Philips Medical Systems North America SRRFMPBV1 Device for monitoring fetal and maternal heartrate and uterin activity User Manual ait fm manual

Philips Medical Systems North America Co. Device for monitoring fetal and maternal heartrate and uterin activity ait fm manual

User manual

Instructions for Use Avalon Fetal MonitorFM20/30, FM40/50, Avalon CLRelease L.3 with Software Revision L.3x.xxPatient Monitoring
31Table of Contents1Introduction 9Who this Book is For 9Confirm Fetal Life Before Using the Monitor 10Introducing the Avalon Family of Fetal Monitors 112What's New 21What's New in Release L.3 21What's New in Release J.3 233Basic Operation 27Supported Measurements 28Avalon FM20 and FM30 29Avalon FM40 and FM50 30Getting to Know Your Avalon FM20/FM30 31Getting to Know Your Avalon FM40/FM50 34Connecting the Monitor to AC Mains 36Wired Transducers 36Operating and Navigating 38Operating Modes 44Automatic Screen Layouts 45Settings 45Preparing to Monitor 48After Monitoring 70Switching the Monitor to the Standby Screen 71Disconnecting from Power 71Power On/Power Off Behavior 71Monitoring After a Power Failure 72Troubleshooting 724Cableless Monitoring 73Avalon CL Transducer System 73Basics of Cableless Systems 74Twins and Triplets Support 75Configuration of Cableless Systems 75Getting to Know Your Avalon CL 76Cableless Transducers 84CL Pods 89Calling Patients 93Telemetry 94Preparing to Monitor Cablelessly 100
4Battery Lifetime Management 106Patient Transport Within the Hospital 107Underwater Monitoring 1085FM20/30 Battery Option 109External Power Supply M8023A 109Using Batteries 110Optimizing Battery Performance 113Storing the Battery 115Cableless Monitoring with FM20/30 Battery Option 116Patient Transport Within the Hospital 1166Alarms 117Alarm Mode 118Nurse Call Systems 118Visual Alarm Indicators 119Audible Alarm Indicators 119Acknowledging Alarms 121Acknowledging Disconnect INOPs 121Alarm Reminder 122Pausing or Switching Off Alarms 122Alarm Limits 124Reviewing Alarms 126Latching Alarms 126Testing Alarms 128Alarm Behavior at Power On 1287Patient Alarms and INOPs 129Alarm Messages 129Technical Alarm Messages (INOPs) 1328Admitting and Discharging 147Admit/Discharge on the Monitor 147New Patient Check 149OB TraceVue/IntelliSpace Perinatal 1499Non-Stress Test Timer 151Setting NST Autostart/Autostop 151Viewing the NST Timer 151Timer Expiry Notification 151Accessing the NST Setup Pop-up Keys 15210 Non-Stress Test Report 153Setting Up an NST Report 153NST Report Status Window 154NST Criteria 157
511 Cross-Channel Verification (CCV) 159Misidentification of Heart Rates 159Cross-Channel Verification Functionality 160Overview of Cross-Channel Comparisons 161Coincidence Examples 162Recommended Actions for Coincidence INOP 16412 Monitoring FHR and FMP Using Ultrasound 165Technical Description 165Limitations of the Technology 166Misidentification of Maternal HR as FHR 166What You Need 166Cableless Monitoring - Important Considerations 167Preparing to Monitor 168Selecting Fetal Heart Sound 169Changing the Fetal Heart Sound Volume 170Fetal Movement Profile 170Troubleshooting 172Additional Information 17313 Monitoring Twin FHRs 183Important Considerations 183Monitoring Twins Externally 184Monitoring Twins Internally 185Separating FHR Traces 185Troubleshooting 18914 Monitoring Triple FHRs 191Important Considerations 191Monitoring Triplets 192Separating FHR Traces 192"Standard" Separation Order 193"Classic" Separation Order 194Switching Trace Separation On and Off 195When Trace Separation is On 195When Trace Separation is Off 195Troubleshooting 19615 Fetal Heart Rate Alarms 197Changing Alarm Settings 197Changing Signal Loss Delay 19816 Monitoring FHR Using DECG 199Misidentification of Maternal HR as FHR 199What You Need 200Making Connections 202
6Monitoring DECG 202Suppressing Artifacts 204Troubleshooting 205Testing DECG Mode 20517 Monitoring Uterine Activity Externally 207What You Need 207External Toco Monitoring 208Toco Sensitivity 208Troubleshooting 20818 Monitoring Uterine Activity Internally 211What You Need 211Internal (IUP) Monitoring 213Troubleshooting 21419 Monitoring aFHR, aHR, and aToco 215Fetal Heart Rate aFHR 215Uterine Activity aToco 216What You Need 217At the Monitor 217Troubleshooting 21820 Monitoring Maternal Heart / Pulse Rate 221Priority for Maternal Heart / Pulse Rate 221Misidentification of Maternal HR for FHR 222Maternal HR from MECG Electrodes 222Monitoring MECG Wave 225Pulse Rate from Toco MP 227Pulse Rate from SpO2 228Adjusting the Heart Rate / Pulse Alarm Limits 228Average Pulse Rate from Noninvasive Blood Pressure 228Testing MECG Mode 22921 Printing the ECG Waveform 23122 Monitoring Noninvasive Blood Pressure 235Introducing the Oscillometric Noninvasive Blood Pressure Measurement 235Preparing to Measure Noninvasive Blood Pressure 237Starting and Stopping Measurements 239Enabling Automatic Mode and Setting Repetition Time 239Enabling Sequence Mode and Setting Up the Sequence 240Choosing the Alarm Source 240Assisting Venous Puncture 241Calibrating NBP 241Troubleshooting 242
723 Monitoring SpO2 243Selecting an SpO2 Sensor 243Applying the Sensor 243Connecting SpO2 Cables 244Measuring SpO2 244SpO2 Signal Quality Indicator (FAST SpO2 only) 245Assessing a Suspicious SpO2 Reading 246Understanding SpO2 Alarms 246Setting Up Tone Modulation 247Setting the QRS Volume 24724 Monitoring Maternal Temperature 249Measuring Tympanic Temperature 249Entering Temperature Manually 25425 Paper Save Mode for Maternal Measurements 25526 Recovering Data 257Recovering Traces on Paper 257Recovering Traces on an OB TraceVue/IntelliSpace Perinatal System 258Manually Recording Stored Data 25827 Care and Cleaning 261General Points 261Cleaning and Disinfecting 262Cleaning and Disinfecting Monitoring Accessories 263Cleaning and Disinfecting the Tympanic Temperature Accessories 264Cleaning and Disinfecting CL Transducers and CL Pods 264Sterilizing 26528 Maintenance 267Inspecting the Equipment and Accessories 267Inspecting the Cables and Cords 268Maintenance Task and Test Schedule 268Recorder Maintenance 269Cleaning the Print Head 273Returning Equipment for Repair 273Disposing of the Monitor 27429 Accessories and Supplies 275Information on Latex 275Avalon CL Base Station 275Transducers 276Fetal Accessories 276Noninvasive Blood Pressure Accessories 278SpO2 Accessories 280
8Tympanic Temperature Accessories 285Recorder Paper 285Batteries 28530 Specifications and Standards Compliance 287Environmental Specifications 287Physical Specifications 289Interface Specifications 293Performance Specifications 295Recorder Specifications 308External Displays: FM40/FM50 Only 310Manufacturer's Information 310Trademark Acknowledgment 310Regulatory and Standards Compliance 311Environment 321Monitoring After a Loss of Power 321ESU, MRI, and Defibrillation 321Cardiac Pacemakers and Electrical Stimulators 322Fast Transients/Bursts 322Symbols on the System 32231 Default Settings Appendix 327Alarm and Measurement Default Settings 327Recorder Default Settings 330Index 333
191IntroductionWho this Book is ForThis book is for trained healthcare professionals using the Avalon FM20, FM30, FM40, and FM50 fetal/maternal monitors, and the Avalon CL Transducer System. It describes how to set up and use the monitor and transducers. Familiarize yourself with all instructions including warnings and cautions before starting to monitor patients. Read and keep the Instructions for Use that come with any accessories, as these contain important information about application, care, and cleaning that is not repeated in this book.If you have received this Instruction for Use because your fetal monitor has been upgraded to a newer software version L.3, be aware that the standards compliance information contained in the Instructions for Use for L.3 does not apply to your fetal monitor. Refer to your original Instructions for Use for standards compliance information.You should be:• Trained in the use of fetal heart rate (FHR) monitors.• Trained in the interpretation of FHR traces.• Familiar with using medical devices and with standard fetal monitoring procedures.For information on how to configure and service the monitor, see the Configuration Guide and the Service Guides, or contact your authorized service provider.Your monitor may not have all of the features and options described in this guide. The exact appearance of the monitor may differ slightly from that shown in the illustrations.This guide may contain descriptions of functionality and features that are not implemented in the equipment currently shipped to Japan and/or of products that are not currently sold in Japan due to limitations and restrictions under the applicable local laws and regulations in Japan. Please contact your local sales representative and/or Philips Customer Support for details.In this guide:•A warning alerts you to a potential serious outcome, adverse event, or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.•A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in:– minor or moderate personal injury,– damage to the product or other property,– possibly in a remote risk of more serious injury.
1 Introduction10•Monitor refers to the entire fetal/maternal monitor. Display refers to the physical display unit. Screen refers to everything you see on the monitor's display, such as measurements, alarms, patient data, and so forth.FM30 • Whenever a monitor’s identifier appears to the left of a heading or paragraph, it means that the information applies to that monitor only. Where the information applies to all models, no distinction is made.Avalon CLAvalon CTS Whenever one of these identifiers appear to the left of a heading or paragraph, it means that the information applies to that cableless transducer system. Where the information applies to both systems, no distinction is made.For installation instructions and technical description, see the corresponding Service Guide of the fetal monitors.Confirm Fetal Life Before Using the MonitorFetal monitoring technology available today is not always able to differentiate a fetal heart rate (FHR) signal source from a maternal heart rate (MHR) source in all situations. Therefore, you should confirm fetal life by independent means before starting to use the fetal monitor, for example, by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope. If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography. Continue to confirm that the fetus is the signal source for the FHR during monitoring.Be aware that:• a maternal HR trace can exhibit features that are very similar to those of an FHR trace, even including accelerations and decelerations. Do not rely solely on trace pattern features to identify a fetal source.• Fetal Movement Profile (FMP) annotations on a fetal trace alone may not always indicate that the fetus is alive. The body of a deceased fetus can move and cause the monitor to annotate fetal body movements.Here are some examples where the maternal HR can be misidentified as the FHR.When using an ultrasound transducer:• It is possible to pick up maternal signal sources, such as the aorta or other large vessels.• Misidentification may occur when the maternal HR is higher than normal (especially when it is over 100 bpm).When using a fetal scalp electrode:• Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode cable, appearing to be a fetal signal source.• The recorded maternal HR (and any artifact) can be misinterpreted as an FHR (especially when it is over 100 bpm).When Fetal Movement Profile (FMP) is enabled:FMP annotations in the absence of fetal life may be a result of:• Movement of the deceased fetus during or following maternal movement.• Movement of the deceased fetus during or following manual palpation of fetal movement (especially if the pressure applied is too forceful).
1 Introduction11• Movement of the ultrasound transducer.• The ultrasound transducer detecting a maternal movement source, such as the mother coughing.See also “Monitoring FHR and FMP Using Ultrasound” on page 165 and “Monitoring FHR Using DECG” on page 199.To reduce the possibility of mistaking the maternal HR for an FHR, it is recommended that you monitor both maternal and fetal heart rates. The monitor's cross-channel verification (CCV) feature can help by automatically detecting when a maternal HR coincides with an FHR. For further details, see “Cross-Channel Verification (CCV)” on page 159.Introducing the Avalon Family of Fetal MonitorsThe Avalon family of fetal monitors consists of the Avalon FM20, FM30, FM40, and FM50. While the FM20/FM30 and the FM40/FM50 have different form factors, the method of operation is very similar for all monitors. The Avalon fetal monitors also share transducers, accessories, software, and are compatible with the Avalon CL, and Avalon CTS Fetal Transducer Systems.Intended UseThe Philips Avalon FM20 (M2702A), FM30 (M2703A), FM40 (M2704A), and FM50 (M2705A) fetal/maternal monitors are intended for:• noninvasive monitoring of fetal heart rates and movements.• noninvasive monitoring of maternal heart rates, maternal pulse rates, uterine activity, maternal noninvasive blood pressure, maternal oxygen saturation, and maternal temperature.• invasive monitoring of direct fetal heart rate, intrauterine pressure, and for displaying and recording of fetal and maternal electrocardiogram (ECG) (FM30 and FM50 only).• displaying, storing, and recording patient data and parameter values, and for generating alarms from fetal and maternal parameters.• transmitting patient data and parameter values to a patient information and surveillance system.• use by trained health care professionals.• use in antepartum testing areas, in labor and delivery rooms, and during postpartum recovery in the hospital environment. They are not intended for use in intensive care units or operating rooms.• monitoring in a bath or shower (Avalon CL cableless transducers Toco+ MP, Ultrasound, and ECG/IUP only).• transport situations in healthcare facilities, for healthcare facilities outside hospitals, such as doctors’ offices, and for use in private households (FM20 and FM30 only).
1 Introduction12WARNINGThe fetal/maternal monitors are not intended for:• use during defibrillation, electro-surgery, or magnetic resonance imaging (MRI).• Electrocardiography (ECG) measurements on patients connected to electrical stimulator or with cardiac pacemakers.• use of the invasive measurements IUP and fetal DECG, use of the patient module (M2738A) and use of the Avalon CL system in domestic establishments, and those connected directly to the public low-voltage supply network that supplies buildings used for domestic purposes.• measuring the maternal temperature using the tympanic thermometer (866149) in private households.WARNINGNo modification of the fetal monitors, transducers, and the Avalon CL base station is allowed.CAUTIONU.S. federal law restricts this device to sale by, or on the order of, a physician.All users must read the Instructions for Use before working with the fetal monitor. Disregarding the contents of the Instructions for Use is considered abnormal use.
1 Introduction13Indications for UseAvalon Fetal/Maternal Monitor FM20Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.Avalon Fetal/Maternal Monitor FM30Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, and pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities.Avalon Fetal/Maternal Monitor FM40Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, oxygen saturation, noninvasive blood pressure, and pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.Avalon Fetal/Maternal Monitor FM50Indicated for use by trained health care professionals whenever there is a need for monitoring the physiological parameters uterine activity, heart rate, electrocardiography (ECG), oxygen saturation, noninvasive blood pressure, and pulse rate, and temperature of pregnant women, and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.Safety InformationIn this guide:• A warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to the user or patient.• A caution alerts you to where special care is necessary for the safe and effective use of the product. Failure to observe a caution may result in minor or moderate personal injury or damage to the product or other property, and possibly in a remote risk of more serious injury.
1 Introduction14Electrical HazardsWARNINGElectrical shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel.• Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket.• Do not use AC mains extension cords or multiple portable socket-outlets.•FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock.• Do not connect any devices that are not supported as part of a system.• Any non-medical device placed and operated in the patient’s vicinity must be powered with an approved isolation transformer that ensures mechanical fixing of the power cords, and covering of any unused power outlets.• The fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result.• Do not touch the charging contacts for the cableless transducers at the Avalon CL base station while you are touching the patient.Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits.Radio Frequency InterferenceWARNING• Short range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n), and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor) on the IntelliVue CL NBP or CL SpO2 Pods, or a No Host Monitoring, or cl NBP Disconnect, or cl SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, refer to the Service Guides and the Configuration Guide for details.• To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers.• This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case the users must take whatever measures may be required to correct the interference.• Do not use cordless/mobile phones or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.
1 Introduction15• For paced patients: The radiated SRR power of the CL SpO2, CL NBP Pods, CL F&M Pod, and the CL Wide Range Pod, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients.• In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products.Use EnvironmentWARNINGExplosion Hazard:• Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard.• Use only Philips batteries part number M4605A with the FM20 or FM30 with battery option. Use of a different battery may present a risk of fire or explosion.Environmental Specifications:• The performance specifications for the monitors, measurements, and accessories apply only for use within the temperature, humidity, and altitude ranges specified in “Environmental Specifications” on page 287.Liquid Ingress:• Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel, or Philips service engineer.• Never immerse the fetal monitor or the CL base station in liquid. You must protect them against water sprays or splashes. Place the fetal monitor and the CL base station where there is no chance of contact with, or falling into water or other liquids.• Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers.• The CL Fetal & Maternal Pod is not intended for underwater monitoring. The contacts between the CL Fetal & Maternal Pod and the electrode patch have to be kept dry at all times. The CL Fetal & Maternal Pod mounted on the electrode patch, can be worn underneath a shower, as long as the CL Fetal & Maternal Pod stays mounted. Radio transmissions in the shower may be compromised.Heat Exposure:• Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers, and heating lamps.• Do not put equipment or accessories in autoclave (for sterilization).Positioning Equipment:• The device should not be used adjacent to, or stacked with, other equipment unless otherwise specified.
1 Introduction16Prohibited Environments:• The monitors and their transducers, Pods, and accessories are not intended for use in an MRI environment or in an oxygen-enriched environment (for example, hyperbaric chambers).AlarmsWARNING• Do not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment.• Alarm systems of the monitor and those of the connected obstetrical information and surveillance system are independent and not synchronized.•In INOP only mode, no fetal/maternal patient alarms are enabled or indicated.AccessoriesWARNINGPhilips' approval: Use only Philips-approved accessories. Using non-Philips-approved accessories may compromise device functionality and system performance, and cause a potential hazard.Reuse: Never reuse disposable transducers, sensors, accessories, and so forth, that are intended for single use, or single patient use only. Reuse may compromise device functionality and system performance, and cause a potential hazard.Electromagnetic compatibility: The use of accessories, transducers, and cables other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the device.Damage: Do not use a damaged sensor or one with exposed electrical contacts.Cables and tubing: When connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation.
1 Introduction17Security InformationProtecting Personal InformationProtecting personal health information is a primary component of a security strategy. Each facility using the monitors must provide the protective means necessary to safeguard personal information consistent with country laws and regulations, and consistent with the facility’s policies for managing this information. Protection can only be realized if you implement a comprehensive, multi-layered strategy (including policies, processes, and technologies) to protect information and systems from external and internal threats.As per its intended use, the patient monitor operates in the patient vicinity and contains personal and sensitive patient data. This also includes the trace print-outs at the monitor.The monitor also includes controls to allow you to adapt the monitor to the patient's care model.To ensure the patient's safety and protect their personal health information, you need a security concept that includes:•Physical security access measures - access to the monitor must be limited to authorized users. It is essential that you consider physical security measures to ensure that unauthorized users cannot gain access.•Operational security measures - for example, ensuring that patients are discharged after monitoring in order to remove their data from the monitor.•Procedural security measures - for example, assigning only staff with a specific role the right to use the monitors.In addition, any security concept must consider the requirements of local country laws and regulations.Always consider data security aspects of the network topology and configuration when connecting patient monitors to shared networks. Your medical facility is responsible for the security of the network, where sensitive patient data from the monitor may be transferred.When a monitor is returned for repair, disposed of, or removed from your medical facility for other reasons, always ensure that all patient data is removed from the monitor by ending monitoring for the last patient (see “Discharging a Patient” on page 148). Also select Erase All in the Stored Data Recording menu, to erase all stored data.NOTELog files generated by the monitors and measurement modules are used for system troubleshooting and do not contain protected health data.About HIPAA RulesIf applicable, your facility’s security strategy should include the standards set forth in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), introduced by the United States Department of Health and Human Services. You should consider both the security and the privacy rules and the HITECH Act when designing policies and procedures. For more information, please visit: http://www.hhs.gov/ocr/privacy/
1 Introduction18About the EU DirectivesIf applicable, your facility’s security strategy should include the practices set forth in the Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995). In addition, your facility should also take into account any additional, more stringent standards put forward by any individual EU countries; that is, Germany, France, and so on.Philips Product Security Policy StatementAdditional security and privacy information can be found on the Philips product security web site at: http://www.healthcare.philips.com/main/support/equipment-performance/product-security/index.wpdManufacturer Disclosure Statement for Medical Device Security – MDS2You can view the Manufacturer Disclosure Statements for Medical Device Security (MDS2) for specific devices at: http://www.healthcare.philips.com/main/support/equipment-performance/product-security/index.wpdOverview of System ComponentsThe Avalon CL system consists of the Avalon CL base station, the Avalon CL transducers, the Avalon CL Fetal & Maternal Pod, the CL Wide Range Pod, and the IntelliVue CL Pods.The IntelliVue CL Pods are only used for maternal measurements within the Avalon CL solution. The following table provides an overview of all the devices.Avalon FM20/FM30 and FM40/FM50 Wired TransducersAvalon CL Base Station Avalon CL TransducersCL PodsFM20/FM30M2702A and M2703AFM40/FM50M2704A and M2705AAvalon CL Base Station866074
1 Introduction19US transducer (wired)M2736AAvalon CL US Transducer (cableless)866076Avalon CL Fetal & Maternal Pod866488Toco/ Toco MP transducer (wired)M2734A and M2734BAvalon CL Toco+ MP Transducer (cableless)866075Avalon CL Wide Range Pod866487Avalon FM20/FM30 and FM40/FM50 Wired TransducersAvalon CL Base Station Avalon CL TransducersCL Pods
1 Introduction20Toco+ transducer with ECG/IUP capability (wired)M2735AAvalon CL ECG/IUP Transducer (cableless)866077IntelliVue CL NBP Pod (cableless)865216Patient Module for ECG/IUPM2738AIntelliVue CL SpO2 Pod (cableless)865215Avalon FM20/FM30 and FM40/FM50 Wired TransducersAvalon CL Base Station Avalon CL TransducersCL Pods
2212What's NewThis section lists the most important new features and improvements to the fetal monitors and their user interface introduced with Release L.3.You may not have all of these features, depending on the fetal monitor configuration purchased.What's New in Release L.3Avalon CL Fetal & Maternal PodThe Avalon CL Fetal & Maternal Pod is an extension of the Avalon CL solution. The Avalon CL Fetal & Maternal Pod is used together with a single use patch with five abdominal electrodes. Prior to use, the Avalon CL Fetal & Maternal Pod is charged and assigned at the Avalon CL base station. The Avalon CL Fetal & Maternal Pod is used with singleton pregnancies. This solution provides especially benefits to patients with high body mass index (BMI), although it can be used for all patients.The Avalon CL Fetal & Maternal Pod includes the following features:• The Avalon CL Fetal & Maternal Pod measures fetal heart rate (aFHR), maternal heart rate (aHR), and uterine activity (aToco) from electrical signals.•The cl F&M Electrode Status window at the monitor gives an overview of the current electrode contact status, when the CL Fetal & Maternal Pod is placed on the electrode patch, and the patch, and the electrodes are applied to the patient's abdominal skin. The window can be opened by selecting the new SmartKey cl F&M Status, or selecting the corresponding function in the main setup menu.• The Avalon CL Fetal & Maternal Pod and the CL Wide Range Pod are assigned at the CL base station in the same easy way as the IntelliVue CL Pods.• The functions Finder LED and Call Patient work also with the Avalon CL Fetal & Maternal Pod.See “Avalon CL Fetal & Maternal Pod” on page 21, “CL Fetal & Maternal Electrode Patch” on page 91, “Applying the CL Fetal & Maternal Patch and Pod” on page 100, and “CL Pod Assignment” on page 99.
2 What's New22Avalon CL Wide Range PodThe Avalon CL Wide Range Pod is an extension of the Avalon CL solution. The Avalon CL Wide Range Pod extends the signal range of the cableless measurements. It transmits the cableless measurement signals via the hospital WLAN/WiFi to the fetal monitors. Wearing the CL Wide Range Pod, the patient can walk freely within the hospital's WLAN/WiFi range during monitoring. Prior to use, the Avalon CL Wide Range Pod is charged and assigned at the Avalon CL base station.• A new WLAN symbol is printed on the trace to indicate the use of an assigned and active Avalon CL Wide Range Pod.• During monitoring with an active Avalon CL Wide Range Pod, the sound from the fetal heart rate is replaced by an artificial QRS sound (when the patient is monitored with a CL US transducer or CL F&M Pod).See “CL Wide Range Pod” on page 91.Dawes/RedmanDawes/Redman is a method of fetal monitoring trace interpretation for helping to assess fetal well-being. The algorithm based on the Dawes/Redman criteria uses the parameters fetal heart rate, gestational age, fetal movement, accelerations and decelerations, and long, and short term variability to generate a report.Not available in the USA and territories relying on FDA market clearance.Support of XDS Remote DisplayThe fetal monitor software supports the IntelliVue XDS “Remote Display” functionality only in combination with IntelliSpace Perinatal revision K or higher. From the user interface of the IntelliSpace Perinatal system, you can access all screen-operable functions of the currently connected fetal monitor. These functions include for example, starting and stopping physiological measurements, changing measurement modes, changing alarm limits, and silencing alarms.New Alarm Behavior of CL Battery Empty INOPThe CL <xxx> Battery Empty INOP issued by the CL devices and the fetal monitor has a new alarm behavior:• At the fetal monitor, it is issued now with a cyan INOP alarm and tone.• At CL devices (CL transducers and CL Pods), it is issued now with a tone.See “Patient Alarms and INOPs” on page 129.Using CL Pods with FM20/30 #E25The CL Pods can now also be used with a battery operated FM20 or FM30 (option #E25). The CL Pods can be assigned and activated. The CL F&M Pod can also be charged.See “Using Batteries” on page 110.Entering Notes - Type a NoteIn the menu Enter Note, it is now possible to enter a note manually, instead of selecting one of the pre-configured notes. To enter a note, select the new menu item Type a note. A window with a touch keypad opens. The typed note can be up to 30 characters long.See “Typing Notes” on page 70.
2 What's New23What's New in Release J.3Avalon CL Transducer SystemThe Avalon CL Transducer System provides cableless monitoring with the Avalon FM20/FM30 and FM40/FM50 with the same functionality and performance as the wired measurement devices (e.g. twin and triplets monitoring). The Avalon CL Transducer System has a straight-forward handling and operating concept. The CL transducers are assigned by simply docking them at the CL base station, no further configuration is necessary.The Avalon CL Transducer System includes the following features:• Cableless monitoring of twins and triplets (see “Monitoring Twin FHRs” on page 183 and “Monitoring Triple FHRs” on page 191)• Cableless maternal measurement Pods CL SpO2 and CL NBP (see “IntelliVue CL Pods” on page 92)• Maternal pulse from a CL Toco+ MP (Smart Pulse) transducer (see “Monitoring Maternal Heart / Pulse Rate” on page 221)• A cableless ECG/IUP transducer measuring IUP or fetal/maternal ECG (see “Monitoring MECG Wave” on page 225 and “Monitoring FHR Using DECG” on page 199)• Watertight cableless transducers that can be used to monitor in water (see “Underwater Monitoring” on page 108)• Patient call that pages an ambulating mother with an audible signal emitted by the worn CL transducers (see “Calling Patients” on page 93)• Out-of-range audible signal emitted by the worn CL transducers to inform an ambulating mother that she has reached the limit of the active signal area-of-reach (see “Standard Radio Range of CL Transducers” on page 87)• A transducer finder LED on all CL transducers to help identify the assigned transducer (see “Cableless Transducer LED Indication” on page 86)Support For Use of Maternal Cableless Measurement DevicesThe IntelliVue CL measurement Pods are patient-worn, battery-powered measurement devices for SpO2 and NBP. The devices provide measurement values on the built-in display and communicate them to the fetal monitor using the wireless short range radio (SRR) interface of the Avalon CL base station (see “IntelliVue CL Pods” on page 92).Maternal Temperature MeasurementTo measure maternal temperature, the new optional tympanic thermometer (866149) is available for the Avalon fetal monitors (“Monitoring Maternal Temperature” on page 249). The measurement data is:• documented and printed out at the local recorder, and transmitted to the obstetrical information and surveillance system.• displayed as a numeric on the screen.
2 What's New24Manually Entered Maternal Temperature MeasurementsManually measured temperatures can be entered at the fetal monitor. They are displayed as a numeric on screen, and are printed out on the recorder trace (“Monitoring Maternal Temperature” on page 249).SpO2 Recordings and TransmissionsSpO2 annotation on local recorderYou can now configure the interval for printing the SpO2 numeric values on the recorder trace. With the new configuration setting Record on Trace, you can set the interval to 1 or 5 minutes.SpO2 transmission to an obstetrical information and surveillance systemYou can now configure the interval for transmitting the SpO2 numeric values to an obstetrical information and surveillance system. With the new configuration setting Send to OB Sys, you can set the interval to 1 or 5 minutes.New Design for the User InterfaceThe user interface for the fetal monitors has been redesigned to bring the presented information into the foreground, letting the structural elements such as keys and frames retreat into the background. Additionally special regard was given to making the "look and feel" similar to that of standard software products (see “Operating and Navigating” on page 38).New SmartKeys•The Start ECG SmartKey and menu item is renamed to Record ECG.• With the Call Patient SmartKey, you can now page patients who are ambulating wearing Avalon CL transducers.• With the Tele Info SmartKey, you can call up the Tele Info window on the fetal monitor display. In the Tele Info window, you can control and view the status of the cableless transducers from the connected Avalon CL base station.• With the Enter Temp SmartKey, a pop-up window opens showing a numeric pad for entering manually measured maternal temperature values.• With the NBP Modes SmartKey, you can access the NBP Mode selection and setup, and can directly start and stop a measurement.• With the QuickAdmit SmartKey, you can quick admit a patient to the monitor.All new SmartKeys are optional, and have to be configured in Configuration Mode for use (see “SmartKeys” on page 42).Coincidence INOP ToneWhen the cross-channel verification detects that the signal of the maternal heart rate coincides with the fetal heart rate, the Coincidence INOP is now issued with a tone at the fetal monitor. The Coincidence INOP tone has a configurable delay see “Cross-Channel Verification (CCV)” on page 159.
2 What's New25Increased Internal Back-up MemoryThe internal back-up memory is now able to store traces and data from at least the last 3.5 hours with the software revision J.3, and minimum 7 hours with the new mainboard hardware revision A 00.18 (see “Manually Recording Stored Data” on page 258 and “Recovering Data” on page 257).Dual System Interface SupportIf the fetal monitor is connected via a LAN connection to OB TraceVue/IntelliSpace Perinatal, the RS232 interface can be used independently to connect e.g. an EMR system on read-only basis. The system connected to the RS232 interface in this case cannot alter any data (such as ADT data, or the date and time setting), or interfere with functions of the monitor, but is able to read output data. The obstetrical information and surveillance system connected via LAN has priority.USB InterfaceAn optional USB interface allows the use of bar code readers and input devices such as a keyboard, or mouse (see “Getting to Know Your Avalon FM20/FM30”/“Bottom” on page 32 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 33).Flexible Nurse Call InterfaceAn optional Flexible Nurse Call interface allows the connection of a nurse call device to the fetal monitors (see “Getting to Know Your Avalon FM20/FM30”/“Bottom” on page 32 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 33).DHCP SupportThe DHCP support offers an alternative to BOOTP. DHCP (Dynamic Host Configuration Protocol) enables the fetal monitors to request an IP address (internet protocol address) from the connected network (OB TraceVue/IntelliSpace Perinatal) automatically.Data Export SupportYou can now export measurement values from the monitor to other devices via the LAN interface, or with the optional MIB RS232 interface (see “Getting to Know Your Avalon FM20/FM30”/“Bottom” on page 32 and “Getting to Know Your Avalon FM40/FM50”/“Rear” on page 33).NBP Configurable Measurement SequenceUp to four measurement cycles can be set up which will run consecutively. For each cycle, you can set the number of measurements and the interval between them. By setting the last cycle to run continuously, you can have regular measurements continue after the sequence has run (see “Enabling Sequence Mode and Setting Up the Sequence” on page 240.Alarms EnhancementsIn addition to the standard cyan INOPs, some INOPs can now be configured as red or yellow INOPs to provide a severity indication (ECG Leads Off, Cuff Overpress, Cuff NotDeflated, Battery Empty, No Pulse) (see “Alarms” on page 117).
2 What's New26Alarm ReminderIn Configuration Mode, you can set now an Alarm Reminder. The Alarm Reminder emits an audible reminder of alarm conditions that remain active after the alarm is acknowledged. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). The interval between silencing the alarm and sounding the reminder tone can be set to one, two, or three minutes (see “Alarm Reminder” on page 122).Auto FreeIn Configuration Mode, you can now set an Auto Free setting which discharges a patient automatically when the fetal monitor has been powered off, or is in standby mode for a set time. Only the demographic patient data is deleted, the trace data is not affected.
3273Basic OperationThis chapter gives you an overview of the monitor and its functions. It tells you how to perform tasks that are common to all measurements (such as entering data, switching on a measurement, changing some monitor settings, and setting up the recorder). The alarms section gives an overview of alarms. The remaining sections tell you how to perform individual measurements, and how to care for and maintain the equipment.
3 Basic Operation28Supported MeasurementsDifferent measurements for the same physiological parameter may have a different appearance on the trace, due to: variability (HR), averaging, delay, amplitude, or artifacts. Before interpreting the trace, regard the fetal monitor setup and transducers used.The following Fetal measurements are supported:The following Maternal measurements are supported:Measurements FM20 FM30 FM40 FM50Fetal Heart Rate (FHR) via US (including Twins)Standard Standard Standard StandardTriple FHR via US Optional Optional Optional OptionaldFHR via Direct ECG (DECG)- Standard - StandardaFHR via CL F&M Pod Optional Optional Optional OptionalToco Standard Standard Standard StandardaToco via CL F&M Pod Optional Optional Optional OptionalIntrauterine Pressure (IUP) - Standard - StandardMeasurements FM20 FM30 FM40 FM50Maternal Heart Rate (MHR) via Maternal ECG ElectrodesStandard Standard Standard StandardMaternal ECG (MECG wave) - Standard - StandardaHR via CL F&M Pod Optional Optional Optional OptionalMaternal Pulse from Toco Standard Standard Standard StandardNoninvasive Blood Pressure with Pulse RateOptional Optional Optional OptionalPulse Oximetry (Maternal SpO2) with Pulse RateOptional Optional Optional OptionalMaternal Temperature Optional Optional Optional Optional
3 Basic Operation29Avalon FM20 and FM30This section outlines the capabilities of your monitor.Avalon FM20The Avalon FM20 fetal/maternal monitor provides a solution for external fetal monitoring applications, and optional noninvasive maternal vital signs.You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity and maternal pulse using an external Toco transducer, and the maternal heart rate (MHR) with maternal ECG electrodes, and optionally, noninvasive blood pressure and maternal oxygen saturation (SpO2).Measurements are displayed on a 6.5 inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations.You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system via the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later).Avalon FM30The Avalon FM30 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and optional noninvasive maternal vital signs.The Avalon FM30 shares all the features and capabilities of the Avalon FM20. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), uterine activity internally using an intrauterine pressure (IUP) catheter together with a Toco+ transducer or patient module.The Avalon FM30 carries the IP label, indicating that it is capable of intrapartum monitoring.
3 Basic Operation30FM20/30 with BatteryOption #E25 OnlyThe battery option for the FM20/30 provides support for the in-transport monitoring of all measurements when disconnected from a power supply. Existing data storage is automatically uploaded to OB TraceVue or IntelliSpace Perinatal after reconnecting it to the system. Trace printing during transport is also possible.Avalon FM40 and FM50This section outlines the capabilities of your monitor.Avalon FM40The Avalon FM40 fetal/maternal monitor provides a solution for external fetal monitoring applications, and noninvasive maternal vital signs.You can monitor fetal heart rates (FHRs) externally using ultrasound, uterine activity using an external Toco transducer, and the maternal heart rate (MHR) via maternal ECG electrodes, and noninvasive blood pressure and maternal oxygen saturation (SpO2).Measurements are displayed on a 6.5 inch color display as numerics. The display is a touchscreen, and you operate the monitor using this touchscreen interface. The integrated recorder documents fetal and maternal measurements as well as the user-defined annotations.You can connect the monitor to an OB TraceVue/IntelliSpace Perinatal system with the RS232 connection, or over a LAN connection (with OB TraceVue Revision E.00.00 and later, or IntelliSpace Perinatal Revision H.0 and later).
3 Basic Operation31Avalon FM50The Avalon FM50 fetal/maternal monitor offers a solution for both external and internal fetal monitoring applications, and noninvasive maternal vital signs.The Avalon FM50 shares all the features and capabilities of the Avalon FM40. In addition, you can monitor one FHR internally with a direct fetal electrocardiogram (DECG), and uterine activity internally using an intrauterine pressure (IUP) catheter together with a Toco+ transducer or patient module.The Avalon FM50 carries the IP label, indicating that it is capable of intrapartum monitoring.Getting to Know Your Avalon FM20/FM30OverviewRight Side1Touchscreen display (tilt and fold)2Power LED3Paper drawer4Paper drawer release5Connectors1On/Off switch2Power connector
3 Basic Operation32with Battery OptionLeft SideEach of the fetal sensor sockets accepts any fetal transducer, one Avalon CL or one Avalon CTS Cableless Fetal Transducer System base station, or an event marker.BottomThere are five optional interfaces available for the Avalon FM20/30 monitor:• LAN/RS232 system interface• Dual PS/2 interface• Dual MIB/RS232 interface• Flexible Nurse Call interface• USB ports interface1On/Standby button with power LED2MSL connector for external power supply1SpO2 socket (optional)2Noninvasive Blood Pressure socket (optional)3Fetal sensor sockets
3 Basic Operation33You can use two of the five optional interfaces at the same time.Rear1LAN/RS232 system interface2Dual PS/2 system interfaceOptional Interfaces DescriptionFlexible nurse call interface cardQuad. USB portsDual MIB/RS2321Display release2Carrying handle3Built-in stand
3 Basic Operation34Getting to Know Your Avalon FM40/FM50FrontConnect any fetal sensor or patient module at the fetal sensor sockets, including an Avalon CL or an Avalon CTS via interface cable (with red connector).1Touchscreen color display2Transparent paper guide with tear-off edge3Paper eject button4Power LED5On/Standby button6Recorder paper table7Fetal sensor sockets8Noninvasive blood pressure socket (optional)9SpO2 socket (optional)
3 Basic Operation35RearTwo Avalon CL base stations, or one Avalon CTS can be also connected to the Telemetry interface sockets using the interface cable (with black connector).Additional Optional Interfaces1Reserved for future use: protective earth intended for use in system installations2Equipotential grounding point3Power cord connector4Loudspeaker5Slot 01 for optional LAN/RS232 system interface (for connection to an obstetrical information and surveillance system)6Slot 03 reserved for future use7Video output (VGA)8Telemetry interface9Slot 02 for optional interfaces: Either dual PS/2 system interface (A) for mouse and keyboard connection) Or MIB interface (B) for external touchscreen connection, or the optional interfaces for the flexible nurse call or USB portsOptional Interfaces DescriptionFlexible nurse call interface cardQuad. USB portsDual MIB/RS232 interface
3 Basic Operation36Connecting the Monitor to AC MainsWARNING• Always use the supplied power cord with the earthed mains plug to connect to an earthed AC mains socket. Never adapt the mains plug from the fetal monitor to fit an unearthed AC mains socket.• Check that the line frequency is correctly configured in the Global Settings menu.•FM20/FM30 only: The protective earth conductor is required for EMC purposes. It has no protective function against electric shock. Double and/or reinforced insulation protects this device against electric shock.• Do not use AC mains extension cords or multiple portable socket-outlets.Always ensure that the monitor is positioned so that the AC mains plug is easily accessible, to allow disconnection of the monitor from the AC mains.Wired TransducersToco (M2734A) and Toco MP Transducer (M2734B)1Transducer finder LED - lights up on the transducer supporting to identify the measurement source2"MP" for M2734B "Toco MP" transducers (additionally capable of providing the maternal pulse measurement)3Belt button
3 Basic Operation37Ultrasound Transducer (M2736A)1Cable - connects to any of the four fetal sensor sockets on the monitorThe M2736AA US transducer is identical to the M2736A US transducer, including all specificationsToco+ Transducer with ECG/IUP capability (M2735A)1Connector - for connecting ECG/IUP adapter cables (M2735A Toco+ transducer only)1Butterfly belt clip (shown fitted; for use with belts without button holes)2Close-up of MECG adapter cable connected to Toco+ transducer3Close-up of active finder LEDPatient Module for ECG/IUP (M2738A)1Connector - for connecting ECG/IUP adapter cables (same as for Toco+ transducer)2Cable - connects to any of the four fetal sensor sockets on the monitor
3 Basic Operation38Operating and NavigatingYour monitor has a touchscreen. Everything you need to operate the monitor, except the on and off switch, is contained on its screen. Most screen elements are interactive. Screen elements include measurement numerics, screen keys, information fields, status indicators, alarms fields, and menus.Operator PositionThe typical operator's position is in front of the monitor.FM40/50 If an optional external touch display is connected to the monitor, you can operate the monitor using the external touch display.CAUTIONThe screen contains sensitive personal data. For information how to protect personal information, see “Protecting Personal Information” on page 17.1Monitor information line2Measurement area3Key area
3 Basic Operation39Screen ElementsMonitor Information Line1LAN connection status indicator only. RS232 system connection is not indicated. The locomotive icon indicates if the fetal monitor is connected to OB TraceVue/IntelliSpace Perinatal, via a LAN cable or not.2Patient identification3Date and time4Bed label (when connected to a Philips OB TraceVue/IntelliSpace Perinatal system)5Fetal heart sound volume adjust/indicator6Alarm volume adjust/indicator7INOP and alarm status area - shows active alarm messages
3 Basic Operation40Measurement Area1Antenna symbol (indicates a cableless measurement from a connected Avalon CL or Avalon CTS system)2Configurable alarm limits3NST test4Audio source symbol5Measurement numeric6Alarms off symbol7Fetal trace recorder - status indicator8Avalon CL or Avalon CTS system - status indicator9Battery status indicator10 Status line - shows status and prompt messages11 Signal quality indicator: good, acceptable, poor12 Fetal heart rate measurement label13 Measurement unit (configurable)14 Coincidence symbol (see “Cross-Channel Verification (CCV)” on page 159)15 NST timer, if configured (default is Off)
3 Basic Operation41Screen DetailsKey AreaIcon DescriptionThe antenna symbol indicates a cableless measurement (Avalon CL or Avalon CTS).Indicates a short range radio measurement (CL Pods).Signal quality indicator:1Good2Acceptable3PoorFetal trace recorder - status indicatorFetal recorder is onFetal recorder is off (when Paper Save Mode is off)Fetal recorder is off (when Paper Save Mode is on)There is a user-solvable recorder error (paper out, paper jam, wrong paper scale set)Fetal recorder is defective: call serviceWhen an Avalon CL or Avalon CTS system is connected to the monitor, a CL symbol is shown. It changes with the states of the connected cableless device see “Cableless Status Indication” on page 95.1SmartKeys - these can vary according to your monitor's configuration2Main Screen - closes all open menus and windows and returns to main screen3Scroll to display more SmartKeys4Silence - acknowledges all active alarms by switching off audible alarm indicators
3 Basic Operation42KeysThe monitor has three different types of keys.Permanent KeysA permanent key is a graphical key that remains permanently on the screen, giving you fast access to functions.SmartKeysSmartKeys are configurable graphical keys, located at the bottom of the main screen. They give you fast access to functions. The selection of SmartKeys available on your monitor depends on your monitor configuration, and on the options purchased.Key Name FunctionSilenceAcknowledges all active alarms by switching off audible alarm indicators.Main ScreenCloses all open menus and windows and returns to the main screen.SmartKey Name FunctionFRStart/StopTurns the trace recorder on or offStart RecTurns the trace recorder onStop RecTurns the trace recorder offPaper AdvanceAdvances the paper automatically to the next foldSet MarkerMarks an eventEnter NotesEnters notesRecord ECGStarts printing the MECG, DECG, or both waves, when both are availableStored RecPrints trace data from the monitor's memoryNST ReportInitiates an NST trace interpretation and obtains a Non-stress test (NST) reportSound Vol. UpIncreases the fetal heart rate volumeSound Vol. DownDecreases the fetal heart rate volumeToco/IUP BslResets Toco baselineTele InfoCalls up the Tele Info window
3 Basic Operation43Call PatientPages the patient. Only enabled if at least one CL transducer is currently activecl F&M StatusCalls up the cl F&M Electrode Status windowPause AlarmsPauses alarm indicators. Pause duration depends on monitor configuration. If the pause duration is infinite, this key is labeled Alarms OffSelect again to immediately re-enable alarm indicatorsDefaultsLoads User DefaultMain Setup Enters main setup menuStrt/Stp NBPStarts/stops manual noninvasive blood pressure measurementStarts auto seriesStops current automatic measurement within seriesStart NBPStarts manual noninvasive blood pressure measurementStarts auto seriesStop NBPStops manual noninvasive blood pressure measurementStops current automatic measurement within seriesStop All NBPStops all noninvasive blood pressure measurementsRepeat NBPSets the time interval between two noninvasive blood pressure measurementsNBP ModesAccess NBP mode selection and setup, with direct start/stop functionEnter TempAllows the manual input of the patient's temperatureZero IUPResets the display and trace to 0. If you do not zero the IUP measurement properly, the pressure trace may exceed the paper scaling.TimerEnters NST timer windowStandbySwitches to standby screen, suspends monitoring. All numerics and waves disappear from the display. All settings and patient data information are retainedPatient Demogr.Enters the patient identification menu to admit/dischargeQuickAdmitQuick admits the patient for monitoringBlank KeyBlank key, can be used as divider between a group of keysSmartKey Name Function
3 Basic Operation44Pop-Up KeysPop-up keys are context-sensitive graphical keys that appear automatically on the monitor screen when required. For example, the Confirm pop-up key appears when you need to confirm a change.Using the TouchscreenSelect screen elements by pressing them directly on the monitor's screen.Disabling Touchscreen Operation1To temporarily disable the touchscreen operation of the monitor, press and hold the Main Screen permanent key for about three seconds. A red padlock will blink on the Main Screen permanent key.2Press and hold the Main Screen permanent key again for about three seconds to re-enable the touchscreen operation.Operating ModesWhen you switch on the monitor, it starts up in Monitoring Mode. To change to a different mode:1Select the Main Setup menu.2Select Operating Modes and select a mode.Your monitor has four operating modes. Some are passcode protected.Mode Description Password ProtectedMonitoring Mode The Monitoring Mode is the normal operating mode to monitor patients. You can change elements such as alarm limits. When you discharge the patient, these elements return to their default values.You cannot select or change grayed out items. These items are for your information only. To change these items, switch to the Configuration Mode.noDemo Mode The Demo Mode is used for demonstration and training purposes. Do not change into Demo Mode during monitoring. When transducers are connected to the monitor and the recorder is on, a demo trace is recorded. But the demo trace is not transmitted when the fetal monitor is connected via RS232 to an information and surveillance system such as OB TraceVue/IntelliSpace Perinatal.yes
3 Basic Operation45A field displayed at the fetal monitor screen indicates if the monitor is in Demonstration Mode, Configuration Mode, or Service Mode. To change to a different mode, select this field.Automatic Screen LayoutsYour monitor's preconfigured screen layouts define how measurement information is arranged on the screen. The monitor automatically applies the correct screen layout for the measurements you are monitoring. No user action is required.Connecting or disconnecting transducers, or activating or deactivating a cableless measurement, results in an automatic adjustment of the screen layout. When a measurement is off, its numerics are removed from the monitor's screen. The monitor stops acquiring data and generating alarms for this measurement. If you disconnect a transducer while it is performing a measurement, the monitor issues a disconnect INOP (and in the case of SpO2, replaces the measurement numeric with a question mark).SettingsThis section describes the various settings available on the monitor.Active SettingsWhat the monitor displays, and the way it operates, is controlled by its settings. They determine sound volume settings, recorder settings, high and low alarm limits and so forth.The "active settings" are the current settings the monitor uses, including any adjustments made by the last user. Active settings are not permanent, but are retained after a loss of mains power.There are also two preconfigured default settings:•User Default• Factory DefaultConfiguration Mode The Configuration Mode is for personnel trained in configuration tasks. You can change and store the default values and patient profiles permanently in the Configuration Mode. These tasks are described in the Configuration Guide. During installation, the fetal monitor is configured for use in your environment. This configuration defines the default settings you work with when you switch on the fetal monitor.yesService Mode The Service Mode is for trained and authorized service personnel only.yesMode Description Password Protected
3 Basic Operation46User DefaultThe User Defaults are a complete configuration stored in the monitor's long-term memory. You can store the active settings, modified to your preference, in the User Defaults (in Configuration Mode).In Monitoring Mode, you can load the User Defaults settings to return to your preferred settings:1Select the Defaults SmartKey.2Select Confirm in the dialog box to load the User Defaults.Factory DefaultThe Factory Defaults is a complete configuration predefined at the factory. You cannot modify it. In Configuration Mode, you can load the Factory Defaults as the active settings.CAUTIONThis resets all settings to factory defined values, but be aware that some values will differ from those with which the fetal monitor was originally shipped from the factory (recorder speed and paper scale type will need to be corrected, for instance). After loading the Factory Defaults, check the settings, and if necessary, change them to the settings you normally use.You can use the Factory Defaults as the basis for producing your User Defaults. See the Configuration Guide for details.Global SettingsGeneral monitor configuration settings are stored in the Global Settings. These include settings for line frequency, QRS type, and whether the monitor is automatically reset to the User Defaults after a power interruption of more than one minute. You can change the Global Settings in Configuration Mode.Changing Measurement SettingsEach measurement has a setup menu in which you can adjust all of its settings. You can enter a setup menu:1with the measurement numeric - select the measurement numeric on the screen to enter its setup menu. For example, to enter the Setup FHR1 menu, select the FHR1 (fetal heart rate 1) numeric.2with the Main Setup SmartKey - if you want to set up a measurement when the measurement is switched off, use the Main Setup SmartKey and select Measurements. Then select the measurement name from the pop-up list. With this SmartKey you can access any setup menu in the monitor.This guide always describes the entry method using the measurement's setup menu. You can use the method you prefer.
3 Basic Operation47Changing Monitor SettingsTo change monitor settings such as brightness, or touch tone volume:1Enter the Main Setup menu.2Select the setting you want to change, or select User Interface to enter a sub menu where you can change user interface settings.Adjusting the Screen Brightness1Enter the Main Setup menu.2Select User Interface.3Select Brightness.4Select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright. Optimum is suitable for most situations.Adjusting Audio VolumeHere you can adjust the audio volume for Alarm Volume, QRS Volume, and Timer Volume. To adjust an audio volume:1Enter the Main Setup menu.2Select User Interface.3Select Audio Volumes, then select one of the volume types, and select an audio level. 10 is the loudest and 1 is the quietest. Selecting zero switches the volume off.Setting the Date and TimeThe current date and time is displayed in its own element in the information line of the monitor screen.1Select the date and time screen element from the monitor's information line to enter the Date, Time menu.2Select, in turn, the Year, Month, Day, Hour (in 24 hour format), and Minute, as necessary.3Select Store Date, Time to change the date and time.WARNINGDo not change the date and time setting, if the fetal monitor is connected to a Philips OB TraceVue/IntelliSpace Perinatal system. The monitor uses the OB TraceVue/IntelliSpace Perinatal system date and time, including daylight saving time changes. As long as the fetal monitor is connected to the OB TraceVue/IntelliSpace Perinatal system via the LAN-setup (locomotive symbol displayed on the monitor's screen), the option to change the date and time settings at the fetal monitor are disabled, this is not valid for RS232 connections, or the connection to other systems.
3 Basic Operation48When disconnected from AC power, the monitor retains the date and time setting for at least two months. If the monitor is off longer than two months, and the operating system detects that the date and time settings are invalid, the monitor initiates a "cold" start and sets the date to 1 Jan 1997 and the time to 00:00.Checking Your Monitor Revision1Select Main Setup, Revisions to open the Monitor Revision menu.2From the Monitor Revision menu, select the monitor component for which you need revision information.Preparing to MonitorConfirm fetal life before you begin fetal monitoring. Familiarize yourself with the basic operation principles before you start to monitor.CAUTIONCheck the fetal monitors housing for damage before you start to monitor as part of your safety precautions.After you switch on the monitor:1Check that you have the correct patient cables and transducers plugged in for the measurement you want to monitor.2If you use an Avalon CL or Avalon CTS system, check if the cableless transducers are ready and charged (apparent by either a lit up green or yellow LED indicator).3Admit your patient to the monitor (see “Admitting a Patient” on page 147).4Check that the alarm limits, alarm and fetal heart rate volumes, patient category, and so forth, are appropriate for your patient. Change the settings if necessary.5Refer to the appropriate measurement section for details of how to perform the measurements you require.6Start recording.There is no special emergency access for the Avalon Fetal monitors. For all clinical use cases according the Intended Use, the monitors are taken into operation by connecting them to AC mains and by switching them on.Switching On: FM20/FM301Connect the monitor to AC mains and switch the monitor on.– The green power-on LED lights up.– The monitor performs a self-test as it starts up. Selftest: OK, the serial number, and revisions for the software and firmware are printed on the fetal trace paper (if recorder Auto Start is configured to On).– The monitor display comes on.– There is a start-up tone from the loudspeaker.BatteryOption • If this option has been chosen, the green power-on LED on both the external power supply and the battery LED indicator will light up.
3 Basic Operation49Switching On: FM40/FM501Connect the monitor to AC mains.– The green LED lights up.2Press the On/Standby switch.– The monitor performs a self-test as it starts up. Selftest: OK, the serial number, and revisions for the software and firmware are printed on the fetal trace paper (if recorder Auto Start is configured to On).– The monitor display comes on.– There is a start-up tone from the loudspeaker.Adjusting the Display Angle (FM20/FM30)You can tilt the display on the FM20 and FM30 to one of five different positions, or you can fold it completely down. The tilt/fold mechanism works on a one-way ratchet system. You hear a click as each of the five positions is reached. The screen can be folded back down only after tilting the display forwards as far as it will go.To tilt the display from the folded position:1Unlock the display by releasing the catch.2Lift the display forward. You will hear a click as the first position engages. If you want to tilt the display further, lift the display further forward until you reach the desired angle.
3 Basic Operation503To fold the display, pull the display forwards as far as it will go.4Then push the display all the way back until it clicks shut.If your monitor is wall-mounted, the display should be folded flat.Fastening Belts and TransducersYou can use more than one belt if, for example, you are monitoring uterine activity and FHR simultaneously. There are two basic ways to fasten belts and transducers:• Belts with button fixings.• Velcro belts together with the butterfly belt clip.What You Need• Ultrasound transducer• Toco MP or CL Toco+ MP transducer• Ultrasound gel• Transducer belt (and optional butterfly belt clip, if applicable)
3 Basic Operation51Using Belts with Button Fixings1Place the transducer belt across the bed, so that the fixing button will face away from the mother when it is fastened.2Lie the patient on the bed and arrange the belt around her until it is tight but still comfortable.3Fasten the belt by pushing the fixing button through the overlapping section of the belt. Ensure that the fixing button and the loose ends of the belt are at the patient's side.4When you have positioned a transducer satisfactorily, you can attach it to the belt by pushing the belt button on the transducer through one of the holes in the belt.
3 Basic Operation525Alternatively, attach the butterfly belt clip to the transducer belt button and use this to attach the transducer to the belt. The clip allows you to slide the transducer for easy repositioning.Using Belt with Velcro FixingsInsert one end of the belt between the belt guides on one side of the butterfly belt clip, and secure with the velcro fixing. Insert the other end of the belt between the belt guides on the other side of the butterfly belt clip, adjust for the correct tension, then secure with the velcro fixing.WARNINGWhen connecting devices for acquiring measurements, always position cables and NBP tubing carefully to avoid entanglement or potential strangulation.1Velcro fixing2Belt guides3Velcro fixing
3 Basic Operation53Repositioning TransducersA patient possibly wears transducers for long periods without interruption. In rare cases, skin irritations may occur if a transducer is attached to one location for a longer period. To ensure there are no adverse effects on the patient's skin, inspect the transducer application site at least every three hours. If the skin quality changes, move the transducer to another site.The ultrasound transducer is often repositioned to follow the fetal heart as part of the normal monitoring process, but this is not so for the Toco transducer. Therefore, remember to check its application site (between contractions) at least every three hours.To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to remain on the transducer. Follow all instructions that accompany the specific cleaning and disinfecting agents you are using. Remove agent residues with a cloth dampened in water before applying a transducer to a patient.See “Care and Cleaning” on page 261 for further information, and a list of approved agents.Connecting a Transducer to the Monitor1SpO2 socket2Noninvasive blood pressure socket3Fetal sensor socketsYou can plug a fetal transducer, an ECG/IUP patient module, an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (red connector), or an external event marker into any of the four fetal sensor sockets marked by the fetal symbol, or "Fetal Sensors" (depending on geography). For measuring maternal SpO2, connect the sensor to the socket marked with the SpO2 symbol or "SpO2" (depending on geography).For maternal noninvasive blood pressure, connect the cuff to the socket marked with the NBP symbol or "NBP" (depending on geography).
3 Basic Operation54For the FM20 and FM30, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer system interface cable (red connector) to one of the fetal sensor sockets at the left side of the monitor.For the FM40 and FM50, you can connect an Avalon CL or Avalon CTS Cableless Fetal Transducer System interface cable (black connector) to one of the two dedicated black sockets marked "Tele" at the rear of the monitor, as an alternative to using one of the fetal sensor sockets (red connector) at the front.What You See on the MonitorWhen you connect a transducer or sensor, the measurement numeric appears on the screen.Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, when monitoring triplets, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second FHR2, and the third FHR3. See also chapters “Monitoring Twin FHRs” on page 183 and “Monitoring Triple FHRs” on page 191.When you touch a measurement numeric on the screen, the setup menu for that measurement opens. The fetal sensor socket to which the transducer for this measurement is connected is identified by the transducer position indicator in the setup menu header.1Interface cable to Avalon CL and Avalon CTS Cableless Fetal Transducer System.2Connect the black connector to one of the two black sockets (marked "Tele") on the rear of the monitor.FM20/FM30 FM40/FM50
3 Basic Operation55The blue finder LED on a wired fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer.The white finder LED on a cableless fetal transducer lights up when you touch the measurement on the screen, allowing you to identify the corresponding transducer.The recorder prints an annotation showing the date, time, recorder speed, and Monitoring Mode. It repeats this every 10 minutes.Start RecordingChecking/Setting Paper ScaleYou can check the paper Scale Type (US for USA, or Internat'l for other geographies) in the Fetal Recorder menu. In Monitoring Mode, you can see these settings (grayed out), but you cannot change them. They can be changed in Configuration Mode, see the Configuration Guide.NOTECheck if the scale type of the paper and the settings in the fetal monitor match.1finder LED1finder LED cableless transducer
3 Basic Operation56Paper Guide FM40/FM50The recorder in the FM40 and FM50 features a transparent paper guide which:• facilitates correct alignment of the paper, both during loading and while the recorder is running. See “Loading Paper FM40/FM50” on page 65.• incorporates a tear-off edge, which not only allows you to tear off the trace paper where you like (not necessarily at a fold), but also helps to avoid paper misalignment while doing so (see “Tearing Off the Paper” on page 61).• is removable (see “Removing the Paper Guide: FM40/FM50” on page 269).Switching the Recorder On and OffIn addition to the normal recording of real-time traces, you will sometimes see a trace recovery printout from the monitor's internal backup memory at high speed when the recorder is started. For details, see “Recovering Traces on Paper” on page 257.For an explanation of the various symbols that can appear on the trace recording, see “Recorder Specifications” on page 308.To switch the recorder on, select in Main Setup the menu item Fetal Recorder, or press one of the SmartKeys: Start/ Stop or Start Recordng.The "recorder on" status indicator is displayed in the bottom right-hand corner of the screen when you switch on the recorder.The paper advances quickly for 2 cm and then returns to the set speed. Whenever the recorder is switched on, a trace header is printed vertically on the trace paper, containing the following:•Selftest: OK: confirmation that the monitor's self-test completed successfully, and that it is ready to use• the software revision and firmware revision• the serial number• the time• the date• patient name and medical record number (if entered)• the recorder speed
3 Basic Operation57The current monitoring modes (if any transducers are connected to the monitor) are printed. Whenever a transducer's mode is changed, the following are printed:• the time• the date• trace identification symbols• the recorder speedThe monitor prints the time, date, recorder speed, and monitoring modes in the trace header when first switched on, in a periodic time stamp every ten minutes after, and if the monitoring modes change. The time stamp begins with the symbol shown below. The data is reprinted in the header if the time and date are locally adjusted, or if an obstetrical information and surveillance system is connected that readjusts the time and date automatically.1Fetal heart rate label2Uterine activity label
3 Basic Operation58The trace records maternal parameters also. When measuring noninvasive blood pressure, the annotation is made at the end of the measurement. If the noninvasive blood pressure measurement repetition time is short, the noninvasive blood pressure numeric may not always be printed.The recording of notes (see “Entering Notes” on page 69) or time/date information may be interrupted by connecting, or unplugging a transducer, or by a change in measurement-related setting (for example, artifact suppression, Toco sensitivity, or alarm settings).A new patient admission or a change to the paper scale setting stops all annotations, and prompts a new vertical trace header to be printed.To switch off the recorder:1Either select Start/Stop from the Fetal Recorder menu.2Or press one of the SmartKeys (depending on configuration): fetal recorder Start/ Stop or Stop Recordng.If your recorder is configured with Confirmed Stop on (a Configuration Mode setting), you will need to confirm that you want to stop the recorder, before it will stop.When the recorder is off, the "recorder off" status indicator is displayed in the bottom right-hand corner of the screen: When the Paper Save Mode is set to Off the paper symbol shows an x mark, and when Paper Save Mode is On the icon shows a paper trace icon.1Time stamp printed every ten minutes
3 Basic Operation59Recording ElementsA variety of information can appear on the recorder trace. Here is a sample trace with some of the most common elements and their meaning. Each trace header contains the last name and first name, the patient ID, patient date of birth, the current date and time, patient's bed label, and the gestational age of the pregnancy.1Name, patient ID, date of birth, current date and time2Recorder speed3Gestational age and patient bed label4FMP - Fetal Movement Profile5Other measurements for the patient such as temperature, arterial oxygen saturation, and pulse6Entered notes such as patient repositioned, or MD notified, or others7Time stamp8Trace separation9Recorder speed10 Maternal ECG11 Direct ECG12 Coincidence of heart rate detected13 HR with Alarms Off symbol14 Alarm Limits15 dFHR2 (second fetal heart rate from DECG)16 FHR1 (first fetal heart rate)
3 Basic Operation60CautionThe trace contains sensitive personal data. For information how to protect personal information, see “Protecting Personal Information” on page 17.Choosing Recorder SpeedYou can choose a recorder speed of 1, 2, or 3 centimeters per minute (cm/min). The default setting is 3 cm/min.The ACOG technical bulletin on FHR monitoring states that "accurate pattern recognition is difficult if not impossible at 1 cm/min and that 1 cm/min is only recommended for more economic screening. When FHR abnormalities arise, the faster recorder speeds will enhance FHR pattern recognition".Additionally, because a change in recorder speed results in a change in the appearance of an FHR trace, you are advised to ensure ALL monitors in your institution are set to the same speed.To set the recorder speed (in Configuration Mode), see the Configuration Guide.Advancing the PaperYou can advance the paper automatically to the next fold by pressing the Paper Advance SmartKey at any time except during a stored data recording. This is also possible using the Fetal Recorder menu.Marking an EventYou can record significant events on the trace paper (for example, when pain medication is administered or when the mother changes position). The mother can use the remote event marker to mark events herself. You connect the remote event marker to any free fetal sensor socket.To mark an event on the trace paper, you can:1Either select the Set Marker SmartKey.2Or press the button on the optional remote event marker (989803143411). The remote event marker is connected to the monitor via any fetal transducer socket.
3 Basic Operation61A small arrow is printed on the heart rate scale on the trace paper.This reflects exactly when the marker button was first pressed; keeping the button pressed has no influence on the annotation.Tearing Off the PaperCAUTIONNever pull on the paper to advance it, as this can cause misalignment of the paper. Always tear off the paper along the perforation.FM40/FM50 The recorder's paper guide incorporates a tear-off edge, allowing you to tear off the trace paper cleanly where you like (not necessarily at a fold). When you are not using the paper guide, always tear off the paper along the perforation.To tear off the trace paper after monitoring using the paper guide:1If the recorder is running (the "recorder on" status indicator is displayed), turn off the recorder by selecting the fetal recorder Start/ Stop SmartKey or the Stop Recordng SmartKey.2Tear off the paper as shown in the picture. To ensure a clean tear, always tear in an upwards motion, as indicated by the arrows. You can start tearing from the left or right (right-handed user
3 Basic Operation62shown). You may want to use both hands to guarantee that the paper is not misaligned during the tear off.3If you wish to tear off the paper at a fold, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off.FM20/FM30 The FM20/FM30 does not have a paper guide. The procedure is the same as described for the FM40/FM50 with the exception that you should advance the paper to a perforation.If you wish to tear off the paper at a perforation, select the Paper Advance SmartKey, wait for the paper to stop, then tear it off.Paper-Out IndicationEach pack of paper has 150 pages. The monitor issues a paper-out warning in the status line at the bottom of the screen, when there are five pages to go. If you switch on the recorder or press the Paper Advance key when there are fewer than five pages remaining, it may take two pages before the alarm is activated. Load a new pack in time.If the recorder runs out of paper, an audible paper-out alarm is sounded, if so configured. See “Loading Paper FM40/FM50” on page 65, and “Loading Paper FM20/FM30” on page 62 to learn how to reload paper.Fetal traces continue to be recorded into the monitor's backup memory, and can be retrieved and printed completely if new paper is loaded within one hour, when the Bridge Paperout setting is enabled in Configuration Mode. See “Recovering Traces on Paper” on page 257 for further information.Loading Paper FM20/FM30CAUTIONUsing recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty.
3 Basic Operation63FM20/FM30 To load a pack of paper:1If the recorder is on, press the recorder Start/ Stop SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper.2Press the paper table release to unlock the paper drawer and then pull the table forward to open it fully.3Lift out any remaining paper from the tray.4Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is indicated by the word STOP printed on the final page of the new pack.
3 Basic Operation645Unfold the top page of the pack and position the uterine activity scale on the right.6Slide the pack into the tray.
3 Basic Operation657Push the paper drawer back until it "clicks" closed.8Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder.Annotations of trace information are printed on the trace paper (see “Switching the Recorder On and Off” on page 56 for details).Loading Paper FM40/FM50CAUTIONUsing recorder paper that is not approved by Philips can result in accelerated paper fading and can damage the thermal line printhead. This type of damage is not covered by warranty.FM40/FM50 To load a pack of paper:1If the recorder is on, press the Start/ Stop Rec SmartKey or the Stop Recordng SmartKey to turn it off before loading a new pack of paper.2Press the paper eject button to open the paper drawer.
3 Basic Operation663Lift out any remaining paper from the tray.4Press and hold the paper eject button to partially eject the paper, thus making it easier to remove.5Hinge the transparent paper guide forward. It is held in the closed position by a small protrusion on each side of the holder.A - Protrusion holds paper guide in closed position.
3 Basic Operation676Prepare to place the new pack of paper in the tray with the bottom side down. The bottom side is indicated by the word STOP printed on the final page of the new pack.7Unfold the top page of the pack and position the uterine activity scale on the right.8Slide the pack into the tray.9Feed the paper evenly through the paper guide. Do not close the paper guide yet.
3 Basic Operation6810 Close the paper drawer.11 Now close the paper guide.12 Press the recorder Start/ Stop SmartKey or the Start Recordng SmartKey to switch on the recorder.Annotations of trace information are printed on the trace paper (see “Switching the Recorder On and Off” on page 56 for details).
3 Basic Operation69Entering NotesYour monitor has a set of 15 factory pre-configured notes (see below). It is possible to edit these notes in Configuration Mode (see the Configuration Guide). The maximum length of one single note is 30 characters.To enter a note:1Select the Enter Notes SmartKey to open the Enter Note menu.2Scroll if necessary, then select the note you wish to enter. A confirmation dialog box opens:3Select Confirm to enter the note. The note is then shown in the status line of the display, and is annotated on the fetal trace if the fetal recorder is on.4By default, notes are printed lengthwise in the direction of the trace, in the space between the FHR grid and the uterine activity grid. If you prefer, you can configure the recorder to print across the trace. You can change this in Configuration Mode.The following are the pre-configured notes from which to choose:1Patient Repositioned2Vaginal Examination3MD Notified4Sitting5On Back6Left Lateral7Ambulating8Tocolytic Given9Membranes Ruptured10Amniotomy11Amniotic Fluid Clear12Amniotic Fluid Not Clear13Oxytocin14Urinary Catheter15Micro Blood AnalysisUp to two notes can be printed directly, and the monitor can temporarily store up to a further two notes, and these are printed after the first two have been printed. Any further notes are discarded. For example, if you enter six notes in quick succession, the first two notes you entered are printed right away, the next two are stored in memory and then printed when the first two have been printed, and the last two are discarded.If the printing of two notes happens to coincide with the regular printing of the time stamp that takes place once every ten minutes, the time stamp is delayed until the notes have finished printing.
3 Basic Operation70Typing NotesOther than the pre-configured notes selectable in the Enter Note menu, a note can be typed in manually.To type a note:1Select the Enter Notes SmartKey to open the Enter Note menu.2Select Type a note and a window with a touch keypad opens.3Type the note and select Enter. The typed note can be up to 30 characters long. The note is shown in the status line of the display, and is annotated on the fetal trace if the fetal recorder is on.NOTEThe typed note remains in the window until it is deleted by using the backspace button of the keyboard.Signal QualityDuring monitoring, if the fetal heart rate signal quality fluctuates, and becomes poor, it does not necessarily mean that the transducer needs repositioning. The fluctuation may be caused by fetal movement. Allow time for the signal to stabilize before deciding whether to reposition the transducer (ultrasound), or apply a new electrode (ECG). For the best trace quality, the signal quality indicator should be full, indicating good signal quality, even though it may be possible to make traces at a lower signal quality level.After MonitoringWired and cableless transducers1Discharge the patient.2Remove the transducer from the patient and, using a soft tissue, remove any gel from it. Then clean the transducers.3Dock CL transducers to the base station so they can recharge.4Tear off the paper at the fold. To avoid misalignment of the recorder mechanism, NEVER pull on the paper to advance it, or try to tear it other than at a fold (unless using the paper guide with the FM40/FM50).5Switch off the monitor.NOTEIf an Avalon CL base station is connected to your FM20/30 monitor, do not turn off the monitor if you need to recharge the batteries of the CL transducers. They can only be recharged if the FM20/30 monitor is on. If an Avalon CL base station is connected to an FM40/50 at the Telemetry ports in the rear, the batteries of the CL transducers can be recharged while the monitor is not switched on. If you disconnect a base station from a fetal monitor when the CL transducers are not fully charged, the base station starts beeping. If you want to still disconnect it, confirm your choice by pressing the Standby key of the base station, and the beeping stops.
3 Basic Operation71Switching the Monitor to the Standby ScreenTo switch the monitor to the Standby screen:Either1Select the Monitor Standby SmartKey.Or1Enter the Main Setup menu using the SmartKey.2Select Monitor Standby.3Pressing any key or selecting any field on the screen will resume monitoring.Disconnecting from PowerFM20/30To disconnect the monitor from AC power, switch the monitor off using the On/Off switch located on the right side of the device, or unplug the power cord from the AC mains socket.FM20/FM30 with Battery Option and FM40/FM50The On/Standby button does not disconnect the monitor from the AC power source. To disconnect, unplug the power cord from the AC mains socket. Note that if the power cord is unplugged from the AC mains socket before the monitor is put into Standby, a beeper is activated. The beeper warns you if the monitor is accidentally disconnected from AC mains.External Power Supply for the Avalon CL Base StationTo disconnect, unplug the power supply from the AC mains socket. Note that if the power supply is unplugged from the AC mains socket before all CL devices are fully charged, a beep is issued. To confirm the disconnection from power, and to silence the beep, press the On/Standby button of the CL base station.Power On/Power Off BehaviorThe general rules determining the behavior of the fetal monitors when connected to, or disconnected from power are as follows:• A fetal monitor that was switched on prior to a temporary power loss, switches on again when power is restored.• A fetal monitor that was switched off prior to a temporary power loss, remains off when power is restored.• When AC mains power is lost, a battery powered monitor (FM20/30) continues to run without interruption on battery power.
3 Basic Operation72Monitoring After a Power Failure• A fetal monitor that was switched on prior to a temporary power loss, switches on again when power is restored.• A fetal monitor that was switched off prior to a temporary power loss, remains off when power is restored.• If the fetal monitor is without power for less than one minute, monitoring will resume with all active settings unchanged.• If the fetal monitor is without power for more than one minute, the behavior depends on your configuration.–If Automat. Default is set to Yes, the default profile will be loaded when power is restored.–If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration Mode.TroubleshootingProblem Possible Causes SolutionsLight or no trace Wrong paper Use recommended paperDirty printhead Clean printhead, see “Cleaning the Print Head” on page 273FM20/30 only: Paper misaligned due to drawer not being correctly shutShut the drawer fully, pushing evenly with both handsEnd of paper noted when pack not finishedBad paper feed or wrong paper Check paper feed and use recommended paperCheck Paper INOP is displayed INOP messages always indicate equipment problemsSee “Patient Alarms and INOPs” on page 129FetRec Equip Malf INOP is displayedPaper End INOP is displayedWrong Paper Scale INOP is displayed
4734Cableless MonitoringAvalon CL Transducer SystemThe Avalon CL Fetal Transducer System lets you monitor the patient continuously with cableless transducers during the antepartum period, labor, and delivery.You can monitor the fetal heart rate (FHR):• Using noninvasive CL Ultrasound transducers• Invasively, using the CL ECG/IUP transducer or CL Toco+ MP transducer with a fetal scalp electrode• Noninvasively, with the CL F&M PodThe uterine activity can be monitored using:• Externally, using the CL Toco+MP transducer• Externally, using the CL F&M Pod• Invasively, using the CL ECG/IUP transducer or CL Toco+MP with an IUP catheterThe fetal and maternal parameters are measured and transmitted via radio frequency from the CL transducers and CL Pods to the CL base station, eliminating the need for patient cables. With the Avalon CL Transducer System, you can monitor a single fetus, twins, and triplets.The Avalon fetal monitor (FM20-FM50) connected to the CL base station displays and records the parameters. All the CL transducers and the CL F&M Pod are watertight. The IntelliVue CL Pods should not be immersed in water. You can continuously monitor patients in a bath or shower using the CL Toco+MP and the CL Ultrasound transducers, the CL F&M Pod should not be used during a bath.
4 Cableless Monitoring74Basics of Cableless SystemsAssigning Cableless DevicesThe cableless devices of the Avalon CL are assigned by simply docking them at the base station connected to the patient’s fetal monitor. See the Avalon CTS Instructions for Use for the assignment of the CTS transducers.Activating Cableless DevicesThe CL devices of the Avalon CL are activated by picking them up from the base station. If the CL devices are activated, a corresponding symbol is displayed on the fetal monitor screen next to the numeric of the measurement. See the Avalon CTS Instructions for Use for the activation of the CTS transducers.Deactivating Cableless DevicesThe CL devices of the Avalon CL are deactivated by redocking them at a base station. To deactivate all cableless devices at once, press the Standby key of the Avalon CL base station. See the Avalon CTS Instructions for Use for the deactivation of the CTS transducers.Unassigning Cableless DevicesThe CL devices of the Avalon CL are unassigned by manually removing them in the corresponding setup menu from the group of assigned cableless devices, or by unassigning them directly in the Tele Info window. See the Avalon CTS Instructions for Use for the unassignment of the CTS transducers.Avalon CL Transducer System Avalon CTS Transducer System
4 Cableless Monitoring75Twins and Triplets SupportConfiguration of Cableless SystemsYou have to configure the radio channels of the Avalon CL and Avalon CTS transducer system for communication to work, and not to interfere with any other telemetry devices.The configuration of a connected Avalon CL system is done in Configuration Mode or Service Mode of the fetal monitor. Service Mode functions can be used to identify channel assignment conflicts in the hospital environment. The configuration should be carried out by authorized and qualified service personnel, either by the hospital's biomedical department, or by Philips Support.For a detailed description of the configuration see the Avalon CL Service Guide and the Fetal Monitor Configuration Guide. For details regarding the configuration of a connected Avalon CTS system see the Avalon CTS Service Guide.Fetal Movement ProfileWhen using an Avalon CL or Avalon CTS you should be aware that monitoring FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the fetal monitor (Fetal Movement Off) if the mother is walking. Maternal movements are likely to create artifact in the FMP output. See also “Switching FMP On and Off” on page 171, the sections “Cableless Monitoring - Important Considerations” on page 167, and “Fetal Movement Profile” on page 170.Twins and Triplets Singletons onlyAvalon CL Transducer System and CL transducersAvalon CTS SystemAvalon CL Transducer System with CL Fetal & Maternal Pod
4 Cableless Monitoring76Getting to Know Your Avalon CLFront1Transducer docking slots2On/Standby button with LED3Device label4LED for optional cableless Pods5Docking slot for cableless PodsWARNING• To avoid magnetic interference affecting the mode of the pacemaker, ensure that the Avalon CL base station does not come into close contact with implanted pacemakers.• This equipment generates, uses, and radiates radio-frequency energy, and if it is not installed and used in accordance with its accompanying documentation, may cause interference to radio communications. Operation of this equipment in a residential area may cause interference, in which case you must take whatever measures may be required to correct the interference.
4 Cableless Monitoring77Docking Slots for Cableless TransducersThe Avalon CL base station has three docking slots to hold the CL transducers. The transducers are charged while docked. The base station has a built-in radio interface with an integrated antenna to communicate with the transducers.On/Standby ButtonPressing the On/Standby button switches the Avalon CL base station between the two modes On and Standby.If you switch the base station to On, the LED button lights up green. The base station is ready for use. When the transducers are picked up from their docking slot, the base station sets up the radio communication to the CL transducer automatically. Wired transducers connected to the fetal monitor are disabled, and the antenna symbol for the CL transducer is displayed on the screen of the fetal monitor.If you switch the base station to Standby, the LED button turns off. The base station is now in Standby mode. No radio communication occurs, any existing radio communication is stopped.If the LED of the On/Standby button turns red, it indicates a technical problem has occurred that needs your attention. Check your monitor for a possible related INOP message.1On/Standby button
4 Cableless Monitoring78Docking Slot for Cableless Measurement PodsThe Avalon CL base station has one docking slot to hold a CL F&M Pod or an IntelliVue CL Pod. The CL Pod is charged while docked. The LED under the docking slot indicates the battery status of the CL Pod. The base station has a built-in short range radio interface with an integrated antenna to communicate with the CL Pod.WARNINGShort range radio connections are subject to interruption due to interference from other radio sources in the vicinity, including microwaves, bluetooth devices, WLAN devices (802.11b,g,n), and cordless phones. Depending on the strength and duration of the interference, the interruption may occur for an extended period. A loss of connection, due to moving out-of-range, interference, or for other reasons, is indicated with a No Host Monitoring INOP (here the host is the fetal monitor) on the NBP or SpO2 Pods, or a cl NBP Disconnect or cl SpO Disconnect INOP at the fetal monitor. Correct channel configuration is important, see the Configuration Guide for details.Audio Signal CL Base StationThe Avalon CL base station has two audio signals:• If the base station issues a descending tone sequence, the attempt to set up radio communication to a CL transducer or CL Pod has failed.• The base station issues a permanent beeping tone if it is disconnected from a fetal monitor, or if the FM20 or FM30 monitor is switched off, and the base station has transducers or a Pod currently docked that need to be recharged.Alarming is only available at the Avalon Fetal Monitor, not at the Cableless Measurement Devices, see the Instructions of Use for the IntelliVue Cableless Measurements.1Docking slot for CL Pods
4 Cableless Monitoring79Rear and Bottom1Name plate1Manufacturer label2Cable reel
4 Cableless Monitoring80Connection OptionsThe fetal monitors FM20/FM30 and FM40/FM50 are compatible with the Avalon CL and Avalon CTS Transducer Systems. Regard the following points for cableless monitoring:• You can connect one Avalon CL base station with a red connector to an FM20/FM30 or an FM40/FM50 (fetal socket), or one Avalon CL base station with a black connector to an FM40/FM50 (telemetry socket).• You can connect two Avalon CL base stations with black connectors to an FM40/FM50 (telemetry sockets)
4 Cableless Monitoring81•You cannot connect two Avalon CL base stations to an FM40/FM50, if one Avalon CL base station has a red connector, and the other Avalon CL base station has a black connector.• You can connect one Avalon CTS system to an FM20/FM30 or FM40/FM50 at a time (either fetal or telemetry socket).
4 Cableless Monitoring82•You cannot connect an Avalon CTS and an Avalon CL at the same time to the same fetal monitor.• Monitoring a multiple pregnancy using cableless transducers is supported by the Avalon CL system only.• Using a mixture of wired and cableless fetal transducers is not supported. You can use either wired or cableless fetal transducers.• If you cannot get sufficient signal quality using Avalon CTS transducers, switch to wired transducers.
4 Cableless Monitoring83Connecting Two CL Base Stations to an FM40/50 MonitorTwo base stations can be connected to an FM 40/50 fetal monitor at the rear black telemetry ports. At both base stations CL transducers and CL Pods can be assigned, activated, and redocked for charging. The base stations work as one extended system together. Pressing the Standby key of either base station, puts both base stations in Standby mode. The Tele Info window shows both base stations in operation.External Power Supply (Option K60)In combination with the optional external AC power supply an Avalon CL base station serves only as a charging station for Avalon CL transducers and IntelliVue CL Pods, and all radio communications are disabled. The On/Standby button of the base station lights up white in this operation mode. The charging indication of the LEDs of the docked CL transducers and the IntelliVue CL Pods remain the same as described in the sections “Cableless Transducer LED Indication” on page 86 and “Battery Status LED for CL Pods” on page 93.When a transducer is picked up from the base station after charging, it needs to be activated for monitoring by docking it on a CL base station connected to the patient's fetal monitor.
4 Cableless Monitoring84Cableless TransducersThe cableless Avalon CL transducers have a built-in radio interface with an on-board, integrated antenna. The fetal monitor connected to the Avalon CL base station can control the transducer using radio communication. The CL transducer transmits measured values, alarms, and status information to the fetal monitor.The CL transducers are assigned by simply docking them at the Avalon CL base station. If they are picked up from their docking slot at the base station, they are automatically activated.CAUTIONTo ensure the correct assignment of CL transducers to the fetal monitor in use, always dock them at the base station connected to that fetal monitor before use. This is particularly important when you add an additional CL transducer that was previously docked at another base station.NOTEAvoid dropping the transducers.1Transducer finder LED - lights up on the transducer providing the measurement source.2CL Toco+ MP transducers (capable of providing the maternal pulse measurement)3Belt buttonCL Ultrasound transducer
4 Cableless Monitoring85Connector Cap for the CL Toco+ MP TransducerThe CL Toco+ MP transducer is delivered with a connector cap covering the MECG/DECG/IUP connector. The connector cap is designed to cover the connector, not to protect it from water. (The connector itself is water-proof and may be immersed in water).CL ECG/IUP transducer
4 Cableless Monitoring86Cableless Transducer LED IndicationThe cableless transducers have a multi-color LED that indicates the status of the transducer with specific colors. This LED remains visible when the transducer is correctly attached to the transducer belt (Philips standard belt).1LEDLED Status MeaningWhite The LED lights up to identify the transducer among other transducers, and to easily verify the correct transducer assignment (transducer finder). The transducer finder LED is controlled by the fetal monitor. Press the numerics to identify the corresponding transducer.The LED also lights up when the mother is paged with the Call Patient SmartKey.White one short blink The LED shortly lights up to indicate that the transducer successfully opened a radio communication with the base station and that it is ready to use.Green The LED lights up green when the transducer is fully charged and docked at the base station.Yellow The LED lights up yellow when the transducer is charging and docked at the base station.Red The LED flashes red when the transducer is out of battery and has to be recharged.When a docked transducer performs an update, the LED will blink fast red for about 1 minute. In this case, do not remove the transducer until the LED lights up green or yellow again.Cyan The LED lights up cyan to indicate a technical problem that needs your attention. Check your fetal monitor for a related INOP.
4 Cableless Monitoring87Audio Signal CL TransducersThe Avalon CL transducers have three audio signals:• If an ascending tone sequence is played three times, the transducer was triggered by the fetal monitor to page the patient wearing it, or to locate a not docked transducer.• If the CL transducer's battery is empty, the transducer issues three beeps in intervals.• An INOP tone indicates that the transducer has detected a technical problem (INOP). Check your fetal monitor for a related INOP message.Standard Radio Range of CL TransducersThe CL transducers have an operating range around the base station of at least 100 m/300 ft in the line of sight. Obstructions such as walls, metal doors, elevators, and other environment structures can lead to signal loss. The CL symbol indicator and the Tele Info window on the monitor's display (see “Screen Elements” on page 39 and “Tele Info Window” on page 94) provide information on the status of the signal strength.When a patient is approaching the end of range, the US sound is replaced by an artificial QRS sound (like DECG), and the DECG and MECG waves are no longer displayed on the monitor.Out of RangeIf the patient walks out-of-range, the CL transducer LED lights up cyan and every 16 seconds a two-tone audio signal is emitted. At the monitor the INOP e.g. cl US Disconnect is issued. Inform the patient to return to the CL base station, when a CL transducer starts beeping.Radiated Transmission PowerThe Avalon CL transducers provide all the benefits and flexibility of cableless operation, but do so with an effective radiated transmission power significantly less than that of a typical remote controlled child’s toy or mobile phone.Extended Range RadioUsing the optional CL Wide Range Pod extends the radio range of the CL transducers and the CL Pods to the local WLAN infrastructure. If the CL Wide Range Pod is active, the US sound is replaced by an artificial QRS sound (like DECG), and the DECG and MECG waves are no longer displayed on the fetal monitor. Numerics, alarms, and traces are shown at the fetal monitor as usual. See also “CL Wide Range Pod” on page 91.
4 Cableless Monitoring88Using CL Transducers with a Belt ClipThe Avalon CL transducers can also be used with an optional belt clip to be ordered separately (989803184851).1Avalon CL belt clip
4 Cableless Monitoring89CL PodsCL Fetal & Maternal PodThe CL F&M Pod provides measurement values for FHR, Toco, and HR. It communicates them to the fetal monitor using short range radio (SRR). It is controlled via SRR from the Avalon CL base station and the connected fetal monitor.The CL F&M Pod is assigned by docking it at the Avalon CL base station. Before monitoring, the CL F&M Pod is mounted on a single-use electrode patch, and held in place by integrated magnets. When the CL F&M Pod is active, the wired transducers connected to the fetal monitor are disabled.WARNINGThe CL Fetal & Maternal Pod has been validated with a gestational age of >36 weeks with patients in labor. It is only intended for singleton pregnancies. If the measurement signals are not good or in any way suspicious, use other means of monitoring (CL transducers or wired transducers).CL F&M PodCL F&M Patch
4 Cableless Monitoring90CL Fetal & Maternal Pod LED IndicationThe CL F&M Pod has a multi-color LED that indicates the status of the CL F&M Pod with specific colors.Audio Signal CL Fetal & Maternal PodThe Avalon CL F&M Pod has three audio signals:• If an ascending tone sequence is played three times, the CL F&M Pod was triggered by the fetal monitor to page the patient wearing it, or to locate a not docked CL F&M Pod.• If three beeps are issued at intervals, the CL F&M Pod's battery is empty.• An INOP tone indicates that the CL F&M Pod has detected a technical problem (INOP). Check your fetal monitor for a related INOP message.1LEDLED Status MeaningWhite The LED lights up to identify the CL Pod, and to easily verify the correct assignment (finder). The finder LED is controlled by the fetal monitor. Select the numerics to identify the corresponding CL Pod.The LED also lights up when the mother is paged with the Call Patient SmartKey.White, one short blink The LED briefly lights up to indicate that the CL Pod successfully opened a radio communication with the base station and that it is ready to use.Green The LED lights up green when the CL Pod is fully charged and docked at the base station.Yellow The LED lights up yellow when the CL Pod is charging and docked at the base station.Red The LED flashes red when the CL Pod's battery is empty, and has to be recharged.Cyan The LED lights up cyan to indicate a technical problem that needs your attention. Check your fetal monitor for a related INOP.
4 Cableless Monitoring91CL Fetal & Maternal Electrode PatchThe single-use disposable adhesive electrode patch holds the CL F&M Pod at the intended application site on the abdomen of the patient. The electrode patch has five adhesive electrodes. The CL F&M Pod is held in place during monitoring with magnetic contacts, and a connector. The electrode patch and the CL F&M Pod can only be used together and within the Avalon Cableless Transducer System solution for monitoring.CAUTIONThe electrode patch is single-patient use only, do not reuse the electrode patch on another patient to avoid possible cross-infection.CL Wide Range PodThe Avalon CL Wide Range Pod is a battery-powered auxiliary network device that converts the SRR and OB radio technology of Avalon CL transducers and the CL Pods into WLAN technology. This allows data from the measurement devices to be transmitted to a fetal monitor while the patient is ambulating.The Avalon CL Wide Range Pod is a mobile device which can be worn by the patient or by an attending caregiver. The display on the CL Wide Range Pod shows only technical data that may be useful for troubleshooting system problems.CL Wide Range Pod
4 Cableless Monitoring92IntelliVue CL PodsThe two IntelliVue CL Pods provide measurement values for SpO2 and NBP on the built-in display, and communicate them to the fetal monitor using short range radio (SRR). They are controlled with SRR from the Avalon CL base station and the connected fetal monitor.The maternal measurement pods are assigned by docking them at the Avalon CL base station.The CL SpO2 Pod and the CL NBP Pod have an LCD display and three keys for basic operation e.g. to assign the device to a patient:For further details, see the IntelliVue Cableless Measurements Instructions for Use.CL NBP Pod CL SpO2 Pod1Integrated LCD display2Hardkeys3Measurement identifier
4 Cableless Monitoring93Battery Status LED for CL PodsThe CL Pods do not have their own battery status LED, but a small battery gauge on their display. On the Avalon CL base station, the battery status LED for the CL Pods is located directly under the docking slot.The battery status LED shows five different states:Audio Signal CL PodsThe CL Pods have audio signals to let you know when a battery has to be recharged. If a CL Pod's battery is empty, the CL Pod issues three beeps at intervals.Calling PatientsTo call a patient currently not near the fetal monitor and base station, select the SmartKey Call Patient at the fetal monitor. The base station will then select one transducer, or the CL F&M Pod if it is assigned and active, to emit the tone sequence to notify the patient. Inform the ambulating patient, if the cableless device is issuing any beeping sounds, to return to the room with the fetal monitor.1Battery status LED for CL PodsStatus MeaningGreen The docked CL Pod is fully charged.Yellow The docked CL Pod is charging.Yellow blinking The communication is established with the docked CL Pod.Cyan Indicates that the docked CL Pod or the charging slot has a technical problem that needs your attention. Check your fetal monitor for a related INOP message.Off The battery status LED is off, when no CL Pod is docked.
4 Cableless Monitoring94TelemetryTele Info WindowThe Tele Info window of the fetal monitors allows you to manage the Avalon CL or CTS system. Below is an exemplary view of the Tele Info window. Your window may differ depending on the status of the connected system.To open the Tele Info window, you can:1Configure a Tele Info SmartKey to open the window,2select the CL symbol on the main screen, or3select the Main Setup and then Tele Info.1CL transducer symbol assigned with the parameter labels2Cableless measurement symbol and equipment ID3Base station symbol with docking indication (the white slot indicates a charging transducer)4Key Remove5Key Find6Key Battery Report (in Service Mode)7CL symbol8Remaining battery time9Out of battery symbol10 Indication of radio signal quality
4 Cableless Monitoring95Cableless Status IndicationWhen the monitor recognizes a connected Avalon CL or Avalon CTS interface cable (red or black connector), it confirms the recognition with the following status indicators displayed in the lower right-hand corner of the screen:Avalon CTSAvalon CLIndicator DescriptionAvalon CTS interface cable is connected to the monitor, but the Avalon CTS base station is not connected to the interface cable, or it is disconnected from AC mains, or is in Standby mode.Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and cableless transducers are ready to use, but no cableless transducers are currently active (all are still docked at the base station).Avalon CTS interface cable is connected to the monitor, Avalon CTS base station is connected, powered on, and at least one cableless transducer is active and assigned.Indicator Avalon CLA base station is connected to the monitor, but the base station is in Standby mode.A base station is connected to the monitor, but the base station is in Standby mode. The CL Wide Range Pod is activated and trying to connect to the monitor.A base station is connected to the monitor, but the base station is in Standby mode. The CL Wide Range Pod is activated and connected to the monitor.A base station is connected to the monitor but no cableless transducers and no cableless Pods are currently active. All are still docked at the base station, or the base station holds no transducers.A base station is connected to the monitor but no cableless transducers and no cableless Pods (except the CL Wide Range Pod) are currently active. All are still docked at the base station, or the base station holds no transducers. The CL Wide Range Pod is activated and trying to connect to the monitor.A base station is connected to the monitor but no cableless transducers and no cableless Pods (except the CL Wide Range Pod) are currently active. All are still docked at the base station, or the base station holds no transducers. The CL Wide Range Pod is activated and connected to the monitor.A base station is connected to the monitor, it is on, and minimum one assigned cableless transducer or cableless Pod is active.
4 Cableless Monitoring96NOTEA CL transducer is considered still active, even if it has an INOP condition (e.g. cl US Disconnect), until it is either deactivated by docking it at the base station, or until it is manually removed from the Tele Info window.Pop-up KeysMessagesThe fetal monitor issues messages to certain user interactions. For example, if the CL SpO2 Pod is picked up from the base station to activate it, the monitor displays the message cl SpO Added and the equipment label of the CL Pod.A base station is connected to the monitor, it is on, and minimum one assigned cableless transducer or cableless Pod is active. The CL Wide Range Pod is activated and trying to connect to the monitor.A base station is connected to the monitor, it is on, and minimum one assigned cableless transducer or cableless Pod is active. The CL Wide Range Pod is activated and connected to the monitor.A CL transducer has moved away from the base station and is approaching the limit of the area of reach (min. 100 m/300 ft in line of sight). The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed.A CL transducer has moved away from the base station and is approaching the limit of the area of reach (ca. min. 100 m/300 ft in line of sight). The US sound is replaced by an artificial QRS sound (like DECG). The DECG and MECG waves are no longer displayed. The CL Wide Range Pod is activated and trying to connect to the monitor.Indicator Avalon CLPop-Up key FunctionRemoveSelecting the Remove key deactivates and unassigns the selected active transducer or CL Pod and removes it from the list. This key is disabled if no active device is selected.FindSelecting the Find key pages the selected active CL transducer. This key is disabled if no active device is selected.
4 Cableless Monitoring97Use Priority When Combining Cableless and Wired MeasurementsCL Transducers versus wired transducersCL transducers have priority over wired transducers. If an Avalon CL or Avalon CTS base station is connected to the fetal monitor, and both wired and CL transducers are connected to the monitor, all the wired transducers are disabled whenever one CL transducer is active. To switch back to using wired transducers, switch the base station to Standby mode, or redock all CL transducers at the base station, and continue monitoring with the wired transducers.CL NBP and CL SpO2 versus fetal monitor built-in NBP and SpO2 measurementsCL NBP and CL SpO2 have priority over the built-in NBP and SpO2 measurements. If a CL NBP or CL SpO2 Pod is activated, the corresponding built-in measurement of the fetal monitor is deactivated. To switch back to the built-in measurements, switch the base station to Standby mode, or redock the CL Pods at the base station.CL F&M Pod versus wired transducersThe CL F&M Pod has priority over wired transducers. If a CL F&M Pod is active, all the wired transducers are disabled. To switch back to using wired transducers, switch the base station to Standby mode, or redock the CL F&M Pod at the base station.About RF Signal QualityIf you cannot get sufficient ultrasound signal quality using the Avalon CTS base station, try repositioning the transducers, or switch to wired transducers.Using an Avalon CL base station you should get a better signal by reducing the distance between the CL transducer and the base station.Signal transmission can be disturbed if:• the patient is out of range of the receiving area.• there is interference from another, possibly stronger, RF signal (a broadcasting station, for instance).• the patient is near material that absorbs electromagnetic waves (for example, metal-reinforced concrete, elevator doors) or the base station is in an enclosed metal rack.
4 Cableless Monitoring98CL Transducer AssignmentThe CL transducers are assigned by simply docking them at the Avalon CL base station connected to the patient’s fetal monitor.Since twins and triplets can be monitored with the Avalon CL base station, it can be delivered with up to six CL transducers: one CL Toco+ MP, three CL US, and two CL ECG/IUP transducers. Up to four CL transducer can be assigned at one time to the Avalon CL base station. Four assigned CL transducers enable monitoring combinations such as 1 CL Toco+ MP transducer + 3 CL US transducers for monitoring triplets externally, or 1 CL Toco+ MP transducer + 2 CL US transducer + 1 CL ECG/IUP transducer for monitoring twins.Three CL transducers can be docked and charged at the Avalon CL base station at a time. If a fourth transducer should be assigned to the Avalon CL base station:1Remove first the three docked CL transducers from the base station and place them on the patient.2Then dock the remaining fourth transducer at the base station and wait until the LED of the fourth transducer signals that it has communication with the base station.3Place the fourth CL transducer on the patient and check on the fetal monitor in the Tele Info window if the base station and the monitor have communication with all four transducers, and if their numerics are displayed on the screen of the fetal monitor.CL Transducer UnassignmentThe cableless transducer needs to be unassigned:• before being used with another base station on another patient• to allow cleaning before docking it back onto the base station (e.g. to replace it with a fully charged transducer of the same type)There are three methods to do this:1Open the setup menu of the measurement e.g. FHR1 by selecting the numeric on the screen.2Select Remove from the open setup menu.3A confirmation window opens with the prompt Please Confirm and Device will be removed.4Select the Confirm pop-up key. A message confirms cl US has been removed.or1Open the Tele Info window.2Select the symbol of the cableless transducer you want to unassign, and select Remove from the pop-up menu.3A confirmation window opens with the prompt Please Confirm and Device will be removed.4Select Confirm the pop-up key. A message confirms cl US has been removed.or1Redock the CL transducer at the base station.2Switch the base station to stand-by.3Remove the CL transducer; it is now unassigned.
4 Cableless Monitoring99NOTEWhen a CL transducer is unassigned, all the measurements from this transducer are no longer monitored; e.g. if you unassign a CL Toco+MP transducer, the Toco measurement, maternal Pulse, or possibly also MECG or DECG are no longer monitored.CL Pod AssignmentThe CL Pods are assigned by simply docking them at the Avalon CL base station connected to the patient’s fetal monitor.CL Pod UnassignmentThe CL Pods have to be unassigned:• before assigning them to another base station or to another patient• to allow cleaning, before docking them back onto the base stationThere are three methods to do this:1Open the setup menu of the measurement e.g. by selecting the numeric on the screen.2Select Remove from the open setup menu.3A confirmation window opens with the prompt Confirm and Device will be removed.4Select the Confirm pop-up key. A message confirms <cl Measurement> has been removed.or1Open the Tele Info window.2Select the symbol of the CL Pod, and select Remove from the pop-up menu.3A confirmation window opens with the prompt Confirm and Device will be removed.4Select the Confirm pop-up key. A message confirms <cl Measurement> has been removed.or1Redock the CL Pod at the base station.2Switch the base station to stand-by.3Remove the CL Pod; it is now unassigned.To unassign a IntelliVue CL Pod using its user interface, see the Cableless Measurement Instructions for Use.NOTEIf you unassign a CL Pod, all the measurements from it are no longer monitored, or are monitored by a connected lesser prioritized sensor.
4 Cableless Monitoring100Preparing to Monitor CablelesslyWhen monitoring cablelessly with the FM20/30/40/40 monitors, most of the same procedures apply as described in “Preparing to Monitor” on page 48. Additions and deviations applying to cableless devices and existing procedures are described here.CL Transducers1To monitor cablelessly with the CL transducers, assign them at the base station as described in “CL Transducer Assignment” on page 98.2Place the CL transducers and the belt on the patient described in “Fastening Belts and Transducers” on page 50.3Check the measurements on the monitor, and if necessary, move the CL transducers until you have a good signal for all measurements.IntelliVue CL Pods1To monitor cablelessly with the IntelliVue CL Pods, assign them at the base station as described in “CL Pod Assignment” on page 99.2Put the CL Pods in their cradles and place them on the patient as described in the IntelliVue Cableless Measurements Instructions for Use.Applying the CL Fetal & Maternal Patch and PodWARNINGDo not use the CL Fetal & Maternal Pod and electrode patch for monitoring if:• The skin on the abdomen of the patient has established erythema, lesions, infection, inflammation, or any kind of injuries at the applications site• The patient has a history of skin irritation, allergies, or hypersensitivity to adhesives• The patient carries multiple fetuses• The gestational age is less than 36 completed weeks. The measurement method is also only validated with patients in labor.CAUTIONDuring handling, avoid close contact of the CL Fetal & Maternal Pod or the electrode patch to an implanted pacemaker or defibrillator.
4 Cableless Monitoring101At the Mother's Side1Have a new single-use electrode patch ready, and make sure that the pouch is still intact. Check the expiration date that is printed on the pouch.2Clean the application area on the abdomen of the patient. Use mild soap to wash any cream, oil, or gel from the abdomen. Make sure to thoroughly wipe the area dry afterwards, ideally using paper towels.3Take the electrode patch from its pouch.4Study the electrode patch Instructions for Use showing the correct placement of the electrode patch on the abdomen of the patient.5Remove the cover from the adhesive area under the central area of the patch. (Do not remove the cover from any of the five surrounding electrodes yet).6Verify the correct orientation of the patch. The “Philips/Monica” printed top electrode must point to the patient’s chest.7Place the central adhesive area of the patch over the patient’s umbilicus as shown in the patch Instructions for Use. Then press it down.For patients with a displaced umbilicus:Where the umbilicus has been displaced downwards, position the center of the patch along the midline, where it intersects the horizontal line passing over the iliac crests. Alternatively, estimate the mid-point between the fundus and symphysis pubis.For very obese patients or patients with a large panniculus:An alternative strategy is to position the patch along the midline such that the edge of the top electrode is placed 10-12 cm (4-5 in) below the fundus.8Lift up one of the four electrodes. Identify the small area of the skin where you will place the center of the electrode.9Use one piece of abrasive ECG skin preparation paper to prepare the patient's skin. Make three horizontal and three vertical strokes with the skin preparation paper. Focus the strokes on the small area of the skin where the conductive center of the electrode will be placed. Make deliberate but gentle strokes, lifting the finger after each stroke.CAUTIONDo not use too much pressure with the abrasive skin preparation paper to avoid skin injury.10 Remove the protective cover from the electrode. Place the electrode on the prepared skin. Press it down firmly, but avoid pressing the central gel area of electrode.11 Repeat the steps for the skin preparation and electrode placement for the other three electrodes.incorrect correct
4 Cableless Monitoring10212 For the last remaining electrode attached to the long flexible cable, identify the small area of skin to prepare, so that the center of this reference electrode will be positioned on the midline, approximately 6 cm (2.4 in) above the rim of the symphysis pubis.For patients with a displaced umbilicus, very obese patients, or patients with a large panniculus:Place the electrode on top of the panniculus approximating to the point 6 cm (2.4 in) vertically from the symphysis pubis. If during monitoring the aFHR signal quality is poor, reposition the electrode lower down on the abdomen to maximize the FHR signal, and consider placing the electrode under the panniculus just below the turn.13 Prepare the skin like for the first four electrodes.14 Remove the protective cover from the electrode. Then place the electrode on the prepared skin and press it down firmly, but avoid pressing the central gel area of electrode.15 Assign a CL F&M Pod at the base station as described in “CL Pod Assignment” on page 99.16 Place the CL F&M Pod on the electrode patch.1CL F&M Pod and electrode patch centered on the umbilicus2Placement of electrode 6 cm (2.4 in) above the rim of the symphysis pubis
4 Cableless Monitoring103At the MonitorAfter you have placed the CL F&M Pod on the electrode patch, the cl F&M Electrode Status window opens at the monitor.In the cl F&M Electrode Status window, the electrodes and their skin contact status are shown. The skin contact status indicates, whether the skin preparation at each electrode site was successful.1There are three methods to reopen a closed cl F&M Electrode Status window. Select:–The clF&M Status SmartKey (configurable)–cl F&M Status in the setup menu of one of the CL F&M parameters (for example, Setup aFHR1)–cl F&M Status from the Main Setup menuElectrode StatusDescription What to DoThe skin contact status is good. When a good skin contact status is indicated for all five electrodes, the cl F&M Electrode Status window closes, and the measurement starts automatically.Further skin preparation may be required.1Carefully remove the electrode from the skin.2Dry the skin.3Repeat the skin preparation procedure.4If the contact status cannot be improved, you can choose to skip the electrode status check by selecting the Skip Check, Start Measurement button in the cl F&M Electrode Status window. Measurement accuracy should not be affected, but fetal heart rate detection may be less sensitive.
4 Cableless Monitoring104NOTEIf you have to repeat the skin preparation, or fix a loose electrode, ensure that enough wet gel remains in the conductive middle of the electrode during the reapplication of the electrode. Add additional fixation (any type of medical grade tape) to the pad in case the adhesive is compromised.• If you cannot get a good measurement signal quality, use an alternative monitoring method.• The electrode patch can remain applied for up to 48 hours. Remove the electrode patch, if there are signs of skin irritation.• If you have to replace an electrode patch:– Gently remove the electrode patch from the abdomen of the patient.– Wipe the abdomen dry thoroughly.– Apply a new patch over exactly the same location. In this case, no further skin preparation is required.• Monitoring with the CL F&M Pod and electrode patch can continue when the patient takes a shower. However, ensure that the CL F&M Pod remains on the electrode patch all the time, to keep the contacts of the electrode patch dry. The achievable maximum wireless operating range may be compromised when monitoring under a shower.• The CL Fetal & Maternal Pod is not intended for underwater monitoring, for example in a bathtub.CAUTIONDo not reuse a patch on another patient due to the risk of cross contamination.Further skin preparation is required. 1Carefully remove the electrode from the skin.2Dry the skin.3Repeat the skin preparation procedure.4It is not recommended to skip the electrode status check, if bad skin contact quality is persistently indicated for one or more electrodes.Electrode status is unknown. This status may be shown temporarily, or in case of a patch malfunction, combined with an INOP message.Electrode StatusDescription What to Do
4 Cableless Monitoring105After Monitoring1After monitoring is done, remove the CL F&M Pod from the electrode patch.2Clean and disinfect the CL F&M Pod, see “Care and Cleaning” on page 261.3Dock the CL F&M Pod back at the base station.4Gently remove the electrode patch and the electrodes from the abdomen of the patient.5Dispose of the electrode patch.6Remove the residuals of the adhesive from the patient's skin.CL Wide Range PodThe CL Wide Range Pod extends the signal range for the cableless measurement devices worn by the ambulating patient.1Assign the CL Wide Range Pod at the base station as described in “CL Pod Assignment” on page 99.2Activate the CL Wide Range Pod by taking it off the base station.The CL Wide Range Pod connects itself over WLAN and LAN with the fetal monitor. As soon as the connection to the monitor is established, the CL Wide Range Pod takes over from the base station, and sends the signals from the cableless devices to the monitor. The connection status of the CL Wide Range Pod is shown on the monitor, see “Cableless Status Indication” on page 95.3Hand the CL Wide Range Pod to the patient to carry with her, or optionally wearing it using the Mobile CL Transmitter Cradle (989803168881). The CL Wide Range Pod should be worn with its rear side facing the body. CL Wide Range Pod carried in hand, or CL Wide Range Pod worn with the belt clip (supporting loop and belt clip part of the optional Mobile CL Transmitter Cradle). 4While the CL Wide Range Pod is active, cableless devices can still be assigned or unassigned at the base station dynamically to the patient. To hand the signal transfer back from the CL Wide Range Pod to the base station, redock the CL Wide Range Pod at the base station.
4 Cableless Monitoring106Battery Lifetime ManagementThe lifetime of a Lithium Ion battery depends on the frequency and duration of use.CL TransducersBattery replacement is recommended after 500 charge-discharge cycles, or if the battery is older than 4 years whatever is reached first. If the battery of a cableless transducer has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is replaced. The CL transducer battery allows for 10 hours of continuous operation.Depending on the transducer type the following messages are displayed:cl US battery has aged. Replacement strongly recommendedcl Toco battery has aged. Replacement strongly recommendedcl ECG/IUP batt has aged. Replacement strongly recommendedIf you are getting this message, contact your service personnel so they can replace the CL transducer's battery.CL F&M PodPod replacement is recommended after 500 charge-discharge cycles, or if the battery is older than 4 years whatever is reached first. If the battery of a CL F&M Pod has aged and an exchange of the Pod is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened. The CL F&M battery allows for 16 hours of continuous operation.The following message is displayed:cl F&M battery has aged. Replacement strongly recommendedIf you are getting this message, contact your service personnel so they can replace the CL F&M Pod.CL Wide Range PodBattery replacement is recommended after 500 charge-discharge cycles, or if the battery is older than 4 years whatever is reached first. If the battery of a CL Wide Range Pod has aged and an exchange of the battery is highly recommended, a prompt message is displayed at the fetal monitor for ca. 60 seconds. The prompt is repeated whenever the Tele Info window is opened until the battery is replaced. The CL Wide Range Pod battery allows for 4 hours of continuous operationThe following message is displayed:cl WRP battery has aged. Replacement strongly recommendedCL NBP and CL SpO2 PodsFor battery charge-discharge cycles specification of the IntelliVue CL Pods (NBP and SpO2), refer to the Service Guide of the Cableless Measurements.Charge CycleThe age of a lithium ion battery begins at the date of manufacture. The lithium batteries are designed for frequent recharging. A complete charging cycle is only reached and counted, when all recharging periods equal a 100% charge.
4 Cableless Monitoring107The date of manufacture and number of charge-discharge cycles can be printed out in a battery report.Patient Transport Within the HospitalDuring transport, the patient wearing the CL transducers can be transferred from one fetal monitor to another fetal monitor. 1To stop monitoring, discharge the patient at the fetal monitor. Do not switch the CL base station to Standby.Note: If you switch the CL base station to Standby after the discharge, the CL transducers only hold the assignment to the CL base station for 1 minute.2Disconnect the CL base station from the fetal monitor.3The CL transducers hold the assignment to the CL base station for 30 minutes. Transport the patient wearing the CL transducers with the disconnected CL base station to another fetal monitor.4Connect the CL base station to the other fetal monitor. The fetal monitors need to have the same software revisions, and the correct time and date settings.5Manually admit the patient to the fetal monitor, unless the patient is transferred to the new fetal monitor with the OB TraceVue/IntelliSpace Perinatal system.6Resume monitoring. Once the base station and the transducer are connected and assigned to the new monitor, the previous monitor can be switched off or to Standby.
4 Cableless Monitoring108Underwater MonitoringOnly the battery-operated CL transducers of the Avalon CL and Avalon CTS systems can be used to monitor under water. You can use them to monitor patients in a bathtub or shower. This does not apply to the IntelliVue CL SpO2, CL NBP, and the CL Wide Range Pod, do not immerse the CL Pods into water.The CL F&M Pod can be worn within the shower, if the Pod is securely placed on the electrode patch, so that the contacts cannot get wet. Radio transmission range of the CL F&M Pod may be reduced under a shower.Cableless transmission distances are shorter when monitoring under water. A metal bathtub is likely to further reduce the operating range.WARNINGNever immerse the base station in liquid. You must protect it against water sprays or splashes. Place the base station where there is no chance of contact with water, or falling into water or other liquids.CAUTIONAvoid the use of pulsating water jets in the bath or shower while monitoring, as these can be misinterpreted as an incorrect (or totally artificial) heart rate.Toco Baseline drift: When using transducers under warm water, the temperature increase causes a significant baseline change due to internal pressure increase. The depth under water at which the Toco transducer is used also has an effect on the Toco baseline, as the water pressure increases with depth. After immersion, allow one to two minutes for the pressure to stabilize, then adjust the Toco baseline (between contractions), and check it frequently.When using the transducers underwater, the radio transmission range is reduced, and signal loss may occur.Water-proof belts like M1562B are recommended for the cableless transducers when monitoring in water.
51095FM20/30 Battery OptionYou can switch between battery-powered and mains-powered (AC) operation without interrupting monitoring.The monitor is connected to the AC mains power via the external power supply.NOTEThe battery option is not available for the FM40/FM50.External Power Supply M8023AThe external power supply M8023A (option #E25) allows you to operate the fetal monitor from an AC (alternating current) power source of 100 V to 240 V (±10%) and 50/60 Hz (±5%). If this option is used, then the M8023A (option #E25) power supply is included for FM20/30.
5 FM20/30 Battery Option110WARNING• Always use the supplied power cord with the earthed mains plug to connect the external power supply M8023A (option #E25) to an earthed AC mains socket. Never adapt the mains plug from the power supply to fit an unearthed AC mains socket.• Do not use AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet without an approved isolation transformer is used, the interruption of its protective earthing may result in enclosure leakage currents equal to the sum of the individual earth leakage currents, so exceeding allowable limits.• Do not connect any devices that are not supported as part of a system.• Any non-medical device placed and operated in the patient’s vicinity must be powered with an approved isolation transformer that ensures mechanical fixing of the power cords and covering of any unused power outlets.Using BatteriesThe Lithium Ion batteries used in your monitor store a large amount of energy in a small package. This allows reliable battery-operated monitoring, but also requires care in use and handling of the batteries. Follow the instructions in this chapter and see the Service Guide for further details.Battery Power IndicatorsThe battery LED and battery status information on the main screen, in combination with INOP messages and prompts, help you keep track of the battery power status. The indicators always show the remaining capacity in relation to the battery's actual maximum capacity, which may lessen as the battery ages. You can see the actual capacity in the Battery Status window.1AC power cord, connected to AC mains socket2Measurement Link (MSL) cable, supplies the power to the monitor for operation and for battery charging3Power-on LED, the green light is on when the external power supply is connected to the AC mains
5 FM20/30 Battery Option111Battery LEDThe possible battery LED status on the right side of the monitor is described in the table below.Battery Status on the Main ScreenBattery status information is permanently displayed on all screens. It shows the status of the battery, with the battery power remaining, with an estimate of the monitoring time this represents.Battery power gauge: This shows the remaining battery power. It is divided into sections, each representing 20% of the total power. If three sections are filled, as in this example, this indicates that 60% battery power remains. If no data is available from the battery, a question mark is shown in the gauge.Monitoring Time Available: Below the battery power gauge a time is displayed. This is the estimated monitoring time available with the current battery power. Note that this time fluctuates depending on the system load (the display brightness, the recorder configuration, and how many measurements you carry out).Battery LED Colors If the monitor is connected to mains power, this meansIf the monitor is running on battery power, this meansGreen Battery power is >90%Yellow Battery charging (battery power < 90%)Red, flashing Less than 10 minutes power remainingRed, flashes intermittently Battery or charger malfunction Battery malfunction
5 FM20/30 Battery Option112Battery malfunction symbols: Normal battery function is indicated by the battery power gauge, together with the remaining operating time, on the main screen. You are informed of problems or changes in the status of the battery by the battery status/malfunction indicator. This consists of a blank battery gauge containing a "!" symbol. If the symbol is red, this indicates a critical situation. You can check the specific cause of the problem by looking at the symbol(s) displayed in the Battery Status window.Battery Status Window1To access the Battery Status window and its associated pop-up keys, select the battery status information on the screen, or select Main Setup, Battery.–Capacity, remaining tells you how much power is left in the battery.–Capacity, fullCharge tells you how much power the battery can hold when fully charged.–TimeToEmpty tells you approximately how long you can continue to use the monitor without an AC connection. The time span fluctuates depending on the system load (the display brightness and how many measurements you carry out), and the remaining capacity of the battery.–TimeToFull is shown in place of TimeToEmpty if the monitor is connected to a power supply, and tells you how much time is left until the battery is charged to 90%. If >10 hr is shown here, the battery may not charge completely when the monitor is in use.Battery status/malfunction symbols: If a problem is detected with the battery, an INOP may be issued, and the following symbols are displayed in the Battery Status window, where they may be accompanied by a status message providing more details.Battery Status Indicator Battery Malfunction IndicatorAlternates with the battery gauge on the main screen.Check in the Battery Status window to see which status symbol is displayed to identify the cause.The red exclamation mark flashes. Critical battery situation or malfunction. Check in the Battery Status window to see which malfunction indicator is displayed, or refer to the INOP, to identify the cause.
5 FM20/30 Battery Option113Symbols indicating critical situations are colored red.Checking Battery ChargeTo check the charge status of a battery, refer to the battery power gauge on the screen, or open the Battery Status window.When Battery Lifetime is ExpiredWhen the battery is aged, either after 3 years from manufacturing date or after 500 charge-discharge cycles, it is recommended to replace the battery. To remind you of this, a message will appear in the Battery Status window. This message will only be displayed at the appropriate time when the date and time on the monitor is correct.Optimizing Battery PerformanceThe performance of rechargeable batteries may deteriorate over time. Battery maintenance as recommended here can help to slow down this process.Display Brightness Setting1In the Main Setup menu, select User Interface, Brightness, then Optimum. This selects a level of brightness suitable for most monitoring locations that uses less battery power than brighter settings.2Ensure that the current level of brightness is suitable for your monitoring location.Battery Status Symbols Battery Malfunction SymbolsBattery is empty (Red) incompatible batteryBattery not charging as the temperature is above or below the specified range(Red) battery malfunctionBattery requires maintenance (Red) battery has no power leftCharging stopped to protect the battery(Red) battery temperature too high(Red) battery is missing, insert battery
5 FM20/30 Battery Option114Charging the BatteryTo charge the battery:1Connect the monitor to the external power supply (M8023A).2Charge the battery until it is full, the battery LED is green, and the battery power gauge is filled.During high load of the monitor (usage of multiple measurements) the battery may not charge. To remedy this:• reduce the load by removing measurements• reduce the screen brightness or stop the recorderInternal temperature conditions can also cause the battery to not charge. This is necessary to protect the battery from damage and does not indicate a malfunction. Keep the monitor at room temperature and move it away from heat sources or out of direct sunlight. The battery will resume charging when the temperature is within range again. The battery will charge more quickly if the monitor is switched off.Conditioning the BatteryYou must condition the battery when the "battery requires maintenance" symbol shows on the screen. Do not interrupt the charge or discharge cycle during conditioning.CAUTIONCondition the battery with a monitor not currently in use. The monitor switches off automatically when there is no battery power left.To condition the battery:1Charge the battery until it is completely full. Open the Battery Status window and check that the Batt fully charged message is displayed.2Disconnect the monitor from mains power, and let the monitor run until there is no battery power left and the monitor switches itself off.3Reconnect the monitor to mains power and charge the battery until it is full for use or charge to 50% for storage.
5 FM20/30 Battery Option115Battery Safety InformationWARNINGUse only Philips batteries part number M4605A. Use of a different battery may present a risk of fire or explosion.Do not open batteries, or dispose of them in fire, or cause them to short circuit. They may ignite, explode, leak, or heat up, causing personal injury.If battery leakage should occur, avoid contact with skin. Refer to qualified and authorized service personnel.Dispose of used batteries promptly and in an environmentally responsible manner. Do not dispose of the battery in normal waste containers. Consult your hospital administrator to find out about local arrangements. Do not expose batteries to liquids.Do not crush, drop, or puncture batteries - mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally.If a battery has been dropped or banged against a hard surface, whether damage is visible externally or not:• discontinue use• dispose of the battery in accordance with the disposal instructions above.Keep batteries out of the reach of children.CAUTIONDo not disassemble, heat above 100°C (212°F) or incinerate the batteries, to avoid the risk of fire and burns. Keep batteries out of the reach of children and in their original package until you are ready to use them.If battery leakage should occur, use caution in removing the battery. Avoid contact with skin. Refer to qualified and authorized service personnel.Do not install or use pre-damaged batteries.Storing the BatteryWARNINGRemove the battery from the monitor when it is not used for a longer period of time, to avoid potential damage caused by battery leakage.Batteries should be charged to a maximum of 50% for storage.The battery will discharge over time if it is stored inside the monitor without AC power connection. The reported values for "remaining capacity" and "runtime" will become less accurate when the battery is stored in this way for a longer period of time (that is, several weeks).
5 FM20/30 Battery Option116Cableless Monitoring with FM20/30 Battery OptionThe CL Pods can be used with the FM20/30 with battery option #E25. The CL Pods can be assigned and activated, but will not be charged. The only exception to this is the CL F&M Pod, which can also be charged.The charging time of the CL transducers can take up to 6 hours if they are charged from an FM20/30 with battery option.If you charge the CL transducers at an FM20/30 with battery option, be sure to remove all wired transducers from the fetal monitor. Leaving them connected to the fetal monitor can cause the CL transducers not to charge at all.Patient Transport Within the HospitalThe FM20 and FM30 fetal monitor with battery option offer the possibility of continuous monitoring of a patient, while she is transported within the hospital.1Unplug the MSL connector at the fetal monitor. Or, in case an external power supply is mounted on a rollstand, unplug it from the AC Mains.The fetal monitor is now operating on battery power.2Move the patient with the fetal monitor (on a cart) to the new location.3Reconnect the MSL connector at the fetal monitor or the external power supply to the AC Mains.
61176AlarmsThe alarm information here applies to all measurements. Measurement-specific alarm information is contained in the sections on individual measurements.The fetal monitor has two different types of alarm: patient alarms and INOPs.Patient AlarmsPatient alarms are red and yellow alarms. A red alarm indicates high priority, such as a potentially life threatening situation (for example, SpO2 below the desaturation alarm limit). A yellow alarm indicates a lower priority alarm (for example, a fetal heart rate alarm limit violation).INOPsINOPs are technical alarms. They indicate that the monitor cannot measure and therefore not detect critical conditions reliably. If an INOP interrupts monitoring and alarm detection (for example, MECG Leads Off), the monitor places a question mark in place of the measurement numeric and sounds an audible tone. INOPs without this tone indicate that there may be a problem with the reliability of the data, but that monitoring is not interrupted.INOPs are cyan by default. The following INOPs can also be configured as red or yellow INOPs to provide a severity indication:•ECG Leads Off•Battery Empty (FM20/30, CL devices)•Cuff Overpress•Cuff NotDeflated•No PulseAlarm DelaysThere is a delay between a physiological event at the measurement site and the corresponding alarm indication at the monitor. This delay has two components:•The general measurement delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and on the measurement dependent averaging time.
6 Alarms118•The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the monitor. This delay is the sum of the alarm delay configured for the specific measurement plus the system alarm delay. The system alarm delay is the processing time the system needs for any alarm on the monitor to be indicated after the measurement has triggered the alarm. See the performance specifications in “Specifications and Standards Compliance” on page 287 for the system alarm delay specification.Multiple AlarmsIf more than one alarm is active, the alarm messages are shown in the alarm status area in succession. An arrow symbol next to the alarm message informs you that more than one message is active.The monitor sounds an audible indicator for the highest priority alarm. If more than one alarm condition is active in the same measurement, the monitor announces the most severe alarm condition first.WARNINGAlarm systems of the monitor and those of the connected obstetrical information and surveillance system are independent and not synchronized.Alarming is only available at the Avalon fetal monitor, not at the Cableless Measurement Devices, see the Instructions for Use for the IntelliVue Cableless Measurements.If configured so, SpO No Pulse will only be displayed in yellow or red (instead of cyan), when no other Pulse source is valid and is displayed instead of the Pulse from SpO2.Alarm ModeYou can configure the alarm mode for your fetal monitor. There are two possible modes:•All: alarms and INOPs are enabled, with all audible and visual indicators active.•INOP only: only INOPs are enabled, with audible and visual indication active.WARNINGIn INOP only mode, no fetal/maternal patient alarms are enabled or indicated.The alarm status area for yellow and red alarms shows the INOP only indication in conjunction with the "Alarms Off" symbol. No individual measurement alarm limits or alarm off symbols are displayed. No fetal/maternal patient alarm settings are available in the setup menus.Nurse Call SystemsIf configured to do so, red, yellow, and cyan alarms are indicated on a nurse call system which is connected to the optional nurse call relay.
6 Alarms119Visual Alarm IndicatorsAlarm message: An alarm message appears in the alarm status area on the second line at the top of the screen indicating the source of the alarm. If more than one measurement is in an alarm condition, the message changes every two seconds, and has an arrow at the side. The background color of the alarm message matches the alarm priority: red for red alarms and red INOPs, yellow for yellow alarms and yellow INOPs, and cyan for INOPs. The asterisk symbols (*) beside the alarm message match the alarm priority: *** for red alarms, and ** for yellow alarms. INOPs are displayed without asterisks, but a red INOP has !!! three exclamation marks, and a yellow INOP has !! two exclamation marks before it.Depending on how your monitor is configured, it may display alarm limit violation messages:• in text form, for example ** FHR1 Low or• in numeric form, for example **FHR1 94<110, where the second number shows the currently set alarm limit, and the first number shows the value at which that alarm limit was violated by the widest margin.Flashing numeric: The numeric of the measurement in alarm flashes.Bright alarm limits: If the alarm was triggered by an alarm limit violation, the corresponding alarm limit on the monitor screen is shown more brightly.Audible Alarm IndicatorsThe audible alarm indicators configured for your fetal monitor depend on which alarm standard applies in your hospital. Audible alarm indicator patterns are repeated until you acknowledge the alarm by switching it off or pausing it, or until the alarm condition ceases (if audible alarm indication is set to non-latching).WARNINGDo not rely exclusively on the audible alarm system for fetal monitoring. Adjustment of alarm volume to a low level or off during monitoring may result in a dangerous situation. Remember that the most reliable method of fetal monitoring combines close personal surveillance with correct operation of monitoring equipment.Alarm Tone ConfigurationThe audible alarm indicators of your monitor are configurable. In the monitor's Configuration Mode, you can:• increase the alarm volume of unacknowledged alarms at regular intervals• change the interval between alarm sounds (ISO/IEC Standard alarms only)• change the base volume of the red and yellow alarm tones and the INOP tones• change the alarm sound to suit the different alarm standards valid in different countries
6 Alarms120Standard Philips Alarms• Red alarms and red INOPs: a high pitched sound is repeated once a second.• Two-star yellow alarms and yellow INOPs: a lower pitched sound is repeated every two seconds.• One-star yellow alarms (short yellow alarms): the audible indicator is the same as for yellow alarms, but of shorter duration.• Standard INOPs: an INOP tone is repeated every two seconds.ISO/IEC Standard Audible Alarms• Red alarms and red INOPs: a high pitched tone is repeated five times, followed by a configurable pause.• Two-star yellow alarms and yellow INOPs: a lower pitched tone is repeated three times, followed by a configurable pause.• One-star yellow alarms (short yellow alarms): the audible indicator is the same as for yellow alarms, but of shorter duration.• Standard INOPs: a lower pitched tone is repeated twice, followed by a pause.Changing the Alarm Tone VolumeThe alarm volume symbol at the top right of the monitor screen gives you an indication of the current volume. To change the volume:1Select the volume symbol.2The volume scale pops up.3Select the required volume from the volume scale.When the alarm volume is set to zero (Off), the alarm volume symbol shows this symbol:If you switch the alarm volume off, you will not get any audible indication of alarm conditions.1 Alarm Volume
6 Alarms121Minimum Volume for Severe Yellow or Red INOPsSevere yellow or red INOPs require action to ensure the well-being of the patient. Therefore the minimum volume for the INOP tone is set to at least alarm volume 8, irrespective of the current alarm volume setting. The INOP tone will sound even if the monitor alarm volume is set to zero.The severe INOPs for which this applies are:Power Loss ToneFM20/30 with BatteryOption,FM40/50When power is lost - no power is available from the AC power source or from the battery - a beeper will sound. The tone can be silenced by pressing the On/Standby button.Acknowledging AlarmsTo acknowledge all active alarms and INOPs, select the Silence key. This switches off the audible alarm indicators.• A checkmark beside the alarm message indicates that the alarm has been acknowledged.• If the condition that triggered the alarm is still present after the alarm has been acknowledged, the alarm message stays on the screen with a checkmark symbol beside it.• If the alarm condition is no longer present, all alarm indicators stop and the alarm is reset.• Switching off the alarms for the measurement in alarm, or switching off the measurement itself, also stops alarm indication.Acknowledging Disconnect INOPsAcknowledging an INOP that results from a disconnected transducer, switches off the associated measurement.INOP Factory Default INOP toneBattery Emptycyan severe (fetal monitor with battery option)Battery Emptycyan severe (CL transducers and Pods)Cuff Overpresscyan severeCuff NotDeflatedcyan severe
6 Alarms122Alarm ReminderIf Alarm Reminder is configured on for your monitor, you will get an audible reminder of alarm conditions that remain active after you have acknowledged the alarm. This reminder may take the form of a repetition of the alarm tone for a limited time, or an unlimited repetition of the alarm tone (this is the same as a new alarm). Alarm Reminder is available only for yellow and red alarms and INOPs and not for standard cyan INOPs.In Configuration Mode, you can set the interval between silencing the alarm and sounding the reminder tone to one, two, or three minutes.Pausing or Switching Off AlarmsIf you want to temporarily prevent alarms from sounding, for example while you are moving a patient, you can pause alarms. Depending on your fetal monitor configuration, alarms are paused for one, two, or three minutes, or infinitely.To view the alarm pause setting chosen for your unit:1Select Main Setup, Alarms, Alarm Settings.2Check the Alarms Off setting.This setting can be changed in Configuration Mode.There are some settings made in Configuration Mode that can affect the availability of the pause alarms functionality.•The Pause Alarms/Alarms Off SmartKey can be removed from the screen to avoid unintentional switching off of alarms. In this case you can only pause alarms or switch alarms off permanently in the Alarms menu, under Main Setup.•The Pause Alarms/Alarms Off SmartKey can be configured to pause or switch off red and yellow alarms, yellow alarms only, or not to function at all. If it is configured not to function, you cannot pause alarms or switch alarms off permanently at all.When the alarms off priority is set to Yellow Only, the Pause Alarms/Alarms Off key becomes the Pause Yellow/Yellow Al. Off.To Pause All AlarmsIf you have configured alarms to be paused for one, two, or three minutes, the SmartKey is labeled Pause Alarms.Select the Pause Alarms SmartKey to pause all alarms.Or1Select Main Setup.2Select Alarms.3Select Pause Alarms.
6 Alarms123To Switch All Alarms OffYou can switch alarms off permanently if your monitor is configured to allow infinite alarms pause, and the SmartKey is labeled Alarms Off.Select the Alarms Off SmartKey.Or1Select Main Setup.2Select Alarms.3Select Alarms Off.While Alarms are Paused or OffWhen red alarms are paused or off:In the alarm field, the monitor displays the message Al. Paused x:yy or Alarms Off, together with the alarms paused symbol or the alarms off symbol.When yellow alarms are paused or off:In the alarm field, the monitor displays the message YellowPaused x:yy or Yellow Alarms Off, together with the alarms paused symbol or the alarms off symbol.For red and yellow alarms: Alarms Paused Alarms Off• No alarms are sounded and no alarm messages are shown.• INOP messages are shown but no INOP tones are sounded.The only exceptions are the INOPs Cuff NotDeflated, Cuff Overpress, and Battery Empty from the FM20/30 monitor with battery option.These INOPs switch all alarms back on again, so that an INOP tone can be sounded. You must remove the INOP condition first, before you can switch off or pause the alarms again.Restarting Paused AlarmsTo manually switch on alarm indication again after a pause, select the SmartKey Pause Alarms (or Alarms Off) again.Alarm indication starts again automatically after the pause period expires. If the monitor is configured to stay paused infinitely, you must select Alarms Off again to restart alarm indication.
6 Alarms124Extending the Alarm Pause TimeIf your monitor has the function extended alarm pause enabled, you can extend the alarm pause time. Use this to prevent alarms being indicated, for example, while you are washing a patient or carrying out a procedure. Only extend the alarm pause time when you are sure that clinical personnel are available to monitor the patient's condition closely.To extend the alarm pause time to five or 10 minutes:1Select one of the alarm fields. This calls up the Alarm Messages window.2Select either the pop-up key PauseAl. 5 min or the pop-up key PauseAl. 10 min. Each time you select one of these pop-up keys, the Alarm Pause Time is reset to five or 10 minutes.To Switch Individual Measurement Alarms On or OffThis applies to alarm mode All.1Select the measurement numeric to enter its setup menu.2Select Alarms to switch between On and Off.The alarms off symbol is shown beside the measurement numeric.Alarm LimitsThe alarm limits you set determine the conditions that trigger yellow and red limit alarms.WARNINGBe aware that the monitors in your care area may each have different alarm settings, to suit different scenarios. Always check that the alarm settings are appropriate before you start monitoring.Viewing Individual Alarm Limits (Alarm Mode "All" Only)You can usually see the alarm limits set for each measurement next to the measurement numeric on the main screen.1Alarm Limits
6 Alarms125If your monitor is not configured to show the alarm limits next to the numeric, you can see them in the related measurement setup menu. Select the measurement numeric to enter the menu and check the limits.Changing Alarm LimitsTo change individual measurement alarm limits using the measurement's setup menu:1In the measurement's setup menu, select the alarm limit you want to change. This calls up a list of available values for the alarm limit.2Select a value from the list to adjust the alarm limit.CAUTIONSet the alarm limits to a meaningful value for the individual patient. Setting the alarm limits to a too high or too low value may render the alarm function useless.Extreme Alarm Limits for Heart Rate and Maternal PulseThe extreme rate alarms, Extreme Tachy and Extreme Brady, generated by the active alarm source, either HR or Pulse, are set in Configuration Mode by adding a set value (the Δ value) to the high and low alarm limits.You need to know which value has been configured for your monitor. Changing the high and low alarm limits automatically changes the extreme alarm limits within the allowed range.To see the extreme rate alarms set for your monitor, in the Setup ECG menu, see the menu items  ExtrTachy and  ExtrBrady.1Extreme Brady Limit2Low Limit3High Limit4Extreme Tachy Limit5Δ Extreme Brady6Δ Extreme Tachy
6 Alarms126Reviewing AlarmsTo review the currently active alarms and INOPs, select any of the alarm status areas on the fetal monitor screen. The Alarm Messages window pops up. All alarms and INOPs are erased from the monitor's alarm history when you discharge a patient, or if you leave the Demonstration Mode.Alarm Messages WindowThe Alarm Messages window shows all the currently active alarms and INOPs in chronological order, beginning at the top with the most recent. INOPs are shown on the left hand side, and alarms are shown on the right hand side. Any active red alarms are shown first, followed by yellow alarms. Acknowledged alarms or INOPs are shown with the checkmark symbol.The Alarm Messages window pop-up keys appear when the window is opened. Selecting the Review Alarms pop-up key opens the Review Alarms window.Review Alarms WindowThe Review Alarms window contains a list of up to 300 of the most recent alarms and INOPs with date and time information. If configured to do so, each alarm is shown with the alarm limit active when the alarm was triggered and the maximum value measured beyond this limit. The Review Alarms window also shows any changes made to the Alarms On/Off or Alarms Silenced status. Only the main alarms On/Off transitions are logged in the alarm history, and On/Off alarm transitions for individual measurements are not logged.The information in the Review Alarms window is deleted when a patient is discharged.The Review Alarms window pop-up keys appear when the window is opened. Selecting the Active Alarms pop-up key opens the Alarm Messages window.Latching AlarmsThe alarm latching setting for your monitor defines how the alarm indicators behave when you do not acknowledge them. When alarms are set to non-latching, their indicators end when the alarm condition ends. Switching alarm latching on means that visual and/or audible alarm indications are still displayed or announced by the monitor after the alarm condition ends. The indication lasts until you acknowledge the alarm.1Alarms On2SpO No Pulse3Alarms Silenced4** FHR1 High5** SpO Low
6 Alarms127Viewing the Alarm Latching SettingsTo see the alarm latching setting for your monitor:1In the monitor's Main Setup menu, select Alarms.2Select Alarm Settings, and see the Visual Latching and Audible Latching settings.This setting can be changed in Configuration Mode. You should be aware of the settings chosen for your unit. There are three possible choices each for visual and audible latching: Red & Yellow, Red Only, and Off. The audible latching configuration can never be configured to a higher level than that configured for the visual latching. In other words, the audible latching setting is always the same level, or lower, than the visual latching setting. For example, if visual latching is configured to Red Only, then audible latching can only be set to Red Only or Off. The following table shows the possible combinations for latching settings:Alarm Latching BehaviorAll INOPs except the "unplugged" INOPs are non-latching.Possible Combinations for Alarm Latching SettingsVisual Latching Setting Audible Latching SettingRed & Yellow Red & YellowRed & Yellow Red OnlyRed & Yellow OffRed Only Red OnlyRed Only OffOff OffAlarm Condition Red and Yellow Measurement AlarmsAcknowledgment Presence Non-latching alarms Visual and audible latchingVisual latching, audible non-latchingAlarm has not been acknowledgedAlarm condition still presentAlarm tone on Alarm message Flashing numericsAlarm tone on Alarm message Flashing numericsAlarm tone on Alarm message Flashing numericsAlarm condition no longer presentAll audible and visual alarm indicators automatically stopAlarm tone on Alarm message Flashing numericsAudible alarm indicators automatically stop Alarm message Flashing numerics Alarm has been acknowledgedAlarm condition still presentAlarm tone off Audible alarm reminder (if configured) Alarm message Flashing numericsAlarm tone off Audible alarm reminder (if configured) Alarm message Flashing numericsAlarm tone off Audible alarm reminder (if configured) Alarm message Flashing numericsAlarm condition no longer presentAudible and visual alarm indicators automatically stopAudible and visual alarm indicators automatically stopAudible and visual alarm indicators automatically stop
6 Alarms128Testing AlarmsWhen you switch the fetal monitor on, a self test is started. You should hear a single tone. This indicates that the audible alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on yourself (for example SpO2 or NBP) or use a simulator. Adjust alarm limits and check that appropriate alarm behavior is observed.To test the functioning of visible and audible alarms, do the following:1Enable the alarm (Alarm Mode needs to be set to All, see the Configuration Guide).2Set the alarm limits.3Measure or simulate the parameter that is out of range, or signal loss.4Verify that the visible and audible alarms are working.As an example, to test the FHR alarms:1Connect the US transducer to a fetal sensor socket.2Enable the FHR alarming (see “Turning Alarms On or Off” on page 197).Set the high alarm limit and delay to 150 bpm and 60 seconds respectively, and the low alarm limit and delay to 110 bpm and 60 seconds respectively (see “Changing Alarm Limits” on page 197).1Generate a fetal heart rate of approximately 180 bpm (3 beats per second) for more than one minute.2Verify the functioning of the visible and audible alarms.Alarm Behavior at Power OnIf the monitor is switched off for longer than one minute and then switched on again, or after a loss of power lasting longer than one minute, the monitor can be configured to restore either the alarm settings from the monitor's User Defaults, or the most recently used alarm settings. When a patient is discharged, the User Defaults of the monitor are always restored independent of the setting. After any of these situations, ensure that the alarm settings are appropriate for your patient. If power is lost for less than one minute, the alarm settings prior to the power loss are restored.•If AlarmsOffAtStart is enabled in Configuration Mode alarms will be initially paused or off the next time the monitor is switched on, depending on a set of related configuration settings, see the Configuration Guide.
71297Patient Alarms and INOPsThis chapter lists alarms and technical alarms (INOPs) for the fetal monitors irrespective of their priority.Alarm MessagesFetal alarms are identified by either "FHR", "dFHR", or aFHR. All other alarms without these identifiers refer to maternal parameters. Alarm messages can be configured with the Enhanced setting to give more information. These messages are shown additionally in the table below, with xxx for the measured value and yyy for the alarm limit concerned.Alarm Message From Condition Indication** aFHR1 High ** aFHR2 High ** aFHR3 High** aFHR1 xxx>yyy ** aFHR2 xxx>yyy ** aFHR3 xxx>yyyFHR (CL F&M Pod)The fetal heart rate obtained from the CL F&M Pod has risen above the high alarm limit.xxx denotes the highest measured value, and yyy is the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** aFHR1 Low ** aFHR2 Low ** aFHR3 Low** aFHR1 xxx<yyy ** aFHR2 xxx<yyy ** aFHR3 xxx<yyyFHR (CL F&M Pod)The fetal heart rate obtained from the CL F&M Pod has fallen below the low alarm limit.xxx denotes the lowest measured value, and yyy is the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.**aHR High**HR xxx<yyyHR (CL F&M Pod)The maternal heart rate obtained from the CL F&M Pod has risen above the high alarm limit.xxx denotes the highest measured value, and yyy is the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.**aHR Low**HR xxx>yyyHR (CL F&M Pod)The maternal heart rate obtained from the CL F&M Pod fallen below the low alarm limit.xxx denotes the lowest measured value, and yyy is the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.
7 Patient Alarms and INOPs130*** Brady (Pulse)***Brady/P xxx<yyySpO2The heart rate from the Pulse signal has fallen below the bradycardia limit.xxx denotes the lowest measured value; yyy is the bradycardia limit.Numeric flashes, red alarm message, alarm tone.*** Desat*** Desat xx < yySpO2The SpO2 value has fallen below the desaturation alarm limit. xx denotes the lowest measured value, and yy is the desaturation limit.Numeric flashes, red alarm message, alarm tone.** dFHR1 High ** dFHR2 High ** dFHR3 High**dFHR1 xxx>yyy **dFHR2 xxx>yyy **dFHR3 xxx>yyyFHR (DECG) The fetal heart rate obtained from DECG has risen above the high alarm limit.xxx denotes the highest measured value, and yyy is the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** dFHR1 Low ** dFHR2 Low ** dFHR3 Low**dFHR1 xxx<yyy **dFHR2 xxx<yyy **dFHR3 xxx<yyyFHR (DECG) The fetal heart rate obtained from DECG has fallen below the low alarm limit.xxx denotes the lowest measured value, and yyy is the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.*** Extreme Brady***xBrady xxx<yyyMECG The maternal heart rate obtained from the maternal ECG has fallen below the extreme bradycardia limit.xxx denotes the lowest measured value, and yyy is the extreme bradycardia limit.Numeric flashes, red alarm message, alarm tone.*** Extreme Tachy***xTachy xxx>yyyMECG The maternal heart rate obtained from the maternal ECG has risen above the extreme tachycardia limit.xxx denotes the highest measured value, and yy is the extreme tachycardia limit.Numeric flashes, red alarm message, alarm tone.** FHR1 High ** FHR2 High ** FHR3 High**FHR1 xxx>yyy **FHR2 xxx>yyy **FHR3 xxx>yyyFHR (ultrasound)The fetal heart rate obtained from ultrasound has risen above the high alarm limit.xxx denotes the highest measured value, and yyy is the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** FHR1 Low ** FHR2 Low ** FHR3 Low**FHR1 xxx<yyy **FHR2 xxx<yyy **FHR3 xxx<yyyFHR (ultrasound)The fetal heart rate obtained from ultrasound has fallen below the low alarm limit.xxx denotes the lowest measured value, and yyy is the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.Alarm Message From Condition Indication
7 Patient Alarms and INOPs131** HR High**HR xxx>yyyMECG The maternal heart rate obtained from the maternal ECG has risen above the high alarm limit.xxx denotes the highest measured value, and yyy is the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** HR Low**HR xxx<yyyMECG The maternal heart rate obtained from the maternal ECG has fallen below the low alarm limit.xxx denotes the lowest measured value, and yyy is the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.** <iTemp Label> HighiTemp The temperature value has exceeded the high alarm limit.Numeric flashes and high limit is highlighted, alarm tone.** <iTemp Label> LowiTemp The temperature value has dropped below the alarm limit.Numeric flashes and low limit is highlighted, alarm tone.** NBPs High ** NBPd High ** NBPm HighNoninvasive blood pressureThe measured noninvasive blood pressure value is above the high alarm limits s, d, or m after the label indicates whether the systolic, diastolic, or mean pressure has crossed the limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** NBPs Low ** NBPd Low ** NBPm LowNoninvasive blood pressureThe measured noninvasive blood pressure value is below the low alarm limits s, d, or m after the label indicates whether the systolic, diastolic, or mean pressure has crossed the limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.** Pulse HighSpO2The pulse rate has exceeded the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** Pulse LowSpO2The pulse rate has dropped below the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.** SpO HighSpO2The arterial oxygen saturation has exceeded the high alarm limit.Numeric flashes and high limit is highlighted, yellow alarm message, alarm tone.** SpO LowSpO2The arterial oxygen saturation has fallen below the low alarm limit.Numeric flashes and low limit is highlighted, yellow alarm message, alarm tone.*** Tachy (Pulse)***Tachy/P xxx>yyySpO2The heart rate from the Pulse signal has exceeded the tachycardia limit.xxx denotes the highest measured value, and yyy is the tachycardia limit.Numeric flashes, red alarm message, alarm tone.Alarm Message From Condition Indication
7 Patient Alarms and INOPs132Technical Alarm Messages (INOPs)Monitor INOPsINOP Message Indication What to do2nd Tele IncompatibleMonitor: INOP tone One of the connected base stations is not supported by the monitor. Check software revisions.Bus Master IncompMonitor: INOP tone The Bus Master board or firmware is incompatible and cannot be used with this monitor software revision. Contact your service personnel.Bus Master MalfuncMonitor: INOP tone There is a problem with the monitor's hardware. Contact your service personnel.Check Flex TextsMonitor: INOP tone If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel.Check KeyboardMonitor: INOP tone Perform a visual and functional check of the keyboard. Contact your service personnel.Check Monitor FuncMonitor: INOP tone A potential internal problem with the monitor has been detected. Contact your service personnel.Check MouseMonitor: INOP tone Perform a visual and functional check of the mouse input device. Contact your service personnel.Check OBR ConfigMonitor: INOP tone OBR (OB Radio) channel configuration is invalid or settings are not present. Check channel configuration and hardware option.Check SettingsMonitor: INOP tone If this INOP appears, check the monitor and patient settings before you resume monitoring. If the settings are unexpected, there may be a problem with the monitor software. Contact your service personnel.Check TI ConfigMonitor: INOP tone If this INOP appears, the monitor can be used normally, except for the Trace Interpretation feature. Contact your service personnel.Check Touch InputMonitor: Display only Perform a visual and functional check of the touch input device. Contact your service personnel.Coincidence !! CoincidenceMonitor: INOP tone The fetal heart rate(s) and maternal heart rate/pulse persistently coincide with another. (see “Cross-Channel Verification (CCV)” on page 159). The INOP tone has a configurable delay. The default setting is an instant INOP tone.Internal.Comm.MalfMonitor: INOP tone There is a problem with I2C Bus communication in the monitor. Contact your service personnel.NST ElapsedMonitor: INOP tone(Message and tone only if Setup NST Timer, Notification is set to Alarm in Configuration Mode).The time has expired for the NST timer. Clearing the timer clears the INOP.
7 Patient Alarms and INOPs133FM20/FM30 Battery INOPsOBR InterferenceMonitor: INOP tone OBR (OB Radio) communication is disturbed by other devices (not necessarily other wireless measurements). Contact service personnel.Paper EndMonitor: INOP tone The end of the paper pack is detected. Insert a new pack of paper.Settings MalfunctMonitor: INOP tone The monitor cannot use the predefined settings for monitoring. Contact your service personnel.Speaker MalfunctMonitor: INOP tone Contact your service personnel to check the speaker and the connection to the speaker.SRR IncompatibleMonitor: INOP tone The connected SRR (Short Range Radio) board or firmware cannot be used with this base station's software revision. Contact your service personnel.SRR InterferenceMonitor: INOP tone The short range radio connection has interference from another device. Try using another channel.SRR Invalid ChanMonitor: INOP tone The channel configuration of the Short Range Radio is invalid. Check channel and channel mask configuration.SRR MalfunctionMonitor: INOP tone Malfunction in the SRR (Short Range Radio) module(s). If the INOP persists, contact your service personnel.Tele IncompatibleMonitor: INOP tone The base station is not supported by the monitor. Check software revisions.Tele MalfunctionMonitor: INOP tone Malfunction of the connected base station. If the INOP persists contact your service personnel.Tele UnpluggedMonitor: INOP tone The base station has been disconnected from the monitor, while one or more CL devices were active. This INOP is only issued, if the setting Sensor Disconnct is No Auto Off, or the Alarm Mode is set to All.Unsupported LANMonitor: INOP tone There is a problem with the communication to the network and central monitoring is currently not possible. Check the connection. If the INOP persists, switch off the monitor and contact your service personnel.User I/F MalfunctMonitor: INOP tone Perform a visual and functional check of all the monitor input devices. Contact your service personnel.INOP Message Indication What to doINOP Message Indication What to doBatt EmptyMonitor: INOP toneBattery LED at the monitor flashes. During this INOP, alarms cannot be paused or switched off.The estimated remaining battery-powered operating time is less than 10 minutes. Connect the monitor to AC immediately.If the condition persists and the monitor is not connected to mains power, this INOP is re-issued two minutes after you acknowledge it.Batt IncompatMonitor: INOP tone The battery cannot be used with this monitor. Replace it with the correct battery.
7 Patient Alarms and INOPs134Recorder INOPsBatt LowMonitor: INOP tone The estimated battery-powered operating time remaining is less than 20 minutes.Batt MalfunctionMonitor: INOP toneBattery at the monitor flashes. During this INOP, alarms cannot be paused or switched off unless the monitor is connected to mains power.The monitor cannot determine the battery status. If the INOP persists, replace the faulty battery. If the condition persists and the monitor is not connected to mains power, this INOP is reissued two minutes after you acknowledge it.Batt MissingMonitor: INOP tone No battery found in FM20/30. Contact your service personnel.Charger MalfunctMonitor: INOP toneBattery at the monitor may flash.There is a problem with the battery charger in the monitor. Connect the monitor to mains power and contact your service personnel.Check Batt TempMonitor: INOP tone The temperature of the battery is too high. Check that the monitor is not exposed to heat.INOP Message Indication What to doINOP Message Indication What to doCheck PaperMonitor: display onlyRecorder: printoutCheck that there is no paper jam, that the print drawer is properly shut, that the paper is loaded with the grid facing upwards, and that the correct Philips paper is being used.FetRec Chk ConfigMonitor: INOP toneRecorder Speed and/or Scale Type settings are set to Unknown and need to be set to the correct values in Configuration Mode before the recorder can be operated.FetRec Equip MalfMonitor: INOP tone There is a problem with the fetal recorder hardware. Contact your service personnel.Printhead OverheatMonitor: INOP tone The printhead is too hot. The recorder stops, the recorder Start/ Stop key is disabled, and remains so until the printhead cools down sufficiently. Wait for the printhead to cool down, then press the recorder Start/ Stop key or the Silence key to clear the INOP.Wrong Paper ScaleMonitor: INOP toneRecorder: printoutThe grid scale of the paper in the monitor does not match the grid scale configured in the monitor. Make sure that you use the correct paper and scale for your institution: pre-printed: 30-240 in US and Canada, 50-210 in other geographies.
7 Patient Alarms and INOPs135Wired Transducer INOPsFHR (Ultrasound)IUPTocoINOP Message Indication What to doFHR1 Equip Malf FHR2 Equip Malf FHR3 Equip MalfMonitor: INOP tone There is a problem with the FHR hardware. Contact your service personnel.FHR1 Signal Loss FHR2 Signal Loss FHR3 Signal LossMonitor: INOP toneINOP tone if Alarm Mode is set to All. No tone if Alarm Mode is set to INOP only.The input signal quality is not sufficient to process the measurement. Adjust the position of the transducer to obtain a better signal.FHR1 Unplugged FHR2 Unplugged FHR3 UnpluggedMonitor: INOP tone Reconnect the FHR transducer to the monitor. Check if all connections are sound.INOP Message Indication What to doIUP Equip MalfMonitor: INOP tone There is a problem with the IUP hardware. Contact your service personnel.IUP UnpluggedMonitor: INOP tone Reconnect the IUP transducer to the monitor. Check if all connections are sound.INOP Message Indication What to doPulse(Toco) MalfMonitor: INOP toneToco MP Maternal Pulse MeasurementThere is a problem with the Toco MP transducer hardware. Contact your service personnel.Toco Equip MalfMonitor: INOP tone There is a problem with the Toco hardware. Contact your service personnel.Toco UnpluggedMonitor: INOP tone Reconnect the Toco transducer to the monitor. Check if all connections are sound.
7 Patient Alarms and INOPs136Cableless Transducer INOPsINOP Message Indication What to docl US Batt Empty !!cl US Batt Empty !!!cl US BattEmptycl Toco Batt Empty !!clToco BattEmpty !!!clTocoBattEmptycl ECG/IUP Empty !!cl ECG/IUP Empty !!!clECG/IUP EmptyMonitor: INOP tone (configurable cyan, yellow, red)CL transducer: yellow tone and LED flashes redThe remaining monitoring time with this transducer is below 15 minutes. Charge battery.cl US Batt Low cl Toco Batt Low cl ECG/IUP BattLowMonitor: Display onlyCL transducer: LED flashes redThe remaining monitoring time with this transducer is below 30 minutes. Charge battery.cl US Batt Malf cl Toco Batt Malf clECG/IUP BattMalfMonitor: INOP toneCL transducer: tone and cyan LEDMalfunction of the battery system (charger circuit or battery) detected (e.g. persistent communication error, overvoltage, overcurrent, battery incompatible). Contact your service personnel.cl US Check Temp cl Toco Chk Temp clECG/IUP Chk TempMonitor: INOP tone CL transducer: tone and cyan LEDThe temperature of the transducer or its battery is critically high. If the transducer is docked on the base station, charging is interrupted. Check that the transducer is not covered and do not expose it to a heat source. Do not place the base station in a sunny window in a room without active air conditioning. The environment temperature to charge a transducer battery should not exceed 40°C/104°F. If the INOP persists, remove the transducer from patient and contact your service personnel.cl US Disconnect cl Toco Disconnect cl ECG/IUP DisconnMonitor: INOP toneCL transducer: tone and cyan LEDThe cableless transducer has lost the connection to the monitor.cl US Malfunction cl Toco Malf cl ECG/IUP MalfMonitor: INOP toneNumeric is replaced by a -?-CL transducer: tone and cyan LEDMalfunction of the transducer. Contact your service personnel.
7 Patient Alarms and INOPs137CL Fetal & Maternal Pod INOPsINOP Message Indication What to doaFHR1 Signal Loss aFHR2 Signal Loss aFHR3 Signal LossMonitor: INOP toneNumeric is replaced by a -?-INOP tone if Alarm Mode is set to All. No tone if Alarm Mode is set to INOP only.The input signal quality is not sufficient to process the measurement. Reapply the electrodes of the electrode patch.cl F&M Batt Empty !!cl F&M BattEmpty !!!cl F&M BatEmptyMonitor: INOP tone (configurable cyan, yellow, red)CL F&M Pod: LED flashes red and yellow toneThe remaining monitoring time with the CL F&M Pod is below 15 minutes. Charge the battery.cl F&M Batt IncmpMonitor: INOP toneCL F&M Pod: cyan LED and INOP toneThe battery cannot be used with the CL F&M Pod. Contact your service personnel.cl F&M Batt LowMonitor: Display onlyCL F&M Pod: LED flashes redThe remaining monitoring time with the CL F&M Pod is below 30 minutes. Charge the battery.cl F&M Batt MalfMonitor: INOP toneCL F&M Pod: cyan LEDMalfunction of the battery system (charger circuit or battery) detected (for example: persistent communication error, overvoltage, overcurrent, battery incompatible). Contact your service personnel.cl F&M Batt TempMonitor: INOP toneCL F&M Pod: cyan LEDThe temperature of the CL F&M Pod or its battery is critically high. If the Pod is docked on the base station, charging is interrupted.Check that device is not covered. Do not expose device to heat sources. If INOP persists, remove the CL F&M Pod from patient. Contact your service personnel.cl F&M Check BattMonitor: INOP toneCL F&M Pod: cyan LEDDuring charging, the battery's temperature is below 0°C (32°F), or above 45°C (113°F).During discharge, the battery's temperature is below -5°C (23°F), or above 55°C (131°F).cl F&M Chk Chrg IFMonitor: INOP toneCL F&M Pod: cyan LEDThere is an over-, or undervoltage at the charger interface. Contact your service personnel.
7 Patient Alarms and INOPs138cl F&M Chk Electr.Monitor: INOP tone without tone, if no CL F&M Pod parameter shows -?-CL F&M Pod: cyan LED• Not all electrodes have sufficient skin contact: Prepare the skin at the application site further with the abrasive pad.• One or more leads between the measurement Pod and the electrode(s) is broken: Replace the electrode patch.• Contact problem between the CL F&M Pod and the electrode patch: Reconnect the CL F&M Pod.This INOP can only occur in monitoring mode after the initial electrode impedance check has occurred.cl F&M ChkSettingsMonitor: INOP toneCL F&M Pod: cyan LEDThe CL F&M Pod settings are incompatible or corrupted. Check the settings. Contact your service personnel.cl F&M DisconnectMonitor: INOP toneCL F&M Pod: cyan LEDThe CL F&M Pod has lost the connection to the monitor. Call the patient back to the monitor. If the CL F&M Pod has still no connection, remove it from the monitor, and reassign it. If it still does not have a connection, contact your service personnel.cl F&M License ReqMonitor: INOP toneCL F&M Pod: cyan LEDThere is no valid license registered. Contact your service personnel.cl F&M MalfunctionMonitor: INOP toneCL F&M Pod: cyan LEDThe CL F&M Pod malfunctions. Contact your service personnel.cl F&M Patch DiscMonitor: INOP toneCL F&M Pod: cyan LEDThe CL F&M Pod has been disconnected from the electrode patch during monitoring mode. Reconnect the CL F&M Pod.cl F&M Patch MalfMonitor: INOP toneCL F&M Pod: cyan LED and INOP toneThe connected electrode patch cannot be identified. Either the electrode patch is malfunctioning, or the connection between the CL F&M Pod and the patch is defective.cl F&M RemoveMonitor: INOP toneCL F&M Pod: cyan LED and INOP toneThe battery temperature is too high 60°C (140°F). Remove the CL F&M Pod immediately from the patient. Contact your service personnel.INOP Message Indication What to do
7 Patient Alarms and INOPs139CL Wide Range Pod INOPsINOP Message Indication What to docl WRP Batt Empty !!cl WRP BattEmpty !!!cl WRP BatEmptyMonitor: INOP tone (configurable cyan, yellow, red)CL Wide Range Pod: Display only, yellow toneThe remaining time with the CL Wide Range Pod is below 15 minutes. Charge the battery.cl WRP Batt IncmpMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThe battery cannot be used with the CL Wide Range Pod. Contact your service personnel.cl WRP Batt LowMonitor: Display onlyCL Wide Range Pod: Display onlyThe remaining monitoring time with the CL Wide Range Pod is below 30 minutes. Charge the battery.cl WRP Batt MalfMonitor: INOP toneCL Wide Range Pod: Display onlyMalfunction of the battery system (charger circuit or battery) detected (for example: persistent communication error, overvoltage, overcurrent, battery incompatible). Contact your service personnel.cl WRP Batt TempMonitor: INOP toneCL Wide Range Pod: Display onlyThe temperature of the CL Wide Range Pod or its battery is critically high. If the Pod is docked on the base station, charging is interrupted.Check that device is not covered. Do not expose device to heat sources. If INOP persists, remove the CL Wide Range Pod from patient. Contact your service personnel.cl WRP Chk Chrg IFMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThere is an over-, or undervoltage at the charger interface. Contact your service personnel.cl WRP ChkSettingsMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThe CL Wide Range Pod settings are incompatible or corrupted. Check the settings. Contact your service personnel.cl WRP DisconnectMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThe CL Wide Range Pod has lost the WLAN/LAN connection for more than 10 seconds to the monitor.cl WRP License ReqMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThere is no valid license registered. Contact your service personnel.cl WRP MalfunctionMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThe CL Wide Range Pod is malfunctioning. Contact your service personnel.cl WRP RemoveMonitor: INOP toneCL Wide Range Pod: Display and INOP toneThe battery temperature is too high 60°C (140°F). Remove the CL Wide Range Pod immediately from the patient. Contact your service personnel.
7 Patient Alarms and INOPs140DECG and MECG INOPsINOP Message Indication What to dodFHR1 Equip Malf dFHR2 Equip Malf dFHR3 Equip MalfMonitor: INOP tone There is a problem with the DECG hardware. Contact your service personnel.dFHR1 Leads Off !! dFHR1 Leads Off !!!dFHR1 Leads OffdFHR2 Leads Off !! dFHR2 Leads Off !!!dFHR2 Leads OffdFHR3 Leads Off !! dFHR3 Leads Off !!!dFHR3 Leads OffMonitor: INOP toneNumeric is replaced by a -?-One or more DECG lead is not attached. Make sure that all required leads are attached, and no electrodes have been displaced. Check all connections are sound, and that the leg plate attachment electrode is properly attached. If the INOP persists, try using another adapter cable, or leg plate attachment electrode. If the INOP persists, contact your service personnel.dFHR1 Signal Loss dFHR2 Signal Loss dFHR3 Signal LossMonitor: INOP toneNumeric is replaced by a -?-INOP tone if Alarm Mode is set to All. No tone if Alarm Mode is set to INOP only.The input signal quality is not sufficient to process the measurement. Reapply the fetal scalp electrode.dFHR1 Unplugged dFHR2 Unplugged dFHR3 UnpluggedMonitor: INOP toneNumeric is replaced by a -?-Reconnect the DECG transducer to the monitor. Check if all connections are sound.MECG Equip MalfMonitor: INOP tone There is a problem with the MECG hardware. Contact your service personnel.MECG Leads Off !! MECG Leads Off !!! MECG Leads OffMonitor: INOP toneNumeric is replaced by a -?-One or more MECG lead is not attached. Ensure that all required leads are attached, and no electrodes have been displaced. Check if all connections are sound. If the INOP persists, try using another adapter cable. If the INOP still persists, contact your service personnel.MECG UnpluggedMonitor: INOP toneNumeric is replaced by a -?-Reconnect the MECG transducer to the monitor. Check if all connections are sound.
7 Patient Alarms and INOPs141NBP INOPsINOP Message Indication What to doCuff Not Deflated !! Cuff Not Deflat !!!Cuff Not DeflatMonitor: INOP tone (severe yellow/red INOP tone)Numeric is replaced by a -?-During this INOP, alarms cannot be paused or switched off.Remove the cuff from the patient. Make sure that the tubing is not kinked or twisted. Try restarting the measurement. You can silence the INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected.NBP Check CuffMonitor: INOP toneNumeric is replaced by a -?-Check if cuff is connected to the NBP Pod and cuff is applied to the patient; check tubing and cuff for leakage.Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected.This INOP is issued, when the maximum time for inflation is exceeded, or when there is a significant change in inflation time between two successive measurements in auto and sequence mode.NBP Cuff Overpress !! Cuff Overpress !!!Cuff OverpressMonitor: INOP tone (severe yellow/red INOP tone)Numeric is replaced by a -?-During this INOP, alarms cannot be paused or switched off.The cuff pressure exceeds the overpressure safety limits. Remove the cuff from the patient. Ensure that the tubing is not kinked or twisted, and that the correct patient category is selected.Try restarting the measurement. You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected.NBP Equip MalfMonitor: INOP toneNumeric is replaced by a -?-Remove the cuff from the patient. The noninvasive blood pressure hardware is faulty. Contact your service personnel.You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected.
7 Patient Alarms and INOPs142CL NBP Pod INOPsNBP InterruptedMonitor: INOP toneNumeric is replaced by a -?-Check the tubing and cuff for leakages or kinks. Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel.You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected. This INOP arises when the measurement needed longer than the maximum time allowed for inflation, deflation, or the total measurement.NBP Measure FailedMonitor: INOP toneNumeric is replaced by a -?-Check that you are using the correct cuff size and placement, and that the correct patient category is selected. Try restarting the measurement.You can silence this INOP, but the INOP message remains visible until the next measurement is started, or the Stop All SmartKey is selected.Check the condition and suitability of the patient for noninvasive blood pressure monitoring. Use another cuff to continue measuring.INOP Message Indication What to doINOP Message Indication What to doCheck Charger I/FMonitor: INOP toneCL NBP Pod: display messageOvervoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel.cl NBP Batt Empty !!cl NBP BattEmpty !!!cl NBP BatEmptyMonitor: INOP tone (configurable cyan, yellow, red)CL NBP Pod: display message, yellow toneThe remaining battery time of the CL NBP Pod is below 30 minutes. Charge the battery.cl NBP Batt IncompMonitor: INOP toneCL NBP Pod: display messageThe battery in use with the CL NBP Pod is incompatible. Replace it with one approved for use with the CL NBP Pod.cl NBP Batt LowMonitor: INOP toneCL NBP Pod: display messageThe remaining battery time of the CL NBP Pod is below 2 hours.cl NBP Batt MalfMonitor: INOP toneCL NBP Pod: display messageThere is a malfunction in the CL NBP Pod's battery system. Contact your service personnel.
7 Patient Alarms and INOPs143cl NBP Batt TempMonitor: INOP toneCL NBP Pod: display messageThe temperature of the battery in the CL NBP Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the Pod from the patient, and contact your service personnel.cl NBP Check BattMonitor: INOP toneCL NBP Pod: display messageThe battery in the CL NBP Pod is nearing the end of its useful life. Only 50 charge-discharge cycles remain. Contact your service personnel to replace the battery.cl NBP ChkSettingsMonitor: INOP toneCL NBP Pod: display messageIf this INOP appears and an INOP tone sounds, check the Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel.If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared.cl NBP DisconnectMonitor: INOP tone and displayCL NBP Pod: display messageThe CL NBP Pod has lost the SRR connection to the monitor.cl NBP No CradleMonitor: INOP toneCL NBP Pod: display messageThe CL NBP Pod is not in the cradle. You can silence this INOP, but the INOP message remains visible until the CL NBP Pod is inserted into the cradle, and the next measurement is started, or the Stop All SmartKey is selected.cl NBP RemoveMonitor: INOP toneCL NBP Pod: display messageThe temperature of the battery in the CL NBP Pod is too high. Remove the Cableless Measurement Device from the patient and contact service personnel.cl NBP Serv BattMonitor: INOP toneCL NBP Pod: display messageThe battery in the CL NBP Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery.NBP Check CuffMonitor: INOP toneCL NBP Pod: display messageCheck if cuff is connected to the NBP Pod and cuff is applied to the patient; check tubing and cuff for leakage.Try restarting the measurement. If the INOP occurs repeatedly, contact your service personnel. You can silence this INOP, but the INOP message remains visible until the next measurement is started or the Stop All SmartKey is selected.This INOP arises when the maximum time for inflation is exceeded or when there is a significant change in inflation time between two successive measurements in auto and sequence mode.INOP Message Indication What to do
7 Patient Alarms and INOPs144SpO2 INOPsINOP Message Indication What to doSpO Equip MalfMonitor: INOP tone There is a problem with the SpO2 hardware. Contact your service personnel.SpO ErraticMonitor: INOP toneNumeric is replaced by a -?-Check the sensor placement. Try another adapter cable and sensor. If the INOP persists, contact your service personnel.SpO Extd.UpdateMonitor: display onlyNumeric is replaced by a -?-The update period of displayed values is extended due to a noninvasive blood pressure measurement on the same limb, or an excessively noisy signal.SpO Low PerfMonitor: display onlyNumeric is replaced by a -?-Accuracy may be compromised due to very low perfusion. Stimulate circulation at sensor site. If INOP persists, change the measurement site.SpO No Pulse !! <SpO Label> No Pulse !!!<SpO Label> No PulseMonitor: INOP toneNumeric is replaced by a -?-Check the perfusion at measurement site. If necessary, stimulate circulation or change measurement site. If the INOP is due to noninvasive blood pressure measurement on the same limb, wait until the measurement is finished.SpO No SensorMonitor: INOP toneNumeric is replaced by a -?-Ensure the SpO2 sensor is connected. If the INOP persists, try another adapter cable and sensor. If you silence this INOP, the measurement will be switched off.SpO NoisySignalMonitor: INOP toneNumeric is replaced by a -?-Excessive patient movement or electrical interference is causing irregular pulse patterns. Try to reduce patient movement, or to relieve the cable strain on the sensor.SpO Poor SignalMonitor: display onlyNumeric is replaced by a -?-The signal condition of the SpO2 measurement is poor and measurement accuracy may be compromised.SpO Pulse?Monitor: INOP toneNumeric is replaced by a -?-The detectable pulsations of the SpO2 signal are outside the specified pulse rate range.SpO SearchingMonitor: display onlyNumeric unavailableSpO2 is analyzing the patient signal to derive Pulse, and SpO2 values. Please wait until the search analysis is complete.SpO Sensor MalfMonitor: INOP toneNumeric unavailableThe SpO2 sensor or adapter cable is faulty. Try another adapter cable and sensor. If the INOP persists, contact your service personnel.SpO Sensor OffMonitor: INOP toneNumeric unavailableThe SpO2 sensor is not properly applied to the patient. Apply the sensor following the instructions supplied by the manufacturer.SpO Unkn.SensorMonitor: display onlyNumeric is replaced by a -?-The connected sensor or adapter cable is not supported by the SpO2 measurement. Use only specified sensors and cables.
7 Patient Alarms and INOPs145CL SpO2 Pod INOPsSpO UpgradeMonitor: display onlyNumeric unavailableThe SpO2 measurement is currently in upgrade mode. Monitoring is not possible in this mode.SpOInterferenceMonitor: INOP toneNumeric is replaced by a -?-There is too much interference caused by a high level of ambient light, and/or electrical interference. Cover the sensor to minimize ambient light. If the INOP persists, ensure that the sensor cable is not damaged, or positioned too close to power cables.INOP Message Indication What to doINOP Message Indication What to doCheck Charger I/FMonitor: INOP toneCL SpO2 Pod: display messageOvervoltage or undervoltage detected at the charger interface. Clean contacts of charger interface at Cableless Measurement Device and charging station. If the INOP persists, contact your service personnel.cl SpO Batt Empty !!cl SpO BatEmpty !!!cl SpO BtEmptyMonitor: INOP tone (configurable cyan, yellow, red)CL SpO2 Pod: display message, yellow toneThe remaining battery time of the CL SpO2 Pod is below 30 minutes. Charge the battery.cl SpO Batt IncmpMonitor: INOP toneCL SpO2 Pod: display messageThe battery in use with the CL SpO2 Pod is incompatible. Replace it with one approved for use with the CL SpO2 Pod.cl SpO Batt LowMonitor: INOP toneCL SpO2 Pod: display messageThe remaining battery time of the CL SpO2 Pod is below 2 hours.cl SpO Batt MalfMonitor: INOP toneCL SpO2 Pod: display messageThere is a malfunction in the CL SpO2 Pod's battery system. Contact your service personnel.cl SpO Batt TempMonitor: INOP toneCL SpO2 Pod: display messageThe temperature of the battery in the CL SpO2 Pod is critically high. Check that the Pod is not covered or exposed to a heat source. If the INOP persists, remove the CL Pod from the patient, and contact your service personnel.cl SpO Check BattMonitor: INOP toneCL SpO2 Pod: display messageThe battery in the CL SpO2 Pod is nearing the end of its useful life. Only 50 charge-discharge cycles remain. Contact your service personnel to replace the battery.
7 Patient Alarms and INOPs146Tympanic Temperature INOPscl SpO Chk SettMonitor: INOP toneCL SpO2 Pod: display messageIf this INOP appears and an INOP tone sounds, check the Cableless Measurement Device and patient settings before you resume making measurements. If the settings are unexpected, there may be a problem with the Cableless Measurement Device software. Contact your service personnel.If this INOP is acknowledged at the Cableless Measurement Device, it is cleared. If it is silenced remotely, only the tone is cleared.cl SpO DisconnectMonitor: INOP toneCL SpO2 Pod: INOP tone and display messageThe CL SpO2 Pod has lost the SRR connection to the monitor.cl SpO No CradleMonitor: INOP toneCL SpO2 Pod: display messageThe CL SpO2 Pod is not in its cradle.cl SpO RemoveMonitor: INOP toneCL SpO2 Pod: display messageThe temperature of the battery in the CL SpO2 Pod is too high. Remove the CL SpO2 Pod from the patient and contact service personnel.cl SpO Serv BattMonitor: INOP toneCL SpO2 Pod: display messageThe battery in the CL SpO2 Pod has reached the end of its useful life. It can no longer be charged. Contact your service personnel to replace the battery.INOP Message Indication What to doINOP Message Indication What to do<iTemp Label> CalRequiredMonitor: INOP tone The thermometer requires calibration. Contact your service personnel.<iTemp Label> Incompat.Monitor: INOP toneNumeric is replaced by a -?-The thermometer firmware is not supported by the monitor software.<iTemp Label> MalfunctionMonitor: INOP toneNumeric is replaced by a -?-The thermometer or the interface board is defective. Check the thermometer on another monitor - if the same INOP occurs, replace the thermometer. If not, connect another thermometer to this monitor. If the problem persists, the interface board has a problem. Contact your service personnel.<iTemp Label> Meas FailedMonitor: INOP toneNumeric is replaced by a -?-The ambient temperature is out of range. If the ambient temperature is within the valid range, check the thermometer. Try picking up a new probe cover. If the problem persists replace the thermometer and contact your service personnel.<iTemp Label> OverrangeMonitor: INOP toneNumeric is replaced by a -?-The measured temperature is out of range. If the temperature is within the valid range, check with another thermometer.
81478Admitting and DischargingThe fetal monitor can store basic patient demographic information used to identify patients.Admit/Discharge on the MonitorThis section describes how you admit and discharge patients when using the monitor as a stand-alone device (that is, when not used with an obstetrical information and surveillance system such as OB TraceVue/IntelliSpace Perinatal).Admitting a PatientThe fetal monitor displays physiological data as soon as a patient is connected. This lets you monitor a patient who is not yet admitted. It is however important to admit patients properly so that you can identify your patient on recordings.Use the Patient Demographics window and its associated pop-up keys to admit and discharge patients.To admit a patient:1Select the patient name field or select the Patient Demogr. SmartKey to open the Patient Demographics window.2Clear any previous patient data by selecting Dischrge Patient and then Confirm.If you do not discharge the previous patient, you will not be able to distinguish data from the previous and current patients on the recording.3Select Admit Patient.4Enter the patient information: select each field and use the on-screen keyboard.If a conventional keyboard is connected to the monitor, you can use this to enter patient information:–Last Name: Enter the patient's last name (family name), for example Doe.–First Name: Enter the patient's first name, for example Jane.–MRN: Enter the patient's medical record number (MRN), for example 12345678. Depending on your configuration this field may be labeled differently e.g. Record ID, Lifetime ID, Account Number, Serial Number, or SSN.–Gestational Age: Enter the gestational age of the pregnancy. Enter one numeric for the week (0-50) and one numeric for the day (0-6).–Date of Birth: Enter the patient's date of birth.5Select Confirm. The patient status changes to admitted. If the recorder is running, the recorder stops and immediately restarts to annotate the new patient data.
8 Admitting and Discharging148Quick Admitting a PatientUse Quick Admit to quickly admit a patient using only a limited set of demographic data.1Select the Quick Admit SmartKey.2Enter the required data (ID fields or last name depending on configuration) with the keyboard or a barcode scanner.3Select Enter.4In the confirmation window, select Confirm to stop monitoring for the previous patient.Complete the rest of the demographic details as soon as possible to fully identify the patient on the network, on the monitor, and on printed reports. To complete the details, open the Patient Demographics window and complete all required fields.Editing Patient InformationTo edit the patient information after a patient has been admitted, select the patient name field on the main screen of the fetal monitor to open the Patient Demographics window, and enter the required changes.Discharging a PatientYou should always perform a discharge even if your previous patient was not admitted. A discharge:– clears the information in the Patient Demographics window.– resets all monitor settings to the settings defined in the User Defaults.– advances the paper automatically if the recorder is running.– stops the fetal recorder.When a patient is discharged from the monitor, all patient demographic data is deleted (trace data is not affected).Depending on your configuration, monitoring for a patient may end automatically when the fetal monitor has been powered off, or is in Standby mode for a set time.To discharge a patient:1Select the patient name field to display the Patient Demographics window and associated pop-up keys.2Select the pop-up key for Dischrge Patient.3Select Confirm to discharge the patient.CAUTIONIn order to ensure that the settings are reset to User Defaults for a new patient, always discharge the previous patient from the fetal monitor.NOTEIn order to ensure a continuous record, it is recommended to discharge the patient at the monitor before performing a new patient admission in OB TraceVue/IntelliSpace Perinatal.
8 Admitting and Discharging149New Patient CheckThe fetal monitor can be configured to ask you in certain situations:• after a specified power-off period• after a specified standby periodwhether a new patient is now being monitored. The pop-up window is entitled Is this a New Patient?. The monitor offers a Yes key, to discharge the previous patient and begin monitoring a new patient, and a No key, to continue monitoring with the current patient data and settings.The time periods for the two conditions can be configured independently.OB TraceVue/IntelliSpace PerinatalWhen the monitor is connected to an OB TraceVue/IntelliSpace Perinatal system over a LAN connection, it has the control over patient demographic data. All patient and location-related data visible on the monitor is set, overwritten, or updated by the OB TraceVue/IntelliSpace Perinatal system. In the Patient Demographics window, a padlock symbol before the patient identification fields indicates the locked state. The locked state prevents the reuse of the monitor for another patient, until the current patient is discharged, and the monitor is freed through the OB TraceVue/IntelliSpace Perinatal system. Locked fields remain locked when system connectivity is lost, until the monitor is freed by discharging the patient. See the OB TraceVue/IntelliSpace Perinatal Instructions for Use for details.Transferring a PatientWhen you are transferring a patient from one bed to another, both the monitor from which you are transferring her and the monitor to which you are transferring her must be switched on and connected to the OB TraceVue/IntelliSpace Perinatal network during the patient transfer.
8 Admitting and Discharging150OB TraceVue/IntelliSpace Perinatal via RS232In contrast to a LAN connection, when the monitor is connected to an OB TraceVue/IntelliSpace Perinatal system over an RS232 connection, the OB TraceVue/IntelliSpace Perinatal system does not have full control over the monitor's patient admission and discharge functions.Depending on how OB TraceVue/IntelliSpace Perinatal is configured, either the Last Name, First Name, and the bed label, or just the bed label alone, are taken from the OB TraceVue/IntelliSpace Perinatal system. See the OB TraceVue/IntelliSpace Perinatal Instructions for Use for details.
91519Non-Stress Test TimerThe non-stress test (NST) timer shows the elapsed time for the non-stress test. The timer counts up to the time you set for the NST.Setting NST Autostart/AutostopYou can set the recorder so that it starts automatically (NST Autostart) when the NST timer is started, and stops automatically (NST Autostop) when the NST is complete (when the set run time has elapsed). As default, NST Autostart is On, and NST Autostop is Off.Viewing the NST TimerYou can configure the timer notification symbol, (the NST label), a progress bar and the elapsed time to be displayed in the top left-hand corner of the screen. By default, the NST timer is not displayed on the screen.Alternatively, you can view the timer in the Timers window.To open the Timers window:Either• Press the Timer SmartKey.Or• Access the NST pop-up keys (see “Accessing the NST Setup Pop-up Keys” on page 152), and press the Timers key.Timer Expiry NotificationWhen the timer expires, the color changes from blue to green, you hear a single tone, and a message appears in the status line on the main screen.The volume of the tone can be set in Configuration Mode.
9 Non-Stress Test Timer152Accessing the NST Setup Pop-up KeysYou control and set up the NST timer (for example, start, stop, or clear the timer, and set the run time) using a selection of pop-up keys that you access via any one of three possible routes:• Via the Timer SmartKey (Route 1)• Via the Main Setup SmartKey (Route 2)• Via the NST display area at the top left-hand corner of the screen (Route 3). When you touch the NST display area, the NST pop-up keys become available at the bottom of the screen.Via the Timer SmartKey (Route 1)Press the Timer SmartKey. The Timers window opens, and the pop-up keys for controlling/setting up the NST timer appear (see “Pop-up Keys for NST Timer Setup” on page 152).Via the Main Setup SmartKey (Route 2)1Enter the Main Setup menu using the SmartKey.2Select NST to enter the Setup NST menu. At the same time, the pop-up keys for setting up the NST timer appear (see “Pop-up Keys for NST Timer Setup” on page 152).Via the NST Display Area (Route 3)Select the NST display area at the top left-hand corner of the screen (when so configured). The pop-up keys for controlling/setting up the NST timer become available at the bottom of the screen (see “Pop-up Keys for NST Timer Setup” on page 152).Pop-up Keys for NST Timer SetupRuntimeThe run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the run time.Run TimeThe run time can be set from 10 to 60 minutes. See the Configuration Guide for details how to set the run time.Pop-Up Keys Selecting this pop-up key lets you: CommentsStartStart the timer.StopStop the timer, allowing either restarting after a pause (Start) or clearing (Clear key).Setup NSTEnter the Setup NST menu. From here you can set the run time.This pop-up key is not available with Route 2, as the Setup NST menu is already open.TimerReturn to the Timers window. This pop-up key is not available with Route 1, as the Timers window is already open.
1015310Non-Stress Test ReportIt is generally accepted that a non stress test (NST) allows you to assess fetal well-being. The monitor's NST report process uses fetal ultrasound (but not DECG) heart rate traces and the Maternal Toco trace to generate a printed report when criteria are met and it is an indication of the fetal well-being. The American term Non Stress Test (NST) is used for antepartum testing. The interpretation algorithm and rule set are equivalent to those implemented in OB TraceVue Revision G.xx or IntelliSpace Perinatal Revision H.xx and higher, and are based on the 2008 NICHD guidelines.An NST report is a diagnostic aid, but it does not replace the clinician’s judgment. The interpretation and the appropriate clinical response remain with the clinician.A fetus normally produces characteristic heart rate patterns. Average baseline variability and acceleration of the FHR in response to fetal movement are considered reassuring signs. This test does not take into account any form of external fetal stimulation.For every active ultrasound fetal heart rate measurement, one NST report can reside in the monitor’s memory. The reports are cleared when you discharge a patient and when you start a new NST report.When the NST Report option is available and the NST Report feature is "on", the NST status for all available ultrasound fetal heart rate measurements are displayed on the screen.The minimum displayed information is:• NST identification (by FHR number: 1, 2, 3)• Current NST status (by color: inverse for "not started yet", white for "running", yellow for "stopped", green for "finished")Setting Up an NST ReportTo set up NST Report functionality:1Enter the Main Setup menu and select the NST Report.2Or select the NST Report SmartKey.3Press the Setup pop-up key.
10 Non-Stress Test Report1544Set your configuration options.Select from:•NST Analysis choose from On or Off.This switches the report feature on or off. This is linked to the NST timer. Both must be set to On for the NST report to function.•Report Recording choose from:–Manual - press the Record Report pop-up key to trigger a manual request.–After Recorder Stop - report is recorded as soon as recorder becomes idle.–Immediately - if a realtime recording is running, the monitor pauses it. The recording is continued after the report has been recorded.Average short term variability (STV) value is documented in [bpm] and [ms] if STV is configured as part of the NST Report. This parameter is not considered as reassuring criteria.NST Report Status WindowThe NST Report window displays a detailed overview of the current NST status for any available ultrasound fetal heart rate measurement. You can see:• NST Status - whether it is ready, ongoing, or the time and date at which it was stopped, or at which it was finished.• Elapsed time - the time that has elapsed since the NST began.• Accelerations - the number of FHR accelerations detected so far.• Baseline - the average baseline value.• Variability - the average variability value.• Short Term Variability - the current short term variability (STV) value.• Decelerations - the number of FHR decelerations detected so far.• FHR Availability - current statistical FHR availability value.• Sinusoidal - the current status of sinusoidal rhythm detection.For criteria not yet met, a white arrow symbol marks the overall status on the top line, and also appears against every criterion not yet met. A yellow symbol indicates detection of severe or prolonged decelerations.The pop-up keys let you perform the following actions:•FHR1, FHR2, FHR3 - switch to the window showing the current NST status for the fetal heart rate.•Record Report - print the NST Report on paper.•Record Trace - record the trace episode that belongs to the current report. Depending on device usage, the trace recording might be incomplete.•Setup - open the Setup NST Report window.
10 Non-Stress Test Report155Example NST ReportField Field ContentReport Title, with FHR label and dateNST Report for FHR1 on 12 Oct. 2009Product Information Product DE53102345 G.01.70, OB A.04.24,Toco DE52401090, FHR1 DE00002345 A.05.26Patient Information Rogers, AliceAge: 27Gestational Age: Week 34, Day 5Start time, end time, Elapsed time, configured runtime Time: 11:34 – 12:06Elapsed time: 32 minRun time: 20 minOverall one-line NST result summaryNST Criteria*: not metTitle Trace Interpretation SummaryResult Accelerations Accelerations: 2at: 11:59 12:02Result: Contractions Contractions: 3at: 11:57 12:00 12:04Result: Baseline and VariabilityBaseline: 125 bpm (Range: 118-129 bpm)Variability: 23 bpm (Range: 20-24 bpm)Statistics: FHR availability FHR available: 95%Result: Decelerations Decelerations: 1at: 11:58severeprolongedResult:Sinusoidal Rhythm detectedSinusoidal: No
10 Non-Stress Test Report156Result: Decelerations before Reporting PeriodEvents before Reporting Period:Decelerations: 1at: 11:38severeprolongedThis field is enabled if there were decelerations between the start of NST and the start of the reporting period.Guideline/Criteria Information(*) Interpretation criteria based on guideline "NICHD 2008, v01"User-defined criteria for CTG tracing:• valid FHR for 90% of reporting period• baseline heart rate between 120 bpm and 160 bpm• at least 2 accelerations in 10 min• not more than 1 decelerations• moderate baseline variability (6-25 bpm)Additional criteria:• no severe or prolonged decelerations• no sinusoidal pattern in reporting periodField Field Content
10 Non-Stress Test Report157NST CriteriaThe patient is monitored for a user-definable period of time (10-60 minutes in steps of 5 minutes). The test is considered reassuring when the following criteria are met:• The fetal heart rate is valid at least 90% (this is configurable) of the specified time span.• The FHR features a user-defined minimum number of accelerations.• The FHR features a user-defined maximum number of tolerated decelerations, and does not include severe or prolonged decelerations, which are never tolerated.• The average baseline fetal heart rate lies within the user-defined limits for low heart rate and high heart rate over the whole time span.• The FHR exhibits a moderate variability (user-defined) for the specified time span.An NST Report is generated when the reassuring criteria are met the first time in the current monitoring phase. When performing NST with twins or triplets, a separate NST Report is generated for each fetus.After the reassurance criteria have been met, the clinician can print the NST Report and then turn the fetal monitor off, or may continue fetal monitoring and print the report at any time.Non-Reassuring ReportIf the reassurance criteria are not met when the test has run for 90 minutes, or if you stop anytime during the 90 minute period, then the test is stopped, and a report is generated stating the reassurance criteria have not been met.Nonreactive NST TestIf a nonreactive test occurs, and you then use acoustic stimulation, you must exercise caution in interpreting the resulting traces, as artificial stimulation is not taken into account when calculating test results.
10 Non-Stress Test Report158
1115911Cross-Channel Verification (CCV)The cross-channel verification helps to reduce the possibility of misidentification of the maternal heart rate for the fetal heart rate. It does this by comparing the measured fetal heart rate to the maternal heart rate. If there are multiple fetal rates, they are also compared with each other and the maternal heart rate.Misidentification of Heart RatesFHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded fetal heart rate (see “Confirm Fetal Life Before Using the Monitor” on page 10).To reduce the possibility of mistaking the maternal HR or pulse for FHR, or FHR1 for FHR2 or FHR3, it is recommended that you monitor both maternal HR/pulse and the heart rates of all fetuses (see “Monitoring FHR and FMP Using Ultrasound” on page 165, “Monitoring Twin FHRs” on page 183, “Monitoring Triple FHRs” on page 191, and “Monitoring Maternal Heart / Pulse Rate” on page 221).Here are some examples where the maternal HR can be misidentified as the FHR, or one FHR for another FHR (twins/triplets).When using an ultrasound transducer:– It is possible to pick up maternal signal sources, such as the maternal heart, aorta, or other large vessels. Especially if the recorded maternal HR, and any other artifact is over 100 bpm.– It is possible to pick up the same fetal heart rate simultaneously with multiple transducers.NOTEWhen an ultrasound transducer is connected to the monitor, but not applied to the patient, the measurement may generate unexpected intermittent FHR readings.
11 Cross-Channel Verification (CCV)160When Fetal Movement Profile (FMP) is enabled:The FMP annotations on a fetal trace alone may not always indicate that the fetus is alive. For example, FMP annotations in the absence of fetal life may be a result of:• Movement of the deceased fetus during or following maternal movement.• Movement of the deceased fetus during or following manual palpation of fetal position (especially if the pressure applied is too forceful).• Movement of the ultrasound transducer.When using a scalp electrode (DECG):• Electrical impulses from the maternal heart can be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source.Cross-Channel Verification FunctionalityThe cross-channel verification functionality (CCV) of the fetal monitors compares all monitored heart rates (maternal and fetal), and indicates automatically whether any two channels are picking up the same signal, or monitoring similar values.If the fetal monitor detects that any channels have the same or similar values, the Coincidence INOP is issued with an INOP tone that can have a configurable delay. In addition, yellow question marks appear next to the numerics on the touchscreen that have the same or similar values. On the recording trace there is also a question mark from the point where recorded traces continuously overlap.Visual Aids for CCV DetectionCoincidence INOP appears on the screen of the fetal monitor.Question mark appears on the screen of the fetal monitor next to the numerics that show the same or similar values.Question mark recorded on the trace from the point where two measured values coincide.
11 Cross-Channel Verification (CCV)161Overview of Cross-Channel ComparisonsMeasurements from TransducersMeasurement Comparison Done by the Fetal Monitor for Cross-Channel Verification* dFHR and aFHR always replace one of the fetal channels (1,2, or 3) and cannot be compared to the channel it replaces. If you monitor for example twins with two ultrasound transducers, you see the numerics FHR1 and FHR2 at the monitor. If you decide to replace the ultrasound transducer for FHR2 with a fetal scalp electrode, the dFHR numeric is then shown as dFHR2.Measurement TransducerFHR (US) From Ultrasound or CL Ultrasound transducerdFHR (DECG) From a fetal scalp electrodeaFHR (abdom. ECG) From the CL Fetal & Maternal PodPulse (Toco) From Toco MP, or CL Toco+ MP transducerPulse (SpO2) From SpO2 or CL SpO2 PodHR (MECG) From MECG electrodesaHR (abdom. ECG) From the CL Fetal & Maternal PodFHR1 (US) FHR2 (US) FHR3 (US) dFHR (DECG)* aFHR* (ECG)FHR1 (US)FHR2 (US)FHR3 (US)dFHR (DECG)*aFHR (abdom. ECG)Pulse (Toco)Pulse (SpO2)HR (MECG)aHR (abdom. ECG)
11 Cross-Channel Verification (CCV)162Coincidence ExamplesCoincidence of Maternal Pulse and FHRWhen the maternal pulse and FHR are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case maternal pulse and FHR). Often the signal loss or coincidence happens because the fetal or maternal movement displaced the ultrasound transducer, and a repositioning of the transducer is necessary.Pulse DelaySpO2 pulse rate traces have an averaging calculation of approximately 10 seconds and an overall delay of approximately 12 seconds (depending on recorder speed). This differs from a non-averaged beat-to-beat MECG heart rate trace or an ultrasound heart rate trace calculation (having switched to the maternal HR) with no significant delay. Note that Maternal Pulse from Toco has an averaging of 4 seconds and an overall delay of between 6 and 8 seconds.1Coincidence INOP2Coincidence question mark above FHR13Coincidence question mark above pulse from Toco MP
11 Cross-Channel Verification (CCV)163The coincidence question mark is also printed on the trace paper next to the corresponding FHR and maternal pulse.Coincidence of Twins/Triplets FHRsWhen both FHR1 and FHR2 are being monitored, and the measured values are very similar or the same, the coincidence question mark is displayed on the monitor’s screen above both of the corresponding numerics (in this case FHR1 and FHR2).1Printed coincidence question mark on trace2Fetal heart rate trace from Ultrasound3Maternal pulse trace from SpO21Coincidence INOP2Coincidence question mark above FHR13Coincidence question mark above FHR2
11 Cross-Channel Verification (CCV)164The coincidence question mark is also printed on the trace paper next to FHR1 and FHR2.Recommended Actions for Coincidence INOP1Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope.2Manual determination of the maternal pulse and comparison with the fetal heart rate sound signals from the loudspeaker.3Reposition the transducer, or ensure that the fetal scalp electrode is placed correctly, until you receive a clear signal and the monitor is no longer issuing the Coincidence INOP.4In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 or the CL SpO2 Pod instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco MP).5If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography.1Printed coincidence question mark on trace2FHR1 and FHR2 traces
1216512Monitoring FHR and FMP Using UltrasoundTo monitor a single FHR externally, you use an ultrasound transducer attached to a belt around the mother's abdomen. The ultrasound transducer directs a low-energy ultrasound beam towards the fetal heart and detects the reflected signal. Your monitor can also detect fetal movements and print the fetal movement profile (FMP) on the trace. Monitoring using ultrasound is recommended from the 25th week of gestation for non-stress testing or routine fetal monitoring.WARNINGPerforming ultrasound imaging or Doppler flow measurements together with ultrasound fetal monitoring may cause false FHR readings, and the trace recording may deteriorate.Technical DescriptionFetal monitors use the ultrasound Doppler method for externally monitoring the fetal heart rate. Using the Doppler method, the transducer (in transmitter mode) sends sound waves into the body which are then reflected by different tissues. These reflections (Doppler echoes) are picked up by the transducer (in listening mode). These Doppler echoes are amplified and sent to the monitor’s speaker through which the fetal heart signal can be heard. In parallel the Doppler echoes are processed through an autocorrelation algorithm to determine the fetal heart rate (FHR). The FHR is displayed on the monitor’s numeric display and on the recorded trace.Properly representing the fetal heart rate using a device that derives heartbeats from motion is a formidable task and the limitations of the technology will be discussed shortly. Basic fetal cardiac physiology may contribute to difficulties in obtaining a reliable ultrasound signal.A heart rate pattern of a fetus is capable of extraordinary variation, ranging from a stable pattern with minimal variation while the fetus is “asleep” to robust accelerations of 40-60 bpm above baseline rate over a few seconds, or exaggerated variability when the fetus is active. Decelerations of the rate 60-80 bpm below baseline may develop even more abruptly than the accelerations. Beat-to-beat arrhythmias may further exaggerate the amount of “variability” and can be seen at the bottom of variable decelerations, or in the presence of fetal breathing movements which also tend to lower the fetal heart rate. The recognition of these normal variations in fetal heart rate patterns will greatly assist in the separation of genuine fetal information from the artifact.
12 Monitoring FHR and FMP Using Ultrasound166Limitations of the TechnologyAll tissues moving towards or away from the transducer generate Doppler echoes. Therefore, the resulting signal that is provided to the monitor’s speaker, and for further fetal heart signal processing, can contain components of the beating fetal heart wall or valves, fetal movements, fetal breathing or hiccup, maternal movements such as breathing or position changes, and pulsating maternal arteries.The fetal heart signal processing uses an autocorrelation algorithm to obtain periodic events such as heart beats. If the signal is erratic such as from a fetal arrhythmia, the ultrasound device may have trouble tracking the abrupt changes, and may misrepresent the true FHR pattern. Signals such as those from moving fetal limbs are usually very strong, thereby masking the fetal heart signal. During prolonged movements where the fetal heart signal is masked, the FHR appears blank on the numeric display and as a gap on the recorded trace. Fetal position changes, maternal position changes, or uterine contractions can move the fetal heart partly or fully out of the ultrasound beam resulting in signal loss, or even picking up Doppler echoes from pulsating maternal arteries. In these cases a maternal heart rate or sometimes even a rate resulting from the mixture of fetal and maternal signals may be displayed on the monitor’s numeric display and on the recorded trace.In contrast to the timely well-defined R-peak of an ECG signal obtained with a fetal scalp electrode, the ultrasound Doppler signal from a fetal heart consists of multiple components from atria (diastole), ventricles (systole), valves, and pulsating arteries. These components vary depending on fetal and transducer position and angle, and are further modulated by factors such as fetal or maternal breathing. These effects may produce what is called “artifact”. Optimal transducer positioning therefore is key to minimizing these effects and thereby minimizing artifact.Misidentification of Maternal HR as FHRFHR detection by the monitor may not always indicate that the fetus is alive. Confirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the recorded heart rate (see “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159).What You Need• Ultrasound transducer• Toco MP or CL Toco+ MP transducer• Ultrasound gel• Transducer belt (and optional butterfly belt clip, if applicable)
12 Monitoring FHR and FMP Using Ultrasound167Cableless Monitoring - Important ConsiderationsWhen using an Avalon CL or Avalon CTS Fetal Transducer system with your monitor, note the following:Refer to “Cableless Status Indication” on page 95 for general rules regarding the use of cableless transducers from an Avalon CL or Avalon CTS Cableless Fetal Transducer system.CAUTIONNever use ultrasound transducers connected to more than one fetal monitor on the same patient.• When using an Avalon CL or Avalon CTS you should be aware that FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) on the fetal monitor (Fetal Movement Off) if the mother is walking. See also “Fetal Movement Profile” on page 170.• With the Avalon CL Transducer System, you can monitor twins and triplets with cableless transducers. The Avalon CTS System does not have this option.The wireless symbol appears next to the measurement label, indicating that the measurement is being made by a cableless transducer.1FHR12Toco parameter
12 Monitoring FHR and FMP Using Ultrasound168WARNING• During ambulant FHR monitoring, the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring. The frequency of the patient's walk may be detected, and mistaken for an FHR signal.• Check the mother’s pulse periodically during monitoring and compare this with the FHR signal. Beware of mistaking a “doubled” maternal heart rate for FHR. If a fetus is dead, there is a risk that the maternal heart rate is monitored and misinterpreted as the fetal heart rate. Therefore, the simultaneous monitoring of maternal heart rate (preferably, the maternal ECG) and the fetal heart rate is encouraged.• Do not interpret maternal movements as fetal movements.• Artifacts: FMP artifacts are generated during fetal heart rate searching by changing the transducer position, therefore the fetal monitors enable the FMP only after detecting a valid heart rate signal for several seconds. FMP is not recommended when the mother is likely to move, and you should disable Fetal Movement Profile (FMP) at the fetal monitor (Fetal Movement Off) if the mother is walking.• Gaps in maternal heart rate detection can occur:– if the transducer is not correctly positioned.– due to the pulsation of uterine blood vessels.– if the fetus moves.Preparing to MonitorPrepare for ultrasound monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1Determine fetal position.2Fasten the belt around the patient.3Switch on the monitor and the recorder.4Connect the transducer to a free socket. The signal quality indicator for the heart rate initially displays an invalid signal.5Apply a thin layer of ultrasound gel to the underside of the transducer.CAUTIONUsing ultrasound gel not approved by Philips may reduce signal quality and may damage the transducer. This type of damage is not covered by warranty.1Place the transducer on the abdomen, if possible over the fetal back or below the level of the umbilicus in a full-term pregnancy of cephalic presentation, or above the level of the umbilicus in a full-term pregnancy of breech presentation. Work the transducer in a circular motion to ensure the gel layer makes good contact.2When the transducer is connected correctly and you receive a good signal, the signal quality indicator should be filled out. If an inadequate signal is produced, the signal quality indicator will indicate a poor signal, and no numeric will appear on the screen.
12 Monitoring FHR and FMP Using Ultrasound1693Adjust the audio volume of the monitor's loudspeaker to a clearly audible level, while moving the transducer over the abdomen. When you have a good signal, secure the transducer in position below the belt.WARNINGPeriodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. Do not mistake a doubled or elevated maternal HR for FHR.The ultrasound transducer may warm slightly (less than 1°C/1.8°F above ambient temperature) when applied to the patient. When not applied, the transducer can reach a maximum temperature of 44°C/112.2°F at an air temperature of 40°C/104°F.Selecting Fetal Heart SoundYou can listen to the fetal heart sound from one ultrasound transducer at a time. When the fetal heart sound is selected for an FHR channel, you see the audio source symbol next to the FHR numeric label for that channel.To select the audio source for an FHR channel:1Enter the Setup FHR1 menu for the channel you want to hear (FHR1 used as an example).2Press Select Audio. It may take a few seconds for the audio source symbol to appear.1FHR12Audio source symbol
12 Monitoring FHR and FMP Using Ultrasound170Changing the Fetal Heart Sound VolumeThe FHR volume symbol at the top right of the Fetal Heart Sound Volume window gives you an indication of the current volume. To change the volume:1Select the volume symbol. The volume scale pops up.2Select the required volume from the volume scale.Fetal Movement ProfileThe Fetal Movement Profile (FMP) parameter detects fetal movements with an ultrasound transducer connected to the monitor. Only the fetus monitored on the FHR1 channel is monitored for FMP.Once you have enabled FMP (see “Switching FMP On and Off” on page 171), it is triggered automatically whenever:• You connect an ultrasound transducer.• A patient is discharged.When FMP is enabled, the ultrasound transducer detects most fetal body movements. Eye movements are not detected, and movement of the feet and hands may not be detected. Positioning or repositioning of the transducer is recorded as fetal movement. Maternal movement, excessive fetal breathing, or fetal hiccups may also be recorded as fetal movement (also in case of fetal demise or during the second stage of labor). You can mark these artifacts on the trace paper using either the remote event marker, or the event marker key as described in “Marking an Event” on page 60. FMP should be interpreted with care, or disabled when the patient is ambulating or during the second stage of labor. Ignore these movements when you interpret the FMP. When monitoring twins or triplets, only the fetus monitored on the FHR1 channel is monitored for movement, but be aware that movements recorded for FHR1 may also be caused by movement of the second or third fetus.The fetal movement profile (FMP) appears as "activity blocks" along the top of the Toco scale, the length of each block showing the duration of the activity.1Fetal Heart Sound Volume
12 Monitoring FHR and FMP Using Ultrasound171FMP StatisticsFMP statistics are printed every ten minutes.The FMP detection activates after about half a minute of steady heart rate signals (signal indicator half-full, or full) to minimize transducer positioning artifact. You will notice this deliberate delay:• When a new patient is admitted. A patient discharge restarts the FMP statistics from zero.• When you connect an ultrasound transducer.Switching FMP On and OffYou can switch FMP on and off from any FHR channel. For example, to set it from the FHR1 channel:1Enter the Setup FHR1 menu.2Select Fetal Movement to switch between On and Off.3Return to the main screen.1FMP enabled2FMP started hereAIndication of current fetal movementBThe FMP statistics are presented as two percentage figures:The first figure shows the percentage of detected fetal movements in the previous ten minutes.CThe second figure shows the percentage of detected fetal movements since the start of recording.To mark the start of the FMP statistic, FMP is printed on the paper with an arrow.
12 Monitoring FHR and FMP Using Ultrasound172TroubleshootingProblem Possible Causes SolutionsErratic traceErratic displayFetal arrhythmia Consider monitoring FHR using DECG after the rupture of membranes.Obese patientTransducer position not optimal Reposition transducer until signal quality indicator shows a good signal (at least half-full).Belt loose Tighten beltToo much gel Remove excessVery active fetus -Insufficient gel Use enough gel to ensure the transducer makes good contact with the mother's skin.Signal quality indicator is continuously poorTransducer position not optimal Reposition transducer until signal quality indicator shows a good signal (at least half-full).FHR less than 50 bpm (and the FHR is audible)If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm.Questionable FHR Recording maternal HR by mistake Reposition transducerConfirm fetal lifeRecording periodic signals when the transducer is not applied to the patientDisconnect all NON-USED ultrasound transducers, as continuous, regular mechanical, or electromagnetic influences can result in an artificial trace.Recorded FHR appears to be suspiciously higher, or suspiciously lower, than real FHR. In very rare cases, half- or double-counting of the FHR can occur.If you have reason to question the validity of the recorded FHR, always verify FHR by independent means (by auscultation, for example). Measure maternal pulse by independent means.FHR not recorded FHR is less than 50 bpm or over 240 bpm If membranes are ruptured, using a fetal scalp electrode (FM30 and FM50 only) allows measurement of FHR down to 30 bpm.If FHR is outside of the specified range, verify FHR by independent means.FHR1 Equip Malf or FHR2 Equip Malf or FHR3 Equip Malf INOP displayed. See “Patient Alarms and INOPs” on page 129.FHR1 Signal Loss or FHR2 Signal Loss or FHR3 Signal Loss INOP displayed.FHR1 Unplugged or FHR2 Unplugged or FHR3 Unplugged INOP displayed.If you suspect the transducer is malfunctioning Test the transducer.
12 Monitoring FHR and FMP Using Ultrasound173Testing Ultrasound TransducersIf any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel.If the second transducer also fails the tests, contact your service personnel.You can test all ultrasound transducers, including the cableless ones, as described above.Additional InformationArtifact in Fetal Heart Rate MeasurementHow to detect it and reduce its occurrence using the Avalon Fetal MonitorThe ultrasound derived FHR measurement technique in Avalon fetal monitors, like all other ultrasound fetal monitors’ FHR measurement techniques, has limitations that can lead to misrepresentation of the fetal heart rate pattern and potential misinterpretation of the fetal condition.An incorrect interpretation of the trace may lead to either unnecessary interventions, or to failure to detect fetal distress, and the need for intervention. Thus, the on-going evaluation of the recorded trace requires regular confirmation that the trace represents the true FHR. Specific situations requiring such confirmation include the following:• After starting a measurement or changing a transducer• After maternal position changes, for example during pushing with contractions• When the tracing shows abrupt changes in baseline rate, variability, or pattern (decelerations to accelerations) especially in the second stage of labor• When the baseline maternal heart rate is within about 15 bpm of the FHRTo test an ultrasound transducer:1Switch on the monitor and the recorder.2Connect the transducer to the fetal monitor.3Select the fetal heart sound for this channel.4Increase the loudspeaker volume to an audible level.5Holding the transducer in one hand, move your other hand repeatedly towards and then away from the surface.6Check that a noise is heard from the loudspeaker.
12 Monitoring FHR and FMP Using Ultrasound174• When you are unable to determine a baseline rate, and variability occurs between consecutive contractionsThere are several ways to verify the source and/or accuracy of the recorded fetal heart rate pattern. These include:Verification of the FHR with:• An obstetric stethoscope• Ultrasound imaging• A fetal scalp electrodeVerification of the maternal heart rate:• Using pulse oximetry - for a maternal heart rate pattern displayed simultaneously with the FHR (Cross-Channel Verification (CCV) feature)• Using Maternal ECG - for a maternal heart rate pattern displayed simultaneously with the FHR (CCV feature)• Manual determination of the maternal pulseWhenever possible measure the maternal pulse rate to make use of the monitor’s Cross-Channel Verification (CCV) feature, especially during the second stage of labor, or when the maternal pulse is elevated over 100 bpm. The Avalon fetal monitor provides a Toco MP or CL Toco+ MP transducer for maternal pulse detection and the creation of a maternal heart rate pattern plotted on the same recorder as the FHR pattern. In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 or MECG instead. When either of these parameters is utilized, the monitor will automatically and continuously perform a CCV of the maternal heart rate pattern against the FHR pattern displayed on the monitor. If the patterns and rates are similar, the CCV provides an alarm that both rates are probably from the same source (i.e., they both represent the maternal heart rate pattern and the fetus is not being monitored). Repositioning the ultrasound transducer will usually correct this, but it may be necessary to apply a fetal scalp electrode. Advising the mother to temporarily cease pushing during contractions may help to more rapidly resolve any uncertainty in this situation.Doubling: The autocorrelation algorithm can display a doubled fetal or maternal heart rate if the duration of diastole and systole are similar to each other, and if the heart rate is below 120 bpm. Doubling, usually brief, is accompanied by an abrupt switch of the trace to double the baseline value.Halving: With fetal tachycardia (above 180 bpm) and some interference from breathing or maternal arteries the autocorrelation algorithm may only recognize every second beat resulting in a halved rate for a limited time. If the actual FHR is above the maximum limit of the monitor (240 bpm), the algorithm will also half-count. Halving is accompanied by an abrupt switch of the trace to exactly half the prior baseline value. This switch may simulate an FHR deceleration and be referred to by clinicians as a “false deceleration.”Switching to maternal heart rate (also referred to as "Maternal Insertion"): The fetal heart can move partly or fully out of the ultrasound beam and the autocorrelation algorithm may then pick up and display the maternal heart rate. Depending on the signal mix in the ultrasound signal, switching to the maternal heart rate may mimic several conditions with the potential for erroneous interpretation and response as follows:•The switch to the maternal heart rate may simulate an FHR deceleration (i.e., a decrease of the fetal heart rate, and be referred to by clinicians as a “false deceleration”).
12 Monitoring FHR and FMP Using Ultrasound175•The maternal heart rate may simulate a normal fetal heart rate pattern (i.e., it may mask an FHR deceleration or fetal demise).Especially during pushing with contractions in the second stage of labor, the maternal heart rate may increase to the point where it may equal or exceed the fetal rate. Here the maternal trace may mimic a normal fetal trace while the fetus may be having decelerations or fetal demise has occurred. This change from fetal to maternal heart rate pattern may not be at all obvious unless CCV is used and represents the most dangerous pitfall of all the artifacts because fetal distress may go unrecognized.•The maternal heart rate may simulate an FHR acceleration, which is an increase of the fetal heart rate.During expulsive efforts, the maternal heart rate normally accelerates and may be at or above the normal FHR range.•The FHR may display gradual appearing decelerations. Generally, the “false decelerations” described above are abrupt. Rarely, combinations of “noisy/erratic signal” associated with changes in maternal and/or fetal rate or movement will produce more gradual appearing “false decelerations” but these are usually short-lived with an abrupt return to an obviously stable FHR baseline.“Noisy/Erratic” signals: With mixed or weak signals the tracing may reveal very brief episodes of erratic recorded traces. These represent the autocorrelation algorithm finding brief sequences of apparent and persistent heartbeats amidst a mixed or weak signal. These erratic recorded traces are commonplace, especially in association with fetal or maternal movement. During prolonged periods of such noisy/erratic signals, the fetus is not being adequately monitored.Drop out: With mixed or weak signals there may be no heart rate tracing at all. These episodes reflect that if the algorithm does not find an apparent and persistent heartbeat amidst a mixed or weak signal, it will not print a heart rate on the tracing. Brief episodes of drop out are commonplace, especially in association with fetal or maternal movement. During prolonged periods of drop out, the fetus is not being adequately monitored.Multiple FetusesWith multiple fetuses, the potential to experience these artifacts is increased. Positioning of the transducer is even more critical. Ultrasound scanning should be used to help with positioning of individual transducers. See also “Monitoring Twin FHRs” on page 183 and “Monitoring Triple FHRs” on page 191.
12 Monitoring FHR and FMP Using Ultrasound176Obtaining a Good Heart SignalTo successfully position the ultrasound transducer, first determine the fetal position using palpation. Position the transducer over the strongest audible fetal heart sound from the monitor’s speaker and wait at least six seconds after each transducer adjustment to verify a good signal quality displayed on the Signal Quality Indicator and a consistent FHR numeric display. Having determined the position that provides a strong fetal signal, fix the transducer on the abdomen with the belt.If the quality of the signal or the appearance of the heart rate trace from the ultrasound transducer is questionable, the transducer should be repositioned as described above. Alternatively, the use of an ultrasound scanner will greatly facilitate the determination of the optimal site for the ultrasound heart rate transducer. Factors during the second stage of labor that may influence the quality of the FHR tracing obtained with ultrasound include:• Uterine contractions• Changing contour of the maternal abdomen• Maternal body movement - positioning• Maternal expulsive efforts - pushing• Maternal tachycardia/accelerations with contractions• Fetal decelerations, Fetal tachycardia• Delayed return of the fetal heart rate from a deceleration• Descent of the fetus in the birth canal• Rotation of the fetus in the birth canalIn some cases during the second stage of labor, a good and reliable ultrasound FHR signal may not be obtainable, and the use of a fetal scalp electrode must be considered (fetal ECG).Heart Rate SoundThe heart rate sound emitted by the device is a representation of movement that, in most cases, permits accurate auscultation of the FHR corresponding to the FHR displayed on the monitor and rate pattern depicted on the trace recording. On occasion, the user may hear an FHR that differs from the FHR display and the recorded trace. This may occur in situations where the fetal heart moves partly out of the transducer ultrasound beam. In these cases, the user may hear the FHR emitted from the monitor’s speaker, even though another periodic signal (usually the maternal heart rate) has become stronger. The autocorrelation algorithm will display the stronger maternal heart rate, despite the persistence of a weaker fetal signal. These occurrences are usually very brief and, if persistent, can be addressed by repositioning the transducer.
12 Monitoring FHR and FMP Using Ultrasound177Signal Quality IndicatorThe signal quality on the Avalon fetal monitor is indicated by a triangle on the touchscreen that is displayed in one of three ways:Examples of ArtifactsWhen monitoring the maternal ECG, a beat-to-beat maternal heart rate trace is printed alongside the FHR recorded trace. When monitoring the maternal SpO2 derived pulse rate, a filtered and averaged heart rate trace is printed.Following are recorded trace examples of complaints received regarding inaccurate output from the Avalon monitors. Scaling is 3 cm/min and 30 bpm/cm.1Completely filled triangle, indicating good signal quality (good/full).2Half-filled triangle, indicating limited signal quality. This condition may indicate a weak or ambiguous signal. If this status persists, reposition the transducer (acceptable/medium).3Empty triangle, indicating insufficient signal quality. No FHR is displayed on the monitor’s numeric display or the recorded trace. If this status persists, reposition the transducer (poor/no signal).Double-CountingBaseline Rate 120Baseline Variability ModerateAccelerations PresentDecelerations Not apparent
12 Monitoring FHR and FMP Using Ultrasound178Contractions Excessive, coupling, hypertonusArtifact Double-CountingComment Reassuring tracing. The excessive uterine activity should prompt discontinuation of any oxytocic agent.Remediation The true fetal rate can be confirmed by auscultation or by fetal scalp electrode.Double-CountingHalf-CountingBaseline Rate 120Baseline Variability ModerateAccelerations PresentDecelerations Not apparentContractions MinimalArtifact Half-counting, noise, drop outComment Reassuring tracing. The half-count at 4-5 minutes into the tracing may simulate a fetal deceleration, but the abruptness and the lack of any compensatory changes when the normal rate returns suggests that this is half-counting. Insertion of the maternal heart rate (see below) may produce a similar pattern. Note also very brief episodes of half-counting, maternal insertion, and signal dropout.Remediation Auscultation or the application of a direct scalp electrode, if feasible, will reveal the true fetal heart rate.
12 Monitoring FHR and FMP Using Ultrasound179Maternal-Switching (Maternal Insertion)Baseline Rate 170 - TachycardiaBaseline Variability ModerateAccelerations Unable to determineDecelerations AbsentContractions AbsentArtifact Maternal insertion, noiseComment The fetus has an elevated baseline rate of about 170 bpm with minimal to moderate variability. The ability to assess fetal status is limited because about half of the tracing displays the maternal heart rate.Remediation The application of a maternal transducer (ECG or pulse oximeter) will likely resolve any possible confusion with the tracing. Repositioning the transducer may produce a more reliable tracing. Consideration must also be given to applying a fetal scalp electrode.Noisy/Erratic Signal and DropoutBaseline Rate 140Baseline Variability ModerateAccelerations PresentDecelerations AbsentContractions MinimalArtifact Noisy signal, drop-out
12 Monitoring FHR and FMP Using Ultrasound180Selection of Literature References on Artifacts___________________________________________________________Mosby's Pocket Guide to Fetal Monitoring: A Multidisciplinary Approach (Nursing Pocket Guides) 8th Edition (May 2016).Lisa A. Miller, David A. Miller, Rebecca L. CypherElsevier Ltd, Oxford. 2017, ISBN 978-0-323-40157-9___________________________________________________________Signal ambiguity resulting in unexpected outcome with external fetal heart rate monitoringBy Duncan R. Neilson Jr, MD; Roger K. Freeman, MD; Shelora Mangan, RNC, MSN, CNSAmerican Journal of Obstetrics & Gynecology, June 2008___________________________________________________________Antepartal and Intrapartal Fetal Monitoring, 3rd Edition (2007)By Michelle L. Murray, PhD, RNCSpringer Publishing Company, ISBN 0-8261-3262-6Page 2, Table 2: Limitations of Continuous EFMItem 15: “The US may detect maternal aortic wall movement and the maternal HR will be printed. A failure to recognize the lack of an FHR may delay appropriate management.”Page 38, “Solving Equipment Problems”, Table 3: The Ultrasound Transducer___________________________________________________________JOGC (Journal of Obstetrics and Gynecology Canada)Volume 29, Number 9, September 2007Chapter 2: Intrapartum SurveillancePage S35: “Methods of Electronic Fetal Monitoring”“… Among its disadvantages are the need for readjustment with maternal or fetal movements and the following: the transducer may record the maternal pulse, it may be difficult to obtain a clear tracing in obese women or those with polyhydramnios, artifact may be recorded, and there may be doubling or halving of the fetal heart rate when it is outside of the normal range.”___________________________________________________________Comment Reassuring tracing. Note that there is episodic drop out of the signal with discontinuity of the fetal tracing.Remediation Either improving the position of the transducer or the application of a fetal scalp electrode will reduce the amount of artifact in the tracing.Noisy/Erratic Signal and Dropout
12 Monitoring FHR and FMP Using Ultrasound181Maternal or Fetal Heart Rate? Avoiding Intrapartum Misidentificationby Michelle L. MurrayJOGNN Clinical Issues, April 2003, 33, 93-104; 2004. DOI: 10.1177/0884217503261161Figure 9 "The recording is of the MHR with occasional doubling."___________________________________________________________Maternal Heart Rate Pattern – A Confounding Factor In Intrapartum Fetal SurveillanceSchifrin BS, Harwell R, Hamilton-Rubinstein T, Visser G:Prenat Neonat Med 2001; 6:75-82___________________________________________________________Fetal Monitoring in Practice, 2nd Edition 1998By Donald Gibb, S. ArulkumaranButterworth-Heinemann, ISBN 0-7506-3432-2Page 65, “False or erroneous baseline because of double counting of low baseline FHR”Page 66, “Bradycardia: fetal or maternal”___________________________________________________________Role of Maternal Artifact in Fetal Heart Rate Pattern InterpretationKlapholz, Henry M, MD; Schifrin, Barry S. MD; Myrick, Richard RSObstetrics & Gynecology, September 1974, Volume 44, Issue 3___________________________________________________________
12 Monitoring FHR and FMP Using Ultrasound182
1318313Monitoring Twin FHRsThe FHRs of twins are externally monitored using two ultrasound transducers. The Avalon CL Transducer system provides the option to monitor twins with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option.FM30/50 Twin FHRs are monitored throughout labor and delivery. After rupture of the membranes, you can monitor one twin externally using ultrasound, and the other internally using DECG.Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods.FHR detection by the monitor does not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.Important ConsiderationsWhen monitoring:• Ensure that you are recording two different fetal heart rates. The cross-channel verification feature alerts you if the two heart rates coincide (if both transducers are recording the same FHR). If this happens, check the trace and if necessary, reposition an ultrasound transducer to detect the second FHR correctly.• Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and so on.If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure that the measurement labels remain consistent.Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1.• The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel.
13 Monitoring Twin FHRs184• The fetal sensor socket to which a transducer is connected is identified by the transducer position indicator in the setup menu header:• The trace recorded for FHR1 is thicker (darker) than that recorded for FHR2. This ensures that the two heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode.• Remember that only one fetal heartbeat can be heard from the loudspeaker at a time.• The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see “Selecting Fetal Heart Sound” on page 169).• Monitor maternal pulse, especially during later stages of labor, to avoid mistaking maternal heart rate for FHR.• Make sure that you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary.• For the Avalon CL transducer system, see “Cableless Monitoring - Important Considerations” on page 167.Monitoring Twins ExternallyTo monitor twin FHRs externally, you need two ultrasound transducers. Follow the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 165. The transducer finder LED lets you identify at a glance which transducer is monitoring which FHR channel, and lights when you select the FHR numeric field on the screen.FM20/FM30 FM40/FM50
13 Monitoring Twin FHRs185Example of the screen showing ultrasound monitoring of twin FHRs:Monitoring Twins InternallyFM30/50 Monitor one twin using the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 165. Monitor the second twin using the procedures described in “Monitoring FHR Using DECG” on page 199.Example of a screen showing twin monitoring using a combination of US and DECG (the fetal heart rate monitored via DECG is labeled "dFHR1"/"dFHR2"/"dFHR3" on the screen):Separating FHR TracesTo help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching on trace separation. For details of the offset, see “Separation Order Type” on page 186.1FHR 12Toco parameter3FHR 21dFHR 12Toco parameter3FHR 2
13 Monitoring Twin FHRs186Switching Trace Separation On and OffConnect transducers to the monitor to measure FHR. Depending on the measurement method, you need either two ultrasound transducers or, for FM30/FM50, one ultrasound and one Toco+ transducer, or one CL ECG/IUP transducer (to monitor DECG):1Enter the Main Setup menu by pressing the Main Setup.2Select Fetal Recorder.3Select Trace Separation to switch between On and Off.4Exit the Main Setup menu.Separation Order TypeIn Configuration Mode, you can choose between two methods, Standard and Classic, for dealing with the trace offsets on the recording (the order in which they are separated) when Trace Separation is On.•Standard: the FHR2 trace is shifted up by 20 bpm (it is recorded 20 bpm higher than it really is). No offset is ever applied to the FHR1 trace - it stays where it is (a third FHR would be shifted down by 20 bpm).•Classic: the FHR1 trace is shifted up by 20 bpm when there is more than one FHR measurement. No offset is ever applied to the FHR2 trace - it stays where it is (a third FHR would be shifted down by 20 bpm).When Trace Separation is OnWhen trace separation is turned on, the recorder prints a dotted line labeled with the two FHRs at the top, and +20 at the bottom.Examples of the two methods (Standard, Classic) for determining the trace separation order are provided here."Standard" Separation OrderTo make differentiating the traces easier, the trace from the ultrasound transducer connected to the FHR2 channel is separated from that of FHR1 by 20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is. The trace for FHR1 is never shifted.The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2. The FHR trace is labeled +20 every 5 cm:The label for FHR2 is annotated with a black filled +20:
13 Monitoring Twin FHRs187The following trace shows trace separation switched on.Only the FHR2 trace is offset. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2 value. For example, if the recorded trace shows 160, then the true FHR is 140."Classic" Separation OrderTo make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when FHR2 is present. The FHR2 trace is never shifted.The recorder prints a dotted line labeled+20 across the FHR scale, to identify the trace for FHR1. The FHR trace is labeled +20 every 5 cm:The label for FHR1 is annotated with a black filled +20:The following trace shows trace separation switched on.Only the FHR1 trace is shifted. The numerical FHR value displayed on the monitor remains unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1 value. For example, if the recorded trace shows 160, then the true FHR is 140.
13 Monitoring Twin FHRs188When Trace Separation is OffTo indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.1Standard trace separation switched off here2Classic trace separation switched off here
13 Monitoring Twin FHRs189TroubleshootingCommon problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 165. See also “Monitoring FHR Using DECG” on page 199 for common problems you might encounter when monitoring FHR directly.The following problem may occur when monitoring twins.For more information, see “Additional Information” on page 173.Problem Possible Cause SolutionThe question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.Both transducers are recording the same FHR, or one fetal transducer is recording the maternal HR.Reposition an ultrasound transducer. See “Recommended Actions for Coincidence INOP” on page 164.
13 Monitoring Twin FHRs190
1419114Monitoring Triple FHRsIf your monitor is equipped with the triplets option, it carries the label: You can monitor triple FHRs externally using three ultrasound transducers. With the Avalon CL Transducer system, you can monitor triplets with cableless transducers. The Avalon CTS system and the CL F&M Pod do not have this option.Refer to the appropriate preceding chapters for contraindications, and more information about the available measurement methods.FHR detection by the monitor may not always indicate that the fetuses are alive. Confirm fetal life before monitoring, and continue to confirm that the fetuses are the signal source for the recorded fetal heart rates. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.Important Considerations• The procedures and any contraindications that apply for twins monitoring also apply for monitoring triplets. In addition, when monitoring triplets: Be aware that monitoring three FHRs is inherently more difficult than monitoring single or twin FHRs. The nature of the application increases the likelihood that a fetal heart rate is monitored by more than one transducer.• Ensure that you are recording three different fetal heart rates. Pay particular attention to any coincidence of heart rates detected by the monitor's cross-channel verification feature.• Fetal heart rate measurements are labeled in the order in which you plug in the transducers for those measurements. It does not matter which fetal sensor socket you use, as the monitor allocates a channel automatically. For instance, the first transducer you connect is automatically allocated a channel, and the measurement is labeled FHR1, the second is labeled FHR2, and the third FHR3.If you need to disconnect the transducers measuring the FHR temporarily, with the intention to continue monitoring after the temporary break (for example, if the mother needs to go to the bathroom), it is important that you reconnect the transducers in the same order as you originally connected them to make sure that the measurement labels remain consistent.Upon discharge of the patient all connected transducers are reset from left to right. Example: Only one transducer is still connected to the monitor, it was labeled FHR2 while monitoring the previous discharged patient; it is now reset to FHR1.
14 Monitoring Triple FHRs192• The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel.• The fetal sensor socket to which a transducer is connected, is identified by the transducer position indicator in the setup menu header:• The trace recorded for the FHR3 is thicker (darker) than that recorded for FHR1, which is thicker than that for FHR2. This ensures that the three heart rates are easily distinguishable. The thickness of the recorded trace can be changed in Configuration Mode.• Remember that only one fetal heartbeat can be heard from the loudspeaker at a time. The audio source symbol shows you which fetus you are listening to. To hear the other fetal heartbeat, select the fetal heart rate sound for this channel (see “Selecting Fetal Heart Sound” on page 169).• Monitor maternal pulse to avoid mistaking maternal heart rate for FHR.• Ensure you are recording the best possible signals by referring to the signal quality indicators and repositioning the transducers if necessary.For the Avalon CL transducer system, see “Cableless Monitoring - Important Considerations” on page 167.Monitoring TripletsTo monitor triple FHRs, you need three ultrasound transducers. Follow the procedures described in “Monitoring FHR and FMP Using Ultrasound” on page 165 and in “Monitoring Twin FHRs” on page 183. The transducer finder LED lets you identify at a glance which transducer is monitoring which heart rate channel.Separating FHR TracesTo help you to interpret traces with similar baselines, you can separate the baselines by an offset of 20 bpm by switching on trace separation. For details of the offset, see “Separation Order Type” on page 186.FM20/FM30 FM40/FM50
14 Monitoring Triple FHRs193"Standard" Separation OrderTo make differentiating the traces easier, the trace for FHR2 is offset by +20 bpm, and the trace for FHR3 is offset by -20 bpm. In other words, the trace for FHR2 is recorded 20 bpm higher than it really is, while the trace for FHR3 is recorded 20 bpm lower than it really is. The trace for FHR1 is never shifted.The following trace shows triplets with Trace Separation on, and using Standard separation order.The traces for FHR2 and FHR3 are offset. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR2 to obtain the true FHR2. For example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3.The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR2.The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3.The FHR trace is labeled every 5 cm.The label for FHR2 is annotated with +20 and the FHR3 label is annotated with -20.
14 Monitoring Triple FHRs194"Classic" Separation OrderTo make differentiating the traces easier, the trace for FHR1 is offset by +20 bpm when other FHR measurements are present, and the trace for FHR3 is offset by -20 bpm. The FHR2 trace is never shifted. In other words, the FHR traces are always sorted in ascending order from top to bottom.The following trace shows triplets with Trace Separation on, and using Classic separation order.The traces for FHR1 and FHR3 are shifted. The numerical FHR values displayed on the monitor remain unchanged. Subtract 20 from the recorded trace for FHR1 to obtain the true FHR1. For example, if the recorded trace shows 160 bpm, then the true FHR is 140 bpm. Similarly, add 20 to the recorded trace for FHR3 to obtain the true FHR3.The recorder prints a dotted line labeled +20 across the FHR scale, to identify the trace for FHR1.The recorder prints a dotted line labeled -20 across the FHR scale, to identify the trace for FHR3.The FHR trace is labeled every 5 cm.The label for FHR1 is annotated with +20 and the FHR3 label is annotated with -20.
14 Monitoring Triple FHRs195Switching Trace Separation On and Off1Connect three ultrasound transducers to the monitor to measure FHR.2See “Switching Trace Separation On and Off” on page 186 for details of how to switch trace separation on or off.When Trace Separation is OnWhen trace separation is turned on, the recorder prints a dotted line labeled with the three FHRs at the top, and ±20 at the bottom. Examples of the two methods (Standard, Classic) for determining the trace separation order are provided here.When Trace Separation is OffTo indicate that trace separation is switched off, a dotted line labeled +0 prints across the FHR scale.1Standard trace separation switched off here
14 Monitoring Triple FHRs196TroubleshootingCommon problems that may occur when monitoring FHR using ultrasound are listed in “Monitoring FHR and FMP Using Ultrasound” on page 165.The following problem may occur when monitoring triplets.For more information, see “Additional Information” on page 173.2Classic trace separation switched off hereProblem Possible Cause SolutionThe question mark is printed repeatedly, and appears on the screen and the INOP Coincidence is issued.More than one transducer is recording the same FHR, or a fetal transducer records the same heart rate as the maternal HR.Reposition one or more ultrasound transducer, as appropriate. See “Recommended Actions for Coincidence INOP” on page 164
1519715Fetal Heart Rate AlarmsFetal heart rate (FHR) alarms can give both audible and visual warning of a non-reassuring fetal condition. Your monitor must be configured to alarm mode All to enable the FHR alarms (see “Alarms” on page 117).Changing Alarm SettingsWhen you do any of the following actions for any FHR measurement channel, this applies for all active FHR measurements, ultrasound, DECG, and aFHR:• Turning FHR alarms on or off• Changing alarm limits• Changing alarm delays• Changing signal loss delayThe monitor retains these settings, even when switched off. The alarm limits are printed on the trace every few pages if alarms are on.Turning Alarms On or Off1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3Select Alarms to switch between On and Off.Changing Alarm Limits1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3To change the high alarm limit, select High Limit and select the alarm limit from the pop-up list.4To change the low alarm limit, select Low Limit and select the alarm limit from the pop-up list.
15 Fetal Heart Rate Alarms198Changing Alarm DelaysYou can change the alarm delays if the Alarm Mode is set to All.1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3To change the high alarm limit delay time, select High Delay and select the delay time (in seconds) from the pop-up list.4To change the low alarm limit delay time in seconds, select Low Delay and select the delay time (in seconds) from the pop-up list.Changing Signal Loss DelayThe signal loss delay is the configurable delay before a Signal Loss INOP is issued. You can change the delay:1Connect either an ultrasound or a DECG transducer to a free socket on the monitor, or use the CL F&M Pod.2Enter the setup menu for a connected FHR measurement.3Select SignalLoss Delay and select the signal loss INOP delay time (in seconds) from the pop-up list.
1619916Monitoring FHR Using DECGFM30/50 This chapter describes how to monitor a single fetal heart rate via direct ECG (DECG), using a spiral fetal scalp electrode in the intrapartum period.Read and adhere to the instructions that accompany the fetal scalp electrode, the DECG adapter cable, and the attachment electrode. Pay attention to all the contraindications, warnings, and for the DECG adapter cable, the cleaning and disinfection procedures.Before starting to monitor, first define the fetal position, and ensure that it is suitable for DECG monitoring.Misidentification of Maternal HR as FHRConfirm fetal life before monitoring, and continue to confirm that the fetus is the signal source for the FHR during monitoring. Here are two examples where the maternal HR can be misidentified as the FHR when using a fetal scalp electrode:• Electrical impulses from the maternal heart can sometimes be transmitted to the fetal monitor through a recently deceased fetus via the spiral scalp electrode, appearing to be a fetal signal source.• The recorded maternal HR, and any artifact, can be misinterpreted as an FHR especially when it is over 100 bpm.To reduce the possibility of mistaking the maternal HR for FHR, monitor both maternal and fetal heart rates (see “Monitoring Maternal Heart / Pulse Rate” on page 221). The monitor's cross-channel verification (CCV) facility can help by automatically detecting when the same heart rate is being recorded by different transducers. See “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.If the Coincidence INOP is issued at the fetal monitor if you are measuring FHR with DECG:1Confirm that the scalp electrode is placed correctly.2Confirm fetal life by palpation of fetal movement or auscultation of fetal heart sounds using a fetoscope, stethoscope, or Pinard stethoscope.3If you cannot hear the fetal heart sounds, and you cannot confirm fetal movement by palpation, confirm fetal life using obstetric ultrasonography.
16 Monitoring FHR Using DECG2004In case of difficulties deriving a stable maternal pulse reading using the Toco MP or CL Toco+ MP transducer, use SpO2 instead. In case of similar problems with the pulse measurement from SpO2, use MECG instead. Reasons to switch the method for deriving a maternal pulse or heart rate include: motion artifacts, arrhythmia, and individual differences in pulse signal quality on the abdominal skin (via Toco+ MP).What You NeedYou can measure fetal DECG using the equipment combinations shown in the following figures.WARNINGNever attempt to connect the fetal scalp electrode to anything other than the correct DECG adapter cable.DECG with Toco+The figure below shows the complete connection chain from the fetal scalp electrode to the fetal monitor using the Toco+ transducer.1Fetal Scalp Electrode, single spiral (989803137631)2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)4Toco+ transducer (M2735A)
16 Monitoring FHR Using DECG201DECG with CL Toco+MP or CL ECG/IUPThe figure below shows the equivalent chain using the CL Toco+ MP or CL ECG/IUP transducer.1Fetal Scalp Electrode, single spiral (989803137631)2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)4CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)5Avalon CL base station (866074)DECG with Patient ModuleThe figure below shows the equivalent chain using the patient module.1Fetal Scalp Electrode, single spiral, (989803137631)2Fetal Scalp Electrode, double spiral, Europe only, not for USA (989803137641)3DECG Adapter Cable (9898 031 37651) with Pre-gelled Attachment Electrode (989803139771)4Patient Module (M2738A)
16 Monitoring FHR Using DECG202Making ConnectionsWARNINGFollow the instructions supplied with each of the monitoring accessories you are using.Prepare for DECG monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1If you change the monitoring mode from US to DECG, first disconnect the US transducer.2Depending on the equipment you are using, ensure that the Toco+ transducer, CL Toco+ MP, the CL ECG/IUP transducer, or the patient module is connected to the fetal monitor.3Attach the fetal scalp electrode to the fetus, following the instructions supplied with the fetal scalp electrode.4Attach a pre-gelled attachment electrode to the DECG adapter cable, following the instructions supplied with the DECG adapter cable.5Fix the attachment electrode to the mother's thigh, following the instructions supplied with the attachment electrode.Depending on the equipment you are using, connect the red connector plug on the DECG adapter cable to the red connector on the Toco+ transducer, CL Toco+ MP, the CL ECG/IUP transducer, or the patient module.6Connect the fetal scalp electrode to the DECG adapter cable.You are now ready to begin monitoring DECG.WARNINGThe fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform.When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g. checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e. P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.Monitoring DECGTo simultaneously measure DECG and MECG, you need the CL ECG/IUP transducer or the patient module for DECG, and a Toco+, CL Toco+ MP, or CL ECG/IUP transducer for MECG (see “Monitoring Maternal Heart / Pulse Rate” on page 221). Alternatively, you can monitor the maternal pulse rate via pulse oximetry (see “Pulse Rate from SpO2” on page 228). You can also monitor maternal pulse with the Toco MP or CL Toco+ MP transducer. In any case where you would use a Toco+ or Toco MP transducer, you can also monitor with a CL Toco+ MP transducer.1Switch on the recorder.
16 Monitoring FHR Using DECG2032The heart rate monitored via DECG is labeled dFHR1 / dFHR2 / dFHR3 on the screen. If configured, the DECG wave is displayed automatically on the screen, labeled DECG, and fetal. If MECG is being monitored, both waves are displayed, with the DECG wave above the MECG wave. The MECG wave is labeled MECG and maternal.3Check the artifact suppression setting and change it if necessary (see “Suppressing Artifacts” on page 204).NOTEThe 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG.1Measurement label (dFHR1)2Measurement label (Toco)3Measurement label (FHR2)4Measurement label (HR)51mV scale bar6MECG wave with maternal label7DECG wave with fetal label8Measurement label (Temp) maternal temperature9Measurement label NBP
16 Monitoring FHR Using DECG204WARNINGPeriodically compare the mother's pulse with the signal coming from the monitor's loudspeaker to ensure that you are monitoring fetal heart rate. If the maternal HR coincides with the FHR, do not misinterpret the maternal HR as the FHR (see also “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159.Suppressing ArtifactsWhen the monitor's artifact suppression is on, instantaneous heart rate changes of 28 bpm or more, however caused, are not recorded. Fetal arrhythmia will also be suppressed. If you suspect fetal arrhythmia, switch artifact suppression off. When artifact suppression is off, all recorded fetal heartbeats within the specified range are shown. The default setting is On (artifacts are suppressed).To change the setting:1Enter the Setup dFHR1 menu.2Select ArtifactSuppress to switch between artifact suppression On (artifacts are suppressed) and Off (no artifact suppression, use this setting if you suspect fetal arrhythmia).When artifact suppression is off, Artifact Suppression Off is annotated on the trace recording.Printing the WaveformYou can print the DECG wave onto the trace paper. Refer to “Printing the ECG Waveform” on page 231.
16 Monitoring FHR Using DECG205TroubleshootingNOTEIn many cases you need to see the DECG wave to check if the signal quality is good enough to derive a valid fetal heart rate. In the dFHR setup menu, switch on the display of the DECG wave.Testing DECG ModeSee the monitor's Service Guide.Problem Possible Cause SolutionsdFHR1 Equip Malf dFHR2 Equip Malf dFHR3 Equip MalfMalfunctioning equipment See “Patient Alarms and INOPs” on page 129.dFHR1 Leads Off dFHR2 Leads Off dFHR3 Leads OffNumeric is displayed with a -?-; INOP toneSee also “Patient Alarms and INOPs” on page 129.Erratic trace Erratic displayFetal scalp electrode detached at connectorReconnect the fetal scalp electrodeIf the wave is configured to be displayed on the monitor, you can observe if the ECG signal is clear, or if it shows interruptions and noisePoor or no contact between leg attachment electrode and motherCheck all connectionsDisconnect and reconnect the connector several timesNo contact between the DECG adapter cable and the leg attachment electrodeNo contact between the fetal scalp electrode connector and the DECG adapter cableCheck all connectionsDisconnect and reconnect the connector several timesIf problem persists, use a new fetal scalp electrodeNo ECG signalPoor contact between the reference electrode and the motherCheck for fetal demiseUse a new fetal scalp electrode if necessarySignal quality indicator continuously shows a poor signalFetal arrhythmia Use a new fetal scalp electrode if necessarydFHR1 Signal Loss dFHR2 Signal Loss dFHR3 Signal LossNo signal See “Patient Alarms and INOPs” on page 129.dFHR1 Unplugged dFHR2 Unplugged dFHR3 UnpluggedNo connection See “Patient Alarms and INOPs” on page 129.
16 Monitoring FHR Using DECG206
1720717Monitoring Uterine Activity ExternallyYou can measure uterine activity externally using a Toco transducer. You can also use a Toco+, Toco MP, or a CL Toco+ MP transducer for the same purpose, although they also have more (ECG/IUP and Pulse) capabilities.The external Toco transducer allows to monitor the frequency, duration, and relative strength of contractions, but not their absolute intensity. Amplitude and sensitivity depend on various factors such as the position of the transducer, the belt tension, and the size of the patient.What You NeedToco, Toco MP, or Toco+ transducerCL Toco+ MP transducers (additionally capable of providing the maternal pulse measurement)
17 Monitoring Uterine Activity Externally208External Toco MonitoringPrepare for Toco monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1Fasten the abdominal transducer belt around the patient.2Connect the Toco transducer to a free socket on the monitor. The Toco baseline is automatically reset. The Toco display shows 20. "Toco", indicating external uterine measurement, is printed on the trace at intervals.3Place the transducer on the patient's fundus to ensure the optimum recording of uterine activity.4Reset the Toco baseline as necessary (see “Resetting the Toco Baseline” on page 208), but not during a contraction.The following example trace shows two contractions.Resetting the Toco Baseline1Press the Toco Baseline SmartKey. This resets the Toco baseline to 20 on the display and trace.2If the Toco value is negative for more that five seconds, the Toco baseline is automatically reset to 0 units.Toco SensitivityIf the Toco sensitivity is too high, and the Toco trace exceeds the paper scale, you can reduce the Toco sensitivity to 50%. The default setting is 100%.To change the Toco sensitivity:1Enter the Setup Toco menu.2Select Gain to switch between 100% and 50%.TroubleshootingAbdominal Belt (disposable shown)
17 Monitoring Uterine Activity Externally209External Toco MonitoringProblem Possible Causes SolutionsQuality of the trace deteriorates or the Toco baseline variesThe belt is incorrectly fastened and is too slack or too tight, or the belt has lost its elasticity.The belt must be tight enough to ensure good contact between the patient's skin and the entire surface of the transducer without causing discomfort. Ensure you are using the correct belt. Adjust it as necessary.Fetal movement Check if the belt is correctly fastened and adjust it as necessary. Reposition the transducer and reset the Toco baseline if necessary.Maternal respiration superimposed on traceCheck if belt is not too loose.Maternal movement/change of position Following maternal movement, reset Toco baselineToco sensitivity is too high (above 100 units)Toco trace is exceeding the paper scalePhysical transmission of pressure from the uterus to the sensor is much higher than the average value.Check if the belt is too tightly fastened.Select 50% Toco sensitivity.Toco Equip Malf is displayed. See “Patient Alarms and INOPs” on page 129.Toco Unplugged is displayed. See “Patient Alarms and INOPs” on page 129.If you suspect the signal from the transducer. Test the Transducer (see “Testing Toco Transducers” on page 210 below).
17 Monitoring Uterine Activity Externally210Testing Toco TransducersIf any of the following tests fail, repeat the test using another transducer. If the second transducer passes the tests, confirming that the first transducer is defective, contact your service personnel.If the second transducer also fails the tests, contact your service personnel.You can test all Toco transducers, including the cableless ones, as described above.To test a Toco transducer:1Switch on the monitor and the recorder.2Connect the transducer to the fetal monitor.3Gently apply pressure to the pick-up button.4Check if after a few seconds the values on the display and paper show this change in pressure.
1821118Monitoring Uterine Activity InternallyFM30/50 You can monitor intrauterine pressure (IUP) using an intrauterine catheter together with a patient module, Toco+, or the CL ECG/IUP or CL Toco+ MP transducer, after rupture of the membranes and the cervix is sufficiently dilated.What You NeedIUP with Patient ModuleThe figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the patient module:1Disposable Koala IUP Catheter (M1333A)2Reusable Koala IUP Adapter Cable (9898 031 43931)3Patient Module (M2738A)
18 Monitoring Uterine Activity Internally212IUP with Toco+The figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the Toco+ transducer:1Disposable Koala IUP Catheter (M1333A)2Reusable Koala IUP Adapter Cable (9898 031 43931)3Toco+ transducer (M2735A)IUP with CL ECG/IUPThe figure below shows the complete connection chain from the IUP catheter to the fetal monitor using the CL ECG/IUP transducer:1Disposable Koala IUP Catheter (M1333A)2Reusable Koala IUP Adapter Cable (9898 031 43931)3CL ECG/IUP or CL Toco+ MP transducer (866077)4Avalon CL base station (866074)
18 Monitoring Uterine Activity Internally213Internal (IUP) MonitoringRead the instructions that accompany the intrauterine catheter and the adapter cable before you start monitoring. Zero the IUP measurement when instructed.WARNINGDo not catheterize if placenta previa is diagnosed, or if uterine bleeding from an undetermined source is present.Prepare for IUP monitoring using the list below. The standard procedures in use in your facility determine the sequence of actions.1Perform a complete clinical evaluation.2Catheterize after membrane rupture. Insert the catheter according to its accompanying instructions.3Connect the catheter to the socket on the patient module.4Connect the patient module to a free socket on the monitor. The monitor is automatically zeroed. The IUP display shows 0. IUP, indicating internal measurement is printed at intervals on the trace.5Zero the IUP measurement (see “Zero The IUP Measurement” on page 213).6If you suspect the catheter is not responding appropriately, flush as directed in the catheter's Instructions for Use. A pressure spike appears on the trace if you flush after connecting the transducer to the monitor.Zero The IUP MeasurementZero the IUP measurement by selecting the Zero IUP SmartKey, or selecting Zero IUP in the Setup IUP menu. This resets the display and trace to 0. If you do not zero the monitor properly, the pressure trace may exceed the paper scaling.Selecting the IUP UnitYou can select between mmHg (default) and kPa for the IUP unit.1Enter the Setup IUP menu.2Press Unit to switch between mmHg and kPa.
18 Monitoring Uterine Activity Internally214TroubleshootingInternal (IUP) MonitoringProblem Possible Causes SolutionsOnly pressure peaks can be seen (baseline not visible).Zero adjustment is incorrect. Zero the IUP measurement.No change in pressure during contraction.Catheter tip not in contact with amniotic fluid or possible extra-ovular placement of the catheter.Refer to catheter Instructions for Use.Trace is a straight line. Connection issue or cable or catheter defective.• Unplug/replug catheter• Unplug/replug or exchange adapter cable• Try new catheterTrace is superimposed with noise. Possible extra-ovular placement of catheter.Refer to catheter Instructions for Use.IUP Equip Malf INOP is displayed. See “Patient Alarms and INOPs” on page 129.IUP Unplugged INOP is displayed.
1921519Monitoring aFHR, aHR, and aTocoIntroducing the abdominal Avalon CL Fetal & Maternal Pod MeasurementThe Avalon CL Fetal & Maternal Pod (CL F&M Pod) noninvasively measures fetal heart rate (aFHR), maternal heart rate (aHR), and uterine activity (aToco). The CL F&M Pod is used together with a single-use electrode patch. The electrode patch has five adhesive electrodes. The CL F&M Pod and electrode patch are placed on the maternal abdomen. It picks up the fetal and maternal electrocardiography (ECG) signals, and the uterine electromyography (EMG) signals. The CL F&M Pod separates and processes the signals, and transmits aFHR, aHR, and aToco to the fetal monitor via the CL base station.CAUTIONUse the CL F&M Pod and electrode patch with singleton pregnancies only. The measurements have been validated with a gestational age of >36 weeks.NOTE• Fetal ECG and uterine EMG signals are very small. Therefore, skin preparation is required when applying the electrodes.• Different measurements for the same physiological parameter may have a different appearance on the trace, due to variability (HR), averaging, delay, amplitude, or artifacts.• The beat-to-beat variability of aFHR may appear lower than FHR from ultrasound and lower than dFHR from DECG due to averaging. The accuracy of all FHR parameters is sufficient for diagnosis following commonly agreed guidelines.Fetal Heart Rate aFHRIt is recommended to verify the presence of the fetal heart beat, for example with a stethoscope, before starting continuous monitoring with the CL F&M Pod.
19 Monitoring aFHR, aHR, and aToco216CAUTIONIf the aFHR signal quality indicator on the fetal monitor screen continuously indicates an insufficient signal quality (empty triangle), although the CL F&M electrode status is green, then an alternative method to monitor should be used.Uterine Activity aTocoThe CL F&M Pod measures the electrical activity of the uterus which is different to the mechanical measurements of a Toco transducer or an IUP catheter. Depending on the measurement method, the shape of a recorded contraction can look different. The uterine EMG signals can be interfered with by the electrical activity of other muscles, for example during maternal or fetal movements or position changes.CAUTIONThe aToco measurement does not represent the absolute intrauterine pressure. If aToco seems questionable, verify uterine activity by other means (maternal perception, manual palpation, or intrauterine pressure (IUP) measurement). For monitoring the real intrauterine pressure in mmHg or kPa, an IUP catheter is required. CAUTIONThe duration of the contraction measured by the CL F&M Pod can be shorter than the physical contractions. When you palpate the uterus, there is a delay between the manual detection of contraction, and when it is displayed at the monitor.CAUTIONMaternal or fetal movements can cause electrical signals that may result in intrauterine contraction-like artifacts.Maternal movementWhen consistent maternal movement is detected:• A question mark is displayed in front of the aToco numeric at the monitor (?aToco).• The aToco trace is printed with a lighter intensity for the duration of the maternal movements, indicating that the signal may be compromised and not suitable for trace interpretation.Uterine Activity Measurement PriorityWhen several uterine activity measurements are active, the priority given on the monitor display is:• IUP (Intrauterine pressure from the connection with an IUP catheter)•aToco (CL F&M Pod)•Toco (CL Toco+MP transducer, Toco+ or Toco MP wired transducer)
19 Monitoring aFHR, aHR, and aToco217aToco SensitivityMonitoring with the CL F&M Pod, the aToco sensitivity can be set to High or Low at any time. The Low sensitivity setting provides an additional suppression of artifacts, for example artifacts coming from maternal and fetal movements. The additional filtering delays the onset of recording the contraction on the trace and shows a reduced amplitude.The default setting is High and recommended for active labor.Setting the aToco Sensitivity1Select the Setup aToco menu.2Select the Sensitivity by toggling between High and Low.What You Need• For monitoring with the CL F&M Pod, see “Avalon CL Fetal & Maternal Pod” on page 21 and “CL Fetal & Maternal Electrode Patch” on page 91.• For assigning the CL F&M Pod, see “CL Pod Assignment” on page 99.• For applying the electrode patch and the CL F&M Pod, see “Applying the CL Fetal & Maternal Patch and Pod” on page 100.At the Monitor1Switch on the recorder.2The fetal heart rate is labeled aFHR1, aFHR2, or aFHR3 on the screen. The CL F&M Pod monitors only singletons, but if in addition to aFHR a CL US transducer and/or a scalp electrode (DECG) are used to monitor FHR, the aFHR numeric is labeled 1 to 3 depending on the sequence in which the other measurement methods are added.3aFHR and aHR have a QRS tone. The volume can be set in the measurement's setup menu, see “Selecting Fetal Heart Sound” on page 169.
19 Monitoring aFHR, aHR, and aToco218Troubleshooting1Measurement label aFHR2Measurement label aToco3Measurement label aHRProblem Possible Causes SolutionsErratic traceErratic displayFetal arrhythmia Consider monitoring FHR with alternative methods.Electrode contact not optimal Reposition the electrode and repeat the skin preparation until the CL F&M Status shows that all electrodes have good contact.Obese patient If a patient is obese, re-position the lower electrode on the midline 1-2 in/3-5 cm below the original placement, or on the underside of the panniculus just below the turn.Too much maternal or fetal movementAsk the patient to sit or lie still until the signal improves. If the signal indication does not improve, consider monitoring with alternative methods.
19 Monitoring aFHR, aHR, and aToco219NOTEFor all signal loss, malfunction, or other alerts see “Patient Alarms and INOPs” on page 129.Signal quality indicator is continuously poorElectrode contact not optimal Repeat the skin preparation until the CL F&M Status shows that all electrodes have good contact.Patient in unfavorable position Make the patient more comfortable, if the abdominal muscles are relaxed it may improve the signal. For example, place a pillow to support the patient’s back. If the signal indication does not improve, consider monitoring with alternative methods.Mobile abdomen If the abdomen is mobile, or patient position has changed, use a rolled blanket/towel or pillow to support abdomen to keep the patch centered on the uterus. If the signal indication does not improve, consider monitoring with alternative methods.aFHR not recorded or questionableaFHR is less than 60 bpm or over 240 bpm, fetal demise, fetal arrhythmia, or the baby is bornVerify the FHR by independent means.Problem Possible Causes Solutions
19 Monitoring aFHR, aHR, and aToco220
2022120Monitoring Maternal Heart / Pulse RateYou can monitor the maternal heart/pulse rate using one of five sources:• Maternal heart rate (HR) via MECG electrodes• Maternal heart rate (aHR) via CL F&M Pod• Maternal pulse rate from Toco MP or CL Toco+ MP transducer (Pulse)• Maternal pulse rate from SpO2 (Pulse)• Maternal pulse rate from NBP (Pulse)Maternal heart/pulse rates derived from Toco MP or CL Toco+ MP, SpO2, aHR, and MECG are continuous measurements, and are compared against the FHR for cross-channel verification. Average pulse rate derived from noninvasive blood pressure is an intermittent measurement, and is therefore not used for cross-channel verification.Priority for Maternal Heart / Pulse RateOnly one maternal heart rate/pulse rate numeric is displayed and recorded at a time (see priority table). If higher-priority measurements are connected but temporarily not providing valid numerics, lower-priority numerics may be displayed and recorded instead.Priority Maternal Heart / Pulse Rate SourceAlarming Used for CCV Provides QRS Tone1 HR from MECG measurement Yes Yes Yes2 aHR from CL F&M Pod Yes Yes Yes3 Pulse from CL SpO2 Pod measurementYes Yes No4 Pulse from SpO2 measurement Yes Yes Yes5 Pulse from Toco MP measurement cableless or cabled No Yes No6 Pulse from CL NBP Pod measurementNo No No7 Pulse from NBP measurement No No No
20 Monitoring Maternal Heart / Pulse Rate222Misidentification of Maternal HR for FHRTo reduce the possibility of mistaking the maternal HR for FHR, it is recommended that you monitor both maternal and fetal heart rates (see “Confirm Fetal Life Before Using the Monitor” on page 10 and “Cross-Channel Verification (CCV)” on page 159).Maternal HR from MECG ElectrodesYou can measure maternal HR using the equipment combinations shown in the following figures.MECG with Patient ModuleThe figure below shows the complete connection chain from the foam electrodes applied to the patient to the fetal monitor using the patient module.1Patient Module (M2738A)2MECG Adapter Cable (M1363A)3Pre-gelled Foam Electrodes (40493A/B/C/D/E)
20 Monitoring Maternal Heart / Pulse Rate223MECG with Toco+The figure below shows the equivalent chain using the Toco+ transducer.1Toco+ Transducer (M2735A)2MECG Adapter Cable (M1363A)3Pre-gelled Foam Electrodes (40493A/B/C/D/E)MECG with CL Toco+MP or CL ECG/IUPThe figure below shows the equivalent chain using a CL Toco+ MP transducer or a CL ECG/IUP transducer.1Avalon CL base station (866074)2CL Toco+ MP (866075) or CL ECG/IUP transducer (866077)3MECG Adapter Cable (M1363A)4Pre-gelled Foam Electrodes (40493A/B/C/D/E)To simultaneously measure DECG and MECG, you can use a Toco+, a CL Toco+ MP, or a CL ECG/IUP transducer for MECG. For measuring DECG, you need a CL ECG/IUP transducer or a patient module (see also “Monitoring FHR Using DECG” on page 199).
20 Monitoring Maternal Heart / Pulse Rate224Applying ElectrodesTo derive the maternal HR (when you do not want to view the MECG waveform), you can place the electrodes just below the outer end of the clavicle near each shoulder.Making ConnectionsWARNINGFollow the instructions supplied with each of the monitoring accessories you are using.Prepare for monitoring maternal HR using the list below. The standard procedures in use in your facility determine the sequence of actions.1Depending on the equipment you are using, ensure that either the Patient Module or the Toco+ transducer is connected to the fetal monitor. If you are using cableless monitoring, use the CL ECG/IUP or the CL Toco+ MP transducer.2Connect a pre-gelled foam electrode to each of the two leads on the MECG adapter cable.3Apply the foam electrodes to the patient, following the instructions supplied with the foam electrodes.4Depending on the equipment you are using, connect the pink connector plug on the MECG adapter cable to the pink connector on either the Patient Module or the Toco+ transducer. If you are using cableless monitoring, connect the MECG Adapter cable to the connectors of the CL ECG/IUP or the CL Toco+ MP transducer.You are now ready to monitor maternal HR.Monitoring Maternal HR1Switch on the recorder.2The maternal heart rate is labeled HR on the screen.1MECG Electrodes
20 Monitoring Maternal Heart / Pulse Rate225Monitoring MECG WaveWARNINGThe fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform.When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.FM30/50 When measuring MECG with the Avalon FM30 or FM50, the MECG waveform, along with the heart rate numeric, is displayed on the screen when using a Toco+, CL Toco+ MP transducer, a patient module, or a CL ECG/IUP transducer. If a maternal ECG wave analysis is required, use a patient monitor.WARNINGThe fetal/maternal monitor is NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result.Applying ElectrodesTo obtain a satisfactory maternal ECG waveform, you must use the RA to LL (lead II) position of the standard 5-lead ECG.1Place the RA electrode (A) directly below the clavicle and near the right shoulder.2Place the LL electrode (B) on the left lower abdomen.
20 Monitoring Maternal Heart / Pulse Rate226Viewing the Waveform on the ScreenNOTEThe 1mV scale bar for the DECG and MECG wave is not displayed on the screen if you monitor DECG or MECG with an Avalon CTS system. The Avalon CTS system does not provide a scaled ECG.For the FM30/50, the MECG wave is displayed automatically on the screen, labeled MECG. If DECG is also being monitored (FM30/50), and the DECG Wave is configured to On, both waves are displayed, with the DECG Wave above the MECG wave. The DECG Wave is labeled DECG.1Measurement label dFHR12Measurement label Toco3Measurement label FHR24Measurement label HR51mV scale bar6MECG wave with maternal label7DECG wave with fetal label8Measurement label Temp maternal temperature9Measurement label NBP
20 Monitoring Maternal Heart / Pulse Rate227TroubleshootingPrinting the WaveformYou can print the MECG wave onto the trace paper. Refer to “Printing the ECG Waveform” on page 231.Pulse Rate from Toco MPThe maternal pulse is taken from the Toco MP or CL Toco+ MP transducer when SpO2 or MECG measurements are not used or have signal loss. When the pulse rate is very low, or strong arrhythmia is present, the pulse rate measured by the Toco MP or CL Toco+ MP transducer may differ from the heart rate calculated from MECG. If the mother is moving about, or began pressing during the second stage of labor, this can cause longer gaps in the recording of the maternal pulse signal. In this case, use the SpO2 or MECG measurement to derive the maternal heart rate.WARNING• No alarm is possible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate.• No QRS tone is audible when Toco MP or CL Toco+ MP transducer is the source of the pulse rate.• The Toco MP or CL Toco+ MP transducer signal is significantly less reliable, if the patient is up and moving about, or is pushing during the second stage of labor.NOTEIn rare cases, it is possible to pick up a fetal signal source. When a Toco MP or CL Toco+ MP transducer is connected to the monitor, but not applied to the patient, the measurement may generate unexpected intermittent pulse readings.Problem Possible Causes SolutionsMECG Leads Off displayed.Numeric is displayed with a -?- for 10 seconds; INOP toneSee also “Patient Alarms and INOPs” on page 129One or more MECG leads is not attached.Make sure that all required leads are attachedIf the wave is configured to be displayed on the monitor, you can observe if the ECG signal is clear, or if it shows interruptions and noiseBad electrical contact Check positioning of the electrode, ensuring that none are displacedCheck electrodes and replace if necessaryElectrodes defectiveprints repeatedlyThe ultrasound transducer is measuring maternal pulseReposition the ultrasound transducer. See “Recommended Actions for Coincidence INOP” on page 164MECG Equip Malf displayed Equipment malfunctions See “Patient Alarms and INOPs” on page 129MECG UnpluggedEquipment not connected
20 Monitoring Maternal Heart / Pulse Rate228Pulse Rate from SpO2If you are not monitoring maternal HR via MECG electrodes, but you are monitoring SpO2, the maternal pulse rate is derived from the SpO2 measurement. The pulse numeric is labeled Pulse on the screen.WARNING• No QRS tone is audible when the CL SpO2 Pod is the source of the pulse rate.Adjusting the Heart Rate / Pulse Alarm LimitsTo adjust the pulse alarm limits for SpO2:1In the Setup SpO menu, select Pulse (SpO). This opens the Setup Pulse (SpO) menu.2Ensure Pulse (SpO) is On. Select Pulse (SpO) to switch between On and Off.3Set the pulse alarm limit:– Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list.– Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list.To adjust the pulse alarm limits for MECG:1In the Setup MECG menu, select MECG/Pulse Alarms. This opens the Setup Pulse (MECG) menu.2Ensure Pulse MECG is On. Select Pulse MECG to switch between On and Off.3Set the pulse alarm limit.– Select High Limit then choose the upper alarm limit for tachycardia from the pop-up list.– Select Low Limit then choose the lower alarm limit for bradycardia from the pop-up list.Average Pulse Rate from Noninvasive Blood PressureWARNINGNo alarm is possible when noninvasive blood pressure is the source of the pulse rate.When you are measuring noninvasive blood pressure, the monitor can also calculate the average pulse rate. This occurs in either manual or automatic mode, when neither MECG, SpO2 nor pulse from Toco MP or CL Toco+ MP transducer are measured. The value is displayed on the screen, and printed on the trace. It is not the actual pulse value, but an average pulse rate, taken during the most recent noninvasive blood pressure measurement. The value is updated after each successive measurement. If you need a continuous measurement, you should monitor using MECG, SpO2, or pulse from Toco MP or CL Toco+ MP transducer.
20 Monitoring Maternal Heart / Pulse Rate229Testing MECG ModeSee the monitor's Service Guide.
20 Monitoring Maternal Heart / Pulse Rate230
2123121Printing the ECG WaveformFM30/50 You can print the ECG wave onto the trace paper. If you are monitoring both DECG and MECG, both waves will be printed. The start of the wave recording is annotated above the wave with MECG for Maternal ECG, with DECG for Direct fetal ECG, and with 25 mm/sec below the wave. When only MECG and/or DECG are measured without any real-time recording, the 25 mm/sec recorder speed is printed in the trace header.WARNING1The fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform.When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.The ECG waveform is printed along the bottom of the heart rate grid, and the three different possibilities look like this:DECG waveform on its own1DECG2Recorder speed
21 Printing the ECG Waveform232MECG waveform on its own1MECG2Recorder speedDECG and MECG waveforms1DECG2MECG3Recorder speedWhen the recorder is on, there are two choices for printing the ECG wave:•Separate: This recording mode gives you a six-second ECG strip on the fetal trace paper in fast printout mode. The real-time fetal trace recording is temporarily interrupted while the ECG strip prints. A new MECG header is printed to mark where the MECG wave starts, and a new trace header and FHR header mark when the fetal trace resumes.
21 Printing the ECG Waveform233The following trace shows the MECG waveform:1FHR1 trace interrupted2MECG header3Recorder speed4FHR1 trace resume•Overlap: This recording mode gives you a delayed six-second snapshot of the maternal and/or direct fetal ECG for documentation on the fetal strip, but without interrupting the fetal trace. It takes 5 minutes to print this six-second snapshot at a recorder speed of 3 cm/min. It is documented as if it was recorded at 25 mm/s.
21 Printing the ECG Waveform234The following trace shows both the DECG and MECG waveforms:1FHR1 and FHR22DECG header3MECG header4Recorder speedTo make your choice:1Enter the Main Setup menu.2Select Fetal Recorder to enter the Fetal Recorder menu.3Select ECG Wave to switch between Separate and Overlap.To print the ECG wave(s):1Select the Record ECG Wave SmartKey (configurable) and the recording trace is started.Or1Enter the Main Setup menu by selecting the SmartKey.2Select Fetal Recorder to enter the Fetal Recorder menu.3Select Record ECG Wave and the recording trace is started.Or1Select the ECG Wave.2Select Record ECG Wave in the ECG wave menu and the recording trace is started.
2223522Monitoring Noninvasive Blood PressureThe noninvasive blood pressure measurement (NBP) is intended for use with maternal patients.This monitor uses the oscillometric method for measuring NBP.A physician must determine the clinical significance of the NBP information.Introducing the Oscillometric Noninvasive Blood Pressure MeasurementOscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock), oscillometric devices are more accurate and consistent than devices using other noninvasive measuring techniques.WARNINGIntravenous infusion: Do not use the NBP cuff on a limb with an intravenous infusion or arterial catheter in place. This could cause tissue damage around the catheter when the infusion is slowed or blocked during cuff inflation.Skin Damage: Do not measure NBP in cases of sickle-cell disease or any condition where skin damage has occurred or is expected.Existing Wounds: Do not apply the cuff over a wound as this can cause further injury.Mastectomy: Avoid applying the cuff on the side of the mastectomy, as the pressure increases the risk of lymphedema. For patients with a bilateral mastectomy, use clinical judgement to decide whether the the benefit of the measurement outweighs the risk.
22 Monitoring Noninvasive Blood Pressure236Unattended Measurement: Use clinical judgement to decide whether to perform frequent unattended blood pressure measurements. Too frequent measurements can cause blood flow interference potentially resulting in injury to the patient. In cases of severe blood clotting disorders frequent measurements increase the risk of hematoma in the limb fitted with the cuff.Temporary Loss of Function: The pressurization of the cuff can temporarily cause loss of function of monitoring equipment used simultaneously on the same limb.Measurement LimitationsNBP readings can be affected by the position of the subject, their physiological condition, the measurement site, and physical exercise. Thus a physician must determine the clinical significance of the NBP information.The measurement may be inaccurate or impossible:• with excessive and continuous patient movement such as during contractions• if a regular arterial pressure pulse is hard to detect• with cardiac arrhythmias• with rapid blood pressure changes• with severe shock or hypothermia that reduces blood flow to the peripheries• with obesity, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery• on an edematous extremityMeasurement MethodsThere are three measurement methods:•Manual - measurement on demand. Results are displayed for up to one hour.•Auto - continually repeated measurements (between one and 120 minute adjustable interval). You can make a manual measurement between two measurements in Auto Mode.•Sequence- up to four measurement cycles which run consecutively, with a number of measurements and intervals between them configurable for each cycle.Reference MethodThe measurement reference method can be Auscultatory (manual cuff) or Invasive (intra-arterial). For further information, see the Application Note supplied on the monitor documentation DVD.To check the current setting, select Main Setup, Measurements, NBP, and check whether the Reference setting is set to Auscultatory or Invasive. This setting can be changed in Configuration Mode.
22 Monitoring Noninvasive Blood Pressure237Preparing to Measure Noninvasive Blood PressureIf possible, avoid taking measurements during contractions, because the measurement may be unreliable, and may cause additional stress for the patient.1Connect the cuff to the air tubing.2Plug the air tubing into the red NBP connector. Avoid compression or restriction of pressure tubes. Air must pass unrestricted through the tubing.WARNINGKinked or otherwise restricted tubing can lead to a continuous cuff pressure, causing blood flow interference, and potentially resulting in injury to the patient.3Make sure that you are using a Philips-approved correct sized cuff, and that the bladder inside the cover is not folded or twisted.A wrong cuff size, and a folded or twisted bladder, can cause inaccurate measurements. The width of the cuff should be in the range from 37% to 47% of the limb circumference. The inflatable part of the cuff should be long enough to encircle at least 80% of the limb.4Apply the cuff to a limb at the same level as the heart. If it is not, you must use the measurement correction formula to correct the measurement.The marking on the cuff must match the artery location. Do not wrap the cuff too tightly around the limb. It may cause discoloration, and ischemia of the extremities.WARNINGInspect the application site regularly to ensure skin quality and inspect the extremity of the cuffed limb for normal color, warmth, and sensitivity. If the skin quality changes, or if the extremity circulation is being affected, move the cuff to another site, or stop the blood pressure measurements immediately. Check more frequently when making automatic measurements.Correcting the Measurement if Limb is not at Heart LevelTo correct the measurement if the limb is not at heart level, to the displayed value:Recommendations For Measurements Used in Diagnosis of HypertensionTo make a measurement for use in the diagnosis of hypertension, follow the steps below:1Ensure the patient is comfortably seated, with their legs uncrossed, feet flat on the floor, and back and arm supported.2Ask the patient to relax and not talk before and during the measurement.3If possible, wait 5 minutes before making the first measurement.Add 0.75 mmHg (0.10 kPa) for each centimeter higher orDeduct 0.75 mmHg (0.10 kPa) for each centimeter lower orAdd 1.9 mmHg (0.25 kPa) for each inch higher. Deduct 1.9 mmHg (0.25 kPa) for each inch lower.
22 Monitoring Noninvasive Blood Pressure238Understanding the NumericsDepending on the numeric size, not all elements may be visible. Your monitor may be configured to display only the systolic and diastolic values. If configured to do so, the pulse from NBP is displayed with the NBP numeric.Aging NumericsThe measured NBP value, together with the corresponding pulse rate, if this is switched on, are displayed for one hour. After that the values are regarded as invalid and are no longer displayed. During this time, measurement values may be grayed out, or disappear from the screen after a set time, if configured to do so. This avoids older numerics being misinterpreted as current data. The time can be set in Configuration Mode. In Auto Mode, the measurement values may disappear more quickly (to be replaced by new measurement values), if the repeat time is set to less than one hour.Alarm SourcesIf you have parallel alarm sources, the sources are displayed instead of the alarm limits.NBP Measurement TimestampDepending on your configuration, the time shown beside the NBP numeric can be:– the time of the most recent NBP measurement, also known as the "timestamp", or– the time until the next measurement in an automatic series, displayed with a graphic representation of the remaining time, as shown here.• The NBP timestamp will normally show the completion time of the NBP measurement.NBP Measurement Start TimeIn Auto or Sequence mode, the monitor is configured to synchronize the measurements in a measurement series to an "easy-to-document" time. For example, if you start the first measurement at 08:23, and the Repeat Time is set to 10 min, the monitor automatically performs the next measurement at 8:30, then 8:40, and so on, unless it has been configured to NotSynchron..During MeasurementsThe cuff pressure is displayed instead of the units and the repeat time. An early systolic value gives you a preliminary indication of the systolic blood pressure during measurement.1Alarm source2Measurement Mode3Timestamp/Timer4Mean pressure5Diastolic6Systolic7Alarm limits
22 Monitoring Noninvasive Blood Pressure239Starting and Stopping MeasurementsUse the setup menu or the SmartKeys to start and stop measurements.Enabling Automatic Mode and Setting Repetition Time1In the Setup NBP menu, select Mode.2Switch between Auto and Manual, if necessary, to pick the measurement method.3If making an automatic measurement, select Repeat Time, or press the Repeat Time SmartKey and set the time interval between two measurements.NOTEBe aware that a combination of a recorder speed of less than 3 cm/min and a repetition time of less than five minutes can result in not all noninvasive blood pressure measurements being recorded on the fetal trace. For example, if the recorder speed is set to 1 cm/min and the repetition time is set to two minutes, due to the low speed setting, the recorder will only be able to record every other noninvasive blood pressure measurement. This affects only the local fetal trace recording, and all measurements are displayed as normal on the monitor's screen.Action to be performed Setup menu SmartKeysStart/Stop manual measurementStart Auto seriesStop current automatic measurementStart/StopStart/ StopStart manual measurementStart Auto series-Start NBPStop manual measurementStop current automatic measurement-Stop NBPStop automatic, or manual measurement AND seriesStop All NBPStop All
22 Monitoring Noninvasive Blood Pressure240Enabling Sequence Mode and Setting Up the Sequence1In the Setup NBP menu, select Mode and select Sequence from the pop-up menu.2Select Setup Sequence to open the Setup Sequence window.Up to four measurement cycles can be set up which run consecutively. For each cycle, you can set the number of measurements and the intervals between them. If you want to run fewer than four cycles in a sequence, you can set the number of measurements for one or more cycles to Off.3Select each sequence in turn, and select the number of measurements and the time interval between the measurements.4To have measurements continue after the sequence, set the number of measurements for your last cycle to Continuous and this cycle will run indefinitely.CAUTIONBe aware that, if none of the cycles are set to Continuous, NBP monitoring will end after the last measurement of the cycle.When the NBP measurement mode is set to Sequence, the repetition time for Auto Mode cannot be changed.Choosing the Alarm SourceYou can monitor for alarm conditions in systolic, diastolic, and mean pressure, either singly or in parallel. Only one alarm is given, with the priority of mean, systolic, diastolic.If mean is not selected as alarm source (Sys., Dia., or Sys & Dia selected), but the fetal monitor can only derive a mean value, mean alarms will nevertheless be announced using the most recent mean alarm limits. Check that the mean alarm limits are appropriate for the patient, even when not using mean as the alarm source. When no value can be derived, an NBP Measure Failed INOP is displayed.Menu option Pressure value monitoredSys.systolicDia.diastolicMeanmeanSys & Diasystolic and diastolic in parallelDia & Meandiastolic and mean in parallelSys & Meansystolic and mean in parallelSys&Dia&Meanall three pressures in parallel
22 Monitoring Noninvasive Blood Pressure241Assisting Venous PunctureYou can use the cuff to cause subdiastolic pressure. The cuff deflates automatically after a set time if you do not deflate it.1In the Setup NBP menu, select VeniPuncture.2Puncture vein and draw blood sample.3Reselect VeniPuncture to deflate the cuff.During measurement, the display shows the inflation pressure of the cuff and the remaining time in venous puncture mode.Calibrating NBPNBP is not user-calibrated. NBP pressure transducers must be verified at least once every two years by a qualified service professional, and calibrated, if necessary. See the Service Guide for details.1Cuff pressure2Venous puncture measurement mode3Time left in venous puncture mode
22 Monitoring Noninvasive Blood Pressure242TroubleshootingProblem Possible Causes SolutionsCuff will not inflate Monitor is in Service or Configuration ModeTechnical defect Call serviceCuff tubing not connected Connect cuff tubingHigh or low values measured (against clinical expectations)Contraction occurring Wait until contraction has finishedPatient talking before or during measurementAllow patient to rest quietly, then try again after three to five minutesIncorrect cuff size or cuff not at heart levelCheck cuff size, level, and positionNoninvasive blood pressure reference method set incorrectlyCheck the reference method configured (auscultation or intra-arterial) and correct if necessary in Configuration ModeMeasurement limitations have not been taken into accountCheck the list in “Measurement Limitations” on page 236Displays zeros for systolic and diastolic values. Measurement automatically repeatsSevere vasoconstriction at cuff site Move cuff to another limb, check for shock, or verify blood pressure using another methodErratic blood pressure fluctuations due to arrhythmias or rapid-acting drugs or contractionsTry again, if unsuccessful, verify blood pressure using another methodWait until contraction has finishedExcessive patient movement or convulsionsRestrain movement or verify blood pressure using another methodNBP Cuff Overpress INOP is displayedSee “Patient Alarms and INOPs” on page 129.NBP Equip Malf INOP is displayedNBP Interrupted INOP is displayedNBP Measure Failed
2324323Monitoring SpO2FM30/40/50 The pulse oximetry measurement (SpO2) is intended for use with maternal patients.Philips pulse oximetry uses a motion-tolerant signal processing algorithm, based on Fourier Artifact Suppression Technology (FAST). It provides two measurements:• Oxygen saturation of arterial blood (SpO2) - percentage of oxygenated hemoglobin in relation to the sum of oxyhemoglobin and deoxyhemoglobin (functional arterial oxygen saturation).• Pulse rate - detected arterial pulsations per minute. This is derived from the SpO2 value, and is one of four sources of the maternal heart/pulse rate used for cross-channel verification (see “Monitoring Maternal Heart / Pulse Rate” on page 221 and “Cross-Channel Verification (CCV)” on page 159).Selecting an SpO2 SensorSee “Accessories and Supplies” on page 275 for a list of sensors, and the patient population and application sites for which they are appropriate.Familiarize yourself with the Instructions for Use supplied with your sensor before using it.CAUTIONDo not use OxiCliq disposable sensors in a high humidity environment, or in the presence of fluids, which may contaminate sensor and electrical connections causing unreliable or intermittent measurements. Do not use disposable sensors when there is a known allergic reaction to the adhesive.Applying the Sensor1Follow the SpO2 sensor's Instructions for Use, adhering to all warnings and cautions.2Remove colored nail polish from the application site.3Apply the sensor to the patient. The application site should match the sensor size so that the sensor can neither fall off, nor apply excessive pressure.4Check that the light emitter and the photodetector are directly opposite each other. All light from the emitter must pass through the patient's tissue.
23 Monitoring SpO2244WARNINGCompatibility: Use only the accessories that are specified for use with this fetal monitor, otherwise patient injury can result.Proper Sensor Fit: If a sensor is too loose, it might compromise the optical alignment or fall off. If it is too tight, for example because the application site is too large or becomes too large due to edema, excessive pressure may be applied. This can result in venous congestion distal from the application site, leading to interstitial edema, hypoxemia, and tissue malnutrition. Skin irritations or lacerations may occur as a result of the sensor being attached to one location for too long. To avoid skin irritations and lacerations, periodically inspect the sensor application site and change the application site regularly.Venous Pulsation: Do not apply sensor too tightly as this results in venous pulsation which may severely obstruct circulation and lead to inaccurate measurements.Ambient Temperature: At elevated ambient temperatures, be careful with measurement sites that are not well perfused, because this can cause severe burns after prolonged application. All listed sensors operate without risk of exceeding 41°C on the skin if the initial skin temperature does not exceed 35°C.Extremities to Avoid: Avoid placing the sensor on extremities with an arterial catheter, an NBP cuff, or an intravascular venous infusion line.Connecting SpO2 CablesConnect the sensor cable to the color-coded socket on the monitor. If you are using a disposable sensor, plug the sensor into the adapter cable and connect this to the monitor. Connect reusable sensors directly to the monitor.CAUTIONExtension cables: Do not use more than one extension cable (M1941A). Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "long" cable version).Electrical Interference: Position the sensor cable and connector away from power cables, to avoid electrical interference.Measuring SpO2During measurement, ensure that the application site:– has a pulsatile flow, ideally with a signal quality indicator of at least medium.– has not changed in its thickness (for example, due to edema), causing an improper fit of the sensor.
23 Monitoring SpO2245WARNING• For fully conscious maternal patients, who have a normal function of perfusion and sensory perception at the measurement site:To ensure skin quality and correct optical alignment of the sensor, inspect the application site when the measurement results are suspicious, or when the patient complains about pressure at the application site, but at least every 24 hours. Correct the sensor alignment if necessary. Move the sensor to another site, if the skin quality changes.• For all other patients:Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. Correct the sensor alignment if necessary. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours.• Injected dyes such as methylene blue, or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements.• Inaccurate measurements may result when the application site for the sensor is deeply pigmented or deeply colored, for example, with nail polish, artificial nails, dye, or pigmented cream.• Interference can be caused by:– High levels of ambient light (including IR warmers), or strobe lights or flashing lights (such as fire alarm lamps). (Hint: cover application site with opaque material).– Another SpO2 sensor in close proximity (e.g. when more than one SpO2 measurement is performed on the same patient). Always cover both sensors with opaque material to reduce cross-interference.– Electromagnetic interference, especially when the signal quality indicator is below medium.– Excessive patient movement and vibration.SpO2 Signal Quality Indicator (FAST SpO2 only)The SpO2 numeric is displayed together with a signal quality indicator (if configured and enough space is available) which gives an indication of the reliability of the displayed values.The level to which the triangle is filled shows the quality of the signal; the indicator below shows a medium signal quality. The signal quality is at a maximum when the triangle is completely filled.
23 Monitoring SpO2246Assessing a Suspicious SpO2 ReadingTraditionally, pulse rate from SpO2 was compared with heart rate from ECG to confirm the validity of the SpO2 reading. With newer algorithms, such as FAST-SpO2, this is no longer a valid criteria because the correct calculation of SpO2 is not directly linked to the correct detection of each pulse.When the pulse rate is very low, or strong arrhythmia is present, the SpO2 pulse rate may differ from the heart rate calculated from ECG, but this does not indicate an inaccurate SpO2 value.WARNINGWith pulse oximetry, sensor movement, ambient light (especially strobe lights, or flashing lights), or electromagnetic interference can give unexpected intermittent readings when the sensor is not attached. Especially bandage-type sensor designs are sensitive to minimal sensor movement that might occur when the sensor is dangling.Understanding SpO2 AlarmsThis refers to SpO2 specific alarms. See the “Alarms” on page 117 chapter for general alarm information. SpO2 offers high and low limit alarms, and a high priority desat alarm. You cannot set the low alarm limit below the desat alarm limit.CAUTIONIf you measure SpO2 on a limb that has an inflated noninvasive blood pressure cuff, a non-pulsatile SpO2 INOP can occur. If the fetal monitor is configured to suppress this alarm, there may be a delay of up to 60 seconds in indicating a critical status, such as sudden pulse loss or hypoxia.Alarm DelaysThere is a delay between a physiological event at the measurement site and the corresponding alarm at the monitor. This delay has two components:• The general system delay time is the time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing and the averaging time.• The time between the displayed numerical values crossing an alarm limit and the alarm indication on the monitor. This delay is the combination of the configured alarm delay time plus the general system alarm signal delay time.Adjusting the SpO2 Alarm LimitsIn the Setup SpO menu:•Select High Limit then choose the upper alarm limit.•Select Low Limit then choose the lower alarm limit.
23 Monitoring SpO2247Adjusting the Desat Limit AlarmThe Desat alarm is a high priority (red) alarm notifying you of potentially life threatening drops in oxygen saturation.1In the Setup SpO menu, select Desat Limit.2Adjust the limit.Adjusting the Pulse Alarm LimitsSee “Adjusting the Heart Rate / Pulse Alarm Limits” on page 228.Setting Up Tone ModulationIf tone modulation is on, the QRS tone pitch lowers when the SpO2 level drops. Remember, the QRS tone is derived from either heart rate (from MECG or the CL F&M Pod) or pulse (from built-in SpO2) depending on which is currently displayed (see “Priority for Maternal Heart / Pulse Rate” on page 221).NOTEPulse from CL SpO2 and Toco MP does not provide a QRS tone.Setting the QRS VolumeIn the Setup SpO menu, select QRS Volume and set the appropriate QRS tone volume.
23 Monitoring SpO2248
2424924Monitoring Maternal TemperatureMeasuring Tympanic TemperatureThe tympanic thermometer (866149) measures the patient's temperature in the ear using infrared technology.The result of this measurement can be automatically adjusted to correspond to a different body reference site. The result is displayed on the screen of the thermometer and transmitted to the monitor.The thermometer is used with single-use probe covers for infection control during measurement.WARNINGDo not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
24 Monitoring Maternal Temperature250Place the thermometer into its base station, when it is not in use. The base station allows flexible mounting of the thermometer at the point of care. The base station is connected to the monitor's MIB/RS232 interface (optional) with a cable. It has storage space for up to 32 probe covers.Thermometer Display and ControlsThe tympanic thermometer has a liquid crystal display. The display shows the patient's temperature in numerics and guides you with symbols through the measurement process.1Base station2Thermometer1Eject key2Change unit key: °Celsius/°Fahrenheit3Start measurement key4Pulse timer keyFunctional Keys Description of UsePress the eject key to eject the probe cover. The eject key symbol is shown on the display when a measurement has been taken and transmitted.Press the change unit key after a measurement to switch between °C and °F (only affects the handheld device and not the monitor numerics).
24 Monitoring Maternal Temperature251Status ScreensThe thermometer performs an internal test at every start-up to verify that the system components are functioning properly. It measures the ambient temperature. During start-up and measurement, the thermometer screens communicate the current status.Press the start measurement key when you are ready to take a patient's temperature.The pulse timer key can be used to time vital signs you take manually.The pulse timer only functions after you have taken a temperature measurement.Press and hold the pulse timer key to enter timer mode. Press the pulse timer key again to start the timer.The thermometer will issue a one beep at 15 seconds, two beeps at 30 seconds, three beeps at 45 seconds, and four beeps at 60 seconds.Functional Keys Description of UseImages Description Ambient temperature above specified rangeAmbient temperature below specified rangeSystem errorsSystem error 12 - there is a problem with the settings. Contact your service personnel to have them check the settings and reset them, if necessary.If the display shows any other system error, then reset the thermometer by picking up a probe cover. If the system error does not clear, contact your service personnel.
24 Monitoring Maternal Temperature252Making a Temperature MeasurementWARNINGInaccurate measurement results can be caused by:• incorrect application of the thermometer• anatomical variations in the ear• build up of earwax in the ear• excessive patient movement during the measurement• absent, defective, or soiled probe covers• probe covers other than the specified probe covers• external environment temperature outside the range of 16ºC-33ºC (60.8ºF-91.4ºF)1Ensure that the base station is connected with the appropriate cable to the connector on the monitor.2Remove the thermometer from the base station.The thermometer is latched to the base station to avoid an accidental fall when the base station is moved. To pick up the thermometer from the base station move it slightly up, and then lift it from the base station to release the latch.3Press the eject key on the thermometer to discard any probe that may have been left on the thermometer from a previous use.4Pick up a new probe cover from the container on the base station.5Inspect the probe cover to make sure that it is fully seated (no space between cover and tip base) and that there are no holes, tears, or wrinkles in the plastic film.6Place the thermometer with the probe in the ear canal, sealing the opening with the probe tip. For consistent results, ensure that the probe shaft is aligned with the ear canal.7Press and release the start-up key gently.8Wait until you hear the three beeps.9Remove the probe from the ear.The temperature values are displayed both on the thermometer itself, and on the connected monitor.10 Check that the correct temperature label for the measurement site is displayed: iTrect, iToral, iTcore, or iTtymp.11 Press the eject key to eject the probe cover into a suitable waste receptacle.12 Return the thermometer to the base station.The thermometer switches to stand-by mode after 30 seconds when it is not used.
24 Monitoring Maternal Temperature253Possible INOPsWARNING• Never apply the probe to the patient when the thermometer is not connected to the base station.• Always use a single-use probe cover to limit patient cross-contamination.• Measurement errors or inaccurate readings may result when probe covers other than the specified probe covers are used (see “Tympanic Temperature Accessories” on page 285).• Insert the probe slowly and carefully to avoid damage to the ear canal and the tympanic membrane.• Inspect the probe cover for damage, holes, tears, or sharp edges to avoid injuring the skin.• Always ensure that the used probe cover is removed before attaching a new probe cover.CAUTION• Do not immerse the probe in fluids, or drop fluids on the probe.• Do not use a probe cover that has been dropped or is damaged.• Do not autoclave. To prevent damage to the base station, thermometer and accessories, refer to the cleaning procedures in the “Care and Cleaning” on page 261 chapter.WARNINGIf you have dropped the base station or thermometer, or if the unit has been stored below -25°C or above 55°C, have service personnel test the unit for proper functions, and calibrate the unit before further use.The Value Lifetime (length of time the entered value is shown on the screen) can be configured in Configuration Mode.Images DescriptionPatient temperature above measurement range.Patient temperature below measurement range.
24 Monitoring Maternal Temperature254Body Reference Sites and Monitor LabelsThe tympanic thermometer measures the patient's temperature in the ear. The thermometer can be configured to adjust the result of the measurement to correspond to a different body reference site. The measurement label displayed on the monitor corresponds to the body reference site that is configured. The following body reference sites are available:The body reference site can be selected in the Biomed mode of the tympanic thermometer. Refer to the Service Guide for more information.The measured maternal temperature is only transmitted to a connected OB TraceVue/IntelliSpace Perinatal system, when the tympanic thermometer is configured to the iTtymp body reference site, and the iTtymp label is displayed on the fetal monitor screen, and printed on the trace.Entering Temperature ManuallyA temperature measurement can be entered manually.1Press the SmartKey Enter Temp (configurable)or select the SmartKey Main Setup, then select Measurements, Enter Temp. A numeric pad opens.2Enter the temperature values.3Select the Enter key.IntervalUse the Interval setting to define the time after which a manually entered temperature value becomes invalid (no value is then displayed).NOTEA manually entered temperature has to be 25ºC or higher to be transmitted to a connected obstetrical information and surveillance system.Body Reference Site Label on MonitorEar temperature (no adjustment)iTtympOral temperatureiToralCore temperatureiTcoreRectal temperature iTrect
2525525Paper Save Mode for Maternal MeasurementsYour monitor's recorder features a Paper Save Mode, where maternal vital signs are recorded using less paper than during a normal trace recording.When Paper Save Mode is enabled, and if the recorder is stopped, it will start automatically to print data from maternal measurements as they occur, and then stops again to save paper. You enable Paper Save Mode in Configuration Mode (default is off).• A header is printed first before the measurements are recorded. A new header is also printed when there is a date change at midnight.• Each NBP measurement is recorded. The time when the measurement ended is recorded.• Each Temperature measurement is recorded. The time when the measurement ended is recorded.• Other maternal parameters (SpO2, maternal heart rate, or Pulse) are recorded every five minutes. The rules described in the section “Priority for Maternal Heart / Pulse Rate” on page 221 apply.• Paper Save Mode recording stops if there are no valid maternal measurements for more than one hour, and a message will notify you that there are no active parameters. Paper Save Mode recording will restart automatically when another valid measurement is made.Event Paper Save Mode ReactivationOne of the maternal measurements (see above) is valid again. yesThe recorder is turned off and on again or a report has been recorded (e.g. NST Report).yesThe Paper Advance function is used. yesThe Paper Save Mode setting is set off and on again. yesADT information has changed (e.g. because patient information has been completed or updated).noThe monitor is restarted (e.g. by switching it off and on again). yesThe date has changed (e.g. at midnight). no
25 Paper Save Mode for Maternal Measurements256
2625726Recovering DataThe monitor stores trace data, including annotations, for a minimum of 3.5 hours with the software revision J.3 or higher, and for a minimum of 7 hours with the new mainboard hardware revision A 00.18, in its internal backup memory. This allows the monitor to recover trace data that would otherwise be lost under certain circumstances. In the event of the paper running out, this trace recovery data can be automatically retrieved and printed, or automatically transmitted to an OB TraceVue/IntelliSpace Perinatal system (LAN connection only), allowing continuity of data.The fetal trace printed from the trace recovery data contains all data from the real-time trace.Note that the data in the memory is cleared when a software upgrade is performed.CAUTIONOnly use Philips paper. Using paper other than Philips paper may result in the failure to recover traces.Recovering Traces on PaperThe monitor is able to recover traces by printing them out at a high speed from the monitor's backup memory. If the monitor runs out of paper, or if the paper drawer is open, the exact time when this happens is stored in the backup memory. If the Bridge Paperout setting is set to On (default), when new paper is loaded and the recorder is started, a trace recovery printout of the data recovered from the backup memory is automatically printed out at high speed (up to 20 mm/s), starting from the time noted in the backup memory. This ensures that no data is lost. A minimum of one hour of trace recovery data is available for printing out from the backup memory. When the trace recovery printout has finished, the recorder automatically switches back to continue recording the current trace at the normal speed.Note the following:• If you press the fetal recorder Start/ Stop SmartKey during a trace recovery printout, the recording stops, and the next recording following a recorder restart will be a normal, real-time trace.After switching off the monitor, and then back on again, or following a power failure, the time of the last Check Paper INOP or paper-out detection is lost, and therefore any trace recovery data in the backup memory is no longer available to print. The next recording made following a restart of the recorder is a normal, real-time trace.
26 Recovering Data258• The change back to a real-time recording from a trace recovery printout prompts the recording to restart. A new vertical trace header annotation consisting of the time, date, and recorder speed is printed, letting you see where the trace recovery printout ends, and where the real-time trace continues.• There can be a gap of up to 30 seconds between the trace recovery printout, and the beginning of the real-time trace.Recovering Traces on an OB TraceVue/IntelliSpace Perinatal SystemThe trace recovery data stored in the monitor's backup memory can also be uploaded at high speed to an OB TraceVue/IntelliSpace Perinatal system connected over the LAN interface (OB TraceVue Revision E.00.00 or later, and IntelliSpace Perinatal H.0 or later).When the OB TraceVue/IntelliSpace Perinatal system reconnects to the fetal monitor and detects that there is trace recovery data in the monitor's backup memory that has not yet been transmitted to the system, this data is transferred at high speed to the system. No user action is required.The exact length of the recovered trace will vary depending on the amount of trace information, but it will cover at least 3.5 hours of trace data with the software revision J.3 or higher, and 7 hours with the new mainboard hardware revision A 00.18, depending on the number of active parameters.To recover traces on an OB TraceVue/IntelliSpace Perinatal system, the following applies:• The trace data in the monitor's internal memory must relate to a specific patient in the OB TraceVue/IntelliSpace Perinatal system. In other words, there were no discharge events made on the monitor that would change the patient context.• The patient must have an open episode. No data will be uploaded if the patient is not admitted to OB TraceVue/IntelliSpace Perinatal. For further details see the OB TraceVue/IntelliSpace Perinatal Instructions for Use.• Current online trace data is held back until the fast upload is complete.Manually Recording Stored DataIf the recorder is not running, you can choose to print trace data from the monitor's memory at any time. You can see a list of all stored traces, showing patient identification and trace period, in the Stored Data Recording window, from which you can choose one of the entries at a time.CAUTIONEnsure that you admit each patient by name, including other patient identification information, and discharge the patient when you have finished monitoring, so that you can identify which trace period (entry in the patient list) refers to which patient.Trace storage can be triggered by:• Discharging a patient• Powering on the monitor• Entering Standby• Entering Service Mode
26 Recovering Data259Traces are not available for periods the monitor was switched off, in Service Mode, in Standby, or if the trace period was shorter than one minute.The speed of the printout depends on the configured recorder speed and on the amount of trace data available. The fetal trace printed from the trace data contains all data from the real-time trace, with the exception of the maternal heart rate, the pulse numeric, and the ECG wave.Information for scale type, trace separation, and recorder speed are not stored in the trace memory, but is applied when the stored recording starts. While the stored recording is printing, all functions are disabled, except that for stopping the recorder.To start a stored data recording:Either1Select the Stored Data Rec SmartKey.2Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data).Or1Enter the Main Setup menu using the SmartKey.2Select Fetal Recorder to open the Fetal Recorder menu.3Select Stored Data Rec to open the Stored Data Recording window.4Select an entry for a patient.5Select All to print all stored trace data for the selected entry, or select one of the choices on the other pop-up keys to print only a specified portion of the entry (for example, Last 15 min for the last 15 minutes of trace data).To delete all stored trace periods:Either1Select the Stored Data Rec SmartKey.2Select the Erase All key to delete all stored trace periods listed.3Select the Confirm key.Or1Enter the Main Setup menu using the SmartKey.2Select Fetal Recorder to open the Fetal Recorder menu.3Select Stored Data Rec to open the Stored Data Recording window.4Select the Erase All key to delete all stored trace periods listed.5Select the Confirm key.
26 Recovering Data260The current patient’s entry is at the top of the list. The oldest entry at the bottom of the list has no start time specified, as part of the data originally stored may have been over-written by the current patient’s data.It may be that you only see one entry (the current patient’s data) in the Stored Data Recording window if that patient was monitored for a period long enough to erase any earlier entries.If you make a stored data recording for an old entry (that is, not for the current patient), the recorder performs a fast trace printout of the stored data, advances the paper to the next paper fold, then stops.If you make a stored data recording for the current patient, the recorder performs a fast trace printout of the stored data, and then reverts automatically to recording the real-time trace.
2726127Care and CleaningUse only the Philips-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods.Philips makes no claims regarding the efficacy of the listed chemicals, or methods as a means for controlling infection. Consult your hospital’s Infection Control Officer or Epidemiologist. For comprehensive details on cleaning agents and their efficacy refer to “Guideline for Disinfection and Sterilization in Healthcare Facilities” issued by the U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, Atlanta, Georgia, 2008. See also any local policies that apply within your hospital, and country.General PointsThe transducers and patient modules are sensitive instruments. Handle them with care.Keep your monitor, transducers, patient modules, cables, and accessories free of dust and dirt. After cleaning and disinfection, check the equipment carefully. Do not use if you see signs of deterioration or damage. If you need to return any equipment to Philips, always decontaminate it first before sending it back in appropriate packaging.Observe the following general precautions:• Always follow carefully and retain the instructions that accompany the specific cleaning and disinfecting substances you are using.• Always dilute cleaning agents according to the manufacturer's instructions or use lowest possible concentration.• Do not allow liquid to enter the case.• Do not immerse the monitor in liquid. Protect it against water sprays or splashes.• Do not pour liquid onto the system.• Never use abrasive material (such as steel wool or silver polish).• Never use bleach.
27 Care and Cleaning262WARNING• Do not operate the monitor if it is wet. If you spill liquid on the monitor, contact your service personnel or Philips service engineer.• Do not perform underwater monitoring (for example, in a bath or shower) using wired transducers.• Place the monitor where there is no chance of contact with, or falling into water or other liquid.• Do not dry equipment using heating devices such as heaters, ovens (including microwave ovens), hair dryers, and heating lamps.• Do not put equipment or accessories in autoclave (for sterilization).Cleaning and DisinfectingClean and disinfect the Avalon FM20, FM30, FM40, and FM50 fetal monitors and the transducers M2734A, M2734B, M2735A, M2736A, and M2738A (including ECG adapter cables) and the Avalon CL base station and the cableless transducers after each use. Clean equipment before disinfecting. For other accessories, see “Cleaning and Disinfecting Monitoring Accessories” on page 263.Clean with a lint-free cloth, moistened with warm water (40°C/104°F maximum) and soap, a diluted non-caustic detergent, tenside, or phosphate-based cleaning agent. Do not use strong solvents such as acetone or trichloroethylene. After cleaning, disinfect using only the approved disinfecting agents listed (see “Recommended Disinfectants” on page 263).CAUTIONSolutions: Do not mix disinfecting solutions (such as bleach and ammonia) as hazardous gases may result.Hospital policy: Disinfect the product as determined by your hospital's policy, to avoid long-term damage to the product.Local requirements: Observe local laws governing the use of disinfecting agents.Touch display: To clean and disinfect the touch-enabled display, disable the touch operation by switching off the monitor during the cleaning procedure, or by selecting and holding the Main Screen key until the padlock symbol appears on it, indicating that touch operation is disabled. Select and hold again to re-enable touch operation.WARNINGSkin contact: To reduce the risk of skin irritations, do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces - wipe it off with a cloth dampened with water, after allowing the appropriate time for the agent to work. Follow the safety instructions of the used cleaning or disinfection agent, especially regarding skin contact.
27 Care and Cleaning263Take extra care when cleaning the screen of the monitor, because it is more sensitive to rough cleaning methods than the housing. Do not permit any liquid to enter the monitor case and avoid pouring it on the monitor while cleaning. Do not allow water or cleaning solution to enter the measurement connectors. Wipe around and not over connector sockets, or those of the Toco+, CL Toco+ MP transducer, ECG and IUP Patient Modules, CL ECG/IUP transducer and adapter cables.Wash soiled reusable belts with soap and water. Water temperature must not exceed 60°C/140°F.Recommended DisinfectantsWe recommend that you use one of the following disinfectants:Cleaning and Disinfecting Monitoring AccessoriesTo clean, disinfect and sterilize reusable transducers, sensors, cables, leads, and so forth, refer to the instructions delivered with the accessory.Do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces. Wipe residues off, after allowing the appropriate time to for the agent to work, with a cloth.Product Name Product Type IngredientsIsopropanol liquid Isopropanol 80%Bacillol® AF liquid, spray 100 g concentrate contains: Propan-1-ol 45.0 gPropan-2-ol 25.0 gEthanol 4.7 gBacillol®25 liquid Ethanol 100 mg/gPropan-2-ol (= 2-Propanol) 90 mg/gPropan-1-ol (= 1-Propanol) 60 mg/gMeliseptol® spray 50% 1-PropanolAccel TB RTU liquid 0.5% accelerated hydrogen peroxideOxivir® Tb Cleaner Disinfectant spray 0.5% accelerated hydrogen peroxideOxivir® Tb Wipes wipes 0.5% accelerated hydrogen peroxideCarpe DiemTM/MC TbReady-to-Use General Virucide, Bactericide, Tuberculocide, Fungicide, Sanitizerspray 0.5% accelerated hydrogen peroxideCarpe DiemTM/MC Tb Wipes wipes 0.5% accelerated hydrogen peroxideSuper Sani-ClothGermicidal Disposable Wipeswipes Isopropanol 55%quaternary ammonium chlorides 0.5%SANI-CLOTH® PLUSGermicidal Disposable Wipeswipes Isopropanol 15%quaternary ammonium chlorides 0.25%SANI-CLOTH® HB GermicidalGermicidal Disposable Wipeswipes Isopropanol < 0.15%quaternary ammonium chlorides 0.14%
27 Care and Cleaning264Cleaning and Disinfecting the Tympanic Temperature AccessoriesProbe and Thermometer Body1Wipe the thermometer body clean with a damp cloth. The water temperature should not exceed 55°C (130°F). Do not soak, rinse, or submerge the thermometer under water.You may add a mild detergent to the water.2Clean the probe tip with a lint free swab. If the probe tip is soiled, clean it with a dampened swab.3After you have removed all foreign matter, clean the thermometer lens at the end of the probe tip with a lint free swab or lens wipe. The thermometer lens must be free from fingerprints and/or smudges for proper operation.4Thoroughly dry all surfaces before using the equipment.CAUTIONDo not use cleaners and disinfectants such as Spray-Nine™, Phisohex™, Hibiclens™, or Vesta-Syde™ as they may result in damage to the thermometer case.Occasional use of a 10:1 water and hypochlorite mixture or a damp isopropyl alcohol wipe or Cidex™ or ManuKlenz™ or VIROX™ or CaviWipes™ cleansing agents is acceptable, however, prolonged or repeated use of these chemicals may result in damage to the thermometer case and display area.Use of a cloth or sponge is recommended for cleaning. Never use an abrasive pad or an abrasive cleaner on the thermometer.The thermometer is non-sterile. Do not use ethylene oxide gas, heat, autoclave, or any other harsh method to sterilize this thermometer.Cleaning and Disinfecting CL Transducers and CL PodsTo clean, disinfect and sterilize reusable CL transducers and CL Pods refer to the instructions delivered with the accessory.Do not allow a cleaning or disinfecting agent to leave residues on any of the equipment surfaces. Wipe residues off, after allowing the appropriate time to for the agent to work, with a cloth damp with water.NOTEPay especially close attention to cleaning and wiping down the gold connection contacts.
27 Care and Cleaning265SterilizingSterilization is not allowed for this monitor, related products, accessories, or supplies unless otherwise indicated in the Instructions for Use that accompany the accessories and supplies.WARNINGDo not put device and accessories in autoclave (for sterilization).
27 Care and Cleaning266
2826728MaintenanceWARNINGSchedule: Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.In case of problems: If you discover a problem with any of the equipment, contact your service personnel, Philips, or your authorized supplier.Electric shock hazard: Do not open the monitor housing. Refer all servicing to qualified service personnel.Inspecting the Equipment and AccessoriesYou should perform a visual inspection before each use, and in accordance with your hospital's policy. With the monitor switched off:1Examine unit exteriors for cleanliness and general physical condition. Make sure that the housings are not cracked or broken, that everything is present, that there are no spilled liquids that may have entered the housing, and that there are no signs of abuse.2Inspect all accessories (transducers, sensors and cables, and so forth). Do not use a damaged accessory.3Switch the monitor on, and make sure the display is bright enough. If the brightness is not adequate, contact your service personnel or your supplier.Batteries Preventive MaintenanceFor the FM20/30 with a battery option, see “Using Batteries” on page 110.
28 Maintenance268Inspecting the Cables and Cords1Examine all system cables, the power plug, and cord for damage. Make sure that the prongs of the plug do not move in the casing. If damaged, replace it with an appropriate power cord.2Inspect the cables, leads, and their strain reliefs for general condition. Make sure there are no breaks in the insulation. Make sure that the connectors are properly engaged at each end to prevent rotation or other strain.3Carry out performance assurance checks as described in the monitor's Service Guide.Maintenance Task and Test ScheduleThe following tasks are for Philips-qualified service professionals. All maintenance tasks and performance tests are documented in detail in the service documentation supplied on the monitor's documentation DVD.Ensure that these tasks are carried out as indicated by the monitor's maintenance schedule, or as specified by local laws, whichever comes sooner. Contact a Philips-qualified service professional, if your monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it.Maintenance and Test Schedule FrequencyVisual Inspection Before each use.Clean and disinfect the equipment After each use.Safety checks according to IEC 60601-1, and where applicable, to national standardsAt least once every two years, or as specified by local laws.After any repairs where the power supply has been replaced (by an authorized service professional).If the monitor has been dropped, it must be repaired/checked by an authorized service agent.Performance assurance for all measurementsAt least once every two years, or if you suspect the measurement values are incorrect.Noninvasive blood pressure calibration At least once every two years, or as specified by local laws.Tympanic Thermometer Calibration Once a year. If the unit is dropped or damaged, or if the unit was stored at less than -25ºC or above 55ºC, check it and calibrate it before further use.Clean the thermal printhead At each paper pack change, or every 500 m of paper run.
28 Maintenance269Recorder MaintenanceRemoving the Paper Guide: FM40/FM50FM40/50 The paper guide is removable, and you can use the recorder without it. When not using the paper guide, ALWAYS tear off the paper along the perforation to avoid possible paper misalignment (see “Tearing Off the Paper” on page 61).To remove the paper guide:1Press the paper eject button to open the paper drawer.
28 Maintenance2702Hinge the transparent paper guide forward.3A protrusion (A) holds paper guide in closed position.
28 Maintenance2714Release the paper guide from one side of the holder.5Then remove the paper guide.
28 Maintenance2726Refitting is a reversal of the removal procedure.Storing Recorder PaperRecorder paper is not intended for long-term archival storage. Another medium should be considered if this is required.Dyes contained in thermal papers tend to react with solvents and other chemical compounds that are being used in adhesives. If these compounds come into contact with the thermal print, the print may be destroyed over time. You can take the following precautionary measures to help avoid this effect:• Store the paper in a cool, dry, and dark place.• Do not store the paper at temperatures over 40°C (104°F).• Do not store the paper where the relative humidity exceeds 60%.• Avoid intensive light (UV light), as this may cause the paper to turn gray, or the thermal print to fade.• Avoid storing the thermal paper in combination with the following conditions:– Papers that contain organic solvents. This includes papers with tributyl and/or dibutyl phosphates, for example recycled paper.– Carbon paper and carbonless copy paper.– Products containing polyvinyl chlorides, or other vinyl chlorides for example (but not exclusively) document holders, envelopes, letter files, divider sheets.– Detergents and solvents, such as alcohol, ketone, ester, and others, including cleaning and disinfecting agents.– Products containing solvent-based adhesives such as (but not exclusively) laminating film, transparent film, or labels sensitive to pressure.To ensure long lasting legibility and durability of thermal printouts, store your documents separately in an air-conditioned place and use:• only plasticizer-free envelopes or divider sheets for protection.• laminating films and systems with water-based adhesives.Using such protective envelopes cannot prevent the fading effect caused by other, external agents.
28 Maintenance273Cleaning the Print HeadTo clean the recorder's thermal print-head:1Switch off the monitor.2Open the paper drawer, and remove the paper if necessary, to gain access to the thermal print head.3Gently clean the thermal print head with a cotton swab, or soft cloth soaked in isopropyl alcohol.NOTEIf the print head is heavily coated with dust or dirt, contact your service personnel to clean it.Returning Equipment for RepairBefore returning equipment for repair:• disinfect and decontaminate the equipment appropriately.• ensure that all patient data has been removed (i.e. that no patient is admitted).FM20/30FM40/50
28 Maintenance274Disposing of the MonitorWARNINGTo avoid contaminating or infecting personnel, the environment, or other equipment, make sure that you disinfect and decontaminate the monitor appropriately before disposing of it in accordance with your country's laws for equipment containing electrical and electronic parts. For disposal of parts and accessories such as thermometers, where not otherwise specified, follow local regulations regarding disposal of hospital waste.You can disassemble the monitor and the transducers as described in the Service Guide. You will find detailed disposal information on the following web page:http://www.healthcare.philips.com/main/about/Sustainability/Recycling/pm.wpdThe Recycling Passports located on the Philips web page contain information on the material content of the equipment, including potentially dangerous materials which must be removed before recycling (for example, batteries and parts containing mercury or magnesium).Do not dispose of waste electrical and electronic equipment as unsorted municipal waste. Collect it separately, so that it can be safely and properly reused, treated, recycled, or recovered.
2927529Accessories and SuppliesAll accessories listed for the fetal monitor may not be available in all geographies. To order parts, accessories, and supplies, consult your local Philips representative for details. For customers in the United States, Australia, and Great Britain you can order at www.philips.com/healthcarestore. All accessories and supplies listed here are reusable, unless indicated otherwise.WARNINGReuse: Disposable accessories and supplies intended for single use, or single patient use only, are indicated as such on their packaging. Never reuse disposable accessories and supplies, such as transducers, sensors, electrodes, and so forth, that are intended for single use, or single patient use only.Approved accessories: Use only Philips-approved accessories.Packaging: Do not use a sterilized accessory if its packaging is damaged.Protection against electric shocks: The transducers and accessories listed in this chapter are not defibrillator proof.Electro-Surgery, Defibrillation and MRI: The fetal/maternal monitors are not intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm can result.Information on LatexAll Philips transducers and accessories are latex-free, unless indicated otherwise in the following tables.Avalon CL Base StationCL Base Station Part NumberAvalon CL Base Station can either be ordered with the option K30 (red connector), or K40 (black connector), or K60 (charging station)866074
29 Accessories and Supplies276TransducersFetal AccessoriesTransducer Part NumberAvalon Toco Transducer M2734AAvalon Toco+ Transducer for Toco, DECG, MECG, or IUP monitoring M2735AAvalon Toco MP Transducer for Toco and Maternal Pulse M2734BAvalon Ultrasound Transducer M2736AAvalon Ultrasound Transducer USA M2736AAECG/IUP Patient Module (for DECG, MECG or IUP) M2738AAvalon CL Toco+ MP Transducerfor use with the Avalon CL base station866075Avalon CL Ultrasound Transducerfor use with the Avalon CL base station866076Avalon CL ECG/IUP Transducerfor use with the Avalon CL base station866077Avalon CL Fetal & Maternal Podfor use with the Avalon CL base station866488Avalon CL Wide Range Podfor use with the Avalon CL base station866487CL SpO2 Podfor use with the Avalon CL base station865215CL NBP Podfor use with the Avalon CL base station865216Remote Event Marker 989803143411Accessory Description Part NumberBelt (reusable, gray, water resistant) 32 mm wide, 15 m roll M4601A60 mm wide, 5 belts M4602A60 mm wide, 15 m roll M4603A50 mm wide, 5 belts M1562BBelt (disposable, yellow, water resistant) 60 mm wide, pack of 100 M2208AUltrasound gel 12 Bottles 40483A5 liter refill (with dispenser) for 40483A Shelf life: 24 months max.40483BBelt buttons (kit of 10) for wired transducers M273xA M1569ABelt Clips for wired Smart Transducers (kit of 6) 989803143401
29 Accessories and Supplies277MECG AccessoriesAvalon CL Connector Caps Connector Caps for Avalon CL Cableless Smart Transducers (kit of 10)989803184841Avalon CL Belt Clip Belt Clip for Avalon CL Cableless Smart Transducers (kit of 10)989803184851Avalon CL Battery Replacement Kit 989803184861Cable Management Kit 989803148841Avalon CL Wide Range Battery Kit 989803196421Kit of 20 Mobile CL Transmitter Cradlesfor use with 866487 Avalon CL Wide Range Pod989803168881Avalon CL Fetal & Maternal Patch (case with 10 each) 989803196341ECG Skin Preparation Paperfor use with the 989803196341 Avalon CL F&M patch10 sheets, with 10 finger-tip sized skin prep pieces per sheet (100 preps per bag)M4606ADECG Accessories: Philips DECG Solution(NOT compatible with QwikConnectPlus Solution accessories)DECG reusable leg plate adapter cable (with flushing port)989803137651DECG leg attachment electrode for DECG leg plate adapter cable989803139771DECG fetal scalp electrode: single spiral, worldwide availability989803137631DECG fetal scalp electrode: double spiral, Europe only. Not for USA989803137641Disposable Koala IUP catheter M1333AReusable Koala IUP adapter cable 989803143931Accessory Description Part NumberAccessory Part NumberMECG reusable adapter cable M1363AFoam ECG electrodes, snap-fit, for MECG Adapter Cable (disposable) 40493D/E
29 Accessories and Supplies278Noninvasive Blood Pressure AccessoriesThe following accessories are approved for use with the fetal monitor:Adult Multi Patient Reusable Comfort CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Multi Care Reusable CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult EasyCare Reusable CuffsMaternal Patient Category Limb Circumference Part NumberAdult (Thigh) 42.0-54.0 cm M1576ALarge Adult 34.0-43.0 cm M1575ALarge Adult XL 34.0-43.0 cm M1575XLAdult 27.0-35.0 cm M1574AAdult XL 27.0-35.0 cm M1574XLSmall Adult 20.5-28.0 cm M1573ASmall Adult XL 20.5-28.0 cm M1573XLCuff kit of 4 adult sizes M1578ACuff kit of 4 adult XL sizes M1579XLMaternal Patient Category Limb Circumference Part NumberAdult (Thigh) 42.0-54.0 cm 989803183371Large Adult 34.0-43.0 cm 989803183361Adult 27.0-35.0 cm 989803183341Adult X-Long 27.0-35.0 cm 989803183351Small Adult 20.5-28.0 cm 989803183331Maternal Patient Category (color) Limb Circumference Part NumberAdult Thigh (gray) 45.0-56.5 cm M4559BAdult Thigh (gray) pack of 5 cuffs 45.0-56.5 cm M4559B5Large Adult X-Long (burgundy) 35.5-46.0 cm M4558BLarge Adult X-Long (burgundy) pack of 5 cuffs 35.5-46.0 cm M4558B5Large Adult (burgundy) 35.5-46.0 cm M4557BLarge Adult (burgundy) pack of 5 cuffs 35.5-46.0 cm M4557B5Adult X-Long (navy blue) 27.5-36.5 cm M4556BAdult X-Long (navy blue) pack of 5 cuffs 27.5-36.5 cm M4556B5Adult (navy blue) 27.5-36.5 cm M4555B
29 Accessories and Supplies279The tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Single Patient Soft CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Single Care CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult Value Care CuffsThe tubing required for all cuffs is M1598B (1.5 m) or M1599B (3.0 m).Adult (navy blue) pack of 5 cuffs 27.5-36.5 cm M4555B5Small Adult (royal blue) 20.5-28.5 cm M4554BSmall Adult (royal blue) pack of 5 cuffs 20.5-28.5 cm M4554B5Cuff kits containing one small adult, one adult, one large adult and one thigh cuff864288Cuff kits containing one small adult, one adult, one adult X-long, one large adult, one large adult X-long and one thigh cuff864291Maternal Patient Category (color) Limb Circumference Part NumberMaternal Patient Category Limb Circumference Part NumberAdult (Thigh) 45.0-56.5 cm M4579BLarge Adult X-Long 35.5-46.0 cm M4578BLarge Adult 35.5-46.0 cm M4577BAdult X-Long 27.5-36.5 cm M4576BAdult 27.5-36.5 cm M4575BSmall Adult 20.5-28.5 cm M4574BMaternal Patient Category Limb Circumference Part NumberLarge Adult 35.0-45.0 cm 989803182321Adult X-Long 27.5-36.0 cm 989803182311Adult 27.5-36.0 cm 989803182301Small Adult 20.5-28.5 cm 989803182291Maternal Patient Category Limb Circumference Part NumberLarge Adult 34.0-43.0 cm 989803160861Adult XL 27.0-35.0 cm 989803160851Adult 27.0-35.0 cm 989803160841Small Adult 20.5-28.0 cm 989803160831
29 Accessories and Supplies280IntelliVue CL NBP Pod AccessoriesSpO2 AccessoriesSome Nellcor sensors contain natural rubber latex which may cause allergic reactions. See the Instructions for Use supplied with the sensors for more information. M1901B, M1903B, and M1904B are not available in USA from Philips. Purchase Nellcor OxiCliq sensors and adapter cables directly from Tyco Healthcare. Some sensors may not be available in all countries.Do not use more than one extension cable with any sensors or adapter cables. Do not use an extension cable with Philips reusable sensors or adapter cables with part numbers ending in -L (indicates "Long" version).All listed sensors operate without risk of exceeding 41°C/105.8°F on the skin if ambient temperature is below 37°C/98.6°F.Make sure that you use only the accessories that are specified for use with this device, otherwise patient injury can result.Description Limb Circumference RangeContents Part NumberMobile CL Reusable Small Adult Cuff21-27 cm 1 cuff 989803163171Mobile CL Reusable Adult Cuff 26.0-34.5 cm 1 cuff 989803163191Mobile CL Reusable Large Adult Cuff33.5-45.0 cm 1 cuff 989803163211Mobile CL Single-Patient Small Adult Cuff21-27 cm 20 cuffs 989803163181Mobile CL Single-Patient Adult Cuff26.0-34.5 cm 20 cuffs 989803163201Mobile CL Single-Patient Large Adult Cuff33.5-45.0 cm 20 cuffs 989803163221Mobile CL NBP Cradle Kit - 20 cradles 989803163251Mobile CL Extension Air Hose, 1.0 m- 1 extension air hose 989803163131Mobile CL NBP Battery Kit - 1 Battery 1 disassembly tool 1 front housing989803163261Telemetry Pouch with window - 50 pouches 989803137831Telemetry Pouch with window - 4 boxes of 50 pouches 989803140371White Telemetry Pouch with Snaps- 50 pouches 989803101971 (9300-0768-050)White Telemetry Pouch with Snaps- 4 boxes of 50 pouches 989803101981 (9300-0768-200)
29 Accessories and Supplies281Philips Reusable SensorsNo adapter cable required.Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.No adapter cable required. SE sensors work with FM30/40/50, as well as with OxiMax-compatible SpO2 versions of other Philips monitors.Philips Disposable SensorsNot available in the USA:Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cableDescription Part NumberAdult sensor (2.0 m cable), for patients over 50 kg. Any finger, except thumb. M1191BM1191A with longer cable (3.0 m) M1191BLSmall adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.M1192AEar sensor (1.5 m cable) for patients more than 40 kg. Use only on adult patients with FM30/40/50.M1194AAdult clip sensor (3 m cable) for patients over 40 kg. Any finger except thumb. M1196AAdult clip sensor (2 m cable) for patients over 40 kg. Any finger except thumb. M1196SDescription Part NumberAdult sensor (0.45 m cable), for patients over 50 kg. Any finger except thumb. M1191TSmall adult, pediatric sensor (0.45 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.M1192TAdult clip sensor (0.9 m cable) for patients over 40 kg. Any finger except thumb. M1196TDescription Part NumberSpecial Edition (SE). Adult sensor (3 m cable), for patients over 50 kg. Any finger except thumb.M1191ANLSpecial Edition (SE). Small adult, pediatric sensor (1.5 m cable) for patients between 15 kg and 50 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.M1192ANSpecial Edition (SE). Ear sensor (1.5 m cable) for patients more than 40 kg. M1194ANDescription Part NumberIdentical to OxiMax MAX-A M1904BIdentical to OxiMax MAX-P M1903BIdentical to OxiMax MAX-N M1901B
29 Accessories and Supplies282Available worldwide:Requires M1943A (1.0 m) or M1943AL (3.0 m) adapter cableNellcor SensorsNellcor sensors must be ordered from Nellcor/Covidien.OxiMax SensorsRequire M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.Oxisensor II SensorsRequires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable.OxiCliq SensorsRequires M1943A (1.0 m) or M1943AL (3.0 m) adapter cable together with OC-3 adapter cable.Description Part NumberAdult/Pediatric finger sensor (0.45 m cable). Use only on adult patients with FM30/40/50.M1131AAdult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. Use only on adult patients with FM30/40/50.M1133AAdult/Pediatric finger sensor (0.9 m cable) for patients >40 kg. Any finger except thumb. Adhesive-free, use only on adult patients with FM30/40/50.M1134ADescription Part NumberAdult finger sensor (patient size >30 kg) OxiMax MAX-AOxiMax MAX-A with long cable OxiMax MAX-ALPediatric foot/hand sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/50.OxiMax MAX-PAdult finger or neonatal foot/hand sensor (patient size >40 kg or <3 kg). Use only on adult patients with FM30/40/50.OxiMax MAX-NDescription Part NumberAdult sensor (patient size >30 kg) Oxisensor II D-25Pediatric sensor (patient size 10-50 kg). Use only on adult patients with FM30/40/50. Oxisensor II D-20Neonatal/Adult sensor (patient size <3 kg or >40 kg). Use only on adult patients with FM30/40/50.Oxisensor II N-25Description Part NumberSee OxiMax MAX-A OxiCliq ASee OxiMax MAX-P. Use only on adult patients with FM30/40/50. OxiCliq PSee OxiMax MAX-N. Use only on adult patients with FM30/40/50. OxiCliq N
29 Accessories and Supplies283Masimo LNOP Reusable SensorsFor use with this sensor the adapter cable LNOP MP12 (M1020-61102) is needed.Masimo LNCS Reusable SensorsFor use with this sensor the adapter cable LNC MP10 (989803148221) is needed.Masimo LNOP Disposable Adhesive SensorsAppropriate LNOP/LNCS adapter cable required.Description Product Number Part NumberAdult Finger Sensor (>30 kg) LNOP DC-I 989803140321Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNOP DC-IP 989803140331Multi-Site Sensor (>1 kg). Use only on adult patients with FM30/40/50.LNOP YI n/aEar Sensor (>30 kg). Use only on adult patients with FM30/40/50.LNOP TC-I 989803140341Description Product Number Part NumberAdult Finger Sensor (>30 kg) LNCS DC-I 989803148281Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNCS DC-IP 989803148291Ear Sensor (>30 kg). Use only on adult patients with FM30/40/50.LNCS TC-I 989803148301Description Product Number Part NumberAdult Sensor (>30 kg) LNOP Adt 989803140231Adult Sensor (>30 kg) LNOP Adtx n/aPediatric Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNOP Pdt 989803140261Pediatric Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNOP Pdtx n/aNeonatal (<3 kg) or Adult adhesive Sensor (>40 kg). Use only on adult patients with FM30/40/50.LNOP Neo-L 989803140291
29 Accessories and Supplies284Masimo LNCS Disposable Adhesive SensorsAppropriate LNOP/LNCS adapter cable required.IntelliVue CL SpO2 Pod AccessoriesAll listed sensors operate without risk of exceeding 41°C on the skin, if the initial skin temperature does not exceed 35°C.Ensure that you use only the accessories that are specified for use with this device, otherwise patient injury can result.1 May not be available in all geographiesExtension / Adapter CablesDescription Product Name Part NumberAdult Sensor (>30 kg) LNCS Adtx 989803148231Pediatric Finger Sensor (10-50 kg). Use only on adult patients with FM30/40/50.LNCS Pdtx 989803148241Neonatal Foot Sensor (<3 kg) or Adult Finger Sensor (>40 kg). Use only on adult patients with FM30/40/50.LNCS Neo-L 989803148271Description Contents Part NumberMobile CL 20 single patient SpO2 Sensors and Cradles for use on patients >10 kg20 Single-Patient Mobile CL DSpO2-1A Sensors 20 Single-Patient Wristbands 20 Single-Patient Cradles pre-assembled989803165941Mobile CL 20 single patient SpO2 Sensors for use on patients >10 kg20 Single-Patient Mobile CL DSpO2-1A Sensors989803165921Mobile CL reusable SpO2 sensor and Cradles for use on patients >15 kg1 Reusable Mobile CL RSpO2-1A Sensor 20 Single-Patient Cradles with pre-attached Wristbands9898031659311Mobile CL 20 SpO2 Cradles (single patient) 20 Single-Patient Cradles with pre-attached Wristbands989803165951Mobile CL 50 SpO2 Wristbands (single patient)50 Single-Patient Wristbands 989803165961Mobile CL SpO2 Battery Kit 1 Battery 1 disassembly tool 1 front housing989803168861Description Comments Part NumberExtension cable (2 m) For use with Philips reusable sensors and adapter cablesM1941AAdapter cable (1.1 m cable) Adapter cable for Philips/Nellcor disposable sensorsM1943AAdapter cable (3 m cable) M1943AL
29 Accessories and Supplies285Tympanic Temperature AccessoriesRecorder PaperSupplied in cases of 40 packs. Each pack has 150 numbered pages. Single use. Use the paper specified here.*Bradycardia and tachycardia alarm ranges are shaded.BatteriesAdapter Cable for OxiCliq sensors Available from Nellcor OC-3Masimo MP 12 LNOP MP Series Patient Cable (3.6 m) Adapter Cable for Masimo LNOP sensorsM1020-61100LNC MP10 LNCS MP Series Patient Cable (3.0 m) Adapter Cable for Masimo LNCS sensors989803148221Description Comments Part NumberDescription Part NumberTemperature probe 989803180831Disposable probe cover with CE marking (22 boxes each containing 96 covers) 989803179611Disposable probe cover (22 boxes each containing 96 covers) 989803179381Geography FHR Scale Grid Color Scale Units Highlighted 3 cm Lines?Part NumberUSA/Canada/Asia 30-240 Red/Orange mmHg Yes M1910AEurope 50-210 Green mmHg and kPa No M1911AJapan 50-210 Green mmHg Yes M1913AJapan 50-210 Green*mmHg Yes M1913JDescription Comment Part Number.Smart Battery 10.8 V, 6000 mAh, Lithium IonFor Avalon FM20 or Avalon FM30 with battery option #E25M4605AAvalon CL Cableless Smart transducer Battery Replacement KitConsists of one Philips Lithium Ion Battery (Part No. 453564107871), a tool to open and close the cableless transducer for battery replacement and two replacement O-ring seals.989803184861
29 Accessories and Supplies286
3028730Specifications and Standards ComplianceThe monitors are intended to monitor a mother and her fetus(es), which from an electrical safety point of view, are one person.Environmental SpecificationsThe monitor may not meet the given performance specifications, if stored and used outside the specified temperature and humidity ranges.Avalon CL Base station 866074 with Option K30 and K40Temperature Range Operating 0°C-45°C (32°F-113°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 45°C (113°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Base station 866074 with Option K60Temperature Range Operating 0°C-40°C (32°F-104°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <90% relative humidity @ 45°C (113°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating 0-2000 m (0-6562 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)
30 Specifications and Standards Compliance288NOTEDo not locate the M2738A ECG/IUP Module directly on the patient’s skin when operated at an environmental temperature above 37°C (98.6°F). When operated at an environmental temperature of 40°C (104°F), the transducers can reach a temperature of 41-43°C (106-110°F).Monitor (M2702A/M2703A/M2704A/M2705A); Interface Cable for Avalon CTS (M2731-60001 and M2732-60001)Temperature Range Operating Without battery option: 0°C-45°C (32°F-113°F)With battery option/charging: 0°C-35°C (32°F-95°F)With battery option/fully charged: 0°C-40°C (32°F-104°F)Storage/Transportation -20°C—60°C (-4°F—140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)Temperature Range Operating 0°C-40°C (32°F-104°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Transducers (866075/866076/866077)Temperature Range Operating 0°C-40°C (32°F-104°F)Charging 0°C-35°C (32°F-95°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Fetal and Maternal Pod (866488)Temperature Range Operating 10°C-40°C (50°F-104°F)Charging 10°C-35°C (50°F-95°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)
30 Specifications and Standards Compliance289WARNINGExplosion Hazard: Do not use in the presence of flammable anesthetics, such as a flammable anesthetic mixture with air, oxygen, nitrous oxide, or in oxygen rich environment. Use of the devices in such an environment may present an explosion hazard.Physical SpecificationsFetal MonitorsAltitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-13100 m (-1640-43000 ft)Avalon CL Fetal and Maternal Pod (866488)Avalon CL Wide Range Pod (866487)Temperature Range Operating 0°C-40°C (32°F-104°F)Charging 0°C-35°C (32°F-95°F)Storage/Transportation -20°C-60°C (-4°F-140°F)Humidity Range Operating <95% relative humidity @ 40°C (104°F)Storage/Transportation <90% relative humidity @ 60°C (140°F)Altitude Range Operating -500-3000 m (-1640-9840 ft)Storage/Transportation -500-4600 m (-1640-15092 ft)SpO2 SensorsOperating Temperature Range 0°C-37°C (32°F-98.6°F)Tympanic TemperatureOperating Temperature Range 16ºC-33ºC (60.8ºF-91.4ºF)Monitor Physical Specifications M2702A/M2703A M2704A/M2705APower Supply Voltages 100 VAC-240 VAC ±10%Supply Frequency Range 50 Hz-60 HzPower Consumption (current)0.7-0.4 A (M2702A/M2703A) 1.3-0.7 A (M8023A#E25)1.3-0.7 ADimensions and WeightSize (without options) mm/(in):width x height x depth286 x 134 x 335 mm(11.3 x 5.3 x 13.2 in)425 x 174 x 365 mm(16.6 x 6.9 x 14.4 in)Weight <5.1 kg (11.2 lbs) <8.8 kg (19.5 lbs)Degree of Protection Against Electrical Shock Type CFElectrical Class Class II equipment Class I equipment
30 Specifications and Standards Compliance290Fetal Monitor SoundsAvalon CL Base StationElectrical Power Source External (AC) without battery option #E25Internal (Lithium Ion battery) if with battery option #E25External (AC)Mode of Operation Continuous operationWater Ingress Protection Code IP X1 (provided recorder drawer is shut)Global Speed (DECG and MECG wave on the screen)6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/secStartup Time Time taken from switching on the monitor to seeing the first parameter labels<30 secondsMonitor Physical Specifications M2702A/M2703A M2704A/M2705ASource DescriptionPatient alarms and INOPs See the sections on “Patient Alarms and INOPs” on page 129, “Standard Philips Alarms” on page 120, and “ISO/IEC Standard Audible Alarms” on page 120.Ultrasound Doppler Direct transmission of Doppler echoes to the speaker of the fetal monitor.Pulse from SpO2, MECG, DECG QRS toneSpO2Optional modulation of the QRS tone for changes in the SpO2 level.NST Timer Tone for Timer expired.Status/Prompt tone Configurable volume tone sounded when status or prompt messages are issued by the fetal monitor.Touch feed back tone Anytime the user touches the display a low beep is issued in response.Avalon CL Base StationDimension and Weight Size mm/(in)W x H x D 349 x 74 x 183 mm (13.8 x 2.9 x 7.2 in)Weight 1 kg (2.3 lbs)Electrical Class When the base station is connected to the monitors M2702A/M2703A/M2704A/M2705A it is a Class II equipment.Electrical Power Source External (powered by fetal monitor)Mode of Operation Continuous operationInterface cable connector type Connector color Red for FM20/30 left side or FM40/50 front fetal connector socketBlack for FM40/50 rear telemetry connector socketInterface cable length 1.5 m (4.11 ft)Ingress Protection IP 31
30 Specifications and Standards Compliance291Wired TransducersAvalon CL TransducersExternal Power Supply (Option K60 for the Avalon CL Base Station)Maximum Weight (with cable) 140 g (4.94 oz) (incl. cable, without country-dependent AC adapter)Size (W x H x D) 52.0 x 39.5 x 85.0 mm (2.0 x 1.6 x 3.4 in)Charging cable length 1.6 m (5.2 ft) (incl. power supply)Supply Voltages 100 VAC-240 VACSupply Frequency Range 50 Hz/60 HzPower Consumption (current) 0.4-0.2AElectrical Class Class IIElectrical Power Source AC MainsMode of Operation ContinuousWater Ingress Protection Code IP40Transducers (M2734A/M2734B/M2735A/M2736A/M2738A)Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage onlyWater Ingress Protection CodeM2734A&B/35/36A IP 68 (immersion up to 1 m water depth for 5 hours)M2738A IP 67 (immersion up to 0.5 m water depth for 30 minutes)Dimensions and WeightM2734A&B/35/36A Size (diameter) 83 mm (3.27 in)Weight (without cable) 0.2 kg (0.5 lb)M2738A Maximum size mm/(in): width x height x depth42 x 30 x 123 mm (1.7 x 1.2 x 4.8 in)Cable length 2.5 mWeight 0.2 kg (0.5 lb)Degree of Protection Against Electrical Shock Type CFTransducer Identification Optical Signal Element (Finder LED), not M2738AAvalon CL Transducers (866075/866076/866077)Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only.Water Ingress Protection Code IP 68 (immersion up to 1 m water depth for 5 hours)Dimensions and WeightAvalon CL Toco+ MP Transducer 866075Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)Weight 0.2 kg (0.5 lb)Avalon CL US Transducer 866076 Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)Weight 0.2 kg (0.5 lb)Avalon CL ECG/IUP Transducer 866077Size (diameter/height) 76 mm/37 mm (3 in/1.5 in)Weight 0.2 kg (0.5 lb)
30 Specifications and Standards Compliance292Avalon CL Fetal & Maternal PodAvalon CL Wide Range PodInterface Cable Avalon CTSExternal Power Supply Option E25Degree of Protection Against Electrical Shock Type CFTransducer Identification Optical Signal Element (Finder LED)Avalon CL Transducers (866075/866076/866077)Avalon CL Fetal & Maternal Pod (866488)Shock Resistance Withstands a 1.5 m drop to concrete surface with possible cosmetic damage only.Water Ingress Protection Code IP 67 (immersion up to 1 m water depth for 30 minutes)Dimensions and Weight W x H x D 63 x 20 x 49 mm (2.5 x 0.8 x 1.9 in)Weight 0.07 kg (0.15 lb)Degree of Protection Against Electrical Shock Type CFPod Identification Optical Signal Element (Finder LED)Avalon CL Wide Range Pod (866487)Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage only.Water Ingress Protection Code IP 32 (protection from dripping water)Dimensions and Weight W x H x D 55 x 26.5 x 122 mm (2.1 x 1 x 4.8 in)Weight 0.14 kg (0.3 lb)Interface Cable for Avalon CTS (M2731-60001 and M2732-60001)Shock Resistance Withstands a 1 m drop to concrete surface with possible cosmetic damage onlyWater Ingress Protection Code IP X1Dimensions and Weight Maximum size mm/(in): width x height x depth55 x 28 x 50 mm (2.2 x 1.1 x 2.0 in)Cable length 2.5 mWeight 0.2 kg (0.5 lb)M8023A (Option #E25) External Power Supply Weight and DimensionsMaximum Weight 0.6 kg (1.4 lb)Size (W x H x D) 208 x 105 x 89 mm (8.2 x 4.1 x 5.3 in)
30 Specifications and Standards Compliance293Interface SpecificationsFetal Monitors1 The power loss indication functionality of the Nurse Call Relay board is not supported with fetal monitors.Interface SpecificationsNetwork Standard 100-Base-TX (IEEE 802.3 Clause 25)Connector RJ45 (8 pin)Isolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)MIB/RS232 Standard IEEE 1073-3.2-2000Connectors RJ45 (8 pin)Mode Software-controllable BCC (RxD/TxD cross over) or DCC (RxD/TxD straight through)Power 5 V ±5%, 100 mA (max.)Isolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)USB Interface Standard USB 2.0 full-speed (embedded host)Connectors USB series "Standard A" receptaclePower Low power port 4.4V min; max. load for all ports together 500 mAIsolation noneRS232 (Standard) Connectors RJ45 (8 pin)Power noneIsolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)RS232 (Independent display interface option)Connectors RJ45 (8 pin)Power noneIsolation noneFlexible Nurse Call Relay1Connectors 20 pin MDR (Mini D-Ribbon), active open and closed contactsContact 100 mA, 24 V DCIsolation Basic isolation (reference voltage: 250 V; test voltage: 1500 V)Delay <[Configured Latency +0.5] sec
30 Specifications and Standards Compliance294Avalon CL Radio*Wireless transmissions are encrypted for security.CL Wide Range Pod RadioAvalon CL Radio Interface SpecificationsElectronic Article Surveillance (EAS) EAS tag inside the housing (58 kHz)Short Range Radio Interface* Type Internal SRR interfaceTechnology IEEE 802.15.4Frequency Band 2.4 GHz ISM (2.400-2.483 GHz)Modulation Technique DSSS (O-QPSK)Effective radiated power max. 0 dBm (1 mW)Range ca. 5 m without any physical obstructions as walls and doorsOBR (WMTS)* Frequency Band 608-614 MHzEffective radiated power <10 mW (base station) <1 mW (CL transducers)Range min. 100 m/300 ft (in line of sight)OBR (ISM)* Frequency Band 433.05-434.79 MHzEffective radiated power <10 mW (base station) <1 mW (CL transducers)Range min. 100 m/300 ft (in line of sight)OBR (T108)* Frequency Band 920.6-923.4 MHzEffective radiated power <40 mW (base station) <10 mW (CL transducers)Range min. 100 m/300 ft (in line of sight)OBR (OB Radio)OBR (WMTS) Frequency Band 608-614 MHzEffective radiated power <1 mWRange 5 m/16 ftOBR (ISM) Frequency Band 433.05-434.79 MHzEffective radiated power <1 mWRange 5 m/16 ftOBR (T108) Frequency Band 920.6-923.4 MHzEffective radiated power <5 mWRange 5 m/16 ftShort Range Radio SpecificationsType Built-in interface with integrated antennaTechnology IEEE 802.15.4
30 Specifications and Standards Compliance295Performance SpecificationsEssential PerformanceThis section defines the essential performance for Avalon fetal monitors in combination with the specified wired transducers and sensors, and also with the cableless measurements (Avalon CL, Avalon CTS).Under normal and single fault conditions either at least the performance/functionality listed in the tables below is provided, or failure to provide this performance/functionality is readily identifiable by the user (e.g. technical alarm, no waves and/or numeric values, complete failure of the monitor, readily identifiable distorted signals, etc.).Frequency Band 2.4 GHz ISM (2400-2483 GHz) MBAN (2360-2400 GHz, for US / FCC regulated countries only)1Modulation DSSS (O-QPSK)Bandwidth 5 MHzEffective Radiated Power (ERP) max. 0 dBm (1 mW)Short Range Radio SpecificationsWLAN SpecificationsType Internal wireless adapterTechnology IEEE 802.11a/b/g/nFrequency Band USA: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.725-5.825 GHzEurope: 2.400-2.483 GHz, 5.15-5.35 GHz, 5.47-5.725 GHzJapan: 2.400-2.483 GHz, 5.150-5.250 GHz, 5.25-5.35 GHz, 5.470-5.725 GHzChina: 2.400-2.483 GHz, 5.725-5.85 GHzModulation Technique 802.11b/gDSSS (DBPSK, DQPSK, CCK)OFDM (BPSK, QPSK, 16-QAM, 64-QAM)802.11aOFDM (BPSK, QPSK, 16-QAM, 64-QAM)Effective Radiated Power (ERP) 2.400-2.483 GHz: max. 18 dBm (63 mW)5.150-5.725 GHz: max. 19 dBm (79 mW)5.745-5.825 GHz: max. 14 dBm (25 mW)Measurement Essential PerformanceGeneral No interruption or cessation of current operating mode (e.g. no reboot, display OK).No spontaneous operation of controls (e.g. no activation of touchscreen without user interaction).
30 Specifications and Standards Compliance296The table above also represents the minimum performance when operating under non-transient electromagnetic phenomena according to IEC 60601-1-2:• Radiated electromagnetic fields• Conducted disturbances induced by RF fields• Conducted disturbances induced by magnetic fields• Voltage dips/voltage variationsThe following table identifies minimum performance for transient electromagnetic phenomena according to IEC 60601-1-2:• Electrostatic Discharge (ESD)• Electrical Fast Transients/Bursts•Surges• Voltage interruptionsECG (Monitoring) Measurement of the fetal and maternal heart rate over the specified measurement range and with an accuracy of ± 5 bpm.Alarming on heart rate limit violation within specified delay time.Maternal Pulse from Toco (MP) Measurement of the maternal pulse rate within the specified limits.MP is susceptible to movement artifact potentially resulting in signal loss. It is not intended for continuous maternal HR monitoring. Limit alarms are not provided.NBP Measurement of noninvasive systolic, diastolic, and mean blood pressure and pulse rate within specified accuracy and error limits.Automatic cyclingAlarming on limit violations of systolic, diastolic, and mean blood pressure, and pulse rate.SpO2Measurement of oxygen saturation and pulse rate within the specified accuracy/error limits.Alarming on oxygen saturation and pulse rate limit violation.Temperature (tympanic) Measurement of temperature within specified accuracy/error limits.Alarming on temperature limit violation.Toco extern Measurement of the external Toco ± 5 units on display and recorder (with paper adjusted).Toco intern (IUP) Measurement of the internal Toco within specified accuracy limits on display and recorder (with paper adjusted).Ultrasound Measurement of the fetal heart rate ± 5 bpm on display and recorder (with paper adjusted).Ultrasound energy within safe limits for continuous operation: p_ < 1 MPa, Iob < 20 mW/cm2, Ispta < 100 mW/cm2.Measurement Essential Performance
30 Specifications and Standards Compliance297Fetal MonitorsBattery SpecificationsMeasurement Essential PerformanceAll After electrostatic discharge, fast transients/bursts, surges and electro surgery interference, the equipment will return to previous operation mode within 10 seconds (SpO2 30 seconds) without loss of any stored data.After voltage interruptions the equipment returns to previous state without operator intervention and loss of data.Fetal Monitor Performance SpecificationsAlarm Signal System alarm delay. The system alarm delay is the processing time the system needs for any alarm to be indicated on the fetal monitor, after the measurement has triggered the alarm.less than 4 secondsPause duration 1, 2, 3 minutes or infinite, depending on the configurationExtended alarm pause 5 to 10 minutesSound pressure range min. 0 dB(A) max. 45-85 dB(A)Review Alarms Information all alarms/INOPs, main alarms on/off, alarm silence and time of occurrenceCapacity 300 itemsReal time Clock Range from: January 1, 1997, 00:00 to: December 31, 2080, 23:59Accuracy better than ±1 min. per monthHold Time infinite if powered by AC; otherwise at least 48 hoursBuffered Memory Hold Time if powered by AC infinite without power: at least 8 hoursContents active settings, review alarms, stored trace dataPerformance SpecificationsAvalon FM20/30 Battery Option #E25Operating Time (with new, fully charged battery)Basic monitoring configuration: >2 hours(Display Brightness: 70%, Recorder: "On" at 3 cm/min, NBP: Auto Mode at 15 min, 2 US Transducers, 1 Toco+ with MECG, 1 Patient Module with DECG)Charge Time When monitor is off: approx. 6 hours When monitor is in use: more than 10 hours (depending on monitor configuration)
30 Specifications and Standards Compliance298Fetal / Maternal SpecificationsUltrasoundComplies with IEC 60601-2-37:2007 / EN 60601-2-37:2008Performance SpecificationAvalon CL Transducer BatteryOperating time With a new and fully charged battery min. 10 hoursCharge time From a "low battery" indication to a "fully charged" indication <3 hoursCharge time with Avalon FM20/30 Battery Option #E25From a "low battery" indication to a "fully charged" indication >6 hours.Performance SpecificationAvalon CL F&M Battery Operating time With a new and fully charged battery min. 16 hoursCharge time From a "low battery" indication to a "fully charged" indication <3 hoursCharge time with Avalon FM20/30 Battery Option #E25From a "low battery" indication to a "fully charged" indication >6 hours.Performance SpecificationAvalon CL Wide Range Pod BatteryOperating time With a new and fully charged battery min. 4 hoursCharge time From a "low battery" indication to a "fully charged" indication <3 hoursPerformance SpecificationsUltrasoundMeasurement Method Ultrasound Pulse DopplerMeasurement Range US 50-240 bpmResolution Display 1 bpmPrinter 1/4 bpmJitter @ 200 bpm 3 bpmDisplay Update Rate 1 per second
30 Specifications and Standards Compliance299TocoUS Intensity (M2736A/AA) Average output power P = (7.4 ± 0.4) mWPeak-negative acoustic pressure p_ = (40.4 ± 4.3) kPaOutput beam intensity (Iob)(= spatial average - temporal average intensity)Isata = (2.38 ± 0.59) mW/cm2Spatial-peak temporal average intensity Ispta = (15.0 ± 3.2) mW/cm2Effective radiating area @ -12 dB (3.11 ± 0.74) cm2Thermal index (TI) and mechanical index (MI) are always below 1.0.US Intensity CL (866076) Average output power P = (12.4 ± 0.4) mWPeak-negative acoustic pressure p_ = (49.1 ± 5.2) kPaOutput beam intensity (Iob)(= spatial average - temporal average intensity)Isata = (2.77 ± 0.56) mW/cm2Spatial-peak temporal average intensity Ispta = (21.1 ± 5.1) mW/cm2Effective radiating area @ -12 dB A-12dB = (4.47 ± 0.89) cm2Thermal index (TI) and mechanical index (MI) are always below 1.0.Signal Quality Indication Poor Quality emptyAcceptable Quality half-fullGood Quality fullBeat-to-Beat change (max.) for Ultrasound 28 bpmUS Frequency 1 MHz ± 100 HzUS Signal range 3.5 μVpp-350 μVpp @ 200 HzUS Burst Repetition Rate 3.0 kHzDuration 100 μsFMP Signal Range @ 33 Hz 200 μVpp-40 mVppPerformance SpecificationsPerformance SpecificationsTocoMeasurement Method Strain Gauge Sensor ElementSensitivity 1 unit = 2.5 gResolution Display 1 unitPrinter 1/4 unitMeasurement Range 400 unitsSignal Range 0-127 unitsMaximum Offset Range -300 unitsBaseline Setting 20 units
30 Specifications and Standards Compliance300IUPECGComplies with IEC 60601-2-27:2011 / EN 60601-2-27:2014 except clauses listed below:• 201.6.2, 201.8.5.5• 201.12.1.101• 202.6.2.101Update Rate Display 1 per secondPrinter ~4 per secondAuto Offset Correction 3 seconds after connecting the transducer, the Toco value is set to 20 unitsAuto Zero Adjust Toco value is set to zero following a negative measurement value for 5 secondsPerformance SpecificationsPerformance SpecificationsMaternal Pulse from TocoEmitted Light Energy 15 mWWavelength Range 780-1100 nmRange 40-240 bpmResolution 1 bpmDisplay Update Rate 1 per secondAccuracy ± 2% or 1 bpm, whichever is greaterUpdate Rate every 4 secondsPerformance SpecificationsIUPMeasurement Method Passive Resistive Strain Gauge ElementsMeasurement Range -100-+300 mmHgSignal Range -99-127 mmHg or (-13.2-16.9 kPa)Resolution Display 1 mmHgPrinter 1/4 mmHgSensitivity 5 μV/V/mmHgOffset Compensation +100- -200 mmHgAccuracy (not including sensor accuracy) ±0.5% per 100 mmHgUpdate Rate Display 1 per secondPrinter ~4 per secondAuto Offset Correction 3 seconds after connecting the transducer, the IUP value is set to 0 mmHg
30 Specifications and Standards Compliance301WARNINGThe fetal/maternal monitor is not a diagnostic ECG device. In particular, the display of fetal/maternal ECG is intended only for evaluating signal quality for fetal/maternal heart rate as derived from the ECG waveform.When in doubt, it can be used to identify sources of compromised signal quality, such as noise or muscle artifacts. It can subsequently be used to verify the result of measures taken to resolve them (e.g., checking ECG cable connections or adapting the fetal ArtifactSuppress configuration).The safety and effectiveness of the displayed fetal/maternal ECG waveform (i.e., P, QRS, and T segments) for evaluation of fetal/maternal cardiac status during labor have not been evaluated.Performance SpecificationsECGPerformance Specifications Type DECG Single Lead ECG (derived from Fetal Scalp Electrode)MECG Single Lead ECG (derived from RA and LA electrodes)Measurement Range 30-240 bpmResolution Display 1 bpm (display update rate 1 per second)Recorder 1/4 bpmWave Speed (Global Speed) 6.25 mm/sec, 12.5 mm/sec, 25 mm/sec, 50 mm/secAccuracy ±1 bpm or 1%, whichever is greater (non-averaging)Beat-to-Beat change (max.) MECG: 28 bpmDECG: 28 bpm (with Artifact Suppression On)Differential Input Impedance >15MΩElectrode Offset Potential Tolerance ±400 mVINOP Auxiliary Current (Leads Off Detection) <100 μAInput Signal Range DECG 20 μVpp-6 mVppMECG 150 μVpp-6 mVppDielectric Strength 1500 VrmsDefibrillator Protection NoneESU Protection NonePaced pulse detection None
30 Specifications and Standards Compliance302Fetal Heart Rate (Ultrasound/DECG) Alarm Specifications FHR Alarm Limits Range Bradycardia (low limit) 60-200 bpm adjustable in 10 bpm stepsDefault: 110 bpmTachycardia (high limit) 70-210 bpm adjustable in 10 bpm stepsDefault: 170 bpmFHR Alarm Delay Range Bradycardia (low limit) Delay 10-300 seconds in steps of 10 seconds + system alarm delayDefault: 240 secondsTachycardia (high limit) Delay 10-300 seconds in steps of 10 seconds + system alarm delayDefault: 300 secondsSignal Loss Delay 10-30 seconds in steps of 10 seconds + system alarm delayMECG Alarm SpecificationsRange Adjustment Alarm DelayMECG Alarm Limits High Range: 31-240 bpmDefault: 120 bpm1 bpm steps (30-40 bpm) 5 bpm steps (40-240 bpm)System alarm delay (see “Fetal Monitors” on page 297).Low Range: 30-235 bpmDefault: 50 bpmExtreme Tachycardia Difference to high limit: 0-50 bpmDefault: 20 bpm5 bpm stepsClamping at: 150-240 bpmDefault: 200 bpm5 bpm stepsExtreme Bradycardia Difference to low limit: 0-50 bpmDefault: 20 bpm5 bpm stepsClamping at: 30-100 bpmDefault: 40 bpm5 bpm stepsMaternal ECG Supplemental Information as required by IEC 60601-2-27Heart Rate Averaging Method The maternal heart rate is computed by averaging the 12 most recent R-R intervals. If each of three consecutive R-R intervals is greater than 1200 ms (i.e. rate less than 50 bpm), then the four most recent R-R intervals are averaged to compute the HR.Display Update Rate 2 secondsVentricular tachycardia alarm for waveforms B1 and B2No heart rate is detected for waveforms B1 and B2, resulting in *** Extreme Brady alarm
30 Specifications and Standards Compliance303aFHR, aHR, aTocoResponse Time of Heart Rate Meter to Change in Heart RateHR change from 80-120 bpm: 10 seconds HR change from 80-40 bpm: 14 secondsTall T-Wave Rejection Capability M2735A 1.2 mV T-Wave amplitudeM2738A 1.4 mV T-Wave amplitudeCL Toco+ MP, CL ECG/IUP1.2 mV T-Wave amplitudeResponse Time of Heart Rate meter to Change in Heart RateM2735A, M2738A HR change from 80-120 bpm Average: 12 secondsHR change from 80-40 bpm Average: 15 secondsCL Toco+ MP, CL ECG/IUPHR change from 80-120 bpm Average: 10 secondsHR change from 80-40 bpm Average: 12 secondsHeart Rate Meter Accuracy and Response to Irregular RhythmM2735A, M2738A Ventricular bigeminy 40-60 bpmSlow alternating ventricular bigeminy 45 bpmRapid alternating ventricular bigeminy 163 bpmBidirectional systoles 63-73 bpmCL Toco+ MP, CL ECG/IUPVentricular bigeminy 40-60 bpmSlow alternating ventricular bigeminy 30 bpmRapid alternating ventricular bigeminy 70-163 bpmBidirectional systoles 63-73 bpmMaternal ECG Supplemental Information as required by IEC 60601-2-27aFHRMeasurement Method electrocardiographyMeasurement Range 60-240 bpmResolution Display 1 bpmPrinter 1/4 bpmAccuracy ±1 bpmaHRMeasurement Method electrocardiographyMeasurement Range 40-240 bpmResolution Display 1 bpmPrinter 1/4 bpmAccuracy ±1 bpmaTocoMeasurement Method uterine electromyographyMeasurement Range 0-500 μV
30 Specifications and Standards Compliance304Noninvasive Blood PressureComplies with IEC 80601-2-30:2009 / EN 80601-2-30:2010.*1: Clinical investigation with the auscultatory reference method• The 5th Korotkoff sound (K5) was used to determine the diastolic reference pressures.• The approximation MAP = (2*DIA + SYS) / 3 was used to calculate reference MAP (mean arterial pressure) values from the systolic and diastolic reference pressures.Resolution 0-255 levels representing 100% of the full scaleAccuracy ±5%aTocoPerformance Specifications Measurement RangesSystolic 30-270 mmHg (4-36 kPa)Diastolic 10-245 mmHg (1.5-32 kPa)Mean 20-255 mmHg (2.5-34 kPa)Accuracy1Max. Std. Deviation: 8 mmHg (1.1 kPa) Max. Mean Error: ±5 mmHg (±0.7 kPa)Pulse Rate Range 40-300 bpmAccuracy (average over noninvasive blood pressure measurement cycle)40-100 bpm: ±5 bpm101-200 bpm: ±5% of reading201-300 bpm: ±10% of readingMeasurement Time Typical at HR >60 bpmAuto/manual: 30 seconds (adult)Maximum time: 180 seconds (adult)Cuff Inflation Time Typical for normal adult cuff: Less than 10 secondsInitial Cuff Inflation Pressure 165 ±15 mmHgAuto Mode Repetition Times 1, 2, 2.5, 3, 5, 10, 15, 20, 30, 45, 60, or 120 minutesVenipuncture Mode InflationInflation Pressure 20-120 mmHg (3-16 kPa)Automatic deflation after 170 secondsAlarm Specifications Range Adjustment Alarm DelaySystolic Adult: 30-270 mmHg (4-36 kPa)10-30 mmHg: 2 mmHg (0.5 kPa) >30 mmHg: 5 mmHg (1 kPa)System alarm delay (see “Fetal Monitors” on page 297).Diastolic Adult: 10-245 mmHg (1.5-32 kPa)Mean Adult: 20-255 mmHg (2.5-34 kPa)
30 Specifications and Standards Compliance305SpO2Complies with ISO 80601-2-61:2011 / EN 80601-2-61:2011.Measurement Validation: The SpO2 accuracy has been validated in human studies against arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements.Display Update Period: Typical: 2 seconds, maximum: 30 seconds. Maximum with noninvasive blood pressure INOP suppression on: 60 seconds.Overpressure Settings Adjustment> 300 mmHg (40 kPa) > 2 sec not user adjustableSpO2 Performance Specifications SpO2The specified accuracy is the root-mean-square (RMS) difference between the measured values and the reference valuesRange 0-100%Accuracy Philips Reusable Sensors: M1191A/B, M1191AL/BL, M1191ANL, M1192A, M1192AN = 2% (70%-100%)M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3% (70%-100%)Philips Disposable Sensors with M1943A(L): M1131A, M1901B, M1903B, M1904B = 3% (70%-100%)M1133A, M1134A = ±2% (70%-100%)Nellcor® Sensors with M1943A(L): MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A, P, N = 3% (70%-100%)Masimo Reusable Sensors® with LNOP MP12 or LNC MP10:LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP: 2% (70%-100%)LNOP TC-I, LNCS TC-I: 3.5% (70%-100%)Masimo Disposable Sensors® with LNOP MP12 or LNC MP10:LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx, LNCS Pdtx: 2% (70%-100%)LNOP Neo-L, LNCS Neo-L: 3% (70%-100%)Resolution 1%Pulse Range 30-300 bpmAccuracy ±2% or 1 bpm, whichever is greaterResolution 1 bpm
30 Specifications and Standards Compliance306Tympanic TemperatureComplies with:• EN 12470-5 (Clinical thermometers - Part 5:2003: Performance of infra-red thermometers)• ASTM E1965-98 (Infrared Thermometers for Intermittent Determination of Patient Temperature)with minor exceptions as noted below.The fetal monitor additionally complies with ISO 80601-2-56:2009 / EN ISO 80601-2-56:2012.Sensors Wavelength range 500-1000 nm. Information about the wavelength range can be especially useful to clinicians (for instance, when photodynamic therapy is performed).Emitted Light Energy15mWPulse Oximeter Calibration Range 70%-100%SpO2 Performance Specifications SpO2 Alarm Specifications Range Adjustment DelaySpO250-100% 1% steps (0, 1, 2, 3,... 30) + 4 secondsDesat 50-Low alarm limit 1% stepsPulse 30-300 bpm 1 bpm steps (30-40 bpm) 5 bpm steps (40-300 bpm)max. 14 secondsTachycardia Difference to high limit 0-50 bpm 5 bpm steps max. 14 secondsClamping at 150-300 bpm 5 bpm stepsBradycardia Difference to low limit 0-50 bpm 5 bpm steps max. 14 secondsClamping at 30-100 bpm 5 bpm stepsPerformance SpecificationsTemperature Resolution 0.1°C or 0.1°FResponse Time less than 2 secondsTemperature Calibrated Accuracy Specifications (out of the Factory)Ambient Temperature Target Temperature Accuracy25.0°C (77.0°F) 37.7°C-38.9°C (98.4°F-102.0°F) ±0.1°C (±0.2°F)16.0°C-33.0°C (60.8°F-91.4°F) 33.0°C-42.0°C (91.4°F-107.6°F) ±0.2°C (±0.4°F)Temperature Calibrated Accuracy Specifications (after recalibration using Genius 2 Checker/Calibrator)Ambient Temperature Target Temperature Accuracy16.0°C-33.0°C (60.8°F-91.4°F) 36.0°C-39.0°C (96.8°F-102.2°F) ±0.2°C (±0.4°F)
30 Specifications and Standards Compliance30716.0°C-33.0°C (60.8°F-91.4°F) <36.0°C or >39.0°C (<96.8°F or >102.2°F)±0.3°C (±0.5°F)ASTM laboratory requirement for IR thermometers in the display range 37.0°C-39.0°C (98.0°F-102.0°F) is ±0.2°C (±0.4°F), whereas for mercury-in-glass and electronic thermometers, the requirement per ASTM standards E667-86 and E1112-86 is ±0.1°C (±0.2°F).Clinical accuracy characteristics and procedures are available from Covidien llc on request. To verify the accuracy, use a certified black body as specified in EN ISO 80601-2-56, Annex C, or use a Genius 2 Checker/Calibrator - available from Covidien llc under part number 303097.Clinical repeatability: meets section A.5 of EN ISO 80601-2-56(E) per Covidien llc technical report. Data is available from Covidien llc on request.Performance SpecificationsDisplayed Temperature Measurement RangeMode Range °C Range °FEar 33.0-42.0°C 91.4-107.6°FOral (ear + 0.6°C) 33.6-42.0°C 92.5-107.6°FCore (ear + 1.04°C) 34.0-42.0°C 93.2-107.6°FRectal (ear + 1.16°C) 34.2-42.0°C 93.6-107.6°FCaution: ASTM E1965-98 specifies 34.4°C-42.2°C (94°F-108°F)Ambient Temperature RangeMode Range °C Range °FOperating 10%-95% RH, non-condensing16.0-33.0°C 60.8-91.4°FStorage up to 95% RH, non-condensing-25.0-55.0°C -13.0-131.0°FCaution: EN ISO 80601-2-56 specifies 16.0°C-35.0°C (60.8°F-95.0°F), 10%-95% RH, non-condensing ASTM E1965-98 specifies 16.0°C-40.0°C (60.8°F-104.0°F), up to 95% RH, non-condensingStoring the thermometer outside the specified temperature/humidity range might adversely affect measurement accuracy. Check the calibration after storage in uncertain conditions.Tympanic Temperature Alarm SpecificationsRange 33.0°C-42.0°C (91.0°F-108.0°F)Adjustment 0.5°C steps (33.0°C-35.0°C)0.1°C steps (35.0°C-42.0°C)1.0°F steps (91.0°F-95.0°F)0.2°F steps (95.0°F-108.0°F)Alarm delay System alarm delay (see “Fetal Monitors” on page 297).
30 Specifications and Standards Compliance308Physical SpecificationsRecorder SpecificationsThermometerDimensions 190 mm x 43 mm x 55 mm (±3 mm)Cable length 60 ±5 cm (spiral cable relaxed)250 ±15 cm (spiral cable extended)Weight (including cable) 180 ±10 gIngress protection classification IP 21Base StationDimensions 205 mm x 65 mm x 75 mm (±3 mm)Weight (excluding cable) 400 g ±10 gBuilt-in Thermal Array Fetal Trace RecorderMechanism Thermal Array RecorderPaper & Printing Type Standard Z-fold paperStandard Speeds (real-time traces) 3 cm/min, 2 cm/min, 1 cm/minFast Print Speed (stored traces) Max. 20 mm/s Print speed is variable and depends on the print loadECG Wave Print Speed (not real-time)Emulated 25 mm/s Print speed is variable and depends on the print loadPaper Advance 20 mm/sSensing Optical Reflex Sensor for black page marksAccuracy @ 3 cm/min, 2 cm/min, 1 cm/min±5 mm/pageUsable Print Width 128 mmResolution 8 dots/mm (200 dpi)Time Delay to see trace on paper <30s @ 1 cm/minTrace Separation Offset for FHR (Ultrasound and DECG)Twin Standard FHR2 +20 bpmClassic FHR1 +20 bpm FHR2 Triplet Standard FHR2 +20 bpm FHR3 -20 bpmClassic FHR1 +20 bpm FHR3 -20 bpm and/or FHR3
30 Specifications and Standards Compliance309Recorder SymbolsSymbol DescriptionParameter is capable of alarming and alarms were enabled at the time of printing the annotation. The low limit is printed before the symbol, and the high limit after it.Parameter is capable of alarming, but alarms were disabled at the time of printing the annotation. (Note: There is no alarm related annotation at all if a parameter does not have alarming capability.)FMP detection is onBeginning of the date/time annotationWarning (INOP)Measurement from a cableless transducer (printed next to measurement label)Measurement from a cableless measurement PodsMeasurement from cableless devices connected with WLAN (CL Wide Range Pod)Pulse from SpO2Pulse from Toco MPPulse from NBPTrace separation +20 bpm (in label)Trace separation -20 bpm (in label)Trace separation Off (in trace)Trace separation +20 bpm (in trace)
30 Specifications and Standards Compliance310External Displays: FM40/FM50 OnlyExternal displays can be connected with a maximum cable run of 10 m. External displays must be approved for medical use (IEC 60601-1). The video output of the Avalon FM40/FM50 has VGA resolution.Manufacturer's InformationYou can write to Philips at this address:Philips Medizin Systeme Boeblingen GmbHHewlett-Packard-Str. 271034 BoeblingenGermanyVisit our website for local contact information at: www.healthcare.philips.com© Copyright 2016. Koninklijke Philips N.V. All Rights Reserved.Trademark AcknowledgmentOxisensorTM II, Oxi-CliqTM, and OxiMaxTM are trademarks of Tyco Healthcare Group LP, Nellcor Puritan Bennett Division.Trace separation -20 bpm (in trace)Trace separation +20 bpm and -20 bpm (in trace)Coincidence of heart rates is detectedMarkerSpecial wave, with different speed and scale (for example, fast printout of MECG wave on FM30)Recorder SymbolsSymbol Description
30 Specifications and Standards Compliance311Regulatory and Standards ComplianceThe fetal monitors are in conformity with the requirements of the European Medical Devices Directive 93/42/EEC and bear the CE marking:The fetal monitors are classified into Class IIb according to Annex IX rule 10.The Avalon CL Transducer System is in conformity with the requirements of the European Radio Equipment and Telecommunications Terminal Equipment Directive 99/5/EC. The Avalon CL base station used in this system is class 1 and the Avalon CL transducers of this system are class 1 under the scope of the R&TTE Directive.To obtain a copy of the original Declaration of Conformity, please contact Philips at the address given in the “Manufacturer's Information” on page 310 section of this manual.Safety and PerformanceThe fetal monitors comply with the following major international safety and performance standards:• IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013• IEC 60601-1-6:2010 / EN 60601-1-6:2013• IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+AC:2013• IEC 60601-2-49:2011 / EN 60601-2-49:2015• ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010• CAN/CSA C22.2#60601-1-08• JIS T 1303 2005• AS/NZS 3200.1.0-1998The possibility of hazards arising from hardware and software errors was minimized in compliance with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013.Alarm sounds are compliant with Standard IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+A1:2013+AC:2014.CompatibilityWhen your fetal monitor is compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and related standards, it can still be used with the Avalon CL Transducer System and the software upgrade J.3 or higher, and all measurement accessories that are compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013 (Edition 3) and related standards.When your fetal monitor is compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013 (Edition 3) and related standards, it can still be used with the Avalon CTS Transducer System, and all measurement accessories that are compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and related standards.
30 Specifications and Standards Compliance312RadioThe Avalon CL Transducer System complies with the following major international radio standards:• ETSI EN 300 220-1:2012• ETSI EN 300 220-2:2012• ETSI EN 301 489-1:2011• ETSI EN 301 489-3:2013• FCC 47 CFR Part 95• IC RSS-210 Issue 8• ARIB STD-T108• ETSI EN 300 328:2012• ETSI EN 301 489-17:2012• FCC 47 CFR Part 2 & 15• AS/NSZ 4268•ARIB STD-T66Safety Tests Fetal MonitorAll the safety tests and procedures required after an installation, or an exchange of system components are described in your monitor's Service Guide. These safety tests are derived from international standards, but may not be sufficient to meet local requirements.WARNING• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple portable socket-outlet is used, the resulting system must be compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013• Do not connect any devices that are not supported as part of a system.• Do not use a device in the patient vicinity if it does not comply with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013. The whole installation, including devices outside of the patient vicinity, must comply with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013. Any non-medical device, including a PC running an OB TraceVue/IntelliSpace Perinatal system, placed and operated in the patient's vicinity must be powered via a separating transformer (compliant with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2013) that ensures mechanical fixing of the power cords and covering of any unused power outlets.• Do not use USB devices with own power supplies, unless an appropriate separation device is used, (either between USB interface and device or between device and power).During the installation the fetal monitor is configured for your environment. This configuration defines your custom default settings you work with when you switch on your fetal monitor. See the fetal monitor's Service Guide and the Configuration Guide for details on how to configure your fetal monitor.
30 Specifications and Standards Compliance313Electromagnetic Compatibility (EMC)The device and its accessories, listed in the accessories section, comply with the following EMC standards:• IEC 60601-1-2:2007 / EN 60601-1-2:2007+AC:2010Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment. You must operate your monitoring equipment according to the EMC information provided in this book. Before using the device, assess the electromagnetic compatibility of the device with surrounding equipment.This ISM device complies with Canadian ICES-003:2012. Cet appareil ISM est conforme à la norme NMB-003 du Canada.CAUTION•FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth conductor which is needed for EMC purposes.• Always use the supplied power cord with the three-prong plug to connect the monitor to AC mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet.WARNINGThe use of accessories, transducers, and cables other than those specified, may result in increased electromagnetic emissions, or decreased electromagnetic immunity of the device.WARNINGDo not use cordless/mobile phones, or any other portable RF communication system within the patient vicinity, or within a 1.0 m radius of any part of the fetal monitoring system.WARNINGFor paced patients: The radiated SRR power of the CL SpO2 and CL NBP Maternal Cableless Measurement Devices, and other sources of radio-frequency energy, when used in very close proximity of a pacemaker, might be sufficient to interfere with pacemaker performance. Due to shielding effects of the body, internal pacemakers are somewhat less vulnerable than external pacemakers. However, caution should be exercised when monitoring paced patients.In order to minimize the possibility of interference, avoid positioning and wearing the Cableless Measurement Devices in very close proximity to a pacemaker. Consult the pacemaker manufacturer for information on the RF susceptibility of their products.
30 Specifications and Standards Compliance314EMC TestingCAUTIONFetal parameters, especially ultrasound and ECG, are sensitive measurements involving small signals, and the monitoring equipment contains very sensitive high gain front-end amplifiers. Immunity levels for radiated RF electromagnetic fields and conducted disturbances induced by RF fields are subject to technological limitations. To ensure that external electromagnetic fields do not cause erroneous measurements, it is recommended to avoid the use of electrically radiating equipment in close proximity to these measurements.Reducing Electromagnetic InterferenceWARNINGThe device should not be used adjacent to, or stacked with, other equipment unless otherwise specified.The product and associated accessories can be susceptible to interference from continuous, repetitive, power line bursts, and other RF energy sources, even if the other equipment is compliant with EN 60601-1-2 emission requirements. Examples of other sources of RF interference are other medical electrical devices, cellular products, information technology equipment, and radio/television transmissions.When electromagnetic interference (EMI) is encountered, for example, if you can hear spurious noises on the fetal monitor's loudspeaker, attempt to locate the source. Assess the following:• Is the interference due to misplaced or poorly applied transducers? If so, re-apply transducers correctly according to directions in this book, or in the Instructions for Use accompanying the accessory.• Is the interference intermittent or constant?• Does the interference occur only in certain locations?• Does the interference occur only when in close proximity to certain medical electrical equipment?Once the source is located, there are a number of things that can be done to mitigate the problem:1Eliminating the source. Turn off or move possible sources of EMI to reduce their strength.2Attenuating the coupling. If the coupling path is through the patient leads, the interference may be reduced by moving and/or rearranging the leads. If the coupling is through the power cord, connecting the system to a different circuit may help.3Adding external attenuators. If EMI becomes an unusually difficult problem, external devices such as an isolation transformer or a transient suppressor may be of help. Your service provider can be of help in determining the need for external devices.Where it has been established that electromagnetic interference is affecting physiological parameter measurement values, a physician, or a suitably qualified person authorized by a physician, should determine if it will negatively impact patient diagnosis or treatment.
30 Specifications and Standards Compliance315System CharacteristicsThe phenomena discussed above are not unique to this system, but are characteristic of fetal patient monitoring equipment in use today. This performance is due to very sensitive high gain front end amplifiers required to process the small physiological signals from the patient. Among the various monitoring systems already in clinical use, interference from electromagnetic sources is rarely a problem.Electromagnetic Emissions and ImmunityThe EMC standards state that manufacturers of patient-coupled equipment must specify immunity levels for their systems. See Tables 1 to 4 for this detailed immunity information. See Table 5 for recommended minimum separation distances between portable and mobile communications equipment and the product.Immunity is defined in the standard as the ability of a system to perform without degradation in the presence of an electromagnetic disturbance.Caution should be exercised in comparing immunity levels between different devices. The criteria used for degradation are not always specified by the standard, and can therefore vary with the manufacturer.In the table below, the term "device" refers to the Avalon FM20/30/40/50 fetal monitor together with its accessories. The table gives details of the electromagnetic emissions, and how these are classified, for the device, and the electromagnetic environments in which the device is specified to technically function.Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic EmissionsEmissions Test Compliance Avoiding Electromagnetic InterferenceRadiofrequency (RF) emissions Group 1 The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.Harmonic emissions IEC 61000-3-2 Class AVoltage fluctuations and flicker IEC 61000-3-3 complies
30 Specifications and Standards Compliance3161 Note that the device is not intended for home use.Electromagnetic ImmunityThe monitor is suitable for use in the specified electromagnetic environment. The user must ensure that it is used in the appropriate environment as described below.RF emissions CISPR 11For the Avalon FM20/30 fetal monitor with all accessories except the IUP/ECG patient module M2738A.Class B The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes1.RF emissions CISPR 11For the Avalon FM40/FM50 with all accessories.For the Avalon FM20/30 fetal monitor whenever used with the IUP/ECG patient module M2738A.For the Avalon CTS Interface Cable (M2731-60001/M2732-60001) whenever used with the Avalon CTS Cableless Fetal Transducer System.For the Avalon CL Base Station with cableless transducers whenever used with the fetal monitors.Class A The device is suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage supply network that supplies buildings used for domestic purposes.Table 1 - Guidance and Manufacturer's Declaration: Electromagnetic EmissionsEmissions Test Compliance Avoiding Electromagnetic InterferenceTable 2 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityImmunity Test IEC 60601-1-2 Test LevelCompliance Level Electromagnetic Environment GuidanceElectrostatic discharge (ESD) IEC 61000-4-2±6 kV contact ±8 kV air±6 kV contact ±8 kV airFloors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.Electrical fast transient/burst IEC 61000-4-4±2 kV for power supply lines ±1 kV for input/output lines±2 kV for power supply lines ±1 kV for input/output linesMains power quality should be that of a typical commercial and/or hospital environmentSurge IEC 61000-4-5±1 kV differential mode ±2 kV common mode±1 kV differential mode ±2 kV common modeMains power quality should be that of a typical commercial and/or hospital environment
30 Specifications and Standards Compliance317Radio Compliance NoticeAvalon CL with WMTSOperation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service.This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any changes or modifications to this equipment not expressly approved by Philips Medical Systems may cause harmful radio frequency interference and void your authority to operate this equipment.Radio Information CanadaInstallation of this telemetry device is permitted in hospitals and health care facilities only. This device shall not be operated in mobile vehicles (including ambulances and other vehicles associated with health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The coordinates of DRAO are: latitude N 49E 19' 15", longitude W 119° 37 12. For medical telemetry systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300 (telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada, may be contacted.)Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycles<5% UT (>95% dip in UT) for 0.5 cyclesMains power quality should be that of a typical commercial and/or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device is powered from an uninterruptible power supply.40% UT (60% dip in UT) for 5 cycles40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles70% UT (30% dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 sec< 5%UT (>95% dip in UT) for 5 secPower frequency (50/60 Hz) magnetic field IEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial and/or hospital environmentKey: UT is the AC mains voltage prior to application of the test level.Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityImmunity Test IEC 60601-1-2 Test LevelCompliance Level Electromagnetic Environment Guidance
30 Specifications and Standards Compliance318Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.L'utilisation de cet appareil de télémesure est permise seulement dans les hôpitaux et établissements de soins de santé. Cet appareil ne doit pas être mis en marche dans des véhicules (y compris les ambulances et autres véhicules associés aux établissements de santé). La personne qui installe/utilise cet appareil doit s’assurer qu’il se trouve à au moins 80 km de l’Observatoire fédéral de radioastrophysique (OFR) de Penticton en Colombie-Britannique. Les coordonnées de l’OFR sont: latitude N 49° 19’ 15», longitude O 119° 37 12 . La personne qui installe/utilise un système de télémesure médicale ne pouvant respecter cette distance de 80 km (p. ex. dans la vallée de l’Okanagan (Colombie-Britannique), doit se concerter avec le directeur de l’OFR et obtenir de sa part une autorisation écrite avant que l’équipement ne puisse être installé ou mis en marche. Le directeur de l’ OFR peut être contacté au 250-497-2300 (tél.) ou au 250-497-2355 (télécopieur). (Le Directeur des Norm es réglementaires d’Industrie Canada peut également être contacté).Avalon CL with T108Japanese Radio Law and Japanese Telecommunications Business Law Compliance.This device should not be modified (otherwise the granted designation number will become invalid).Finding Recommended Separation DistancesIn the following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m).Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.Field strengths from fixed transmitters, such as land mobile radios, base stations for radio telephones (e.g. cellular, cordless), amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.Interference may occur in the vicinity of equipment marked with this symbol:
30 Specifications and Standards Compliance319Field strengths from fixed transmitters, such as base stations, or radio, (cellular, cordless) telephones, and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the Table 3 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityConducted RF Immunity Test EN/IEC 61000-4-6IEC 60601-1-2 Test Level over 150 kHz to 80 MHz Compliance LevelElectromagnetic Environment Guidance:Recommended Separation Distance (d)(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements3.0 VRMS 3.0 VRMS d = 1, 2PKey: d = Recommended separation distance in meters (m)P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturerV1 = Tested compliance level (in Volts) for the Conducted RF Immunity test IEC 61000-4-6The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency range. Over the frequency range 150 kHz—80 MHz, the recommended separation distance in meters (d) is found by the following equation:For a compliance level of 3.0 VRMS: d = 1, 2PTable 4 - Guidance and Manufacturer's Declaration: Electromagnetic ImmunityRadiated RF Immunity Test EN/IEC 61000-4-3IEC 60601-1-2 Test Level over 80 MHz to 2.5 GHz Compliance LevelElectromagnetic Environment Guidance:Recommended Separation Distance (d)(in Meters, at Frequency Range Tested) for Ultrasound and ECG Measurements3.0 V/m 3.0 V/m Over 80 MHz—800 MHz:d = 1, 2POver 800 MHz—2.5 GHz:d = 2, 3PKey: d = Recommended separation distance in meters (m)P = maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturerE1 = Tested compliance level (in Volts/meter) for the Radiated RF Immunity test IEC 61000-4-3The device meets the compliance level of 3.0 VRMS according to IEC 60601-1-2 over the specified test frequency range.Over the frequency range 80 MHz—800 MHz, the recommended separation distance in meters (d) is found by the following equation:For a compliance level of 3.0 VRMS: d = 1, 2POver the frequency range 800 MHz—2.5 GHz, the recommended separation distance in meters (d) is found by the following equation:For a compliance level of 3.0 VRMS: d = 2, 3P
30 Specifications and Standards Compliance320location in which the device is used exceeds the applicable RF compliance level above, it should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.If you require further information or assistance, please contact Philips Support.Recommended Separation Distances from Other RF EquipmentThe device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.Radio Frequency Radiation Exposure InformationThe radiated output power of the Avalon CL Transducer System is far below the FCC radio frequency exposure limits.CL Wide Range PodFor body worn operation, this device has been tested and meets FCC RF exposure guidelines when used in the standard configuration with the rear side towards the body, without a gap. Alternatively, it can be used with any accessory that positions the front side of the device a minimum of 10 mm from the body. The accessory itself must not contain any metal parts. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.Nevertheless it is strongly recommended to operate the CL Wide Range Pod with the rear side towards the body to achieve best possible radio performance.Table 5 - Separation Distance (d) in Meters According to Frequency of Transmitter at IEC 60601-1-2 Test Compliance LevelRated Maximum Output Power (P) of Transmitter (in Watts)150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz0.01 W d= 0.1 m d= 0.1 m d= 0.23 m0.1 W d= 0.4 m d= 0.4 m d= 0.7 m1 W d= 1.2 m d= 1.2 m d= 2.3 m10 W d= 3.8 m d= 3.8 m d= 7.3 m100 W d= 12.0 m d= 12.0 m d= 23.0 m
30 Specifications and Standards Compliance321EnvironmentBefore operation, make sure that the fetal monitor is free from condensation. This can form when equipment is moved from one building to another, and is exposed to moisture and differences in temperature.Use the monitor in an environment which is reasonably free from vibration, dust, corrosive or explosive gasses, extremes of temperature, humidity, and so forth. It operates within specifications at ambient temperatures between 0-+45°C (32°F-113°F). Ambient temperatures that exceed these limits can affect the accuracy of the system, and can damage the components and circuits.Ambient temperature ranges for storage are -20°C-+60°C (-4°F-140°F) for the monitor, and -40°C-+60°C (-40°F-140°F) for transducers.The transducers are watertight to a depth of 1.0 m for at least five hours (rated IP 68).WARNING•Leakage currents: If several items of equipment used to monitor a patient are interconnected, the resulting leakage current may exceed allowable limits.•ECG electrodes: NEVER allow ECG electrodes to contact other electrical conductive parts, including earth.Monitoring After a Loss of PowerIf the monitor is without power for less than one minute, monitoring will resume with all active settings unchanged. If the monitor is without power for more than one minute, the behavior depends on your configuration. If Automat. Default is set to Yes, the User Defaults will be loaded when power is restored. If Automat. Default is set to No, all active settings are retained, if power is restored within 48 hours. The Automat. Default setting is made in Configuration Mode.FM20/30 with BatteryOption,FM40/50When power is lost - no power is available from the AC power source, or from the battery - a beeper will sound. The tone can be silenced by pressing the On/Standby button.ESU, MRI, and DefibrillationWARNINGThe fetal/maternal monitors are NOT intended for use during defibrillation, electro-surgery, or MRI. Remove all transducers, sensors, and accessories before performing electro-surgery, defibrillation, or MRI, otherwise harm to the patient or the user can result.
30 Specifications and Standards Compliance322Cardiac Pacemakers and Electrical StimulatorsWARNINGThe fetal/maternal monitors are not intended for use for ECG measurements on patients connected to external electrical stimulator, or with cardiac pacemakers.Fast Transients/BurstsThe equipment will return to the previous operating mode within 10 seconds without loss of any stored data.Symbols on the SystemThese symbols can appear on the monitor and its associated equipment and packaging.Symbol DescriptionThis safety symbol indicates that you have to consult the Instructions for Use (this document), and particularly any warning messages. The symbol can be also printed out black and white.This symbol indicates that you have to consult the Instructions for Use (this document).This symbol indicates that you should consult the Instructions for Use (this document).Power-On/Off Switch - FM20/FM30 without Battery OptionPower-On/StandBy button - FM40/FM50 and FM20/30 with Battery OptionPower-On LEDElectrical Class II equipment, in which the protection against electric shock relies on double or reinforced insulation (FM20/FM30)Fetal Sensor Socket symbolSpO2 Socket symbol
30 Specifications and Standards Compliance323Noninvasive Blood Pressure Socket symbolType BFSymbol indicating the monitor has the triplets optionSymbol indicating the monitor is capable of intrapartum monitoringButton to open paper drawer/paper eject. (FM40/FM50)Protective earth terminal (FM40/FM50)Equipotential grounding point (FM40/FM50)Socket for connecting Avalon CTS interface cable M2732-60001 or Avalon CL interface cable (with black connector, FM40/FM50)Symbol indication for non-ionizing radiationConnection direction indicator FM20/FM30 with battery optionMouse connection indicator (optional)Keyboard connection indicator (optional)Serial/MIB connector (optional)USB interface (optional)Video Analog interface indicator for connection to any analog video display (VGA resolution) FM40/FM50IP 67 Ingress Protection code according to IEC 60529. The IUP/ECG patient module (M2738A) is rated IP 67 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 0.5 meter for 30 minutes)Symbol Description
30 Specifications and Standards Compliance324IP 68 Ingress Protection code according to IEC 60529. All transducers (excluding M2738A) are rated IP 68 (protection against dust, access to hazardous parts, and the effects of continuous immersion in water to a depth of 1.0 meter for five hours)IP X1 Ingress Protection code according to IEC 60529. The monitors and interface cable for the Avalon CTS (M2731-60001/M2732-60001) are rated IP X1 (protection against water dripping vertically only)IP 31 Ingress Protection code according to IEC 60529 (protection against condensation only)IP 21 Ingress Protection code according to IEC 60529 (protection against ingress of water when the water is dripping vertically)Type CF equipment, not defibrillation proofIndicates location of service numberIndicates location of serial numberIndicates location of catalog numberIndicates location of the date of manufacture and/or name and address of manufacturerIdentifies year and month of manufactureChina RoHSSymbol indicating separate collection for waste electrical and electronic equipmentEAC markCSA US markFCC ID Federal Communications Commission: FCC ID xxxxCMIIT ID Chinese Radio marking: CMIIT ID (China Ministry of Industry and Information Technology)CE marking accompanied by the Notified Body number 0123Industrial, Scientific, & Medical radio frequency band (Avalon CL frequency band used e.g. in the EU)Symbol Description
30 Specifications and Standards Compliance325Association Of Radio Industries And Businesses T108 (Avalon CL frequency band used e.g. in Japan)Wireless Medical Telemetry Service (Avalon CL frequency band used e.g. in North America)Symbol DescriptionIC-ID (Industry Canada ID)One IC-ID labeling for each built in radio: OBR, SRR Japanese Radio marking: Radio mark + [R]-symbol + IDTaiwan Radio Label (NCC Logo) + ID Korea radio mark: KC logo, KCC ID number, and Conformity assessment information
30 Specifications and Standards Compliance326
3132731Default Settings AppendixThis appendix documents the most important default settings of your fetal monitor and the Avalon CL Base Station with the cableless transducers as they are delivered from the factory. For a comprehensive list and explanation of default settings see the Configuration Guide supplied with your fetal monitor. The monitor's default settings can be permanently changed in Configuration Mode.Alarm and Measurement Default SettingsAlarm Defaults SettingsAlarm Settings Choice DefaultAlarm Mode INOP only, All INOP only (international)All (USA/CAN)Alarm Volume0..10 5Alarms Off 1 min, 2 min, 3 min, Infinite 2 minAlarm Text Standard/Enhanced StandardVisual Latching Red & Yellow/Red Only/Off Red & YellowAudible Latching Red & Yellow/Red Only/Off Red & YellowAlarm Sounds Traditional/ISO TraditionalAlarm Low0..10 4Fetal / Maternal Defaults Settings (International)FHR, dFHR, aFHRAlarms On/Off DefaultOnDefault Color for FHR Numeric (for all FHR numerics)OrangeToco, aTocoDefault color for Toco numericGreenIUPDefault IUP Scale UnitmmHgDefault color for IUP numericGreenHR, aHR Measurement Default Color for MECG NumericRed
31 Default Settings Appendix328Coincidence Default SettingsNBP Default SettingsFetal / Maternal Defaults Settings (US/CAN)FHR, dFHR, aFHRAlarms On/Off DefaultOnDefault Color for FHR Numeric:FHR1, dFHR1, aFHR1 FHR2, dFHR2, aFHR2 FHR3, dFHR3, aFHR3Red Blue GreenToco, aTocoDefault color for Toco numericGreen (Toco) Yellow (aToco)IUPDefault IUP Scale UnitmmHgDefault color for IUP numericWhiteHR, aHR Measurement Default Color for MECG NumericRedCoincidence Default SettingsCoincidence Tone immediatelyFactory Default Settings Mode ManualRepeat Time 15 minAlarms from Sys. (International)Sys&Dia&Mean (USA/CAN)NBP Sys/Dia only Yes (International)No (USA/CAN)Low Limit90/50 (60)High Limit160/90 (110)VP Pressure60 mmHgDone Tone OffVeni Puncturen/aStart Time SynchronizedNBP OnAlarms OnColor RedReference Auscultatory
31 Default Settings Appendix329CL NBP Default SettingsSpO2 Default SettingsNBP Settings Factory DefaultsMode AutoRepeat Time 10 minNBP OnVP Pressure 60 mmHgReference AuscultatoryUnit mmHgDone Tone OffStart Time SynchronizedAging Time 10 minColor RedSpO2 Factory Default SettingsDesat Limit80Low Limit90High Limit100Desat Delay20 secondsLow Alarm Delay10 secondsHigh Alarm Delay10 secondsAverage10 secondsNBP Alarm Suppr. OnAlarms OnColor CyanPulse Default SettingsPulse (SpO) OnHigh Limit120 bpmLow Limit50 bpm ExtrBrady Bradycardia: Difference to Low Limit 20 bpmBrady Clamp40 bpm ExtrTachy Tachycardia: Difference to High Limit 20 bpmTachy Clamp200 bpm
31 Default Settings Appendix330CL SpO2 Default SettingsTympanic Temperature Default SettingsManually Entered Values Default SettingsRecorder Default SettingsSpO2 Settings Factory DefaultsRepeat Time 15 minSignal Quality OnNBP Alarm Suppr. OnColor CyanpTemp Settings Factory defaultsAdultLow Limit36°C (96.8°F)High Limit39°C (102.2°F)Unit °CAlarms OnColor WhiteManual Entered Values Default SettingsLabel Temp (fixed)Unit °CColor WhiteInterval 1 hMsmnt OffSetting Choice DefaultRecorder Speed1, 2, or 3 cm/min 3 cm/minScale Type US, Internat'l USTrace Style FHR1 Thin, Medium, Thick, Extra Thick ThickTrace Style FHR2 MediumTrace Style FHR3 Extra ThickTrace Style Toco ThickTrace Style HR ThinWave Style ECG ThinECG Wave printing choiceSeparate, Overlap Separate
31 Default Settings Appendix331Notes Recording Along, Across Along (International) Across (USA/CAN)Change Rec Speed Monitoring, Config ConfigAuto Start Off, On OffConfirmed Stop OffBridge Paperout OnPaper Save Mode Off (International) On (USA/CAN)NST Autostart OnNST Autostop OffTrace Separation OffSeparation Order Standard, Classic Standard (International) Classic (USA/CAN)Intensity4 (medium) n/aCal. Offset5 n/aSetting Choice Default
31 Default Settings Appendix332
3331IndexAaccessories 275, 276, 277, 278, 279, 280, 285Avalon CL base station 275cl NBP Pod accessories 280cl SpO2 Pod accessories 284fetal accessories 276electrode patch 276fetal recorder accessories 285latex information 275MECG accessories 277noninvasive blood pressure accessories 278, 279adult cuffs 279multi-patient comfort cuff kits 278reusable cuffs 278single-hose disposable cuffs 279SpO2 accessories 280Philips sensors (disposable) 280Philips sensors (reusable) 280transducer accessories 276tympanic temperature 285tympanic temperature accessories 285ACOG technical bulletin 60actions after monitoring 70adjusting display 49admitting a patient 147, 148auto free 26editing information 148OB TraceVue/IntelliSpace Perinatal 149quick admit 148aging numerics 238alarms 117, 119, 120, 121, 122, 123, 124, 126, 128, 129, 197, 198, 240, 246, 298, 304, 305, 327acknowledging alarms 121active alarms 117alarm behavior at on/off 128alarm latching 127alarm limit delay 300alarm reminder 122alarm standards 119audible alarm indicators 119changing alarm delays 198high priority alarms 117latching alarms 126, 127latching alarm behavior 127pausing alarms 122red alarms 117restarting paused alarms 123reviewing alarms 126reviewing alarms window 126standard philips alarms 120yellow alarms 117applying the fetal & maternal pod 100artifact suppression 204artifact suppression and fetal arrhythmia 204explanation of artifact suppression 204switching on and off artifact suppression 204Bbaseline measurement 185, 192, 208Battery Option 109using batteries 109belt actions 50, 51, 52belt fastening 50, 51belt fixing button 51Ccableless monitoring 73Avalon CL 73cableless transducers 84assignment 99audio signal 87cl belt clip 88connector cap 85LED indication 86radio range 87cl pods 92audio signal 93battery status LED 93configuration cableless system 75important considerations 167LED indication 86paging patients 93prompts 96Tele Info window 94Telemetry 95Underwater monitoring 108calibration 241, 268calibrating noninvasive blood pressure 268cautions 9changing FHR alarm delays 198changing FHR alarm limits 197CL Fetal & Maternal Pod 89applying 100CL Wide Range Pod 91cleaning monitor actions 261, 262, 263, 273cleaning method 262cleaning monitoring accessories 263general cleaning requirements 261infection control 261printhead cleaning 273configuration mode 44configuring alarm tone 119confirming fetal life 10, 166, 183, 191cross-channel verification 10, 183, 191, 222CCV and triplets 191CCV and twins 183coincidence examples 162comparing FHR with MHR 160functionality 160misidentification of heart rates 159overview 161recommended actions 164Ddata recovery 257date from OB TraceVue/IntelliSpace Perinatal System 47date setting 47Dawes/Redman 22DECG 202, 205, 298DECG INOPs 205DECG specifications 298DECG testing 205DECG troubleshooting 205default settings 298alarm default settings 327FHR default settings 298IUP default settings 298MECG default settings 298noninvasive blood pressure default settings 304recorder factory default settings 308SpO2 factory default settings 305Toco default settings 298user defaults 46defibrillation precautions 225, 275, 321demo mode 44device classification 18disabling touchscreen 44discharging a patient 148disinfecting 261, 262, 263infection control 261recommended substances 263
334display 49, 238, 298adjusting display 49adjusting screen brightness 47display noninvasive blood pressure 238fetal display specifications 298disposal of electronic waste 274disposal of monitor 274dyshemoglobins 244intravascular dyshemoglobins 244Eearly systolic blood pressure 238ECG 202, 222, 298ECG specifications 298electrical safety tests 312electrical surgery precautions. See ESU 225, 244, 275, 321electrodes 224applying electrodes 224EMC 313electromagnetic compatibility 313electromagnetic emissions 315electromagnetic interference 314how to reduce electromagnetic interference 314EMC and compliant accessories 313EMC precautions 313EMC standards 313entering notes 42ESU precautions 225, 275, 321extension cable for SpO2 244external monitoring 165, 184, 192, 208external monitoring - Toco 208external monitoring - triplets 192external monitoring - twins 184external monitoring - ultrasound 165FFAST 243Fourier Artifact Suppression Technology 243fetal accessories 276fetal arrhythmia 204fetal demise 10fetal display specifications 298IUP - fetal display specifications 298Toco - fetal display specifications 298US - fetal display specifications 298fetal heart rate alerting. See FHR 197fetal heart rate. See FHR 165fetal movement 170fetal movement profile. See FMP 165FHR 10, 166, 172, 183, 185, 191, 192, 197, 198, 222, 298alerting 197cross-channel verification 222misidentification 10trace separation 185, 192FHR alarms 298finder LED 36, 53, 183, 191finding monitor revision 48flexible nurse call 25, 32, 35FMP 170, 171FMP and twins 170FMP statistics 171functional arterial oxygen saturation 243Gglobal settings 46Iinfection control 261infection and sterilizing 261INOPs 117, 121CCV INOPcoincidence tone 24disconnect INOPs 121INOP alarms 117red or yellow INOPs 24, 25INOPs indicators 117silencing INOPs 121interference 313, 314how to reduce interference 314interference from RF equipment 313internal monitoring 185, 199, 213intrauterine pressure. See IUP 211intravascular dyshemoglobins 244intravascular dyshemoglobins effects on (SpO2) 244IUP 211, 213, 298IUP specifications 298Mmains power (AC) 71disconnecting from mains power 71maintenance 267, 268maintenance schedule 267, 268visual inspection 267manual data entry 254maternal ECG 204, 225, 227electrode position 225printing waveform 204, 227viewing waveforms 225maternal heart rate 221, 222maternal heart rate and cross-channel verification 222maternal heart rate and priorities 221maternal heart rate from MECG 222sources of maternal heart rate 221maternal HR 166, 221, 222, 224Maternal HR from MECG 222Maternal HR priorities 221Maternal HR sources 221maternal temperature 23measurement settings 46changing measurement settings 46entering setup menu 46measurements 45, 46, 295setting up measurements 46switching on and off measurements 45MECG 204, 222, 224, 225, 227, 229, 231, 277, 298accessories 277alarm limits 300connection illustration 222default settings 298electrodes 224specifications 298waveform printing 204, 227MECG alarm limits 298methemoglobin (SpO2) 244monitor settings 10, 31, 47, 48, 49, 71, 257changing monitor settings 47major parts and keys 31power on/off behavior 71Standby 71starting monitoring 168switching on 48, 49monitoring mode 44monitoring triplets and FHR 191monitoring twins and FHR 183MR imaging and the SpO2 transducer 244MRI precautions 225, 275, 321NNBP. See noninvasive blood pressure 235NIBP. See noninvasive blood pressure 235Noninvasive Blood Pressure (NBP) 228, 235, 236, 237, 238, 239, 240, 241, 242, 268, 278, 279, 304automatic noninvasive blood pressure repeat time 239calibration interval 268comfort cuff kits 278factory defaults 304how the measurement works 235measurement 236, 239limitations 236methods 236starting 239stopping 239NBP accessories 278NBP adult cuffs 279NBP automatic mode 239NBP configurable measurement
335sequence 25NBP numerics 238NBP pediatric cuffs 279NBP performance specifications 304NBP reusable cuffs 278NBP single-hose disposable cuffs 279NBP site inspection 237NBP troubleshooting 242NBP venous puncture 241preparing to measure NBP 237non-medical devices 312non-medical devices in patient vicinity 312Non-Stress Test timer. See NST timer 152NST ReportTrace Interpretation 153, 157NST timer 151, 152OOB TraceVue 29, 30, 258connection to OB TraceVue/IntelliSpace Perinatal System 29, 30LAN connection 258operating modes 44configuration mode 44demo mode 44monitoring mode 44service mode 44operating temperatures 321oscillometric measurement method 235PPaging Patient 93paper 60, 61, 62, 65, 272, 285default recorder speed 60loading paper 62, 65paper out INOP 62paper speed 60changing 60default 60defaults 60setting 60paper, when to reload 62recorder paper 285removing paper 62, 65storing paper 272tearing off a trace 61Paper Advance key 42Paper-Out indication 62passcode protection 44patient alarms 129Patient Demographics window 147patient module 202, 222paused alarms 122, 123restarting paused alarms 123performance specifications 295, 304, 305noninvasive blood pressure specifications 304SpO2 specifications 305physiological alarms 117pop-up keys 96power 71disconnecting from 71power failure 72power on/ power off behavior 71pulse 228pulse from noninvasive blood pressure 228pulse rate 221QQRS tone pitch 247Rrecorder 56, 72, 272, 273, 285, 308factory defaults 308paper storage 272printhead cleaning 273recorder paper 285recorder specifications 308recorder troubleshooting 72recording elements 59recording stored data 42recovering traces 257trace recovery printout 257recycling 274regulatory compliance 311remote event marker 60Ssafety 268, 311maintenance interval 268safety information 13safety standards 311screen layouts 45selftest 48, 49, 56, 128sensor 243disposable SpO2 sensors 243selecting SpO2 sensors 243separating FHR traces 185, 192separating triplet traces 192separating twin traces 185service mode 44settings 45, 46, 47active settings 45changing settings 47factory default settings 46global settings 46monitor settings 47user default settings 46short range radio 92, 317, 320signal loss delay 198signal quality 70, 246signal quality during monitoring 70signal quality of SpO2 246silencing alarms 121specifications 289, 295, 298, 308built-in recorder specifications 308DECG specifications 298ECG specifications 298IUP specifications 298measurement specifications 295MECG specifications 298performance specifications 295, 298Toco specifications 298transducer specifications 289US specifications 298SpO2 243, 244, 246, 280, 305accessories 280alarm specifications 305connecting the cables 244disposable sensors 243factory defaults 305FAST technology 243performance specifications 305Philips sensors (disposable) 280Philips sensors (reusable) 280signal quality 246tone modulation 247SpO2 alarms 246, 305standards 311, 313EMC standards 313safety standards 311standards compliance 311Standby 42starting monitoring 48sterilizing 261, 265infection control 261storage temperatures 321stored data recording 42suppressing artifacts 204suspended alarm 123suspicious SpO2 reading 246switching on and off 171switching on and off alarms 124switching on monitor 48, 49switching on recorder 56symbols on the system 322Ttechnical alarm messages. See INOPs 132temperatures 321operating temperatures 321storage temperatures 321
336testing 128, 205, 229, 312DECG testing 205MECG testing 229safety testing 312testing alarms 128time 47setting time 47time from OB TraceVue/IntelliSpace Perinatal System 47Toco 202, 207, 208, 210, 224, 298default Toco settings 298testing a Toco transducer 210Toco baseline 208Toco display specifications 298Toco monitoring 207Toco sensitivity 208Toco specifications 298Toco MP transducer 207, 221Toco+ transducer 207tone modulation (SpO2) 247touch tone volume 47touchscreen operation 38, 44trace actions 61, 257, 258tearing off traces 61trace recovery on OB TraceVue/IntelliSpace Perinatal System 258trace recovery on paper 257transducer 36, 51, 53, 173, 183, 191, 207, 210, 289connecting transducer to monitor 53fixing transducer to belt 51repositioning transducers 53Toco transducer 207Toco+ transducer 207transducer belt clip 51transducer specifications 289transducer testing 173, 210Toco 210ultrasound 173triplets 191, 192, 193, 194, 196cross-channel verification 191external monitoring 192importance of monitoring MHR 191monitoring triplets 191offsetting baselines 192troubleshooting 72, 172, 189, 196, 205, 208, 214, 227, 242DECG 205FHR 172IUP 214MECG 227twins 170, 183, 184, 185, 186, 187, 189cross-channel verification 183external monitoring 184importance of monitoring MHR 183invasive monitoring 185monitoring FHR 183monitoring twins 183offsetting baselines 185twins and FMP 170Tympanic Temperature 249body reference sites 254display and controls 250manual data entry 254status screens 251taking temperature 252tympanic temperature accessories 285Uultrasound 165, 168, 173, 298applying gel 168testing a transducer 173ultrasound display specifications 298ultrasound monitoring 165ultrasound specifications 298understanding screens 45USB 25using the adapter cable 202uterine activity 202, 207, 208, 211, 213, 214, 224external monitoring 207internal monitoring 211monitoring uterine activity 202, 208, 211, 213, 224troubleshooting uterine activity 208, 214Vvelcro belt 52venous puncture 241visual alarm indicators 119volume 47, 120alarm volume 120IUP, zeroing 213touch tone volume 47Wwarnings 9
Part Number 453564659391 Published in Germany 09/16*453564659391*

Navigation menu