ZOLL MTPCIE-BW-A MTPCIE-BW User Manual

ZOLL Manufacturing Corporation MTPCIE-BW

user manual

® ® Model 5000 Patient Manual 20 B0060 Rev A - P 1
Contents i Restricted sale Federal (USA) law restricts this device to sale by or on the order of a physician. Effectivity This manual describes the LifeVest 5000 wearable defibrillator system. Disclaimer Information, operation, specifications, and product appearance may change without notice. Names and data used in examples are fictitious. Trademarks ZOLL, LifeVest, Blue and the color Blue are trademarks and/or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. Copyright notice © 2016 ZOLL Medical Corporation. All rights reserved. Patents Patent: www.zoll.com/patents Software nonexclusive license The LifeVest device includes certain software (“Software”). ZOLL grants you a nonexclusive license to use the Software solely for diagnostic and treatment purposes as part of use of the LifeVest device. You are prohibited from: ( i) reproducing the Software; ( ii) removing or destroying any proprietary markings, copyright notices or other legends which are part of the Software; ( iii) modifying or reverse engineering the Software; or ( iv) removing the Software from the LifeVest device. Title to the Software will remain at all times with ZOLL. You must keep the Software confidential.
LifeVest 5000 Patient Manual ii Contact information ZOLL Pittsburgh, PA 15238 USA Phone toll free (USA and Canada ) Phone outside USA Fax Web 1-800-543-3267 1-412-968-3333 1-412-826-9485 www.zoll.co m
Contents Contents 1: Introduction .............................................................................................................................1-1 About this manual ................................................................................................................................. 1-1 About the LifeVest system and cardiac defibrillation ........................................................................... 1-1 How the LifeVest works ........................................................................................................................ 1-1 Safety information ................................................................................................................................ 1-2 Environment considerations related to noise and vibration ................................................................ 1-5 Intended use locations .......................................................................................................................... 1-5 Essential performance........................................................................................................................... 1-5 Aircraft use ............................................................................................................................................ 1-5 Operator profile .................................................................................................................................... 1-6 Patient profile ....................................................................................................................................... 1-6 ZOLL authorized representative profile ................................................................................................ 1-6 Patient training ...................................................................................................................................... 1-6 Electromagnetic interference ............................................................................................................... 1-7 Wireless interference ............................................................................................................................ 1-8 FCC regulatory information ................................................................................................................... 1-8 2: Meet the LifeVest 5000 system..................................................................................................2-1 Components .......................................................................................................................................... 2-1 Garment and electrode belt .................................................................................................................. 2-2 Monitor — front view ........................................................................................................................... 2-3 Monitor — back view ............................................................................................................................ 2-4 Monitor touchscreen ............................................................................................................................ 2-5 Help screens .......................................................................................................................................... 2-7 Charger .................................................................................................................................................. 2-8
3: Using the LifeVest .....................................................................................................................3-1 Daily routine .......................................................................................................................................... 3-1 Normal startup routine ......................................................................................................................... 3-2 Battery care ........................................................................................................................................... 3-3 Charger setup ........................................................................................................................................ 3-4 Change and charge batteries daily ........................................................................................................ 3-7 Record your heart rhythm (ECG) ........................................................................................................... 3-8 Patient menu screen ............................................................................................................................. 3-9 Voice options ....................................................................................................................................... 3-10 Sending data manually ........................................................................................................................ 3-11 Airplane mode ..................................................................................................................................... 3-13 WiFi ..................................................................................................................................................... 3-15 System information ............................................................................................................................. 3-23 Support mode ..................................................................................................................................... 3-24 Periodically clean and inspect the system .......................................................................................... 3-26 What family members need to know .................................................................................................. 3-27 When you are finished with the device .............................................................................................. 3-28 4: Garment and electrode belt ......................................................................................................4-1 Assemble the garment and electrode belt ............................................................................................ 4-1 Assembled garment and electrode belt ................................................................................................ 4-3 Putting on the assembled garment and electrode belt ........................................................................ 4-4 Connecting and disconnecting the electrode belt ................................................................................ 4-7 iii
LifeVest 5000 Patient Manual iv Remove when showering and bathing .................................................................................................. 4-8 Disassembling the garment and electrode belt .................................................................................... 4-9 Laundering the garment ...................................................................................................................... 4-10 5: Responding to alerts .................................................................................................................5-1 Overview of alerts ................................................................................................................................. 5-1 Physiological alerts: vibration or siren sound ....................................................................................... 5-1 Siren with call for help message ............................................................................................................ 5-4 Technical alerts: gong sound ................................................................................................................. 5-5 Informative alerts: gong or high-pitched “train whistle” sound ........................................................... 5-6 6: Using the activities options .......................................................................................................6-1 Introduction to activities ....................................................................................................................... 6-1 Taking the health survey ....................................................................................................................... 6-2 Taking the health survey now ............................................................................................................... 6-3 Taking the WalkTest™ ........................................................................................................................... 6-7 Taking the WalkTest™ now ................................................................................................................... 6-9 Appendix A: Symbols and Icons ..................................................................................................... A-1 Appendix B : Software Licensing Statement ................................................................................... B-1 NO WARRANTY ..................................................................................................................................... B-1
Introduction 1-1 1: Introduction About this manual This manual: • is for patients who are using the LifeVest wearable defibrillator. • gives you instructions on the use and care of the device. • is intended to supplement the training you received when you were fitted with the LifeVest device. About the LifeVest system and cardiac defibrillation The LifeVest device continuously monitors your heart. If it detects a life threatening rhythm that is too fast, the device delivers treatment to restore normal rhythm. If you are conscious, you can prevent a treatment by using the response buttons when the device alerts you that a treatment is coming. How the LifeVest works The round electrodes in the garment monitor your heart. Therefore, it is important to maintain a snug fit across your chest. If the LifeVest detects a possible life threatening rhythm, the device will first create a vibration in the middle of your back to warn you of a possible treatment. The siren alert then occurs to inform you that the LifeVest is about to deliver a treatment, a therapeutic dose of electrical energy, in an attempt to restore your normal heart rhythm. If you are conscious: To prevent a treatment from occurring, press the response buttons on the monitor. You may release the buttons, but must repeat pressing them each time the siren alert occurs. Pressing the buttons tells the device that you are conscious. If you are unconscious: The response buttons will not be pressed, which tells the LifeVest to prepare to deliver a treatment. The monitor will then play an auditory message to inform bystanders to not interfere while the treatment is delivered.
LifeVest 5000 Patient Manual 1 - 2 Safety information This information helps you safely operate the LifeVest device. Read and understand these warnings, cautions, and symbols before using the device. • Conductive parts of electrodes and associated connectors should not contact other conductive parts including earth. • If the charger or power supply makes unusual noises, sparking, starts to smoke, or emits a burning smell, unplug it immediately from the wall outlet. The only way to completely remove power is by unplugging the AC power plug from the wall outlet. • Any medical electrical equipment connected to the patient at the same time as the LifeVest must be defibrillator proof, as shown by this symbol. If the equipment is not defibrillator proof, the equipment may be damaged if the LifeVest delivers a treatment. Disconnect any non-defibrillator proof equipment from the patient while the patient is wearing the LifeVest. Terms used WARNING: Warns of possible injury or death that can be caused by misuse of the device. This includes device failure that could result in the inability of the device to protect you. CAUTION: Advises of possible problems that include damage to the device or other property, or minor injury. WARNINGS Do not use the LifeVest System until you receive training and understand the manual. If you do not understand how to use the system, you may damage it and/or cause the system to malfunction. Always wear the LifeVest when instructed to do so by a medical professional. Make sure the electrode belt is properly connected to the monitor. Inappropriate use of the LifeVest may damage it and/or cause the system to malfunction. Do not tamper, alter, drop or abuse any part of the system or labeling. Altering the equipment in any way may damage it and/or cause the system to malfunction. Do not disassemble the unit. A shock hazard exists. Refer all servicing to qualified personnel. Do not put the monitor, electrode belt, battery or charger in or near water. Water entering the device may damage it and/or cause the system to malfunction.
Introduction 1-3 WARNINGS Always operate the system within the range of 0°C to 50°C (32°F to 122°F), up to 95% relative humidity (non-condensing), and up to 10,000 feet in altitude. Operating the device outside of this range may damage it and/or cause the system to malfunction. Do not use the device in the presence of flammable agents or in an oxygen enriched atmosphere. This could present an explosion and fire hazard. If you see Blue™ gel other than during a treatment, this may indicate a damaged electrode belt and cause the system to malfunction. Call ZOLL LifeVest immediately. If the therapy pad Blue™ gel gets into your eyes, flush your eyes immediately with water and contact your physician. Your eyes may become irritated from the Blue™ gel. The LifeVest is magnetic resonance (MRI) unsafe. Do not use it in an MRI imaging environment. Do not stack or place the LifeVest next to other devices. Doing so could expose the device to EMI disturbance that may cause the system to malfunction. Only the patient should press the response buttons. The patient’s ability to press the response buttons lets the device know whether or not the patient is conscious and is critical in deciding when to give the patient a treatment. If anyone other than the patient presses the response buttons, needed therapy may not be delivered, possibly resulting in serious injury or death. Do not touch the patient while a treatment is being delivered. Anyone touching the patient during a treatment may be shocked. Do not remove the battery, do not disconnect the electrode belt from the monitor, and do not loosen the garment while the monitor is broadcasting alert sounds and/or voice prompts. If the battery is removed, the electrode belt disconnected from the monitor, or the garment is loosened, needed therapy may not be delivered, possibly resulting in serious injury or death. CPR can be performed as long as the monitor is not broadcasting alert sounds and/or voice prompts. If external defibrillation is available, a decision can be made by a medical professional to remove the device and monitor/treat the patient with external equipment. Do not dispose of or incinerate the batteries. The batteries contain lithium ion and must be disposed of properly by ZOLL. Do not force the connector. Allow the connector to align before pushing it in. Forcing the connector may damage it and cause the system to malfunction. Do not use chlorine bleach, bleach alternatives, fabric softener, anti-static sprays or detergents that include bleach or fabric softener additives when laundering the garment. Using bleach or any of these other prohibited agents to launder the garment may damage it and cause the system to malfunction.
LifeVest 5000 Patient Manual 1 - 4 WARNINGS If you get an alert sound and you are awake, always press the response buttons to prevent receiving a treatment. If you fail to press the response buttons, you will get a treatment. If you receive a treatment while your heart is beating normally and you did not use the response buttons, the treatment may cause an abnormal rhythm to occur. There is a small possibility that the abnormal heart rhythm may not be detected and death may result. If you get the siren alert, stop walking and press the response buttons. When performing the WalkTest™, do not continue walking if the monitor broadcasts an alert sound. Stop walking and press the response buttons as you normally would. If you continue walking, you may place yourself at risk for a cardiac arrest, possibly resulting in serious injury or death. When performing the WalkTest™, do not continue walking if you experience symptoms such as shortness of breath, chest pain, or other pain or discomfort. Stop walking and sit or lie down. If the symptoms continue or get worse, immediately call your doctor or emergency help. If you continue walking or ignore the symptoms, you may place yourself at risk for a cardiac arrest or other health problems, possibly resulting in serious injury or death.
Introduction 1-5 Indications for use The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. The LifeVest system is indicated for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Patients must have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75 kilograms (41.3 pounds) or greater. Environment considerations related to noise and vibration Certain environments or situations you encounter that are loud and have high vibration could affect the LifeVest. A loud environment could make it difficult for you to hear an alert to be able to appropriately respond. A high vibration environment may result in an inappropriate treatment. For example, riding a motorcycle or using some lawnmowers may cause vibration and make it difficult for some patients to hear an alert which may result in an inappropriate treatment. If you encounter a loud, high vibration environment while wearing the LifeVest, you should be attentive to your device to ensure you respond to any alerts. In the unlikely event that vibration causes you to receive a siren alert, press the response buttons to prevent receiving a treatment and move away from the source of vibration. Intended use locations The intended electromagnetic environments for the LifeVest 5000 wearable defibrillator are home, small clinic, hospital, and transport. Essential performance The essential performance of the LifeVest is that it detects ventricular fibrillation or ventricular tachycardia, then delivers a treatment. Unacceptable risks include loss of detection and treatment functionality. Aircraft use The LifeVest 5000 was tested to demonstrate compliance to the emissions and immunity requirements of the following standard: RTCA DO-160F, Environmental Conditions and Test Procedures for Airborne Equipment, Section 20 (RF immunity) and Section 21 (RF emissions). Check with the airline for any special restrictions on using personal electronic equipment when making flight reservations. The Airplane mode feature disables the LV5000 from communicating wirelessly. Use this option when on an airplane or in any environment where cellular phone use is prohibited.
LifeVest 5000 Patient Manual 1 - 6 Operator profile As defined by IEC 60601-1-6, the operator profile is a summary of the mental, physical, and demographic traits of the intended user population. According to the IEC definition, the operator is defined as the person interacting with the device. In the case of the LifeVest, there are two operators: • The patient wears and interacts with the LifeVest on a daily basis. The patient profile appears below. • ZOLL authorized representatives fit patients with the equipment, and train patients. The ZOLL authorized representative profile appears below. Patient profile The device is appropriate for patients who are at risk for sudden cardiac arrest and meet the requirements described in the Patient Manual. ZOLL authorized representative profile ZOLL authorized representatives are ZOLL-trained professionals. Their job is to program the equipment according to the patient’s prescription, measure and fit patients with the LifeVest equipment, train patients and family members, and provide follow-up assistance if necessary. ZOLL authorized representatives must have the mental and physical capabilities to understand training given by ZOLL that covers programming the device, measuring and fitting patients, and training patients in the daily use of the device. Patient training It is essential that all patients receive training before wearing the LifeVest. This training is given by ZOLL authorized representatives. These representatives deliver the LifeVest training in the patient’s home or in a clinical setting. Patient training consists of instructions for garment and electrode belt assembly and disassembly; alert response, including the use of the response buttons; and how to change and recharge the batteries. After completing the training, patients sign an agreement that documents receipt of training in the use and care of the LifeVest. In addition, phone support is available for patients by calling ZOLL or a ZOLL representative. See page ii, for the ZOLL phone support number.
Introduction 1-7 Electromagnetic interference Many common devices, including motors and electronic equipment, could produce electromagnetic interference, also known as EMI, in the LifeVest device that could affect its operation. The LifeVest device has been tested with a number of common sources of electromagnetic disturbance, including cellular telephones, airport security systems, and anti- theft detection systems. This testing, along with clinical trial testing, has demonstrated that in everyday use the LifeVest device is not normally affected by commonly encountered electromagnetic disturbances. Anti-theft detection systems, also known as electronic article surveillance systems, are often used in department stores and libraries to prevent theft by electronically sensing a special tag on a piece of merchandise when the tag passes through a detector gate. In the USA, these detector gates are commonly located near the doorways. In Europe, the detector gates may be positioned near the checkout areas. To prevent possible disturbance with the LifeVest device, follow these simple guidelines when passing through airport security gates or anti-theft detection gates: • Walk through the gate at a normal pace. • Avoid lingering near or leaning on the gate. In some occupational and hospital environments, unusually high levels of electromagnetic disturbance could be encountered. Examples of possible sources of such disturbance include: Magnetic resonance (MR) imaging equipment, communication equipment such as microwave transmitters, arc welding equipment, high voltage transmission lines, electrocautery systems, and electronic muscle stimulators. These environments should be avoided while wearing the LifeVest device. In the unlikely event that electromagnetic disturbance causes you to receive arrhythmia alerts, press the response buttons to prevent being shocked and move away from the source of the disturbance. The LifeVest device should return to normal monitoring mode in approximately 5 seconds.
LifeVest 5000 Patient Manual 1 - 8 Wireless interference The LifeVest can be susceptible to or cause wireless interference. Follow these instructions: • Cell phone use – When using a cell phone, keep it at least 10.6 inches (27 centimeters) away from the round electrodes on the electrode belt. If you experience noise alerts while using a cell phone, move the cell phone away from the electrode belt or stop using the cell phone. • Charger use – The charger contains a cellular device for data transmissions. Keep the charger at least 10.6 inches (27 centimeters) away from your body to prevent interference. If you experience noise alerts while using the charger, move away from the charger. If you take the charger to a hospital, be sure that the use of cellular devices is permitted. If not, do not use the charger while in the hospital. If you need to transmit data, use your in-home or supported open WiFi network. • General precaution – If you experience any interference with the LifeVest when in the presence of any other wireless device, move away from the device or stop using the other device. If you continue to have problems, call ZOLL. FCC regulatory information This device complies with part 15 of the FCC Rules. 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. The monitor contains FCC-ID: W56MTPCIE-BW-A. Refer to charger label for FCC ID. Changes or modifications to this device not authorized by ZOLL could void the RF compliance and negate your authority to operate the device. The available scientific evidence does not show that any health problems are associated with using low power wireless devices. There is no proof, however, that these low power wireless devices are absolutely safe. Low power Wireless devices emit low levels of radio frequency energy (RF) in the microwave range while being used. Whereas high levels of RF can produce health effects (by heating tissue), exposure of low-level RF that does not produce heating effects causes no known adverse health effects. Many studies of low-level RF exposures have not found any biological effects. Some studies have suggested that some biological effects might occur, but such findings have not been confirmed by additional research. The LV5000 has been tested and found to comply with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65. The maximum SAR levels tested for the LV5000 has been shown to be 0.133 W/kg at Body.
Meet the LifeVest 5000 System 2-1 2: Meet the LifeVest 5000 system Components Item Description Garment and electrode belt The garment fits around your body and the electrode belt connects to the monitor. The electrode belt contains the therapy pads, round electrodes and the vibration box. See details on page 2-2. Monitor Connects to the electrode belt. Monitors your heart rhythm and initiates a treatment. See details on page 2-3 and 2-4. A strap is attached to the monitor for easy mobility while wearing the device. Charger and battery Recharges the battery, communicates wirelessly with the monitor, and transmits data for prescriber review. The LifeVest system includes two batteries so that the monitor can run continuously on battery power. See details on page 2-8 and 2-9. 2 1 3
Meet the LifeVest 5000 System 2-3 Monitor — front view Item Description Response buttons Two buttons, located on the front and back of the monitor, that light solid red when the device senses that your heart has a life threatening, irregular rhythm. If you are conscious, press both response buttons to stop the LifeVest from delivering a treatment. You can press and release the response buttons; you don’t have to hold them continuously. Speaker Audible voice prompts and alerts. Status indicator lights Indicate system status. Green: On solid during normal operation. Off during gong or siren alerts. Yellow: Flashes during a gong alert to tell you that something requires your attention. Check monitor screen for any instructions. Connector Connection site for the electrode belt cable. Strap attachment Two strap attachment areas on either side of the monitor. The strap is adjustable to give you two options to comfortably wear the system. For options on how to wear, see section 3. Touchscreen Displays messages about device operation, and allows you to interact by touch with the device. When the monitor is held upside down, the display flips so that you can read the screen. Most of the time during normal monitoring, the touchscreen is dark. To view the display on the screen, press the response buttons. For details, see page 2-5. 1 2 3 4 6 5
LifeVest 5000 Patient Manual 2 - 4 Monitor — back view Item Description Battery placement area Location of battery placement in the monitor. Battery Powers the monitor. To recharge the battery, use the charger; see page 2-8. Battery release button Press to remove the battery from the monitor. 1 2 3
Meet the LifeVest 5000 System 2-5 Monitor touchscreen Shown on the following page is an example of the monitor screen during normal monitoring. Not all of the symbols, controls, and indicators shown in this example will appear all of the time. Some symbols are shown only at certain times. As situations change, the screen will change to advise you and suggest an action to take. Screens that require you to take some action will have a help screen associated with them. For more on help screens, see page 2-7. Most of the time the monitor display screen is darkened to conserve battery power. If you wish to view the Home screen or complete an action while wearing the LifeVest, press the response buttons. For a complete description of how to use the touchscreen in the daily use of the LifeVest, see section 3.
LifeVest 5000 Patient Manual 2 - 6 Item Description Patient name Displays your name so you know this device was programmed for you. Menu button Tap to display the Patient Menu, where you can select various options. See details in section 3. Electrode belt status Round electrodes are connected to the patient and are in normal monitoring mode. Belt is not connect ed. See details in section 5. Battery status Shows amount of charge remaining in battery. Green displays the remaining charge level. Yellow indicates that the battery needs to be changed. Call ZOLL for a replacement. Red indicates a depleted charge. Airplane mode Airplane mode is on. For details, see section 3. Recording heart rhythm Indicates that your heart rhythm is being recorded for your prescriber to revi ew, see section 3.
Meet the LifeVest 5000 System 2-7 Help screens For any screen on the monitor that has a question mark icon in the lower right corner, you can tap that icon and see a help screen. Shown below is an example of a help screen. Note: Not all screens will have a help button. This button also appears in different colors such as on response button screens where the help button is blue . Item Description Help message Brief message telling you what to do based on the present condition. Touch to speak If the speak option is enabled, touch the message area of the screen to hear the help message. The message will be spoken in the language displayed. The area to tap is shown by the dashed line in the example above; the dashed line will not be visible on screen. To enable this feature, see section 3. X button Tap to close the screen. Translation button O nly appears if more than one language is programmed.
LifeVest 5000 Patient Manual 2 - 8 Charger The charger recharges the battery and communicates wirelessly with the monitor. The LifeVest system includes two batteries so that the monitor can run continuously on battery power. For details on battery care, see section 3. Item Description Power supply Plugs into a standard power outlet to provide power to the charger. For the charger power supply, any 60601-1 or 60950-1 approved power supply providing an output of 18 VDC at 1.67 Amps (min) with a CUI PPM-2-35135-SG connector, see Charger setup in section 3 for details . Battery status indicators Indicate charger status. See details on page 2-9. Battery Powers the monitor. To recharge the battery, use the charger. Power supply connection area Connects the power supply to the charger. 1 2 3 4
Meet the LifeVest 5000 System 2-9 Battery charger indicators The battery charger indicators are located on the top of the charger. These indicate the charger status. For details, see section 3. Icon Description Power Charger is connected to a power source. Charging Battery is currently being charged. Light blinks until fully charged and then turns off. Charge complete Battery has full power. Battery fault Charger communication may not be functioning properly. Charger can still be used to charge battery. Solid light and a momentary beeping sound occurs. Call ZOLL. Charger fault Problem with the charger. Light blinks and a beeping sound occurs. Call ZOLL. 2 1 3 4 5
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Using the LifeVest 5000 System 3 - 1 3: Using the LifeVest Daily routine This is an overview of the steps involved in the daily use of the LifeVest. Some details are found elsewhere in this manual. 1. Wear the assembled electrode belt and garment. For details on wearing the LifeVest, see section 4. 2. Put a fully-charged battery into the monitor and follow the normal startup routine. See page 3-2. 3. Change and recharge the battery every 24 hours. See page 3-3, Battery care. 4. Wear the monitor with the strap fastened to the two attachment areas on the monitor. The strap is adjustable to give you two options to comfortably wear the system, either around your waist or hanging over your shoulder like a purse. 5. Respond to any alerts. See section 5. 6. Remove the battery from the monitor and then completely remove the LifeVest from your body when you shower or bathe. Do not reinsert the battery until you are wearing the fully assembled device. See section 4. 7. Change and wash the garment every 1 or 2 days. Wash only the garment. Do not wash the electrode belt, monitor, or any other accessories. Follow the instructions in section 4 for laundering the garment.
LifeVest 5000 Patient Manual 3 - 2 Normal startup routine 1. Remove the depleted battery from the monitor. 2. Insert a fully-charged battery into the monitor. • Make sure the battery is completely inserted. 3. Startup screen appears. 4. When you hear the gong and feel the vibration on your back, press the response buttons. • If you do not hear the gong or feel the vibration within 30 seconds, remove the battery. Reinsert the battery and try again. • If the monitor still does not operate normally, contact ZOLL. 5. The monitor displays your name and battery level. • Make sure your name appears on the monitor. If your name does not appear, contact ZOLL immediately. 6. During normal monitoring, most of the time the LifeVest monitor screen displays a dark screen and the green status indicator is lit solid. • To see the display, press the response buttons.
Using the LifeVest 5000 System 3 - 3 Battery care What you need to know • You have two batteries, so you can use one while charging the other. • Change and recharge batteries every 24 hours. • Recharging the battery takes approximately 4 to 6 hours. • Place the charger in a safe place where you can leave it plugged in. Keep the second battery in the charger while you use the monitor. • Always have a battery in the charger, even when fully cha rged. • The battery and charger may get warm. This is normal. Place the charger in a well ventilated place. • Use only the batteries and charger supplied with the LifeVest system. • Remove the battery from the monitor when not wearing the device (when showering, for example). Always remove the battery first to ensure the device is not active when you are not wearing it. A “whistle” alert will sound if the battery has been left in the monitor for over 20 minutes with the electrode belt disconnected. In the event of a power outage If there is a power interruption you need to take steps to keep your batteries charged. • Notify your electric company that you have a medical device that needs power. If they believe the power will be out for 24 hours or more seek alternatives for powering the batteries, such as a neighbor or family member not affected by the outage. • Notify your local emergency medical services and see if they can help. • Locate a source of backup power if possible, such as a generator. Plug the battery charger into the backup power and charge the spare battery continuously. Change the batteries every 24 hours. If help is not available, and you expect power to be out for more than 24 hours, contact ZOLL immediately to have spare batteries sent to you. When the power is restored, continue charging and changing batteries every 24 hours.
LifeVest 5000 Patient Manual 3 - 4 Charger setup If the charger or power supply makes unusual noises, sparking, starts to smoke, or emits a burning smell, unplug it immediately from the wall outlet. The only way to completely remove power is by unplugging the AC power plug from the wall outlet. Note: For the charger power supply, any 60601-1 or 60950-1 approved power supply providing an output of 18 VDC at 1.67 Amps (min) with a CUI PPM-2-35135-SG connector as detailed below may be used. Connection Designation Inner Contact + V Outer Ring - V 1. Place the charger in the room where you sleep, on a nightstand or end table, near a power outlet. • Place the charger so you can easily get to the top of the unit to insert and remove the battery. • The charger can actually be placed anywhere in the house, but we recommend the room where you sleep so it is convenient to use every day. 2. Plug the power supply into the back of the charger, then plug it into a standard power outlet. • Make sure the outlet stays on all the time, and is not controlled by a light switch. • Keep the charger plugged in at all times. • When you first plugin the charger, all of the icons will blink three times and you will hear a rapid, beeping sound. • When the charger is powered on, the blue icon remains on .
Using the LifeVest 5000 System 3 - 5 3. Gently insert the spare battery into the charger. • Orient the battery with its connector facing into the base of the charger. • Push the battery in firmly. • It takes approximately 4 to 6 hours to charge a battery. • Keep a battery in the charger at all times, even when fully charged. 4. Look for a symbol along the left of the charger’s display. These symbols indicate the battery status. • The battery should be charged or charging. • These symbols are explained in the next section, Charger and battery status indicators.
LifeVest 5000 Patient Manual 3 - 6 Charger and battery status indicators Icon What it means What to do 1 Power Power is on. Plug the power supply into the back of the charger, then plug it into a standard power outlet. Make sure the outlet stays on all the time, and is not controlled by a light switch. Always leave a battery in the charger, even when the battery is fully charged. 2 Charging Battery is charging. Let the battery charge. This can take 4 to hours. 6 3 Charge complete Battery is fully charged, ready for use in monitor. Leave battery in the charger until ready to exchange battery even when the battery is fully charged. 4 Battery fault Battery has a problem. Call ZOLL for a replacement battery. 5 Charger fault Charger has a problem, and cannot charge the battery. Do not leave a battery in the charger. Battery is not being charged. Call ZOLL for a replacement charger.
Using the LifeVest 5000 System 3 - 7 Change and charge batteries daily Leave the electrode belt connected during this procedure. 1. Remove the existing battery from the monitor by pressing the release button on top of the battery, moving it away from the monitor. • Leave the electrode belt connected to the monitor during this procedure. 2. Remove the fully-charged battery from the charger and place it into the monitor. • Push the battery firmly into the monitor until it clicks to ensure it is fully inserted. 3. Gently place the used battery from the monitor into the battery charger. • Properly orient the battery with the label side down and firmly push it into the charger base. • Check the battery status on the charger and verify that the battery is being charged. It takes approximately 4 to 6 hours to charge a battery.
LifeVest 5000 Patient Manual 3 - 8 Record your heart rhythm (ECG) At times, you may want to record your heart rhythm ( ECG) for your prescriber to review. 1. Hold the response buttons for 3 seconds. 2. Release response buttons when you see the recording indicator and hear a single gong. On the monitor the ECG recording indicator will appear in the bottom right corner of the screen. The recording will take 15 seconds.
Using the LifeVest 5000 System 3 - 9 Patient menu screen Tap MENU on the Home screen to open the Patient Menu screen. Note: Your prescriber may assign ACTIVITIES for you to perform. If the ACTIVITIES icon is not displayed on your monitor your prescriber has not assigned you to do any. Settings menu See more information starting on page 3-10. Send data See more information in on page 3-11. Activities menu See more information in section 6, Using the activities options. Note: If the ACTIVITIES icon is not displayed on your monitor it is inactive. It is not necessary to have ACTIVITIES activated. This is at your prescriber’s discretion.
LifeVest 5000 Patient Manual 3 - 10 Voice options The LifeVest system provides the option of having Help screen messages spoken to you when they are displayed on the monitor. Help screens provide information and/or instructions about a specific topic or aid in resolving a problem. This section explains the voice options and how to set them so the monitor speaks Help messages. Note: Voice options do not affect the volume level of physiological alerts or messages. 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap VOICE . 4. On Help Voice Options there are two options: Volume and Mode. Volume Use the arrow keys to increase or decrease the volume of the messages. Note: Volume is not affected for physiological al ert s or mess ages. Mode If you want the messages to automatically speak to you when Help screens appear, select the Always Speak option. If you want the messages spoken to you only when you tap the screen when Help screens appear, select the Tap to Speak option. If you do not want to hear the messages spoken to you, select Mute. 5. Tap ACCEPT to confirm your selections and return to the Settings screen. To close the screen without making any changes, tap X .
Using the LifeVest 5000 System 3 - 11 Sending data manually Normally, data transmission from the monitor to ZOLL occurs without you having to initiate it. However, if data is requested by ZOLL after a treatment or for another reason, the Send Data icon provides the means for you to send the data. 1. On the monitor home screen, tap MENU . • If the monitor screen is off, press the response buttons to show the home screen. 2. On the Patient Menu, tap SEND DATA . 3. Tap SEND to begin the data transfer. Note: Look at the WiFi and cell signal strength icons for network availability. See details on page A-1. If you experience problems sending data, call ZOLL. 4. The device then connects through the charger or through WiFi to send your data. • The gray envelopes on the screen will turn green as data is successfully sent to ZOLL.
LifeVest 5000 Patient Manual 3 - 12 5. Your download is complete once you see all envelopes turn green and hear a gong alert. 6. Tap ACCEPT to close the Send Data screens and go to the Home screen. 7. You have now successfully sent your data to ZOLL. If data is unable to send, you will see this screen and hear a gong alert. Tap TRY AGAIN . If you continue to have a problem sending data, write down the service code (in the bottom right corner of the screen) and call ZOLL. If airplane mode is ON you will see this screen. Tap CONTINUE to turn airplane mode off and continue sending data. For details, see Airplane mode page 3-13.
Using the LifeVest 5000 System 3 - 13 Airplane mode Airplane mode disables transmitting data capabilities. Use Airplane mode in any situation where wireless transmission use is prohibited in order to avoid interference with aircraft operation and other electrical equipment. 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap AIRPLANE . 4. Airplane mode is off by default. Tap ON to enable Airplane mode, then tap ACCEPT to confirm and close the screen. Note: The monitor will go out of airplane mode the next time you remove or change the battery. Tap X to close the screen without making any changes .
LifeVest 5000 Patient Manual 3 - 14 5. The airplane symbol will appear and remain on the Home screen when airplane mode is enabled. Note: The monitor will go out of airplane mode the next time you change the battery. If you attempt to manually send data, enter support mode, or set up a WiFi connection while in airplane mode, you will see this screen: You have two choices: 1. To turn off airplane mode and continue with the task, tap CONTINUE . 2. To leave airplane mode turned on and not proceed with the task, tap X .
Using the LifeVest 5000 System 3 - 15 WiFi WiFi allows you to transmit data to ZOLL from any location where wireless networks are available. Searching for and accessing available WiFi networks 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap WiFi . 4. On WiFi Settings, tap SEARCH AVAILABLE NETWORKS to browse for an available WiFi network. Note: If airplane mode is off and no downloads are taking place, the WiFi Settings screen displays. A searching message will appear while the device looks for an available network.
LifeVest 5000 Patient Manual 3 - 16 5. If networks are available they will appear for selection. Use the up and down arrows to navigate to additional networks in the list. Each network displays signal strength and security status (locked or unlocked). A locked network is a closed network that is not accessible by the LifeVest. 6. Tap on the network name you want to use. A wait screen may appear while your selection is identified. Tap X at any time to cancel. Encrypted Network Password required: If a password is required when you select a network, a keyboard appears for entering the password for that network. Tap the shift key (up arrow) on the keypad to shift between uppercase and lowercase letters. Tap the numeric button to access numbers and symbols. Tap the cancel/backspace key to delete and retype the password. After typing the password, tap ACCEPT . A wait screen may appear while your password is being validated.
Using the LifeVest 5000 System 3 - 17 7. If the network is available, its name is displayed as connected. Tap ACCEPT . Password invalid: A screen is displayed If the password is invalid. Tap TRY AGAIN and re-enter the password on the keypad screen. Tap X to close. A screen displays to inform you if the network is not available. If this occurs, tap ACCEPT to go back to the Search Available Networks menu to choose a new network. If Previously Connected: If the device was previously connected to the WiFi network selected then the WiFi network information screen will appear. Tap CONNECT to proceed to the Enter Password screen. Tap FORGET for your device to forget all information for this WiFi network. To close the screen without making any changes, tap X .
LifeVest 5000 Patient Manual 3 - 18 Tapping FORGET on the previous screen displays the WiFi Network information screen . Tapping FORGET a second time deletes all network information on this device. To go back to the WiFi Network security scre en, tap X . If no networks are available, the “No WiFi networks are available” message is displayed. Tap ACCEPT to go back to the WiFi Settings menu. If you do not tap ACCEPT , after 30 seconds a timed out screen will display. If you are already connected to a WiFi network or have previously connected you will bypass the password screens and go directly into th is screen. Network Connected: If you are connected to a network DISCONNECT appears on the WiFi Network screen. Tap DISCONNECT to get back to the WiFi settings menu. Tap FORGET to go to the WiFi Network Forget screen. To go back to the WiFi Settings screen, tap X .
Using the LifeVest 5000 System 3 - 19 If you are not able to connect to WiFi Settings one of the next two screens will display. If a download is in progress, this screen displays. If airplane mode is on, this screen displays. Tapping CONTINUE turns off airplane mode. Tap X to close this screen and remain in airplane mode. For details, see Airplane mode on page 3-13.
LifeVest 5000 Patient Manual 3 - 20 Entering a hidden WiFi network 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap WiFi . 4. On the WiFi Settings menu, tap ENTER HIDDEN NETWORK . If ENTER HIDDEN NETWORK is selected from the WiFi Settings screen, a keypad screen appears to enable entry of the network name. 5. After typing in a Network Name, tap ACCEPT . 6. If a Network is available , the Network Security screen appears, displaying security level options. If you are not sure of your network security, select WPA2 as your first option. A “Please wait…” screen may then appear while your selected network option is being connected. If you require assistance with the hidden network connection, contact ZOLL. 7. If a Password is required wh en you select a network from the list, a keyboard appears. After typing the password, tap ACCEPT . If you do not tap ACCEPT , after 30 seconds a timed out screen displays.
Using the LifeVest 5000 System 3 - 21 If NO password is required , the connection is made. Tap ACCEPT to continue. If the network is not available , a screen is displayed to inform you of this. Tap TRY AGAIN to try and connect to the network again. This takes you back to the Enter Network Name keypad screen. Tap X to close. This takes you back to the Enter Network Name keypad screen. Try connecting with the WPA security network option. If you are still unable to connect, contact ZOLL for assistance.
LifeVest 5000 Patient Manual 3 - 22 Clearing all saved WiFi networks 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap WiFi . 4. On the WiFi Settings menu, tap CLEAR ALL SAVED NETWORKS . 5. On the CLEAR ALL SAVED NETWORKS screen, tap DELETE to delete all saved WiFi networks or CANCEL to go back. 6. Tap DELETE to confirm deleting all saved WiFi networks. Tap CANCEL to go back to the WiFi Settings menu. 7. The last screen provides confirmation that all WiFi networks have been deleted. Tap ACCEPT to take you to the WiFi Settings menu screen.
Using the LifeVest 5000 System 3 - 23 System information If you ever call ZOLL, you may be asked for information about your LifeVest. You may be instructed to go into the system information screens. 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap INFO . 4. The System Information screens display information associated with the system components. Tap on the right arrow to see more System Information options. Tap X to close and return to the Settings Menu.
LifeVest 5000 Patient Manual 3 - 24 Support mode This feature lets ZOLL update the settings in your LifeVest monitor while you remain at home. It is a simple process that should take just a few minutes. Updating your LifeVest: • ZOLL will call you to talk you through the updating process. • Remain on the phone with ZOLL until this entire process has been completed. • Continue to wear the device during this process. • You will interact with the monitor screen, tapping icons and reading back what the display says. • If you are unable or uncomfortable doing this, have someone with you who can talk with ZOLL and interact with the monitor.  • Follow along with the procedure below. Note: You need to have access to your charger or WiFi to update your settings. ZOLL will call you to assist you through this process. 1. On the home screen, tap MENU . 2. On the Patient Menu, tap SETTINGS . 3. On the Settings Menu, tap SUPPORT . 4. On the Support Mode screen, tap CONTINUE . 5. A “Connecting” screen appears.
Using the LifeVest 5000 System 3 - 25 6. When this screen appears, read this number to the ZOLL representative. 7. A “Please wait…” screen appears. 8. Read this number to the ZOLL representative. 9. Tap ACCEPT . Note: If you attempt to enter the support mode while in airplane mode, you will see this screen. You have two choices: • To turn off airplane mode and continue to enter support mode, tap CONTINUE . • To leave airplane mode turned on and not enter support mode, tap X and return to the Settings Menu screen. For information on Airplane mode, see page 3-13.
LifeVest 5000 Patient Manual 3 - 26 Periodically clean and inspect the system WARNING Do not put the monitor, electrode belt, battery or charger in or near water. Water entering the device may damage it and/or cause the system to malfunction. If you see Blue™ gel other than during a treatment, this may indicate a damaged electrode belt and cause the system to malfunction. Call ZOLL LifeVest immediately. Clean the electrode belt and inspect equipment when changing garments. Specific details about laundering the garment are in section 4. Cleaning non-washable items Unplug the battery charger and disconnect the power cord from the wall outlet before cleaning. If necessary non-washable items such as the charger, batteries, cables, and therapy pads may be cleaned with a soft cloth. Do not use a damp cloth or anything with water, chemicals or cleaning solutions. If necessary, clean the monitor touchscreen by wiping it with a soft cloth dampened with window or glass cleaner. Dampen the cloth directly, do not spray anything directly on the monitor. The round electrode metallic surface may be cleaned with a soft cloth dampened with rubbing alcohol. • Don’t apply liquids directly to any of the non-washable items, as they contain electronic components that can be damaged. • Don’t attempt to clean any electrical contacts or connectors. • Do not use any cleaning solution on the garment. Specific details about laundering the garment are in section 4. Call ZOLL if any additional cleaning is needed for the monitor or charger. Inspection Inspect your system when changing garments. If you should notice any of the following conditions, please notify ZOLL as soon as possible: • Cracks in the housing of the monitor, battery, or charger. • Cracks or lines showing on the monitor screen. • Cracks in the therapy pads. • Tears in the garment. • Blue™ gel leaking from the therapy pads at any time other than when defibrillation is about to occur or has just occurred.
Using the LifeVest 5000 System 3 - 27 What family members need to know WARNINGS Only the patient should press the response buttons. The patient’s ability to press the response buttons lets the device know whether or not the patient is conscious and is critical in deciding when to give the patient a treatment. If anyone other than the patient presses the response buttons, needed therapy may not be delivered, possibly resulting in serious injury or death. Do not touch the patient while a treatment is being delivered. Anyone touching the patient during a treatment may be shocked. Do not remove the battery, do not disconnect the electrode belt from the monitor, and do not loosen the garment while the monitor is broadcasting alert sounds and/or voice prompts. If the battery is removed, the electrode belt disconnected from the monitor, or the garment is loosened, needed therapy may not be delivered, possibly resulting in serious injury or death. CPR can be performed as long as the monitor is not broadcasting alert sounds and/or voice prompts. If external defibrillation is available, a decision can be made by a medical professional to remove the device and monitor/treat the patient with external equi pment. Information for family members Since your family member or friend may be wearing the LifeVest device for a period of time, you may want to understand the daily routine involving the device, as well as warnings and cautions directed to the patient. In that case you should read this entire manual. Anyone associated with the patient should be aware of the following information: The LifeVest directs a conscious patient to respond to messages and alerts. A patient who has lost consciousness due to their arrhythmia will be unable to respond, letting the device know it is time to deliver a treatment. The bystander should not respond to messages and alerts in place of the patient. • If the LifeVest treatment does not revive the patient and the patient is unconscious, call for help and then start CPR. • If the patient remains conscious, check the belt to make sure all round electrodes are pressing against the patient’s skin. • A label on the front of the garment reminds medical professionals to open the garment before giving the patient conventional external defibrillation. • Keep the LifeVest device out of the reach of children. *1 *1 See indication for patients under 18 years of age.
LifeVest 5000 Patient Manual 3 - 28 When you are finished with the device Call ZOLL and arrange to return the LifeVest system. Battery recycling WARNING Do not dispose of or incinerate the batteries. The batteries contain lithium ion and must be disposed of properly by ZOLL. The lithium-ion batteries used with the LifeVest device are recyclable and should be returned to ZOLL.
Assembling and putting on the garment 4 - 1 4: Garment and electrode belt Assemble the garment and electrode belt Lay the electrode belt and garment on a flat surface as shown in the illustration. • Place the garment with the silver mesh fabric facing up. • Place the electrode belt with the silver sides of the therapy pads facing up. 1. Insert the rear therapy pads into the garment’s rear pockets. • The rear pockets are numbered 1. • Insert the pads silver to silver, meaning place the silver sides of the pads (with the green labels) facing the silver mesh fabric on the pockets. Make sure the pads are flat against the silver mesh fabric. • Snap the green tabs to close the pockets, making sure they are securely fastened.
LifeVest 5000 Patient Manual 4 - 2 2. Position and secure the vibration box to the garment. • The vibration box flap is numbered 2 on the garment. • Place the vibration box with the label side facing up. • Make sure wires are not crossed or twisted. • Snap the flap over the vibration box to the blue tabs, making sure all three snaps are securely fastened. 3. Insert the front therapy pad into the front pocket. • The front pocket on the garment is numbered 3. • Insert the pad with silver to silver, meaning place the silver side of the pad (with the green labels) facing the silver mesh fabric on the pocket. • After the therapy pad is fully inserted, snap the pocket closed, making sure it is fastened securely.
Assembling and putting on the garment 4 - 3 4. Attach the round electrodes to the garment, matching the colors on the backs of the round electrodes to the colors of the Velcro on the garment. Make sure not to cross or twist the wires. 5. Make sure that you have properly assembled the electrode belt to the garment. Assembled garment and electrode belt The assembled electrode belt and garment should look like the following figures. Outside view This side faces away from your body when worn. The foam sides of the therapy pads face the back of the garment. Inside view This side is placed against your body when worn. The silver mesh fabric pockets are against your skin. The green labels are visible through the silver mesh fabric.
LifeVest 5000 Patient Manual 4 - 4 Putting on the assembled garment and electrode belt Follow these instructions to put on the assembled garment, then make sure you’re wearing it properly. 1. Before putting on the garment, remove all clothing and undergarments from your upper body. • All clothing, including underwear must be worn OVER the device, NOT under it. 2. If desired, apply unscented hand lotion to the four round electrodes. 3. Put on the garment, making sure: • The garment doesn’t get twisted. • The silver mesh fabric pockets touch your bare skin. • The round electrodes are flat against the skin with no crossed or twisted wires. If you are a female: • Wear a bra OVER the assembled electrode belt and garment. • Make sure that the silver side of the front therapy pad is pressing against your body underneath your lef t breast.
Assembling and putting on the garment 4 - 5 4. Connect the garment ends together in the front. • Make sure that the clips are fully inserted past the slight bumps in the clips. • There are two clip sets, a looser and tighter setting allowing for fitting adjustments. 5. Look in a mirror to make sure that: • The garment is being worn correctly, fitting snug to your torso. • The garment is not twisted. Straps are flat against your skin and tightened. • The round electrodes and therapy pads are pressing against bare skin. The silver mesh fabric pockets and silver side of the therapy pads (with green labels) MUST TOUCH YOUR BODY for the device to work properly. • None of the cables are crossed, twisted together or interfering with the round electrodes. Your garment should look like these figures.
LifeVest 5000 Patient Manual 4 - 6 6. Check the position of the garment on your body and make sure it is not too high or too low. To position the garment properly, you may need to adjust the shoulder straps. Move the buckle sliders to position the garment properly, and for a snug fit. • The garment should cross your body just below your breastbone. • The garment should not be as high as your nipples. • The garment should not be as low as your belly button.
Assembling and putting on the garment 4 - 7 Connecting and disconnecting the electrode belt WARNING Do not force the connector. Allow the connector to align before pushing it in. Forcing the connector may damage it and cause the system to malfunction. To connect the belt Line up the connector with the monitor. The cable should face toward the center of the monitor. Gently push the connector straight in until it locks in place. To disconnect the belt Gently squeeze the sides of the connector as you pull it straight out of the monitor.
LifeVest 5000 Patient Manual 4 - 8 Remove when showering and bathing WARNING Do not put the monitor, electrode belt, battery or charger in or near water. Water entering the device may damage it and/or cause the system to malfunction. Always completely remove the LifeVest device when you shower or bathe. Don’t put the monitor, electrode belt, or battery in or near water. When you remove the device for any reason, remove the battery first. When you remove the LifeVest to bathe or shower, you are not protected by the device. Bathe or shower preferably when someone else is home with you. When you put the LifeVest back on, put the battery in last. Note: The battery should be removed if the LifeVest is not being used. A loud whistle sound is activated if the LifeVest has been idle for 20 minutes or more with the electrode belt disconnected. This alerts you to remove the battery. Removing the LifeVest device before you bathe or shower 1. Remove the battery from the monitor. Keep the belt connected to the monitor. 2. Unfasten and remove the garment from your body. To change the garment, follow the procedure on page 4-9 and then 4-1.
Assembling and putting on the garment 4 - 9 Disassembling the garment and electrode belt 1. Remove the four round electrodes from the garment by gently separating the Velcro from the garment. Do not pull on the wires. 2. Unsnap fasteners and remove the vibration box from the garment. • Gently pull vibration box away from the garment. Pulling on the vibration box wires can damage the internal wiring and cause the system to malfunction. 3. Unsnap and remove the therapy pads from their pockets. 4. Wipe the metallic surfaces of the round electrodes with a soft cloth dampened with rubbing alcohol. Note for reference: • Assembling the garment and electrode belt see page 4-1. • Putting on the assembled garment and electrode belt see page 4-4. • For laundering instructions, see page 4-10.
LifeVest 5000 Patient Manual 4 - 10 Laundering the garment WARNING Do not use chlorine bleach, bleach alternatives, fabric softener, anti-static sprays or detergents that include bleach or fabric softener additives when laundering the garment. Using bleach or any of these other prohibited agents to launder the garment may damage it and cause the system to malfunction. Launder the garment every 1 or 2 days. Before washing the garment: • Remove the electrode belt (round electrodes and therapy pads) to protect it from damage. Do not wash the electrode belt with the garment. • Attach the clips of the garment together. • Wash the garment by itself. Do not wash it with other laundry. • The garment may be hand-washed or machine washed, using a normal wash cycle and warm water, with a maximum water temperature of 45°C (113°F). • Use a mild clothes washing detergent only, such as varieties for sensitive skin. • Use a clothes dryer on medium heat setting to dry the garment. Do not use the high heat setting. Do not use dryer sheets. (If a dryer is not available, the garment may be laid out on a flat surface to air dry.)
Responding to alerts 5 - 1 5: Responding to alerts Overview of alerts This section is organized by the types of alerts you can experience while wearing the LifeVest: • Physiological alerts , such as in response to a treatment or asystole. See below. • Technical alerts such as a service code. See page 5-4. • Informative alerts , such as a reminder to change the battery or respond to round electrode noise. See page 5-6. Physiological alerts: vibration or siren sound These alerts are in response to a physiological condition or possible heart related activity detected while wearing the LifeVest. Vibration alert During normal use, if you get a vibration in the back of the electrode belt, you are being warned that the siren alert will sound within 5 seconds. You will also get a short vibration alert every time you change the battery. Press the response buttons to stop the siren alert and the vibration alert. Siren alerts The siren alert is a high-pitched two-tone sound that means an abnormal heart rhythm has been detected. The response buttons will turn red during this alert. Press the response buttons to stop this alert. If you do not respond to this alert, you will probably receive a treatment within the next minute. The siren alert is accompanied by screen messages and voice prompts. There are two possible messages: 1. If the alert is accompanied by a “respond” message follow instructions on the following page. This alert instructs you to respond. 2. If this alert is accompanied by the “call for help” message it will audibly instruct bystanders to call for help.
LifeVest 5000 Patient Manual 5 - 2 Responding to a siren alert WARNINGS If you get an alert sound and you are awake, always press the response buttons to prevent receiving a treatment. If you fail to press the response buttons, you will get a treatment. If you receive a treatment while your heart is beating normally and you did not use the response buttons, the treatment may cause an abnormal rhythm to occur. There is a small possibility that the abnormal heart rhythm may not be detected and death may result. If you are conscious , press the response buttons to stop the treatment from occurring. You will see these red bordered screens when you need to respond to a siren alert. • The siren stops and a voice prompt indicates that the treatment is being delayed. • NO ONE ELSE should press the response buttons. Only you, the patient, should press the response buttons. • If you feel dizzy, find a place to sit or lie down. • Press the response buttons each time you feel the vibration alert or hear the siren alert. If you are not conscious , you will not be able to press the response buttons. This allows the device to deliver a treatment. Voice prompts alert bystanders not to touch you. Voice prompts also alert bystanders to call for help after you have been given a treatment and remain unconscious.
Responding to alerts 5 - 3 If you receive a treatment After receiving a treatment, your back, sides and chest may feel wet. This wet feeling is the Blue™ gel that was released just before the first treatment was delivered. You might also have some chest soreness. When any of the following messages appear, tap Help for additional information about what to do. 1. Call your prescriber’s emergency number immediately to report your treatment. 2. Unless your prescriber tells you otherwise , continue to wear the LifeVest system. • Leave the belt connected. Do not remove the electrode belt or garment, and do not disconnect the electrode belt from the monitor. • Leave the battery in the monitor. Do not remove the battery. Continue to change and recharge the batteries as normal. • Leave the Blue™ gel under the therapy pads. Do not wipe them dry. • Tap ACCEPT after reading the message. 3. Call ZOLL and arrange to get a new belt. Tap ACCEPT to acknowledge you have read the “Call ZOLL” message on the screen. 4. Check for any further instructions that may be displayed for you to follow. For additional information, tap Help. For more details, see page 5-19.
LifeVest 5000 Patient Manual 5 - 4 Siren with call for help message If you are awake and feel fine and the monitor shows this message: • Press the response buttons to stop the message and siren alert. • If the alert continues even after you press the response buttons, remove and replace the battery to reset the device. • If you continue to get this message, call ZOLL. If you are not conscious , naturally you will not be able to press the response buttons. Voice prompts and messages alert bystanders to call for help.
Responding to alerts 5 - 5 Technical alerts: gong sound These alerts may indicate a problem with the device. Technical alerts are accompanied by a low-pitched “gong” sound that repeats about once a second. Note: This is the same gong sound that sounds for informative alerts, see page 5-6. If you get a technical alert, there is a problem that needs your attention. Take the following action: • Read the message on the monitor’s display. • Use the technical alerts list below to see what the message means and what to do. Message or i con on monitor What it means What to do System has a problem that requires servicing. The device is still able to be used. Continue using the device. Find the code number Example: 101) shown on ( the bottom left side of the monitor. Write down the code number and call ZOLL. Tap ACCEPT to return to Home screen. System has a more severe service problem. You CANNOT use the device. Call ZOLL immediately. Find the code number ( Example: 202) shown on the bottom left side of the monitor. Write down the code number and call ZOLL.
LifeVest 5000 Patient Manual 5 - 6 Informative alerts: gong or high-pitched “train whistle” sound These alerts are for informational purposes. Informative alerts are accompanied by either a low-pitched “gong” sound that repeats about once a second, or a high-pitched “train whistle” type of sound. If you get an informative alert there is a problem that needs your attention. Take the following action: • Read the message on the monitor’s display. • For specific help with any message, tap Help if it is available on the screen. • Use the following lists to see what the message means and what to do. Informative general gong alerts The following screens occur along with a gong alert during general functioning of the device. These alerts may occur at the startup of the device after battery replacement. Message or i con on monitor What it means What to do Press the response buttons to test their function every time the battery is installed. At startup, press the response buttons as a reminder of what to do when a siren alert sounds. This message may appear at startup. You may be holding the response buttons instead of pressing and releasing them. Release the response buttons. If you are not holding the response buttons, the device may not be functioning properly. Call ZOLL.
Responding to alerts 5 - 7 Message or i con on monitor What it means What to do Electrode belt is not connected to the monitor. Monitor is receiving a poor signal or no signal from the electrode belt. Gently connect electrode belt to monitor. If belt is already connected: 1. Remove battery. 2. Disconnect and reconnect electrode belt. 3. Reinstall battery. Note: Until you connect the belt, the monitor will intermittently toggle between this alert screen and the Home screen. The system is performing maintenance on the belt. No action required. Wait while this screen is displayed, usually about seconds. 30 The monitor has not automatically sent data either after a treatment was delivered or after a routine specified length of time. Send data manually as soon as possible. For details, see page 3-11.
LifeVest 5000 Patient Manual 5 - 8 Message or i con on monitor What it means What to do A connectivity issue is preventing the monitor from sending data to ZOLL. Tap TRY AGAIN to attempt sending again or tap X to close and try again later. Find the code number Example: 405) shown on ( the bottom right side of the monitor. Write down the code number and call ZOLL. A connectivity issue is preventing the monitor from connecting to the chosen network. Tap ACCEPT to attempt connecting again. If the connection fails a second time, find the code number (Example: shown on the 601) bottom left side of the monitor. Write down the code number and call ZOLL.
Responding to alerts 5 - 9 Informative electrode belt gong alerts The following screens occur along with a gong alert when the device detects electrode belt problems. Messa ge or i con on monitor What it means What to do Monitor is not receiving a good signal from the round electrodes that are colored red on the screen. A voice prompt will tell you to check round electrodes. Adjust your garment and electrode belt so that each round electrode is touching your skin. Clean the round electrodes with alcohol and apply unscented hand lotion. The system is checking the round electrode placement and their contact with your skin. No action required. Wait while this screen is displayed, usually about 30 seconds. The therapy pads are not making contact with your skin. Make sure the therapy pads are inserted correctly, with the metal sides facing the silver mesh fabric on the pockets. Make sure the therapy pads and mesh pockets are pressing against your skin.
LifeVest 5000 Patient Manual 5 - 10 Messa ge or i con on monitor What it means What to do Monitor is not receiving a signal from the electrode belt. Adjust your garment and electrode belt so that each round electrode is touching your skin. Make sure nothing is covering the metal surfaces of the round electrodes. Put a dab of unscented hand lotion on the surface of each round electrode. The monitor is not receiving a good signal from the electrode belt. Make sure the electrode belt is connected to the monitor. Remove the battery from the monitor. Take off the garment and make sure nothing is covering the round electrodes or therapy pads. Put a dab of unscented hand lotion on the surface of each round electrode. Put the garment back on and reinsert the battery. If problems continue, call ZOLL. For details, see section 4.
Responding to alerts 5 - 11 Informative battery gong alerts The following screens occur along with a gong alert when the device detects possible battery problems. Message or i con on monitor What it means What to do Yellow battery: Battery charge level cannot be determined. Remove the battery and insert the fully charged battery from the charger into the monitor. Continue wearing the LifeVest. Call ZOLL for a replacement battery. Red battery: Battery needs to be changed. Replace with a fully- charged battery. Place discharged battery into the charger. Tap ACCEPT to return to Home screen. A gong sounds if the battery has been left in the monitor when not in use. If the LifeVest has been idle for 20 minutes or more with the electrode belt disconnected a “train whistle” alert occurs. Remove the battery when the LifeVest is not being used. If the LifeVest is being used, ensure the electrode belt is properly connected to the monitor. Call ZOLL if the alert persists.
LifeVest 5000 Patient Manual 5 - 12 Informative after treatment gong alerts The following screens occur along with a gong alert after you have experienced an abnormal heart rhythm and received a treatment. Message or i con on monitor What it means What to do This message may appear after detection. You may be pressing the response buttons and you are no longer having a treatable heart rhythm. Release the response buttons. If you are not pressing the response buttons, device may not be functioning properly. Call ZOLL. You have received a treatment. Continue to wear the LifeVest device. Call your prescriber’s emergency number immediately. Leave the electrode belt connected; change and recharge the battery as normal. Follow instructions about what to do after receiving a treatment, see page 5-3. Tap ACCEPT to return to the Home screen. You have received a treatment.
Responding to alerts 5 - 13 Message or i con on monitor What it means What to do Blue™ gel has been released and the gel is drying out. Add gel to the therapy pads. Call ZOLL to get a replacement electrode belt. Tap ACCEPT to return to normal operation. For details, see page 5-19. Too much gel is on your skin. Leave the Blue™ gel that is under the therapy pads, but wipe the gel from the skin that is not under the therapy pads. Tap ACCEPT to return to normal operation. For details, see page 5-20.
LifeVest 5000 Patient Manual 5 - 14 Informative gong alerts: additional instructions on what to do The following are expanded instructions on what to do when certain gong alerts occur. Electrode belt message This screen shows which round electrodes are causing problems. The symbols help you to determine the problem. You may get any combination of these symbols: Good signal: (Green) Situation normal, no action required. Poor signal: (Yellow) Could be muscle noise, electrical noise, weak signal, lost signal, or interference. Off skin: Red) Round electrode is not ( making good contact with skin. No signal is detected. If you get one or more of the yellow or red symbols, make sure: • The round electrodes indicated by the yellow or red symbols are touching your skin. • Nothing is between the round electrodes and your skin, such as clothing or one of the cables. • Garment and belt fit snugly, with the round electrodes pressing against your skin. • Round electrode cable is securely connected into the monitor. While you’re wearing the LifeVest, tap Help for reminders about what to do.
Responding to alerts 5 - 15 Check round electrodes message You may get this screen with this voice prompt: Check electrodes. The problem may be with the signal from the round electrodes. Follow this procedure to correct the problem. 1. Check your electrode belt and garment. Make sure: • All four round electrodes are touching your skin, not flipped over or pulled away from your skin. • Nothing is between the round electrodes and your skin, such as clothing or one of the cables. • Garment and belt fit snugly, with the round electrodes pressing against your skin. • Round electrode cable is securely connected into the monitor. 2. If you continue to get this message, call ZOLL.
LifeVest 5000 Patient Manual 5 - 16 Check belt message After you get a number of belt problem screens, you may get a remove belt and check assembly message. It means that the monitor is still not receiving a good signal from the electrode belt. If you get this message: 1. Remove the battery from the monitor. 2. Disconnect the electrode belt from the monitor. 3. Take off the garment and make sure that nothing is covering the metal surfaces of the round electrodes. 4. Check that the therapy pads are in the pockets with the silver side touching the silver mesh fabric. 5. Put a dab of unscented hand lotion on the surface of each round electrode (the round ones, not the therapy pads). 6. Put the garment on, making sure it fits snugly, and connect the electrode belt to the monitor. Put the battery back into the monitor. While you’re wearing the LifeVest, tap Help for reminders about what to do. 7. If problems continue, call ZOLL.
Responding to alerts 5 - 17 Replace belt message After you receive a treatment to correct an abnormal rhythm, you may see a message telling you to replace the belt. Continue to wear the belt until you get the replacement belt. The belt is still functional and can provide additional treatments if needed. When you receive the new belt, follow the instructions below to replace the belt. While you’re wearing the LifeVest, tap Help for reminders about what to do. Tap ACCEPT to return to the Home screen. To replace the electrode belt: 1. Remove the battery from the monitor. 2. Disconnect the electrode belt from the monitor. 3. Remove the electrode belt and garment from your body. 4. Disassemble the electrode belt from the garment, assemble the new electrode belt into a clean garment, and put on the assembled electrode belt and garment, see section 4. 5. Connect the electrode belt to the monitor. 6. Put the battery into the monitor and follow the normal startup routine.
LifeVest 5000 Patient Manual 5 - 18 Therapy pad message This screen shows when the therapy pads (the large rectangular ones) are causing problems by not making good contact with your skin. Remember that there are three therapy pads: one in front and two in back. Any one of them could be causing the problem, so be sure to check all three if you get a red symbol. The symbols help you to determine the problem: Therapy pad off skin: Metal side is not making good contact with skin. Check all three therapy pads, front and back. Therapy pad on skin: Situation normal, no action required. If you get red symbols, make sure: • Therapy pads and mesh pockets are pressing against your skin. • Therapy pads are inserted correctly into their pockets, with the metal sides (with the green stickers) facing the metal mesh. • Garment and belt fits snugly, with the metal mesh of the therapy pads pressing against your skin. • Make sure to properly launder the garment, see page 4-10. While you’re wearing the LifeVest, tap Help for reminders about what to do.
Responding to alerts 5 - 19 Add gel to therapy pads After you receive a treatment to correct an abnormal rhythm, you may see this message telling you to add gel. Follow the instructions below to add gel. While you’re wearing the LifeVest, tap Help for reminders about what to do. Tap ACCEPT to return to the Home screen. To add gel: 1. Locate the packets of gel you received with the LifeVest system. 2. Remove the battery from the monitor, then remove the electrode belt and garment from your body. 3. Add one-half packet of gel to all three therapy pads, directly onto the silver mesh material of each pocket. Apply to the rear pads and the front pad (but not to the round electrodes.) 4. Put on the electrode belt and garment, see section 4. 5. Put the battery into the monitor and follow the normal startup routine.
LifeVest 5000 Patient Manual 5 - 20 Too much gel on therapy pads After you add gel to the electrode belt, you may see this message telling you there is too much gel between the therapy pads. Follow the instructions below to remove the excess gel. While you’re wearing the LifeVest, tap Help for reminders about what to do. Tap ACCEPT to return to the Home screen. To remove excess gel: 1. Remove the battery from the monitor. 2. With the electrode belt and garment on your body, and using a towel or soft cloth, wipe your skin between the front and back therapy pads on the left side of your body. Be careful not to remove the gel under the therapy pads. 3. Reinstall the battery into the monitor.
Using the activities options 6 - 1 6: Using the activities options Introduction to activities Your prescriber can request two activity options that are programmed into the system while you are wearing the LifeVest. These options are the health survey and the WalkTest™. Before you perform either of these activities for the first time, read this section of the manual. If your prescriber did not request the health survey or WalkTest™, you will not be able to access these options. These activities allow you to provide some additional information to your prescriber. Your prescriber may then use that information to help evaluate your condition. For more about the health survey option see “Taking the health survey” section below. For more about the WalkTest™ option see “Taking the WalkTest™”, page 6-7.
LifeVest 5000 Patient Manual 6 - 2 Taking the health survey If you get the message “Please complete health survey” when you change the battery, you are to take the health survey. You have the option of taking the health survey now or later. The LifeVest stores your answers and, during your next download, sends the results to a secure website where your prescriber can choose to review the results. Your prescriber may have you repeat the health survey once a day or once a week. The LifeVest will remind you when you are scheduled to take the health survey. If you have any questions, please contact your prescriber. What do I have to do? You need to answer the health survey questions honestly. It is important that you wear the LifeVest the entire time that you are taking the health survey so that it can monitor and protect you. While taking the health survey, follow the on-screen directions. Why is it important that I do the health survey? It is very important that you indicate how you really feel when you answer the questions. Your prescriber may use the information from the health survey to help evaluate your condition.
Using the activities options 6 - 3 Taking the health survey now If the monitor displays the screen with the message “Please Complete Health Survey” when you change the battery, you are to take the health survey. Read through all the health survey steps in this manual before you answer the questions for the first time. There are many health related questions that your prescriber can include in the survey. The questions and answers shown in these instructions may not be the questions and answers you see on your monitor. If any alerts are displayed during the health survey, see section 5. 1. Tap NOW to start the health survey. Tap Help for details. 2. The message on the screen instructs you to use the arrow buttons to select your answers. Tap ACCEPT. Note: To cancel taking the health survey, tap X at any time.
LifeVest 5000 Patient Manual 6 - 4 3. Read the first question. 4. Use the arrow keys to scroll to the appropriate answer. 5. Tap ACCEPT to choose your answer and continue to the next question. The question shown here is just an example. Your screen may show a different question. Note: If you want to hear the question spoken to you, tap the screen in the question area. You can change the voice option so you hear each question screen as soon as it appears, without tapping the screen. You can also change the voice volume. For the details about changing the voice setting, see Voice options in section 3. 6. Repeat steps 3 - 5 for the remaining questions. 7. Upon completion of the health survey you will see this screen. 8. Tap ACCEPT .
Using the activities options 6 - 5 Taking the health survey later If you tap LATER , the system returns to the Home screen instead of proceeding with the health survey. When you decide to complete the health survey, access it by tapping MENU on the Home screen, then ACTIVITIES , and then HEALTH SURVEY .
LifeVest 5000 Patient Manual 6 - 6 Health survey messages As you take the health survey, you may get one of these messages. If so, here is what the message means and what you should do. If you get any other messages, see Section 5, Responding to alerts. Message What it means What t o do You are attempting to take the survey with the electrode belt disconnected. The belt needs to be connected to take the health survey. Wear the LifeVest and connect the electrode belt to the monitor. After connecting the electrode belt, the message goes away. Try again to take the health survey. You are attempting to take the health survey more frequently than scheduled. Tap ACCEPT to clear the message. Wait until you get this message: “Please complete health survey."
Using the activities options 6 - 7 Taking the WalkTest™ WARNINGS If you get the siren alert, stop walking and press the response buttons. When performing the WalkTest™, do not continue walking if the monitor broadcasts an alert sound stop walking and press the response buttons as you normally would. If you continue walking, you may place yourself at risk for a cardiac arrest, possibly resulting in serious injury or death. When performing the WalkTest™, do not continue walking if you experience symptoms such as shortness of breath, chest pain, or other pain or discomfort. Stop walking and sit or lie down. If the symptoms continue or get worse, immediately call your doctor or emergency help. If you continue walking or ignore the symptoms, you may place yourself at risk for a cardiac arrest or other health problems, possibly resulting in serious injury or death. Your physician prescriber may order the WalkTest™ as one of the ways to use the LifeVest to gather information about your condition. How does it work? The purpose of the WalkTest™ is to monitor your heart and count your steps while you walk for minutes. 6 Before and after the walk, you will be asked two questions: one about your shortness of breath level and another about your fatigue level (how tired you feel). After the walk, you will answer the same two questions again. Look at the screen for the possible answers and pick the one that most closely describes how you feel at that moment. During the next scheduled data download, the LifeVest sends your WalkTest™ information to a secure website where your physician prescriber can review the results. Your physician prescriber may have you repeat the WalkTest™ once a day or once a week. The LifeVest will remind you when you are scheduled to take the WalkTest™.
LifeVest 5000 Patient Manual 6 - 8 What do I have to do? It is important that you wear the LifeVest the entire time that you’re doing the WalkTest™ so that it can monitor your progress and protect you. If possible, have someone with you while you do the WalkTest™. Try to walk at a pace you can comfortably maintain for 6 minutes. You can walk in a circle or oval (as walking a track), in a square or rectangle (around a room), or in a straight line, turning as you reach the ends (walking back and forth in a hallway). While you are walking, the LifeVest will give you audible prompts about how much longer you are to walk. It will also tell you when to stop walking. It is alright if you need to stop and rest at any time. Continue walking when you are able. After the walk, you will answer the fatigue and shortness of breath questions again. It is also important that you only walk for 6 minutes as part of this WalkTest™. Listen for the voice prompt that tells you to “stop walking” after 6 minutes. When you hear this voice prompt, please stop walking. • Wear comfortable shoes. • Walk on a hard, flat surface. Do not walk on a treadmill. • Do not run or jog. This test monitors you while you are walking at a normal pace. • If you have any walking problems, or if you have an abnormal gait, such as foot dragging, shuffling, or limping, or if you need assistance while walking, such as by using a cane, walker or crutches, please tell your physician prescriber as it may produce inaccurate results. • The monitor gives you voice prompts throughout the WalkTest™, so you may prefer to do the WalkTest™ in a private location. So that you can hear the voice prompts, do not engage in any other activity like listening to music or talking on a cell phone. • If your physician prescriber asks you to do multiple WalkTests™, doing the walk in the same location gives the most accurate results.
Using the activities options 6 - 9 Why is it important that I do the WalkTest™? Your prescriber may use the information from the WalkTest™ to help evaluate your condition. It is very important that you indicate the true state of your condition when you answer the questions. Your physician prescriber may review your answers and use this information to help evaluate your condition. Taking the WalkTest™ now If you get this message “Please Complete WalkTest™” when you change your battery, your physician prescriber has asked that you perform a WalkTest™. Throughout the WalkTest™ procedure, you must wear the LifeVest, with it connected normally. You have the option of taking the WalkTest™ now or later. Make sure the electrode belt is connected to the monitor before starting the WalkTest™. During the WalkTest™, the LifeVest monitors your heart and counts your steps. The test takes six minutes to complete. If you receive an alert while walking, stop walking and press the response buttons. If you have any questions, please contact your physician. 1. Tap NOW to begin. • Tap Help for details.
Using the activities options 6 - 11 The monitor will display two pre - walk questions about your shortness of breath and fatigue levels ( how tired you feel). 4. Select your levels using the arrows to the left and right of the scale. 5. Tap ACCEPT on each screen to confirm and continue. 6. The WalkTest™ start screen appears. Tap START when you are ready to begin the test. A voice prompt instructs you to start walking. What you need to do during the WalkTest™ is described in the “What do I have to do?” section on page 6-8. To cancel the WalkTest™, tap X . If you cancel the WalkTest™ you will be asked to confirm that you really want to cancel. If you do want to cancel, tap X . If you do not want to cancel, tap RESUME . 7. A progress bar is displayed during the WalkTest™. You will receive a voice prompt after each minute of the WalkTest™. Continue walking for 6 minutes.
LifeVest 5000 Patient Manual 6 - 12 8. When the test is completed (after approximately 6 minutes), you are instructed to stop. Tap ACCEPT . 9. The shortness of breath and fatigue questions are displayed again with level rating screens. Select the numbers that best match your levels after the walk. Your answers DO NOT need to match your previous answers. Tap ACCEPT to confirm and continue to the last WalkTest™ screen. 10. Tap ACCEPT on this screen to close the WalkTest™ and return to the Home screen. After completing the WalkTest™, sit down and rest before resuming your normal activities. If you have any questions about these instructions, call ZOLL. If you have any questions about your medical condition, call your health care provider. During the data download, the LifeVest sends your WalkTest™ information to a secure website where your physician prescriber can review the results. Your physician prescriber may have you repeat the WalkTest™ at certain intervals. The LifeVest will remind you when you are scheduled to take the WalkTest™ by displaying a message on the monitor.
Using the activities options 6 - 13 Taking the WalkTest™ later If you choose to complete the WalkTest™ later, tap LATER to return to the Home screen. If you tap LATER another WalkTest™ prompt won’t be displayed until you change the battery. When you decide to complete the WalkTest™, access it by tapping MENU on the Home screen, then ACTIVITIES , and then WALKTEST™ .
LifeVest 5000 Patient Manual 6 - 14 WalkTest™ messages As you take the WalkTest™, you may get one of these messages. If so, here is what the message means and what you should do. If you get any other messages, see Section 5, Responding to alerts. Message What it means What to do You are attempting to take the WalkTest™ with the electrode belt disconnected. The belt needs to be connected to take the WalkTest™. Wear the LifeVest and connect the electrode belt to the monitor. After connecting the electrode belt, the message goes away. Try again to take the WalkTest™. You are attempting to take the WalkTest™ and the LifeVest is advising you not to take the WalkTest™ at this time. Tap ACCEPT to clear the message. Try again later (or wait until tomorrow). You are attempting to take the WalkTest™ more frequently than scheduled. Tap ACCEPT to clear the message. Wait until you get this message: “Please complete WalkTest™.”
Appendix A: Symbols and Icons Appendix A: Symbols and Icons Cell signal strength: LifeVest is in range of a cell network and can transmit data. Number of bars indicates signal strength. Note: These icons also appear on a different color background, such as green when sending data. • Registered, connected, data can be transmitted, white bars indicate signal strength. • Signal strength is too weak to send data. • Cell modem is powered but not functioning properly. • Not connected to ZOLL charger network server.
WiFi signal strength: WiFi networks are available for transmitting data. Note: These icons also appear on a different color background, such as green when sending data. • Connected to WiFi network, data can be transmitted, white bars indicate signal strength. • Signal strength is too weak to send data. • WiFi is powered/turned on but not connected to any access points. • WiFi is not functioning properly. • WiFi is not powered or turned off.
Battery levels that are displayed on the monitor. Green segments: Depict how much charge is left in the battery. Yellow battery: Call ZOLL for service. Red battery: Battery is low, a critical situation. Change battery as soon as possible and recharge battery. A-1 LifeVest 5000 Patient Manual Electrode belt symbol shows that the electrode belt is connected to the monitor. The electrode belt is not connected to the monitor. If not corrected, a gong alert sounds and the “belt not connected” screen is displayed. Help button: Tap this icon to see help screen information. X button: Tap this icon to close the screen. Round electrode good signal: Situation normal, no action required. Round electrode poor signal: Check round electrodes for cause of poor signal to fix the problem. Round electrode off skin: Round electrode is not making good contact with skin. No signal is detected. See Responding to alerts, section 5.
Battery: Do not incinerate.
Battery: Do not short circuit. Magnetic resonance (MR) unsafe. Laundering symbol: Normal cycle in warm water. Laundering symbol: Tumble dry warm. Laundering symbol: Only non-chlorine bleach, when needed. Laundering symbol: Iron on low temperature. Laundering symbol: No anti-static spray. Laundering symbol: No fabric softener. A-2 Appendix A: Symbols and Icons Manufacturing date. Manufacturing location. Expiration date. Automated external defibrillator. Dangerous voltage. Surface could become hazardous for bystanders to touch when the device is in use. CE marking, indicates conformance with European Medical Device Directive. Symbol for catalog number, accompanied by number. Symbol for serial number, accompanied by serial number. Symbol for lot number, accompanied by lot number.
Symbol for EC representative next to name and address of authorized EC rep.
Power supply electrical information: Alternating current (AC). Power supply electrical information: Direct current (DC). Therapy pad label: Place this side (silver side) of the therapy pad next to your skin. See instructions for use. Keep dry. Keep away from sunlight. Do not use if package is damaged. A-3 LifeVest 5000 Patient Manual Temperature limitation. Upper and lower limits of temperature are indicated next to the horizontal lines. Emits RF energy. Monitor connector: Type BF defibrillator-proof connector. Monitor connector: Type BF non defibrillator-proof connector. Packaging: Battery. Packaging: Charger. Packaging: Monitor.
Packaging: Electrode belt.
Packaging: Garment. WiFi icon. Tap this icon to find or access WiFi networks. Information icon. Tap this icon to access serial number information about the LifeVest components. Voice icon. Tap this icon to access volume controls and speak options for Help screens. Support mode icon. Tap this icon to enter support mode when directed to do so by ZOLL. WalkTest™ icon. Tap this icon on the Activities Menu screen to initiate the WalkTest™. Health survey icon. Tap this icon on the Activities Menu screen to initiate the Health Survey. Settings Menu icon. Tap this icon to view Voice, Airplane, WiFi, Info and Support settings.
A-4
Appendix A: Symbols and Icons A - 5 Send Data screen icon. Tap this icon to initiate sending data to ZOLL. Activities Menu icon. Tap this icon to access the health survey and WalkTest™. Airplane mode icon: Airplane mode disables the LifeVest’s wireless transmission capabilities to avoid interfering with aircraft and other electrical equipment operation. Use Airplane mode in any situation where cell phone use is prohibited in order to eliminate electrical interference. Therapy pad on skin: Situation normal, no action required. Therapy pad off skin: Check therapy pad that is off skin and fix problem. See Responding to alerts, section 5.
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Appendix B: Software Licensing Statement B - 1 Appendix B : Software Licensing Statement Certain software components (referred to herein as “Open Source Components”) that are used by the LifeVest 5000 wearable defibrillator are licensed by ZOLL Medical Corporation (referred to herein as “ZOLL Medical”) under various open source license agreements. As required by the terms of these open source license agreements, ZOLL Medical offers to make the source code corresponding to the Open Source Components, and any ZOLL Medical modifications thereof, available upon request. NO WARRANTY TO THE EXTENT PERMITTED BY APPLICABLE LAW, THE OPEN SOURCE COMPONENTS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY AGAINST INFRINGEMENT OR ANY VIOLATION OF INTELLECTUAL PROPERTY RIGHTS COVERING THE OPEN SOURCE COMPONENTS. IN NO EVENT UNLESS REQUIRED BY APPLICABLE LAW WILL ANY PARTY, INCLUDING ZOLL MEDICAL, BE LIABLE FOR DAMAGES, INCLUDING ANY GENERAL, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR INABILITY TO USE THE OPEN SOURCE COMPONENTS (INCLUDING BUT NOT LIMITED TO LOSS OF DATA OR DATA BEING RENDERED INACCURATE OR LOSSES SUSTAINED BY ANY PARTY FOR A FAILURE OF THE OPEN SOURCE COMPONENTS TO OPERATE WITH ANY OTHER PROGRAMS).
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Index Index-1 Index A about LifeVest system, 1-1 manual, 1-1 activities health survey, 6-1, 6-2 introduction, 6-1 taking the health survey, 6-3 WalkTest™, 6-1, 6-7 AED, A-3 aircraft use, 1-5 airplane mode, 2-6, 3-13 alerts add gel, 5-19 after treatment, 5-12 battery, 5-11 check belt, 5-16 check round electrodes, 5-15 electrode belt, 5-9, 5-14 gong, 5-5, 5-9, 5-11, 5-12, 5-14 informative, 5-6, 5-11, 5-12, 5-14 overview, 5-1 physiological, 5-1 remove excess gel, 5-20 replace belt, 5-17 responding to, 5-2 siren, 5-1, 5-4 technical, 5-5 therapy pads, 5-18 train whistle, 5-6 vibration and siren, 5-1 B backup power, 3-3 battery, 2-4 charger, 3-7 charging, 3-7 recharge, 3-7 recycling, 3-28 warning, 3-28 battery care, 3-3 battery label symbols, A-2 blank screen, 2-3 C call for help message, 5-4 cardiac defibrillation definition, 1-1 care battery, 3-3 caution, 4-10 detergent, 4-10 dryer, 4-10 laundry, 4-10 monitor, 3-26 non-wa shable items, 3-26 warning, 3-26 wash, 4-10 caution charger setup, 3-4 cautions, 1-2 and warnings, patient, 1-2 cell signal strength selected symbol, A-1 charger, 2-8 battery charger indicators, 2-8 battery indicator icons, 2-9 description, 2-1 charger icons, 3-6 battery full, 3-6 battery problem, 3-6 charger problem, 3-6 charging, 3-6 no battery, 3-6 charger setup, 3-4 change batteries, 3-7 daily, 3-7 recharge batteries, 3-7 clean caution, 4-10 detergent, 4-10 dryer, 4-10 laundry, 4-10 monitor, 3-26 non-washable items, 3-26 warning, 3-26 wash, 4-10 close or x button icon, A-2
LifeVest 5000 Patient Manual Index-2 components, 2-1 conscious, 5-2 contact ZOLL, ii cracks housing, 3-26 therapy pads, 3-26 D daily routine, 3-1 dark screen, 2-3 E ECG electrodes, 2-2 electrode belt connecting, 4-7 description, 2-1 disconnecting, 4-7 warnings, 4-7 electrodes, 2-2 EMI electromagnetic interference, 1-7 environment noise and vibration, 1-5 essential performance, 1-5 F family, 3-27 warnings, 3-27 FCC regulatory information, 1-8 finished with device, 3-28 G garment description, 2-1 position, 4-5 garment and electrode belt, 2-2, 4-1 assemble, 4-1 assembled, 4-3 disassemble, 4-9 female, 4-4 inside view, 4-3 outside view, 4-3 wearing, 4-4 gel add, 5-19 remove excess, 5-20 gong, 5-5 gong alerts general, 5-6 H health survey messages, 6-6 take it later, 6-5 take it now, 6-3 what to do, 6-2 why important, 6-2 help button icon, A-2 housing cracks, 3-26 how the LifeVest works, 1-1 I icon activities menu, A-5 airplane mode, A-5 charger battery indicators, 2-9 health survey, A-4 help, A-2 information, A-4 r ound electrode green, A-2 red, A-2 yellow, A-2 send data, A-5 settings menu, A-4 support mode, A-4 voice, A-4 volume, A-4 WalkTest™, A-4 WiFi, A-4 indications for use, 1-5 informative alert, 5-6 inspection, 3-26 intended use, 1-5 interference wireless, 1-8 L laundering, 4-10 symbols, A-2 warnings, 4-10 M meet the LifeVest, 2-1 monitor, 2-3 battery, 2-3 battery release button, 2-3 connector, 2-3
Index Index-3 description, 2-1 response buttons, 2-3 speaker, 2-3 status indicators, 2-3 touchscreen, 2-3 monitor touchscreen, 2-5 battery status icon, 2-6 electrode belt status icon, 2-6 menu button, 2-6 patient name, 2-6 N non-washable items battery charger, 3-26 cables, 3-26 monitor, 3-26 round electrodes, 3-26 therapy pads, 3-26 normal startup routine, 3-2 O operator profile, 1-6 P patient warnings and cautions, 1-2 patient age, 1-5 patient menu screen, 3-9 activities menu, 3-9 send data, 3-9 settings menu, 3-9 patient profile, 1-6 patient training, 1-6 phone number, ii power outage, 3-3 power supply, 2-8 profile operator, 1-6 patient, 1-6 ZOLL authorized representative profile, 1-6 R rate description answer scale, 6-10 recharge batteries, 3-7 recording heart rhythm, 2-6, 3-8 recycle, 3-28 replace belt, 5-17 response buttons location, 2-3 return, 3-28 battery, 3-28 round electrode, 2-2 round electrode Velcro attachment areas description, 2-2 routine daily, 3-1 normal, 3-2 S safety information, 1-2 send data manually, 3-11 showering and bathing warnings, 4-8 siren call for help message, 5-4 siren alert, 5-1 responding to, 5-2 sleep mode, 2-3 standby screen, 2-3 status indicators, 2-3 support mode, 3-24 symbol AED Automated external defibrillator, A-3 battery call ZOLL, A-1 charging, A-1 incinerate, A-2 level, A-1 needs charged, A-1 short circuit, A-2 BF, A-4 BF non DP, A-4 CE marking, A-3 cell signal strength, A-1 dangerous voltage, A-3 DC power electrical, A-3 Do not use if package damaged, A-3 EC REP, A-3 electrode belt, A-2 electrode belt connector, A-2 expiration date, A-3 Keep away from sunlight, A-3 Keep dry, A-3 laundry, A-2 dryer, A-2
LifeVest 5000 Patient Manual Index-4 low temperature, A-2 no anti-static spray, A-2 no fabric softener, A-2 LOT, A-3 magnetic resonance, A-2 manufacturing date, A-3 location, A-3 MR unsafe, A-2 non chlorine bleach, A-2 packaging battery, A-4 charger, A-4 electrode belt, A-4 garment, A-4 monitor, A-4 power supply electrical, A-3 REF, A-3 RF energy, A-4 See instructions for use, A-3 SN, A-3 temperature limitation, A-4 WiFi signal strength, A-1 symbols and icons, A-1 system information, 3-23 T technical alerts, 5-5 therapy pad pockets description, 2-2 therapy pads cracks, 3-26 green, A-5 label, A-3 red, A-5 treatment prevent, 1-1 U unconscious, 5-2 using the LifeVest, 3-1 daily routine, 3-1 normal startup routine, 3-2 V vibration, 5-1 vibration box area description, 2-2 voice mode, 3-10 options, 3-10 volume, 3-10 W WalkTest™ how it works, 6-7 importance, 6-9 messages, 6-14 rate description answer scale, 6-10 take it later, 6-13 take it now, 6-9 warnings, 6-7 what to do, 6-8 warnings, 1-2, 1-4, 3-26, 3-27, 3-28, 4-7, 4-8, 4-10, 6-7 and cautions, patient, 1-2 s iren alert, 5-2 WiFi, 3-15 accessing available networks, 3-15 clearing all saved networks, 3-22 deleting networks, 3-22 entering a hidden network, 3-20 searching for networks, 3-15 wireless interference, 1-8 Z ZOLL contact, ii ZOLL authorized representative profile, 1-6

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