Biowatch Medical VST3 Vital Signs Transmitter Model VST3 User Manual 103 0038 UserManual Final

Biowatch Medical, Inc. Vital Signs Transmitter Model VST3 103 0038 UserManual Final

Contents

Users manual

Personal Health Monitoring ServicesSMVITAL SIGNS TRANSMITTER™• MODEL: VST3TMInstruction Manual
1TABLE OF CONTENTSIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2Get to Know Your Vital Signs Transmitter . . . . . . . . . . . .4How the Vital Signs Transmitter Works . . . . . . . . . . . . .5Clinical Monitoring Center Intervention . . . . . . . . . . . .5Emergency Medical Service (EMS) Intervention . . . . . . .6Event Button Intervention . . . . . . . . . . . . . . . . . . . . . . .6Immediate Voice Response Intervention . . . . . . . . . . . . .6Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7When to Wear Your Vital Signs Transmitter . . . . . . . . . . .8Using the Vital Signs Transmitter for the First Time . . . .9Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Charging the Vital Signs Transmitter . . . . . . . . . . . . . .12How to Wear Your Vital Signs Transmitter . . . . . . . . . .15Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .17Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . .21
2INTRODUCTIONThank you for purchasing Biowatch Medical’s vital signs transmitter, model number VST3. The vital signs transmitter is a comfortable, easy-to-use personal health monitoring device thatmay be worn continuously 24 hours a day. The vital signs transmitter automatically transmits medical data viathe cellular modem to the Clinical Monitoring Center wheneveryour electrocardiogram (ECG) or other monitored physiologicalparameters exceed normal limits. Critical care specialists at theClinical Monitoring Center will analyze data as it is received fromthe vital signs transmitter and may then communicate directlywith you and take whatever action is deemed most appropriate atthat time. If for any reason you are unable to respond, EmergencyMedical Service (EMS) personnel will be dispatched to your location using the information provided by the global positioningsystem (GPS). The monitoring service also provides an Immediate VoiceResponse service option that allows you to depress the EventButton to alert and speak directly with the critical care specialists at the Clinical Monitoring Center at any time, for any reason.Your vital signs and clinical reports are also available to authorizedpersonnel (i.e., yourself, physician, relative, guardian, etc.) who maysecurely “log on” to www.biowatchmed.com to view these reportsfor evaluation and tracking.
3How the vital signs transmitter and Personal HealthMonitoring Services should be used:•To monitor ECG and heart rate •The vital signs transmitter also captures:- body temperatureDO NOT use the vital signs transmitter and Personal HealthMonitoring Services:•To diagnose heart disease•To replace physician check-upsThe vital signs transmitter is intended for use by only the registered user and should NOT be shared with others.DO NOT use the vital signs transmitter in combination with an external cardiac defibrillator.WARNINGTYPE BF1. Instruction Manual2. Guide to Getting Started3. VST3Monitoring Belt4. Medium Elastic Strap5. AC Power Adapter6. Notice of Privacy Practices7. Personal Health MonitoringServices Brochure8. Warranty Card9. Products & Services AgreementThese items are included with your vital signs transmitter:
4GET TO KNOW YOUR VITAL SIGNSTRANSMITTERThe vital signs transmitter uses built-in electrodes and otherphysiological sensors to monitor and capture two channels of electrocardiogram (ECG) including heart rate and bodytemperature. The built-in cellular data modem and phoneprovide both data and voice communications between youand Biowatch Medical’s Clinical Monitoring Center. The vital signs transmitter also uses a rechargeable battery and a GPS.Front ViewSpeakerCharging PortVST3Rear ViewElectrodesMicrophoneEvent ButtonLED Charging Indicator
5How the Vital Signs Transmitter WorksThe vital signs transmitter automatically transmits a notifica-tion via its cellular modem to the Clinical Monitoring Centerwhenever your ECG or other physiological parameters exceednormal limits. Clinical Monitoring Center InterventionIf the Clinical Monitoring Center staff determines that it isnecessary to contact you due to an abnormal ECG or otherphysiological abnormality, they will do so by placing a call tothe vital signs transmitter. When an incoming call is receivedby the vital signs transmitter, it will vibrate to alert you of theincoming call. Within five seconds of this vibration, a voicechannel is opened and allows the critical care specialists at theClinical Monitoring Center to communicate directly withyou and take whatever action is deemed most appropriate atthat time.
6Emergency Medical Service (EMS) InterventionIf for any reason you are unable to respond, EMS personnelwill be dispatched to your location using the informationprovided by the GPS.Event Button InterventionThe vital signs transmitter also provides an Event Button thatallows you to alert the critical care specialists when you feeldizziness, pain, palpitations or other medical symptoms.To send an alert, depress and release the Event Button. Oncethe Event Button has been fully depressed, the vital signstransmitter will vibrate to notify you that your medical datahas been transmitted for review. The data is reviewed and analyzed by the critical care specialist who will initiate furtherinterventional activities if needed.Immediate Voice Response Intervention* To use the Immediate Voice Response service option, depressthe Event Button.* This is an optional service feature that requires additional monthly and per-use fees.
7NotificationsAny time that critical care specialists need to communicatewith you or send a notification, they first notify you silentlyby sending a signal that causes the vital signs transmitter tovibrate. Approximately five seconds after the vibration, a briefmessage will be played for each of the following types of notifications:•Occurrence of an event that has not been transmitted tothe Clinical Monitoring Center because you are outside ofcellular coverage area•Low battery level•Insufficient battery level for normal function•Call from Clinical Monitoring Center•Vital signs transmitter has become too loose for normal operation To delay the automatic playing of a message following thevibration, depress the Event Button immediately followingthe notification vibration.The message will be delayed 30 seconds before being played.Please note that, for your safety, a 911 notification or similartype of Emergency Event cannot be delayed by the depressionof the Event Button, and the incoming message will be played.Message notifications that are received while you are notwearing your vital signs transmitter will be stored and automatically played back the next time you apply the vitalsigns transmitter to your body. Refer to the “How to WearYour Vital Signs Transmitter” section for instructions on how to apply the transmitter.
8WHEN TO WEAR YOUR VITAL SIGNSTRANSMITTERThe vital signs transmitter should be worn any time you wantyour vital signs monitored. It is suggested that you wear thevital signs transmitter at all times, except when the belt couldbe subjected to water or other damaging environmental conditions or when the belt is being charged.The vital signs transmitter can be worn during periods ofphysical exertion under which normal perspiration occurswithout adversely affecting the transmitter.Please see the “Technical Specifications” section for acceptableoperating conditions.When NOT to Wear: The vital signs transmitter should notbe worn while you are bathing/showering, swimming or participating in any other activities that would require thebelt to be submerged or continuously exposed to water.The vital signs transmitter should not be worn while it isbeing charged.The vital signs transmitter should not be worn onto anycommercial aircraft. It can, however, be stored in baggageduring air travel.WARNING
9USING THE VITAL SIGNS TRANSMITTER FOR THE FIRST TIME1. Subscribe to Personal Health Monitoring Services.In order to initiate the monitoring, you must subscribe to the Personal Health Monitoring Services. Refer to thesection labeled “Getting Started” for more information.2. Provide account set-up information. Based on the serviceoptions you have purchased, additional account set-upinformation may be needed. Examples include emergencyand physician contact information, setting/resetting passwords and setting family and physician access toreports. Refer to the section labeled “Getting Started” for set-up instructions. 3. Charge the vital signs transmitter. The vital signs transmitterneeds to be fully charged overnight prior to the first use.Refer to the section labeled “Charging the Vital SignsTransmitter” for charging instructions.4. Put on the vital signs transmitter. Refer to the sectionlabeled “How to Wear Your Vital Signs Transmitter” toensure that the vital signs transmitter is worn properly.5. View reports and other account information. To accessand view activity reports and account information on theInternet, refer to the section labeled “Getting Started.”
10Getting Started 1.Subscribe to Biowatch Medical’s Personal HealthMonitoring Services. You can subscribe by callingBiowatch Medical direct at 1-877-BIOWATCH (1-877-246-9282) or by completing the online subscrip-tion process at www.biowatchmed.com/subscribe.For more information on the available service options,please refer to the Subscription Services and Optionsbrochure included in the vital signs transmitter packaging,visit our website, www.biowatchmed.com, or call our customer service center at 1-877-BIOWATCH (1-877-246-9282).2. Provide account set-up information. After you have subscribed to Biowatch Medical’s Personal HealthMonitoring Services, you are ready to enter account set-up information. This may be completed via our website at www.biowatchmed.com or by calling our customer service center at 1-877-BIOWATCH(1-877-246-9282). You will be asked to provide the information listed in thechart on the following page. Actual required informationmay vary based on the service options that were ordered aspart of your monthly subscription agreement.
11Service subscription and account set-up is complete.Congratulations! You have completed the first steps to beginning your Personal Health Monitoring Services. Note: You can still add additional service options at any time, even after theinitial service subscription and account set-up have been completed. Service Options that Require Information as Part of the Account Set-up Procedure Information NeededEmergency contact(s) Name, relationship to you, phone numbers* Physician contact(s) Name, type of physician, phone numbers* Activity Reporting Name, relationship to you, level of access (Personal, Family (choose between daily activity reports or Physician) or physician)* Physician Access to Name, type of physicianReal Time DataPasswords may also be reset during this process.*Indicates optional features that have associated monthly fees. You will not be required to enter information for these options if you have not purchased them as part of your service agreement.
Charging the Vital Signs TransmitterCharging for the First Time:The vital signs transmitter needs to be fully charged overnightprior to its first use. Charging/Recharging the Battery:1. Remove the vital signs transmitter from your torso.2. Insert the AC adapter plug into the wall (standard UShousehold electrical outlet: 120V AC outlet, 50-60 cycles).3. Insert the AC adapter cord intothe jack on the bottom edge ofthe vital signs transmitter.4. The LED indicator located onthe bottom right-hand side ofthe front label will light with a yellow indicator whilethe battery is being charged.When the battery has been fully charged, the LED indicator light will change from yellow to green. Once theLED indicator light is green, you know your battery isfully charged and the vital signs transmitter is ready for use.* If the LED indicator does not light when the AC adapter is in use, contact our customer service center at 1-877-BIOWATCH (1-877-246-9282) for further assistance. 12
13Audible Low Battery Warning:The vital signs transmitter has a rechargeable battery that typically, under normal use, maintains a charge for 32 hours.The vital signs transmitter provides a notification vibration,which, after an approximate five-second delay, is followed by a voice recording stating that the battery has reached thelevel where it needs to be recharged. This vibration/recordingwill be played when the battery level has dropped to 20% ofits capacity.Audible Warning of Shutdown:Once the battery has been depleted to a level where it can nolonger maintain the function of the vital signs transmitter, itwill provide a notification vibration. After a five-second delay,a final message will be played stating that the vital signs transmitter has insufficient battery level to maintain normalfunction and is turning itself off. Maintaining a Charged Vital Signs Transmitter:In order to maintain an adequate charge, it is recommendedthat you charge the battery each day by charging the belt for aminimum of 20 minutes. Simply remove the vital signs trans-mitter from your torso, plug the adapter into the transmitterand leave it there for 20 minutes. If you do this once a day,your battery should remain adequately charged.The vital signs transmitter should never be charged while it is being worn. Wearing the transmitter while the AC poweradapter is plugged into the wall and the belt could result inserious personal injuryWARNING
14AC Adapter:To recharge your battery, use only the specific AC Adaptermodel #GTM21089-1305-W3 that was packaged with thevital signs transmitter. ,Other adapters may vary in output voltage and/or polaritiesand may damage the vital signs transmitter. BiowatchMedical, Inc. is not responsible for damage that occurs whenother AC adapters are used.For replacement AC Adapters and other purchasing informa-tion, contact Biowatch Medical Inc. at 1-877-BIOWATCH(1-877-246-9282), or visit our website atwww.biowatchmed.com.CAUTION: To avoid possible damage to the vital signs transmitter, useonly the specific model #GTM21089-1305-W3 AC adapter that waspackaged with the vital signs transmitter. This specialized adapter is onlyavailable from Biowatch Medical, Inc. Additional AC adapters may be purchased by calling 1-877-BIOWATCH (1-877-246-9282).
15How to Wear Your Vital Signs Transmitter1. To connect, insert circular plastic end of elastic strap intoslot on the end of the vital signs transmitter and twist.2. Adjust the strap length to fit snugly and comfortablyaround your chest, just below the chest muscles (sternumarea). The vital signs transmitter should fit snugly so thatyou can only insert a smallfinger between the belt and your skin. If you hear a notification that the belt has become too loose tomaintain normal operation,the strap should be adjustedand the vital signs transmit-ter should be reapplied asindicated here.
16Lift the vital signs transmitter off your chest and moisten the four rectangular electrode areas on the back of the transmitter. Please refer to the diagram of the vital signs transmitter’s components included in the “Getting to Know Your Vital Signs Transmitter” section to locate the electrode areas.3. Ensure the electrode areas are firmly against the skin. The Biowatch Medical logo on front of the vital signstransmitter should be upright in the middle of the chest so that it can be read by a person standing in front of you. 4. Verify that the vital signs transmitter is working properlyby listening for a message notification that will be automat-ically played within the first 10 seconds that the transmit-ter has been secured to your body as indicated above. * If a notification message is not played, call our customer service center at 1-877-BIOWATCH (1-877-246-9282). Do not assume that the vital signstransmitter is functioning as intended if a notification message is not played.
WARNING17CARE AND MAINTENANCEThe vital signs transmitter is very easy to maintain. Weeklycleaning is recommended and very little troubleshooting, ifany, is ever required.Cleaning1. Remove the elastic strap from the vital signs transmitter.2. To clean the transmitter:• wipe with a cloth dampened with mild soap and water • next wipe with a cloth dampened with pure water toremove any remaining soap residue• thoroughly dry the vital signs transmitter with a softtowel 3. To clean the elastic strap:• hand wash in warm soapy water• lay strap flat and air dryStore the vital signs transmitter, when not in use, in a clean,dry place that is within the specified storage temperaturespublished in the section labeled “Technical Specifications.”DO NOT submerge the vital signs transmitter in water orany other liquid solution! Avoid getting water or any other liquid in any of the deviceopenings.Biowatch Medical Inc. will not warranty vital signs transmit-ters that have been water damaged due to submersion.
18TroubleshootingThe vital signs transmitter does a daily diagnostic test withthe Clinical Monitoring Center. No action is required by youto troubleshoot the transmitter.If you are concerned that your vital signs transmitter is not functioning properly, please contact our customer service center at 1-877-BIOWATCH (1-877-246-9282).Please see the “Limited Warranty” section for additionalinformation on returning the vital signs transmitter while it is under the warranty protection period.
19LIMITED WARRANTYYour vital signs transmitter is warranted, under normal use, tobe free from manufacturing defects for one year from the dateof purchase. In the event of failure of your vital signs transmitter, first contact customer service at 1-877-BIOWATCH (1-877-246-9282). If it is confirmed that the vital signs transmitter is malfunctioning, then do the following:1. Securely package the vital signs transmitter along with: • proof of purchase• a note including purchase date, a brief description of the malfunction and your name, address and phone numberLimitations related to this warranty are as follows:• Tampering with the vital signs transmitter voids the warranty. The vitalsigns transmitter is explicitly NOT designed to be opened by anyoneother than Biowatch Medical personnel.• The warranty is only extended to the original purchaser (i.e. it is nottransferable).• To validate the warranty, you are required to return the enclosed registration card, or complete it online at www.biowatchmed.com,within 10 days of initiation of the monitoring service.
202. Ship the package to the following address: (Insurance is recommended)Biowatch Medical, Inc. Attention: Warranty1233 Washington Street, Suite 400 Columbia, SC 29201 FOR CUSTOMER SERVICE, CALL TOLL FREE:1-877-BIOWATCH (1-877-246-9282)
21TECHNICAL SPECIFICATIONSVital Signs TransmitterModel VST3FCC ID SC7VST3Vital Signs Monitored ECG, body temperatureData Storage 8 MB (up to 48 hrs w/o cellular transmission)Material, strap elasticMaterial, vst pellethane plasticBattery Type3.6V non-user replaceable lithium polymer cellAC Adapter 5V 1A wall plug adapter moduleStorage Humidity 0-95% relative, non-condensingStorage Temperature 0-140 degrees FUsage Temperature 40-110 degrees FUsage Humidity 0-90% relative, non-condensingWater Resistance water resistant/NOT waterproofOuter Dimensions ~ 21.75" x 1.6" x 0.5" (VST3)~ 14" x 1" x 0.2" expandable to~ 33" x 1" x 0.1" (elastic strap)Weight ~ 6 oz. (VST3)~ 1 oz. (elastic strap)Clinical Monitoring Center Monitoring ServicesAvailability 24 hours a day, 7 days a week, 365 days a yearService Reliability redundant backend systemsData Storage unlimitedStaff Certification certified clinical care technicians Facility CertificationCMS (HCFA)-Independent Diagnostic Testing FacilityHIPPA-CompliantCritical Events special intervention for critical events Online Reports samples available upon request
22It is recommended that the purchaser fill out the followinginformation and retain for his/her files.Purchaser Name___________________________________Date of Purchase __________________________________Serial Number ____________________________________NOTES_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
1-877-BIOWATCH1-877-246-9282www.biowatchmed.com

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