Page 1 Wearable Cardioverter Defibrillator Model 5100 Patient Manual Contact toll free (USA and Canada): 1-800-543-3267 20B0097 Rev C 2022-10...
Page 3 • Round electrodes touch your skin. • Nothing is between the round electrodes and your skin. • Garment ﬁts snugly. See the LifeVest WCD 5100 Patient Manual for more information. Ques�ons? Call ZOLL 24 hours a day at 1-800-543-3267 Con�nued on other side...
Page 4 © 2022 ZOLL Medical Corpora�on. All rights reserved. ZOLL, LifeVest, and Blue are trademarks or registered trademarks of ZOLL Medical Corpora�on in the United States of America. All other trademarks and registered trademarks are property of their respec�ve owners. Con�nued on other side...
Page 5: Table Of Contents
Contents Contents 1: Meet the LifeVest® wearable cardioverter defibrillator system LifeVest® WCD system components LifeVest® monitor Charger and battery Garment and electrode belt Essential performance Indications for use Contraindications Intended use locations Safety information 1-10 Before use 1-11 Receiving a treatment 1-12 Receiving alerts 1-13...
Page 6 Responding to Check Garment and Electrodes message 4-11 Responding to therapy pad problem message 4-12 Responding to Add Gel to Therapy Pads message 4-13 Responding to Call ZOLL message 4-15 Responding to Too Much Gel, Clean Skin message 4-16 Responding to WARNING message 4-17...
Page 7 Contents Responding to Remove Battery message 4-22 Responding to Send Data message 4-22 5: Performing activities Health survey activity Taking the health survey Taking a delayed health survey WalkTest® activity Performing the WalkTest® activity 5-10 Performing a delayed WalkTest® session 5-16 6: Using the monitor's functions Manually recording your heart rhythm...
Page 8 LifeVest® WCD Patient Manual Indicators Buttons Graphics Screens Appendix C: Charger indicator glossary Appendix D: Technical information Environmental conditions Specifications System life expectancy Auditory alert signal information Alert system reminder signals and intervals Monitor alerts, high priority Monitor alerts, medium priority D-10 Monitor alerts, low priority D-11...
Page 9: Copyright And Trademarks
Information, operation, specifications, and product appearance may change without notice. Names and data used in examples are fictitious. Copyright and trademarks © 2022 ZOLL Medical Corporation. ZOLL, LifeVest, WalkTest, Blue, and the color blue are trademarks and/or registered trademarks. Patent Patent information is available at www.zoll.com/patents.
Page 10: Contact Information
ZOLL Software; or iv. removing the ZOLL Software from the LifeVest WCD device. Title to the ZOLL Software will remain at all times with ZOLL. You must keep the ZOLL Software confidential. Contact information...
Page 11: About This Manual
Contents About this manual This manual: is for patients who are using the LifeVest WCD. gives you instructions on the use and care of the LifeVest WCD. is intended to supplement the training you received when you were fitted with the LifeVest WCD. Page vii...
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Page 13 1: Meet the LifeVest® WCD system This section provides general information about the LifeVest WCD system including: Introduction to the LifeVest WCD system components Essential performance Indications for use Contraindications Intended use locations Safety information, such as warnings and cautions Information for non-patient/bystander Known residual risks Environmental considerations related to noise and vibration...
Page 15: 1: Meet The Lifevest® Wearable Cardioverter Defibrillator System
Meet the LifeVest® WCD system 1: Meet the LifeVest® wearable cardioverter defibrillator system The LifeVest wearable cardioverter defibrillator (WCD) is worn by a patient at risk for sudden cardiac arrest and who is not a candidate for or refuses an implantable defibrillator. It is lightweight and easy to wear, allowing patients to return to their activities of daily living.
Page 16: Lifevest® Wcd System Components
LifeVest® WCD Patient Manual LifeVest® WCD system components Item Description 1 Monitor The main unit of LifeVest WCD system. The monitor connects to the electrode belt for the purposes of monitoring your heart rhythm and delivering defibrillating treatment, if needed. In the image, the electrode belt is shown connected, and the monitor is powered on.
Page 17: Lifevest® Monitor
Meet the LifeVest® WCD system LifeVest® monitor Front Back Item Description 1 Monitor Displays status of the monitor. See “Reading the monitor indicator light” on page 3-10. status indicator light 2 Response Two buttons, located front and back. See “Using the LifeVest®...
Page 18: Charger And Battery
LifeVest® WCD Patient Manual Charger and battery Note: The combination of the charger and power supply form a medical electrical system. Item Description 1 Battery Supplies power to the LifeVest WCD. See “Charging and changing batteries” on page 3-15. 2 Charger Holds the battery for recharging.
Page 19: Garment And Electrode Belt
Meet the LifeVest® WCD system Garment and electrode belt The garment is worn under your clothing to hold the electrode belt (which consists of the vibration box, round electrodes, and therapy pads) against your chest and back. Garment Item Description 1 Colored Correspond to the colored fasteners on the electrode belt and are used to attach the electrode belt to the garment.
Page 20 LifeVest® WCD Patient Manual Garment detail Item Description 1 Size and care The size and care label shows the size of the garment, and symbols indicate how to care for the garment. label For details about these symbols, see “Symbols glossary”...
Page 21 Meet the LifeVest® WCD system Item Description 7 Vibration box The fabric flap is folded over to secure the vibration box. fabric flap 8 Vibration box The vibration box is placed in this area. position 9 Therapy pad The therapy pads are placed in the pockets with the green labels.
Page 22 LifeVest® WCD Patient Manual Electrode belt Item Description 1 Round Sense your heart’s electrical signal for the monitor. electrodes 2 Therapy Deliver a treatment to your heart. Blue™ gel disperses from the therapy pads before treatment is delivered. Additional pads Blue™...
Page 23: Essential Performance
Meet the LifeVest® WCD system Essential performance The essential performance of the LifeVest WCD is that it detects ventricular fibrillation or ventricular tachycardia, then delivers a defibrillating shock. Indications for use The LifeVest WCD 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.
Page 24: Safety Information
LifeVest® WCD Patient Manual Safety information This information helps you safely operate the LifeVest WCD. Read and understand these warnings and cautions before using the LifeVest WCD. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Page 25: Before Use
Meet the LifeVest® WCD system Before use WARNING Do not use the LifeVest WCD until you receive training and understand the manual. If you do not understand how to use the LifeVest WCD, you may damage it, cause the system to malfunction, and/or cause serious injury or death.
Page 26: Receiving A Treatment
LifeVest® WCD Patient Manual WARNING If you do not hear the gong upon receiving the prompt to activate the LifeVest WCD, the LifeVest WCD may have malfunctioned. If you were to enter into a life-threatening arrhythmia, a system malfunction may result in serious injury or death.
Page 27: Receiving Alerts
Meet the LifeVest® WCD system WARNING CPR can be performed, but bystanders must not touch the patient while a treatment is being delivered. Anyone touching the patient during a treatment may be shocked, which may result in injury to the bystander.
Page 28: Using The Lifevest® Wcd
LifeVest® WCD Patient Manual Using the LifeVest® WCD WARNING Always operate the system within its environmental ranges. Operating the LifeVest WCD outside of these ranges may damage it and/or cause the system to malfunction, which may result in serious injury or death. See “Environmental conditions”...
Page 29 If you see Blue™ gel other than during a treatment, this may indicate a damaged electrode belt and may cause the system to malfunction, which may result in serious injury or death. Call ZOLL immediately at 1- 800-543-3267. Inspect the LifeVest WCD for damage. See “Inspecting the LifeVest®...
Page 30: Caring For Lifevest® Wcd Components
Changes or modifications to this device not authorized by ZOLL could void the radio frequency energy (RF) compliance and negate your authority to operate the device. Do not disassemble the unit.
Page 31: Interactions With Other Medical Equipment
Meet the LifeVest® WCD system WARNING Conductive parts of round electrodes and therapy pads and associated connectors should not contact other conductive parts including the earth. If this should occur, it could affect the ability of the LifeVest WCD to function properly, which may result in serious injury or death. Do not steam, autoclave, or gas sterilize any part of the LifeVest WCD system.
Page 32: Information For Non-Patients/Bystanders
LifeVest® WCD Patient Manual Information for non-patients/bystanders WARNING Only the patient should press the response buttons. The patient’s ability to press both response buttons lets the LifeVest WCD know whether or not the patient is conscious and is critical in deciding when to give the patient a treatment.
Page 33 Meet the LifeVest® WCD system Screen Non-patient/bystander DO NOT actions Do not do anything. Do not respond to messages Note: The LifeVest and alerts in WCD will direct a place of the conscious patient to patient. respond to messages Do not press and alerts.
Page 34: Known Residual Risks
LifeVest® WCD Patient Manual Known residual risks A rash or skin irritation is a potential risk with LifeVest WCD use. If you experience skin irritation, which may include redness, itching, or swelling, and you believe that medical attention is required, consult your health care professional.
Page 35: Environmental Considerations Related To Noise And Vibration
Meet the LifeVest® WCD system Environmental considerations related to noise and vibration Certain environments or situations you encounter that are loud and have high vibration could affect the LifeVest WCD. A loud environment could make it difficult for you to hear an alert to be able to appropriately respond.
Page 36: Electromagnetic Interference
LifeVest® WCD Patient Manual Electromagnetic interference WARNING Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. If this should occur, it could affect the ability of the LifeVest WCD to function properly, which may result in serious injury or death.
Page 37 Meet the LifeVest® WCD system 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.
Page 38: Wireless Interference
Changes or modifications to this device not authorized by ZOLL could void the radio frequency energy (RF) compliance and negate your authority to operate the device. Do not disassemble the unit.
Page 39 General precaution – If you experience any interference with the LifeVest WCD when in the presence of any other wireless device, move away from the device or stop using it. If you continue to have problems, call ZOLL at 1-800-543-3267. Page 1-25...
Page 40: Operator Profiles
“Cleaning the LifeVest® WCD system” on page 3-43. The patient is not expected to do any service on the LifeVest WCD. Only ZOLL is to perform service on the LifeVest WCD. The LifeVest WCD is to be returned to ZOLL for service.
Page 41: Patient Training
Health care professional profile Health care professionals evaluate the patient and prescribe the LifeVest WCD. Health care professionals also access patient data in ZOLL Patient Management Network. Health care professionals can prescribe settings for the LifeVest WCD. Information for health care professionals is provided in the LifeVest WCD 5100 Clinical Manual.
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Page 43: 2: Getting Started
2: Getting started This section provides information about getting started with the LifeVest WCD system including: At home with your LifeVest WCD system Inspecting the LifeVest WCD equipment Getting help with the LifeVest WCD...
Page 45 At home with your LifeVest® WCD system It is important you understand and complete the following steps when you are at home with your LifeVest WCD system. If you need assistance, call ZOLL at 1-800-543-3267. Always Ensure you are wearing the electrode belt and garment correctly.
Page 46: Inspecting The Lifevest® Wcd Equipment
Wash the previously worn garment. See “Garment care” on page 3-45. Inspecting the LifeVest® WCD equipment Inspect the LifeVest WCD equipment daily. If you should notice any of the following conditions, call ZOLL immediately at 1-800-543-3267. You are Page 2-2...
Page 47: Getting Help With The Lifevest® Wcd
Getting started not expected to do any service on the LifeVest WCD. Only ZOLL is to perform service on the LifeVest WCD. Cracks in the housing of the monitor, battery, or charger. Cracks in the therapy pads. Garment damage, such as tears or degradation of snaps and colored hook and loop fasteners.
Page 48 LifeVest® WCD Patient Manual Getting help with LifeVest® WCD screen instructions Some LifeVest WCD monitor screens include a Help button . Tap the Help button for more specific help for that screen's message. To hear the help message, tap the message on the screen. The message is spoken in the language displayed.
Page 49 3: Using the LifeVest® WCD system This section provides information about using the LifeVest WCD system including: Daily routine and normal startup Wearing the LifeVest WCD, including assembling the electrode belt to the garment, putting it on, connecting the electrode belt to the monitor, using the monitor’s indicator lights and response buttons, and using the batteries and charger.
Page 51: 3: Using The Lifevest® Wcd
Using the LifeVest® WCD system 3: Using the LifeVest® WCD Daily routine and normal startup WARNING If you do not hear the gong upon receiving the prompt to activate the LifeVest WCD, the LifeVest WCD may have malfunctioned. If you were to enter into a life-threatening arrhythmia, a system malfunction may result in serious injury or death.
Page 52 When you hear the gong and feel the vibration on your back, press and release both response buttons. If you do not hear the gong or feel the vibration, call ZOLL immediately at 1-800-543-3267. Ensure the monitor indicator light is green, fading in and out.
Page 53 Using the LifeVest® WCD system Check the monitor; it should display your name and the battery level. If your name is not displayed, call ZOLL immediately at 1-800- 543-3267. For details on the battery status icons on the monitor, see “Reading the monitor indicator light”...
Page 54 LifeVest® WCD Patient Manual 10 When you shower or bathe, remove the battery and completely remove the LifeVest WCD. See “Removing the LifeVest® WCD when you shower or bathe” on page 3-36 for details. 11 Change and wash the garment every 1 or 2 days.
Page 55: Wearing The Lifevest® Wcd
Using the LifeVest® WCD system Wearing the LifeVest® WCD The garment is worn directly against your skin under your clothing to hold the round electrodes and therapy pads against your upper body. The electrode belt is connected to the monitor. The monitor is placed in its holster and worn around your waist, over your shoulder, or across your torso using the adjustable strap.
Page 56: Wearing The Monitor In Its Holster
LifeVest® WCD Patient Manual Wearing the monitor in its holster Your LifeVest WCD holster comes with one adjustable piece and two extension pieces. Adjustable piece Long extension piece Short extension piece The adjustable piece and your selected extension piece form the strap you attach to the holster so you can wear the monitor around your waist, over your shoulder, or across your torso.
Page 57 Using the LifeVest® WCD system 4 Connect the buckles. 5 Press the clasp open on one end of the strap. 6 Hook the clasp onto one of the monitor’s strap rings. 7 Release the clasp. Page 3-7...
Page 58 LifeVest® WCD Patient Manual 8 Repeat steps 6 and 7 with the other side of the strap. 9 Adjust the strap as needed for your desired fit. Page 3-8...
Page 59 Using the LifeVest® WCD system Inserting a charged battery into the LifeVest® WCD Insert a fully charged battery into the LifeVest WCD every 24 hours or when you are putting on the LifeVest WCD. When you put the LifeVest WCD on, put the battery in last. To insert a battery into the LifeVest WCD: 1 Pull the battery latch to remove the fully charged battery from the...
Page 60: Reading The Monitor Indicator Light
LifeVest® WCD Patient Manual Reading the monitor indicator light WARNING If the monitor indicator light is not blinking, the LifeVest WCD may have malfunctioned. If you were to enter into a life-threatening arrhythmia, a system malfunction may result in serious injury or death. If you suspect the monitor indicator light is not working properly on the LifeVest WCD, see “Troubleshooting issues with no screen message”...
Page 61: Using The Response Buttons
Using the LifeVest® WCD system Using the response buttons If you receive the siren alert, you should, if conscious, press and release both response buttons to stop from getting a defibrillating treatment. You do not have to hold the response buttons to stop treatment. During normal monitoring, the monitor touchscreen may display a dark screen.
Page 62: Using The Monitor Screen
LifeVest® WCD Patient Manual Using the monitor screen The monitor screen displays information, messages, and menus related to LifeVest WCD operation, and allows you to interact with the LifeVest WCD. On certain screens, you can play audio associated with the screen by tapping the monitor screen.
Page 63: Button Name
Using the LifeVest® WCD system Screen buttons One way you interact with the LifeVest WCD is by using buttons on the screen. The following table describes the buttons you see most often. Other functions of the buttons are described in relevant sections in this manual.
Page 64 Change battery as soon as possible and recharge battery. See “Charging and changing batteries” on page 3-15. Battery may be defective: LifeVest cannot determine battery condition. Call ZOLL at 1-800-543-3267. Page 3-14...
Page 65: Charging And Changing Batteries
Do not dispose of or incinerate the batteries. The batteries contain lithium ion and must be disposed of properly by ZOLL. The LifeVest WCD includes two batteries. While one battery is in the monitor, keep the second battery in the charger.
Page 66 LifeVest® WCD Patient Manual Charger setup To set up the charger: 1 Place the charger so you can easily get to the side of the unit to insert and remove the battery. Make sure you can easily view the indicator lights. The charger should be placed in a safe, convenient location where you can leave it plugged into a standard power outlet that stays on all the time and is not controlled by a switch.
Page 67 It is recommended you change and recharge the battery every 24 hours. Note: Recharging the battery typically takes less than 6 hours but can take up to 16 – 18 hours. ZOLL recommends you establish a battery charging routine and do not allow a battery to drain completely of all charge before charging the battery.
Page 68 LifeVest® WCD Patient Manual 3 Read the battery status on the charger to confirm the battery status is either charging or charged. For details on how to read the charger indicator lights, see “Reading the charger indicator lights” on page 3-19. Page 3-18...
Page 69 15 There is a blinking, with seconds. problem, and audible alarm the battery Call ZOLL immediately at 1-800- cannot 543-3267. charge. Battery is fully Leave the battery in the charged, charger until you are ready to...
Page 70 LifeVest® WCD Patient Manual Indicator What it What to do means Power is being Make sure this indicator lights applied to the up when you plug in the charger. This charger. Blue, lit solid light will continue to stay lit when the other indicators light.
Page 71 If help is not available, and you expect power to be out for more than 24 hours, call ZOLL at 1-800-543-3267 to have spare batteries sent to you. When the power is restored, plug in your charger as normal.
Page 72: Assembling The Electrode Belt To The Garment
LifeVest® WCD Patient Manual Assembling the electrode belt to the garment To assemble the electrode belt to the garment: Lay the garment on a flat, solid surface with the colored hook and loop fasteners, snaps, and silver fabric pockets facing up. Lay the electrode belt with the silver sides of the therapy pads facing up.
Page 73 Using the LifeVest® WCD system Secure the silver fabric pockets with the snaps. Make sure the snaps are securely fastened. Position the vibration box on the garment in the position labeled 2. The vibration box side labeled 2 must face up. Page 3-23...
Page 74 LifeVest® WCD Patient Manual Secure the flap over the vibration box with the snaps. Make sure all snaps are securely fastened. Note: At least one cable should be coming out of each of the four sides of the flap. Insert the front therapy pad into the front pocket labeled 3.
Page 75 Using the LifeVest® WCD system Match the colors on the backs of the round electrodes to the colors of the fasteners on the garment. Attach the round electrodes to the garment. Page 3-25...
Page 76 LifeVest® WCD Patient Manual Verify your garment and electrode belt are assembled correctly. See the following figures. Page 3-26...
Page 77 Using the LifeVest® WCD system Inside of garment The inside of the garment faces your body when worn, with the silver fabric pockets against your skin. Outside of garment The outside faces away from your body when worn. The foam sides of the therapy pads face the back of the garment.
Page 78: Putting On The Assembled Electrode Belt And Garment
LifeVest® WCD Patient Manual Putting on the assembled electrode belt and garment Follow these instructions to put on the assembled garment, then make sure you are wearing it properly. The garment and electrode belt must be worn against your bare skin. 1 Before putting on the garment, remove all clothing and undergarments from your upper...
Page 79 Using the LifeVest® WCD system 4 Secure the garment by connecting the garment ends together in the front. Make sure the clips are fully inserted past the bump. 5 Check the position of the garment on your body and make sure it is not too high or too low.
Page 80 LifeVest® WCD Patient Manual 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. Positioned properly Too high Too low 6 Make sure that: The garment is not twisted, and the straps are flat against your skin.
Page 81 Using the LifeVest® WCD system Your garment should look like the figures below. 7 Connect the electrode belt to the monitor. See “Connecting the electrode belt to the monitor” on page 3-32. Page 3-31...
Page 82: Connecting The Electrode Belt To The Monitor
LifeVest® WCD Patient Manual Connecting the electrode belt to the monitor WARNING Make sure the electrode belt is properly connected to the monitor. If the electrode belt is not properly connected, it may disconnect and you will not be protected, which may result in serious injury or death. Ensure the electrode belt connector is aligned with the monitor receptacle before pushing it in.
Page 83: Placing The Monitor In Its Holster
Using the LifeVest® WCD system Placing the monitor in its holster The monitor should always be worn in its holster. To place the monitor in its holster: 1 Put on the LifeVest WCD. See “Wearing the LifeVest® WCD” on page 3-5. 2 Place the holster flat on a solid surface with the cut-out portion facing up.
Page 84 LifeVest® WCD Patient Manual 6 If necessary, place the electrode belt cable in the cable guides on the holster. 7 Wear the monitor in its holster. See “Wearing the monitor in its holster” on page 3-6. Page 3-34...
Page 85: Disconnecting The Electrode Belt From The Monitor
Using the LifeVest® WCD system Disconnecting the electrode belt from the monitor To disconnect the electrode belt: 1 Press the button on the electrode belt connector. 2 Pull the connector straight out of the monitor. Page 3-35...
Page 86: Removing The Lifevest® Wcd When You Shower Or Bathe
LifeVest® WCD Patient Manual Removing the LifeVest® WCD when you shower or bathe WARNING Do not put the monitor, electrode belt, battery, or charger in or near water. Water entering a component may damage it and/or cause the system to malfunction, which may result in serious injury or death. Inspect the LifeVest WCD for damage.
Page 87 Using the LifeVest® WCD system 2 Unfasten the garment by disconnecting the garment ends in the front. Make sure the clips are fully removed. 3 Remove the LifeVest WCD (garment and monitor in holster, if applicable) from your body. If you plan to change the garment, see “Disassembling the electrode belt and garment”...
Page 88: Disassembling The Electrode Belt And Garment
LifeVest® WCD Patient Manual Disassembling the electrode belt and garment To remove the electrode belt from the garment: Note: You can keep the electrode belt connected to monitor during this process. Remove the battery from the monitor. See “Removing the battery” on page 3-17.
Page 89 Using the LifeVest® WCD system Remove the vibration box from the garment. Unsnap the therapy pad pockets. Page 3-39...
Page 90 LifeVest® WCD Patient Manual Remove the therapy pads from their pockets. Do not pull on the cables. If necessary, clean the electrode belt and surfaces of the round electrodes and therapy pads. See “Cleaning the non-washable items” on page 3-43. Reassemble the garment and electrode belt as described in “Assembling the electrode belt to the garment”...
Page 91: Removing The Monitor From Its Holster
Using the LifeVest® WCD system Removing the monitor from its holster To remove the monitor from its holster: 1 Place the holster with the monitor in it flat on a solid surface with the screen of the monitor facing up. 2 If necessary, remove the electrode belt cable from the cable guides on the holster.
Page 92 LifeVest® WCD Patient Manual 5 Close the lid of the holster until it clicks. Page 3-42...
Page 93: Cleaning The Lifevest® Wcd System
Changes or modifications to this device not authorized by ZOLL could void the radio frequency energy (RF) compliance and negate your authority to operate the device. Do not disassemble the unit.
Page 94 LifeVest® WCD Patient Manual Review the following list on what to do and not do while cleaning the non-washables. Before cleaning, remove the battery from the monitor. For all components except the round electrodes, use a bleach cleaning wipe or a soft cloth sparingly dampened with soap and water.
Page 95: Garment Care
Using the LifeVest® WCD system Garment care WARNING Do not use chlorine bleach, bleach alternatives, fabric softener, dryer sheets, anti-static sprays, or detergents that include bleach or fabric softener additives when washing and drying the garment. Do not use the high heat setting when drying the garment. Using bleach or any of these other prohibited agents to wash and dry the garment and/or using high heat to dry the garment may damage it and cause the system to malfunction, which may result in serious injury or death.
Page 96 LifeVest® WCD Patient Manual garment. Do not use the high heat setting to dry the garment. 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).
Page 97 Using the LifeVest® WCD system Garment care symbols The symbols on the back of the garment tag indicate specific care instructions that must be followed for the garment. Laundering symbol. Indicates to machine wash on normal cycle with a maximum water temperature of 40°C (104°F). (ASTM D5489, 5.4) Laundering symbol.
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Page 99: 4: Understanding Alerts
4: Understanding alerts This section provides information about alerts you may receive.
Page 101: Types Of Alerts
Understanding alerts 4: Understanding alerts Types of alerts How you respond to an alert depends on the type of alert you get. There are three types of alerts: siren vibration gong Siren alert The siren alert is a high-pitched two-tone sound that means an abnormal heart rhythm has been detected.
Page 102 LifeVest® WCD Patient Manual Vibration alert If you feel a vibration on your back from the electrode belt's vibration box, you are being warned you are about to receive a siren alert. Follow the same instructions as for the siren alert in “Receiving a siren alert with a Patient Respond display message”...
Page 103: Receiving A Siren Alert With A Patient Respond Display Message
Understanding alerts Receiving a siren alert with a Patient Respond display message WARNING If you receive an alert sound and are awake, always press both response buttons to prevent receiving a treatment. If you fail to press both response buttons, you will get a treatment, which may result in serious injury or death.
Page 104 LifeVest® WCD Patient Manual If you are conscious, press and release both response buttons to stop the treatment from occurring. The siren alert stops and a voice prompts that the treatment has been stopped. The response buttons change from flashing to solid red once pressed and the vibration stops.
Page 105: After Receiving A Treatment
3 Tap OK to resume normal monitoring. 4 Check the display for any messages and take the action indicated. 5 Call ZOLL and arrange to get a new electrode belt. See “Responding to Call ZOLL message” on page 4-15. Page 4-5...
Page 106: Receiving A Siren Alert With An If Patient Is Not Responsive Display Message
LifeVest® WCD Patient Manual Receiving a siren alert with an If Patient is Not Responsive display message WARNING If you receive an alert sound and are awake, always press both response buttons to prevent receiving a treatment. If you fail to press both response buttons, you will get a treatment, which may result in serious injury or death.
Page 107 If the alert continues even after you press the response buttons, remove and replace the battery to reset the LifeVest WCD. If you continue to get this message, call ZOLL immediately at 1-800-543-3267. If you are not conscious, you will not be able to press the response buttons.
Page 108: Receiving A Gong Alert
LifeVest® WCD Patient Manual Receiving a gong alert If you get a gong alert, there is something that needs attention. The gong alert is accompanied by a message on the LifeVest WCD screen, and the monitor indicator light illuminates. When you hear the gong alert: 1.
Page 109: Responding To Electrode Belt Problem Message
Garment and electrode belt fit snugly, with the round electrodes pressing against the skin. You have cared for the LifeVest WCD system correctly. See “Cleaning the LifeVest® WCD system” on page 3-43. If problems continue, call ZOLL at 1-800-543-3267. Tap OK to return to normal operation. Page 4-9...
Page 110: Responding To Check Electrodes Message
Garment and electrode belt fit snugly, with the round electrodes pressing against the skin. Electrode belt cable is securely connected to the monitor. If you continue to get this message, call ZOLL immediately at 1-800- 543-3267. Page 4-10...
Page 111: Responding To Check Garment And Electrodes Message
4 Put a very small amount of unscented lotion on the metal surface of each round electrode, not on the therapy pads. 5 Put the garment on and connect the electrode belt to the monitor. 6 Insert the battery into the monitor. If problems continue, call ZOLL at 1-800-543-3267. Page 4-11...
Page 112: Responding To Therapy Pad Problem Message
Therapy pads are inserted correctly into their pockets, with the silver sides (with the green labels) facing the silver fabric pockets. See “Assembling the electrode belt to the garment” on page 3- If problems continue, call ZOLL at 1-800-543-3267. Tap OK to return to normal operation. Page 4-12...
Page 113: Responding To Add Gel To Therapy Pads Message
Understanding alerts Responding to Add Gel to Therapy Pads message After you receive a treatment to correct an abnormal heart rhythm, you may see this message telling you to add gel. Add Blue™ gel to the therapy pads or replace the electrode belt. To add Blue™...
Page 114 LifeVest® WCD Patient Manual 5 Put on the garment with electrode belt. See “Putting on the assembled electrode belt and garment” on page 3-28 for details. Ensure there is no Blue gel on the left side of your body between the front and rear therapy pads. Blue gel should not extend between the two areas.
Page 115: Responding To Call Zoll Message
2 Call your health care professional’s emergency number immediately to report your treatment. 3 Tap OK to resume normal monitoring. 4 Check the display for any messages and take the action indicated. 5 Call ZOLL and arrange to get a new electrode belt. Page 4-15...
Page 116: Responding To Too Much Gel, Clean Skin Message
LifeVest® WCD Patient Manual Responding to Too Much Gel, Clean Skin message After you receive a treatment or after you add Blue™ gel to the therapy pads, you may see this message telling you there is too much Blue gel on your skin. Remove excess Blue gel.
Page 117: Responding To Warning Message
Understanding alerts Responding to WARNING message System has a severe service problem. You cannot use the LifeVest WCD. You must write down the Service Code number and call ZOLL immediately at 1-800-543-3267. Page 4-17...
Page 118: Responding To Call For Service Message
System has a problem that requires service. Continue to use the system, and change and recharge battery as normal. You must write down the Service Code number and call ZOLL at 1-800- 543-3267. Tap OK to return to normal operation.
Page 119: Responding To Change Battery Message
Understanding alerts Responding to Change Battery message Battery needs to be changed. Change to a fully charged battery and place discharged battery into the charger. See “Charging and changing batteries” on page 3-15. Tap OK to return to normal operation. Responding to Electrode Belt Not Connected message Electrode belt is not connected to monitor.
Page 120: Responding To Do Not Remove Your Lifevest® System Message
LifeVest® WCD Patient Manual Responding to Do not remove your LifeVest® system message You have received a treatment. Call your health care professional’s emergency number immediately. Continue to wear your LifeVest WCD as normal. Leave the electrode belt connected to the monitor. If necessary, change the battery as you normally would.
Page 121: Responding To Press Response Buttons Message
Responding to Release Response Buttons message This message may appear at startup. You may be holding both response buttons instead of pressing and releasing them. Release both response buttons. If you are not holding both response buttons, call ZOLL immediately at 1-800-543-3267. Page 4-21...
Page 122: Responding To Remove Battery Message
If you continue to get this message with the battery fully inserted, call ZOLL immediately at 1-800-543-3267. Responding to Send Data message The monitor has data that has not been transmitted for some time.
Page 123: 5: Performing Activities
5: Performing activities This section provides information about using the activities options on the LifeVest WCD system including: Health survey activity WalkTest® activity...
Page 125 10 minutes. Continue wearing the LifeVest WCD throughout this process. During the next scheduled data upload, the LifeVest WCD sends your health survey information to the cloud where ZOLL’s remote data management system allows your health care professional to review the results.
Page 126: Taking The Health Survey
To take it another time, when ready, see “Taking a delayed health survey” on page 5-5. Taking the health survey ZOLL suggests you read through all the steps below before you answer the questions for the first time. Your health care professional decides which questions you are to answer.
Page 127 Performing activities Read the message on the screen, and perform any actions before continuing. Tap Next. The Health Survey screen displays. Read the message on the screen. Tap Next. The Health Survey Questions screen displays. Page 5-3...
Page 128 LifeVest® WCD Patient Manual Read the question. Note: You can tap the screen to hear the audio of the text. Select the answer that most closely describes your situation or the way you feel. If necessary, tap the arrows to select your answer.
Page 129: Taking A Delayed Health Survey
Performing activities Taking a delayed health survey Follow this procedure if you chose Later on the Health Survey Due screen. Note: Your screens might look slightly different than what is shown here. The procedure and buttons that you are to tap are the same. 1 On the monitor, tap Menu.
Page 130 LifeVest® WCD Patient Manual See “Taking the health survey ” on page 5-2 starting at step 2 for the rest of this process. Page 5-6...
Page 131: Walktest® Activity
Performing activities WalkTest® activity WARNING When you are performing a WalkTest® session, do not continue if the monitor broadcasts an alert sound. Stop and press and release both response buttons. If you continue, you may be at risk for a sudden cardiac arrest, which may result in serious injury or death.
Page 132 Stop when the monitor prompts you to. During the next scheduled data upload, the LifeVest WCD sends your WalkTest activity information to the cloud where ZOLL's remote data management system allows your health care professional to review the results.
Page 133 Performing activities If you have any questions, please contact your health care professional. To perform the WalkTest activity immediately when you receive the WalkTest® Activity Due message, see “Performing the WalkTest® activity” on page 5-10. To perform it another time, when ready, see “Performing a delayed WalkTest®...
Page 134: Performing The Walktest® Activity
LifeVest® WCD Patient Manual Performing the WalkTest® activity To perform a WalkTest activity: On the WalkTest Activity Due screen, tap Now. If you want to complete the WalkTest activity later, tap Later to return to normal operation. When ready, see “Performing a delayed WalkTest®...
Page 135 Performing activities Tap Next. The Pre Session Survey screen displays. Read the message on the screen. Tap Next. The WalkTest Survey screen displays. Read the question. Note: You can tap the screen to hear the audio of the text. Page 5-11...
Page 136 LifeVest® WCD Patient Manual Select the answer that most closely describes your situation or the way you feel. If necessary, use your finger to scroll through the answers. Tap Next. Continue to answer the questions in the WalkTest survey. Note: If you receive the Session Not Advised message, you cannot proceed with this...
Page 137 Performing activities 11 If you are ready to start the WalkTest session, tap Start. The WalkTest Session progress screen displays, and a voice will prompt you to start the WalkTest session. 12 Continue for 6 minutes. The progress bar shows how far you are in the WalkTest session.
Page 138 LifeVest® WCD Patient Manual 14 Read the message on the screen. Tap Next. The WalkTest Survey screen displays. 15 Read the question. Note: You can tap the screen to hear the audio of the text. 16 Select the answer that most closely describes your situation or the way you feel.
Page 139 Performing activities 19 When the WalkTest Activity Complete screen displays, the WalkTest session is complete. Tap Complete. Page 5-15...
Page 140: Performing A Delayed Walktest® Session
LifeVest® WCD Patient Manual Performing a delayed WalkTest® session Follow this procedure if you chose Later on the WalkTest® Activity Due screen. Note: Your screens might look slightly different than what is shown here. The procedure and buttons that you are to tap are the same. 1 On the monitor, tap Menu.
Page 141 Performing activities See “Performing the WalkTest® activity” on page 5-10 starting at step 2 for the rest of this process. Page 5-17...
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Page 143: 6: Using The Monitor's Functions
6: Using the monitor’s functions This section provides information about the other functions of the LifeVest WCD system including: Manually recording your heart rhythm Sending data to ZOLL Receiving updates to settings Configuring help screen audio options Enabling and disabling airplane mode...
Page 145 Using the monitor's functions 6: Using the monitor's functions Manually recording your heart rhythm At times, you may want to record your heart rhythm for your health care professional to review. Recording your heart rhythm should take about 15 seconds. Recordings include data 30 seconds prior to buttons being pressed plus 15 seconds of real-time data.
Page 146: Sending Data And Receiving Updates To Settings
There may be times you need to send data, such as activity information and heart rhythm data, for your health care professional to review. You may also need to receive an update to settings on your LifeVest WCD from ZOLL. If the Send Data message displays, you should send data.
Page 147: Reading Signal Strength Indicator
You may see this symbol signal. until the LifeVest WCD finds a signal. That is normal. If you continue to see this symbol, call ZOLL at 1-800- 543-3267. Page 6-3...
Page 148: Sending Data Manually
LifeVest® WCD Patient Manual Sending data manually To send data manually: 1 On the Send Data screen, tap Now. 2 The Connecting screen displays. 3 When the process starts, the monitor shows that data is being sent. 4 The monitor shows when the data transfer is complete.
Page 149 5 If the monitor is unable to send data, one of the Unable to Send Data screens displays. Tap Retry, and try again, or Tap OK. If you continue to have a problem sending data, call ZOLL at 1-800-543-3267. Page 6-5...
Page 150: Sending Delayed Data
LifeVest® WCD Patient Manual Sending delayed data Follow this procedure if you chose Later on the Send Data screen 1 On the monitor, tap Menu. If the screen is dark, press and release both response buttons to activate the screen. The Patient Menu screen displays.
Page 151 If the monitor is unable to send data, one of the Unable to Send Data screens displays. Tap Retry, and try again, or Tap OK. If you continue to have a problem sending data, call ZOLL at 1-800-543-3267. Page 6-7...
Page 152: Configuring Help Screen Audio Options
LifeVest® WCD Patient Manual Configuring help screen audio options You can change the mode and volume of the help screen audio. The mode sets how the help screen text is spoken. See “Changing the help screen audio mode” on page 6-11. You can change the volume of spoken messages.
Page 153: Changing The Help Screen Audio Volume
Using the monitor's functions Changing the help screen audio volume To change the help screen audio volume: 1 On the monitor, tap Menu. If the screen is dark, press and release both response buttons to activate the screen. The Patient Menu screen displays. 2 Tap Settings.
Page 154 LifeVest® WCD Patient Manual 4 Tap Voice Volume. The Voice Volume screen displays. 5 Tap the up or down arrows to select the desired volume level. Note: Level 3 is the loudest. 6 When the desired volume level is selected, tap Save. The volume level is saved.
Page 155: Changing The Help Screen Audio Mode
Using the monitor's functions Changing the help screen audio mode You can set the LifeVest WCD help screen audio to speak the help text when the help screen displays, when you tap the help screen, or not at all. To change the help screen audio mode: 1 On the monitor, tap Menu.
Page 156 LifeVest® WCD Patient Manual 4 Tap Voice Mode. The Voice Mode screen displays. 5 Tap the desired mode. Always: Audio automatically speaks the help text every time you enter a help screen. Tap to Speak: Audio speaks the help text when you tap the text area of the help screen.
Page 157: Changing The Lifevest® Wcd Audio Language
Using the monitor's functions Changing the LifeVest® WCD audio language Note: This functionality is only available if there is a secondary language available on your LifeVest WCD. If a secondary language is available on your LifeVest WCD, you will see the Translate button displayed in the upper left corner of help screens.
Page 158: Enabling And Disabling Airplane Mode
LifeVest® WCD Patient Manual Enabling and disabling airplane mode Airplane mode disables the LifeVest WCD from wirelessly transmitting data to avoid interfering with aircraft operation and other electrical equipment. Note: If you remove and reinsert the battery when airplane mode is enabled, upon startup airplane mode is automatically disabled.
Page 159 Using the monitor's functions 3 Tap Airplane Mode. The Airplane Mode screen displays. 4 Tap the toggle switch to enable airplane mode. The airplane mode indicator switches to on, and the airplane’s color changes to orange. 5 Tap Save. Page 6-15...
Page 160 LifeVest® WCD Patient Manual Airplane mode is enabled. No signals are transmitted from LifeVest WCD. You are still protected. The Home screen displays the airplane mode indicator when airplane mode is enabled. Page 6-16...
Page 161: Disabling Airplane Mode
Using the monitor's functions Disabling airplane mode Note: If airplane mode was previously enabled, the monitor will automatically disable airplane mode the next time you change the battery. To disable airplane mode manually on the LifeVest WCD: 1 On the monitor, tap Menu. If the screen is dark, press and release both response buttons to activate the screen.
Page 162 LifeVest® WCD Patient Manual 4 Tap the toggle switch to disable airplane mode. The airplane mode indicator switches to off, and the airplane’s color changes to gray. 5 Tap Save. Airplane mode is disabled. The device is able to transmit data again.
Page 163: Updating Lifevest® Wcd Settings Using Support Mode
Updating LifeVest® WCD settings using support mode The support mode feature is not currently active. ZOLL may reach out to you to update LifeVest WCD settings using support mode. Do not perform this process without assistance from ZOLL. Continue to wear the LifeVest WCD.
Page 164 The Support Mode screen displays. 5 When directed to by ZOLL, tap OK. The Support Mode screen displays. This screen displays the connection to ZOLL for the update. Once the connection is established, the Support PIN screen displays. Page 6-20...
Page 165 Using the monitor's functions 6 Read the number to ZOLL. ZOLL uses this number to access your LifeVest WCD. The update begins. Once the update process is complete, the Update Code screen displays. 7 Read the number to ZOLL. ZOLL uses this number to determine if the update was successful.
Page 166 LifeVest® WCD Patient Manual 8 When directed to by ZOLL, tap OK. The Patient Settings screen displays. 9 When directed to by ZOLL, tap the Close button on each screen until you return to the Home screen. Page 6-22...
Page 167: 7: Ending Use Of The Lifevest® Wcd
7: Ending use of the LifeVest® WCD system This section provides information about what to do when ending use of the LifeVest WCD system.
Page 169 Do not dispose of or incinerate the batteries. The batteries contain lithium ion and must be disposed of properly by ZOLL. Two weeks before you are finished with the LifeVest WCD, call ZOLL and arrange to return the LifeVest WCD system. In the US and Canada, call 1- 800-543-3267.
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Page 171: Troubleshooting And Faqs
8: Troubleshooting and FAQs This section provides information about troubleshooting the LifeVest WCD system and addresses frequently asked questions you may have while using the LifeVest WCD.
Page 173: 8: Troubleshooting
Problem Action You cannot find Continue to wear the LifeVest WCD. the problem Call ZOLL immediately at 1-800-543-3267 to replace a below defective monitor. System may require service. You cannot resolve the issue with the actions below Monitor will not Ensure the battery is fully inserted into the monitor.
Page 174 Call ZOLL immediately at 1-800-543-3267. battery will not stay inserted Cannot read Continue to wear the LifeVest WCD. display (shows Call ZOLL immediately at 1-800-543-3267 to replace a random letters defective monitor. on screen or is otherwise unreadable) Battery will not Unplug the charger and plug it back into the power outlet.
Page 175 “Charging and changing batteries” on page 3-15. buttons does not Press the response buttons more firmly. work If this problem persists, call ZOLL immediately at 1-800- 543-3267. Vibration alert is Remove and reinsert the battery into the monitor. See not felt during “Charging and changing batteries”...
Page 176: Frequently Asked Questions
What do I do if the garment feels too loose? Fasten the garment on the tightest clasp setting. If the garment is still too loose, call ZOLL at 1-800-543-3267. What do I do if the garment feels too tight? Fasten the garment on a looser clasp setting. If the garment is still too tight, call ZOLL at 1-800-543-3267.
Page 177 Ensure you will have power to charge a battery for 6 hours every 24 hours. If you are traveling by airplane, call ZOLL at 1-800-543-3267 to obtain a travel letter and enable airplane mode when necessary. See “Enabling and disabling airplane mode” on page 6-14. Also, review “Electromagnetic interference”...
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Page 179 Appendices This manual has the following appendices: Appendix A: Symbols glossary: describes all the graphics, symbols, and icons you may see on the LifeVest WCD labels and packaging. Appendix B: Monitor screen glossary: describes the graphics, indicators, and icons you may see on the monitor screen. Appendix C: Charger indicator glossary: describes the indicators on the charger.
Page 181: Appendix A: Symbols Glossary
Appendix A: Symbols glossary Appendix A: Symbols glossary This appendix includes all the graphics, symbols, and icons you may see on the LifeVest WCD labels and packaging. Where applicable, specific standards related to the use of a graphic, symbol, or icon are listed in parentheses. For details on specific monitor screens, see Appendix B: Monitor screen glossary.
Page 182 LifeVest® WCD Patient Manual Symbol Description Symbol to indicate the device was put on the European Market after August 13, 2005, and do not dispose of via the municipal waste collection system of any member state of the European Union. [In accordance with the Waste Electrical and Electronic Equipment (WEEE) Directive of the European Union.] Identifies a defibrillator proof type BF (body float) applied...
Page 183 Appendix A: Symbols glossary Symbol Description IP66/IP67 Immersion protection indicates the device is dust-tight, and has protection against powerful water jets and the effects of temporary immersion in water. (IEC 60529, 4) Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable...
Page 184 LifeVest® WCD Patient Manual Symbol Description Instructional icon. On the garment, this symbol indicates where to place the therapy pads in the garment. This symbol on the electrode belt indicates which side of the therapy pad should be next to your skin. Instructional icon.
Page 185 Appendix A: Symbols glossary Symbol Description Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
Page 186 LifeVest® WCD Patient Manual Symbol Description CE marking; indicates conformance with applicable European Directives and/or Regulations. Indicates the authorized representative in the European Community. Indicates the item is a medical device. Indicates the medical device manufacturer. (ISO 15223-1, 5.1.1) IP66/IP67 Immersion protection indicates the device is dust-tight, and has protection against powerful water jets and the effects of temporary immersion in water.
Page 187 Appendix A: Symbols glossary Symbol Description Safety sign. Indicates general warning sign. (ISO 7010, W001) Safety sign. Warns the medical personnel to open the garment before giving the patient conventional external defibrillation. (IEC 60601-1, 7.5) Laundering symbol. Indicates to machine wash on normal cycle with a maximum water temperature of 40°C (104°F).
Page 188: Packaging Symbols
LifeVest® WCD Patient Manual Symbol Description Instructional icon. Indicates where to insert the therapy pad in the side pocket of the garment. Size of the garment. Blue™ gel packets Symbol Description Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences.
Page 189 Appendix A: Symbols glossary Symbol Description Indicates the manufacturer’s serial number so that a specific medical device can be identified. (ISO 15223-1, 5.1.7) Indicates the manufacturer’s batch code so that the batch or lot can be identified. (ISO 15223-1, 5.1.5) Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that the current situation needs operator awareness or...
Page 190 LifeVest® WCD Patient Manual Symbol Description Indicates a medical device that can be broken or damaged if not handled carefully. (ISO 15223-1, 5.3.1) Indicates the range of humidity to which the medical device can be safely exposed. (ISO 15223-1, 5.3.8) Indicates the temperature limits to which the medical device can be safely exposed.
Page 191: Appendix B: Monitor Screen Glossary
Change battery as soon as possible and recharge battery. See “Charging and changing batteries” on page 3-15. Battery level unknown. Call ZOLL at 1-800-543-3267. Round electrode good signal. Normal, no action required. Round electrode poor signal. Check round electrode for cause of poor signal and fix problem.
Page 192: Buttons
LifeVest® WCD Patient Manual Indicator Description Front therapy pad off skin. Check therapy pad that is off skin and fix problem. Cellular signal strength. Strength is shown by the number of blue bars on the bottom right corner of certain screens. No cellular signal strength.
Page 193: Screens
Appendix B: Monitor screen glossary Graphics Graphic Description Airplane mode on. Displays on the Home screen when airplane mode is enabled. Monitor will not transmit data. See “Enabling and disabling airplane mode” on page 6-14. Monitoring mode. Animated on the Home screen to show that LifeVest WCD is in monitoring mode.
Page 194 LifeVest® WCD Patient Manual Screen Description Startup screen. Displays on the monitor screen after you insert a battery into the monitor. See “Daily routine and normal startup” on page 3-1. Startup screen. Displays on the monitor screen after you insert a battery into the monitor.
Page 195 Appendix B: Monitor screen glossary Activity screens Screen Description Health Survey Due. Indicates you are due to take the health survey. See “Health survey activity” on page 5-1. WalkTest® Activity Due. Indicates you are due to perform the WalkTest activity. “WalkTest®...
Page 196 LifeVest® WCD Patient Manual Screen Description WARNING message. You must write down the Service Code number and call ZOLL immediately at 1-800-543-3267. Call For Service message. The LifeVest WCD may require service. You must write down the Service Code number and call ZOLL at 1-800-543-3267.
Page 197 Appendix B: Monitor screen glossary Screen Description Electrode belt problem messages. Monitor is not receiving a clear signal from the round electrodes. The round electrodes as indicated with an X are probably not in good contact with skin. Electrode icons can be any combination of green, yellow, or red to show specific conditions.
Page 198 Blue gel is drying out. See “Responding to Add Gel to Therapy Pads message” on page 4-13. Call ZOLL message. Blue gel has been released. See “Responding to Call ZOLL message” on page 4-15. Too Much Gel, Clean Skin message. Too much Blue gel is on your skin.
Page 199 Remove Battery message. Indicates to remove the battery when you are not wearing the LifeVest WCD. See “Charging and changing batteries” on page 3-15. If you continue to get this message with the battery fully inserted, call ZOLL immediately at 1-800-543-3267. Page B-9...
Page 200 LifeVest® WCD Patient Manual Screen Description Send Data message. Indicates to send data to ZOLL. See “Sending data manually” on page 6-4. Page B-10...
Page 201: Appendix C: Charger Indicator Glossary
Battery cannot charge. This condition will be accompanied by Yellow, blinking, three beeps every 15 seconds. There is a with audible problem, and Call ZOLL immediately at 1-800-543- alarm the battery 3267. cannot charge. Battery is fully Leave the battery in the charger...
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Page 203: Appendix D: Technical Information
Appendix D: Technical Information Appendix D: Technical information Environmental conditions Operating environment Monitor, electrode belt, and 0°C to 50°C (32°F to 122°F) battery temperature range Note: The electrode belt, which is worn in direct contact with the skin, operates to a maximum of 43°C (109.4°F). In accordance with IEC 60601-1, 3rd Edition, Clause 11.1.2, the electrode belt does not generate any additional heat, and provided the skin does not exceed 43°C, the maximum surface temperature of the electrode belt will not exceed 43°C.
Page 204: Specifications
LifeVest® WCD Patient Manual Specifications Monitor dimensions 20.3 x 9.7 x 5.3 centimeters (8.0 x 3.8 x 2.1 inches) Monitor weight (with battery) 861 grams (1.9 pounds) Electrode belt and garment weight 540 grams to 563 grams (1.19 to 1.24 pounds) Dependent on garment size.
Page 205 Appendix D: Technical Information Wireless RF Information – Monitor Operational RF Frequency Bands US Frequency Bands LTE Band Name Uplink Frequency (MHz) Downlink Frequency (MHz) LTE Band 2 1850 – 1910 1930 – 1990 LTE Band 4 1710 – 1755 2110 – 2155 LTE Band 12 699 –...
Page 206 LifeVest® WCD Patient Manual Standards for FCC Wireless Certification: FCC CFR47 Part 2 – Frequency allocation and Radio Treaty Matters; General Rules and Regulations FCC CFR47 Part 24 - Personal Communications Services FCC CFR47 Part 27 - Miscellaneous Wireless Communications Services Standards for US SAR compliance of a body worn device FCC 47 CFR 2.1093 - Radiofrequency radiation exposure evaluation: portable devices IEEE Standard 1528-2013 IEE Recommended Practice for Determining Peak Spatial-...
Page 207: System Life Expectancy
Appendix D: Technical Information System life expectancy Monitor 3 years of monitoring and defibrillating service The LifeVest WCD is designed to be used continuously with infrequent defibrillation, which is defined in IEC 60601-2-4 as a defibrillator designed to endure less than 2,500 discharges. Battery At least 1 year (about 200 charge/discharge cycles) Charger...
Page 208: Auditory Alert Signal Information
LifeVest® WCD Patient Manual Auditory alert signal information This section contains details about the LifeVest WCD monitor and charger auditory alert signals. Note: Monitor sound pressure was measured with the monitor in its holster. Monitor gong alert Alert signal Description Type Priority Sound pressure (dB @ 1 m)
Page 209 Appendix D: Technical Information Monitor spoken alert Alert signal Description Type Priority Sound pressure (dB @ 1 Spoken Message "Bystanders, do not Technical High 73.6 dBA +/- 3dBA High interfere." Page D-7...
Page 210: Alert System Reminder Signals And Intervals
LifeVest® WCD Patient Manual Alert system reminder signals and intervals The chart below lists reminder signals, the nature of the alerts, and the intervals between reminder signals. Reminder signal condition Alert Interval Low battery Replace battery 15 minutes Post treatment notification Continue to wear 15 seconds (alert is repeated two times after treatment)
Page 211: Monitor Alerts, High Priority
Appendix D: Technical Information Alert delays The following charts list the delays from the onset of alert conditions until the alert signals are generated. Monitor alerts, high priority Alert condition Alert Alert signal Notes condition generation delay delay Device problem — loss of ability to none Immediate 2000 level service code...
Page 212: Monitor Alerts, Medium Priority
LifeVest® WCD Patient Manual Monitor alerts, medium priority Note: Alerts delayed if higher priority alert is active. Alert condition Alert Alert signal Notes condition generation delay delay Low battery ≤ 60 seconds Immediate Post treatment notification none Immediate Normal sinus rhythm to asystole <...
Page 213: Monitor Alerts, Low Priority
Appendix D: Technical Information Monitor alerts, low priority Alert condition Alert Alert signal Notes condition generation delay delay Electrode belt not connected – none Immediate level 1 Page D-11...
Page 214: Electromagnetic Compatibility
LifeVest® WCD Patient Manual Electromagnetic compatibility The LifeVest WCD was tested by an independent EMC test laboratory to demonstrate compliance to the emissions and immunity requirements of the applicable standards. Results are shown in “Classification for use” on page D-13. Classification of applied part The LifeVest system applied part classification is Type BF.
Page 215: Classification For Use
Appendix D: Technical Information Classification for use Type of protection Monitor, electrode belt: Internally powered against electric shock Charger: Class II Isolated Power supply that does not rely on protective earthing. Note: The combination of the charger and power supply form a Medical Electrical Equipment system (ME System).
Page 216: Fcc Regulatory Information
Changes or modifications to this device not authorized by ZOLL could void the radio frequency energy (RF) compliance and negate your authority to operate the device. Do not disassemble the unit.
Page 217 (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. ZOLL Medical Corporation, 121 Gamma Drive, Pittsburgh PA 15238 (USA) Contact 24 hours a day, 7 days a week: 1-800-543-3267 Page D-15...
Page 218: Aircraft Use
LifeVest® WCD Patient Manual Aircraft use The LifeVest WCD was tested to demonstrate compliance to the emissions and immunity requirements of the following standard: RTCA DO-160, Environmental Conditions and Test Procedures for Airborne Equipment, Section 20 (RF immunity) and Section 21 (RF emissions). Check with your airline for any special restrictions on using personal electronic equipment when making your flight reservations.
Page 219: Iec 60601-1-2 Specifications
Appendix D: Technical Information IEC 60601-1-2 specifications Electromagnetic emissions declaration Unless noted otherwise, all of the following information applies to versions of theLifeVest wearable cardioverter defibrillator 5100 using the compatible electrode belt and charger. Guidance and manufacturer's declaration — electromagnetic emissions The LifeVest WCD 5100 is intended for use in the electromagnetic environment specified below.
Page 220: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
LifeVest® WCD Patient Manual Electromagnetic immunity declaration Unless noted otherwise, all of the following information applies to versions of the LifeVest WCD 5100 and Charger Guidance and manufacturer's declaration — electromagnetic immunity The LifeVest WCD 5100 is intended for use in the electromagnetic environment specified below. The customer or the user of the LifeVest WCD 5100 should assure that it is used in such an environment.
Page 221 Appendix D: Technical Information Guidance and manufacturer's declaration — electromagnetic immunity The LifeVest WCD 5100 is intended for use in the electromagnetic environment specified below. The customer or the user of the LifeVest WCD 5100 should assure that it is used in such an environment.
Page 222 LifeVest® WCD Patient Manual Electromagnetic immunity declaration WARNING Portable and mobile RF communications equipment should be used no closer to any part of the LifeVest WCD, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. This information applies to the LifeVest WCD 5100 Charger Guidance and manufacturer's declaration —...
Page 223 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LifeVest 5100 is used exceeds the applicable RF compliance level above, the LifeVest 5100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LifeVest 5100.
Page 224 LifeVest® WCD Patient Manual This information applies to the LifeVest WCD 5100 Guidance and manufacturer's declaration — electromagnetic immunity The LifeVest WCD 5100 is intended for use in the electromagnetic environment specified below. The customer or the user of the LifeVest WCD 5100 should assure that it is used in such an environment.
Page 225 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the LifeVest 5100 is used exceeds the applicable RF compliance level above, the LifeVest 5100 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the LifeVest 5100.
Page 226: Test Specifications For Enclosure Port Immunity To Rf Wireless
LifeVest® WCD Patient Manual Test specifications for enclosure port immunity to RF wireless communications equipment This information applies to the LifeVest WCD 5100 Charger Test Band Service Modulati Maximu Distan Immuni Complian frequen ce (m) ty test ce level cy (MHz) power level (V/m)
Page 227 Appendix D: Technical Information Test Band Service Modulati Maximu Distan Immuni Complian frequen ce (m) ty test ce level cy (MHz) power level (V/m) (V/m) 2450 Bluetooth, Pulse WLAN, 802.11 modulatio 2570 b/g/n, n 217 Hz RFIF 2450, LTE Band 7 5240 WLAN 802.11 Pulse 5500...
Page 228: Test Specifications For Enclosure Port Immunity To Rf Wireless Communications Equipment
LifeVest® WCD Patient Manual Test specifications for enclosure port immunity to RF wireless communications equipment This information applies to the LifeVest WCD 5100 Test Band Service Modulati Maximu Distan Immuni Complian frequen ce (m) ty test ce level cy (MHz) power level (V/m)
Page 229 Appendix D: Technical Information Test Band Service Modulati Maximu Distan Immuni Complian frequen ce (m) ty test ce level cy (MHz) power level (V/m) (V/m) 2450 Bluetooth, Pulse WLAN, 802.11 modulatio 2570 b/g/n, n 217 Hz RFIF 2450, LTE Band 7 5240 WLAN 802.11 Pulse 5500...
Page 230: Test Specifications For Enclosure Port Immunity To Radio Frequency Identification Readers (Rfid
LifeVest® WCD Patient Manual Test specifications for enclosure port immunity to Radio Frequency Identification Readers (RFID) RFID Frequency Test Level Compliance Electromagnetic Environment Specification (rms) Level (rms) Guidance Recommended separation distance between any part of the LifeVest WCD 5100 or LifeVest WCD Charger ISO 14223 134.2 kHz...
Page 231: Separation Distances From Rf Equipment
= minimum separation distance in centimeters E = immunity test level = 40 V/m for LifeVest P = maximum power of the transmitter = 2 W for LifeVest 5100 Solving for d yields 21.2 cm (8.35 inches) As noted elsewhere in this document, the recommended separation distance is 27 cm (10.6 inches) as required by the US FDA.
Page 232: Recommended Separation Distances From Rf Equipment
LifeVest® WCD Patient Manual Recommended separation distances from RF equipment This information applies to the LifeVest WCD 5100 Charger Recommended separation distances between portable and mobile RF communications equipment and the LifeVest WCD 5100 Charger The LifeVest WCD 5100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 233 Appendix D: Technical Information This information applies to the LifeVest WCD 5100 Recommended separation distances between portable and mobile RF communications equipment and the LifeVest WCD 5100 The LifeVest WCD 5100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 234 LifeVest® WCD Patient Manual communications equipment could cause interference if it is inadvertently brought into patient areas. Note 5: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. *IEC 60601-2-4 requirement Page D-32...
Page 235: Appendix E: Software Licensing Statement
Appendix E: Software licensing statement Certain software components (referred to herein as “Open Source Components”) that are used by the LifeVest WCD are licensed by ZOLL Medical Corporation (referred to herein as “ZOLL Medical”) under various open source license agreements. As required by the terms of...
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Page 237 Index...
Page 239 Index Index adjust belt what to do 4-9 airplane mode 6-14 airplane mode indicator B-3 1 symbol A-4, A-7 airplane use D-16 alarms 4-1 alert 2 symbol A-4, A-4, A-7 add gel 4-13 adjust belt 4-9 check belt 4-11 3 symbol A-4, A-4, A-8, A-8 check round electrodes 4-10 delays D-9 ECG noise 4-9...
Page 240 LifeVest® WCD Patient Manual physiological battery 1-2, 1-3, 1-4 siren 4-3, 4-6 about 1-3, 1-4 treatment 4-5 alert 4-19, B-8 vibration 4-1 charge time 3-16 warnings 4-3, 4-6 fall out 8-2 responding to 4-3 help 8-2 siren 4-1, 4-3, 4-6 information 1-3, 1-4 technical inserting 3-9...
Page 241 Index Blue gel 4-5 using LifeVest WCD 1-16 leaking 2-3 washing 1-17, 3-45 Blue gel packets CE marking symbol A-4, A-6, A-9 symbols A-8 cell phone interference 1-25 blue light change battery charger 3-19 message 4-19, B-8 button changing ? 3-13, B-2 help screens audio 6-11 arrow 3-13, B-2 help screens audio mode 6-11...
Page 242 LifeVest® WCD Patient Manual clean skin cracks message 4-16 housing 2-3 cleaning 3-43, 8-5 therapy pads 2-3 battery 3-43, 8-5 charger 3-43, 8-5 daily use 2-1 components 3-43, 8-5 damaged electrode belt 3-43, 8-5 LifeVest WCD 2-2 electrodes 3-43, 8-5 damaged package symbol A-9 garment 3-45, 8-5 data...
Page 243 Index electrocardiogram storage D-1 recording 6-1 transportation D-1 electrode belt 1-2 vibration 1-21 about 1-5, 1-8 wireless interference 1-24 attach to garment 1-5, 1-6 environmental specifications D-17 box 1-5, 1-7, 1-8 essential performance 1-9 connecting 3-32 excess gel 4-16 connector 1-8 exclamation point symbol A-1, A-3, A-5, A- disassembly from garment 3-38 6, A-7, A-8, A-9...
Page 244 LifeVest® WCD Patient Manual proper wear 3-29 green sensor symbol 4-9 green stickers size 1-6 label symbol A-4, A-7 snaps 1-6, 1-6 green therapy pad indicator B-1, B-1 stretching 4-12, 8-4, 8-4 green therapy pad symbol 4-12 symbols A-6 tag A-8 tears 2-3 health survey 5-1 therapy pad 1-6...
Page 245 Index battery low (monitor) 3-14, B-1 change battery 4-19 cap B-3 check belt 4-11 ECG sensor question mark B-1 check round electrodes 4-10 ECG sensor X B-1 Do not remove your LifeVest system 4- green ECG sensor B-1 electrode belt 4-11 green therapy pad B-1, B-1 gong 4-8 monitoring mode B-3...
Page 246 LifeVest® WCD Patient Manual battery level 3-3 latch change battery 4-19, B-8 battery 3-17 check belt B-7 laundering check thearpy pads B-8 garment 3-45, 8-5 connect electrode belt 4-19 licensing statement E-1 patient name 3-3 life expectancy D-5 release response buttons 4-21 LifeVest WCD respond 4-21 about 1-1, 1-2, 8-4...
Page 247 Index physiological alert removal 3-36 call for help 4-6 sleep 3-11 siren 4-1, 4-3, 4-6 solid light 1-3 treatment 4-5 speaker 1-3 vibration 4-1 symbols A-1 warning 4-3, 4-6 touchscreen 1-3, 3-12 position of garment 3-28 wearing 3-6, 3-33 power outage 3-21 monitor wireless RF specifications D-3 problem solving 8-1 monitoring mode indicator B-3...
Page 248 LifeVest® WCD Patient Manual release response buttons sensor indicators B-1 message 4-21 sensor symbols 4-9 remote update 6-19 serial number symbol A-2, A-3, A-5, A-5, remove before bathing or showering 3-4 removing shock risk symbol A-3 battery 3-17, 3-17 showering 3-36 device 3-36 signal strength indicator 6-3 electrode belt 3-36...
Page 249 Index symbols catalogue number A-2, A-3, A-5, A-5, A- battery A-5 Blue gel packets A-8 caution A-1, A-3, A-5, A-6, A-7, A-8, A-9 charger A-4 CE A-4, A-6, A-9 electrode belt A-2 DC power A-6 garment A-6 do not dispose A-6 monitor A-1 do not use if package damaged A-9 packaging A-8...
Page 250 LifeVest® WCD Patient Manual using LIfeVest WCD monitor 1-3, 3-12 cautions 1-16 trademarks v training 1-27 warnings 1-11, 2-1 ventricular assist device training indicator B-3 warnings 1-11 transfer data 6-2 vibration transportation environment D-1 at startup 3-2 transportation temperature D-1 vibration alert 4-2 trash can 4-13 vibration box...
Page 251 1-14, 1-22, 1-24 website vi use of transducers 1-14, 1-22, 1-24 ZOLL-authorized representative 1-26, 1-27 using LifeVest WCD 1-14 ventricular assist device 1-11 WalkTest activity 1-15, 1-15, 5-7, 5-7, WalkTest session 1-15, 1-15, 5-7, 5-7,...
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