ZOLL LifeVest 4000 User manual

LifeVest ®
Model 4000
Patient Manual
®
PN 20B0047-EUK-Rev M
May 1, 2021

LifeVest 4000 Patient Manual
Page ii
Contents
1:Introduction ........................................................................................................................1-1
About the LifeVest system......................................................................................................1-1
About this manual...................................................................................................................1-1
What’s in this manual .............................................................................................................1-1
Safety information...................................................................................................................1-2
Environment considerations related to noise and vibration....................................................1-5
Known residual risks...............................................................................................................1-5
Intended use locations............................................................................................................1-5
Essential performance............................................................................................................1-5
Aircraft use..............................................................................................................................1-6
Operator profile.......................................................................................................................1-6
Patient training........................................................................................................................1-7
Electromagnetic interference..................................................................................................1-8
Wireless interference..............................................................................................................1-9
FCC regulatory information ..................................................................................................1-10
2:Meet the LifeVest system ..................................................................................................2-1
Components ...........................................................................................................................2-1
Monitor....................................................................................................................................2-2
Garment and electrode belt .................................................................................................... 2-3
Charger...................................................................................................................................2-4
Monitor touchscreen ...............................................................................................................2-6
Charger touchscreen ..............................................................................................................2-7
Help screens...........................................................................................................................2-8
3:Using the LifeVest..............................................................................................................3-1
Daily routine............................................................................................................................ 3-1
Normal startup routine ............................................................................................................3-3
Taking care of the batteries ....................................................................................................3-5
Charger setup and use, charger with touchscreen.................................................................3-8
Charger setup and use, charger with indicator lights ...........................................................3-13
Sending data manually .........................................................................................................3-16
How to read the signal strength symbols .............................................................................3-19
Monitor signal strength symbol.............................................................................................3-20
Cellular signal strength symbol.............................................................................................3-21
Recording your heart rhythm ................................................................................................ 3-22
Speak options.......................................................................................................................3-23
Airplane mode ......................................................................................................................3-25
System info screens .............................................................................................................3-27
Support mode .......................................................................................................................3-28
To enter support mode .........................................................................................................3-29
Periodically clean and inspect the system............................................................................ 3-32
What family members need to know ....................................................................................3-33
When you are finished with the device.................................................................................3-35
4:Assembling and putting on the garment .........................................................................4-1
About this chapter...................................................................................................................4-1
Assembling the electrode belt to garment .............................................................................. 4-1
Assembled electrode belt and garment.................................................................................. 4-6
Putting on the assembled electrode belt and garment...........................................................4-7
Connecting and disconnecting the electrode belt.................................................................4-11

Contents
Page iii
Removing when you shower or bathe ..................................................................................4-12
Disassembling the electrode belt and garment ....................................................................4-13
Laundering the garment .......................................................................................................4-15
5:Responding to alarms .......................................................................................................5-1
How this chapter is organized ................................................................................................ 5-1
Physiological alarms...............................................................................................................5-1
Siren with respond message ..................................................................................................5-2
If you get a treatment..............................................................................................................5-3
Siren with call for help message.............................................................................................5-4
Technical alarms ....................................................................................................................5-5
Informative alarms ..................................................................................................................5-7
Belt problem message..........................................................................................................5-13
Check electrodes message ..................................................................................................5-14
Check belt message .............................................................................................................5-15
Therapy pad problem message............................................................................................5-16
Add gel..................................................................................................................................5-19
Replace belt..........................................................................................................................5-20
Too much gel........................................................................................................................5-21
6:Using the activities options ..............................................................................................6-1
Introduction .............................................................................................................................6-1
Health survey option...............................................................................................................6-2
How to know if you are to take the health survey...................................................................6-3
Answering the health survey questions.................................................................................. 6-4
Taking the health survey later ................................................................................................6-7
Health survey messages ........................................................................................................6-9
Walk test option ....................................................................................................................6-10
Warnings specific to the walk test ........................................................................................ 6-12
How to know if you are to take the walk test ........................................................................ 6-13
Answering the pre-walk questions........................................................................................6-14
Taking the walking portion of the walk test...........................................................................6-17
Answering the post-walk questions ......................................................................................6-20
Taking the walk test later......................................................................................................6-23
Walk test messages .............................................................................................................6-25
Appendix A:Quick charts..................................................................................................... A-1
Appendix B:Glossary ........................................................................................................... B-1
Appendix C:Symbols ........................................................................................................... C-1
Appendix D:Software licensing statement......................................................................... D-1
Index

LifeVest 4000 Patient Manual
Page iv
Restricted sale
Federal (USA) law restricts this device to sale by or on the order of a physician.
Effectivity
This manual describes the LifeVest 4000 wearable defibrillator system.
Disclaimer
Information, operation, specifications, and product appearance may change without
notice. Names and data used in examples are fictitious.
Trademarks
ZOLL, LifeVest, and Blue are trademarks or registered trademarks of ZOLL Medical
Corporation in the United States of America. All other trademarks and registered
trademarks are property of their respective owners.
Copyright notice
© 2021 ZOLL Medical Corporation. All rights reserved.
Patents
Patent: www.zoll.com/patents
Software nonexclusive license
The LifeVest device includes certain software (“Software”). ZOLL grants you a
nonexclusive license to use the Software solely for diagnostic and treatment purposes as
part of use of the LifeVest device. You are prohibited from: (i) reproducing the Software;
(ii) removing or destroying any proprietary markings, copyright notices or other legends
which are part of the Software; (iii) modifying or reverse engineering the Software; or
(iv) removing the Software from the LifeVest device. Title to the Software will remain at all
times with ZOLL. You must keep the Software confidential.

Contents
Page v
Contact information
Manufacturer:
ZOLL
Pittsburgh, PA 15238
USA
Phone
Fax
Web
[phone]
[phone]
www.zoll.com
In the UK, contact:
Dot Medical Ltd.
Silk Point
Queens Avenue
Macclesfield
Cheshire
SK10 2BB
United Kingdom
Phone
Technical Support
Email
Web
01625 668811
01625 668811
[email protected]
www.dot-medical.com
In Spain, contact:
ZOLL CMS GmbH
Emil-Hoffmann-Str. 13
50996 Köln
Deutschland
Phone
Technical Support
Email
Web
900 998 427
900 998 426
[email protected]
www.lifevest.zoll.com

LifeVest 4000 Patient Manual
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Introduction
Page 1-1
1: Introduction
About the LifeVest system
The LifeVest device continuously monitors your heart. If it detects a life
threatening rhythm that is too fast, the device delivers treatment to restore
normal rhythm. If you are conscious, you can prevent a treatment by using the
response buttons when the device alerts you that a treatment is coming.
About this manual
This manual:
is for patients who are using the LifeVest wearable defibrillator.
gives you instructions on the use and care of the device.
is intended to supplement the training you received when you were fitted with
the LifeVest device.
What’s in this manual
Here’s how to use this manual:
The next few pages contain safety information, intended use locations,
essential performance, and electromagnetic compatibility guidance.
Meet the LifeVest system tells you about the components, what they’re
called, and basically how they work.
Using the LifeVest device suggests a daily routine, tells you how to use and
care for the device, and tells you what to tell your family members.
Assembling and putting on the garment goes into the specific details
about how to assemble the electrode belt to the garment, then how to put on
the assembled belt and garment. This section also covers connecting and
disconnecting the electrode belt, removing the garment when you shower or
bathe, as well as disassembling and laundering the garment.
Responding to alarms explains the types of alarms and tells you what to do
if you get an alarm.
Using the activities options covers options that can be prescribed by your
doctor while you’re wearing the LifeVest.
Appendixes include Quick charts, a Glossary, Symbols, and a Software
licensing statement. The quick charts are particularly helpful as reminders
of how to do things. The glossary defines terms and abbreviations. The list of
symbols defines icons on the components, in this manual, and on the
packaging.
Use the Index at the back of the manual to find what you’re looking for
quickly.

LifeVest 4000 Patient Manual
Page 1-2
Safety information
This information helps you safely operate the LifeVest device. Read and
understand these warnings, cautions, and symbols before using the device.
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.
Terms used
WARNING: Warns you of possible injury or death that can be caused by
misuse of the device. This includes device failure that could lead to you being not
protected by the device.
CAUTION: Advises you of a possible problem with the device. Such
problems include damage to the device or other property, or minor injury.
WARNINGS
Do not use the LifeVest system until you receive training and understand the
manual. If you do not understand how to use the system, you may damage it,
cause the system to malfunction, and/or cause injury or death.
Tell your medical professional about all of your medical conditions and current
treatments. Always wear the LifeVest when instructed to do so by a medical
professional. Inappropriate use of the LifeVest may damage it and/or cause the
system to malfunction. Ask your medical professional to explain any parts that
you do not understand.
Make sure the battery is fully inserted and latched into the monitor. If the battery
is not fully inserted and latched, it may disconnect and you will not be protected.
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.
Do not tamper with, alter, drop or abuse any part of the system or labeling. Do
not put fingers or foreign objects, such as paper clips or hair pins, into any
connectors or openings. Altering the equipment in any way may damage it
and/or cause the system to malfunction. Do not disassemble the unit. A shock
hazard exists. Refer all servicing to qualified personnel.
Do not put the monitor, electrode belt, battery or charger in or near water. Water
entering the device may damage it and/or cause the system to malfunction.

Introduction
Page 1-3
WARNINGS
Always operate the system within the range of 0°C to 50°C (32°F to 122°F), up
to 95% relative humidity (non-condensing), and up to 3,048 meters (10,000 feet)
in altitude. Operating the device outside of this range may damage it and/or
cause the system to malfunction.
Do not use the device in the presence of flammable agents or in an oxygen
enriched atmosphere. This could present an explosion and fire hazard.
If you see Blue gel other than during a treatment, this may indicate a damaged
electrode belt and cause the system to malfunction. Call your device provider
immediately.
If the therapy pad Blue gel gets into your eyes, flush your eyes immediately with
water and contact your physician. Your eyes may become irritated from the Blue
gel.
The LifeVest is magnetic resonance (MRI) unsafe. Do not use it in a MR
imaging environment.
Do not stack or place the LifeVest next to other devices. Doing so could expose
the device to EMI disturbance that may cause the system to malfunction.
Only the patient should press the response buttons. The patient’s ability to
press the response buttons lets the device know whether or not the patient is
conscious and is critical in deciding when to give the patient a shock. If anyone
other than the patient holds the response buttons, needed therapy may not be
delivered, possibly resulting in serious injury or death.
Do not touch the patient while a shock is being delivered. Anyone touching the
patient during a treatment may be shocked.
Do not remove the battery, do not disconnect the electrode belt from the
monitor, and do not loosen the garment while the monitor is broadcasting alert
sounds and/or voice prompts. If the battery is removed, the electrode belt
disconnected from the monitor, or the garment is loosened, needed therapy
may not be delivered, possibly resulting in serious injury or death. CPR can be
performed as long as the monitor is not broadcasting alerts sounds and/or voice
prompts. If external defibrillation is available, a decision can be made by a
medical professional to remove the device and monitor/treat the patient with
external equipment.
Do not dispose of or incinerate the batteries. The batteries contain lithium ion
and must be disposed of properly by ZOLL.
Do not force the connector. Allow the connector to align before pushing it in.
Forcing the connector may damage it and cause the system to malfunction.

LifeVest 4000 Patient Manual
Page 1-4
WARNINGS
Do not use chlorine bleach, bleach alternatives, fabric softener, anti-static
sprays or detergents that include bleach or fabric softener additives when
laundering the garment. Using bleach or any of these other prohibited agents to
launder the garment may damage it and cause the system to malfunction.
If you get an alert sound and you are awake, always hold the response buttons
to prevent receiving a treatment. If you fail to hold the response buttons, you will
get a treatment.
If you receive a treatment while your heart is beating normally and you did not
use the response buttons, the treatment may cause an abnormal rhythm to
occur. There is a small possibility that the abnormal heart rhythm may not be
detected and death may result.
When performing the walk test, do not continue walking if the monitor
broadcasts an alert sound stop walking and press the response buttons as you
normally would. If you continue walking, you may place yourself at risk for a
cardiac arrest, possibly resulting in serious injury or death.
When performing the walk test, do not continue walking if you experience
symptoms such as shortness of breath, chest pain, or other pain or discomfort.
Stop walking and sit or lie down. If the symptoms continue or get worse,
immediately call your doctor or emergency help. If you continue walking or
ignore the symptoms, you may place yourself at risk for a cardiac arrest or other
health problems, possibly resulting in serious injury or death.
Conductive parts of electrodes and associated connectors should not contact
other conductive parts including earth.
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.
CAUTIONS
If the charger or power supply makes unusual noises, sparking, starts to smoke,
or emits a burning smell, unplug it immediately from the wall outlet. The only
way to completely remove power is by unplugging the AC power plug from the
wall outlet. Place the charger so that the power plug is accessible in case you
need to unplug it.