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
Page vi
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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.

Introduction
Page 1-5
CAUTIONS
Any medical electrical equipment connected to the patient at the same
time as the LifeVest must be defibrillator proof, as shown by this symbol. If the
equipment is not defibrillator proof, the equipment may be damaged if the
LifeVest delivers a treatment shock. Disconnect any non-defibrillator proof
equipment from the patient while the patient is wearing the LifeVest.
Environment considerations related to noise and vibration
Certain environments or situations you encounter that are loud and have high
vibration could affect the LifeVest. A loud environment could make it difficult for
you to hear an alert to be able to appropriately respond. A high vibration
environment may result in an inappropriate treatment. For example, riding a
motorcycle may cause vibration and make it difficult for some patients to hear an
alert which may result in an inappropriate treatment.
If you encounter a loud, high vibration environment while wearing the LifeVest,
you should be attentive to your device to ensure you respond to any alerts. In the
unlikely event that vibration causes you to receive a siren alert, hold the
response buttons to prevent receiving a treatment and move away from the
source of vibration.
Known residual risks
A rash or skin irritation is a potential risk with LifeVest 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 provider.
A treatment shock from any defibrillator may cause skin burn. The LifeVest uses
Blue™ gel to reduce the chance of burn.
Intended use locations
The intended electromagnetic environments for the LifeVest 4000 are home,
small clinic, hospital, and transport.
Essential performance
The essential performance of the LifeVest is that it detects ventricular fibrillation
or ventricular tachycardia, then delivers a defibrillating shock. Unacceptable risks
include loss of detection and treatment functionality.

LifeVest 4000 Patient Manual
Page 1-6
Aircraft use
The LifeVest 4000 was tested to demonstrate compliance to the emissions and
immunity requirements of the following standard: RTCA DO-160G,
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.
Operator profile
As defined by IEC 60601-1-6, the operator profile is a summary of the mental,
physical, and demographic traits of the intended user population.
According to the IEC definition, the operator is defined as the person interacting
with the device. In the case of the LifeVest, there are three operators:
The patient wears and interacts with the LifeVest on a daily basis. The patient
profile appears below.
ZOLL authorized representatives fit patients with the equipment, and train
patients. The ZOLL authorized representative profile appears below.
Healthcare professionals prescribe the LifeVest for the patient. The
healthcare professional profile appears below.
Patient profile
The device is appropriate for patients who are at risk for sudden cardiac arrest
and meet the requirements described in the Patient Manual. The patient wears
the LifeVest at all times (except when showering or bathing), changes and
charges the batteries every 24 hours, responds to alarms, and presses the
response buttons if there is a treatment alarm in order to prevent inappropriate
shocks from occurring.
While a patient is using the device, the patient is expected to do minimal
maintenance, including periodically cleaning and inspecting the system, as
instructed in section 3, page 3-31.
The patient is not expected to do any service on the device. Only ZOLL is to
perform service on the device. The device is to be returned to ZOLL for service.
ZOLL authorized representative profile
ZOLL authorized representatives are ZOLL-trained professionals. Their job is to
program the equipment according to the patient's prescription, measure and fit
patients with the LifeVest equipment, train patients and family members, and
provide follow-up assistance if necessary.

Introduction
Page 1-7
ZOLL authorized representatives must have the mental and physical capabilities
to understand training given by ZOLL that covers programming the device,
measuring and fitting patients, and training patients in the daily use of the device.
Healthcare professional profile
Healthcare professionals evaluate and prescribe the patient. (Clinical information
is provided in the Operator’s Manual.) Healthcare professionals also monitor the
patient (LifeVest Network is described in the Operator’s Manual.) Healthcare
professionals can perform advanced programming of the device.
Patient training
It is essential that all patients receive training before wearing the LifeVest. This
training is given by ZOLL authorized representatives. These representatives
deliver the LifeVest training in the patient’s home or in a clinical setting.
Patient training consists of instructions for garment and electrode belt assembly
and disassembly; alarm response, including the use of the response buttons; and
how to change and recharge the batteries.
After completing the training, patients sign an agreement that documents receipt
of training in the use and care of the LifeVest.
In addition, phone support is available for patients by calling ZOLL or a ZOLL
representative.

LifeVest 4000 Patient Manual
Page 1-8
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.
Many common devices, including motors and electronic equipment, could
produce electromagnetic interference, also known as EMI, in the LifeVest device
that could affect its operation. The LifeVest device has been tested with a
number of common sources of electromagnetic disturbance, including cellular
telephones, airport security systems, and anti-theft detection systems. This
testing, along with clinical trial testing, has demonstrated that in everyday use the
LifeVest device is not normally affected by commonly encountered
electromagnetic disturbances.
Anti-theft detection systems, also known as electronic article surveillance
systems, are often used in department stores and libraries to prevent theft by
electronically sensing a special tag on a piece of merchandise when the tag
passes through a detector gate. In the USA, these detector gates are commonly
located near the doorways. In Europe, the detector gates may be positioned near
the checkout areas.
To prevent possible disturbance with the LifeVest device, follow these simple
guidelines when passing through airport security gates or anti-theft detection
gates:
Walk through the gate at a normal pace.
Avoid lingering near or leaning on the gate.
In some occupational and hospital environments, unusually high levels of
electromagnetic disturbance could be encountered. Examples of possible
sources of such disturbance include: Magnetic resonance (MR) imaging
equipment, communication equipment such as microwave transmitters, arc
welding equipment, high voltage transmission lines, electrocautery systems, and
electronic muscle stimulators. These environments should be avoided while
wearing the LifeVest device.
In the unlikely event that electromagnetic disturbance causes you to receive
arrhythmia alarms, hold the response buttons to prevent being shocked and
move away from the source of the disturbance. The LifeVest device should return
to normal monitoring mode in approximately 5 seconds.

Introduction
Page 1-9
Wireless 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.
The LifeVest can be susceptible to or cause wireless interference. Follow these
instructions:
Cell phone use – When using a cell phone, keep it at least 27 centimeters
(10.6 inches) away from the sensing electrodes (the round ones) on the
electrode belt. If you experience noise alarms while using a cell phone, move
the cell phone away from the electrode belt or stop using the cell phone.
Charger with touchscreen use – The charger with touchscreen contains a
cell phone for data transmissions. Keep the charger with touchscreen at least
27 centimeters (10.6 inches) away from your body to prevent interference. If
you experience interference near the charger with touchscreen, move away
from the charger. If you take the charger with touchscreen to a hospital, be
sure that the use of cell phones is permitted. If not, do not use the charger
with touchscreen while in the hospital. If you need to transmit data, use the
wired modem connection.
Hotspot use – The hotspot contains a cell phone for data transmissions.
Keep the hotspot at least 27 centimeters (10.6 inches) away from your body
to prevent interference. If you experience interference near the hotspot, move
away from the hotspot. If you take the hotspot to a hospital, be sure that the
use of cell phones is permitted. If not, do not use the hotspot while in the
hospital.
General precaution – If you experience any interference with the LifeVest
when in the presence of any other wireless device, move away from the
device or stop using the device that is causing the interference. If you
continue to have problems, call ZOLL

LifeVest 4000 Patient Manual
Page 1-10
FCC regulatory information
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
The monitor contains:
FCC-ID POOWML-C40
The charger with touchscreen may contain:
FCC-ID POOWML-C40
FCC-ID AU792U05E06800
To comply with FCC RF exposure requirements, a minimum separation distance
of 27 centimeters (10.6 inches) must be maintained between the user’s or
bystander's body and the antenna on the charger. With a separation distance of
27 centimeters (10.6 inches) or more, the charger produces RF exposure that is
well below the maximum permissible exposure limits.
Changes or modifications to this device not authorized by ZOLL could void the
RF compliance and negate your authority to operate the device.

Meet the LifeVest system
Page 2-1
2: Meet the LifeVest system
Components
Item Description
1 Monitor Main unit of LifeVest system. Connects to electrode belt. Monitors your heart rhythm and delivers
defibrillating treatment. See details on page 2-2.
2 Garment and
electrode belt
Fits around your body and connects to the monitor. Different style garments may be provided. See
details on page 2-3.
3 Charger with
touchscreen
Recharges the battery, communicates wirelessly with the monitor, and transmits data for doctor
review. See details on page 2-4.
4 Charger with
indicator lights
Recharges the battery. See details on page 2-5.
5 Holster Lets you carry around the monitor.

LifeVest 4000 Patient Manual
Page 2-2
Monitor
For details about operating and caring for the monitor, see section 3. For details
about responding to alarms, see section 5.
Item Description
1 Connector Connects to electrode belt.
2 Battery Powers the monitor. To recharge the battery, use the charger; see page 2-4.
3 Touchscreen Displays messages about device operation, and allows patient to interact with device. When you
turn the monitor upside-down, the display flips for reading by the patient who is wearing the
device.
During normal monitoring, most of the time the LifeVest displays a dark screen. To see the display,
press and release the response buttons.
For more on the monitor touchscreen, see page 2-6.
4 Response
buttons
Two buttons, located front and back, that light solid red when the device senses that your heart is
in a rapid life-threatening rhythm. You should, if conscious, press both response buttons to stop
from getting a defibrillating treatment. You can press and release the response buttons; you don’t
have to hold them continuously.

Meet the LifeVest system
Page 2-3
Garment and electrode belt
For details on assembling, wearing, and caring for the garment and electrode
belt, see section 4.
Item Description
1 Garment Worn under your clothing to hold the heart sensors and therapy pads against your chest.
2 Electrode belt Assembles to garment and contains heart sensors, vibration box, and therapy pads.
3 Heart sensors Sense your heart’s electrical signal for the monitor. Also called electrodes.
4 Connector Connects to the monitor.
5 Vibration box Notifies you that the device is preparing to give you a treatment.
6 Therapy pads Deliver a treatment to your heart.

LifeVest 4000 Patient Manual
Page 2-4
Charger
The charger with touchscreen charges the battery and transmits data. The
charger with indicator lights charges the battery and the hotspot transmits data.
The LifeVest system includes two batteries so that the monitor can run
continuously on battery power. For details on battery care, see section 3.
There are two types of chargers: One has a touchscreen and is described below.
The other has indicators and is described on the next page. You will receive one
or the other. They both perform the same function of charging the battery and
transmitting data.
Charger with touchscreen
Item Description
1 Touchscreen Displays messages about device operation and allows patient to interact with device. For more on
the charger touchscreen, see page 2-7.
2 Battery Shown charging in charger while other battery is in monitor.
3 Antenna Raise the antenna for best reception for transmitting data.
4 Power supply Plugs into a standard power outlet to provide power to the charger.
5 Power supply
connector
Connects the power supply to the charger.
6 Phone jacks Connects the charger to a phone line. Only use if instructed by ZOLL.
7 USB connector Do not use. Do not connect anything to this connector.
8 Ethernet
connection
Do not use. Do not connect anything to this connector.