ZOLL MTPCIE BW A User Manual

®
®
Model 5000
20
B0060 Rev
A - P
1
Contents
i
Restricted sale
Federal (USA) law restricts this device to sale by or on the order of a physician.
Effectivity
This manual describes the LifeVest 5000 wearable defibrillator system.
Disclaimer
Information, operation, specifications, and product appearance may change without notice. Names and
data used in examples are fictitious.
Trademarks
ZOLL, LifeVest, Blue and the color Blue are trademarks and/or registered trademarks of ZOLL Medical
Corporation in the United States and/or other countries.
Copyright notice
© 2016 ZOLL Medical Corporation. All rights reserved.
Patents
Patent: www.zoll.com/patents
Software nonexclusive license
The LifeVest device includes certain software (“Software). ZOLL grants you a nonexclusive license to use
the Software solely for diagnostic and treatment purposes as part of use of the LifeVest device. You are
prohibited from:
(
i) reproducing the Software;
(
ii) removing or destroying any proprietary markings, copyright notices or other legends which
are part of the Software;
(
iii) modifying or reverse engineering the Software; or
(
iv) removing the Software from the LifeVest device.
Title to the Software will remain at all times with ZOLL. You must keep the Software confidential.
LifeVest 5000 Patient Manual
ii
Contact information
ZOLL
Pittsburgh, PA 15238
USA
Phone toll free (USA and Canada
)
Phone outside USA
Fax
Web
1-800-543-3267
1-412-968-3333
1-412-826-9485
www.zoll.co
m
Contents
Contents
1: Introduction .............................................................................................................................1-1
About this manual ................................................................................................................................. 1-
1
About the LifeVest system and cardiac defibrillation ........................................................................... 1-
1
How the LifeVest works ........................................................................................................................ 1-
1
Safety information ................................................................................................................................ 1-
2
Environment considerations related to noise and vibration ................................................................ 1-
5
Intended use locations .......................................................................................................................... 1-
5
Essential performance........................................................................................................................... 1-
5
Aircraft use ............................................................................................................................................ 1-
5
Operator profile .................................................................................................................................... 1-
6
Patient profile ....................................................................................................................................... 1-
6
ZOLL authorized representative profile ................................................................................................ 1-
6
Patient training ...................................................................................................................................... 1-
6
Electromagnetic interference ............................................................................................................... 1-
7
Wireless interference ............................................................................................................................ 1-
8
FCC regulatory information ................................................................................................................... 1-
8
2: Meet the LifeVest 5000 system..................................................................................................2-1
Components .................................................................................................................. ........................ 2-
1
Garment and electrode belt .................................................................................................................. 2-
2
Monitor front view ........................................................................................................................... 2-
3
Monitor back view ............................................................................................................................ 2-
4
Monitor touchscreen ............................................................................................................................ 2-
5
Help screens .......................................................................................................................................... 2-
7
Charger .................................................................................................................................................. 2-
8
3: Using the LifeVest .....................................................................................................................3-1
Daily routine .......................................................................................................................................... 3-
1
Normal startup routine ......................................................................................................................... 3-
2
Battery care ........................................................................................................................................... 3-
3
Charger setup ........................................................................................................................................ 3-
4
Change and charge batteries daily ........................................................................................................ 3-
7
Record your heart rhythm (ECG) ........................................................................................................... 3-
8
Patient menu screen ............................................................................................................................. 3-
9
Voice options ....................................................................................................................................... 3-
10
Sending data manually ........................................................................................................................ 3-
11
Airplane mode ..................................................................................................................................... 3-
13
WiFi ..................................................................................................................................................... 3-
15
System information ............................................................................................................................. 3-
23
Support mode ..................................................................................................................................... 3-
24
Periodically clean and inspect the system .......................................................................................... 3-
26
What family members need to know .................................................................................................. 3-
27
When you are finished with the device .............................................................................................. 3-
28
4: Garment and electrode belt ......................................................................................................4-1
Assemble the garment and electrode belt ............................................................................................ 4-
1
Assembled garment and electrode belt ................................................................................................ 4-
3
Putting on the assembled garment and electrode belt ........................................................................ 4-
4
Connecting and disconnecting the electrode belt ................................................................................ 4-
7
iii
LifeVest 5000 Patient Manual
iv
Remove when showering and bathing .................................................................................................. 4-8
Disassembling the garment and electrode belt .................................................................................... 4-9
Laundering the garment ...................................................................................................................... 4-10
5: Responding to alerts .................................................................................................................5-1
Overview of alerts ................................................................................................................................. 5-1
Physiological alerts: vibration or siren sound ....................................................................................... 5-1
Siren with call for help message ............................................................................................................ 5-4
Technical alerts: gong sound ................................................................................................................. 5-5
Informative alerts: gong or high-pitched “train whistle” sound ........................................................... 5-6
6: Using the activities options .......................................................................................................6-1
Introduction to activities ....................................................................................................................... 6-1
Taking the health survey ....................................................................................................................... 6-2
Taking the health survey now ............................................................................................................... 6-3
Taking the WalkTest™ ........................................................................................................................... 6-7
Taking the WalkTest™ now ................................................................................................................... 6-9
Appendix A:
Symbols and Icons ..................................................................................................... A-1
Appendix B :
Software Licensing Statement ................................................................................... B-1
NO WARRANTY ..................................................................................................................................... B-1
Introduction
1-1
1:
Introduction
About this manual
This manual:
is for patients who are using the LifeVest wearable defibrillator.
gives you instructions on the use and care of the device.
is intended to supplement the training you received when you were fitted with the
LifeVest device.
About the LifeVest system and cardiac defibrillation
The LifeVest device continuously monitors your heart. If it detects a life threatening rhythm that
is too fast, the device delivers treatment to restore normal rhythm. If you are conscious, you can
prevent a treatment by using the response buttons when the device alerts you that a treatment
is coming.
How the LifeVest works
The round electrodes in the garment monitor your heart. Therefore, it is important to maintain
a snug fit across your chest. If the LifeVest detects a possible life threatening rhythm, the device
will first create a vibration in the middle of your back to warn you of a possible treatment. The
siren alert then occurs to inform you that the LifeVest is about to deliver a treatment, a
therapeutic dose of electrical energy, in an attempt to restore your normal heart rhythm.
If you are
conscious:
To prevent a treatment from occurring, press the
response buttons on the monitor. You may
release the buttons, but must repeat pressing
them each time the siren alert occurs. Pressing
the buttons tells the device that you are
conscious.
If you are
unconscious:
The response buttons will not be pressed, which
tells the LifeVest to prepare to deliver a
treatment. The monitor will then play an auditory
message to inform bystanders to not interfere
while the treatment is delivered.
LifeVest 5000 Patient Manual
1 - 2
Safety information
This information helps you safely operate the LifeVest device. Read and understand these
warnings, cautions, and symbols before using the device.
Conductive parts of electrodes and associated connectors should not contact other
conductive parts including earth.
If the charger or power supply makes unusual noises, sparking, starts to smoke, or
emits a burning smell, unplug it immediately from the wall outlet.
The only way to
completely remove power is by unplugging the AC power plug from the wall outlet.
Any medical electrical equipment connected to the patient at the same time as
the LifeVest must be defibrillator proof, as shown by this symbol.
If the equipment is
not defibrillator proof, the equipment may be damaged if the LifeVest delivers a
treatment. Disconnect any non-defibrillator proof equipment from the patient while the
patient is wearing the LifeVest.
Terms used
WARNING:
Warns of possible injury or death that can be caused by misuse of the device.
This includes device failure that could result in the inability of the device to
protect you.
CAUTION:
Advises of possible problems that include damage to the device or other
property, or minor injury.
WARNINGS
Do not use the LifeVest System until you receive training and understand the manual.
If you do
not understand how to use the system, you may damage it and/or cause the system to
malfunction.
Always wear the LifeVest when instructed to do so by a medical professional.
Make sure the
electrode belt is properly connected to the monitor. Inappropriate use of the LifeVest may damage
it and/or cause the system to malfunction.
Do not tamper, alter, drop or abuse any part of the system or labeling.
Altering the equipment in
any way may damage it and/or cause the system to malfunction. Do not disassemble the unit. A
shock hazard exists. Refer all servicing to qualified personnel.
Do not put the monitor, electrode belt, battery or charger in or near water.
Water entering the
device may damage it and/or cause the system to malfunction.
Introduction
1-3
WARNINGS
Always operate the system within the range of 0°C to 50°C (32°F to 122°F), up to 95% relative
humidity (non-condensing), and up to 10,000 feet in altitude.
Operating the device outside of this
range may damage it and/or cause the system to malfunction.
Do not use the device in the presence of flammable agents or in an oxygen enriched atmosphere.
This could present an explosion and fire hazard.
If you see Blue™ gel other than during a treatment, this may indicate a damaged electrode belt
and cause the system to malfunction.
Call ZOLL LifeVest immediately.
If the therapy pad Blue™ gel gets into your eyes, flush your eyes immediately with water and
contact your physician.
Your eyes may become irritated from the Blue™ gel.
The LifeVest is magnetic resonance (MRI) unsafe.
Do not use it in an MRI imaging
environment.
Do not stack or place the LifeVest next to other devices.
Doing so could expose the device to EMI
disturbance that may cause the system to malfunction.
Only the patient should press the response buttons.
The patient’s ability to press the response
buttons lets the device know whether or not the patient is conscious and is critical in deciding when
to give the patient a treatment. If anyone other than the patient presses the response buttons,
needed therapy may not be delivered, possibly resulting in serious injury or death.
Do not touch the patient while a treatment is being delivered.
Anyone touching the patient during
a treatment may be shocked.
Do not remove the battery, do not disconnect the electrode belt from the monitor, and do not
loosen the garment while the monitor is broadcasting alert sounds and/or voice prompts.
If the
battery is removed, the electrode belt disconnected from the monitor, or the garment is loosened,
needed therapy may not be delivered, possibly resulting in serious injury or death. CPR can be
performed as long as the monitor is not broadcasting alert sounds and/or voice prompts. If external
defibrillation is available, a decision can be made by a medical professional to remove the device
and monitor/treat the patient with external equipment.
Do not dispose of or incinerate the batteries.
The batteries contain lithium ion and must be
disposed of properly by ZOLL.
Do not force the connector.
Allow the connector to align before pushing it in. Forcing the
connector may damage it and cause the system to malfunction.
Do not use chlorine bleach, bleach alternatives, fabric softener, anti-static sprays or detergents
that include bleach or fabric softener additives when laundering the garment.
Using bleach or any
of these other prohibited agents to launder the garment may damage it and cause the system to
malfunction.
LifeVest 5000 Patient Manual
1 - 4
WARNINGS
If you get an alert sound and you are awake, always press the response buttons to prevent
receiving a treatment.
If you fail to press the response buttons, you will get a treatment.
If you receive a treatment while your heart is beating normally and you did not use the response
buttons, the treatment may cause an abnormal rhythm to occur.
There is a small possibility that
the abnormal heart rhythm may not be detected and death may result.
If you get the siren alert, stop walking and press the response buttons.
When performing the WalkTest™, do not continue walking if the monitor broadcasts an alert
sound.
Stop walking and press the response buttons as you normally would. If you continue
walking, you may place yourself at risk for a cardiac arrest, possibly resulting in serious injury or
death.
When performing the WalkTest™, do not continue walking if you experience symptoms such as
shortness of breath, chest pain, or other pain or discomfort.
Stop walking and sit or lie down. If
the symptoms continue or get worse, immediately call your doctor or emergency help. If you
continue walking or ignore the symptoms, you may place yourself at risk for a cardiac arrest or
other health problems, possibly resulting in serious injury or death.
Introduction
1-5
Indications for use
The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden
cardiac arrest and are not candidates for or refuse an implantable defibrillator.
The LifeVest system is indicated for patients under 18 years of age who are at risk for sudden
cardiac arrest and are not candidates for or refuse an implantable defibrillator. Patients must
have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75
kilograms (41.3 pounds) or greater.
Environment considerations related to noise and vibration
Certain environments or situations you encounter that are loud and have high vibration could
affect the LifeVest. A loud environment could make it difficult for you to hear an alert to be able
to appropriately respond. A high vibration environment may result in an inappropriate
treatment. For example, riding a motorcycle or using some lawnmowers may cause vibration
and make it difficult for some patients to hear an alert which may result in an inappropriate
treatment.
If you encounter a loud, high vibration environment while wearing the LifeVest, you should be
attentive to your device to ensure you respond to any alerts. In the unlikely event that vibration
causes you to receive a siren alert, press the response buttons to prevent receiving a treatment
and move away from the source of vibration.
Intended use locations
The intended electromagnetic environments for the LifeVest 5000 wearable defibrillator are
home, small clinic, hospital, and transport.
Essential performance
The essential performance of the LifeVest is that it detects ventricular fibrillation or ventricular
tachycardia, then delivers a treatment. Unacceptable risks include loss of detection and
treatment functionality.
Aircraft use
The LifeVest 5000 was tested to demonstrate compliance to the emissions and immunity
requirements of the following standard: RTCA DO-160F, Environmental Conditions and Test
Procedures for Airborne Equipment, Section 20 (RF immunity) and Section 21 (RF emissions).
Check with the airline for any special restrictions on using personal electronic equipment when
making flight reservations.
The Airplane mode feature disables the LV5000 from communicating wirelessly. Use this option
when on an airplane or in any environment where cellular phone use is prohibited.
LifeVest 5000 Patient Manual
1 - 6
Operator profile
As defined by IEC 60601-1-6, the operator profile is a summary of the mental, physical, and
demographic traits of the intended user population.
According to the IEC definition, the operator is defined as the person interacting with the device.
In the case of the LifeVest, there are two operators:
The patient wears and interacts with the LifeVest on a daily basis. The patient profile
appears below.
ZOLL authorized representatives fit patients with the equipment, and train patients. The
ZOLL authorized representative profile appears below.
Patient profile
The device is appropriate for patients who are at risk for sudden cardiac arrest and meet the
requirements described in the Patient Manual.
ZOLL authorized representative profile
ZOLL authorized representatives are ZOLL-trained professionals. Their job is to program the
equipment according to the patient’s prescription, measure and fit patients with the LifeVest
equipment, train patients and family members, and provide follow-up assistance if necessary.
ZOLL authorized representatives must have the mental and physical capabilities to understand
training given by ZOLL that covers programming the device, measuring and fitting patients, and
training patients in the daily use of the device.
Patient training
It is essential that all patients receive training before wearing the LifeVest. This training is given
by ZOLL authorized representatives. These representatives deliver the LifeVest training in the
patient’s home or in a clinical setting.
Patient training consists of instructions for garment and electrode belt assembly and
disassembly; alert response, including the use of the response buttons; and how to change and
recharge the batteries.
After completing the training, patients sign an agreement that documents receipt of training in
the use and care of the LifeVest.
In addition, phone support is available for patients by calling ZOLL or a ZOLL representative. See
page ii, for the ZOLL phone support number.
Introduction
1-7
Electromagnetic interference
Many common devices, including motors and electronic equipment, could produce
electromagnetic interference, also known as EMI, in the LifeVest device that could affect its
operation. The LifeVest device has been tested with a number of common sources of
electromagnetic disturbance, including cellular telephones, airport security systems, and anti-
theft detection systems. This testing, along with clinical trial testing, has demonstrated that in
everyday use the LifeVest device is not normally affected by commonly encountered
electromagnetic disturbances.
Anti-theft detection systems, also known as electronic article surveillance systems, are often
used in department stores and libraries to prevent theft by electronically sensing a special tag
on a piece of merchandise when the tag passes through a detector gate. In the USA, these
detector gates are commonly located near the doorways. In Europe, the detector gates may be
positioned near the checkout areas.
To prevent possible disturbance with the LifeVest device, follow these simple guidelines when
passing through airport security gates or anti-theft detection gates:
Walk through the gate at a normal pace.
Avoid lingering near or leaning on the gate.
In some occupational and hospital environments, unusually high levels of electromagnetic
disturbance could be encountered. Examples of possible sources of such disturbance include:
Magnetic resonance (MR) imaging equipment, communication equipment such as microwave
transmitters, arc welding equipment, high voltage transmission lines, electrocautery systems,
and electronic muscle stimulators. These environments should be avoided while wearing the
LifeVest device.
In the unlikely event that electromagnetic disturbance causes you to receive arrhythmia alerts,
press the response buttons to prevent being shocked and move away from the source of the
disturbance. The LifeVest device should return to normal monitoring mode in approximately 5
seconds.
LifeVest 5000 Patient Manual
1 - 8
Wireless interference
The LifeVest can be susceptible to or cause wireless interference. Follow these instructions:
Cell phone use
– When using a cell phone, keep it at least 10.6 inches (27
centimeters) away from the round electrodes on the electrode belt. If you
experience noise alerts while using a cell phone, move the cell phone away from
the electrode belt or stop using the cell phone.
Charger use
– The charger contains a cellular device for data transmissions. Keep
the charger at least 10.6 inches (27 centimeters) away from your body to
prevent interference. If you experience noise alerts while using the charger,
move away from the charger. If you take the charger to a hospital, be sure that
the use of cellular devices is permitted. If not, do not use the charger while in the
hospital. If you need to transmit data, use your in-home or supported open WiFi
network.
General precaution
– If you experience any interference with the LifeVest when
in the presence of any other wireless device, move away from the device or stop
using the other device. If you continue to have problems, call ZOLL.
FCC regulatory information
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
The monitor contains FCC-ID: W56MTPCIE-BW-A.
Refer to charger label for FCC ID.
Changes or modifications to this device not authorized by ZOLL could void the RF compliance
and negate your authority to operate the device.
The available scientific evidence does not show that any health problems are associated with
using low power wireless devices. There is no proof, however, that these low power wireless
devices are absolutely safe. Low power Wireless devices emit low levels of radio frequency
energy (RF) in the microwave range while being used. Whereas high levels of RF can produce
health effects (by heating tissue), exposure of low-level RF that does not produce heating effects
causes no known adverse health effects. Many studies of low-level RF exposures have not found
any biological effects. Some studies have suggested that some biological effects might occur, but
such findings have not been confirmed by additional research. The LV5000 has been tested and
found to comply with FCC radiation exposure limits set forth for an uncontrolled environment
and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement C to OET65. The
maximum SAR levels tested for the LV5000 has been shown to be 0.133 W/kg at Body.
Meet the LifeVest 5000 System
2-1
2:
Meet the LifeVest 5000 system
Components
Item
Description
Garment and
electrode belt
The garment fits around your body and the electrode belt connects to
the monitor. The electrode belt contains the therapy pads, round
electrodes and the vibration box. See details on page 2-2.
Monitor
Connects to the electrode belt. Monitors your heart rhythm and
initiates a treatment. See details on page 2-3 and 2-4.
A strap is attached to the monitor for easy mobility while wearing the
device.
Charger and
battery
Recharges the battery, communicates wirelessly with the monitor,
and transmits data for prescriber review. The LifeVest system includes
two batteries so that the monitor can run continuously on battery
power. See details on page 2-8 and 2-9.
2 1 3
Meet the LifeVest 5000 System
2-3
Monitor front view
Item
Description
Response
buttons
Two buttons, located on the front and back of the monitor, that light solid red
when the device senses that your heart has a life threatening, irregular
rhythm. If you are conscious, press both response buttons to stop the LifeVest
from delivering a treatment. You can press and release the response buttons;
you don’t have to hold them continuously.
Speaker
Audible voice prompts and alerts.
Status
indicator
lights
Indicate system status.
Green: On solid during normal operation. Off during gong or siren alerts.
Yellow: Flashes during a gong alert to tell you that something requires your
attention. Check monitor screen for any instructions.
Connector
Connection site for the electrode belt cable.
Strap
attachment
Two strap attachment areas on either side of the monitor. The strap is
adjustable to give you two options to comfortably wear the system. For
options on how to wear, see section 3.
Touchscreen
Displays messages about device operation, and allows you to interact by touch
with the device. When the monitor is held upside down, the display flips so
that you can read the screen.
Most of the time during normal monitoring, the touchscreen is dark. To view
the display on the screen, press the response buttons.
For details, see page 2-5.
1
2
3 4
6
5
LifeVest 5000 Patient Manual
2 - 4
Monitor back view
Item
Description
Battery
placement area
Location of battery placement in the monitor.
Battery
Powers the monitor. To recharge the battery, use the charger; see
page 2-8.
Battery release
button
Press to remove the battery from the monitor.
1 2
3
Meet the LifeVest 5000 System
2-5
Monitor touchscreen
Shown on the following page is an example of the monitor screen during normal monitoring.
Not all of the symbols, controls, and indicators shown in this example will appear all of the time.
Some symbols are shown only at certain times.
As situations change, the screen will change to advise you and suggest an action to take. Screens
that require you to take some action will have a help screen associated with them. For more on
help screens, see page 2-7.
Most of the time the monitor display screen is darkened to conserve battery power. If you wish
to view the Home screen or complete an action while wearing the LifeVest, press the response
buttons.
For a complete description of how to use the touchscreen in the daily use of the LifeVest, see
section 3.
LifeVest 5000 Patient Manual
2 - 6
Item
Description
Patient name
Displays your name so you know this device was programmed for you.
Menu button
Tap to display the Patient Menu, where you can select various options. See
details in section 3.
Electrode belt
status
Round electrodes are connected to the patient and are in normal
monitoring mode.
Belt is not connect
ed. See details in section 5.
Battery status
Shows amount of charge remaining in battery.
Green displays the remaining charge level.
Yellow indicates that the battery needs to be changed. Call ZOLL
for a replacement.
Red indicates a depleted charge.
Airplane mode
Airplane mode is on. For details, see section 3.
Recording heart
rhythm
Indicates that your heart rhythm is being recorded for your prescriber to
revi
ew, see section 3.
Meet the LifeVest 5000 System
2-7
Help screens
For any screen on the monitor that has a question mark icon in the lower right corner, you
can tap that icon and see a help screen.
Shown below is an example of a help screen.
Note:
Not all screens will have a help button. This button also appears in different colors such
as
on response button screens where the help button
is
blue
.
Item
Description
Help message
Brief message telling you what to do based on the present condition.
Touch to speak
If the speak option is enabled, touch the message area of the screen to hear the
help message. The message will be spoken in the language displayed. The area to
tap is shown by the dashed line in the example above; the dashed line will not be
visible on screen. To enable this feature, see section 3.
X button
Tap to close the screen.
Translation
button
O
nly appears if more than one language is programmed.
LifeVest 5000 Patient Manual
2 - 8
Charger
The charger recharges the battery and communicates wirelessly with the monitor.
The LifeVest system includes two batteries so that the monitor can run continuously on battery
power. For details on battery care, see section 3.
Item
Description
Power supply
Plugs into a standard power outlet to provide power to the charger.
For the charger power supply, any 60601-1 or 60950-1 approved
power supply providing an output of 18 VDC at 1.67 Amps (min) with
a CUI PPM-2-35135-SG connector, see Charger setup in section 3 for
details
.
Battery status
indicators
Indicate charger status. See details on page 2-9.
Battery
Powers the monitor. To recharge the battery, use the charger.
Power supply
connection area
Connects the power supply to the charger.
1 2
3
4
Meet the LifeVest 5000 System
2-9
Battery charger indicators
The battery charger indicators are located on the top of the charger. These indicate the charger
status. For details, see section 3.
Icon
Description
Power
Charger is connected to a power source.
Charging
Battery is currently being charged. Light blinks until fully charged
and then turns off.
Charge complete
Battery has full power.
Battery fault
Charger communication may not be functioning properly. Charger
can still be used to charge battery. Solid light and a momentary
beeping sound occurs. Call ZOLL.
Charger fault
Problem with the charger. Light blinks and a beeping sound occurs.
Call ZOLL.
2 1 3 4
5
LifeVest 5000 Patient Manual
2 - 10
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Using the LifeVest 5000 System
3 - 1
3: Using the LifeVest
Daily routine
This is an overview of the steps involved in the daily use of the LifeVest. Some details are found
elsewhere in this manual.
1. Wear the assembled electrode belt and garment. For details on wearing the LifeVest,
see section 4.
2. Put a fully-charged battery into the monitor and follow the normal startup routine. See
page 3-2.
3. Change and recharge the battery every 24 hours. See page 3-3, Battery care.
4. Wear the monitor with the strap fastened to the two attachment areas on the monitor.
The strap is adjustable to give you two options to comfortably wear the system, either
around your waist or hanging over your shoulder like a purse.
5. Respond to any alerts. See section 5.
6. Remove the battery from the monitor and then completely remove the LifeVest from
your body when you shower or bathe. Do not reinsert the battery until you are wearing
the fully assembled device. See section 4.
7. Change and wash the garment every 1 or 2 days. Wash only the garment. Do not wash
the electrode belt, monitor, or any other accessories. Follow the instructions in section 4
for laundering the garment.
LifeVest 5000 Patient Manual
3 - 2
Normal startup routine
1. Remove the depleted battery from the monitor.
2. Insert a fully-charged battery into the monitor.
Make sure the battery is completely inserted.
3. Startup screen appears.
4. When you hear the gong and feel the vibration
on your back, press the response buttons.
If you do not hear the gong or feel the
vibration within 30 seconds, remove the
battery. Reinsert the battery and try again.
If the monitor still does not operate normally,
contact ZOLL.
5. The monitor displays your name and battery
level.
Make sure your name appears on the monitor.
If your name does not appear, contact ZOLL
immediately.
6. During normal monitoring, most of the time the
LifeVest monitor screen displays a dark screen
and the green status indicator is lit solid.
To see the display, press the response buttons.
Using the LifeVest 5000 System
3 - 3
Battery care
What you need to know
You have two batteries, so you can use one
while charging the other.
Change and recharge batteries every 24 hours.
Recharging the battery takes approximately 4 to
6
hours.
Place the charger in a safe place where you can
leave it plugged in. Keep the second battery in
the charger while you use the monitor.
Always have a battery in the charger, even when
fully cha
rged.
The battery and charger may get warm. This is normal. Place the charger in a well ventilated
place.
Use only the batteries and charger supplied with the LifeVest system.
Remove the battery from the monitor when not wearing the device (when showering, for
example). Always remove the battery first to ensure the device is not active when you are not
wearing it. A “whistle” alert will sound if the battery has been left in the monitor for over 20
minutes with the electrode belt disconnected.
In the event of a power outage
If there is a power interruption you need to take steps to keep your batteries charged.
Notify your electric company that you have a
medical device that needs power. If they believe
the power will be out for 24 hours or more seek
alternatives for powering the batteries, such as a
neighbor or family member not affected by the
outage.
Notify your local emergency medical services and
see if they can help.
Locate a source of backup power if possible, such as a generator. Plug the battery charger into
the backup power and charge the spare battery continuously. Change the batteries every 24
hours.
If help is not available, and you expect power to be out for more than 24 hours, contact ZOLL
immediately to have spare batteries sent to you.
When the power is restored, continue charging and changing batteries every 24 hours.
LifeVest 5000 Patient Manual
3 - 4
Charger setup
If the charger or power supply makes unusual noises, sparking, starts to smoke, or emits a burning
smell, unplug it immediately from the wall outlet.
The only way to completely remove power is by
unplugging the AC power plug from the wall outlet.
Note:
For the charger power supply, any 60601-1 or 60950-1 approved power supply providing
an output of 18 VDC at 1.67 Amps (min) with a CUI PPM-2-35135-SG connector as detailed
below may be used.
Connection
Designation
Inner Contact
+
V
Outer Ring
-
V
1. Place the charger in the room where you
sleep, on a nightstand or end table, near a
power outlet.
Place the charger so you can easily get to
the top of the unit to insert and remove the
battery.
The charger can actually be placed
anywhere in the house, but we recommend
the room where you sleep so it is
convenient to use every day.
2. Plug the power supply into the back of the
charger, then plug it into a standard power
outlet.
Make sure the outlet stays on all the time,
and is not controlled by a light switch.
Keep the charger plugged in at all times.
When you first plugin the charger, all of the
icons will blink three times and you will hear
a rapid, beeping sound.
When the charger is powered on, the blue
icon
remains on
.
Using the LifeVest 5000 System
3 - 5
3. Gently insert the spare battery into the
charger.
Orient the battery with its connector facing
into the base of the charger.
Push the battery in firmly.
It takes approximately 4 to 6 hours to
charge a battery.
Keep a battery in the charger at all times,
even when fully charged.
4. Look for a symbol along the left of the
charger’s display. These symbols indicate the
battery status.
The battery should be charged or
charging.
These symbols are explained in the next
section, Charger and battery status
indicators.
LifeVest 5000 Patient Manual
3 - 6
Charger and battery status indicators
Icon
What it means
What to do
1
Power
Power is on.
Plug the power supply into the back of
the charger, then plug it into a standard
power outlet. Make sure the outlet stays
on all the time, and is not controlled by a
light switch.
Always leave a battery in the charger,
even when the battery is fully charged.
2
Charging
Battery is charging.
Let the battery charge. This can take 4 to
hours.
6 3
Charge complete
Battery is fully charged,
ready for use in monitor.
Leave battery in the charger until ready to
exchange battery even when the battery
is fully charged.
4
Battery fault
Battery has a problem.
Call ZOLL for a replacement battery.
5 Charger fault
Charger has a problem,
and cannot charge the
battery.
Do not leave a battery in the charger.
Battery is not being charged.
Call ZOLL for a replacement charger.
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