lifevest_system_wcd_3100_operator_s_manual_rev_fi.pdf
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LifeVest System
Model WCD 3100
Operator’s Manual
PN 20B0040 Rev FI
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LifeVest System WCD 3100 Operator’s Manual
Restricted sale
Federal (USA) law restricts this device to sale by or on the order of a physician.
Effectivity
This manual describes the LifeVest® WCD™ 3100 wearable defibrillator system with
software version 5.1 and up.
Disclaimer
Information, operation, specifications, and product appearance may change without
notice. Names and data used in examples are fictitious.
Trademarks
Lifecor, WCD, and LifeVest are trademarks or registered trademarks of ZOLL Lifecor
Corporation in the United States of America. All other product names mentioned herein
are the trademarks of their respective owners.
Copyright notice
Copyright 2006 Zoll Lifecor Corporation.
Patents
US patents: 6,681,003; 6,280,461; 6,253,099; 6,169,387; 6,097,982; 6,065,154;
5,944,669; 5,929,601; 5,741,306; 5,078,134; 4,928,690; others pending.
Software nonexclusive license
The LifeVest device includes certain software (“Software”). ZOLL Lifecor 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 Lifecor. You must keep the Software confidential.
Contact information
ZOLL Lifecor Corporation
121 Freeport Road
Pittsburgh, PA 15238-3495
USA
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Phone
Toll free (USA)
Fax
Web
412-826-2146
1-800-LIFECOR (1-800-543-3267)
412-826-9485
www.lifecor.com
1-800-LIFECOR
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Contents
Contents
1: Introduction .............................................................................................................................1-1
About this manual................................................................................................................... 1-1
What’s in this manual ............................................................................................................. 1-1
About the LifeVest system......................................................................................................1-2
Safety information................................................................................................................... 1-5
2: Patient fitting ...........................................................................................................................2-1
Before you start ...................................................................................................................... 2-1
Components of the LifeVest belt assembly ............................................................................ 2-1
How to measure the patient.................................................................................................... 2-2
How to assemble the electrode belt to the garment............................................................... 2-3
How to put the garment on the patient and finalize assembly................................................ 2-4
3: Patient training........................................................................................................................3-1
Main points to teach the patient ............................................................................................. 3-1
Summary of operating modes ................................................................................................ 3-3
Demonstrating the alarms ...................................................................................................... 3-4
4: Monitor setup for a new patient ............................................................................................4-1
About this section ................................................................................................................... 4-1
Menu structure........................................................................................................................ 4-1
How to put the monitor in setup mode.................................................................................... 4-2
How to set up a new patient ................................................................................................... 4-4
How to baseline a patient ....................................................................................................... 4-5
How to manually re-baseline a patient ................................................................................... 4-7
5: Data management ...................................................................................................................5-1
About LifeVest Network .......................................................................................................... 5-1
How to view patient data on LifeVest Network ....................................................................... 5-2
6: Clinical information ................................................................................................................6-1
Indications............................................................................................................................... 6-1
Contraindications.................................................................................................................... 6-1
Pacemaker interactions .......................................................................................................... 6-1
Recommendations for patients with pacemakers................................................................... 6-2
Recommendation for double counting of a normal rhythm .................................................... 6-2
Clinical studies........................................................................................................................ 6-3
Appendix A: Quick charts ......................................................................................................... A-1
Appendix B: Part Numbers ....................................................................................................... B-1
Appendix C: Symbols ................................................................................................................ C-1
Index
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Introduction
1: Introduction
About this manual
This manual:
y
is for operators of the LifeVest wearable defibrillator.
y
gives you instructions on how to fit patients, as well as instruct patients in the
use and care of the device.
y
supplements the patient manual, which gives patient instructions on the use
and care of the LifeVest device.
What’s in this manual
Here’s how to use this manual:
1-800-LIFECOR
y
The next few pages contain details about the LifeVest system, plus safety
information.
y
Patient fitting explains how to fit a patient and assemble the components of
the LifeVest belt.
y
Patient training gives guidelines for instructing the patient about the LifeVest
system and how to respond to alarms.
y
Monitor setup for a new patient covers the basic procedures and menus for
setting up the monitor before use by a new patient. (If you need to change
other settings, see the programming section of the Service Manual.)
y
Data management tells how to view patient data on the LifeVest Network
using a computer with Internet access.
y
Clinical information contains indications, contraindications, a summary of
the clinical studies, and other clinical details.
y
Appendixes include Quick charts, Part numbers, and Symbols. The quick
charts are particularly helpful as reminders of how to do things.
y
Use the Index at the back of the manual to find what you’re looking for
quickly.
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LifeVest System WCD 3100 Operator’s Manual
About the LifeVest system
The LifeVest is a cardioverter defibrillator worn by a patient at risk for sudden
cardiac arrest (SCA). It monitors the patient’s heart continuously and, if the
patient goes into a life-threatening arrhythmia, can deliver a shock treatment to
restore the patient’s heart to normal rhythm.
Two main components
The LifeVest system consists of two main components: (1) an electrode belt and
garment that surrounds the patient’s chest, and (2) a monitor that the patient
wears around the waist or from a shoulder strap.
Washable garments are available in sizes to suit most patients. The LifeVest
device’s electrodes are dry and non-adhesive to provide patient comfort.
The monitor weighs about 1.8 pounds, making it the lightest external defibrillator
available. The device contains pushbuttons and indicators for the user, as well as
a speaker for sounding alarms and voice prompts.
Treatment cycle less than a minute
When the device detects a treatable arrhythmia, an alarm sequence begins,
giving a conscious patient time to stop the treatment. This keeps inappropriate
arrhythmia detections from becoming inappropriate shocks, a key difference
between the wearable defibrillator and an implanted defibrillator.
If the patient holds the two “response” buttons at any time during the treatment
sequence, the alarms stop and no shocks will be delivered.
If the patient does not respond or releases the response buttons, the device
continues to give alarms and spoken warnings to bystanders that a treatment
shock is about to be delivered.
Gel within the electrodes is released just prior to delivering the treatment shock in
order to deliver the shock most efficiently.
The entire event, from arrhythmia detection to delivery of the shock treatment,
typically takes less than one minute.
If the arrhythmia continues after the first shock, up to 5 shocks may be given.
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Introduction
Treatment sequence
After identifying VF, there is a response time of 25 seconds (programmable up to
55 seconds) to allow the patient time to respond to the alarms, as shown below.
The lower threshold for VF identification can be set from 120 to 250 beats per
minute (bpm), with a default of 200 bpm.
If the system identifies VT, there is a response time of 60 seconds
(programmable up to 180 seconds). The lower threshold for VT identification can
be set from 120 to the VF threshold, with a default setting of 150 bpm.
Typical treatment sequence during ventricular fibrillation
The LifeVest device can deliver up to 5 defibrillating pulses during an arrhythmic
episode. The energy of the pulses can be programmed individually to between
75 and 150 joules (±5%), with a default setting of 150 joules.
ECG recording of events
The patient’s electrocardiogram (ECG) is recorded for all detected arrhythmias,
including before and after treatment. The patient can also manually record an
ECG at any time by pressing the response buttons on the device.
Patients transmit information from their devices by telephone to the LifeVest
Network. Physicians can then access their patient’s information from virtually any
computer with an Internet connection. LifeVest Network allows physicians to view
ECG recordings, patient use, ECC interference, and other device-related
information.
Biphasic waveform delivers efficient energy
The LifeVest device delivers its defibrillating energy in a biphasic truncated
exponential waveform, whereby the signal goes positive, then negative very
quickly. This type of waveform has been shown to be effective defibrillating at
lower energy levels.
The amplitude and width of the phases of the energy waveform are automatically
adjusted to deliver a precise energy amount regardless of the patient’s body
impedance.
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LifeVest System WCD 3100 Operator’s Manual
Reliable detection algorithm
The LifeVest has proved to be effective at detecting ventricular tachycardia (VT)
and ventricular fibrillation (VF). The detection algorithm was 100% sensitive for
VF and 95% sensitive for VT in bench testing. The algorithm uses the patient’s
baseline vectorcardiogram as a template for detecting changes in cardiac signal
morphology in addition to standard rate determination of arrhythmias.
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Introduction
Safety information
This information helps you safely operate the LifeVest system. Read and
understand these warnings, cautions, and symbols before using the device.
Terms used
WARNING: Alerts of possible injury or death caused by misuse of the device.
This includes device failure that could lead to the patient not being protected by
the device.
CAUTION: Alerts of a possible problem with the device. Such problems include
damage to the device or other property, or minor injury.
Rescue defibrillation
y
If the patient should require conventional defibrillation, a warning label on the
garment informs medical personnel to unfasten and lay open the garment,
thus removing the front therapy pad from the patient’s chest. If medical
personnel fail to do so, the LifeVest device may interfere with the
defibrillation, and the conventional defibrillator may damage the device.
Shock hazard
y
Do not attempt to open the monitor, battery, battery charger, or modem. This
may expose you to high voltage and damage the system.
To help ensure proper operation
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y
Use only the cables, batteries, and accessories specified in this manual. If
you use any other items, the system may not operate correctly.
y
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.
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Patient fitting
2: Patient fitting
This section explains how to fit a patient and assemble the components of the
LifeVest belt.
Before you start
y
Gather the electrode belt and garment.
y
Read through these procedures completely.
y
Familiarize yourself with the components and what they’re called.
y
Have a clean, flat area to lay out and assemble the components, such as a
table or counter. You might want to put a towel or cloth on the table to protect
the components as you assemble them.
Components of the LifeVest belt assembly
Electrode Belt
The electrode belt comes in one
size and fits any patient. The
parts of the electrode belt are
as follows:
1 Therapy pads
2 ECG electrodes
3 Vibration box
4 Cable and connector
Garment
The garment comes in a variety
of sizes to suit the patient.
In this chapter, you will
measure the patient to
determine what size garment to
use.
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LifeVest System WCD 3100 Operator’s Manual
How to measure the patient
Measure the patient to determine what size garment to use.
1
Have patient stand and remove all upper body clothing, including
undergarments.
2
Place a measuring tape around the patient’s chest, centered at the
xiphoid. Measure to the closest inch or centimeter.
3
Find the patient’s measurement in the chart below and get the size
garment indicated.
Chest measurement
inches
centimeters
Garment
10A0964-A0X
26-27
66-70
A01
28-30
71-78
A02
31-33
79-85
A03
34-36
86-93
A04
37-40
94-103
A05
41-45
104-116
A06
46-50
117-128
A07
51-56
129-142
A08
Note: The sizes in this chart are suggested sizes. You may vary from
the sizes indicated in order to suit patient.
Example: Patient measures 44 inches. Read the chart to locate this
measurement.
According to the
chart, patient needs
garment A06
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Patient fitting
How to assemble the electrode belt to the garment
Assemble the belt and garment as described in the Patient Manual, but do not
fasten the straps. The fully assembled electrode belt and garment should look
like the following figures.
Toward patient’s body
Make sure that this side faces toward the patient’s body.
Away from patient’s body
Make sure that this side faces away from patient’s body.
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LifeVest System WCD 3100 Operator’s Manual
How to put the garment on the patient and finalize assembly
Place the garment and belt assembly on the patient as follows.
1
All clothing and undergarments must be removed
before putting on the garment. All clothing,
including underwear, must be worn over the
device, not under it.
2
Apply unscented hand lotion or skin cream to the
four ECG electrodes.
3
Help the patient put on the garment. Connect the
ends of the garment together in the front.
4
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y
Make sure that the garment doesn’t get twisted
as the patient puts it on.
y
Tell the patient that the metal mesh pockets
must touch bare skin in order for a defibrillating
pulse to be delivered.
y
Female patients should be encouraged to wear
a bra over the garment. Make sure the metal
surface of the front therapy pad presses against
the patient’s body rather than the underside of
her left breast.
Position straps over the patient’s shoulders and
bring them under the patient’s arms around to the
patient’s back.
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Patient fitting
5
6
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Without stretching the strap, find the hole that lines
up with the button. Then stretch the strap slightly
and attached the button to the next hole.
y
Do not cut the strap.
y
Excess strap can be folded over and buttoned
again.
y
Repeat for each of the two long straps.
y
Adjust the garment for a good fit.
Bring the remaining strap down the front of the
patient’s chest and button it to the front of the
garment.
y
Do not cut the strap.
y
Excess strap can be folded over and buttoned
again.
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LifeVest System WCD 3100 Operator’s Manual
At left is the garment and belt assembly as viewed
from the patient’s front.
7
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Have the patient look in a mirror to make sure that:
y
Garment and belt assembly is being worn
correctly.
y
Garment is not twisted.
y
Electrodes and therapy pads are pressing
against bare skin.
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Patient training
3: Patient training
This section gives guidelines for instructing the patient about the LifeVest system
and how to respond to alarms.
We suggest that you:
1
Go over the main points below.
2
Explain the operating modes and alarms as described on page 3-3.
3
Demonstrate the types of alarms that can occur as described on page 3-4.
Main points to teach the patient
When you instruct the patient, stress the following points, explained below and
on the following page:
y
If you get a siren alarm, hold the response buttons.
y
If you get a gong alarm, read the message.
y
If you get shocked, call your doctor and send data.
y
Review the Patient Manual so that the patient is familiar with its contents and
where to find things.
If you get a siren alarm, hold the response buttons
y
The response buttons will light red when you are to press them so they will be
easy to find, even in the dark.
y
As long as you are able to, hold the response buttons to stop a treatment. As
long as you remain conscious and hold the response buttons, you are in no
danger of receiving a treatment shock.
y
If you lose consciousness, of course you will not be able to hold the response
buttons. In this case, and if the lethal heart rhythm continues, the device will
go through the treatment cycle and deliver a treatment shock.
y
It is very important that only you (the patient) hold the response buttons. This
is how the monitor knows whether or not you are conscious. DO NOT let
anyone else hold the response buttons for you.
If you get a gong alarm, read the message
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y
Read the display and do what it says to fix the problem. Check the Patient
Manual (section 5) for reminders about what to do for various messages.
y
Keep in mind that the monitor gives alarms, messages, and voice prompts to
guide you in what to do.
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LifeVest System WCD 3100 Operator’s Manual
If you have an event, call your doctor and send data
y
If you have any kind of cardiac event, even if you manage to stay conscious
and hold the response buttons, you should contact your physician and report
the incident.
y
Any cardiac event is recorded by the monitor so you can send the data later.
y
As soon as possible after any cardiac event, you should send data using the
modem.
Review the contents of the Patient Manual
Review how to:
y
change and charge the battery
y
change the garment
y
disassemble and reassemble the garment and electrode belt
y
send data using the modem
Also be sure to review the warnings and cautions located in the Patient Manual.
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Patient training
Summary of operating modes
As you instruct the patient, keep in mind that the device has basically three
operating modes:
Mode
Message
Normal
monitoring – no
alarms
Gong alarm
Various messages can
appear, for example:
What it means
What the patient needs to do
Monitor is operating
normally.
Nothing.
Patient needs to take
action.
Read monitor and do what it
says.
Check Patient Manual for more
information. See section 5, If you
get alarms.
Siren alarm
An arrhythmia is
being detected.
and
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Press and hold the response
buttons if conscious.
Check Patient Manual for more
information. See section 5, If you
get alarms.
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LifeVest System WCD 3100 Operator’s Manual
Demonstrating the alarms
Demonstrate the alarms to help the patient learn how to respond. Follow the
procedures below to:
y
Place the system in training mode, then
y
Simulate alarm conditions.
How to enter training mode
View the navigation buttons from the top of the monitor with the
display facing you.
1
Remove and reinsert the battery.
2
While the opening screen is displayed, hold the response
buttons and hold ◄ at the same time. Continue holding these
buttons until the screen changes.
This screen may be displayed for more than 10 seconds.
3
Page 3-4
Press ▲ or ▼ to choose a language, then press ►.
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Patient training
4
With PATIENT selected, press ►.
5
Press ▲ or ▼ to select TRAINING, then press ►.
6
Press ► to select OK, then press the response buttons.
7
Press the response buttons again.
8
The monitor is now in training mode, with these messages
alternating.
Press the response buttons to silence the gong alarm.
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The monitor is ready to demonstrate the noise and
arrhythmia alarms.
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LifeVest System WCD 3100 Operator’s Manual
Connect patient for training mode
Page 3-6
1
Outfit the patient with the electrode belt and garment.
2
Connect the electrode belt to the monitor.
3
Continue with the procedures on the next page.
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Patient training
How to demonstrate the arrhythmia alarms
1
With this screen displayed, press ▼.
The device runs through the alarm sequence that will occur if
an arrhythmia is detected:
2
y
Vibration alarm activates and response buttons light red.
y
Siren alarm sounds.
y
Display shows that an arrhythmia has been detected and
tells patient to press response buttons.
y
Voice prompts announce to bystanders that that patient is
going to be shocked.
Tell the patient to press and hold the response button during
the alarms.
The alarms stop as long as the patient holds the response
buttons.
Tell the patient to release the response buttons to show that
the alarm sequence resumes.
3
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To stop the arrhythmia demonstration, press ▼.
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LifeVest System WCD 3100 Operator’s Manual
How to demonstrate a noise alarm
1
With this screen displayed, press ▲.
2
Tell the patient what to do when the gong alarm sounds:
3
y
Read the display. This particular message states that
ECG signal is not clear. The ECG electrodes are not
sending a good signal to the monitor.
y
Take action to correct problem. In this case, adjust the
belt so that the ECG electrodes make better contact with
the skin.
y
Press response buttons if display so states. This stops
the gong alarm.
With a noise alarm, when you press the response buttons,
the monitor checks for an improvement in the ECG signal.
For the demonstration, the ADJUST BELT message returns.
4
After three cycles, the monitor displays this message.
When this happens, the patient is expected to check the belt
as described in the Patient Manual.
Pressing the response buttons does not make this message
go away.
5
Page 3-8
To stop the noise alarm demonstration, press ▲.
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Patient training
How to exit training mode
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1
Remove and reinsert the battery.
2
Press the response buttons as normal.
3
Monitor resumes normal operation.
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