LifeVest System WCD 3100 Operator’s Manual Rev FI

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:

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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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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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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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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

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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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At left is the garment and belt assembly as viewed from the patient’s front.

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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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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

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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.

9

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The monitor is ready to demonstrate the noise and arrhythmia alarms.

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