Philips Blood Pressure Monitor M3860A User Manual

P O W E R T O S A V E

L I F E

H E A R T S T A R T F R 2 + D E F I B R I L L A T O R

I N S T R U C T I O N S F O R U S E

M3860A, M3861A

Edition 10

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HEARTST ART FR2+ DEFIBRILLATOR

Q U ICK R E F E R E N CE CAR D

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Intentionally left blank.

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HEARTSTART FR2+

M3860A, M3861A Defibrillator

I N ST R U CT I O N S F O R U S E

Edition 10

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Instructions for Use

Authorized EU Representative

Equipment specifications are subject to alteration

without notice. All changes will be in compliance

with regulations governing manufacture of

medical equipment.

Philips Medizinsysteme Boeblingen GmbH

Hewlett-Packard Strasse 2

71034 Boeblingen, Germany

(+49) 7031-14-5151

Printed in the U.S.A.

CAUTION

FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE

BY OR ON THE ORDER OF A PHYSICIAN.

Publication date: August 2003

Publication number: M3860-91900

Part number: 011120-0010

The HeartStart FR2+ is designed to be used only with Philips-

approved accessories. The HeartStart FR2+ may perform

improperly if non-approved accessories are used.

No part of this publication may be reproduced,

transmitted, transcribed, stored in a retrieval

system or translated into any human or computer

language in any form by any means without the

consent of the copyright holder.

Device Tracking

In the U.S.A., this device is subject to tracking requirements by

the manufacturer and distributors. If the defibrillator has been

sold, donated, lost, stolen, exported, or destroyed, notify Philips

Medical Systems or your distributor.

Unauthorized copying of this publication may not

only infringe copyright but also reduce the ability

of Philips Medical Systems to provide accurate

and up-to-date information to users and operators

alike.

Device Manufacturer

The HeartStart FR2+ Defibrillator is manufactured by Philips

Medical Systems, Seattle, Washington, USA.

Philips Medical Systems reserves the right to

make changes in specifications or to discontinue

any product at any time without notice or

obligation and will not be liable for any

consequences resulting from the use of this

publication.

M3860A/M3861A HEARTSTART FR2+

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Contents

1 Introduction to the HeartStart FR2+

What is the HeartStart FR2+? ................................................................. 1-1

When Is the HeartStart FR2+ Used? .................................................... 1-2

How Does the HeartStart FR2+ Work? ................................................ 1-2

How Is the HeartStart FR2+ Supplied? ................................................ 1-3

2 Preparing Your HeartStart FR2+ for Use

Overview ....................................................................................................... 2-1

Installing the Battery ................................................................................... 2-1

Setting the Clock ........................................................................................ 2-3

Running the Battery Insertion Selftest .................................................... 2-4

Placing and Securing the HeartStart FR2+ .......................................... 2-5

3 Using Your HeartStart FR2+

Overview ....................................................................................................... 3-1

Step 1: Preparation .................................................................................... 3-2

Step 2: ECG Analysis and Monitoring ................................................... 3-3

Step 3: Shock Delivery .............................................................................. 3-4

ECG Display for Ongoing Observation ................................................. 3-5

4 Maintaining, Testing, and Troubleshooting

Your HeartStart FR2+

Overview ....................................................................................................... 4-1

Maintenance ................................................................................................. 4-1

After Using the HeartStart FR2+ ............................................................. 4-2

Cleaning the HeartStart FR2+ ......................................................... 4-3

Operator’s checklist ............................................................................ 4-3

Testing ........................................................................................................... 4-5

Battery insertion selftest .................................................................... 4-5

Periodic selftests ................................................................................. 4-9

Device history ....................................................................................... 4-9

Battery History ..................................................................................... 4-10

Troubleshooting Guide .............................................................................. 4-11

Status indicator summary .................................................................. 4-11

Recommended action during an emergency ................................ 4-11

Troubleshooting during patient use ................................................ 4-12

General troubleshooting .................................................................... 4-14

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5 Clinical and Safety Considerations

Clinical Considerations .............................................................................. 5-1

Indications ............................................................................................. 5-1

Contraindications ................................................................................ 5-1

Safety Considerations ................................................................................ 5-1

General dangers, warnings, and cautions ..................................... 5-2

Defibrillation warnings and cautions ............................................... 5-4

Monitoring cautions ............................................................................ 5-5

Maintenance cautions ........................................................................ 5-5

6 Setup and Advanced Mode Features

Setup Overview ........................................................................................... 6-1

Non-protocol parameters .................................................................. 6-1

Automatic protocol parameters ....................................................... 6-2

Manual override parameters ............................................................. 6-4

Using Setup Features ........................................................................ 6-5

Reviewing current setup .................................................................... 6-6

Revising setup ...................................................................................... 6-6

Receiving setup ................................................................................... 6-7

Reading setup ...................................................................................... 6-8

Sending and Receiving Clock Settings ................................................. 6-8

Using Advanced Mode Features ............................................................. 6-9

Using the manual analyze feature .................................................... 6-10

Using the manual charge feature (M3860A only) ........................ 6-11

7 Data Management and Review

Overview ....................................................................................................... 7-1

Recording Incident Data ............................................................................ 7-1

Recording data in internal memory ................................................. 7-1

Recording data on a data card ........................................................ 7-1

Reviewing Incident Data ............................................................................ 7-3

Reviewing data from internal memory ............................................ 7-3

Reviewing data from a data card ..................................................... 7-4

M3860A/M3861A HEARTSTART FR2+

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Appendices

A Accessories for the HeartStart FR2+

HeartStart Accessories ............................................................................. A-1

Suggested Additional Items ..................................................................... A-2

B Technical Specifications

HeartStart FR2+ Defibrillator Specifications ........................................ B-1

Accessories Specifications ...................................................................... B-6

C Glossary of Symbols and Controls

Instructions for Use ..................................................................................... C-1

HeartStart FR2+ M3860A and M3861A Defibrillator

Symbols and Controls ................................................................................ C-1

Accessories Symbols ................................................................................. C-3

D Glossary of Terms

Index

Contents

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Notes

M3860A/M3861A HEARTSTART FR2+

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Introduction to the HeartStart FR2+

What is the HeartStart FR2+?

The HeartStart FR2+ Defibrillator (“FR2+”) is an automated external

defibrillator. It is compact, lightweight, portable, and battery powered. It is

designed for simple and reliable operation by a trained responder.

NOTE: The HeartStart FR2+ is an enhanced version of the defibrillator

previously sold as the Heartstream FR2. The FR2+ has all the features of the

FR2. All accessories compatible with the FR2 are also compatible with the

FR2+. However, the FR2+ has some new features not present in the FR2

and can be used with certain accessories (labeled FR2+) that are not

compatible with the FR2.

The FR2+ has a Status Indicator that is always active, so you can tell at a

glance if it is ready for use. The front panel of the FR2+ has an On/Off button

at the top and a Shock button at the bottom. A display screen in the center of

the panel provides text prompts and incident information. Voice prompts are

provided through a speaker located at the base of the FR2+. (See the

diagram on the inside front cover for details.)

The FR2+ is available in two models, the M3860A and the M3861A. They

share a set of basic features, detailed in Chapter 6. The principle differences

between the two models are identified below:

model M3860A

model M3861A

Configurable ECG display on screen

Text prompt display on screen, no ECG

display

Configurable manual charge in

advanced mode

No manual charge in advanced mode

NOTE: The FR2+ comes with a factory default setup that can be modified.

(See Chapter 6, “Setup and Advanced Mode Features,” for a description of

setup defaults and options.)

1-1

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1-2

When Is the HeartStart FR2+ Used?

The HeartStart FR2+ Defibrillator is used with disposable defibrillator pads

applied to a person who is experiencing the symptoms of sudden cardiac

arrest (SCA): lack of responsiveness and lack of breathing. Defibrillation

should not be performed on anyone who is responsive or is breathing.

Infant/child reduced-energy defibrillator pads are available for use with the

FR2+ on children under the age of 8 or weighing less than 55 pounds (25

kg).

The FR2+ is intended for use by emergency care personnel who have been

specifically trained in the operation of the FR2+ or who are qualified by

training in Basic Life Support (BLS), in Advanced Life Support (ALS), or in

other physician-authorized emergency medical response.

At the discretion of emergency care personnel, the M3860A FR2+ with

ECG display enabled can also be used with the FR2+ ECG assessment

module to display the rhythm of a responsive or breathing patient, regardless

of age. The FR2+ Defibrillator used with the FR2+ ECG assessment module

provides a non-diagnostic display for attended patient monitoring. While

connected to the FR2+ ECG assessment module, the FR2+ displays and

evaluates the patient's ECG and disables its shock capability.

How Does the HeartStart FR2+ Work?

The HeartStart FR2+ Defibrillator is designed to provide external

defibrillation therapy to someone in cardiac arrest. Defibrillation therapy is

the best available way to treat a variety of potentially fatal heart arrhythmias.

The FR2+ is extremely easy to use. When connected to defibrillator pads

that are properly applied to the patient’s bare chest, the FR2+:

1. prompts you to take specific actions,

2. automatically analyzes the patient's heart rhythm and advises you

whether or not the rhythm is shockable, and

3. arms the Shock button, if appropriate, and instructs you to press it to

deliver a biphasic electric pulse designed to defibrillate the heart.

Detailed instructions for use are provided in Chapter 3.

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1-3

How Is the HeartStart FR2+ Supplied?

The HeartStart FR2+ Defibrillator is supplied with a standard long-life

battery, two sets of adult defibrillator pads with integrated cable and

connector, and a data card tray. Other accessories, including an FR2+

rechargeable battery, FR2 infant/child reduced-energy defibrillator pads, and

(for M3860A only, with ECG display enabled) a three-wire FR2+ ECG

assessment module, are available. See Appendix A for a list of accessories

and other recommended supplies.

Introduction to the HeartStart FR2+

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Notes

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Preparing Your HeartStart FR2+ for

Use

Overview

There are a few basic steps to preparing your HeartStart FR2+ Defibrillator

for use:

ꢀ

Install data card (optional).

Install a battery.

Set the clock in the FR2+ (optional).

Run the battery insertion selftest.

Place the FR2+ with recommended accessories in a convenient

location.

The instructions presented here briefly describe the normal sequence of

preparation. It assumes that you are using a fresh battery, that the selftest

passes, that you are not using a data card, and that the factory default

settings will not be changed. Exceptions to this sequence are provided

elsewhere in this manual.

Installing the Battery

The HeartStart FR2+ Defibrillator is shipped with a M3863A standard,

long-life battery. The battery is enclosed in a gray plastic case. There is a

yellow latch at one end that holds the battery in place when it is correctly

installed in the FR2+. (The optional M3848A FR2+ rechargeable battery is

enclosed in a blue plastic case and also has a yellow latch. Except where

otherwise noted, the following information applies to both battery types.)

Before installing the battery, make sure the defibrillator pads are not

connected to the FR2+. To install the battery:

1. Hold the battery by the latch end and slide it into the battery

compartment at the top of the FR2+.

2. Slide the battery all the way into the opening, until the latch clicks into

place. The latch will click into place only when the battery is inserted

correctly.

CAUTION: Follow all instructions supplied with the HeartStart M3863A

standard battery. Install the battery before the install-by date shown on the

battery.

2-1

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2-2

When the battery is installed, the FR2+ automatically turns on. The Status

Indicator displays a flashing black hourglass. The Shock button light and the

indicator light for the defibrillator pads connector socket turn on briefly.

The display screen brings up the main menu. From this menu, you can start

the FR2+ battery insertion selftest, review information from the last time the

FR2+ was used, or go to the next screen for other options. Information about

the optional data card and the battery status is also provided. (See Chapter

7, “Data Management and Review,” for details about reviewing an incident

and using a data card.) For the M3863A standard battery, a GOOD BATTERY

message should be displayed. For the M3848A FR2+ rechargeable battery,

a “fuel gauge” graphic illustrates remaining power. Throughout the remainder

of this manual, the screen displays illustrated will be for the standard battery

unless otherwise noted.

NOTE: This screen will not be displayed if the FR2+ is connected to

defibrillator pads (that are applied to the patient) when the battery is inserted,

and you will not be able to access the menu items. In addition, the battery

insertion selftest and periodic automatic selftests cannot run while the

defibrillator pads are connected to the patient. Be sure to unplug the pads

connector from the FR2+ after each use. Do not store the FR2+ with the

pads connected.

NOTE: To move around the menus displayed, use the Option buttons as

follows:

•

Press the LOWER Option button to move the highlight bar from one

item to another on the menu.

•

Press the UPPER Option button to select the highlighted item or to

scroll through the settings for that item.

If you select NEXT, the menu displayed lets you review the history of the

FR2+, review the history of the battery being used, access setup data, set

the clock, or return to the first menu. (See Chapter 4, “Maintaining, Testing,

and Troubleshooting Your HeartStart FR2+,” for details about the review

options and Chapter 6, “Setup and Advanced Mode Features,” for

information on the setup option.)

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NOTE: If you make no selection for 10 seconds, the selftest will

automatically run. If you want to select something different from either of

these menus, you must do so before the selftest begins, or remove and

reinstall the battery to bring up the main menu. You can press the On/Off

button at any time to turn off the FR2+ and return it to standby (ready for

use) mode. To use the FR2+, press the On/Off button again.

Setting the Clock

It is recommended that the first time you prepare your HeartStart FR2+

Defibrillator for use, you check the FR2+’s internal clock to be sure it is set to

the correct date and local time. You can reset it if necessary.

To see the clock settings, select NEXT from the first menu, within 10 seconds

of installing the battery, and then select CLOCK. To do this:

1. Press the lower Option button to move the highlight bar to NEXT.

2. Press the upper Option button to bring up the NEXT screen.

3. Press the lower Option button to move the highlight bar to CLOCK.

4. Press the upper Option button to bring up the CLOCK screen.

The CLOCK screen displays the date and time currently set in the internal

clock of the FR2+.

NOTE: The date is displayed as day (DD), month (MM), and year (YY), as

shown on the screen. The time is displayed using the 24-hour international

clock.

If no changes to the clock settings are needed, select RETURN and go back

to the first menu. If the date and time are not correct, there are two ways to

set them:

ꢀ

Receive the clock settings from another FR2+ or from a computer using

HeartStart Event Review® software, using the RECEIVE TIME option.

This may be used to synchronize the clocks of several FR2+s. You can

also send the clock settings from one FR2+ to another one, using the

SEND TIME option. See Chapter 6, “Setup and Advanced Mode

Features,” for instructions.

ꢀ

Manually set the date and the time.

HeartStart Event Review software was previously sold as CodeRunner software.

Preparing Your HeartStart FR2+ for Use

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2-4

To manually set the clock:

1. Use the lower Option button to move the highlight bar to the part of the

clock setting you want to change.

2. Press the upper Option button repeatedly to scroll through the settings

until you reach the one you want. If you go past it, keep scrolling until it

comes up again.

3. Use the lower Option button to select the next part you want to change,

and repeat the process, until all parts of the date and time have been set.

4. When you have made all the changes, move the highlight bar to RETURN

and press the upper Option button to go back to the main menu screen.

NOTE: New clock settings are used by the FR2+ as soon as you set them.

The clock time display is updated each minute this screen is displayed. The

clock seconds, although not displayed, are set to 00 when you move the

highlight bar out of the time settings.

NOTE: If the battery is removed from the FR2+ for more than two hours, the

clock settings will be lost and must be reset.

Running the Battery Insertion Selftest

Except in an emergency, it is recommended that you run this selftest every

time you change the battery. Make sure the defibrillator pads are not

connected to the HeartStart FR2+ Defibrillator before running the battery

insertion selftest.

The selftest has two parts. The first part automatically tests the FR2+

circuitry. The second part is interactive and requires you to respond to

prompts in order to make sure the display, buttons, lights, speaker, and

beeper of the FR2+ are working properly. (See Chapter 4, “Maintaining,

Testing, and Troubleshooting Your HeartStart FR2+,” for details about this

selftest.)

To run the selftest:

1. Make sure the defibrillator pads are not connected to the device.

2. Insert the battery into the battery port. The first screen displayed has

RUN SELFTEST highlighted.

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2-5

3. Press the upper Option button to activate the test.

4. OR make no selection for 10 seconds, and the selftest will start

automatically if the FR2+ has been turned off for at least 5 minutes.

NOTE: If you connect defibrillator pads (that are applied to the patient) to

the FR2+ during a battery insertion selftest, the selftest will stop and the

FR2+ will go to its standby mode to be ready for use.

When the automatic part of the selftest is successfully completed, the screen

displays a message that the test has passed, and then automatically starts

the interactive part of the selftest. It is important to press the buttons and

verify the indicators to ensure that the FR2+ will be ready for use.

GOOD BATTERY

When the entire selftest is complete, the FR2+ automatically turns off and

returns to standby mode. In the standby mode, the Status Indicator displays

a flashing black hourglass. This means that the FR2+ has passed its most

recent self-test and is therefore ready for use, simply by pressing the On/Off

button to turn it on.

Placing and Securing the HeartStart FR2+

Place the HeartStart FR2+ Defibrillator in an accessible area with the Status

Indicator easily visible. Useful accessories for placing and securing the FR2+

include a carrying case, which is suitable for use with a wall mount bracket or

defibrillator cabinet. (See Appendix A for a list of accessories.)

NOTE: Do not store the FR2+ with the defibrillator pads attached. Do not

open the pads package until ready for use.

With the battery installed and the FR2+ stored in appropriate environmental

conditions, the FR2+ performs detailed periodic selftests to make sure that it

remains ready for use. (See Appendix B for the environmental storage

specifications.)

While the FR2+ is in the standby mode, the Status Indicator shows the

flashing black hourglass unless the periodic selftests detect a problem. If a

problem is detected, the Status Indicator will show a flashing red X or a solid

red X and the FR2+ will beep (“chirp”) to alert you to the need for

troubleshooting. (See Chapter 4, “Maintaining, Testing, and Troubleshooting

Your HeartStart FR2+,” for instructions.)

Preparing Your HeartStart FR2+ for Use

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Notes

M3860A/M3861A HEARTSTART FR2+

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Using Your HeartStart FR2+

Overview

This chapter describes how to use the HeartStart FR2+ Defibrillator in an

emergency incident. Some general things to remember are:

ꢀ

Try to relax and stay calm. The FR2+ automatically provides appropriate

voice and display prompts to guide you.

ꢀ

The defibrillator pads must have good contact with the patient’s skin.

The pads have a layer of sticky, conductive gel beneath the protective

backing. To work effectively, the gel must not be dried out.

ꢀ

It may be necessary to dry the patient’s skin or to clip or shave excessive

chest hair to provide good contact between the defibrillator pads and

the patient’s skin.

The following pages provide step-by-step instructions for normal use of the

FR2+ in an emergency. (See Chapter 4, “Maintaining, Testing, and

Troubleshooting Your HeartStart FR2+,” for troubleshooting tips.)

IMPORTANT: Be sure to read the Warnings and Cautions on the last page

of this chapter.

NOTE: These directions apply to both the model M3860A and the model

M3861A FR2+, except where otherwise noted.

3-1

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3-2

Step 1: Preparation

Press the On/Off button to turn on the HeartStart FR2+ Defibrillator.

Follow the instructions provided by the FR2+ voice and screen prompts

in the order indicated.

Remove clothing from the patient's upper body. Wipe moisture from the

patient's skin and clip or shave excessive chest hair, if necessary.

If the patient appears to be under eight years of age or 55 lbs (25 Kg), use

M3870A FR2 infant/child reduced-energy defibrillator pads, if available. If the

child appears older/larger, use adult defibrillator pads. DO NOT DELAY

TREATMENT TO DETERMINE THE CHILD’S EXACT AGE/WEIGHT.

Open the defibrillator pads package. Check to see that the pads and

attached cable and connector are undamaged. Pull off the protective

backing from the defibrillator pads and check that the gel has not dried out. If

the pads are damaged or the gel has dried out, use a new set of pads.

Place each pad on the patient. The pads must be placed with the sticky side

on the patient’s skin. IMPORTANT: Refer to the drawing on each pad for

correct positioning. For adult patients, one pad goes just below the

patient's right collarbone, and the other one goes over the patient’s ribs in

line with the armpit and below the left breast. For children under eight years

old, one pad is centered on the chest between the nipples, and the other on

the back between the scapulae (shoulder bones).

Connect the pads to the FR2+. Insert the defibrillator pads connector firmly

into the connector socket. A flashing light shows you where the socket is

located, at the top left of the FR2+.

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Step 2: ECG Analysis and Monitoring

Follow the instructions provided by the HeartStart FR2+ Defibrillator’s

voice and screen prompts in the order indicated.

As soon as the FR2+ detects that the defibrillator pads are connected

properly, it automatically begins analyzing the patient’s heart rhythm. Do not

touch the patient during rhythm analysis. The M3860A FR2+ can display the

patient’s ECG on the screen. When the ECG display is enabled, the

patient’s heart rate is also displayed during background monitoring and when

the advanced mode is entered.

If no shock is advised, the FR2+ provides voice and screen prompts to tell

you so. The FR2+ instructs you to perform CPR if needed, and performs

background monitoring of the patient’s ECG while you give appropriate care

to the patient. These instructions are repeated at the programmed Monitor

Prompt interval (the default interval is one minute) while the FR2+ is

monitoring the patient.

NOTE: CPR may interfere with background monitoring. During CPR,

periodically pause for 15 seconds to check the patient and allow the FR2+

to analyze the patient’s heart rhythm without CPR artifact.

Monitoring continues until and unless the FR2+ detects a change in the

patient’s heart rhythm that may be a shockable rhythm, detects interference

with rhythm analysis, or is turned off.

If the FR2+ detects a potentially shockable heart rhythm while monitoring, it

automatically goes back to analyzing the rhythm to see if a shock is advised.

If a shock is advised, the FR2+ charges to prepare for shock delivery. It

gives the voice warnings and screen prompts to tell you that a shock is

advised. Make sure that no one is touching the patient or the pads. While the

FR2+ is charging, it continues to analyze the patient’s heart rhythm. If the

rhythm changes and a shock is no longer appropriate, the FR2+ disarms.

Voice and display prompts advise you what action to take.

NOTE: When the FR2+ is fully charged, you can disarm it at any time by

pressing the On/Off button to turn off the FR2+ and return it to standby

mode. (See the Defibrillator discussion in Appendix B, “Technical

Specifications,” for details on disarming the FR2+.)

Using Your HeartStart FR2+

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3-4

Step 3: Shock Delivery

Press the Shock button to deliver the shock.

IMPORTANT: You must press the button for a shock to be delivered. The

HeartStart FR2+ Defibrillator will not automatically deliver a shock.

There are four ways you can tell that the FR2+ is ready to deliver a shock:

ꢀ

you hear a voice prompt telling you to deliver a shock,

you see the Shock button flashing,

you hear a steady tone, and/or

you see a screen prompt telling you to press the orange (Shock)

button.

After you press the Shock button, a voice prompt tells you the shock was

delivered. Then FR2+ goes back to analyzing the patient’s heart rhythm to

see if the shock was successful. The FR2+ continues to provide voice and

text prompts to guide you through additional shocks, if appropriate.

NOTE: If you do not press the Shock button within 30 seconds of being

prompted, the FR2+ will disarm itself and provide a pause. The device will

resume analyzing after 30 seconds or when the Resume Analyzing key is

pressed.

Pause for CPR. After the programmed number of shocks in a shock series

are delivered, the FR2+ automatically pauses for a programmed amount of

time to allow you to perform CPR. After the voice and screen prompts tell

you that the FR2+ has paused, there are no further voice prompts during the

rest of the pause, so that you can provide uninterrupted patient care.

During the pause, the FR2+ screen shows a bar that fills in as the pause time

is used up. The screen also shows how much time has gone by since the

FR2+ was turned on,* and how many shocks have been delivered. The

M3860A FR2+ also displays the ECG, if enabled, during this period.

The FR2+ displays elapsed time to a maximum of 99:59 minutes. If the elapsed time

of use extends beyond this figure, the minutes are represented by “??” but the

seconds are displayed. However, total elapsed time will be recorded on an installed

data card for later review with HeartStart Event Review data management software.

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3-5

ECG Display for Ongoing Observation

At the discretion of emergency care personnel, the M3860A FR2+ with

ECG display enabled can also be used with the M3873A/M3874A FR2+

ECG assessment module. The FR2+ used with the FR2+ ECG assessment

module provides a non-diagnostic ECG display of the patient’s heart rhythm

for attended patient monitoring. The system is intended for use on a

conscious or breathing patient, regardless of age. While connected to the

FR2+ ECG assessment module, the FR2+'s shock capability is disabled,

but the FR2+ continues to evaluate the patient's ECG. The module is

designed for connection to ECG electrodes per AAMI (M3873A) or IEC

(M3874A) color convention.

There are no known contraindications to use of the FR2+ ECG assessment

module.

The module’s colored leadwires are connected to ECG electrodes, which

are then placed on the patient’s bare chest, and the module’s device

connector is inserted in the FR2+’s connector socket.

NOTE: It is not necessary to turn the FR2+ Defibrillator off prior to

connecting the ECG assessment module.

Once connected, the FR2+ displays and evaluates the patient's ECG (Lead

II). Follow all prompts from the FR2+. If a data card is used when the module

is connected to the FR2+, all recorded events can be viewed using

HeartStart Event Review data management software^*on a personal

computer.

Check the patient if:

ꢀ

indicated by the observed ECG display,

the patient becomes unresponsive or stops breathing, or

the FR2+ prompts IF NEEDED, ATTACH DEFIBRILLATION PADS.

If appropriate, unplug the ECG assessment module from the FR2+, attach

the defibrillator pads to the patient, and connect the defibrillator pads to the

FR2+. Verify that the defibrillator pads are at least one (1) inch (2.5 cm)

away from the ECG electrodes.

The M3873A/M3874A FR2+ ECG assessment module contains no latex

rubber. It is reusable (see the expiration date on the module) and can be

cleaned with a soft cloth dampened with any of the agents recommended for

HeartStart Event Review software was previously sold as CodeRunner software.

Using Your HeartStart FR2+

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3-6

cleaning the FR2+ Defibrillator. (See Chapter 4, “Maintaining, Testing, and

Troubleshooting Your HeartStart FR2+.”)

WARNING: During defibrillation, air pockets between the skin and

defibrillator pads can cause patient skin burns. To help prevent air pockets,

make sure defibrillator pads completely adhere to the skin. Do not use

dried-out defibrillator pads.

WARNING: Do not let the defibrillator pads touch each other or other ECG

electrodes, lead wires, dressings, transdermal patches, etc. Such contact

can cause electrical arcing and patient skin burns during defibrillation and

may divert defibrillating current away from the heart.

WARNING: Handling or transporting the patient during heart rhythm

analysis can cause an incorrect or delayed diagnosis. If the FR2+ gives a

SHOCK ADVISED prompt, keep the patient as still as possible for at least 15

seconds so the FR2+ can reconfirm the rhythm analysis before a shock is

delivered.

WARNING: CPR rates significantly above 100 compressions per minute

can cause incorrect or delayed analysis by the FR2+.

WARNING: Defibrillation current can cause operator or bystander injury.

Do not touch the patient during defibrillation. Do not allow the defibrillator

pads to touch any metal surfaces. Disconnect the pads connector from the

FR2+ before using any other defibrillator.

CAUTION: Aggressive handling of the pads in storage or prior to use can

damage the pads. Discard the defibrillator pads if they become damaged.

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Maintaining, Testing, and

Troubleshooting Your HeartStart FR2+

Overview

This chapter provides information on HeartStart FR2+ Defibrillator

maintenance, detailed descriptions of the selftests, and a guide to

troubleshooting.

Maintenance

Maintenance of the FR2+ is very simple, but it is a very important factor in its

dependability. The FR2+ performs many maintenance activities itself. These

include daily and weekly selftests to verify readiness for use and more

detailed monthly selftests that also verify the shock waveform delivery

system. In addition, a detailed selftest is run whenever a battery is installed in

the FR2+.

The FR2+ requires no calibration or verification of energy delivery. The FR2+

has no user-serviceable parts.

CAUTION: Improper maintenance may damage the FR2+ or cause it to

function improperly. Maintain the FR2+ only as described in this User's

Guide or as designated by your program's Medical Director.

CAUTION: Electrical shock hazard. Dangerous high voltages and currents

are present. Do not open the FR2+, remove its covers, or attempt repair.

There are no user-serviceable components in the FR2+. The FR2+ should be

returned to an authorized service center for repair.

The following table presents a schedule of suggested maintenance for the

FR2+. Different frequency intervals may be appropriate, depending upon the

environment in which the FR2+ is used. The required maintenance frequency

is at the discretion of your program’s Medical Director.

4-1

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4-2

daily

monthly

maintenance task/response

Check the Status Indicator.

ꢀ

If you see the flashing black hourglass: The FR2+ is

ready to use. No action required.

If you see anything other than a flashing black

hourglass, remove and reinstall the battery to run the

selftest.

•

If the selftest passes and the Status Indicator

shows the flashing black hourglass, the FR2+ is

ready to use.

If the selftest fails, install a new battery and run the

selftest. If the selftest passes, the FR2+ is ready to

use. If the selftest fails, contact Philips Medical

Systems.

•

Check supplies, accessories, and spares for

damage and expiration dating.

ꢀ

Do not use damaged or expired accessories. Replace

them immediately.

If a LOW BATTERY or REPLACE BATTERY message is

displayed: Replace the battery and run the selftests.

DO NOT ATTEMPT TO CHARGE THE M3863A FR2

STANDARD BATTERY. It is not rechargeable. The

M3848A FR2+ battery is rechargeable. Recharge it,

using the M3849A Charger, for the FR2+

rechargeable battery only.

Check the outside of the FR2+ and the connector

socket for cracks or other signs of damage.

If you see signs of damage: Contact Philips Medical

Systems for technical support.

ꢀ

After Using the HeartStart FR2+

After each use of the FR2+, perform the maintenance tasks described in the

table above, as well as the following post-use checks before returning the

FR2+ to service:

ꢀ

Check the operation of the FR2+ by removing and reinstalling the

battery and running the battery insertion selftest. NOTE: Perform also

when replacing expired defibrillator pads.

Check the outside of the FR2+ and the connector socket for signs of

dirt or contamination. If the FR2+ is dirty or contaminated, clean it

according to the guidelines provided in this manual.

Check the data card if one has been used. If the data card has been

used to record incident data, remove and replace it with a blank data

card. Deliver the recorded data card to appropriate personnel according

to your local guidelines and medical protocol.

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ꢀ

Check the connector socket to make sure that defibrillator pads are

disconnected from the FR2+ when it is not in use.

Check to make sure the data card tray is installed, even if a data card

is not being used.

Cleaning the HeartStart FR2+

The outside of the FR2+, including the defibrillator pads connector socket,

can be cleaned with a soft cloth dampened in one of several appropriate

cleaning agents (see list below). The following guidelines include some

important reminders:

ꢀ

Do not immerse the FR2+ in fluids.

ꢀ

Make sure a battery (or the M3864A training & administration pack) and

a data card tray are installed when cleaning the FR2+, to keep fluids out

of the device.

ꢀ

Do not use abrasive materials, cleaners, strong solvents such as acetone

or acetone-based cleaners, or enzymatic cleaners.

Clean the FR2+ and the connector socket with a soft cloth dampened

with one of the cleaning agents listed below.

—

Isopropyl alcohol (70% solution)

Soapy water

Chlorine bleach (30 ml/l water)

Ammonia-based cleaners

Glutaraldehyde-based cleaners

Hydrogen peroxide

CAUTION: Do not immerse any portion of the FR2+ in water or other fluids.

Do not allow fluids to enter the FR2+. Avoid spilling any fluids on the FR2+

or accessories. Spilling fluids into the FR2+ may damage it or present a fire

or shock hazard. Do not sterilize the FR2+ or accessories.

Operator’s checklist

The checklist on the following page is for your reference. You may want to

photocopy it or use it as the basis for creating your own checklist.

Inspect the FR2+ as suggested in the maintenance schedule above, or as

specified by your Medical Director. When you use the Checklist, fill in the

scheduled frequency intervals you will be using for your maintenance

inspections.

Check off each requirement as you complete it, make a note of any problems

you found or corrective action you took, and sign the form.

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4-4

OPERATOR'S CHECKLIST

HeartStart FR2+ Model No.: ______________________Serial No.:__________________________________

HeartStart FR2+ Location or Vehicle ID: _______________________________________________________

date

scheduled frequency

HeartStart FR2+

Clean, no dirt or contamination;

no signs of damage

Supplies Available

•

Two sets defibrillator pads,

sealed, undamaged, within

expiration date

•

Ancillary supplies (hand

towel, scissors, razor, pocket

mask, gloves)

•

Spare M3863A battery,

within “Install Before” date

Data cards, undamaged, and

spare data card tray

Status Indicator

Shows alternating

hourglass/square; selftest

passed.

Inspected by

Signature or initials of operator

completing the maintenance

inspection

Remarks, Problems,

Corrective Actions

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4-5

Testing

The HeartStart FR2+ Defibrillator has several ways of testing itself and

alerting you if it finds a problem. In addition to the selftest performed each

time a battery is installed, the FR2+ also automatically performs periodic

selftests daily.

NOTE: The FR2+ selftests are designed to check that the FR2+ is ready for

use. However, in the event that the FR2+ has been dropped or mishandled, it

is recommended that the battery be removed and reinstalled to initiate a

selftest. If the FR2+ has visible signs of damage, contact Philips Medical

Systems for technical support.

Battery insertion selftest

As described in Chapter 2, “Preparing Your HeartStart FR2+ for Use,” when

you insert the battery in the FR2+, be sure that neither the defibrillator pads

nor the FR2+ ECG assessment module are connected to the device. When

you insert the battery, a menu is displayed and a two-part selftest will run

unless you make another selection from the menu within 10 seconds. The

selftest includes an automatic part and an interactive part.

NOTE: Under certain circumstances, the behavior of your FR2+ will be

different.

For example, the menu screen will not appear when a battery is inserted if:

•

the defibrillator pads are attached to a patient, indicating that the

FR2+ is in continued use,

•

the FR2+ ECG assessment module is connected to the FR2+, or

the battery is completely depleted.

The menu screen will be displayed, but after 10 seconds the FR2+ will go to

standby mode if you make no selection and:

•

less than five minutes have passed since the FR2+ was last used,

indicating that the FR2+ is still in use.

It is recommended that the full selftest (including the interactive portion) be

run under the following circumstances:

ꢀ

When the FR2+ is first put into service and following each use.

Whenever the battery is replaced.

Whenever expired defibrillator pads are replaced during periodic

maintenance.

ꢀ

Whenever the defibrillator may have sustained physical damage.

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4-6

When you install the battery, the screen tells you whether or not a data card

is installed. If so, a screen message displays how much recording time is left

until the data card is full. (See Chapter 7, “Data Management and Review,” for

how to review the incident information from the internal memory of the FR2+

or from a data card, if one is used.)

NOTE: The data card is typically capable of storing a number of incidents.

However, it is recommended that it be replaced after every use. In the unlikely

event that the card fills up during an incident, no further data can be

recorded, so it is important for you to monitor the CARD FULL IN... information

on this screen.

Screen contrast can be adjusted during the battery insertion selftest by using

the Option buttons.

If battery power is low, replace the battery. If a previous selftest has failed, the

screen displays a message that the FR2+ must pass a selftest before being

used.

It is recommended that you always have a spare battery available. However, if

a screen display prompts you to replace the battery or the Status Indicator

shows a flashing red X, but you do not have a spare battery, you can

continue to use the FR2+ until the battery is completely depleted. This may

be necessary in an emergency.

NOTE: It is recommended that the M3848A FR2+ rechargeable battery not

be used as a spare or backup battery.

NOTE: If you connect defibrillator pads (that are applied to the patient) or

the FR2+ ECG assessment module to the FR2+ during a battery insertion

selftest, the selftest will stop and the FR2+ will go to its standby mode to be

ready for use.

During the automatic part of the selftest, the screen displays a bar that fills in

as the test continues. When that part of the test is finished, the FR2+ beeps.

The results of the selftest are automatically recorded on the data card while

the tests are running, if a data card was inserted in the FR2+ prior to

installing the battery.

If the automatic part of the selftest fails:

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ꢀ

The screen displays a message that the selftest has failed. After a short

time, an error code is displayed. Write down the error code and contact

Philips Medical Systems for technical support.

The Status Indicator shows a flashing or solid red X.

Replace the battery with a new battery and repeat the test. If the second

selftest fails, contact Philips Medical Systems for technical support.

If the automatic part of the selftest passes:

ꢀ

The screen displays a message that the selftest passed, then begins the

interactive part of the test.

The interactive part of the selftest requires you to respond to prompts in

order to make sure the display, buttons, lights, and speaker on the FR2+ are

working properly.

Screen prompts guide you through a series of steps in the interactive part of

the selftest. Some ask you to observe that a feature of the FR2+ works

properly. Others ask you to take certain actions — for example, to press a

button. The screen then displays a message showing that the button’s

operation has been verified. If you do not press the button, or if you do but

the button is not working, the screen displays a message that the button’s

function is not verified.

It is important to press the buttons and verify the indicators to ensure that the

FR2+ will be ready for use. If something does not work correctly — for

example, if lights do not come on or you do not hear beeps when expected —

make a note of the problem and contact Philips Medical Systems for

technical support.

NOTE: Do not use the FR2+ until all parts of the interactive selftest verify

correct performance. Be sure to note and report any problems you find.

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4-8

The following table describes the parts of the FR2+ tested in the interactive

part of the selftest and any action you are asked to take.

feature

test description

speaker

Screen prompt: CHECK SPEAKER SOUND (2 beeps)

> Listen for the two beeps from the speaker.

lights

Screen prompt: CHECK SHOCK BUTTON LIGHT AND PADS CONNECTOR LIGHT

> Check that the lights come on.

option buttons

display screen

Screen prompt: PRESS THE OPTION BUTTONS

> Press the blue upper and lower Option buttons and listen for a beep to

confirm each press. Look at the screen to be sure the button presses

have been verified.

Screen prompt: CHECK DISPLAY. ADJUST CONTRAST IF NEEDED

> Check the test pattern displayed on the screen. Adjust the contrast if

desired using the Option buttons.

NOTE: Screen contrast can be adjusted at any time during the interactive

selftest by repeatedly pressing the appropriate Option button until

desired contrast is achieved.

shock button

Screen prompt: PRESS THE SHOCK BUTTON

> Press the Shock button and listen for a beep to confirm the press.

No shock will be delivered when you press the Shock button during the

test.

> Look at the screen to be sure the button press has been verified.

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feature

test description

on/off button

Screen prompt: PRESS THE ON/OFF BUTTON

> Press the On/Off button and listen for a beep to confirm press.

> Look at the screen to be sure the button press has been verified.

The screen then displays a message that the test is complete.

When the interactive part of the battery insertion selftest is complete, the

FR2+ turns off and goes to standby mode to be ready for use.

If proper operation of all features has not been verified in the interactive

selftest, you may want to rerun the battery insertion selftest. If a feature of

operation cannot be verified, contact Philips Medical Systems for technical

support.

Periodic selftests

In addition to the battery insertion selftest, the FR2+ automatically performs

periodic selftests (PSTs). These daily, weekly, and extensive monthly selftests

check many important functions of the FR2+, including battery capacity and

internal circuitry.

If it detects a problem during one of these periodic selftests, the FR2+

beeps and displays a flashing red X or a solid red X on the Status Indicator.

Device history

The FR2+ stores key information about its history in internal memory. To

review the history of your FR2+, select NEXT from the menu screen

displayed when you insert the battery, then select DEVICE HISTORY from the

next menu displayed.

The device history information is read from the internal memory of the FR2+.

It includes:

ꢀ

USES — how many times the FR2+ has been used (shown in the left

column of numbers) and the total time in minutes it has been used

(shown in the right column of numbers);

ꢀ

SHOCKS — the total number of shocks it has delivered;

TRAINING — how many times it has been used with the training &

administration pack for training (left column) and the total time in minutes

it has been used for training (right column); and

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4-10

ꢀ

TESTS — how many tests have been run. Four figures are shown: daily

(upper left), weekly (upper right), and monthly (lower left) periodic

selftests, and battery insertion selftests (lower right).

REV — device language, model, and software revision.

Battery History

Information about use of the battery currently installed in your FR2+ is also

available. To review the history of the battery, select NEXT from the menu

screen displayed when you insert the battery, then select BATTERY HISTORY

from the next menu displayed.

The battery history information is read from the internal memory of the battery.

It includes:

ꢀ

USE MINUTES — the total operating time (in minutes), including selftest

time, for this battery;

CHARGES — the total number of full defibrillation charges that have been

provided by this battery, including selftest charges;

BATTERY — a GOOD BATTERY (M3863A) or a fuel gauge display

(M3848A) showing 25%, 50%, 75% or 100%, or a LOW BATTERY or

REPLACE BATTERY message, as appropriate.

ꢀ

STATUS — the current status of this battery, displayed in a binary code.

Make a note of this code if technical service is needed.

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4-11

Troubleshooting Guide

Status indicator summary

status indicator

meaning

Flashing black hourglass

The FR2+ passed the battery insertion self-test or the last periodic self-test and is

therefore ready for use.

Flashing red X

A self-test error has occurred or the battery is low or depleted.

accompanied by a chirping

sound.

Solid red X

The battery is completely depleted or a self-test failure occurred.

NOTE: Perform CPR (if needed) any time there is a delay before the FR2+

can be used.

Recommended action during an emergency

If the status indicator displays the flashing black hourglass, follow all voice

and screen prompts.

The HeartStart FR2+ Defibrillator is designed to continue working even if the

status indicator displays a flashing red X, although the device may not

perform to all of its specifications. Voice and text prompts should be followed

whenever they are given. If for any reason you cannot hear voice prompts

during use of the defibrillator, periodically check the device screen for text

prompts.

NOTE: After completing emergency use of the FR2+, if you are unable to

clear the problem as described in this Troubleshooting section, and the

Status Indicator does not show the flashing black hourglass, contact Philips

Medical Systems for technical support.

In the unlikely event that the device becomes unresponsive during use:

1. cycle power (press the On/Off button once, wait one second, then press

it again), or

2. remove and reinstall the battery (use a new M3863A FR2 standard

battery, if available, or a charged M3848A FR2+ rechargeable battery).

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4-12

If neither of these actions clears the problem, do not use the FR2+. Attend to

the patient, providing CPR if needed, until emergency medical personnel

arrive.

Troubleshooting during patient use

symptom

STATUS INDICATOR: FLASHING RED X

possible cause

recommended action

Screen and voice prompts:

LOW BATTERY

• The energy remaining in the battery is

low.

• The energy in the battery is nearly

depleted. The FR2+ will turn off if a

new battery is not installed.

• Replace the battery with a new

M3863A FR2 standard or a

charged M3848A FR2+

rechargeable battery as soon as

possible.

Screen and voice prompts:

REPLACE BATTERY NOW

STATUS INDICATOR: FLASHING BLACK HOURGLASS

Screen and voice prompts:

APPLY PADS AND

PRESS PADS FIRMLY

The defibrillator pads:

• are not properly applied to the patient,

• are not making good contact with the

patient's bare chest because of

moisture or excessive hair, or

• are touching each other.

The defibrillator pads connector:

• is not firmly inserted in the connector

socket.

• Make sure that the defibrillator

pads are sticking completely to

the patient’s skin.

• If the pads are not sticking, dry the

patient's chest and shave or clip

any excessive chest hair.

• Reposition the pads.

• Make sure the pads connector is

completely inserted in the

PLUG IN CONNECTOR

Or voice prompts:

INSERT CONNECTOR FIRMLY

PRESS PADS FIRMLY TO

PATIENT'S BARE CHEST

connector socket.

If the prompt continues after you do

these things, replace the pads.

POOR PADS CONTACT

Voice and screen prompts:

REPLACE PADS

• The defibrillator pads, cable, or

connector may be damaged.

• The FR2+ has detected a possible

problem with the defibrillator pads or

pads cable.

Replace the defibrillator pads with

new defibrillator pads.

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symptom

Voice prompts:

ANALYZING INTERRUPTED

CANNOT ANALYZE

STOP ALL MOTION

possible cause

recommended action

• The patient is being moved or jostled.

• Radio or electrical sources are

interfering with ECG analysis.

• The environment is dry and movement

around the patient is causing static

electricity to interfere with ECG

analysis.

• Stop CPR; do not touch the

patient. Minimize patient motion. If

the patient is being transported,

stop the vehicle if needed.

• Check for possible causes of

radio and electrical interference

and remove them from the area.

• Responders and bystanders

should minimize motion,

particularly in dry environments

that can generate static electricity.

Voice and screen prompts:

NO SHOCK DELIVERED

The patient impedance is not appropriate

for the FR2+ to deliver a shock.

• Make sure the defibrillator pads

are correctly positioned on the

patient according to the diagram

on the back of the pads.

• Make sure the defibrillator pads

connector is completely inserted

in the connector socket.

• Press the defibrillator pads firmly

to the patient's chest.

• Replace the defibrillator pads if

necessary.

Voice prompt:

SHOCK BUTTON NOT

PRESSED

Shock has been advised but not delivered

within 30 seconds. (FR2+ has been

disarmed.)

• When next prompted, press the

Shock button to deliver shock.

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4-14

General troubleshooting

symptom

Status Indicator:

possible cause

recommended action

• The energy remaining in the battery is

low.

• The FR2+ has been stored outside the

recommended temperature range.

• An error has been detected as part of

the self-test.

• Replace battery with a new

M3863A FR2 standard or a

charged M3848A FR2+

rechargeable battery as soon as

possible.

• Remove and reinstall the battery

and run a battery insertion

self-test. A screen prompt will tell

you if the FR2+

FLASHING RED X

Audio signal:

CHIRPING

• The FR2+ has been unable to perform

its daily self-tests.

has been stored outside the

recommended temperature range.

See Appendix B for recommended

range.

• Remove and reinstall the battery

and perform the battery insertion

self-test. If it fails, install a new

battery and repeat the test. If it

fails again, do not use the FR2+.

• Make sure defibrillator pads are

not attached to the FR2+.

Status Indicator:

FLASHING OR SOLID RED X

A test revealed a failure or error. The

FR2+ performs self-tests every time it is

turned on, when a battery is inserted, and

periodically while it is in standby mode.

• Unplug the pads connector from

the FR2+, if connected.

• Remove and reinstall the battery

and check the results of the

Audio signal:

CHIRPING

battery insertion self-test. If it fails,

install a new M3863A FR2

standard battery or a charged

M3848A FR2+ rechargeable

battery and repeat the test. If it

fails again, do not use the FR2+.

Screen prompt (displayed

for 10 seconds at the end

of a BIT, before FR2+ turns

off):

NOT READY FOR USE

NOTE: You can stop the tests and

use the FR2+ as soon as you see

the Status Indicator change to the

flashing black hourglass. Simply

press the On/Off button to stop the

test and put the FR2+ into standby

mode. The FR2+ is then ready for

use.

SELFTEST FAILED

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symptom

Status Indicator:

possible cause

recommended action

• The battery is missing or completely

depleted.

• Install a new M3863A FR2

standard battery or a charged

M3848A FR2+ rechargeable

battery in the FR2+ and perform

the battery insertion test (BIT).

• Remove the training &

SOLID RED X

• The training & administration pack is

being used in the administration

function (the solid red X is normal in

this case) or has been left in the FR2+

by mistake.

Audio signal:

NONE

administration pack and install a

battery.

• A self-test detected a failure.

• Remove and reinstall the battery

and perform the battery insertion

self-test. If it fails, install a new

M3863A FR2 standard battery or

a charged M3848A FR2+

rechargeable battery and repeat

the test. If it fails again, do not use

the FR2+.

Status Indicator:

SOLID RED X

• The training & administration

pack is being used in the

• To continue using the training &

administration pack, press any

button (except On/Off).

• To return the FR2+ to standby

mode, remove the Pack and install

a battery.

ADMINISTRATION function

Audio signal:

CHIRPING

and more than 10 minutes have

passed without user interaction

(button press or pads change).

• The training & administration pack is

being used in the TRAINING function

and more than 30 minutes have

passed without user interaction

(button press or pads change).

Status Indicator:

NONE

The FR2+ has been physically damaged.

• Check for visible damage. Do not

use the FR2+ if it appears to be

damaged.

• Remove and reinstall the battery to

perform the battery insertion

self-test. If it fails, install a new

M3863A FR2 standard battery or

a charged M3848A FR2+

rechargeable battery and repeat

the test. If it fails again, do not use

the FR2+.

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Notes

M3860A/M3861A HEARTSTART FR2+

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Clinical and Safety Considerations

Clinical Considerations

Indications

The HeartStart FR2+ is indicated for use on victims of sudden cardiac arrest

exhibiting the following signs:

ꢀ

Unresponsiveness

ꢀ

Absence of normal breathing

The HeartStart FR2+ is intended for use by personnel who have been

trained in its operation. The user should be qualified by training in basic life

support, advanced life support, or other physician-authorized emergency

medical response.

NOTE: At the discretion of emergency care personnel, the M3860A FR2+

with ECG display enabled can also be used with the FR2+ ECG

assessment module to display the rhythm of a responsive or breathing

patient, regardless of age. There are no known contraindications to use of

the FR2+ ECG assessment module.

Contraindications

The HeartStart FR2+ is contraindicated for use (should not be used) on

patients who show either of the following signs:

ꢀ

Responsiveness

ꢀ

Presence of normal breathing

Safety Considerations

You should be aware of the safety concerns listed here when you use the

HeartStart FR2+. Read them carefully. You will also see some of these

messages in other parts of this manual. The messages are labeled Danger,

Warning, or Caution.

ꢀ

DANGER— immediate hazards that will result in personal injury or

death.

ꢀ

WARNING— conditions, hazards, or unsafe practices that can

result in serious personal injury or death.

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5-2

ꢀ

CAUTION — conditions, hazards, or unsafe practices that can

result in minor personal injury, damage to the HeartStart FR2+, or

loss of data stored in the device.

THESE SAFETY CONSIDERATIONS ARE DIVIDED INTO FOUR

GROUPS: SAFETY CONCERNS ABOUT THE HEARTSTART FR2+ IN

GENERAL USE, DEFIBRILLATION, MONITORING, AND MAINTENANCE

ACTIVITIES.

The dangers, warnings, and cautions listed in the following tables apply to

both the model M3860A and the model M3861A HeartStart FR2+, unless

otherwise noted.

General dangers, warnings, and cautions

safety level

possible shock or fire hazard, or explosion

DANGER

THERE IS A POSSIBILITY OF EXPLOSION IF THE HEARTSTART

FR2+ IS USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS

OR CONCENTRATED OXYGEN.

DANGER

THE HEARTSTART FR2+ HAS NOT BEEN EVALUATED OR

APPROVED FOR USE IN HAZARDOUS LOCATIONS AS DEFINED IN

THE NATIONAL ELECTRICAL CODE (ARTICLES 500-503). IN

ACCORDANCE WITH THE IEC CLASSIFICATIONS (SECTION 5.5.),

THE HEARTSTART FR2+ IS NOT TO BE USED IN THE PRESENCE OF

FLAMMABLE SUBSTANCE/AIR MIXTURES.

DANGER

DO NOT RECHARGE THE M3863A FR2 STANDARD BATTERY.

WARNING

Use the HeartStart FR2+ only as described in this manual. Improper

use of the HeartStart FR2+ can cause death or injury. Do not press

the Shock button if the defibrillator pads are touching each other or

are open and exposed.

CAUTION

Hazardous electrical output. The HeartStart FR2+ is for use only by

qualified personnel.

Do not immerse any portion of the HeartStart FR2+ in water or other

fluids. Do not allow fluids to enter the HeartStart FR2+. Avoid spilling any

fluids on the HeartStart FR2+ or accessories. Spilling fluids into the

HeartStart FR2+ may damage it or present a fire or shock hazard. Do not

sterilize the HeartStart FR2+ or accessories.

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safety level

possible improper device performance

WARNING

Prolonged or aggressive CPR to a patient with defibrillator pads

attached can damage the pads. Replace the defibrillator pads if they

are damaged during use or handling.

WARNING

Using damaged or expired equipment or accessories may cause the

HeartStart FR2+ to perform improperly, and/or injure the patient or

the user.

WARNING

CPR rates significantly above 100 compressions per minute can

cause incorrect or delayed analysis by the HeartStart FR2+.

Poor electrode pad-to-patient contact may result in a related

defibrillator prompt or other indication. Check all electrical and

patient connections.

CAUTION

The HeartStart FR2+ is designed to be used only with Philips-approved

accessories. The HeartStart FR2+ may perform improperly if

non-approved accessories are used.

Follow all instructions supplied with the HeartStart defibrillator pads. Use

the defibrillator pads before the expiration date shown on the package. Do

not reuse the defibrillator pads. Discard them after use.

CAUTION

Aggressive handling of the defibrillator pads in storage or prior to use can

damage the pads. Discard the defibrillator pads if they become damaged.

Follow all instructions supplied with the M3863A FR2 standard battery.

Install the battery before the expiration date shown on the battery.

Follow all instructions supplied with the M3848A FR2+ rechargeable

battery. Recharge using the M3849A charger only.

CAUTION

Do not use the M3849A charger on aircraft.

The HeartStart FR2+ was designed to be sturdy and reliable for many

different field use conditions. However, excessively rough handling can

result in damage to the HeartStart FR2+ or its accessories. Inspect the

unit and accessories periodically according to instructions.

CAUTION

Alteration of the factory default setup of the FR2+ can affect its

performance and should be performed under the authorization of your

Medical Director. Modifications to device operation resulting from

changes to the default settings should be specifically covered in user

training.

Clinical and Safety Considerations

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safety level

possible improper device performance

CAUTION

Use only Philips-approved data cards. The HeartStart FR2+ may perform

improperly if non-approved accessories are used.

safety level

possible electrical interference with ECG monitoring

WARNING

Radio-frequency (RF) interference from devices such as cellular

phones and two-way radios can cause improper HeartStart FR2+

operation. The HeartStart FR2+ should be used at least 6 feet (2

meters) away from RF devices, as stated in accordance with EN

61000-4-3:1996.

Defibrillation warnings and cautions

safety level

possible shock hazard

WARNING

Defibrillation current can cause operator or bystander injury. Do not

touch the patient during defibrillation. Disconnect the pads connector

from the HeartStart FR2+ before using any other defibrillator.

safety levels

possible ECG misinterpretation

WARNING

For safety reasons, some very low-amplitude or low-frequency heart

rhythms may not be interpreted by the HeartStart FR2+ as shockable

VF rhythms. Also, some VT rhythms may not be interpreted as

shockable rhythms.

WARNING

Handling or transporting the patient during heart rhythm analysis can

cause an incorrect or delayed diagnosis. If the HeartStart FR2+ gives

a SHOCK ADVISED prompt, keep the patient as still as possible for at

least 15 seconds so the HeartStart FR2+ can reconfirm the rhythm

analysis before a shock is delivered.

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safety levels

possible burns and ineffective energy

WARNING

Do not allow the defibrillator pads to touch each other or other ECG

electrodes, lead wires, dressings, transdermal patches, etc. Such

contact can cause electrical arcing and patient skin burns during

defibrillation and may also divert the defibrillation current away from

the heart.

WARNING

During defibrillation, air pockets between the skin and defibrillator

pads can cause patient skin burns. To help prevent air pockets, make

sure defibrillator pads completely adhere to the skin. Do not use

dried out defibrillator pads.

safety level

possible patient injury

CAUTION

The HeartStart FR2+ advanced mode’s MANUAL CHARGE feature is

intended for use only by authorized operators who have been specifically

trained in cardiac rhythm recognition and in defibrillation therapy using

manual charge and shock delivery.

Monitoring cautions

safety level

possible misinterpretation of ECG recordings

CAUTION

The LCD screen on the HeartStart FR2+ model M3860A is intended only

for basic ECG rhythm identification. The frequency response of the

monitor screen is not intended to provide the resolution needed for

diagnostic and ST segment interpretation.

Maintenance cautions

safety level

possible fire or shock hazard

CAUTION

Electrical shock hazard. Dangerous high voltages and currents are

present. Do not open the HeartStart FR2+, remove its covers, or attempt

repair. There are no user-serviceable components in the HeartStart FR2+.

The HeartStart FR2+ should be returned to an authorized service center

for repair.

Clinical and Safety Considerations

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safety level

possible fire or shock hazard

CAUTION

Improper maintenance may damage the HeartStart FR2+ or cause it to

function improperly. Maintain the HeartStart FR2+ only as described in

this User's Guide or as designated by your program's Medical Director.

M3860A/M3861A HEARTSTART FR2+

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Setup and Advanced Mode Features

Setup Overview

The “setup” of the HeartStart FR2+ Defibrillator is made up of several

programmable aspects, or parameters, of FR2+ operation. Some setup

parameters govern specific features that are not related to the patient care

protocol, some are used to define the automatic patient care protocol used

by the FR2+, and some provide options for manual override of the protocol

during use.

The FR2+ comes with a factory default setup designed to meet the needs of

most users. If desired, your Medical Director can revise the setup. Even if no

changes are made, however, it is a good idea to understand the setup of your

FR2+ and how the different parameter settings affect the way the device

works.

Non-protocol parameters

The parameters listed in the following table enable features of FR2+

operation that are not related to the patient treatment protocol. The table

describes each of these non-protocol parameters, lists the settings available

for it, and identifies the default setting.

parameter

settings

default

description

speaker volume

1, 2, 3, 4,

5, 6, 7, 8

Sets volume of the FR2+’s speaker. 1 is lowest; 8 highest.

The speaker is used for voice prompts and the

charge-done tone.

record voice

YES, NO

ON, OFF

Enables or disables the audio recording during incident.

Voice recording requires use of a data card.

ECG display

(M3860A only)

Enables (ON) or disables (OFF) ECG display on the

screen.

FR2+ rhythm analysis does not require ECG display to be

on. (ECG display cannot be changed from default OFF

for M3861A.)

autosend PST

ON, OFF

OFF

Enables (ON) or disables (OFF) transmission of the

results of the FR2+’s periodic selftests (PST) from its

infrared communications port.

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Automatic protocol parameters

The HeartStart FR2+ is designed to follow an automatic protocol that guides

you through patient treatment with the defibrillator. The default settings for

programmable parameters used in the automatic protocol can be altered by

your Medical Director if desired.

The setup parameters in the following table are used to define the automatic

patient care protocol used by the FR2+. Many of these parameters interact

with each other, so it is very important to understand how each parameter

affects the protocol. The description of each parameter identifies any

interacting parameters in boldface type.

parameter

settings

default

description

shock series

1, 2, 3, 4

Sets the number of shocks that must be delivered to

activate an automatic CPR pause.

The length of the CPR pause after completion of a Shock

Series is defined by the CPR Timer setting.

A new Shock Series begins when a shock is delivered:

•

after the FR2+ is turned on

after the automatic CPR pause, or

after the Pause Key (if enabled) has been pressed, or

if the time since the previous shock exceeds the

Protocol Timeout setting.

protocol

timeout

(minutes)

0.5, 1.0, 1.5, 2.0,

2.5, 3.0, 3.5,

∞ (infinite)

1.0

Sets the time interval used to determine if a delivered

shock should be counted as part of the current Shock

Series.

CPR timer

(minutes)

0.5, 1.0, 1.5,

2.0, 2.5, 3.0

Sets the length of the CPR pause period* that

automatically starts when:

•

a Shock Series is completed; or

the Pause Key (if enabled) is pressed; or

a No Shock Advised (NSA) decision is made, the NSA

CPR pause is enabled, and the conditions for using the

CPR Timer setting for the NSA CPR pause period are

met (see NSA Action).

After the CPR pause, the FR2+ returns to automatic

rhythm analysis.

* The CPR pause period is lengthened by 10 seconds to

allow time for initial voice prompting.

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parameter

settings

default

description

NSA action

(minutes)

MONITOR,

0.5, 1.0, 1.5,

2.0, 2.5, 3.0

Sets how the FR2+ behaves following a NO SHOCK

ADVISED (NSA) decision:

MONITOR

MONITOR — directs the FR2+ to monitor the patient’s

ECG following an NSA decision and to prompt the user

periodically to provide CPR. The interval for CPR

prompting is set by the Monitor Prompt Interval.

TIME SETTING — directs the FR2+ to provide a CPR

pause period following an NSA decision (NSA CPR

Pause).

•

If no shocks have been delivered in the current Shock

Series (e.g., the patient’s initial monitored rhythm is

non-shockable), the length of the CPR pause is defined

by the NSA Action time setting.

•

If shocks have been delivered in the current Shock

Series (e.g., the NSA decision follows a shock), the

length of the CPR pause is instead defined by the CPR

Timer setting.

CPR prompt

Sets the level of detail provided in the CPR reminder voice

prompts provided at the completion of a Shock Series.

LONG, SHORT

LONG

LONG — provides detailed coaching to check airway,

breathing, and pulse before beginning CPR.

SHORT — simply directs user to begin CPR if needed.

monitor prompt

interval

(minutes)

1.0, 1.5, 2.0,

2.5, 3.0,

∞ (infinite)

1.0

Sets the interval for patient care prompts provided during

FR2+ monitoring of the patient’s ECG following an NSA

decision. Selection of ∞ (infinite) means that no repeat

prompting will be provided during ECG monitoring.

Setup and Advanced Mode Features

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Manual override parameters

The HeartStart FR2+ provides several ways of overriding the automatic

protocol. The parameters in the following table are used to enable different

kinds of manual override.

parameter

advanced

settings

default

description

Enables or disables advanced mode entry for ALS or

tiered-response systems.

OFF,

ANALYZE,

CHARGE

OFF

OFF — disables advanced mode features.

ANALYZE — enables user-initiated rhythm analysis and

disarm, and (M3860A only) automatically turns on ECG

display when advance mode is entered.

CHARGE (M3860A only) — in addition to enabling the

analyze feature, enables user-initiated charging and

disarming.

pause key

OFF,

MONITOR,

ALWAYS

Enables or disables user-initiated CPR pause in the

automatic protocol. The length of the pause is defined by

the CPR Timer setting. When an Advanced mode feature

(ANALYZE or CHARGE) is enabled and accessed, the

Pause key is disabled.

OFF

OFF — disables availability of user-initiated pause.

MONITOR — enables user-initiated pause only during FR2+

monitoring of patient rhythm.

ALWAYS — enables user-initiated pause any time except

when the device is already paused.

If enabled, the Pause Key

is accessed by pressing

the lower Option button

indicated by an arrow on

the FR2+ display, as

shown in the sample

screen:

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parameter

settings

default

description

resume key

Enables (ON) or disables (OFF) user-initiated interruption

of the CPR pause and return to analyzing. If either the

CPR Timer or the NSA Action setting is programmed to

1.5 minutes or longer, the Resume Key setting is

automatically enabled (ON).

ON, OFF

OFF

If enabled, the Resume

Key is accessed by

pressing the lower Option

button indicated by an

arrow on the FR2+

display, as shown in the

sample screen:

advanced use

prompt

0.5, 1.0, 1.5,

2.0, 2.5, 3.0

0.5

Sets the interval for “Press to Analyze” prompts provided

during advanced mode operation.

interval

(minutes)

Using Setup Features

NOTE: To move around the menus displayed, use the Option buttons as

follows:

•

Press the LOWER Option button to move the highlight bar from one

item to another on the menu.

•

Press the UPPER Option button to select the highlighted item or to

scroll through the settings for that item.

The FR2+ comes with a factory default setup designed to meet the needs of

most users. The setup feature of the FR2+ lets you review the current setup

of your HeartStart FR2+ or install a revised setup if appropriate. To go to the

SETUP menu:

1. Remove and reinstall the battery to bring up the first menu on the screen.

NOTE: This screen will not be displayed if the FR2+ is connected to

defibrillator pads (that are applied to the patient) when the battery is

inserted, and you will not be able to access the menu items. In addition,

the battery insertion selftest and periodic automatic selftests cannot run

while the defibrillator pads are connected. Be sure to unplug the pads

connector from the FR2+ after each use. Do not store the FR2+ with

the pads connected.

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6-6

2. Within 10 seconds of installing the battery, press the lower Option

button to move the highlight bar to NEXT.

3. Press the upper Option button to select NEXT.

4. Press the lower Option button to move the highlight bar to SETUP.

5. Press the upper Option button to bring up the SETUP menu.

The SETUP menu allows you to receive setup directly from another

HeartStart FR2+ or a computer running HeartStart Event Review software,

read setup from a data card, or review current setup.

Reviewing current setup

A good way to understand the setup of your FR2+ is to review the setup it

currently uses.

1. Select REVIEW SETUP from the SETUP menu. The first of a series of

REVIEW SETUP screens is displayed.

2. After reviewing the screen contents, press the upper Option button to

select NEXT and move to the next screen.

3. The last screen allows you to select RETURN and go back to the SETUP

menu.

Revising setup

There are several ways to change the setup of your HeartStart FR2+. All of

them require use of products or accessories available separately from Philips

Medical Systems.

ꢀ

Use the M3864A training & administration pack to enable software

within the FR2+ to modify its setup. (Instructions are provided with the

Pack.)

Read a revised setup from a data card containing the setup. (Instructions

are provided later in this chapter.)

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ꢀ

Use the infrared communications feature of the FR2+ to receive the

revised setup from another FR2+. (Instructions are provided later in this

chapter.)

Use the infrared communications feature of the FR2+ to receive the

revised setup from a computer running HeartStart Event Review

software. (Instructions are provided with the HeartStart Event Review

software.)

CAUTION: Alteration of the factory default setup of the FR2+ can affect its

performance and should be performed under the authorization of your

Medical Director. Modifications to device operation resulting from changes to

the default settings should be specifically covered in user training.

See the tables describing the various setup parameters at the beginning of

this chapter and Appendix D, “Glossary of Terms,” for definitions of setup

items.

Receiving setup

This method uses the infrared communications feature of the HeartStart

FR2+ to receive setup directly from one HeartStart FR2+ to another (which

must have the training & administration pack installed in it) or from a

computer running HeartStart Event Review software. (See instructions

provided with HeartStart Event Review.) To receive setup from another

FR2+, follow these steps:

1. Locate the infrared communications port on each HeartStart FR2+ and

line them up with one another, so that the infrared “eye” in each one has

an uninterrupted view of the “eye” in the other. (See the diagram on the

inside front cover.) The two devices should be no more than 1 meter

apart.

2. Make sure the “sending” FR2+ has the training & administration pack

installed and is ready to send. (See the M3864A training &

administration pack Reference Guide for instructions.)

3. Select RECEIVE SETUP from the setup menu:

4. A new screen comes up. Until the two HeartStart FR2+ devices are

properly positioned, the screen displays READY TO RECEIVE and

prompts you to check the sending FR2+.

5. Setup data are automatically transferred as soon as the infrared ports

are correctly aligned.

6. If you select EXIT before the transfer is complete, the revised setup will

not be received. When the transfer is complete, the screen on the

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6-8

“receiving” FR2+ displays a SETUP COMPLETE message. Your

HeartStart FR2+ immediately uses the new setup.

Receiving setup from a computer running HeartStart Event Review software

is discussed in the directions for use provided with HeartStart Event Review

software.

Reading setup

This method copies setup data from a data card to your HeartStart FR2+. To

read the setup, follow these steps:

1. Insert the data card in the data card tray and install the loaded tray into

the data card slot in the FR2+.

2. Select READ SETUP from the setup menu.

3. A new screen comes up. If the FR2+ cannot read the data card or

cannot find a valid setup on the data card, the screen displays a NO

SETUP FILE error message. Otherwise, the FR2+ begins reading the

setup information from the data card immediately.

4. If you select EXIT before the transfer is complete, the revised setup will

not be copied. When the transfer is finished, the screen displays a

SETUP COMPLETE message. Your FR2+ immediately uses the revised

setup.

Sending and Receiving Clock Settings

To synchronize the clock settings of your HeartStart FR2+ with the clock of

another FR2+ or a computer running HeartStart Event Review software, you

can use the infrared communications feature.

Instructions for synchronizing clock settings using a computer running

HeartStart Event Review are provided with the HeartStart Event Review

software.

To transfer clock settings from one FR2+ to another:

1. Remove and reinstall the battery of both FR2+ devices to bring up the

first menu screen.

2. Select NEXT to go to the second menu screen.

3. Select CLOCK from the second menu screen. The CLOCK screen then

comes up.

4. Locate the infrared communications port on each FR2+ and line them up

with one another, so that the infrared “eye” in each one has an

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uninterrupted view of the “eye” in the other. (See the diagram on the

back of the first page of this manual.) The two devices should be no

more than 1 meter apart.

5. Select SEND TIME from the CLOCK screen on the “sending” HeartStart

FR2+.

6. Select RECEIVE TIME from the CLOCK screen of the “receiving” FR2+.

7. A new screen comes up. Until the two FR2+ devices are properly

positioned, the screen on the receiving FR2+ displays READY TO

RECEIVE and prompts you to check the sending FR2+. The screen on

the sending FR2+ displays READY TO SEND and prompts you to check

the receiving FR2+.

8. Clock settings are automatically transferred as soon as the infrared ports

are correctly aligned.

Using Advanced Mode Features

The HeartStart FR2+ provides an advanced mode that allows responders

who are appropriately trained to override the programmed FR2+ protocol

and take responsibility for certain aspects of the operating sequence used by

the FR2+ to treat the patient.

As described earlier in this chapter, the factory default setup of the FR2+

must be modified to provide access to advanced mode features. This

requires use of the administration function of the M3864A training &

administration pack.

If you are an expert user authorized by your Medical Director to modify setup,

hold down both the Option buttons while installing the training &

administration pack in the FR2+, then select SETUP. Then select MODIFY

SETUP from the SETUP menu. Select ADVANCED from the third menu of the

MODIFY SETUP menu.

Using the upper Option button, scroll through the available settings for

ADVANCED. The advanced mode options available are based on the FR2+

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model used. For the M3860A, the user can select ANALYZE, CHARGE, or

OFF. For the M3861A the user can select only ANALYZE or OFF. (Detailed

directions for use are supplied with the training & administration pack.)

CAUTION: Alteration of the factory default setup of the FR2+ can affect its

performance and should be performed under the authorization of your

Medical Director. Modifications to device operation resulting from changes to

the default settings should be specifically covered in user training.

CAUTION: The HeartStart FR2+ advanced mode’s MANUAL CHARGE

feature is intended for use only by authorized operators who have been

specifically trained in cardiac rhythm recognition and in defibrillation therapy

using manual charge and shock delivery.

The ANALYZE feature is particularly useful for organizations that include

responders who have Basic Life Support (BLS) training as well as more

highly trained responders who may be certified in Advanced Life Support

(ALS). In such situations, the Medical Director may set up a

“tiered-response” system. The HeartStart FR2+ is specifically designed to

provide different product features appropriate to each tier of responder.

In a scenario where a BLS responder is the first on the scene of an incident,

he or she is trained to treat the patient immediately — for example, to check

for breathing and responsiveness; to apply the defibrillator pads and connect

them to the HeartStart FR2+; and to follow the voice and text prompts

provided by the HeartStart FR2+ in its automated (AED) mode. When an

ALS-trained responder arrives, the BLS responder “hands off” the patient’s

care to the more highly trained responder.

Because these second-tier responders have advanced training and

developed clinical skills, they may be authorized to access the advanced

mode features of the HeartStart FR2+. These include user-initiated analysis

and manual charge and disarm control.

Using the manual analyze feature

The Manual Analyze feature is available in both the M3860A and the

M3861A models, when enabled in setup.

To enter the advanced mode during use of an FR2+ that has this feature

enabled, press both Option buttons simultaneously. This brings up a screen

that includes a highlighted line at the bottom, labeled ANALYZE, with an

arrowhead pointing to the lower Option button.

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In the M3861A HeartStart FR2+, the patient’s ECG is not displayed; in the

M3860A, the display includes the patient’s ECG and heart rate.

Press the lower Option button (ANALYZE) to initiate rhythm analysis by the

FR2+. If a shock is advised, the FR2+ automatically charges, and prompts

you to press the Shock button.

After shock delivery, the HeartStart FR2+ returns to the advanced mode

display and monitors the patient’s heart rhythm. If a potentially shockable

rhythm is detected, the text and voice prompts advise you to PRESS

ANALYZE.

NOTE: If you do not press the lower Option button (labeled ANALYZE) to

initiate rhythm analysis when prompted, the HeartStart FR2+ does not

analyze and prompt if a shock is advised. It is important that you understand

that entering the advanced mode entails taking responsibility for these

functions.

If the rhythm analysis results in a Shock Advised decision, the FR2+ begins

charging, prompts you to press the Shock button, and displays a MANUAL

DISARM option at the top of the screen. If for any reason you want to cancel

the shock, press the upper Option button to disarm the FR2+.

To return to non-manual, AED mode operation, turn the FR2+ off by pressing

the On/Off button. Then turn the FR2+ on by pressing the On/Off button

again.

Using the manual charge feature (M3860A only)

The manual charge feature is available only in the M3860A, when enabled in

setup.

To enter the advanced mode during use of an FR2+ that has this feature

enabled, press both Option buttons simultaneously. This brings up a screen

that includes a highlighted line at the top, labeled MANUAL, with an

arrowhead pointing to the upper Option button, and another at the bottom,

labeled ANALYZE, with an arrowhead pointing to the lower Option button.

When the advanced mode is entered, display of the patient’s ECG and heart

rate is automatically initiated.

Pressing the lower Option button (ANALYZE) provides user-initiated rhythm

analysis as described above. Pressing the upper Option button (MANUAL)

brings up a new screen.

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The highlighted top line is labeled MANUAL CHARGE, with an arrowhead

pointing to the upper Option button.

If the ECG display shows that, in your expert clinical judgment, the patient

has a shockable rhythm, press the upper Option button (MANUAL CHARGE).

The HeartStart FR2+ will immediately charge for shock delivery.

As soon as charging begins, the screen message changes to CHARGING,

STAND CLEAR, and the label for the arrowhead pointing to the upper Option

button changes to MANUAL DISARM.

The FR2+ beeps while it is charging. When the beeping changes to a

continuous tone and the Shock button light flashes, press the Shock button

to deliver a shock. However, if the ECG display shows that the patient’s

rhythm has changed to a non-shockable rhythm, press the upper Option

button to disarm the HeartStart FR2+.

After shock delivery, the HeartStart FR2+ returns to the initial advanced

mode screen. To return to non-manual, AED mode operation, turn the FR2+

off by pressing the On/Off button. Then turn the FR2+ on by pressing the

On/Off button again.

M3860A/M3861A HEARTSTART FR2+

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Data Management and Review

Overview

The HeartStart FR2+ is designed to make it easy to manage incident data.

Some information is automatically stored in the internal memory of the

HeartStart FR2+. More detailed data can be stored on a data card if desired.

The incident information stored in the HeartStart FR2+’s internal memory, or

a summary of the information recorded on the data card, can then be

displayed on the HeartStart FR2+ screen for review. In addition, HeartStart

Event Review* software can be used on a personal computer to store and

review the detailed recorded information from a data card.

Recording Incident Data

The HeartStart FR2+ has two ways of recording information about an

emergency incident so that it can be reviewed after the incident: in internal

memory and on an optional data card.

Recording data in internal memory

Summary data for an incident is automatically recorded in internal memory by

the FR2+ while you are using it.

Recording data on a data card

The M3854A data card can be used to store several hours of detailed

incident data, including events and ECG.

IMPORTANT NOTE: To record incident data on a data card, the data card

must be installed before you turn on the FR2+.

CAUTION: The FR2+ is designed to be used only with Philips-approved

accessories. The FR2+ may perform improperly if non-approved accessories

are used.

HeartStart Event Review software was previously sold as CodeRunner software.

7-1

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7-2

To install a data card:

1. Make sure the data card is clean and dry.

2. Load the data card into its plastic tray, with the tray’s “tongue” fitting

over the matching yellow area on the data card. The label on the card

should face up. The label has an arrow indicating which side to insert

into the data card port.

3. Make sure the FR2+ is off (in standby mode), or that the battery has

been removed.

4. Hold the loaded tray by its handle and gently insert the tray into the data

card port on the right side of the FR2+. Push the tray all the way into the

port until only the tab remains outside the FR2+ case. Do not force the

tray into the port. If the tray is hard to insert, remove it and make sure that

the arrow label is face up and pointing toward the data card port.

The data card will automatically record incident data the next time the

HeartStart FR2+ is turned on.

To avoid running out of data card space during an incident, it is

recommended that each data card be used to record the information for only

one incident and that it be replaced after each use of the FR2+.

If you record information from more than one incident on a data card, it is

important to review how much time is left on the used data card before

recording a new incident. To do this, load the data card into the data card

tray, insert the tray in the FR2+, then remove and reinstall the battery. The

first screen displayed shows how much recording time remains on the card.

NOTE: During an incident, if for any reason you turn off the FR2+ for less

than five minutes, the FR2+ considers this to be a “continued use” situation,

and:

•

the information stored about the incident is saved,

additional events recorded after the device is turned back on will be

treated as part of the same incident, and

•

the selftest will not automatically run if the battery is replaced.

IMPORTANT NOTE: Do not remove the battery while incident data are

being recorded to a data card. To ensure that no incident data are lost, turn

the FR2+ off (return it to standby mode) before replacing the battery.

M3860A/M3861A HEARTSTART FR2+

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7-3

To replace a data card:

IMPORTANT: You must turn the FR2+ off (return it to standby mode) before

you remove the data card, to ensure that no incident data are lost.

1. Press the On/Off button to turn off the FR2+. Never replace the data

card unless the FR2+ is turned off.

2. Remove the loaded data card tray by grasping its handle and pulling it

out of the port.

3. Remove the data card from the tray.

4. Give the data card to the appropriate person in your organization.

5. Because it helps seal the FR2+ against moisture, the data card tray

should always be reinserted into the port of the FR2+. Either load a new

data card into the tray and insert it, or insert the empty data card tray into

the port.

Reviewing Incident Data

Reviewing data from internal memory

Summary information from the last incident that is stored in the internal

memory of the HeartStart FR2+ can be displayed on its screen for review. To

review this information:

1. Remove the data card if one is installed and unplug the pads connector.

2. Remove and reinstall the battery. (Make sure you are using the gray

M3863A FR2 standard battery or the blue M3848A rechargeable

battery, not the yellow training & administration pack.)

3. Select REVIEW INCIDENT from the menu. A new screen comes up.

4. Observe and record, if desired, the summary information displayed on

the screen:

ꢀ

how long the incident recorded by the FR2+ lasted, and

how many shocks were delivered during the incident.

ꢀ

This information stays in the FR2+’s memory and can be displayed for review

until the next time the FR2+ is used. At that time, the data from the new

incident will be displayed.

Data Management and Review

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7-4

Reviewing data from a data card

If a data card is installed when the HeartStart FR2+ is turned on for use

during an incident, the HeartStart FR2+ automatically records detailed

information on the data card. To review this information on the HeartStart

FR2+ screen:

1. Make sure the training & administration pack is not installed.

2. Make sure the data card is installed. Unplug the pads connector.

3. Remove and reinstall the battery.

4. Select REVIEW INCIDENT from the menu. A new screen comes up. This

screen displays:

ꢀ

ELAPSED TIME — how long the incident recorded by the FR2+

lasted,*

SHOCKS DELIVERED — how many shocks were delivered during the

incident, and

FIRST SHOCKS AT — the times at which the first three shocks were

delivered.

NOTE: If the data card does not contain event data, only the summary

information from FR2+ internal memory will be displayed when REVIEW

INCIDENT is selected.

5. To review the events that occurred during the incident, select REVIEW

EVENTS. A new screen comes up. This and following screens, accessed

by selecting NEXT EVENTS, display elapsed time information for critical

activities in using the FR2+. These include:

ꢀ

POWER ON — when the FR2+ was turned on,

PADS ON — when the defibrillator pads were connected,

SHOCK ADVISED — when a shock was advised,

ARMED — when the FR2+ charged for shock delivery,

SHOCKED — when a shock was delivered,

SHOCK ABORTED — when a shock was aborted,

PAUSE FOR CPR — when a pause occurred

POWER OFF — when the FR2+ was turned off

The FR2+ displays elapsed time to a maximum of 99:59 minutes. If the elapsed time of use

extends beyond this figure, the minutes are represented by “??” but the seconds are

displayed. However, total elapsed time will be recorded on an installed data card for later

review with HeartStart Event Review data management software.

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7-5

Additional information may be displayed if your FR2+ is using a revised setup

allowing advanced mode operation.

6. To review the first six seconds of the recorded presenting ECG for the

incident, select REVIEW ECG. A new screen comes up. This screen

displays a three-second segment of the presenting ECG from the

incident.

7. Select NEXT ECG SEGMENT to review the second three-second segment

of the presenting ECG.

Data cards can be reused if desired. Using a personal computer running

HeartStart Event Review software, you can copy the information from a data

card, then erase the card and reuse it in the FR2+.

Data Management and Review

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Notes

M3860A/M3861A HEARTSTART FR2+

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A Accessories for the HeartStart FR2+

HeartStart Accessories

Accessories for the HeartStart FR2+ available separately from Philips

Medical Systems include the following:

ꢀ

Spare M3863A FR2 standard battery (recommended)

DP2/DP6 adult defibrillator pads

M3870A FR2 infant/child reduced-energy defibrillator pads

Spare M3853A data card tray

M3854A data card and tray

M3868A fabric carrying case

M3869A vinyl carrying case

M3857A wall mount bracket

M3848A FR2+ rechargeable battery^{* †}

M3849A charger, for the M3848A FR2+ rechargeable battery only;

includes power cord

ꢀ

68-PCHAT fast response kit (pouch containing a pocket mask, a

disposable razor, 2 pairs of gloves, a pair of paramedics scissors, and an

absorbent wipe)

M3873A/M3874A FR2+ ECG assessment module, for use only with an

M3860A FR2+ configured for ECG display, for connection to ECG

electrodes per AAMI (M3873A) or IEC (M3874A) convention^†

ꢀ

M3864A training & administration pack

M3855A charger, for the training & administration pack only; includes

power cord

ꢀ

PFE7023D/PFE7024D defibrillator cabinets

07-10900 training pads^‡

YC hardshell waterproof carrying case

The M3848A FR2+ rechargeable battery is designed for environments in which the FR2+

Defibrillator is expected to see frequent use. This battery is not designed for use in aircraft.

It is recommended that this battery not be used as a spare or backup battery and, due to its

shorter standby life, that it not be used as the primary or spare battery in applications

where the FR2+ Defibrillator is infrequently used, such as the home, commercial business,

or commercial airlines environments.

†

‡

These products can be used only with FR2+ Defibrillators running software version 1.5 or

higher.

IMPORTANT: Never store training pads with the defibrillator.

A-1

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A-2

Suggested Additional Items

It may be useful to keep some additional items with your HeartStart FR2+ for

use if needed when an incident occurs. Some suggested supplies include:

ꢀ

a pair of paramedic’s shears or scissors^*

a disposable razor designed for removing chest hair^*

a pocket mask or face shield^*

disposable gloves^*

a towel or antiseptic wipes^*

a source of oxygen

Your medical director may have other requirements for supplies.

Contained in the fast response kit available from Philips Medical Systems

M3860A/M3861A HEARTSTART FR2+

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B Technical Specifications

The specifications for the HeartStart FR2+ provided in this chapter apply to

both the M3860A and M3861A, unless otherwise noted. Additional

information can be found in the Technical Reference Manual for the FR2

Defibrillator, located online at www.medical.philips.com.

HeartStart FR2+ Defibrillator Specifications

Physical

category

nominal specifications

Size

2.6" high x 8.6" wide x 8.6" deep (6.6 cm x 21.8 cm x 21.8 cm).

Weight

Approximately 4.7 lbs (2.1 kg) with M3863A FR2 standard battery installed.

Approximately 4.5 lbs (2 kg) with optional M3848A FR2+ rechargeable battery

installed.

Environmental

category

nominal specifications

Operating Temperature

and Humidity

32° to 122° F (0° to 50° C).

0% to 95% relative humidity (non-condensing).

Standby Temperature

and Humidity

32° to 109° F (0° to 43° C).

0% to 75% relative humidity (non-condensing).

Applies to HeartStart FR2+ with battery installed and stored with defibrillator

pads.

Altitude

Meets MIL-810E 500.3, Procedure II (-500 feet to 15,000 feet).

Shock/Drop Abuse

Tolerance

Meets MIL-STD-810E 516.4, Procedure IV (after a 1 meter drop to any edge,

corner, or surface, in standby mode).

Vibration

Sealing

Meets MIL-STD-810E 514.4-17.

With data card tray and battery installed, meets IEC 529 class IP54.

Meets EN 61000-4-2:1998 Severity Level 4.

ESD

EMI (Radiated)

Meets EN 60601-1-2 limits (1993), method EN 55011:1998 Group 1 Level B.

B-1

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B-2

category

EMI (Immunity)

nominal specifications

Meets EN 60601-1-2 limits (1993), method EN 61000-4-3:1998 Level 2 (3 V/m

and 10 V/m at 26 MHz to 1 GHz).

Aircraft: Method

Meets RTCA/DO-160D:1997 Section 21 (Category M - Charging).

Defibrillator

category

Waveform Parameters

nominal specifications

Biphasic truncated exponential. Waveform parameters are automatically adjusted as a

function of patient defibrillation impedance. In the diagram at left, A is the duration of phase

1 and B is the duration of phase 2 of the waveform, C is the interphase delay, V_pis the peak

voltage, and V_fthe final voltage.

The HeartStart FR2+ delivers shocks to load impedances from 25 to 180 ohms.

The duration of each phase of the waveform is dynamically adjusted based on

delivered charge, in order to compensate for patient impedance variations, as

shown below:

adult defibrillation

load

phase 1

phase 2

duration (ms)

delivered

energy (J)

resistance (ohms) duration (ms)

100

125

150

2.8

4.09

9.0

2.8

4.09

6.0

140

150

157

161

157

12.0

8.0

pediatric defibrillation

(using M3870A FR2 infant/child reduced-energy defibrillator pads)

load

phase 1

phase 2

duration (ms)

delivered

energy (J)

resistance (ohms) duration (ms)

100

125

150

4.1

5.8

7.2

9.0

4.1

3.8

4.8

6.0

NOTE: The values given are nominal. Because of the effect of the M3870A FR2

infant/child pads’ attenuation circuitry on the defibrillator’s impedance

compensation feature, the actual phase durations for a given load resistance on

the table above could be those of an adjacent row.

M3860A/M3861A HEARTSTART FR2+

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B-3

category

nominal specifications

Energy

Using adult defibrillator pads: 150 J nominal into a 50 ohm load.

Using infant/child reduced-energy defibrillator pads: 50 J nominal into a 50 ohm

load. Sample pediatric energy doses:

age

energydose

newborn

1 year

2 − 3 years

4 − 5 years

6 − 8 years

14 J/kg

5 J/kg

4 J/kg

3 J/kg

2 J/kg

Doses indicated are based on CDC growth charts for the 50th percentile weights

for boys.*

National Center for Health Statistics in collaboration with the National Center for

Chronic Disease Prevention and Health Promotion. CDC growth charts:

weight-for-age percentiles, revised and corrected November 28, 2000. Atlanta,

Charge Control

Controlled by Patient Analysis System for automated operation. Can be

programmed for manual initiation using advanced mode of the M3860A.

Charge Time

from “Shock Advised”

< 10 seconds typical, including confirming analysis. Charge time increases near

end of battery service life.

Shock-to-Shock Cycle Time < 20 seconds typical, including analysis, in AED mode.

“Charge Complete”

Indicator

Shock button flashes, audio tone sounds.

Disarm (AED mode)

Once charged, the HeartStart FR2+ will disarm if:

•

patient’s heart rhythm changes to non-shockable rhythm, OR

a shock is not delivered within 30 seconds after the FR2+ is armed, OR

the PAUSE button (if enabled) is pressed, OR

the On/Off button is pressed to turn off the FR2+, OR

the defibrillator pads are removed from the patient or the pads connector is

disconnected from the FR2+.

Technical Specifications

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B-4

category

Disarm (advanced mode)

nominal specifications

Once charged, the HeartStart FR2+ will disarm if:

in advanced mode ANALYZE

•

the manual disarm button is pressed, OR

a patient’s heart rhythm changes to non-shockable rhythm, OR

a shock is not delivered within 30 seconds after the FR2+ is armed, OR

the On/Off button is pressed to turn off the FR2+, OR

the defibrillator pads are removed from the patient, OR

the pads connector is disconnected from the FR2+.

in advanced mode CHARGE (M3860A only)

•

the manual disarm button is pressed, OR

a shock is not delivered within 30 s after charging, OR

the On/Off button is pressed to turn off the FR2+, OR

the defibrillator pads are removed from the patient, OR

the pads connector is disconnected from the FR2+.

Shock Delivery Vector

Via adult defibrillator pads placed in the anterior-anterior (Lead II) position or via

FR2 infant/child reduced-energy defibrillator pads placed in the anterior-posterior

position.

ECG Analysis System

category

nominal specifications

Function

Evaluates impedance of defibrillator pads for proper contact with patient skin, and

evaluates the ECG rhythm and signal quality to determine if a shock is appropriate.

Protocols

Follows pre-programmed settings to match local EMS guidelines or medical

protocols. The settings can be modified using the setup options.

Shockable Rhythms

Ventricular fibrillation (VF) and certain ventricular tachycardias, including

ventricular flutter and polymorphic ventricular tachycardia (VT). The HeartStart

FR2+ uses multiple parameters to determine if a rhythm is shockable.

NOTE: For safety reasons, some very low-amplitude or low-frequency rhythms

may not be interpreted as shockable VF rhythms. Also, some VT rhythms may not

be interpreted as shockable rhythms. CPR rates significantly above 100

compressions per minute can cause incorrect or delayed analysis by the

HeartStart FR2+.

Asystole

On detection of asystole, provides CPR prompt at programmed interval.

M3860A/M3861A HEARTSTART FR2+

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B-5

category

nominal specifications

Pacemaker Detection

On detection of a pacemaker (in advanced mode or with M3873A/M3874A FR2+

ECG assessment module), provides screen display of PACEMAKER DETECTED

alert. M3860A includes pacemaker artifact in ECG display. In both models,

pacemaker artifact is removed from the signal for rhythm analysis.

Display

category

nominal specifications

Monitored ECG Lead

ECG information is received from adult defibrillator pads in anterior-anterior (Lead

II) position or from FR2 infant/child reduced-energy defibrillator pads in

anterior-posterior position. (Displayed on M3860A only.)

ECG information can also be displayed in the M3860A using the FR2+ ECG

assessment module.

NOTE: The ECG display provided by the FR2+ Defibrillator is not is not

intended to provide diagnostic or ST segment interpretation.

Display Range

(M3860A only)

Differential: 2 mV full scale, nominal.

Screen Type

High-resolution liquid crystal display (LCD) with backlight.

2.8" wide x 2.3" high (70 mm x 58 mm).

23 mm/s nominal.

Screen Dimensions

Sweep Speed

(M3860A only)

ECG Display

3 second-segments displayed (M3860A only).

Frequency Response

(Bandwidth)

Nondiagnostic rhythm monitor 1 Hz to 20 Hz (-3 dB), nominal.

Sensitivity

1.16 cm/mV, nominal.

Heart Rate Displayed

(Normal Sinus Rhythm)

30 to 300 bpm, updated each analysis period. Displayed (M3860A only) during

monitoring and advanced modes.

Controls and indicators

category

nominal specifications

LCD Screen

High-resolution, backlighted LCD screen, displays text messages and (model

M3860A only) ECG.

Technical Specifications

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B-6

category

nominal specifications

Controls

On/Off button

Shock button

Option buttons

LED Indicators

Connector socket LED, flashes to indicate socket location. LED is covered when

defibrillator pad connector is properly inserted. Shock button LED flashes when

defibrillator is armed.

Audio Speaker

Beeper

Provides voice prompts (volume is adjustable via Setup screen).

Chirps when a selftest has failed.

Provides various warning beeps during normal use.

Status Indicator

Status indicator LCD displays device readiness for use.

Automatic during daily periodic selftesting.

Low Battery Detection

Low Battery Indicator

Solid or flashing red X Status Indicator on front panel; screen display LOW

BATTERY or REPLACE BATTERY warning, as appropriate.

Accessories Specifications

M3863A FR2 standard battery

category

nominal specifications

Battery Type

Capacity

12 VDC, 4.2 Ah, lithium manganese dioxide. Disposable, long-life primary cell.

When new, a minimum of 300 shocks or 12 hours of operating time at 77° F

(25° C).

Shelf Life

(prior to installation)

Typically, 5 years from date of manufacture when stored under standby

environmental conditions in original packaging.

Standby Life

(after installation)

Typically, 5 years. >4 years when stored under standby environmental conditions

(battery installed, FR2+ unused).

Status Indicators

Good battery: flashing black hourglass on the front panel of the FR2+.

Low battery: flashing red X on the front panel of the FR2+.

Dead battery: solid red X on the front panel of the FR2+.

Storage Temperature

32° to 109° F (0° to 43° C).

M3860A/M3861A HEARTSTART FR2+

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B-7

(Optional) M3848A FR2+ rechargeable battery

category

Battery Type

nominal specifications

11.3 VDC, 6.5 Ah, lithium ion. Rechargeable cell using the M3849A charger.

When freshly charged and used at 77° F (25° C) , provides a minimum of 80

Capacity

(typically 100) shocks, or 3.5 hours (typically 5 hours) of ECG display time only,

before recharging is indicated.

Status Indicators

Good battery: bar graph on display screen indicating remaining power level.

Low battery: flashing red X on the front panel of the FR2+ (When low battery

indicator appears, there is still enough energy to deliver 9 shocks plus 15 minutes

of ECG display time).

Dead battery: solid red X on the front panel of the FR2+.

Storage Temperature

32° to 109° F (0° to 43° C).

Standby Life

6 months when installed fully charged in a defibrillator labeled FR2+.

(after installation)

(Optional) M3849A charger

category

nominal specifications

Application

For use with M3848A FR2+ rechargeable battery only.

100 to 240 VAC, 47 to 63 Hz, 30 Watts

Power Requirements

Environmental

Requirements

32° to 122° F (0° to 50° C).

0% to 95% relative humidity (non-condensing).

Conformance Testing

International: EN60335-1:1994 Class 1

North America: UL 1310 Class 2

M3870A and DP2/DP6 defibrillator pads

category

nominal specifications

Pads, Cable, and Connector Disposable and self-adhesive. DP2/DP6 adult defibrillator pads have a nominal

active surface area of 100 cm each and are provided in a sealed package with an

integrated 122 cm (48 inch), typical, cable and connector. M3870A FR2

infant/child reduced-energy defibrillator pads have a nominal active surface area of

44 cm each and are provided in a sealed package with an integrated 122 cm (48

inch), typical, cable and connector incorporating attenuating electronics.

Technical Specifications

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B-8

category

nominal specifications

Defibrillator Pad

Requirements

Use only DP2/DP6, M3870A, M3713A, and M3716A defibrillator pads with the

HeartStart FR2+. Place the pads on the patient as illustrated on each pad.

(Optional) M3854A data card

category

nominal specifications

Capacity

8 hours of event and ECG data, or 60 minutes with voice recording.

(Optional) M3864A training & administration pack

category

nominal specifications

Battery Type

12 V, 1.1 Ah, nickel metal hydride. Disposable, rechargeable cell using the

M3855A charger.

Capacity

Provides 4 hours of operating time at 77 °F (25 °C).

Status Indicators

Low battery: flashing red X on the front panel of the FR2+.

Dead battery: solid red X on the front panel of the FR2+.

Storage Temperature

50° to 104° F (10° to 40° C).

(Optional) M3855A charger

category

nominal specifications

Application

For use with M3864A training & administration pack only.

Power Requirements

With appropriate power cord, any AC mains power input or inverter-type power

sources.

Environmental

Requirements

32° to 113° F (0° to 45° C).

35% to 85% relative humidity (non-condensing).

Conformance Testing

International: EN60335-1:1994 Class I

North America: UL 1310 Class 2

M3860A/M3861A HEARTSTART FR2+

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B-9

(Optional) M3873A/M3874A FR2+ ECG assessment

module

category

Application

nominal specifications

For use with the FR2+ M3860A with ECG display enabled and running version

1.5 software or higher (denoted by FR2+ on the front panel or rear label).

Length and Weight

100 inches (182 cm); ≤ 1 lb. (2.2 kg).

Operating Temperature and

Humidity

32° to 122° F (0° to 50° C);

0% to 95% relative humidity (non-condensing).

Storage Temperature and

Humidity

32° to 109° F (0° to 43° C).

0% to 75% relative humidity (non-condensing).

Patient Lead Wire

Designation

M3873A (AAMI):

positive lead − red

M3874A (IEC):

positive lead − green

negative lead − white

negative lead − red

reference lead − black.

reference lead − yellow

Typical (Lead II) Connection Lead II vectors:

positive − left leg

negative − right arm

reference − left arm.

Other limb vectors can be obtained by different electrode positions.

Battery Type

Service Life

3 V, 1 Ah, poly-carbonmonofluoride lithium (LiCFx). Non-replaceable disposable

primary cell.

Typically, 5 years.

Performance with FR2+

Defibrillator

Meets environmental specifications cited for FR2+ Defibrillator on page B1

through B2.

Technical Specifications

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Notes

M3860A/M3861A HEARTSTART FR2+

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C Glossary of Symbols and Controls

Instructions for Use

symbol

description

Meets the requirements of the European medical device

directives.

Printed on recycled paper.

HeartStart FR2+ M3860A and M3861A

Defibrillator Symbols and Controls

Control panel and back label

symbol

description

On/Off button. Turns the HeartStart FR2+ on or off;

disarms HeartStart FR2+, stops automatic self-test. When

the optional training & administration pack is being used in

the Training function, this button is used to select and exit

training scripts.

Shock button. Delivers shock to patient when the

HeartStart FR2+ is charged.

Upper and lower Option buttons. Allow you to move

around in and select an item from a display menu, provide

adjustment of display screen contrast.

Defibrillation protection. Defibrillation protected, type BF

patient connection.

C-1

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C-2

symbol

description

High voltage.

Refer to operating instructions.

Meets the requirements of the European medical device

directives.

This product has passed relevant safety tests by CSA, a

nationally recognized test lab.

IP54

With data card tray and battery installed, meets IEC 529

class IP54.

HeartStart FR2+ display screen

symbol

description

HR XXX

Heart rate.

Number of shocks delivered.

XX:XX

Time. How much time (minutes:seconds) has passed since

the HeartStart FR2+ was turned on.

Temperature. Recommended storage temperature range

has been exceeded since the last battery insertion

self-test.

TEMPERATURE

SETUP

Setup. Setup has been lost from memory; factory default

setup is being used. Contact Medical Director for revised

setup.

REV: XXX X.X

XXXX

Software. The version of software used in your HeartStart

FR2+.

M3860A/M3861A HEARTSTART FR2+

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C-3

Status indicator

symbol

description

Flashing black hourglass. Ready for use.

Solid red X. Not ready for use. (See Chapter 4,

“Maintaining, Testing, and Troubleshooting Your HeartStart

FR2+.”)

Flashing red X. Troubleshooting required. (See Chapter 4,

“Maintaining, Testing, and Troubleshooting Your HeartStart

FR2+.”)

Accessories Symbols

M3870A and DP2/DP6 defibrillator pads

symbol

description

These pads are disposable and are for single patient use

only.

Pouch contents: one pair of defibrillator pads.

Store the pads at temperatures between 0° and 43° C

(32° and 110° F).

Refer to operating instructions.

Non-sterile.

This product does not contain natural rubber latex.

Glossary of Symbols and Controls

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C-4

symbol

description

Lot number.

Use the pads before the date shown. Date format is

YYYY-MM.

CAUTION: Federal law (USA) restricts this device to sale

by or on the order of a physician.

Pad placement for adults. (DP2/DP6)

For use with Philips Heartstream/HeartStart and Laerdal

HeartStart ForeRunner, FR, and FR2 AEDs. (DP2/DP6)

Not for use with Laerdal HeartStart models 911, 1000,

2000, 3000. (DP2/DP6)

Pad placement for infants and children younger than 8

years or lighter than 55 pounds (25 Kg). (M3870A)

Meets the requirements of the EMC directives. (DP2/DP6)

Meets the requirements of the European medical device

directives. (M3870A)

Box contents = 1 pouch. (M3870A)

M3860A/M3861A HEARTSTART FR2+

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C-5

symbol

description

Box contents = 2 pouches. (DP2)

Box contents = 6 pouches. (DP6)

This side up.

Fragile.

Protect from moisture.

Printed on recycled paper.

M3863A standard battery and

M3848A FR2+ rechargeable battery

symbol

description

Do not crush.

Do not expose to high heat or open flames. Do not

incinerate.

Do not mutilate or open.

Install before the date shown on this label. Date format is

MM-YYYY.

Glossary of Symbols and Controls

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C-6

symbol

description

Refer to operating instructions.

Lithium manganese dioxide battery chemistry (M3863A)

Lithium ion battery chemistry (M3848A)

12 volts direct current output.

Insert into FR2+ in this direction.

Meets the requirements of the European medical device

directives.

Fragile.

Protect from moisture.

Contains one battery.

Printed on recycled paper.

M3849A charger

for the M3848A FR2+ rechargeable battery

symbol description

Refer to operating instructions.

M3860A/M3861A HEARTSTART FR2+

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C-7

symbol

description

High voltage.

Protect from moisture.

On/Off indicator.

Charger status indicator.

Meets the requirements of the EMC directives.

This product has passed relevant safety tests by CSA, a

nationally recognized test lab.

This product has been certified by the Australian

Communication Authority.

N11695

V00341

Printed on recycled paper.

Electrical input.

Electrical output

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C-8

M3873A/M3874A FR2+ ECG assessment module

symbol

description

Use the cable and electrodes before the respective dates

shown on this label.

Ship and store the product within the temperature ranges

shown.

Place the electrodes as shown.

Meets the requirements of the EMC directives.

Lot number.

Refer to operating instructions.

Printed on recycled paper.

M3864A training & administration pack

symbol description

Refer to operating instructions.

M3860A/M3861A HEARTSTART FR2+

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C-9

symbol

description

Do not crush.

Do not expose to high heat or open flames. Do not

incinerate.

Do not mutilate or open.

Nickel metal hydride battery chemistry.

12 volts direct current output.

Insert into FR2+ in this direction.

Meets the requirements of the EMC directives.

Kit contains Training & Administration Pack, Instructions

for Use, and set of training pads.

Ship and store the product within the temperature ranges

shown.

This side up.

Fragile.

Protect from moisture.

Glossary of Symbols and Controls

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C-10

symbol

description

Printed on recycled paper.

M3855A charger

for the M3864A training & administration pack)

symbol description

Refer to operating instructions.

High voltage.

Protect from moisture.

On/Off indicator.

Charger status indicator.

Meets the requirements of the EMC directives.

Electrical input.

Electrical output

Printed on recycled paper.

M3860A/M3861A HEARTSTART FR2+

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D Glossary of Terms

The terms listed in this Glossary are defined in the context of the HeartStart

FR2+ and its use.

advanced mode ..................... A programmable treatment mode that permits an authorized user to control

when the FR2+ starts rhythm analysis and (model M3860A only) when to

begin defibrillator charging for shock delivery.

AED .......................................... Automated external defibrillator.

AED mode ............................... The standard FR2+ treatment mode, with voice and screen prompts guiding

the responder through connecting the defibrillator pads, waiting for rhythm

analysis, and delivering a shock if needed. In this mode, heart rhythm analysis

and monitoring, and shock decision and charging for shock delivery are

automatically performed by the FR2+.

ALS ........................................... Advanced Life Support.

analysis ................................... See “SMART analysis.”

arrhythmia ............................... An unhealthy, often irregular, beating of the heart.

battery ..................................... See “standard battery” and “rechargeable battery.”

BLS ........................................... Basic Life Support.

continued use ........................ A condition in which use of the HeartStart FR2+ is interrupted for less than

five minutes (e.g., for battery replacement). When the battery is reinserted or

the unit is turned on again, the information stored about the interrupted

incident is saved, any additional events recorded after the battery is

reinstalled are treated as part of the same incident, and the selftest does not

automatically run when the battery is reinstalled.

CPR timer ................................ A programmable period provided by the HeartStart FR2+ during which the

responder can administer CPR.

defibrillation ............................ Termination of cardiac fibrillation by applying electrical energy

defibrillation charge .............. Electrical energy stored in the capacitor of the HeartStart FR2+ as it arms for

shock delivery.

defibrillation shock ................ See “SMART biphasic waveform.”

defibrillator pads .................... The self-adhesive electrode pads applied to the adult patient’s bare chest or

pediatric (under 8 years of age or less than 55 lb./25 kg) patient’s bare chest

and back, and used to detect the patient’s heart rhythm and transfer the

D-1

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D-2

defibrillation shock. Use only DP2/DP6, M3870A, M3713A, and M3716A

defibrillator pads with the HeartStart FR2+.

ECG .......................................... Electrocardiogram, a display or printout of the electrical rhythm of the heart

as detected through defibrillator pads.

event ........................................ An action recognized or performed by the HeartStart FR2+ as a step in the

sequence of using the device in an incident. Examples include: applying the

pads and connecting them to the HeartStart FR2+, analyzing heart rhythm,

delivering a shock, etc.

fibrillation ................................ A disturbance of the normal heart rhythm that results in chaotic, disorganized

activity that cannot effectively pump blood. Ventricular fibrillation (fibrillation

in the lower chambers of the heart) is associated with sudden cardiac arrest.

heart rhythm

(ECG) analysis ..................

A system used by the FR2+ to determine if the patient’s heart rhythm is

shockable — ventricular fibrillation (VF) or certain ventricular tachycardias

(VTs). See “SMART analysis.”

HeartStart Event Review ...... A dedicated data management software system (formerly sold as

CodeRunner) for use with the HeartStart FR2+. It is available from Philips

Medical Systems on CD or on the world wide web at

http://www.medical.philips.com/goto/eventreview.

impedance .............................. Electrically, this is the total opposition offered by the body to the flow of the

electrical shock waveform delivered by the HeartStart FR2+. The FR2+

automatically monitors the electrical impedance between the defibrillator

pads placed on the patient’s bare skin, and adjusts the shock waveform

appropriately.

incident .................................... The series of events involved in treating a patient with the HeartStart FR2+.

infrared

communications ...............

A method of sending information using a special part of the light spectrum. It

is used to transmit information to and from the HeartStart FR2+ and another

FR2+ or a computer running HeartStart Event Review software.

manual charge ....................... A feature of the advanced mode used by an authorized ALS-certified

responder that allows the user to arm the HeartStart FR2+ for shock delivery.

manual disarm ....................... A feature of the advanced mode used by an authorized ALS-certified

responder that allows the user to dump the HeartStart FR2+ charge

internally.

monitoring .............................. A mode of background analysis to determine if patient rhythm has changed

to a shockable rhythm.

M3860A/M3861A HEARTSTART FR2+

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D-3

non-shockable

rhythm ................................

A heart rhythm that the HeartStart FR2+ determines is not appropriate for

shock delivery.

NSA .......................................... No Shock Advised decision, made by the HeartStart FR2+ based on

analysis of the patient’s heart rhythm.

pacemaker .............................. External or implanted cardiac pulse generator that stimulates the heart

electronically.

pads ......................................... See “defibrillator pads.”

pause ....................................... A defined period during which the HeartStart FR2+ does not perform rhythm

analysis.

pediatric defibrillation ............ Defibrillation of a child under eight years of age or 55 lbs. (25 Kg). It is

recommended that FR2 infant/child reduced-energy defibrillator pads be

used for pediatric patients.

periodic selftests ................... Daily, weekly, and monthly tests automatically conducted by the FR2+ when

it is in the standby mode. The tests monitor many key functions and

parameters of the FR2+, including battery capacity and the state of its

internal circuitry.

presenting ECG ...................... The heart rhythm seen by the HeartStart FR2+ when it is first connected to

the patient (via the defibrillator pads) and begins rhythm analysis.

prompts ................................... The voice commands and screen text used to guide the responder through

use of the HeartStart FR2+ to treat the patient.

protocol ................................... A sequence of operations performed by the HeartStart FR2+ to direct

patient care in the AED mode.

protocol timeout .................... A programmable interval between shocks, used by the HeartStart FR2+ to

decide if the shocks are part of the same shock series.

read (data) .............................. A feature of the HeartStart FR2+ that allows it to read setup data from a

M3854A data card.

receive (data) ......................... A feature of the HeartStart FR2+ that allows use of its infrared (IR)

communications port to receive revised setup and clock settings directly

from another device.

rechargeable battery .............. The M3848A FR2+ rechargeable battery, used with the M3849A charger

only.

record voice ............................ An optional feature of the HeartStart FR2+ that allows sound recording to a

data card during use of the device in an incident. Activation of this feature

requires revision of the HeartStart FR2+’s default settings.

Glossary of Terms

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D-4

rhythm analysis ...................... See “SMART analysis.”

send (data) ............................. A feature of the HeartStart FR2+ that allows use of its infrared (IR)

communications port to send data directly to another FR2+ or a computer

running HeartStart Event Review Web software.

sensitivity ................................ A measure of the ability of the HeartStart FR2+ to reliably detect and identify

shockable heart rhythms.

setup ........................................ The settings of all programmable operating parameters of the HeartStart

FR2+. The factory default setup can be modified using the M3864A training

& administration pack.

shock series ........................... One or more shocks, each separated by no more than a preset time

(programmed Protocol Timeout). After completion of a shock series, the

HeartStart FR2+ automatically pauses for CPR.

shockable rhythm .................. Ventricular fibrillation and certain ventricular tachycardias associated with

sudden cardiac arrest.

shock waveform ..................... See “SMART biphasic waveform.”

SMART analysis...................... The proprietary algorithm used by the FR2+ to analyze the patient’s heart

rhythm and determine whether a shock is advised.

SMART biphasic

waveform ............................

The patented, low-energy defibrillation shock waveform used by the FR2+. It

is an impedance-compensated biphasic waveform with 150 Joules, nominal,

delivered to a 50 ohm load. When delivered via FR2 infant/child

reduced-energy defibrillator pads, the energy is attenuated to 50 Joules,

nominal.

specificity ................................ A measure of the ability of the HeartStart FR2+ to reliably detect and identify

non-shockable heart rhythms.

standard battery...................... The M3863A battery, 12 VDC, 4.2 Ah, lithium manganese dioxide,

disposable, long-life primary cell.

standby mode ........................ The operating mode of the HeartStart FR2+ when a battery has been

installed, and the unit is turned off and ready for use when needed. Shown by

flashing black hourglass on the Status Indicator.

status indicator ...................... This is a special window in the upper right-hand corner of the front panel of

the HeartStart FR2+ that lets you know the status of the device.

sudden cardiac

arrest ...................................

The sudden cessation of the heart’s pumping rhythm.

M3860A/M3861A HEARTSTART FR2+

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D-5

training &

administration pack ..........

An optional accessory for the FR2+ that enables training and administrative

functions. The integral battery should be charged only using the M3855A

charger.

waveform ................................ See “SMART biphasic waveform.”

write (data) .............................. A feature of the HeartStart FR2+ that allows it to record setup information on

a data card.

Glossary of Terms

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Notes

M3860A/M3861A HEARTSTART FR2+

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Index

asystole detection B-4

accessories

autosend PST

additional, recommended A-2

adult defibrillator pads A-1

available to order A-1

charger for M3848A

rechargeable battery A-1

charger for training &

administration pack A-1

data card A-1

definition 6-1

programmable settings 6-1

battery

description 2-1, D-1

insertion selftest 2-4

replacing during use 4-5, 7-2

data card tray A-1

battery history

fabric carrying case A-1

fast response kit A-1

FR2+ ECG assessment module

A-1

description of data 4-10

reviewing 4-10

battery insertion self-test

infant/child defibrillator pads A-1

rechargeable battery A-1

standard battery A-1

training & administration pack A-1

vinyl carrying case A-1

wall mount bracket A-1

failure 4-14

battery insertion selftest

description 2-4

interactive 4-7

recording test results 4-6

BLS, definition D-1

adult defibrillator pads A-1

advanced mode

definition 6-4, D-1

features 6-9

calibration 4-1

manual analyze 6-10

manual charge 6-11, 6-12, D-2

manual disarm 6-12, D-2

programmable settings 6-4

tiered-response features 6-9

user qualifications 6-9

cautions, warnings, and dangers

5-2

charge

disarming B-3, B-4

time from Shock Advised B-3

chirping 4-11

AED mode, definition D-1

AED, definition D-1

cleaning

FR2+ ECG assessment module

3-5

ALS, definition D-1

agents to use 4-3

guidelines 4-3

applying to child patient 3-2

arrhythmia, definition D-1

I-1

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I-2

clock

receiving settings 2-3, 6-8

damage during CPR 3-6

description D-1

positioning correctly 3-2

specifications B-7

sending settings 6-8

setting independently 2-4

synchronizing 2-3

device history

continued use 4-5, 7-2, D-1

description of data 4-9

reviewing 4-9

contrast, adjusting 4-8

disarming the FR2+

in advanced mode B-4

in AED mode B-3

controls and indicators

specifications B-5

controls and symbols C-1

manual 6-12, B-4

CPR prompt

display screen

definition 6-3

programmable settings 6-3

adjusting contrast 4-8

specifications B-5

CPR timer

DP2/DP6 adult defibrillator pads

definition 6-2, D-1

programmable settings 6-2

A-1

ECG analysis

dangers, warnings, and cautions

see SMART analysis

5-2

ECG analysis system

data card

description D-2

reading setup 6-8

recommended use 4-6

recording time available 4-6

removing 7-3

ECG assessment module 3-5

ECG display

definition 6-1

replacing 7-3

programmable settings 6-1

specifications B-5

defibrillation charge D-1

defibrillation therapy 1-2

defibrillation, definition D-1

ECG, definition D-2

event, definition D-2

defibrillator

specifications B-2

fibrillation, definition D-2

defibrillator pads

flashing black hourglass

applying to adult patient 3-2

applying to patient 3-2

checking before use 3-2

connecting to the FR2+ 3-2

see Status Indicator

flashing red X

see Status Indicator

M3860A/M3861A HEARTSTART FR2+

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I-3

indications and contraindications

glossary

1-2, 5-1

of terms D-1

of symbols and controls C-1

infrared communications

description D-2

receiving setup 6-6

installing the battery 2-1

heart rhythms

shockable B-4

HeartStart M3870A FR2

infant/child reduced-energy

defibrillator pads A-1

LCD display

see display screen

hourglass Status Indicator C-2

how to install the battery 2-1

M3848A rechargeable battery A-1,

B-7

how to remove the data card 7-3

how to review battery history 4-10

how to review device history 4-9

M3849A charger for M3848A

rechargeable battery A-1, B-7

M3854A data card A-1, B-8

how to review the presenting ECG

M3855A charger for M3864A

training & administration pack

A-1, B-8

7-5

how to run the battery insertion

selftest 2-4

M3857A wall mount bracket A-1

how to use the advanced mode 6-9

M3860A and M3861A FR2+,

description 1-1

How to use the M3873A/M3874A

ECG assessment module 3-5

M3863A battery A-1, B-6

M3864A training & administration

pack A-1, B-8

impedance

M3868A carrying case A-1

automatic adjustment of shock

waveform B-2

troubleshooting 4-13

M3870A FR2 infant/child

reduced-energy defibrillator pads

A-1, B-7

impedance, definition D-2

M3873A/M3874A ECG

assessment module 3-5, A-1,

B-8

incident data

definition of data on data card 7-4

definition of internal memory data

7-3

main menu 2-2

reviewing from data card 7-4

reviewing from internal memory

7-3

maintenance

after using the FR2+ 4-2

cleaning 4-3

incident, definition D-2

daily selftests 4-1

Index

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I-4

monthly selftests 4-1

pediatric defibrillation

operator’s checklist 4-3

recommended schedule 4-1

choosing defibrillator pads 3-2

periodic selftests

definition D-3

manual mode

see advanced mode

description 4-9

frequency 4-1

Status Indicator alerts 4-9

monitoring, description D-2

presenting ECG

definition D-3

non-shockable rhythms D-3

description 7-5

NSA action

prompt interval

definition 6-3

programmable settings 6-3

monitor settings 6-5

prompt intervals

NSA, definition D-3

advanced use settings 6-5

definition 6-5

prompts, definition D-3

On/Off button, description of uses

C-1

protocol timeout

definition 6-2, D-3

programmable settings 6-2

operating temperature B-1

Option buttons

protocol, definition D-3

description of uses C-1

to adjust display screen contrast

4-8

record voice

definition 6-1, D-3

programmable settings 6-1

pacemaker

definition D-3

detection B-4

recording incident data

in internal memory 7-1

pads placement, adult and pediatric

replacing battery during use 7-2

3-2

replacing data card 7-3

patient impedance B-2

responder

pause for CPR, description 3-4

qualifications and training 1-2

pause key

resume key

definition 6-4

definition 6-5

programmable settings 6-4

programmable settings 6-5

pause, definition D-3

reviewing incident data

from data card 7-4

pause, time indication 3-4

from internal memory 7-3

M3860A/M3861A HEARTSTART FR2+

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I-5

rhythm analysis

speaker volume

see SMART analysis

definition 6-1

programmable settings 6-1

specifications

safety considerations 5-1

battery B-6

controls and indicators B-5

defibrillator B-2

defibrillator pads B-7

display screen B-5

ECG analysis performance B-5

ECG analysis system B-4

environmental B-1

selftests

battery insertion 2-4

daily 4-1

monthly 4-1

periodic 2-5, 4-1

sensitivity, definition D-4

physical B-1

setup

definition D-4

reading setup 6-8

receiving setup 6-6

specificity, definition D-4

standby mode, definition D-4

standby temperature B-1

shock

see SMART biphasic waveform

Status Indicator

description D-4

Shock button, description of use

flashing black hourglass C-2

flashing red X 4-12, C-2

in standby mode 2-5

solid red X C-2

C-1

shock series

definition 6-2, D-4

programmable settings 6-2

sterilization 4-3

shock waveform

storage conditions B-1

see SMART biphasic waveform

sudden cardiac arrest, definition

shockable rhythms D-4

D-4

SMART analysis

definition D-4

symbols

on accessory packaging C-3

on battery C-4

on FR2+ control panel and back

during CPR 3-6

specifications B-4

SMART biphasic waveform

definition D-4

label C-1

on FR2+ display screen C-2

on FR2+ status indicator C-2

on Instructions for Use C-1

energy delivered B-3

shock delivery vector B-4

shock waveform B-2

specification B-2

symbols and controls C-1

solid red X

see Status Indicator

Index

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I-6

temperature

operating B-1

standby B-1

warnings, cautions, and dangers

5-2

waveform

tiered-response features 6-9

see SMART biphasic waveform

training & administration pack

charger A-1

description D-5

X Status Indicator

flashing or solid 4-11

solid 4-11

troubleshooting 4-11

user, qualifications and training 1-2

M3860A/M3861A HEARTSTART FR2+

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Intentionally left blank.

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P O W E R T O S A V E

L I F E

Philips Medical Systems

Philips Medical Systems is part

of Royal Philips Electronics

USA

Philips Medical Systems

2301 Fifth Avenue, Suite 200

Seattle, WA 98121, USA

(800) 263-3342

Canada

Philips Medical Systems

281 Hillmount Road

Markham, Ontario

L6C 2S3, Canada

(800) 291-6743

Europa, Midt-Østen og Afrika

Philips Medizinsysteme Boeblingen GmbH

Hjerte- og overvåkingssystemer

Hewlett-Packard Strasse 2

71034 Boeblingen, Tyskland

(+49) 7031-463-1552

Latin-Amerika

Philips Medical Systems

1550 Sawgrass Corporate Parkway, Suite 300

Sunrise, FL 33323, USA

(954) 835-2660

Stillehavslandene i Asia

Philips Electronics Hong Kong Ltd.

30th Floor, Hopewell Centre

17, Kennedy Road, Wanchai,

Hong Kong

(852) 2821 5888

M3860-91900

011120-0010

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