The HeartStart FR2+ Defibrillator

Clockwise from top right.

A Battery. Standard long-life or rechargeable battery used to power the FR2+. (Check local regulations for disposal and recycling requirements.)

B On/Off button. Turns on the FR2+ and starts voice and screen prompts. Second press turns off the FR2+.

C Status Indicator. Shows you the readiness status of the FR2+.

D Display screen. Displays text prompts and incident data. The FR2+ M3860A screen also displays the patient???s ECG.

E Option buttons. Adjust the contrast of the screen display and control special functions.

F Beeper port. Broadcasts alert beeps when required. It is located under the right edge of the FR2+.

G Infrared (IR) communications

port. A special lens, or ???eye,??? used to transfer data directly to or from another device.

H Data card port. Receptacle for data card tray.

I Data card (optional). Used to store and review information about an incident, including ECG and optional voice recording.

J Data card tray. Special sleeve that holds the data card and fits into the data card port to help seal the FR2+ against fluids. The tray should be kept installed in the FR2+ even if no data card is used.

K Microphone. Used optionally to record surrounding audio during an incident. It is located under the right edge of the FR2+.

L Shock button. Controls shock delivery. The button flashes when the HeartStart FR2+ is ready to deliver a shock.

M Speaker. Amplifies voice prompts during use of the FR2+.

N Pads placement diagram.

Illustrates correct placement of pads.

Diagrams are also shown on the defibrillator pads.

O Defibrillator pads connector

socket. Receptacle for connector of the defibrillator pads cable. An adjacent LED light flashes to show socket location and is covered when connector is inserted.

P Adult defibrillator pads. Self- adhesive pads with attached cable and connector.

P hilip s Med ical Systems

Instructions for Use

Equipment specifications are subject to alteration without notice. All changes will be in compliance with regulations governing manufacture of medical equipment.

Printed in the U.S.A.

Publication date: August 2003

Publication number: M3860-91900

Part number: 011120-0010

?? 2003 Philips Electronics North America Corp.

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.

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.

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.

Authorized EU Representative

Philips Medizinsysteme Boeblingen GmbH

Hewlett-Packard Strasse 2

71034 Boeblingen, Germany

(+49) 7031-14-5151

CAUTION

FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE

BY OR ON THE ORDER OF A PHYSICIAN.

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.

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.

Device Manufacturer

The HeartStart FR2+ Defibrillator is manufactured by Philips Medical Systems, Seattle, Washington, USA.

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Contents

4 Maintaining, Testing, and Troubleshooting

Your HeartStart FR2+

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1 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.

N O T E : 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:

N O T E : 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.)

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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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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.

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2Preparing Your HeartStart FR2+ for Use

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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.

C A U T I O N : Follow all instructions supplied with the HeartStart M3863A standard battery. Install the battery before the install-by date shown on the battery.

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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.

N O T E : 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.

N O T E : 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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N O T E : 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 2 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+.

N O T E : 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.

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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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.

N O T E : 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.

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GOOD BATTERY

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.

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.

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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.)

N O T E : 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.)

???

???

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.

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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. I M P O R T A N T : 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.

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.

N O T E : 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.

N O T E : 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+.)

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Step 3: Shock Delivery

Press the Shock button to deliver the shock.

I M P O R T A N T : 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.

N O T E : 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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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 3 (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.

N O T E : 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.

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cleaning the FR2+ Defibrillator. (See Chapter 4, ???Maintaining, Testing, and Troubleshooting Your HeartStart FR2+.???)

W AR NI NG : 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.

W AR NI NG : 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.

W AR NI NG : 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.

W AR NI NG : CPR rates significantly above 100 compressions per minute can cause incorrect or delayed analysis by the FR2+.

W AR NI NG : 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.

C A U T I O N : 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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4Maintaining, 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 more4 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.

C A U T I O N : 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.

C A U T I O N : 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.

???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. N O T E : 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.

???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

C A U T I O N : 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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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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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.

N O T E : 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

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.

N O T E : 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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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.)

N O T E : 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.

N O T E : It is recommended that the M3848A FR2+ rechargeable battery not be used as a spare or backup battery.

N O T E : 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 4 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.

N O T E : 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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Troubleshooting Guide

Status indicator summary

Flashing black hourglass The FR2+ passed the battery insertion self-test or the last periodic self-test and is therefore ready for use.

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.

N O T E : 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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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

STATUS INDICATOR: FLASHING RED X

STATUS INDICATOR: FLASHING BLACK HOURGLASS

???Replace the battery with a new M3863A FR2 standard or a charged M3848A FR2+ rechargeable battery as soon as possible.

Screen and voice prompts:

APPLY PADS AND

PRESS PADS FIRMLY

or

PLUG IN CONNECTOR

Or voice prompts:

INSERT CONNECTOR FIRMLY

or

PRESS PADS FIRMLY TO

PATIENT'S BARE CHEST

or

POOR PADS CONTACT

Voice and screen prompts:

REPLACE PADS

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M3860A/M3861A HEARTSTART FR2+

recommended action

???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.

???Make sure the defibrillator 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.

???When next prompted, press the Shock button to deliver shock.

symptom

General troubleshooting

Status Indicator:

FLASHING RED X

Audio signal:

CHIRPING

???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.

???The FR2+ has been unable to perform its daily self-tests.

???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+

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

Audio signal:

CHIRPING

Screen prompt (displayed for 10 seconds at the end of a BIT, before FR2+ turns off):

NOT READY FOR USE

or

SELFTEST FAILED

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 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+.

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.

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symptom

Status Indicator:

SOLID RED X

Audio signal:

NONE

Status Indicator:

SOLID RED X

Audio signal:

CHIRPING

Status Indicator:

NONE

possible cause

???The battery is missing or completely depleted.

???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.

???A self-test detected a failure.

???The training & administration pack is being used in the

ADMINISTRATION function 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).

The FR2+ has been physically damaged.

recommended action

???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 & administration pack and install a battery.

???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+

???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.

???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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5 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.

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.

???D AN G E R??? immediate hazards that will result in personal injury or death.

???W AR NI NG ??? conditions, hazards, or unsafe practices that can result in serious personal injury or death.

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??? C A U T I O N ??? 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.

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Medical Director. Modifications to device operation resulting from changes to the default settings should be specifically covered in user training.

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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.

??? 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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description

Enables or disables advanced mode entry for ALS or tiered-response systems.

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.

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 ??? 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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Using Setup Features

N O T E : 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

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

N O T E : 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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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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6-7

???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.)

C A U T I O N : 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 6 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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???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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6-9

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 &6 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.)

C A U T I O N : 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.

C A U T I O N : 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.

N O T E : 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)

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7 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.

I M P O R T A N T N O T E : To record incident data on a data card, the data card must be installed before you turn on the FR2+.

*HeartStart Event Review software was previously sold as CodeRunner software.

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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.

N O T E : 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.

I M P O R T A N T N O T E : 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.

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To replace a data card:

I M P O R T A N T : 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:

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

??? how many shocks were delivered during the incident.

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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.

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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.

N O T E : 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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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+.

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7

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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, A 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.

B-2

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.

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*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, GA: Centers for Disease Control and Prevention ?? 2000.

??? the defibrillator pads are removed from the patient or the pads connector is disconnected from the FR2+.

B-4

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Pads, Cable, and Connector Disposable and self-adhesive. DP2/DP6 adult defibrillator pads have a nominal active surface area of 100 cm2 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 cm2 each and are provided in a sealed package with an integrated 122 cm (48 inch), typical, cable and connector incorporating attenuating electronics.

B-8

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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.

P hili

Defibrillation protection. Defibrillation protected, type BF patient connection.

symbol

HR XXX

XX

XX:XX

TEMPERATURE

SETUP

REV: XXX X.X

XXXX

description

Heart rate.

Number of shocks delivered.

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.

Setup. Setup has been lost from memory; factory default setup is being used. Contact Medical Director for revised setup.

Software. The version of software used in your HeartStart FR2+.

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C-3

Status indicator

symboldescription

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

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.

C-4

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)

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C-5

symboldescription

Box contents = 2 pouches. (DP2)

2

C

Box contents = 6 pouches. (DP6)

6

This side up.

Fragile.

Protect from moisture.

Printed on recycled paper.

M3863A standard battery and

M3848A FR2+ rechargeable battery

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.

C-6

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

Refer to operating instructions.

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C-7

High voltage.

C

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

C-8

M3873A/M3874A FR2+ ECG assessment module

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

Refer to operating instructions.

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C-9

Do not crush.

C

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.

C-10

Printed on recycled paper.

M3855A charger

for the M3864A training & administration pack)

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.

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D-4

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Index

A

accessories

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

data card tray A-1 fabric carrying case A-1 fast response kit A-1

FR2+ ECG assessment module

A-1

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

adult defibrillator pads A-1

advanced mode definition 6-4, D-1 features 6-9

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

AED mode, definition D-1

AED, definition D-1

ALS, definition D-1

applying to child patient 3-2

arrhythmia, definition D-1

asystole detection B-4

autosend PST definition 6-1

programmable settings 6-1

B

battery

description 2-1, D-1 insertion selftest 2-4 replacing during use 4-5, 7-2

battery history

description of data 4-10 reviewing 4-10

battery insertion self-test failure 4-14

battery insertion selftest description 2-4 interactive 4-7

recording test results 4-6

BLS, definition D-1

C

calibration 4-1

cautions, warnings, and dangers

5-2

charge

disarming B-3, B-4

time from Shock Advised B-3

chirping 4-11

cleaning

FR2+ ECG assessment module

3-5

agents to use 4-3 guidelines 4-3

INDEX

clock

receiving settings 2-3, 6-8 sending settings 6-8 setting independently 2-4 synchronizing 2-3

continued use 4-5, 7-2, D-1

contrast, adjusting 4-8

controls and indicators specifications B-5

controls and symbols C-1

CPR prompt definition 6-3

programmable settings 6-3

CPR timer

definition 6-2, D-1 programmable settings 6-2

D

dangers, warnings, and cautions

5-2

data card

reading setup 6-8 recommended use 4-6 recording time available 4-6 removing 7-3

replacing 7-3

defibrillation charge D-1

defibrillation therapy 1-2

defibrillation, definition D-1

defibrillator specifications B-2

defibrillator pads

applying to adult patient 3-2 applying to patient 3-2 checking before use 3-2 connecting to the FR2+ 3-2

damage during CPR 3-6 description D-1 positioning correctly 3-2 specifications B-7

device history description of data 4-9 reviewing 4-9

disarming the FR2+

in advanced mode B-4 in AED mode B-3 manual 6-12, B-4

display screen adjusting contrast 4-8 specifications B-5

DP2/DP6 adult defibrillator pads

A-1

E

ECG analysis

see SMART analysis

ECG analysis system description D-2

ECG assessment module 3-5

ECG display definition 6-1

programmable settings 6-1 specifications B-5

ECG, definition D-2

event, definition D-2

F

fibrillation, definition D-2

flashing black hourglass see Status Indicator

flashing red X

see Status Indicator

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G

glossary

of terms D-1

of symbols and controls C-1

indications and contraindications

1-2, 5-1

infrared communications description D-2 receiving setup 6-6

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H

heart rhythms shockable B-4

HeartStart M3870A FR2 infant/child reduced-energy defibrillator pads A-1

hourglass Status Indicator C-2

how to install the battery 2-1

how to remove the data card 7-3

how to review battery history 4-10

how to review device history 4-9

how to review the presenting ECG

7-5

how to run the battery insertion selftest 2-4

how to use the advanced mode 6-9

How to use the M3873A/M3874A ECG assessment module 3-5

I

impedance

automatic adjustment of shock waveform B-2

troubleshooting 4-13

impedance, definition D-2

incident data

definition of data on data card 7-4 definition of internal memory data

7-3

reviewing from data card 7-4 reviewing from internal memory

7-3

incident, definition D-2

installing the battery 2-1

L

LCD display

see display screen

M

M3848A rechargeable battery A-1, B-7

M3849A charger for M3848A rechargeable battery A-1, B-7

M3854A data card A-1, B-8

M3855A charger for M3864A training & administration pack

A-1, B-8

M3857A wall mount bracket A-1

M3860A and M3861A FR2+,

description 1-1

M3863A battery A-1, B-6

M3864A training & administration pack A-1, B-8

M3868A carrying case A-1

M3870A FR2 infant/child reduced-energy defibrillator pads

A-1, B-7

M3873A/M3874A ECG assessment module 3-5, A-1, B-8

main menu 2-2

maintenance

after using the FR2+ 4-2 cleaning 4-3

daily selftests 4-1

INDEX

monthly selftests 4-1 operator???s checklist 4-3 recommended schedule 4-1

manual mode

see advanced mode

monitoring, description D-2

N

non-shockable rhythms D-3

NSA action definition 6-3

programmable settings 6-3

NSA, definition D-3

O

On/Off button, description of uses

C-1

operating temperature B-1

Option buttons description of uses C-1

to adjust display screen contrast

4-8

P

pacemaker definition D-3 detection B-4

pads placement, adult and pediatric

3-2

patient impedance B-2

pause for CPR, description 3-4

pause key definition 6-4

programmable settings 6-4

pause, definition D-3

pause, time indication 3-4

pediatric defibrillation

choosing defibrillator pads 3-2

periodic selftests definition D-3 description 4-9 frequency 4-1

Status Indicator alerts 4-9

presenting ECG definition D-3 description 7-5

prompt interval monitor settings 6-5

prompt intervals

advanced use settings 6-5 definition 6-5

prompts, definition D-3

protocol timeout definition 6-2, D-3

programmable settings 6-2

protocol, definition D-3

R

record voice definition 6-1, D-3

programmable settings 6-1

recording incident data in internal memory 7-1

replacing battery during use 7-2

replacing data card 7-3

responder

qualifications and training 1-2

resume key definition 6-5

programmable settings 6-5

reviewing incident data from data card 7-4

from internal memory 7-3

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rhythm analysis

see SMART analysis

S

safety considerations 5-1

selftests

battery insertion 2-4 daily 4-1

monthly 4-1 periodic 2-5, 4-1

sensitivity, definition D-4

setup

definition D-4 reading setup 6-8 receiving setup 6-6

shock

see SMART biphasic waveform

Shock button, description of use

C-1

shock series definition 6-2, D-4

programmable settings 6-2

shock waveform

see SMART biphasic waveform

shockable rhythms D-4

SMART analysis definition D-4 during CPR 3-6 specifications B-4

SMART biphasic waveform definition D-4

energy delivered B-3 shock delivery vector B-4 shock waveform B-2 specification B-2

solid red X

see Status Indicator

speaker volume definition 6-1

programmable settings 6-1

specifications 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

physical B-1

specificity, definition D-4

standby mode, definition D-4

standby temperature B-1

Status Indicator description D-4

flashing black hourglass C-2 flashing red X 4-12, C-2

in standby mode 2-5 solid red X C-2

sterilization 4-3

storage conditions B-1

sudden cardiac arrest, definition

D-4

symbols

on accessory packaging C-3 on battery C-4

on FR2+ control panel and back label C-1

on FR2+ display screen C-2 on FR2+ status indicator C-2 on Instructions for Use C-1

symbols and controls C-1

INDEX

T

temperature operating B-1 standby B-1

tiered-response features 6-9

training & administration pack charger A-1

description D-5

troubleshooting 4-11

W

warnings, cautions, and dangers

5-2

waveform

see SMART biphasic waveform

X

X Status Indicator flashing or solid 4-11 solid 4-11