HeartStart FR3 Defibrillator Instructions for Administrators Edition 1 March 2011

J

I

A

B

K

C

L

D E

F

P H IL I P S M ED I C A L S YS TE M S

G

M

N

H

O P

Diagram of the HeartStart FR3 Defibrillator A Defibrillator pads connector socket. Receptacle for the defibrillator pads cable connector. A light on the socket flashes when the FR3 is turned on to show socket location. B

Green On/Off button. Turns on the FR3 and starts voice and text prompts. A second press brings up the status screen, and then turns off the FR3. C Green Ready light. Shows the readiness status of the FR3. D Microphone. Used optionally to record audio during an incident. E Infant/Child Key port. Accommodates the optional FR3 Infant/Child Key accessory to enable pediatric treatment protocols for patients under 55 lbs (25 kg) or 8 years old. F Screen. Displays text prompts, graphics, and incident data. The FR3

ECG model also displays the patient’s ECG if enabled. G Option buttons (three). When pressed, activates the function identified on the screen. H Orange Shock button. Controls shock delivery. The button flashes when the FR3 is ready to deliver a shock. I SMART Pads III. Self-adhesive pads supplied with attached cable and connector. If using the optional FR3 system case and/or the Pads Sentry, store pads in Pads Sentry and pre-connect pads to FR3 for automatic self-test. J Battery. Long-life battery used to power the FR3. K Battery compartment. Provides electrical connection for the installed battery and contains the data card slot and Bluetooth® wireless technology transceiver module compartment.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

L Data card slot. Receptacle for the optional data card accessory. Located beneath the battery in the battery compartment. M Bluetooth wireless technology transceiver module compartment. Accommodates the optional transceiver module accessory. Located behind a removable door in battery compartment. N Speaker. Broadcasts FR3 voice prompts and alert tones when appropriate. O Beeper. Broadcasts FR3 alert chirps when appropriate. P Accessory port. Connection port for future use.

HeartStart FR3 ECG 861389 and Text 861388 Automated External Defibrillator

I N S T R U C T I O N S F O R A D M I N I S T R ATO R S Edition 1

P H I L IP S M E D I C A L S YS T E M S

IMPORTANT NOTE:

It is important to understand that survival rates for sudden cardiac arrest are directly related to how soon victims receive treatment. For every minute of delay, the chance of survival declines by 7% to 10%. Treatment cannot assure survival. In some patients, the underlying problem causing the cardiac arrest is simply not survivable despite any available care.

About this Edition

Device Tracking

The information in this guide applies to the HeartStart FR3 ECG model 861389 and FR3 Text model 861388 defibrillators. This information is subject to change. Please contact Philips at www.philips.com/productdocs or your local Philips representative for information on revisions.

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.

Edition History Edition 1 Publication date: March 2011 Publication number: 453564140691

Copyright © 2011 Koninklijke Philips Electronics N.V.

P H I L IP S M E D I C A L S YS T E M S

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 and/or to discontinue any product at any time without notice or obligation and will not be liable for any consequence resulting from use of this publication.

Authorized EU Representative Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Strasse 2 71034 Boeblingen, Germany (+49) 7031 463-2254

CAUTION Federal law (USA) restricts this device to sale by or on the order of a physician.

Device Manufacturer Philips Medical Systems, Seattle, WA 98121-1825, USA

Patents This product is manufactured and sold under one or more of the following United States patents: US5591213, US5601612, US5607454, US5611815, US5617853, US5632280, US5650750, US5735879, US5749905, US5773961, US5776166, US5800460, US5803927, US5836993, US5868792, US5879374, US5889388, US5891046, US5891049, US5899926, US5902249, US5904707, US5951598, US5967817, US6016059, US6075369, US6185458, US6230054, US6234816, US6272385, US6287328, US6299574, US6317635, US6319031, US6350160, US6356785, US6405081, US6417649, US6441582, US6553257, US6556864, US6611708, US6871093, US7079894, and other patents pending.

Trademarks The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Philips Medical Systems is under license. Koninkijke Philips Electronics, N.V., is an Associate Member of the Bluetooth SIG.

For Technical Support If you need technical support, please contact your local Philips representative or go to www.philips.com/ AEDsupport.

TABLE OF CONTENTS 1

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2

INTRODUCTION Device Description ...

1-1

Indications for Use ...

1-1

Principles of Operation ...

1-2

Training and Practice ...

1-2

State and Local Requirements ...

1-3

For More Information ...

1-3

SETUP Package Contents ...

2-1

Assembling the Optional FR3 Rigid System Case ...

2-2

Installing the Optional FR3 Data Card ...

2-2

Installing the Optional Bluetooth Wireless Technology Transceiver Module ...

2-3

Installing the Battery ...

2-4

Setting the Date and Time ...

2-5

Connecting the Pads ...

2-7

Storing the Optional Infant/Child Key ...

2-9

Storing the Optional Fast Response Kit ... 2-10 Placing and Securing the FR3 ... 2-11 Recommended Accessories ... 2-13

3

APPLICATION Basic Directions ...

3-1

Detailed Directions ...

3-1

Treating Infants and Children ...

3-4

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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4

MAINTENANCE, TESTING, AND TROUBLESHOOTING Maintenance ... Routine Maintenance ... After Each Use ... Cleaning ... Operator’s Checklist ...

4-1 4-1 4-3 4-4 4-4

Testing ... 4-6 Periodic Self-Tests ... 4-6 User-Initiated Test ... 4-7 Device History ... 4-9 Battery History ... 4-11 Software Information ... 4-12

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Troubleshooting Guide ... 4-13 General Troubleshooting ... 4-13 Troubleshooting during Patient Use ... 4-14 Informational and Error Messages ... 4-18

5

6

SAFETY General Dangers, Warnings, and Cautions ...

5-1

Defibrillation Warnings and Cautions ...

5-3

Monitoring Cautions ...

5-4

Maintenance Cautions ...

5-5

CONFIGURATION Non-Protocol Parameters ... Language Selection Parameters ... Device Operation Parameters ... Self-Test Options Parameters ...

6-2 6-2 6-3 6-3

Patient Care Parameters ... Types of CPR Protocols ... CPR Protocol Parameters ... Defibrillation Parameters ... Advanced Mode Parameters ...

6-4 6-4 6-5 6-7 6-8

Viewing Setup ...

6-9

Modifying Setup ... 6-10 Using HeartStart Configure and an FR3 Data Card ... 6-11 Using HeartStart Configure and Wireless Transmission ... 6-13 Saving Setup to an FR3 Data Card ... 6-15

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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Modifying FR3 Language ... 6-16 Changing the Primary Language Only ... 6-16 Enabling the Bilingual Option and/or Changing Other Configuration Settings ... 6-18 Device Behavior in Bilingual Operation ... 6-20

7

DATA MANAGEMENT Recorded Incident Data ... Last-Use Data Recorded in Internal Memory ... Data Recorded on an FR3 Data Card ...

7-1 7-1 7-2

Reviewing Incident Data ... Reviewing Last-Use Data in Internal Memory ... Reviewing Data from an FR3 Data Card ...

7-2 7-2 7-4

APPENDICES P H I L IP S M E D I C A L S YS T E M S

A Accessories B Glossary C Symbols and Controls D SMART CPR E

NSA Action

F

Advanced Mode

G Specifications H Additional Technical Data Required for European Conformity

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1

INTRODUCTION DEVICE DESCRIPTION The HeartStart FR3 Defibrillator (FR3) is a compact, lightweight, batterypowered automated external defibrillator designed for use by trained responders to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs).

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The FR3 has a Ready light that flashes to indicate that the FR3 has passed its last self-test and is therefore ready to use. The front panel of the FR3 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, graphics, and incident information. Voice prompts are provided through a speaker located at the base of the FR3. See the diagram on the inside front cover of this manual for details. The FR3 is available in the FR3 ECG model 861389 and the FR3 Text model 861388. They share a set of basic features, detailed in Chapter 6, “Configuration.” The principle differences between the two are identified below: FR3 ECG Model 861389

FR3 Text Model 861388

Text prompt and 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 FR3 comes with a factory default setup that can be modified under medical direction. For a description of setup defaults and options, see Chapter 6, “Configuration.”

INDICATIONS FOR USE The FR3 is intended for use by trained responders to treat ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardias (VTs). The FR3 is used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: • Unresponsiveness • Absence of normal breathing If in doubt, apply the pads.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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The FR3 is intended for adults and children over 55 lbs (25 kg) or 8 years old. The FR3 is also intended for children under 55 lbs (25 kg) or 8 years old when used with the optional FR3 Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child’s age or weight, do not delay treatment. Apply the pads as illustrated for a child and use the defibrillator. For pads placement and details, see Chapter 3, “Application.” WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings for the CPR First feature has not been established in patients under 55 lbs (25 kg) or 8 years old. For more information, see Appendix D, “SMART CPR.” The FR3 is intended for use by responders who have been trained in its operation and in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program.

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For a list of accessories and training products for the FR3 available from Philips, see Appendix A, “Accessories.”

PRINCIPLES OF OPERATION The FR3 is designed to provide external defibrillation therapy to someone experiencing sudden cardiac arrest caused by ventricular fibrillation (VF), the most common cause of SCA, and certain ventricular tachycardias (VTs). The only effective treatment for these non-perfusing arrhythmias is defibrillation. The FR3 treats them by sending a shock across the heart, so it can start beating regularly again. The FR3 is designed to be easy to use. In its default AED mode, when connected to defibrillator pads that are properly applied to the patient’s bare chest, the FR3 prompts you to take specific actions; automatically analyzes the patient's heart rhythm and advises you whether or not the rhythm is shockable; and, if advised by its rhythm analysis algorithm, arms the Shock button and instructs you to press it to deliver a biphasic electric pulse designed to defibrillate the heart. For detailed instructions for use, see Chapter 3, “Application.”

TRAINING AND PRACTICE The FR3 is intended for use with the oversight of a physician as part of a welldesigned emergency response plan. Responders should be trained in operation of the FR3 and in Basic Life Support (BLS), in Advanced Life Support (ALS), or another physician-authorized emergency medical response program. Philips recommends that responders be trained on the device they will be using.

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Several national and local organizations offer combined CPR/defibrillator training. Contact your Philips representative, or visit us online at www.philips.com/ AEDServices for information, including certified training and web-based refresher training, currently offered in the U.S. only, through Philips HeartStart AED Services. NOTE: Training accessories are available from Philips for practicing how to use the FR3. For a list of available accessories, see Appendix A, “Accessories.”

STATE AND LOCAL REQUIREMENTS Check with your local health department officials to see if there are any state or local requirements about owning and using a defibrillator.

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FOR MORE INFORMATION If, after reading this manual, you have additional questions about the FR3, contact your local Philips representative. We will be happy to answer any questions you may have. Technical information about all Philips HeartStart automated external defibrillators, including clinical summaries of several key studies using Philips automated external defibrillators,* is also available online at www.philips.com/ productdocs, in the Technical Reference Manuals for HeartStart Automated External Defibrillators.

* Clinical summaries also include defibrillators sold as ForeRunner and FR2.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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2

SETUP PACKAGE CONTENTS Check the contents of the HeartStart FR3 Defibrillator (FR3) box to be sure it contains the following items: 1 HeartStart FR3 Defibrillator 1 FR3 battery 1 set of SMART Pads III 1 Guide to Setup, Operation, and Maintenance

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1 Administrator’s Reference CD-ROM The Guide to Set-Up, Operation, Maintenance, and Accessories provides directions for use of the FR3 with the factory-set default configuration and the FR3 language card. The FR3 language card is supplied with certain versions of the FR3 and is also available separately. Under supervision of the Medical Director, you can use the language card to change the primary language of the FR3. See “Changing the Primary Language Only” on page 6-16 for instructions. Under supervision of the Medical Director, you can use the HeartStart Configure software, available separately from Philips, to modify the default configuration for FR3 device operation, self-test options, patient care, defibrillation, and advanced mode parameters. HeartStart Configure is also required to enable the FR3 bilingual option and select a secondary language. See Chapter 6, “Configuration.” If you purchased additional accessories, the shipping box will include the items and their indications for use and instructions for use, as appropriate. NOTE: This chapter provides directions for setting up the FR3. In addition to the battery and pads, the instructions cover the following optional accessories: • FR3 rigid system case, including Pads Sentry • FR3 data card • Bluetooth wireless technology transceiver module • FR3 Infant/Child Key • FR3 Fast Response Kit • Secure pull case seal For information on ordering accessories, see Appendix A, “Accessories.”

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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ASSEMBLING THE OPTIONAL FR3 RIGID SYSTEM CASE The FR3 rigid system case* requires some minor assembly prior to use. To assemble the case, following these steps: 1. Remove the system case and its components from packaging and open the system case. 2. If you will be pre-connecting the HeartStart SMART Pads III to the FR3, install the Pads Sentry in the case. The Pads Sentry is required for testing the pre-connected pads during the FR3 periodic self-tests. •

Fit the tab at the closed end of the Pads Sentry into the corresponding socket inside the front of the compartment (1).

•

Then press the open end of the Pads Sentry down into the back of the compartment until it clicks into place (2).

P H I L IP S M E D I C A L S YS T E M S

Pads Sentry

2 1

INSTALLING THE OPTIONAL FR3 DATA CARD You can use the optional FR3 data card to record detailed information about the operation and use of the FR3. For details about how to manage incident data stored on the data card, see Chapter 7, “Data Management.”

* Directions and illustrations in this chapter address use of the FR3 rigid system case. The FR3 soft system case and small soft case, described in Appendix A, “Accessories.” are shipped with directions for setup and use.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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To install the data card in the FR3, follow these steps: 1. Locate the data card slot in the bottom of the battery compartment on the back of the FR3. A label in the battery compartment shows the location of the data card slot. 2. Slide the data card into the data card slot in the direction indicated on the label. A retention clip helps hold the card in the slot. The tail on the data card serves as a visual reminder that a card is installed and aids in card removal.

P H I L IP S M E D I C A L S YS T E M S

NOTE: To remove the data card, grasp the card by its tail, press the retention clip away from the card, and pull the card out. See illustration on page 6-18.

INSTALLING THE OPTIONAL BLUETOOTH WIRELESS TECHNOLOGY TRANSCEIVER MODULE If you have the optional Bluetooth wireless technology transceiver module, follow these steps to install it in the FR3: 1. Locate the transceiver module compartment in the side of the battery compartment on the back of the FR3. 2. Insert the blade of a flat-head screwdriver or a similar tool (not included) into the slot on the surface of the FR3. Pry open the top of the module compartment cover, then lift out the cover and set it aside.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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P H I L IP S M E D I C A L S YS T E M S

3. Place the transceiver module inside the compartment and fit it all the way down into the compartment.

4. Place the bottom edge of the module compartment cover in the track at the bottom of the compartment. Be sure the small tab on the bottom of the cover fits into the track. Then snap the top in place, being careful not to pinch your finger. IMPORTANT NOTE: Be sure to reinstall the module compartment cover properly. The cover is part of the water protection seal of the FR3 and must be flush with the compartment wall.

INSTALLING THE BATTERY The FR3 is shipped with an FR3 clinical use standard battery. The battery pack is gray with a latch at each end, designed to hold the battery in place when it is correctly installed in the FR3. To install the battery, follow these steps: 1. Check the battery label to be sure the battery is within its install-by date in order to get the full specified battery life. 2. Remove the battery from its packaging. Keep the battery insert for reference.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

2-4

3. Insert the battery into the battery compartment on the back of the FR3. Be sure that both the battery’s latches click into place. The first time you set up the FR3, the FR3 automatically runs a detailed user-initiated test as soon as the battery is in place.* Press each button when directed, or the test will fail.

P H I L IP S M E D I C A L S YS T E M S

NOTE: Philips recommends that you have a spare battery. If you are using an FR3 system case, store the spare battery in the space provided in the bottom of the case, as illustrated below. Otherwise, keep the spare battery in its packaging.

Spare battery

SETTING THE DATE AND TIME The date format of the FR3 is the year in four digits, followed by the name of the month, then the day in two digits. For example: 2010 February 17. The time format uses a 24-hour clock and shows two digits each for the hour, minute, and second. For example: 18:05:54.

* For details, see “User-Initiated Test” on page 4-7

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The first time you set up the FR3, it automatically runs a user-initiated test when the battery is inserted. When the test is complete, the FR3 displays a reminder that the clock is not set and a prompt to set the date and time. To check the clock and modify it, if needed, to match local date and time, follow these steps. 1. When the FR3 displays the CLOCK NOT SET message, press the ADMINISTRATION option button to go to the ADMINISTRATION screen.* NOTE: If you do not press the option button within 20 seconds, the FR3 shuts down and goes into standby.

P H I L IP S M E D I C A L S YS T E M S

2. On the ADMINISTRATION screen, press the option button to scroll to SETUP, then press the option button to select it.

Press ON for Patient Use

Clock Not Set Set Date and Time

Battery

Good

Data Card

Good

Administration

OFF

ADMINISTRATION ##

Incident Data

#:##:##

User-Initiated Test System Information Setup Wireless Data Transfer

3. On the SETUP screen, press the option button to scroll to DATE AND TIME, then press the option button to select it.

Setup

Back Load New Setup View Setup Save Setup to Data Card Date and Time

4. On the DATE AND TIME screen, press the option button to stop the automatic time incrementing and display the CHANGE DATE AND TIME screen.

Date and Time

Back YYYY hh : mm : ss

Month

DD (24 hr)

Press DOWN ARROW to change

* If the FR3 is already in standby, press the green On/Off button to turn on the FR3. When voice prompts begin, press the button again to display the status screen.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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5. The year element of the date is highlighted when you first activate the CHANGE DATE AND TIME screen. To modify the year, press the option button until the correct value is displayed.*

Change Date and Time

Back YYYY

Month hh : mm : ss

DD (24 hr)

Press RIGHT ARROW to move Press UP ARROW to change selection

6. Press the option button to move Press CHECK when finished the highlight bar to the next element in the date or time. Press the option button to display the next value for a highlighted element. Do not press the option button until you have made all modifications needed, or the process will have to be repeated.

P H I L IP S M E D I C A L S YS T E M S

7. When you see the correct entry for the highlighted element, press the option button to move to the next element of the date and time. Repeat steps 6 and 7 for each element of the date and time you want to modify. 8. When when you have completed all the changes needed, press the option button to accept the new date and time settings. The FR3 then displays the revised DATE AND TIME screen, with BACK highlighted. 9. Press the option button to exit the screen, then press the On/Off button to display the status screen and let the FR3 go into standby. The green Ready should be flashing to show that the FR3 is ready for use. NOTE: To set the date and time using HeartStart Configure and wireless technology, see “Using HeartStart Configure and Wireless Transmission” on page 6-12.

CONNECTING THE PADS If you are NOT using an optional FR3 case with Pads Sentry, do not pre-connect the pads. Store the SMART Pads III in their unopened package with the FR3 defibrillator and ensure that the pads are protected from damage. If you ARE using an FR3 case, connect the SMART Pads III to the FR3 as follows: 1. Check the expiration date on the pads package.

* If you pass the year you wish to select, continue to press the option button to scroll through the range of years (2000 through 2030) until the correct year is displayed again.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

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2. Open the SMART Pads III package and take out the pads, leaving them on their liner. Leave the paper wrap on the coiled cable; it will tear off when you extend the cable to use the pads. WARNING: Do not peel the pads from the liner until they are needed for use in an emergency.* 3. Insert the pads connector plug firmly into the pads connector socket. 4. Check that the Pads Sentry has been installed in the FR3 system case. See page 2-2 for directions on installing the Pads Sentry in the case.

P H I L IP S M E D I C A L S YS T E M S

5. Keep the pads on their liner and insert them firmly in the Pads Sentry. The Pads Sentry shields the pads and provides a mechanism that allows the pads to be tested during each FR3 self-test. If pre-connected pads are not installed in the Pads Sentry, the FR3 will fail its self-test. Place the coiled pad cables into the compartment provided in the case. Spare pads in unopened package Pads cable storage

* Peeling any part of the pads from the liner breaks the protective seal and allows the pads adhesive to dry out. If this happens, the pads will fail the FR3 self-test.

HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

2-8

NOTE: Philips recommends that you have a spare set of pads. If you have a spare set of SMART Pads III - or are using other compatible pads that should not be pre-connected to the FR3 - do not open the pads package. Store the unopened package in the spare pads compartment in the upper lid of the FR3 system case. See “Other Compatible Defibrillator Pads” on page G-8 for a list of compatible pads.

STORING THE OPTIONAL INFANT/CHILD KEY The optional FR3 Infant/Child Key is supplied with a tether cable designed to secure the Key to an FR3 system case, if used. The tether is not required for use of the Infant/Child Key. To use the tether, follow these steps: 1. Insert the tether through the hole in the top of the Infant/Child Key.

P H I L IP S M E D I C A L S YS T E M S

2. Thread the “winged” end of the tether (A) through the single hole in its other end (B).

A

1

B

3. Straighten out the tether and tighten the loop around the Key. 4. Insert the “winged” end of the tether into the slot inside the Infant/Child Key compartment in the upper lid of the case at a 45º angle. Feed the tether into the slot, then snap the Key into the compartment.

2

3

45°

4 HEARTSTART FR3 INSTRUCTIONS FOR ADMINISTRATORS

2-9

NOTE: Do not install the FR3 Infant/Child Key in the FR3 defibrillator except when it is needed for use in an emergency. If the Key is left installed when the FR3 goes into standby, the next FR3 self-test will fail.

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5. For increased visibility of the Infant/Child Key, Philips recommends that you label the Infant/Child Key compartment in the FR3 case, as illustrated below, with the appropriate language(s) from the set of decals provided with the Key. The decal is designed to permit labeling in two languages for situations in which the FR3 is configured for bilingual operation.

5 STORING THE OPTIONAL FAST RESPONSE KIT The optional FR3 Fast Response Kit contains a pair of paramedics scissors, two pairs of gloves, a disposable razor, a pocket mask, and an absorbent wipe, housed in a hard plastic storage case. The FR3 rigid system case - but not the FR3 soft system case* - is designed to hold the Fast Response Kit. If you have the Fast Response Kit and are using the FR3 rigid system case, follow these steps: 1. Remove the FR3 Fast Response Kit from its packaging and check the contents. 2. Close the Fast Response Kit and slide it under the top clip in the upper case insert, then press it down into the lower clip, as illustrated below. * The zippered pouch version of the Fast Response Kit can be attached to the outside of the soft system case.

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