Philips Agilent Heartstream FR2 User manual

Agilent Heartstream FR2

Agilent Technologies

M3860A, M3861A

User’s Guide

Agilent M3860A, M3861A Heartstream FR2 Semi-Automatic External Defibrillator (AED)

The HEARTSTREAM FR2

AED

Clockwise from top right.

Battery. Disposable

battery pack used to power the H FR2. (Check local

EARTSTREAM

regulations for disposal and recycling

requirements.)

On/Off button. Turns

on the FR2 and starts voice and screen prompts. Second press turns off the FR2.

Status Indicator.

Shows you the readiness status of the

EARTSTREAM FR2.

Display screen.

Displays text prompts and incident data. The

EARTSTREAM FR2

H M3860A screen also displays the patient’s ECG.

Option buttons. Adjust the

contrast of the screen display and control special functions.

(

Beeper port. Broadcasts alert

beeps when required. It is located under the right edge of the FR2.

)

Infrared (IR) communications port.

A special lens, or “eye,” used to transfer data directly to or from another device.

Data card port. Receptacle for

data card tray.

Data card (optional). Used to

store and review information about the incident, including ECG and optional voice recording.

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.

Microphone. Used optionally to

record surrounding audio during an incident. It is located under the right edge of the FR2.

Shock button. Controls shock

delivery. The button flashes when

EARTSTREAM FR2 is ready to

the H deliver a shock.

B C

G H

Speaker. Amplifies voice

prompts during use of the FR2.

Pads placement diagram.

Illustrates correct placement of pads. Diagrams are also shown on

the back of the defibrillation pads.

Defibrillator pads connector port.

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

Defibrillator pads assembly. Self-

adhesive pads with attached cable and connector.

HEARTSTREAM FR2 AED

QUICK REFERENCE GUIDE

PATIENT IS UNRESPONSIVE,

NOT BREATHING, WITHOUT A PULSE

TURN ON

PROMPTS

PRESS SHOCK BUTTON

IF INSTRUCTED

Notice

About This Edition

The information in this guide applies to the Agilent Technologies models M3860A and M3861A

EARTSTREAM FR2 semi-automatic

H external defibrillator. This information is subject to change without notice.

Agilent Technologies shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Edition History

Edition 5 Publication date: September 2000 Publication number: M3860-91900 Assembly number: 011120-0005 Printed in the U.S.A.

Agilent Technologies, Inc.

This document may not be photocopied, reproduced, or translated to another language without prior written consent of Agilent Technologies.

Authorized EU Representative:

Agilent Technologies Deutschland GmbH Health Care Solutions Group Herrenberg Strasse, 130 D 71034 Boeblingen, Germany (+49) 7031-14-5151

CAUTION

FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

EARTSTREAM FR2 is designed

The H to be used only with Agilent Technologies-approved accessories.

EARTSTREAM FR2 will perform

The H improperly if non-approved accessories are used.

United States

Agilent Technologies, Inc. Healthcare Solutions Group Heartstream Operation 2401 Fourth Avenue, Suite 500 Seattle, Washington 98121-1436 (206) 664-5000 1-800-263-3342

Canada:

Agilent Technologies, Inc. 5150 Spectrum Way Mississauga, Ontario L4W 5G1 1-800-291-6743

Europe, Middle East and Africa:

Agilent Technologies Deutschland GmbH Healthcare Solutions Group Sales & Marketing Center Herrenberg Strasse, 130 D 71034 Boeblingen, Germany (+49) 7031-14-5151

Australia:

Agilent Technologies Australia Ltd. (A.C.N. 004 394 763) 1800 033 397

Latin America:

Agilent Technologies Latin America Montañeses 2140 (1428) Capital Federal Bs. As, Argentina 54-11-4787-7257

Asia Pacific Headquarters:

Agilent Technologies Asia Pacific Ltd. 24/F Cityplaza One 1111 King’s Road, Taikoo Shing Hong Kong (+852) 2599 7777

www.agilent.com/healthcare/heart

Contents

1 Introduction to the HEARTSTREAM FR2

What is the HEAR TSTREAM FR2? ................................................................................................................1-1

When Is the H How Does the H How Is the H

2 Preparing Your HEARTSTREAM FR2 for Use

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

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

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

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

Placing and Securing the H

3 Using Your HEARTSTREAM FR2

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

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

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

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

4 Maintaining, Testing, and Troubleshooting Your HEARTSTREAM FR2

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

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

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

Cleaning the H

Operator’s Checklist ........................................................................................................................... 4-3

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

Battery Insertion Selftest ................................................................................................................... 4-5

Periodic Selftests ................................................................................................................................4-9

Device History .....................................................................................................................................4-9

Battery History .................................................................................................................................... 4-9

Troubleshooting Guide ..............................................................................................................................4-10

Status Indicator Summary .................................................................................................................4-11

Status Indicator Details .....................................................................................................................4-12

Battery and Training & Administration Pack .................................................................................4-15

Defibrillation Pads .............................................................................................................................. 4-15

Rhythm Analysis and Defibrillation .................................................................................................4-16

EARTSTREAM FR2 Used? .....................................................................................................1-1

EARTSTREAM FR2 Work? ................................................................................................ 1-2

EARTSTREAM FR2 Supplied? ................................................................................................1-2

EARTSTREAM FR2 ......................................................................................... 2-4

EARTSTREAM FR2 ........................................................................................................ 4-3

Contents

5 Clinical and Safety Considerations

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

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

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

Safety Considerations ............................................................................................................................... 5-2

General Dangers, Warnings, and Cautions ..................................................................................... 5-2

Defibrillation Warnings and Cautions .............................................................................................5-4

Monitoring Cautions ........................................................................................................................... 5-5

Maintenance Cautions ........................................................................................................................ 5-5

6 Setup and Advanced Mode Features

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

Non-Protocol Parameters ...................................................................................................................6-1

Automatic Protocol Parameters ....................................................................................................... 6-2

Manual Override Parameters ............................................................................................................ 6-4

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

Reviewing Current Setup ...................................................................................................................6-6

Revising Setup ..................................................................................................................................... 6-7

Receiving Setup ................................................................................................................................... 6-7

Reading Setup ...................................................................................................................................... 6-8

Sending and Receiving Clock Settings ....................................................................................................6-9

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

Using the Manual Analyze Feature ..................................................................................................6-11

Using the Manual Charge Feature (M3860A only) .........................................................................6-11

7 Data Management and Review

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

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

Recording Data in Internal Memory ................................................................................................. 7-1

Recording Data on a Data Card ........................................................................................................7-1

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

Reviewing Data from Internal Memory ...........................................................................................7-3

Reviewing Data from a Data Card ....................................................................................................7-3

A Accessories for the HEARTSTREAM FR2

B Technical Specifications

C Differences between the FORERUNNER and the HEARTSTREAM FR2 AEDs

D Glossary of Symbols and Controls

E Glossary of Terms

F Clinical Summary

Index

Contents

iii

Contents

Notes

1 Introduction to the HEARTSTREAM FR2

What is the HEARTSTREAM FR2?

The HEARTSTREAM FR2 defibrillator (“FR2”) is a semi-automatic external defibrillator (AED). It is compact, lightweight, portable, and battery powered. It is designed for simple and reliable operation by a trained responder.

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

The H 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 HEARTSTREAM FR2 is available in two models, the M3860A and the M3861A. They share a set of basic features. In addition, the M3860A provides optional screen display of the patient’s electrocardiogram (ECG) and can be programmed to permit the advanced mode’s manual charge feature.

NOTE: The FR2 comes with a factory default setup that can be modified. (See Chapter 6, Setup and Advanced Mode Features, for a description of setup defaults and options.)

When Is the HEARTSTREAM FR2 Used?

The HEARTSTREAM FR2 is used with disposable HEARTSTREAM defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): lack of responsiveness, lack of breathing, and lack of detectable pulse.

Defibrillation should not be performed on anyone who is responsive, is breathing, or has a detectable pulse.

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 1-1

How Does the HEARTSTREAM FR2 Work?

The HEARTSTREAM FR2 is intended for use by emergency care personnel who have been specifically trained in the operation of the H qualified by training in Basic Life Support (BLS), in Advanced Life Support (ALS), or in other physician-authorized emergency medical response.

The HEARTSTREAM FR2 is not intended for administration of energy at pediatric energy settings. In accordance with the recommendations of the American Heart Association, but standard operating procedures should be followed in treating children over eight years of age.

How Does the HEARTSTREAM FR2 Work?

The HEARTSTREAM FR2 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 defibrillation pads that are properly applied to the patient’s bare chest, the H

1. prompts you to take specific actions,

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

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

Detailed instructions for use are provided in Chapter 3.

EARTSTREAM FR2 or who are

the HEARTSTREAM FR2 should not be used to treat infant cardiac arrest,

EARTSTREAM FR2:

not the rhythm is shockable, and

biphasic electric pulse designed to defibrillate the heart.

How Is the HEARTSTREAM FR2 Supplied?

The HEARTSTREAM FR2 is supplied with a battery pack, defibrillation pads with integrated cable and connector, and a data card tray. Other accessories are available. See Appendix A for a list of accessories and other recommended supplies.

* Textbook of Advanced Cardiac Life Suppor t. Dallas: AHA, 1997-99.

1-2 Introduction to the H

EARTSTREAM FR2

2 Preparing Your HEARTSTREAM FR2 for Use

Overview

There are a few basic steps to preparing your HEARTSTREAM FR2 for use:

 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, and that the factory default settings will not be changed. Exceptions to this sequence are provided elsewhere in this User’s Guide.

Installing the Battery

The HEARTSTREAM FR2 is shipped with a M3863A battery pack. The battery is enclosed in a gray plastic case. There is a yellow latch at one end that holds the battery pack in place when it is correctly installed in the FR2.

Before installing the battery, make sure the defibrillation pads are not connected to the FR2. To install the battery:

1. Hold the battery pack by the latch end and slide it into the battery compartment at the top of the H

2. Slide the battery all the way into the opening, until the latch clicks into place. The latch will click into place only when the battery is inserted correctly.

CAUTION: Follow all instructions supplied with the HEARTSTREAM M3863A battery pack. Install the battery before the expiration date shown on the battery.

When the battery is installed, the H Status Indicator displays a flashing black hourglass. The Shock button light and the indicator light for the defibrillation pads connector port turn on briefly.

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 2-1

EARTSTREAM FR2.

EARTSTREAM FR2 automatically turns on. The

Setting the Clock

RUN SELFTEST

REVIEW INCIDENT

NO DATA CARD

GOOD BATTERY

IN EMERGENCY

PRESS OFF TO QUIT

DEVICE HISTORY

BATTERY HISTORY

SETUP CLOCK

RETURN

IN EMERGENCY

PRESS OFF TO QUIT

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.)

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

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

• Press the LOWER Option button to move the highlight bar from one item to another on the menu.

• Press the UPPER Option button to select the highlighted item or to scroll through the settings for that item.

If you select NEXT, the menu displayed lets you review the history of the FR2, review the history of the battery being used, access setup data, set the clock, or return to the first menu. (See Chapter 4, Maintaining, Testing, and Troubleshooting Your

EARTSTREAM FR2, for details about the review options and Chapter 6, Setup and

H Advanced Mode Features, for information on the setup option.)

NOTE: If you make no selection for 10 seconds, the selftest will automatically run. If you want to select something different from either of these menus, you must

do so before the selftest begins, or remove and reinstall the battery to bring up the main menu. You can press the On/Off button at any time to turn off the FR2 and return it to standby (ready for use) mode. To use the FR2 when it is in standby mode, press the On/Off button to turn it on.

Setting the Clock

It is recommended that the first time you prepare your HEARTSTREAM FR2 for use,

RUN SELFTEST

REVIEW INCIDENT

NO DATA CARD

GOOD BATTERY

IN EMERGENCY

PRESS OFF TO QUIT

2-2 Preparing Your H

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:

EARTSTREAM FR2 for Use

DEVICE HISTORY

BATTERY HISTORY

SETUP

CLOCK

RETURN

IN EMERGENCY

PRESS OFF TO QUIT

Setting the Clock

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 H

EARTSTREAM FR2.

NOTE: The date is displayed as day (DD), month (MM), and year (YY), as shown on the screen. The time is displayed using the 24-hour international clock.

CLOCK

RETURN

RECEIVE TIME

SEND TIME

07 / 09 / 00

DD / MM / YY

14 : 28

CLOCK

RETURN

RECEIVE TIME

SEND TIME

07 / 09 / 00

DD / MM / YY

14 : 28

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 HEARTSTREAM FR2 or from a computer

using C

ODERUNNER® software, using the RECEIVE TIME option. This may be

used to synchronize the clocks of several FR2s. 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.

To manually set the clock:

1. Use the lower Option button to move the highlight bar to the part of the clock setting you want to change.

2. Press the upper Option button repeatedly to scroll through the settings until you reach the one you want. If you go past it, keep scrolling until it comes up again.

3. Use the lower Option button to select the next part you want to change, and repeat the process, until all parts of the date and time have been set.

4. When you have made all the changes, move the highlight bar to RETURN and press the upper Option button to go back to the main menu screen.

NOTE: New clock settings are used by the FR2 as soon as you set them. The clock time display is updated each minute this screen is displayed. The clock seconds, although not displayed, are set to 00 when you move the highlight bar out of the time settings.

M3860A and M3861A H

NOTE: If the battery is removed from the FR2 for more than two hours, the clock settings will be lost and must be reset.

EARTSTREAM FR2 Defibrillator 2-3

Running the Battery Insertion Selftest

RUN SELFTEST

REVIEW INCIDENT

NO DATA CARD

GOOD BATTERY

IN EMERGENCY

PRESS OFF TO QUIT

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 defibrillation pads are not connected to the FR2 before running the battery insertion selftest.

The selftest has two parts. The first part tests the FR2 circuitry and memory. 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 H working properly. (See Chapter 4, Maintaining, Testing, and Troubleshooting Your

EARTSTREAM FR2, for details about this selftest.)

To run the selftest:

1. Make sure the FR2 has not been in use for at least 5 minutes, and that the defibrillation pads are not connected to the device.

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

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

4. Make no selection for 10 seconds, and the selftest will start automatically.

EARTSTREAM FR2 are

NOTE: If you connect defibrillation pads (that are applied to the patient) to the FR2 during a battery insertion selftest, the selftest will stop so that the FR2 is in standby (ready for use) mode.

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

SELFTEST PASSED

REV: XXX X.X XXXX

NO DATA CARD

SN 000000001

IN EMERGENCY

PRESS OFF TO QUIT

interactive part of the selftest. (See Chapter 4, Maintaining, Testing, and Troubleshooting Your H

EARTSTREAM FR2, for details about the interactive part of the

test.)

When the selftest is complete, the H

EARTSTREAM FR2 automatically turns off and

returns to standby mode. In the standby mode, the FR2 is ready for use at any time, simply by pressing the On/Off button to turn it on.

Placing and Securing the HEARTSTREAM FR2

Place the HEARTSTREAM FR2 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. (See Appendix A for a list of accessories.)

2-4 Preparing Your H

EARTSTREAM FR2 for Use

Placing and Securing the HEARTSTREAM FR2

NOTE: Do not store the FR2 with the defibrillation 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 H 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 H

EARTSTREAM FR2 performs detailed periodic selftests, to make sure

EARTSTREAM FR2, for instructions.)

M3860A and M3861A H

EARTSTREAM FR2 Defibrillator 2-5

Placing and Securing the HEARTSTREAM FR2

Notes

2-6 Preparing Your H

EARTSTREAM FR2 for Use

3 Using Your HEARTSTREAM FR2

Overview

This chapter describes how to use the HEARTSTREAM FR2 in an emergency incident. Some general things to remember are:

 Try to relax and stay calm. The HEARTSTREAM FR2 automatically provides

appropriate voice and display prompts to guide you.

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

pads have a layer of sticky, conductive gel beneath the protective backing. To work effectively, the gel must not be dried out.

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

chest hair to provide good contact between the defibrillation pads and the patient’s skin.

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

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

H Troubleshooting Your H the Warnings and Cautions on the last page of this chapter.

EARTSTREAM FR2, for troubleshooting tips.) Be sure to read

NOTE: These directions apply to both the model M3860A and the model M3861A HEARTSTREAM FR2, except where otherwise noted.

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 3-1

Step 1: Preparation

•

Press the On/Off button to turn on the HEARTSTREAM FR2. Follow the instructions provided by the FR2 voice and screen prompts in the order indicated.

Remove clothing from the patient's chest. Wipe moisture from the patient's chest and clip or shave excessive chest hair, if necessary.

Open the defibrillation pads package. Check to see that the pads and attached cable and connector are undamaged. Pull off the protective backing from the defibrillation pads and check that the gel has not dried out. If the pads are damaged or the gel has dried out, use a new set of pads.

Place each pad on the patient. The pads must be placed with the sticky side on the patient’s skin. IMPORTANT: Refer to the drawing on the back of each pad for correct positioning. 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.

Connect the pads to the HEARTSTREAM FR2. Insert the defibrillation pads connector firmly in the connector socket. A flashing light shows you where the socket is located, at the top left of the H

EARTSTREAM FR2.

3-2 Using Your H

EARTSTREAM FR2

Step 2: ECG Analysis and Monitoring

Follow the instructions provided by the HEARTSTREAM FR2 voice and screen prompts in the order indicated.

As soon as the FR2 detects that the defibrillation pads are connected properly, it automatically begins analyzing the patient’s heart rhythm. The H model M3860A can display the patient’s ECG on the screen. When the ECG display is enabled, the patient’s heart rate is also displayed during background monitoring.ECG and patient heart rate are always displayed when the advanced mode is entered.

EARTSTREAM FR2

If no shock is advised, the H tell you so. The FR2 instructs you to perform CPR if needed, and performs background monitoring of the patient’s ECG while you give appropriate care to the patient. These instructions are repeated at the programmed Monitor Prompt interval (the default interval is one minute) while the FR2 is monitoring the patient.

NOTE: CPR may interfere with background monitoring. During CPR, periodically pause for 15 seconds to check the patient and allow the FR2 to analyze the patient’s heart rhythm without CPR artifact.

Monitoring continues until and unless the H patient’s heart rhythm that may be a shockable rhythm, detects interference with rhythm analysis, or is turned off.

If the HEARTSTREAM FR2 detects a potentially shockable heart rhythm, it automatically goes back to analyzing the rhythm to see if a shock is advised.

If a shock is advised, the H gives the voice warnings and screen prompts to tell you that a shock is advised. Make sure that no one is touching the patient. While the H continues to analyze the patient’s heart rhythm. If the rhythm changes and a shock is no longer appropriate, the H Voice and display prompts advise you what action to take.

NOTE: When the HEARTSTREAM 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.)

EARTSTREAM FR2 provides voice and screen prompts to

EARTSTREAM FR2 detects a change in the

EARTSTREAM FR2 charges to prepare for shock delivery. It

EARTSTREAM FR2 is charging, it

EARTSTREAM FR2 disarms and dumps the charge.

M3860A and M3861A H

EARTSTREAM FR2 Defibrillator 3-3

Step 3: Shock Delivery

Press the Shock button to deliver the shock.

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

EARTS TREAM FR2 will not automatically deliver a shock.

There are four ways you can tell that the HEARTSTREAM 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.

EARTSTREAM FR2 goes back to analyzing the patient’s heart rhythm to see if

Then H the shock was successful. The H prompts to guide you through additional shocks, if appropriate.

NOTE: If you do not press the Shock button within 30 seconds of being prompted, the FR2 will disarm itself and provide a pause for CPR. The device will resume analyzing at the end of the pause period or when the Resume Analyzing key is pressed.

EARTSTREAM FR2 continues to provide voice and text

Pause for CPR. After the programmed number of shocks in a shock series are delivered, the H

EARTSTREAM 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 H

EARTSTREAM model M3860A

displays the ECG, if enabled, during this period.

3-4 Using Your H

EARTSTREAM FR2

Step 3: Shock Delivery

WARNING: Do not place the defibrillation pads on the patient’s chest and back (anterior-posterior). The algorithm used by the H anterior-posterior pads placement.

WARNING: Do not let the defibrillation pads touch each other or other ECG electrodes, lead wires, dressings, transdermal patches, etc. Such contact can cause electrical arcing and patient skin burns during defibrillation and may divert defibrillating current away from the heart.

WARNING: During defibrillation, air pockets between the skin and defibrillation pads can cause patient skin burns. To help prevent air pockets, make sure defibrillation pads completely adhere to the skin. Do not use dried-out defibrillation pads.

WARNING: Handling or transporting the patient during heart rhythm analysis can cause an incorrect or delayed diagnosis. If the H the patient as still as possible for at least 15 seconds so the H rhythm analysis before a shock is delivered.

EARTSTREAM FR2 gives a SHOCK ADVISED prompt, keep

EARTSTREAM FR2 has not been validated with

EARTSTREAM FR2 can reconfirm the

M3860A and M3861A H

WARNING:

compressions per minute can cause incorrect or delayed analysis by the HEARTSTREAM FR2.

WARNING:

patient during defibrillation. Do not allow the defibrillation pads to touch any metal surfaces. Disconnect the pads connector from the HEARTSTREAM FR2 before using any other defibrillator.

CAUTION:

defibrillation pads if they become damaged.

EARTSTREAM FR2 Defibrillator 3-5

CPR rates significantly above the American Heart Association guidelines of 100

Defibrillation current can cause operator or bystander injury. Do not touch the

: Aggressive handling of the pads in storage or prior to use can damage the pads. Discard the

: :

Step 3: Shock Delivery

Notes

3-6 Using Your H

EARTSTREAM FR2

4 Maintaining, Testing, and Troubleshooting

Your HEARTSTREAM FR2

Overview

This chapter provides information on HEARTSTREAM FR2 maintenance, detailed descriptions of the selftests, and a guide to troubleshooting.

Maintenance

Maintenance Schedule

Maintenance of the HEARTSTREAM FR2 is very simple, but it is a very important factor in its dependability. The H activities itself. These include daily and weekly selftests to verify readiness for use and more detailed monthly selftests that also verify the shock waveform delivery system. In addition, a detailed selftest is run whenever a battery is installed in the FR2.

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

The H

EARTSTREAM FR2 has no user-serviceable parts.

EARTSTREAM FR2 performs many maintenance

CAUTION:

Maintain the H Medical Director.

CAUTION: Electrical shock hazard. Dangerous high voltages and currents are present. Do not open the H HEARTSTREAM FR2. The HEARTSTREAM FR2 should be returned to an authorized service center for repair.

The following table presents a schedule of suggested maintenance for the H

M3860A and M3861A HEARTSTREAM FR2 Defibrillator 4-1

: Improper maintenance may damage the HEARTSTREAM FR2 or cause it to function improperly.

: :

EARTSTREAM FR2 only as described in this User's Guide or as designated by your program's

EARTSTREAM FR2, remove its covers, or attempt repair. There are no user-serviceable components in the

EARTSTREAM FR2.

Maintenance

Daily

Monthly

✰✰

After

Each Use

✰

Check the Status Indicator.

If you see the flashing black hourglass:

• The HEARTSTREAM FR2 is ready to use. No action required.

If you see anything other than a flashing black hourglass, remove and reinstall the battery to run the selftest.

• If the selftest passes and the Status Indicator shows the flashing black hourglass, the HEARTSTREAM FR2 is ready to use.

• If the selftest fails, install a new battery and run the selftest. If the selftest passes, the H Agilent Technologies for technical support.

Check supplies, accessories, and spares for damage and expiration dating.

If a LOW BATTERY or REPLACE BATTERY message is displayed:

• Replace the battery and run the selftests. DO NOT ATTEMPT TO CHARGE THE M3863A BATTERY. It is not rechargeable.

If supplies, accessories, or spares are damaged or have expired:

• Do not use damaged or expired accessories. Replace them immediately.

Check the operation of the FR2 by removing and reinstalling the battery and running the battery insertion selftest. Note: Perform also when replacing

expired pads.

Check the outside of the HEARTSTREAM FR2 and the connector socket for cracks or other signs of damage.

If you see signs of damage:

• Contact Agilent Technologies for technical support.

MAINTENANCE TASK/RESPONSE

EARTSTREAM FR2 is ready to use. If the selftest fails, contact

✰

4-2 Maintaining, Testing, and Troubleshooting Your H

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.

Check the outside of the HEARTSTREAM FR2 and the connector socket for signs of dirt or contamination.

If the HEARTSTREAM FR2 is dirty or contaminated:

• Clean it according to the guidelines provided in this User’s Guide.

EARTSTREAM FR2

Maintenance

Daily

Monthly

After

Each Use

✰

MAINTENANCE TASK/RESPONSE

Check the connector socket to make sure that defibrillation pads are disconnected from the H

Check to make sure the data card tray is installed, even if a data card is not being used.

EARTSTREAM FR2 when it is not in use.

Cleaning the HEARTSTREAM FR2

The outside of the HEARTSTREAM FR2, including the defibrillator pads connector port, 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 HEARTSTREAM FR2 in fluids.

 Make sure a battery (or the Training & Administration Pack) and a data card

tray are installed when cleaning the H device.

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

acetone-based cleaners, or enzymatic cleaners.

 Clean the HEARTSTREAM FR2 and the connector socket with a soft cloth

dampened with one of the cleaning agents listed below.

— Isopropyl alcohol (70% solution) — Soapy water — Chlorine bleach (30 ml/l water) — Ammonia-based cleaners — Glutaraldehyde-based cleaners — Hydrogen peroxide

CAUTION:::: Do not immerse any portion of the HEARTSTREAM FR2 in water or other fluids. Do not allow fluids to enter the H into the H FR2 or accessories.

EARTSTREAM FR2. Avoid spilling any fluids on the HEARTSTREAM FR2 or accessories. Spilling fluids

EARTSTREAM FR2 may damage it or present a fire or shock hazard. Do not sterilize the HEARTSTREAM

EARTSTREAM FR2, to keep fluids out of the

M3860A and M3861A H

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 HEARTSTREAM 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.

EARTSTREAM FR2 Defibrillator 4-3

Maintenance

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.

OPERATOR'S CHECKLIST

HEARTSTREAM FR2 Model No.: _________________________Serial No.: ___________________________________________

HEARTSTREAM FR2 Location or Vehicle ID: __________________________________________________________________

DATE

SCHEDULED FREQUENCY

EARTSTREAM FR2

Clean, no dirt or contamination; no signs of damage

Supplies Available

• Two sets defibrillation pads, sealed, undamaged, within expiration date

• Ancillary supplies (hand towel, scissors, razor)

• Spare 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

4-4 Maintaining, Testing, and Troubleshooting Your H

EARTSTREAM FR2

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