FORERUNNER EM User Guide

Download

UNNER

ORE

Initiates voice

and screen prompts. Press again to turn off.

TATUS

Shows when the

UNNER

ORE

NDICATOR

is ready

to use based on automatic self tests.

ATCH

ATTERY

Slide

to eject the battery.

•

ICROPHONE

Located behind the battery latch. Records voice information when optional PC voice data card is installed.

RIDE

UTTON

(Available

ANUAL

PTIONAL

on Model EM only) Permits qualiﬁed users

VER-

to manually charge the

and deliver

UNNER

ORE

a shock.

E C

ONTRAST

UTTONS

Adjust LCD screen contrast and are used to

I H

control other functions.

ISPOSABLE

ATTERY

ECYCLABLE

Provides

power for the

UNNER

ORE

ATA

PTIONAL ARD

PC D

Stores ECG and event data. An optional card can also store voice data. Separate cards provide setup and training options.

Displays

H LCD S

CREEN

text prompts and patient/event information. ECG and heart rate can be displayed on Models E and

HOCK

UTTON

Controls shock delivery. The button ﬂashes when the F

UNNER

is ready

ORE

to deliver a shock.

PEAKER

Provides audible instructions and information about the F

UNNER

and the

ORE

patient’s status.

EFIBRILLATION

LLUSTRATION

ONNECTOR

LACEMENT

OCKET

Insert the deﬁbrillation

EFIBRILLATION

ADS

Disposable and self adhesive. Deﬁbrillation pads include attached cable and connector.

pads connector into the connector socket. The LED ﬂashes to indicate the socket location. The LED is covered when the deﬁbrillation pad connector is properly inserted in the socket.

EM.

ORE

UNNER

EMI-AUTOMATIC

ODE

UICK

EFERENCE

semi-automatic deﬁbrillator

User’s Guide

For

Model S

Model E

Model EM

Heartstream, the Heartstream logo, F R

UNNER

logo, and C

ODE

UNNER

are either registered trade-

ORE

UNNER

, the F

ORE-

marks or trademarks of Hewlett-Packard Company in the United States and/or other countries.

The F

ORE

UNNER

semi-automatic deﬁbrillator is sold in some markets as the Laerdal Heartstart FR. Laerdal and Heartstart are registered trademarks of Laerdal Medical Corporation.

ORE

Heartstream F

as used in this document, refers to either the HP

UNNER

ORE

UNNER

semi-automatic deﬁbrillator or the

Laerdal Heartstart FR.

Speciﬁcations are subject to change without notice.

Published in the U.S.A.

CAUTION:

of a physician.

Federal law (USA) restricts this device to sale by or on the order

ii F

ORE

UNNER

ABLE

ONTENTS

Introduction 1

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Dangers, Warnings, and Cautions . . . . . . . . . . . . . . . . . . . . . . 4

Putting the F

How to Put the F

Battery Installation and the Battery Insertion Test . . . . . . . . 6

Status Indicator and Automatic Self Tests . . . . . . . . . . . . . . 10

Using the F

Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Analysis and Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Semi-automatic Delivery of Defibrillation Shock . . . . . . . . . 17

Pause for CPR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Manual Delivery of Defibrillation Shock . . . . . . . . . . . . . . . 19

Error Conditions, Possible Causes, and Corrective Actions. 21

Continued Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

ORE

UNNER

into Service 5

into Service . . . . . . . . . . . . . . . 5

Maintaining the F

ORE

UNNER

ORE

Self Tests and F

Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Automated Defibrillators: Operator’s Check List . . . . . . . . . 30

UNNER

Maintenance . . . . . . . . . . . . . . 25

Event Review Storage and Retrieval 31

Installing the Optional PC Data Card . . . . . . . . . . . . . . . . . . 31

Event Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

User’s Guide

iii

ORE

F Using the F

ABLE

ORE

UNNER

ONTENTS

Options 37

Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

ORE

Setup Card . . . . . . . . . . . . . . . . . . . 38

UNNER

Configuring Setup Options. . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Training Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Specifications 45

Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Heartstream Clinical Summary and American Heart Associa-

tion Defibrillation Statement . . . . . . . . . . . . . . . . . . . . . . . 55

Service and Replaceable Parts . . . . . . . . . . . . . . . . . . . . . . . . 57

Glossary of Symbols 59

RUNNER Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

ORE

Screen Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

PC Card Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Battery Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64

Dangers, Warnings, and Cautions 65

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66

Defibrillation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Monitoring. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

ORE

UNNER

C HAPTER ONE

Introduction

his User’s Guide provides information for trained operators about using and maintaining the

deﬁbrillator (AED). This chapter presents general information that you should know before you begin using the F

VERVIEW

ORERUNNER semi-automatic external

ORERUNNER.

The FORERUNNER semi-automatic deﬁbrillator is lightweight, portable, and battery powered. It performs

Overview

Indications

Contraindications

Dangers, Warnings, and Cautions

User’s Guide 1

User’s Guide

automatic self tests and displays the results of these tests on a Status Indicator. The F screen that displays text prompts, patient and event information, and on some models, an electrocardiogram (ECG).

ORERUNNER has an LCD

C HAPTER ONE

Introduction

When connected with Heartstream deﬁbrillation pads to a patient who is unconscious, not breathing, and without a pulse, the F

ORERUNNER:

•prompts you to take speciﬁc actions,

• automatically analyzes the patient’s ECG,

• indicates whether a shockable rhythm is present, and if so,

• arms the shock button.

You can deliver the deﬁbrillation shock by pressing the ﬂashing shock button . The F

ORERUNNER will not deliver

a shock unless the shock button is pressed.

The F

ORERUNNER detects ECG signals and delivers the

deﬁbrillation shock using two self adhesive deﬁbrillation pads. The deﬁbrillation pads, cable, and connector are supplied as one disposable assembly.

See Appendix B for information about shockable rhythms.

The FORERUNNER determines proper deﬁbrillation pad contact by monitoring impedance between the two attached deﬁbrillation pads. The F

ORERUNNER recognizes a shockable

rhythm (ventricular ﬁbrillation or certain ventricular tachycardia) based on an ECG analysis system.

The deﬁbrillation shock is delivered using an impedance compensated biphasic waveform with a minimum of 130 Joules delivered to a 50 ohm load. Power is provided by a disposable, recyclable sealed lithium battery installed in the side of the F

ORERUNNER.

Voice prompts provide instructions and patient information, and are reinforced by messages on the LCD screen. Adjacent pushbuttons control the F

ORERUNNER.

An optional manual override button is available (Model EM only) for qualiﬁed users. It overrides the ECG analysis system and permits the operator to manually charge the F

ORERUNNER and deliver a shock.

2 FORERUNNER

FORERUNNER

C HAPTER ONE

Introduction

Optional PC data cards can record event information, ECG, voice, and other audible activity. Data stored on a card can be reviewed and reports can be generated using a personal computer. Optional training and setup cards allow the F

ORERUNNER to perform additional training and setup

functions.

NDICATIONS

The FORERUNNER, in semi-automatic or manual override mode, is indicated for use on victims of sudden cardiac arrest on whom an apparent lack of circulation is indicated by:

• Unconsciousness

• Absence of breathing

• Absence of detectable pulse

The F

ORERUNNER is for use by emergency care personnel

speciﬁcally trained in the operation of the F

ORERUNNER and

qualiﬁed by training in advanced cardiac life support, in basic life support, or in other physician-authorized emergency medical response. The F

ORERUNNER must be

used by or on the order of a physician.

Refer to the chapter on event review storage and retrieval for detailed information about using PC data cards and other options.

The F

ORERUNNER was not designed or tested to interpret

pediatric arrhythmias or administer energy at pediatric joule settings. For children older than 8 years, the American Heart Association recommends that standard operating procedures for AEDs be followed. American Heart Association. Textbook of Advanced Cardiac Life Support. Dallas, Tex: AHA;

1994.

User’s Guide 3

C HAPTER ONE

Introduction

CONTRAINDICATIONS

The FORERUNNER is contraindicated for use on patients exhibiting any one of the following:

• Consciousness

•Presence of breathing

•Presence of detectable pulse

ANGERS, WARNINGS, AND CAUTIONS

This manual contains a list of danger, warning, and caution messages in Appendix D. These terms are used throughout this User’s Guide or on the F

ORERUNNER. Please familiarize

yourself with their deﬁnitions and signiﬁcance.

4 FORERUNNER

C HAPTER TWO

Putting the FORERUNNER into Service

ou need three items to put the FORERUNNER into service: the F

with attached cable and connector. When you put the F that you carry a spare package of deﬁbrillation pads, a spare battery, and a spare PC data card if the F uses this option.

package containing the deﬁbrillation pads

ORERUNNER into service, however, it is recommended

ORERUNNER, its battery, and the

ORERUNNER

How to Put the

ORERUNNER into Service

Battery Installation and

the Battery Insertion Test

Status Indicator and

Automatic Self Tests

User’s Guide 5

User’s Guide

OW TO PUT THE FORERUNNER INTO SERVICE

The FORERUNNER is shipped with standard factory settings and without a PC data card. The settings should be reviewed against your program’s protocol and changed as needed. Failure to conﬁgure settings correctly may adversely affect use of the F

Installing a PC data card is optional.

ORERUNNER.

C HAPTER TWO

Putting the FORERUNNER into Service

To put the FORERUNNER into service using the standard factory settings and no PC data card:

For information about setup options and changing the factory settings, see Appendix A. For information about installing and using PC data cards, see the chapter on event review storage and retrieval.

CAUTION: Follow all battery

labeling instructions. Install the battery prior to the date noted on the battery.

1. Insert the battery and perform the Battery Insertion Test (BIT) as described on the following pages.

2. Put the F

ORERUNNER in an accessible area with the

Status Indicator easily visible. See Appendix B for the environmental standby storage speciﬁcations.

3. Observe the Status Indicator daily and as described later in this chapter.

ATTERY INSTALLATION AND THE BATTERY INSERTION TEST

When you are ready to put the FORERUNNER into service, install the battery as shown below. Snap the battery into place using a single motion and ﬁrm pressure. The battery should “click” into place when it is properly inserted.

•

6 FORERUNNER

FORERUNNER

Putting the FORERUNNER into Service

The Battery Insertion Test (BIT)

C HAPTER TWO

At the time you install a battery, the FORERUNNER automatically performs a comprehensive self test called the Battery Insertion Test (BIT).

The BIT has two parts: an automatic self test followed by an interactive test. During the automatic part of the BIT, the screen displays information about the progress of the self test. No user interaction is required during the automatic part of the BIT.

If the screen displays a message that a previous self test has failed, the F

ORERUNNER must complete a BIT before being

put into service. A message will also be displayed if the F

ORERUNNER has been stored outside of the recommended

standby temperature range since the last BIT was completed. Storing the F

ORERUNNER outside of the standby temperature

and environmental speciﬁcations noted in Appendix B will shorten battery life and prevent the F

ORERUNNER from

performing self tests.

The FORERUNNER performs a complete BIT when you install a battery unless:

•

• In an emergency, you press the On/Off button

stop the BIT.

• Deﬁbrillation pads are attached to a patient, indicating that the F

ORERUNNER is in use.

• Less than ﬁve minutes have passed since the last use, indicating that it is likely the F

ORERUNNER is still

in use.

• The F

ORERUNNER detects that a Training card or a

Setup card is installed.

• The battery is completely depleted.

• The F

ORERUNNER is outside of the operating

temperature speciﬁcation.

If any portion of the BIT fails, replace the battery with a new battery and repeat the BIT. If any portion of the second BIT fails, remove the FORERUNNER from service and contact Heartstream Customer Service.

The Status Indicator tells you if the FORERUNNER passed the BIT. See the section later in this chapter titled

Status Indicator and Automatic Self Tests.

User’s Guide 7

C HAPTER TWO

Putting the FORERUNNER into Service

PC Data Card Veriﬁcation

The BIT automatically checks for the presence of the optional PC data card. If the PC data card is installed, the BIT verifies that the card is compatible with the F

ORE

UNNER

communicate with the card. The

and that the F

ORE

UNNER

ORE

is able to

UNNER

screen indicates whether the card has data from a previous event stored on it or is cleared of data.

The F

ORE

UNNER

screen also indicates if an optional PC

data card is not installed, if the card is incompatible with the

ORE

UNNER

, or if the F

ORE

UNNER

system is unable to

communicate with the card.

If you get a screen prompt that alerts y card error, remove the card. Ensur Heartstream PC data card and it was installed corr is a Heartstream PC data car

d and was installed corr

ou that there is a data

e that the card is a

ectly. If it

ectly, remove the card and contact Customer Service for a ne card.

Interactive Tests in the BIT

When the automatic part of the BIT and PC data car veriﬁcation are complete These tests allow you to verify the corr screen, buttons, LEDs, and speak The F

ORE

UNNER

Observe each test, follo any discrepancies. If an battery with a ne

w battery and repeat the BIT. If any portion of the second BIT fails, r service and contact Customer Service

, the BIT begins inter

active tests.

ect operation of the

er on the F

ORE

screen guides you through these tests.

w the prompts as indicated, and note

y portion of the BIT fails, r

emove the F

ORE

UNNER

. Descriptions of the

UNNER

eplace the

from

interactive tests follow.

8 FORERUNNER

C HAPTER TWO

Putting the FORERUNNER into Service

BIT Interactive Tests Description and Outcome of the Tests

Speaker/Microphone

LEDs

Contrast Buttons

LCD Screen

Shock Button

An audible test of the speaker occurs when the screen message appears. You should hear two beeps during a successful test.

Observe the two LEDs to verify that they both illuminate:

A Connector socket LED.

B Shock button LED.

Press each contrast button when the screen prompt appears. Beeps and a screen message verify the test.

Observe the test pattern on the LCD screen to verify operation and adjust the contrast as needed.

A Contrast buttons:

Press to increase contrast.

Press to decrease contrast.

Press the shock button when the screen prompt appears. A beep and screen message verify the test. Pressing the shock button will not deliver a shock during the BIT interactive test.

Manual Override Button (Model EM only)

If the FORERUNNER is equipped with a manual override button, slide the cover to expose the button. Press the manual override button when prompted. A beep and a screen message verify the test.

On/Off

•

Press On/Off when the screen prompt appears. A beep and screen message verify that the interactive portion of the BIT is complete. The FORERUNNER turns off. Observe the Status Indicator to determine if the FORERUNNER passed the BIT.

User’s Guide 9

C HAPTER TWO

Putting the FORERUNNER into Service

STATUS INDICATOR AND AUTOMATIC SELF TESTS

WARNING: The BIT and periodic self tests are designed to assess the F

ORERUNNER’s readiness for use.

However, no degree of testing can assure performance or detect abuse, damage, or a defect which occurs after the last BIT or self test is completed.

The Status Indicator displays the results of the last complete BIT or periodic self test. The BIT and self tests perform comprehensive checks of the internal electronics of the F

ORERUNNER. They do not, however, eliminate the need for

ORERUNNER maintenance as speciﬁed in this User’s Guide.

The Status Indicator has three operating conditions:

Status Indicator Condition Action

Alternates these two shapes

The FORERUNNER passed the BIT or the last periodic auto-

The FORERUNNER is ready for use.

matic self test.

Displays a ﬂashing red X accompanied by a chirping sound

The FORERUNNER requires attention. FORERUNNER use is not recommended because the

• Remove and reinstall the

FORERUNNER may not perform properly. A ﬂashing red X can indicate:

• Check to assure that the

• a low battery

• storage of the

FORERUNNER outside of the recommended standby temperature range

• If there is no "low battery"

• a self test error

battery. A screen message will tell you if the standby temperature range has been exceeded.

FORERUNNER is being stored in the recommended standby temperature range (see Appendix B).

or "replace battery" screen message, remove and reinstall the existing battery and perform the BIT. If the BIT passes, the FORERUN-

NER is ready for use. If the

BIT fails, install a new battery and repeat the BIT a second time. If the BIT passes, the FORERUNNER is ready to use. If the BIT fails, remove the FORERUN-

NER from service and con-

tact Customer Service.

10 FORERUNNER

C HAPTER TWO

Putting the FORERUNNER into Service

Status Indicator Condition Action

Displays a solid red X

Displays neither alternating hourglass, nor ﬂashing or solid red X

The FORERUNNER is not operable. Do not use the FORERUNNER. The solid red X can indicate:

• a Training card is installed

but unused for ten minutes.

• a Setup card is installed.

• the battery is missing or is

completely depleted.

• a self test detected a failure.

Possible damage to the FORERUNNER

• Remove the Training or

Setup card and reinsert the battery.

• Remove and reinstall the

battery to perform the BIT. If the BIT passes, the F

ORERUNNER is ready for

use. If the BIT fails, install a new battery and repeat the BIT a second time. If the BIT passes, the

ORERUNNER is ready to

F use. If the BIT fails, remove the ForeRunner from service and contact Customer Service.

Remove and reinstall the battery to perform a BIT. If the BIT passes, the FORERUNNER is ready for use. If the BIT fails, install a new battery and repeat the BIT. If the BIT passes, the ForeRunner is ready for use. If the BIT fails, remove the FORERUNNER from service and contact Customer Service.

User’s Guide 11

C HAPTER TWO

Putting the FORERUNNER into Service

12 FORERUNNER

C HAPTER T HREE

Using the FORERUNNER

his chapter describes how to use the FORERUNNER in an emergency. The F

to guide the operator through a variety of device and patient conditions. The steps for using the F the semi-automatic mode are explained ﬁrst. Use of the optional manual override button (Model EM) is described later in this chapter. Finally, this chapter describes corrective actions in cases when warnings or errors occur.

provides appropriate voice and display prompts

ORERUNNER automatically

ORERUNNER in

Preparation

Analysis and Monitoring

Semi-automatic Delivery of Deﬁbrillation Shock

Manual Delivery of Deﬁbrillation Shock

Error Conditions, Possible Causes, and Corrective Actions

Continued Use

User’s Guide 13

User’s Guide

C HAPTER T HREE

•

Using the FORERUNNER

PREPARATION

•

Press the On/Off button to turn on the FORERUNNER. Fol- low the instructions provided by the FORERUNNER voice and screen prompts.

Remove clothing from the patient’s chest. If necessary, wipe moisture from the patient’s chest and clip or shave excessive chest hair.

Open the package containing the deﬁbrillation pads with attached cable and connector. Pull off the protective backing from the deﬁbrillation pads. Ensure the pads are free from obvious signs of damage and that the gel has not dried out. If the pads are damaged or the gel has dried out, use a new set of pads.

Deﬁbrillation pad placement is essential to successful deﬁbrillation. Place one deﬁbrillation pad just below the patient’s right clavicle. Place the second deﬁbrillation pad over the ribs on the patient’s side in line with the axilla (armpit), and below the patient’s left breast. Refer to the diagram on the back of the deﬁbrillation pads.

Insert the deﬁbrillation pads connector in the connector socket located by the ﬂashing light.

•

14 FORERUNNER

FORERUNNER

C HAPTER T HREE

Using the FORERUNNER

WARNING: Use only Heartstream disposable deﬁbrillation pads, batteries,

and other accessories supplied by Heartstream or its authorized distributors. Substitution of non-Heartstream accessories may cause the device to perform improperly.

CAUTION: Follow all deﬁbrillation pad labeling instructions. Use deﬁbrillation pads prior to expiration date. Discard deﬁbrillation pads after use. Do not reuse deﬁbrillation pads.

WARNING: Do not place deﬁbrillation pads in the anterior-posterior position. A shock or no shock decision may be inappropriately advised. The F requires that the deﬁbrillation pads be placed in the anterior-anterior position.

WARNING: Do not allow deﬁbrillation pads to touch each other, or to touch 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 hear t.

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.

ORERUNNER

DANGER: Possible explosion hazard if used in the presence of ﬂammable anesthetics or concentrated oxygen.

DANGER: The FORERUNNER has not been evaluated or approved for use in haz- ardous locations as deﬁned in the National Electrical Code standard (Ar ticles 500-

503). In compliance with the IEC classiﬁcation (section 5.5) the F to be used in the presence of ﬂammable substance/air mixtures.

WARNING:

described in the User’s Guide. The FORERUNNER delivers electrical energy that can potentially cause death or injury if it is used or discharged improperly. Do not discharge with deﬁbrillation pads together or open and exposed.

CAUTION: Hazardous electrical output. This equipment is for use only by qualiﬁed personnel.

CAUTION: Aggressive or prolonged CPR to a patient with deﬁbrillation pads attached can cause damage to the pads. Replace the deﬁbrillation pads if they become damaged during use.

WARNING: Use of damaged equipment or accessories may cause the device to perform improperly and/or patient or user injur y.

Improper use can cause injury. Use the FORERUNNER only as

ORERUNNER is not

User’s Guide 15

C HAPTER T HREE

Using the FORERUNNER

ANALYSIS AND MONITORING

Follow the instructions provided by the FORERUNNER voice and

screen prompts.

•

When the FORERUNNER is turned on and detects that the deﬁbrillation pads are connected properly, it automatically begins analyzing ECG data to determine if a deﬁbrillation shock is appropriate therapy. If there is ECG interference, the FORERUNNER provides voice and screen prompts that advise you to take action, such as "DO NOT TOUCH THE PATIENT", until the ECG interference stops.

WARNING: Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis. Following “Shock Advised” prompts, patient movement and vibration, if present, must be minimized for at least 15 seconds to allow reconﬁrmation of ECG analysis before delivering a shock.

WARNING: In patients with cardiac pacemakers, the FORERUNNER may have reduced sensitivity and not detect all shockable rhythms.

WARNING: Radio frequency (RF) interference from RF devices such as cellular phones and two-way radios may cause improper FORERUNNER operation. In accordance with IEC standard 801.3, a distance of 2 meters (6 feet) between RF devices and the F recommended.

American Heart Association guidelines of 100 BPM (beats per minute) can cause incorrect or delayed diagnosis.

ORERUNNER is

WARNING: CPR rates above the

If No Shock is Advised

Voice and screen prompts inform you when the FORERUNNER determines that no shock is advised. The FORERUNNER continues to monitor ECG data while you provide appropriate care to the patient. While the FORERUNNER is monitoring the patient, voice prompts are suppressed.

While monitoring, if the FORERUNNER detects that the patient’s ECG changes to a potentially shockable rhythm or if the FORERUNNER is not able to analyze the rhythm because of interference, it will automatically shift to analyzing mode and give corresponding voice and screen prompts to advise you to respond appropriately.

If No Shock is Advised and the No Shock Advised (NSA)

Pause for CPR is Programmed

Voice and screen prompts inform you when the FORERUNNER determines that no shock is advised. The FORERUNNER then pauses to allow time to administer CPR, if needed, without interruption. See Pause for CPR later in this chapter for more details.

At the end of the pause for CPR, the FORERUNNER returns to monitoring the patient as described above.

16 FORERUNNER

C HAPTER T HREE

Using the FORERUNNER

SEMI-AUTOMATIC DELIVERY OF DEFIBRILLATION SHOCK

Press the shock button to deliver the shock.

The FORERUNNER requires ﬁve seconds of interference free ECG data to determine if a shock is appropriate therapy.

WARNING: Deﬁbrillation current can cause operator or bystander injury. Do not touch the patient during deﬁbrillation. Do not touch equipment connected to or metal objects in contact with the patient during deﬁbrillation. Disconnect other electrical equipment from the patient before deﬁbrillating. Disconnect the FORERUNNER from the patient prior to use of other deﬁbrillators.

When the FORERUNNER has analyzed the ECG data and determined that a deﬁbrillating shock is appropriate, audible warnings and screen prompts tell you that a shock is advised and to stand clear of the patient. While the FORERUNNER charges, it continues to monitor ECG data.

In the event a patient’s heart rhythm spontaneously returns to one for which shock is not advised, the FORERUNNER disarms. Voice and display prompts advise you what action to take.

Note that when the FORERUNNER is fully charged, you can disarm it at any time by pressing the On/Off button to turn off the FORERUNNER.

The FORERUNNER provides four ways of prompting a shock. Press the shock button when any of these occur:

• a voice prompt instructs you to deliver a shock

• the shock button ﬂashes

• you hear a steady tone

• you see a screen prompt

The FORERUNNER will not automatically deliver a shock.

•

User’s Guide 17

PAUSE FOR CPR

PAUSED

1:06 3

ATTEND TO PATIENT

C HAPTER T HREE

Using the FORERUNNER

After you press the shock button , a voice prompt conﬁrms that the shock was delivered and the FORERUNNER automatically resumes analyzing the ECG data to determine if the shock was effective. The FORERUNNER continues to provide voice and display prompts that guide you through additional shock sequences, if appropriate. The FORERUNNER also displays the number of shocks that have been delivered. If a series of unsuccessful shocks has occurred, the FORERUNNER will automatically pause for CPR (see Pause for CPR, CS Pause for CPR below).

The FORERUNNER automatically pauses to allow time to administer CPR with associated verbal and screen prompts at the beginning of the pause period. The FORERUNNER suppresses analysis and voice prompts during the pause to allow uninterrupted patient care. The heart rate display also is blank during the pause period.

During a pause for CPR, the screen displays a bar that ﬁlls as the pause time elapses.

A Bar indicates time remaining in the pause for CPR B Elapsed time since the FORERUNNER was turned on and the

number of shocks delivered The FORERUNNER can be programmed with a setup card (see

Appendix A for instructions) to provide two independent pause periods, a Consecutive Shock (CS) pause and a NO Shock Advised (NSA) pause.

CS Pause The FORERUNNER can be set up to pause after a series of con-

secutive unsuccessful shocks. Typically, protocols advise up to three consecutive shocks, followed by a one minute pause for CPR. The FORERUNNER can be programmed, however, to change both the number of consecutive shocks before a pause and the duration of the CS pause period (see Appendix A for instructions).

NSA Pause

A pause for CPR following a No Shock Advised prompt is also available. As with the CS pause, the duration of the NSA pause is programmable.

18 FORERUNNER

PAUSED

1:06 3

RESUME ANALYZING

C HAPTER T HREE

Using the FORERUNNER

Resume Analysis During Pause

All FORERUNNER models include an option that lets you quit the pause for CPR to manually resume ECG analysis. You can implement this option when you set up the FORERUNNER. See Appendix A for setup instructions. If this option is implemented, the screen includes a text prompt opposite a contrast button during a pause for CPR. To quit the pause for CPR and

resume ECG analysis, press the contrast down button .

If you use the MODEL E or MODEL EM, you can see the patient’s ECG trace on the screen.

At the end of the pause for CPR or when you resume analysis, the FORERUNNER advises you to stop moving the patient so it can perform analysis on the ECG data without interference. Voice and screen prompts guide you through additional shock sequences, if appropriate.

MANUAL DELIVERY OF DEFIBRILLATION SHOCK

The FORERUNNER Model EM includes a manual override button to allow qualiﬁed personnel the option to deliver a shock regardless of the FORERUNNER’s analysis of ECG data.

You can use manual override after connecting the deﬁbrillation pads. The manual override button does not function if:

• the FORERUNNER Model EM analysis already indicates a

CAUTION: The FORERUNNER manual override button is intended for use only by qualiﬁed operators who have been trained in rhythm recognition and treatment through manual charging and deliver y of deﬁbrillation shocks.

shock is appropriate.

• deﬁbrillation pads are not attached.

User’s Guide 19

C HAPTER T HREE

Using the FORERUNNER

CAUTION: The LCD screen is intended only for basic ECG rhythm identiﬁcation. The frequency response of the monitor screen is not intended to provide the resolution required for diagnostic and ST segment interpretation.

DISARM

To use the manual override button:

1. Slide the cover away from the manual override button.

2. Press the manual override button once to select the manual override mode.

3. Press manual override again within ﬁve seconds to charge the FORERUNNER Model EM so you can deliver a shock. The FORERUNNER is ready to deliver a shock when the shock button illuminates and ﬂashes, and you hear a steady tone.

4. Press the shock button to deliver a shock.

If you fail to press the manual override button a second time within 5 seconds, the FORERUNNER returns to semiautomatic operation; it analyzes the patient’s heart rhythm and illuminates the shock button if analysis determines that a shock is appropriate.

If you decide against delivering the shock after the FORERUNNER Model EM is charged, press the manual override button to disarm and return to semi-automatic operation. The FORERUNNER automatically disarms and returns to semi-automatic operation after 30 seconds if the shock button

has not been pressed.

MANUAL OVERRIDE

20 FORERUNNER

C HAPTER T HREE

Using the FORERUNNER

ERROR CONDITIONS, POSSIBLE CAUSES, AND CORRECTIVE ACTIONS

If the FORERUNNER detects an error condition or system fault during use

, it provides a voice or display prompt, or a

combination of both. These are described below.

Error Condition Possible Cause Corrective Action

A screen prompt alerts you that the FORERUNNER is not

ready for use or that a self test failed. The Status Indicator dis-

plays a ﬂashing or solid red X.

A screen prompt alerts you to a low battery condition.

A screen prompt instructs you to replace the battery immediately. The Status Indicator displays a ﬂashing red X.

The FORERUNNER performs self tests when you turn it on and while it is in use. A test revealed a failure or error.

The FORERUNNER battery is low. Battery failure may be imminent.

No power remains to continue operating the FORERUNNER. If you do not replace the battery, the FORERUNNER turns off.

Unplug the pads connector from the FORERUNNER. Remove and reinstall the battery to perform a BIT. If the BIT passes, the FORERUNNER is ready for use. If the BIT fails, install a new battery and repeat the BIT. If the BIT passes, the FORERUNNER is ready for use. If the BIT fails, remove the FORERUNNER from service and contact Customer Service.

NOTE: You can stop the BIT and resume use of the FORERUNNER as soon as the status indicator changes to the alternating hourglass.

Replace the battery as soon as possible.

Replace the battery immediately.

NOTE: Perform CPR (as necessary) any time there is a delay in FORERUNNER use.

User’s Guide 21

C HAPTER T HREE

Using the FORERUNNER

Error Condition Possible Cause Corrective Action

Voice and screen prompts instruct you to attach the

deﬁbrillation pads and to plug in the connector.

Voice and screen prompts instruct you to check the

deﬁbrillation pads or to press the deﬁbrillation pads ﬁrmly to the

patient’s chest.

The deﬁbrillation pads:

• are not properly applied to

the patient.

• are not connected to the

FORERUNNER.

• are touching each other.

The deﬁbrillation pads are not making proper contact with the patient’s bare chest.

• Ensure that the deﬁbrilla-

tion pads connector is completely inserted in the connector socket.

• Check the deﬁbrillation

pads on the patient and ensure that the pads adhere completely to the skin.

• If necessary, wipe moisture

from the patient’s chest and shave or clip excessive chest hair.

• Replace the deﬁbrillation

pads if the prompt continues.

• Check the deﬁbrillation

pads on the patient and ensure that the pads adhere completely to the skin.

• If necessary, wipe moisture

from the patient’s chest and shave or clip excessive chest hair.

• Replace the deﬁbrillation

pads if the prompt continues.

Voice and screen prompts instruct you to replace the

deﬁbrillation pads.

• The deﬁbrillation pads,

cable, or connector may be damaged.

Replace the deﬁbrillation pads.

• The FORERUNNER has

detected a possible short in the deﬁbrillation pads or cable.

22 FORERUNNER

C HAPTER T HREE

Using the FORERUNNER

Error Condition Possible Cause Corrective Action

Voice and screen prompts alert you that the ECG analysis has

been interrupted.

Voice and screen prompts alert you that a

ered when you pressed the

shock button .

shock was not deliv-

• Patient motion

• Radio or electrical sources

• Motion around the patient

in a dry environment where signiﬁcant static electricity is present

The FORERUNNER will not deliver a shock within speciﬁcations if the patient impedance is out of the speciﬁed range.

• Discontinue CPR; do not

touch the patient. Attempt to eliminate patient motion, if possible.

• Stop the patient transport

vehicle if needed.

• Check for and remove pos-

sible causes of radio and electrical interference.

• Check the deﬁbrillation

pads for proper placement.

• Check the deﬁbrillation

pads connector.

• Press the deﬁbrillation pads

ﬁrmly to the patient’s chest.

• Replace the deﬁbrillation

pads if necessary.

User’s Guide 23

C HAPTER T HREE

Using the FORERUNNER

CONTINUED USE

The FORERUNNER provides a feature called Continued Use to preserve the data recorded during an emergency event when you change a battery or turn the F off brieﬂy. If the F

ORERUNNER is turned off and then

ORERUNNER

on again during an emergency event, data on the card and in Summary Event Review is preserved and new data appended if:

1. The F

ORERUNNER is turned off for less than 5

minutes, or

2. The battery is removed for less than 30 seconds. Data preservation is not assured if the battery is removed for more than 30 seconds.

Continued Use also allows you to quickly resume patient care when changing a battery during use. When a Continued Use occurs, the Battery Insertion Test is not done unless the status indicator shows the device is not ready for use. Then the test is run to attempt to clear any error conditions.

24 FORERUNNER

C HAPTER FOUR

Maintaining

Self Tests and

ORERUNNER Maintenance

Maintenance Schedule

Cleaning

Automated Deﬁbrillators:

Operator’s Check List

the F

ORERUNNER

his chapter describes FORERUNNER automatic self tests and the occasional maintenance that you

ELF TESTS AND FORERUNNER MAINTENANCE

perform to assure that it is always ready for use.

The FORERUNNER automatically performs periodic self tests when a battery is installed and has enough power to perform the tests. The F

ORERUNNER displays a message

during these tests indicating that a self test is running.

•

If you press On/Off

during a self test, you discontinue

the test. The test is automatically rescheduled.

The results of the automatic self tests are displayed on the Status Indicator.

User’s Guide 25

User’s Guide

C HAPTER FOUR

Maintaining the FORERUNNER

The Status Indicator displays information about self test results:

Alternates these shapes if the

ORERUNNER passed the last self test.

Flashing red X accompanied by a chirping sound indicates a self test error occurred or that the battery is low or depleted.

Solid red X indicates the batter y is completely depleted or a self test failure occurred.

If the FORERUNNER passed its last automatic self test, the Status Indicator alternates

between dark square and

hourglass shapes.

A self test error, storage of the F

ORERUNNER outside of the

recommended temperature range, or a low or partially depleted battery results in a ﬂashing X displayed on the Status Indicator accompanied by a chirping sound. A solid X is displayed if a Training or Setup Card is installed, the battery is missing or fully depleted, or a self test failure occurs.

If the Status Indicator displays anything other than the alternating hourglass shapes, such as a constant dark shape or a ﬂashing or solid X, remove the F

ORERUNNER from

service. If there is no "low battery" or "replace battery" screen message, remove and reinstall the existing battery and perform the BIT as described in Chapter 2, Putting the

ORERUNNER into Service. If the BIT passes and the Status

Indicator alternates dark and hourglass shapes, return the F

ORERUNNER to service. If the BIT fails, install a new

battery and repeat the BIT a second time. If the BIT passes, return the F the F

ORERUNNER from service and contact Customer

ORERUNNER to service. If the BIT fails, remove

Service.

The F

ORERUNNER is designed to be transported, stored, and

operated within the environmental conditions speciﬁed in Appendix B. F

ORERUNNER performance may be decreased

outside of these conditions.

Self Tests During Use

The FORERUNNER performs a Power On Self Test (POST) each time you turn it on. Self tests continue to monitor the hardware and software systems and battery while the F

ORERUNNER is in use.

26 FORERUNNER

FORERUNNER

C HAPTER FOUR

Maintaining the FORERUNNER

MAINTENANCE SCHEDULE

The following table provides suggested frequencies for maintenance. Different frequency intervals may be appropriate depending upon the environment in which the FORERUNNER is used, and is at the discretion of your program's medical director.

Frequency Observe Take Action

Daily, and after each use

Check the Status Indicator. Verify that you see alternating dark and hourglass shapes that indicate the

ORERUNNER is ready to use.

Ensure that all supplies, accessories, and spares are present, undamaged, and have not passed their expiration dates.

If you see any condition other than the alternating dark square and hourglass shapes such as a constant dark shape, a ﬂashing red X or a solid red

X, do the following. If there is

no "low battery" or "replace battery" screen message, remove and reinstall the existing battery and perform the BIT as described in Chapter 2,

Putting the FORERUNNER into Service. If the BIT passes and

the Status Indicator alternates dark and hourglass shapes, return the FORERUNNER to service. If the BIT fails, install a new battery and repeat the BIT a second time. If the BIT passes, return the FORERUNNER to service. If the BIT fails, remove the FORERUNNER from service and contact Customer Service.

Do not use damaged or expired supplies, accessories, or spares. Replace supplies, accessories, and spares as needed.

Do not leave electrodes connected to the FORERUNNER when not in use.

User’s Guide 27

C HAPTER FOUR

Maintaining the FORERUNNER

Frequency Observe Take Action

Weekly and after each use

After each use

Ensure the exterior of the FORERUNNER and the connector socket are free of cracks and signs of damage.

Perform a BIT if the FORERUNNER is damaged or subjected to abuse. If cracks or damage are noted, remove the FORERUNNER from service and contact Heartstream Customer Service.

PC data card

Remove the used PC data card and replace it with a spare according to instructions found in Chapter 5, Event Review Storage and Retrieval.

Apply the patient ID label to the PC data card and deliver the card to appropriate personnel according to local guidelines and medical protocol.

Ensure the FORERUNNER exterior and connector socket are free of dirt or contamination

Status Indicator

Calibration is unnecessary as the F tests and correct operation is veriﬁed during the BIT. The FORERUNNER does not require manual veriﬁcation of energy deliver y because monthly automatic self tests verify the waveform deliver y system.

The FORERUNNER has no user serviceable parts and Hear tstream is the sole repair facility for the unit. As a result, we do not publish Service/Maintenance and Repair Manuals for technical professionals.

CAUTION: Improper maintenance can cause the FORERUNNER not to function. Maintain the ForeRunner only as described in this User’s Guide or as designated by your program’s medical director.

CAUTION: Electrical shock hazard. Dangerous high voltages and currents are present. Do not open unit, remove covers, or attempt repair. There are no user serviceable components in the FORERUNNER. Refer ser vicing to qualiﬁed service personnel.

Clean the FORERUNNER, if needed. See the section later in this chapter titled Cleaning.

Perform the BIT according to instructions in Chapter 2.

ORERUNNER automatically performs daily self

28 FORERUNNER

CLEANING

C HAPTER FOUR

Maintaining the FORERUNNER

To clean the FORERUNNER, observe the following guidelines:

• The FORERUNNER should only be cleaned with the battery in place to keep ﬂuids out of the PC data card slot and battery contact area.

• Use a soft cloth. Do not use abrasive materials, cleaners, or strong solvents such as acetone, or acetone based cleaners.

• Do not immerse the F

• Clean the F

ORERUNNER and the connector socket

ORERUNNER in ﬂuids.

with appropriate cleaning agents listed below. The connector socket includes a slot (

A) to allow thorough

cleaning.

Use only the following cleaning agents:

• 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 FORERUNNER in water or other ﬂuids. Do not allow ﬂuids to enter the FORERUNNER. Avoid spilling any ﬂuids on the FORERUNNER or accessories. Spilling ﬂuids into the FORERUNNER may damage it or present a ﬁre or shock hazard. Do not autoclave or gas sterilize the FORERUNNER or accessories.

•

User’s Guide 29

C HAPTER FOUR

Maintaining the FORERUNNER

The following checklist is provided for your reference.

UTOMATED DEFIBRILLATORS: OPERATOR’S CHECK LIST

FORERUNNER Model No.: __________ Serial No.: __________________________________

FORERUNNER Location or vehicle ID:____________________________________________

Inspect the FORERUNNER at frequencies speciﬁed in this chapter or as designated by your medical director. Indicate whether all requirements have been met. Note any corrective action taken. Sign at the bottom of the form.

Date

Frequency Interval

ORERUNNER Unit

Clean, no dirt or contamination; no damage present

Supplies Available:

a. Two sets deﬁbrillation pads,

sealed, within expiration date, undamaged

b. Ancillary supplies (Hand

towel, scissors, razor)

c. Spare unopened batter y

within “Install Before” date

d. PC data card undamaged,

with spares*

Status Indicator

a. Self test okay, verify by noting

Status Indicator

Inspected by:

Remarks, Problems, Corrective Actions

* Applicable only if unit uses this option.

30 FORERUNNER

C HAPTER FIVE

Event Review Storage and Retrieval

he FORERUNNER stores data in its own internal memory and on optional PC data cards supplied

internal memory and the PC data card can be displayed on the F CodeRunner® software to review, archive, and report the information stored on the PC data cards.

by Heartstream. Data stored in the F

ORERUNNER screen. Heartstream also provides

ORERUNNER

NSTALLING THE OPTIONAL PC DATA CARD

Installing the Optional PC Data Card

Event Review

User’s Guide 31

User’s Guide

If you use the optional PC data card, the FORERUNNER can store and retrieve more detailed information about its own status and about emergency events.

If you choose to use a PC data card, it must be installed before you put the F

ORERUNNER into service.

C HAPTER FIVE

Event Review Storage and Retrieval

Use only Heartstream PC data cards. Other data cards are not compatible with the F

ORERUNNER.

To install the optional PC data card:

•

PULL TAB

1. Remove the battery.

2. Make sure the card is clean, dry, and free of old patient identiﬁcation labels.

3. Insert the PC data card in the slot with the arrow label facing up.

4. Push the card in until it is ﬂush with the slot. Do not force the card into the slot. If the card is hard to insert, remove it and verify that the arrow label faces up.

5. Replace the battery and perform the BIT.

32 FORERUNNER

FORERUNNER

C HAPTER FIVE

Event Review Storage and Retrieval

After each FORERUNNER use, replace the PC data card:

1. Remove the battery.

2. Pull the PC data card out by its pull tab.

3. Apply the patient ID label to the PC data card and deliver the card to the appropriate personnel.

4. Insert a new PC data card.

5. Replace the battery and perform the BIT.

VENT REVIEW

The FORERUNNER automatically stores information about a use of the F

ORERUNNER in an emergency event even if a PC

data card is not used. This information can be displayed on the F

ORERUNNER screen.

How to Display Event Review

You can display a Summary or Full Event Review at any time unless:

•a F

User’s Guide 33

ORERUNNER Training card is installed ORERUNNER Setup card is installed

C HAPTER FIVE

Event Review Storage and Retrieval

To display the Event Review:

1. Turn off the FORERUNNER.

2. Press both contrast buttons while you press the On/Off button on the F

•

ORERUNNER.

34 FORERUNNER

C HAPTER FIVE

Event Review Storage and Retrieval

Summary Event Review

If a PC data card was not installed during the last emergency event, you can view Summary information on the F

ORERUNNER screen. Summary Event Review includes:

• the elapsed time that the FORERUNNER was on during the emergency event

• the number of shocks delivered

You can display a Summary Event Review for the last emergency event until it is overwritten by the next new use of the F

Full Event Review

ORERUNNER in an emergency event.

PC data card options add information storage and retrieval capabilities to the Event Review. See Appendix B for information about PC data card capabilities. If a PC data card is installed, the F

ORERUNNER automatically stores Full

Event Review information on the card. Full Event Review information includes:

• the elapsed time that the F

ORERUNNER was on

during the emergency event

• the number of shocks delivered

• the times of the ﬁrst shocks delivered

•F

ORERUNNER related events and associated times

EVENT REVIEW

PRESS OFF TO QUIT ELAPSED TIME 4:08 SHOCKS DELIVERED: 4 FIRST SHOCKS AT:

00:26 01:35 03:02

NEXT SCREEN

User’s Guide 35

C HAPTER FIVE

Event Review Storage and Retrieval

Full Event Review appears on several screens in a sequence. The highlight bar appears on the lower line. Press the contrast down button to display the next screen.

The data stored on the PC data card is overwritten by the next new use of the F

ORERUNNER in an emergency event.

The data can be erased from the card by using the optional accessory software.

36 FORERUNNER

A PPENDIX A

FORERUNNER Options

ORERUNNER models, setup options, and PC data

card models let you customize the F

The three available models are the FORERUNNER Model S, F

match your program’s protocol. This Appendix describes F

ORERUNNER MODELS

ORERUNNER Model E, and FORERUNNER Model EM.

ORERUNNER options.

ORERUNNER to

The FORERUNNER Model S is the standard model. The F

ORERUNNER Models

Using the FORERUNNER Setup Card

Conﬁguring Setup Options

Training Options

User’s Guide 37

User’s Guide

ORERUNNER Model S does not display an ECG trace or

heart rate.

The F

ORERUNNER Model E (enhanced) adds the option to

display heart rate and an ECG trace. You select the display options using the F the F

ORERUNNER into service.

The FORERUNNER Model EM (enhanced manual) always displays heart rate and an ECG trace, and has the manual override button.

ORERUNNER Setup card before you put

A PPENDIX A

FORERUNNER Options

USING THE FORERUNNER SETUP CARD

Before you put a FORERUNNER into service, you should conﬁgure options to match your program’s protocol using the F

ORERUNNER Setup card. Failure to conﬁgure settings

correctly may adversely affect use of the F

ORERUNNER.

To conﬁgure options, install the FORERUNNER Setup card:

•

1. Remove the battery.

2. Insert the Setup card in the slot with the arrow label facing up.

3. Push the card in until it is ﬂush with the slot. Do not force the card into the slot. If the card is difﬁcult to insert, remove it and verify that the arrow label faces up.

4. Replace the battery.

When you install the Setup card, the F

ORERUNNER

automatically turns on with the setup options displayed on the screen. No BIT takes place.

38 FORERUNNER

FORERUNNER

A PPENDIX A

FORERUNNER Options

While the Setup card is installed:

•

• the On/Off button is disabled

• the F

ORERUNNER is operable only for setup functions

• the Status Indicator shows a solid red X

• if no buttons are pressed for ﬁve minutes, the F

ORERUNNER “chirps” to prompt you to continue

the setup or remove the Setup card

At the completion of the setup, remove the Setup card, replace the battery, and perform the BIT to put the F

ORERUNNER into service.

ONFIGURING SETUP OPTIONS

Setup options are described below. Press the contrast down button to move between menu items. Press the contrast up button to choose or change an option. Setup options are saved automatically in the F

ORERUNNER when you quit

setup.

User’s Guide 39

A PPENDIX A

FORERUNNER Options

General Setup Options

Menu item Options Factory Settings

Prompts

Speaker Volume

ECG Record

ECG Displayed (Model E only)

Go to CPR Protocol

Short or Long. Long voice prompts contain more descriptive information. Short voice prompts are intended for use by more experienced responders.

1-8. Eight possible settings. 8 is full volume.

Std or Low. Std records ECG data on PC data cards at 200 data samples per second; low at 100 samples per second. Low resolution recording provides a longer ECG recording. Std resolution provides research quality ECG recording.

Ye s or no. ECG is displayed on the screen.

Displays options to customize the CPR and Shock sequence.

Long

Std

Yes. ECG display on. (ECG is always displayed on Model EM.)

See CPR Protocol Setup Options that follow.

Go to Device History

Displays Device History. See Device History information

that follows.

40 FORERUNNER

A PPENDIX A

FORERUNNER Options

CPR Protocol Setup Options

Menu item Options Factory Settings

Shocks

Consecutive Shock (CS) CPR Timeout

No Shock Advised (NSA) CPR Timeout

1, 2, or 3. Number of shocks delivered in a sequence before the FORERUNNER will pause for CPR.

0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, or ∞. CS CPR Timeout is the interval in minutes provided for CPR after each Shock sequence. The F

ORERUNNER

automatically pauses for CPR after the setup number of consecutive shocks. It resumes analyzing automatically at the end of the CPR Timeout or when the Resume Analyzing button is pressed by the user. If CPR Timeout is set to ∞, the automatic resume analyzing is disabled, and the user MUST press the Resume Analyzing button to quit the pause for CPR.

0, .25, 0.5, 1.0, 1.5, 2.0, 3.0, and ∞. NSA CPR Timeout is the interval in minutes provided for CPR immediately after a No Shock Advised condition. See CS CPR Timeout for Resume Analyzing details.

3 shocks

1.0 minute

0 minutes

User’s Guide 41

A PPENDIX A

FORERUNNER Options

Resume Analysis

ON or OFF. ON activates a Resume Analyzing button to allow you to manually quit the pause for CPR and resume ECG analysis. OFF inhibits activation of the Resume Analyzing button. NOTE: ON is the only choice available if you select a CPR Timeout greater than 60 seconds.

OFF (ON if CPR Timeout is greater than 60 seconds)

42 FORERUNNER

A PPENDIX A

FORERUNNER Options

FORERUNNER Device History

Information about the FORERUNNER automatically accumulates in its internal memory throughout the F

ORERUNNER’s lifetime. When you select the Device History

option on the Setup card, a screen displays the following information.

Device History Display

Screen Display Options

USES:

SHOCKS:

TRAINING:

TESTS:

The ﬁrst number is the cumulative number of new uses during the FORERUNNER lifetime. The cumulative time (in minutes) of all FORERUNNER uses in which deﬁbrillation pads were connected to the patient during emergency events is indicated by the second number.

Cumulative number of shocks delivered by the FORERUNNER in its lifetime.

The ﬁrst number is the cumulative number of times the Training card was inserted and used during the FORERUNNER’s lifetime. The cumulative training time (in minutes) is indicated by the second number.

Cumulative number of tests that have been performed during the FORERUNNER’s lifetime.

A: Number of daily automatic self tests B: Number of weekly automatic self tests C: Number of monthly automatic self tests D: Number of Battery Insertion tests

User’s Guide 43

A PPENDIX A

FORERUNNER Options

TRAINING OPTIONS

Heartstream offers an optional FORERUNNER Training card and user’s guide. The F

ORERUNNER Training card includes

simulated scripts that guide responders through several emergency events.

A training card must always be installed in the F

ORERUNNER

when using it for training or demonstration purposes. When the training or demonstrations are complete, remove the training card to return the F

ORERUNNER to service and

prevent battery depletion.

44 FORERUNNER

A PPENDIX B

Speciﬁcations

his appendix presents technical speciﬁcations, waveform speciﬁcations, a clinical summary, and

information about service and replaceable parts.

Technical Speciﬁcations

Heartstream Clinical Summary and American Heart Association Deﬁbrillation Statement

Service and Replaceable Parts

User’s Guide 45

User’s Guide

A PPENDIX B

Specifications

TECHNICAL SPECIFICATIONS

Physical

Category Speciﬁcation

Size

2.53 inches high x 8.75 inches wide x 8.0 inches deep (64 mm x 223 mm x 203 mm)

Weight

Approximately 2 kg (4.4 lbs) with battery installed.

Environmental

Category Speciﬁcation

Operating Temperature/ Humidity

Standby Temperature/Humidity

0 to 50˚C (32 to 122˚F), 0% to 95% Relative Humidity (noncondensing).

10 to 43˚C (50 to 109˚F), 0% to 75% Relative Humidity (noncondensing). FORERUNNER with battery installed, stored with deﬁbrillation pads.

Altitude

Shock/Drop Abuse Tolerance

-500 to 15,000 feet per MIL-810E 500.3 Procedure II.

MIL-STD-810E 516.4 Procedure IV (1 meter, any edge, corner, or surface).

Vibration

Sealing

ESD

MIL-STD-810E 514.4-17.

IEC 529 class IP54; Splash Proof, Dust Protected.

IEC 801-2 Severity Level 4.

EMI (Radiated)

EMI (Immunity)

Transportation Environment

CISPR11 Group 1 Level B.

IEC 801-3 Level 2.

RTCA/DO-16OC “Environmental conditions and test procedures for airborne equipment”.

46 FORERUNNER

FORERUNNER

A PPENDIX B

Specifications

Deﬁbrillator

Category Speciﬁcation

Waveform

Energy/Energy Selection

Charge Control

Charge Time from Shock Advised

Shock-to-Shock Cycle Time

Charge Complete Indication

Shock Discharge Control

Disarm–Semi-Automatic Operation

Truncated Exponential Biphasic. Waveform parameters are adjusted as a function of patient deﬁbrillation impedance.

Single Energy—a nominal of 150 Joules (minimum of 130 Joules) delivered to a 50 ohm load.

Under control of the Patient Analysis System for semi-automatic operation. The manual override button allows manual charge control (FORERUNNER Model EM only).

Typically less than 10 seconds. Charge time increases at the end of battery life as well as at temperatures below 10°C.

Typically less than 20 seconds (including analysis time) in semiautomatic mode.

FORERUNNER is ‘armed’ when shock button is ﬂashing and armed tone is activated.

Shock is delivered by a single shock button.

Once the FORERUNNER is charged, it will disarm under any of the following conditions:

• a no shock decision is reached

• the FORERUNNER On/Off button is pressed and the

FORERUNNER is turned off

• the deﬁbrillation pads are removed from the patient or the

pads connector is disconnected from the FORERUNNER

Disarm–Manual Operation

Once the FORERUNNER is charged, it will disarm under any of the following conditions:

• 30 seconds after charging if a shock is not delivered

• manually by pressing the manual override button

• the FORERUNNER On/Off button is pressed and the

FORERUNNER is turned off

• the deﬁbrillator pads are removed from the patient or the

pads connector is disconnected from the FORERUNNER

User’s Guide 47

A PPENDIX B

Specifications

Category Speciﬁcation

Shock Delivery

Via deﬁbrillation pads placed in the anterior-anterior (Lead II) position.

Patient Analysis System

Category Speciﬁcation

Patient Analysis

Evaluates deﬁbrillation pads’ impedance for proper deﬁbrillation pad contact, and evaluates patient ECG and signal quality to determine if a shock is appropriate.

Protocols

Follows pre-conﬁgured settings to match your program’s protocols. These settings can be modiﬁed using the setup options.

Shockable Rhythms

VF and certain VT rhythms (including ventricular ﬂutter and polymorphic VT).

WARNING: Some ver y low amplitude or low frequency rhythms may not be

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

48 FORERUNNER

Patient Analysis System Performance

A PPENDIX B

Specifications

Rhythm Class ECG Test

Sample1 Size

Shockable Rhythm - VF

Shockable Rhythm - VT

Non-shockable rhythm - Normal sinus rhythms

Non-shockable rhythm - Asystole

Non-shockable rhythm - all other non-shockable rhythms

From Heartstream ECG rhythm databases.

Automatic External Deﬁbrillators for Public Access Use: Recommendations for Specifying and Repor ting Arrhythmia Analysis Algorithm Performance, Incorporation New Waveforms, and Enhancing Safety, American Heart Association (AHA) AED Task Force, Subcommittee on Safety & Efﬁcacy, draft 3/18/96, Table 2.

300 FORERUNNER meets the AAMI DF39

100 FORERUNNER meets the AAMI DF39

300 FORERUNNER meets the AAMI DF39

100 FORERUNNER meets the AAMI DF39

450 FORERUNNER meets the AAMI DF39

Speciﬁcation

requirement and AHA recommendation2 of Sensitivity>90%

requirement and AHA recommendation

of Sensitivity>75%

requirement of Speciﬁcity>95% and AHA recommendation2 of Speciﬁcity>99%

requirement and AHA recommendation2 of Speciﬁcity>95%

User’s Guide 49

A PPENDIX B

Specifications

ECG Display (Available only on Model E and Model EM)

Category Speciﬁcation

Monitored Lead

ECG information is acquired through deﬁbrillation pads in anterior-anterior (Lead II) placement.

Display Range

Screen

Screen Dimensions

Sweep Speed

Frequency Response (Bandwidth)

Sensitivity

Heart Rate (Normal Sinus Rhythm)

Differential: ±2 mV full scale nominal.

High resolution LCD with backlight.

2.8 inches wide x 2.3 inches high (70 mm x 58 mm).

23 mm/sec. nominal.

Nondiagnostic rhythm monitor 1 Hz to 20 Hz (-3 dB) nominal.

1.16 cm/mV nominal.

Displays a range of 30 to 300 beats per minute updated each analysis period. Heart rate is displayed only during monitoring mode and if ECG is displayed.

Battery Pack

Category Speciﬁcation

Battery

18 VDC 1300 mAH lithium. Disposable, recyclable, long-life, primary cells.

Capacity

A new battery typically will provide 100 shocks or 5 hours of operating time, or 10 hours of training time at 25˚C.

Shelf-Life

Typically 5 years from date of manufacture when stored at standby environmental conditions in original, unopened packaging.

Standby Life

Typically more than one (1) year when stored under standby environmental conditions (1 battery insert test and no uses or training).

Low Battery Detection

Deﬁbrillator detects low battery condition during daily periodic self tests. Replace the battery when the Status Indicator shows a solid or ﬂashing red X.

50 FORERUNNER

A PPENDIX B

•

Specifications

Controls and Indicators

Category Speciﬁcation

Main LCD screen

Controls

LED Indicators

Audio Speaker

Beeper

Status Indicator

Deﬁbrillation Pads

A high resolution, backlit LCD screen displays ECG (MODELS E and EM) and informational/instructional text messages on all models.

On/Off button Shock button Manual override button (MODEL EM Only) Contrast up button Contrast down button

Connector socket LED illuminates and ﬂashes to indicate the socket location and is covered when the deﬁbrillation pad connector is properly inserted.

The shock button illuminates (ﬂashes) when the deﬁbrillator is armed.

An audio speaker provides voice prompts. Volume of voice prompts is adjustable using the Setup card.

The beeper chirps as an alert when a self test has failed (standby mode), and generates various warning tones during normal use.

A Status Indicator LCD displays the results of the last self test.

Category Speciﬁcation

Deﬁbrillation Pads, Cable, and Connector

Disposable and self adhesive. Deﬁbrillation 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, long cable and connector.

Deﬁbrillation Pad Requirements

Use only Heartstream deﬁbrillation pads with the FORERUNNER. Place the pads in standard anterior-anterior position.

User’s Guide 51

A PPENDIX B

Specifications

PC Data Cards, Training and Setup Cards (Options)

All FORERUNNER models come equipped with built in hardware and software that enable the deﬁbrillator to perform additional medical control, setup, and training functions when used with optional Heartstream Setup, Training, and PC data cards. The information stored on the data cards can be reviewed using optional software.

Category Speciﬁcation

Event Review Card

Full ECG Card

Voice and ECG Card

Training Card

Setup Card

Provides the FORERUNNER with Event Review capability and 15 minutes of ECG data collection. This card incorporates a real time clock which provides a means for synchronizing the EMS system time with the recorded code events.

Provides the FORERUNNER with Event Review capability as well as providing a maximum of 30 minutes of ECG data collection. A real time clock is also incorporated in this card.

Same as Full ECG Card with the added capability of digitally recording a maximum of 26 minutes per use near area sounds and voices. Sound recording is synchronized with ECG and event data.

When the Training card is installed, the FORERUNNER operates in a special training mode which provides several training scenarios. Use of the Training card and training scenarios are described in the Training card user’s guide.

Provides the system administrator with a means to tailor the FORERUNNER to your program’s protocol.

52 FORERUNNER

A PPENDIX B

Specifications

Waveform Speciﬁcations

The FORERUNNER deﬁbrillator delivers patient-compensated biphasic truncated exponential waveforms with a nominal of 150 Joules (minimum of 130 Joules) delivered to a 50 ohm load.

2000

peak

1500

1000

500

Voltage (V)

final

-500

-1000

-1 0 1 2 3 4 5 67 8910

Phase 1 Duration Phase 2 Duration

Interphase DelayBITE

Time (ms)

The “BITE” is the biphasic initiation and termination element, and is used to determine whether the load impedance is within an acceptable range. The F

ORERUNNER

deﬁbrillator delivers shocks to load impedances from 25 to 180 ohm. The duration of each phase of the waveform is dynamically adjusted based on delivered charge in order to compensate for patient variability as follows:

Load

Resistance

(Ω)

25 ± 1%

50 ± 1%

100 ± 1%

125 ± 1%

User’s Guide 53

Phase 1 Duration

(ms)

2.83 ± 5%

4.09 ± 5%

8.95 ± 5%

12.00 ± 5%

Phase 2 Duration

(ms)

2.83 ± 5%

4.09 ± 5%

5.97 ± 5%

8.00 ± 5%

Total

Tilt (%)

min max

88 90

78 81

75 78

77 81

Delivered

Energy

(J)

min max

130 182

130 178

131 176

132 178

A PPENDIX B

Specifications

Total tilt is deﬁned as the percent voltage decay from the peak voltage of the ﬁrst phase to the ﬁnal voltage of the second phase:

Total Tilt

----------------------------------------

peak

100× %=

–()

peakVfinal

The interphase delay between phases of the waveform is 400 ± 50 µsec.

EARTSTREAM CLINICAL SUMMARY AND AMERICAN HEART

ASSOCIATION DEFIBRILLATION STATEMENT

Overview and Objective

Heartstream conducted a study to assess the performance of our 150 J impedance-compensating biphasic waveform in the out-of-hospital setting on 100 consecutive victims of sudden cardiac arrest treated by a wide range of ﬁrst-responders, both traditional and non-traditional.

AEDs incorporating 150 J impedance-compensating biphasic waveforms were placed into service of 34 EMS systems. Data were obtained from the AED PC data card recording system. The ﬁrst endpoint was to determine the effectiveness of this waveform at terminating VF. Deﬁbrillation was deﬁned using the standard deﬁnition of conversion to an organized rhythm or to asystole. The second endpoint was to determine whether or not the use of such an AED culminated in an organized rhythm at the time of patient transfer to an advanced life support (ALS) team or

54 FORERUNNER

A PPENDIX B

Specifications

emergency department (ED). The third endpoint was to assess the efﬁciency of the human factors design of the AED by measuring user time intervals.

Results

Thirty-four sites provided data on 286 consecutive AED uses, 100 from SCA victims with VF as their initial rhythm upon attachment of the AED. All 286 patients were correctly identiﬁed by the AED as requiring a shock (100% sensitivity to the 100 VF patients) or not (100% speciﬁcity to the 186 patients not presenting in VF). The time from emergency call to ﬁrst shock delivery averaged 9.1+/- 7.3 minutes. A single 150 J biphasic shock deﬁbrillated the initial VF episode in 86% of patients. For all 450 episodes of VF in these 100 patients, an average of 86%+/- 24% of VF episodes was terminated with a single biphasic shock. Of the 449 VF episodes that received up to three shocks, 97%+/- 11% were terminated with three shocks or fewer. The average number of shocks per VF episode was 1.3+/- 0.7. The average time from AED poweron and pads attached to ﬁrst deﬁbrillation was 25+/- 23 seconds. At the time of patient transfer, an organized rhythm was present in 65% of patients presenting with VF. Asystole was the result in 25% of patients and VF was in progress in 10% of patients at the time of transfer.

Conclusions

Low-energy impedance-compensating biphasic waveforms

terminate long-duration VF at high rates in out-of-hospital

cardiac arrest and provide deﬁbrillation rates exceeding those

previously published with high-energy shocks. Use of this

waveform allows AED device characteristics consistent with

widespread AED deployment and early deﬁbrillation.

Gliner BE, et al. Treatment of out-of-hospital cardiac arrest with a low-energy impedancecompensating biphasic waveform automatic external deﬁbrillator. Biomedical Instrumentation & Technology, 1998;32:xx-xx.

User’s Guide 55

A PPENDIX B

Specifications

AMERICAN HEART ASSOCIATION DEFIBRILLATION STATEMENT

A recent (April 1998) scientiﬁc statement by the American Heart Association determined that the F

ORERUNNER’s

waveform is "safe, acceptable and clinically effective." In its conclusions, the AHA gave the use of the low-energy, impedance-compensating biphasic waveform a Class IIb recommendation, making it the only deﬁbrillation waveform to date to receive an AHA class recommendation.

56 FORERUNNER

SERVICE AND REPLACEABLE PARTS

A PPENDIX B

Specifications

There are no user serviceable components in the F

ORERUNNER. Contact Customer Service about returning a

ORERUNNER that has suspected operating problems.

Calibration is unnecessary as the FORERUNNER automatically performs daily self tests and correct operation is veriﬁed during the BIT. The F

ORERUNNER does not

require manual veriﬁcation of energy delivery because monthly automatic self tests verify the waveform delivery system. As a result, we do not publish Service/Maintenance and Repair Manuals for technical professionals.

Items that can be ordered routinely include:

• PC data cards and patient identiﬁcation labels

•F

ORERUNNER Training card

•F

ORERUNNER Setup card

•F

ORERUNNER battery pack

•F

ORERUNNER package containing deﬁbrillation pads,

cable, and connector

•F

ORERUNNER carrying case

• Mannequin adaptors

•F

ORERUNNER accessory software

Contact Customer Service or your local distributor for ordering information.

User’s Guide 57

A PPENDIX B

Specifications

58 FORERUNNER

A PPENDIX C

Glossary of Symbols

his appendix includes a glossary of symbols.

ORERUNNER Symbols

Screen Symbols

PC Card Symbols

Battery Symbols

User’s Guide 59

User’s Guide

A PPENDIX C

Glossary of Symbols

FORERUNNER SYMBOLS

Icon Description

On/Off button

•

Shock button

Manual override button

Contrast up button

Contrast down button

Deﬁbrillation protection

Turns the FORERUNNER on or off.

Delivers shock to patient when the FORERUNNER is charged.

Initiates manual override delivery of shock.

Increases the screen contrast or performs the function indicated on the screen.

Decreases the screen contrast or performs the function indicated on the screen.

Deﬁbrillation protected, type BF patient connection.

High voltage present.

Refer to operating instructions.

60 FORERUNNER

FORERUNNER

A PPENDIX C

Glossary of Symbols

SCREEN SYMBOLS

Icon Description

HR XX

HR - - -

XX:XX

Temperature

Setup

REV: XXXX XXXX

Heart Rate.

Heart Rate not available.

Number of shocks delivered.

Elapsed time since the FORERUNNER was turned on.

The recommended standby storage temperature range has been exceeded since the last BIT was performed. Check to assure that the FORERUNNER is stored within the range speciﬁed in Appendix B.

The setup options conﬁguration has been lost from memory. The FORERUNNER is using the default factory settings. To clear this message, use the Setup card described in Appendix A. If the message persists after you use the Setup card, call Customer Service.

The “REV” number identiﬁes the version of software and hardware used in your FORERUNNER.

User’s Guide 61

A PPENDIX C

Glossary of Symbols

PC CARD SYMBOLS

Icon Meaning

Training card

Setup card

Event Review card

Full ECG card

The Training card includes several simulated scenarios that guide students through several emergency events.

The Setup card allows you to conﬁgure options to match your program’s protocol.

Event Review recording capability.

Event Review with ECG recording capability.

Voice and ECG card

62 FORERUNNER

Event Review with ECG and voice recording capability.

A PPENDIX C

Glossary of Symbols

Icon Meaning

Insert

For use until

LOT

FOR USE UNTIL: 1998-02

123456789

Insert the data card into the FORERUNNER with this side up.

The PC data card contains a battery. Do not use the PC data card after the date indicated because the battery may be low or depleted.

User’s Guide 63

A PPENDIX C

Glossary of Symbols

BATTERY SYMBOLS

Icon Meaning

Do not crush the battery.

Do not expose the battery to high heat or open ﬂames. Do not incinerate.

Do not mutilate the battery or open the battery case.

Install Before

Install the battery in the FORERUNNER prior to the date indicated. Do not install the battery after this date.

Heavy metal substances. Do not dispose of improperly. Collect and recycle separately from household wastes.

64 FORERUNNER

A PPENDIX D

Dangers, Warnings, and Cautions

his Appendix includes the list of danger, warning, and caution messages.

CAUTION

Conditions, hazards, or unsafe practices that can result in minor personal injury, damage to the F of data.

ORERUNNER, or loss

WARNING

General

Deﬁbrillation

Monitoring

Maintenance

User’s Guide 65

User’s Guide

Conditions, hazards, or unsafe practices that can result in serious personal injury or death.

DANGER

Immediate hazards which will result in serious personal injury or death.

A PPENDIX D

Dangers, Warnings, and Cautions

GENERAL

Possible Shock or Fire Hazard or Explosion

DANGER: Possible explosion hazard if used in the presence of ﬂammable

anesthetics or concentrated oxygen.

WARNING: Improper use can cause injury. Use the FORERUNNER only as

CAUTION: Hazardous electrical output. This equipment is for use only by

qualiﬁed personnel.

CAUTION:

ﬂuids. Do not allow ﬂuids to enter the FORERUNNER. Avoid spilling any ﬂuids on the FORERUNNER or accessories. Spilling ﬂuids into the FORERUNNER may damage it or present a ﬁre or shock hazard. Do not autoclave or gas sterilize the FORERUNNER or accessories.

DANGER: The F

ardous locations as deﬁned in the National Electrical Code standard (Ar ticles 500-

503). In compliance with the IEC classiﬁcation (section 5.5) the ForeRunner is not to be used in the presence of ﬂammable substance/air mixtures.

Do not immerse any portion of the FORERUNNER in water or other

ORERUNNER has not been evaluated or approved for use in haz-

Possible Improper Device Performance

WARNING: Use only Heartstream disposable deﬁbrillation pads, batteries,

and other accessories supplied by Heartstream or its authorized distributors. Substitution of non-Heartstream accessories may cause the device to perform improperly.

CAUTION: Follow all deﬁbrillation pad labeling instructions. Use deﬁbrillation

pads prior to their expiration date. Discard deﬁbrillation pads after use. Do not reuse deﬁbrillation pads.

CAUTION: Follow all battery labeling instructions. Install the batter y prior to

the date noted on the battery.

WARNING: The BIT and periodic self tests are designed to assess the

FORERUNNER’s readiness for use. However, no degree of testing can assure performance or detect abuse, damage, or a defect which occurs after the last BIT or self test is completed.

CAUTION: Although the FORERUNNER is designed for a wide variety of ﬁeld use

conditions, rough handling beyond speciﬁcations can result in damage to the unit. (See Environmental Speciﬁcations in Appendix B.)

66 FORERUNNER

FORERUNNER

A PPENDIX D

Dangers, Warnings, and Cautions

WARNING: Aggressive or prolonged CPR to a patient with deﬁbrillation

pads attached can cause damage to the pads. Replace the deﬁbrillation pads if they become damaged during use.

WARNING: Use of damaged equipment or accessories may cause the

device to perform improperly and/or patient or user injur y.

WARNING: CPR rates above the American Heart Association guidelines of

100 BPM (beats per minute) can cause incorrect or delayed diagnosis.

Possible Electrical Interference with ECG monitoring

WARNING: Radio frequency (RF) interference from RF devices such as cel-

lular phones and two-way radios can cause improper FORERUNNER operation. In accordance with IEC standard 801.3, a distance of 2 meters (6 feet) between RF devices and the FORERUNNER is recommended.

DEFIBRILLATION

Possible Shock Hazard

Possible Patient Safety

Possible ECG Misinterpretation

WARNING: Do not place deﬁbrillation pads in the anterior-posterior position. A shock or no shock decision may be inappropriately advised. The FORERUNNER requires that the deﬁbrillation pads be placed in the anterioranterior position.

WARNING: Some very low amplitude or low frequency rhythms may not be

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

WARNING: Handling or transporting the patient during ECG analysis can cause incorrect or delayed diagnosis especially if ver y low amplitude or low fre-

User’s Guide 67

A PPENDIX D

Dangers, Warnings, and Cautions

quency rhythms are present. Following “Shock Advised” prompts, patient movement and vibration, if present, must be minimized for at least 15 seconds to allow reconﬁrmation of ECG analysis before delivering a shock. This reconﬁrmation of ECG analysis may result in an appropriate reversal of a "Shock Advised" prompt.

WARNING: In patients with cardiac pacemakers, the FORERUNNER may have

reduced sensitivity and not detect all shockable rhythms.

Possible Burns and Ineffective Energy

WARNING: Do not allow deﬁbrillation pads to touch each other, or to touch

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 hear t.

WARNING:

tion pads can cause patient skin burns. To help prevent air pockets, make sure self-adhesive deﬁbrillation pads completely adhere to the skin. Do not use dried out deﬁbrillation pads.

During deﬁbrillation, air pockets between the skin and deﬁbrilla-

MONITORING

Possible Misinterpretation of ECG Recordings

CAUTION: The LCD screen is intended only for basic ECG rhythm identiﬁca-

tion. The frequency response of the monitor screen is not intended to provide the resolution required for diagnostic and ST segment interpretation.

MAINTENANCE

Possible Fire or Shock Hazard

Possible Improper Device Performance

CAUTION: Improper maintenance can cause the FORERUNNER not to function. Maintain the FORERUNNER only as described in this User’s Guide or as instructed by your medical director.

68 FORERUNNER

I NDEX

accessories

available to order

maintaining adjust contrast during BIT AED overview analysis requirements for shock

decision applying defibrillation pads to the

patient artifact attaching pads

16, 23, 67

battery

conditions and Status Indicator

10, 21

dead or depleted

insertion

maintenance

position during cleaning

specifications

symbols

testing Battery Insertion Test (BIT)

how to interrupt

interactive tests biphasic waveform BIT. See Battery Insertion Test. burn hazard

11, 21

25, 27

47, 53

cautions, warnings, and

dangers charge

release when no shock

chirping

due to low battery or self test

due to setup card cleaning

instructions and precautions clock on PC data cards configurable options

delivered

failure

10, 26

connecting the defibrillation

pads

contamination continued use contraindications contrast buttons

used in Event Review contrast, adjusting controls and indicators corrective actions for error

conditions CPR

duration of pause

interrupting to analyze ECG

number of shocks between

pauses pause for protocol

damage

checks for mechanical to connector socket

danger, warnings, and cautions data card

compatibility installation reading removing verification during BIT

defibrillation pads

applied improperly applying expiration date maintaining placed improperly specifications

defibrillator shock

specification

defibrillator specifications depleted battery

and Status Indicator

device history DISARM disarming the F

15, 27, 66

ORERUNNER 17

11, 26

User’s Guide 69

I NDEX

display the Event Review,

how to

display, ECG

specifications

display, LCD

adjusting contrast during BIT

ECG

analysis during CPR data quality display option

(Model E only) misinterpretation monitoring and analysis patient analysis system

ECG display specification elapsed time of emergency

34, 35

electrical interference hazard electrode pads

See defibrillation pads.

electrode placement environmental specifications error conditions and corrective

actions

Event Review

about displaying information Full

Summary

explosion hazard

16, 67

21, 22

40 67, 68

16 48, 49 50

18,

factory settings 61

for setup options

failed self test

and the Status Indicator causes and corrective actions

failure

10, 21, 26

ORERUNNER Model E

capabilities options

ORERUNNER Model EM

and manual override mode

capabilities 37 options

40, 43

ORERUNNER Model S

capabilities options

Full Event Review

40, 43

heart rate

display option displayed on screen

heart rhythms

shockable how to configure options how to deliver shock how to display event review

information how to install the battery how to put the F

service how to use manual override mode

(Model EM only) HR in screen

2, 48

ORERUNNER into

impedance

error conditions and corrective

actions

improper device performance

hazard

indications and

contraindications information storage and

retrieval Install Before installing a data card installing battery installing Setup card interference

during pause for CPR

electrical

patient motion

proper distance from

radio frequency

16, 23, 67

RF sources

16, 67

LCD screen

adjust contrast

low battery

and Status Indicator

10, 26

maintaining

the connector socket

the defibrillation pads

the F

ORERUNNER 27

maintenance

after each use daily

weekly

mannequin adaptor

accessory for training

manual delivery of defibrillation

shock

MANUAL OVERRIDE manual override

disarming testing

manual override mode (Model EM

only) mechanical damage Model E options Model EM options Model S options monitoring

voice prompts suppressed

27, 28

new use 24 no shock advised number of shocks delivered

Full Event Review

in a single use

screen symbol

Summary Event Review

35 34 61

70 FORERUNNER

I NDEX

On/Off button

test

to discontinue self tests to interrupt the BIT

option

ORERUNNER Model E 37

ORERUNNER Model EM 37

ORERUNNER Model S 37

hide or display ECG trace

(Model E only)

manual override (Model EM

only)

19, 37

pause for CPR resume analyzing setup options speaker volume training

18, 41

19, 42

pacemaker

use with pad placement patient analysis system

performance patient analysis system

specifications patient safety hazard pause for CPR

configuring options

duration

interrupting PC data card

and accessory software

categories of

compatible versions

installation

maintenance

symbols

uses

verification during BIT periodic self test POST (Power On Self Test) power

16, 67

battery module

specifications

See On/Off button. preparing the patient prompts

setup options protocols for CPR

customizing

radio signal interference 16, 23,

recommended distances removing data card replaceable parts resume analysis during CPR

setup option RESUME ANALYZING

configuring option RF interference

16, 23, 67

screen

adjust contrast self test

adjust screen contrast

BIT

connector socket LED

discontinue and reschedule

failed

21, 25

interpreting results

manual override button

On/Off button

results

10, 26

shock button

shock button LED

speakers self test failure

and Status Indicator semi-automatic delivery of

defibrillating shock service and replaceable parts servicing the F setup

Setup card

10, 21

ORERUNNER 57

affecting Status Indicator 10 installing and using

setup options

factory settings general

40, 43

shock

CPR protocol delivering disarming in manual override

disarming in semi-automatic

not advised

shock button

testing and verification

shockable rhythms

and cardiac pacemakers shocks between CPR pauses speaker volume

adjusting speakers, testing specifications

battery

controls and indicators

defibrillation pads

defibrillator

defibrillator shock

ECG display

environmental

patient analysis system

PC data cards, training, and

physical

waveform standby temperature

Status Indicator

conditions and corrective

stored information about an

emergency Summary Event Review symbols

glossary of

mode (Model EM)

mode

setup cards

actions

10, 26

33, 34

40, 61

48, 49

7, 26, 46,

User’s Guide 71

I NDEX

technical specifications 46 technical support temperature, standby

time

elapsed

18, 35

of first shocks on PC data cards remaining in pause for CPR

timeout for CPR

duration interrupting

Training card

affecting Status Indicator

7, 26, 46,

use

appropriate symptoms elapsed time of number of shocks delivered with pacemakers

using the data card

voice prompts

setup options

volume

changing

warnings, dangers, and

cautions

waveform

specifications

when no shock is advised

X in Status Indicator, meaning 10

72 FORERUNNER

I NDEX

73 FORERUNNER

C HAPTER O NE

P/N 010136-0010

74 FORERUNNER

FORERUNNER EM User Guide

Specifications and Main Features

Frequently Asked Questions

User Manual