Powerheart AED 9200R, 9210R, 9200DR, 9210DR User manual

Powerheart AED Operation and Service Manual CAUTION

Powerheart AED is intended for use by or on the order of a Physician or persons licensed by State law.

IMPORTANT

Read this Operation and Service Manual carefully. It contains information about your safety and the safety of others. Become familiar with the controls and their proper use before operating the product.

The Powerheart AED Models 9200R/9210R/9200DR/9210DR are manufactured by Cardiac Science, Inc.

Corporate Headquarters:

16931 Millian Ave. Irvine, CA 92606 USA

Internet: www.cardiacscience.com Email: aed@cardiacscience.com

Manufacturer:

5420 Feltl Road Minneapolis, MN 55343-7982 USA

International:

Herstedvang 8 DK - 2620 Albertslund Denmark

Trademark Information

Powerheart , MDLink, Saving Minutes Saving Lives, SmartGauge, STAR, IntelliSense, RescueReady, RescueLink and Survivalink are trademarks and registered trademarks of Cardiac Science, Inc. Microsoft and Windows are registered trademarks of Microsoft Corporation. COMPACTFLASH is a trademark of SanDisk Corporation.

Limited Warranty

The Powerheart AED Operation and Service Manual and any and all information contained herein does not constitute any warranty as to the Powerheart AED or any related products in any manner whatsoever. The “Limited Warranty” is shipped with the Powerheart AED products and serves as the sole and exclusive warranty provided by Cardiac Science regarding the Powerheart AED.

Customer Service

For Customer Service, call: (800) 991-5465 (952) 939-4181 (952) 939-4191 (fax)

Technical Support

For 24-hour service, contact Technical Support at: (888) 466-8686 (952) 939-4181 (952) 939-4191 (fax)

There is no charge to the customer for a Technical Support call. Please have the serial and model numbers available when contacting Technical Support. (The serial and model numbers are located on the bottom of the Powerheart AED).

Notice of Rights

All rights reserved. No part of this documentation may be reproduced or transmitted in any form by any means without the express written permission of Cardiac Science, Inc. Information in this documentation is subject to change without notice. Names and data used in the examples are fictitious unless otherwise noted.

Defibrillator Tracking

Defibrillator manufacturers and distributors are required, under the Safe Medical Devices Act of 1990, to track the location of defibrillators they sell. Please notify Cardiac Science Technical Support in the event that your defibrillator is sold, donated, lost, stolen, exported, destroyed or if it was not purchased directly from Cardiac Science, Inc.

Table of Contents

Safety

Overview ........................................................................................................5

Safety Alert Definitions ...................................................................................6

Safety Alert Descriptions ................................................................................7

Symbols Descriptions ...................................................................................10

Introduction

Overview ......................................................................................................15

Powerheart AED Description .......................................................................16

Getting Started

Overview ......................................................................................................21

Unpacking and Inspecting ............................................................................22

Powerheart AED ..........................................................................................23

Powerheart AED Batteries ...........................................................................25

Electrodes ...................................................................................................27

Powerheart AED Indicators ..........................................................................28

Voice Prompt and Text Display Descriptions ...............................................32

Instructions for Use

Overview ......................................................................................................37

Step 1: Assessment and Electrode Placement ............................................38

Step 2: ECG Analysis ...................................................................................40

Step 3: Shock Delivery and CPR Mode .......................................................41

Step 4: Post Rescue .................................................................................42

Warnings .....................................................................................................43

Data Management

Overview ......................................................................................................45

Recording Rescue Data ...............................................................................46

Reviewing Rescue Data ...............................................................................47

Transfering Data to a Rescue Data Card .....................................................49

Table of Contents

Maintenance & Troubleshooting

Overview .........................................................................................51

Self-Tests........................................................................................ 52

Indicator Troubleshooting Table ......................................................53

Scheduled Maintenance ..................................................................55

Authorized Repair Service ..............................................................57

Frequently Asked Questions ...........................................................58

Technical Data

Overview .........................................................................................63

Parameters ......................................................................................64

Safety and Peformance Standards .................................................68

Summary of the RHYTHMx Clinical Study ......................................75

Accessories

Overview .........................................................................................77

List of Powerheart AED Accessories ..............................................78

Section 1 Safety

Overview

This section presents safety information to guard against injury to persons, and damage to the Powerheart AED.

Safety Alert Definitions 6 Safety Alert Descriptions 7 Symbols Descriptions 10

Topic Page

Section 1: Safety

Safety Alert Definitions

Before Operating the Powerheart AED:

Before operating the Powerheart AED, become familiar with the various safety alerts in this section.

Safety alerts identify potential hazards using symbols and words to explain what could potentially harm you, the patient or the Powerheart AED.

Safety Terms and Definitions

The triangle attention symbol shown below, left, identifies the potential hazard categories. The definition of each category is as follows:

DANGER: This alert identifies hazards that may cause serious personal injury or death.

WARNING: This alert identifies hazards that may cause serious personal injury or death.

CAUTION: This alert identifies hazards that may cause minor personal injury, product damage, or property damage.

The term “Powerheart AED” refers to Models 9200R/9210R/9200DR/ 9210DR..

Section 1: Safety

Safety Alert Descriptions

The following is a list of Powerheart AED safety alerts that appear in this section and throughout this manual. You must read, understand, and heed these safety alerts before attempting to operate the Powerheart AED.

DANGER: Fire and Explosion Hazard Exercise caution when operating the Powerheart AED close to flammable

gases (including concentrated oxygen) to avoid possible explosion or fire hazard.

WARNING: Shock Hazard Defibrillation shock current flowing through unwanted pathways is

potentially a serious electrical shock hazard. To avoid this hazard during defibrillation abide by all of the following:

• Do not touch the patient, unless performance of CPR is indicated

• Do not touch metal objects in contact with the patient

• Keep defibrillation electrodes clear of other electrodes or metal parts in contact with the patient

• Disconnect all non-defibrillator proof equipment from the patient before defibrillation

WARNING: Shock and Possible Equipment Damage Disconnect all non-defibrillator proof equipment from the patient before

defibrillation to prevent electrical shock and potential damage to the equipment.

WARNING: Battery is Not Rechargeable Do not attempt to recharge the battery. Any attempt to recharge the

battery may result in an explosion or fire hazard. CAUTION: Possible Radio Frequency (RF) Susceptibility

RF susceptibility from cellular telephones, CB radios, and FM 2-way radio may cause incorrect rhythm recognition and subsequent shock advisory.

When attempting a rescue using the Powerheart AED, do not operate wireless radiotelephones within 1 meter of the Powerheart AED—turn power OFF to the radiotelephone and other like equipment near the incident.

Section 1: Safety

CAUTION: Moving the Patient During a Rescue During a rescue attempt, excessive jostling or moving of the patient may

cause AEDs to interrupt the ECG analysis. The prompt “Noise Detected. Stop Patient Motion” will be issued and analysis of the ECG will restart. It is recommended that you stop moving the patient and turn off cellular telephones or other electronics nearby.

CAUTION: Use only Cardiac Science Approved Equipment Using batteries, electrodes, cables, or optional equipment other than those

approved by Cardiac Science may cause the Powerheart AED to function improperly during a rescue.

CAUTION: Serial Communication Cable The Powerheart AED will not perform a rescue when a serial

communication cable is connected to its serial connector. The voice prompt will say “Remove Cable to Continue Rescue.”

CAUTION: Possible Interference With Implanted Pacemaker The Powerheart AED may not advise a defibrillation shock when the

patient has an unipolar implanted pacemaker.1 However, a defibrillation attempt should be made with the following precautions.

• Do not place the electrodes directly over an implanted device

• Place the electrode pad at least one inch from any implanted device

CAUTION: Lithium Sulfer Dioxide Battery Pressurized contents; never recharge, short circuit, puncture, deform, or

expose to temperatures above 65°C (149°F). Remove the battery when discharged.

CAUTION: Battery Disposal Recycle or dispose of the lithium battery in accordance with all federal,

state and local laws. To avoid fire and explosion hazard, do not burn or incinerate the battery.

CAUTION: Temperature/Humidity/Pressure Extremes Exposing the Powerheart AED with the battery installed to extremes,

outside the following operation and standby conditions, will cause the self-tests to be disabled and could cause the Powerheart AED to function

1. Cummins, R., ed., Advanced Cardiac Life Support; AHA (1994): Ch. 4.

Section 1: Safety

improperly. Storing the Powerheart AED outside the stated temperature conditions for 5 consecutive days will result in a “service required” alert.

• Temperature 0°C to 50°C (32°F to 122°F)

• Humidity 5% to 95% (non-condensing)

• Pressure 57kPa (+15,000 ft) to 170kPa (-15,000 ft)

Section 1: Safety

Symbols Descriptions

The following symbols appear in this manual, on the Powerheart AED, or on its optional components. Some of the symbols represent standards and compliances associated with the Powerheart AED and its use.

Dangerous Voltage: The defibrillator output has high voltage and can present a shock hazard. Please read and understand all safety alerts in this manual before attempting to operate the Powerheart AED.

Attention!: Identifies important information in this manual, on the Powerheart AED, or on its component parts regarding the safe and proper use of the Powerheart AED.

Defibrillator Proof Type BF Equipment: The Powerheart AED, when connected to the patient’s chest by the electrodes, can withstand the effects of an externally applied defibrillation shock without diverting the shock from the patient or into the Powerheart AED.

CE Mark: This equipment conforms to essential requirements of the Medical Device Directive 93/42/EEC.

IP23

The Powerheart AED is protected against the effects of spraying water in accordance with IEC 529.

Classified by Underwriters Laboratories Inc. with respect to electric shock, fire and mechanical hazards only in accordance with UL 2601-1 and IEC 601-2-4, IEC SC 62D/WG2 (O’Dowd) and CAN/CSA C22.2 No.601.1-M90.

International symbol for ON. Open the lid to turn ON the Powerheart AED.

Section 1: Safety

TSO-C97

FAA TSO marking: This battery conforms to the FAA lithium sulfer dioxide batteries technical standard order, TSO C97.

International symbol for OFF. Close the lid to turn OFF the Powerheart AED.

Open the lid to turn ON the Powerheart AED.

Indicates the Powerheart AED battery status. The shaded areas indicate the remaining battery capacity.

Check the electrodes when illuminated. The electrodes are either missing or out of specification. Also, on the electrode packaging, this symbol represents one pair.

When illuminated indicates Powerheart AED requires maintenance by authorized service personnel.

When flashing, push this button to deliver a defibrillation shock.

When flashing: push this button to clear the internal memory to allow storage of new rescue data in the Powerheart AED.

Section 1: Safety

RED with a BLACK X means the Powerheart AED requires operator attention or maintenance, and is not RescueReady. For purposes of retaining simple, clear instructions, this symbol will be referred to as RED in the remainder of this manual.

GREEN without a BLACK X means the Powerheart AED is RescueReady. For purposes of retaining simple, clear instructions, this symbol will be referred to as GREEN in the remainder of this manual.

Use by or install by date.

Expiration Date. Replace by this date.

Latex Free.

Disposable. Single patient use only.

Tear here to open.

Do not recharge battery.

The patient is unconscious.

Section 1: Safety

The patient is not breathing.

Place the electrodes on the chest of the patient.

For use by or on the order of a Physician, or persons licensed by state, province or country law.

Dispose of properly in accordance with all state, province, and country regulations.

Do not incinerate or expose to open flame.

Explosion Hazard: Do not use in the presence of a flammable gas, including concentrated oxygen.

Upper and lower temperature limits.

Serial Number.

Section 1: Safety

Lot Number.

Date of Manufacture.

Additional information is provided in the Powerheart AED Operation and Service Manual.

Points to important information regarding the use of the Powerheart AED.

Lift Here

Section 2 Introduction

Overview

This section presents information about the Powerheart AED, its use, and the training requirements for operation.

Topic Page

Powerheart AED Description 16 Indications for Use 16 Contraindications for Use 16 Powerheart AED ECG Analysis Algorithm 17 Powerheart AED Rescue Protocol 18 Powerheart AED STAR Biphasic Waveform 19 Powerheart AED Operator Training Requirements 19

Section 2: Introduction

Powerheart AED Description

The Powerheart AED is a self-testing battery-operated automated external defibrillator (AED). After applying the Powerheart AED’s electrodes to the patient’s chest, the Powerheart AED automatically analyzes the patient’s electrocardiogram (ECG) and advises the user to push the button and deliver a shock if needed. The Powerheart AED uses one button and guides you through the rescue using a combination of voice prompts, audible alerts, and visible indicators.

Indications for Use

The Powerheart AED with STAR Biphasic is intended to be used by personnel who have been trained in its operation. The user should be qualified by training in basic life support or other physician-authorized emergency medical response. The device is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrythmia recurs, the device will charge automatically and advise the operator to deliver therapy. The Powerheart AED with STAR Biphasic is intended to be used on patients older than eight years.

Patients at risk of cardiac arrest include persons that:

• Are not responsive

• Are not conscious

• Are conscious and have just been revived by a defibrillator shock

• Are conscious and complain of dizziness, and/or chest pain

• Suffers from syncopy (fainting spells)

• Suffer shortness of breath

• Experience unexplained palpitation, coldness or sweat

• Experience radiating pain from the neck to the shoulder

• Experience unexplained chest pains.

Contraindications for Use

Do not use the Powerheart AED for emergency treatment if the patient is under eight years of age.

Section 2: Introduction

Powerheart AED ECG Analysis Algorithm

The Powerheart AED ECG analysis algorithm, provides superior ECG detection capabilities allowing it to be placed on patients at risk for sudden cardiac arrest. The features available with the Powerheart AED include the following:

• Detection Rate

• Supraventricular Tachycardia (SVT) Rate

• SVT Discriminators

• Asystole Threshold

• Noise Detection

• Continuous Monitoring

• Non-Committed Shock

• Synchronized Shock

• Pacemaker Signal Detection

Detection Rate

All ventricular fibrillation (VF) and ventricular tachycardia (VT) rhythms at or above this rate will be classified as shockable. All rhythms below this rate will be classified as non shockable. The default Detection Rate is 160 bpm (beats per minute). This rate is selectable between 120 bpm and 240 bpm via MDLink Software by the Medical Director.

SVT Rate

All rhythms with rates between the Detection Rate and SVT Rate will be screened through a number of SVT Discriminator to classify them into VF/VT or SVT. Rhythms classified as SVT between the two set rates are not shockable. All rhythms at or above the SVT Rates will be shockable. The default SVT Rate is 200 bpm. The SVT rate must be greater than or equal to the Detection Rate and is selectable between 160 and 240 bpm via MDLink Software by the Medical Director.

SVT Discriminators

These are sophisticated filters that analyze the morphology of the ECG waveforms and distinguish VF/VT from SVT and Normal Sinus Rhythms (NSR). The SVT Discriminator will only be applied to rhythms that fall between the Detection Rate and the SVT Rate.

Section 2: Introduction

Asystole Threshold

The asystole peak to peak threshold is set at 0.08 mV. ECG rhythms at or below 0.08mV will be classified as Asystole and will not be shockable.

Noise Detection

The Powerheart AED will detect noise artifact in the ECG. Noise could be introduced by excessive moving of the patient or electronic noise from external sources like cellular and radio telephones. When noise is detected, the Powerheart AED will issue the prompt “Analysis interrupted. Stop Patient Motion” to warn the user. The Powerheart AED will then proceed to reanalyze the rhythm and continue with the rescue.

Continuous Monitoring

Powerheart AED monitors the ECG rhythms continuously throughout the rescue including during Charge and CPR mode. Continuous Monitoring will interrupt CPR if a shockable rhythm is detected. When CPR is interrupted, the prompt “Do not touch patient. Analyzing rhythm” will be issued. Only one interruption will be allowed during a single CPR mode. CPR mode will not be interrupted if preceded by three consecutive shocks.

Non-Committed Shock

After the Powerheart AED advises a shock, it continues to monitor the patient ECG rhythm. If the patient’s rhythm changes to a non-shockable rhythm before the actual shock is delivered, the Powerheart AED will advise that the rhythm has changed and issue the prompt “Rhythm changed. Shock cancelled.” The Powerheart AED will then be disarmed and the ECG reanalyzed.

Synchronized Shock

Powerheart AED is designed to synchronize shock delivery on the Rwave. If delivery cannot be synchronized within one second of the button being pressed, a non-synchronized shock will be delivered.

Powerheart AED Rescue Protocol

The Powerheart AED rescue protocol is consistent with the guidelines recommended by the American Heart Association (AHA)1 and the International Liaison Committee on Resuscitation (ILCOR).

Section 2: Introduction

Upon detecting a shockable cardiac rhythm, the Powerheart AED advises you to press the “Shock” button to deliver a series of up to 3 defibrillation shocks followed by performing 1 minute of CPR.

The 3 defibrillation shocks are delivered in a pre-programmed sequence of escalating biphasic energies in the default configuration.

Note: The CPR protocol can be modified, such that from 1 to 3 minutes, in

increments of 5 seconds, of CPR may be administered if the first analysis is non-shockable or following two consecutive nonshockable analysis decisions.

Powerheart AED STAR Biphasic Waveform

The Powerheart AED STAR Biphasic Waveform is designed to measure the patient’s impedance and deliver a customized shock. This allows the delivery of an optimized energy level to each patient. The energy levels for the Powerheart AED are available in three different defibrillation shock2 configurations. See table below.

9200R/9210R/

Defibrillation Shock

9200DR/9210DR

AED

Configurations

Standard Energy Low

Low Energy Ultra-Low

1st

Shock

Current

2nd

Shock

Low Current or High Current

Ultra-Low Current or Low

3rd

Shock

High Current

Low Current

Current

Non-escalating Energy

Low Current

Low Current Low

Current

Powerheart AED Operator Training Requirements

Persons authorized to operate the Powerheart AED must have all of the following minimum training and experience:

• Defibrillation training and other training as required by state, province, or country regulations

1. “Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care” American Heart Association; 2000. Suppl. Circulation 102(8). August 22, 2000

2. The ultra-low current, low current and high current shocks are variable energy. The actual energy is determined by the patient’s impedance.

Section 2: Introduction

• Training on operation and use of Powerheart AED

• Additional training as required by the physician or Medical Director

• A thorough understanding of the procedures in this manual

Keep certificates of training and certification as required by state, province, or country regulations.

Section 3 Getting Started

Overview

This section presents information on unpacking and setting up the Powerheart AED.

Topic Page

Unpacking and Inspecting 22 Powerheart AED 23 Batteries 25 Electrodes 27 Powerheart AED Indicators 28 Setting Clock 30 Voice Prompts and Text Display 32

Section 3: Getting Started

Unpacking and Inspecting

Every attempt is made to ensure your order is accurate and complete. However, to be sure that your order is correct, verify the contents of the box against your packing slip.

If you have any question about your order, contact our Customer Service

Department at: (800) 991-5465 or (952) 939-4181 or your local distributor. For customers from countries outside of the United States, contact your local distributor.

Section 3: Getting Started

Powerheart AED

The following drawings show the Powerheart AED parts and their locations.

A = Lid B = Latch (push in and up to

open) C = Status indicator D = Data access door E = Battery compartment

F = Speaker G = Electrode connector H = Diagnostic panel I = Card Slot (model 9210R and

9210DR) J = Serial communication port K = Spare flash card storage L = Optional text display

The Powerheart AED has three modes of operations: Operating Mode - is defined as having the battery installed and the lid

open. This is the mode the Powerheart AED would be in during an actual rescue situation.

Section 3: Getting Started

Standby Mode - is when the battery is installed, but the lid is closed. In this mode the Powerheart AED is not being used in a rescue, the device will conduct its routine self-tests to ensure proper operation.

Storage Mode - is when the battery is removed, such as during shipping or transport. With the battery removed, the Powerheart AED is unable to perform self-tests or rescues.

Powerheart AED Operating and Standby Conditions

Temperature 0°C to 50°C (32°F to 122°F) Humidity 5% to 95% (non-condensing) Atmospheric Pressure 57kPa to 170kPa

CAUTION: Temperature/Humidity/Pressure Extremes Exposing the Powerheart AED with the battery installed to extremes,

outside the operation and standby conditions, will cause the self-tests to be disabled and could cause the Powerheart AED to function improperly. Storing the Powerheart AED outside these conditions for 5 consecutive days will result in a “service required” alert.

Powerheart AED Shipping and Transport Conditions

(for up to 1 week)

Temperature w/o Display -40°C to 65°C (-40°F to 149°F) Temperature w/Display -30°C to 65°C (-22°F to 149°F) Humidity 5% to 95% (non-condensing) Atmospheric Pressure 57kPa to 170kPa

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