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Philips M5066A ECG analysis performance

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E-6

Philips Medical Systems

HEARTSTART M5066A

ECG analysis performance

rhythm class ECG test

samplea size

meets AHA recommendationsb for adult defibrillation

observed 90% one-sided

performance lower confidence limit

shockable rhythm —

ventricular fibrillation

300 sensitivity >90%

(meets AAMI DF80 requirement)

(87%)

shockable rhythm —

ventricular tachycardia

100 sensitivity >75%

(meets AAMI DF80 requirement)

(67%)

non-shockable rhythm —

normal sinus rhythm

300 specificity >99%

(meets AAMI DF80 requirement)

(97%)

non-shockable rhythm —

asystole

100 specificity >95%

(meets AAMI DF80 requirement)

(92%)

non-shockable rhythm —

all other non-shockable

rhythmsc

450 specificity >95%

(meets AAMI DF80 requirement)

(88%)

a. From Philips Medical Systems Heartstream ECG rhythm databases.

b. American Heart Association (AHA) AED Task Force, Subcommittee on AED Safety & Efficacy. Automatic External Defibrillators for Public

Access Use: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporation of New

Waveforms, and Enhancing Safety. Circulation 1997;95:1677-1682.

c. Supraventricular tachycardia (SVT) is specifically included in the non-shockable rhythm class, in accordance with AHA recommendationsb

and the AAMI standard DF80.

Contents

Main Page The HeartStar t Defibrillator M5066A Ready Light. On/Off Button. Information Button. Caution Light. Page Page Page HeartStar t Page About this edition Edition history Copyright Authorized EU representative CAUTION: Page CONTENTS 1 Introduction to the HeartStart 2 Setting up the HeartStart 3 Using the HeartStart 4 After using the HeartStart Page 1 1 Introduction to the Hear tStart Description Sudden Cardiac Arrest Indications for Use Training and practice National and local requirements For more information 2 2 Setting up the HeartStart Package contents Setting up the HeartStart Page Page Recommended accessories 3 Using the HeartStar t Overview STEP 1: PULL the green handle STEP 2: PLACE the pads STEP 3: PRESS the Shock button Treating infants and children When emergency m edical services arr ive Page Page 4 4 After using the HeartStar t After each use HeartStart data storage Page 5 5 Maintaining the HeartStar t Routine Maintenance Periodic checks Cleaning the HeartStart Disposing of the HeartStart Troubleshooting tips A A Accessories for the Hear tStart Page B BGlossary of terms Page B Page C C Glossary of symbols/controls Page C symbol description D D Warnings and precautions Warni ngs Precautions E Technical information HeartStart Defibrillator specifications Environmental Physical Controls and indicators Defibrillation Waveform Page ECG analysis system ECG analysis performance Accessories specificatio ns Battery M5070A HeartStart Environmental considerations FConfiguration Overview Device options Patient treatment protocol options Page Page Page Page G G Testing and troubleshooting Tes t i n g Troubleshooting Recommended action during an emergency Troubleshooting while the HeartStart is in use G Troubleshooting while the HeartStart is not in use H H Additional technical information required for European conformity Electromagnetic conformity Electromagnetic emissions Electromagnetic immunity H Important warnings and reminders Environmental considerations Page Page Page Page Page Philips Medical Systems is part of Royal Philips Electronics REF: M5066-91901