Automated External Defibrillator ______________________________________________________________

GENERAL SPECIFICATIONS

Dimensions:

Height - 29.0 cm. Width - 22.0 cm. Depth - 13.0 cm.

Weight: with Battery - 2.9 kg.

Waveform: Biphasic Truncated Exponential. Wave form parameters set according to the patient's impedance.

Defibrillation Energy (factory preset) :

Adult: 1st shock 150 Joules, subsequent shocks 200 Joules. Child: 50 Joules.

Pads size:

Adult = area: 82 cm2. Child = rea: 30 cm2

Adult/Child Selection : Automatic by the type of pads.

Voice Instructions : Voice instructions guide the responder through each step of the use of the

defibrillator. CPR prompts include a Metrinome tone (beat) to aid with chest compression rate.

Screen Icons :

Icons representing each key stage of the defibrillation procedure, sequentially light up on the front screen, illustrating the voice directions given by the device.

Ph: 1300 411 973 Fax: 03 9877 1643 Emai l : sa les@sasyachook .com.au w w w . s a s y a c h o o k . c o m . a u

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Testing Procedures : ISIS undertakes a full Auto-Test WEEKLY and whenever the device is turned ON. The operational status of the device is notified by : (i) Visual Indicators, (ii) Voice Messages, (iii) Sound Signals. Visual Indicators :

Green Ready Icon – shows that the defibrillator is operational and ready for use. Red Icon – low battery charge.

If a problem is found during Auto-Testing, the voice message “problem with the automatic test” is issued, together with the visual indication of failure.

ISIS may issue audible electronic beeps, which can be interpreted as follows :

Battery:

Type: Lithium-Ion (Li-ion), 14.4 VDC 4.0 A/h. Re-chargeable. Minimum 200 shocks at 200 Joules (battery under good conditions). Duration:10 hours in cardiac rhythm recognition mode (fully charged battery). Battery Re-Charge time – 5 hours from complete discharge, to full charge. Service Life is at least 500 cycles (full charges & discharges).

Continous Charging : The ISIS defibrillator can be permanently connected to electrical current, without damaging its batteries. This eliminates the need to periodically check and re-charge the batteries. Battery Storage :

• Storage - long periods in temperatures above 35ºC will reduce the battery's capacity and shorten its useful life.

Sound Indicators :

Two Beeps - CPU Board failure Four Beeps - Discharged Battery. Three Beeps - Defibrillation Module failure.

Five Beeps - Battery Module failure.

Voice Message :

Controls : Turn On Analyse Apply Shock 1st Press 2nd Press

On/Off : Single Front Panel Button. Shock : Front Panel Button, when Blinking. Charge : Automatic after identifying arrhythmias that should receive shock.

Shock-to-Shock Cycle Time : Maximum time from start of rhythm analysis until discharge - 20 secs. Maximum time from start of operation until discharge at maximum energy 25 secs. Charge Time to max. Joules is less than 10 secs.

Warranty : Device warranty – 3 years. Rechargeable Battery - 2 years. Pads – 2 years.

Memory Storage: 100 events or 2 hours of ECG record.

Mode of operation: Continuous Operation.

Maximum output voltage: 1500 V. Maximum

Output Current: 60 A (25 ohms).

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STANDARDS European Certificate CE O499 – Full Quality Assurance System.

Directive 93/42/EEC. • NBR IEC 60601-1:1997 (IEC60601-1:1995), Medical Electrical Equipment – Part 1 –

General Requirements for Safety. • EN 60601-1:1990, (Amendment, A1:1993, A2:1995, A13:1996) (IEC 60601-1:1988, A1:1991, A2:1995), Medical electrical equipment - Part 1 – General Requirements for Safety • NBR IEC 60601-1-2:2006 (IEC60601-1-2:2004), Medical Electrical Equipment – Part 1-2 –

General Requirements for Safety: Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.

• EN 60601-1-2:2007 (IEC 60601-1-2:2007), Medical electrical equipment. General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

• ABNT NBR IEC 60601-1-4:2004 (IEC 60601-1-4:2000) Medical Electric Equipment - Part 1-4: General Requirements for Safety: Collateral Standard: Programmable electrical medical systems.

• IEC 60601-1-4:2000 - Medical electrical equipment - Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems.

• NBR IEC 60601-2-4:2005 (IEC60601-2-4:2002), Medical Electrical Equipment – Part 2 - • Particular requirements for the safety of Cardiac Defibrillators. • EN 60601-2-4:2003 (IEC 60601-2-4:2002), Medical electrical equipment. Particular

requirements for safety. Particular requirements for the safety of cardiac defibs. • ANSI/AAMI DF80:2003: Particular requirements for the safety of cardiac defibrillators

(including automated external defibrillators). NBR IEC/CISP