Defibrillator,AED,w/access

GENERAL DESCRIPTION
Compact fully automatic external (AED) defibrillator including Cardiopulmonary Resuscitation (CPR) support feature.

INTENDED USE
Fully automated external defibrillators (AEDs) deliver a high-voltage electrical impulse to the heart in order to restore normal rhythm and contractile function in patients who are experiencing ventricular fibrillation (VF) or ventricular tachycardia (VT) that is not accompanied by a palpable pulse. AEDs differ from conventional manual defibrillators in that AEDs can analyse the ECG rhythm to determine whether defibrillation is necessary; this eliminates the need for the user to interpret the cardiac rhythm before delivering a shock. AEDs are designed for use primarily by first responders to cardiac emergencies, who may not be fully trained in advanced cardiac life support (ACLS). In the prehospital setting, these emergency personnel can include EMTs, firefighters, and law enforcement officers. Flight attendants, security guards, and others −sometimes called targeted responders may be expected to use PAD units. AEDs can also be used in areas of the hospital where advanced life support personnel are not readily available.

TECHNICAL SPECIFICATIONS
Adult and paediatric settings.
Biphasic output waveform
Automatic ECG (VT/VF) detection and analysis.
Automatic impedance compensation based on patient.
Paediatric dose attenuation.
Automatic switch between AED and CPR modes based on analysis.
Analysis time less than 10 seconds after having been switched on.
Maximum energy output for adults between 150 and 200 Joules.
Maximum energy output for paediatrics 50 Joules, or adjustable between 30 and 70 (depending on the model supplied).
Charge time to maximum energy output is 5 seconds.
Includes step-by-step device and CPR user guide, either in durable plastic-coated manual and/or on machine.
Audible metronome for CPR procedure.
Built-in discharge feature for safety.
Integrated control panel with all parameters and controls.
Step-by-step pictograms on the control panel for ready and easy operation.
Audio and/or visual indications of operational status and step-by-step operation.
Audio and/or visual alarms for operational status, electrodes, battery status and system errors.
Automatic self-test and continuous check of pads and electrodes connection.
Conductive surface area of adult electrodes is at least 80 cm²
Conductive surface area of paediatric electrodes is at least 80 cm²
Shelf life of electrodes is at least 2 years.
Replaceable internal battery, non-rechargeable.
Battery type LiSO2 or LiM no (depending on the model supplied).
The internal battery, when full supports at least 140 full discharges at 200J, or two hours continuous ECG monitoring.
Weighs less than 3 kg.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x carry case, with storage pockets for leads and accessories.
3 x set of adult adhesive external pads, colour-coded and with pictograms.
3 x set of paediatric adhesive external pads, colour-coded and with pictograms.
1 x plastic enclosed Quick Reference Guide (step-by-step AED and CPR).
1 x CD-ROM/DVD/USB with training material.
2 x sets of spare batteries, packed separately.

ESTIMATED LIFE SPAN
10 years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 0°C - 50°C / 10 % – 95% RH.
- Storage conditions: -10°C - 50°C / 10% – 95% RH.
- Atmospheric pressure up to 700 hPa (altitude of 3,000m).
- Ingress protection rating: IP44.

WEIGHT AND VOLUME
Weight: 5.00 kg.
Volume: 45.00 dm³.

ESTIMATED DELIVERY LEAD TIME
120 days.

INSTALLATION REQUIREMENTS
This product does not require assembly or commissioning.

TRAINING REQUIREMENTS
Not training required, instructions for use provided on the device and through verbal instructions when the device is deployed.

MAINTENANCE/USER REQUIREMENTS
No maintenance required.

RELATED PRODUCTS
S0002062, ECG recorder,portable,w/access

ALTERNATIVE PRODUCTS
S0002059, Defibrillator,basic,w/access

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

CLASSIFICATION
Classified either under EU MDD 93/42/ECC, or under EU MDR 2017/745 as Class III device.

SAFETY & PRODUCT STANDARDS
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- IEC 60601-2-4:2010+AMD1:2018 CSV Consolidated version Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators.

NOMENCLATURE
- GMDN code: Non-rechargeable professional semi-automated external defibrillator (48049), Non-rechargeable public semi-automated external defibrillator (47910), Non-rechargeable public automated external defibrillator (48047).
- UMDNS code: Defibrillators, External, Automated (17116), Defibrillators, External, Semiautomated (18500).