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Appendix 2. Standards Applied
The Ambu aScope 3 function conforms with:
- Council Directive 93/42/EEC concerning Medical Devices.
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for safety.
- IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the safety of endoscopic equipment.
- ISO 8600-1: Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements.
- IEC 60601-1-2: Medical electrical equipment – Part 1-2 General requirements for safety – Collateral standard: Electromagnetic compatibility - Requirements
for test.
- ISO 594-1: Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements.
- ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and testing
The Ambu aView function conforms with:
- Council Directive 93/42/EEC concerning Medical Devices.
- IEC 60601-1 Medical electrical equipment – Part 1: General requirements for safety.
- EN 60601-1-1 Medical electrical equipment – Part 1: General requirements for safety– Collateral standard: Electromagnetic compatibility - Requirements
for test.
The Ambu aView power supply conforms with:
- Council Directive 93/42/EEC concerning Medical Devices.
- IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety.
- EN 60601-1-1 Medical electrical equipment - Part 1: General requirements for safety– Collateral standard: Electromagnetic compatibility - Requirements
for test.
Appendix 3. Warranty and Replacement Program
The warranty period for the Ambu aView is one year from delivery to the customer. We agree to replace an aView free of
charge if proof can be provided of faulty materials or faulty workmanship. In doing so we cannot accept the cost of transportation or risk of shipment.
There is no warranty on the Ambu aScope 3.
A defective aView must be handled exclusively by persons authorised by Ambu A/S. During our inspection of the aView you will receive an identical
replacement of the aView.
To prevent infection, it is strictly forbidden to ship contaminated medical devices. The medical device (aView or aScope 3) must
be decontaminated on site before shipment to Ambu. The cleaning and disinfection procedures explained in 4.1 and 4.2 shall be followed. Ambu
reserve the right to return contaminated medical devices to the sender.
