Standards Applied - Ambu aView Instrucciones De Uso

Disinfecting
Wipe the surfaces of aView for approximately 15 minutes using a piece of sterile gauze
moistened with the alcohol mixture indicated below (approximately once every 2 min-
utes). Follow safety procedures for the handling of isopropyl. The gauze should be moist
and not dripping since liquid can affect the electronics inside the aView. Pay close atten-
tion to the button, rubber covers, screen, external casing and stand, slots and gaps on the
aView. Use a sterile cotton swab for these areas.
Solution: Isopropyl (alcohol) 95%; Concentration: 70-80%; Preparation: 80cc of 95% Isopro-
pyl (alcohol) added to 20cc of purified water (PURW) (Alternatively, use EPA-registered hos-
pital disinfection wipes containing at least 70% isopropyl. Safety precautions and direc-
tions of use of the manufacturer must be followed).
After cleaning and disinfection, the aView must be submitted to the pre-check procedure in section 4.1.
Between procedures, aView must be stored in accordance with local guidelines.
6. Maintenance and Disposal
6.1. Maintenance of Battery
To prolong battery life it is recommended to fully charge the monitor at least every third
month and store it in a cool place. If the battery is flat the procedure can take up to 5 hours.
The battery should be charged at temperatures between 10 - 40°C.
6.2. Disposal
At the end of product life open up the aView and dispose of the batteries and aView separately
in accordance with local guidelines.
7. Technical Product Specifications

7.1. Standards Applied

The aView function conforms with:
– Council Directive 93/42/EEC concerning Medical Devices.
– IEC 60601-1 ed 2 Medical electrical equipment – Part 1: General requirements for safety.
– IEC 60601-1 ed 3.1 Medical electrical equipment - Part 1: General requirements for basic safe-
ty and essential performance.
– IEC 60601-1-2: Medical electrical equipment – Part 1-2 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 ed 2 Medical electrical equipment – Part 1: General requirements for safety.
– IEC 60601-1 ed 3.1 Medical electrical equipment - Part 1: General requirements for basic safe-
ty and essential performance.
7.2. aView Specifications
Display
Max. resolution
Orientation
Display type
Brightness control
Contrast control
Start up time
800 * 480
Landscape
8.5" colour TFT LCD
Yes, ("+" / "-")
Yes, ("+" / "-")
Immediately after pressing the power button.
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