EN
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
safety 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
safety and essential performance.
7.2. aView Specifications
Display
Max. resolution
800 * 480
Orientation
Landscape
Display type
8.5” colour TFT LCD
Brightness control
Yes, (“+” / ”-“)
Contrast control
Yes, (“+” / ”-“)
Start up time
Immediately after pressing the power button.
Connections
USB connection
Type A
Analog composite video out
RCA connection (use adapter cable included)
Storage and transportation
Temperature
10 ~ 40°C (50 ~ 104°F)
Relative humidity
30 ~ 85%
Atmospheric pressure
80-109 kPa
Memory
Storage capacity
8GB
Mounting interface
Mounting interface standard
VESA MIS-D, 75 C, VESA FDMI compliant display,
Part D, with centre located mounting interface
Electrical power
Power requirement
18V 1.67A DC input
4.4. After Use
Final steps
1.
Disconnect the Ambu visualization device from aView. For disposal of the visualisation
device, refer to the Instruction for Use of the specific device.
2.
Switch off aView by pressing the power button
for at least 2 seconds. A blue
hourglass indicating that aView is powering down will appear on the screen and
aView will power down.
3.
Clean and disinfect aView (cf. section 5).
4.
If the battery level of aView is low, charge the aView (cf. section 4.1).
5. Cleaning and Disinfection of aView
The aView should be cleaned and disinfected before and after each use. It is recommended that
aView is cleaned and disinfected before and after use following the instructions below. Ambu
has validated these instructions in accordance with AAMI TIR 12 & 30. Any deviation from the
instructions should be properly evaluated for effectiveness and potential adverse consequences
by the reprocessor, to ensure that the device continues to fulfil its intended purpose.
Clean and disinfect the aView according to good medical practice using one of the procedures below:
Cleaning
1.
Prepare a cleaning solution using a standard enzymatic detergent prepared per
manufacturers recommendations. Recommended detergent: enzymatic, mild pH: 7-9,
low foaming (Enzol or equivalent).
2.
Soak a sterile gauze in the enzymatic solution and make sure that the gauze is moist and
not dripping.
3.
Thoroughly clean the button, rubber covers, screen, external casing of the monitor and
stand with the moist gauze. Avoid getting the device wet to prevent damaging internal
electronic components.
4.
Using a sterile soft bristled brush that has been dipped in the enzymatic solution,
brush the button until all evidence of soil is removed.
5.
Wait for 10 minutes (or the time recommended by the manufacturer of the detergent)
to allow the enzymes to activate.
6.
Wipe the aView clean using sterile gauze that has been moistened with RO/DI water.
Ensure all traces of the detergent are removed.
7.
Repeat steps 1 to 6.
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 minutes).
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 attention 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% Isopropyl
(alcohol) added to 20cc of purified water (PURW) (Alternatively, use EPA-registered hospital
disinfection wipes containing at least 70% isopropyl. Safety precautions and directions 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.
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