Maintenance; Disposal; Technical Product Specifications; Standards Applied - Ambu aBox 2 Instrucciones De Uso

Procedure 3 – Enzymatic detergent cleaning and alcohol disinfection
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, external side of rubber covers, screen, external casing of
the monitor with the moist gauze. Avoid getting the displaying unit wet to prevent
damaging internal electronic components.
4. Wait for 10 minutes (or the time recommended by the manufacturer of the detergent)
to allow the enzymes to activate.
5. Wipe the displaying unit clean using sterile gauze that has been moistened with
RO/DI water. Ensure all traces of the detergent are removed.
6. Repeat steps 1 to 5.
Disinfecting: Wipe the surfaces of the displaying unit 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 displaying unit. Pay close attention to the button, external side of
rubber covers, screen, external casing and slots and gaps on the displaying unit. Use a
sterile cotton swab for these areas. Solution: Isopropyl (alcohol) 95 %; Concentration: 70 –
80 %; Preparation: 80 cc 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.
Note: After cleaning and disinfection, the displaying unit must be submitted to the pre-check
procedure in chapter 10. The specified cleaning and disinfection procedures show compliance
with the AAMI TIR12 and AAMI TIR30 guidelines.

15. Maintenance

The displaying unit shall be subject to preventive inspection prior to use according to
chapter 10 and shall be cleaned and disinfected according to chapter 14.
No other preventive inspection, maintenance or calibration activities are required for the
displaying unit.

16. Disposal

At the end of product life, clean and disinfect the displaying unit (see chapter 14).
Before disposing of the displaying unit, it is advised to follow these steps to erase all data:
• Log in as Administrator.
• Delete all files stored in the displaying unit from the Archive - Select all folders and press
the bin .
• Delete Wi-Fi network and password though the Settings – Setup – Network setup menu.
• Delete DICOM network via the Settings – Setup – DICOM setup menu.
• Delete all Advanced Users from the Settings – User profiles menu.
•
Then, dispose of the displaying unit in accordance with local guidelines for electrical and
electronic waste.

17. Technical Product Specifications

17.1. Standards applied

The displaying unit function conforms with the following standards:
•
IEC 60601-1 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.
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