After Use; Standards Applied - Ambu aScope Gastro Instrucciones De Uso

Withdrawal of Endoscopic Accessories
• Ensure that the accessory/tool is in a neutral position and withdraw the accessory
from the aScope Gastro through the biopsy valve.
•
If the accessory cannot be removed retract the aScope Gastro while observing
the endoscopic image.
Withdrawal of the aScope Gastro 9
•
Stop using the image magnification (zoom) function of the aBox 2.
•
Aspirate accumulated air, blood, mucus or other debris by depressing the suction valve.
•
Move the Up/Down angulation lock to the "F" direction to release the angulation.
•
Turn the Left/Right angulation lock to the "F" direction to release the angulation.
•
Carefully withdraw the aScope Gastro while observing the endoscopic image.
•
Remove mouthpiece from the patient´s mouth.

4.6. After Use

Detach the tubings from the Insufflation/Water, Suction and the Auxiliary Water systems
from the aScope Gastro Connector. 10
Press the Disconnection Button and disconnect the aScope Gastro from the aBox 2. 11
Check the aScope Gastro for any missing parts, evidence of damage, cuts, holes, sagging,
or other irregularities on the bending and insertion section including the distal end of
the aScope Gastro. 12
Should any irregularities exist, immediately determine if any parts are missing and take
the necessary corrective action(s).
Discard the aScope Gastro in accordance with local guidelines for medical waste with
electronic components. 13
Returning Devices to Ambu
Should it be necessary to return an aScope Gastro to Ambu for evaluation, please
contact your representative at Ambu beforehand for instructions and/or guidance.
To prevent infection, it is strictly forbidden to ship contaminated medical devices.
The medical device aScope Gastro must be decontaminated on site prior to shipment to
Ambu. Ambu reserves the right to return contaminated medical devices to the sender.
Disposal of the aScope Gastro
The aScope Gastro is for single-use only.
Do not soak, rinse or sterilize as it may leave harmful residues or cause malfunction of
the aScope Gastro. The design and material used are not compatible with conventional
cleaning and sterilization procedures.
Discard all the packaging including the spare suction valve after the procedure.
5. Technical Device Specifications

5.1. Standards Applied

The aScope Gastro conforms with:
– 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 basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests.
– IEC 60601-2-18 Medical electrical equipment – Part 2-18: Particular requirements for the
basic safety and essential performance of endoscopic equipment.
– ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing
within a risk management process.
– ISO 8600-1 Endoscopes – Medical endoscopes and endotherapy devices – Part 1:
General requirements.
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