Ambu aScope Gastro Instrucciones De Uso página 15

• Insert the endotherapy accessory through the biopsy valve into the working channel.
Hold the accessory approximately 4 cm (1.5") from the biopsy valve and advance it
slowly and straight towards the biopsy valve using short strokes while observing the
endoscopic image. Advance the accessory carefully through the working channel
until it exits the working channel outlet and can be seen on the monitor.
Withdrawal of endotherapy accessories
•
Ensure that the accessory is in a neutral position before withdrawing it from the
aScope Gastro through the biopsy valve.
•
If the accessory cannot be removed, retract the aScope Gastro as described in the
next paragraph while observing the endoscopic image.
Withdrawal of the aScope Gastro
•
Stop using the image magnification (zoom) function of the aBox 2.
• Aspirate accumulated air, blood, mucus or other debris by activating the suction valve.
• Move the Up/Down angulation lock to the "F" direction to release the angulation.
•
Turn the Right/Left 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 all tubes and tubing sets from the aScope Gastro connector.
Press the disconnection button and disconnect the aScope Gastro from the aBox 2.
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 tip.
Should any irregularities exist, immediately determine if any parts are missing and take
the necessary corrective action(s).
Disposal of the aScope Gastro
Discard the aScope Gastro including all packaging and the spare suction valve in
accordance with local guidelines for medical waste with electronic components.
Returning devices to Ambu
Should it be necessary to return an aScope Gastro to Ambu for evaluation, please
contact your representative at Ambu for instructions and/or guidance. To prevent
infection, it is strictly forbidden to ship contaminated medical devices. As a 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.
5. 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.
9
13
10
11
12
15