Ambu aScope 4 RhinoLaryngo Slim Instructions For Use Manual Download Page 5

Page: 5 / 97

4. Use of the endoscope

Optimize patient position and consider applying relevant anesthetics to minimize
patient discomfort.
Numbers in gray circles below refer to illustrations on page 2.

4.1. Preuse check of the endoscope

1.  Check that the pouch seal is intact before opening.  1a
2.  Make sure to remove the protective elements from the insertion cord.  1b
3.   Check that there are no impurities or damage on the product such as rough surfaces,

sharp edges or protrusions which may harm the patient.

Refer to the Instruction for Use for the compatible monitor for preparation and inspection
of the monitor. 2

4.2. Inspection of the Image

1. Plug in the endoscope into the corresponding connector on the compatible monitor.

Please ensure the colours are identical and be careful to align the arrows. 3

2. Verify that a live video image appears on the screen by pointing the distal end of the

endoscope towards an object, e.g. the palm of your hand. 4

3. Adjust the image preferences on the compatible monitor if necessary (please refer to the

monitor Instruction for Use).

4. If the object cannot be seen clearly, clean the tip.

4.3. Preparation of the endoscope

Carefully slide the bending control lever forwards and backwards to bend the bending section
as much as possible. Then slide the bending lever slowly to its neutral position. Confirm that
the bending section functions smoothly and correctly and returns to a neutral position.

4.4. Operating the endoscope

Holding the endoscope and manipulating the tip 6
The handle of the endoscope can be held in either hand. The hand that is not holding the
endoscope can be used to advance the insertion cord into the patient’s nose or mouth. Use
the thumb to move the control lever. The control lever is used to flex and extend the tip of the
endoscope in the vertical plan. Moving the control lever downward will make the tip bend
anteriorly (flexion). Moving it upward will make the tip bend posteriorly (extension). The
insertion cord should be held as straight as possible at all times in order to secure an optimal
tip bending angle.

Insertion of the endoscope 7
To ensure the lowest possible friction during insertion of the endoscope the insertion cord
may be lubricated with a medical grade lubricant. If the images of the endoscope becomes
unclear, clean the tip. When inserting the endoscope orally, it is recommended to use a
mouthpiece to protect the scope from being damaged.

Withdrawal of the endoscope 8
When withdrawing the endoscope, make sure that the control lever is in the neutral position.
Slowly withdraw the endoscope while watching the live image on the monitor.

4.5. After Use

Visual check 9
Inspect the endoscope for any evidence of damage on the bending section, lens, or insertion
cord. In case of corrective actions needed based on the inspection act according to local
hospital procedures.

Final steps 10
Disconnect the endoscope from the Ambu monitor and dispose the endoscope in accordance
with local guidelines for collection of infected medical devices with electronic components.

5. Technical Product Specifications
5.1. Standards Applied

The endoscope function 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 safety –

Collateral standard: Electromagnetic compatibility - Requirements for test.

– IEC 60601-2-18: Medical electrical equipment – Part 2-18: Particular requirements for the

safety of endoscopic equipment.

– ISO 8600-1: Optics and photonics - Medical endoscopes and endotherapy devices – Part 1:

General requirements.

– ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within

a risk management process.

5.2. Endoscope specifications