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4.2. Inspection of the image
1.
Plug in the endoscope cable connector into the corresponding connector on the
compatible displaying unit. 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 tip of the
endoscope towards an object, e.g. the palm of your hand. 4
3.
Adjust the image preferences on the compatible displaying unit if necessary (please refer
to the displaying unit (Instruction for use).
4.
If the object cannot be seen clearly, clean the tip.
4.3. Preparation of the endoscope
Carefully slide the control lever forwards and backwards to bend the bending section as much
as possible. Then slide the control lever slowly to its neutral position. Confirm that the bending
section functions smoothly and correctly and returns to a neutral position. 5
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 distal tip
of the endoscope in the vertical plan. Moving the control lever downward will make the distal
tip bend anteriorly (flexion). Moving it upward will make the distal tip bend posteriorly
(extension). The insertion cord should be held as straight as possible at all times in order to
secure an optimal distal 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 distal 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 displaying unit.
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.
Disconnect 10
Disconnect the endoscope from the Ambu displaying.
Disposal 11
Dispose of the endoscope, which is a single-use device . The endoscope is considered
contaminated after use and must be disposed of 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:
– EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
– EN 60601-2-18 Medical electrical equipment - Part 2-18 Particular requirements for the basic
safety and essential performance of endoscopic equipment.
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