Ambu aScope 5 Broncho 4.2 Mode D'emploi page 5

8. The device should not be used if adequate supplemental oxygenation cannot be provided
to the patient during the procedure. Failure to comply may result in patient desaturation.
9. Always make sure that any tube connected to the suction connector on the scope is
connected to a suction device. Secure the tubing properly on the suction connector
before suction is applied. Failure to do so may result in patient or user injury.
10. Apply a maximum vacuum of 85 kPa (638 mmHg) when suctioning. Applying too large
a vacuum may make it difficult to interrupt suctioning and may cause patient injury.
11. Always check compatibility of the scope with both airway management accessories
and endotherapy instruments. Failure to do so may result in patient injury.
12. For non-intubated patients a mouthpiece should be used when inserting the
endoscope orally to prevent the patient from biting the insertion cord and potentially
damaging her/his teeth.
13. The shape and size of the nasal cavity and its suitability for transnasal insertion may
vary from patient to patient. Individual differences in the shapes and sizes of the
patients' nasal lumens, as well as their receptivity to transnasal insertion, must be
considered prior to the procedure. Never use force during insertion or withdrawal of
the endoscope transnasally because patient injury may occur.
14. Verify that the orientation of the image is as expected and be careful to check whether
the image on the screen is a live image or a recorded image. Failure to do so will
increase the difficulty of navigation and may result in damage to mucosa or tissue.
15. Always watch the live endoscopic image on the Ambu displaying unit or external
monitor when advancing or withdrawing the endoscope, operating the bending
section or during suctioning. Failure to do so may result in damage to mucosa or tissue.
16. Ensure the biopsy valve and its cap are properly attached prior to suction. During
manual suction, ensure that the syringe tip is fully inserted into the working channel
port/biopsy valve prior to suction. Failure to do so may expose unprotected users to
the risk of infection.
17. The endoscope images must not be used as an independent means of diagnosis for
any clinical finding. Healthcare professionals must interpret and substantiate any
finding by other means and in the light of the patient's clinical characteristics. Failure
to do so may result in delayed, incomplete, or inadequate diagnosis.
18. Always make sure that the bending section is in a straight position when inserting or
withdrawing an endotherapy instrument into or out of the working channel. Do not
operate the control lever and never use excessive force, as this may result in injury to
the patient and/or damage to the endoscope.
19. Do not damage the insertion portion during use. This may expose sharp surfaces that
may cause damage to the mucosa or this may result in parts of the product being left
inside the patient. Particular care should be taken to avoid damaging the insertion
portion when using the endoscope with endotherapy instruments.
20. Bronchoscopists and assistants shall be familiar with the adequate personal protective
equipment for bronchoscopy procedures in order to avoid contamination of staff.
21. Do not activate an endotherapy instrument in the endoscope before the instrument's
distal end can be seen in the image on the displaying unit, as this can lead to patient
injury or damage the endoscope.
22. The distal end of the endoscope may get warm due to heating from the light emission
part. Avoid long periods of contact between the distal tip and the mucosal membrane
as this may cause injury to mucosa.
23. When inserting or withdrawing the endoscope, the distal tip must be in a non-
deflected position. Do not operate the control lever, as this may result in injury to the
patient and/or damage to the endoscope.
24. Always perform a visual check according to the instructions in this Instructions for use
before placing the endoscope in a waste container to minimize the risk of post
procedure complications.
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