8. The device should not be used if adequate supplemental oxygenation cannot be provided
to the patient during the procedure. Failure to comply could 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 applying suction. Failure to do so could 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 could cause patient injury.
11. Always check the compatibility of the scope with both airway management accessories
and endotherapy instruments. Failure to do so could 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
their 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, as this could result in patient injury.
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 could result in damage to mucosa or tissue.
15. Always watch the live endoscopic image on the Ambu display unit or external monitor
when advancing or withdrawing the endoscope, operating the bending section or
during suctioning. Failure to do so could result in damage to mucosa or tissue.
16. Make sure that the biopsy valve and its cap are properly attached prior to suctioning.
During manual suctioning, make sure that the syringe tip is fully inserted into the
working channel port/biopsy valve before applying 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 based on the patient's clinical characteristics. Failure to do
so could 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 could result in injury to
the patient and/or damage to the endoscope.
19. Do not damage the insertion portion during use. This could expose sharp surfaces that
may cause damage to the mucosa or this could 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 must 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 display unit, as this could 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 could 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 could result in injury to the patient
and/or damage to the endoscope.
24. Always perform a visual check as specified in these Instructions for Use before placing
the endoscope in a waste container to minimize the risk of post-procedure complications.
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