Ambu aScope 4 Broncho Serie Mode D'emploi page 5

15. Do not use the endoscope if the product sterilisation barrier or its packaging is damaged.
16. The distal tip 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 long, sustained contact with the mucosal membrane may cause mucosal injury.
17. Always make sure that any tube connected to the suction connector is connected to a
suction device.
18. When withdrawing the endoscope, the distal tip must be in neutral and non-deflected
position. Do not operate the control lever, as this may result in injury to the patient
and/or damage to the endoscope.
19. Do not advance or withdraw the endoscope, or operate the bending section, while
endoscopic accessories are protruding from the distal tip of the working channel, as
this may result in injury to the patient.
20. Always make sure that the bending section is in a straight position when inserting or
withdrawing an endoscopic accessory in 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.
21. Always perform a visual check according to the instructions in this Instructions for use
before placing the endoscope in a waste container.
22. Electronic equipment and the endoscope system may affect the normal function of
each other. If the system is used adjacent to or stacked with other equipment, observe
and verify normal operation of both the system and the other electronic equipment
prior to using it. It may be necessary to adopt procedures for mitigation, such as
reorientation or relocation of the equipment or shielding of the room in which it is used.
23. The endoscope consists of parts supplied by Ambu. These parts must only be replaced
by Ambu authorised parts. Failure to comply with this may result in patient injury.
24. Be careful to check whether the image on the screen is a live image or a recorded
image and verify that the orientation of the image is as expected.
25. To avoid risk of electric shock, the system must only be connected to a supply mains
with protective earth. To disconnect the system from mains remove the mains plug
from the wall outlet.
26. Always check compatibility with endotracheal tubes and double lumen tubes.
27. If any malfunction should occur during the endoscopic procedure, stop the procedure
immediately and withdraw the endoscope.
28. Insert the syringe completely into the working channel port before instilling fluid.
Failure to do so may result in the fluid spilling from the working channel port.
CAUTIONS
1. Have a suitable backup system readily available for immediate use so the procedure
can be continued if a malfunction should occur.
2. Be careful not to damage the insertion cord or distal tip when using sharp devices
such as needles in combination with the endoscope.
3. Be careful when handling the distal tip and do not allow it to strike other objects,
as this may result in damage to the equipment. The lens surface of the distal tip is
fragile and visual distortion may occur.
4. Do not exert excessive force on the bending section as this may result in damage to
the equipment. Examples of inappropriate handling of the bending section include:
– Manual twisting.
– Operating it inside an ETT or in any other case where resistance is felt.
– Inserting it into a preshaped tube or a tracheostomy tube with the bending
direction not aligned with the curve of the tube.
5. US federal law restricts these devices for sale only by, or on the order of, a physician.
6. Keep the endoscope handle dry during preparation, use and storage.
7. Do not use a knife or other sharp instrument to open the pouch or cardboard box.
8. Secure the tubing properly on the suction connector before suction is applied.
9. If needed remove secretion or blood from the airway before and during the procedure.
The suction function of any appropriate suction device can be used for this purpose.
10. Apply a vacuum of 85 kPa (638 mmHg) or less when suctioning. Applying too large a
vacuum may make it difficult to terminate suctioning.
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