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10. Do not use excessive force when advancing, operating or withdrawing the aScope 3.
11. Patients should be adequately monitored at all times during use.
12. Always watch the live endoscopic image on the aView when advancing or withdrawing the
aScope 3, operating the bending section or suctioning. Failure to do so may harm the patient.
13. Do not use aScope 3 if the product sterilisation barrier or its packaging is damaged.
14. The distal end of the endoscope may get warm due to heating from the light emission part.
Avoid long periods of contact between the tip of the device and the mucosal membrane as
long, sustained contact with the mucosal membrane may cause mucosal injury.
15. Always make sure that any tube connected to the suction connector is connected to a
suction device.
16. When withdrawing the endoscope, the distal tip must be in neutral and non-deflected
position. Do not operate the bending lever, as this may result in injury to the patient
and/or damage to the aScope 3.
17. Do not advance or withdraw aScope 3, or operate the bending section, while
endoscopic accessories are protruding from the distal end of the working channel, as
this may result in injury to the patient.
18. 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
bending lever and never use excessive force, as this may result in injury to the patient
and/or damage to the aScope 3.
19. Always perform a visual check according to the instructions in this Instructions for Use
before placing the aScope 3 in a waste container.
20. Electronic equipment and the aScope 3 system may affect the normal function of each
other. If the aScope 3 system is used adjacent to or stacked with other equipment,
observe and verify normal operation of both the aScope 3 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.
21. The aScope 3 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.
22. 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.
23. To avoid risk of electric shock, the aScope 3 system must only be connected to a supply
mains with protective earth. To disconnect the aScope 3 system from mains remove the
mains plug from the wall outlet.
24. Always check compatibility with endotracheal tubes and double lumen tubes.
25. If any malfunction should occur during the endoscopic procedure, stop the procedure
immediately and withdraw the endoscope.
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 aScope 3.
3.
Be careful when handling the distal tip of the insertion cord 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 aScope 3 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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