Symbols
Indication
Date of Manufacture
Lot Number, Batch Code
Sterile device,
device was sterilized with
Ethylene-Oxide (EO).
Packaging level
ensuring sterility
Do not use if the package is
opened or damaged
Working length 124 cm/
48.8" of the aScope™
Duodeno
Legal Manufacturer
4. Preparation for Use
Numbers in gray circles below refer to illustrations on page 2. Before each procedure,
prepare and inspect a new endoscope as instructed below. Inspect other equipment to be
used with this endoscope as instructed in their respective instruction manuals. Should any
irregularity be observed after inspection, follow the instructions as described in section 8,
"Troubleshooting".
If this endoscope malfunctions, do not use it. Contact your Ambu sales representative for
further assistance.
4.1. Preparation and Inspection of the aScope™ Duodeno
Inspection of the Endoscope 1
•
Check that the pouch seal is intact.
•
Carefully peel of the peel pouch packaging of the aScope™ Duodeno packaging and
remove the protective elements from the handle and the distal end.
•
Carefully run your hand back and forth over the entire length of the insertion tube, including
the bending section and distal end, of the aScope™ Duodeno to make sure that there are no
impurities or damages on the endoscope, such as rough surfaces, sharp edges or protrusions
which may harm the patient. Make sure to use aseptic technique when performing the steps
above. Otherwise, the sterility of the product will be compromised. 1b
•
Inspect the distal end of the endoscope´s insertion section for scratches, cracks or other
irregularities. 1b
•
Turn the Up-Down and Right-Left control wheels in each direction until they stop and
return to neutral position. Confirm that the bending section functions smoothly and
correctly, that maximum angulation can be achieved and returned to neutral position. 1c
•
Operate the elevator control lever to confirm that the elevator can be operated smoothly
and correctly and can be returned to neutral position. 1d
14
Symbols
Rx Only
1a
Indication
Protect the packaged
product from moisture
Reference Number
Use by, Expiration Date
Refer to
Instructions for Use
Device not for reuse
Prescription Device
CE Mark
1b