any irregularities exist, immediately determine if any parts are missing and take the neces
-
sary corrective action(s).
•
Disconnect the endoscope strain relief from the aBox™ Duodeno.
•
Discard the endoscope.
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In case of any adverse events please contact the manufacturer of the device or your local Ambu
distributor. In Europe the relevant country health agency or authority should also be informed.
Returning Devices to Ambu
Should it be necessary to send an aScope™ Duodeno to Ambu for evaluation, please inform your
representative at Ambu beforehand for instructions and/or guidance. To prevent infection, it is
strictly forbidden to ship contaminated medical devices. The medical device
aScope™ Duodeno
must be decontaminated on site before shipment to Ambu. Ambu reserve the right to return
contaminated medical devices to the sender.
Disposal of the aScope™ Duodeno
The Single-Use aScope™ Duodeno is considered medical waste after use and must be disposed of
in accordance with local guidelines for medical waste with electronic components. This is a single-
use device, so do not soak, rinse or sterilize as it may leave harmful residues or cause malfunction
of the device. The design and material used are not compatible with conventional cleaning and
sterilization procedures.
7.
Technical Data
All the following reported measurements (e.g. weight, dimensions) are average values. Therefore,
small variations may occur, which however will have no effect on the performance and/or safety
of the system.
7.1 aScope™ Duodeno
Endoscope Functions
Total Length
3100 mm
Insertion section
Working length
1240 mm
Insertion tube outer diameter
11.3 mm
Distal end outer diameter
13.7 mm
Bending section
Angulation
120° Up
90° Down
90° Left
110° Right
Illumination method
LED
Optical System
Field of view
Direction of view
130°
Backward side viewing 6°
Working channel inner diameter
Ø 12.6 Fr (4.2 mm)
7.2
Storage And Operation Environment Specifications
Transportation temperature
-5 - 40°C (41 - 104°F)
Storage temperature
10°C - 25°C
Operation temperature
10°C - 40°C
Relative humidity transportation, storage and
operation
30-85% relative
Atmospheric pressure
80-109 kPa (100kPa=1 Bar)11.6 - 15.8psi
600 - 818mmHg
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