Ambu aScope Gastro Manual De Instrucciones página 6

1.6. Potential adverse events
Possible complications include (not exhaustive):
• Gas embolism
•
Gagging
•
Gastric-to-pulmonary aspiration
• Mucosal laceration
•
Mucosal bleeding
•
Perforation
• Peritonitis
1.7. General notes
If, during the use of this device or as a result of its use, a serious incident occurs, please report
it to the manufacturer and to your national authority�
2. Device description
The endoscope is to be connected to an Ambu displaying unit� For information about Ambu
displaying units, please refer to the Ambu displaying unit's Instructions for Use�
2.1. Device Parts
Pictogram
103 cm / 40.6''
Description of components and functions
The endoscope is a sterile and single-use gastroscope for use within the upper GI tract� It is
intended for left-handed use� The endoscope is inserted into the patient's upper GI tract
through the mouth and is powered by connection to the displaying unit� The endoscope can
be use with endotherapy accessories and ancillary equipment for endoscopic procedures�
The components of the endoscope are denoted in Figure 1 and are described within the
associated table underneath it� The working channel allows for the passage of endotherapy
accessories, instillation of fluids, and suction of fluids� The auxiliary water system allows the
instillation of fluids� The insufflation/rinsing fluid management system allows the instillation
of CO₂ to expand the GI lumen and rinsing of the lens� The optical module in the distal tip
consists of a camera housing which contains a camera and LED light sources� The user can
angulate the distal tip in multiple planes for visualization of the upper GI tract by turning the
control wheels to activate the bending section� The bending section can bend up to 210°
enabling a retroflexion to visualize the fundus and esophageal sphincter�
6
Finished Good
Name
Ambu® aScope™
Gastro
Ambu® aScope™
Gastro Large
Finished Distal end
Good outer
Number diameter
9�9 mm
483001000 0�39"
29�7 Fr
11�5 mm
582001000 0�45"
34�5 Fr
Working
Channel inner
diameter
2�8 mm
0�11"
8�4 Fr
4�2 mm
0�17"
12�6 Fr