Ambu aScope Gastro Instrucciones De Uso página 6

5. Do not coil the insertion tube or umbilical cord to a diameter of less than
20 cm (8'') as this may damage the aScope Gastro.
6. Do not drop, bump, bend, twist or pull any portion of the aScope Gastro with
excessive force as the aScope Gastro may get damaged leading to failure in
functionality.
7. Do not use excessive force to advance an endotherapy accessory through the
working channel. Doing so may cause damage to the working channel of the
aScope Gastro.
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 aScope Gastro must be connected to the aBox 2 displaying unit. Please refer to the
aBox 2 IFU for more setup details.
aScope Gastro
Ambu® aScope™ Gastro
Sterile and single-use
Gastroscope
103 cm / 40.6''
2.1. Description of components and functions
The aScope Gastro 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 aBox 2
displaying unit. The aScope Gastro can be used with endotherapy accessories and
ancillary equipment for endoscopic procedures.
The components of the aScope Gastro 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 oesophageal sphincter.
6
Part Distal end
number outer diameter
9.9 mm
483001000
29.7 Fr
Working channel
inner diameter
2.8 mm
8.4 Fr