Cautions
1.
Only use the aScope Gastro with medical electrical equipment that complies
with IEC 60601-1, and any applicable collateral and particular standards.
Failure to do so may lead to equipment damage.
2.
Prior to using any high frequency accessory device, check the compatibility with
the aScope Gastro. Always follow the instructions for use for the third party
device. Failure to do so may lead to equipment damage.
3.
Do not activate energized endoscopic accessories before the distal end
of the endoscopic accessory is in the field of view and is extended at an
appropriate distance from the distal end of the endosope as this may result
in aScope Gastro damage.
4.
Do not apply oil based lubrication in the working channel as this may increase
friction when inserting instruments.
5.
Do not coil the insertion tube or umbilical cord to a diameter of less than 20 cm
as this may damage the aScope Gastro.
6.
Excessive force – Do not drop, bump, bend, torque 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 the accessory device 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):
•
Air 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 has occurred,
please report it to the manufacturer and to your national authority.
2. Endoscope Description
aScope Gastro must be connected to the aBox 2 displaying unit. Please refer to
the aBox 2 Instructions for Use for more set-up details.
2.1. Description of Components
aScope Gastro
Ambu® aScope™ Gastro
Sterile and Single-Use
Gastroscope
103 cm / 40.6''
6
Part Number
Distal End
Outer Diameter
483001000
Working Channel
Inner Diameter
9.9 mm
2.8 mm