Adverse Events; System Description; System Components - Ambu aScope Duodeno Manual Del Usuario

• Do not apply olive oil or products containing petroleum-based lubricants
(e.g. Vaseline®) to the endoscope. These products may cause deterioration of the
endoscope. Use only medical grade lubricants which are free of paraffins and silicone.
• If remote switches, the suction valve or the insufflation/rinsing valve are not returning
to the OFF position after being pressed, gently pull them upwards to return them to
OFF position.
Endoscopic Accessories
• Do not use damaged endoscopic accessories. Should any irregularities be
observed during use, take appropriate measures to avoid patient injury and/or
damage to equipment.

1.6. Adverse events

Potential adverse events in relation to Ambu Duodeno System (not exhaustive): Infection/
inflammation (including post-ERCP pancreatitis (PEP), cholangitis, cholecystitis, endocarditis
and sepsis), bleeding, perforation, thermal injuries, stent related adverse events,
cardiopulmonary adverse events, air embolism, anaesthesia related adverse events, nausea,
sore throat, abdominal pain and discomfort.

2. System Description

2.1. System Components

Ambu® aScope™ Duodeno
Sterile and single-use device
The aScope™ Duodeno is not available in all countries. For detailed information,
please contact your local sales office.
2.2. Compatible/Applicable Device
Ambu® aBox™ Duodeno
Reusable device
The aBox™ Duodeno is not available in all countries. For detailed information,
please contact your local sales office.
10
Part number Distal End Outer
Diameter ø
482001000 41.2 Fr
(13.7 mm)
Part number
485001000US (for US market)
485001000 (for non US markets)
Working channel
Inner Diameter ø
12.6 Fr
(4.2 mm)