Adverse Events - Ambu aBox Duodeno Instrucciones De Uso

• Do not place any object on the top of the aBox™ Duodeno. Otherwise, equipment
deformation and damage can result.
• Place the aBox™ Duodeno on a stable, level surface. Otherwise, the aBox™ Duodeno
may topple down or drop, and user or patient injury may occur or equipment
damage can result.
• If a trolley other than the mobile workstation is used, confirm that the trolley can
withstand the weight of the equipment installed on it.
• US federal law restricts this device for sale only by, or on the order of, a physician.
Care and Storage
• Do not clean the power cable socket, the connections and the AC mains power
inlet. Cleaning can deform or corrode the contacts, which could damage the
aBox™ Duodeno.
• Do not store the device in a location exposed to direct sunlight, X-rays, radio activity
or strong electromagnetic radiation (e.g. near microwave medical treatment
equipment, short-wave medical treatment equipment, MRI equipment, radio or
mobile phones). Otherwise, damage to the aBox™ Duodeno can occur.
• When disposing of this device or any of its components (such as fuses), follow all
applicable national and local laws and guidelines.
• Turn OFF all ancillary equipment before connecting to the aBox™ Duodeno and use
appropriate cables only. Otherwise, equipment damage or malfunction can result.
• Close the connector cover before you clean the aBox™ Duodeno. Do not open the
cover while cleaning the aBox™ Duodeno, otherwise fluid can penetrate the
connector and damage the device.
• Do not autoclave or sterilize the aBox™ Duodeno. This could lead to a damage of
the device.
• The cables should not be sharply bent, pulled, twisted or crushed. Cable damage
can result.
• Never apply excessive force to connectors. This could damage the connectors.
• Use this device only under the conditions described in "Transportation, storage and
operation environment Specifications" in section 10.2. Otherwise, improper
performance, compromised safety and/or equipment damage may result.
Accessories
• Do not attach anything other than the bottle holder to the aBox™ Duodeno.
Otherwise, equipment damage or deformation my result.
• Only place a bottle of sterile water into the bottle holder. Otherwise, the bottle
holder can be damaged.
• When the device is used with energized endoscopic devices, leakage current may be
additive. Use only endoscopic devices of type BF or CF. Check the compatibility of
the accessory/endoscopic device before use regarding any criteria for safe use.

1.6. Adverse Events

No known adverse events for the aBox Duodeno, please refer to the aScope Duodeno IFU for
ERCP related 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.
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