Warnings And Cautions - Ambu aBox Duodeno Instrucciones De Uso

1.5. Warnings and Cautions

Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment. The manufacturer is not responsible for any damage to the system or patient
injury resulting from incorrect use.
WARNINGS
Indicate a potentially hazardous situation which, if not avoided, could result in death
or serious injury.
Preparation for Use
• Do not connect non-medical grade devices to the aBox™ Duodeno. Connection of
devices that are not medical grade (IEC 60601 conform) could have negative impact on
the safety of the system. Connect only medical grade equipment to the aBox™ Duodeno.
• Never use the aBox™ Duodeno if an abnormality is suspected. Damage or irregularity
in the device may compromise patient and/or user safety and may result in more
severe equipment damage.
• Keep fluids away from all electrical equipment. If fluids are spilled on or into the unit,
stop operation of the aBox™ Duodeno immediately and contact Ambu. Do not
prepare, inspect or use the aBox™ Duodeno with wet hands.
• In case of device failure or malfunction, always keep another aBox™ Duodeno in the
room ready for use.
• Never insert or spray anything into the ventilation grills of the aBox™ Duodeno. It can
cause an electric shock and/or fire.
• Always set the minimum required brightness. The brightness of the image on a
medical grade video monitor may differ from the actual brightness at the distal end
of an endoscope. Although the illumination light emitted from the endoscope's
distal end is required for endoscopic observation and treatment, it may also cause
alteration of living tissues such as protein denaturation of liver tissue and perforation
of the intestines by inappropriate use.
• Do not leave the endoscope illuminated before and after examination. Otherwise,
the LEDs could be redirected to the opened eyes of the sedated patient and can
cause retina burns. This product may interfere with other medical grade electronic
equipment used in combination with it.
• Before use, refer to the Appendix 1 to confirm the compatibility of this device with all
equipment to be used.
• Do not use this product in any place where it may be subject to strong
electromagnetic radiation (for example in the vicinity of a microwave therapeutic
device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone,
etc.). This may impair the performance of the product.
• If the endoscopic image dims during use, blood, mucus or debris may adhere to the
light guide on the distal end of the endoscope. Try to clear the LEDs by rinsing. If
image is still dimmed, carefully withdraw the endoscope from the patient and
remove the blood or mucus in order to obtain optimum illumination and to ensure
the safety of the examination. If you continue to use the endoscope in such a
condition, the distal end temperature may rise and cause mucosal burns. It may also
cause patient and/or operator injury.
• To display observation images, connect the output terminal of the aBox™ Duodeno
directly to a monitor. Do not make the connection via any ancillary equipment. Images
may disappear during observation depending on the condition of ancillary equipment.
Inspection of the aBox™ Duodeno
• Do not connect the power plug to the 2-pole power circuit with a 3-pole to 2-pole
adapter. To avoid the risk of electric shock, this equipment must only be connected
to a mains supply with protective earth.
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