Ambu aScope Gastro Manual De Instrucciones página 5

4� Patient leakage currents may be additive, when using energised endotherapy accessories�
Do not use energised endotherapy accessories which are not classified as "type CF" or
"type BF" applied parts according to IEC 60601-1, as that could lead to too high patient
leakage current�
5� Do not perform procedures with High Frequency (HF) endotherapy accessories if
flammable or explosive gases are present in the gastrointestinal tract as this may result
in serious injury to the patient�
6� Always observe the live endoscopic image when inserting, withdrawing, or operating
the endoscope� Failure to do so may result in patient injury, bleeding and/or perforation�
7� Ensure that the insufflator is not connected to the auxiliary water inlet as this may
cause over insufflation which can result in patient pain, bleeding, perforation and/or
gas embolism�
8� The distal tip of the endoscope may get warm due to heating from the LEDs� Avoid
long periods of contact between the distal tip of the endoscope and the mucosa as
sustained contact may cause tissue damage�
9� Do not insert or withdraw the endoscope if an endotherapy accessory is protruding
from the distal end of the working channel as this may result in injury to the patient�
10� If the biopsy valve is left uncapped and/or if the biopsy valve is damaged it can reduce
the efficacy of the endoscope's suction functionality, and may leak or spray patient
debris or fluids, posing a risk of infection� When the valve is uncapped, place a piece of
sterile gauze over it to prevent leakage�
11� Always use gauze to pull the endotherapy accessory through the biopsy valve as
patient debris or fluids may leak or spray, posing a risk of infection�
12� During the procedure always wear personal protective equipment (PPE) to protect
against contact with potentially infectious material� Failure to do so may cause
contamination potentially leading to infections�
13� Using HF endotherapy accessories with endoscope may disturb the image on the
displaying unit which may lead to patient injury� To reduce disturbance, try alternative
settings on the HF generator with lower peak voltages�
14� Portable Radio Frequency (RF) communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm (12'') to
any part of the endoscope and the displaying unit, including cables specified by the
manufacturer� Otherwise, degradation of the performance of this equipment could
result which could lead to patient injury�
CAUTIONS
1� Only use the endoscope with medical electrical equipment that complies with
IEC 60601, and any applicable collateral and/or particular standards� Failure to do
so may lead to equipment damage�
2� Prior to using any HF endotherapy accessory, check the compatibility with the
endoscope� Always follow the IFU of the third-party device� Failure to do so may lead
to equipment damage�
3� Do not activate energised endotherapy accessories before the distal end of the
endotherapy accessory is in the field of view and is extended at an appropriate distance
from the distal tip of the endoscope as this may result in endoscope damage�
4� Do not apply oil-based lubrication in the working channel as this may increase friction
when inserting endotherapy accessories�
5� Do not coil the insertion tube or umbilical cord to a diameter of less than 20 cm (8'') as
this may damage the endoscope�
6� Do not drop, bump, bend, twist or pull any portion of the endoscope with excessive
force as the endoscope 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 endoscope�
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