Ambu aScope Gastro Instrucciones De Uso 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 aScope Gastro. 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 overinsufflation which can result in patient pain, bleeding,
perforation and/or gas embolism.
8. The distal tip of the aScope Gastro may get warm due to heating from the LEDs.
Avoid long periods of contact between the distal tip of the aScope Gastro and
the mucosa as sustained contact may cause tissue damage.
9. Do not insert or withdraw the aScope Gastro if 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 aScope Gastro'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 aScope Gastro 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 aScope Gastro 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 aScope Gastro 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
aScope Gastro. 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 aScope Gastro
damage.
4. Do not apply oil-based lubrication in the working channel as this may increase
friction when inserting endotherapy accessories.
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