en
4. To avoid risk of electric shock, only connect ancillary equipment, which is
approved as medical electrical equipment.
5. To avoid risk of electric shock, this equipment shall only be connected to a supply
mains with protective earth.
6. Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally.
7. To avoid patient injury due to loss of the live image during procedure, ensure to
correctly connect the power cord to an appropriate power source that will ensure
continuous power supply.
8. To avoid patient injury due to overheating of the displaying unit causing it to
suddenly shut down during procedure, do not cover the ventilation holes at the
bottom of the displaying unit.
9. To avoid electric shock and burns, do not touch any conductive metal parts of
the displaying unit while using high frequency tools (e.g. electrosurgical
equipment).
10. To ensure that images and videos are correctly exported to external systems and
to avoid potential misdiagnosis due to mixing-up of patient data, carefully check
that the patient identifiers are correct before starting, saving and exporting
the procedure.
CAUTIONS
1. To prevent damaging the displaying unit, always place the displaying unit on a hard
flat surface during use to avoid covering the ventilation holes at the bottom of the
displaying unit. Be aware that covering the ventilation holes can also lead to a high
surface temperature.
2. Using high frequency tools (e.g. electrosurgical equipment) in proximity of a
connected visualization device may affect the live image. This is not a malfunction.
Wait a few seconds for the image to return to normal.
3. Do not place any heavy objects on the top of the displaying unit when it is folded
flat, as this could damage the equipment and lead to malfunction or exposure of
electrical parts.
4. Use of accessories, transducers, and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
5. To avoid malfunction during procedure, do not use the displaying unit if it is
damaged in any way or if any part of the functional check described in section 7.1
fails.
6. To avoid malfunction of the equipment only use spare parts supplied by Ambu. Do
not modify the spare parts.
7. Cleaning and disinfection wipes shall be moist, but not dripping to ensure no
damage to internal electronics of the displaying unit.
8. If using wipes containing hypochlorite or citric acid during cleaning, ensure that all
residue is completely removed. Wipes containing hypochlorite or citric acid may
affect the screen's antireflective coating over time. You should limit the use of wipes
containing hypochlorite or citric acid to required cases only.
1.7. Potential Adverse Events
None known for the displaying unit.
1.8. General Notes
If, during the use of this device or as a result of its use, a serious incident has occurred, please
report it to the manufacturer and to your national authority.
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