Hysterosocopy Specific Warnings - Hologic Aquilex Fluid Control System Instrucciones De Uso Y Manual Del Operador

Purpose
en
WARNING!
Electromagnetic emissions
Electromagnetic emissions may increase and rise above the permissible limits if
other equipment (e.g. MyoSure® Control Unit) is stacked onto or placed directly
next to the Aquilex Fluid Control System. The user is responsible for monitoring the
devices to make sure they function properly.
WARNING!
Portable HF communication equipment
Portable HF communication equipment can affect the performance characteristics
of the device Aquilex® Fluid Control System. Such equipment must therefore com-
ply with a minimum distance of 30 cm (regardless of all calculations) from the
device Aquilex® Fluid Control System, its components and cables.
WARNING!
If the Aquilex® Fluid Control System is configured as part of a ME SYSTEM, the en-
tire ME SYSTEM should be tested for compliance with IEC 60601-1-1, and any
equipment used with the Aquilex® Fluid Control System should be Type BF.
WARNING!
If the leakage current of the configured ME SYSTEM exceeds the limits of IEC
60601-1-1, install an appropriately rated UL 2601-1/IEC 60601-1 approved isolation
transformer and retest the system.
WARNING!
Touching containers and their holders
Touching the containers and their holders as well as vibrations of the balancing
system should be avoided during surgery to prevent false detection of the con-
tainer change and not negatively affect the accuracy of the deficit calculation.

3.1.2 Hysterosocopy Specific Warnings

WARNING!
Distension media
When performing monopolar hysteroscopic electrosurgery, the distension medium
must be electrically non-conductive. Examples include glycine, sorbitol and man-
nitol. Isotonic saline irrigation fluids may only be used when performing bipolar
electrosurgical resective procedures.
WARNING!
Pressure
The pressure should be kept as low as possible to allow for a sufficient intrauterine
distention and to reduce the forces that could allow fluid, ambient air, and/or gas
to enter the circulatory system.
WARNING!
Risk of intravasation
If the intrauterine pressure does not react to an increase in the pressure setting
during the procedure, a perforation of the uterine cavity might be the cause. This
results in an increased risk of intravasation. Examine the uterine cavity for injuries.
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