Precautions - Hologic Aquilex Instructions D'utilisation

Purpose
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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!
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!
Incorrect determination of fluid deficit
Always use the hooks of the bag scale to hang the fluid bags to ensure an accurate
determination of the fluid deficit. In addition, leave the empty fluid bags hanging
on the bag scale until the end of surgery.
WARNING!
Filter
The vacuum tube with integrated filter is designed for max. 30 days. The vacuum
tube may not be sterilized. Replace the vacuum tube sooner if it is obviously con-
taminated. The filter prevents body fluids from entering the interior of the device.

3.1.2 Precautions

CAUTION!
Federal Law (only for U.S. market)
Federal law restricts this device to sale by or on the order of a physician.
CAUTION!
Indoor climate
Before switching on the device, sufficient time must have passed to adjust to the
indoor climate.
CAUTION!
Device setup
Device should be positioned outside of the sterile area in such a way that
• it can be easily disconnected,
• it is easy to use and switch off and on,
• it allows an easy monitoring of the display values, device functions, and access
to the control elements.