Guidelines And Manufacturer's Statement - Electromagnetic Compatibility; Electrical Connections - Hologic Aquilex Instrucciones De Uso

Guidelines and Manufacturer's Statement - Electromagnetic Compatibility

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Precautionary measures
ESD (Electrostatic Discharge) precautionary
measures
44
12 Guidelines and Manufacturer's Statement - Electromag-
netic Compatibility
Medical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
This device is to be used only for the purposes described in the manual and has
to be installed, set up, and operated in compliance with the EMC notes and in-
structions.
WARNING!
The Aquilex Fluid Control System should not be used directly next to other devic-
es as this could result in malfunctions. The Aquilex Fluid Control System was test-
ed for compliance with IEC 60601-1-2 as a stand alone system. Therefore, do not
stack other devices (e.g. MyoSure® Control Unit) on the system or the Irrigation
Pump Unit. In particular, do not place any other device than the AQL-100P on the
trays of the AQL-100CBS. If usage in the manner described above is nevertheless
required, this system and the other devices should be monitored to make sure
they function properly.
CAUTION!
Accessories
To ensure compliance with the requirements of IEC 60601-1-2 in the current ver-
sion, the device Aquilex Fluid Control System must be used only with the acces-
sories listed in chapter 13, Accessory List.
To ensure the basic safety and essential functionality in relation to electromag-
netic interference over the life of the device, the device must be restarted after
24 hours so that a diagnostic self-test can be performed. The maintenance inter-
vals indicated in Chapter 8.2 must also be observed.
12.1

Electrical Connections

Do not touch electrical connections identified with this warning label. Do not es-
tablish a connection between these plugs and sockets without first implement-
ing precautionary ESD (electrostatic discharge) measures.
The following are ESD precautionary measures:
• Apply potential equalization (PE), if available on your equipment, to all devices
to be connected.
• Use only the listed equipment and accessories.
Hospital employees should be informed about and trained in ESD precautionary
measures.