Electromagnetic Compatibility; Impact Of Mobile And Portable Hf Communication Devices; Electrical Connections - Hologic Aquilex Gebrauchsanweisung

Electromagnetic Compatibility

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ESD (Electrostatic Discharge) precau-
tionary measures
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12 Electromagnetic Compatibility
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 ac-
cessories listed in Chapter Accessory List [} 60].
CAUTION!
Possible malfunctions
The Aquilex® Fluid Control System should not be used directly next to other devices
as this could result in malfunctions. The Aquilex® Fluid Control System was tested
for compliance with IEC 60601-1-2 as a standalone system. Therefore, do not stack
other devices on this equipment. If usage in the manner described above is never-
theless required, this equipment and the other devices should be monitored to
make sure they function properly.
Precautionary measures
Medical devices are subject to special safety and protective measures concerning
electromagnetic compatibility (hereafter abbreviated as EMC).
The device is to be used only for the purposes described in the Instructions for Use
and is intended for use in environments in Professional Healthcare Facility Environ-
ment. This applies even if individual requirements meet the conditions for deviat-
ing electromagnetic environments. During installation and commissioning as well
as during operation of the device, the compliance with the notes and instructions
for EMC must be strictly observed.
To ensure the basic safety and essential functionality in relation to electromagnetic
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 intervals indic-
ated in Chapter Maintenance Intervals [} 46] must also be observed.
This device complies with the electromagnetic compatibility (EMC) requirements
for medical electrical devices as defined by IEC 60601-1-2. The limits used in testing
provide a basic level of safety against typical electromagnetic interference likely to
occur in professional health care facilities. Nevertheless, it can happen that indi-
vidual performance features are no longer available or only to a limited extent due
to the presence of EM interference.

12.1 Impact of Mobile and Portable HF Communication Devices

The emission of high frequency energy by mobile communication devices may im-
pact the function of the electrical medical device. Operating such devices (e.g., cell
phones, GPS phones) in the proximity of the electrical medical device is prohibited.

12.2 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 implementing
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.
Employees have to be informed about and trained in ESD precautionary measures.