Electromagnetic Compatibility; Electrical Connections; Guidance And Manufacturer's Declaration - Electromagnetic Emissions - Hologic Aquilex Instructions D'utilisation

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 [} 54].
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 [} 41] 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 Electrical Connections

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.
12.2 Guidance and Manufacturer's Declaration - Electromagnetic
Emissions
The device Aquilex® Fluid Control System is intended for use in an environment as
described below. The user/operator of the device Aquilex® Fluid Control System
should make sure the device is operated within such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Compliance
Group 1
Class B
Class A
Complies
Electromagnetic Compatibility
ESD (Electrostatic Discharge)
precautionary measures
Electromagnetic environment - guidance
The device Aquilex® Fluid Control System uses RF energy
solely for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in
nearby electronic equipment.
The device Aquilex® Fluid Control System is suitable for
use in all establishments, other than public establish-
ments and those directly connected to the public mains
network that supplies buildings used for public purposes.
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