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22.3
EMC and Essential Performance
22.4
Electromagnetic Compatibility and Interference
Guidance
The following environmental conditions related to electrostatic sensitive
components (ESD standards) must be observed:
Floors coated with wood, tiles or concrete
Relative humidity of at least 30%
If it is not possible to guarantee this environment, the following additional
precautions must be taken:
Use of anti-static equipment
Preliminary user discharge (explained below)
Anti-static clothing
The best precaution is preliminary user discharge on a grounded metal object
such as a rail, a pole or a metal part located at the rear of the Agilia pump.
For maintenance operation performed on the Agilia pump, place the device on
a conductive working surface, and wear a special ESD conductive wristband.
In standard operating conditions (see section 1.8, page 12), the essential
performance of the Agilia pump is defined in section 14.1, page 92.
In the event of electromagnetic disturbances above the limits defined in the
applicable EMC standards, if the essential performance is lost or degraded, the
consequences for the patient are: overdose, underdose, delay of therapy,
electric shock.
It is the responsibility of the customer or user to check the equipment before use
as described in section 10, page 80, and to consider the EMC guidance of
The Agilia pump has been tested in accordance with the electromagnetic
compatibility standards applicable to medical devices. Its immunity is designed
to ensure correct operation. Limitation of the emitted radiation avoids
undesirable interference with other equipment.
AgiliaSP MC is classified as a Class B device according to CISPR 11 emitted
radiation.
