Regulatory Requirements - ACTEON SOPROLIFE Manual De Usuario

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REGULATORY REQUIREMENTS

4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
This product was designed and manufactured by a company having an authorized quality system. It meets the
European directive 93/42/EEC requirements relative to medical devices. Therefore, it particularly meets
electrical safety and electromagnetic compatibility standards (IEC) (CEM).
4.2. ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (CEM) is the ability of electronic device elements to correctly interact in an
electronic environment. Although SOPROLIFE system was designed according to this compatibility and complies
with the electromagnetic interference thresholds established by the regulatory agency, there is no guarantee
about interference likely to occur on a particular installation. If the device generates interference with radio
communication services (which can be determined by switching it off and on), it is recommended to try to
correct this phenomenon by taking whole or part of the following measures:
• Change the receiving antenna orientation
• Reposition the product according to the receiver.
• Take the computer away from the receiver.
SOPROLIFE is designed and tested to be used in a home environment, class B Group 1, according to CISPR11
standard.
4.3. MEDICAL DEVICE VIGILANCE
As with any medical device, this device is subjected to medical device vigilance dispositions; any serious
dysfunction should then be the subject of a description to the competent authorities and to the manufacturer
as soon as possible and as precisely as possible.
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