Regulatory Requirements - ACteon SOPROCARE Manuel D'utilisation

E N G L I S H

REGULATORY REQUIREMENTS

Y RE
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 the SOPRO 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.
The SOPRO camera is designed and tested to be used in a home environment, class B Group 1, according to CISPR11 standard.
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SOPROCARE • User's manual