ENGLISH
PSPIX² • User manual
12
REGULATORY STATEMENT
4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
The PSPIX system has been designed and manufactured by SOPRO, a company which is certifi ed with
the ISO13485 Quality Control System Standard. It complies with the essential requirements of European
Directive 93/42/EEC concerning medical devices. It therefore particularly complies with the IEC standards
on electrical safety and Electromagnetic Compatibility (EMC).
4.2. ELECTROMAGNETIC INTERFACES AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (EMC) covers the ability of the components of electronic appliances to
correctly interact in an electronic environment. Although the PSPIX system has been designed with this
compatibility and respects the thresholds of electromagnetic interferences put in place by the regulatory
body, no guarantee is given regarding the interferences likely to be produced at a given facility. If the PSPIX
system generates interference with radio communication services (which can be checked by switching it on
and then switching it off again) we advise that you avoid this by taking all or some of the following steps:
• Change the position of the receiving antenna
• Reposition the PSPIX system in relation to the receiver.
• Keep the computer at a good distance from the receiver.
The PSPIX system is designed and tested to be used in a domestic class B and group 1 environment in
compliance with standard CISPR11.
CAUTION:
The internal components of the PSPIX system may be sensitive to electrostatic discharges once the IP
insertion part has been removed. Do not insert any metallic object or any source likely to cause an
electrostatic discharge into the device.This can cause a PSPIX system malfunction.
4.3. MONITORING SYSTEMS FOR MEDICAL DEVICES
As with any medical device, the PSPIX system is equipped with monitoring systems for medical devices. Any
serious malfunction must be reported both to the competent authorities and to the manufacturer as soon as
and with as much detail as possible.
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