Standards And Regulations; Compliance With Regulations - Gendex VisualiX eHD User And Service Manual

Standards and
regulations
3.1

Compliance with regulations

The VisualiX system complies with the European Community Directive 93/42/EEC re-
garding medical devices and with the following standards:
• IEC 601.1 (1988), Amendment Nr. 1 (1991), Amendment Nr. 2 (1995)
• IEC 601.1.1 (2000)
• IEC 601.1.2 (2001)
• IEC 601.1.4 (1996), Amendment Nr. 1 (1999)
To ensure compliance, other parts of the system which are electrically wired (computer
and any other optional peripheral devices) must be located out of patient's reach (at a
distance of not less than 1.5 m from the patient) and comply with the UL/IEC/EN 60950
standard and EC directive 89/336.
In case other parts of the system are non medical devices, further considerations should
be done in accordance with IEC60601-1-1, under the responsibility of the installation
technician.
Compulsory declaration under European Directive 93/42 regarding Medical Devices: In ac-
cordance with the requirements of the CE mark, the user must notify the Ministry of Health of
any accidents involving the device and any alterations in the characteristics or performance
of the device, including inadequacy of the instructions provided, which could result in death
or damage to the health of the patient or user.
A copy of this notification must be promptly sent to the manufacturer or a representative
thereof to permit the manufacturer to comply with the requirements of the directive.
User and Service Manual
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Doc #4519 986 19041 - April 2005