SAFETY STANDARDS AND CLASSIFICATION OF THE SYSTEM
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SICAT JMT
⁺
Jaw Motion Analysis System
SAFETY STANDARDS AND CLASSIFICATION OF THE
SYSTEM
CLASSIFICATION PURSUANT TO APPENDIX IX OF THE
DIRECTIVE 93/42/EEC
The system is classified as a medical product of Class I with a measuring function.
SAFETY OF ELECTRICAL MEDICAL DEVICES
The device fulfils the requirements of the DIN EN 60601-1:2006 standard.
Classification corresponding to DIN EN 60601-1
Type BF
Protection class II
Continuous operation
Not suitable for use in an oxygen-enriched environment.
CONNECTION OF THE SICAT JMT
⁺
MEASUREMENT SYSTEM WITH
OTHER ELECTRICAL DEVICES
(also see DIN EN 60601-1:2006, section 16 Medical Electrical Systems)
CAUTION
The SICAT JMT
+
system may only be connected with other electrical devices if
they correspond with the requirements of DIN EN 60950 and/or DIN EN 60601-1,
or have been designated as compatible by SICAT GmbH & Co. KG.
CAUTION
When connecting several devices to a single measurement station, it is necessary
to ensure that no dangers can occur due to the accumulation of leakage
currents.
Devices with that the patient comes directly into contact, and which are used
together in a single medical electrical system, must comply in complete form
with all the requirements of DIN EN 60601-1:2006, section 11.
There is the risk of an electrical shock upon contact with devices that are not
earthed separately.
6
6.1
6.2
6.2.1
