The JMA-Optic system may only be coupled with other electrical devices
if these conform to the provisions of DIN EN 60950 or DIN EN 60601-1
or the manufacturer has confirmed their compatibility.
When coupling several devices to one measuring station, please note
that no danger through summation of leakage currents can occur.
Devices that are in direct contact with the patient and that are com-
monly used in a medical electrical system, as a whole have to fulfill all
requirements of DIN EN 60601-1:2013 section 16.
There is a potential danger of electric shock when touching devices that
are not grounded separately.
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JMA-Optic
9 Safety standards and system classification
9.1. 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
.
9.2. Safety of medical electrical devices
The device fulfills the requirements of the standard DIN EN 60601-1:2013.
Classification according to DIN EN 60601-1
■
Type BF
■
Safety class II
■
Steady state conditions
■
Unsuitable for use in an oxygen-enriched atmosphere
9.2.1. Connecting the system to other electircal devices
(also refer to DIN EN 60601-1:2013 section 16 medical electrical systems)
9.2.2. Environment of the patient
In practice, as an empirical value a clearance of 1.5 m from the patient has proven effective
for the determination of the patient environment.
Содержание JMAOptic
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