SOCT Copernicus PLUS - Service Manual
3. Safety standards
The SOCT Copernicus+ system complies with all requirements of the directive 93/42/EEC (MDD -
Medical Devices Directive)
The SOCT Copernicus+ is Type B applied parts, class I protection against electric shock.
Usually SOCT Copernicus+ is a part of larger Medical System, which consists of many other medical
and non- medical devices. Medical system in general and all its components have to fulfill
requirements of IEC 60601-1 standard.
In order to comply with the IEC 60601-1 standard all non Medical Devices must be connected to
the Separating Transformer which is supplied with the SOCT Copernicus+. By connecting the
devices to the Separating Transformer leakage current is reduced to a level which is in line with the
IEC standard.
The Separating Transformer fulfils requirements of IEC 60601-1 standard for medical devices which
has not application part.
The Separating Transformer supply the power for non medical devices connected to electric not
grounded mains in room.
The Separating Transformer can be installed in patient environment in accordance with IEC 60601-
1 standard.
SOCT Copernicus+ is connected to computer using USB cable. This cable is electrically
separated using optocouplers. It provides additional safety, when computer and SOCT
Copernicus+ device are connected to two different power supply sockets with different ground
potentials. Video signal and synchronization signal are transferred to computer using coaxial
cables, which are electrically separated from SOCT Copernicus+ device providing even more
safe solution.
No user serviceable parts inside SOCT Copernicus+ device. Light source is included inside device.
Removing of covers can be done only by Manufacturer or Authorized Personnel.
The maximum power of light radiation available outside covers
Is less than 1020(±3) microwatts providing safe operation of the device.
Objective lens is output of light.
SOCT Copernicus + system can be connected only to power supply socket equipped with
properly connected grounding pin.
Please note that only the PC, monitor and printer are to be connected to the Isolating Transformer.
Connecting non medical devices in other way than in point 7.3 Device connection diagram can lead
to electric shock or damage of the devices.
Prohibit connect any non medical or medical devices which are not including with SOCT
Copernicus+ system to the Separating Transformer e.g. lamp, vacuum cleaner etc.
The SOCT Copernicus + must not be connected to the transformer, but directly to power supply
socket equipped with properly connected grounding pin.
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