Safety
4-24 Versana Essential – User Guide
5759238-100 English
Rev. 2
Peripherals used in the patient environment (continued)
General precautions for installing an alternate on-board device
would include:
1. The added device(s) must have appropriate safety standard
conformance and CE Marking.
2. The total power consumption of the added devices, which
connect to the Versana Essential and are used
simultaneously, must be less than or equal to the rated
supply of the Versana Essential.
3. There must be adequate heat dissipation and ventilation to
prevent overheating of the device.
4. There must be adequate mechanical mounting of the device
and stability of the combination.
5. Risk and leakage current of the combination must comply
with IEC/EN 60601-1.
6. Electromagnetic emissions and immunity of the combination
must conform to IEC/EN 60601-1-2.
General precautions for installing an alternate on-board device
would include:
1. The added device(s) must have appropriate safety standard
conformance and CE Marking.
2. The added device(s) must be used for their intended
purpose having a compatible interface.
3. Signal or mains isolation devices and additional protective
earth may be needed to assure compliance with IEC/EN
60601-1.
Peripheral used in the non-patient environment
The Versana Essential has also been verified for compatibility,
and compliance for connection to a USB HDD/USB memory via
the system USB port, provided the USB HDD/USB memory are
IEC/ EN 60950 compliant.
The connection of equipment or transmission networks other
than as specified in the user instructions can result in an
electric shock hazard or equipment malfunction. Substitute or
alternate equipment and connections requires verification of
compatibility and conformity to IEC/EN 60601-1 by the installer.
Equipment modifications and possible resulting malfunctions
and electromagnetic interference are the responsibility of the
owner.
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