Keratron™ Nova
Manual for installation and use
OPTIKON 2000
Cod. 161601EN
3-4
2016-12-28 Rev.B
The Keratron™ Nova, when mounted on a LAF, constitutes an electro medical
system. It is responsibility of the organization installing the system (in general the
hospital) or operator, to verify the whole system compliance with the IEC 60601-1.
Make sure, in particular, that the system leakage currents are less than the
maximum permissible value and adopt, if necessary, an isolation transformer.
Keratron™ Nova system operates in conjunction with a PC and its peripherals or
a router (or similar) via the Ethernet connection. The system (PC including
monitor and/or any peripherals) to be connected to the device must comply with
EN 60601-1.
•
If the device is an apparatus connected to an appliance which one is not sure
of its compliance to EN 60601-1 one is exposed to:
under normal operating conditions, to the risk of an excessive leakage current
•
towards the ground of the entire system due to the device leakage
current does not conform;
•
in conditions of a single failure (interruption of the common protection
ground), to the risk of an excessive dispersion current of the casing in
consequence of the non-compliant device leakage current.
To avoid these risks, with a PC which does not comply with EN 60601-1 or
with a connection to a router, it is recommended to use an isolation
transformer set between the PC (including the monitor and any additional
peripherals) and the power socket on the wall.
The PC with the related devices and/or router must be positioned outside of the
patient area (at least 1.0 meters). In the patient area you may position only the
Keratron™ Nova topographer and the slit lamp or the movable base with the
Optikon joystick.
•
Do not use multiple portable power outlets or extension cords to power the
apparatus.
•
In a possible use in the operating room, if multiple devices are connected to
the patient, or these are interconnected, have qualified personnel evaluate
