Baaske e-medic Manual - 4. Operation In A Network
8
Safety instructions for operation in the patient environment
In general the current valid national laws, standards and guidelines are to be complied
with. The Pro-Line II Computer may be used within the patient environment. In conjunction
with active medical products that were introduced according to the 93/42 EWG guidelines,
a new medical electrical system is created that must be re-evaluated. Peripheral devices
within the patient environment, such as printers or cameras, must also either comply with
the requirements of IEC 60601-1 and IEC60601-1-2 or be additionally equipped with a two-
stage protection for the patients. This additional protection can be ensured by the use of
isolating transformers or isolators in the connecting cable (see Point 2. “Patient environ-
ment” ). With non-compliance with the current regulations you are acting with gross negli-
gence and place the lives of your patients and those of uninvolved third parties in possible
danger. If in doubt contact our e-medic Support in order to create a safe environment for
you and your patients. If you need further support, such as specialist literature or training,
you can also contact our e-medic Support Team. We will be happy to help you further in an
uncomplicated and unbureaucratic manner.
//
3. Integration in a medical system
With the integration of the Pro-Line II Computer in a medical electrical system the requi-
rements of the valid version IEC 60601-1 and possibly the requirements of the medical
product guidelines 93/42 EWG (2007/47/EG) are to be complied with. The Pro-Line II PC
must only be electrically connected to and operated with products and devices that comply
with the requirements of the standards EN/IEC 60601-1 or EN/IEC 60950-1. Before the in-
tegration of the Pro-Line II PCs in a system, be sure to ask the manufacturer of the medical
system if this requirement for the operation with a PC is specified. If operation with a PC is
permitted keep strictly to the system manufacturers recommended performance values for
the PC unit. Connected data cables must be separately isolated, where appropriate, as well
as the connecting cable between the Pro-Line II PC and other possible connected devices.
//
4. Operation in a network
The Pro-Line II Computer may only be operated in a network that complies with the requi-
rements of EN 50173 resp. ISO/IEC 11801. We, as manufacturer of the e-medic computers,
will not be liable for transmission failures, data loss or electrical surges and short circuits in
your network structure that could occur due to non-standard installation. Only allow the
installation in your network to be carried out by the network administrator or a person
authorised by him.