Safety Instructions For Operation In The Patient Environment - Baaske Medical e-medic Silence XT-M Handbuch

Depending on the medical purpose of the overall system it may also be necessary
to install a so called galvanic separation between an active medical product and a
computer system for both as well as for Computers to comply with the requirements
of EN / IEC 60601-1. Galvanic separation isolates the wanted signal of the respective
PC interface, such as network (Ethernet), USB or DVI interfaces.
The following table shows some of our recommended and tested isolators which can
be sourced through your e-medic™ dealer. Data lines that may possibly be connected,
e.g. network and ISDN cables, must also be isolated.
Connecting cable
type:
USB
Seriell RS-232
LAN-Netzwork
BNC/S-VHS
DVI

Safety instructions for operation in the patient environment

In general the current valid national laws, standards and guidelines are to be com-
plied with. The e-medic™ computer may be used within the patient environment.
In conjunction with active medical products that were introduced according to the
Regulation (EU) 2017/745 on medical devices, 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 EN
/ IEC 60601-1 and EN / IEC 60601-1-2 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 envi-
ronment"). In non-compliance with the current regulations you are acting with gross
negligence and place the lives of your patients and those of uninvolved third parties
Model name:
STD 1.0 LWL
RS232 Isolator STD 2.5KV B 9Pin
MI 1005 / MI 2005
MED Video Isolator 1, 2, 4
DVI-Isolator STD1, STD2, STD4
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