5 Safety Instructions
Device Combinations
Caution! When using devices in combinations, it is absolutely
essential that all the devices are connected to
permanently installed outlets of the same power
supply destined for medical use. Do not use any
outlets that can be moved (such as extension cables,
multiple outlets, etc.).
• Connect only devices of Safety Class I which meet the
standards EN 60950 or IEC 950 and are at least 1.50 m
away from the patient. Before starting the devices,
check the overall leakage currents in accordance with
EN 60601-1-1.
• Ensure that the leakage currents do not exceed the
following maximum values when operating the device
within the patient’s vicinity (* NC Normal Condition /
** SFC Single Fault Condition):
Caution! Connecting additional devices to the ICS (monitor,
CDM 3000, external printer) may cause leakage
current limits to be exceeded. Combine only devices
that comply with the standards EN 60950 or IEC 950
and that are set up outside of the patient environment
at a distance of at least 1.50 meters. For each device
combination, compliance with the overall leakage
currents must be established and documented before
putting it into operation. However, the test must be
repeated in accordance with legal requirements and
at least once a year.
NC* SFC**
Housing leakage current 0.1 mA 0.5 mA
Ground leakage current 0.5 mA 1.0 mA
Patient leakage current 0.01 mA = 0.05 mA =
0.1 mA ~ 0.5 mA ~
Patient auxiliary current 0.01 mA = 0.05 mA =
0.1 mA ~ 0.5 mA ~
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