safety, warnings, precautions, prohibitions
file: n:\article\cos14310m5-v1_06hpc-en\20120215_cos14310m5-v1.06hpc-en_manual_h-p-cosmos_running_machine.doc
© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 23 of 213
[4.E4]
Connection of units installed outside medically utilized locations
If units installed outside medically utilized locations (e. g. external printer, host computer etc.) are connected to an
h/p/cosmos unit installed in a medically utilized location the VDE 0750 regulations must be observed. Connection
only via …
1. Optical fibre or optocoupler (4 kV checked and approved) or …
2. Protective isolation via insulation transformer according to IEC 60601-1, appendix k. These units are also to be
connected to the equipotent conductor.
Due to the increased safety requirements medical devices may not be connected via extension leads or multi-way
connectors.
[4.E5]
Medical electrical systems
The medical electrical system (later in this text referred as “system”) is a combination of several devices, of which
at least one is a medical electrical equipment. A combination occurs when devices are connected via so called
“functional connections” or via a mobile multiple socket. Not only electrical connections are defined as “functional
connections” but also those for the transmission of signals, electrical energy and/or substances. Thus already the
operation of two or more devices on the same multiple outlet is defined as a system. Even a mechanical
connection or a wireless connection produces a medical electrical system.
Basically it is imperative that a system is as safe as a single medical electrical equipment. The requirements in the
medical devices act and the applicable regulations (for example MPBetreibV) must be met. The system as a whole
must ensure that within the patients environment or at contact with patients the same level of safety prevails, as
determined by IEC 60601-1 (VDE 0750 Part 1), IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4 and IEC 60601-1-
6.
[4.E6]
Subject's surroundings
The surroundings of the subject must have a gap of 1.5 m as it has been proofed by experience. This has been
laid down here as the surrounding.
