SCPC System • Safety
CP_SEM_60-03-00.002
11
2.2.4
Electrical Safety
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Mains power quality should be that of a typical commercial or hospital environment.
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The SCPC System must be connected to a power supply network with protective conductor (earth)
to protect the device against electric shock.
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A potential equalization cable must be connected to a point intended for such purpose in the
operating theatre (OT).
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Check the functional safety of all electrical connections, cables and sockets regularly.
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Accessories and supplementary devices must comply with the relevant IEC or ISO standards (e.g.
IEC 60950 regarding information technology equipment). In addition, any configuration must meet
the requirements for medical electrical systems (see IEC 60601-1-1 or paragraph 16 of IEC 60601-1,
3rd edition). Any person connecting additional devices to medical electrical equipment is
considered a system configurer and is thus responsible for ensuring that the system meets the
standard-related requirements for systems. Please note that local legislation takes precedence
over the above-mentioned standard-related requirements.
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The devices must only be connected by means of serial connection cables which comply with the
specifications of LIVANOVA DEUTSCHLAND GMBH (e.g. part no. 45-11-03). The end of the cable
marked with the part number must be plugged into the jack (of the LIVANOVA DEUTSCHLAND GMBH
equipment) intended for serial connection.
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Medical electrical equipment may not be placed directly next to or on top of each other during
operation in order to avoid electromagnetic interference. If such a set-up is required for operation,
the devices must be monitored to ensure that they are functioning properly.
Содержание 60-03-00
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