Heater-Cooler System 3T • Safety
CP_IFU_16-XX-XX_USA_015 2.5
◗ Ensure optimum ventilation at the ventilation grills and the fan. Insufficient ventilation may result
in excessive heating of the heater-cooler.
◗ The minimum distance of 70 cm to the wall or other devices must be observed!
◗ Modifications or extensions to the device, as well as the use of spare parts which have not been
tested and approved by SORIN GROUP DEUTSCHLAND GMBH, may have negative effects on the
safety and function of the system. SORIN GROUP DEUTSCHLAND GMBH cannot accept any liability
or responsibility in such cases.
◗ Accessories and supplementary devices which have not been tested and approved by
SORIN GROUP DEUTSCHLAND GMBH must prove that their use does not pose a safety hazard (see
chap. 7.4 “Accessories” on page 7.6).
2.2.5 Electrical safety
◗ 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.
◗ Check the functional safety of all electrical connections, cables and sockets regularly!
◗ Mains power quality should be that of a typical commercial or hospital environment.
!
◗ The heater-cooler must be connected to a power supply network with protective conductor (earth)
to protect the device against electric shock.
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