sorin 3T - Regular Maintenance Checks by Authorized Service Technicians; Disposal in Accordance with Environmental Regulations

Heater-Cooler System 3T • Routine maintenance
6.4 CP_IFU_16-XX-XX_USA_015
6.1.3 Regular maintenance checks by authorized service technicians
According to the European Directive 93/42 and other national standards
SORIN GROUP DEUTSCHLAND GMBH defines that a preventive maintenance check has to be carried
out after every 1,000 operating hours or at least after every 12 months, whichever comes first.
This preventive maintenance includes but is not limited to
– Status checks
– Electrical safety checks
– Operational safety checks
– Status of the water circuits/ tanks for calcification and biofilm
– Decalcification and/or disinfection as needed
The operator/owner is responsible for assignment of this preventive maintenance to SORIN GROUP
representatives or qualified service personnel
6.1.4 Disposal in accordance with environmental regulations
◗ The heater-cooler must not be disposed of in accordance with Directive 2012/19/EU or its
national transpositions as the system is to be regarded as potentially infectious at the end of
its service life.
◗ All disposables used in conjunction with the heater-cooler must be disposed of in accordance
with the local environmental regulations. Observe hospital regulations when disposing of
these items.
◗ The cooling circuit of the heater-cooler is filled with a CFC-free HFC-(hydrofluorocarbons)
refrigerant. Please see the system label for further information about the type and volume of
the refrigerant to be used. Repair work on the cooling circuit and disposal of the refrigerant
must only be performed by an expert for refrigerant systems.