Heater-Cooler System 3T • Safety
2.2 CP_IFU_16-XX-XX_USA_015
2.2 Regulations and safety instructions
2.2.1 Intended use
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◗ In accordance with the applicable regulations, the heater-cooler is intended for use with a
Stöckert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a
separate temperature control for extracorporeal perfusion of durations of up to 6 hours. The water
circuits are used for cooling/heating blood (in the oxygenator), hypothermia blankets or
cardioplegic solutions.
Instructions for use
◗ Any use beyond this specification is not in accordance with the regulations and
SORIN GROUP DEUTSCHLAND GMBH will not assume any liability for damage in such a case. Usage
in accordance with regulations also includes compliance with the operating instructions, as well as
repair and maintenance according to the maintenance instructions.
◗ Relevant accident prevention measures according to existing local policy and employees’ health
and safety regulations must be complied with. SORIN GROUP DEUTSCHLAND GMBH will not
assume any liability for damage due to non-compliance with these regulations.
◗ SORIN GROUP DEUTSCHLAND GMBH will not assume any liability for injuries and/or damage
caused by failure to observe the safety instructions or by the operator not taking due care. This
also applies if the operator’s duty to take due care has not been specifically expressed to the user.
2.2.2 Contraindications
◗ There are no known contraindications for the heater-cooler.
The attending physician is solely responsible for the use of the system.
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