Heater-Cooler System 3T • Safety
CP_IFU_16-XX-XX_USA_015 2.1
2Safety
2.1 Safety requirements and certification
The Heater-Cooler System 3T is a class IIb medical device (MDD 93/42/EEC). A Declaration of
Conformity has been issued for the heater-cooler.
This device complies with the requirements of EU Directive 93/42/EEC
of the European Council for Medical Devices.