Philips PageWriter TC70 - Classification (IEC 60601-1); Class II (Internally Powered); Electromagnetic Compatibility (EMC)

Specifications Electromagnetic Compatibility (EMC)
A-8 PageWriter TC 70 Cardiograph Service Manual
Classification (IEC 60601-1)
Class II (Internally Powered)
WARNING When using additional peripheral equipment powered from an electrical source other
than the cardiograph, the combination is considered to be a medical system. It is the
responsibility of the operator to comply with IEC 60601-1-1 and test the medical system
according to the requirements. For additional information contact Philips Medical
Systems.
Electromagnetic Compatibility (EMC)
Electronic devices can either generate or receive electromagnetic interference. The PageWriter
TC70 has been evaluated for electromagnetic compatibility (EMC) with the appropriate
accessories according to Medical Collateral standard IEC 60601-1-2:2001 (with exceptions
noted in proceeding tables). This IEC standard has been adopted in the European Union as the
European Norm, EN 60601-1-2:2001.
WARNING Radio frequency (RF) interference from nearby transmitting devices may degrade
performance of the electronic equipment. Electromagnetic compatibility with
surrounding devices should be assessed prior to using the equipment.
WARNING Fixed, portable, and mobile radio frequency communications equipment can also affect
the performance of electrical equipment. See your Service Provider for assistance with
the minimum recommended separation distance between RF communications
equipment and the PageWriter TC70 cardiograph.
Symbol Meaning
ECG physio isolation is type CF, defibrillator proof. Suitable for all
patient applications including direct cardiac application. System is in
continuous operation.
IPX 0
Cardiograph has ordinary protection against the entry of liquids.
IPX4
The PIM (patient interface module) is protected against splashing water.
Water splashed against the PIM from any direction shall have no harmful
effect.
 Cardiograph is not suitable for use in the presence of flammable anesthetic mixture with
air, oxygen, or nitrous oxide.
 System is continuous operation.