User's Manual

Electromagnetic Compatibility
Safety Standards & Specifications
12-5
AC Power
Source
The system is not intended for connection to the public mains as defined in
CISPR11.
Software
Hazard
Prevention
Potential hazards arising from errors in the software program have been
identified. Mitigations applied to reduce the associated risk of such hazards are
included as part of the Risk Management, Clinical Evaluation, and Verification
and Validation phases of the product’s development.
Electromagnetic Compatibility
Medical electrical equipment can either generate or receive electromagnetic
interference. This product has been evaluated for electromagnetic compatibility
(EMC) with the appropriate accessories according to IEC 60601-1-2:2001, the
international standard for EMC for medical electrical equipment. This IEC
standard has been adopted in the European Union as the European Norm, EN
60601-1-2:2001.
Radio frequency (RF) interference from nearby transmitting devices can degrade
performance of the product. Electromagnetic compatibility with surrounding
devices should be assessed prior to using the product.
Fixed, portable, and mobile radio frequency communications equipment can also
affect the performance of medical equipment. See your service provider for
assistance with the minimum recommended separation distance between RF
communications equipment and the product.
The cables, sensors/transducers, and other accessories for which compliance is
claimed are listed in the Service and User documentation accompanying the
product.