36 Specifications
427
Safety and Performance Tests
You must observe any national regulations on the qualification of the testing personnel and suitable
measuring and testing facilities. See the maintenance section for a list of required tests. Safety and
performance tests, and what to do if the instrument does not meet these specifications, are described
in the Service Guide.
Electromagnetic Compatibility (EMC) Specifications
Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical
equipment. You must operate your monitoring equipment according to the EMC information
provided in this book. Portable and mobile radio frequency (RF) communications equipment can
affect medical electrical equipment.
Accessories Compliant with EMC Standards
All accessories listed in the accessories section comply, in combination with the patient monitor, with
the requirements of IEC 60601-1-2:2001 + A1:2004.
WARNING
Using accessories other than those specified may result in increased electromagnetic emission or
decreased electromagnetic immunity of the monitoring equipment.
Electromagnetic Emissions
The monitor is suitable for use in the electromagnetic environment specified in the table below. You
must ensure that it is used in such an environment.
Bandwidth 0.25 - 100 Hz (-3 dB)
High Pass Filters 0.25Hz, 1Hz, 2Hz (-3dB)
Low Pass Filters 30 Hz, 50 Hz, 70 Hz, 100 Hz (-3 dB)
Notch Filters (for line frequency) 50 Hz, 60 Hz
Impedance Measurement Range 0 to 999 kΩ
BIS Alarm Specifications Range Adjustment Alarm Delay
BIS High/Low Alarm 0 - 100 1 Max. 2 seconds
BIS Performance Specifications BIS, BISx M1034A
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