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Safety and Performance Tests 34 Installation and Specifications
365
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 Installation and 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 IntelliVue patient
monitors, with the requirements of IEC 60601-1-2:2001.
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
Avoiding Electromagnetic Interference (Resp and BIS)
The respiration (Resp) and BIS measurements are very sensitive measurements that measure very small
signals. Technological limitations don't allow higher immunity levels than 1V/m for radiated RF
electromagnetic fields and 1Vrms for conducted disturbances induced by RF fields. Electromagnetic
fields with field strengths above 1 V/m and conducted disturbances above 1Vrms may cause erroneous
measurements. Therefore Philips recommends that you avoid using electrically radiating equipment in
the close proximity of these measurements.
WARNING The monitor should not be used next to or stacked with other equipment. If you must stack the
monitor, you must check that normal operation is possible in the necessary configuration before you
start monitoring patients.
Emissions test Compliance Avoiding Electromagnetic Interference
Radio Frequency (RF) emissions Group 1 The monitor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment
RF emissions CISPR 11 Class A The monitor is suitable for use in all establishments other
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes
Harmonic emissions IEC 61000-3-2 n/a
Voltage fluctuations IEC 61000-3-3 n/a