Safety and Performance Tests 31 Installation and Specifications
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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 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
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 those directly connected to the public low-voltage
power supply network that supplies buildings used for
domestic purposes.
RF emissions CISPR 11 Class B The monitor, with the following measurements and
interfaces:
ECG/Respiration, NBP, SpO
2
, Pressure, Temperature, CO
2
(only Mainstream Sensor M2501A)
LAN, Video Out, Battery, Nurse Call, RS232, and recorder
interfaces
is suitable for use in all establishments including those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2 complies
Voltage fluctuations IEC 61000-3-3 complies