Covidien INVOS 5100C, Operator'S Manual

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Guidance and Manufacturer’s Declaration—Electromagnetic Compatibility (EMC)
Operator's Manual A-7
A.3.1
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The INVOS™ system is intended for use in the electromagnetic environment specified below. The
customer or user of the INVOS™ system should ensure that it is used in such an environment.
A.3.2
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The INVOS™ system is intended for use in the electromagnetic environment specified in Table A-
9. The customer or user of the system should ensure that it is used in such an environment.
Table A-8. Electromagnetic Emissions
Emissions test Compliance Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1 The INVOS™ system 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 INVOS™ system is suitable for use in all establishments
other than domestic and those directly connected to the
public low-voltage power network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
N/A
Voltage fluctuations/flicker emissions
IEC / EN 61000-3-3
N/A
Table A-9. Electromagnetic Immunity
Immunity test IEC/EN 60601-1-2 test
level
Compliance level Electromagnetic environment
guidance
Electrostatic discharge (ESD)
IEC/EN 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete,
or ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient / burst
IEC/EN 61000-4-4
± 2 kV for power supply
lines
±1 kV for input/output
lines
± 2 kV for power supply
lines
±1 kV for input/output
lines
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC/EN 61000-4-5
± 1 kV differential mode
±2 kV common mode
± 1 kV differential mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.