Manufacturer's Declaration - Nonin Onyx II 9560 Instructions For Use Manual

Manufacturer's Declaration

Refer to the following tables for specific information regarding this device's compliance to IEC 60601-1-2.
Emissions Test
This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/Flicker
Emissions
IEC 61000-3-3
Immunity Test
This device is intended for use in the electromagnetic environment specified below. The customer and/or user of this device should ensure that it is
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical Fast Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions,
and voltage variations on power
supply input lines
IEC 61000-4-11
Power Frequency (50/60 Hz)
Magnetic Field
IEC 61000-4-8
NOTE: U is the AC mains voltage before application of the test level.
T
Table 1: Electromagnetic Emissions
Compliance
should ensure that it is used in such an environment.
Group 2
Class B
N/A
N/A
Table 2: Electromagnetic Immunity
IEC 60601 Test Level
used in such an environment.
±6 kV contact
±8 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV differential mode
±2 kV common mode
±5% U (>95% dip in U ) for 0.5 cycle
T T
±40% U (60% dip in U ) for 5 cycles
T T
±70% U (30% dip in U ) for 25 cycles
T T
<5% U (>95% dip in U ) for 5 sec.
T T
3 A/m
Electromagnetic Environment—Guidance
This device must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected.
This device is suitable for use in all establishments, including
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Compliance
Electromagnetic Environment—Guidance
Level
Floors should be wood, concrete, or ceramic tile. If
±6 kV contact
floors are covered with synthetic material, relative
±8 kV air
humidity should be at least 30%.
Mains power quality should be that of a typical
N/A
commercial or hospital environment.
Mains power quality should be that of a typical
N/A
commercial or hospital environment.
Mains power quality should be that of a typical
N/A
commercial or hospital environment.
Power frequency magnetic fields should be at levels
3 A/m characteristic of a typical location in a typical
commercial or hospital environment.
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