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Manufacturer's Declaration - Nonin Onyx II 9550 Instructions For Use

Finger pulse oximeter

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Manufacturer's Declaration

Refer to the following tables for specific information regarding this device's compliance to IEC 60601-1-2.
Table 1: Electromagnetic Emissions
Emissions Test
The customer and/or user of this device should ensure that it is used in such an environment.
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-3
Voltage Fluctuations/Flicker Emissions
IEC 61000-3-3
Table 2: Electromagnetic Immunity
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 used in such an environment.
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
Compliance
This device is intended for use in the electromagnetic environment specified below.
Group 1
This device 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.
Class B
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.
N/A
N/A
IEC 60601 Test Level
±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
Compliance
Level
Environment—Guidance
±6 kV contact
Floors should be wood, concrete, or ceramic tile. If
floors are covered with synthetic material, relative
±8 kV air
humidity should be at least 30%.
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
N/A
Mains power quality should be that of a typical
commercial or hospital environment.
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Electromagnetic

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