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WARNING: Portable RF communications equipment such as cell phones or radios (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ME system, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Manufacturer’s Declaration
Refer to the following tables for specific information regarding this device’s compliance to IEC 60601-1-2.
Essential Performance
Essential performance of the 9590 is defined as SpO
2
accuracy and pulse rate accuracy or an indication of abnormal
operation. Accuracies may be affected as a result of exposure to electromagnetic disturbances that are outside of the
environments listed in the Indications For Use. If issues are experienced, move the Nonin system away from the source of
electromagnetic disturbances.
Table 1: Electromagnetic Emissions
Emissions Test Compliance
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.
RF Emissions
CISPR 11
Group 1
RF Emissions
CISPR 11
Class B
Table 2: Electromagnetic Immunity
Immunity Test Compliance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Power Frequency (50/60 Hz) Magnetic Field
IEC 61000-4-8
30 A/m
Radiated RF
IEC 61000-4-3
80 MHz – 2.7 GHz 10 V/m
380 – 390 MHz 27 V/m
430 – 470 MHz 28 V/m
704 – 787 MHz 9 V/m
800 – 960 MHz 28 V/m
1.7 – 1.99 GHz 28 V/m
2.4 – 2.57 GHz 28 V/m
5.1 – 5.8 GHz 9 V/m
Table 3: Not Applicable
Harmonic Emissions (IEC 61000-3-2), Voltage Flicker Emissions (IEC 61000-3-3), Electrical Fast Transients (IEC 61000-4-
4), Surge (IEC 61000-4-5), Voltage dips (IEC 61000-4-11), Conducted Immunity (IEC 61000-4-6)
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
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