Manufacturer's Declaration; Essential Performance - Nonin Onyx Vantage 9590 Instructions For Use Manual

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
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.
The customer and/or user of this device should ensure that it is used in such an environment.
Electrostatic Discharge (ESD)
Power Frequency (50/60 Hz) Magnetic Field
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.
Table 1: Electromagnetic Emissions
Emissions Test
This device is intended for use in the electromagnetic environment specified below.
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Table 2: Electromagnetic Immunity
Immunity Test
IEC 61000-4-2
IEC 61000-4-8
Radiated RF
IEC 61000-4-3
Table 3: Not Applicable
accuracy and pulse rate accuracy or an indication of abnormal
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Compliance
Group 1
Class B
Compliance
±8 kV contact
±15 kV air
30 A/m
80 MHz – 2.7 GHz
380 – 390 MHz
430 – 470 MHz
704 – 787 MHz
800 – 960 MHz
1.7 – 1.99 GHz
2.4 – 2.57 GHz
5.1 – 5.8 GHz
10 V/m
27 V/m
28 V/m
9 V/m
28 V/m
28 V/m
28 V/m
9 V/m
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