Technical Information; Manufacturer's Declaration; Table 6. Electromagnetic Emissions - Nonin Sensmart H500 Operator's Manual

Multi-sensing portable oximetry system
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Technical Information

Technical Information
NOTE: This product complies with ISO 10993, Biological Evaluation of
Medical Devices Part 1: Evaluation and Testing.
CAUTION: A functional tester cannot be used to assess the accuracy of
!
the oximeter monitor or sensor.
CAUTION: Portable and mobile RF communications equipment can
!
affect medical electrical equipment.

Manufacturer's Declaration

Refer to the following table 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 should ensure that it is used in
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic
Emissions
IEC 61000-3-2
Voltage
Fluctuations/
Flicker Emissions
IEC 61000-3-3

Table 6. Electromagnetic Emissions

Compliance
such an environment.
Group 2
Class B
N/A
N/A
Electromagnetic Environment—
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.
Guidance
39

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