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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.
Manufacturer’s Declaration
Refer to the following table for specific information regarding this device’s
compliance to IEC 60601-1-2.
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.
Table 6. Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment—
Guidance
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 2
This device must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment may
be affected.
RF Emissions
CISPR 11
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.
Harmonic
Emissions
IEC 61000-3-2
N/A
Voltage
Fluctuations/
Flicker Emissions
IEC 61000-3-3
N/A
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