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Technical Information
Technical Information
NOTE:
This product complies with ISO 10993-1, 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 a pulse
oximeter monitor or sensor.
CAUTION:
All parts and accessories connected to the serial port of this device must
be certified according to at least IEC Standard EN 60950, IEC 62368-1, or UL 1950
for data-processing equipment.
CAUTION:
Portable and mobile RF communications equipment can affect medical
electrical equipment.
Table 7: Electromagnetic Emissions
Emissions Test
Compliance
Electromagnetic Environment—Guidance
This device is intended for use in the electromagnetic environment specified below. The user of this device
should ensure that it is used in such an environment.
RF Emissions
CISPR 11
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.
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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