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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
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 or
UL 1950 for data-processing equipment.
CAUTION:
Portable and mobile RF communications equipment can
affect medical electrical equipment.
Table 2: 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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