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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 compliance to IEC 60601-1-2 for
this device.
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 9: Electromagnetic Emission
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 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 61000-3-3
N/A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
N/A
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