Product Manual

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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: Portable and mobile RF communications equipment can affect medical
electrical equipment.
Table 3: 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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