Welch Allyn KleenSpec 800 Series Directions For Use Manual page 13

Directions for use
Appendix C: EMC guidance and manufacturer's declarations
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC 60601-1-2:2014/EN
60601-2-1:2015.
• All medical electrical equipment must be installed and put into service in accordance
with the EMC information provided in this Directions for use.
• Portable and mobile RF communications equipment can affect the behavior of
medical electrical equipment.
The device complies with all applicable and required standards for electromagnetic
interference.
• It does not normally affect nearby equipment and devices.
• It is not normally affected by nearby equipment and devices.
• It is not safe to operate the device in the presence of high-frequency surgical
equipment.
• However, it is good practice to avoid using the device in extremely close proximity to
other equipment.
Emissions and immunity information
The Welch Allyn KleenSpec 800 Series is intended for use in the electromagnetic environment specified below. The
customer or user of the 800 Series should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
WARNING The use of the 800 Series adjacent to or stacked with other
equipment or medical electrical systems should be avoided because it
could result in improper operation. If such use is necessary, the 800 Series
and other equipment should be observed to verify that they are operating
normally.
WARNING Use only Accessories recommended by Welch Allyn for use
with the 800 Series. Accessories not recommended by Welch Allyn may
affect the EMC emissions or immunity.
WARNING Maintain minimum separation distance between the 800
Series and portable RF communication equipment. Performance of the 800
Series may be degraded if proper distance is not maintained.
Electromagnetic emissions
Compliance Electromagnetic environment - guidance
Group 1 The 800 Series 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.
Class B
The 800 Series is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low
voltage power supply network that supplies buildings used for domestic
purposes.
Class A
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