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Instructions for use
Appendix D: 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 Instructions 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
IEC 61000-3-2
Voltage fluctuations/
flicker 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 Hill Rom for use with the 800
Series. Accessories not recommended by Hill Rom 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
Complies
English 11
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