Appendix C Guidance And Manufacturer's Declaration - Welch Allyn SureTemp Plus 692 Series Service Manual

Appendix C Guidance and Manufacturer's Declaration
EMC compliance
Special precautions concerning electromagnetic compatibility (EMC) must be taken for all
medical electrical equipment. This device complies with IEC EN 60601-1-2:2014.
• All medical electrical equipment must be installed and put into service in accordance with
the EMC information provided in this document and the Welch Allyn SureTemp Plus
Directions for Use.
• Portable and mobile RF communications equipment can affect the behavior of medical
electrical equipment.
The SureTemp Plus 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 SureTemp Plus in the presence of high-frequency surgical
equipment.
• However, it is good practice to avoid using the SureTemp Plus in extremely close
proximity to other equipment.
The SureTemp Plus has essential performance requirements associated with
Note
temperature measurement. In the presence of EM disturbances, the device might
display an error code. Once the EM disturbances stop, the SureTemp Plus will self-
recover and perform as intended.
WARNING Avoid using the SureTemp Plus adjacent to or stacked with other
equipment or medical electrical systems because it could result in improper
operation. If such use is necessary, observe the SureTemp Plus and other
equipment to verify that they are operating normally.
WARNING Use only accessories recommended by Welch Allyn for use with the
SureTemp Plus. Accessories not recommended by Welch Allyn might affect the
EMC emissions or immunity.
WARNING Maintain minimum separation distance between the SureTemp Plus
and portable RF communication equipment. SureTemp Plus performance might
degrade if you do not maintain a proper distance between equipment.
WARNING This device has not been tested for use in clinical environments near
high-frequency surgical equipment and magnetic resonance imaging. Do not use
this device in environments like these where electromagnetic disturbance is high.
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