Directions for use 21
Guidence 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.
NOTE: The SureTemp Plus has essential performance requirements associated with 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 recommend 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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