Guidence And Manufacturer's Declaration; Emc Compliance; Emissions And Immunity Information - Welch Allyn 690 Directions For Use Manual

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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 60601-1-2:2007.
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The Welch Allyn SureTemp Plus complies with all applicable and required standards for
electromagnetic interference.
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Emissions and Immunity Information

The Welch Allyn SureTemp Plus model 690 and 692 is intended for use in the electromagnetic environment specified
below. The customer or the user of the Welch Allyn thermometer should assure that it is used in such an
environment.
Emissions Test Compliance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
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 PlusDirections for Use.
Portable and mobile RF communications equipment can affect the behavior of medical electrical
equipment.
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.
Electromagnetic Emissions
Electromagnetic Environment - Guidance
The Welch Allyn SureTemp Plus 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.
The Welch Allyn SureTemp Plus models 690 and 692 are suitable for
use in all establishments other than domestic, and may be used in
domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
WARNING: This equipment/system is intended for use by
healthcare professionals only. This equipment/system may
cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to take mitigation measures,
such as re-orienting or relocating the Welch Allyn SureTemp
Plus models 690 and 692 or shielding the location.
Welch Allyn SureTemp Plus