Asra Curve User Guide V9
27/05/2021
Page
34
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40
Appendix 1: Guidance on the Electromagnetic environment in which to operate the
instrument.
Use of portable telephones or other radio frequency (RF) emitting equipment
near the system may cause unexpected or adverse operation
•
The ASRA Curve has been tested to EN60601-1-2:2015, regarding its ability to operate
in an environment containing other electrical/electronic equipment (including other
medical devices).
•
The purpose of this testing is to ensure that the ASRA Curve is not likely to adversely
affect the normal operation of other such equipment and that other such equipment is
not likely to adversely affect the essential operation of the ASRA Curve.
•
Despite the testing of the ASRA Curve that has been undertaken, normal operation can be
affected by other electrical/electronic equipment and portable and mobile RF
communications equipment.
•
As the ASRA Curve is medical equipment, special precautions are needed regarding EMC
(electromagnetic compatibility).
•
It is important that the ASRA Curve is configured and installed/put into service, in
accordance with the instructions/guidance provided herein and is used only in the
configuration as supplied.
•
Changes or modifications to the ASRA Curve may result in increased emissions or decreased
immunity of the instrument in relation to EMC performance.
•
The ASRA Curve should be used only with the cables, accessories and transducers provided
by GM Instruments. The cables should not be extended by the user. If the cable is extended
by the user, this may result in an increased level of emissions or decreased level of
immunity, in relation to the ASRA Curve EMC. The use of the cables, accessories and
transducers with devices other than the ASRA Curve, may result in an increased level of
emissions or decreased level of immunity, in relation to the other device’s
EMC.
•
The ASRA Curve should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use with other equipment is necessary, the ASRA Curve and the other
equipment should be observed/monitored, to verify normal operation in the configuration
in which it will be used.
•
For the purposes of EN60601-1-2 the ASRA Curve has an essential performance (The
instrument should not produce tones greater than 100dB unless permitted by the user).