Appendix - GERATHERM oxy control Gebrauchsanweisung

APENDIX
Information on electromagnetic compatibility (EMC)
Electronic devices such as PCs and mobile phones can lead to
the exposure of medical devices in operation to electromagnetic
interference from other devices. This can lead to malfunction of
the medical device and create a potentially unsafe situation.
Medical devices should also not interfere with any other devices.
The EN 60601-1-2 standard regulates the requirements for EMC
(electromagnetic compatibility) and defines the levels of immuni-
ty to electromagnetic
interference and the maximum electromagnetic emission levels
for medical devices.
This pulse oximeter, which is manufactured by Geratherm Medi-
cal AG, complies with the EN 60601-1-2:2007 standard in relati-
on to both immunity and emissions.
However, special precautions should be observed:
Guidance and manufacturer´s declaration - electromagnetic
emissions. The device is intended for use in the electromagne-
tic environments listed below, and should only be used in such
environments:
Emissions
Test
RF-emissions
CISPR 11
RF-emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage fluctu-
ations / flicker
emissions IEC
61000-3-3
y BA.indd 23
Electromagnetic environment -
Compliance
guidance
RF energy is used only to maintain
Group 1
device's operation. Therefore, its RF
emissions are so low that it's not likely
to cause any interference in nearby
electronic equipment.
Class B The device is suitable for use in all
establishments, including domestic
establishments, and those directly
Not applied connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
Not applied
23
GB
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