Biocare iE 101, User Manual

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Appendix C EMC-Guidance and manufacture’s declaration
User Manual for Electrocardiograph -- 67 --
C.3 Guidance and manufacture’s declaration-electromagnetic immunity for
EQUIPMENT and SYSTEMS those are not LIFE-SUPPORTING
Guidance and manufacture’s declaration-electromagnetic immunity
The ECG machine is intended for use in the electromagnetic environment specified below. The customer of the user of the ECG
machine should assure that it is used in such an environment.
Immunity test IEC60601 test level
Compliance
level
Electromagnetic environment-guidance
Conducted RF
IEC61000-4-6
Radiated RF
IEC61000-4-3
3 Vrms
150kHz -80 MHz
3 V/m
80 MHz -2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the ECG machine, including cables,
than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
P
V
5 . 3
d
1







P
E
5 . 3
d
1







80MHz-800 MHz
P
E
7
d
1







800MHz-2.5 GHz
Where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer and d is
the recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, asdetermined by an
electromagnetic site survey, range
a
should be less than the
Power frequency
(50Hz) magnetic
field
IEC61000-4-8
3A/m 3A/m Mains power quality should be that of
a typical commercial or hospital
environment.
NOTE: UT is the A.C mains voltage prior to application of the test level.