ADLINK MLC 4-21 - Manual (Page 36)

MLC 4-xx Technical Manual Rev. 1.2 Appendix
Document: Manual_Medical_MLC_1.2 Page 36 of 37 pages Last change date: 18-Feb-15
13.1.3.
Guidance and manufacturer’s declaration - electromagnetic immunity - for EQUIPMENT and SYSTEM that are not LIFE-
SUPPORTING (IEC 60601-1-2:2007 Table 4)
The MLC 4-xx is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an
environment.
Immunity Test
IEC/EN 60601-1-2:2007
(3
rd
edition) Test Level
IEC 60601-1-2:2014
(4
th
edition) Test Level
Device complies to
Electromagnetic Environment - Guid-
ance
Radiated RF
IEC 61000-4-3
3V/m, 80-2500MHz, 1kHz/2Hz
80%AM modulation
10V/m, 80-2500MHz, 1kHz/2Hz
80%AM modulation for life sup-
port equipment
Dwell Time is 3 seconds for 2Hz
modulation
Dwell Time is 1 second for 1kHz
modulation
3V/m, 80-2700MHz, 1kHz
80%AM modulation for Profes-
sional Healthcare Facility Envi-
ronment
10V/m, 80-2700MHz, 1kHz
80%AM modulation for Home
Healthcare Environment
IEC/EN 60601-1-2:2007
Life support equipment
IEC 60601-1-2:2014
Home Healthcare Environment
Portable and mobile RF communications
equipment should be used no closer to
any part of the device, including cables,
than the recommended separation dis-
tance calculated from the equation appli-
cable to the frequency of the transmitter.
Recommended separation distance:
𝑑 = 1.2 × √𝑃 from 150kHz to 80MHz
𝑑 = 1.2 × √𝑃 from 80MHz to 800MHz
𝑑 = 2.3 × √𝑃 from 800MHz to 2.5GHz
where P is the maximum output power
rating of the transmitter in watts (W) ac-
cording to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey [a], should be less than the compli-
ance level in each frequency range [b].
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
Conducted RF
IEC 61000-4-6
3Vrms, 0.15-80 MHz, 1kHz/2Hz
80% AM modulation
3Vrms, 0.15-80 MHz, 1kHz/2Hz
80% AM modulation for life sup-
port equipment
3Vrms, 0.15-80 MHz, 1kHz 80%
AM modulation
6Vrms in ISM bands (I/O cables
< 3m excluded)
10Vrms
IEC/EN 60601-1-2:2007
IEC 60601-1-2:2014
NOTE 1 - At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 - These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.