Use Instructions

Guidance and manufacturer’s declaration — electromagnetic immunity
The ML6710i is intended for use in the electromagnetic environment specified below. The owner/
user of this device is responsible for assuring that it is used in such an environment.
Table 11. Electromagnetic immunity – ML6710i device.
Immunity test IEC 60601-1-2 test level Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
3 V 0,15 MHz – 80 MHz
6 V in ISM bands between 0,15 MHz and 80 MHz
80 % AM at 1 kHz
Electromagnetic environment should be
that of a typical hospital environment
except for near active HF surgical
equipment and the RF shielded room for
magnetic resonance imaging, or other
special environments where the intensity
of electromagnetic disturbance is high.
Radiated RF
IEC 61000-4-3
3 V/m 80 MHz – 2,7 GHz
80 % AM at 1 kHz
Frequency
(MHz)
Band (MHz) Service Modulation
Maximum
power (W)
Distance
(m)
Test level
immunity (V/m)
385 380 –390 TETRA 400
Pulse modulation 18Hz
50 % square wave
1.8 0.3 27
450 430 – 470 GMRS 460, FRS 460
FM ± 5 kHz deviation 1
kHz sine
2 0.3 28
710, 745, 780 704 – 787 LTE Band 13, 17
Pulse modulation 217 Hz
50 % square wave
0.2 0.3 9
810, 870, 930 800 – 960
GSM 800/900, TETRA 800,
iDEN 820, CDMA 850, LTE
Band 5
Pulse modulation 18 Hz
50 % square wave
2 0.3 28
1720, 1945,
1970
1700 – 1990
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE Band
1, 3, 4, 25; UMTS
Pulse modulation 217
Hz 50 % square wave
2 0.3 28
2 450 2400 – 2570
Bluetooth, WLAN, 802.11
b/g/n, RFID 2450, LTE
Band 7
Pulse modulation 217
Hz 50 % square wave
2 0.3 28
5240, 5500,
5785
5100 – 5800 WLAN 802.11 a/n
Pulse modulation 217
Hz 50 % square wave
0.2 0.3 9
Table 12. Proximity fields from RF wireless communications equipment – IEC 61000-4-3.
In case essential performance of ML6710i is lost or degraded due to electromagnetic
disturbances the device will stop or pause ongoing treatment and starting a new
treatment may not be possible until electromagnetic disturbance is removed.
Revision 9
57Guidance and manufacturer’s declaration – electromagnetic emissions