DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
Page
59
of
61
EN60601-1-2: 2015
Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic
disturbances
–
Requirements and tests
For Professional Healthcare Facility Environment
Reference Standard
Levels
Result
Test
frequency
Band
Service
Modulation
Maximum
Power
Distance
Immunity Test Level
(MHz)
(MHz)
(W)
(m)
(V/m)
385
380-390
TETRA
Pulse Modulation
18Hz
1.8
0.3
27
450
430-470
GMRS 460
FRS460
FM
5kHz deviation
1kHz sinewave
2
0.3
28
710
704-787
LTE Band 13, 17
Pulse Modulation
217Hz
0.2
0.3
9
745
780
810
800-960
GSM 800/900
TETRA 800
iDEN 820
CDMA 850
LTE Band 5
Pulse Modulation
18Hz
2
0.3
28
870
930
1720
1700-1990
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE
Band 1, 3, 4, 25; UMTS
Pulse Modulation
217Hz
2
0.3
28
1845
1970
2450
2400-2570
Bluetooth, WLAN, 802.11
b/g/n, RFID 2450, LTE
Band 7
Pulse Modulation
217Hz
2
0.3
28
5240
5100-5800
WLAN 802.11 a/n
Pulse Modulation
217Hz
0.2
0.3
9
5500
5785
RATED power frequency magnetic fields EN
61000-4-8:2010
Referenced in Table 4 (Page 34)
30A/m
No magnetically sensitive parts
N/A
Input a.c. power Port (Table 5
–
Page 35)
Electrical Fast Transients / Bursts
EN61000-4-4:2012
Referenced in Table 5 (Page 35)
2kV
100kHz repetition frequency
Mode 1
Pass
