DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0230-53095, Rev 05
Revision Date 05-Mar-2021
Page
78
of
79
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
Conducted disturbances induced by RF fields
3Vrms
Pass
EN 61000-4-6: 2014
0.15-80MHz
Referenced in Table 5 (Page 35)
6Vrms in ISM bands between
0.15MHz and 80MHz.
The ISM (industrial, scientific and
medical) bands between 0.15MHz
and 80MHz are 6.765MHz to 6.795
MHz; 13.553MHz to 13.567MHz;
26.957MHz to 27.283MHz; and
40.66MHz to 40.70MHz
Mode 1
Voltage Dips and Interrupts
0 % U
T
; 0,5 cycle
Pass
EN 61000-4-11:2004
Referenced in Table 5 (Page 35)
at 0°, 45°, 90°, 135°, 180°, 225°,
270° and 315°
0 % U
T
; 1 cycle
and
70 % U
T
; 25/30 cycles
Single phase: at 0°
0 % U
T
; 250/300 cycle
Mode 1
230V and 100V
Input DC Power Port (Table 6
–
Page 37)
Electrical Fast Transients / Bursts
EN61000-4-4:2012
Referenced in Table 6 (Page 37)
No DC port
N/A
Surges
EN61000-4-5:2006
Referenced in Table 6 (Page 37)
No DC port
N/A
Conducted disturbances induced by RF fields
No DC port
N/A
EN 61000-4-6: 2014
Referenced in Table 6 (Page 37)
Electrical Transient conduction along supply lines
ISO7637-2
Not applicable
N/A
Patient coupling port (Table 7
–
Page 38)
Electrostatic Discharge
EN61000-4-2: 2009
Referenced in Table 7 (Page 38)
No patient coupling port
N/A