DYSIS Ultra 2.0 Digital Colposcope Instructions for Use
0330-53095 R4
Revision Date 25-Feb-2021
Page
61
of
61
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)
2, 4, 8, 15kV air
2, 4, 6, 8kV contact No
patient coupling port
N/A
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
Resul
t
Conducted disturbances induced by RF fields EN
61000-4-6: 2014
Referenced in Table 7 (Page 38)
3Vrms
0.15-80MHz
6Vrms in ISM bands between 0.15MHz and
80MHz.
No patient coupling port
N/A
Signal input/output parts Port (Table 8
–
Page 39)
Electrostatic Discharge
EN61000-4-2: 2009
Referenced in Table 8 (Page 39)
2, 4, 8, 15kV air
2, 4, 6, 8kV contact
Mode 1
Pass
Electrical Fast Transients / Bursts
EN61000-4-4:2012
Referenced in Table 8 (Page 39)
1kV
100kHz repetition frequency
Mode 1
Pass
Surges
EN61000-4-5:2006
Referenced in Table 8 (Page 39). This test applies only to output lines
intended to connect directly to outdoor cables
0.5 and 1kV line to line
0.5, 1 and 2kV line to earth No
outdoor cables
N/A
Conducted disturbances induced by RF fields EN
61000-4-6: 2014
Referenced in Table 8 (Page 39)
3Vrms
0.15-80MHz
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
Pass
