InMode EVOLVE X - Page 58

Evolve System Operator Manual
Section 11: System Specifications
53
▪ Use of the System with any accessory, transducer or cable other than
those specified may result in increased EMISSIONS or decreased
IMMUNITY than those specified.
▪ The System should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the System should
be observed to verify normal operation in the configuration in which it
will be used.
IEC 60601-1-2 Edition 4.0 (2014)
Environment of intended uses:
Professional Healthcare Facility Environment
Summary of Test Results
Test
Standard
Class/ Severity level
Test
result
Emission (IEC 60601-1-2 section 7.1 & 7.2 & IEC 60601-2-2)
Radiated emission
Freq. range: 30 - 1000 MHz
CISPR 11
Group 1 Class A
Complies
Conducted emission
Freq. range:150 kHz - 30 MHz
Group 1 Class A
100/ 120/ 230 VAC
Complies
Harmonic current emission
test
IEC 61000-3-2
AC mains
Exempted
Voltage changes, Voltage
fluctuations and Flicker test
IEC 61000-3-3
AC mains
Complies
Immunity (IEC 60601-1-2 section 8.9 & 8.10 IEC 60601-2-2)
Immunity from Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact discharges &
15 kV air discharges
Complies
Immunity from radiated
electromagnetic fields
IEC 61000-4-3
3.0 V/m
80 MHz  2.7 GHz, 80% AM, 1kHz
Complies
Immunity from
Proximity field from wireless
communications equipment
IEC 61000-4-3
List of frequencies,
from 9 V/m up to 28 V/m,
PM (18 Hz or 217 Hz), FM 1 kHz
Complies
Immunity from Electrical Fast
transient (EFT)
IEC 61000-4-4
± 2 kV on 230 VAC mains,
Pedal, Applicator
Tr/Th – 5/50 ns, 100 kHz
Complies
Immunity from Surge
IEC 61000-4-5
±1.0 kV DM/ 2.0kV CM on 230 VAC
Tr/Th – 1.2/50 (8/20) s
Complies
Immunity from conducted
disturbances induced by RF
fields
IEC 61000-4-6
3.0 & 6.0 VRMS on 230 VAC mains,
Pedal, Applicator
0.15÷ 80 MHz, 80% AM, 1 kHz
Complies
Immunity from Voltage dips,
short interruptions and
voltage variations
IEC 61000-4-11
230 & 100 VAC mains;
0 % - 10 ms; 70% - 500 ms;
0% - 20 ms; 0% - 5sec
Complies