Insightec Exablate 2100V1 - Summary of EMC Test Results

SAFETY
Manual Part Number
41
b. Verifies that the monitoring is running continuously.
c. If failure of any of the above does NOT stop the sonication/halts the CSA (Control System
Application), the system is NOT safe.
2. Transducer Motion:
a. Control of the Transducer robotic arm movement.
b. Verification that the Transducer robotic arm is at the correct location and orientation
c. Verification that transducer robotic arm position monitoring is performed continuously.
d. If failure of any of the above does NOT stop the energy sonication and halts the movement, the
system is NOT safe.
2.7.1. Summary of EMC Test Results
Test
Standard
Class/Severity Level
Test
Result
Documentation (IEC 60601-1-2 sections 4 and 5)
General requirements
(Risk Management file)
Section 4.1
-
Complies
Instruction for use
Section 5.2.1
-
Complies
Technical description
Section 5.2.2
-
Complies
Emission (IEC 60601-1-2 sections 7.1-7.2)
Conducted emission
Freq. range: 150 kHz - 30 MHz
CISPR 11
Group 1 Class A on AC mains
Complies
Radiated emission
Freq. range: 30 - 1000 MHz
CISPR 11
Group 1 Class A
Complies
Immunity (IEC 60601-1-2 sections 8.9-8.10)
Immunity from Electrostatic discharge
(ESD)
IEC/EN 61000-4-2
± 8 kV contact discharges &
± 15 kV air discharges
Complies
Immunity from radiated electromagnetic
fields
IEC/EN 61000-4-3
1.0 V/m;
80 MHz  2.7 GHz, 80% AM, 1 kHz
Complies
Immunity from Proximity field from
wireless communications equipment
IEC/EN 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