Emc Guidance - Naggura Swop Physio Instruction Manual

11. EMC Guidance

Guidance and Manufacturer's Declaration
- Electromagnetic Emissions
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Warning: Maintain minimum distance of 12 inches (30 cm) between any part of the working table and portable
RF communication equipment (including peripherals such as antenna cables and external antennas.) Perfor-
mance of the table might degrade if proper distance is not maintained.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transient
/burst IEC 61000-4-4
Surge IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
Power frequency (50/60 Hz)
Magnetic field IEC61000-4-8
Conducted RF
IEC61000-4-6
Radiated RF IEC61000-4-3
Compliance
Group 1
Class A
Class A
Complies
±8 kV contact
±2 kV, ±4 kV, ±kV, ±15 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
0% U; 0.5 cycle T at 0º, 45º,90º,
135º, 180º, 225º, 270º, 315º
0% UT; 1 cycle
70% UT; 25/30 cycle
0% U; 250/300 cycle
30 A/m
50Hz/60Hz
3 V r.m.s.
150 kHz to 80 MHz
6 V RMS in the ISM bands
between 0.15 MHz and 80 MHz
3 V/m
80 MHz - 2,7 GHz
80% AM at 1 kHz
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Warning: It is not safe to operate the device in
the presence of HF surgical equipment or places
where the intensity of EM disturbances is high.
Warning: Use of this equipment adjacent to or
stacked with other equipment should be avoided
because it could result in improper operation. If
such use is necessary, this device and other equi-
pment should be observed to verify that they are
operating normally.
Warning: Use only accessories and cables
provided by the manufacturer. Accessories and
cables not recommended may affect the EM
emissions or immunity.
IEC 60601-1-2
Test level
Compliance level
±8 kV contact
±2 kV, ±4 kV, ±kV, ±15 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
0% U; 0.5 cycle T at 0º, 45º,90º,
135º, 180º, 225º, 270º, 315º
0% UT; 1 cycle
70% UT; 25/30 cycle
0% U; 250/300 cycle
30 A/m
50Hz/60Hz
3 V r.m.s.
150 kHz to 80 MHz
6 V RMS in the ISM bands
between 0.15 MHz and 80 MHz
3 V/m
80 MHz - 2,7 GHz
80% AM at 1 kHz
Instruction
Manual
19