The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
Warning:
Don’t be near the active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, 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 equipment
and the other equipment should be observed to verify that they are operating normally.
Warning:
Use of accessories, transducers and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
Warning:
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the equipment CH-B2-11-AA including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
1. All necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration-electromagnetic emissions and Immunity.
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
RF emissions
CISPR 11
RF emissions
CISPR 11
Group 1
Class B
Class A
Comply
Compliance
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Emissions test
Table 2
EMC GUIDANCE
EMC GUIDANCE
Guidance and manufacturer’s declaration – electromagnetic Immunity
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Electrostatic
discharge (ESD)
IEC 61000-4-2
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repetition frequency
±2 kV for power supply lines
NA 100 kHz repetition
frequency
±0.5 kV, ±1 kV differential mode
±0.5 kV, ±1 kV, ±2 kV common mode
±0.5 kV, ±1 kV differential
mode N/A
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
Immunity Test
Compliance level
IEC 60601-1-2
Test level
30 A/m
50 Hz / 60 Hz
30 A/m
50 Hz / 60 Hz
Power frequency
magnetic field
IEC 61000-4-8
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% UT ; 0,5 cycle. At 0°, 45°, 90°,
135°, 180°, 225°, 270° and 315°.
0% UT ; 1 cycle and 70% UT ;
25/30 cycles; Single phase: at 0°.
0% UT ; 250 / 300 cycle
0% UT ; 0,5 cycle. At 0°, 45°,
90°, 135°, 180°, 225°, 270°
and 315°. 0% UT ; 1 cycle and
70% UT ; 25/30 cycles;
Single phase: at 0°. 0% UT ;
250 / 300 cycle
Conduced RF
IEC61000-4-6
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz 80% AM at 1 kHz
3 V
0,15 MHz – 80 MHz
6 V in ISM and amateur radio
bands between 0,15 MHz and
80 MHz
80% AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
10 V/m
80 MHz – 2,7 GHz
80% AM at 1 kHz
Radiated RF
IEC61000-4-3
26
25
Technical description:
