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EMC GUIDANCE
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments.
• Do not 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.
• 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.
• 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.
• 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 TMB-1583-S including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
WARNING
Technical description:
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.
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class [ B ]
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Comply
Table 1
Guidance and manufacturer’s declaration – electromagnetic Immunity
Immunity Test
IEC 60601-1-2
Test level
Compliance level
Electrostatic discharge (ESD) IEC
61000-4-2
±8 kV contact
±2kV,±4kV,±8kV, ±15kV air
±8 kV contact
±2kV,±4kV,±8kV, ±15kV air
Electrical fast transient/burst IEC
61000-4-4
±2 kV for power supply lines
±1 kV signal input/output
100 kHz repetition frequency
±2 kV for power supply lines Not
Applicable
100 kHz repetition frequency
Surge IEC61000-4-5
±0.5 kV, ±1 kV differential mode
±0.5 kV, ±1 kV, ±2 kV common
mode
±0.5 kV, ±1 kV differential mode
Not Applicable
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
Power frequency magnetic field
IEC 61000-4-8
30 A/m
50 Hz / 60 Hz
30 A/m
50 Hz / 60 Hz
Conduced RF IEC61000-4-6
3V
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
3V
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
Radiated RF IEC61000-4-3
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
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2
