Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the following.
Portable and mobile RF communication equipment (e.g. cell phones) can affect Medical Electrical Equipment.
The use of accessories and cables other than those specified (other than A&D original parts) may result in increased emissions or decreased immunity of the unit.
Guidance and manufacturer’s declaration – electromagnetic emissions
The A&D unit is intended for use in the electromagnetic environment specified below.
The customer or the user of the A&D unit should assure that it is used in such an environment.
| Emissions test | Compliance |
Electromagnetic environment – guidance |
| RF emissions
CISPR 11 |
Group 1 | The A&D unit uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. |
| RF emissions
CISPR 11 |
Class A | The A&D unit is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. |
| Harmonic emissions
IEC 61000-3-2 |
Class A | |
| Voltage fluctuations/flicker
emissions IEC 61000-3-3 |
Complies |
Recommended separation distances between portable and mobile RF communications equipment and the A&D unit
The A&D unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the A&D unit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the A&D unit as recommended below, according to the maximum output power of the communications equipment.
| Rated maximum output
power of transmitter W |
Separation distance according to frequency of transmitter m |
||
| 150 kHz to 80 MHz
d = 1.2 P |
80 MHz to 800 MHz
d = 1.2 P |
800 MHz to 2.5 GHz
d = 2.3 P |
|
|
0.01 |
0.12 |
0.12 |
0.23 |
|
0.1 |
0.38 |
0.38 |
0.73 |
|
1 |
1.2 |
1.2 |
2.3 |
|
10 |
3.8 |
3.8 |
7.3 |
|
100 |
12 |
12 |
23 |
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people
Guidance and manufacturer’s declaration – electromagnetic immunity
The A&D unit is intended for use in the electromagnetic environment specified below. The customer or the user of the A&D unit should assure that it is used in such an environment.
| Immunity
test |
IEC 60601
test level |
Compliance
level |
Electromagnetic environment – guidance |
| Conducted RF
IEC 61000-4-6 Radiated RF IEC 61000-4-3 |
3 V rms
150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz |
3 V rms
3 V/m |
Portable and mobile RF communications equipment should be used no closer to any part of the A&D unit, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance: d = 1.2√P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: |
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
- Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the A&D unit is used exceeds the applicable RF compliance level above, the A&D unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the A&D unit.
- Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and manufacturer’s declaration – electromagnetic immunity
The A&D unit is intended for use in the electromagnetic environment specified below. The customer or the user of the A&D unit should assure that it is used in such an environment.
| Immunity test | IEC 60601 test level | Compliance level | Electromagnetic environment – guidance |
| Electrostatic discharge (ESD) IEC 61000-4-2 | ± 6 kV
contact ± 8 kV air |
± 6 kV
contact ± 8 kV air |
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. |
| Electrical fast transient/burst IEC 61000-4-4 | ± 2 kV for power supply lines
± 1 kV for input/output lines |
± 2 kV for power supply lines
± 1 kV for input/output lines |
Mains power quality should be that of a typical commercial or hospital environment. |
| Surge
IEC 61000-4-5 |
± 1 kV
line to line ±2 kV line to earth |
± 1 kV
line to line ±2 kV line to earth |
Mains power quality should be that of a typical commercial or hospital environment. |
| Voltage dips, short interruptions and voltage variations on power supply input lines
IEC 61000-4-11 |
< 5% UT (> 95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles < 5% UT |
< 5% UT (> 95% dip in UT) for 0.5 cycle40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles < 5% UT |
Mains power quality should be that of a typical commercial or hospital environment. If the user of the A&D unit requires continued operation during power mains interruptions, it is recommended that the A&D unit be powered from an uninterruptible power supply or a battery. |
| Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 | 3 A/m | 3 A/m | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
NOTE: UT is the AC mains voltage prior to application of the test level.