Electromagnetic declarations and tables

EN 60601-1-2:2007 – Table 1 (emissions for all Medical Equipment)

Lumie products are intended for use in the electromagnetic environment specified below. The customer or the user should assure that the product is used in such an environment.

Emissions Test Compliance Electromagnetic Environment
RF Emissions
CISPR 11
Group 1 Lumie products use RF energy only for its internal functions. Therefore RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B Lumie products are 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
EN 61000-3-2
Class A (unspecified)
Flicker
EN 61000-3-3
Complies

 

EN60601-1-2:2007 – Table 2 (immunity for all Medical Equipment)

Lumie products are intended for use in the electromagnetic environment specified below. The customer or the user should assure that the product is used in such an environment.

Immunity Test IEC60601
Test Level
Compliance Level Electromagnetic Environment
Electrostatic discharge (ESD) IEC 61000-4-2 ±2, 4, 6 kV contact ±2, 4, 8kV air ±2, 4, 6 kV contact ±2, 4, 8kV 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 IEC61000-4-4 ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be of a typical commercial or hospital environment.
Surge IEC 61000-4-5 ±0.5, 1 kV line(s) to line(s) ±0.5, 1, 2 kV line(s) to earth ±0.5, 1 kV line(s) to line(s) ±0.5, 1, 2 kV line(s) to earth Mains power quality should be of a typical commercial or hospital environment.
Voltage dips, short interruptions and voltage variation on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5s
<5% UT (>95% dip in UT) for 0.5 cycle
40% UT (60% dip in UT) for 5 cycles
70% UT (30% dip in UT) for 25 cycles
<5% UT (>95% dip in UT) for 5s
Mains power quality should be of a typical commercial or hospital environment. If the user requires continued operation during mains power interruptions, it is recommended that the product be powered from an uninterruptible power supply or a battery.
Power frequency (50/60Hz) 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 a.c. mains voltage prior to application of the test level.

 

EN 60601-1-2:2007 – Table 4 (immunity for Medical Equipment, not life-supporting)

Lumie products are intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.

Immunity Test IEC60601
Test Level
Compliance Level Electromagnetic Environment

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V
150 kHz to 80 MHz

3 V/m
80 MHz to 2.5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of Lumie product, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d = [3.5/3]√P = 1.17]√P

d = [3.5/3]√P = 1.17]√P 80 MHz to 800 MHz

d = [7/3]√P = 2.33√P 800 MHz to 2.5 GHz

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 metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey*, should be less than the compliance level in each frequency range^.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80MHz and 800MHz, 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 a Lumie product is used exceeds the applicable compliance level above, the product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary such as re-orienting or relocating the product.

^Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m

EN 60601-1-2:2007 – Table 6 (for all Medical Equipment)

Lumie products are intended for use in the electromagnetic environment specified below. The customer or the user of Lumie products can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the product as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = [3.5/3]√P
80 MHz to 800 MHz
d = [3.5/3]√P
800 MHz to 2.5 GHz
d = [7/3]√P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1.0 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33

 

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 reflection from structures, objects and people.