MDSC-8358 - EMC notice - User Guide (HTML)

6.7 EMC notice

General information

No specific requirement on the use of external cables or other accessories except power supply.

With the installation of the device, use only the delivered power supply or a spare part provided by the legal manufacturer. Using another can result in a decrease of the immunity level of the device.

Electromagnetic emissions

The MDSC-8358 is intended for use in the electromagnetic environment (IEC 60601-1-2 4^th edition) specified below. The customer or the user of the MDSC-8358 should assure that it is used in such an environment.

Emissions test	Compliance	Electromagnetic environment – Guidance
RF emissions CISPR 11	Group 1	The MDSC-8358 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 B	The MDSC-8358 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 D
Voltage fluctuations/ flicker emissions IEC 61000-3-3	Complies

This MDSC-8358 complies with appropriate medical EMC standards on emissions to, and interference from surrounding equipment. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Interference can be determined by turning the equipment off and on.

If this equipment does cause harmful interference to, or suffer from harmful interference of, surrounding equipment, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna or equipment.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced technician for help.

Electromagnetic immunity

Immunity test	IEC 60601-1-2 4^th edition (2014) Test levels	Compliance level	Electromagnetic environment – guidance
Electrostatic discharge (ESD) IEC 61000-4-2	± 8kV contact ± 15kV air	± 8kV contact ± 15kV 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	± 2kV for power supply lines ± 1kV for input/ output lines	± 2kV for power supply lines ± 1kV for input/ output lines	Mains power quality should be that of a typical commercial or hospital environment
Surge IEC61000-4-5	± 1 kV line(s) to line(s) ± 2 kV line(s) to earth	± 1 kV line(s) to line(s) ± 2 kV line(s) 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% U_T ^[1](> 95% dip in U_T) for 0.5 cycle 40% U_T (60% dip in U_T) for 5 cycles 70% U_T (30% dip in U_T) for 25 cycles < 5% U_T (>95% dip in U_T) for 5 seconds	< 5% U_T (> 95% dip in U_T) for 0.5 cycle 40% U_T (60% dip in U_T) for 5 cycles 70% U_T (30% dip in U_T) for 25 cycles < 5% U_T (>95% dip in U_T) for 5 seconds	Mains power quality should by that of a typical commercial or hospital environment. If the user of the MDSC-8358 requires continued operation during power mains interruptions, it is recommended that the MDSC-8358 be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	30 A/m	30 A/m	Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3	3 V/m (150 kHz to 80 MHz) 9 to 28 V/m in communication service channels up to 6 GHz	3 V/m (150 kHz to 80 MHz) 9 to 28 V/m in communication service channels up to 6 GHz	Portable and mobile RF communications equipment should be used no closer to any part of the MDSC-8358, 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 d = 1.2√P 80 MHz to 800 MHz d = 2.3√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 meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,^[2] should be less than the compliance level in each frequency range.^[3] Interference may occur in the vicinity of equipment marked with symbol:

Immunity test

IEC 60601-1-2 4^th edition (2014)

Test levels

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

± 8kV contact

± 15kV air

± 8kV contact

± 15kV 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

± 2kV for power supply lines

± 1kV for input/ output lines

± 2kV for power supply lines

± 1kV for input/ output lines

Mains power quality should be that of a typical commercial or hospital environment

Surge

IEC61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

± 1 kV line(s) to line(s)

± 2 kV line(s) 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% U_T ^[1](> 95% dip in U_T) for 0.5 cycle

40% U_T (60% dip in U_T) for 5 cycles

70% U_T (30% dip in U_T) for 25 cycles

< 5% U_T (>95% dip in U_T) for 5 seconds

< 5% U_T (> 95% dip in U_T) for 0.5 cycle

40% U_T (60% dip in U_T) for 5 cycles

70% U_T (30% dip in U_T) for 25 cycles

< 5% U_T (>95% dip in U_T) for 5 seconds

Mains power quality should by that of a typical commercial or hospital environment. If the user of the MDSC-8358 requires continued operation during power mains interruptions, it is recommended that the MDSC-8358 be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 V/m (150 kHz to 80 MHz)

9 to 28 V/m in communication service channels up to 6 GHz

3 V/m (150 kHz to 80 MHz)

9 to 28 V/m in communication service channels up to 6 GHz

Portable and mobile RF communications equipment should be used no closer to any part of the MDSC-8358, 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

d = 1.2√P 80 MHz to 800 MHz

d = 2.3√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 meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,^[2] should be less than the compliance level in each frequency range.^[3]

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

Note: At 80 MHz and 800 MHz, the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Recommended separation distance

The MDSC-8358 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer of the user of the MDSC-8358 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MDSC-8358 as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter ^[4] W	Separation distance according to frequency of transmitter
Rated maximum output power of transmitter ^[4] W	150kHz to 80MHz d=1.2√P	80MHz to 800MHz d=1.2√P	800MHz to 2.5GHz 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

Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection form structures, object and people.

[1] is the a.c. mains voltage prior to application of the test level.

[2] 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 MDSC-8358 is used exceeds the applicable RF compliance level above, the MDSC-8358 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MDSC-8358.

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

[4] 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.