Microlife NEB Series Nebulizers: Electromagnetic Compatibility Guidance
This document outlines the electromagnetic compatibility (EMC) of the Microlife NEB 201, NEB 210, NEB 301, NEB 310, and NEB 420 nebulizer devices. It provides manufacturer declarations and guidance for ensuring proper operation in various electromagnetic environments.
Electromagnetic Emissions
The Microlife NEB series devices are intended for use in specified electromagnetic environments. Users should ensure the devices are operated within such environments to prevent interference.
RF Emissions
Test: RF emissions CISPR 11
- Compliance: Group 1
- Emissions: Class B (for NEB 201, NEB 210, NEB 301, NEB 310, NEB 420)
Guidance: The devices utilize RF energy only for their internal functions, resulting in very low RF emissions unlikely to cause interference with nearby electronic equipment. They are suitable for use in all establishments, including domestic settings and those connected to the public low-voltage power supply network.
Harmonic Emissions & Voltage Fluctuations
Test: Harmonic emissions IEC 61000-3-2, Voltage fluctuations/flicker emissions IEC 61000-3-3
- Compliance: Class A
Guidance: Mains power quality should be typical of a commercial or hospital environment.
Electromagnetic Immunity
The following immunity tests and compliance levels are specified for the Microlife NEB series:
| Immunity Test | IEC 60601 Test Level | Compliance Level | Electromagnetic Environment - Guidance |
|---|---|---|---|
| Electrostatic discharge (ESD) IEC 61000-4-2 | +8 kV contact, ±15 kV air | +8 kV contact, ±15 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 | Power supply lines: ±2 kV, input/output lines: ±1 kV | Power supply lines: ±2 kV, line(s) to line(s) ±1 kV, line(s) to earth ±2 kV | Mains power quality should be that of a typical commercial or hospital environment. |
| Surge IEC 61000-4-5 | 100 kHz repetition frequency | 100 kHz repetition frequency | 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 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 that of a typical commercial or hospital environment. |
| Power frequency (50/60Hz) magnetic field IEC 61000-4-8 | 30 A/m, 50Hz/60Hz | 30 A/m, 50Hz/60Hz | Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. |
Conducted RF Immunity
Test: Conducted RF IEC61000-4-6
- Test Level: 150 kHz to 80 MHz: 3 Vrms; 6 Vrms (in ISM and amateur radio bands); 80% AM at 1 kHz
- Compliance Level: 150 kHz to 80 MHz: 3 Vrms; 6 Vrms (in ISM and amateur radio bands); 80% AM at 1 kHz
Radiated RF Immunity
Test: Radiated RF IEC61000-4-3
- Test Level: 10 V/m
- Compliance Level: 10 V/m
Guidance for RF Communications: Portable and mobile RF communications equipment should be used at a distance from the NEB devices, calculated based on the transmitter's maximum output power and frequency. The recommended separation distance 'd' in meters can be estimated using the formula: d = 1.2/√P for 80 MHz to 800 MHz and d = 2.3/√P for 800 MHz to 2.5 GHz, where P is the maximum output power of the transmitter in watts.
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. For fixed transmitters, an electromagnetic site survey should be considered. If measured field strength exceeds the compliance level, observe the device for normal operation and consider re-orienting or relocating if abnormal performance occurs.
Note 3: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended Separation Distances for RF Communications Equipment
The following table provides recommended separation distances based on transmitter frequency and output power:
| Transmitter Rated Maximum Output Power (W) | Separation distance according to frequency of transmitter (m) | ||||||
|---|---|---|---|---|---|---|---|
| 150 kHz to 80 MHz | 80 MHz to 800 MHz | 800 MHz to 2.5 GHz | |||||
| d=1.2/√P | d=1.2/√P | 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: For transmitters rated at a maximum output power not listed above, the recommended separation distance 'd' in meters 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.
Detailed RF Immunity Table
The following table specifies immunity test levels for various RF communication systems:
| Immunity Test | Test Band (MHz) | Frequency (MHz) | Service | Modulation | Distance (m) | IMMUNITY TEST LEVEL (V/m) |
|---|---|---|---|---|---|---|
| Radiated RF IEC61000-4-3 | 385 | 380 to 390 | TETRA 400 | Pulse modulation 18 Hz | 1.8 | 27 |
| 450 | 430 to 470 | GMRS 460, FRS 460 | FM ± 5 kHz deviation, 1 kHz sine | 2 | 28 | |
| 710 | 704 to 787 | LTE Band 13, 745 | Pulse modulation | 0.2 | 9 | |
| 780 | 800 | GSM 800/900, TETRA 800, Iden 820, CDMA 850, LTE Band 5 | Pulse modulation 217 Hz | 2 | 28 | |
| 870 | 870 | |||||
| 930 | 930 | |||||
| 1720 | 1700 to 1990 | GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS | Pulse modulation 217 Hz | 2 | 28 | |
| 1845 | 1845 | |||||
| 1970 | 1970 | |||||
| 2450 | 2400 to 2570 | Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | Pulse modulation 217 Hz | 2 | 28 | |
| 5240 | 5100 to 5800 | WLAN 802.11 a/n | Pulse modulation 217 Hz | 0.2 | 9 | |
| 5500 | 5500 | |||||
| 5785 | 5785 |
Note: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. This 1 m test distance is permitted by IEC 61000-4-3.
Note: For some services, only the uplink frequencies are included. The carrier should be modulated using a 50% duty cycle square wave signal. As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used as it represents a worst-case scenario.
Manufacturers should consider reducing the minimum separation distance based on RISK MANAGEMENT and using higher IMMUNITY TEST LEVELS. Minimum separation distances for higher IMMUNITY TEST LEVELS can be calculated using the equation: d = √P * E / 3, where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY TEST LEVEL in V/m.
