Declaration - Electromagnetic Emissions and Immunity

For equipment and systems that are not life-supporting and are specified for use only in a shielded location. 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. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the unit, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

The Index™ BPM device is intended for use in the electromagnetic environment specified in the following table. The customer or the user of the Index BPM device 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	Contact: ±8 kV Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV	Contact: ±8 kV Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV	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	N/A¹	Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5	+ 0.5kV, +1kV line(s) to line(s) +0.5kV, +1kV,+ 2kV line(s) to earth	N/A	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	Voltage dips: 0 % UT; 0,5 cycle 0 % UT; 1 cycle 70 % UT; 25/30 cycles Voltage interruptions: 0 % UT; 250/300 cycles	Voltage dips: N/A	Mains power quality should be that of a typical commercial or hospital environment. If the user of the Index BPM requires continued operation during power mains interruptions, it is recommended that the Index BPM be powered from an uninterruptible power supply or a battery.
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8	30 A/m 50 Hz or 60 Hz	30 A/m 50 Hz and 60 Hz	The Index BPM power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

The Index BPM device is intended for use in the electromagnetic environment specified in the following table. The customer or the user of the Index BPM device should assure that it is used in such an environment.

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


Immunity Test	IEC 60601 Test Level	Compliance Level	Electromagnetic Environment - Guidance
Conducted RFIEC 61000-4-6	3 Vrms 150 kHz to 80 MHz 6 Vrms: In ISM and amateur radio bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz	N/A²	Portable and mobile RF communications equipment should be used no closer to any part of the INDEX BPM, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Radiated RF IEC 61000-4-3	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	Recommended separation distance: d = 1,2 d = 1,2 80 MHz to 800 MHz³ d = 2,3 800 MHz to 2,7 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). Interference may occur in the vicinity of equipment marked with the following symbol:

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

1. Recommended separation distance between portable and mobile RF communications equipment and the Index BPM
Rated maximum output power of transmitter W	Separation distance according to frequency of transmitter m
Rated maximum output power of transmitter W	150 kHz to 80 MHz d =1,2	80 MHz to 800 MHz d =1,2	800 MHz to 2,7 GHz d =2,3
0,01	N/A	0,12	0,23
0,1	N/A	0,38	0,73
1	N/A	1,2	2,3
10	N/A	3,8	7,3
100	N/A	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: 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 from structures, objects and people.

The Index BPM is intended for use in the electromagnetic environment (for home healthcare) specified in the following table. The customer or the user of the Index BPM should assure that it is used in such an environment.

2. Manufacturer's declaration-electromagnetic immunity test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment
Test frequency (MHz)	Band (MHz)	Service	Modulation	Maximum power (W)	Distance (m)	IMMUNITY TEST LEVEL (V/m)	Compliance level (V/m for home healthcare)
385	380-390	TETRA 400	Pulse modulation 18 Hz	1,8	0,3	27	27
450	430-470	GMRS 460, FRS 460	FM⁴ ±5 kHz deviation 1kHz sine	2	0,3	28	28
710	704-470	LTE Band 13,17	Pulse modulation 217 Hz	0,2	0,3	9	9
745
780
810	800-960	GSM 800/900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5	pulse modulation 18 Hz	2	0,3	28	28
870
930
1 720	1 700-1 990	GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1, 2, 3, 4, 25 UMTS	Pulse modulation 217 Hz	2	0,3	28	28
1 845
1 970
2 450	2 400-2 570	Bluetooth, WLAN, 802.11 b/g/n, RFID, 2450, LTE Band 7	Pulse modulation 217 Hz	2	0,3	28	28
5 240	5 100-5 800	WLAN 802.11 a/n	Pulse modulation 217 Hz	0,2	0,3	9	9
5 500
5 785
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. The 1 m test distance is permitted by IEC 61000-4-3. NOTE: For some services, only the uplink frequencies are included. NOTE: The carrier shall be modulated using a 50% duty cycle square wave signal.

¹ Not Applicable. The Index BPM is battery-powered, not AC powered.

² Not Applicable. The EUT is operating by battery, no supply for AC mains.

³ At 80 MHz and 800 MHz, the higher frequency range applies.

⁴ As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

Index™ BPM

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Declaration - Electromagnetic Emissions and Immunity