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 = 1,2Square root of p

d = 1,2Square root of p 80 MHz to 800 MHz3

d = 2,3Square root of p 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: Interference

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.

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

150 kHz to 80 MHz

d =1,2Square root of p

80 MHz to 800 MHz

d =1,2Square root of p

800 MHz to 2,7 GHz

d =2,3Square root of p

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.

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.
GUID-E72F728A-C9B4-4294-967D-EA17F5462A5C v4
August 2024