Appendixes

SpO2 Accuracy

70%-80%80%-90%90%-100%70%-100%
Accuracy (RMS2.71.81.62

Graphical plot

Electromagnetic Emissions-for all Equipment and Systems

Guidance and manufacture’s declaration-electromagnetic emission: The Nonagon device is intended for use in the electromagnetic environment specified below. The user of the device should assure that it is used in such an environment.

Emission TestComplianceElectromagnetic environment – guidance
RF emissions CISPR 11Group 1, Class BThe Nonagon device 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.
Harmonic emissions IEC 61000-3-2Class AThe Nonagon device is suitable for use in domestic establishments and all those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Warning: This equipment/ system is intended for use by adult lay users. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Nonagon device or shielding the location.
Voltage Fluctuations And Flicker IEC 61000-3-3:2013Complies

Electromagnetic Immunity-for all Equipment and Systems

Guidance and manufacture’s declaration – electromagnetic immunity: The Nonagon device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Immunity TestIEC 60601 test levelCompliance levelElectromagnetic environment – guidance
Conducted RF IEC 61000-4-63V, 6V
3V/m
3Vrms, 6V 3V/mPortable and mobile RF communications equipment should be used no closer to any part of the Nonagon device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 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).
Radiated RF IEC 61000-4-33V from 0.15 to 80MHz;
6V from 0.15 to 80MHz and 80% AM at 1kHz
10V/m from 80MHz to 2.7GHz
3V from 0.15 to 80MHz;
6V from 0.15 to 80MHz and 80% AM at 1kHz
10V/m from 80MHz to 2.7GHz
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. D Interference may occur in the vicinity of equipment marked with the following symbol:

N9+ System’s Essential Performance, as was declared in EMC testing, with respect to 60601-1-2:

Essential PerformanceLimits
ThermometerOutput temperature measured by the device is within accuracy limits of +/- 0.2° C
OximeterNo effect on the measured signal. A temporary* discontinuation of the measurement is acceptable.
StethoscopeNo effect on recording in the audible spectrum range. Temporary* discontinuation of recording is acceptable.
OtoscopeNo permanent image deterioration. Temporary* image deterioration or lack of image are acceptable.

*Temporary – up to 1sec

Recommended Separation Distances

Recommended separation distances between portable and mobile RF communications equipment and the Nonagon device
The Nonagon device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.
Separation distance according to frequency of transmitter
Rated maximum output power of transmitter W150 kHz to 80 MHz outside ISM bands150 kHz to 80 MHz in ISM bands80 MHz to 800 MHz800 MHz to 2,5 GHz
0.010.120.20.41
0.10.370.641.32.6
11.17248
103.76.41326
10011.7204080

Test specifications for Enclosure Port Immunity to RF wireless communications equipment

Test frequency (MHz)Band (MHz)ServiceModulationMax Power (W)DistanceTest Text Level (V/m)Compliance Level
385380 – 390TETRA 400Pulse 18 Hz1.80.32727
450430 – 470GMRS 460, FRS 460FM ±5 kHz 1 kHz sine20.32828
710704 – 787LTE Band 13, 17Pulse 217 Hz0.20.399
745
780
810800 – 960GSM 800/900; TETRA 800; iDEN 820; CDMA 850; LTE Band 5Pulse 18 Hz20.32828
870
930
1,7201700 – 1990GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTSPulse 217 Hz20.32828
1,845
1,970
2,4502400 – 2570Bluetooth; WLAN; 802.11b/g/n; RFID 2450; LTE Band 7Pulse 217 Hz20.32828
5,2405100 – 5800WLAN 802.11a/nPulse 217 Hz0.20.399
5,500
5,785

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