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12 4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0 13 4-3-6-2 Bloom Lab IFU, 09.04.2020, V1.0
EN EN
13. Technical details
13.1. Technical specifi cations
Power supply 100-240VAC. (50/60Hz) / 5VDC, 1.5A via USB-C
Size 100x100x135mm (WxLxH)
Weight 560g
IP class IP51 (dust and dripping water protected)
Environmental
+15°C to +40°C (Measurement)
-20°C to +60°C (Storage)
<80% Relative Humidity
Communication
Bluetooth Low Energy 4.2
Module Type Class 2
NFC , ISO/IEC 14443A compliant, 106 kbps transmission rate
Firmware Version 1.1.x
End of life 5 years
Table N°4: Technical specifi cation
The Bloom Lab complies with the electromagnetic interference requirements of EN 61326-2-6:2013 and EN 61326-1:2013.
Further, it complies with the particular requirements for electromagnetic compatibility for medical devices according to EN
60601-1-2 (see Table N°5 for immunity and emission levels).
Caution: Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the Bloom Lab, including cables specifi ed by the manufac-
turer. Otherwise, degradation of the performance of this equipment could result.
The Bloom System should be used in a home or professional healthcare environment.
Emission
Test Limits
Conducted emission CISPR 11, Group 1, Class B
Radiated emission CISPR 11, Group 1, Class B
Harmonic current emission IEC 61000-3-2, Class A, power < 75W
Voltage fl uctuations and fl icker
IEC 61000-3-3
Immunity test levels
Test Test levels
Electrostatic discharge
(IEC 61000-4-2) Contact Discharge: ±8 kV
Air Discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Radiated RF EM fi elds
(IEC 61000-4-3)
80-2700 MHz; 1kHz AM 80 %; 10 V/m
Proximity fi elds from RF wireless
communications equipment
(IEC 61000-4-3)
385 MHz; Pulse Modulation: 18 Hz; 27 V/m
450 MHz; FM: ±5kHz Hub, 1 kHz Sinus; 28 V/m
710, 745, 780 MHz; Pulse Modulation: 217 Hz; 9 V/m
810, 870, 930 MHz; Pulse Modulation: 18 Hz; 28 V/m
1720, 1845, 1970 MHz; Pulse Modulation: 217 Hz; 28 V/m
2450 MHz; Pulse Modulation: 217 Hz; 28 V/m;
5240, 5500, 5785 MHz; Pulse Modulation: 217 Hz; 9 V/m
Electrical fast transients and
bursts
(IEC 61000-4-4)
Power supply lines: ±2 kV, 100kHz repetition freq.
Signal / Data lines: ±1 kV, 100kHz repetition freq.
Surge Immunity (IEC 61000-4-5)
0.5, 1,kV; Diff erential mode
Surge Waveform: Combination Wave
(2 µs x 50 µs Voltage, 8 µs x 20 µs Current)
Conducted disturbances induced
by RF fi elds (IEC 61000-4-6)
0.15-80 MHz; 1kHz AM 80 %; 3 Vrms, 6 Vrms ISM band
Rated power frequency magnetic
fi elds (IEC 61000-4-8)
30 A/m, 50 Hz / 60 Hz
Table N°5: EMI test levels
13.2. Operating principle
The Bloom Lab is an electronic device, which contains an optical measurement system (optical reader) to quantify the test
line intensities produced by the Bloom Test strip during use. It captures the Bloom Test strip read-out window, automatically
detects the test and control line and calculates the mean intensity value for each line by image analysis. This mean value,
in connection with further image analysis, corresponds to the concentration of the captured target analyte. The actual
concentration of the target analyte is calculated diff erently for each batch of Bloom Tests using the Bloom App, thus enabling
measurements with the Bloom Lab for a wide variety of analytes.