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FeNO monitoring system Vivatmo me

FeNO monitoring system Vivatmo me

FeNO monitoring system Vivatmo me

Product catalog summary
Features
The Vivatmo me device measures nitric oxide levels in the range of 5 ppb to 300 ppb with high linearity (r² ≥ 0.99) and accuracy. It is designed for up to 1,000 measurements and has a memory capacity for the same number. The device is suitable for children aged 7-11 who cannot complete a 10-second measurement.

Limitations
The device should be exchanged no later than three years after the manufacturing date.

REACH Regulation
The product contains lead monoxide in its pump, as per Article 33 of the REACH Regulation No. 1907/2006.

Specifications
The device includes a disposable mouthpiece with a shelf life of two years and a handheld sensor using a chemical field-effect transistor. It operates on 4 AAA batteries, with a weight of 170 g and dimensions of 4.0 cm x 5.4 cm x 22.4 cm.

Environmental Specifications
Operational temperature ranges from +15 °C to +27 °C, with storage conditions between +5 °C to +27 °C. The device operates under relative humidity of 15% to 60% and air pressure from 780 hPa to 1,100 hPa.

Electromagnetic Compatibility (EMC)
The device complies with EN60601-1-2:2015 standards for EMC, ensuring immunity against electromagnetic interferences. It should not be used near strong electromagnetic fields, and portable RF devices should maintain a distance of at least 30 cm.

Electromagnetic Emissions and Immunity
The Vivatmo me emits low RF energy and is suitable for use in domestic environments. It complies with various IEC standards for immunity against electrostatic discharge, power frequency magnetic fields, and radiated RF.

Test Specifications
The device has been tested for immunity against high-frequency radio-based electronic communications systems across various frequencies and modulation types.
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Catalog excerpts

FeNO monitoring system Vivatmo me-1

1|4 Vivatmo me – Data Sheet F 09G 100 196_08 FeNO monitoring system Sensor Chemical field-effect transistor Display Digital LCD display Vivatmo me 4 AAA batteries 1.5 V, Power source FEATURES Useful life of alkaline longlife batteries limited to up to 25 purge processes battery: accessory; Compartment lid: detach. part Package contents Measuring range Vivatmo me device, 5 ppb to 300 ppb 5 disposable mouthpieces, batteries, protective r² ≥ 0.99, slope 1.00 ± 0.05, cap, Instructions for Use intercept ± 5 ppb ±5 ppb below 50 ppb, ±10 % ≥50 ppb, ±15 % ≥ 160 ppb expressed as the upper/lower confidence limit of 95 % ±5 ppb below 50 ppb, ±10 % ≥50 ppb, ±15 % ≥ 160 ppb expressed as one standard deviation for replicate measurements with the same instrument Lifetime, Device service life Memory capacity 6 seconds measurement mode For children ages 7 – 11 years old who are not able to complete a 10 second measurement mode Limitations of the System: Exchange your Vivatmo me at the latest 3 years after manufacturing date. Disposable Mouthpiece (accessory) Single use Measurement within 15 minutes after opening the pouch. Useful life limited to 5 attempts and expiration date. Shelf life 2 years from manufacturing. Handheld Sensor Chemical field-effect transistor Power source 4 AAA batteries 1.5 V, Useful life of batteries: Alkalin up to 25 attempts, lithium/ iron disulfide up to 60 attempts 170 g Package contents Vivatmo me device, package of 5 disposable mouthpieces, 4 AAA batteries, protective cap, Instructions for use REACH REGULATION Reporting Requirement according to Article 33 of the REACH Regulation No. 1907/2006: The pump within our product contains lead monoxide. Data subject to change without notice | Printed in Germany | March 2022 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 7133

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FeNO monitoring system Vivatmo me-2

Vivatmo me - Data Sheet F 09G 100 196 08 ENVIRONMENTAL SPECIFICATIONS Data subject to change without notice | Printed in Germany | March 2022 Bosch Healthcare Solutions GmbH Stuttgarter StraBe 130 71332 Waiblingen, Germany

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FeNO monitoring system Vivatmo me-3

Vivatmo me - Data Sheet F 09G 100 196 08 Guidance and manufacturer’s declaration - electromagnetic immunity The Vivatmo me is intended for use in the electromagnetic environment specified below. The customer or the user of the Vivatmo me should assure that it is used in such an environment. Immunity test IEC 60601 Test Compliance level Electromagnetic environment - Guidance level Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete or ceramic tile. If floors are discharge (ESD) ±15 kV air ±15 kV air covered with synthetic material, the relative humidity should be interruptions...

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FeNO monitoring system Vivatmo me-4

Vivatmo me – Data Sheet F 09G 100 196_08 Test specifications for immunity test against high-frequent radio-based electronic communications systems Test frequency MHz 385 450 710 745 780 810 870 930 1720 1845 1970 Modulation b Pulse modulation b 18 MHz FM ± 5 kHz Deviation 1 kHz Sine Pulse modulation b 217 MHz Immunity testing level V/m 27 The carrier must be modulated by a square-wave signal with a duty cycle of 50%. Data subject to change without notice | Printed in Germany | March 2022 Bosch Healthcare Solutions GmbH Stuttgarter Straße 130 71332 Waiblingen, German

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