Product Specifications
Regulatory Status
- NIOX MINO is 510(k) cleared by FDA.
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NIOX MINO is CE-marked according to In Vitro Diagnostic Device Directive 98/79/EC and approved for clinical use in EEC countries.
Operating and Measurement conditions
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| Ambient temperature: |
60 to 85° F (+16 to +30°C)
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| Atmospheric pressure range: |
10 to 15 psi (700 to 1060 hPa)
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| Humidity: |
20 to 60% RH (non-condensing) |
| Ambient NO concentration: |
< 300 ppb |
| Exhaled flow rate during measurement: |
50 mL/s ± 10% BTPS (Body Temperature Pressure Saturated, 99°F (37°C), 14.7psi (1013 hPa), 100% RH |
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Exhaled NO - Performance Data
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| Measurement range: |
5 to 300 ppb |
| Lowest detection limit: |
5 ppb |
| Exhalation time: |
10 seconds |
| Measurement time: |
< 2 min |
| Temperature stabilization time: |
≤ 30 min |
| Linerarity: |
Squared correlation coefficient r2 ≥ 0.998, slope 0.95 - 1.05, ± 3 ppb.
Determination based on the pooled regression analysis from 10 instruments using standard gas reference samples at 7 different concentration levels covering the operating measurement range. |
| Precision: |
< 3 ppb of measured value < 30 ppb
< 10 % of measured value ≥ 30 ppb
Expressed as one standard deviation for replicate measurements with the same instrument, using a certified gas concentration of Nitric Oxide reference standard
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| Accuracy: |
± 5 ppb or max 10%
Expressed as the upper 95% confidence limit, based on absolute differences for concentrations ≤ 50 ppb and relative differences for concentrations > 50 ppb, from certified gas concentration of Nitric Oxide reference standard.
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| Method comparison: |
± 5 ppb for values < 50 ppb
± 10 ppb for values 50-100 ppb
± 25 ppb for values above 100 ppb
Expressed as the difference, using one standard deviation, between a NIOX MINO measurement value and the corresponding value measured with NIOX® instrument from Aerocrine. |
| Breathing parameters: |
Inhalation
Inhalation to TLC (Total Lung Capacity) before start of exhalation, to secure proper activation:
Minimum -3 cm H2O (trigger only)
Exhalation
Exhalation time: 10 s
All exhalations are to be performed at an exhalation pressure of 10 - 20 cm H2O, to maintain a fixed flow rate of 50 ±5 mL/s.
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| Software |
Memory capacity:
3,000 measurements (instrument memory)
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Dimensions, weight and shelf-life
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| Height, Width, Depth: |
9.1" (230 mm), 5.0" (128mm), 3.8" (96 mm) |
| Weight including sensor: |
1.8 lb (0.8 kg) |
| Shelf-life: |
Instrument: Minimum 3 years at time of delivery or 3,000 measurements, whichever comes first.
Sensor: Maximum 12 months when installed in NIOX MINO or expiration date as stated on the sensor, whichever comes first. |
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| Electrical Data |
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According to IEC 60601-1 Class II Type B
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Main voltage:
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100 to 240 V ~ 50 to 60 Hz
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Secondary voltage:
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6 V DC (external power adapter)
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| Responsible Manufacturer |
Aerocrine AB, (Sundbybergsvägen 9) P.O. Box 1024, SE-171 21 Solna, Sweden |