Product Specifications

Operating Conditions

Temperature
59°F – 93°F (15°C – 34°C)
Pressure
635 – 770 mm Hg (12.3 psi – 14.9 psi)
Humidity
10% – 80% relative humidity
Continuous Operation
Recommended
Exhalation Pressure Range
5 – 20 cm H2O (0.07 psi – 0.28 psi)
Exhalation Flow Range
45 – 55 cc/s (compliant with ATS guidelines)
Exhalation Time
11 sec
Sensor Warm-Up Time
< 4 min
eNO Test Time
< 1 min
Insight Sensor Shelf Life
Up to 90 days in unopened package
Number of Tests per Sensor
One
Practice Mode
Recommended
Measurement Technology
Optical measurement of the nitric oxide reaction with a highly selective heme-protein inside a proprietary porous matrix

Physical Description

Monitor Dimensions
height = 6.75 in; width = 14.0 in; length = 9.25 in
Weight of Insight Monitor
8 lbs
Size of LCD Screen
width = 4.5 in; height = 3.4 in
Printer Connection
USB cable
Power Supply
3 amps, 110 V, (50-60 Hz)
Electrical Data
Compliant to IEC 60601-1-1, Class I Type-A

Performance Characteristics

eNO Measurement Range
10 – 200 ppb (ppb = parts per billion)
Lowest Level of Detection
10 ppb

Accuracy

Analytical Accuracy
(reported as difference or relative difference (%) between Insight system and NIOX® reference using standard gas reference samples)
Nitric Oxide Conc. Bias
≤ 100 ppb + 3.1 ppb
> 100 ppb

+ 3.4% of the reading

Precision

Analytical Precision
(repeatability of two consecutive measurements at different concentrations of standard nitric oxide gas samples)
Nitric Oxide Conc. Precision
20 ppb 1.5 ppb
80 ppb 2.6 ppb
150 ppb 2.3 %

Linearity

Linearity (regression coefficient of a linear fit between the Insight system and reference using paired gas sample measurement values at 9 nitric oxide concentrations over the entire measurement range)
R2 = 0.99
Indications for Use and Safety Information.

The intended use of the Apieron Insight™ eNO System is to quantitatively measure exhaled nitric oxide (eNO) in expired human breath as a marker of inflammation in persons with asthma. Measurement of eNO in expired human breath by the Apieron Insight eNO System is a non-invasive, simple and safe method to measure a decrease in eNO in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of the therapeutic effects in patients with elevated eNO levels.The Apieron Insight eNO System is suitable for use in children 8 to 17 years of age, and in adults 18 years of age and older. As an adjunct to established clinical assessments, such as spirometry and physical examination, eNO measurements give the physician an objective marker to evaluate the patient's response to anti-inflammatory therapy. The Apieron Insight eNO System can be used by trained operators in a physician's office or laboratory setting. The Apieron Insight eNO System should not be used in critical care, emergency care or in anesthesiology.

Federal law restricts this device to sale by or on the order of a physician.

Insight™ is a trademark of Apieron, Inc. NIOX® is a registered trademark of Aerocrine, Inc.