Published on November 19, 2009
! EW N Quantify Airway Inflammation. Precisely! Managing asthma is a
The Insight™ eNO System measures exhaled nitric oxide (eNO) which offers: • Accurate measure of your patient’s degree of airway inflammation1, 2, 3 • Definitive method to titrate and optimize asthma medication4 COMPREHENSIVE • Clinical approach to identify lack of compliance5, 6 ASTHMA MANAGEMENT • Safe monitoring and prediction of asthma control5, 7, 8 With an accurate measure of your patient’s airway The Insight eNO System utilizes patented biosensor technology to make safe, accurate inflammation and customized and non-invasive measurement of nitric oxide. The Insight system’s unique, simple reports for each patient, you design features: can significantly improve the • A product designed exclusively for physician’s practice precision of your therapy • A hygienic approach that is safe for use in a multi-patient clinic setting • A long-lasting, reliable system proven for 18,000 test cycles between service intervals • Comprehensive data management and analysis for customized patient therapy • Accurate measurement of nitric oxide suitable for a broad population of asthma patients The Insight eNO System has five main components – a compact desktop monitor, an ac- curate eNO sensor, disposable breath tubes, smart patient cards, and a dedicated printer. In addition, it comes with quality control kits and carbon dioxide filters. The Insight eNO System’s biosensor is a novel, porous matrix embedded with a protein that selectively binds to nitric oxide. When a patient exhales into the device, nitric oxide in the patient’s breath sample binds with a highly selective heme-protein inside the matrix. An optical measurement of this binding gives a highly accurate nitric oxide measurement in less than a minute. 1. Frank TL, Adisesh A, Pickering AC, et al. Relationship between Exhaled Nitric Oxide and Childhood Asthma. Am J Respir Crit Care Med. 1998;158:1032-1036 2. Sergei A, Kharitonov SA, Yates DH, Barnes PJ. Inhaled Glucocorticoids Decrease Nitric Oxide in Exhaled Air of Asthmatic Patients. Am J Respir Crit Care Med. 1996;153:454-457 3. Holgate S. Mediator and Cytokine Mechanisms in Asthma. Thorax. 1993;48:103-109 4. Smith AD, Cowan JO, Brassett KP , Herbison GP, Taylor DR. Use of Exhaled Nitric Oxide Measurements to Guide Treatment in Chronic Asthma. N Engl J Med. 2005;352(21):2163-73. 5. Delgado-Corcoran C, Kissoon N, Murphy SP , Duckworth LJ. Exhaled Nitric Oxide Reflects Asthma Severity and Asthma Control. Pediatr Crit Care Med. 2004;5(1):48-52 6. Beck-Ripp J, Griese M, Arenz S, et al. Changes of Exhaled Nitric Oxide During Steroid Treatment of Childhood Asthma. Eur. Respir. J. 2002;19:1015-1019 7 Jones SL, Kittelson J, Cowan JO et al. The Predictive Value of Exhaled Nitric Oxide Measurements In . Assessing Changes In Asthma Control. Am J Respir Crit Care Med. 2001;164:738-743 8. Harkins MS, Fiato KL, Iwamoto GK. Exhaled Nitric Oxide Predicts Asthma Exacerbation. Journal of Asthma. 2004;41(4):471-476
Insight™ Monitor The Insight monitor is an easy-to-use, versatile desktop system that enables both the physician and the patient to view and interpret the results. Features Benefits Long-lasting, reliable device that can be used for Accurate, reliable measurements over time – confidence 18,000 test cycles between service intervals without the inconvenience of changing monitors regularly Easy to read and use – both the healthcare professional and the patient can see critical information simultaneously – no Large, color LCD screen with a friendly user- room for errors or confusion interface Tailored for in-clinic application; ability to interact with data and optimize analysis for efficient output Patients can get comfortable and confident before doing a real Practice mode enabled measurement - no wasted tests Precise customization of medication and therapy to individual Powerful data management and analysis, and a patients – immediate access to patient eNO history and patient- dedicated printer specific trend reports and charts Insight™ Sensor The Insight sensor is based on patented biosensor technology that uses a novel, porous matrix embedded with a protein that selectively binds to nitric oxide. Features Benefits Highly sensitive and selective to nitric oxide Accurate, reliable measurements for optimal decision-making Prevents using sensors that have already been used Smart chip coded No calibration of sensors necessary The Insight™ Breath Tube The Insight breath tube is custom designed using biocompatible material and an anti-bacterial filter to ensure patient safety and to prevent patient contamination. Features Benefits Disposable, patient-specific Custom designed using biocompatible material and an anti-bacterial filter Prevents cross-contamination between patients, promotes Patient exhales only, no patient inhalation of safety and hygiene sample required Patient handles breath tube only, no patient handling of monitor required The Insight™ Patient Card The Insight patient card provides a convenient and safe way to store and manage individual patient information. Features Benefits Patient-specific card to record and store patient Prevents mixing of patient information and enables therapy eNO information (up to 300 individual test results) customized for each patient
Product Performance Operating Conditions Accuracy Temperature 59°F – 90°F (15°C – 32°C) Analytical Accuracy (reported as differ- Nitric Oxide Conc. Accuracy Pressure 635 – 770 mm Hg (12.3 psi – 14.9 psi) ence or relative difference (%) between the Insight system and NIOX® reference ≤ 100 ppb _ 3.1 ppb + Humidity 10% - 80% relative humidity using standard gas reference samples) Continuous Operation Recommended > 100 ppb _ 3.4% of the reading + Exhalation Pressure Range 5 – 20 cm H2O (0.07 psi – 0.28 psi) Clinical Accuracy (reported as differ- Nitric Oxide Conc. Accuracy Exhalation Flow Range 45 – 55 cc/sec (compliant with ATS guidelines) ence or relative difference (%) between the Insight system and NIOX reference ≤ 50 ppb _ 3.8 ppb + Exhalation Time 11 sec in a clinical study9) 51-100 ppb _ 8.7 ppb + Sensor Initial Warm-Up Time About 5 min eNO Test Time < 1 min > 100 ppb _ 7.9% of the reading + Insight Sensor Shelf Life Up to 330 days in unopened package Precision Number of Tests/Sensor 5 or 10 Analytical Precision (repeatability of Nitric Oxide Conc. Precision Practice Mode Recommended two consecutive measurements at 20 ppb 1.5 ppb different concentrations of standard Optical measurement of the nitric oxide reaction nitric oxide gas samples) 80 ppb 2.6 ppb Measurement Technology with a highly selective heme-protein inside a 150 ppb 2.3 % patented porous matrix Clinical Precision (repeatability of two Nitric Oxide Conc. Precision Physical Description consecutive measurements each on ≤ 50 ppb 2.2 ppb Monitor Dimensions (inches) height = 6.75; width = 14.0; length = 8.5 78 asthma subjects at the same clinical site9) 51-100 ppb 5.3 ppb Weight of Insight Monitor (lbs) 8 Size of LCD Screen (inches) width = 4.5; height = 3.4 > 100 ppb 6.5 % Printer Connection USB cable Linearity (regression coefficient of a R = 0.99 2 linear fit between the Insight system Power Supply 3 amps, 110V, (50-60Hz) and NIOX reference using paired gas Electrical Data Compliant with IEC 60601-1-1, Class I Type-A sample measurement values at 9 nitric Performance Characteristics oxide concentrations over the entire measurement range) eNO Measurement Range 10-200 ppb (ppb = parts per billion) Lowest Level of Detection 10 ppb Product Configuration Description Part No. Insight™ System Kit with the following items: Insight™ Monitor (1 monitor) Insight™ Patient Card (Pack of 50 smart cards) 101095 Insight™ QC Kit (QC parts and accessories) Insight™ QC Cylinder (Nitric oxide gas container) Printer 100820 Insight™ Patient Card Pack (Pack of 50 smart cards) 100126 Insight™ Supplies Kit Insight™ Sensors (Individually safety-sealed) 101286 (50-Tests) Insight™ Breath Tubes (Individually safety-sealed) 101328 (30-Tests) Insight™ Carbon Dioxide Filters (Individually safety-sealed) 9. Based on data from 78 subjects in an in-clinic study (2008) using the Insight eNO System and the NIOX system Take your practice to the next level & elevate the standard of care for your patients Get the Insight eNO System now! Please call 1-866-550-4eNO (1-866-550-4366) 7 am - 5 pm, Monday - Friday, Pacific time. Dedicated and trained Customer Care Specialists are ready to support you. Managing asthma is a breath away™ To learn more about us or to get more information, visit us at www.apieron.com © 2009, Apieron, Inc. Insight™ is a trademark of Apieron, Inc. NIOX® is a registered trademark of Aerocrine, Inc. ML00014.E
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Title: Insight eNO System to Assist Physcians with Patient Asthma Management, ... Insight eNO System to Assist Physcians with Patient Asthma Management.
N EW ! Quantify Airway Inflammation. Precisely! Managing asthma is a The Insight™ eNO System measures exhaled nitric oxide (eNO) which offers:
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