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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

COMPREHENSIVE ASTHMA MANAGEMENT

• Definitive method to titrate and optimize asthma medication4 • Clinical approach to identify lack of compliance5, 6 • Safe monitoring and prediction of asthma control5, 7, 8

With an accurate measure of your patient’s airway reports for each patient, you

The Insight eNO System utilizes patented biosensor technology to make safe, accurate and non-invasive measurement of nitric oxide. The Insight system’s unique, simple 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

inflammation and customized

• 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 accurate 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 18,000 test cycles between service intervals

Accurate, reliable measurements over time – confidence without the inconvenience of changing monitors regularly

Large, color LCD screen with a friendly userinterface

Easy to read and use – both the healthcare professional and the patient can see critical information simultaneously – no room for errors or confusion Tailored for in-clinic application; ability to interact with data and optimize analysis for efficient output

Practice mode enabled

Patients can get comfortable and confident before doing a real measurement - no wasted tests

Powerful data management and analysis, and a dedicated printer

Precise customization of medication and therapy to individual patients – immediate access to patient eNO history and patientspecific 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

Smart chip coded

Prevents using sensors that have already been used 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 Patient exhales only, no patient inhalation of sample required Patient handles breath tube only, no patient handling of monitor required

Prevents cross-contamination between patients, promotes safety and hygiene

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 eNO information (up to 300 individual test results)

Prevents mixing of patient information and enables therapy customized for each patient


Product Performance Operating Conditions

Accuracy

Temperature

59°F – 90°F (15°C – 32°C)

Pressure

635 – 770 mm Hg (12.3 psi – 14.9 psi)

Humidity

10% - 80% relative humidity

Continuous Operation

Recommended

Analytical Accuracy (reported as difference or relative difference (%) between the Insight system and NIOX® reference using standard gas reference samples)

Nitric Oxide Conc.

Accuracy

≤ 100 ppb

_+ 3.1 ppb

> 100 ppb

_+ 3.4% of the reading

Clinical Accuracy (reported as difference or relative difference (%) between the Insight system and NIOX reference in a clinical study9)

Nitric Oxide Conc.

Accuracy

≤ 50 ppb

_+ 3.8 ppb

51-100 ppb

_+ 8.7 ppb

> 100 ppb

_+ 7.9% of the reading

Nitric Oxide Conc.

Precision

20 ppb

1.5 ppb

80 ppb

2.6 ppb

Exhalation Pressure Range

5 – 20 cm H2O (0.07 psi – 0.28 psi)

Exhalation Flow Range

45 – 55 cc/sec (compliant with ATS guidelines)

Exhalation Time

11 sec

Sensor Initial Warm-Up Time

About 5 min

eNO Test Time

< 1 min

Insight Sensor Shelf Life

Up to 330 days in unopened package

Precision

Number of Tests/Sensor

5 or 10

Practice Mode

Recommended

Measurement Technology

Optical measurement of the nitric oxide reaction with a highly selective heme-protein inside a patented porous matrix

Analytical Precision (repeatability of two consecutive measurements at different concentrations of standard nitric oxide gas samples)

Physical Description Monitor Dimensions (inches)

height = 6.75; width = 14.0; length = 8.5

Weight of Insight Monitor (lbs)

8

Size of LCD Screen (inches)

Clinical Precision (repeatability of two consecutive measurements each on 78 asthma subjects at the same clinical site9)

width = 4.5; height = 3.4

Printer Connection

USB cable

Power Supply

3 amps, 110V, (50-60Hz)

Electrical Data

Compliant with 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

Linearity (regression coefficient of a linear fit between the Insight system and NIOX reference using paired gas sample measurement values at 9 nitric oxide concentrations over the entire measurement range)

150 ppb

2.3 %

Nitric Oxide Conc.

Precision

≤ 50 ppb

2.2 ppb

51-100 ppb

5.3 ppb

> 100 ppb

6.5 %

R = 0.99 2

Product Configuration Description

Part No.

Insight™ System Kit with the following items: Insight™ Monitor (1 monitor) Insight™ Patient Card (Pack of 50 smart cards) Insight™ QC Kit (QC parts and accessories) Insight™ QC Cylinder (Nitric oxide gas container)

101095

Printer

100820

Insight™ Patient Card Pack (Pack of 50 smart cards)

100126

Insight™ Supplies Kit Insight™ Sensors (Individually safety-sealed) Insight™ Breath Tubes (Individually safety-sealed) Insight™ Carbon Dioxide Filters (Individually safety-sealed)

101286 (50-Tests) 101328 (30-Tests)

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


Insight eNO System to Assist Physcians with Patient Asthma Management  

The Insight eNO System utilizes patented biosensor technology to make safe, accurate and non-invasive measurement of nitric oxide.

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