NEW!

Managing asthma is a breath away.

Quantify Airway Inflammation.Precisely!

The Insight™ eNO System measures exhaled nitric oxide (eNO) which offers: • Accuratemeasureofyourpatient’sdegreeofairwayinflammation1,2,3

• Definitivemethodtotitrateandoptimizeasthmamedication4

• Clinicalapproachtoidentifylackofcompliance5,6

• Safemonitoringandpredictionofasthmacontrol5,7,8

TheInsighteNOSystemutilizespatentedbiosensortechnologytomakesafe,accurateandnon-invasivemeasurementofnitricoxide.TheInsightsystem’sunique,simpledesignfeatures:

• Aproductdesignedexclusivelyforphysician’spractice

• Ahygienicapproachthatissafeforuseinamulti-patientclinicsetting

• Along-lasting,reliablesystemprovenfor18,000testcyclesbetweenserviceintervals

• Comprehensivedatamanagementandanalysisforcustomizedpatienttherapy

• Accuratemeasurementofnitricoxidesuitableforabroadpopulationofasthmapatients

TheInsighteNOSystemhasfivemaincomponents–acompactdesktopmonitor,anac-curateeNOsensor,disposablebreathtubes,smartpatientcards,andadedicatedprinter.Inaddition,itcomeswithqualitycontrolkitsandcarbondioxidefilters.TheInsighteNOSystem’sbiosensorisanovel,porousmatrixembeddedwithaproteinthatselectivelybindstonitricoxide.Whenapatientexhalesintothedevice,nitricoxideinthepatient’sbreathsamplebindswithahighlyselectiveheme-proteininsidethematrix.Anopticalmeasurementofthisbindinggivesahighlyaccuratenitricoxidemeasurementinlessthanaminute.

COMPREHENSIVE ASTHMA MANAGEMENT

With an accurate measure

of your patient’s airway

inflammation and customized

reports for each patient, you

can significantly improve the

precision of your therapy

1. FrankTL,AdiseshA,PickeringAC,etal.RelationshipbetweenExhaledNitricOxideandChildhoodAsthma.Am J Respir Crit Care Med.1998;158:1032-1036

2. SergeiA,KharitonovSA,YatesDH,BarnesPJ.InhaledGlucocorticoidsDecreaseNitricOxideinExhaledAirofAsthmaticPatients.Am J Respir Crit Care Med.1996;153:454-457

3. HolgateS.MediatorandCytokineMechanismsinAsthma.Thorax.1993;48:103-109

4. SmithAD,CowanJO,BrassettKP,HerbisonGP,TaylorDR.UseofExhaledNitricOxideMeasurementstoGuideTreatmentinChronicAsthma.N Engl J Med.2005;352(21):2163-73.

5. Delgado-CorcoranC,KissoonN,MurphySP,DuckworthLJ.ExhaledNitricOxideReflectsAsthmaSeverityandAsthmaControl.Pediatr Crit Care Med.2004;5(1):48-52

6.Beck-RippJ,GrieseM,ArenzS,etal.ChangesofExhaledNitricOxideDuringSteroidTreatmentofChildhoodAsthma. Eur. Respir. J. 2002;19:1015-1019

7. JonesSL,KittelsonJ,CowanJOetal.ThePredictiveValueofExhaledNitricOxideMeasurementsInAssessingChangesInAsthmaControl.Am J Respir Crit Care Med.2001;164:738-743

8. HarkinsMS,FiatoKL,IwamotoGK.ExhaledNitricOxidePredictsAsthmaExacerbation.Journal of Asthma. 2004;41(4):471-476

Insight™ MonitorTheInsightmonitorisaneasy-to-use,versatiledesktopsystemthatenablesboththephysicianandthepatienttoviewandinterprettheresults.

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 user-interface

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 patient-specific trend reports and charts

Insight™ SensorTheInsightsensorisbasedonpatentedbiosensortechnologythatusesanovel,porousmatrixembeddedwithaproteinthatselectivelybindstonitricoxide.

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 TubeTheInsightbreathtubeiscustomdesignedusingbiocompatiblematerialandananti-bacterialfiltertoensurepatientsafetyandtopreventpatientcontamination.

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 CardTheInsightpatientcardprovidesaconvenientandsafewaytostoreandmanageindividualpatientinformation.

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

NEW!

Product Performance

OperatingConditions

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

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

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

PhysicalDescription

Monitor Dimensions (inches) height = 6.75; width = 14.0; length = 8.5

Weight of Insight Monitor (lbs) 8

Size of LCD Screen (inches) 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

PerformanceCharacteristics

eNO Measurement Range 10-200 ppb (ppb = parts per billion)

Lowest Level of Detection 10 ppb

Accuracy

Analytical Accuracy (reported as differ-ence 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 differ-ence 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

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 %

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

Nitric Oxide Conc. Precision

≤ 50 ppb 2.2 ppb

51-100 ppb 5.3 ppb

> 100 ppb 6.5 %

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)

R2 = 0.99

Managing asthma is a breath away™

© 2009, Apieron, Inc.Insight™isatrademarkofApieron,Inc.NIOX®isaregisteredtrademarkofAerocrine,Inc. ML00014.E

Take your practice to the next level & elevate the standard of care for your patients

Get the Insight eNO System now! Pleasecall1-866-550-4eNO(1-866-550-4366)7am-5pm,Monday-Friday,Pacifictime.DedicatedandtrainedCustomerCareSpecialistsarereadytosupportyou.

To learn more about us or to get more information, visit us at www.apieron.com

Product Configuration

Description PartNo.

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. Basedondatafrom78subjectsinanin-clinicstudy(2008)usingtheInsighteNOSystemandtheNIOXsystem