lab679 smokerlyzer manual - issue 4 - bedfont · the cut-off point between smoker and non-smoker...

Smokerlyzer® RangeFor use with piCOTM, piCObabyTM and Micro+TM

User manual

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Our family, innovating health, for yours.

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ily,innovatinghealth,foryours.

Contents

Intendeduse.......................................................................................................................................2

Introduction........................................................................................................................................2

Takingabreathtest............................................................................................................................2

Conductinganambienttest–Micro+™only......................................................................................3

Reviewinghistory–Micro+™only......................................................................................................3

Changingdateandtime–Micro+™only............................................................................................3

Trafficlightpre-setcut-offlevels.......................................................................................................4

Technicalspecification.......................................................................................................................4

Safetyinformationanddevicesymbols.............................................................................................5

Environment.......................................................................................................................................6

Instrumentlayout...............................................................................................................................7

Displayanddevicesymbols................................................................................................................8

Warningsandmaintenance.............................................................................................................10

Cleaning............................................................................................................................................11

Routinemaintenance.......................................................................................................................11

Troubleshooting...............................................................................................................................11

COdata+™software–connectingtothePC.....................................................................................13

Returnsprocedure...........................................................................................................................13

Spares...............................................................................................................................................14

Warranty..........................................................................................................................................14

References........................................................................................................................................14

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IntendeduseThepiCO™,piCObaby™andMicro+™Smokerlyzer®productsarebreathcarbonmonoxidemonitorsintendedformulti-patientusebyhealthcareprofessionalsinsmokingcessationprogrammesandresearch.Theycanalsobeusedasanindicatorofcarbonmonoxidepoisoninginahealthcareenvironment.

IntroductionCarbonmonoxide(CO)isatoxic,odourless,colourlessandtastelessgas1.Itisformedbytheincompletecombustionoforganicmaterialathightemperatures,withaninsufficientoxygensupply.

Wheninhaled,COdisplacesoxygeninthebloodstreamtoformcarboxyhaemoglobin(COHb).Thisstarvesbodytissueofoxygenrestrictingthebody’sperformanceandcausinghealthimplications2.COcanremaininthebloodstreamforupto24hours,dependingonfactorssuchasphysicalactivity,sex,andinhalationintensity.Thehalf-lifeisabout5hours3.

CO(ppm),carboxyhaemoglobin(%COHb)andfoetalcarboxyhaemoglobin(%FCOHb)correlation:Breathcarbonmonoxideismeasuredinpartspermillion(ppm)andbloodcarboxyhaemoglobinismeasuredinpercentages(%COHband%FCOHb)4.Thethreearecompatibleandconvertible:theppmCOreadingrelatestogasinthelungsandonthebreath(i.e.theamountofpoisonousCOthathasbeeninhaled),andthe%COHband%FCOHbreadingsrelatetothepercentageofvitaloxygenthathasbeenreplacedinthebloodstream4.

ThepiCO™Smokerlyzer®displaysbothCOppmand%COHb,thepiCObaby™Smokerlyzer®displaysbothCOppm,%FCOHband%COHbandtheMicro+™Smokerlyzer®displaysCOppm,%COHband%FCOHb.HoweveralldevicesonlydirectlymeasureCOppm,the%COHband%FCOHbisacalculationbasedonclinicalevidence.Clinicalresearchhasdemonstratedthatausefulrelationshipbetweencarbonmonoxideandcarboxyhaemoglobinisobtainedafterashortperiodofbreath-holding.

Thecut-offpointbetweensmokerandnon-smokerdiffersbasedonlocalregulation,Bedfont®havecreatedcut-offlevelsasaguideonly,see‘trafficlightpre-setcut-offlevels’,thesecanbealteredin-linewithyourlocalregulationsfromthesettingsscreen.

Takingabreathtest1. AttachabreathsamplingD-piece™andnewSteriBreath™mouthpiece2. Turnonthemonitorbypressingthepowerbuttononce

3. Press‘breathtest’symbolonscreen, or

4. Tocancelthebreathtest,press 5. Inhaleandholdbreathforthepre-set15secondcountdown6. Abeepwillsoundduringthelastthreesecondsofthecountdown.7. Blowslowlyintomouthpiece,aimingtoemptylungscompletely

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8. Theppmandequivalent%COHband/or%FCOHblevelswillriseandholdonscreen.

9. OnthepiCO™andpiCObaby™,whenthetestisfinished willappearatthebottomofthescreen

10. OntheMicro+™,whenthetestisfinished willappearatthebottomofthescreen

11. Ifahighreadinghasbeenrecorded,youcanmutethesoundbypressing

12. Torepeatbreathtest,press oncetoreturntothehomescreenandrepeatsteps3-8

13. Tosavethereading(Micro+™only)press andselecttherelevantpatientprofile14. RemovetheD-piece™betweenteststopurgesensorwithfreshair15. Toswitchoff,pressandholdthepowerbuttonfor3seconds,unitwillalsopoweroffafter2

minutesofinactivitytosavepower.

Conductinganambienttest–Micro+™onlyTheenvironmentalaircanbetestedtocheckforCOintheenvironmentusingtheMicro+™Smokerlyzer®.Thisisparticularlyusefulintheeventofapatientreportinganon-smokerstatusbutprovidingabreathreadingofthatofasmokersuggestingtheyhaveinhaledenvironmentalCO.

Thisiscarriedoutbypressing onthescreen;theMicro+™willthencarryoutreal-time

monitoringoftheenvironmentalair.Tostopthetest,press .

Bedfont®doesnotrecommendthattheenvironmentaltestaloneisusedasameasureofpassivesmokingastheveryhighdispersivenessofCOatthelevelsinvolvedwithsmokingcanleadtofalsenegativereadings.

Reviewinghistory–Micro+™only

TheMicro+™willrecordeveryreadingtakeninitshistoryupto150readings,toaccessthispress

andthen thehistorywillthenbeshown.

Changingdateandtime–Micro+™only

Press andthen youcanthenselecteitherd-m-yorm-d-yforthedateformatand12hor24hforthetimeformat.Datesandtimesarethenadjustedbyselectingthenumberyouwishto

changeandpressing or toincreaseanddecrease.Press tosaveyoursettings.

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Trafficlightpre-setcut-offlevelsTrafficlightcolour Description Reading(ppm)

piCO™&Micro+™ piCObaby™Green Non-smoker 0-6 0-3Amber Borderline 7-9 4-61Red Smoker–lowaddicted 10-15 7-102Red Smoker–moderatelyaddicted 16-25 11-153Red Smoker–heavilyaddicted 26-35 16-253RedFlashing Smoker–veryheavyaddicted 36+ 26+

Toadjustthepre-setcutofflevels,press fromthesettingsmenuanddragthecutofflevelsupanddowntothedesiredppmlevel.Thesesettingswillremainuntiladjustedagain.

Technicalspecification piCO™ piCObaby™ Micro+™

Concentrationrange 0-150ppm 0-150ppm 0-500ppmDisplay FullcolourtouchscreenDetectionprinciple ElectrochemicalsensorRepeatability <±5%Accuracy 2ppm/5%*Power 3xAA(LR6orequivalent)–upto1000minutes

1xCR2032LithiumcoincellT90responsetime <30secondsOperatingtemperature 15-40°CStorage/transporttemperature 0-50°COperating/storage/transportpressure Atmospheric±10%Operatinghumidity 15-90%RH(non-condensing)Storage/transporthumidity 0-95%RH(non-condensing)Sensoroperatinglife 5yearsSensorsensitivity 1ppmSensordrift <5%perannumDimensions Approx.37x77x140mmWeight Approx.215g(includingbatteries)Materials Case:polycarbonate/ABSblend

SteriTouch®anti-microbialadditiveD-piece™:polypropyleneSteriBreath™:polypropylene

H2crossinterference ≤6%*whicheverisgreater

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SafetyinformationanddevicesymbolsDegreeofprotectionagainstelectricshock TypeBFappliedpartTypeofprotectionagainstelectricshock InternallypoweredequipmentDegreeofprotectionagainstingressofliquid IPXO-notprotectedagainstwateringressDegreeofsafetyapplicationinthepresenceofaflammableanaestheticmixturewithair,oxygenornitrousoxide

Equipmentnotsuitableforuseinthepresenceofflammablemixtures.

Refertomanual

Directcurrent

CEmark

TypeBFappliedpart

DisposeofaccordingtoWEEE

Serialnumber

Manufacturebyanddate

Bedfont®logo

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EnvironmentThepiCO™,piCObaby™andMicro+™Smokerlyzer®products

complywiththedirectiveEN60601-1-2

electromagneticcompatibilitybutcanbeaffectedbycellularphonesandbyelectromagneticinterferenceexceedingthelevelsspecifiedinEN50082:1.Thisequipmentshouldbemovedifnecessarytoavoidinterference.

Guidanceandmanufacturer’sdeclaration:ElectromagneticImmunity(IEC60601-1-2)

TheSmokerlyzer®monitorsareintendedfortheuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheSmokerlyzer®shouldassurethatitisusedinsuchanenvironment.

Immunitytest IEC60601Testlevel Compliancelevel Electromagneticenvironment–guidance

RadiatedEmissionsEN55011:2007

30MHzto1GHz Metorexceeded

RadiatedImmunityEN61000-4-3:2006+A1:2008+IS12009+A2:2010

10V/m(1kHz80%)80MHz–2.7GHz385MHz27V/mPM18Hz450MHz28V/mFM1kHzsine710MHz9V/mPM217Hz745MHz9V/mPM217Hz780MHz9V/mPM217Hz810MHz28V/mPM18Hz870MHz28V/mPM18Hz930MHz28V/mPM18Hz1720MHz28V/mPM217Hz1845MHz28V/mPM217Hz1970MHz28V/mPM217Hz2450MHz28V/mPM217Hz5240MHz9V/mPM217Hz5500MHz9V/mPM217Hz5785MHz9V/mPM217Hz

Metorexceeded Interferencemayoccurinthevicinityofequipmentmarkedwiththefollowingsymbol:

PowerFrequencyMagneticImmunityEN61000-4-8:2010

30A/mmagneticallysensitiveequipment

Metorexceeded

ESDEN61000-4-2:1995+A1+A2

8kVcontact2,4,8,15kVair Metorexceeded

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Instrumentlayout

1. Display2. Powerbutton3. BreathsamplingD-piece™4. D-piece™aperture5. Exhaustportforbreathsample6. USBconnector

(forusewithCOdata+™software)7. Single-useSteriBreath™mouthpiece8. Batterycompartment9. Batterycompartmentclip10. Resetbutton11. Programmingswitch

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DisplayanddevicesymbolsDescription piCO™ piCObaby™ Micro+™Batterycondition:full

Batterycondition:low

Batterycondition:empty

Breathtest

Environmentaltest N/A N/A

Settings

Patientprofiles

N/A N/A

ViewpatientresultsN/A N/A

Inhale

Holdbreath

Countdowntimer

Exhale

ppmreading

%COHbreading

Show%FCOHb

N/A

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Description piCO™ piCObaby™ Micro+™%FCOHbreading

N/A

AmbientCOreading

N/A N/A

Home

ChangeD-piece™

Changetrafficlightcut-offlevels

Save

N/A N/A

Changebreath-holdtime

N/A N/A

History

N/A N/A

Mute

Nextstep

Lowtemperature

Hightemperature

Countdowntosensorchange

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Changesensor

Calibratedevice

Description piCO™ piCObaby™ Micro+™Attachflowmetertogascanister

AttachcalibrationadaptortoD-piece™

AttachD-piece™tomonitorandturnongasflow

Unitcalibrating

Calibrationsuccessful

Calibrationfailed

Retrycalibration

Firmwareversion N/A=NotAvailableonthisdevice

Warningsandmaintenance1. Mouthpiecesshouldbereplacedaftereveryuse.2. Handsshouldbewashedregularlyinaccordancewithinfectioncontrolpractice.3. Pleasedonotattempttomodifytheequipmentinanywayoruseaccessoriesnotspecified

bythemanufacturer.Anyattempttodosowillinvalidatethewarrantyandmaycompromisethesafetyofthedevice.

4. Bedfont®willmakeavailableuponrequestservicetrainingtoappropriatelyqualifiedpersons.

5. Holdingtheresetbuttondownfor30secondswillperformcompletedevicereset,thiswillclearanysaveddataandrevertallsettingstothefactorydefaults.Afterperformingaresetthedevicewillneedtohavethedate/timesetandbecalibratedbeforeitcanbeused.

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Cleaning1. TheSmokerlyzer®productsaremouldedwithSteriTouch®technologyforoptimuminfection

controlandbacterialefficacy.HoweverBedfont®recommendswipingtheinstrumentandD-piece™externalsurfaceswithaproductspecificallydevelopedforthispurpose.Bedfont®providesinstrumentcleaningwipes.TheD-piece™cannotbesterilised.

2. NEVERusealcoholorcleaningagentscontainingalcoholorotherorganicsolventsaslongtermexposuretothesevapourswilldamagetheCOsensorinside.

3. Undernocircumstancesshouldtheinstrumentbeimmersedinliquidorsplashedwithliquid.

Routinemaintenance1. Replacebatterieswhenindicatedbytheemptysymbol . 2. Bedfont®recommendremovalofthebatterieswhenthedeviceisnotusedforprolonged

periodsoftimetopreventleakage.3. ReplacebreathsamplingD-piece™every30daysorifvisiblysoiledorcontaminated.The

piCO™,piCObaby™andMicro+™Smokerlyzer®productswillgiveareminderduringstart-upwhentheD-piece™shouldbereplaced,see‘changeD-piece™’symbol.

4. Thesensorshouldbereplacedevery5years,60dayspriortothesensorchange‘countdowntosensorchange’symbolwillbeshownwiththedateonwhichthesensorshouldbe

changed.Thiscanbeignoredbypressing untilthedateatwhichthesensorshouldbechangedarrives,atthispointthe‘changesensor’symbolwillbeshown.ChangesensoriftrainedtobyanapprovedBedfont®engineerorsendtoBedfont®orthelocalrepresentative.

5. Additionaltechnicalinformationcanbemadeavailableonrequest;pleasecontactBedfont®oritsdistributor.

TroubleshootingTheunitfailstoturnon:

Iftheunitfailstoturnonproperly,checkifthelow or emptybatterysymbolsareshownorreplacethebatteries.Ensurethatthebatteriesareinsertedthecorrectwayaround,matchingthesymbolsmouldedintotheplastic.

Highreadingsrecordedforreportednon-smoker:Ifabreathtestonanon-smokergivesanindicationofCObeingpresent,itmayindicatethefollowing:

1. AhighambientlevelofCO(possiblyduetoafaultycombustionapplianceorexhaustfumes).2. Theeffectsofpassivesmoking.3. Thedeviceiscontaminatedbyalcoholoranotherorganicsubstance.

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4. Thepatientmayhaveaveryhighlevelofhydrogenontheirbreath,whichcanbegeneratedinthehumandigestivesystem.

5. Thesensormayhavedriftedoutofspecification(seebelow).

Thesensorhasdriftedoutofspecification:Smokerlyzer®productsarecalibratedbeforeleavingBedfont®,howeverwerecommendifyoususpecttheinstrumentisreadingincorrectly,trythetestagainwithanotherdeviceifavailabletogetacomparison.AlternativelyyoucheckthefunctionusingBedfont®checkgasorsendbacktoBedfont®.ThecheckgasrequiredisBedfont®20ppmcarbonmonoxideinair,procedurebelow.

1. Ensurethefinecontrolvalveisintheoffposition.2. Screwthefinecontrolvalveandflowindicatorassemblytothegascan.Thisisbestdoneby

screwingthegascanintothevalve.

3. Press‘breathtest’symbolonscreen, or ,tostartabreathtest.

4. Whenpromptedbythe‘exhale’symbol, or ,openthefinecontrolvalveorregulatorandallowthegastoflowat1litreperminute.

5. Allowthegastoflowthroughtheinstrumentforthedurationofthetest,againmonitoringtherateofflow.

6. Ifthefinaldisplayedvalueislessthan15ppmorhigherthan25ppm,stopthetestandperformacalibrationorsendbacktoBedfont®forafreeofchargecalibration,followingtheinstructionsbelow.

Calibrationprocedure:

1. Turnonthemonitorbypressingthepowerbuttononce

2. Press

3. Startthecalibrationprocess,pressingthe symbol5timesandthen oncetoproceed

4. Ifthetemperatureofthemonitoristoolowtocalibrate,thebluethermometerwillbe

shown .Tryagainlateroncetheunithaswarmedup–ifthisproblempersistspleasecontactBedfont®oryourlocalsupplier.

5. Ifthetemperatureofthemonitoristoohightocalibrate,theredthermometerwillbe

shown .Tryagainlateroncetheunithascooleddown–ifthisproblempersistspleasecontactBedfont®oryourlocalsupplier.

6. Oncethishasbeensuccessfullycarriedoutthedevicewillperformazero;donotapplygasatthisstage

7. Thefirststepofthecalibrationprocesswillbeshownonscreen;followtheonscreeninstructionstofinishthecalibrationprocess

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8. Gasflowshouldbesetto1.0litresperminute

9. Asuccessfulcalibrationwillbeindicatedbythe ,press toreturntothehomescreen

10. Afailedcalibrationwillbeindicatedby ,press toattemptcalibrationagain–iftheproblempersistssee‘troubleshooting’orcallyourlocalsupplierofBedfont®products

11. Returntothehomescreenbypressing

COdata+™software–connectingtothePCPlaceoneendoftheconnectionleadintotheUSBsocketonthetopoftheSmokerlyzer®product,connectingtheotherendtotheUSBportonthePC.Beforestartingthesoftware,ensurethattheSmokerlyzer®productisconnectedtothePCandswitchedon.DoubleclicktheCOdata+™icononthePCtostarttheprogramme.RefertothesupplieddocumentationforhowtooperateCOdata+™.

ReturnsprocedureIfyourequipmentrequiresservicing,pleasecontactyourlocalBedfont®customerservicedepartment,distributororsupplierbeforereturninganygoods.

1. Whenyouhavesuppliedthecustomerrepairsdepartmentwiththemonitorserialnumberanddescriptionofthefault,youwillbeissuedwithareturns/ticketnumber.Pleasestatethereturns/ticketnumberontheoutsideoftheboxwhenreturningthemonitor,andensurethatyourfulldetails,telephone,faxnumbersandreturnaddressareclearlystated.

2. Theproductmustalsobedecontaminatedbeforeitisreturnedaccordingtoyourlocalregulations.Bedfont®canprovideyouwithadecontaminationcertificatetocomplete,whichalsoneedstobeattachedtotheoutsideofthebox.FailuretodosowillresultintheproductbeingsubjecttoBedfont®decontaminationprocedureandwilldelayyourservice/repair.

3. Bedfont®advisethatyouuseacourierservicewhenreturningmonitors.Thisenablesyoutoinsuregoodsforlossordamageintransit.Whenyourgoodsarereceived,youwillbesentanemailstatingso.

4. Ifthedevicehasbeenreturnedforrepairitwillthenbeexaminedandyouwillbesentan‘engineer’sreport’andaquotationfortherepair,whichwillincludeanauthorisationform.Completetheauthorisationform,andensurethatyouincludethe‘officialpurchaseordernumber’.Pleasecontactthecustomerrepairsdepartmentifyouareunabletosupplyan‘officialpurchaseordernumber’.

5. Ifyourmonitorisstillinwarrantyandthefaultiscoveredbywarranty,see‘warranty’sectionofthismanual,Bedfont®willrepairitandreturnittoyouwithan‘engineer’sreport’,freeofcharge.

6. Ifyouchoosenottoproceedwiththerepair,ahandlingfeewillbecharged.Ensurethatyoureturnthecompletedauthorisationformwithan‘officialpurchaseordernumber’.

7. TheequipmentwillbereturnedtoyouassoonasBedfont®hasreceivedallrelevantpaperwork.Acarriagefeewillbechargedifthemonitorisnolongerinwarranty.

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SparesSteriBreath™mouthpieces: SteriBreath™mouthpiecesarebothcosteffectiveand

compact.Theyareindividuallysealedforoptimuminfectioncontrol,whilstcondensationinthetubeconfirmsanaccuratebreathsample.

D-piece™: TheD-piece™isusedtoattachaSteriBreath™mouthpiecetothemonitor.TheD-piece™incorporatesaone-wayvalveandaninfectioncontrolfilter,whichareproventoremoveandtrap>99.9%ofairbornebacteria5.TheD-piece™shouldbechangedeveryfourweeksormoreoftenifvisiblysoiled.Anautomaticreminderwillappearonthescreenevery28days.

OneBreath™mouthpieces: TheOneBreath™mouthpieceisasingle-usebacterialfiltermouthpieceandcanbeattacheddirectlytothemonitortotakeabreathsample.TheOneBreath™incorporatesaone-wayvalveandaninfectioncontrolfilter,whichareproventoremoveandtrap>99.9%ofairbornebacteria5.

Monitorcleaningwipes: Freefromalcoholtoensurecontinuedperformanceofyourmonitor.ProductscontainingalcoholcannotbeusedonanyoftheSmokerlyzer®range.

WarrantyBedfont®ScientificLimitedwarrantsthepiCO™,piCObaby™andMicro+™Smokerlyzer®products(excludingbatteries)tobefreeofdefectsinmaterialsandworkmanshipforaperiodoffiveyearsfromthedateofshipment.Bedfont’ssoleobligationunderthiswarrantyislimitedtorepairingorreplacing,atitschoice,anyitemcoveredunderthiswarrantywhensuchanitemisreturned,intactandprepaid,toBedfont®orthelocalrepresentative.

Thesewarrantiesareautomaticallyinvalidatediftheproductsarerepaired;altered,voidlabelsremovedorotherwisetamperedwithbyunauthorisedpersonnel,orhavebeensubjecttomisuse,neglectoraccident.

Neverdisposeofanyelectronicinstrumentorbatteriesindomesticwaste.Attheendoftheproduct’slife,contactBedfont®oritsdistributorfordisposalinstructions.

References1. CarbonMonoxidePoisoning—NEJM[Internet].NewEnglandJournalofMedicine.2017

[cited14March2017].Availablefrom:http://www.nejm.org/doi/full/10.1056/NEJM199811263392206

2. AndrewH.CarbonMonoxide‘TheSilentKiller’FeasibilityStudy2009/2010.1sted.London:LondonAmbulance;2017

3. CraigSmollinK.Carbonmonoxidepoisoning(acute)[Internet].PubMedCentral(PMC).2017[cited14March2017].Availablefrom:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217756/

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4. StewartRDe.Rapidestimationofcarboxyhemoglobinlevelinfirefighters.-PubMed-NCBI[Internet].Ncbi.nlm.nih.gov.2017[cited17March2017].Availablefrom:https://www.ncbi.nlm.nih.gov/pubmed/946082

5. HealthProtectionAgency(HPA).PortonDown,ReportNo.43/06.Pp.10-11

Bedfont® Scientific Ltd. Station Road, Harrietsham, Maidstone, Kent, ME17 1JA EnglandTel: +44 (0)1622 851122 Fax: +44 (0)1622 854860 Email: [email protected]

Issue 4- December 2018 Part No: LAB679 Bedfont® Scientific Limited reserves the right to change or update this literature without prior notice.Registered in: England and Wales. Registered No: 1289798

© Bedfont® Scientific Limited 2018

Contact Bedfont® or one of our worldwide Smokerlyzer® distributors for a free demonstration.

www.bedfont.comTel:+44 (0)1622 851122

Email: [email protected]

A full list of our worldwide distributors can be found at http://www.bedfont.com/uk/english/distributors

Our family, innovating health, for yours.

est. 1976

lab679 smokerlyzer manual - issue 4 - bedfont · the cut-off point between smoker and non-smoker...

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