Baxter (Flo-Gard 6201) Volumetric Infusion Pump Flow Rate Accuracy - Test Design and Performance Verification

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BAXTER(FLO-GARD6201)

VOLUMETRICINFUSIONPUMP

FLOWRATEACCURACY:TESTDESIGN

ANDPERFORMANCEVERIFICATION

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SoheilHajiMohammadi SoheilHajiMohammadi HaniehKamelian HaniehKamelian KoushaTalebian KoushaTalebian

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Abstract

Intheclinicalsettings,continuousmonitoringthefluidline(e.g.saline,medications, Intheclinicalsettings,continuousmonitoringthefluidline(e.g.saline,medications, antisepticdrugs)iscriticalforqualitycontrolandsafetypurposes.Thus,thereisa antisepticdrugs)iscriticalforqualitycontrolandsafetypurposes.Thus,thereisa se

seririououss neeneedd foforr aa rereliliabablele ininfufusisionon pupumpmp ththatat isis sesensnsititivive,e, elelecectrtricicalallyly sasafefe anandd patientsafe.Oneofthemostimportantfactorsimpactingapumpperformanceisits patientsafe.Oneofthemostimportantfactorsimpactingapumpperformanceisits flowrate.Subsequently,therearevariousmethodstoverifythedegreetowhichthe flowrate.Subsequently,therearevariousmethodstoverifythedegreetowhichthe flowrate

flowrateisaccurate.Attimes,depenisaccurate.Attimes,dependingontheapplicatdingontheapplicationoftheinfusionionoftheinfusiontherapytherapy (inanesthesiaorforthepurposeofmedicationadministration),accuracyoftheflow (inanesthesiaorforthepurposeofmedicationadministration),accuracyoftheflow ratecancriticallyendangerboththesafetyoftheuserandthepatient.Thisreport ratecancriticallyendangerboththesafetyoftheuserandthepatient.Thisreport pr

presesenentsts fifiveve memeththododss toto exexamamininee ththee acaccucuraracycy ofof ththeeBaxBaxteterr (Fl(Flo-Go-Gardard 6206201)1) infusionpump

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TableofContent

Abstract...2 Abstract...2 1.Scope...4 1.Scope...4 2.Objective...4 2.Objective...4 3.Introduction...5 3.Introduction...5 3.1.BaxterInfusionPump...5 3.1.BaxterInfusionPump...5 3.2.FlowRateCalculation...5 3.2.FlowRateCalculation...5 3.3.ClinicalConsiderationWhileSettingtheFlowRate...6 3.3.ClinicalConsiderationWhileSettingtheFlowRate...6 3.4.FlowRateAccuracy...6 3.4.FlowRateAccuracy...6 3.5.FunctionalBlockDiagram...7 3.5.FunctionalBlockDiagram...7 4.MethodstoTesttheFlowRateAccuracy...8 4.MethodstoTesttheFlowRateAccuracy...8 4.1.TestParameters...8 4.1.TestParameters...8 4.2.CriteriatobeConsideredDuringTesting...8 4.2.CriteriatobeConsideredDuringTesting...8 4.3.InstrumentsNeeded 4.3.InstrumentsNeeded...8...8 4.4.TestSetup...8 4.4.TestSetup...8 4.5.TestProcedures...10 4.5.TestProcedures...10 4.5.1.Method1-MeasurementbyWeightperTime...10 4.5.1.Method1-MeasurementbyWeightperTime...10 4.5.2.Method2-MeasurementbyVolumeperTime...10 4.5.2.Method2-MeasurementbyVolumeperTime...10 4.5.3.Method3-MeasurementbyTimeperVolume...11 4.5.3.Method3-MeasurementbyTimeperVolume...11 4.5.4.Method4-MeasurementIncorporatingVTBIOption...11 4.5.4.Method4-MeasurementIncorporatingVTBIOption...11 4.5.5.Method5-One-HourAccuracyTest...11 4.5.5.Method5-One-HourAccuracyTest...11 5.Results...12 5.Results...12 6.Discussion...14 6.Discussion...14 7.FactorsAffectingTestResults&Accuracy 7.FactorsAffectingTestResults&Accuracy...15...15 8.Conclusion...16 8.Conclusion...16 9.Recommendation/FutureWork...16 9.Recommendation/FutureWork...16 10.Bibliography...17 10.Bibliography...17 AppendixA:Method1Data AppendixA:Method1Data...18...18 AppendixB:Method2...19 AppendixB:Method2...19 AppendixC:Method3&Method4...20 AppendixC:Method3&Method4...20 AppendixD:Method5...21 AppendixD:Method5...21

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1.Scope

Thisreportintroducesfivemethodstomeasureandexaminetheaccuracyofthe Thisreportintroducesfivemethodstomeasureandexaminetheaccuracyofthe Ba

Baxtxterer SiSingnglele ChChanannenell (F(Flolo-G-Garardd 62620101)) InInfufusisionon PuPumpmp flflowow raratete.. ThThee rerepoportrt isis parti

partitionedtionedtotothefollowithefollowingsections:ngsections:ObjectiveObjective,Introducti,Introduction(i.e.TypesofInfusion,on(i.e.TypesofInfusion, BaxterInfusionPump,FlowRateCalculation,ClinicalConsiderationWhileSetting BaxterInfusionPump,FlowRateCalculation,ClinicalConsiderationWhileSetting theFlowRate,FlowRateAccuracyandFunctionalBlockDiagram),Methods,Results, theFlowRate,FlowRateAccuracyandFunctionalBlockDiagram),Methods,Results, Discussion,FactorsAffectingtheAccuracyoftheFlowRateand,Conclusion. Discussion,FactorsAffectingtheAccuracyoftheFlowRateand,Conclusion.

2.Objective

As

As menmentiotionedned preprevioviousluslyy inin thethe AbsAbstratract,ct, inacinaccurcuracyacy andand malmalfunfunctictionon ofof infinfusiusionon pu

pumpmpss cacann reresusultlt inin serserioiousus anandd crcrititicicalal cocompmplilicacatitionsons andand haharmrm toto ththee papatitientent.. Accordingly,ouraimfromthisprojectwastodesigntestmethodstomeasureand Accordingly,ouraimfromthisprojectwastodesigntestmethodstomeasureand verifytheBaxterinfusionpumpflowrateaccuracy.

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3.Introduction

Infusionpumpsareelectronicdevicesusedtocontroladministrationofintravenous Infusionpumpsareelectronicdevicesusedtocontroladministrationofintravenous fluidsinverysmallamountsandatacarefullyregulatedrateoverselectedperiodof fluidsinverysmallamountsandatacarefullyregulatedrateoverselectedperiodof time.

time.TheyareclassifiTheyareclassifiedbasedontheirvolumedbasedontheirvolumecapacity(i.eecapacity(i.e.smallorlarge),.smallorlarge),typeoftypeof pump(i.e.volu

pump(i.e.volumetrimetricorsyringe)andflowratemechaniscorsyringe)andflowratemechanisms(i.e.througms(i.e.throughgravityhgravityoror ro

rollllerer pupumpmp).). AcAccocordrdiningg toto FDFDA,A, anan ininfufusisionon pupumpmp isis aa ClClassass IIII dedevivicece.. HoHowewevever,r, Hea

Healthlth CanCanadahasclassadahasclassifiifieditedit asaasa ClaClassIIIdevicssIIIdevicebyeby (Ru(Rule11le11 andand SubSub RulRulee(1)(1)),), wher

whereiteitisdescribisdescribedasedasanactive,therapanactive,therapeuticeuticandandsurgisurgicallyinvascallyinvasivedevice(Chan,ivedevice(Chan, 2013).

2013).

3.1.BaxterInfusionPump 3.1.BaxterInfusionPump

Th

Thee BaxBaxteterr (F(Flolo-G-Garardd 62620101)) ininfufusisionon pupumpmp isis anan elelecectrtromomecechahaninicacall tytypepe pupumpmp.. Similartoanyotherinfusiontype,itisusedfortheintravenousinfusionofliquids Similartoanyotherinfusiontype,itisusedfortheintravenousinfusionofliquids suc

suchh asasmedmedicaicatiotions,ns,nutnutrierientsnts andandantantiseiseptipticc admadminiinistrstratiations;ons; thethe useuserr cancan selselectect tthehe rratate.e. ThThee pupumpmp isis cocompmpososeded ofof aa lilinenearar peperrisistataltltiicc pupummpp heheadad,, wwhihichch iiss programmable(MadWrench,LCC,2011)(SystemsIntegratedMedical,2011).

programmable(MadWrench,LCC,2011)(SystemsIntegratedMedical,2011). The

The pumpumpp useusess VolVolumeume-Ti-TimemeProProgragrammimming.ng. ThiThiss tectechnohnologlogyy allallowsows usustotoselselectect aa volume-to-be-infused(VTBI)andtheamountoftimeoverwhichtheinfusionisto volume-to-be-infused(VTBI)andtheamountoftimeoverwhichtheinfusionisto takeplace.Then,thepumpautomaticallycalculatestheflowraterequiredtodeliver takeplace.Then,thepumpautomaticallycalculatestheflowraterequiredtodeliver thedesiredVTBIinthatspecifictimeperiod.Ifthecalculatedflowrateishigher thedesiredVTBIinthatspecifictimeperiod.Ifthecalculatedflowrateishigher thanthepump’scapabilities,thepumpwilldisplaythemessage“

thanthepump’scapabilities,thepumpwilldisplaythemessage“HiHi”;similarly,ifthe”;similarly,ifthe calcul

calculatedflowatedflowrateislowerthanthepump’rateislowerthanthepump’scapabilscapabilitiesities,thepumpwilldispl,thepumpwilldisplaytheaythe mes

messagsagee ““LoLo”” ThThereree araree cucurrrrententlyly 55 appapplilicabcablele memeththododss toto tetestst foforr ththee flflowow raratete

accuracyoftheBaxterinfusionpump(MadWrench,LCC,2011)(SystemsIntegrated accuracyoftheBaxterinfusionpump(MadWrench,LCC,2011)(SystemsIntegrated Medical,2011). Medical,2011). 3.2.FlowRateCalculation 3.2.FlowRateCalculation Fl

Fluiuidd flflowow raratete (F(FR)R) ococcucursrs asas aa reresusultlt ofof ththee rerelalatitiononshshipip ofof prpresessusurere (P(P)) anandd resistance(R). resistance(R).   ==     Fl

Flowow raratete imimpapactctss reresisiststanancece anandd reresisiststanancece imimpapactctss ththee amamouountnt ofof prpresessusurere requiredtoachievetheflowrate(Mocklin,2011).

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3.3.ClinicalConsiderationWhileSettingtheFlowRate 3.3.ClinicalConsiderationWhileSettingtheFlowRate Thefollowingprinciplesapplytoflowrates(Mocklin,2011): Thefollowingprinciplesapplytoflowrates(Mocklin,2011): • • High-resistancesystemsrequirethemostamountofpressure(e.g.,infusingHigh-resistancesystemsrequirethemostamountofpressure(e.g.,infusing intoahypertensivepatientwithleftventricularhypertrophyorpulmonary intoahypertensivepatientwithleftventricularhypertrophyorpulmonary hypertension). hypertension). •• HighflowratesinlowresistancesystemswillrequirelesspressurethaninHighflowratesinlowresistancesystemswillrequirelesspressurethanin highresistancesystems(e.g.,infusingfluidrapidlyintoahypotensivepatient highresistancesystems(e.g.,infusingfluidrapidlyintoahypotensivepatient inshock). inshock).

•• LoLoww flflowow raratetess inin hihighgh reresisiststanancece sysyststememss wiwillll rereququiriree lelessss prpresessusurere ththanan hi

highgh flflowow raratetess (e(e.g.g.,., ininfufusisingng atat ththee KeKeepep VeVeinin OpOpenen [K[KVOVO]] raratete inintoto ththee hypertensivepatient).

hypertensivepatient).

•• LowLow flofloww ratrateses inin lowlow resresististancancee syssystemtemss wilwilll reqrequiruiree thethe leasleastt amoamountunt ofof pressure.Forexample,KVOrateintoahypotensivepatient.

pressure.Forexample,KVOrateintoahypotensivepatient.

3.4.FlowRateAccuracy 3.4.FlowRateAccuracy

Mos

Mostt infinfusiusionon pumpumpp manmanufaufactucturerrerss stastatete thethe accaccurauracycy ofof thethe deldeliveiveredred dosdosee asas aa per

percentcentageage.. AA useuserr manumanualal maymay reareadd ‘ac‘accurcuracyacy:: ±5%±5%’.’. IdeIdeallally,y, thithiss shoshoulduld bebe thethe flowrate

flowrateaccuracyaccuracy,meaningthatove,meaningthatoverthecompleterthecompleteperiodofinfusiperiodofinfusion,theflowrateon,theflowrate (inmL/hour)willnotvarybeyondtheselimits.Suchpumpsshouldhaveasmooth (inmL/hour)willnotvarybeyondtheselimits.Suchpumpsshouldhaveasmooth andsteadydelivery.Sometimes,however,thequotedaccuracymayrefertothetotal andsteadydelivery.Sometimes,however,thequotedaccuracymayrefertothetotal volum

volumedeliveredeliveredbytheendoftheinfuedbytheendoftheinfusionperisionperiod.Insuchcasesod.Insuchcases,thefinaldose,thefinaldosewillwill bewithi

bewithinthespecifienthespecifiedlimits,butdlimits,butnonoindicindicationisgivenationisgivenonhowconstantorsmoothonhowconstantorsmooth theflowhasbeenduringinfusion.

theflowhasbeenduringinfusion. For

For syrsyringingee pumpumps,ps, whiwhichch makmakee useuse ofof sinsinglegle-us-usee syrsyringinges,es, manymany manmanufaufactucturerrerss definetheaccuracyofthelineardisplacementoftheplunger.Thisisthemechanical definetheaccuracyofthelineardisplacementoftheplunger.Thisisthemechanical ac

accucurracacyy ofof ththee pupummpp ititseselflf anandd exexclclududeses ththee adaddidititiononalal ererrroror cacaususeded bbyy ththee in

incoconsinsiststencencyy ofof sisingnglele-u-usese sysyriringnges.es. ThThee ususerer shshououldld bebe awawararee ththatat sisingnglele ususee syringesmightcauseflowdeviationsupto4%greaterthanthosespecifiedforthe syringesmightcauseflowdeviationsupto4%greaterthanthosespecifiedforthe lineardisplacement.

lineardisplacement. As

As thethe maimaintenntenanceance ofof conconstastantnt blobloodod levlevelsels maymay bebe cricriticticalal forfor somsomee drudrugs,gs, itit isis imp

importortantant toto seasearchrch thethe useuserr manmanualual oror anyany accoaccompampanyinyingng litliteraeraturturee forfor furfurthetherr referencestoaccuracy(Ferrari&Beech,1995).

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Cancel Anytime. 3.5.FunctionalBlockDiagram 3.5.FunctionalBlockDiagram Figure1showsthefunctionalblockdiagramforagenericvolumetricinfusionpump. Figure1showsthefunctionalblockdiagramforagenericvolumetricinfusionpump. Onthelefthandside,theuserinput

Onthelefthandside,theuserinput (e.(e.g.VTBI)g.VTBI)/ou/outputputtintinterferfaceace isshownisshown..OntheOnthe righthandside,theinternalblockdiagramsofthepumpareshown.

righthandside,theinternalblockdiagramsofthepumpareshown.

Figure1:

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4.Methodsto

4.MethodstoTesttheFlowRat

TesttheFlowRateAccuracy

eAccuracy

4.1.TestParameters 4.1.TestParameters ● ● Weight(g)Weight(g) ● ● VolumetobeInfused(VTBI)(mL)VolumetobeInfused(VTBI)(mL) ● ● Time(s)Time(s) 4.2.CriteriatobeConsideredDuringTesting 4.2.CriteriatobeConsideredDuringTesting Thefollowingassumptionsandfactorswereconsideredduringthetesting: Thefollowingassumptionsandfactorswereconsideredduringthetesting: ● ● Theinfusionsetiscorrectlyprimedandused.Theinfusionsetiscorrectlyprimedandused. ● ● Therearenostructuralandfunctionaldefectsintheinfusionpump.Therearenostructuralandfunctionaldefectsintheinfusionpump. ● ● Theinfusionlineisgoodfortherepetitionoftests.Theinfusionlineisgoodfortherepetitionoftests. ● ● Thereisnomovementinthelineasthewaterispassedthrough.Thereisnomovementinthelineasthewaterispassedthrough. ● ● Theheightatwhichthelineissetatisthesameastheonesetforpatient’sTheheightatwhichthelineissetatisthesameastheonesetforpatient’s infusiontherapy. infusiontherapy. 4.3.InstrumentsNeeded 4.3.InstrumentsNeeded ● ● Baxter(Flo-Gard6201)volumetricinfusionpumpBaxter(Flo-Gard6201)volumetricinfusionpump ● ● AcrystalbowlAcrystalbowl ● ● Acalibratedscalewitharesolutionofatleast0.1gramsAcalibratedscalewitharesolutionofatleast0.1grams ● ● ASTMClassA25mLgraduatedcylinderwitharesolutionofatleast0.2mLASTMClassA25mLgraduatedcylinderwitharesolutionofatleast0.2mL ● ● BaxterContinu-FlosolutionsetBaxterContinu-Flosolutionset ● ● Solutionfluid(i.e.distilledwater)Solutionfluid(i.e.distilledwater) 4.4.TestSetup 4.4.TestSetup Thefollowingfourstepsarerequiredforthepreparationofthetest(MadWrench, Thefollowingfourstepsarerequiredforthepreparationofthetest(MadWrench,

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Cancel Anytime. Note:Thetubingmustbecleananddrybeforeitisinsertedintothepump.Makesure Note:Thetubingmustbecleananddrybeforeitisinsertedintothepump.Makesure thatthetubingisplacedandseatedproperlyintheguidechannel,pumpmechanism, thatthetubingisplacedandseatedproperlyintheguidechannel,pumpmechanism, sensors,andsafetyclamp.Ensurethatthereisnoslackinthetubingandthatitisnot sensors,andsafetyclamp.Ensurethatthereisnoslackinthetubingandthatitisnot kinkedorpinc

kinkedorpinchedbeforeclosinhedbeforeclosingthepumpdgthepumpdoor.oor.

3.

3. LLoaoadd ththee sesett inintoto tthehe pupummp.p. ClClososee ththee pupumpmp dodooor.r. TTheherree shshououldld bbee nono excessiveresistance.Neverusetoolsorexcessiveforcetocloseapumpdoor. excessiveresistance.Neverusetoolsorexcessiveforcetocloseapumpdoor. 4.Placethedis

4.Placethedistalendoftheadmitalendoftheadministrnistrationsetinacontaationsetinacontainerorsininerorsinktodisposektodispose ofpumpedsolution.

ofpumpedsolution. 



Note:DoNOT

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Cancel Anytime. 4.5.TestProcedures 4.5.TestProcedures Belowrepresentsfourshorttimeaccuracytests,aswellasaone-hourlongaccuracy Belowrepresentsfourshorttimeaccuracytests,aswellasaone-hourlongaccuracy testfortheBaxt

testfortheBaxterinfusierinfusionpump.Thefouronpump.Thefourshorttestscompushorttestscomputetheinfusiotetheinfusionratebynrateby measuringweightpertime,volumepertime,timepervolume,andVTBI(Volumeto measuringweightpertime,volumepertime,timepervolume,andVTBI(Volumeto BeInfused).Attheendofthisdocument,fivedata-collectionchartsareincludedto BeInfused).Attheendofthisdocument,fivedata-collectionchartsareincludedto referringtothefivetests.Allmethodsareusedtocalculatetheinfusionrate,but referringtothefivetests.Allmethodsareusedtocalculatetheinfusionrate,but onlyM1,M2andM5areusedtomeasuretheaccuracyoftheinfusionrate.Andfor onlyM1,M2andM5areusedtomeasuretheaccuracyoftheinfusionrate.Andfor validatingtheaccuracyofeachofthreemethodsbetter,therearetwoapproachesto validatingtheaccuracyofeachofthreemethodsbetter,therearetwoapproachesto M1

M1,, M2M2 anandd M5M5:: ononee isis memeasasururiningg ththee ininfufusisionon raratete byby plplotottitingng ththee reresusultlt anandd calcul

calculatingatingtheslopeandtheotheroneisdivtheslopeandtheotheroneisdividingidingthefinalvolumthefinalvolumebythetotaltimeebythetotaltime togettheaverageinfusionrate.Thefollowingfivemethodshavebeentakenfrom togettheaverageinfusionrate.Thefollowingfivemethodshavebeentakenfrom theoperationmanual(MadWrench,LCC,2011)(SystemsIntegratedMedical,2011). theoperationmanual(MadWrench,LCC,2011)(SystemsIntegratedMedical,2011). As

As susuchch,, ththee cocontntenentt hahass bebeenen momodidififieded,, bubutt mamayy ststililll cocontntaiainn phphrarasesess frfromom ththee originalscript.

originalscript.

4.5.1.Metho

4.5.1.Method1-Measurementd1-MeasurementbyWeightperbyWeightperTimeTime 1.

1. ProgramaPRIVTBIofatleast500mLandstartthepumpat200mL/hr.ProgramaPRIVTBIofatleast500mLandstartthepumpat200mL/hr.

2.

2. PlPlacacee aa cocontntaiainenerr onon aa cacalilibrbratateded scscalalee wiwithth aa reresosolulutitionon ofof 0.0.11 grgramamss oror betterandzerothescale.

betterandzerothescale.

3.

3. MeMeasasururee ththee weweigightht ofof ththee cocontntaiainenerr evevereryy 3030 sesecocondndss ±± 33 sesecocondndss foforr durationof10minutesand30seconds.

durationof10minutesand30seconds.

4.

4. DiviDividethedetheweighweightbytbyspecifspecificgravityicgravity ofthesolution(water’ofthesolution(water’sspecificgravitsspecificgravityy is0.998g/mLatroomtemperature)andplottheresults.Theslopeoftheline is0.998g/mLatroomtemperature)andplottheresults.Theslopeoftheline istheinfusionrate. istheinfusionrate. 5. 5. DividethefinalweightfromthetotaltimeandbythespecificgravitytogetDividethefinalweightfromthetotaltimeandbythespecificgravitytoget theaverageinfusionrate. theaverageinfusionrate. 6.

6. TheThe tottotalal solsolutiutionon colcolleclectedted atat thethe 10-10-minminuteute deadeadlidlinene shoshoulduld bebe betbetweeweenn 32.5mLto37.5mL.

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4.5.3.Metho

4.5.3.Method3-Measurementd3-MeasurementbyTimeperVobyTimeperVolumelume 1.

1. ProgramaPRIRATEof200mL/hrandaPRIVTBIgreaterthan35mL.ProgramaPRIRATEof200mL/hrandaPRIVTBIgreaterthan35mL.

2.

2. CoCollllecectt ththee sosolulutitionon inin anan ASASTMTM ClClasasss AA 2525mLmL grgraduaduateatedd cycylilindnderer,, wiwithth aa resolutionof0.2mLorbetter.

resolutionof0.2mLorbetter.

3.

3. Measurethetimewithin3secondsthatittakestocollect25mL±0.2mL.Measurethetimewithin3secondsthatittakestocollect25mL±0.2mL.

4.

4. CaCalclcululatatee ththee flflowow raratete inin mLmL/h/hrr byby didivivididingng 3535mLmL byby ththee memeasasurureded titimeme convertedtohours.

convertedtohours.

5.

5. Theflowrateshouldbebetween186.0mL/hrand214.0mL/hr.Theflowrateshouldbebetween186.0mL/hrand214.0mL/hr.

4.5.4.Metho

4.5.4.Method4-Measurementd4-MeasurementIncorporatinIncorporatingVTBIOptiongVTBIOption 1. 1. ProgramaPRIRATEof200mL/hrandaPRIVTBIof35mL.ProgramaPRIRATEof200mL/hrandaPRIVTBIof35mL. 2. 2. Startthepumpandcollectthesolutioninacontainerofknownweight.WhenStartthepumpandcollectthesolutioninacontainerofknownweight.When thepumpgoesintoKVOalertmode,stopthepumpwithin20seconds. thepumpgoesintoKVOalertmode,stopthepumpwithin20seconds. 3.

3. UseUse acalibracalibrateateddscascalewithlewith aresoluaresolutiotionnof0.1gramsof0.1grams orbetteorbettertorto weiweightheghthe co

contntaiainenerr anandd sosolulutitionon.. ThThenen didivividede ththee sosolulutitionon weweigightht byby ththee spspececifificic gr

gravavitityy ofof ththee sosolulutitionon (w(wataterer’s’s spspececifificic grgravavitityy isis 0.0.999988 g/g/mLmL atat roroomom temperature).

temperature).

4.

4. Thesolutioncollectedshouldbebetween32.5mLand37.5mL.Thesolutioncollectedshouldbebetween32.5mLand37.5mL.

4.5.5.Metho

4.5.5.Method5-One-Hourd5-One-HourAccuracyTestAccuracyTest 1.

1. ProgramaPRIRATEof125mL/hrwithaPRIVTBIof1000mL.ProgramaPRIRATEof125mL/hrwithaPRIVTBIof1000mL.

2.

2. PlPlacacee aa cocontntaiainenerr onon aa cacalilibrbratateded scscalalee wiwithth aa reresosolulutitionon ofof 0.0.11 grgramamss oror betterandzerothescale.

betterandzerothescale.

3.

3. PlPlacacee ththee didiststalal enendd ofof ththee ininfufusisionon sesett inintoto aa cocontntaiainener,r, anandd plplacacee ththee co

contntaiainenerr onon aa cacalilibrbratateded scscalalee wiwithth aa reresosolulutitionon ofof 0.10.1 grgramamss oror bebetttterer.. Recordtheweightofthecontainer.

Recordtheweightofthecontainer.

4.

4. Simultaneously,startatimerandpresstheSTARTkey.Simultaneously,startatimerandpresstheSTARTkey.

5.

5. MeMeasasururee ththee weweigightht ofof tthehe cocontntaiainenerr evevereryy 33 miminunutetess ±± 33 sesecocondndss foforr durationof1hour.

durationof1hour.

6.

6. DiviDividethedetheweighweightbytbyspecifspecificgravityicgravity ofthesolution(water’softhesolution(water’sspecificgravityspecificgravity is0.998g/mLatroomtemperature)andplottheresults.Theslopeoftheline is0.998g/mLatroomtemperature)andplottheresults.Theslopeoftheline

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5.Results

Table1summarizestheresultsofthefivemeasurementmethodsperformed.The Table1summarizestheresultsofthefivemeasurementmethodsperformed.The raw

raw datdataaisincluisincludedded intheappendintheappendixforreferixforreferenceence (Ap(AppendpendixA:ixA:MetMethodhod 1Datato1Datato AppendixD:Method5).RateisinmL/hr.Averagemeasuredrateiscalculatedby AppendixD:Method5).RateisinmL/hr.Averagemeasuredrateiscalculatedby dividingthefinalvolumevaluebythetotaltime,wheretheslope(themeasured dividingthefinalvolumevaluebythetotaltime,wheretheslope(themeasured ra

ratete)) isis cacalclcululatateded byby fifittttiningg aa lilinenearar lilinene toto ththee memeasasurureded dadatata.. FrFromom heherere onon,, me

meththododss araree rerefeferrrreded toto asas M1M1 ththrorougughh M5M5 foforr easeasee ofof rerefefererencence.. SiSimimilalarlrly,y, ththee averagepercenterrorisreferredtoasAPE,andtheslopepercenterrorisreferred averagepercenterrorisreferredtoasAPE,andtheslopepercenterrorisreferred toasSPE.

toasSPE.

Table1:

Table1:ResultsobtainedfromtResultsobtainedfromthefiveaccurhefiveaccuracytests.acytests. M1: M1: Weightper Weightper Time Time Method Method M2: M2: Volume Volume perTime perTime Method Method M3: M3: Timeper Timeper Volume Volume Method Method M4: M4: VTBI VTBI Method Method M5: M5: One-Hour One-Hour Accuracy Accuracy Test Test TargetRate TargetRate (mL/hr) (mL/hr) 2 20000..00 220000..00 220000..00 220000..00 112255..00

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Figure3:

Figure3:Weightpertimetestmethod.Weightpertimetestmethod.

y=3.4486x-0.3963 y=3.4486x-0.3963 R²=0.99998 R²=0.99998 0 0 10 10 20 20 30 30 40 40 0 0 55 1100 1155 V V o o l l u u m m e e ( ( m m L L ) ) Time(min) Time(min)

WeightperTime

Series1 Series1 Linear(Series1) Linear(Series1) y=3.4951x-0.1424 y=3.4951x-0.1424 R²=0.99995 R²=0.99995 10 10 15 15 20 20 25 25 m m e e ( ( m m L L ) )

VolumeperTime

Series1 Series1

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6.Discussion

Ac

Accocordrdiningg toto ththee cocollllecectetedd dadatata,, alalll memeththododss wewerere wiwiththinin ththee acacceceptptabablele rarangngee suggestedbythemanufacturer(thisreferstothelastbulletpointofeachmethod). suggestedbythemanufacturer(thisreferstothelastbulletpointofeachmethod). ComparingM1,M2andM5,M5percenterror(%2.2±.2)showsthatitisthemost ComparingM1,M2andM5,M5percenterror(%2.2±.2)showsthatitisthemost ac

accucuraratete memeththodod.. ThThisis alalsoso shshowowss ththatat ththee lolongngerer ththee ininfufusisionon titimeme,, ththee momorere accuratetheresultswouldbe.Inaddition,chi-squaredvalueforallthreecalculated accuratetheresultswouldbe.Inaddition,chi-squaredvalueforallthreecalculated to

to bebe .9.999999;9; ththisis shshowowss ththatat ththee dadatata foforr alalll isis ofof gogoodod ququalialityty andand ththatat alalll ththrereee methodsareaccurate.

methodsareaccurate.

Table2:

Table2:ErrorpercentagesofMetErrorpercentagesofMethod1,2anhod1,2and5.d5. M1: M1: Weightper Weightper TimeMethod TimeMethod M2: M2: Volumeper Volumeper TimeMethod TimeMethod M5: M5: One-Hour One-Hour AccuracyTest AccuracyTest %Error %Error Average(APE) Average(APE) 33..4455 44..8855 22..3399 Slope(SPE) Slope(SPE) 22..5544 44..0000 22..2200 %ErrorAvgof %ErrorAvgof APE&SPE APE&SPE 3 3..0000 ±± 00..4455 44..4433 ±± ..4433 22..22 ±± ..22

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7.FactorsAf

7.FactorsAffectingTestRes

fectingTestResults&Accurac

ults&Accuracy

y

In

In gegeneneraral,l, ththee fofollllowowiningg fafactctororss cacann ininflflueuencncee ththee flflowow raratete memeasasururememenentt anandd performanceofaninfusionpump: performanceofaninfusionpump: ● ● AirtrappedintheContinu-FlosolutionsetAirtrappedintheContinu-Flosolutionset ● ● Non-sterilefluidpathNon-sterilefluidpath ● ● Solutionsetstoredintemperatureslessthan15Cormorethan30CSolutionsetstoredintemperatureslessthan15Cormorethan30C ● ● LeakageorocclusionintheIVtubeLeakageorocclusionintheIVtube ● ● DisruptormalfunctionedelectricalconnectionsDisruptormalfunctionedelectricalconnections Fr

Fromom ththee mamanunufafactctururiningg rerecocommmmenendadatitionon,, ththee reresosolulutitionon ofof ththee scscalalee anandd ththee graduatedcylinderneedtobe0.1gand0.2mLrespectively.Thescaleusedforthis graduatedcylinderneedtobe0.1gand0.2mLrespectively.Thescaleusedforthis sseettuupp hhaadd aa rreessoolluuttiioonn ooff 00..0011gg,, wwhhiicchh hhaass aa hhiigghheerr rreessoolluuttiioonn tthhaann tthhee manufacture’srecommendation.Thegraduatedcylinder,however,hadaresolution manufacture’srecommendation.Thegraduatedcylinder,however,hadaresolution of

of 0.20.2mL,mL, whiwhichch waswas thethe samsamee asas thethe manmanufaufactucture’re’ss recrecommommendendatiation.on. TheTherefreforeore,, method1,andmethod5arebettertestprocedures.

method1,andmethod5arebettertestprocedures. Th

Thee sasameme ininfufusisionon lilinene wawass ususeded foforr alalll fifiveve teteststs.s. ThThee pupumpmp ususeded aa clclamampp foforr se

secucuriringng ththee ininfufusisionon liline,ne, asas wewellll asas ststopoppipingng ththee ininfufusisionon.. AsAs aa reresusultlt,, ththee lilinene sh

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8.Conclusion

Ac

Accocordrdiningg toto ththee cocollllecectetedd dadatata,, alalll memeththododss wewerere wiwiththinin ththee acacceceptptabablele rarangngee suggestedbythemanufacturer(thisreferstothelastbulletpointofeachmethod). suggestedbythemanufacturer(thisreferstothelastbulletpointofeachmethod). Th

Thisis imimplplieiess ththatat ththee vovolulumeme toto bebe ininfufusesedd ofof ththee ininfufusisionon pupumpmp wawass memeasuasureredd su

succccesessfsfulullyly foforr alalll fifiveve memeththodods.s. MeMeththodod 33 && 4,4, hohowweveverer,, wwereree nonott ususeded foforr accuracyanalysisbecausetheyweresingledatacollection.

accuracyanalysisbecausetheyweresingledatacollection.

Asseenintheresults,theflowrateaccuracyisdependentonthelengthofthetest. Asseenintheresults,theflowrateaccuracyisdependentonthelengthofthetest. Me

Meththodod 11 (1(10.0.55 miminunutetes)s) hahadd anan exexperperimimententalal toto tatargrgetet ererrororr ofof 3.3.0%0% ±± 0.0.4545%.%. Similarly,Method2(6minutes)hadanerrorof4.43%±0.43%.Finally,Method5 Similarly,Method2(6minutes)hadanerrorof4.43%±0.43%.Finally,Method5 hadanerrorof2.2%±0.2%(60minutes). hadanerrorof2.2%±0.2%(60minutes). ComparingthethreemethodsillustratesthatMethod5isthemostaccurateofthe ComparingthethreemethodsillustratesthatMethod5isthemostaccurateofthe th

threreee teteststs,s, andand itit isis duduee ititss lolongngerer ininfufusisionon titimeme.. ThThererefeforore,e, ththee acaccucuraracycy ofof ththee infusionrateoftheBaxterFlo-Gard6201iswithin2.2%±0.2%. infusionrateoftheBaxterFlo-Gard6201iswithin2.2%±0.2%.

9.Recommendation/FutureWork

Theaccuracymeasurementforinfusionrateisaverysimpleprocedure.Adigital Theaccuracymeasurementforinfusionrateisaverysimpleprocedure.Adigital lethat

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10.Bibliography

Chan,A.(2013).

Chan,A.(2013).InfusionDevicesInfusionDevices.RetrievedFebruary2013,fromUBCCHBE:.RetrievedFebruary2013,fromUBCCHBE:

ww.chbe.ubc.ca:https://courses.chbe.ubc.ca/manhat2012-bin/send_file?crs=BMEG/BMEG530550&id=dmmpqywl9mSaH3&user=ac8994&fna bin/send_file?crs=BMEG/BMEG530550&id=dmmpqywl9mSaH3&user=ac8994&fna me=fil_01282013100001_9QgHhZ&info=inf_01282013100001_DI86nc&attach=1&g me=fil_01282013100001_9QgHhZ&info=inf_01282013100001_DI86nc&attach=1&g rp=4&ext=.pdf rp=4&ext=.pdf Ferrari,R.,&Beech,D.R.(1995).Infusionpumps:guidelinesandpitfalls.

Ferrari,R.,&Beech,D.R.(1995).Infusionpumps:guidelinesandpitfalls. Australian Australian Prescriber

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AppendixA

AppendixA:Method1Data

:Method1Data

Ti

Timeme((miminunutete)) WeWeigightht((g)g) VoVolulumeme((mLmL))

0 0..55 11..44 11..33997722 1 1 33..1155 33..11443377 1 1..55 44..88 44..77990044 2 2 66..4499 66..4477770022 2 2..55 88..2211 88..1199335588 3 3 99..8855 99..88330033 3 3..55 1111..6677 1111..6644666666

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AppendixB

AppendixB:Method2

:Method2

Ti

Timeme((miminunutete)) VoVolulumeme((mLmL))

0 0..55 11..66 1 1 33..44 1 1..55 55..11 2 2 66..88 2 2..55 88..66 3 3 1100..44 3 3..55 1122

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AppendixC

AppendixC:Method3&M

:Method3&Method4

ethod4

Method3 Method3 Totaltimetoinfuse25mL=429seconds Totaltimetoinfuse25mL=429seconds Method4 Method4 Volumetobeinfused(Target)=35mL Volumetobeinfused(Target)=35mL Experimentalvolumeinfused=35.79mL Experimentalvolumeinfused=35.79mL Timetoinfuse=630seconds Timetoinfuse=630seconds

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AppendixD

AppendixD:Method5

:Method5

Ti

Timeme((miminunutete)) WeWeigightht((g)g) VoVolulumeme((mLmL))

3 3 66..3322 66..3300773366 6 6 1122..7722 1122..6699445566 9 9 1199..11 1199..00661188 1 122 2255..5544 2255..4488889922 1 155 3311..8888 3311..8811662244 1 188 3388..4466 3388..3388330088 2 211 4444..8822 4444..7733003366