cadd -prizm Ambulatory Infusion Pump - Optionone€¦ · CADD-Prizm® Ambulatory Infusion Pump...

CADD-Prizm®

Ambulatory Infusion PumpModel 6100 and Model 6101

Technical Manual

Table of Contents

1. Introduction............................................... 1LimitedWarranty..............................................1ExposuretoRadiationorMagneticResonanceImaging(MRI)...................................................1

2. CADD‑Prizm®Pump................................. 2DeliveryModes.................................................3Specifications(Nominal)..................................5

3. Batteries................................................... 8BatteryCompatibility.......................................8DURACELL®AlkalineBatteryLife...................8ULTRALIFE®LithiumBatteryLife....................8

4. Construction........................................... 10

5. TheoryofOperation................................ 11KeyboardCircuitry.......................................... 11DataMemoryEEPROM.................................. 11BatteryBackedRAM...................................... 11TimeBaseCircuitry........................................ 11LCDCircuitry.................................................. 11LEDStatusIndicators.................................... 11FlashPROMTechnology................................ 12GateArrayCircuitry........................................ 12AudibleAlarmCircuitry.................................. 12WatchdogTimerCircuit................................. 12MotorDriver/MotorWatchdogCircuit........... 12PowerCircuitry............................................... 13VoltageReferenceCircuit............................... 13PumpingMechanism..................................... 14PumpingCharacteristics............................... 14AirDetector.................................................... 15UpstreamOcclusionSensor.......................... 15

6. SafetyFeaturesandFaultDetection...... 16HardwareSafetyFeatures............................. 16WatchdogTimerCircuit................................. 16MotorDriver/MotorWatchdogCircuit........... 16Cassette‘Type’SensorCircuit....................... 17Latch/LockSensorCircuit............................. 17VoltageDetectorCircuit................................. 17SoftwareSafetyFeatures............................... 18

7. HardwareandSoftwareFaultDetection 19Overview......................................................... 19OrderofErrorCodeEvents............................ 19

8. CleaningandInspectionProcedures...... 20InspectionRecommendation......................... 20Cleaning......................................................... 20VisualInspection............................................ 20MechanicalInspection................................... 21

9. TestingProcedures................................. 22FunctionalTesting.......................................... 22AirDetectorTest(ifApplicable)..................... 25OcclusionTests.............................................. 25AccuracyTesting............................................ 26CleaningandFunctionalTestingChecklist... 29

Fordetailedinstructions,specifications,warnings,warrantiesandadditionalinformationonoperatingCADD®pumps,pleaserefertotheOperator’s Manualsuppliedwiththeproduct.IfyouhaveadditionalcommentsorquestionsconcerningtheoperationofCADD®pumps,pleasecallthisnumber:1‑800‑258‑5361.Ourstaffisavailabletohelpyou24hoursadaywiththeprogrammingandoperationofCADD®pumpinfusionsystems.

TheissuedateofthisTechnicalManualisincludedfortheuser’sinformation.Intheeventoneyearhaselapsedbetweentheissuedateandproductuse,theusershouldcontactSmithsMedicaltoseeifalaterrevisionofthismanualisavailable.

Issue Date: November 2010

1

1 Introduction

TheTechnicalManualisintendedtoprovideabasic,butlimited,understandingofthemechanicalandelectricaloperationoftheCADD‑Prizm®ComputerizedAmbulatoryDrugDeliverypumptopersonsfamiliarwiththisdevice.TheCADD‑Prizm®Operator’s Manualshouldbeusedinconjunctionwiththispublicationforcompleteinformation.

ThismanualalsooutlinescleaningandfunctionaltestingproceduresthatcanbeperformedontheCADD‑Prizm®pump.

ThistechnicalmanualisapplicabletoboththeCADD‑Prizm®PCSandCADD‑Prizm®VIPpumps.ForinformationontheCADD‑Prizm®PCSpumprefertotheinformationregardingtheCADD‑Prizm®VIPPCAapplicationinthismanual.TestingproceduresinthebackofthismanualareintendedtobeperformedwiththepumpinthePCAdeliverymode.

IMPORTANT NOTICE

CADD‑Prizm®pumpoperationsandsafetyfeaturesarebasedonamicrocomputerdesign.Inadequateservicingortamperingwiththesafetyfeaturesofthepumpmayseriouslyaffectperformanceandsafety.

Forthatreason,All servicing and repair of the CADD-Prizm® pump must be performed by Smiths Medical or its authorized agents.

Themanufacturer’swarrantyagreementshallbecomenullandvoidifthepumpisnotusedinaccordancewiththeOperator’s ManualandInstructionsforUseforthepumpaccessories;or,thepumpisservicedbypersonsotherthanSmithsMedicalorthoseauthorizedbySmithsMedical.

Limited WarrantyThelimitedwarrantyassociatedwiththeCADD‑Prizm®pumpcanbefoundintheproductliteraturesuppliedwiththeproductwhenoriginallypurchased,whichisincorporatedhereinbyreference.Smiths Medical specifically disclaims any other warranty, whether express, implied or statutory, including, without limitation, any implied warranty of merchantability or fitness for use.SmithsMedicalfurtherdisclaimsresponsibilityforthesuitabilityofthesystemforaparticularmedicaltreatmentorforany

medicalcomplicationsresultingfromtheuseofthesystem.Themanufacturershallnotberesponsibleforanyincidentaldamagesorconsequentialdamagestoproperty,lossofprofits,orlossofusecausedbyanydefectormalfunctionofthesystem.

Ifyouwishtoreceiveadditionalinformationabouttheextentofthewarrantyontheseproducts,pleasecontactyourSmithsMedicalrepresentativeorcallCustomerServiceat1‑800‑258‑5361.

Allrecommendations,informationandliteraturesuppliedbySmithsMedicalwithrespecttotheCADD®productlinearebelievedtobeaccurateandreliable,butdonotconstitutewarranties.Noagent,representative,oremployeeofSmithsMedicalhasauthoritytobindSmithsMedicaltoanyrepresentationorwarranty,expressedorimplied.

Exposure to Radiation or Magnetic Resonance Imaging (MRI)

CAUTIONS

1 The pump SHOULD NOT BE DIRECTLY IRRADIATED by therapeutic levels of ionizing radiation because of the risk of permanent damage to the pump’s electronic circuitry. The best procedure to follow is to remove the pump from the patient during therapeutic radiation sessions or diagnostic levels of radiographic and fluoroscopic radiation. If the pump must remain in the vicinity during a diagnostic or therapy session, it should be shielded, and its ability to function properly should be confirmed following treatment.

2 Magnetic fields produced by magnetic resonance imaging (MRI) equipment may adversely affect the operation of the pump. Remove the pump from the patient during MRI procedures and keep it at a safe distance from magnetic energy.

2

2 CADD-Prizm® Pump

Figure1.FrontandbackviewsoftheCADD‑Prizm®pump.

Delivery ModesTheCADD‑Prizm®pumpprovidesmeasureddrugtherapytopatientsinhospitaloroutpatientsettings.TheCADD‑Prizm®pumpisindicatedforintravenous,intra‑arterial,subcutaneous,intraperitoneal,epiduralspaceorsubarachnoidspaceinfusion.Epiduraladministrationislimitedtoshort‑terminfusionofanestheticsandeitherlong‑orshort‑terminfusionofanalgesics.Subarachnoidadministrationislimitedtoshort‑terminfusionofanalgesics.Thepump’sflexibilityallowsittobeusedinavarietyof

settings.TheCADD‑Prizm®VIP(VariableInfusionProfile)pumpmaybeprogrammedtodelivermedicationinoneoffourdeliverymodes:(1)PCA(patient‑controlledanalgesia)(2)Continuous(3)Intermittentand(4)TPN(totalparenteralnutrition)(SeeFigures2through5).TheCADD‑Prizm®PCS(PainControlSystem)pumpmaybeprogrammedtoprovidepatient‑controlledanalgesiatherapy.Figure1showsadiagramoftheCADD‑Prizm®pump.

Pantone 653 Dk Blue

Pantone 654 Extra Dk

Pantone 519 Purple

NO AIRDETECTORINSTALLED

STARTSTOP

YNLOCK

DOSE

NEXT

ENTER OPTIONS

?

Power

Data In/Out

AmberGreen

Display

Keypad

PowerJack

DataIn/OutJack

AirDetectorPortCover

AirDetector(optional)

PolemountBracketRecess

BatteryCompartment

CassetteLock

Cassette

CassetteLatch

®

UpsteamOcclusionSensor(Model6101only)

Rear ViewFront View

Indicator Lights

3

Figure2.PCAmodedeliveryprofile.

Clinician Bolus(used here as a loading dose)

Demand DosesContinuous Rate

Time

Dos

age

Figure3.Continuousmodedeliveryprofile.

Figure4.Intermittentmodedeliveryprofile.

Figure5.TPNmodedeliveryprofile.

PCA Delivery Profile

ThePCA(patient‑controlledanalgesia)deliverymodeisusedfortherapiesthatrequireacontinuousrateofinfusion,patient‑controlleddemanddosesorboth,suchaspatient‑controlledanalgesia.

Continuous Mode Delivery Profile

TheContinuousdeliverymodeallowstheinfusionofdrugataconstant,programmedrate.

Intermittent Mode Delivery Profile

TheIntermittentdeliverymodeallowstheinfusionofaspecificvolumeofdrugataregularprogrammedinterval.

TPN Mode Delivery Profile

TheTPN(totalparenteralnutrition)deliverymodeallowstheinfusionofnutritionalsolutionsorotherfluids,withoptionaltaperingatthebeginningandendofinfusion,andanoptionalKVO.

DeliveryRate

(ML/HR)

TimeContinuous Delivery

DeliveryRate

(ML/HR)

TimeContinuous Delivery

Infusion Period

Time

INFUSION VOLUME

KVO Rate5 ML/HR

Delivery Rate

(ML/HR)

Taper-Down Period (Optional)

Taper-UpPeriod (Optional)

4

Milligrams

Table1.PCAdeliverymode:continuousratescrollranges.

Table2.Demanddose,clinicianbolusscrollranges,milligrams

Table3.Demanddose,clinicianbolusscrollranges,micrograms

Units Starting Increment Maximum

Milliliters 0.10 0.10 30.00

Milligrams& 10%of Mg only:Valuesbetween0.01and0.5: 0.01 Concentration

Micrograms concentration Mcg only: Valuesbetween0.1and0.5: 0.1 x30

Valuesbetween0.5and100: 0.1

Valuesbetween100and1000: 1.0

Valuesgreaterthan1000: 10.0

PCA Delivery Mode Scroll Ranges

Table4.PCAdeliverymode:Demanddose,clinicianbolusscrollranges,milliliters

0.1 0.01 0.99 0.01 2 0.2 0.02 1.98 0.02 4 0.3 0.03 2.97 0.03 6 0.4 0.04 3.96 0.04 8 0.5 0.05 4.95 0.05 10 1 0.05 9.9 0.05 20 2 0.10 19.8 1.10 40 3 0.15 29.7 1.15 60 4 0.20 39.6 0.20 80 5 0.25 49.5 0.25 100 10 0.50 99.0 0.50 200 15 0.75 148.5 0.75 300 20 1.00 198.0 1.00 400 25 1.25 247.5 1.25 500 30 1.50 297.0 1.50 600 35 1.75 346.5 1.75 700 40 2.00 396.0 2.00 800 45 2.25 445.5 2.25 900 50 2.50 495.0 2.50 1000 55 2.75 544.5 2.75 1100 60 3.00 594.0 3.00 1200 65 3.25 643.5 3.25 1300 70 3.50 693.0 3.50 1400 75 3.75 742.5 3.75 1500 80 4.00 792.0 4.00 1600 85 4.25 841.5 4.25 1700 90 4.50 891.0 4.50 1800 95 4.75 940.5 4.75 1900 100 5.00 999.0 5.00 2000

Concentration mg/ml

Demand Doseincrement max.

Clinician Bolusincrement max.

1 0.05 9.9 0.05 20 2 0.10 19.8 0.10 40 3 0.15 29.7 0.15 60 4 0.20 39.6 0.20 80 5 0.25 49.5 0.25 100 10 0.50 99.0 0.50 20 15 0.75 148.5 0.75 300 20 1.00 198.0 1.00 400 25 1.25 247.5 1.25 500 30 1.50 297.0 1.50 600 35 1.75 346.5 1.75 700 40 2.00 396.0 2.00 800 45 2.25 445.5 2.25 900 50 2.50 495.0 2.50 1000 55 2.75 544.5 2.75 1100 60 3.00 594.0 3.00 1200 65 3.25 643.5 3.25 1300 70 3.50 693.0 3.50 1400 75 3.75 742.5 3.75 1500 80 4.00 792.0 4.00 1600 85 4.25 841.5 4.25 1700 90 4.50 891.0 4.50 1800 95 4.75 940.5 4.75 1900 100 5.00 990.0 5.00 2000 200 10.00 1980.0 10.00 4000 300 15.00 2970.0 15.00 6000 400 20.00 3960.0 20.00 8000 500 25.00 4950.0 25.00 10000

Micrograms

Concentration mg/ml

Demand Doseincrement max.

Clinician Bolusincrement max.

Demand Dose Clinician Bolus increment max. increment max. 0.05 9.9 0.05 20

Milliliters

5

Specifications (Nominal)

General Pump Specifications

ResolutionCADD™medicationcassettereservoirorCADD®administrationset,0.050ml/pumpstrokenominal

CADD‑Prizm®highvolumeadministrationset,0.100ml/pumpstrokenominal

Size4.4cmx10.4cmx14.1cm(1.7inx4.1inx5.6in)excludingcassetteorotheraccessories

Weight 568g(20oz.)including9‑voltbatteryandempty100‑mlCADD™medicationcassettereservoir,excludingotheraccessories

Pump Alarms Lowbatterypower;depletedbatterypower;externalpowersourcelow,faulty,depleted;pumpstopped;pumpfault;lowreservoirvolume;highdeliverypressure;airinline;airdetectorfaultyordetached(onlywiththeuseoftheoptionalairdetector);airdetectorportcoverdetached;deliverytooslow;keystuck;cassettedetachedorunlocked;printfailure,upstreamocclusion(model6101only)

Bolus Volume at Occlusion Alarm Pressure0.050mlresolutionsets/reservoirs:<0.25ml0.100mlresolutionsets:<2.0ml

Power Sources 9‑voltalkalineorlithiumbatterysuchasDURACELL®AlkalineMN1604orULTRALIFE®LithiumU9VL;PowerPackreordernumber21‑3801;ACadapter.

Aninternalbatterypowerstheclock.Whenitisdepleted,itcannotreliablymaintaintheclocktime.Thisbatterymustbereplacedbythemanufacturer.Theinternalbatteryhasanexpectedlifeof5years.

System* Operating Temperature+2°Cto40°C(36°Fto104°F)

System* Storage Temperature ‑20°Cto60°C(‑4°Fto140°F)

Power Pack Charging Temperature+10°Cto35°C(50°Fto95°F)

System* Delivery Accuracy ±6%(nominal)

High Pressure Alarm18±9psi

Air Detector Alarm Singlebubblegreaterthan0.100ml

PCA Delivery Mode Specifications

Reservoir Volume1to9999orNotInUse;programmablein1mlincrements,displayedin0.1mlincrementsDefault:1ml

UnitsMilliliters(ml),milligrams(mg),micrograms(mcg)Default:milligrams

ConcentrationMg/ml:0.1,0.2,0.3,0.4,0.5,1,2,3,4,|5,10,15,...95,100Mcg/ml:1,2,3,4,5,10,15,...95,100,200,300,400,500Default:1mg/ml

Continuous Rate 0to30ml/hr(orthemgormcgequivalent)(SeeTable1forscrollranges)Default:0mg/hr

Demand Dose 0to9.9ml(orthemgormcgequivalent)(SeeTables2,3and4forscrollranges)Default:0mg/hrDeliveryrate(ContinuousRate+DemandDose):125ml/hrnominal

Demand Dose Lockout5minutesto24hoursinthefollowingincrements:1minuteforvaluesbetween5and20minutes5minutesbetween20minutesand24hoursDefault:5minutes

Max Doses Per Hour1to12dosesin1doseincrements(willalsobelimitedbytheDemandDoseLockoutvalue)Default:1

*SystemisdefinedasaCADD‑Prizm®pumpwithanattachedCADD™medicationcassettereservoirandCADD®extensionsetwithintegralanti‑siphonvalve,oranattachedCADD®administrationsetwithintegraloradd‑onanti‑siphonvalve.

6

Demand Doses Given0to999

Demand Dose Attempts0to999

Given0to99999.99in0.01unitincrements

Clinician Bolus 0.1mlto20.00ml(ormgormcgequivalent)(SeeTables2,3and4forscrollranges)Deliveryrate(ContinuousRate+ClinicianBolus):125ml/hrnominal

Continuous Delivery Mode Specifications

Reservoir Volume1to9999orNotInUse;programmablein1mlincrements,displayedin0.1mlincrementsDefault:1ml

Continuous Rate0.1to350ml/hrinthefollowingincrements:0.1forvaluesbetween0.1and1001forvaluesbetween100and350Default:0ml/hrUse9‑voltbatteryforratesupto250ml/hr;usepowerpackorACadapterforratesupto350ml/hr


TPN Delivery Mode Specifications Reservoir Volume10.0to9990orNotInUse;programmablein1mlincrements,displayedin0.1mlincrementsDefault:10ml

Infusion Volume10to9990mlin10mlincrements:Default:10ml

Infusion Period0hrs10minto99hrs50minin10minuteincrements:Default:1hr0min

Taper-Up Period0hrs0minto99hrs40minin10minuteincrements:Default:0hrs0min

Taper-Down Period0hrs0minto99hrs40minin10minuteincrements:Default:0hrs0min

Plateau RateCalculatedbypump;10to350ml/hrUse9‑voltbatteryforratesupto250ml/hr;usepowerpackorACadapterforratesupto350ml/hr

KVO RateCalculatedbypump:1/10ofPlateauRateupto5ml/hr

Given0to99999in0.1unitincrements

Intermittent Delivery Mode SpecificationsReservoir Volume1to9999orNotInUse;programmablein1mlincrements,displayedin0.1mlincrementsDefault:1ml

Dose Volume0.1to1000mlinthefollowingincrements:0.1forvaluesbetween0.0and1001forvaluesbetween100and1000Default:0.0ml

Dose Duration1minto24hrsinthefollowingincrements:1minuteforvaluesbetween1minand10min5minutesforvaluesabove10minDefault:30minDurationislimitedbyDoseVolumesothatratedoesnotexceed350ml/hr.Use9‑voltbatteryforratesupto250ml/hr;usepowerpackorACadapterforratesupto350ml/hr

Dose Cycle10minto96hrsin5minuteincrements:Default:4hrs

KVO Rate0to10ml/hrin0.1ml/hrincrementsDefault:0ml/hr

Next Dose Start Time10minto96hrsXmin(whereXequalsa10minuteincrementinthe96thhour)orImmediate;programmablein10minuteincrementsDefault:Immediate


Time RemainingDoseandCycledisplayin1minuteincrements

7

Options Specifications

Immediate Taper-Down (TPN)0totimeremainingintheinfusionperiod,in10minuteincrements(defaultstothecurrentlyprogrammedTaper‑Down)

AutoLock NotInUse,LL1orLL2

Time 00:00to23:59

Air Detector TurnedOnorTurnedOff

Event Log 0to500events

Extended History Upto48hoursin1hourincrements

Biomed Toolbox Specifications

MicrogramsOnorOff

Extended HistoryOnorOff

Max Dose per HourOnorOff(PCAsoftwarerev.6210Gorhigheronly)

PM (Preventive Maintenance) Reminder 1to24monthsin1monthincrements,NotInUse

Custom Lock Level Code 1to899(excludingpresetcode)inincrementsof1

Date Format USStandard(mm/dd/yy)orEuropeanStandard(dd/mm/yy)

Power Source DisplayAlwaysdisplayoronlyLowBattery

Upstream SensorOnorOff(Model6101only)

Air Detector Required RequiredorNotRequired

Defaulting the Lock Level CodeThestandardLockLevelCode(061)canbechangedtoacustomizedcodeusingthe

BiomedToolboxCustomLockCodefeature.SeetheOperator’s ManualsuppliedwiththepumpforinstructionsoncustomizingtheLockLevelCode.IfitbecomesnecessarytochangeacustomizedcodebacktothestandardLockLevelCode,dothefollowing:

1. PresstheLOCKkeytwice2. Scrollto9113. PresstheOPTIONSkey

Compatible Reservoirs and Administration Sets

•50‑mlor100‑mlCADD™medicationcassettereservoir,usedwiththeCADD®extensionsetwithanti‑siphonvalve.

•CADD®administrationsetwithintegralanti‑siphonvalve,withorwithoutbagspike(allowsuseofflexibleplasticbagorsterilevialwithinjector)

•CADD®administrationsetwithaddonanti‑siphonvalveandbagspike(allowsforgravityprimingbeforeattachingtheaddonanti‑siphonvalve)

•CADD®administrationsetwithaddonanti‑siphonvalve,withorwithoutair‑eliminatingfilter

Remote Dose CordSmithsMedicalprovidesaRemoteDoseCordforthePCAdeliverymode,whichisanextensionoftheDOSEkey.ThepushbuttonswitchisaSinglePoleDoubleThrow(SPDT)whichoperatesinthesamemannerastheDOSEkey.WhentheRemoteDoseCordisattachedtothepump,thepatientmaypresseithertheRemoteDosebuttonortheDOSEkeytoreceiveaDemandDose.TheclinicianmayalsouseeithertheRemoteDosebuttonortheDOSEkeytodeliveraclinicianbolus.Foreasyaccess,theRemoteDosecordmaybefastenedtothepatient’sclothingorbedsheetwiththeattachedclip.

NOTETo detach the Remote Dose cord from the pump, grasp the Remote Dose cord connector and pull back using a straight, steady motion. Do not twist or turn the connector, or use any instrument to remove it. For additional specifications refer to the Operator’s Manual provided with the product.

8

Battery Compatibility

Recommended Batteries

Nine‑voltalkalineorlithiumbatteriesarerecommendedforuseintheCADD‑Prizm®pump.Carbon‑zinc,mercury,nickel‑cadmium,orzinc‑air9‑voltbatteriesshouldnotbeused.

Battery Life

TheCADD‑Prizm®pumphasbeendesignedtoprovideoptimalbatterylife.TheexpectedbatterylifeintheCADD‑Prizm®pumpdependsonthefollowingfactors:• Programmeddeliveryrate• Operatingtemperatures• Frequencyofdisplaybacklighting• Frequencyofprinting• Batterytypeandbrand• Batteryage

DURACELL® Alkaline Battery LifeThefollowingtablesmaybeusedtopredicttypicalalkalinebatterylifeatdifferentdeliveryrateswhenanalkalinebatteryisusedintheCADD‑Prizm®pump.Asexpected,batterylifedecreasesasthedeliveryrateincreases.ThesetablesarebasedonlaboratorytestsusingfreshDURACELL®alkalinebatteriesinCADD‑Prizm®pumpswhilethepumpswereoperatingatroomtemperature.

Actualbatterylifemaybesignificantlyshorterdependingontheoperatingtemperatureandthestorageconditionsofthebattery.

Batterylifeisshortenedsignificantlyatverylowoperatingtemperatures.Forexample,at0°C(32°F),analkalinebatterywillyieldapproximately30%ofitsnormalcapacity.

Alkalinebatteriesdonotneedtobestoredinarefrigerator.Afterfouryearsofstorageat21°C(70°F),analkalinebatteryretainsapproximately86%ofitsoriginalcapacity.Batterylifewillbeshorterifthebatteryisstoredaboveroomtemperature.Analkalinebatterystoredat43°C(110°F)willbedowntoapproximately80%ofitscapacitywithinoneyear.

3 Batteries

Recommendedstorageconditionsare10°Cto25°C(50°Fto77°F)withnomorethan65%relativehumiditynoncondensing.

ThefollowingtablesarebasedonlaboratorytestsconductedatroomtemperatureusingfreshDURACELL®alkalinebatteriesandaCADD®administrationset.Actualbatterylifewillvarydependingonthebrandofbattery,batteryshelflifeandtemperatureconditions.

ULTRALIFE® Lithium Battery LifeThefollowingtablesmaybeusedtopredicttypicallithiumbatterylifeatdifferentdeliveryrateswhenalithiumbatteryisusedintheCADD‑Prizm®pump.Asexpected,batterylifedecreasesasthedeliveryrateincreases.ThesetablesarebasedonlaboratorytestsusingfreshULTRALIFE®lithiumbatteriesinCADD‑Prizm®pumpswhilethepumpswereoperatingatroomtemperature.

Actualbatterylifemaybesignificantlyshorterdependingontheoperatingtemperatureandthestorageconditionsofthebattery.Lithiumbatterylifeisdependentuponthetemperatureandrelativehumidityofstorage.Recommendedstorageconditionsarelessthan20°C(68°F)withadesiccanttoensurelessthan10%relativehumidity.

ThefollowingtablesarebasedonlaboratorytestsconductedatroomtemperatureusingfreshULTRALIFE®lithiumbatteriesandaCADD®administrationset.Actualbatterylifedependsuponthebrandofbatteryselected,theparticularbatteryselected,batteryshelflife,andtemperatureconditions.SmithsMedical’stestingindicatesalargevariabilityinbatterylife.

9

Rate Life Volume 0.4ml/hr 120hrs 48ml 10ml/hr 86hrs 860ml 30ml/hr 37hrs 1110ml 50ml/hr 26hrs 1300ml 100ml/hr 13hrs 1300ml 200ml/hr 14hrs 2800ml 350ml/hr 7hrs 2450ml Table4.9‑voltAlkaline‑typebatteriesusedwiththeCADD‑Prizm®pump.

Rate Life Volume

0.4ml/hr 212hrs 85ml 10ml/hr 161hrs 1610ml 30ml/hr 79hrs 2370ml 50ml/hr 60hrs 3000ml 100ml/hr 30hrs 3000ml 200ml/hr 32hrs 6400ml 350ml/hr 17hrs 5950ml Table5.9‑voltLithium‑typebatteriesusedwiththeCADD‑Prizm®pump.

Continuous and PCA Delivery Battery Life (Max Delivery Rate PCA Mode 30 ml/hr)Note: Results are without air detector.

Table6.EPSSystemusedwiththeCADD‑Prizm®pump.

Rate Life Volume

100ml/hr 64hrs 6400ml 200ml/hr 67hrs 13400ml 350ml/hr 39hrs 13650ml

Intermittent Delivery Battery LifeNote: Results are without air detector.

Volume Duration Cycle KVO Life Volume

23.5 1:00hr 5:00hr 0.2ml/hr 301hrs 1229ml 61 1:00hr 6:00hr 0.2ml/hr 183hrs 1891ml 125 1:00hr 6:00hr 0.2ml/hr 120hrs 2520ml 200 1:00hr 12:00hr 0.2ml/hr 186hrs 3134ml

Table8.9‑voltLithium‑typebatteriesusedwiththeCADD‑Prizm®pump.

Volume Duration Cycle KVO Life Volume

23.5 1:00hr 5:00hr 0.2ml/hr 117hrs 477ml 61 1:00hr 6:00hr 0.2ml/hr 71hrs 733ml 125 1:00hr 6:00hr 0.2ml/hr 38hrs 798ml 200 1:00hr 12:00hr 0.2ml/hr 84hrs 1415ml

Table7.9‑voltAlkaline‑typebatteriesusedwiththeCADD‑Prizm®pump.

TPN Delivery Battery LifeNote: Results are without air detector.

Volume Period TaperUp TaperDown KVO Life Volume

2000 10:00hr 1:00hr 1:00hr 5ml/hr 12hr 2333ml 3000 10:00hr 1:00hr 1:00hr 5ml/hr 8hr 2497ml

Table9.9‑voltAlkaline‑typebatteriesusedwiththeCADD‑Prizm®pump.



Table10.9‑voltLithium‑typebatteriesusedwiththeCADD‑Prizm®pump.



Table11.EPSSystemusedwiththeCADD‑Prizm®pump.

10

4 Construction

ThecustomLiquidCrystalDisplay(LCD),alsolocatedonthefronthousing,showsthepumpstatusandprogrammedsettings.Thedotmatrixdisplayconsistsof21charactercolumnswith4rowsofcharacters,andisselectedbythepump’smicroprocessoraccordingtostatusconditionsandkeyboardentries.

Themicroprocessorandothercircuitrywhichcontrolthepumparelocatedontwoprintedcircuitboards.ThemicroprocessorboardcontainstheCentralProcessingUnit(CPU)anditsassociatedcircuitry,motordrivercircuitry,andothermiscellaneouscircuitry.TheLCDboardcontainstheLiquidCrystalDisplaywithitsassociatedcircuitry,andthebacklightmodulewithitsassociatedcircuitry.

Thepumpingmechanismsubassemblycontainsthemotor,geartrain,camshaft,valves,expulsor,sensingdisk,infraredlightsource,infrareddetector,occlusionsensor,cassettesensors,lockandlatch.Viathemotordrivercircuitry,thepump’smicroprocessorcontrolsmotorrotation.

Twoexternalportconnectorsareutilizedforcommunicationandexternalpowerinput.Oneoftheseconnectors,thedatain/outjack,isusedforattachmentoftheRemoteDosecord.ThisenablesthepatienttouseeitheroftwooptionstobeginaDemandDosewhenusingthePCAdeliverymode:(1)theRemoteDosebutton;or(2)theDOSEkey.

Thisjackcanalsobeconnectedtoanexternalprinterviatheinterfacecable.Withthisfeature,thepatientorcliniciancanprintvariouspumpreports.Thesecondportisforexternalpowerconnection.Thisport,thepowerjack,canreceiveinputfromeitheranACadapterortheExternalPowerSourcerechargeablepowerpack.

Connectionsbetweentheprintedcircuitboardsaredesignedforeaseofmanufacturingandserviceability.Thekeyboardisconnectedtothemicroprocessorboardviaaflexcircuittail.Flexiblecircuitryanddiscretewiresconnectthepumpingmechanism,motor,andsensorstotheprintedcircuitboards.

Thepump’shousingismadeofaspecialhighimpactplasticdesignedtoreduceinterferencefromelectromagneticfieldsandtodissipateelectrostaticdischarge.Itiscomposedoftwosections:thebaseandcoverhousing.Thepumphousingissealedtoensurethatthepumpiswaterresistant.Thebatterycompartmentisnotwaterresistant.

NOTEThe CADD-Prizm® ambulatory infusion pump is water resistant, but not waterproof.

Thebatterycompartmentisaccessedthrougharemovabledooronthesideofthebasehousing.Withinthebatterycompartmentisspaceforthebatteryandthetwobatterycontacts.

TheCADD™medicationcassettereservoirortheadministrationsetisattachedtothebottomofthepumpbyinsertingthetwohooksonthecassetteintothematinghingepinsonthepump.Thepumpandthereservoirortheadministrationsetarethenplacedinanuprightpositiononafirm,flatsurface.Thereservoirortheadministrationsetcanbelatchedinplacebyinsertingacoinintheslotonthepump’slatchingbutton,pushingthebuttonin,andturningthebuttonone‑quarterturncounterclockwise.Thereservoirortheadministrationsetislockedintoplacebyinsertingakeyintothepump’slockandturningthelockone‑quarterturncounterclockwise.

NOTE The cassette lock must be unlocked before attempting to unlatch the disposable.

NOTEThe CADD™ medication cassette reservoir and the administration set are intended for single use only.

Thekeyboard,locatedonthefronthousing,iscomposedofninemembraneswitchesandissealedagainstmoisture.Allofthekeyscontaindomestoprovideatactilefeelwhenthekeyispressed.Thekeyboardkeysaresensedbythepump’smicroprocessor.

11

5 Theory of Operation

Keyboard CircuitryTheCADD‑Prizm®pumpiscontrolledbyamicroprocessor.Theactionsofthemicroprocessorarecontrolledbyaprogram,whichiscontainedinthememory.

CommandsareissuedtothemicroprocessorfromtheuserviatheninekeysonthekeyboardandtheRemoteDosecord.ThekeysonthekeyboardfeedindividuallyintotheGateArrayonthemicroprocessorboard.AkeyclosureappliesagroundtotheassociatedinputoftheGateArray.KeydebouncecircuitryresidentintheGateArrayprovidesacleanoutputsignaltothemicroprocessorforthedurationofthekeyclosure.ThemicroprocessorreadskeyboardstatusbyaccessingspecialmemorylocationsintheGateArray.

TheRemoteDosebuttonconsistsofanSPDTswitchwithitsowndedicatedinputtothemicroprocessorcircuitry.Theswitchhasacommoninputlineandtwooutputsignallines.Thetwosignallinesarecomplementarysuchthatonelineisalwayslogichighandtheotherisalwayslow.WhentheRemoteDosebuttonispressed,bothsignallineschangetothealternatelogicstate.Thisredundancypreventsasinglelinefailurefromstartingadosedelivery.

Data Memory EEPROMManysettingsofthepump’sdeliveryandrecordkeepingparametersarestoredbythemicroprocessorinanElectricallyErasableProgrammableReadOnlyMemory(EEPROM).Datatoandfromthememoryispresentedserially.WheneverthemicroprocessorusesdatafromtheEEPROM,thedataischeckedforvalidity.

Battery Backed RAMAdditionalsettingsofthepump’sdeliveryandrecordkeepingparametersarestoredinabatterybackedRandomAccessMemory(RAM).Batterybackupisprovidedbytwoprintedcircuitboard‑mountedlithiumbatteries.Thesebatteriesaredesignedtoprovideaminimumoffiveyearsofmemoryretentionduringnormalpumpusage.WheneverthemicroprocessorusesdatafromtheRAM,thedataischeckedforvalidity.

Time Base CircuitryAnaccurate3.6864MHztimebaseisprovidedbyaquartzcrystal.The3.6864MHzsignalisconnectedtothemicroprocessor,whereitisfrequency‑dividedtoaccesstheprogrammemoryatacyclerateof921kHz.

Inaddition,anaccurate32.768kHztimebaseisprovidedbyasecondquartzcrystal.The32.768kHzsignalisusedfortherealtimeclock.

LCD CircuitryThehigh‑impedance,low‑power,specialdrivesignalsfortheliquidcrystaldisplayareprovidedbytheLCD‑drivers.EachalphaornumericcharacterontheLCDisformedbydarkeningcombinationsofdots.CommandstodisplaydotsareissuedviadatabuscommandstotheLCD‑driversbythemicroprocessor.

TheLCDcircuitalsocontainsapowersupplywhichprovidesbiasvoltagetotheLCDpanel.Thisvoltagecontrolstherelativebrightnessofthecharacters.AdditionalcircuitryallowsthemicroprocessortodisabletheLCDwhennotinuseinordertoconservebatterypower.

AtwobrightnesslevelLCDbacklightisprovidedtoimproveLCDviewingunderlowlightconditions.WhenthemicroprocessorenablestheLCD,italsoenablesthelowbrightnessbacklight.Lowbrightnessisusedtoconservebatterypower.IftheACadapterisconnected,themicroprocessorwillenablethehighbrightnessbacklightsincethisdoesnotconsumepowerfromthebattery.

ThebacklightautomaticallyshutsoffwhentheLCDisturnedoff.

LED Status IndicatorsAnamberandagreenLightEmittingDiode(LED)areprovidedunderthepump’sfrontpaneloverlaytoprovidepumpstatustotheuser.Undersoftwarecontrol,theLEDscaneitherflashatalowdutycycleorbeoncontinuously.Aflashingindicatortypicallyindicatesanormalmodeofoperationandasteady“on”indicatortypicallyindicatesafaultcondition.

12

Flash PROM TechnologyProgrammemoryforthepumpisstoredinFlashProgrammableReadOnlyMemory(FlashPROM).Thistypeofmemoryallowsmodificationofthecontentswithoutphysicallyremovingthedevicefromthecircuitboard.Undercertaincircumstances,theprogramcanalsobedownloadedthroughtheI/Oportonthesideofthepump.SeverallayersofredundancyintheprogrammingsystempreventaccidentalerasingormodificationofthePROM.

Gate Array CircuitryTheGateArraycontainscircuitrywhichcontrolsmemoryaddressdecoding,keyboarddebounce,LightEmittingDiode(LED)indicatorstatus,LCDcommandbuffering,BatteryBackedRAMinterface,andmiscellaneoussignallinebufferingfunctions.

Audible Alarm CircuitryAudiblealarmcircuitryconsistsofapiezoelectricdiskandindependentoscillator.Thediskflexesorbendsinresonancewiththeoutputoftheoscillator.Thepiezodiskismountedtothepumphousingtoenhancesoundlevel.Theoscillatorwhichdrivesthepiezodiskiscapableofprovidingtwodrivingfrequencies.Thelowfrequencyisintherangeof700to1500Hzandthehighfrequencyisintherangeof1600to2500Hz.ThemicroprocessorcontrolstheaudiblealarmviacontrollinesfromtheGateArray.Whenthemicroprocessorselectsboththelowandhighfrequencycontrollines,theaudiblealarmentersawarblemodewhereitoscillatesbetweenthelowandhighfrequencysoundatarateof0.8and2Hz.LowbatteryvoltagedetectionandwatchdogtimercircuitryalsohavetheabilitytoenabletheaudiblealarmviatheGateArray.

Watchdog Timer CircuitWatchdogtimercircuitryisprovidedtomonitorthestatusofthemicroprocessoranddisablethemotorandenabletheaudiblealarmifthemicroprocessorfailstofunctionproperly.Themicroprocessormuststrobethewatchdogcircuitatleastonceeverysecondinordertopreventthewatchdogfromperformingitsresetfunction.Theresetoutputfromthewatchdogcircuitisapulseoutput.Thisactsto“jumpstart”themicroprocessor.Thisuniquefeatureallowsthemicroprocessortotestthewatchdog

circuitoneverypower‑up.Bysettingaflaginmemoryandnotstrobingthewatchdog,themicroprocessorcanforceawatchdogtime‑out.Afterbeingreset,themicroprocessorchecksthestatusflagtoseeifthiswasatime‑outtest.Ifso,themicroprocessorcontinuesnormalpower‑upactivities.Iftheresetoccurredwhenthemicroprocessorwasnotexpectingit,themicroprocessortrapstheevent,soundstheaudiblealarmanddisplaysanerrormessageontheLCD.

Motor Driver/Motor Watchdog CircuitMotordrivecircuitryiscomposedofaseriesofpowerFETtransistors,passivecomponents,andtwovoltagecomparators.BuiltintothemotordrivecircuitryisanRCtimerwhichtimeshowlongthemotorrunseachtimeitisturnedon.Ifthemotorrunsformorethananaverageof4seconds,thecircuitwilltimeoutanddisablethemotor.Auniquefeatureofthiscircuitisthatcontrollinestoandfromthemicroprocessorcircuitallowthemicroprocessortoperformacompletefunctionaltestofthemotordrivecircuitwithoutrunningthemotor.Themicroprocessorperformsthistestfunctioneveryseveralminutestoassureitscontinuedfunctionality.Aninputfromthewatchdogcircuitpreventsmotoroperationifthewatchdogtimerexpires.

Rotationofthemotorissensedbythemicroprocessorviaaninfrared‑sensitivephotodetector.Aninfraredlightsourceismountedsothatitslightbeamilluminatestheinfrareddetector.Anopaqueflagismountedconcentricallytothecamshaftandrotateswithitbetweentheinfraredlightsourceanddetector.Whentheflaginterruptsthelightbeam,theoutputofthedetectorissensedbythemicroprocessorviaaninputportbit.PowertotheinfraredLEDlightsourceiscontrolledbythemotordrivercircuitandisoffwhenthemotorisnotrunningtoconservebatterylife.

Inthemicroprocessorsoftware,multiplechecksaremadeonmotionofthecamshaft.Whenthemotoriscommandedtostart,theinfraredsensormustshowthathalfarevolutionhasoccurredwithinfivesecondsandthatthemotorhasstoppedwhenhalfarotationwascompleted.Inaddition,nocamshaftrotationcantakeplacewhenthemotorhasnotbeencommandedtorun.

13

Power CircuitryPowerforthepumpisnormallysuppliedbya9‑voltalkalinebattery,9‑voltlithiumbattery,orACadapter.Thesetypesofbatterieshaveafairlylowinternalresistanceovertheirdischargerange,whichwillkeeppowersupplynoiselow.Othertypesofbatteries,suchascarbon‑zinc,exhibithighinternalresistance,especiallyneardepletion.Avoltagedropacrosstheinternalresistanceoccurswhencurrentisdrawnbythemotorduringpumpactivations.Thiscurrentisdemandedinshortpulseswhenthemotorisfirstturnedonandgenerateslargespikesinthebatteryvoltage.Thisnoisecancausethelowbatterydetectioncircuittoshutdownthepump.

Themotordrivercircuitpoweristakendirectlyfromthebattery,butthemicroprocessoranditsassociatedcircuitryrequirescloselyregulatedandfiltered5‑voltpowerwhichissuppliedfromthemicropowervoltageregulator.Thisregulatorwillsupply5‑voltpoweruntilitsinputvoltageisapproximately5.3volts.Afterthatpoint,theoutputoftheregulatorwillfollowtheinputvoltagedown.

Voltage Reference CircuitAvoltagereferencecircuitprovidesaconstantDCvoltagetothemicroprocessorAnalogtoDigitalConverter(ADC).Byreadingthisinputandcomparingthevaluetoapredeterminedrange,themicroprocessorcanvalidatetheaccuracyofthe5‑voltpowersupply.Variationsinthe5‑voltsupplyleftundetectedcanresultininaccuracyinthelowbatteryalarmsetpointsandvariationsinothercalculatedvalues.

Table12.CADD‑Prizm®pumplowbatteryconditions.†Thepumpemits3beepsevery5minutes,andthemessage“9VoltBatteryLow”appearsonthepump’sdisplay,indicatingthatthebatterypowerislow,butthepumpisoperable.††Thepumpemitsacontinuous,variable‑tonealarm,andthemessage“9VoltBatteryDepleted”appearsonthedisplay,thebatterypoweristoolowtooperatethepump,andpumpoperationhasstopped.

Voltage CADD®PumpStatusTripPoint*

>7.0V Noalarm

6.4–7.0V* Transitiontolowbatterycondition;batterylowmessageappears;3beepsevery5min.†

6.0–6.6V* Transitiontodepletedbatterycondition;batterydepletedmessageappears;continuousalarm††

5.25–5.95V Hardwareresetoccurs.Pumpcontinuestoindicatedepletedbatterycondition.

* Voltagerangesareduetocomponenttolerances.Actualtripvaluesareguaranteedtobenon‑overlapping.

14

Pumping MechanismThepumpingmechanismislinearperistalticwithtwoactivevalves.Pumpingoccurswhentheexpulsorpressesonthereservoirpumptubinginsequencewiththeinletandoutletvalves.Atrest,theoutletvalveispressingdownfullyonthetubingandtheexpulsorandinletvalveareretracted.(SeeFigure7.)

Whenthemicroprocessorcommandsthemechanismtopump,thecamshaftbeginstorotate,thuscontrollingthefollowingpumpcycle:

1.Theinletvalvecloses.2. Insynchronywiththeexpulsormovingdown

tocompressthetubing,theoutletvalveopens,expelling0.050mloffluid(or0.100mloffluidwithaCADD‑Prizm®highvolumeadministrationset)towardthepatient.

3.Theoutletvalvecloses.4.Theinletvalveopensastheexpulsoris

retracted,causingfluidfromthereservoirtoagainfillthepumptubingsegment.

5.Thecamshaftrotationstopsafterhalfarevolutionandthecycleiscompleted.

Pumping CharacteristicsIfthefluidpathtothepatientbecomesblocked,thepumptubingwillexpandaspumpingoccurs.Whentherehasbeenanamountofinflationcorrespondingto124±62kPa(1.24±0.62bar,18±9psi),theocclusionanalogsensortrips,whereuponthemicroprocessorstopsthepumpmechanismandissuesvisualandaudiblealarms.Thusthemaximumpressurewhichcanbedevelopedis186kPa(1.86bar,27psi).

Todelivertheamountofdrugspecifiedbytheparametersettings,thepump’smicroprocessorcausesthepumpmechanismtodeliver0.05ml(or0.1mlwithaCADD‑Prizm®highvolumeadministrationset)fluid“pulses”timedaccordingtothedesiredrate.Atrateshigherthan3ml/hr,2pulsesinsuccessionwillbegiven.Thus,todeliver20ml/hr,forexample,themicroprocessorsolvestheseequations:

Mechanismactivationsperhr

= 20mlperhr/0.1mlperactivation

= 20/0.1

= 200

Time(seconds)betweenactivations

= 3600secperhr/numberofactivationsperhr

= 3600/200

=18 Rate Volume (ml/hr) Resolution (ml) Cassette or 0‑3 0.050 Admin Set 3.1‑125 0.100

Hi Vol 0‑6 0.100 Admin Set 6.1‑350 0.200

Themicroprocessorusesitstimercircuitstoaccuratelytimethe18seconds(inthisexample)betweenmechanismactivations.Thetimebaseaccuracyisultimatelydeterminedbythe3.6864MHzquartzcrystaloscillator.

Figure7.AsimulatedpumpingmechanisminaCADD‑Prizm®pump.

LockButton

LatchButton

PressurePlateInletValveOutletValve

PumpTubing

CassetteHinge

OcclusionSensor

Expulsor

PumpHousing

CamshaftMotor

15

Air DetectorTheairdetectorisdesignedtodetectairintheoutlettubingfluidpath.Theairdetectorisdetachableifnotneeded.TheCADD‑Prizm®pumpautomaticallydetectsthepresenceoftheairdetectorandwillautomaticallyturnthesensoronwhenpoweredupinLL0.

Whentheoptionalairdetectorisinstalled,theBiomedToolboxfeatureallowstheairdetectortobe“required”or“notrequired.”Whentheairdetectorisnotrequired,itcanbe“turnedon”or“turnedoff”usingtheOptionsmenu.Whentheairdetectorisrequired,theoptionforturningtheairdetectoronoroffwillnotbeavailable.Whentheairdetectoristurnedon,thepumpwilldetectthepresenceofairintheoutlettubingfluidpath.Iftheairdetectorsettingsare“notrequired”and“turnedoff,”itwilldefaultto“turnedon”eachtimethepumppowersupinLockLevel0.

TheairdetectoriscompatiblewithallofthereservoirsandsetsindicatedforusewiththeCADD‑Prizm®pump,andallpumpaccessories.ItispowereddirectlyfromtheCADD‑Prizm®pumpandnoadditionalpowerisrequired.

SpecificationsTheairdetectorwillalarmwhenitsensesasingleairbubblegreaterthan100microliters(0.1milliliters.)

ConstructionTheairdetectorhousingismadeofaspecialhighimpactplasticandhasametalizedfilmcoatingontheinsidesurfacetoreduceinterferencefromelectromagneticfields.Theairdetectoriscomposedofasinglebasecompartmentwithadetachabledoor.Itissealedagainstthepumphousingtoensuretheoverallassemblyiswaterresistant.Theairdetectorismountedtothepumphousingwithtwoscrews,andelectricallyconnectedwithatenpinconnector.

Theory of OperationTheairdetectorconsistsofsensorelectronicsandtwoultrasonictransducerspositionedonoppositesidesofthetubing.Onetransduceractsasanacoustictransmitterandtheotherasanacousticreceiver.Airdetectionoccurswhenairinthefluidpathcausesareductioninthesignalleveltothereceiver.Whenthesignalisinterruptedforapresetlengthoftime,thesensingcircuitrysendsasignaltothemicroprocessorindicatingairinthefluidpath.Tomaximizethereliabilityofthesystemandtoreducefalsealarms,thetransmittedsignalissweptoverafrequencyrange.Thisaccommodatesvaryingresonancefrequenciesofthetransducerandreducessensitivitytotubingtolerancesandothermechanicalvariations.

Upstream Occlusion Sensor

Theory of Operation

Theupstreamocclusionsensorisastraingaugedevicecapableofdetectingpressurechangesinthedisposabletubingset.Thisisaccomplishedbyusingaloadingballorspherelocatedonthebottomofthepump.Thisloadingballcontactsthepumptubingwhenatubingsetisattachedtothepump.Undernormaloperation,thepumptubepushesoutwardandappliesaspecifiedforceonthesensor.Whenanupstreamocclusionispresent,theupstreamtubingcollapsespullingawayfromthesensorreducingtheforceonthesensor.Itisthischangeoftheforcethatindicatesanupstreamocclusion.

16

6 Safety Features and Fault Detection

Hardware Safety FeaturesKeyhardwaresafetyfeaturesincludeawatchdogtimercircuit,motordriverandmotorwatchdogcircuits,cassette‘type’sensorcircuit,latch/locksensorcircuit,andavoltagedetectorcircuit.Eachsafetycircuitperformsauniquefunctiontoinsuretheoverallsafetyofthedevice.(SeeFigure8.)

Watchdog Timer CircuitThemicroprocessormustsendanappropriatesignaltothewatchdogcircuitatleastoncepersecond.Ifthemicroprocessordoesnot,thewatchdogcircuitwilltimeoutandshutdownthepumpcontroller.

Watchdogtimercircuitryisprovidedtomonitorthestatusofthemicroprocessoranddisablethemotorandenabletheaudiblealarmifthemicroprocessorfailstofunctionproperly.Themicroprocessormuststrobethewatchdogcircuitatleastonceeverysecondinordertopreventthewatchdogfromperformingitsresetfunction.Theresetoutputfromthewatchdogcircuitisapulseoutput.Thisactsto“jumpstart”themicroprocessor.Thisuniquefeatureallowsthemicroprocessortotestthewatchdogcircuitoneverypower‑up.Bysettingaflaginmemoryandnotstrobingthewatchdog,themicroprocessorcanforceawatchdogtime‑out.Afterbeingreset,themicroprocessorchecks

thestatusflagtoseeifthiswasatime‑outtest.Ifso,themicroprocessorcontinuesnormalpower‑upactivities.Iftheresetoccurredwhenthemicroprocessorwasnotexpectingit,themicroprocessortrapstheevent,soundstheaudiblealarmanddisplaysanerrormessageontheLCD.

Motor Driver/Motor Watchdog CircuitMotordrivecircuitryiscomposedofaseriesofpowerFETtransistors,passivecomponents,andtwovoltagecomparators.BuiltintothemotordrivecircuitryisanRCtimerwhichtimeshowlongthemotorrunseachtimeitisturnedon.Ifthemotorrunsformorethananaverageof4seconds,thecircuitwilltimeoutanddisablethemotor.Auniquefeatureofthiscircuitisthatcontrollinestoandfromthemicroprocessorcircuitallowthemicroprocessortoperformacompletefunctionaltestofthemotordrivecircuitwithoutrunningthemotor.Themicroprocessorperformsthistestfunctioneveryseveralminutestoassureitscontinuedfunctionality.Aninputfromthewatchdogcircuitpreventsmotoroperationifthewatchdogtimerexpires.

PROGRAM MEMORY

MB

DATA MEMORY

MB

LCD DISPLAY VOLTAGE REFERENCE

MOTOR DRIVER

WATCHDOG

REAL-TIME CLOCK

CPU/IO/ GATE ARRAY

KEYBOARD

MOTOR WATCHDOG

VOLTAGE DETECTOR

SENSORS

AUDIBLE ALARM

Figure8.CADD‑Prizm®pumphardwareblockdiagram.

17

Cassette ‘Type’ Sensor CircuitThecassette‘Type’sensorsystemconsistsofthreepinsprotrudingfromthebuttonofthepumpmechanismthatinterfacetotheattachedadministrationsetandassociatedcircuitry.EachtypeofadministrationsetdesignedtoworkwiththeCADD‑Prizm®pumpcontainsaunique‘code’programmedintothesetvianubsmoldedintotheplastic.Whenasetislatchedtothepump,thenubspressagainstthepinsinthepumpmechanisminapatternuniquetothatsettype.Opticaldetectorsandelectroniccircuitryonthecircuitboardencodethispatternandreporttheinformationtothemicroprocessor.Thisfeatureallowsautomaticrateselectiondependentonthetypeofsetattached.Thissystemalsoactsasasafetyfeaturetodetectadamagedordetachedset.

If,duringoperation,themicroprocessordetectsallpinsextended,thepumpwillenableaudibleandvisualalarmsandstopdelivery.Redundancyinthepatternpreventssinglefaultfailuresfromcausingoverorunderdeliveryoffluid.Additionalcircuitryallowsthesesensorstobeturnedonandoffbythemicroprocessortoconservebatterypower.Additionally,controlofsensorpowerallowsthemicroprocessortotestthesensorinputsinboththepoweredandunpoweredstates,thusallowingdetectionofsensorfaultconditions.Careshouldbetakennottodamagethesesensorpins.

Latch/Lock Sensor CircuitLatchandLocksensorsallowthemicroprocessortodetectthepositionsofthelatchandlockbuttons.Thispreventsattemptedfluiddeliverywhenthesetisnotcorrectlylatchedtothepump.Inaddition,itallowsthemicroprocessortostopfluiddeliveryandenableaudibleandvisualalarmsifthesetisunlatchedduringfluiddelivery.Opposinginfraredtransmittersandreceiversonboththelatchandlockbuttonsallowthemicroprocessortodetecttheiropenandclosedpositions.Additionalcircuitryallowsthesesensorstobeturnedonandoffbythemicroprocessortoconservebatterypower.Additionally,controlofsensorpowerallowsthemicroprocessortotestthesensorinputsinboththepoweredandunpoweredstates,thusallowingdetectionofsensorfaultconditions.

Voltage Detector CircuitLowvoltagedetectionisperformedbypartofthewatchdogcircuitandbythemicroprocessorviasoftware.Threelowvoltagelevelsaredetected.Thefirsttwolevelsaredetectedbysoftwareandthethirdbyhardware.ThefirstleveltobereachedistheLowBatteryWarningthresholdwhichoccurswhenthebatteryvoltagedecaystoanominalvalueof6.8volts.AnAnalogtoDigitalConverter(ADC)builtintothemicroprocessorallowsthemicroprocessor,viasoftware,tomonitorthebatteryvoltage.AttheLowBatteryWarningthreshold,themicroprocessorenablesaperiodicseriesofbeepsanddisplaysalowbatterywarningmessageontheLCD.Asthebatteryvoltagereachesanominalvalueof6.3volts,thesoftwaredisablesdelivery,placesabatterydepletedmessageontheLCD,andenablesaconstanttwo‑toneaudiblealarm.Whenthebatteryvoltagedecaystoanominalvalueof5.6volts,ahardwareresetcircuitistriggeredwhichplacesthemicroprocessorinreset.Thispreventsambiguousmicroprocessoroperationwhenthebatteryvoltagecontinuestodecay.Thehardwareresetcontinuesuntilthebatteryiscompletelydischargedoruntilitisremoved.Oncethepumpcontrollergoesintolowbatteryshutdown,onlyreplacingtheoldbatterywithafreshonewillclearthecondition.

18

Software Safety Features

Hardware-related Software Safety Features

Program Memory Check

Atpowerupandatregularintervalsthereafter,theprogrammemoryistestedbycalculatingaCyclicRedundancyCode(CRC)ontheprogramandthencomparingitwiththeCRCstoredwiththeprogram.IfthestoredandcalculatedCRCsdonotmatch,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

RAM Memory Check

Atpowerup,therandomaccessmemoryischecked.AparticularbitpatterniswrittentoandreadfromeachaddressintheRAM.Ifthereaddataisdifferentfromthewrittendata,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

Motor Circuit Check

Atpowerupandatregularintervalsthereafter,themotorcircuitischeckedtoensurethatnopowerisbeingappliedtothemotorunlessthemotorisactuallyon.Ifthesoftwaredetectspowerbeingappliedtothemotoratanyothertime,itwillsoundacontinuoustwo‑toneaudiblealarmandwillnolongerattempttodelivermedication.Duringeverypumpactivation,thesoftwarecheckstoseewhetherthemotorcompletesoneactivation.Ifthemotorfailstoturn,orfailstocompleteacycle,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

Keyboard Encoder Check

Everytimethesoftwarereceivesdatafromthekeyboardencoder,itischecked.Ifthedataisnotoftheproperform,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.TheDOSEkeyhastwoindependentsignallinestopreventsinglefaultfailures.

Data Handling Software Safety Features

Data Stored in RAM

Beforeuse,dataassociatedwithdeliveryandstoredinRAMistestedbycalculatingaCRConthedataandthencomparingitwiththeCRCstoredwiththedata.IfthestoredandcalculatedCRCsdonotmatch,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

Data Stored in EEPROM

Beforeuse,dataassociatedwithdeliveryandstoredinEEPROMistestedbycalculatingaCRConthedataandthencomparingitwiththeCRCstoredwiththedata.IfthestoredandcalculatedCRCsdonotmatch,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

Data Stored in NOVRAM

Beforeuse,dataassociatedwithdeliveryandstoredinNOVRAMistestedbycalculatingaCRConthedataandthencomparingitwiththeCRCstoredwiththedata.IfthestoredandcalculatedCRCsdonotmatch,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

Data Used in Calculations

Calculationsondatausedinsomewaytocontrolthedeliveryofdrugareperformedredundantly.Thetwocalculatedvaluesarethencompared.Ifthetwovaluesdonotmatch,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

Timer Data Registers

Thedatastoredinthetimercontrolregisterischeckedatregularintervals.Ifthedataisnotcorrect,thesoftwarewillturnonacontinuoustwo‑toneaudiblealarmandstopalldrugdelivery.

19

OverviewIftheCADD‑Prizm®pumpdisplaysanerrorcode,ahardwareorsoftwarefaulthasbeendetectedbythemicroprocessor,andthepumpshouldbereturnedforservicing.

Whenhardwareorsoftwarefaultsaredetectedbythemicroprocessor,pumpoperationstopsandacontinuous,audiblealarmwillbeactivatedaswellastheamberwarningLED.Anerrormessagewillbedisplayed.Onthenextpowerup,theerrorcodewillagainbedisplayedwiththesoftwarelevel(seeillustrationbelow).Iftheerrordetectedwasadatafault,thepumpwillbeinLockLevel2,andallotherprogrammedfunctionswillhavedefaultvalues.(Seethepump’sOperator’s Manualforspecificdefaults.)

7 Hardware and Software Fault Detection

ErrorDetectedE(XXXXX)

Order of Error Code Events1.Thereisacontinuoustwo‑toneaudible

alarm,acontinuousamberindicatorlight,andthedisplaywillread:

NOTE“XXXXX” is a 5-digit code.

2.Tosilencetheerrorcodealarm,removethebattery.

3.Atthenextpower‑up,thelasterrorcode(lec)willbevisibleonthedisplay.ThemicroprocessorwillalsorecordanerrorcodeintheEventLog.Thedescription“ErrorDetected”alongwithfivedigitswillappearintheLCDintheEventLog.ThesefivedigitswillremaininmemoryandwillappearontheEventLogrecorduntil500datawriteshaveoccurredoruntilthemodehasbeenchanged.(See“TestingProcedures”startingonpage23ofthismanualfordetailedinstructionsregardingthepower‑upcheck.)Thus,thereisalwaysarecordofthelastinternalfaultdetectedbythemicroprocessor.

C A D D - P R I Z M 61XX lec XXXXXsn XXXXXXXX 0254-01X 625 XXXXX XXXX-X

Terminal Softwarerevisionlevel

Errorcode Pumpmodelnumber

Serialnumber

20

8 Cleaning and Inspection ProceduresInspection RecommendationSmithsMedicalrecommendsannualfunctionalinspectionontheCADD‑Prizm®pump.Thefollowinginspectionandtestingproceduresshouldbeperformedannuallytoverifyfunctionandaccuracy.

NOTEPersons performing the following tests and procedures should be familiar with the Smiths Medical CADD-Prizm® pump. Please read the Operator’s Manual supplied with the pump before proceeding.

WARNINGCADD® pumps are sealed units. A broken or damaged seal will, therefore, be considered conclusive evidence that the pump has been misused and/or altered, which voids any and all warranties. All service and repair of CADD® pumps must be performed by Smiths Medical or its authorized agents.

Cleaning

CAUTION

• Do not immerse the pump in cleaning fluid or water. Do not allow solution to soak into the pump, accumulate on the keypad, or enter the battery compartment.

• Do not allow solution to enter the data in-out jack or the power jack. Make sure the jack covers are closed before cleaning.

• Do not expose the open air detector port area of the pump or the connector opening on the air detector to foreign material, moisture or cleaning fluids. If an air detector is not installed on the pump, make sure the air detector port cover is securely attached before cleaning.

• Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners.

Useanyofthefollowingsolutionstocleanthepumpandaccessories:• Soapsolution• Benzalkoniumchlorideconcentrate(0.13%)• Glutaralconcentrate,USP(2%)• 20percentsolutionofhouseholdbleach

(oneparthouseholdbleachtofourpartswater–1.2%SodiumHypoChloriteor12,000ppm)

• Alcohol,USP(93%)• IsopropylAlcohol,USP(99%)• PDI–SuperSani‑Cloth®

• MadaMedical–MadaCide

1. Dampenasoft,lint‑freeclothwithcleaningsolution.Applythesolutiontoexteriorsurfaceofthepumporaccessory.Donotallowthesolutiontosoakintothepumporaccessory.

2. Wipetheentiresurfacedrywithanothersoft,lint‑freecloth.Allowthepumptodrycompletelybeforeuse.

Visual Inspection• Visuallyinspectthepumpforanydamageto

theLCD,occlusionsensorseals,valvesandexpulsor,reservoirhingearea,latch,lock,cassettesensors(3),keyboard,indicatorlights,powerjack,datain/outjack,airdetectorportcoverorairdetector,andhousing.Ifanydamageisnoted,thepumpshouldbereturnedforservice.

• Checkthebatterydoorforproperoperation.Itshouldnotbebrokenordamaged.Thematingtabsonthepumphousingshouldnotbebrokenordamaged.

• Examinethebatterycompartmentfordamage.Ifthebatterycontactsappearcorroded,cleanthemwithacottonswabandisopropylalcohol.Ifthebatterycontactsappeartobebentorpushedin,straighteningmaybepossiblewithasmallscrewdriverorothersuitabletool.Caremustbetakensoasnottodamagethepumphousingortoincurfurtherdamagetothecontacts.

21

Mechanical Inspection• Presseachkeyonthekeyboard.Eachkey

shouldhaveadistinctivedomefeeling.Thekeysshouldnotfeelflat.

• Attachthebatterydoor.Thebatterydoorshouldfitsnuglyinplacewhenitisclosedonthepump.

• Attacheithera50‑or100‑mlCADD™medicationcassettereservoiroraCADD®administrationsettothepump.Checkforsmoothoperationandadefinite“feel”whenthelatchpullsthereservoiroradministrationsetfirmlyagainstthebottomofthepump.Themarkonthelatchshouldbealignedwiththesoliddot.

• Lockthedevicebyinsertingakeyintothelockandturncounterclockwiseuntilthemarklinesupwiththesoliddot.

• Gentlytwistandpullonthecassettetomakesureitisfirmlyattached.

NOTEIn the PCA delivery mode, the cassette must be locked in order to start the pump.

22

9 Testing Procedures

ReservoirLatched TheCADD™medicationcassettereservoirhasbeenlatchedontothepump.

AdminsetLatched TheCADD®administrationsethasbeenlatchedontothepump.

HighVolume TheCADD‑Prizm®

AdminSetLatched highvolumeadministrationsethasbeenlatchedontothepump.

Table13.

(excludingPCAdeliverymode)

C A D D - P R I Z M 61XX lec XXXXXsn XXXXXXXX 0254-01X 625 XXXXX XXXX-X

Terminal Softwarerevisionlevel

Errorcode Pumpmodelnumber

Serialnumber

Functional TestingThePower‑upCheck,Latch/LockCheckandCassetteSensorCheckusingaCADD™medicationcassettereservoirorCADD®administrationsetcanbeperformedwiththepumpinanyofthefourdeliverymodes.TheCassetteSensorCheckusingtheCADD‑Prizm®highvolumeadministrationsetcanbeperformedinanydeliverymodeexceptthePCAdeliverymode.

Power-up Check• Insertabatteryinthepumpandobservethe

LCDduringpowerup.

Thenumbervaluesmayvarydependingonthecurrentmodeandsoftwarerevision.

• If“lecXXXXX”(lasterrorcodewith5digitnumber)appearsonthedisplaypriortothepumpreviewingthecurrentprogramsettings,thepumphasexperiencedanelectricalormechanicalfaultandshouldbereturnedforservice.Ifnoerrormessageisimmediatelyshown,thepumphaspoweredupnormally.Thepumpshouldsequentiallydisplayalloftheprogrammedvalues.Thewords“SelfTestComplete”shouldappear,thenthetext“PowerUpSuccessful”withsixaudiblebeeps.ContinuewiththeLatch/Lockcheck.

Latch/Lock Check• Attacha50‑or100‑mlCADD™medication

cassettereservoiroraCADD®administrationsettothepump.Themarkonthelatchshouldbealignedwiththesoliddot.Thedisplayshouldshowthatthereservoiroradministrationsetislatched.SeeTable13.

• Lockthedevicebyinsertingakeyintothelockandturningcounterclockwiseuntilthemarklinesupwiththesoliddot.Thedisplayshouldshow“CassetteLocked.”

• Unlockthedevicebyinsertingakeyintothelockandturningclockwiseuntilthemarklinesupwiththeopendot.Thedisplayshouldshow“CassetteUnlocked.”

• Unlatchthereservoirbyinsertingacoinintothelatchslotandturningclockwiseuntilthemarklinesupwiththeopendot.Thedisplayshouldshow“CassetteUnlatched/CloseClamptoPreventFreeFlow.”

Cassette Sensor Check• Attacha50‑or100‑mlCADD™medication

cassettereservoirtothepump.Latchthecassettetothepump.Thedisplayshouldshow“Reservoirlatched.”NOTE:Themessagedisplayeddependsonthetypeofreservoiroradministrationsetattached.SeeTable13.


• Unlockthecassette.Thedisplayshouldshow“CassetteUnlocked.”Unlatchthecassette.Thedisplayshouldshow“CassetteUnlatched/CloseClampToPreventFreeFlow.”

• Removethe50‑or100‑mlreservoirandattachaCADD®administrationsettothepump.Latchthecassettetothepump.Thedisplayshouldshow“AdminSetLatched.”


23


• RemovetheadministrationsetandattachaCADD‑Prizm®highvolumeadministrationsettothepump(excludesPCAdeliverymode).Latchthecassettetothepump.Thedisplayshouldshow“HighVolumeAdminSetLatched.”



NOTEThe basic electrical and mechanical functions of the CADD-Prizm® pump are the same for each of the four delivery modes. Regardless of the delivery mode, the delivery accuracy and timing circuitry remains unchanged. Although functional testing of the CADD-Prizm® pump can be performed in any mode, the remaining tests are intended to be performed in the PCA delivery mode. Additional tests may be performed with the pump in a different delivery mode if desired.

Thefollowingthreechecks(LCD,motorandgeartrain,andReservoirVolumeisZeroalarm)shouldbeperformedinthesequenceshown.

LCD Check• Removeandreinsertthebattery.Afterafew

seconds,theLCDwilldisplayalloffpixels(dots)followedbyallonpixels.ExaminetheLCDformissingdarkorlightpixels.

• Programthepumptothefollowingparameters:

ReservoirVolume 2.0mlUnits MilligramsConcentration 1.0mg/mlContinuousRate 30.0mg/hrDemandDose 0.0mgMilligramsGiven 0.0mg(pressthe ENTERkeytoclear)

• PresstheNEXTkeyuntilreservoirvolumeisdisplayedontheLCD.PresstheYorNkeyuntil2.0mlisdisplayed.ThenpresstheENTERkey.SelectMilligramsforunitsandpresstheENTERkey.SelecttheConcentrationof1.0mgandpresstheENTERkey.SelecttheContinuousRateof30.0mg/hr,thenpresstheENTERkey.SelecttheDemandDoseof0.0mg,thenpresstheENTERkey.CleartheMilligramsGivenregisterbypressingtheENTERkey.

Motor and Gear Train Check• Attacheithera50‑or100‑mlCADD™

medicationcassettereservoirorCADD®administrationsettothepump.Latchandlockthecassette.

• Select“Prime”fromtheOptionsmenubypressingtheOPTIONSkey,thentheENTERkey.NowpressandcontinuetoholdtheYkey.Thepumpshouldbegintoprime.Whileprimingthepump,listentothemotorforexcessivenoiseorgrindingsounds.Countthenumberofpumpactivations.Thepumpshouldprimetendoubleactivationsandthenstop.Thedisplayshouldshow“ContinuePriming?PressYorN.”PresstheNkey.ThenpresstheNEXTkeytwiceuntiltheReservoirVolumescreenappears.Thereservoirvolumeshouldshow1.0ml.

Reservoir Volume is Zero Alarm Check• PresstheOPTIONSkeyandselectthePrime

functionbypressingtheENTERkey.RepeatprimingbypressingandholdingtheYkey.Thepumpshouldprimetendoubleactivationsandthenstop.Thepumpwillalarmanddisplay“ReservoirVolumeisZero.”PresstheNEXTkey.

• Reprogramthereservoirvolumeto1.0ml.PresstheNEXTkeyuntilReservoirVolumeisdisplayedontheLCD.PresstheYorNkeyuntil1.0mlisdisplayed.ThenpresstheENTERkey.

NOTEThe remaining testing procedures should be performed using a 50- or 100-ml CADD™ medication cassette reservoir containing fluid and a primed extension set with anti-siphon valve or a primed CADD® administration set with anti-siphon valve.

24

Starting/Stopping the Pump• ChecktheSTOP/STARTkeybypressingit.

“StartthePump?”shouldbedisplayed.PresstheYkey.Thedisplayshouldshow“StartingPump”followedbyareviewoftheprogrammedparameters.Themainscreenshouldappearwith“RUNNING”inthedisplay,andthegreenLEDindicatorlightshouldblinkevery3seconds.

• Tostopthedevice,presstheSTOP/STARTkey.Whenthemessage“StopthePump?”appears,pressY.STOPPEDappearsinthedisplayandtheamberLEDindicatorlightblinks.

Activation Timing Check• Checktheactivationtimingbyprogramming

thepumpwiththefollowingvalues:

ReservoirVolume 1.0mlUnits MilligramsConcentration 1.0mg/mlContinuousRate 30.0mg/hrDemandDose 0.0mgMilligramsGiven 0.0mg(pressthe ENTERkeytoclear)

• PresstheSTOP/STARTkey.PresstheYkey.“StartingPump”shouldappearonthedisplay.Thepumpshouldsequentiallydisplayalloftheprogrammedvalues.Startatimeratthefirstmotoractivation.

• Counttheactivations.Oneactivationshouldoccureverytwelveseconds.Approximatelyoneminutefiftyseconds(1:50)andtenactivationslater,theRESVOLalarmshouldoccur.Thedisplayshouldshow“ReservoirVolumeisZero”withaMilligramsGivenof1.0mg.

DOSE Key Check• ChecktheDOSEkeyoperationby

programmingthepumpwiththefollowingvalues:ReservoirVolume 10.0mlUnits MilligramsConcentration 1.0mg/mlContinuousRate 0.0mg/hrDemandDose 1.0mgDemandDoseLockout 0hrs5minMaxDosesPerHour 12DoseCounters 0/0(Pressthe ENTERkeyto clear)MilligramsGiven 0.0mg(Pressthe ENTERkeytoclear)

• PresstheSTOP/STARTkey.PresstheYkey.Thepumpshouldsequentiallydisplayalloftheprogrammedvalues.

• AfterRUNNINGappearsonthedisplay,presstheDOSEkeyandnotethetime.Thepumpshouldbeeptwiceandbegintodeliver.Countthenumberofpumpactivations.Thepumpshouldmaketendoubleactivations.Aftertendoubleactivations,thedisplayshouldshowareservoirvolumeof9.0ml.PresstheDOSEkeytwomoretimeswithinthenext5minutes.Thepumpshouldnotdeliverandthemessage“DoseNotDeliveredDoseLockedOut”shouldbedisplayed.

Remote Dose Cord Check (if applicable)• Wait5minutesafterthedosegivenabove;

then,insteadofpressingtheDOSEkey,pressthebuttonontheRemoteDosecord.Thepumpshouldmaketendoubleactivations.Aftertendoubleactivations,thedisplayshouldshowareservoirvolumeof8.0ml.PresstheDOSEkeytwomoretimeswithinthenext5minutes.Thepumpshouldnotdeliverandthemessage“DoseNotDeliveredDoseLockedOut”shouldbedisplayed.

Doses Given and Doses Attempted Check• StopthepumpbypressingtheSTOP/START

key,thentheYkey.UsetheNEXTkeytoadvancetotheDoseCountersscreen.Thedisplayshouldshow2/6,iftheDOSEkeyandRemoteDosecordweretested.IfonlytheDOSEkeywastested,thedisplaywillshow1/3.(Iftheabovestepshavenotbeenfollowedexactly,differentvaluesmayappear.)

• PresstheENTERkey.Thedisplayshouldnowshow0/0.

MG GIVEN Mode Check• PresstheNEXTkeytoadvancetothe

MilligramsGivenscreen.Thedisplayshouldnowshow2.0mg,iftheDOSEkeyandRemoteDosecordweretested.IfonlytheDOSEkeywastested,thedisplaywillshow1.0.(Iftheabovestepshavenotbeenfollowedexactly,differentvaluesmayappear.)

• PresstheENTERkey.Thedisplayshouldnowshow0.0mg.

25

Air Detector Test (if applicable)

Thistestwillverifythefunctionoftheoptionalairdetector.Toperformthistest,theCADD‑Prizm®pumpmusthaveanairdetectorinstalledandtheairdetectormustbeturnedon.ThepreviousprogramfromtheDOSEkeycheck(page26)canbeusedtoperformthistest.• AttachanemptyCADD™medication

cassettereservoirorCADD®administrationsettothepump.

• Latchandlockthesettothepump.• Opentheairdetectordoorandthreadthe

tubingthroughthegroove.• Closethedoormakingsurethetubingdoes

notgetpinchedorkinked.• Startthepump.• Thepumpshouldrespondwithacontinuous

two‑tonealarmandthedisplayshouldread: Airinlinedetected

PumpwillnotrunNexttosilence

• PressNEXTtosilencethealarm,andremovetheCADD™medicationcassettereservoirorCADD®administrationset.

• NowattachaCADD™medicationcassettereservoircontainingfluidandaprimedextensionsetwithanti‑siphonvalve,oraprimedCADD®administrationsetwithanti‑siphonvalvetothepump.Makecertainthereisnoairinthefluidpath.

• Latchandlockthesettothepump.• Opentheairdetectordoorandthreadthe

tubingthroughthegroove.• Closethedoormakingsurethetubingdoes

notgetpunchedorkinked.• Startthepump.• Deliverademanddose.(NOTE:fiveminutes

musthavepassedsincethedeliveryofthelastdemanddose.)

• Thepumpshoulddeliverthedosewithoutanairdetectionalarm.

Occlusion Accuracy Tests

ThismanualprovidestwotestingoptionsfortheOcclusionPressureRangeTestandtheAccuracyTest.Onlyoneoptionneedstobeperformed.ItisnotnecessarytoperformbothOption1andOption2.

Downstream Occlusion Pressure Range Test (Option 1)

Description

Pressureisgeneratedbyactivatingthepumpingmechanismwithanattachedfilled,clampedCADD™medicationcassettereservoir.ThepumpisstartedandaDemandDoseisgivenuntilthehighpressurealarmsounds.

Equipment needed

50‑or100‑mlCADD™medicationcassettereservoircontainingwater

Procedure

1. Insertabatteryandwaitforthepumptopowerup.

2. AttachaCADD™medicationcassettereservoircontainingwatertothepump.Latchandlockthecassette.

3. PrimetheCADD™medicationcassettereservoirtubing.Thetubingshouldbefilledwithfluidtotheendoftheluerlockconnector.Thesystemmustbefreefromairbubblesforthistest.

4. ClosetheslideclamponthedistalendofthetubingnearthefemalelueroftheCADD™medicationcassettereservoir.

5. Programthepumptothefollowingparameters:

ReservoirVolume 10.0mlUnits MilligramsConcentration 1.0mg/mlContinuousRate 0.0mg/hrDemandDose 1.0mgDemandDoseLockout0hrs5minMaxDosesPerHour 12DoseCounters0/0 (PresstheENTER keytoclear)MilligramsGiven 0.0mg(Pressthe ENTERkeytoclear)

6. Startthepump.Whenthepumpisrunning,activateaDemandDose,notingwhenthehighpressurealarmisactivated.

7. Thepumpshouldalarmwhenthepumpdeliversbetween1and2activations.

CAUTIONAt the completion of the test, the pressure must be reduced to zero before detaching the cassette from the pump; otherwise, the cassette may rupture. Safety glasses should be worn while conducting or observing this test.

26

Figure9.Occlusiontestset‑up.

Pressure GaugeRegulator

30PSI

6/5/96 D. Zurn, Occlusion Set-up Prizm 6/96

Downstream Occlusion Pressure Range Test (Option 2)

Description

AnadjustablemeteredpressuresourceisconnectedtotheCADD™medicationcassettereservoirtubing.Thepressureisslowlyincreaseduntilthehighpressurealarmsounds.

Equipment needed• Pressuregauge,30psi±1psi• Pressurevessel,partiallyfilledwithwater• Pressureregulator,30psi• 50or100mlCADD™medicationcassette

reservoircontainingwater

Procedure

1. Insertabatteryandwaitforthepumptopowerup.

2. AttachaCADD™medicationcassettereservoirtothepump.Latchandlockthecassette.

NOTEThe pressure from the source must be zero when the cassette is attached.

3. AssembletheapparatusasshowninFigure9.

4. ConnecttheCADD™medicationcassettereservoiroutlettubetothemeteredpressuresource.

NOTE Do not use a CADD® extension set with anti-siphon valve.

5. Startthepumpandrunat30ml/hr.

6. Slowlyincreasethebackpressure,noting whenthehighpressurealarmisactivated.

NOTE The pressure may be increased rapidly to 8 psi, after which the pressure should be increased at 3 psi/min or less until the alarm sounds.

7. Thehighpressurealarmshouldsoundbetween9and27psi(18±9psi).

Upstream Occlusion Sensor Test (Model 6101 pumps only)

Description

Thetubingbetweenthefluidreservoirandthepumpisoccludedwhilethepumpisrunninguntiltheocclusionalarmsounds.

Equipment needed• CADD®administrationsetwith

anti‑siphonvalve• Tubingclamp(slideclamporhemostat)

Procedure

1. SpikeanappropriatestandardI.V.bag.

2. Primetheentirefluidpath.

3. Programthepumptodeliveracontinuousrateof20ml/hr.

4. Startthepump.

5. Clampthetubinghalfwaybetweenthefluidreservoirandthepump.

6. Thepumpshouldalarmwithinthreeactivationsafterclampingthetubing.

NOTE Make sure the upstream occlusion sensor is turned on in the Biomed Toolbox.

Accuracy TestingAccuracytestingmaybeperformedinanydeliverymode.ThismanualshowsanexampleofdeliveryaccuracytestingwiththepumpinthePCAdeliverymode.

Gravimetric Accuracy Testing (Option 1)

Description

ACADD™medicationcassettereservoirispartiallyfilledwithwaterandweighed.Thereservoiristhenattachedtothepumpandthepumpissettodeliveracertainamountofwater.Thereservoiristhenremovedandweighedagain.Theamountofwaterdeliverediscomparedtotheamountthatthepumpshouldhavedelivered.

27

Nominalsystemaccuracyisgiveninthetechnicalspecificationssectionforthepump.Thatis,underthetestconditionsdescribedbelow,theaccuracyofthepumpandreservoirwillbenominalwitha90%confidencelevel.Thenominaltestconditionsareasfollows:degassedwaterat25±5°Cwithoutbackpressure.

Equipment needed• 50‑or100‑mlCADD™medication

cassettereservoir• 50‑or60‑mlsyringe• CADD®extensionsetwithanti‑siphonvalve• Abalanceaccurateto0.1g• 40mlofroomtemperaturewater

Procedure

1. Fillthe50‑or60‑mlsyringewith40mlofwater.TransferthewaterintoaCADD™medicationcassettereservoir.

2. RemoveanyairfromtheCADD™medicationcassettereservoirbyaspiratingtheairwiththesyringe.AttachtheCADD®extensionsetwithanti‑siphonvalve.Primethetubingsoitisfilledwithfluidtotheendoftheextensionsetluerlockconnector.

3. Securetheclampasclosetotheextensionsetluerlockconnectoraspossible.Thisshouldassureaminimumwaterlossfromthetubingwhenthesyringeisremoved.

4. Weightheentirereservoir/extensionsetassemblyandrecordtheweight.Thisisthepre‑deliveryweight.(ThisweightincludestheemptyCADD™medicationcassettereservoir,extensionset,andweightofthewater.)

5. AttachtheCADD™medicationcassettereservoirtothepump.Programthereservoirvolumeto20ml.NowpresstheENTERkey.Thisvalueistheintendeddeliveryvolume.(Onemlofwaterat20°Cweighs1gram.)Opentheclamp.

6. WiththepumpinLockLevel0,programacontinuousrateof0ml/hrandadoseof1.0ml(butdonotdeliveraDemandDose).Startthepumpanddeliveraclinicianbolusof20ml.

7. Again,securetheclampascloseaspossibletotheendoftheextensionsetluerlockconnector.RemovetheCADD™medicationcassettereservoirfromthepumpandweightheentirereservoir/extensionsetassembly.Thisisthepostdeliveryweight.

8. Calculatethedifferenceinweightbetweenthepredeliveryweightandthepostdeliveryweight.Thisistheweightoftheamountdelivered.

9. Findthedifferencebetweenthevolumeoftheamountdeliveredandtheintendeddeliveryvolume.Thisistheinaccuracyvolume.

10.Dividetheinaccuracyvolumebytheintendeddeliveryvolumeandmultiplyby100.Thisistheaccuracyerrorpercentage(SeeTable14).

11.Iftheaccuracyerrorpercentageisgreaterthan±6%,repeatthetestwithanewreservoir.Ifthepumpfailsasecondtime,callSmithsMedical’sCustomerServiceDepartment.

Table14.Gravimetricpercentagecalculation

Pre- Post Weight of Intended Inaccuracy Accuracy Accuracy Delivery Delivery Amount Delivery Volume Error Error Percentage Weight Weight Delivered Volume61.1g 41.6g 19.5g=19.5ml 20ml ‑0.5ml ‑0.5ml÷20.0ml= ‑0.025x100=‑2.5% ‑0.025

28

EXAMPLE

PredeliveryWeight 61.1gPostdeliveryWeight ‑41.6gWeightofAmountDelivered 19.5 g = 19.5 ml

VolumeofAmountDelivered 19.5mlIntendedDeliveryVolume ‑20.0mlInaccuracyVolume – 0.5 ml

InaccuracyVolume –0.5mlIntendedDeliveryVolume ÷20.0mlAccuracyError -0.025 ml

AccuracyError ‑0.025 x100.00

AccuracyErrorPercentage –2.5%

Volumetric Accuracy Testing (Option 2)

Description

Apredeterminedamountofwaterisdeliveredintoacollectiondevicesuchasaburetteorgraduatedcylinder.Theamountofwaterdeliverediscomparedtotheamountthatthepumpshouldhavedelivered.

Nominalsystemaccuracyisgiveninthetechnicalspecificationssectionforthepump.Thatis,underthetestconditionsdescribedbelow,theaccuracyofthepumpandreservoirwillbenominalwitha90%confidencelevel.Thenominaltestconditionsareasfollows:degassedwaterat25±5°Cwithoutbackpressure.

Equipment needed• 50‑or100‑mlCADD™medication

cassettereservoir• 50‑or60‑mlsyringe• CADD®extensionsetwithanti‑siphonvalve• Afluidcollectiondevicesuchasaburetteor

aclassA25mlcapacitygraduatedcylinder• 40mlofroomtemperaturewater

Procedure1. Fillthe50‑or60‑mlsyringewith40mlof

water.TransferthewaterintoaCADD™medicationcassettereservoir.

2. RemoveanyairfromtheCADD™medicationcassettereservoirbyaspiratingtheairwiththesyringe.AttachtheCADD®extensionsetwithanti‑siphonvalve.Primethetubingsoitisfilledwithfluidtotheendoftheextensionsetluerlockconnector.

3. Attachtheendoftheextensionsettothefluidcollectiondevice.

4. AttachtheCADD™medicationcassettereservoirtothepump.Programthereservoirvolumeto20ml.Thisistheintendeddeliveryvolume.Openallclamps.

5. Programacontinuousrateof0.0ml/hrandaDemandDoseof1.0ml(butdonotdeliveraDemandDose).Startthepumpanddeliveraclinicianbolusof20ml.

6. Whendeliveryiscomplete,recordthevolumeoffluiddelivered.Thisistheactualdelivery.

7. Findthedifferencebetweenthevolumeoftheamountdeliveredandtheintendeddeliveryvolume.Thisistheinaccuracyvolume.

8. Dividetheinaccuracyvolumebytheintendeddeliveryvolumeandmultiplyby100.Thisistheaccuracyerrorpercentage.(SeeTable15.)

9. Iftheaccuracyerrorpercentageisgreaterthan±6%,repeatthetestwithanewreservoir.Ifthepumpfailsasecondtime,callSmithsMedical’sCustomerServiceDepartment.

Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Percentage Volume Volume 20ml 19.5ml ‑0.5ml ‑0.5/20.0ml=‑0.025 ‑0.025x100=±2.5%

Table15.Volumetricpercentagecalculation

29

CADD-Prizm® Pump Cleaning and Functional Testing ChecklistThefollowingchecklistisprovidedasaguideonlytoassistinestablishingdocumentationofcleaningandfunctionaltestingfortheCADD‑Prizm®pump.Ifserviceisprovided,filloutthissheetandreturnitwiththedevice.

Serial#_______________ ReferenceNumber_______________________ Date_______________________

(RefertotheTechnicalManualprocedures.)

I. CleaningCompleted M Yes M No

II. VisualInspectionM LCD M Lock M DataIn/OutJackM OcclusionSensorSeals M CassetteSensors(3) M AirDetectororPortCoverM ValvesandExpulsors M Keyboard M PumpHousingM ReservoirHingeArea M IndicatorLight M BatteryDoorM Latch M PowerJack M BatteryCompartment

III. MechanicalInspectionM Keyboard M CassetteLatchM BatteryDoor M CassetteLock

IV. FunctionalInspectionM Power‑up M RESVOLAlarm M DoseGiven/AttemptedM Latch/Lock M Stop/Start M MGGivenM CassetteSensor M ActivationTiming M AirDetectorM LCD M DoseKey M PrinterTestsM Motor/GearTrain M RemoteDoseCord

V. OcclusionTests(Onlyneedtoperform1or2;notboth)DownstreamOption1:ActivationsBeforeAlarm___________ DownstreamOption2:HighPressureAlarmAt____________ psi

UpstreamOcclusionSensorTestPass________Fail __________

VI. AccuracyTesting(Onlyneedtoperform1or2;notboth)VolumetricAccuaracyTest

Intended Actual Inaccuracy Accuracy Accuracy Delivery Delivery Volume Error Error Volume Volume Percentage

ml ml ml %

GravimetricAccuracyTest

Pre‑Delivery Post‑Delivery Amount Intended Inaccuracy Accuracy Accuracy Weights Weight Delivered Delivery Volume Error Error Volume

g g ml ml ml %

EC Authorized RepresentativeSmiths Medical International Ltd.TN254BF,UKPhone+44(0)1233722100

Smiths Medical ASD, Inc.St.Paul,MN55112,USAPhone:1‑214‑618‑0218Toll‑FreeUSA:1‑800‑258‑5361

THEDETAILSGIVENINTHISLEAFLETARECORRECTATTHETIMEOFGOINGTOPRESS.THECOMPANYRESERVESTHERIGHTTOIMPROVETHEEQUIPMENTSHOWN.

CADD,CADD‑Prizm,theCADDMedicatonCassetteReservoirandtheSmithsMedicalandCADDdesignmarksaretrademarksofSmithsMedical.Thesymbol®indicatesthetrademarkisregisteredintheU.S.PatentandTrademarkOfficeandcertainothercountries.©2010SmithsMedical.Allrightsreserved.11/10IN19824

Product(s)describedmaynotbelicensedoravailableforsaleinCanadaorothercountriesoutsideoftheUnitedStates.

Smiths Medical Canada Ltd.Markham,Ontario,Canada,L3R4Y8Phone:905‑477‑2000Toll‑Free:1‑800‑387‑4346

www.smiths‑medical.comSmiths Medical is part of the global technology business Smiths Group plc.

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