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
Given0to99999.9in0.1unitincrements
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
Given0to99999.9in0.1unitincrements
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.
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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.
Volume Period TaperUp TaperDown KVO Life Volume
2000 10:00hr 1:00hr 1:00hr 5ml/hr 32hr 6333ml 3000 10:00hr 1:00hr 1:00hr 5ml/hr 19hr 5833ml
Table10.9‑voltLithium‑typebatteriesusedwiththeCADD‑Prizm®pump.
Volume Period TaperUp TaperDown KVO Life Volume
2000 10:00hr 1:00hr 1:00hr 5ml/hr 64hr 12777ml 3000 10:00hr 1:00hr 1:00hr 5ml/hr 45hr 13498ml
Table11.EPSSystemusedwiththeCADD‑Prizm®pump.
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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.
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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.
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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
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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.
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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.
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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.
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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
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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.
• Lockthedevicebyinsertingakeyintothelockandturningcounterclockwiseuntilthemarklinesupwiththesoliddot.Thedisplayshouldshow“CassetteLocked.”
• Unlockthecassette.Thedisplayshouldshow“CassetteUnlocked.”Unlatchthecassette.Thedisplayshouldshow“CassetteUnlatched/CloseClampToPreventFreeFlow.”
• Removethe50‑or100‑mlreservoirandattachaCADD®administrationsettothepump.Latchthecassettetothepump.Thedisplayshouldshow“AdminSetLatched.”
• Lockthedevicebyinsertingakeyintothelockandturningcounterclockwiseuntilthemarklinesupwiththesoliddot.Thedisplayshouldshow“CassetteLocked.”
23
• Unlockthecassette.Thedisplayshouldshow“CassetteUnlocked.”Unlatchthecassette.Thedisplayshouldshow“CassetteUnlatched/CloseClampToPreventFreeFlow.”
• RemovetheadministrationsetandattachaCADD‑Prizm®highvolumeadministrationsettothepump(excludesPCAdeliverymode).Latchthecassettetothepump.Thedisplayshouldshow“HighVolumeAdminSetLatched.”
• Lockthedevicebyinsertingakeyintothelockandturningcounterclockwiseuntilthemarklinesupwiththesoliddot.Thedisplayshouldshow“CassetteLocked.”
• Unlockthecassette.Thedisplayshouldshow“CassetteUnlocked.”Unlatchthecassette.Thedisplayshouldshow“CassetteUnlatched/CloseClampToPreventFreeFlow.”
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
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CADD,CADD‑Prizm,theCADDMedicatonCassetteReservoirandtheSmithsMedicalandCADDdesignmarksaretrademarksofSmithsMedical.Thesymbol®indicatesthetrademarkisregisteredintheU.S.PatentandTrademarkOfficeandcertainothercountries.©2010SmithsMedical.Allrightsreserved.11/10IN19824
Product(s)describedmaynotbelicensedoravailableforsaleinCanadaorothercountriesoutsideoftheUnitedStates.
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www.smiths‑medical.comSmiths Medical is part of the global technology business Smiths Group plc.