Medfusion Syringe Infusion Pump Model 4000 Operator’s Manual · • Before using any Medfusion®...

Medfusion® Syringe Infusion PumpModel 4000

Operator’s ManualSoftware Version V1.1

This manual and its contents are valid for use with software version V1.1

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Medfusion® Model 4000 pump Operator’s Manual

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Technical AssistanceThe issue date of this manual is included on the back cover. If your manual is a year or more old, contact Smiths Medical to see if a newer manual is available.If you have comments or questions concerning the operation of the Medfusion® Syringe Infusion Pump Model 4000 (Medfusion® Model 4000 pump), please call the appropriate number given below. When call-ing, please specify your pump’s software version. This information is located on the start-up screen.Our staff at Smiths Medical in the USA is available to help clinicians 24 hours a day with the programming and operation of the Medfusion® Model 4000 pump.Smiths Medical ASD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 USA1 800.258.5361 (USA), +1 214.618.0218 www.smiths-medical.comA printed copy of this manual is available upon request.


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Table of ContentsImportant Safety Information 1Warnings ................................................................................... 1Cautions .................................................................................... 4Symbols ..................................................................................... 5Introduction 6Indications for use ................................................................... 6Contraindications .................................................................... 7About the pump 8Features and Controls ............................................................. 8

Keypad closeup .................................................................. 9Network Connections 11

Ethernet State ................................................................... 11Wireless State .................................................................... 11Connected to Toolbox ..................................................... 11Network Configuration ................................................... 11

Attaching the Pump to the Network ................................... 11Network status ................................................................. 11

Pump Customization and General Programming 12

Custom Configuration .......................................................... 12General Programming .......................................................... 14Exceeding limits..................................................................... 14How pump settings and limits are prioritized ................... 14User defined pump Configurations .................................... 15

What are Configurations? ............................................... 15When are Drug Programs used? .................................... 15Who can use these Drug Programs? ............................. 15Types of programmable Library Categories ................. 15

Using a Custom Configuration ............................................ 16Using Quick Libraries ........................................................... 17PharmGuard™ Safety Software: Dose Protocol

Protection .................................................................... 19Soft limits .......................................................................... 19Hard limits ........................................................................ 19

Adjusted limits in reverse ........................................... 20Overridden limits in reverse ...................................... 20Invalid infusion parameter combination ................. 20

PharmGuard™ Supported Syringes (PSS) Series 2 ............ 21Navigating the pump menus ................................................ 22

The Workflow Process ..................................................... 22Guidelines for enhanced pump performance 24Always use the smallest syringe for volume of fluid

being delivered ........................................................... 24Bolus Volume ......................................................................... 25Use appropriate internal diameter tubing .......................... 25Programming an Infusion 26Turn the pump on ................................................................. 26

Turning the pump off ...................................................... 27Selecting a Delivery Mode and Programming an

infusion ....................................................................... 28General Infusion Programming Procedure ................. 29

Selecting an Infusion ............................................................. 30Select a Profile (Custom Configuration) ...................... 31

Select a Category ......................................................... 32Select a Drug Program ............................................... 32

Select a Delivery Mode (Medfusion™ Standard Configuration) ............................................................. 33

Loading a syringe and syringe model setup ....................... 34Unloading the syringe ................................................ 38

Programming Infusions........................................................ 39Continuous mode: mL/hr .............................................. 39Dose / Min and Dose / Hr .............................................. 40Dose / Day ........................................................................ 42Dose / Time ...................................................................... 44Body weight/surface area infusion deliveries .............. 46Volume / weight infusions .............................................. 48Dose/kg/time (dose/m2/time) ........................................ 50Volume / weight / time .................................................... 52Volume / time ................................................................... 54Intermittent volume / time ............................................ 55Recall last settings ............................................................ 57

Priming the system ................................................................ 59Options 61Bolus dosing ........................................................................... 62

Bolus programming......................................................... 62Bolus delivery ................................................................... 64

Continuing an interrupted bolus dose ..................... 65Bolus dose rate reduction ............................................... 66

Loading doses ........................................................................ 67Set up loading dose .......................................................... 67Delivering a loading dose ............................................... 69

Continuing an interrupted loading dose ................. 70Loading dose rate reduction ........................................... 71

Volume limit .......................................................................... 72Setting volume limit ....................................................... 72

Keep Vein Open (KVO) rate ................................................ 74Programming KVO rate ................................................. 74

Standby ................................................................................... 76Programming standby..................................................... 76

Delayed start .......................................................................... 78Programming delayed start ............................................ 78

Periodic callback alarm ........................................................ 79Programming periodic callback alarm ......................... 79

Override and toggle features ................................................ 81Change to Dose / Change to Volume ........................... 81Override occlusion limit ................................................ 82Override alarm loudness ................................................ 83Disable/enable FlowSentry™ ........................................... 84Disable/enable near empty alarm tone ......................... 84Disable/enable vol empty alarm tone ............................ 85

Infusion Delivery 86Starting & stopping infusion delivery ................................. 86

Start delivery from pause ................................................ 86Starting delivery from standby or delayed start ........... 87

Stopping delivery......................................................... 87Continuing interrupted delivery ............................... 87

Flush feature ........................................................................... 88Volume only ..................................................................... 88

Continuing an interrupted flush infusion................ 89Volume and time .............................................................. 90


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Time to occlusion .................................................................. 92Occlusion trend graph during delivery .............................. 92

FlowSentry™ (rapid occlusion detection) ..................... 92Post occlusion bolus reduction ..................................... 93

Making changes during delivery ......................................... 94Changing delivery rate .................................................... 94

Changing rate during delivery .................................. 94Changing the rate when paused ................................ 95

Total volume, program volume / dose delivered ............... 96Displaying “Program Volume Delivered” (PVD) /

“Program Dose Delivered” (PDD) ........................... 96Clearing total volume, program volume, or

program dose delivered .............................................. 97Keypad lock ........................................................................... 98Alarms & remedies 99Alarms / alerts types.............................................................. 99

Re-displaying an alarm message .................................. 100“User Callback” alarm ........................................................ 101Syringe Empty Alarm Process ........................................... 101

“Syringe Near Empty” alarm ........................................ 101“Syringe Volume Near Empty” alarm ......................... 101“Syringe Empty” alarm ................................................. 102

System Advisory - Maintenance is Recommended ........ 102System Failures .................................................................... 102General system alarms & alerts ......................................... 103System Failure and Advisory Alarms ................................ 107

Battery Alarms ............................................................... 107System Failure Alarms .................................................. 108System Advisory Alarms ............................................... 108

Update(s) Available Notification ....................................... 110Battery and AC power operation 111On screen display of internal

battery power level gauge ........................................ 112Battery guidelines ......................................................... 112

Poleclamp assembly & use 113Rotating/detachable poleclamp (standard) ...................... 113

Assembling the rotating/detachable poleclamp......... 114Assembling the stationary poleclamp ......................... 115

EMC information for the Medfusion® Model 4000 pump .......................................................................... 116

Use of cables ................................................................... 116Stacked equipment ........................................................ 116

Technical specifications & other information 117Pump development standards ........................................... 117

Medical Electrical Equipment Safety .......................... 117Electromagnetic Compatibility .................................... 117Miscellaneous Standards ............................................... 119Compliance using: ......................................................... 120IEEE 802.11 b,g Radio for Auxiliary

Communication ........................................................ 123Technical specifications ...................................................... 124

Specifications .................................................................. 124Safety Features 128Safety Features and Fault Detection .................................. 128

Hardware Safety Features ......................................... 128

Software Safety Features ..................................................... 128Hardware-related Software Safety Features ........... 128Program Memory - Check FLASH memory

POST or BGND ..................................................... 128RAM Memory Check - RAM BGND .................... 128Motor Circuit Check - pump motor phase A or B

POST and Motor rate error during operation .. 128Keyboard Encoder Check - Control key POST

or BGND ............................................................... 128Data Handling Software Safety Features .......................... 128

Data Stored in EEPROM - Critical data POST or EEPROM timeout or Primary/Secondary critical data corrupted .......................................... 128

Data Used in Calculations - Critical data failure .. 128Timer Data Registers - Time base BGND, time of

day clock POST, time of day clock timeout ...... 129Additional Technical Information 130Medfusion™ Standard Syringes .......................................... 130

PharmGuard™ Supported Syringes (PSS) Series 2 ..... 130Flow rate & minimum volume by manufacturer

& size - Standard syringes ........................................ 131Concentration and dosing units ....................................... 133PharmGuard™ software limits ............................................ 133Configuration options......................................................... 134

General Options ............................................................. 134Program Options ........................................................... 136Auto Prompt Options .................................................... 137Device Setup Features ................................................... 138

Flow Delivery Graphs ......................................................... 138Start-up curves over stabilization period ............... 139Trumpet curves over T2 period .............................. 139

Communications ................................................................ 140Magnetic Resonance Imaging (MRI) Information ......... 140

MRI Related Testing ...................................................... 140Image Distortion ............................................................ 140

Cleaning and care ................................................................ 141Maintenance & service ....................................................... 142

Periodic maintenance .................................................... 142Using Smiths Medical USA service assistance ........... 143Returning a pump to the USA for repair .................... 144

Collect Separately ................................................................ 145Limited Warranty 146Index 147

Medfusion® Model 4000 pump Operator's Manual

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Important Safety InformationWARNING: Read this entire manual before us-ing the Medfusion® Syringe Infusion Pump, Model 4000 (Medfusion® Model 4000 pump). Failure to follow the instructions and important information contained in this manual, or improper/inadequate troubleshooting can lead to death or serious injury. Warnings, cautions and other important safety infor-mation can be found in this section, and throughout the manual (they are contained within lines above and below in the main part of the manual). See the Alarms and Remedies section for information on troubleshooting pump alarms.The term WARNING is used in this manual to indi-cate a hazard that has the potential to cause injury or death to a patient or user. The term CAUTION is used to indicate a hazard that has the potential to cause damage to the product or other property.

Warnings• Toavoidriskofexplosion,neverusepumpin

presenceofflammableanesthetics,oxygen-en-richedatmospheres,orexplosivegases.

• Duetoriskofexplosion,neverusethispumpinsideahyperbaricchamber.Ifthepatientisplacedinahyperbaricchamberwhileconnectedtoapumplocatedoutsidethechamber,deliveryaccuracycanbeaffected.DuetopressurechangesontheIVtubing,under-deliverycanoccurduringcompression,andover-deliverycanoccurduringdecompression.

• MedicalElectricalEquipmentneedsspecialpre-cautionsregardingEMCandneedstobeinstalledandputintoserviceaccordingtotheEMCinfor-mationprovided.

• PortableandmobileRadioFrequency(RF)com-municationsequipmentcanaffectmedicalelectri-calequipment.

• ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassAdigitaldevice,pursuanttopart15oftheFCCrules.Theselim-itsaredesignedtoprovidereasonableprotectionagainstharmfulinterferencewhentheequipmentisoperatedinacommercialenvironment.Thisequipmentgenerates,uses,andcanradiateradiofrequencyenergyand,ifnotinstalledandusedinaccordancewiththeoperator'smanual,maycause

harmfulinterferencetoradiocommunications.Operationofthisequipmentinaresidentialareaislikelytocauseharmfulinterferenceinwhichcasetheuserwillberequiredtocorrecttheinterfer-enceathisownexpense.

• Thisequipment/systemisintendedforusebyhealthcareprofessionalsonly.Theequipment/sys-temmaycauseradiointerferenceormaydisrupttheoperationofnearbyequipment.Itmaybenecessarytotakemitigationmeasures,suchasre-orientingorrelocatingtheMedfusion®Model4000pumporshieldthelocation.

• Theunauthorizedmodificationofthisproductmayconstituteasafetyhazard,whichcouldleadtopatientinjuryordeath,aswellasthepotentialforpropertydamage(includingtheriskoffire).UseonlySmithsMedicalsuppliedservice/replacementparts,includingthebatterypack.Unauthorizedmodificationand/ortheuseofunauthorizedser-vice/replacementpartswillalsovoidtheLimitedWarranty.

• ThisdevicecontainsanRFtransmitterwhichmayinterferewithaircraftsystems.

• BeforeusinganyMedfusion®Model4000pump,usersmustbethoroughlyfamiliarwiththecon-tentsoftheoperator'smanual,includingallwarn-ings,cautions,andinstructionsforuse.

• Thissyringeinfusionpumpisintendedforuseonlyunderthedirectionoftrainedmedicalpro-fessionals.

• DonotuseontheinletsideofExtracorporeal Membrane Oxygenation(ECMO)systemswherethenegativepressureisgreaterthannegative100mmHgasthehighnegativepressurescanresultinuncontrolledfluidflow.

• Theusershouldensurethattheperformanceof-feredbythepumpisfitfortheintendeduseandthatthepumpisnotusedinanywayorforanypurposeotherthanitsintendedpurpose.

• Thispumpisnottobeusedinanyintra-articularspaceinfusion.

• ThepumpmustbepositionedinanMRenviron-mentsuchthatitissecured to a non-moveable ob-jectandthemagneticfringefielddoes not exceed


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150 gauss.ExposingtheMedfusion®Model4000pumptomagneticfieldsthatexceed150gausspresentsariskofbecomingaprojectilehazardandcanleadtopossiblepatientinjuryordeath.Irreversibledamagetothepumpcanalsooccur,renderingitinoperable.

• Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatadeliveryrateotherthanthatprescribedwillcauseinappropriatedelivery.

• Alwaysreadmanufacturerprecautionsandguide-linesformedications,fluids,syringesandadmin-istrationsetsusedwiththispump.Medicationsorfluidsmayinteractwiththeplasticcomponentsoftheinfusionsyringeandsets.

• OnlyusetheMedfusion™StandardSyringes(sup-pliedwithPharmGuard®Toolbox2,andincludedintheMedfusion™StandardConfiguration),orthemodelsandsizesavailableaspartofthePharmGuard™SupportedSyringes(PSS)Series2,andalwaysconfirmthatthesyringemodelandsizedisplayedonthepumpmatchesthemodelandsizeloadedintothepump.Useofunapprovedsyringesmaycauseimproperpumpoperationresultingininaccuratefluiddeliveryorocclusionsensingorotherpotentialhazards.

• Verifythattheplungerholderssecurelycapturethesyringeplunger.Makesuretocapturethesy-ringebarrelandflange.Failuretoproperlysecurethesyringecouldresultinuncontrolledfluidflowtothepatient.

• AlwaysusethePrimefunctiononthepumpwhenloadinganewsyringeinordertoremoveanymechanicalslack.FailuretoprimecorrectlycandelayinfusiondeliveryandcauseTotal Volume Deliveredtoreadhigherthanwhatisactuallyde-liveredtothepatient.

• Periodicallycheckthefluidpathwayandallcon-nections(includingthecatheter/administrationsetconnection)forleaks.Leaksinthesystemmaycausefluidlossresultinginunder-delivery,aswellasallowinganopeningforcontamination.

• Alwaysturnofffluidflowtopatientintubingviaclamporstopcockbeforeloadingorunloadingasyringe.Uncontrolledfluidflowcanoccurwheninfusionsetisnotclampedorturnedoffresulting

ininappropriatedeliveryrate.• NEVERprimeanysyringewhileconnectedtoa

patientinfusionsite,asthismaycauseover-infu-sion.

• Toavoidairembolism,alwayspurgeallairfromsyringeandinfusionlinesbeforeconnectingtothepatient.

• Oncethesyringeandtubingsystemisconnectedtothepatient,raisingthesystemabovethepatient(evenbriefly)cancausesignificantbolusingduetochangesinhydrostaticpressure.Loweringthesystembelowthepatient(evenbriefly)cancausesignificantinterruptionsinflowduetochangesinhydrostaticpressure.Thiscouldcauseimproperpumpoperationresultingininaccuratefluiddeliv-ery.Placethepumpasclosetothepatient'sinfu-sionsiteaspossible.

• Usethesmallestsyringesizenecessarytodeliverthefluidormedication.Usingalargesyringeatverylowrates(belowMinimumRecommendedRateforthesyringe)maycauseimproperpumpoperation,delayedocclusionsensing,largerpostocclusionbolusathigherocclusionlimitsettings,deliveryinaccuracies,orotherpotentialhazards.Bolus Volume:Deliveringabolusvolumelessthentherecommendedbolusvolumeforthesyringeusedmayresultindeliveryinaccuracies.Useaninfusionsetwiththesmallestdiametertubingavailablethatdoesnotresultinexcessivebackpressureatthedesiredflowrate.Considerprim-ing,loading,bolus,andflushrateswhenselectinganinfusionset.

• LargersizesyringesatocclusionsettingHIGHmayproduceapostocclusionboluslargerthan0.3mLduetoexcessivesyringeplungertipcompli-ance.

• WhenusingQuicklibraries,presetvaluesareautomaticallyinsertedwithoutpausingtoverifyeachsetting.TheBegin Infusionscreendisplaysimmediatelyafterselecting/confirmingthedrugprogram.Verifytheinfusionparametersbeforestartingthedelivery.Certaindatafieldsmaynotbeprogrammed(e.g.patientweight)andrequiredataentrybeforetheinfusionwillproceed.

• Ifasystemfailurealarmoccursandcannotbeclearedbypoweringthepumpdownthenbackup,thepumpcannotbeused.Removeitfromuse


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andsendittoatrainedbiomedicaltechnicianforservice.

• Electric Shock hazard.Theonlymeansofremov-ingACpoweristodisconnecttheACpowercord.WhiletheACpowercordisattachedtothepumpandpluggedintoanACoutlet,livemainsvoltageispresentinsidethepump.

• Ensurethatthe±2%accuracyspecification(±syringeaccuracy)istakenintoaccountwhenprogrammingthepumpand/orfillingasyringe.Ifaccuracyisofprimeconcern,useonlysyringesthatmeetthe±2%requirementoftheISO7886-2Standard.Failuretodosomayresultinmedica-tioninthesyringebecomingdepletedsoonerorlaterthanexpected.

• Useofcablesotherthanaslistedandwithequip-mentotherthanthosespecifiedmayresultinincreasedEMCemissionsordecreasedimmunityofthepump.Itisrecommendedthatwhencon-nectingthepumptoanetworkusinganEthernetcable,thenetworkequipmentshouldconformtoEN/IEC60950.

• Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigura-tioninwhichitistobeused.

• Toavoidelectricshock,beforecleaning,alwaysswitchelectricallyoperatedequipmentoffanddisconnectfromACpowersource.

• Toavoidelectricshock,onlytrainedbiomedicalservicepersonnelmayservicethispump.ServicepersonnelshoulddisconnecttheACpowercordbeforeservicingthepump.

• Alwaysmaintainthispumpfollowingmanufac-turer recommended instructionsintheTechnicalServiceManual.Improperlymaintainedpumpsmaycauseeitherunder-infusionorover-infusiontopatient.

• Toavoidelectricshock,usersshouldneveropenthepumpcaseorbatterycompartmentforanyreason.Servicepersonnelshouldalwaysdiscon-necttheACpowercordbeforeservicingthepump.

• Neveruseadroppedorobviouslydamagedpump.Withdrawitfromserviceuntilatrainedbiomedi-caltechniciancantestit.

• Therearepotentialhealthhazardsassociatedwithimproperdisposalofbatteries,electronics,andcontaminated(used)infusionsetsandsyringes.Disposeofusedbatteries,infusionsets,syringes,andotherusedaccessories,orapumpthathasreachedtheendofitsusefullife,inanenviron-mentallysafemanner,andaccordingtoanyregu-lationsthatmayapply.


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Cautions• Federal(USA)lawrestrictsthisdevicetosaleby

orontheorderofaphysician.• ALWAYSverifythatthesoftwareversionofthe

pump(displayedonscreenduringpower-up)andOperator'sManualarethesame.Refertothismanual’sfrontpage.

• NEVERusesharpobjectstodepresskeypadkeysonthepump.Thismaydamagethepumpbyren-deringkeypadkeysinoperable.

• Thispumpisdesignedtobeusedinahorizon-talposition.Ifthepumpisoperatedinaverticalposition,thereisanincreasedpotentialforfluidleakingintothepump.Iffluidleakageintoapumpissuspected,removeitfromuseuntilatrainedbiomedicaltechniciancantestit.

• Alwaysverifythestabilityoftheobjecttowhichthepumpismounted(forinstance,anIVpole)usingthepoleclamp.Failuretoverifythestabilitycouldcausetheobjecttotip,withthepossibilityofcausingdamagetothepumpandotherequip-mentIfthepoleclampisnotadequatelytightened,itcouldcausethepumptofall.

• NEVERuseorganicsolvents(e.g.,acetone),quarternaryammoniacompounds,strongacids,orbasestocleananyportionofthepumpasthesecompoundsmaydamagethepump.

• Thepumpis“sprayresistant”fromthetopandsidesbutnot“waterproof ”.NEVER sprayclean-ingorotherfluidsdirectlyintoopeningsonthebottomofthepumpaspumpdamagemayoccur.

• Thepumpisnotcertified“waterproof ”.Neverim-mersethepumpinwaterorotherfluidsasthiscanrenderthepumpinoperable.

• NEVERuselightoilsprays(e.g.,WD40®)tocleanorlubricatepump.Theseoilscontainchemicalsthatcandamagetheplasticofthepump.Nouser-addedlubricationisnecessary.

• NEVERsterilizethepumpinasteamautoclaveorgassterilizer.Usingautoclaveorgassterilizationcanseriouslydamagethepumpandwillvoidthewarranty.


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SymbolsThefollowingisalistofsymbolswhichmayappearonthepump(oronitslabelingoraccessories),aswellascertaintechnicalterms,alongwithanexplanationofwhattheymean.

> Serialnumber

f Caution

J TypeCFequipment(protectionfromelec-tricshock)

K ClassIIEquipmentinwhichprotectionagainstelectricshockreliesondoubleorreinforcedinsulationinsteadofbasicinsula-tion.Accessiblemetalcomponentsofpumpenclosureusethishigherlevelofinsulationinsteadofsafetygrounding.

J Dateofmanufacture

6 CAUTION:Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofaphysi-cian.

< Catalognumber

nol Latexfree

7 Donotreuse

8 Useby

ULMarkforCanadaandtheUnitedStates.IndicatestheproductwasmanufacturedinaccordancewiththerequirementsofUL(Underwriter’sLaboratory).

P Temperaturelimitation

_ Humiditylimitation

i Atmosphericpressurelimitation

ED E=WiredConnection,D=DeviceServerConnection

WD W=Wirelessconnection,D=DeviceServerConnection

V ~ Operatingvoltagerangeforalternatingcur-rent(i.e.ACormains)powersource

IPX3 Equipmentthatisingressprotectedfromfluidsprayingataverticalanglefromabove,andfromanglesto60°oneithersideofvertical

î Non-ionizingradiation

MR(MagneticResonance)Conditional

CCK Australianc-tickmark.Indicatesthattheproductcomplieswiththeapplicablestan-dardandestablishesatraceablelinkbe-tweentheequipmentandthemanufacturer,importerortheiragentresponsibleforcom-plianceandforplacingitontheAustralianorNewZealandmarket.

Ü Pinsofconnectorsandotherareasidenti-fiedwiththisESDWarningsymbolshouldnotbetouched.ConnectionsshouldonlybemadewhenESDprecautionarymeasuresareused.

Z CollectSeparately

Foranexplanationofthesymbolsthatappearonthepumpkeypad,see“Keypad Closeup”andthetablesthatfollow(page9).


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IntroductionCAUTION: ALWAYSverifythatthesoftwareversionofthepump(displayedonscreenduringpower-up)andOperator'sManualarethesame.Refertothismanual’sfrontpage.

TheMedfusion®Model4000pumpisasmall,light-weightandportablesyringeinfusionpump.Thepumpoffersavarietyofdeliverymodesprogrammabletomeetspecificpatientcareneeds.Theactualmodesavailableinagivenpump,andtheirlocationonagivenscreen,dependonthecustomsetup.Fluidscanbedeliveredfromavarietyofsyringesizes(1-60mL)andsyringemanufacturersinvariousdeliverymodes.TheMedfusion®Model4000pumpisequippedwithPharmGuard®MedicationSafetySoftware,anintui-tivesystemdesignedtoenhancesafetywhilemain-tainingsimplicity,whichcanallowstreamlinedimple-mentationandimprovedworkflow.ApumpConfigurationiscreatedonaPCusingthePharmGuard®Toolbox2software,andthentheConfigurationissenttothepump.TheConfigurationmaycontainglobalsettings,Profiledefinitions,librarydefinitions,DrugProgramsandsyringedefinitions(seepage15fordiscussionaboutlibraries).TheMedfusion®Model4000pumpimportsandexportsdatatoassistinhistorydatamanagement.ThepumpcommunicateswiththePharmGuard®ServerusingWirelessandEthernetinterfaces.WithitswiredorwirelessEthernetconnection,bi-directionalcom-municationofConfigurationandinfusiondataispos-sibletoandfromtheMedfusion®Model4000pumpviayourinstitution’snetwork.PumpConfigurationsandfirmwarecanbeupdated,andinfusionsettingsandeventshistorydownloadedincombinationwiththePharmGuard®Toolbox2softwareapplicationandthePharmGuard®Server.ThepumpalsohastheFlowSentry™rapidocclusiondetectionfeature,whichisacomprehensivearrayofpressure-relatedsafetyfeatures,includingrapidalarmresponseandreducedfalsealarms.Pressuretrendingisshowninthepumpdisplay,allowingearlieroppor-tunitiesforintervention,aswellasapost-occlusionbolusreductionfeature.

Indications for useTheMedfusion®Model4000SyringeInfusionPumpisindicatedforthefollowinguses:• Intheadministrationoffluidsrequiringprecisely

controlledinfusionratesincludingbloodorbloodproducts,lipids,drugs,antibiotics,enteralsolu-tionsandothertherapeuticfluids.

• Bythefollowingdeliveryroutes:arterial,epidural,intravenous,intrathecal,subcutaneous,anden-teral.

• Bythefollowingdeliverymodes:continuous,volume/time,mass,bodyweight,intermittentandbolus.

• Incriticalcare,anesthesia,neonatalandpediatricapplicationsorotherhealthcaresettingswheretheuseofthesyringeinfusionpumpcanbemoni-toredorsupervisedbyaclinician.

• InsidetheMRIroommountedoutsidethe150Gausslineandwithshieldedmagnetsoffieldstrengthof1.5Tesla.

WARNINGS: •BeforeusinganyMedfusion®Model4000pump,usersmustbethoroughlyfamiliarwiththecontentsofthisOperator’s Manual,includingallwarnings,cau-tions,andinstructionsforuse.•Theusershouldensurethattheperformanceofferedbythepumpisfitfortheintendeduseandthatthepumpisnotusedinanywayorforanypurposeotherthanitsintendedpurpose.•Thispumpisnottobeusedinanyintra-articularspaceinfusion.•Thissyringeinfusionpumpisintendedforuseonlyunderthedirectionoftrainedmedicalprofessionals.•Ifthepumpisusedtodeliverlife-sustainingmedi-cations,anadditionalpumpmustbeavailableforsituationswhereaninterruptionininfusioncouldbedangerous.•ThepumpmustbepositionedinanMRenviron-mentsuchthatitissecured to a non-moveable objectandthemagneticfringefielddoes not exceed 150 gauss.ExposingtheMedfusion®Model4000pumptomagneticfieldsthatexceed150gausspresentsariskofbecomingaprojectilehazardandcanleadtopossible


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patientinjuryordeath.Irreversibledamagetothepumpcanalsooccur,renderingitinoperable.

CAUTION: NEVERusesharpobjectstodepresskey-padkeysonthepump.Thismaydamagethepumpbyrenderingkeypadkeysinoperable.

• OnlytheMedfusion™StandardSyringes(suppliedwithPharmGuard®Toolbox2,andincludedintheMedfusion®StandardConfiguration),ortheaddi-tionalsyringemodelsandsizesavailableaspartofthePharmGuard™SupportedSyringes(PSS)Series2(seepage21),maybeusedonthepump.

• Ensureallmedicationsorfluidsarecompatiblewiththesyringe,catheters,tubing,andfittingsusedintheinfusionsetup.

• Alwaysensurefluidsarecompatiblewitheachotherwheninfusingmorethanonefluidormedi-cationthroughthesameinfusionsite.Ifconnect-ingmorethanonepumptothesameinfusionsite,useone-waycheckvalvestopreventpumpsfrominterferingwitheachother.Verifythatthepumpswilloperatetogetherwithoutalarming.

ContraindicationsWARNING:ECMO use:DonotuseontheinletsideofExtracorporeal Membrane Oxygenation(ECMO)systemswherethenegativepressureisgreaterthannegative100mmHgasthehighnegativepressurescanresultinuncontrolledfluidflow.


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About the pump

Features and ControlsFollowingareseveralillustrationsshowingthevariouscontrols,connectorsandfeaturesoftheMedfusion®Model4000pump.

8 Syringe Plunger Release Lever:Squeezethereleaselevertoallowplacementofthesyringeplungerontotheholderduringloading,ortoremoveitduringunloading.

9 Keypad:SeeKeypadcloseup(nextpage)foriden-tificationoftheindividualkeypadkeysandwhattheyareusedfor.

1 Display:allpumpoperatingandstatusinforma-tionappearsonthedisplay.Thelowerportionofthedisplaycorrespondswiththe4‘softkeys’(theirfunctionchangesdependingonthepumpprogrammingbeingaccomplished)onthekey-pad.

2 Tubing Holders:Threadinfusionsettubingbe-tweenholderstopreventkinkingatsyringetip.

3 Carrying Handle

4 Syringe Barrel Clamp:Theclampholdsthesyringebarrelsecurelyinplace.

5 Syringe Barrel Flange Clip:Whenloadingasy-ringe,slidethesyringeflangeintotheclip.

6 Syringe Plunger Holders:Holdsthesyringeplung-ersecurelyinplace.

7 Syringe Plunger Driver:Onceloadedanddeliveryisstarted,thedriverpushestheplungerforwardatacontrolled,preciseratetodeliverfluid.

*

PRIME / BOLUS

*


9

10 AC Power Connection Port:PlugtheACpowercordintoconnectionporttoallowpumptoop-erateonAC(mains)power.

11 Ethernet Port:PluganEthernetnetworkcableintotheporttoreceiveandsendConfigurationsanddata.

12 Optional Poleclamp Mount:Ifdesired,attachtheoptionalpoleclamphere.

13 Pump Base / Bottom

Keypad closeup

G6000912 Rev 0

PRIME / BOLUS


10

Key When pump is paused When pump is delivering

Alarm Silence (í)Silencesaudiblealarm.Allowsopera-tortoswitchthedisplaybacklightfrombrighttodimordimtobright.Allowsredisplayofthetextforthelastactivealarm.

Silencesaudiblealarm.Allowsoperatortoswitchthedisplaybacklightfrombrighttodimordimtobright.

Power (ë) Silencecertainactivealarms.Pushandholdtoturnpumpoff.

Silencecertainactivealarms(somealarmsmustbesilencedwithíbeforeëwillfunction).Pushandrelease,thenpushandholdtoturnpumpoff.

Menu keys (softkeys) Functionisdefinedonthedisplay. Functionisdefinedonthedisplay.

Back (â) Revertstoaprevioussteporlevel. Revertstoaprevioussteporlevelifadjustingsettings.Brieflydisplaysthebatterylifeindi-cator,networkconnectiontype,dataserverstatusandPDD/PVD.

Numbers & Decimal Setnumbervaluesorselectsmenuitems.

Setnumbervaluesorselectsmenuitems.

Stop (á) N/A Stopsdelivery(pumpremainson).

Start (É) Startsdelivery. N/A

Prime / Bolus (è) Beginsprimingafterconfirmation. Displaystheprogrammedbolusprogrammingorconfirmation/Begin Deliveryscreen.

Indicator What it means

ò - Alarm TheAlarmindicators(yelloworred)areonwheneverthepumpisinanalarmcondi-tion.ThespecificdetailsofeachalarmarecoveredintheAlarmsectionlaterinthismanual.

ô - AC Line TheAC Lineindicator(green)isonwheneverthepumpisconnectedto“mains”linepower.ItisoffwhenthepumpisnotconnectedtoanactiveACline.

õ - Battery TheBatteryindicator(green)blinkson&offwheneverthepumpisoperatingoninter-nalbatterypower,andremainsonwhenbatteryischarging.

ö - Lock TheLockindicatorindicatesthepumphasbeenlockedintoitscurrentoperationalmode.Whilethisindicatorislit,thekeypadislockedandnochangescanbemadetosettings.Attemptingtostoporchangeaninfusionwhilelockedwillresultinanalarmandaninformationalmessage.

ù - Infusing TheInfusingindicatorsare3greenlights,whichilluminateinsequencerighttoleftwhenthepumpisinfusing.Duringintermittentvolumeovertimedeliverymode,asingleInfusingindicatorlightsduringthetimebetweeninfusions.Whenthepumpisofforstopped,theInfusingindicatorisnotlit.

- Communicating TheCommunicatingindicator(blue)isonwheneverthepumpiscommunicatingwiththePharmGuard®Serverusingwirelessorwiredinterface.Thereisnoaudibletoneassociatedwithcommunications.Duringnormalnetworkoperationsthelightmayperi-odicallyturnonandoff.TheCommunicatingindicatorhasnoaffectonclinicalopera-tionsofthepump.


11

Network ConnectionsThepumpcanbeconnectedtothePharmGuard®Serverand/ortothePharmGuard®Toolbox2Software.Whenthepumpisconnectedtothenet-work,therearetwoconnectivitystates:WirelessandEthernet.Ethernet (wired connection):Whenthepumpiscon-nectedtoEthernet,itautomaticallydefaultstocom-municatingoverEthernet.Wireless:WhenanEthernetconnectionisnotpres-ent(andtheWirelessInterfaceisenabled),thepumpcommunicatesviaWireless.Theblue“Communicating”lightisonwheneverthepumpiscommunicatingwiththePharmGuard®Serverusingwirelessorwiredinterface.

Note:Tosetupanetworkconfiguration,seethepro-cedureprovidedintheMedfusion®Model4000Net-workSettingsManual(“NetworkConfiguration”),theinstructionsprovidedwiththePharmGuard®Server,andworkwithyourITpersonnelasneeded.

Ethernet StateThepumpdisplaysthe‘ED’iconwhenthepumpisconnectedtothePharmGuard®ServerusingtheEthernetconnection.Firstan‘E’iconisdisplayedwhentheEthernetconnectionisestablished,thenan‘ED’iconwhentheconnectiontothePharmGuard®Serverisalsoestablished.

Wireless StateThepumpdisplaystheicon‘WD’whenthepumpisconnectedtoPharmGuard®ServerusingaWirelessconnection.Firsta‘W’iconisdisplayedwhentheWirelessconnectionisestablished,thena‘WD’iconwhentheconnectiontothePharmGuard®Serverisalsoestablished.

Connected to ToolboxWhenExternalCommandsareenabledinBiomedmode,thepumpcanbeconnectedtoPharmGuard®Toolbox2.

Network ConfigurationTheMedfusion®Model4000pumpprovidesatelnetservertoenableperformanceofconfigurationtasks

throughasimplecommandlineinterfacefromatel-netclientprogram.Thepumpacceptsincomingconnectionsfromthenetworkusingtelnet.Thetelnetconfigurationinter-facesupportsauserdefinabletelnetpassword.ThepumpmusthaveExternalCommandsenabledinbiomedmodetousetelnet.

Attaching the Pump to the NetworkSeetheMedfusion®Model4000NetworkSettingsManualforinstructionsinhowtoattachthepumptothenetwork.

Network statusBrieflydisplaythenetworkstatusatanytimewhilethepumpisinfusingbypressingâ.

PVD 0.55 mL

RATE 10 mL/hr

LOCK

N

CHG RATE OPTIONS CLEAR TVD

100%B-D 60mL E

Example of communications state icon


12

Pump Customization and General Programming

Custom ConfigurationGenerallyspeaking,pumpcustomizationisperformedbeforeapumpisusedonapatient(seethegraphonpage13).CustomizationisaccomplishedusingPharmGuard®Toolbox2.OncethecustomConfigurationiscre-atedandvalidated,PharmGuard®Toolbox2orthePharmGuard®Serverisusedtosendittooneormorepumps.WhensendingConfigurationsus-ingthePharmGuard®Server,allMedfusion®Model4000pumpsconfiguredtocommunicatewiththePharmGuard®ServerwillreceivetheConfiguration.Dependingonthesettingsandfeatureschosenincus-tomization,certainfeaturesmayormaynotbeavail-ablewhenprogramminganyspecificpump.Eachuserisresponsibletodeterminewhichfeaturesarepresentonthepumptheyareusingandtoprogramthemac-cordingly.Forthisreason,thefollowingwarningisincludedthroughoutthestepsforprogramminganddeliveringfluidsthroughoutthismanual:

WARNING: Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatadeliveryrateotherthanthatprescribedwillcauseinappropriatedelivery,whichcanresultinseriousinjuryordeath.


13

PharmGuard® Toolbox V2 CreateacustomConfiguration(settingsandDrugPrograms),validateConfiguration,thensendtopumpusingPharmGuard®ToolboxorPharmGuard®Server(seetheproductliteraturesuppliedwiththese

productsformoreinformation)

Types of Delivery Modes Possible

Dose / Day Dose / m2 / Min mL / Kg / TimeDose / Hour Dose / Min Volume Over TimeDose / Kg / Day Dose / Time Dose / Kg / TimeDose / Kg / Hr Intermit Volume / Time Dose / M2 / TimeDose / Kg/ Min mL / Hr Dose / m2 / Day mL / Kg / Hr Other mode:Dose / m2 / Hr mL / Kg / Min Recall Last Settings

These are the types of infusion modes possible. Some are manual (in that they can be used in Drug Programs or can be menu items on their own), while others can only be used in the creation of Drug Programs (such as Dose / Kg / Time and Dose / M2 / Time)

Possible Options

Bolus DoseDelayed StartKVOLoading DoseOverride Alarm LoudnessOverride Occlusion LimitPeriodic Callback Alarm StandbyToggle Empty ToneToggle FlowSentryToggle Near Empty ToneToggle PVD / PDDVolume Limit

Not all options are available in all delivery modes or Drug Programs

Send Configuration

Flush feature may be used in some modes

The Customization Process

Medfusion® 4000 Infusion Pump“Medfusion™StandardConfiguration”includesmanualdeliverymodesandavarietyofsyringes.NoDrugProgramsorOptionsareavailableintheStandard

Configuration

Medfusion® Model 4000 Pump

WithCustomConfiguration


14

General ProgrammingTheMedfusion®Model4000pumphasavarietyofdeliverymodesthatarecustomizablebytheuser.Theactualmodesavailableonagivenpump,andtheirlo-cationonagivenscreen,dependonthecustomsetupperformed.AllcustomizationisaccomplishedusingthePharmGuard®Toolbox2software,includingwhichsyringesandfeaturesareavailableonthepump,aswellashardandsoftlimitsonvalues(seebelowandpage19fordiscussionabouthardandsoftlimits).Themodesandprogrammingstepsdescribedinthischapter,andthestepsgivenforprogrammingthem,arebasedongeneralsetupparameters.Whichofthefeaturesandfunctionsareavailableonaspecificpump,andhowthescreensassociatedwiththemappear,dependsentirelyonhowthepumpwascustomized.Ifthefunctionsandscreensonapumplookdifferentthanthoseshownhere,itisduetothiscustomization.Itispossiblethatapumpiscustomizedsothatanin-fusioncannotbeprogrammedwithoutfirstenteringauserID,orsothatcertainprofilescannotbeaccessedwithoutfirstenteringapasscode.Ifthatisthecase,youwillbepromptedtoenteranIDorapasscodewhenattemptingtoprogramaninfusion.

WARNING: Alwaysreadmanufacturerprecautionsandguidelinesformedications,fluids,syringesandadministrationsetsusedwiththispump.Medicationsorfluidsmayinteractwiththeplasticcomponentsoftheinfusionsyringeandsets.Thisinteractionmayresultinseriousinjuryordeath.

Exceeding limitsThepumphastwotypesofprogrammedinfusionlimits,HardlimitsandSoftlimits.• Hard Limits–Values that cannot be exceeded

under any conditions.HardlimitsshowupasMaxandMinonthepump.Ifyoutrytoexceedahardlimit,ascreensimilartothefollowingfiguredis-plays.

BACKSPACE ENTER

INPUT OUT OF RANGE - GREATER THAN MAX VALUE

CLEAR

mL62DISABLE

MAX: 59HIGH: 50LOW: 10MIN: 1

Thepumpthenpromptsyoutoenteranewvalue.• Soft Limits-The normal range.SoftLimitsshow

upasHighandLowonthepump.Theyarethenormalupperandlowerlimits.YoucanenteravalueaboveorbelowtheHighorLowlimit(solongasitdoesnotexceedtheMinorMax).Ifthesoftlimitsareexceeded,thepumppromptsyoutofirstsilenceanalarm,thenconfirmorcanceltheoverridecondition,asshowninthefollowingscreen.

NO

CONFIRM LIMIT OVERRIDE?

OVERRIDE

mL55MAX: 59HIGH: 50LOW: 10MIN: 1

ItispossiblethatapumpiscustomizedsothatlimitscannotbeexceededunlessauserIDisentered.IfthatisthecaseyouwillbepromptedtoenteranID.“Limit”stylealertsareadvisoriesthatoccurforvariousreasons(usuallyduringprogramming).Anon-repeatingaudioalarmsoundsandamessageisdisplayedfor3seconds.Tore-displaythealertmes-sage,pressí.Thepumprecordsexceededlimitsandattemptstoexceedlimits.

How pump settings and limits are prioritizedTherecanbeanumberoflimitsimposedonpumpsettings,forinstancetherateislimitedbythesyringesizebeingused,aswellasanyhardand/orsoftlimitsimposedinthedrugprogram.Themostrestrictivelimittakespriority.Additionally,availableOptionsfordeliverycanbesetforprofilesaswellasindividualdrugprograms.Inthesecases,thesettingsforthedrugprogramtakepri-orityoverprofilesettings.Forexample,theBolusop-tionmaybeenabledforaprofile,butadrugprogramwithinthatprofilemayhavethebolusoptiondisabled.


15

User defined pump ConfigurationsThischapterdescribestheMedfusion®Model4000pumpConfiguration.

What are Configurations?AConfigurationisadatabaseofpumpsettingsorga-nizedintoProfiles,CategoriesandDrugPrograms.TheConfigurationhasglobalsettingsthatareap-plicabletothepumpoperations.TheConfigurationmayhaveupto16Profiles.EachProfilehasasetofProfile-levelsettingsandalsoupto8Categories.EachCategorymaycontainupto36DrugPrograms.ThereisaspecialcategorycalledaQuickLibrary.AQuickLibrarycontainsDrugProgramsthathaveallinfusionparameterspre-specifiedtoallowquickstartofaninfusion.AConfigurationisdefinedhereasastoredrecordofinfusionsettingsthatloadfrommemory.Theseprogramsarestoredinmemoryindefinitely(over10years)oruntiloverwritten.TheConfigurationissetupusingPharmGuard®Toolbox2.Whenitiscompleteditshouldbevalidatedbythepersonresponsibleforcustomconfigurationbeforethepumpsaredeliveredtoaworkarea.

When are Drug Programs used?Everyunit,department,organization,orhospitalhasstandardwaysofdeliveringmedicationsorfluids.Thecustomsetupenablesyoutouseprogramsofstored presets.UsingthePharmGuard®Toolbox2Software,thePharmGuard®Toolbox2Administratorwillestab-lishthepumpConfigurationthatimplementsthestandardinfusionsfortheunit,department,organi-zation,orhospital.ThisprocessisdescribedinthePharmGuard®Toolbox2User’sManual.

Who can use these Drug Programs?Anyonewhoisauthorizedtousetheinfusionpumpcanuseprogramsfromtheavailablelibraries.

Types of programmable Library CategoriesTherearetwotypesoflibrarycategoriesintheMedfusion®Model4000pumps:

Library Category Type

What it does

Standard Standardlibrarycategoriescontainpro-gramswithparametersthatareappliedwhenprogramminganinfusion.Theselibrariesrequireyoutostepthroughandrevieweachsetting.Thisallowsmodifyingstandardsettingswhilesteppingthroughpresetvalues.

Quick Aquickcategorycontainsdrugprogramswiththepresetsnecessaryforprogram-minganinfusion.However,theydonotpauseateachlevelforyoutoenterthesettings.Instead,the entire set of values is pro-grammed at one step including syringe model and size.TheBegin Infusionscreen,whereallinfusionvaluesareshown,displaysatonce.Atthatpoint,youconfirmallthesettingsarecorrect,thenpressÉtobegindelivery.

WARNINGS: Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatade-liveryrateotherthanthatprescribedwillcauseinap-propriatedelivery,whichcanresultinseriousinjuryordeath.WhenusingQuicklibraries,presetvaluesareau-tomaticallyinsertedwithoutpausingtoverifyeachsetting.TheBegin Infusionscreendisplaysimme-diatelyafterselecting/confirmingthedrugprogram.Verifytheinfusionparametersbeforestartingthedelivery.Certaindatafieldsmaynotbeprogrammed(e.g.patientweight)andrequiredataentrybeforetheinfusionwillproceed.

Displaying Quick library Options:Thestepsinthissectionarehypothetical.TheMedfusion®Model4000pumpisshippedwithaMedfusion™StandardCon-figuration,andwithoutanyProfiles,CategoriesandDrugPrograms.SotheactualQuicklibrariesavailabledependentirelyonthecustomConfigurationsenttothepump.


16

1 3% SaLine mL/kg/time2 abeLcet 2 mg/mL3 acycLovir (Zovirax)(kg doSing)4 ambiSome 2 mg/mL

PAGE

PRESS NUMBER TO SELECT1/8

PREV NEXT

Using a Custom ConfigurationPharmGuard®Toolbox2allowsafacilitytocreateacustomConfigurationandsendittothepumpforuse.IfprofilesarecreatedintheConfiguration,thepumpdisplaystheProfileMenu.Ifthedesiredprofileisn'tdisplayedonthefirstscreenpressMoreforadditionalselections.

1. Ifaprofilelistingisn'tdisplayedontheSelect the Profilemenu,pressMoretofinditonanotherscreen;otherwiseitisnecessarytocreatethatprofileusingPharmGuard®Toolbox2.Forexample,if“4”atrightisselected,theGeneral Pedsprofileopens(profilesnamesarecustomizedperfacilitypreference,sowillnotbethesameasthoseshowninthefollowingscreens).

2. Librarycategoriesintheprofilearedisplayed.Selectacategoryfromthemenu.Forexample:if“1”atrightisselected,thenthedrugprogramcategoryGen Peds A - Dopens.

3. CustomdrugprogramsaredisplayedontheDrugProgramscreen.Touseadrugprogram,usethenumberkeystoselectthedesireddrugprogram(seepage32forafullexplanationofthisscreen).

For example:ifentry“2”isselected,thepresetinfusionparametersforAbelcet 2 mg/mLischosen.

4. Youarenextpromptedtoloadasyringe,thenconfirm&accepteachlevelofsettingsbypressingEnter.Somedatafieldsmayrequiredatainputpriortoproceeding(e.g.PatientWeight).

WARNING: Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatadeliveryrateotherthanthatpre-scribedwillcauseinappropriatedelivery,whichcanresultinseriousinjuryordeath.

5. Whenallsettingsareconfirmed,theBegin Infusionscreenisdisplayed.UsethePrimefeature,thenpressÉtobegintheinfusion.

PRESS THE NUMBER TO SELECT THE PROFILE

MORE

1 aneStheSia 5 cardiac2 nicU 6 hem/onc3 PicU 7 ticU4 generaL PedS 8 ed

MORECHG PROFILE

PRESS THE NUMBER TO SELECT generaL PedS

1 GEN PEDS A - D 5 GEN PEDS Q - Z2 GEN PEDS E - I 6 bLood ProdUctS3 GEN PEDS J - M 7 enteraL FeedS4 GEN PEDS N - P


17

Using Quick LibrariesSmithsMedicalshipstheinfusionpumpwithMedfusion™StandardConfigurationthatdoesnotincludeaQuickLibrary.Theprofiles,categoriesandcustomdrugprogramsavailableonapumpdependontheconfigurationsetupbythepersonresponsibleforcustomconfigura-tion.QuickLibrariesisanoptionthatcanbeset-upincustomconfiguration.Thisoptiondesignatesacat-egoryinaprofileasaQuickLibrary.Aprofilewithquicklibraryenableddisplaysalistofcustomdrugprograms.

1 ProPoFoL 10 mg/mL2 vecUroniom 1 mg/mL (or)3 dobUtamine 200 mcg/mL (or)4 doPamine 1600 mcg/mL (or)

MAIN MENU


RatherthantheCHG Profilekeydisplayedonstan-dardlibrarycategoryscreens,theQuickLibrarywillhaveMain Menuonthefarleft.WhenMain Menuispressed,anotherselectionscreenisdisplayed,withtheadditionalcategoriesanddeliverymodesfortheselectedprofile.

MORE

1 Anesthesia A-D 5 Anesthesia Q-Z2 Anesthesia E-I3 Anesthesia J-M4 Anesthesia N-P

CHG PROFILE

PRESS THE NUMBER TO SELECT aneStheSia

QUICK LIBRARY

ThesoftkeyonthefarleftofthisscreenreflectsthenameoftheQuicklibrary(theaboveisanexampleonly).Pressthiskeytore-entertheQuicklibrary.TheQuicklibraryisexitedwhenMain Menuispressed.TheCHG Profilekeyrespondsthesamehereaswithallothers.

(Ifthereisonlyoneprofileonthepump,andaQuicklibraryisenabled,thedrugprogramsinthedesignat-edQuickLibrarywilldisplayonscreenafterthepumpisturnedonandcompletesitsselftests.)ThedrugprogramsinaQuickLibraryhavebeencus-tomizedwithdefaultvaluesforinfusionparametersthatmayinclude:syringemodelandsize,dose,vol-ume,weight,deliverytime,etc.Settingdefaultvaluesinthecustomprogramallowstheusertoproceedfromthedrugprogramselectionscreentothefinalconfirmationscreen(providedtheloadedsyringematchesthedefaultsyringeinthedrugprogram).TheQuickLibraryprogram’spresetvaluesareloadedautomaticallyintothepumpprovided that you have loaded a syringe of the manufacturer and size pro-grammed for this library entry.PressÉtobeginthepresetinfusionafterverifyinginfusionsettingsandusingthePrimefeature.Somedatafieldsmaybeblankandrequiredataentrytoproceed.


18

QUICK LIBRARY

CONC 10 mg/mL TVD 0 mLWEIGHT 75 KG KVOLOAD 2000 MCG/KGDOSE 75 MCG/KG/MIN RATE 33.8 mL/hr

CHG DOSE OPTIONS CHG WEIGHT

ProPoFoL 10 mg/mL aneStheSia

1. TouseQuickLibraryprogramsfromtheSelect screen,usethenumberkeystoselectadrugprogram.

For example:if“1”atrightisselected,thepumploadsthestoredsettingsforPropofol 10 mg/mlinfusionandpausesattheBegin Infusionscreen.

2. AlltheinfusionsettingsdisplayontheBegin Infusionscreen.Youhavetheoptiontochangethedefaultsettingsforweightanddoseusingthesoftkeysdisplayed.Allsettingsshouldbeconfirmedtoensuretheyarecorrect.Alwayschecktheinfusionsettings’accuracy.You are responsible for ensuring the safety of any infusion the pump is programmed to deliver.

3. UsethePrimefeature,thenpressÉtobegintheinfusion.


MAIN MENU



19

PharmGuard™ Safety Software: Dose Protocol ProtectionPharmGuard®MedicationSafetySoftwareprovidesprogrammableHardandSoftupperandlowerlimitsforinfusionparameters.RefertothePharmGuard™softwarelimitsintheTechnicalSpecificationssectionofthismanual(page133)foralistofallparametersthatmaybeprotectedwithPharmGuard™softwarelimits.

Soft limitsSoftlimitsarethenormallimits,andshowonscreenasHighandLow.Softlimitscanbeex-ceeded(solongastheHardlimitsorthephysicallimitsimposedbythesyringesizeinusearenotexceeded).1. Whenattemptingtoenterorchangeinfusion

parametersofadrugprogram,thesoftlimitsaredisplayedonscreenas“High”and“Low”.

2. Ifavalueisenteredthatisoutsidetherange,anaudiblealarmsoundsandthemessage“Outside Range Limit – Silence Alarm to Continue”appears.

3. Oncethealarmissilenced,themessage“Confirm Limit Override?”appears.

4. IfOverrideispressed,thevaluewillbeac-cepted.IfNoispressed,thevalueentryscreenreappears.

Hard limitsHardlimitsaretheabsolutemaximumandminimumforavalue.Whenattemptingtoenterorchangeanumericinfu-sionparameterofadrugprogramtheHardlimitsaredisplayedonscreenas“MAX:”and“MIN:”values.ItisnotpossibletoexceedaHardlimit.


20

Adjusted limits in reverseDuringsetup,thepumpdeterminesabsolutemini-mumsandmaximumsbasedonthephysicalabili-tiesofthepump,suchassyringesize(amongotherthings).(Seethetableonpage130forminimumandmaximumflowrates.)IfthePharmGuard™softwarelimitsareoutsideofthepumplimits,thepumpad-juststhelimitsasappropriate.Whenthisoccurs,thelimitpriorityalarm“Limits Adjusted—Cannot Deliver All Doses”issounded.Whenthepumpadjustslimits,theyarereversehighlighted.

Overridden limits in reverseWhenasoftlimitisoverridden,asdescribedin“SoftLimits,”above,theoverriddenvaluesaredisplayedinreversehighlight.

Invalid infusion parameter combinationThepumphasseveraltypesoflimits:physicallimits,thoseimposedbythesyringesizeinuse,anddrugprogramlimits.WhenthePharmGuard™softwarelimitsandthepumpphysicallimitscannotbereconciled,thealarm“Invalid Infusion Parameter Combination”or“Calculated Rate Out of Range”isdisplayed.Atthispoint,theonlypossiblecorrectiveactionistosilencethealarm,lookattheprompttodeterminewhichvaluesweretobeentered,pressâoneormoretimes,andattempttore-entervalidvalues.Anexampleofaninvalidinfusionparametercombinationisonewherethepumpphysicalmaximumislowerthanthesoftwareminimum,orvice-versa.Whenevera“Calculated Rate Out of Range”or,incer-taincasesofan“Invalid Infusion Parameter Combination”alarm,itispossiblethatthedrugprogramcreatedinPharmGuard®Toolbox2softwareissuchthatnovalidentryispossible,inwhichcaseyouwillneedtodocumenttheissueandrequestanupdateforcustomConfiguration.Itmaybeusefultocheckcalculationsusingacalcula-torandformulatohelpidentifyissueswithinvalidin-fusionparameters.Ifapumphasrecurringissuewithinvalidinfusionparameters,contacttheperson(s)responsibleforconfiguringpumps.

OPTIONS CLEAR TOTALS

PRESS < « > TO BEGIN INFUSION

CHG DOSEMAIN MENU

CONC 40 mg/mL PVD 0 mLWEIGHT 50 KG DOSE 495 MGTIME 01:00:00TIME REMAINING 01:00:00 RATE 12.4 mL/hr

Reversehighlight


21

PharmGuard™ Supported Syringes (PSS) Series 2Eachmanufacturedsyringehasuniquecharacteristics.Thesecharacteristicsdifferbymodelandsyringesize.TheMedfusion®Model4000pumpusesthespecificcharacteristicstoaccuratelydeliverfluid.IncludedwithPharmGuard®Toolbox2areseveralcommonlyusedMedfusion™StandardSyringesforafacilitytochoosefrom.ThesesyringesarechosenforuseinaConfigurationviaPharmGuard®Toolbox2.PharmGuard™SupportedSyringes(PSS)Series2al-lowtheadditionofawiderangeofavailablesyringemodelsandsizestoPharmGuard®Toolbox2,foruseincreatingDrugPrograms.PSSSeries2filesmustbeaddedviaPharmGuard®Toolbox2whencreatingacustomConfiguration.ContactSmithsMedicalforacompletelistofavailablePharmGuard™SupportedSyringes(PSS)Series2.(TheMedfusion™StandardSyringemodelsandsizesarelistedintheTechnicalInformationsectionofthismanualonpage130.)Specifictechnicalinforma-tion,includingsyringeflowrateandminimumvol-ume,isalsosuppliedintheliteratureaccompanyingPharmGuard®Toolbox2andthePharmGuard™SupportedSyringes(PSS)Series2.Refertowww.smiths-medical.comorcontactCustomerServiceformoreinformationaboutavailablePharmGuard™SupportedSyringes(PSS)Series2.

WARNING:OnlyusetheMedfusion™StandardSyringes(suppliedwithPharmGuard®Toolbox2,andincludedintheMedfusion™StandardConfiguration),orthemodelsandsizesavailableaspartofthePharmGuard™SupportedSyringes(PSS)Series2,andalwaysconfirmthatthesyringemodelandsizedisplayedonthepumpmatchesthemodelandsizeloadedintothepump.Useofunapprovedsyringesmaycauseimproperpumpoperationresultingininaccuratefluiddeliveryorocclusionsensingorotherpotentialhazards.


22

Navigating the pump menusTherearesomegeneralrulesfornavigatingpumpmenus.Mostofthepumpprogrammingstepsareaccomplishedbylookingtothedisplayscreen,andpressingthesoftkeykeysindicated.Forexample:

Thescreenshownaboveisanexampleofa“Begin Infusion”screen.Pressingsoftkey“1”openstheMainmenu;pressingsoftkey“2”initiatesthescreensforchangingthedosevalue;pressingsoftkey“3”openstheOptionsmenu;pressingsoftkey“4”clearstheinfusionvolumeanddosetotalsstoredinpumpmemory.Thesoftkeyschangefordifferentscreens,andsomescreenswillhaveonlycertainofthesoftkeysactive,orevennoactivesoftkeys.Alwayslooktothedisplaytoseewhatthesoftkeysareusedfor.Whenprogrammingavalueortoenteramenu,inmostcasesthenumberanddecimalkeysontherightsideofthekeypadareused.(Inmanycasesonceavalueisentered,youwillneedtopressasoftkeyto“Enter”orsavethevalueortoopenthemenu.)Somemenusareverylargeandtherewillbemoreitemstochoosefromthancanfitonasingledis-playscreen.Inthosecasesoneofthesoftkeyswillbe“More”,indicatingtherearemoreoptionsavailableandMorecanbepressedtoviewthem.Onthosesortsofmenus,oncetheendofthechoicesisreached,theMorekeybecomesBeginning,indicatingBeginningcanbepressedtogobacktothefirst“page”ofthemenu.Ifamistakeismadeinprogramming,oramenuopenedaccidentally,pressâtoreturntoaprevi-ousscreenormenu.

Legend

Inthismanual,menuinformationthatappearson-screenisshowninboldandsmallcapitals(forin-stance,Select the Profile).Textassociatedwithsoftkeysisshownasbold(forinstance,Enter).

The Workflow ProcessThebasicworkflowforprogramminganddeliveringaninfusionisshowninthediagramonthefollowingpage.Theinfusionmayconsistofseveraldistinctdeliver-ies,possiblyincludingaloadingdose,maininfusion,oneormorebolusesduringthemaininfusion,aswellasaflushorKVOinfusiononcethemaininfusioniscomplete.Itispossiblethatallofthesepartsareprogrammedintheinitialinfusionsetupsequence,ortheymayalsobeaddedatalatertime(aftertheinitialsetupbutbeforepressingÉtostarttheinfusion,orinsomecasesaftertheinfusionisstarted).Becausethepumphasmultiplecustomizablefea-tures,actualDrugProgramsandmanualinfusionmayhaveotherdeliveryoptionsandconfirmationscreensincludedthatarenotshowninthediagram.TheseadditionaloptionsandscreensaredependentonthecustomConfigurationcreatedinPharmGuard®Toolbox2.

G6000912 Rev 0

PRIME / BOLUS

MAIN MENU CLEAR TOTALS

PRESS < « > KEY TO BEGIN INFUSION

CHG DOSE OPTIONS

CONC 1000 mcg/mL PVD 0.000 mLWEIGHT 5 KG

DOSE 1 MCG/KG/MIN RATE 0.3 mL/hr


23

The Workflow Process

Select DrugProgram

Con�rmSyringe

Program Infusion Settings

Con�rm Settings

Pause

ProgramOptions

Setup

Connect toPatient

Deliver

Infuse

LoadingDoseProgram

Options

ChangeRate/Dose

BolusDose

InfusionComplete

SyringeEmpty

OR

Flush

KVO

Con�rmSyringe

Continue = YESContinue = NO

Optional Work�ow

Required Work�ow

Function-Dependent(Required)

KEY:

PrimePower On

Power O�

VolumeLimit Reached

OR

Start


24

Guidelines for enhanced pump performanceThefollowingareguidelinesforenhancedsyringepumpperformance.Reviewocclusiontimeandflowdeliverygraphs(startingonpage92).Useappropri-atesyringesize,tubing,andinlinedevicesforexpedit-ingdeliveryofmedicationorfluid.Certainfactorsenhancesyringepumpperformance,whereperfor-manceisdefinedas:

a) TimetoDetectOcclusionb) ContinuityofFlowc) StartupTime

Always use the smallest syringe for volume of fluid being deliveredWARNING:Usethesmallestsyringesizenecessarytodeliverthefluidormedication.Usingalargesyringeatverylowrates(belowMinimumRecommendedRateforthesyringe)maycauseimproperpumpoper-ation,delayedocclusionsensing,largerpostocclusionbolusathigherocclusionlimitsettings,deliveryinac-curacies,orotherpotentialhazards.Bolus Volume:Deliveringabolusvolumelessthentherecommendedbolusvolumeforthesyringeusedmayresultindeliv-eryinaccuracies.Useaninfusionsetwiththesmallestdiametertubingavailablethatdoesnotresultinexces-sivebackpressureatthedesiredflowrate.Considerpriming,loading,bolus,andflushrateswhenselectinganinfusionset.

Ifaccuracyisofprimeconcern,useonlysyringesthatmeetthe±2%requirementoftheISO7886-2Standard.Frictionandcomplianceofthesyringeplungertipaffectdeliverystartupandflowcontinuity.Thebiggerthesyringe,thegreaterthefrictionandcompliance,theslowerthestartup.Useasmallersyringewhenrunningatalowerrate.Thetablesonpage131showtherecommendminimumdeliveryratesforthestandardsyringes(includedwithPharmGuard®Toolbox2)bysyringesize.Similarin-formationisprovidedinthedocumentationsuppliedwithPharmGuard™SupportedSyringes(PSS)Series2.Whenprogrammingflowrates,alimitedpriorityalarmwillbeactivated,withanadvisorymessageon

thescreen,ifaratethatfallsoutsidethoserecom-mendedisentered.

Note:•FlowSentry™isnotavailableforallsyringesizesortypes.CheckthedocumentationthatcamewiththeMedfusion™StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2)and/orPSSSeries2forinformationontheavailabilityofFlowSentry™.•Ifaratebelowthatshownonthetablesonpage131orinthedocumentationsuppliedwiththePharmGuard™SupportedSyringes(PSS)Series2isentered,theRateBelowRecommendedMinforSyringeSizealarmwilloccur(seepage105forafullexplanationofthealarm).Theabsoluteminimumrateallowedbythepumpwithagivensyringeislistedinthetablesfoundonpage131,andincludedintheliteraturesuppliedwiththePharmGuard™SupportedSyringes(PSS)Series2.•Highviscosityfluidsmaycausefalseocclusionalarmsatlowerocclusionalarmsettings,particularlywithhigherratesofdelivery.Wheninfusinghigherviscosityfluids,adjusttheocclusionalarmsettingtominimizefalseocclusionalarms.


25

Bolus VolumeTherecommendedminimumbolusvolumeis1.0mLor10percentofthesyringevolumeofthesyringeused,whicheverisless.Inotherwords,fora1.0mLsyringe(regardlessoftheactualvolumeofmedica-tioncontained),theminimumrecommendedbolusvolumeis0.1mL.Fora60mLsyringe,therecom-mendedminimumbolusvolume(regardlessoftheac-tualvolumeofmedicationcontained),theminimumrecommendedbolusvolumeis1.0mL.Bolusvolumesdeliveredthatarelessthentherecommendedmini-mumbolusvolumesforthesyringeusedmayresultindeliveryinaccuracies.

Syringe Size Minimum Recommended Bolus Volume

1mL 0.1mL3mL 0.3mL5mL 0.5mL6mL 0.6mL10mL 1mL12mL 1mL20mL 1mL

30/35mL 1mL50mL 1mL60mL 1mL

Use appropriate internal diameter tubingForthemostconsistentlyprecisecontrolofallfluidsandmedications,itisrecommendedtouseappropri-ateinternal diameter tubing,aswellastominimize residual volumesbetweensyringeandpatientbyreducing:

a) Tubinginternaldiameter(generally,forratesunder5mL/hrsmallinternaldiametertubingisrecommended;forrates5mL/hrorabove,tubingwithalargerinternaldiametershouldbeusedtoreduceocclusionalarms)

b) Tubinglengthc) Sizeofin-linefiltersd) Numberofstopcocks

Thismakestheinfusionsetuplessvariableorcompli-ant,whichinturnreducesthestarttimeforfluidtoreachthepatient–andreducestimerequiredforde-tectinganocclusionandmaintainsdeliveryaccuracy.Useonlythestandardsyringesspecifiedonthetableonpage130andsuppliedwithPharmGuard®Toolbox2,orsuppliedwiththePharmGuard™SupportedSyringes(PSS)Series2(availablefromSmithsMedical).SmithsMedicalalsoprovidesavarietyofinfusionsetsthatcanbeusedwiththepump.Seewww.smiths-medical.comforinformationregardinginfusionsetsavailablefromSmithsMedical,orcontactyoursalesrepresentative.


26

Programming an InfusionTurn the pump onBelowrightisanillustrationofastartupscreen,andalistofbasicstepsforturningtheinfusionpumpon.

G6000912 Rev 0

PRIME / BOLUS1. Pressandholdëuntilthedisplayturnsdark.Verifythedisplayshowsallpixelson,thenallpixelsoff.

2. Thepump“beeps”twice,onelowbeepandonehighbeep.Thisisatestofthestandardaudiblealarmandthebatterybackupaudiblealarm(hightone).TheAlarm,Infusing,CommunicationandLockindicatorsflashastheself-testcyclesandthestartupscreenappears.TheDeviceID,ifithasone,appearsinthemiddleleftcorner.(Inthisexample,itiscalled“HOSPITAL”.)Thepumpserialnumberwillappearatthemiddleright(inthisexample,itis“M01234”).

3. Verifythedisplayindicatessuccessfulcompletionofsystemstartupself-tests.

If the pump does not turn on with successful completion of self-tests,removeitfromserviceandhaveitcheckedbyatrainedbiomedicaltechni-cian.

Note:The“Battery Not Working”alarmisnotfullyfunctionaluntilthesystemstartupself-testsandprocessesarecompleted,approximatelytwominutesafterturningthepumpon.

IMPORTANT:DonotmovetheSyringePlungerDriverorotherwisemanipulatethepumpuntilthestartuptestsarecompleteandtheProfileselectionscreenappears.Sensorsaretestedaspartofthestartupprocess,andmanipulatingthepumpdur-ingthisprocessmaycauseittodetectfalsesensorfailures,resultinginalarms.

VERIFYING CONFIGURATION

PHARMGUARD® MEDICATION SAFETYHOSPITAL VERSION V1.1.0 2000187CONFIG VERSION: 01.05.00002 CONFIG CRC: 4A4F

5 SECONDS REMAINING © 99-2010100%


27

Turning the pump offThepumpcanbeturnedoffatany time,inanydeliv-erymode,whilethepumpisrunning.

Note:Ifthereareanyalarmssounding,youmustfirstsilencethealarmbypressingíbeforethepumpcanbeturnedoff.

PRESS < POWER > AGAIN TO SHUTDOWN

CONC 1000 mcg/mL PDD 1.27 mLWEIGHT 5 KG

DOSE 1 MCG/KG/MIN RATE 0.3 mL/hrCONTINUE

N

With the pump infusing:1. Pressand holdë.

ThePress Power Again to Shutdownscreenappears.Infusion has not stopped at this point.(Ifëisnotpressedagain,poweroffiscancelledafter6minutes.)

2. Pressand holdëagaintoturnthepumpoff.TocancelpressContinueorâ.

Infusionstopswhenthepumpisturnedoff.With the pump stopped:

1. Pressandholdë.Thepumpturnsoff.

Note:IfthereareanyConfigurationorsoftwareupdateswaitingtobeinstalledinthepump,the“Update(s) Available”messageisdisplayedwhenyouattempttoturnthepumpoff.Seepage110.

G6000912 Rev 0

PRIME / BOLUS

LOCK

CONC 1000 mcg/mL PVD 0.05WEIGHT 5 KG

DOSE 1 MCG/KG/MIN RATE 0.3

SHUTDOWN IN PROGRESS

CONC 1000 mcg/mL PDD 1.27 mLWEIGHT 5 KG

DOSE 1 MCG/KG/MIN RATE 0.3 mL/hrCONTINUE

N

DOBUTamine 0.5 mg/mL


28

Selecting a Delivery Mode and Programming an infusionDuetothecustomizationcapabilitiesoftheMedfusion®Model4000pump,thescreenshownoncepower-upiscompletedependsentirelyonwhat,ifany,customizationwasperformed.TypicallyaCustomConfigurationwillhavebeencre-atedusingPharmGuard®Toolbox2,andhavebeensenttothepump.IfaConfigurationwithProfileswassenttothepump,thepumpwillstopatthe“Select the Profile”Mainmenu.IfnoCustomConfigurationwassenttothepump,thepumpwillstopatthe“Medfusion™StandardConfiguration”Mainmenu.IftheCustomConfigurationsenttothepumpconsistsofonlyoneprofilecontainingaQuicklibrary,thepumpstopsattheQuicklibrarymenu.Thegraphiconthefollowingpageshowsthegeneralstepsrequiredtoprogramandstartaninfusion.Specificinstructionforprogrammingthevarioussettings,deliverymodesandoptionsfollows.


29

PRESS THE NUMBER TO SELECT

MORE

1 mL/hr 5 RECALL LAST SETTINGS2 VOLUME/TIME3 DOSE/TIME4 DOSE / KG / TIME

General Infusion Programming Procedure

Select a Profile

Load desired syringe (may also be done when it comes up in the programming process)

Select a Category or manual delivery mode

Custom Configuration: Medfusion™ Standard Configuration:

Select a Drug Program Select a manual delivery mode

Select a Syringe Model/Size

[If not done previously, load desired syringe] Verify model and size

Program required infusion parameters as they appear in programming process

If desired (and if available), program desired Options

Prime infusion set and pump

Start infusion


MORE



PAGE


PREV NEXT

MORECHG PROFILE




30

Selecting an InfusionFollowingarethestepsforselectinganinfusiontypeforprogramminganinfusion.TheProfiles,CategoriesorDeliveryModes,anddrugprogramsavailableonapumparedependentonhowthepumpwasconfigured,andwhetheracustomConfigurationwascreatedusingthePharmGuard®Toolbox2 (performedbywhomeverisresponsibleforcustomizingthepumpbeforeitwasdeliveredtoaworkarea).Theactualscreensonthepumpmaylookverydifferentfromthoseshownhere.Aftersuccessfullycompletingitssystemstartupself-tests,thepumpdisplaysoneofthefollowingmenus(dependingonthepump’sconfiguration).


31

Select a Profile (Custom Configuration)Aftersuccessfullycompletingitssystemstartupself-tests,apumpwithaCustomConfigurationwithmultipleprofilesdefinedwilldisplaySelect The Profile.Pumpscanbeconfiguredsothatallorsomeoftheprofilesrequireapasscodetoaccessthem.Ifthatisthecase,theappropriatepasscodemustbeenteredtoaccesstheprofile.

Note:IfonlyasingleProfilewassetupforuseonthepump(usingPharmGuard®Toolbox2),noneofthesescreenswillappear.Thepumpwillinsteaddisplaythedrugcategoryselectionscreenfollowingsuccessfulsystemstartupself-tests.

• Theconfigurationprofiles,categoriesanddrugprogramsavailableonthefollowingscreensaredependentonwhichweresetupinthecustomConfiguration.Theactualscreenonthepumpmaylookverydifferentfromtheonesshownhere.

1. Pressanynumberkeytoselectthedesiredprofile.Ifamistakeismade,pressâtoreturntotheSelect the Profilescreen.

2. Ifthedesiredprofileisnotdisplayed,pressMoretodisplaythenextpageofprofiles.

Either:a) Selectaprofilebypressingitsnumber

andcontinuetheprogrammingprocess.OR

b) PressBeginningtoreturntothefirstpageoftheSelect the Profilescreen.

3. Ifrequired,entertheprofilepasscode,thenpressEnter.

BACKSPACE ENTER

ENTER PROFILE PASSCODE - PRESS ENTER TO CONTINUE

MAX: 9999

MIN: 1000

CLEAR


MORE



MORE

1 mri/radioLogy2 code drUgS


32

Select a Category4. Onceinsideaprofile,selectacategory

bypressingitsnumber.Ifacategorycannotbefound,pressCHG ProfiletoreturntotheSelect the Profilemenu.EachProfilecanhaveamaximumof8Categorieswithupto36DrugProgramseach,resultinginamaximumof288entriesperProfile.Theactualnumberofdrugprogramsisdependentonthecontentofeachdrugprogramandontheamountofavailablepumpmemory.

“Quick” Librarya. IftheProfileselectedincludesa“Quick”

Library,theQuickLibrary'sdrugprogramselectionscreendisplays.

b. Selectadrugprogrambypressingitsnumber.(IfQuickLibrarydrugprogramsarenotdesired,pressMain MenutoexittheQuicklibraryanddisplaythecategorychoicesforfurtherdrugprogramselections.)Item4,above,appliestoQuickLibraryaswell.

c. ThefarleftsoftkeycanbepressedtoaccesstheQuickLibrary.ThekeywillreflecttheactualnameassignedtotheQuickLibraryintheConfiguration(Quick Libraryisonlyanexample).

Select a Drug Program5. SelectaDrugProgrambypressingits

number.Notethenumberofpagesinthecategoryisdisplayed,alongwiththecurrentpage(inthisexample,1/8).Ifthedesireddrugprogramisnotdisplayed(andprovidedthecategorycontainsmoredrugprograms),pressNext(or,ifyouknowthepagenumberofthedrugprogramyouwant,pressPagethenusethenumberkeyforthepage).Oncepastpage1ofthecategory,pressPrevtomovebackapage.

MORECHG PROFILE




MAIN MENU


MORE

1 Anesthesia A-D 5 Anesthesia Q-Z2 Anesthesia E-I3 Anesthesia J-M4 Anesthesia N-P

CHG PROFILE

PRESS THE NUMBER TO SELECT aneStheSia

QUICK LIBRARY


PAGE


PREV NEXT


33

DEXAmethaSone 4 mg/mL

CONFIRM DRUG PROGRAM SELECTION? HEM/ONC

NOYES


MORE

1 mL/hr 5 RECALL LAST SETTINGS2 VOLUME/TIME3 ROSE/TIME4 DOSE / KG / TIME

Thepumprequiresaconfirmationfordrugpro-gramselections;pressYestoconfirmtheselection,orpressNotoreturntotheSelect screen.

If“manual”modesareavailableinthecustomConfigurationandselectedforaninfusion,thepumppromptsforaconfirmationaswell.PressYestoconfirmtheselection,orpressNotoreturntotheSelectscreen.Afteradrugprogramselectionismadethepumpwillpromptyoutoselectthesyringemodelandsizebeforeprogrammingtheselectedmode(seepage34).Specificinformationforprogrammingthevari-ousdeliverytypesfollowstheinstructionsforthesyringe.

Select a Delivery Mode (Medfusion™ Standard Configuration)

1 Ifthepumpdoesnothaveacustomconfiguration,theMedfusion™StandardConfigurationmenudisplays.

2. Selectadeliverymodebypressingitsnumber.Ifthedesiredmodeisnotdisplayed,pressMoretodisplayadditionaldeliverymodes(ifpresent).

3. Thepumprequiresconfirmationofmanualmodeselection.PressYestoconfirmtheselection,orpressNotoreturntotheSelect screen.

Afteradeliverymodeselectionismadethepumpwillpromptyoutoselectthesyringemodelandsizebeforeprogrammingtheselectedmode(seepage34).Specificinformationforprogrammingthevari-ousdeliverytypesfollowstheinstructionsforthesyringe.

mL / hr

CONFIRM MANUAL PROGRAMMING / DELIVERY MODE?

NOYES

mL / hr

CONFIRM MANUAL PROGRAMMING / DELIVERY MODE?

NOYES


34

Loading a syringe and syringe model setupOnceaDrugProgramormanualdeliverymodehasbeenchosen,specifythesyringemodelandsize,andloadthesyringe.Pumpscanbecustomizedtoallowforuseofawidevarietyofsyringebrandsandsizes,orcanlimittoasfewasasinglesyringebrand.If a pump has been customized to a single syringe brand, none of the following screens will appear.Syringesetupandloadingisamulti-stepprocess,basedonyourdailypracticeofinfusingpatientswithmedicationsorotherfluids.Useyourfacility'sstandardprotocolforpreparinganinfusion.


SELECT SYRINGE MODEL1 B-D2 MONOJECT3 TERUMO

CONFIRM

CONFIRM SYRINGE MODEL / SIZE / LOADING

B-D

¤

≤™

Note:Pharmacylabelsplacedonthesyringemayinterferewiththepump’ssyringesensors.Toavoidinterference,placepharmacylabelsatleast1inchfromtheflange(sothattheSyringeBarrelClampdoesnotrestonalabel),andorientthesyringesothelabelfacesupwardanddoesnotrestonthepump.

IMPORTANT:DonotmovetheSyringePlungerDriverorotherwisemanipulatethepumpuntilthestartuptestsarecompleteandtheProfileselec-tionscreenappears.Sensorsaretestedaspartofthestartupprocess,andmanipulatingthepumpduringthisprocessmaycauseittodetectfalsesensorfailures,resultinginalarms.

1. Inspectthesyringetoidentifythemodelandsize.

2. Pressanumberkeytoselectthesyringemodelbeingused.

Note:If,whenthepumpwaspoweredup,thesy-ringebarrelclampwaspulledupandrestingonthepumphandle,aCheck Syringe Barrel Clampalarmmayoccurimmediatelyuponselectingasyringemodel(manufacturer).Pressítosilencethealarm,pressConfirm,thencontinuewiththeseinstructionsforloadingasyringe.

3. Itisnowtimetoloadthesyringe.(Thearrowsshownonscreenindicatethatthesyringesensorsdetectthatthesyringeisnotloaded.)


35

4. LiftupwardontheSyringeBarrelClampandturnitsoitisoutoftheway.

5. SqueezethePlungerReleaseLeveronthesyringeplungerdriverandpullgentlytoextenditallthewayoutward.

WARNING: Verifythattheplungerholderssecure-lycapturethesyringeplunger.Makesuretocapturethesyringebarrelandflange.Failuretoproperlysecurethesyringecouldresultinuncontrolledfluidflowtothepatient,whichcouldresultinseriousinjuryordeath.

6. Loadthesyringeontothepumpasillustrated,makingsuretheflangeofthesyringebarrelispressedorrolledintotheFlangeClip.


36

7. SqueezethePlungerReleaseLeveronthesyringeplungerdriverandpushittowardthesyringeplunger;onceitisflushwiththesyringeplungerreleasethelever.Besurebothholdersclosearoundthesyringeplunger.

8. TurnandlowertheBarrelClampontothebarrelofthesyringe.

WARNINGS:•Verifythattheplungerholderssecurelycapturethesyringeplunger.Makesuretocapturethesy-ringebarrelandflange.Failuretoproperlysecurethesyringecouldresultinuncontrolledfluidflowtothepatient,whichcouldresultinseriousinjuryordeath.•AlwaysusethePrimefunctiononthepumpwhenloadinganewsyringeinordertoremoveanyme-chanicalslack.FailuretoprimecorrectlycandelayinfusiondeliveryandcauseTotalVolumeDeliveredtoreadhigherthanwhatisactuallydeliveredtothepatient.

Thesizeshouldnowappearinthedisplay.

Note:Ifthesyringeisincorrectlyloaded,guidear-rowsappearonscreentoidentifytheproblem.

CONFIRM

CONFIRM SYRINGE MODEL / SIZE/ LOADING

B-D 60mL

CONFIRM

CONFIRM SYRINGE MODEL / SIZE/ LOADING

B-D

¤

≤™

Arrow pointing down “™“ means check syringe barrel clamp. Arrow pointing left “≤“ means check syringe plunger holders. Arrow pointing up “¤” means check syringe flange clip.


37

Note:Somesyringesmayhavesimilarouterdimen-sions,despitebeingdifferentsizes(forexample,BD®1mLLuerLok™and3mLsyringes),orevendifferentmodels.Inthesecases,thepumpwilldisplayop-tions,requiringyoutoselectthecorrectsyringesizeactuallyinuse.Alwaysverifythatthesyringemodelshowniswhatyouareactuallyusing.

9. Makesurethepumpcorrectlyrecognizesthesyringesize,andthesyringemodeliscorrect.Ifnot,verifythatthemodelandsizeareavailableonthepump(contactthepersonwithinthefacilityresponsibleforcustomizingthepumpformoreinformation,ifnecessary).


10.ThreadthetubingthroughthethreeTubingHoldersonthetopleftsideofthepump.

WARNING: Periodicallycheckthefluidpathwayandallconnections(includingthecatheter/admin-istrationsetconnection)forleaks.Leaksinthesys-temmaycausefluidlossresultinginunder-delivery,aswellasallowinganopeningforcontamination.

11.PressConfirm toconfirmthesyringeinformation.

Thepumpwillnowautomaticallydisplaythepro-grammingscreensforthedeliverymodechosen.Sincetherearemanymodestochoosefrom,inwhichawidevarietyoffunctionswithinthatmodemayormaynothavebeenenabled,whatfollowsisanexplanationoftheprogrammingstepsrequiredforeachpossibledeliverymodewithallfunctionsenabled.

1mL LL

SELECT THE SYRINGE

B-D

™

3mL

CONFIRM SYRINGE MODE / SIZE / LOADING

b-d 1mL LL

conFirm


38

Unloading the syringe

WARNING:Turn off fluid flow.Alwaysturnofffluidflowtopatientintubingviaclamporstopcockbeforeloadingorunloadingasyringe.Uncontrolledfluidflowcanoccurwheninfusionsetisnotclampedorturnedoffresultingininappropriatedeliveryrate,andmaycauseseriousinjuryand/ordeath.

Unloadasyringeexactlytheoppositewayasitwasloaded.Justusethefollowingsteps:

1. Pressátostopdelivery.2. Clamporcloseinfusionlinefromthe

syringetopatient.3. UnthreadthetubingfromtheTubing

Holdersonthetopleftsideofthepump.4. LiftandswivelthesyringeBarrelClampout

oftheway.5. SqueezethePlungerReleaseLeveronthe

syringeplungerandremovethesyringe.


39

Programming InfusionsContinuous mode: mL/hrContinuousinfusionisprogrammedbysettingaflow rate in mL/hr.Actualrangelimitsforflowratearedeterminedbysyringemodelandsize(seethetableinTechnicalsection(page130)ofthismanualand/ortheproductliteraturesuppliedwithPharmGuard®Toolbox2orthePharmGuard™SupportedSyringes[PSS]Series2)orbyacustomconfiguredmaximumrate.Ifneeded,andiftheoptionshavebeenenabledusingPharmGuard®Toolbox2,avolumelimit,load-ingdose,orbolusdosecanalsobeprogrammed.

ToprogramaContinuousmodeinfusion,attheselec-tionmenu,chooseml/hr(orchooseadrugprogramthatusesthecontinuousmodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.

1. Usethenumberkeysand(ifneeded)thedecimalpointtosettheflowrate.PressClear toclearanentry.PressBackspacetoeraseacharacter.PresstheEnter keytoacceptthesetting.

2. Afterallinfusionvaluesareset,thepumppausesattheBegin Infusionscreen(thepumpmaybeconfiguredwithadditionalconfirmationscreens,requiringyoutoconfirmallsettingstwicebeforebeginningtheinfusion).

3. Ifdesired,programaBolusDose,LoadingDoseorVolumeLimit(seeOptions,page61).

4. Priortoconnectingtothepatient,pressètoinitiatetheprimingsequence(page59).

5. Confirmthesettingsandstarttheinfusion,orusethefourmenukeystomodifythesettings.


6. Whenalldeliverysettingsareconfirmedascorrect,pressÉtobegintheinfusion.

BACKSPACE ENTER

ENTER RATE - PRESS ENTER TO CONTINUE

HIGH: 944

LOW: 0.1

CLEAR

mL / hr50



CHG RATEMAIN MENU

PVD 0 mL

RATE 50 mL/hr

Main Menu – returns to the Main Menu. Chg Rate – allows modifying the set rate. Options – selection from a list of variables (e.g., bolus, volume limit, etc.). Clear Totals – clears total volume delivered, and PVD or PDD.


40

Dose / Min and Dose / HrTheDose/Minand/orDose/Hrmodesmaybeavail-ableonapump.Programthembysetting:

• Drug concentration units(i.e.,g/mL,mg/mL,mcg/mL,mMol/mL,mEq/mL,orUnits/mL)

• Drug concentration• Drug delivery units (e.g.,g,mg,mcg,ng,

mMol,mEq,orUnits)• Dose rate

• Volume limit, KVO, loading dose, or bolus dose may also be programmed (these options are only available if they have been enabled in the profile or specified in the Drug Program using PharmGuard® Toolbox 2)

Attheselectionmenu,chooseeitherDose/MinorDose/hr(orchooseadrugprogramthatusesthein-fusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.

1. Usethenumberkeystoselectthemedicationconcentrationunits.(Theactualunitsavailableonapumpdependsonthecustomsetup.)PressEntertoacceptthemedicationconcentrationunits.

2. Usethenumberkeystosetmedicationconcentration.Concentrationislimitedto4digits.PressClear toclearanentry.PressBackspacetoeraseacharacter.PresstheEnter keytoacceptthesetting.

3. Usethenumberkeystosetthedeliveryunits.(Theactualunitsavailableonapumpdependsonthecustomsetup.)If only one delivery unit is available for the concentration units selected, this screen will not appear.PressEntertoacceptthedeliveryunits.

4. Usethenumberkeystosetdoserate.Rangelimitsfordoseratearedeterminedbysyringesizeand/orthecustomsetupintheConfiguration.Thehighandlowratelimitsdisplayonscreen.Whenthedoseiscorrect,pressEnter.

5. AttheBegin Infusionscreenallvaluesaresetandthepumppauses(thepumpmaybeconfiguredwithadditionalconfirmationscreens,requiringyoutoconfirmallsettingstwicebeforebeginningtheinfusion).

PRESS THE NUMBER TO SELECT THE CONCENTRATION UNITS

1 GRAMS 5 MILLIEQUIVALENTS2 MG 6 MILLIMOLES3 MCG4 UNITS

BACKSPACE ENTER

ENTER CONCENTRATION - PRESS ENTER TO CONTINUE

HIGH: 9999

LOW: 0.0001

CLEAR

mg / mL0.6

PRESS THE NUMBER TO SELECT THE DELIVERY UNITS

1 MG2 MCG

BACKSPACE ENTER

ENTER DOSE RATE - PRESS ENTER TO CONTINUE

HIGH: 8732

LOW: 0.925

CLEAR

MCG / MIN1.5


41



CHG DOSEMAIN MENU

CONC 0.6 mg/mL PVD 0 mL

DOSE 1.5 MCG/MIN RATE 0.15 mL/hr

Main Menu – returns to the Main Menu. Chg Dose – allows modifying the set dosage without starting from scratch. Options – allows selection from a list of variables (e.g., bolus, volume limit, etc.). Clear Totals – clears total volume delivered, and PVD or PDD.

6. Confirmthesettingsandstarttheinfusion,orusethefourmenukeysshownatrighttomodifythesettings.




9. Whenalldeliverysettingsareconfirmedascorrect,pressÉtobegininfusion.


42



BACKSPACE ENTER


HIGH: 9999

LOW: 0.0001

CLEAR

mg / mL0.9


1 MG2 MCG

BACKSPACE ENTER


HIGH: 8732

LOW: 2.16

CLEAR

MG / DAY5


Dose / DayTheDose/Daymodemaybeavailableonapump.ProgramDose/Daybysetting:



mMol,mEq,orUnits)• Dose rate

• Volume limit, KVO, loading dose, or bolus dose may also be programmed (these options are only available if they have been enabled in the profile or specified in the Drug Program using PharmGuard® Toolbox 2)

Attheselectionmenu,chooseDose/Day(orchooseadrugprogramthatusestheinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.




4. Usethenumberkeystosetdoserate.Rangelimitsfordoseratearedeterminedbysyringesizeand/orthecustomsetupintheConfiguration.Thehighandlowratelimitsdisplayonscreen.Whenthedoseiscorrect,pressEnter.





CHG DOSEMAIN MENU

CONC 0.9 mcg/mL PVD 0 mL

DOSE 5 MCG/DAY RATE 0.232 mL/hr


43






44



BACKSPACE ENTER


HIGH: 9999

LOW: 0.0001

CLEAR

mg / mL0.6


1 MG2 MCG

BACKSPACE ENTER

ENTER DOSE - PRESS ENTER TO CONTINUE

HIGH: 300

LOW: 0.003

CLEAR

MG5

BACKSPACE ENTER

ENTER DELIVERY TIME

HIGH: 24:00:00

LOW: 00:06:00

CLEAR

:0002:15H R : M I N : S E C

Dose / TimeTheDose/Timemodemaybeavailableonapump.ProgramDose/Timebysetting:



mMol,mEq,orUnits)

• Dose rate• Delivery Time

Attheselectionmenu,chooseDose/Time(orchooseadrugprogramthatusestheinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.




4. Usethenumberkeystosetdose.Rangelimitsfordosearedeterminedbysyringesizeand/orthecustomsetupintheConfiguration.Thehighandlowdoselimitsdisplayonscreen.Whenthedoseiscorrect,pressEnter.

5. Thetimesettingscreenappears.Pressthenumberkeystosetthetimeinhoursandminutes,thenpressEnter.



45



MAIN MENU

CONC 0.6 mg/mL PVD 0 mL DOSE 5 MGTIME 02:15:00TIME REMAINING 02:15:00 RATE 3.7 mL/hr

Main Menu – returns to the Main Menu. Options – allows selection from a list of variables (e.g., bolus, volume limit, etc.). Clear Totals – clears total volume delivered, and PVD or PDD.

7. Confirmthesettingsandstarttheinfusion,orusethethreemenukeysshownatrighttomodifythesettings.


9. Ifdesired,LoadingDoseorVolumeLimit(seeOptions,page61).


10.Whenalldeliverysettingsareconfirmedascorrect,pressÉtobegininfusion.


46

Body weight/surface area infusion deliveriesThefollowingBodyweight/surfacearea-basedinfu-siondeliverymodesmaybeavailableonapump:dose/kg/min(dose/m2/min)−dose/kg/hr(dose/m2/hr)–dose/kg/day(dose/m2/day).Thebodyweight/surfacearearatecalculationallowsprogrammingby:


• Drug concentration• Drug delivery units(i.e.,g,mg,mcg,ng,mMol,

mEq,orUnits)• Patient’s weight/Body surface area• Dose

• Volume limit, KVO, loading dose, or bolus dose may also be programmed (these options are only available if they have been enabled in the custom program using PharmGuard® Toolbox 2)

ThepumpcalculatesthecorrectflowrateinmL/hrtoachievetherequireddrugdose.Toprogramabodyweight/surfaceareainfusion,attheselectionmenu,chooseeitherDose/Kg/Min (Dose/M2/Min),Dose/Kg/hr (Dose/M2/Hr)orDose/Kg/Day (Dose/M2/Day)(orchooseadrugprogramthatusesthebodyweight/surfaceareamodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasin-structedonpage34.

1. Pressthenumberkeystosetthemedicationconcentrationunits.(Theactualunitsavailableonapumpdependsonthecustomsetup.)PressEntertoacceptthemedicationconcentrationunits.

2. Pressthenumberkeystosetmedicationconcentration.Concentrationislimitedto4digits.PressClear toclearanentry.PressBackspacetoeraseacharacter.PressEnter toacceptthesetting.


4. Pressthenumberkeystosetthepatient’sweightinkilogramsorsurfaceareainsquaremeters.Weight/surfaceareaarelimitedtotheindicatedrange(whichmayhavebeencustomized).PressEntertoacceptthepatientweight/surfaceareasetting.


1 GRAMS 5 MILLIEQUIVALENTS2 MG 6 MILLIMOLS3 MCG4 UNITS

BACKSPACE ENTER


HIGH: 20

LOW: 0.001

CLEAR

mg / mL0.25


1 MG2 MCG

BACKSPACE ENTER

ENTER PATIENT WEIGHT - PRESS ENTER TO CONTINUE

HIGH: 250

LOW: 0.25

CLEAR

KG10


47

Thepumpmaybecustomizedwithanadditionalpatientweight/bodysurfaceareaconfirmationscreen.Ifso,re-enterthepatientweight/bodysurfacearea,thenpressEntertoacceptthesetting.

5. AttheDose Ratescreen,pressthenumberkeystosetthedose.Rangelimitsaredeterminedbyinstalledsyringesizeand/orthecustomsetupintheConfiguration.WhenthesettingiscorrectpressEntertoacceptthedose.

6. Ifdesired(andiftheyareenabled),programaBolusDose,LoadingDoseorVolumeLimit(seeOptions,page61).





10.Whenalldeliverysettingsareconfirmedascorrect,pressÉtobegininfusion.

BACKSPACE ENTER

RE-ENTER PATIENT WEIGHT - PRESS ENTER TO CONTINUE

HIGH: 250

LOW: 0.25

CLEAR

KG

BACKSPACE ENTER


HIGH: 0.2012

LOW: 0.0001

CLEAR

MCG / KG / HR0.2



CHG DOSEMAIN MENU

CONC 0.25 mg/mL PVD 0 mLWEIGHT 10 kg

DOSE 0.2 mg/kg/hr RATE 8 mL/hr



48

Volume / weight infusionsThefollowingvolume/weightmodesmaybeavailableonapump:mL/kg/minandmL/kg/hr.Volume/weightinfusionsratecalculationsallowpro-grammingby:

• Patient’s weight• Volume of drug per kilogram of weight• Volume limit, KVO, loading dose, or bolus

dose may also be programmed (these options are only available if they have been enabled in the custom program using PharmGuard® Toolbox 2)

ThepumpcalculatesthecorrectflowrateinmL/hrtoachievetherequireddrugdose.Toprogramavol-ume/weightinfusion,attheselectionmenu,chooseeithermL/Kg/MinormL/Kg/Hr(orchooseadrugprogramthatusesthevolume/weightmodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.

1. Usethenumberkeystosetthepatient’sweightinkilograms.Weightislimitedtotheindicatedrange.PressEntertoacceptthepatientweightsetting.

Thepumpmaybecustomizedwithanadditionalpatientweight/bodysurfaceareaconfirmationscreen.Re-enterthepatientweight,thenpressEntertoacceptthesetting.

2. AttheVolume/Kilogramscreen,pressthenumberkeystosetthevolumeperweightsetting.Rangelimitsaredeterminedbytheinstalledsyringesize,patientweight,and/orthecustomsetupintheConfiguration.WhenthesettingiscorrectpressEntertoacceptit.

3. Ifdesired(andiftheyareenabled),programaBolusDose,LoadingDoseorVolumeLimit(seeOptions,page61).



BACKSPACE ENTER


HIGH: 250

LOW: 0.25

CLEAR

KG5

BACKSPACE ENTER


HIGH: 250

LOW: 0.25

CLEAR

KG

BACKSPACE ENTER

ENTER VOLUME / KILOGRAM - PRESS ENTER TO CONTINUE

HIGH: 0.3267

LOW: 0.0002

CLEAR

mL / kg / hr0.3


49






CHG DOSEMAIN MENU

PVD 0 mLWEIGHT 5 KG

DOSE 0.3 mL/kg/hr RATE 1.5 mL/hr



50

Dose/kg/time (dose/m2/time)Thebodyweight/surfaceareainfusiondeliverymodewill only be available on your pumpthroughcustomprogrammingviaPharmGuard®Toolbox2.OnceconfiguredonthePharmGuard®Toolbox2,taughttoaMedfusion®Model4000pump,andonceadrughasbeenselectedfromthelibrary,entriesonthepumpmayberequiredforthefollowing:

• Drug selection only• Drug concentration (NOTE: Ifpresetlimits

wereprogrammedinPharmGuard®Toolbox2,thisoptionwillbeavailable.Ifa preset valuewasprogrammedinPharmGuard®Toolbox2,theconcentrationlimitsarenotneeded.)

• Patient’s weight/Body surface area• Dose• Delivery time

ThepumpcalculatesthecorrectflowrateinmL/hrtoachievetherequireddrugdose.Thepatientweight/bodysurfaceareaisusedtocalculatedoselimits.Toprogramabodyweight/surfaceareainfusion,chooseaDrugProgramwithDose/Kg/Time(Dose/m2/Time).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.Thefollowingprocedureisanexampleofhowaninfusionmightbeprogrammed.Theactualproceduredependsonhowtheinfusionwasinitiallycustomized.

1. Pressthenumberkeystosetmedicationconcentration.Concentrationislimitedto4digits.PressClear toclearanentry.PressBackspacetoeraseacharacter.PressEnter toacceptthesetting.

2. Pressthenumberkeystosetthepatient’sweightinkilogramsorsurfaceareainsquaremeters.Weight/surfaceareaarelimitedtotheindicatedrange.PressEntertoacceptthepatientweight/surfaceareasetting.

Thepumpmaybecustomizedwithanadditionalpatientweight/bodysurfaceareaconfirmationscreen.Ifso,re-enterthepatientweight/bodysurfacearea,thenpressEntertoacceptthesetting.

3. AttheDosescreen,pressthenumberkeystosetthedose.Doselimitsdisplayedaredependantoncustomsettingsandinstalledsyringesize.WhenthesettingiscorrectpressEntertoacceptthedose.(ThepumpcalculatesthecorrectflowrateinmL/hrtoachievetherequireddrugdose.)


BACKSPACE ENTER


HIGH: 10

LOW: 2

CLEAR

mg / mL

BACKSPACE ENTER


HIGH: 8

LOW: 0.25

CLEAR

KG

BACKSPACE ENTER

ENTER DOSE - PRESS ENTER TO CONTINUE

HIGH: 2500

LOW: 0.083

CLEAR

GRAM

BACKSPACE ENTER

ENTER DELIVERY TIME

HIGH: 08:00:00

LOW: 00:01:00

CLEAR

:0000:01H R : M I N : S E C

BACKSPACE ENTER


HIGH: 250

LOW: 0.25

CLEAR

KG


51



7. Confirmthesettingsandstarttheinfusion,orusethemenukeysshownatrighttomodifythesettings.



MAIN MENU

CONC 7 mg/mL TVD 0 mLWEIGHT 1 KG DOSE 2 MGTIME 00:01:00TIME REMAINING 00:01:00 RATE 0.286 mL/hr

OPTIONS CLEAR TVD

acycLovir (Zovirax)(kg doSing) GENERAL PEDS

Main Menu – returns to the Main Menu. Options – allows selection from a list of variables (e.g., bolus, volume limit. etc.). Clear TVD – clears total volume delivered.


52

Volume / weight / timeThevolume/weight/timedeliverymode(mL/kg/Time)maybeavailableonapump.Volume/weight/timeinfusionratecalculationsallowprogrammingby:

• Patient’s weight• Volume of drug per kilogram of weight• Delivery time

ThepumpcalculatesthecorrectflowrateinmL/hrtoachievetherequireddrugdose.Toprogramavolume/weight/timeinfusion,attheselectionmenu,choosemL/Kg/Time(orchooseadrugprogramthatusesthevolume/weight/timemodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasin-structedonpage34.

1. Usethenumberkeystosetthepatient’sweightinkilograms.Weightislimitedtotheindicatedrange.PressEntertoacceptthepatientweightsetting.

Thepumpmaybecustomizedwithanadditionalpatientweightconfirmationscreen.Ifso,re-enterthepatientweight,thenpressEntertoacceptthesetting.

2. AttheVolume/Kilogramscreen,pressthenumberkeystosetthevolumeperweightsetting.Rangelimitsherearedeterminedbytheinstalledsyringesize,patientweightand/orthecustomsetupintheConfiguration.WhenthesettingiscorrectpressEntertoacceptit.




BACKSPACE ENTER


HIGH: 8

LOW: 0.25

CLEAR

KG5

BACKSPACE ENTER


HIGH: 12

LOW: 0.25

CLEAR

KG

BACKSPACE ENTER

ENTER VOLUME / KILOGRAM - PRESS ENTER TO CONTINUE

HIGH: 20

LOW: 10

CLEAR

mL / kg15

BACKSPACE ENTER

ENTER DELIVERY TIME

MAX: 01:00:00

MIN: 00:10:00

CLEAR

:0000:30H R : M I N : S E C


53

Main Menu – returns to the Main Menu. Options – allows selection from a list of variables (e.g., bolus, volume limit, etc.). Clear TVD – clears total volume delivered.

OPTIONS CLEAR TVD


MAIN MENU

PVD 0 mLWEIGHT 5 KG VTBI 15 mL/kgTIME: 00:30:00TIME REMAINING 00:30:00 RATE 150 mL/hr

6. Confirmthesettingsandstarttheinfusion,orusethemenukeysshownatrighttomodifythesettings.




54

Volume / timeThevolumeovertimeratecalculationallowspro-grammingby:

• Dose Volume• Delivery Time

Thepumpcalculatesthecorrectflowratebydividingthevolumebythedeliverytime.Volumelimit,load-

ingorbolusdosecannotbesetinthismode.ToprogramVolume/Time,chooseitattheselectionmenu(orchooseadrugprogramthatusesthevol-ume/timemodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.

1. Pressthenumberkeystoprogramthevolumetoinfuse.Volumeislimitedto500mL–andminimumvolumeis1/600thoftheselectedsyringesize.WhentheVolumesettingiscorrect,pressEnter.

Note:Volumeislimitedto500mLregardlessofsyringesizeinuse,assomeinfusionsmayrequiremultiplesyringes.

2. Pressthenumberkeystosetdeliverytime.Timeisalwayslimitedbymaximumandminimumratesforselectedsyringesizeand/orthecustomsetupintheConfiguration.Whenthedeliverytimeiscorrect,pressEnter.



5. Confirmthesettingsandstarttheinfusion,orusethethreemenukeystomodifythesettings.



BACKSPACE ENTER

ENTER VOLUME TO INFUSE - PRESS ENTER TO CONTINUE

HIGH: 500

LOW: 0.005

CLEAR

mL50

BACKSPACE ENTER

ENTER DELIVERY TIME

HIGH: 24:00:00

LOW: 00:31:00

CLEAR

:0000:40H R : M I N : S E C

OPTIONS CLEAR TVD


MAIN MENU

VOLUME 50 mL TVD 0 mLTIME 00:40:00

TIME REMAINING 00:40:00 RATE 75 mL/hr

Main Menu – returns to the Main Menu. Options – allows selection from a list of variables (e.g., standby, etc.). Clear TVD – clears total volume delivered.


55

Intermittent volume / time ThisIntermittent Volume / Time Modeallowsspeci-ficationofadelivery volumeforaspecific delivery time,afterwhichthedeliverystopsforaprogrammedinterval,thenthepatternrecycles.Inotherwords,thepumpdeliversforasetperiod,pausesasetperiod,theninfusesforasetperiod,andsoon.

• Thedelivery stop intervalequals“Time Between Starts”minus“Delivery Time.”

• Thepatternrepeatsat“TimeBetweenStarts”interval.

BelowarethestepsforprogramminganIntermittentVolume/Timeinfusion.SelectIntermittent Volume / Timefromtheselectionmenu(orchooseadrugprogramthatusestheintermittentvolume/timemodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34.

1. Usethenumberkeystosetthevolume.Volumeislimitedto500mL,andminimumvolumeis1/600thofsyringesize.Whenthevolumeiscorrect,pressEnter.


2. Usethenumberkeystosetthedeliverytime.Maximumandminimumtimesarecalculatedforthesyringeinuseand/orthecustomsetupintheConfiguration.Whenready,pressEnter.

3. Usethenumberkeystosetthetimebetweenstartsvalue.Maximumandminimumtimesarecalculatedforthedeliverytimeentered(minimumtimemustbeatleastoneminutelongerthanthedeliverytime;thepumpwillnotacceptdeliverytimesequaltoorlessthanthedeliverytime).Whenready,pressEnter.



BACKSPACE ENTER

ENTER VOLUME TO INFUSE - PRESS ENTER TO CONTINUE

HIGH: 500

LOW: 0.1

CLEAR

mL60

BACKSPACE ENTER

ENTER DELIVERY TIME

HIGH: 24:00:00

LOW: 00:04:00

CLEAR

:0000:55H R : M I N : S E C

BACKSPACE ENTER

ENTER TIME BETWEEN STARTS

HIGH: 24:00:00

LOW: 00:06:00

CLEAR

:0005:00HR:MIN:SEC


56

OPTIONS CLEAR TVD


MAIN MENU

VOLUME 60 mL TVD 0.000 mLTIME 00:55:00TIME BETWEEN STARTS 05:00:00 TIME REMAINING 00:55:00 RATE 65.5 mL/hr

6. Confirmthesettingsandstarttheinfusion,orusethethreemenukeysshownatrighttomodifythesettings.



Main Menu – returns to the Main Menu. Options – allows selection from a list of variables (e.g., standby, etc.). Clear TVD – clears total volume delivered.


57

Recall last settingsTheMedfusion®Model4000pumpwillrecalltheset-tingsusedtorunthelastinfusion.

Note:Ifapumphasacustomconfiguration(cre-atedusingPharmGuard®Toolbox2andtaughttothepump)theRecalllastsettingsfeatureisavailableonlyinthoseprofilesithasbeenincludedin.To use the feature, you must first enter the profile for the previous infusion.AnyOptionsusedintheinfusion(disablebolusdose,adjustalarmvolume,occlusionsetting,etc.)returntothedefaultsettingsandmustbereprogrammed.

Reusethesamedeliverysettingstorepeatanidenti-caldosageofmedicationorfluidstoapatient(choosethesyringemodelandsize,andloadthesyringeasinstructedonpage34):

1. SelectRecall Last Settingsfromtheselectionmenu.(Ifitisn'tshown,presstheMorekeyandsearchforit.)Inthisexample,pressthenumber4.

Whenselected,pressEntertoconfirmthesyringetypeandsizeifthesyringehasbeenreplaced.AfterthesyringehasbeenconfirmedtheContinue Same Infusionscreenappears.


3. IfNoispressed,thepumpreturnstotheMainmenutoselectadifferentDrugProgramorManualdeliverymode.

IfYesispressed,thepumppausesattheBegin InfusionscreenandPVDisnotcleared.Afterreviewingthesepreviouslyusedsettings,thepumppauses.TocleartheTVDandPVDorPDD,pressClear Totals.

(Forvolumelimitedinfusions,onlytheremainingvolumespecifiedwillbedelivered.)

MORE


1 mL / hr2 VOLUME / TIME3 DOSE / KG/ MIN4 RECALL LAST SETTINGS

MAIN MENU

NO

CONTINUE SAME INFUSION?

YES

VOLUME 10 mL PVD 0.487 mLWEIGHT 75 kg KVOLOAD 2000 mcg/kgDOSE 75 mcg/kg/min RATE 33.8 mL/hr


58


4. Whenalldeliverysettingsareconfirmedascorrect,pressÉtobegininfusion.Be sure all pump settings are correct before starting infusion.

TVD and PVD/PDD Retention:Thepumpalsore-tainsTVDandPVDorPDDfromthelastinfusion.Ifthesevaluesarenotwanted,youmustmanuallyclearthembeforebeginninganewinfusion.


59

Priming the systemPrimingisoneofthefunctionsofthePrime/Boluskey(è).Always prime a new syringe after loading it onto the pump and before connecting the tubing to the patient.Thisremovesthemechanical slackinthepumpandsyringe,andsignificantlyreducesstart-uptime.Theprimingsequenceisextremelyimportanttoassuretheaccuracyofthedeliveryandreducethestart-uptime.Theprimingsequenceisperformedaftertheinfusionisprogrammed,andbeforethede-liveryisstarted.ThemessageatthetopoftheBegin Infusionscreenwillalternatebetween“Press < «> To Begin Infusion”,and“Press < ««> To Prime”toremindyouoftheprimesequence.

WARNINGS: • NEVERprimeanysyringewhileconnectedtoapatientinfusionsite,asthismaycauseover-infusionwhichcouldresultinseriousinjuryordeath.•To avoid air embolism,alwayspurgeallairfromsyringeandinfusionlinesbeforeconnectingtothepatient.•Periodicallycheckthefluidpathwayandallconnec-tions(includingthecatheter/administrationsetcon-nection)forleaks.Leaksinthesystemmaycausefluidlossresultinginunder-delivery,aswellasallowinganopeningforcontamination.

1. Pressètoinitiatepriming.

2. Theprimingscreenopens.Toprimealoadedsyringe,pressandholdèwhileobservingforfluidmovementatthepatientendofthesystem.

3. Forsafetyreasons,primingstopsassoonasthefingerisliftedfromèorafter15seconds.Tocontinueprimingbeyondthe15-secondcutoff,releaseè,thenpress&holditagain.

Priming Volume Not Counted in TVD:Thetotalprimingvolumeaccumulatesonscreen,butisNOTcountedintheTotalVolumeDelivereddisplay.Thisisbecausethetubingisnotconnectedtothepatientduringprimingandthereforenotdeliveredtothepatient.ThePriminginfusionrateis300 mL/hr,orthede-faultmaximumbolusrateforthesyringesizebeingused,whicheverislower.

G6000912 Rev 0

PRIME / BOLUS

PRESS AND HOLD < «« > KEY TO PRIME

PRESS EXIT WHEN PRIME IS COMPLETE

PRIMING VOLUME 0.00 mL

EXIT


60

WARNING: Oncethesyringeandtubingsystemisconnectedtothepatient,raisingthesystemabovethepatient(evenbriefly)cancausesignificantbolusingduetochangesinhydrostaticpressure.Loweringthesystembelowthepatient(evenbrief-ly)cancausesignificantinterruptionsinflowduetochangesinhydrostaticpressure.Thiscouldcauseimproperpumpoperationresultingininaccuratefluiddeliverythatcouldresultinseriousinjuryordeath.Placethepumpasclosetothepatient'sinfu-sionsiteaspossible.

Oncethesystemisprimed,connectthetubingtothepatientandbegininfusion.


61

OptionsOptionsgivesyouaccesstoprogramoptionsthataf-fectthecurrent infusion only.The options available depend on the options that have been enabled for the profile and which have been customized for use using PharmGuard® Toolbox 2.Anyoptionsinusereturntothedefaultselectionwheneverthepumpisturnedoff,orwhenevertheprogramisreturnedtotheMainmenupriortobeginningthenextinfusion.TheseoptionsareavailablewhenthepumpisattheBegin Infusionscreen(priortostartinganinfu-sion):• OverrideOcclusionLimit• OverrideAlarmLoudness• Disable/EnableNearEmptyAlarmTone• Disable/EnableVolumeEmptyAlarmTone• BolusDose• DelayedStart• KVO• PeriodicCallbackAlarm• ChangetoDose/ChangetoVolume• LoadingDose• Standby• VolumeLimit• Disable/EnableFlowSentry™Theseoptionsareavailablewhenthepumpisrunninganinfusion:• BolusDose• OverrideAlarmLoudness• PeriodicCallbackAlarm• Disable/EnableVolumeEmptyTone• Disable/EnableNearEmptyTone• ChangetoDose/ChangetoVolume• Disable/EnableFlowSentry™

Note:Customizationsettingsinindividualdrugpro-gramstakepriorityoverprofilesettingsastowhichoptionsareavailable.Forinstance,whileBolusDoseandLoadingDosemaybeavailableasoptionsinagivenprofile,individualdrugprogramswithinthatprofilemayhavetheseoptionsdisabled,andyouwillthereforenotbeabletosetthemwhenusingthosespecificdrugprograms.


62

Bolus dosingABolus doseisaseparatedeliverythatpausesthemaininfusion,deliversthebolus(oftenatadifferent,higherrate),thenreturnstothemaininfusionwhencomplete.Itisanoptionalparameterofcontinuousdeliverymodeswhichallowsabolusvolumeordosetobedeliveredoveraspecifiedtime.Bolusdosemayalsobeconfiguredtobeautomatically“prompted”orincludedintheprogrammingstepsofadrugprogram.

BACKSPACE ENTER

ENTER BOLUS DOSE - PRESS ENTER TO CONTINUE

HIGH: 4

LOW: 0.2

CLEAR

MG/KG2DISABLE

Abolusmaybeprogrammedduringtheinitialinfu-sionsetup,attheBegin Infusionscreen,orduringaninfusionwithoutstoppingmedicationdelivery.IfBolusAutopromptissettoEnableinPharmGuard®Toolbox2,wheninitiallyprogrammingacontinuousinfusionthebolusprogrammingscreens(steps3-5,below)arepartofthedrugprogramsetup.PressingDisableatthebolusentryscreenwilldisablethebolusfeaturefortheduration of the infusion.

Bolus programmingIfprogrammingabolusattheBegin Infusionscreenorduringaninfusion:

1. PressOptions.

2. UsethenumberkeystochooseBolus Dose.

Steps3through5arethebolusprogram-mingscreens.IfAutopromptisEnabledinPharmGuard®Toolbox2,theyarepartofthenor-malinfusionprogrammingworkflow:

3. Iftheinitialinfusionisprogrammedinoneofthebodyweightmodes(e.g.Dose/Kg/Min),thebolus“dose”maybeprogrammedintheparametersofthatdosemode(e.g.Mg/Kg)orinTotalDose(e.g.Mg).Usethenumberkeystosetthedesiredbolusdoseforthisinfusion(ortosetthedosevolumeinmL,ifapplicablefortheinfusion).Volumeislimitedbythemaximumfillvolumeofthecurrentsyringesize,andminimumvolumeis1/600ththesyringesize.Whenthedosesetting(orbolusvolume)iscorrect,pressEnter.

Disable – turns Bolus off for the duration of the infusion. Clear – deletes an entry. Backspace – erases a character.



CHG DOSEMAIN MENU

CONC 10 mg/mL PVD 0 mLWEIGHT 40 kg

KVO MAX 9 mL/hrDOSE 4 mg/kg/hr RATE 16 mL/hr

LOCK

N

CHG DOSE OPTIONS CLEAR TVD

CONC 10 mg/mL TVD 1.408 mLWEIGHT 40 kg KVO

DOSE 4 mg/kg/hr RATE 16 mL/hr

EDketamine 10 mg/mL

≥

PRESS THE NUMBER TO SELECT THE PROGRAM OPTION

1 BOLUS DOSE 5 CHANGE TO DOSE2 OVERRIDE ALARM LOUDNESS3 OVERRIDE OCCL LIMIT4 DISABLE FLowSentry

BACKSPACE ENTER

ENTER BOLUS DOSE - PRESS ENTER TO CONTINUE

HIGH: 28.57

LOW: 0.0477

CLEAR

MG5DISABLE


63

NO

CONFIRM TOTAL BOLUS DOSE

BOLUS DOSE PER KILOGRAM 2 MG/KGWEIGHT 40 KG

YES

TOTAL BOLUS DOSE 80 MG

BACKSPACE ENTER

ENTER BOLUS TIME - PRESS ENTER TO CONTINUE

HIGH: 00:59:00

LOW: 00:01:00

CLEAR

HR : MIN : SEC00:01:00

4. Confirmthatthebolusdosesettingsandtotalbolusdosearecorrect.Ifincorrect,pressNo,andthepumpreturnstotheEnter Bolus Dosescreen.Ifcorrect,pressYes.Notethatthebolusdosemaybeenteredindose/kgorTotalDoseforweight-basedmodes(dependingonpumpcustomization).Theconfirmationscreenhighlights(inreverse)thevaluethatthepumpcalculates.

5. Usethenumberkeystosetbolusdeliverytimeinminutesandseconds.Thedefaultvalueforbolusdeliveryrateissetincustomconfiguration.Maximum&minimumtimeiscalculatedfromthemaximum&minimumrateforthesyringesizecurrentlyinuseand/orthecustomsetupintheConfiguration.(IfusingamanualdeliverymodeandtheBolusTimefeaturehasbeendisabledthepumpwilldefaulttothemaximumbolusrate.)Whenthebolustimeiscorrect,pressEnter.

UsingPharmGuard®Toolbox2,itispossibletorestrictbolustimetominutesonly.Ifthatisthecasethescreenwilllooklikethis:

ItisalsopossibletospecifyanabsolutetimelimitusingPharmGuard®Toolbox2,inwhichcaseyouwillnotbeabletochangeit.

Note:Ifthebolusisbeingprogrammedwhileaninfusionisdelivering,pressingEnterfollowingtimeentrywillcausetheBegin Bolus Delivery?screentobedisplayed.SeeBolus Delivery(startingatitem2inthesectionthatfollows)forinstructionsondeliveringthebolus.

BACKSPACE ENTER

ENTER BOLUS TIME - PRESS ENTER TO CONTINUE

HIGH: 00:59:00

LOW: 00:01:00

CLEAR

HR : MIN : SEC00:01:00

NO

CONFIRM TOTAL BOLUS DOSE

YES

TOTAL BOLUS DOSE 80 MG

BOLUS DOSE PER KILOGRAM 2 MG/KGWEIGHT 40 KG


64

CHG BOLUS NO

BEGIN BOLUS DELIVERY?BOLUS 2 MG/KG VOLUME 8 mLTIME 01:00 MM:SS RATE 480 mL/hr

YES

totaL boLUS doSe 80 mg

PRESS CANCEL TO STOP BOLUS DELIVERY DELIVERINGBOLUS 2 mg/kg DELIVERED 3.0760 mLREMAINING 00:37 MM:SS 30.7600 MGTOTAL BOLUS 80 MG RATE 480 mL/hr

CANCEL

CANCEL – stops the bolus and returns to the normal delivery rate and screen.

Bolus delivery1. Pressè(ifnecessary).

2. TheBegin Bolus Delivery?screenap-pears.Tobeginbolusdelivery,pressYes.Ifyoudonotwanttostartthebolusrightnow,pressNo.Ifyouwanttochangethebolusamount,pressCHG Bolusandrepro-gramthebolus(items3through5intheprecedingsection).


3. IfYeswaspressed,theBolus Deliveryscreenappears,with“Delivering”andthedrugprogramnamealternatelyappearing.

IfNowaspressed,thepumpreturnstothedeliveryscreen.Notethatthebolusinfor-mationappearsonthescreen.PressingèwillcausetheBegin Bolus Delivery?screentoreappear,whereyoucanbegindeliveringthebolus(seeabove).

G6000912 Rev 0

PRIME / BOLUS

LOCK

N


conc 10 mg/mL tvd 31.338 mLweight 40 kg kvo boLUS 2 mg/mLdoSe 4 mg/kg/hr rate 16 mL/hr

EDketamine 10 mg/mL

≥

CHG BOLUS NO

BEGIN BOLUS DELIVERY?

YES

totaL boLUS doSe 80 mg

BOLUS 2 MG/KG VOLUME 8 mLTIME 01:00 MM:SS RATE 480 mL/hr


65

CONTINUE SAME BOLUS? BOLUS 2 mg/kg DELIVERED 1.0910 mLREMAINING 00:52 MM:SS 10.9100 MGTOTAL BOLUS 80 MG RATE 480 mL/hr

YES NO

Continuing an interrupted bolus doseShouldaHigh Priorityalarmoccurduringbolusdelivery,orifáorCancelarepressed,theboluswillstop.Youcantheneithercontinuethebolusfromwhereitleftoff,orcancelthebolus.

1. Ifnecessary,pressítosilencethealarm.Troubleshootthealarmcondition.

2. PressÉ.

3. Either:• PressOptions,thenusethenumber

keystoselectBolus Dose.OR• PressÉ.

4. Tocontinuethebolusfromwhereitleftoff(deliveringonlywhatwasremaining),pressYes.

PressNotoexitthebolusscreen,cancelbolusdeliveryandreturntothemaininfusion.

OCCLUSION - CHECK INFUSION LINE ketamine 10 mg/mLBOLUS 2 mg/kg DELIVERED 1.0910 mLREMAINING 00:52 MM:SS 10.9100 MGTOTAL BOLUS 80 MG RATE 480 mL/hr

CANCEL

LOCK

N


conc 10 mg/mL tvd 31.338 mLweight 40 kg kvo boLUS 2 mg/mLdoSe 4 mg/kg/hr rate 16 mL/hr

EDketamine 10 mg/mL

#


1 BOLUS DOSE 5 CHANGE TO DOSE2 OVERRIDE ALARM LOUDNESS3 OVERRIDE OCCL LIMIT4 DISABLE FLowSentry


66

RESTRICTED FLOW - RATE REDUCED DELIVERINGBOLUS 2 mcg/mL DELIVERED 0.0040 mLREMAINING 00:54 MM:SS 1.00 MCG RATE 2.4 mL/hr

CANCEL

Bolus dose rate reductionTheincreaseddeliveryrateofabolusdosemaytriggeranocclusionalarm(dependingontheocclusionlimitsettingsinthepumpandthere-sistanceintheline).Ifthisoccurs,thebolusrateisautomaticallyreducedto70%.Thebolusrateisreducedbyincreasingthebolustimeoverthebolusvolume.Thebolusratecontinuestobereduceduntilresistanceisbelowthesetocclusionlimit.Therecouldbeavarietyofreasonsforthistooccur,including(butnotlimitedto)theocclusionlimitinuse,fluid/medicationviscosity,tubingsize,thepatient’sinfusionsitesetup,etc.

1. Pressítosilencethealarm.(Bolus delivery continues at the reduced rate.)

Thepumpcontinuestomonitortheinfusionandmayreducetheratemultipletimes.However,thefirstalarmistheonlyonethatproducesanaudibletone.Ifthefirstalarmissilenced,additionalratereductionswillnotcauseanaudibletonetosound,howevertheamber(yellow)LEDandthealarmmessagewilldisplayandcanbeclearedbypressingí.Ifthebolusratereducesbelowtheinfusionrate,orthebolustimeincreasespastthemaximumbolustime,thebolusiscancelled.

2. Pressítosilencethealarm.The normal infusion delivery is continued.

Oncethereasonfortheratereductioniscleared,youmayresumethebolus(ifdesired).Seethepre-viouspageforinstructions.

CANCEL – stops the bolus and returns to the normal delivery rate and screen.

RESTRICTED FLOW - BOLUS CANCELLED

TVD 0.447 mL

RATE 2.5 mL/hrLOCK

N

#



67

Loading dosesAloading doseisaseparate,specifiedvolume(ordose)ofdruginfusedasaone-time-onlybolus(oftenatadifferent,higherrate)priortothestartofnormaldelivery.Itisanoptionalparameterofcontinuousde-liverymodeswhichallowsabolusvolumeordosetobedeliveredoveraspecifiedtime.Aloadingdosemayalsobeconfiguredtobeautomatically“prompted”orincludedintheprogrammingstepsofadrugprogram.

Set up loading doseIfprogrammingabolusattheBegin Infusionscreen:

1. Setthedeliverymodeparameters.WhenthepumpispausedattheBegin Infusionscreen,pressOptions.

2. UsethenumberkeystochooseLoading Dose.(YoumayhavetopressMoretoseethisoption.)

Steps3through5arethebolusprogram-mingscreens.IfAutopromptisEnabledinPharmGuard®Toolbox2,theyarepartofthenor-malinfusionprogrammingworkflow:

3. Iftheinitialinfusionisprogrammedinoneofthebodyweightmodes(e.g.Dose/Kg/Min),theloading“dose”maybeprogrammedintheparametersofthatdosemode(e.g.Mcg/Kg)orinTotalDose(e.g.Mg).Usethenumberkeystosetthedesiredloadingdoseforthisinfusion(ortosetthedosevolumeinmL,ifapplicablefortheinfusion).Volumeislimitedbythemaximumfillvolumeofthecurrentsyringesize,andminimumvolumeis1/600ththesyringesize.Whentheloadingdosesetting(orvolume)iscorrect,pressEnter.


MORE

1 STANDBY 5 DELAYED START2 KVO 6 VOLUME LIMIT3 LOADING DOSE 7 DISABLE FLOWSENTRY4 OVERRIDE ALARM LOUDNESS 8 CHANGE TO DOSE

Disable – turns Bolus off for the duration of the infusion. Clear – deletes an entry. Backspace – erases a character.

AloadingdosemaybeprogrammedattheBegin InfusionscreenbypressingOptions.IfLoadingDoseAutopromptissettoEnableinPharmGuard®Toolbox2,wheninitiallyprogrammingacontinu-ousinfusiontheloadingdoseprogrammingscreens(steps3-5,below)arepartofthedrugprogramsetup.PressingDisableattheloadingdoseentryscreenwilldisablethefeaturefortheduration of the infusion.



CHG DOSEMAIN MENU

CONC 20 mg/mL PVD 0 mLWEIGHT 40 kg KVO

DOSE 33.3 mg/kg/hr RATE 66.6 mL/hr

BACKSPACE ENTER

ENTER LOADING DOSE - PRESS ENTER TO CONTINUE

HIGH: 30

LOW: 0.05

CLEAR

MG/KG15DISABLE

15 CURRENT SETTING


68

4. Confirmthattheloadingdosesettingsandtotalloadingdosearecorrect.Ifincorrect,pressNo,andthepumpreturnstotheEnter Loading Dosescreen.Ifcorrect,pressYes. Notethatthebolusdosemaybeenteredindose/kgorTotalDoseforweight-basedmodes(dependingonpumpcustomization).Theconfirmationscreenhighlights(inreverse)thevaluethatthepumpcalculates.

5. Usethenumberkeystosetdeliverytimeinminutes&seconds.Thedefaultvalueforloading(i.e.,bolus)deliveryrateissetincustomconfiguration.Maximum&minimumtimeiscalculatedfromthemaximum&minimumrateforthesyringesizecurrentlyinuse(ormaximumandminimumcanbesetusingPharmGuard®Toolbox2).

UsingPharmGuard®Toolbox2,itispossibletorestrictloadingtimetominutesonly.Ifthatisthecasethescreenwilllooklikethis:

UsingPharmGuard®Toolbox2,itisalsopossibletoexpandloadingtimetoupto12hours.Ifthatisthecasethescreenwilllooklikethis:

6. Aftertheloadingdoseissetandaccepted,thepumppauses.TheLoadingDosesettingnowappearsontheBegin Infusionscreen.Ifthisisanewinfusion,priortoconnectingtothepatientpressètoinitiatetheprimingsequence(page59).




CHG RATEMAIN MENU

CONC 20 mcg/mL PVD 0 mLWEIGHT 40 KG KVO

LOAD 15 MCG/KGDOSE 33.3 MG/KG/HR RATE 66.6 mL/hr

BACKSPACE ENTER

ENTER LOADING TIME - PRESS ENTER TO CONTINUE

HIGH: 00:59:00

LOW: 00:03:00

CLEAR

HR : MIN : SEC

00:03:0000:03:00 CURRENT SETTING

BACKSPACE ENTER


HIGH: 00:59:00

LOW: 00:03:00

CLEAR

HR : MIN : SEC


BACKSPACE ENTER


HIGH: 12:00:00

LOW: 00:03:00

CLEAR

HR : MIN : SEC


NO

CONFIRM TOTAL LOADING DOSE

LOADING DOSE PER KILOGRAM 15 MG/KGWEIGHT 40 KG

YES

TOTAL LOADING DOSE 600 MG

NO

CONFIRM TOTAL LOADING DOSE

YES

TOTAL LOADING DOSE 600 MG

LOADING DOSE PER KILOGRAM 15 MG/KGWEIGHT 40 KG


69

Delivering a loading dose1. Whenready,pressÉ.

2. TheBegin Loading Dosescreenappears.Dependingonwhichmodethepumpisdeliveringin,thescreenisslightlydifferent.

3. Tobegindeliveringtheloadingdose,pressYes.OR

•PressNotoskiptheloadingdoseandreturntotheNormal Deliveryscreen.OR

•PressChg Dosetochangetheloadingdosesettings.

•IfenabledinPharmGuard®Toolbox2andiftheloadingdosesettingshavebeenprogrammedinbodyweight,thekeylabeledChg In mL willallow thedosetobechangedinmLdirectly(ifenabled).

Note:Ifnokeysarepressedfor30seconds,theUserCallbackalarmwillsound.

4. IfYeswaspressed,theLoading Dose Deliveryscreenappearsandtheinfusionbegins,with“Delivering”andthelibrarynamealternatelyappearing.

Thepumpdeliverstheloadingdosethenauto-maticallyswitchestothenormaldeliveryrateandscreen.TheloadingdosevolumedeliveredisautomaticallyaddedtotheTotalVolumeDelivered(TVD)aswellastheProgrammedVolumeDelivered(PVD),orProgrammedDoseDelivered(PDD)forthatinfusion.

G6000912 Rev 0

PRIME / BOLUS

PRESS CANCEL TO STOP LOADING DOSE DELIVERY DELIVERINGLOAD 15 MG/KG DELIVERED 2.8280 mLREMAINING 02:43 MIN:SS 56.5600 MCGTOTAL LOAD 600 MG RATE 600 mL/hr

CANCEL

CANCEL – stops the loading dose and returns to the normal delivery rate and screen.

CHG DOSE NO

BEGIN LOADING DOSE DELIVERY?LOAD 15 MG/KGTIME 03:00 MM:SS RATE 600 mL/hr

YES

totaL Loading doSe 600 mg

CHG DOSE NO

BEGIN LOADING DOSE DELIVERY?

YES

totaL Loading doSe 600 mg

LOAD 15 MG/KGTIME 03:00 MM:SS RATE 600 mL/hr


70

Continuing an interrupted loading doseShouldaHigh Priorityalarmoccurduringload-ingdosedelivery,orifáorCancelarepressed,thedosewillstop.Youcantheneithercontinuethedosefromwhereitleftoff,orcancelthedose.


2. PressÉ.3. Tocontinuetheloadingdosefromwhere

itleftoff(deliveringonlywhatwasremaining),pressYes.

PressNotocanceltheremainderoftheloadingdoseandbeginthemaininfusion.

CONTINUE SAME LOAD? BOLUS 15 mg/kg DELIVERED 14.8340 mLREMAINING 01:31 MM:SS 296.6800 MGTOTAL BOLUS 600 MG RATE 600 mL/hr

YES NO

OCCLUSION - CHECK INFUSION LINE aminocaProic acid driP 20 mg/mLLOAD 15 mg/kg DELIVERED 14.8340 mLREMAINING 01:31 MM:SS 296.6800 MGTOTAL LOAD 600 MG RATE 600 mL/hr

CANCEL


71

Loading dose rate reductionTheincreaseddeliveryrateofaloadingdosemaytriggeranocclusionalarm(dependingontheocclusionlimitsettingsinthepumpandtheresis-tanceintheline).Ifthisoccurs,theloadingrateisautomaticallyreducedto70%.Theloadingrateisreducedbyincreasingtheloadingtimeovertheloadingvolume.Theloadingratecontinuestobereduceduntilresistanceisbelowthesetocclusionlimit.Therecouldbeavarietyofreasonsforthistooccur,including(butnotlimitedto)theocclusionlimitinuse,fluid/medicationviscosity,thepatient’sinfusionsitesetup,etc.

1. Pressítosilencethealarm.(Loading dose delivery continues at the reduced rate.)

Thepumpcontinuestomonitortheinfusionandmayreducetheratemultipletimes.However,thefirstalarmistheonlyonethatproducesanaudibletone.Ifthefirstalarmissilenced,additionalratereductionswillnotcauseanaudibletonetosound,howevertheamber(yellow)LEDandthealarmmessagewilldisplayandcanbeclearedbypressingí.Iftheloadingratereducesbelowtheinfusionrate,ortheloadingtimeincreasespastthemaximumloadingtime,theloadingdoseiscancelled.

2. Pressítosilencethealarm.The normal infusion delivery is continued.

Oncethereasonfortheratereductioniscleared,youmayresumetheloadingdose(ifdesired).Seethepreviouspageforinstructions.

RESTRICTED FLOW - RATE REDUCED DELIVERINGLOAD 50 MCG/KG DELIVERED 0.0960 mLREMAINING 09:52 MIN:SS 24.00 MCG RATE 60 mL/hrr

CANCEL

CANCEL – stops the loading dose and returns to the normal delivery rate and screen.

RESTRICTED FLOW - LOADING CANCELLED

TVD 1.702 mL

RATE 60 mL/hrLOCK

N

#



72

Volume limit AVolume LimitisanOptionavailableforcontinuous delivery modes.Onreachingthepresetvolumelimit,thepumpstops–orchangestoKVOifakeepveinopenratehasbeenprogrammed.Volumelimitisbasedontheamountofprogrammedvolumethatisdelivered.

Enable / Disable Volume Limit:IfVolume Limit isnotcurrentlyavailableasadosingoption,itcanbeenabledthroughcustompumpconfiguration(usingPharmGuard®Toolbox2).

Setting volume limit Avolumelimitcanbeseteitherbeforestartinganinfusionorbypausingthepumpduringaninfusion.VolumelimitisfoundintheOptionsmenu,whichyouaccessfromtheBegin Infusionscreen.

1. Withthepumpstopped,pressOptions.

2. UsethenumberkeytoselectVolume Limit.

3. Usethenumberkeystosetthevolumelimit,thenpressEnter.




CHG RATEMAIN MENU

PVD 0.000 mL

RATE 3.5 mL/hr


MORE

1 STANDBY 5 DELAYED START2 VOLUME LIMIT 6 LOADING DOSE3 OVERRIDE OCCL LIMIT 7 BOLUS DOSE4 OVERRIDE ALARM LOUDNESS 8 KVO

BACKSPACE ENTER

ENTER VOLUME LIMIT - PRESS ENTER TO CONTINUE

HIGH: 500

LOW: 0

CLEAR

mL50

DISABLERATE 3.5 mL/hr

Disable – turns Volume Limit off. CLEAR – deletes an entry. Backspace – erases a character.


73

4. Thevolumelimitsettingnowappearsonthedisplay.ProgramVolumeDelivered(PVD)willappearonthescreendirectlyabovetheV Limit.

5. Ifthisisanewinfusion,priortoconnectingtothepatientpressètoinitiatetheprimingsequence(page59).


6. PressÉtobegininfusion.Theinfusionwillautomaticallystopwhenitreachesthepresetvolumelimit.



CHG RATEMAIN MENU

PVD 0.000 mL V LIMIT 50 mL

RATE 3.5 mL/hr


74

Keep Vein Open (KVO) rateTheKeep Vein Open(KVO)rateisanOptionavailableforcontinuousdeliverymodes.Thekeep vein openfeatureisintendedforusewhendeliveringaseriesofinfusionstoapatient,andthede-liverysitemustremainpatentbetweentheendofoneinfusionandthebeginningofthenext.

• Avolume limitmustbeprogrammedforKVOtowork.Afteravolumelimitisreached,alowrate(KVO)issettomaintainpatencyoftheinfusionsite.

• TherangeofratesavailableappearsontheEnter KVO Ratescreen.KVOratesarecalcu-latedbysyringesizeanditsminimumflowrate.

• TheprogrammedKVOratemustbeless thanthenormaldeliveryrateandgreater than or equal tominimumflowrateforthesyringe.Once the volume limit has been reached, the pump will

begin infusing at either the programmed KVO rate or the current infusion rate, which ever is less.

AKVOratecanbesetattheBegin Infusionscreenbeforestartinganinfusionorbypausingthepumpduringaninfusion.KVOcanalsobeprogrammedaspartofthedrugprogramusingPharmGuard®Toolbox2.

Note:ThesettingofKVOratesshouldbebasedonaphysician'sorderoryourfacility’spoliciesandproce-duresforratedetermination.

Enable / Disable KVO Rate:KVO ratecanbeenabledordisabledthroughcustompumpconfiguration(us-ingPharmGuard®Toolbox2).

Programming KVO rate1. Withthepumpstopped,pressOptions.

2. UsethenumberkeystochooseKVO.

3. UsethenumberkeystosettheKVOratewithintheminimumandmaximumratesonscreen.WhentheKVOrateisset,pressEnter.

4. TheKVOsettingnowappearsonthescreen.




CHG RATEMAIN MENU

PVD 0.000 mLBOLUS 2.5 mL V LIMIT 50 mL

RATE 3.5 mL/hr


MORE


BACKSPACE ENTER

ENTER KVO RATE - PRESS ENTER TO CONTINUE

HIGH: 3.5

LOW: 0.1

CLEAR

mL/hr0.6DISABLE



CHG RATEMAIN MENU

PVD 0.000 mLBOLUS 2.5 mL V LIMIT 50.003 mL KVO RATE 0.6 mL/hr RATE 3.5 mL/hr


75


6. PressÉtobegininfusion.7. Whentheinfusionreachestheprogrammed

volumelimit,ratherthanstoppingdelivery,thepumpautomaticallybeginsdeliveryattheKVOrate(orcontinuesatthecurrentrateiflessthantheKVOrate)andtriggersanalarm.

8. KVOdeliveryautomaticallystopswhenthepumpcalculatesthesyringeisempty,orifáwaspressed.Whenthepumpautomaticallystopskeepveinopeninfusion,itsoundsa“syringeempty”alarm.

Stop KVO Infusion:StopaKVOinfusionatanytimebypressingá.

Silence KVO Alarm:Silencethealarmbypressingí.

KVO IN PROGRESS

PVD 50.0030 mL KVO V LIMIT 50 mL

RATE 0.6 mL/hrLOCK

N


76

StandbyStandbyisanOptionthatallowsthepumptore-mainattheBegin InfusionscreenwithouttheUser CallbackalarmsoundingfortheStandbyperiod.

• Thepumpdoes not automatically startaninfu-sionattheendofthestandby.

• Instead,thepumptriggersanalarmattheendofthestandbyperiod.



CHG RATEMAIN MENU

PVD 0.000 mLBOLUS 2.5 mL V LIMIT 50 mL KVO RATE 0.6 mL/hr RATE 3.5 mL/hr


MORE


BACKSPACE ENTER

ENTER STANDBY TIME - PRESS ENTER TO CONTINUE

HIGH: 24:00:00

LOW: 00:00:00

CLEAR

HR : MIN : SEC01:00:00


STANDBY TIME REMAINING 00:59:50

CHG RATEMAIN MENU


Enable / Disable Standby:TheStandbyoptioncanbeenabled/disabledthroughcustomconfiguration(us-ingPharmGuard®Toolbox2).

Programming standby1. WhenthepumpispausedattheBegin

Infusionscreen,pressOptions.

2. UsethenumberkeystochooseStandby.

3. SettheStandbytimeinhours&minutes.ThemaximumStandbysettingis24hours.Thedefaultstandbytimeis1:00Hr.WhentheStandbytimeiscorrect,pressEntertoacceptthestandbysettingandgototheBegin Infusionscreen.

4. Thestandbytimerthenappearsintheupperrightcorneronscreen“counting down”alternatelywith“Press < « > To Begin Infusion”andtheDrugProgramname.TheUser Callbackalarmisdisabledforthisinterval.Standbycontinuesuntilthetimerhascountedtozero.StandbycanbediscontinuedatanytimebypressingÉ,whenMain Menuispressedtoreturntothemainmenu,orbysettingstandbytozero.



77

6. Whenthecounterreacheszero,thepumpsoundsanalarmremindingyoutobegintheinfusion.



78

Delayed startDelayed StartisanOptionthatallowsthepumptoremainattheBegin InfusionscreenwithouttheUser Callbackalarmsoundingforthespecifiedperiod,thenautomaticallystartstheinfusionattheendoftheDelayedStartperiod.

Programming delayed start1. WhenthepumpispausedattheBegin

Infusionscreen,pressOptions.

2. UsethenumberkeystochooseDelayed Start.

3. SettheDelayedStarttimeinhours&minutes.Themaximumdelayedstartsettingis6hours.Thedefaultdelayedstarttimeis1:00Hr.WhenDelayedStartiscorrect,pressEntertoacceptthesettingandgototheBegin Infusionscreen.

4. TheDelayedStarttimerthenappearsintheupperrightcorneronscreen“counting down”alternatelywith“Press < « > Key To Start Infusion Immediately”andtheDrugProgramname.TheUser Callback alarmisdisabledforthisinterval.DelayedStartcontinuesuntilthetimerhascountedtozero.DelayedStartcanbediscontinuedatanytimebypressingÉ,orbysettingDelayedStarttozero.



6. Whenthecounterreacheszero,thepumpautomatically begins the infusion.



CHG RATEMAIN MENU



MORE


BACKSPACE ENTER

ENTER DELAYED START TIME - PRESS ENTER TO CONTINUE

HIGH: 06:00:00

LOW: 00:00:00

CLEAR

HR : MIN : SEC01:00:00


TIME UNTIL START OF INFUSION 00:59:50

CHG RATEMAIN MENU


Enable / Disable Delayed Start:TheDelayed Startop-tioncanbeenabled/disabledthroughcustomcon-figuration(usingPharmGuard®Toolbox2).


79

Periodic callback alarmThePeriodiccallbackalarmisanOptionthatcausesanalarmtobegeneratedataprogrammedperiodoftime.

Note:Duringdeliveryofaloadingdose,bolusdose,orflushdelivery,theperiodiccallbacktimerissus-pended,thenrestartsoncetheoptionaldeliveryiscomplete.Forexample,ifyouhaveperiodiccallbacksetfor1hour,thendeliverabolusdosewhichlasts10minutes,theperiodiccallbackwillactuallyoccurat1hourand10minutes.

Programming periodic callback alarm

1. Withthepumpdeliveringaninfusionorpaused,pressOptions.

2. UsethenumberkeystochoosePeriodic Callback Alarm.(YoumayneedtopressMoretoseeit.)

3. Setthecallbackalarmtimeinhours&minutes.Themaximumperiodiccallbacksettingis8hours.Thedefaultcallbacktimeis2:00Hr.Whenthecallbackalarmtimeiscorrect,pressEntertoacceptthesettingandgototheBegin Infusionscreen.





CHG RATEMAIN MENU



MORE

1 DISABE FLOWSENTRY 5 CHANGE TO DOSE2 DISABLE NEAR EMPTY TONE 6 DISABLE FLOWSENTRY3 DISABLE VOL EMPTY TONE4 PERIODIC CALLBACK ALARM

BACKSPACE ENTER

ENTER PERIODIC CALLBACK ALARM TIME - PRESS ENTER

HIGH: 08:00:00

LOW: 00:00:00

CLEAR

HR : MIN : SEC02:00:00

Enable / Disable Periodic Callback Alarm:ThePeri-odic Callback Alarmoptioncanbeenabled/disabledthroughcustomconfiguration(usingPharmGuard®Toolbox2).


80

5. Whenready,pressÉtobegininfusion.Oncetheinfusionstarts,thePeriodicCallbackAlarmsoundsaMediumpriorityalarmatthetimeintervalprogrammed.ThePeriodicCallbackAlarmcanbediscontinuedatanytimebychangingthePeriodicCallbackAlarmtimetozero.


PERIODIC CALLBACK - SILENCE ALARM TO CONTINUE

CHG RATEMAIN MENU


N


81

Override and toggle featuresWhenthepumpispausedattheBegin Infusionscreen(or,insomecaseswhileinfusing),pressingOptionsgivesyouaccesstoseveraloverrideandtog-gleoptionsthatwillaffectthecurrentinfusiononly.TheseOptionswillreturntothedefaultselectionwheneverthepumpisturnedoff,orwhenevertheprogramisreturnedtotheMainmenupriortobe-ginningthenextinfusion.


MORE

1 BOLUS DOSE 5 OVERRIDE OCCL LIMIT2 PERIODIC CALLBACK ALARM 6 CHANGE TO DOSE3 OVERRIDE ALARM LOUDNESS 7 VOLUME LIMIT4 DELAYED START 8 DISABLE FLOWSENTRY



CHG DOSEMAIN MENU

CONC 1.5 mg/mL PVD 0 mLWEIGHT 5 kg DOSE 20 mgTIME 02:00:00TIME REMAINING 02:00:00 RATE 6.67 mL/hr



CHG DOSEMAIN MENU

CONC 1.5 mg/mL PDD 0 mcgWEIGHT 5 kg DOSE 20 mgTIME 02:00:00TIME REMAINING 02:00:00 RATE 6.67 mL/hr

PVD (Program Volume Delivered) indicates Volume is currently selected

PDD (Program Dose Delivered) indicates Dose is currently selected

Change to Dose / Change to Volume Whendeliveringadrugprogramorinfusioncontainingaconcentration(mustbea“continu-ous”styleinfusion),youmaywanttovieweitherthevolumedelivered(PVD)orthedosedelivered(PDD).ThetogglePVD/PDDoptionmaybeusedattheBegin Infusionscreen,orduringaninfu-sionwithoutstoppingmedicationdelivery.

1. WiththepumpattheBegin Infusionscreen(orduringmedicationdelivery),pressOptions.

2. UsethenumberkeystochooseChange to DoseorChange to Volume(onlyoneortheotherwillbeshown,dependingonthecurrentsetting).(YoumayhavetopressMoretoseethisoption.)

3. PVDwillchangetoPDD(orvice-versa,dependingonthecurrentsetting).Seepage96formoreinformationonPVD/PDD.


82

Override occlusion limit Thepump’sprogrammeddefaultocclusionsettingcanbeoverridden.Thisallowssettingahigherorlowerocclusionlimitforaspecificinfusion.

Note: Whena1mLsyringeisenteredintotheprogrammingtheocclusionpressuresettingisfixedatvery high-50psi,meaningyoudonothavetheoptionofchangingit.

1. Setthedeliverymodeparameters.WhenthepumpispausedattheBegin Infusionscreen,pressOptions.

2. UsethenumberkeystochooseOverride Occl Limit.(YoumayhavetopressMoretoseethisoption.)

3. Thehighlightshowsthepump’scurrentdefaultsetting.Usethenumberkeystochoosetheocclusionsettingyouwanttouse,thenpressEnter(seethetableonpage92formoreinformationaboutocclusionsettings).


MORE


SELECT OCCLUSION LIMIT - PRESS ENTER TO CONTINUE

ENTER

1 VERY LOW - MOST SENSITIVE2 LOW3 NORMAL4 HIGH - LEAST SENSITIVE



CHG RATEMAIN MENU



83

Override alarm loudnessOccasionallyitmaybenecessarytochangetheloudnessoftheaudiblealarm.Forinstance,iftheinfusionistakingplaceinanareawithalotofam-bientroomnoisetheloudestalarmsettingmaybewanted.ThealarmloudnesscanbesetfromLevel1(quietest)toLevel5(loudest),howeveritcannotbedisabledorcompletelysilenced.

1. Withthepumprunningorstopped,pressOptions.

2. UsethenumberkeystochooseOverride Alarm Loudness.(YoumayhavetopressMoretoseethisoption.)

3. Thehighlightshowsthepump’scurrentdefaultsetting.Usethenumberkeystochoosethedesiredalarmloudnesssetting,thenpressEnter.

Todeterminewhichsettingmeetsyourneedsfortheinfusion,usethenumberkeytochoosealoudnesslevelthenpressTest.


MORE


ADJUST LOUDNESS - PRESS ENTER TO CONTINUE

ENTERTEST

1 LEVEL 1 5 LEVEL 52 LEVEL 23 LEVEL 34 LEVEL 4



CHG RATEMAIN MENU



84

Disable/enable FlowSentry™Thepumphasaninternalprogramforrapidocclu-siondetectioncalledFlowSentry™.Thepumpmayhavebeenconfiguredtoeitherturnthisfeatureonoroff.Tochangethedefaultconfigurationforaspecificinfusion,usethisoption.

Note: WithcertainPharmGuard™SupportedSyringes(PSS)Series2,suchasthoseforenteraldelivery,FlowSentry™isautomaticallydisabledandcannotbeenabled.


2. UsethenumberkeystochooseDisable FlowSentryorEnable FlowSentry(onlyoneoftheabovewillbedisplayed,dependingonwhethertherapidocclusiondetectionfeatureiscurrentlyactiveornot).(YoumayhavetopressMoretoseethisoption.)


BEGINNING

1 DISABLE FLOWSENTRY2 DISABLE NEAR EMPTY TONE3 DISABLE VOL EMPTY TONE

Disable/enable near empty alarm toneThepumpmaybeconfiguredtohaveanalarmsoundtoindicatewhenasyringeisnearlyempty.(Alarmtriggeringiscalculatedbasedonthesyringesizeusedandthevolumeinitiallycalculated;seepage101foranexplanationofthisalarm.)Usethisoptiontoenableordisablethisfeatureforthisinfusion.


2. UsethenumberkeystochooseDisable Near Empty ToneorEnable Near Empty Tone(onlyoneoftheabovewillbedisplayed,dependingonwhethertheNearEmptyAlarmfeatureiscurrentlyactiveornot).(YoumayhavetopressMoretoseethisoption.)


BEGINNING




CHG RATEMAIN MENU




CHG RATEMAIN MENU



85

Disable/enable vol empty alarm toneThepumpmaybeconfiguredtohaveanalarmsoundtoindicatewhenthevolumeofmedicationinasyringeisnearempty.(Thecalculationforwhenthealarmsoundsisbasedonthesyringesizeusedandthevolumeinitiallyprogrammed.)Usethisoptiontoenableordisablethisfeatureforthisinfu-sion.


2. UsethenumberkeystochooseDisable Empty ToneorEnable Empty Tone(onlyoneoftheabovewillbedisplayed,dependingonwhethertheEmptyAlarmfeatureiscurrentlyactiveornot).(YoumayhavetopressMoretoseethisoption.)


BEGINNING




CHG RATEMAIN MENU



86

Infusion DeliveryStarting & stopping infusion deliveryAninfusiondeliverycanbestartedatanytimeafteradeliverymodehasbeensetup.Aninfusioncanbestartedfromapause,standby,ordelayedstartscreen.Prior to connecting the tubing to the patient and starting an infusion, press è to initiate the priming sequence(page59).

Start delivery from pauseWheneverbeginninganinfusionsetupandpro-gressingallthewaythroughthesetuplevels,thepumppausesattheBegin Infusionscreen.

1. Programaninfusion.2. Verifyallvaluesarecorrect.

3. PressÉ.4. Thepumpbeginstheinfusion.




DOSE 1 MCG/KG/MIN RATE 1.2 mL/hrCHG DOSEMAIN MENU

G6000912 Rev 0

PRIME / BOLUS

WARNING: Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatadeliveryrateotherthanthatprescribedwillcauseinappropriatedelivery,whichcanresultinseriousinjuryordeath.


87

Starting delivery from standby or delayed startStarttheinfusionatany timewhenthepumpisonstandbyordelayedstart.Itisunnecessarytoeithercancelstandbyorwaituntilthestandbyperiodends.

1. Tostartinfusionfromstandbyordelayedstart,pressÉ.

2. Beforestartingtheinfusion,youmayalso:a) ReturntotheMainmenu.b) ChangetheRate(orDose).c) Changedeliveryoptions,suchasvolume

limitorbolusdose.d) ClearTotals.

G6000912 Rev 0

PRIME / BOLUS

Stopping deliveryAninfusioncanbestoppedatany time,inanydeliverymode.

1. Ifthereisanactivealarm,firstsilenceit.Pressá.

2. Theinfusingindicatorsturnoffandthepumppauses.Youmayrestarttheinfusion,orchangesettingsandrestart.Or,turnthepumpoff.

G6000912 Rev 0

PRIME / BOLUS


TIME UNTIL START OF INFUSION 00:59:50

CHG RATEMAIN MENU


NO

CONTINUE SAME INFUSION?

YES


Continuing interrupted deliveryAninfusioncanbecontinuedfromwhereitleftoffshoulditbeinterruptedforanyreason.

1. Ifthereisanactivealarm,firstsilenceit.2. Tocontinuetheinfusion,pressYes. PressNotocanceltheremainderofthe

infusionandreturntotheMainmenu.


88

Flush featureSomemedicationsandinfusionsmayrequireflush-ingthelinetoremoveanyresidualmedicationorinfusate.UsingPharmGuard®Toolbox2,thisfeaturecanbeenabledforcertainprofiles,facilitatingthepumptoautomaticallypromptflushingthetubingwhenaninfusioniscomplete.Thepumpmayprompttosetadeliverytimefortheflush,oronlytospecifyavolume(dependingonhowthefeatureisenabled).

Thisfeatureisonlyavailableifenabledforintermit-tent(timed)infusions(forexample,Dose/kg/Time,Volume/Time,mL/Kg/Time,etc.),andisnotavailableforcontinuousinfusions.Dependingonthepump’scustomconfiguration,avolumelimitmayhavebeensetthedrugprogramusingPharmGuard®Toolbox2.

Volume only1. Whentheprogrammedinfusioniscomplete

ortheSyringe Emptyalarmactivatesandthepumpalarms,pressí.

2. TheBegin Flush Setupscreenappears.Ifyoudonotwanttostarttheflushatthispoint,pressNo(thepumpwillreturntotheBegin Infusionscreen).Ifyoudowanttobegintheflushsetup,pressYes.

3. Removethesyringeattheendoftheinfusionwhenpromptedandreplacewiththeflushsyringe.Pressthenumberkeytoselectthesyringemodel.

4. Loadthesyringeontothepump,verifythecorrectsizeisshown,thenpressEnter.

5. Usethenumberkeystoenterthedesiredamountofflushinginfusate,thenpressEnter.Volumeislimitedbythesizeofthesyringebeingused,andmayalsobelimitedbyanycustomconfigurationsettings.

6. Tobeginflushdelivery,pressConfirm.OR •PressChg VoltoreturntotheFlush

Volumescreenandchangethevolume.OR •PressMain Menu(ortheQuick Library)

toskiptheflushdeliveryandreturntotheMainmenu.

OPTIONS CLEAR TVD

INFUSION COMPLETE

VOLUME 50 mL PVD 50 mLTIME 00:25:00

TIME REMAINING 00:00:00 RATE 120 mL/hrMAIN MENU

NO

BEGIN FLUSH SETUP?

YES


ENTER

LOAD SYRINGE - PRESS ENTER WHEN READY

B-D 5mL

BACKSPACE ENTER

FLUSH VOLUME TO INFUSE - PRESS ENTER TO CONTINUE

HIGH: 3

LOW: 0.033

CLEAR

mL

CHG VOL CONFIRM

CONFIRM FLUSH SETTINGS?

VOLUME 1.5 mLTIME 00:01:30 RATE 60 mL/hrMAIN MENU


89


7. WhenConfirmispressed,theflushinfusionbeginsdelivering,with“Flushing”andthelibrarynamealternatelyappearing.Theflushiscalculatedtodeliveratthesamerateasthepreviousinfusion.

Tocancelorstopthedelivery,pressá.)Ifflushdeliveryiscancelled/stopped,orshouldanalarminterruptflushdelivery,youwillhavetheoptionofrestartingit(seebelow).

8. Whentheflushinfusionhasbeendelivered,deliverystopsandthepumpalarms.Pressítosilencethealarm,thenpressMain Menu.

PRESS < > TO STOP FLUSH DELIVERY

VOLUME 1.5 mL FLUSHED 0.08 mLTIME 00:01:30 REMAINING 00:01:22 RATE 60 mL/hr

FLUSHING

INFUSION COMPLETE

VOLUME 1.5 mL FLUSHED 1.50 mLTIME 00:01:30 REMAINING 00:00:00 RATE 60 mL/hrMAIN MENU

FLUSH STOPPED - PRESS < « > KEY TO CONTINUE


CONTINUE SAME FLUSH?


YES

Pvd 0.23 mL

NO


CANCEL

OCCLUSION - CHECK INFUSION LINE

Continuing an interrupted flush infusionShouldaHigh Priorityalarmoccurduringflushinfusiondelivery,orifáispressedtointerruptaflushinfusion,deliverywillstop.Youcanthenei-thercontinuethedosefromwhereitleftoff,restartanewdose,orcancelthedose.


2. PressÉ.

3. Tocontinuetheflushinfusionfromwhereitleftoff(deliveringonlywhatwasremaining),pressYes.

PressNotocanceltheremainderoftheflushinfusionandreturntotheMainmenu.

FLUSH STOPPED - PRESS < « > KEY TO CONTINUE



90

Volume and time1. Whentheprogrammedinfusionis

completeortheSyringe Emptyalarmactivatesandthepumpalarms,pressí.

2. TheBegin Flush Setupscreenappears.Ifyoudonotwanttostarttheflushatthispoint,pressNo(thepumpwillreturntotheBegin Infusionscreen).Ifyoudowanttobegintheflushsetup,pressYes.

3. Removethesyringeattheendoftheinfusionwhenpromptedandreplacewiththeflushsyringe.Pressthenumberkeytoselectthesyringemodel.

4. Loadthesyringeontothepump,verifythecorrectsizeisshown,thenpressEnter.

5. Usethenumberkeystoenterthedesiredamountofflushinginfusate,thenpressEnter.

6. Thepumprequiresconfirmationthattheflushbedeliveredatthesamerateasthepreviousinfusion.Todeliveratthesamerate,pressYes(thepumpwillthenautomaticallycalculatethedeliverytime).Todeliveratadifferentrate,pressNo.

7. IfNowaspressed,theFlush Timescreenappears.Usethenumberkeystoselectthedeliverytime,thenpressEnter.

OPTIONS CLEAR TVD

INFUSION COMPLETE PVD 1 mLWEIGHT 1 KGTIME 00:03:00 VTBI 1 mLTIME REMAINING 00:00:00 RATE 20 mL/hrMAIN MENU CHG DOSE

NO

BEGIN FLUSH SETUP?

YES


ENTER

LOAD SYRINGE - PRESS ENTER WHEN READY

B-D 5mL

BACKSPACE ENTER

FLUSH VOLUME TO INFUSE - PRESS ENTER TO CONTINUE

HIGH: 3

LOW: 0.005

CLEAR

mL

NO

CONFIRM SAME RATE?

YES

BACKSPACE ENTER

FLUSH TIME - PRESS ENTER TO CONTINUE

HIGH: 00:10:00

LOW: 00:02:00

CLEAR

H R : M I N : S E C

00:00:00


91

8. Tobeginflushdelivery,pressConfirm.OR •PressChg VoltoreturntotheFlush

Volumescreenandchangethevolume.OR

•PressChg TimetoreturntotheFlush Timescreenandchangethetime.OR

•PressMain Menu(ortheQuick Library)toskiptheflushdeliveryandreturntotheMainmenu.


9. WhenConfirmispressedtheflushinfusionbeginsdelivering,with“Flushing”andthelibrarynamealternatelyappearing.

Tocanceltheflush,pressCancel.Ifflushdeliveryiscancelled,orshouldanalarminterruptflushdelivery,youwillhavetheoptionofrestartingitbypressingFlush(oriffinishedpressMain Menu(ortheQuick Library)toexit).

10.Whentheflushinfusionhasbeendelivered,deliverystopsandthepumpalarms.Pressítosilencethealarm,thenpressMain Menu.

PRESS CANCEL TO STOP FLUSH DELIVERY


CANCEL

FLUSHING

INFUSION COMPLETE


FLUSH STOPPED

VOLUME 1.5 mL FLUSHED 0.02 mLTIME 00:04:30 REMAINING 00:03:22 RATE 20 mL/hrMAIN MENU FLUSH

CHG VOL CONFIRM

CONFIRM FLUSH SETTINGS?

VOLUME 1.5 mLTIME 00:04:30 RATE 20 mL/hrMAIN MENU CHG TIME


92

Time to occlusionThetimeforthepumptodetectanocclusionisaf-fectedbythreefactors:1. Occlusion Pressure Setting–High(H),Normal

(N),Low(L),orVeryLow(VL).2. Flow Rate Setting.3. Syringe & Tubing Compliance,(i.e.,softnessof

syringeplungertiportubing).ReferencetheSpecificationssectionofthismanual(page124)fortypicaltime-to-occlusionsvalues.Seeguidelinesforpumpperformanceontimetoocclu-sion.Atlowerratessmallersyringeshaveshorterocclusiontimes,whichiswhythesmallestavailablesyringeforthevolumetobedeliveredshouldalwaysbeused.

Occlusion trend graph during deliveryThepumpautomaticallymonitorsocclusionorsyringebackpressureduringanyinfusion.Thistrendappearsinabar graphontherightsideofthedisplayduringdelivery.Theletteratthetopofthegraphindicatestheconfiguredocclusionalarmlevel:

Code Meaning Relative PressureVH VeryHigh(fixedfor

1mLsyringes)50psi(345kPa)

H High 16psi(110kPa)N Normal 12psi(83kPa)L Low 8psi(55kPa)VL VeryLow 4psi(28kPa)

Thepressuregraphisscaledbetween0psiatthebot-tomandtheOcclusionsettingpressureatthetop.TheocclusionlimitcanbesetfromVeryLowtoHighforsyringeswithavolumegreaterthan1mL.Theoc-clusionlimitisafixedvaluefor1mLsyringes.Thesettingfor1mLsyringesisfixedat50psi,meaningyouarenotabletochangethesetting.Thereasonforthisisthatatlowerpressuresettingsocclusionalarmswouldbefrequent.Pressuresintheabovetableareonlyapproximations.Thisisbecausesyringefrictionaffectstheactualpres-surelevel.OcclusionlimitdefaultissetupusingPharmGuard®Toolbox2,whichwascompletedbythepersonre-sponsibleforcustomConfigurationbeforethepumps

weredeliveredtoaworkarea.YoucanoverridethedefaultOcclusionlimitforaparticularinfusionfromtheOptionsmenuifthatoptionisenabled.Thepumptakesthepressuremeasurementapproxi-matelyeverysecond:• Theright sideofthebaristhemostcurrentread-

ing.• Themiddle baristhe1minuteaverage.• Thefar left baristhe2minuteaverage. Therefore:

PVD 0.55 mL

RATE 10 mL/hr

LOCK

N


100%B-D 60mL

• Ifthegraphslopesupwardfromlefttoright,thenthepumpisheadedtowardocclusion.

PVD 0.55 mL

RATE 10 mL/hrLOCK

N


100%B-D 60mL

• Ifthegraphislevel,thenbackpressureissteady.

FlowSentry™ (rapid occlusion detection)FlowSentry™isaninternalprogramuniquetoMedfusion®syringepumpsthatmonitorsandana-lyzesdeliverypressure.Whenactivated,FlowSentry™alertsyoutotheexistenceofanocclusionmuchmorerapidlythanconventionalocclusionalarmsystems.ThesensitivityoftheFlowSentry™settingisdeter-minedbytheselectioninthecustomConfiguration,usingPharmGuard®Toolbox2.How do you know if FlowSentry™ has been acti-vated?• Duringstartupandduringthestabilizationpe-

riodfollowingaratechangeapoundsign(#)willappeartotheleftofthepressuretrendgraph.Thepresenceofthe#indicatesthatFlowSentry™isac-tive,andthatthedeliverypressureisstabilizing.


93

Note: FlowSentry™isdisabledatratesgreaterthanroughly⅓ofthesyringesizeperhour.Seethetableatrightformoreinformation.

TVD 1.60 mL PVD 1.60 mL

RATE 10 mL/hr

LOCK

H


#

60mLB-D

• Oncethedeliverypressurehasreachedastablelevelthe#signwillbereplacedbyahorizontalar-row(≥).


RATE 10 mL/hr

LOCK

H


B-D 60mL

≥

• Ifthereisanincreaseinthedeliverypressurethehorizontalarrowwillbereplacedbyaverticalar-row(¤).


RATE 10 mL/hr

LOCK

H


B-D 60mL

¤

Inthiswayyoucaneasilyseea)thatFlowSentry™isactivated,andb)whetherthedeliverypressureisstabilizing,steady,orincreasing.IntheeventthattheFlowSentry™hasnotbeenactivatedtherewillbeno#orarrowsignstotheleftofthepressuretrendgraph.FlowSentry™isautomaticallydisabledwhenthedeliv-eryrateforasyringesizeisexceededasindicatedinthefollowingtable:

Syringe Size FlowSentry™ maximum infusion rate

60mL 20mL/hr50mL 20mL/hr35mL 12mL/hr30mL 10mL/hr20mL 6.6mL/hr12mL 3.3mL/hr10mL 3.3mL/hr6mL 1.65mL/hr5mL 1.65mL/hr3mL 1mL/hr

IfFlowSentry™isdisabled,thebargraphisstillshown,howevernoneoftheicons(#,≥or¤)willap-pearonscreen.

Post occlusion bolus reduction Withlargesyringes,fluidcanaccumulateorbe“stored”inthelinewhenanocclusionhappens,whichisthendeliveredasaboluswhentheocclusionisre-leased.Thisstoredvolumeistheresultofthevolumeofthesyringeandinfusionsetincreasingunderpres-sure.Thispumpcontainsafeatureforreducingthisbolusuponocclusionrelease(orocclusionbolus).Usingpostocclusionbolusreduction,thepumpwithdrawstheplungerapredeterminedamounttoreduce“stored”bolusinthesyringe.However,thisfeaturedoesnottotallyeliminatetheocclusionbolus.Occlusionboluswillvarygreatlywithocclusionlimitsetting,syringesize,andthefluidinfused.Thepost-occlusionbolusreductionfeaturedecreasesbolusonocclusionreleasetolessthan0.3mL.

WARNING:LargersizesyringesatocclusionsettingHIGHmayproduceapostocclusionboluslargerthan0.3mLduetoexcessivesyringeplungertipcompli-ance.


94

Making changes during delivery

Atrightisanillustrationofadeliveryscreen.Thereareeightoptionsavailableduringanystandardinfu-sion.Whilerunninganinfusion,youmay:

• Lock/Unlockthekeypad.• ChangetheDosageRate.• SelectcertainProgramOptions.• ClearTVD• Pressètoset,change,ordeliverabolus.• Pressátopauseorendtheinfusiondelivery.• Pressëtobeginpumpshutdown.• Pressítosilenceanalarm.

Changing delivery rateTheMedfusion®Model4000pumpsofferwaysofchangingdeliveryrateeitherbeforebeginninganin-fusion,duringdeliveryorwhendeliveryispaused.

LOCK

NCONC 0.5 mg/mL TVD 0.005 mLWEIGHT 5 KGDOSE 6 MCG/KG/MIN RATE 3.6 mL/hr


DOBUTamine 0.5 mg/mL PICU

Changing rate during deliveryTheinfusionratecanbechangedduringanydeliv-erysession,exceptwhenusingIntermittentdeliverymodes.

1. Fromanydeliveryscreen,pressCHG Rate(orCHG Dose).

2. TheEnter Ratescreenappears.Infusion does not stop.Thecurrentsettingcontinuestobedelivereduntilthenewrateisentered.Notethecurrentsettingisalwaysshowninthetopofthedisplay.

3. Usethenumberkeystosetthedoserate.Rateislimitedbythemaximumandminimumdeliveryrateforsyringesize.

Ifyoudecideyoudon’twanttochangetherate,pressâ.ThedeliveryratedoesnotchangeuntilEnterispressed.

4. WhenthedesiredrateisdisplayedpressEntertoacceptthenewsetting.(ThenewrateisnoteffectiveuntilEnterispressed.)

BACKSPACE ENTER


HIGH: 944

LOW: 0.1

CLEAR

mL/hr4060 CURRENT SETTING


95

Changing the rate when pausedThedosageratecanbechangedatanytimethepumpispaused:

1. WiththepumppausedattheBegin Infusionscreen,pressChg Rate(orChg Dose).

2. Usethenumberkeystochangethedeliveryrate.Rateislimitedbythemaximumandminimumdeliveryrateforsyringesize,orbycustomsettingsintheconfiguration.ThedeliveryrateentrydoesnotchangeuntilEnterispressed.Exitwithoutchangingtheratebypressingâ.

3. WhenthedesirednewrateisdisplayedpressEntertoacceptthenewsetting.

4. ThepumpispausedattheBegin Infusionscreen.Whenreadytorestarttheinfusion,pressÉ.


PRESS < « > TO BEGIN INFUSION PVD 0.429 mLBOLUS 2.5 mL V LIMIT 60 mL KVO RATE 0.6 mL/hr RATE 3.5 mL/hr

CHG RATEMAIN MENU

BACKSPACE ENTER


HIGH: 944

LOW: 0.1

CLEAR


BACKSPACE ENTER


HIGH: 944

LOW: 0.1

CLEAR


G6000912 Rev 0

PRIME / BOLUS


96

Total volume, program volume / dose delivered

TheMedfusion®Model4000pumpmonitorsandmaintainsthetotalquantityoffluidsbeingdeliveredduringanygivensessionofinfusions.TotalVolumeDelivered(TVD)isdisplayedatthetopofthescreen.TheTVDisthetotalvolumedeliveredtothepatient,accumulatedovermultipledrugprogramsandinfu-sions,andit will continue to accumulate untilClear TVD (orClear Totals)is pressed or the pump is turned off.TVDcanberecalledusingtheRecallLastSettingsfeature(seepage57).

Displaying “Program Volume Delivered” (PVD) / “Program Dose Delivered” (PDD)

Inmostdeliverymodes,youhavetheoptionofview-ingeither“Program Volume Delivered”or“Program Dose Delivered”.Onthedisplay,PVDorPDDaccumulatesasthevolumeordoseisdeliveredtothepatient,andac-cumulatesfor the current infusion only. PVD/PDDisautomaticallyclearedwhentheinfusionendsandthepumpisreturnedtotheMainmenu,andcanbeclearedbypressingClear Totals.Thisdisplaytotalstheboluses,loadingdose,andnormaldeliveryvol-umes.

• Priming volume –Which should never be deliv-ered to the patient–does notaccumulateonthisdisplay.

• Program volume or dose delivered –AppearsonscreenwhilethepumpispausedandduringDeliveryforthefirstthreesecondsandbrieflybypressingâ.

• Program Dose Delivered −Onlyavailablewhenconcentrationhasbeenprogrammed.

• Toggle from PVD to PDD –AvailablethroughOptionsmenu(providedthisoptionhasbeenenabledforuse).Seepage81forinstructionsonusingthisoption.

OPTIONS CLEAR TOTALSCHG DOSEMAIN MENU


DOSE 15 mcg/kg/min RATE 4.5 mL/hr

b-d 20mL

OPTIONS CLEAR TOTALSCHG DOSEMAIN MENU

CONC 1000 mcg/mL PDD 0.113 mcgWEIGHT 5 KG

DOSE 15 mcg/kg/min RATE 4.5 mL/hr

b-d 20mL

LOCK

NCONC 1000 mcg/mL TVD 0.414 mLWEIGHT 5 kgDOSE 15 mcg/kg/min RATE 4.5 mL/hr


DOBUTamine 1000 mcg/mL

≥

NICU


97

Clearing total volume, program volume, or program dose deliveredUsethefollowingstepstoclearthetotalvolumeandprogramvolume(ordose)andresetthecountertozero.

With the pump paused (press á, if necessary):1. PressClear Totals.

2. Confirmationisrequiredtocleartotalsdelivered.PressYestocleartotalvolumedeliveredandprogramvolume(ordose)de-livered.(OrpressNotoexitwithoutclear-ing.)

Theprogramvolume(ordose)deliveredisclearedautomaticallywheneverthepump’sdeliverymodeischanged.TheTotalVolumeDeliveredisonlyclearedwhenthesoftkeyispressed(i.e.,Clear Totalskey).


PRESS < « > KEY TO BEGIN INFUSIONCONC 1.2 mg/mL PVD 0.000 mLWEIGHT 50 KG

DOSE 2.5 MCG/KG/MIN RATE 3.5 mL/hrCHG DOSEMAIN MENU

NO

CLEAR TOTAL VOLUME DELIVERED?

YES

With the pump delivering:1. Fromanyrunscreen,pressClear TVD.

2. ConfirmationisrequiredtocleartheTotalVolumedelivered.PressYestocleartotalvolumedeliveredonly.(OrpressNotoexitwithoutclearing.)

Theprogramvolume(ordose)deliveredisclearedautomaticallywheneverthepump’sdeliverymodeischanged.TheTotalVolumeDeliveredisonlyclearedwhenthesoftkeyispressed(i.e.,Clear Totalskey).

Recovering TVD / TDD Information:TheTotalvolumedelivereddisplaycanberestoredafterturn-ingthepumpoffbyusingtheRecall Settingsselec-tionfromtheMainmenu.IfTVDhasbeencleared,thenonlythequantityinfusedsinceclearingwillbestoredinmemory.ItmaybegoodpracticetomakenoteofTVDbeforeclearingit.

LOCK

N PVD 5.048 mL KVO V LIMIT 60 mL

RATE 3.5 mL/hr

B-D 60mL

CHG RATE CLEAR TVD

NO

CLEAR TOTAL VOLUME DELIVERED?

YES


98

Keypad lock Thekeypadcanbelockedduringdelivery.Thelockfeatureisprovidedtomakethedeliverysettingstam-perresistant.Oncethekeypadislocked,asettingcannotbemodi-fieduntilthekeypadisunlocked.TheMedfusion®Model4000pumpoffersaprogrammableunlockcodeoptionsetthroughcustomconfiguration.Any high-priority alarm automatically unlocks the front panel.

1. PressLocktolockthefrontpanelcontrols.

TheLockindicatoronthefrontpanellights.

2. IfanyfrontpanelkeysotherthanUnlockarepressed,a“Pump is Locked”messageappearsonscreen.

3. PresstheUnlockmenukeytounlockthefrontpanel.IfanUnlockPasscodehasbeenset,youwillbepromptedtosupplythepasscodebeforethefrontpanelwillunlock.

G6000912 Rev 0

PRIME / BOLUS

BACKSPACE ENTER

ENTER UNLOCK PASSCODE - PRESS ENTER TO CONTINUE

HIGH: 9999

LOW: 0

CLEAR

PVD 0.025 mL

RATE 4.5 mL/hrLOCK

N


100%B-D 60mL

OPTIONS CLEAR TVD

PUMP IS LOCKED

PVD 0.030 mL

RATE 4.5 mL/hr

CHG RATEUNLOCK

N


99

Alarms & remediesTheMedfusion®Model4000pumphasnumerousalarmsbuiltintoit.Thesearetriggeredbysituationsasameansofwarningoradvisingyousomethingisnotfunctioningwithinnormalparameters.Pumpalarmsareloggedintothepump'sAlarm History(viewableintheBiomedmenu,andmaybeincludedinvariousreportsviaPharmGuard®Toolbox2and/orthePharmGuard®Server).Alarms / alerts typesBelowisatableofthealarmsandalertsgeneratedbythepump,includingdefinitionsandremedies:

Type Definition and RemedySystem Fault priority

ASystem Fault alarmisinitiatedwhenoneofthesystemfaultconditionsoccur.Fluiddeliverystops.SystemFaultalarmsaresignaledwithaflashingredindicator,repeatingaudiblesignalandaviewingscreenbacklightthatoscillatesbetweenbrightanddim;thepumpwillreturntotheMainmenuandshowtheBiomedmenuastheonlychoice.Press í to silence the audible alarm, then press ë to turn the pump off.ThereisnoothermethodforendingaSystem Faultalarm.Ifthealarmpersistswhenthepumpisturnedbackon,oriftheMainmenushowsonlytheBiomedmenu,thepumpmustberemovedfromserviceforinspectionandrepairbyatrainedbiomedicaltechnician.IfthefrontpanelcontrolsarelockedwhenaSystemFaultalarmoccurs,thepumpcontrolsdounlock.Note:Systemfaultsmayresultinsubsequentfaultsbeingloggedinthepump'sAlarm History,howeveronlytheinitialfaultisdisplayedonthepump(duetothefactthattheonlymethodforendingthealarmistoturnthepumpoff).

High priority Ahigh-priority alarmisinitiatedbyanyconditionthathaltsanongoinginfusion.High-priorityalarmsaresignaledwithaflashingredindicator,aviewingscreenbacklightthatoscillatesbetweenbrightanddim,andarepeatingaudiblesignal.Pressítoreturntheviewingscreenbacklighttobrightandsilencetheaudiblealarmfortheprogrammedalarmsilenceperiod.Duringahigh-priorityalarmcondition,allkeysexceptíarelocked.You must silence the alarm by pressing í before any other action can be taken.Ifthefrontpanelcontrolsarelockedwhenahigh-priorityalarmoccurs,thepumpcontrolsdounlock.Ahigh-priority alarmthatstopsdeliveryduringaloadingdoseorboluswillnotreturntotheBegin Deliveryscreenuntilthealarmissilenced–thisallowsyoutorecordtheportionoftheloadingdose/bolusvolumedeliveredpriortothealarmsounding.

Medium priority Amedium-priority alarmindicatesanyconditionrequiringinterventionbutdoesnothaltinfusion.Medium-priorityalarmsaresignaledwithaflashingyellowindicator,aviewingscreenbacklightthatoscillatesbetweenbrightanddim,andarepeatingaudiblesignal.Pressingíwillreturntheviewingscreenbacklighttobrightandsilencetheaudiblealarmfortheprogrammedalarmsilenceperiod.Duringamedium-priorityalarmcondi-tion,allkeysexceptíarelocked.You must silence the alarm by pressing í before any other action can be taken.Ifthefrontpanelcontrolsarelockedwhenamedium-priorityalarmoccurs,thepumpcontrolsdo notunlock.


100

Type Definition and RemedyLow priority Alow-priority alarmindicatesanyconditionnotrequiringimmediateoperatorinterven-

tion.Low-priority alarmsareannouncedwithacontinuousyellowindicator,aviewingscreenbacklightthatoscillatesbetweenbrightanddimandanon-repeatingaudiblesignal.Duringalow-priorityalarmcondition,allkeysexceptíarelocked.You must silence the alarm by pressing í before any other action can be taken.Ifthefrontpanelcontrolsarelockedwhenalow-priorityalarmoccurs,thepumpcontrolsdo notunlock.

Limit priority Alimitpriorityalarmprovidesuserfeedbackrelatedtointeractionwiththepump.Note:TheaudiopartofLimitpriorityalertistiedto“KeyClickloudness”,whichissetinPharmGuard®Toolbox2.IfkeyclickloudnessissettoOff,therewillbenoaudibletoneaccompanyingLimitpriorityalerts(visualalertswillstillappearinthedisplay).Thevol-umewillotherwisesoundattheloudnesslevelselectedforkeyclicks-Level2(quietest),Level3,Level4,orLevel5(loudest).Alimit-priority alarmsoundsathreetone,non-repeatingaudiblesignalanddisplaysanadvisorymessageonscreenfor3seconds.Ifthefrontpanelcontrolsarelockedwhenalow-priorityalarmoccurs,thepumpcontrolsdo notunlock.

Re-displaying an alarm messageWheneveranalarmissilenced,thealarmmessageremainsonthescreenforapproximately3seconds.Thismessagecanbere-displayedforanadditional3secondsbypressingí.


101

“User Callback” alarm The“User Callback”alarmisaMediumpriorityalarmthatservesasaremindertofinish what you started.Onceyoubeginprogramminganyinfusiondelivery,thepumpexpectsyoutocontinueuntilsetupiscom-plete.Ifthepumpispausedtoolong(30seconds)afteraprofileisselectedoronadataentryscreen,thepumpinitiatesthisalarm.Thereareseveralbasicresolutions:

stoppingtheinfusion.The“Syringe Near Empty”alarmtimemaybesetandisusefulinallowingpreparationtimeforthenextsyringeoncontinuousinfusions.Thisalarmindi-catesthetimeremainingtothe“Syringe Volume Near Empty”alarm.The“Syringe Volume Near Empty”alarmprovidesindicationthatthesyringeisnearlyempty.There-mainingtimetothe“Syringe Empty”alarmisvariabledependingonsyringedimensionalvariation.

“Syringe Near Empty” alarmTheSyringe Near EmptyalarmisaMediumorLow priority alarmthatoccursindicatingthatthesyringewillreachemptyinthe“NearEmptyTime”interval.The“NearEmptyTime”intervalrangesfrom1-240minutes.Thistimeintervalmaybesetviathe“NearEmptyTime”PharmGuard®Toolbox2settingaswellasthealarmpriority,LoworMedium.

Note:Ifthe“NearEmptyTime”isgreaterthanorequaltotheinfusiontime,theSyringe Near Emptyalarmwillsoundassoonastheinfusionisstarted.Thepumpsoundstherespectivepriorityalarmtone,displaysthenearemptyalarmmessageonscreen,but does not stop delivery.Pressingíwhenthisalarmisactivesilencesthealarm.The“SyringeNearEmpty”alarmoccursonlyonceiftheinfusionisallowedtocontinueuntilitstopsduetoan“EndofInfusion,”“SyringeEmpty,”orsomeotheralarm.

LOCK

NCONC 1.2 mg/mL PVD 13.81 mLWEIGHT 50 KG BOLUSDOSE 20 MCG/KG/MIN RATE 50 mL/hr


SYRINGE NEAR EMPTY

• PressANYkeytosilencethealarmforanother30seconds.

• GototheBegin Infusionscreen.Therethealarmsilenceintervalisonetotwominutes,dependingontheconfiguration.

• UsetheStandbyoptiontopreventtheUserCallbackalarmwhilepausedattheBegin Infusionscreen.

• PressÉtobegintheinfusion.• CanceltheinfusionandreturntotheSelect

the Profilescreen,wherenoalarmssound.• Press&holdëandturnthepumpoff.

Syringe Empty Alarm ProcessSensingforanemptysyringecanbeamulti-stepprocessontheMedfusion®Model4000pump.The“Syringe Near Empty”alarmand“Syringe Volume Near Empty”alarmsarebothcalculatedbythepump,basedoninfusionvolumeandtime,andaredesignedtoindicatethesyringeisnearingemptysothereistimetoprepareforanothersyringe,ifneeded.The“Syringe Empty”and“Syringe Empty - Stop”alarmsarethefinalalarmsintheprocess,stoppingfluiddeliverywhenthesyringeisempty.The“Syringe Near Empty”alarmtimeiscalculatedbasedontheflowrateandsyringevolumetooccuratthesetamountoftimebeforethe“SyringeVolumeNearEmpty”alarm.The“Syringe Volume Near Empty”alarmoccursatasyringepositionneartheendofthesyringetravel.Duetovariationinsyringedimensions,thepumpwillcontinuetoinfuseforavariableamountoftimeuntilthesyringeplungerreachestheendofthesyringeandthe“Syringe Empty”alarmsounds

1. Pressítoclearthealarmmessage.2. Confirmhowlongbeforetheinfusionends.3. Ifnecessary,prepareanewsyringetoloadonto

thepumpandthenstartanewinfusion.

“Syringe Volume Near Empty” alarmTheSyringe Volume Near EmptyalarmisaMedium priority alarmindicatingthatthesyringehasreachedthesyringe position“VolumeEmpty”.Duetosyringe


102

“Syringe Empty” alarmTheSyringe Emptyalarmisahigh priority alarmadvisingthesyringeisempty.TheEmptyalarmstopsdeliveryimmediately.

System Advisory - Maintenance is RecommendedIfyourorganizationhassetupapreventivemainte-nancepolicyfortheMedfusion®Model4000pumpandprogrammedapreventivemaintenancereminderintheBiomedmenu,aspecialalertisadded.Whenitistimeforapreventivemaintenanceinspection,eachtimethepumpisturnedonSystem Advisory : Maintenance is RecommendedappearsatthetopoftheMain Menu.Pressítosilencetheaudiblealarmandsendtopumpformaintenanceassoonaspractical.Thisalertwillrecureachtimethepumpispoweredupuntilatrainedbiomedicalservicetechni-cianhasresetit.

MORE

SYSTEM ADVISORY - MAINTENANCE IS RECOMMENDED 1 NICU2 PICU3 GeneraL4 AneStheSia

System FailuresSystemFailurealarmsmayindicateaproblemwithpumphardwareorsoftware.Occasionally,turningthepumpoff,thenbackonwillclearthefault(seethepagesthatfollowforspecificinformation).Ifthealarmpersistswhenthepumpisturnedbackon,thepumpmustberemovedfromuseandcheckedbyatrainedbiomedicalservicetechnician.Ifthepumpexperiencescertainsystemfaults,ascreenrequiringentryofaBiomedPasscodewillappear.Ifthisscreenappears,immediately remove pump from serviceforinspection/repairbyatrainedbiomedicalservicetechnician.

1. Pressítoclearthealarmtone&message.2. Unloadthesyringe.3. Iftheinfusioniscompleteeitherturnthepump

offorprepareforanotherinfusion.Iftheinfu-sionisnotcomplete,prepareandloadanothersyringeand:

•returntotheSelect the Profilescreen(wherenoalarmssound)orturnoffthepump.OR

•ifthemodeinusewasacontinuousinfu-sion,thescreendisplaysContinue Same Infusion?,withchoicesofContinueorRestart.Continueorrestarttheinfusion,orturnthepumpoff.

variationtheremaystillbearesidualvolumeofmedi-cationinthesyringe;thereforetheinfusioncontinues.

1. Pressí.2. Ifyoudo notwishtodeliveranyremainingfluid,

orifthesyringeisempty,pressáandunloadthesyringe.Eitherprepareandloadanothersy-ringe,returntotheSelect the Profilescreen(wherenoalarmssound),orturnthepumpoff.

3. Thepumpcontinuesdelivery,andcontinuesuntilnofluidremainsinthesyringe.

4. Assoonasthesyringeplungerreachestheendofthesyringe,ithaltsdeliveryanddisplaysthe“Syringe Empty”messageonscreen.

5. Pressí.(ThepumphasstoppeddeliveryandisattheBegin Infusionscreen.)

6. Eitherprepareandloadanothersyringe,returntotheSelect the Profilescreen(wherenoalarmssound),orturnthepumpoff.

Monoject® 1, 3, 12 and 35 mL:Becauseofvaria-tionsinsyringemanufacturing,theMonoject®1,3,12and35mLsyringesmayinsomecasesnotfullyempty.Here,theemptyalarmsoundswithsomefluidleftinthesyringe.


103

General system alarms & alertsThissectioncontainsatableofthegeneralsystemalarms,listedalphabetically,whichmaybeencoun-teredwhileoperatingtheMedfusion®Model4000pump.Thistableidentifiesthealarmbymessageandtype,andprovidesadefinitionandpossibleremedies.

WARNING: Ifasystemfailurealarmoccursandcan-notbeclearedbypoweringthepumpdownthenbackup,thepumpcannotbeused.Removeitfromuseandsendittoatrainedbiomedicaltechnicianforservice.

Alarm Message Priority RemedyCalculated Rate Out of

RangeHigh Basedonthevaluesentered,thepumphascalculatedaratethatisnot

validandcannotbedeliveredbasedonphysicallimits(suchassyringeparameters).Pressí.Verifythatallinfusionparametershavebeenenteredcorrectly.IftheinvalidcombinationispartofaDrugProgram,contactyourPharmGuard®Toolbox2Administrator,whowillhavetoreviewandcorrecttheproblem.

Check Clutch / Plunger Lever

High Thepumphassensedthattheplungerdriverisnotmovingcorrectly.ThismaybecausedbyavarietyofissuessuchasthePrimefunctionwasnotusedbeforestartingdelivery(leavingslackinthedrivesystem),theplungerleversaremoved,theclutchisnotproperlyengaged,orthereisaproblemwiththepumphardware.Pressíandchecktheplungerleverandensurethelevermovesfreelyandiscapturingthesyringeplunger.AlwaysusethePrimefeaturewhenloadinganewsyringe.Ifthealarmpersists,removethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

Check Syringe Barrel Clamp

Medium Certainsyringemodelsandsizesmaycausethebarrelclampsensortohavedifficultyinverifyingtheclampisinposition.Whenthisalarmoc-curspressí,verifythatthebarrelclampisindeedinplace,thenpressConfirm.OR Whenthepumpwaspoweredup,thesyringebarrelclampwasliftedupandrestingonthepumphandle.Whenthesyringemodelisselected,thisalarmoccurs.Pressí,pressConfirmandcontinueloadingthesyringe.Ensurethatthesyringebarrelclampisproperlypositionedonthesyringebarrel.

Check Syringe Flange Sensor

High Sensorisactivewhenasyringeisnotloadedcorrectly.Checkthesy-ringeflangeholder.Ensurethesyringebarrelclamp,flangeholder,andplungerholdersareproperlyengagedandtheflangeholderpullsbacktothesideofthecase.Ifholderdoesnotoperatecorrectlyorthealarmper-sists,immediatelyremovethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.


104

Alarm Message Priority RemedyCheck Syringe Plunger

SensorHigh Sensorisactivewhensyringeisnotloadedcorrectly.Checkthesyringe

plungerholders.Ensurethesyringebarrelclamp,flangeholder,andplungerholdersareproperlyengagedandtheholdersmovefreely.Iftheydonotoperatecorrectlyorifthealarmpersists,immediatelyremovethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

Data Does Not Match Previous Entry

Limit Incaseswhereconfirmationofentereddataisrequired,theconfirma-tionvaluedidnotmatchtheoriginallyprogrammedvalue.Re-enterthecorrectvalue.

Force Sensor Bgnd Test High Aself-testwasperformedontheforcesensor,andthetestfailedduetoasensormalfunctionORtheSyringePlungerDriverwasbeingmovedduringthepumpstartupprocess,oriftheSyringePlungerDriverre-ceivesahardbumpduringthepumpstartupprocess.Pressí.Pressëtoturnthepumpoff.Immediatelyremovethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

Infusion Complete High Theprogrammedinfusion(baseduponthevaluesenteredinthepump)hasbeendelivered.Pressí.Eitherbeginanewinfusion,returntotheSelect The Profilescreen(wherenoalarmssound),orturnoffthepump.

Input Out of Range - Greater Than Max Minutes

(Seconds)

Limit Thetimevalueenteredisgreaterthanthemaximumallowedfortheminutesorseconds.Pleasetryalowervalue.

Input Out of Range - Greater Than Max Value

Limit Thevalueenteredisgreaterthanthemaximumallowedfortheitem.Pleasetryalowervalue.

Input Out of Range - Less Than Min Value

Limit Thevalueenteredislessthantheminimumallowedforthisitem.Pleasetryahighervalue.

Invalid Entry Limit Thereisaproblemwiththedrugprogramselected,andthepumpcan-notdeliverit.ContactyourPharmGuard®Toolbox2Administrator,whowillhavetoreviewandcorrecttheproblem.

Invalid Infusion Parameter Combination

Low Thecombinationofinfusionparametersdoesnotallowavalidflowratetobecalculated.Verifyallinfusionsettings.Iftheinvalidcombina-tionispartofaDrugProgram,contactyourPharmGuard®Toolbox2Administrator,whowillhavetoreviewandcorrecttheproblem.

Invalid Syringe Size High Syringesizenotrecognizedforthemodelselected,orthesyringebarrelclampwasliftedduringdelivery.Reviewsyringesizesinthetechnicalspecificationssection,anddonotliftthesyringebarrelclampduringdelivery.Ifthealarmpersists,removethepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

KVO in Progress Medium InformationalmessagethatvolumelimithasbeenreachedandKVOinfusionisinprogress.Pressí.

Limits Adjusted - Cannot Deliver All Doses

Limit ThePharmGuard®Toolbox2specifiedsoftlimitvaluesandsyringespecifiedduringprogrammingwouldallowvaluestobeenteredthatresultinarateoutsidetheallowablelimits.Thepumphasadjustedthelimitstokeeptherateinsideallowablelimits.Verifythevaluesenteredandthesyringesize.


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Alarm Message Priority RemedyMotor Not Running High Themotorisnotrunning,whichmaybeduetoanerroneous(possibly

transient)sensorsignal,oramechanicaland/orelectricalfailure.Pressí.Pressëtoturnthepumpoff,thenbackon.Ifthealarmpersistswhenthepumpisturnedbackon,immediately remove the pump from serviceforrepairbyatrainedbiomedicalservicetechnician.

Motor Rate Error High Themotorisnotrunningattheprogrammedrate,whichmaybeduetoanerroneous(possiblytransient)sensorsignal,oramechanicaland/orelectricalfailure.Pressí.Pressëtoturnthepumpoff,thenbackon.Ifthealarmpersistswhenthepumpisturnedbackon,immediately remove the pump from serviceforrepairbyatrainedbiomedicalservicetechnician.

Occlusion - Check Infusion Line

High Checkinfusionlineforblockage.Clearorremedyanydiscoveredocclu-sion;forexample,checktheinfusionsetforclosedstopcocks,clamps,checkthetubingforkinks,verifythepatencyofthetubingandtheIVsite,etc.PressÉtorestartinfusiononceocclusionislocatedandcleared.Ifthisalarmoccursfrequentlyandyouhaveruledoutanac-tualocclusion,theinfusionsettubingmaybetoosmallfortherateorfluidviscosity,youmaywanttoconsiderenablingflowsentry,oryoumaywanttoconsiderchoosingadifferentocclusionalarmsettingintheConfiguration.Ifyoucannotcleartheocclusionalarm,theremaybeaproblemwiththepumpthatrequiresrepairbyatrainedbiomedicaltechnician.

Outside Range Limit - Silence Alarm to Continue

Medium TheenteredrateisoutsideoftheDrugProgramsoftlimits.Pressítocontinue.Youmaythenchoosetooverridetherangelimitorchangethevalueentered.

Periodic Callback - Silence Alarm to Continue

Medium Pressí.Userprogrammedcallbackalarm-noremedyrequired.

Pressure Increasing - Check Infusion Line

Medium Pressí.FlowSentry™detectsincreasingpressureintheinfusionline.Checkinfusionlineforblockage;forexample,checktheinfusionsetforclosedstopcocks,clamps,checkthetubingforkinks,verifythepatencyofthetubingandtheIVsite,etc.Clearorremedyanydiscoveredocclu-sion.Ifocclusionisnotcleared,the“Occlusion”alarmwillresult.

Profile Does Not Match Last Settings Profile

Limit Theuserattemptedtousethe“RecallLastSettings”feature.RecallLastSettingsonlyworksifthepumpisinthesameprofileunderwhichthepreviousinfusionwasprogrammed.

Pump is Locked Limit Thekeypadhasbeenlockedtopreventchangesduringinfusion.ThealarmisinitiatedbypressinganykeyexceptUnlock.PressUnlocktomakechangestodeliverysettings.

Rate Below Recommended Min for

Syringe Size

Limit Remindsyouthattheprogrammedrateisbelowthatrecommendedforthesyringesize-noremedyrequired(seeGuidelines for enhanced pump performance,page24).

Restricted Flow - Bolus Cancelled

Medium Bolusdeliverywascancelledbeforecompletion.Whilethepumpwasdeliveringabolus,theflowratewasrestrictedandinitiatedratereduc-tion,whicheventuallyfellbelowthemaininfusionrateorextendedpastthemaximumbolustime.Checktheinfusionlineforocclusion.


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Alarm Message Priority RemedyRestricted Flow - Loading

CancelledMedium Loadingdosedeliverywascancelledbeforecompletion.Whilethepump

wasdeliveringaloadingdose,theflowratewasrestrictedandinitiatedratereduction,whicheventuallyfellbelowthemaininfusionrateorextendedpastthemaximumloadingdosetime.Checktheinfusionlineforocclusion.

Restricted Flow - Rate Reduced

Medium Ifthebolusorloadingdoserateishighenoughtotriggeranocclusionalarm,thesoftwarereducestherateuntilthebolus/loadingdoseissuc-cessfullydeliveredor,iftheratefallsbelowacertainlevelortakeslongerthanthepumpallows,iscancelled.Witheachratereduction,thispro-cessrepeats.Oncesilenced,theaudiblealarmtonewillnotreactivate,eveniftheprocessrepeats.

Set Volume Limit Before KVO

Limit ProgrammingofaKVOratewasattempted,butthereisnovolumelimitset.Programavolumelimit,thensetaKVOrate.

Syringe Does Not Match Entry

Limit Thedrugprogramindicatesaspecificsyringe,andthesyringeinuseisdifferent.Verifythecorrectdrugprogramandsyringearebeingused.

Syringe Empty High Pressí.Thesyringeisnowempty.Either: • Prepareandloadanothersyringe. •ReturntotheSelect the Profilescreen,wherenoalarms

sound. •Turnoffthepump.

Syringe Empty - Stop High Pressí.Thepumphaseithercalculated(basedonthesyringemodelinuse)thatthesyringeshouldbeatit'sforward-mosttravelpoint,orthepump’sSyringePlungerDriverhasmovedasfarforwardasispossible.Either: • Prepareandloadanothersyringe. •ReturntotheSelect the Profilescreen,wherenoalarms


Syringe Flange Not in Place

High Pressí.Thesyringeisnotloadedcorrectly,orthesensorhasfailed.Makesurethesyringeflangeisproperlyinsertedintotheflangeclip.Proceedwiththeinfusion,ifpossible.Ifthealarmrecurs,removethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

Syringe Near Empty MediumorLow*

Thepumpisindicatingthesyringewillsoonbeempty.The“NearEmptyTime”intervalrangesfrom1-240minutes.Thistimeintervalmaybesetviathe“NearEmptyTime”inPharmGuard®Toolbox2,aswellasthealarmpriority,LoworMedium.

Syringe Plunger Not in Place

High Pressí.Thesyringeisnotloadedcorrectly,orthesensorhasfailed.Makesurethesyringeplungerheadisproperlyinserted.Proceedwiththeinfusion,ifpossible.Ifthealarmrecurs,removethepumpfromser-viceforrepairbyatrainedbiomedicalservicetechnician.


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Alarm Message Priority RemedySyringe Volume Near

EmptyHigh Pressí.Thepumphascalculatedthatthevolumeofmedicationinthe

syringeisnearlyempty.The“SyringeEmpty”Alarmwillactivatewhenthesyringeisempty.Makepreparationstoinstallanewsyringe,ifneces-sary.Thetimeuntilthesyringeisemptycanbeestimatedbyestimatingthevolumeremaininginthesyringeanddividingbythedeliveryrate.

User Call Back Medium Thepumpwasleftidleonauserinputscreen.Either: • Finishtheprogrammingsteps. •ReturntotheSelect the Profilescreen,wherenoalarms


*“SyringeNearEmpty”alarmpriorityisconfigurableseparatelyforeachprofileusingPharmGuard®Toolbox2.

System Failure and Advisory AlarmsBattery Alarms

Alarm Message Priority RemedySystem Advisory :

Battery Communication Timeout

Medium Theinternalbatteryisnotworking.ThepumpmaybeusedonACpoweronaconditionalbasis.Assoonaspossible,removepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Advisory : Battery Not Working

Medium Theinternalbatteryisnotworking.ThepumpmaybeusedonACpoweronaconditionalbasis.Assoonaspossible,removepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Failure : Depleted Battery

SystemFault

Pressëtoturnthepumpoff.Thebatteryiscompletelydrained.PlugintheACpowercord,thenpressëtoturnthepumpon.Untilthebat-teryisallowedtorecharge,thepumpcanonlybeusedifconnectedtoACpower.

System Advisory :

Low Battery

MediumorLow

Initial:Indicatesbatteryislow,andneedschargingsoonorthepumpwillnotbeabletocontinuedelivery.Pressí.Ifpossible,pluginpowercordandrunpumponACmainswhilerechargingthebattery.Asanadditionalreminder,foreach1%dropincapacityaftertheinitialLowBatteryalarm,theLowpriorityLowBatteryalarmwillsound.Ifthepumpisnotpluggedin,theamberalertLEDwillblinkatthesamerateasthebatteryindicatorLEDuntiltheSystem Failure - Battery Depletedalarmoccurs(asavisualreminderthatthebatteryislow).


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System Failure Alarms

Alarm Message Priority RemedySystem Failure :

Control Key Switch BGND Test

SystemFault

Eitherakeyonthekeypadhasbeenpressedforlongerthan7seconds,orthekeypadneedstobereplaced;fluiddeliverystops.Pressëtoturnthepumpoff,thenturnitbackon.Ifthealarmpersistswhenthepumpisturnedbackon,immediately remove pump from serviceforrepairbyatrainedbiomedicaltechnician.

System Failure: Configuration Required

SystemFault

ThepumphasdetectedthatavalidConfigurationisnotinstalledandthepumpcannotoperate.ApossiblecauseofthisalarmisthatafirmwareupdateandaConfigurationweresenttothepumpatthesametime,andwhenthefirmwareupdatewasinstalledfirst,theConfigurationbecameincompatibleandsowasdeleted.Ifthisisthecase,sendanewConfigurationtothepump.Thenturnthepumpoff,andatthepromptsinstallthenewConfiguration,thenturnthepumpbackon.Ifthisisnotthecause,removethepumpfromserviceforrepairbyatrainedbiomed-icaltechnician.

System Failure : xx xx xx

SystemFault

Where“xx xx xx”indicatesadditionaltextforthespecifictypeoffailure.ThepumpdisplayshowstheMainmenu,withonlytheBiomedmenuavailable.Somesystemfailuresresultinahardware“watchdog”alarmwhichresultsinanalarmtonesounding(andmayormaynotbeaccom-paniedbyaflashingredalarmindicator).Pressëtoturnoffpump,thenbackon.Ifthealarmpersistswhenthepumpisturnedbackon,immediately remove pump from serviceforrepairbyatrainedbiomedi-caltechnician.

System Advisory AlarmsAlarm Message Priority Remedy

System Advisory : Base Hardware Failure

Medium Thebasehasdetectedahardwarefailure(thespecificcodeisinthefailedvalue).Assoonaspossible,removethepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Advisory : Base Not Responding

Medium Thepumpbasehasexperiencedahardwareorsoftwarefailure.Assoonaspossible,removepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Advisory : Base Unknown Failure

Medium Thebasehasanunknownhardwarefailure.Assoonaspossible,removethepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Advisory : Configuration Invalid

Medium TheConfigurationdataisinvalidduetouseractionorcorruption.ThepumpstoresacopyoftheConfigurationinthebase,whichcanbeap-pliedtorestoreit.Pressëtoturnthepumpoff,andatthepromptap-plytheupdate.Pressëtorestartthepump.TheConfigurationshouldnowberestoredforuse.

System Advisory : Improper Shutdown

Low Thepumpimproperlypowereddown.Assoonaspossibleremovepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Advisory : KB Data Integrity Failure

Medium Thenetworksettingsarecorrupt.Assoonaspossible,removepumpfromserviceforrepairbyatrainedbiomedicaltechnician.


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Alarm Message Priority RemedySystem Advisory :

Maintenance is Recommended

Low ThescheduledPreventiveMaintenanceisdue.Assoonaspossible,re-movepumpfromservicefortestingandcheckoutbyatrainedbiomedi-caltechnician.Thisalarmwillreactivateeachtimethepumpispoweredonuntilserviceisperformed.

System Advisory : Network Configuration

Reset

Medium ThenetworkconfigurationresetcommandhasbeenexecutedintheBiomedmenu.Noactionrequired.

System Advisory : Set Time and Date

Low Thepump'sTimeandDatesettingshavebeenlost.Assoonaspossible,removepumpfromservicefortestingandcheckoutbyatrainedbio-medicaltechnician.

System Advisory : xx Data Corrupted

Low Infusionwillcontinueusingbackupcopyofxx data(wherexxrepre-sentsvariabletextindicatingthespecificdatathatiscorrupted).Assoonaspossible,removepumpfromservicefortestingandcheckoutbyatrainedbiomedicalservicetechnician.


110

Note:Ifapumpisoperatingonbatterypower,andthebatteryhas10%orlessremainingcharge,theUpdateNotificationwillnotactivate.Thisisbecausewithlessthan10%chargeitispossiblethatthebatterywillbedepletedbeforetheupdatecanbecompleted.

1. Pressëtoturnthepumpoff.2. Toinstalltheupdate,pressEnter.Toexitthe

screenwithoutinstallingtheupdate,eitherpressëagainorwait 60 seconds for the pump to turn off automatically without installing the update.

3. TheLearningprogressisthenshownonthepump’sdisplay.

DONOTpressëoranyotherkeyuntiltheupdatefinishes.

4. Whentheprocessiscomplete,thepumpautomaticallyturnsoff.Inrarecases,thepumpwillcompletetheupdateandthen,at0percentremaining,a“watchdog”systemfailurewilloc-cur.Turningthepumpoff,thenbackonshouldclearthisconditionandmakethepumpreadyforuse.

5. Validatetheupdateiscorrectlyinstalledwhenthepumpisnextturnedon(onthepump’sstartupscreen,theversionnumbermatchesthatshowninPharmGuard®Toolbox2,andtheConfigurationCRCmatchestheonedisplayedontheTeachProgressscreen(inPharmGuard®Toolbox2;ifunsurewhattheversionnumberandCRCshouldbe,contactyourPharmGuard®Toolbox2Administrator,orfollowyourvalida-tionprotocol).

AVAILABLE UPDATE MAY TAKE UP TO 5 MINUTES TO FINISH EITHER PRESS <ENTER> TO BEGIN UPDATE OR PRESS <POWER> AGAIN TO SHUT DOWN NOW. OTHERWISE PUMP WILL SHUT DOWN IN 60 SECONDS.

ENTER

CONFIRM SYSTEM UPDATE

78% REMAINING

LEARNING CONFIGURATION




Configuration Version and CRC numbers

Pump Software Version

Update(s) Available NotificationWhennewConfigurationsorpumpsoftwareareavailableandhavebeen“taught”orsenttoapump,thenexttimethepumpisturnedoffascreenappearsindicatingthereisanupdateavailableforinstallation.

Important:Thereshouldbeawell-definedreviewandtestprocessperformedbeforeinstallingaConfigura-tionontopumpsforusewithpatients.TheConfigura-tionshouldbedeveloped,senttoseveraltestpumpsforvalidationandthenapprovedviayourfacility’sap-propriatereview.OnlyafterthisprocessiscompletedshouldaConfigurationbemadeavailabletopumpsforpatientuse.Adefinedprocessforassuringthatthenewupdateisinstalledonallpumpsinatimelyman-nershouldbedeveloped.


111

Battery and AC power operationTheinfusionpumpistypicallyoperatedbyAC(mains)power.Thepumpcontainsarechargeablebatterythatiscon-tinuallycharged–aslongasthepumpisconnectedtoACpower(seepage125forbatterylifespecification).IftheACisdisconnected−whilethepumpisturnedon−thepumpautomaticallybeginsdrawingpowerfromtheinternalbattery.

Attaching the power cord:1. Threadthepowercordconnectorthrough

thecordretainerandconnecttheACpowercordtotheconnectorportonthepump.

2. Insertthescrewsintothecordretainerandtightenthemtoattachthecordretainertothepump(topreventaccidentallyunpluggingthepump).

WARNING: Shock Hazard.TheonlymeansofremovingACpoweristodisconnecttheACpowercord.WhiletheACpowercordisattachedtothepumpandpluggedintoanACoutlet,livemainsvoltageispresentinsidethepump.


112

On screen display of internal battery power level gaugeWhenever the pump is turned on, the internal battery charge level briefly appears on the “battery shaped” gauge in the bottom left corner of the display.




When running an infusion on internal battery, this “battery shaped” gauge also appears briefly in the up-per right corner of the display at the start of delivery.

PVD 0.18 mL

RATE 5 mL/hR

LOCK

N

CHG RATE CLEAR TVD

100%B-D 60mL

Briefly display this “battery shaped” gauge at any time while the pump is infusing on battery by pressing â.

Battery guidelines Power & Battery Limits

When to charge the battery

When the “Battery Low” mes-sage displays, plug the pump into a power outlet for recharging. The battery indicator remains on continuously when charging. If the pump IS plugged into an out-let and fails to charge the battery, or the pump has been stored for longer than two months with-out charging, contact Service & Repair for information on how to test and/or service the battery.

When you can run on battery

The internal battery is intended to allow infusions of medications and fluids when an external pow-er outlet is not conveniently avail-able or when the patient is being moved.

When you cannot run on battery

When the battery becomes fully depleted, all infusion stops, and a “Battery Depleted” alarm begins sounding. For a fully de-pleted battery, plug in the AC power cord, turn the pump off to clear the alarm, and then turn the pump back on. Leave the pump plugged in for at least 8 hours to completely recharge the battery.

• See “General SyStem alarmS and alertS” table to identify battery message status.


113

Poleclamp assembly & use Thissectioncontainstheinstructionsforassemblingandusingthepoleclampoptionsavailableforthepump.

CAUTION:Thispumpisdesignedtobeusedinahorizontalposition.Ifthepumpisoperatedinaverti-calposition,thereisanincreasedpotentialforfluidleakingintothepump.Ifyoususpectfluidhasleakedintoapump,removeitfromserviceuntilatrainedbiomedicaltechniciancantestit.

Rotating/detachable poleclamp (standard)WiththeRotatingPoleclamp(catalognumber3000RPC),youcanalignthepoleclampformount-ingonanyverticalorhorizontalpole,bedrail,orsimilarsolidstructuresmallenoughtofitwithintheclamp’sjaws.Thelightweightofthepumpmakesthisconvenient.

1. Opentheclampjawswideenoughtoeasilysliparoundthepole.

2. Tightentheclampuntil it is securely fastenedsothepumpcannotbemoved.

Therotating/detachablepoleclampispackagedintwopiecesthatmustbeclippedtogetherbeforeitcanbeused:

• The“L”Bracketandclampanchorwithreleaselever-ispre-attachedtothepumpbasewith2“flathead”screws.

• TheRotatingpoleclamp-whichmustbeslidontotheclampanchoratthebackofthepump.

CAUTION:Alwaysverifythestabilityoftheobjecttowhichthepumpismounted(forinstance,anIVpole)usingthepoleclamp.Failuretoverifythestabil-itycouldcausetheobjecttotip,withthepossibilityofcausingdamagetothepumpandotherequipmentIfthepoleclampisnotadequatelytightened,itcouldcausethepumptofall.


114

Assembling the rotating/detachable poleclamp

1. Unpackthepumpandpoleclampassemblyfromtheshippingcontainer.

2. Slidetherotatingpoleclampontothepoleclampanchorattherearofthepumpuntiltheretainerlockbuttonaudiblyclicksintoplace.

3. Pulltheroundlockbuttonatthetopoftheclampassemblyupandrotatetheclamptofiteitheraverticalorhorizontalpole.

4. Toremovethepumpfromthepoleclamp,pullthereleaselevertowardthepumpandslidethepumpoffthepoleclamp.


115

Assembling the stationary poleclampAPhillipsheadscrewdriverisrequiredtoassemblethepoleclamp.

1. Unpackthepoleclampassemblyfromtheshippingcontainer.

2. The“L”bracketattachesthepoleclamptothepump.Whenyoureceivethepoleclampassemblyitisconfiguredforusewithaverticalpole.Ifyouwishtochangethisassemblyforusewithahorizontalpole(e.g.bedrail),reconfigurethe“L”bracketusingthefollowingsteps:• Removethe4“pan head”screwsand

theirlockwashersfromtherearofthepoleclamp.

• Alignthe“L”bracketforhorizontalmounting(seepreviouspage).Installthe4washersandpanheadscrewstomountthe“L”brackettotheclamp.Tightenthemtoatleast10in-lb(1.1Nm)torque.

3. Usethesmall“flathead”screwsand“star”lockwasherstoattachthepoleclamptothebottomofthepump.Tightenthemtoatleast10in-lb(1.1Nm)torque.


116

EMC information for the Medfusion® Model 4000 pump

ElectromagneticCompliance(EMC)precautionsarenecessarywhendealingwiththeMedfusion®Model4000pumps.AccessiblepinsofconnectorsidentifiedwiththeESDwarningsymbolnearthemshouldnotbetouchedwiththefingersorhand-heldtool,unlessproperprecautionarymeasuresarefollowed.Thesemeasuresinclude:1) Dischargingone’sbodytoearthortoalargemetal

object.2) BondingoneselfbymeansofanESDwriststrapto

earth.Itisrecommendedthatallstaff,includingclinicalandbiomedicalstaff,receivetraininginthemeaningoftheESDwarningsymbol,andontheaboveprecautionarymeasures.Thistrainingshouldalsoincludeanintroductiontothephysicsofelectrostaticdischarge,thevolt-agelevelsthatcanoccurinnormalpractice,andthedamagethatcanbedonetoelectroniccomponentsiftheyaretouchedbyanoperatorwhoiselectrostati-callycharged.Further,anexplanationshouldbegivenofthemethodstopreventbuild-upofelectrostaticcharge,andhowandwhytodischargeone’sbodytoearth,ortobondoneselfbymeansofawriststraptoearthpriortomakingaconnection.

Use of cables

WARNINGS: •UseofcablesotherthanaslistedbelowmayresultinincreasedEMCemissionsordecreasedimmunityofthepump.•UseofthelistedcableswithequipmentotherthanthosespecifiedmayresultinincreasedEMCemis-sionsordecreasedimmunityoftheequipmentorsystem.ItisrecommendedthatwhenconnectingthepumptoanetworkusinganEthernetcable,thenet-workequipmentshouldconformtoEN/IEC60950.•Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.

ThispumphasbeentestedforEMCwiththefollow-ingcables:

• SmithsMedical21-2145-01ACpowercord• Ethernetunshieldedlessthan3meter

Stacked equipment

WARNING:Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.

MedicalElectricalEquipmentneedsspecialprecau-tionsregardingEMCandneedstobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedinthismanual.PortableandmobileRFcommunicationequipmentcanaffectMedicalElectricalEquipment.


117

Technical specifications & other informationPump development standardsMedical Electrical Equipment SafetyReference (Year) TitleIEC60601-1(1988) MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety,Amendment

1(1991),Amendment2(1995)IEC60601-1-4(2000) Medicalelectricalequipment--Part1-4:Generalrequirementsforsafety-Collateral

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standard:usabilityIEC60601-2-24(1998) MedicalElectricalEquipment,Part2:Particularrequirementsforsafetyofinfusion

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standard:Programmableelectricalmedicalsystems.Amendment1(1999)EN60601-1-6(2007) Medicalelectricalequipment–Part1-6:Generalrequirementsforsafety–collateral

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MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety–November1990(CanadianDeviationstoIEC60601-1)UpdateNo.2(November2003)

AS/NZS3200.1.0(1998) Australian/NewZealandStandard,Medicalelectricalequipment-Part1.0:Generalrequirementsforsafety-ParentStandard(AustralianDeviationstoIEC60601-1)

AS/NZS3200.2.24(1999)

MedicalElectricalEquipment:Part2-24:Particularrequirementsforsafety-Infusionpumpsandcontrollers

Electromagnetic CompatibilityReference (Year) Title47CFRPart15.247,ClassB

FCCRulesandregulations47CFRpart15.247,ClassB

RSS-210,Issue7,(June2007)

Low-powerLicence-exemptRadiocommunicationDevices(AllFrequencyBands):CategoryIEquipment-Canada

EN60601-1-2(2007) Medicalelectricalequipment--Part1-2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-Requirementsandtests

EN61000-4-2(2009) ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques.Section2:ElectrostaticDischargeimmunitytest.BasicEMCPublication


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Reference (Year) TitleEN61000-4-3(2006) ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques.

Section3:Radiated,radiofrequency,electromagneticfieldsimmunitytest.BasicEMCPublication

EN61000-4-4(2004) ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques.Section4:Electricalfasttransients/burstsimmunitytest.BasicEMCPublication

EN61000-4-5(2006) ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques.Section5:Surgeimmunitytest.BasicEMCPublication

EN61000-4-6(2007) ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques.Section6:Immunitytoconducteddisturbances,inducedbyradiofrequencyfields.BasicEMCPublication

EN61000-4-8(1993) ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques,Section8:Powerfrequencymagneticfieldimmunitytest.Amendement(2001).

EN61000-4-11(2004) Electromagneticcompatibility(EMC)-Part4:Testingandmeasuringtechniques-Section11:Voltagedips,shortinterruptionsandvoltagevariationsimmunitytests

EN45502-1(1997) Activeimplantablemedicaldevices.Part1.Generalrequirementsforsafety,mark-ingandinformationtobeprovidedbythemanufacturer.Section27.1only.

EN45502-2-1(2003) Activeimplantablemedicaldevices--Part2-1:Particularrequirementsforactiveimplantablemedicaldevicesintendedtotreatbradyarrhythmia(cardiacpacemak-ers).Section27.8only.

EN55011(2007) Industrial,scientificandmedical(ISM)radiofrequencyequipment-Radiodistur-bancecharacteristics-Limitsandmethodsofmeasurement.

AS/NZS3200.1.2(2005) Australian/NewZealandStandard,Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-RequirementsandtestsParentStandard

CISPR11(2003) Industrial,scientificandmedical(ISM)radiofrequencyequipmentelectromagneticdisturbancecharacteristics-limitsandmethodsofmeasurement.Amendment1(2004),Amendment2(2006).

ASTMF2052-06 StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceonMedicalDevicesintheMagneticResonanceEnvironment

IEEE802.11(2007) IEEEStandardforInformationtechnology-Telecommunicationsandinforma-tionexchangebetweensystems-Localandmetropolitanareanetworks-Specificrequirements-Part11:WirelessLANMediumAccessControl(MAC)andPhysicalLayer(PHY)Specifications

ETSIEN300328(2006) V1.7.1-ElectromagneticcompatibilityandRadiospectrumMatters(ERM);WidebandTransmissionsystems;Datatransmissionequipmentoperatinginthe2,4GHzISMbandandusingspreadspectrummodulationtechniques;Part2:HarmonizedENcoveringessentialrequirementsunderarticle3.2oftheR&TTEDirective

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V1.8.1-ElectromagneticcompatibilityandRadiospectrumMatters(ERM);ElectroMagneticCompatibility(EMC)standardforradioequipmentandservices;Part1:Commontechnicalrequirements

ETSIEN301489-17(2002)

V1.2.1-ElectroMagneticCompatibilityandRadioSpectrumMatters(ERM);ElectroMagneticCompatibility(EMC)StandardforRadioEquipmentandServices;Part17:SpecificConditionsfor2,4GHzWidebandTransmissionSystemsand5GHzHighPerformanceRLANEquipment


119

Miscellaneous StandardsReference (Year) TitleIEC60320-1(2007) Appliancecouplersforhouseholdandsimilargeneralpurposes-Part1:General

requirements(IEC60320-1:2001+Amendment1:2007)

IEC60529(2001) DegreesofProtectionProvidedbyEnclosures(IPCode)IEC60878(2003) GraphicalSymbolsforelectricalequipmentinmedicalpracticeEN980(2008) GraphicalSymbolsforUseintheLabelingofMedicalDevicesEN1041(2008) InformationSuppliedbytheManufacturerwithMedicalDevicesENISO10993-1(2003) BiologicalEvaluationofMedicalDevicesPart1:EvaluationandTestingASTMD999-08 MethodforVibrationTestingofShippingContainersASTMD4169-08 PerformanceTestingofShippingContainersandSystemsASTMD4332-01(2006) ConditioningContainers,Packages,orPackagingComponentsforTestingASTMD4728-06 StandardTestMethodforRandomVibrationTestingofShippingContainerASTMF2097-08 StandardGuideforDesignandEvaluationofPrimaryPackagingforMedical

ProductsASTM5264-98(2004) StandardPracticeforAbrasionResistanceofPrintedMaterialsbytheSutherland

RubTesterASTMF2503-08 StandardPracticeforMarkingMedicaldevicesandOtherItemsforSafetyinthe

MagneticResonanceEnvironmentISO3744(1994) Acoustics-DeterminationofSoundPowerLevelsISO14971(2007) MedicalDevices,ApplicationofRiskManagementtoMedicalDevicesUL746C(2004) PolymericMaterials-UseinElectricalEquipmentEvaluations


120

Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsTheMedfusion®SyringeInfusionPumpModel4000isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheMedfusion®SyringeInfusionPumpModel4000shouldassurethatitisusedinsuchanenvironment.

Emissions test Compliance Electromagnetic environment - guidanceRFEmissions

CISPR11

Group1 TheMedfusion®SyringeInfusionPumpModel4000maybeconfiguredtouseRFenergyasawirelesscommunicationmethodtoanetwork.Therefore,whenusingthewirelesscommunicationmethod,theusershouldevaluatetheMedfusion®Model4000pumpintheenvironmentofitsintend-edusetoensurethattheRFenergyoutputdoesnotinterferewiththeoperationofotherdevices.

RFemissionsCISPR11

ClassA TheMedfusion®SyringeInfusionPumpModel4000issuitableforuseinallestablishmentsotherthandomesticandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsup-pliesbuildingsusedfordomesticpurposes.

Harmonicemissions

IEC61000-3-2

NotApplicable

Voltagefluctuations/Flickeremissions

IEC61000-3-3

NotApplicable

Compliance using:1. ACpowercordlengthof2.4m(8feet).2. Rechargeablelithiumionbatterypack.3. Ethernetcableoflessthan3m(9.75feet).

Exceedingthislengthcouldresultinincreasedsusceptibilitytoexternalelectromagneticinterfer-ence.

WARNING:Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.


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Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityTheMedfusion®SyringeInfusionPumpModel4000isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheMedfusion®SyringeInfusionPumpModel4000shouldassurethatitisusedinsuchanenvironment.

Immunity test IEC 60601 Test level

Compliance level Electromagnetic environment-guidance

ElectrostaticDischarge(ESD)

IEC61000-4-2

±6kVcontact

±8kVair

±8kVcontact

±15kVair

Floorsshouldbewood,concreteorceramictile.Iffloorsarecoveredwithsyntheticmaterial,therelativehumidityshouldbeatleast30%.

ElectricalfastTransient/burst

IEC61000-4-4

±2kVforpowersupplylines

±1kVforinput/outputlines

±2kVforpowersupplylines

±1kVforinput/outputlines

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenviron-ment.

Surge

IEC61000-4-5

±1kVdifferentialmode

±2kVcommonmode

±1kVdifferentialmode

±2kVcommonmode

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenviron-ment.

Voltagedips,shortinter-ruptionsandvoltagevariationsonpowersup-plyinputlines

IEC61000-4-11

<5%Uт(>95%dipinUт)for0.5cycle

40%Uт(60%dipinUт)for5cycles


<5%Uт(>95%dipinUт)for5sec

<5%Uт(>95%dipinUт)for0.5cycle



<5%Uт(>95%dipinUт)for5sec

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvi-ronment.IftheuseroftheMedfusion®SyringeInfusionPumpModel4000requirescontinuedoperationduringpowermainsinterruptions,itisrecom-mendedthattheMedfusion®SyringeInfusionPumpModel4000bepoweredfromanuninterruptiblepowersupply.

Powerfrequency(50/60Hz)Magneticfield

IEC61000-4-8

3A/m 400A/mand3A/m

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhos-pitalenvironment.

Note:UtistheACmainsvoltagepriortoapplicationofthetestlevel.


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Guidance and manufacturer’s declaration – electromagnetic immunityTheMedfusion®SyringeInfusionPumpModel4000isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheMedfusion®SyringeInfusionPumpModel4000shouldassurethatitisusedinsuchanenvironment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

ConductedRF

IEC61000-4-6

RadiatedRF

IEC61000-4-3

3Vrms

150kHzto80MHzoutsideISMbandsa

10Vrms

150kHzto80MHzinISMbandsa

10V/m

80MHzto2.5GHz

10V

10V

10V/m

Portable and mobile RF communicationsequipment should be used no closer to anypartoftheMedfusion®SyringeInfusionPumpModel4000,includingcables,thantherecom-mended separation distance calculated fromtheequationapplicabletothefrequencyofthetransmitter.Recommended separation distanced = 0.35

d = 1.2

d = 1.2 80MHzto800MHz

d = 2.3 800MHzto2.5GHzwherePisthemaximumoutputpowerratingof the transmitter inwatts (W) according tothetransmittermanufactureranddistherec-ommendedseparationdistanceinmetres(m).b

FieldstrengthsfromfixedRFtransmitters,asdeterminedbyanelectromagneticsitesurvey,c should be less than the compliance level ineachfrequencyrange.d

Interferencemayoccurinthevicinityofequip-mentmarkedwiththefollowingsymbol:

îNOTE1 At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstruc-tures,objectsandpeople.aTheISM(industrial,scientificandmedical)bandsbetween150kHzand80MHzare6.765MHzto6.795MHz;13.553MHzto13.567MHz;26.957MHzto27.283MHz;and40.66to40.70MHz.bThecompliancelevelsintheISMfrequencybandsbetween150kHzand80MHzandinthefrequencyrange80MHzto2.5GHzareintendedtodecreasethelikelihoodthatmobile/portablecommunicationsequipmentcouldcauseinterferenceif it is inadvertentlybroughtintopatientareas.Forthisreason,anadditionalfactorof10/3isusedincalculatingtherecommendedseparationdistancefortransmittersinthesefrequencyranges.cFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelec-tromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheMedfusion®SyringeInfusionPumpModel4000isusedexceedstheapplicableRFcompliancelevelabove,theMedfusion®SyringeInfusionPumpModel4000shouldbeobservedtoverifynormaloperation.Ifab-normalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingtheMedfusion®SyringeInfusionPumpModel4000.dOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.


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Recommended separation distances between portable and mobile RF communications equipment and the Medfusion® Syringe Infusion Pump Model 4000

TheMedfusion®SyringeInfusionPumpModel4000isintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheSyringeInfusionPumpModel4000canhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunica-tionsequipment(transmitters)andtheMedfusion®Model4000pumpasrecommendedbelow,accordingtothemaxi-mumoutputpowerofthecommunicationsequipment.

RatedMaximumoutputpoweror

transmitterW

Separation distance according to frequency of transmitter (m)150kHzto80MHzoutsideISMbands

d = 0.35

150kHzto80MHzinISMbands

d = 1.2

80MHzto800MHz

d = 1.2

800MHzto2.5GHz

d = 2.3

0.01 .04 .12 .12 .230.1 .11 .38 .38 .731 .35 1.2 1.2 2.310 1.1 3.8 3.8 7.3100 3.5 12 12 23

Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmeters(m)canbedeterminedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.

NOTE1At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies.

NOTE2TheISM(industrial,scientificandmedical)bandsbetween150kHzand80MHzare6.765MHzto6.795MHz;13.553MHzto13.567MHz;26.957MHzto27.283MHz;and40.66MHzto40.70MHz.

NOTE3Anadditionalfactorof10/3isusedincalculatingtherecommendedseparationdistancefortransmittersintheISMfrequencybandsbetween150kHzand80MHzandinthefrequencyrange80MHzto2.5GHztodecreasethelikelihoodthatmobile/portablecommunicationsequipmentcouldcauseinterferenceifitisinadvertentlybroughtintopatientareas.

NOTE4Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.

IEEE 802.11 b,g Radio for Auxiliary CommunicationTheMedfusion®Model4000pumpintentionallyreceivesRFelectromagneticenergyfornon-criticalcommunication.TheRFbandofreceptionis2412MHzto2462MHz.Thebandwidthofthesignalis20Mhz.

Note:Thepumpmaybeinterferedwithbyotherequipment,evenifthatotherequipmentcomplieswithCISPREMISSIONrequirements.

TheMedfusion®Model4000pumpincludesalowpowerRFtransmitterfornon-criticalcommunica-tion.TheRFbandoftransmissionis2412MHzto2462MHz.Thebandwidthofthesignalis20MHz.ThemodulationisOFDMandCCK.ThemaximumoutputpowerattheRFconnectoris0.032watts.


124

Technical specificationsSpecificationsBelowarethetechnicalspecificationsoftheMedfusion®Model4000pump.Testingwasperformedusingthesyringeslistedinthetableonpage130andthefollowingMedfusion®AdministrationSets:1)Model536040forlowflowratesand2)ModelMX448HL60forhighflowrates.

Minimum increment of resolution

0.01mL/hr

Size (pump only) 10.5”wide×6.2”high×5.7”deep(27cm×16cm×14.5cm)Weight Approximately4.54lbs.(2.04kg)Classification TypeCF(protectionfromelectricshock)Moisture protection IPX3(sprayproof)Pump Alarms Syringeempty,syringenearempty,syringenotloadedproperly,incorrectsyringe

size,infusioncomplete,KVO,batterylow/damaged/notworking,incorrectcalculation,(value)outofrange,occlusion/fluidrestricted/ratereduced/pressureincreasing,pumpstopped,systemfault,systemadvisory(settime/date,maintenancerecommended,datacorrupted)Foracompletelistofalarms,seetheGeneralsystemalarmsandalertstablestartingonpage103.

Time to occlusion alarm (typical values)

VeryHigh(50psi)testingperformedusingBD®1mLsyringe;HighandVeryLowtestingperformedusingBD®20mLsyringeFlow Rate Occlusion Setting Max time to

occlusion (steady state) hr:min:sec

Max time to occlusion (start up)

hr:min:sec1mL/hr VeryHigh 00:00:38 00:07:15(minimum) High 00:26:58 00:22:25

VeryLow 00:07:16 00:06:395mL/hr VeryHigh 00:00:13 00:00:36(intermediate) High 00:05:35 00:04:33

VeryLow 00:01:55 00:03:40Bolus volume at occlusion release (typical values)

Variable,dependentoninfusionvariablesandsyringeinuse.Typicalvaluesobtainedwhentestingapump,usingaBD®20mLsyringeatIntermediate(5mL/hr)rate:Bolus after occlusion at minimum selectable Occlusion alarm setting (Very Low) 0.0454mLBolus after occlusion at maximum selectable Occlusion alarm setting (High) 0.0815mL

WARNING:LargersizesyringesatocclusionsettingHIGHmayproduceapostocclusionboluslargerthan0.3mLduetoexcessivesyringeplungertipcompliance.

Power source Internal battery: Rechargeable(lithium-ion)AC power: 100-240VAC,50/60Hz,42VA;SafetyClassII–TypeCFwith

FunctionalEarthconductor


125

Battery Life 400chargecyclecountsminimumBattery longevity 10hourstypicalat5.0mL/hrwith60mLsyringe−(fromfullychargedbattery)Operating conditions Temperature: 5°to40°C(40°to104°F)

Relative Humidity: 20to95%non-condensingAmbient Pressure: 70kPato106kPa(10.2psiato15.4psia)

Infusion Back Pressure -100mmHgto300mmHgStorage/transportation conditions

Temperature: –20°to50°C(–4°to122°F)

Relative Humidity: 20%to95%non-condensingAmbient Pressure: 70kPato106kPa(10.2psiato15.4psia)

Delivery Accuracy Nominal±2%(±syringeaccuracy)(forinfusionbackpressuresof-100mmHgto+300mmHg).Atlowinfusionrates,thesystemaccuracymaynotbeachievedforshortperiods.Duringthetotalinfusiontime,theaccuracyaveragesout(seeaccuracycurves,page138).Overallflowrateaccuracyisequaltopumpaccuracycombinedwithsyringetolerances.ForsyringesspecifiedtomeettheISO7886-2standard,syringeaccuracymaybeexpectedtomeetthe±2%requirement.

WARNING:Ensurethatthe±2%accuracyspecificationistakenintoaccountwhenprogrammingthepumpand/orfillingasyringe.Ifaccuracyisofprimeconcern,useonlysyringesthatmeetthe±2%requirementoftheISO7886-2Standard.Failuretodosomayresult inmedication in thesyringebecomingdepletedsooner thanexpected.Ifthepumpisbeingusedtodelivercriticalorlifesustainingmedication,theinterruptioninthedeliveryofmedicationcouldresultinpatientinjuryordeath.

Bolus Accuracy ThisdatatakenwithBD®20mLsyringeMinimum Bolus* Minimum

Recommended BolusMaximum Bolus

Average(mL) 0.0298 0.98767 19.8302%AverageError -11.09 -1.23 -0.85MaximumPos.Error%

14.12 0.32 -0.38

MaximumNeg.Error%

-44.71 -3.52** -1.369

MinimumDeviation(mL)

-0.0040 0.0032 -0.07520

MaximumDeviation(mL)

-0.0152 -0.0352 -0.27220

*IMPORTANT:“MinimumBolus”referstotheminimumbolusthatcanbesetonthepump,andwhichmaybebelowtherecommendedminimumrateforthesyringe.**NOTE:2%ofthemeasurederrormaybeduetosyringecharacteristicsperISO7886-2


126

Occlusion Alarm For1mLSyringes,theocclusionlimitisfixedatVery High.Very High(1mLsyringeonly,notselectable):50psi(2585mmHg)(345kPa)ForSyringeswithavolumegreaterthan1mL,theusercansettheocclusionlimitfromVeryLowtoHigh.High: 16psi(827mmHg)(110kPa)Normal: 12psi(621mmHg)(83kPa)Low: 8psi(413mmHg)(55kPa)Very Low: 4psi(206mmHg)(28kPa)

Maximum volume infused under single fault conditions

1/100thofthesyringesizebyvolume

Maximum delivery rate during bolus

Theconfiguredmaximumrateatwhichabolusorloadingdosecanbedeliveredis:Syringesize×5mL/hr,Syringesize×10mL/hrorSyringesizeMaxmL/hr(seepage135forfurtherexplanation)

Maximum delivery rate during Prime

Theprimingdeliveryrateis300mL/hrorthedefaultmaximumbolusrateforthesyringesizebeingused(Syringesize×5mL/hr,Syringesize×10mL/hrorSyringesizeMaxmL/hr),whicheverislower(seepage135,MaximumBolusRate,forfurtherexplanation)

Infusion rate range: 0.01mL/hrto1130mL/hrinincrementsof0.01/0.1mL/hr(dependingonsyringesize/rate).Refertosyringetablesonpage131forMinimumRecommendedRate.

Bolus volume range: Volumeislimitedtothemaximumfillvolumeofthecurrentsyringesize,andminimumvolumeis1/600ththesyringesize

Note:TheMinimumRecommendedBolusVolumeis10%ofsyringeor1mL,whicheverissmaller.Bolusvolumesdeliveredthatarelessthentherecommendedminimumbolusvolumeforthesyringeusedmayresultindeliveryinaccuracies.

Delivery modes (user customized)

Continuous Delivery Modes:Dose/min,hr,dayDose/kg/min,hour,dayDose/m2/min,hr,daymL/hrmL/kg/min,hr

Intermittent Delivery Modes:Dose/kg/timeDose/m2/timemL/kg/timeVolume/timeDose/timeIntermittentvolume/time

Delivery Options (user customized)

VolumeLimitBolusDoseLoadingDoseKVOStandbyOverrideOcclusionLimitPeriodicCallback

ToggleFlowSentry™DelayedStartOverrideAlarmLoudnessTogglePVD/PDDDisable/EnableVolEmptyToneDisable/EnableNearEmptyTone


127

User-defined libraries StandardlibrariesareorganizedonaperProfilebasis.EachProfileallowsuptoeightlibraryCategorieswithupto36DrugProgramseach,foratotalof288en-triesperprofileOne“QuickLibrary”perProfileforrapidsetup

Accessories (may not be available in all areas; contact customer service for availability)

RotatingPoleclamp(catalognumber3000RPC)PharmGuard®Toolbox2,Version2.1Software(catalognumber22-4075-0201-51)Medfusion™StandardConfiguration(catalognumber67-2460-0001-51)Medfusion™StandardSyringes(catalognumber67-2459-0100-51)PharmGuard™SupportedSyringes(PSS)Series2(various,contactSmithsMedicalfordetails)Forreplacementparts,includingpowercordsandreplacementbatterypacks,seetheMedfusion® Model 4000 Series Technical Service Manual(catalognumber67-2452-51)


128

DrivePhaseA/BPOST,theabilityforthewatchdogtostopthemotor(MotorDriveoffPOST).Periodicallyduringpumpoperationsthesoftwarechecksmotoroperationinbackground.Motorback-groundchecksincludethestoppingofthemotorwhenaninfusionstopsandthemotorsupplyvoltagetest.IfamotorPOSTorbackgroundcheckfailsthepumpwilldisplayasystemfaultscreen,turnonacontinu-oustwo-toneaudiblealarm,flashthebacklightandstopalldrugdelivery.IftheMotorshaftfailstocompletethefirstshaftrotation(MotorNotRunning)orasubsequentshaftrotation(MotorRateError)withtheexpectedtimingthepumpwilldisplayahighpriorityalarm,turnonacontinuoustwo-toneaudiblealarm,flashthebacklightandstopalldrugdelivery.WhenthepumpispoweredonwithadepletedbatteryandnoACpower,thisalarmmaysoundduetothelowbatterystate.Rechargethebattery,turnthepumpon,turnthepumpoff,thenturnthepumpontoclearthecondition.

Keyboard Encoder Check - Control key POST or

BGND Everytimethesoftwarereceivesdatafromthekey-boardencoder,itischecked.Ifthedataisnotavalidkeypress,thesoftwarewilldisregardthekeypress.

Data Handling Software Safety FeaturesData Stored in EEPROM - Critical data POST or EEPROM timeout or Primary/Secondary critical data corruptedBeforeuse,dataassociatedwithdeliveryandstoredinEEPROMistestedbycalculatingaCRConthedataandthencomparingitwiththeCRCstoredwiththedata.IftheEEPROMtimeoutorEEPROMPrimaryandSecondarystoredandcalculatedCRCsdonotmatch,thesoftwarewilldisplayasystemfaultscreen,turnonacontinuoustwo-toneaudiblealarm,andstopalldrugdelivery.

Data Used in Calculations - Critical data failureCalculationsondatausedinsomewaytocontrolthedeliveryofdrugareperformedredundantly.

Safety FeaturesSafety Features and Fault DetectionHardware Safety FeaturesAwatchdogcircuit,madeupofaseparatemicro-controllerwithadedicatedtimer,alarmspeaker,andpowersupply,monitorsthemainmicroprocessorandassociatedelectronics.Thepurposeofthiscircuitistodetectfailuresofthesystemincludingpower,electronicsandsoftware,andgenerateanalarmifoneisdetected.Ifafailureisdetected,awatchdogor"SYSTEMFAILURE"alarmwillbegeneratedthroughthededicatedspeaker,theredalarmindicatorwillbeturnedon,andthepumpingmechanismwillbedisabled.Somewatchdogfailures(forexample,onethatmayoccurrarelywhenpoweringdownfollow-ingaConfigurationupdate)maybeclearedbycyclingpoweronthepump.

Software Safety FeaturesHardware-related Software Safety FeaturesProgram Memory - Check FLASH memory POST or BGNDAtpowerupandatregularintervalsthereafter,theprogrammemoryistestedbycalculatingaCyclicRedundancyCode(CRC)ontheprogramandthencomparingitwiththeCRCstoredwiththeprogram.IfthestoredandcalculatedCRCsdonotmatch,thesoftwarewilldisplayasystemfaultscreen,turnonacontinuousaudiblealarm,andstopalldrugdelivery.

RAM Memory Check - RAM BGND Duringoperation,therandomaccessmemoryischecked.AseriesofbitpatternsiswrittentoandreadfromtheRAM.Ifthereaddataisdifferentfromthewrittendata,thesoftwarewilldisplayasystemfaultscreen,turnonacontinuousalarm,andstopalldrugdelivery.

Motor Circuit Check - pump motor phase A or B POST and Motor rate error during operationAtpowerupthepumpperformspoweronselftest(POST)checksofthemotor.MotorPOSTchecksin-cludetheabilitytodrivecurrenttothemotor(Motor


129

Thetwocalculatedvaluesarethencompared.Ifthetwovaluesdonotmatch,thesoftwarewilldisplayasystemfaultscreen,turnonacontinuoustwo-toneaudiblealarm,andstopalldrugdelivery.

Timer Data Registers - Time base BGND, time of day clock POST, time of day clock timeout ThedataintheRealTimeClockischeckedatregularintervals.Ifthedataisnotreasonable,thesoftwarewillturnonacontinuoustwo-toneaudiblealarmandstopalldrugdelivery.


130

Additional Technical InformationMedfusion™ Standard SyringesBelowisatableofthestandardmodelsyringessuppliedwithPharmGuard®Toolbox2(andincludedintheMedfusion™StandardConfiguration)whichcanbeusedwiththeMedfusion®Model4000pump.(InformationregardingsyringeflowrateandminimumvolumeforthesesyringescanbefoundonthenextpageandintheproductliteraturesuppliedwiththePharmGuard®Toolbox2.)

Model (Manufacturer) Syringe Model/SizesB-D® (Becton-Dickinson)

1,3,5,10,20,30and60mL(LuerLok™)1mL(Tuberculin)

Monoject® (Clovidien) 3,6,12,20,35and60mL(Luerlock)1mL(Tuberculin)

Terumo® (Terumo® Medical)

3,5,10,20,30and60mL(LuerLock)1mL(Tuberculin)

BB Omnifix™ (B. Braun) 5,10,20and50mL(LuerLock)

BB Perfusor® (B. Braun) 20and50mL(LuerLock)

Thecriticalvolume(maximum)whichcouldbeinfusedintheeventofasinglepointfailureis1/100thofthesyringesizebyvolume.

PharmGuard™ Supported Syringes (PSS) Series 2Inordertooffercustomersawiderangeofavailablesy-ringemanufacturersandsizes,SmithsMedicalhasavail-ablePharmGuard™SupportedSyringes(PSS)Series2inadditiontotheMedfusion™StandardSyringes.Refertowww.smiths-medical.comorcallCustomerServiceformoreinformationaboutavailablePharmGuard™SupportedSyringes(PSS)Series2.ThePharmGuard™SupportedSyringes(PSS)Series2canonlybeimportedintothePharmGuard®Toolbox2.TheseadditionalsyringemodelscanbesenttoapumpasavailablesyringesforthedownloadableConfigurations.(InformationregardingsyringeflowrateandminimumvolumeforthesesyringescanbefoundintheproductliteraturesuppliedwiththePSSSeries2.)


131

Flow rate & minimum volume by manufacturer & size - Standard syringesForflowrateandminimumvolumeinformationregard-ingsyringesavailableinthePharmGuard™SupportedSyringes(PSS)Series2,seetheproductliteraturepro-videdwiththatproduct.Pleaseseethetablesonpage131forinformationregardingthelowestrecommendedratesforeachsyringesizeusedonthepump.Thetablebelowisprovidedforconvenience.Shouldchangestothelistedsyringesoccur,thevaluesshownheremaybesuperceded(seetheInstructions for UseprovidedwiththeMedfusion™StandardSyringes.)

Model (Manufacturer)

Size Min. Rate Max. Rate Minimum volume to infuse

Minimum recommended rate

mL mL/hr mL/hr mL mL/hrFlowSentry™

disabledFlowSentry™

enabledB-D (Becton-Dickinson)

Tuberculin 1 0.01 29 0.0016 0.033 N/A*Luer Lok™ 1 0.01 29 0.0016 0.033 N/A*

3 0.01 98 0.005 0.1 0.035 0.03 191 0.0083 0.17 0.05

10 0.05 277 0.0166 0.33 0.120 0.1 483 0.0333 0.67 0.230 0.1 622 0.05 1 0.360 0.1 944 0.1 2 0.6

Monoject® (Covidien)Tuberculin 1 0.01 29 0.0016 0.033 N/A*Luer Lock 3 0.01 105 0.005 0.1 0.03

6 0.03 213 0.01 0.2 0.0612 0.05 325 0.02 0.4 0.1220 0.1 536 0.0333 0.67 0.235 0.1 735 0.0583 1.2 0.3560 0.1 944 0.1 2 0.6

Terumo® (Terumo® Medical)Tuberculin 1 0.01 29 0.0016 0.033 N/A*Luer Lock 3 0.01 106 0.005 0.1 N/A*

5 0.03 225 0.0083 0.17 N/A*

10 0.05 333 0.0166 0.33 N/A*20 0.1 541 0.0333 0.67 N/A*30 0.1 712 0.05 1 N/A*60 0.11 1130 0.1 2 N/A*


132

Model (Manufacturer)

Size Min. Rate Max. Rate Minimum volume to infuse

Minimum recommended rate

mL mL/hr mL/hr mL mL/hrBB Perfusor® (B. Braun)

Luer Lock 20 0.1 481 0.0333 0.67 0.250 0.1 1042 0.0833 1.7 0.5

BB Omnifix™ (B. Braun)Luer Lock 5 0.03 207 0.0083 0.17 0.05

10 0.05 338 0.0166 0.33 0.120 0.1 537 0.0333 0.67 0.250 0.1 1042 0.0833 1.7 0.5

*FlowSentry™isnotavailablewith1mLandTerumo®syringes.Syringe Size Minimum Recommended

Bolus Volume1mL 0.1mL

3mL 0.3mL

5mL 0.5mL

6mL 0.6mL

10mL 1mL

12mL 1mL

20mL 1mL

30mL 1mL

35mL 1mL

50mL 1mL

60mL 1mL

WARNING:Usethesmallestsyringesizenecessarytodeliverthefluidormedication.Usingalargesyringeatverylowrates(belowMinimumRecommendedRateforthesyringe)maycauseimproperpumpoperation,delayedocclusionsensing,largerpostocclusionbolusathigherocclusionlimitsettings,deliveryinaccuracies,orotherpotentialhazards.Bolus Volume:Deliveringabolusvolumelessthentherecommendedbolusvolumeforthesyringeusedmayresultindeliveryinaccuracies.Useaninfusionsetwiththesmallestdiametertubingavail-ablethatdoesnotresultinexcessivebackpressureatthedesiredflowrate.Considerpriming,loading,bolus,andflushrateswhenselectinganinfusionset.


133

Concentration and dosing units Drug Delivery Units

Concentration Units Delivery Units /Time /Min /Hr /DayMillimoles Millimoles • • • •Milliequivalents Milliequivalents • • • •Units Units • • • •

Milliunits • • • •Grams Grams • • • •

Milligrams • • • •Milligrams Milligrams • • • •

Micrograms • • • •Micrograms Micrograms • • • •

Nanograms • • • •

PharmGuard™ software limitsPharmGuard™ software limits

Delivery Mode Parameter Limit Type Limit RangemL/hr mL/hrrate HardandSoft UserDefinedVolume / Time Volume HardandSoft UserDefined

Time HardandSoft UserDefinedIntermittent Volume / Time

Volume HardandSoft UserDefinedTime HardandSoft UserDefinedTimeBetweenStarts HardandSoft UserDefined

Dose / Time Concentration HardandSoft UserDefinedDose HardandSoft UserDefinedTime HardandSoft UserDefines

Dose / Kg/ Time Concentration HardandSoft UserDefinedBodyWeight Configurable UserDefinedDose HardandSoft UserDefinedTime HardandSoft UserDefined

mL / Kg/ Time BodyWeight HardMAX,SoftHighLimit(LowandMINcannotbeset)

UserDefined

Volume/kg HardandSoft UserDefinedTime HardandSoft UserDefined

Dose / m2 / Time Concentration HardandSoft UserDefinedm2 Configurable UserDefinedDose HardandSoft UserDefinedTime HardandSoft UserDefined


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PharmGuard™ software limitsDelivery Mode Parameter Limit Type Limit RangeDose / Hr Dose / Min Dose / Day

Concentration HardandSoft UserDefinedDose HardandSoft UserDefined

Dose / Kg / Hr Dose / Kg / Min Dose / Kg / Day

Concentration HardandSoft UserDefinedBodyweight Configurable UserDefinedDoserate HardandSoft UserDefined

mL / Kg / Hr mL / Kg / Min

BodyWeight HardandSoft UserDefinedVolume/kg HardandSoft UserDefined

Dose / m2 / Hr Dose / m2 / Min Dose / m2 / Day

Concentration HardandSoft UserDefinedm2 Configurable UserDefinedDoserate HardandSoft UserDefined

Options Parameter Limit Type Limit rangeLoading dose Dose HardandSoft UserDefined

Time HardandSoft UserDefinedBolus dose Dose HardandSoft UserDefined

Time HardandSoft UserDefinedKVO Rate Hard UserDefined

Volume HardMAXMax bolus rate Rate Hard UserDefined

Configuration optionsApump’sAlarm Setup,Auto Prompts,Limits,Occlusion DetectionsettingsandmanymiscellaneouspropertiescanbecustomizedwithinthePharmGuard®Toolbox2software.Thesepropertiesdefinethelimitsimposedbyapumpandthegeneraloperationalbehaviorofapump.Thefollowingisalistofuserconfigurablesettingsthatareavailable.Eachofthesesettingsiscustomizableforeachprofilethatisdefined.

General OptionsGeneralOptionsareoptionalsettingsthataffectallinfusionsinitiatedinthedefinedprofile.1mL Syringe Support Definesif1mLsyringesupportisenabled.Youcanselectfromtwovalues:

EnabledorDisabled.Alarm Loudness Definestheloudnesslevelofapump’salarm.Youcanselectfromfivelevels:

Level 1,Level 2,Level 3,Level 4,orLevel 5(Level1isthesoftest,Level5theloudest).Thealarmcannotbedisabledorcompletelysilenced.

Alarm Silence Time DefinesthenumberofminutesuntiltheUserCallbackalarmwillsound.AlarmSilenceTimeisanumericvalueintherange1to2minutes.

Alarm Style Definesthetonestyleapumpwillusewhensoundinganalarm.Youcanselect


135

fromthreestyles:Medfusion® Defined,International StandardandMedfusion® Multi-tone.

Auto Lock Time Definesthenumberofsecondsthepumpwillwaitbeforeautomaticallylockingthepump’sinterface.AutoLockTimeisanumericvalueintherange0to999seconds.SettingthisvaluetozerowilldisabletheAuto Lockfeature.

Bolus Change in mL DefinesifapumpusercanchangeaBolus DoseorLoading DoseinmL.Youcanselectfromtwovalues:EnabledorDisabled.

Bolus Time Feature DefinesifapumpuserwillhavetoenteratimewhensettingaBolus Dose using a manual delivery mode.Due to a conflict between library and profile options, bolus time is always enabled inside of library programs.Youcanselectfromtwovalues:EnabledorDisabled.

Bolus Total Dose DefinesifapumpuserwillbeallowedtoenteraBolusDoseorLoadingDoseasaTotalDoseratherthanthestandarddose/kginweightbasedmodes.Selectfromtwovalues—EnabledandDisabled.

Date Separator Defineswhetherdatesareseparatedbyaslash(yyyy/mm/dd)oradash(yyyy-mm-dd).

Decimal Separator Defineswhetherdecimalpointsinnumbersarerepresentedbyacommaoraperiod.

Enter User ID on Override DefinesifthepumpwillpromptauserfortheirUser IDwhenoverridingaDrugPrograminfusionproperty.Youcanselectfromtwovalues:EnabledorDisabled.

Flush Definesifthepumpwillpromptausertoprogramaflushinfusionfollowingcompletionofaninfusion.Youcanselectfromtwovalues:Enabledordisabled.

Flush Time Defineswhetherauserwillbeallowedtosetaninfusiontimeforaflushinfu-sion.Youcanselectfromtwovalues:Enabledordisabled.

Maximum Flush Volume Definesthemaximumvolumeallowedbythepumpduringaflushinfusion.Maximumflushvolumeisanumericvaluefromtheminimumvolumeforthesyringetothefillvolumeofthesyringe.

FlowSentry™ DefinesiftheFlowSentry™(RapidOcclusionDetection)featureisenabled.Youcanselectfromtwovalues:EnabledorDisabled.

FlowSentry™ Sensitivity DefinesthesensitivityoftheFlowSentry™algorithmduringnormalinfusion.Youcanselectfromfourvalues:Low - least sensitive,Normal,High,orVery High - most sensitive.

FlowSentry™ Startup Sensitivity DefinesthesensitivityoftheFlowSentry™algorithmduringinfusionstartup.Youcanselectfromfourvalues:Low - least sensitive,Normal,High,orVery High - most sensitive.

Key Click (key click loudness) Definestheclickloudnesslevelwhenpressingpumpkeys.Youcanselectfromfivelevels:Off,Level 2,Level 3,Level 4,orLevel 5(Level5istheloudest).

Maximum Body Surface Area DefinesthemaximumallowedvaluefortheBody Surface Areainfusionparam-eter.MaximumBodySurfaceAreaisanumericvalueintherange0.0001to4m2.

Maximum Bolus Rate Definesthemaximumbolusinfusionrateallowedbythepump.Youcanselectfromthreerates:Syringe Size x 5 mL/hr(example:5mLsyringe×5mL/hr=25


136

mL/hrmaximumbolusrate),Syringe Size x 10 mL/hr (example:5mLsyringe×10mL/hr=50mL/hrmaximumbolusrate),orSyringe Size Max mL/hr (seethetableonpage131).

Maximum Flow Rate Definesthemaximumflowrateallowedbythepump.MaximumFlowRateisanumericvalueintherange0.1to1130mL/hr.

Maximum Patient Weight DefinesthemaximumallowedvalueforthePatient Weightinfusionparameter.MaximumPatientWeightisanumericvalueintherange0.25to250kg.

Near Vol Empty Time Definesthenumberofminutesremainingbeforeasyringeisempty,atwhichtimeaSyringe Near Empty Alarmwilloccur.NearEmptyAlarmTimeisanu-mericvalueintherange0to240minutes.SettingthisvaluetozerowilldisabletheSyringe Near Empty Alarm.

Near Empty Alarm Priority DefinestheprioritylevelatwhichtogeneratetheSyringe Near Empty Alarm.Youcanselectfromtwolevels:LoworMedium.

Occlusion Limit Definesthepressureatwhichthepumpwillconsiderthelineoccluded.Youcanselectfromfourlimits:Very Low (Approx. 4 psi, 206.9 mmHg),Low (Approx. 8 psi, 413.7 mmHg),Normal (Approx. 12 psi, 620.6 mmHg),andHigh (Approx. 16 psi, 827.4 mmHg).For1mLsyringes,theocclusionlimitisfixedatVery High(Approx.50psi)andcannotbechanged.

Profile Passcode Definesthepasscodethatmustbeenteredtoaccessaprofilewhenprogram-minganinfusion.ProfilePasscodescanbeanynumericcodeintherangeof1000to9999.TodisableaProfilePasscode,simplydeletethecontentsofthisproperty.

Program Dose Display DefinesifthepumpwilldisplaythedeliveredProgram DoseorthedeliveredProgramVolume.Youcanselectfromtwovalues:VolumeorDose.

Unlock Passcode Definesthepasscodethatmustbeenteredatapumptounlockitsinterface.UnlockPasscodescanbeanynumericcodeintherange0to9999.TodisabletheUnlockPasscode,simplydeletethecontentsofthisproperty.

Program OptionsProgramOptionsareoptionalsettingsthataffectthecurrentinfusioninitiatedinthedefinedprofile.Whileindividualoptionscanbeenabledforaprofile,theycanalsobedisabledinindividualdrugprogramswithinthatprofile.Settingsindrugprogramstakepriorityoverthoseoftheprofile.Bolus Dose DefinesifapumpuserwillbeabletoenteraBolus Doseduringinfusionsetup.Delayed Start DefinesifapumpuserwillbeabletoenteraDelayed Starttimeduringinfu-

sionsetup.Therangeis0to6hours.KVO DefinesifapumpuserwillbeabletoenteraKeep-Vein-Open(KVO)rate.

Thisvaluecannotbesetorchangedwhileaninfusionisrunning.Loading Dose DefinesifapumpuserwillbeabletoenteraLoading Doseduringinfusion

setup.Override Alarm Loudness Definesifapumpuserwillbeabletochangetheloudnesslevelofapump’s

alarmduringaninfusion.


137

Override Occlusion Limit Definesifapumpuserwillbeabletooverridetheprofiledefaultsettingofthepressureatwhichthepumpwillconsiderthelineoccludedforthecurrentinfusion.

Periodic Callback Alarm DefinesifapumpuserwillbeabletoenteraPeriodic Callback Alarmtimedur-inginfusionsetup.Therangeis0to8hours.

Standby DefinesifapumpuserwillbeabletoenteraStandbytimeduringinfusionsetup.Therangeis0to24hours.

Toggle Vol Empty Tone DefinesifapumpuserwillbeabletodisabletheSyringe Vol Empty AlarmToneforthecurrentinfusion.(TheusercallbackalarmwillstillbeactivatedafterthedefinedAlarm Silence Time).

Toggle FlowSentry™ DefinesifapumpuserwillbeabletodisabletheFlowSentry™(RapidOcclusionDetection)featureforthecurrentinfusion.

Toggle Near Empty Tone DefinesifapumpuserwillbeabletodisabletheSyringe Near Empty Alarm Toneforthecurrentinfusion.

Toggle PVD/PDD Displayedonthepumpoptionsmenuas“ChangetoDose”or“ChangetoVolume.”Definesifapumpuserwillbeabletochangetheprofiledefaultset-tingtodisplaythedeliveredProgram DoseorthedeliveredProgram Volume.

Volume Limit DefinesifapumpuserwillbeabletoenteraVolume Limitduringinfusionsetup.Thisvaluecannotbesetorchangedwhileaninfusionisrunning.Therangeis0to500mL.

Auto Prompt OptionsAutoPromptOptionsareoptionalsettingsthattheuserwillbepromptedtoenterforallinfusionsinitiatedinthedefinedprofile.ThedefaultforallAutoPromptOptionsisDisabled.Bolus Dose DefinesifapumpuserwillbepromptedtoenteraBolus Doseduringinfusion

setup.Youcanselectfromtwovalues:EnabledorDisabled.Confirm Settings DefinesifapumpuserwillbepromptedtoConfirm Infusion Settingswhen

settingupaninfusion.Oncetheinfusionsettingsaremade,ifConfirmSettingsisenabledtheuserwillberequiredtore-confirmthesettings.Youcanselectfromtwovalues:EnabledorDisabled.

Enter User ID to Program DefinesifapumpuserwillbepromptedtoentertheirUser IDwhensettingupaninfusion.Youcanselectfromtwovalues:EnabledorDisabled.

Prompt to Prime DefinesifapumpuserwillbepromptedtoPrimeasalaststepinsettingupaninfusion.Youcanselectfromtwovalues:EnabledorDisabled.

Re-enter Weight Definesifapumpuserwillbepromptedtore-enterapatient’sweighttwicetoconfirmthesetting(adoublecheck).Youcanselectfromtwovalues:EnabledorDisabled.

Standby DefinesifapumpuserwillbepromptedtoenteraStandbytimeduringinfu-sionsetup.Youcanselectfromtwovalues:EnabledorDisabled.

Volume Limit DefinesifapumpuserwillbepromptedtoenteraVolume Limitduringinfu-sionsetup.Youcanselectfromtwovalues:EnabledorDisabled.


138

Device Setup FeaturesThefollowingitemsaresetonaperpumpbasisintheDeviceSetupmenu.Allofthesefeaturesareoptional,andwhiletheydonotdirectlyaffectinfusionprogram-ming,theycanaffectalarmsandreporting.Preventative maintenance date Definesthedatewhenthepump'spreventativemaintenancerequiredalarm

activates.Time Zone Definesthetimezonewherethepumpislocated.Daylight Saving DefinesifapumpwillautomaticallyswitchtoDaylightSavingTimeontheap-

propriatedate.Ifselected,youmustspecifywhenDaylightSavingbeginsandends,whattimetheclockschange,andbyhowmuch.

Flow Delivery GraphsInthisdevice,aswithallsyringeinfusionpumps,themotionofthepumpingmechanismandvariationsinindividualdisposables(boththesyringeandinfusionset)causeshort-termfluctuationsintherateaccuracy.Thecurvesonthefollowingpageshowtypicalperfor-manceofthepumpsystemintwoways:1. Aflowversustimegraphduringthestabilization

period(start-upcurves).2. Theaccuracyoffluiddeliveryofparticulartime

periodsor‘observationwindows’ismeasured(trumpetcurves).

Thestart-upcurvedisplaysflowratecontinuouslyfromthestartoftheinfusion.Thecurvevisuallyrepresentsflowrateuniformity.Trumpetcurvesarederivedfromthesecondhourofthisdata.TestswereperformedpertheIEC60601-2-24standard.Overlongobservationwindows,shorttermfluctua-tionshaveminimaleffectonaccuracyasrepresentedbytheflatpartofthecurve.Astheobservationwindowisreduced,shorttermfluctuationshaveanincreasingeffectasrepresentedbythe“mouth”ofthetrumpet.Beingawareofsystemaccuracyovervariousobservationwindowsmaybeofinterestwhencertaindrugsarebeingadministered.Shorttermfluctuationsinrateaccuracymayhaveclinicalimpactdependingonthehalf-lifeofthedrugbeinginfused,thereforeboththetrumpetcurveanddrughalf-lifeshouldbetakenintoaccount.

ThedatawascreatedusingaMedfusion®pumpandBecton-Dickinson(B-D®)WWD30mLsyringe.The1mL/hrdatawascreatedusingtheMedfusion®536040Extensionsetand18Gneedle.The5mL/hrdatawascreatedusingtheMedfusion®MX448HL60Extensionsetand18Gneedle.


139

Start-up curves over stabilization periodMinimumrate(1mL/hr) Intermediaterate(5mL/hr)

0

0.5

1

1.5

2

0 10 20 30 40 50 60 70 80 90 100 110 120

time [Min]

�ow

[ml/h

]

Flow rate immediately following startup

Flow rate immediately following startup

0

2.5

5

7.5

10

0 10 20 30 40 50 60 70 80 90 100 110 120

time [Min]

�ow

[ml/h

]

Trumpet curves over T2 periodMinimumrate(1mL/hr)

2 5 11 19 31

-10.0

-7.5

-5.0

-2.5

0.0

2.5

5.0

7.5

10.0

T (min)

-1.47%

Trumpet Curve

Epmax

Epmin

% E

rror

of F

low

Intermediaterate(5mL/hr)

2 5 11 19 31

-10.0

-7.5

-5.0

-2.5

0.0

2.5

5.0

7.5

10.0

T (min)

Trumpet Curve

Epmax

Epmin

% E

rror

of F

low

0.54%


140

Communications TheconnectivitystatesavailableforMedfusion®Model4000pumpsareEthernetandWireless.Thepumpdisplayshowsaniconindicatingwhichinter-faceisactive(seepage11).WhenevercommunicationwiththePharmGuard®Serverisoccurring,theblue“Communicating”light()willbeon.(SeetheNetworkSettingsManualforinformationinhowtosetuptheseinterfaces.)ThepumpcanbeusedwithaPCrunningPharmGuard®Toolbox2Softwaretoconfigurethepump.ThisprocessisdescribedinthePharmGuard®Toolbox2User’sManual,andtheNetworkSettingsmanual.

Magnetic Resonance Imaging (MRI) InformationTheMedfusion®Model4000pumpisMRConditionalaccordingtotheterminologyspecifiedintheAmericanSocietyforTestingandMaterials(ASTM)International,Designation:F2503-08,StandardPracticeforMarkingMedicalDevicesandOtherItemsforSafetyintheMagneticResonanceEnvironment.Non-clinicaltestingdemonstratedthattheMedfusion®Model4000pumpisMRConditional.ThepumpwillnotpresentahazardorrisktothepatientorMRuser,orsignificantlyaffecttheMRim-agequalityifthepumpisoperatedaccordingtothespecificguidelinesasfollows:

WARNING:ThepumpmustbepositionedinanMRenvironmentsuchthatitissecured to a non-moveable objectandthemagneticfringefielddoes not exceed 150 gauss.ExposingtheMedfusion®Model4000pumptomagneticfieldsthatexceed150gausspres-entsariskofbecomingaprojectilehazardandcanleadtopossiblepatientinjuryordeath.Irreversibledamagetothepumpcanalsooccur,renderingitinop-erable.

MRI Related TestingInnon-clinicaltesting,theMedfusion®Model4000pumpevaluationshaveincludedMagneticAttraction(projectilehazard),MRinterferencewiththepump,andMRImageDistortion.• MagneticAttraction(projectilehazard):The

Medfusion®Model4000pumpshowednoattrac-tiontorqueorforceat150gaussstaticmagnetic

fieldstrength.• MRInterferencewiththePump:TheMedfusion®

Model4000pumpoperatednormallywhileinthe150gaussstaticmagneticfield.

• MRImageDistortion:NoMRimaginginter-ferencewasobservedwhentestedwiththeMedfusion®Model4000pumpat8feetfromtheisocenterofa1.5T(64MHz)SiemensSymphonyMRsystem,SiemensSoftware2002RevisionC,underthefollowingconditions:batteryonly(noACcord),backofthepumpfacingtheMRIisocenter,fullbodyreceivercoil(mostsensitive),usingstandardspinecho,fastspinechoandgradi-entspinechopulsesequences.

Image DistortionCertainMRIreceivercoilsaresensitivetoelectronicemissions.Therefore,priortopatientexaminations,MRimagescansshouldbecompletedwhileoperat-ingtheMedfusion®Model4000pumpintheMRenvironmentthatistobeusedfortheexaminationtoverifyacceptableMRimagequality.NotethatresultsvarybetweenMRIsystemsduetodifferencesinscan-ningsystemsandreceiversused.Thefollowingaretipstominimizethepossibilityofimageartifactsappearing:• EnsurethatthebackofthepumpfacestheMRI

isocenterduringoperation(pumpscreenfacingawayfromtheMRI.

• MovethepumpfurtherfromtheisocenteroftheMRIsystemifimageartifactsappear.

• OperatetheMedfusion®Model4000pumponbatterypowerinanMRenvironment.Thepres-enceofapoweredACcordtypicallyinducesim-ageartifacts.

Furthermore,theMRItechnologistcanimprovetheSignaltoNoiseRatio(SNR)oftheimage,typicallyreducingoreliminatingimageartifacts,byadjustinganyofthefollowingvariables:• UsesignalrichpulsesequenceslikeSpinEcho

whereapplicable• DecreasethePhaseEncodingmatrix• IncreasetheacquisitionFieldofView• Increasetheslicethickness• Increasethenumberofaverages


141

Cleaning and careBelowarecommonmethodsandcautionsrelatingtocleaningandcaringfortheinfusionpump.

WARNING: Power Source:Toavoidelectricshock,beforecleaning,alwaysswitchelectricallyoperatedequipmentoffanddisconnectfromACpowersource.

CAUTIONS: • AvoidUsingSolvents:NEVERuseorganicsol-

vents(e.g.,acetone),quarternaryammoniacom-pounds,strongacids,orbasestocleananyportionofthepump.

• SprayResistant:Thepumpis“sprayresistant”fromthetopandsidesbutnot“waterproof ”.NEVER spraycleaningorotherfluidsdirectlyintoopeningsonthebottomofthepump.

• NotWaterproof:Thepumpisnotcertified“waterproof ”.Neverimmersethepumpinwaterorotherfluids.

• AvoidOilSprays:NEVERuselightoilsprays(e.g.,WD40®)tocleanorlubricatepump.Theseoilscontainchemicalsthatcandamagetheplasticofthepump.Nouser-added lubricationisnecessary.

• NeverAutoclave:NEVERsterilizethepumpinasteamautoclaveorgas.Usingautoclaveorgassterilizationcanseriouslydamagetheinfusionpumpandvoidthewarranty.

1. Followyourinstitution’sguidelinesforcleaninganddisinfectingofdevices.Thepumpcanbesafelycleanedwiththefollowingagents:• Commonbleach10%solutiondiluted

withwater.• Milddetergentmixedwithwater.• Isopropylalcohol70%solution.

2. Forbestresults:cleanbysprayingcleanserdirectlyontoasoftclothandthenwipingsurfacesdry.


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Maintenance & serviceThischapterincludesinformationrelatingtobothstandardmaintenanceandservice.

WARNINGS: • PumpMaintenance.Toavoidelectricshock,only

trainedbiomedicalservicepersonnelmayservicethispump.ServicepersonnelshoulddisconnecttheACpowercordbeforeservicingthepump.

• ShockHazard:TheonlymeansofremovingACpoweristodisconnecttheACpowercord.WhiletheACpowercordisattachedtothepumpandpluggedintoanACoutlet,livemainvoltageispresentwithinthepump.

• ManufacturerRecommendedMaintenance:Alwaysmaintainthispumpfollowingmanufac-turer recommended instructionsintheServiceManual.Improperlymaintainedpumpsmaycauseeitherunder-infusionorover-infusiontopatient.

• NeverOpenthePumpCase:Toavoidelectricshock,usersshouldneveropenthepumpcaseorbatterycompartmentforanyreason.ServicepersonnelshouldalwaysdisconnecttheACpowercordbeforeservicingthepump.

• DroppedorDamagedPumps:Neveruseadroppedorobviouslydamagedpump.Withdrawitfromserviceuntilatrainedbiomedicaltechniciancantestit.

Periodic maintenanceTrainedbiomedicalservicepersonnelshouldtestthepumpatleastyearlytoensurecontinuedsafeopera-tion.

• Thistestingshouldbeperformedatleastyearly,orwheneverthepumphasbeendamagedordropped.

• Theocclusionandother sensorsmustbecheckedyearly.

• RefertotheTechnical Service Manualforspecificdetails.

ThePharmGuard® Toolbox 2 User's Manual(providedwiththePharmGuard®Toolbox2software)providesinformationoncustomizingthesettingsandfeaturesofthepump,whichinturnaffecttheuseandopera-tionofthepumponadailybasis.TheMedfusion® Model 4000 Series Technical Service Manual,(partnumber67-2452-51)providestechnicalinformationonthispump,including:• FunctionalDescriptions • Calibration• TheoryofOperation • ServiceParts*• DiagnosisandTestingContactSmithsMedicalforavailability.*Includingreplacementbatterypacksandpowercords


143

Using Smiths Medical USA service assistanceUsethefollowingstepstomakeuseofSmithsMedicalUSAserviceassistance:

1. ContacttheSmithsMedicalServiceDepartment(USA)atoneofthefollowingtelephonenumbers:

Toll-free in the U.S. 1800.258.5361Outside the U.S. 1214.618.0218

2. Whencallinganyofthesenumbers,pleasehavethefollowingready:• Modelname/numberofpump• Pumpserialnumber• Purchasedateifpumpiswithin

warrantyperiod• Descriptionofprobleminasmuch

detailaspossible3. Theservicerepresentativemay“talkyou

through”toasolutionifpossible.ComponentpartssuchastheinternalbatterycanbeorderedfromSmithsMedicalServiceandRepair.

Note:IfoutsidetheUSA,contactyourlocaldis-tributorforserviceassistance.


144

Returning a pump to the USA for repairWhentheservicerepresentativecannotresolveanissueoverthephone,thenitbecomesnecessarytoreturntheinfusionpumpforservice.

1. IftheproblemcannotberesolvedthroughthetelephoneassistanceoftheServiceDepartment,obtainaReturnAuthorization(RA)numberbycallingCustomerServiceat1800.258.5361(USA).CustomerServicehoursofoperationareMondaythroughFriday,7:00AMto5:30PMCST.

2. CleananddecontaminatethepumpandaccessoriespriortoreturningitemstoSmithsMedical.ThisisrequiredbeforeshipmentaccordingtoUnitedStatesOccupationalSafety&HealthAdministration(OSHA)regulations.

3. Packagetheinfusionpumpcarefullyforshipment.

4. SmithsMedicalwillnotacceptreturnsforservicewithouttheassignedRAnumberclearlyprintedontheshippingpackage.MarktheRAnumberclearlyontheoutsideoftheshippingpackageusedtoreturnthepump.

5. Shipthecarefullypackagedinfusionpumpto: SmithsMedicalASD,Inc.

1265GreyFoxRoadSt.Paul,MN551121800.258.5361(USA)www.smiths-medical.com

Note:Unlessaccessoryitems(suchasthepoleclamp,ACpowercord,etc.)arespecificallypartoftheproblemencountered,removeallaccessoryitemsfromthepumpbeforereturningittoSmithsMedical.


145

Collect Separately

WARNING: Collect Separately.Therearepotentialhealthhazardsassociatedwithimproperdisposalofbatteries,electronics,andcontaminated(used)in-fusionsetsandsyringes.Disposeofusedbatteries,infusionsets,syringes,andotherusedaccessories,orapumpthathasreachedtheendofitsusefullife,inanenvironmentallysafemanner,andaccordingtoanyregulationsthatmayapply.

Thisproductcontainselectricalandelectroniccom-ponents(includingbatteries)thatmaycontainmateri-alswhich,ifdisposedofwithgeneralwaste,couldbedamagingtotheenvironment.InaccordancewithDirective2002/96/ECWasteElectricalandElectronicEquipment,residentsoftheEuropeanUnionmustfollowspecificdisposalorrecy-clinginstructionsforthisproduct.Contactyourlocaldistributor,orvisitthefollowingwebsiteforspecificinstructions:http://www.smiths-medical.com/recycle/index.htmlNon-EuropeanUnionresidentsmustdisposeoforre-cyclethisproduct(includingbatteries)inaccordancewiththelocallawsorregulationsthatapply.


146

Limited WarrantySmithsMedicalASD, Inc. (the “Manufacturer”)warrants to theOriginalPurchaser that theMedfusion® Syringe InfusionPumpModel4000(the“Pump”),notincludingaccessories,shallbefreefromdefectsinmaterialsandworkmanshipundernormaluse,ifusedinaccordancewiththisOperator'sManual, foraperiodofone(1)yearfromtheactualdateofsaletotheOriginalPurchaser.THEREARENOOTHERWARRANTIES.

Thiswarrantydoesnotcovernormalwearandtearandmainte-nance items, and specifically excludes batteries, administrationsets, extension sets or any other accessory items or equipmentusedwiththePump.

Subject to the conditions of and upon compliance with thisLimitedWarranty, theManufacturerwill repairor replaceat itsoptionwithoutcharge (except foraminimalcharge forpostageandhandling)anyPump(notincludingaccessories)whichisde-fectiveifaclaimismadeduringsuchone-yearperiod.

Thefollowingconditions,procedures,andlimitationsapplytotheManufacturer’sobligationunderthiswarranty:

A. Parties Covered by this Warranty:This warranty extendsonlytotheOriginalPurchaserofthePump.Thiswarrantydoesnot extend to subsequent purchasers. The Original Purchasermay be a patient, medical personnel, a hospital, or institutionwhichpurchasesthePumpfortreatmentofpatients.TheOriginalPurchasershouldretaintheinvoiceorsalesreceiptasproofastotheactualdateofpurchase.

B. Warranty Performance Procedure:Noticeoftheclaimedde-fectmustbemadeinwritingorbytelephonetotheManufacturerasfollows:CustomerServiceDepartment,Smiths Medical ASD, Inc.,1265GreyFoxRoad,St.Paul,MN55112USA,1800.258.5361(USA)orSmiths Medical International Ltd.1500,EurekaPark,Lower Pemberton, Ashford, Kent, TN25 4BF,UK, +44 (0)1233722100.NoticetotheManufacturermustincludedateofpurchase,modelandserialnumber,andadescriptionoftheclaimeddefectinsufficientdetailtoallowtheManufacturertodetermineandfa-cilitateanyrepairswhichmaybenecessary.AUTHORIZATIONMUSTBEOBTAINEDPRIORTORETURNINGTHEPUMP.Ifauthorized,thePumpmustbeproperlyandcarefullypackagedandreturned to theManufacturer,postageprepaid.Any lossordamageduringshipmentisattheriskofthesender.

C. Conditions of Warranty:ThewarrantyisvoidifthePumphasbeen1)repairedbysomeoneotherthantheManufactureroritsauthorizedagent;2)alteredsothatitsstabilityorreliabilityisaffected(whichincludesuseofservice/replacementpartsnotsup-plied by SmithsMedical or its authorized agents, including thebatterypack);3)misused;or,4)damagedbynegligenceoracci-dent.Misuseincludes,butisnotlimitedto,usenotincompliancewiththeOperator'sManualorusewithnon-approvedaccessories.Removalordamage to thePump’s serialnumberwill invalidatethiswarranty.

D. Limitations and Exclusions: Repair or replacement of thePumporanycomponentpartthereofistheEXCLUSIVE remedyofferedbytheManufacturer.Thefollowingexclusionsandlimita-tionsshallapply:

1. Noagent,representative,oremployeeoftheManufacturerhasauthoritytobindtheManufacturertoanyrepresentationorwarranty,expressedorimplied.

2. THEREISNOWARRANTYOFMERCHANTABILITYORFITNESSORUSEOFTHEPUMPFORANYPARTICU-LARPURPOSE.

3. ThePumpcanonlybeusedunderthesupervisionofmedi-calpersonnelwhoseskillandjudgmentdeterminethesuitabil-ityofthePumpforanyparticularmedicaltreatment.

4. Allrecommendations,information,anddescriptivelitera-turesuppliedbytheManufactureroritsagentsarebelievedtobeaccurateandreliable,butdonotconstitutewarranties.

E. Computer Program License:

1.ThePumpisintendedtobeusedinconjunctionwithapar-ticularLicensedComputerProgramsuppliedbyManufactureranduseofanyotherprogramorunauthorizedmodificationofaLicensedComputerProgramshallvoidManufacturer’swar-rantyassetforthabove.

2.TheOriginal Purchaser and any users authorized by theOriginal Purchaser are hereby granted a nonexclusive, non-transferable license to use the Licensed Computer Programonly in conjunction with the single Pump supplied byManufacturer.The Licensed Computer Program is suppliedonlyinmachine-readableobjectcodeformandisbaseduponManufacturer’sproprietaryconfidentialinformation.Norightsaregrantedunderthislicenseorotherwisetodecompile,pro-ducehumanlyreadablecopiesof,reverseengineer,modifyorcreateanyderivativeworksbasedupontheLicensedComputerProgram.

3. All other terms and conditions of this LimitedWarrantyshallapplytotheLicensedComputerProgram.

The Manufacturer disclaims responsibility for the suitabil-ityof thePumpforanyparticularmedical treatmentor foranymedical complications resulting from theuseof thePump.TheManufacturershallnotberesponsibleforanyincidentaldamagesorconsequentialdamagestoproperty,lossofprofits,orlossofusecausedbyanydefectormalfunctionofthePump.

Thiswarranty gives theOriginalPurchaser specific legal rights,andtheOriginalPurchasermayhaveotherlegalrightswhichmayvaryfromstatetostate.


147

IndexA

ACpowerconnectionport9,111Alarms&alerts99Troubleshooting103Update(s)AvailableNotification110

BBattery111BatteryAlarms107guidelines112Onscreenpowergauge112

Bodyweight/surfaceareainfusions46Bolusdosing62Bolusratereduction66,106Continuing/restartingabolusdose65

CChangingrate94duringdelivery94whenpaused95

Cleaningthepump141Communication123,140Concentrationanddosingunits133Configuration6,12,134Configurationprofile30Continuingabolusdose65Continuingaloadingdose70Continuousmode:ml/hr39

DDataHandlingSoftwareSafetyFeatures128Delayedstart78,87Deliveringaloadingdose69Deliverymode33Display8Dose/Day42Dose/Hr40Dose/Min40Dose/Time44

EECMO(ExtracorporealMembraneOxygenation)7ElectromagneticCompliance(EMC)116EthernetState11EthernetPort9

Explosionriskwarning1

FFlowSentryrapidocclusiondetection6,92Flushfeature88,135

GGeneralUseDiagram23

HHardlimits14,19,133Hardware-relatedSoftwareSafetyFeatures128hyperbaricchamberusewarning1

IIntermittentvolume/time55

KKeepVeinOpen(KVO)rate74Keypad9buttons(orkeys)10Indicators10

Keypadlock98Unlocking98

LLibrariesQuick15Standard15

Loadingasyringe34Unloadingasyringe38

Loadingdose67Continuing/restartingaloadingdose70Deliveringaloadingdose69Loadingdoseratereduction71

Lockingthekeypad98

MMaintenance&service142Mode14,33Bodyweight/surfaceareainfusions46Continuous39Dose/Day42Dose/Hr40Dose/Min40Dose/Time44IntermittentVolume/Time55Recalllastsettings57Volume/Time54

MRI(MagneticResonanceImaging)140


148

NNearemptyalarmtone,disable/enable84Networkstatus11

OOcclusionsettings92Postocclusionbolusreduction93

Options61,136Bolusdosing62Delayedstart78,87Disable/enablenearemptyalarmtone84Disable/enablerapidocclusiondetection84Disable/enablevolemptyalarmtone85KVO(KeepVeinOpen)74Loadingdose67Deliveringaloadingdose69

Overridealarmloudness83Overrideocclusionlimit82Perioodiccallbackalarm79Standby76

Overridealarmloudness83Overrideocclusionlimit82

PPeriodiccallbackalarm79PharmGuardSafetySoftware6,15,19,31,133PharmGuardServer11Poleclamp113rotating/detachablepoleclampAssembling114

StationarypoleclampAssembling115

Postocclusionbolusreduction93Primefunction36,57ProgramDoseDelivered(PDD)96Clearing97Displaying96

ProgramVolumeDelivered(PVD)96Clearing97Displaying96

QQuicklibraries15

RRapidocclusiondetection,disable/enable84Ratereduction66,71,106Recalllastsettings57Restartingabolusdose65Restartingaloadingdose70

SSelf-tests26Service142Softlimits14,19,133SoftwareSafetyFeatures128DataHandlingSoftwareSafetyFeatures128Hardware-relatedSoftwareSafetyFeatures128

Standardlibraries15Using16

Standby76,87Startinganinfusion86frompause86fromstandby,delayedstart87Stoppinganinfusion87

Stoppingdelivery87Symbols5Syringebarrelclamp8,35,36Syringebarrelflangeclip8,35Syringemanufacturer/type39Syringeplungerdriver8,36Syringeplungerholders8Syringeplungerreleaselever8,35,36SystemAdvisory107SystemFailures102,108

TTechnicalspecifications124Concentrationanddosingunits133Flowdeliverygraphs(trumpetcurves)138Options136PharmGuardlimits133

TotalVolumeDelivered96Clearing97

Trumpetcurves(flowdeliverygraphs)138Tubingholders8,37Turningthepumpoff27

UUnloadingasyringe38Unlockingthekeypad98Update(s)Available110UserCallbackalarm101

VVolEmptyalarmtone,disable/enable85Volume/time-ml/hrinfusions54

Wwatchdog128WirelessState11WorkflowProcess23

s

Smiths Medical ASD, Inc.St. Paul, MN 55112 USA1 800.258.5361 (USA), 1 214.618.0218www.smiths-medical.com

@Smiths Medical International Ltd.TN25 4BF, UKTel: +44 (0)1233 722100

AusSmiths Medical Australasia Pty. Ltd.61 Brandl StreetEight Mile Plains, QLD 4113, Australia+61 (0) 7 3340 1300

Medfusion, PharmGuard, FlowSentry, and the Medfusion and Smiths Medical design marks are trademarks of Smiths Medical. The symbol

® indicates the trademark is registered in the U.S. Patent and Trademark Office and certain other countries. All other names and marks are trademarks, tradenames, or service marks of their respective owners.

This product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit. (http://www.openssl.org)

This product includes cryptographic software written by Erc Young ([email protected]).

© 2010-2011 Smiths Medical. All rights reserved.2011-09 40-5760-51A

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