Medfusion® Syringe Pump Model 3500 Operator's Manual

Medfusion® Syringe PumpModel 3500

Operator’s ManualSoftware Version 6

This manual and its contents are valid for use with software Version 6 (V6)

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Medfusion® Model 3500 pump V6 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 op-eration of the Medfusion® Syringe Pump Model 3500 Version 6 (Medfusion® Model 3500 pump V6), please call the appropriate number given below. When call-ing, please specify the 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 3500 pump V6.Smiths Medical ASD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 USA1 800.258.5361 (USA), +1 214.618.0218www.smiths-medical.comA printed copy of this manual is available upon request.


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Table of ContentsImportant Safety Information 1Warnings ................................................................................... 1Cautions .................................................................................... 3Symbols ..................................................................................... 4Introduction 5Indications for use ................................................................... 5Contraindications .................................................................... 6About the pump 7Features and Controls ............................................................. 7

Keypad closeup .................................................................. 8Pump Customization and General

Programming 10Custom Configuration .......................................................... 10General Programming .......................................................... 12Exceeding limits..................................................................... 12How pump settings and limits are prioritized ................... 12User defined pump Configurations .................................... 13

What are Configurations? ............................................... 13When are Drug Programs used? .................................... 13Who can use these Drug Programs? ............................. 13Types of programmable Library Categories ................. 13

Using a Custom Configuration ............................................ 14Using Quick Libraries ........................................................... 15PharmGuard® Safety Software: Dose Protocol

Protection .................................................................... 17Soft limits .......................................................................... 17Hard limits ........................................................................ 17

Adjusted limits in reverse ........................................... 18Overridden limits in reverse ...................................... 18Invalid infusion parameter combination ................. 18

PharmGuard® Supported Syringes (PSS) Series 2 ............. 19Navigating the pump menus ................................................ 20

The Workflow Process ..................................................... 20Guidelines for enhanced pump performance 22Always use the smallest syringe for volume of fluid

being delivered ........................................................... 22Bolus Volume ......................................................................... 23Use appropriate internal diameter tubing .......................... 23Programming an Infusion 24Turn the pump on ................................................................. 24

Turning the pump off ...................................................... 25Selecting a Delivery Mode and Programming an

infusion ....................................................................... 26General Infusion Programming Procedure ................. 27

Selecting an Infusion ............................................................. 28Select a Profile (Custom Configuration) ...................... 29

Select a Category ......................................................... 30Select a Drug Program ............................................... 30

Select a Delivery Mode (Medfusion® Standard Configuration) ............................................................. 31

Loading a syringe and syringe model setup ....................... 32Unloading the syringe ................................................ 36

Programming Infusions........................................................ 37

Continuous mode: mL/hr .............................................. 37Dose / Min and Dose / Hr .............................................. 38Dose / Day ........................................................................ 40Dose / Time ...................................................................... 42Body weight/surface area infusion deliveries .............. 44Volume / weight infusions .............................................. 46Dose/kg/time (dose/m2/time) ........................................ 48Volume / weight / time .................................................... 50Volume / time ................................................................... 52Intermittent volume / time ............................................ 53Recall last settings ............................................................ 55

Priming the system ................................................................ 57Options 59Bolus dosing ........................................................................... 60

Bolus programming......................................................... 60Bolus delivery ................................................................... 62

Continuing an interrupted bolus dose ..................... 63Bolus dose rate reduction ............................................... 64

Loading doses ........................................................................ 66Set up loading dose .......................................................... 66Delivering a loading dose ............................................... 68

Continuing an interrupted loading dose ................. 69Loading dose rate reduction ........................................... 70

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™ pressure monitoring ...... 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

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

FlowSentry™ pressure monitoring (rapid occlusion detection) ..................................................................... 92

Post occlusion bolus reduction ..................................... 93Making changes during delivery ......................................... 94

Changing delivery rate .................................................... 94


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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

Battery and AC power operation 110On screen display of internal battery power level

gauge .......................................................................... 111Battery guidelines ......................................................... 111

Poleclamp use 112Rotating/detachable poleclamp (standard) ...................... 112

Assembling the rotating/detachable poleclamp......... 113EMC information for the Medfusion® Model 3500

pump V6 ................................................................... 114Use of cables ................................................................... 114Stacked equipment ........................................................ 114

Technical specifications & other information 115Pump development standards ........................................... 115

Medical Electrical Equipment Safety .......................... 115Electromagnetic Compatibility .................................... 115Miscellaneous Standards ............................................... 116Compliance using: ......................................................... 118

Technical specifications ...................................................... 122Specifications .................................................................. 122

Safety Features 126Safety Features and Fault Detection .................................. 126

Hardware Safety Features ......................................... 126Software Safety Features ..................................................... 126

Hardware-related Software Safety Features ........... 126Program Memory - Check FLASH memory

POST or BGND ..................................................... 126RAM Memory Check - RAM BGND .................... 126Motor Circuit Check - pump motor phase A or B

POST and Motor rate error during operation ... 126Keyboard Encoder Check - Control key POST or

BGND .................................................................... 126Data Handling Software Safety Features .......................... 126

Data Stored in EEPROM - Critical data POST or EEPROM timeout or Primary/Secondary critical data corrupted .......................................... 126

Data Used in Calculations - Critical data failure .. 126Timer Data Registers - Time base BGND, time

of day clock POST, time of day clock timeout ... 127Additional Technical Information 128Medfusion® Standard Syringes ........................................... 128

PharmGuard® Supported Syringes (PSS) Series 2 ..... 128Flow rate & minimum volume by manufacturer & size - Standard syringes ................................................. 129

Concentration and dosing units ....................................... 131PharmGuard® software limits ............................................ 131Configuration options......................................................... 132

General Options ............................................................. 132Auto Prompt Options .................................................... 134Program Options ........................................................... 135Device Setup Features ................................................... 136

Flow Delivery Graphs ......................................................... 136Start-up curves over stabilization period ............... 137Trumpet curves over T2 period .............................. 137

Magnetic Resonance Imaging (MRI) Information ......... 138MRI Related Testing ...................................................... 138Image Distortion ............................................................ 138

Cleaning and care ................................................................ 139Maintenance & service ....................................................... 140

Periodic maintenance .................................................... 140Using Smiths Medical USA service assistance ........... 141Returning a pump to the USA for repair .................... 142

Collect Separately ................................................................ 143Limited Warranty 144Index 145

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Important Safety InformationWARNING: Read this entire manual before using the Medfusion® Model 3500 pump V6. 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 information 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 indicate 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,neverusethepumpin

the presence of flammable anesthetics, oxygen-enrichedatmospheres,orexplosivegases.

• Due to risk of explosion, never use this pumpinside a hyperbaric chamber. If the patient isplaced in a hyperbaric chamberwhile connectedto a pump located outside the chamber, deliveryaccuracycanbeaffected.DuetopressurechangesontheIVtubing,under-deliverycanoccurduringcompression,andover-deliverycanoccurduringdecompression.

• Medical Electrical Equipment needs specialprecautions regarding EMC and needs to beinstalledandputintoserviceaccordingtotheEMCinformationprovided.

• Portable and mobile Radio Frequency (RF)communications equipment can affect medicalelectricalequipment.

• This equipment/system is intended for use byhealthcareprofessionalsonly.

• The unauthorized modification of this productmayconstituteasafetyhazard,whichcouldleadtopatientinjuryordeath,aswellasthepotentialforpropertydamage (including the riskof fire).UseonlySmithsMedicalsuppliedservice/replacementparts, including the battery pack. Unauthorizedmodification and/or the use of unauthorizedservice/replacementpartswillalsovoidtheLimited

Warranty.• Before using anyMedfusion®Model 3500 pump

V6, users must be thoroughly familiar with thecontents of the operator’s manual, including allwarnings,cautions,andinstructionsforuse.

• The user should ensure that the performanceofferedbythepumpisfitfortheintendeduseandthat thepump isnotused in anywayor for anypurposeotherthanitsintendedpurpose.

• Thispumpisnottobeusedinanyintra-articularspaceinfusion.

• If the pump is used to deliver life-sustainingmedications,anadditionalpumpmustbeavailablefor situations where an interruption in infusioncouldbedangerous.

• Do not use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems wherethe negative pressure is greater than negative100mm Hg as the high negative pressures canresultinuncontrolledfluidflow.

• The pump must be positioned in an MRenvironment such that it is secured to a non-moveable objectandthemagneticfringefielddoes not exceed 150 gauss. Exposing the Medfusion®Model3500pumpV6tomagneticfieldsthatexceed150gausspresentsariskofbecomingaprojectilehazard and can lead topossiblepatient injuryordeath. Irreversible damage to the pump can alsooccur,renderingitinoperable.

• Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatadeliveryrateotherthanthatprescribedwillcauseinappropriatedelivery.

• Always read manufacturer precautions andguidelines for medications, fluids, syringesand administration sets used with this pump.Medicationsorfluidsmayinteractwiththeplasticcomponentsoftheinfusionsyringeandsets.

• OnlyusetheMedfusion®StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2,Version3, and included in the Medfusion® StandardConfiguration), or themodels and sizes availableas part of the PharmGuard® Supported Syringes

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Medfusion® Model 3500 pump V6 Operator’s Manual(PSS)Series2,andalwaysconfirmthatthesyringemodel and size displayed on the pump matchesthemodelandsizeloadedontothepump.Useofunapproved syringes may cause improper pumpoperationresultingininaccuratefluiddeliveryorocclusionsensingorotherpotentialhazards.

• Verifythattheplungerholderssecurelycapturethesyringeplunger.Makesuretocapturethesyringebarrel and flange. Failure to properly secure thesyringe could result inuncontrolledfluidflow tothepatient.

• AlwaysusethePrimefunctiononthepumpwhenloading a new syringe in order to remove anymechanical slack. Failure to prime correctly candelay infusion delivery and cause Total Volume Deliveredtoreadhigherthantheamountactuallydeliveredtothepatient.

• Periodically check the fluid pathway and allconnections(includingthecatheter/administrationsetconnection)forleaks.Leaksinthesystemmaycausefluidlossresultinginunder-delivery,aswellasallowinganopeningforcontamination.

• Alwaysturnofffluidflowtopatientintubingviaclampor stopcockbefore loadingorunloadingasyringe.Uncontrolled fluid flow can occurwheninfusionsetisnotclampedorturnedoffresultingininappropriatedeliveryrate.

• NEVER prime any syringe while connected toa patient infusion site, as this may cause over-infusion.

• Toavoidairembolism,alwayspurgeall air fromsyringeandinfusionlinesbeforeconnectingtothepatient.

• Once thesyringeandtubingsystemisconnectedtothepatient,raisingthesystemabovethepatient(even briefly) can cause significant bolusing dueto changes in hydrostatic pressure. Lowering thesystembelow thepatient (evenbriefly)cancausesignificantinterruptionsinflowduetochangesinhydrostatic pressure. This could cause improperpump operation resulting in inaccurate fluiddelivery.Place thepumpas close to thepatient’sinfusionsiteaspossible.

• Use the smallest syringe sizenecessary todeliverthe fluid ormedication. Using a large syringe atvery low rates (below Minimum RecommendedRate for the syringe)may cause improper pump

operation, delayed occlusion sensing, larger postocclusionbolusathigherocclusionlimitsettings,delivery inaccuracies, or other potential hazards.Bolus Volume:Deliveringabolusvolumelessthanthe recommended bolus volume for the syringeusedmay result in delivery inaccuracies. Use aninfusion set with the smallest diameter tubingavailable that does not result in excessive backpressureatthedesiredflowrate.Considerpriming,loading, bolus, and flush rateswhen selecting aninfusionset.

• LargersizesyringesatocclusionsettingHIGHmayproduceapostocclusionboluslargerthan0.3mLduetoexcessivesyringeplungertipcompliance.

• When using Quick libraries, preset values areautomatically inserted without pausing to verifyeachsetting.TheBegin Infusionscreendisplaysimmediately after selecting/confirming the drugprogram. Verify the infusion parameters beforestartingthedelivery.Certaindatafieldsmaynotbeprogrammed(e.g.patientweight)andrequiredataentrybeforetheinfusionwillproceed.

• If a system failure alarm occurs and cannot becleared by powering the pump down then backup,thepumpcannotbeused.Removeitfromuseandsendittoatrainedbiomedicaltechnicianforservice.

• Any external power source connected to theDCjack must be IEC 60601-1 certified for medicalequipment Type CF and meet Safety Class IIrequirements. Connecting any external powersource to theMedfusion®Model 3500 pumpV6createsamedicaldevicesystem.Therefore,theuseris responsible for compliance with IEC 60601-1standards(seeTechnicalSpecificationssectionforDCpowerrequirements).

• Electric Shock hazard.TheonlymeansofremovingAC power is to disconnect the AC power cord.WhiletheACpowercordisattachedtothepumpandpluggedintoanACoutlet,livemainsvoltageispresentinsidethepump.

• Ensure that the ± 2% accuracy specification (±syringe accuracy) is taken into account whenprogramming the pump and/or filling a syringe.Ifaccuracyisofprimeconcern,useonlysyringesthatmeetthe±2%requirementoftheISO7886-2Standard.Failuretodosomayresultinmedication

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Medfusion® Model 3500 pump V6 Operator’s Manualin the syringe becomingdepleted sooner or laterthanexpected.

• Use of cables other than as listed and withequipmentotherthanthosespecifiedmayresultinincreasedEMCemissionsordecreasedimmunityofthepump.

• Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.

• To avoid electric shock, before cleaning, alwaysswitch electrically operated equipment off anddisconnectfromACpowersource.

• To avoid electric shock, only trained biomedicalservice personnelmay service this pump. Servicepersonnel should disconnect theAC power cordbeforeservicingthepump.

• Alwaysmaintainthispumpfollowingmanufacturer recommended instructionsintheTechnical Service Manual.Improperlymaintainedpumpsmaycauseeitherunder-infusionorover-infusiontopatient.

• Toavoidelectricshock,usersshouldneveropenthepumpcaseorbatterycompartmentforanyreason.ServicepersonnelshouldalwaysdisconnecttheACpowercordbeforeservicingthepump.

• Neveruseadroppedorobviouslydamagedpump.Withdrawitfromserviceuntilatrainedbiomedicaltechniciancantestit.

• Therearepotentialhealthhazardsassociatedwithimproper disposal of batteries, electronics, andcontaminated (used) infusion sets and syringes.Disposeofusedbatteries,infusionsets,syringes,andotherusedaccessories,orapumpthathasreachedtheendofitsusefullife,inanenvironmentallysafemanner,andaccordingtoanyregulationsthatmayapply.

Cautions• Federal(USA)lawrestrictsthisdevicetosalebyor

ontheorderofaphysician.• ALWAYS verify that the software version of the

pump (displayed on screen during power-up)andOperator’s Manualarethesame.Refertothismanual’sfrontpage.

• NEVERusesharpobjectstodepresskeypadkeys

on the pump. This may damage the pump byrenderingkeypadkeysinoperable.

• Thispump isdesigned tobeused inahorizontalposition. If the pump is operated in any otherposition(includingvertical),thereisanincreasedpotential forfluid leaking into thepump. Iffluidleakageintoapumpissuspected,removeit fromuseuntilatrainedbiomedicaltechniciancantestit.

• Alwaysverifythestabilityoftheobjecttowhichthepumpismounted(forinstance,anIVpole)beforeusingthepoleclamp.Failuretoverifythestabilitycouldcausetheobjecttotip,withthepossibilityofcausingdamagetothepumpandotherequipmentIf the poleclamp is not adequately tightened, itcouldcausethepumptofall.

• DO NOT USEcleaningsolutionscontaining: acetone,ammonia,ammonium chloride(including

Hyamine1622),aromatic solvents(suchaspaintthinner,toluene,methylbenzene),chlorinated solvents(suchasmethylethylketone(MEK),trichloroethane),ether(suchasethyleneglycolmonobutylether,diethyleneglycolbutylether)oroxidizing acids(suchasphosphoricacid,sulfuricacidoracceleratedhydrogenperoxide).

Use of the solutions or solvents listed as DONOTUSE could damage plastic parts and causeprematurefailureordevicemalfunction.

• Use only the recommended cleaning/disinfecting agents and method. Use of cleaning/disinfectingagents and method other than those listed maycause damage to the pump and will void thewarranty.

• The pump is “spray resistant” from the top andsidesbutnot“waterproof”.NEVER spraycleaningorotherfluidsdirectlyintoopeningsonthebottomofthepumpaspumpdamagemayoccur.

• The pump is not certified “waterproof”. Neverimmersethepumpinwaterorotherfluidsasthiscanrenderthepumpinoperable.

• NEVERuselightoilsprays(e.g.,WD40®)tocleanor lubricate pump. These oils contain chemicalsthatcandamagetheplasticofthepump.Nouser-addedlubricationisnecessary.

• NEVERsterilizethepumpinasteamautoclaveorgas sterilizer.Using autoclave or gas sterilizationcanseriouslydamagethepumpandwillvoidthewarranty.

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SymbolsThefollowingisalistofsymbolswhichmayappearonthepump(oronitslabelingoraccessories),aswellascertaintechnicalterms,alongwithanexplanationofwhattheymean.

f Caution

7 Donotreuse

< Catalognumber

> Serialnumber

8 Useby

J DateofmanufactureH Manufacturer

nol Notmadewithnaturalrubberlatex

6 CAUTION:Federal(USA)lawrestrictsthisdevicetosalebyorontheorderofaphysician.

P Temperaturelimitation

_ Humiditylimitation

i Atmosphericpressurelimitation

J TypeCFequipment(protectionfromelectricshock)

Z CollectSeparately

K ClassIIEquipmentinwhichprotectionagainstelectricshockreliesondoubleorreinforcedinsulationinsteadofbasicinsulation.Accessiblemetalcomponentsofpumpenclosureusethishigherlevelofinsulationinsteadofsafetygrounding.ULMarkforCanadaandtheUnitedStates.IndicatestheproductwasmanufacturedinaccordancewiththerequirementsofUL(Underwriter’sLaboratory).

Ö ExternalDCjackconnection.Tip(negativesign)isforpowergroundandring(positivesign)isforpositivepowerconnection.

Ñ Symbolforinfraredserialcommunicationsportonpump

V ~ Operatingvoltagerangeforalternatingcurrent(i.e.ACormains)powersource

IPX3 Equipmentthatisingressprotectedfromfluidsprayingataverticalanglefromabove,andfromanglesto60°oneithersideofvertical

î Non-ionizingradiation

MR(MagneticResonance)Conditional

Ü PinsofconnectorsandotherareasidentifiedwiththisESDWarningsymbolshouldnotbetouched.ConnectionsshouldonlybemadewhenESDprecautionarymeasuresareused.

Foranexplanationofthesymbolsthatappearonthepumpkeypad,see“Keypad Closeup”andthetablesthatfollow(page8).

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IntroductionCAUTION: ALWAYSverifythatthesoftwareversionofthepump(displayedonscreenduringpower-up)andOperator’s Manualarethesame.Refertothismanual’sfrontpage.

TheMedfusion®Model3500pumpV6isasmall,lightweightandportablesyringeinfusionpump.Thepumpoffersavarietyofdeliverymodesprogrammabletomeetspecificpatientcareneeds.Theactualmodesavailableonagivenpump,andtheirlocationonagivenscreen,dependonthecustomsetup.Fluidscanbedeliveredfromavarietyofsyringesizes(1-60mL)andsyringemanufacturersinvariousdeliverymodes.TheMedfusion®Model3500pumpV6isequippedwithPharmGuard®MedicationSafetySoftware,anintuitivesystemdesignedtoenhancesafetywhilemaintainingsimplicity,whichcanallowstreamlinedimplementationandimprovedworkflow.ApumpConfigurationiscreatedonaPCusingthePharmGuard®Toolbox2,Version3software(PharmGuard®Toolbox2),andthentheConfigurationissenttothepump.TheConfigurationmaycontainglobalsettings,Profiledefinitions,librarydefinitions,DrugProgramsandsyringedefinitions(seepage13fordiscussionaboutlibraries).TheMedfusion®Model3500pumpV6importsandexportsdatatoassistinhistorydatamanagement.ThepumpcommunicatesviatheIRportontherearofthepump.PumpConfigurationsandfirmwarecanbeupdated,andinfusionsettingsandeventshistorydownloadedincombinationwiththePharmGuard®Toolbox2softwareapplication.ThepumpalsohastheFlowSentry™pressuremonitor(rapidocclusiondetection)feature,whichisacomprehensivearrayofpressure-relatedsafetyfeatures,includingrapidalarmresponseandreducedfalsealarms.Pressuretrendingisshowninthepumpdisplay,allowingearlieropportunitiesforintervention,aswellasapost-occlusionbolusreductionfeature.

Indications for useTheMedfusion®Model3500pumpV6isindicatedforthefollowinguses:

• Intheadministrationoffluidsrequiringpreciselycontrolledinfusionratesincludingbloodorbloodproducts,lipids,drugs,antibiotics,enteralsolutionsandothertherapeuticfluids.

• Bythefollowingdeliveryroutes:arterial,epidural,intravenous,intrathecal,subcutaneousandenteral.

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

• Incriticalcare,anesthesia,neonatalandpediatricapplicationsorotherhealthcaresettingswheretheuseofthesyringeinfusionpumpcanbemonitoredorsupervisedbyaclinician.

• InsidetheMRIroommountedoutsidethe150Gausslineandwithshieldedmagnetsoffieldstrengthof1.5Tesla.

WARNINGS:• Thisequipment/systemisintendedforuseby

healthcareprofessionalsonly.• BeforeusinganyMedfusion®Model3500pump

V6,usersmustbethoroughlyfamiliarwiththecontentsoftheoperator’smanual,includingallwarnings,cautions,andinstructionsforuse.

• Theusershouldensurethattheperformanceofferedbythepumpisfitfortheintendeduseandthatthepumpisnotusedinanywayorforanypurposeotherthanitsintendedpurpose.

• Thispumpisnottobeusedinanyintra-articularspaceinfusion.

• Ifthepumpisusedtodeliverlife-sustainingmedications,anadditionalpumpmustbeavailableforsituationswhereaninterruptionininfusioncouldbedangerous.

• ThepumpmustbepositionedinanMRenvironmentsuchthatitissecured to a non-moveable objectandthemagneticfringefielddoes not exceed 150 gauss.ExposingtheMedfusion®Model3500pumptomagneticfieldsthatexceed150gausspresentsariskofbecomingaprojectilehazardandcanleadtopossiblepatientinjuryordeath.Irreversibledamagetothepumpcanalsooccur,renderingitinoperable.

6


CAUTION: NEVERusesharpobjectstodepresskeypadkeysonthepump.Thismaydamagethepumpbyrenderingkeypadkeysinoperable.

• OnlytheMedfusion®StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2,andincludedintheMedfusion®StandardConfiguration),ortheadditionalsyringemodelsandsizesavailableaspartofthePharmGuard®SupportedSyringes(PSS)Series2(seepage19),maybeusedonthepump.

• Ensureallmedicationsorfluidsarecompatiblewiththesyringe,catheters,tubing,andfittingsusedintheinfusionsetup.

• Alwaysensurefluidsarecompatiblewitheachotherwheninfusingmorethanonefluidormedicationthroughthesameinfusionsite.Ifconnectingmorethanonepumptothesameinfusionsite,useone-waycheckvalvestopreventpumpsfrominterferingwitheachother.Verifythatthepumpswilloperatetogetherwithoutalarming.

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

7


About the pump

Features and ControlsFollowingareseveralillustrationsshowingthevariouscontrols,connectorsandfeaturesoftheMedfusion®Model3500pumpV6.

7 Syringe Plunger Driver:Onceloadedanddeliveryisstarted,thedriverpushestheplungerforwardatacontrolled,preciseratetodeliverfluid.

8 Syringe Plunger Release Lever:Squeezethereleaselevertoallowplacementofthesyringeplungerontotheholderduringloading,ortoremoveitduringunloading.

9 Keypad:SeeKeypadcloseup(page8)foridentificationoftheindividualkeypadkeysandwhattheyareusedfor.

10 AC Power Connection Port:PlugtheACpowercordintoconnectionporttoallowpumptooperateonAC(mains)power.

1 Display:pumpoperatingandstatusinformationappearsonthedisplay.Thelowerportionofthedisplaycorrespondswiththe4‘softkeys’(theirfunctionchangesdependingonthepumpprogrammingbeingaccomplished)onthekeypad.

2 Tubing Holders:Threadinfusionsettubingbetweenholderstopreventkinkingatsyringetip.

3 Carrying Handle

4 Syringe Barrel Clamp:Theclampholdsthesyringebarrelsecurelyinplace.

5 Syringe Barrel Flange Clip:Whenloadingasyringe,slidethesyringeflangeintotheclip.

6 Syringe Plunger Holders:Holdsthesyringeplungersecurelyinplace.

*

PRIME / BOLUS

*

8


11 Optional Poleclamp Mount:Ifdesired,attachtheoptionalpoleclamphere.

12 External DC Power Connector Port:PlugapprovedexternalDCpowersupplyintoport.

13 Infrared RS232 Connection Port:AlignRS232converterboxwithporttoallowuploadofdatafromanddownloadofdatatoapumpfromaPC.

Keypad closeup

9


Key When pump is paused When pump is delivering

Alarm Silence (í)Silencesaudiblealarm.Allowsoperatortoswitchthedisplaybacklightfrombrighttodimordimtobright.Allowsredisplayofthetextforthelastactivealarm.

Silencesaudiblealarm.Allowsoperatortoswitchthedisplaybacklightfrombrighttodimordimtobright.

Power (ë) Silencecertainactivealarms.Pushandholdtoturnpumpoff.

Silencecertainactivealarms(somealarmsmustbesilencedwithíbeforeëwillfunction).Pushandrelease,thenpushandholdtoturnpumpoff.

Menu keys (softkeys) Functionisdefinedonthedisplay. Functionisdefinedonthedisplay.

Back (â) Revertstoaprevioussteporlevel. Revertstoaprevioussteporlevelifadjustingsettings.BrieflydisplaysthebatterylifeindicatorandPDD/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)areonwheneverthepumpisinanalarmcondition.ThespecificdetailsofeachalarmarecoveredintheAlarmsectionlaterinthismanual.

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

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

ö - Lock TheLockindicatorindicatesthepumphasbeenlockedintoitscurrentoperationalmode.Whilethisindicatorislit,thekeypadislockedandnochangescanbemadetosettings.Attemptingtostoporchangeaninfusionwhilelockedwillresultinanalarmandaninformationalmessage.

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

10


Pump Customization and General Programming

Custom ConfigurationGenerallyspeaking,pumpcustomizationisperformedbeforeapumpisusedonapatient(seethediagramonpage11).CustomizationisaccomplishedusingPharmGuard®Toolbox2.OncethecustomConfigurationiscreatedandvalidated,PharmGuard®Toolbox2isusedtosendittothepump.Dependingonthesettingsandfeatureschosenincustomization,certainfeaturesmayormaynotbeavailablewhenprogramminganyspecificpump.Eachuserisresponsibletodeterminewhichfeaturesarepresentonthepumptheyareusingandtoprogramthemaccordingly.Forthisreason,thefollowingwarningisincludedthroughoutthestepsforprogramminganddeliveringfluidsthroughoutthismanual:

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

11


PharmGuard® Toolbox 2 CreateacustomConfiguration(settingsandDrugPrograms),validateConfiguration,thensendtopumpusingPharmGuard®Toolbox2(seetheproductliteraturesuppliedwiththeproductformore

information)

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® Model 3500 Pump V6“Medfusion®StandardConfiguration”includesmanualdeliverymodes,some

optionsandavarietyofsyringes.NoDrugProgramsareavailableintheStandard

Configuration

Medfusion® Model 3500 Pump V6WithCustomConfiguration

12


General ProgrammingTheMedfusion®Model3500pumpV6hasavarietyofdeliverymodesthatarecustomizablebytheuser.Theactualmodesavailableonagivenpump,andtheirlocationonagivenscreen,dependonthecustomsetupperformed.AllcustomizationisaccomplishedusingthePharmGuard®Toolbox2software,includingwhichsyringesandfeaturesareavailableonthepump,aswellashardandsoftlimitsonvalues(seebelowandpage17fordiscussionabouthardandsoftlimits).Themodesandprogrammingstepsdescribedinthischapter,andthestepsgivenforprogrammingthem,arebasedongeneralsetupparameters.Whichofthefeaturesandfunctionsareavailableonaspecificpump,andhowthescreensassociatedwiththemappear,dependsentirelyonhowthepumpwascustomized.Ifthefunctionsandscreensonapumplookdifferentthanthoseshownhere,itisduetothiscustomization.ItispossiblethatapumpiscustomizedsothataninfusioncannotbeprogrammedwithoutfirstenteringauserID,orsothatcertainprofilescannotbeaccessedwithoutfirstenteringapasscode.Ifthatisthecase,aprompttoenteranIDorapasscodeisdisplayedwhenattemptingtoprogramaninfusion.

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

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

under any conditions.HardlimitsshowupasMaxandMinonthepump.Ifanattemptismadetoexceedahardlimit,ascreensimilartothefollowingfiguredisplays.

BACKSPACE ENTER

INPUT OUT OF RANGE - GREATER THAN MAX VALUE

CLEAR

mL62DISABLE

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

Thepumpthenpromptsentryofanewvalue.• Soft Limits-The normal range.SoftLimitsshow

upasLowandHighonthepump.Theyarethenormalupperandlowerlimits.AvalueaboveorbelowtheLoworHighlimitcanbeentered(solongasitdoesnotexceedtheMinorMax).Ifthesoftlimitsareexceeded,thepumppromptstofirstsilenceanalarm,thenconfirmorcanceltheoverridecondition,asshowninthefollowingscreen.

NO

CONFIRM LIMIT OVERRIDE?

OVERRIDE

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

ItispossiblethatapumpiscustomizedsothatlimitscannotbeexceededunlessauserIDisentered.Ifthatisthecase,aprompttoenteranIDisdisplayed.“Limit”stylealertsareadvisoriesthatoccurforvariousreasons(usuallyduringprogramming).Anon-repeatingaudioalarmsoundsandamessageisdisplayedfor3seconds.Tore-displaythealertmessage,pressí.Thepumprecordsexceededlimitsandattemptstoexceedlimits.

How pump settings and limits are prioritizedTherecanbeanumberoflimitsimposedonpumpsettings,forinstancetherateislimitedbythesyringesizebeingused,aswellasanyhardand/orsoftlimitsimposedinthedrugprogram.Themostrestrictivelimittakespriority.Additionally,availableOptionsfordeliverycanbesetforprofilesaswellasindividualdrugprograms.Inthesecases,thesettingsforthedrugprogramtakepriorityoverprofilesettings.Forexample,theBolusoptionmaybeenabledforaprofile,butadrugprogramwithinthatprofilemayhavethebolusoptiondisabled.

13


User defined pump ConfigurationsThischapterdescribestheMedfusion®Model3500pumpV6Configuration.

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

When are Drug Programs used?Everyunit,department,organization,orhospitalhasstandardwaysofdeliveringmedicationsorfluids.Thecustomsetupenablestheuseofprogramsofstored presets.UsingthePharmGuard®Toolbox2Software,thePharmGuard®Toolbox2AdministratorwillestablishthepumpConfigurationthatimplementsthestandardinfusionsfortheunit,department,organization,orhospital.ThisprocessisdescribedinthePharmGuard®Toolbox2User’s Manual.

Who can use these Drug Programs?Anyonewhoisauthorizedtousetheinfusionpumpcanuseprogramsfromtheavailablelibraries.

Types of programmable Library CategoriesTherearetwotypesoflibrarycategoriesintheMedfusion®Model3500pumpV6:

Library Category Type

What it does

Standard Standardlibrarycategoriescontainprogramswithparametersthatareappliedwhenprogramminganinfusion.Theselibrariesrequiresteppingthroughandreviewingeachsetting.Thisallowsmodifyingstandardsettingswhilesteppingthroughpresetvalues.

Quick Aquickcategorycontainsdrugprogramswiththepresetsnecessaryforprogramminganinfusion.However,theydonotpauseateachlevelforentryofthesettings.Instead,the entire set of values is programmed at one step including syringe model and size.TheBegin Infusionscreen,whereallinfusionvaluesareshown,displaysatonce.Atthatpoint,confirmallthesettingsarecorrect,thenpressÉtobegindelivery.

WARNINGS: Confirm All Settings.Beforestartinganydelivery,alwaysconfirmtheaccuracyofallinfusionvaluestotheoriginalorder.Programmingthepumpatadeliveryrateotherthanthatprescribedwillcauseinappropriatedelivery,whichcanresultinseriousinjuryordeath.WhenusingQuicklibraries,presetvaluesareautomaticallyinsertedwithoutpausingtoverifyeachsetting.TheBegin Infusionscreendisplaysimmediatelyafterselecting/confirmingthedrugprogram.Verifytheinfusionparametersbeforestartingthedelivery.Certaindatafieldsmaynotbeprogrammed(e.g.patientweight)andrequiredataentrybeforetheinfusionwillproceed.

Displaying Quick library Options:Thestepsinthissectionarehypothetical.TheMedfusion®Model3500pumpV6isshippedwithaMedfusion®StandardConfiguration,andwithoutanyProfiles,CategoriesandDrugPrograms.SotheactualQuicklibrariesavailabledependentirelyonthecustomConfigurationsenttothepump.

14


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(seepage30forafullexplanationofthisscreen).

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

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


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

15


Using Quick LibrariesSmithsMedicalshipstheinfusionpumpwiththeMedfusion®StandardConfigurationthatdoesnotincludeaQuickLibrary.Theprofiles,categoriesandcustomdrugprogramsavailableonapumpdependontheconfigurationsetupbythepersonresponsibleforcustomconfiguration.QuickLibrariesisanoptionthatcanbeset-upincustomconfiguration.ThisoptiondesignatesacategoryinaprofileasaQuickLibrary.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 Profilekeydisplayedonstandardlibrarycategoryscreens,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,thedrugprogramsinthedesignatedQuickLibrarywilldisplayonscreenafterthepumpisturnedonandcompletesitsselftests.)ThedrugprogramsinaQuickLibraryhavebeencustomizedwithdefaultvaluesforinfusionparametersthatmayinclude:syringemodelandsize,dose,volume,weight,deliverytime,etc.Settingdefaultvaluesinthecustomprogramallowstheusertoproceedfromthedrugprogramselectionscreentothefinalconfirmationscreen(providedtheloadedsyringematchesthedefaultsyringeinthedrugprogram).TheQuickLibraryprogram’spresetvaluesareloadedautomaticallyintothepumpprovided that you have loaded a syringe of the manufacturer and size programmed for this library entry.PressÉtobeginthepresetinfusionafterverifyinginfusionsettingsandusingthePrimefeature.Somedatafieldsmaybeblankandrequiredataentrytoproceed.

16


QUICK LIBRARY

CONC 10 mg/mL TVD 0 mLWEIGHT 75 KGLOAD 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


17


PharmGuard® Safety Software: Dose Protocol ProtectionPharmGuard®MedicationSafetySoftwareprovidesprogrammableHardandSoftupperandlowerlimitsforinfusionparameters.RefertothePharmGuard®softwarelimitsintheTechnicalSpecificationssectionofthismanual(page131)foralistofallparametersthatmaybeprotectedwithPharmGuard®softwarelimits.

Soft limitsSoftlimitsarethenormallimits,andshowonscreenasHighandLow.Softlimitscanbeexceeded(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,thevaluewillbeaccepted.IfNoispressed,thevalueentryscreenreappears.

Hard limitsHardlimitsaretheabsolutemaximumandminimumforavalue.WhenattemptingtoenterorchangeanumericinfusionparameterofadrugprogramtheHardlimitsaredisplayedonscreenas“MAX:”and“MIN:”values.ItisnotpossibletoexceedaHardlimit.

18


Adjusted limits in reverseDuringsetup,thepumpdeterminesabsoluteminimumsandmaximumsbasedonthephysicalabilitiesofthepump,suchassyringesize(amongotherthings).(Seethetableonpage129forminimumandmaximumflowrates.)IfthePharmGuard®softwarelimitsareoutsideofthepumplimits,thepumpadjuststhelimitsasappropriate.Whenthisoccurs,thelimitpriorityalarm“Limits Adjusted—Cannot Deliver All Doses”issounded.Whenthepumpadjustslimits,theyarereversehighlighted.

Overridden limits in reverseWhenasoftlimitisoverridden,asdescribedpreviouslyin“SoftLimits”,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,incertaincasesofan“Invalid Infusion Parameter Combination”alarmoccurs,itispossiblethatthedrugprogramcreatedinPharmGuard®Toolbox2issuchthatnovalidentryispossible,inwhichcaseyouwillneedtodocumenttheissueandrequestanupdateforcustomConfiguration.Itmaybeusefultocheckcalculationsusingacalculatorandformulatohelpidentifyissueswithinvalidinfusionparameters.Ifapumphasrecurringissueswithinvalidinfusionparameters,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

19


PharmGuard® Supported Syringes (PSS) Series 2Eachmanufacturedsyringehasuniquecharacteristics.Thesecharacteristicsdifferbymodelandsyringesize.TheMedfusion®Model3500pumpV6usesthespecificcharacteristicstoaccuratelydeliverfluid.IncludedwithPharmGuard®Toolbox2areseveralcommonlyusedMedfusion®StandardSyringesSeries2forafacilitytochoosefrom.ThesesyringesarechosenforuseinaConfigurationviaPharmGuard®Toolbox2.PharmGuard®SupportedSyringes(PSS)Series2allowtheadditionofawiderangeofavailablesyringemodelsandsizestoPharmGuard®Toolbox2,foruseincreatingDrugPrograms.PSSSeries2filesmustbeaddedviaPharmGuard®Toolbox2whencreatingacustomConfiguration.ContactSmithsMedicalforacompletelistofavailablePharmGuard®SupportedSyringes(PSS)Series2.(TheMedfusion®StandardSyringeSeries2modelsandsizesarelistedintheTechnicalInformationsectionofthismanualonpage128.)Specifictechnicalinformation,includingsyringeflowrateandminimumvolume,isalsosuppliedintheliteratureaccompanyingPharmGuard®Toolbox2andthePharmGuard®SupportedSyringes(PSS)Series2.Refertowww.smiths-medical.comorcontactCustomerServiceformoreinformationaboutavailablePharmGuard®SupportedSyringes(PSS)Series2.

WARNING:OnlyusetheMedfusion®StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2,andincludedintheMedfusion®StandardConfiguration),orthemodelsandsizesavailableaspartofthePharmGuard®SupportedSyringes(PSS)Series2,andalwaysconfirmthatthesyringemodelandsizedisplayedonthepumpmatchesthemodelandsizeloadedintothepump.Useofunapprovedsyringesmaycauseimproperpumpoperationresultingininaccuratefluiddeliveryorocclusionsensingorotherpotentialhazards.

20


Navigating the pump menusTherearesomegeneralrulesfornavigatingpumpmenus.Mostofthepumpprogrammingstepsareaccomplishedbylookingtothedisplayscreen,andpressingthesoftkeysindicated.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.)Somemenusareverylargeandtherewillbemoreitemstochoosefromthancanfitonasingledisplayscreen.Inthosecasesoneofthesoftkeyswillbe“More”,indicatingtherearemoreoptionsavailableandMorecanbepressedtoviewthem.Onthosesortsofmenus,oncetheendofthechoicesisreached,theMorekeybecomesBeginning,indicatingBeginningcanbepressedtogobacktothefirst“page”ofthemenu.Ifamistakeismadeinprogramming,oramenuopenedaccidentally,pressâtoreturntoapreviousscreenormenu.

Legend

Inthismanual,menuinformationthatappearsonscreenisshowninboldandsmallcapitals(forinstance,Select the Profile).Textassociatedwithsoftkeysisshownasbold(forinstance,Enter).

The Workflow ProcessThebasicworkflowforprogramminganddeliveringaninfusionisshowninthediagramonthefollowingpage.Theinfusionmayconsistofseveraldistinctdeliveries,possiblyincludingaloadingdose,maininfusion,oneormorebolusesduringthemaininfusion,aswellasaflushorKVOinfusiononcethemaininfusioniscomplete.Itispossiblethatallofthesepartsareprogrammedintheinitialinfusionsetupsequence,ortheymayalsobeaddedatalatertime(aftertheinitialsetupbutbeforepressingÉtostarttheinfusion,orinsomecasesaftertheinfusionisstarted).Becausethepumphasmultiplecustomizablefeatures,actualDrugProgramsandmanualinfusionsmayhaveotherdeliveryoptionsandconfirmationscreensincludedthatarenotshowninthediagram.TheseadditionaloptionsandscreensaredependentonthecustomConfigurationcreatedinPharmGuard®Toolbox2.

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

21


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

22


Guidelines for enhanced pump performanceThefollowingareguidelinesforenhancedsyringepumpperformance.Reviewocclusiontimeandflowdeliverygraphs(startingonpage92).Useappropriatesyringesize,tubing,andinlinedevicesforexpeditingdeliveryofmedicationorfluid.Certainfactorsenhancesyringepumpperformance,whereperformanceisdefinedas:

a) TimetoDetectOcclusionb) ContinuityofFlowc) StartupTime

Always use the smallest syringe for volume of fluid being deliveredWARNING:Usethesmallestsyringesizenecessarytodeliverthefluidormedication.Usingalargesyringeatverylowrates(belowMinimumRecommendedRateforthesyringe)maycauseimproperpumpoperation,delayedocclusionsensing,largerpostocclusionbolusathigherocclusionlimitsettings,deliveryinaccuracies,orotherpotentialhazards.Bolus Volume:Deliveringabolusvolumelessthantherecommendedbolusvolumeforthesyringeusedmayresultindeliveryinaccuracies.Useaninfusionsetwiththesmallestdiametertubingavailablethatdoesnotresultinexcessivebackpressureatthedesiredflowrate.Considerpriming,loading,bolus,andflushrateswhenselectinganinfusionset.

Ifaccuracyisofprimeconcern,useonlysyringesthatmeetthe±2%requirementoftheISO7886-2Standard.Frictionandcomplianceofthesyringeplungertipaffectdeliverystartupandflowcontinuity.Thebiggerthesyringe,thegreaterthefrictionandcompliance,theslowerthestartup.Useasmallersyringewhenrunningatalowerrate.Thetablesonpage129showtherecommendedminimumdeliveryratesforthestandardsyringes(includedwithPharmGuard®Toolbox2)bysyringesize.SimilarinformationisprovidedinthedocumentationsuppliedwithPharmGuard®SupportedSyringes(PSS)Series2.When

programmingflowrates,alimitpriorityalarmwillbeactivated,alongwithanadvisorymessageonthescreen,ifaratethatfallsoutsidethoserecommendedisentered.

Note:• FlowSentry™pressuremonitoringisnot

availableforallsyringesizesortypes.CheckthedocumentationthatcamewiththeMedfusion®StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2)and/orPSSSeries2forinformationontheavailabilityofFlowSentry™pressuremonitoring.

• Fluidswithhigherviscositymaycausefalseocclusionalarmsatlowersettings.Wheninfusinghigherviscosityfluids,adjusttheocclusionalarmsettingtominimizefalseocclusionalarms.

• Ifaratebelowthatshownonthetablesonpage129orinthedocumentationsuppliedwiththePharmGuard®SupportedSyringes(PSS)Series2isentered,theRate Below Recommended Min for Syringe Sizealarmwilloccur(seepage105forafullexplanationofthealarm).Theabsoluteminimumrateallowedbythepumpwithagivensyringeislistedinthetablesfoundonpage129,andincludedintheliteraturesuppliedwiththePharmGuard®SupportedSyringes(PSS)Series2.

23


Bolus VolumeTherecommendedminimumbolusvolumeis1mLor10percentofthesyringevolumeofthesyringeused,whicheverisless.Inotherwords,fora1mLsyringe(regardlessoftheactualvolumeofmedicationcontained),theminimumrecommendedbolusvolumeis0.1mL.Fora60mLsyringe,therecommendedminimumbolusvolume(regardlessoftheactualvolumeofmedicationcontained),is1mL.Bolusvolumesdeliveredthatarelessthantherecommendedminimumbolusvolumesforthesyringeusedmayresultindeliveryinaccuracies.

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,itisrecommendedtouseappropriateinternal diameter tubing,aswellastominimize residual volumesbetweensyringeandpatientbyreducing:

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

b) Tubinglengthc) Sizeofin-linefiltersd) Numberofstopcocks

Thismakestheinfusionsetuplessvariableorcompliant,whichinturnreducesthestarttimeforfluidtoreachthepatient–andreducestimerequiredfordetectinganocclusionandmaintainsdeliveryaccuracy.Useonlythestandardsyringesspecifiedonthetableonpage128andsuppliedwithPharmGuard®Toolbox2,orsuppliedwiththePharmGuard®SupportedSyringes(PSS)Series2(availablefromSmithsMedical).SmithsMedicalalsoprovidesavarietyofinfusionsetsthatcanbeusedwiththepump.Seewww.smiths-medical.comforinformationregardinginfusionsetsavailablefromSmithsMedical,orcontactyoursalesrepresentative.

24


Programming an InfusionTurn the pump onBelowrightisanillustrationofastartupscreen,andalistofbasicstepsforturningtheinfusionpumpon.

1. Pressandholdëuntilthedisplayturnsdark.Verifythedisplayshowsallpixelson,thenallpixelsoff.

2. Thepump“beeps”twice,onelowbeepandonehighbeep.Thisisatestofthestandardaudiblealarmandthebatterybackupaudiblealarm(hightone).TheAlarm,InfusingandLockindicatorsflashastheself-testcyclesandthestartupscreenappears.TheDeviceID,ifithasone,appearsinthemiddleleftcorner.(Inthisexample,itiscalled“HOSPITAL”.)Thepumpserialnumberwillappearatthemiddleright(inthisexample,itis“M001234”).

3. Verifythedisplayindicatessuccessfulcompletionofsystemstartupself-tests.

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

IMPORTANT:DonotmovetheSyringePlungerDriverorotherwisemanipulatethepumpuntilthestartuptestsarecompleteandtheProfileselectionscreenappears.Sensorsaretestedaspartofthestartupprocess,andmanipulatingthepumpduringthisprocessmaycauseittodetectfalsesensorfailures,resultinginalarms.

VERIFYING CONFIGURATION

PHARMGUARD® MEDICATION SAFETYHOSPITAL VERSION V6.0.0 M001234CONFIG VERSION: 01.05.00002 CONFIG CRC: 4A4F

5 SECONDS REMAINING © 99-2013100%

25


Turning the pump offThepumpcanbeturnedoffatany time,inanydeliverymode,whilethepumpisrunning.

Note:Ifthereareanyalarmssounding,youmustfirstsilencethealarmbypressingíbeforethepumpcanbeturnedoff.

PRESS < POWER > AGAIN TO SHUTDOWN

CONC 1000 mcg/mL PDD 1.27 mLWEIGHT 10 KG

DOSE 15 MCG/KG/MIN RATE 9 mL/HrCONTINUE

N

With the pump infusing:1. Pressand holdë.

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

âispressed.)

2. Pressand holdëagaintoturnthepumpoff.TocancelpressContinueorâ.

Infusionstopswhenthepumpisturnedoff.With the pump stopped:

1. Pressandholdë.Thepumpturnsoff.

LOCK

CONC 1000 mcg/mL PVD 0.05WEIGHT 10 KG

DOSE 15 MCG/KG/MIN RATE 9

SHUTDOWN IN PROGRESS

CONC 1000 mcg/mL PDD 1.27 mLWEIGHT 10 KG

DOSE 15 MCG/KG/MIN RATE 9 mL/HrCONTINUE

N

DOBUTamine 1000 mcg/mL

26


Selecting a Delivery Mode and Programming an infusionDuetothecustomizationcapabilitiesoftheMedfusion®Model3500pumpV6,thescreenshownoncepower-upiscompletedependsentirelyonwhat,ifany,customizationwasperformed.TypicallyaCustomConfigurationwillhavebeencreatedusingPharmGuard®Toolbox2,andhavebeensenttothepump.IfaConfigurationwithProfileswassenttothepump,thepumpwillstopatthe“Select the Profile”Mainmenu.IfnoCustomConfigurationwassenttothepump,thepumpwillstopatthe“Medfusion®StandardConfiguration”Mainmenu.IftheCustomConfigurationsenttothepumpconsistsofonlyoneprofilecontainingaQuicklibrary,thepumpstopsattheQuicklibrarymenu.IfonlyoneprofileisprogrammedandQuicklibrarynotused,thepumpgoesrighttotheCategory/DeliveryModesscreen.Thegraphiconthefollowingpageshowsthegeneralstepsrequiredtoprogramandstartaninfusion.Specificinstructionsforprogrammingthevarioussettings,deliverymodesandoptionsfollows.

27


PRESS THE NUMBER TO SELECT

MORE

1 mL/Hr 5 RECALL LAST SETTINGS2 VOLUME/TIME3 DOSE/TIME4 DOSE / KG / MIN

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



28


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

29


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

30


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,2/8).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

31


DEXAmetHaSone 4 mg/mL

CONFIRM DRUG PROGRAM SELECTION? HEM/ONC

NOYES


MORE

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

Thepumprequiresaconfirmationfordrugprogramselections;pressYestoconfirmtheselection,orpressNotoreturntotheSelect screen.

If“manual”modesareavailableinthecustomConfigurationandselectedforaninfusion,thepumppromptsforaconfirmationaswell.PressYestoconfirmtheselection,orpressNotoreturntotheSelectscreen.Afteradrugprogramselectionismadethepumpwillprompttoselectthesyringemodelandsizebeforeprogrammingtheselectedmode(seepage32).Specificinformationforprogrammingthevariousdeliverytypesfollowstheinstructionsforthesyringe.

Select a Delivery Mode (Medfusion® Standard Configuration)

1 IfthepumpdoesnothaveacustomConfiguration,theMedfusion®StandardConfigurationmenudisplays.

2. Selectadeliverymodebypressingitsnumber.Ifthedesiredmodeisnotdisplayed,pressMoretodisplayadditionaldeliverymodes(ifpresent).

3. Thepumprequiresconfirmationofmanualmodeselection.PressYestoconfirmtheselection,orpressNotoreturntotheSelect screen.

Afteradeliverymodeselectionismadethepumpwillprompttoselectthesyringemodelandsizebeforeprogrammingtheselectedmode(seepage32).Specificinformationforprogrammingthevariousdeliverytypesfollowstheinstructionsforthesyringe.

mL / Hr

CONFIRM MANUAL PROGRAMMING / DELIVERY MODE?

NOYES

mL / Hr

CONFIRM MANUAL PROGRAMMING / DELIVERY MODE?

NOYES

32


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.

WARNING:OnlyusetheMedfusion®StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2,andincludedintheMedfusion®StandardConfiguration),orthemodelsandsizesavailableaspartofthePharmGuard®SupportedSyringes(PSS)Series2,andalwaysconfirmthatthesyringemodelandsizedisplayedonthepumpmatchesthemodelandsizeloadedontothepump.Useofunapprovedsyringesmaycauseimproperpumpoperationresultingininaccuratefluiddeliveryorocclusionsensingorotherpotentialhazards.

SELECT SYRINGE MODEL1 B-D2 MONOJECT3 TERUMO

CONFIRM

CONFIRM SYRINGE MODEL / SIZE / LOADING

B-D

¤

≤™

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

IMPORTANT:DonotmovetheSyringePlungerDriverorotherwisemanipulatethepumpuntilthestartuptestsarecompleteandtheProfileselectionscreenappears.Sensorsaretestedaspartofthestartupprocess,andmanipulatingthepumpduringthisprocessmaycauseittodetectfalsesensorfailures,resultinginalarms.

1. Inspectthesyringetoidentifythemodelandsize.

2. Pressanumberkeytoselectthesyringemodelbeingused.

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

3. Itisnowtimetoloadthesyringe.(Thearrowsshownonscreenindicatethatthesyringesensorsdetectthatthesyringeisnotloaded.)

33


4. LiftupwardontheSyringeBarrelClampandturnitsoitisoutoftheway.

5. SqueezethePlungerReleaseLeveronthesyringeplungerdriverandpullgentlytoextenditallthewayoutward.

WARNING: Verifythattheplungerholderssecurelycapturethesyringeplunger.Makesuretocapturethesyringebarrelandflange.Failuretoproperlysecurethesyringecouldresultinuncontrolledfluidflowtothepatient,whichcouldresultinseriousinjuryordeath.

6. Loadthesyringeontothepumpasillustrated,makingsuretheflangeofthesyringebarrelispressedorrolledintotheFlangeClip.

START

START

34


7. SqueezethePlungerReleaseLeveronthesyringeplungerdriverandpushittowardthesyringeplunger;onceitisflushwiththesyringeplungerreleasethelever.Besurebothholdersclosearoundthesyringeplunger.

8. TurnandlowertheBarrelClampontothebarrelofthesyringe.

WARNINGS:• Verifythattheplungerholderssecurelycapture

thesyringeplunger.Makesuretocapturethesyringebarrelandflange.Failuretoproperlysecurethesyringecouldresultinuncontrolledfluidflowtothepatient,whichcouldresultinseriousinjuryordeath.

• AlwaysusethePrimefunctiononthepumpwhenloadinganewsyringeinordertoremoveanymechanicalslack.FailuretoprimecorrectlycandelayinfusiondeliveryandcauseTotalVolumeDeliveredtoreadhigherthantheamountactuallydeliveredtothepatient.

Thesizeshouldnowappearinthedisplay.

Note:Ifthesyringeisincorrectlyloaded,guidearrowsappearonscreentoidentifytheproblem.

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.

35


Note:Somesyringesmayhavesimilarouterdimensions,despitebeingdifferentsizes(forexample,BD®1mLLuerLok™and3mLsyringes),orevendifferentmodels.Inthesecases,thepumpwilldisplaysizeoptions,requiringselectionofthecorrectsyringesizeactuallyinuse.Alwaysverifythatthesyringemodelshowniswhatisactuallyinuse(ifnot,pressâandselectthecorrectmodel).

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

WARNING:OnlyusetheMedfusion®StandardSyringesSeries2(suppliedwithPharmGuard®Toolbox2,andincludedintheMedfusion®StandardConfiguration),orthemodelsandsizesavailableaspartofthePharmGuard®SupportedSyringes(PSS)Series2,andalwaysconfirmthatthesyringemodelandsizedisplayedonthepumpmatchesthemodelandsizeloadedontothepump.Useofunapprovedsyringesmaycauseimproperpumpoperationresultingininaccuratefluiddeliveryorocclusionsensingorotherpotentialhazards.

10.ThreadthetubingthroughthethreeTubingHoldersonthetopleftsideofthepump.

WARNING: Periodicallycheckthefluidpathwayandallconnections(includingthecatheter/administrationsetconnection)forleaks.Leaksinthesystemmaycausefluidlossresultinginunder-delivery,aswellasallowinganopeningforcontamination.

11.PressConfirm toconfirmthesyringeinformation.

Thepumpwillnowautomaticallydisplaytheprogrammingscreensforthedeliverymodechosen.Sincetherearemanymodestochoosefrom,inwhichawidevarietyoffunctionswithinthatmodemayormaynothavebeenenabled,whatfollowsisanexplanationoftheprogrammingstepsrequired

1mL LL

SELECT THE SYRINGE

B-D

™

3mL

CONFIRM SYRINGE MODE / SIZE / LOADING

b-d 1mL LL

conFirm

36


foreachpossibledeliverymodewithallfunctionsenabled.

Unloading the syringe

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

Unloadasyringeexactlytheoppositewayasitwasloaded.Justusethefollowingsteps:

1. Pressátostopdelivery.2. Clamporcloseinfusionlinefromthe

syringetothepatient.3. UnthreadthetubingfromtheTubing

Holdersonthetopleftsideofthepump.4. LiftandswivelthesyringeBarrelClampout

oftheway.5. SqueezethePlungerReleaseLeveronthe

syringeplungerandremovethesyringe.

37


Programming InfusionsContinuous mode: mL/hrContinuousinfusionisprogrammedbysettingaflow rate in mL/hr.Actualrangelimitsforflowratearedeterminedbysyringemodelandsize(seethetableinTechnicalsection(page129)ofthismanualand/ortheproductliteraturesuppliedwithPharmGuard®Toolbox2orthePharmGuard®SupportedSyringes[PSS]Series2)orbyacustomconfiguredmaximumrate.Ifneeded,andiftheoptionshavebeenenabledusingPharmGuard®Toolbox2,avolumelimit,loadingdose,orbolusdosecanalsobeprogrammed.

ToprogramaContinuousmodeinfusion,attheselectionmenu,chooseml/hr(orchooseadrugprogramthatusesthecontinuousmodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32.

1. Usethenumberkeysand(ifneeded)thedecimalpointtosettheflowrate.PressClear toclearanentry.PressBackspacetoeraseacharacter.PressEnter toacceptthesetting.

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

3. Ifdesired,programaBolusDose,LoadingDoseorVolumeLimit(seeOptions,page59).

4. Priortoconnectingtothepatient,pressètoinitiatetheprimingsequence(page57).

5. Confirmthesettingsandstarttheinfusion,orusethefourmenusoftkeystomodifythesettings.


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.

38


Dose / Min and Dose / HrTheDose/Minand/orDose/Hrmodesmaybeavailableonapump.Programthembysetting:

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

• Drug concentration• Drug delivery units (i.e.,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(orchooseadrugprogramthatusestheinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32.

1. Usethenumberkeystoselectthemedicationconcentrationunits.(Theactualunitsavailableonapumpdependsonthecustomsetup.)PressEntertoacceptthemedicationconcentrationunits.

2. Usethenumberkeystosetmedicationconcentration.Concentrationislimitedto4digits.PressClear toclearanentry.PressBackspacetoeraseacharacter.PressEntertoacceptthesetting.

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,requiringconfirmationofallsettingsagainbeforebeginningtheinfusion).

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

39




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,orusethefourmenusoftkeysshownatrighttomodifythesettings.




9. Whenalldeliverysettingsareconfirmedascorrect,pressÉtobegininfusion.

40




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:



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,andloadthesyringeasinstructedonpage32.


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


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





CHG DOSEMAIN MENU

CONC 0.9 mcg/mL PVD 0 mL

DOSE 5 MG/DAY RATE 0.232 mL/Hr

41






42




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:



mEq,orUnits)

• Dose rate• Delivery Time

Attheselectionmenu,chooseDose/Time(orchooseadrugprogramthatusestheinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32.


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


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

5. Thetimesettingscreenappears.Pressthenumberkeystosetthetimeinhoursandminutes,thenpressEnter.


43




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., Standby, etc.). Clear Totals – clears total volume delivered, and PVD or PDD.

7. Confirmthesettingsandstarttheinfusion,orusethethreemenusoftkeysshownatrighttomodifythesettings.




44


Body weight/surface area infusion deliveriesThefollowingBodyweight/surfacearea-basedinfusiondeliverymodesmaybeavailableonapump: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,andloadthesyringeasinstructedonpage32.

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

45


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

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

6. Ifdesired(andiftheyareenabled),programaBolusDose,LoadingDoseorVolumeLimit(seeOptions,page59).





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 mcg/kg/Hr RATE 8 mL/Hr


46


Volume / weight infusionsThefollowingvolume/weightmodesmaybeavailableonapump:mL/kg/minandmL/kg/hr.Volume/weightinfusionratecalculationsallowprogrammingby:

• 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.Toprogramavolume/weightinfusion,attheselectionmenu,chooseeithermL/Kg/MinormL/Kg/Hr(orchooseadrugprogramthatusesthevolume/weightmodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32.

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,page59).



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

47







CHG DOSEMAIN MENU

PVD 0 mLWEIGHT 5 KG

DOSE 0.3 mL/kg/Hr RATE 1.5 mL/Hr


48


Dose/kg/time (dose/m2/time)Thebodyweight/surfaceareainfusiondeliverymodewill only be available on a pumpthroughcustomprogrammingofadrugprogramviaPharmGuard®Toolbox2(inotherwords,‘Dose/Kg/Time’and‘Dose/m2/Time’areneveravailableasmenuitems,theymustbeutilizedinthecreationofadrugprogram,whichisthensenttothepump).OncecreatedusingPharmGuard®Toolbox2,taughttoaMedfusion®Model3500pumpV6,andoncethedrugprogramhasbeenselectedfromthelibrary,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,andloadthesyringeasinstructedonpage32.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: 250

LOW: 100

CLEAR

mg / mL

BACKSPACE ENTER


HIGH: 10

LOW: 0.25

CLEAR

KG

BACKSPACE ENTER

ENTER DOSE - PRESS ENTER TO CONTINUE

HIGH: 500

LOW: 100

CLEAR

MG

BACKSPACE ENTER


HIGH: 250

LOW: 0.25

CLEAR

KG

49


BACKSPACE ENTER

ENTER DELIVERY TIME

HIGH: 00:30:00

LOW: 00:03:00

CLEAR

:0000:00H R : M I N : S E C


5. Toconfirmthesetting,pressYes.Tomakechangesbeforeconfirming,pressNo.AttheBegin Infusionscreenallvaluesaresetandthepumppauses(thepumpmaybeconfiguredwithadditionalconfirmationscreens,requiringconfirmationofallsettingsagainbeforebeginningtheinfusion).


7. Confirmthesettingsandstarttheinfusion,orusethemenusoftkeysshownatrighttomodifythesettings.



MAIN MENU

CONC 100 mg/mL TVD 0 mLWEIGHT 5 KG DOSE 250 MGTIME 00:15:00TIME REMAINING 00:15:00 RATE 10 mL/Hr

OPTIONS CLEAR TVD

amPiciLLin NICU Intermittent

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.

NO

CONFIRM SETTINGS?

YES

conc 100 mg/mLWeigHt 5 kg doSe 250 mg

time 00:15:00rate 1.5 mL/Hr

50


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,andloadthesyringeasinstructedonpage32.

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: 250

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

51


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,orusethemenusoftkeysshownatrighttomodifythesettings.



52


Volume / timeThevolumeovertimeratecalculationallowsprogrammingby:

• Dose Volume• Delivery Time

Thepumpcalculatesthecorrectflowratebydividingthevolumebythedeliverytime.Volumelimit,loadingorbolusdosecannotbesetinthismode.

ToprogramVolume/Time,chooseitattheselectionmenu(orchooseadrugprogramthatusesthevolume/timemodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32.

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

Note:Volumeislimitedto500mLregardlessofsyringesizeinuse,assomeinfusionsmayrequiremultiplesyringes.

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



5. Confirmthesettingsandstarttheinfusion,orusethethreemenusoftkeystomodifythesettings.



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.

53


Intermittent volume / time Intermittent Volume / Timemodeallowsspecificationofadelivery volumeforaspecific delivery time,afterwhichthedeliverystopsforaprogrammedinterval,thenthepatternrecycles.Inotherwords,thepumpdeliversforasetperiod,pausesasetperiod,theninfusesforasetperiod,andsoon.

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

• Thepatternrepeatsatthe“TimeBetweenStarts”interval.

BelowarethestepsforprogramminganIntermittentVolume/Timeinfusion.SelectIntermittent Volume / Timefromtheselectionmenu(orchooseadrugprogramthatusestheintermittentvolume/timemodeinfusiontype).Choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32.

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


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

3. Usethenumberkeystosetthetimebetweenstartsvalue.Maximumandminimumtimesarecalculatedforthedeliverytimeentered(minimumtimemustbeatleastoneminutelongerthanthedeliverytime;thepumpwillnotaccepttimebetweenstartsequaltoorlessthanthedeliverytime).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

54


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,orusethethreemenusoftkeysshownatrighttomodifythesettings.



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


Recall last settingsTheMedfusion®Model3500pumpV6willrecallthesettingsusedtorunthelastinfusion.

Note:Ifapumphasacustomconfiguration(createdusingPharmGuard®Toolbox2andtaughttothepump)theRecall last settingsfeatureisavailableonlyinthoseprofilesithasbeenincludedin.To use the feature, first enter the profile for the previous infusion.AnyoptionalVolumeLimit,KVO,BolusDoseorLoadingDosesettingsareretainedintheinfusionwhenthisfeatureisused.Allotheroptions(Standby,OverrideOcclLimit,etc.)arediscardedand

mustbereprogrammedfromtheOptionsmenuattheBegin Infusionscreen.Reusethesamedeliverysettingstorepeatanidenticaldosageofmedicationorfluidstoapatient(choosethesyringemodelandsize,andloadthesyringeasinstructedonpage32):

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

Whenselected,pressEntertoconfirmthesyringetypeandsizeifthesyringehasbeenreplaced.AfterthesyringehasbeenconfirmedtheContinue Same Infusion?screenappears.


3. IfNoispressed,thepumpreturnstotheMainmenutoselectadifferentDrugProgramormanualdeliverymode.

IfYesispressed,thepumppausesattheBegin InfusionscreenandPVDisnotcleared.Afterreviewingthesepreviouslyusedsettings,thepumppauses.TocleartheTVDandPVD/PDD,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

56



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

TVD and PVD/PDD Retention:ThepumpalsoretainsTVDandPVD/PDDfromthelastinfusion.Ifthesevaluesarenotwanted,theymustbemanuallyclearedbeforebeginninganewinfusion.

57


Priming the systemPrimingisoneofthefunctionsoftheBoluskey(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,andbeforedeliveryisstarted.ThemessageatthetopoftheBegin Infusionscreenwillalternatebetween“Press < «> Key To Begin Infusion”,and“Press < ««> Key To Prime”asaremindertoperformtheprimesequence.

WARNINGS:• NEVERprimeanysyringewhileconnectedto

apatientinfusionsite,asthismaycauseover-infusionwhichcouldresultinseriousinjuryordeath.

• To avoid air embolism,alwayspurgeallairfromsyringeandinfusionlinesbeforeconnectingtothepatient.

• Periodicallycheckthefluidpathwayandallconnections(includingthecatheter/administrationsetconnection)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,orthedefaultmaximumbolusrateforthesyringesizebeingused,whicheverislower.

PRESS AND HOLD < «« > KEY TO PRIME

PRESS EXIT WHEN PRIME IS COMPLETE

PRIMING VOLUME 0.00 mL

EXIT

58


WARNING: Oncethesyringeandtubingsystemisconnectedtothepatient,raisingthesystemabovethepatient(evenbriefly)cancausesignificantbolusingduetochangesinhydrostaticpressure.Loweringthesystembelowthepatient(evenbriefly)cancausesignificantinterruptionsinflowduetochangesinhydrostaticpressure.Thiscouldcauseimproperpumpoperationresultingininaccuratefluiddeliverythatcouldresultinseriousinjuryordeath.Placethepumpasclosetothepatient’sinfusionsiteaspossible.

Oncethesystemisprimed,connectthetubingtothepatientandbegininfusion.

59


OptionsOptionsgivesaccesstoprogramoptionsthataffectthecurrent 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.InthecaseoftheRecall Last Settingsfeature(seepage55),programmedOptionsforVolumeLimit,KVO,BolusDoseorLoadingDoseareretainedwhenRecall Last Settingsisused.Howeveroptionssuchas“Standby”,“OverrideOcclLimits”,etc.arediscardedwhenthepumpisturnedofforwhentheprogramisreturnedtotheMainmenu,andwouldneedtobereprogrammedattheBegin Infusionscreen,evenifRecall Last Settingswasusedtoaccessthatscreen.TheseoptionsareavailablewhenthepumpisattheBegin Infusionscreen(priortostartinganinfusion):• OverrideOcclusionLimit• OverrideAlarmLoudness• Disable/EnableNearEmptyAlarmTone• Disable/EnableVolumeEmptyAlarmTone• BolusDose• DelayedStart• KVO• PeriodicCallbackAlarm• ChangetoDose/ChangetoVolume• LoadingDose• Standby• VolumeLimit• Disable/EnableFlowSentry™Theseoptionsareavailablewhenthepumpisrunninganinfusion:• BolusDose• OverrideOcclusionLimit• OverrideAlarmLoudness• PeriodicCallbackAlarm• Disable/EnableVolumeEmptyTone

• Disable/EnableNearEmptyTone• ChangetoDose/ChangetoVolume• Disable/EnableFlowSentry™

Note:Customizationsettingsinindividualdrugprogramstakepriorityoverprofilesettingsastowhichoptionsareavailable.Forinstance,whileBolusDoseandLoadingDosemaybeavailableasoptionsinagivenprofile,individualdrugprogramswithinthatprofilemayhavetheseoptionsdisabled,andthereforetheywillnotbeavailablewhenusingthosespecificdrugprograms.

60


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

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

Bolus programmingIfprogrammingabolusattheBegin Infusionscreenorduringaninfusion:

1. PressOptions.

2. UsethenumberkeystochooseBolus Dose.

Steps3through5arethebolusprogrammingscreens.IfAutopromptisEnabledinPharmGuard®Toolbox2,theyarepartofthenormalinfusionprogrammingworkflow:

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

61


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.ThedefaultvalueforbolusdeliveryratecanbesetincustomconfigurationinPharmGuard®Toolbox2,orifnodefaultvalueisset,thepumpdefaultstothemaximumbolusrate.Maximum&minimumtimeiscalculatedfromthemaximum&minimumrateforthesyringesizecurrentlyinuseand/orthecustomsetupintheConfiguration.(IfusingamanualdeliverymodeandtheBolusTimefeaturehasbeendisabledthepumpwilldefaulttothemaximumbolusrate.)Whenthebolustimeiscorrect,pressEnter.

UsingPharmGuard®Toolbox2,itispossibletorestrictbolustimetominutesonly.Ifthatisthecasethescreenwilllooklikethis:

ItisalsopossibletospecifyanabsolutetimelimitusingPharmGuard®Toolbox2,inwhichcaseitcannotbechanged.

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

62


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?screenappears.Tobeginbolusdelivery,pressYes.Ifbolusdeliveryisnotdesiredrightnow,pressNo.Tochangethebolusamount,pressCHG Bolusandreprogramthebolus(items3through5intheprecedingsection).


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

IfNowaspressed,thepumpreturnstothedeliveryscreen.Notethatthebolusinformationappearsonthescreen.PressingèwillcausetheBegin Bolus Delivery?screentoreappear,wherebolusdeliverycanbestarted(seeabove).

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


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

63


Continuing an interrupted bolus doseShouldaHigh Priorityalarmoccurduringbolusdelivery,orifáorCancelarepressed,thebolusstops.Eithercontinuethebolusfromwhereitleftoff,orcancelthebolus.

1. Ifnecessary,pressítosilencethealarm.Troubleshootthealarmcondition.

2. PressÉ.

3. Either:• PressOptions,thenusethenumber

keystoselectBolus Dose.OR• PressÉ.

4. Tocontinuethebolusfromwhereitleftoff(deliveringonlywhatwasremaining),pressYes.

PressNotoexitthebolusscreen,cancelbolusdeliveryandreturntothemaininfusion.

CONTINUE SAME BOLUS? BOLUS 2 mg/kg DELIVERED 1.7770 mLREMAINING 02:52 MM:SS 17.7700 MGTOTAL BOLUS 80 MG RATE 130 mL/Hr

YES NO

OCCLUSION - CHECK INFUSION LINE ketamine 10 mg/mLBOLUS 2 mg/kg DELIVERED 1.7770 mLREMAINING 02:52 MM:SS 17.7700 MGTOTAL BOLUS 80 MG RATE 130 mL/Hr

CANCEL

LOCK

N


conc 10 mg/mL tvd 1.639 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

64


RESTRICTED FLOW - RATE REDUCED DELIVERINGBOLUS 2 mg/mL DELIVERED 5.7200 mLREMAINING 06:40 MM:SS 57.2000 MG RATE 130 mL/Hr

CANCEL

Bolus dose rate reductionTheincreaseddeliveryrateofabolusdosemaytriggeranocclusionalarm(dependingontheocclusionlimitsettingsinthepumpandtheresistanceintheline).Ifthisoccurs,thebolustimeisautomaticallyincreasedby30%,thusreducingthebolusrate.Thebolusratecontinuestobereducedandthebolustimeincreaseduntilresistanceisbelowthesetocclusionlimit.Iftheratereductionscannotsucceedindeliveringtheboluswithoutocclusionoccurring(ifthebolusratereducesbelowtheinfusionrate,orthebolustimeincreasespastthemaximumbolustime),thebolusiseventuallycancelled.Therecouldbeavarietyofreasonsforocclusionstooccur,including(butnotlimitedto)theocclusionlimitinuse,fluid/medicationviscosity,tubingsize,thepatient’sinfusionsitesetup,etc.

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

Thepumpcontinuestomonitortheinfusionandmayreducetheratemultipletimes(onlythefirstalarmproducesanaudibletone-ifthefirstalarmissilenced,additionalratereductionswillnotcauseanaudibletonetosound,howevertheamber(yellow)LEDandthealarmmessagewilldisplayandcanbeclearedbypressingí).• Iftheratereductionssucceedin

allowingthebolustobedelivered,thenew,reducedrate(andbolustime)willbecomethesetrateforbolusesinthatinfusion.Inotherwords,whenabolusisContinuedoranotherbolusisinitiatedduringthesameinfusion,oriftheRecall Last Settingsfeatureisused(seepage55),thereducedratewillcontinuetobeapplied.Ifdesired,usetheCHG BoluskeyontheBegin Bolus Delivery?screentoaltertherate(forexample,decreasebolusDoseand/orincreasebolusTime).

2. If,however,thebolusratereducesbelowtheinfusionrate,orthebolustimeincreases

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

CHG BOLUS NO

BEGIN BOLUS DELIVERY?BOLUS 2 MG/KG VOLUME 8 mLTIME 29:50 MM:SS RATE 16.1 mL/Hr

YES


65


pastthemaximumbolustime,thebolusiscancelled.• Pressítosilencethealarm.The

normal infusion delivery is continued.Determinethereasontheboluswasunabletobedeliveredbeforere-attemptingabolus.Oncethereasonfortheboluscancellationiscleared,bolusdeliverymaybere-initiated(ifdesired).Unlessthebolussettingsarereprogrammed(eitherbyenteringtheOptionsmenuandreprogrammingthebolusDoseand/orTime,orbypressingtheCHG BoluskeyattheBegin Bolus Delivery?screenandreprogrammingthebolusDoseand/orTime),thelastbolusratesettingfromjustpriortotheboluscancellationwillcontinuetobeapplied.Reprogramthebolus,ifdesired.


RESTRICTED FLOW - BOLUS CANCELLED

CHG DOSEMAIN MENU

CONC 10 mg/mL PVD 12.763 mLWEIGHT 40 kg

KVO MAX 9 mL/Hr boLUS 2 mg/mLDOSE 4 mg/kg/Hr RATE 16 mL/Hr

CHG BOLUS NO

BEGIN BOLUS DELIVERY?BOLUS 2 MG/KG VOLUME 8 mLTIME 29:54 MM:SS RATE 16.1 mL/Hr

YES


66


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

Set up loading doseIfprogrammingaloadingdoseattheBegin Infusionscreen:

1. Setthedeliverymodeparameters.WhenthepumpispausedattheBegin Infusionscreen,pressOptions.

2. UsethenumberkeystochooseLoading Dose.(YoumayhavetopressMoretoseethisoption.)

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

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

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


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.



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: 10

LOW: 0.0167

CLEAR

MG/KG5DISABLE

5 CURRENT SETTING

NO

CONFIRM TOTAL LOADING DOSE

LOADING DOSE PER KILOGRAM 5 MG/KGWEIGHT 40 KG

YES

TOTAL LOADING DOSE 200 MG

NO

CONFIRM TOTAL LOADING DOSE

YES

TOTAL LOADING DOSE 200 MG

LOADING DOSE PER KILOGRAM 5 MG/KGWEIGHT 40 KG

67


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(page57).




CHG RATEMAIN MENU

CONC 20 mcg/mL PVD 0 mLWEIGHT 40 KG KVO

LOAD 5 MG/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


68


Delivering a loading dose1. Whenready,pressÉ.

2. TheBegin Loading Dosescreenappears.Dependingonwhichmodethepumpisdeliveringin,thescreenisslightlydifferent.

3. Tobegindeliveringtheloadingdose,pressYes.OR

•PressNotoskiptheloadingdoseandreturntothenormaldeliveryscreen.OR

•PressChg Dosetochangetheloadingdosesettings.

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

Note:Ifnokeysarepressedfor30seconds,theUserCallbackalarmwillsound.

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

Thepumpdeliverstheloadingdosethenautomaticallyswitchestothenormaldeliveryrateandscreen.TheloadingdosevolumedeliveredisautomaticallyaddedtotheTotalVolumeDelivered(TVD)aswellastheProgrammedVolumeDelivered(PVD),orProgrammedDoseDelivered(PDD)forthatinfusion.

PRESS CANCEL TO STOP LOADING DOSE DELIVERY DELIVERINGLOAD 5 MG/KG DELIVERED 0.9550 mLREMAINING 02:42 MIN:SS 19.1000 MCGTOTAL LOAD 200 MG RATE 200 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 5 MG/KGTIME 03:00 MM:SS RATE 200 mL/Hr

YES

totaL Loading doSe 200 mg

CHG DOSE NO

BEGIN LOADING DOSE DELIVERY?

YES


LOAD 5 MG/KGTIME 03:00 MM:SS RATE 200 mL/Hr

69


Continuing an interrupted loading doseShouldaHigh Priorityalarmoccurduringloadingdosedelivery,orifáorCancelarepressed,thedosestops.Eithercontinuethedosefromwhereitleftoff,orcancelthedose.


2. PressÉ.3. Tocontinuetheloadingdosefrom

whereitleftoff(deliveringonlywhatwasremaining),pressYes.

PressNotocanceltheremainderoftheloadingdoseandbeginthemaininfusion.

CONTINUE SAME LOAD? BOLUS 5 mg/kg DELIVERED 4.0040 mLREMAINING 05:07 MM:SS 80.0800 MGTOTAL BOLUS 200 MG RATE 70.2 mL/Hr

YES NO

OCCLUSION - CHECK INFUSION LINE aminocaProic acid driP 20 mg/mLLOAD 5 mg/kg DELIVERED 4.0040 mLREMAINING 05:07 MM:SS 80.0800 MGTOTAL LOAD 200 MG RATE 70.2 mL/Hr

CANCEL

70


Loading dose rate reductionTheincreaseddeliveryrateofaloadingdosemaytriggeranocclusionalarm(dependingontheocclusionlimitsettingsinthepumpandtheresistanceintheline).Ifthisoccurs,theloadingtimeisautomaticallyincreasedby30%,thusreducingtheloadingrate.Theloadingratecontinuestobereducedandtheloadingtimeincreaseduntilresistanceisbelowthesetocclusionlimit.Iftheratereductionscannotsucceedindeliveringtheloadingdosewithoutocclusionoccurring(iftheloadingratereducesbelowtheinfusionrate,orthetimeincreasespastthemaximumloadingtime),theloadingdoseiseventuallycancelled.Therecouldbeavarietyofreasonsforocclusionstooccur,including(butnotlimitedto)theocclusionlimitinuse,fluid/medicationviscosity,tubingsize,thepatient’sinfusionsitesetup,etc.

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

Thepumpcontinuestomonitortheinfusionandmayreducetheratemultipletimes(onlythefirstalarmproducesanaudibletone-ifthefirstalarmissilenced,additionalratereductionswillnotcauseanaudibletonetosound,howevertheamber(yellow)LEDandthealarmmessagewilldisplayandcanbeclearedbypressingí).• Iftheratereductionssucceedin

allowingtheloadingdosetobedelivered,thenew,reducedrate(andloadingtime)willbecomethesetratefortheloadingdoseinthatinfusion.Inotherwords,whenaloadingdoseisContinued(ifdeliveryisstoppedforanyreasonwhiletheloadingdoseisbeingdelivered),oriftheRecall Last Settingsfeatureisused(seepage55),thereducedratewillcontinuetobeapplied.Seeitem2onthenextpageforinstructionsonalteringthereducedrate,ifdesired.

RESTRICTED FLOW - RATE REDUCED DELIVERINGLOAD 5 MG/KG DELIVERED 4.8940 mLREMAINING 02:35 MIN:SS 97.8799 MGtotaL Load 200 mg rate 118 mL/Hr

CANCEL

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

71


2. If,however,theloadingdoseratereducesbelowtheinfusionrate,orthedosetimeincreasespastthemaximumloadingdosetime,theloadingdoseiscancelled.Deliverystops.• Pressítosilencethealarm.

Determinethereasontheloadingdosewasunabletobedeliveredbeforere-attemptingaloadingdose.Oncethereasonforthecancellationiscleared,loadingdosedeliverymaybere-initiated(ifdesired).Unlesstheloadingdosesettingsarereprogrammed,thelastloadingdoseratesettingfromjustpriortocancellationwillcontinuetobeapplied.Reprogramtheloadingdose,ifdesired.

•FromtheContinue Same Load?screen,tocontinuedeliveringtheloadingdoseatthenew,reducedrate,pressYes.Toaltertherate,pressNo,pressátostopthenormalinfusion,thenentertheOptionsmenutoreprogramtheLoadingDose(thismethodrestartstheinfusionfromthebeginning,soyoumayneedtomanuallysubtractanyloadingdosedeliveredpriortothecancellationfromtheamountprogrammed).

•IfRecall Last Settingsisused,whenÉispressedtheBegin Loading Dose Delivery?screenappearswiththenew,reducedrate.Ifdesired,usetheCHG Dosekeytoaltertherate(forexample,decreaseloadingDoseand/orincreaseloadingTime).

CONTINUE SAME LOAD? BOLUS 5 mg/kg DELIVERED 4.9690 mLREMAINING 08:28 MM:SS 99.3799 MGTOTAL BOLUS 200 MG RATE 70.2 mL/Hr

YES NO

RESTRICTED FLOW - LOADING CANCELLED aminocaProic acid driP 20 mg/mLLOAD 5 mg/kg DELIVERED 4.9690 mLREMAINING 08:28 MM:SS 99.3799 MGTOTAL LOAD 200 MG RATE 70.2 mL/Hr

CANCEL

CHG DOSE NO

BEGIN LOADING DOSE DELIVERY?LOAD 5 MG/KGTIME 08:33 MM:SS RATE 70.2 mL/Hr

YES


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,whichcanbeaccessedfromtheBegin 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(page57).


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,andthedeliverysitemustremainpatentbetweentheendofoneinfusionandthebeginningofthenext.

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

• TherangeofratesavailableappearsontheEnter KVO Ratescreen.KVOratesarecalculatedbysyringesizeanditsminimumflowrate.

• 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’sorderorthefacility’spoliciesandproceduresforratedetermination.

Enable / Disable KVO Rate:KVO ratecanbeenabledordisabledthroughcustompumpconfiguration(usingPharmGuard®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,orifáispressed.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


StandbyStandbyisanOptionthatallowsthepumptoremainattheBegin InfusionscreenwithouttheUser CallbackalarmsoundingfortheStandbyperiod.

• Thepumpdoes not automatically startaninfusionattheendofthestandby.

• 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(usingPharmGuard®Toolbox2).

Programming standby1. WhenthepumpispausedattheBegin

Infusionscreen,pressOptions.

2. UsethenumberkeystochooseStandby.

3. SettheStandbytimeinhours&minutes.ThemaximumStandbysettingis24hours.ThedefaultStandbytimeis1:00Hr.WhentheStandbytimeiscorrect,pressEntertoacceptthesettingandgototheBegin Infusionscreen.

4. TheStandbytimerthenappearsintheupperrightcorneronscreen“counting down”alternatelywith“Press < « > To Begin Infusion”andtheDrugProgramname.TheUser Callbackalarmisdisabledforthisinterval.Standbycontinuesuntilthetimerhascountedtozero.StandbycanbediscontinuedatanytimebypressingÉ,whenMain MenuispressedtoreturntotheMainmenu,orbysettingStandbytozero.


77


6. Whenthecounterreacheszero,thepumpsoundsanalarmasaremindertobegintheinfusion.


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 Startoptioncanbeenabled/disabledthroughcustomconfiguration(usingPharmGuard®Toolbox2).

79


Periodic callback alarmThePeriodiccallbackalarmisanOptionthatcausesanalarmtobegeneratedataprogrammedperiodoftime.

Note:Duringdeliveryofaloadingdose,bolusdose,orflushdelivery,theperiodiccallbacktimerissuspended,thenrestartsoncetheoptionaldeliveryiscomplete.Forexample,ifaperiodiccallbackissetfor1hour,thenabolusdoseisdeliveredwhichlasts10minutes,theperiodiccallbackwillactuallyoccurat1hourand10minutes.

Programming periodic callback alarm

1. Withthepumpdeliveringaninfusionorpaused,pressOptions.

2. UsethenumberkeystochoosePeriodic Callback Alarm.(YoumayneedtopressMoretoseeit.)

3. Setthecallbackalarmtimeinhours&minutes.Themaximumcallbacktimeis8hours.Thedefaultcallbacktimeis2:00Hr.Whenthecallbacktimeiscorrect,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:ThePeriodic 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),pressingOptionsprovidesaccesstoseveraloverrideandtoggleoptionsthatwillaffectthecurrentinfusiononly.TheseOptionswillreturntothedefaultselectionwheneverthepumpisturnedoff,orwhenevertheprogramisreturnedtotheMainmenupriortobeginningthenextinfusion.


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“continuous”styleinfusion),youmaywanttovieweitherthevolumedelivered(PVD)orthedosedelivered(PDD).ThetogglePVD/PDDoptionmaybeusedattheBegin Infusionscreen,orduringaninfusionwithoutstoppingmedicationdelivery.

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: Whena1mLsyringeisenteredintotheprogramming,theocclusionpressuresettingisfixedatvery high(50psi),meaningthereisnooptionofchangingit.

1. Setthedeliverymodeparameters.WhenthepumpispausedattheBegin Infusionscreen,pressOptions.

2. UsethenumberkeystochooseOverride Occl Limit.(YoumayhavetopressMoretoseethisoption.)

3. Thehighlightshowsthepump’scurrentdefaultsetting.Usethenumberkeystochoosethedesiredocclusionsetting,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,iftheinfusionistakingplaceinanareawithalotofambientroomnoisetheloudestalarmsettingmaybewanted.ThealarmloudnesscanbesetfromLevel1(quietest)toLevel5(loudest),howeveritcannotbedisabledorcompletelysilenced.

1. Withthepumprunningorstopped,pressOptions.

2. UsethenumberkeystochooseOverride Alarm Loudness.(YoumayhavetopressMoretoseethisoption.)

3. Thehighlightshowsthepump’scurrentdefaultsetting.Usethenumberkeystochoosethedesiredalarmloudnesssetting,thenpressEnter.

Todeterminewhichsettingmeetstheneedsfortheinfusion,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™ pressure monitoringThepumphasaninternalprogramforrapidocclusiondetectioncalledFlowSentry™pressuremonitoring.Thepumpmayhavebeenconfiguredtoeitherturnthisfeatureonoroff.Tochangethedefaultsettingforaspecificinfusion,usethisoption.

Note: Withcertainsyringes,suchasthoseforenteraldelivery,FlowSentry™pressuremonitoringisautomaticallydisabledandcannotbeenabled.


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.)Usethisoptiontoenableordisablethisfeatureforthisinfusion.


2. UsethenumberkeystochooseDisable Vol Empty ToneorEnable Vol 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(page57).

Start delivery from pauseWheneverbeginninganinfusionsetupandprogressingallthewaythroughthesetuplevels,thepumppausesattheBegin Infusionscreen.

1. Programaninfusion.2. Verifyallvaluesarecorrect.

3. PressÉ.4. Thepumpbeginstheinfusion.




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


87


Starting delivery from standby or delayed startStarttheinfusionatany timewhenthepumpisonstandbyordelayedstart.Itisunnecessarytoeithercancelstandbyorwaituntilthestandbyperiodends.

1. Tostartinfusionfromstandbyordelayedstart,pressÉ.

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

volumelimitorbolusdose.d) ClearTotals.

Stopping deliveryAninfusioncanbestoppedatany time,inanydeliverymode.

1. Ifthereisanactivealarm,firstsilenceit.Then,pressá.

2. Theinfusingindicatorsturnoffandthepumppauses.Restarttheinfusion,orchangesettingsandrestart.Or,turnthepumpoff.


TIME UNTIL START OF INFUSION 00:59:50

CHG RATEMAIN MENU


NO

CONTINUE SAME INFUSION?

YES


Continuing interrupted deliveryAninfusioncanbecontinuedfromwhereitleftoffshoulditbeinterruptedforanyreason.

1. Ifthereisanactivealarm,firstsilenceit.Then,pressÉ.

2. Tocontinuetheinfusion,pressYes. PressNotocanceltheremainderofthe

infusionandreturntotheMainmenu.

88


Flush featureSomemedicationsandinfusionsmayrequireflushingthelinetoremoveanyresidualmedicationorinfusate.UsingPharmGuard®Toolbox2,thisfeaturecanbeenabledforcertainprofiles,facilitatingthepumptoautomaticallypromptflushingthetubingwhenaninfusioniscomplete.Thepumpmayprompttosetadeliverytimefortheflush,oronlytospecifyavolume(dependingonhowthefeatureis

enabled).Thisfeatureisonlyavailableifenabledforintermittent(timed)infusions(forexample,Dose/kg/Time,Volume/Time,mL/Kg/Time,etc.),andisnotavailableforcontinuousinfusions.Dependingonthepump’scustomconfiguration,avolumelimitmayhavebeensetinthedrugprogramusingPharmGuard®Toolbox2.

Volume only1. Whentheprogrammedinfusionis

completeortheSyringe Emptyalarmactivatesandthepumpalarms,pressí.

2. TheBegin Flush Setupscreenappears.Ifflushisnotdesiredatthispoint,pressNo(thepumpwillreturntotheBegin Infusionscreen).Tobegintheflushsetup,pressYes.

3. Removethesyringeattheendoftheinfusionwhenpromptedandreplacewiththeflushsyringe.Usethenumberkeytoselectthesyringemodel.

4. Loadthesyringeontothepump,verifythecorrectsizeisshown,thenpressEnter.

5. Usethenumberkeystoenterthedesiredamountofflushinginfusate,thenpressEnter.Volumeislimitedbythesizeofthesyringebeingused,andmayalsobelimitedbyanycustomconfigurationsettings.

6. Tobeginflushdelivery,pressConfirm.OR •PressChg VoltoreturntotheFlush

Volumescreenandchangethevolume.OR

•PressMain Menu(orQuick Library)toskiptheflushdeliveryandreturntotheMainmenu.

OPTIONS CLEAR TVD

INFUSION COMPLETE

VOLUME 4 mL TVD 4 mLTIME 00:10:00

TIME REMAINING 00:00:00 RATE 24 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: 0.0333

CLEAR

mL

CHG VOL CONFIRM

CONFIRM FLUSH SETTINGS?

MAIN MENU

VOLUME 1.5 mL Pvd 4 mLTIME 00:03:45 RATE 24 mL/Hr

89


Note:Ifnokeysarepressedfor30seconds,theUser Callbackalarmwillsound.

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

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

8. Whentheflushinfusionhasbeendelivered,deliverystopsandthepumpalarms.Pressítosilencethealarm,thenpressMain Menu.

PRESS < > TO STOP FLUSH DELIVERY

FLUSH VOLUME 1.5 mL FLUSHED 0.140 mLTIME 00:03:45 REMAINING 00:03:22 RATE 24 mL/Hr

FLUSHING

CONTINUE SAME FLUSH?


YES

Pvd 4.151 mL

NO


CANCEL

OCCLUSION - CHECK INFUSION LINE

Continuing an interrupted flush infusionShouldaHigh Priorityalarmoccurduringflushinfusiondelivery,orifáispressedtointerruptaflushinfusion,deliverywillstop.Eithercontinuetheflushfromwhereitleftoff,restartanewflush,orcanceltheflush.


2. PressÉ.

3. Tocontinuetheflushinfusionfromwhereitleftoff(deliveringonlywhatwasremaining),pressYes.

PressNotocanceltheremainderoftheflushinfusionandreturntotheMainmenu.

FLUSH STOPPED - PRESS < « > KEY TO CONTINUE

FLUSH VOLUME 1.5 mL TIME 00:03:45 REMAINING 00:03:22 RATE 24 mL/Hr

YES

Pvd 4.140 mL

NO

INFUSION COMPLETE

VOLUME 1.5 mL TIME 00:03:45 REMAINING 00:00:00 RATE 24 mL/HrMAIN MENU

Pvd 5.5 mL

FLUSH STOPPED - PRESS < « > KEY TO CONTINUE

FLUSH VOLUME 1.5 mL TIME 00:03:45 REMAINING 00:03:21 RATE 24 mL/Hr

YES

Pvd 4.151 mL

NO

90


Volume and time1. Whentheprogrammedinfusionis

completeortheSyringe Emptyalarmactivatesandthepumpalarms,pressí.

2. TheBegin Flush Setupscreenappears.Ifflushisnotdesiredatthispoint,pressNo(thepumpwillreturntotheBegin Infusionscreen).Tobegintheflushsetup,pressYes.

3. Removethesyringeattheendoftheinfusionwhenpromptedandreplacewiththeflushsyringe.Usethenumberkeytoselectthesyringemodel.

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(orQuick Library)toskiptheflushdeliveryandreturntotheMainmenu.

Note:Ifnokeysarepressedfor30seconds,theUser Callbackalarmwillsound.

9. WhenConfirmispressedtheflushinfusionbeginsdelivering,with“Flushing”andthedrugprogramnamealternatelyappearing.

Tocanceltheflush,pressCancel.Ifflushdeliveryiscancelled,orshouldanalarminterruptflushdelivery,itcanberestartedbypressingFlush(oriffinishedpressMain Menu(orQuick Library)toexit).

10.Whentheflushinfusionhasbeendelivered,deliverystopsandthepumpalarms.Pressítosilencethealarm,thenpressMain Menu.

PRESS CANCEL TO STOP FLUSH DELIVERY


CANCEL

FLUSHING

INFUSION COMPLETE

FLUSH VOLUME 1.5 mL FLUSHED 1.50 mLTIME 00:04:30 REMAINING 00:00:00 RATE 20 mL/HrMAIN MENU

FLUSH STOPPED

FLUSH 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?

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

92


Time to occlusionThetimeforthepumptodetectanocclusionisaffectedbythreefactors:1. Occlusion Pressure Setting–High(H),Normal

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

syringeplungertiportubing).Referencepage122fortime-to-occlusionspecifications.Seeguidelinesforpumpperformanceontimetoocclusion.Atlowerratessmallersyringeshaveshorterocclusiontimes,whichiswhythesmallestavailablesyringeforthevolumetobedeliveredshouldalwaysbeused.

Occlusion trend graph during deliveryThepumpautomaticallymonitorsocclusionorsyringebackpressureduringanyinfusion.Thistrendappearsinabar graphontherightsideofthedisplayduringdelivery.Theletteratthetopofthegraphindicatestheconfiguredocclusionalarmlevel:

Code Meaning Relative PressureVH VeryHigh(fixed

for1mLsyringes)50psi(345kPa)

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

Thepressuregraphisscaledbetween0psiatthebottomandtheOcclusionsettingpressureatthetop.TheocclusionlimitcanbesetfromVeryLowtoHighforsyringeswithavolumegreaterthan1mL.Theocclusionlimitisafixedvaluefor1mLsyringes.Thesettingfor1mLsyringesisfixedat50psi,meaningthesettingcannotbechanged.Thereasonforthisisthatatlowerpressuresettingsocclusionalarmswouldbefrequent.Pressuresintheabovetableareonlyapproximations.Thisisbecausesyringefrictionaffectstheactualpressurelevel.OcclusionlimitdefaultissetupusingPharmGuard®Toolbox2,whichwascompletedbythepersonresponsibleforcustomConfigurationbeforethe

pumpsweredeliveredtoaworkarea.OverridethedefaultOcclusionlimitforaparticularinfusionfromtheOptionsmenuifthatoptionisenabled.Thepumptakesthepressuremeasurementapproximatelyeverysecond:• Theright sideofthebaristhemostcurrent

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

PVD 0.55 mL

RATE 10 mL/Hr

LOCK

N

CHG RATE OPTIONS CLEAR TVD

100%B-D 60mL

• Ifthegraphslopesupwardfromlefttoright,thenthepumpmaybeheadedtowardocclusion.

PVD 0.55 mL

RATE 10 mL/HrLOCK

N


100%B-D 60mL

• Ifthegraphislevel,thenbackpressureissteady.

FlowSentry™ pressure monitoring (rapid occlusion detection)FlowSentry™pressuremonitoringisaninternalprogramuniquetoMedfusion®pumpsthatmonitorsandanalyzesdeliverypressure.Whenactivated,FlowSentry™pressuremonitoringalertstotheexistenceofanocclusionmuchmorerapidlythanconventionalocclusionalarmsystems.ThesensitivityoftheFlowSentry™pressuremonitoringsettingisdeterminedbytheselectioninthecustomConfiguration,usingPharmGuard®Toolbox2.How do you know if FlowSentry™ pressure monitoring has been activated?• Duringstartupandduringthestabilization

periodfollowingaratechangeapoundsign(#)willappeartotheleftofthepressuretrendgraph.Thepresenceofthe#indicatesthatFlowSentry™pressuremonitoringisactive,andthatthe

93

Medfusion® Model 3500 pump V6 Operator’s Manualdeliverypressureisstabilizing.

Note: FlowSentry™pressuremonitoringisdisabledatratesgreaterthanroughly⅓ofthesyringesizeperhour.Seethetableatrightformoreinformation.

TVD 1.60 mL PVD 1.60 mL

RATE 10 mL/Hr

LOCK

H


#

60mLB-D

• Oncethedeliverypressurehasreachedastablelevelthe#signwillbereplacedbyahorizontalarrow(≥).


RATE 10 mL/Hr

LOCK

H


B-D 60mL

≥

• Ifthereisanincreaseinthedeliverypressurethehorizontalarrowwillbereplacedbyaverticalarrow(¤).


RATE 10 mL/Hr

LOCK

H


B-D 60mL

¤

Inthiswayitcaneasilybeseenthata)FlowSentry™pressuremonitoringisactivated,andb)whetherthedeliverypressureisstabilizing,steady,orincreasing.IntheeventthattheFlowSentry™pressuremonitoringhasnotbeenactivatedtherewillbeno#orarrowsignstotheleftofthepressuretrendgraph.FlowSentry™pressuremonitoringisautomaticallydisabledwhenthedeliveryrateforasyringesizeisexceededasindicatedinthefollowingtable:

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™pressuremonitoringisdisabled,thebargraphisstillshown,howevernoneoftheicons(#,≥or¤)willappearonscreen.

Post occlusion bolus reduction Withlargesyringes,fluidcanaccumulateorbe“stored”inthelinewhenanocclusionhappens,whichisthendeliveredasaboluswhentheocclusionisreleased.Thisstoredvolumeistheresultofthevolumeofthesyringeandinfusionsetincreasingunderpressure.Thepumpcontainsafeatureforreducingthisbolusuponocclusionrelease(orocclusionbolus).Usingpostocclusionbolusreduction,thepumpwithdrawstheplungerapredeterminedamounttoreduce“stored”bolusinthesyringe.However,thisfeaturedoesnottotallyeliminatetheocclusionbolus.Occlusionboluswillvarygreatlywithocclusionlimitsetting,syringesize,andthefluidinfused.Thepost-occlusionbolusreductionfeaturedecreasesbolusonocclusionreleasetolessthan0.3mL.

WARNING:LargersizesyringesatocclusionsettingHIGHmayproduceapostocclusionboluslargerthan0.3mLduetoexcessivesyringeplungertipcompliance.

94


Making changes during deliveryAtrightisanillustrationofadeliveryscreen.Thereareeightoptionsavailableduringanystandardinfusion.Whilerunninganinfusion,youmay:

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

Changing delivery rateTheMedfusion®Model3500pumpV6offerswaysofchangingdeliveryrateeitherbeforebeginninganinfusion,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 deliveryTheinfusionratecanbechangedduringanydeliverysession,exceptwhenusingIntermittentdeliverymodes.

1. Fromanydeliveryscreen,pressCHG Rate(orCHG Dose).

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

3. Usethenumberkeystosetthedoserate.Rateislimitedbythemaximumandminimumdeliveryrateforsyringesize.

Ifratechangeisnotdesired,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

mL/Hr3.53.5 CURRENT SETTING

BACKSPACE ENTER


HIGH: 944

LOW: 0.1

CLEAR

mL/Hr103.5 CURRENT SETTING

96


Total volume, program volume / dose deliveredTheMedfusion®Model3500pumpV6monitorsandmaintainsthetotalquantityoffluidsbeingdeliveredduringanygivensessionofinfusions.TotalVolumeDelivered(TVD)isdisplayedatthetopofthescreen.TheTVDisthetotalvolumedeliveredtothepatient,accumulatedovermultipledrugprogramsandinfusions,andit will continue to accumulate untilClear TVD (orClear Totals)is pressed or the pump is turned off.TVDcanberecalledusingtheRecallLastSettingsfeature(seepage55).

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

Inmostdeliverymodes,thereistheoptionofviewingeither“Program Volume Delivered”or“Program Dose Delivered”.Onthedisplay,PVDorPDDaccumulatesasthevolumeordoseisdeliveredtothepatient,andaccumulatesfor the current infusion only. PVD/PDDisautomaticallyclearedwhentheinfusionendsandthepumpisreturnedtotheMainmenu,andcanbeclearedbypressingClear Totals.Thisdisplaytotalstheboluses,loadingdose,andnormaldeliveryvolumes.

• Priming volume –Which should never be delivered 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)delivered.(OrpressNotoexitwithoutclearing.)

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

Recovering TVD Information:TheTotalvolumedelivereddisplaycanberestoredafterturningthepumpoffbyusingtheRecall Last SettingsselectionfromtheMainmenu.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.Thelockfeatureisprovidedtomakethedeliverysettingstamperresistant.Oncethekeypadislocked,asettingcannotbemodifieduntilthekeypadisunlocked.TheMedfusion®Model3500pumpV6offersaprogrammableunlockcodeoptionsetthroughcustomconfiguration.Any high-priority alarm automatically unlocks the front panel.

1. PressLocktolockthefrontpanelcontrols.

TheLockindicatoronthefrontpanellights.

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

3. PresstheUnlocksoftkeytounlockthefrontpanel.IfanUnlockPasscodehasbeenset,aprompttosupplythepasscodebeforethefrontpanelwillunlockisdisplayed.

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®Model3500pumpV6hasnumerousalarmsbuiltintoit.Thesearetriggeredbysituationsasameansofwarningoradvisingthatsomethingisnotfunctioningwithinnormalparameters.Pumpalarmsareloggedintothepump’sAlarm History(viewableintheBiomedmenu,andmaybeincludedinvariousreportsviaPharmGuard®Toolbox2).

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-priorityalarmcondition,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 alarmindicatesanyconditionnotrequiringimmediateoperator

intervention.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:Theaudiopartofthelimitpriorityalarmistiedto“KeyClickloudness”,whichissetinPharmGuard®Toolbox2.IfkeyclickloudnessissettoOff,therewillbenoaudibletoneaccompanyinglimitpriorityalarms(visualadvisorymessageswillstillappearinthedisplay).Thevolumewillotherwisesoundattheloudnesslevelselectedforkeyclicks-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,thepumpexpectsyoutocontinueuntilsetupiscomplete.Ifthepumpispausedtoolong(30seconds)afteraprofileisselectedoronadataentryscreen,thepumpinitiatesthisalarm.Thereareseveralbasicresolutions:

Empty”alarmsounds,stoppingtheinfusion.The“Syringe Near Empty”alarmtimemaybesetandisusefulinallowingpreparationtimeforthenextsyringeoncontinuousinfusions.Thisalarmindicatesthetimeremainingtothe“Syringe Volume Near Empty”alarm.The“Syringe Volume Near Empty”alarmprovidesindicationthatthesyringeisnearlyempty.Theremainingtimetothe“Syringe Empty”alarmisvariabledependingonsyringedimensionalvariation.

“Syringe Near Empty” alarmTheSyringe Near EmptyalarmisaMediumorLowpriorityalarmthatoccursindicatingthatthesyringewillreachemptyinthe“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“InfusionComplete,”“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®Model3500pumpV6.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

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

thepumpandthenstartanewinfusion.

“Syringe Volume Near Empty” alarmTheSyringe Volume Near EmptyalarmisaLow priority alarmindicatingthatthesyringehasreachedthesyringe position“VolumeEmpty”.Duetosyringevariationtheremaystillbearesidualvolumeof

102


“Syringe Empty” alarmTheSyringe EmptyalarmisaHighpriorityalarmadvisingthesyringeisempty.TheEmptyalarmstopsdeliveryimmediately.

System Advisory - Maintenance is RecommendedIfyourorganizationhassetupapreventivemaintenancepolicyfortheMedfusion®Model3500pumpV6andprogrammedapreventivemaintenancereminderintheBiomedmenu,aspecialalertisadded.Whenitistimeforapreventivemaintenanceinspection,eachtimethepumpisturnedonSystem Advisory : Maintenance is RecommendedappearsatthetopoftheMainmenu.Pressítosilencetheaudiblealarmandsendpumpformaintenanceassoonaspractical.Thisalertwillrecureachtimethepumpispoweredupuntilatrainedbiomedicalservicetechnicianhasresetit.

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. Iftheinfusioniscompleteeitherturnthe

pumpofforprepareforanotherinfusion.Iftheinfusionisnotcomplete,prepareandloadanothersyringeand:

•returntotheSelect the Profilescreen(wherenoalarmssound)orturnoffthepump.OR

•ifthemodeinusewasacontinuousinfusion,thescreendisplaysContinue Same Infusion?,withchoicesofYesorNo.Continuetheinfusion,orturnthepumpoff.

medicationinthesyringe;thereforetheinfusioncontinues.

1. Pressí.2. Ifyoudo notwishtodeliveranyremaining

fluid,orifthesyringeisempty,pressáandunloadthesyringe.Eitherprepareandloadanothersyringe,returntotheSelect the Profilescreen(wherenoalarmssound),orturnthepumpoff.

3. Thepumpcontinuesdelivery,andcontinuesuntilnofluidremainsinthesyringe.

4. Whenthesyringeplungerreachestheendofthesyringe,ithaltsdeliveryanddisplaysthe“Syringe Empty”messageonscreen.

5. Pressí.(ThepumphasstoppeddeliveryandisattheBegin Infusionscreen.)

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

Monoject® 1, 3, 12 and 35 mL:Becauseofvariationsinsyringemanufacturing,theMonoject®1,3,12and35mLsyringesmayinsomecasesnotfullyempty.Here,theemptyalarmsoundswithsomefluidleftinthesyringe.

103


General system alarms & alertsThissectioncontainsatableofthegeneralsystemalarms,listedalphabetically,whichmaybeencounteredwhileoperatingtheMedfusion®Model3500pumpV6.Thistableidentifiesthealarmbymessageandtype,andprovidesadefinitionandpossibleremedies.

WARNING: Ifasystemfailurealarmoccursandcannotbeclearedbypoweringthepumpdownthenbackup,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,thesyringeinuseisoverfilled(causingthesyringeplungertorepositionitselfoncetheplungerdriverbeginsmovingforward),orthereisaproblemwiththepumphardware.Pressíandchecktheplungerleverandensurethelevermovesfreelyandiscapturingthesyringeplunger.AlwaysusethePrimefeaturewhenloadinganewsyringe.Ifthealarmpersists,removethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

Check Syringe Barrel Clamp

Medium Certainsyringemodelsandsizesmaycausethebarrelclampsensortohavedifficultyinverifyingtheclampisinposition.Whenthisalarmoccurspressí,verifythatthebarrelclampisindeedinplace,thenpressConfirm.OR Whenthepumpwaspoweredup,thesyringebarrelclampwasliftedupandrestingonthepumphandle.Whenthesyringemodelisselected,thisalarmoccurs.Pressí,pressConfirmandcontinueloadingthesyringe.Ensurethatthesyringebarrelclampisproperlypositionedonthesyringebarrel.

Check Syringe Flange Sensor

High Sensorisactivewhenasyringeisnotloadedcorrectly.Checkthesyringeflangeholder.Ensurethesyringebarrelclamp,flangeholder,andplungerholdersareproperlyengagedandtheflangeholderpullsbacktothesideofthecase.Ifholderdoesnotoperatecorrectlyorthealarmpersists,immediatelyremovethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

104


Alarm Message Priority RemedyCheck Syringe Plunger

SensorHigh Sensor is active when syringe is not loaded correctly. Check the syringe

plunger holders. Ensure the syringe barrel clamp, flange holder, and plunger holders are properly engaged and the holders move freely. If they do not operate correctly or if the alarm persists, immediately remove the pump from service for repair by a trained biomedical service technician.

Data Does Not Match Previous Entry

Limit In cases where confirmation of entered data is required, the confirmation value did not match the originally programmed value. Re-enter the correct value.

Enter time as HH:MM (MM:SS) - Use 01:00 for 60

minutes (seconds)

Limit The time value entered is greater than the maximum allowed for the minutes or seconds. Please try a lower value, and use 01:00 for a value greater than 59 minutes when programming hours, and 59 seconds when programming minutes.

Force Sensor Bgnd Test High A background self-test was performed on the force sensor while running an infusion, and the test failed due to a sensor malfunction. Press í. Press É to restart the infusion. If the alarm recurs, remove the pump from service for repair by a trained biomedical service technician.

Infusion Complete High The programmed infusion (based upon the values entered in the pump) has been delivered. Press í. Either begin a new infusion, return to the Select The Profile screen (where no alarms sound), or turn off the pump.

Input Out of Range - Greater Than Max Value

Limit The value entered is greater than the maximum allowed for the item. Please try a lower value.

Input Out of Range - Less Than Min Value

Limit The value entered is less than the minimum allowed for the item. Please try a higher value.

Invalid Entry Limit There is a problem with the drug program selected, and the pump cannot deliver it. Contact your PharmGuard® Toolbox 2 Administrator, who will have to review and correct the problem.

Invalid Infusion Parameter Combination

Low The combination of infusion parameters does not allow a valid flow rate to be calculated. Verify all infusion settings. If the invalid combination is part of a Drug Program, contact your PharmGuard® Toolbox 2 Administrator, who will have to review and correct the problem.

Invalid Syringe Size High Syringe size not recognized for the model selected, or the syringe barrel clamp was lifted during delivery. Review syringe sizes in the technical specifications section, and do not lift the syringe barrel clamp during delivery. If the alarm persists, remove the pump from service for repair by a trained biomedical technician.

KVO in Progress Medium Informational message that volume limit has been reached and KVO infusion is in progress. Press í.

Limits Adjusted - Cannot Deliver All Doses

Limit The PharmGuard® Toolbox 2 specified soft limit values and syringe specified during programming would allow values to be entered that result in a rate outside the allowable limits. The pump has adjusted the limits to keep the rate inside allowable limits. Verify the values entered and the syringe size.

105


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.Clearorremedyanydiscoveredocclusion;forexample,checktheinfusionsetforclosedstopcocks,clamps,checkthetubingforkinks,verifythepatencyofthetubingandtheIVsite,etc.PressÉtorestartinfusiononceocclusionislocatedandcleared.Ifthisalarmoccursfrequentlyandyouhaveruledoutanactualblockage,theinfusionsettubingmaybetoosmallfortherateorfluidviscosity,andyoumaywanttoconsiderenablingFlowSentry™pressuremonitoring,oryoumaywanttoconsiderchoosingadifferentocclusionalarmsettingintheConfiguration.Ifyoucannotcleartheocclusionalarm,theremaybeaproblemwiththepumpthatrequiresrepairbyatrainedbiomedicaltechnician.

Outside Range Limit - Silence Alarm to Continue

Medium TheenteredrateisoutsideoftheDrugProgramsoftlimits.Pressítocontinue.Youmaythenchoosetooverridetherangelimitorchangethevalueentered.

Periodic Callback - Silence Alarm to Continue

Medium Pressí.Userprogrammedcallbackalarm-noremedyrequired.

PharmGuard Data Transfer is Recommended

Medium Assoonaspossible,removepumpfromserviceandtransferPharmGuard®EventDatatoahostcomputer.ContinuedusemayresultinlostPharmGuard®EventData.

Pressure Increasing - Check Infusion Line

Medium Pressí.FlowSentry™pressuremonitoringdetectsincreasingpressureintheinfusionline.Checkinfusionlineforblockage;forexample,checktheinfusionsetforclosedstopcocks,clamps,checkthetubingforkinks,verifythepatencyofthetubingandtheIVsite,etc.Clearorremedyanydiscoveredocclusion.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 Theprogrammedrateisbelowthatrecommendedforthesyringesize-noremedyrequired(seeGuidelines for enhanced pump performance,page22).

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Alarm Message Priority RemedyRestricted Flow - Bolus

CancelledMedium Bolusdeliverywascancelledbeforecompletion.Whilethepump

wasdeliveringabolus,theflowratewasrestrictedandinitiatedratereduction,whicheventuallyfellbelowthemaininfusionrateorextendedpastthemaximumbolustime.Checktheinfusionlineforocclusion.

Restricted Flow - Loading Cancelled

Medium Loadingdosedeliverywascancelledbeforecompletion.Whilethepumpwasdeliveringaloadingdose,theflowratewasrestrictedandinitiatedratereduction,whicheventuallyfellbelowthemaininfusionrateorextendedpastthemaximumloadingdosetime.Checktheinfusionlineforocclusion.

Restricted Flow - Rate Reduced

Medium Ifthebolusorloadingdoserateishighenoughtotriggeranocclusionalarm,thesoftwarereducestherateuntilthebolus/loadingdoseissuccessfullydeliveredor,iftheratefallsbelowacertainlevelortakeslongerthanthepumpallows,iscancelled.Witheachratereduction,thisprocessrepeats.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. •Turnthepumpoff.

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

sound. •Turnthepumpoff.

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(thedefaultpriorityisLow).Thealarmtonemaybeenabled/disabledintheOptionsmenuiftheOptionismadeavailableintheProfile;thedefaultisenabled.

107


Alarm Message Priority RemedySyringe Plunger Not in

PlaceHigh Pressí.Thesyringeisnotloadedcorrectly,orthesensorhasfailed.

Makesurethesyringeplungerheadisproperlyinserted.Proceedwiththeinfusion,ifpossible.Ifthealarmrecurs,removethepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

Syringe Volume Near Empty

Low Pressí.Thepumphascalculatedthatthevolumeofmedicationinthesyringeisnearlyempty.The“SyringeEmpty”Alarmwillactivatewhenthesyringeisempty.Makepreparationstoinstallanewsyringe,ifnecessary.Thetimeuntilthesyringeisemptycanbeestimatedbyestimatingthevolumeremaininginthesyringeanddividingbythedeliveryrate.Thealarmtonemaybeenabled/disablediftheOptionismadeavailableintheProfile;defaultistonedisabled(silent).

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

sound. •Turnoffthepump.

*“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 Charging

Low Theinternalbatteryisnotcharging.ThepumpmaybeusedonACpoweronaconditionalbasis.Assoonaspossible,removepumpfromserviceforrepairbyatrainedbiomedicalservicetechnician.

System Advisory :

Battery Not Working

Medium Theinternalbatteryisnotworking.ThepumpmaybeusedonACpoweronaconditionalbasis.Assoonaspossible,removepumpfromserviceforrepairbyatrainedbiomedicaltechnician.

System Failure :

Depleted Battery

SystemFault

Pressëtoturnthepumpoff.Thebatteryiscompletelydrained.PlugintheACpowercord,thenpressëtoturnthepumpon.Untilthebatteryisallowedtorecharge,thepumpcanonlybeusedifconnectedtoACpower.

System Advisory :

Low Battery

MediumorLow

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

108


System Failure Alarms

Alarm Message Priority RemedySystem Failure :

Control Key Switch BGND Test

System Fault

Either a key on the keypad has been pressed for longer than 7 seconds, or the keypad needs to be replaced; fluid delivery stops. Press ë to turn the pump off, then turn it back on. If the alarm persists when the pump is turned back on, immediately remove pump from service for repair by a trained biomedical technician.

System Failure:

Configuration Required

System Fault

The pump has detected that a Configuration is not loaded onto the pump, and the pump cannot be used. A Configuration must be loaded onto the pump either using PharmGuard® Toolbox 2 or the Configuration Cloning procedure. Remove the pump from service and replace with another pump which has a validated Configuration.

System Failure:

Force Sensor Test

System Fault

A self-test was performed on the force sensor, and the test failed due to a sensor malfunction OR the Syringe Plunger Driver was being moved during the pump startup process, or the Syringe Plunger Driver received a hard bump during the pump startup process. Press í. Press ë to turn the pump off, then turn the pump back on. If alarm persists, remove the pump from service for repair by a trained biomedical service technician.

System Failure:

Supercap Post

System Fault

Power-up self-test sensed insufficient charge in the super-capacitor. This problem can occur when a new Main PCB is installed or when a pump battery is totally dead. Plug the pump into AC power for at least two minutes then turn the pump off, then back on. If the alarm persists when the pump is turned back on, immediately remove pump from service for repair by a trained biomedical technician.

System Failure :

xx xx xx

System Fault

Where “xx xx xx” indicates additional text for the specific type of failure. The pump display shows the Main menu, with only the Biomed menu available. Some system failures result in a hardware “watchdog” alarm which results in an alarm tone sounding (and may or may not be accompanied by a flashing red alarm indicator). Press ë to turn off pump, then back on. If the alarm persists when the pump is turned back on, immediately remove pump from service for repair by a trained biomedical technician.

System Advisory AlarmsAlarm Message Priority Remedy

System Advisory : Improper Shutdown

Low The pump improperly powered down. As soon as possible remove pump from service for repair by a trained biomedical technician.

System Advisory :

Maintenance is Recommended

Low The scheduled Preventive Maintenance is due. As soon as possible, remove pump from service for testing and checkout by a trained biomedical technician. This alarm will reactivate each time the pump is powered on until service is performed.

System Advisory :

Set Time and Date

Low The pump’s Time and Date settings have been lost. As soon as possible, remove pump from service for testing and checkout by a trained biomedical technician.

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Alarm Message Priority RemedySystem Advisory :

xx Data Corrupted

Low Infusionwillcontinueusingbackupcopyofxx data(wherexxrepresentsvariabletextindicatingthespecificdatathatiscorrupted).Assoonaspossible,removepumpfromservicefortestingandcheckoutbyatrainedbiomedicalservicetechnician.

110


Battery and AC power operationTheinfusionpumpistypicallyoperatedbyAC(mains)power.Thepumpcontainsarechargeablebatterythatiscontinuallycharged–aslongasthepumpisconnectedtoACpower(seepage122forbatterylifespecification).IftheACisdisconnectedwhilethepumpisturnedon,thepumpautomaticallybeginsdrawingpowerfromtheinternalbattery.

Attaching the power cord:1. ConnecttheACpowercordtothe

connectorportonthepump.

2. Dropcordclipoverthetopoftheconnector(topreventaccidentallyunpluggingpump).

WARNING: Shock Hazard.TheonlymeansofremovingACpoweristodisconnecttheACpowercord.WhiletheACpowercordisattachedtothepumpandpluggedintoanACoutlet,livemainsvoltageispresentinsidethepump.

111


On screen display of internal battery power level gaugeWheneverthepumpisturnedon,theinternalbatterychargelevelbrieflyappearsonthe“battery shaped”gaugeinthebottomleftcornerofthedisplay.

VERIFYING CONFIGURATION

PHARMGUARD® MEDICATION SAFETYHOSPITAL VERSION V6.0.0 M001234CONFIG VERSION: 01.05.00002 CONFIG CRC: 4A4F

5 SECONDS REMAINING © 99-2013100%

Whenrunninganinfusiononinternalbattery,this“battery shaped”gaugealsoappearsbrieflyintheupperrightcornerofthedisplayatthestartofdelivery.

Pvd 0.18 mL

rate 5 mL/Hr

LOCK

N

CHG RATE CLEAR TVD

100%B-D 60mL

Brieflydisplaythis“battery shaped”gaugeatanytimewhilethepumpisinfusingonbatterybypressingâ.

Battery guidelines Power & Battery Limits

When to charge the battery

When the “Battery Low”message displays, plug thepump into a power outlet forrecharging.Thebatteryindicatorremains on continuously whencharging.IfthepumpISpluggedintoanoutletandfailstochargethebattery,orthepumphasbeenstoredforlongerthantwomonthswithoutcharging,contactService&Repairforinformationonhowtotestand/orservicethebattery.

When you can run on battery

The internal battery is intendedtoallowinfusionsofmedicationsand fluids when an externalpoweroutlet isnot convenientlyavailable or when the patient isbeingmoved.

When you cannot run on battery

When the battery becomes fullydepleted, all infusion stops, anda “Battery Depleted” alarmbegins sounding. For a fullydepletedbattery, plug in theACpowercord,turnthepumpofftoclearthealarm,andthenturnthepump back on. Leave the pumppluggedinforatleast16hourstocompletelyrechargethebattery.

• See “General System Alarms and Alerts” table to identify battery message status.

112


Poleclamp use Thissectioncontainstheinstructionsforusingthepoleclampoptionsavailableforthepump.

ThepoleclampanchorisattachedtothepumpaccordingtotheInstructions for Usesuppliedwiththepoleclampassembly.

CAUTION:Thispumpisdesignedtobeusedinahorizontalposition.Ifthepumpisoperatedinanyotherposition(includingvertical),thereisanincreasedpotentialforfluidleakingintothepump.Ifyoususpectfluidhasleakedintoapump,removeitfromserviceuntilatrainedbiomedicaltechniciancantestit.

Rotating/detachable poleclamp (standard)SmithsMedicalofferstworotatingpoleclamps,onewitha90-degreeangleanchorbracket(catalognumber22-1050-51),andonewitha100-degreeangleanchorbracket(catalognumber22-1051-51)(olderpumpsmayusepoleclampcatalognumber3000RPC,whichisnolongeravailable).The100-degreeanchorbracketattachesthepumptoapoleataslightforwardangle,makingthedisplayandkeypadeasiertoviewwhenpumpsareattachedtoapoleincertaincircumstances(forinstance,highonapole).Alignthepoleclampformountingonanyverticalorhorizontalpole,bedrail,orsimilarsolidstructuresmallenoughtofitwithintheclamp’sjaws.Thelightweightofthepumpmakesthisconvenient.

1. Opentheclampjawswideenoughtoeasilysliparoundthepole.

2. Tightentheclampuntil it is securely fastenedsothepumpcannotbemoved.

CAUTION:Alwaysverifythestabilityoftheobjecttowhichthepumpismounted(forinstance,anIVpole)beforeusingthepoleclamp.Failuretoverifythestabilitycouldcausetheobjecttotip,withthepossibilityofcausingdamagetothepumpandotherequipment.Ifthepoleclampisnotadequatelytightened,itcouldcausethepumptofall.

90-degree poleclamp

100-degree poleclamp

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Assembling the rotating/detachable poleclamp

1. Ifnecessary,slidetherotatingpoleclampontothepoleclampanchorattherearofthepumpuntiltheretainerlockbuttonaudiblyclicksintoplace.

2. Pulltheroundlockbuttonatthetopoftheclampassemblyupandrotatetheclamptothedesiredangle.Thepoleclampcanberotatedsothepumpishorizontal,vertical,orata45°angletoeithersideofvertical.

3. Toremovethepoleclampfromthepump,pullthereleaselevertowardthepumpandslidethepoleclampoffthepump.

114


EMC information for the Medfusion® Model 3500 pump V6

ElectromagneticCompliance(EMC)precautionsarenecessarywhendealingwiththeMedfusion®Model3500pumpV6.AccessiblepinsofconnectorsidentifiedwiththeESDwarningsymbolnearthemshouldnotbetouchedwiththefingersorhand-heldtool,unlessproperprecautionarymeasuresarefollowed.Thesemeasuresinclude:1) Dischargingone’sbodytoearthortoalargemetal

object.2) BondingoneselfbymeansofanESDwriststrap

toearth.Itisrecommendedthatallstaff,includingclinicalandbiomedicalstaff,receivetraininginthemeaningoftheESDwarningsymbol,andontheaboveprecautionarymeasures.Thistrainingshouldalsoincludeanintroductiontothephysicsofelectrostaticdischarge,thevoltagelevelsthatcanoccurinnormalpractice,andthedamagethatcanbedonetoelectroniccomponentsiftheyaretouchedbyanoperatorwhoiselectrostaticallycharged.Further,anexplanationshouldbegivenofthemethodstopreventbuild-upofelectrostaticcharge,andhowandwhytodischargeone’sbodytoearth,ortobondoneselfbymeansofawriststraptoearthpriortomakingaconnection.

Use of cables

WARNINGS: • Useofcablesotherthanaslistedbelowmay

resultinincreasedEMCemissionsordecreasedimmunityofthepump.

• UseofthelistedcableswithequipmentotherthanthosespecifiedmayresultinincreasedEMCemissionsordecreasedimmunityoftheequipmentorsystem.

• Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.

ThispumphasbeentestedforEMCwiththefollowingcable:

• SmithsMedicalG6000329ACpowercord(USA)

Stacked equipment

WARNING:Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.

MedicalElectricalEquipmentneedsspecialprecautionsregardingEMCandneedstobeinstalledandputintoserviceaccordingtotheEMCinformationprovidedinthismanual.PortableandmobileRFcommunicationequipmentcanaffectMedicalElectricalEquipment.

115


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

standard:ProgrammableelectricalmedicalsystemsIEC60601-1-6(2006) Medicalelectricalequipment–Part1-6:Generalrequirementsforsafety–collateral

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

pumpsandcontrollersIEC62304(2006) Medicaldevicesoftware-SoftwarelifecycleprocessesIEC62366(2007) MedicalDevices,ApplicationofusabilityengineeringtomedicaldevicesEN475(1995) MedicalDevices-Electrically-generatedalarmsignalsUL60601-1(2006) MedicalElectricalEquipment,Part1:GeneralRequirementsforSafety(US

DeviationstoIEC60601-1)CAN/CSA-C22.2No.601.1-M90(1990)

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) TitleIEC60601-1-2(2007) Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateral

standard:Electromagneticcompatibility-Requirementsandtests.Amendment1(2004)(AppliestoallsectionsexceptIEC/EN61000-4-2,ElectrostaticDischargeImmunitytest)

IEC60601-1-2(1993) Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-Requirementsandtests(AppliestosectionIEC/EN61000-4-2,ElectrostaticDischargeImmunitytest)

EN60601-1-2(2007) Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-Requirementsandtests.(AppliestoallsectionsexceptIEC/EN61000-4-2,ElectrostaticDischargeImmunitytest)

EN60601-1-2(1993) Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-Requirementsandtests(AppliestosectionIEC/EN61000-4-2,ElectrostaticDischargeImmunitytest)

116


Reference (Year) TitleIEC/EN61000-4-2 ElectromagneticCompatibility(EMC),Part4:Testingandmeasurement

techniques.Section2:ElectrostaticDischargeimmunitytest.BasicEMCPublicationIEC/EN61000-4-3 ElectromagneticCompatibility(EMC),Part4:Testingandmeasurement

techniques.Section3:Radiated,radiofrequency,electromagneticfieldsimmunitytest.BasicEMCPublication

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

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

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

IEC/EN61000-4-8 ElectromagneticCompatibility(EMC),Part4:Testingandmeasurementtechniques,Section8:Powerfrequencymagneticfieldimmunitytest.Amendment.

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

EN55011(2009) Industrial,scientificandmedical(ISM)radiofrequencyequipment-Radiodisturbancecharacteristics-Limitsandmethodsofmeasurement.Amendment1(2010)

AS/NZS3200.1.2(2005) Australian/NewZealandStandard,Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-RequirementsandtestsParentStandard(AppliestoallsectionsexceptIEC/EN61000-4-2,ElectrostaticDischargeImmunitytest)

AS/NZS3200.1.2(1995) Australian/NewZealandStandard,Medicalelectricalequipment-Part1.2:Generalrequirementsforsafety-Collateralstandard:Electromagneticcompatibility-RequirementsandtestsParentStandard(AppliestosectionIEC/EN61000-4-2,ElectrostaticDischargeImmunitytest)

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

ASTMF2052-02 StandardTestMethodforMeasurementofMagneticallyInducedDisplacementForceonMedicalDevicesintheMagneticResonanceEnvironment

Miscellaneous StandardsReference (Year) TitleIEC60320-1(2001) Appliancecouplersforhouseholdandsimilargeneralpurposes-Part1:General

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

IEC60529(2001) DegreesofProtectionProvidedbyEnclosures(IPCode)IEC60878(2003) GraphicalSymbolsforelectricalequipmentinmedicalpracticeEN980(2008) GraphicalSymbolsforUseintheLabelingofMedicalDevices

117


Reference (Year) TitleEN1041(2008) InformationSuppliedbytheManufacturerwithMedicalDevicesENISO10993-1(2003) BiologicalEvaluationofMedicalDevicesPart1:EvaluationandTestingASTMF2503-08 StandardPracticeforMarkingMedicaldevicesandOtherItemsforSafetyinthe

MagneticResonanceEnvironmentISO3744(1994) Acoustics-DeterminationofSoundPowerLevelsENISO14971(2007) MedicalDevices,ApplicationofRiskManagementtoMedicalDevicesUL746C(2004) PolymericMaterials-UseinElectricalEquipmentEvaluations

118


Guidance and Manufacturer’s Declaration – Electromagnetic EmissionsTheMedfusion®SyringePumpModel3500V6isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheMedfusion®SyringePumpModel3500V6shouldassurethatitisusedinsuchanenvironment.

Emissions test Compliance Electromagnetic environment - guidanceRFEmissions

CISPR11

Group1 TheMedfusion®SyringePumpModel3500V6usesRFenergyonlyforitsinternalfunction.Therefore,itsRFemissionsareverylowandarenotlikelytocauseanyinterferenceinnearbyelectronicequipmentRFemissions.

RFemissionsCISPR11

ClassA TheMedfusion®SyringePumpModel3500V6issuitableforuseinallestablishmentsotherthandomesticandthosedirectlyconnectedtothepubliclow-voltagepowersupplynetworkthatsuppliesbuildingsusedfordomesticpurposes.

Harmonicemissions

IEC61000-3-2

NotApplicable

Voltagefluctuations/Flickeremissions

IEC61000-3-3

NotApplicable

Compliance using:1. ACpowercordlengthof2.4m(8feet).2. RechargeableNiMHbatterypack.

WARNING:Thepumpshouldnotbeusedadjacenttoorstackedwithotherequipment.Ifadjacentorstackeduseisnecessary,theusershouldverifynormaloperationofthepumpintheconfigurationinwhichitistobeused.

119


Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityTheMedfusion®SyringePumpModel3500V6isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheMedfusion®SyringePumpModel3500V6shouldassurethatitisusedinsuchanenvironment.

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

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Surge

IEC61000-4-5

±1kVdifferentialmode

±2kVcommonmode

±1kVdifferentialmode

±2kVcommonmode

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.

Voltagedips,shortinterruptionsandvoltagevariationsonpowersupplyinputlines

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

Mainspowerqualityshouldbethatofatypicalcommercialorhospitalenvironment.IftheuseroftheMedfusion®SyringePumpModel3500V6requirescontinuedoperationduringpowermainsinterruptions,itisrecommendedthattheMedfusion®SyringePumpModel3500V6bepoweredfromanuninterruptiblepowersupplyorabattery.

Powerfrequency(50/60Hz)Magneticfield

IEC61000-4-8

3A/m 400A/mand3A/m

Powerfrequencymagneticfieldsshouldbeatlevelscharacteristicofatypicallocationinatypicalcommercialorhospitalenvironment.

Note:UtistheACmainsvoltagepriortoapplicationofthetestlevel.

120


Guidance and manufacturer’s declaration – electromagnetic immunityTheMedfusion®SyringePumpModel3500V6isintendedforuseintheelectromagneticenvironmentspecifiedbelow.ThecustomerortheuseroftheMedfusion®SyringePumpModel3500V6shouldassurethatitisusedinsuchanenvironment.

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

3V

10V

10V/m

Portable and mobile RF communicationsequipment should be used no closer toany part of the Medfusion® Syringe PumpModel 3500 V6, including cables, than therecommended separation distance calculatedfromtheequationapplicabletothefrequencyofthetransmitter.Recommended separation distanced = 1.2

d = 1.2

d = 1.2 80MHzto800MHz

d = 2.3 800MHzto2.5GHzwherePisthemaximumoutputpowerratingof the transmitter inwatts (W) according tothe transmitter manufacturer and d is therecommended separation distance in metres(m).b

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

Interference may occur in the vicinity ofequipmentmarkedwiththefollowingsymbol:

îNOTE1 At80MHzand800MHz,thehigherfrequencyrangeapplies.NOTE2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,objectsandpeople.aTheISM(industrial,scientificandmedical)bandsbetween150kHzand80MHzare6.765MHzto6.795MHz;13.553MHzto13.567MHz;26.957MHzto27.283MHz;and40.66to40.70MHz.bThecompliancelevelsintheISMfrequencybandsbetween150kHzand80MHzandinthefrequencyrange80MHzto2.5GHzareintendedtodecreasethelikelihoodthatmobile/portablecommunicationsequipmentcouldcauseinterferenceifitisinadvertentlybroughtintopatientareas.Forthisreason,anadditionalfactorof10/3isusedincalculatingtherecommendedseparationdistancefortransmittersinthesefrequencyranges.cFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheMedfusion®SyringePumpModel3500V6isusedexceedstheapplicableRFcompliancelevelabove,theMedfusion®SyringeInfusionPumpModel3500shouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingtheMedfusion®SyringePumpModel3500V6.dOverthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

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Recommended separation distances between portable and mobile RF communications equipment and the Medfusion® Syringe Infusion Pump Model 3500 V6

TheMedfusion®SyringePumpModel3500V6isintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesarecontrolled.ThecustomerortheuseroftheMedfusion®SyringePumpModel3500V6canhelppreventelectromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment(transmitters)andtheMedfusion®Model3500pumpV6asrecommendedbelow,accordingtothemaximumoutputpowerofthecommunicationsequipment.

RatedMaximumoutputpoweror

transmitterW

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

d = 1.17

150kHzto80MHzinISMbands

d = 1.2

80MHzto800MHz

d = 1.2

800MHzto2.5GHz

d = 2.3

0.01 .12 .035 .035 .230.1 .37 .38 .38 .731 1.2 1.2 1.2 2.310 3.7 3.8 3.8 7.3100 12 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.

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Technical specificationsSpecificationsBelowarethetechnicalspecificationsoftheMedfusion®Model3500pumpV6.Testingwasperformedusingthesyringeslistedinthetableonpage128andthefollowingMedfusion®AdministrationSets:1)Model536040forlowflowratesand2)ModelMX448HL60forhighflowrates.

Minimum increment of resolution

0.01mL/hr

Size (pump only) 27cmwide×13cmhigh×14cmdeep(10.5”×5.1”×5.5”)Weight Approximately1.7kg(3.8lbs.)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 VeryHigh(50psi)testingperformedusingB-D®1mLsyringe;HighandVeryLowtestingperformedusingB-D®20mLsyringe(syringesmeettherequirementsoftheISO7886-2standard).Flow Rate (mL/hr) Syringe (Mfg / Size) Occlusion Setting Max time to

occlusion (Start-up) hr:min:sec

1(minimum) B-D®1mL VeryHigh(50psi) 00:10:00B-D®20mL High(16psi) 00:31:00

VeryLow(4psi) 00:09:005(intermediate) B-D®1mL VeryHigh(50psi) 00:01:00

B-D®20mL High(16psi) 00:06:00VeryLow(4psi) 00:05:00

Power source Internal battery: Rechargeable(nickelmetalhydride)AC power: 100-240VAC,50/60Hz,30VA;SafetyClassIIDC Power Supply (optional)

ExternalDCInput6–14VDC,7WattsSafetyClassII–TypeCF(mustmeetIEC60601-1MedicalEquipmentStandards)

Battery Life 500fulldischarge/chargecyclesor2years,whichevercomesfirstBattery longevity At25°C(77°F),afullychargedbatterywillrunthepumpforatleast6hourswhen

runningacontinuousrateof5mL/hrandusinga60mLsyringe.

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Operating conditions Temperature: 5°to40°C(41°to104°F)Relative Humidity: 20%to95%non-condensingAmbient Pressure: 70kPato106kPa(10.2psiato15.4psia)

Storage/transportation conditions

Temperature: -20°to50°C(-4°to122°F)Relative Humidity: 20%to95%non-condensingAmbient Pressure: 70kPato106kPa(10.2psiato15.4psia)NOTE:Thepumpmaynotmeetperformancespecificationswhenstored,transportedorusedoutsidetherangesgivenaboveforstorage/transportandoperatingconditions.

Infusion Back Pressure -100mmHgto300mmHgDelivery Accuracy Nominal±2%(±syringeaccuracy)(forinfusionbackpressuresof-100mmHg

to+300mmHg).Atlowinfusionrates,thesystemaccuracymaynotbeachievedforshortperiods.Duringthetotalinfusiontime,theaccuracyaveragesout(seeaccuracycurves,page136).Overallflowrateaccuracyisequaltopumpaccuracycombinedwithsyringetolerances.ForsyringesspecifiedtomeettheISO7886-2standard,syringeaccuracymaybeexpectedtomeetthe±2%requirement.

WARNING:Ensurethatthe±2%accuracyspecificationistakenintoaccountwhenprogrammingthepumpand/orfillingasyringe.Ifaccuracyisofprimeconcern,useonlysyringesthatmeetthe±2%requirementoftheISO7886-2Standard.Failuretodosomayresult inmedicationinthesyringebecomingdepletedsoonerthanexpected.Ifthepumpisbeingusedtodelivercriticalorlifesustainingmedication,theinterruptioninthedeliveryofmedicationcouldresultinpatientinjuryordeath.

Bolus Accuracy ThisdatagatheredusingaBD®20mLsyringeMinimum Bolus* Minimum

Recommended BolusMaximum Bolus

Average(mL) 0.030 0.988 19.830%AverageError -11.09 -1.23 -0.85MaximumPos.Error%

14.12 0.32 -0.38

MaximumNeg.Error%

-44.71 -3.52** -1.369

MinimumDeviation(mL)

-0.004 0.003 -0.075

MaximumDeviation(mL)

-0.015 -0.035 -0.272

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

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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(seepage133forfurtherexplanation)

Maximum delivery rate during Prime

Theprimingdeliveryrateis300mL/hrorthedefaultmaximumbolusrateforthesyringesizebeingused(Syringesize×5mL/hr,Syringesize×10mL/hrorSyringesizeMaxmL/hr),whicheverislower(seepage133,MaximumBolusRate,forfurtherexplanation)

Infusion rate range: 0.01mL/hrto1130mL/hrinincrementsof0.01/0.1mL/hr(dependingonsyringesize/rate).Refertosyringetablesonpage129forMinimumRecommendedRate.

Bolus volume range: Volumeislimitedtothemaximumfillvolumeofthecurrentsyringesize,andminimumvolumeis1/600ththesyringesize

Note:TheMinimumRecommendedBolusVolumeis10%ofsyringeor1mL,whicheverissmaller.Bolusvolumesdeliveredthatarelessthantherecommendedminimumbolusvolumeforthesyringeusedmayresultindeliveryinaccuracies.

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

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User-defined libraries StandardlibrariesareorganizedonaperProfilebasis.EachProfileallowsuptoeightlibraryCategorieswithupto36DrugProgramseach,forapossibletotalof288entriesperprofileOne“QuickLibrary”perProfileforrapidsetup

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

RotatingPoleclamp(catalognumbers:100-degree-22-1051-51;90-degree-22-1050-51)PharmGuard®Toolbox2,Version3orhigherMedfusion®StandardConfiguration(catalognumber67-2460-[currentversion])Medfusion®StandardSyringes(catalognumber67-2459-[currentversion])LockboxwithKeys(22-1000-51)Infrared-RS232ConverterBox(3000RS232)CloningBlock(G6000200)PharmGuard®SupportedSyringes(PSS)Series2(various,contactSmithsMedicalfordetails)Forreplacementparts,includingpowercordsandreplacementbatterypacks,seetheMedfusion® Model 3000 Series Technical Service Manual(catalognumberG6000278)

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Medfusion® Model 3500 pump V6 Operator’s Manual(MotorDrivePhaseA/BPOST,theabilityforthewatchdogtostopthemotor(MotorDriveoffPOST).Periodicallyduringpumpoperationsthesoftwarechecksmotoroperationinbackground.Motorbackgroundchecksincludethestoppingofthemotorwhenaninfusionstopsandthemotorsupplyvoltagetest.IfamotorPOSTorbackgroundcheckfailsthepumpwilldisplayasystemfaultscreen,turnonacontinuoustwo-toneaudiblealarm,flashthebacklightandstopalldrugdelivery.IftheMotorshaftfailstocompletethefirstshaftrotation(MotorNotRunning)orasubsequentshaftrotation(MotorRateError)withtheexpectedtimingthepumpwilldisplayahighpriorityalarm,turnonacontinuoustwo-toneaudiblealarm,flashthebacklightandstopalldrugdelivery.WhenthepumpispoweredonwithadepletedbatteryandnoACpower,thisalarmmaysoundduetothelowbatterystate.Rechargethebattery,turnthepumpon,turnthepumpoff,thenturnthepumpontoclearthecondition.

Keyboard Encoder Check - Control key POST or

BGND Everytimethesoftwarereceivesdatafromthekeyboardencoder,itischecked.Ifthedataisnotavalidkeypress,thesoftwarewilldisregardthekeypress.

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

Data Used in Calculations - Critical data failureCalculationsondatausedinsomewaytocontrolthe

Safety FeaturesSafety Features and Fault DetectionHardware Safety FeaturesAwatchdogcircuit,madeupofaseparatemicrocontrollerwithadedicatedtimer,alarmspeaker,andpowersupply,monitorsthemainmicroprocessorandassociatedelectronics.Thepurposeofthiscircuitistodetectfailuresofthesystemincludingpower,electronicsandsoftware,andgenerateanalarmifoneisdetected.Ifafailureisdetected,awatchdogor“SYSTEMFAILURE”alarmwillbegeneratedthroughthededicatedspeaker,theredalarmindicatorwillbeturnedon,andthepumpingmechanismwillbedisabled.Somewatchdogfailures(forexample,onethatmayoccurrarelywhenpoweringdownfollowingaConfigurationupdate)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.MotorPOSTchecksincludetheabilitytodrivecurrenttothemotor

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Medfusion® Model 3500 pump V6 Operator’s Manualdeliveryofdrugareperformedredundantly.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.

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Additional Technical InformationMedfusion® Standard SyringesBelowisatableofthestandardmodelsyringessuppliedwithPharmGuard®Toolbox2(andincludedintheMedfusion®StandardConfiguration)whichcanbeusedwiththeMedfusion®Model3500pumpV6.(Informationregardingsyringeflowrateandminimumvolumeforthesesyringescanbefoundonthenextpageandintheproductliteraturesuppliedwiththesyringefile.)

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

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

Monoject® (Covidien) 3,6,12,20,35and60mL(Luerlock)1mLSliptip(Tuberculin)

Terumo® (Terumo® Medical)

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

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

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

Thecriticalvolume(maximum)whichcouldbeinfusedintheeventofasinglepointfailureis1/100thofthesyringesizebyvolume.

PharmGuard® Supported Syringes (PSS) Series 2Inordertooffercustomersawiderangeofavailablesyringemanufacturersandsizes,SmithsMedicalhasavailablePharmGuard®SupportedSyringes(PSS)Series2inadditiontotheMedfusion®StandardSyringes.Refertowww.smiths-medical.comorcallCustomerServiceformoreinformationaboutavailablePharmGuard®SupportedSyringes(PSS)Series2.ThePharmGuard®SupportedSyringes(PSS)Series2canonlybeimportedintothePharmGuard®Toolbox2.TheseadditionalsyringemodelscanbesenttoapumpasavailablesyringesforthedownloadableConfigurations.(InformationregardingsyringeflowrateandminimumvolumeforthesesyringescanbefoundintheproductliteraturesuppliedwiththePSSSeries2.)

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Flow rate & minimum volume by manufacturer & size - Standard syringesForflowrateandminimumvolumeinformationregardingsyringesavailableinthePharmGuard®SupportedSyringes(PSS)Series2,seetheproductliteratureprovidedwiththatproduct.Pleaseseethetablesbelowforinformationregardingthelowestrecommendedratesforeachsyringesizeusedonthepump.Thetablebelowisprovidedforconvenience.Shouldchangestothelistedsyringesoccur,thevaluesshownheremaybesuperseded(seetheInstructions for UseprovidedwiththeMedfusion®StandardSyringes,Series2.)

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 (Slip Tip) 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 (Slip Tip) 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 (Slip Tip) 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*

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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™pressuremonitoringisnotavailablewith1mLandTerumo®syringes.

Syringe Size Minimum Recommended Bolus Volume

1mL 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:Deliveringabolusvolumelessthantherecommendedbolusvolumeforthesyringeusedmayresultindeliveryinaccuracies.Useaninfusionsetwiththesmallestdiametertubingavailablethatdoesnotresultinexcessivebackpressureatthedesiredflowrate.Considerpriming,loading,bolus,andflushrateswhenselectinganinfusionset.

PertheUSFoodandDrugAdministration,the28syringesavailableasthegeneralconfigurationfortheMedfusion®Model3500pumpV6weretested

forstabilitywithMorphineSulfate,DopamineandFloxuridineforInjection,USPasmedicationsrepresentativeofdrugsusedfortheroutesofadministrationspecifiedforusewiththeMedfusion®Model3500pumpV6.Thetestingdemonstratedthatthepumphadnoadverseaffectonthesyringesandthemedicationscontainedwithin.OthermedicationsmaybesuitableforusewiththesyringesreferencedforusewiththeMedfusion®Model3500pumpV6.Beforeusingdifferentmedications,refertotheFDAapprovedlabelingbythedrugmanufacturerandsyringemanufacturer,FDArequirementsandyourfacility’sestablishedprotocolsandproceduresfordeterminingthesuitabilityandcompatibilityofadesiredmedicationforusewiththesyringeslistedforusewiththeMedfusion®Model3500pumpV6.Priortousingasyringeforarouteofadministration,ensurethatthesyringeusedmeetstherequirementsforsterilityandpyrogenicityforthedesiredrouteofadministration.

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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.Alarm Loudness Definestheloudnesslevelofapump’salarm.Selectfromfivelevels—Level

1 (softest),Level 2,Level 3,Level 4,orLevel 5 (loudest).Thealarmcannotbedisabledorcompletelysilenced.

Alarm Silence Time DefinesthenumberofminutesuntiltheUserCallbackalarmwillsound.AlarmSilenceTimeisanumericvalueintherange1to2minutes.

Alarm Style Definesthetonestyleapumpwillusewhensoundinganalarm.Selectfromthreestyles-Medfusion® Defined,International StandardandMedfusion® Multi-tone.

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Medfusion® Model 3500 pump V6 Operator’s ManualAuto Lock Time Definesthenumberofsecondsthepumpwillwaitbeforeautomatically

lockingthepump’sinterface.AutoLockTimeisanumericvalueintherangeof0to999seconds.Settingthisvaluetozero(0)or(none)willdisabletheAuto Lockfeature.

Bolus Change in mL DefinesifapumpusercanchangeaBolus DoseorLoading DoseinmL.Selectfromtwovalues-EnabledorDisabled.

Bolus Time Feature DefinesifapumpuserwillneedtoenteratimewhensettingaBolus Dose in a manual delivery mode.Due to a conflict between Drug Program and Profile options, bolus time is always enabled in Drug Programs.Selectfromtwovalues-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.Selectfromtwovalues—EnabledorDisabled.

Flush DefinesiftheFlushfeatureswillbeavailableonthepump.Selectfromtwovalues—Enabledordisabled.

Flush Time Definesifauserwillbepromptedtoenteraflushtimewhenprogrammingaflushinfusion.Selectfromtwovalues—Enabledordisabled.

Maximum Flush Volume Definesthemaximumflushvolume(inmL)allowedbythepumpduringaflushinfusion.Maximumflushvolumeisanumericvaluefromtheminimumvolumeforthesyringetothefillvolumeofthesyringe.

FlowSentry™ DefinesiftheFlowSentry™pressuremonitoring(forrapidocclusiondetection)featureisenabled.Selectfromtwovalues—EnabledorDisabled.

FlowSentry™ Sensitivity DefinesthesensitivityoftheFlowSentry™pressuremonitoringalgorithmduringnormalinfusion.Selectfromfourvalues—Low - least sensitive,Normal,High,orVery High - most sensitive.

FlowSentry™ Startup Sensitivity DefinesthesensitivityoftheFlowSentry™pressuremonitoringalgorithmduringinfusionstartup.Selectfromfourvalues—Low - least sensitive,Normal,High,orVery High - most sensitive.

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

Maximum Body Surface Area DefinesthemaximumallowedvaluefortheBody Surface Areainfusionparameter.MaximumBodySurfaceAreaisanumericvalueintherangeof0.01to4m2.

Maximum Bolus Rate Definesthemaximumbolusinfusionrateallowedbythepump.Selectfromthreerates—Syringe Size x 5 mL/hr(example:5mLsyringe×5mL/hr=25mL/hrmaximumbolusrate),Syringe Size x 10 mL/hr (example:5mLsyringe

134

Medfusion® Model 3500 pump V6 Operator’s Manual×10mL/hr=50mL/hrmaximumbolusrate),orSyringe Size Max mL/hr (seethetableonpage129).

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

Maximum Patient Weight DefinesthemaximumallowedvalueforthePatient Weightinfusionparameter.MaximumPatientWeightisanumericvalueintherange0.25to250kg.

Near Empty Time Definesthenumberofminutesremainingbeforeasyringeisempty,atwhichtimeaSyringe Near Empty Alarmwilloccur.NearEmptyAlarmTimeisanumericvalueintherange0to240minutes.SettingthisvaluetozerowilldisabletheSyringe Near Empty Alarm.

Near Empty Alarm Priority DefinestheprioritylevelatwhichtogeneratetheSyringe Near Empty Alarm.Selectfromtwolevels—LoworMedium.

Occlusion Limit Definesthepressureatwhichthepumpwillconsiderthelineoccluded.Selectfromfourlimits—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 Allowssettingafour-digit passcodewhichtheusermustentertoaccesstheProfile.ProfilePasscodescanbeanynumericcodeintherangeof1000to9999.Ifsetto(none),nopasscodeisrequiredtoaccesstheProfile.

Program Display DefinesifthepumpwilldisplaythedeliveredProgram DoseorthedeliveredProgram Volume.Selectfromtwovalues:VolumeorDose.

Quick Library DefinestheLibraryCategorythatwillbeusedastheQuickLibrary.Syringe 1mL Support Definesif1mLsyringesupportisenabled,allowingtheuseof1mLsyringes.

Selectfromtwovalues—EnabledorDisabled.Unlock Passcode Definesthepasscodethatmustbeenteredatapumptounlockitsinterface.

UnlockPasscodescanbeanyfour-digitnumericcodeintherange1000to9999.Ifsetto(none),nopasscodeisrequiredtounlockthepump.

Auto Prompt OptionsAutoPromptOptionsareoptionalsettingsthattheuserwillbepromptedtoenterforallinfusionsinitiatedinthedefinedprofile.ThedefaultforallAutoPromptOptionsisDisabled.Bolus Dose DefinesifapumpuserwillbepromptedtoenteraBolus Doseduringinfusion

setup.Selectfromtwovalues—EnabledorDisabled.Confirm Settings DefinesifapumpuserwillbepromptedtoConfirm Infusion Settingswhen

settingupaninfusion.Oncetheinfusionsettingsaremade,ifConfirmSettingsisenabledtheuserwillberequiredtore-confirmthesettings.Selectfromtwovalues—EnabledorDisabled.

Enter User ID to Program DefinesifapumpuserwillbepromptedtoentertheirUser IDwhenprogramminganinfusion.Selectfromtwovalues—EnabledorDisabled.

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Medfusion® Model 3500 pump V6 Operator’s ManualPrompt to Prime DefinesifapumpuserwillbepromptedtoPrimeasalaststepinsettingupan

infusion.Selectfromtwovalues—EnabledorDisabled.Re-enter Weight Definesifapumpuserwillbepromptedtore-enterapatient’sweightto

confirmthesetting(adoublecheck).Selectfromtwovalues—EnabledorDisabled.

Standby Time DefinesifapumpuserwillbepromptedtoenteraStandbytimeduringinfusionsetup.Selectfromtwovalues—EnabledorDisabled.

Volume Limit DefinesifapumpuserwillbepromptedtoenteraVolume Limitduringinfusionsetup.Selectfromtwovalues—EnabledorDisabled.

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

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

Thisvaluecannotbesetorchangedwhileaninfusionisrunning.Loading Dose DefinesifapumpuserwillbeabletoenteraLoading Doseduringinfusion

setup.Override Alarm Loudness Definesifapumpuserwillbeabletochangetheloudnesslevelofapump’s

alarmduringaninfusion.Override Occlusion Limit Definesifapumpuserwillbeabletooverridetheprofiledefaultsettingof

thepressureatwhichthepumpwillconsiderthelineoccludedforthecurrentinfusion.

Periodic Callback Alarm DefinesifapumpuserwillbeabletoenteraPeriodic Callback Alarmtimeduringinfusionsetup.Therangeis0to8hours.

Standby DefinesifapumpuserwillbeabletoenteraStandbytimeduringinfusionsetup.Therangeis0to24hours.

Toggle Vol Empty Tone DefinesifapumpuserwillbeabletoenabletheSyringe Vol Empty AlarmToneforthecurrentinfusion.

Toggle FlowSentry™ DefinesifapumpuserwillbeabletodisabletheFlowSentry™pressuremonitor(forrapidocclusiondetection)featureforthecurrentinfusion.

Toggle Near Empty Tone DefinesifapumpuserwillbeabletodisabletheSyringe Near Empty Alarm Toneforthecurrentinfusion.

Toggle PVD/PDD Displayedonthepumpoptionsmenuas“ChangetoDose”or“ChangetoVolume.”DefinesifapumpuserwillbeabletochangetheprofiledefaultsettingtodisplaythedeliveredProgram DoseorthedeliveredProgram Volume.

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Medfusion® Model 3500 pump V6 Operator’s ManualVolume Limit DefinesifapumpuserwillbeabletoenteraVolume Limitduringinfusion

setup.Thisvaluecannotbesetorchangedwhileaninfusionisrunning.Therangeis0to500mL.

Device Setup FeaturesThefollowingitemsaresetonaperpumpbasisintheDeviceSetupmenu.Whilethesefeaturesdonotdirectlyaffectinfusionprogramming,theycanaffectalarmsandreporting.Serial Number Displaysthepumpserialnumber.Preventative maintenance date Definesthedatewhenthepump’spreventativemaintenancerequiredalarm

activates.Time Zone Definesthetimezonewherethepumpislocated.Daylight Saving DefinesifapumpwillautomaticallyswitchtoDaylightSavingTimeonthe

appropriatedate.Ifselected,specifywhenDaylightSavingbeginsandends,whattimetheclockschange,andbyhowmuch.

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

period(start-upcurves).2. Theaccuracyoffluiddeliveryofparticulartime

periodsor‘observationwindows’ismeasured(trumpetcurves).

Thestart-upcurvedisplaysflowratecontinuouslyfromthestartoftheinfusion.Thecurvevisuallyrepresentsflowrateuniformity.Trumpetcurvesarederivedfromthesecondhourofthisdata.TestswereperformedpertheIEC60601-2-24standard.Overlongobservationwindows,shorttermfluctuationshaveminimaleffectonaccuracyasrepresentedbytheflatpartofthecurve.Astheobservationwindowisreduced,shorttermfluctuationshaveanincreasingeffectasrepresentedbythe“mouth”ofthetrumpet.Beingawareofsystemaccuracyovervariousobservationwindowsmaybeofinterestwhencertaindrugsarebeingadministered.Shorttermfluctuationsinrateaccuracymayhave

clinicalimpactdependingonthehalf-lifeofthedrugbeinginfused,thereforeboththetrumpetcurveanddrughalf-lifeshouldbetakenintoaccount.ThedatawascreatedusingaMedfusion®pumpandBecton-Dickinson(B-D®)WWD30mLsyringe.The1mL/hrdatawascreatedusingtheMedfusion®536040Extensionsetand18Gneedle.The5mL/hrdatawascreatedusingtheMedfusion®MX448HL60Extensionsetand18Gneedle.

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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%

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Magnetic Resonance Imaging (MRI) InformationTheMedfusion®Model3500pumpV6isMRConditionalaccordingtotheterminologyspecifiedinASTMF2503-08,StandardPracticeforMarkingMedicalDevicesandOtherItemsforSafetyintheMagneticResonanceEnvironment.Non-clinicaltestingdemonstratedthattheMedfusion®Model3500pumpV6isMRConditional.ThepumpwillnotpresentahazardorrisktothepatientorMRuser,orsignificantlyaffecttheMRimagequalityifthepumpisoperatedaccordingtothespecificguidelinesasfollows:

WARNING:ThepumpmustbepositionedinanMRenvironmentsuchthatitissecured to a non-moveable objectandthemagneticfringefielddoes not exceed 150 gauss.ExposingtheMedfusion®Model3500pumpV6tomagneticfieldsthatexceed150gausspresentsariskofbecomingaprojectilehazardandcanleadtopossiblepatientinjuryordeath.Irreversibledamagetothepumpcanalsooccur,renderingitinoperable.

MRI Related TestingInnon-clinicaltesting,theMedfusion®Model3500pumpV6evaluationshaveincludedMagneticAttraction(projectilehazard),MRinterferencewiththepump,andMRImageDistortion.• MagneticAttraction(projectilehazard):The

Medfusion®Model3500pumpV6showednoattractiontorqueorforceat150gaussstaticmagneticfieldstrength.

• MRInterferencewiththePump:TheMedfusion®Model3500pumpV6operatednormallywhileinthe150gaussstaticmagneticfield.

• MRImageDistortion:NoMRimaginginterferencewasobservedwhentestedwiththeMedfusion®Model3500pumpV6at8feetfromtheisocenterofa1.5T(64MHz)SiemensSymphonyMRsystem,SiemensSoftware2002RevisionC,underthefollowingconditions:batteryonly(noACcord),backofthepumpfacingtheMRIisocenter,fullbodyreceivercoil(mostsensitive),usingstandardspinecho,fastspinechoandgradientspinechopulsesequences.

Image DistortionCertainMRIreceivercoilsaresensitivetoelectronicemissions.Therefore,priortopatientexaminations,MRimagescansshouldbecompletedwhileoperatingtheMedfusion®Model3500pumpV6intheMRenvironmentthatistobeusedfortheexaminationtoverifyacceptableMRimagequality.NotethatresultsvarybetweenMRIsystemsduetodifferencesinscanningsystemsandreceiversused.Thefollowingaretipstominimizethepossibilityofimageartifactsappearing:• EnsurethatthebackofthepumpfacestheMRI

isocenterduringoperation(pumpscreenfacingawayfromtheMRI.

• MovethepumpfurtherfromtheisocenteroftheMRIsystemifimageartifactsappear.

• OperatetheMedfusion®Model3500pumpV6onbatterypowerinanMRenvironment.ThepresenceofapoweredACcordtypicallyinducesimageartifacts.

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

whereapplicable• DecreasethePhaseEncodingmatrix• IncreasetheacquisitionFieldofView• Increasetheslicethickness• Increasethenumberofaverages

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Cleaning and careBelowarecommonmethodsandcautionsrelatingtocleaningandcaringfortheinfusionpump.

WARNING: Power Source:Toavoidelectricshock,beforecleaning,alwaysswitchelectricallyoperatedequipmentoffanddisconnectfromACpowersource.

CAUTIONS: • DO NOT USEcleaningsolutionscontaining: acetone,ammonia,ammonium chloride(including

Hyamine1622),aromatic solvents(suchaspaintthinner,toluene,methylbenzene),chlorinated solvents(suchasmethylethylketone(MEK),trichloroethane),ether(suchasethyleneglycolmonobutylether,diethyleneglycolbutylether)oroxidizing acids(suchasphosphoricacid,sulfuricacidoracceleratedhydrogenperoxide).

UseofthesolutionsorsolventslistedasDONOTUSEcoulddamageplasticpartsandcauseprematurefailureordevicemalfunction.

• Use only the recommended cleaning/disinfecting agents and method.Useofcleaning/disinfectingagentsandmethodotherthanthoselistedmaycausedamagetothepumpandwillvoidthewarranty.

• 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. Thefollowingagentshavebeentestedandcanbeusedtosafelycleanthesyringepumpwithoutdamagingthepumphousingwhentheprocedurelistedinitem2,below,isused:• Isopropylalcohol70%solution• Householdbleach(Sodium

Hypochlorite),(6%solutiondilutedto1:6)or1.0%

• Sani-Cloth®BleachbyPDI• Milddetergentmixedwithwater(has

nodisinfectionproperties)2. Cleanbysprayingcleaningagentdirectly

ontoasoftcloth(orusewipes/clothslisted)andwipepump,thenwipesurfacesdry.Neverallowcleaningagentstopoolonthedeviceasprolongedcontactcoulddamagethepumpanditscomponents.

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Maintenance & serviceThischapterincludesinformationrelatingtobothstandardmaintenanceandservice.

WARNINGS: • PumpMaintenance.Toavoidelectricshock,only

trainedbiomedicalservicepersonnelmayservicethispump.ServicepersonnelshoulddisconnecttheACpowercordbeforeservicingthepump.

• ShockHazard:TheonlymeansofremovingACpoweristodisconnecttheACpowercord.WhiletheACpowercordisattachedtothepumpandpluggedintoanACoutlet,livemainvoltageispresentwithinthepump.

• ManufacturerRecommendedMaintenance:Alwaysmaintainthispumpfollowingmanufacturer recommended instructionsintheTechnical Service Manual.Improperlymaintainedpumpsmaycauseeitherunder-infusionorover-infusiontopatient.

• NeverOpenthePumpCase:Toavoidelectricshock,usersshouldneveropenthepumpcaseorbatterycompartmentforanyreason.ServicepersonnelshouldalwaysdisconnecttheACpowercordbeforeservicingthepump.

• DroppedorDamagedPumps:Neveruseadroppedorobviouslydamagedpump.Withdrawitfromserviceuntilatrainedbiomedicaltechniciancantestit.

Periodic maintenanceTrainedbiomedicalservicepersonnelshouldtestthepumpatleastyearlytoensurecontinuedsafeoperation.

• Thistestingshouldbeperformedatleastyearly,orwheneverthepumphasbeendamagedordropped.

• Theocclusionandother sensorsmustbecheckedyearly.

• RefertotheTechnical Service Manualforspecificdetails.

ThePharmGuard® Toolbox 2 User’s Manual(providedwiththePharmGuard®Toolbox2software)providesinformationoncustomizingthesettingsandfeaturesofthepump,whichinturnaffecttheuseandoperationofthepumponadailybasis.TheMedfusion® Model 3000 Series Technical Service Manual,(catalognumberG6000278)providestechnicalinformationonthispump,including:• FunctionalDescriptions• Calibration• Pumpteaching,learning,cloning• TheoryofOperation• DiagnosisandTesting• ServiceParts*ContactSmithsMedicalforavailability.*Includingreplacementbatterypacksandpowercords

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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,contactyourlocaldistributorforserviceassistance.

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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.

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Collect Separately

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

Thisproductcontainselectricalandelectroniccomponents(includingbatteries)thatmaycontainmaterialswhich,ifdisposedofwithgeneralwaste,couldbedamagingtotheenvironment.InaccordancewithDirective2002/96/ECWasteElectricalandElectronicEquipment,residentsoftheEuropeanUnionmustfollowspecificdisposalorrecyclinginstructionsforthisproduct.Contactyourlocaldistributor,orvisitthefollowingwebsiteforspecificinstructions:http://www.smiths-medical.com/recycle/index.htmlNon-EuropeanUnionresidentsmustdisposeoforrecyclethisproduct(includingbatteries)inaccordancewiththelocallawsorregulationsthatapply.

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Limited WarrantySmithsMedicalASD,Inc.(the“Manufacturer”)warrantstotheOriginal Purchaser that the Medfusion® Syringe Pump Model3500 V6 (the “Pump”), not including accessories, shall be freefromdefectsinmaterialsandworkmanshipundernormaluse,ifusedinaccordancewiththisOperator’sManual,foraperiodofone(1)yearfromtheactualdateofsaletotheOriginalPurchaser.THEREARENOOTHERWARRANTIES.

This warranty does not cover normal wear and tear andmaintenance items, and specifically excludes batteries,administrationsets,extensionsetsoranyotheraccessoryitemsorequipmentusedwiththePump.

Subject to the conditions of and upon compliance with thisLimitedWarranty,theManufacturerwillrepairorreplaceatitsoptionwithoutcharge(exceptforaminimalchargeforpostageand handling) any Pump (not including accessories) which isdefectiveifaclaimismadeduringsuchone-yearperiod.

Thefollowingconditions,procedures,andlimitationsapplytotheManufacturer’sobligationunderthiswarranty:

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

B. Warranty Performance Procedure: Notice of theclaimed defect must be made in writing or by telephone tothe Manufacturer as follows: Customer Service Department,Smiths Medical ASD, Inc., 1265GreyFoxRoad, St.Paul,MN55112USA,1800.258.5361(USA).NoticetotheManufacturermust include date of purchase, model and serial number, anda description of the claimed defect in sufficient detail to allowtheManufacturer todetermineand facilitate any repairswhichmaybenecessary.AUTHORIZATIONMUSTBEOBTAINEDPRIOR TO RETURNING THE PUMP. If authorized, thePumpmustbeproperlyandcarefullypackagedandreturnedtotheManufacturer, postageprepaid.Any loss ordamageduringshipmentisattheriskofthesender.

C. Conditions of Warranty:ThewarrantyisvoidifthePumphasbeen1)repairedbysomeoneotherthantheManufacturerorits authorized agent; 2) altered so that its stability or reliabilityis affected (which includesuseof service/replacementpartsnotsupplied by SmithsMedical or its authorized agents, includingthe battery pack); 3) misused; or, 4) damaged by negligenceor accident. Misuse includes, but is not limited to, use not incompliancewiththeOperator’sManualorusewithnon-approvedaccessories.RemovalordamagetothePump’sserialnumberwillinvalidatethiswarranty.

D. Limitations and Exclusions:Repairor replacementof thePumporanycomponentpartthereofistheEXCLUSIVE remedyoffered by the Manufacturer. The following exclusions andlimitationsshallapply:

1. Noagent,representative,oremployeeoftheManufacturerhasauthoritytobindtheManufacturertoanyrepresentationorwarranty,expressedorimplied.

2. THEREISNOWARRANTYOFMERCHANTABILITYOR FITNESS OR USE OF THE PUMP FOR ANYPARTICULARPURPOSE.

3. The Pump can only be used under the supervision ofmedical personnel whose skill and judgment determine thesuitabilityofthePumpforanyparticularmedicaltreatment.

4. All recommendations, information, and descriptiveliterature supplied by the Manufacturer or its agents arebelieved to be accurate and reliable, but do not constitutewarranties.

E. Computer Program License:

1.The Pump is intended to be used in conjunction witha particular Licensed Computer Program supplied byManufactureranduseofanyotherprogramorunauthorizedmodification of a Licensed Computer Program shall voidManufacturer’swarrantyassetforthabove.

2.The Original Purchaser and any users authorized bythe Original Purchaser are hereby granted a nonexclusive,nontransferable license to use the Licensed ComputerProgramonlyinconjunctionwiththesinglePumpsuppliedbyManufacturer.TheLicensedComputerProgramissuppliedonlyinmachine-readableobjectcodeformandisbaseduponManufacturer’s proprietary confidential information. Norightsaregrantedunderthislicenseorotherwisetodecompile,producehumanlyreadablecopiesof,reverseengineer,modifyor create any derivative works based upon the LicensedComputerProgram.

3. Allother termsandconditionsof thisLimitedWarrantyshallapplytotheLicensedComputerProgram.

The Manufacturer disclaims responsibility for the suitabilityof the Pump for any particular medical treatment or for anymedicalcomplicationsresulting fromtheuseof thePump.TheManufacturershallnotberesponsibleforanyincidentaldamagesorconsequentialdamagestoproperty,lossofprofits,orlossofusecausedbyanydefectormalfunctionofthePump.

Thiswarranty gives theOriginalPurchaser specific legal rights,andtheOriginalPurchasermayhaveotherlegalrightswhichmayvaryfromstatetostate.

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IndexA

ACpowerconnectionport7,110Alarms&alerts99Troubleshooting103

BBattery110BatteryAlarms107guidelines111Onscreenpowergauge111

Bodyweight/surfaceareainfusions44Bolusdosing60Bolusratereduction64,106Continuing/restartingabolusdose63

CChangingrate94duringdelivery94whenpaused95

Cleaningthepump139Concentrationanddosingunits131Configuration5,10,132Configurationprofile28Continuingabolusdose63Continuingaloadingdose69Continuousmode:ml/hr37

DDataHandlingSoftwareSafetyFeatures126Delayedstart78,87Deliveringaloadingdose68Deliverymode31Display7Dose/Day40Dose/Hr38Dose/Min38Dose/Time42

EECMO(ExtracorporealMembraneOxygenation)6ElectromagneticCompliance(EMC)114Explosionriskwarning1

FFlowSentryrapidocclusiondetection5,92Flushfeature88,133

GGeneralUseDiagram21

HHardlimits12,17,131Hardware-relatedSoftwareSafetyFeatures126hyperbaricchamberusewarning1

IIntermittentvolume/time53

KKeepVeinOpen(KVO)rate74Keypad8buttons(orkeys)9Indicators9

Keypadlock98Unlocking98

LLibrariesQuick13Standard13

Loadingasyringe32Unloadingasyringe36

Loadingdose66Continuing/restartingaloadingdose69Deliveringaloadingdose68Loadingdoseratereduction70

Lockingthekeypad98

MMaintenance&service140Mode12,31Bodyweight/surfaceareainfusions44Continuous37Dose/Day40Dose/Hr38Dose/Min38Dose/Time42IntermittentVolume/Time53Recalllastsettings55Volume/Time52

MRI(MagneticResonanceImaging)138

NNearemptyalarmtone,disable/enable84

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OOcclusionsettings92Postocclusionbolusreduction93

Options59,135Bolusdosing60Delayedstart78,87Disable/enablenearemptyalarmtone84Disable/enablerapidocclusiondetection84Disable/enablevolemptyalarmtone85KVO(KeepVeinOpen)74Loadingdose66Deliveringaloadingdose68

Overridealarmloudness83Overrideocclusionlimit82Perioodiccallbackalarm79Standby76

Overridealarmloudness83Overrideocclusionlimit82

PPeriodiccallbackalarm79PharmGuardSafetySoftware5,13,17,29,131Poleclamp112rotating/detachablepoleclampAssembling113

Postocclusionbolusreduction93Primefunction34,55ProgramDoseDelivered(PDD)96Clearing97Displaying96

ProgramVolumeDelivered(PVD)96Clearing97Displaying96

QQuicklibraries13

RRapidocclusiondetection,disable/enable84Ratereduction64,70,106Recalllastsettings55Restartingabolusdose63Restartingaloadingdose69

SSelf-tests24Service140Softlimits12,17,131SoftwareSafetyFeatures126DataHandlingSoftwareSafetyFeatures126Hardware-relatedSoftwareSafetyFeatures126

Standardlibraries13Using14

Standby76,87Startinganinfusion86frompause86fromstandby,delayedstart87Stoppinganinfusion87

Stoppingdelivery87Symbols4Syringebarrelclamp7,33,34Syringebarrelflangeclip7,33Syringemanufacturer/type37Syringeplungerdriver7,34Syringeplungerholders7Syringeplungerreleaselever7,33,34SystemAdvisory107SystemFailures102,108

TTechnicalspecifications122Concentrationanddosingunits131Flowdeliverygraphs(trumpetcurves)136Options135PharmGuardlimits131

TotalVolumeDelivered96Clearing97

Trumpetcurves(flowdeliverygraphs)136Tubingholders7,35Turningthepumpoff25

UUnloadingasyringe36Unlockingthekeypad98UserCallbackalarm101

VVolEmptyalarmtone,disable/enable85Volume/time-ml/hrinfusions52

Wwatchdog126WorkflowProcess21

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s

Smiths Medical ASD, Inc.1265 Grey Fox Road, St. Paul, MN 55112 USA1 800.258.5361 (USA), 1 214.618.0218www.smiths-medical.com

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 mentioned are the trade names, trademarks or service marks of their respective owners.

© 2013 Smiths Medical. All rights reserved.2013-04 40-6370-01A

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Medfusion® Syringe Pump Model 3500 Operator's Manual

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Transcript of Medfusion® Syringe Pump Model 3500 Operator's Manual