M A N U FA C T U R E D B Y:

Kimberly-Clark1400 Holcomb Bridge RoadRoswell, GA 30076 USA

Kimberly-Clark N.V.Da Vincilaan 11935 Zaventem, Belgium

Instructions For Use

ON-Q* Pump with Select-A-Flow* Variable Rate Controller

X ml/Y min

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IMPORTANT INFORMATION

Please read the entire document before operating the ON-Q* device. Follow all instructions carefully to ensure the safety of patient and/or user.

USER INFORMATION • For24-hourProductSupport,call800-444-2728or

+1-949-923-2400(Englishonly).• Visitwww.iflo.com or contact your sales representative

for the latest product information and Technical Bulletins,includingbutnotlimitedto:• ON-Q*withSelect-A-Flow*,DrugDosingInformation

Technical Bulletin• UseofON-Q*PumpinMagneticResonance(MR)

environment• LatexSensitivity• ContinuousInfusioninPediatricPatients• UseofON-Q*PumpinHandandFootSurgeryVolumeandFlowRateSelection• WhatWeKnowAboutChondrolysisToday• UseofON-Q*withPerioperativeAutologousBlood

TransfusionSystems• USP797• EffectofStorageTimesonFlowRateonPre-filled

ON-Q*ElastomericPumps• PatientGuidelines

WARNINGFlowrateisadjustable.Medicationdosageshouldbebasedonmaximumflowrate.Toreducepotentialadverseevents:

• Medicationdosingshouldbebasedonthemaximumflowrate(7or14ml/hr).

• Theamountofmedicationoverthetherapeuticperiod and delivery time can vary by as much as 20%.Takethisvarianceintoconsiderationwhendetermining medication delivery.

• Regardlessoftheprescribedflowrate,onlyfillthepump with medication dosage that is appropriate to administeratthemaximumflowrate.

• Duetoriskofischemicinjury,vasoconstrictorssuchas epinephrine are not recommended for continuous infusionsforthefollowingroutesofadministration:

intraoperativesite,perineuralandpercutaneous(excludingepidural).

• Medicationsorfluidsmustbeadministeredperinstructions provided by the drug manufacturer. Physician is responsible for prescribing drug based on eachpatient’sclinicalstatus(suchasage,bodyweight,diseasestateofpatient,concomitantmedications,etc.).

• Thereisnoalarmoralertwhenflowinterruptionoccurs,therefore,life-supportingmedicationswhoseusagemay cause serious injury or death due to stoppage or under-delivery are not recommended for infusion with the ON-Q* device.

• Thereisnoindicatorofpumpinfusionstatus,therefore,use caution where over-delivery of medications could result in serious injury or death.

• Epiduralinfusionofanalgesicsislimitedtousesofindwellingcathetersspecificallydesignedforepiduraldelivery. To prevent infusion of drugs not indicated forepiduraluse,donotuseIVsetwithadditiveports.Itisstronglyrecommendedthatdevicesusedforadministration of medication via epidural routes be clearlydifferentiatedfromallotherinfusiondevices.

• Toavoidcomplications,usethelowestflowrate,volumeand drug concentration required to produce the desired result.Inparticular:• Avoidplacingthecatheterinthedistalendof

extremities(suchasfingers,toes,nose,ears,penis,etc.)wherefluidmaybuildupasthismayleadtoischemic injury or necrosis.

• Avoidplacingthecatheterinjointspaces.Althoughthereisnodefinitiveestablishedcausalrelationship,some literature has shown a possible association between continuous intra-articular infusions (particularlywithbupivacaine)andthesubsequentdevelopment of chondrolysis.

• Avoidtightwrappingswhichcanlimitbloodsupplyorfluiddiffusion.

• Itistheresponsibilityofthehealthcareprovidertoensurepatient is educated on the proper use of the system.

• ItistheresponsibilityofthehealthcareprovidertomodifyPatientGuidelinesprovidedwiththepumpasappropriatefor your patients’ clinical status and medication prescribed.

ON-Q* Pump with Select-A-Flow* Variable Rate ControllerInstructions For Use

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• Donotaddunventedfiltertoendoftheadministrationsetasthismayimpedeorstoptheflowrate.

• Flow rates may vary due to:

Fill volume•Fillingthepumpless than the labeled volume results in fasterflowrate.

•Fillingthepumpgreater than the labeled results in slowerflowrate.

• Viscosity and/or drug concentration.• Pump position-positionthepumpatapproximatelythe

samelevelasthecathetersite:• Positioningthepumpabove this level increasesflowrate.• Positioningthepumpbelow this level decreasesflowrate.

Temperature • TheSelect-A-Flow*deviceshouldbewornoutside

clothingandkeptatroomtemperature.• Toensureflowrateaccuracy,donotplaceheatorcold

therapyincloseproximitytotheflowcontroller.• Temperaturewillaffectsolutionviscosity,resultingin

fasterorslowerflowrate.• Select-A-Flow*devicehavebeencalibrated

usingNormalSaline(NS)asthediluentandroomtemperature(22°C,72°F)astheoperatingenvironment.Flowratewillincreaseapproximately1.4%per1°F/0.6°Cincreaseintemperatureandwilldecreaseapproximately1.4%per1°F/0.6°Cdecreasein temperature.

• Ifrefrigerated,allowpumptoreachroomtemperaturebefore using.

•Itmaytakeapproximately8-18hoursforapumptoreachroomtemperature.(Seetablebelow)

Fill Volume (ml) 100 200 270 400 600

Refrigerator to Room Temp (hr) 8 12 12 15 18

Storage• StorageofafilledON-Q*Pumpformorethan8hours

prior to starting infusion may result in a slower flowrate.

External pressure• Externalpressuresuchassqueezingorlayingonthe

pumpincreasesflowrate.

CAUTION

• Donotuseifpackageisopen,damagedoraprotector cap is missing.

• Singleuseonly.Donotresterilize,refillorreuse.

Reuseofthedevicecouldresultinthefollowingrisks: •Improperfunctioningofthedevice(i.e.,inaccurateflowrate) •Increasedriskofinfection

•Occlusionofthedevice(i.e.,impedesorstopsinfusion)• Thepumpissterileandnon-pyrogenic.• ProductusesDi(2-ethylhexyl)phthalate(DEHP)

plasticizedPVC:• DEHPisacommonlyusedplasticizerinmedical

devices.ThereisnoconclusivescientificevidencetodatethatexposuretoDEHPhasaharmfuleffectonhumans.However,theriskandbenefitofusingmedicaldeviceswithDEHPforpregnantwomen,breastfeedingmothers,infantsandchildrenshouldbeevaluated prior to use.

• CertainsolutionsmaybeincompatiblewiththePVCmaterialusedintheadministrationset.Consultdrugpackageinsertandotheravailablesourcesofinformation for a more thorough understanding of possible incompatibility problems.

• Donotunderfillpump.Underfilling the pump may significantlyincreasetheflowrate.

• Donotexceedmaximumfillvolume.(Table1)• Thefillvolumeandinfusionratearelabeledonthefillport.• Flowrateisunpredictableifitisdialedbetweenrate

settings. • Clampisprovidedtostoptheinfusion.Donotremoveor

breakclamp.Donotuseclampasanintermittent delivery device.

• Rolltubingbetweenfingerstopromoteflowifclampedforextendedtime.

• Avoidcontactofcleansingagents(likesoapandalcohol) withthefilterbecauseleakagemayoccurfromtheaireliminating vent.

• Donottapeoverfilter(s)asthiscouldblocktheairventand impede the infusion.

• Donotimmersethepumpinwater.Takecaretoprotectthepumpduringanyactivities,whichcouldcausethepumpandfiltertogetwet,suchasshowering.

• Intheeventofanyleakagefromthepumporadministrationset,closetubingclamp.Replacepump if necessary. • DonotdiscardthepumpandcontactI-Flow*for

product return instructions.

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INDICATIONS FOR USE• TheON-Q*pumpisintendedtoprovidecontinuous

deliveryofmedication(suchaslocalanesthetics)tooraroundsurgicalwoundsitesand/orcloseproximitytonervesforpreoperative,perioperativeandpostoperativeregionalanesthesiaand/orpainmanagement.Routesofadministrationinclude:intraoperativesite,perineural,percutaneous and epidural.

• ON-Q*pumpisindicatedtosignificantlydecreasepainand narcotic use when used to deliver local anesthetics tooraroundsurgicalwoundsites,orcloseproximitytonerves,whencomparedtonarcoticonlypainmanagement.

CONTRAINDICATIONS • ON-Q*Pumpisnotintendedforblood,bloodproducts,

lipids,fatemulsions,orTotalParenteralNutrition(TPN).• ON-Q*Pumpisnotintendedforintravasculardelivery.

DESCRIPTION OF DEVICE Figure 1TheON-Q*PumpwithSelect-A-Flow*deviceincorporatesacontroller that allows the user to adjust the infusion rate.

1 Fill Port 2 ON-Q* Pump 3 Clamp 4 Air-EliminatingFilter 5 Select-A-Flow*VariableRateController6FlowRateDial7 Rate-ChangingKey8 LockableCoverFigure 1

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SELECT-A-FLOW* DEVICE DESCRIPTIONSelect-A-Flow*deviceisaflowcontrollerthatallowstheusertoadjusttheinfusionratebyturningtherate-changingkeyonthedevice.Theflowrateiswithinapredeterminedrangeand is designated on each device.

Figure 2

TO DISCOURAGE TAMPERING: (Figure 2)1. Removetherate-changingkeyfromthedialbypulling

thekeystraightout.Putthekeyinasafeplaceforlateruse,e.g.,attachedtoakeyring.

2. ClosethecoverovertheSelect-A-Flow*VariableRateController.

3. Forincreasedtamperresistance,thecovermaybelockedtotheSelect-A-Flow*VariableRateControllerusingthetie-wrap.

Note:Ifdesired,thecovermayalsoberemovedfromtheSelect-A-Flow*devicebyfullyopeningthecoverandthenpulling straight up on the plastic feet at the bottom of the cover.

WARNING: Do not rely on the Select-A-Flow* key or tie-wrap to prevent patient tampering.

Select-A-Flow*deviceisavailableintwoflowraterangesanddistinquishedbycoloronthefaceofdevice:

Green (1-7 ml/hr) • Flow rate dial -1,2,3,4,5,6,7ml/hr

White (2-14 ml/hr) • Flow rate dial -2,4,6,8,10,12,14ml/hr

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INSTRUCTIONS FOR USEUse Aseptic Technique

FILLING THE ON-Q* PUMP: (Figure 3)Note: Follow hospital protocols and applicable regulations forfillingpump.

1. Closeclamp.2. Uncapthefillport.3. Attachfilledsyringetofillport.Invertpumpasshown.4. Graspsyringewithbothhands.5. Push down on plunger continuously until volume is

dispensed.Donothandlepumpwhilefilling,asthesyringetipmaybreak.Repeatasnecessary.Syringeaccuracyis±4%.

Note:FillingExtensionSetsareprovidedwithlargerpumps(seeproductinsert).

6. Removefillingdevicefromfillport7. Replacefillportcap.Labelwithappropriate

pharmaceutical and patient information.Figure 3

FILL VOLUME

CAUTION: Donotunderfillpump.Underfilling the pumpmaysignificantlyincreasetheflowrate.Donotexceedmaximumfillvolume.(Table1)

Table 1: Fill Volume (ml)

Fill Volume 100 200 270 400 600

Max Fill Volume 125 335 335 550 750

Retained Volume ≤5 ≤11 ≤11 ≤16 ≤23

WARNING: Flow rate is adjustable. Medication dosage should be based on maximum flow rate. Pump is pre-set at 7 ml/hr or 14 ml/hr (depending on model).

Table 2: 24-Hour Dosing Reference

Select-A-Flow* ModelDrug Concentration (mg)

0.2% 0.25% 0.5%

7ml/hrMaxFlowRate 336 420 840

14ml/hrMaxFlowRate 672 840 1680

Formula: ml/hr x % drug concentration x 10 x 24 hr = 24 hour dose (mg)

CAUTION: Calculationsbasedonthelabeledflowrate.Flow rate accuracy varies.

PRIMING THE ADMINISTRATION SET

Use Aseptic Technique

Note:Select-A-Flow*deviceispackagedwiththeflowrate atthehighestsettingtominimizeprimingtime.

1. OpentheplasticcoveroftheSelect-A-Flow*device2. TobeginprimingtheSelect-A-Flow*device,ensure

highestflowratesettingisselected.• Makesuretheselectedflowrateisalignedbelowthe

ml/hr xmark.•Thetactilefeelwillallowtheusertoensureselected flowrateisset.

3. Opentheclampandremovetubingcaptobeginpriming.4. Whenallairhasbeenremovedfromtheentiretubingand

fluidisobservedatendofluerlock,theadministrationsetis primed.

5. Turnthedialbacktoø,offpositionandclosetheclamp.6. Replacetubingcapuntilreadyforuse.

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STARTING INFUSIONUse Aseptic Technique

1. Connecttubingtopatient’scatheter.Makesureconnection is secure.

2. SelecttheappropriateflowratebyturningthedialontheSelect-A-Flow*deviceuntiltheflowratesettingisaligned with the ml/hr xmarkonthefaceoftheSelect-A-Flow*device(Figure4).• Theorientationoftherate-changingkeydoes not indicatetheflowrateselection.

•Thetactilefeelwillallowtheusertoensureselectedflowrateisset.

Figure 4 Examples of flow rate settings 3 ml/hr 6 ml/hr

CAUTION: Dialmustbealignedwithnumberand▼ to ensureaccurateflowrate.Donotdialbetweennumbers.Flowrate is unpredictable if dialed between numbers (Figure5).

Figure 5

3. Openclamp.

Correct alignmentIncorrect alignment

CHANGING THE FLOW RATE DURING AN INFUSION1. Inserttherate-changingkeyintothedialofthe

Select-A-Flow*device.2. Turnthedialuntilthenewflowrateisselected.Makesure

theselectedflowratesettingisalignedwiththeml/hrx markonthefaceoftheSelect-A-Flow*device.Thetactilefeelwillallowtheusertoensureselectedflowrateisset.

3. Removethekeyfromthedialandputinasafeplaceforlater

DURING THE INFUSION:• Achangeinappearanceandsizeofthepumpmaynotbe

evidentduringthefirst24hoursafterstartofinfusion.• Asmedicationisdelivered,thepumpwillgradually

become smaller.• Makesure: •Clampisopen •Therearenokinksinthetubing •Filterventisnottapedorcovered

•Heat,iceorcoldtherapyisplacedawayfromtheflow controller

END OF INFUSION: •Infusioniscompletewhenpumpisnolongerinflated.• Closeclamp,disconnectanddisposeofthepump

according to your institution’s protocol.

Note: Ifpumpdidnotperformasexpecteddonotdiscard.ContactI-Flow*forproductreturninstructions:ifloproductcomplaint@kcc.com.

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TECHNICAL SPECIFICATIONSDELIVERY ACCURACY:Whenfilledtothelabeledvolume, Select-A-Flow*devicedeliveryaccuracyis±20%ofthelabeledrateswheninfusionisstarted0-8hoursafterfillanddeliveringnormalsalineasadiluentat22°C/72°F.

TYPICAL FLOW CURVE Figure 6

Typical Flow Curve

FlowRate

PercentDeliveryTime 100%

Nominal

Theflowratemaybehigherorloweratthebeginningandendoftheinfusion(Figure6).

NOTE:Latex is not in fluid pathway or in contact with human. Refer to ON-Q* Pump Latex Sensitivity Technical Bulletin at www.iflo.com.

STORAGE CONDITIONSStoreundergeneralwarehouseconditions.Protectfromlightsourcesandheat.Keepdry.

Rx only=CAUTION:Federal(U.S.A.)lawrestrictsthisdevice to sale by or on the order of a physician. AdditionalU.SandForeignPatentsmaybeissuedand/orpending.*RegisteredTrademarkorTrademarkofKimberly-ClarkWorldwide,Inc.oritsaffiliates.©2010KCWW.AllRightsReserved.

For more information, please call +1.949.923.2400 • 1.800.448.3569 (English only) or visit www.iflo.com for the latest product information and Technical Bulletins.

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14-60-613-0-0470159789

2014-03-12

Distributed in the U.S. by I-Flow, LLC, located in USA.I-Flow* is a Kimberly-Clark Health Care Company. *Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc. or its affiliates. © 2010 KCWW. All Rights Reserved.

M A N U FA C T U R E D B Y:

Kimberly-Clark1400 Holcomb Bridge RoadRoswell, GA 30076 USA

Kimberly-Clark N.V.Da Vincilaan 11935 Zaventem, Belgium

A K I M B E R L Y - C L A R K H E A L T H C A R E C O M P A N Y

For Customer Service please call:

+1.949.923.2400 • 1.800.448.3569 English onlyiflo.com