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INSTRUCTIONS FOR USE
ABThera™ SensaT.R.A.C.™
Open Abdomen Dressing
Only for use with Negative Pressure Therapy
provided by InfoV.A.C.®, V.A.C.® ATS
or V.A.C.Ulta™ Therapy Units
PRODUCT DESCRIPTION
TheABThera™SensaT.R.A.C.™OpenAbdomenDressing,whenusedwithNegativePressureTherapy
providedbytheInfoV.A.C.®,V.A.C.®ATSandV.A.C.Ulta™TherapyUnitsprovidesanactivetemporary
abdominalclosuresystem,designedtoremovefluidsfromtheabdominalcavityanddrawwound
edgestogether,helpingtoachieveprimaryfascialclosurewhileprotectingabdominalcontents
fromexternalcontaminates.
SAFETy INFORMATION
IMPORTANT:Aswithanyprescriptionmedicaldevice,failuretoconsultaphysicianandcarefully
readandfollowalltherapyunitanddressinginstructionsandsafetyinformationpriortoeachuse
mayleadtoimproperproductperformanceandthepotentialforseriousorfatalinjury.Donot
adjusttherapyunitsettingsorperformtherapyapplicationwithoutdirectionsfrom/orsupervision
bytheclinicalcaregiver.
AlldisposablecomponentsoftheABThera™SensaT.R.A.C.™OpenAbdomenDressingareforsingle
useonly.Re-useofdisposablecomponentsmayresultinwoundcontamination,infectionand/or
failureofthewoundtoheal.
INDICATIONS FOR USE
TheABThera™SensaT.R.A.C.™OpenAbdomenDressingisindicatedfortemporarybridgingof
abdominalwallopeningswhereprimaryclosureisnotpossibleand/orrepeatabdominalentries
arenecessary.Theintendeduseofthisdressingisinopenabdominalwoundswithexposedviscera
including,butnotlimitedto,abdominalcompartmentsyndrome.Theintendedcaresettingisa
closelymonitoredareawithintheacutecarehospital,suchastheICU.Theabdominaldressingwill
mostoftenbeappliedintheoperatingtheater.
CONTRAINDICATIONS
• Neverplaceexposedfoammaterialdirectlyincontactwithexposedbowel,organs,blood
vesselsornerves.ProtectvitalstructureswiththeVisceralProtectiveLayerat all timesduring
therapy.
• Patientswithopenabdominalwoundscontainingnon-entericunexploredfistulasshouldnotbe
treatedwiththeABThera™SensaT.R.A.C.™OpenAbdomenDressing.
Managementoftheopenabdomenhasbeendocumentedincasereportsandconsensuspanel
literature.PleaserefertotheReferences Listsectionofthisdocument.
WARNINGS
Not for use with Instillation Therapy: Although it is accepted medical practice to flush a
contaminatedopenabdominalcavitywithsalineorothermedicalsolutions,theABThera™
SensaT.R.A.C.™OpenAbdomenDressingwasnotdesignedforthispurpose,andKCIhasnostudies
tosupportitssafeandeffectiveusewithinstillationtherapy.Potentialrisksofinstillationintothe
openabdomeninclude:
• Instillationoffluidintheabdomenwithoutsufficientfluidrecoverymayleadtoabdominal
compartmentsyndrome.
• Instillationoffluidsintheabdomenthatareuntestedforsafetyandefficacywiththisapplication
couldleadtoseverehollowviscusandsolidorgandamage.
• Non-suturedhemostaticagents(forexample,bonewax,absorbablegelatinspongeorspray
woundsealant)appliedintheabdomenmay,ifdisrupted,increasetheriskofbleeding.Protect
againstdislodgingsuchagents.
• Infectionintheabdominalwoundmayweakenvisceralorgansandassociatedvasculature,
whichmayincreasesusceptibilitytobleeding.
• Useofanticoagulantsorplateletaggregationinhibitors.
• Bonefragmentsorsharpedgescouldpuncturevesselsorabdominalorgans.Bewareofpossible
shiftingintherelativepositionoftissues,vesselsororganswithintheabdominalwoundthat
mightincreasethepossibilityofcontactwithsharpedges.
Intra-abdominal Pressure Monitoring:Laparotomywiththeplacementofanytemporary
abdominalclosuredoes noteliminatethepossibilityofelevationinintra-abdominalpressure
(IAP).WhenusingNegativePressureTherapy,IAPmonitoring(forclinicalordiagnosticsignsand
symptomsofelevatedIAP)shouldcontinueasindicatedbypatientconditionandinaccordance
withinstitutionalclinicalpracticeorguidelines.Ifintra-abdominalhypertension(IAH)orabdominal
compartmentsyndrome(ACS)isobservedorsuspected,noteintra-abdominalpressuresand
turnoffpowertotheNegativePressureTherapyUnit,discontinuingnegativepressure.Afterfull
expansionoftheperforatedfoam,obtainanewintra-abdominalpressuremeasurement.IfIAH
/ACSpersistswithoutnegativepressure,discontinuetheuseofNegativePressureTherapyand
addresstheunderlyingconditionasmedicallyindicated.
• Multiplelayersofthedrapemaydecreasethemoisturevaportransmissionrate,whichmay
1. RemovecontentsfrominnerpouchandunfoldtheVisceralProtectiveLayerinasterilefield.
EithersideoftheVisceralProtectiveLayermaybeplacedontheomentumorviscera.
2. GentlyplaceVisceralProtectiveLayerovertheopenabdominalcavity(Fig. 1).
3. Determinetheorientationofthedressingforthespecificapplication.IfVisceralProtective
Layerwillbeplacedaroundtubes,drainsorthefalciformligament,cutonlybetweenthefoam
extensions(Fig. 2).Donotcutnearorthroughfoamextensions.OrienttheVisceralProtective
Layeraccordinglybeforecutting.
4. SizetheVisceralProtectiveLayerbyfoldingorcuttingasdescribedinthefollowingsections.
Folding Visceral Protective Layer to Size
Fig. 3
discontinueuseandconsultaphysician.
Dressing Removal:Thedressingcomponentsarenotbioabsorbable.Alwaysremovealldressing
componentsfromtheabdomenateverydressingchange.
duringdrapeapplication.
DRESSING APPLICATION
Cutting Visceral Protective Layer to Size
Perforated
Foam(2)
VisceralProtective
Layer(1)
SensaT.R.A.C.™
Pad(1)
Fig. 4
1. Holddressingbytheedgeandslightlylift.Slowlylowerdressingintotheparacolicgutter,using
theotherhandtogentlyandevenlyworkthedressingdown(Fig. 3).FoldanyexcessVisceral
ProtectiveLayerupandoverontoitself.
2. ContinueplacingVisceralProtectiveLayerbetweenabdominalwallandinternalorgans(Fig. 4)
throughouttheabdominalcompartment.Thegoalistoensurefullcoverageofallviscera.
ABThera™ SensaT.R.A.C.™ OPEN ABDOMEN DRESSING COMPONENTS
Defibrillation:Removeadhesivedrapefromareaofdefibrillationtopreventinhibitionofelectrical
energytransmission.
Application Setting:Dressingapplicationsandchangesshouldbeperformedunderstrictsterile
conditionsinthesurgicalsuite.Ifdressingchangeisperformedoutsidethesurgicalsuite,itmust
beperformedinanenvironmentequippedtoaddresstheonsetofcriticalcomplications(referto
WARNINGSsection)andwherestrictaseptictechniquecanbeutilized.
Fig. 2
• Ifanysignsofirritationorsensitivitytothedrape,foamorSensaT.R.A.C.™Padtubingappear,
IfthereareanyquestionsregardingtheproperplacementorusageoftheABThera™SensaT.R.A.C.™
OpenAbdomenDressing,pleasecontactyourlocalKCIclinicalrepresentative.
Hyperbaric Oxygen Therapy (HBO):DonottaketheNegativePressureTherapyUnitinto
ahyperbaricoxygenchamber.TheNegativePressureTherapyUnitisnotdesignedforthis
environment,andshouldbeconsideredafirehazard.AfterdisconnectingtheNegativePressure
TherapyUnit,either(i)replacethedressingwithanotherHBOcompatiblematerialduringthe
hyperbarictreatmentor(ii)covertheunclampedendoftheSensaT.R.A.C.™Padtubingwithmoist
cottongauze.ForHBOtherapy,thetubingmustnotbeclamped.Neverleaveadressinginplace
withoutactivenegativepressureformorethantwohours;pleaserefertotheKeep Negative
Pressure Onsection.
Fig. 1
increasetheriskofmaceration.
• Toavoidtraumatotheperiwoundskin,donotpullorstretchthedrapeoverthefoamdressing
Bleeding:Patients with abdominal wounds must be closely monitored for bleeding as
these wounds may contain hidden blood vessels which may not be readily apparent. If
sudden or increased bleeding is observed in the dressing, tubing or canister, immediately
discontinue Negative Pressure Therapy, take appropriate measures to stop bleeding, and
contact the physician. Negative Pressure Therapy is not designed to prevent, minimize or
stop bleeding.
• Radiation
Enteric Fistula or Leak:Whentreatinganopenabdomenwhereentericfistulasarepresent,
cliniciansshouldconsiderthepotentialforabdominalcontaminationifeffluentisnotappropriately
isolatedormanaged.
Dressing Placement:Alwaysuseadressingfromasterilepackagethathasnotbeenopenedor
damaged.Donotforceanydressingcomponentintothewound,asthismaydamageunderlying
tissue.
Magnetic Resonance Imaging (MRI) – ABThera™ SensaT.R.A.C.™ Open Abdomen Dressing:
ThedressingcanremainonthepatientwithminimalriskinanMRenvironment,assumingthat
useofNegativePressureTherapyisnotinterruptedformorethantwohours;pleaserefertoKeep
Negative Pressure On section.
• Trauma
Spinal Cord Injury:Intheeventapatientexperiencesautonomicdysreflexia(suddenchanges
inbloodpressureorheartrateinresponsetostimulationofthesympatheticnervoussystem),
discontinueNegativePressureT0herapytohelpminimizesensorystimulation.
Infection:Infectedabdominalwoundsshouldbemonitoredcloselyandmayrequiremore
frequentdressingchangesthannon-infectedwounds,dependentuponfactorssuchaspatient
condition,woundconditionandtreatmentgoals.Refertodressingapplicationinstructionsfor
detailsregardingdressingchangefrequency.
Acrylic Adhesive:Thedrapehasanacrylicadhesivecoating,whichmaypresentariskofadverse
reactioninpatientswhoareallergicorhypersensitivetoacrylicadhesives.Ifapatienthasaknown
allergyorhypersensitivitytosuchadhesives,donotusethedressing.Ifanysignsofallergic
reactionorhypersensitivitydevelop,suchasredness,swelling,rash,urticariaorsignificantpruritus,
discontinueuseandensureappropriateemergencymedicaltreatment.Ifbronchospasmormore
serioussignsofallergicreactionappear,removedressingandensureappropriateemergency
medicalinterventionasindicated.
WARNING: The foam in the Visceral Protective Layer is encapsulated for patient safety.
Protect vital structures with Visceral Protective Layer at all times during therapy. Never
place exposed foam material directly in contact with exposed bowel, organs, blood
vessels or nerves.
Patient Size and Weight:Thesizeandweightofthepatientshouldbeconsideredwhen
prescribingNegativePressureTherapy.Initiallowernegativepressureshouldbeconsideredfor
certainsmallorelderlypatientswhoareatriskoffluiddepletionordehydration.Monitorfluid
outputincludingthevolumeofexudateinboththetubingandcanister.Thistherapyhasthe
potentialtoremoveandcollectlargevolumesoffluid.Tubingvolume=approximately25mLfrom
SensaT.R.A.C.™Padtocanister.
Protect Periwound Skin:Consideruseofaskinpreparationproducttoprotectperiwoundskin.
Donotallowfoamtooverlapontointactskin.Protectfragile/friableperiwoundskinwithadditional
drape,hydrocolloidorothertransparentfilm.
Keep Negative Pressure On:Neverleavethedressinginplacewithoutactivenegativepressure
formorethantwohours.Ifnegativepressureisoffformorethantwohours,changedressingas
showninthedressingapplicationinstructions.Eitherapplyanewdressingfromanunopened
sterilepackageandrestartnegativepressure,orapplyanalternativedressing.
TheVisceralProtectiveLayerisfenestratedtoallowforactivefluidremovalwhennegativepressure
isappliedandisdesignedtoallowapplicationofthislayerdirectlyoveromentumorexposed
internalorgans.
Monitor Fluid Output:Thedressingisdesignedtoefficientlyremovefluidfromtheabdominal
compartmentandtoevenlydistributenegativepressure.WhentreatingpatientswithNegative
PressureTherapy,thevolumeofexudateinthecanisterandtubingshouldbefrequentlyexamined.
Adhesions and Fistula Development:Formationofadhesionsofthevisceratotheabdominal
wallmayreducethelikelihoodoffascialreapproximationandincreasetheriskoffistula
developmentwhichisacommoncomplicationinpatientswithexposedviscera.
• Instillationofunwarmedfluidinlargequantitiesmayleadtohypothermia.
• Suturingand/oranastomoses
Intra-abdominal Packing:Whenusingintra-abdominalpackingwithNegativePressureTherapy,
packingmaterialmaybedrierthananticipated.Evaluatepackingmaterialpriortoremovaland
rehydrateifnecessarytopreventadherenceordamagetoadjacentstructures.
Bradycardia:Tominimizetheriskofbradycardia,thedressingmustnotbeplacedinproximityto
thevagusnerve.
Only Use the SensaT.R.A.C.™ Pad:Substitutionwithanyothertubing,alterationofthe
SensaT.R.A.C.™PadorbreachoftheprescribedSensaT.R.A.C.™Padapplicationforthepurposeof
instillingfluidsintotheopenabdomenisnotrecommendedunderanycircumstance.Thismay
leadtolossofsystemefficacyorharmtothepatient.
Thefollowingconditionsmayincreasetheriskofpotentiallyfatalbleeding.
VISCERAL PROTECTIVE LAyER APPLICATION
Standard Precautions:Toreducetheriskoftransmissionofbloodbornepathogens,apply
standardprecautionsforinfectioncontrolwithallpatients,perinstitutionalprotocol,regardless
oftheirdiagnosisorpresumedinfectionstatus.Inadditiontogloves,usegownandgogglesif
exposuretobodyfluidsislikely.
Use of Visceral Protective Layer:WhenusingNegativePressureTherapy,ensurethattheVisceral
ProtectiveLayercompletelycoversallexposedvisceraandcompletelyseparatestheviscerafrom
contactwiththeabdominalwall.PlacetheVisceralProtectiveLayerovertheomentumorexposed
internalorgans,andcarefullytuckitbetweentheabdominalwallandinternalorgans,makingsure
theVisceralProtectiveLayercompletelyseparatestheabdominalwallfromtheinternalorgans.
Magnetic Resonance Imaging (MRI) – Therapy Unit:TheNegativePressureTherapyUnitisMR
unsafe.DonottakethedeviceintotheMRenvironment.
Hemostasis must be achieved prior to dressing placement.
PRECAUTIONS
• Inadequatewoundhemostasis
Drape(4)
WOUND PREPARATION
WARNING: Review all ABThera™ SensaT.R.A.C.™ Open Abdomen Dressing Safety
Information before beginning wound preparation. Ensure adequate hemostasis has been
achieved prior to dressing placement (refer to Bleeding section under WARNINGS).
1. Sharpedgesorbonefragmentsmustbeeliminatedfromwoundareaorcovered(referto
BleedingsectionunderWARNINGS).
2. Irrigateabdominalwoundandcleanseperiwoundskinasindicated.
3. Cleananddryperiwoundtissue;consideruseofaskinpreparationproducttoprotect
periwoundskin.Donotallowfoamtooverlapontointactskin.Protectfragile/friable
periwoundskinwithadditionaldrape,hydrocolloidorothertransparentfilm.
Fig. 5
A
B
C
1. CutVisceralProtectiveLayerawayfromwound,throughcenteroflargefoamsquaresusing
sterilescissors(Fig 5A).Donotcutthroughnarrowconnectingtabsbetweenthelargefoam
squares.
2. Pinchtheremaininghalfofthefoamsquareanditsconnectingtabandpull.Thefoamandtab
willseparateatthenextsquare(Fig. 5B).ThiswillensurethatedgesofVisceralProtectiveLayer
coverexposedfoamedge(Fig. 5C)andfoamcannotcontactorgans(seeWARNINGabove).
3. Documentnumberoffoamextensionsremovedandthateachpiecehasbeenproperly
disposedofawayfromwoundcavity.
CAUTION: Do not tear the foam over the wound, as fragments may fall into the wound. Rub or trim
foam away from wound, removing any fragments to ensure loose particles will not fall into or be left
in the wound upon dressing removal.
PERFORATED FOAM APPLICATION
SENSAT.R.A.C.™ PAD APPLICATION
Fig. 16
1
1
1
4. Initiatetherapy.Assessdressingtoensureintegrityofseal.Thedressingshouldcollapseand
haveawrinkledappearance.Thereshouldbenohissingsounds.Ifthereisanyevidenceofnonintegrity,checkdrapeandSensaT.R.A.C.™Padseals,tubingconnections,andcanisterinsertion,
andensureclampsareopen.Secureexcesstubingtopreventinadvertenttensionontubing,
whichmaydisrupttheseal.
1
1
1
2
2
2
2
1
Fig. 6
Fig. 7
Fig. 8
Fig. 14
Bleeding: Patients with abdominal wounds must be closely monitored for bleeding as
these wounds may contain hidden blood vessels which may not be readily apparent. If
sudden or increased bleeding is observed in the dressing, tubing or canister, immediately
discontinue Negative Pressure Therapy, take appropriate measures to stop bleeding, and
contact the physician. Negative Pressure Therapy is not designed to prevent, minimize or
stop bleeding. (Refer to WARNINGS, Bleeding section).
Fig. 15
Fig. 17
Theperforatedfoam(Fig. 6)providedwiththeABThera™SensaT.R.A.C.™OpenAbdomenDressing
isintendedto:
Monitor Fluid Output - Thedressingisdesignedtoefficientlyremovefluidfromtheabdominal
compartmentandtoevenlydistributenegativepressure.WhentreatingpatientswiththeNegative
PressureTherapyUnit,thevolumeofexudateinthecanisterandtubingshouldbefrequently
examined
• TransfernegativepressurefromtheNegativePressureTherapyUnittotheVisceralProtective
Layertopromoteactivefluidremoval.
• Providemedialtensionuponfoamcollapsetohelpmaintainfascialdomain.
1. Tearorcutperforatedfoamtoneededsizeasshownbelow(Fig. 7).Thefoamshouldfit
directlyovertheVisceralProtectiveLayerandbeincontactwithwoundedges.Donotallow
foamtocontactintactskin.Oneorbothpiecesoftheprovidedperforatedfoamcanbeused,
dependingonthewoundprofile.
2. GentlyplaceperforatedfoamintowoundcavityovertheVisceralProtectiveLayer(Fig. 8).
Ensurethatperforatedfoamdoesnotgobelowtheleveloftheabdominalincisionorwound.
Donotforcefoamintoanyareaofthewound.
ALARM RESOLUTIONS
Alltherapyunitalarmsshouldbeaddressedinatimelymanner.Refertothetherapyunituser
manualforcompleteinformationonalarmresolutions.
NOTE: Do not cut off the pad or insert the tubing into the foam dressing. This may occlude the tubing
and cause the Negative Pressure Therapy Unit to alarm and could injure underlying viscera.
NOTE: Ensure foam-to-foam contact for even distribution of negative pressure.
1. Choosepadapplicationsite.Giveparticularconsiderationtofluidflowandtubingpositionto
allowforoptimalflowandavoidplacementoverbonyprotuberancesorwithincreasesinthe
tissue.
NOTE: Always note the total number of pieces of foam used and document on the drape and in the
patient’s chart.
2. Pinchdrapeandcuta2.5 cmhole(notaslit)throughthedrape(Fig. 14).Itisnotnecessaryto
cutintothefoam.
NOTE: Cut a hole rather than a slit, as a slit may self-seal during therapy.
DRAPE APPLICATION
Fig. 9
Fig. 10
3. Applypad,whichhasacentraldiscandasurroundingouteradhesiveskirt.
Fig. 11
• Gentlyremovebothbackinglayers1and2toexposeadhesive(Fig. 15).
• Placepadopeningincentraldiscdirectlyoverholeindrape(Fig.16).
Incaseofaleakalarm,patchleaksourcewithadditionaldrapetoensureintegrityofseal.
CAUTION: Due to the highly exudative nature of abdominal wounds, Negative Pressure Therapy should
be interrupted only for wound care and dressing change. Interruption of therapy can result in loss of seal
integrity.
DRESSING CHANGES
Dressingchangesshouldoccurevery24to72hours,ormorefrequentlybaseduponacontinuing
evaluationofwoundconditionandpatientpresentation.Considermorefrequentdressingchanges
inthepresenceofinfectionorabdominalcontamination.
Wheneverthedressingischanged,alwaysreplacealldressingcomponentswithcomponentsfrom
anunopenedsterilepackage.
2
• Applygentlepressureonthecentraldiscandouterskirttoensurecompleteadhesionof
1
2
1
2
1
1
2
DRESSING REMOVAL
1
2
1
1
4. Pullbackonbluetabtoremovepadstabilizationlayer(Fig. 17).Dressingapplicationis
complete.
2
1
1
2
1
2
2
1
2
1
2
V.A.C.® NEGATIVE PRESSURE THERAPy APPLICATION
Fig. 12
KaplanM.Managingtheopenabdomen.OstomyWoundManagement,2004Jan;50(1Asuppl);C2,
1-8
KaplanM,BanwellP,OrgillDP,IvaturyRR,DemetriadesD,MooreFA,MillerP,NicholasJ,HenryS,
GuidelinesfortheManagementoftheOpenAbdomen.WOUNDS.2005Oct;17(Suppl1);S1S24
GarnerGB,WareDN,CocanourCS,DukeJH,McKinleyBA,KozarRA,MooreFA.Vacuum-assisted
woundclosureprovidesearlyfascialreapproximationintraumapatientswithopenabdomens.The
AmericanJournalofSurgery,2001Dec;182(6);630-8
BarkerDE,KaufmanHJ;VacuumPackTechniqueofTemporaryAbdominalClosure;A7-Year
Experiencewith112Patients.Presentedatthe59thAnnualMeetingoftheAmericanAssociationfor
theSurgeryofTrauma.September16-18,1999.BostonMass.
BrockWB,BarkerDE;TemporaryClosureofOpenAbdominalWounds;TheVacuumPack.Presented
atthe66thAnnualScientificMeetingoftheSoutheasternCongress,LakeBuenaVista,Florida.
February6-10,1994
SherckJ,SeiverA;Coveringthe“OpenAbdomen”;ABetterTechnique.PresentedasaPosterat
the66thAnnualScientificMeetingandthePostgraduateCourseProgram.SoutheasternSurgical
Congress.Atlanta,Georgia.January31-February4,1998.
CONTACT INFORMATION
Forquestionsregardingthisproduct,maintenance,oradditionalinformationaboutKCIproducts
andservices,pleasecontactKCIoraKCIauthorizedrepresentative,or:
IntheUScall1-800-275-4524orvisitwww.kci1.comorwww.openabdomen.com.
OutsidetheUSvisitwww.kci-medical.com.
MANUFACTURER INFORMATION
RefertoApplication SettingsectionunderWARNINGS.
thepad.
REFERENCE LIST
Referencesavailableonrequest.PleasecontactKCIat1-800-275-4524(intheUS).
Remove and discard previous dressing per institution protocol. Completely inspect wound,
includingparacolicgutters,toensureallpiecesofdressingcomponentshavebeenremoved.
Ifintra-abdominalpackingispresent,packingmaterialmaybedrierthananticipated.Evaluate
packingmaterialpriortoremovalandrehydrateifnecessarytopreventadherenceordamageto
adjacentstructures.
0473
KCI USA, Inc.
San Antonio, TX 78219 USA
1-800-275-4524
www.kci1.com
EC REP
KCI Medical Products (UK), Ltd.
Wimborne, Dorset
BH21 7SH
United Kingdom
www.kci-medical.com
WARNING: Refer to Dressing Removal section under WARNINGS.
EXPLANATION OF SyMBOLS USED
Donotuseifpackageis
damagedoropen
Fig. 13
Fig. 18
Manufacturer
Singleuseonly
DateofManufacture
1. Holdingthedrape,partiallypullbackonesideoflayer1toexposeadhesive(Fig. 9).Besureto
holdlayer1flapback,topreventre-adherencetodrape.
NOTE: Only for use with Negative Pressure Therapy provided by InfoV.A.C.®, V.A.C.® ATS and V.A.C.Ulta™
Negative Pressure Therapy Units. Refer to the therapy unit user manual for complete instructions for use.
2. Placethedrapeadhesive-sidedowntocoverfoamandintactskin,ensuringdrapecoversat
leastan8-10cmborderofintactperiwoundtissue(Fig. 10).Useanyexcessdrapetoseal
difficultareas,ifneeded.
NOTE: SensaT.R.A.C.™ Pad tubing is not compatible with hospital vacuum systems.
NOTE: To avoid trauma to the periwound skin, do not pull or stretch the drape over the
foam dressing. Minimize wrinkles, as they may be a source of negative pressure leaks (refer to
PRECAUTIONS, Protect Periwound Skin section).
3. Removeremainingtab1backingmaterialandpatarounddrapetoensureanocclusiveseal.
WARNING: Review all Negative Pressure Therapy System Safety Information before
initiating therapy.
1. Removecanisterfrompackagingandinsertintothetherapyunituntilitlocksintoplace.
n
4. Removegreen-stripedstabilizationlayer2(Fig. 11).
5. Removeperforatedbluehandlingtabsfromdrape(Fig. 12).
NOTE: If the canister is not fully engaged, the therapy unit will alarm.
ContainsPhthalates
AuthorizedRepresentativein
theEuropeanCommunity
Methodofsterilization-
Radiation
Useby
2. ConnectSensaT.R.A.C.™Padtubingtocanistertubingandensureclamponeachtubeisopen
(Fig. 18).Positionclampsawayfrompatient.
3. Turnonpowertothetherapyunitandselect125mmHg,continuousmodetherapysetting
forefficientfluidremovalrates.Negativepressuretherapysettingsbelow125mmHgarenot
recommended.
Contentinformation
Each
NOTE: Abdominal wounds often have copious drainage. Consider using the 1000 cc / mL canister.
Ensure an adequate supply of canisters is readily available.
CAUTION: Consider the size and the weight of the patient, patient condition, wound type,
monitoring capability and care setting when using the 1000 cc / ml canister.
NOTE: When using multiple pieces of drape, ensure that the edges of the drape overlap in order to
achieve a seal (Fig. 13).
Consultinstructionsforuse
ConformswiththeMedicalDevice
Directive(93/42/EEC)andhasbeen
subjecttotheconformityprocedures
laiddowninthecouncildirective.
CAUTION:Federal(US)lawrestricts
Keepdry
thisdevicetosale/rentalbyoron
theorderofaphysician.
CAUTION: Do not use intermittent therapy / Dynamic Pressure Control (DPC) with the ABThera™
SensaT.R.A.C.™ Open Abdomen Dressing.
AlltrademarksdesignatedhereinarepropertyofKCILicensing,Inc.,itsaffiliates,and/orlicensors.
©2013KCILicensing,Inc.AllRightsReserved.370553RevD1/2013