Delfi PTS ii Installation instructions

OPERATORANDMAINTENANCEMANUAL
DELFIPTSiiPORTABLETOURNIQUETSYSTEM
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REF9‐2200‐001X
U.S.PATENTS6,213,939;5,931,853;5,649,954PAT.PEND.andFOREIGNPATENTS
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Delfi
medical
innovations inc.
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DelfiMedicalInnovationsInc.
VancouverBC,Canada
800‐933‐3022(US&Canada)
604‐742‐0600(Global)
Fax.604‐742‐3800
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www.delfimedical.com
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LIMITEDTWOYEARWARRANTY(NorthAmerica.only)
SCOPEOFWARRANTY
DelfiMedicalInnovationsInc.(‘Delfi’)warrantsthePTSiiPortableTourniquetSystem(‘product’)fortwoyearsfrom
dateofpurchase.Duringthewarrantyperiod,Delfiwillrepairorreplace,atitsoption,anyproductwhichisdefectivein
materialsorworkmanshiporwhichfailstomeetthepublishedspecificationforthatmodel.ThisLimitedWarrantyis
madeonlytotheoriginalpurchaseroftheproductandisnon‐transferable.TheremediesdescribedintheLimited
Warrantyaretheexclusiveremediesforbreachofwarranty.THISWARRANTYSHALLNOTAPPLYTOANYPRODUCT
WHICHHASBEENALTERED,MODIFIED,DISASSEMBLEDORSERVICEDBYANYONEOTHERTHANDELFISTAFFINANY
WAY,ORWHICHHASBEENSUBJECTEDTOMISUSEORABUSE.
DISCLAIMEROFIMPLIEDWARRANTIES
TheforegoingExpressLimitedWarrantyisgiveninlieuofanyandallotherexpressorimpliedwarranties.DELFIMAKES
NOOTHERWARRANTIESINCLUDINGTHEIMPLIEDWARRANTIESOFMERCHANTABILITYORFITNESSFORAPARTICULAR
PURPOSE.
LIMITATIONOFREMEDIES
InnocaseshallDelfiMedicalInnovationsInc.beliableforanyspecialincidentalorconsequentialdamageswhether
basedonbreachofwarrantyorotherlegaltheory.Somestatesdonotallowlimitationsonwarrantiesoronremedies
forbreachincertaintransactions.Insuchstates,thelimitsinthisparagraphandtheprecedingparagraphdonotapply.
WARRANTYCLAIMS
Intheeventofawarrantyclaimwithinthewarrantyperiodpleasetakethefollowingsteps:
1.NotifyCustomerServiceDepartment,DelfiMedicalInnovationsInc.at800‐933‐3022.Pleaseprovidedetailsabout
thenatureoftheproblemandincludetheproductserialnumber.Uponreceiptofthisinformation,Delfiwillprovidea
dateforserviceorareturnshippingauthorization.
2.Uponreceiptoftheshippingauthorization,forwardtheequipment,freightprepaid,tothelocationspecifiedinthe
shippingauthorization.
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Yourcompliancewiththesestepswillhelpassurethatyoureceivepromptwarrantyserviceforyourproduct.
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WARRANTY(OUTSIDENorthAmerica)
PleasecontactDelfiforwarrantyinformation.
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UnitSerialNumber_________________
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ACPowerSupplySerialNumber_________________
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2
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TABLEOFCONTENTS
DelfiPTSiiTOURNIQUETSYSTEM
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SECTIONTITLEPAGE
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SECTION1.0GENERALINFORMATION ............................................................................................ 3
1.1SPECIFICATIONS..................................................................................................................3
1.2INTENDEDUSE.................................................................................................................... 4
1.3CONTRAINDICATIONS......................................................................................................... 4
1.4PRECAUTIONSINUSE ......................................................................................................... 4
1.5ADVERSEEFFECTS............................................................................................................... 5
SECTION2.0INSTALLATIONANDOPERATINGINSTRUCTIONS ......................................................... 6
2.1INITIALINSPECTION............................................................................................................ 6
2.2CONTROLS,INDICATORS,LCDDISPLAY,ANDCONNECTORS ............................................. 6
2.3INITIALSETUP ................................................................................................................... 10
2.4FUNCTIONALANDCALIBRATIONCHECK .......................................................................... 10
2.5PRESSURESETPOINTADJUSTMENT ................................................................................ 12
2.6TIMELIMITSETPOINTADJUSTMENT............................................................................... 12
2.7TOURNIQUETTIMERESET................................................................................................ 13
2.8SETUP/SPECIALFEATURES.............................................................................................. 13
2.9LEAKTEST ......................................................................................................................... 13
2.10SETDEFAULTPRESSURE ................................................................................................... 14
2.11SETDEFAULTTIMELIMIT ................................................................................................. 14
2.12PRINTERLABELSIZE.......................................................................................................... 15
2.13ALARMVOLUME............................................................................................................... 15
2.14LANGUAGE ....................................................................................................................... 15
2.15PRINTER ............................................................................................................................ 15
2.16OPERATION.......................................................................................................................16
2.17ALARMCONDITIONS ........................................................................................................ 18
SECTION3.0MAINTENANCEINSTRUCTIONS ................................................................................. 23
3.1GENERALMAINTENANCEINFORMATION ....................................................................... 23
3.2PERIODICMAINTENANCE................................................................................................. 24
3.3CALIBRATION.................................................................................................................... 24
3.4LEAKTESTING ................................................................................................................... 24
3.5BATTERYTESTINGANDREPLACEMENT............................................................................ 25
3.6INTERNALHARDWARESERVICING ................................................................................... 26
3.7TROUBLESHOOTINGGUIDE.............................................................................................. 26
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FIGURESandTABLES:
Figure2.1:PTSiiControls,Indicators,Displays,andConnectors ..................................................................8
Figure2.2:PTSiiSinglesystemmountingbracket(7‐2200‐008)...................................................................9
Figure2.3:PTSiiTwinsystemmountingbracket(7‐2200‐009)........................................................................... 9
Table2.1:AlarmsandWarnings ....................................................................................................................... 19
Table3.1: Troubleshooting ............................................................................................................................... 26
Figure3.1:Labels................................................................................................................................................ 28

3
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GENERALINFORMATION
SECTION1.0
DELFIPTSiiTOURNIQUETSYSTEM
1.1SPECIFICATIONS
REF9‐2200‐001B–BlueFrontPanel
REF9‐2200‐001R–RedFrontPanel
ACPowerAdaptor:
UseonlysuppliedACadapter/powercordassemblyDelfi
REF7‐2200‐020(SingleOutput)or
REF7‐2200‐021(DualOutput)
MainsLineVoltageRange:
100‐240~(AC),50/60Hz.Autoswitching
Linecurrent:
175mARMS@120V~(AC)Typical
(REF7‐2200‐020SingleOutput)
300mARMS@120V~(AC)Typical
(REF7‐2200‐021DualOutput)
InputPower:
100wattsmaximumREF7‐2200‐020
100wattsmaximumREF7‐2200‐021
ACPowerplug:(NorthAmerica)
Hospitalgrade,3prongstraightblade,15amp
BatteryType:
12Vnickel‐metal‐hydride(NiMh)internallyprotected
pack,2200milliamphours
UseonlyDelfiREF7‐2200‐007batterypack
BatteryRechargeTime:
10.0hours(typical)
CuffPressureRange:
50‐600mmHg,5mmHgincrements
PressureAccuracy:
+/‐2mmHg
PressureRegulation:
+/‐6mmHgofsetpoint(10‐secondaverageundernon
transientconditionswithoutexternalleaks)
TimeAlarmSetPointRange:
0‐240minutes,5minuteincrements
TimerAccuracy:
0.1%ofelapsedtime
InflationRate:
34inchcuffappliedtoa30inchthighinflatesto350
mmHginlessthan5seconds
DeflationRate:
34inchcuffappliedtoa30inchthighdeflatestoless
than10mmHginlessthan10seconds
InternalDiagnostics:
Program,memory,watchdogtimer,transducer
calibration,impropervalveactuation.
Display:
Color240x320LCDBacklit
Indicators:
ACIndicatorLight–Green
AlarmIndicatorLight‐Red
Controls:
Sevenbuttonslocatedonthefrontpanel
PrinterInterface:
RS2329600Baud
Size:
Height:180mm(7.0inches)
Width:120mm(4.7inches)
Depth:110mm(4.3inches)
Weight1.08kg(38.0oz)
Environmental:
Operatingtemperature:10to40°C(15to105°F)
Storagetemperature:‐20to40°C(‐4to105°F)
Humidity:Max80%non‐condensing
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Thisdeviceisnotsuitableforuseinthepresenceof
flammableanestheticorgases
ElectromagenticCompatability(EMC):
Thismedicalelectricalequipmentneedsspecial
precautionsregardingEMCandneedstobeinstalledand
putintoserviceaccordingtotheEMCinformation
providedbelow.
PortableandmobileRFcommunicationsequipmentcan
affectmedicalelectricalequipment.
Guidance and manufacturer's declaration - electromagnetic emissions
The PTS ii tourniquet system is intended for use in the electromagnetic environment
specified below. The user of the PTS ii tourniquet system should assure that is used in
such an environment.
Emissions Test Compliance Electromagnetic environment guidance
RF emissions
CISPIR 11 Group 1 The PTS ii tourniquet system uses RF energy
only for its internal function. Therefore only its
RF emissions are very low and not likely to
cause interference in nearby electronic
equipment.
RF emissions
CISPIR 11 Class A
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3 Complies
The PTS ii system is suitable for use in all
establishments other than those directly
connected to the public low voltage power
supply network that supplies buildings used for
domestic purposes.
AdditionalEMCcompatibilityinformationavailableatwww.delfimedical.com

4
NOTE:Usethistourniquetsystemaccordingtothe
policiesinyourpracticesetting.Thefollowing
informationonintendeduse,precautions,
contraindications,andadverseeffectsare
offeredasaguidetoassistinthisprocess.
1.2INTENDEDUSE
TheDelfiPTSiiPortableTourniquetSystemisintendedto
beusedbyqualifiedmedicalprofessionalstotemporarily
occludebloodflowinapatient'sextremityduringsurgical
proceduresonthatextremity.Tourniquetsaregenerally
usedforoperationslastinglessthan90minutes.
Tourniquetshavebeenfoundusefulinproducinga
bloodlessoperationfieldinsurgicalproceduresinvolving
theextremitiesincluding:
Reductionofcertainfractures
Kirschnerwireremoval
Tumorandcystexcisions
Kneejointreplacements
Arthroscopyofcertainjoints
Replacementoffingerjoints
Bonegrafts
Amputations
Subcutaneousfasciotomy
Nerveinjuries
Tendonrepair
Totalwristjointreplacement
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WARNING:Donotusetourniquetcuffstocontrolthe
distalflowofCO2oranyothergasesusedasadistention
media.Tourniquetcuffshavenotbeenevaluatedfor
safetyoreffectivenessincontrollinggasflowbeyondthe
surgicalsiteduringarthroscopicinsufflationprocedures.
Possibleeffectsofusingatourniquetcuffinthismanner
includeserioussubcutaneousemphysemaproximalto
thecuff.
1.3CONTRAINDICATIONS
Refertothemedicalliteratureforpossiblecontra‐
indicationstotourniquetuse.Apartiallistisprovided
below,howeverineverycasethefinaldecisiontousea
tourniquetrestswiththeattendingphysician.
Openfracturesoftheleg
Post‐traumaticlengthyhandreconstruction
Severecrushinginjuries
Diabetesmellitus
Severehypertension
Elbowsurgery(wherethereisconcomitantexcess
swelling)
Skingraftsinwhichallbleedingpointsmustbe
readilydistinguished
Compromisedvascularcirculation,e.g.,peripheral
arterydisease
Sicklecelldiseaseortrait(relativecontraindication,
seePRECAUTIONSINUSE).
Secondaryordelayedproceduresafter
immobilization.
1.4PRECAUTIONSINUSE
Thetourniquetsystemmustbekeptwellcalibrated
andinoperablecondition.Accessoriesshouldbe
checkedregularlyforleaksandotherdefects.
Thetourniquetcuffmustneverbepunctured;
thereforetowelclipsusednearthesystemmustbe
handledwithspecialcare.
Cuffswithinnerrubberbladdersmustbecompletely
enclosedbytheouterenvelopetopreclude
ballooningandpossibleruptureofthebladder.
Cleaningandassemblyinstructionsofthecuff
manufacturershouldbefollowedcarefully.
Donotuseanelasticbandageforexsanguinationin
caseswherethiswillcausebacteria,exotoxins,or
malignantcellstospreadtothegeneralcirculation,or
whereitcoulddislodgethromboembolithatmay
haveformedinthevessels.
Thetourniquetcuffmustbeappliedintheproper
locationonthelimb.Tourniquetpressureandthe
timethetourniquetisinflatedonthelimbshould
bothbeminimized.Thereisadditionalpotentialrisk
tosuperficialnervesinunprotectedareas;never
applyatourniquetoveranareawheremajornerves
maybedirectlycompressedagainstbone(eg.
peronealnerveneartheproximalheadofthefibula).
Neverapplyatourniquetoverthejointsofthelimb.
Donotreadjustanalreadyinflatedcuffbyrotatingit
becausethisproducesshearingforceswhichmay
damagetheunderlyingtissue.Prolongedischemia
mayleadtotemporaryorpermanentdamageto
tissues,bloodvessels,andnerves.
Prolongedtourniquettimecanalsoproducechanges
inthecoagulabilityofthebloodwithincreased
clottingtime.Alwaysminimizetourniquettime
Tourniquetparalysismayresultfromexcessive
pressure.Insufficientpressuremayresultinpassive
congestionofthelimbwithpossibleirreversible
functionalloss.Alwaysusetheminimumeffective
tourniquetpressure,asdescribedinthemedical
literature.
Inflationshouldbedonerapidlytooccludearteries
andveinsasnearsimultaneouslyaspossible.
Carefulandcompleteexsanguinationreportedly
prolongspain‐freetourniquettimeandimprovesthe
qualityofIntravenousRegionalAnesthesia(BierBlock
anesthesia).Inthepresenceofinfectionandpainful
fractures,afterthepatienthasbeeninacast,andin
amputationsduetomalignanttumors,exsan‐

5
guinationbeforetourniquetapplicationmaybedone
withouttheuseofanelasticbandagebyelevating
thelimbfor3to5minutes.
Incaseoffailure,thetourniquetcuffmustbefully
deflatedandthelimbexsanguinatedagainbefore
reinflation.Reinflationoverblood‐filledvasculature
mayleadtointravascularthrombosis.
Tourniquetusersmustbefamiliarwiththeinflation/
deflationsequencewhenusingtwotourniquetcuffs
andtwoPTSiiunitstogetherforIVRA(BierBlock
anesthesia),sothatthewrongtourniquetwillnotbe
releasedaccidentally.
Testforhemoglobintypeandlevelbeforeusinga
tourniquetonpatientswithsickle‐cellanemia.When
thetourniquetisusedforthesepatients,thelimb
shouldbecarefullyexsanguinatedandthePO2and
pHshouldbecloselymonitored.
Selectthepropercuffsizetoallowfortheoverlap
recommendedbythecuffmanufacturer.Toomuch
ortoolittleoverlapmaycausecuffrollingand
telescoping,unexpectedreleaseofthecufffromthe
limb,inabilitytomaintainabloodlessfieldatnormal
pressures,and/orundesiredpressuredistributionon
thelimb.
Theskinunderthetourniquetcuffmustbeprotected
frommechanicalinjurybysmooth,wrinkle‐free
applicationofthecuff.Ifthetourniquetcuffis
appliedoveranymaterialthatmayshedloosefibers
(suchasWebril)thefibersmaybecomeembeddedin
thecontactclosuresandreducetheireffectiveness.
Followthecuffmanufacturer’srecommendationsfor
limbprotectionmaterialunderthecuff.Ingeneral,a
limbprotectionsleevedesignedspecificallyforthe
cuffprovidesthebestprotection.
Ifskinpreparationsareusedpreoperatively,they
shouldnotbeallowedtoflownorcollectunderthe
cuffwheretheymaycausechemicalburns.
Wheneverthetourniquetcuffpressureisreleased,
thewoundshouldbeprotectedfrombloodsurging
backbyapplyingpressuredressingsand,ifnecessary,
elevatingthelimb.Transientpainupontourniquet
pressurereleasecanbelessenedbyelevationofthe
limb.Iffullcolordoesnotreturnwithin3to4
minutesafterrelease,thelimbshouldbeplacedina
positionslightlybelowbodylevel.
Thedeflatedcuffandanyunderlyinglimbprotection
materialshouldbecompletelyremovedassoonas
tourniquetpressureisreleased.Afterthecuffhas
beenfullydeflatedandremovedfromthepatient,
theunitcanbesettoSTANDBY.Eventheslightest
impedanceofvenousreturnmayleadtocongestion
andpoolingofbloodintheoperativefield.
WheneverIVRA(BierBlockanesthesia)isused,itis
recommendedthatthetourniquetremaininflatedfor
atleast20minutesfromthetimeofinjection.
1.5ADVERSEEFFECTS
Adullachingpain(tourniquetpain)maydevelop
throughoutthelimbfollowinguse.Stiffness,weakness,
reactivehyperemia,&skindiscolourationmayalsooccur
tosomedegreeinallpatientsaftertourniquetuse.
Pathophysiologicchangesduetopressure,hypoxia,
hypercarbia,andacidosisofthetissuesoccurandbecome
significantafterabout11/2hoursoftourniquetuse.
Symptomsoftourniquetparalysisaremotorparalysisand
lossofsenseoftouch,pressure,andproprioceptive
responses.
Intraoperativebleedingmaybecausedby:
1. Theslightimpedingeffectexertedbyan
unpressurizedcuff(anditslimbprotectionmaterial
orpadding,ifused),whichpreventsvenousreturn
atthebeginningoftheoperation,
2. Bloodremaininginthelimbbecauseofinsufficient
exsanguination,
3. Inadequatetourniquetpressure,orslowinflation
anddeflation,allifwhichallowarterialbloodto
enterwhilepreventingvenousreturn,
4. Bloodenteringthroughthenutrientvesselsofthe
longbones,suchasthefemurorhumerus.


6

INSTALLATIONANDOPERATINGINSTRUCTIONS
SECTION2.0
DELFIPTSiiTOURNIQUETSYSTEM
2.1INITIALINSPECTION
UnpackthePTSiiuponreceiptandinspecttheunitfor
anyobviousdamagethatmayhaveoccurredduring
shipment.Werecommendthatthisinspectionbe
performedbyaqualifiedbiomedicalengineerorother
personthoroughlyfamiliarwithelectronicmedical
devices.Iftheunitisdamaged,notifythecarrierand
Delfiimmediately.Iftheinitialinspectionresultsare
satisfactory,afunctionalandcalibrationcheckshouldbe
performedafteran10hourcharge.Theattentionlabel
coveringthepressure/timedisplaywindowbuttonmay
beremovedanddiscardedaftertheinitial10hourcharge.
2.2CONTROLS,INDICATORS,LCDDISPLAY,AND
CONNECTORS
RefertoFigure2.1forthelocationsoftheunit'scontrols,
indicators,displaysandconnectorsdescribedbelow:
1.ON/STANDBYButton
Turnstheunitonorsetstheunittostandby.Instandby
mode(poweredoff),thepowertoallinstrument
functions(i.e.inflation,deflation,etc.)isoff,butpower
continuestosupplythebatterychargingcircuitry
wheneverACpowerispresent.Thisbuttonwillnotset
theunittostandbywhenthereispressureinthecuff.
Ensurethecuffisfullydeflated,andthecuffandlimb
protectionmaterialhavebeenremovedfromthepatient
priortosettingtheunittostandby.
2.INFLATEButton
Inflatesthecufftothepressuresetpointandstartsthe
elapsedtimemonitor.Momentarilydepressingthe
‘INFLATE’buttonimmediatelybeginsrapidinflationofthe
cuff.
3.DEFLATEButton
Deflatesthecuffandstopstheelapsedtimemonitor.To
preventaccidentaldeflationofthecuff,the‘DEFLATE’
buttonhasadelayandmustbepressedandheldfor
approximately2secondsbeforetheunitwilldeflatethe
cuff.Ashorttoneissoundedafterthe2seconddelayto
indicatethatdeflationhasstartedandtheusermaythen
releasethe‘DEFLATE’button.Iftheusermomentarily
pressesthenreleasesthe‘DEFLATE’button,nothing
happens.Iftheuserreleasesthe‘DEFLATE’buttonany
timeafterdeflationhasbegun,thecuffcontinuesto
deflatetozeropressure.
4.MULTIFUNCTIONButtons
Thefourbuttonslocatedunderneaththedisplayscreen.
Theactionassociatedwithabuttonisclearlyindicatedby
theicondisplayedabovethebutton.Moredetails
regardingthefunctionsofeachofthesebuttonsis
providedinthesectionsbelow.

IconFunction

Setpressuresetpoint

Settimelimitsetpoint

Printeventhistory

Systemsettingsandspecialfunctions

Gobacktothepreviousscreen

Increment

Decrement

Acknowledge

AlarmSilence
Silencetheaudioalarmfor30seconds

Resetelapsedinflationtimetozero

Leaktest

Stopacuffleaktest

5.ColorDisplay
ThecolorLCDdisplayofthePTSiiconveysvarious
operatinginformationtotheuser.Duringnormal
operationwithnobuttonsbeingpressed,thedisplay
showsthecurrentsensedcuffpressureinmmHgandthe
numberofminutesthecuffhasbeeninflated(tourniquet
time).Alarmconditionsandbatterylevelindicatormay
alsobedisplayeddependingontheoperatingconditionof
thesystem.

7
6.ACPowerIndicatorLight
ThegreenACpowerindicatorlightisilluminatedatall
timeswhenACpowerispluggedintothePTSii,bothin
ONandSTANDBYmodes.NotethattheACpower
indicatorlightremainsoffatalltimeswhenthereisnoAC
powerconnectedtothePTSii.
7.AlarmIndicatorLight
Theredalarmindicatorlightisilluminatedwhenany
alarmconditionexists.Thealarmindicatorwillremain
illuminateduntilthealarmconditioniscorrected,aslong
assufficientpowerisavailable.
8.BatteryIndicatorSymbol
Thebatteryindicatorsymbolinthecenterofthecolor
LCDdisplayisvisiblewhenthePTSiiisonandoperating
onbatterypower(ACpowernotconnected).Thebattery
indicatorsymboliscomposedofacoloredbaranda
batteryicon.Thelengthandcolorofthebarindicatethe
chargelevelofthebattery.Whenthecoloredbar
completelyfillsthebatteryicon,thebatteryhasafull
charge.Reducinglengthofthebarandthechangein
colorfromgreentoredprogressivelyindicatedecreasing
batterycapacityandtheneedforrecharging.Thebattery
indicatordisappearswhenACpowerisconnectedtothe
PTSii.
9.HoseConnector
Thehoseassembly(seebelow)leadingtothetourniquet
cuffplugsintothePTSiiunitatthehoseconnector.The
hoseconnectorisapositivelockingtypethatmakesan
audible‘click’whenproperlyconnected.
10.HoseAssembly
OnehoseassemblyissuppliedwitheachPTSiiunit.The
malepositivelockingconnectorplugsintothehose
connectoronthePTSiiunit(seeabove).Thefemaleend
attachestothetourniquetcuff.ThePTSiiisdesigned,
tested,andrecommendedforusewithDelfiandother
singleportcuffshavingPositiveLockingConnectorsonly.
Usethesuppliedhoseassemblyonly.Anadapteris
providedwiththePTSiiunitforconnectiontocalibration
equipment.
ToengagePositiveLockingConnectorsfullydepressand
thenreleasethemetallockingbutton.Carefullyslidethe
connectorstogether.Anaudible‘click’canbeheard
whenproperlyconnectedandlocked.Todisengagefully
depressandholdthemetallockingbutton.Carefully
separatetheconnectorwhileholdingthemetallocking
button.Excessiveforceisnotrequired.TopreventO‐ring
damagethemetallockingbuttonmustalwaysbeinthe
openpositionbeforeconnectorsareengagedor
disengaged.
11.PowerReceptacle
Thepowerreceptacleislocatedontheleftofthebattery
fromarearviewofthePTSiiunit.ThePTSiiisdesigned
forusewiththesuppliedACpowersupply(seebelow)
only;donotuseanyothertypeofconnectiontoAC
power.
12.ACPowerSupply
AnACpowersupplyadapterissuppliedwitheveryPTSii
unit.ItisasealedunitdesignedspecificallyforthePTSii.
ContactDelfiifyourpowersupplyneedsserviceor
replacement.PlugtheconnectorontheACpowersupply
cordintotheACpowerreceptacleonthePTSiiunit(see
above),andplugtheACpowercordintoapoweroutlet
(seebelow)wheneverusingtheunitwhereACpoweris
easilyaccessible.
13.ACPowerCord
AnACpowercordwithahospitalgradeplugissupplied
witheveryPTSiiunit.Plugthesocketendofthecordinto
theACpowersupplyandtheplugendintoanACpower
outlet.
14.TourniquetInformationPort
Locatedontherightofthebatterycompartmentfroma
rearviewofthePTSiiunitthetourniquetinformation
portconnectstoanexternalprinter(DelfiREF9‐2200‐
350)ortoanexternalinformationsystem.
15.Polemountbracketattachmentpoints
UsedtosecurethePTSiiinstrumenttoapolemounting
bracket.UseonlyDelfiREF7‐2200‐008bracketforsingle
systemsorDelfiREF7‐2200‐009bracketfortwinsystems.
SeeFigures2.2and2.3
Note:Toensurestabilitydonotmountaboveaheightof
5.0’(1.5m)onmobileIVpoles.

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4
5
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9
10
11
12
13
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Figure2.1:PTSiiControls,Indicators,Displays,andConnectors
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Figure2.2:PTSiiSinglesystemmountingbracket(7‐2200‐008)
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Figure2.3:PTSiiTwinsystemmountingbracket(7‐2200‐009)
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10
2.3INITIALSETUP
Duringshippingandstorage,theunit'sbatterycould
becomeweak.Priortoinitialuse,theunitmustbe
pluggedintoACpowerusingtheACpowersupplyand
cordassemblyuntilthebatteryisfullycharged.This
initialchargeshouldtakenomorethan10hours.The
batterymustbefullychargedbeforeanyinitialuse,
includinganycalibrationcheckingprocedures,initial
checks,ortestsperformedbybiomedicalengineering
atyourfacility.
WARNING:UseonlyaDelfiREF7‐2200‐020or
7‐2200‐021ACpowersupplyandcordassembly
suppliedwithyourPTSii.DonotuseanyotherAC
powersupplyorcord.Useofanimproperpower
supplymaycauseirregularoperationthatcouldbe
hazardoustothepatientand/oruser,andmay
permanentlydamagethePTSiiunit.
CAUTION:AvoidexposingtheACpowersupplyto
liquids.Donotimmerseinfluid.DonotallowtheAC
powersupplytolieonthefloorwherepoolingof
liquidsmayoccur.Cleanbydampcloth(alcoholor
milddetergentwipe)only.TheACpowersupplyis
resistanttooccasionalsplashingordrippingoffluids,
butisnotfluid‐tight.Ifimmersedinorexposedto
excessiveamountsofliquids,theACpowersupply
mayfailandmayposeanelectricalshockhazard.
WARNING:UsebatterypackssuppliedbyDelfionly.
Donotuseanyotheranyotherbatterypack.Useof
animproperbatterypackmaycauseirregular
operationthatcouldbehazardoustothepatient
and/oruser,andmaypermanentlydamagethePTSii
unit.
2.4FUNCTIONALANDCALIBRATIONCHECK
EachPTSiiunitisfullytestedbeforeshipping.
However,thefollowingfunctionalandcalibration
checksshouldbeperformedbytheuserbeforethe
firstclinicaluseofthePTSiiunittoensurethatithas
notbeendamagedinshipping.Afterchargingthe
batteryasdescribedabove,theunitshallproducethe
resultsexplainedinthefollowingstepsexactlyas
indicated.Failuretodosoindicatesthataproblem
mayexistandthedeviceisnottobeuseduntil
necessaryrepairorcalibrationhasbeenmade.
2.4.1ACPOWERCONNECTIONANDINDICATOR
ConnectthepowersupplytothePTSiisystemthen
connecttheACpowerplugtoaproperlypolarizedand
groundedpowersourcewithvoltageandfrequency
characteristicscompatiblewiththespecificationslisted
inSection1.1.ObservethatthegreenACpower
indicatorlightturnson.

2.4.2POWER‐UPSEQUENCEANDSELF‐TESTS
Poweruptheunitbypressingthe‘ON/STANDBY’
buttonandobservethefollowing(thePTSiimaybe
pluggedintoACpowerornotfortheremainingtests):
a) ThebacklightoftheLCDdisplaylightsup,a
welcomescreen(Figure2.2)isdisplayed,anda
welcomeaudiotoneissounded.NotethatifAC
powerisnotconnected,thegreenACpower
indicatorlightdoesnotcomeonatanytime,andif
ACpowerisconnecteditremainsonconstantly.
Figure2.2
WelcomeScreen
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b) Self‐testscreenisdisplayed(Figure2.3).During
thistime,theunitisself‐testingspecificsystem
hardwareandsoftware
Figure2.3
SelfTestScreen
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11
c) Calibration‐checkisdisplayed(Figure2.4).
Duringthistime,theunitischeckingitscalibration
atzeropressure.
Figure2.4
CalibrationCheck
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d) Mainscreenisdisplayed(Figure2.5).Thecuff
pressureandtourniquettimeareshown.The
batterystatusindicatorwillnotbeshownifthe
unitispoweredfromanACsupply.
Figure2.5
MainScreen
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2.4.3CALIBRATIONCHECK
NOTE:EveryPTSiiunitiscalibratedatthefactory
beforeshipping.Theunitalsoself‐testsspecific
calibrationparametersuponpower‐up.Shoulda
potentialoutofcalibrationconditionbedetected,the
unitwilldisplayerrormessages(seeTable2.1).
Howevereventhoughtheunitperformsaself‐testof
calibrationateverypower‐up,thefollowing
quantitativecheckisrecommendedpriortoinitial
use,andatregularintervalsaccordingtothepolicies
inyourpracticesetting.
a)ConnectthePTSiihosesettothePTSiiunit,then
connectthehosetoareferencepressuregauge
knowntobeaccurate(e.g.manometeror
calibratedgauge).Ifrequired,usethePositive
LockingConnectortoLueradaptersuppliedwith
yourPTSiiunittoconnecttheendofthePTSii
hosetothereferencegauge.
b)Poweruptheunitbypressingthe‘ON/STANDBY’
button.
c)Enterthepressureadjustmentmodebypressing
thepressureadjustmentbutton.
d)Setthepressuresetpointto100mmHg(see
section2.6).
e)Presstheinflatebutton.
f)Allowthepressuretostabilize.Thepressure
readingonthePTSiiandthereferencegauge
shouldbewithin5mmHgofeachother,andwithin5
mmHgofthepressuresetpointof100mmHg.
g)Repeatstepsc)tof)abovefor250mmHgand475
mmHg.
h)Pressandholdthe‘DEFLATE’buttonfor2seconds
todeflatetheunit.Disconnectthehosefromthe
PTSiiunit.Thepressurereadingshoulddecrease
to0mmHg.
i)Ifanystabilizedpressurereadingisoffbymore
than5mmHgduringthecalibrationcheckorthe
pressuredisplaydoesnotreturntozero,theunit
mustbecalibrated.SeeSection3.3below.
2.4.4ALARMCHECK‐“LOWPRESSURE”and“CUFFLEAK”
ConnectthehoseassemblyandacufftothePTSiiand
pressthe‘INFLATE’button.Thecuffinflatestothe
defaultpressuresetpointof250mmHg.Createaleak
bypartiallydetachingthehosefromtheunitwhilethe
cuffisinflated.Maketheleaklargeenoughthatthe
pressuredropsmorethan15mmHgbelowsetpoint.
ThepumpinthePTSiiunitwillstartastheunittriesto
maintainthesetpressure.Afterthecuffpressurehas
beenmorethan15mmHgbelowthesetpoint
constantlyformorethan1second,confirmthat:
a)A“LOWPRESSURE”messagealternateswiththe
cuffpressuredisplay(a“CUFFLEAK”messagemay
alsoappear);
c)Theredalarmindicatorlightisilluminated;
d)Thealarmtonesoundsconstantly.
e)Pressthealarmsilencekeytosilencethealarm
tone.Confirmthatthealarmtonerestartsafter30
seconds.Stoptheleakandconfirmthatthe
displayedpressurereturnstothesetpointand
stopsflashing,the“LOWPRESSURE”(and“CUFF
LEAK”ifpresent)messagesdisappear,thered
alarmindicatorlightturnsoff,andthealarmtone
stops.

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2.5PRESSURESETPOINTADJUSTMENT
a)Atthemainscreen(Figure2.5),momentarilypress
thepressureadjustmentbutton.ThePTSiiwill
displaythepressureadjustmentscreen(Figure
2.6).Apressuregaugeiconisdisplayedandthe
pressuresetpointishighlightedtoindicatethat
thesetpointisbeingadjusted.
b)Usetheincrementanddecrementbuttonsto
modifythepressureset‐pointvalue.
Momentarilypressingtheincrementbuttonwill
increasethesetpointby5mmHg.Whenthe
buttonisheldthesetpointwillincreaseby10
mmHgeverysecond.Momentarilypressingthe
decrementbuttonwilldecreasethesetpointby5
mmHg.Whenthebuttonisheldthesetpointwill
decreaseby10mmHgeverysecond.
c)Pressthebackbuttontoreturntothemainscreen.
ThePTSiiwillautomaticallyreturntothemain
screenafter3secondsifnobuttonsarepressed.

Figure2.6
PressureSetPointAdjustment

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d)Notetoincreasethepressuresetpointabove
475mmHgconfirmationisrequired(Figure2.7).
MomentarilypresstheOKbuttontoenter
extendedpressuremodeorthepressbackbutton
toreturnwithoutenteringextendedpressure
mode.Ifconfirmedpressuresabove475mmHg
maybeselected.Thepressureset‐pointvalueand
cuffpressureareshownwithayellowbackground
whenapressuresetpointgreaterthan475mmHg
hasbeenselected.
Figure2.7
ExtendedPressureMode

2.6TIMELIMITSETPOINTADJUSTMENT
a)Atthemainscreen(Figure2.5)momentarilypress
thetimelimitadjustmentbutton.ThePTSiiwill
displaythetimeadjustmentscreen(Figure2.8).An
alarmclockiconisdisplayedandthetimelimitset
pointishighlightedtoindicatethetimelimitset‐
pointinbeingadjusted
b)Usetheincrementanddecrementbuttonsto
modifythepressureset‐pointvalue.Momentarily
pressingthebuttonlabeledwiththeuparrowwill
increasethesetpointby5min.Whenthebutton
isheldthesetpointwillincreaseby10minevery
second.Momentarilypressingthebuttonlabeled
withthedownarrowwilldecreasethesetpointby
5min.Whenthebuttonisheldthesetpointwill
decreaseby10mineverysecond.
c)PresstheBACKbuttontoreturnbacktothemain
screenorwaituntilthePTSiiautomaticallyreturns
tothemainscreen.
Figure2.8
TimeLimitSetPointAdjustment


13
2.7.TOURNIQUETTIMERESET
Theelapsedtourniquettimemayberesettozeroat
anytimeafterthecuffhasbeeninflated.
a)Atthetimelimitsetpointadjustmentscreen
(Figure2.7)momentarilypresstheTIMERESET
button.Theresetconfirmationscreenwillbe
shown(Figure2.9).PresstheOKbuttontoreset
thetimeortheBACKbuttontoexitwithout
resettingthetime.
Figure2.9
TimeResetConfirmation


2.8SETUP/SPECIALFEATURES
Thesetup/andspecialfeaturesmenu(Figure2.10)can
onlybeaccessedwhenthecuffisdeflated.
a)Atthemainscreen(Figure2.5)momentarilypress
theSettingsbuttontoselectthesetupandspecial
featuresmenu.Usetheincrementanddecrement
buttonstomovethehighlightingboxupanddown
toselectfromthefollowing:
.

Initiateatestforleakagefrom
thecuff,hose,andconnectors

Setthedefaultpressureset
point

Setthedefaulttimelimit

Selecttheprinterlabelsize

Adjusttheaudioalarmvolume

Selectthesystemlanguagefor
messagesandprintedtext

Figure2.10
SystemSettingsandSpecialFeatures


2.9LEAKTEST
ThePTSiitourniquetsystemincludesanautomatictest
tocheckforleakagefromanattachedcuff,hoseand
connectors.
a)Atthemainscreen(asshowinFigure2.5)press
thesettingsbuttontoenterthesettingsmenu(as
showninFigure2.10).
b)Toperformatestforleakagefromthecuff,hose,
andconnectors,movethehighlightingboxtothe
cufficonandpresstheOKbutton.
c)ConnectthecuffasshowninFigure2.11.

Figure2.11
LeakTestInstructions


WARNING:Donotstarttheleakagetest(pressthe
INFLATEbutton)ifthecuffisappliedto
apatient.
e) PresstheINFLATEbuttontostartthetestThe
testcanbestoppedatanytimebypressing
theSTOPbutton,thiswilldeflatethecuff
(Figure2.12).

14
Figure2.12
LeakInProgress

f) Thecuffwillinflatetoapproximately250
mmHganda30secondleaktestwill
commence.Attheendofthetestthecuffwill
automaticallydeflateandthetestresultwill
display(Figure2.13).PressingtheCUFFLEAK
buttonwillrepeatthetest.

Figure2.13
LeakTestComplete

g) PressingthePrintbuttonwillprintatest
summaryiftheoptionalprinterisconnected
(Figure2.14).
Figure2.14
Printedleaktestsummary


2.10SETDEFAULTPRESSURE
Thepressuresetpointwillbesettothedefault
pressurewhenthesystemispoweredon.
a)Atthemainscreen(Figure2.5)pressthesettings
buttontoenterthesettingsmenu(Figure2.10).
b)Toadjustthedefaultpressuresetpoint,movethe
highlightingboxtothepressuregaugeiconand
presstheOKbutton.
c)Usetheincrement/decrementbuttonstoadjust
thedefaultpressuresetpoint(Figure2.15).Use
theOKbuttontoacceptthenewdefaultpressure
setpoint,andreturntothesettingsmenu.
Figure2.15
DefaultPressureAdjustment


2.11SETDEFAULTTIMELIMIT
Thetimelimitsetpointwillbesettothedefaulttime
limitwhenthesystemispoweredon.

a)Atthemainscreen(asshowinFigure2.5)press
thesettingsbuttontoenterthesettingsmenu
(Figure2.10).
b)Toadjustthedefaulttimelimitsetpoint,movethe
highlightingboxtotheclockiconandpresstheOK
button.
c)Usetheincrement/decrementbuttonstoadjust
thedefaulttimelimitsetpoint(Figure2.16).Use
theOKbuttontoacceptthenewtimelimitset
point,andreturntothesettingsmenu.

15
Figure2.16
DefaultTimeLimitAdjustment


2.12PRINTERLABELSIZE
Selectthesizeofthelabelsusedforprintingevent
historiesandcuffleaktestrecords.
a)Atthemainscreen(asshowinFigure2.5)press
thesettingsbuttontoenterthesettingsmenu
(Figure2.10).
b)Toselectalabelsize,movethehighlightingboxto
theprintericonandpresstheOKbutton.
c)Usetheincrement/decrementbuttonstoselect
theprinterlabelsize(Figure2.17).PresstheBACK
buttonwhendonetoreturntothesettingsmenu.
Figure2.17
PrinterLabelSize


2.13ALARMVOLUME
Adjustthevolumeoftheaudiotonesusedtosignal
alarms.
a)Atthemainscreen(asshowinFigure2.5)press
thesettingsbuttontoenterthesettingsmenu
(Figure2.10).
b)Toadjustthealarmvolume,movethehighlighting
boxtothespeakericonandpresstheOKbutton.
c)Usetheincrement/decrementbuttonstoadjust
thealarmvolume(Figure2.18),.Presstheback
buttonwhenfinishedadjustingthevolumeto
returntothesettingsmenu.
Figure2.18
AlarmVolumeAdjustment


2.14LANGUAGE
Selectthelanguagethatwillbeusedforallalarm
messages,instructions,andprintedtext.

a)Atthemainscreen(asshowinFigure2.5)press
thesettingsbuttontoenterthesettingsmenu(as
showninFigure2.10).
b)Toadjustthesystemlanguage,movethe
highlightingboxtotheglobeiconandpresstheOK
button.
c)Usetheincrement/decrementbuttonstoselect
thesystemlanguage(Figure2.19).PresstheBACK
buttonwhendonetoreturntothesettingsmenu.
Figure2.19
LanguageSelection


2.15PRINTER
ThePTSiimaybeusedwithanoptionalindustry
standardthermallabelprinter(DelfiREF9‐2200‐150).
TheprinterissuppliedfromDelfiwithanappropriate
interfacecableforusewitheitherasinglePTSiisystem
orwithtwoPTSiisystemsinaTwinconfiguration.

16
Followtheinstructionsincludedwiththeprinterto
setupandconnecttheprintertothePTSiisystem(s).
Note:WhenusingaprinterwithtwoPTSiisystemsina
TwinconfigurationbothPTSiisystemsmustbe
poweredoninordertoprint.
DuringasurgicalprocedurethePTSiimaintainsa
recordoftourniqueteventssuchastourniquet
pressuresetting,cuffinflation,cuffdeflation,alarm
eventsandchangesinalarmlimits.Thetourniquet
eventrecordmayprintedatanytimebypressingthe
printbutton.
Pressingtheprintbuttonwiththeprinterdisconnected
orpoweredoffwillproducea“NoPrinter”alarm.If
theprinterisconnectedandunabletoprinta“Check
Printer”alarmwillbeproduced.(SeeTable2.1)
Thetourniqueteventrecordisremainsinthememory
ofthePTSiiwhenthePTSiisystemissettoStandby.
Thetourniqueteventrecordisnotclearedandnew
recordstarteduntiltheInflationbuttonispressed
whenthetourniquettimeiszero
ThePTSiimaybeconfiguredtoprinttherecordona
single4”x6”adhesivebackedlabel(Figure2.20).or
ontwo2.25”x3”adhesivebackedlabels(Figure2.21).
Spaceisprovidedontheprintedlabelstorecord
relevantinformationtotheifsodesired.

Figure2.20
PrintedEventRecord(singlelabel)


Figure2.21
PrintedEventRecord(twolabels)
 


2.16OPERATION
NOTE:ThePTSiiunitshouldbepoweredupatleast
onceeachdayofusetoensuretheself‐testroutineis
performedregularly.ThePTSiishouldbepowered
offandleftpluggedintoACpowerwhennotinuse.
a)Pressthe‘ON/STANDBY’buttontoturntheunit
on.Theunitwillexecuteaself‐checkdiagnostic
testasdescribedinSection2.4.2ofthismanual.
Successfulcompletionoftheself‐checkindicates
thattheunitisreadyforuse.
WARNING:Ifaconnectedcuffispressurizedto50
mmHgormoreduringpower‐up,thePTSiiwill
assumethatasurgicalprocedureisinprogress,adopt
thepressuresensedinthecuffasthenewsetpoint,
andwillautomaticallyregulatethecuffatthis
pressure.Toalerttheoperatorofthiscondition,the
unitwillsoundthealarmtone,illuminatethered
alarmindicatorlight,andflashthepressuredisplay.
Theoperatorshouldimmediatelycheckthepressure
setpointandreadjusttothepropersetpointif
necessary.Thealarmwillbeclearedassoonasthe
setpointisexaminedoradjustedviathepressure
adjustmentmode.
b)Connectthehoseassemblyandasingleportcuff
totheunitatthehoseconnector.
c)Selecttheappropriatetourniquetpressureand
timelimitsetpointsforthespecificprocedure,as
specifiedbythesurgeon.Thedefaultsetpointsfor
pressureandtimelimitareretrievedfromthe
memoryduringpowerupandareactiveuntilthe
useradjuststhem(seeSections2.5and2.6).
Thesedefaultvaluescanbemodifiedbytheuser
(seeSections2.10and211).
WARNING:Inallcasesitisessentialtocheckthe
pressureandtimelimitsetpointsandconfirmthat
theyarethedesiredvaluesbeforeinflatingthecuff.

17
Foreachpatient,tourniquetpressurerequiredto
occludebloodflowtotheoperativesiteshouldbe
settotheminimumeffectivepressure.The
minimumeffectivepressuredependsonmany
factors,includingthelocationofthecuff(upperor
lowerlimb),thetypeofcuffandqualityoffitto
thelimb,whetherthelimbisnormal,
hypertrophied,orobese,thepatient's
preoperativesystolicpressure,andthemaximum
anticipatedriseinsystolicpressureduringthe
procedure.Refertothemedicalliteraturefor
currenttechniquesfordeterminingtheminimum
effectivetourniquetpressureforeachcase.
d)Preparethepatientinaccordancewithyour
establishedproceduresandcuffmanufacturer's
instructions.TheprecautionsofSection1andthe
followingareofferedasaguidetoassistinthis
process.Inmostcasesatourniquetcuffshouldbe
appliedtothewidestpartofthelimbtoallowas
muchtissueaspossibletoliebetweenthecuffand
anynervesorvascularstructuressusceptibleto
damage.Theoptimumpositionsaretheupperarm
andtheproximalthirdofthethigh.Incertain
casesoffore‐footsurgery,thetourniquetcuffcan
beappliedaroundthecalfortotheareaproximal
tothemalleoli.Foremergencysurgeryofthe
hand,asufficientlysmalltourniquetmaybe
selectedbythesurgeonforfittingaroundthe
forearm.Applyaleak‐freetourniquetcuff
smoothlywithoutwrinklesThehoseconnections
shouldbeplacedsothatthehosewillnotbe
kinkedwhenthelimbispositionedforsurgery.The
viabilityoftheskinanddeepertissuesshouldbe
establishedpriortoexsanguinationofthelimband
tourniquetinflation.Exsanguinatethelimbby
elevatingitforaminimumof2minutesand
wrappingit,distaltoproximal,usinganEsmarch,
Martin,orelasticbandage.Thebandageshould
comeupapproximatelyto1in.(2.5cm)fromthe
edgeofthetourniquetcuff.Theelasticbandageis
removedfollowinginflationofthecuff.Ifregional
anesthesiaisbeingused,theanestheticagentor
nerveblockisthenadministered.Thesurgeonwill
determine:
Whenthetourniquetistobeinflated;
Whatpressureisapplied;
Howlongthetourniquetisapplied;
Whethertoallowforintermittentaerationof
tissuebydeflatingthecuff,andthedurationof
theseaerationperiods;
Whentodeflateandremovethetourniquet.
Appropriatetourniquettimeandtheneedfor
intermittentdeflationofthecuffdependgreatly
onthepatient'sanatomy,age,andabsenceof
vasculardisease.Inmanyoperatingrooms,itis
customarytoprominentlynotethetimeof
inflation,andtowarnthesurgeonafteracertain
timehaselapsed.Thiswillallowthesurgeonto
assesstheneedforfurthertourniquettime.
e)PresstheINFLATEbuttonwhenthecuffmustbe
inflated.Theunitwillpressurizethecufftothe
pressuresetpointandstartthetourniquettime
clock.Iftheunitcannotpressurizethecuffto
within15mmHgofthesetpointinlessthan20
seconds,aleakalarmwillbesounded(seeTable
2.1forinformationaboutpossiblealarm
conditions).Thecurrentpressureinthecuffand
thetourniquettimeareshownontheLCDdisplay.
f)Whenthecuffmustbedeflated,pressandhold
theDEFLATEbutton.Afterholdingthebuttonfor
2seconds,thealarmtonewillsoundbriefly,the
pressuredisplaywillshowthefallingpressureof
thecuff,andthetourniquettimeclockwillstop
andholdthedisplayofthetourniquettime.
Removethetourniquetcuffandanyunderlying
limbprotectionmaterialimmediatelyfollowing
finalcuffdeflation.Thetimeoftourniquetcuff
removalshouldbenoted,andthecirculationof
thelimbshouldbechecked.Ifaminorleakwas
detectedduringthesurgicalprocedureaprompt
willbedisplayedstating“TESTFORLEAKS”.The
usershouldfollowthestepslistedinsection3.4to
testforleaks.
NOTE:Theelapsedtourniquettimecanbezeroed
afterthecuffisdeflatedbyfirstenteringthetime
adjustmentmodebypressingthetimelimit
adjustmentsoftkeyatthemainscreen,followedby
pressingthetimeresetsoftkey(toresettourniquet
time).Notethattheresetfeatureisonlyavailable
whenelapsedtourniquettimeisnon‐zero.
g)Afterthecuffhasbeenremoved,disconnectthe
cufffromthePTSii.Duringnormaluse,thePTSii
shouldnotbesettostandbyifpressureispresent
inthecuff.Oncethecuffhasbeenproperly
deflated,removedfromthepatientand
disconnectedfromthePTSii,theunitcanbesetto
standby.

18
2.17ALARMCONDITIONS
ThereareanumberofconditionsforwhichthePTSii
willproducevisualandaudiblealarms.Those
conditions,indicationsandappropriateactionsare
showninTable2.1.Theappropriateactionsindicated
arebasedonthemostprobablecausesandshouldonly
beusedasaguide.Othercausesofalarmconditions
mayindicateaneedforotheractions.
Thealarmindicatorlightisilluminatedandanaudible
alarmtoneisproducedwheneveraalarmconditionis
detected.
2.20.1ALARMSILENCEFUNCTION
Mostaudiblealarmtonesmaybesilencedfor30
secondsbymomentarilydepressingthealarmsilence
buttonwhichisdisplayedwheneverasilencablealarm
conditionispresent.Attheendofthesilencedperiod,
thealarmtonewillrestartifthealarmconditionhas
notbeencorrected.Thealarmtonemaybesilenced
foradditional30secondperiodsasrequired.
2.20.2PRESSUREHIGHorLOWALARMS
A"HIGHPRESSURE"or"LOWPRESSURE”alarmwill
occurwhenthepressureinacuffismorethan15
mmHgfromthepressuresetpoint.Tominimize
nuisancealarmsthatcanbecausedbyvigorous
movementofthepatient'slimbs,a1seconddelayhas
beendesignedintoalarmactuationforthese
conditions.
2.20.3.LEAKALARMS
Itispossibleforthesystemtohaveasubstantialleak
thattheunitcancompensateforbycontinual
pumping.Thistypeofleakcouldbeduetoaholein
thecufforhoseassembly,alooseorwornhose
connector,orleaksinthepneumaticcircuitinsidethe
PTSiiunit.Allleaksrequireimmediateattention,
becausetheycouldprogressintoatotalfailureofa
cufftoholdpressureatanytime.Toalerttheoperator
thatasubstantialleakispresent,the“CUFFLEAK”
alarmisactivatedwhenthistypeofleakiscontinuously
presentformorethan7seconds,eveniftheunitis
maintainingthecuffpressurewithin15mmHgofthe
setpoint.Ifa“CUFFLEAK”alarmoccurs,thecuff,hose
assembly,andhoseconnectorsshouldbecheckedfor
leaks.Ifanexternalleakcannotbefound,testthePTS
iiunitperSection3.4below.2.8.2.
2.20.4INTERNALHARDWAREFAILURES
When“SYSTEMERROR”andanumericerrorcode
appearinthepressureandtimedisplaysduringuseor
power‐up,aninternalhardwarefailurehaslikely
occurredandthePTSiiunitisunusable.Inthis
situation,itislikelythattheunithasputitselfinthe
‘safestate’mode,inwhichthepneumaticvalveand
pumparedisabledandthecurrentpressureinthecuff
isheld(intheabsenceofleaks).Itisalsolikelythata
tonewillsoundundertheseconditions.The‘safe
state’modehelpspreventunexpectedlossofocclusion
duringaprocedureifasuddenfailureoccurs.
Althoughitisveryunlikely,internalhardwarefailures
mayalsocauseerraticoperationand/orunintelligible
displayswithorwithoutalarms,andmayormaynot
putthePTSiiinthe‘safestate’mode.
Ifeithertypeoferroroccurs:
a)Settheunittostandbybypressingthe
‘ON/STANDBY’button.Thisremovespowerfrom
theinternalinstrumentcircuitryandallinstrument
functions,causingthecufftoholdpressure(inthe
absenceofleaks).
b)Ifrequired,attempttorestarttheunitbypressing
the‘ON/STANDBY’againtorestarttheunit.
c)Ifrequiredtocontinuetheprocedure,clampthe
hosewithahemostattomaintaincuffpressure,
thenimmediatelydisconnectthefaultyPTSiiunit
andconnectareplacementunit.
d)Ifcuffdeflationisrequired,disconnectthecuff
fromthePTSiiunit.
WARNING:Inallcasesofinternalhardwarefailure,
erraticoperation,orunintelligibledisplays,itis
possiblethatthepressureinthecuffisnotaccurately
displayedonthePTSiiunitandthatcuffpressure
maybepresentevenwhenthePTSiiunitappearsto
beshutdown.Theusermustimmediatelydetermine
ifthecuffisinflatedordeflatedandcontinually
monitorthecufftoensurepatientsafety.Ifdeflation
ofthecuffisnecessary,disconnectthehosefromthe
PTSiiunitorfromthecuffandconfirmthatthecuff
deflatescompletely.

19
Table2.1:AlarmsandWarnings

ConditionAppropriateaction/Remarks


TESTFORLEAKS
Theunithasdetectedleakage
fromthecuff,hose,or
connectorsduringthetimethe
cuffwasinflated.
PresstheOKbuttontoclearthe
warningmessage




Thiswarningisonlygivenwhenthecuff
isdeflated.
Ifduringthetimethatacuffisinflated
thePTSiidetectsminorleakagefromthe
cuff,hose,orconnectorsthiswarningis
given.
Inspectthecuff,hose,andconnectorsfor
damage.Performaleaktest(see2.X).




CUFFPRESSUREHIGH
Theunithasdetectedhigh
pressureinthecuff.High
pressureisdefinedaspressure
thatis+15mmHgabovethe
pressuresetpointcontinuously
formorethan1second

Alarmmessagealternateswithcuff
pressure.

Normallycausedbytransientconditions
suchaspatientmovement,regulator
overshoot,orhoseocclusion.This
condition,foranextendedperiod,would
indicateahardwarefailureandthePTSii
unitshouldbereplaced.
Alarmwillstopautomaticallywhenever
theunitcanregulatethecufftowithin15
mmHgofthepressuresetpoint.




CUFFPRESSURELOW
Theunithasdetectedlow
pressureinthecuff.Low
pressureisdefinedaspressure
thatis+15mmHgbelowthe
pressuresetpointcontinuously
formorethan1second.


Alarmmessagealternateswithcuff
pressuredisplay

Thisconditionisgenerallycausedbya
leakinthecuff,hose,connectorsor
internalsystem.Connections,hose,and
cuffshouldbechecked.
Alarmwillstopautomaticallywhenever
theunitcanregulatethecufftowithin15
mmHgofthepressuresetpoint.