Prius Healthcare USA Salute RDX User manual

1505
 
SaluteRDX 
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3‐1Alternating
Anti‐DecubitusSystem

UserManual
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PriusHealthcareUSA
4029TampaRoad,Suite4000C
Oldsmar,FL34677,USA
TEL:(813)854‐5464
FAX:(813)854‐5442

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Content
1.ThePurposeofthisManual.................................................................................1
2.ProductDescription................................................................................................1
 MasterControlUnitFeatures
 MattressFeatures
3.TechnicalData...........................................................................................................3
 MasterControlUnit
 SaluteMattressReplacement
SymbolDefinition
4.InstructionforProperUse....................................................................................4
5.Cleaning........................................................................................................................7
TheMattress
 TheMasterControlUnit
 ReplaceAirFilter
WasteDisposal
6.StorageandCare.......................................................................................................8
7.MaintenanceandTroubleshooting...................................................................9
8.EMCRelatedNotification...................................................................................10
9.ExpectedServiceLife...........................................................................................14
10.Warranty................................................................................................................14

IMPORTANTSAFEGUARDS
When using electrical products, especially when children are present, basic safety
precautionsshouldalwaysbefollowed,includingthefollowing:
*HOUSEHOLDUSEONLY*
CAUTION‐READALLINSTRUCTIONSBEFOREUSINGTHEAPPLIANCE
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WARNING–Toreducetheriskofelectrocution:
1.Alwaysunplugproductimmediatelyafteruse.
2.Donotusewhilebathing.
3.Donotplaceorstoreproductwhereitcanfallorbepulledintoatuborsink.
4.Donotplaceinordropintowaterorotherliquids.
5.Donotreachforproductthathasfallenintowater.Unplugimmediately.
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WARNING–Toreducetheriskofburns,electrocution,fireorinjurytopersons:
1. Theproductshouldneverbeleftunattendedwhenpluggedin.
2. Closesupervisionisnecessarywhentheproductisusedby,on,nearchildren
orphysicallychallengedindividuals.
3. Usethe productonly foritsintended useas describedin thismanual.Donot
useattachmentsnotrecommendedbythemanufacturer.
4. Neveroperatethisproductifithasadamagedcordorplug,ifitisnotworking
properly,ifitishasbeendroppedordamaged,ordroppedintowater.Return
theproducttoaservicecenterforexaminationandrepair.
5. Keepthecordawayfromheatedsurfaces.
6. Neverblocktheairopeningofthisproductorplaceitonasoftsurface,suchas
abedorcouch,wheretheairopeningsmaybeblocked.Keeptheairopenings
freeoflint,hair,andothersimilardebris.
7. Neverdroporinsertobjectsintoanyopenings.
8. Donotuseoutdoors,operatewhereaerosol(spray)productsarebeingusedor
whereoxygenisbeingadministered.
9. DISCONNECTPOWERSUPPLYBEFOREOPENING.
10. Theproducthasnouserserviceablepartsexceptforfusereplacement.
11. Keepthepumpandtubing(includingprotectivesleeves)awayfromsources
ofliquidandopenflames.
12. Keepthepumpandtubingawayfromsharpobjects.
13. Ifpain,irritation,numbness,swelling,orrednessoccursdiscontinueuseand
contactahealthcareprofessional.
14. Powercable&pumpshallbeplacedatthefoot‐sideofthepatienttoprevent
anyriskofstrangulationduetocable.

1
1. ThePurposeofthisManual
Thisoperationmanualfocusesonthesetup,cleaningandroutinemaintenanceof
theSaluteRDX3‐1AlternatingAnti‐DecubitusSystem.Werecommendkeepingthis
manualavailabletoanswerquestionrelatedtothissystem.
2. ProductDescription
SaluteRDX3‐1AlternatingAnti‐DecubitusSystemis a pressure ulcer
preventionmattressreplacementsystemdesignedforuseinthehome,atanursing
facilityorinahospitalenvironment.Useofthissystemonastandardbedframeis
possible;howevertheuseofthissystemonabedframedesignedforahealthcare
environmentispreferred.
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The system consists of an electronic control unit with a membrane control panel
andareplacementmattresscontaining18aircellsarrangedinatransversemanner.
TheaircellsaredesignedwithMicroLowAirLossfeaturetoassistinmanagingthe
moistureonapatient’sskinbyallowingadditionalairtocirculate on mattress
surface.AnotheruniquefeatureistheHappyHeelTMwhichprovidesindependent
comfortcontrolsettingsfortheheelsectionallowingimprovedpatientoutcomesas
wellasadditionalpatientcomfort.
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MasterControlUnitFeatures
3‐1alternationandstatictherapy
IntuitiveLEDindicatorforfunctionstatus
8adjustablecomfortsetting
Visualandaudiblealarmsforlowpressureandpowerfailure
HappyHeelTMprovidesextracomfortsettingsfortheheelsection
Keypadlockoutfunction
MaintenanceserviceLEDremainder

2
Main Feature Description
Therapy Mode allows you to select Alternation or Stactic
Therapy.
Happy Heel is an independent pressure control for the heel
section of the mattress to assist in improved patient
outcome as well improving patient comfort.
Auto Firm allows for a quick inflation in stactic mode.
Alarm Mute allows you to mute the alarm while corrective
action is being taken to determine the cause of alarm.
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MattressFeatures
Therapeutic micro low air loss helps manage moisture and provides
alternatingtherapytopreventandtreatpressureulcers
Modularizeddesignallowsforeasycleaningandreplacementofaircells
Highlyvaporpermeableandoversizedpliablequiltednylontopcover
provideslowshear,frictionandmoistureprotection
CPRquickreleaseforrapiddeflation
Integrated power cable management assists in safety and organization of
powercables
Cellincelldesignprovidesadditionprotectionforuppertorsoandsacrumin
theeventthereisalossofpower
2” convoluted foam base provides additional safety in the event of a loss of
power
Recommendedmaximumsafeworkingcapacityof500lbs
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SaluteRDXAirMattressTherapySystemisrecommendedforuseintheprevention
andtreatmentofdecubitus(pressure)ulcersstageI–III(mediumrisk).Forhigher
riskpatientspleasecontactPRIUSHealthcareUSAforadditionalproductofferingsto
addresshigherriskpatients.(813)854‐5464
Caution
Alternatingpressuretherapyisnotrecommendedforpatientswhohaveseriouspain
orpain‐sensitivesymptom.InsuchcasespleasecontactPRIUSHealthcareUSAfor
additionalproductofferings.(813)854‐5464.

3
3.TechnicalData
MasterControlUnit
ModelName SaluteRDXControlUnit
ModelNo. FC‐PHR0032
Size(inch)LxWxH 13.5“x5.4“x8.3“
Weight(lbs) 7.5
CycleTime(min) 5,10,15,20min
MinOperatingPressure 12+/‐5mmHg
MaxOperatingPressure 47+/‐5mmHg
MaxFlow‐rate ≧6l/min
RatedVoltage AC110‐120V
MaxCurrent 0.2Amp
FuseRating 1A250V
RatedFrequency 60Hz
Classification ClassII,TypeBF
NotAP/APGtype
IngressofWater
Protection IP21
ModeofOperation Continuous
Environment
(Temperature)
Operation:15°Cto35°C(59°Fto95°F)
Storage:5°Cto60°C(41°Fto140°F)
Environment(Humidity) Operation:30%to75%non‐condensing
Storage:30%to90%non‐condensing
Standard
IEC60601‐1,
CAN/CSAC22.2No.601.1,
IEC60601‐1‐11
IEC60601‐1‐2
MattressReplacement
ModelName SaluteRDXAirMattress
ModelNo. FM‐PHR0033
Size(inch)LxWxH 80“x36“x8“
Weight(lbs) 25.3
CellsNumber 18cells
CellsMaterial NyloncoatedwithPU
CoverMaterial Nylonwovenfabricw/PUcoatingfinish
BaseMaterial WovenPolyesterfabricw/PVCbacking
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4
SymbolDefinition
TypeBF
ProtectionAgainst
ElectronicShock
ClassIIEquipment
OperatingInstructionsWasteDisposal
Caution,Consult
accompanying
documents
AlternatingCurrent
4. InstructionforProperUse
1. Removethecontrolunitfromtheboxandhangitatthefootendofthebedusing
thehooksonthebackofthecontrolunit.
2. Plugthepowercordintoanappropriateoutlet.
3. Ifapplicableremovetheexistingmattressfromthebedframe.
4. RemovetheSaluteRDXreplacementmattressfromitspackagingandplaceit
directlyonthebedframe.
5. Makesurethattheconnectinghoseispositionedatthefootofthebednearthe
controlunit.
6. Securethemattresstothebedframeusingthestrapsonthebottom of the
replacementmattresstopreventitfrommoving.
7. Connectthemattresshoseconnectortocontrolunit.Makesuretheconnectionis
secure.
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8. ChecktheCPRvalvetomakesureitissetinthe“Close”position.
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5
9. Turnonthecontrolunitusingthepowerswitchlocatedonthesideoftheunit.
Selecttheautofirmcomfortcontroldialforquickinflation.
10.Duringtheinflationprocess,thelowpressureLEDwillbedisplayed until the
mattressisproperlyinflated,.Theinflationtimeofthemattresscantake30to40
minutes.Forquickerinflationaportableblowerunitisavailable.Pleasecontact
PriusHealthcareUSAforadditionalinformation,(813)854‐5464.
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11.Whenthemattressisfullyinflated,setthedialinaccordancewiththepatient’s
sizeandweight.
Runthesystemcheck.
Thesystemisreadyforuse.
Nowthepatientcanbetransferredontothemattress.

6
AlarmFunction
TheSaluteRDX3‐1AlternatingAnti‐DecubitusSystemis equippedwithavisual
andaudiblealarmintheeventoflow pressure.Duringtheinitialinflationperiod
thesystemisinlowpressuremodeandthelowpressureLEDwillilluminate.The
audible alarm is set with a delay function to take into considerationtheinflation
time. The alarm will activate automatically after 45 minutes iftheunitdoesnot
inflateproperly.
When the mattress pressure drops from the set pressure during patient re‐
positioning the audible alarm will switch to a 5 minute delay to avoid undesired
alarmactivation.
Alarm Indication Description
Indicates a loss of power.
Indicates low pressure.
Indicates service is required after 8760 hours of use.
Deactivationofaudiblealarm:
Switchthepumpoffthenbackon,todeactivatetheaudiblealarm.
CPRValve
The SaluteRDX3‐1AlternatingAnti‐DecubitusSystemisequippedwithaCPR
emergencyvalvewhichfacilitatesarapiddeflationbyturningtheCPRvalvetothe
“OPEN”position.
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7
5.Cleaning
TheMattress
Themattressshouldbecleanedweeklyusingadampsoftclothandmilddetergent.If
the top cover or base cover becomes excessively soiled, put on clean gloves, plastic
gownandeyeprotectionandremovetopandbasecoversfromtheaircellsand
tubing.Placesoiledcoversinanappropriatecontainerinaccordance with your
facilities standard operating procedures for contaminated waste, replace mattress
withcleancovers.
Coverscanbewashedandthermallydisinfectedinawashingmachinebyfollowing
theproceduresbelow:(NOTE:Neverusephenolbasedcleaningsolutions).

Industrial Breakwash Cold 10minutes
Mainwash60
°C(140°F) 6minutes
Mainwash70
°C(158°F) 10minutes
 Extraction  2minutes
ColdRinse 
 Extraction  5minutes
Domestic Pre‐wash Cold 
MainWash70
°C(158°F) 10minutes
 Extraction  2minutes
ColdRinse 
 Extraction  5minutes
TumbleDryingorTunnelDryingisnotrecommended.
MattressCellscanbewipeddownwithasolutionofsodiumhypochlorite1000ppm
oranyothernon‐phenolbasedgermicidalcleaningsolution.
TheMasterControlUnit
Thepumpunitshouldalsobecleanedweeklyusingadampsoftcloth and mild
detergent.ThepumpcasingismanufacturedusingABSplastic,ifthecaseissoiledthe
pumpcanbewipeddownwithasodiumhypochloritesolutiondilutionof1000ppm
oranyEPAapprovedhospitalgradedisinfectant.
(NOTE:Donotusephenolbasedcleaningsolution).

Theairfiltershouldalsobecleanedandcheckedasoftenaspossibleataminimumof
everysixmonths.Theairfiltercanbeaccessedthroughtheair filter cover on the
backoftheunit.Toremove,pinchthecenterofthefilterandpullingoutward.
Caution
SWITCHOFFTHEELECTRICALSUPPLYTOTHEPUMPANDDISCONNECTTHE
POWERCORDFROMTHEMAINSUPPLYBEFORECLEANINGANDINSPECTION

8
ReplaceAirFilter
1. Removeair filtercover toaccessair filter.Pinchthecenterofairfilterand
pulloutward,replacewithanewfilter.
2. Ifairfilteropeningissoileduseasoftbristlebrushtoremovedustanddried‐
onsoil.

NOTE:
1. Donotuseanyphenolbasedcleaningsolutions.
2. Switchofftheelectricalsupplytothepumpanddisconnectthepowercordfrom
themainsupplybeforecleaningandinspection.
WasteDisposal
ThisProducthasbeensuppliedbyanenvironmentallyconscious
manufacturerthatcomplieswiththeWEEE.
Thisproductmaycontainsubstancesthatcouldbeharmfultothe
environment if disposed of in places that are not approved by your state,
local or federal laws.    Please be environmentally responsibleandrecycle
thisproductthroughyourrecyclingfacilityatitsendoflife.

6.StorageandCare
MasterControlUnit:
Checkthepowercordandplugforabrasionsorexcessivewear.
Pluginthecontrolunitandverifyairflowsfromtheunitshoseconnection
ports.
Placeinplasticbagforstorage.
OverlayMattress:
Checktheairmanifoldforkinksorbreaksandreplaceifnecessary.
TurntheCPRvalvetotheopenpositionanddisconnecttheairtubesfromthe
controlunittoallowthemattresstoquicklydeflate.Startingattheheadend
ofthemattressrolltheunitupandusethebasemountstrapstosecure.
Placemattressinaplasticbagofstorage.
Pleasefollowtherecommendedguidelinesbelowwhenthesystemisbeingstoredor
transportedtoanotherlocation:
Temperaturelimitations:  5°C(41°F)~60°C(140°F)
RelativeHumidity:   30%to90%

9
7.Maintenance&Troubleshooting
Daily maintenance is not required.  This equipment should only be serviced by a
qualifiedandauthorizedtechnician.Forcommontroubleshootingtipspleasereferto
thechartbelow.

SymptomInspectionProceduresPossibleSolution
Thepumpisnot
functioning.
1. Checkpowersource
connection.
2. Checkforblownfuse.

1. Connecttoproperpower
source.
2. Replacefuse.
3. Refertoqualifiedservice
technicianifproblem
persist.
LowpressureLEDis
constantlyilluminatedor
mattressisnotinflating
whilepumpisinoperation.
1. Checkforloosehose
connections.
2. CheckCPRvalve.
3. Checkforaircellsforholesor
tearsotherthanintended
designed.
1. Makesureconnectorsare
secured.
2. MakesureCPRvalveis
setto“CLOSE”position.
3. Replacedamagedaircellif
necessary.
4. Refertoqualifiedservice
technicianifproblem
persist.
Pumpisnoisy. 1. Makesurepumpisresting
againstsolidsurface.
1. Repositionthepump.
2. Refertoqualifiedservice
technicianifproblem
persist.


10
8.EMCRelatedNotifications
Guidanceandmanufacturer’sdeclaration–electromagneticemissions
The SaluteRDXis intended for use in the electromagnetic environment specified below. The
customer or the user of the SaluteRDX is responsible for making sure that it is used in such
environment.
EmissionstestComplianceElectromagneticenvironment–guidance
RFemissions
CISPR11
Group1 The SaluteRDXusesRFenergyonlyforits
internal function. Therefore, its RF emissions
areverylowandarenotlikelytocauseany
interferencewithnearbyelectronicequipment.
RFemissions
CISPR11
ClassB The SaluteRDXissuitableforuseinall
establishments, including domestic
establishmentsandthosedirectlyconnectedto
the public low‐voltage power supply network
that supplies buildings power for domestic
purposes.
Harmonicemissions
IEC61000‐3‐2
ClassA
Voltagefluctuations/
flickeremissions
IEC61000‐3‐3
Complies


























11





Recommendedseparationdistancesbetween
portableandmobileRFcommunicationsequipmentandtheSaluteRDX
The SaluteRDXisintendedforuseinanelectromagneticenvironmentinwhich radiated RF
disturbancesarecontrolled.ThecustomerortheuseroftheSaluteRDXcanhelpprevent
electromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobile
RFcommunicationsequipment(transmitters)andtheSaluteRDXasrecommendedbelow,in
accordancetothemaximumoutputpowerofthecommunicationsequipment.
Rated
maximum
outputpower
oftransmitter
W

Separationdistanceaccordingtofrequencyoftransmitter
m
150kHzto80
MHz
d=1,2 
80MHzto800
MHz
d=1,2 
800MHzto2,5GHz

d=2,3 
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance din metres (m) can be estimated using the equation applicable tothe
frequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterin
watts(W)accordingtothetransmittermanufacturer.
NOTE1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies
NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffected
byabsorptionandreflectionfromstructures,objectsandpeople.

12
Guidanceandmanufacturer’sdeclaration–electromagneticimmunity
TheSaluteRDXisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer
ortheuseroftheSaluteRDXisresponsibleformakingsurethatitisusedinsuchanenvironment.
ImmunitytestIEC60601
testlevelCompliancelevelElectromagneticenvironment– guidance
Electrostatic
discharge(ESD)
IEC61000‐4‐2
±6kVcontact
±8kVair
±6kVcontact
±8kVair
Floorsshouldbewood,concreteor
ceramictile.Iffloorsarecoveredwith
syntheticmaterial,therelativehumidity
shouldbeatleast30%.
Electricalfast
transient/burst

IEC61000‐4‐4
±2kVforpower
supplylines

±1kVfor
input/output
lines
±2kVforpower
supplylines

±1kVfor
input/output
lines
Themainpowerqualityshouldbethatof
atypicalcommercialorhospital
environment.
Surge
IEC61000‐4‐5
±1kVline(s)to
line(s)

±2kVline(s)to
earth
±1kVline(s)to
line(s)

±2kVline(s)to
earth
Themainpowerqualityshouldbethatof
atypicalcommercialorhospital
environment.

Interruptions
andvoltage
variationson
powersupply
inputlines


IEC61000‐4‐11
<5%UT
(>95%dipinUT)
for0,5cycle

40%UT
(60%dipinUT)
for5cycles

70%UT
(30%dipinUT)
for25cycles

<5%UT
(>95%dipinUT)
for5sec
<5%UT
(>95%dipinUT)
for0,5cycle

40%UT
(60%dipinUT)
for5cycles

70%UT
(30%dipinUT)
for25cycles

<5%UT
(>95%dipinUT)
for5sec
Themainpowerqualityshouldbethatof
atypicalcommercialorhospital
environment.IftheuseroftheSalute
RDXrequirescontinuedoperation
duringpowermaininteruptions,itis
recommendedthattheSaluteRDXbe
poweredfromanuninterruptiblepower
supplyorabattery.

Power
frequency
(50/60Hz)
magneticfield

IEC61000‐4‐8

3A/m


3A/m

Powerfrequencymagneticfieldsshould
beatlevelscharacteristicofatypical
locationinatypicalcommercialor
hospitalenvironment.
NOTE:UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.


13
Guidanceandmanufacturer’sdeclaration–electromagneticimmunity
TheSaluteRDXisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror
theuseroftheSaluteRDXisresponsibleformakingsurethatitisusedinsuchanenvironment.
Immunity
test
IEC60601test
level
Compliance
levelElectromagneticenvironment–guidance







Conducted
RF
IEC61000‐
4‐6


RadiatedRF
IEC61000‐
4‐3








3Vrms
150kHzto80
MHz


3V/m
80MHzto2,5
GHz









3Vrms



3V/m

Portable and mobile RF communications equipment
shouldbeusednoclosertoanypartoftheSalute
RDX, including cables, than the recommended
separation distance calculated from the equation
applicabletothefrequencyofthetransmitter.

Recommendedseparationdistance

d=1,2 

d=1,2 80MHzto800MHz

d=2,3 800MHzto2,5GHz

where Pisthemaximumoutputpowerratingofthe
transmitterinwatts(W)accordingtothetransmitter
manufacturer and distherecommendedseparation
distanceinmetres(m).

Field strengths from fixed RF transmitters, as
determinedbyanelectromagneticsitesurvey:

a. Should be less than the compliance level in each
frequencyrange.

b. Interference may occur in the vicinity of
equipmentmarkedwiththefollowingsymbol:



NOTE1:At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE 2:  These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionandreflectionfromstructuresobjectsandpeople.

a.Fieldstrengthsfromfixedtransmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthe
locationinwhichtheSaluteRDXisusedexceedstheapplicableRFcompliancelevelabove,theSalute
RDXshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additional
measuresmaybenecessary,suchasreorientingorrelocatingtheSaluteRDX.
b.Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

14
9.ExpectedServiceLife
TheSaluteRDXpumphasanexpectedservicelifeoftwoyears.To maintain the
condition of the pump, have the pump serviced regularly according to the schedule
recommendedbyCaremed.DoNOTuseunapprovedaccessoriesorattempttomodify,
disassembleorotherwisemisusetheSaluteRDXsystem.

10.Warranty
Prius Healthcare guarantees this equipment to be free from defects in material
andworkmanshipforupto12monthsfromthedateofdelivery.
All warranty work will be performed at the service address below, shipping
chargesprepaid.
AtManufacturersdiscretionweagreetoservice,repairorreplaceanyequipment
orpartfoundtobedefectiveatnocharge.
Thiswarrantyexcludesequipmentdamagedthroughshipping,tampering,
improper maintenance, carelessness, accident, negligence, misuse, or which has
been altered, repaired or dismantled other than with the manufacture’s written
authorization following approved procedures and performed by certified
technicians.
InnoeventshallPriusHealthcarebeliableforanydirect,indirect,consequential
damageorlossresultingfromtheuseofequipment.
Warrantyisnon‐transferrable.

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AL300274 V1.00
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PriusHealthcareUSA
4029TampaRoad,Suite4000C
Oldsmar,FL34677,USA
TEL:(813)854‐5464
FAX:(813)854‐5442