Download Salute RDX User Manual

SaluteRDX
3‐1Alternating
Anti‐DecubitusSystem
UserManual
PriusHealthcareUSA
4029TampaRoad,Suite4000C
Oldsmar,FL34677,USA
TEL:(813)854‐5464
FAX:(813)854‐5442
1505
Content
1.ThePurposeofthisManual.................................................................................1
2.ProductDescription................................................................................................1
MasterControlUnitFeatures
MattressFeatures
3.TechnicalData...........................................................................................................3
MasterControlUnit
SaluteMattressReplacement
SymbolDefinition
4.InstructionforProperUse....................................................................................4
5.Cleaning........................................................................................................................7
TheMattress
TheMasterControlUnit
ReplaceAirFilter
WasteDisposal
6.StorageandCare.......................................................................................................8
7.MaintenanceandTroubleshooting...................................................................9
8.EMCRelatedNotification...................................................................................10
9.ExpectedServiceLife...........................................................................................14
10.Warranty................................................................................................................14
IMPORTANTSAFEGUARDS
When using electrical products, especially when children are present, basic safety
precautionsshouldalwaysbefollowed,includingthefollowing:
*HOUSEHOLDUSEONLY*
CAUTION‐READALLINSTRUCTIONSBEFOREUSINGTHEAPPLIANCE
WARNING–Toreducetheriskofelectrocution:
1.Alwaysunplugproductimmediatelyafteruse.
2.Donotusewhilebathing.
3.Donotplaceorstoreproductwhereitcanfallorbepulledintoatuborsink.
4.Donotplaceinordropintowaterorotherliquids.
5.Donotreachforproductthathasfallenintowater.Unplugimmediately.
WARNING–Toreducetheriskofburns,electrocution,fireorinjurytopersons:
1. Theproductshouldneverbeleftunattendedwhenpluggedin.
2. Closesupervisionisnecessarywhentheproductisusedby,on,nearchildren
orphysicallychallengedindividuals.
3. Use the product only for its intended use as described in this manual. Do not
useattachmentsnotrecommendedbythemanufacturer.
4. Neveroperatethisproductifithasadamagedcordorplug,ifitisnotworking
properly,ifitishasbeendroppedordamaged,ordroppedintowater.Return
theproducttoaservicecenterforexaminationandrepair.
5. Keepthecordawayfromheatedsurfaces.
6. Neverblocktheairopeningofthisproductorplaceitonasoftsurface,suchas
abedorcouch,wheretheairopeningsmaybeblocked.Keeptheairopenings
freeoflint,hair,andothersimilardebris.
7. Neverdroporinsertobjectsintoanyopenings.
8. Donotuseoutdoors,operatewhereaerosol(spray)productsarebeingusedor
whereoxygenisbeingadministered.
9. DISCONNECTPOWERSUPPLYBEFOREOPENING.
10. Theproducthasnouserserviceablepartsexceptforfusereplacement.
11. Keepthepumpandtubing(including protectivesleeves) awayfromsources
ofliquidandopenflames.
12. Keepthepumpandtubingawayfromsharpobjects.
13. Ifpain,irritation,numbness,swelling,orrednessoccursdiscontinueuseand
contactahealthcareprofessional.
14. Powercable&pumpshallbeplacedatthefoot‐sideofthepatienttoprevent
anyriskofstrangulationduetocable.
1. ThePurposeofthisManual
Thisoperationmanualfocusesonthesetup,cleaningandroutinemaintenanceof
theSaluteRDX3‐1AlternatingAnti‐DecubitusSystem.Werecommendkeepingthis
manualavailabletoanswerquestionrelatedtothissystem.
2. ProductDescription
Salute RDX 3‐1 Alternating Anti‐Decubitus System is a pressure ulcer
preventionmattressreplacementsystemdesignedforuseinthehome,atanursing
facilityorinahospitalenvironment.Useofthissystemonastandardbedframeis
possible;howevertheuseofthissystemonabedframedesignedforahealthcare
environmentispreferred.
The system consists of an electronic control unit with a membrane control panel
andareplacementmattresscontaining18aircellsarrangedinatransversemanner.
TheaircellsaredesignedwithMicroLowAirLossfeaturetoassistinmanagingthe
moisture on a patient’s skin by allowing additional air to circulate on mattress
surface.AnotheruniquefeatureistheHappyHeel TMwhichprovidesindependent
comfortcontrolsettingsfortheheelsectionallowingimprovedpatientoutcomesas
wellasadditionalpatientcomfort.
MasterControlUnitFeatures
 3‐1alternationandstatictherapy
 IntuitiveLEDindicatorforfunctionstatus
 8adjustablecomfortsetting
 Visualandaudiblealarmsforlowpressureandpowerfailure
 HappyHeelTMprovidesextracomfortsettingsfortheheelsection
 Keypadlockoutfunction
 MaintenanceserviceLEDremainder
1
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.
SaluteRDXAirMattressTherapySystemisrecommendedforuseintheprevention
andtreatmentofdecubitus(pressure)ulcersstageI–III(mediumrisk).Forhigher
riskpatientspleasecontactPRIUSHealthcareUSAforadditionalproductofferingsto
addresshigherriskpatients.(813)854‐5464
Caution
Alternatingpressuretherapyisnotrecommendedforpatientswhohaveseriouspain
HealthcareUSAfor
orpain‐sensitivesymptom.InsuchcasespleasecontactPRIUS
additionalproductofferings.(813)854‐5464.
MattressFeatures
 Therapeutic micro low air loss helps manage moisture and provides
alternatingtherapytopreventandtreatpressureulcers
 Modularizeddesignallowsforeasycleaningandreplacementofaircells
 Highly vapor permeable and oversized pliable quilted nylon top cover
provideslowshear,frictionandmoistureprotection
 CPRquickreleaseforrapiddeflation
 Integrated power cable management assists in safety and organization of
powercables
 Cellincelldesignprovidesadditionprotectionforuppertorsoandsacrumin
theeventthereisalossofpower
 2” convoluted foam base provides additional safety in the event of a loss of
power
 Recommendedmaximumsafeworkingcapacityof500lbs
2
3.TechnicalData
MasterControlUnit
ModelName
ModelNo.
Size(inch)LxWxH
Weight(lbs)
CycleTime(min)
MinOperatingPressure
MaxOperatingPressure
MaxFlow‐rate
SaluteRDXControlUnit
FC‐PHR0032
13.5“x5.4“x8.3“
7.5
5,10,15,20min
12+/‐5mmHg
47+/‐5mmHg
≧6l/min
RatedVoltage
MaxCurrent
FuseRating
RatedFrequency
AC110‐120V
0.2Amp
1A250V
60Hz
ClassII,TypeBF
NotAP/APGtype
Classification
IngressofWater
Protection
ModeofOperation
IP21
Continuous
Operation:15°Cto35°C(59°Fto95°F)
Environment
(Temperature)
Storage:5°Cto60°C(41°Fto140°F)
Operation:30%to75%non‐condensing
Environment(Humidity)
Storage:30%to90%non‐condensing
IEC60601‐1,
CAN/CSAC22.2No.601.1,
Standard
IEC60601‐1‐11
IEC60601‐1‐2
MattressReplacement
ModelName
SaluteRDXAirMattress
ModelNo.
FM‐PHR0033
Size(inch)LxWxH
80“x36“x8“
Weight(lbs)
25.3
CellsNumber
18cells
CellsMaterial
NyloncoatedwithPU
CoverMaterial
Nylonwovenfabricw/PUcoatingfinish
BaseMaterial
WovenPolyesterfabricw/PVCbacking
3
SymbolDefinition
Type BF Protection Against Electronic Shock Class II Equipment Operating Instructions Caution, Consult accompanying documents Waste Disposal Alternating Current 4. InstructionforProperUse
1. Removethecontrolunitfromtheboxandhangitatthefootendofthebedusing
thehooksonthebackofthecontrolunit.
2. Plugthepowercordintoanappropriateoutlet.
3. Ifapplicableremovetheexistingmattressfromthebedframe.
4. Remove the Salute RDX replacement mattress from its packaging and place it
directlyonthebedframe.
5. Makesurethattheconnectinghoseispositionedatthefootofthebednearthe
controlunit.
6. Secure the mattress to the bed frame using the straps on the bottom of the
replacementmattresstopreventitfrommoving.
7. Connectthemattresshoseconnectortocontrolunit.Makesuretheconnectionis
secure.
8. ChecktheCPRvalvetomakesureitissetinthe“Close”position.
4
9. Turnonthecontrolunitusingthepowerswitchlocatedonthe sideoftheunit.
Selecttheautofirmcomfortcontroldialforquickinflation.
10.During the inflation process, the low pressure LED will be displayed until the
mattressisproperlyinflated,.Theinflationtimeofthemattresscantake30to40
minutes.Forquickerinflationaportableblowerunitisavailable.Pleasecontact
PriusHealthcareUSAforadditionalinformation,(813)854‐5464.
11.Whenthemattressisfullyinflated,setthedialinaccordancewiththepatient’s
sizeandweight.
 Runthesystemcheck.
 Thesystemisreadyforuse.

Nowthepatientcanbetransferredontothemattress.
5
AlarmFunction
The SaluteRDX3‐1AlternatingAnti‐DecubitusSystemis equipped with avisual
andaudiblealarmintheeventoflow pressure. Duringtheinitialinflationperiod
thesystemisinlowpressuremodeandthelowpressureLEDwillilluminate.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
inflateproperly.
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
alarmactivation.
Alarm Indication
Description
Indicates a loss of power.
Indicates low pressure.
Indicates service is required after 8760 hours of use.
Deactivationofaudiblealarm:
Switchthepumpoffthenbackon,todeactivatetheaudiblealarm.
CPRValve
The Salute RDX 3‐1 Alternating Anti‐Decubitus System is equipped with a CPR
emergencyvalvewhichfacilitatesarapiddeflationbyturningtheCPRvalvetothe
“OPEN”position.
6
5.Cleaning
TheMattress
Themattressshouldbecleanedweeklyusingadampsoftclothandmilddetergent.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
withcleancovers.
Coverscanbewashedandthermallydisinfectedinawashingmachinebyfollowing
theproceduresbelow:(NOTE:Neverusephenolbasedcleaningsolutions).
Industrial
Breakwash
Cold
10minutes
6minutes
Mainwash
60°C(140°F)
10minutes
Mainwash
70°C(158°F)
Extraction
2minutes
ColdRinse
Extraction
5minutes
Domestic
Pre‐wash
Cold
10minutes
MainWash
70°C(158°F)
Extraction
2minutes
ColdRinse
Extraction
5minutes
TumbleDryingorTunnelDryingisnotrecommended.
MattressCellscanbewipeddownwithasolutionofsodiumhypochlorite1000ppm
oranyothernon‐phenolbasedgermicidalcleaningsolution.
TheMasterControlUnit
Caution
SWITCHOFFTHEELECTRICALSUPPLYTOTHEPUMPANDDISCONNECTTHE
POWERCORDFROMTHEMAINSUPPLYBEFORECLEANINGANDINSPECTION
The pump unit should also be cleaned weekly using a damp soft cloth and mild
detergent.ThepumpcasingismanufacturedusingABSplastic,ifthecaseissoiledthe
pumpcanbewipeddownwithasodiumhypochloritesolutiondilutionof1000ppm
oranyEPAapprovedhospitalgradedisinfectant.
(NOTE:Donotusephenolbasedcleaningsolution).
Theairfiltershouldalsobecleanedandcheckedasoftenaspossibleataminimumof
every six months. The air filter can be accessed through the air filter cover on the
backoftheunit.Toremove,pinchthecenterofthefilterandpullingoutward.
7
ReplaceAirFilter
1. Remove air filter cover to access air filter. Pinch the center of air filter and
pulloutward,replacewithanewfilter.
2. Ifairfilteropeningissoileduseasoftbristlebrushtoremovedustanddried‐
onsoil.
NOTE:
1. Donotuseanyphenolbasedcleaningsolutions.
2. Switchofftheelectricalsupplytothepumpanddisconnectthepowercordfrom
themainsupplybeforecleaningandinspection.
WasteDisposal
This Product has been supplied by an environmentally conscious
manufacturerthatcomplieswiththeWEEE.
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
thisproductthroughyourrecyclingfacilityatitsendoflife.
6.StorageandCare
MasterControlUnit:
 Checkthepowercordandplugforabrasionsorexcessivewear.
 Pluginthecontrolunitandverifyairflowsfromtheunitshoseconnection
ports.
 Placeinplasticbagforstorage.
OverlayMattress:
 Checktheairmanifoldforkinksorbreaksandreplaceifnecessary.
 TurntheCPRvalvetotheopenpositionanddisconnecttheairtubesfromthe
controlunittoallowthemattresstoquicklydeflate.Startingattheheadend
ofthemattressrolltheunitupandusethebasemountstrapstosecure.
 Placemattressinaplasticbagofstorage.
Pleasefollowtherecommendedguidelinesbelowwhenthesystemisbeingstoredor
transportedtoanotherlocation:
Temperaturelimitations:
RelativeHumidity:
5°C(41°F)~60°C(140°F)
30%to90%
8
7.Maintenance&Troubleshooting
Daily maintenance is not required. This equipment should only be serviced by a
qualifiedandauthorizedtechnician.Forcommontroubleshootingtipspleasereferto
thechartbelow.
Symptom
Thepumpisnot
InspectionProcedures
1. Checkpowersource
functioning.
connection.
PossibleSolution
1. Connecttoproperpower
source.
2. Checkforblownfuse.
2. Replacefuse.
3. Refertoqualifiedservice
technicianifproblem
persist.
LowpressureLEDis
constantlyilluminatedor
1. Checkforloosehose
connections.
1. Makesureconnectorsare
secured.
mattressisnotinflating
2. CheckCPRvalve.
whilepumpisinoperation.
3. Checkforaircellsforholesor
setto“CLOSE”position.
tearsotherthanintended
3. Replacedamagedaircellif
designed.
2. MakesureCPRvalveis
necessary.
4. Refertoqualifiedservice
technicianifproblem
persist.
Pumpisnoisy.
1. Makesurepumpisresting
againstsolidsurface.
1. Repositionthepump.
2. Refertoqualifiedservice
technicianifproblem
persist.
9
8.EMCRelatedNotifications
Guidanceandmanufacturer’sdeclaration–electromagneticemissions
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.
Emissionstest
RFemissions
Compliance
Electromagneticenvironment–guidance
Group1
The Salute RDX uses RF energy only for its
internal function. Therefore, its RF emissions
CISPR11
are very low and are not likely to cause any
interferencewithnearbyelectronicequipment.
RFemissions
ClassB
The Salute RDX is suitable for use in all
establishments,
CISPR11
Harmonicemissions
domestic
establishmentsandthosedirectlyconnectedto
ClassA
the public low‐voltage power supply network
IEC61000‐3‐2
Voltagefluctuations/
including
that supplies buildings power for domestic
Complies
purposes.
flickeremissions
IEC61000‐3‐3
10
Recommendedseparationdistancesbetween
portableandmobileRFcommunicationsequipmentandtheSaluteRDX
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
electromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobile
RFcommunicationsequipment(transmitters)andtheSaluteRDXasrecommendedbelow,in
accordancetothemaximumoutputpowerofthecommunicationsequipment.
Rated
Separationdistanceaccordingtofrequencyoftransmitter
maximum
m
outputpower
150kHzto80
80MHzto800
800MHzto2,5GHz
oftransmitter
MHz
MHz
W
d=1,2
d=1,2
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
frequencyofthetransmitter,wherePisthemaximumoutputpowerratingofthetransmitterin
watts(W)accordingtothetransmittermanufacturer.
NOTE1:At80MHzand800MHz,theseparationdistanceforthehigherfrequencyrangeapplies
NOTE2:Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffected
byabsorptionandreflectionfromstructures,objectsandpeople.
11
Guidanceandmanufacturer’sdeclaration–electromagneticimmunity
TheSaluteRDXisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomer
ortheuseroftheSaluteRDXisresponsibleformakingsurethatitisusedinsuchanenvironment.
IEC60601
testlevel
Electrostatic ±6kVcontact
discharge(ESD) ±8kVair
IEC61000‐4‐2
Immunitytest
Compliancelevel
±6kVcontact
±8kVair
Electromagneticenvironment–
guidance
Floorsshouldbewood,concreteor
ceramictile.Iffloorsarecoveredwith
syntheticmaterial,therelativehumidity
shouldbeatleast30%.
Electricalfast
transient/burst
IEC61000‐4‐4
Surge
IEC61000‐4‐5
Interruptions
andvoltage
variationson
powersupply
inputlines
IEC61000‐4‐11
±2kVforpower
supplylines
±1kVfor
input/output
lines
±1kVline(s)to
line(s)
±2kVline(s)to
earth
±2kVforpower
supplylines
±1kVfor
input/output
lines
±1kVline(s)to
line(s)
±2kVline(s)to
earth
Themainpowerqualityshouldbethatof
<5%UT
(>95%dipinUT)
for0,5cycle
40%UT
(60%dipinUT)
for5cycles
70%UT
(30%dipinUT)
for25cycles
<5%UT
(>95%dipinUT)
for5sec
3A/m
<5%UT
(>95%dipinUT)
for0,5cycle
40%UT
(60%dipinUT)
for5cycles
70%UT
(30%dipinUT)
for25cycles
<5%UT
(>95%dipinUT)
for5sec
3A/m
Themainpowerqualityshouldbethatof
atypicalcommercialorhospital
environment.
Themainpowerqualityshouldbethatof
atypicalcommercialorhospital
environment.
atypicalcommercialorhospital
environment.IftheuseroftheSalute
RDXrequirescontinuedoperation
duringpowermaininteruptions,itis
recommendedthattheSaluteRDXbe
poweredfromanuninterruptiblepower
supplyorabattery.
Power
Powerfrequencymagneticfieldsshould
frequency
beatlevelscharacteristicofatypical
(50/60Hz)
locationinatypicalcommercialor
magneticfield
hospitalenvironment.
IEC61000‐4‐8
NOTE:UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
12
Guidanceandmanufacturer’sdeclaration–electromagneticimmunity
TheSaluteRDXisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror
theuseroftheSaluteRDXisresponsibleformakingsurethatitisusedinsuchanenvironment.
Immunity
IEC60601test
Compliance
test
level
level
Conducted
RF
IEC61000‐
4‐6
RadiatedRF
IEC61000‐
4‐3
3Vrms
150kHzto80
MHz
3V/m
80 MHz to 2,5
GHz
Electromagneticenvironment–guidance
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
applicabletothefrequencyofthetransmitter.
Recommendedseparationdistance
d=1,2
d=1,2
80MHzto800MHz
d=2,3
800MHzto2,5GHz
where Pis the maximum output power rating of the
transmitterinwatts(W)accordingtothetransmitter
manufacturer and dis the recommended separation
distanceinmetres(m).
Field strengths from fixed RF transmitters, as
determinedbyanelectromagneticsitesurvey:
a. Should be less than the compliance level in each
frequencyrange.
b. Interference may occur in the vicinity of
equipmentmarkedwiththefollowingsymbol:
3Vrms
3V/m
NOTE1:At80MHzand800MHz,thehigherfrequencyrangeapplies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorptionandreflectionfromstructuresobjectsandpeople.
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,anelectromagneticsitesurveyshouldbeconsidered.Ifthemeasuredfieldstrengthinthe
locationinwhichtheSaluteRDXisusedexceedstheapplicableRFcompliancelevelabove,theSalute
RDXshouldbeobservedtoverifynormaloperation.Ifabnormalperformanceisobserved,additional
measuresmaybenecessary,suchasreorientingorrelocatingtheSaluteRDX.
b.Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.
13
9.ExpectedServiceLife
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
recommendedbyCaremed.DoNOTuseunapprovedaccessoriesorattempttomodify,
disassembleorotherwisemisusetheSaluteRDXsystem.
10.Warranty
 Prius Healthcare guarantees this equipment to be free from defects in material
andworkmanshipforupto12monthsfromthedateofdelivery.
 All warranty work will be performed at the service address below, shipping
chargesprepaid.
 AtManufacturersdiscretionweagreetoservice,repairorreplaceanyequipment
orpartfoundtobedefectiveatnocharge.
 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.
 InnoeventshallPriusHealthcarebeliableforanydirect,indirect,consequential
damageorlossresultingfromtheuseofequipment.
 Warrantyisnon‐transferrable.
14
PriusHealthcareUSA
4029TampaRoad,Suite4000C
Oldsmar,FL34677,USA
TEL:(813)854‐5464
FAX:(813)854‐5442
AL300274 V1.00