PDF Keeler Pulsair Desktop

Transcription

Instructionsforuse
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Contents
1. CopyrightandTrademarks.............................................p3
10. Measurementprocedures............................................p16
2. Introduction....................................................................p4
10.1Preparingthedevice............................................p16
3. Symbols...........................................................................p5
10.2Preparingthepatient...........................................p17
4. Safety...............................................................................p6
10.3Takingthereading...............................................p18
4.1DeviceClassification.................................................p6
11. Displayexamples..........................................................p19
4.2Warningsandcautions............................................p6
12. Printing..........................................................................p20
5. Cleaninginstructions......................................................p7
13. Replacingtheprinterpaper........................................p21
6. Powersupplyassembly..................................................p8
14. Usermenuoptions.......................................................p22
7. Mounting........................................................................p9
15. Calibration,maintenanceandinspection...................p23
8. Tonometrypressurevariationsinthehumaneye......p10
16. Specificationsandelectricalratings............................p25
9. Namesofcontrolsandcomponents...........................p11
17. Accessoriesandwarranty.............................................p31
18. Contact,packaginganddisposalinformation...........p32
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As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice.
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2
1. Copyright and Trademarks
Theinformationcontainedwithinthismanualmustnotbe
Description of the product
reproducedinwholeorpartwithoutthemanufacturer’sprior
ThePulsairDesktopTonometerisindicatedformeasuring
writtenapproval.
intraocularpressurewithoutcontactingtheeyetoaidinthe
screeninganddiagnosisofglaucoma.
Themanufacturerreservestherighttomakechangesto
specificationsandotherinformationcontainedinthisdocument
Itisan“airpuff”TonometerdesignedtoaccuratelymeasureIntra
withoutpriornotice.
OcularPressure(IOP)withoutmakingcontactwiththesurfaceof
theeye.
PulsairDesktop™isaregisteredTrademarkof
KeelerLimited2007.
Airimpulsetonometryisavariantofthegeneralapplanation
tonometryinwhichaportionofthecorneaisflexedby
Copyright©KeelerLimited2007.
mechanicalstimuliinwhichtheforce/pressurerequiredto
producetheflexingeffectisrelatedtotheintraocularpressure.
PublishedintheUK2009.
Theairpufftechniquerequiresdirectingacalibratedquantized
packetofairtowardsthecentralportionofthecornea,andthe
detectionofthepre-defineddeformationofthecorneathrough
opticalmeansandreflectionsfromthecornealsurface.
Please read and follow these instructions carefully.
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3
2. Introduction
ThankyouforpurchasingtheKeelerPulsairDesktop.
Theproducthasbeendesignedandmanufacturedto
ensurethatyouwillenjoymanyyearsof
troublefreeandsafeuse.
PleasefollowtheUserInstructionsto
ensureoptimumperformance.
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3. Symbols
ReaduserinstructionsforWarnings,Cautionsand
additionalinformation
TheCEmarkonthisproductindicatesithasbeen
0088
Powerinputport
On/Off
testedtoandconformswiththeprovisionsnoted
withinthe93/42/EECMedicalDeviceDirective
Doubleinsulated
TypeBFprotectionsagainstshock
Consultinstructionsforuse
Colouradjustment
Brightnessadjustment
Contrastadjustment
Fragile
Manufacturersnameandaddress
Keepdry
USBtransferport
Thiswayup
Materialsuitableforrecycling
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4. Safety
4.1 Device Classification
CERegulation93/42EEC:Class2a
• Theproducthasbeendesignedtofunctionsafelywhenatan
FDA:ClassII
ambienttemperaturebetween+10ºCand+35ºC.
• Keepoutofthereachofchildren.
4.2 Warnings and cautions
Caution
• Topreventcondensationfromforming,allowinstrumentto
cometoroomtemperaturebeforeuse.
Warning
• Donotuseiftheproductisvisiblydamagedandperiodically
inspectforsignsofdamage.
• AccuracyofIOPmeasurementsisknowntobeaffectedby variationsandchangesincornealrigidityduetodifferencesin
cornealthickness,intrinsicstructuralfactorsorcorneal
• Donotuseinthepresenceofflammablegases.
refractivesurgery.Itisrecommendedthatthesefactorsare • Thisproductshouldnotbeimmersedinfluids.
consideredduringIOPmeasurement.
• Donotfitmainspoweradapterintoadamagedmains
• Keelerrecommendstheuseofdisposablehygienicchinrest outletsocket.
tissuesonthechinrestbeforethepatientsplacetheirchin
• Routepowercordssafelytoeliminateriskoftrippingor
onit.
damagetouser.
• Thisproductshouldbeusedinaroomwithsubduedlighting
• Thisequipmentshouldonlybeusedbytrainedpersonnel.
• BeforeusingthePulsairDesktop,pressthe'Clear/Demo'
USAFederallawrestrictsthisdevicetosalebyororderofa
buttonfor1secondtodispelanyminuteparticlesofdustor
physician.
moisturewhichmayhavesettledwhilsttheinstrumentwas
• OnlyuseapprovedKeelerpowersupplyEP29-32777or
notinuse.
instrumentmaymalfunction.
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5. Cleaning instructions
Onlymanualnon-immersioncleaningasdescribedshould
beusedforthisinstrument.Donotautoclaveorimmersein
cleaningfluids.Alwaysdisconnectpowersupplyfromsource
beforecleaning.
a Wipetheexternalsurfacewithacleanabsorbent,non-
sheddingclothdampenedwithawater/detergentsolution
(2%detergentbyvolume)orwater/isopropylalcohol
solution(70%IPAbyvolume).Avoidopticalsurfaces.
b Ensurethatexcesssolutiondoesnotentertheinstrument.
Usecautiontoensureclothisnotsaturatedwithsolution.
c Surfacesmustbecarefullyhand-driedusingacleannon-
sheddingcloth.
d Safelydisposeofusedcleaningmaterials.
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6. Power supply assembly
Set Plug
Replacetheblankingplatewiththeappropriatemainsplug
adapterifrequired,oruseIEC60320TYPE7connector
(notsupplied).
IEC 60320 TYPE 7 connector
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7. Mounting
YourPulsairDesktopisdesignedtobeusedonasturdyflat
surface,forexampleamedicalinstrumenttableorapurpose
designedrefractionsystemtabletop.
ChoosecarefullytheintendedlocationforyourPulsairDesktop
withparticularconsiderationtohealthandsafetyaspects,for
exampletheroutingofthepowerlead,andit’spositionin
regardtotheuserandthepatient.
YourPulsairDesktophasfourantisliprubberfeet,ensurethese
arelocatedwellwithintheedgeofyourintendedflatsurfaceto
ensurethereisnopossibilityofthePulsairbecomingdislodged
andcausinginjurytoauserorpatient.
YourPulsairDesktophasanadjustablechinrest,howeverwe
recommendthattoensuremaximumpatientcomfortyouuseit
onaheightadjustabletablethatallowswheelchairaccessforany
wheelchairboundpatients.
Anti slip
rubber feet
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8. Tonometry, pressure variations in the human eye
TheKeelerPulsairDesktopmeasuresintra-ocularpressureby
automaticallyreleasingagentlepuffofairontothecornea.
Thisisknownasanevent.
AsinglereadingcansometimesbemisleadingastheIOPwill
varyasaresultofpulse,respiratoryanddiurnalfluctuations.In
additionblinking,squeezing,fluidintake,physicalactivity,body
positionandeventhedirectionofgazecaninfluenceIOP.
Upto4readingsmayberequiredinordertoreducetheimpact
ofthesevariantstoaconstantIOP.
PulsairDesktopsoftwarewillrecognisethereadingsandgive
asoundnotificationwhentwoconsecutivereadingsare+/-
1mmHgofeachotherindicatingthatfurthermeasurementsmay
notberequired.
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9. Names of controls and components
1. Travellinglock
ThePulsairDesktopisfittedwithatravellinglocktoprotect
themovingpartsfromdamagewhenintransitorwhenthe
devicemaybesubjecttosuddenmovementorshock.
Toreleasethetravellinglockrotateitcounterclockwiseuntilthe joystickassemblyisfreetomove.
Tolockthemovingsectioninplace,alignthemovingupper
sectionwiththebaseunitandcarefullyscrewthetravellinglock clockwiseuntilitisfirmlylocated.
Note – do not over tighten the travelling lock.
2
2. Chinrestandchinrestheightadjuster
Rotatethechinrestadjustertoincreaseordecreasethe
heightofthechinrestuntilthepatientsoutercanthusisinline
withtheindicatorlineonthechinrestverticalbar.
1
3
3. On/Offpushbutton
OnpressingtheOn/Offbutton,theinstrument
willbeswitchedonandreadyforuse.The
displaywillprogressquicklythroughthe
followingstagesduringsysteminitialisation.
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5. Motionsensitivewakeupmechanism
K E E L E R
S T A R T I
P U L S A
I
R
N G
O K
Whenthesystemisreadytouse,thedisplaywillreadL:Readyor
R:Readydependingonwhetherthetonometerisinposition
totestthelefteyeortherighteye.
R
: R E A D Y
Rindicatesitisintherighteyeposition–thedisplaycouldalsoread
ThePulsairDesktopisequippedwithamotionsensor.Upon movingtheplatformfromlefttorightorviceversa,themotion
sensitiveswitchisactivatedtostartthepumpandtherestofthe
systemfromStandbymodesothatitisreadyformeasurement
use.Theinstrumentwillgothroughallthedisplaysasper section3.Aftertwominutesofinactivitythesystem automaticallyswitchesofftosaveenergy.
6. Clear/Demobutton
C L E A R I N G
L
:
R E A D Y
4. Start/Stopbutton
PressingthisbuttonwhilethePulsairDesktop
isrunningwillstopthepumpandputthe
systemintostandbymode,thedisplaywill
showStandby.TheStart/Stopbuttonwillresetthememorybuffer,
clearingallreadingsstored.Pressingthisbuttonwhiletheunitis
onstandby,thePulsairDesktopwillstartwiththepumprunning
andthesystemisinitialisedreadyforuse.Theinstrumentwillgo
throughallthedisplaysaspersection3.
PressingtheClear/Demobutton
momentarilyclearsallrecordsof
previousreadingsandtheinstrumentis
settoitsdefaultsetting.Ifthisbuttonispressedandheld
formorethanasecond,theinstrumentinitialisesandpuffs
ademopuffinordertodemonstratetothepatientthe
softnessoftheairpuff.
D E M O
P U F F
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9. USBtransferport
7. Print/Menubutton
Thisisusedfortransferring
IOPdatatoanexternaldevice
integratedprinterandsendthedatato
suchasapersonalcomputer
theUSBdataport.Ifthisbuttonispressed andforusebyaqualified
andheldformorethanasecond,auser
technicianwhen
selectablemenuoptionisentered.
calibratingthePulsair
Desktoporperforming
asoftwarerevision.
PressingthePrint/Menubutton
momentarilywillprinttheresultsonthe
N O
7
D A T A
11
8
9
10
10.Powerinputconnection/
P R I N T I N G
disconnection
Toconnect,insertthelowvoltagepowerleadintothe
8. EasyPulseButton
powerinputsocket.Todisconnect,removethelowvoltage
powerleadfromthepowerinputsocket.
E A S Y
P U L S E
Pressingandholdingthisbuttonforover
11.Joystick
asecondactivatesthe‘EasyPulse’mode.
Therotatingjoystickcontrolstheelevationofthe Thisenablestheinstrumenttofire
measurementheadandbackfrontmovementsofthemoving
intheeventofdifficultiesinfiring,forexample,witha
uppersectionofthePulsairDesktop.
damagedorscarredcornea.Thisactionisaccompaniedby
soundandanadditionalmomentaryindicationonthedisplay.
Onpressinganyotherbuttonorchangingtheeye,the
instrumentresetstonormalmode.
8
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12.Printercover
Accesstotheprinterpaperisviathiscover,useyourfingerin
theliponthetopofthecoverandgentlypulltowardsyouto
opentheprintercover.
13.Alignmentscreen
Thealignmentscreenallowstheusertovisualisethe
patient’seyesinordertocorrectlyaligntheinstrument
withthecentreofthecorneapriortomeasurement.
Alignmentisperformedusingthemovingpartofthe
PulsairDesktopandthejoystickforfinalalignment.
ThePulsairDesktopwillfireautomaticallywhencorrectly ositionedandaligned.Seesection10fordetailedinstructions
p
onthealignmentprocess.
13
14
14.Alignmentscreenadjustment
controlwheels
RefertoSection3forinformation
onthefunctionofthesethree
controlwheels.
12
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15.Measurementdisplayscreen
Measurementdisplayscreen–ThisscreenwilldisplaytheEye
measured,theaveragereadingandindividualreadings
fromeithertheleft(L)andright(R)eyes.Leftandright detectionisautomatic.
R :
1 6
:
1 6
1 6
1 6
b)
>25: This is shown when applanation is detected
with soft-puff and the reading is greater than
15
25mmHg, in this case the instrument displays >25
and switched to hard puff. The instrument shall
stay in hard puff until two consecutive readings are
less than 20mmHg.
c)
>50: This is shown when the reading is greater than 50mmHg, in which case
no valid reading is displayed. (Signified by long sound)
1 6
Afterthefirstreadingistakenthedisplayshowsthe
measuredIOP.Aftereachoftheconsecutivereadingsare takenthedisplayshowstheindividualreadingandthe
averageofuptothelastfour4readingspereye.
InadditiontoIOPreadings,thePulsairDesktopalsodisplaysa
numberofmessagesonthecharacterdisplaywhena
measurementisnotdetectedforanumberofreasons.In suchcases,thedisplaymayreadasfollows:
a)
< 5: This is shown when the reading is lower than 5mmHg, in which case no
valid reading is displayed. (Signified by long sound)
Note: The displayed dummy average is rounded to the nearest whole number or
displayed to one decimal place depending on the user setting accessed via the menu.
Thedisplayedrunningaverageisbasedontheactualreadings
whicharetakentoonedecimalplace.Forexample,readingsof
15.4,16.3,14.2and16.9areaveragedbyaddingthemtogether
whichequals62.8anddividingbythenumberofreadingstaken,4.
Thisgivesafinalfigureof15.7,or16dependingonusersettings.
Pleasenoteindependentreadingsaredisplayedaswholenumbers.
Whenalltherequiredreadingshavebeentakenthefigure
displayedistheIOPthatisrecordedforthepatient.Whentwo
consecutivereadingsarewithin1mmHg
anaudiblesoundwillbeheardindicating
thatsufficientreadingsmay
havebeentaken.
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10. Measurement procedures
3
10.1 Preparing the device
1. Pluginthepowersupplycordtotheinstrument.Thepowersocketis
locatedontherighthandsideoftheinstrument.
6
2. Turntheinstrumentonusingtheon/offpushswitchlocatedonthe
frontoftheinstrument.Toinitialisetheinstrumentreadyforuse.
5
3. Removetheprotectivedustcapfromthepufftube.
4. Unscrewthetransitlockifsecured.
5. UsingthejoystickbringthemovingpartofthePulsairDesktopback
towardsyouandacrosstotheleft(tomeasuretherighteyefirst).
4
2
1
6. BeforeusingthePulsairDesktop,pressthe'Clear/Demo'buttonfor
1secondtodispelanyminuteparticlesofdustormoisturewhichmay
havesettledwhilsttheinstrumentwasnotinuse.
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10.2 Preparing the patient
Before taking a reading you should:
BeforeusingthePulsairDesktopyoushouldmakeyourpatient
1. Askthepatienttoblinktoensureagoodandreflectivetearfilm.
feelateaseandensuretheyarelocatedinanoptimumreading
location,preferablywiththeirheadsupported.Thisisbecause
2. Ensurethepatientandinstrumentopticsarenotpositioned
apprehensionandnervousnessmayadverselyaffectthereadings
underdirectlighting(i.e.spotlightsorsunlight).
obtained.Followthepointsoutlinedbelowtoachievethis:
3. Ensurethepatient’seyesarefullyopened.Thishelpsto
1. Ensurethatthepatientiscomfortableandinarelaxed
position.
preventsqueezing,wherethepatientunconsciouslytenses
theireyelidsandincreasesIOP.
2. Askthepatienttoremovetheircontactlensesorspectaclesif
4. Throughoutthereadingprocess,youshould:
Allowthepatienttoblinkatintervalsinordertomaintain
thecornealtearfilm.
wornandtoblinkandbreathenormally.
3. Inordertoreassurethepatient,youcandemonstratethe procedure,usingtheDemobutton,onthebackofthe
patient’shandpriortotakingareading.
4. Placedisposablechinresttissueonthechinrest.
Askthepatienttoplacetheirheadonthechinrest.
4
5
5. Adjustthechinrestheightsothattheoutercanthusis
alignedwiththemarkeronthechinrestverticalsupport.
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10.3 Taking the reading
1. Holdingthejoystick,movewiththeotherhandthemovingpartof
thePulsairDesktopuntilthepatient’seyetobemeasuredisvisibleand centralonthealignmentvideoscreen.Heightadjustmentisobtainedby
rotatingthejoystick.Ifthereisinsufficienttravelre-checkthepatients headheightinthechinrestandtryagainusingthejoystick
2. Carefullymovethetonometertowardsthepatientuntiltheexternaleye
imagebecomesthecrosshairsalignmenttarget
3. Usingthejoystick,focusthecrosshairalignmenttargetuntilthecorrect
focusedpositiontriggersthetonometertofireautomatically.
1
4. RemaininthefiringpositionuntilthePulsairstopsreading,afterfour readingspereyearetaken.ThePulsairDesktopwillindicatewithashort
beepwhensufficientreadingsmayhavebeentakeni.e.whentwo
successivereadingsarewithin+/-1mmHgofeachother.
2
5. Ifareadingisrecordedasanoneventorbadevent,abadeventlongtone
willbeheard.
6. Thefirstreadingwillbethemeasuredvalue;successivereadingswilldisplay
therunningaverageIOP.Outlyingorspuriousreadingswillautomaticallybe
excludedfromthecalculation.
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11. Display examples
Theunitwilldisplay‘STANDBY’whenthepowerison.
K T
E AE R
L T
E IR N G
P U
S
. L. S. A
. .I
R
.
.
.
Whenapressure(IOP)ofgreaterthan25mmHgisdetected,the
unitwilldisplay>25.Whenapressure(IOP)ofgreaterthan
S T A R T I
N G
50mmHgisdetected,theunitwilldisplay>50.Ineachcase,the
Theunitwilldisplay‘STARTING’whilethesysteminitialises.
puffintensitywillautomaticallybeincreasedfromthesoftpuff
tothenormalpufflevelforsubsequentmeasurements.Inthese
casestheuserdoesnotneedtoresettheinstrument.
O K
R :
1 6
:
1 6
1 6
1 6
1 6
R U N
S E L F
T E S T ?
S E L F T E S T
R U N N I
Individualreadings,alongwiththerunningaverage(ontheleft
handsideofthedisplay)ofmeasurementstakensofarwillbe
displayed.Thedecimalpointintherunningaverageisselectable
bytheuser.i.e.’16.5’:ifthexx.xsettingisselectedintheSET
IOPFormator16isdisplayedifxxisselectedthroughthemenu
system(refertosection14).Outlyingorspuriousreadingswill
automaticallybeexcludedfromthecalculation.
N G
Aselftestprogramcanberunfordiagnosticpurposeby
selectingtheMenuOption.Thedisplaywillshowrunselftest.
BypressingtheClear/Demobuttonselftestisenteredandthe
displaywillshowselftestrunning,andthiswillrunfor45
seconds.Attheendofthetesttheresultingdatais
senttotheprinterandthedisplay
iscleared.
Whenapressure(IOP)oflessthan5mmHgisdetected,theunit
willdisplay‘<5READAGAIN’.
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12. Printing
Theresultscanbeprintedbypressingtheprintbuttonatany
time.Printingtheresultsdoesnotcleartheprintmemorybuffer.
USB data out
Pressingtheprintbuttonsendsaflatfileto
theusbportinthefollowingformat:
[R]:xx,xx,xx,xx,[xx.x]
[L]:xx,xx,xx,xx,[xx.x]
PRINT
BUTTON
Thisdatamaybeabletobeimported
intootherapplications,fordetailsof
howtoperformthispleaseconsultyour
thirdpartyprogramsupportteam.
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13. Replacing the printer paper
1. Accesstotheprinterpaperisviatheprintercover,useyour
fingerintheliponthetopofthecoverandgentlypull
towardsyoutoopentheprintercover.
Removetheemptypaperroll.
2. Placethenewrollofpaperintothepaperholder,makingsure
thefreeendislooseatthetopoftheroll,otherwiseitwon’t
print.
1
3. Feedthefreeendofpaperthroughthegapinthecover.
4. Closethecover.
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14. User menu options
1. Withtheunitswitchedon,pressandholdthe‘print/menu’button
Menuoption
Display
Changeoptions
BuzzerControl
BUzzERON
ON/OFF
2. ThedisplaywillshowthefirstMenuOption(BuzzerControl)and IOPFormat
DISPLAYXX
XX/XX.X
DisplayScreen
CONTRAST0
0-20
FullSelfTest
RUNSELFTEST?
RUNNINGSELFTEST
for>3secondtoentertheusermenu.
thecurrentselection(ie.[BUzzERON]or[BUzzEROFF])
3. Pressingthe‘clear/demo’buttonfor<1second,cyclesthroughthe
userChangeOptions(shownintable.)
4. Pressingthe‘print/menu’buttonfor<1secondmovesyouforward
tothenextMenuOption(shownintable),inthiscasetheDesktop
Level.
5. Usethe‘clear/demo’buttontomakeyourpreferredselection.
6. Continuetorepeatsteps4and5until‘OK’isdisplayed.YourPulsair
Desktopisnowreadytousewithyourpreferredsettings.
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15. Calibration, maintenance and inspection
Clean the puff tube lens on a weekly basis:
1. MoistenacottonbudwithIsopropylAlcohol.
2. Movethetipofthebudaroundthelensinacircularmotion.
3. Afteronecirclethebudshouldbediscardedtoavoid
smearingonthelens.
4. Lookatthepufftubelensfromthepatient’sside,iftracesof
tearfilmcanstillbeseen,repeatabovestepsuntilclear.
Note: Care should be taken not to damage the Puff Tube
assembly during cleaning.
Caution
Neveruseadrycottonbudortissuetocleanthepufftubelens.
Neveruseasiliconeimpregnatedclothortissuetocleanthe
pufftubelens.
External cleaning
Keeptheunitfreeofdust.
Keepthechinrestandforeheadrestclean.
Regular inspection
Inspectyourpowersupplyunitandcablefordamageregularly.
Beforeinspecting,disconnectthepowersupplyfromthePulsair
Desktopandthemains.
Iftheouterinsulationofthecableappearstobedamaged
discontinueuseimmediately.Contactyour
localdealerforareplacement.
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23
15. Calibration, maintenance and inspection
General
Servicing and calibration
Keeptheinstrumentfreefromdust.
KeelerrecommendsanannualcalibrationfortheTonometer.
Donotmodifythisequipmentwithoutauthorisationofthe
Iftheunitistoremainunusedforanylengthoftime,pressthe
manufacturer.
On/Offpush button switchtoOffandremovethepowersupply.
Usethedustcovertoprotecttheunit.
ThismustbeperformedbyanauthorisedPulsairservicecentre
ordistributor.Theunitperformsaselffunctioncheckwhen
switchedonandwillindicateifafaultisfound.
Therearenouserserviceablepartsinthisinstrument.Service
manualswillbeavailabletoauthorisedKeelerservicecentres
andKeelertrainedservicepersonnel.
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16. Specifications and electrical ratings
Dimensions
475x410x245mm(HxDxW)
Weight
16kg
Calibratedrange
5mmHgto50mmHg
Repeatability(Average <5%
coefficientofvariation)
Accuracy
+/-5mmHg(95%confidencelevel)*
Workingdistance
20mmfromsurfaceofpatient’scorneatofrontsurfaceoffirstlens.
Thisequatestoanominaldistanceof15mmfromthefrontofthepufftube
shroudtothefrontsurfaceofthepatient’scornea
Displayedscale
Singleline16characteralphanumericdisplay
Illuminationsystem
LEDinfrared
Complieswith
ElectricalSafety(Medical)BSEN60601-1:2006
ElectromagneticcompatibilityEN60601-1-2:2007
Ophthalmicinstruments-fundamentalrequirementsandtestmethodsISO15004-1:2006
OpticalradiationhazardISO15004-2:2007
PowerSupplyUnit
Switchmode,(110–240V)+/-10%multiplugtypecomplianttoEN60601-1
EN61000-6-2,EN61000-6-3
Powersupplyoutput 30VA(12VDC2.5A)
Frequency
50/60Hz
Environment
Use:+10°Cto+35°C
Storage:-10°Cto+55°C
Transport:-15°Cto+60°C
*In house trial carried out on 20 participants
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25
Itiswellestablishedthatexposureoftheeyetointenselight
sourcesforextendedperiodsoftimeposesariskofretinalphotic
injury.Manyophthalmicinstrumentsilluminatetheeyewith
intenselight.ThelightlevelsonthePulsairhavebeensetatthe
lowestlevelpossible.
Novisibleretinallesionshavebeenidentifiedasaresultofusing
Pulsairtonometers,however,youngchildrenandpersonswith
diseasedeyesmaybeatahigherrisk.Theriskmayalsobeslightly
increasedifthepersonbeingexaminedhashadanyexposurewiththe
sameinstrumentoranotherophthalmicinstrumentusinganintense
visiblelightsourceduringtheprevious24hours.Thiswillapply
particularlyiftheeyehasbeensubjectedtoretinalphotography.
Red LED
White LEDs
Parameter
Wavelength(nm)
ValueMeasured
Limit
Units
Parameter
Wavelength(nm)
ValueMeasured
Limit
Units
ES-CL
250-400
8.98E-4
0.4
µWcm
ES-CL
250-400
4.53E-5
0.4
µWcm-2
EUV-CL
360-400
8.11E-7
1
mWcm-2
EUV-CL
360-400
4.85E-8
1
mWcm-2
EA-R
305-700
3.52E-2
220
µWcm-2
EA-R
305-700
0.24
220
µWcm-2
EIR-CL
770-2500
8.42E-3
20
mWcm-2
EIR-CL
770-2500
1.78E-4
20
mWcm-2
EVIR-R
380-1400
1.23E-1
0.7
Wcm-2
EVIR-R
380-1400
2.69E-5
0.7
Wcm-2
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26
TheKeelerDesktoptonometerisamedicalelectricalinstrument.Theinstrumentrequiresspecialcareconcerning
electromagneticcompatibility(EMC).ThisSectiondescribesitssuitabilityintermsofelectromagneticcompatibilityof
thisinstrument.Wheninstallingorusingthisinstrument,pleasereadcarefullyandobservewhatisdescribedhere.
1.Portableormobile-typeradiofrequencycommunicationunitsmayhaveanadverseeffectonthis
instrument,resultinginmalfunctioning.
Guidanceandmanufacturer’sdeclaration–electromagneticemissions
TheKeelerDesktopisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomerorusershouldassurethat
itisusedinsuchanenvironment.
Emissionstest
Compliance
Electromagneticenvironment-guidance
RFemissions
CISPR11
Group1
TheKeelerDesktopusesRFenergyonlyforitsinternal
function.Therefore,itsRFemissionsareverylowandare
notlikelytocauseanyinterferenceinnearbyelectronic
equipment.
RFemissions
CISPR11
ClassA
Harmonicemissions
IEC61000-3-2
ClassA
TheKeelerDesktopissuitableforuseinallestablishments
otherthandomesticandthosedirectlyconnectedtothe
publiclow-voltagepowersupplynetworkthatsupplies
buildingsusedfordomesticpurposes.
Voltagefluctuations/
flickeremissions
IEC61000-3-3
Complies
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Guidanceandmanufacturer’sdeclaration–electromagneticimmunity
Immunitytest
IEC60601Testlevel
Compliancelevel
Electrostatic
discharge(ESD).
IEC6100-4-2
±6kVcontact
±6kVcontact
±8kVair
±8kVair
Floorsshouldbewood,concreteorceramictile.
Iffloorsarecoveredwithsyntheticmaterial,the
relativehumidityshouldbeatleast30%.
Electricalfast
transient/burst.
IEC61000-4-4
±2kVforpowersupplylines
±1kVforinput/outputlines
±2kVforpowersupplylines
±1kVforinput/outputlines
Mainspowerqualityshouldbethatofatypical
commercialorhospitalenvironment.
Surge.
IEC61000-4-5
±1kVline(s)toline(s)
±1kVline(s)forlineto
earth
±1kVline(s)toline(s)
±1kVline(s)forlineto
earth
commercialorhospitalenvironment.
Voltagedips,short
interruptionsand
voltagevariationson
powersupplyinput
lines.
IEC61000-4-11
<5%UT(>95%dipinUT)
<5%UT(>95%dipinUT)
40%UT
(60%dipinUT)for5cycles
40%UT
70%UT
70%UT
commercialorhospitalenvironment.Ifthe
useroftheKeelerDesktoprequirescontinued
operationduringpowermainsinterruptions,itis
recommendedthattheinstrumentbepowered
fromanuninterruptiblepowersupply.
<5%UT
(>95%dipinUT)for5s
<5%UT
(>95%dipinUT)for5s
3A/m
3A/m
Powerfrequency
(50/60Hz)magnetic
field.IEC61000-4-8
Powerfrequencymagneticfieldsshouldbeat
alevelcharacteristicofatypicallocationina
typicalcommercialorhospitalenvironment.
NoteUTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.
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Guidanceandmanufacturer’sdeclaration–electromagneticimmunity
Immunitytest
IEC60601Testlevel
Compliancelevel
PortableandmobileRFcommunicationsequipmentshould
beusednoclosertoanypartoftheKeelerDesktop,including
cables,thantherecommendedseparationdistancescalculated
fromtheequationapplicabletothefrequencyofthetransmitter.
ConductedRF
IEC61000-4-6
3Vrms
3V
Recommendedseparationdistance
d=1.2√p
RadiatedRF
IEC61000-4-3
3V/m
3V/m
d=1.2√p80MHzto800MHz
80MHzto2.5GHz
d=2.3√p800MHzto2.5GHz
Wherepisthemaximumoutputpowerratingofthetransmitter
inwatts(W)accordingtothetransmittermanufactureranddis
therecommendedseparationdistanceinmetres(m).
FieldstrengthsfromfixedRFtransmitters,asdeterminedbyan
electromagneticsitesurvey¹,shouldbelessthanthecompliance
levelineachfrequencyrange.²
Interferencemayoccurinthevicinityof
equipmentmarkedwiththefollowingsymbol:
Note1 At80MHzand800MHz,thehigherfrequencyrangeapplies.
Note2 Theseguidelinesmaynotapplyinallsituations.Electromagneticpropagationisaffectedbyabsorptionandreflectionfromstructures,
objectsandpeople.
¹ Fieldstrengthsfromfixedtransmitters,suchasbasestations(cellular/cordless)telephonesandlandmobileradios,amateurradio,AMand
FMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywithaccuracy.ToassesstheelectromagneticenvironmentduetofixedRF transmitters,anelectromagneticsitesurveyshouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheKeelerDesktopis usedexceedstheapplicableRFcompliancelevelabove,theKeelerDesktopshouldbeobservedtoverifynormaloperation.Ifabnormal
performanceisobserved,additionalmeasuresmaybenecessary,suchasre-orientatingorrelocatingtheKeelerDesktop.
²Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.
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Recommended separation distances between portable and mobile RF communications equipment and the Keeler Desktop
The Keeler Desktop is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Keeler Desktop can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the Keeler Desktop as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
50 kHz to 80MHz
80MHz to 800MHz
800MHz to 2.5GHz
d = 1.2√ p
d = 1.2√ p
d = 2.3√ p
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.74
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
determined 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 80MHz and 800MHz, the separation distance for the higher frequency applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.
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30
17. Accessories and warranty
Accessories supplied
Thecustomeragreesthatitshallhavenoremedyintheevent
Dustcover
ofanybreachoftheforegoingwarrantyotherthanasprovided
PartNumberEP39-70435
Chinrestpaperpins(2) PartNumber2417-P-7006
above.Thiswarrantyisexclusiveandinlieuofallother
Pufftubedustcap
warranties,expressedorimplied,andallimpliedwarrantiesof
PartNumberEP39-70433
merchantabilityorfitnessforaparticularpurposeareexpressly
Consumables
disclaimed.
Chinrestpapers
PartNumber3104-L-8201
PrinterPaper
PartNumber2208-L-7008
Pulsair Warranty
ThePulsairDesktopanditscomponentsarecoveredbywarranty
thattheymeettheirperformancestandardsandarefreefrom
anydefectsinmaterialsorworkmanship.Within2yearsfrom
deliverybyKeeler,themanufacturershallatnochargetothe
customer,uponwrittennoticefromthecustomer,repairor
replaceanycomponentswhicharedefectiveinmaterialor
workmanship.
Theobligationsofthemanufacturerassetforthinthiswarranty
areexpresslyconditionedonthefollowing:(i)Noalterationsorrepairsofanymalfunctionofthesystem
shallbemadetothesystemexceptbythemanufacturerorhis
authorizedrepresentative,withoutthepriorwrittenapproval
ofthemanufacturerorhisauthorizedrepresentative(andinno
casewillthemanufacturerassumeresponsibilityforrepairsor
alterationsmadebythoseotherthanthemanufacturerorhis
authorizedrepresentative).
And(ii)Thecustomershallgivenoticetothemanufacturer
ortheirauthorizedrepresentativeofanymalfunctionofthe
systemandshallnotusethesystemforanydiagnosticpurpose
thereafter.
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31
18. Contact, packaging and disposal information
Manufacturer
Scotland Sales Office
USA Sales Office
Keeler Limited
Clewer Hill Road
Windsor
Berkshire
SL4 4AA
Keeler Scotland
25 Deerdykes View
Westfield Estate
Cumbernauld
G68 9HN
Keeler USA
456 Parkway
Broomall
PA 19008
USA
Freephone: 0800 521251
Tel: +44 (0) 1753 857177
Fax: +44 (0) 1753 827145
Freephone: 0800 521251
Tel: +44 (0) 1236 721214
Fax: + 44(0) 1236 721231
Toll Free: 1 800 523 5620
Tel: 1 610 353 4350
Fax: 1 610 353 7814
Disposal of old Electrical and Electronic Equipment
(ApplicableintheEuropeanUnionandotherEuropeanCountrieswith
ToReducetheEnvironmentalimpactofWEEE(WasteElectricalElectronic
separateCollectionSystems).
Equipment)andminimisethevolumeofWEEEenteringlandfillswe
encourageatProductendoflifethatthisEquipmentisrecycledandreused.
ThisSymbolontheProductoronitsPackagingandinstructions
indicatesthatitwasputonthemarketplaceafterAugust2005and
Ifyouneedmoreinformationonthecollectionreuseandrecyclingthen
thatthisproductshallnotbetreatedasHouseholdWaste.
pleasecontactB2BComplianceon01691676124(+441691676124).
0088
EP59-70019IssueA
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32

PDF Keeler Pulsair Desktop

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