SKANNEX AS X500 SkanFlexi User Manual

SKANNEX AS SkanFlexi

User Manual

SkanFlexi
LateralFlowMulti‐ReaderManual
ModelX500
Manufacturer:SkannexAS
Registeredmanufactureraddress:
Gaustadalléen21,NO‐0349Oslo,Norway
ContactNumber:(+47)99252274
Email:info@skannex.com
Web:www.skannex.com
Issued:2017
2
Notice
Allrightsreserved.Theinformationcontainedinthisdocumentissubjecttochange
withoutnotice.Reproductionorpublicationofthisdocumentinanyformatisprohibited
withoutthewrittenconsentofSkannexAS.
CopyrightInformation
SkanFlexiLateralFlowMulti‐ReaderManual
Documentversion1.0/November2017
©Copyright2017bySkannexAS
PrintedinNorway
SkannexAS
Gaustadallén21
N‐0349Oslo
Phone:+4799252274
email:info@skannex.com
web:www.skannex.com
3
Tableofcontent
1Generaldescription....................................................................................................................................4
2Readertechnicalparameters................................................................................................................5
2.1MainTechnicalParameters..........................................................................................................5
2.2Calibrationandperformancecharacteristics .......................................................................6
3Intendeduse.................................................................................................................................................6
4UnpackandInstallation ..........................................................................................................................7
4.1Unpack ...................................................................................................................................................7
4.2WorkingEnvironment ....................................................................................................................7
4.3InstallationofSkanFlexi.................................................................................................................8
5OperatingSkanFlexireader...................................................................................................................9
5.1Switchingreaderonandoff .........................................................................................................9
5.2Readingtestdevices .....................................................................................................................10
5.2.1PrintingfromSkanFlexiX500 ...............................................................................................12
5.4SkanFlexiisnotworking.............................................................................................................15
5.4.1Useofresetpin.............................................................................................................................15
6Maintenance..............................................................................................................................................16
6.1Dailycleaning...................................................................................................................................16
7Precautions................................................................................................................................................17
7.1Environmentlight..........................................................................................................................17
7.2Environmentingeneral...............................................................................................................17
8Transportationandstorage ...............................................................................................................17
8.1Transportation................................................................................................................................17
8.2.Storage................................................................................................................................................17
4
1Generalde s c r i p ti o n
SkanFlexiisareaderforanalyzingcolorimetricassaysbycapturingascannedimage.
Oneormultipletestscanbeanalyzedinonerun.Thescanningallowsthedetectionof
qualitativeand/orquantitativeresultdependingonthetestrunand/orsoftware
information.Thedataareautomaticallystoredandcanbeprintedand/orexportedto
externalsystem.
TheIVDequipmentcomplieswiththeemissionandimmunityrequirements
describedinthepartoftheIEC61326series,andtheelectricalandelectronically
safetyrequirementsdescribedinIEC61010.
SkanFlexihasthefollowingadvantages:
ReliableandCompactHardwareDesign
AdoptsRGBimagesfromPlustekOS550plusscannerforhighqualityresults.
Adoptspoweradaptorofprofessionalmanufacturerforsafetyand
adaptability.
Possibilitytoreadmanydifferentcassettes/stripsinonescan.
Possibilitytoreadmanydifferentcassettes/stripsinonescan.
Extractbatchspecificinformationfrombarcodeoneachcassette/strip.
Computequalitativeand/orquantitativeresults.
Friendlyuserinterface.Easytolearn,easytouse.
Storesmorethan75000results.
Software upgrade can be done by connecting the analyzer to Internet or
upgradefromanUSBmemorystick.
Thefollowingsignsareusedinthisdocument.
 Riskofelectricshock
Dangerous!Becareful.Referencetherequirementsofthismanual
IVD  Invitrodiagnosticdevices
5
2Readertechnicalparameters
Thisanalyzercanbeusedinmedicalinstitutionofanytypeandanylevel.
Thereaderisadedicatedinstrument,alloperationsmustbeaccordingtothe
manual.Ifnot,thereadermaybedamagedortestperformancecannotbe
guaranteed.
Riskofelectricshock.
2.1 MainTechnicalParameters
SpecificationTechnicalParameter
TestingPrinciples Colorimetricmeasurementsoflateralflowtestand
controllines
Operatingsystem Windows10
ExternalPorts
ThreeUSBports,forconnectiontoprinter,external
barcodereaderorUSBmemorystick
OneEthernetport,forconnectiontonetwork(Lanor
Wan).
OneRS232port,forconnectiontohospitalplatform
WiFi Wirelessconnection
PowerSupply 100‐250V(AC)
Frequencyrange 50‐60Hz
Currentrating 5Amp
Operatingconditions Forindooruseonly.Tobeplacedonasuitablebench.
Temperaturerange 15–30°C
RelativeHumidity 20‐80%RH
Storagecapacity Storesmorethan75000setsofresults(15GB)
Dimension 37.8x35.2x22.2cm(LxWxH)
Weight 4,5kg
6
2.2Calibrationandperformancecharacteristics
TheSkanFlexireader’stouchdisplayandthescannerpartarecalibratedandthe
opticalperformancequalitycheckedaspartoftheQCinthemanufacturingprocess.
ThescannerpartisfurtherrecalibratedbytheSWevery2ndweek.
Theperformancecharacteristicsofthereaderhavebeenevaluated.Inastudythe
intravariationandintervariationbetween4SkanFlexireadersshowedCVsbelow
5%.Thecomputedresultswerecalculatedaspropertyvalues;
(test–background)/(control–background).
Standardcurvesorthresholdsforthedifferenttestsareestablishedbythetest
manufacturer.Itisincludedaspartofthebarcodefollowingeachcassetteortemplate
andreadbythereader’sSW.
3Intendeduse
“TheintendeduseoftheSkanFlexireaderistoscan,readandcalculateresultsfrom
lateralflowtestswithinthemarketareasinvitrodiagnostics(IVD),e.g.laterflow
cassettesinMyocardialmarkers,CtnI,Myoglobin,CK‐MB,H‐FABP,etc.,orinfectious
disease,HbsAg,HbsAb,HCV,HP,etc.,orvenerealdisease,TP,Chlamydia,NGH,PSA,
CEA,etc.,drugsofabuse,veterinarydiagnostics,foodandfeedandenvironmentalin
bodyfluidsandotherextractedbiologicalliquids.”
Indicationsforuse:
Itisindicatedforbothquantitativeandqualitativetests.Todetectvariable
biomoleculeswithinhumanbodyfluids,andliquidextractsfromagricultural,animal
andenvironmentalsamples.
TheSkanFlexiproductisenabledbyaprogramkeyallowingcustomerstoupgradethe
proprietarysoftwaredirectlyfromWeboraUSBmemorystick.
Itisindicatedforrapidanalysisonsite.Theuserinterfaceshallbedesignedsuchthata
layusershallbeabletooperatethesysteminsuchawaythaterrorsofoperationand
resultinterpretationareminimizedtoanacceptablelevel.
7
4UnpackandInstallation
4.1Unpack
CarefullyremovetheSkanFlexireaderfromtheshippingbox.Inspectthereaderfor
visiblesignsofdamage.Ifdamagetothereaderexists,pleasefileacomplainttothe
logisticcompanyorretailersassoonaspossible.
Listofcontent:
ItemQuantity
SkanFlexireader 1
CertificateofQuality 1
WarrantyCard 1
SkanFleximanual 1
Powersupply 1
Resetpin 1
Packagelist 1
4.2WorkingEnvironment
Foroperator’ssafetyandtheproperoperationofthereader,thepowercordmustbe
pluggedintoanappropriatelygroundedACelectricaloutlet.Connectinganydualcord
powersurgeprotectorisstrictlyprohibited.
SkanFlexiisaprofessionalinstrument.Openingthecoverwithoutauthorizationis
prohibited.Theinstrumentandinstrumentpartsareonlytobeinspectedand
providedbythemanufacturer.
Operationviolatingthemanual’sdescriptionswillcausetheanalyzerdamaged.
Placethereaderonafirm,leveldesignedworkarea.
Pleaseavoidoperatinginthefollowingenvironment:
Indirectsunlight
Nearflammableandexplosivegas
Nexttoanopeningwindow
Nexttoheatingorrefrigerationequipment
8
Nearstronglightsource
4.3InstallationofSkanFlexi
AtthebackofthereadertherearethreeUSBports,oneEthernetport,oneRS232port,
oneon/offbuttonandpowersupplyconnection.
ConnectpowersupplytoSkanFlexi
Connectpowersupplytoelectricalsocket
9
5OperatingSkanFlexireader
5.1Switchingreaderonandoff
Switchonreaderbysettingon/offbutton(attherearofthereader)toposition
“On”
Computerwillbeswitchedonandpowerindicatedled(atfrontleftcornerofthe
reader)becomesgreenandisflashinguntilreaderprogramstarts.
SkanFlexiisreadyforuse
Whenswitchingoffthereaderpress“Exit”buttoninthereaderprogram
Poweroffreaderbysettingtheon/offbuttontoposition”Off”.Thepower
indicationledwillswitchoff.
Warning:AfterSkanFlexiisswitchedoffbyeitherpressingexitbuttoninSkanFlexi
softwareorswitchingtheon/offbuttontooff,thenwaitatleast10secondsbefore
switchingtheon/offbuttonon.
IftheSkanFlexiisnotstartingpleasefollowprocedureinCh.5.4
10

5.2Readingtestdevices
1. Pushandopenthedrawer
2. Placethetestdevicerightsideuponthescannersurface
3. Ensurethattestandcontrollinesareplacedinthescanner’smovementdirection.
4. Incubationcanbeperformedbeforeorafterplacingthetestdeviceintothe
drawer.
5. Multipletestdevicescanbeplacedinthedrawerandbereadatthesametime.
6. Closedrawerbeforescanningtoavoidinterferencefromsurroundinglights.
7. Press“ReadTest”buttoninprogram.Scanningofthecassettewillstartandresult
willappearafterafewseconds.
11
8. Enterrequiredinformationinresultscreen.
9. Resultsareautomaticallystoredinhistoriclog.
10. Apdfreportmaybeprintedfromthisscreenif“PrintReport”buttonisselected
andprinterisinstalledandconnected.
11. Pdfreportcanalsoanytimebeprintedfromthehistoriclogscreen.Thelogis
openedwhen“ViewLog”buttoninmainscreenisselected.
12. Whenresultscreenisfilledinwithrequireddata,closethisscreenbyselecting
“Close”button.Youwillreturntomainscreenandprogramisreadyforreading
newtestdevices.
12
5.2.1PrintingfromSkanFlexiX500
SkanFlexiX500isusingaWindowstablet.AnyWindowsoperatingprintercanbeused.
5.3 Cleaningthereaderscanner
Thescannercanbecleanedbyfollowingthestepsbelow.
Closetheinstrumentanddisconnectthepowersupplycord.Openthedrawer
andtakeoutthetemplate.
Closethedrawerandturnovertheinstrument.
13
Pushthe“Open”sideandremovethebottomplate.
Openthedrawerandrotatetheblackholdertolockit.

14
Cleanthescannerwithhumidclothorwithalcohol.

Rotatetheblackholder,closethedrawerandputbackthebottomplate.
15
Pushthe“Close”sideandfixthebottomplate.Turnovertheinstrumentandput
backthetemplateintothedrawer.
5.4SkanFlexiisnotworking
SkanFlexi’stouchpanelhasabatteryinside.InthecaseSkanFlexihasnotbeenusedfor
days,thetouchpanelwillhavenopower.Therefore,pleasechargetheSkanFlexiforat
least10minutesifSkanFlexihasnotbeenworkingfordays.
1)ConnectpowersupplytoSkanFlexi
2)Switchonreaderbysettingon/offbutton(attherearofthereader)toposition
“On”
3)AfterchargingtheSkanFlexiforatleast10minutes,switchoffthereaderby
settingon/offbutton(atrearofthereader)toposition“Off”
4)Switchonreaderagain,andSkanFlexiwillstart
5.4.1Useofresetpin
IfSkanFlexiisstillnotworkingafterperformingtheabovestepsin5.4,pleasefollow
belowresetprocedure:
1) Switchonreaderbysettingon/offbutton(attherearofthereader)toposition
“On”
2) UsetheprovidedResetpintopushtheresetbuttonfor15‐20seconds
3) Switchoffthereaderbysettingon/offbutton(attherearofthereader)to
position“Off”
4) Switchonthereaderagainbysettingon/offbutton(attherearofthereader)to
position“On”
5) SkanFlexiwillstart
16
IftheSkanFlexiisstillnotworking,pleasecontactSkannexASat:
support@skannex.com
AswithanyotherinstrumentsthetabletinSkanFleximightappearwiththefollowing:
1. Systemcrash/tabletseemtobe“frozen”
2. BlurredscreenwhenyoustartupSkanFlexiorwhenSkanFlexiisrunning
3. RecoverynotificationwhenyoustartupSkanFlexi
Inallthesecasesthe“Resetpin”shouldbeused.Pleasefollowdescriptionabove.
6Maintenance
6.1Dailycleaning
Keepreadercleanbyusingadampcloth
Scannersurfacemaybecleaned/decontaminatedwithalcoholifnecessary
Touchscreenshallbecleanedwithspecialtissuesintendedforresistivescreen
Donotuseaggressivesolventssuchasacetone.
17
7Precautions
7.1Environmentlight
KeepSkanFlexioutofdirectsunlightorotherstronglightsourcesasthiscancause
interferencewhenscanning,whichagaincanresultinwrongornoresults.
7.2Environmentingeneral
Protectthereaderfromhighhumidityandextensivecontacttoliquids.
Donotexposethereadertoextensiveheat.
Insomecasesapoorgroundconnectioninsocketandinterferenceofsomelarge
medicalequipment(X‐raymachine,CTmachine),cancausethattheSkanFlexiget
ElectroMagneticInterference(EMI)problem.Thiscanbeseenasaseriesofsmall
circles/rectanglesappearingwhentouchingthepanel.Thiscanmakeitdifficultto
touchthecorrectposition.Changingtosocketwithbettergroundingormoving
SkanFlexiawayfrominterferenceenvironmentwillresolvethiskindofproblem.
.
8Transportationandstorage
8.1 Transportation
SkanFleximustbetransportedinthesamepackingmaterialasitwasreceivedin.
Transportationshouldbedoneusingacommonshippingcompanyundernormal
conditions.
8.2.Storage
SkanFlexishouldbestoredinanup‐rightpositionintheoriginalpackingmaterial,
indoorandundernormalroomtemperatureandenvironmentconditions.Avoid
directsunlight.Formoredetailsseetable2.1.
18
FCC STATEMENT
1. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause
undesired operation.
2. Changes or modifications not expressly approved by the party responsible for compliance could
void the user’s authority to operate the equipment.
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates, uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
—Consult the dealer or an experienced radio/ TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposurere quirement.
The device can be used in portable exposure condition without RF striction

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