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TABLE Of CONTENTs

CHAPTER 

01. General Information

Main Menu Structure ........................................................................................................................................6
Symbols and Abbreviation ..............................................................................................................................10
Brief Precautions and Limitations...................................................................................................................12

CHAPTER 

02. Introduction

Intended Use ...................................................................................................................................................13
Product Description .........................................................................................................................................13
Before You Start Testing ..................................................................................................................................13
System Components .......................................................................................................................................15

CHAPTER 

03. settings and Performance

Operating the Analyzer ...................................................................................................................................19
Performing a Measurement ...........................................................................................................................34

CHAPTER 

04. Using the Analyzer Memory and Data Transfer

Displaying Stored Measured Values................................................................................................................41
Send Results ....................................................................................................................................................42

CHAPTER 

05. Quality Control

Control Test ......................................................................................................................................................44
How to Perform Quality Control .....................................................................................................................45

CHAPTER 

06. Calibration 

Calibration Set Test ..........................................................................................................................................48
How to Use the Calibration Set Test ................................................................................................................49

CHAPTER 

07. Cleaning and Maintenance

Cleaning the Analyzer .....................................................................................................................................52
Maintenance and Transportation ...................................................................................................................52

Содержание Vcheck V200

Страница 1: ...V200 Fluorescent Immunoassay Systems User ManuaL For veterinary use only...

Страница 2: ...gyeong daero 1556beon gil Yeongtong gu Suwon si Gyeonggi do 16690 Republic of Korea Manufacturing site 74 Osongsaengmyeong 4 ro Osong eup Heungdeok gu Cheongju si Chungcheongbukdo 28161 Republic of Ko...

Страница 3: ...zer Familiarize yourself with the required preparations and the measure mentprocedurebeforeperformingthefirstmeasurement Pleasereadtheinsertincludedineachtestdevicepackage beforeyoutrytesting Ifyouhav...

Страница 4: ...onents 15 CHAPTER03 SettingsandPerformance OperatingtheAnalyzer 19 PerformingaMeasurement 34 CHAPTER04 UsingtheAnalyzerMemoryandDataTransfer DisplayingStoredMeasuredValues 41 SendResults 42 CHAPTER05...

Страница 5: ...PTER08 ScreenMessagesandTroubleshooting WarningMessages 53 ErrorMessages 55 ANNEX01 InformationforHealthcareProfessionals ProtectionagainstInfections 58 ANNEX02 Reference Warranty 59 Return 59 Disposa...

Страница 6: ...est Read Only Review Login Login Q C Result Search Select Calibration Results Detailed Results Send Results Patient Results Insert Device Insert Device Device Check Device Check Apply Sample Select Al...

Страница 7: ...visor Login Login Password Load Save Setting Update Info Manage Operator Insert Device Insert Device Insert Device Device Check Eject Device Eject Device Apply Sample Analyze Sample Check Finish Inser...

Страница 8: ...ator Send Unsent Result Settings Load Save S W Update ViewVersion Add Send All Q C Results SaveTest Records Delete Send All Patients Results Send All Results Operator ID Load Save F W Update View Netw...

Страница 9: ...9 Settings Set Print Option Set Calibration and Q C Instrument Name SetTimeout General Settings Date Time Language Units LIS Parameters Network Volume Brightness...

Страница 10: ...te Indicatesthattheproductisfragileandtohandleitwithcare Batchcode Indicatethelotnumberfortheanalyzer Indicatestodiscarditseparatelyfromotherhouseholdwaste This product fulfills the requirements of Eu...

Страница 11: ...viation Description cCRP CanineC ReactiveProtein fSAA FelineSerumAmyloidA Comm Communication LIS LaboratoryInformationSystem HIS HospitalInformationSystem GUI GraphicUserInterface S W Software F W Fir...

Страница 12: ...etheanalyzerinwaterorcleaningsolutions Toreducetheriskofincorrectresults Theanalyzershouldbeusedbytrainedoperators Donotuseiftheanalyzerisdisplayinganerrormessagethatcannotbecorrected Toobtainaccurate...

Страница 13: ...matic reaction occurs forming a dye and the amount of formed dye is proportional to the concentration of the analyte The intensity of visual color or fluorescence can be measured by illuminating with...

Страница 14: ...e range the acceptabletemperaturerangevariesdependingonthereagent Toperformameasurement placetheanalyzeronaflatsurface Strongelectromagneticfieldsmayimpairthefunctionoftheanalyzer Donotusetheanalyzerc...

Страница 15: ...Max50W OverVoltage Category Pollution Degree Memory 3000 RTC RTCBackupBatteryIncluded Size 214 9x261x203mm Labeling UserManual Barcode Scanner Optional BarcodeScanner Note The AC DC power adaptor is...

Страница 16: ...16 OverviewofBIONOTEV200analyzer A B C E G H I J K D F...

Страница 17: ...protectingtheprintersheet E PrinterCoverButton Useforopeningtheprintercover F DCJackPort Useforconnectingthepowersupplyadaptor12V 5Atoitscompartment G Powerswitch Useforturningon offtheanalyzer H USBx...

Страница 18: ...18 AccessoriesoftheBIONOTEV200analyzer Included Calibrationset CAL 1 CAL 2 CAL 3 Optional Testdevice Barcodescanner ForpatientIDrecognition 12V 5AAC DC poweradaptor Printpaper...

Страница 19: ...eanalyzerisreadyforuse STEP2 Setuptheanalyzer 2 1 Whensettinguptheanalyzerforthefirsttime theoperator sIDshouldberegistered Theinitial supervisorpasswordis0000 2 2 Itisrecommendedtoacknowledgethetable...

Страница 20: ...10 26 l 16 18 57 2 Inputthepasswordandpress OK forentry Theinitialpasswordis0000 Press Cancel ifyouwanttoreturntothe previoussetting 2016 10 26 l 16 19 00 3 Thesupervisormenutheallowstheoperatortoacc...

Страница 21: ...ID Pressthe Back button ifyouwanttoreturntotheprevioussetting 2 To add the operator s ID press Add Use the touch panel keyboard or a USB connected keyboard to add the operator sID 2016 10 26 l 16 19 1...

Страница 22: ...fanoperatorcurrentlyregisteredintheanalyzer press Edit BIONOTE 2016 10 26 l 16 19 24 BIONOTE 2016 10 26 l 16 19 30 5 Todeletethenameofanoperatorcurrentlyregisteredintheanalyzer press Delete BIONOTE 20...

Страница 23: ...beconnectedatanytimewiththeanalyzer spoweron 1 Toloadorsavethesettingsfortheanalyzer enterthe Load Save menuandpress Settings toproceed 2016 10 26 l 16 19 40 2 To load the appropriate analyzer data ac...

Страница 24: ...ssfully Press OK toconfirm 2016 10 26 l 16 19 50 4 Tosaveanalyzersettingsthatareclonedorduplicatesettingsfromanotherdevice press Save Whenthedatasave procedureiscompleted press OK toconfirm 2016 10 26...

Страница 25: ...toconfirm 2016 10 26 l 16 20 00 7 In addition the operator can save the operator s ID by pressing Save When operator s ID is saved press OK to confirm 2016 10 26 l 16 20 03 Note Theanalyzer stestresul...

Страница 26: ...ter connecting the USB device containingtheS WorF Wupdate 2016 10 26 l 16 20 08 2 Toupdatethenewanalyzersoftware press OK Theanalyzerwillreadthenewsoftwaretobeinstalled 2016 10 26 l 16 20 15 3 Toupdat...

Страница 27: ...ttingsorinstrumentname enterthe Settings menu Press Back toreturntothepreviousmenu 2016 10 26 l 16 20 25 2 To set the number of printed sheets as 1 2 or auto printing mode ON OFF enter the Set Print O...

Страница 28: ...inserting test device in to the analyzer and when the test is finished Standby mode means the user doesn t require any action even when insertingatestdeviceintotheanalyzer 4 Tosetthetimeperiodforcali...

Страница 29: ...undvolume orLCDbrightness enterthe GeneralSettings menu Especially underunitsettings testparameterscorrespondingtothetesttypecanbesetandthe parameterscanbeadjustedbyupdatingtheanalyzersoftware 2016 10...

Страница 30: ...ingthetestparameter sunit Canine CRP fSAA L Settingthenetwork 192 168 33 100 192 168 33 1 SettingtheLISparameter 192 168 33 200 5005 Note ConsultatechnicianforthenetworksettingsinformationortheLISpara...

Страница 31: ...31 Settingthesoundvolume LCDbrightness Settingtheinstrumentname V200...

Страница 32: ...32 6th Supervisor Info 1 Todisplayandviewtheanalyzer scurrentsoftwareversion firmwareornetwork enterthe Info menu 2016 10 26 l 16 22 30 2016 10 26 l 16 23 10...

Страница 33: ...onforthesoftwareandfirmwarewillbedisplayed Press OK toconfirm S W Version V1 00_R003 9 6 F W Version 0 4 Serial NO FA20A02AA0027 3 When ViewNetwork isselected informationaboutthenetworkwillbedisplayed...

Страница 34: ...analysisperiod TheReadOnlymodemaybethemostconvenientforlargevolumetesting astheanalyzercanquicklyreadmultiplepatientsamplessequentially StandardTestmode 1 First select the StandardTest mode Refer to t...

Страница 35: ...r s test slot The analyzerautomaticallyreadstheinformationforthetestdevice 4 When inserting the test device into the analyzer the analyzer will automatically check whether the device has beenusedornot...

Страница 36: ...pplyingthespecimen theanalyzerwill displayanerrormessageindicatingthatthetestcannotbeperformed Canine CRP 6 The analyzer automatically recognizes the test device The time required for analysis depends...

Страница 37: ...atient ID Date Operator ID Order Canine CRP 15 8 L 2016 11 25 17 36 47 guest Procedural Control Valid 9 When the OK button is pressed Eject Device will be displayed The test device can then be removed...

Страница 38: ...willregardtheoperatorasaguestuser 3 Preparetestdeviceandlabelthetestdeviceaccordingly Addpreparedspecimen 1totestdevice 1 thenimmediatelysetyourtimertothedesignatedprocessing timeasindicatedintheassay...

Страница 39: ...test device into the analyzer the analyzer will automatically check whether the test device has been used previously or not The analyzer also reads the barcode data and confirms the test device is val...

Страница 40: ...Operator ID Order Canine CRP 15 8 L 2016 11 25 17 36 47 guest Procedural Control Valid 6 Whenthe OK buttonispressed EjectDevice willbedisplayed Thetestdevicecanthenberemovedfromthe analyzer 7 When th...

Страница 41: ...n information and patient results can be reviewed separately in the review menu If you select an entry you can view the detailed results and send them to a PC or LIS HIS server through a LAN connectio...

Страница 42: ...42 SendResults 1 With several options available for sending the test results you can choose the most appropriate method to communicatewithdataserver Sendingtheunsentresults Sendingthelastresult...

Страница 43: ...43 Sendingallresults Sendingselectedresults...

Страница 44: ...roptheanalyzer Wheneveryourresultsarenotinaccordancewithyourexpectations Ifyouhaverepeatedatest andtheresultisstilllowerorhigherthanexpected Whenyouwanttochecktheperformanceoftheanalyzerandtestdevice...

Страница 45: ...olsolutionforeachtypeoftestdevice EntertheoperatorIDandCS Infobeforestarting Operator ID Control ID Control Order Note The operator ID and CS Info can be entered into the analyzer with the touch panel...

Страница 46: ...device is unusedornot Also theanalyzerwillreadthebarcodedata andconfirmthetestdeviceisvalidbeforestarting thetest 4 Whentheprocedurefor checkingthe test device iscompleted apply the control solutionto...

Страница 47: ...7 Once the analysis is finished the test results will be displayed The analyzer will print the test results if auto printingisenabled 8 Aftertheprocedureofanalyzingthetestdeviceiscompleted EjectDevice...

Страница 48: ...timalperformancebycheckingthedesignatedmethod Whentousecalibrationset Whenevertheanalyzerispoweredon Whenyoudroptheanalyzer Wheneveryoudonotagreewiththeresults Whenyouwanttochecktheperformanceofananal...

Страница 49: ...eforestartingthecalibration settest Note Theoperator sIDcanbeenteredintotheanalyzerwiththetouchpaneloraUSBkeyboard TheID canalsobeenteredwiththeBNbarcodereader whichissoldseparately 2 Once InsertDevic...

Страница 50: ...ther CAL 1 is unused or not Additionally the analyzer will read the barcode data and confirm the device is valid before starting the calibrationsettest Calibration 4 Theanalyzerwillautomaticallyscanan...

Страница 51: ...LEDtesting EnsurethatCAL 2andCAL 3areinsertedinorder Neverchangetheorder 7 Ifthemeasuredvalueiswithinthenormalrange OK willbedisplayedonthescreen 8 Ifthemeasuredvalueisnotwithinthenormalrange EEE will...

Страница 52: ...Caution Do not use an abrasive cloth or antiseptic solution as these may damage the display screen Alwaysswitchofftheanalyzerbeforecleaning MaintenanceandTransportation Each time the analyzer is turn...

Страница 53: ...cted Solution ConfirmUSBdeviceisconnectedcorrectly Warning Password Enteredincorrectsupervisorpassword Solution Entervalidpassword Warning UpdateFileNotFound TheupdatefiledoesnotexistontheUSBdevice So...

Страница 54: ...rID EnteredoperatorIDisnotregistered Solution AddoperatorIDinsetmode Warning OutofPaper Thereisnoprinterpaperintheanalyzer Solution Refillprinterpaper Warning IncorrectIPaddress CheckIPaddress Solutio...

Страница 55: ...iceandretestwithanewtestdeviceandanew specimen E02 BloodSpecimenError Aninsufficientamountofbloodhasbeenapplied Solution Retestwithanewtestdevicewithenoughblood ensuringthatthe sampleisplacedinthenarr...

Страница 56: ...er or printerhasfailed Solution Reconnect the analyzer and the external device If the error continuesafterturningtheanalyzerON OFF pleasecontactBioNote Inc E06 Totalhemoglobinoutofrange Themeasuredtot...

Страница 57: ...please contactBioNote Inc E13 UnsupportedTestDevice Loadedtestdeviceisnotappropriatefortheanalyzer Solution Check the type of test device and confirm it is manufactured by BioNote Inc EEE InternalErr...

Страница 58: ...urceofinfection Usegloves Applysampleoutsidetheanalyzer Followallotherlocallyapplicableguidelinesandregulationsonhealthandsafety ANNEX02 Reference 1 American Diabetes Association Clinical Practice Rec...

Страница 59: ...yoffitnessforanypurpose otherthanstatedherein This warrantydoesnotapplytotheperformanceofananalyzerthathasbeendamagedbyaccidentorhasbeenaltered misused tampered with or abused in any way This warranty...

Страница 60: ...V200...

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