MURAIRO WEKUSHANDISA
PLORER Macro Array Diagnostics
DISCLAIMER
MacroArray Diagnostics yakasimbisa mirairo yakapihwa, reagents, chiridzwa, software, uye zvinogoneka zvinogoneka kune ino analyzer kuti ikwidzise kuita kwechigadzirwa uye kusangana nezvido zvechigadzirwa. Magadzirirwo anotsanangurwa nemushandisi haatsigirwe neMacroArray Diagnostics nekuti anogona kukanganisa kuita kweanalyzer uye mhinduro dzebvunzo. Ibasa remushandisi kusimbisa chero shanduko dzakaitwa kune aya mirairo, zviridzwa, reagents, kana software inopihwa neMacroArray Diagnostics.
Ndokumbira utarise mirairo yakakodzera yekushandisa ALEX² uye FOX bvunzo usati wagadziriswa!
ZVINOTAURWA NEZVINHU
Gwaro iri rakatariswa kuti rakarurama here. Mirayiridzo uye tsananguro yeImageXplorer yaive yechokwadi panguva yakanyorwa gwara iri. Mazano anotevera anogona kuva
kuchinjwa pasina chiziviso chekare; zvisinei, MacroArray Diagnostics haitore mhosva yekukuvadza kunokonzerwa zvakananga kana zvisina kunanga nekukanganisa kubva kugwaro. Iyo ImageXplorer ndeye in-vitro diagnostic madivayiri ayo anoitirwa kuti ashandiswe nevashandi vakadzidziswa marabhoritari chete.
Gwaro iri uye software yakatsanangurwa inodzivirirwa nekodzero. Hapana chikamu chegwaro iri kana chesoftware yakatsanangurwa inogona kudhindwa, kudhindwa, kana kukopwa kune yemagetsi svikiro kana inoverengwa nemuchina pasina mvumo yakanyorwa yakanyorwa kubva kuMacroArray Diagnostics.
TERMS AND DEFINATIONS
| Kukuvadza | Kukuvara kwemuviri kana kukuvadzwa kuhutano hwevanhu, kukuvadzwa kwezvinhu kana nharaunda. |
| Chinangwa Operation | Kushanda, kusanganisira kugadzirira kushanda, maererano nemirairo yekushanda kana kushandiswa kwakagadzirirwa. |
| Chinangwa Kushandiswa | Kushandiswa kwechigadzirwa, nzira, kana sevhisi zvinoenderana nezvinodiwa uye mirairo inotsanangurwa neMacro Array Diagnostics (MADx). |
| Kukuvadza kuri pachena | Kukuvadza kunogona kuonekwa neziso rakashama chete nekunyatsocherechedza kweanalyzer kana chikamu chayo, kana nekutarisa zviratidzo zviripo, zviratidzo, kana data yakatumirwa. |
| Operator | Munhu kana boka rine mutoro wekushandiswa nekugadzirisa mudziyo. Mushandi anoita shuwa kuti vashandisi vakarairwa zvakakodzera nezve mashandisiro anoita mudziyo. |
| Process | Zvishandiso uye zviitwa zvinodyidzana kushandura zvinopinda kuita mhedzisiro. |
| Vashandi vakadzidziswa | Vashandi vakapedza chirongwa chedzidzo chakazivikanwa chebasa ravakapihwa, vanoziva zvinhu zvakakosha uye njodzi dzenzvimbo yavo yebasa uye vanoenderera mberi nedzidzo yavo nezvidzidzo zvenguva dzose nezve shanduko nebudiriro (senge miitiro uye nhungamiro. ) zvinoenderana nedzidzo yavo nebasa ravo. |
| Mushandisi | Munhu anoshandisa mudziyo maererano nezvakatemwa. |
| Validation | Simbiso nekupa humbowo hwekuti izvo zvinodikanwa zvekushandiswa kwakanangana nekushandiswa kana kurongedzerwa chaiko kwakazadzikiswa. |
| Verification | Simbiso nekupa humbowo hwechinangwa chekuti zvinodiwa zvinotsanangurwa zvakazadzikiswa. |
ZVIRI KUDA KUSHANDISA KUIMAGEXPLORER
Iyo ImageXplorer chiridzwa uye chakagadzirirwa sekuwedzera kune ALEX tekinoroji-yakavakirwa zvigadzirwa.
Chigadzirwa chekurapa cheIVD chinotora mifananidzo yeALEX tekinoroji-yakavakirwa arrays uye inoshandiswa nevashandi vakadzidziswa marabhoritari uye nyanzvi dzekurapa murabhoritari yekurapa.
MUNHU UYE KUITA LABEL
V.1 MUNHU
Iyo ImageXplorer inogadzirwa neMacroArray Diagnostics (MADx)
MacroArray Diagnostics
Lemböckgasse 59/Top 4
A-1230 Vienna, Austria
V.2 KUZIVISA ZVINHU
Chiziviso chezita chinoiswa kumashure kweiyo ImageXplorer.
VI. PERFORMANCE DATA
VI.1 ASAY CALIBRATION
Kune iyo Assay Calibration tarisa kune inoteedzana IFU yeALEX² kana FOX bvunzo.
VI.2 KUYERA RANGE
Kune Yekuyeresa Range tarisa kune yakatarisana IFU yeALEX² kana FOX bvunzo.
VI.3 KUTUNGAMIRIRA ZVINHU
Kuchengeta rekodhi kune yega yega bvunzo:
Zvinoenderana nemaitiro akanaka emurabhoritari zvinokurudzirwa kurekodha nhamba dzemajenya ese anoshandiswa. Nhamba dzakawanda dzeese reagents dzinochengeterwa kune yega kumhanya uye ruzivo runogona kudzoserwa kumashure kune yega Run ID kuburikidza neRAPTOR SERVER Analysis Software.
Kudzora Sayenzi:
Maererano nemaitiro akanaka erabhoritari zvinokurudzirwa kuti kutonga kwehutano sampLes inosanganisirwa mukati menguva dzakatsanangurwa. MacroArray Diagnostics inopa kugamuchirwa kwezvikwata zvemazuva ano eLyphochek® sIgE Control Panel A. Aya maitiro akachengetwa muRAPTOR SERVER uye haagoni kugadziriswa nemushandisi.
VI.4 DATA ANALYSIS
ALEX² uye mifananidzo yeFOX inoongororwa otomatiki pachishandiswa MADx's RAPTOR SERVER uye mushumo unogadzirwa uchipfupisa mibairo yemushandisi.
VI.5 RESULTS
ALEX² inzira yehuwandu yeiyo chaiyo IgE uye yehafu-yehuwandu nzira yehuwandu hweIgE yekutsunga. Allergen- specific IgE masoja ekudzivirira chirwere anotaridzwa seIgE mhinduro maunitsi (kUA/L), ese eIgE mhedzisiro se kU/L. MADx's RAPTOR SERVER Analysis Software inoverengera otomatiki uye inoshuma sIgE zvawanikwa (muhuwandu) uye tIgE zvawanikwa (semi- uwandu).
FOX ndiyo semi-quantitative nzira yeiyo IgG kutsunga. Yakananga IgG masoja ekudzivirira chirwere anoratidzirwa seIgG mhinduro zvikamu (µg/ml). MADx's RAPTOR SERVER Analysis Software inoverengera uye inoshuma sIgG mhinduro semi-huwandu semakirasi (akaderera, epakati, uye akakwira zvakanyanya).
VI.6 KUDZIDZWA KWEMAITIRO
Kune Kuganhurirwa kwemaitiro tarisa kune yakatarisana IFU yeALEX² bvunzo kana FOX bvunzo.
VI.7 ZVINOTARISIRWA ZVINOKOSHA
Pamakoshero anotarisirwa tarisa kune yakatarisana IFU yeALEX² bvunzo kana FOX bvunzo.
VI.8 ZVINHU ZVOKUITA
ALEX² bvunzo:
Precision:
Kune iyo chaiyo, isu tinonongedzera kune chikamu chekuita maitiro muIFU yeALEX² bvunzo.
Kudzokororwa (mukati-kumhanya chaiko):
Muchidzidzo chekudzokorora, yakawanda-sensitized sampLes dzakaedzwa ka10 nemushandisi mumwechete pamazuva akasiyana. Chidzidzo ichi chaisanganisira 319 allergens pa sample misanganiswa
kuvharisa 165 ega ega zvinobatika pamatanho matatu akasiyana (>3 kUA/L, 10-1 kUA/L uye 10-0.3 kUA/L).
| Kukochekera – kUA/L | Yese CV% |
| ≥ 0.3 - <1.0 | 25.6 |
| ≥ 1 - <10 | 13.8 |
| ≥ 10 | 10.7 |
| ≥ 1 | 13.5 |
Analytical Sensitivity:
Kune Muganho Wekuonekwa, isu tinonongedzera kune chikamu chekuita maitiro muIFU yeALEX² bvunzo.
Analytical Specificity:
Kune iyo Analytical Specificity, isu tinonongedzera kune chikamu chekuita maitiro muIFU yeALEX² bvunzo.
Kupindira:
Nekuvhiringidza nezvimwe zvinhu, isu tinoreva chikamu chekuita maitiro muIFU yeALEX² bvunzo.
FOX bvunzo
Kururamisa (kusiyana kwakawanda):
Iyo mijenya-ku-mijenya mijenya yakatemerwa pa3 cartridge mijenya mumatanho matatu akasiyana. Multisensitized sampLes dzakabatanidzwa muchidzidzo. Chidzidzo ichi chaisanganisira 867 allergen/sampmasanganiswa anofukidza zana nemakumi maviri nerimwe ega ega alleji pamusoro peyerero yese yekuyeresa.
| Kuwedzera - µg/ml | Intra CV% | Inter CV % | Yese CV% |
| 10.0-19.9 | 6.9 | 11.2 | 9.1 |
| ≥ 20 | 3.1 | 5.5 | 4.3 |
| ≥ 10 | 4.8 | 7.9 | 6.3 |
Kudzokororwa (mukati-kumhanya chaiko):
Muchidzidzo chekudzokorora, yakawanda-sensitized sampLes vakaedzwa ka10 nekuvhiya kwakafanana pamazuva akasiyana. Chidzidzo ichi chaisanganisira 862 antigen/sampmasanganiswa anovhara 115 ega maantigen pamusoro peyese renji yekuyera.
| Kuwedzera - µg/ml | Yese CV% |
| 10.0-19.9 | 11.3 |
| ≥ 20 | 5.4 |
| ≥ 10 | 7.2 |
Analytical Sensitivity:
Kune Muganho Wekuonekwa, isu tinotaura kune chikamu chekuita maitiro muIFU yeFOX bvunzo.
Kupindira:
Nekuvhiringidza nezvimwe zvinhu, isu tinoreva chikamu chekuita maitiro muIFU yeFOX bvunzo.
VII. ZVINOTAURWA ZVINOITA
VII.1 ALEX² TEST PRINCIPLE
ALEX² is solid-phase immunoassay. Allergen extracts kana molecular allergens, ayo akabatanidzwa kune nanoparticles, anoiswa mune yakarongeka fashoni pachikamu chakasimba, ichigadzira macroscopic array. Chekutanga, iyo particle yakasungwa allergens inobata neIgE chaiyo iripo mumurwereample. Mushure mekuvharirwa, isina-chaiyo IgE inogezwa. Maitiro acho anoenderera mberi nekuwedzera enzyme yakanyorwa anti-human IgE yekuona antibody iyo inoumba yakaoma ine particle yakasungwa chaiyo IgE. Mushure mechikamu chechipiri chekugeza, substrate inowedzerwa iyo inoshandurwa kuita isinganyungudika, ine mavara emvura neiyo antibody-yakasungwa enzyme. Pakupedzisira, iyo enzyme-substrate reaction inomiswa nekuwedzera inovharira reagent. Huwandu hwekunaya kwemvura hunoenderana nehuwandu hweIgE chaiyo mumurwere sample. Iyo assay maitiro inoteverwa neotomatiki yekutora mufananidzo uye ongororo iyo yakabatanidzwa muImageXplorer. Mhedzisiro yebvunzo inoongororwa neMADx's RAPTOR SERVER Analysis Software uye yakashumwa muIgE mhinduro zvikamu (kUA/L). Yese mibairo yeIgE inoshumwawo muIgE mhinduro zvikamu (kU/L).
VII.2 FOX TEST PRINCIPLE
FOX is solid-phase immunoassay. Zvokudya zvakatorwa, izvo zvakabatanidzwa kune nanoparticles, zvinoiswa mune yakarongeka fashoni pachikamu chakasimba ichigadzira macroscopic array. Chekutanga, iyo particle yakasungwa mapuroteni anoita neIgG chaiyo iripo mune yemurwereample. Mushure mekuvharirwa, isina-chaiyo IgG inogezwa. Maitiro acho anoenderera mberi nekuwedzera enzyme yakanyorwa kuti anti-human IgG yekuona antibody iyo inoumba yakaoma ine chidimbu chakasungwa chakananga IgG. Mushure mechikamu chechipiri chekugeza, substrate inowedzerwa iyo inoshandurwa kuita isinganyunguriki, ine ruvara rwemvura neiyo antibody-yakasungwa enzyme. Pakupedzisira, iyo enzyme-substrate reaction inomiswa nekuwedzera inovharira reagent. Huwandu hwekunaya kwemvura hunoenderana nekusangana kweIgG chaiyo mumurwere sample. Iyo lab yekuyedza maitiro inoteverwa neotomatiki yekutora mufananidzo uye ongororo iyo inosanganiswa muImageXplorer. Mhedzisiro yebvunzo inoongororwa neMADx's RAPTOR SERVER Analysis Software uye yakashumwa muµg/ml uye mumakirasi eIgG.
VIII. SERVICE
MacroArray Diagnostics kana vaparadzi venzvimbo varipo kuti vagadzirise mudziyo panguva dzenguva dzehofisi dzenzvimbo. Kana sevhisi ichidikanwa chero imwe nguva, bata MacroArray Diagnostics service (support@macroarraydx.com) kana muparidzi wenzvimbo yako. Ukuru hwesevhisi yakabvumiranwa inosanganisirwa mukondirakiti yako yebasa.
IX. Garandi
MacroArray Diagnostics uye vagovera vayo vemunharaunda vanovimbisa kuti ImageXplorer haizoratidze chakakanganisika panguva yekushanda kana ikaiswa uye ikashandiswa zvinoenderana neiri bhuku nevashandi vanokwanisa uye vakadzidziswa. Kuti uwane rumwe ruzivo nezve waranti, bata MacroArray Diagnostics sevhisi kana vaparadzi vayo. Warrandi haina kushanda pakukuvadzwa kunoitika nekuda kwekusatevedzera bhuku iri, uko kugadzirisa uye kusevhisi kunofanirwa kuitwa chete nevanhu vakadzidziswa uye vakasimbiswa neMacroArray Diagnostics. Kuchengeta kunoda kuitwa sekutsanangurwa kwazvinoitwa mubhuku rino. Kupindira kusina kunaka pamudziyo kunobvisa waranti uye kunogona kukonzera kubhadharwa kwebasa. Shandisa mudziyo chete sezvaunoda. Kana chishandiso chikasashandiswa sezvakarongerwa, MacroArray Diagnostics inorambira mhosva yese yekukuvadza kune muongorori.
KUOdha RUZIVO
Shandisa zvinodyiwa chete, zvishongedzo uye zvikamu zvakasara zvinopihwa kana kukurudzirwa neMacroArray Diagnostics. Odha zvinhu izvi chete kubva kuMacroArray Diagnostics kana yemuno
distributors. Kuti uwane ruzivo rwekuodha, ona bhurocha reMacroArray Diagnostics kune yedu ImageXplorer bata MacroArray Diagnostics timu pa. orders@macroarraydx.com kana muparidzi wenzvimbo yako.
Iyo MADx chinyorwa nhamba (REF) yeImageXplorer ndeye 11-0000-01.
XI. KUBATA KWAKAKAKONZERA
Iyo analyzer yakaongororwa kuchengetedzwa kwehunyanzvi isati yatumirwa. Kuchengetedza chimiro ichi uye kuve nechokwadi chekushanda pasina njodzi:
- Gara uchitevera mirairo iri mubhuku rino.
- Nguva dzose tevera maitiro akanaka e laboratori.
Uye zvakare, MacroArray Diagnostics inotaura zvakajeka kuti kushandisa analyzer nenzira isina kutaurwa neiri bhuku kana kumwe kunhu neMacroArray Diagnostics kunogona kukanganisa matanho ekuchengetedza anoitwa nemugadziri uye zvinogona zvakare kukonzera ine njodzi mamiriro kana kutungamira kune isiriyo bvunzo mhinduro.
XI.1 KUFUNGWA KWEOPERATOR
Iyo ImageXplorer inofanirwa kushandirwa kana pasi pekutariswa kwenyanzvi kana opareta anonyatsokodzera basa rerabhoritari. Usati washandisa ImageXplorer uye RAPTOR SERVER Analysis software, mushandisi anofanira:
- Verenga iyi Mirairo Yekushandisa zvakanyatsonaka
- Iva nehanya nezvese zvinoenderana nema laboratory maitiro
- Iva neruzivo nezvese akakodzera mitemo yekuchengetedza uye mirau
Nyatsotevedzera maitirwo akataurwa muMirairo iyi Yekushandisa pakushanda nekuchengetedza sisitimu. Kuchengetedza kusina kutsanangurwa muMirayiridzo Yekushandisa kunofanira kusiiwa kune mainjiniya ebasa vanokwanisa.
Usavhura imba yemidziyo!
Midziyo yemagetsi inogona kuve sosi yekuvhundutsa kwemagetsi!
Sevhisi uye Kugadzirisa kunofanirwa kungoitwa neMacro Array Diagnostics kana vagovera venzvimbo.
XI.2 KUCHENGETEKA KWEKUSHANDA
Sezvinoita chero mechanika system, mamwe matanho ekuzvidzivirira anofanirwa kutorwa paunenge uchishandisa mufananidzo.
USAITA kutakura hunyoro kana makaturiji akanyorova!
Chero mvura yadeuka pachiridzwa inogona kukonzera kusashanda kwehurongwa. Kana mvura yadeuka pachiridzwa, pukuta ipapo nekukasira uye ubate technical support.
XI.3 DECONTAMINATION
Nekuda kwezvikonzero zvekuchengetedza, iyo ImageXplorer inofanirwa kuvharirwa / kusvibiswa isati yagadziriswa uye basa rebasa raitwa. Ita shuwa kuti unotevera mirairo yekusvibisa analyser. Usati wasvibiswa uye/kana disinfection, bvisa analyzer kubva kune magetsi (dhonza plug). Mushandisi ndiye ega ane basa rekubudirira kwenzira dzekuuraya hutachiona uye decontamination dzinoshandiswa uye kusimbiswa kwavo.
XII. RUGWARO RWEZVIRATIDZO
 |
Bvunza mirairo yekushandisa |
 |
In vitro diagnostic medical device |
 |
CE chiratidzo |
|
Mugadziri |
 |
Siriyero nhamba |
 |
Kurasa midziyo yemagetsi neyemagetsi |
|
Kuchenjerera |
XIII. MASHOKO EKUCHENGETEKA
Ese mameseji ekuchengetedza anofanirwa kucherechedzwa kudzivirira mamiriro ane njodzi anogona kuguma nerufu, kukuvara, kana kukuvadzwa kwemidziyo.
Inoratidza mamiriro ane ngozi ayo, kana akasadziviswa, anozoguma nerufu, zvakakomba kana kukuvara kudiki.
XIV. ZVINODIWA NEPAMBERI
XIV.1 INTERNATIONAL STANDARDS
Iyo ImageXplorer yakagadziridzwa, yakaedzwa, uye yakagadzirwa zvinoenderana ne
EN ISO 13485, EN IEC 61010-2-101, EN ISO 14971, EN IEC 61326-2-6, EN ISO 62304 uye EN ISO 62366.
XIV.2 CE CONFORMITY
Iyo ImageXplorer inobata mucherechedzo weEC unosimbisa kuti michina inosangana nezvinodiwa zveinotevera mirairo yeEurope:
- In Vitro Diagnostic Medical Devices Directive 98/79/EC
- Directive paWaste Electrical and Electronic Equipment 2012/19/EU
- Directive pamusoro peKurambidzwa kwezvinhu zvine njodzi 2011/65/EC
XIV.3 ELECTROMAGNETIC COMPATIBILITY (EMC), RADIO INTERFERENCE kudzvinyirirwa UYE KUDZIVIRIRA KUKANGANISA
Iyo ImageXplorer yakaedzwa zvinoenderana neEN IEC 61326-2-6 uye inoenderana neCISPR 11 Kirasi B.
XV. HUPENYU HONDO
Ichi chikamu chinotsanangura stages iyo ImageXplorer inopfuura, kutanga kubva pakutumira kusvika pakuraswa, uye izvo zvinodiwa kune anoshanda mukati mesetage.
XV.1 KUSVIRA
XV.1.1 KUKATADZWA PANGUVA YOKUTANGA
Iko kurongedza kwekunze kweImageXplorer inova nechokwadi chekudzivirira kwakanyanya kubva pakukuvara kwekufambisa. Zvakadaro, ndapota tarisa kutumirwa kwega kwega nekukasira pawatambira kuti uone kukanganisa kwekutakura. Kana iwe ukagamuchira kutumirwa kusina kukwana kana kukuvadzwa, ndapota taura zvakananga neMacroArray Diagnostics kana muparidzi wenzvimbo yako. Ndapota zivisa mutakuri nezvekukuvara kuri pachena.
XV.1.2 CHIKORO CHEKUSVIRA
| Included Items |
| 1x ImageXplorer |
| 1x ImageXplorer Carriage |
| 1x yekubatanidza tambo (PC kune ImageXplorer) |
Tafura 1 Rondedzero yezvinhu zviripo pakuendesa
Pakushanda kwechishandiso, ALEX² (50x: REF 02-5001-01 kana 20x: REF 02-2001-01) kana FOX (REF 80-5001-01) kit yekuongorora inodiwa, iyo isingabatanidzwe mukutakura. ye ImageXplorer uye inofanirwa kuodha zvakasiyana.
XV.2 KURASA
MuEuropean Union, kuraswa kweanalyzer kunodzorwa neDirective 2012/19/EU pamarara emagetsi nemagetsi zvishandiso (WEEE) uye zvinoenderana nenyika.
MacroArray Diagnostics yakazvipira kudzosera nekudzokorodza midziyo yemagetsi neyemagetsi munzvimbo dzinotevedzwa chirevo chataurwa pamusoro.
Munzvimbo dzisina murairo wataurwa pamusoro usiri kutevedzerwa, bata MacroArray Diagnostics sevhisi kana muparidzi wenzvimbo maererano nekuraswa kweanoongorora.
Zvichienderana nemashandisirwo, zvikamu zve analyzer zvinogona kunge zvakasvibiswa ne biohazardous kana ine ngozi kemikari zvinhu.
Bata zvinhu zvine utachiona maererano nemitemo yenyika uye yemunharaunda. Usati watakurwa kana kuraswa, disinfective zvikamu zve analyzer izvo zvinogona kunge zvakasvibiswa zvinoenderana nenyika uye yemunharaunda zviyero nemirairo. Kana iwe uchida rubatsiro, bata MacroArray Diagnostics kana muparidzi wenzvimbo.
Usabate midziyo yemagetsi neyemagetsi semarara emanisipala asina kucheneswa uye bvunza mukontrakta wenzvimbo yako wekurasa marara kuti uwane zvinodiwa maererano nekurasa. Ndokumbira uunganidze tsvina yemagetsi neyemagetsi zvakaparadzana uye udzorere kuMacroArray Diagnostics kana muparadzi wenzvimbo munzvimbo dzinotevedzwa chirevo chataurwa pamusoro.
XV.3 DATA NEgadziriro yeparutivi
Paunenge uchishandisa RAPTOR SERVER Analysis Software, data rese rekuongorora uye nemurwere rinochengetwa zvinoenderana neMADx Terms of Service Agreement muMicrosoft Azure Online Portal. Ndokumbirawo utarise kune Online Services Terms (OST) yeMicrosoft, inowanikwa pa https://www.microsoft.com/en-us/licensing/product-licensing/products. Kune iyo RAPTOR SERVER pane-nzvimbo vhezheni, ndokumbirawo ubvunze nekwako IT administrator.
XVI. DESCRIPTION
A: chasi
B: mutserendende
C: ngoro
Iwo akakodzera sisitimu zvikamu zve ImageXplorer ndezvi:
- CCD (charge-coupled device) Kamera yekutora mufananidzo
- Custom LED chiedza chedunhu bhodhi
- Ngoro yekuisa ma cartridges
- Stage yekutsvedza chibatiso che cartridge
- USB 2.0 kana USB 3.0 tambo
XVI.1 KUbatanidza IMAGEXPLORER kuPC
Iyo ImageXplorer haisi yega yega uye inofanirwa kugara ichishandiswa pamwe chete neRAPTOR SERVER Analysis Software. Iyo ImageXplorer inobatanidzwa mukombuta kuburikidza neiyo yakapihwa USB 2.0 kana USB 3.0 tambo, uye zvese zvinongedzo uye magetsi anofambiswa kuburikidza nekombuta USB 3.0 chiteshi netambo yakapihwa USB.
Cherechedza: Chishandiso ichi chinogona zvakare kushandiswa pachiteshi che USB 2.0, asi kuongororwa kunoda nguva yakareba nekuda kwemazinga akaderera ekufambisa data.
XVI.2 RAPTOR SEVA SOFTWARE KUGADZIRA
Google Chrome inokurudzirwa sebrowser yekushandisa iyo RAPTOR SERVER. Iyo graphical mushandisi interface yeRAPTOR SERVER inogona kuwanikwa pa websaiti:
https://www.raptor-server.com.
Iyo RAPTOR SERVER muenzaniso yakagadzirirwa kushanda kweSaaS uye saka inotsigira akawanda akazvimirira maroja. Mumwe nemumwe muroja anosiyaniswa zvine mutsindo kubva kune vamwe vese maroja uye hapana kuchinjana kwedata pakati pevaridzi kunogoneka neimwe nzira. Kana zviyero zvichifanira kutamiswa kubva kune mumwe muroja kuenda kune mumwe, zvinofanirwa kuitwa nesimba muRAPTOR SERVER Analysis Software.
Kuti uwane rumwe ruzivo nezveRAPTOR SERVER ndapota tarisa kune inoenderana Mirayiridzo Yekushandisa.
XVI.3 DOWNLOAD YEIMAGEXPLORER AGENT SOFTWARE UYE IMAGEXPLORER Tsanangudzo
Kuti umise ImageXplorer yemuroja wako, enda kunzvimbo yeTenant Admin uye tinya "Manage ImageXplorers". Kuti uwedzere ImageXplorer itsva, tapota sarudza "Wedzera ImageXplorer itsva" uye upe zita kwairi. ImageXplorer kiyi inogadzirwa otomatiki.
Mushure mekudzvanya pa "Save" iwe uchadzokera kune pamusoroview peji yeinoenderana ImageXplorer.
Pano iwe unotora iyo ImageXplorer Agent software.
Ita kuisirwa kweiyo ImageXplorer mumiriri, seyakajairwa yekuisa maitiro.
CHERECHEDZA: Kushandiswa kweImageXplorer kunoda kuvapo kwesoftware "Pylon Runtime 6.1.1, naBasler. Kana iwe ukaisa iyo "yakazara" vhezheni yeImageXplorer Agent, software inosanganisirwa. Kana iwe uchitova nesoftware iyi, zvakakwana kuisa iyo "slim" vhezheni yeSoftware.
CHERECHEDZA: Zvinokurudzirwa kubvisa chero imwe Pylon software kubva paPC usati waisa iyo ImageXplorer Agent, senge dzakapfuura shanduro dzePylon Runtime.
Kuti uvhure Agent uye ubatanidze kuImageXplorer uye RAPTOR SERVER, ndapota enda kune Zvirongwa uye nyora muRAPTOR SERVER. URL: https://www.raptor-server.com uye yako ImageXplorer Key uye tinya "Ramba".
A: Kubatanidza kuRAPTOR SERVER
B: Kubatanidza kuImageXplorer
Kana chinongedzo kune ese ari maviri RAPTOR SERVER uye ImageXplorer chikasimbiswa, ese ari maviri minda anosimbiswa negirinhi. Kana imwe yekubatanidza ikatadza, tarisa kune chikamu chekugadzirisa matambudziko kune mamwe mirairo.
Kana Log in yakabudirira, peji rekutanga reRAPTOR SERVER Analysis Software rinoratidza ne dashboard, iyo inosanganisira mitsva uye yakatenderwa kuyerwa mhinduro kubva kune yapfuura ALEX² uye FOX assay inomhanya paImageXplorer. uye zuva rekupedzisira ConfigXplorer scan uye/kana pamwedzi kugadzirisa (yeMAX zvishandiso chete).
XVI.4 KUKANGANISA ZVIMWE MAGEXPLORER SETTINGS
Imwe neimwe ImageXplorer ine yakasarudzika magadzirirwo emifananidzo inoda kuverengerwa uchishandisa ConfigXplorer panguva yekutanga kuisirwa uyezve mazuva makumi matanhatu ega ega.
Pakumisikidzwa kwekutanga kana pakutanga iyo itsva RAPTOR SERVER vhezheni kekutanga, hapana kuyerwa kunogona kuitwa neImageXplorer pasina ConfigXplorer scan.
Yese nyowani ImageXplorer sisitimu ichasanganisira calibration ConfigXplorer ine yakakosha barcode kutanga nenhamba "30" pane iyo label (semuenzaniso, 30AAF267). Iyo calibration array inounzwa muhomwe inovharika uye inofanirwa kugara ichichengetwa munzvimbo ine rima pakamuri tembiricha.
Mushure mekudzvanya "Gadzirisa" mumenyu "Manage ImageXplorers" unotungamirwa kunzvimbo kwaunogona kumhanyisa ConfigXplorer Scan.
Nekudzvanya pa "Tanga nyowani ConfigXplorer scan", iyo calibration yezvigadziriso-zvigadziriso zvinotanga (zvinotora anenge 1-2 maminetsi).
Iyi kuyerwa kwechiyero inozivisa uye kugadzirisa iyo yakakwana marongero e x, y, hupamhi uye kureba kwearongerwa edges uye kuratidzwa kwakanyanya. Kana kuverenga kwapera, mushumo weConfigXplorer Scan unoratidzwa. Mushandisi anozoisa iyo itsva ImageXplorer marongero nekudzvanya "Shandisa zvakaonekwa zvigadziriso."
CHERECHEDZA: Kana iyo calibration ConfigXplorer Scan ikabatikana uye ikasagadziridza mamiriro kwemaminetsi akati wandei, tinya pakubvisa. Pa peji rekugadzirisa reImageXplorer, tinya "Tanga ConfigXplorer scan" zvakare. Kana dambudziko iri rikaitika kwenguva refu, tarisa hukama hwako, sekutsanangurwa kwazvino muchitsauko XVI.10.
Kumhanyisa iyo ConfigXplorer Scan nguva nenguva kunovimbisa kuti ImageXplorer inoshandisa iyo yakakwana kumisikidzwa. Naizvozvo, mushure memazuva makumi matanhatu meseji ichaonekwa, iyo inokukurudzira kuti udzokorore iyo ImageXplorer ConfigXplorer Scan mukati memazuva makumi matatu.
Kana ukasadzokorora iyo ImageXplorer bvunzo, hapana zviyero zvitsva zvinogoneka mushure memazuva makumi mapfumbamwe. Zvapfuura zvichawanikwa sepakutanga.
Iwo azvino ImageXplorer marongero anowanikwa munzvimbo ye "Tenant Administration" -> "Manage ImageXplorers" -> "Gadzira". Kana iyo QR-Code isingazivikanwe panguva yeConfigXplorer Scan, yakajairwa "QR-Code Exposure" ye3.000 inogona kuwedzerwa.
Gadzirisa "Neuer Ⅸ
Iko Calibration configuration inogadziriswa ne "Shandisa otomatiki exposure", iyo inoramba iine 2500. Zvisinei, inogona kuiswa ku "Shandisa manual exposure". Neiyi modhi, kuratidzwa kunogona kugadziriswa kumusoro kana pasi. 
XVI.5 KUFANIRA UYE ONGORORO YEZVIYERO
XVI.5.1 KUPINDA CARTRIDGE MUIMAGEXPLORER
Iyo ImageXplorer ine nzira yekuisa yekuisa imwe yakagadziridzwa cartridge pane timinto mudziyo. Ngwarira tora katuriji (usabate membrane yekaturiji) pinza nekutarisana neQR-Code kune iyo MADx logo paImageXplorer mungoro.
Ita shuwa kuti cartridge yanyatsopinzwa mungoro uye hapana kumberi kana kuseri kwakasimudzwa (ona mifananidzo pazasi). Mushure mekuisa katuriji, vhara slider nekuifambisa mberi zvinyoro nyoro kusvika yamira. 
A: muteresi
B: ngoro
XVI.5.2 KUTORWA MUFANANIDZO, QR-CODE KUVERENGA UYE KUTSVAGA GRID
Pamusoroview peji iwe unowana tebhu "Zviyero zvitsva", tebhu "Zviyero zvakatenderwa", bhatani re "Tanga kuyerwa neImageXplorer" uye bhatani reMAX zvishandiso. Iyo tebhu "Zviyero zvitsva" ine ese matsva uye asina kubvumidzwa zviyero, iyo tebhu "yakatenderwa zviyero" ine ese akabvumidzwa zviyero.
Dzvanya pa "Tanga kuyerwa" muRAPTOR SERVER browser hwindo kuti uwane mufananidzo uye tanga iyo analytic kutevedzana. 
Kana chete ImageXplorer yakabatana, kuongororwa kunotanga nekukurumidza. Kana akati wandei ImageXplorers akabatana nemuroja paRAPTOR SERVER, mushandisi anofanira kutanga asarudza ImageXplorer yavanoda kushandisa. RAPTOR SERVER inoona otomatiki QRCode, inova hwaro hwezvese kugadziridzwa uye inopa iyo yakaonekwa QR-Code kuchiyero chitsva.
Chenjerera: Ziva kuti ndeipi ImageXplorer yauri kushandisa, kuve nemhedzisiro yebvunzo kumurwere akapihwa!
Iyo QR-Code pane yega katuriji ine ruzivo rwunotevera:
- rudzi rweyedzo array (ALEX2 / FOX)
- inoenderana allergen marongero
- QC ruzivo
- Nhamba yakawanda ye cartridge
Kuti uwane rumwe ruzivo nezve maficha eRAPTOR SERVER Analysis Software senge kugadzirisa mishumo uye kubvumidza / kutumira kunze zviyero ndapota tarisa kune inoenderana Mirayiridzo Yekushandisa.
XVI.6 INTERNAL QUALITY CONTROL
ALEX² nemakaturiji eFOX ane inbuilt assay run control, inomiririrwa neanonzi "Guide Dots" (GD) pamakona matatu pa cartridge surface. ALEX² cartridges inoshanda ne 3 Guide
Dots, nepo FOX cartridges inoshanda ne3 Guide Dots, muzvinzvimbo sezviri kuratidzwa pazasi. 
Munguva yekutorwa kwemufananidzo kweALEX² kana FOX cartridge, RAPTOR SERVER inoongorora chiratidzo cheese maDots anotungamira pamwe nechiratidzo chekumashure chemembrane surface. Kana maitiro ese emhando akazadzikiswa, iyo "otomatiki QC" ndima pasi pemufananidzo inoiswa ku "OK". Ndokumbira utarise iyo RAPTOR SERVER Analysis Software Instructions for Use kuti uwane rumwe ruzivo nezve QC yakasungirirwa pacartridge. Kana maitiro eQC asina kuzadzikiswa, ndapota taura nerutsigiro rweMADx kana muparidzi wenzvimbo yako. 
Pamusoro pezvo, zvinokurudzirwa kumhanyisa kanenge imwe isina kunaka uye imwe yakanaka yemhando yekudzora sample neyese assay run. RAPTOR SERVER ine yakakosha QC module inogona kutarisa QC kuita neiyo yekutengesa mhando yekudzora sample "Lyphochek® sIgE Control, Panel A" kubva kukambani Bio-Rad. Ndokumbira utarise Murairo Wekushandisa kubva kumugadziri wekushandisa iyi control material. Parizvino, iyo QC module muRAPTOR SERVER inongowanikwa yeALEX², kwete yeFOX.
MacroArray Diagnostics inopa mitsara yekubvuma kwechikwata chekupedzisira cheLyphochek® sIgE Control Panel A. Aya maitiro akachengetwa muRAPTOR SERVER uye haagoni kugadziriswa nemushandisi. Kuti ushandise Lyphochek® sIgE Kudzora Panel A seyemukati yemhando yekudzora panguva yekuongorora neImageXplorer, shandisa iyo nhamba yejenya ine inoenderera chigadzirwa ID "32" yekutonga sebhakodhi ye s.ample, semuenzanisoample “3222630” yeLyphochek® sIgE Control Panel A lot 22640. RAPTOR SERVER ichaziva iyi barcode seQC s.ample.
Kune mijenya #22640, anotevera allege uye miganho yekugamuchirwa yakafanotsanangurwa muRAPTOR SERVER yekuongorora software:
| Feature Name | Min Threshold | Max Threshold |
| Ara h 9 | 0.3 | 1.63 |
| Bheti v1 | 0.5 | 3.36 |
| Der p1 | 1.92 | 7.76 |
| FeI d1 | 3.98 | 12.33 |
| Phl p1 | 1.61 | 7.36 |
Mhedzisiro yeQC inogona kuwanikwa kubva kune ImageXplorer zvigadziriso peji ("System Admin" → Manage QC Lots").
Pamusoro pezvo, mhedzisiro yeConfigXplorer scan inogona kuwanikwa pane ImageXplorer zvigadziriso peji ("Tenant Admin" → "Manage ImageXplorers" → "Gadzira").
XVI.7 RUTSIGIRO RWOUnyanzvi
Kana iwe uine chero mibvunzo, zviitiko kana kuomerwa maererano neImageXplorer kana RAPTOR SERVER Analysis Software, ndapota taura nemugovera weko.
XVI.8 TECHNICAL DATA UYE ZVINODIWA
| Features | Parameters |
| Inowirirana Test Formats | ALEX² kana FOX cartridges |
| Cartridge Dimensions (W x D x H) | 53 x 18 x 7 mm |
| Maximum Scan Area (W x D) | 50 x 30 mm |
| Light Source | White light LED |
| Inoshanda Dyes | Colorimetric Dyes |
| Scan Resolution | Kusvika ku600 dpi |
| Scan Speed | CPU inotsamira, <5s per cartridge |
| Dynamic Range | 2.5 matanda |
| Kudzokorora | R² ≥ 99 %, CV ≤ 5 % |
| Focus Distance | 80 ± 10 mm |
| Image File Format | BMP 16 Bit |
| Voltage | 5V USB |
| Simba | <5 Watts |
| Features | Parameters |
| Magetsi | Chishandiso ichi chinofambiswa neiyo yakapihwa +5V USB 2.0 tambo kana USB 3.0. Hapana kuwedzera magetsi kunodiwa. |
| Saizi (W x D x H) | 160 x 180 x 180 mm |
| Kurema | 1.2 kg |
| Barcode Identification | QR-Kodhi |
| Operating System | PC ine MS Windows® 10 kana kupfuura |
| Inodiwa software (Inosanganisira izere vhezheni yeAgent installer) | Pylon Runtime v6.1.1 |
| Connection | USB 2.0 kana kupfuura |
| Temperature Range | Tembiricha yemumba (15 - 30°C) |
| Humidity | 30 - 85%, isina-condensing |
| Guruva | Nzvimbo isina guruva inokurudzirwa |
XVI.9 KUTARIRA
Iyo ImageXplorer chishandiso chine hunyanzvi chekufungidzira uye chinofanira kubatwa nemazvo. Kuti uwane mhedzisiro chaiyo, zvakakosha kuti chiridzwa chichengetedzwe chisina guruva zvakanyanya sezvinobvira. Kuti izvi zviitike, iyo yekunze ImageXplorer imba inofanirwa kugara ichicheneswa nejira-risina jira. Usashandise chero detergent pakuchenesa. Ngoro inobata makaturiji inogona kucheneswa zvakasiyana kana zvichidikanwa, uchishandisa mishonga yakapfava kana zvinodhaka.
USAvhura chiridzwa chassis!
XVI.10 KUTAMBURA
Zvikanganiso zvinotevera ndizvo zvakajairika uye saka zvinotsanangurwa pano zvakadzama.
Server Connection ku www.raptor-server.com zvakundikana (Mumiriri anoisa mureza mutsvuku)
Possible Solutions:
- Tarisa Indaneti
- Dzvanya marongero uye tarisa kana RAPTOR SERVER URL (www.raptor-server.com ndizvozvo
- Dzvanya marongero uye tarisa kana ImageXplorer kiyi yakarurama uye inoenderana neyakatsanangurwa kuMuroja paRAPTOR SERVER.
ImageXplorer Connection yakundikana (Agent inomira kubatanidza neruvara rutsvuku):
Possible Solutions:
- Tarisa kana ImageXplorer yakabatana pakombuta
- Batanidza zvakare ImageXplorer pakombuta (dhonza kunze uye plug mu USB tambo zvakare).
- Dzvanya marongero uye tarisa kana ImageXplorer kiyi yakarurama uye yakafanana neRAPTOR SERVER
Kutanga kuyerwa hazvigoneke:
Possible Solutions:
- Tarisa kana ImageXplorer yakabatana
- Tarisa kana iyo yekupedzisira inodiwa ConfigXplorer Scan yaitwa
Kana iwe uchiri kusangana nematambudziko kana uine chero mimwe mibvunzo kune zvigadzirwa uye masevhisi eMacroArray Diagnostics, ndapota taura nemugovera wako wepano.
©Copyright neMacroArray Diagnostics
MacroArray Diagnostics (MADx)
Lemböckgasse 59/Top 4
1230 Vienna, Austria
+43 (0)1 865 2573
www.macroarraydx.com
Nhamba yeshanduro: 11-IFU-01-EN-14
Zuva Rekubuda: 2022-12
MacroArray Diagnostics
• Lemböckgasse 59/Top 4
• 1230 Vienna
• macroarraydx.com
• CRN 448974 g
Zvinyorwa / Zvishandiso
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MUFANANIDZO PLORER Macro Array Diagnostics [pdf] Mirayiridzo Macro Array Diagnostics, Macro Array, Diagnostics |
