Ntuziaka maka ojiji

PLORER Macro Array Diagnostics

NKWUKWU

MacroArray Diagnostics akwadola ntuziaka enyere, reagents, ngwa, sọftụwia, na atụmatụ ahaziri maka onye nyocha a iji bulie arụmọrụ ngwaahịa yana izute nkọwa ngwaahịa. MacroArray Diagnostics anaghị akwado mgbanwe ndị akọwapụtara nke onye ọrụ n'ihi na ha nwere ike imetụta arụmọrụ onye nyocha yana nsonaazụ ule. Ọ bụ ọrụ dịịrị onye ọrụ ịkwado mgbanwe ọ bụla emere na ntuziaka ndị a, ngwa, reagents, ma ọ bụ sọftụwia nke MacroArray Diagnostics nyere.
Biko lelee ntuziaka ndị dị mkpa maka iji ule ALEX² na FOX tupu nhazi!

OKWU OBI

Edere ntuziaka a maka izi ezi. Ntuziaka na nkọwa maka ImageXplorer ziri ezi n'oge edere ntuziaka a. Ntuziaka na-esote nwere ike ịbụ
gbanwere na-enweghị ọkwa mbụ; Otú ọ dị, MacroArray Diagnostics anaghị ewere ụgwọ ọ bụla maka mmerụ ahụ kpatara ozugbo ma ọ bụ na-apụtaghị ìhè site na njehie sitere na ntuziaka ahụ. ImageXplorer bụ ngwaọrụ nchọpụta in-vitro nke e bu n'obi jiri naanị ndị ọrụ ụlọ nyocha zụrụ azụ.
Ikike nwebiisinka chekwara ntuziaka a na ngwanrọ akọwara. Ọ nweghị akụkụ nke ntuziaka a ma ọ bụ nke ngwanro akọwara nwere ike ịmegharị, megharịa, ma ọ bụ depụtaghachi ya na igwe eletrọnịkị ma ọ bụ usoro enwere ike ịgụ na-enweghị ikike ederede mbụ site na MacroArray Diagnostics.

Okwu na nkọwa

Mmebi	Mmeri anụ ahụ ma ọ bụ mmebi ahụike mmadụ, mmebi nke ngwaahịa ma ọ bụ gburugburu ebe obibi.
Ọrụ echere	Ịrụ ọrụ, gụnyere njikere maka ịrụ ọrụ, dị ka ntuziaka ọrụ si dị ma ọ bụ ihe e bu n'obi mee.
Ezubere iji	Iji ngwaahịa, usoro, ma ọ bụ ọrụ dabere na nkọwapụta na ntuziaka nke Macro Array Diagnostics (MADx) kọwapụtara.
Nbibi doro anya	Mmebi enwere ike iji anya gba ọtọ mara naanị site na nleba anya nke ọma nke onye nyocha ma ọ bụ ihe mejupụtara ya, ma ọ bụ site na nleba anya ihe ngosi, akara ma ọ bụ data ebufere.
Onye ọrụ	Onye ọ bụla ma ọ bụ otu na-ahụ maka ojiji na idobe ngwaọrụ ahụ. Onye na-ahụ maka ọrụ na-ahụ na a kụziere ndị ọrụ nke ọma maka otu esi eji ngwaọrụ ahụ arụ ọrụ.
Usoro	Akụrụngwa na mmemme ndị na-emekọrịta ihe iji gbanwee ntinye ka ọ bụrụ nsonaazụ.
Ndị ọrụ zụrụ azụ	Ndị ọrụ gụchara mmemme agụmakwụkwọ a ma ama maka ọrụ e kenyere ha, ndị maara akụkụ pụrụ iche na ihe egwu dị na gburugburu ebe ọrụ ha na ndị na-aga n'ihu na agụmakwụkwọ ha na ọzụzụ ọzụzụ oge niile gbasara mgbanwe na mmepe (dịka ụkpụrụ na ụkpụrụ nduzi) ndị metụtara agụmakwụkwọ ha na ọrụ ha.
Onye ọrụ	Onye na-eji ngwaọrụ ahụ dabere na nkọwapụta.
Nkwado	Nkwenye site n'inye ihe akaebe na-egosi na emezuola ihe achọrọ maka ojiji akọwapụtara nke ọma ma ọ bụ ngwa echekwabara.
Nyocha	Nkwenye site n'inye ihe akaebe na-egosi na emezuru ihe achọrọ.

Ezubere iji maka IMAGEXPLORER

ImageXplorer bụ ngwa na ebumnuche dị ka ngwa na ngwaahịa dabere na teknụzụ ALEX.
Ngwaahịa ahụike nke IVD na-enweta foto nke usoro teknụzụ ALEX nke dabeere na teknụzụ ma jiri ndị ọrụ ụlọ nyocha zụrụ azụ na ndị ọkachamara ahụike na ụlọ nyocha ahụike.

Onye nrụpụta na ịde aha

V.1 Onye nrụpụta
Mepụtara ImageXplorer site na MacroArray Diagnostics (MADx)
Ihe nchọpụta MacroArray
Lemböckgasse 59/ Top 4
A-1230 Vienna, Austria

V.2 IHE NGWỤRỤ NGWAỌWA
A na-edobe akara njirimara n'azụ ImageXplorer.

VI. Data arụmọrụ
VI.1 ASSAY CALIBRATION
Maka calibration nke Assay rụtụ aka na IFU nke ule ALEX² ma ọ bụ FOX.
VI.2 ONYE ATỤTA
Maka oke nha, rụtụ aka na IFU nke ule ALEX² ma ọ bụ Fox.

VI.3 njikwa ogo
Idekọ ndekọ maka nyocha ọ bụla:
Dị ka ezigbo ụlọ nyocha omume ọ na-atụ aro ka ịdekọ nza nọmba nke niile reagents eji. A na-echekwa ọtụtụ ọnụọgụ reagents maka ọsọ ọ bụla yana enwere ike weghachite ozi ahụ azụ azụ maka ID ọsọ ọ bụla site na RAPTOR SERVER Analysis Software.

Ụdị njikwa:
Dị ka ezigbo ụlọ nyocha a na-atụ aro ka njikwa mma sampA na-etinye les n'ime oge akọwapụtara. MacroArray Diagnostics na-enye ọkwa nnabata maka batches kachasị ọhụrụ nke Lyphochek® sIgE Control Panel A. A na-echekwa ụkpụrụ ndị a na RAPTOR SERVER na enweghị ike dezie ya site na onye ọrụ.
VI.4 Nyocha data
A na-enyocha onyonyo ALEX² na FOX ozugbo site na iji MADx's RAPTOR SERVER wee wepụta akụkọ na-achịkọta nsonaazụ maka onye ọrụ.
VI.5 nsonazụ
ALEX² bụ usoro ọnụọgụ maka IgE akọwapụtara yana usoro ọnụọgụ ọnụọgụ maka mkpokọta IgE. A na-akọwapụta ọgwụ mgbochi IgE kpọmkwem dị ka nkeji nzaghachi IgE (kUA/L), ngụkọta IgE dị ka kU/L. MADx's RAPTOR SERVER Analysis Software na-agbakọ na-akpaghị aka wee kọọ rịzọlt sIgE (n'ụzọ dị iche iche) na rịzọlt tIgE (n'obere ọnụọgụ).
FOX bụ usoro ọnụọgụ ọnụọgụ maka kpọmkwem IgG mkpebi. A na-akọwapụta ọgwụ mgbochi IgG akọwapụtara dị ka nkeji nzaghachi IgG (µg/ml). MADx's RAPTOR SERVER Analysis Software na-agbakọ na-akpaghị aka ma na-akọ rịzọlt sIgG ọkara n'otu n'otu dị ka klaasị (dị ala, etiti, na nke dị elu).

VI.6 Mbelata nke usoro
Maka oke nke usoro a na-ezo aka na IFU nke ule ALEX² ma ọ bụ ule FOX.
VI.7 URU NDỊ A GA-ECHICHE
Maka ụkpụrụ ndị a tụrụ anya na-ezo aka na IFU nke ule ALEX² ma ọ bụ ule FOX.

VI.8 ÀJỤMỤ ỌRỤ
Nnwale ALEX²:
Nkenkenke:
Maka nkenke, anyị na-ezo aka na njirimara arụmọrụ nke ngalaba na IFU nke ule ALEX².

Nkwughachi (nkenke n'ime ọsọ):
N'ime ọmụmụ ihe nkwugharị, ọtụtụ nwere mmetụta sampOtu onye ọrụ nwalere les ugboro iri n'ụbọchị dị iche iche. Ọmụmụ ihe ahụ nwere 10 allergens kwa sample nchikota
na-ekpuchi 165 onye allergens n'otu n'otu na ọkwa 3 dị iche iche (> 10 kUA / L, 1-10 kUA / L na 0.3-1 kUA / L).

Ntinye uche - kUA/L	Mgbakọta CV %
≥ 0.3 - <1.0	25.6
≥ 1 - <10	13.8
≥ 10	10.7
≥ 1	13.5

Mmetụta nyocha:
Maka oke nchọpụta, anyị na-ezo aka na njirimara arụmọrụ nke ngalaba na IFU nke ule ALEX².
Nkọwapụta gbasara nyocha:
Maka nkọwapụta nyocha, anyị na-ezo aka na njirimara arụmọrụ ngalaba na IFU nke ule ALEX².
Ntinye aka:
Maka nnyonye anya na ihe ndị ọzọ, anyị na-ezo aka na njirimara arụmọrụ nke ngalaba na IFU nke ule ALEX².

FOX ule
Nkenkenke (ọtụtụ dị iche iche):
Ekpebiri mgbanwe nza na nza na 3 cartridge nza na ọsọ atọ dị iche iche. Multisensitized samples e tinyere na ọmụmụ. Ọmụmụ ihe ahụ gụnyere 867 allergen/sampNchikota nke na-ekpuchi ihe nfụkasị ahụ 121 n'otu n'otu n'ofe nha niile.

Ntinye uche - µg/ml	Intra CV%	Inter CV%	Mgbakọta 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

Nkwughachi (nkenke n'ime ọsọ):
N'ime ọmụmụ ihe nkwugharị, ọtụtụ nwere mmetụta sampA nwalere les ugboro 10 site n'otu ọrụ ahụ n'ụbọchị dị iche iche. Ọmụmụ ihe ahụ nwere 862 antigen/sampNgwakọta ọnụ na-ekpuchi 115 antigens n'otu n'otu n'ofe nha niile.

Ntinye uche - µg/ml	Mgbakọta CV %
10.0-19.9	11.3
≥ 20	5.4
≥ 10	7.2

Mmetụta nyocha:
Maka njedebe nke nchọpụta, anyị na-ezo aka na njirimara arụmọrụ nke ngalaba na IFU nke ule FOX.
Ntinye aka:
Maka nnyonye anya na ihe ndị ọzọ, anyị na-ezo aka na njirimara arụmọrụ nke ngalaba na IFU nke ule FOX.

VII. Ụkpụrụ nke usoro
VII.1 ALEX² ỤLỌ Nnwale
ALEX² bụ usoro immunoassay siri ike. A na-edobe ihe ndị na-ekpo ọkụ na-ekpo ọkụ ma ọ bụ ihe nrịanrịa molekụla, nke jikọtara ya na nanoparticles, n'usoro ejiji n'usoro n'usoro siri ike, na-akpụ usoro macroscopic. Nke mbụ, allergens na-ejikọta urughuru na-emeghachi omume na kpọmkwem IgE nke dị na s onye ọrịa.ample. Mgbe emechara ya, a na-asachapụ IgE na-abụghị nke akọwapụtara. Usoro a na-aga n'ihu site n'ịgbakwunye enzyme akpọrọ mgbochi nchọpụta IgE mmadụ nke na-eme mgbagwoju anya nke nwere urughuru ejikọta kpọmkwem IgE. Mgbe usoro ịsa ahụ nke abụọ gasịrị, a na-agbakwunye mkpụrụ nke na-agbanwe ka ọ bụrụ ihe na-adịghị edozi ahụ, nke nwere agba site na enzyme na-egbochi mmadụ. N'ikpeazụ, a na-akwụsị mmeghachi omume enzyme-substrate site n'ịgbakwunye reagent na-egbochi ya. Ọnụọgụ mmiri ozuzo dabara na ntinye nke kpọmkwem IgE na s onye ọrịaample. Usoro nyocha na-esote site na inweta ihe onyonyo akpaaka na nyocha nke etinyere na ImageXplorer. A na-enyocha nsonaazụ ule ahụ site na ngwa MADx's RAPTOR SERVER Analysis Software wee kọwa ya na nkeji nzaghachi IgE (kUA/L). A na-akọkwa mkpokọta nsonaazụ IgE na nkeji nzaghachi IgE (kU/L).

VII.2 FOX ỤLỌ NCHE
FOX bụ immunoassay siri ike. A na-edobe ihe mpụta nri, nke jikọtara ya na nanoparticles, n'usoro n'usoro n'usoro n'usoro siri ike na-akpụ usoro macroscopic. Nke mbụ, protein ndị ejikọtaghị uru na-emeghachi omume na IgG akọwapụtara nke dị na s onye ọrịaample. Ka emechara ya, a na-asachapụ IgG na-abụghị nke akọwapụtara. Usoro a na-aga n'ihu site n'ịgbakwunye enzyme akpọrọ mgbochi nchọpụta IgG mmadụ nke na-eme mgbagwoju anya nwere urughuru ejikọta kpọmkwem IgG. Mgbe usoro ịsa ahụ nke abụọ gasịrị, a na-agbakwunye mkpụrụ nke na-agbanwe ka ọ bụrụ ihe na-adịghị edozi ahụ, nke nwere agba site na enzyme na-egbochi mmadụ. N'ikpeazụ, a na-akwụsị mmeghachi omume enzyme-substrate site n'ịgbakwunye reagent na-egbochi ya. Ọnụọgụ mmiri ozuzo dabara na ntinye nke IgG akọwapụtara na s onye ọrịaample. Usoro nyocha ụlọ nyocha na-esochi nweta ihe onyonyo akpaaka na nyocha nke etinyere na ImageXplorer. A na-enyocha nsonaazụ ule ahụ site na ngwa MADx's RAPTOR SERVER Analysis Software wee kọwa ya na µg/ml yana na klaasị IgG.

VIII. OZI
MacroArray Diagnostics ma ọ bụ ndị na-ekesa mpaghara dị maka ịrụzi ngwaọrụ n'oge awa ọrụ mpaghara. Ọ bụrụ na achọrọ ọrụ n'oge ọ bụla ọzọ, kpọtụrụ MacroArray Diagnostics service (support@macroarraydx.com) ma ọ bụ onye nkesa mpaghara gị. Agụnyere oke ọrụ ekwenyero na nkwekọrịta ọrụ gị.

IX. NKWUKWU
MacroArray Diagnostics na ndị na-ekesa mpaghara ya na-ekwe nkwa na ImageXplorer agaghị egosi ntụpọ ọ bụla n'oge arụ ọrụ ma ọ bụrụ na etinyere ya ma rụọ ọrụ dịka akwụkwọ ntuziaka a sitere n'aka ndị ọrụ ruru eru na ndị zụrụ azụ. Maka ozi ndị ọzọ gbasara akwụkwọ ikike, kpọtụrụ MacroArray Diagnostics service ma ọ bụ ndị nkesa ya. Akwụkwọ ikike ahụ abaghị uru maka mmebi nke na-eme n'ihi enweghị nnabata na akwụkwọ ntuziaka a, ebe a ga-arụzi ya na ịrụ ọrụ naanị site n'aka ndị zụrụ ma kwado ya site na MacroArray Diagnostics. Ekwesịrị ịrụ ọrụ nlekọta dịka akọwara n'akwụkwọ ntuziaka a. Ntinye aka na-ezighi ezi na ngwaọrụ a na-emebi akwụkwọ ikike ma nwee ike bute ụgwọ ọrụ. Jiri naanị ngwaọrụ dịka echere. Ọ bụrụ na ejighị ngwaọrụ ahụ dịka e bu n'obi, MacroArray Diagnostics na-ekwupụta ụgwọ niile maka mmebi nke onye nyocha.

Ozi inye iwu

Jiri naanị ihe eji eme ihe, ngwa na akụkụ mapụtara nke MacroArray Diagnostics nyere ma ọ bụ kwadoro ya. Nye iwu ihe ndị a naanị site na MacroArray Diagnostics ma ọ bụ mpaghara
ndị nkesa. Maka ịnye ozi, lee broshuọ MacroArray Diagnostics maka ImageXplorer anyị kpọtụrụ ndị otu MacroArray Diagnostics na orders@macroarraydx.com ma ọ bụ onye nkesa mpaghara gị.
Nọmba edemede MADx (REF) maka ImageXplorer bụ 11-0000-01.

XI. Ijikwa echekwabara
enyochala onye nyocha maka nchekwa teknụzụ tupu ebupu ya. Iji jikwaa ọkwa a yana ịhụ na ọ na-arụ ọrụ enweghị nsogbu:

• Soro ntuziaka dị n'akwụkwọ ntuziaka a mgbe niile.
• Na-agbaso ezigbo omume ụlọ nyocha mgbe niile.

Na mgbakwunye, MacroArray Diagnostics na-ekwu n'ụzọ doro anya na iji onye nyocha n'ụzọ akọwapụtaghị akwụkwọ ntuziaka a ma ọ bụ n'ebe ọzọ site na MacroArray Diagnostics nwere ike imetụta usoro nchekwa nke onye nrụpụta mebere ma nwee ike bute ọnọdụ dị ize ndụ ma ọ bụ bute nsonaazụ ule na-ezighi ezi.

XI.1 ỌRỤ ỌRỤ
Ekwesịrị ịrụ ọrụ ImageXplorer site na ma ọ bụ n'okpuru nlekọta nke onye ọrụ nka ma ọ bụ onye ọrụ nke tozuru oke maka ọrụ ụlọ nyocha. Tupu ị rụọ ọrụ ImageXplorer na RAPTOR SERVER Analysis software, onye ọrụ kwesịrị:

• Gụọ ntuziaka ndị a maka ojiji nke ọma
• Kpachara anya maka usoro ụlọ nyocha niile dị mkpa
• Mara iwu na ụkpụrụ nchekwa niile dị mkpa

Jiri nlezianya soro usoro akọwapụtara na ntuziaka ndị a maka ojiji maka ịrụ ọrụ na nhazi nke usoro. Nlekọta nke na-akọwaghị na ntuziaka maka ojiji kwesịrị ịhapụ ndị injinia ruru eru.

Emeghela ụlọ akụrụngwa!
Akụrụngwa eletrọnịkị nwere ike bụrụ isi iyi ọkụ eletrik!
Ọrụ na mmezi kwesịrị ịbụ naanị Macro Array Diagnostics ma ọ bụ ndị nkesa mpaghara ya ga-arụ ya.

XI.2 Nchekwa ọrụ
Dịka ọ dị n'usoro igwe ọ bụla, a ga-akpachapụ anya ụfọdụ mgbe ị na-arụ ọrụ onyonyo.

Ebukwala katrij nke iru mmiri ma ọ bụ mmiri mmiri!

Mmiri ọ bụla wụsara na ngwá ọrụ nwere ike ịkpata mmebi nke usoro ahụ. Ọ bụrụ na mmiri wụsara na ngwá ọrụ, hichapụ ya ozugbo wee kpọtụrụ nkwado teknụzụ.

XI.3 NKWAKWU
Maka ihe nchekwa, ImageXplorer ga-ekpochapụ / mebie ya tupu arụzi ọrụ na ọrụ ọrụ. Jide n'aka na ị gbasoro ntuziaka maka imetọ onye nyocha. Tupu ikpochapụ na/ma ọ bụ mkpochapụ, kwụpụ ihe nyocha na ọkụ ọkụ (dọrọ plọg). Onye na-ahụ maka ọrụ na-ahụ maka ịdị irè nke ụzọ mkpochapụ na mkpochapụ ejiri na nkwado ha.

XII. Nkọwa nkọwa

	Kpọtụrụ ntuziaka maka ojiji
	In vitro diagnostic ngwaọrụ ahụike
	akara CE
	Onye nrụpụta
	Nọmba usoro n'usoro
	Ngwa eletriki na igwe eletrọnịkị ihe mkpofu
	Ịkpachara anya

XIII. Ozi nchekwa
Ekwesịrị idobe ozi nchekwa niile ka ịzenarị ọnọdụ dị ize ndụ nke nwere ike bute ọnwụ, mmerụ ahụ ma ọ bụ mebie akụrụngwa.

Na-egosi ọnọdụ dị ize ndụ, ma ọ bụrụ na ewepụghị ya, ga-ebute ọnwụ, nnukwu mmerụ ahụ ma ọ bụ obere.

XIV. NKWUO IWU
XIV.1 Ọkọlọtọ mba ụwa
Ewupụtala ImageXplorer, nwale ma rụpụta ya dịka nke siri dị
EN ISO 13485, EN IEC 61010-2-101, EN ISO 14971, EN IEC 61326-2-6, EN ISO 62304 na EN ISO 62366.

XIV.2 CE NKWUKWU
ImageXplorer na-ejide akara CE nke na-egosi na ngwaọrụ ndị ahụ na-emezu ihe ndị dị mkpa nke iwu European ndị a:

• Ntuziaka ngwaọrụ ahụike na Vitro Diagnostic 98/79/EC
• Ntuziaka maka ngwa eletrik na eletrọnịkị na-ekpofu 2012/19/EU
• Ntuziaka na mmachi nke ihe dị ize ndụ 2011/65/EC

XIV.3 ELECTROMAGNETIC COMPATIBILITY (EMC), RADIO INTERFERENCE SPRESSESSE AND IMMUNITY TO INTERFERENING.
A nwalere ImageXplorer dị ka EN IEC 61326-2-6 si kwekọọ na CISPR 11 Klas B.
XV. OKIRIKIRI NDỤ
Akụkụ a na-akọwa stages ImageXplorer na-agafe, na-amalite site na nnyefe gaa na mkpofu, yana ihe achọrọ maka onye ọrụ n'ime s ọ bụla.tage.

XV.1 NKEWA
XV.1.1 emebi emebi n'oge njem
Nkwakọ ngwaahịa dị n'èzí nke ImageXplorer na-eme ka nchebe kachasị mma ghara imebi njem. Ka o sina dị, biko lelee mbupu ọ bụla ozugbo enwetara ya maka mmebi ụgbọ njem a na-ahụ anya. Ọ bụrụ na ịnata mbupu ezughi oke ma ọ bụ mebiri emebi, biko kpọtụrụ MacroArray Diagnostics ma ọ bụ onye nkesa mpaghara gị ozugbo. Biko mee ka onye na-ebu ya mara maka mmebi pụtara ìhè.

XV.1.2 OKPUKPỤTA NKEfe

Ihe gụnyere

1 x ImageXplorer

1 x ImageXplorer ibu

1x eriri njikọ (PC na ImageXplorer)

Tebụl 1 Ndepụta ihe dị maka ibuga

Maka ịrụ ọrụ nke ngwaọrụ ahụ, a chọrọ ALEX² (50x: REF 02-5001-01 ma ọ bụ 20x: REF 02-2001-01) ma ọ bụ FOX (REF 80-5001-01) ngwa nyocha, nke anaghị etinye na mbupu nke ImageXplorer na a ga-enyerịrị ya iwu iche.

XV.2 Mwepu
Na European Union, a na-ahazi mkpofu onye nyocha site na ntuziaka 2012/19/EU maka ngwa eletriki na ngwa eletrọnịkị (WEEE) na ntụgharị mba kwekọrọ.
MacroArray Diagnostics agba mbọ iweghachite ma megharịa ngwa eletriki na eletrọnịkị na mpaghara ebe etinyere ntuziaka a kpọtụrụ aha n'elu.
N'ebe a na-akwadoghị ntuziaka a kpọtụrụ aha n'elu, kpọtụrụ MacroArray Diagnostics service ma ọ bụ onye nkesa mpaghara gbasara mkpofu onye nyocha.
Dabere na ngwa ndị a, akụkụ nke onye nyocha nwere ike iji ihe dị ndụ ma ọ bụ kemịkalụ dị ize ndụ metọọ.

Na-emeso ihe emetọọ dịka ụkpụrụ na ụkpụrụ obodo na mpaghara siri dị. Tupu ebuga ma ọ bụ mkpofu, kpochapụ akụkụ nke ihe nyocha nwere ike metọọ dịka ụkpụrụ na ụkpụrụ obodo na mpaghara siri dị. Ọ bụrụ na ịchọrọ enyemaka, kpọtụrụ MacroArray Diagnostics ma ọ bụ onye nkesa mpaghara.
Ejila ngwa eletriki na eletrọnịkị dị ka ihe mkpofu nke ime obodo anaghị ahazi wee lelee onye na-ahụ maka mkpofu mkpofu mpaghara gị maka ihe a kapịrị ọnụ gbasara mkpofu. Biko kpokọta ngwa eletriki na ngwa eletrọnịkị dị iche iche wee weghachi ha na MacroArray Diagnostics ma ọ bụ onye nkesa mpaghara na mpaghara ebe etinyere ntuziaka a kpọtụrụ aha n'elu.

Ndabere data XV.3
Mgbe ị na-eji RAPTOR SERVER Analysis Software, a na-echekwa data nyocha na ndị ọrịa dịka Usoro Agreement Ọrụ MADx na Microsoft Azure Online Portal. Biko rụtụ aka na Usoro Ọrụ Ọnlaịnụ (OST) nke Microsoft, dị na https://www.microsoft.com/en-us/licensing/product-licensing/products. Maka ụdị RAPTOR SERVER, biko kpọtụrụ onye nchịkwa IT mpaghara gị.

XVI. Nkọwa

A: chassis
B: slide
C: ibu

Akụkụ sistemụ dị mkpa nke ImageXplorer bụ:

• CCD (ngwaọrụ jikọtara chaja) Igwefoto maka inweta onyonyo
• bọọdụ sekit ọkụ ọkụ ikanam
• Ụgbọ ala maka ịtinye katrij
• Stage n'ihi na slide ihe njide katrij
• USB 2.0 ma ọ bụ eriri USB 3.0

XVI.1 na-ejikọta ihe oyiyi na PC
ImageXplorer abụghị ngwaọrụ kwụụrụ onwe ya, a ga-ejikwa ya na ngwa RAPTOR SERVER Analysis Software. A na-agbanye ImageXplorer na kọmputa site na eriri USB 2.0 ma ọ bụ USB 3.0 enyere, ma njikọ ahụ na ike ọkụ na-ejikwa site na ọdụ USB 3.0 nke kọmputa site na eriri USB enyere.
Mara: Enwere ike iji ngwaọrụ ahụ na ọdụ ụgbọ USB 2.0, mana nyocha ahụ ga-achọ ogologo oge n'ihi ọnụego nnyefe data dị ala.

XVI.2 RAPTOR SERVER SOFTWARE Nhazi
A na-atụ aro Google Chrome ka ọ bụrụ ihe nchọgharị maka iji RAPTOR SERVER. Enwere ike ịnweta interface onye ọrụ eserese nke RAPTOR SERVER na websaịtị:
https://www.raptor-server.com.
Emebere ihe atụ RAPTOR SERVER maka ịrụ ọrụ SaaS, yabụ na-akwado ọtụtụ ndị nwe ụlọ nọọrọ onwe ha. Onye ọ bụla bi n'ụlọ nwere ezi uche dị iche iche na ndị ọzọ niile nwe ụlọ na ọ dịghị mgbanwe nke data n'etiti ndị nwe ụlọ ga-ekwe omume n'ụzọ ọ bụla. Ọ bụrụ na ekwesịrị ibufe nha site n'otu onye nwe ụlọ gaa na nke ọzọ, a ga-eme ya nke ọma na ngwa nyocha RAPTOR SERVER Analysis.
Maka ozi ndị ọzọ na RAPTOR SERVER biko rụtụ aka na ntuziaka dabara adaba maka ojiji.

XVI.3 Nbudata nke IMAGEXPLORER Agent SOFTWARE NA Nkọwa nke IMAGEXPLORER
Ka ịtọlite ​​​​ImageXplorer maka onye nwe ụlọ gị, gaa na mpaghara Admin Tenant wee pịa "Jikwaa ImageXplorers". Ka ịgbakwunye ImageXplorer ọhụrụ, biko họrọ "Tinye ImageXplorer ọhụrụ" wee kenye ya aha. A ga-ewepụta igodo ImageXplorer na-akpaghị aka.

Mgbe ịpịrị "Save" ị ga-alaghachi na n'eluview ibe nke ImageXplorer.
N'ebe a, ị ga-ebudata ngwanro Agent ImageXplorer.

Mepụta ntinye nke onye nnọchi anya ImageXplorer, dị ka usoro nrụnye oge niile.
IHE: Ojiji nke ImageXplorer chọrọ ọnụnọ nke ngwanrọ "Pylon Runtime 6.1.1, nke Basler. Ọ bụrụ na ị wụnye ụdị "zuru ezu" nke ImageXplorer Agent, software gụnyere.
IHE: A na-atụ aro ka iwepu sọftụwia Pylon ọ bụla na PC tupu ịwụnye Agent ImageXplorer, dị ka ụdị nke Pylon Runtime gara aga.
Iji mee ka Agent rụọ ọrụ wee jikọọ ya na ImageXplorer na RAPTOR SERVER, biko gaa na Ntọala wee pịnye na RAPTOR SERVER. URL: https://www.raptor-server.com na igodo ImageXplorer gị wee pịa "Gaa n'ihu".

A: Njikọ na RAPTOR SERVER
B: Njikọ na ImageXplorer

Ọ bụrụ na etinyere njikọ na SERVER RAPTOR na ImageXplorer, a na-eme ka mpaghara abụọ ahụ pụta ìhè na akwụkwọ ndụ akwụkwọ ndụ. Ọ bụrụ na otu njikọ ada ada, rụtụ aka na ngalaba nchọpụta nsogbu maka ntuziaka ndị ọzọ.
Ọ bụrụ na nbanye ahụ gara nke ọma, ibe mbụ nke RAPTOR SERVER Analysis Software na-egosi na dashboard, nke gụnyere nsonaazụ nha ọhụrụ na akwadoro sitere na ALEX² gara aga na FOX assay na-agba na ImageXplorer. yana ụbọchị nyocha ConfigXplorer ikpeazụ na/ma ọ bụ mmezi kwa ọnwa (maka naanị ngwaọrụ MAX).

XVI.4 na-edozi ntọala imagexPLORER
Onye ọ bụla ImageXplorer nwere ntọala onyonyo pụrụ iche nke kwesịrị ịhazi ya site na iji ConfigXplorer n'oge nrụnye mbụ yana ụbọchị 60 ọ bụla.
Na ntinye nke mbụ ma ọ bụ na ịmalite ụdị RAPTOR SERVER ọhụrụ maka oge mbụ, enweghị ike iji ImageXplorer mee nha na-enweghị nyocha ConfigXplorer.

Sistemu ImageXplorer ọhụrụ ọ bụla ga-agụnye nhazi nhazi ConfigXplorer nwere koodu mgbochi pụrụ iche na-amalite site na ọnụọgụ "30" na labelụ (dịka, 30AAF267). A na-ebunye nhazi nhazi ahụ n'ime obere akpa a na-emegharịgharị ma na-echekwa ya mgbe niile n'ebe gbara ọchịchịrị n'ime ụlọ okpomọkụ.
Mgbe ịpịrị "Hazie" na menu "Jikwaa ImageXplorers" a na-eduzi gị na mpaghara ebe ị nwere ike ịme nyocha ConfigXplorer.

Site na ịpị “Malite nyocha ConfigXplorer ọhụrụ”, nhazi nhazi ntọala na-amalite (na-ewe ihe dịka nkeji 1-2).

Ntụzi nhazi a ga-achọpụta ma mezie ntọala kacha mma maka x, y, obosara na ịdị elu nke akụkụ nhazi yana mkpughe kacha mma. Mgbe agbakọchara, a ga-egosipụta akụkọ nyocha ConfigXplorer. Onye ọrụ ga-etinye ntọala ImageXplorer ọhụrụ site na ịpị "Tinye ntọala achọpụtara."
IHE: Ọ bụrụ na calibration ConfigXplorer Scan na-arapara na anaghị emelite steeti maka nkeji ole na ole, pịa ime. Na ibe nhazi nke ImageXplorer, pịa "Malite nyocha ConfigXplorer" ọzọ. Ọ bụrụ na nsogbu a emee n'ime ogologo oge, lelee njikọ gị, dịka akọwara na isi XVI.10.

Na-agba ọsọ nyocha ConfigXplorer mgbe niile ga-ahụ na ImageXplorer na-eji nhazi kachasị mma. Ya mere, mgbe ụbọchị 60 gasịrị ozi ga-apụta, nke na-akpali gị ịmegharị ImageXplorer ConfigXplorer Scan n'ime ụbọchị 30.

Ọ bụrụ na ịmegharịghị ule ImageXplorer, ọ nweghị nha ọhụrụ ga-ekwe omume mgbe ụbọchị 90 gachara. A ga-enweta nsonaazụ gara aga dịka ọ dị na mbụ.
A ga-achọta ntọala ImageXplorer dị ugbu a na mpaghara "Nchịkwa Tenant" -> "Jikwaa ImageXplorers" -> "Hazie". Ọ bụrụ na amataghị koodu QR n'oge nyocha ConfigXplorer, enwere ike ịbawanye ọkọlọtọ "Nkpughere koodu QR" nke 3.000.

Hazie “Neuer Ⅸ

A na-edozi nhazi calibration na ndabara ka "Jiri ikpughe akpaka", nke na-anọ maka mkpughe nke 2500. Otú ọ dị, enwere ike ịtọ ya "Jiri ikpughe akwụkwọ ntuziaka". Site na ọnọdụ a, enwere ike idozi mkpughe ahụ elu ma ọ bụ ala. XVI.5 ONYIYI NA NKWUO NKE ỌCHỊ
XVI.5.1 Ịtinye katridge n'ime ihe oyiyi
ImageXplorer nwere usoro ntinye maka ịkwanye otu katrij a na-ahazi na timinto ngwaọrụ. Jiri nlezianya were katrij (emetula akpụkpọ ahụ nke katrij) tinye ya site na iche ihu koodu QR na akara MADx na ImageXplorer n'ime ụgbọ mmiri ahụ.
Jide n'aka na etinyere katrijị ahụ kpamkpam n'ime ụgbọ ma ọ bụghị n'ihu norin azụ weliri elu (lee foto dị n'okpuru). Mgbe ịtinyechara katrij, mechie ihe mmịfe ahụ site na ibugharị ya nwayọ ruo mgbe ọ kwụsịrị. A: mmịfe
B: ibu
XVI.5.2 Nnweta onyonyo, Ọgụgụ QR na Nchọta grid
Na n'eluview ibe ị ga-ahụ taabụ “Ntụnye ọhụrụ”, taabụ “Ntụnye akwadoro”, bọtịnụ maka “Malite nha na ImageXplorer” yana bọtịnụ maka ngwaọrụ MAX. Taabụ “ntụgharị ọhụrụ” nwere nha ọhụrụ na enweghị nkwado, taabụ “atụ akwadoro” nwere nha niile akwadoro ruo ugbu a.
Pịa na "Malite Measurement" na windo ihe nchọgharị RAPTOR SERVER iji nweta onyonyo wee malite usoro nyocha. Ọ bụrụ na ejikọrọ naanị otu ImageXplorer, nyocha ga-amalite ozugbo. Ọ bụrụ na ejikọrọ ọtụtụ ImageXplorers na onye nwe ụlọ na RAPTOR SERVER, onye ọrụ ga-ebu ụzọ họrọ nke ImageXplorer ha chọrọ iji. SERVER RAPTOR na-amata QRCode na-akpaghị aka, nke bụ ntọala nhazi niile ma kenye koodu QR achọpụtara na nha ọhụrụ.
Nlebara anya: Mara nke ImageXplorer ị na-eji, iji nweta nsonaazụ ule ziri ezi maka onye ọrịa nyere!
Koodu QR na katrij ọ bụla nwere ozi ndị a:

• ụdị ule n'usoro (ALEX2 / FOX)
• nhazi ihe nfụkasị ahụ kwekọrọ
• Ozi QC
• Ọnụ ọgụgụ nke katrij

Maka ozi ndị ọzọ gbasara atụmatụ RAPTOR SERVER Analysis Software dị ka ịhazi akụkọ na ịkwado / mbupụ nha biko rụtụ aka na ntuziaka maka ojiji.

XVI.6 njikwa ogo dị n'ime

Katrij ALEX² na FOX nwere njikwa ọsọ nyocha arụnyere arụnyere, nke akpọrọ “Ntuzi Ntuzi” (GD) nọchiri anya n'akụkụ atọ n'elu katrij. ALEX²cartridges na-arụ ọrụ na ntuziaka 3
Ntụpọ, ebe katrij FOX na-arụ ọrụ na ntụpọ ntụzịaka 3, n'ọnọdụ dị ka egosiri n'okpuru.
N'oge a na-enweta foto nke ALEX² ma ọ bụ FOX katrij, RAPTOR SERVER na-enyocha akara ngosi ntụzịaka niile yana mgbama ndabere nke elu akpụkpọ ahụ. Ọ bụrụ na emezuru njirisi ogo niile, a ga-edobe mpaghara “QC akpaaka” n'okpuru onyonyo a ka ọ bụrụ “OK”. Biko kpọtụrụ RAPTOR SERVER Analysis Software Ntuziaka maka ojiji maka ozi ndị ọzọ gbasara QC jikọtara na katrij. Ọ bụrụ na emezughị njirisi QC, biko kpọtụrụ nkwado MADx ma ọ bụ onye nkesa mpaghara gị.

Na mgbakwunye, a na-atụ aro ka ị na-agba opekata mpe otu adịghị mma yana otu njikwa mma dị mmaample na nyocha ọ bụla na-agba ọsọ. SERVER RAPTOR nwere modul QC bụ isi nke nwere ike nyochaa arụmọrụ QC na njikwa mma azụmahịa sample "Lyphochek® sIgE Control, Panel A" nke ụlọ ọrụ Bio-Rad. Biko kpọtụrụ ntuziaka maka ojiji sitere n'aka onye nrụpụta maka otu esi eji ihe njikwa a. Ugbu a, modul QC na RAPTOR SERVER dị naanị maka ALEX², ọ bụghị maka FOX.
MacroArray Diagnostics na-enye ọkwa nnabata maka ogbe njikwa Lyphochek® sIgE kachasị ọhụrụ A. A na-echekwa ụkpụrụ ndị a na RAPTOR SERVER na onye ọrụ enweghị ike dezie ya. Iji jiri Lyphochek® sIgE Control Panel A dị ka njikwa mma dị n'ime n'oge nyocha na ImageXplorer, jiri nọmba nza na ID ngwaahịa na-aga n'ihu "32" nke njikwa dị ka koodu nzuzo maka s.ample, maka example “3222630” maka Lyphochek® sIgE Control Panel A otutu 22640. RAPTOR SERVER ga-amata nke a barcode dị ka QC s.ample.
Maka nza #22640, akọwapụtala ihe nrịanrịa na oke nnabata na ngwa nyocha RAPTOR SERVER:

Aha njirimara	Ọnụ ụzọ Min	Oke oke
nke h 9	0.3	1.63
Nzọ v 1	0.5	3.36
Nke p1	1.92	7.76
FeI d 1	3.98	12.33
Phl p1	1.61	7.36

Enwere ike nweta nsonaazụ QC site na ibe ntọala ImageXplorer ("Admin System" → Jikwaa QC Lots").
Na mgbakwunye, enwere ike ịhụ nsonaazụ nke nyocha ConfigXplorer na ibe ntọala ImageXplorer (“Tenant Admin” → “Jikwaa ImageXplorers” → “Hazie”).

XVI.7 Nkwado nka nka
Ọ bụrụ na ị nwere ajụjụ ọ bụla, ahụmịhe ma ọ bụ ihe isi ike gbasara ImageXplorer ma ọ bụ RAPTOR SERVER Analysis Software, biko kpọtụrụ onye nkesa mpaghara gị.

XVI.8 data nka na ihe achọrọ

Atụmatụ	Oke
Ụdị ule dakọtara	ALEX² ma ọ bụ FOX katrij
Akụkụ katrijị (W x D x H)	53 x 18 x 7 mm
Mpaghara nyocha kacha (W x D)	50 x 30 mm
Isi Iyi Ìhè	Ọcha ọkụ ọkụ
Ihe eji agba agba	Agba agba agba
Nyochaa mkpebi	Ruo 600 dpi
Nyochaa ọsọ	CPU dabere, <5 s kwa katrij
Oke dị ike	2.5 ndekọ
Nkwagharị ugboro ugboro	R² ≥ 99 %, CV ≤ 5 %
Ogologo anya	80 ± 10 mm
Onyonyo File Usoro	BMP 16-bit
Voltage	5V USB
Ike	<5 Watts

Atụmatụ	Oke
Ịnye ọkụ	A na-akwado ngwaọrụ a site na eriri USB 5 + 2.0V ma ọ bụ USB 3.0. Ọnweghị ọkụ ọkụ ọzọ achọrọ.
Nha (W x D x H)	160 x 180 x 180 mm
Ibu	1.2 n'arọ
Njirimara Barcode	Koodu QR
Sistemụ nrụọrụ	PC nwere MS Windows® 10 ma ọ bụ karịa
Akụrụngwa achọrọ (gụnyere ya na ụdị installer Agent zuru ezu)	Oge ịgba ọsọ Pylon v6.1.1
Njikọ	USB 2.0 ma ọ bụ karịa
Oke okpomọkụ	Okpomọkụ ụlọ (15-30°C)
iru mmiri	30 - 85%, enweghị condensing
Uzuzu	akwadoro gburugburu enweghị uzuzu

XVI.9 Nkwadebe
ImageXplorer bụ ngwaọrụ onyonyo nwere mmetụta na ekwesịrị ijikwa ya nke ọma. Maka nsonaazụ ziri ezi, ọ dị mkpa ka a na-edobe ngwa ahụ n'enweghị uzuzu dị ka o kwere mee. Iji mezuo nke a, a ga-eji akwa akwa na-enweghị lint na-ehicha ụlọ obibi ImageXplorer dịpụrụ adịpụ mgbe niile. Ejila ncha ọ bụla maka nhicha. Enwere ike ihicha ụgbọ mmiri nke na-ejide katrijị iche iche ma ọ dị mkpa, na-eji ncha dị nro ma ọ bụ ihe ọṅụṅụ mmanya.

Emeghela chassis akụrụngwa!

XVI.10 Nchọpụta nsogbu
Njehie ndị a bụ nke a na-ahụkarị ma ya mere akọwara ebe a n'ụzọ zuru ezu karị.
Njikọ sava na www.raptor-server.com dara (njikọ ọkọlọtọ ndị nnọchi anya na agba uhie)

Ngwọta enwere ike:

• Lelee njikọ ịntanetị
• Pịa ntọala wee lelee ma RAPTOR SERVER URL (www.raptor-server.com ziri ezi
• Pịa ntọala wee lelee ma igodo ImageXplorer ziri ezi ma dabara na nke akọwapụtara maka Tenant na RAPTOR SERVER.

Njikọ ImageXplorer dara (njikọ ọkọlọtọ ndị nnọchi anya na agba uhie):

Ngwọta enwere ike:

• Lelee ma ImageXplorer ejikọrọ na kọmputa
• Jikọọ ImageXplorer na kọmpụta (wepụ ma tinye eriri USB ọzọ).
• Pịa ntọala wee lelee ma igodo ImageXplorer ziri ezi yana otu dị na SERVER RAPTOR

Ntụle mmalite agaghị ekwe omume:

Ngwọta enwere ike:

• Lelee ma ImageXplorer ejikọrọ
• Lelee ma ọ bụrụ na emechara nyocha ConfigXplorer ikpeazụ achọrọ

Ọ bụrụ na ị ka nwere nsogbu ma ọ bụ nwee ajụjụ ọ bụla ọzọ maka ngwaahịa na ọrụ nke MacroArray Diagnostics, biko kpọtụrụ onye nkesa mpaghara gị.

©Nwebiisinka nke MacroArray Diagnostics
Ihe nchọpụta MacroArray (MADx)
Lemböckgasse 59/ Top 4
1230 Vienna, Austria
+43 (0)1 865 2573
www.macroarraydx.com
Nọmba ụdị: 11-IFU-01-EN-14
Ụbọchị mbipụta: 2022-12

Ihe nchọpụta MacroArray
• Lemböckgasse 59/ Top 4
• 1230 Vienna
• macroarraydx.com
• CRN 448974 g

Akwụkwọ / akụrụngwa

IMAGE PLORER Macro Array Diagnostics [pdf] Ntuziaka Nchọpụta ọrịa macro Array, Macro Array, Diagnostics

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