Imbonerahamwe
Uruganda rwa XBX colonoscope rusobanurwa nibikoresho byo mu rwego rwubuvuzi, ISO 13485 n’umusaruro ucungwa n’ibyago, 100% ya kalibrasi ya optique n’amashanyarazi, hamwe n’urwego rukurikirana; ibyuma bifata amashusho, ibice byunamye, hamwe numuyoboro wa biopsy bikozwe munsi yumurongo ugenzurwa na SPC, kubwibyo amashusho ahoraho yo kwisuzumisha hamwe nigihe kirekire cya serivisi atangwa mugihe cyo gusana no kugitunga bigabanuka kubitaro.
Ku ruganda rwa XBX colonoscope, ibisobanuro byinjijwe muri buri ntambwe. Urwego rufunze-ruzengurutse ubuziranenge rwashyizweho kugirango kwemeza ibishushanyo, kugenzura byinjira, kugenzura ibikorwa, no kugerageza ibikoresho byarangiye bihujwe na digitale. Ubu buryo bwakoreshejwe kugirango harebwe imikorere isubirwamo hifashishijwe ibikoresho bya colonoskopi no gushyigikira ubugenzuzi bwibitaro bifite ibyangombwa bisobanutse. Ugereranije nibicuruzwa bisanzwe, kwihanganira gukomeye hamwe no kwipimisha mugari kumurongo byakoreshejwe, bityo drift mumashusho cyangwa kurakara bibaho gake cyane mugukoresha amavuriro.
Iyimurwa ryibishushanyo bigengwa ningaruka zishingiye kuri DMR, bityo ibintu byingenzi biranga umuyoboro winjizamo, igice cyunamye, hamwe ninama ya kure birindwa mugihe cyo gupima.
Igenzura ryinjira rikorwa kuri coil idafite ingese, inshundura zometseho, ikirahure cya optique, sensor ya CMOS, na polymers yubuvuzi; Ibipimo bya Cpk byubahirizwa kugirango itandukaniro rigabanuke.
Igenzura rikorwa hamwe na AOI kumanota yagurishijwe, ibizamini bya helium kumiyoboro, ikarita ya torque-bend mapping ya articulation, hamwe na lumen patensi yo kuhira no guswera.
Kugenzura ibicuruzwa byarangiye bikorwa hamwe na 4K yerekana amashusho ya endoscope, ibizamini byo kumurika, kugenzura IPX7, no kwemeza kwihanganira uburebure.
Ibikoresho bya endoscope yubuvuzi bifite igipimo kinini cyo kwambara byazamuwe. Igice cyo kugunama giteranijwe hamwe n’umuyoboro udashobora kwihanganira umunaniro, kandi ikoti ryinjizwamo ikoti ryakozwe hamwe na polymers abrasion-optimiz. Imiyoboro ya biopsy ifite friction nkeya yatoranijwe kugirango igabanye imbaraga mugihe ibikoresho bya endoskopique byateye imbere, bityo ihahamuka rya mucosal ntirishoboka. Ibicuruzwa bisanzwe bikunze gushingira kuri rusange-intego ya tubing; Ibinyuranyo, ubufindo bwibikoresho bya XBX bujuje ibisabwa mugihe cyogusukura kugirango bigaragaze igihe cyo kubaho mubitaro nyabyo.
Kumenyekanisha cyane CMOS kwakoreshejwe kugirango amashusho yerekana urusaku ruke. Impuzandengo yera itajegajega hamwe nibisobanuro byamabara bigenzurwa nimbonerahamwe. Urutonde rwa videwo ya endoskopi-kuva kuri sensor kugeza kuri sisitemu ya endoscope-yatunganijwe kuburyo intera igenda ibikwa mubice bitagaragara. Inkomoko yumucyo isohoka hamwe na fibre guhuza byapimwe kuburyo umucyo ukomeza kuba mwiza kumunsi wakazi. Iyo kamera ya 4K ya endoscope ikoreshwa, ubukererwe buragabanuka kugirango ushyigikire polypectomy.
ISO 13485 gukora no ISO 14971 gucunga ibyago byashyizwe mubikorwa mumirongo y'uruganda rwa colonoscope.
UDI ikurikirana hamwe na DHR byuzuye byakomeje gushyigikirwa nubugenzuzi nitsinda ryamasoko yibitaro.
Amakuru ya biocompatibilité kubikoresho-byandikirwa abarwayi aragumana kugirango ibibazo byubwubatsi byubuvuzi bisubizwe vuba.
Inyandiko zikoreshwa zikoreshwa zunganira umutekano wumukoresha no kugabanya igihe cyamahugurwa kubakozi bashya.
Itandukaniro ryizewe ryagaragaye mubipimo byakusanyijwe nyuma yo kunoza imikorere. Ibicuruzwa bisanzwe bikunze koherezwa hamwe no gupima ibizunguruka. Kuri XBX, buri moderi ya colonoscope igeragezwa numunaniro hejuru y ibahasha yuzuye; kunama gukomera byashushanijwe kandi byandikwa, kandi ibisubizo hanze yumugenzuzi bigashyirwa mu kato. Ingaruka zabyo, ububiko bwa shaft hamwe na deflection asimmetrie bigabanuka nyuma yo gusubiramo inzinguzingo, kandi amashusho agumaho.
Igihe kiri hagati yibikorwa bya serivisi cyongerewe hakoreshejwe imipira yimbaraga ya kure hamwe nudusanduku twazamuye twapimwe kugirango tumenye neza.
Ibikoresho by'ibikoresho hamwe na modular subassemblies byashyizweho kugirango bigabanye igihe cyo guhinduka mubigo byemewe bya serivisi.
Kuberako uburyo bwo kunanirwa buteganijwe hamwe na FMEA kandi bugakurikiranwa na SPC, hashobora gutegurwa abasimbura kwirinda, bikagabanya igihe cyo gutungurana kubice bya gastroenterology.
Kwambara kumyenda ya kashe na kashe bigabanywa nubuso bugenzurwa burangirira imbere mumashanyarazi ya colonoscopi.
Ishusho ityaye irinzwe na lens coatings irwanya micro-etching. Ikirangantego cya kure cyujuje ubuziranenge nubushyuhe bwa chimique isanzwe ya AER ikora. Nkigisubizo, pigiseli-urwego rusobanutse rugumaho igihe kirekire kuruta ibicuruzwa bisanzwe, bityo ibyiringiro byo kwisuzumisha mubikorwa bya colonoskopi bishyigikirwa mubuzima bwurwego.
Koresha geometrie no kugenzura ibiziga byumurongo byahinduwe binyuze mubushakashatsi bwubuvuzi. Hamwe n'umurongo woroshye wa torque hamwe no gushiramo insimburangingo itunganijwe neza, cecal intubation irashobora kugerwaho nimbaraga nke. Uku gutezimbere gukundwa nabakoresha ibikoresho byinshi bya endoscopi kuko umunaniro wumukoresha ugabanuka mugihe cyurutonde rwumunsi wose kandi gukoresha ibikoresho neza birashyigikirwa.
Kugenzura ibizamini bya leakage hamwe no kurwanya insulasiyo bikorwa kuri buri gice kugirango byuzuze ibipimo byumutekano wamashanyarazi.
Umwirondoro hamwe numucyo wo guhuza imyirondoro yatanzwe kuburyo ibyuma bya sisitemu ya endoscope ihari irashobora gukoreshwa nta guhagarika akazi.
IFUs isobanura ibipimo byemewe bya AER bityo gusubiramo kubahiriza byoroshe kumatsinda yibitaro.
Ikizamini cyateguwe kugirango kigaragaze ibibazo byukuri byubuvuzi. Kurenga ibikoresho byibanze bya colonoskopi, kugenzura kwagutse birakoreshwa kugirango ibikoresho bya endoskopi yubuvuzi bitwara neza iyo bihuye no kwambara bisanzwe.
Gukomeza isi ikingira hamwe nuburinganire bwuruzitiro birasuzumwa kugirango ibyago byumutekano wibyumba bigabanuke bigabanuke.
Kurwanya insulasiyo bipimwa nubushuhe kugirango hamenyekane inenge zitagaragara mbere yuko ibikoresho bigera mubitaro.
Ibizamini bya electromagnetic bihuza byanditse kugirango wirinde kwivanga nibindi bikoresho byo kubaga.
Intego zo gukemura, gusiba MTF, hamwe no kugenzura amabara bikoreshwa muguhindura buri endoskopi ya videwo mbere yo koherezwa.
Lens alignment jigs ikoreshwa kuburyo intera ya kure iguma muri microne, kugabanya vignetting hamwe nubworoherane bwuruhande.
Kuringaniza kwera gusubiza hamwe na gamma umurongo bigenzurwa kugirango ibimenyetso bisuzumwe bihuze ibice.
Kwipimisha kwihangana kwa articulation bigereranya amezi yo kunama kwa clinique, bityo kinks hamwe no kuvunika guhuza kumenyekana hakiri kare.
Umuyoboro wa patenti ugenzurwa na kalibibasi; kuvomera no guswera ibipimo byapimwe kandi byandikwa kuri sisitemu ya colonoskopi.
Ikarita ya Torque-to-deflection ibitswe hamwe numero yuruhererekane kugirango ishyigikire serivisi neza.
Ibizamini byo kunyeganyega no guta bikorerwa kubikoresho bipakiye kugirango wirinde gutsindwa biterwa no gutwara.
Ikirangantego cyikirere cyemeza ububiko bwubushyuhe hejuru yubushyuhe nubushuhe bukabije.
Ibikoresho byo gupakira byakozwe muburyo bwo kurinda optique ya kure mugihe imyanda iba mike.
Imiti myinshi ya AER yerekana imiti igereranwa kugirango kashe, ibifatika, hamwe na polymers biguma bihamye mugihe runaka.
Imiyoboro ya biopsy irwanya igenzurwa hamwe nibikoresho bisanzwe byinjizwamo.
Ingufu zo hejuru hamwe na micro-roughness bigenzurwa kugirango tunoze neza kandi bigabanye ingaruka za biofilm.
Ubushobozi bunini bwubatswe kuburyo amasoko manini ashobora gutangwa mugihe ubuziranenge bwabitswe. Ingirabuzimafatizo zakozwe kugirango zigabanye igice kimwe aho gukurikiranwa bibitswe kurwego rwibice. Abakora ibikoresho bya Endoscopi bakunze guhura nibihinduka hejuru; mugutondekanya uruganda rwa XBX colonoscope mumurongo wa takt-iringaniye, ibyinjira byiyongera bitabangamiye imipaka yo kugenzura, kandi itandukaniro ryikurikiranya ryiziritse mubigufi.
Abatanga ibintu byingenzi kubikoresho byerekana amashusho, kumurika ibice, no kumenagura ibiti byombi biva mu rwego rwo kugabanya ingaruka.
Abatanga amanota hamwe nubugenzuzi bwigihe cyakoreshejwe kuburyo inenge zinjira ziguma hasi kandi zihamye.
Ikizamini cyo kwakirwa cyinshi gikubiyemo igenzura rinini, kugenzura kurangiza, hamwe no guhuza imiti.
Imibare ikurikirana ihujwe namakuru yikizamini, ikarita ya torque, hamwe nibisubizo bya kalibibasi. Hamwe nizi nyandiko, ibyifuzo byo kubungabunga birashobora gutangwa kubakiriya. Imigendekere yamakuru kandi ituma ibishushanyo mbonera bitandukanya XBX nibicuruzwa bisanzwe ku isoko kubisubizo byubuvuzi bwa endoskopi na sisitemu ya colonoskopi.
Ibipfunyika birinda byakozwe kugirango birinde guhungabana kure; inzitizi zubushuhe zemewe kubyoherezwa igihe kirekire.
IFU yanditswe kugirango isobanuke, bityo amakipe asubiramo arashobora kuzuza inzinguzingo zisabwa nta gukeka.
Ibyatsi bidakwiriye hamwe nibindi bikoresho byemewe byemewe, byongerera ubworoherane mumavuriro akoresha imvange yimikorere hamwe na endoskopi ikoreshwa.
Imbaraga za biopsy, imitego, ninshinge zo gutera inshinge zirageragezwa kugirango zishyamire hamwe nogukoresha binyuze mumikorere.
Inkomoko yumucyo hamwe nibitunganyirizwa byashizwe hamwe kugirango bigabanye igihe cyo kwishyira hamwe.
Ibikoresho bya serivisi hamwe na gahunda ya kalibibasi birasanzwe kuburyo ibigo byemewe bishobora kugarura imikorere yuruganda vuba.
Amatsinda yo gutanga ibitaro asuzuma ibirenze igiciro. Iyo agaciro kose gasuzumwe, ibyiza bya uruganda rwa XBX colonoscope biragaragara neza: igihe kinini, amashusho ahamye mugihe, serivisi zihuse, hamwe ninyandiko zorohereza kwemererwa. Mugihe ibicuruzwa bisanzwe bishobora kugaragara bisa kurupapuro rwihariye, ibiciro nyabyo-nyabyo bikunze gutandukana nyuma yamezi yo gukoresha no gusubiramo inshuro nyinshi.
Igiciro cya Colonoscope nigihe cyo kubaho:Ubuzima bwongerewe igihe cyo gutoranya ibikoresho no gutekesha kashe; kubwibyo, ikiguzi cyiza kuri buri nzira kiragabanuka.
Guhuza na sisitemu ya endoscope iriho:Gutunganya hamwe numucyo utanga imyirondoro iratangwa, kubwo kohereza birashobora gukomeza nta guhagarika akazi.
Amahugurwa no mu bwato:Abashinzwe amavuriro hamwe na modul ya videwo biratangwa, abakozi rero bagera kubumenyi vuba kandi neza.
Serivisi n'ibice:Inteko isanzwe hamwe namakarita ya torque yerekana gusuzuma no gusana byihuse.
Gahunda yo gusuzuma gahunda yunguka kumashusho ahoraho no kumera neza, bifasha kumenya polyp.
Ubuvuzi bwa colonoscopi bufashwa no kugenzura ergonomique no guteganya guhanura, bifasha mugukoresha neza ibikoresho.
Ibicuruzwa byinshi-byinjiza agaciro byagabanutse igihe cyateganijwe hamwe nigihe giteganijwe cya serivisi gishyigikiwe no kwinjiza amakuru.
Kuberako XBX ikora amadosiye yamateka akomeye kandi igahindura igenzura, imiryango yibicuruzwa irashobora kuzamurwa hamwe nuburyo bushya bwo kwerekana amashusho nta buryo bushya bwo guhungabana. Ibitaro byakira urubuga rugumaho hamwe niterambere mugutunganya no kumurika mugihe urinda ibikorwa byakazi hamwe nibikoresho byamahugurwa.
Uruganda rwa XBX colonoscope rwateguwe kuburyo busobanutse kurwego rwibigize bihinduka kwizerwa mubyumba bikoreramo. Muguhuza igenzura rikomeye ryinganda, igeragezwa ryuzuye, hamwe na serivisi ziteguye serivisi, ingaruka zisanzwe zijyanye nibicuruzwa bisanzwe - gutesha agaciro amashusho, gutondeka neza, hamwe nigihe cyo gutungurana - bigabanywa. Kubitaro nababikwirakwiza bashaka ibikoresho bya colonoskopi byizewe hamwe nabafatanyabikorwa ba endoscope yubuvuzi bipima, uruganda rwa XBX colonoscope rwakozwe kugirango rutange ubuziranenge burambye.
XBX colonoscopes ikorerwa munsi ya ISO 13485 hamwe na sisitemu ya FDA yubahiriza ibisobanuro byuzuye kuri buri gice. Urwego rwose rukora optique ya kalibrasi, igeragezwa ryerekana, hamwe no kugenzura biocompatibilité. Ibi bivamo guhuzagurika cyane, kuramba, no gufata amashusho ahamye kuruta moderi ya colonoscope.
Buri cyiciro cy'umusaruro gikurikiranwa muburyo bwa digitale - kuva kugenzura ibikoresho fatizo kugeza guhuza optique. Igenzura ryikora ryikora (AOI), ikarita ya mape, hamwe nigeragezwa ryumuvuduko ukoreshwa kugirango buri cyiciro cyujuje umutekano w’ibitaro n’ibipimo ngenderwaho.
Yego. XBX colonoscopes yagenewe kwishyira hamwe hamwe na sisitemu ya endoskopi ihari hamwe nabatunganya amashusho. Imigaragarire yimbere hamwe na protocole ihuza byanditse kugirango bigabanye igihe cyo kwishyiriraho no kwemeza guhuza kwa muganga.
Ibitaro byungukirwa nubuzima burebure bwibikoresho, imikorere yimashusho ihamye nyuma yo gusubiramo inshuro nyinshi, inzinguzingo ngufi zo gusana, hamwe nibyangombwa bya tekiniki byubugenzuzi. Izi nyungu zigabanya ibiciro bya nyirubwite kandi bitezimbere uburyo bwizewe.
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