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I-
XC Medico ingumkhiqizi oqinisekisiwe we
-ISO 13485:2016
. Imishini yethu yokulungisa yangaphandle inesitifiketi se-CE futhi ibhaliswe ne-FDA (Ikilasi I/II) lapho kufanele khona. Sicela ucele ithimba lethu amadokhumenti esitifiketi esithile.
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A
Ngokuvamile, amasethi ethu okulungisa angaphandle namathuluzi anikezwa
ngendlela engenanyumba
futhi kufanele abulawe amagciwane esibhedlela (i-autoclave) ngaphambi kokusetshenziswa. Kodwa-ke, izinketho zokupakisha eziyinyumba ziyatholakala uma zicelwa ama-oda athile.
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A
Yebo,
i-Modular External Fixation System yethu
yakhelwe kucatshangelwa ukuhambisana kwendawo yonke. Izinduku zethu zokuxhuma kanye nezinsimbi zivame ukusetshenziswa ngokushintshana nezinhlelo zamazwe ngamazwe ezivamile, ezinikeza ukuguquguquka kodokotela abahlinzayo.
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A
Amasistimu ethu akhiqizwa kusetshenziswa i-
Titanium Alloy
,
Stainless Steel yezinga lezokwelapha , kanye ne-
enamandla kakhulu
Carbon Fiber
(yezinduku zokuxhuma ezikhanyayo). Zonke izinto ezisetshenziswayo zihambisana ne-biocompatible futhi zihlangabezana namazinga e-ISO.
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A
Sicela uxhumane nethimba lethu labadayisi ngefomu elingezansi noma i-WhatsApp. Ukuze uthole ikhotheshini enembile, sicela ucacise
Uchungechunge Lomkhiqizo
(isb., Ilizarov, Monolateral),
Okuthandwayo
(Titanium/SS/Carbon Fiber), kanye
Nobuningi
. Ngokuvamile siphendula phakathi namahora angu-24.
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A
Ukuze sisekele ozakwethu abasha, sinikeza i-MOQ evumelana nezimo. Ungakwazi uku-oda
okuphansi njengesethi eyodwa
(ibhokisi lezinsimbi + izimila) ukuze uqale. Sizibophezele ekukhuleni nabasabalalisi bethu.
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A
Ngezinto zesitoko ezijwayelekile (isb., amafreyimu we-Mono-lateral, izikulufu ze-Schanz), sizithumela kungakapheli
amahora angama-72
. Kuma-oda enziwe ngokwezifiso noma ukukhiqizwa kwe-OEM enkulu, isikhathi sokuhola ngokuvamile siyizinsuku
eziyi-15
. Isikhathi sokuthutha emhlabeni wonke siyahlukahluka (izinsuku zebhizinisi ezingu-7-15) ngokusekelwe kuzinketho zempahla yomoya/yasolwandle.
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A
Impela. Sikhuthaza abasabalalisi ukuthi bacele
amakhithi amasampula
ukuze bahlole ikhwalithi yethu yezinto ezibonakalayo kanye nezindlela zokukhiya. Ukulungiswa kwesampula kuvame ukuthatha
izinsuku ezi-3-5
kuye ngezici (isb, i-Titanium noma izingxenye ze-Carbon Fiber).
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A
Yebo, sisebenza ngokukhethekile
kuzixazululo ze-OEM/ODM
. Singakwazi ukwenza ngokwezifiso izilungisi zangaphandle ngokuya ngezidingo zakho zomtholampilo, okuhlanganisa
ukulebula okuyimfihlo (ukumaka nge-laser)
, ukulungiselelwa kwekhithi yezinsimbi ngokwezifiso, kanye nomklamo wokupakisha ukuze uvumelane nezidingo zakho zemakethe yendawo.
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Ikhwalithi
yinto ehamba phambili yethu. I-XC Medico inikeza
iwaranti yonyaka ongu-1
kuwo wonke amasistimu okulungisa angaphandle amboza amaphutha okukhiqiza nokukhathala kwezinto ezibonakalayo. Yonke into elungiswayo kanye nesethi yezinsimbi ihlolwa ngokuqinile ngo-100% elabhorethri yethu yomakhenikha ngaphambi kokuthunyelwa.
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I-
XC Medico isebenza ngaphansi kwesistimu yokuphatha ikhwalithi yezinga lezokwelapha eqinile. Sigunyaziwe
i-ISO 13485
, futhi imikhiqizo yethu ithobela i-CE kanye nezindinganiso ezinkulu zokulawula zamazwe ngamazwe, iqinisekisa ukulandeleka nokuphepha okungu-100%.
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A
Impela. Sinikeza amasethi amathuluzi okuhlinza aphelele, anembe kakhulu kuwo wonke amasistimu ethu omgogodla (Open, MIS, Cervical, njll.). Izinsimbi zethu zenzelwe i-ergonomically ukunethezeka kodokotela abahlinzayo futhi zihambisana ngokugcwele nezimila zethu zokuqinisekisa izinqubo ezibushelelezi ze-intraoperative.
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A
Siyenqaba ukuyekethisa ngekhwalithi. Izimila zethu ze-titanium zenziwe nge-premium
Ti6Al4V ELI (iBanga lesi-23)
ezithathwe kubahlinzeki abathembekile bomhlaba wonke. Amakheji ethu e-PEEK asebenzisa izinto eziqinisekisiwe (isb, ezivela ku-Invibio noma emithonjeni yezinga lezokwelapha elilinganayo), ukuqinisekisa ukuhambisana kwezinto eziphilayo namandla emishini aqhathaniswa nemikhiqizo yamazwe ngamazwe aphezulu.
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A
Ngezinto ezisesitokweni, singathumela zingakapheli
izinsuku ezingu-3-7
ngenxa yokuphatha kwethu kahle uhlu lwempahla (kanye nezinketho zendawo yokugcina impahla). Kuma-oda okukhiqiza enziwe ngokwezifiso noma evolumu enkulu, isikhathi sokuhola esijwayelekile ngokuvamile singamaviki angu-2-4, ngokushesha kakhulu kunesilinganiso somkhakha.
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A
Sinikeza inqubomgomo ye-MOQ evumelana nezimo ukuze sisekele ukukhula kwebhizinisi lakho. Ngemikhiqizo ejwayelekile, samukela ama-oda amancane esilingo. Kuma-oda e-OEM enziwe ngokwezifiso, i-MOQ kuxoxiswana ngayo ngokusekelwe ebunzimeni, kodwa silwela ukuyigcina ifanele ukuqalisa kanye nabasabalalisi abamisiwe ngokufanayo.
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A
Yebo, sisebenza ngokukhethekile ekuxazululeni okuphelele kwe-OEM/ODM. Sinikezela ngokumaka nge-laser kulogo yakho, idizayini yokupakisha yangokwezifiso, futhi singathuthukisa nokubumba okuyimfihlo okusekelwe emidwebeni yakho ethile noma amasampula ukusiza ukwakha umkhiqizo wakho.
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A Ukuze kuqinisekiswe ukuphepha nokuhambisana, izimila zemithi yezemidlalo kufanele zigunyazwe ngezindinganiso zamazwe ngamazwe njenge-FDA (USA), i-CE Mark (i-Europe), ne-ISO 13485 (izinhlelo zokuphatha ikhwalithi). Lezi zitifiketi zibonisa ukugunyazwa ngokomthetho nokuthembeka komkhiqizo.
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Odokotela abahlinzayo bacabangela izici ezifana nohlobo lokulimala, ileveli yomsebenzi wesiguli, ikhwalithi yamathambo, izinto zokufakelwa, nendlela yokuhlinzwa. Ngokuvamile bathembele kokuhlangenwe nakho komtholampilo kanye nocwaningo lwamanje ukuze bakhethe amathuluzi okulungisa alungile e-ACL, i-meniscus, noma ukulungisa amahlombe.
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I -arthroscopy ehlasela kancane inciphisa ukuhlukumezeka kokuhlinzwa, ifinyeze isikhathi sokululama, yehlisa ubungozi bokutheleleka, futhi inikeza ukubonakala okuhle kakhulu ngokuhlanganyela. Sekuyiyona ndlela ejwayelekile yokuxilonga nokwelapha ukulimala kwamalunga okuhlobene nezemidlalo.
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Ukuphrinta kwe-3D kuvumela ukwenziwa kwe-prototyping okusheshayo nokwenza ngokwezifiso okunembayo kwezimila neziqondiso zokuhlinza. Ivumela izinkampani zamathambo ukuthi zenze amathuluzi aqondene nesiguli, ukufanisa ukuhlukahluka kwe-anatomical, nokuhlola ukusebenza kwe-biomechanical ngaphambi kokukhiqiza.
