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I-
XC Medico yi-
ISO 13485:
umenzi oqinisekisiweyo we-2016. Izixhobo zethu zokulungiswa kwangaphandle zibambe isatifikethi se-CE kwaye zibhaliswe ne-FDA (iKlasi I / II) apho kuyimfuneko. Nceda ucele iqela lethu amaxwebhu esatifikethi esithile.
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A
Ngokubanzi, iiseti zethu zangaphandle zokulungisa kunye nezixhobo zibonelelwa
ngokungenantsholongwane
kwaye kufuneka zicolwe sisibhedlele (i-autoclave) phambi kokusetyenziswa. Nangona kunjalo, iinketho zokupakisha ezinyumba ziyafumaneka xa ziceliwe kwii-odolo ezithile.
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A
Ewe, iModyuli yethu
yaNgaphandle yokuLungisa iNkqubo
yenzelwe ukuhambelana kwendalo yonke engqondweni. Iintonga zethu zokuqhagamshela kunye neeclamps zihlala zisetyenziswa ngokutshintshanayo kunye neenkqubo eziqhelekileyo zamazwe ngamazwe, ezinikezela ukuguquguquka koogqirha.
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A
Iinkqubo zethu ziveliswa kusetyenziswa i-Medical-grade
Titanium Alloy
,
Stainless Steel , kunye ne-
ephezulu
Carbon Fiber
(ye-radiolucent rods yokudibanisa). Zonke izixhobo ziyahambelana ne-biocompatible kwaye ziyahlangabezana nemigangatho ye-ISO.
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A
Nceda uqhagamshelane neqela lethu lezentengiso usebenzisa le fomu ingezantsi okanye kuWhatsApp. Ukufumana isicatshulwa esichanekileyo, nceda ucacise iCandelo
leMveliso
(umzekelo, Ilizarov, i-Monolateral),
i-Material preference
(i-Titanium / SS / i-Carbon Fiber), kunye
noBuninzi
. Sidla ngokuphendula kwiiyure ezingama-24.
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A
Ukuxhasa amaqabane amatsha, sinikezela nge-MOQ eguquguqukayo. Unokwenza iodolo
ephantsi njengeseti enye
(ibhokisi yesixhobo + ukufakwa) ukuqala. Sizimisele ukukhula kunye nabasasazi bethu.
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A
Ngezinto eziqhelekileyo zesitokhwe (umzekelo, iifreyimu zeMono-lateral, izikrufu ze-Schanz), sizithumela ngenqanawa
kwiiyure ezingama-72
. Iiodolo ezilungiselelweyo okanye imveliso ye-OEM enkulu, ixesha lokukhokela lidla ngokuba
ziintsuku ezili-15
. Ixesha lokuhamba kwehlabathi liyahluka (iintsuku ze-7-15 zoshishino) ngokusekelwe kwiinketho zokuthutha emoyeni / elwandle.
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A
Ngokupheleleyo. Sikhuthaza abasasazi ukuba bacele
iikiti zeesampulu
ukuvavanya umgangatho wethu wezinto eziphathekayo kunye neendlela zokutshixa. Ukulungiswa kwesampulu ngokuqhelekileyo kuthatha
iintsuku ezi-3-5
ngokuxhomekeke kwiinkcukacha (umz., i-Titanium okanye i-Carbon Fiber components).
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A
Ewe, sisebenza ngokukhethekileyo
kwizisombululo ze-OEM/ODM
. Sinokwenza ngokwezifiso izilungisi zangaphandle ngokweemfuno zakho zeklinikhi, kubandakanywa
iileyibhile zangasese (ukumakishwa kwe-laser)
, ulungelelwaniso lwekhithi yesixhobo esiqhelekileyo, kunye noyilo lokupakisha ukuze ulungele iimfuno zakho zemarike yendawo.
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Umgangatho
yeyona nto iphambili kuthi. I-XC Medico ibonelela
ngewaranti yonyaka omnye
kuzo zonke iinkqubo zokulungisa zangaphandle ezigquma iziphene zokuvelisa kunye nokudinwa kwempahla. Sonke isilungisi kunye nesixhobo esisetiyo sivavanywa ngokuqatha kwi-100% kwilebhu yethu yoomatshini ngaphambi kokuthunyelwa.
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I
-XC Medico isebenza phantsi kwenkqubo engqongqo yolawulo lomgangatho wonyango. Siyi
-ISO 13485 eqinisekisiweyo
, kwaye iimveliso zethu zithobela i-CE kunye nemigangatho yolawulo yamazwe ngamazwe, iqinisekisa ukulandelwa kwe-100% kunye nokhuseleko.
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A
Ngokupheleleyo. Sinikezela ngeesethi ezipheleleyo, ezichanekileyo zotyando kuzo zonke iinkqubo zethu zomqolo (Open, MIS, Cervical, etc.). Izixhobo zethu ze-ergonomically zenzelwe ukuthuthuzela ugqirha kwaye zihambelana ngokupheleleyo nezifakelo zethu zokuqinisekisa iinkqubo ze-intraoperative ezigudileyo.
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A
Siyala ukuyekelela kumgangatho. Ufakelo lwethu lwe-titanium lwenziwa kwiprimiyamu ye-
Ti6Al4V ELI (iBanga lama-23)
efunyenwe kubaboneleli behlabathi abathembekileyo. Iikheji zethu ze-PEEK zisebenzisa izinto eziqinisekisiweyo (umzekelo, ukusuka kwi-Invibio okanye kwimithombo yenqanaba lezonyango elilinganayo), iqinisekisa ukuhambelana kwebhayoloji kunye namandla oomatshini anokuthelekiswa neempawu eziphezulu zamazwe ngamazwe.
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A
Kwizinto ezisesitokhweni, sinokuthumela kwiintsuku
ze-3-7
ngenxa yolawulo lwethu olululo lwempahla (kunye nokukhethwa kwendawo yokugcina impahla). Ngee-odolo zokwenziwa ngokwezifiso okanye umthamo omkhulu, ixesha lokukhokela eliqhelekileyo lihlala iiveki ezi-2-4, ngokukhawuleza kakhulu kunomndilili weshishini.
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A
Sinikezela ngomgaqo-nkqubo we-MOQ oguquguqukayo ukuxhasa ukukhula kweshishini lakho. Kwiimveliso eziqhelekileyo, samkela iiodolo zolingo ezincinci. Kwiiodolo ze-OEM ezenzelwe wena, i-MOQ ithethathethwana ngokusekwe kububunzima, kodwa sizama ukuyigcina inobubele kuqaliso kunye nabasasazi abamiselweyo ngokufanayo.
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A
Ewe, sisebenza ngokukhethekileyo kwizisombululo ezibanzi ze-OEM/ODM. Sinikezela ngokumakishwa kwelaser kwilogo yakho, uyilo lokupakisha ngokwesiko, kwaye sinokuphuhlisa imibuliso yabucala esekwe kwimizobo ethile okanye iisampuli ukunceda ukwakha ibhrendi yakho.
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A Ukuqinisekisa ukhuseleko kunye nokuthotyelwa, ukufakelwa kwamayeza ezemidlalo kufuneka kuqinisekiswe ngemigangatho yamazwe ngamazwe njenge-FDA (USA), i-CE Mark (iYurophu), kunye ne-ISO 13485 (iinkqubo zokulawula umgangatho). Ezi ziqinisekiso zibonisa imvume yolawulo kunye nokuthembeka kwemveliso.
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OoGqirha bajonga izinto ezifana nohlobo lokwenzakala, inqanaba lomsebenzi wesigulane, umgangatho wamathambo, imathiriyeli yokufakelwa, kunye nendlela yotyando. Bahlala bexhomekeke kumava ekliniki kunye nophando lwangoku ukukhetha izixhobo ezifanelekileyo zokulungiswa kwe-ACL, i-meniscus, okanye ukulungiswa kwamagxa.
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I -arthroscopy engenelelayo kancinane yehlisa ukwenzakala kotyando, inciphisa ixesha lokuchacha, yehlisa umngcipheko wosulelo, kwaye ibonelele ngokubalaseleyo ngokudibeneyo. Kuye kwaba yindlela eqhelekileyo yokuxilonga kunye nokunyanga ukulimala okuhlangeneyo kwezemidlalo.
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Ushicilelo lwe-3D lwenza ukuba iprototyping ekhawulezileyo kunye nokwenza okuchanekileyo kokufakelwa kunye nezikhokelo zotyando. Ivumela iinkampani zamathambo ukuba zenze izixhobo ezikhethekileyo zesigulana, ukufanisa ukuhluka kwe-anatomical, kunye nokuvavanya ukusebenza kwe-biomechanical ngaphambi kokuveliswa.
