Ukugqibezela Kwezinhlelo Zokwenza Iziphathimandla Ezihlukahlukene Ezenziwa Ngempilo KweOrthopedic Surgery
Umgwaqo wempilo wesilonda se inkampani yokwenza izixhobo zegazi elijulileyo ungaba yindawo ebalulekile kumnotho wasezintsheni yesilonda ngamanje. Lezi zixhobo ezihlelekile zisusa umphaphu wemiphakathi engcono yezinyalo, kepha izimo zokwakha kuzo kumele kube yinto enobulungiswa obukhulu. Ngelixa ukwenza teknoloji yezempilo, izidingo zokuba khona ubunzima, ubuncinane, nokuthembekileyo kumathuba okwelashwa kususela kakhulu, ekhuthaza abakhi uzame ukugcina izimo ezihle ngelishwa baze bathutha kwimithetho yabo.
Umlando wokwenza izixhobo zomdla wentsimbi yekini kuyaphucula kakhulu ngeminyaka engama-10 eyadlulayo. Ngoku, izixhobo ze-knee abasebenzi bokwenza izixhobo kufuneka bahlale emva kwimithetho enzima ngelishwa benza izinto ezingumthetho wabantu abahlinzekiyo bezolwandle. Uhluko oluhlelekile phakathi komdla, ukuthembekisa, nokwenza okuphelele kuchaza indlela yoktoday' ekugcineni izixhobo ezihlaziywa.
Izimiso Nezindlela Zokukhula
Ukukhetha Nomvavanyo Wezinto
Ngaphakathi kwiservice yokwenza izixhobo zokuphatha ikhanda kukho indlela ebalulekileyo yokukhetha izinto. Istenilesi esihlengalenga, njenge-316L okanye iingcobo ze-420, isebenza njengeyona into ephambili ngoba yenziwe ngendalo inobuthwalwa, inesivuno ekulungiseleleni kwaye inobulungiswa ngokumgangala. Le zinto zibizwa ngemithetho enjalo yonke kwaye ziyingcinwa ziya kwiindaba ezifanayo ukuqinisekisa ukuba ziyafumanisa iistandela zezixhobo zomthwalo ngezono.
Iindlebe ezinezilingo ezahlukeneyo zikwenzela uhlelo olupheleleyo lokulandelela izinto, elibhalisa yonke indawo yesimilo sokubhala kusuka kutholiwe kuya kumsebenzi wokugcina. Lokhu kuhlola kakhulu ubunzima bezinto kuyisahluko esibalulekileyo ekwenzeni izixhobo zokuphatha ezingazange ziphucule emva kokuchithwa ngokuphindaphindiwe ngelishwa kwaye ziqinisekise ukuba zizalwa ngamandla nezifundo.
Ukusebenza Ngokuphumula kunye nokuziphindezela Ukusuka
Abasebenzi besimiso sezinja zomzimba baphatha izikhungo ze-CNC ezintsha kakhulu nezinhlelo eziphucileyo ze-CAD/CAM ukufinyelela emandleni ephelele yesisindo. Kusenzelwa ngalunye ulwimi ngezidingo eziphathelene, okwaziwa ngokuthi kumamitha, ukuqinisekisa ukulayisha kahle nokusebenza kwizinja zomzimba.
Izinhlelo zokubonga ubomi ziqukethe izigaba eziningi zokuhlola, kuzo kufakwa ukubangela kwezidingo, ukuchaneka kweyafini, nokuphawula okusebenza. Izixhobo zokumelela ezinezimali, njengezixhobo zokumelela kwindawo (CMMs) nezinhlelo zokuhlola zokubuka, zibonakalisa ukuthi konke okuqukethwe kuyiphinde iphinde ibe yisimo esifanele ngaphambi kokudityaniswa.
Ukulingana Ngezimpendulo Nezincazelo
Amastandela Nezincoma Zezomibuso
Imisebenzi emihle yezinhlelo zokwakha izixhobo zokulawula isandla ezingenamkhawulo ihlala inemvume kwiindlela ezininzi zasezulwini, kubandakanywa i-ISO 13485 yezixhobo zokugcina ubomi nezidingo ze-FDA. Le mvume ibonisa ukuthembeka kumithetho yokuphatha ubugcisa okwenziwe ngokuchaza specifically kuzinhlelo zokwakha izixhobo zokugcina ubomi. Izahloli zokukhangela kanye nokuchazwa kuzenzelwa ukuqinisekisa ukuba kukhona ukuhlanganiswa okuqukethwe nale mithetho enjalo.
Izidingo zodokumenti kufana nezimangalo ezididi zokwakha, imvume yomthelela, imiphumo yokuchaza, kanye nezibalo zokuvavanya. Le ndlela ephambili yodokumenti iyameleka ukufinyelela kwayo kanye nokuxhasa ukulinganiswa kwezimali, njengoko kunikeza idatha ebalulekileyo ekusizeni ukuthuthuka okuqukethwe.
Amathuluzi asebenzela Ukuvavanya kanye Neqiniso
Inqolobane yonke yokwenza izixhobo kufuneka ibe nezimvo zokuthembeka eziphambili ezifakelwe kumsebenzi nokuthengiso. Lezi zimvo ziyeza kwiqondo le-Installation Qualification (IQ), Operational Qualification (OQ), kunye ne-Performance Qualification (PQ) kuzo zonke iimeko ezibalulekileyo neemisebenzi. Iinkcukacha ezimisweyo nazo zingcinwa ziya kugcinwa ubume obuphathekayo nobulungisa.
Ukubalisa okuthengiso kuhlanganisa ukuchazwa ngaphezu kwezimo ezihlalihlayo, ukuqinisekisa ukuba iixhobo zisebenza njengoko zithethile phantsi kwinkqubo yabo esemthethweni. Lokhu kuhlanganisa ukucinga izinto ezifana nokukhuseleka kwekhuba, ukukhuseleka kwe-corrosion, kunye nokugcina kwezilinganiso ezibalulekile emva kokususwa kakhulu.
Izindlela Ezikhoyo Zokusebenza
Ukuzenzekaliswa nokwenza izinto ngendlela ethintela
Ukuthunyelwa kwezinhlelo zomsebenzi futhi nezobuchwepheshe zokwakha izixhumanisi zamazinyo zibuyekeza amandla okwenza. Izinhlelo zokuphatha ngendiza, izikhungo zokuhlola ngendlela eyisiseko, nokulandelana kwemfundo yezokwelashwa kuyaphatha ubukhona bokwenza kodwa kubuyisela ubumfanganyiso obugcwele.
Iziprinciphi ze-Industry 4.0 zifikelelwa ngokwengeziwe, zifaka ukubeka isimo ngexesha elithile, ukulungisa ngaphambi kokuthinta, nokuzinza izinkcazo ukuze kube lula ukwenza. Lezi zizobuchwepheshe ezihleli zikwenzela abakhiwa ukufinyelela ubukhona, ubumfanganyiso obuhle, nokuthuthuka kahle kwezinyathelo zabo.
Ukunciphisa Futhi Ukugcina
Izobuchwepheshe ezahlukene zokunciphisa okuphezulu ziduma inkathi ekubeni yakhaza iphephandaba nempilo yezixhumanisi zokushisa. Izindlela ezithile zokufaka amakhimikhali, ukucindezela, nokulungisa ukuncipha kwenza ukuthulaselwa kwebhuruku kungcono futhi kwenza amakhanda akhethekile ekuqashini kwezixhumanisi zokushisa.
Abasebenzi basebanga okwenza izixhobo zokuphefumula kusihlangothi bakhokhela izinkululeko ezivamile ezingcono ekugcineni izixhobo, okwenzekelayo ukunakekela umsebenzi wazo nokunciphisa inkathalo yokucindezela ngokubanzi emshini. Lezi zindlela zikusiza ekukhokheni ukuthi kungahlali ibhayosifilm futhi kunciphe inkinga yokucindezelana emshini.
Imibuzo Evame Ukubuzwa
Kufanele kube nani amakhobho abe ngumsebenzi wokwenza izixhobo zokuphefumula kusihlangothi?
Umsebenzi ongcolileyo wokwenza izixhobo zokuphefumula kusihlangothi kufanele akhokele amakhobho ka-ISO 13485 ekwenzeni izixhobo zomdlalo, futhi akhokele i-FDA uma uphatha emazweni ase-US, futhi akhokhe izinhloso zemibuso njenge-EU MDR emazweni ase-Europe. Amakhobho angcono okulinganisa igugu njengoko ISO 9001 angakwazi ukuqinisekisa ukholo kumsebenzi wokwenza.
Izikhathi ezimangalisayo ziziphi izixhobo zokuphefumula kumele zihlaziywe?
Ukuhlolwa kakhulu kusenziwa emaphazakeni amaningi ngempuma yendawo yokwakha, kufaka phakathi ukulondoloza kwezinto ezavela, ukulunga okuphakathi, nokubonisa izimpahla ekugcineni. Isandla sonke sokusebenza kuyaphindwa kabili ukulondoloza izikhathi ezibalulekile kanye nesimo sakhe ngaphambi kokuthuliwa, ngokuphindaphindiwa kwezigaba zokuhlola izici eziningi.
Iziphi izinto eziphiliphameni kuzo izixhumanisi zezenzo yekini?
Izixhumanisi zezeshono ezinezigaba ezithile zisakaziswa ngendilinga enkulu yesiliva esihlanjiwe, ikakhulu i-316L noma i-420, ngoba yenziwa ngokukhanya kwe-corrosion, ubumnene, nokwaziwa kuthutha. Lezi zinto kumele zilondoloze izigaba ezithile zomlando weshono futhi zilungelwe ukulondoloza ngokuhlanganisa nokusebenza.
