Igisubizo cyihuse
Isahani ya radiyo ya kure niyimbere yo gukosora ikoreshwa muburyo bwatoranijwe bwa radiyo yamenetse. Abaguzi bakunze kugereranya ibyapa bifunga volar, ibishushanyo mbonera bidafunze, ibyapa bya dorsal hamwe na sisitemu yihariye igurishwa ku mazina nka DVR. Ibirango ntibishobora guhinduka: izina rya DVR ni sisitemu cyangwa izina ryibicuruzwa, mugihe volar na dorsal bisobanura umwanya wa plaque. Mbere yo kugereranya ibyatanzwe, huza umuryango ugenewe isahani hamwe nibisabwa bikenewe kuvunika, kuruhande, uburebure bwa plaque hamwe nu mwobo, amahitamo ya screw, ibikoresho, ibimenyetso hamwe nuburenganzira bwaho. Umutego wigiciro urimo kugereranya ikintu cyashizwe kumurongo gusa hamwe na sisitemu yuzuye: inzira, ibikoresho, kuzuza, kwerekana sterile, inyandiko hamwe no guhuza bishobora guhindura agaciro gakoreshwa.
Muri Aka gatabo
- Icyo icyiciro cyatewe gikubiyemo
- Imiryango ine
- Ibibazo bya Volar cyangwa dorsal
- AO / OTA gutondekanya no kubara
- Igikoresho-cyuzuye cyuzuye
- Gusoma urupapuro rwabigenewe
- Kugereranya amagambo yatanzwe
- Amakosa atanu yo gushakisha
- Ibibazo byo kohereza uwaguhaye isoko
- Ibibazo bikunze kubazwa
- Intambwe ikurikira
- Inkomoko no kuvugurura inyandiko
1. Isahani ya radiyo ya kure ni iki - kandi ni ryari Iyerekana Ihindura Implant?
Iradiyo ya kure nigice cyamaboko-impera ya radiyo. Isahani ya radiyo ya kure ni isahani yamagufa yagenewe gushyigikira gukosora imvune zatoranijwe cyangwa osteotomies zirimo kariya karere. Isahani ni kimwe mubice byubaka bishobora no kuba birimo gufunga cyangwa kudafunga imigozi, insinga ziyobora, imyitozo, ibipimo byimbitse nibikoresho byabigenewe. Sisitemu nyayo igenewe gukoreshwa no kuboneza biva mubuyobozi bwayo bwo gukoresha (IFU), kuranga ibicuruzwa no kwemerera isoko.
Kubakwirakwiza, 'isahani ya radiyo ya kure ' nicyiciro cyagutse, ntabwo SKU imwe ihinduranya. Inshingano irashobora gushiramo plaque plaque, plaque dorsal, rim cyangwa inkingi yihariye, ibishushanyo byibumoso-iburyo, hamwe nuburebure butandukanye cyangwa umwobo. Kurugero, urutonde rwa XC Medico umwobo, imyobo irindwi na DVR-yuburyo bwa radiyo isahani yibicuruzwa. Izi ni kataloge ingero, ntabwo ari icyifuzo cyo kubika ingano runaka cyangwa ikirego kivuga ko ibishushanyo bisimburana.
Kwerekana bihindura ibiganiro byibicuruzwa kubera ko kuvunika, imiterere yibice, ubwiza bwamagufwa, gukomeretsa bifitanye isano nubwubatsi bwabaganga bateganya bigira ingaruka kuri plate geometrie na trayektori. Umuganga abaga agena ubuvuzi. Isoko ryo gushakisha rishobora gufasha kwemeza ko ikintu cyasabwe, ibikoresho ninyandiko bihuye na sisitemu yatoranijwe; ntishobora guhitamo kuvunika bigomba gushyirwaho. Uwiteka intera ya radiyo yamenetse yo gukosora isobanura uburyo bwagutse bwo gukosora. Kuburyo bujyanye no gukosora, reba ubuyobozi kuri intera ya radiyo yamenetse K-wire ikosora.
2. Abaguzi bane ba radiyo isahani Imiryango Abaguzi Mubisanzwe Mugereranya
Ibi byiciro bifasha gukora urutonde rwibicuruzwa; ntabwo ari tagisi yisi yose kandi irashobora guhuzagurika. Igicuruzwa cyanditseho DVR ubwacyo gishobora kuba plaque. Baza uwaguhaye isoko gushushanya buri zina ryamamaza kuri moderi nyayo, ubwubatsi, imiyoboro ijyanye na IFU y'ubu. Kwita ibicuruzwa rusange birashobora kandi gutandukana kumasoko no gusubiramo kataloge.
| Umuryango cyangwa ikirango | Icyo ijambo risanzwe ryerekana | kugenzura amasoko | Ntugatekereze |
|---|---|---|---|
| Isahani yo gufunga | Yashizweho kugirango volar ishyirwe, hamwe no gufunga umwobo nkuko byavuzwe. Amahitamo ahamye- cyangwa impinduka-inguni biterwa na sisitemu. | Ibirimo, uruhande, umwobo, imiyoboro ihuje, inzira zemewe, kuyobora hamwe nabashoferi. | Ko buri plaque ya volar ihindagurika-inguni cyangwa ihuye nuburyo bwose bwo kuvunika. |
| Volar idafunze isahani cyangwa kubaka | Igishushanyo cya volar ukoresheje imigozi idafunze, cyangwa isahani ivanze hamwe nu mwobo watoranijwe udafunze. | Ubwoko bwa Hole, moderi ya screw, ibiranga compression, umushoferi na IFU y'ubu. | Iyo miyoboro yo gufunga no kudafunga irashobora guhanahana umwobo uwo ariwo wose. |
| Isahani | Byagenewe gushyirwaho dorsal; amahitamo arashobora gushiramo rim, inkingi cyangwa ibishushanyo mbonera. | Subfamily, kontour, uruhande, screw trayectory, ibikoresho na label. | Ko isahani ya dorsal isubizwa inyuma ya volar plate cyangwa ko ibishushanyo mbonera bisimburana. |
| Sisitemu yitwa DVR | Igicuruzwa cyangwa izina rya sisitemu ikoreshwa mugutandukanya intera ya volar radius; ntabwo ari tekiniki rusange. | Uruganda rwemewe, icyitegererezo nyacyo, guhuza imashini nibikoresho, izina ryaho no kwiyandikisha. | Ko buri bicuruzwa byitwa DVR bisangiye geometrie, ibikoresho cyangwa imiterere yubuyobozi. |
Itandukaniro ni ingirakamaro. Inshingano zerekana urutonde rumwe 'intera ya radiyo ifunga isahani ' irashobora cyangwa ntishobora gushyiramo dorsal, rim, radial-inkingi cyangwa hagati-inkingi. Urutonde rwa XC Medico rugaragaza ukundi kuruhande, inkingi, Hagati-Inkingi, icyuma gifunga isahani kandi volar nyinshi-axial ifunga isahani. Umuguzi agomba kwemeza niba itangwa ari isahani itandukanye, ibikoresho bya platifomu, cyangwa urupapuro rwumurage rwasimbuwe.
Ibikoresho bisaba kandi ibimuranga neza. 'Titanium ' yonyine ntabwo yuzuye: saba ibinure cyangwa urwego, ibisabwa bisanzwe kandi bifitanye isano nibintu bifatika. Ti-6Al-4V ELI na ASTM F136 nibiranga byihariye rimwe na rimwe bikoreshwa mubitabo byatewe; ntukibwire ko isahani ya titanium iyikoresha.
3. Volar cyangwa Dorsal? Nibihe bibazo bigomba gushiraho urutonde rwibicuruzwa?
Abaterankunga bahuza sisitemu yasabwe kwa muganga watoranijwe wubatswe hamwe na label yaho, hanyuma uhindure ibisabwa mubintu bya kataloge nibikoresho.
Ikibazo cya mbere: ni akahe karere ka anatomiki hamwe no gukwirakwiza ibice bisabwa?
Baza niba icyifuzo ari icyapa rusange cya volar, igishushanyo mbonera cya volar, isahani ya dorsal, cyangwa radial- cyangwa hagati-inkingi. AO Surgery Reference isobanura uburyo bwo kuvunika bwa dorsal kugirango isahani ya dorsal ishobora gukoreshwa mubuhanga bwerekanwe, ariko ibi nibisobanuro byihariye bivunika, ntabwo ari itegeko rusange. Inyubako ikwiye iracyari icyemezo cyumuvuzi wujuje ibyangombwa. Igikorwa cyo gutanga amasoko nugukora ibishoboka byose kugirango umuryango wibisahani ubeho mugihe cyumushinga utanga isoko kandi ko ikirango cyacyo gikubiyemo gukoreshwa.
Ikibazo cya kabiri: ni ubuhe buryo n'ibikoresho umuryango umuryango w'amavuriro ukoresha?
Uburyo bwa Henry bwahinduwe nuburyo budasanzwe bwo kwerekana palmar / volar; ntabwo ari isahani yerekana cyangwa izina ryisi yose. Baza uburyo bwihariye bwa tekinike yubuyobozi, urutonde rwibikoresho hamwe nibisobanuro bihuye. Ntugasimbuze ibikoresho kuko inzira igaragara.
Ikibazo cya gatatu: ni izihe mbogamizi zihariye ku isoko?
Reba iyandikwa ryaho, ibimenyetso byemewe, imiterere itajenjetse, ibisabwa byururimi kandi niba impinduka zisabwa zigaragara kurutonde rwemewe. Igicuruzwa gishobora gusobanurwa kurubuga rwisi nyamara ntiruboneka cyangwa rwanditse muburyo butandukanye kumasoko runaka. Niba ibitaro bisaba 'isahani ya DVR, ' saba uwagusabye kumenya uwagikoze nicyitegererezo cyihariye cyangwa akemeza ko bivuze icyiciro rusange cya radiyo ya radiyo.
4. AO / OTA 23 Bisobanura iki kurutonde rwimigabane?
Kode ya AO / OTA isobanura aho yavunitse na morphologie. Umurage werekana umurage urashobora gukoresha '23 ' kuri radiyo ya kure. Muri compendium y'abakuze 2018, radiyo ya kure yanditseho 2R3 , hamwe na A, B na C mumatsinda adasanzwe, arigice-articular kandi yuzuye-arctular. Reba icyegeranyo cyemewe kumatsinda mato. Kode isobanura kuvunika; ntibategeka gushyirwaho cyangwa gutondekanya ingano.
| Ibyiciro byerekana | Ibyasobanuwe kurwego rwohejuru | Igenamigambi-Igenamigambi | risabwa kurinda |
|---|---|---|---|
| Umurage '23 ' / radiyo igice cya kure | Ikirango kimenyerewe mubikoresho bya kera bya AO / OTA, kwiga no kugura imvugo. | Ijambo ryambukiranya umurage ijambo ryibicuruzwa bigezweho hamwe na coding amagambo akoreshwa nabaganga babaga hamwe na rejisitiri. | Ntugashushanye kode yumurage kuri moderi imwe. |
| 2R3A - idasanzwe | Kuvunika mubice bya radiyo ya kure bitaguka hejuru yubuso, hamwe nandi matsinda mato ya morphologie. | Baza niba serivisi zaho zikeneye ibishushanyo mbonera bya volar, impande zinyuranye, hamwe nuburebure bwa shaft bihuye nurubanza rwavanze. | Icyiciro cyonyine ntabwo gishyiraho uburebure bwihariye bwa plaque, kubara umwobo cyangwa inzira ya screw. |
| 2R3B - igice cyihariye | Uruhare rwihariye hamwe nigice cyubuso buhuriweho busigaye bufatanye nigiti; amazina matsinda mato arimo ibice bitandukanye. | Ongera usabe ubufasha bwihariye bwihariye, harimo ibicuruzwa cyangwa inkingi yihariye mugihe itsinda ryamavuriro ribisabye. | Ntugashishoze isahani isabwa kuva kumurongo umwe witsinda; wemeze ibyifuzo byubuvuzi nibicuruzwa IFU. |
| 2R3C - byuzuye | Igicapo cyuzuye cyo kuvunika hamwe no gutandukanya imitsi ya arctular na shaft; matsinda asobanura morphologie yinyongera. | Muganire niba sisitemu yaho ikeneye guhitamo isahani yagutse hamwe nigikoresho cyuzuye cyo gushyigikira serivisi zatoranijwe. | Gutondekanya ntabwo bivura algorithm kandi ntibisimbuza igenamigambi ryihariye. |
Koresha ibyiciro nkikiraro cyamagambo, ntabwo kode-kuri-SKU ihinduka. Gereranya amateka yubuguzi bwaho hamwe nibitekerezo byubuvuzi hamwe na catalogi yanditse, hanyuma ikarita kuruhande, geometrie, umwobo, imigozi hamwe na tray iboneka. Emeza buri cyitegererezo mbere yo gutumiza. Kode irashobora gutegura ibiganiro-bivanze, ariko ntabwo ari ibiteganijwe.
5. Ni ubuhe buryo bwuzuye ibikoresho bya radiyo yuzuye bigomba kuba bikubiyemo?
Isahani yerekana gusa ntabwo ari sisitemu yuzuye. Ibikoresho bya radiyo ya kure bigomba gusubirwamo kurutonde rwabashinzwe gukora, tekinoroji ya tekinike hamwe na tray igaragara. Ibikoresho nyabyo biratandukana na sisitemu, isahani yumuryango hamwe nakazi kaho, urutonde rero hepfo ni igenzura ryuzuye - ntabwo rikurikirana cyangwa urutonde rusange ruteganijwe.
| Shiraho ibice | byumuguzi wo kugenzura | Ibimenyetso byo gusaba |
|---|---|---|
| Isahani yumuryango nibigeragezo cyangwa infashanyo yo guhagarara | Emeza icyitegererezo cya plaque n'ibumoso / iburyo byahinduwe; tandukanya ikigeragezo, inyandikorugero cyangwa imyanya ihagaze hamwe nuwatewe. | Inzira ya none igaragara hamwe namazina yibintu na numero ya catalog. |
| Kuyobora imyitozo n'amaboko | Reba guhuza nibyobo bya plaque hamwe na trayektori yemewe, harimo niba amahitamo-ahindagurika hamwe nimpinduka-mpande zikoresha inzira zitandukanye. | Igikoresho-kuri-gushiramo guhuza matrix hamwe nubuyobozi bwa tekinike. |
| Imyitozo no gupima ubujyakuzimu | Huza diameter nuburebure bwakazi kumuryango wa screw; genzura uburebure bwikigereranyo nuburyo utanga ibirango bipima. | Umubare wa Cataloge, ibipimo ngenderwaho n'amabwiriza yo kugenzura. |
| Abashoferi n'abashoferi | Emeza ibice bya drayike, uburebure bwumushoferi, kuyobora amahitamo nimba umushoferi yitangiye ibisekuru runaka. | Imbonerahamwe yo guhuza ibinyabiziga no gusimbuza-ibice biranga. |
| Kugabanya nibikoresho byo gutunganya by'agateganyo | Baza ibikoresho birimo, bidashoboka cyangwa hanze ya sisitemu ya plaque; kugenzura guhuza no gukoresha. | Urutonde-Ibintu-Urutonde, IFU nibisabwa byose kubicuruzwa bitandukanye. |
| Inzira, dosiye hamwe nibikoresho byo kuboneza urubyaro | Emeza ibipimo bya tray, ubushobozi, kubara ibikoresho, gufunga no gutwara ibintu; menya niba kontineri yemewe kubikorwa byavuzwe. | Imiterere ya tray, isuku hamwe na sterisizasiyo, hamwe nibimenyetso bifatika. |
| Serivisi ikoreshwa neza | Sobanura inshingano zo gusimbuza, gusana, kugenzura no kuzuza, harimo nuburyo ibikoresho byabuze cyangwa byangiritse byamenyekanye. | Amagambo ya serivisi yanditse, urutonde rwibice hamwe nuburyo bwo gukurikirana ibikoresho. |
Gereranya inzira igaragara kumurongo kumurongo hamwe na cote. 'Igice cyuzuye ' gishobora gusobanura inzira yuzuye, iboneza ritangira cyangwa igenamiterere ridafite ibikoresho byubushake. Emeza niba ibyatewe bitandukanijwe, ibikoresho bisubirwamo byatanzwe nuburyo ingano ihuye yamenyekanye.
Subiramo XC Medico ibikoresho bya radiyo ya kure byashizweho , mugari ibikoresho by'ihungabana , na uburyo bwo kubika ibintu . Emeza guhuza inzira, gusubiramo kataloge no gukora isuku / amabwiriza yo kuboneza urubyaro. Kubyiciro byegeranye, reba i radius na ulna urwego kandi ihahamuka rya sisitemu portfolio.
6. Abaguzi bakwiye gusoma bate urupapuro rwihariye mbere yo gusaba ingero?
Soma urupapuro rwihariye nkurutonde rwibicuruzwa bigenzurwa. Mbere yo gusaba icyitegererezo, huza ibisobanuro kurugero, gusubiramo, ibice bihuye nibiranga amabwiriza. Ubuyobozi bwa FDA 2024 butari umugongo bwerekana amakuru yihariye yibikoresho nkurubuga, ibikoresho, ibipimo hamwe na screw ihuza; ntisimbuza amategeko yisoko ryerekeza.
| Umwanya wihariye | Ibyo uwagabanije agomba kugenzura |
|---|---|
| Ibiranga ibicuruzwa | Uruganda rwemewe, izina ryubucuruzi, icyitegererezo / SKU, gusubiramo kataloge, umuryango wibicuruzwa niba ikintu cyashyizwe ku rutonde kiriho cyangwa cyasimbuwe. |
| Isahani ya geometrie | Volar / dorsal cyangwa inkingi / rim; ibumoso / iburyo; kubara umwobo n'ubwoko bw'umwobo; uburebure bwa plaque, ubugari n'ubugari; ibipimo byerekana ibipimo. |
| Ibikoresho no kurangiza | Gukora neza cyangwa urwego, ibikoresho bifatika nka ASTM F136 aho bisabwa, kuvura hejuru cyangwa gutwikira, hamwe nicyemezo gifatika. 'Titanium ' yonyine ntabwo ihagije kugereranya ibisobanuro. |
| Imigaragarire | Imiryango ibangikanye, diametero, uburebure, ubwoko bwumutwe / gutwara, ibikorwa byo gufunga cyangwa kudafunga, ibisobanuro bihamye cyangwa bihindagurika-bingana ibisobanuro hamwe ninzira yemewe yavuzwe nuwabikoze. |
| Guhuza ibikoresho | Kuyobora imyitozo, umwitozo, igipimo cyimbitse, umushoferi, tray hamwe numubare wibikoresho byabigenewe; gusubiramo no guhuza ibisekuruza. |
| Kwerekana neza | Imiterere ya sterile cyangwa idafite sterile, ikoreshwa rimwe cyangwa yongeye gukoreshwa, kugena ibipfunyika, uburyo bwo kuboneza urubyaro aho byatanzwe sterile, label na IFU guhuza. |
| Indangamuntu | Intego-kwandikisha isoko cyangwa kwerekana ibicuruzwa; uruganda rwemewe nuwuhagarariye / utumiza mu mahanga aho bishoboka; ingano y'ibicuruzwa no gukoresha. |
| Kugenzura inyandiko | Ibiriho IFU, ikirango, kataloge, ibyemezo byubuziranenge, incamake yikizamini n'amatariki yo gusubiramo; wemeze ko ibirango by'icyitegererezo hamwe n'inyandiko bihuye na SKU yavuzwe. |
Sobanura icyo icyitegererezo kigamije gushiraho: gusubiramo ibipimo, ibikoresho bikwiranye, gusubiramo ibicuruzwa cyangwa gusuzuma isoko. Icyitegererezo kitari sterile ntigishobora gushyiraho uburyo bwo gupakira ibintu, kandi kugenzura ntigushobora kwerekana imikorere yubukorikori cyangwa guhuza byinshi.
Koresha amagambo asobanutse yo gupima isahani, screw n'uburebure bw'akazi. Kuri sisitemu ihindagurika, saba urwego rwemewe kandi ushyigikire inyandiko tekinike. Huza icyitegererezo cyikirango nicyitegererezo kuri cote, IFU nibyemezo byaho. Niba indangamuntu zitandukanye, saba inyandiko yakosowe yashyizweho mbere yo gusuzuma.
7. Nigute ushobora kugereranya amagambo abiri yabatanga utagereranije bitandukanye nibitangwa?
Kugereranya amagambo bigomba gutandukanya ibyatewe, sisitemu y'imikorere nubusabane bwo gutanga. Umurongo muto urashobora guhisha ibikoresho byabuze, ibikoresho bidahenze, akazi kinyandiko cyangwa kuzuza kutizewe. Amagambo yagutse arashobora gushiramo ibintu umuguzi adakeneye. Koresha urwego rumwe rwanditse kuri buriwese utanga kandi ugereranye ibimenyetso kuruta gutekereza.
| Kugereranya inkingi | Ibibazo byo kubaza | ibimenyetso bituma itangwa rigereranywa |
|---|---|---|
| 1. Ingano y'ibicuruzwa kandi bikwiye | Imiryango imwe isahani, impande, uburebure, imiterere yumwobo, ubwoko bwa screw nibikoresho bihuye birimo? Amazina yibicuruzwa nimero yicyitegererezo nibyo? | Umurongo-ku-murongo SKU gahunda, guhuza matrix, kataloge y'ubu na IFU. Shyira akamenyetso ku bintu cyangwa ku bushake. |
| 2. Ibimenyetso bigenga kandi bifite ireme | Ese itangwa ririmo ibicuruzwa byemewe ku isoko ryerekeza? Ninde ukora ibicuruzwa byemewe n'amategeko? Impamyabumenyi ziriho kandi ziri murwego? | Kwiyandikisha cyangwa kwemeza ibimenyetso, igipimo cyicyemezo, ikirango / IFU kopi, icyemezo-cyiza cya sisitemu namakuru ahindura-kugenzura amakuru. |
| 3. Inkunga y'ibikorwa | Nigute ibikoresho bitangwa, bikurikiranwa, bisanwa kandi byuzuzwa? Ni ayahe mahugurwa, ubusemuzi, gukemura ibibazo hamwe n'inkunga ya tekiniki bikubiyemo? | Inzira igaragara, amagambo ya serivisi, yitiriwe inzira yo gushyigikira, politiki yo gusimbuza ibikoresho nibikoresho byamahugurwa byanditse. |
| 4. Igiciro cyubuzima bwose hamwe ningaruka zo gutanga | Ni ibihe biciro bisubirwamo, ibyemezo byimigabane, imbogamizi zo gupakira, amagambo yo gutwara ibintu, ibice bisimburwa cyangwa ibicuruzwa byagaragaye hanze ya cote? | Ibitekerezo byanditse byubucuruzi, kuzuza no guteganya amagambo, garanti / kugaruka, ibisobanuro birambuye hamwe nimpapuro zishingiye ku rupapuro rwuzuye. |
Saba igitebo kimwe cya buriwese utanga isoko: amazina yamasahani, imiyoboro ihuje, ibikoresho, kwerekana sterile, inyandiko, gupakira hamwe nuburyo bwo gutanga. Komeza guhezwa kugaragara kandi usobanure niba inzira yongeye gukoreshwa igurishwa, kugurizwa cyangwa gutangwa mubundi buryo.
Shyiramo ibarura, kwiyandikisha, gutumiza mu mahanga, gutunganya inzira, amahugurwa n'ibikoresho byo hasi mugihe cyose. Kuburyo bwuzuye, reba burya abadandaza bashobora gusuzuma ibiciro byabatanga ibicuruzwa birenze urutonde rwambere ; kugereranya amagambo, soma nigute wagereranya orthopedic yatewe OEM.
Gereranya ibyanditse byuzuzanya hamwe ninshingano za serivisi, ukoresheje icyerekezo kimwe-isoko yibitekerezo byo kuranga, kwinjiza no kugenzura. Kuri OEM / Private-label itangwa, sobanura tekiniki-inyandiko hamwe ninshingano zo kugenzura.
8. Amakosa atanu Abaguzi bakora iyo bashakisha amasahani ya radiyo ya kure
- Ugereranije nijambo ryibanze aho kwerekana icyitegererezo. 'DVR, ' 'icyapa cya volar ' na 'icyuma cya radiyo gifunga icyapa ' gishobora kwerekeza kubiranga ibicuruzwa bitandukanye. Baza uwakoze byemewe n'amategeko, SKU nyayo, ivugurura rya kataloge na IFU.
- Dufashe ko diameter nominal screw yerekana guhuza. Ifishi yumutwe, umutwe wimbere, uburyo bwo gufunga, uburebure, umushoferi hamwe ninzira yemewe byose. Saba uruganda rwatanze urutonde rwihuza.
- Kugura ibyatewe nta gahunda y'ibikoresho. Isahani ntishobora gukoreshwa mubikorwa byateganijwe idafite umurongo uhuza, imyitozo, ibipimo, abashoferi na tray. Ongera usuzume gahunda igaragara na serivisi mbere yo kwemeza paki.
- Guhindura ibice byavunitse muburyo bwimikorere. Ibyiciro bya AO / OTA bitegura ibisobanuro; ntibagaragaza uburebure bwa plaque, kubara umwobo, kuruhande cyangwa ibisabwa. Huza ibitekerezo byabaganga, ibyifuzo byamateka, kwiyandikisha no kuzuza ibimenyetso.
- Kwemera ubuziranenge rusange cyangwa imvugo igenga. Icyemezo cyuruganda, kwiyandikisha cyangwa ijambo 'titanium ' ntabwo byerekana ko ibicuruzwa byose byavuzwe bitwikiriye. Emeza urwego rwicyemezo, ibiranga ibicuruzwa, isoko ryerekanwe hamwe nurwego rwinshi.
Komeza verisiyo igenzurwa na mateka ya SKU kandi usabe inyandiko zerekana impinduka kubicuruzwa, ibikoresho, inganda-urubuga, ibikoresho cyangwa ibimenyetso byerekana impinduka. Icyitegererezo kirashobora gushyigikira isubiramo ryibanze, ariko ntirisimbuza imikorere, kutabyara cyangwa ibimenyetso byemewe. Komeza amasezerano yo gutanga hamwe ninshingano za serivisi zigaragara mugereranya.
9. Ni iki Abagabuzi Bakwiye Kubaza Utanga Amashanyarazi ya kure?
Ohereza ibibazo bimwe kubantu bose batanze urutonde hanyuma usabe ibisubizo byanditse. Intego ni ugukora tekiniki, amabwiriza nubucuruzi bigereranywa mbere yicyitegererezo cyangwa icyemezo cyo kugura.
- Ninde ukora amategeko yemewe kuri buri sahani yavuzwe, screw nibikoresho?
- Ni irihe zina nyaryo ry'ubucuruzi, icyitegererezo / SKU hamwe na catalogi ivugururwa kuri buri kintu?
- Ni ubuhe bwoko bwa volar, dorsal, rim, radial-inkingi cyangwa inkingi yo hagati yashyizwe murutonde rwubu?
- Ni ubuhe buryo bwibumoso / iburyo, uburebure bwa plaque hamwe nu mwobo uboneka ku isoko ryerekeza?
- Ni ubuhe bwoko bwa screw, ibipimo, ubwoko bwimodoka hamwe ninteruro yo gufunga bihuye na buri sahani?
- Ni ibihe bikoresho hamwe nibisanzwe bikurikizwa kuri buri cyatewe, kandi urashobora gutanga ibyemezo byinshi bihujwe?
- Nibihe bikoresho na tray bisabwa, bidashoboka, byongeye gukoreshwa cyangwa byavuzwe bitandukanye?
- Urashobora gutanga IFU iriho, ibirango, kuyobora tekinike, kataloge nibikoresho bihuza matrix?
- Ni izihe nyandiko zo kwiyandikisha, kwemererwa cyangwa guhuza zikubiyemo ibicuruzwa nyabyo kandi bigenewe gukoreshwa ku isoko ryacu?
- Ni ubuhe buryo budahwitse, ibipfunyika, amabwiriza yo kuboneza urubyaro hamwe nubuzima bwubuzima bwibintu byatanzwe?
- Nigute gusimbuza ibikoresho, kuzuza, guhindura ibicuruzwa, ibirego n'ibikorwa byo murwego byakemuwe bite?
- Kubikorwa bya OEM / Private-label umushinga, ninde ugenzura impinduka zishushanyije, ibyangombwa bya tekiniki, ibimenyetso hamwe ninkunga yihariye yo kwiyandikisha?
Saba buri gisubizo kugirango umenye ibicuruzwa no gushyigikira inyandiko zisubirwamo. Agatabo rusange cyangwa icyemezo cyikigo ntigenzura buri cyitegererezo. Shyira ahagaragara ibisubizo bidashyigikiwe 'bitaragenzurwa ' hanyuma ubikemure mbere yo kugura.
10. Ibibazo bikunze kubazwa kubyerekeye amasahani ya radiyo ya kure
Isahani ya radiyo ya kure ni iki?
Isahani ya radiyo ya kure ni iyatewe kugirango igoboke gukosora imvune zatoranijwe cyangwa osteotomies zirimo igice cyamaboko ya nyuma ya radiyo. Isahani nyayo, imigozi, ibikoresho nibikoresho byemewe biterwa na sisitemu yibicuruzwa hamwe na label yayo. Guhitamo ibikoresho nuburyo bwihariye, kandi uwabikoze IFU asobanura imikoreshereze yagenewe gukoreshwa.
Ni ubuhe bwoko bw'ingenzi bwa plaque ya kure?
Ibyiciro rusange byo kugura birimo ibyapa bifunga ibyapa, ibishushanyo mbonera bya volar bidafunze, ibyapa bya dorsal, hamwe na sisitemu yihariye igurishwa hamwe namazina nka DVR. Ibyiciro birashobora guhuzagurika, kandi igishushanyo nyacyo kigomba kugenzurwa kurutonde rwabakora na IFU. Amahitamo aratandukanye muri kontour, intera ya screw, kugenzura inguni nibikoresho.
Ni irihe tandukaniro riri hagati ya volar na plaque ya kure ya radiyo?
'Volar ' na 'dorsal ' basobanura uruhande rwa radiyo igenewe isahani. Isahani ya geometrie, gukwirakwiza ibice, inzira ya screw, ibikoresho bihuye hamwe na label biratandukanye. Umuganga wujuje ibyangombwa ahitamo kubaka; abagabuzi bagomba guhuza icyitegererezo cyasabwe na sisitemu ibyangombwa. Inzira nicyitegererezo bigomba gukurikiza gahunda yubuvuzi hamwe na label ikoreshwa.
AO / OTA 23 bivuze iki kumeneka ya radiyo ya kure?
'23 ' igaragara mumurage AO / OTA yerekanwe kuri radiyo ya kure. Mu byiciro byabantu bakuru 2018, radiyo yandikwa ukwayo kandi igice cya kure gikunze kumenyekana nka 2R3, hamwe na A, B na C mumatsinda adasanzwe, arigice-articular kandi yuzuye-arctular. Ibyiciro bisobanura morphologie yamenetse; ntabwo igena isahani yihariye cyangwa ingano yimigabane. Amatsinda mato agomba kugenzurwa muri compendium yemewe.
Ni ubuhe buryo bwuzuye ibikoresho bya radiyo yashyizweho bigomba kubamo?
Ongera usuzume inzira yakozwe nuwabigenewe asabwa isahani yatoranijwe hamwe nimiryango ya screw, nkibiyobora bihuza imyitozo, imyitozo, ibipimo byimbitse, abashoferi na tray. Emeza ibice bidahitamo, serivisi ikoreshwa-ibikoresho, isuku noguhindura amabwiriza, hamwe na matrix ihuza ubu. Baza niba tray yagurishijwe cyangwa yatijwe nuburyo ibikoresho byo gusimbuza bikorwa.
Nigute abakwirakwiza bagereranya abakora amasahani ya radiyo ya kure?
Gereranya ibicuruzwa nyabyo, icyitegererezo hamwe na SKU indangamuntu, ibimenyetso bifatika, guhuza ibikoresho no guhuza ibikoresho, uruhushya rwo kugana isoko-isoko, kwerekana sterile, inkunga ya serivisi n'amabwiriza yatanzwe. Koresha igitebo kimwe nibitekerezo kuri buri cote, hanyuma wandike ibimenyetso byose byerekana aho kubifata nkuko byemejwe. Saba inyandiko zijyanye na moderi yavuzwe, ntabwo ari rusange.
11. Kubaka Urutonde Rugereranijwe Mbere yo Gusaba Ingero
Tangira hamwe nimiryango isabwa hanyuma ukore matrike ya SKU kumpande, uburebure, imiterere yumwobo, imiyoboro ya screw nibikoresho. Ongeraho IFU iriho, ibimenyetso bifatika, igipimo cyagenwe, kwerekana sterile hamwe no kuzuza amagambo mbere yo kugereranya ibyifuzo.
Reba XC Medico ihahamuka, ibikoresho by'ihungabana kandi ihahamuka rya sisitemu portfolio . Kubikorwa byabigenewe, subiramo Serivisi za OEM / ODM no gusobanura inshingano z'umushinga.
Ukeneye ibiganiro-byo gushakisha isoko?
Sangira isoko ryerekanwe, wasabye imiryango isahani, igipimo cyibikoresho nibisabwa. XC Medico irashobora gufasha gushushanya iperereza ryibicuruzwa bijyanye n’ihungabana no gusobanura neza ibisobanuro n’inyandiko zigenga bigomba gusubirwamo inzira yatanzwe.
Inkomoko no Kuvugurura Inyandiko
Isubirwamo ku ya 11 Ugushyingo 2026. Inkomoko zikurikira zishyigikira ibyiciro n'amasoko; wemeze ibicuruzwa byubu byerekana icyitegererezo nisoko.
- Fondasiyo ya AO: AO / OTA Kumeneka no Gutandukanya Ibyiciro - 2018.
- Ishyirahamwe ry’ihungabana ry’amagufwa: OTA / AO Kumeneka no Gutandukanya Ibyiciro.
- AO Kubaga Reba: Ukuboko kwa kure.
- AO Kubaga Reba: Isahani ya Dorsal yo kuvunika igice-articular dorsal rim kuvunika.
- AO Kubaga Reba: Uburyo bwa Palmar ukoresheje uburyo bwa Henry bwahinduwe.
- AAOS / ASSH Amabwiriza yubuvuzi: Gucunga ibice bya radiyo ya kure.
- Amerika FDA: Amasahani y'amagufwa adafite umugongo, imigozi, hamwe no gukaraba - 510 (k) Amabwiriza yo gutanga.
- FDA 510 (k) incamake K161894 - urugero rwamabwiriza agenga amazina Ti-6Al-4V munsi ya ASTM F136 kuri sisitemu yihariye ya plaque na screw. Iyi nyandiko ntabwo ari gihamya kubindi bicuruzwa.
Icyitonderwa cyubwanditsi: Nibikoresho byamasoko, ntabwo ari inama zubuvuzi. Kugenzura ibirango biriho, uburenganzira, ibisabwa kwa muganga no guhuza mbere yo gutumiza.
