Sisiphi isishwankathelo soKhuseleko kunye neKlinikhi? - Zhongx

Esishwankathelo senkqubo yokhuseleko kunye nekliniki (i-SSCP) yenzelwe ukubonelela ngoluntu ukufikelela kuluntu kwisishwankathelo esihlaziyiweyo sezinto eziphambili zokhuseleko kunye nendlela yokusebenza kwekliniki.

I-SSSP ayijolise ekubuyiseleni imiyalelo yokusetyenziswa njengoxwebhu oluphambili ukuqinisekisa ukusetyenziswa kwesixhobo, okanye injongo yokubonelela ngoxilongo okanye izigulana.

Olu lwazi lulandelayo lwenzelwe abasebenzisi / abasebenzi bezempilo.

Ukuba i-SSCP iquka izigulana, kulandelayo oku kulandelayo: Ukulandela olu lwazi kukho isishwankathelo esenzelwe abaguli.

1. 1. Isixhoboisazisi kwaye jikelele Ulwazi
2. 1. Igama lorhwebo lwesixhobo

Inkqubo ye-POSTERVICAL

1.2.  Igama lomvelisi kunye nedilesi

Igama lomvelisi: I-Beijing Chunlizhengda kwezonyango co., idilesi ye-LTD: hayi. I-10 xinmi esentshona ye-West 2nd, kwingingqi ye-Tongzhou Dest Copy, Tongzhou District, Beijing, i-101112, China

1.3.  Inombolo yobhaliso olunye (SNSn)

SRN: CN-MF-000019514

1.4.  Isiseko-idi-di

Nceda ubhekise kwi-22-Cl-CE-2-001-001-0004 esisiseko-idi-di yenkqubo yokulungisa yasekhaya.

1.5.  Inkcazo yefowuni yezonyango inkcazo / isicatshulwa

Ikhowudi ye-EMDN kunye nenkcazo

Ikhowudi p09070301

I-Prostheses yaseburhulumenteni yaseburhulumenteni yokuzinza kunye neenkqubo

1.6.  Iklasi yesixhobo

Iklasi ye-IB, ngokutsho kwe-ANNEX VIII ye-MDR.

1.7.  Unyaka xa isatifikethi sokuqala (CE) sakhutshwa isigqubuthelo

I-Chunlizhengda ifumene ukumakisha inkqubo yangaphandle ye-ANTAREART ephantsi kwe-93/42 / i-EEC ngonyaka ka-2020

1.8.  Ummeli ogunyazisiweyo ukuba uyasebenza; Igama kunye neSNS

Igama: I-Mednet Ec-Red C III GMBH

SRN: De-Ar-0000111196

1.9.  Igama le-NB (i-NB eliya kuqinisekisa i-SSCP) kunye nenombolo ye-NB

Igama: I-TÜV Süd Inkonzo yeMveliso yeGergh

Inombolo yesazisi: 0123

2. 2. Yenzelwesebenzisa ye i isixhobo

2.1.  Yenzelwe injongo

Inkqubo yokulungisa engasemva iqulethe uthotho ezimbini. Inkqubo yokulungisa yenzelwe ukukhuthaza ukufundela i-fungelo ye-cervical spine kunye ne-cacipico-cervico-thoracico-t3). Inkqubo yokulungiswa engasemva iqulathe iintlobo ezahlukeneyo zeeplati kunye nobukhulu beeplate, iintonga, i-rosslink (i-rosslicle / i-Hook), isikrelem, i-screws, i-screen kunye ne-screw kunye ne-screen dibanisa kunye ne-screw kunye ne-screen.

2.2.  Isalathiso (s) kwaye Ithagethi abantu (s)

Isalathiso:

• Isifo se-discnetionation discnetionation (DDD) (Intlungu yentsebenzo ye-radgennic specincic ehambelana ne-disc kwi-disc njengoko iqinisekisiwe yimbali yembali yesigulana kunye nezifundo ze-radity);

I-2) Spondylolisthes;

3) stenosis;

4) ukwaphuka / ukufuduswa;

I-5) I-Atlanto / i-axial uqhekezo lokungazinzi;

I-6) Ukufuduswa kwe-ostitoigovication;

7) Ukuhlaziywa kovavanyo lweSpine lwangaphambili;

8) amathumba

2.3.  Ukuphikisana kunye / okanye imida

Ukuphikisana kubandakanya, kodwa akupheleli kuzo:

Ukukhetha ubungakanani obufanelekileyo, ubume kunye noyilo lokufakwa kwempahla kwisigulana ngasinye sibalulekile kwimpumelelo yenkqubo. Olu luhlu lwezeminyhaka elinokubakho lubandakanya:

1. Inkqubo yosulelo esebenzayo okanye umngcipheko obalulekileyo wosulelo (i-Ignocompromise).
2. Iimpawu zokuvusa kwendawo.
3. Umkhuhlane okanye i-leukicytosis.
4. I-morbid oblity.
6. Isigulo sengqondo.
7. I-anatomy ye-anatomy egqwethekileyo ebangelwa kukungabi nangqondo.
8. Nakuphi na ezinye iindlela zonyango okanye zonyango ezinokuthi zithintele isibonelelo esinokubakho sotyando oluthengiswayo sisiqhulo, njengobukho bokungaqhelekanga, ukuphakama kwe-SEDGEENT SITHORTATION.
9. Ukrokrelwa okanye ukubhalwa kwentsimbi okanye ukunganyamezelani.
10. Naliphi na ityala alikufuni ububi lwethambo kunye ne-fusion.
11. Nayiphi na imeko apho izinto ezimiselweyo ezikhethiweyo zokusetyenziswa ziya kuba zinkulu kakhulu okanye zincinci kakhulu zokufezekisa iziphumo eziphumelelayo.
12. Nasiphi na isigulana esingenasiphelo se-tissies esingaphelelanga kwisiza se-pies okanye esingasebenziyo sethambo okanye umgangatho.
13. Nasiphi na isigulana apho ukusetyenziswa kwedatha kuya kuphazamisa izakhiwo ze-anatomical okanye kulindelwe ukusebenza komzimba.
14. Nasiphi na isigulana esingafuniyo ukulandela imiyalelo yendawo.

Ityala le-15.nani alichazwanga kwizimpawu ezibonakalayo.

3. Inkcazo yesixhobo

3.1.  Inkcazo ye i isixhobo

Inkqubo yokulungisa engasemva iqulethe uthotho ezimbini. Inkqubo yokulungisa yenzelwe ukukhuthaza ukufundela i-fungelo leSpine kunye neCicipico-Cervico-Thoracy Junction (i-sticvic-T3), esetyenziselwa ukulungisa i-vertebrae yezigulana zasekhaya.

Izixhobo zinikezelwa kwi-non-engs. Kuyadingeka ukuba ichithwe ngendlela ye-autoclave ukufikelela kwi-10-6 isibhedlele ngaphambi koqhaqho. Indlela yokwazisa i-Sterilization iqinisekisiwe kwi-ISO ye-ISO 17665-1.

3.2.  A ireferensi ukuya ngaphambili Ukuvelela (s) okanye eyahlukileyo ukuba ezo zinto zikhona, kwaye a Inkcazo ye i umahluko

Ayingeni. Akukho sizukulwana sangaphambili.

3.3.  Inkcazo ye Nantoni na izixhobo yeyiphi zikhona yenzelwe ukuya yiba isetyenzisiwe ngaphakathi indibaniselwano nge i isixhobo

Ayingeni. Akukho zixhobo zesi sixhobo.

3.4.  Inkcazo ye Nantoni na enye izixhobo kwaye iimveliso yeyiphi zikhona yenzelwe ukuya yiba isetyenzisiwe Ngokudibeneyo nesixhobo

Ayingeni. Isixhobo senzelwa ukuba sisetyenziswe ngokudibeneyo naziphi na izixhobo kunye neemveliso.

4. 4. Umngciphekokwaye Izilumkiso

4.1.  Intsalela umngcipheko kwaye ukungafuneki iziphumo

Uhlalutyo olubanzi lwawo wonke umngcipheko oshiyekileyo lwenziwe liqela lephononongo. Ukujonga isiphumo esidityanisiweyo sayo yonke imingcipheko yentsalela nganye, isiphelo sokugqibela sitsalwa ukuba imveliso ebanzi yemveliso ingekamkelwa. Uvavanyo oluneenkcukacha ludweliswe ngolu hlobo lulandelayo:

1) Ngaba ulawulo lomngcipheko ngamnye wokuchasana?

Ukuqukumbela: Akukho luganga lobuthathaka sele lufunyenwe ekuchazeni.

2) Uvandlakanyo lwemiyalelo (E.G. Ngaba ikhona inkcazo echaseneyo? Ngaba kukho umgaqo onzima wokulandela?)

Ukuqukumbela: Imiyalelo yemveliso ihambelana neemfuno zeMigaqo eDibeneyo. Iinkcazo ezinxulumene nemveliso zicacile kwaye kulula ukuyiqonda.

3) uthelekisa iimveliso ezifanayo

Isiphelo: Xa uthelekiswa nezixhobo ezifanayo kwintengiso ekliniki, kwiipropathi kunye nemiba yemicimbi. Intsebenzo yemveliso iyafana kwezi zixhobo. Ke ngoko bagwetywa ukuba babe nepropathi efanayo kwesi sixhobo.

• Ukuqukumbela Iqela Lovavanyo

Ukuqukumbela: Isiphelo sokugqibela kufikelelwe kulapho uvavanyo oluphanga ngasentla olunokwamkelwa.

4.2.  Izilumkiso kwaye ukulumkela

Izilumkiso:

Ukhuseleko kunye nokusebenza kwe-pedicle screw spinal iinkqubo zisekwe kuphela kwiimeko zesikhumba kunye nokungazithembi kakuhle okanye ukungcungcutheka okufuna ukufunyanwa kwesixhobo. Ezi meko zizinto ezibalulekileyo zokungazinzanga okanye ukungcungcutheka kwe-thoracic, i-lumbar, kunye ne-sacrory spinery spondylolist ezinobungqina benjongo ye-neurondylologic ye-neurondiclologic, i-scoliosis, i-kyphosis, kwaye ihlulekile i-fuudarthrosis yangaphambili. Ukhuseleko kunye nokusebenza kwesi sixhobo kuyo nayiphi na enye imeko ayaziwa. Ukufakwa kwentengiso akuvuswanga. Ngaphandle kokungabikho kwe-fusion, isixhobo kunye / okanye okanye esinye okanye ngaphezulu kwamacandelo ayo kunokulindeleka ukuba sikhuphe, sigobe okanye sityhafile ngenxa yokuvezwa koxinzelelo lwemihla ngemihla.

Ukulumkela：

1. Ugqirha utyando kufuneka abe nobuchule ekusebenzeni kwezixhobo kunye nokufakwa kwezinto, amava angcono kuvavanyo lwe-spinal;
2. Ugqirha kufuneka avavanye isigulana phambi kotyando, kwaye igwebe ukuba ifanelekile ukusebenzisa impahla yokufakelwa ngokobunzima bomguli, imeko, imeko yengqondo, nokuba ayilunganga nakwesi sifo; Iinkcazo zemodeli ezifanelekileyo kufuneka zikhethwe ngokwemeko yakho yesigulana. Ngaphambi kotyale, ukufakwa kweentlobo ezahlukeneyo kunye neenkcazo kufuneka zilungiswe, kwaye utyando akufuneki lwenziwe ngaphandle kokulungiselela okwaneleyo;
3. Ukuba i-implatent yaphukile, igxothwe, igxothiwe, isuswe, ilahleko okanye ilahleko yethambo, i-implant kufuneka ithathelwe ingqalelo ukususwa.
4. I-implant ayiyi kuqwalaselwa okanye iguqulwe nangayiphi na indlela ngaphandle kokuba ivunyelwe yiyilo kwaye njengoko kuchaziwe kwincwadana yezobugcisa. Kulumkele ukulungisa, ukugoba, ukusika okanye ukukrwela ukufakelwa ukuthintela ukusilela kwayo.
5. Izigulana kufuneka zithathe inxaxheba kwimisebenzi ethintelayo ekhoyo phantsi kwesikhokelo sikagqirha ukuthintela ukungaphumeleli kwemveliso kunye neengxaki ezibangelwe yimisebenzi ephezulu okanye ubunzima emva kotyando.
6. Izigulana kunye neentsapho zabo kufuneka zazi ukuba iingxaki zeposi kunye neziphumo ebezingalindelekanga.
7. Umhla wokuphelelwa kwale mveliso: unyaka emva kokufakwa emzimbeni womntu okanye njengoko kuyalelwe ngugqirha.

4.3.  Enye efanelekileyo imiba ye ukhuseleko, kubandakanya a isishwankathelo ye Nantoni na intsimi ukhuseleko ukulungisa isenzo (Fsca kubandakanya I-FSN) ukuba isebenza

Ayingeni