Yisiphi isifinyezo sokuphepha nokusebenza komtholampilo? - I-Zhongxing

Lesi sifinyezo sokuphepha kanye nokusebenza komtholampilo (i-SSCP) senzelwe ukuhlinzeka ngokufinyelela komphakathi esifisweni esibuyekeziwe sezinto eziphambili zokuphepha nokusebenza kwensiza.

I-SSCP ayihloselwe ukufaka imiyalo yokusebenzisa njengodokhumenti oyinhloko ukuqinisekisa ukusetshenziswa okuphephile kwensiza, futhi akuhloselwe ukuhlinzeka ngeziphakamiso zokuxilonga noma iziguli.

Imininingwane elandelayo yenzelwe abasebenzisi / abaqeqeshiwe bezempilo.

Uma i-SSCP ifaka iziguli, okulandelayo kungangezwa: Ukulandela lolu lwazi kunesifinyezo esihloselwe iziguli.

1. 1. Iceboukukhonjwa na- jwayelekile ulwazi
2. 1. Igama (s) yedivayisi

Isistimu yokulungiswa kwesibeletho

1.2.  Igama Lomenzi nekheli

Igama Lomkhiqizi: Beijing Chunlizhengda Medical Instrumetion Meyield Co, Ltd. Ikheli Lomenzi Womkhiqizi: Cha. I-10 XINMI West 2nd Road, esifundeni saseTongzhou Secondoc Development Second, I-Tongzhou District, Beijing, 1011112, China

1.3.  Inombolo yokubhalisa eyodwa ye-Breansit (SRN)

SRN: CN-MF-000019514

1.4.  Eziyisisekelo-udi-di-di

Uyacelwa ukuthi ubheke ku-22-CL-CE-2-001-0004 Basic-Udi-Di-DI ohlelweni lokulungiswa kwesibeletho lwangemuva.

1.5.  Incazelo ye-Medical Service Menclature / umbhalo

Ikhodi ye-EMDN nencazelo

Ikhodi p09070301

I-Official Tem Official Spine Snsilization Prefeseses nezinhlelo

1.6.  Isigaba sedivayisi

I-Class IIB, ngokusho kuka-Annex VIII we-MDR.

1.7.  Unyaka lapho isitifiketi sokuqala (CE) sikhishwe ukumboza insiza

UChunlizhengda uthole ukumaka kwe-CE kohlelo lokulungiswa komlomo wesibeletho ngaphansi kokwenza isiqondisi 93/42 / EEC ngonyaka wama-2020

1.8.  Ummeleli ogunyaziwe uma kusebenza; Igama ne-SRN

Igama: Mednet EC-Rep C III GmbH

SRN: de-ar-000011196

1.9.  Igama likaNB (i-NB ezoqinisekisa i-SSCP) nenombolo kamazisi ye-NB

Igama: Tüv Süd Service GmbH

Inombolo kamazisi: 0123

2. 2. -Ncindisebenzisa iwa- le khasi icebo

2.1.  -Ncindi okuhlosiwe

Uhlelo lokulungiswa kwangemuva lwangemuva luqukethe uchungechunge olubili. Uhlelo lokulungiswa kwenzelwe ukukhuthaza ukuhlanganiswa komgogodla wesibeletho kanye ne-occipito-cervico-thoracic Junction (Occiptut-T3). Uhlelo lokulungiswa kwangemuva lwangemuva luqukethe izinhlobo ezahlukahlukene zosayizi nosayizi wamapuleti, izinduku, i-crosslink (exhunyiwe (ipuleti elixhunyiwe), izikulufo, i-hook, amalunga aseceleni bese usetha isikulufa bese usetha isikulufa bese usetha isikulufa.

2.2.  Izinkomba (s) na- okuqondiwe Inani (s) labantu

Izinkomba:

• Isifo se-Disc Disc (DDD) (izinhlungu zentamo zemvelaphi ye-discogenic ngokuwohloka kwe-disc njengoba kuqinisekiswe umlando wesiguli kanye nezifundo ze-radiographic);

2) spondylolisthesis;

3) i-stenosis yomgogodla;

4) Ukuqhekeka / ukuhlukaniswa;

5) I-Atlanto / Axial Fracture ngokuntengana;

6) I-OccipitocoCical disloation;

7) Ukubuyekezwa kokuhlinzwa komgogodla owedlule;

8) Tumors

2.3.  Contraindications kanye / noma ukulinganiselwa

I-Contraindication ifaka, kepha ayikhawulwanga ku:

Ukukhethwa kosayizi ofanele, ukwakheka kanye nokwakheka kokufakelwa kwesiguli ngasinye kubalulekile empumelelweni yenqubo. Okulandelayo kokufakwa kuhlu kwezehlakalo ezingezinhle ezingezinhle zifaka:

1. Inqubo esebenzayo noma ingozi enkulu yokutheleleka (i-ImmunoCompromise).
2. Izimpawu zokuvuvukala kwasendaweni.
3. Umkhuhlane noma i-leukocytosis.
4. Ukukhuluphala kwe-morbid.
6. Ukugula kwengqondo.
7. I-anatomy ehlanekezelwe kakhulu ebangelwa ukungahambi kahle kokuzala.
8. Noma yisiphi esinye isimo sezokwelapha noma sokuhlinzwa esizovimbela inzuzo engaba khona yokuhlinzwa komgogodla, njengokuba khona kwezinga lokuzala, ukuphakama kwezinga lokuzala okungachazwanga ezinye izifo, ukuphakanyiswa kwesibalo segazi esimhlophe (i-WBC) ukubala kokuhlukaniswa kwe-WBC.
9. Okusolwayo noma okubhalwe phansi kwensimbi noma ukungabekezeleli.
10. Noma yiliphi icala elingadingi ukuhlanganiswa kwethambo kanye nokuhlanganiswa.
11. Noma yiliphi icala lapho izingxenye zokufakelwa ezikhethwe ukusetshenziswa zingaba zizinkulu kakhulu noma zincane kakhulu ukufeza umphumela ophumelelayo.
12. Noma yisiphi isiguli esinokuvalwa kwezicubu okunganele ngaphezulu kwesiza sokusebenza noma isitoko sethambo noma ikhwalithi enganele.
13. Noma yisiphi isiguli lapho ukusetshenziswa kwe-invant kuvame ukuphazamisa izakhiwo ze-anatomical noma ukusebenza okulindelekile.
14. Noma isiphi isiguli esingafuni ukulandela imiyalo ye-postoperative.

Icala le-15.Ay.

3. Ukuchazayo

3.1.  Ukufanisa iwa- le khasi icebo

Uhlelo lokulungiswa kwangemuva lwangemuva luqukethe uchungechunge olubili. Uhlelo lokulungiswa kwenzelwe ukukhuthaza ukuhlanganiswa komgogodla wesibeletho kanye ne-occipito-cervico-thoracic Junction (I-Occiptut-T3), esetshenziselwa ukulungisa i-anterior vertebrae yeziguli.

Amadivayisi anikezwa ngokungathathili. Kudingeka ukuthi kufakwe inzalo nge-autoclave indlela yokufinyelela esitokisini se-10-6 esibhedlela ngaphambi kokuhlinzwa. Indlela yokufaka inqwaba yaqinisekiswa nge-ISO 17665-1: 2006 inzalo yemikhiqizo yokunakekelwa kwezempilo - Ingxenye 1: Izidingo zokuthuthukiswa kwentuthuko, ukuqinisekiswa, kanye nokulawulwa kwenqubo yenhlangano yamadivayisi wezokwelapha.

3.2.  A inkomba kwa- -kwakuqala Isizukulwane (S) noma okuhlukile nxa -njalo zikhona, na- a ukufanisa iwa- le khasi ukwehluka

Akufaneleki. Asikho isizukulwane esedlule.

3.3.  Ukufanisa iwa- -ma yini okwengezayo -phi bakhona -ncindi kwa- yiba -setshenzisiwe phakathi kwa- inhlanganisela ne- le khasi icebo

Akufaneleki. Azikho izesekeli zale divayisi.

3.4.  Ukufanisa iwa- -ma yini -nye nje amadivayisi na- imikhiqizo -phi bakhona -ncindi kwa- yiba -setshenzisiwe Ngokuhambisana nedivayisi

Akufaneleki. Idivayisi ayihloselwe ukusetshenziselwa ukuhlanganiswa namanye amadivaysi nemikhiqizo.

4. 4. Ubungozina- Izexwayiso

4.1.  Okuseleyo ubungozi na- -ngathandeki umphumela

Ukuhlaziywa okuphelele kwazo zonke izingozi ezisele zenziwe yiqembu lokubuyekezwa. Uma kucatshangelwa umphumela ohlanganisiwe wazo zonke izingozi ezisaseleyo, isiphetho sokugcina sidonswa ukuthi ubungozi obukhulu obunensabelo bungamukelwa. Ukuhlolwa okuningiliziwe kufakwe kuhlu kanjena:

1) Ingabe izilawuli zobungozi ngazinye ziyaphikisana?

Isiphetho: Azikho izilawuli zobungozi ezingakaze zitholakale ziphikisana.

2) Ukubuyekezwa kwemiyalo (e.g. Ngabe kukhona yini incazelo ephikisanayo? Ngabe kukhona okunzima ukulandela umthetho?)

Isiphetho: Imiyalo yomkhiqizo ihambisana nezidingo zomthethonqubo ohlobene. Izincazelo ezihlobene nomkhiqizo zicacile futhi kulula ukuziqonda.

3) ukuqhathanisa nemikhiqizo efanayo

Isiphetho: Uma kuqhathaniswa namadivayisi afanayo emakethe emtholampilo, izakhiwo kanye nokwenza izinto. Ukusebenza kwemikhiqizo kuyafana nalawa madivayisi. Ngakho-ke bahlulelwa ukuba babe nezindawo ezifanayo kuleyo divayisi.

• Isiphetho seqembu lokubuyekezwa

Isiphetho: Isiphetho sokugcina sesifinyelelwe kulolohlolo olungenhla ukuthi ubungozi obubanzi bomkhiqizo bungamukelwa.

4.2.  Izexwayiso na- izinyathelo zokuzivikela

Izexwayiso:

Ukuphepha kanye nokusebenza ngempumelelo kwezinhlelo zomgogodla ohleliwe kuphela ngezimo zomgogodla ezinokungazinzi okubalulekile kwemishini noma ukudabuka okudinga ukuhlanganiswa ngensimbi. Lezi zimo zingukungazinzi okuthe xaxa noma ukuwohloka kwe-thoracic, i-lumbar, kanye nomgogodla we-sacral, kanye ne-sacral spine ku-degenerative spondylolisthesis ngobufakazi bezinhloso zokulimazeka kwe-neurondwolic, i-scoliosis, i-spinesion yomgogodla (pseudarthsosis). Ukuphepha nokusebenza kahle kwale divayisi yanoma yiziphi ezinye izimo akwaziwa. Izimila azizona ama-propstheses. Uma kungekho i-fusion, i-anstration kanye / noma eyodwa noma ngaphezulu kwezakhi zayo kungalindeleka ukuthi kukhishwe, kugoqwe noma ukuqhekeka ngenxa yokuchayeka ezinhlotsheni zansuku zonke zemishini.

Izinyathelo zokuzivikela：

1. Udokotela ohlinzayo kufanele abe nekhono ekusebenzeni kwemishini nezimila, okuhlangenwe nakho okungcono kokuhlinzwa komgogodla;
2. Udokotela kufanele ahlole isiguli ngaphambi kokuhlinzwa, futhi ahlulele ukuthi kufanelekile yini ukusebenzisa izimila ngokuya ngesisindo sesiguli, umsebenzi, ukuqina komsebenzi, isimo sengqondo, noma kunjalo, isifundo salesi sifo; Ukucaciswa kwamamodeli okusebenzayo kufanele kukhethwe ngokwesimo sesiguli uqobo. Ngaphambi kokusebenza, izimila zezinhlobo ezahlukene kanye nokucaciswa kufanele zilungiselelwe, futhi ukuhlinzwa akumele kwenziwe ngaphandle kokulungiselela okuhle kakhulu;
3. Uma ukufakwa kuphukile, kukhishwe ngaphandle, okuphangiwe, ukutheleleka, ukutheleleka noma ukulahleka kwamathambo, ukufakwa kufanele kubhekwe ukuze kususwe.
4. Ukufakelwa ngeke kucutshungulwe noma kushintshwe nganoma iyiphi indlela ngaphandle kokuthi kuvunyelwe yi-Design futhi njengoba kuchaziwe kwincwajana yezobuchwepheshe. Gwema ukulungiswa, ukugoqa, ukusika noma ukuklabha izimila ukuvikela ukwehluleka kwalo.
5. Iziguli kufanele zisebenze ngemisebenzi emikhawulweni yemikhawulo engaphansi kokuholwa ngudokotela ukuvikela ukwehluleka komkhiqizo nezinkinga ezibangelwa umsebenzi owedlulele noma ukuthwala isisindo ngemuva kokuhlinzwa.
6. Iziguli nemindeni yazo kufanele zikwazi izinkinga zokusebenzisa imali kanye nemiphumela emibi engenzeka.
7. Usuku lokuphelelwa yisikhathi kwalo mkhiqizo: Ngonyaka owodwa ngemuva kokufakwa emzimbeni womuntu noma njengoba kuqondiswe udokotela.

4.3.  -Nye nje -qondene izici iwa- ukuphepha, na- a ukubeka kafushane iwa- -ma yini idlelo ukuphepha kokulungiswa ukwenza (I-FSCA na- I-FSN) nxa -qondene

Akufaneleki