Ndeipi pfupiso yekuchengetedza uye clinical performance? - Zhongxing

Pfupiso iyi yekuchengetedza uye Clinical performance (SSCP) inoitirwa kupa veruzhinji kuwana kune yakagadziridzwa pfupiso yezvinhu zvakakosha zvekuchengetedza uye clintical performance yechigadzirwa.

Iyo SSCP haina kuitirwa kutsiva mirairo yekushandiswa segwaro guru kuve nechokwadi chekushandisa kwakachengeteka kwechishandiso, kana kuti chakagadzirirwa kupa idzo mazano kana ekurapa mazano kune vashandisi kana varwere.

Ruzivo runotevera rwunoitirwa vashandisi / hutano hwehutano.

Kana iyo SSCP inosanganisira varwere, zvinotevera zvinogona kuwedzerwa: Kutevera ruzivo urwu pane pfupiso inoitirwa varwere.

1. 1. Mudziyokuzivikanwa uye General Ruzivo
2. 1. Chishandiso zita rekutengeserana (s)

Posterior Cervical Fixation System

1.2.  Mugadziri zita uye kero

Zita reMugadziri: Beijing chunLizengda zviridzwa CO., kero yeLTD. Vagadziri: Kwete. 10 Xinmi West 2nd Road, South Dunhu reSouth Africa Economic Development Zone, Tongzhou District, Beijing, 101112, China

1.3.  Mugadziri's Single Kunyoresa Nhamba (SRR)

SRRN: CN-MF-000019514

1.4.  Basic-Udi-di

Ndokumbira utarise kuna 22-CL-CE-2-001-0004 Basic-Udi-di yePosterior Cervical Fixation System.

1.5.  Medical mudziyo womenclature tsananguro / zvinyorwa

EMDN Code uye Tsananguro

Code P09070301

Yepamutemo term spine stybilation prosthes uye masystem

1.6.  Kirasi yemudziyo

Kirasi iib, maererano neAnnex viii yeMDR.

1.7.  Gore kana chitupa chekutanga (CE) chakapihwa chifukidzo chishandiso

ChunLizengda yagamuchira CE CE KUSVIRA CERICE CERVICAL Cervical System Directive 93/42 / EEC MU 2020 gore

1.8.  Mumiriri Akatenderwa kana zvichiita; zita uye rakashambidzirwa

Zita: Mednet EC-Rep C III GMBH

SRRN: De-Ar-000011196

1.9.  NB IZita reNB (iyo NB iyo ichasimbisa iyo SSCP) uye iyo NB's yeNB yakazivikanwa nhamba

Zita: Tüv Süd Chigadzirwa Service GmbH

Nhamba Yekuzivikanwa: 0123

2. 2. Chinangwashandisa of the the mudziyo

2.1.  Chinangwa Chinangwa

Iyo posterior cervical fixation system ine maviri akatevedzana. Iyo nzira yekugadzirisa inoitirwa kukurudzira kupamhama kweiyo cervical spine uye occipito-cervico-thoracic junction (occiput-t3). Iyo posterior cervical gadziriso inosanganisira akasiyana maumbirwo uye masaga emapuranga, rodslink

2.2.  Chiratidzo (s) uye chinangwa huwandu hwevanhu (s)

Zviratidzo:

• Dhezheni yeDiscer

2) Spondylolistisis;

3) Spinal Stenosis;

4) kupwanya / dislocation;

5) Atlatate / axial kupwanya nekusagadzikana;

6) Occipitocervical dislocation;

7) Kudzokorora kwekuvhiyiwa kwakapfuura kwechikepe;

8) Tumi

2.3.  Kukanganisa uye / kana zvisingakwanisi

Kupesana kunosanganisira, asi hazvigone kugumira:

Iko kusarudzwa kwehukuru hwakakodzera, chimiro uye dhizaini yekuisa iyo murwere mumwe nemumwe akakosha pakubudirira kwehungwaru. Izvi zvinotevera kunyorwa kwezviitiko zvinogona kutsamwisa zvinosanganisira:

1. Inoshanda inotapukira maitiro kana njodzi yakakosha yehutachiona (impunompomise).
2. Zviratidzo zvekuzvimba kwenzvimbo.
3. Fivha kana leukocytosis.
4. Morbid fudza.
6. Kurwara kwepfungwa.
7. Yakanyanyisa yakakwenenzverwa anatomy inokonzerwa nekuzvarwa zvisina kujairika.
8. Chero mamwe mamiriro ekurapa kana ekuvhiya angatangira mukana wekubhadhara kwekuvhenekwa kwemapurusi, sekusimudzira kwezvirimwa zveropa, kana kucherechedzwa kwekuruboshwe.
9. Kufungidzirwa kana kunyorwa simbi allergy kana kusashivirira.
10. Chero nyaya isiri kuda graft yefuma uye fusion.
11. Chero nyaya iyo iyo nzvimbo dzekuisa dzakasarudzwa kuti dzishandise dzaigona kuve dzakanyanya kana zvidiki kuti uwane zvakabudirira mhedzisiro.
12. Chero murwere ane isina kukwana tishusu couring pamusoro peiyo inoshanda saiti kana isina kukwana pfupa kana mhando.
13. Chero murwere mune iyo implant yekushandisa yaizopindira nemidziyo yezvivakwa kana zvaitarisirwa kuita basa.
14. Chero murwere asingade kutevedzera mirayiridzo yekutevera.

15.Nyitiko chiitiko chisina kutsanangurwa mune zvinoratidza.

3. Tsanangudzo Chishandiso

3.1.  Tsanangudzo of the the mudziyo

Iyo posterior cervical fixation system ine maviri akatevedzana. Iyo nzira yekugadzirisa inoitirwa kukurudzira kupamhama kwechibereko chechibereko uye occipito-cervico-cervicic junction (occipic-t3), iyo inoshandiswa kugadzirisa iyo anterior cervical verters yerwere.

Midziyo yacho inopiwa mune isiri-isina. Izvo zvinodikanwa kuti uve wakasvibiswa kuburikidza neAutoclave nzira kuti usvike munyu wegumi-6 muchipatara usati wavhiyiwa. Nzira yakakurudzirwa yakasimbiswa yaishandiswa pa ISO 17665-1: 2006 Stellization yehutano hwehutano

3.2.  A Reference kuti yapfuura chizvarwa (s) kana Variya Kana zvakadaro kuvapo, uye a Tsanangudzo of the the Misiyano

Hazvigoneke. Iko hakuna chizvarwa chakapfuura.

3.3.  Tsanangudzo of chero accessories izvo vari chinangwa kuti be yakashandiswa mukati kusanganisa na the the mudziyo

Hazvigoneke. Iko hakuna accessories yeichi chishandiso.

3.4.  Tsanangudzo of chero zvimwe zvishandiso uye zvigadzirwa izvo vari chinangwa kuti be yakashandiswa Mukubatanidzwa ne mudziyo

Hazvigoneke. Mudziyo hauna kuitirwa kuti ushandiswe musanganiswa uine chero zvimwe zvigadzirwa uye zvigadzirwa.

4. 4. Njodziuye Yambiro

4.1.  Vakasara Njodzi uye zvisingadiwe Mhedzisiro

Kuongororwa kwakazara kweiyo yese yakasara njodzi yakaitwa neiyo timu yekudzokorora. Kufunga zvakabatanidzwa nemhedzisiro yemunhu wese akasara ane njodzi, mhedzisiro yekupedzisira inodhonzwa kuti chigadzirwa chakazara nenjodzi yakasara inogona kugamuchirwa. Iyo ongororo yakadzama yakanyorwa seinotevera:

1) Ndedzipi njodzi dzoga dzinodzora mukupokana?

Mhedziso: Hapana njodzi dzakaipa dzisati dzawanikwa mukupokana.

2) Ongororo yemirairo (i.e. iripo pane kurondedzerwa kurondedzerwa? Pane chero mutemo wakaoma kutevera?)

Mhedziso: Mirayiridzo yechigadzirwa inotevedzera zvinodiwa nemutemo wakabatana. Tsananguro dzinoenderana nechigadzirwa dzakajeka uye nyore kunzwisisa.

3) Kuenzanisa nezvigadzirwa zvakafanana

Mhedziso: Kuenzaniswa nezvinhu zvakafanana nemusika mumusika mune kiriniki, zvivakwa uye zviitwa zvinhu. Zvigadzirwa zvekuita zvakafanana nemidziyo iyi. Saka ivo vanotongwa kuti vave nemidziyo yakafanana neiyi kifaa.

• Mhedziso yeThe Yekudzokorora Team

Mhedziso: Mhedziso yekupedzisira yasvika kuburikidza neyekuongororwa pamusoro pekuti iyo chigadzirwa chakakwana njodzi njodzi inogona kugamuchirwa.

4.2.  Yambiro uye zvekungwaririra

Yambiro:

Kuchengeteka uye kushanda kwePedicle Screen Spinal Systems yakagadziriswa chete kune iyo musana mamiriro ane hunyanzvi hwekusagadzikana kana kuremara kunoda kufungidzira nechiridzwa nechishandiso. Aya mamiriro akakosha mechancal kusagadzikana kana kuremara kweiyo thoracic, lumbar, uye spine Spine sekisimusi yekukanganisa Iko kuchengetedzwa uye kushanda kweichi chishandiso kune chero mamwe mamiriro asingazivikanwe. Izvo zvigaro hazvisi mapikicha. Mukushayikwa kwekufungidzira, chiridzwa uye / kana chimwe kana chimwe kana chimwe chezvikamu zvacho zvinogona kutarisirwa kudhonza kunze, kukotama kana kupwanya semhedzisiro yekufumurwa kwemazuva ese ekushushikana.

Zvekungwaririra：

1. Chiremba anovhiya anofanira kunge ane hunyanzvi mukushanda kwemidziyo uye zvigaro, chiitiko chiri nani mukuvhiyiwa kwespinal;
2. Chiremba anofanira kuongorora murwere asati avhiya, uye otonga kuti zvakakodzera kushandisa zvigaro zvinoenderana nehuremu hwemurwere, mamiriro ezvinhu epfungwa, angave anonamira kune vekunze muviri, uye nzira yechirwere; Iyo inoshanda yemhando yakatarwa inofanirwa kusarudzwa zvinoenderana nemamiriro emurwere. Asati avhiya, magetsi emhando dzakasiyana uye madudziro anofanirwa kuve akagadzirira, uye kuvhiya hakufanirwe kuitwa pasina kugadzirira kwakakwana;
3. Kana iyo Implant ikaputswa, yakadzingwa, yakavhunika, yakasununguka, hutachiona kana kurasika kwepafupa, iyo yekuisa inofanira kutariswa nekubviswa.
4. Iko kusimbisa hakuzogone kuongororwa kana kuchinjwa munzira ipi neipi kunze kwekubvumidzwa nekugadzira uye sezvakataurwa mune yehunyanzvi bhuku. Regedza kururamisa, kukotama, kucheka kana kutapudza kana kukwenya magetsi kudzivirira kutadza kwayo.
5. Varwere vanofanira kuzoshandiswa mabasa ekudzora pasi pekutungamirirwa nachiremba kuti vadzivise kutadza kwechigadzirwa uye matambudziko akakonzerwa nekunyanyisa kuita kana kuremerwa mushure mekuvhiyiwa mushure mekuvhiyiwa.
6. Varwere nemhuri dzavo vanofanira kuziva nezvezvisikwa zvedzidzo uye zvinokwanisika mhedzisiro.
7. Zuva rekupedzerwa kwechigadzirwa ichi: gore rimwe mushure mekubviswa mumuviri wemunhu kana sekurairwa nachiremba.

4.3.  Zvimwe zvinoenderana Zvimiro of kuchengeteka, kusanganisira a Pfupiso of chero munda kuchengetedzwa kururamisa chiito (FSCA kusanganisira Fsn) Kana zvinoshanda

Hazvigoneke