Ni izihe ncamake y'umutekano n'imikorere ya Clinique? - Zhongxing

Iyi ncamake yumutekano na clinical imikorere (SSCP) igenewe gutanga amakuru rusange kuminota ivuguruye yibice byingenzi byumutekano nibikorwa byubuvuzi bwibikoresho.

SSCP ntabwo igamije gusimbuza amabwiriza yo gukoresha nkinyandiko nkuru kugirango ikoreshwe neza igikoresho, ntanubwo igamije gutanga ibitekerezo byo gusuzuma cyangwa gutanga ibitekerezo kubakoresha cyangwa abarwayi.

Amakuru akurikira agenewe abakoresha / abanyamwuga bashinzwe ubuzima.

Niba sscp ikubiyemo abarwayi, ibi bikurikira birashobora kongerwaho: Gukurikiza aya makuru Hariho incamake igenewe abarwayi.

1. 1. Igikoreshoindangamuntu na Rusange amakuru
2. 1. Izina ryubucuruzi (s)

Inshingano yinyuma yinkomoko

1.2.  Izina ry'abakora na aderesi

Izina ry'uwabikoze: Beijing Chunlizhengda ibikoresho by'ubuvuzi bya Co., Aderesi ya LtD.: Oya. 10 Xinmi Iburengerazuba bwa 2, Akarere ko mu majyepfo ya Zongzhou Ubukungu bwiterambere, Akarere ka Tongahou, Beijing, 101112, Ubushinwa

1.3.  Umubare wabigenewe (SRN)

SRN: CN-MF-000019514

1.4.  Shingiro-udi-di

Nyamuneka reba 22-CL-CHA-2-001-0004 shingiro-udi-di ya sisitemu yo gukosora inkondo y'inyuma.

1.5.  Igikoresho cyubuvuzi nomenclatire Ibisobanuro / Inyandiko

EDDN Code na Ibisobanuro

Kode P09070301

Ijambo ryemewe ryumugongo prostases na sisitemu

1.6.  Icyiciro cy'igikoresho

Icyiciro IIB, ukurikije Umugereka wa VIII ya MDR.

1.7.  Umwaka mugihe icyemezo cya mbere (CE) cyatanzwe gitwikiriye igikoresho

Chunlizhengda yakiriye amanota ya sisitemu yo gukosora intengusi yimbere munsi ya 93/42 / EEC mu mwaka wa 2020

1.8.  Uhagarariye uburenganzira niba bishoboka; Izina na SRN

Izina: Mednet EC-REP C III GmbH

SRN: DE-AR-000011196

1.9.  Izina rya NB (NB izemeza SSCP) numero imwe iranga NB

Izina: TÜV Süd Service Service GmbH

Inomero iranga: 0123

2. 2. Yagenewekoresha ya the igikoresho

2.1.  Yagenewe intego

Sisitemu yo gutunganya inkoni yinyuma irimo urukurikirane. Sisitemu yo gukosora igamije guteza imbere guhuza urutirimbi rwa crosical na octopito-cyuma-thocic-thotic (octiput-t3). Sisitemu yo gutunganya inkoni yinyuma igizwe nuburyo butandukanye bwisahani, inkoni, kwambukiranya (guhuza isahani), imiyoboro, ihungabana, gufatanya, gushiraho.

2.2.  Kwerekana (s) na intego abaturage (s)

Ibimenyetso:

• Indwara ya Degenerative (DDD) (Ububabare bw'Ijosi ry'inkomoko hamwe no kwangirika kuri disiki nkuko byemejwe n'amateka y'abarwayi n'ubushakashatsi bwa radiyo);

2) Spondylolisthesis;

3) iterahamwe ry'umugongo;

4) kuvunika / kwimyambaza;

5) kuvunika / gutondama hamwe no guhungabana;

6) Kwiyubaka;

7) Gusubiramo kubaga umugongo byabanjirije;

8) Ibibyimba

2.3.  Kumenyekanisha na / cyangwa Imipaka

Kumenyekanisha birimo, ariko ntibigarukira kuri:

Guhitamo ingano ikwiye, imiterere nigishushanyo mpimbano kuri buri murwayi ningirakamaro kugirango bitsinde. Ibikurikira byo kurutonde rwibintu bibi birimo:

1. Inzira ikora cyangwa ibyago bikomeye byo kwandura (imyumecompromise).
2. Ibimenyetso byo gutwika kwaho.
3. Umuriro cyangwa leukocytose.
4. Umubyibuho ukabije.
6. Uburwayi bwo mu mutwe.
7. Bikabije bigoreka anatomy biterwa na kavuni bidasanzwe.
8. Undi muntu uwo ari we wese wabikuye ku buvuzi cyangwa kubaga byabuzaga inyungu zo kubagwa ku gateganyo, ku buroko buhebuje n'izindi ndwara zidasobanuwe n'izindi raso.
9. Ukekwaho cyangwa yanditseho allergie y'icyuma cyangwa kutoroherana.
10. Urubanza urwo arirwo rwose rudakeneye amagufwa no guswera.
11. Urubanza urwo arirwo rwose aho ibice bigize ibikorwa byatoranijwe kugirango bikoreshwe cyane cyangwa bito cyane kugirango tugere kubisubizo byatsinze.
12. Umurwayi uwo ari we wese ufite tissue idahagije kurubuga rwakazi cyangwa ububiko budahagije cyangwa ubuziranenge.
13. Umurwayi uwo ari we wese uhuza ko uzabangamira inzego za anatomicake cyangwa ziteganijwe ku mubiri.
14. Umurwayi uwo ari we wese adashaka gukurikiza amabwiriza yo gutangwa.

Urubanza 15. rutarasobanurwa mubimenyetso.

3. Ibisobanuro

3.1.  Ibisobanuro ya the igikoresho

Sisitemu yo gutunganya inkoni yinyuma irimo urukurikirane. Sisitemu yo gukosora igamije guteza imbere guhuza urutirimbiro c'urutirimbi rw'inkondo y'umura na choterico-thoiput.

Ibikoresho bitangwa mubitari sterile. Irasabwa kugandukira ukoresheje uburyo bwitoze kugirango ugere ku sal ya 10-6 n'ibitaro mbere yo kubagwa. Uburyo bwa Sterilisation yasabwe yemejwe kuri isoko ya ISO 17665-1: 2006 Gusukura ibicuruzwa byubuzima - ubushyuhe bwo kwivuza - Igice cya 1: Ibisabwa mu Iterambere, Kwemeza, no kugenzura gahunda yo guhonyora ibikoresho byubuvuzi.

3.2.  A Reba Kuri mbere Igisekuru cyangwa impinduka Niba gutya kubaho, na a ibisobanuro ya the itandukaniro

Ntibikurikizwa. Nta gisekuru cyabanje.

3.3.  Ibisobanuro ya icyaricyo cyose ibikoresho aribyo ni yagenewe Kuri be Byakoreshejwe in guhuza hamwe the igikoresho

Ntibikurikizwa. Nta bakozi kuri iki gikoresho.

3.4.  Ibisobanuro ya icyaricyo cyose ikindi ibikoresho na ibicuruzwa aribyo ni yagenewe Kuri be Byakoreshejwe Guhuza nigikoresho

Ntibikurikizwa. Igikoresho ntabwo kigenewe gukoreshwa muguhuza nibindi bikoresho nibicuruzwa.

4. 4. Ingarukana Umuburo

4.1.  Isigaye Ingaruka na Utifuzwa Ingaruka

Isesengura ryuzuye ryibibazo byose bisigaye byakozwe nitsinda risubiramo. Urebye ingaruka zifatika zingaruka zose zisigaye, umwanzuro wanyuma washushanijwe ko ibicuruzwa byuzuye bisigaye bishobora kwemerwa. Isuzuma rirambuye ryashyizwe ku rutonde rukurikira:

1) Ese ibyago ku giti cyabo bigenzura mu kwivuguruza?

Umwanzuro: Nta tegeko rishinzwe kurwanya ibyago nyamara ryabonetse mubyiyumvo.

2) Gusubiramo amabwiriza (E.G. Hoba hariho ibisobanuro bivuguruzanya? Hoba hariho itegeko rigoye gukurikiza?)

Umwanzuro: Amabwiriza y'ibicuruzwa yubahiriza ibisabwa n'amabwiriza afitanye isano. Ibisobanuro bijyanye nibicuruzwa birasobanutse kandi byoroshye kubyumva.

3) Kugereranya nibicuruzwa bisa

Umwanzuro: Ugereranije nibikoresho bisa ku isoko mu ivuriro, imiterere n'imikorere. Ibicuruzwa bikora bisa nibikoresho. Kubwibyo bacirwa urubanza kugira imitungo yagereranijwe kuri iki gikoresho.

• Umwanzuro Witsinda ryo gusuzuma

Umwanzuro: Umwanzuro wanyuma wagezweho binyuze mumasuzuma yavuzwe haruguru ko ibicuruzwa byuzuye bishobora kwemerwa.

4.2.  Umuburo na ingamba

Umuburo:

Umutekano ningirakamaro kuri pedicle screw sisitemu yumugongo yashizweho gusa kumiterere yumugongo hamwe nubutaka bukomeye cyangwa ubumuga busaba guhuzagurika hamwe nigikoresho. Ibi bintu birakomeye cyane byubuka neza cyangwa ubumuga bwisumbuye, LUBARARY, N'UMURIMO, GUKURIKIRA, KYHOLIOSIS, KYHOLIOSISIP, HYPHOLIOSISIP YAKORESHEJWE (PSEUADHROSIS). Umutekano nuburyo bukora kuri iki gikoresho kubindi bintu byose ntibizwi. Gutera ntabwo ari prostate. Mugihe udahari, igikoresho na / cyangwa kimwe cyangwa byinshi mubigize bimwe bishobora gutegurwa gukuramo, kunama cyangwa kuvunika biturutse kumihangayiko yiminsi mibi.

Ingamba：

1. Umuganga ubaga agomba kuba afite ubuhanga bwo gukora ibikoresho no gukangurira, uburambe bwiza mu kubaga umugongo;
2. Muganga akwiye gusuzuma umurwayi mbere yo kubagwa, kandi acire urubanza niba akwiriye gukoresha ibihano akurikije uburemere bwumurwayi, umwuga, habaho ubukana bwa allergic mu mubiri w'amahanga, ndetse n'indwara; Ibisobanuro byicyitegererezo bikurikizwa bigomba gutorwa ukurikije uko umurwayi ameze. Mbere yo gukora, gushikama ubwoko butandukanye nibisobanuro bigomba gutegurwa, kandi kubaga ntibigomba gukorwa nta ngwate zihagije zabaganzirizaga;
3. Niba imbaraga zacitse, zimuwe, zivuza, zirekuye, kwandura cyangwa gutakaza amagufwa, imbaraga zigomba gusuzumwa kugirango zikure.
4. Seclant ntishobora gutunganywa cyangwa guhindurwa muburyo ubwo aribwo bwose usibye uko byemewe nigishushanyo mbonera kandi nkuko bigaragara mu gitabo cya tekiniki. Irinde gukosora, kunama, gukata cyangwa gushushanya imbaraga kugirango wirinde kunanirwa.
5. Abarwayi bagomba gukora ibikorwa bibuza nyuma yubuyobozi buyobowe na muganga kugirango babuze kunanirwa kwibicuruzwa nibibazo biterwa nibikorwa birenze urugero nyuma yo kubaga.
6. Abarwayi nimiryango yabo bagomba kumenya ingorane zanyuma hamwe ningaruka zishoboka.
7. Itariki yo kurangiriraho iki gicuruzwa: umwaka umwe nyuma yo gutera imibiri yumuntu cyangwa nkuko byayobowe na muganga.

4.3.  Ikindi bijyanye ibintu ya umutekano, harimo a Incamake ya icyaricyo cyose umurima umutekano gukosora ibikorwa (Fsca harimo Fsn) Niba birashoboka

Ntibikurikizwa