Ndi Chidule Chotani Chokhudza Chitetezo ndi Ntchito Zachipatala? - ZhongXing

Chidule Chachidule cha Chitetezo ndi Clinical Performance (SSCP) cholinga chake ndikupereka mwayi kwa anthu kuti amve chidule chosinthidwa cha mbali zazikulu zachitetezo ndi machitidwe azachipatala a chipangizocho.

SSCP sinapangidwe kuti ilowe m'malo mwa Malangizo Ogwiritsa Ntchito ngati chikalata chachikulu chowonetsetsa kuti chipangizocho chikugwiritsidwa ntchito moyenera, komanso sichinapangidwe kuti chipereke malingaliro ozindikira kapena achire kwa omwe akufuna kugwiritsa ntchito kapena odwala.

Izi ndizomwe zimapangidwira ogwiritsa ntchito / akatswiri azaumoyo.

Ngati SSCP ikuphatikizapo odwala, zotsatirazi zikhoza kuwonjezeredwa: Kutsatira chidziwitso ichi pali chidule chomwe chimapangidwira odwala.

1. 1. Chipangizochizindikiritso ndi wamba zambiri
2. 1. Dzina logulitsira chipangizo (ma)

Dongosolo la posterior cervical fixation

1.2.  Dzina ndi adilesi ya wopanga

Dzina la wopanga:Beijing Chunlizhengda Medical Instruments Co., Ltd. Manufacturer adilesi:No. 10 Xinmi West 2nd Road, South Region of  Tongzhou Economic Development Zone, Tongzhou District, Beijing, 101112, China

1.3.  Nambala yolembetsa imodzi yakupanga (SRN)

SRN: CN-MF-000019514

1.4.  Basic-UDI-DI

Chonde onani 22-CL-CE-2-001-0004 Basic-UDI-DI ya Posterior cervical fixation system.

1.5.  Kufotokozera / zolemba za chipangizo chachipatala

EMDN kodi ndi kufotokozera

Kodi P09070301

Nthawi yovomerezeka   SPINE STABILIZATION PROSTHESES AND SYSTEMS

1.6.  Kalasi ya chipangizo

Kalasi IIb, malinga ndi Annex VIII ya MDR.

1.7.  Chaka pomwe satifiketi yoyamba (CE) idaperekedwa kuphimba chipangizocho

Chunlizhengda adalandira chizindikiro cha CE cha kachitidwe ka khomo lachiberekero pansi pa Directive 93/42/EEC mchaka cha 2020.

1.8.  Woyimira wovomerezeka ngati akuyenera; dzina ndi SRN

Dzina: MedNet EC-REP C III GmbH

SRN: DE-AR-000011196

1.9.  Dzina la NB (NB yomwe idzatsimikizire SSCP) ndi nambala imodzi yozindikiritsa ya NB

Dzina: TÜV SÜD Product Service GmbH

Nambala ya Chizindikiritso: 0123

2. 2. Zolingantchito za ndi chipangizo

2.1.  Zolinga cholinga

The Posterior Cervical Fixation System ili ndi magawo awiri. Dongosolo lokonzekera limapangidwira kulimbikitsa kusakanikirana kwa msana wa khomo lachiberekero ndi occipito-cervico-thoracic junction (occiput-T3). The Posterior Cervical Fixation System imakhala ndi mawonekedwe osiyanasiyana ndi kukula kwa mbale, ndodo, crosslink (Cholumikizira Cholumikizira / Cholumikizira ndowe), zomangira, mbedza, zolumikizira zam'mbali ndi zomangira.

2.2.  Zizindikiro ndi chandamale anthu

Zizindikiro:

• Degenerative disc matenda (DDD) (kupweteka kwa khosi kwa discogenic chiyambi ndi kuwonongeka kwa diski monga kutsimikiziridwa ndi mbiri ya odwala ndi maphunziro a radiographic);

2) Spondylolisthesis;

3) stenosis ya msana;

4) Kusweka / kusuntha;

5) Atlanto / axial fracture ndi kusakhazikika;

6) Occipitocervical dislocation;

7) Kukonzanso kwa opaleshoni yam'mbuyo yamsana;

8) Zotupa

2.3.  Contraindications ndi/kapena malire

Contraindications ikuphatikizapo, koma sikungowonjezera ku:

Kusankhidwa kwa kukula koyenera, mawonekedwe ndi mapangidwe a implants kwa wodwala aliyense ndizofunikira kwambiri kuti ntchitoyi ikhale yopambana. Zotsatira zoyipa zomwe zingakhalepo zikuphatikizapo:

1. Njira yogwira ntchito yopatsirana kapena chiopsezo chachikulu cha matenda (immunocompromise).
2. Zizindikiro za kutupa kwanuko.
3. Leukocytosis kapena malungo.
4. Kunenepa kwambiri.
6. Matenda a maganizo.
7. Kusokonezeka kwakukulu kwa anatomy chifukwa cha zovuta zobadwa nazo.
8. Matenda ena aliwonse kapena opaleshoni omwe angalepheretse kupindula kwa opaleshoni ya msana, monga kukhalapo kwa matenda obadwa nawo, kukwera kwa sedimentation mlingo wosadziwika ndi matenda ena, kukwera kwa magazi oyera (WBC), kapena kusintha kwamanzere kumanzere kwa chiwerengero cha WBC chosiyana.
9. Kuganiziridwa kapena zolembedwa zitsulo ziwengo kapena tsankho.
10. Mlandu uliwonse wosafunikira kumezanitsa mafupa ndi kuphatikizika.
11. Nthawi iliyonse yomwe zida zopangira zosankhidwa kuti zigwiritsidwe ntchito zitha kukhala zazikulu kapena zazing'ono kwambiri kuti zitheke kukwaniritsa zotsatira zabwino.
12. Wodwala aliyense yemwe ali ndi minofu yosakwanira pamalo opangira opaleshoniyo kapena mafupa osakwanira kapena mtundu wake.
13. Wodwala aliyense yemwe kuyika kwake kumasokoneza magwiridwe antchito a thupi kapena momwe thupi limagwirira ntchito.
14. Wodwala aliyense wosafuna kutsatira malangizo a pambuyo opaleshoni.

15.Mlandu uliwonse womwe sunafotokozedwe muzowonetsa.

3. Kufotokozera kwachipangizo

3.1.  Kufotokozera za ndi chipangizo

The Posterior Cervical Fixation System ili ndi magawo awiri. Kukonzekera kwadongosolo kumapangidwira kulimbikitsa kuphatikizika kwa msana wa khomo lachiberekero ndi occipito-cervico-thoracic junction (occiput-T3), yomwe imagwiritsidwa ntchito kukonza vertebrae yapambuyo ya chiberekero cha odwala.

Zipangizozi zimaperekedwa m'malo osabala. Imafunika kutsekeredwa kudzera munjira ya autoclave kuti mufikire SAL ya 10-6 ndi chipatala opaleshoni isanachitike. Njira yovomerezeka yotseketsa inatsimikiziridwa malinga ndi ISO 17665-1:2006 Kutseketsa kwa zinthu zachipatala -- Kutentha kwachinyontho-Gawo 1: Zofunika pakukonza, kutsimikizira, ndi kuwongolera mwachizolowezi njira yotseketsa pazida zachipatala.

3.2.  A umboni ku zam'mbuyo m'badwo kapena zosiyanasiyana ngati zotere kukhalapo, ndi a kufotokoza za ndi kusiyana

Zosafunika. Palibe m'badwo wakale.

3.3.  Kufotokozera za iliyonse zowonjezera amene ndi anafuna ku kukhala ntchito mu kuphatikiza ndi ndi chipangizo

Zosafunika. Palibe zowonjezera pa chipangizochi.

3.4.  Kufotokozera za iliyonse zina zipangizo ndi mankhwala amene ndi anafuna ku kukhala ntchito kuphatikiza ndi chipangizo

Zosafunika. Chipangizo sichimagwiritsidwa ntchito limodzi ndi zida ndi zinthu zina.

4. 4. Zowopsandi Machenjezo

4.1.  Zotsalira zoopsa ndi osafunika zotsatira

Kusanthula mwatsatanetsatane za zoopsa zonse zotsalira zachitidwa ndi gulu lowunika. Poganizira zophatikizika zowopsa zotsalira, mfundo yomaliza  imasonyeza kuti  chiwopsezo chotsalira cha mankhwala chikhoza kuvomerezedwa. Kuwunika kwatsatanetsatane kwalembedwa motere:

1)   Kodi njira zoyendetsera chiwopsezo cha munthu aliyense zikusemphana?

Kutsiliza: Palibe zowongolera zoopsa zomwe zapezekabe zotsutsana.

2)    Unikaninso malangizo (monga pali malongosoledwe aliwonse otsutsana? Kodi pali lamulo lovuta kutsatira?)

Kutsiliza: Malangizo azogulitsa amagwirizana ndi zofunikira zokhudzana ndi malamulo. Mafotokozedwe okhudzana ndi malonda ndi omveka bwino komanso osavuta kumva.

3)    Poyerekeza ndi zinthu zofanana

Kutsiliza: Poyerekeza ndi zida zofananira pamsika pazachipatala, katundu ndi magwiridwe antchito. Zomwe zimapangidwira ndizofanana ndi zida izi. Chifukwa chake amawerengedwa kuti ali ndi zinthu zofananira ndi zida izi.

• Kumaliza kwa gulu lowunika

Kutsiliza: Mapeto omaliza afikiridwa kudzera m'mawunidwe omwe ali pamwambawa kuti chiwopsezo chotsalira cha mankhwala chikhoza kuvomerezedwa.

4.2.  Machenjezo ndi kusamalitsa

Machenjezo:

Chitetezo ndi mphamvu ya pedicle screw spinal systems zakhazikitsidwa pokhapokha pazikhalidwe za msana ndi kusakhazikika kwakukulu kwa makina kapena kupunduka komwe kumafunikira kusakanikirana ndi zida. Izi ndizosakhazikika bwino zamakina kapena kupunduka kwa thoracic, lumbar, ndi sacral spine yachiwiri kupita ku spondylolisthesis yowonongeka ndi umboni wotsimikizirika wa kuwonongeka kwa ubongo, kupasuka, kusokonezeka, scoliosis, kyphosis, chotupa cha msana, ndi kulephera kuphatikizika koyambirira (pseudarthrosis). Chitetezo ndi mphamvu ya chipangizochi pazinthu zina zilizonse sizidziwika. Ma implants si ma prostheses. Pakapanda kusakanikirana, chida ndi/kapena chimodzi kapena zingapo za zigawo zake zitha kuyembekezera kutulutsa, kupindika kapena kusweka chifukwa chokumana ndi zovuta zamakina tsiku lililonse.

Kusamalitsa：

1. Dokotala wa opaleshoni ayenera kukhala waluso pakugwiritsa ntchito zida ndi implants, chidziwitso chabwino pakuchita opaleshoni ya msana;
2. Dokotala ayenera kuyesa wodwalayo asanamuchite opaleshoni, ndikuweruza ngati kuli koyenera kugwiritsa ntchito implants molingana ndi kulemera kwa wodwalayo, ntchito yake, kuchuluka kwa ntchito, momwe amaganizira, ngati akudwala thupi lachilendo, komanso momwe amakhalira matendawa; zofunikira zachitsanzo ziyenera kusankhidwa malinga ndi momwe wodwalayo alili. Opaleshoni isanachitike, ma implants amitundu yosiyanasiyana ndi mafotokozedwe amayenera kukonzedwa, ndipo opaleshoni siyenera kuchitidwa popanda kukonzekera kokwanira;
3. Ngati implants yathyoledwa, itasunthidwa, yathyoledwa, yotayika, matenda kapena mafupa, implant iyenera kuganiziridwa kuti ichotsedwe.
4. Kuyikako sikungasinthidwe kapena kusinthidwa mwanjira iliyonse kupatula ngati kuloledwa ndi mapangidwe komanso monga momwe zafotokozedwera mu bukhu laukadaulo. Pewani kukonza, kupindika, kudula kapena kukanda zoyikapo kuti zisawonongeke.
5. Odwala ayenera kuchita zinthu zoletsa pambuyo pa opaleshoni motsogozedwa ndi dokotala kuti apewe kulephera kwa mankhwala ndi zovuta zomwe zimachitika chifukwa chochita masewera olimbitsa thupi kapena kulemera kwambiri pambuyo pa opaleshoni.
6. Odwala ndi mabanja awo ayenera kudziwa za zovuta zomwe zimachitika pambuyo pa opaleshoni komanso zotsatirapo zake.
7. Tsiku lotha ntchito: chaka chimodzi pambuyo pa kuikidwa m'thupi la munthu kapena monga momwe dokotala adanenera.

4.3.  Zina zofunikira mbali za chitetezo, kuphatikizapo a mwachidule za iliyonse munda chitetezo kukonza zochita (FSCA kuphatikizapo FSN) ngati zoyenera

Zosafunika