Ibice bitanu byingenzi kugirango uhitemo imikorere-yo hejuru ya CMF yo kwikorera imashini

2. Kuringaniza Ingano Urwego - Guhuza n'imihindagurikire y'ikirere

Igikoresho cyiza cyane cya CMF cyo kwikorera imashini igomba gutanga ibipimo bitandukanye bya diametre hamwe nuburebure kugirango bikemure ibikenewe bitandukanye byo kubaga. Kurugero, imigozi migufi (mm 4-6 mm) ikoreshwa kenshi mubice byamagufwa yoroheje, mugihe imigozi miremire (kugeza kuri mm 14) irashobora gukenerwa kumagufa maremare cyangwa manini yubaka.

Guhindura imiterere ya screw bigabanya gukenera ibicuruzwa byinshi kandi bigabanya gutinda kubaga. Ipaki nziza igomba kuba yanditseho ibipimo byerekana ubunini, bigafasha abaganga guhitamo umugozi wiburyo byihuse bitabangamiye akazi. Byongeye kandi, igishushanyo mbonera kigomba kwemeza ubushobozi bwo kwikorera buri gihe, bikagabanya ibikenerwa mbere yo gucukura mu bihe byinshi, bishobora kubika umwanya w'agaciro mu cyumba cyo gukoreramo.

 

3. Kuvura Ubuso - Kuzamura Amagufwa no Gukora

Kurangiza hejuru ya CMF bigira uruhare runini mubikorwa byubukanishi no gusubiza ibinyabuzima. Amapaki yo mu rwego rwo hejuru ya CMF yikorera paki yamashanyarazi akenshi agaragara hejuru ya anodize cyangwa isize.

Anodisiyasi yongerera umubyimba wa okiside yubuso, itezimbere kurwanya ruswa no kongera osteointegration mugukora ubuso bwa bioactive butera amagufwa kwizirika.

Kuringaniza bigabanya amakosa ya microscopique, kugabanya bagiteri no kugabanya ibyago byo kwandura nyuma yibikorwa.

Ibicuruzwa bimwe byateye imbere birashobora guhuza ubuso bugaragara kugirango habeho ituze ryambere hamwe na anodisiyasi yigihe kirekire cyibinyabuzima. Mugihe usuzumye paki yamashanyarazi, suzuma ibicuruzwa byakozwe hejuru yubuvuzi hamwe namakuru yose yapimwe yubuvuzi.

 

4. Gupakira Sterile - Kubahiriza Ibipimo Byumba Byumba

Ndetse na screw yo mu rwego rwohejuru irabangamiwe niba ibipfunyika byananiwe kubahiriza ibisabwa. Igikoresho cyo hejuru cya CMF cyo kwipakurura kigomba gutangwa muburyo bwihariye, sterile, kandi byoroshye gufungura bipakira bihuza na protocole yicyumba cyo gukoreramo.

Shakisha paki ziranga:

Inzitizi ebyiri zidafite ishingiro zo kongera uburinzi

Byerekanwe neza amatariki yo kurangiriraho nimibare myinshi yo gukurikirana

Umukoresha-ushushanya ibishushanyo byemerera kugarura byihuse utiriwe urenga tekinike ya sterile

Bamwe mubakora uruganda batanga kandi biteguye-gukoresha-sterile tray itunganya imigozi nabashoferi muburyo bwumvikana, byoroshya inzira yo kubaga.

 

5. Kubahiriza amabwiriza - CE, FDA, na ISO 13485 Icyemezo

Mu nganda zikoreshwa mubuvuzi, impamyabumenyi zirenze impapuro - ni gihamya yubuziranenge n'umutekano bihoraho. Porogaramu yizewe ya CMF yo kwikorera imashini igomba kuba yujuje ubuziranenge mpuzamahanga nka:

Ikimenyetso cya CE - Birasabwa gukwirakwizwa mu Muryango w’ubumwe bw’ibihugu by’Uburayi, byemeza ko byubahiriza amabwiriza y’ibikoresho by’ubuvuzi by’Uburayi (MDR).

FDA yemewe - Yemeza ko ibicuruzwa byujuje umutekano nibisabwa muri Amerika.

Icyemezo cya ISO 13485 - Yerekana ko sisitemu yo gucunga neza uwabikoze yagenewe ibikoresho byubuvuzi.

Kugura kubatanga ibyemezo byemewe ntabwo byizeza gusa ibicuruzwa byizewe ahubwo binagabanya ingaruka zemewe n'amategeko no kubahiriza ibitaro n'amavuriro.

 

Mubuvuzi bwa Shuangyang, ntabwo turi abatanga isoko gusa ahubwo tunakora uruganda rwa 1.5 mm ya CMF yo kwikorera imashini. Byakozwe kandi bikorerwa mu nzu, imigozi yacu ikozwe muri premium Ti-6Al-4V yo mu rwego rwo kwa muganga ya titanium ivanze kandi ikozwe hifashishijwe ikoranabuhanga rya TONRNOS CNC ryateye imbere mu buryo budasobanutse kandi buhoraho. Hamwe no kuvura anodize, uburyo bwinshi bwo guhitamo, gupakira sterile, no kubahiriza byuzuye ibipimo bya CE, FDA, na ISO 13485, ibicuruzwa byacu byubatswe kugirango byuzuze ibisabwa cyane byo kubaga.

Gufatanya natwe bisobanura gukorana neza nisoko - kwemeza ibiciro byapiganwa, gutanga isoko ihamye, hamwe nubwiza budahwitse kubyo ukeneye kubaga CMF.