XC Medico
Clinical Academy

Duk XC Medico karfe implants (Titanium Ti-6Al-4V da 316L Bakin Karfe) sun dace da tururi autoclave haifuwa a 134°C/273°F na aƙalla 18 minutes (pre-vacuum sake zagayowar). Don cages na PEEK, yi amfani da 134 ° C na minti 4 kafin a cire. Ya kamata a nannade tiren kayan aiki a cikin jakunkuna masu amfani guda ɗaya. EtO (ethylene oxide) bakara a ≤55°C kuma an yarda dashi don abubuwan da ke da zafi. Kada a yi amfani da ruwa mai sinadari/sanyi haifuwa saboda waɗannan na iya yin illa ga suturar saman. Cikakken IFU (Umarori don Amfani) yana ba da cikakken bayani game da ka'idojin haifuwa a cikin kowane marufi na samfur.

XC Medico tana amfani da Ti-6Al-4V ELI (Extra-Low Interstitial) Matsayi na 23 a kowane ASTM F136, ma'auni na likita. Key Properties: Tensile ƙarfi ≥860 MPa , yawan amfanin ƙasa ƙarfi ≥795 MPa, elongation ≥10%. Alloys abun da ke ciki shine 90% Titanium, 6% Aluminum, 4% Vanadium. Kashi faranti da sukurori sha wani nau'i na II anodization surface jiyya don bunkasa lalata juriya da osseointegration. Wannan gami shine MRI-sharadi a 1.5T da 3T tare da takamaiman yanayin duba dalla-dalla a cikin alamar samfur.

Duk tushen Titanium na tushen XC Medico an rarraba su azaman MR Conditional ta ASTM F2503. Suna da aminci a 1.5T da 3.0T ƙarfin filin tare da iyakar sararin samaniya na 720 G/cm. Bakin Karfe (316L) suma MR Sharadi ne amma yana iya haifar da manyan kayan tarihi na hoto; daidaita tare da likitan rediyo. Kada ku yi MRI a cikin makonni 6 na shigarwa sai dai idan gaggawar asibiti. Ana ba da ƙayyadaddun SAR (Takamaiman Ƙimar Ƙarfafawa) da ƙuntatawa na matsayi a cikin samfuran IFU guda ɗaya da ake samu a Cibiyar Albarkatun da ke sama.

Shawarwari na ƙarshe tightening juzu'i sun bambanta da dunƙule diamita: 3.5mm cortical sukurori: 1.2-1.5 Nm , 4.5mm cortical sukurori: 2.0-2.5 Nm , 5.0mm kulle sukurori: 2.8-3.2 Nm , 6.5mm soket: 3.5m Koyaushe yi amfani da madaidaicin juzu'i mai iyakance sukudireba kuma kada ku wuce matsakaicin juzu'i don gujewa cire na'urar kullewa ko walda mai sanyi. Idan an ji juriya da hannu yayin sakawa kafin a kai zurfin ƙarshe, tsaya kuma tabbatar da diamita na rami tare da madaidaiciyar rigar jagorar rawar soja. Sukulan kullewa suna buƙatar ƙwararrun kayan cirewa da ke akwai daban.

Abubuwan da aka saka XC Medico a cikin marufi mara kyau suna da rayuwar shiryayye na shekaru 5 daga ranar masana'anta (duba lakabin). Yanayin ajiya: zafin jiki +5°C zuwa +30°C , dangi zafi 15-85% mara sanyaya , nesa da hasken rana kai tsaye da sinadarai masu lalata. Duk wani marufi da ke nuna huda, danshi, ko lalacewa dole ne a keɓe kuma ba a yi amfani da su ba. PEEK da abubuwan da za'a iya jujjuyawa na iya samun gajeriyar rayuwar shiryayye (yawanci shekaru 3) - koyaushe bincika alamar samfurin ɗaya. Dole ne a kiyaye bayanan ganowa (lambar yawa, ƙarewa, amfani da haƙuri) ta kowace ƙa'idodin MDR na gida.

XC Medico yana riƙe da takaddun shaida masu zuwa: ISO 13485: 2016 (Tsarin Gudanar da Ingantaccen), CE Marking ƙarƙashin EU MDR 2017/745 (Class IIb), da CFDA / NMPA rajista don kasuwar Sinawa. Kayayyakin da aka ƙaddara don takamaiman kasuwanni na iya ɗaukar ƙarin yarda na gida - tuntuɓi abokin ciniki na yanki. Abokan hulɗa na OEM na iya buƙatar rahotannin tantancewa da Sanarwa Takaddun Ka'ida daga ƙungiyar Ma'aikatar Dokokin mu. A halin yanzu ba mu riƙe izinin FDA 510 (k) don kasuwar Amurka; da fatan za a tabbatar da cancantar kasuwa kafin sanya oda don ƙira na ɗaurin Amurka.