XC Medico
Clinical Academy

Ibyuma byose bya XC Medico byatewe (Titanium Ti-6Al-4V na 316L Stainless Steel) birahujwe na sterisisation ya autoclave yamashanyarazi kuri 134 ° C / 273 ° F byibuze byibuze iminota 18 (cycle pre-vacuum). Kuri kashe ya PEEK, koresha 134 ° C muminota 4 mbere ya vacuum. Ibikoresho by'ibikoresho bigomba gupfunyika inshuro imwe. Guhindura EtO (Ethylene oxyde) kuri ≤55 ° C nabyo byemewe kubice byangiza ubushyuhe. Ntukoreshe imiti / ubukonje bwa sterilisation kuko ishobora guhungabanya hejuru yubutaka. IFU Yuzuye (Amabwiriza yo Gukoresha) arambuye protocole ya sterilisation ishyirwa mubicuruzwa byose bipfunyika.

XC Medico ikoresha Ti-6Al-4V ELI (Extra-Low Interstitial) Icyiciro cya 23 kuri ASTM F136, urwego rwubuvuzi. Ibintu byingenzi: Imbaraga zingana 60860 MPa , umusaruro utanga ≥795 MPa, kurambura ≥10%. Ibigize amavuta ni 90% Titanium, 6% Aluminium, 4% Vanadium. Isahani yamagufa hamwe ninshini zivurwa muburyo bwa II anodisiyonike kugirango zongere ruswa kandi osseointegration. Iyi mavuta ni MRI-itondekanya kuri 1.5T na 3T hamwe nuburyo bwihariye bwa scan burambuye mubirango byibicuruzwa.

Byose byatewe na Titanium XC Medico byashyizwe mubikorwa nka MR Imiterere kuri ASTM F2503. Bafite umutekano kuri 1.5T na 3.0T imbaraga zumurima hamwe nubunini ntarengwa bwa 720 G / cm. Ibyuma bidafite ibyuma (316L) nabyo ni MR Imiterere ariko irashobora gutera ibihangano binini; guhuza na radiologue. Ntugakore MRI mugihe cyibyumweru 6 nyuma yo guterwa keretse byihutirwa mubuvuzi. Imipaka yihariye ya SAR (Igipimo cyihariye cya Absorption) imipaka hamwe nimbogamizi zumwanya zitangwa mubicuruzwa byihariye IFU ibyangombwa biboneka muri Resource Centre hejuru.

Icyifuzo cya nyuma cyo gufunga itandukanyirizo gitandukana na diameter ya screw: 3.5mm ya cortical cortical: 1.2-1.5 Nm , 4.5mm ya cortical cortical: 2.0-22.5 Nm , 5.0mm yo gufunga: 2.8–3.2 Nm , 6.5mm imiyoboro ya kanseri: 3.5-4.0 Nm . Buri gihe koresha kalibibasi ya torque igabanya amashanyarazi kandi ntuzigere urenga urumuri ntarengwa kugirango wirinde kwambura uburyo bwo gufunga cyangwa gukonjesha ubukonje. Niba imbaraga zintoki zunvikana mugihe cyo gushiramo mbere yo kugera mubwimbitse bwa nyuma, hagarara hanyuma ugenzure umwobo wa diameter umwobo hamwe nuburyo bwiza bwo kuyobora imyitozo. Gufunga imigozi isaba ibikoresho byabigenewe byabigenewe bitandukanye.

XC Medico yatewe mubipfunyika bidafite sterile bifite ubuzima bwimyaka 5 uhereye igihe byakorewe (reba ikirango). Imiterere yububiko: ubushyuhe + 5 ° C kugeza kuri + 30 ° C , ubuhehere bugereranije 15-85% ntibucucike , kure yizuba ryinshi n imiti yangiza. Ibipfunyika byose byerekana imyenge, ubushuhe, cyangwa ibyangiritse byangiritse bigomba gushyirwa mu kato kandi ntibikoreshwa. PEEK nibishobora kugarurwa birashobora kugira igihe gito cyo kubaho (mubisanzwe imyaka 3) - burigihe ugenzura ibicuruzwa byihariye. Inyandiko zikurikirana (nimero nyinshi, igihe kirangiye, gukoresha abarwayi) zigomba kubungabungwa mumabwiriza ya MDR yaho.

XC Medico ifite impamyabumenyi zikurikira: ISO 13485: 2016 (Sisitemu yo gucunga ubuziranenge), CE Ikimenyetso cya EU MDR 2017/745 (Icyiciro cya IIb), hamwe na CFDA / NMPA kwiyandikisha ku isoko ry’Ubushinwa. Ibicuruzwa bigenewe amasoko yihariye birashobora gutwara ibyemezo byinyongera byaho - baza aho utuye mukarere. Abafatanyabikorwa ba OEM barashobora gusaba raporo yubugenzuzi n’itangazo ryujuje ibisabwa nitsinda ryacu rishinzwe kugenzura. Kugeza ubu ntabwo dufite FDA 510 (k) yemewe ku isoko ry’Amerika; nyamuneka wemeze kwemererwa isoko mbere yo gutanga ibicuruzwa kubarizwa muri Amerika.