I-XC Medico
Clinical Academy

Zonke izifakelo ze-XC Medico metallic (Titanium Ti-6Al-4V kanye ne-316L Stainless Steel) zihambisana ne -steam autoclave sterilization ku- 134°C / 273°F ubuncane bemizuzu engu-18 (umjikelezo wangaphambi kwe-vacuum). Emakhejini e-PEEK interbody, sebenzisa u-134°C imizuzu emi-4 ngaphambi kwe-vacuum. Amathreyi wezinsimbi kufanele asongwe ngezikhwama ezisetshenziswa kanye. Ukuvalwa inzalo kwe-EtO (ethylene oxide) kokuthi ≤55°C kuphinde kuvunywe izingxenye ezingezwani nokushisa. Ungasebenzisi uketshezi lokuvala inzalo ngamakhemikhali/okubandayo njengoba lokhu kungonakalisa ukumbozwa kwendawo. I-IFU Egcwele (Imiyalo Yokusetshenziswa) enemininingwane yezinqubo zokuvala inzalo ifakiwe kuwo wonke amaphakheji omkhiqizo.

I-XC Medico isebenzisa i-Ti-6Al-4V ELI (I-Interstitial Extra-Low) IBanga lesi-23 nge-ASTM F136 ngayinye, izinga lebanga lezokwelapha. Izakhiwo ezibalulekile: Amandla aqinile ≥860 MPa , amandla esivuno ≥795 MPa, elongation ≥10%. Ukwakhiwa kwe-alloy yi-90% Titanium, 6% Aluminium, 4% Vanadium. Amapuleti amathambo nezikulufu zithola ukwelashwa kwendawo ye -anodization yohlobo lwe-II ukuze kuthuthukiswe ukumelana nokugqwala kanye nokuhlanganiswa kwe-osseo. Le alloy ine-MRI-condition at 1.5T kanye ne-3T enemibandela ethile yokuskena enemininingwane ekulebulani komkhiqizo.

Zonke izimila ezisekelwe ku-Titanium ze-XC Medico zihlukaniswa njenge -MR Conditional nge-ASTM F2503 ngayinye. Aphephile ku -1.5T naku-3.0T amandla enkambu ene-gradient yendawo engu-720 G/cm. Izimila zensimbi engagqwali (316L) nazo ziyi-MR Conditional kodwa zingadala ama-artifact esithombe amakhulu; ukuxhumana ne-radiologist. Ungenzi i-MRI phakathi kwamaviki angu-6 okufakelwa ngaphandle uma uphuthuma ngokomtholampilo. Specific SAR (Specific Absorption Rate) imikhawulo kanye nemikhawulo yokubeka indawo inikeziwe emibhalweni ye-IFU yomkhiqizo ngamunye etholakala Esikhungweni Sezinsiza ngenhla.

Ama-torque okugcina anconyiwe okuqinisa ayahlukahluka ngobubanzi obuyizikulufu: 3.5mm izikulufu zekhortical: 1.2–1.5 Nm , 4.5mm izikulufu zecortical: 2.0–2.5 Nm , 5.0mm izikulufu zokukhiya: 2.8–3.2 Nm , 6.5mm izikulufo zokukhansela: 3.5-0.0 . Ngaso sonke isikhathi sebenzisa isikrudrayiva esikhawulela itorque esilinganiselwe futhi ungalokothi weqe itorque enkulu ukuze ugweme ukukhumula indlela yokukhiya noma i-welding ebandayo. Uma ukuphikiswa mathupha kuzwakala ngesikhathi sokufaka ngaphambi kokufinyelela ekujuleni kokugcina, yima futhi uqinisekise ububanzi bembobo yombhobo ngomkhono olungile womhlahlandlela wokubhoboza. Izikulufu zokukhiya ezihlutshiwe zidinga ikhithi ekhethekile yokususa etholakala ngokuhlukene.

Izimila ze-XC Medico ezifakwe emaphaketheni angenalutho zineshalofu leminyaka engu-5 kusukela ngedethi yokukhiqiza (bona ilebula). Izimo zesitoreji: izinga lokushisa elingu- +5°C kuya ku-+30°C , umswakama ohlobene no-15-85% ongajiki , kude nelanga eliqondile namakhemikhali abolayo. Noma yimaphi amaphakheji abonisa ama-punctures, umswakama, noma ukulimala kokucindezelwa kufanele kubekwe yedwa futhi kungasetshenziswa. I-PEEK kanye nezingxenye ezisebenzisekayo zingase zibe nokuphila kweshalofu okufushane (imvamisa iminyaka emi-3) — hlala uhlola ilebula yomkhiqizo ngamunye. Amarekhodi okulandeleka (inombolo yesabelo, ukuphela kwesikhathi, ukusetshenziswa kwesiguli) kufanele agcinwe ngokwemithetho yendawo ye-MDR.

I-XC Medico iphethe izitifiketi ezilandelayo: ISO 13485:2016 (Quality Management System), CE Marking ngaphansi kwe-EU MDR 2017/745 (Class IIb), kanye nokubhaliswa kwe-CFDA/NMPA yemakethe yaseShayina. Imikhiqizo ehloselwe izimakethe ezithile ingase iphathe izimvume ezengeziwe zasendaweni - thintana noxhumana nabo besifunda. Ozakwethu be-OEM bangase bacele imibiko yocwaningo kanye nemibhalo Yesimemezelo Sokuvumelana eqenjini lethu Lezindaba Zokulawula. Okwamanje asinayo imvume ye-FDA 510(k) yemakethe yase-US; sicela uqinisekise ukufaneleka kwemakethe ngaphambi kokufaka ama-oda okufakwa e-US.