XC
Xikolo xa Tliliniki xa Medico

Hinkwaswo switirhisiwa swa nsimbi swa XC Medico (Titanium Ti-6Al-4V na 316L Stainless Steel) swi fambisana na steam autoclave sterilization eka 134°C / 273°F kuringana kwalomu ka 18 wa timinete (pre-vacuum cycle). Eka ti PEEK interbody cages, tirhisa 134°C kuringana 4 wa timinete pre-vacuum. Titreyi ta switirhisiwa tifanele ku phutseriwe eka swikhwama leswi tirhisiwaka kan’we. EtO (ethylene oxide) sterilization eka ≤55°C yitlhela yi pfumeleriwa eka swiphemu leswi twaka ku hisa. Unga tirhisi ti khemikhali/cold sterilization liquids tani hileswi leswi swinga onhaka swifunengeto swale henhla. IFU leyi heleleke (Swiletelo swa Matirhiselo) leyi hlamuselaka vuxokoxoko bya ti protocol ta sterilization yi katsiwile eka ku pakiwa kun’wana na kun’wana ka xiendliwa.

XC Medico yi tirhisa Ti-6Al-4V ELI (Extra-Low Interstitial) Giredi ya 23 hi ASTM F136, mpimanyeto wa giredi ya swa vutshunguri. Swihlawulekisi swa nkoka: Matimba ya ku tsana ≥860 MPa , matimba ya mbuyelo ≥795 MPa, ku leha ≥10%. Xivumbeko xa alloy i 90% Titanium, 6% Aluminium, 4% Vanadium. Ti bone plates nati screws swiendliwa eka Type II anodization surface treatment kuva ku ndlandlamuxa ku tiya ka corrosion xikan’we na osseointegration. Alloy leyi yina MRI-conditional eka 1.5T na 3T na swiyimo swokarhi swa scan leswi hlamuseriweke hi vuxokoxoko eka ku lebula ka xiendliwa.

Ti implants hinkwato ta XC Medico leti simekiweke eka Titanium ti hlayiwa tani hi MR Conditional hi ASTM F2503. Ti hlayisekile eka 1.5T na 3.0T ya matimba ya nsimu na nhlayo yale henhla ya spatial gradient ya 720 G/cm. Ti implants ta stainless steel (316L) na tona i MR Conditional kambe tinga vanga switirhisiwa leswikulu swa swifaniso; ku fambisana na dokodela wa radiology. U nga endli MRI ku nga si hela 6 wa mavhiki endzhaku ka ku vekiwa handle ka loko swi ri swa xihatla hi tlhelo ra tliliniki. Swipimelo swo karhi swa SAR (Specific Absorption Rate) na swipimelo swa ku vekiwa swi nyikiwile eka matsalwa ya IFU ya xiendliwa xin’wana na xin’wana lama kumekaka eka Senthara ya Switirhisiwa laha henhla.

Ti torque to hetelela leti ringanyetiweke to tiyisisa ti hambana hi diameter ya swikwirikiri: 3.5mm swikwirikiri swa cortical: 1.2–1.5 Nm , 4.5mm swikwirikiri swa cortical: 2.0–2.5 Nm , Swikwirikiri swo pfala swa 5.0mm: 2.8–3.2 Nm , 6.5mm swikwirikiri swa cancellous: 3.5–4.0 Nm . Minkarhi hinkwayo tirhisa screwdriver leyi calibrated torque-limiting naswona unga tshuki u tlula torque leyikulu kuva u papalata ku hluvula muchini wo pfala kumbe ku cold-welding. Loko ku lwisana ka manual ku twiwa hinkarhi wa ku nghenisiwa loko unga se fika eka vuenti byohetelela, yima u tiyisisa diameter ya hole ya drill hi sleeve ya drill guide leyinene. Ti screws to pfala leti hluvuriweke ti lava xitirhisiwa xo hlawuleka xo susa lexi kumekaka hiku hambana.

Ti implants ta XC Medico eka ti intact sterile packaging tina vutomi bya shelf bya 5 wa malembe kusukela hi siku ro endliwa (vona lebula). Swiyimo swa vuhlayiselo: mahiselo +5°C kuya eka +30°C , kutsakama loku ringanaka 15–85% non-condensing , ekule na ku vonakala ka dyambu hiku kongoma na tikhemikhali leti onhaka. Ku pakiwa kwihi na kwihi loku kombisaka ku tlhaviwa, kutsakama, kumbe ku onhaka ka ntshikelelo swifanele ku vekiwa ekule naswona swinga tirhisiwi. PEEK na swiphemu leswinga resorbable swinga va na vutomi byo koma bya shelf (hi ntolovelo 3 wa malembe) — minkarhi hinkwayo languta lebula ya xiendliwa xin’wana na xin’wana. Tirhekhodo ta ku landzelerisa (nomboro ya lot, ku hela ka nkarhi, ku tirhisiwa ka muvabyi) ti fanele ku hlayisiwa hi ku landza milawu ya MDR ya ndhawu.

XC Medico yi khome switifikheti leswi landzelaka: ISO 13485:2016 (Sisiteme ya Vulawuri bya Khwalithi), CE Marking ehansi ka EU MDR 2017/745 (Tlilasi IIb), na ku tsarisiwa ka CFDA / NMPA eka makete wa China. Swikumiwa leswi kongomisiweke eka timakete to karhi swi nga ha rhwala mpfumelelo wo engetela wa laha kaya — vulavurisana na vuhlanganisi bya wena bya vuxavisi bya xifundzha. Vatirhisani va OEM va nga ha kombela swiviko swa oditi na matsalwa ya Xitiviso xa ku Fambisana eka ntlawa wa hina wa Timhaka ta Vulawuri. Sweswi a hi khomi mpfumelelo wa FDA 510(k) wa makete wa le United States; hi kombela u tiyisisa ku faneleka ka makete u nga si endla tioda ta nhundzu leyi yaka eUS.