XC Medico
Ettendekero ly'ebyobujjanjabi

Ebyuma byonna ebya XC Medico (Titanium Ti-6Al-4V ne 316L Stainless Steel) bikwatagana n’okuzaala mu steam autoclave ku 134°C / 273°F okumala ekitono ennyo eddakiika 18 (pre-vacuum cycle). Ku PEEK interbody cages, kozesa 134°C okumala eddakiika 4 nga tonnaba kufuumuula. Ebitereke by’ebikozesebwa birina okuzingibwa mu nsawo ezikozesebwa omulundi gumu. Okuzaala EtO (ethylene oxide) ku ≤55°C nakyo kikkirizibwa ku bitundu ebiwulikika ebbugumu. Tokozesa mazzi ga chemical/cold sterilization kubanga gano gayinza okukosa ebizigo eby’okungulu. Full IFU (Instructions for Use) eraga ebikwata ku nkola z’okuzaala mu buli kintu ekipakiddwa.

XC Medico ekozesa Ti-6Al-4V ELI (Extra-Low Interstitial) Grade 23 buli ASTM F136, omutindo gw’omutindo gw’obusawo. Ebintu ebikulu: Amaanyi g’okusika ≥860 MPa , amaanyi g’amakungula ≥795 MPa, okuwanvuwa ≥10%. Ebirungo bya aloy biba 90% Titanium, 6% Aluminiyamu, 4% Vanadium. Ebipande by’amagumba ne sikulaapu biyita mu nkola ya Type II anodization surface treatment okutumbula okuziyiza okukulukuta n’okugatta amagumba. Alloy eno eriko obukwakkulizo bwa MRI ku 1.5T ne 3T nga erina embeera za sikaani ezenjawulo eziragiddwa mu bujjuvu mu kuwandiika ku bikozesebwa.

Ebintu byonna ebiteekebwa mu mubiri ebya XC Medico ebikozesebwa Titanium bibalirirwa mu kibinja kya MR Conditional okusinziira ku ASTM F2503. Zino tezirina bulabe ku maanyi g’ennimiro 1.5T ne 3.0T nga zirina ekisengejjo ekisinga obunene mu kifo kya 720 G/cm. Ebintu ebiteekebwa mu kyuma ekitali kizimbulukuse (316L) nabyo bya MR Conditional naye biyinza okuleeta ebikozesebwa ebinene eby’ebifaananyi; okukwatagana n’omusawo akola ku by’okukuba ebifaananyi. Tokola MRI mu wiiki 6 oluvannyuma lw’okusimbibwa okuggyako nga kya mangu mu bujjanjabi. Ekkomo ebitongole erya SAR (Specific Absorption Rate) n’obukwakkulizo bw’okuteeka mu kifo biweereddwa mu biwandiiko bya IFU eby’ebintu ssekinnoomu ebisangibwa mu Resource Center waggulu.

Torques ezisembayo ezisemba ez’okunyweza zaawukana okusinziira ku dayamita ya sikulaapu: Sikulufu za mm 3.5 ez’omu kisenge: 1.2–1.5 Nm , Sikulufu z’omu kisenge kya mm 4.5: , Sikulufu ezisiba mm 2.0–2.5 Nm 5.0mm: 2.8–3.2 Nm , Sikulufu ezisiba mm 6.5: 3.5–4.0 Nm . Bulijjo kozesa sikulaapu ekoma ku ttooki eriko kalifuuwa era tosukka ttooki esinga obunene okwewala okwambula enkola y’okusiba oba okuweta mu nnyonta. Singa okuziyiza okw’omu ngalo kuwulirwa mu kiseera ky’okuyingiza nga tonnatuuka ku buziba obusembayo, yimirira era okakasizza dayamita y’ekituli ky’okusima n’omukono omutuufu ogw’omulagirizi w’okusima. Sikulufu ezisiba eziggyibwako zeetaaga ekintu eky’enjawulo eky’okuggyamu ekisangibwa mu ngeri ey’enjawulo.

Ebintu ebiteekebwa mu XC Medico mu bipapula ebitaliiko kamogo biwangaala emyaka 5 okuva ku lunaku lwe byakolebwa (laba akabonero). Embeera y’okutereka: ebbugumu +5°C okutuuka ku +30°C , obunnyogovu obutuufu 15–85% obutafuuka bufuuse , wala okuva ku musana obutereevu n’eddagala erivunda. Ebipapula byonna ebiraga ebifumitiddwa, obunnyogovu oba okwonooneka mu kunyigirizibwa birina okubeera mu kalantiini so si kukozesebwa. PEEK n’ebitundu ebiddamu okuyungibwa biyinza okuba n’obulamu obutono obw’okutereka (ebiseera ebisinga emyaka 3) — bulijjo kebera ku lupapula lw’ebintu ssekinnoomu. Ebiwandiiko ebikwata ku kulondoola (ennamba ya looti, ​​okuggwaako, enkozesa y’omulwadde) birina okukuumibwa okusinziira ku mateeka ga MDR ag’omu kitundu.

XC Medico erina satifikeeti zino wammanga: ISO 13485:2016 (Enkola y’okuddukanya omutindo), CE Marking wansi wa EU MDR 2017/745 (Class IIb), n’okuwandiisa CFDA / NMPA ku katale k’e China. Ebintu ebigenda mu butale obw’enjawulo biyinza okubeera n’okukkirizibwa okulala okw’omu kitundu — weebuuze ku muntu wo ow’okutunda mu kitundu. Abakolagana ne OEM bayinza okusaba lipoota z’okubala ebitabo n’ebiwandiiko by’okulangirira okukwatagana okuva mu ttiimu yaffe evunaanyizibwa ku nsonga z’okulungamya. Mu kiseera kino tetulina FDA 510(k) clearance ku katale ka Amerika; nsaba okakasizza ebisaanyizo by'akatale nga tonnaba kuteeka order za yinvensulo ezigenda mu Amerika.