XC Medico
Clinical Academy

All XC Medico metallic implants (Titanium Ti-6Al-4V na 316L igwe anaghị agba nchara) dakọtara na uzuoku autoclave sterilization na 134°C/273°F maka opekempe nke 18 nkeji (mgbe oghere okirikiri). Maka oghere ime n'etiti PEEK, jiri 134°C mee ihe maka nkeji 4 tupu ị nweta agụụ. A ga-ejiri traịtị ngwá ọrụ n'ime obere akpa eji eme otu ihe. EtO (ethylene oxide) sterilization na ≤55°C ka akwadoro maka ihe ndị nwere mmetụta ọkụ. Ejila mmiri ọgwụ kemịkalụ/oyi sterilization n'ihi na ndị a nwere ike imebi mkpuchi elu. IFU zuru ezu (Ntuziaka maka ojiji) na-akọwapụta usoro ịgba ọgwụ mgbochi ọrịa gụnyere na nkwakọ ngwaahịa ọ bụla.

XC Medico na-eji Ti-6Al-4V ELI (Extra-Low Interstitial) ọkwa 23 kwa ASTM F136, ọkọlọtọ ọkwa ahụike. Ihe ndị dị mkpa: ike nkwụsịtụ ≥860 MPa , ike ≥795 MPa, elongation ≥10%. Ihe mejupụtara alloy bụ 90% Titanium, 6% Aluminom, 4% Vanadium. Efere ọkpụkpụ na skru na-enweta ọgwụgwọ elu ụdị II nke anodization iji kwalite nguzogide corrosion na osseointegration. Alloy a bụ MRI-conditional na 1.5T na 3T nwere ọnọdụ nyocha akọwapụtara nke ọma na ntinye aha ngwaahịa.

Ihe ntinye XC Medico niile dabere na Titanium bụ nkewa dị ka MR Conditional kwa ASTM F2503. Ha adịghị mma na ike ubi 1.5T na 3.0T nwere gradient kachasị elu nke 720 G/cm. Ihe ntinye igwe anaghị agba nchara (316L) bụkwa ọnọdụ MR mana ọ nwere ike bute ihe onyonyo buru ibu; na-ahazi na onye na-ahụ maka redio. Emela MRI n'ime izu isii nke ntinye ọ gwụla ma ngwa ngwa ụlọ ọgwụ. A na-enye oke na mmachi SAR akọwapụtara nke ọma na akwụkwọ IFU nke ọ bụla dị na ebe akụrụngwa dị n'elu.

akwadoro ikpeazụ tightening torques dịgasị iche iche site ịghasa dayameta: 3.5mm cortical kposara: 1.2-1.5 Nm , 4.5mm cortical kposara: 2.0-2.5 Nm , 5.0mm kposara kposara: 2.8-3.2 Nm , 6.5mm kagbuo: 4.5m screws . Na-eji screwdriver na-amachi oke ike mgbe niile ma ghara ịgafe oke ike ka ịzenapụsịa usoro mkpọchi ma ọ bụ ịgbado ọkụ oyi. Ọ bụrụ na a na-enwe mmetụta nguzogide akwụkwọ ntuziaka n'oge ntinye tupu eruo omimi ikpeazụ, kwụsị ma nyochaa dayameta oghere mgbawa site na iji aka nri ntụzịaka ziri ezi. skru akpọchi akpọchi chọrọ ngwa mwepụ pụrụ iche dị iche.

Ihe kụnyere XC Medico na nkwakọ ngwaahịa adịghị mma nwere ndụ shelf nke afọ 5 site na ụbọchị nrụpụta (lee akara). Ọnọdụ nchekwa: okpomọkụ +5°C ruo +30°C , iru iru mmiri 15–85% na-abụghị condensing , pụọ na ìhè anyanwụ kpọmkwem na kemịkalụ na-emebi emebi. Nkwakọ ngwaahịa ọ bụla na-egosi ntụpọ, mmiri mmiri, ma ọ bụ mkpakọ, ga-anọrọ iche ma ghara iji ya. PEEK na akụrụngwa resorbable nwere ike ịnwe ndụ shelf dị mkpụmkpụ (na-abụkarị afọ 3) - lelee akara ngwaahịa nke ọ bụla. Ekwesịrị idowe ndekọ ndekọ traceability (nọmba nza, ngwụcha, ojiji onye ọrịa) dịka iwu MDR mpaghara.

XC Medico na-ejide asambodo ndị a: ISO 13485: 2016 (Sistemụ njikwa ogo), akara CE n'okpuru EU MDR 2017/745 (Klas IIb), na ndebanye aha CFDA / NMPA maka ahịa ndị China. Ngwaahịa a kara aka maka ahịa ndị akọwapụtara nwere ike ibu nkwado mpaghara ọzọ - kpọtụrụ kọntaktị ahịa mpaghara gị. Ndị mmekọ OEM nwere ike ịrịọ mkpesa nyocha na akwụkwọ nkwupụta nkwenye n'aka ndị otu Regulatory Affairs. Anyị anaghị ejide FDA 510 (k) ikike ugbu a maka ahịa US; biko gosi ntozu ahịa tupu ịnye iwu maka ngwa ahịa ejiri US.