XC Medico
Clinical Academy

Yese XC Medico metallic implants (Titanium Ti-6Al-4V uye 316L Stainless Steel) inoenderana nesteam autoclave sterilization pa134 °C / 273°F kwemaminetsi mashoma gumi nemasere (pre-vacuum cycle). Pamakeji ePEEK interbody, shandisa 134°C kwemaminetsi mana pre-vacuum. Matreyi ezviridzwa anofanira kuputirwa mumapochi ekushandisa kamwe chete. EtO (ethylene oxide) sterilization pa ≤55 ° C inobvumirwawo kune zvinopisa zvinopisa. Usashandise zvinwiwa zvemakemikari/zvinotonhora nekuti izvi zvinogona kukanganisa machira epamusoro. Yakazara IFU (Mirairo Yekushandisa) inotsanangura sterillization protocol inosanganisirwa mune yega chigadzirwa kurongedza.

XC Medico inoshandisa Ti-6Al-4V ELI (Extra-Low Interstitial) Giredhi 23 paASTM F136, chiyero chekurapa-giredhi. Zvinhu zvakakosha: Kusimba simba ≥860 MPa , goho simba ≥795 MPa, elongation ≥10%. Iyo alloy kuumbwa ndeye 90% Titanium, 6% Aluminium, 4% Vanadium. Mabhonzo mahwendefa uye screws vanopinda Type II anodization pamusoro kurapwa kuti iwedzere kusaita ngura uye osseointegration. Iyi alloy ndeyeMRI-conditional pa1.5T uye 3T ine chaiwo scan mamiriro akatsanangurwa mune chigadzirwa chakanyorwa.

Zvese Titanium-based XC Medico implants inoiswa seMR Conditional paASTM F2503. Dzakachengeteka pa 1.5T uye 3.0T simba remumunda nehupamhi hwepakati pe 720 G/cm. Stainless simbi inodyara (316L) zvakare MR Conditional asi inogona kukonzera yakakura mifananidzo yakagadzirwa; kusangana neradiologist. Usaita MRI mukati memavhiki e6 ekusimwa kunze kwekunge kliniki yekukurumidzira. Specific SAR (Specific Absorption Rate) miganho uye zvirambidzo zvekumisikidza zvinopihwa muchigadzirwa chega IFU magwaro anowanikwa muResource Center pamusoro.

Torque dzekupedzisira dzinokurudzirwa dzinosiyana nedhayamita yesiruu: 3.5mm cortical screws: 1.2–1.5 Nm , 4.5mm cortical screws: 2.0–2.5 Nm , 5.0mm masiruu ekukiya: 2.8–3.2 Nm , 6.5mm 6.5mm Nm Nm 4.0 . Gara shandisa yakagadziriswa torque-inomisa screwdriver uye usambopfuura iyo yakanyanya torque kudzivirira kubvisa iyo yekukiya michina kana kutonhora-welding. Kana kuramba nemaoko kuchinzwika panguva yekupinza kusati kwasvika kudzika kwekupedzisira, mira uone dhayamita yegomba nechibooreso chakafanira. Yakabviswa yekukiya screws inoda nyanzvi yekubvisa kit inowanikwa zvakasiyana.

XC Medico maimplants ari intact sterile packaging ane hupenyu hwesherufu hwemakore mashanu kubva pazuva rekugadzira (ona label). Mamiriro ekuchengetedza: tembiricha +5 ° C kusvika +30 ° C , hunyoro hunoenderana 15-85% isingadziviriri , kure nechiedza chezuva uye makemikari anoparadza. Chero kurongedza kunoratidza punctures, hunyoro, kana compression kukuvara kunofanirwa kuvharirwa uye kusashandiswa. PEEK uye zvinogadzirisika zvinogona kuve nehupenyu hupfupi hwesherufu (kazhinji makore matatu) - gara uchitarisa iyo yega chigadzirwa label. Marekodhi ekutevera (nhamba yejeti, kupera, kushandiswa kwemurwere) inofanirwa kuchengetedzwa maererano nemirairo yemunharaunda yeMDR.

XC Medico inobata zvinotevera zvitupa: ISO 13485:2016 (Quality Management System), CE Kumaka pasi peEU MDR 2017/745 (Kirasi IIb), uye CFDA / NMPA kunyoreswa kwemusika weChina. Zvigadzirwa zvakatemerwa misika chaiyo zvinogona kutakura mamwe matendero emunharaunda - bvunza wako wedunhu rekutengesa. Vashandi veOEM vanogona kukumbira marepoti ekuongorora uye Declaration yeConformity zvinyorwa kubva kune yedu Regulatory Affairs timu. Isu hatisi parizvino kubata FDA 510(k) mvumo yemusika weUS; ndapota simbisa kukodzera kwemusika usati waisa maodha eUS-yakasungwa inventory.