XC Medico
Dɔnɔdzikpɔƒe ƒe Suku

XC Medico ƒe ga siwo katã wotsɔ dea lãme na ame (Titanium Ti-6Al-4V kple 316L Stainless Steel) sɔ kple steam autoclave sterilization le 134°C / 273°F hena miniti 18 ya teti (do ŋgɔ na vacuum cycle). Le PEEK interbody cages gome la, zã 134°C hena miniti 4 do ŋgɔ na vacuum. Ele be woaxatsa haƒonuwo ƒe agbawo ɖe kotoku siwo woate ŋu azã zi ɖeka me. Woda asi ɖe EtO (ethylene oxide) ƒe dɔlékuiwutikewo zazã le ≤55°C hã dzi na akpa siwo sea dzoxɔxɔ gɔme. Mègazã atike/tsi fafɛ siwo wotsɔna tsia dɔlékuiwutikewo nu o elabena esiawo ate ŋu agblẽ nu le nusiwo wotsɔ blaa anyigba dzi ŋu. IFU (Instructions for Use) blibo si gblɔ vidzidzi ƒe ɖoɖowo tsitotsito la dea atike ɖesiaɖe ƒe bablawo me.

XC Medico zãa Ti-6Al-4V ELI (Extra-Low Interstitial) ƒe Dzeside 23 le ASTM F136, si nye atikewɔwɔ ƒe dzeside ƒe dzidzenu nu. Nɔnɔme veviwo: Tensile ŋusẽ ≥860 MPa , kutsetse ƒe ŋusẽ ≥795 MPa, didime ≥10%. Nusiwo wotsɔ wɔe nye 90% Titanium, 6% Aluminium, 4% Vanadium. Ƒu ƒe gbadzɛwo kple gaviwo toa Type II anodization surface treatment me be woatsɔ ado ŋusẽ xɔdzo ƒe tsitretsitsi kple osseointegration. Alloy sia nye MRI-nɔnɔme le 1.5T kple 3T kple scan nɔnɔme tɔxɛ siwo ŋu woƒo nu tsoe tsitotsito le atike ƒe dzeside me.

Woda XC Medico ƒe atike siwo katã wotu ɖe Titanium dzi la ɖe hatsotso si nye MR Conditional me le ASTM F2503 nu. Wole dedie le 1.5T kple 3.0T agble ƒe ŋusẽ me kple teƒe ƒe ʋuʋu si sɔ gbɔ wu 720 G/cm. Stainless steel implants (316L) hã nye MR Conditional gake ateŋu ahe nɔnɔmetata ƒe asinudɔwɔwɔ siwo lolo wu vɛ; wɔ ɖoɖo kple keklẽŋusẽŋutinunyala. Mègawɔ MRI le kwasiɖa 6 me tso esime wodoe ɖe lãme na wò o negbe ɖe wòhiã kpata le atikewɔnyawo me hafi. Wona SAR (Specific Absorption Rate) ƒe seɖoƒe tɔxɛwo kple teƒe si woaɖo wo ɖo le adzɔnu ɖekaɖekawo ƒe IFU nuŋlɔɖi siwo le Dɔwɔnuwɔƒe si le etame la me.

Wokafui mamlɛtɔ ƒe sesẽme ƒe ŋusẽwo toa vovo le gavi ƒe didime nu: 3.5mm cortical screws: 1.2–1.5 Nm , 4.5mm cortical screws: 2.0–2.5 Nm , 5.0mm locking screws: 2.8–3.2 Nm , 6.5mm cancellous screws: 3.5–4.0 Nm . Zã ʋuƒo si seɖoƒe li na ʋua ƒe ŋusẽ si wodo kpɔ ɣesiaɣi eye mègawu ŋusẽ si sɔ gbɔ wu gbeɖe o be nàƒo asa na ʋua ƒe ʋuƒoa ɖeɖeɖa alo fafɛ-welding. Ne wose asi ƒe tsitretsitsi le edede me hafi ɖo gogloƒe mamlɛtɔ la, tɔ eye nàtsɔ do si me woɖe doa le ƒe didime akpɔe ɖa kple doa ƒe mɔfianu ƒe abɔta si sɔ. Kplu siwo wotsɔ xea mɔe siwo woɖe le wo ŋu la hiã na nu tɔxɛ aɖe si woatsɔ aɖee ɖa si woate ŋu akpɔ ɖe vovo.

XC Medico ƒe atike siwo wotsɔ dea nubablɛ siwo me dɔlékui mele o me ƒe agbenɔƒe nye ƒe 5 tso ŋkeke si dzi wowɔ wo dzi (kpɔ ŋkɔ si woŋlɔ ɖe wo dzi). Nudzraɖoƒe ƒe nɔnɔmewo: dzoxɔxɔ +5°C va ɖo +30°C , fafa si sɔ gbɔ 15–85% non-condensing , adzɔge tso ɣe ƒe keklẽ tẽ kple atike siwo gblẽa nu gbɔ. Ele be woaɖe agba ɖesiaɖe si me woɖe do, tsi, alo nutete ƒe nugbegblẽ le la ɖe vovo eye womagazãe o. PEEK kple akpa siwo woate ŋu agbugbɔ axɔ ate ŋu anɔ kpuie wu (zi geɖe la, ƒe 3) — lé ŋku ɖe nu ɖekaɖekawo ƒe ŋkɔ ŋu ɣesiaɣi. Ele be woalé ŋkuléleɖenuŋu ŋuti nuŋlɔɖiwo (lot ƒe xexlẽdzesi, ɣeyiɣi si wu enu, dɔnɔwo ƒe zazã) ɖe te le nutoa me MDR ƒe sewo nu.

XC Medico xɔ ɖaseɖigbalẽ siwo gbɔna: ISO 13485:2016 (Dzesidede Nyuiwo Dzikpɔkpɔ ƒe Ðoɖo), CE Dzeside le EU MDR 2017/745 (Klass IIb), kple CFDA / NMPA ƒe ŋkɔ dede agbalẽ me na Chinatɔwo ƒe asi. Adzɔnu siwo woɖo ɖe asi aɖewo koŋ me ate ŋu atsɔ nutoa me ƒe mɔɖeɖe bubuwo ɖe asi — bia wò nutome nudzralawo ƒe kadodo. OEM ƒe hadɔwɔlawo ate ŋu abia agbalẽdzikpɔkpɔ ŋuti nyatakakawo kple Nyatakaka si ku ɖe Ðekawɔwɔ Ŋu ƒe nuŋlɔɖiwo tso míaƒe Dɔwɔha si Kpɔa Dɔwɔnyawo Gbɔ gbɔ. Míexɔ FDA 510(k) ƒe mɔɖeɖe ɖe United States ƒe asi ŋu fifia o; taflatse ɖo kpe asi ƒe dzedze dzi hafi nàwɔ nudɔdɔwo na nudzraɖoƒe siwo woɖo ɖe United States.