XC Medico
Dɔgɔtɔrɔso Akademi

XC Medico nɛgɛdaga bɛɛ (Titanium Ti-6Al-4V ani 316L Stainless Steel) bɛ se ka kɛ ni sterilize ye ni otoclave vapeur ye 134°C / 273°F la miniti 18 la dɔgɔmannin (cycle pre-vacuum). Ni PEEK farikolo ni ɲɔgɔn cɛ kafew don, aw bɛ 134°C kɛ miniti 4 kɔnɔ sani aw ka a labɔ. Minɛnw bilayɔrɔw ka kan ka siri foroko kɔnɔ minnu bɛ kɛ siɲɛ kelen. EtO (ɛtilɛni ɔkisidi) sterilize ≤55°C fana dabɔra funteni-sɛnɛfɛnw na. Aw kana baara kɛ ni kemikɛli/nɛnɛjiw ye minnu bɛ sterilize kɛ barisa o bɛ se ka sanfɛla datugulanw tiɲɛ. IFU dafalen (Instructions for Use) min bɛ sterilize protocoles ɲɛfɔ, o bɛ sɔrɔ furaw foroko bɛɛ kɔnɔ.

XC Medico bɛ Ti-6Al-4V ELI (Extra-Low Interstitial) Grade 23 kɛ ka kɛɲɛ ni ASTM F136 ye, o ye furakɛli hakɛ sariya ye. Nafa jɔnjɔnw : A sɔgɔli fanga ≥860 MPa , sɔrɔ fanga ≥795 MPa, janya ≥10%. A bɛ kɛ ni 90% Titanium ye, 6% Aluminiyɔmu, 4% Vanadium ye. Kolow bɛ kɛ ni anodization surface treatment suguya II ye walasa ka sɔgɔsɔgɔninjɛ kunbɛnni ni kolotugudaw fara ɲɔgɔn kan. Nin bɔgɔlan in ye MRI-conditional ye 1,5T ani 3T la ni scan cogoya kɛrɛnkɛrɛnnenw ye minnu ɲɛfɔlen don ka ɲɛ furaw taamasiɲɛw kɔnɔ.

Titanium basigilen XC Medico fɛnw bɛɛ bɛ jate MR Conditional ka kɛɲɛ ni ASTM F2503 ye. U lakananen don ni foro fanga ye 1,5T ani 3,0T ye ni yɔrɔ jiginni hakɛ cayalenba ye 720 G/cm ye. Inox implants (316L) fana ye MR Conditional ye nka u bɛ se ka kɛ sababu ye ka ja artifacts belebelebaw sɔrɔ; aw bɛ jɛ ka baara kɛ ni kɛnɛyabaarakɛla ye. Aw kana MRI kɛ dɔgɔkun 6 kɔnɔ a donli kɔfɛ fo ni a kɛra kɔrɔtɔko ye kɛnɛyaso la. SAR (Specific Absorption Rate) dan kɛrɛnkɛrɛnnenw ani jɔyɔrɔko dantigɛliw bɛ sɔrɔ fɛn kelen-kelen bɛɛ IFU sɛbɛnw kɔnɔ minnu bɛ sɔrɔ Resource Center kɔnɔ sanfɛ.

Kɔrɔlen sirili girinya minnu bɛ fɔ, olu bɛ danfara ka kɛɲɛ ni kuru cɛmancɛ ye: 3,5mm kɔri kuru: 1,2–1,5 Nm , 4,5mm kɔri kuru: 2,0–2,5 Nm , 5,0mm datugulan: 2,8–3,2 Nm , 6,5mm kansɛri kuru: 3,5–4,0 Nm Aw bɛ baara kɛ tuma bɛɛ ni girinya dantigɛlan ye min kalifara ani aw kana tɛmɛ girinya hakɛ dantɛmɛnen kan abada walasa aw kana da tugulan bɔ a la walima ka nɛnɛ-welding kɛ. Ni bololabaara bɛ ye a dontuma na sani a ka se a juguman laban ma, aw bɛ a jɔ ani ka foro dingɛ cɛmancɛ sɛgɛsɛgɛ ni foroko ɲɛminɛlan bololanɛgɛ ɲuman ye. Datugulanw minnu bɔra u la, olu bɛ bɔli kɛminɛn kɛrɛnkɛrɛnnen dɔ de wajibiya min bɛ sɔrɔ u danma.

XC Medico fɛnw donna foroko sterili tiɲɛnenw kɔnɔ, u marali waati ye san 5 ye ka bɔ u dilanni don na (aw ye sɛbɛn ɲɛ sɛbɛn lajɛ). A maracogo : funteni +5°C fo +30°C , nɛnɛ hakɛ 15–85% min tɛ wuli , a yɔrɔ ka jan tile yeelen tilennen ni kemikɛlifɛnw na minnu bɛ fɛnw tiɲɛ. Foroko fɛn o fɛn bɛ sɔgɔsɔgɔninjɛ, ji, walima degun tiɲɛni jira, o ka kan ka bila dankan na, wa u man kan ka kɛ. PEEK ni a yɔrɔ minnu bɛ se ka segin ka wuli, olu ka waati bɛ se ka surunya (a ka ca a la san 3) — aw bɛ fura kelen-kelen bɛɛ tɔgɔ lajɛ tuma bɛɛ. Traceability sɛbɛnw (loti nimɔrɔ, waati tɛmɛnen, banabagatɔw tali) ka kan ka mara ka kɛɲɛ ni sigida MDR sariyaw ye.

XC Medico bɛ nin seereyaw sɔrɔ : ISO 13485:2016 (Quality Management System), CE Marking ka kɛɲɛ ni EU MDR 2017/745 (Class IIb) ye, ani CFDA / NMPA sɛbɛnni Sinuwa sugu la. Fɛn minnu bɛ taa sugu kɛrɛnkɛrɛnnenw na, olu bɛ se ka kɛ ni sigida ka sɔnni wɛrɛw ye — aw ye aw ka mara feerekɛlaw lajɛ. OEM jɛɲɔgɔnw bɛ se ka jatebɔ rapɔɔriw ni bɛnkansɛbɛnw ɲini an ka sariyasunba jɛkulu fɛ. An tɛ FDA 510(k) ka yamaruya sɔrɔ sisan Ameriki sugu la; aw ka sugu setigiya dafa sani aw ka komandi kɛ Ameriki-taamafɛnw na.