XC Medico
Clinical Academy

Zonse za XC Medico metallic implants (Titanium Ti-6Al-4V ndi 316L Stainless Steel) zimagwirizana ndi sterilization ya steam autoclave pa 134 ° C / 273 ° F kwa mphindi zosachepera 18 (kuzungulira kwa vacuum). Kwa PEEK interbody cages, gwiritsani ntchito 134 ° C kwa mphindi 4 musanayambe vacuum. Matayala a zida ayenera kukulungidwa m'matumba ogwiritsidwa ntchito kamodzi. EtO (ethylene oxide) yotseketsa pa ≤55 ° C imavomerezedwanso pazigawo zomwe sizimva kutentha. Osagwiritsa ntchito zakumwa zoziziritsa kukhosi/zozizira chifukwa zitha kusokoneza zokutira pamwamba. IFU Yathunthu (Malangizo Ogwiritsiridwa Ntchito) yofotokoza ma protocol oletsa kutsekereza imaphatikizidwa muzopaka zilizonse.

XC Medico imagwiritsa ntchito Ti-6Al-4V ELI (Extra-Low Interstitial) Grade 23 pa ASTM F136, muyezo wachipatala. Katundu wofunikira: Mphamvu zolimba ≥860 MPa , zokolola mphamvu ≥795 MPa, elongation ≥10%. Kuphatikizika kwa aloyi ndi 90% Titaniyamu, 6% Aluminiyamu, 4% Vanadium. Mafupa a mafupa ndi zomangira amapatsidwa amtundu wa II anodization kuti apititse patsogolo kukana kwa dzimbiri ndi osseointegration. mankhwala Aloyiyi ili ndi MRI-zoyenera ku 1.5T ndi 3T yokhala ndi mawonekedwe apadera omwe amafotokozedwa mwatsatanetsatane pazolemba zamalonda.

Zoyika zonse za Titanium zochokera ku XC Medico zimasankhidwa kukhala MR Conditional pa ASTM F2503. Iwo ali otetezeka pa 1.5T ndi 3.0T kumunda mphamvu ndi pazipita malo gradient 720 G/cm. Ma implants achitsulo chosapanga dzimbiri (316L) alinso ndi MR Conditional koma angayambitse zithunzi zazikulu; kulumikizana ndi radiologist. Osachita MRI mkati mwa masabata a 6 mutayikidwa pokhapokha ngati akufunika kuchipatala. Malire a Specific Absorption Rate (Specific Absorption Rate) amaperekedwa muzolemba za IFU za chinthu chilichonse chomwe chili mu Resource Center pamwambapa.

Zomangira zomangitsa zomaliza zimasiyana ndi wononga m'mimba mwake: 3.5mm zomangira zomangira: 1.2–1.5 Nm , 4.5mm zomangira zomangira: 2.0–2.5 Nm , 5.0mm zomangira zomangira: 2.8–3.2 Nm , 6.5mm zomangira zomangira: 3.5-4.0 . Nthawi zonse gwiritsani ntchito screwdriver yoletsa ma torque ndipo musapitirire kuchuluka kwa torque kuti mupewe kuvula makina otsekera kapena kuwotcherera kozizira. Ngati kukana pamanja kumamveka poikapo musanafikire kuya komaliza, imani ndi kutsimikizira kukula kwa bowolo ndi dzanja lolondola. Zomangira zovula zimafunikira zida zapadera zochotsera zomwe zimapezeka padera.

Ma implants a XC Medico muzopaka zosabala amakhala ndi shelufu ya zaka 5 kuchokera tsiku lopangidwa (onani lemba). Kusungirako: kutentha +5 ° C mpaka + 30 ° C , chinyezi chapafupi 15-85% chosasunthika , kutali ndi kuwala kwa dzuwa ndi mankhwala owononga. Chotengera chilichonse chowonetsa ma punctures, chinyezi, kapena kupsinjika kwapang'onopang'ono kuyenera kukhala kwaokha osagwiritsidwa ntchito. PEEK ndi zida zotha kubweza zitha kukhala ndi moyo wanthawi yayitali (nthawi zambiri zaka 3) - nthawi zonse fufuzani chizindikiro cha chinthu chilichonse. Zolemba zotsatiridwa (nambala ya gawo, kutha ntchito, kugwiritsidwa ntchito kwa odwala) ziyenera kusungidwa malinga ndi malamulo a MDR amderali.

XC Medico ili ndi ziphaso zotsatirazi: ISO 13485:2016 (Quality Management System), CE Marking pansi pa EU MDR 2017/745 (Class IIb), ndi CFDA / NMPA kulembetsa ku msika waku China. Zogulitsa zomwe zikupita kumisika inayake zitha kukhala ndi zivomerezo zina zakomweko - funsani wolumikizana nawo mdera lanu. Othandizana nawo a OEM atha kupempha malipoti owerengera ndi zikalata za Declaration of Conformity ku gulu lathu la Regulatory Affairs. Pakali pano tilibe chilolezo cha FDA 510(k) kumsika waku US; chonde tsimikizirani kuti ndinu oyenerera kumsika musanatumize maoda a zinthu zopita ku US.