XC Medico
Klinik Akademi

כl di XC Medico mεtal implant dεm (Titanium Ti-6Al-4V εn 316L Stainless Steel) kכmpatibl wit stim כtoklev stεrilayzεsh כn na 134°C / 273°F fכ minimכm 18 minit (pri-vεkyum saykl). Fɔ PEEK intabɔdi kech, yuz 134°C fɔ 4 minit bifo vaykum. Instrumɛnt trey dɛn fɔ rap insay paus dɛn we pɔsin kin yuz wan tɛm nɔmɔ. EtO (ethylene oxide) sterilization na ≤55°C dεn apruv bak fכ hεt-sεnsitiv kכmכpכnt dεm. Nɔ yuz kemikal/kol stɛrilayzeshɔn likwid bikɔs dɛn tin ya kin kɔmprɔmis di sɔfayz kɔtin dɛn. Ful IFU (Instructions for Use) we de tɔk mɔ bɔt sterilayzeshɔn protɔkɔl dɛn de insay ɛvri prɔdak pak.

XC Medico de yuz Ti-6Al-4V ELI (Extra-Low Interstitial) Gret 23 fɔ ɛni ASTM F136, we na di mɛdikal-grɛd standad. Ki prכpati dεm: Tεnsil strכng ≥860 MPa , yield strכng ≥795 MPa, εlongeshכn ≥10%. Di alɔy kɔmpɔzishɔn na 90% Taytaniɔm, 6% Aluminium, 4% Vanadiɔm. di bon plet dεm εn skru dεm de כnda wan Tayp II anodayzεshכ n sεf tritmεnt fכ εnhans kכrכshכn rεsistεns εn osseointegration. Dis alɔy na MRI-kɔndishɔnal na 1.5T ɛn 3T wit spɛsifi k skan kɔndishɔn dɛn we dɛn ditayla insay di prɔdak lɛbul.

Ɔl di Titanium-based XC Medico implant dɛn de klas as MR Kɔndishɔnal per ASTM F2503. Dɛn sef na 1.5T ɛn 3.0T fil trɛnk wit maksimal spatial gradient we na 720 G/cm. Stenlɛs stiɛl implant dɛn (316L) na MR Kɔndishɔnal bak bɔt dɛn kin mek big imej artifakt dɛn; kɔdinɛt wit di raydiɔlɔjis. Nɔ du MRI insay 6 wiks afta yu put am pas nɔmɔ if yu nid fɔ du am kwik kwik wan na di klinik. Spɛsifi k SAR (Spɛsifi k Absɔpshɔn Rɛt) limit ɛn pozishɔn ristrikshɔn dɛn de insay di wan wan prɔdak IFU dɔkyumɛnt dɛn we de na di Rishɔs Sɛnta we de ɔp.

Di fainal taytning tork dεm we dεn rεkomεnd de difrεnt bay skru dayamita: 3.5mm kכrtikכl skru dεm: 1.2–1.5 Nm , 4.5mm kכrtikכl skru dεm: 2.0–2.5 Nm , 5.0mm lכk skru dεm: 2.8–3.2 Nm , 6.5mm kansεl skru dεm: 3.5–4.0 Nm . Ɔltɛm yuz skru drayva we gɛt kalibrayt tɔk-limitin ɛn nɔ ɛva pas di maksimal tɔk fɔ avɔyd fɔ pul di lɔk mɛkanism ɔ kol-wɛldin. If yu fil manual resistans we yu de insay bifo yu rich di las dip, stɔp ɛn chɛk di drɔl ol dayamita wit di kɔrɛkt drɔl gayd sliv. Strip locking screws nid spɛshal rimoval kit we de sɛpret.

XC Medico implant dεm we de insay intakt stεrili pak gεt shelf layf fכ 5 ia frכm di de we dεn mek am (luk di lεbul). Di kɔndishɔn fɔ kip: tɛmpracha +5°C to +30°C , rilitiv humiditi 15–85% nɔ-kɔndɛns , fa frɔm dairekt san layt ɛn kɔrosiv kemikal. Ɛni pak we de sho pankchɔ, mɔstɔ, ɔ kɔmpreshɔn damej fɔ de na kwarantin ɛn nɔ fɔ yuz am. PEEK ɛn risɔrbabl kɔmpɔnɛnt dɛn kin gɛt shɔt shelf layf (tipikli 3 ia) — ɔltɛm chɛk di wan wan prɔdak lɛbl. Traceability rεkɔd (lɔt nɔmba, εkspεri, pasεnt yus) fɔ mεnten bay di lokal MDR rigyulεshɔn.

XC Medico gɛt dɛn sɛtifiket ya: ISO 13485:2016 (Kwaliti Manejmɛnt Sistɛm), CE Mak ɔnda EU MDR 2017/745 (Klas IIb), ɛn CFDA / NMPA rɛjista fɔ di Chaynish makit. Prodak dɛn we dɛn destin fɔ sɔm patikyula makit dɛn kin kɛr ɔda lokal aprɔval dɛn — kɔnsul yu rijinal sɛl kɔntakt. OEM patna dɛn kin aks fɔ ɔdit ripɔt ɛn Diklɛreshɔn ɔf Kɔnfɔmiti dɔkyumɛnt frɔm wi Rigyulatɔri Afɛj tim. Naw wi nɔ de ol FDA 510(k) kliarens fɔ di US makit; duya kɔnfɔm di makɛt ɛligibiliti bifo yu mek ɔda fɔ US-baund invɛntari.