XC Medico
Clinical Academy

Zonke i-XC Medico implants zetsimbi (Titanium Ti-6Al-4V kunye ne-316L Stainless Steel) ziyahambelana ne -sterilization ye-autoclave yomphunga kwi- 134 ° C / 273 ° F ubuncinane bemizuzu eyi-18 (umjikelo wangaphambi kokutshayela). Kwiikheji ze-PEEK interbody, sebenzisa i-134°C imizuzu emi-4 phambi kokucoca. Iitreyi zesixhobo kufuneka zisongelwe kwiingxowa zokusetyenziswa kanye. I-EtO (i-ethylene oxide) i-sterilization kwi-≤55 ° C nayo ivunyiwe kumacandelo angenayo ubushushu. Musa ukusebenzisa ulwelo lwekhemikhali/olubandayo lokuvala iintsholongwane njengoko ezi zinokubeka esichengeni ukugquma komhlaba. I-IFU epheleleyo (Imiyalelo yokuSetyenziswa) echaza iiprothokholi zokuvala inzala ibandakanyiwe kuyo yonke ipakethe yemveliso.

I-XC Medico isebenzisa i-Ti-6Al-4V ELI (i-Extra-Low Interstitial) iBanga le-23 nge-ASTM F136, umgangatho wonyango. Iimpawu eziphambili: Amandla e-Tensile ≥860 MPa , amandla esivuno ≥795 MPa, elongation ≥10%. Ukubunjwa kwe-alloy yi-90% ye-Titanium, i-6% ye-Aluminium, i-4% yeVanadium. Iipleyiti zethambo kunye nezikrufu zingena kuNyango lwe-II ye-anodization yomgangatho wokuphucula ukuxhathisa ukubola kunye ne-osseointegration. Le alloy i-MRI-conditional kwi-1.5T kunye ne-3T kunye neemeko ezithile zokuskena ezichazwe kwiilebhile zemveliso.

Zonke izifakelo ezisekelwe kwi-Titanium ze-XC Medico zihlelwa njenge- MR Conditional ngokwe-ASTM F2503. Zikhuselekile kwi -1.5T kunye ne-3.0T amandla entsimi kunye ne-gradient yendawo ephezulu ye-720 G / cm. Ukufakelwa kwentsimbi engatyiwa (316L) kukwanguMR ngokwemeko kodwa kunokubangela imifanekiso emikhulu; nxibelelana neradiologist. Musa ukwenza i-MRI kwiiveki ze-6 zokufakelwa ngaphandle kokuba ikliniki ingxamisekile. Specific SAR (Specific Absorption Rate) imida kunye nezithintelo zendawo zibonelelwe kwimveliso nganye amaxwebhu e-IFU afumaneka kwiZiko leZibonelelo ngasentla.

Izikrufu zokuqinisa zokugqibela ezicetyiswayo ziyohluka ngokwedayamitha yesikrufu: 3.5mm izikrufu zecortical: 1.2–1.5 Nm , 4.5mm izikrufu zecortical: 2.0–2.5 Nm , 5.0mm izikrufu zokutshixa: 2.8–3.2 Nm , 6.5mm izikrufu zecortical: 3.5-4 . Ngalo lonke ixesha sebenzisa isikrudrayiva esilinganiselweyo setorque kwaye ungaze ugqithe kwitorque enkulu ukunqanda ukukhulula isixhobo sokutshixa okanye ukuwelda okubandayo. Ukuba ukuxhathisa okwenziwa ngesandla kuvakala ngexesha lokufakwa phambi kokufikelela kubunzulu bokugqibela, yima uze uqinisekise idiamitha yomngxuma wokubhola ngomkhono ochanekileyo wesikhokelo sokubhola. Izikrufu ezihluthiweyo zokutshixa zifuna ikhithi yokususa ekhethekileyo ekhoyo ngokwahlukeneyo.

Ufakelo lwe-XC Medico kwipakethe ecocekileyo engakhuselekanga luphila kwishelufu yeminyaka emi-5 ukusuka kumhla wokwenziwa (jonga ileyibhile). Iimeko zokugcina: iqondo lokushisa +5 ° C ukuya +30 ° C , umswakama ohambelana ne -15-85% u-non-condensing , kude nokukhanya kwelanga kunye neekhemikhali ezitshabalalisayo. Nayiphi na ipakethe ebonisa iipunctures, ukufuma, okanye umonakalo woxinzelelo kufuneka ibekwe yodwa kwaye ingasetyenziswa. I-PEEK kunye nezixhobo ezinokuphinda zixutywe zingaphila kwishelufu emfutshane (ngokuqhelekileyo iminyaka emi-3) - soloko ujonga ileyibhile yemveliso nganye. Iirekhodi zokulandeleka (inombolo yeqashiso, ixesha eliphelelwayo, ukusetyenziswa kwesigulana) kufuneka zigcinwe ngokwemigaqo ye-MDR yendawo.

I-XC Medico ibamba iziqinisekiso ezilandelayo: ISO 13485: 2016 (INkqubo yoLawulo loBulunga), Ukumakishwa kwe-CE phantsi kwe-EU MDR 2017/745 (i-Class IIb), kunye nokubhaliswa kwe-CFDA / NMPA kwimarike yaseTshayina. Iimveliso ezilungiselelwe iimarike ezithile zinokuthwala imvume eyongezelelweyo yasekuhlaleni - qhagamshelana nomthengisi wakho wengingqi. Amaqabane e-OEM angacela iingxelo zophicotho-zincwadi kunye namaxwebhu eSibhengezo sokuThobela kwiqela lethu leMicimbi yoLawulo. Okwangoku asibambeli i-FDA 510(k) imvume kwimarike yase-US; Nceda uqinisekise ukufaneleka kwemarike ngaphambi kokufaka ii-odolo ze-inventri ebotshelelwe e-US.