XC Medico
Clinical Academy

Tag nrho XC Medico metallic implants (Titanium Ti-6Al-4V thiab 316L Stainless Steel) yog sib xws nrog chav autoclave sterilization ntawm 134 ° C / 273 ° F rau yam tsawg kawg ntawm 18 feeb (ua ntej lub tshuab nqus tsev vacuum). Rau PEEK interbody tawb, siv 134 ° C rau 4 feeb ua ntej lub tshuab nqus tsev. Cov tais diav yuav tsum tau muab qhwv rau hauv ib lub hnab ntim khoom siv. EtO (ethylene oxide) sterilization ntawm ≤55 ° C kuj tau pom zoo rau cov khoom kub-rhiab heev. Tsis txhob siv tshuaj lom neeg / cov kua dej txias kom tsis muaj menyuam vim tias cov no tuaj yeem cuam tshuam cov txheej txheem saum npoo. Tag Nrho IFU (Cov Lus Qhia rau Kev Siv) qhia txog kev ua kom tsis muaj menyuam muaj nyob rau hauv txhua lub ntim khoom.

XC Medico siv Ti-6Al-4V ELI (Ntxiv-Low Interstitial) Qib 23 rau ASTM F136, tus qauv kho mob qib. Cov khoom tseem ceeb: Tensile zog ≥860 MPa , yield zog ≥795 MPa, elongation ≥10%. Cov alloy muaj pes tsawg leeg yog 90% Titanium, 6% Aluminium, 4% Vanadium. Cov pob txha daim hlau thiab cov ntsia hlau tau dhau los ua hom II anodization nto kho kom txhim khu kev tiv thaiv corrosion thiab osseointegration. Cov hlau no yog MRI-conditional ntawm 1.5T thiab 3T nrog rau cov txheej txheem scan tshwj xeeb hauv cov ntawv sau npe.

Tag nrho Titanium-based XC Medico cog yog cais raws li MR Conditional ib ASTM F2503. Lawv muaj kev nyab xeeb ntawm 1.5T thiab 3.0T teb lub zog nrog qhov siab tshaj plaws spatial gradient ntawm 720 G / cm. Stainless hlau implants (316L) kuj yog MR Conditional tab sis yuav ua rau cov duab kos duab loj dua; koom tes nrog tus kws kho mob radiologist. Tsis txhob ua MRI hauv 6 lub lis piam ntawm kev cog qoob loo tshwj tsis yog kev kho mob ceev. Specific SAR (Specific Absorption Rate) txwv thiab kev txwv qhov chaw yog muab rau hauv ib tus neeg cov khoom IFU cov ntaub ntawv muaj nyob rau hauv Resource Center saum toj no.

Pom zoo kawg zawm torques txawv ntawm cov ntsia hlau taub: 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 . Ib txwm siv lub ntsuas qhov ntsuas qhov ntsuas qhov ntsuas qhov ntsuas qhov ntsuas thiab tsis txhob tshaj qhov siab tshaj plaws torque kom tsis txhob rub lub ntsuas phoo los yog txias-vuam. Yog tias phau ntawv tiv thaiv tau hnov ​​​​thaum lub sij hawm ntxig ua ntej mus txog qhov kawg qhov tob, nres thiab xyuas seb qhov laum qhov taub nrog lub tes tsho qhia qhov tseeb. Stripped locking screws yuav tsum muaj cov khoom siv tshem tawm tshwj xeeb muaj cais.

XC Medico implants nyob rau hauv lub ntim tsis muaj menyuam muaj lub neej txee ntawm 5 xyoo txij li hnub tsim khoom (saib daim ntawv lo). Cia tej yam kev mob: kub ntawm +5 ° C mus rau +30 ° C , txheeb ze humidity 15-85% non-condensing , deb ntawm ncaj qha tshav ntuj thiab corrosive tshuaj. Txhua lub ntim uas qhia txog kev sib tsoo, ya raws, lossis kev puas tsuaj yuav tsum raug cais tawm thiab tsis siv. PEEK thiab resorbable Cheebtsam tej zaum yuav muaj luv luv lub neej txee (feem ntau yog 3 xyoos) - nco ntsoov xyuas cov khoom ntawm tus kheej daim ntawv lo. Cov ntaub ntawv taug qab (ntau tus lej, tas sijhawm, siv tus neeg mob) yuav tsum tau khaws cia raws li MDR cov cai hauv zos.

XC Medico tuav cov ntawv pov thawj hauv qab no: ISO 13485: 2016 (Kev Tswj Xyuas Zoo), CE Marking raws li EU MDR 2017/745 (Class IIb), thiab CFDA / NMPA rau npe rau Suav lag luam. Cov khoom lag luam uas tau teev tseg rau kev lag luam tshwj xeeb tuaj yeem muaj kev pom zoo hauv zos ntxiv - sab laj nrog koj tus neeg muag khoom hauv cheeb tsam. Cov neeg koom tes OEM tuaj yeem thov cov ntaub ntawv tshawb xyuas thiab Tshaj Tawm Cov Ntaub Ntawv Ua Raws Cai los ntawm peb pab pawg tswj hwm. Peb tsis tam sim no tuav FDA 510 (k) tshem tawm rau Asmeskas kev lag luam; thov lees paub qhov kev tsim nyog ua lag luam ua ntej muab kev txiav txim rau cov khoom muag hauv Asmeskas.