XC Medico
Clinical Academy

Dhammaan XC Medico metallic implants (Titanium Ti-6Al-4V iyo 316L Stainless Steel) waxay la jaan qaadayaan jeermiska autoclave uumiga at 134°C/273°F ugu yaraan 18 daqiiqo (wareeg-vacuum pre-vacuum). Qafisyada PEEK ee dadka dhexdooda, isticmaal 134°C 4 daqiiqo kahor faaruqinta. Saxarada qalabka waa in lagu duuduubaa shandadyo la isticmaalo. EtO (etylene oxide) jeermis-dillaaca ≤55°C ayaa sidoo kale loo oggolaaday qaybaha kulaylka-xasaasiga ah. Ha isticmaalin dareere jeermis-dilis kiimiko/qabow maxaa yeelay kuwani waxay wax u dhimi karaan dahaarka dusha sare. IFU buuxda (tilmaamaha isticmaalka) ee faahfaahinaya borotokoolka jeermiska ayaa lagu daray baakad kasta oo badeecad ah.

XC Medico waxay isticmaashaa Ti-6Al-4V ELI (Extra-Low Interstitial) Fasalka 23 halkii ASTM F136, heerka heerka caafimaadka. Hantida muhiimka ah: Xoog xajin ≥860 MPa , xoog dhalid ≥795 MPa, elongation ≥10%. Halabuurka daawaha waa 90% Titanium, 6% Aluminium, 4% Vanadium. Taarikada lafaha iyo boolal waxay maraan daawaynta nooca II anodization dusha si kor loogu qaado iska caabinta daxalka iyo isdhexgalka lafaha. Alloyskan waa MRI-shuruudaha 1.5T iyo 3T oo leh xaalado gaar ah oo sawir ah oo lagu faahfaahiyay calaamadaynta alaabta.

All Titanium-based XC Medico implants waxa loo kala saaray MR Shardi ah halkii ASTM F2503. Waxay ku badbaadsan yihiin 1.5T iyo 3.0T xoogga goobta oo leh ugu badnaan jaangooyooyin 720 G/cm. Maqaaradaha birta-la'aanta ah (316L) sidoo kale waa shuruudo MR laakiin waxay keeni karaan sawirro farshaxan oo waaweyn; la xiriir raadiyaha. Ha samayn MRI 6 toddobaad gudahood marka la geliyo haddii aan caafimaad ahaan degdeg ahayn. Xaddidaadaha SAR ee gaarka ah (Qiimaha nuugista Gaarka ah) iyo xaddidaadaha meelaynta ayaa lagu bixiyay sheyga gaarka ah ee IFU dukumeentiyada laga heli karo Xarunta Kheyraadka ee sare.

Hirarka adkaynta kama dambaysta duwan yihiin dhexroorka birta: 3.5mm birta kortikal: 1.2-1.5 , Nm , 4.5mm , ah ee lagu taliyay waxay ku kala Had iyo jeer isticmaal kaashawiito xaddidan oo xaddidaysa oo waligaa ha dhaafin qulqulka ugu badan si aad uga fogaato in aad iska saarto habka qufulka ama alxanka qabowga. Haddii caabbinta gacanta la dareemo inta la gelinayo ka hor inta aan la gaarin gunta ugu dambeysa, joogso oo ku xaqiiji dhexroorka daloolka gacanta gacanta saxda ah ee hagaha. Furayaasha qufulka ee la jeexay waxay u baahan yihiin qalab saarista khaaska ah oo si gaar ah loo heli karo.

Xirmooyinka XC Medico ee ku jira baakadaha nadiifka ah ee nadiifka ah waxay leeyihiin cimrigooda shelf ee 5 sano laga bilaabo taariikhda wax soo saarka (fiiri calaamadda). Xaaladaha kaydinta: heerkulka +5°C ilaa +30°C , qoyaan qaraabo ah 15–85% aan qaboojinayn , kana fog iftiinka qoraxda iyo kiimikooyinka daxalka leh. Baakad kasta oo muujinaysa daloolno, qoyaan, ama burbur waa in la karantiilo oo aan la isticmaalin. PEEK iyo qaybaha dib loo soo celin karo waxay yeelan karaan nolol shelf gaaban (sida caadiga ah 3 sano) - had iyo jeer hubi calaamadda alaabta gaarka ah. Diiwaanada raadinta (lambarka fara badan, dhacayo, isticmaalka bukaanka) waa in la ilaaliyaa sida uu dhigayo xeerarka MDR maxalliga ah.

XC Medico waxay haysaa shahaadooyinkan soo socda: ISO 13485: 2016 (Nidaamka Maareynta Tayada), Calaamadaynta CE ee hoos timaada EU MDR 2017/745 (Class IIb), iyo diiwaangelinta CFDA / NMPA ee suuqa Shiinaha. Alaabooyinka loogu talagalay suuqyo gaar ah ayaa laga yaabaa inay wataan oggolaansho maxalli ah oo dheeri ah - la tasho xiriirkaaga iibka ee gobolka. Wada-hawlgalayaasha OEM waxa laga yaabaa inay ka codsadaan warbixinnada hantidhawrka iyo ku dhawaaqista dukumentiyada waafaqsan kooxdayada Arrimaha Sharcigu. Hadda ma hayno ogolaanshaha FDA 510 (k) ee suuqa Maraykanka; fadlan xaqiiji u-qalmitaanka suuqa ka hor intaadan dalban dalabaadka alaabada ku xidhan Maraykanka.