XC Medico
Clinical Academy

ʻO nā implants metala XC Medico āpau (Titanium Ti-6Al-4V a me 316L Stainless Steel) ua kūpono me ka sterilization autoclave mahu ma 134 ° C / 273 ° F no ka liʻiliʻi o 18 mau minuke (pre-vacuum cycle). No ka PEEK nā hīnaʻi interbody, e hoʻohana i ka 134°C no 4 mau minuke ma mua o ka hoʻomāmā. Pono e wahī ʻia nā pahu mea hana i nā ʻeke hoʻohana hoʻokahi. EtO (ethylene oxide) sterilization ma ≤55 ° C ua ʻae pū ʻia no nā mea wela. Mai hoʻohana i nā wai hoʻoheheʻe kemika/anu no ka mea hiki ke hoʻololi i ka uhi ʻana o ka ʻili. Hoʻokomo ʻia ka IFU piha (Instructions for Use) e wehewehe ana i nā protocol sterilization i loko o kēlā me kēia pahu huahana.

Hoʻohana ʻo XC Medico i ka Ti-6Al-4V ELI (Extra-Low Interstitial) Papa 23 no ka ASTM F136, ke kūlana lāʻau lapaʻau. Nā waiwai koʻikoʻi: Ka ikaika tensile ≥860 MPa , ka ikaika hua ≥795 MPa, elongation ≥10%. ʻO ka hui ʻana he 90% Titanium, 6% Aluminum, 4% Vanadium. Hoʻopili ʻia nā papa iwi a me nā ʻūlū i kahi anodization type II no ka hoʻomaikaʻi ʻana i ke kūpaʻa corrosion a me ka osseointegration. lapaʻau ʻO kēia alloy he MRI-conditional ma 1.5T a me 3T me nā kūlana scan kikoʻī kikoʻī i ka hōʻailona huahana.

Hoʻonohonoho ʻia nā implants XC Medico i hoʻokumu ʻia ma Titanium ma ke ʻano he MR Conditional no ASTM F2503. Palekana lākou ma 1.5T a me 3.0T ikaika kahua me ka gradient spatial kiʻekiʻe o 720 G/cm. ʻO nā implants kila kila (316L) he MR Conditional akā hiki ke hana i nā kiʻi kiʻi nui aʻe; e hui pū me ka radiologist. Mai hana i ka MRI i loko o 6 mau pule o ka hoʻokomo ʻana ke ʻole ka wikiwiki o ke kino. Hāʻawi ʻia nā palena kikoʻī SAR (Specific Absorption Rate) a me nā kau palena i nā palapala IFU huahana pākahi i loaʻa i ka Resource Center ma luna.

ʻOkoʻa ʻia nā torque hoʻopaʻa hope i manaʻo ʻia e ke anawaena wili: 3.5mm nā wili cortical: 1.2–1.5 Nm , 4.5mm nā wili cortical: 2.0–2.5 Nm , 5.0mm nā wili laka: 2.8–3.2 Nm , 6.5mm nā wili hoʻopau: 3.5–4.0 Nm . E hoʻohana mau i ka screwdriver palena torque calibrated a mai ʻoi aku ma mua o ka torque kiʻekiʻe loa e pale aku i ka wehe ʻana i ka mīkini laka a i ʻole ka wili anu. Inā ʻike ʻia ke kūpaʻa lima ma ka hoʻokomo ʻana ma mua o ka hōʻea ʻana i ka hohonu hope, e kū a hōʻoia i ke anawaena o ka lua wili me ka lima alakaʻi wili pololei. Pono nā wili laka i wehe ʻia i kahi pahu wehe kūikawā i loaʻa kaʻawale.

XC Medico implants in intact sterile packaging is a shelf life of 5 makahiki mai ka lā hana (e nānā i ka lepili). Nā kūlana mālama: wela +5°C a +30°C , haʻahaʻa pili 15–85% non-condensing , mamao mai ka lā pololei a me nā kemika corrosive. Pono e hoʻokaʻawale ʻia a ʻaʻole hoʻohana ʻia nā ʻōpala e hōʻike ana i nā punctures, moisture, a i ʻole ka pōʻino hoʻopiʻi. ʻOi aku ka pōkole o ka PEEK a me nā ʻāpana resorbable (maʻamau 3 mau makahiki) - e nānā mau i ka lepili huahana. Pono e mālama ʻia nā moʻolelo traceability (helu nui, ka pau ʻana, ka hoʻohana ʻana i nā mea maʻi) no nā lula MDR kūloko.

Loaʻa iā XC Medico nā palapala hōʻoia: ISO 13485: 2016 (Quality Management System), CE Marking ma lalo o EU MDR 2017/745 (Class IIb), a me CFDA / NMPA hoʻopaʻa inoa no ka mākeke Kina. Hiki i nā huahana i koho ʻia no nā mākeke kikoʻī ke lawe i nā ʻae kūloko hou aʻe - e nīnau i kāu kelepona kūʻai kūloko. Hiki i nā hoa OEM ke noi i nā hōʻike loiloi a me nā palapala Hoʻolaha o ka Conformity mai kā mākou hui Regulatory Affairs. ʻAʻole mākou paʻa i kēia manawa FDA 510 (k) ʻae no ka mākeke US; e ʻoluʻolu e hōʻoia i ka pono o ka mākeke ma mua o ke kau ʻana i nā kauoha no ka waihona waiwai pili i ka US.