XC Medico
Clinical Academy-ah hian a chhuak leh ta a ni

XC Medico metallic implant zawng zawng (Titanium Ti-6Al-4V leh 316L Stainless Steel) te hi steam autoclave sterilization nen 134°C / 273°F ah minute 18 aia tlem lo (pre-vacuum cycle) hman theih a ni. PEEK interbody cage atan chuan 134°C ah minute 4 chhung pre-vacuum hmang ang che. Instrument tray te chu vawi khat hmanna tur pouch-ah khuh tur a ni. Heat-sensitive components tan pawh ≤55°C-a EtO (ethylene oxide) sterilization phalsak a ni bawk. Chemical/cold sterilization liquid hmang suh, hengte hian surface coatings a tichhe thei a ni. Sterilization protocol chipchiar taka tarlanna Full IFU (Instructions for Use) chu product packaging tinah a awm vek a ni.

XC Medico hian ASTM F136 angin Ti-6Al-4V ELI (Extra-Low Interstitial) Grade 23 a hmang a , hei hi medical-grade standard a ni. Thil pawimawh tak tak: Tensile strength ≥860 MPa , yield strength ≥795 MPa, elongation ≥10%. Alloy composition hi 90% Titanium, 6% Aluminium, 4% Vanadium a ni. Bone plate leh screw te hian Type II anodization surface treatment an nei a, hei hian corrosion resistance leh osseointegration a tichak a ni. He alloy hi 1.5T leh 3T-ah MRI-conditional a ni a, scan condition bikte chu product labeling-ah chipchiar takin tarlan a ni.

Titanium hmanga siam XC Medico implant zawng zawng hi MR Conditional anga classified a ni. Field strength ASTM F2503 angin ah an him a 1.5T leh 3.0T- , spatial gradient sang ber chu 720 G/cm a ni. Stainless steel implant (316L) pawh MR Conditional ni mahse image artifact lian zawk a thlen thei a; radiologist nen inremna siam rawh. Clinically urgent a nih loh chuan implantation atanga kar 6 chhungin MRI tih loh tur. SAR (Specific Absorption Rate) limit bik leh positioning restrictions te chu a chunga Resource Center-a individual product IFU documents awmah hian tarlan a ni.

Final tightening torque rawt chu screw diameter a zirin a inang lo: 3.5mm cortical screw: 1.2–1.5 Nm , 4.5mm cortical screw: 2.0–2.5 Nm , 5.0mm locking screw: 2.8–3.2 Nm , 6.5mm cancellous screw: 3.5–4.0 Nm Calibrated torque-limiting screwdriver hmang fo la, locking mechanism stripping emaw cold-welding emaw pumpelh nan torque sang ber aia tam hmang ngai suh. Final depth a thlen hmaa insertion laiin manual resistance a hriat chuan drill guide sleeve dik tak hmangin drill hole diameter chu titawp la, verify rawh. Stripped locking screw te hian specialized removal kit a hranpaa awm a ngai a ni.

XC Medico implants intact sterile packaging-ah hian kum 5 chhung a awm thei (label en rawh). siam a nih atanga A dahna tur hmun: temperature +5°C atanga +30°C , relative humidity 15–85% non-condensing , ni êng direct leh corrosive chemicals atanga hla takah. Packaging eng pawh puncture, moisture, emaw compression damage awmna chu quarantine tur a ni a, hman loh tur a ni. PEEK leh resorbable components te hian shelf life tawi zawk (a tlangpuiin kum 3) an nei thei — product pakhat zel label chu enfiah fo ang che. Traceability record (lot number, expiry, damlo hman dan) chu tualchhung MDR dan angin vawn reng tur a ni.

XC Medico hian a hnuaia certification te hi a nei a, chungte chu: ISO 13485:2016 (Quality Management System), EU MDR 2017/745 (Class IIb) hnuaia CE Marking , leh CFDA / NMPA registration te a ni . Chinese market tana Market bik atana ruahman product-te hian local approval dang an keng tel thei — i regional sales contact zawt rawh. OEM partner-te chuan kan Regulatory Affairs team hnen atangin audit report leh Declaration of Conformity documents te an dil thei ang. Tunah hian US market tan FDA 510(k) clearance kan nei lo a; US-bound inventory order i siam hmain market eligibility kha confirm hmasa phawt ang che.