XC Medico
Ayaresabea Adesuabea

XC Medico dadeɛ a wɔde hyɛ nipadua mu nyinaa (Titanium Ti-6Al-4V ne 316L Stainless Steel) ne steam autoclave sterilization wɔ 134°C / 273°F anyɛ yie koraa no simma 18 (pre-vacuum cycle) hyia. Wɔ PEEK interbody cages ho no, fa 134°C di dwuma simma 4 ansa na wɔayɛ vacuum. Ɛsɛ sɛ wɔde nnwinnade tray ahorow kyekyere nkotoku a wɔde di dwuma pɛnkoro mu. Wɔapene EtO (ethylene oxide) sterilization a ɛwɔ ≤55°C nso so ama nneɛma a ɛyɛ hyew. Mfa nnuru/nwini a wɔde yɛ sterilization nsuo nni dwuma efisɛ eyinom betumi asɛe nneɛma a wɔde kata so no. Wɔde IFU (Akwankyerɛ a Wɔde Di Dwuma) a edi mũ a ɛkyerɛkyerɛ sterilization protocols mu kɔ akyiri ka nneɛma biara a wɔde kyekyere nneɛma ho.

XC Medico de Ti-6Al-4V ELI (Extra-Low Interstitial) Grade 23 di dwuma wɔ ASTM F136 biara mu, aduruyɛ-grade gyinapɛn no. Nneɛma atitiriw: Tensile ahoɔden ≥860 MPa , aba ahoɔden ≥795 MPa, elongation ≥10%. Nneɛma a wɔde yɛ aduru no yɛ 90% Titanium, 6% Aluminium, 4% Vanadium. Nnompe mprɛte ne nkɔnsɔnkɔnsɔn fa Type II anodization soro ayaresa mu de ma nnompe a ɛko tia ne nnompe a ɛka bom yɛ kɛse. Saa alloy yi yɛ MRI-conditional wɔ 1.5T ne 3T a scan tebea pɔtee bi a wɔakyerɛkyerɛ mu kɔ akyiri wɔ product labeling mu.

Wɔakyekyɛ XC Medico a wɔde Titanium ayɛ nyinaa mu sɛ MR Conditional sɛnea ASTM F2503 kyerɛ no. Wɔyɛ ahotɔ wɔ 1.5T ne 3.0T afuw mu ahoɔden a ɛwɔ ahunmu a ɛkɔ soro sen biara a ɛyɛ 720 G/cm. Stainless steel implants (316L) nso yɛ MR Conditional nanso ebetumi ama mfonini akɛse ayɛ artifacts; wo ne oduruyɛfo a ɔhwɛ mframa so no nyɛ biako. Mma nyɛ MRI wɔ adapɛn 6 akyi wɔ bere a wɔde ahyɛ nipadua no mu no mu gye sɛ ɛho hia ntɛm wɔ ayaresabea. Wɔde SAR (Specific Absorption Rate) anohyeto pɔtee ne gyinabea anohyeto ahorow ama wɔ ankorankoro nneɛma IFU nkrataa a ɛwɔ Resource Center a ɛwɔ atifi hɔ no mu.

Torques a etwa to a wɔkamfo kyerɛ sɛ wɔde hyɛ mu den no gu ahorow sɛnea skru no kɛse te: 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: 3.5–4.0 Nm . Bere nyinaa fa calibrated torque-limiting screwdriver di dwuma na ntra torque a ɛsen biara da na woakwati sɛ wobɛyi locking mechanism no anaasɛ cold-welding. Sɛ wote nsaano ahoɔden nka bere a wode hyɛ mu ansa na woadu bun a etwa to a, gyina na fa drill guide sleeve a ɛfata no hwɛ sɛ drill tokuru no kɛse yɛ nokware. Sripped locking screws hia kit soronko bi a wɔde yi fi hɔ a wobetumi anya wɔ ɔkwan soronko so.

XC Medico a wɔde hyɛ nipadua mu a ɛwɔ nneɛma a wɔde ahyɛ mu a enni dɛm mu no wɔ mfe 5 fi da a wɔyɛɛ no ​​(hwɛ nkyerɛwde no so). Tebea a wɔkora so: ɔhyew +5°C kosi +30°C , nsu a ɛyɛ nwini 15–85% a ɛnyɛ nea ɛyɛ nwini , a ɛwɔ akyirikyiri fi owia hann tẽẽ ne nnuru a ɛporɔw ho. Ɛsɛ sɛ wɔde nneɛma biara a wɔde kyekyere nneɛma a ɛkyerɛ sɛ wɔatow, nsu, anaa nhyɛso a asɛe no to nkyɛn na wɔmfa nni dwuma. PEEK ne resorbable components betumi anya shelf nkwa nna tiaa (mpɛn pii no mfe 3) — bere nyinaa hwɛ ankorankoro ade no nkyerɛwde. Ɛsɛ sɛ wɔhwɛ trackability records (lot number, expiry, patient use) so sɛdeɛ mpɔtam hɔ MDR mmara teɛ.

XC Medico wɔ adansedie a ɛdidi soɔ yi: ISO 13485:2016 (Quality Management System), CE Marking wɔ EU MDR 2017/745 (Class IIb), ne CFDA / NMPA din a wɔakyerɛw ama China gua so. Nneɛma a wɔde rekɔ gua pɔtee bi so no betumi de mpɔtam hɔ pene foforo — hwehwɛ wo mpɔtam hɔ adetɔn nkitahodi no mu. OEM ahokafoɔ bɛtumi abisa akontabuo amanneɛbɔ ne Mpaemuka a ɛfa Nhyiamu ho nkrataa afiri yɛn Mmarahyɛ Nsɛm kuo no hɔ. Mprempren yenni FDA 510(k) tumi krataa a ɛma U.S. gua so; yɛsrɛ sɛ si so dua sɛ wofata wɔ gua so ansa na woakra nneɛma a wɔde kɔ U.S.