ʻO nā ʻōnaehana laser Fiber, UV, a me MOPA e hoʻokō ana i nā koi mau loa a me ka maʻemaʻe o ka hana ʻana i nā mea lapaʻau - me ka ʻole o ke kumukūʻai ʻoihana.
No ke aha e neʻe ai ka ʻoihana lapaʻau i ka hana laser
He pilikia maʻalahi ka hana ʻana i ke kālai ʻana i ka mīkini a me ka māka ʻīnika i ka hana lapaʻau: hōʻino lākou i ka substrate, hoʻokomo i ka haumia, a mae paha ma lalo o nā pōʻaiapuni sterilization hou. I loko o kahi ʻano hana kahi e hele ai kahi implant ʻoki kino a i ʻole kahi mea hana hou e hele i nā pōʻaiapuni autoclave, disinfection kemika, a i ʻole ka irradiation gamma, ʻaʻole ʻae ʻia kekahi o nā hopena.
Hoʻoponopono ka hana laser i nā pilikia ʻelua i ka manawa hoʻokahi. Hoʻopili wale ke kukuna i nā photons me ka workpiece - ʻaʻohe mea ʻoki e pau a waiho i nā ʻōpala metala, ʻaʻohe ʻīnika e neʻe i loko o nā māwae o ka ʻili. ʻO nā māka e hana ai he mea koʻikoʻi ia i ka mea ponoʻī, ʻaʻole kahi uhi e kau ana ma luna.
Ma ke ʻano he kānāwai maʻamau, inā koi kahi kikoʻī huahana i kahi māka e ola ana ma mua o 1,000 mau pōʻaiapuni autoclave ma 134 °C (273 °F), ʻo ka laser wale nō ke ʻano hana ʻole e luku ai e hāʻawi pono ai. ʻO nā kaʻina hana hoʻokūkū - electrochemical etching, pad printing, dot-peen - hāʻule kēlā me kēia i kekahi o nā pae hoʻohālikelike ʻekolu: mau loa, maʻemaʻe, a i ʻole ka pono o ka substrate.
ʻO nā koi hana ʻekolu e pono ai
- KA PAʻA MAU
Pono ka māka e ola i ka sterilization, nā mea hoʻomaʻemaʻe, a me ka lawelawe mechanical ma ke ola lawelawe o ka hāmeʻa. ʻAʻole hōʻike nā māka i hoʻoheheʻe ʻia me ka laser a i ʻole ka laser-ablated ma ke kila kila a me ka titanium i ka hōʻino ʻana ma hope o ka hoʻāʻo ʻana i ka sterilization mahu. - KA MAʻEMAʻE
ʻAʻohe haumia lua. He hana maloʻo ka māka ʻana o ka laser, ʻaʻohe pili me ka ʻole o nā mea hoʻopau e hoʻopā ana i ka ʻāpana. Hoʻoponopono ka hoʻokaʻawale ʻana i ka uahi i kekahi mea mahu, e waiho ana i kahi ʻili i mākaukau no ka passivation me ka ʻole o nā hana hoʻomaʻemaʻe hou. - KŪPONO
ʻO ke kiʻekiʻe haʻahaʻa loa o nā huapalapala no kahi code DataMatrix hiki ke heluhelu ʻia e nā scanner 2D maʻamau he 0.3 mm (0.012 in). Mālama nā ʻōnaehana laser MimoWork galvo i kahi pololei hoʻonohonoho hou e kākoʻo ana i nā kiʻekiʻe huapalapala a hiki i ka 0.01 mm (0.0004 in), aia ma loko o kēlā paepae.
Nā Kaʻina Hana Laser Kākoʻo MimoWork
ʻAʻole kūpono nā kaʻina hana laser āpau no kēlā me kēia ʻano hāmeʻa. ʻO nā hiki koʻikoʻi ʻekolu i uhi ʻia e nā ʻōnaehana MimoWork i loko o kahi ʻano hana lapaʻau, ʻo ia ka māka ʻana, ka kuʻi ʻana, a me ka ʻoki ʻana - kēlā me kēia me nā koi kumu laser like ʻole.
Ka Māka ʻana i ka Laser (Fiber / UV / MOPA)
ʻO kēia ka noi nui loa. Pono ke kaha kiʻi hoʻoponopono - ʻo ia hoʻi nā code UDI ma lalo o FDA 21 CFR Māhele 830 a me EU MDR Article 27 - i kahi māka mau loa, hiki ke heluhelu ʻia e ka mīkini ma ka hāmeʻa a i ʻole kāna ʻōpala. ʻO ka māka laser ke ʻano hana nui no kēia koi.
ʻO ke ʻano laser kūpono e pili ana i ka substrate:
| ʻAno Laser | Ka lōʻihi o ka nalu | ʻOi loa no (Lapaʻau) | Ka ʻĀpana i Hoʻopilikia ʻia e ka Wela |
|---|---|---|---|
| ʻO ke olonā (maʻamau) | 1064 nm | Nā mea hana kila kila, nā ʻāpana alumini | Waena |
| ʻO ke kaula MOPA | 1064 nm | Nā mea hoʻokomo Titanium, nā ʻili anodized | Haʻahaʻa - ʻoi aku ka maikaʻi ma nā paia lahilahi |
| UV | 355 nm | PEEK, nā catheters polymeric, nā hale palekana wela | Minimal - ke kaʻina hana anu |
Puna: Nā kikoʻī o ka mīkini MimoWork.
Hoʻomaopopo ʻenekinia — MOPA vs. Fiber Maʻamau
I loko o kahi ʻano hana, ʻo ka ʻokoʻa maoli ma waena o MOPA a me ka fiber maʻamau e pili ana i ka mana pulse. Hoʻā ka laser fiber pulsed maʻamau i kahi laulā pulse paʻa. Hiki iā MOPA ke hoʻonohonoho i ka laulā pulse (maʻamau 2-500 ns) a me ka helu hana hou kūʻokoʻa. Ma ka titanium Grade-5 (Ti-6Al-4V) - ka alloy i hoʻohana ʻia i ka hapa nui o nā wili iwi a me nā pani hui - ʻo ka laulā pulse haiki o kahi ʻōnaehana MOPA e hōʻemi ana i ka pilikia micro-cracking ma ka palena māka i hoʻohālikelike ʻia me kahi fiber maʻamau e holo ana ma ka mana awelika like. He mea nui kēia i ka wā e hōʻailona ai i nā ʻāpana implant paia lahilahi kahi e lilo ai kekahi kaumaha ma lalo o ka ʻili i mea hōʻole.
Kuʻihao Laser (100W–3000W)
Hoʻohana nui ka ʻākoakoa ʻana o nā mea lapaʻau i ka wili laser ma kahi o ka wili pale a i ʻole ka hoʻopili ʻana i ka pipili. ʻO ka pōmaikaʻi nui ma kēia ʻano, ʻo ia ka ʻāpana haiki i hoʻopilikia ʻia e ka wela (HAZ): kahi wili laser i hoʻonohonoho pono ʻia ma ka waihona paipu kila kila 316L e waiho ana i kahi hui i hoʻopili ʻia me ka ʻole o ka hoʻopilikia ʻana i ke ʻano hoʻopuni, he mea nui ia no nā mea kani me nā hoʻomanawanui dimensional paʻa.
Uhi nā mea hoʻoheheʻe laser fiber lima ʻo MimoWork i ka mānoanoa o ka hoʻoheheʻe ʻaoʻao hoʻokahi mai 0.5 mm (0.020 in) ma 500W a hiki i 3.0 mm (0.118 in) ma 2000W ma ke kila kila. Kākoʻo ʻia hoʻi ka titanium alloy ma waena o ka mana. ʻO ka manawa pōʻaiapuni no ka hoʻoheheʻe humuhumu maʻalahi ma kahi hale mea kani liʻiliʻi he 2-10 × wikiwiki ma mua o ka hoʻoheheʻe TIG, me ka emi iki o ka hoʻopau ʻana ma hope o ka hoʻoheheʻe ʻana no ka mea he pālahalaha a ʻoi aku ka kūlike o ke ʻano bead.
| Mana | Hohonu ʻaoʻao hoʻokahi SS | Hohonu ʻaoʻao hoʻokahi alumini | ʻO ka titanium |
|---|---|---|---|
| 500W | 0.5 mm (0.020") | — (ʻaʻole i ʻōlelo ʻia) | Kākoʻo ʻia |
| 1000W | 1.5 mm (0.059") | 1.2 mm (0.047") | Kākoʻo ʻia |
| 1500W | 2.0 mm (0.079") | 1.5 mm (0.059") | Kākoʻo ʻia |
| 2000W | 3.0 mm (0.118") | 2.5 mm (0.098") | Kākoʻo ʻia |
Puna: Nā kikoʻī o ka mīkini MimoWork.
ʻOki ʻana i ka laser
No nā mea hana mea lapaʻau e ʻokiʻoki ana i ke kila kila a i ʻole ka pepa titanium i loko o nā ʻāpana hakahaka - nā cannulae, nā lima mea hana, nā seti hoʻāʻo implant - hoʻopau ka ʻoki laser i ke kumukūʻai mea hana a me ka manawa alakaʻi e pili ana i nā make stamping. ʻAʻohe nui kauoha liʻiliʻi loa, kahi e kūpono i ka nui hana haʻahaʻa a waena i maʻamau i nā orthopedics a me nā mea hana ʻoki.
Ma ke ʻano he kānāwai maʻamau, lilo ka ʻoki laser i mea hoʻokūkū kumukūʻai me ka hoʻopaʻa ʻana ma nā holo ma lalo o 5,000 mau ʻāpana i kēlā me kēia makahiki no nā ʻāpana ma lalo o 3 mm (0.118 in) ka mānoanoa, ke noʻonoʻo ʻia ka amortization tooling. Ma luna o kēlā paepae, lanakila ka hoʻopaʻa ʻana ma ka manawa pōʻaiapuni. No ka prototyping a me ka hana liʻiliʻi - ka mea e wehewehe ana i ka hapa nui o nā mea hana lapaʻau SME - ʻo ka ʻoki laser ka paʻamau.
E hoʻouna i kāu kūpona ʻāpana a mea paha i ka hale hoʻokolohua MimoWork. E holo mākou i nā hoʻokolohua māka a hoʻihoʻi i kahi hōʻike hoʻāʻo me nā palena i ʻōlelo ʻia - ʻaʻohe koi kūʻai.
Nā Mea i Kākoʻo ʻia no ka Hana ʻana i nā Hāmeʻa Lapaʻau
Uhi ʻia nā mea ma lalo nei e nā hoʻonohonoho mīkini maʻamau a MimoWork a me ka lawelawe hoʻāʻo mea. Inā ʻaʻole i helu ʻia kāu substrate, hiki i ka hui Hoʻāʻo Mea ke holo i kahi loiloi laʻana ma mua o kou hoʻohiki ʻana i kahi kūʻai.
| Mea Hana | Ka Hoʻohana ʻana i nā Hāmeʻa Maʻamau | Kaʻina Hana i Manaʻo ʻia | Puna Laser |
|---|---|---|---|
| 316L kila kila | Nā mea hana ʻoki kino, nā pā mea hana, nā hale | Māka hoʻoheheʻe, kuʻihao | ʻO ke olonā / MOPA |
| Ti-6Al-4V (Pae 5 Titanium) | Nā wili iwi, nā papa, nā pani hono, nā mea hoʻokomo niho | Māka hoʻoheheʻe (makemake ʻia ʻo MOPA) | ʻO ke kaula MOPA |
| ʻO ka hui alumini | Nā hale o nā hāmeʻa, nā pā i hiki ʻole ke hoʻokomo ʻia | Māka anodizing ʻeleʻele, kuʻihao | MOPA / Fiber |
| Nānā | Nā mea hoʻokomo iwi kuamoʻo, nā mea hana hoʻāʻo | Ka māka anu (ka hoʻopau ʻana i ka ʻili) | UV (355 nm) |
| Polycarbonate / ABS | Nā hale o nā hāmeʻa, nā ʻāpana hoʻolei ʻia, nā lako hana diagnostic | Kaha anu | UV (355 nm) |
| Nā Polymers Silicone / Flexible | Nā kino catheter, nā sila, nā paʻa lima | Ka māka ʻili - e kelepona mai iā mākou e hoʻāʻo; ʻokoʻa nā hopena ma muli o ke ʻano hana | UV — koi ʻia ka hoʻāʻo laʻana |
Puna: Nā kikoʻī o ka mīkini MimoWork.
Ka hiki ke māka UDI
ʻO ka ʻōnaehana ʻIke Mea Hana Kūikawā (UDI) a ka FDA — i hoʻokumu ʻia ma lalo o 21 CFR Māhele 830 — a me ke koi like o ka EU MDR Article 27 e koi ana i ka hapa nui o nā mea lapaʻau e lawe i kahi hōʻike kū hoʻokahi hiki ke heluhelu ʻia e ka mīkini. No nā mea hana i hoʻomaʻemaʻe ʻia a hana hou ʻia paha, pono ka UDI e ola i kēlā mau pōʻaiapuni ma ka mea hana ponoʻī, ʻaʻole wale ma ka lepili.
ʻO ka māka laser ka hopena kūpono no kēia koi ke hana ʻia ka hāmeʻa metala a i ʻole i hana ʻia mai nā polymers e kūlike me ka laser. ʻO nā ʻano code kikoʻī e pono ai:
• 2D DataMatrix — ke ʻano nui no ka māka ʻāpana pololei (DPM) ma nā mea lapaʻau metala
• QR Code — hoʻohana nui ʻia ma nā ʻōpala a me nā lepili hāmeʻa
• Nā barcode linear (GS1-128, Code 128) — koi ʻia nō ma kekahi mau laina huahana kahiko
ʻO nā ʻōnaehana laser MimoWork fiber a me UV, i kāohi ʻia ma o ka polokalamu EzCAD, hiki ke hana a hōʻailona i nā ʻano ʻekolu pololei mai ka ʻikepili hana. Kākoʻo ka ʻōnaehana scan galvo i ka pololei o ke kūlana hana hou e lawa ai e hana i kahi cell DataMatrix 10 × 10 ma ka nui o ka module 0.3 mm (0.012 in) - ka palena iki no ka heluhelu ʻana i ka scanner hilinaʻi i loko o kahi ʻano lapaʻau.
ʻŌlelo Hoʻomaopopo Hiki - ʻAʻole ia he Koi Hoʻokō
Ua hoʻopaʻa inoa ʻia nā mīkini laser MimoWork me CE a ua hoʻopaʻa inoa ʻia me FDA ma ke ʻano he lako laser. ʻO ke ʻano kēia, ua hoʻokō nā mīkini i nā kūlana palekana laser a me ka hoʻohālikelike electromagnetic no ke kūʻai aku a me ka hana ma nā mākeke US a me EU.
ʻAʻole ia manaʻo e hōʻoia ana ʻo MimoWork ua kūlike kāu hāmeʻa i hoʻopau ʻia me ka FDA UDI, ISO 13485, a i ʻole kekahi kūlana hoʻoponopono hāmeʻa lapaʻau ʻē aʻe - aia kēlā hoʻoholo i kāu hui hoʻoponopono a me ke kino i hoʻomaopopo ʻia. ʻO ka mea hiki iā mākou ke hōʻoia, ʻo ia ka hiki i nā ʻōnaehana laser ke hana i ka maikaʻi māka e pono ai kēlā mau kūlana. Inā makemake ʻoe i ka ʻikepili paʻa māka a i ʻole nā māka laʻana no ka palapala hōʻoia, hiki i ka lawelawe Hoʻāʻo Mea ke hana iā lākou.
No ke aha e koho ai nā mea hana SME iā MimoWork
Lawelawe nā mea kūʻai aku laser ʻoihana i nā ʻoihana. Holo kā lākou mau pōʻaiapuni kūʻai aku he 6-12 mau mahina, ua uku ʻia kā lākou hoʻonohonoho liʻiliʻi loa, a ua hoʻokaʻawale mua ʻia kā lākou mau ʻenekinia noi i kā lākou moʻokāki nui loa. No kahi mea hana mea lapaʻau e holo ana i 10-50 mau kānaka, ʻaʻole kūpono kēlā ʻike kūʻai.
Ua hoʻolālā a kūkulu ʻo MimoWork i nā ʻōnaehana laser no 20 mau makahiki. Uhi ka laulā huahana i ka papa hana piha - ka māka ʻana, ka hoʻoheheʻe ʻana, ka ʻoki ʻana, ka hoʻomaʻemaʻe ʻana - ma nā hoʻonohonoho i hoʻonohonoho ʻia i ka nui kino a me ke kumukūʻai no ka hale hana a me nā wahi hana liʻiliʻi, ʻaʻole 10,000 sq ft Class-10 lumi maʻemaʻe.
Nā nīnau i nīnau pinepine ʻia
ʻAe. Kākoʻo nā mīkini māka laser fiber MimoWork MOPA i ka 2D DataMatrix, nā code QR, a me nā barcode linear ma ka titanium Ti-6Al-4V (Grade 5) ma nā nui module a hiki i ka 0.3 mm (0.012 in) - ʻo ka palena iki e pono ai no ka heluhelu ʻana o ka scanner hilinaʻi i nā wahi lapaʻau. Hiki ke hoʻololi kūʻokoʻa ʻia ka laulā pulse MOPA (2-500 ns), kahi e hōʻemi ai i ka ʻāpana i hoʻopilikia ʻia e ka wela ma nā ʻāpana implant paia lahilahi i hoʻohālikelike ʻia me nā laser fiber maʻamau. Ua hoʻopaʻa inoa ʻia nā mīkini ponoʻī me CE a ua hoʻopaʻa inoa ʻia me FDA ma ke ʻano he lako laser.
ʻO ka laser UV (355 nm) ke koho kūpono no PEEK a me nā polymers ʻenekinia ʻē aʻe. Hana ka māka UV ma o kahi kaʻina hana photochemical - uhaʻi ia i nā pilina molekala me ka ʻole o ka hoʻomehana nui, ʻo ia hoʻi, ʻaʻohe deformation thermal a i ʻole keʻokeʻo stress ma luna o nā mea a puni. Hana nā lasers fiber ma 1064 nm a waiho nui i ka wela ma kēlā me kēia pulse, hiki ke hana i ka heheʻe kūloko a i ʻole ka discoloration ma nā substrates polymer. Inā ʻaʻole ʻoe maopopo inā e hana ka māka UV i ka ʻokoʻa lawa ma kāu formulation PEEK kikoʻī, e hoʻouna i kahi laʻana i ka lab hoʻāʻo mea o MimoWork ma mua o ka kuhikuhi ʻana i kahi ʻōnaehana.
ʻO nā māka i hoʻoheheʻe ʻia me ka laser a me ka laser-ablated ma ke kila kila a me ka titanium he mea koʻikoʻi ia i ka mea kumu - ʻaʻole lākou he uhi a mea hoʻohui paha ma luna o ka ʻili. Ma ke ʻano he kānāwai maʻamau, ʻo nā māka i hana ʻia ma ke kila kila 316L a me Ti-6Al-4V me ka hoʻohana ʻana i ka fiber a i ʻole ka laser MOPA e hōʻike i ka hōʻino ʻana ma hope o ka sterilization mahu ma 134 °C (273 °F). Inā koi kāu protocol hōʻoia i ka ʻikepili paʻa māka i palapala ʻia, hiki iā MimoWork ke hana i nā coupons hōʻailona laʻana ma o ka lawelawe hoʻāʻo mea hiki iā ʻoe ke waiho no ka hoʻāʻo kūʻokoʻa.
Hāʻawi ʻo MimoWork i nā palapala hoʻopaʻa inoa CE a me nā palapala hoʻopaʻa inoa FDA no kēlā me kēia mīkini i ka wā kūʻai - ʻo ia mau mea ʻelua e pono pinepine ʻia i ka wā e hoʻopaʻa inoa ai i nā lako i loko o kahi ʻōnaehana hoʻokele maikaʻi o nā hāmeʻa lapaʻau. Hiki i ka lawelawe hoʻāʻo mea ke hana i nā hōʻike hoʻāʻo e hōʻike ana i nā palena māka (mana, wikiwiki, alapine) a me nā hopena laʻana, hiki ke kākoʻo i kāu mau moʻolelo hōʻoia kaʻina hana. ʻAʻole paʻa ʻo MimoWork i ka palapala hōʻoia ISO 13485 ma ke ʻano he mea hana lako laser; uhi ka palapala i hāʻawi ʻia i nā lako ponoʻī, ʻaʻole kāu hāmeʻa i hoʻopau ʻia.
I loko o kahi ʻano hana, ʻo ka manawa pōʻaiapuni no hoʻokahi code DataMatrix ma kahi ʻili kila kila pālahalaha e holo ana ma kahi o 1-3 kekona me ka hoʻohana ʻana i kahi māka laser fiber MimoWork galvo, ma muli o ka nui o ke code a me ka nui o ke kelepona. Inā pono kāu ʻāpana e hoʻololi hou ʻia a i ʻole he ʻili piʻo e pono ai kahi mea hoʻopaʻa wili, e ʻae i ka manawa lawelawe hou aku. No ka māka nui o nā pā mea kani a i ʻole nā ʻāpana batch, e kelepona i kahi loea noi MimoWork me kāu geometry ʻāpana kikoʻī a me ka nui makahiki - ʻoi aku ka pololei o nā kuhi manawa pōʻaiapuni ke kau ʻia ma kāu ʻāpana hana maoli.
Ua mākaukau e hōʻoia i kāu kaʻina hana māka UDI?
Ka manawa hoʻouna: Malaki-20-2026