Kev Txawj Ntse Technologytshaj tawm tias nws tag nrho ntawm Menchini daim siab biopsy koob tau ua tiav qhov kev tshuaj xyuas nruj ntawm EU Kev Tswj Xyuas Khoom Siv Khomob tshiab (MDR) thiab tau txais daim ntawv pov thawj dual ntawm ISO 9001: 2015 thiab ISO 13485: 2016 kev tswj xyuas zoo raws li "zero defect" tswvyim. Daim ntawv tshaj tawm kev tshuaj xyuas tshwj xeeb tau qhuas nws tag nrho - txheej txheem digital traceability system los ntawm cov khoom siv raw nkag mus rau cov khoom xa tuaj tiav, nrog rau cov kev huv huv huv uas coj los ntawm electrolytic polishing thiab ntau - theem ultrasonic tu txheej txheem. Cov txheej txheem no ua kom ntseeg tau tias qhov kev tiv thaiv tseem ceeb ntawm txhua rab koob txhaj tshuaj tawm hauv lub Hoobkas raug tswj tsis pub dhau ± 5 micrometers, thiab cov khoom siv roj ntsha tsawg dua li cov qauv kev lag luam los ntawm ib qho kev txiav txim ntawm qhov loj, ua tiav qhov kawg ntawm cov qauv kev ntseeg tau ntawm cov khoom.

Kev tshawb nrhiav thiab kev txhim kho keeb kwm yav dhau thiab cov teeb meem

Lub siab biopsy, raws li tus txheej txheem invasive, kev ntseeg siab ntawm cov cuab yeej ncaj qha cuam tshuam rau tus neeg mob kev nyab xeeb. Raws li cov qauv kev tsim khoom ib txwm muaj, kev pheej hmoo zoo tau muab zais hauv txhua kauj ruam:

Supply chain fluctuation risk:Qhov sib txawv me me ntawm cov ntsiab lus tseem ceeb thiab cov nplej loj ntawm cov khoom sib txawv ntawm cov khoom siv raw tuaj yeem ua rau qhov kev hloov pauv tsis txaus ntseeg hauv kev ua haujlwm ntawm cov khoom kawg;

Txheej txheem tswj qhov muag tsis pom kev:Kev soj ntsuam zoo ib txwm nyob ntawm kev ua piv txwv, uas tsis tuaj yeem ua kom muaj qhov sib xws ntawm txhua yam khoom, tshwj xeeb tshaj yog rau qhov tseem ceeb tab sis nyuaj - rau - ntsuas qhov ntsuas xws li lub microscopic geometric duab ntawm lub koob taub thiab kev huv ntawm lub puab kab noj hniav;

Kev nyab xeeb kev nyab xeeb:Cov roj ua cov khoom seem, cov khib nyiab hlau, lossis cov tshuaj ntxuav, yog nqa los ntawm rab koob mus rau hauv tib neeg lub cev, tuaj yeem ua rau muaj kev mob tshwm sim, cuam tshuam rau kev txiav txim siab, thiab tseem ua rau muaj kab mob;

Traceability nyuaj:Nyob rau hauv qhov kev tshwm sim tsis zoo, nws yog ib qho nyuaj rau sai thiab meej nrhiav qhov teeb meem batch thiab cov txheej txheem ntau lawm, uas yog tsis conducive rau kev pheej hmoo ntawm kev tswj.

Core Technological Innovation

Cov chaw tsim khoom tau tsim ib qho "digital quality kaw-loop" system uas npog tag nrho lub neej voj voog:

Raw khoom traceability raws li blockchain:Tsim kom muaj tus lej cim digital tshwj xeeb rau txhua yam ntaub ntawv, tshwj xeeb tshaj yog cov hlau tseem ceeb uas suav nrog "Bill of Materials (BOM)". Cov cai no txuas tag nrho cov ntaub ntawv los ntawm steel zeb melting tooj, tshuaj muaj pes tsawg leeg daim ntawv qhia, mechanical kev ua tau zoo daim ntawv pov thawj rau cov ntaub ntawv ntawm txhua batch's nyob rau hauv -warehouse soj ntsuam, thiab uploads mus rau ib tug private blockchain los xyuas kom meej tias cov ntaub ntawv yog immutable thiab tag nrho traceable.

Kev tshuaj xyuas tsis siv neeg hauv online thiab kev tswj cov txheej txheem:Kev sib koom ua ke ntawm lub tshuab tsis pom kev thiab laser profileometers ntawm cov haujlwm tseem ceeb ntawm cov kab ntau lawm (xws li tom qab laser txiav thiab polishing), ua 100% kev tshuaj xyuas online ntawm cov kab sab nraud, sab hauv txoj kab uas hla, koob lub kaum ntse ntse, thiab txiav ntug tsis xws luag ntawm txhua rab koob. Cov ntaub ntawv yog uploaded nyob rau hauv lub sij hawm ntawm lub sij hawm mus rau lub manufacturing execution system. Ib qho kev sib txawv dhau qhov kev tswj xyuas cov txheej txheem txheeb cais (SPC) yuav ua rau lub tswb tsis siv neeg thiab cais cov khoom.

Ntau-qib huv huv thiab kev kuaj xyuas kev huv:Tsim kom muaj ib txoj kab tu automated nrog cov txheej txheem ntawm "tshuaj degreasing - electrolytic polishing - multi-frequency ultrasonic tu - ultra- dej ntshiab huv - nqus tsev vacuum drying". Electrolytic polishing tsis tsuas yog tshem tawm cov burrs ntawm microscopic thiab smoothens lub sab hauv phab ntsa, tab sis kuj tsim ib tug niaj hnub passivation zaj duab xis uas txhim kho corrosion kuj. Cov tom ntej multi- zaus ultrasonic tu siv cov nyhuv cavitation ntawm ntau zaus kom huv si tshem tawm cov kab mob adhering rau cov kab noj hniav complex nyob rau hauv cov ces kaum. Kev huv huv raug txheeb xyuas los ntawm peb txoj kev: suav particle, kuaj pom endotoxin, thiab tag nrho cov organic carbon tsom xam.

Mechanism ntawm Action

Qhov kev ua tau zoo no ua kom muaj kev ntseeg siab los ntawm cov txheej txheem ntawm "kev tiv thaiv ua ntej, tag nrho- txheej txheem tswj, thiab cov ntaub ntawv- tsav mus kom ze":

Blockchain traceability ntsuas qhov zoo ntawm cov hauv paus ntsiab lus, hloov lub "black box" ntawm raw cov ntaub ntawv mus rau hauv "dawb lub thawv". Ib qho kev hloov pauv ntawm kev ua haujlwm tom qab tuaj yeem taug qab mus rau cov khoom siv batch, ua rau kev tshawb fawb hauv paus.

100% kev sim online hloov pauv cov qauv tshuaj ntsuam xyuas ib txwm, tshem tawm qhov kev pheej hmoo ntawm "cov khoom tsis raug cuam tshuam los ntawm net". Nws yog sib npaug los tsim kom tiav "cov ntaub ntawv yug" rau txhua koob, nrog rau nws cov ntaub ntawv loj khi rau tus lej xov tooj. Nyob rau hauv lub neej yav tom ntej, nws tuaj yeem cuam tshuam nrog kev ua haujlwm kho mob los ntawm kev txheeb xyuas cov ntaub ntawv loj.

Kev sib koom ua ke ntawm electrolytic polishing thiab ultrasonic tu tsim ib qho ultra- huv si ntawm lub cev thiab tshuaj. Cov chromium-enriched passivation txheej tsim los ntawm electrolytic polishing tuaj yeem tiv thaiv kev tsim ntawm biofilms. Nyob rau hauv ntau- zaus ultrasonic tu txheej txheem, qhov tsawg zaus (20-}40kHz) tsim lub zog loj cavitation npuas rau kev tshem tawm cov kab mob loj, thaum lub siab zaus (80-200kHz) tsim cov npuas me me cavitation ua npuas ncauj rau kev ntxuav sub-micron particles.

Kev txheeb xyuas qhov ua tau zoo

Qhov kev ua tau zoo no tau dhau los ua pov thawj sab hauv thiab ntau yam ntawm - kev tshuaj xyuas qhov chaw los ntawm thib peb -cov ntawv pov thawj tog.

Dimension kev tsom xam:Kev ntsuas qhov ntsuas tseem ceeb tau ua rau ntawm 10,000 koob tsim ua ntu zus. Cov txheej txheem suav cov peev txheej ntsuas Cpk qhov tseem ceeb yog tag nrho ntau dua 2.0, qhia tias cov txheej txheem tau ruaj khov thiab cov khoom tawg tau qis heev.

Cleanliness limit test: According to the ISO 19227 (cleanliness standard for surgical implants) standard, the count results of particles (>10μm) nyob rau hauv lub puab kab noj hniav ntawm cov tshuaj ntxuav tau zoo dua rau cov qauv yuav tsum tau, thiab cov ntsiab lus endotoxin yog qis dua qhov kev kuaj pom ntawm 0.01 EU / mL.

Clinical tawm tswv yim thiab traceability ce:Hauv kev simulated cov khoom lag luam rov qab ua haujlwm, siv cov txheej txheem digital, tag nrho cov ntaub ntawv tsim khoom, cov khoom siv raw khoom, thiab cov khoom muag ntawm cov khoom lag luam tsis zoo tuaj yeem txheeb xyuas qhov tseeb hauv 15 feeb. Thaum lub sij hawm siv tshuaj kho mob tiag tiag, tsis muaj qhov tshwm sim tsis zoo uas cuam tshuam txog kev tsim khoom tsis raug tshwm sim hauv peb xyoos.

Kev tshawb fawb thiab kev loj hlob Strategy thiab Philosophy

Manas TechnologyLub tswv yim zoo yog "Tshaj li kev ua raws, nrhiav kev ntseeg siab kawg". Lawv ntseeg tias ua tau raws li cov qauv ISO tsuas yog qhov yuav tsum tau muaj tsawg kawg nkaus; Lub hom phiaj tiag tiag yog kom ua tiav qib zoo ntawm Six Sigma (6σ) ntawm cov kab ntau lawm uas tsis muaj kev cuam tshuam tib neeg. Lawv lub tswv yim tseem ceeb yog "Zoo yog tsim thiab tsim, tsis raug tshuaj xyuas." Yog li ntawd, lawv tau nqis peev ntau ntawm cov peev txheej hauv kev tiv thaiv kev ua haujlwm zoo, xws li siv txoj kev Taguchi txhawm rau txhim kho qhov ua tau zoo ntawm cov txheej txheem tsis ua haujlwm thiab siv Kev Ua Haujlwm Tsis Ua Haujlwm thiab Kev Ntsuam Xyuas Cov Teebmeem (FMEA) txhawm rau txheeb xyuas cov ntsiab lus pheej hmoo ua ntej. Lub tuam tsev zoo tsis yog qhov kawg "tus neeg saib xyuas", tab sis yog "tus tsim" thiab "tus kws qhia" thoob plaws tag nrho cov txheej txheem ntawm kev tshawb fawb thiab kev tsim kho thiab tsim khoom.

Yav tom ntej Outlook

Cov txheej txheem zoo yav tom ntej yuav hloov mus rau "kev kwv yees zoo" thiab "kev tsim kho kom haum". Cov neeg tsim khoom siv "Industrial Internet of Things platforms" los txuas txhua yam khoom siv thiab txhua lub sensor ntawm cov kab ntau lawm. Los ntawm kev txheeb xyuas qhov tseeb tiag - cov ntaub ntawv tsim tawm lub sijhawm los ntawm kev kawm tshuab algorithms, lub kaw lus tuaj yeem kwv yees cov xwm txheej xws li cov cuab yeej hnav, lub zog laser attenuation, lossis kev poob qis hauv kev ua haujlwm ntawm cov kua dej, thiab tuaj yeem ua rau kev kho lossis kev hloov pauv ua ntej lawv cuam tshuam cov khoom lag luam. Tsis tas li ntawd, los ntawm kev sib txuas cov ntaub ntawv kho mob loj, yav tom ntej, nws yuav ua tiav "tus txheej txheem nws tus kheej- kev ua kom zoo raws li cov txiaj ntsig kev kho mob": yog tias ib pawg ntawm cov khoom tau qhia me ntsis txo qis hauv cov ntaub so ntswg tau txais tus nqi hauv ntau lub tsev kho mob, lub kaw lus tuaj yeem txheeb xyuas cov ntaub ntawv tsim tawm ntawm cov khoom siv ntawd, txheeb xyuas cov txheej txheem kev tsim cov khoom lag luam, thiab cov txheej txheem kev teeb tsa muaj feem cuam tshuam, voj los ntawm kev kho mob daim ntawv thov mus rau kev tsim khoom, tsis tu ncua kev txhim kho cov khoom ua tau zoo.