Sukurin aminci na endoscopic da aka yi a Amurka

Sukurin aminci na endoscopic da aka yi a Amurka

 

Ansix Fasahar Kayan Aikin Lafiya ta Cikin Gida tare da Sukurori Masu Tsaro Masu Daidaitawa don Endoscopic Staplers

A wannan zamani da juriyar sarkar samar da kayayyaki da masana'antu a cikin gida ke da matuƙar muhimmanci ga muhimman sassan kiwon lafiya, wani ƙwararren mai yin allurar allura yana yin rawar jiki. Ansix Tech, wani kamfani mai takardar shaidar ISO 13485:2016, ya yi nasarar ƙirƙiro kuma ya ƙaddamar da cikakken sikelin samar da sukurori masu kariya daga stapler na endoscopic da aka yi a Amurka. Wannan aikin ya nuna yadda injiniyanci mai zurfi, ingantaccen tsari, da kimiyyar kayan dabaru ke haɗuwa don dawo da masana'antar na'urorin likitanci masu inganci zuwa ƙasar Amurka, yana tabbatar da aminci, aminci, da kuma inganci ga OEMs na na'urorin tiyata.

 

Muhimmin Sashe: Tsaro a cikin Ƙaramin Sukurori

Na'urorin tiyata na Endoscopic sune kayan aikin tiyata marasa amfani waɗanda ake amfani da su don yankewa da rufe nama a lokaci guda yayin tiyatar ciki, thoracic, da yara. Tsarin aminci na asali a cikin waɗannan na'urori galibi yana dogara ne akan ƙaramin sukurori na filastik wanda aka ƙera shi daidai. Wannan kayan aikin yana aiki azaman toshewa ko fasalin kullewa, yana hana harbi da haɗari da kuma tabbatar da cewa za a iya mayar da wukar zuwa wuri mai aminci a cikin gaggawa. Rashin nasararsa ba zaɓi bane.

 

"Ga na'urar likita ta Aji II kamar na'urar endoscopic stapler, kowace sashi, komai ƙanƙantarta, tana ɗauke da nauyin lafiyar majiyyaci," in ji wani babban injiniya a Ansix Tech. "Dole ne sukurorin aminci ya nuna daidaiton girma, ya jure wa tsaftacewa akai-akai, kuma ya yi aiki ba tare da wata matsala ba a kan madaidaicin kewayon ƙarfin juyi. Samun wannan na'urar a ƙasashen waje ya haifar da haɗarin lokacin jagora da bambancin inganci ga abokin cinikinmu. Manufarmu ita ce ƙirƙirar mafita ta sarkar samar da kayayyaki ta cikin gida wadda ta wuce dukkan ma'auni na aiki da ƙa'idoji."

 

Bukatar Kasuwa da Dokokin da suka wajaba

Manufar wannan aikin ta kasance da fannoni da dama. Bukatar tiyatar da ba ta da amfani sosai ta ƙara yawan na'urorin cire gashi da ake amfani da su sau ɗaya. A halin yanzu, na'urorin OEM na na'urorin likitanci suna fuskantar matsin lamba daga asibitoci da hukumomin da ke kula da lafiya don inganta bayyana gaskiya da juriya ga sarkar samar da kayayyaki. Dokar Tsarin Inganci ta FDA ta Amurka (21 CFR Sashe na 820) da MDR na EU suna buƙatar a binciki su sosai da kuma kula da tsarin aiki, ƙa'idodi waɗanda suka yi zurfi a cikin yanayin masana'antu na cikin gida mai takardar shaida.

 

Cancantar Ansix Tech a matsayin mai ƙera takardar shaidar ISO 13485:2016 ta samar da tushe mai mahimmanci. Wannan ƙa'idar tana kula da zagayowar rayuwar samarwa daga ƙarshe zuwa ƙarshe ga na'urorin likitanci, tana buƙatar ikon sarrafa komai daga samowar kayan masarufi zuwa marufi na ɗaki mai tsafta. Ga OEM na stapler, haɗin gwiwa da mai yin molding wanda ke riƙe da wannan takardar shaidar ba abu ne da za a iya tattaunawa a kai ba, wanda hakan ke kawar da haɗarin dukkan tsarin aiwatar da samfurin.

 

Daga Tsarin Zane Zuwa Rukunin Ɗaya: Tafiyar Ci Gaba

Mataki na 1: Tsarin Haɗin gwiwa da Kimiyyar Kayan Aiki

An fara aikin ne da nazarin Tsarin Masana'antu (DFM) mai zurfi. Injiniyoyin Ansix Tech sun yi aiki tare da ƙungiyar bincike da ci gaba na abokin ciniki don inganta yanayin sukurori don ƙera allura. Muhimman abubuwan da suka haɗa da daidaiton kauri na bango, wurin ƙofa, da dabarun fitar da iska don hana damuwa ko lalacewa.

 

Zaɓin kayan abu ya fi muhimmanci. Sukurori yana buƙatar ƙarfi mai yawa, juriya ga biocompatibility (ISO 10993), juriya ga gamma ko EtO sterilization, da kuma kyakkyawan juriya ga creep don kiyaye ƙarfin matsewa. Ansix Tech ta kimanta wasu polymers masu inganci na likitanci.

 

Duk da cewa takamaiman bayanai game da aikin mallakar kamfanoni ne, kayan aiki kamar Polyether Ether Ketone (PEEK) sun yi kama da na asali don irin waɗannan aikace-aikacen masu wahala. PEEK yana ba da "kwanciyar hankali mai girma da sauƙin sarrafawa yayin ƙera allura," wanda ke haifar da ingantaccen tsari mai inganci da araha. Maki kamar VESTAKEEP® iC4506 G, wanda aka sanya X-ray ba ya bayyana, misalai ne na kayan aiki na zamani da ake amfani da su a cikin kayan aikin likita. Don wannan aikin, an zaɓi wani takamaiman thermoplastic na injiniya mai bin FDA bayan gwaji mai tsauri.

 

Mataki na 2: Tabbatar da Kama-da-wane tare da Binciken Gudun Mold

Kafin a yanke wani ƙarfe, an yi cikakken nazarin kwararar Mold (MFA). Wannan kwaikwayon da aka yi bisa manhaja ya yi hasashen yadda robobin da aka narke za su cika ramin mold, yana gano lahani kamar tarkon iska, layukan walda, da alamun nutsewa a farkon matakin ƙira.

 

Ta amfani da kayan aiki kamar Autodesk Moldflow, ƙungiyar ta kwaikwayi cikawa, marufi, sanyaya, da warpage. Binciken ya inganta wurin da girman ƙofa, daidaiton gudu, da tsarin tashar sanyaya don tabbatar da cikawa iri ɗaya da ƙarancin damuwa ga sassa. Wannan matakin samfurin kama-da-wane yana da mahimmanci; kamar yadda masana masana'antu suka lura, MFA tana taimakawa wajen guje wa kurakurai masu tsada, wanda ke haifar da ingantattun sassa masu ƙarancin farashi da kuma saurin sauyawa.

 

Mataki na 3: Daidaito Tsarin Motsa Jiki & Zaɓin Karfe

Modulation ɗin kansa babban aikin injiniya ne mai inganci. Ganin yadda aikin yake da girma da daidaito, Ansix Tech ta zaɓi ƙarfe mai tauri, kamar wanda ya yi daidai da S136, don tsakiya da rami. Wannan dangin ƙarfe yana ba da "kyakkyawan juriyar tsatsa, da kuma iya gogewa mai kyau" kuma an ba da shawarar musamman ga molds na na'urorin likitanci. Taurinsa (yawanci HRC 45-52+) yana tabbatar da juriyar lalacewa mai kyau da kuma tsawon rayuwar kayan aiki ga miliyoyin zagayowar.

 

Tsarin mold ɗin ya haɗa da tsarin ramuka da yawa don samar da aiki. An zaɓi tsarin gudu mai zafi don rage ɓarnar abu da lokacin zagayowar. Duk da haka, tsarin sanyaya ya zama babban ƙalubalen injiniya. Kamar yadda Dr. David Crispino, Mataimakin Shugaban R&D a Atalys, ya bayyana, "Lokacin warkarwa shine mafi yawan lokacin zagayowar... kuma galibi ya ta'allaka ne ga ƙirar sanyaya ku". Roba suna da kyau sosai, wanda ke sa cire zafi cikin sauƙi ya zama da wahala.

 

Ƙungiyar ta tsara tsarin sanyaya mai tsari wanda ke bin tsarin siffar sukurori sosai fiye da yadda aka saba yi a da. Wannan hanyar, wadda aka samar ta hanyar dabarun kera kayayyaki na zamani, tana ba da damar sanyaya cikin sauri da daidaito, rage lokacin zagayowar kai tsaye da kuma inganta daidaiton sassan. An tsara fitar da iska a hankali ta amfani da fil masu jujjuyawar iska don guje wa yin alama ga mahimman saman sukurori.

 

Mataki na 4: Tabbatar da Tsarin Aiki (IQ/OQ/PQ) da Samar da Samfurin Gwaji

Bisa ga tsarin ISO 13485, an yi cikakken tsarin shigarwa, aiki, da cancantar aiki (IQ/OQ/PQ). Wannan ya haɗa da:

 

IQ: Tabbatar da cewa an shigar da mold, kayan aiki na taimako, da matsewa daidai.

 

OQ: Kafa tagogi masu ƙarfi na tsarin aiki (zafin narkewa, matsin lamba na riƙewa, lokacin sanyaya) don samar da sassan da suka dace.

 

PQ: Gudanar da wurare da yawa na samarwa a ƙarƙashin yanayi na yau da kullun don tabbatar da ƙarfin aiki da kwanciyar hankali na ƙididdiga (ta amfani da nazarin CpK/PpK).

 

An duba labaran farko ta hanyar na'urar aunawa (CMM) don tabbatar da duk mahimman ma'auni masu mahimmanci ga inganci. Abokin ciniki ya gudanar da gwaje-gwajen aiki akan haɗuwa ta amfani da sukurori masu sarrafa gwaji, wanda ya haifar da amincewa ta ƙarshe don samar da taro.

 

Kwarewa a Haɓaka Samarwa

Inganta Tsarin Aiki Don Inganci da Farashi

Da kammala tantancewa, an mayar da hankali kan ingancin aiki. Tsarin sanyaya da aka ƙera shi ne babban abin da ke haifar da inganci. Ta hanyar ƙara yawan kwararar zafi daga ɓangaren, ƙungiyar ta rage lokacin warkarwa, wanda shine mafi girman ɓangaren zagayowar. Ƙarin ingantawa ya haɗa da daidaita saurin allura, wuraren canzawa, da matsin lamba na marufi ta amfani da bayanai daga nazarin MFA da OQ. Wannan hanyar ƙera kayan kimiyya ta tabbatar da maimaitawa yayin da ake matse daƙiƙa marasa amfani daga kowane zagaye, wanda ke rage farashin kowane ɓangare kai tsaye.

 

Tabbatar da Inganci Ana Shigar da shi a Kowane Mataki

Kula da inganci ba dubawa ba ne a ƙarshe amma an gina shi a cikin tsarin. Ana gudanar da samarwa a cikin ɗakin tsafta na ISO Class 8 don hana gurɓatawa. Ana gano kowane yanki na kayan daga karɓa (tare da Takaddun Shaida na Bincike) ta hanyar bushewa, ƙera, da marufi. Kula da tsarin ƙididdiga na cikin tsari (SPC) yana sa ido kan ma'auni masu mahimmanci, kuma tsarin gani na atomatik yana duba lahani na gani. Duk wani rashin bin ƙa'ida yana haifar da tsarin Gyara da Rigakafi mai ƙarfi (CAPA), kamar yadda ISO 13485 ta buƙata.

 

Marufi da Isarwa Mai Sauri

Ana ƙirga sukurori da aka gama ta atomatik kuma a naɗe su a cikin kwantena masu tsabta, masu lakabi a cikin yanayin ɗakin tsaftacewa. An tattara dukkan Bayanan Tarihin Na'ura (DHR) - waɗanda ke haɗa wuraren kayan aiki, sigogin tsari, da bayanan dubawa - don cikakken gano su. Harabar masana'antu ta Ansix Tech da kuma hanyoyin jigilar kayayyaki masu sauƙi suna ba da damar yin sauri, daga oda zuwa jigilar kaya, suna ba OEM samfurin kaya mai inganci a kan lokaci.

 

Shawarar Darajar Ansix Tech: Bayan Ginawa

Wannan aikin ya nuna rawar da Ansix Tech ke takawa a matsayin abokin hulɗar masana'antu, ba wai kawai mai sayarwa ba. An yi amfani da "ƙwarewa mai yawa a cikin ƙira da haɓaka samfuran likitanci, ƙirar mold da ƙera... da zaɓin kayan aikin likitanci" gaba ɗaya. Ta hanyar amfani da ƙwarewar masana'antu da ƙwarewar ƙera allura, suna ba da "mafita masu ƙarancin haɗari ga haɓaka samfura, ingancin samfura mara aibi da ƙarancin farashin aiki".

 

Tanadin kuɗin da abokin ciniki ke kashewa yana da matakai da yawa: rage kuɗaɗen jigilar kaya da kuɗin fito daga masana'antar cikin gida, ƙarancin kuɗin da aka cire daga shara saboda ingantattun hanyoyin aiki, da kuma guje wa farashin da ka iya haifar da gazawar inganci ko sake dawowa saboda tsananin QMS. Bugu da ƙari, ingantaccen tsarin samar da kayayyaki yana rage haɗarin jinkirin aikin tiyata.

 

Kammalawa: Misali Don Nan Gaba

Nasarar da Ansix Tech ta yi wajen kera sukurori masu kariya daga ƙwayoyin cuta na endoscopic da aka yi a Amurka wani babban ci gaba ne. Yana nuna cewa tare da haɗin gwiwar da ya dace na fasaha, kayan aikin kwaikwayo na zamani, yin kayan aiki daidai, da kuma jajircewa mai ɗorewa ga tsarin inganci, Amurka za ta iya zama tushen gasa da kuma mafi kyawun kayan aikin likita. Yayin da asibitoci da likitocin tiyata ke ci gaba da dogaro da waɗannan kayan aikin ceton rai, ƙimar hanyar haɗin kai mai aminci, ta gida, da kuma ingantacciyar hanya, wadda kamfanoni kamar Ansix Tech suka ƙirƙira, ta ƙara bayyana.

 

 

 

Kamfanin Ansix Tech Ltd

Idan kuna da wasu tsare-tsare da suka shafi sukurori na kariya daga stapler da aka yi a Amurka, za ku iya tuntuɓar mu a kowane lokaci. Za mu mayar da ra'ayoyinku su zama gaskiya, mu bar ku ku cika burinku, kuma mu sami manyan oda daga kasuwa. Bayanan tuntuɓar mu sune info@ansixtech.com. Ko kuma ku tuntuɓi CTO ɗinmu, ta imel: stephen@ansixtech.com

 

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