Udupira tw'umutekano twakozwe muri Amerika two gufunga imashini ikoresha endoscopic

Udupira tw'umutekano twakozwe muri Amerika two gufunga imashini ikoresha endoscopic

 

Ansix Ikoranabuhanga ritanga serivisi zo mu rugo zo gutanga ibikoresho by'ubuvuzi hakoreshejwe vis zikozwe neza ku bikoresho byo gushyiramo ibikoresho byo mu bwoko bwa endoscopic.

Muri iki gihe aho ubushobozi bwo guhangana n’ibicuruzwa n’inganda zo mu gihugu ari ingenzi cyane ku bikoresho by’ingenzi by’ubuvuzi, icyuma cyihariye cyo gushushanya inshinge kirimo gukora ibintu byinshi. Ansix Tech, uruganda rwemewe na ISO 13485:2016, rwateje imbere kandi rutangira gukora ku rwego rwuzuye ibikoresho by’umutekano byakozwe muri Amerika bya endoscopic stapler. Uyu mushinga ugaragaza uburyo ubuhanga buhanitse, kugenzura neza inzira, n’ubumenyi bw’ibikoresho birimo guhuzwa kugira ngo bigarure ibikoresho by’ubuvuzi bigezweho ku butaka bwa Amerika, bigamije kwemeza ko ibikoresho by’ubuvuzi byemewe, birangwa n’umutekano, kandi bikaba byiza ku bikoresho byo kubaga.

 

Igice cy'ingenzi: Umutekano mu kantu gato

Ibikoresho byo kubaga bya endoscopic ni ibikoresho byo kubaga bidakoresha uburyo bwinshi bikoreshwa mu gukata no gufunga ingingo icyarimwe mu gihe cyo kubaga mu nda, mu gituza no mu bana. Uburyo bw'ingenzi bw'umutekano muri ibi bikoresho akenshi bushingiye ku ruziga ruto rwa pulasitiki rwakozwe neza. Iki gice gikora nk'igikoresho cyo kwirinda cyangwa gufunga, kikarinda kurasa ku bw'impanuka no kwemeza ko icyuma gishobora kugaruka mu mwanya wacyo mu gihe cy'impanuka. Kunanirwa kwacyo si amahitamo.

 

Injeniyeri mukuru muri Ansix Tech asobanura ati: "Ku gikoresho cyo kwa muganga cyo mu cyiciro cya kabiri nk'icyuma gifata ibikoresho byo mu bwoko bwa endoscopic, buri gice, nubwo cyaba gito gute, gifite uburemere bw'umutekano w'umurwayi." "Urushundura rw'umutekano rugomba kugaragaza ubuziranenge budasanzwe, kwihanganira gucibwa burundu inshuro nyinshi, no gukora neza mu rugero ruhamye rw'imbaraga. Gushaka iki gikoresho cyo mu mazi byazanye ingaruka zo guhindagurika kw'igihe cyo gukoresha ndetse n'ubwiza bw'umukiriya wacu. Intego yacu yari ugushyiraho igisubizo cy'uruhererekane rw'ibikoresho byo mu gihugu kirenze ibipimo byose by'imikorere n'amategeko."

 

Ibisabwa ku isoko n'amabwiriza agenga

Intego y’uyu mushinga yari myinshi. Gusaba cyane kubagwa mu buryo budakoresha imiti myinshi byatumye umubare w’ibikoresho byo gusana imiti bikoreshwa rimwe gusa wiyongera. Muri icyo gihe, ibigo bitanga ibikoresho by’ubuvuzi bihura n’igitutu gikomeye gituruka ku bitaro n’inzego zishinzwe kugenzura imikoreshereze y’ibikoresho kugira ngo binoze ubwisanzure n’ubushobozi bwo guhangana n’ihindagurika ry’imikoreshereze y’ibikoresho. Itegeko rigenga ubwiza bw’ibicuruzwa bya FDA muri Amerika (21 CFR Igice cya 820) na MDR ya EU bisaba ko habaho gukurikirana no kugenzura ibikorwa byabyo mu buryo buhamye, amahame bikubiye mu buryo bwimbitse mu nganda zikora mu gihugu zemewe.

 

Impamyabushobozi ya Ansix Tech nk'uruganda rwemewe na ISO 13485:2016 niyo yashinze ishingiro. Iri hame rigenga imikorere y'ibikoresho by'ubuvuzi kuva ku ntangiriro kugeza ku mpera, risaba kugenzura ibintu byose kuva ku gushakisha ibikoresho fatizo kugeza ku gupakira mu cyumba cyo gusukura. Ku bashinzwe gukusanya ibikoresho, gukorana n'uruganda rufite iki cyemezo byari ngombwa cyane, bigabanya ibyago byose byo gushyira mu bikorwa ibicuruzwa.

 

Kuva ku Gishushanyo mbonera kugeza ku Itsinda rya Mbere: Urugendo rw'Iterambere

Icyiciro cya 1: Gushushanya hamwe n'ubumenyi bw'ibikoresho

Umushinga watangiye n'isesengura rya Deep-Dize Design for Manufacturability (DFM). Injeniyeri za Ansix Tech zakoranye n'itsinda ry'abakiriya rishinzwe ubushakashatsi n'iterambere kugira ngo barusheho kunoza imiterere y'urushundura kugira ngo bashyireho inshinge. Ibintu by'ingenzi birimo ubugari bw'urukuta, aho irembo riherereye, n'ingamba zo gusohora kugira ngo hirindwe stress cyangwa guhindagurika kw'imashini.

 

Guhitamo ibikoresho byari ingenzi cyane. Isoko ry'icyuma risaba imbaraga nyinshi, ubushobozi bwo guhuza ibintu (ISO 10993), kudakoresha gamma cyangwa EtO mu buryo bworoshye, no kudakoresha neza imbaraga zo gufunga kugira ngo imbaraga zo gufunga zikomeze gukomera. Ansix Tech yasuzumye polymer nyinshi zo mu rwego rwo hejuru mu buvuzi.

 

Nubwo amakuru arambuye ku mushinga ari umwihariko, ibikoresho nka Polyether Ether Ketone (PEEK) ni ingenzi cyane kuri bene ibyo bikorwa bigoye. PEEK itanga "ubudahangarwa bwo hejuru no koroshya gutunganya mu gihe cyo gutera inshinge," bigatuma habaho uburyo bwo gukora bunoze kandi buhendutse. Amanota nka VESTAKEEP® iC4506 G, ihinduka X-ray opaque, ni ingero z'ibikoresho bigezweho bikoreshwa mu bikoresho by'ubuvuzi. Kuri uyu mushinga, hatoranijwe thermoplastic yihariye, ikurikiza FDA nyuma yo gupimwa cyane.

 

Icyiciro cya 2: Kwemeza ikoranabuhanga hakoreshejwe uburyo bwa "Mold Flow Analysis"

Mbere y'uko icyuma icyo ari cyo cyose gicibwa, igishushanyo cyakozwe mu buryo bwimbitse mu isesengura ry'umuyoboro w'amazi (MFA). Ubu buryo bwo kwigana bushingiye kuri porogaramu bugaragaza uburyo pulasitiki ishongeshejwe izuzura umwobo w'umuyoboro, bukagaragaza inenge zishobora kubaho nko gucukura umwuka, imiyoboro yo gusudira, n'ibimenyetso byo gusimbuka mu ntangiriro z'icyiciro cyo gushushanya.

 

Ikoresheje ibikoresho nka Autodesk Moldflow, itsinda ryakoresheje ikoranabuhanga ryo kuzuza, gupakira, gukonjesha, no gufunga. Isesengura ryanogeje aho irembo riherereye n'ingano yaryo, uburinganire bw'umukingo, n'imiterere y'umuyoboro wo gukonjesha kugira ngo habeho kuzuza kimwe no kugabanya umuvuduko w'ibice. Iki cyiciro cyo gushushanya ni ingenzi cyane; nk'uko impuguke mu nganda zibivuga, MFA ifasha kwirinda amakosa ahenze, bigatuma ibice byiza birushaho kuba byiza kandi bigatanga ibiciro bike kandi bikarushaho kugerwaho vuba.

 

Icyiciro cya 3: Uburyo bwo gukora neza Igishushanyo mbonera cy'ibihumyo & Guhitamo ibyuma

Iyi folde ubwayo ni umuhanga mu by’ubuhanga bwo gukora neza. Bitewe n’uko umushinga wayo ari mwinshi kandi utunganye, Ansix Tech yahisemo icyuma gikomeye cya stainless steel, nk’urwego rungana na S136, kugira ngo gikoreshwe mu gice cyo hagati n’icyumba. Uyu muryango w’ibyuma utanga "ubudahangarwa bwiza bwo kwangirika, ubukonje bwiza" kandi birasabwa cyane ku bikoresho by’ubuvuzi. Ubukana bwayo (ubusanzwe HRC 45-52+) butuma idasaza neza kandi ikamara igihe kirekire mu gihe cy’amasaha menshi.

 

Igishushanyo mbonera cy’ibibumbano cyari gifite imiterere myinshi yo gukora umusaruro. Sisitemu ishyushye yatoranyijwe kugira ngo igabanye imyanda y’ibikoresho n’igihe cyo gukonjesha. Icyakora, sisitemu yo gukonjesha yari ikibazo gikomeye mu buhanga. Nk’uko Dr. David Crispino, Visi Perezida w’Ishami rishinzwe ubushakashatsi n’iterambere muri Atalys abisobanura, "Igihe cyo gukonjesha ni cyo gihe kinini cy’igihe cyose cyo gukonjesha ... kandi ahanini biterwa n’igishushanyo mbonera cyawe cyo gukonjesha". Plastike ni ibyuma bikingira ubushyuhe neza, bigatuma gukuraho ubushyuhe bigorana.

 

Itsinda ryakoze sisitemu yo gukonjesha ijyanye n’imiterere y’imigozi isanzwe kurusha uko imyitozo gakondo igororotse yabikora. Ubu buryo, bukoreshejwe ubuhanga buhanitse bwo gukora, butuma habaho gukonjesha kwihuta kandi kumwe, kugabanya igihe cyo gukora no kunoza imiterere y’ibice. Gusohora byateguwe neza hakoreshejwe udupira two gusohora uduce duto kugira ngo hirindwe ko habaho ikimenyetso cy’imikorere y’ingenzi y’imigozi.

 

Icyiciro cya 4: Kwemeza inzira (IQ/OQ/PQ) n'umusaruro w'icyitegererezo

Hakurikijwe ISO 13485, inzira yo gushushanya inshinge yakozwe mu buryo bwuzuye, mu gushyiraho, no mu mikorere (IQ/OQ/PQ). Ibi byasabaga:

 

IQ: Kugenzura ko ibumba, ibikoresho by'inyongera, n'imashini byashyizweho neza.

 

OQ: Gushyiraho amadirishya akomeye yo gupima imikorere (ubushyuhe bwo gushonga, umuvuduko wo gufata, igihe cyo gukonjesha) kugira ngo hakorwe ibice bihuye.

 

PQ: Gukora ahantu henshi hakorerwa umusaruro mu buryo busanzwe kugira ngo hagaragazwe neza ubushobozi bw'imikorere n'uko ibintu bihagaze (hakoreshejwe isesengura rya CpK/PpK).

 

Ibintu bya mbere byagenzuwe hakoreshejwe imashini ipima ibintu (CMM) kugira ngo harebwe ingano zose z’ingenzi zijyanye n’ubuziranenge. Umukiriya yakoze isuzuma ry’imikorere ku bikoresho akoresheje vis za pilot-run, bituma byemezwa burundu ko byakozwe mu buryo bwinshi.

 

Gusobanukirwa neza uburyo umusaruro uzamuka

Gutunganya Uruhererekane rw'Ibikorwa kugira ngo Bikore neza kandi Bigire Ikiguzi

Igenzura rirangiye, intego yashyizwe ku kuba imikorere myiza. Sisitemu yo gukonjesha yakozwe mu buryo bwa tekiniki yari ingenzi mu gutuma habaho imikorere myiza. Mu kongera ubushyuhe buva mu gice, itsinda ryagabanyije igihe cyo kuvura, ari na cyo gice kinini cy'uruziga. Ivugurura ryinshi ryasabaga kunonosora umuvuduko wo gutera, aho guhinduranya ibintu, n'umuvuduko wo gupakira hakoreshejwe amakuru yavuye mu bushakashatsi bwa MFA na OQ. Ubu buryo bwa siyansi bwo gushushanya bwatumye habaho gusubiramo mu gihe cyo gukuramo amasegonda atari ngombwa kuri buri ruziga, bigabanura neza ikiguzi cya buri gice.

 

Igenzura ry'Ubuziranenge rishyirwa muri buri ntambwe

Igenzura ry’ubuziranenge si igenzura rirangira ahubwo ryubatswe mu buryo bukoreshwa. Umusaruro ukorerwa mu cyumba cy’isuku cya ISO Class 8 kugira ngo hirindwe ubwandu. Buri gice cy’ibikoresho gikurikiranwa uhereye ku byakiriwe (hamwe n’icyemezo cy’isesengura) binyuze mu kumisha, gushushanya, no gupakira. Igenzura ry’imikorere y’ibarurishamibare mu bikorwa (SPC) rikurikirana ibipimo by’ingenzi, kandi sisitemu zo kureba zikora zigenzura ko nta busembwa bwo kureba. Kutubahiriza amabwiriza yose bitera sisitemu ikomeye yo gukosora no gukumira (CAPA), nk’uko bisabwa na ISO 13485.

 

Gupakira no Gutanga byihuse

Ibyuma byarangiye bibarwa mu buryo bwikora kandi bigashyirwa mu bikoresho bisukuye kandi bifite ikirango mu cyumba cyo gusukura. Inyandiko yose y'amateka y'ibikoresho (DHR) - ihuza ibikoresho, ibipimo by'imikorere, n'amakuru y'igenzura - irakusanywa kugira ngo ikurikiranwe neza. Ikigo cy'inganda cya Ansix Tech gihuriweho hamwe n'ibikoresho byoroshye bituma habaho impinduka zihuse, kuva ku gutumiza kugeza ku koherezwa, biha OEM icyitegererezo cyizewe cyo kubika ibintu mu gihe gikwiye.

 

Agaciro ka Ansix Tech: Uretse Gutunganya

Uyu mushinga ugaragaza uruhare rwa Ansix Tech nk'umufatanyabikorwa mu nganda, atari umucuruzi gusa. "Ubunararibonye bwabo bwinshi mu gushushanya no guteza imbere ibikoresho by'ubuvuzi, gushushanya no gukora ibumba ... no guhitamo ibikoresho by'ubuvuzi" bwakoreshejwe byuzuye. Bakoresheje ubunararibonye mu nganda n'ubuhanga mu gushushanya, batanga "ibisubizo byo guteza imbere ibicuruzwa bifite ingaruka nke, ireme ry'ibicuruzwa ritagira inenge n'ikiguzi gito cy'umushinga".

 

Ikiguzi cy’umukiriya cyo kuzigama kiri mu byiciro byinshi: kugabanuka kw’amafaranga akoreshwa mu gutwara ibintu n’imisoro aturuka mu nganda zo mu gihugu, kugabanuka kw’ibiciro by’ibisigazwa bitewe n’imikorere myiza, ndetse no kwirinda ikiguzi cy’ibura ry’ubuziranenge cyangwa gusubizwa inyuma bitewe na QMS ikomeye. Byongeye kandi, uruhererekane rw’ibikoresho rwizewe rugabanya ibyago byo gutinda kubagwa.

 

Umwanzuro: Icyitegererezo cy'ejo hazaza

Ikorwa rya Ansix Tech ryakozwe muri Amerika mu buryo bwa "endoscopic stapler security screws" ni ikintu gito cyane. Bigaragaza ko hamwe n’ubuhanga bukwiye mu bya tekiniki, ibikoresho bigezweho byo kwigana, gukora ibikoresho neza, no kwiyemeza kudahwema gukoresha sisitemu nziza, Amerika ishobora kuba isoko ry’ipiganwa kandi ryiza ku bice by’ingenzi by’ubuvuzi. Uko ibitaro n’abaganga b’inzobere mu kubaga bakomeje kwishingikiriza kuri ibi bikoresho bikiza ubuzima, agaciro k’umuyoboro w’ibikoresho birinzwe, byo mu rugo, kandi bikoresha ubwiza, byakozwe n’ibigo nka Ansix Tech, karushaho kugaragara neza.

 

 

 

Ansix Tech Co Ltd

Niba ufite gahunda zijyanye n'icyuma gikingira umutekano cyakozwe muri Amerika (endoscopic stapler safety screw), ushobora kutwandikira igihe icyo ari cyo cyose. Tuzahindura ibitekerezo byawe mu impamo, tuguhe intego zawe, kandi tuguhe amadeni menshi ku isoko. Amakuru yacu yo kuduhamagara ni info@ansixtech.com. Cyangwa uhamagare umuyobozi mukuru w'ikigo cyacu, ohereza ubutumwa kuri: stephen@ansixtech.com

 

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