Lapho a Uhlelo lwephampu yebele lusuka kumqondo luye ekukhiqizeni, ingxoxo yezohwebo ivamise ukuqala nge-form factor, izindlela zokumunca, kanye nentengo. Ingxoxo yokuthobelana iqala kwenye indawo: lokho okuthinta ubisi olumpontshiwe, yiziphi izingxenye ezithunyelwa ngaphakathi kwebhokisi, futhi yiziphi izincwadi ezingakhiqizwa umkhiqizi lapho umlawuli, indikimba eyazisiwe, noma ithimba lokuthobela izitolo lizicela.
Kubathengi belebula yangasese kanye nabathengi be-OEM, izinto zokumpompa amabele, izesekeli zephampu yebele, kanye nemibhalo yokuqinisekisa iphampu yebele akuyona imifudlana yokusebenza emithathu ehlukene. Ziyisistimu eyodwa, futhi igebe kunoma iyiphi yazo livame ukuvela sekwephuzile - njengokulibaziseka kokubhalisa, ukususwa kohlu lwemakethe, noma isimangalo sewaranti esibuyela emuva engxenyeni engabhalwanga muntu.
Ngepompo yebele kagesi, umbuzo wezinto ezisetshenziswayo awuhlobene kancane nombala wendlu noma ukuphela kwesibonisi. Igxila ezingxenyeni ezithinta izicubu zebele noma ubisi lwebele: isihlangu sebele noma i-flange, ikhithi yokuqoqa ubisi nebhodlela, ivalvu kanye nolwelwesi, noma yiliphi ishubhu, kanye nezimpawu nezixhumi ezingaphakathi kwendlela yokumunca.
Izinqumo ezimbili zokuklama zibeka ububanzi balowo msebenzi ngaphambi kokuba kucelwe noma yikuphi ukuhlolwa:
Vula isistimu ngokumelene nesistimu evaliwe. Kupompo yesistimu evaliwe, umgoqo ongokoqobo ugcina ubisi ngaphandle kweshubhu futhi ube kude ne-motor kanye ne-pneumatic path. Lokho kunciphisa indawo yokuxhumana nobisi ekhithi yokuqoqa futhi kunciphisa inani lezingxenye ezidinga ubufakazi bokuxhumana nobisi.
Ingasetshenziswa kabusha uma iqhathaniswa nezingxenye ezithinta ubisi ezisetshenziswa kanye. Izingxenye ezihloselwe imijikelezo ephindaphindwayo, njengama-flange namakhithi okuqoqwa, zidinga ukuhlanzwa nokuphinda kusetshenziswe ukuqinisekiswa izingxenye ezingasetshenziswa kanye kuphela.
Ithebula elingezansi libeka ukuthi umnikazi womkhiqizo ngokuvamile udinga ini ukuqinisekisa, ingxenye yendawo ngendawo.
Indawo yengxenye |
Indima ebalulekile |
Lokho umnikazi womkhiqizo okufanele akuqinisekise |
Isihlangu sesifuba / i-flange |
I-Silicone noma i-polymer eqinile ethinta izicubu zebele nobisi |
Ubufakazi be-Biocompatibility bokuxhumana kwesikhumba nobisi; usayizi omenyezelwe kanye nokubekezelelana; ukuthi osayizi abazikhethela bacaciswa kanjani kufayela lobuchwepheshe |
Ikhithi yokuqoqa, ibhodlela, ivalvu, ulwelwesi |
Izingxenye ze-polymer ezithinta ukudla kanye ne-elastomer endleleni yobisi |
Ukuthobelana nokuthintana nokudla emakethe yendawo; isimemezelo samahhala se-BPA; imiyalelo yokuhlanza kanye nokubulala amagciwane impahla iqinisekiswa ukuthi imelane |
Ama-tubing kanye ne-suction-path seals |
Amashubhu e-elastomer nezixhumi |
Ukuthi umklamo uyisistimu evaliwe (akukho ubisi ku-tubing); uma kuvuliwe, ubufakazi bokuxhumana nobisi kanye nezikhawu zokushintsha |
Izindlu zezimoto, izilawuli, amandla |
Ubunjiniyela bepulasitiki, isibonisi, ibhethri |
Ukuphepha kukagesi kanye nobufakazi be-EMC bokucushwa kukagesi; ilebula, ukumaka, kanye nezidingo zolimi |
Izinto zokupakisha nezinto eziphrintiwe |
Ikhathoni, okufakiwe, IFU |
Ukuqinisekisa ezokuthutha nempilo yeshelufu lapho kufanele khona; Ukufakwa kolimi lwe-IFU kumakethe ngayinye yendawo |
Imodi eyodwa yokuhluleka ephindelelayo ifanele ukuqanjwa. Umnikazi womkhiqizo ugunyaza isampula ekucushweni okukodwa; ukukhiqizwa bese kungena esikhundleni se-elastomer yomthombo wesibili wevalvu, noma ibanga elihlukile le-silicone le-flange. Obambele angenza ngokulinganayo, kodwa isethi yamadokhumenti manje ayinembile. Ukushintsha ukulawulwa kwezinto ezithinta ubisi ngakho-ke kufanele kuvunyelwane ngokubhala ngaphambi kokukhiqizwa ngobuningi, hhayi ukuxoxisana ngemva kokuba inqwaba emanzini.
Izesekeli Zepompo Lesifuba - Lapho Izinhlelo Zokuthobelana Zivamise Ukushibilika
Izinsiza zithwala ingozi yokuthobela engalingani ngoba ziphindaphinda isibalo se-SKU futhi zishintsha kaningi kunepompo ngokwayo. Iyunithi yesisekelo esisodwa ingakhiqiza izilungiselelo ezidayiswayo eziyishumi nambili uma osayizi be-flange, amabhodlela, nezinketho zokuphatha zibaliwe.
Ukulinganisa kwesihlangu sesifuba. Isivikelo sesifuba esingu-24 mm sijwayelekile, esinosayizi ongakhethwa kukho abatholakala endaweni efanayo. Usayizi ngamunye uyingxenye ehlukile enomdwebo wayo kanye namathuluzi, futhi ngamunye kufanele uboniswe ekucacisweni okugunyaziwe kunokuba uthathwe njengokuhlukile kweyunithi yesisekelo.
Amabhodlela nezingxenye ezihlobene nokudla. Uma uhlelo luthumela amabhodlela noma iziqukathi zokugcina ubisi, izidingo zokusetshenziswa kwezingane nokudla ezifana ne-EN 14350 zingasebenza ngokuhambisana nezidingo zedivayisi, kuye ngendawo nemakethe.
Ama-valve, ama-membrane, namashubhu. Lezi zingxenye ezisebenzisekayo ziqhuba ukuthenga okuphindayo kanye nomsebenzi wangemva kokuthengisa. Izingxenye zereferensi ezigunyaziwe kufanele zikhiywe, futhi ushintsho kulokho okusebenzisekayo kufanele kuthathwe njengomcimbi wamadokhumenti, hhayi imininingwane yokukhiqiza.
Ingxenye eyisipele necebo lesevisi. Abanikazi bomkhiqizo kufanele bachaze ukuthi iziphi izesekeli ezinikezwa njengezipele, iwindi lokutholakala elihlosiwe, kanye nokuthi abasabalalisi bahlela kabusha yini ngokucacisa okufanayo okulawulwayo.
Izinto zokwenza ngokwezifiso. Ilogo, umbala, nosayizi wesihlangu sesifuba yizona ezivame kakhulu ezinhlelweni zochungechunge lwe-LD. Ngayinye iwukucushwa, futhi ngayinye kufanele ivele esimisweni esigunyaziwe ukuze iyunithi ethunyelwe, okuqukethwe kuhlu, nefayela lobuchwepheshe kuchaze umkhiqizo ofanayo.
Imibhalo Yokuqinisekisa Iphampu Yebele - Uhlu Lokuhlola Lokucela
Indlela ecace kakhulu yokuphatha le ndawo wuhlu lokuhlola olubhaliwe oluthunyelwa kumkhiqizi ngaphambi kokuthi uhlelo lunikezwe. Isethi ngqo incike ekusetshenzisweni okuhlosiwe, ukuhlukaniswa, kanye nemakethe yendawo, futhi umkhiqizi kufanele azimisele ukusho ngokucacile lapho isigaba singasebenzi kunokudlulisela isitifiketi esijwayelekile endaweni yaso.
Isigaba samadokhumenti |
Lokho elikuhlanganisayo ngokuvamile |
Kungani umnikazi womkhiqizo eyidinga |
Uhlelo lwekhwalithi |
Isitifiketi se-ISO 13485 esinobubanzi obushiwo; I-MDSAP lapho kufanele khona |
Isekela wonke amanye amadokhumenti futhi icelwa ngokujwayelekile ekucwaningweni kwemizimba yomthengisi nokwaziswayo |
I-Biocompatibility |
Ukuhlolwa kwezinto ezithinta isikhumba kanye nobisi ngokumelene nochungechunge lwe-ISO 10993, okuhlanganisa ukuhlukaniswa kwamakhemikhali lapho kusetshenziswa khona. |
Isekela isimemezelo sezinto zokusebenza emibhalweni yezobuchwepheshe |
Ukuhambisana nokudla nokuhambisana nezinto ezibonakalayo |
Izidingo zokudla-zothintana nemakethe yendawo kuma-polymers wendlela yobisi; isimemezelo samahhala se-BPA; RoHS kanye ne-REACH lapho kufanele khona |
Ihlanganisa izingxenye ezibamba noma ezidlulisa ubisi, kanye nezingxenye ze-electronic kanye ne-polymer ngaphansi kwemikhawulo yento |
Ukulawulwa kobungozi |
Isifinyezo sefayela le-ISO 14971 lokulawulwa kwezinhlekelele lemodeli |
Isici esidingekayo semibhalo yezobuchwepheshe; isekela ukusebenziseka kanye nezinqumo ze-IFU |
Ukuphepha kukagesi kanye ne-EMC |
Imibiko yokuhlola yokucushwa kukagesi ngokumelene ne-IEC 60601-1 kanye ne-IEC 60601-1-2 |
Ubufakazi obubalulekile bokubhaliswa kwephampu yebele enamandla |
Ukuqinisekiswa kokusebenza |
Ukuqinisekiswa kwedizayini kwamaleveli okumunca, izindlela, nemikhawulo ye-vacuum ngokumelene nokucaciswa okuchaziwe |
Isekela izimangalo zokusebenza futhi ihlukanise ukwahluka kwemikhiqizo yokuma kwesiteshi |
Ukuhlanza, ukukhipha amagciwane, nokusebenzisa kabusha |
Ukuqinisekiswa kwenqubo yokuhlanza echazwe ku-IFU, kanye nedatha yomjikelezo wokusetshenziswa kabusha kwezingxenye zokuthintana nobisi ezingasetshenziswa kabusha |
Igcina imiyalelo eshicilelwe ihambisana nokusebenza kwempahla ehloliwe |
Ukupakisha, ezokuthutha, kanye nokulebula |
Ukuqinisekisa ezokuthutha nokupakishwa lapho kufanele khona; ilebula, i-IFU, nedatha ye-UDI |
Yehlisa izimangalo zokonakala kwezokuthutha futhi isekela ukugunyazwa kwemakethe |
Ukufinyelela okulawulwayo kanye nezimakethe |
Isimemezelo sokuvumelana, izitifiketi ezisebenzayo zemodeli ngayinye njenge-CE MDR, kanye nesimo esingu-510(k) lapho kufanele khona. |
Iqinisekisa ukuthi yikuphi ukumaketha ukucushwa okungase kungene ngempela |
Imikhuba emibili yenza lolu hlu lokuhlola lusebenze. Okokuqala, cela amadokhumenti ngemodeli ngayinye kanye nokucushwa ngakunye, ngoba isitifiketi sezinga lenkampani asisho lutho mayelana neyunithi e-odwayo. Okwesibili, cela ukuthi uhlu lwedokhumenti lubuyekezwe futhi noma nini lapho izinto ezithinta ubisi, into esetshenziswayo, noma ukumiswa kwamandla kushintsha - lelo yiphuzu lapho uhlelo oluthobelayo luba ngokungathobeli.
I-Joytech Isekela Kanjani Izinhlelo Zokuthobela Umnikazi Womkhiqizo
I-Joytech Healthcare ikhiqiza amaphampu webele ngaphakathi kochungechunge lwe-LD, ububanzi obuhlanganisa ugesi ojwayelekile, ugesi ophindwe kabili, ophinde ushajwe, kanye nokulungiswa kwezandla.
Idizayini yokuxhumana nobisi. Amamodeli ochungechunge lwe-LD aklelisa izinto ezingenazo i-BPA, isihlangu sesifuba esingu-24 mm njengesijwayelekile esinosayizi ongakhethwa kukho, nasemamodelini afana I-LD-209 isistimu evaliwe, isakhiwo esilwa nokugeleza emuva esinezingxenye ezikhiphekayo, okulula ukuzihlanza.
Izinkundla ezilungisekayo. Amamodi okumpompa amaleveli ayisishiyagalolunye kuwo wonke amaleveli okumunca ayisishiyagalolunye, isibonisi se-LED, isibani sasebusuku ozikhethela sona, kanye nebhethri ye-lithium eshajekayo, u-Type-C, noma amandla e-AA avumela umkhiqizo uchaze okungenayo, okujwayelekile, nokuthuthukisiwe okusuka kungxenyekazi eyodwa.
Ikhwalithi nesitifiketi. Ukukhiqiza kuhlala ngaphansi kwe-ISO 13485, MDSAP, nezinhlelo zekhwalithi eqinisekisiwe ze-BSCI, ezine-CE MDR kanye ne-FDA etholakala kumamodeli akhethiwe. Ukufakwa kwesitifiketi kuqinisekiswa ngemodeli ngayinye kanye nemakethe yendawo ngayinye kunokuba kusetshenziswe kulo lonke uhla.
Ukwenza ngokwezifiso. Ilogo, umbala, nosayizi wesihlangu sesifuba kusekelwa ngaphakathi kwezinhlelo ze-OEM ne-ODM.
Amandla nobunjiniyela. 3 izikhungo zokukhiqiza, 260,000 m² yezindawo ezizenzakalelayo, imigqa yokukhiqiza engu-30+, izinto ezintsha ezinelungelo lobunikazi eziyi-100+, kanye nethimba le-R&D lephampu yebele elizinikele kanye nokukhiqizwa kwesikali sohlelo lokusekela umugqa wokukhiqiza.
Uzakwethu
Uhlelo lwephampu yebele luvikeleka kuphela njengamadokhumende angemva kwezinto zalo kanye nezinsiza. I-Joytech isebenza nabasabalalisi, abanikazi bomkhiqizo, kanye nabathengi be-OEM/ODM ukuze baqondanise ukukhethwa kwempahla yokuxhumana nobisi, ukucushwa kwezinsiza, kanye namadokhumenti okuqinisekisa nezimakethe uhlelo olwakhelwe zona.
Ukuze uxoxe ngohlelo lokumpompa amabele, cela uhlu lokuhlola lwemibhalo, noma hlela amasampula okuhlola, thintana naye sale14@sejoy.com.
FAQ
Q1: Yiziphi izinto zokumpompa amabele ezidinga imibhalo eminingi?
Izingxenye ezithinta izicubu zebele noma ubisi lwebele zithwala imfuneko enzima kakhulu: izihlangu zamabele, izinto zokuqoqa, amabhodlela, amavalvu, ulwelwesi, nanoma yimaphi amashubhu noma ama-seal endleleni yokumunca. Izindlu kanye nezinto zokubonisa ngokuvamile zimbozwa ukuphepha kukagesi, i-EMC, nobufakazi bokukhawulelwa kwezidakamizwa esikhundleni salokho.
Q2: Ingabe izesekeli zephampu yebele zimbozwe imibhalo efanayo nepompo?
Hhayi ngokuzenzakalelayo, futhi lokhu igebe evamile. Izinsiza ezinjengabanye osayizi be-flange, amabhodlela, namavalvu ashintshayo zingase zethule ezazo izidingo zokudla, ukusetshenziswa kwengane, noma izinto ezibonakalayo ngaphezu kwamadokhumenti edivayisi yephampu. Ukucushwa kwesesekeli ngakunye kufanele kuqinisekiswe ngokumelene nemakethe yendawo.
Q3: Uyini umehluko phakathi kwesitifiketi senkampani kanye nemibhalo yokuqinisekisa yemodeli ethile?
Isitifiketi senkampani, njengesitifiketi sobubanzi be-ISO 13485, sichaza isistimu yekhwalithi. Amadokhumenti okuqinisekisa amamodeli athile achaza iyunithi ngqo e-odwayo - izinto zayo, izesekeli zayo, ukumiswa kwayo kukagesi, nokusebenza kwayo okuqinisekisiwe. Abathengisi nabalawuli ngokuvamile balindele kokubili, futhi okwesibili yileso esisekela ukubhaliswa okuthile.
