Iyo a porogaramu yamabere yimuka iva mubitekerezo yerekeza kumusaruro, ikiganiro cyubucuruzi mubisanzwe gitangirana nibintu bifatika, uburyo bwo guswera, nigiciro. Ikiganiro cyo kubahiriza gitangirira ahandi: ibyo amata yavomye akora mubyukuri, ibice byohereza mumasanduku, hamwe ninyandiko uwabikoze ashobora gukora mugihe umugenzuzi, umubiri wabimenyeshejwe, cyangwa itsinda ryubahiriza ibicuruzwa bibasabye.
Kubaguzi-label hamwe nabaguzi ba OEM, ibikoresho bya pompe yamabere, ibikoresho bya pompe yamabere, hamwe nimpapuro zemeza pompe ntabwo aribikorwa bitatu bitandukanye. Ni sisitemu imwe, kandi icyuho muri kimwe muri byo gikunda kugaragara bitinze - nko gutinda kwiyandikisha, kuvanaho isoko ku isoko, cyangwa garanti isaba kuva mu gice nta muntu wanditse.
Kuri pompe yamashanyarazi, ikibazo cyibikoresho ntaho gihuriye nibara ryamazu cyangwa kwerekana kurangiza. Yibanze ku bice bihuza ibice byamabere cyangwa amata yonsa: ingabo yamabere cyangwa flange, ibikoresho byo gukusanya amata hamwe nicupa, valve na membrane, igituba icyo aricyo cyose, hamwe na kashe hamwe nuhuza imbere yinzira yo guswera.
Ibyemezo bibiri byo gushushanya bishyiraho urwego rwakazi mbere yuko ikizamini gisabwa:
Fungura sisitemu na sisitemu ifunze. Muri pompe ifunze-sisitemu, inzitizi yumubiri ituma amata atagaragara kandi kure ya moteri na pneumatike. Ibyo bigabanya amata ahuza ibikoresho byo gukusanya kandi bikagabanya umubare wibice bikenera ibimenyetso byerekana amata.
Kongera gukoreshwa hamwe no gukoresha amata-ibice bimwe. Ibice bigenewe gusubiramo inshuro nyinshi, nka flanges hamwe nibikoresho byo gukusanya, bikenera gusukura no kongera kwemeza ko ibice bimwe bikoreshwa bidakorwa.
Imbonerahamwe ikurikira irerekana icyo nyir'ikirango akeneye kwemeza, agace k'ibice akarere.
Agace k'ibigize
Uruhare rwibintu bisanzwe
Icyo nyir'ikimenyetso agomba kwemeza
Inkinzo y'ibere / flange
Silicone cyangwa polymer ikaze ihuza amabere n'amata
Ibimenyetso bifatika bihuza uruhu n'amata; byatangajwe ingano n'ubworoherane; uko ingano yubushake igaragara muri dosiye yubuhanga
Ibikoresho byo gukusanya, icupa, valve, membrane
Ibiryo-bihuza polymer nibice bya elastomer munzira y'amata
Guhuza ibiryo-guhuza isoko ryerekeza; Imenyekanisha rya BPA; gusukura no kwanduza amabwiriza ibikoresho byemewe kugirango bihangane
Kuringaniza no guswera-inzira kashe
Elastomer tubing hamwe nabahuza
Niba igishushanyo gifunze sisitemu (nta mata muri tubing); niba ifunguye, ibimenyetso-byerekana ibimenyetso hamwe nigihe cyo gusimbuza
Amazu ya moteri, kugenzura, imbaraga
Ubwubatsi bwa plastiki, kwerekana, bateri
Umutekano w'amashanyarazi n'ibimenyetso bya EMC kuboneza amashanyarazi; ikirango, ikimenyetso, nibisabwa ururimi
Gupakira n'ibikoresho byacapwe
Ikarito, shyiramo, IFU
Gutwara no gutunga ubuzima bwemewe aho bishoboka; IFU ikwirakwiza ururimi kuri buri soko ryerekeza
Uburyo bumwe bwo kunanirwa burigihe bukwiye kwitwa izina. Nyiri ikirango yemeje icyitegererezo muburyo bumwe; umusaruro noneho usimbuze isoko-ya kabiri ya elastomer kuri valve, cyangwa urwego rutandukanye rwa silicone kuri flange. Umusimbuye arashobora gukora kimwe, ariko inyandiko zashyizweho ubu ntabwo arukuri. Guhindura igenzura kubikoresho byamata-bigomba rero kumvikana mu nyandiko mbere y’umusaruro rusange, bitumvikanyweho nyuma yicyiciro kiri kumazi.
Ibikoresho byo kuvoma amabere - Aho gahunda yo kubahiriza isanzwe inyerera Ibikoresho bitwara ibyago byo kubahiriza bidakwiye kuko bigwiza kubara SKU kandi bigahinduka kenshi kuruta pompe ubwayo. Igice kimwe cyibanze gishobora kubyara ibicuruzwa icumi bigurishwa iyo ingano ya flange, amacupa, hamwe nuburyo bwo gutwara ibarwa.
Ingano yingabo. Ingabo ya 24 mm yamabere nigipimo gisanzwe, hamwe nubunini butaboneka kuboneka kumurongo umwe. Ingano yose nigice gitandukanye nigishushanyo cyayo nigikoresho cyacyo, kandi buri kimwe kigomba kugaragarira mubisobanuro byemewe aho gufatwa nkibintu bitandukanye byibanze.
Amacupa nibice bijyanye no kugaburira. Niba porogaramu yohereje amacupa cyangwa ibikoresho byo kubika amata, imikoreshereze yumwana nibisabwa-guhuza ibiryo nka EN 14350 birashobora gukoreshwa hamwe nibisabwa nibikoresho, bitewe nigice nisoko.
Indangagaciro, membrane, hamwe na tubing. Ibi bice bikoreshwa birashobora gutwara kugura no nyuma yo kugurisha. Ibice byemewe bigomba gufungwa, kandi impinduka kumikoreshereze igomba gufatwa nkibikorwa byabaye, ntabwo ari ibisobanuro birambuye.
Ingamba zingirakamaro hamwe na serivisi. Ba nyir'ibicuruzwa bagomba gusobanura ibikoresho bitangwa nk'ibicuruzwa, idirishya ryagenewe kuboneka, kandi niba abagurisha bayobora ibintu bimwe bigenzurwa.
Ibintu byihariye. Ikirangantego, ibara, nubunini bwamabere nibisanzwe kuri gahunda ya LD. Buri kimwe ni iboneza, kandi buri kimwe kigomba kugaragara mubisobanuro byemewe kugirango ibice byoherejwe, ibirimo kurutonde, hamwe na dosiye tekinike isobanura ibicuruzwa bimwe.
Amabere yo Kwemeza Amabere - Urutonde rwo gusaba Inzira isobanutse yo gucunga kariya gace ni urutonde rwanditse rwoherejwe kubakora mbere yuko gahunda itangwa. Igice nyacyo giterwa nikoreshwa ryagenewe, gutondekanya, hamwe nisoko ryerekanwe, kandi uwabikoze agomba kuba yiteguye kuvuga neza mugihe icyiciro kidakurikizwa aho kohereza icyemezo rusange mumwanya wacyo.
Icyiciro cy'inyandiko
Ibyo isanzwe ikubiyemo
Impamvu nyir'ikirango abikeneye
Sisitemu nziza
Icyemezo cya ISO 13485 gifite intera yavuzwe; MDSAP aho bishoboka
Ishimangira izindi nyandiko zose kandi zisanzwe zisabwa mubacuruzi kandi bamenyeshejwe ubugenzuzi bwumubiri
Ibinyabuzima
Isuzuma ryibikoresho byuruhu- n'amata bihuza na ISO 10993, harimo imiti iranga imiti aho ikoreshwa
Gushyigikira imenyekanisha ryibikoresho mubyangombwa bya tekiniki
Guhuza ibiryo no kubahiriza ibikoresho
Intego-isoko ibiryo-guhuza ibisabwa kuri amata-inzira ya polymers; Imenyekanisha rya BPA; RoHS na REACH aho bikenewe
Gupfuka ibice bifata cyangwa bitanga amata, hamwe nibikoresho bya elegitoroniki na polymer bigabanywa kubintu
Gucunga ibyago
Incamake ya dosiye yo gucunga ibyago ISO 14971 kuri moderi
Ikintu gisabwa cyangombwa cya tekiniki; ishyigikira imikoreshereze nibyemezo bya IFU
Umutekano w'amashanyarazi na EMC
Raporo yikizamini kubikoresho byamashanyarazi birwanya IEC 60601-1 na IEC 60601-1-2
Ibimenyetso bifatika byo kwandikisha pompe yamabere
Kugenzura imikorere
Igishushanyo mbonera cyo kugenzura urwego, uburyo, hamwe nimbibi za vacuum zidasobanutse neza
Shyigikira imikorere isaba kandi itandukanya ibicuruzwa kugirango uhagarare
Isuku, kwanduza, no kongera gukoresha
Kwemeza inzira yisuku yasobanuwe muri IFU, hiyongereyeho kongera gukoresha-cycle kubice byongeye gukoreshwa byamata
Komeza amabwiriza yatangajwe ajyanye nibikorwa byageragejwe
Gupakira, gutwara, no kuranga
Gutwara no gupakira kwemeza aho bishoboka; ikirango, IFU, na UDI amakuru
Kugabanya ibyangiritse-byangiritse kandi bishyigikira uburenganzira bwisoko
Kugenzura no kubona isoko
Kumenyekanisha guhuza, gukurikizwa kuri buri cyitegererezo cyerekana nka CE MDR, na 510 (k) aho bikenewe
Yemeza amasoko iboneza rishobora kwinjira
Ingeso ebyiri zituma uru rutonde rukora. Ubwa mbere, saba ibyangombwa kuri buri cyitegererezo no kuboneza, kuko icyemezo cyurwego rwisosiyete ntacyo kivuga kubijyanye nigice cyateganijwe. Icya kabiri, saba urutonde rwinyandiko rusubirwemo kandi igihe cyose ibikoresho-byerekana amata, ibikoresho, cyangwa iboneza ryamashanyarazi bihinduka - iyo niyo ngingo rwose aho gahunda yubahiriza ituje ihinduka itujuje ibisabwa.
Uburyo Joytech Ashyigikira Gahunda ya nyirubwite Ubuvuzi bwa Joytech bukora pompe yamabere murwego rwa LD, urwego ruri hagati yamashanyarazi asanzwe, amashanyarazi abiri, kwishyurwa, hamwe nubusa butagira amaboko.
Igishushanyo mbonera. Urutonde rwa LD urutonde rwibikoresho bidafite BPA, ingabo ya 24 mm ikingira amabere nkibisanzwe hamwe nubunini butaboneka burahari, no kuri moderi nka LD-209 ifunze-sisitemu, anti-gusubira inyuma hamwe nibintu bitandukanijwe rwose, byoroshye-gusukura ibice.
Ihuriro. Uburyo bune bwo kuvoma muburyo icyenda bwo guswera, kwerekana LED, itara rya nijoro, hamwe na batiri ya lithium ishobora kwishyurwa, Ubwoko-C, cyangwa AA imbaraga reka ikirango gisobanure ibyinjira, bisanzwe, kandi byongerewe imbaraga biva kumurongo umwe.
Ubwiza n'impamyabumenyi. Inganda zicaye munsi ya ISO 13485, MDSAP, na BSCI sisitemu yubuziranenge yemewe, hamwe na CE MDR na FDA iboneka kubintu byatoranijwe. Icyemezo cyemeza cyemejwe kuri buri cyitegererezo no ku isoko aho kugana aho gukoreshwa.
Guhitamo. Ikirangantego, ibara, nubunini bwamabere yingirakamaro gushyigikirwa muri gahunda ya OEM na ODM.
Ubushobozi nubuhanga. Ibigo 3 byo gukora, 260.000 m² y'ibikoresho byikora, imirongo 30+ yumusaruro, 100+ udushya twa patenti, hamwe na pompe yamabere yabugenewe R&D hamwe numurongo wo gutera inkunga gahunda-yumusaruro.
Umufatanyabikorwa natwe Porogaramu yo kuvoma amabere irashobora kwirwanaho gusa nkinyandiko ziri inyuma yibikoresho byayo. Joytech ikorana nabayikwirakwiza, abafite ibicuruzwa, hamwe nabaguzi ba OEM / ODM kugirango bahuze amata yo guhuza amata, ibikoresho byabigenewe, hamwe nimpapuro zemeza amasoko gahunda yubatswe.
Kugirango uganire kuri progaramu ya pompe yamabere, saba urutonde rwinyandiko, cyangwa utegure icyitegererezo cyo gusuzuma, hamagara sale14@sejoy.com .
Ibibazo
Q1: Nibihe bikoresho byo kuvoma amabere bisaba ibyangombwa byinshi?
Ibice bihuza ibice byamabere cyangwa amata yonsa bitwara ibisabwa cyane: ingabo zamabere, ibikoresho byo gukusanya, amacupa, indangagaciro, membrane, hamwe nigituba cyangwa kashe muburyo bwo guswera. Ibikoresho byo guturamo no kwerekana ibyerekanwe muri rusange n'umutekano w'amashanyarazi, EMC, n'ibimenyetso bibuza ibintu aho.
Q2: Ibikoresho bya pompe yamabere bikubiye mubyangombwa bimwe na pompe?
Ntabwo byikora, kandi iyi ni icyuho gisanzwe. Ibikoresho nkibindi bisimburana bya flange, amacupa, hamwe na valve byasimbuwe birashobora kumenyekanisha ibiryo byabo bwite, guhuza abana, cyangwa ibikenerwa byiyongera kubikoresho bya pompe. Ibikoresho byose bigomba kwemezwa kurwanya isoko.
Q3: Ni irihe tandukaniro riri hagati yicyemezo cyisosiyete nicyitegererezo cyihariye cyo kwemeza?
Icyemezo cya sosiyete, nkicyemezo cya ISO 13485, gisobanura sisitemu yubuziranenge. Icyitegererezo cyihariye cyo kwemeza ibyangombwa bisobanura igice nyacyo gitegekwa - ibikoresho byacyo, ibikoresho byacyo, ibikoresho byamashanyarazi, nibikorwa byagenzuwe. Abacuruzi n'abagenzuzi muri rusange biteze byombi, naho icya kabiri nicyo gishyigikira kwiyandikisha byihariye.
