Xa a Inkqubo yempompo yebele ihamba ukusuka kwingcamango ukuya kwimveliso, incoko yorhwebo idla ngokuqala ngefom factor, iindlela zokufunxa, kunye nexabiso. Incoko yokuthobela iqala kwenye indawo: oko kuchukunyiswa lubisi olumponthiweyo, zeziphi iindawo ezithunyelwa ngaphakathi kwebhokisi, kwaye ngawaphi amaxwebhu anokuthi akhutshwe ngumvelisi xa umlawuli, iqumrhu elaziswayo, okanye iqela lokuthotyelwa kwentengiso liwacela.
Kubathengi babucala kunye nabathengi be-OEM, impompo yemathiriyeli yamabele, izincedisi zempompo yamabele, kunye namaxwebhu okuqinisekisa impompo yamabele ayiyomijelo emithathu eyahlukeneyo. Ziyinkqubo enye, kwaye isikhewu kuyo nayiphi na kuzo sikholisa ukuvela emva kwexesha - njengokulibaziseka kobhaliso, ukususwa kuluhlu lwendawo yentengiso, okanye ibango lewaranti ebuyela emva kwindawo ekungekho mntu ubhaliweyo.
Kwimpompo yebele yombane, umbuzo wezinto eziphathekayo awunanto encinci yokwenza nombala wendlu okanye ukugqiba umboniso. Igxininisa kumalungu adibana nezicubu zebele okanye ubisi lwebele: isikhuselo sebele okanye iflenji, ikiti yokuqokelela ubisi kunye nebhotile, ivalve kunye nenwebu, nayiphi na iityhubhu, kunye netywina kunye nezihlanganisi ngaphakathi kwendlela yokufunxa.
Izigqibo ezimbini zoyilo ziseta umda waloo msebenzi phambi kokuba naluphi na uvavanyo lucelwe:
Vula inkqubo ngokuchasene nenkqubo evaliweyo. Kwimpompo yenkqubo evaliweyo, umqobo womzimba ugcina ubisi ngaphandle kwe-tubing kwaye kude ne-motor kunye ne-pneumatic path. Oko kunciphisa umphezulu woqhagamshelwano lobisi kwikiti yokuqokelela kwaye kunciphisa inani lamacandelo adinga ubungqina boqhagamshelwano lobisi.
Isebenziseka kwakhona xa ithelekiswa nenxalenye enye yokunxibelelana nobisi. Amacandelo enzelwe imijikelo ephindaphindiweyo, efana neeflange kunye nezixhobo zokuqokelela, zifuna ukucocwa kunye nokuphinda kusetyenziswe ukuqinisekiswa ukuba iindawo ezisetyenziswayo enye azifuni.
Itheyibhile engezantsi imisela ukuba umnini-brand kufuneka aqinisekise ntoni, icandelo lendawo ngokwecandelo.
Indawo yecandelo |
Indima yemathiriyeli eqhelekileyo |
Yintoni ekufuneka umnini-brand ayiqinisekise |
Ikhaka lesifuba / iflange |
I-Silicone okanye i-polymer eqinile edibanisa izicubu zebele kunye nobisi |
Ubungqina be-Biocompatibility yoqhagamshelwano lwesikhumba kunye nobisi; ubungakanani obuchaziweyo kunye nokunyamezela; indlela ubungakanani obukhethwayo obuchazwe ngayo kwifayile yobugcisa |
Ikhithi yokuqokelela, ibhotile, ivalve, inwebu |
Ukutya-uqhagamshelwano lwepolymer kunye neenxalenye ze-elastomer kwindlela yobisi |
Ukuthotyelwa kokutya kwimarike yendawo ekusingwa kuyo; Isibhengezo sasimahla se-BPA; ukucoca kunye nemiyalelo yokubulala iintsholongwane izinto eziphathekayo ziqinisekisiwe ukumelana |
Iityhubhu kunye neendlela zokufunxa |
Iityhubhu ze-elastomer kunye nezihlanganisi |
Ingaba uyilo luvaliwe inkqubo (akukho lubisi kwi-tubing); ukuba kuvuliwe, ubungqina bokuqhagamshelwa ngobisi kunye namathuba okutshintshwa |
Izindlu zeemoto, ulawulo, amandla |
Iiplastiki zobunjineli, umboniso, ibhetri |
Ukhuseleko lombane kunye nobungqina be-EMC bokulungiswa kombane; iilebhile, ukumakisha, kunye neemfuno zolwimi |
Ukupakishwa kunye nezinto eziprintiweyo |
Ikhathoni, iifake, IFU |
Uqinisekiso lwezothutho kunye neshelufu apho kuyimfuneko; Ugutyulo lolwimi lwe-IFU kwimarike yendawo nganye ekusingwa kuyo |
Imowudi yokungaphumeleli ephindaphindiweyo ifanelekile ukubiza igama. Umnini-brand uvuma isampuli kubumbeko olunye; imveliso ke endaweni yesibini-umthombo elastomer ivelufa, okanye ibakala abicah eyahlukileyo flange. Umntu obambeleyo unokwenza ngokulinganayo, kodwa iseti yamaxwebhu ayichanekanga ngoku. Ukutshintsha ulawulo kwimathiriyeli yokudibana nobisi kufuneka ke ngoko kuvunyelwene ngokubhaliweyo phambi kokuveliswa kobuninzi, kungaxoxiswana emva kokuba ibhetshi iphezu kwamanzi.
Izincedisi zePump yebele — Apho IiNkqubo zokuThobela zidla ngokutyibilika
Izixhobo zokuncedisa zithwala umngcipheko wothotyelo ongalinganiyo kuba ziphindaphinda ukubala kwe-SKU kwaye zitshintsha rhoqo kunempompo ngokwayo. Iyunithi enye yesiseko inokuvelisa ulungelelwaniso oluthengiswayo lweshumi elinesibini xa ubungakanani beflange, iibhotile, kunye neenketho zokuthwala zibaliwe.
Ukulinganisa ikhaka lesifuba. Isikhuselo sesifuba se-24 mm ngumgangatho oqhelekileyo, kunye neesayizi ezikhethiweyo ezifumaneka kwiqonga elifanayo. Isayizi nganye yinxalenye eyahlukileyo kunye nomzobo wayo kunye nezixhobo, kwaye nganye kufuneka ibonakaliswe kwinkcazo evunyiweyo kunokuba iphathwe njengokwahluka kweyunithi yesiseko.
Iibhotile kunye neendawo ezinxulumene nokondla. Ukuba inkqubo ithumela iibhotile okanye izikhongozeli zokugcina ubisi, ukusetyenziswa komntwana kunye neemfuno zoqhagamshelwano zokutya ezifana ne-EN 14350 zinokusebenza ecaleni kweemfuno zesixhobo, ngokuxhomekeke kwinxalenye kunye nemarike.
Iivalvu, i-membrane, kunye ne-tubing. Ezi ndawo zisebenzisekayo ziqhuba ukuthenga okuphindayo kunye nomsebenzi wasemva kokuthengisa. Iimbekiselo zenxalenye ezamkelweyo kufuneka zitshixiwe, kwaye utshintsho kwizinto ezityiwayo kufuneka zithathwe njengesiganeko soxwebhu, hayi iinkcukacha zemveliso.
Inxalenye esecaleni kunye nesicwangciso senkonzo. Abanini bebhrendi kufuneka bachaze ukuba zeziphi izincedisi ezibonelelwayo njengee-spare, ifestile yokufumaneka ecetywayo, kunye nokuba abasasazi baphinda ba-odole ngokuchasene nemigaqo efanayo elawulwayo.
Izinto zokwenza ngokwezifiso. I-logo, umbala, kunye nobukhulu bekhaka lesifuba zezona zixhaphakileyo kwiinkqubo ze-LD series. Ngamnye ulungelelwaniso, kwaye nganye kufuneka ibonakale kwinkcazo evunyiweyo ukwenzela ukuba iyunithi ethunyelweyo, umxholo woluhlu, kunye nefayile yobugcisa ichaza imveliso efanayo.
Uxwebhu loQinisekiso lweMpompo yebele — Uluhlu lokuQinisekisa oluCetywayo
Eyona ndlela icacileyo yokulawula le ndawo luluhlu lokukhangela olubhaliweyo oluthunyelwe kumenzi phambi kokuba inkqubo inikezelwe. Iseti ngqo ixhomekeke kusetyenziso olucetywayo, ulwahlulo, kunye nemarike yendawo ekuyiwa kuyo, kwaye umenzi kufuneka akulungele ukuxela ngokucacileyo xa udidi lungasetyenziswa kunokugqithisela isatifikethi segeneric endaweni yaso.
Uluhlu lwamaxwebhu |
Ibandakanya ntoni na |
Kutheni umnini-brand eyidinga |
Inkqubo yomgangatho |
Isatifikethi se-ISO 13485 esinomda ochaziweyo; I-MDSAP apho kuyimfuneko |
Ixhasa lonke olunye uxwebhu kwaye iyacelwa rhoqo kumthengisi kunye nophicotho-zincwadi lwebhodi |
Biocompatibility |
Uvavanyo lwezixhobo zokunxibelelana nolusu kunye nobisi ngokuchasene nothotho lwe-ISO 10993, kubandakanya ukubonakaliswa kwemichiza apho isetyenziswa khona. |
Ixhasa isibhengezo sezinto eziphathekayo kumaxwebhu obugcisa |
Ukutya-uqhagamshelwano kunye nokuthotyelwa kwezinto |
Iimfuno zokutya-zonxibelelwano lwentengiso yobisi kwiipolima zendlela yobisi; Isibhengezo sasimahla se-BPA; RoHS kunye ne-REACH apho kufanelekileyo |
Igquma amalungu abamba okanye ahambisa ubisi, kunye nezinto ze-elektroniki kunye ne-polymer ezixhomekeke kwizithintelo zeziyobisi |
Ulawulo lwengozi |
Isishwankathelo sefayile ye-ISO 14971 yolawulo lomngcipheko kwimodeli |
Into efunekayo yamaxwebhu obugcisa; ixhasa ukusetyenziswa kunye nezigqibo ze-IFU |
Ukhuseleko lombane kunye ne-EMC |
Iingxelo zovavanyo lolungelelwaniso lombane ngokuchasene ne-IEC 60601-1 kunye ne-IEC 60601-1-2 |
Ubungqina obungundoqo bokubhaliswa kwempompo yebele ene-powered |
Ukuqinisekiswa kokusebenza |
Ukuqinisekiswa koyilo lwamanqanaba okufunxa, iindlela, kunye nemida yokufunxa ngokuchasene neenkcukacha ezichaziweyo |
Ixhasa amabango okusebenza kwaye yahlule ukwahluka kwemveliso yokumiswa kwetshaneli |
Ukucoca, ukubulala iintsholongwane, kunye nokusetyenziswa kwakhona |
Ukuqinisekiswa kwenkqubo yokucoca echazwe kwi-IFU, kunye nedatha yomjikelo wokuphinda usetyenziswe kwiindawo eziphinda zisetyenziswe ubisi. |
Igcina imiyalelo epapashiweyo ihambelana nokusebenza kwezinto ezivavanyiweyo |
Ukupakishwa, uthutho, kunye nokuleyibhile |
Ukuqinisekiswa kwezothutho nokupakishwa apho kuyimfuneko; ileyibhile, IFU, kunye nedatha ye-UDI |
Yehlisa amabango omonakalo wohambo kwaye ixhasa ugunyaziso lwemarike |
Ufikelelo lolawulo kunye nemarike |
Isibhengezo sokuthotyelwa, izatifikethi ezisebenzayo zemodeli nganye ezifana ne-CE MDR, kunye ne-510(k) ubume apho kufanelekileyo. |
Iqinisekisa ukuba yeyiphi intengiso ulungelelwaniso oluchanekileyo olunokuthi lungene |
Imikhwa emibini yenza olu luhlu lusebenze. Okokuqala, cela uxwebhu ngemodeli nganye kunye noqwalaselo ngalunye, kuba isatifikethi senqanaba lenkampani asithethi nto malunga neyunithi iyalelwa. Okwesibini, cela uluhlu lwamaxwebhu ukuba luhlaziywe kwakhona nanini na xa unxibelelwano lobisi, i-accessory, okanye uhlengahlengiso lwamandla lutshintsha - yiloo ndawo kanye apho inkqubo ehambelanayo ngokuzolileyo iba yinto engathobeliyo.
Indlela iJoytech exhasa ngayo iiNkqubo zokuThotyelwa koMnini-Brand
I-Joytech Healthcare ivelisa iimpompo zebele ngaphakathi kwechungechunge lwe-LD, uluhlu oluthatha umbane oqhelekileyo, umbane ophindwe kabini, ohlawulelwayo, kunye nokulungiswa kwezandla.
Uyilo loqhagamshelwano lobisi. Iimodeli zothotho lwe-LD zidwelisa izixhobo ezingenazo i-BPA, ikhaka lesifuba elingama-24 mm njengomgangatho kunye nobukhulu obukhethiweyo obukhoyo, kunye nakwiimodeli ezinje nge I-LD-209 inkqubo evaliweyo, i-anti-backflow structure kunye ne-detachable ngokupheleleyo, izinto ezilula ukucoceka.
Amaqonga alungisekayo. Iimodi ezine zokumpompa kumanqanaba alithoba okufunxa, umboniso we-LED, isibane sasebusuku esizikhethelayo, kunye nebhetri ye-lithium egcwalisekayo, i-Type-C, okanye amandla e-AA vumela uphawu luchaze ukungena, umgangatho, kunye nokwahluka okuphuculweyo kwiqonga elinye.
Umgangatho kunye nesiqinisekiso. Ukwenziwa kwemveliso kuhlala phantsi kwe-ISO 13485, MDSAP, kunye neenkqubo zomgangatho oqinisekisiweyo we-BSCI, kunye ne-CE MDR kunye ne-FDA efumaneka kwiimodeli ezikhethiweyo. Ukhuseleko lwesatifikethi luqinisekisiwe ngemodeli nganye kunye nemarike yendawo ekusingwa kuyo kunokuba isetyenziswe kulo lonke uluhlu.
Ukwenza ngokwezifiso. Ilogo, umbala, kunye nesayizi yekhaka lesifuba zixhaswa ngaphakathi kwe-OEM kunye neenkqubo ze-ODM.
Ubunjineli kunye nobunjineli. 3 amaziko okuvelisa, 260,000 m² yezixhobo ezizenzekelayo, imigca yemveliso engama-30+, i-100+ yokwenziwa kwezinto ezintsha, kunye neqela elizinikeleyo lempompo yebele ye-R&D kunye nenkqubo yokuxhasa umgca wemveliso wokuvelisa.
Sebenzisana nathi
Inkqubo yempompo yebele ikhuseleke kuphela njengamaxwebhu emva kwezinto zayo kunye nezixhobo. I-Joytech isebenza nabasasazo, abanini beempawu, kunye nabathengi be-OEM/ODM ukulungelelanisa ukukhethwa kwezinto zoqhagamshelwano zobisi, ukulungelelaniswa kwe-accessory, kunye nokuqinisekiswa kwamaxwebhu kunye neemarike inkqubo eyakhelwe yona.
Ukuxoxa ngeprogram yempompo yebele, cela uluhlu lokutshekisha amaxwebhu, okanye ulungiselele iisampuli zokuvavanya, qhagamshelana sale14@sejoy.com.
FAQ
I-Q1: Zeziphi izinto zempompo zebele ezifuna amaxwebhu amaninzi?
Amalungu adibana nezicubu zebele okanye ubisi lwebele athwala eyona mfuno inzima: izikhuselo zamabele, izixhobo zokuqokelela, iibhotile, iivalvu, iinwebu, kunye nayo nayiphi na iityhubhu okanye itywina kwindlela yokufunxa. Izindlu kunye nezixhobo zokubonisa zigqunywa ngokubanzi kukhuseleko lombane, i-EMC, kunye nobungqina bothintelo lweziyobisi endaweni yoko.
I-Q2: Ngaba izixhobo zempompo zebele zihlanganiswe ngamaxwebhu afanayo kunye nempompo?
Akunjalo ngokuzenzekelayo, kwaye oku kungumsantsa oqhelekileyo. Izixhobo ezinje ngeesayizi zeflange ezitshiyeneyo, iibhotile, kunye neevalvu ezitshintshwayo zinokuzisa uqhagamshelwano lwazo lokutya, ukusetyenziswa komntwana, okanye iimfuno zemathiriyeli ukongeza kumaxwebhu esixhobo sempompo. Ubume besixhobo ngasinye kufuneka buqinisekiswe ngokuchasene nemarike yendawo ekusingwa kuyo.
I-Q3: Uthini umahluko phakathi kwesatifikethi senkampani kunye noxwebhu lokuqinisekisa olukhethekileyo?
Isatifikethi senkampani, esifana nesatifikethi sobubanzi be-ISO 13485, sichaza inkqubo yomgangatho. Amaxwebhu okuqinisekisa ngokuthe ngqo imodeli ichaza eyona yunithi iyalelwayo - izinto zayo, izixhobo zayo, ukumiswa kombane, kunye nokusebenza kwayo okuqinisekisiweyo. Abathengisi kunye nabalawuli ngokubanzi balindele zombini, kwaye okwesibini nguye oxhasa ubhaliso oluthile.
