Apo a chirongwa chepombi yemazamu inofamba kubva kupfungwa kuenda kukugadzirwa, iyo yekutengeserana nhaurirano inowanzotanga nechimiro chechimiro, yekuyamwa modes, uye mutengo. Hurukuro yekuteerera inotangira kumwewo: zvinobatwa nemukaka wakapomba, zvikamu zvipi zvinotumirwa mukati mebhokisi, uye ndeapi magwaro anogona kuburitswa nemugadziri kana mutongi, sangano rakaziviswa, kana timu yekuteerera yezvitoro yaakumbira.
Kune vakazvimiririra-label uye vatengi veOEM, mazamu epombi zvekushandisa, mazamu epombi yemidziyo, uye mapepa ekusimbisa pombi yemazamu haasi matatu akaparadzana emabasa. Iwo isystem imwe chete, uye gaka mune chero yadzo rinowanzo kunonoka - sekunonoka kunyoresa, kubviswa kwemusika rondedzero, kana waranti yekudaidzira inodzokera kune chikamu chisina munhu akanyorwa.
Papombi yemazamu yemagetsi, mubvunzo wemidziyo hauna chekuita neruvara rwemba kana kupera kwekuratidzira. Inotarisa pane zvikamu zvinosangana nematishu ezamu kana mukaka wezamu: nhovo yezamu kana flange, kiti yekuunganidza mukaka uye bhodhoro, vharafu uye membrane, chero tubing, uye zvisimbiso uye zvinobatanidza mukati menzira yekukweva.
Sarudzo mbiri dzekugadzira dzinoisa chiyero chebasa iro chero bvunzo isati yakumbirwa:
Vhura system maringe neyakavharwa system. Mune yakavharwa-system pombi, chinovharira chemuviri chinochengeta mukaka kubva muhubhu uye kure nemota uye pneumatic nzira. Izvo zvinomisa iyo mukaka-yekubata kumeso kune yekuunganidza kit uye inoderedza huwandu hwezvinhu zvinoda mukaka-yekubata humbowo.
Reusable against single-use mukaka-contact parts. Zvikamu zvakagadzirirwa kudzokororwa kutenderera, senge maflange uye makiti ekuunganidza, zvinoda kucheneswa uye kushandisazve kusimbiswa izvo zvisingashandisi-kamwe zvikamu.
Tafura iri pazasi inotaridza izvo muridzi wechiratidzo anowanzo fanirwa kusimbisa, chikamu chenzvimbo nenzvimbo.
Chikamu nzvimbo |
Basa rezvinhu zvakajairika |
Izvo muridzi wechiratidzo anofanira kusimbisa |
Chifuva nhovo / flange |
Silicone kana rigid polymer inobata mazamu nemukaka |
Biocompatibility uchapupu hweganda nemukaka kusangana; akaziviswa saizi uye tolerances; masaizi esarudzo anotsanangurwa sei muhunyanzvi faira |
Kit yekuunganidza, bhodhoro, vharafu, membrane |
Chikafu-kubata polymer uye elastomer zvikamu munzira yemukaka |
Chikafu-kusangana kutevedzera kumusika wekuenda; BPA-yemahara kuzivisa; kuchenesa uye disinfection mirayiridzo iyo zvinhu zvinosimbiswa kuti zvimire |
Tubing uye suction-nzira seals |
Elastomer tubing uye zvibatanidza |
Kunyangwe iyo dhizaini yakavharwa system (hapana mukaka mune tubing); kana yakavhurika, mukaka-kusangana humbowo uye kutsiva nguva |
Imba yemotokari, kutonga, simba |
Injiniya mapurasitiki, kuratidza, bhatiri |
Kuchengetedzwa kwemagetsi uye EMC humbowo hwekugadzirisa magetsi; zita, kumaka, uye zvinodiwa nemutauro |
Packaging uye zvakadhindwa zvinhu |
Carton, kuisa, IFU |
Kufambiswa uye pasherufu-hupenyu kusimbiswa kana zvichibvira; IFU mutauro wekuvhara pamusika wega wega wekuenda |
Imwe inodzokororwa yekutadza modhi yakakodzera kupihwa zita. Muridzi wechiratidzo anotendera sample mune imwe gadziriso; kugadzirwa kunobva kwatsiva yechipiri-sosi elastomer yevharuvhu, kana akasiyana silicone giredhi yeflange. Anotsiva anogona kuita zvakaenzana, asi zvinyorwa zvakaiswa zvino hazvina kunaka. Shanduko kutonga pamusoro pezvinhu zvinobata mukaka zvinofanirwa kubvumirana nekunyora kusati kwagadzirwa, kwete kutaurirana mushure mekunge batch iri mumvura.
Zvishandiso zvePombi Yezamu — Ipo Zvirongwa Zvekutevedzera Zvinowanzo Slip
Zvishandiso zvinotakura njodzi yekutevedzera isingaenzaniswi nekuti inowanza iyo SKU kuverenga uye inoshanduka kakawanda kupfuura pombi pachayo. Imwe base base unit inogona kugadzira gumi nemaviri inotengeswa masisitimu kana flange saizi, mabhodhoro, uye sarudzo dzekutakura dzaverengwa.
Breast shield sizeng. Iyo 24 mm yechipfuva nhovo yakajairika, ine sarudzo dzesaizi dzinowanikwa papuratifomu imwe chete. Saizi yega yega chikamu chakaparadzana chine kudhirowa kwayo uye zvishandiso, uye imwe neimwe inofanirwa kuratidzwa mune yakabvumidzwa yakatarwa pane kubatwa seyakasiyana ye base unit.
Mabhodhoro uye zvikamu zvine chekuita nekudya. Kana chirongwa chichiendesa mabhodhoro kana midziyo yekuchengetera mukaka, kushandiswa-kwevana uye chikafu-chekubata zvinodiwa se EN 14350 inogona kushanda pamwe nezvinodiwa nemudziyo, zvichienderana nechikamu uye musika.
Mavharuvhu, membranes, uye tubing. Izvi zvinodyiwa zvikamu zvinotyaira kudzokorora kutenga uye mushure-kutengesa chiitiko. Mareferensi echikamu akatenderwa anofanirwa kuvharwa, uye shanduko kune inodyiwa inofanirwa kubatwa sechiitiko chezvinyorwa, kwete ruzivo rwekugadzira.
Spare-chikamu uye sevhisi zano. Varidzi vemhando vanofanirwa kutsanangura kuti ndezvipi zvishongedzo zvinopihwa semaspare, iro rakatarisirwa kuwanikwa hwindo, uye kuti vanogovera varongezve vachipesana neyakafanana inodzorwa yakatarwa.
Customization zvinhu. Mucherechedzo, ruvara, uye saizi yenhovo yemazamu ndiyo yakajairika kune LD akatevedzana zvirongwa. Imwe neimwe igadziriso, uye imwe neimwe inofanirwa kuoneka mune yakabvumidzwa yakatarwa kuitira kuti iyo inotumirwa unit, iyo yezvinyorwa zvemukati, uye tekinoroji faira inotsanangura chimwe chete chigadzirwa.
Chinyorwa Chekusimbisa Pombi Yezamu - Rondedzero yekukumbira
Nzira yakajeka yekutonga nzvimbo iyi irondedzero yakanyorwa inotumirwa kumugadziri chirongwa chisati chapihwa. Iyo chaiyo seti inoenderana neyakagadzirirwa kushandiswa, kupatsanura, uye musika wekuenda, uye mugadziri anofanirwa kunge achida kutaura zvakajeka kana chikamu chikasashanda pane kutumira chitupa chegeneric panzvimbo yacho.
Document category |
Zvarinowanzo kufukidza |
Sei muridzi wechiratidzo achida |
Quality system |
ISO 13485 chitupa chine chiyero chakataurwa; MDSAP pazvinoshanda |
Inotsigira mamwe magwaro ese uye inogara ichikumbirwa muzvitoro uye inoziviswa kuongororwa kwemuviri |
Biocompatibility |
Ongororo yeganda- uye mukaka-yekubata zvinhu zvichipesana ne ISO 10993 yakatevedzana, kusanganisira kemikari hunhu painoshandiswa. |
Inotsigira chiziviso chemidziyo muzvinyorwa zvehunyanzvi |
Chikafu-kusangana uye kuenderana kwezvinhu |
Kuenda-musika chikafu-kusangana zvinodiwa kuti mukaka-nzira polima; BPA-yemahara kuzivisa; RoHS uye REACH pazvinenge zvakakodzera |
Inovhara zvikamu zvinobata kana kuendesa mukaka, uye zvemagetsi uye zvepolymer zvikamu zviri pasi pezvirambidzo zvezvinhu |
Risk management |
Pfupiso yeiyo ISO 14971 njodzi manejimendi faira remuenzaniso |
Chinhu chinodiwa chezvinyorwa zvinyorwa; inotsigira usability uye IFU sarudzo |
Kuchengetedzwa kwemagetsi uye EMC |
Mishumo yekuyedza yekumisikidzwa kwemagetsi inopesana neIEC 60601-1 uye IEC 60601-1-2. |
Humbowo hwakakosha hwekunyoreswa kwepombi yemazamu ine powered |
Performance verification |
Dhizaini yekusimbisa mazinga ekuyamwa, modhi, uye vacuum miganho inopesana neakatsanangurwa |
Inotsigira zvichemo zvekuita uye inoparadzanisa zvigadzirwa zvakasiyana-siyana zvekumisikidza chiteshi |
Kuchenesa, kuuraya utachiona, uye kushandisazve |
Kusimbiswa kweiyo nzira yekuchenesa inotsanangurwa muIFU, pamwe nekushandisazve-kutenderera data kune inoshandisikazve mukaka-inobata zvikamu. |
Inochengeta mirairo yakadhindwa inoenderana neyakaedzwa kuita zvinhu |
Kurongedza, kutakura, uye kunyora |
Kugadziriswa kwekutakura uye kurongedza pazvinenge zvakakodzera; label, IFU, uye UDI data |
Inoderedza zvichemo zvekukuvara kwekufambisa uye inotsigira mvumo yemusika |
Regulatory uye musika kuwana |
Declaration of conformity, inoshanda per-model zvitupa seEC MDR, uye 510 (k) chinzvimbo pazvinenge zvakakodzera. |
Inosimbisa iyo inoshambadzira iyo chaiyo gadziriso inogona kupinda |
Tsika mbiri dzinoita kuti chinyorwa ichi chishande. Chekutanga, kumbira zvinyorwa pamuenzaniso uye nekumisikidzwa, nekuti chitupa chechikamu chekambani hachitauri nezvechikamu chiri kurairwa. Chechipiri, kumbira kuti runyoro rwegwaro rudzokororwe zvakare pese panochinja zvinhu zvinosangana nemukaka, chishongedzo, kana simba - ndiyo chaiyo nguva iyo chirongwa chinoenderana chinyararire chinova chisingaite.
Maitiro eJoytech Inotsigira Brand Muridzi Kutevedzera Zvirongwa
Joytech Healthcare inogadzira pombi yemazamu mukati meLD mutsara, huwandu hunoenderana nemagetsi akajairwa, kaviri magetsi, anogona kudzokororwa, uye asina maoko-magadzirirwo.
Mukaka-kusangana dhizaini. LD akateedzana modhi anonyora BPA-yemahara zvinhu, 24 mm mazamu nhoo seyakajairwa ine sarudzo saizi iripo, uye pamhando dzakadai se LD-209 yakavharwa-system, anti-backflow dhizaini ine inobviswa zvizere, zviri nyore-kuchenesa zvikamu.
Configurable platforms. Mamodhi mana ekupomba pamazinga mapfumbamwe ekuyamwa, ratidziro ye LED, mwenje wehusiku wesarudzo, uye rechargeable lithium bhatiri, Type-C, kana AA simba rega brand itsanangure yekupinda, yakajairwa, uye yakakwidziridzwa misiyano kubva papuratifomu imwe.
Hunhu uye chitupa. Kugadzira kunogara pasi peISO 13485, MDSAP, uye BSCI yakasimbiswa mhando masisitimu, ine CE MDR uye FDA kufukidzwa kunowanikwa pamhando dzakasarudzwa. Certification yekuvhara inosimbiswa pa modhi uye pamusika wekuenda pane kuisirwa mukati memhando.
Customization. Mucherechedzo, ruvara, uye mazamu shield size customization inotsigirwa mukati meOEM neODM zvirongwa.
Kugona uye engineering. 3 kugadzira nzvimbo, 260,000 m² yezvivakwa zveotomatiki, mitsara makumi matatu+ yekugadzira, 100+ patented innovation, uye yakazvipira yezamu pombi R&D timu uye yekugadzira mutsara wekutsigira chirongwa-chiyero kugadzirwa.
Shamwaridzana Nesu
Chirongwa chepombi yemazamu inongodzivirirwa semagwaro ari kuseri kwezvinhu zvayo uye zvishongedzo. Joytech inoshanda nevashambadzi, varidzi vemhando, uye vatengi veOEM/ODM kuti vaenzanise sarudzo yemukaka-yekubata zvinhu, gadziriso yezvishandiso, uye magwaro ekusimbisa nemisika chirongwa chakavakirwa.
Kuti ukurukure chirongwa chepombi yemazamu, kumbira gwaro rekutarisa, kana kuronga maevaluation samples, kubata sale14@sejoy.com.
FAQ
Q1: Ndezvipi zvinhu zvepombi yemazamu zvinoda zvinyorwa zvakanyanya?
Zvikamu zvinobata matishu emuzamu kana mukaka wezamu zvinotakura zvinorema zvakanyanya: nhovo dzezamu, kits dzekuunganidza, mabhodhoro, mavharuvhu, membrane, uye chero tubing kana zvisimbiso munzira yekukweva. Zvivakwa zvedzimba uye zvekuratidzira zvinowanzofukidzwa nekuchengetedzwa kwemagetsi, EMC, uye humbowo hwekudzivirira zvinhu panzvimbo.
Q2: Zvishandiso zvepombi yemazamu zvakavharwa nemagwaro akafanana nepombi?
Kwete otomatiki, uye iri ndiro gaka rakajairika. Zvishandiso zvakaita semamwe saizi yeflange, mabhodhoro, uye mavharuvhu ekutsiva anogona kuunza yavo yekudya-yekuonana, kushandisa-mwana, kana zvinhu zvinodiwa mukuwedzera kune zvinyorwa zvepombi. Yese yezvishandiso zvigadziriso zvinofanirwa kusimbiswa zvichienderana nemusika wekuenda.
Q3: Ndeupi musiyano uripo pakati pechitupa chekambani uye modhi-yakananga magwaro ekusimbisa?
Chitupa chekambani, senge ISO 13485 scope certificate, inotsanangura hurongwa hwemhando. Manyoro emuenzaniso chaiwo anotsanangura iyo chaiyo unit iri kuodha - zvinhu zvayo, zvishongedzo zvayo, gadziriso yemagetsi, uye kushanda kwayo kwakasimbiswa. Vatengesi uye vatongi vanowanzotarisira zvese, uye yechipiri ndiyo inotsigira kunyoreswa kwakati.
