NOSN-06 DB9 Neonatal Disposable Sponge Strap Spo2 Probe
1.Uri fekitari?
Isu tiri sosi fekitori yemunwe pulse oximeter. Isu tine yedu yekurapa chigadzirwa chekunyoresa chitupa, kugadzirwa kwemhando system certification, yekugadzira patent, nezvimwe.
Tine anopfuura makore gumi ehunyanzvi uye ekiriniki kuunganidza kweICU monitors. Zvigadzirwa zvedu zvinoshandiswa zvakanyanya muICU, NICU, OR, ER, nezvimwe.
Isu tiri sosi fekitori inobatanidza R&D, kugadzira uye kutengesa. Kwete izvozvo chete, mune oximeter indasitiri, isu tiri sosi yezvakawanda masosi. Isu takapa ma module eokisijeni eropa kune vakawanda vanozivikanwa vanogadzira oximeter brand.
(Isu takanyorera akawanda ekugadzira patents uye chigadzirwa chitarisiko patents zvine chekuita nesoftware algorithms.)
Pamusoro pezvo, isu tine yakazara ISO:13485 manejimendi system, uye isu tinokwanisa kubatsira vatengi vane zvinoenderana nekunyoresa chigadzirwa.
2. Mwero weokisijeni muropa rako wakarurama here?
Chokwadika, kururama ndicho chinodikanwa chikuru chatinofanira kusangana nacho nokuda kwechitupa chezvokurapa. Isu hatisi kungosangana nezvinodiwa zvekutanga, asi isu tinotofunga nezve kurongeka mune zvakawanda zvakakosha zviitiko. Semuyenzaniso, kupindira kwekufamba, kushaya simba kweperipheral kutenderera, zvigunwe zvehukobvu hwakasiyana, zvigunwe zvemavara akasiyana eganda, nezvimwe.
Yedu yechokwadi yechokwadi ine anopfuura mazana maviri seti ekuenzanisa data inovhara huwandu hwe70% kusvika 100%, iyo inofananidzwa nemhedzisiro yekuongorora gasi reropa reropa remunhu.
Iko kurongeka kwechokwadi munharaunda yekurovedza muviri ndeye kushandisa maekisesaizi ekushandisa kurovedza neimwe frequency uye amplitude yekutepa, kukwenya, kufamba zvisina tsarukano, nezvimwewo, uye enzanisa mhedzisiro yebvunzo yeoximeter munzvimbo yekurovedza muviri nemhedzisiro yeropa gasi. analyzer for arterial blood Validation, zvingava zvinobatsira kune vamwe varwere vakadai sevarwere vane chirwere cheParkinson kuyera kushandiswa. Miedzo yekurwisa-kurovedza muviri parizvino inongoitwa chete nemakambani matatu eAmerica muindasitiri, masimo, nellcor, Philips, uye mhuri yedu chete ndiyo yakaita ongororo iyi nemunwe clip oximeters.
3. Nei oxygen yeropa ichichinja-chinja ichikwira nekudzika?
Chero bedzi iyo okisijeni yeropa ichichinja pakati pe96% ne100%, iri mukati meyakajairika. Kazhinji, kukosha kweokisijeni yeropa kunenge kwakadzikama pasi pekufema munzvimbo yakanyarara. Kuchinja-chinja kwechinhu chimwe kana zviviri muchikamu chidiki zvinowanzoitika.
Nekudaro, kana ruoko rwemunhu ruine kufamba kana kumwe kukanganisa uye shanduko mukufema, zvinokonzeresa kuchinja kukuru kweokisijeni yeropa. Naizvozvo, tinokurudzira kuti vashandisi vanyarare kana vachiyera ropa reokisijeni.
4. 4S inokurumidza kubuda kukosha, iko kukosha chaiko?
Iko hakuna marongero akadai se "yakasikwa kukosha" uye "yakagadziriswa kukosha" muropa redu oxygen algorithm. Hwaro hwese hunoratidzwa hunobva pakuunganidzwa kwemuviri wemuenzaniso uye kuongororwa. 4S yekukurumidza kukosha kuburitsa kunobva pakuzivikanwa nekukurumidza uye kugadzirisa kwepulse masaini akabatwa mukati me4S. Izvi zvinoda yakawanda yekiriniki data kuunganidza uye algorithm ongororo kuti uwane chaiyo yekuzivikanwa.
Nekudaro, chimiro chekukurumidza 4S kukosha kuburitsa ndechekuti mushandisi achiri. Kana paine kufamba kana foni ikavhurwa, iyo algorithm ichaona kuvimbika kweiyo data zvichienderana neakaunganidzwa waveform chimiro uye nekusarudza kuwedzera nguva yekuyera.
5. Inotsigira OEM uye kugadzirisa?
Tinogona kutsigira OEM uye kugadzirisa.
Nekudaro, sezvo iyo logo dhizaini yekudhinda inoda yakaparadzana skrini yekudhinda skrini uye yakaparadzana zvinhu uye bom manejimendi, izvi zvinotungamira mukuwedzera kwemutengo wechigadzirwa chedu uye mutengo wekutonga, saka isu tichava neiyo shoma yekuodha huwandu hunodiwa. MOQ:1K.
Iwo ma logo atinogona kupa anogona kuoneka pane chigadzirwa kurongedza, zvinyorwa, uye lens logos.
6. Zvinoita here kutengesa kunze kwenyika?
Isu parizvino tine Chirungu vhezheni yekurongedza, zvinyorwa uye zvigadzirwa zvemukati. Uye yakawana chitupa chekurapa kubva kuEuropean Union CE (MDR) uye FDA, iyo inogona kutsigira kutengesa kwepasirese.
Panguva imwecheteyo isu zvakare tine FSC yemahara yekutengesa chitupa (China neEU)
Nekudaro, kune dzimwe nyika dzakananga, zvinodikanwa kuti unzwisise zvinodiwa zvekusvika munharaunda, uye dzimwe nyika dzinodawo mvumo yakaparadzana.
Inyika ipi yauri kutumira kunze kwenyika? Rega ndisimbise nekambani kana nyika iyoyo ine zvakakosha zvekutonga zvinodiwa.
7. Zvinokwanisika here kutsigira kunyoresa munyika yeXX?
Dzimwe nyika dzinoda kumwe kunyoreswa kwevamiririri. Kana mumiririri achida kunyoresa zvigadzirwa zvedu munyika iyoyo, unogona kukumbira mumiririri kuti asimbise ruzivo rwavanoda kubva kwatiri. Tinogona kutsigira kupa ruzivo runotevera:
510K mvumo setifiketi
CE (MDR) mvumo setifiketi
ISO13485 qualification certificate
Product information
Zvinoenderana nemamiriro ezvinhu, zvinhu zvinotevera zvinogona kupihwa nesarudzo (zvinoda kubvumidzwa nemaneja wekutengesa):
General Safety Inspection Report for Medical Devices
Electromagnetic kuenderana bvunzo mushumo
Biocompatibility test report
Chigadzirwa chekiriniki report
8. Une chitupa chekuchipatara here?
Isu takaita zvemukati zvekurapa mudziyo kunyoresa uye certification, FDA's 510K certification, CE certification (MDR), uye ISO13485 certification.
Pakati pavo, takawana CE certification (CE0123) kubva kuTUV Süd (SUD), uye yakasimbiswa maererano nemitemo mitsva yeMDR. Parizvino, isu tiri vekutanga vekumba kugadzira kwemunwe clip oximeter.
Nezve kugadzirwa kwemhando yehurongwa, isu tine ISO13485 chitupa uye rezinesi rekugadzira mudzimba.
Pamusoro pezvo isu tine Yemahara Sale Sitifiketi (FSC)
9. Zvinoita here kuve mumiriri wega mudunhu?
Exclusive agency inogona kutsigirwa, asi isu tinofanirwa kukupa iwe chete kodzero dzesangano mushure mekunyorera kukambani mvumo zvichienderana nekushanda kwekambani yako uye inotarisirwa kutengesa huwandu.
Kazhinji iimwe nyika umo vamwe vamiririri vakuru vane pesvedzero huru yemuno uye mugove wemusika, uye vanoda kusimudzira zvigadzirwa zvedu, kuti vashande.
10. Zvigadzirwa zvako zvitsva here? Yave nenguva yakareba sei ichitengeswa?
Zvigadzirwa zvedu zvitsva uye zvave pamusika kwemwedzi mishoma. Izvo zvakagadzirirwa chete uye zvakamisikidzwa sezvigadzirwa zvepamusoro-soro. Isu parizvino tine vashoma nhamba yevatengi veOEM kutengesa. Nekuda kwechitupa chekunyoresa, haisati yapinda zviri pamutemo mumisika yeFDA neEC. Ichatengeswa kuNorth America neEuropean Union mushure mekuwana gwaro rekunyoresa muna Mbudzi.
11. Zvigadzirwa zvako zvakambotengeswa here? Ndeipi wongororo?
Kunyangwe zvigadzirwa zvedu zviri zvitsva, makumi ezviuru zvazvo zvakatumirwa kusvika zvino, uye mhando yechigadzirwa yakagadzikana. Tave tichigadzira oximeter kweanopfuura makore gumi, uye isu tinoziva nezve chero mutengi mhinduro matambudziko. Isu takaita kukundikana modhi yekuongorora (DFMEA/PFMEA) kune yega chikanganiso, kubva pakugadzirwa kwechigadzirwa nekusimudzira, kugadzirwa, mbishi kudzora mhando yemhando, kuongorora chigadzirwa, kurongedza Kudzora kunaka kwemaitiro ese, sekutakura, kudzivirira njodzi dzinogona kuitika.
Pamusoro pezvo, dhizaini yedu yechigadzirwa ine hunhu hwayo, inonzwa zvakanyanya, uye kuongororwa kwemutengi kwakakwira zvakanyanya.
12. Chigadzirwa chako imhando yega yega here? Pane njodzi yekukanganiswa here?
Iyi ndiyo yedu yakavanzika modhi, uye isu takanyorera kune yedu chigadzirwa chitarisiko patents uye ekugadzira patent ane chekuita nesoftware algorithms.
Kambani yedu ine munhu akazvipira ane basa rekuchengetedza zvigadzirwa zvehungwaru. Takaita ongororo yakazara yekodzero dzepfuma yezvigadzirwa zvedu, uye panguva imwe cheteyo takagadzira dhizaini yekuchengetedzwa kwepfuma yehungwaru yezvigadzirwa zvedu uye matekinoroji.
