Inzwa ye-NOPC-01 Silicone Wrap SPO2 Ngesixhumi se-lemo semojula yangaphakathi
Ividiyo Yomkhiqizo
Incazelo emfushane
I-Narigmed's NOPC-01 Silicone Wrap SpO2 Sensor ene-Inner Module kanye ne-Lemo Connector iyinzwa esebenza kahle kakhulu, esebenziseka kabusha eklanyelwe ukuqapha ukugcwala kwesimo komoyampilo okunembile. Yakhiwe kusuka ku-silicone ethambile, ye-hypoallergenic, iqinisekisa ukunethezeka kwesiguli futhi iletha ukufundwa okuthembekile kuzo zonke izilungiselelo zomtholampilo ezahlukahlukene. Isixhumi se-Lemo siqinisekisa ukuxhumana okuphephile nokusebenzayo okunamadivayisi ahambisanayo, okuyenza ifaneleke ukuqapha okuqhubekayo noma okubheka indawo. Le nzwa ehlukahlukene isekela ukusetshenziswa ezindaweni ezihlukahlukene, okuhlanganisa ukuphakama okuphezulu, ngaphandle, izibhedlela, amakhaya, ezemidlalo, nezimo zasebusika. Ihlanganisa ngaphandle komthungo nemishini efana nama-ventilators, amamonitha, nezigxili-moya zokwenza umoya-mpilo, okuvumela ukuthuthukiswa kwesofthiwe okulula ukuze kunikwe amandla ukuqapha komoyampilo wegazi ngaphandle kokushintsha umklamo wangempela wedivayisi, okuqinisekisa ukuguqulwa okungabizi nokuqondile.
Izici:
- Ukusebenza Okuphezulu Nokusebenziseka Kabusha:Idizayinelwe ukuqapha kwe-SpO₂ okunembile nokungaguquguquki okunokwakheka okuqinile, okusebenziseka kabusha.
- I-Soft Hypoallergenic Silicone:Iqinisekisa ukulingana okunethezekile, inciphisa ukucasuka kwesikhumba ezigulini.
- Isixhumi se-Lemo:Ihlinzeka ngoxhumano oluphephile nolusebenzayo ngamadivayisi ezokwelapha ahambisanayo.
- Ukusetshenziswa Okuhlukahlukene:Ifanele izindawo ezihlukahlukene, okuhlanganisa ukuphakama okuphezulu, ngaphandle, izibhedlela, amakhaya, ezemidlalo, nezimo zasebusika.
- Ukuhambisana Okuphelele:Ihlanganisa kalula nemishini efana nama-ventilators, amamonitha, nama-concentrator komoyampilo.
- Imojula Yegazi Oksijini Eyakhelwe Ngaphakathi:Ivumela ukulinganisa okunembile nokuqapha amazinga komoyampilo wegazi.
- Ukuvumelana Kokuthuthukiswa Kwesofthiwe:Inika amandla umsebenzi wokuqapha komoyampilo wegazi ngoshintsho olulula lwesofthiwe ngaphandle kokushintsha idizayini yedivayisi.
Izinzuzo:
- Induduzo Yesiguli:Ukugoqa okuthambile kwe-silicone kuqinisekisa ukunethezeka ngesikhathi sokusetshenziswa okunwetshiwe.
- Ukuxhumana Okuthembekile:Isixhumi se-Lemo siqinisekisa ukuxhumana okuphephile nokuphumelelayo namadivayisi wezokwelapha.
- Uhlelo lokusebenza olubanzi:Ifanele izindawo ezihlukahlukene futhi iyahambisana nezinhlobo eziningi zemishini yezokwelapha.
- Ukuthuthukiswa Okungabizi kakhulu:Inika amandla izinguquko ezilula nezinezindleko eziphansi ukwengeza ukusebenza kokuqapha komoyampilo wegazi kumishini ekhona.
- Ukusebenzisa kalula:Kulula ukuhlanganisa nokusebenzisa, okuyenza ilungele kokubili ukuqapha okuqhubekayo nokuhlola indawo.
Izici Ezilandelayo
1. Ukulinganisa okunembayo okuphezulu: Ukusebenzisa ubuchwepheshe be-algorithm ye-Narigmed ethuthukisiwe ukuze kuqinisekiswe ukunemba kwemiphumela yokulinganisa nokunciphisa amaphutha.
2. Ukuzwela okuphezulu: I-probe iklanyelwe ukuzwela futhi ingasabela ngokushesha ezinguqukweni zokugcwala komoyampilo egazini, inikeze idatha yesikhathi sangempela kumsebenzisi.
3. Ukuzinza okuqinile: Umkhiqizo uye wabhekana nokulawulwa kwekhwalithi okuqinile nokuhlolwa kokuzinza ukuze kuqinisekiswe ukuthi ungasebenza ngokuzinza ezindaweni ezihlukahlukene.
4. Kulula ukusebenza: Izesekeli zilula ekwakhiweni futhi kulula ukuzifaka. Zingaxhunywa kumgcini we-oximeter ngaphandle kokusebenza okuyinkimbinkimbi.
5. Iphephile futhi inokwethenjelwa: Yenziwe ngezinto ezisezingeni lezokwelapha, ezingenabuthi futhi ezingenabungozi, ezingacasuli isikhumba, ziqinisekisa ukusetshenziswa okuphephile.
6. Isevisi yokwenza ngokwezifiso: Isixhumi esibonakalayo esenziwe ngokwezifiso, ukwakheka kwenzwa ye-SPO2 eyenziwe ngokwezifiso, ubude bekhebula elenziwe ngokwezifiso, umsebenzi wemojula wepharamitha owenziwe ngokwezifiso nosayizi, igobolondo, ilogo.
1.Ingabe uyimboni?
Siwumthombo wemboni ye-finger pulse oximeter. Sinesitifiketi sethu sokubhaliswa komkhiqizo wezokwelapha, isitifiketi sekhwalithi yokukhiqiza, ilungelo lobunikazi lokusungula, njll.
Sineminyaka engaphezu kweshumi yokuqongelela kochwepheshe kanye nomtholampilo kwabaqaphi be-ICU. Imikhiqizo yethu isetshenziswa kabanzi ku-ICU, NICU, NOMA, ER, njll.
Siyimboni yomthombo ehlanganisa i-R&D, ukukhiqiza nokuthengisa. Akukhona lokho kuphela, embonini ye-oximeter, siwumthombo wemithombo eminingi. Sinikeze amamojula komoyampilo wegazi kubakhiqizi abaningi abaziwayo bohlobo lwe-oximeter.
(Sifake izicelo zamalungelo obunikazi amaningi okusungulwa kanye namalungelo obunikazi okubukeka komkhiqizo ahlobene ne-algorithms yesofthiwe.)
Ngaphezu kwalokho, sine-ISO:13485 uhlelo lokuphatha oluphelele, futhi singasiza amakhasimende ngokubhaliswa komkhiqizo okuhlobene.
2. Ingabe izinga le-oxygen egazini lakho linembile?
Yebo, ukunemba kuyimfuneko eyisisekelo okumelwe sihlangabezane nayo ukuze sithole isitifiketi sezokwelapha. Asigcini nje ngokuhlangabezana nezidingo eziyisisekelo, kodwa sicabangela nokunemba ezimweni eziningi ezikhethekile. Isibonelo, ukuphazamiseka kokunyakaza, ukujikeleza kwe-peripheral okubuthakathaka, iminwe yobukhulu obuhlukahlukene, iminwe yemibala ehlukene yesikhumba, njll.
Ukuqinisekisa kwethu ukunemba kunamasethi angaphezu kuka-200 edatha eqhathaniswayo ehlanganisa ububanzi obusuka ku-70% ukuya ku-100%, obuqhathaniswa nemiphumela yokuhlaziywa kwegesi yegazi legazi lomuntu.
Ukuqinisekisa ukunemba esimweni sokuzivocavoca ukusebenzisa amathuluzi okuzivocavoca ukuze uzivocavoce ngemvamisa ethile kanye ne-amplitude yokuthepha, ukungqubuzana, ukunyakaza okungahleliwe, njll., futhi uqhathanise imiphumela yokuhlolwa ye-oximeter esimweni sokuzivocavoca nemiphumela yegesi yegazi. i-analyzer yokuqinisekisa igazi le-arterial, kungaba usizo kwezinye iziguli njengeziguli ezine-Parkinson's disease ukukala ukusetshenziswa. Ukuhlola okunjalo okulwa nokuvivinya umzimba okwamanje kwenziwa kuphela izinkampani ezintathu zaseMelika embonini, i-masimo, i-nellcor, i-Philips, futhi umndeni wethu kuphela owenze lokhu kuqinisekisa ngama-oximeters wokunamathisela umunwe.
3. Kungani umoya-mpilo wegazi ushintshashintsha ukhuphuka uye phansi?
Uma nje umoya-mpilo wegazi uguquguquka phakathi kuka-96% no-100%, ungaphakathi kwebanga elijwayelekile. Ngokuvamile, inani le-oxygen egazini lizozinza nangaphansi kokuphefumula ngisho nasesimweni esithulile. Ukushintshashintsha kwevelu eyodwa noma amabili ebangeni elincane kuvamile.
Kodwa-ke, uma isandla somuntu sinokunyakaza noma okunye ukuphazamiseka kanye nezinguquko ekuphefumuleni, kuzodala ukushintshashintsha okukhulu kwe-oxygen yegazi. Ngakho-ke, sincoma ukuthi abasebenzisi bathule lapho bekala umoya-mpilo wegazi.
4. Inani lokuphumayo elisheshayo le-4S, ingabe inani langempela?
Awekho amasethingi afana “nenani elidaliwe” kanye “nenani eligxilile” ku-algorithm yethu yomoya-mpilo wegazi. Wonke amanani abonisiwe asekelwe ekuqoqweni kwemodeli yomzimba nokuhlaziya. Ukukhishwa kwevelu esheshayo ye-4S kusekelwe ekuhlonzweni okusheshayo nasekucutshungulweni kwamasignali okushaya kwenhliziyo athathwe ngaphakathi kwe-4S. Lokhu kudinga ukuqoqwa kwedatha eminingi yomtholampilo kanye nokuhlaziywa kwe-algorithm ukuze kuzuzwe ukuhlonza okunembile.
Nokho, isisekelo sokukhishwa kwenani elisheshayo le-4S ukuthi umsebenzisi usamile. Uma kukhona ukunyakaza uma ifoni ivuliwe, i-algorithm izonquma ukuthembeka kwedatha ngokusekelwe kumumo we-waveform eqoqiwe futhi ngokukhetha inwebe isikhathi sokulinganisa.
5. Ingabe isekela i-OEM nokwenza ngokwezifiso?
Singakwazi ukusekela i-OEM nokwenza ngokwezifiso.
Kodwa-ke, njengoba ukuphrinta kwesikrini selogo kudinga isikrini sokuphrinta sesikrini esihlukile kanye nezinto ezihlukene kanye nokuphathwa kwe-bom, lokhu kuzoholela ekwenyukeni kwezindleko zomkhiqizo wethu kanye nezindleko zokuphatha, ngakho-ke sizoba nemfuneko yenani elincane le-oda. I-MOQ:1K.
Amalogo esingawanikeza angavela emaphaketheni omkhiqizo, kumamanuwali, namalogo amalensi.
6. Kungenzeka yini ukuthumela ngaphandle?
Njengamanje sinezinguqulo zesiNgisi zokupakishwa, amamanuwali kanye nezindawo zokusebenzelana zomkhiqizo. Futhi ithole isitifiketi sezokwelapha ku-European Union CE (MDR) kanye ne-FDA, engasekela ukuthengiswa komhlaba wonke.
Ngasikhathi sinye siphinde sibe nesitifiketi sokuthengisa samahhala se-FSC (i-China ne-EU)
Nokho, kwamanye amazwe athile, kuyadingeka ukuqonda izidingo zokufinyelela endaweni, futhi amanye amazwe nawo adinga imvume ehlukile.
Iliphi izwe othumela kulo? Ake ngiqinisekise nenkampani ukuthi lelo zwe linezidingo ezikhethekile zokulawula.
7. Ingabe kungenzeka ukusekela ukubhaliswa ezweni XX?
Amanye amazwe adinga ukubhaliswa okwengeziwe kwabasebenzeli. Uma i-ejenti ifuna ukubhalisa imikhiqizo yethu kulelo zwe, ungacela i-ejenti ukuthi iqinisekise ukuthi yiluphi ulwazi oludingayo kithi. Singakusekela ukunikeza ulwazi olulandelayo:
Isitifiketi sokugunyazwa esingu-510K
Isitifiketi sokugunyazwa se-CE (MDR).
Isitifiketi sokufaneleka se-ISO13485
Ulwazi lomkhiqizo
Ngokwesimo, izinto ezilandelayo zinganikezwa ngokuzithandela (zidinga ukugunyazwa umphathi wezentengiso):
Umbiko Ojwayelekile Wokuhlola Ukuphepha Wamadivayisi Ezokwelapha
Umbiko wokuhlola ukuhambisana kwe-electromagnetic
Umbiko wokuhlolwa kwe-Biocompatibility
Umbiko womtholampilo womkhiqizo
8. Ingabe unaso isitifiketi semfundo yobudokotela?
Senze ukubhalisa nesitifiketi sedivayisi yezokwelapha yasekhaya, isitifiketi se-FDA sika-510K, isitifiketi se-CE (MDR), kanye nesitifiketi se-ISO13485.
Phakathi kwazo, sathola isitifiketi se-CE (CE0123) kwa-TUV Süd (SUD), futhi saqinisekiswa ngokuhambisana nemithetho emisha ye-MDR. Njengamanje, singabakhiqizi bokuqala basekhaya be-oximeter yesiqeshana somunwe.
Mayelana nesistimu yekhwalithi yokukhiqiza, sinesitifiketi se-ISO13485 nelayisense yokukhiqiza yasekhaya.
Ngaphezu kwalokho sineSitifiketi Sokuthengisa Samahhala (FSC)
9. Kungenzeka yini ukuba i-ejenti ekhethekile esifundeni?
I-ejensi ekhethekile ingasekelwa, kodwa sidinga ukukunikeza ngamalungelo e-ejensi akhethekile ngemva kokufaka isicelo enkampanini ukuze uthole imvume ngokusekelwe esimweni sokusebenza kwenkampani yakho kanye nenani lokuthengisa elilindelekile.
Ngokuvamile kuba yizwe elithile lapho ama-ejenti athile amakhulu anethonya elikhulu lendawo kanye nesabelo semakethe, futhi azimisele ukukhangisa imikhiqizo yethu, ukuze akwazi ukubambisana.
10. Ingabe imikhiqizo yakho misha? Isidayiswe isikhathi esingakanani?
Imikhiqizo yethu misha futhi isinezinyanga ezimbalwa isemakethe. Zakhiwe ngokukhethekile futhi zibekwe njengemikhiqizo esezingeni eliphezulu. Okwamanje sinenani elincane lamakhasimende okuthengiswa kwe-OEM. Ngenxa yesitifiketi sokubhalisa, asikangeni ngokusemthethweni ezimakethe ze-FDA ne-CE. Izothengiswa eNyakatho Melika nase-European Union ngemva kokuthola isitifiketi sokubhalisa ngoNovemba.
11. Ingabe imikhiqizo yakho yathengiswa ngaphambilini? Yini isibuyekezo?
Nakuba imikhiqizo yethu iyimikhiqizo emisha, amashumi ezinkulungwane zayo athunyelwe kuze kube manje, futhi ikhwalithi yomkhiqizo izinzile. Sesineminyaka engaphezu kweyishumi senza i-oximeter, futhi siyazi noma yiziphi izinkinga zempendulo yamakhasimende. Senze ukuhlaziywa kwemodi yokwehluleka (DFMEA/PFMEA) kukho konke ukungasebenzi, kusukela ekwakhiweni nasekuthuthukisweni komkhiqizo, ukukhiqizwa, ukulawulwa kwekhwalithi yezinto ezingavuthiwe, ukuhlolwa komkhiqizo, ukupakishwa Lawula ikhwalithi yayo yonke inqubo, njengokudiliva, ukugwema izingozi ezingaba khona.
Ngaphezu kwalokho, umklamo wethu womkhiqizo unezici zawo siqu, uzwela kakhulu, futhi nokuhlolwa kweklayenti kuphakeme kakhulu.
12. Ingabe umkhiqizo wakho uyimodeli yangasese? Ingabe ikhona ingozi yokwephulwa komthetho?
Lena imodeli yethu yangasese, futhi sifake isicelo samalungelo obunikazi okubonakala komkhiqizo wethu kanye namalungelo obunikazi okusungula ahlobene nama-algorithms esofthiwe.
Inkampani yethu inomuntu ozinikele onesibopho sokuvikela imikhiqizo yempahla yengqondo. Senze ukuhlaziya okuphelele kwamalungelo empahla yethu yengqondo yemikhiqizo yethu, futhi ngesikhathi esifanayo senza isakhiwo sokuvikelwa kwempahla ebhaliwe yengqondo yemikhiqizo yethu nobuchwepheshe.
