I-FRO-203 CE FCC RR spo2 yezingane ishayela i-oximeter ukusetshenziswa kwe-pulse oximeter ekhaya
I-Narigmed's FRO-204 Fingertip Pulse Oximeter yakhelwe ukuqapha okuthembekile nokunembile kwezempilo ezimeni nasezindaweni ezihlukahlukene, ukuqinisekisa ukunakekelwa okuphelele kwabasebenzisi bayo yonke iminyaka.
Izici:
- Ukulinganisa Okunembe Kakhulu:Ngaphansi kwezimo zokugcwala okuphansi nge-PI=0.1%, ukunemba kwesilinganiso se-oxygen yegazi sika-Narigmed yi-SpO2 ±2%, PR ±2bpm.
- Ukusebenza Kwe-Anti-Motion:Ukunemba kokulinganisa izinga lokushaya kwenhliziyo ngu-±4bpm futhi ukunemba kokulinganisa kwe-SpO2 kungu-±3% ngisho nangaphansi kwezimo zokuzivocavoca.
-Amaphedi Eminwe Ahlanganiswe Ngokugcwele Nge-Silicone: Iqinisekisa ukunethezeka nokusetshenziswa okungenakho ukucindezelwa, okuvumela ukuqapha okunwetshiwe ngaphandle kokuphatheka kabi.
- Isilinganiso Esingeziwe Sokuphefumula (RR):Ivumela ukubhekwa kwesikhathi eside kwempilo yamaphaphu. (i-CE ne-NMPA iyatholakala).
- Okuphumayo Kwesilinganiso Esisheshayo:Inikeza ukuphuma kwepharamitha okusheshayo phakathi kwamasekhondi angu-4, iqinisekisa ukufundwa okufika ngesikhathi nokunembile.
- Bonisa Umsebenzi Wokuzungezisa Isikrini: Ithuthukisa ukusebenziseka ngokuvumela ukubuka kalula kuma-engeli ahlukene.
- Usizo Lwezempilo (Umbiko Wesimo Sezempilo):Ifaka umsebenzi wokwazisa wokuhlaziywa kwezempilo okwazisa abasebenzisi uma kusolwa i-hypoxia noma ukushaya kwenhliziyo okuphezulu, okuqinisekisa ukungenelela kwezokwelapha okufika ngesikhathi.
I-algorithm ye-anti-motion eyingqayizivele ye-Narigmed
Ama-oximeter ethu angcono kakhulu ekusebenzeni okulwa nokunyakaza, agcina izinga lokushaya kwenhliziyo kanye nokunemba kwesilinganiso senani le-oxygen egazini ngaphakathi kuka-± 4bpm noma ± ± 4% ngisho naphakathi kokunyakaziswa kweminwe okuqhubekayo noma ukunyakaziswa kwesikhawu. Noma ngabe uphakathi kwabantu abanempilo noma iziguli zika-Parkinson, ungaqinisekisa ukufundwa okuthembekile nokunembile. Idizayini enokwethenjelwa kanye nobuchwepheshe obuthuthukisiwe bedivayisi buyenza ifaneleke kakhulu ukuthola imiphumela yokuhlola enembile nethembekile yezindinganiso zezokwelapha ezinyakazayo.
Idizayinelwe abantu abanokundindizela kwezandla
I-pulse oximeter inobuchwepheshe bokulwa nokunyakaza, obuklanyelwe ngokukhethekile ukundindizela ezigulini zika-Parkinson.
Umklamo ongenamanzi
Isakhiwo esithuthukisiwe ngokukhethekile, sisengasebenza ngokujwayelekile uma kwenzeka ukuchaphaza kwamanzi ngezikhathi ezithile.
Isexwayiso Sangaphambi Kwemfiva kanye Nenyumoniya
I-fingertip pulse oximeter iyithuluzi elisebenzayo lokuthola ngokushesha amazinga e-oxygen ehlile egazini ezinganeni ngesikhathi somkhuhlane. Uma amazinga komoyampilo wegazi eqhubeka nokwehla ngesikhathi somkhuhlane, kuba yisixwayiso sangaphambi kwesikhathi, okubonisa isidingo sokunakekelwa ngokushesha kwezokwelapha ukuze kuvinjelwe inyumoniya ebangelwa imfiva ephezulu ethatha isikhathi eside. Lokhu kungenelela kusenesikhathi kungasiza ekuxilongeni nasekwelashweni okufika ngesikhathi, kuvikele impilo yengane yakho.
IMICIMBI
| UHLOBO | Ukuqapha Ikhaya\Idivayisi Yezokwelapha Yasekhaya |
| Isigaba | I-Pulse oximeter |
| Uchungechunge | narigmed® FRO-204 |
| Iphakheji | 1pcs/ibhokisi, 60box/ibhokisi |
| Uhlobo lokubonisa | I-LED EBOMVU |
| Bonisa ipharamitha | I-Spo2/PR/RR/PI/OLED |
| Ibanga lokulinganisa le-SpO2 | 35%~100% |
| Ukunemba kokulinganisa kwe-SpO2 | ±2% (70%~100%) |
| Ibanga lokulinganisa le-PR | 25 ~ 250bpm |
| Ukunemba kokulinganisa kwe-PR | Okukhulu okungu-±2bpm kanye ±2% |
| Ukusebenza kwe-Anti-motion | I-SpO2±3% I-PR ±4bpm |
| Ukusebenza kwe-perfusion ephansi | I-SPO2 ±2%, PR ±2bpm |
| Isikhathi sokuqala sokuphuma/Isikhathi sokulinganisa | 4s |
| Ukuvala shaqa okuzenzakalelayo | Vala ngemva kokuvala umunwe 8s\Ukuvala shaqa okuzenzakalelayo kumasekhondi angu-8 |
| Ukhululekile | I-Silicone cavity finger pad, ingagqokwa ngokunethezeka isikhathi eside |
| Inkomba yebhethri ephansi\Isimo sebhethri | YEBO |
| I-irradiance eguquguqukayo | Ukukhanya kwesikrini kuyalungiseka |
| Ukusetshenziswa kwamandla okujwayelekile | <30mA |
| Izisindo | 54g (nesikhwama esingenawo amabhethri) |
| I-Dimension | 63mm*35.6mm*32mm |
| Ubufakazi bamanzi | IPX2 |
| Isimo somkhiqizo | Imikhiqizo ethuthukisiwe |
| I-Voltage - Ukunikezwa | 2*1.5V AAA Amabhethri |
| Izinga Lokushisa Lokusebenza | 5°C ~ 40°C 15%~95%( umswakamo) 50kPa~107.4kPa |
| imvelo yokugcina | -20°C ~ 55°C 15%~95%( umswakamo) 50kPa~107.4kPa |
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.
