I-Nosn-04 Reusable Neonatal Spo2 Sensor Imataniswe Neseqa Sobhede Sesiguli
Izimfanelo Zomkhiqizo
| UHLOBO | Inzwa ye-spo2 esetshenziswa kabusha ifaniswe nemonitha yesiguli eseceleni kombhede |
| Isigaba | inzwa yokugoqa i-silicone spo2 \ inzwa ye-spo2 |
| Uchungechunge | narigmed® NOSN-04 |
| Bonisa ipharamitha | SPO2\PR\PI\RR |
| Ibanga lokulinganisa le-SpO2 | 35%~100% |
| Ukunemba kokulinganisa kwe-SpO2 | ±2% (70%~100%) |
| Isixazululo se-SpO2 | 1% |
| Ibanga lokulinganisa le-PR | 25 ~ 250bpm |
| Ukunemba kokulinganisa kwe-PR | Okukhulu okungu-±2bpm kanye ±2% |
| Isixazululo se-PR | 1bpm |
| Ukusebenza kwe-Anti-motion | I-SpO2±3% I-PR ±4bpm |
| Ukusebenza kwe-perfusion ephansi | I-SPO2 ±2%, PR ±2bpm Ingaba ngaphansi njenge-PI=0.025% ngophenyo luka-Narigmed |
| I-perfusion Index Range | 0%~20% |
| Isixazululo se-PI | 0.01% |
| Izinga lokuphefumula | Ongakukhetha, 4-70rpm |
| Isilinganiso sokulungiswa kwe-RR | 1 rpm |
| I-Plethyamo Graphy | Umdwebo webha\Pulse wave |
| Ukusetshenziswa kwamandla okujwayelekile | <20mA |
| Hlola ukutholwa | Yebo |
| Ukutholwa kokwehluleka kophenyo | Yebo |
| Isikhathi sokuqala sokuphuma | 4s |
| Hlola ukutholwa\Probe ukwehluleka ukutholwa | YEBO |
| Isicelo | Omdala / Wezingane / Osanda kuzalwa |
| Ukunikezwa kwamandla kagesi | 5V DC |
| Indlela yokuxhumana | Ukuxhumana kwe-TTL kwe-serial |
| Iphrothokholi yokuxhumana | ngokwezifiso |
| Usayizi | 2m |
| Isicelo | Ingasetshenziswa kumonitha |
| Izinga Lokushisa Lokusebenza | 0°C ~ 40°C 15%~95%( umswakamo) 50kPa~107.4kPa |
| imvelo yokugcina | -20°C ~ 60°C 15%~95%( umswakamo) 50kPa~107.4kPa |
Incazelo emfushane
I-blood probe ye-oxygen yakhelwe ukuhlangabezana nezidingo eziyingqayizivele zezingane ezisanda kuzalwa, ihlinzeka ngendlela emnene, engahlaseli ukuqapha amazinga azo komoyampilo wegazi. Ifakwe izinzwa ezithambile, nezinwebekayo ezilingana kahle nesikhumba sengane, enciphisa noma yikuphi ukungaphatheki kahle noma ukucasuka. I-probe iphinde yakhelwe ukuthi ihlale isikhathi eside futhi kulula ukuyihlanza, iqinisekisa ukuthi ingakwazi ukuhlangabezana nezidingo zansuku zonke zosana olusanda kuzalwa.
Ukwengeza, ama-blood oxygen probe ethu akhiqizwa ngezinga eliphezulu kakhulu namazinga okuphepha. Yenziwe ngezinto ezisezingeni lezokwelapha futhi iyi-hypoallergenic futhi iphephile esikhumbeni esithambile sezingane ezisanda kuzalwa. Le divayisi ihlolwa kanzima ukuze kuqinisekiswe ukwethembeka nokusebenza kwayo, okunikeza abasebenzisi ukuzethemba emandleni ayo okunikeza ukufundwa okunembile.
Esinye sezici ezibalulekile zokuhlola umoya-mpilo wethu wegazi ukunemba nokunemba kwazo. Ngokuhambisana nobuchwepheshe be-oksijini yegazi le-narigmed, uphenyo lisebenzisa ubuchwepheshe obuthuthuke kakhulu ukukala izinga le-oxygen egazini lengane ngesikhathi sangempela, okuvumela ukungenelela okufika ngesikhathi uma kutholakala izinkinga. Lokhu kubaluleke kakhulu ezinsaneni ezisanda kuzalwa, njengoba isistimu yazo yokuphefumula ekhulayo ingase ibe lula ekuguquguqukeni kumazinga omoya-mpilo. Ngokuphenya kwethu komoyampilo wegazi, abazali nabahlinzeki bezempilo bangaba nokuqiniseka ekunembeni kwezilinganiso zabo ukuze banikeze ukunakekelwa okufika ngesikhathi nangempumelelo lapho kudingeka. Ilungiselelwe ngokukhethekile futhi yathuthukiswa ukuze isebenze ngokumelene nokunyakaza nokusebenza okuphansi kwe-perfusion. Isibonelo, ngaphansi kokunyakaza okungahleliwe noma okuvamile kwe-0-4Hz, i-0-3cm, ukunemba kwe-pulse oximetry (SpO2) yi-± 3%, futhi ukunemba kokulinganisa kwezinga lokushaya kwenhliziyo ngu-± 4bpm. Uma inkomba ye-hypoperfusion inkulu noma ilingana no-0.025%, ukunemba kwe-pulse oximetry (SpO2) kungu-±2%, futhi ukunemba kokulinganisa izinga lokushaya kwenhliziyo ngu-±2bpm.
Ukubaluleka kokuqapha amazinga komoyampilo wegazi ezinganeni ezisanda kuzalwa angeke kugcizelelwe. Ezinganeni, ukugcinwa kwe-oxygen eyanele kubalulekile ekusekeleni ukukhula nokuthuthukiswa kwazo, ikakhulukazi ezigabeni zokuqala zokuphila. Ama-blood oxygen probe ethu ahlinzeka abazali nabahlinzeki bezempilo ngethuluzi elibalulekile lokulandelela amazinga komoyampilo wengane yabo, ukuhlonza noma yiziphi izinkinga ezingaba khona futhi banikeze ukungenelela okufika ngesikhathi. Noma ngabe ugada usana oluzalwe ngaphambi kwesikhathi e-NICU noma ugada ingane yakho ekhaya, ama-probe ethu ahlinzeka ngezilinganiso ezithembekile, ezinembile zokuthula kwengqondo.
Kafushane, ama-blood oxygen probes ethu ayithuluzi elibalulekile ekunakekelweni okusanda kuzalwa, anikeza ukunemba, ukwethembeka kanye nokusebenziseka kalula. Idizayini yayo emnene, engahlanyisi iyenza ifanelekele ngisho neziguli ezincane kakhulu, futhi izilinganiso zayo ezinembile zinikeza imininingwane ebalulekile ukusekela impilo nempilo yengane. Ngokuhlolwa kwethu komoyampilo wegazi, abazali nabahlinzeki bezempilo bangaqapha amazinga komoyampilo ezinsaneni zabo ngokuzethemba ukuze baqinisekise ukuthi zithola ukunakekelwa okungcono kakhulu.
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.
