I-NOSZ-09 Izixhobo ezikhethekileyo zomsila wesilwanyana kunye neenyawo
Ingcaciso emfutshane
I-1.Umlinganiselo ophezulu wokuchaneka: Yamkela iteknoloji ye-algorithm ye-narigmed ephezulu ukuqinisekisa ukuchaneka kweziphumo zokulinganisa kunye nokunciphisa iimpazamo.
I-2.Uvakalelo oluphezulu: I-probe yenzelwe ukuba ibe novelwano kwaye inokusabela ngokukhawuleza kwiinguqu kwi-saturation ye-oxygen yegazi yezilwanyana, inikezela ngedatha yexesha langempela kwiingcali zezilwanyana.
I-3.Uzinzo olomeleleyo: Imveliso iye yafumana ulawulo oluqinileyo lomgangatho kunye nokuvavanya ukuzinza ukuqinisekisa ukuba inokusebenza ngokuzinzileyo kwiindawo ezahlukeneyo.
I-4.Easy ukusebenza: Izixhobo zilula kuyilo kwaye kulula ukuzifaka. Bangakwazi ukudibaniswa nomphathi we-oximeter yezilwanyana ngaphandle kwemisebenzi enzima.
I-5.Ikhuselekile kwaye inokwethenjelwa: Yenziwe ngezinto ezikumgangatho wezonyango, ezingenayo ityhefu kwaye zingenabungozi, zingacaphukisi ulusu lwezilwanyana, ziqinisekisa ukusetyenziswa ngokukhuselekileyo.
Iimeko zeSicelo
Le mveliso ifanelekile ukujongwa kwe-oksijini yegazi kwizilwanyana zasekhaya ezahlukeneyo (ezifana neekati, izinja, imivundla, njl.) kunye nemfuyo (efana neenkomo, iigusha, iihagu, njl.). Inexabiso lesicelo esibanzi kuqhaqho lwezilwanyana, ukhathalelo olunzulu, unyango lokubuyisela kwisimo sangaphambili kunye nezinye izihlandlo.
Imiyalelo
1. Xhuma i-accessory ye-probe kumzimba oyintloko we-oximeter yezilwanyana, uqinisekise ukuba uxhulumaniso luzinzile.
2. Coca ulusu lwendawo yokulinganisa isilwanyana ukuqinisekisa ukuba ayinabumdaka, igrisi kunye nobunye ukungcola.
3. Qhoboshela iprobe ngobunono kwisikhumba sesilwanyana, uqinisekise ukuba iprobe isondelelene nolusu.
4. Vula iyunithi ephambili ye-oximeter yonyango lwezilwanyana kwaye uqalise ukubeka iliso kwi-oxygen saturation egazini lesilwanyana.
5. Ngethuba lenkqubo yokubeka iliso, qaphela ukusabela kwesilwanyana kwaye ujongane nayo ngokukhawuleza ukuba kukho naziphi na izinto ezingaqhelekanga.
1.Ngaba ungumzi mveliso?
Singumthombo wemveliso we-finger pulse oximeter. Sinesethu isiqinisekiso sobhaliso lwemveliso yezonyango, isiqinisekiso senkqubo yomgangatho wemveliso, ipatent yokuqamba, njl.
Sineminyaka engaphezu kweshumi yoqokelelo lobugcisa kunye nonyango lwabahloli be-ICU. Iimveliso zethu zisetyenziswa ngokubanzi kwi-ICU, NICU, OKANYE, ER, njl.
Singumthombo wemveliso odibanisa i-R&D, imveliso kunye nokuthengisa. Akunjalo kuphela, kwishishini le-oximeter, singumthombo wemithombo emininzi. Sinikeze iimodyuli ze-oksijini yegazi kubakhiqizi abaninzi abaziwayo be-oximeter brand.
(Sifake izicelo zamalungelo awodwa omenzi wechiza amaninzi kunye nembonakalo yemveliso enxulumene ne-algorithms yesoftware.)
Ukongeza, sine-ISO epheleleyo: inkqubo yolawulo ye-13485, kwaye sinokunceda abathengi ngokubhaliswa kwemveliso ehambelanayo.
2. Ngaba inqanaba le-oxygen egazini lakho lichanekile?
Kakade ke, ukuchaneka yeyona mfuneko isisiseko ekufuneka sihlangabezane nayo ukuze sifumane isiqinisekiso sonyango. Asigcini nje ukuhlangabezana neemfuno ezisisiseko, kodwa sicinga nokuchaneka kwiimeko ezininzi ezikhethekileyo. Ngokomzekelo, ukuphazamiseka kwentshukumo, ukujikeleza okubuthakathaka kwe-peripheral, iminwe yobunzima obuhlukeneyo, iminwe yemibala eyahlukeneyo yesikhumba, njl.
Ukuqinisekiswa kwethu kokuchaneka kuneesethi ezingaphezu kwama-200 zedatha ethelekisayo egubungela uluhlu lwe-70% ukuya kwi-100%, efaniswa neziphumo zohlalutyo lwegesi yegazi kwi-arterial blood.
Ukuqinisekiswa kokuchaneka kwimeko yokuzivocavoca kukusebenzisa izixhobo zokuzilolonga kunye ne-frequency ethile kunye ne-amplitude yokucofa, ukungqubuzana, ukunyakaza okungahleliwe, njl., kwaye uthelekise iziphumo zovavanyo lwe-oximeter kwimeko yokuzivocavoca kunye neziphumo zegesi yegazi. i-analyzer yokuqinisekiswa kwegazi, kuya kuba luncedo kwezinye izigulana ezifana nezigulane ezine-Parkinson's disease ukulinganisa ukusetyenziswa. Uvavanyo olunjalo lokulwa nokuzilolonga okwangoku lwenziwa kuphela ziinkampani ezintathu zaseMelika kushishino, imasimo, i-nellcor, iPhilips, kwaye yintsapho yethu kuphela eye yenze le ngqinisekiso ngeclip oximeters yomnwe.
3. Kutheni ioksijini yegazi ihla inyuka inyuka?
Ngethuba nje i-oxygen yegazi iguquguquka phakathi kwe-96% kunye ne-100%, ingaphakathi koluhlu oluqhelekileyo. Ngokubanzi, ixabiso le-oksijini yegazi liya kuzinza ngokulinganayo naphantsi kokuphefumla kwindawo ezolileyo. Ukuguquguquka kwexabiso elinye okanye amabini kuluhlu oluncinci luqhelekileyo.
Nangona kunjalo, ukuba isandla somntu sinentshukumo okanye ezinye iziphazamiso kunye nokutshintsha kokuphefumla, kuya kubangela ukuguquguquka okukhulu kwi-oxygen yegazi. Ke ngoko, sicebisa ukuba abasebenzisi bathule xa belinganisa ioksijini yegazi.
4. Ixabiso lemveliso ekhawulezayo ye-4S, ngaba lixabiso lokwenyani?
Akukho zicwangciso ezifana "nexabiso elidaliweyo" kunye "nexabiso eliqingqiweyo" kwi-algorithm ye-oxygen yegazi. Onke amaxabiso abonisiwe asekelwe kwingqokelela yemodeli yomzimba kunye nohlalutyo. Imveliso yexabiso elikhawulezayo le-4S isekelwe ekuchongeni ngokukhawuleza kunye nokusetyenzwa kweempawu ze-pulse ezifakwe ngaphakathi kwe-4S. Oku kufuna ubuninzi bedatha yeklinikhi kunye nohlalutyo lwe-algorithm ukufezekisa ukuchongwa ngokuchanekileyo.
Nangona kunjalo, isiseko semveliso yexabiso le-4S ekhawulezayo kukuba umsebenzisi usenjalo. Ukuba kukho intshukumo xa ifowuni ivuliwe, i-algorithm iya kugqiba ukuthembeka kwedatha ngokusekelwe kwimilo ye-waveform eqokelelweyo kwaye ngokukhetha ukwandisa ixesha lokulinganisa.
5. Ngaba ixhasa i-OEM kunye nokwenza ngokwezifiso?
Sinokuxhasa i-OEM kunye nokwenza ngokwezifiso.
Nangona kunjalo, ekubeni ukuprintwa kwesikrini se-logo kufuna isikrini sokuprinta isikrini esahlukileyo kunye nezinto ezihlukeneyo kunye nolawulo lwe-bom, oku kuya kukhokelela ekunyukeni kweendleko zethu zemveliso kunye neendleko zokulawula, ngoko siya kuba nemfuneko yobungakanani obuncinci bomyalelo. MOQ:1K.
Iilogo esinokuzibonelela ngazo zinokuvela kwipakethe yemveliso, kwiincwadana, nakwiilogo zelensi.
6. Ngaba kunokwenzeka ukuthumela ngaphandle?
Okwangoku sineenguqulelo zesiNgesi zokupakishwa, iimanyuwali kunye nojongano lwemveliso. Kwaye ifumene isatifikethi sonyango kwi-European Union CE (MDR) kunye ne-FDA, enokuxhasa ukuthengiswa kwehlabathi.
Kwangaxeshanye sinesiqinisekiso sokuthengisa sasimahla se-FSC (eTshayina kunye ne-EU)
Nangona kunjalo, kwamanye amazwe athile, kuyimfuneko ukuqonda iimfuno zokufikelela kwingingqi, kwaye amanye amazwe afuna imvume eyahlukileyo.
Leliphi ilizwe othumela kulo? Mandiqinisekise kunye nenkampani ukuba elo lizwe lineemfuno ezikhethekileyo zolawulo.
7. Ngaba kunokwenzeka ukuxhasa ukubhaliswa kwilizwe le-XX?
Amanye amazwe afuna ubhaliso olongezelelweyo kwiiarhente. Ukuba i-arhente ifuna ukubhalisa iimveliso zethu kwelo lizwe, unokucela i-arhente ukuba iqinisekise ukuba loluphi ulwazi oludingayo kuthi. Sinokuxhasa ukunika olu lwazi lulandelayo:
Isiqinisekiso sogunyaziso se-510K
CE (MDR) isatifikethi sogunyaziso
Isiqinisekiso sesiqinisekiso se-ISO13485
Ulwazi lwemveliso
Ngokwemeko, ezi zixhobo zilandelayo zinokubonelelwa ngokuzikhethela (kufuneka zivunywe ngumphathi wentengiso):
Ingxelo yoHlolo loKhuseleko Jikelele kwiZixhobo zoNyango
Ingxelo yovavanyo lokuhambelana kwe-Electromagnetic
Ingxelo yovavanyo lwe-Biocompatibility
Ingxelo yeklinikhi yemveliso
8. Ingaba unaso isiqinisekiso sonyango?
Senze ubhaliso lwezixhobo zonyango lwasekhaya kunye nesiqinisekiso, i-FDA's 510K certification, CE certification (MDR), kunye ne-ISO13485 certification.
Phakathi kwabo, safumana isatifikethi se-CE (CE0123) esivela kwi-TUV Süd (SUD), kwaye yaqinisekiswa ngokuhambelana nemigaqo emitsha ye-MDR. Okwangoku, singumvelisi wokuqala wasekhaya we-clip oximeter yomnwe.
Ngokuphathelele inkqubo yomgangatho wemveliso, sinesiqinisekiso se-ISO13485 kunye nelayisenisi yemveliso yasekhaya.
Ukongeza, sineSiqinisekiso soThengiso lwamahala (FSC)
9. Ngaba kunokwenzeka ukuba ube yiarhente eyodwa kummandla?
I-arhente eyodwa inokuxhaswa, kodwa kufuneka sikubonelele ngamalungelo akhethekileyo e-arhente emva kokufaka isicelo kwinkampani ukuba yamkelwe ngokusekelwe kwimeko yokusebenza kwenkampani yakho kunye nomthamo olindelekileyo wentengiso.
Ngokuqhelekileyo lilizwe elithile apho ezinye ii-arhente ezinkulu zinempembelelo enkulu yasekhaya kunye nesabelo semarike, kwaye zikulungele ukukhuthaza iimveliso zethu, ukuze zibe nokusebenzisana.
10. Ngaba iimveliso zakho zintsha? Ithengisiwe ixesha elingakanani?
Iimveliso zethu zintsha kwaye bezikwimarike iinyanga ezimbalwa. Ziyilwe kuphela kwaye zibekwe njengeemveliso eziphezulu. Okwangoku sinenani elincinci labathengi kwiintengiso ze-OEM. Ngenxa yesatifikethi sobhaliso, asikangeni ngokusemthethweni kwiimarike ze-FDA kunye ne-CE. Iza kuthengiswa eMntla Melika nakwi-European Union emva kokufumana isatifikethi sokubhalisa ngoNovemba.
11. Ngaba iimveliso zakho bezithengisiwe ngaphambili? Luthini uphononongo?
Nangona iimveliso zethu ziyimveliso entsha, amashumi amawaka azo sele ethunyelwe ngoku, kwaye umgangatho wemveliso uzinzile. Senze i-oximeter iminyaka engaphezu kweshumi, kwaye siyayazi nayiphi na ingxaki yempendulo yabathengi. Senze uhlalutyo lwemowudi yokungaphumeleli (DFMEA/PFMEA) kuso sonke isiphene, ukusuka kuyilo lwemveliso kunye nophuhliso, imveliso, ukulawulwa komgangatho wezinto ezikrwada, ukuhlolwa kwemveliso, ukupakishwa Ukulawulwa komgangatho wenkqubo yonke, njengokuhanjiswa, ukuphepha ubungozi obunokwenzeka.
Ukongeza, uyilo lwethu lwemveliso luneempawu zalo, lunovakalelo kakhulu, kwaye uvavanyo lwabaxumi luphezulu kakhulu.
12. Ngaba imveliso yakho imodeli yabucala? Ngaba kukho nawuphi na umngcipheko wokophulwa?
Le yimodeli yethu yabucala, kwaye siye safaka isicelo samalungelo awodwa abenzi bembonakalo yemveliso kunye nelungelo elilodwa lomenzi wechiza elinxulumene ne-software algorithms.
Inkampani yethu inomntu ozinikeleyo onoxanduva lokukhusela iimveliso zepropathi enomgangatho ophezulu wokuqonda. Senze uhlalutyo olupheleleyo lwamalungelo epropathi enomgangatho ophezulu wokuqonda kwiimveliso zethu, kwaye kwangaxeshanye senze uyilo lokhuseleko lwepropathi enomgangatho ophezulu wokuqonda kwiimveliso zethu kunye nobuchwepheshe.
