I-PMcardio iyisixazululo sezokwelapha esinamandla e-AI esinikeza ochwepheshe bezokunakekelwa kwempilo amandla okutolika ama-ECG ngokunembile ngemizuzwana futhi bahlonze futhi belaphe izifo zenhliziyo ezingama-39 ngokuzethemba kukadokotela wenhliziyo ochwepheshe. I-PMcardio iyisisetshenziswa sezokwelapha se-Class IIb esigunyazwe ngaphansi komthethonqubo we-EU MDR. Uhlelo lokusebenza luhlanganisa ubuchwepheshe bomuntu nobuchwepheshe be-AI obusezingeni eliphezulu.
I-PMcardio inikeza izincomo zokuphathwa kwesiguli kanye nokwelashwa okusekelwe kumhlahlandlela wokusebenza komtholampilo. Isebenzisa uhlelo olujwayelekile lokunquma ukukhanya kwethrafikhi, i-PMcardio ivumela abasebenzisi ukuthi bahlole iziguli ngokunembe kakhudlwana.
Ukusebenza komtholampilo kwe-PMcardio kuye kwalinganiswa ngokumelene nodokotela abajwayelekile kanye nodokotela benhliziyo. I-PMcardio ibonise ukusebenza okuthuthukisiwe kokuxilonga kuwo wonke ama-metrics okuhlola ajwayelekile.
Izici ezibalulekile:
• I-ECG Digitisation: I-PMcardio iguqula noma iliphi ifomu lephepha noma isithombe esisekelwe esikrinini se-ECG sibe igagasi ledijithali elimisiwe.
• Ukutolikwa kwe-ECG: I-PMcardio ifunda noma iyiphi i-ECG eholayo engu-12 futhi iyixilonga ngokutholwa okuthuthukisiwe okumaphakathi okungu-38.8%.
• Izincomo zokwelapha: I-PMcardio isiza ukuhlola nokuphatha iziguli kangcono ngenxa yesistimu yokunquma ukukhanya kwethrafikhi kanye nezincomo zokwelashwa ezilandela umhlahlandlela.
• Ukubika kwe-ECG yokuxilonga: I-PMcardio inikeza umbiko ogcwele, ochwepheshe wokuxilonga we-ECG ongathunyelwa futhi ulondolozwe kungobo yomlando yedijithali.
UMUZI wokuzihlangula:
I-PMcardio imakwe nge-CE, Idivayisi Yezokwelapha Yesigaba IIb ngaphansi kwemithetho ye-EU. Umkhiqizo uhloselwe ukusetshenziswa ochwepheshe bezempilo abaqeqeshiwe ukuze kuhlolwe izifo zenhliziyo nemithambo yegazi besebenzisa idatha ye-ECG. Isicelo sinikeza izincomo zokuxilonga nokwelashwa kweziguli ezineminyaka engu-18 nangaphezulu.
Imiyalo ye-elekthronikhi yokusetshenziswa ingafinyelelwa esigabeni esingaphakathi kohlelo lokusebenza ngemuva kokungena noma ukusebenzisa isixhumanisi esisezansi kwesizindalwazi sethu. Uma uyikhasimende elibhalisiwe, ungacela inguqulo ephrintiwe yemiyalelo ozoyisebenzisa ngokuxhumana nosekelo lwethu. Ngemva kokuqinisekisa ukufaneleka kwakho, inguqulo ephrintiwe yemiyalelo yokusebenzisa izothunyelwa futhi ilethwe phakathi kwezinsuku eziyisikhombisa ngaphandle kwezindleko ezengeziwe.
I-UDI-DI eyisisekelo: 426073843PMcardio0001H2
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