Izibane zoMbane, i-Defibrillators, kunye neSekethe yoKhuselo igcina ubomi |Ecg Leadwires

Ingxelo inikezela ngecandelo elineenkcukacha zeSixhobo sezoNyango, esineSensor esahlukileyo, enye, iNdlela yeMarike ngeSicelo seNgozi kunye neSebe likaNgxamiseko, iYunithi yokuNakekelwa okunzulu, iiWadi Jikelele, ukhathalelo lwasekhaya, Enye yemarike yehlabathi esekwe kubuchwephesha, uhlobo lwemveliso, isicelo, kunye iinkqubo ezahlukeneyo kunye neenkqubo.Le ngxelo ibonelela ngovavanyo olucokisekileyo lwezinto zokuqhuba i-Handheld Pulse Oximetry market, ezivunywa ngokusekelwe kwiimfuno zabasebenzisi bokugqibela, utshintsho oluguquguqukayo kwimarike, izinto zokuthintela, kunye nesivumelwano solawulo.

Ngaba iimveliso ze-Apple zingakusindisa kwi-stroke, isiqendu se-cardio okanye ukuwa okulimazayo?I-Apple ilumkile malunga nokwenza amabango anjalo ngqo.

I-CardioComm Solutions 'i-teknoloji ye-patent kunye ne-proprietary isetyenziswa kwiimveliso zokurekhoda, ukujonga, ukuhlalutya nokugcina i-electrocardiograms yokuxilongwa kunye nokulawulwa kwezigulane zentliziyo.Iimveliso zithengiswa kwihlabathi jikelele ngokudityaniswa kwenethiwekhi yokusasazwa kwangaphandle kunye neqela lokuthengisa elisekelwe eMntla Melika.I-CardioComm Solutions ifumene i-ISO 13485: isatifikethi se-2016, i-HIPAA iyahambelana kwaye ibambe iimvume ezivela kwi-European Union (CE Mark), i-USA (FDA) kunye neCanada (i-Health Canada).

I-HSP 2.0 iphinde idibaniswe kwi-microcontroller yezinto ezinxitywayo kunye nezicelo ze-IoT, i-biometric sensor hub ene-algorithm ye-heart-rate embedded, i-optical pulse oximeter kunye nokunye.

Ngaba iteknoloji enthusiast, oye waqokelela uluhlu olubanzi lwamava kushishino esemncinane kakhulu.Imvelaphi yakhe ebanzi yesoftware yekhompyuter kunye nenkqubo kunye nokuqhelaniswa nokuphuculwa kwetekhnoloji yamva nje kunye nokuqaliswa, kumnceda ukuba azise ezona ndaba zobugcisa zinika umdla kunye nezihamba phambili.Qhagamshelana noMbhali

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Okukhona sitsala imisonto, kokukhona sibona ukuba sinethuba elikhulu lokunceda abantu ngokwezempilo,” utshilo uWilliams kudliwanondlebe.

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Abavelisi balandelayo bagutyungelwe kule ngxelo, kunye neentengiso, ingeniso, isabelo semarike kwinkampani nganye: Covidien CareFusion GE Healthcare Koninklijke Philips Masimo CAS Medical Systems Opto Circuits Nonin Medical Smiths Medical Welch Allyn Spacelabs Healthcare Zensorium Meditech Equipment Nihon Kohden

Ngaphaya koko, ingxelo iyavuma ukuba kwezi meko zikhulayo kunye nokuphucula ngokukhawuleza, ezona nkcukacha zentengiso kunye neenkcukacha zentengiso zibaluleke kakhulu ukumisela intsebenzo ngexesha loqikelelo kunye nokwenza ukhetho olubalulekileyo lwenzuzo kunye nokukhula kweMakethi yePulse Oximeter.Ukongeza, ingxelo ibandakanya uluhlu lwezinto ezichaphazela ukukhula kweMakethi ye-Oximeter yePulse kwixesha lengqikelelo.Ngaphaya koko, olu hlahlelo lukhethekileyo lukwamisela impembelelo kumacandelo ngamanye emarike.

Isiqwenga esincinci, esingenazingcingo esiphuhliswe yi-EPFL spin-off Smartcardia inokulinganisa iimpawu ezibalulekileyo zezigulane zegumbi likaxakeka ngokuthembeka okufanayo kunye neenkqubo ezikhoyo ezibandakanya iintambo ezinzima.Emva kovavanyo olubanzi kwizibhedlele ezininzi, isixhobo kutshanje sifumene uphawu lwe-CE ye-European Union kwizixhobo zonyango kwaye siya kusungulwa kwintengiso kwiintsuku ezizayo.

Isicelo se-510 (k) siqalise uPhononongo lwe-Substantive yeentsuku ze-90 yi-FDA ngoJuni 8, 2018. I-FDA icele ulwazi olongezelelweyo kwiNkampani malunga nesixhobo sikaJulayi 27, 2018, esimisa iwashi kwi-Substantive Review time line.Ukubalwa kweentsuku ezingama-90 kuya kuqalisa kwakhona xa i-FDA yamkele impendulo yeNkampani kulwazi olongezelelweyo oluceliweyo.