Ubuchwepheshe obugqokekayo be-CIRCUL™ pulse oximetry bunokuhlobana okubalulekile ngokwezibalo ekuhlinzekeni amanani azinzile okugcwalisa komoyampilo kubantu abanemibala emnyama.
I-PR Newswire-PR Newswire / Manhattan Beach, California, February 23, 2021, BodiMetrics, umholi womhlaba kubuchwepheshe benzwa yeringi yezokwelapha, namuhla umemezele imiphumela yocwaningo lomtholampilo oluqinisekisa i-CIRCUL™ ring pulse oximeter yayo Ukusebenza nokuthembeka kwabahlanganyeli be-pigmentation ebumnyameni, iyibeka njengethuluzi eliqhubekayo lokuqapha umoya wegazi wezinhlanga ezincane e-United States nasemhlabeni.Isihloko sakamuva esanyatheliswa kuyi-New England Journal of Medicine yabonisa ukuthi iziguli ezimnyama zisengozini enkulu ngenxa ye-hypoxemia kanye nemiphumela emibi yezempilo elandelayo.Muva nje, othile uhlole ukwethembeka kwama-pulse oximeters., Lena idivayisi engahlaseli yokuhlola izinga lokushaya kwenhliziyo ne-hemoglobin egcwele umoya-mpilo.Uma kuqhathaniswa neziguli ezimhlophe, ukunemba kokulinganisa kwe-pulse oximeter kubi.
Ucwaningo lokuqinisekisa umtholampilo lwe-CIRCUL™Ring olwenziwa esibhedlela sase-Tongde esifundazweni sase-Zhejiang, e-China luqhathanise imiphumela yokulinganisa ngesikhathi esisodwa ye-CIRCUL™Ring kanye nokuhlolwa kwe-arterial blood gas (ABG) kwabantu abangu-12 (abansundu abangu-4, cishe u-33% wabo bonke ababhalisiwe).Umphumela wokuhlolwa kwe-ABG uthathwa njengendlela enembe kakhulu yokukala izinga le-oxygenation egazini, kodwa uhlasela kakhulu ngenxa yesidingo sokuthatha amasampula egazi le-venous.Kwabamnyama, imiphumela yezilinganiso zokugcwala komoyampilo eziyi-100 ezithathwe eringini ye-CIRCUL™ zinokuhlobana okuhle kakhulu nedatha etholwe ngesikhathi esifanayo nokuhlolwa kwe-ABG (ububanzi bokugcwalisa komoyampilo bungu-100% ukuya ku-70%).Umehluko omaphakathi phakathi kwamanani e-CIRCUL™ kanye ne-ABG ngu-1.06% kuphela.
Ubhubhane oluqhubekayo lwe-COVID lugqamisa ukubaluleka kokuqapha i- blood oxygenation yomuntu siqu (SpO2) ngaphambi, ngesikhathi nangemuva kokuchayeka noma ukutheleleka.NgoJanuwari 25, 2021, uSenator Elizabeth Warren (Elizabeth Warren (D-Mass.), Cory Booker (DN.J.) kanye noRon Wyden) (D-Ore.) Lokhu kwagcizelelwa encwadini eya ku-US Food and Drug Administration. (FDA).Ukubuyekezwa kokunemba kwe-pulse oximeter yeziguli kanye nabathengi bezinhlanga ezahlukene.Incwadi yayicaphuna izinto ezimbalwa.Ucwaningo luye lwabonisa ukuthi ukunemba kwama-pulse oximeters ezigulini ezimnyama kuphansi kuneziguli ezimhlophe, okungenzeka kube umphumela wokuchema kobuhlanga ekulinganisweni kwedivayisi.Olunye ucwaningo olunjalo lwathola ukuthi amazinga aphansi e-oxygenation yegazi iziguli eziMnyama zinamathuba aphindwe kathathu okuba zingabonwa.Ababhali balolu cwaningo baphinde bafingqa abakutholile “kuqokomisa isidingo esiqhubekayo sokuqonda nokulungisa ukucwasa kwezinhlanga ku-pulse oximetry nezinye izinhlobo zobuchwepheshe bezokwelapha.”
Incwadi yokwengamela eya ku-FDA ngoJanuwari 25, 2021, "AmaSenator Warren, Booker, kanye noWyden banxusa i-FDA ukuthi ibhekane nokukhathazeka ngamaphutha ayingozi we-pulse oximeter ezigulini ezinemibala", https://www.warren.senate.gov/oversight/ izincwadi/ Izigele uWarren Booker noWooden banxuse i-FDA ukuthi ibhekane nenkinga yama-pulse oximeters angalungile ezigulini ezinemibala eyingozi.
I-BodiMetrics izibophezele ekuthuthukiseni nasekunikezeni imishini emisha, efana nezindandatho ze-CIRCUL, izinhlelo zokusebenza kanye ne-algorithms, engahlinzeka ngemisebenzi yokuxilongwa nokuqapha okukude ukuze kwandiswe ububanzi bokunakekelwa, ukukhuthaza impilo eqhubekayo kanye nokwenza ngcono ukuzilawula kanye nezinqubo zokunakekelwa kokusiza ezivela eceleni. nemithi yokwelapha efana nokuhluleka kwenhliziyo eqinile (CHF), isifuba somoya, i-COPD, i-apnea yokulala, nempilo yomndeni.
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Isikhathi sokuthumela: Mar-11-2021