Siyajabula ukumemezela ukuthi amamodeli amasha okuqapha umfutho wegazi ngaphakathi komugqa womkhiqizo okhona we-Joytech Healthcare athole ngempumelelo imvume ye-FDA 510(k) , esekela ukulungela kwawo imakethe yemishini yezokwelapha yase-United States.
Ukugunyazwa kuqinisekisa ukuthi amadivayisi ahlangabezana nezimfuneko zokulawula zase-US zokuphepha nokusebenza njengamadivayisi ezokwelapha Ekilasi II , futhi alingana kakhulu namadivayisi ayisilandisi athengiswa ngokusemthethweni.
Amamodeli Okuhlola Umfutho Wegazi Asanda Kusulwa
Amamodeli asanda kusulwa amangqamuzana omfutho wegazi angaphezulu kwengalo aklanyelwe abasebenzisi abadala abavamile kuzo zombili izimo zasekhaya nezomtholampilo.
Lawa mamodeli ayingxenye yomugqa womkhiqizo osungulwe we-Joytech Healthcare wokuqapha umfutho wegazi , futhi wethula ukulungiselelwa okubuyekeziwe nobuchwepheshe bokulinganisa ukuze kusekelwe ukuzizwisa okuthuthukisiwe komsebenzisi nokuthembeka kwesilinganiso.
Basebenzisa ubuchwepheshe bokulinganisa umfutho wegazi obusekelwe ekwenyukeni kwamandla emali , obuvumela ukukala ngesikhathi sokwehla kwamandla emali. Lokhu kusiza ukuthuthukisa ukusebenza kahle kokulinganisa nokunethezeka komsebenzisi , kuyilapho kugcinwa ukufundwa okuzinzile nokuthembekile.
Imisebenzi Yokuqapha Okuthuthukisiwe Yokusetshenziswa Kwekhaya Nokwelashwa
Ngokuya ngokucushwa, amadivayisi angafaka phakathi imisebenzi elandelayo:
Inkomba Ye-Cuff Tightness , esekela isicelo esifanele se-cuff ngaphambi kokulinganisa
Inkomba Yokunyakaza Okudlulele , isiza ukuthuthukisa ukuqina kokulinganisa ngokuthola ukunyakaza phakathi nokusetshenziswa
Umsebenzi wokutholwa kwe-AFIB (Atrial Fibrillation) , osekela ukuhlolwa kokushaya kwenhliziyo okungajwayelekile ngesikhathi sokulinganisa
Umsebenzi we-MVM , ohlinzeka ngesilinganiso esizenzakalelayo sokufundwa okuningi ukuze kube nokuvumelana okuthuthukisiwe
Le misebenzi yakhelwe ukusekela ukuqapha okuthembekile komfutho wegazi kukho kokubili ukunakekelwa kwezempilo kwasekhaya kanye nezimo zokuhlolwa komtholampilo..
Ukucushwa kosayizi we-Cuff amaningi
Ukucushwa kosayizi we-cuff abaningi kuyatholakala, okufaka phakathi u-22–36 cm, 22–42 cm, kanye no-32–48 cm , okudizayinelwe ukuthwala isiyingi sezingalo sabadala esihlukile nokuqinisekisa ukukalwa okunembile kuwo wonke amaqembu abasebenzisi abahlukahlukene.
Amaphuzu Avelele Womkhiqizo
I-FDA 510(k) isule amamodeli amasha ngaphakathi komugqa okhona wokuqapha umfutho wegazi
Isistimu yokuqapha umfutho wegazi engaphezulu kwengalo
Ubuchwepheshe bokulinganisa obusekelwe ekwenyukeni kwamandla emali ukuze kuthuthukiswe ukunethezeka nokusebenza kahle
Isikhombi Sokuqina Kwe-Cuff Ongakukhetha sokuma kwekhafu ngendlela efanele
Isikhombi Sokunyakaza Okudlulele Ongakukhetha sokutholwa kokunyakaza ngesikhathi sokulinganisa
Umsebenzi wokuthola i-AFIB wosekelo lokuhlola ukushaya kwenhliziyo okungajwayelekile
Umsebenzi we-MVM wokuvumelana kokulinganisa okuthuthukisiwe nokuphindaphinda
Ukulungiselelwa kukasayizi we-cuff okuningi kubasebenzisi abadala
Ifanele ukusetshenziswa kwasekhaya kanye nezimo zokuhlolwa komtholampilo
Ukuthobela Umthetho kanye Nokulungela Izimakethe
Ukugunyazwa kwe-FDA 510(k) kubonisa ukuzibophezela kweJoytech Healthcare ekuthobeleni imithetho nekhwalithi yomkhiqizo ezimakethe zokunakekelwa kwezempilo zomhlaba wonke, okuhlanganisa ne-United States.
Izinombolo ezihambisanayo ezingu-510(k) zitholakala esidlangalaleni futhi ziyaqinisekiswa kusizindalwazi se-FDA , ukuqinisekisa ukubonisa ngale nokulandeleka.
Amathuba Wokubambisana Wabasabalalisi kanye Namakhasimende e-OEM/ODM
Lawa mamodeli asanda kusulwa ayatholakala ukuze ahlolwe abasabalalisi bemishini yezokwelapha, abangenisi, nozakwethu be-OEM/ODM abafuna izixazululo ezithobelanayo zokuqapha umfutho wegazi ezimakethe zabo.
Siyakwamukela ukubambisana nozakwethu abanentshisekelo ekuhlolweni komkhiqizo, ekuthuthukisweni kwamalebula ayimfihlo, nokwesekwa kokuthunyelwa kwezimakethe ukuze kusatshalaliswe umhlaba wonke.
Mayelana neJoytech Healthcare
Joytech Healthcare ungumkhiqizi ochwepheshile wokunakekelwa kwempilo yasekhaya kanye namadivayisi okuqapha ezempilo, osebenza ngeziqapha umfutho wegazi, ama-thermometers, ama-pulse oximeters, ama-nebulizers, amaphampu webele neminye imikhiqizo yokunakekelwa kwezempilo.
Sihlinzeka Izixazululo zedivayisi yezokwelapha ye-OEM/ODM ngamabhrendi okunakekelwa kwezempilo emhlabeni wonke, abasabalalisi, nozakwethu, sigxile ekuthobeleni imithetho, ukwethembeka komkhiqizo, nokubambisana kwesikhathi eside.
Ukuze uthole amasampula okuhlolwa komkhiqizo, imibhalo yezobuchwepheshe, noma ukubambisana maqondana nezethu I-FDA 510(k) esule amamodeli okuqapha umfutho wegazi , sicela uxhumane nethimba lethu.
