Iimboniselo: 0 uMbhali: Ixesha lokupapasha loMhleli weSiza: 2026-05-05 Imvelaphi: Isiza
Siyavuya ukwazisa ukuba iimodeli ezintsha zokujonga uxinzelelo lwegazi ngaphakathi komgca wemveliso okhoyo weJoytech Healthcare ufumene ngempumelelo imvume ye-FDA 510(k) , exhasa ukulungela kwabo imakethi yezixhobo zonyango zase-United States.
Ukukhutshwa kuqinisekisa ukuba izixhobo zihlangabezana neemfuno zokulawula zase-US zokhuseleko kunye nokusebenza njengezixhobo zonyango lwe-Class II , kwaye zilingana kakhulu nezixhobo ezithengiswayo ngokusemthethweni.
Iimodeli ezisandula ukucocwa zizijongi zoxinzelelo lwegazi ezizenzekelayo ezilungiselelwe abasebenzisi abadala ngokubanzi kuzo zombini iimeko zasekhaya kunye nekliniki.
Le mizekelo iyingxenye ye-Joytech Healthcare esekelwe kumgca wemveliso yoxinzelelo lwegazi , kwaye yazisa ulungelelwaniso oluhlaziyiweyo kunye nobuchwepheshe bokulinganisa ukuxhasa amava omsebenzisi aphuculweyo kunye nokuthembeka kokulinganisa.
Basebenzisa itekhnoloji yokulinganisa uxinzelelo lwegazi esekelwe ekunyukeni kwamaxabiso , evumela umlinganiselo ngexesha lokunyuka kwamaxabiso e-cuff. Oku kunceda ukuphucula ukusebenza komlinganiselo kunye nokuthuthuzela komsebenzisi , ngelixa ugcina ukufundwa okuzinzile nokuthembekileyo.
Ngokuxhomekeke kubumbeko, izixhobo zinokubandakanya le misebenzi ilandelayo:
I-Cuff Tightness Indicator , exhasa isicelo esifanelekileyo se-cuff ngaphambi kokulinganisa
Isalathisi sokuhamba ngokugqithisileyo , ukunceda ukuphucula ukuzinza kokulinganisa ngokufumanisa ukunyakaza ngexesha lokusetyenziswa
I-AFIB (i-Atrial Fibrillation) umsebenzi wokufumanisa , ukuxhasa ukuhlolwa kwentliziyo engaqhelekanga ngexesha lokulinganisa
Umsebenzi we-MVM , ukubonelela nge-avareji ezenzekelayo yofundo oluninzi ukwenzela ukuhambelana okuphuculweyo
Le misebenzi yenzelwe ukuxhasa iliso elithembekileyo loxinzelelo lwegazi kuzo zombini ukhathalelo lwezempilo lwasekhaya kunye neemeko zovavanyo lweklinikhi..
Ulungelelwaniso lwesayizi yecuff ezininzi luyafumaneka, kubandakanywa i-22-36 cm, 22-42 cm, kunye ne-32-48 cm , eyilelwe ukujongana neesangqa zengalo zabantu abadala ezahlukeneyo kunye nokuqinisekisa umlinganiselo ochanekileyo kumaqela ahlukeneyo abasebenzisi.
I-FDA 510(k) icoce imifuziselo emitsha kumgca okhoyo wokubeka iliso woxinzelelo lwegazi
Upper-arm oluzenzekelayo inkqubo esweni uxinzelelo lwegazi
Itekhnoloji yokulinganisa i-inflation esekelwe ekuphuculeni induduzo kunye nokusebenza kakuhle
Isalathisi sokuQiniswa kweCuff esiKhethekileyo sokubekwa ngokufanelekileyo kwe-cuff
Isalathisi sokuhamba ngokuKhethekileyo esiKhethekileyo sokubonwa kwentshukumo ngexesha lokulinganisa
Umsebenzi wokubona i-AFIB yokuxhasa ukubetha kwentliziyo engaqhelekanga
Umsebenzi we-MVM wokuphucula ukuhambelana komlinganiselo kunye nokuphindaphinda
Ulungelelwaniso lwesayizi yecuff ezininzi kubasebenzisi abadala
Ilungele ukusetyenziswa kwekhaya kunye neemeko zovavanyo lweklinikhi
Ukukhutshwa kwe-FDA 510 (k) kubonisa ukuzibophelela kweJoytech Healthcare ekuthotyelweni kokulawula kunye nomgangatho wemveliso kwiimarike zezempilo zehlabathi, kuquka ne-United States.
Amanani angama-510(k) ahambelanayo afumaneka esidlangalaleni kwaye ayaqinisekiswa kwisiseko sedatha se-FDA , ukuqinisekisa ukungafihli kunye nokulandeleka.
Ezi modeli zisanda kususwa ziyafumaneka ukuze zihlolwe ngabasasazi bezixhobo zonyango, abarhwebi, kunye namaqabane e-OEM/ODM afuna izisombululo ezithobelayo zokuhlola uxinzelelo lwegazi kwiimarike zabo.
Siyayamkela intsebenziswano namahlakani anomdla ekuvavanyeni imveliso, uphuhliso lweeleyibhile zabucala, kunye nenkxaso yokusasazwa kweemarike zokusasazwa kwehlabathi.
Joytech Healthcare ngumvelisi oqeqeshiweyo wokhathalelo lwezempilo lwasekhaya kunye nezixhobo zokubeka iliso zonyango, okhethekileyo kwiimonitha zoxinzelelo lwegazi, i-thermometers, i-pulse oximeters, i-nebulizers, iimpompo zamabele kunye nezinye iimveliso zempilo.
Sibonelela OEM/ODM izisombululo isixhobo zonyango ngeempawu zokhathalelo lwempilo zehlabathi, abasasazi, kunye namaqabane, sigxile ekuthotyelweni kolawulo, ukuthembeka kwemveliso, kunye nentsebenziswano yexesha elide.
Ngeesampuli zovavanyo lwemveliso, amaxwebhu obugcisa, okanye intsebenziswano malunga neyethu I-FDA 510(k) icociwe iimodeli zokujonga uxinzelelo lwegazi , nceda uqhagamshelane neqela lethu.