Enye dzidzɔ na mí be míaɖe gbeƒãe be ʋu ƒe sisi ƒe ŋkuléleɖenuŋu ƒe kpɔɖeŋu yeye siwo le Joytech Healthcare ƒe atike siwo li fifia me xɔ FDA 510(k) ƒe mɔɖeɖe dzidzedzetɔe , si do alɔ woƒe dzadzraɖo ɖe United States ƒe atikewɔnuwo ƒe asi ŋu.
Mɔɖeɖea ɖo kpe edzi be mɔ̃awo ɖo United States ƒe sededewo ƒe nudidiwo gbɔ le dedienɔnɔ kple dɔwɔwɔ ŋu abe atikewɔmɔ̃ siwo ƒe hatsotso II ene , eye wosɔ kple mɔ̃ siwo wozãna tsɔ gblɔa nya siwo wodzrana le se nu la ŋutɔ.
Ʋu ƒe Ʋuʋudedi Dzi Kpɔkpɔ ƒe Kpɔɖeŋu Yeye Siwo Wokɔ
Kpɔɖeŋu yeye siwo ŋu woɖe asi le la nye abɔta ƒe ʋu ƒe sisi le wo ɖokui si ƒe mɔ̃ siwo wowɔ na ame tsitsi siwo zãnɛ le aƒeme kple atikewɔƒe siaa.
This models are part of Joytech Healthcare’s established blood pressure monitor product line , eye woto ɖoɖo yeyewo kple dzidzedze mɔ̃ɖaŋununya vɛ be woado alɔ ezãla ƒe nuteƒekpɔkpɔ si nyo wu kple dzidzedze ƒe kakaɖedzi.
Wozãa mɔ̃ɖaŋununya si wotsɔ dzidzea ʋu ƒe sisi si wotu ɖe ʋu ƒe sisi dzi , si wɔnɛ be woate ŋu adzidze ʋu ƒe sisi le abɔta ƒe yaƒoƒoɣi. Esia kpena ɖe ame ŋu be dzidzenu ƒe dɔwɔwɔ nyuie kple ezãla ƒe akɔfafa nyona ɖe edzi , esime wòléa nuxexlẽ siwo li ke eye kakaɖedzi le wo ŋu me ɖe asi.
Dɔwɔwɔ Deŋgɔwo Dzi Kpɔkpɔ Na Aƒeme Kple Dɔnɔdzikpɔƒe Zazã
Le alesi woɖoe nu la, dɔwɔnuawo ate ŋu awɔ dɔ siwo gbɔna:
Cuff Tightness Indicator , si doa alɔ cuff zazã nyuie hafi woadzidzee
Excessive Movement Indicator , si kpena ɖe ame ŋu be dzidzenua nali ke to ʋuʋu kpɔkpɔ le ezãɣi me
AFIB (Atrial Fibrillation) detection function , si doa alɔ dzi ƒe tsotso dodokpɔ si mesɔ o le dzidzedze me
MVM function , si naa nuxexlẽ geɖe ƒe mamã dedie si wowɔna le wo ɖokui si hena ɖekawɔwɔ si nyo wu
Wotrɔ asi le dɔ siawo ŋu be woado alɔ ʋu ƒe sisi dzi kpɔkpɔ si ŋu kakaɖedzi le le aƒeme lãmesẽnyawo gbɔ kpɔkpɔ kple dɔdaƒewo ƒe dodokpɔ siaa me.
Cuff Size ƒe Ðoɖowɔɖi Geɖewo
Cuff ƒe lolome ƒe ɖoɖo vovovowo li, siwo dometɔ aɖewoe nye 22–36 cm, 22–42 cm, kple 32–48 cm , si wowɔ be wòaxɔ ame tsitsiwo ƒe alɔ ƒe gotagome vovovowo eye woakpɔ egbɔ be wodzidze wo pɛpɛpɛ le ezãlawo ƒe hatsotso vovovowo me.
Adzɔnuwo ƒe Nya Veviwo
FDA 510(k) kɔ ʋu ƒe sisi ƒe mɔ̃ yeye siwo le ʋu ƒe sisi dzi kpɔkpɔ ƒe mɔ̃ si li fifia me
Abɔta ƒe ʋu ƒe sisi dzi kpɔkpɔ ƒe ɖoɖo si wowɔna le eɖokui si
Mɔ̃ɖaŋununya si wotu ɖe ga ƒe asixɔxɔ dzi dzidzea nu hena akɔfafa kple dɔwɔwɔ nyuie wu
Cuff Tightness Indicator si woate ŋu atia hena cuff ƒe ɖoɖo nyuitɔ
Ʋuʋu si gbɔ eme ƒe Dzesi si woate ŋu atia hena ʋuʋu deteksi le dzidzedze me
AFIB deteksi dɔwɔwɔ na dzi ƒe tsotso dodokpɔ ƒe kpekpeɖeŋu si mesɔ o
MVM dɔwɔwɔ na dzidzedze ƒe ɖekawɔwɔ kple gbugbɔgawɔ si nyo wu
Cuff ƒe lolome ƒe ɖoɖo geɖewo na ame tsitsiwo zãlawo
Esɔ na aƒeme zazã kple dɔdaƒewo ƒe dodokpɔ ƒe nɔnɔmewo
Sedziwɔwɔ kple Asitsatsa ƒe Dzadzraɖo
FDA 510(k) ƒe mɔɖeɖe ɖe Joytech Healthcare ƒe ɖokuitsɔtsɔna be yeawɔ ɖe sewo dzi kple adzɔnuwo ƒe nyonyome na xexeame katã ƒe lãmesẽnyawo gbɔ kpɔkpɔ ƒe asiwo, siwo dome United States hã le, fia.
510(k) xexlẽdzesi siwo sɔ la le dutoƒo eye woate ŋu aɖo kpe wo dzi le FDA ƒe nyatakakadzraɖoƒea , si ana woakpɔ egbɔ be wowɔa nu le gaglãgbe eye woate ŋu akpɔ wo yome.
Habɔbɔ ƒe Mɔnukpɔkpɔwo na Mamãlawo kple OEM/ODM Asitsalawo
ate ŋu ada wo kpɔ. Atikewɔnuwo mamalawo, nusiwo wotsɔ tso duta vɛ, kple OEM/ODM dɔwɔhati siwo le ʋu ƒe sisi dzi kpɔkpɔ ƒe kuxiwo gbɔ kpɔnu siwo sɔ ɖe se nu dim na woƒe asiwo
Míexɔa nuwɔwɔ aduadu kple hadɔwɔla siwo tsɔ ɖe le adzɔnuwo me toto, ame ŋutɔ ƒe ŋkɔwo ƒe ŋgɔyiyi, kple asi ƒe dɔwɔwɔ ƒe kpekpeɖeŋu na xexeame katã ƒe mama me.
Ku ɖe Joytech Lãmesẽnyawo Gbɔkpɔha ŋu
Joytech Lãmesẽnyawo Gbɔkpɔha nye aƒeme lãmesẽnyawo gbɔ kpɔkpɔ kple atikewɔwɔ me ŋkuléleɖenuŋumɔ̃wo wɔla bibi, si bi ɖe ʋu ƒe sisidzidzenuwo, dzoxɔxɔdzidzenuwo, ʋu ƒe sisidzidzenuwo, nebulizers, no me pɔmpiwo kple lãmesẽnyawo gbɔ kpɔkpɔ ƒe atike bubuwo me.
Míewɔa ɖoɖo OEM / ODM atikewɔnuwo gbɔkpɔnuwo na xexeame katã ƒe lãmesẽnyawo gbɔ kpɔkpɔ ƒe adzɔhawo, mamalawo, kple hadɔwɔlawo, eye míeléa fɔ ɖe sewo dzi wɔwɔ, adzɔnuwo ƒe kakaɖedzi, kple nuwɔwɔ aduadu ɣeyiɣi didi ŋu.
Te Ðe Mía Ŋu
Ne èdi adzɔnuwo me dzodzro ƒe kpɔɖeŋuwo, mɔ̃ɖaŋu ŋuti nuŋlɔɖiwo, alo nuwɔwɔ aduadu ku ɖe míaƒe... FDA 510(k) kɔ ʋu ƒe sisi ƒe ŋkuléleɖenuŋu ƒe kpɔɖeŋuwo ŋu, taflatse te ɖe míaƒe ƒuƒoƒoa ŋu.
