Yɛn ani gye sɛ yɛbɛbɔ amanneɛ sɛ mogya mmoroso a wɔde hwɛ nneɛma foforo a ɛwɔ Joytech Healthcare nneɛma a ɛwɔ hɔ dedaw no mu no atumi anya FDA 510(k) clearance , a ɛfoa wɔn ahoboa a wɔayɛ ama United States nnuruyɛ mfiri gua so.
The clearance si so dua sɛ mfiri ahorow no du U.S. mmara ahwehwɛde ahorow a ɛfa ahobammɔ ne adwumayɛ ho sɛ Class II aduruyɛ mfiri , na ɛne predicate mfiri a wɔtɔn wɔ mmara kwan so no yɛ pɛ kɛse.
Mogya Nhyɛso a Wɔde Hwɛ Abasa a Ɛwɔ Atifi So a Wɔaprapra Mu Foforo
Mfonini ahorow a wɔayi afi hɔ foforo no yɛ mfiri a wɔde hwɛ mogya mmoroso a ɛnyɛ adwuma wɔ nsa atifi a wɔayɛ ama mpanyimfo a wɔde di dwuma nyinaa wɔ fie ne ayaresabea nyinaa.
Saa nhwɛsoɔ yi yɛ Joytech Healthcare’s established blood pressure monitor product line , na ɛde nhyehyeɛ foforɔ ne susuw mfiridwuma ba de boa osuahu a ɛkɔ anim a ɔde di dwuma ne susudua ahotosoɔ.
Wɔde mfiri bi a egyina mogya mmoroso a ɛkɔ soro so susuw mogya mmoroso di dwuma , na ɛma wotumi susuw bere a cuff inflation rema no. Eyi boa ma susuw a ɛkɔ so yiye ne nea ɔde di dwuma no ahotɔ tu mpɔn , bere a ɛma akenkan a ɛyɛ den na wotumi de ho to so no kɔ so.
Advanced Monitoring Functions a Wɔde Di Dwuma wɔ Ofie ne Ayaresabea
Ɛdenam nhyehyɛe so no, ebia nneɛma a edidi so yi bɛka mfiri ahorow no ho:
Cuff Tightness Indicator , a ɛboa ma wɔde cuff di dwuma yiye ansa na wɔasusuw
Excessive Movement Indicator , a ɛboa ma susuw no gyina pintinn denam kankyee a wohu bere a wode redi dwuma no so
AFIB (Atrial Fibrillation) detection function , a ɛboa koma bɔ ho nhwehwɛmu a ɛnkɔ so daa bere a wɔresusuw no
MVM function , a ɛma automatic averaging of multiple akenkan ma nkɔso a ɛkɔ so pɛpɛɛpɛ
Wɔayɛ saa dwumadi ahorow yi sɛnea ɛbɛyɛ a ɛbɛboa mogya mmoroso a wotumi de ho to so a wɔhwɛ so wɔ ofie akwahosan ne ayaresabea nhwehwɛmu tebea horow nyinaa mu.
Cuff Size Nsiesiei ahorow pii
Cuff size nhyehyeɛ ahodoɔ pii wɔ hɔ, a 22–36 cm, 22–42 cm, ne 32–48 cm ka ho , a wɔayɛ sɛ ɛbɛfa mpaninfoɔ nsa ntwemu ahodoɔ na wɔahwɛ sɛ wɔbɛsusu pɛpɛɛpɛ wɔ dwumadie akuo ahodoɔ mu.
Nneɛma Titiriw a Wɔde Yɛ Nneɛma
FDA 510(k) yii mfonini foforo fii mogya mmoroso a wɔhwɛ so dedaw no mu
Abasa atifi afiri a wɔde hwɛ mogya mmoroso a ɛnyɛ adwuma
Mfiridwuma a wɔde susuw nneɛma bo a ɛkɔ soro ma ahotɔ ne adwumayɛ a ɛkɔ anim
Optional Cuff Tightness Indicator ma cuff gyinabea yiye
Optional Excessive Movement Indicator a wɔde hu kankyee bere a wɔresusuw no
AFIB detection function ma koma bɔ a ɛnyɛ daa nhwehwɛmu mmoa
MVM dwumadie ma susudua a ɛkɔ so pɛpɛɛpɛ ne nea wɔsan yɛ no tu mpɔn
Cuff size nhyehyɛe ahorow pii ma mpanyimfo a wɔde di dwuma
Ɛfata ma ofie a wɔde di dwuma ne ayaresabea nhwehwɛmu tebea horow
Mmara a Wɔdi So ne Guadidan mu Ahosiesie
FDA 510(k) tumi krataa no kyerɛ sɛ Joytech Healthcare ahyɛ bɔ sɛ wobedi mmara so na wɔayɛ nneɛma no yiye ama wiase nyinaa akwahosan ho gua ahorow, a United States ka ho.
510(k) nɔma a ɛne no hyia no wɔ baguam na wotumi di ho adanse wɔ FDA database no mu , na ɛhwɛ hu sɛ ɛda adi pefee na wotumi di akyi.
Ayɔnkofa Hokwan ahorow ma Wɔn a Wɔkyekyɛ ne OEM/ODM Adetɔfo
Saa mfonini ahorow a wɔaprapra mu foforo yi wɔ hɔ a nnuruyɛ mfiri a wɔkyekyɛ, wɔn a wɔde nneɛma ba amannɔne, ne OEM/ODM ahokafo a wɔrehwehwɛ mogya mmoroso a wɔhwɛ so ano aduru a ɛne mmara hyia ma wɔn gua ahorow no betumi asusuw ho.
Yɛgye biakoyɛ a yɛne ahokafoɔ a wɔn ani gye nneɛma nhwehwɛmu, ankorankoro nkyerɛwdeɛ nkɔsoɔ, ne gua so dwumadie mmoa ma wiase nyinaa kyekyɛ ho no tom.
Joytech Healthcare ho asɛm
Joytech Akwahosan Ho Nsɛm yɛ adwumayɛfo a wɔyɛ ofie akwahosan ne nnuruyɛ mfiri a wɔde hwɛ nneɛma so, a wɔn ho akokwaw wɔ mogya mmoroso a wɔde hwɛ, ɔhyew kyerɛwtohɔ, pulse oximeter, nebulizer, nufu mu pɔmpɛ ne akwahosan ho nneɛma afoforo mu.
Yɛde OEM / ODM aduruyɛ mfiri ano aduru wiase nyinaa akwahosan ho nneɛma a wɔde di dwuma, wɔn a wɔkyekyɛ, ne ahokafo ma, na yɛde yɛn adwene si mmara a wodi so, nneɛma a wotumi de ho to so, ne bere tenten biakoyɛ so.
Di Yɛn Nkitahodi
Sɛ wopɛ nneɛma mu nhwehwɛmu nhwɛsode, mfiridwuma ho nkrataa, anaa biakoyɛ a ɛfa yɛn FDA 510(k) cleared blood pressure monitor models, yɛsrɛ sɛ wo ne yɛn kuw no nni nkitaho.
