An nisɔndiyara k’a fɔ ko tansiyɔn kɔlɔsili modɛli kura minnu bɛ Joytech Healthcare ka fɛn dilannenw kɔnɔ minnu bɛ yen, olu ye sɔrɔ ka ɲɛ FDA 510(k) ka yamaruya , o min b’u ka labɛnni dɛmɛ Ameriki furakɛli minɛnw sugu la.
O yamaruya in b’a jira ko nin minɛn ninnu bɛ Ameriki ka sariyaw dafa lakana ni baarakɛcogo kan i n’a fɔ furakɛli minɛnw minnu bɛ wele ko Class II , wa u bɛ bɛn kosɛbɛ ni predicate minɛnw ye minnu bɛ feere sariya siratigɛ la.
Sanfɛla tansiyɔn jateminɛcogo misali kura minnu saniyalen don
Modeli kura minnu saniyalen don, olu ye bolokɔni sanfɛla tansiyɔn jateminɛnanw ye minnu dabɔra balikuw bɛɛ kama minnu bɛ baara kɛ ni u ye so kɔnɔ ani kɛnɛyaso kɔnɔ.
Nin misali ninnu ye Joytech Healthcare ka tansiyɔn kɔlɔsili furaw labɛncogo dɔ ye , wa u bɛ labɛncogo kura ni sumanikɛcogo kura don senkan walasa ka baarakɛlaw ka dɔnniya yiriwa ani sumanikɛcogo dannaya.
U bɛ baara kɛ ni tansiyɔn sumani fɛɛrɛ ye min sinsinnen bɛ funu kan , o bɛ se ka kɛ sababu ye ka tansiyɔn sumani kɛ mansin wulituma na. O bɛ dɛmɛ ka sumanikɛcogo ɲuman ni baarakɛlaw dusu saalo ɲɛ , ka sɔrɔ ka kalan sabatilenw ni dannaya bɛ se ka da minnu kan.
Kɔlɔsili baara kɔrɔlenw ka ɲɛsin so ni kɛnɛyaso baarakɛcogo ma
Ka kɛɲɛ ni u labɛncogo ye, minɛnw bɛ se ka nin baara ninnu kɛ:
Cuff Tightness Indicator , min bɛ mansin dacogo ɲuman dɛmɛ sani a ka sumani kɛ
Excessive Movement Indicator , min bɛ dɛmɛ ka sumani sabatili ɲɛ ni lamaga kɔlɔsili ye baara kɛtuma na
AFIB (Atrial Fibrillation) detection function , min bɛ dusukun tantanni sɛgɛsɛgɛli kɛcogo jugu dɛmɛ sumani waati
MVM baarakɛcogo , min bɛ kalan caman kɛ otomatiki cɛmancɛ la walasa ka bɛnkan ɲɛ
Nin baara ninnu dabɔra walasa ka tansiyɔn kɔlɔsili dɛmɛ min bɛ se ka da a kan so kɔnɔ kɛnɛyako ni kɛnɛyaso jateminɛcogo fila bɛɛ la.
Cuff Size Configurations caman bɛ yen
Mansin hakɛ caman bɛ sɔrɔ, i n’a fɔ santimɛtɛrɛ 22–36, santimɛtɛrɛ 22–42, ani santimɛtɛrɛ 32–48 , minnu dabɔra ka balikuw bolokɔniw lamini danfaralenw ladon ani ka sumanikɛcogo ɲuman sabati baarakɛla kulu suguya caman kɔnɔ.
Fɛn minnu bɛ dilan, olu kunbabaw
FDA 510(k) ye misali kuraw jɛya tansiyɔn kɔlɔsili sira kɔrɔ kɔnɔ
Sanfɛla tansiyɔn kɔlɔsili fɛɛrɛ otomatiki
Sumanikɛcogo min sinsinnen bɛ nafolosɔrɔbaliya kan walasa ka dusudon ni baarakɛcogo ɲɛ
Mansin sirili jiralan min bɛ se ka kɛ walasa ka mansin jɔcogo ɲuman sɔrɔ
Lamaga-lamagali tɛmɛnen jiralan min bɛ se ka kɛ walasa ka lamaga-lamagali dɔn sumani kɛtuma na
AFIB ka dɔnni baarakɛcogo dusukun tantanni sɛgɛsɛgɛli dɛmɛni na min tɛ kɛ cogo la
MVM baarakɛcogo walasa ka sumani kɛcogo ɲɛ ani ka segin a kan
Mansin hakɛ caman labɛncogo balikuw ka baarakɛlaw ye
A bɛnnen don so kɔnɔ baara ma ani kɛnɛyaso jateminɛ kɛcogo la
Sariyasunw labatoli ani sugu labɛnni
FDA ka 510(k) ka yamaruya b’a jira ko Joytech Healthcare ka cɛsiri bɛ sariyaw labatoli la ani ka fɛn dilannenw jogo ɲuman jira diɲɛ kɛnɛyako suguw la, Ameriki fana sen bɛ o la.
510(k) nimɔrɔ minnu bɛ bɛn o ma , olu bɛ sɔrɔ foroba la, wa u bɛ se ka sɛgɛsɛgɛ FDA ka kunnafonidilan kɔnɔ , o bɛ kɛ sababu ye ka kɛnɛya ni tuguni kɛ.
Jɛɲɔgɔnya siraw ka ɲɛsin Jagokɛlaw ni OEM/ODM Kunnafonidila ma
Nin misali kura jɛlen ninnu bɛ sɔrɔ furakɛli minɛnw tilabagaw fɛ, u donbagaw fɛ, ani OEM/ODM jɛɲɔgɔnw fɛ minnu bɛ tansiyɔn kɔlɔsili fɛɛrɛw ɲini minnu bɛ bɛn sariya ma u ka suguw kama.
An bɛ jɛkafɔ bisimila ni jɛɲɔgɔnw ye minnu b’u mago don fɛn dilannenw jateminɛni na, mɔgɔ kelen-kelen ka taamasiyɛnw yiriwali la, ani suguw bilali dɛmɛni na diɲɛ kɔnɔ tilali kama.
Joytech Healthcare ko la
Joytech Kɛnɛyako ye so kɛnɛyako ni furakɛli kɔlɔsili minɛnw dilannikɛla ŋana ye, a ka baara ɲɛsinnen bɛ tansiyɔn jateminɛnanw, funteni jateminɛnanw, dusukun tantanni jateminɛnanw, nebulizerw, sinji pɔnpew ani kɛnɛyako fura wɛrɛw ma.
An bɛ OEM/ODM furakɛli minɛnw ɲɛnabɔcogo diɲɛ kɛnɛyako taamasiyɛnw, feerekɛlaw ani jɛɲɔgɔnw dɛmɛ, k’an sinsin sariyaw labatoli kan, ka da fɛn dilannenw kan, ani jɛkafɔ kuntaalajan kan.
Aw ye ɲɔgɔn sɔrɔ Anw fɛ
Walasa ka fɛn dilannenw jateminɛ misaliw sɔrɔ, fɛɛrɛko sɛbɛnw, walima jɛkafɔ ka ɲɛsin an ka FDA 510(k) ye tansiyɔn kɔlɔsili modɛliw jɛya, aw bɛ se ka kuma an ka jɛkulu fɛ.
