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Sinbara pɔnpe fɛnw, a fɛnw ani a tiɲɛni sɛbɛnw: sariya labatoli sɛgɛsɛgɛli sɛbɛn min bɛ kɛ ka ɲɛsin markatigiw ma minnu bɛ a dilabaga sugandi

Views: 0     Author: Site Editor Bɔli waati: 2026-09-18 Bɔyɔrɔ: Yɔrɔ

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Ni a sinji pɔnpe  porogaramu bɛ bɔ hakilina na ka taa a dilanni na, a ka c’a la, jago baro bɛ daminɛ ni foroko ye, ni sumaya cogoyaw, ani sɔngɔ ye. Baro min bɛ kɛ sariya labatoli kan, o bɛ daminɛ yɔrɔ wɛrɛ la: nɔnɔ pɔnpe bɛ maga min na tiɲɛ na, yɔrɔ minnu bɛ ci kɛsu kɔnɔ, ani sɛbɛn minnu dilannikɛla bɛ se ka minnu dilan ni sariyasunba dɔ, jɛkulu ladɔnniyalen dɔ, walima feerekɛlaw ka sariya labatoli jɛkulu dɔ y’u ɲini.

Kɛrɛnkɛrɛnnenya la sannikɛlaw ni OEM sannikɛlaw fɛ, barajuru pɔnpe minɛnw, barajuru pɔnpe fɛnw, ani barajuru pɔnpe tiɲɛni sɛbɛnw tɛ baarakɛcogo saba danfaralenw ye. U ye sigida kelen ye, wa danfara bɛ u dɔ la kelen na, o bɛ teli ka bɔ kɔfɛ — i n’a fɔ mɔgɔ tɔgɔ sɛbɛnni kɔtigɛlen, suguba kɔnɔ lisi bɔli, walima garanti ɲinini min bɛ taa yɔrɔ dɔ la mɔgɔ si ma min sɛbɛn.

Sin pɔnpe minɛnw  — Fɛn minnu ka kan ka sɛgɛsɛgɛ nɔnɔ ni ɲɔgɔn cɛ yɔrɔ la

Kuran sinji pɔnpe ta fan fɛ, fɛnw ɲininkali tɛ caman kɛ ni so kulɛri walima jiralan fini ye. A bɛ a sinsin yɔrɔw kan minnu bɛ ɲɔgɔn sɔrɔ sinji walima sinji la: sinji tangalan walima sinji, nɔnɔ lajɛminɛn ni buteli, dawolo ni fɛnɲɛnamafagalan, tubabukan o tubabufura, ani sigilanw ni ɲɔgɔn cɛsira minnu bɛ sumaya sira kɔnɔ.

Dilancogo latigɛ fila ye o baara hakɛ sigi sani sɛgɛsɛgɛli si ka ɲini:

Sistɛmu da wulilen ni sitɛmu dagalen. Pɔnpe dagalen kɔnɔ, farikolo barikalan dɔ bɛ nɔnɔ bɔ tubabukan na ani ka a yɔrɔ janya motɛri ni fiɲɛ sira la. O bɛ dan sigi nɔnɔ sɔrɔyɔrɔ la ka se nɔnɔ lajɛlan ma ani ka dɔ bɔ fɛnw hakɛ la minnu mago bɛ nɔnɔ sɔrɔli daliluw la.

Yɔrɔ minnu bɛ se ka baara kɛ kokura ni nɔnɔ ye minnu bɛ se ka kɛ siɲɛ kelen. Yɔrɔ minnu dabɔra ka segin-ka-bɔnye kɛ, i n’a fɔ flansɛw ni fɛnw lajɛlanw, olu mago bɛ saniya ni baarakɛcogo kura tiɲɛni na, yɔrɔ minnu bɛ kɛ siɲɛ kelen, olu tɛ o kɛ.

Tablo min bɛ duguma, o bɛ fɛn minnu jira, a ka c’a la, markatigi ka kan ka minnu sɛmɛntiya, yɔrɔ ni yɔrɔ.

Component (yɔrɔ) yɔrɔ

Materiel jɔyɔrɔ min bɛ kɛ cogoya la

Markatigi ka kan ka min sɛmɛntiya

Sinbara lamini / flange

Silikoni walima polimɛri gɛlɛn min bɛ ɲɔgɔn sɔrɔ sinji ni nɔnɔ na

Biocompatibility daliluw fari ni nɔnɔ sɔrɔli kan; bonya ni muɲuli fɔlenw; cogo min na hakɛ sugandilenw bɛ ɲɛfɔ fɛɛrɛko dosiye kɔnɔ

Koleksi minɛn, buteli, valve, membrane

Dumuni ni ɲɔgɔn cɛ polimɛri ni elastomɛri yɔrɔw nɔnɔ sira la

Dumuni-ɲɔgɔn-ɲini sariya labatoli taayɔrɔ sugu la; BPA tɛ min na, o fɔli; saniya ni banakisɛfagalanw tali cikanw fɛn in bɛ tiɲɛ ka se ka muɲu

Tubabukan ni suction-path sigilanw

Elastomɛri tubabukan ni ɲɔgɔndanw

Ni a dilanni ye sigida datugulen ye (nɔnɔ tɛ tubabukan na); ni da wulilen don, nɔnɔ ni ɲɔgɔn cɛ daliluw ani a falen waatiw

Motɛri so, a ɲɛminɛbagaw, fanga

Ɛntɛrinɛti plastiki, jiralan, batiri

Kuran lakanani ni EMC daliluw kuran sigicogo kan; labeli, taamasiyɛn, ani kanko wajibiyalenw

Foroko ni sɛbɛnw dilanni

Kartɔn, inserts, IFU

Bololabaara ni a marali waati dantigɛli yɔrɔ minnu na a bɛ se ka kɛ; IFU kanko dafalen don yɔrɔ sugu kelen-kelen bɛɛ la

Dɛsɛ cogoya kelen min bɛ segin-ka-bɔ, o nafa ka bon ka tɔgɔ fɔ. Markatigi dɔ bɛ sɔn misali dɔ ma cogoya kelen kɔnɔ; o kɔfɛ, a dilanni bɛ elastomɛri sɔrɔyɔrɔ filanan bila valve nɔ na, ​​walima silikɔni suguya wɛrɛ bɛ bila flansɛ nɔ na. O nɔnabila bɛ se ka baara kɛ cogo kelen na, nka sɛbɛnw sigilen tɛ tiɲɛ ye sisan. O la, fɛn minnu bɛ ɲɔgɔn sɔrɔ nɔnɔ na, ​​olu kɔlɔsili ka kan ka bɛnkan sɛbɛn sɛbɛn kɔnɔ sani u ka kɛ jamaba la, u man kan ka kumaɲɔgɔnya kɛ ni batɛmu dɔ bɛ ji kan.

Sinbara pɔnpe fɛnw  — Yɔrɔ minnu na sariya labatoli porogaramuw ka teli ka sɛgɛn

Fɛnɲɛnɛmafagalanw bɛ sariya labatoli farati min tɛ bɛn ɲɔgɔn ma, o ta bawo u bɛ SKU jate caya ani ka fɛn caman Changer ka tɛmɛ pɔnpe yɛrɛ kan. Basi kelen bɛ se ka fɛn tan ni fila labɛn minnu bɛ se ka feere ni flansɛ hakɛw, buteliw ani tacogo suganditaw jatera.

  • Sinbara lamini hakɛ. Barajuru min janya ye milimɛtiri 24 ye, o ye sariya ye min bɛ kɛ tuma bɛɛ, ni hakɛ minnu bɛ se ka kɛ, olu bɛ sɔrɔ o plateforme kelen kan. Bonya kelen-kelen bɛɛ ye yɔrɔ danfaralen ye n’a yɛrɛ ka ja ni baarakɛminɛnw ye, wa u kelen-kelen bɛɛ ka kan ka jira fɛnsɛbɛnni dafalen kɔnɔ sanni u ka jate i n’a fɔ basigi yɔrɔ dɔ.

  • Butɛriw ni dumuni minnu bɛ tali kɛ dumuni na. Ni porogaramu dɔ bɛ buteliw walima nɔnɔ marayɔrɔw ci, denmisɛnw ka baara kɛcogo ni dumuniko wajibiyalenw i n’a fɔ EN 14350 bɛ se ka kɛ minɛn wajibiyalenw kɛrɛfɛ, ka kɛɲɛ ni a yɔrɔ ni sugu ye.

  • Valve, membrane ani tubabufura. O yɔrɔ minnu bɛ se ka dun, olu bɛ sanni segin-segin ni feereli kɔfɛ baara bila sen kan. Yɔrɔw jiracogo minnu dabɔra, olu ka kan ka datugu, wa fɛn dɔ caman cili ka kan ka jate i n’a fɔ sɛbɛnniko, a man kan ka jate iko fɛn dilanni kunnafoni.

  • Spare-part ani baarakɛcogo fɛɛrɛ. Marka tigiw ka kan k’a ɲɛfɔ fɛn minnu bɛ dilan i n’a fɔ fɛn minnu bɛ dilan i n’a fɔ fɛnw, u sɔrɔli finɛtiri laɲininen, ani ni feerekɛlaw bɛ komandi kɛ kokura ka kɛɲɛ ni o fɛn kɔrɔsilen kelen ye.

  • Fɛn minnu bɛ kɛ ka kɛɲɛ ni mɔgɔw sago ye. Logo, kulɛri ani barajuru hakɛ de ka ca LD seriyali porogaramuw la. U kelen-kelen bɛɛ ye labɛn ye, wa u kelen-kelen bɛɛ ka kan ka jira fɛn ɲɛfɔlen kɔnɔ min dagalen don walasa fɛn min cilen don, o lisi kɔnɔkow, ani fɛɛrɛbɔ dosiye ka fɛn kelen ɲɛfɔ.

Sinbara pɔnpe tiɲɛni sɛbɛnw  — Sɛgɛsɛgɛli sɛbɛn min ka kan ka ɲini

O yɔrɔ ɲɛnabɔcogo jɛlen ye sɛgɛsɛgɛli sɛbɛn ye min bɛ ci a dilabaga ma sanni porogaramu ka di. Seti tigitigi bɛ bɔ baarakɛcogo laɲininen na, danfara, ani taayɔrɔ suguya la, wa dilanbaga ka kan ka sɔn k’a fɔ ka jɛya ni kulu dɔ tɛ tali kɛ sanni ka seere caman ci a nɔ na.

Sɛbɛnw suguya

A ka c’a la, a bɛ min ɲɛfɔ

Mun na markatigi mago bɛ a la

Jogoɲumanya siratigɛ la

ISO 13485 seere min bɛ ni a bonya fɔlen ye; MDSAP yɔrɔ min na a bɛ se ka kɛ

A bɛ sɛbɛn tɔw bɛɛ sinsin ani a bɛ ɲini tuma bɛɛ feerekɛlaw ni jɛkulu ladɔnniyalenw ka jatebɔw la

Biocompatibilité (Biyocompatibilité) ye

Fari ni nɔnɔ bɛ se ka ɲɔgɔn minɛ fɛn minnu na, olu jateminɛni ka kɛɲɛ ni ISO 10993 seriyali ye, ka fara kemikaliya taamasiɲɛw kan, u bɛ kɛ yɔrɔ minnu na

A bɛ dɛmɛ don fɛnw jirali la fɛɛrɛko sɛbɛnw kɔnɔ

Dumuni ni ɲɔgɔn cɛ ani fɛnw labatoli

Dumuni-sɔrɔ-yɔrɔ-sɔgɔli wajibiyalenw nɔnɔ-sira polimɛriw la; BPA tɛ min na, o fɔli; RoHS ani REACH yɔrɔ minnu na a bɛnnen don

A bɛ nɔnɔ minɛ walima ka a lase yɔrɔ minnu ma, ani ɛntɛrinɛti ni polimɛri yɔrɔw datugu minnu bɛ dantigɛli kɛ fɛnw kan

Faratiw kunbɛnni

ISO 14971 faratiw ɲɛnabɔli dosiye kuncɛlen modeli in kama

Fɛn min wajibiyalen don fɛɛrɛko sɛbɛnw na; bɛ baarakɛcogo ni IFU ka latigɛw dɛmɛ

Kuranko lakanani ani EMC

Kɔrɔbɔli rapɔɔriw kuran cogoya kan ka kɛɲɛ ni IEC 60601-1 ani IEC 60601-1-2 ye

Dalilu jɔnjɔn minnu b’a jira ko sinji pɔnpe min bɛ baara kɛ ni fanga ye, o sɛbɛnni

Baara kɛcogo sɛgɛsɛgɛli

Sugunɛ hakɛw, cogoyaw, ani fɛnɲɛnamafagalan danw sɛgɛsɛgɛli dilan ka kɛɲɛ ni fɛn ɲɛfɔlenw ye

A bɛ baarakɛcogo fɔlenw dɛmɛ ani ka fɛn dilannenw suguyaw faranfasi walasa ka kanw sigicogo jira

Saniya, banakisɛfagalanw tali, ani baara kɛli kokura

Saniya taabolo min ɲɛfɔlen don IFU kɔnɔ, o tiɲɛni, ka fara baarakɛcogo kura kɛcogo kunnafoniw kan nɔnɔ ni ɲɔgɔn cɛ yɔrɔw la minnu bɛ se ka baara kɛ kokura

A bɛ cikan bɔlenw mara ka bɛn ni fɛnw kɛcogo kɔrɔbɔlen ye

Pakew dilanni, u tacogo, ani u sɛbɛnni

Bololabaara ni pakew tiɲɛni ni a bɛ se ka kɛ yɔrɔ minnu na; labeli, IFU, ani UDI kunnafoniw

A bɛ dɔ bɔ tɛmɛsira-tiɲɛni fɔlenw na ani ka sugu yamaruya dɛmɛ

Sariyasunba ni suguya sɔrɔli

Bɛnkansɛbɛn jirali, seereyaw minnu bɛ sirataama modɛli kelen-kelen bɛɛ kan i n’a fɔ CE MDR, ani 510(k) cogoya ni a bɛnnen don

A b’a Jira ko sugu minnu na cogoya tigitigi bɛ Se ka Dòn tiɲɛ na

Delina fila b’a to nin sɛgɛsɛgɛli sɛbɛn bɛ baara kɛ. Fɔlɔ, sɛbɛnw ɲini modɛli kelen-kelen bɛɛ la ani cogoya kelen-kelen bɛɛ la, bawo sosiyete ka seere tɛ foyi fɔ unit min bɛ komandi. Filanan, a ɲini sɛbɛnw lisɛli ka lajɛ kokura tuma o tuma ni nɔnɔ-minɛn, fɛn dɔ walima fanga cogoya dɔ Changé — o ye waati tigitigi ye, porogaramu min bɛ sariya labato, o bɛ kɛ porogaramu ye min tɛ sariya labato ni dususuma ye.

Joytech bɛ dɛmɛ don cogo min na Markatigiw ka sariya labatoli porogaramuw la

Joytech Healthcare  bɛ sinji pɔnpew dilan LD seriyali kɔnɔ, o ye suguya ye min bɛ kuran, kuran fila, chargeable ani bololabaarakɛcogo kɔrɔw la.

  • Nɔnɔ ni ɲɔgɔn cɛ dilancogo. LD seriyali modɛliw bɛ fɛnw fɔ minnu tɛ BPA ye, barajuru min janya ye milimɛtɛrɛ 24 ye i n’a fɔ a bɛ kɛ cogo min na ni hakɛw ye minnu bɛ se ka kɛ, ani modɛliw kan i n’a fɔ... LD-209  ye sigida dagalen ye, min bɛ kɔsegin kɛlɛ, a yɔrɔw bɛ se ka bɔ ɲɔgɔn na pewu, minnu saniya ka nɔgɔn.

  • Plateforme minnu bɛ se ka labɛn. Pɔnpe cogo naani minnu bɛ sumaya hakɛ kɔnɔntɔn kɔnɔ, LED jiralan, sufɛlanpan min bɛ se ka sugandi, ani batiri litiyamu min bɛ se ka charge (sara) kokura, Type-C, walima AA fanga, o b’a to marka dɔ ka doncogo, sariyakolo, ani fɛn caman wɛrɛw ɲɛfɔ ka bɔ kɛnɛ kelen kan.

  • Jogoɲumanya ni seereyaw. Fɛn dilanni sigilen bɛ ISO 13485, MDSAP, ani BSCI ka seereyaw jogoɲumanya siratigɛw kɔrɔ, ni CE MDR ni FDA ka baarakɛcogo bɛ sɔrɔ modeli sugandilenw kan. Seereyaw dafalen bɛ dafa modeli kelen-kelen bɛɛ la ani sugu kelen-kelen bɛɛ la sanni ka kɛ yɔrɔ bɛɛ la.

  • Ka kɛɲɛ ni mɔgɔw sago ye. Logo, kulɛri ani barajuru hakɛ ladamuni bɛ dɛmɛ OEM ni ODM porogaramuw kɔnɔ.

  • Seko ni dɔnko ni ɛntɛrinɛti. fɛn dilanyɔrɔ 3, m⊃2 260.000; ka otomatiki yɔrɔw, fɛn dilanni sira 30+, kokuradonni 100+ minnu ye patenti sɔrɔ, ani barajuru pɔnpe R&D jɛkulu min y’a yɛrɛ di ani fɛn dilanni siraw dɛmɛni porogaramuw ka baarakɛcogo.

Jɛɲɔgɔnya kɛ ni Anw ye

Sin pɔnpe porogaramu bɛ se ka lafasa dɔrɔn i n’a fɔ sɛbɛnw minnu bɛ a ka fɛnw ni a kɔnɔfɛnw kɔfɛ. Joytech bɛ baara kɛ ni feerekɛlaw ye, fɛntigiw, ani OEM/ODM sannikɛlaw ye walasa ka nɔnɔ-minɛnw sugandili, a dɛmɛnanw labɛncogo, ani u tiɲɛni sɛbɛnw bɛn suguw ma, porogaramu dɔ jɔra minnu kama.

Walasa ka baro kɛ sinji pɔnpe porogaramu kan, ka sɛbɛnw sɛgɛsɛgɛli sɛbɛn ɲini, walima ka jateminɛ kɛcogo labɛn, aw bɛ se ka kuma sale14@sejoy.com.

barajuru pɔnpe minɛnw, a dɛmɛnanw, ani a tiɲɛni documentation.jpg

Ɲininkaliw

J1: Sin pɔnpe minɛn jumɛnw de ka kan ka sɛbɛnw ɲini kosɛbɛ?

Yɔrɔ minnu bɛ maga sinji la walima sinji la, olu bɛ wajibi gɛlɛnba ta: sinji tangalanw, fɛnw lajɛlanw, buteliw, dawolo, fɛnɲɛnamafagalanw, ani tubabufura walima sigilan fɛn o fɛn bɛ sumaya sira la. A ka c’a la, sow ni jiralanw bɛ datugu ni kuran lakanani, EMC, ani fɛnw dantigɛli daliluw ye o nɔ na.

J2: Yala sinji pɔnpe minɛnw datugulen don ni sɛbɛn kelenw ye ni pɔnpe ye wa?

A tɛ kɛ a yɛrɛma, wa o ye danfara ye min bɛ kɛ tuma bɛɛ. Fɛn minnu bɛ kɛ ka fɛnw kɛ i n’a fɔ flansɛ hakɛ caman ɲɔgɔn falen, buteliw, ani fɛn minnu bɛ bila u nɔ na, ​​olu bɛ se ka u yɛrɛ ka dumunikɛminɛnw, denmisɛnw baaracogo, walima fɛnw wajibiyalenw jira ka fara pɔnpe ka minɛn sɛbɛnw kan. Accessoire configuration kelen-kelen bɛɛ ka kan ka dafa ka kɛɲɛ ni destination sugu ye.

J3: Danfara jumɛn bɛ sosiyete ka seere ni modɛli kɛrɛnkɛrɛnnenw ka dantigɛli sɛbɛnw cɛ?

Sosiyete ka seere, i n’a fɔ ISO 13485 scope seere, o bɛ jogoɲumanya siratigɛ ɲɛfɔ. Modeli kɛrɛnkɛrɛnnenw ka dantigɛli sɛbɛnw bɛ fɛn tigitigi ɲɛfɔ min bɛ komandi — a kɔnɔfɛnw, a kɔnɔfɛnw, a kuran cogoya, ani a baarakɛcogo sɛgɛsɛgɛlen. A ka c’a la, feerekɛlaw ni sariyasunbatigiw bɛ o fila bɛɛ makɔnɔ, wa filanan ye min bɛ dɛmɛ don sɛbɛnni kɛrɛnkɛrɛnnen dɔ la.

 NO.365, Wuzhou sira kan, Hangzhou, Zhejiang mara la, 311100, Sinuwa jamana na

 No.502, Shunda sira kan, Hangzhou, Zhejiang mara la, 311100, Sinuwa jamana na
 

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