FRO-203 CE FCC RR spo2 pediatric pulse oximeter home hoʻohana pulse oximeter

1. He hale hana ʻoe?

ʻO mākou ke kumu kumu o ka finger pulse oximeter. Loaʻa iā mākou kā mākou palapala hoʻopaʻa inoa huahana lapaʻau ponoʻī, hōʻoia ʻōnaehana ʻoihana hana, patent invention, etc.

Loaʻa iā mākou ma mua o ʻumi mau makahiki o ka ʻenehana a me ka hōʻiliʻili ʻana o nā mea nānā ICU. Hoʻohana nui ʻia kā mākou huahana ma ICU, NICU, OR, ER, etc.

He hale hana kumu mākou e hoʻohui ana i ka R&D, ka hana a me ke kūʻai aku. ʻAʻole wale ia, ma ka ʻoihana oximeter, ʻo mākou ke kumu o nā kumu he nui. Ua hoʻolako mākou i nā modula oxygen koko i nā mea hana inoa oximeter kaulana.

(Ua noi mākou no ka nui o nā patent invention a me nā patent hiʻohiʻona huahana e pili ana i nā algorithms software.)

Eia kekahi, loaʻa iā mākou kahi ʻōnaehana hoʻokele ISO: 13485, a hiki iā mākou ke kōkua i nā mea kūʻai aku me ka hoʻopaʻa inoa huahana pili.

2. Ua pololei anei kou pae oxygen koko?

ʻOiaʻiʻo, ʻo ka pololei ke koi kumu e pono ai mākou e hālāwai no ka hōʻoia olakino. ʻAʻole wale mākou e hoʻokō i nā koi kumu, akā noʻonoʻo mākou i ka pololei i nā hiʻohiʻona kūikawā he nui. No ka laʻana, ka hoʻoneʻe ʻana i ka neʻe ʻana, nāwaliwali ka holo ʻana o ka peripheral, nā manamana o nā mānoanoa like ʻole, nā manamana lima o nā kala ʻili like ʻole, etc.

ʻO kā mākou hōʻoia pololei ʻoi aku ma mua o 200 mau pūʻulu o ka ʻikepili hoʻohālikelike e uhi ana i ka laulā o 70% a i 100%, i hoʻohālikelike ʻia me nā hopena o ka nānā ʻana i ke kinoea koko o ke koko arterial kanaka.

ʻO ka hōʻoia pololei ʻana i ka mokuʻāina hoʻomaʻamaʻa e hoʻohana i nā mea hana hoʻoikaika kino e hoʻomaʻamaʻa me kahi alapine a me ka nui o ka paʻi ʻana, friction, random movement, etc., a hoʻohālikelike i nā hopena hōʻike o ka oximeter i ka mokuʻāina hoʻomaʻamaʻa me nā hopena o ke kinoea koko. Analyer for arterial blood Validation, he mea kōkua i kekahi mau maʻi e like me ka poʻe maʻi me ka maʻi o Parkinson e ana i ka hoʻohana. ʻO ia mau hoʻokolohua anti-hoʻomaʻamaʻa i kēia manawa ke hana wale ʻia e ʻekolu hui ʻAmelika i ka ʻoihana, masimo, nellcor, Philips, a ʻo kā mākou ʻohana wale nō i hana i kēia hōʻoia me nā oximeters manamana lima. 

3. No ke aha e loli ai ka oxygen koko i luna a i lalo?

ʻOiai ka lōʻihi o ke kahe o ke koko ma waena o 96% a me 100%, aia ia i loko o ka laulā maʻamau. ʻO ka maʻamau, paʻa ka waiwai o ka oxygen koko ma lalo o ka hanu ʻana i kahi noho mālie. He mea maʻamau ka hoʻololi ʻana o hoʻokahi a i ʻole ʻelua mau waiwai ma kahi ʻāpana liʻiliʻi.

Eia nō naʻe, inā loaʻa ka lima o ke kanaka i ka neʻe ʻana a i ʻole nā ​​​​pilikia ʻē aʻe a me nā loli i ka hanu ʻana, e hoʻoulu nui ia i ka oxygen koko. No laila, paipai mākou i nā mea hoʻohana e noho mālie ke ana ʻana i ka oxygen koko. 

4. 4S wikiwiki huahana waiwai, he maoli waiwai?

ʻAʻohe hoʻonohonoho e like me ka "waiwai i hana ʻia" a me ka "waiwai paʻa" i kā mākou koko oxygen algorithm. Hoʻokumu ʻia nā waiwai a pau i hōʻike ʻia ma ka hōʻiliʻili ʻana a me ka nānā ʻana i nā kumu hoʻohālike kino. Hoʻokumu ʻia ka hoʻopuka waiwai wikiwiki 4S ma ka ʻike wikiwiki a me ka hana ʻana i nā hōʻailona pulse i hopu ʻia i loko o 4S. Pono kēia i ka hōʻiliʻili ʻikepili nui a me ka loiloi algorithm e hoʻokō i ka ʻike pololei.

Eia naʻe, ʻo ka manaʻo no ka hoʻopuka waiwai 4S wikiwiki ʻo ia ka mea hoʻohana. Inā he neʻe i ka wā e hoʻohuli ʻia ai ke kelepona, e hoʻoholo ka algorithm i ka hilinaʻi o ka ʻikepili e pili ana i ke ʻano o ka nalu i hōʻiliʻili ʻia a hoʻonui i ka manawa ana.

5. Kākoʻo anei ia i ka OEM a me ka hana maʻamau?

Hiki iā mākou ke kākoʻo i ka OEM a me ka hana maʻamau.

Eia naʻe, no ka mea e koi ana ka paʻi pale logo i kahi pale paʻi ʻokoʻa a me nā mea ʻokoʻa a me ka hoʻokele bom, e alakaʻi kēia i ka piʻi ʻana o kā mākou huahana huahana a me ke kumukūʻai hoʻokele, no laila e loaʻa iā mākou ka palena liʻiliʻi. MOQ:1K.

Hiki ke ʻike ʻia nā hōʻailona hiki iā mākou ke hāʻawi i ka hōʻailona huahana, nā manual, a me nā logo lens.

6. Hiki ke hoʻokuʻu aku?

Loaʻa iā mākou i kēia manawa nā ʻano ʻōlelo Pelekania o ka hoʻopaʻa ʻana, nā manual a me nā pilina huahana. A ua loaʻa iā ia ka hōʻoia olakino mai ka European Union CE (MDR) a me FDA, hiki ke kākoʻo i nā kūʻai honua.

I ka manawa like, loaʻa iā mākou ka palapala kūʻai manuahi FSC (Kina a me EU)

Eia nō naʻe, no kekahi mau ʻāina kikoʻī, pono e hoʻomaopopo i nā koi komo kūloko, a pono pū kekahi mau ʻāina i kahi palapala ʻokoʻa.

I ka ʻāina hea ʻoe e lawe aku ai? E ʻae mai iaʻu e hōʻoia me ka hui inā loaʻa i kēlā ʻāina nā koi hoʻoponopono kūikawā.

7. Hiki ke kākoʻo i ke kākau inoa ʻana ma ka ʻāina XX?

Pono kekahi mau ʻāina e hoʻopaʻa inoa hou no nā ʻelele. Inā makemake kekahi luna e hoʻopaʻa inoa i kā mākou huahana ma ia ʻāina, hiki iā ʻoe ke noi i ka ʻelele e hōʻoia i ka ʻike e pono ai lākou mai iā mākou. Hiki iā mākou ke kākoʻo i ka hāʻawi ʻana i kēia ʻike:

510K palapala mana

CE (MDR) palapala ʻae

Palapala hōʻoia ISO13485

ʻIke huahana

E like me ke kūlana, hiki ke hāʻawi ʻia nā mea aʻe (pono e ʻae ʻia e ka luna kūʻai):

Hōʻike Nānā Palekana Nui no nā Lapaʻau Lapaʻau

Electromagnetic compatibility hōʻike hōʻike

Hōʻike hoʻāʻo biocompatibility

Hōʻike lāʻau lapaʻau huahana

8. Loaʻa iā ʻoe kahi palapala hōʻoia olakino?

Ua hana mākou i ka hoʻopaʻa inoa ʻana a me ka hōʻoia ʻana i ka lāʻau lapaʻau kūloko, ka palapala hōʻoia 510K a FDA, ka palapala CE (MDR), a me ka palapala ISO13485.

Ma waena o lākou, ua loaʻa iā mākou ka CE certification (CE0123) mai TUV Süd (SUD), a ua hōʻoia ʻia e like me nā lula MDR hou. I kēia manawa, ʻo mākou ka mea hana home mua o ka finger clip oximeter.

E pili ana i ka ʻōnaehana hana hana, loaʻa iā mākou ka palapala ISO13485 a me ka laikini hana home.

Eia kekahi, loaʻa iā mākou kahi palapala kūʻai manuahi (FSC)

9. Hiki paha ke lilo i ʻelele kūʻokoʻa ma ka ʻāina?

Hiki ke kākoʻo ʻia ka ʻoihana kūʻokoʻa, akā pono mākou e hāʻawi iā ʻoe i nā kuleana ʻoihana kūʻokoʻa ma hope o ka noi ʻana i ka ʻoihana no ka ʻae ʻia e pili ana i ke kūlana hana o kāu ʻoihana a me ka nui o nā kūʻai i manaʻo ʻia.

ʻO ka maʻamau he ʻāina kahi i loaʻa ai i kekahi mau ʻelele nui ka mana kūloko a me ka māhele mākeke, a makemake lākou e hoʻolaha i kā mākou huahana, no laila hiki iā lākou ke hui pū.

10. He mea hou paha kāu huahana? Pehea ka lōʻihi o ke kūʻai ʻia ʻana?

He mea hou kā mākou huahana a aia ma ka mākeke no kekahi mau mahina. Hoʻolālā wale ʻia lākou a hoʻonoho ʻia e like me nā huahana kiʻekiʻe. Loaʻa iā mākou kahi helu liʻiliʻi o nā mea kūʻai aku no nā kūʻai OEM. Ma muli o ka palapala hoʻopaʻa inoa, ʻaʻole ia i komo mana i ka mākeke FDA a me CE. E kūʻai ʻia ia ma ʻAmelika ʻĀkau a me ʻEulopa ma hope o ka loaʻa ʻana o ka palapala hoʻopaʻa inoa i Nowemapa.

11. Ua kūʻai mua ʻia kāu huahana? He aha ka loiloi?

ʻOiai he mau huahana hou kā mākou huahana, ua hoʻouna ʻia nā ʻumi kaukani o lākou i kēia manawa, a paʻa ka maikaʻi o ka huahana. Ua hana mākou i ka oximeter no nā makahiki he ʻumi, a ʻike mākou i nā pilikia manaʻo o ka mea kūʻai aku. Ua hana mākou i ka nānā ʻana i ke ʻano hana hemahema (DFMEA/PFMEA) no kēlā me kēia hemahema, mai ka hoʻolālā ʻana a me ka hoʻomohala ʻana, ka hana ʻana, ka mana o ka waiwai maka, ka nānā ʻana i ka huahana, ka paʻi ʻana.

Eia hou, loaʻa i kā mākou hoʻolālā huahana kona mau hiʻohiʻona ponoʻī, paʻakikī loa, a kiʻekiʻe loa ka loiloi o ka mea kūʻai aku.

12. He kumu hoʻohālike pilikino kāu huahana? Aia kekahi pilikia o ka hewa?

ʻO kēia kā mākou hiʻohiʻona pilikino, a ua noi mākou no kā mākou huahana hiʻohiʻona patent a me nā patent noʻonoʻo e pili ana i nā algorithms software.

He kanaka hoʻolaʻa ko kā mākou hui no ka pale ʻana i nā huahana waiwai naʻauao. Ua hana mākou i ka loiloi piha o nā kuleana waiwai naʻauao no kā mākou huahana, a ma ka manawa like i hana i kahi hoʻolālā no ka pale ʻana i ka waiwai naʻauao kūpono o kā mākou huahana a me nā ʻenehana.