He mea hana ʻo TRIANGEL, ʻaʻole he mea waena
1. Hemea hana loea o nā lako laser lapaʻau, ua loaʻa i kā mākou endolaser me ka nalu pālua 980nm 1470nm ka US Food and Drug Administration (ʻAhaʻōlelo a ka FDA) ka palapala hōʻoia huahana hāmeʻa lapaʻau.
✅ʻO ka ʻOihana Meaʻai a me nā Lāʻau Lapaʻau (FDA) ke kino ʻAmelika e kuleana no ka pale ʻana i ke olakino lehulehu, e hōʻoia ana i ka palekana o nā ʻano huahana like ʻole e like me nā lāʻau lapaʻau, nā huahana meaʻai, nā mea lapaʻau, nā mea hoʻonani, a me nā huahana e hoʻopuka ana i ka radiation, (...). Hoʻomaopopo pū ka FDA i nā loea olakino a me ka lehulehu (inā pono) ke kū mai nā pilikia me nā mea hana e hōʻoia i kā lākou hoʻohana pono ʻana a me ke olakino a me ka palekana o nā maʻi.
Ua hōʻoia ʻia kā mākou mea hana laser me ka nalu pālua 980nm 1470nm e ka FDA, e hōʻoiaʻiʻo ana i ka maikaʻi a me ka hilinaʻi o nā huahana TRIANGEL ma ka honua holoʻokoʻa.
2.ʻO kā mākou hana a me ka hana ʻana e kūlike pono ana me ka ʻōnaehana hoʻokele maikaʻi o nā mea lapaʻau Kina aISO13485(ʻaʻole ISO9001, ʻaʻole 9001 kahi ʻōnaehana hoʻokele i koi ʻia) ʻōnaehana maikaʻi o nā hāmeʻa lapaʻau, a ua kūpaʻa i ka hāʻawi ʻana i nā mea hoʻohana i nā huahana kū kānāwai, kūlike, palekana a me ka pono.
✅He mea hana koʻikoʻi nā palapala hōʻoia ISO no ka hōʻoia ʻana i ke kūlike o nā ʻōnaehana hoʻokele kaʻina hana ʻoihana me nā kūlana i wehewehe ʻia e nā kūlana loea.
ʻO ISO 13485 kahi palapala hōʻoia maikaʻi e pili wale ana i nā mea lapaʻau, e like me nā koi a me nā lula o ka ʻAhahui ʻEulopa. Hōʻoia ia i ka hiki i kahi ʻoihana ke hāʻawi i nā mea lapaʻau a me nā lawelawe e pili ana e kūlike me nā koi o ka mea kūʻai aku a me nā lula i koi ʻia.
3. He mea pono ka palekana no mākou. I kēlā me kēia lā, hele mākou ʻo Triangel ma ke alanui e pili ana i ka palekana o kā mākou mau mea hana, e mahalo ana i nā palapala hōʻoia i koi ʻia e nā kānāwai ma nā mea hana electro-medical. ʻO ka pōkole CE e hōʻike ana i ka "European Conformity" a hōʻike i ka mālama ʻana i ke kuhikuhi palekana EU. Hōʻoia ka mea hope ua hala kahi huahana i nā hoʻokolohua ad hoc a no laila, hiki ke hāʻawi ʻia ma nā wahi āpau i loko o ka European Union a me ka European Economic Area.
He aha kāu e manaʻo ai mai Triangel?
1. ʻO nā ʻāpana koʻikoʻi o kā mākou mīkini mai USA mai, ua maopopo loa nā kūlana a me nā koi no nā ʻāpana a me nā mea hana āpau o nā lako lapaʻau. Pono nā ʻāpana koʻikoʻi e like me nā lako mana hoʻololi, nā kuapo hoʻōki pilikia, nā kuapo kī, nā lasers, a me nā mea ʻē aʻe e kūlike me nā kūlana lapaʻau. ʻAʻole pono nā lako laser maʻamau e hoʻokō i kēia mau kūlana koi, no laila ua emi loa ke kumukūʻai.
2. Hoʻomaʻamaʻa lapaʻau a me ke kākoʻo
He nui kā mākou mau mea hoʻolaha, nā kauka a me nā polopeka lapaʻau a puni kahonua, kahi e hōʻoia ai i ka wā e kūʻai ai ʻoe i nā huahana TRIANGEL, e loaʻa iā ʻoe nā mea hou akunā hoʻonā lapaʻau, nā kaʻina hana a me ke kākoʻo loea, e hoʻomaʻamaʻa ana i kāu ʻoki kino aʻoi aku ka maikaʻi.
3.Palapala Hoʻokō a me ke kūʻai aku ma hope
ʻAʻole emi ka manawa lawelawe i manaʻo ʻia no ka huahana ma lalo o 5-8 mau makahiki e like me ka mea lapaʻau.I loko o 18 mau mahina o ka palapala hoʻokō, inā ʻaʻole i hōʻino ʻia e nā kumu kanaka, e hāʻawi kā mākou hui i ka lawelawe ma hope o ke kūʻai aku.
Ka manawa hoʻouna: Malaki-12-2025


