I-TRIANGEL ingumkhiqizi, hhayi umuntu ophakathi nendawo
1.Siyi-aumkhiqizi ochwepheshe wemishini ye-laser yezokwelapha, i-endolaser yethu ene-wavelength ekabili engu-980nm 1470nm ithole Ukuphathwa Kwezokudla Nezidakamizwa zase-US (I-FDA) isitifiketi somkhiqizo wensiza yezokwelapha.
✅I-Food and Drug Administration (i-FDA) indikimba yase-US enomthwalo wemfanelo wokuvikela impilo yomphakathi, iqinisekisa ukuphepha kwezigaba zemikhiqizo ehlukene njengezidakamizwa, imikhiqizo yokudla, izinto zezokwelapha, izimonyo, nemikhiqizo ekhipha imisebe, (…).I-FDA iphinde ixwayise ochwepheshe bezempilo kanye nomphakathi (uma kudingekile) uma kuphakama izinkinga ngemishini ukuze kuqinisekiswe ukusetshenziswa kwayo okufanele kanye nempilo nokuphepha kweziguli.
�� Idivayisi yethu ye-laser ene-wavelength ekabili engu-980nm 1470nm iqinisekisiwe yi-FDA, iqinisekisa ikhwalithi nokuthembeka kwemikhiqizo ye-TRIANGEL emhlabeni jikelele.
2.Ukukhiqiza nokukhiqiza kwethu kuhambisana ngokuphelele nohlelo lokuphathwa kwekhwalithi yedivayisi yezokwelapha yaseChina kanyeISO13485(hhayi i-ISO9001, 9001 akuyona isistimu yokuphatha eyisibopho) isistimu yekhwalithi yedivayisi yezokwelapha, futhi izibophezele ekuhlinzekeni abasebenzisi ngokuhlinzeka abasebenzisi ngemikhiqizo esemthethweni, ethobelayo, ephephile nesebenzayo.
✅Izitifiketi ze-ISO zimelela ithuluzi elibalulekile lokufakazela ukuthotshelwa kwezinhlelo zokuphatha inqubo yebhizinisi namazinga achazwe ngamazinga obuchwepheshe.
��️ I-ISO 13485 esikhundleni salokho iyisitifiketi sekhwalithi esiqondiswe ngokukhethekile kumishini yezokwelapha, ngokuya ngezidingo nemithethonqubo ye-European Union. Iqinisekisa ikhono lenkampani lokuhlinzeka ngamathuluzi ezokwelapha namasevisi ahlobene athobela izidingo zekhasimende nemithethonqubo eyisibopho.
3.Ukuphepha kuyimfuneko kithi. Nsuku zonke thina i-Trangel sihamba emgwaqeni sibheke ekuphepheni kwemishini yethu, sihlonipha izitifiketi ezidingwa yimithetho yemishini kagesi yezokwelapha. Isifinyezo esithi CE sibonisa "European Conformity" futhi simele ukuthobela isiyalelo sokuphepha se-EU. Lokhu kwakamuva kuqinisekisa ukuthi umkhiqizo uphumelele izivivinyo zesikhashana nokuthi, ngakho-ke, ungasatshalaliswa noma yikuphi ngaphakathi kwe-European Union kanye ne-European Economic Area.
Yini Ongayilindela Ku-Triangel?
I-1.Izingxenye eziyinhloko zomshini wethu zivela e-USA, izindinganiso nezimfuneko zazo zonke izingxenye nezinto zokwakha zemishini yezokwelapha zicace kakhulu. Izingxenye ezibalulekile ezifana nokushintsha izinsiza zikagesi, amaswishi okumisa izimo eziphuthumayo, amaswishi okhiye, ama-laser, njll. kufanele zithobele izindinganiso zezokwelapha. Imishini ye-laser evamile ayidingi ukuhlangabezana nalezi zindinganiso ezinzima, ngakho-ke izindleko ziphansi kakhulu.
2.Ukuqeqeshwa nokusekelwa emtholampilo
Sinenani elikhulu labasabalalisi, odokotela kanye noprofesa bemitholampilo emhlabeni jikeleleumhlaba, ozoqinisekisa ukuthi uma uthenga imikhiqizo ye-TRIANGEL, uzoba nokuningiizixazululo zomtholampilo, izinqubo kanye nokusekelwa kwezobuchwepheshe, okwenza ukuhlinzwa kwakho kube bushelelezi futhingempumelelo kakhudlwana.
3.Iwaranti kanye nangemva kokuthengisa
Impilo yesevisi elindelekile yomkhiqizo ayikho ngaphansi kweminyaka engu-5-8 ngokusho kwedivayisi yezokwelapha.Phakathi nenkathi yewaranti yezinyanga ezingu-18, uma ingalinyazwanga izici zomuntu, inkampani yethu izohlinzeka ngesevisi yamahhala ngemva kokuthengisa.
Isikhathi sokuthumela: Mar-12-2025