I-TRIANGEL ingumkhiqizi, hhayi umuntu ophakathi
1. Singabantuumenzi ochwepheshe wemishini ye-laser yezokwelapha, i-endolaser yethu ene-dual wavelength engu-980nm engu-1470nm ithole i-US Food and Drug Administration (I-FDAisitifiketi somkhiqizo wedivayisi yezokwelapha.
✅I-Food and Drug Administration (FDA) yinhlangano yase-US enesibopho sokuvikela impilo yomphakathi, ukuqinisekisa ukuphepha kwezinhlobo ezahlukene zemikhiqizo njengemithi, imikhiqizo yokudla, amadivayisi ezokwelapha, izimonyo, kanye nemikhiqizo ekhipha imisebe, (…). I-FDA iphinde yazise ochwepheshe bezempilo kanye nomphakathi (uma kudingeka) lapho kuvela izinkinga ngamadivayisi ukuqinisekisa ukusetshenziswa kwawo okufanele kanye nempilo nokuphepha kweziguli.
�� Idivayisi yethu ye-laser ene-dual wavelength engu-980nm engu-1470nm iqinisekiswe yi-FDA, okuqinisekisa ikhwalithi nokuthembeka kwemikhiqizo ye-TRIANGEL emhlabeni jikelele.
2. Ukukhiqiza kwethu nokukhiqiza kuhambisana ngokuqinile nohlelo lokuphathwa kwekhwalithi yedivayisi yezokwelapha yaseShayina kanyeI-ISO13485(hhayi i-ISO9001, i-9001 akuyona uhlelo lokuphatha oluphoqelekile) uhlelo lwekhwalithi yedivayisi yezokwelapha, futhi bazibophezele ekuhlinzekeni abasebenzisi ngemikhiqizo esemthethweni, ehambisanayo, ephephile nephumelelayo.
✅Izitifiketi ze-ISO zimelela ithuluzi elibalulekile lokufakazela ukuhambisana kwezinhlelo zokuphatha izinqubo zebhizinisi nezindinganiso ezichazwe yizindinganiso zobuchwepheshe.
� I-ISO 13485 esikhundleni salokho iyisitifiketi sekhwalithi esibhekisela kuphela kumadivayisi ezokwelapha, ngokwezidingo nemithethonqubo ye-European Union. Iqinisekisa ikhono lenkampani lokuhlinzeka ngamadivayisi ezokwelapha kanye nezinsizakalo ezihlobene ezihambisana nezidingo zamakhasimende kanye nemithethonqubo ephoqelekile.
3. Ukuphepha kuyinto ebalulekile kithi. Nsuku zonke thina iTriangel sihamba ngendlela eya ekuphepheni kwamadivayisi ethu, sihlonipha izitifiketi ezidingekayo yimithetho yamadivayisi ezokwelapha kagesi. Isifinyezo se-CE sibonisa "i-European Conformity" futhi simelela ukuhambisana nesiqondiso sokuphepha se-EU. Lesi sakamuva siqinisekisa ukuthi umkhiqizo uphumelele ukuhlolwa okungahleliwe nokuthi, ngenxa yalokho, ungasatshalaliswa noma kuphi ngaphakathi kwe-European Union kanye ne-European Economic Area.
Yini Ongayilindela KuTriangel?
1. Izingxenye eziyinhloko zomshini wethu zivela e-USA, amazinga kanye nezidingo zazo zonke izingxenye nezinto zokwakha imishini yezokwelapha zicacile kakhulu. Izingxenye ezibalulekile ezifana nokushintsha amandla kagesi, ukushintsha okuphuthumayo, ukushintsha okhiye, ama-laser, njll. kumele zihambisane nezindinganiso zezokwelapha. Imishini ye-laser evamile ayidingi ukuhlangabezana nalezi zindinganiso ezidingayo, ngakho-ke izindleko ziphansi kakhulu.
2. Ukuqeqeshwa kanye nokusekelwa kwezokwelapha
Sinenani elikhulu labasabalalisi, odokotela kanye noprofesa bezokwelapha kulo lonkeumhlaba, okuzoqinisekisa ukuthi uma uthenga imikhiqizo ye-TRIANGEL, uzoba nokuningiizixazululo zezokwelapha, izinqubo kanye nokusekelwa kobuchwepheshe, okwenza ukuhlinzwa kwakho kube lula futhikusebenza kangcono.
3. Iwaranti kanye nokuthengisa ngemuva kokuthengisa
Impilo yesevisi elindelekile yomkhiqizo ingaphansi kweminyaka emi-5-8 ngokwedivayisi yezokwelapha.Kungakapheli izinyanga eziyi-18 zewaranti, uma ingonakaliswa yizinto ezibangelwa abantu, inkampani yethu izohlinzeka ngensizakalo yamahhala ngemuva kokuthengisa.
Isikhathi sokuthunyelwe: Mashi-12-2025