I-TRIANGEL ngumenzi, hayi umntu ophakathi
1.Siyi aumenzi oqeqeshiweyo wezixhobo zelaser zonyango, i-endolaser yethu ene-wavelength ephindwe kabini i-980nm 1470nm ifumene i-US yoKutya kunye noLawulo lweziyobisi (I-FDA) isiqinisekiso semveliso yesixhobo sonyango.
✅ULawulo lokuTya kunye neDrugs (i-FDA) liziko lase-US elinoxanduva lokukhusela impilo yoluntu, ukuqinisekisa ukhuseleko lweendidi zeemveliso ezahlukeneyo ezifana namachiza, iimveliso zokutya, izixhobo zonyango, izinto zokuthambisa, kunye neemveliso ezikhupha imitha, (…) .I-FDA ikwalumkisa abasebenzi bezempilo kunye noluntu (ukuba kuyimfuneko) xa kuvela iingxaki ngezixhobo zokuqinisekisa ukusetyenziswa kwazo okufanelekileyo kunye nempilo kunye nokhuseleko lwezigulana.
�� Isixhobo sethu selaser esinobude obuphindwe kabini obungamaza angama-980nm 1470nm ziqinisekiswe yi-FDA, ziqinisekisa umgangatho kunye nokuthembeka kweemveliso ze-TRIANGEL kwihlabathi liphela.
I-2.Imveliso yethu kunye nemveliso ihambelana ngokungqongqo nenkqubo yokulawula umgangatho wesixhobo sonyango saseTshayina kunyeISO13485(hayi ISO9001, 9001 asiyonkqubo yolawulo olusisinyanzelo) inkqubo yomgangatho wesixhobo sonyango, kwaye uzibophelele ekuboneleleni abasebenzisi ngokubonelela abasebenzisi ngeemveliso ezisemthethweni, ezithobelayo, ezikhuselekileyo nezisebenzayo.
✅Izatifikethi ze-ISO zimele isixhobo esibalulekileyo sokungqina ukuthotyelwa kweenkqubo zolawulo lwenkqubo yeshishini kunye nemigangatho echazwe yimigangatho yobugcisa.
��️ I-ISO 13485 endaweni yoko sisiqinisekiso somgangatho esibhekiselele ngokukodwa kwizixhobo zonyango, ngokweemfuno kunye nemimiselo yeManyano yaseYurophu. Iqinisekisa ukukwazi kwenkampani ukubonelela ngezixhobo zonyango kunye neenkonzo ezinxulumene nazo ezithobela iimfuno zabathengi kunye nemimiselo enyanzelekileyo.
3.Ukhuseleko luyimfuneko kuthi. Yonke imihla sihamba ngendlela esinge kukhuseleko lwezixhobo zethu, sihlonipha iziqinisekiso ezifunwa yimithetho yezixhobo ze-electro-medical. Isishunqulelo se-CE sibonisa "i-European Conformity" kwaye simele ukuthotyelwa komyalelo wokhuseleko we-EU. Le yokugqibela iqinisekisa ukuba imveliso iphumelele iimvavanyo ze-ad hoc kwaye, ke ngoko, ingasasazwa naphina kwi-European Union kunye ne-European Economic Area.
Yintoni onokuyilindela kwi-Triangel?
I-1.Iinxalenye eziphambili zomatshini wethu zivela e-USA, imigangatho kunye neemfuno zawo onke amacandelo kunye nezixhobo zezixhobo zonyango zicace kakhulu. Amacandelo aphambili afana nokutshintsha izixhobo zombane, iiswitshi zokumisa ezingxamisekileyo, izitshixo eziphambili, iilaser, njl.njl. kufuneka zihambelane nemigangatho yonyango. Izixhobo ze-laser ngokubanzi azifuni ukuhlangabezana nale migangatho ifunayo, ngoko ke ixabiso liphantsi kakhulu.
2.Uqeqesho nenkxaso yezonyango
Sinenani elikhulu abasasazi, oogqirha kunye neenjingalwazi zeklinikhi ngeenxa zonkeihlabathi, eliya kuqinisekisa ukuba xa uthenga iimveliso ze-TRIANGEL, uya kuba nokunyeizisombululo zeklinikhi, iinkqubo kunye nenkxaso yobugcisa, ukwenza utyando lwakho lula kwayeesebenzayo ngakumbi.
3.Iwaranti kunye nasemva kokuthengisa
Ubomi benkonzo obulindelekileyo bemveliso ayikho ngaphantsi kweminyaka emi-5-8 ngokwesixhobo sonyango.Kwixesha lewaranti yeenyanga ezili-18, ukuba ayonakaliswanga ngabantu, inkampani yethu iya kubonelela ngenkonzo yasimahla emva kokuthengisa.
Ixesha lokuposa: Mar-12-2025