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Ukusebenza kahle kweqiniso ku-infrared face wand akuveli ekufudumaleni okuphezulu kodwa ekusetshenzisweni okunembile kwezimiso ze-biophysical. Ngokusebenzisa ubude be-wavelengths obuthile be-infrared obusebenza kahle kakhulu ngaphakathi kobubanzi be-880905nm lawa madivayisi aklanyelwe ukungena kwesikhumba okuqondiwe. Lolu hlelo lokulethwa lubangela impendulo yokucindezeleka kwamaseli elawulwayo nezuzisayo ngaphakathi kwama-fibroblast, ngaleyo ndlela kukhuthazwe ukwenziwa kwe-collagen kanye nezindlela zokulungisa amaseli ngaphandle kokubangela umonakalo wokuvuvukala. Umehluko kumathuluzi alula okushisa ungalinganiswa, uncike ezilinganisweni eziqinisekisiwe ezifana nokuqina kwamandla okwelapha kanye nezakhiwo zokuphepha eziqinile ezinokulawulwa kokushisa kwesikhathi sangempela. Inhloso ukufeza umphumela wokuvuselela olinganisekayo ezingeni lamaseli, ukusekela impilo yesikhumba yangempela, yesikhathi eside ngaphezu kokuzwa kwesikhashana.
Amandla okuvuselela ukukhanya kwe-infrared alawulwa ngokuyisisekelo yiphrofayili yayo yokungena encike kubude be-wavelength. I-spectrum ye-near-infrared, ikakhulukazi ngaphakathi kwefasitela elingu-880905nm, yenziwe ngokwesayensi ukuze ifinyelele ungqimba lwesikhumba lwe-dermis olugcina ama-fibroblast akhiqiza i-collagen. Le bandwidth ekhethiwe iletha amandla e-photon ngqo kula maseli aqondiwe, asebenza ngesimiso se-photobiomodulation engashisi. Le nqubo inika amandla i-mitochondria yamaseli, ikhulisa ukukhiqizwa kwe-ATP futhi isebenze izindlela zokubonisa ezikhuthaza i-neocollagegenesis. Ngenxa yalokho, kokubili ukuphepha nokusebenza kahle kokwelashwa kusekelwe kumapharamitha aqondile okukhanya, okuqinisekisa ukuthi amandla afinyelela indawo yawo ehlosiwe yezinto eziphilayo ukuze kukhuthazwe ukuvuselelwa kwesakhiwo.
Indlela yokuhlela kanye nokugunyazwa kwe-US Food and Drug Administration yamadivayisi ezokwelapha isekelwe emikhiqizweni ehloselwe ukusetshenziswa kanye nezimangalo ezihambisana nayo. Amadivayisi akhangiswayo ukuze axilonge, elaphe, noma anciphise isimo sezokwelapha, njengezinduku ezithile zobuso ze-infrared, alawulwa ngaphakathi kohlelo olusekelwe engcupheni. Iningi liwela ngaphansi kweSigaba II, okudinga isaziso sangaphambi kwemakethe esingu-510(k). Le nqubo ibopha abakhiqizi ukuthi banikeze ubufakazi obuningi besayensi obuhlanganisa ukuphepha kokushisa, ukuhambisana kwezinto eziphilayo, kanye nedatha yokusebenza okubonisa ukulingana nedivayisi ebikezelayo ethengiswa ngokusemthethweni. Igama elithi "FDA-cleared" lisho lokhu kubuyekezwa okuzimele, okusungula umkhawulo obalulekile emikhiqizweni ekhangiswa kuphela ngenxa yenhlalakahle jikelele, engenalo ukwesekwa kobufakazi obuqinisekisiwe kanye nokuvikelwa kwabathengi.
Ucwaningo lwezokwelapha ngamadivayisi obuso be-infrared luveza indawo enezici lapho idatha yemishini ye-in vitro ethembisayo kufanele ihunyushwe ibe yimiphumela eqinile yabantu. Ngenkathi amaza athile obubanzi ekhombisa ngokusobala ukuthi avuselela umsebenzi we-collagen ezindaweni zelebhu, ukusebenza kwezokwelapha kuncike ekwakhiweni kwesilingo somuntu okuqinile. Ukuhlaziywa kokuqonda kumele kudlule ngale kwezimangalo zokuphromotha ukuze kuhlolwe izindlela zokufunda: ukusetshenziswa kwamaqembu okulawula afanele, izinqubo eziphuphuthekisayo, izilinganiso ze-biometric eziqondile uma kuqhathaniswa nokuhlolwa komuntu siqu, kanye nokuphathwa kokungqubuzana okungenzeka kwezintshisekelo. Lokhu kuhlola okubucayi kuhlukanisa isayensi eqinisekisiwe nokumaketha, kugcizelela ukuthi izifundo zesikhathi eside ezenziwe ngokuzimela, ezineziphetho ezinengqondo zomtholampilo zakha isisekelo esibalulekile sokusungula ukusebenza kahle kwangempela kokwelapha.
Ukuphathwa kwezingozi okuphezulu kwakha isiyalo esisebenzayo, esigxile ezinhlelweni esihlanganiswe kuyo yonke impilo yomkhiqizo. Kuqala ngobunjiniyela obubekezelela amaphutha futhi kunwebeka ekuqinisekiseni ukubhekwa kweketanga lokuhlinzeka, ukulawulwa kokukhiqiza okuqinile, kanye nokuqapha okuqaphile ngemuva kwemakethe. Lolu hlaka lulindele ukusetshenziswa kabi okubikezelwayo ngokuklama okunembile kanye nezinqubo zomsebenzisi ezisezingeni. Luphinde lusebenzise idatha yokusetshenziswa ehlanganisiwe, engaziwa ukuze kuqhutshekwe kuhlanzwe amamodeli okuphepha kanye nokuhlolwa kwezingozi. Ekugcineni, ukuphathwa kwezingozi okuphumelelayo kuxhumanisa ubuqotho behadiwe, isiqondiso sokuziphatha, ubuhlakani bedatha, kanye nokuxhumana okusobala, okuguqula ukuthobela imithetho kube isiko eliqinile elizinikele ekuvikelweni komsebenzisi okuqhubekayo.
Abathengi abaqondayo kufanele babeke phambili amadivayisi anezincazelo ezisekelwe ebufakazini bezokwelapha. Imingcele ebalulekile okufanele ihlolwe ifaka:
Umkhiqizo othembekile uzovumelanisa ngokusobala izimangalo zawo zokumaketha nalezi zincazelo zobuchwepheshe ezilinganiswayo futhi unikeze idatha yokuphepha efinyelelekayo, okunika amandla ukwenza izinqumo ezisekelwe ebufakazini.
Uyini umehluko phakathi kwethuluzi lokushisa elilula kanye nenduku yobuso ye-infrared esebenzayo?
Umehluko oyinhloko usekusetshenzisweni kwezimiso ze-biophysical. Induku yobuso ye-infrared esebenza kahle inikeza ubude be-wavelength obuthile be-infrared (obuphakathi kuka-880-905nm) bokungena kwesikhumba okuqondiswe ngqo ukuze kukhuthazwe ama-fibroblast akhiqiza i-collagen. Isebenza nge-photobiomodulation engashisi, ibangela impendulo ewusizo yokucindezeleka kwamangqamuzana ukuze kubuyiselwe isikhumba sangempela. Ngokuphambene nalokho, ithuluzi elilula lokushisa linikeza kuphela ukufudumala okuphezulu futhi alinazo izilinganiso eziqondile zokukhanya kanye nobuningi bamandla okwelapha obudingekayo ukuze kuqinisekiswe ukuvuselelwa kwesakhiwo okulinganiselwe, kwesikhathi eside.
Ngingazi kanjani ukuthi induku yobuso ye-infrared iphephile futhi iqinisekiswe ngokwesayensi?
Funa imvume ecacile yokulawula evela ezinhlanganweni ezigunyaziwe njenge-US FDA, ikakhulukazi igama elithi "FDA-cleared" lamadivayisi ezokwelapha eSigaba II, elidinga ukuthi umenzi athumele ubufakazi besayensi obuningi ngokuphepha nokusebenza. Futhi, hlola imininingwane yobuchwepheshe yedivayisi, njengobude bayo obuqinisekisiwe ngaphakathi kobubanzi bokwelapha (isb., 880-905nm), ubuningi bamandla obulinganiselwe, kanye nezici zokuphepha ezakhelwe ngaphakathi njengezishintshi zokusika ukushisa okuzenzakalelayo kanye nama-timer eseshini. Umkhiqizo othembekile uzovumelanisa ngokusobala izimangalo zawo zokumaketha nale datha elinganisekayo futhi unikeze ulwazi lokuphepha olufinyelelekayo.
Ingabe i-FDA clearance isho ukuthi induku yobuso ye-infrared ifakazelwe ukuthi iyasebenza ekulweni nokuguga?
Akunjalo ngempela. Imvume ye-FDA (njenge-510(k)) ngokuyinhloko iqinisekisa ukuthi idivayisi ilingana kakhulu nedivayisi ekhona ethengiswa ngokusemthethweni ngokuphepha kanye nokusetshenziswa okuhlosiwe. Kuyisivikelo esibalulekile kodwa akuqinisekisi ngokuzimela ukusebenza kahle kwezimangalo ezithile zokulwa nokuguga. Lesi sihloko sigcizelela ukuthi ukusungula ukusebenza kahle kwangempela kokwelapha kudinga izivivinyo zemitholampilo zabantu eziqinile, ezenziwe ngokuzimela ezinezilinganiso eziqondile kanye nokulandelela kwesikhathi eside ukuze kuhunyushwe idatha ethembisayo yangaphakathi kwe-vitro ibe yimiphumela yabantu eqinisekisiwe. Abathengi kufanele bahlole ubufakazi bemitholampilo ngemuva kwezimangalo zokusebenza kahle.
Yiziphi izici zokuphepha ezibalulekile okufanele ngizibheke endukwini yobuso ye-infrared?
Beka phambili amadivayisi ngobunjiniyela bokuphepha obuphelele, obunezingqimba eziningi. Izici eziyisisekelo zifaka: ukulawulwa kokushisa kwesikhathi sangempela ukuvimbela ukushisa ngokweqile, ukuqina kobude besikhathi ukuqinisekisa ukuthi amandla alethwa ngaphakathi kwefasitela lokwelapha elihlosiwe, kanye nemijikelezo yomsebenzi elawulwayo (izibali-sikhathi ezenzakalelayo) ukuvimbela ukusetshenziswa ngokweqile. Ngaphezu kwalokho, funa izixhumanisi zomsebenzisi ezinembile ezinikeza imihlahlandlela ecacile yokuphikisana. Amadivayisi aphezulu asebenzisa indlela yokuphatha ingozi eqondiswe ezinhlelweni ehlanganisa ukwakheka okubekezelela amaphutha kanye nokuqapha kwangemva kwemakethe ukuze kuhlanzwe ukuphepha ngokuqhubekayo ngokusekelwe kudatha yokusetshenziswa yangempela.
Ukukhanya kwe-infrared okuvela kulezi zinduku kuzuzisa kanjani isikhumba?
Uma isebenza ngaphakathi kwe-spectrum eseduze ne-infrared efanele (isb., 880-905nm), ama-photon okukhanya angena ku-dermis, ungqimba lwesikhumba oluqukethe amaseli akhiqiza i-collagen abizwa ngokuthi ama-fibroblast. Le nqubo, eyaziwa ngokuthi i-photobiomodulation, iletha amandla ngqo kula maseli aqondiwe ngaphandle kokukhiqiza ukushisa okukhulu. Amandla amuncwa yi-mitochondria yamaseli, okwandisa ukukhiqizwa kwe-ATP (amandla amaseli) futhi kusebenze izindlela zokubonisana. Lokhu kuvuselela ama-fibroblast ukwandisa ukwakheka kwe-collagen (neocollagegenesis) futhi kukhuthaza izindlela zokulungisa amaseli, okuholela ekuvuseleleni kwesikhumba kwesakhiwo kanye nezinzuzo zezempilo zesikhathi eside.

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