Izixhobo zonyango lwe-laser ze-semiconductor
Unyango lweMivi
I-DIODE LASER 1470nm+-20nm

Unyango lweMivi

Ulwazi loLawulo / ukuThotyelwa kweMithetho kunye noKhuseleko

Ihlaziywe okokugqibela: 7 Julayi 2026

Isebenza kwi: Isixhobo soNyango lweLaser seSemiconductor – Imodeli: VeinCure

Ummiselo oLawulayo: EU MDR 2017/745

1. Ukuchongwa kwesixhobo

2. Umenzi kunye nabameli abagunyazisiweyo

3Ulwazi loKhuseleko kunye nokusebenza (GSPR 23.1)

3.1 Izithintelo

Ayivumelekanga kubantu abanesifo sentliziyo, abanesifo sengqondo, abanesifo soxinzelelo lwegazi okanye abaye bafumanisa ukuba abafanelekanga kunyango lwe-laser.

Akuvumelekanga ukusebenzisa kwi-central nervous system nakwi-central circulatory system.

Akuvumelekanga ukusebenzisa i-optical fiber probe kufutshane neebrackets okanye ii-implants kuba kukho umngcipheko wokufudumeza nokutshatyalaliswa.

Ukusetyenziswa kwesixhobo esisetyenziswayo kuyachaswa ukuba, ngokoluvo logqirha oza kunyanga, indlela yotyando ayichaswanga okanye ukuba isigulane asikwazi ukwenza utyando okanye i-anesthesia ngenxa yemeko yaso ngokubanzi.

3.2 Izilumkiso kunye namanyathelo okuzikhusela

Ukhuseleko Lwamehlo: Esi sixhobo siMveliso yeLaser yeKlasi yesi-4. Imitha ethe ngqo okanye esasazekileyo inokubangela umonakalo ongenakuguqulwa kwi-retina. Bonke abasebenzi kufuneka banxibe izibuko zokukhusela amehlo (OD ≥ 4 kwi-800–1700nm) ngexesha lokusebenza. Umgama weNominal Ocular Hazard (NOHD) yi-10.5 m.

Ingozi yoMlilo: Musa ukusebenzisa amayeza okubulala iintlungu akufutshane nokutsha, amayeza okubulala iintsholongwane asekelwe kutywala, okanye ezinye izinto ezinokutsha (iidrape, iphepha).

Ukhuseleko loMbane: Qinisekisa ukuba isiseko sisemgangathweni ofanelekileyo. Musa ukususa isigqubuthelo; ulondolozo kufuneka lwenziwe ngabasebenzi abagunyazisiweyo yi-TAZLASER.

I-EMC: Musa ukusebenzisa ecaleni kwe-diathermy, i-electrocautery, okanye ii-RF emitters ezinamandla. Gcina umgama ocetyiswayo wokwahlukana nezixhobo zonxibelelwano ze-RF eziphathwayo (jonga iCandelo 4.10 le-IFU).

Ukuphathwa kweFiber: Musa ukugoba kakhulu ifiber (kufuneka kugcinwe irediyasi encinci yokugoba). Qinisekisa ukuba ifiber iqhagamshelwe ngokukhuselekileyo ngaphambi kokuba ikhutshwe.

3.3 Iingozi Eziseleyo

Nangona kusetyenziswe amanyathelo okhuseleko apheleleyo, iingozi ezibangelwa kukusetyenziswa kwelaser yeKlasi yesi-4 kunye neenkqubo zotyando azinakususwa ngokupheleleyo. Ezi ngozi ziseleyo zivavanyiwe kwiNgxelo yoVavanyo lweKlinikhi (CER, uXwebhu Nombolo TAZ-CE-TD11) kwaye zishwankathelwe apha ngezantsi:

Iingozi Eziqhelekileyo Zentsalela (Zisebenza kuzo zonke izalathisi):

Ukulimala kwamehlo: Imitha yelaser ethe ngqo okanye esasazekileyo inokubangela ukutsha okungenakulungiseka okanye ubumfama kwi-retina. (Incitshiswa kukusetyenziswa ngokunyanzelekileyo kweeglasi zokhuseleko).

Ukutsha Kwesikhumba: Ukusetyenziswa gwenxa okanye ukuxinana kwamandla kunokubangela ukwenzakala kobushushu kwizicwili ezingajoliswanga.

Ingozi yoMlilo: Amandla elaser anokutshisa izinto ezinokutsha (umz., amalaphu, ii-antiseptics ezisekelwe kutywala).

Iingozi Eziseleyo Ezichazwe Kwisalathiso:

Imithambo yeVaricose (1470nm): I-Deep Vein Thrombosis (DVT), I-Pulmonary Embolism, ukutsha kolusu, i-hematoma, i-ecchymosis, i-edema, i-paresthesia.

3.4 Iimpawu Zokusebenza

Ukuthobela iMigangatho: EN IEC 60601-1, EN IEC 60601-1-2, EN IEC 60601-2-22, IEC 60825-1, IEC 62366-1.

Uzinzo lweziphumo: Ukuphambuka phakathi kwemveliso yelaser yokwenyani nesetiweyo ≤ ±10% (Ukusebenza okubalulekileyo).

Iklasi yeLaser: Iklasi yesi-4 (Amandla aphezulu).

Icandelo eliSebenzisiweyo: Uhlobo B.

Ukhuseleko Lokungena: IPX1 (Iyunithi Ephambili); IPX8 (Utshintsho Lweenyawo).

Ubomi beNkonzo: Iminyaka emi-5 (ixesha lokusebenza).

Ukusebenza kakuhle: Esi sixhobo sifezekisa ukususwa kwezicubu ezijoliswe kuzo kunye nokususwa kwegazi emzimbeni ngokunciphisa ukopha ngexesha lotyando xa kuthelekiswa notyando oluqhelekileyo lwe-electrosurgery.

4Uhlaziyo loLawulo lwasemva kweMarike kunye noKhuseleko

Izaziso zoKhuseleko lwasentsimini (ii-FSN):

Okwangoku akukho Zibhengezo zoKhuseleko lweNdawo ezisebenzayo kwesi sixhobo.

Kwimeko yesenzo sokulungisa ukhuseleko (FSCA), eli candelo liza kuhlaziywa ngoko nangoko ngokuhambelana neCandelo le-MDR 87.

Ingxelo yeziganeko:

Abasebenzisi banyanzelekile ngokomthetho ukuba baxele naziphi na iziganeko ezinzulu ezibandakanya esi sixhobo kumenzi nakwiGunya eliGunyazisiweyo elifanelekileyo.

Uqhagamshelwano loMenzi weVigilance:lvan@tazlaser.com

Unxibelelwano lwe-EU AR:MedPath GmbH (iinkcukacha ezingentla)

5Izixhobo ezihambelanayo

Ukuqinisekisa ukhuseleko nokusebenza, kufuneka kusetyenziswe izixhobo ezihambelanayo kuphela nezihlangabezana nemigaqo elandelayo:

6Qhagamshelana nemibuzo yoLawulo

Ukuze ufumane inkxaso yemithetho, iifayile zobugcisa, okanye ulwazi olongezelelweyo lokuthobela imithetho, nceda unxibelelane no:

ISebe loMgangatho

I-Baoding Te'anzhou Electronic Technology Co., Ltd.

I-imeyile: lvan@tazlaser.com

Ucingo: +86-18331271987

Iwebhu: www.tazmedicalaser.com

I-Baoding Te'anzhou Electronic Technology Co., Ltd. (TAZLASER)^© 2026). Onke amalungelo agciniwe. Imbonakalo, inkqubo yolawulo lwehardware, kunye nesoftware yolawulo zikhuselwe lilungelo lokushicilela. Olu xwebhu okanye umxholo walo awunakutyhilwa kubantu besithathu okanye ukopishwe ngaphandle kwemvume ebhaliweyo ecacileyo. Uhlaziyo lokugqibela: 7 Julayi 2026.