- Iimveliso
- Iimveliso eziQinisekisiweyo yi-CE
- I-Diode Laser eyi-980nm 1470nm yotyando lobuhle
- I-980nm 1470nm Diode Laser yePhlebology kunye notyando lwemithambo yegazi
- I-Diode Laser ye-980nm 1470nm yeColoproctology
- I-Diode Laser ye-980nm 1470nm ye-Gynecology
- I-Laser yeDiode ye-980nm 1470nm ye-Ent
- I-Diode Laser ye-980nm 1470nm ye-Orthopedics
- I-Laser yeDiode engu-980nm 1470nm yePhysiotherapy
- I-Laser yeDiode engu-980nm 1470nm yoBugqirha baMazinyo
- I-Laser yeDiode ye-980nm 1470nm yePodiatry
Izixhobo zonyango lwelaser ze-semiconductor
TR-B
I-DIODE LASER 980nm+-20nm
I-DIODE LASER 1470nm+-20nm
TR-B
Ulwazi loLawulo / ukuThotyelwa kweMithetho kunye noKhuseleko
Ihlaziywe okokugqibela: 7 Julayi 2026
Isebenza kwi: Isixhobo Sonyango lweLaser seSemiconductor – Imodeli:TR-B
Ummiselo oLawulayo: EU MDR 2017/745
1. Ukuchongwa kwesixhobo
| Uphawu | Iinkcukacha |
| Igama lemveliso | Isixhobo sonyango lwelaser semiconductor |
| Imodeli | TR-B |
| UDI-DI | [06978556800013] |
| I-UDI-DI esisiseko | [697855680TAZ01W2] |
| Ulwahlulo | Iklasi IIb (Isixhobo Sonyango Esisebenzayo) |
| Imo yokusebenza | CW, i-single pulse, i-pulse |
| Ubude bamaza | 980nm ± 20nm (20W max); 1470nm ± 20nm (15W max); Umqadi ojongiweyo 650nm ≤ 10mW |
| Injongo Ecwangcisiweyo | Izixhobo zonyango lwelaser zeSemiconductor (Imodeli: TR-B) ziqulathe ubude obu-2 be-wavelengths: 980nm kunye ne-1470nm. Ubude be-980nm buboniswe ukuba busetyenziswe kunyango nakutyando, nto leyo enika amandla elaser kwiithishu ezifuna ukufuthwa, ukunqunyulwa, ukunqunyulwa, ukunqunyulwa, ukunqunyulwa kunye nokujiya okanye ukujiya, kwaye ifanelekile kwiingcali ezifana notyando lwe-anorectal kunye ne-gynecology. Ubude be-1470nm bujolise ekunyangeni i-saphenous vein reflux enxulumene nemithambo ye-varicose kunye ne-varicosities. |
| Imifanekiso yeMveliso |
|
2. Umenzi kunye nabameli abagunyazisiweyo
| Iqumrhu | Iinkcukacha |
| Ulwazi loMvelisi | Igama: I-Baoding Te'anzhou Electronic Technology Co., Ltd. Idilesi: Igumbi 1702, Umgangatho we-17, Isakhiwo soPhando noPhuhliso oluQhelekileyo lweTekhnoloji yeZhibo, 89 Hengbin Road, eBaoding, eHebei, eTshayina Umnxeba: +86-18331271987 Iwebhu: www.tazmedicalaser.com |
| Ummeli oGunyazisiweyo we-EU | Igama: I-MedPath Gmbh Idilesi: Mies-van-der-Rohe-Strasse 8 80807 Munich, eJamani Qhagamshelana: Zejian Yang Umnxeba:+49(0)89 81306837 |
| Ummeli oGunyazisiweyo wase-UK | Igama: I-Abmed Medical Technology Group Ltd Idilesi: 52A Westerham Road, Sevenoaks, England, TN132PZ, United Kingdom Uqhagamshelwano: Gloria Wang Umnxeba: +44 7388 038 766 |
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.
Utyando lwe-Anorectal (980nm): iintlungu, ukopha okuncinci, ukugcinwa komchamo okwethutyana, ukopha okukhulu, usulelo, ukwenzakala kwamalungu omzimba.
I-Gynecology (980nm): ukopha emva kotyando, ukopha okukhulu, ukugqobhoka.
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:
| Isixhobo sokuncedisa | Inkcazo | Imfuneko |
| Ifayibha yoKubona | Ububanzi beCore: 400μm (980nm) okanye 600μm (1470nm) | Kunyanzelekile |
| Iiglasi zoKhuseleko | Uxinano lwe-Optical (OD) ≥ 4 kwi-800–1700nm | Kunyanzelekile |
| Utshintsho lweenyawo | Isixhumi esihambelanayo nesilinganisiweyo se-IPX8 | Kubonelelwe |
| Ukusetyenziswa kwefayibha ye-optical engachazwanga njengehambelanayo kunokubangela umonakalo kwizixhobo, ukungasebenzi kakuhle kwezonyango, kwaye akuvumelekanga ngokungqongqo. | ||
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.