- Imikhiqizo
- Imikhiqizo Eqinisekiswe yi-CE
- I-Diode Laser engu-980nm engu-1470nm yokuhlinzwa kobuhle
- I-Diode Laser engu-980nm engu-1470nm ye-Phlebology kanye nokuhlinzwa kwemithambo yegazi
- I-Diode Laser engu-980nm engu-1470nm ye-Coloproctology
- I-Diode Laser engu-980nm engu-1470nm ye-Gynecology
- I-Diode Laser engu-980nm 1470nm ye-Ent
- I-Diode Laser engu-980nm engu-1470nm ye-Orthopedics
- I-Diode Laser engu-980nm engu-1470nm ye-Physiotherapy
- I-Diode Laser engu-980nm 1470nm yokwelapha amazinyo
- I-Diode Laser engu-980nm 1470nm ye-Podiatry
Amadivayisi okwelapha nge-laser ye-semiconductor
TR-B
I-DIODE LASER 980nm+-20nm
I-DIODE LASER 1470nm+-20nm
TR-B
Ulwazi Lokulawula / Ukuthobela Nokuphepha
Kugcine ukubuyekezwa: 7 Julayi 2026
Kusebenza ku: Idivayisi Yokwelapha Nge-Laser Semiconductor – Imodeli: TR-B
Umthetho Olawulayo: I-EU MDR 2017/745
1. Ukuhlonza Idivayisi
| Isici | Imininingwane |
| Igama lomkhiqizo | Idivayisi yokwelapha nge-laser ye-semiconductor |
| Imodeli | TR-B |
| UDI-DI | [06978556800013] |
| I-UDI-DI eyisisekelo | [697855680TAZ01W2] |
| Ukuhlukaniswa | Isigaba IIb (Idivayisi Yokwelapha Esebenzayo) |
| Imodi yokusebenza | I-CW, i-pulse eyodwa, i-pulse |
| Ubude bamagagasi | 980nm ± 20nm (20W max); 1470nm ± 20nm (15W max); Ugongolo oluqondisiwe 650nm ≤ 10mW |
| Inhloso Ehlosiwe | Amadivayisi okwelapha nge-laser e-Semiconductor (Imodeli: TR-B) aqukethe amaza ama-wavelength amabili: 980nm kanye no-1470nm. Ubude be-wavelength obungu-980nm buboniswa ukuthi busetshenziswe ekwelapheni nasekuhlinzeni, okunikeza amandla e-laser ekuqondiseni izicubu ezidinga ukushiswa, ukunqunywa, ukunqunywa, ukuqedwa, ukunqunywa kanye nokuvaleka noma ukujiya, futhi kufanelekile ezintweni ezikhethekile njengokuhlinzwa kwe-anorectal kanye ne-gynecology. Ubude be-wavelength obungu-1470nm buhloselwe ukwelapha i-saphenous vein reflux ehlotshaniswa nemithambo ye-varicose kanye ne-varicosities. |
| Izithombe Zomkhiqizo |
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2. Umkhiqizi kanye nabameleli abagunyaziwe
| Inhlangano | Imininingwane |
| Ulwazi Lomkhiqizi | Igama: I-Baoding Te'anzhou Electronic Technology Co., Ltd. Ikheli: Igumbi 1702, Isitezi se-17, Isakhiwo Socwaningo Nokuthuthukiswa Okuphelele Kwezobuchwepheshe iZhibo, 89 Hengbin Road, eBaoding, eHebei, eShayina Ucingo: +86-18331271987 Iwebhu: www.tazmedicalaser.com |
| Ummeleli Ogunyaziwe we-EU | Igama: I-MedPath Gmbh Ikheli: Mies-van-der-Rohe-Strasse 8 80807 Munich, eJalimane Oxhumana naye: Zejian Yang Ucingo:+49(0)89 81306837 |
| Ummeleli Ogunyaziwe wase-UK | Igama: I-Abmed Medical Technology Group Ltd Ikheli: 52A Westerham Road, Sevenoaks, England, TN132PZ, United Kingdom Xhumana: uGloria Wang Ucingo: +44 7388 038 766 |
3Ulwazi Lokuphepha Nokusebenza (GSPR 23.1)
3.1 Izimo ezingahambisani nazo
Akuvunyelwe ezigulini ezinesifo senhliziyo, isifo sengqondo, umfutho wegazi ophakeme noma okuye kwafakazelwa ukuthi akufanelekile ukwelashwa nge-laser.
Ukusetshenziswa ohlelweni lwezinzwa oluphakathi kanye nohlelo lokujikeleza kwegazi oluphakathi akuvunyelwe.
Akuvunyelwe ukusebenzisa i-optical fiber probe eduze kwama-bracket noma ama-implant ngoba kukhona ingozi yokushisa nokubhujiswa.
Ukusetshenziswa kwedivayisi okukhulunywa ngayo kuyaphikiswa uma, ngokombono kadokotela olaphayo, indlela yokuhlinzwa enjalo iphikiswa noma uma isiguli singakwazi ukuhlinzwa noma ukubulala izinzwa ngenxa yesimo saso esijwayelekile.
3.2 Izexwayiso Nezinyathelo Zokuqapha
Ukuvikelwa Kwamehlo: Le divayisi iwumkhiqizo we-Laser we-Class 4. Imisebe eqondile noma esakazekile ingabangela umonakalo ongenakulungiseka we-retina. Bonke abasebenzi kumele bagqoke izibuko zokuvikela amehlo (OD ≥ 4 ngebanga elingu-800–1700nm) ngesikhathi sokusebenza. Ibanga Elingalindelekile Lengozi Yamehlo (NOHD) lingu-10.5 m.
Ingozi Yomlilo: Ungasebenzisi izibulala-zinhlungu eziseduze nokusha, izibulala-zinhlungu ezisekelwe kotshwala, noma ezinye izinto ezivuthayo (ama-drapes, iphepha).
Ukuphepha Kukagesi: Qinisekisa ukuthi isisekelo sibekwe kahle. Ungasusi isembozo; ukulungiswa kumele kwenziwe ngabasebenzi abagunyaziwe yi-TAZLASER.
I-EMC: Ungasebenzisi eduze kwe-diathermy, i-electrocautery, noma ama-RF emitter aqinile. Gcina ibanga elinconywayo lokuhlukaniswa nemishini yokuxhumana ye-RF yeselula (bheka i-IFU Section 4.10).
Ukuphathwa Kwefayibha: Ungagobi kakhulu ifayibha (kumelwe kugcinwe irediyasi encane yokugoba). Qinisekisa ukuthi ifayibha ixhunywe ngokuphephile ngaphambi kokukhipha.
3.3 Izingozi Ezisele
Naphezu kokusetshenziswa kwezinyathelo zokuphepha eziphelele, izingozi ezihambisana nokusetshenziswa kwe-laser ye-Class 4 kanye nezinqubo zokuhlinzwa azikwazi ukususwa ngokuphelele. Lezi zingozi ezisele zihlolwe ku-Clinical Evaluation Report (CER, Document No. TAZ-CE-TD11) futhi zifingqiwe ngezansi:
Izingozi Ezijwayelekile Zensalela (Kusebenza kuzo zonke izinkomba):
Ukulimala Kwamehlo: Imisebe ye-laser eqondile noma esakazekile ingabangela ukusha okungenakuguqulwa noma ubumpumputhe be-retinal. (Kuncishiswa ukusetshenziswa okuphoqelekile kwezibuko zokuphepha).
Ukusha Kwesikhumba: Ukusetshenziswa kabi noma ukuminyana kwamandla ngokweqile kungabangela ukulimala kokushisa kwezicubu ezingezona eziqondiwe.
Ingozi Yomlilo: Amandla e-laser angase avuthele izinto ezivuthayo (isb., amakhethini, izibulala-magciwane ezisekelwe ku-alcohol).
Izingozi Ezisele Eziqondile Zenkomba:
Imithambo Ye-Varicose (1470nm): I-Deep Vein Thrombosis (DVT), I-Pulmonary Embolism, ukusha kwesikhumba, i-hematoma, i-ecchymosis, i-edema, i-paresthesia.
Ukuhlinzwa Kwe-Anorectal (980nm): ubuhlungu, ukopha okuncane, ukugcinwa komchamo okwesikhashana, ukopha okukhulu, ukutheleleka, ukulimala kwezitho zomzimba.
I-Gynecology (980nm): ukopha ngemva kokuhlinzwa, ukopha okukhulu, ukubhoboka.
3.4 Izici Zokusebenza
Ukuthobela Izindinganiso: EN IEC 60601-1, EN IEC 60601-1-2, EN IEC 60601-2-22, IEC 60825-1, IEC 62366-1.
Ukuzinza Kokukhipha: Ukuphambuka phakathi kokukhipha kwe-laser kwangempela nokusethiwe ≤ ±10% (Ukusebenza Okubalulekile).
Ikilasi Le-Laser: Ikilasi 4 (Amandla Aphezulu).
Ingxenye Esetshenzisiwe: Uhlobo B.
Ukuvikelwa Kokungena: IPX1 (Iyunithi Eyinhloko); IPX8 (Ukushintsha Kwezinyawo).
Impilo Yesevisi: Iminyaka emi-5 (isikhathi sokusebenza).
Ukusebenza Kahle: Le divayisi ifinyelela ekususweni kwezicubu okuqondiwe kanye nokususwa kwegazi ngokunciphisa ukopha ngesikhathi sokuhlinzwa uma kuqhathaniswa nokuhlinzwa okuvamile kwe-electrosurgery.
4Ukuqapha Nokuphepha Kwangemva Kwemakethe
Izaziso Zokuphepha Kwensimu (ama-FSN):
Okwamanje azikho izaziso zokuphepha kwensimu ezisebenzayo zale divayisi.
Uma kwenzeka isenzo sokulungisa ukuphepha (i-FSCA), lesi sigaba sizobuyekezwa ngokushesha ngokuhambisana ne-MDR Article 87.
Ukubika Izehlakalo:
Abasebenzisi baphoqelekile ngokomthetho ukubika noma yiziphi izehlakalo ezinkulu ezihilela le divayisi kumenzi kanye neGunya Elifanele.
Xhumana nomkhiqizi we-Vigilance:lvan@tazlaser.com
Oxhumana naye we-EU AR: MedPath GmbH (imininingwane engenhla)
5Izesekeli Ezihambisanayo
Ukuqinisekisa ukuphepha nokusebenza, izesekeli ezihambisanayo kuphela ezihlangabezana nezimfuneko ezilandelayo kufanele zisetshenziswe:
| Isesekeli | Imininingwane | Isidingo |
| I-Optical Fiber | Ububanzi be-Core: 400μm (980nm) noma 600μm (1470nm) | Okuphoqelekile |
| Ama-Goggles Okuphepha | Ubuningi Bokukhanya (OD) ≥ 4 ku-800–1700nm | Okuphoqelekile |
| Ukushintsha Unyawo | Isixhumi esilinganiselwe se-IPX8, esihambisanayo | Kunikeziwe |
| Ukusetshenziswa kwe-optical fiber okungachazwanga njengokuhambisanayo kungabangela umonakalo wemishini, ukungasebenzi kahle kwezokwelapha, futhi akuvunyelwe ngokuphelele.. | ||
6Xhumana Nabo Ngemibuzo Yokulawula
Ukuze uthole ukwesekwa kwemithetho, amafayela obuchwepheshe, noma ulwazi olwengeziwe lokuthobela imithetho, sicela uxhumane:
UMnyango Wekhwalithi
I-Baoding Te'anzhou Electronic Technology Co., Ltd.
I-imeyili: lvan@tazlaser.com
Ucingo: +86-18331271987
Iwebhu: www.tazmedicalaser.com
I-Baoding Te'anzhou Electronic Technology Co., Ltd. (TAZLASER)© 2026). Wonke amalungelo agodliwe. Ukubukeka, uhlelo lokulawula ihadiwe, kanye nesofthiwe yokulawula zivikelwe yi-copyright. Lo mbhalo noma okuqukethwe kwawo akumele kudalulwe kubantu besithathu noma kukopishwe ngaphandle kwemvume ebhaliwe ecacile. Kubuyekezwe okokugcina: 7 Julayi 2026.