- Ibicuruzwa
- Ibicuruzwa byemejwe na CE
- Laser ya Diode ya 980nm 1470nm yo kubaga ubwiza
- Laser ya Diode ya 980nm 1470nm yo kubaga imitsi n'imitsi
- Laser ya Diode ya 980nm 1470nm yo mu bwoko bwa Coloproctology
- Laser ya Diode ya 980nm 1470nm yo mu rwego rw'abagore
- Laser ya Diode ya 980nm 1470nm yo mu bwoko bwa Ent
- Laser ya Diode ya 980nm 1470nm yo kuvura amagufwa
- Laser ya Diode ya 980nm 1470nm yo kuvura indwara z'umubiri
- Laser ya Diode ya 980nm 1470nm yo kuvura amenyo
- Laser ya Diode ya 980nm 1470nm yo kuvura indwara z'amaguru
Ibikoresho byo kuvura hakoreshejwe laser ya semiconductor
Umuti w'imitsi
DIODE LASER 1470nm+-20nm
Umuti w'imitsi
Amakuru y'amabwiriza / Iyubahirizwa ry'amategeko n'umutekano
Iheruka kuvugururwa: 7 Nyakanga 2026
Ikoreshwa kuri: Igikoresho cyo kuvura hakoreshejwe laser cya Semiconductor – Model: VeinCure
Amabwiriza agenga: EU MDR 2017/745
1. Kumenya igikoresho
| Ikiranga | Ibisobanuro birambuye |
| Izina ry'igicuruzwa | Igikoresho cyo kuvura hakoreshejwe laser ya semiconductor |
| Icyitegererezo | Umuti w'imitsi |
| UDI-DI | [06978556800006] |
| UDI-DI y'ibanze | [697855680TAZ01W2] |
| Gushyira mu byiciro | Icyiciro cya IIb (Igikoresho cy'ubuvuzi gikora) |
| Uburyo bwo gukora | CW, umuvuduko umwe, umuvuduko |
| Uburebure bw'imiraba | 1470nm ± 20nm (15W ntarengwa); Umurabyo ugana ku gipimo cya 650nm ≤ 10mW |
| Intego Igamije | Ibikoresho byo kuvura hakoreshejwe laser ya Semiconductor (Model: VeinCure) bigenewe kuvura indwara ya saphenous vein reflux ifitanye isano n'imitsi itera kuribwa mu maraso n'imitsi itera kuribwa mu maraso. |
| Amashusho y'ibicuruzwa |
|
2. Uruganda n'abahagarariye bemewe
| Ikigo | Ibisobanuro birambuye |
| Amakuru y'Uruganda | Izina: Baoding Te'anzhou Electronic Technology Co., Ltd. Aderesi: Icyumba 1702, Igorofa rya 17, Inyubako y'ubushakashatsi n'iterambere ry'ikoranabuhanga rya Zhibo, 89 Hengbin Road, Baoding, Hebei, mu Bushinwa Terefone: +86-18331271987 Urubuga: www.tazmedicalaser.com |
| Uhagarariye EU wemewe | Izina: MedPath Gmbh Aderesi: Mies-van-der-Rohe-Strasse 8 80807 Munich, Ubudage Twandikire: Zejian Yang Terefone: +49(0)89 81306837 |
| Uhagarariye mu Bwongereza wemewe | Izina: Abmed Medical Technology Group Ltd Aderesi: 52A Westerham Road, Sevenoaks, Ubwongereza, TN132PZ, Ubwongereza Umuntu wo kuvugana na we: Gloria Wang Terefone: +44 7388 038 766 |
3Amakuru y'Umutekano n'Imikorere (GSPR 23.1)
3.1 Ibibujijwe
Birabujijwe ku barwayi bafite indwara z'umutima, indwara zo mu mutwe, umuvuduko ukabije w'amaraso cyangwa abagaragaye ko badakwiye kuvurwa hakoreshejwe laser.
Gukoresha imiti mu mitsi yo hagati no mu mitsi yo hagati ntibyemewe.
Ntibyemewe gukoresha agakoresho k'icyuma gapima umucyo hafi y'udukingirizo cyangwa implants kuko hari ibyago byo gushyuha no kwangirika
Gukoresha igikoresho cy’ubuvuzi birabujijwe iyo, nk’uko umuganga uvura abitekereza, uburyo bwo kubaga nk’ubwo bubujijwe cyangwa niba umurwayi adashobora kubagwa cyangwa gusinziriza bitewe n’uburwayi bwe muri rusange.
3.2 Imiburo n'Amabwiriza yo Kwirinda
Uburinzi bw'amaso: Iki gikoresho ni igikoresho cya laser cyo mu rwego rwa 4. Imirasire itaziguye cyangwa itatanye ishobora kwangiza uruhu rw'ijisho mu buryo budasubirwaho. Abakozi bose bagomba kwambara imyenda irinda amaso (OD ≥ 4 kuri 800–1700nm) mu gihe cyo kuyikoresha. Intera y'akaga k'amaso (NOHD) ni metero 10.5.
Inkongi y'umuriro: Ntugakoreshe imiti igabanya ububabare hafi y'aho ishobora gushya, imiti yica udukoko ishingiye kuri alcool, cyangwa ibindi bikoresho bishya (udutambaro, impapuro).
Umutekano w'amashanyarazi: Menya neza ko hasi hakwiye. Ntukureho igipfundikizo; kubungabunga bigomba gukorwa n'abakozi bemewe na TAZLASER.
EMC: Ntugakoreshe hafi y'aho diathermy, electrocautery, cyangwa RF emitters zikomeye. Komeza utandukanye n'ibikoresho by'itumanaho bya RF bigendanwa (reba igice cya 4.10 cya IFU).
Gufata Fibre: Ntugapfundike fibre cyane (umurambararo muto wa fibre ugomba kubungabungwa). Menya neza ko fibre ifatanye neza mbere yo kuyisohora.
3.3 Ingaruka zisigaye
Nubwo hashyizweho ingamba zuzuye z’umutekano, ingaruka mbi ziterwa no gukoresha laser yo mu cyiciro cya 4 n’uburyo bwo kubaga ntizishobora gukurwaho burundu. Izi ngaruka zisigaye zasuzumwe muri Raporo y’Isuzuma ry’Ubuvuzi (CER, Inyandiko No. TAZ-CE-TD11) kandi zikubiye muri iyi nyandiko ikurikira:
Ingaruka Rusange z'Ibisigazwa (Bikoreshwa ku bimenyetso byose):
Gukomereka mu maso: Imirasire ya laser ishobora gutera ubushye budasubirwaho cyangwa ubuhumyi ku maso. (Igabanywa no gukoresha indorerwamo z'umutekano ku ngufu).
Ubushyuhe bw'uruhu: Gukoresha nabi cyangwa imbaraga nyinshi bishobora gutera ubushyuhe ku ngingo zitari izo zigenewe.
Inkongi y'umuriro: Ingufu za laser zishobora gutwika ibintu bishobora gushya (urugero: amashuka, imiti yica udukoko ishingiye kuri alcool).
Ingaruka zigaragara ku bisigazwa by’ibipimo:
Imitsi ya Varicose (1470nm): Deep Vein Thrombosis (DVT), Pulmonary Embolism, ubushye bw'uruhu, hematoma, ecchymosis, kubyimba, paresthesia.
3.4 Ibiranga Imikorere
Iyubahirizwa ry'Amabwiriza: EN IEC 60601-1, EN IEC 60601-1-2, EN IEC 60601-2-22, IEC 60825-1, IEC 62366-1.
Ubudahangarwa bw'umusaruro: Gutandukana hagati y'umusaruro nyawo wa laser n'uwashyizweho ≤ ± 10% (Umusaruro w'ingenzi).
Icyiciro cya Laser: Icyiciro cya 4 (Ingufu nyinshi).
Igice cyakoreshejwe: Ubwoko bwa B.
Uburinzi bw'Injira: IPX1 (Igice Gikuru); IPX8 (Guhindura Ikirenge).
Igihe cyo gukora: Imyaka 5 (igihe cyo gukora).
Ingufu: Iki gikoresho gifasha mu gukuraho ingirangingo no gufunga amaraso mu mubiri, bigatuma amaraso agabanuka mu gihe cyo kubagwa ugereranije n'uburyo busanzwe bwo kubaga hakoreshejwe amashanyarazi.
4Amakuru ajyanye n'igenzura ry'inyuma y'isoko n'umutekano
Amatangazo y'umutekano wo mu kibuga (FSNs):
Kugeza ubu nta Matangazo y'umutekano wo mu kibuga akoreshwa kuri iki gikoresho.
Mu gihe habayeho igikorwa cyo gukosora umutekano (FSCA), iki gice kizahita kivugururwa hakurikijwe ingingo ya 87 ya MDR.
Gutanga raporo ku byabaye:
Abakoresha bategetswe n'amategeko gutanga raporo ku byago bikomeye byose birebana n'iki gikoresho ku wagikoze ndetse no ku rwego rubifitiye ububasha.
Umuntu wo kuvugana n'uruganda witwa Vigilance:lvan@tazlaser.com
Umuntu wo kuvugana na EU AR: MedPath GmbH (ibisobanuro birambuye haruguru)
5Ibikoresho Bijyanye
Kugira ngo habeho umutekano n'imikorere myiza, ibikoresho bihuye n'ibi bikurikira ni byo gusa bigomba gukoreshwa:
| Ibikoresho | Ibisobanuro | Ibisabwa |
| Fibre y'urumuri | Ingano y'ibanze: 600μm (1470nm) | Itegeko |
| Amataragi y'umutekano | Ubucucike bw'urumuri (OD) ≥ 4 kuri 800–1700nm | Itegeko |
| Guhindura ibirenge | IPX8 ifite amanota, ihuza n'abandi | Byatanzwe |
| Gukoresha fibre y'urumuri itavuzwe ko ijyanye n'ibyo ikoresha bishobora kwangiza ibikoresho, bigatuma ubuvuzi butagira akamaro, kandi birabujijwe cyane. | ||
6. Hamagara kugira ngo umenye ibibazo by'amategeko agenga imikorere
Ku bufasha mu by'amategeko, dosiye za tekiniki, cyangwa andi makuru y'inyongera ku bijyanye no kubahiriza amategeko, nyamuneka hamagara:
Ishami ry'Ubuziranenge
Baoding Te'anzhou Electronic Technology Co., Ltd.
Imeri: lvan@tazlaser.com
Terefone: +86-18331271987
Urubuga: www.tazmedicalaser.com
Baoding Te'anzhou Electronic Technology Co., Ltd. (TAZLASER)© 2026). Uburenganzira bwose burasubitswe. Ishusho, sisitemu yo kugenzura ibikoresho, na porogaramu yo kugenzura birinzwe n'uburenganzira bw'umwanditsi. Iyi nyandiko cyangwa ibikubiye muri yo ntibishobora gutangazwa ku bandi bantu cyangwa ngo bikopwe nta ruhushya rwanditse. Yaherukaga kuvugururwa: 7 Nyakanga 2026.