- Zogulitsa
- Zogulitsa Zotsimikizika ndi CE
- Laser ya Diode ya 980nm 1470nm ya Opaleshoni Yokongola
- Laser ya Diode ya 980nm 1470nm ya Phlebology ndi Opaleshoni ya Mitsempha
- Laser ya Diode ya 980nm 1470nm ya Coloproctology
- Laser ya Diode ya 980nm 1470nm ya Gynecology
- Laser ya Diode ya 980nm 1470nm ya Ent
- Laser ya Diode ya 980nm 1470nm ya Mafupa
- Laser ya Diode ya 980nm 1470nm ya Physiotherapy
- Laser ya Diode ya 980nm 1470nm ya Mano
- Laser ya Diode ya 980nm 1470nm ya Podiatry
Zipangizo zothandizira ndi laser za semiconductor
TR-B
LASER YA DIODE 980nm+-20nm
LASER YA DIODE 1470nm+-20nm
TR-B
Zambiri Zokhudza Malamulo / Kutsatira Malamulo ndi Chitetezo
Kusinthidwa Komaliza: 7 Julayi 2026
Imagwiritsidwa ntchito pa: Semiconductor Laser Therapy Device – Model: TR-B
Malamulo Oyendetsera: EU MDR 2017/745
1. Kuzindikira Chipangizo
| Khalidwe | Tsatanetsatane |
| Dzina la chinthu | Chipangizo chothandizira laser cha semiconductor |
| Chitsanzo | TR-B |
| UDI-DI | [06978556800013] |
| UDI-DI yoyambira | [697855680TAZ01W2] |
| Kugawa | Kalasi IIb (Chida Chothandizira Chogwira Ntchito) |
| Njira yogwirira ntchito | CW, kugunda kwa mtima kamodzi, kugunda kwa mtima |
| Mafunde a mafunde | 980nm ± 20nm (20W max); 1470nm ± 20nm (15W max); Mzere wolunjika 650nm ≤ 10mW |
| Cholinga Choyembekezeredwa | Zipangizo zochizira laser za Semiconductor (Model: TR-B) zili ndi ma wavelength awiri: 980nm ndi 1470nm. Kutalika kwa mafunde kwa 980nm kumagwiritsidwa ntchito pochiza ndi opaleshoni, komwe kumapereka mphamvu ya laser ku minofu yomwe ikufunika kupukutidwa, kudulidwa, kuchotsedwa, kuchotsedwa, kudulidwa ndi kutsekeka kwa magazi kapena kuviika, ndipo ndi yoyenera pazachipatala monga opaleshoni ya anorectal ndi matenda a akazi. Kutalika kwa mafunde kwa 1470nm cholinga chake ndi kuchiza matenda a mitsempha ya saphenous omwe amabwera chifukwa cha mitsempha ya varicose ndi varicosities. |
| Zithunzi Zamalonda |
|
2. Opanga & Oyimira Ovomerezeka
| Bungwe | Tsatanetsatane |
| Zambiri za Wopanga | Dzina: Baoding Te'anzhou Electronic Technology Co., Ltd. Adilesi: Chipinda 1702, Pansi pa 17, Nyumba Yofufuza ndi Chitukuko ya Zhibo Technology Comprehensive Research And Development, 89 Hengbin Road, Baoding, Hebei, China Foni: +86-18331271987 Webusaiti: www.tazmedicalaser.com |
| Woyimira Wovomerezeka wa EU | Dzina: MedPath Gmbh Adilesi: Mies-van-der-Rohe-Strasse 8 80807 Munich, Germany Contact: Zejian Yang Foni:+49(0)89 81306837 |
| Woyimira Wovomerezeka ku UK | Dzina: Abmed Medical Technology Group Ltd Adilesi: 52A Westerham Road, Sevenoaks, England, TN132PZ, United Kingdom Lumikizanani: Gloria Wang Foni: +44 7388 038 766 |
3Chidziwitso cha Chitetezo ndi Magwiridwe Antchito (GSPR 23.1)
3.1 Zoletsa
Ndi zoletsedwa kwa odwala omwe ali ndi matenda a mtima, matenda amisala, kuthamanga kwa magazi kapena omwe atsimikiziridwa kuti sakuyenera kulandira chithandizo cha laser.
Kugwiritsa ntchito pa dongosolo la mitsempha ndi dongosolo la magazi sikuloledwa.
Kugwiritsa ntchito chipangizo choyezera ulusi pafupi ndi mabulaketi kapena ma implants sikuloledwa chifukwa pali chiopsezo cha kutentha ndi kuwonongeka.
Kugwiritsa ntchito chipangizo chomwe chikukhudzidwa ndi vutoli n'koletsedwa ngati, malinga ndi maganizo a dokotala, njira yochitira opaleshoniyo ndi yoletsedwa kapena ngati wodwalayo sangathe kuchitidwa opaleshoni kapena mankhwala oletsa ululu chifukwa cha vuto lake lonse.
3.2 Machenjezo ndi Zodzitetezera
Chitetezo cha Maso: Chipangizochi ndi cha Class 4 Laser Product. Kuwala mwachindunji kapena kofalikira kumatha kuwononga retina mosalekeza. Ogwira ntchito onse ayenera kuvala zoteteza maso (OD ≥ 4 kwa 800–1700nm) panthawi yogwira ntchito. Kutalikirana ndi Zoopsa za Maso (NOHD) ndi 10.5 m.
Ngozi ya Moto: Musagwiritse ntchito mankhwala oletsa ululu omwe amayaka pafupi ndi moto, mankhwala ophera tizilombo toyambitsa matenda okhala ndi mowa, kapena zinthu zina zomwe zimayaka (machira, mapepala).
Chitetezo cha Magetsi: Onetsetsani kuti pansi pake pakhazikika bwino. Musachotse chivundikirocho; kukonza kuyenera kuchitidwa ndi ogwira ntchito ovomerezeka ndi TAZLASER.
EMC: Musagwiritse ntchito pafupi ndi diathermy, electrocautery, kapena ma RF emitter amphamvu. Sungani mtunda woyenera kuchokera ku zida zolumikizirana za RF zam'manja (onani Gawo 4.10 la IFU).
Kusamalira Ulusi: Musapindire ulusi mopitirira muyeso (ma radius ochepa opindika ayenera kusungidwa). Onetsetsani kuti ulusi walumikizidwa bwino musanatulutse ulusi.
3.3 Zoopsa Zotsala
Ngakhale kuti njira zonse zotetezera zakhazikitsidwa, zoopsa zomwe zimachitika chifukwa chogwiritsa ntchito laser ya Class 4 ndi opaleshoni sizingathetsedwe kotheratu. Zoopsa zotsalazi zawunikidwa mu Clinical Evaluation Report (CER, Document No. TAZ-CE-TD11) ndipo zafotokozedwa mwachidule pansipa:
Zoopsa Zonse Zotsalira (Zogwiritsidwa ntchito pa zizindikiro zonse):
Kuvulala kwa Maso: Kuwala kwa laser mwachindunji kapena kofalikira kungayambitse kupsa kwa retina kosatha kapena khungu. (Kuchepetsedwa ndi kugwiritsa ntchito magalasi oteteza).
Kupsa Pakhungu: Kugwiritsa ntchito molakwika kapena mphamvu zambiri kungayambitse kuvulala kwa kutentha kwa minofu yomwe siili yolunjika.
Ngozi ya Moto: Mphamvu ya laser ikhoza kuyatsa zinthu zomwe zimayaka moto (monga nsalu, mankhwala ophera tizilombo toyambitsa matenda okhala ndi mowa).
Zoopsa Zotsalira Zosonyeza Chizindikiro:
Mitsempha ya Varicose (1470nm): Deep Vein Thrombosis (DVT), Pulmonary Embolism, kutentha kwa khungu, hematoma, ecchymosis, kutupa, paresthesia.
Opaleshoni ya Anorectal (980nm): ululu, kutuluka magazi pang'ono, kusunga mkodzo kwakanthawi, kutuluka magazi kwambiri, matenda, kuvulala kwa ziwalo.
Matenda a akazi (980nm): kutuluka magazi pambuyo pa opaleshoni, kutuluka magazi ambiri, kubooka.
3.4 Makhalidwe Abwino
Kutsatira Miyezo: EN IEC 60601-1, EN IEC 60601-1-2, EN IEC 60601-2-22, IEC 60825-1, IEC 62366-1.
Kukhazikika kwa Zotuluka: Kupatuka pakati pa zotuluka zenizeni ndi zokhazikika za laser ≤ ± 10% (Kugwira Ntchito Kofunikira).
Kalasi ya Laser: Kalasi 4 (Mphamvu Yaikulu).
Gawo Logwiritsidwa Ntchito: Mtundu B.
Chitetezo cha Kulowa: IPX1 (Chigawo Chachikulu); IPX8 (Chosinthira Mapazi).
Moyo wa Utumiki: Zaka 5 (nthawi yogwira ntchito).
Kugwira Ntchito: Chipangizochi chimathandiza kuchotsa minofu yolunjika komanso kuchotsa magazi m'thupi mwa munthu pogwiritsa ntchito njira yochepetsera magazi mkati mwa opaleshoni poyerekeza ndi opaleshoni yamagetsi.
4Zosintha za Kuyang'anira ndi Chitetezo Pambuyo pa Msika
Zidziwitso za Chitetezo cha M'munda (FSNs):
Pakadali pano palibe Zidziwitso Zokhudza Chitetezo Chakumunda zomwe zikugwira ntchito pa chipangizochi.
Ngati pachitika njira yokonza chitetezo (FSCA), gawoli lidzasinthidwa nthawi yomweyo mogwirizana ndi MDR Article 87.
Kufotokoza Zochitika:
Ogwiritsa ntchito ali ndi udindo wovomerezeka mwalamulo kunena za ngozi zilizonse zazikulu zokhudzana ndi chipangizochi kwa wopanga komanso kwa Akuluakulu Oyenerera.
Lumikizanani ndi Wopanga Kuzindikira:lvan@tazlaser.com
Kulumikizana ndi EU AR: MedPath GmbH (tsatanetsatane pamwambapa)
5Zowonjezera Zogwirizana
Kuti zitsimikizire chitetezo ndi magwiridwe antchito, zowonjezera zogwirizana zokha zomwe zikukwaniritsa zofunikira izi ziyenera kugwiritsidwa ntchito:
| Chowonjezera | Kufotokozera | Chofunikira |
| Ulusi Wowala | Chimake chapakati: 400μm (980nm) kapena 600μm (1470nm) | Chovomerezeka |
| Magalasi Oteteza | Kuchuluka kwa Kuwala (OD) ≥ 4 kwa 800–1700nm | Chovomerezeka |
| Kusinthana kwa Mapazi | Cholumikizira chogwirizana ndi IPX8 | Zoperekedwa |
| Kugwiritsa ntchito ulusi wowala womwe sunatchulidwe kuti umagwirizana kungayambitse kuwonongeka kwa zida, kusagwira bwino ntchito kwa mankhwala, ndipo ndikoletsedwa mwamphamvu.. | ||
6Lumikizanani nafe kuti mudziwe zambiri zokhudza malamulo
Kuti mupeze chithandizo cha malamulo, mafayilo aukadaulo, kapena zambiri zowonjezera zokhudzana ndi kutsata malamulo, chonde lemberani:
Dipatimenti Yoyang'anira Ubwino
Baoding Te'anzhou Electronic Technology Co., Ltd.
Imelo: lvan@tazlaser.com
Foni: +86-18331271987
Webusaiti: www.tazmedicalaser.com
Baoding Te'anzhou Electronic Technology Co., Ltd. (TAZLASER)© 2026). Maufulu onse ndi otetezedwa. Mawonekedwe, makina owongolera zida, ndi mapulogalamu owongolera amatetezedwa ndi ufulu waumwini. Chikalatachi kapena zomwe zili mkati mwake sizingawululidwe kwa anthu ena kapena kukopedwa popanda chilolezo cholembedwa. Zasinthidwa komaliza: 7 Julayi 2026.