Cov khoom siv kho mob semiconductor laser
Kev Kho Mob Vein
DIODE LASER 1470nm + -20nm

Kev Kho Mob Vein

Cov Ntaub Ntawv Txog Kev Cai Lij Choj / Kev Ua Raws Cai & Kev Nyab Xeeb

Hloov Kho Tshiab Kawg: 7 Lub Xya Hli 2026

Siv tau rau: Semiconductor Laser Therapy Device - Qauv: VeinCure

Kev Tswj Xyuas: EU MDR 2017/745

1. Kev Txheeb Xyuas Cov Khoom Siv

2. Chaw Tsim Khoom & Cov Neeg Sawv Cev Tau Tso Cai

3Cov Ntaub Ntawv Txog Kev Nyab Xeeb thiab Kev Ua Tau Zoo (GSPR 23.1)

3.1 Cov Kev Tsis Txaus Siab

Nws yog contraindicated rau cov neeg mob uas muaj kab mob plawv, mob hlwb, ntshav siab lossis cov neeg uas tau ua pov thawj tias tsis haum rau kev kho mob laser.

Tsis pub siv rau ntawm lub paj hlwb hauv nruab nrab thiab lub plawv hauv nruab nrab.

Tsis pub siv lub tshuab fiber ntau optical nyob ze ntawm cov brackets lossis implants vim tias muaj kev pheej hmoo ntawm kev kub thiab kev puas tsuaj.

Kev siv cov khoom siv no yog contraindicated yog tias, raws li tus kws kho mob pom zoo, txoj kev phais mob li ntawd yog contraindicated lossis yog tias tus neeg mob tsis tuaj yeem phais lossis siv tshuaj loog vim nws tus mob feem ntau.

3.2 Cov Lus Ceeb Toom & Kev Ceev Faj

Kev Tiv Thaiv Qhov Muag: Lub cuab yeej no yog Khoom Siv Laser Qib 4. Kev tawg ncaj qha lossis tawg tuaj yeem ua rau puas tsuaj rau lub retina uas tsis tuaj yeem rov qab tau. Txhua tus neeg ua haujlwm yuav tsum hnav cov tsom iav tiv thaiv (OD ≥ 4 rau 800–1700nm) thaum lub sijhawm ua haujlwm. Qhov Nrug Deb Ntawm Qhov Muag (NOHD) yog 10.5 m.

Kev phom sij ntawm hluav taws: Tsis txhob siv ze cov tshuaj loog uas yooj yim hlawv, cov tshuaj tua kab mob uas muaj cawv, lossis lwm yam khoom siv uas yooj yim hlawv (cov ntaub thaiv qhov rais, ntawv).

Kev Nyab Xeeb Hluav Taws Xob: Xyuas kom tseeb tias muaj kev sib txuas hauv av zoo. Tsis txhob tshem lub hau; kev saib xyuas yuav tsum ua los ntawm cov neeg ua haujlwm uas tau tso cai los ntawm TAZLASER.

EMC: Tsis txhob siv ze ntawm diathermy, electrocautery, lossis cov RF emitters muaj zog. Tswj kom muaj kev sib cais deb ntawm cov khoom siv sib txuas lus RF txawb (saib IFU Seem 4.10).

Kev Siv Fiber: Tsis txhob khoov cov fiber ntau dhau (yuav tsum tswj qhov khoov tsawg kawg nkaus). Xyuas kom cov fiber txuas ruaj khov ua ntej tso tawm.

3.3 Kev Pheej Hmoo seem

Txawm hais tias muaj kev siv cov kev ntsuas kev nyab xeeb dav dav los xij, cov kev pheej hmoo uas cuam tshuam nrog kev siv lub tshuab laser Class 4 thiab cov txheej txheem phais tsis tuaj yeem tshem tawm tag nrho. Cov kev pheej hmoo seem no tau raug soj ntsuam hauv Daim Ntawv Qhia Kev Ntsuam Xyuas Kev Kho Mob (CER, Daim Ntawv No. TAZ-CE-TD11) thiab tau muab tso ua ke hauv qab no:

Kev Pheej Hmoo Tag Nrho (Siv rau txhua yam cim qhia):

Kev Raug Mob Qhov Muag: Kev siv laser ncaj qha los yog tawg ua tej daim me me tuaj yeem ua rau lub qhov muag kub hnyiab lossis dig muag uas tsis rov qab zoo li qub. (Yuav tsum tau siv cov tsom iav tiv thaiv kev nyab xeeb kom txo tau qhov mob).

Kub Hnyiab Ntawm Tawv Nqaij: Kev siv tsis raug lossis lub zog ntau dhau yuav ua rau raug mob los ntawm cua sov rau cov nqaij uas tsis yog lub hom phiaj.

Kev Phom Sij Hluav Taws: Lub zog laser yuav ua rau cov khoom siv hluav taws kub hnyiab (piv txwv li, cov ntaub thaiv qhov rais, cov tshuaj tua kab mob uas muaj cawv).

Cov Kev Pheej Hmoo Tseem Ceeb Tshwj Xeeb:

Cov leeg ntshav tawg (1470nm): Mob ntshav hlab ntshav tob (DVT), Mob ntsws txhaws, kub hnyiab ntawm daim tawv nqaij, ntshav tawm hauv cov hlab ntshav, mob ecchymosis, edema, paresthesia.

3.4 Cov Yam Ntxwv ntawm Kev Ua Tau Zoo

Kev Ua Raws Li Cov Qauv: EN IEC 60601-1, EN IEC 60601-1-2, EN IEC 60601-2-22, IEC 60825-1, IEC 62366-1.

Kev Ruaj Ntseg ntawm Cov zis: Kev sib txawv ntawm qhov tseeb thiab teeb tsa laser tso zis ≤ ± 10% (Kev Ua Haujlwm Tseem Ceeb).

Chav Kawm Laser: Chav Kawm 4 (Lub Hwj Chim Siab).

Siv Qhov: Hom B.

Kev Tiv Thaiv Ingress: IPX1 (Chav Tseem Ceeb); IPX8 (Kaw Ko Taw).

Kev Pabcuam Lub Neej: 5 xyoos (lub sijhawm ua haujlwm).

Kev Ua Haujlwm Zoo: Lub cuab yeej ua tiav cov ntaub so ntswg ablation thiab hemostasis nrog kev txo qis intraoperative los ntshav piv rau cov electrosurgery ib txwm muaj.

4Kev Tshawb Xyuas Tom Qab Kev Lag Luam & Kev Hloov Kho Tshiab Txog Kev Nyab Xeeb

Cov Ntawv Ceeb Toom Txog Kev Nyab Xeeb Hauv Thaj Chaw (FSNs):

Tam sim no tsis muaj Cov Ntawv Ceeb Toom Kev Nyab Xeeb Hauv Tebchaws rau lub cuab yeej no.

Yog tias muaj kev nqis tes kho kom zoo rau kev nyab xeeb (FSCA), ntu no yuav raug hloov kho tam sim ntawd raws li MDR Tshooj 87.

Kev Tshaj Tawm Txog Tej Xwm Txheej:

Cov neeg siv khoom raug cai yuav tsum tshaj tawm txhua qhov xwm txheej loj uas cuam tshuam nrog lub cuab yeej no rau ob tus neeg tsim khoom thiab Lub Chaw Haujlwm Muaj Peev Xwm.

Tus Neeg Tiv Tauj Chaw Tsim Khoom:lvan@tazlaser.com

Kev Sib Txuas Lus ntawm EU AR: MedPath GmbH (cov ntsiab lus saum toj no)

5Cov Khoom Siv Sib Xws

Yuav kom muaj kev nyab xeeb thiab kev ua tau zoo, tsuas yog siv cov khoom siv sib xws uas ua tau raws li cov lus qhia hauv qab no xwb:

6Tiv Tauj Yog Xav Tau Cov Lus Nug Txog Kev Cai Lij Choj

Yog xav tau kev pab txhawb nqa kev cai lij choj, cov ntaub ntawv kev siv tshuab, lossis cov ntaub ntawv ntxiv txog kev ua raws li txoj cai, thov hu rau:

Chav Haujlwm Zoo

Baoding Te'anzhou Electronic Technology Co., Ltd.

Email: lvan@tazlaser.com

Xov tooj: +86-18331271987

Lub vas sab hauv internet: www.tazmedicalaser.com

Baoding Te'anzhou Electronic Technology Co., Ltd. (TAZLASER)^© 2026). Tag nrho cov cai raug tseg cia. Cov tsos, cov khoom siv tswj hwm, thiab cov software tswj hwm raug tiv thaiv los ntawm txoj cai lij choj. Daim ntawv no lossis nws cov ntsiab lus yuav tsis raug qhia rau cov neeg thib peb lossis theej yam tsis tau kev tso cai sau ntawv. Hloov kho zaum kawg: 7 Lub Xya Hli 2026.