Product Overview and Intended Use:
Peb Cov Neeg Laus Defibrillator Electrode Patches yog siab -kev ua tau zoo, ib zaug - siv cov cuab yeej kho mob tsim los ua qhov cuam tshuam tseem ceeb ntawm lub tshuab defibrillator lossis automated external defibrillator (AED) thiab tus neeg mob uas muaj lub plawv nres. Cov khoom ua ntej no -gelled, tus kheej- cov nplaum nplaum yog tsim los ua kom muaj sia nyob -txuag defibrillation shocks thiab synchronized cardioversion, thaum tib lub sijhawm txhawb kev saib xyuas ECG rau cov neeg laus. Lawv yog cov khoom tseem ceeb hauv chav kho mob xwm txheej ceev, tsheb thauj neeg mob, thiab pej xeem nkag mus rau AED cov kev pab cuam, qhov kev ntseeg siab thiab ceev yog qhov tseem ceeb.
Technical Specifications thiab Manufacturing txheej txheem:
Kev tsim khoom ntawm peb cov electrode thaj ua rau thaj ua rau muaj kev tshawb fawb txog cov khoom siv qib siab thiab kev tsim khoom zoo los xyuas kom meej qhov kev ua tau zoo ntawm hluav taws xob thiab kev nyab xeeb ntawm tus neeg mob.
Conductive Hydrogel Technology:Peb siv tus tswv, kho mob - qib hydrogel formulation. Cov gel no ua kom ntseeg tau tias ultra- tsis tshua muaj impedance rau kev hloov hluav taws xob zoo, tswj kev ua kom zoo dua rau ntau hom tawv nqaij (xws li diaphoretic lossis plaub hau hauv siab), thiab tsim los ua hypoallergenic kom txo cov tawv nqaij khaus. Nws cov qauv molecular tshwj xeeb lav qhov kev coj ua zoo ib yam thiab cov teeb liab pom tseeb rau kev txheeb xyuas qhov tseeb.
Component Assembly:Txhua lub ncoo muaj ntau txheej. Cov gel conductive yog laminated mus rau ib qho yooj yim, conformable ua npuas ncauj los yog tsis yog - woven backing uas tso cai rau lub ncoo mus rau ib tug ruaj khov rau lub cev contours. Ib qho nyiaj / nyiaj chloride (Ag / AgCl) coated sensor muab txoj hauv kev ruaj khov. Lub rooj sibtham muaj xws li hnyav-lub luag haujlwm, cov hlua hlau txuas ntxiv (muaj nyob rau hauv ntau qhov ntev, mus txog kev ua lag luam- ua 60 ntiv tes) nrog tus neeg mob txuas tshwj xeeb uas tsim los rau kev sib raug zoo nrog cov hom defibrillator loj (xws li Physio-Control, ZOLL, Philips, Nihon Kohden).
Ntim thiab Sterilization:Txhawm rau khaws cov gel ya raws thiab xyuas kom tsis muaj menyuam, cov khoom siv hluav taws xob tau ntim khoom siv lub siab -kev ncaj ncees tshav kub- txheej txheem sealing nyob rau hauv hermetically kaw foil hnab. Cov ntim no, ua raws li ISO 11607 cov qauv, lav cov khoom ruaj khov thiab lub neej txee yam tsawg kawg nkaus ntawm 24 txog 36 lub hlis.
Chaw tsim tshuaj paus Advantages thiab Core Competencies:
Raws li lub chaw tsim khoom tshwj xeeb ntawm cov khoom siv kho mob hluav taws xob, peb muab cov txiaj ntsig zoo sib xws hauv ntau xyoo ntawm kev paub tshwj xeeb thiab kev sib koom ua ke ntsug.
- Vertically Integrated Production: Peb cov chaw tswj hwm tag nrho cov txheej txheem tsim khoom hauv - tsev, los ntawm hydrogel formulation thiab txheej kom tuag- txiav, luam ntawv, thiab ntim khoom ntim. Qhov kawg no -mus rau-kawg tswj xyuas kom nruj batch-rau-batch sib xws, ceev prototyping, thiab yooj yooj yim kom haum raws li kev cai OEM/ODM tej yaam num, nrog rau customized connectors, cable ntev, thiab ntau hom lus ntim.
- Rigorous Quality Control: Txhua pawg tsim khoom tau nruj me ntsis hauv - txheej txheem thiab kev tshuaj xyuas zaum kawg. Peb ua cov kev ntsuam xyuas hluav taws xob impedance, kev ntsuam xyuas rov qab defibrillation (kom ntseeg tau tias ECG kev soj ntsuam muaj peev xwm tom qab- poob siab), thiab ua kom cov kev tshawb fawb txog kev laus kom paub tseeb tias kev ua tau zoo. Peb qhov kev cog lus rau kev ua tau zoo ua kom peb cov khoom siv hluav taws xob xa tawm thawj zaug - kev poob siab thaum nws tseem ceeb tshaj plaws.
Regulatory Certifications thiab Ua raws li:
Peb cov txheej txheem tsim khoom zoo thiab cov khoom lag luam ua raws li cov txheej txheem nruj tshaj plaws thoob ntiaj teb kev tswj hwm, ua kom lub ntiaj teb kev lag luam nkag mus thiab kev nyab xeeb ntawm tus neeg mob.
- Kev Tswj Xyuas Zoo: Peb cov chaw tau ntawv pov thawj rau ISO 13485: 2016, tus qauv thoob ntiaj teb rau kev tswj hwm kev kho mob zoo. Cov ntawv pov thawj no yog tswj hwm thiab tshuaj xyuas los ntawm cov thawj coj thoob ntiaj teb Cov Ntawv Ceeb Toom xws li British Standards Institution (BSI).
- Kev Nkag Mus Rau Kev Lag Luam Thoob Ntiaj Teb (MDSAP): Peb ua raws li Kev Tshawb Fawb Kev Kho Mob Ib Leeg Kev Tshawb Fawb (MDSAP), uas ua tiav cov kev cai tswj hwm ntawm ntau lub khw, suav nrog Australia, Brazil, Canada, Nyiv, thiab Tebchaws Meskas, ua kom peb lub peev xwm los pab cov neeg siv khoom thoob ntiaj teb.
- Cov Khoom Siv Kev Nyab Xeeb thiab Kev Ua Haujlwm (CE & FDA): Peb cov khoom siv hluav taws xob defibrillation yog CE cim raws li Kev Cai Kho Mob (MDR)
2017/745, ua kom pom kev ua raws li European kev noj qab haus huv, kev nyab xeeb, thiab ib puag ncig cov qauv. Rau Asmeskas kev lag luam, peb cov electrodes yog FDA- tau tso npe thiab tshem tawm, ua tau raws li qhov yuav tsum tau ua ntawm Tsoom Fwv Saib Xyuas Tshuaj. Tsis tas li ntawd, tag nrho cov ntaub ntawv raug kuaj xyuas biocompatibility raws li ISO 10993 tus qauv, kom ntseeg tau tias lawv muaj kev nyab xeeb rau kev sib cuag ntawm daim tawv nqaij.
Ordering Information thiab Customization:
Peb muaj ntau yam ntawm electrode pads, nrog rau cov neeg laus thiab cov me nyuam configurations, rau ob qho tib si kev kho mob thiab kev cob qhia daim ntaub ntawv. Peb txhawb qhov tsawg kawg nkaus txiav txim kom muaj nuj nqis (MOQs) rau kev sim cov kev pab cuam thiab scaled ntau lawm rau thoob ntiaj teb tis. Cov kev pabcuam ntiag tug muaj nyob rau txhawm rau txhim kho koj lub npe muaj nyob hauv khw.
Cim npe nrov: Tuam Tshoj tus neeg laus defibrillator electrode pads manufacturers, lwm tus neeg, Hoobkas