Adhesive -backed SpO2 Probe Fixation Pads

Peb Cov Adhesive-Backed Pulse Oxygen Probe Fixation Patch yog ib qho khoom siv kho mob tshwj xeeb uas tsim los kom ruaj ntseg thiab xis nyob ruaj ntseg pulse oximeter sojntsuam rau cov neeg mob ntiv tes, ntiv taw, lossis pob ntseg thaum saib xyuas SpO₂ tas li. Qhov no ib leeg -siv fixation thaj ua kom pom tseeb qhov chaw sojntsuam kom tau txais cov teeb liab raug thaum tiv thaiv cov khoom cuav thiab kev sojntsuam txav mus rau hauv chaw kho mob, xwm txheej ceev, thiab kev saib xyuas hauv tsev. Lub thaj ua haujlwm yog qhov tseem ceeb ntawm kev sib cuam tshuam ntawm cov sensor thiab tus neeg mob, tswj kev kho qhov muag kom zoo ib yam rau kev nyeem cov pa oxygen saturation hauv lub sijhawm saib xyuas.

Lub fixation thaj nta ib tug precision-engineered multi- txheej kev tsim kho muaj xws li kev kho mob- qib uas tsis yog- woven ntaub los yog breathable polyurethane ua npuas ncauj backing, ib tug hypoallergenic acrylic los yog silicone-raws li nplaum txheej, thiab ib tug perforated tso liner rau ib tug yooj yim daim ntawv thov. Cov txheej txheem tsim khoom siv cov txheej txheem rotary tuag-txiav thiab siab- cov thev naus laus zis lamination kom ntseeg tau tias qhov ntev (± 0.5mm kam rau ua) thiab cov nplaum nplaum txheej hnyav (feem ntau 30-50 g / m²). Cov khoom siv thaub qab yog xaiv rau kev ua pa kom zoo (MVTR> 500 g / m² / 24hr) txhawm rau tiv thaiv cov tawv nqaij maceration thaum lub sijhawm hnav ntev ntev ntawm 24-72 teev. Kev kho mob-qib daim ntawv nplaum muab kev ruaj ntseg (peel zog 1.2-2.0 N / cm) thaum ua kom tsis muaj mob, tsis muaj qhov seem, qhov tseem ceeb rau cov menyuam mos, menyuam yaus, thiab cov neeg laus uas muaj cov tawv nqaij rhiab heev. Txhua thaj yog tsim los nrog ergonomic ntiv tes zoo li contours thiab cov lus qhia muab tso rau kom haum rau ntau hom kev sojntsuam thiab cov ntiv tes loj. Kev tsim khoom tshwm sim hauv ISO Class 7 (Class 10,000) chav huv huv nrog kev tswj hwm ib puag ncig nruj rau qhov kub (18-26 degree) thiab av noo (40-60% RH) thaum lub sij hawm nplaum txheej, lamination, thiab ntim cov haujlwm. Tag nrho cov ntaub ntawv raw tau txais kev tshuaj xyuas nruj raws li USP thiab EP cov qauv tshuaj pharmacopeial, nrog rau daim ntawv pov thawj tshwj xeeb ntawm cov ntaub ntawv txheeb xyuas khaws cia hauv Cov Ntaub Ntawv Keeb Kwm (DHR) raws li xav tau los ntawm 21 CFR Tshooj 820 .

Raws li ib tug tshwj xeeb OEM / ODM chaw tsim tshuaj paus nrog vertically integrated kev khiav hauj lwm, peb tswj nruj zoo tswj nyob rau hauv tag nrho cov khoom saw los ntawm raw khoom mus rau cov khoom tiav kom tsis muaj menyuam. Peb lub chaw ua haujlwm nyob rau hauv ISO 13485: 2016 ntawv pov thawj kev tswj hwm kev tswj hwm zoo nrog kev soj ntsuam txhua xyoo kom ntseeg tau ua raws li kev cai thoob ntiaj teb. Peb tau nqis peev rau hauv cov kab ntau lawm uas muaj cov nplaum nplaum nplaum nplaum, cov tshuab tshuaj xyuas lub zeem muag, thiab muaj peev xwm ua kom tsis muaj menyuam, ua kom muaj peev xwm ntau tshaj 100 lab units txhua xyoo. Peb pab pawg kws tshaj lij tshwj xeeb hauv cov qauv tsim tshwj xeeb rau cov ntawv thov tshwj xeeb suav nrog kev saib xyuas menyuam yaus hnub nyoog qis dua, kev saib xyuas lub sijhawm ntev -, thiab cov neeg mob nyuaj uas yuav tsum tau ncua sijhawm hnav lossis txhim kho adhesion nyob rau hauv cov dej noo. Nrog rau ntau tshaj 15 xyoo ntawm kev cog lus kev tsim khoom, peb muab cov cuab yeej siv kho mob loj uas xav tau cov ntawv sau ntiag tug, kev cai ntim khoom, thiab kev tswj hwm kev txhawb nqa rau kev nkag mus rau kev lag luam thoob ntiaj teb. Peb qhov kev tswj xyuas zoo suav nrog cov txheej txheem Kho thiab Tiv Thaiv Kev Ua Haujlwm (CAPA) thiab tshaj tawm- cov txheej txheem soj ntsuam kev lag luam ua raws li FDA xav kom txhim kho tas li.

Peb Cov Adhesive-Backed Pulse Oxygen Probe Fixation Patches yog tsim los ua raws li cov qauv kev cai thoob ntiaj teb:

• TS EN ISO 13485: 2016 Daim ntawv pov thawj tag nrho rau kev tswj hwm kev kho mob zoo nrog cov peev txheej npog tsim, txhim kho, thiab tsim cov khoom siv kho mob thiab cov khoom siv kho mob
• Kev Sau Npe FDA: Chaw tso npe nrog US Food and Drug Administration; Cov khoom lag luam uas tau teev tseg hauv kev faib khoom tsim nyog (Cov Khoom Siv Cai cuam tshuam rau cov khoom siv)
• CE Marking (MDR): Muaj ntawv pov thawj raws li European Medical Device Regulation (EU) 2017/745 rau Class I kho cov cuab yeej, nrog rau cov ntaub ntawv kev tshuaj xyuas txog kev nyab xeeb thiab kev ua haujlwm.
• TS EN ISO 10993 Biocompatibility: Kev sim ua tiav dhau los rau cytotoxicity (ISO 10993-5), rhiab tawv nqaij (ISO 10993-10), thiab khaus khaus (ISO 10993-23), nrog rau daim ntawv qhia txog kev soj ntsuam lom neeg
• REACH & RoHS Raws Cai: Kev tsim cov txheej txheem tsis pub muaj cov khoom phom sij xws li phthalates, latex, thiab cov hlau hnyav; cov ntaub ntawv tshaj tawm muaj nyob rau ntawm qhov kev thov
• NMPA Daim Ntawv Pov Thawj: Siv tau Daim Ntawv Tso Cai Kho Mob Kho Mob Ntau Lawm rau Tuam Tshoj kev lag luam nkag mus rau qhov xav tau
• Sterilization Validation: EO sterilization los yog gamma irradiation validated raws li ISO 11135 los yog ISO 11137 tus qauv, nrog sterility assurance qib (SAL) ntawm 10⁻⁶
• Txee Lub neej ruaj khov: Validated 24-36 lub hlis txee lub neej nyob rau hauv kev tswj cia tej yam kev mob (10-30 degree, 20-80% txheeb ze av noo) nrog ceev ceev kev tshawb fawb kev laus ib ASTM F1980

Peb Cov Adhesive-Backed Pulse Oxygen Probe Fixation Patches sawv cev rau kev sib koom ua ke ntawm precision engineering thiab tus neeg mob-tus qauv tsim, xa cov kev ruaj ntseg fixation thiab teeb liab kev ncaj ncees uas yuav tsum tau muaj rau qhov tseeb pulse oximetry hauv ntau hom kev siv tshuaj kho mob.