Nosn-04 Reusable Neonatal Spo2 Sensor Matched Nrog Tus Neeg Mob Lub txaj
Yam khoom
| HOM | Reusable neonatal spo2 sensor phim nrog tus neeg mob saib xyuas hauv txaj |
| Qeb | silicone qhwv spo2 sensor\ spo2 sensor |
| Series | Narigmed® NOSN-04 |
| Zaub parameter | SPO2\PR\PI\RR |
| SpO2 ntsuas ntau yam | 35% ~ 100% |
| SpO2 ntsuas qhov tseeb | ± 2% (70% ~ 100%) |
| Kev daws teeb meem SpO2 | 1% |
| PR ntsuas ntau yam | 25 ~ 250bpm |
| PR ntsuas qhov tseeb | Ntau dua ± 2bpm thiab ± 2% |
| PR daws teeb meem | 1bpm ua |
| Anti-txoj kev ua haujlwm | SpO2 ± 3% PR ± 4bpm |
| Tsawg perfusion ua haujlwm | SPO2 ± 2%, PR ± 2bpm Yuav ua kom tsawg li PI = 0.025% nrog Narigmed qhov kev sojntsuam |
| Perfusion Index Range | 0% ~ 20% |
| PI daws teeb meem | 0.01% |
| Ua pa tus nqi | Yeem, 4-70 rpm |
| RR daws teeb meem ratio | 1rpm ua |
| Plethyamo Graphy | Bar diagram\Pulse wave |
| Hom kev siv hluav taws xob | <20mA |
| Tshawb nrhiav tawm | Yog lawm |
| Tshawb nrhiav tsis ua haujlwm | Yog lawm |
| Pib lub sij hawm tso zis | 4s |
| Probe off detection\Probe failure detection | YOG |
| Daim ntawv thov | Cov Neeg Laus / Pediatric / Neonatal |
| Fais fab mov | 5v dc ua |
| Txoj kev sib txuas lus | TTL sib txuas lus |
| Kev sib txuas lus raws tu qauv | kho tau |
| Loj | 2m |
| Daim ntawv thov | Yuav siv tau rau hauv ib lub monitor |
| Ua haujlwm kub | 0 ° C ~ 40 ° C 15% ~ 95% Cov av noo 50kPa ~ 107.4kPa |
| chaw cia khoom | -20 ° C ~ 60 ° C 15% ~ 95% Cov av noo 50kPa ~ 107.4kPa |
Qhia luv luv
Cov ntshav oxygen sojntsuam yog tsim los ua kom tau raws li cov kev xav tau tshwj xeeb ntawm cov menyuam yug tshiab, muab txoj hauv kev maj mam, tsis muaj kev cuam tshuam los saib xyuas lawv cov ntshav oxygen. Nws tau nruab nrog cov mos mos, hloov pauv tau yooj yim uas haum rau tus menyuam daim tawv nqaij, txo qhov tsis xis nyob lossis khaus khaus. Kev sojntsuam kuj tseem tsim los ua kom ruaj khov thiab yooj yim los ntxuav, kom ntseeg tau tias nws tuaj yeem ua tau raws li cov kev xav tau niaj hnub ntawm tus menyuam mos.
Tsis tas li ntawd, peb cov ntshav oxygen sojntsuam yog tsim los rau cov qauv zoo tshaj plaws thiab kev nyab xeeb. Nws yog tsim los ntawm cov ntaub ntawv kho mob qib thiab yog hypoallergenic thiab muaj kev nyab xeeb rau cov me nyuam mos cov tawv nqaij mos. Cov cuab yeej no dhau los ua qhov kev sim nruj kom ntseeg tau tias nws muaj kev ntseeg siab thiab ua haujlwm tau zoo, ua rau cov neeg siv kev ntseeg siab hauv nws lub peev xwm los muab kev nyeem ntawv raug.
Ib qho ntawm cov yam ntxwv tseem ceeb ntawm peb cov ntshav oxygen soj ntsuam yog lawv qhov tseeb thiab qhov tseeb. Ua ke nrog narigmed's ntshav oxygen thev naus laus zis, kev sojntsuam siv cov thev naus laus zis tshaj plaws los ntsuas tus menyuam cov ntshav oxygen hauv lub sijhawm, tso cai rau kev cuam tshuam raws sijhawm yog tias pom muaj teeb meem. Qhov no yog qhov tseem ceeb tshwj xeeb tshaj yog rau cov menyuam yug tshiab, vim tias lawv cov kab mob ua pa tuaj yeem ua rau muaj kev hloov pauv ntawm cov pa oxygen. Nrog peb cov ntshav oxygen probes, cov niam txiv thiab cov kws kho mob tuaj yeem muaj kev ntseeg siab rau qhov tseeb ntawm lawv qhov kev ntsuas los muab kev saib xyuas raws sij hawm thiab zoo thaum xav tau. Tshwj xeeb optimized thiab txhim kho rau kev tiv thaiv kev tawm suab thiab tsis tshua muaj perfusion ua tau zoo. Piv txwv li, nyob rau hauv random lossis tsis tu ncua txav ntawm 0-4Hz, 0-3cm, qhov tseeb ntawm pulse oximetry (SpO2) yog ± 3%, thiab qhov ntsuas qhov tseeb ntawm pulse tus nqi yog ± 4bpm. Thaum lub hypoperfusion Performance index ntau dua los yog sib npaug rau 0.025%, pulse oximetry (SpO2) raug yog ± 2%, thiab cov mem tes ntsuas qhov tseeb yog ± 2bpm.
Qhov tseem ceeb ntawm kev saib xyuas cov ntshav oxygen hauv cov menyuam yug tshiab tsis tuaj yeem hais ntau dhau. Rau cov menyuam mos, tswj kom muaj cov pa oxygen txaus yog qhov tseem ceeb rau kev txhawb nqa lawv txoj kev loj hlob thiab kev loj hlob, tshwj xeeb tshaj yog nyob rau theem pib ntawm lub neej. Peb cov ntshav oxygen probes muab cov niam txiv thiab cov kws kho mob nrog cov cuab yeej tseem ceeb los taug qab lawv tus menyuam cov pa oxygen, txheeb xyuas cov teeb meem uas yuav tshwm sim thiab muab kev cuam tshuam raws sijhawm. Txawm hais tias koj tab tom saib xyuas tus menyuam mos ntxov ntxov hauv NICU lossis saib xyuas koj tus menyuam hauv tsev, peb cov kev sojntsuam muab kev ntsuas kev ntseeg siab, raug rau kev thaj yeeb nyab xeeb.
Hauv cov ntsiab lus, peb cov ntshav oxygen soj ntsuam yog cov cuab yeej tseem ceeb hauv kev saib xyuas menyuam mos, muab qhov tseeb, kev ntseeg siab thiab siv tau yooj yim. Nws cov qauv tsim, tsis muaj kev cuam tshuam ua rau nws tsim nyog rau cov neeg mob hluas tshaj plaws, thiab nws cov kev ntsuas meej muab cov kev pom zoo los txhawb tus menyuam txoj kev noj qab haus huv thiab kev noj qab haus huv. Nrog peb cov ntshav oxygen probes, cov niam txiv thiab cov kws kho mob tuaj yeem saib xyuas lawv cov menyuam mos cov pa oxygen nrog kev ntseeg siab kom ntseeg tau tias lawv tau txais kev saib xyuas zoo tshaj plaws.
1.Koj puas yog lub Hoobkas?
Peb yog cov chaw tsim khoom ntawm ntiv tes mem tes oximeter. Peb muaj peb tus kheej daim ntawv pov thawj khoom kho mob sau npe, kev tsim cov ntawv pov thawj zoo, kev tsim patent, thiab lwm yam.
Peb muaj ntau tshaj kaum xyoo ntawm kev kawm thiab kev kho mob sib sau ua ke ntawm ICU saib. Peb cov khoom siv dav siv hauv ICU, NICU, LOSSIS, ER, thiab lwm yam.
Peb yog cov chaw tsim khoom lag luam nrog R & D, ntau lawm thiab muag khoom. Tsis tas li ntawd xwb, hauv kev lag luam oximeter, peb yog lub hauv paus ntawm ntau qhov chaw. Peb tau muab cov ntshav oxygen modules rau ntau lub npe nrov oximeter manufacturers.
(Peb tau thov rau ntau qhov kev tsim patents thiab cov khoom zoo li patents ntsig txog software algorithms.)
Tsis tas li ntawd, peb muaj qhov ua tiav ISO: 13485 kev tswj hwm, thiab peb tuaj yeem pab cov neeg siv khoom nrog rau npe khoom lag luam.
2. Koj cov ntshav cov pa oxygen puas yog?
Tau kawg, qhov tseeb yog qhov tseem ceeb uas peb yuav tsum ua kom tau raws li daim ntawv pov thawj kho mob. Peb tsis tsuas yog ua tau raws li qhov yuav tsum tau ua, tab sis peb tseem xav txog qhov tseeb hauv ntau qhov xwm txheej tshwj xeeb. Piv txwv li, kev cuam tshuam ntawm kev txav mus los, tsis muaj zog peripheral ncig, ntiv tes ntawm cov thicknesses sib txawv, ntiv tes ntawm cov tawv nqaij sib txawv xim, thiab lwm yam.
Peb qhov kev txheeb xyuas qhov tseeb muaj ntau tshaj 200 pawg ntawm cov ntaub ntawv sib piv uas npog thaj tsam ntawm 70% mus rau 100%, uas yog piv nrog cov tshuaj ntsuam xyuas cov roj ntsha ntawm tib neeg cov ntshav.
Kev txheeb xyuas qhov tseeb hauv lub xeev kev tawm dag zog yog siv cov cuab yeej tawm dag zog rau kev tawm dag zog nrog qee qhov zaus thiab qhov loj ntawm tapping, kev sib txhuam, kev txav tsis sib xws, thiab lwm yam. analyzer rau arterial ntshav Validation, nws yuav pab tau rau qee cov neeg mob xws li cov neeg mob Parkinson tus kab mob los ntsuas kev siv. Xws li kev tiv thaiv kev tawm dag zog tam sim no tsuas yog ua los ntawm peb lub tuam txhab Asmeskas hauv kev lag luam, masimo, nellcor, Philips, thiab tsuas yog peb tsev neeg tau ua qhov kev pov thawj no nrog ntiv tes oximeters.
3. Vim li cas cov ntshav oxygen hloov pauv nce thiab nqis?
Ntev npaum li cov ntshav oxygen hloov pauv ntawm 96% thiab 100%, nws nyob hauv qhov qub. Feem ntau, cov ntshav oxygen tus nqi yuav nyob ruaj khov txawm tias ua pa hauv lub xeev ntsiag to. Kev hloov pauv ntawm ib lossis ob qhov txiaj ntsig hauv ib qho me me yog qhov qub.
Txawm li cas los xij, yog tias tib neeg txhais tes muaj kev txav los yog lwm yam kev cuam tshuam thiab kev hloov hauv kev ua pa, nws yuav ua rau muaj kev hloov pauv loj hauv cov ntshav oxygen. Yog li ntawd, peb xav kom cov neeg siv nyob ntsiag to thaum ntsuas ntshav oxygen.
4. 4S ceev tso zis tus nqi, puas yog tus nqi tiag?
Tsis muaj qhov chaw xws li "tus nqi tsim" thiab "tus nqi ruaj khov" hauv peb cov ntshav oxygen algorithm. Tag nrho cov txiaj ntsig tau tshwm sim yog nyob ntawm lub cev qauv sau thiab tshuaj xyuas. 4S ceev tus nqi tso zis yog raws li kev txheeb xyuas sai thiab ua tiav ntawm cov cim mem tes ntes hauv 4S. Qhov no yuav tsum muaj ntau cov ntaub ntawv kho mob sib sau thiab kev tshuaj xyuas algorithm kom ua tiav qhov tseeb.
Txawm li cas los xij, qhov chaw rau 4S tus nqi tawm sai sai yog tias tus neeg siv tseem. Yog tias muaj kev txav mus los thaum lub xov tooj qhib, lub algorithm yuav txiav txim siab qhov kev ntseeg tau ntawm cov ntaub ntawv raws li cov ntaub ntawv sib sau ua ke thiab xaiv ncua lub sijhawm ntsuas.
5. Nws puas txhawb OEM thiab kev hloov kho?
Peb tuaj yeem txhawb OEM thiab customization.
Txawm li cas los xij, txij li lub logo npo luam ntawv yuav tsum muaj qhov sib cais ntawm lub vijtsam luam ntawv thiab cov khoom sib cais thiab kev tswj hwm bom, qhov no yuav ua rau muaj kev nce nqi ntawm peb cov khoom thiab kev tswj tus nqi, yog li peb yuav muaj qhov tsawg kawg nkaus kom muaj nuj nqis. MOQ: 1K
Lub logos peb tuaj yeem muab tau tuaj yeem tshwm sim ntawm cov khoom ntim khoom, phau ntawv qhia, thiab lub lens logos.
6. Nws puas tuaj yeem xa tawm?
Peb tam sim no muaj lus Askiv versions ntawm ntim, phau ntawv qhia thiab cov khoom sib cuam tshuam. Thiab nws tau txais ntawv pov thawj kho mob los ntawm European Union CE (MDR) thiab FDA, uas tuaj yeem txhawb kev muag khoom thoob ntiaj teb.
Tib lub sijhawm peb kuj muaj FSC daim ntawv pov thawj muag dawb (Tuam Tshoj thiab EU)
Txawm li cas los xij, rau qee lub tebchaws tshwj xeeb, nws yuav tsum nkag siab txog cov kev cai nkag hauv zos, thiab qee lub tebchaws kuj xav tau daim ntawv tso cai cais.
Lub teb chaws twg koj xa mus rau? Cia kuv lees paub nrog lub tuam txhab seb lub teb chaws puas muaj kev cai tshwj xeeb.
7. Puas muaj peev xwm txhawb kev sau npe hauv XX lub teb chaws?
Qee lub tebchaws xav tau kev tso npe ntxiv rau cov neeg sawv cev. Yog tias tus neeg sawv cev xav sau npe rau peb cov khoom hauv lub tebchaws, koj tuaj yeem nug tus neeg sawv cev kom paub meej tias lawv xav tau cov ntaub ntawv dab tsi los ntawm peb. Peb tuaj yeem txhawb muab cov ntaub ntawv hauv qab no:
510K tso cai daim ntawv pov thawj
CE (MDR) daim ntawv tso cai
ISO13485 daim ntawv pov thawj kev tsim nyog
Cov ntaub ntawv khoom
Raws li qhov xwm txheej, cov ntaub ntawv hauv qab no tuaj yeem xaiv tau (yuav tsum tau pom zoo los ntawm tus neeg muag khoom):
General Safety Inspection Report for Medical Devices
Electromagnetic compatibility test report
Biocompatibility test report
Cov khoom lag luam soj ntsuam
8. Koj puas muaj daim ntawv pov thawj kho mob?
Peb tau ua tiav cov khoom siv kho mob hauv tsev thiab ntawv pov thawj, FDA's 510K ntawv pov thawj, CE daim ntawv pov thawj (MDR), thiab ISO13485 ntawv pov thawj.
Ntawm lawv, peb tau txais daim ntawv pov thawj CE (CE0123) los ntawm TUV Süd (SUD), thiab nws tau lees paub raws li MDR cov cai tshiab. Tam sim no, peb yog thawj lub tsev tsim khoom ntawm ntiv tes clip oximeter.
Hais txog kev tsim khoom zoo, peb muaj daim ntawv pov thawj ISO13485 thiab daim ntawv tso cai tsim khoom hauv tsev.
Tsis tas li ntawd peb muaj Daim Ntawv Pov Thawj Muag Khoom Dawb (FSC)
9. Puas muaj peev xwm ua tus neeg sawv cev tshwj xeeb hauv cheeb tsam?
Lub koom haum tshwj xeeb tuaj yeem txhawb nqa, tab sis peb yuav tsum muab koj cov cai tshwj xeeb rau lub koom haum tom qab thov rau lub tuam txhab kom pom zoo raws li koj lub tuam txhab kev ua haujlwm thiab kev muag khoom muag.
Feem ntau nws yog ib lub teb chaws uas qee tus neeg sawv cev loj muaj lub zog hauv zos thiab kev sib koom ua lag luam, thiab lawv txaus siab los txhawb peb cov khoom, yog li lawv tuaj yeem koom tes.
10. Puas yog koj cov khoom tshiab? Nws tau muag ntev npaum li cas?
Peb cov khoom yog tshiab thiab tau nyob rau hauv kev ua lag luam rau ob peb lub hlis. Lawv tsuas yog tsim thiab muab tso rau hauv cov khoom siv high-end. Peb tam sim no muaj tsawg tus neeg siv khoom rau OEM kev muag khoom. Vim tias daim ntawv pov thawj sau npe, nws tsis tau nkag mus rau FDA thiab CE kev lag luam. Nws yuav raug muag hauv North America thiab European Union tom qab tau txais daim ntawv pov thawj rau npe rau lub Kaum Ib Hlis.
11. Koj cov khoom puas tau muag ua ntej? Kev tshuaj xyuas yog dab tsi?
Txawm hais tias peb cov khoom yog cov khoom tshiab, kaum tawm txhiab tus ntawm lawv tau raug xa tawm kom deb li deb, thiab cov khoom lag luam ruaj khov. Peb tau ua oximeter rau ntau tshaj kaum xyoo, thiab peb paub txog cov neeg siv khoom tawm tswv yim teeb meem. Peb tau ua tsis tiav hom kev tsom xam (DFMEA / PFMEA) rau txhua qhov tsis xws luag, los ntawm cov khoom tsim thiab kev tsim kho, kev tsim khoom, kev tswj xyuas cov khoom zoo, kev tshuaj xyuas cov khoom, ntim tswj qhov zoo ntawm tag nrho cov txheej txheem, xws li kev xa khoom, kom tsis txhob muaj kev pheej hmoo.
Tsis tas li ntawd, peb cov khoom tsim muaj nws tus kheej cov yam ntxwv, yog rhiab heev, thiab cov neeg siv khoom ntsuam xyuas yog siab heev.
12. Koj cov khoom puas yog tus qauv ntiag tug? Puas muaj kev pheej hmoo ntawm kev ua txhaum cai?
Nov yog peb tus qauv ntiag tug, thiab peb tau thov rau peb cov khoom zoo li patents thiab invention patents ntsig txog software algorithms.
Peb lub tuam txhab muaj ib tus neeg mob siab rau lub luag haujlwm rau kev tiv thaiv cov khoom lag luam kev txawj ntse. Peb tau ua tiav kev soj ntsuam tag nrho ntawm cov cuab yeej cuab tam kev txawj ntse rau peb cov khoom, thiab tib lub sij hawm ua ib qho kev teeb tsa rau kev tiv thaiv kev txawj ntse ntawm peb cov khoom thiab thev naus laus zis.
