Xaiv qhov ntsuas kub kho mob yuav tsum tau ceev faj tshwj xeeb, xws liqhov tseeb, kev ntseeg siab, kev nyab xeeb, thiab kev ua raws caicuam tshuam ncaj qha rau tus neeg mob kev noj qab haus huv, kev kuaj mob tshwm sim, thiab kev kho mob zoo. Cov hauv qab no yog cov ntsiab lus tseem ceeb rau tsom mus rau:
I. Core Performance Metrics
1. Qhov tseeb & Precision:
- Qhov no yog qhov kev ntsuas tseem ceeb tshaj plaws.Kev ntsuas kub ntawm kev kho mob feem ntau xav tau siab heev (piv txwv li, ± 0.1 ° C lossis ± 0.05 ° C). Kev ua yuam kev ntau dhau tuaj yeem ua rau kev kuaj tsis raug lossis kev kho mob qeeb.
- Ua tib zoo saib xyuas qhov tseeb ntawm qhov ntsuas kub ntawm lub hom phiaj (piv txwv li, qhov ncauj: 35-42 ° C, ambient: 15-30 ° C).
- Nkag siab txog nws txoj kev ruaj ntseg ntev (drift) thiab rov ua dua.
2. Kev daws teeb meem:
- Qhov tsawg tshaj plaws kub hloov lub sensor tuaj yeem ntes / pom (piv txwv li, 0.01 ° C lossis 0.1 ° C). Kev daws teeb meem siab dua pab saib xyuas cov kev hloov pauv hloov maj mam, tshwj xeeb tshaj yog hauv kev saib xyuas tseem ceeb lossis kev sim ua kom meej.
3. Lub Sijhawm Teb:
- Lub sij hawm xav tau rau lub sensor kom ncav cuag qhov kub thiab txias ntawm cov khoom ntsuas (feem ntau qhia raws li lub sij hawm tas li, piv txwv li, vib nas this mus rau kaum vib nas this).
- Daim ntawv thov txiav txim siab xav tau:Lub pob ntseg ntsuas kub xav tau cov lus teb ceev heev (thib ob), thaum lub ntsuas kub tseem ceeb lossis ntsuas lub tshuab nqus tsev tuaj yeem tiv taus cov lus teb qeeb (ntaus vib nas this mus rau feeb).
4. Kev ntsuas ntau:
- Xyuas kom lub sensor qhov kub thiab txias ua hauj lwm tag nrho cov kev xav tau ntawm daim ntawv thov (piv txwv li, tus pas ntsuas kub: 35-42 ° C, cryogenic cia: -80 ° C, high-temperature sterilization: > 121 ° C).
II. Kev nyab xeeb & Biocompatibility
5. Biocompatibility (Rau kev sib cuag Sensors):
- Yog hais tias lub sensor ncaj qha mus cuag tus neeg mob daim tawv nqaij, mucous daim nyias nyias, los yog lub cev kua (xws li, qhov ncauj, qhov quav, esophageal, vascular catheter probes), nwsyuav tsumUa raws li cov txheej txheem kho mob biocompatibility (xws li ISO 10993 series).
- Cov ntaub ntawv yuav tsum tsis muaj tshuaj lom, tsis hnov tsw, tsis yog-cytotoxic, thiab tiv taus cov txheej txheem tshuaj tua kab mob/sterilization.
6. Kev Nyab Xeeb Hluav Taws Xob:
- Yuav tsumUa raws li cov qauv kev nyab xeeb kev kho mob nruj heev (piv txwv li, IEC 60601-1 thiab nws cov qauv kev pov hwm).
- Cov kev xav tseem ceeb suav nrog kev rwb thaiv tsev, cov dej ntws tawm (tshwj xeeb yog cov neeg mob siv cov khoom), kev tiv thaiv defibrillation (yog siv nyob rau hauv ib puag ncig uas defibrillation yuav tshwm sim), thiab lwm yam.
- Kev tiv thaiv hluav taws xob poob siab yog qhov tseem ceeb.
7. Disinfection / Sterilization Compatibility:
- Yuav ua li cas tshuaj tua kab mob los yog kev ua kom tsis muaj menyuam yuav tsum lub sensor lossis nws qhov kev sojntsuam tiv taus (xws li, cawv so, autoclaving, ethylene oxide (EtO) sterilization, low-temperature plasma sterilization)?
- Sensor kev ua tau zoo thiab cov khoom siv ruaj khov yuav tsum nyob ruaj khov tom qab rov ua kom tsis muaj kab mob / ua kom tsis muaj menyuam.
8. Invasiveness Risk (Rau kev sib cuag Sensors):
- Xav txog cov kev pheej hmoo cuam tshuam nrog txoj kev siv (xws li, mucosal puas, kev pheej hmoo kis kab mob) thiab xaiv cov kev sojntsuam nrog kev nyab xeeb, tsim qauv zoo.
III. Environmental Adaptability & Robustness
9. Environmental kam rau ua:
- EMI Resistance:Nyob rau hauv ib puag ncig saturated nrog cov khoom siv kho mob hluav taws xob, lub sensor yuav tsum tiv thaiv kev cuam tshuam los xyuas kom ruaj khov, raug nyeem.
- Kub / Humidity Range:Lub sensor nws tus kheej yuav tsum muaj kev ntseeg siab nyob rau hauv kev cia siab ib puag ncig.
- Chemical Resistance:Nws puas tuaj yeem tiv taus cov tshuaj tua kab mob, tshuaj tua kab mob, cov kua dej hauv lub cev, thiab lwm yam?
10. Mechanical Robustness:
- Puas yog nws muaj peev xwm tiv taus kev siv niaj hnub, tu, thiab tej zaum yuav poob los yog cuam tshuam (tshwj xeeb tshaj yog rau cov khoom siv tes tuav)?
- Puas yog cov cables (yog tias tam sim no) ruaj khov thiab cov khoom sib txuas puas ntseeg tau?
IV. Kev Tswj Xyuas Kev Ua Raws Cai & Daim Ntawv Pov Thawj
11. Cov Khoom Siv Kho Mob Kev Tswj Xyuas Cov Ntawv Pov Thawj:
- Qhov no yog qhov yuav tsum tau ua!Sensors, raws li cov cuab yeej kho mob lossis cov khoom tseem ceeb ntawm qhov ntawd, yuav tsum tau txais kev pom zoo rau kev lag luam lub hom phiaj.
- Cov ntawv pov thawj tseem ceeb suav nrog: US FDA 510 (k) lossis PMA, EU CE Marking (hauv MDR), Tuam Tshoj NMPA rau npe, thiab lwm yam.
- Xyuas kom cov neeg muab khoom muab cov ntaub ntawv pov thawj siv tau.
12. Cov Qauv Txheej Txheem Ua Raws Cai:
- Ua raws li cov txheej txheem thoob ntiaj teb thiab lub teb chaws, xws li IEC / EN 60601 series (kev nyab xeeb hluav taws xob, EMC), ISO 13485 (Kev Tswj Xyuas Zoo), ISO 80601-2-56 (Cov kev cai tshwj xeeb rau kev nyab xeeb thiab kev ua haujlwm tseem ceeb ntawm cov ntsuas kub hauv tsev kho mob), thiab lwm yam.
V. Application Scenario & Usability
13. Cov Lus Qhia Tshwj Xeeb ntawm Daim Ntawv Thov:
- Kev ntsuas qhov chaw:Lub cev nto (pem hauv ntej, axilla), lub cev kab noj hniav (qhov ncauj, qhov quav, pob ntseg kwj dej), core (esophageal, zais zis, pulmonary artery), kua (ntshav, kab lis kev cai media), ib puag ncig (incubator, tub yees, sterilizer)?
- Kev ntsuas hom:Kev soj ntsuam tas li lossis chaw kuaj xyuas? Tiv tauj lossis tsis sib cuag (infrared)?
- Kev xav tau kev koom ua ke:Standalone ntaus ntawv (piv txwv li, tus pas ntsuas kub) los yog kev koom ua ke rau hauv lwm yam khoom siv kho mob (xws li, tus neeg saib xyuas, lub tshuab tshuaj loog, lub tshuab ua pa, incubator me nyuam mos, tshuab lim ntshav)? Dab tsi yog hom interface xav tau (analog / digital)?
- Cov neeg mob:Cov neeg laus, menyuam yaus, cov menyuam yug tshiab, cov neeg mob hnyav?
14. Loj & Zoo:
- Qhov kev sojntsuam loj puas tsim nyog rau qhov chaw ntsuas (piv txwv li, qhov kev sojntsuam hauv plab yuav tsum nyias nyias)?
- Puas yog tag nrho cov sensor loj haum rau kev koom ua ke lossis siv tes tuav?
15. Kev siv & Ergonomics:
- Puas yog kev ua haujlwm yooj yim thiab intuitive? Cov zaub puas meej thiab yooj yim nyeem?
- Puas yog nws yooj yim thiab yooj yim rau cov neeg mob thiab cov neeg ua haujlwm kho mob?
16. Kho & Calibration:
- Lub sijhawm calibration yog dab tsi? Cov txheej txheem calibration nyuaj npaum li cas? Nws puas xav tau rov qab mus rau lub Hoobkas? Puas muaj cov yam ntxwv kuaj tus kheej muaj?
- Cov nqi kho mob yog dab tsi? Puas yog cov khoom siv / cov khoom seem (piv txwv li, kev sojntsuam npog) tau yooj yim thiab raug nqi?
17. Nqi:
- Xav txog tus nqi pib ntawm kev yuav khoom, nqi kho mob (calibration, hloov qhov chaw), thiab tag nrho cov nqi ntawm cov tswv cuab, thaum ua tau raws li tag nrho cov kev ua tau zoo, kev nyab xeeb, thiab kev tswj hwm.
Summary & Cov Lus Qhia
1.Definition Requirement kom meej:Ua ntej, qhia meej meej txog koj qhov kev thov tshwj xeeb ( ntsuas dab tsi, qhov twg, yuav ua li cas, qhov yuav tsum tau muaj tseeb, ib puag ncig, cov cai tswj kev lag luam, thiab lwm yam).
2.Prioritize Safety & Ua raws li: Biocompatibility, hluav taws xob kev nyab xeeb, thiab cov ntaub ntawv kho mob cov ntaub ntawv pov thawj yog tsis-negotiable liab kab.
3.Accuracy & Reliability yog qhov tseem ceeb:Txheeb xyuas qhov tseeb, ruaj khov, thiab lub sijhawm teb nyob rau hauv lub hom phiaj ntau thiab cov ntawv thov.
4.Xav txog tag nrho Lifecycle:Ntsuam xyuas kev siv tau, cov nqi kho mob (tshwj xeeb tshaj yog calibration), kev cai tshuaj tua kab mob/sterilization, thiab kav ntev.
5.Xaiv tus neeg muab kev ntseeg siab:Xaiv cov neeg muag khoom nrog cov kev paub dhau los hauv kev kho mob, lub koob npe zoo, thiab muaj peev xwm los muab kev txhawb nqa dav dav thiab cov ntaub ntawv ua raws. Nkag siab txog lawv qhov Kev Tswj Xyuas Zoo (xws li ISO 13485 tau lees paub).
6.Prototype Testing:Ua tib zoo kuaj thiab siv tau nyob rau hauv qhov tseeb daim ntawv thov ib puag ncig lossis simulated tej yam kev mob ua ntej ua tiav qhov kev xaiv.
Daim ntawv thov kev kho mob tsis muaj chaw rau kev ua yuam kev.Kev xaiv lub ntsuas kub yuav tsum ua tib zoo ntsuas tag nrho cov ntsiab lus tseem ceeb kom ntseeg tau tias nws muaj kev nyab xeeb, raug, txhim khu kev qha, thiab ua raws, yog li ua haujlwm rau kev kuaj mob thiab kev noj qab haus huv ntawm cov neeg mob. Yog tias koj muaj ib qho kev thov tshwj xeeb, kuv tuaj yeem muab cov lus qhia tshwj xeeb.
Post lub sij hawm: Lub Xya hli ntuj-29-2025