Iingqwalasela eziphambili zokuKhetha iiSensors zoBubushushu bezoNyango

Ukukhetha izinzwa zobushushu bezonyango kufuna isilumkiso esikhethekileyo, njengokoukuchaneka, ukuthembeka, ukhuseleko, kunye nokuthotyelwaichaphazela ngqo impilo yesigulane, iziphumo zokuxilonga, kunye nokusebenza kakuhle kwonyango. Oku kulandelayo ngamanqaku abalulekileyo ekufuneka kugxilwe kuwo:

I. Iimetriki zokuSebenza ezingundoqo

1. Ukuchaneka nokuchaneka:

• Le yeyona metric ibaluleke kakhulu.Imilinganiselo yobushushu bezonyango isoloko ifuna ukuchaneka okuphezulu kakhulu (umzekelo, ±0.1°C okanye nokuba ±0.05°C). Impazamo egqithisileyo inokukhokelela ekuxilongeni kakubi okanye ukulibaziseka unyango.
• Nika ingqalelo ukuchaneka kwenzwa ngaphakathi kwendawo yokushisa ekujoliswe kuyo (umzekelo, ngomlomo: 35-42 ° C, i-ambient: 15-30 ° C).
• Qonda ukuzinza kwayo kwexesha elide (ukukhukuliseka) kunye nokuphindaphinda.

2. Isigqibo:

• Olona tshintsho luncinci lobushushu inzwa luyakwazi ukubona / lubonise (umzekelo, 0.01 ° C okanye 0.1 ° C). Isisombululo esiphezulu sincedisa ekubekeni iliso utshintsho olufihlakeleyo, ngakumbi kukhathalelo olubalulekileyo okanye imifuniselo echanekileyo.

3. Ixesha lokuPhendula:

• Ixesha elifunekayo ukuze inzwa ifikelele kubushushu bokwenyani bento elinganisiweyo (idla ngokubonakaliswa njengexesha elingaguqukiyo, umzekelo, imizuzwana ukuya kumashumi emizuzwana).
• Isicelo simisela imfuneko:Iithemometha zendlebe zifuna impendulo ekhawulezayo kakhulu (imizuzwana), ngelixa iqondo lokushisa elingundoqo okanye imilinganiselo ye-incubator inokunyamezela ukuphendula okucothayo (amashumi emizuzwana ukuya kwimizuzu).

4. Uluhlu loMlinganiso:

• Qinisekisa ukuba iqondo lobushushu bokusebenza kwenzwa ligubungela ngokupheleleyo iimfuno zesicelo esicetyiweyo (umzekelo, ithermometers: 35-42 ° C, ugcino cryogenic: -80 ° C, inzala ephezulu yobushushu: > 121 ° C).

II. Ukhuseleko kunye nokuhambelana kwe-Biocompatibility

5. I-Biocompatibility (Kwi-Sensors zoQhagamshelwano):

• Ukuba inzwa inxibelelana ngokuthe ngqo nolusu lwesigulana, i-mucous membranes, okanye ulwelo lomzimba (umzekelo, umlomo, i-rectal, i-esophageal, i-vascular catheter probes),kufunekaukuthobela imigangatho efanelekileyo yezixhobo zonyango ze-biocompatibility (umzekelo, uthotho lwe-ISO 10993).
• Iimathiriyeli kufuneka zingabi yityhefu, zingavezi, zingabi yi-cytotoxic, kwaye zimelane neenkqubo zokubulala iintsholongwane/iintsholongwane.

6. Ukhuseleko loMbane:

• Kufunekaukuthobela imigangatho engqongqo yokhuseleko lombane yonyango (umzekelo, IEC 60601-1 kunye nemigangatho yayo yesibambiso).
• Iingqwalasela eziphambili zibandakanya ukugquma, ukuvuza kwamanzi (ingakumbi iinxalenye ezifakwe kwisigulane), ukukhuselwa kwe-defibrillation (ukuba isetyenziswe kwiindawo apho i-defibrillation inokuthi yenzeke), njl.
• Ukuthintela imingcipheko yokothuka kombane kubaluleke kakhulu.

7. Ukubulala iintsholongwane/ Ukuhambelana nokuSebenza:

• Zeziphi iindlela zokubulala iintsholongwane okanye zokuvala iintsholongwane ekufuneka isivamvo okanye iprobe yayo imelane (umzekelo, ukosula utywala, ukuvala iintsholongwane, i-ethylene oxide (EtO) inzala, ubushushu obuphantsi kobushushu beplasma)?
• Ukusebenza kwenzwa kunye nokuthembeka kwezinto kufuneka kuhlale kuzinzile emva komjikelo wokubulala iintsholongwane/ukubulala iintsholongwane ngokuphindaphindiweyo.

8. Umngcipheko wokuHlaziya (Ukufumana iiSensors zoQhagamshelwano):

• Qwalasela imingcipheko enxulumene nendlela yokusetyenziswa (umzekelo, umonakalo we-mucosal, umngcipheko wosulelo) kwaye ukhethe iiprobes ezinokhuseleko, ulungelelwaniso oluyilwe kakuhle.

III. Ukuziqhelanisa nokusiNgqongileyo kunye nokomelela

9. Ukunyamezela indalo esingqongileyo:

• Uchaso lwe-EMI:Kwiindawo ezigcwele izixhobo ze-elektroniki zonyango, inzwa kufuneka ixhathise ukuphazamiseka ukuze kuqinisekiswe ukufundwa okuzinzile, okuchanekileyo.
• Iqondo lobushushu/Uluhlu lokufuma:Inzwa ngokwayo kufuneka isebenze ngokuthembekileyo ngaphakathi kweemeko ezilindelekileyo zokusingqongileyo.
• Ukumelana neMichiza:Ngaba inokumelana nokuvezwa kwizibulali ntsholongwane, iiarhente zokucoca, ulwelo lomzimba, njl.njl.?

10. Ukomelela koomatshini:

• Ngaba iqinile ngokwaneleyo ukunyamezela ukusetyenziswa kwesiqhelo, ukucocwa, kunye nokuwa okunokwenzeka okanye iimpembelelo (ingakumbi kwizixhobo eziphathwa ngesandla)?
• Ngaba iintambo (ukuba zikhona) ziyahlala kwaye izihlanganisi zithembekile?

IV. Ukuthotyelwa koLawulo kunye neSiqinisekiso

11. Isiqinisekiso soLawulo lweSixhobo sezoNyango:

• Le yimfuneko enyanzelekileyo!Ii-Sensors, njengezixhobo zonyango okanye amacandelo abalulekileyo kuzo, kufuneka zifumane imvume yolawulo kwimarike ekujoliswe kuyo.
• Iziqinisekiso ezinkulu ziquka: I-US FDA 510 (k) okanye i-PMA, i-EU CE yokuMakisha (phantsi kwe-MDR), ukubhaliswa kwe-NMPA yase-China, njl.
• Qinisekisa ukuba ababoneleli banikezela ngamaxwebhu esiqinisekiso esisebenzayo.

12. Ukuthotyelwa kweMigangatho eFanelekileyo:

• Ukuthotyelwa kwemigangatho efanelekileyo yamazwe ngamazwe kunye nelizwe, njenge-IEC / EN 60601 series (ukhuseleko lombane, i-EMC), i-ISO 13485 (iNkqubo yoLawulo loMgangatho), ISO 80601-2-56 (Iimfuno ezikhethekileyo zokhuseleko olusisiseko kunye nokusebenza okubalulekileyo kwee-thermometers zeklinikhi), njl.

V. Imeko yeSicelo & nokuSetyenziswa

13. IiMfuno eziZodwa zeSicelo:

• Indawo yoMlinganiso:Umphezulu womzimba (ibunzi, i-axilla), umngxuma womzimba (umlomo, i-rectal, umjelo wendlebe), umbindi (umdombo, isinyi, umthambo we-pulmonary), ulwelo (igazi, imidiya yenkcubeko), okusingqongileyo (i-incubator, ifriji, isibulala-ntsholongwane)?
• Imo yomlinganiselo:Ukubeka iliso rhoqo okanye ukujonga indawo? Uqhagamshelwano okanye ukungaqhagamshelwa (i-infrared)?
• Udibaniso lweeMfuno:Isixhobo esizimeleyo (umzekelo, ithemometha) okanye ukudityaniswa kwezinye izixhobo zonyango (umz., ukubeka iliso kwesigulane, umatshini wokuthomalalisa iintlungu, umatshini wokuphefumla, incubator yosana, umatshini wokucofa igazi)? Loluphi uhlobo lojongano olufunekayo (i-analog/digital)?
• Abemi bezigulane:Abantu abadala, abantwana, abantwana abasandul’ ukuzala, abaguli abagula kakhulu?

14. Ubungakanani kunye noBume:

• Ingaba ubungakanani beprobe bufanelekile kwisiza somlinganiselo (umzekelo, iiprobe ze-neonatal rectal kufuneka zibe zincinci kakhulu)?
• Ngaba ubungakanani boluvo lulonke lufanelekile ukudityaniswa okanye ukusetyenziswa ngesandla?

15. Ukusebenziseka kunye ne-Ergonomics:

• Ngaba ukusebenza kulula kwaye kulula? Ngaba umboniso ucacile kwaye kulula ukufundeka?
• Ngaba ikhululekile kwaye ilungele zombini izigulana kunye nabasebenzi bezempilo?

16. Ugcino kunye noLungiso:

• Yintoni ikhefu lokulinganisa? Intsonkothe kangakanani inkqubo yokulinganisa? Ngaba ifuna ukubuyela kumzi-mveliso? Ngaba iimpawu zokuzixilonga ziyafumaneka?
• Zithini iindleko zokulondoloza? Ngaba izinto ezisetyenziswayo/izahlulo ezisecaleni (umzekelo, amaqweqwe eprobe) ziyafumaneka kwaye zonga imali?

17. Iindleko:

• Qwalasela iindleko zokuqala zokuthengwa kwempahla, iindleko zokulungisa (ukulinganisa, iindawo ezitshintshiweyo), kunye neendleko zizonke zobunini, ngelixa uhlangabezana nazo zonke iimfuno zokusebenza, ukhuseleko kunye nolawulo.

Isishwankathelo kunye neeNgcebiso

1.Chaza iiMfuno ngokucacileyo:Okokuqala, chaza ngokuchanekileyo imeko yesicelo sakho (yintoni ukulinganisa, phi, njani, iimfuno zokuchaneka, iimeko zokusingqongileyo, imimiselo yemarike ekujoliswe kuyo, njl.).
2.Beka phambili uKhuseleko kunye nokuThotyelwa: Ukuhambelana kwe-Biocompatibility, ukhuseleko lombane, kunye nesatifikethi sokulawula isixhobo sonyango yimigca ebomvu engenakuxoxisana.
3. Ukuchaneka kunye nokuthembeka yeyona nto ibalulekileyo:Qinisekisa ukuchaneka, ukuzinza, kunye nexesha lokuphendula phantsi koluhlu olujoliswe kuyo kunye neemeko zesicelo.
4.Qwalasela umjikelo opheleleyo woBomi:Vavanya ukusebenziseka, iindleko zokulondoloza (ingakumbi ukulinganisa), iimfuno zokubulala iintsholongwane/iintsholongwane, kunye nokuqina.
5.Khetha uMboneleli othembekileyo:Khetha ababoneleli abanamava aqinisekisiweyo kwicandelo lezonyango, igama elihle, kunye nokukwazi ukubonelela ngenkxaso ebanzi yobugcisa kunye namaxwebhu okuthotyelwa. Qonda iNkqubo yabo yoLawulo loMgangatho (umzekelo, isiqinisekiso se-ISO 13485).
6.Uvavanyo lwePrototype:Ukuqhuba uvavanyo olucokisekileyo kunye nokuqinisekiswa kwimeko yesicelo yangempela okanye iimeko ezifanisiweyo ngaphambi kokugqiba ukhetho.

Izicelo zonyango azishiyi ndawo yempazamo.Ukukhetha inzwa yobushushu kufuna ukulinganisa ngononophelo onke amanqaku aphambili ukuqinisekisa ukuba ikhuselekile, ichanekile, inokuthenjwa, kwaye iyathotyelwa, ngaloo ndlela inceda ngokwenyani uxilongo lwezonyango kunye nempilo yesigulana. Ukuba unemeko ethile yesicelo, ndinokubonelela ngeengcebiso ezijoliswe ngakumbi.