NMPA ta ba da izinin ƙirƙira ga tsarin kewayawa na Injin tiyata na Intuitive kuma ta fitar da rahoton bita.

Waɗannan rahotannin bita da aka buga sun zama mahimman nassoshi don ku fahimci abin da hukumomi ke tunani da kimantawa yayin aikin bitar su. Mun kasance muna bin lissafin shekaru da yawa da suka gabata muna yin nazarin abubuwan da suka dace don takamaiman samfuran abokan cinikinmu don samun ƙarin haske kuma mu kasance masu inganci a cikin ƙaddamarwa da tsarin amincewa. Kamar yadda NMPA ke daidaitawa da daidaita tsarin bita don amincewa da sauri, manyan 'yan wasa a cikin sararin samaniya kamar Medtronic, J & J, Jiki Vision Medical, Veran Medical da Nuhu Medical na iya amfana daga gwaninta da kwarewa.

Siffar samfurin

• Tsarin samfur da abun da ke ciki
• Amfanin da ake nufi

Wannan samfurin ya ƙunshi sassa huɗu: tsarin sarrafa kewayawa, sanya catheter, bincike na gani da jagorar catheter.

Ana amfani da sassan guda huɗu tare don samar da nau'ikan sake gina huhu mai girma uku da kuma jagorar hanyoyi dangane da hotunan CT na haƙuri, yin nunin hoto na bishiyar mashaya mai girma, da kuma taimaka wa likitoci wajen kewayawa da matsayi a cikin nama na huhu.

Bronchoscope kewayawa na gani fiber sakawa catheter, sarrafawa da wani inji hannu, ana shiryar da nisa zuwa yankin da ake nufi da bronchus don samar da matsayi na bayanai da kuma zama a matsayin kayan aiki tashar don dacewa kayan aiki kamar bronchoscope kewayawa hangen nesa bincike da biopsy allura.

Ana amfani da binciken gani na gani na bronchoscope don kallon hoto da kuma samar da hasken ƙwayar cuta.

Ana amfani da jagorar kewayawa na gani na fiber na gani na filayen catheter don tallafawa bronchoscope kewayawa na gani fiber sakawa catheter don hana lankwasawa da nakasar axis catheter.

• Model / Musammantawa
• Tsarin aiki

Pre-asibiti

• Ƙimar Ayyukan Samfur

An ba da bincike da tattara kayan aikin bincike na kayan aikin samfur da buƙatun fasaha, waɗanda suka haɗa da ƙayyadaddun ƙayyadaddun tsarin aiki (kewayon motsi, daidaiton sarrafawa, daidaiton matsayi, aikin tsarin, aikin software, tsaro na cibiyar sadarwa), sanya aikin catheter (aikin aiki, injiniyoyi). aiki, aikin taro, aikin sinadarai), aikin bincike na gani (ingancin hoto, aikin haskakawa, aikin rufewa, aikin haɗin gwiwa, aikin sinadarai), aikin jagorar catheter (aikin aiki, ƙarfin haɗin gwiwa, aikin sinadarai), kazalika da ƙayyadaddun tushen don alamomin aiki da aminci kamar amincin lantarki da daidaitawar lantarki.

• Halittu

Mai nema ya kimanta daidaituwar yanayin catheter na sakawa, bincike na gani kai tsaye cikin hulɗa da marasa lafiya, da jagorar catheter a kaikaice cikin hulɗa da marasa lafiya bisa ga GB/T 16886.1-2011. Abubuwan da aka kimanta sun kasance a cikin ɗan gajeren lokaci tare da ƙwayar mucosal na mutum, kuma an gudanar da gwaje-gwajen nazarin halittu (cytotoxicity, intradermal reaction, sensitization). An gabatar da rahoton gwajin halittu da cibiyoyin gwaji na ketare suka bayar.

• sterilization

Abubuwan da aka gyara kamar hannun injina da na'ura wasan bidiyo na sarrafawa kawai suna buƙatar tsaftacewa da ƙazantawa. Mai nema ya ba da ingantattun bayanai don rigakafin matakin matsakaici.

Matsakaicin catheter da bincike na gani don dalilai ne da za a sake amfani da su, kuma masu amfani suna da alhakin tsaftacewa da babban matakin lalata, yawanci ta hanyar nutsar da sinadarai. Mai nema ya ƙaddamar da bayanan bincike game da ingancin tsaftacewa, ingancin ƙwayar cuta, da kuma dacewa, tare da ingantattun bayanai don tasirin hana ruwa na murfin rufewa da aka yi amfani da shi yayin aikin lalata.

Hakanan ana iya sake amfani da jagorar catheter kuma ana yin tsaftacewa da haifuwa. Hanyar haifuwa ta ƙunshi babban zafin jiki da tururi mai ƙarfi. Mai nema ya ƙaddamar da bayanan bincike kan ingancin tsaftacewa, ingancin haifuwa, da dacewa.

• Rayuwar Shelf samfurin da Marufi
• software
• Amintaccen na'urar aiki
• Daidaiton Nazarin

Mai nema ya ba da bayanan ingantattun bayanai akan daidaiton rajistar fusion na gabaɗayan tsarin dangane da samfuran alade masu rai. An gudanar da wannan tabbatarwa ta hanyar amfani da maƙasudin ƙima don sakawa da yin alama, yin kwatankwacin ainihin ayyukan asibiti don tabbatar da tsarin. A lokacin wannan tsari, an yi wa dabbobin gwaje-gwaje na rediyo don tabbatar da rashin lafiyar al'amuran kamar zubar jini ko rauni. An samar da bayanai kan daidaiton magudi, ta yin amfani da na'urar binciken gani na infrared na ɓangare na uku (NDI) don dubawa. Gwaji dangane da daidaiton saka fiber na gani ya nuna sakamako ya cika buƙatun asibiti.

Bugu da ƙari, an ba da bayanan tabbatarwa kan daidaiton tsarawa. Wannan ya haɗa da kwatanta aikin tsarin da na balagagge kuma sanannen software riga a kasuwa. An dauki daidaito tsakanin su biyun an yarda.

Clinical

Mai nema ya gudanar da kimantawa na asibiti tare da kwatancen predicate. Ya zaɓi na'urar tsinkaya, Platform na Masarautar Kiwon Lafiya ta Auris, wanda ya riga ya kasance a kasuwar China. Mai nema yana kwatanta samfurin da aka ayyana tare da irin wannan samfurin dangane da ƙa'idodi na asali, tsarin tsari, da iyakokin aikace-aikace. Akwai bambance-bambance a cikin sigogin aiki da kayan masana'anta. Don magance waɗannan bambance-bambance, an gudanar da cikakkun gwaje-gwaje don tantance tsarin kewayawa, matsayi, da daidaiton tsarin. Waɗannan gwaje-gwajen sun haɗa da gwajin benci, gwaje-gwajen dabbobi, da gwaje-gwajen cadaver.

Gwaje-gwajen benci sun haɗa da madaidaicin gwajin bisa tsarin ɗan adam, kimanta daidaiton huda da aikin tsara aikin tiyata. Sun tabbatar da daidaiton tsara software a cikin karantawa, aunawa, da nuna bayanan CT. Gwajin aikin rajista ya nuna ikon samfurin don kammala duk matakan rajista, yayin da aikin kewayawa yana gwada ingantattun ayyukan software, samun damar catheter, da daidaiton matsayi.

Gwaje-gwaje na dabba, wanda aka gudanar akan aladu masu rai, sun ƙunshi nazarin hudu. Na farko yana da nufin tabbatar da aminci da amfani, yin kwaikwayon shirye-shiryen kafin fara aiki, rajista, ayyukan huda biopsy, da kula da gaggawa. An ƙididdige ƙimar nasarar isa ga wurare daban-daban na jiki, ba tare da wani mummunan tashin hankali ba da ƙimar pneumothorax a cikin iyakokin da aka yarda.

Nazarin na biyu, kuma akan samfuran alade masu lafiya, ya mai da hankali kan tabbatar da daidaiton huda. An yi amfani da dasa samfuran ƙari (diamita 10-20mm) a cikin hanyoyin iska na dabba don tabbatar da ƙimar nasarar huda, wuce ƙa'idodin yarda da aka saita.

Nazarin na uku, har yanzu akan samfuran alade masu lafiya, da nufin tabbatar da samun dama da daidaito a cikin alamar nodules a cikin hanyoyin iska. An sami nasarar yin alama ta samfuran ƙari ta amfani da alamar alamar.

Nazarin na huɗu, kuma akan samfuran alade masu lafiya, da nufin tabbatar da samun dama ga nodules a cikin hanyoyin iska da kuma tabbatar da buƙatun samfur. An nuna nasarar kawar da girma mai girma a cikin hanyoyin iska.

Gwaje-gwajen Cadaver sun yi niyya don tabbatar da daidaiton kewayawa, huda madaidaicin, da samun damar zuwa wuraren yanar gizo masu ƙalubale. An dasa raunuka masu yawa a cikin huhu na cadavers, kuma ƙimar huda nasara ta wuce matsayin da ake tsammani.

Bugu da ƙari, binciken asibiti da aka gudanar a Ostiraliya tare da batutuwa 30 da ke da nufin tallafawa amfanin samfur. Binciken ya nuna ƙimar nasarar kewayawa 100% da ƙimar nasarar biopsy 96.7%, ba tare da abubuwan da suka shafi na'urar ba.

Baya ga waɗannan gwaje-gwaje, mai nema ya ba da bayanan aikace-aikacen asibiti bayan amincewa daga ƙasashen waje.

Da fatan za a yi mana imel a info@ChinaMedDevice.com don ganin idan NMPA ta fitar da rahotannin bita na na'urar ku. Za mu iya fassara muku tare da kuɗaɗen ƙima.

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• Source: https://chinameddevice.com/navigational-bronchoscopy-system/