"Ngaphezulu kweminyaka engama-20 yoMvelisi weeCable zonyango zobungcali eTshayina"

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IINDABA

Isenzi se-EEG esingangenisi gazi seMedLinket siqinisekiswe yi-NMPA kangangeminyaka emininzi

YABELANA:

I-EEG sensor engasetyenziswayo elahlwayo, eyaziwa ngokuba yi-anesthesia deep EEG sensor. Yenziwe ikakhulu nge-electrode sheet, ucingo kunye nesixhumi. Isetyenziswa kunye nezixhobo zokubeka esweni i-EEG ukulinganisa imiqondiso ye-EEG yezigulane ngaphandle kokungenelela, ukujonga ixabiso lobunzulu be-anesthesia ngexesha langempela, ukubonisa ngokupheleleyo utshintsho lobunzulu be-anesthesia ngexesha lokusebenza, ukuqinisekisa iskimu sonyango lwe-anesthesia yeklinikhi, ukuthintela ukwenzeka kweengozi zonyango lwe-anesthesia, kunye nokubonelela ngesikhokelo esichanekileyo sokuvuka ngexesha lotyando.

I-sensor ye-EEG engangenisi gazi elahlwayo (2)

I-sensor ye-EEG engangenisi gazi elahlwayo eyenziwe ngokuzimeleyo kwaye iyilwe yi-MedLinket medical iphumelele ubhaliso kunye nesatifikethi se-China National Medical Products Administration (NMPA) ukusukela ngo-2014 kwaye iqatshelwe ukuba ihlaziywe kangangeminyaka emininzi. Ke ngoko, ikwathandwa ngamakhulu ezibhedlele ezaziwayo eTshayina. Izibhedlele ezininzi zikhethe ii-sensor ze-EEG ezingangenisi gazi ze-MedLinket kangangeminyaka emininzi ukuba zisetyenziswe kumagumbi otyando, kumasebe e-anesthesiology, kwi-ICU nakwamanye amasebe, oku kukwaqatshelwa kunye nokuthenjwa kwee-sensor ze-EEG ezingangenisi gazi ze-MedLinket.

I-sensor ye-EEG engangenisi gazi elahlwayo (1)

Emva kweminyaka yokuqinisekiswa kweklinikhi, iMedLinket iphuhlise ii-sensors ezahlukeneyo ze-EEG ezihambelana netekhnoloji yobunzulu be-anesthesia, kubandakanya ii-sensors ze-EEG ze-dual channel dual frequency index anesthesia depth EEG zabantu abadala nabantwana; i-Entropy index EEG sensor; i-EEG state index sensor; Kukho ii-sensors ezine ze-channel EEG dual frequency index; Kukwakho ne-sensor ye-EEG depth anesthesia depth EEG esandula ukuphuhliswa kunye nee-adapters ezahlukeneyo eziqhagamshelwe kwi-sensor ye-EEG. Okwangoku, iintlobo zee-sensors ze-MedLinket EEG ngokusisiseko zigubungela uninzi lwee-sensors ze-EEG ezifunekayo eklinikhi.

Ukongeza kwisicelo sayo sezonyango kwizibhedlele zasekhaya, iMedLinket ikwaphumelele isiqinisekiso se-CE kwaye yangena kwimarike ye-EU. Imarike yase-US ingeniswa ukuze ihlolwe. Kukholelwa ukuba kungekudala iza kuphumelela ubhaliso kunye nokuvunywa kwe-FDA yase-US kwaye ingene kwimarike yaseMelika ukunceda ukujonga ngokunzulu i-anesthesia kutyando lwezonyango ekhaya nakwamanye amazwe.

Ingxelo: Yonke into engentla ibonisa uphawu lwentengiso olubhalisiweyo, igama, imodeli, njl.njl., ubunini bomnini wokuqala okanye umenzi wokuqala, eli nqaku lisetyenziselwa ukubonisa kuphela ukuhambelana kweemveliso zase-United States, akukho okunye! Lonke ulwazi olungentla lubhekiselele kuphela, musa ukulusebenzisa njengeenkampani zonyango okanye iiyunithi ezinxulumeneyo, kungenjalo, lubangela naziphi na iziphumo kwaye inkampani ayinanto yakwenza.


Ixesha lokuthumela: Agasti-19-2021

PHAWULA:

1. Ezi mveliso aziveliswanga kwaye azigunyaziswanga ngumvelisi wezixhobo zokuqala. Ukuhambelana kusekelwe kwiinkcukacha zobugcisa ezifumaneka esidlangalaleni kwaye kunokwahluka ngokuxhomekeke kwimodeli yezixhobo kunye noqwalaselo. Abasebenzisi bayacetyiswa ukuba baqinisekise ukuhambelana ngokuzimeleyo. Ukuze ufumane uluhlu lwezixhobo ezihambelanayo, nceda unxibelelane neqela lethu lenkonzo yabathengi.
2. Iwebhusayithi ingabhekisa kwiinkampani zangaphandle kunye neempawu ezinganxulumananga nathi nangayiphi na indlela. Imifanekiso yemveliso yenzelwe iinjongo zokubonisa kuphela kwaye inokwahluka kwizinto zokwenyani (umz., umahluko kwimbonakalo okanye umbala wesixhumi). Kwimeko apho kukho nakuphi na ukungangqinelani, imveliso yokwenyani iya kuphumelela.