NgoJuni 21, i-2017, i-China FDA ibhengeze i-14^thisaziso sezixhobo zonyango umgangatho kunye nomgangatho opapashiweyo wokulawula umgangatho kunye nemeko yokuhlola isampuli kwiindidi ezi-3 247 iiseti zeemveliso ezifana neetyhubhu zoqhoqhoqho ezilahlwayo, i-thermometer yonyango ye-elektroniki njl.

Iisampulu ezihlolwe ngokungacwangciswanga ezingahambelani nemigangatho yezixhobo zonyango ezibandakanya iindidi ezi-3 zeeseti zeemveliso eziveliswe ngabavelisi bezixhobo zonyango ezi-4; izinto ezihloliweyo ezinje ngokuchongwa kweelebhile, iincwadana njl.njl ezingahambelaniyo nemigangatho yodidi olu-1 lusete izixhobo zonyango eziveliswe ngabavelisi bezixhobo zonyango ezi-2; Iindidi ezi-3 ze-241 ziseta izixhobo zonyango eziveliswe ngabavelisi bezixhobo zonyango abangama-92 bahlangabezana nemigangatho efanelekileyo yazo zonke izinto ezihlolwe.

Okwangoku, uLawulo lweSizwe lokuTya neZiyobisi sele lucele amasebe olawulo lokutya neziyobisi kunye nolawulo lwasekhaya ukuba aphande kwaye ajongane namashishini afanelekileyo, kwaye acele amasebe afanelekileyo olongamelo lokutya neziyobisi kunye nolawulo lwephondo ukuba abhengeze ukuchithwa kwale meko eluntwini.

Ukuze komelezwe umgangatho wolawulo kunye nolawulo lwezixhobo zonyango kunye nokuqinisekisa ukusetyenziswa okukhuselekileyo nokusebenzayo kwezixhobo zonyango, i-FDA yethu yesizwe kutshanje yenza umgangatho wokubeka iliso kunye neesampuli ngokungqongqo ngokuhambelana nokuphindaphinda ukuya kumyinge wamaxesha ama-2 ngenyanga. Iquka ngokupheleleyo inkxalabo karhulumente ngezixhobo zonyango, kuyafuneka ukuba ume kuvavanyo lwemarike ukuba ufuna ukuya kule ndlela ikude.

I-Shenzhen Med-link Medical Electronics Co., Ltd. isoloko ifuna ukuba zonke iimveliso zihlangabezane nemigangatho yamva nje yesizwe neyehlabathi. Ekubeni yasekwa ngo-2004, emva kokucwangciswa konyaka-1, ibhetshi yokuqala ye-Med-link ye-ECG cable kunye neengcingo ezikhokelayo zadlula ukubhaliswa kwe-CFDA ngempumelelo, sisiqalo esihle kunye nobungqina obuhle bemigudu yethu.

Emva kweminyaka eyi-13 yophando olutsha kwinkalo yezixhobo zonyango ngo-2017, i-Med-link iphuhliswe ngokuzimeleyo iprobe yobushushu, inzwa ye-SpO₂ enokuphinda isetyenziswe, ipensile ye-ESU elahlayo, intambo yolwandiso lwe-pulse SpO₂, i-electrode yengqondo engasebenziyo, intambo ye-IBP njl.

Ngamava avavanyiweyo ixesha elide kwimarike yezixhobo zonyango, asiyi kuzibandakanya kwixesha elidlulileyo, kwaye asiyi kuvele sinyathele ngenyathelo. Ukuziqhelanisa nokutshintsha rhoqo imarike yezixhobo zonyango, ukuhlangabezana neemfuno zamva nje zamaqela ahlukeneyo, iMed-link Medical iya kuhlala isukela imigangatho ephezulu kunye nobuchwepheshe obuphezulu, kwaye ingqina amandla ethu ngomgangatho wemveliso.

Ukudibanisa ukhathalelo lobomi kunye nenkathalo, yenza abasebenzi bezonyango babe lula, abantu basempilweni!