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

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IINDABA

I-electrode yangaphakathi yeMedLinket yonyango lwemisipha yomgangatho we-pelvic ifumene isiqinisekiso sobhaliso lwe-FDA/CE/NMPA

YABELANA:

I-electrode yangaphakathi yonyango lwemisipha yomgangatho we-pelvic isetyenziswa ikakhulu kunye nokuvuselelwa kombane we-pelvic okanye i-EMG biofeedback host ukuhambisa isignali yokuvuselela umbane kunye nesignali ye-EMG yomgangatho we-pelvic.

I-electrode yangaphakathi yonyango lwemisipha ye-pelvic floor eyenziwe ngokuzimeleyo kwaye iyilwe yiMedLinket, eyaziwa ngokuba yi-pelvic floor rehabilitation probe kunye ne-incontinence probe, iqinisekiswe yi-China NMPA, i-US FDA 510 (k) kunye ne-EU CE, kwaye inokuthengiswa kwihlabathi liphela.

I-electrode yangaphakathi yeMedLinket yonyango lwemisipha yomgangatho we-pelvic ifumene isiqinisekiso sobhaliso lwe-FDA/CE/NMPA

Iprobe yokulungisa umgangatho we-pelvic kaMedLinket inokukhethwa ngokweenkcukacha ezahlukeneyo, kubandakanya i-electrode yamadoda kunye ne-electrode yabasetyhini. Inokukwazi ukuziqhelanisa nezixhobo ezahlukeneyo zokulungisa kwaye ikhethe ezinye iintlobo.Abavelisi bezixhobo zonyango beMedLinket abaneminyaka eli-17 ubudala banokwenza ngokwezifiso iprobe yokulungisa umgangatho we-pelvic ukuze ihambelane neemfuno zakho. Ukuba kuyimfuneko, ungaqhagamshelana nathi nangaliphi na ixesha~

iprobe yokungakwazi ukuzibamba


Ixesha lokuthumela: Septemba-27-2021

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.