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

English

Umfanekiso oPhambili we-MedLinket Maibang Compatible Holter ECG

I-MedLinket Maibang Ihambelana neHolter ECG

Ikhowudi yeodolo:HC024-7A

*Ukuze ufumane iinkcukacha ezithe vetshe ngemveliso, jonga ulwazi olungezantsi okanye unxibelelane nathi ngqo

ULWAZI LWE-ODOLA

QHAGAMSHELANA NGOKU

Uphawu lweMveliso

1. Yahlulwe yaba: iingcingo zentambo kunye neentambo zentsimbi, iingcingo zentsimbi ezimgca omnye kunye neengcingo zentsimbi ezinxalenye enye.
Iintambo ze-ECG ze-holter ze-Med-link zinekhaka eliphindwe kabini ukunciphisa ukuphazamiseka okungashukumiyo.
3. Yandisa ukuguquguquka kuzo zombini iziphelo zezihlanganisi ukutsalwa koxinzelelo lwentambo ye-ECG ukuze kuthintelwe ukonakala okuqhubekayo kwiintambo kunye nezihlanganisi.
4. I-splitter inekhowudi ecacileyo yombala weempawu zaseYurophu (IEC) kunye nezaseMelika (AAMI), evumela uqhagamshelo olukhawulezayo nolulula kwiintambo ze-lead.
5. Izihlanganisi ezahlukeneyo zentambo ye-lead zinokuhambelana nezixhobo ezahlukeneyo zokujonga.
6. I-Med-link inikezela ngee-Din 3 Leads, ii-5 leads, ii-7 leads, ii-10 leads ze-ECG leads, ukuhlangabezana neemfuno ezingakumbi zemonitha.
7. Uyilo olulula nolungenasithintelo lwentambo yentsimbi kunye noyilo olufana nolwe-drop luthintela ukudideka kwezihlanganisi zesiphelo sesigulana.
8. Isiqinisekiso semveliso esipheleleyo, i-CFDA, i-CE, ivunyiwe yi-FDA.

Umsebenzi weMveliso

Ngokusebenzisa iintambo ze-holter lead, qhagamshela ne-Holter ECG monitor, ujonge rhoqo i-ECG kwizigulane. Njengomvelisi ochwephesha weendibano ezahlukeneyo zekhebula zonyango ezisemgangathweni, i-Med-link ikwangomnye wababoneleli abaphambili beentambo ze-holter eTshayina. Umzi-mveliso wethu uxhotyiswe ngezixhobo eziphambili kunye neengcali ezininzi. Ngesiqinisekiso se-FDA kunye ne-CE, ungaqiniseka ukuba uza kuthenga iimveliso zethu ezenziwe eTshayina ngexabiso elifanelekileyo. Kwakhona, inkonzo eyenzelwe wena iyafumaneka.

Ipharamitha yeMveliso

Imifanekiso yeMveliso	I-MED-LINK REF NO.	Ibhrendi kunye neModeli ehambelanayo	Inkcazo (Igama, Ubude, Iplagi, Iyahambelana)
	HC024-7A	Izixhobo zeBiomedical (BI): BI 9000 IBrentwood: BH-3000	Iingcingo ze-lead ze-5-Ld
iinkcukacha zokupakisha		24 / iibhokisi

Qhagamshelana Nathi Namhlanje

Njengomvelisi ochwephesha weenzwa zonyango ezahlukeneyo ezisemgangathweni kunye neendibano zekhebula, iMedLinket ikwangomnye wababoneleli abaphambili beSpO₂, ubushushu, i-EEG, i-ECG, uxinzelelo lwegazi, i-EtCO₂, iimveliso ze-electrosurgical ezisebenza rhoqo, njl. Ifektri yethu ixhotyiswe ngezixhobo eziphambili kunye neengcali ezininzi. Ngesatifikethi se-FDA kunye ne-CE, ungaqiniseka ukuba uza kuthenga iimveliso zethu ezenziwe eTshayina ngexabiso elifanelekileyo. Kwakhona, iinkonzo ezenzelwe wena ze-OEM / ODM ziyafumaneka.

Iithegi ezishushu:

Ngaphambili: Iintambo ze-ECG zeHolter Recorder ezineentambo zeLeadwires

Okulandelayo: Iintambo ze-ECG Telemetry

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.