Tunejejwe no kubamenyesha ko uburyo bushya bwo kugenzura umuvuduko wamaraso uri mu murongo w’ibicuruzwa bisanzwe bya Joytech byabonye neza FDA 510 (k) , bishyigikira ko biteguye isoko ry’ibikoresho by’ubuvuzi muri Amerika.
Iyemezwa ryemeza ko ibyo bikoresho byujuje ibisabwa n’amabwiriza y’Amerika mu bijyanye n’umutekano n’imikorere nkibikoresho by’ubuvuzi byo mu cyiciro cya II , kandi bihwanye cyane n’ibikoresho by’ibicuruzwa byemewe n'amategeko.
Ibishya Byakuweho Hejuru-Ukuboko Amaraso Yumuvuduko Ukurikirana
Moderi nshya yahanaguwe ni monitor yo hejuru yumuvuduko ukabije wamaraso yagenewe abakoresha muri rusange bakuze haba murugo ndetse no mubuvuzi.
Izi moderi ziri mubice bya Joytech Healthcare byashyizweho byerekana umuvuduko wamaraso ukurikirana ibicuruzwa , kandi bigashyiraho ibipimo bigezweho hamwe nubuhanga bwo gupima kugirango bunganire ubunararibonye bwabakoresha no gupima kwizerwa.
Bakoresha tekinoroji yo gupima umuvuduko wamaraso , ifasha gupima mugihe cuff inflation. Ibi bifasha kunoza imikorere yo gupima no gukoresha ihumure ryabakoresha , mugihe ukomeje gusoma neza kandi byizewe.
Imikorere ikurikirana yo murugo no gukoresha ivuriro
Ukurikije iboneza, ibikoresho birashobora gushiramo imirimo ikurikira:
Ikimenyetso cya Cuff Tightness Indicator , gishyigikira neza cuff progaramu mbere yo gupimwa
Ikimenyetso Cyimikorere Ikabije , ifasha kunoza ibipimo bihamye mugushakisha icyerekezo mugihe cyo gukoresha
AFIB (Atrial Fibrillation) imikorere yo gutahura , ishyigikira gusuzuma umutima udasanzwe mugihe cyo gupima
Imikorere ya MVM , itanga impuzandengo yikigereranyo cyinshi cyasomwe kugirango tunoze neza
Iyi mikorere yashizweho kugirango ishyigikire umuvuduko wamaraso wizewe haba mubuzima bwo murugo ndetse no gusuzuma ivuriro.
Ingano ya Cuff Ingano Iboneza
Ingano nini ya cuff iboneka irahari, harimo cm 22-36, cm 22-42, na cm 32-48 , zagenewe kwakira uruziga rutandukanye rwabantu bakuru kandi rukanapima neza neza mumatsinda atandukanye y'abakoresha.
Ibintu by'ingenzi byaranze ibicuruzwa
FDA 510 (k) yakuyeho moderi nshya mumurongo uriho ukurikirana umuvuduko wamaraso
Sisitemu yo kugenzura umuvuduko wamaraso
Ifaranga rishingiye ku gupima tekinoroji yo kunoza ihumure no gukora neza
Icyifuzo cya Cuff Tightness Indicator kugirango uhagarare neza
Icyifuzo Cyikirenga Cyimikorere Yerekana mugihe cyo gupima
Igikorwa cyo gutahura AFIB kubikorwa byo gutera umutima bidasanzwe
Imikorere ya MVM yo kunoza ibipimo bihoraho no gusubiramo
Ingano nyinshi ya cuff igereranya kubakuze
Birakwiye gukoreshwa murugo no gusuzuma ivuriro
Kubahiriza amabwiriza no kwitegura isoko
Icyemezo cya FDA 510 (k) cyerekana Joytech Healthcare yiyemeje kubahiriza amabwiriza n’ubuziranenge bw’ibicuruzwa ku masoko y’ubuzima ku isi, harimo na Amerika.
Imibare ijyanye na 510 (k) irahari kumugaragaro kandi irashobora kugenzurwa mububiko bwa FDA , byemeza gukorera mu mucyo no gukurikiranwa.
Amahirwe yo gufatanya kubakwirakwiza na OEM / ODM Abakiriya
Izi moderi zimaze gukosorwa ziraboneka kugirango zisuzumwe n’abakwirakwiza ibikoresho by’ubuvuzi, abatumiza mu mahanga, hamwe n’abafatanyabikorwa ba OEM / ODM bashaka ibisubizo bikurikirana byo kugenzura umuvuduko w’amaraso ku masoko yabo.
Twishimiye ubufatanye nabafatanyabikorwa bashishikajwe no gusuzuma ibicuruzwa, iterambere ryihariye ryigenga, hamwe ninkunga yo kohereza isoko mugukwirakwiza kwisi.
Ibyerekeye Ubuvuzi bwa Joytech
Ubuvuzi bwa Joytech ni uruganda rukora ubuvuzi bwurugo nibikoresho byogukurikirana ubuvuzi, kabuhariwe mugukurikirana umuvuduko wamaraso, therometero, pulse oximeter, nebulizers, pompe yamabere nibindi bicuruzwa byubuzima.
Dutanga OEM / ODM ibikoresho byubuvuzi ibisubizo ibirango byubuzima ku isi, abakwirakwiza, nabafatanyabikorwa, twibanda ku kubahiriza amabwiriza, kwizerwa ku bicuruzwa, n’ubufatanye burambye.
Twandikire
Kubisuzuma ryibicuruzwa, ibyangombwa bya tekiniki, cyangwa ubufatanye bijyanye natwe FDA 510 (k) yakuyeho moderi ikurikirana umuvuduko wamaraso , nyamuneka hamagara itsinda ryacu.
