Ipeni le-INSULIN ANALIDI CE ISO 510K IVUMELWE
Izici Zomkhiqizo
| Ukusetshenziswa okuhlosiwe | Inaliti yepeni ye-insulin isetshenziswa noketshezi lwe-insulin olungaphambi kwesifo sikashukelakufakweipeni le-insulin lokujova i-insulin. |
| Isakhiwo kanye nokwakheka | Nisethi yama-eedle, isivikelo sesihloko senaliti, isivikelo sesethi yenaliti, iphepha elivaliwe eline-dialyse |
| Izinto Eziyinhloko | I-PE, i-PP, i-SUS304 I-Cannula Yensimbi Engagqwali, Uwoyela We-Silicone |
| Isikhathi sokuphelelwa yisikhathi | Iminyaka emi-5 |
| Isitifiketi kanye nokuqinisekiswa kwekhwalithi | Vumelana ne-ISO11608-2 Ngokuhambisana ne-European Medical Device Directive 93/42/EEC (Isigaba se-CE: Ila) Inqubo yokukhiqiza ihambisana ne-ISO 13485 kanye ne-ISO9001 Quality System. |
Amapharamitha Omkhiqizo
| Usayizi Wenaliti | 29-33G |
| Ubude Benaliti | 4mm-12mm |
Isingeniso Somkhiqizo
Izinaliti zepeni le-insulin ze-KDL zenziwe ngezinto ezisezingeni eliphezulu, kufaka phakathi ihabhu lenaliti, inaliti, isivalo esincane sokuvikela, isivalo esikhulu sokuvikela, nezinye izingxenye ezibalulekile. Yakhelwe ngqo ukusetshenziswa namapeni e-insulin agcwele uketshezi njengeNovo Pen, umkhiqizo wethu unikeza ikhambi elilula nelisebenzayo lokujova i-insulin.
Njengomkhiqizo osezingeni lezokwelapha, sibeka phambili ukuphepha nempilo yamakhasimende ethu. Zonke izinto zokusetshenziswa, okuhlanganisa nesivalo senjoloba, inhlaka, nezinye izingxenye, zidlula amazinga aqinile ezokwelapha ngaphambi kokuhlanganiswa. Izinaliti zethu nazo ziyahlanzwa ngenqubo yokuhlanza i-ETO (Ethylene Oxide) futhi azinazo i-pyrogen. Lezi zinqubo ziqinisekisa ukuthi izinaliti azinazo izifo futhi ziyahlangabezana nezidingo zezokwelapha.
Izinaliti zethu ze-Insulin Pen ziseqhulwini lokuklama kanye nokusungula izinto ezintsha ukuqinisekisa isipiliyoni esiphephile nesikhululekile. Izigqoko zethu zokuvikela ezincane nezinkulu ziqinisekisa ukuphepha okuphelele ngaphambi nangemva kokusetshenziswa ukuze kuncishiswe ingozi yokulimala noma ukungcola. Inaliti yenzelwe ngqo imijovo engenabuhlungu enobubanzi obuhle bokufakwa kanye nebanga. Ihabhu yenaliti kulula ukuyibamba futhi ivumela inqubo yokujova ezinzile. Lezi zici zenzelwe ukunikeza induduzo ephezulu ngesikhathi senqubo yokujova.
Ngezinaliti ze-Insulin Pen, ungenza imijovo yakho ye-insulin kalula nangokuzethemba. Umkhiqizo wethu unikeza ukuthula kwengqondo ezigidini zabantu emhlabeni wonke abadinga imijovo ye-insulin. Ubuchwepheshe bethu obuthuthukisiwe kanye nokusungula izinto ezintsha kanye nokuklama kuqinisekisa ukuthi umkhiqizo awugcini nje ngokuhlangabezana nezindinganiso zomkhakha kodwa futhi udlula amazinga.
