INALITHI YEPENINI YE-INSULIN CE ISO 510K IVUMISIWE
Izici Zomkhiqizo
| Ukusetshenziswa okuhlosiwe | Inaliti yepeni ye-insulin isetshenziselwa uketshezi lwe-insulin yangaphambi kwesifo sikashukelakugcwalisiweipeni le-insulin lomjovo we-insulin. |
| Isakhiwo kanye nokwakheka | Nisethi ye-edle, isivikeli senaliti ithiphu, isivikeli senaliti esisethiwe, iphepha elifakwe uphawu lwe-dialyzed |
| Indaba Eyinhloko | PE, PP, SUS304 Stainless Steel Cannula, Silicone Amafutha |
| Impilo yeshelufu | 5 iminyaka |
| Isitifiketi Nokuqinisekisa Ikhwalithi | Ihambisana ne-ISO11608-2 Ngokuthobelana ne-European Medical Device Directive 93/42/EEC(CE Class: Ila) Inqubo yokukhiqiza ihambisana ne-ISO 13485 kanye ne-ISO9001 Quality System. |
Amapharamitha womkhiqizo
| Usayizi Wenaliti | 29-33G |
| Ubude Benaliti | 4mm-12mm |
Isingeniso Somkhiqizo
Izinaliti zepeni le-insulin ye-KDL zenziwe ngezinto ezisezingeni eliphezulu kakhulu, okuhlanganisa ihabhu yenaliti, inaliti, ikepisi elincane lokuvikela, ikepisi elikhulu lokuvikela, nezinye izingxenye ezibalulekile.Njengoba yakhelwe ngokukhethekile ukusetshenziswa namapeni e-insulin agcwele uketshezi njengeNovo Pen, umkhiqizo wethu unikeza isisombululo esilula nesisebenzayo sokujova i-insulin.
Njengomkhiqizo wezinga lezokwelapha, sibeka phambili ukuphepha nempilo yamakhasimende ethu.Zonke izinto zokusetshenziswa, okuhlanganisa isivalo senjoloba, okokunamathelayo, nezinye izingxenye, kudlula izindinganiso eziqinile zezokwelapha ngaphambi kokuhlanganiswa.Izinaliti zethu ziphinde zenziwe inzalo ngenqubo ye-ETO (Ethylene Oxide) futhi ayinayo i-pyrogen.Lezi zinqubo ziqinisekisa ukuthi izinaliti azinazifo futhi zihlangabezana nezidingo zezokwelapha.
Izinaliti zethu zePeni le-insulin zihlezi phambili ekwakhiweni nasekusungulweni okusha ukuze kuqinisekiswe okuhlangenwe nakho okuphephile nokunethezekile.Amakepisi ethu amancane namakhulu avikelayo aqinisekisa ukuphepha okuphelele ngaphambi nangemuva kokusetshenziswa ukuze kuncishiswe ingozi yokulimala noma ukungcola.Inalithi yakhelwe ngokunembile imijovo engenabuhlungu enokujula nebanga eliphelele.Ihabhu yenaliti kulula ukulibamba futhi livumela inqubo yomjovo ezinzile.Lezi zici zenzelwe ukunikeza ukunethezeka okuphezulu ngesikhathi sokujova.
Ngezinaliti Zepeni le-insulin, ungakwazi ukwenza imijovo yakho ye-insulin kalula nangokuzethemba.Umkhiqizo wethu unikeza ukuthula kwengqondo ezigidini zabantu emhlabeni wonke abadinga imijovo ye-insulin.Ubuchwepheshe bethu obuthuthukisiwe kanye nokuqanjwa okusha kwezinto zokwakha kanye nokuklama kuqinisekisa ukuthi umkhiqizo awuhlanganisi nje kuphela kodwa udlule izindinganiso zemboni.
