INLILI YEPEN YE-INSULIN CE ISO 510K IVUNYIWE
Iimpawu zeMveliso
| Ukusetyenziswa okucetywayo | Inaliti yosiba ye-insulin yeyokusetyenziswa kunye nolwelo lwe-insulin yesifo seswekileifayiliweipeni ye-insulin yokutofa i-insulin. |
| Isakhiwo kunye nokwakheka | Niseti yeedle, inaliti incam yomkhuseli, inaliti iseti umkhuseli, etywiniweyo dialyzed iphepha |
| Umxholo ophambili | I-PE, i-PP, i-SUS304 i-Cannula ye-Stainless Steel, i-Oli ye-Silicone |
| Beka ubomi kwishelufa | Iminyaka emi-5 |
| Izatifikethi kunye noQinisekiso loMgangatho | Ihambelana ne-ISO11608-2 Ngokuhambelana ne-European Medical Device Directive 93/42/EEC(CE Class: Ila) Inkqubo yokuvelisa ihambelana ne-ISO 13485 kunye ne-ISO9001 yeNkqubo yoBulunga. |
IiParameters zeMveliso
| Ubungakanani beNaliti | 29-33G |
| Ubude beNaliti | 4mm-12mm |
Intshayelelo yeMveliso
Iinaliti zeepeni ze-insulin ze-KDL zenziwe ngezona zinto ziphezulu, kubandakanywa ihabhu yenaliti, inaliti, ikepusi encinci yokukhusela, ikepusi enkulu yokukhusela, kunye nezinye iindawo ezibalulekileyo. Yenzelwe ngokukodwa ukuba isetyenziswe ngeepeni ze-insulin ezizaliswe lulwelo njengeNovo Pen, imveliso yethu ibonelela ngesisombululo esiluncedo nesisebenzayo sokutofwa kwe-insulin.
Njengemveliso yodidi lwezonyango, sibeka phambili ukhuseleko kunye nempilo yabathengi bethu. Zonke iimathiriyeli ekrwada, kubandakanywa isithinteli serabha, incamathelisa, kunye nezinye iindawo, zidlula imigangatho engqongqo yezonyango phambi kokuhlanganiswa. Iinaliti zethu zikwacocwa yi-ETO (Ethylene Oxide) inkqubo yokuvala inzala kwaye ayinayo ipyrogen. Ezi nkqubo ziqinisekisa ukuba iinaliti zikhululekile kusulelo kwaye zihlangabezana neemfuno zonyango.
Iinaliti zethu zePeni ye-Insulin zihlala phambili kuyilo kunye nokuveliswa kwezinto ezintsha zokuqinisekisa amava akhuselekileyo kwaye akhululekile. Izikhuselo zethu ezincinci nezinkulu ziqinisekisa ukhuseleko olupheleleyo ngaphambi nangemva kokusetyenziswa ukunciphisa umngcipheko wokulimala okanye ukungcoliseka. Inaliti yenzelwe ngokuchanekileyo iinaliti ezingenazintlungu ezinobunzulu bokufakwa kunye nomgama. Ihabhu yenaliti kulula ukubamba kwaye ivumela inkqubo isitofu ezinzile. Ezi mpawu zenzelwe ukubonelela ngentuthuzelo enkulu ngexesha lenkqubo yokutofa.
Ngeenaliti zePeni ye-insulin, unokwenza iinaliti zakho ze-insulin ngokulula nangokuzithemba. Imveliso yethu ibonelela ngoxolo lwengqondo kwizigidi zabantu kwihlabathi liphela abafuna inaliti ye-insulin. Itekhnoloji yethu ephezulu kunye nokuveliswa kwezinto ezintsha kunye noyilo luqinisekisa ukuba imveliso ayihlangani kuphela kodwa idlula imigangatho yoshishino.
