I-insulin pen inaliti ye-CE I-510k yamkelwe
Iimpawu zeMveliso
Ukusetyenziswa kwenjongo | I-Insulin inaliti ye-Insulin ye-Insulin yeyokusetyenziswa ngolwesi-seswekile wangaphambiliifayilishweIpeni ye-insulin yenaliti ye-insulin. |
Ulwakhiwo kunye nokuqulunqwa | NI-Eeedi Set, inaliti ye-Inale, inaliti icwangcise umkhuseli, iphepha elitywiniweyo |
Inqaku eliphambili | I-PE, i-PP, uSUS304 i-cannula yentsimbi engenasilika, ioyile ye-silicone |
Beka ubomi kwishelufa | Iminyaka emi-5 |
Isiqinisekiso kunye nokuqinisekiswa komgangatho | Imbonakalo ye-ISO11608-2 Ngokuthotyelwa kwesikhokelo sesixhobo se-European 93/42 / i-EEC (CICE: ILA) Inkqubo yokwenziwa kukuhambelana ne-ISO 13485 kunye ne-ISO9001 yomgangatho. |
I-parameter yemveliso
Ubungakanani benaliti | 29-33g |
Ubude benaliti | I-4mm-12mm |
Intshayelelo Intshayelelo
Ipeni ye-KDL I-Insulin inaliti zenziwe kwezinto eziphezulu ezisemgangathweni, kubandakanya i-Inale Hub, inaliti, i-cap encinci yokukhusela, i-cap enkulu yokukhusela, kunye nezinye iindawo ezibalulekileyo. Yenzelwe ngokukodwa ukusetyenziswa kunye neepensile ezigcwalisa i-isulin ezifana nepeni yeNovo, imveliso yethu ibonelela ngesisombululo se-Insulin inaliti.
Imveliso yebanga lezonyango, sibeka phambili ukhuseleko kunye nempilo yabathengi bethu. Zonke izinto ezingafunekiyo, kubandakanya umphezulu werabha, ukubambelela, kunye namanye amalungu, ukuphumelela imigangatho yonyango engqongqo ngaphambi kwendibano. Iinaliti zethu zikwachithwa yinkqubo ye-ETO (ye-Ethylene oxide) kwaye yi-pyrogen-asimahla. Ezi nkqubo ziqinisekisa ukuba iinaliti zikhululekile kusulelo kwaye zifezekise iimfuno zonyango.
Iintsana zethu ze-insulin zihlala kwindawo yoyilo kunye nezinto ezintsha zokuqinisekisa ukuba amava akhuselekileyo nawo okhululekileyo. I-CAPS yethu encinci kunye nenkulu yokukhusela iqinisekisela ukhuseleko olupheleleyo ngaphambi nasemva kokusebenzisa ukunciphisa umngcipheko wokulimala okanye ungcoliseko. Inaliti ichanekile ngokwethu inaliti engenamasanda kunye nobunzulu bokufakela kunye nomgama. I-hub yenaliti ilula ukubamba kwaye ivumela inkqubo yenaliti. Ezi zinto zenzelwe ukubonelela ngenkuthazo enkulu ngexesha lenkqubo yenaliti.
Ngeentsana ze-Insulin inaliti, unokwenza inaliti yakho ye-insulin ngokuzithemba kunye nokuzithemba. Imveliso yethu ibonelela ngoxolo lwengqondo kwizigidi zabantu abasehlabathini lonke abafuna inaliti ye-Insulin. Itekhnoloji yethu yeTekhnoloji kunye nokuSebenza kweziBonelelo kwizixhobo kunye noyilo Qinisekisa ukuba imveliso ayihlangani kuphela kodwa idlula kwimigangatho yemveliso.