I-GlucoRX Vixxa3 Uhlelo Oluqhubekayo Lokuqapha I-Glucose
Ulwazi Olubalulekile
1.1 Izinkomba Zokusebenzisa
Inzwa ye-GlucoRx Vixxa™ 3 CGMS
iyidivayisi yesikhathi sangempela, eqhubekayo yokuqapha ushukela. Lapho uhlelo lusetshenziswa kanye nemishini ehambisanayo, luboniswa ekulawulweni kwesifo sikashukela kubantu abadala (abaneminyaka eyi-18 nangaphezulu). Iklanyelwe ukumiselela ukuhlolwa kwe-glucose ye-finger stick ukuze kuthathwe izinqumo zokwelashwa kwesifo sikashukela. Ukuhunyushwa kwemiphumela yesistimu kufanele kusekelwe kumathrendi e-glucose kanye nokufundwa okulandelanayo okuningana ngokuhamba kwesikhathi. Uhlelo luphinde luthole izitayela futhi lulandele amaphethini, futhi lusize ekutholeni iziqephu ze-hyperglycemia ne-hypoglycemia, kube lula ukulungisa kokubili ukwelashwa okubucayi nesikhathi eside.
1.1.1 Inhloso Ehlosiwe
Inzwa Yesistimu Yokuqapha I-Glucose Eqhubekayo: Uma Inzwa Yesistimu Yokuqapha I-Glucose Eqhubekayo isetshenziswa kanye nohlelo lokusebenza lwesofthiwe ehambisanayo, ihloselwe ukukala ngokuqhubekayo i-glucose oketshezini lwe-interstitial futhi iklanyelwe ukumiselela ukuhlolwa kwe-glucose yegazi (BG) yeminwe ukuze kuthathwe izinqumo zokwelashwa.
Uhlelo Lokusebenza Oluqhubekayo Lokuqapha I-Glucose (i-iOS/Android): Uma Uhlelo Lokusebenza Oluqhubekayo Lokuqapha I-Glucose lusetshenziswa kanye nezinzwa ezihambisanayo, luhloselwe ukukala ngokuqhubekayo i-glucose oketshezini lwe-interstitial futhi ludizayinelwe ukumiselela ukuhlolwa koshukela wegazi we-fingerstick (BG) ukuze kuthathwe izinqumo zokwelashwa.
1.1.2 Izinkomba
1) Thayipha 1 & 2 Diabetes Mellitus
2) Izinhlobo ezikhethekile zesifo sikashukela (ngaphandle kwe-monogenic diabetes syndromes, izifo ze-exocrine pancreas kanye nesifo sikashukela esibangelwa izidakamizwa noma ngamakhemikhali)
3) Izinga likashukela egazini elingavamile
4) Iziguli ezidinga ukulawulwa okuthuthukisiwe kwe-glycemic
5) Abantu abadinga ukuqapha njalo noma okuqhubekayo kweglucose yegazi.
1.2 Iziguli
Iziguli zabantu abadala ezinesifo sikashukela (iminyaka engu-2:18 ubudala).
1.3 Umsebenzisi Ohlosiwe
Abasebenzisi abaqondiwe balo mshini wezokwelapha ngabantu abaneminyaka engu-18 nangaphezulu, abanamakhono ayisisekelo okuqonda, ukufunda nokubhala kanye nokuzimela. Ihloselwe kokubili ochwepheshe bezokwelapha kanye nabantu abadala okungezona uchwepheshe okudingeka ngokuqhubekayo noma ngezikhathi ezithile baqaphe amazinga eglucose wabo noma abanye.
1.4 Ukungafani
I-Continuous Glucose Monitoring System kufanele isuswe ngaphambi kweMagnetic Resonance Imaging (MRI).
Ungayigqoki inzwa yakho ye-CGM ukuze uthole ukuskena kwe-computed tomography (CT) noma ukwelashwa kokushisa kagesi okuvama kakhulu (dia – thermy).
Ukuthatha okungaphezu komthamo omkhulu we-acetaminophen (isb> igremu elingu-1 njalo emahoreni ayi-6 kubantu abadala) kungase kuthinte ukufundwa kwe-CGM futhi kukwenze kubukeke kuphakeme kunalokho okuyikho ngempela.
Uhlelo lwe-CGM aluhlolwanga kubantu abalandelayo:
Uhlu Lomkhiqizo
Uhlu lomkhiqizo: Inzwa yesistimu yokuqapha ushukela eqhubekayo ihloselwe ukusetshenziswa kanye ne-CGM App njengohlelo. Uhlu lokuhambisana lumi kanje:
Imodeli ngayinye yenzwa ingasetshenziswa ngokuhambisana nanoma iyiphi imodeli yohlelo lokusebenza.
Izinhlelo zokusebenza neSoftware
3.1 Ukulanda Isofthiwe
Ungalanda i-Vixxa™ App ku-Apple App Store noma ku-Google Play. Sicela uhlole i-Operating System (OS) kudivayisi yakho yeselula ukuze uqiniseke ukuthi uthola inguqulo yohlelo lokusebenza efanele.
3.2 Izidingo Ezincane Ze
Ukufakwa kwesoftware ye-iOS
Inombolo Model: RC2111
Isistimu yokusebenza (OS): iOS 14 nangaphezulu
Imemori: 2GB RAM
Isitoreji: Ubuncane be-200 MB
Inethiwekhi: I-WLAN (Inethiwekhi Yendawo Engenantambo) noma i-cel-
inethiwekhi ye-lular, kanye nomsebenzi we-Bluetooth
Ukulungiswa Kwesikrini: 1334 * 750 pixels
Android
Inombolo Model: RC2112
Isistimu Esebenzayo (OS): I-Android 10.0 nangaphezulu.
Imemori: 8GB RAM
Isitoreji: Ubuncane be-200 MB
Inethiwekhi: I-WLAN (Inethiwekhi Yendawo Engenantambo) noma i-cel-
inethiwekhi ye-lular, kanye nomsebenzi we-Bluetooth
Ukulungiswa Kwesikrini: 1080 * 2400 pixels nangaphezulu
Qaphela
• Ukuze uthole izexwayiso, qiniseka ukuthi:
– Ukuvula umsebenzi we-Alert.
- Ukugcina umakhalekhukhwini wakho kanye nemishini ye-CGM ngaphakathi kwamamitha ama-2 (6,56ft) ubukhulu. Uma ufuna ukuthola izexwayiso kusukela kuhlelo lokusebenza, qiniseka ukuthi idivayisi yakho ixhunyiwe.
- Ungaphoqi ukuyeka i-Vixxa™ App okumele ngabe isebenza ngemuva ukuze uthole izexwayiso. Uma kungenjalo, izexwayiso azikwazi ukwamukelwa.
Uma izexwayiso zingatholakali, ukuqalisa kabusha uhlelo lokusebenza kungase kukusize.
- Hlola ukuze uqiniseke ukuthi unezilungiselelo ezifanele zefoni nezimvume ezivuliwe. Uma ifoni yakho ingalungiswanga kahle, angeke uze uthole izaziso.
• Uma ungasebenzisi ama-headphone noma izipikha, kufanele uzikhiphe ku-smartphone yakho, ngaphandle kwalokho, ungase ungasizwa isaziso. Uma usebenzisa ama-headphone, wabeke ezindlebeni zakho.
• Uma usebenzisa i-peripheral exhunywe ku-smartphone yakho, njengehedisethi engenawaya noma iwashi elihlakaniphile, ungase uthole izexwayiso kudivayisi eyodwa kuphela noma i-peripheral kunawo wonke amadivaysi.
• I-smartphone yakho kufanele ihlale ishajwa futhi ivuliwe.
• Vula uhlelo lokusebenza ngemva kokubuyekezwa kwesistimu yokusebenza.
3.3 Imvelo ye-IT
Ungasebenzisi Uhlelo Lokusebenza lapho umsebenzi we-Bluetooth uvaliwe, endaweni ye-Bluetooth eyinkimbinkimbi noma endaweni yokukhipha i-electrostatic ephezulu, ngaphandle kwalokho kuzobangela ukwehluleka kokufunda idatha kwesistimu eqhubekayo yokuthola ushukela. Ngoba i-Bluetooth izoba nezithiyo zokuxhumana ezindaweni eziyinkimbinkimbi ze-Bluetooth noma ezindaweni zokukhishwa kwe-electrostatic ephezulu. Abasebenzisi kudingeka baqinisekise ukuthi bahlala kude nezindawo ze-Bluetooth eziyinkimbinkimbi noma izindawo zokukhipha i-electrostatic ephezulu futhi baqinisekise ukuthi umsebenzi we-Bluetooth uvuliwe. Ayikho enye isofthiwe yangaphandle noma izinhlelo zokusebenza ezitholwe zidala ukukhubazeka okubucayi.
Ukusebenzisa endaweni enokuxhumana okubi kungase kubangele ukulahleka kwesignali, ukuphazamiseka kokuxhumeka, idatha engaphelele nezinye izinkinga.
I-Vixxa™ App Iphelileview
4.1 Impilo Yesevisi ye-CGM
Uhlelo lokusebenza luzoyeka ukunakekela eminyakeni emihlanu ngemva kokuba iqoqo lokugcina lamadivayisi e-CGM linqanyuliwe emakethe. Ngesikhathi sokulungiswa, kuyadingeka ukuqinisekisa ukusebenza okujwayelekile kwamaseva kanye nemisebenzi esebenzisanayo ehlobene namadivayisi e-CGM akumele ithinteke.
4.2 Ukusethwa kohlelo lokusebenza
4.2.1 Ukubhaliswa Kwesofthiwe
Uma ungenayo i-akhawunti, chofoza inkinobho ethi “Bhalisa” ukuze ufake isikrini sokubhalisa. Sicela ufake ikheli lakho le-imeyili kanye nephasiwedi. Funda Imibandela Yokusebenzisa kanye Nenqubomgomo Yemfihlo ngaphambi kokumaka ibhokisi. Ngokuqoka ibhokisi, uyavuma ukuthobela Imibandela Yokusebenzisa kanye Nenqubomgomo Yobumfihlo. Chofoza okuthi “Thumela ikhodi yokuqinisekisa ku-imeyili yami” ukuze uthole ikhodi enezinhlamvu eziyisithupha. Ngemva kokufaka ikhodi yokuqinisekisa, chofoza okuthi “Qhubeka” ukuze uqedele ukubhalisa kwakho. Imithetho yokusetha igama lomsebenzisi nephasiwedi yilena:
Igama lomsebenzisi:
Sebenzisa ikheli lakho le-imeyili njenge
igama lakho lomsebenzisi.
Iphasiwedi:
Iphasiwedi kumele iqukathe kokuthi
okungenani izinhlamvu eziyisi-8.
く
Iphasiwedi kumele ibe no-1
usonhlamvukazi, uhlamvu olu-1 oluncane
kanye nenombolo yenombolo engu-1.
4.2.2 Ukungena Kwesofthiwe
Sebenzisa ikheli le-imeyili le-akhawunti yakho ebhalisiwe kanye ne-Pass-
igama lokungena ku-App.
Qaphela
• Ungangena kuphela ku-akhawunti yakho kudivayisi eyodwa yeselula
ngesikhathi.
• Unomthwalo wemfanelo wokuvikela nokuphatha ngendlela efanele
ifoni yakho. Uma usola umcimbi ongemuhle we-cybersecurity
okuhlobene ne-Vixxa ™ App, xhumana ne-GlucoRx.
Qiniseka ukuthi ifoni yakho igcinwe endaweni ephephile, ngaphansi
ukulawula kwakho. Ungadaluli iphasiwedi yakho kwabanye. Lokhu
kubalulekile ukusiza ukuvimbela noma ubani ukuthi afinyelele noma a-tam-
ukuhamba neSistimu.
• Kunconywa ukusebenzisa uhlelo lokuvikela lwakho
umakhalekhukhwini, njengephasiwedi yokuvala isikrini, i-biometrics, ukuze
qinisa ukuvikelwa kwedatha ye-App.
Amadokhumenti / Izinsiza
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I-GlucoRX Vixxa3 Uhlelo Oluqhubekayo Lokuqapha I-Glucose [pdf] Incwadi Yeziqondiso IFU1034-PMTL-578.V01, 1034-PMTL-578.V01, Vixxa3 Continuous Glucose Monitoring System, Vixxa3, Continuous Glucose Monitoring System, Glucose Monitoring System, Monitoring System |