I-eversense Isistimu Yokuqapha I-Glucose Eqhubekayo

Ulwazi Lomkhiqizo

I-Eversense CGM System iwuhlelo oluqhubekayo lokuqapha ushukela olwenzelwe abantu abadala (abaneminyaka eyi-18 nangaphezulu) abanesifo sikashukela. Kuhloswe ukukala amazinga eglucose e-interstitial kuze kufike ezinsukwini ezingama-90. Uhlelo luthatha indawo yesidingo sokukala ushukela wegazi ngomunwe futhi lunikeze izibikezelo ze-glucose ephansi yegazi (hypoglycemia) neziqephu ze-glucose ephezulu (hyperglycemia). Iphinde inikeze ukutolika kwedatha yomlando ukusiza ekulungiseni ukwelashwa okusekelwe emaphethini namathrendi abonwe ngokuhamba kwesikhathi.

Uhlelo luqukethe inzwa, i-smart transmitter, nohlelo lokusebenza lweselula. Inzwa iyi-MR Conditional futhi kufanele isuswe ngaphambi kokwenza izinqubo ze-magnetic resonance imaging (MRI). I-smart transmitter inika amandla inzwa, ibala ukufundwa kwe-glucose, igcine futhi ithumele idatha kuhlelo lokusebenza, futhi inikeza izexwayiso ze-vibe esemzimbeni. Ivikelwe esikhumbeni nge-adhesive patch elahlayo edinga ukushintshwa nsuku zonke.

I-Eversense CGM System ayinconywa kubantu abavinjelwa ukusetshenziswa kwe-dexamethasone noma i-dexamethasone acetate, noma kulabo abenza izinqubo ze-MRI. Ukwengeza, isistimu ingase inikeze imiphumela yenzwa ye-glucose ephakeme ngokungekho emthethweni uma isetshenziswa ihlanganiswe nezinto ezinegazi le-mannitol noma i-sorbitol.

Imiyalo yokusetshenziswa komkhiqizo

1. Ukugqoka i-Smart Transmitter:
   • Faka isiqephu sokunamathisela esilahlwayo ukuze uvikele isidlulisi esihlakaniphile esikhumbeni sakho.
   • I-smart transmitter ingagqokwa nsuku zonke futhi ingasuswa futhi ifakwe kabusha nganoma yisiphi isikhathi.
   • Qaphela: Isidluliseli esihlakaniphile asikwazi ukumelana namanzi (IP67) kufika ekujuleni kwemitha elingu-1 (amafidi angu-3.2) kufika kumaminithi angu-30.
2. UKUVULA NOKUVALA I-Smart Transmitter:
   • UKUVULA i-smart transmitter, cindezela bese ubamba inkinobho yamandla cishe imizuzwana emihlanu.
   • UKUVALA i-smart transmitter, cindezela bese ubamba inkinobho yamandla cishe imizuzwana emihlanu.
   • Ukuhlola ukuthi i-smart transmitter IVULIWE yini, cindezela inkinobho yamandla kanye. Uma isibonisi se-LED sikhanyisa ngokuluhlaza noma okuwolintshi, kusho ukuthi isidluliseli esihlakaniphile IVULIWE. Uma ingekho i-LED evelayo, kusho ukuthi i-smart transmitter IVALIWE.
3. Izinyathelo Zokuqalisa:
   • Qiniseka ukuthi i-smart transmitter ishajwe ngokugcwele ngaphambi kokuyimatanisa nohlelo lokusebenza lweselula.

Bheka ku-Eversense CGM User Guide ukuze uthole ulwazi oluningiliziwe.

Ukuze uthole inguqulo yeSpanishi yoMhlahlandlela Womsebenzisi kanye ne-Quick Reference Guide, sicela uvakashele www.eversensediabetes.com.

Izinkomba Zokusetshenziswa

I-Eversense CGM System ihloselwe ukukala ngokuqhubekayo amazinga eglucose e-interstitial kubantu abadala (abaneminyaka eyi-18 nangaphezulu) abanesifo sikashukela kuze kufike ezinsukwini ezingama-90. Uhlelo lukhonjiswe ukuthi lusetshenziselwe ukufaka esikhundleni sokukala ushukela wegazi weminwe ezinqumweni zokwelashwa kwesifo sikashukela.

Uhlelo luhloselwe:

• Nikeza i-glucose yesikhathi sangempela
• Nikeza umkhuba we-glucose
• Nikeza izexwayiso zokutholwa nokuqagela iziqephu ze-glucose ephansi (hypoglycemia) kanye noshukela wegazi ophakeme (hyperglycemia).
• Uhlelo luyidivayisi kadokotela. Idatha yomlando evela ohlelweni ingahunyushwa ukuze isize ekunikezeni ukwelashwa Lokhu kulungiswa kufanele kusekelwe emaphethini kanye nezitayela ezibonwa ngokuhamba kwesikhathi.
• Uhlelo luhloselwe isiguli esisodwa

Contraindications

• Uhlelo aluvunyelwe kubantu okungenzeka ukuthi i-dexamethasone noma i-dexamethasone acetate
• I-smart transmitter ayihambisani ne-magnetic resonance imaging (MRI) Isidluliseli esihlakaniphile singu-MR Akaphephile futhi KUMELE SIKUSWE ngaphambi kokwenza inqubo ye-MRI (magnetic resonance imaging). Inzwa ingu-MR Conditional. Ukuze uthole ukwaziswa okwengeziwe ngenzwa, bheka Ulwazi Lokuphepha lwe-MRI kwe I-Eversense CGM System User Guide.
• I-Mannitol noma i-sorbitol, lapho ifakwa emthanjeni, noma njengengxenye yesisombululo sokunisela noma isixazululo se-peritoneal dialysis, ingakhuphula ukugxila kwe-mannitol noma i-sorbitol futhi ibangele ukufundwa okungalungile kwenzwa yakho ye-glucose I-Sorbitol isetshenziswa kwezinye izishukela zokwenziwa, kanye namazinga okugxilisa ingqondo kusuka kokujwayelekile. Ukudla akuthinti imiphumela ye-glucose yezinzwa.

Ukwenza Izinqumo Zokwelashwa nge-Eversense              

Ukuze wenze isinqumo sokwelashwa, kufanele ucabangele:

• Ulwazi lwebha yesimo
• Inani le-glucose yenzwa yamanje - inani le-glucose yamanje kufanele liboniswe ngokumnyama
• Umcibisholo wethrendi - umcibisholo wethrendi kufanele uboniswe
• Ulwazi lwethrendi yakamuva nezexwayiso

Kunini lapho ONGINGASENZI khona isinqumo sokwelashwa:

• Alikho inani le-glucose eliboniswayo
• Awukho umcibisholo wethrendi oboniswayo
• Izimpawu zakho azifani nolwazi lwe-glucose olubonisiwe
• Inani le-glucose yenzwa yamanje liboniswa ngokumpunga
• Ibha yesimo ikhonjiswa ngowolintshi
• Uthatha imithi yekilasi le-tetracycline

Qaphela: Njalo bheka ulwazi lweglucose ku-Eversense CGM App yakho ku-smartphone yakho ukuze wenze izinqumo zokwelashwa. Ungasebenzisi isibonisi sesibili njenge-Apple Watch noma i-Eversense MANJE.

I-Eversense Smart Transmitter

I-smart transmitter yakho eshajwa kabusha inika amandla inzwa, ibala ukufundwa kweglucose, futhi igcine futhi ithumele idatha kuhlelo lokusebenza. Iphinde inikeze izexwayiso ze-vibe emzimbeni. I-smart transmitter ivikelwe esikhunjeni sakho nge-adhesive patch eshintshwa nsuku zonke

Ukugqoka i-smart transmitter

• Faka esikhundleni se-adhesive patch ku-smart transmitter yakho
• I-smart transmitter ingasuswa futhi ifakwe esikhumbeni nganoma yisiphi isikhathi

Qaphela: I-smart transmitter yakho ayizwani namanzi (IP67) ukuya ekujuleni kwemitha elingu-1 (3.2 amafidi) kuze kube yimizuzu engama-30

VULA futhi UVALE I-Smart Transmitter

• UKUVULA isidlulisi esihlakaniphile, cindezela bese ubamba inkinobho yamandla cishe imizuzwana emihlanu.
• Ukuze uvale i-smart transmitter, cindezela bese ubamba inkinobho yamandla cishe imizuzwana emihlanu.

Ukuze ubone ukuthi i-smart transmitter yakho IVULIWE, cindezela inkinobho yamandla kanye. Uma kuvela i-LED, i-smart transmitter IYAVULIWE. Uma ingekho i-LED evelayo, i-smart transmitter IYAVALWA.

Izinyathelo Zokuqalisa  

Ukushaja i-Smart Transmitter

I-smart transmitter yakho kufanele ishajwe ngokugcwele ngaphambi kokumataniswa nohlelo lokusebenza.

• Xhuma isiphetho esijwayelekile sekhebula le-USB ku-adaptha ku-USB
• Xhuma isiphetho esincane sekhebula le-USB embotsheni ye-USB yembeleko yokushaja
• Layisha izikhonkwane ezine zegolide ngaphansi kwesidluliseli esihlakaniphile nezikhonkwane ezine zegolide ekushajeni Uma sezishajwe ngokuphelele (cishe imizuzu eyi-15), ukukhanya okuncane okuluhlaza kuvela ohlangothini olungaphezulu lwesidluliseli esihlakaniphile. Khipha ikhebula le-USB kumbeleko wokushaja ngemva kokuba selishajwe ngokugcwele ngokudonsela emuva kuthebhu esembelekweni, futhi uphakamisele ngaphandle isidluliseli esihlakaniphile.

KUBALULEKILE:
Sebenzisa kuphela i-adaptha yamandla e-AC kanye nekhebula le-USB elinikezwe isidluliseli esihlakaniphile lapho ushaja ibhethri lesidlulisi esihlakaniphile, futhi ungalokothi unamathisele enye into ngaphandle kwekhebula lokushaja embobeni ye-USB yesithumeli. Ukusebenzisa omunye ugesi kungalimaza isidluliseli esihlakaniphile, kungavumeli ukufundwa kweglucose ukuthi kwamukelwe ngendlela efanele, kudaleke ingozi yomlilo, futhi kungaholela ekuvaleni iwaranti yakho. Uma i-adaptha yakho yamandla ye-Eversense noma ikhebula le-USB lilimele noma ilahleka, xhumana Nokwesekwa Kwamakhasimende ukuze uthole okushintshile ukuze uqinisekise ukusebenza okuphephile kocingo.

Yethula uhlelo lokusebenza ngokuthepha isithonjana se-Eversense

1. Dala i-akhawunti nge-imeyili futhi
2. Faka imininingwane ye-akhawunti yakho bese uthinta Thumela.
3. Khombisa ukuthi une-smart transmitter yakho ngokuthepha leyo nketho.
   Ukuze uqedele ukubhalisa hlola ikheli le-imeyili olinikezile bese uchofoza isixhumanisi esiku-imeyili.
   Qaphela: Kuzinhlelo zokusebenza ze-Android uzoyalwa ukuthi wazise futhi unike amandla izinsiza zendawo noma ze-Bluetooth ukuze ubhanqe isidlulisi sakho esihlakaniphile nedivayisi yakho yeselula futhi uthole izexwayiso ohlelweni lwe-Eversense CGM.
4. Vula i-smart transmitter bese usetha ku-“Discoverable Mode” ngokucindezela inkinobho yamandla kathathu. Isibani se-LED sizocwayiza ngokuluhlaza nokuwolintshi.
5. Thepha Akuxhunyiwe ukuze uqale inqubo yokumatanisa. Qaphela: Uma ungaboni i-smart transmitter yakho njengenketho bona Umhlahlandlela Womsebenzisi ukuze uthole ulwazi olwengeziwe.
6. Thinta Bhangqa bese uthinta Okulandelayo ukuze uqhubeke lapho kuvela okuthi “Kuxhunyiwe”.
7. Iyunithi yokulinganisa isetshenziselwa ukubala nokubonisa ukufundwa kweglucose yakho. UNGALIshintshi iyunithi yokulinganisa uze uthintane nomhlinzeki wakho wokunakekelwa kwezempilo. Thepha okuthi Qeda ukuze uqhubeke
8. Thepha ngezikrini zesingeniso ezihlinzeka ngolwazi mayelana nokuthi uzenza nini izinqumo zokwelashwa nge-Eversense CGM System.
9. Thepha isithonjana se-MAIN MENU ukuze uthole ukufinyelela kuyo yonke imisebenzi yohlelo lokusebenza kusuka kumenyu yokudonsela phansi.
   Qaphela: Lesi sikrini ngeke sibe nedatha ye-glucose ezoboniswa kuze kube yilapho inzwa yakho isifakiwe futhi usuqalile ukulinganisa isistimu.

I-Eversense App

Isikrini se-MY GLUCOSE sizobonisa idatha yakho ye-glucose uma inzwa yakho isifakiwe futhi usuqalile ukulinganisa uhlelo.

• Isithonjana semenyu (bona ikhasi elilandelayo)
• I-Temp Profile isithonjana
• Isithonjana sokungaphazamisi
• Ukufundwa kweglucose yamanje
• Uxhumano lwe-Transmitter kunzwa
• Amandla ebhethri e-Transmitter
• Umcibisholo othrendayo
• Izinga eliphezulu lokuqwashisa nge-glucose
• Izinga eliphezulu le-glucose target
• Izinga le-glucose target eliphansi
• Izinga lesexwayiso se-glucose ephansi
• Isithonjana serekhodi lomcimbi

1. Ukuzivocavoca
2. Imicimbi eminingi
3. Isexwayiso Esibikezelwe NgeGlucose Ephezulu
4. I-insulin
5. Ukulinganisa

Isithonjana Semenyu

Thepha isithonjana se-MENU ( ) phezulu kwesokunxele sanoma yisiphi isikrini ukuze uzulazule uye kunoma yiziphi izinketho zemenyu ezitholakalayo:

• IGlucose Yami
• Linganisa
• Umlando Wokwazisa
• Irekhodi Lomcimbi
• Imibiko
• Yabelana Ngedatha Yami
• Umhlahlandlela Wokubeka
• Xhuma
• Izilungiselelo
• Mayelana

Izexwayiso

• KOKUBILI idivayisi yakho yeselula nesidlulisi esihlakaniphile kunikeza izexwayiso zokukwazisa uma ukufundwa kwe-CGM yakho sekufinyelele izilungiselelo ezithile eziqondiwe noma uma Uhlelo lwakho lwe-CGM ludinga ukunakwa.
• Bona Umhlahlandlela Womsebenzisi ukuze uthole uhlu oluphelele lwezaziso kuhlelo lwakho lokusebenza.

Ukubeka i-Smart Transmitter yakho

1. Khipha iphepha elisekela ngelogo ye-Eversense bese ubeka isidluliseli esihlakaniphile phakathi nendawo
2. Susa isipele esikhulu esicacile futhi ubeke isidlulisi esihlakaniphile phezu kwenzwa.
3. Hlola ukuxhumana phakathi kwe-smart transmitter kanye nenzwa.Khetha Umhlahlandlela Wokubeka Kokudonsela phansi kwe-Main Menu ukuze ikusize unqume ukuthi ungasibeka kuphi isidlulisilwazi sakho esihlakaniphile. Shelelezisa isidluliseli esihlakaniphile phezu kwendawo yokufaka inzwa uze uthole isignali enhle noma eqinile kuhlelo lokusebenza.
4. Cindezela i-adhesive patch ngokuqinile endaweni yesikhumba phezu kwenzwa.
5. Sebenzisa ithebhu ukukhipha ulayini ocacile osele.

Ukuxhumanisa inzwa ne-Smart Transmitter

Uma inzwa isifakwe umhlinzeki wakho wokunakekelwa kwezempilo, inzwa yakho izodinga ukuxhunyaniswa nesidlulisi sakho esihlakaniphile.

1. Misa isidluliseli esihlakaniphile ngokuqondile phezu kwenzwa efakiwe kuze kube yilapho isidluliseli esihlakaniphile siyeka ukudlidliza futhi kuvela umlayezo Otholwe Inzwa Entsha kuhlelo lokusebenza.
2. Thepha Inzwa Yesixhumanisi bese Uxhumanisa Inzwa Etholiwe.
3. Uma isidlulisilwazi esihlakaniphile nenzwa kuxhunywa ngempumelelo, isikrini se-LINKED SENSOR sibonisa inombolo ye-ID yenzwa

Isigaba Sokufudumeza Samahora angu-24 siqala uma usuxhumanise inzwa yakho. Ungacisha i-smart transmitter kuze kuphele Isigaba Sokufudumala. Inzwa idinga amahora angama-24 ukuze izinze emzimbeni wakho ngaphambi kokuthi isidluliseli esihlakaniphile sibale amanani eglucose. Ukuze uthole ulwazi olwengeziwe, sicela uphindeview isigaba esinesihloko Ukulinganisa Uhlelo kweyakho I-Eversense CGM System User Guide.

Kusatshalaliswe ngu: I-Ascensia Diabetes Care US, Inc. 5 Wood Hollow Road Parsippany, NJ 07054 USA 844.SENSE4U (844.736.7348)  www.ascensia.com/eversense

Kwenziwe by: Senseonics, Inc. 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 USA

Amahora Wokusekela Amakhasimende: 8am to 8pm (Eastern US Time)  www.eversensediabetes.com

Amalungelo obunikazi: www.senseonics.com/products/patents

I-Apple App Store ne-Google Play kanye nemikhiqizo yazo yizimpawu zokuthengisa noma amalungelo okukopisha abanikazi bazo.

© Senseonics, Inc. 2023 PN: LBL-1603-01-001 Rev M 04/2023

 

 

Amadokhumenti / Izinsiza

I-eversense Isistimu Yokuqapha I-Glucose Eqhubekayo [pdf] Umhlahlandlela Womsebenzisi Isistimu Yokuqapha I-Glucose Eqhubekayo, Isistimu Yokuqapha I-Glucose, Isistimu Yokuqapha, Isistimu

Izithenjwa

• Imaniwali yosebenzisayo