9/9/2023 0 Comments Contour next one connect to pc![]() ![]() In vitro diagnostic test systems - requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197). International Organization for Standardization. CONTOUR ®NEXT ONE BGMS User Guide Rev 08/19.Ģ. †In a clinical study, conducted in accordance with the requirements of ISO 15197:2013, the CONTOUR ®NEXT ONE not only met and exceeded the minimum requirements of the standard but an ad hoc analysis determined where 95% of results fell during the study, which was within ☐.47 mmol/L or ☘.4% of the laboratory reference value for glucose concentrations <5.55 mmol/L or ≥5.55 mmol/L, respectively, when tested via subject obtained capillary fingertip results (patients with diabetes)ġ. 99% of individual glucose measured values need to fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. ***95% of the measured glucose values needed to fall within either ☐.83 mmol/L (☑5 mg/dL) of the average measured values of the reference measurement procedure at glucose concentrations <5.55 mmol/L (<100 mg/dL) or within ☑5% at glucose concentrations ≥5.55 mmol/L (≥100 mg/dL). For a list of compatible operating systems, please visit **On a compatible Android or iOS operating system. ![]() Diabetes Technology Society DTSec Contour NEXT DTSec certificate.*Before use please see the CONTOUR ®NEXT ONE user guide for full instructions Poster presented at the 78th Scientific Session of the American Diabetes Association (ADA) June 22-26, 2018 Orlando, Florida.ĥ. User Experience With the Information–Motivation–Behavioral Skills (IMB)–Based CONTOUR ®NEXT ONE Smart Meter and App System (v0.1). International Organization for Standardization, Geneva, Switzerland, 2013.ģ. Pleus S et.al, User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results. Please contact our local customer service team on 1800 289 312 if you have a request outside of these guidelines.ġ. Requests for more than one meter in this period may not be accepted at the sole discretion of Ascensia Diabetes Care. § Terms and conditions apply: Upgrades to Contour Next are limited to one (1) per NDSS registrant in an 18 month period. ![]() Cable connection and Bluetooth connections are both possible for the full range of CONTOUR ® blood glucose monitoring systems. ‡ Data can still be uploaded from a non-connected meter. For a list of compatible devices, please visit ** Patients need to be registered in GlucoContro.online and approve sharing their data with their healthcare professional. SdNcenter is the legal manufacturer and developer of GlucoContro.online and is partnering with Ascensia to market and deliver the tool to HCP and Patient users † An ad hoc analysis demonstrated that 95% of the results were within the error range ☐.3 mmol/L or ±5.3% of the laboratory reference values (Hexokinase (HK)-based method (Cobas Integra 400 Plus Roche Instrument Center, Rotkreuz, Switzerland). * Minimum accuracy requirements of ISO15197: 2013 Section 6.3 standard require ≥95% of the measured values to fall within ☐.83 mmol/L at glucose concentrations <5.5 mmol/L or within ☑5% at glucose concentrations ≥5.5 mmol/L compared to the reference method. ![]()
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