Contour Next, blood glucose monitoring tool

Contour Next - Blood Glucose Monitoring Tool
Contour Next is a miniaturized instrument for the determination of blood glucose on capillary and venous whole blood. The system uses Contour Next sensor electrode test strips.

The Contour Next system meets all the requirements of the ISO 15197:2013 standard, transposed into the Official Journal as EN ISO 15197:2015.

Blood glucose monitoring with the Contour Next instrument and with the Contour Nextri test strips is easy, simple and accurate, thanks above all to the Automatic Coding of the instrument.

Contour Next is extremely easy, intuitive and practical to use:
• small blood sample 0.6 μL (microliters)
• 5-second test execution (countdown)
• Large display and only 3 buttons
•ergonomic
• equipped with SmartLight function - target range indicator - with colored light directly on the instrument to indicate the results (in target - green light, above target - yellow light, below target - red light).
• equipped with connection to the dedicated Contour Diabetes app via Bluetooth.

TEST PRINCIPLE
The Contour Next test strips have been developed on the basis of the latest technology on the market (the sensor electrode).

They use a small amount of blood (0.6 μL) which is automatically aspirated by capillary within the reactive end of the strip: after a 5-second countdown, the concentration of glucose present in the blood sample automatically appears on the display.

The glucose in the blood sample is determined through a reaction with the FAD glucose dehydrogenase (FAD-GDH) and mediator, which generates electrons that produce a current directly proportional to the glucose content in the sample.
Contour Next strips enable glucose determination on capillary and venous whole blood.
The results obtained are directly comparable with analysis methods using plasma/serum and are not significantly affected by hematocrit (in levels in the range of 0-70%).

INTERFERENCE
The Contour Next System has been tested against the following potentially interfering substances that occur naturally in the blood: bilirubin, creatinine, galactose, glutathione, hemoglobin, triglycerides, and uric acid.

No interfering effect was observed for any substance at the highest concentration either at the common pathological level or up to 3 times the limit of the upper level of the normal range.

The Contour Next System has been tested for the following potentially interfering substances found in the blood following therapeutic treatment: ascorbic acid, acetaminophen (acetaminophen), dopamine, sodium gentisate, ibuprofen, icodextrin, levodopa, maltose, methyldopa, pralidoxime iodide, sodium salicylate, tolbutamide.
No interfering effect was observed for any substance, at the upper level of toxicity concentration or 3 times the maximum therapeutic concentration.
Xylose: Do not use during or immediately after xylose absorption tests. Xylose in the blood causes interference.
Neonatal blood: The instrument is not suitable for neonatal use.
For more information, please refer to the Contour Next test strip leaflet.

ANALYTICAL PERFORMANCE
All analytical performance evaluations have been carried out in accordance with International Standard EN ISO 15197:2015, the results are reported below with the references of the paragraphs of the standard.
Accuracy (Minimum System Performance Criteria, par. 6.3.3)
The Contour Next blood glucose monitoring system was tested on 100 capillary blood samples, using 600 Contour Next test strips. Duplicate replicas were performed with 3 batches of Contour Next test strips. The results were compared to the reference laboratory method YSI Glucose Analyzer, traceable to CDC's hexokinase method.

For the Contour Next System, 100% of results fall within the range of ±15 mg/dL for blood glucose below 100 mg/dL and within ±15% for blood glucose greater than or equal to 100 mg/dL.

EXPORT, GRAPHIC PROCESSING AND TRANSMISSION OF DATA TO THE CLINICIAN
Contour Next can be connected to a computer to view and analyze the stored glucose data, thanks to the use of the GLUCOFACTS DELUXE software.

GLUCOFACTS DELUXE
It allows people with diabetes to share data with their doctor both by printing the diary and the various graphs, and by saving them in PDF or CSV format and sending them by e-mail.
GLUCOFACTS DELUXE allows the clinician to download data from the instrument to their PC and analyze the data of each individual patient, with descriptive statistics such as mean and standard deviation. The downloaded data are stacked in the different customizable time slots (minimum 2, maximum 5), grouped as pre-meal (apple),
post-meal (apple eaten) or without any indicator (nothing), and are highlighted with different colors depending on whether they fall within the target range (green), below target (orange) or above target (yellow). The software allows you to view the summary table of all the downloaded data, the table includes the following statistics: number of tests performed, standard deviation, average, minimum and maximum value for each band.

Data download cable ( NOT INCLUDED IN THE PRODUCT):
by contacting Customer Service, the person with diabetes or the institution can request and receive the cable free of charge.

INTEGRATION OF THE DATA FLOW WITH DIFFERENT MEDICAL RECORDS
It is possible to export the data for subsequent processing in the following computerized medical records commonly used in diabetes centers: MyStar Connect (Smart Digital Clinic) and Diasend.

- Memory - stores the last 800 test results
- Countdown duration - 5 seconds
- Sample volume - 0.6 μL
- Second-Chance sampling technology - 60 seconds to apply more blood to the same test strip
- Data management via app - the CONTOUR DIABETES app is available for compatible devices Android from version 5.0 and iOS from version 10.0. For the list of compatible devices
- Data download via port - Yes
- Test strips - CONTOUR NEXT test strips
- Measurement range - 10 - 600 mg/dL blood glucose

Dimensions: 78.5 mm (W) x 56 mm (H) x 18 mm (D)
Weight: 53 grams

Colored target indicators (smartLIGHT)
The smartLIGHT feature provides quick feedback on your blood glucose results.
Second-Chance sampling technology - 60 seconds: A countdown timer indicates that you have 60 seconds to apply more blood to the same test strip

Connect to the free CONTOUR DIABETES app
The free CONTOUR DIABETES app is available to support you in managing your diabetes, providing you with a detailed overview of your results.

Easy to use: automatically syncs to your instrument generating a detailed electronic diary of your results

Easy to understand: The "Trends" feature helps you identify specific trends in your blood glucose results, and sends you notifications about possible causes

Easy to share: the blood glucose diary can be sent to your healthcare provider even before the visit.

Easy to use
- No initial setup
- Customizable target ranges
- Wide, easy-to-use rubber keys
- Large numbers on the display

- Blood glucose monitoring tool
- 10 test strips
- Lancing device
- 10 colored hands
- User manual
- Quick Start Guide
-Custody
- Guarantee card