Ascensia Diabetes Care Contour Next GEN Blood Glucose Monitoring System

Intended Use

The Contour Next GEN blood glucose monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The system is intended for single-person use and should not be shared. It is not intended for the diagnosis of or screening for diabetes or for neonatal use.

This document uses the term ‘blood glucose’ to mean ‘blood sugar’.

The Contour Next GEN blood glucose meter is not intended for use with Alternative Site Testing (AST).

About Meal Markers

Meal Markers can be attached to blood glucose results when the feature is turned On. Your meter comes with Meal Markers turned Off, but they can be enabled in Settings.

Do not press the tip of the test strip against the skin or place the blood on top of the test strip. This could lead to inaccurate results or errors.

Second-Chance Sampling: Apply More Blood

If the meter beeps twice and displays a blinking blood drop with a plus sign (?➕), the test strip does not have enough blood. Apply more blood to the same test strip within 60 seconds. If an E1 error message is displayed, remove the strip and start with a new one.

Add a Meal Marker to a Reading

During a blood glucose test, if Meal Markers are On, you can select a Meal Marker when the meter displays your result. You cannot select a Meal Marker in the Settings screen.

Example: After a test result is displayed (e.g., 118), do not press OK or remove the test strip yet. You can select the blinking marker or choose a different Meal Marker by pressing the scroll buttons (⬆️/⬇️) and then pressing OK.

To turn Meal Markers On, see Section 4 Settings: Set Meal Marker Feature.

Important Safety Information & Precautions

• Read your Contour Next GEN user guide, the lancing device package insert (if provided), and all instructional materials before testing.
• Examine the product for missing, damaged, or broken parts. Do not use test strips if their packaging is open or damaged.
• Your Contour Next GEN meter works ONLY with Contour Next blood glucose test strips and Contour Next control solution.
• Always keep test strips in their original bottle or foil packet. Tightly close the bottle immediately after removing a strip. Do not store other items or medications in the test strip bottle. Avoid exposing the meter and test strips to excessive humidity, heat, cold, dust, or dirt. Exposure to room humidity by leaving the bottle open or not storing strips properly can damage them and lead to inaccurate results.
• Do not use expired materials. Always check expiration dates.
• Do not use control solution that is more than 6 months past the date it was first opened.
• If your control solution test result is out of range, contact Customer Service and do not use the meter for blood glucose testing until the issue is resolved.
• The meter operates accurately between 41°F and 113°F. Allow approximately 20 minutes for the meter to adjust to the temperature of a new location before testing.
• Do not attempt to perform a blood glucose test when the meter is connected to a computer.
• Use only approved equipment (e.g., USB cable) from the manufacturer or certified bodies (UL, CSA, TUV, CE).
• Results are displayed in mg/dL (milligrams of glucose per deciliter of blood) without a decimal point.
• The measuring range is 20 mg/dL to 600 mg/dL.
• LO screen: If the meter displays LO, your blood glucose reading is under 20 mg/dL. Contact your health care professional immediately.
• HI screen: If the meter displays HI, your blood glucose reading is over 600 mg/dL. Wash your hands or the test site and repeat the test with a new strip. If the meter again displays HI, follow medical advice immediately.

Potential Biohazard: All parts of the kit are considered biohazardous. Always wash hands with antibacterial soap and water and dry them well before and after testing or handling the meter, lancing device, or test strips. If a second person assists with testing, the meter and lancing device should be disinfected prior to use by the second person. Dispose of used test strips and lancets as medical waste.

1 GETTING STARTED

The Contour Next GEN blood glucose monitoring system consists of the Contour Next GEN meter, Contour Next blood glucose test strips, and the Contour Diabetes app.

Meter Components

• Test Strip Port: Grey square end inserts here.
• Test Strip Port Light: Illuminates when a strip is inserted.
• Sample Tip: Blood sample is pulled in here.
• OK Button: Press to accept a selection or turn the meter on/off (press and hold).
• Scroll Buttons (⬆️/⬇️): Press to scroll up or down; press and hold to keep scrolling.

Check the Meter Display

Press and hold the OK button until the meter turns on (approx. 3 seconds). The screen displays the Power On Self Test (888888). Verify that all symbols are displayed and the test strip port light is white. If there are missing characters or the light is not white, contact Customer Service.

Your meter comes with a pre-set time, date, and target range. These can be changed in Settings (Section 4).

Your Meter Symbols

The Home Screen

The Home screen has 2 options: Logbook (?) and Settings (⚙️). Press the scroll buttons (⬆️/⬇️) to highlight an option. Press OK (✅) while the symbol is blinking to enter Logbook or Settings.

2 TESTING

Get Ready to Test

• Read your user guide, lancing device insert, and all instructional materials.
• Examine product for damaged parts. Do not use damaged test strips.
• Ensure you have the necessary materials: Contour Next GEN meter, Contour Next blood glucose test strips, lancing device and lancets.
• For quality control, see Section 5 Help: Control Solution Testing.

Your Contour Next GEN meter works only with Contour Next blood glucose test strips and Contour Next control solution.

Symptoms of High / Low Blood Glucose

Low blood glucose (Hypoglycemia): shakiness, sweating, fast heartbeat, blurred vision, confusion, passing out, seizure, irritability, extreme hunger, dizziness.

High blood glucose (Hyperglycemia): frequent urination, excessive thirst, blurred vision, increased fatigue, hunger.

Ketones (Ketoacidosis): shortness of breath, nausea or vomiting, very dry mouth.

If you are experiencing any of these symptoms, test your blood glucose. If your result is under the critical level or over the recommended limit established with your health care professional, follow their advice immediately.

Fingertip Testing

Prepare the Lancing Device: Refer to your lancing device insert for detailed instructions.

Insert the Test Strip:

1. Remove a Contour Next blood glucose test strip.
2. Insert the grey square end firmly into the test strip port until the meter beeps.
3. The screen displays a blinking blood drop (?), indicating it is ready to test.

After inserting the strip, apply blood within 3 minutes, or the meter turns off. Remove and reinsert the strip to start a new test.

Get the Blood Drop:

1. Press the lancing device firmly against the puncture site and press the release button.
2. Immediately touch the tip of the test strip to the drop of blood. The blood is drawn into the test strip through the tip.
3. Hold the tip of the test strip in the blood drop until the meter beeps.

If the Meal Marker feature is On, do not remove the test strip until you select a Meal Marker.

Second-Chance Sampling: If the meter displays a blinking blood drop with a plus sign (?➕), apply more blood to the same test strip within 60 seconds.

Add a Meal Marker to a Reading: When the meter displays your result, you can select a Meal Marker (Fasting, Before Meal, After Meal, No Mark) by scrolling with the buttons (⬆️/⬇️) and pressing OK (✅). If this is a Before Meal reading, you can set a Reminder.

If no Meal Marker is selected within 3 minutes, the reading is stored without a marker.

Set a Test Reminder:

1. Ensure the Reminder feature is On in Settings.
2. Mark a reading as Before Meal and press OK.
3. Scroll using the buttons (⬆️/⬇️) to set the reminder time (e.g., 0.5, 1, 1.5, 2 hours).
4. Press OK to set the Reminder. The Reminder symbol (i) will appear.

smartLIGHT Target Range Indicator: After a test, the meter displays the result with units, time, date, meal marker, and a target range symbol (Above Target ⬆️, In Target ✔️, Below Target ❌). If smartLIGHT is On, the test strip port light displays a color: Yellow (Above Target), Green (In Target), Red (Below Target).

If your blood glucose result is below target, the smartLIGHT is red and the meter beeps twice.

To change a Meal Marker or Target Range, use the Contour Diabetes app or navigate through the meter's Settings.

Test Results

Always consult your health care professional before changing medication based on test results or if results are inconsistent with how you feel. If your blood glucose reading is under the critical level or over the recommended limit, follow your health care professional’s advice immediately.

Expected Test Result Values: Blood glucose values vary. Nondiabetic plasma glucose concentrations should be less than 100 mg/dL fasting and less than 140 mg/dL postprandial. Consult your health care professional for your specific target values.

LO or HI Results:

• LO screen: Reading is under 20 mg/dL. Contact your health care professional immediately.
• HI screen: Reading is over 600 mg/dL. Wash hands/test site, retest with a new strip. If HI persists, follow medical advice immediately.

Eject and Dispose of the Used Lancet: Do not use fingers to remove the lancet. Refer to the lancing device insert for automatic ejection instructions. Dispose of used test strips and lancets as medical waste.

Potential Biohazard: The lancing device, lancets, and test strips are for single-patient use only. Do not share. Handle all products that come in contact with blood as if capable of transmitting infectious diseases. Always wash hands and dispose of used items properly.

3 LOGBOOK

The Logbook stores up to 800 blood glucose test results and their Meal Markers. When the Logbook is full, the oldest result is removed as a new one is saved.

Review the Logbook

From the Home screen, select the Logbook symbol (?) and press OK (✅). Use the scroll buttons (⬆️/⬇️) to view individual test results. Press and hold the buttons to scroll faster.

View Averages

From the Logbook screen, press the scroll button (⬆️) to view Averages. You can scroll through 7-, 14-, 30-, and 90-day averages by pressing the scroll buttons (⬆️/⬇️). Press OK (✅) to return to the Home screen.

When you scroll past the oldest entry, the meter displays the End screen. Press OK to go to the Home screen and select the Logbook symbol to review entries from the beginning.

4 SETTINGS

In Settings, you can personalize your meter:

• Time format and time
• Date format and date
• Sound (On/Off)
• Meal Markers (On/Off)
• Reminder feature (On/Off)
• Target Ranges (Before Meal, After Meal, Overall)
• smartLIGHT feature (On/Off)
• Bluetooth wireless functionality (On/Off)

Press OK (✅) to accept the current or changed setting before moving to the next setting.

Access Settings

From the Home screen, highlight the Settings symbol (⚙️) and press OK (✅). Scroll through the Settings options using the buttons (⬆️/⬇️) until the desired symbol is blinking, then press OK (✅).

Change the Time

1. Enter Settings, then highlight the Time symbol and press OK.
2. The time format (12h/24h) blinks. Press (⬆️/⬇️) to select the desired format, then press OK.
3. The hour blinks. Press (⬆️/⬇️) to change the hour, then press OK.
4. The minutes blink. Press (⬆️/⬇️) to change the minutes, then press OK.
5. For 12-hour format, select AM or PM as needed, then press OK.

Change the Date

1. Enter Settings, then highlight the Date symbol and press OK.
2. The date format (m/d or d.m) blinks. Press (⬆️/⬇️) to select the desired format, then press OK.
3. The year blinks. Press (⬆️/⬇️) to change the year, then press OK.
4. The month blinks. Press (⬆️/⬇️) to change the month, then press OK.
5. The day blinks. Press (⬆️/⬇️) to change the day, then press OK.

Set the Sound

1. Enter Settings, highlight the Sound symbol (?) and press OK.
2. Press (⬆️/⬇️) to turn Sound On or Off, then press OK.

Your meter comes with Sound On. Some error messages override the Sound setting. To turn off sounds for a below-target reading, turn the smartLIGHT feature Off.

Set Meal Marker Feature

1. Enter Settings, highlight the Meal Marker symbols and press OK.
2. Press (⬆️/⬇️) to turn Meal Markers On or Off, then press OK.

When Meal Markers are On, you can select a marker during a blood glucose test.

Set Reminder Feature

1. Enter Settings, highlight the Reminder symbol (i) and press OK.
2. Press (⬆️/⬇️) to turn the Reminder feature On or Off, then press OK.

Your meter comes with the Reminder feature turned Off.

Change Target Ranges

You can change the Before Meal/After Meal and Overall Target Ranges.

Change Overall Target Range

1. Enter Settings, highlight the Target Range symbol (e.g., 70-180) and press OK.
2. The Low end of the Overall Target Range blinks. Press (⬆️/⬇️) to adjust, then press OK.
3. The High end blinks. Press (⬆️/⬇️) to adjust, then press OK.

Change Before/After Meal Target Ranges

1. Enter Settings, highlight the Target Range symbol and press OK.
2. The Before Meal/After Meal Low Target blinks (e.g., 70). Press (⬆️/⬇️) to adjust, then press OK. (Note: There is one Low number for both ranges).
3. The Before Meal High Target blinks (e.g., 130). Press (⬆️/⬇️) to adjust, then press OK.
4. The After Meal High Target blinks (e.g., 180). Press (⬆️/⬇️) to adjust, then press OK.

Discuss your Target Range settings with your health care professional.

Set smartLIGHT Target Range Indicator

1. Enter Settings, highlight the smartLIGHT symbol and press OK.
2. Press (⬆️/⬇️) to turn the smartLIGHT feature On or Off, then press OK.

Your meter comes with smartLIGHT On. Yellow means Above Target, Green means In Target, Red means Below Target.

Set Bluetooth Wireless Functionality

1. Enter Settings, highlight the Bluetooth symbol (?) and press OK.
2. Press (⬆️/⬇️) to turn Bluetooth wireless functionality On or Off, then press OK.

Download the Contour Diabetes app

On your smartphone or tablet, go to the App Store® or Google Play™ store, search for the Contour Diabetes app, and install it.

Pairing Mode

To pair your meter with the Contour Diabetes app:

1. Turn on your meter by pressing and holding OK.
2. Press and HOLD the scroll button (⬇️) for about 3 seconds until the Bluetooth symbol (?) blinks. A blue light blinks when in pairing mode.
3. When the meter displays the serial number, follow the app instructions to match the meter serial number. A pass code will be displayed on the meter for entry into the app.
4. When successfully paired, the meter displays a blue light and the Bluetooth symbol (?). The meter returns to the Home screen.

The Contour Next GEN meter has not been tested for use with any software other than compatible Ascensia Diabetes Care software. The manufacturer is not responsible for erroneous results from other software.

There is a remote possibility that a computer specialist could listen in on wireless communications during pairing. Pair your meter away from other people if you believe this is a risk. After pairing, this precaution is not needed.

Target Ranges can be updated from the meter or the app. The most recently changed ranges will sync.

5 HELP

Meter Care

• Store the meter in the provided carrying case.
• Wash and dry hands well before handling to keep the meter and test strips free of contaminants.
• Handle the meter carefully to avoid damage.
• Avoid exposing the meter and test strips to excessive humidity, heat, cold, dust, or dirt.
• Clean and disinfect your meter weekly.

The meter has been tested for 260 cleaning/disinfection cycles (5 years of weekly use).

Cleaning Your Meter

Use Clorox Healthcare Bleach Germicidal Wipes (EPA #67619-12) containing 0.55% sodium hypochlorite.

1. Clean the meter with germicidal wipes until all soil is removed.
2. Dry with a clean paper towel.

Do not allow cleaning solution to run into the meter through open areas.

Disinfecting Your Meter

1. Clean the meter as described above.
2. Using a new germicidal wipe, carefully wipe all outer surfaces until wet. Keep all meter surfaces wet for 60 seconds for proper disinfection.
3. After 60 seconds, use a clean paper towel to dry the meter surfaces and the test strip port.

Potential Biohazard: All parts are biohazardous. Always wash hands and dispose of used items properly. Keep batteries away from children.

Replace Meter Batteries

1. Turn off the meter.
2. Slide the battery cover open.
3. Remove old batteries and insert two new 3-volt CR2032 or DL2032 coin cell batteries, ensuring the '+' sign faces up.
4. Slide the battery cover back into place.
5. Discard old batteries according to local regulations.

Keep batteries away from children. Many types of batteries are poisonous. If swallowed, contact a poison control center immediately.

Control Solution

Use only Contour Next control solution (Level 1 and Level 2) with your Contour Next GEN system. Using other solutions can cause inaccurate results.

Perform a control test when:

• You think your test strip may be damaged.
• You think your meter may not be working properly.
• You have repeated, unexpected blood glucose results.

Shake the control solution well before testing.

Do not use control solution that is more than 6 months past the date you first opened the bottle.

Control Solution Testing

1. Remove a Contour Next blood glucose test strip.
2. Insert the grey square end into the test strip port until the meter beeps. The meter turns on, displaying a test strip with a flashing blood drop.
3. Shake the control solution bottle well (approx. 15 times) before every use.
4. Wipe the bottle tip and dispense a small drop of solution onto a clean, nonabsorbent surface.
5. Immediately touch the tip of the test strip to the drop of control solution. Hold until the meter beeps.
6. Compare your control test result with the range printed on the test strip bottle or box.
7. Remove and dispose of the test strip.

If your control test result is out of range, contact Customer Service. Do not use the meter for blood glucose testing until the issue is resolved.

If this is the first time opening the control solution, write the date on the bottle.

Transfer Results to a Personal Computer

Test results can be transferred to a computer using diabetes management software and a USB-A to Micro USB-B cable. Ensure the meter’s USB port door is completely closed when not in use.

Do not attempt to perform a blood glucose test when the meter is connected to a computer.

6 TECHNICAL INFORMATION

Error Detection Displays

The meter displays error codes (E plus a number) for test result, strip, or system errors. When an error occurs, the meter beeps twice and displays the code. Press OK to turn off the meter.

Meter Kit Contents

The following parts are included in the meter kit:

• Contour Next GEN blood glucose meter (with two 3-volt CR2032 or DL2032 coin cell batteries)
• Contour Next GEN user guide
• Contour Next GEN quick reference guide
• Contour Next blood glucose test strips*
• Contour Next control solution*
• Microlet® next lancing device*
• Microlet® lancets*
• Carrying case

*Required parts that may not be included in your kit.

System Accuracy and Precision

Accuracy: The Contour Next GEN meter results are compared to an approved lab instrument. The table below shows the percentage of measurements within specified differences.

Precision: Intermediate measurement precision was evaluated using control solutions at 5 glucose levels.

Specifications

• Test Sample: Capillary whole blood only
• Test Result: Referenced to plasma/serum glucose
• Sample Volume: 0.6 μL
• Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood
• Countdown Time: 5 seconds
• Memory: Stores most recent 800 test results
• Battery Type: Two 3-volt CR2032 or DL2032 coin cell batteries
• Battery Life: Approximately 1000 tests (1 yr. average use, 3 tests per day)
• Meter Operating Temperature Range: 41°F–113°F
• Control Testing Temperature Range: 59°F–95°F
• Meter Operating Humidity Range: 10% RH–93% RH
• Test Strip Storage Conditions: 41°F–86°F, 10%–80% Relative Humidity (RH)
• Dimensions: 78.5 mm (L) x 56 mm (W) x 18 mm (H)
• Weight: 53 grams
• Meter Life: 5 years with normal use
• Sound Output: 45 dB(A)–85 dB(A) at 10 cm
• Radio Frequency Technology: Bluetooth Low Energy
• Radio Frequency Band: 2.4 GHz–2.483 GHz
• Maximum Radio Transmitter Power: 1 mW
• Modulation: Gaussian Frequency Shift Keying (GFSK)
• Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2 Edition 4.0.

Product Labeling Symbols

Various symbols are used on product labeling, including:

• Discard Date: Indicates the date after which the medical device is not to be used.
• Shake 15 times: Instruction for preparing control solution.
• UDI (Unique device identifier): Carrier containing unique device identifier information.
• Catalog or model number: Manufacturer’s catalog number.
• Batch Code: Manufacturer’s batch code.
• In Vitro Diagnostic Medical Device: Indicates intended use.
• Temperature limit: Indicates safe temperature exposure limits.
• Control: Indicates control material for performance verification.
• Consult instructions for use: Advises user to consult instructions.
• Caution: Read all warnings and precautions: Advises user to consult instructions for important cautionary information.
• Do not re-use: Indicates single use or use on a single patient.
• Sterilized using irradiation: Indicates sterilization method.

Principles of the Procedure

The Contour Next GEN blood glucose test measures electrical current generated by the reaction of glucose with reagents on the test strip electrode. Blood sample is drawn into the tip via capillary action. Glucose reacts with FAD glucose dehydrogenase (FAD-GDH) and a mediator, producing a current proportional to glucose concentration. The glucose concentration is displayed after the reaction time.

Comparison Options

The Contour Next GEN system is designed for capillary whole blood. Comparison with a laboratory method must be done simultaneously with aliquots of the same sample. Glucose concentrations drop rapidly due to glycolysis (approx. 5%–7% per hour).

References

References are provided for further information on safety, accuracy, and technical standards, including sources from the US Food and Drug Administration, Centers for Disease Control and Prevention, and various ISO/IEC standards.

Third Party Notices

Attribution notices for third-party software components licensed under the Apache License 2.0, including Cortex Microcontroller Software Interface Standard (CMSIS) and Mbed TLS, are included.

Contact Information

Customer Service is available Monday through Sunday, 8:00 am – 12:00 Midnight, Eastern Time.

For medical emergencies, contact your health care professional or dial 911.

Distributed by: Ascensia Diabetes Care US Inc.

5 Wood Hollow Road, Parsippany, NJ 07054

Website: www.diabetes.ascensia.com

Customer Service: 1-800-348-8100

Patent Information: www.patents.ascensia.com

Trademarks mentioned include Ascensia, Contour, Microlet, Second-Chance, Smartcolor, Smartlight, Apple, App Store, Bluetooth®, Google Play, and Google Play logo.