Blood Glucose Monitoring System

Works with free Contour®Diabetes app.

Warranty information and online meter registration available at www.diabetes.ascensia.com/warranty or call our Customer Service.

Uses only Contour®Next blood glucose test strips.

Contour Next GEN User Guide (Pamphlet)

Table of Contents

INTENDED USE

The Contour Next GEN blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Contour Next GEN blood glucose monitoring system is intended to be used by a single person and should not be shared. The Contour Next GEN blood glucose monitoring system 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 Contour Next GEN blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. The Contour Next blood glucose test strips are for use with the Contour®Next GEN blood glucose meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips.

The system is intended for in vitro diagnostic use only.

NOTE: This document uses the term 'blood glucose' to mean 'blood sugar'.

IMPORTANT SAFETY INFORMATION

Potential Biohazard

• The meter and lancing device are for single-patient use. Do not share them with anyone including other family members! Do not use on multiple patients.^1,2
• The lancing device usually provided with your kit should not be used for assisted blood draws by health care professionals or at health care provision sites.
• Always dispose of used test strips and lancets as medical waste or as advised by your health care professional.
• All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.
• Keep out of reach of children. This kit contains small parts that could cause suffocation if accidentally swallowed.
• Keep batteries away from children. Many types of batteries are poisonous. If swallowed, immediately contact your poison control center.
• This device is not intended for use in healthcare or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures.
• Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

Limitations

• Serious Illness: The system should not be used to test critically ill patients and should not be used by persons with reduced peripheral blood flow. Inaccurate results may occur in severely hypotensive individuals, those dehydrated or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoxia state, or a hyperglycemic-hyperosmolar state, with or without ketosis.^3,4
• Meter Operating Temperature Range: 41°F–113°F
• Meter Storage Temperature Range: -4°F–149°F
• Meter Operating Humidity Range: 10% RH–93% RH
• Control Testing Temperature Range: 59°F–95°F
• Test Strip Storage Conditions: 41°F–86°F, 10%–80% Relative Humidity (RH)
• Second-Chance® sampling conditions: Temperature Range 59°F–95°F, Hematocrit 20%–55%
• Sample Volume: 0.6 μL
• Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood
• Altitude: This system has not been tested at altitudes higher than 20,674 feet (6,301 meters).
• Hematocrit: Contour Next blood glucose test strip results are not significantly affected by hematocrit levels in the range of 20% to 55%.
• Xylose: Do not use during or soon after xylose absorption testing. Xylose in the blood will cause an interference.
• Neonatal Use: The Contour Next GEN meter is not indicated for neonatal use.

PRECAUTIONS

• Read your Contour Next GEN user guide, the lancing device package insert, if provided, and all instructional materials provided in your meter kit before testing. Follow all instructions for use and care exactly as described to help avoid inaccurate results.
• Examine the product for missing, damaged, or broken parts. If the test strip packaging is open or damaged, do not use those test strips.
• Your Contour Next GEN meter works ONLY with Contour Next blood glucose test strips and Contour®Next control solution.
• Always keep the Contour Next blood glucose test strips in their original bottle or foil packet. Tightly close the bottle immediately after removing a test strip. The bottle is designed to keep the test strips dry. Do not place or store other items or medications in the test strip bottle. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, or dirt.
• Do not use expired materials. Using expired material can cause inaccurate results. Always check the expiration dates on your test materials.
• If this is the first time you are opening the control solution, write the date on the bottle. Do not use control solution that is more than 6 months past the date you first opened the bottle.
• If your control solution test result is out of range, contact Customer Service. Do not use the meter for blood glucose testing until you resolve this issue.
• The meter is designed to give accurate blood testing results at temperatures between 41°F and 113°F. If the meter or test strip is outside this range, you should not test until the meter and test strip are within this range.
• Do not attempt to perform a blood glucose test when the Contour Next GEN meter is connected to a computer.
• Use only approved equipment (for example, USB cable) from the manufacturer or certified body such as UL, CSA, TUV, or CE.

Your Contour Next GEN meter has been preset and locked to display results in mg/dL (milligrams of glucose per deciliter of blood).

• Results in mg/dL do not have a decimal point.
• Results in mmol/L have a decimal point.

mg/dL

or

mmol/L

The Contour Next GEN blood glucose monitoring system has a measuring range of 20 mg/dL to 600 mg/dL.

• For results under 20 mg/dL or over 600 mg/dL:
  • If your meter does not display a value and displays the LO screen, contact your health care professional immediately.
  • If your meter does not display a value and displays the HI screen, wash your hands or the test site and repeat the test with a new strip. If the meter again displays the HI screen, follow medical advice immediately.

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.

Your Contour Next GEN meter and Contour Next blood glucose test strip

• To exit from the Logbook or Averages and return to the Home screen, press OK.
• When a symbol is blinking, you can select it.

Check the Meter Display

Press and hold OK until the meter turns on, about 3 seconds. The screen displays the Power On Self Test.

All symbols on the screen and the white test strip port briefly light up. Verify that the meter screen fully displays 8.8.8 and that the white light from the test strip port is visible. If there are missing characters or if the strip port light is a color other than white, contact Customer Service.

NOTE: Your meter comes with a pre-set time, date, and target range. You can change these features in Settings. See Section 4 Settings.

Your Meter Symbols

Symbol	What the Symbol Means
	Yellow Light: test result is above Target Range.
	Green Light: test result is in Target Range.
	Red Light: test result is below Target Range.
	Test result is above Target Range.
	Test result is in Target Range.
	Test result is below Target Range.
	Test result is above 600 mg/dL.
	Test result is below 20 mg/dL.
	Your Logbook.
	Meter Settings.
	Fasting marker.
	Before Meal marker.
	After Meal marker.
	No marker selected.
	A Target Range or Target Range setting.
	smartLIGHT™ target range indicator setting.
	Meter is ready to test.
	Add more blood to same test strip.
	Control solution test result.
	Bluetooth® symbol: means the Bluetooth wireless setting is On; the meter can communicate with a mobile device.
	Low batteries.
	Dead batteries.
	Meter error.
	Reminder feature.
	Sound feature.
	7-, 14-, 30-, and 90-day averages.
	Total number of blood glucose readings used to calculate averages.

The Home Screen

The Home screen has 2 options: Logbook and Settings.

• To highlight the Logbook or Settings, press the ▼ button.
• To enter the Logbook, press OK while the Logbook symbol is blinking.
• To enter Settings, press OK while the Settings symbol is blinking.

Your Meter Features

Second-Chance sampling allows you to apply more blood to the same test strip if the first blood sample is not enough. Your test strip is designed to easily 'sip' the blood into the sample tip. Do not drop blood directly on the flat surface of the test strip.

Get Ready to Test

Read your Contour Next GEN user guide, the lancing device package insert, if provided, and all instructional materials provided in your meter kit before testing.

Fingertip Testing

Ensure that you have the materials you need before you begin testing:

• Contour Next GEN meter.
• Contour Next blood glucose test strips.
• Lancing device and lancets from your kit, if provided.

High / Low Blood Glucose

Symptoms of High or Low Blood Glucose

You can better understand your test results by being aware of the symptoms of high or low blood glucose. According to the American Diabetes Association (www.diabetes.org), some of the most common symptoms are:

Low blood glucose (Hypoglycemia):

High blood glucose (Hyperglycemia):

Ketones (Ketoacidosis):

Insert the Test Strip

NOTE: If test strips are stored in a bottle, tightly close the bottle lid immediately after removing a 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.

The screen displays the blinking blood drop indicating it is ready to test a blood drop.

NOTE: After you insert the test strip, apply blood to the test strip within 3 minutes or the meter turns off. Remove the test strip and reinsert it to begin a test.

Get the Blood Drop: Fingertip Testing

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.

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

Second-Chance sampling — Apply More Blood

1. If the meter beeps twice and the screen displays a blinking blood drop with a plus sign, the test strip does not have enough blood.
2. Apply more blood to the same test strip within 60 seconds.

NOTE: If the screen displays an E 1 error message, remove the strip and start with a new strip.

About Meal Markers

You can attach a Meal Marker to your blood glucose result when the Meal Marker feature is turned On. Your Contour Next GEN meter comes with Meal Markers turned Off.

Symbol	What It Means	Target Range
Fasting	Use when testing after fasting (no food or drink for 8 hours, except water or non-caloric beverages).	The meter compares your result against the Before Meal Target Range. (Pre-set to 70 mg/dL–130 mg/dL)
Before Meal	Use when testing within 1 hour before a meal.	The meter compares your result against the Before Meal Target Range. (Pre-set to 70 mg/dL–130 mg/dL)
After Meal	Use when testing within 2 hours after the first bite of a meal.	The meter compares your result against the After Meal Target Range. (Pre-set to 70 mg/dL–180 mg/dL)
No Mark	Use when testing at times other than after fasting or before or after a meal.	The meter compares your result against the Overall Target Range. (Pre-set to 70 mg/dL–180 mg/dL)

smartLIGHT target range indicator

When your blood glucose test is complete, the meter displays your result with the units, time, date, meal marker (if selected), and target range symbol.

If the smartLIGHT setting is On, the test strip port displays a color representing your result value compared to your Before Meal, After Meal, or Overall Target Range.

Yellow means Above Target

Green means In Target

Red means Below Target

Test Results

LO or HI Results

LO

If your meter does not display a value and displays the LO screen, your blood glucose reading is under 20 mg/dL. Contact your health care professional immediately.

HI

If your meter does not display a value and displays the HI screen, 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 the HI screen, follow medical advice immediately.

Eject and Dispose of the Used Lancet

1. Do not use your fingers to remove the lancet from the lancing device.
2. Refer to the separate lancing device insert, if provided with your kit, for instructions on automatic ejection of the lancet.

The Logbook contains blood glucose test results and their Meal Markers. When the Logbook reaches the maximum 800 results, the oldest test result is removed as a new test is completed and saved to the Logbook.

Review the Logbook

NOTE: To return to the Home screen while viewing the Logbook, press OK.

1. Press and hold OK until the meter turns on, about 3 seconds. The Logbook symbol is blinking on the Home screen.
2. To select the blinking Logbook symbol, press OK.
3. To view your individual test results in the Logbook, press the ▼ button.
4. To scroll through your test results, press the ▲ or ▼ button. To scroll faster, press and hold the ▲ or ▼ button.
5. To go back to the beginning to review entries, press OK to go to the Home screen, then select the Logbook symbol.

View Averages

1. To enter the Logbook from the Home screen, press OK while the Logbook is blinking.
2. To view your Averages, press the ▲ button from the first Logbook screen.
3. To scroll through your 7-, 14-, 30-, and 90-day Averages, press the ▲ button.
4. To return to your Logbook readings, press the ▼ button on the 7 d Avg (7-day Average).
5. To exit Averages and return to the Home screen at any time, press OK.

In Settings you can personalize:

NOTE: Press OK to accept the current or changed setting before moving to the next setting.

Access Settings

1. Press and hold OK until the meter turns on.
2. To highlight the Settings symbol, press the ▼ button.
3. When the Settings symbol is blinking, press OK to enter Settings.
4. To scroll through Settings options, press the ▲ or ▼ button until the symbol you want is blinking.
5. Press OK.
6. To exit from the Settings menu and return to the Home screen, press the ▲ or ▼ button until the Settings symbol is blinking.
7. Press OK.

Change the Time

1. From the Home screen, select the Settings symbol and press OK to enter Settings.
2. When the current time is blinking on the Settings screen, press OK. The time format (12 hour or 24 hour) is blinking.
3. To change the time format, if needed, press the ▲ or ▼ button, then press OK.
4. To change the hour (blinking), press the ▲ or ▼ button, then press OK.
5. To change minutes (blinking), press the ▲ or ▼ button, then press OK.
6. For a 12-hour time format, select AM or PM, as needed, then press OK.

Change the Date

1. From the Home screen, select the Settings symbol and press OK to enter Settings.
2. When you are on the Settings screen, press the ▼ button until the current date is blinking, then press OK. The date format (m/d or d.m) is blinking.
3. To select Month/Day/Year (m/d) or Day.Month.Year (d.m), press the ▲ or ▼ button, then press OK.
4. To change the year (blinking), press the ▲ or ▼ button, then press OK.
5. To change the month (blinking), press the ▲ or ▼ button, then press OK.
6. To change the day (blinking), press the ▲ or ▼ button.

Set the Sound

1. From the Home screen, select the Settings symbol and press OK to enter Settings.
2. When you are on the Settings screen, press the ▼ button repeatedly until the Sound symbol is blinking, then press OK.
3. To turn the Sound On or Off, press the ▲ or ▼ button.
4. Press OK.

Your meter comes with the Sound turned On. Certain error messages override any Sound setting.

NOTE: Some sounds remain On even when you turn the Sound feature Off. To turn sounds Off for a below-target blood glucose reading, turn the smartLIGHT feature to Off.

Set Meal Marker Feature

1. From the Home screen, select the Settings symbol and press OK.
2. Press the ▼ button repeatedly until the Meal Marker symbols are blinking, then press OK.
3. To turn Meal Markers On or Off, press the ▲ or ▼ button.
4. Press OK.

Set Reminder Feature

When Meal Markers are On, you can set a Reminder to test your blood glucose after you mark a reading as Before Meal.

1. From the Home screen, select the Settings symbol and press OK.
2. Press the ▼ button repeatedly until the Reminder symbol is blinking, then press OK.
3. To turn the Reminder feature On or Off, press the ▲ or ▼ button.
4. Press OK.

Change Overall Target Range

1. From the Home screen, select the Settings symbol and press OK.
2. Press the ▼ button repeatedly until the Target symbol is blinking, then press OK.
3. To change the blinking Low end of the Overall Target Range, press the ▲ or ▼ button.
4. Press OK.
5. To change the blinking High end of the Overall Target Range, press the ▲ or ▼ button.
6. Press OK.

Set smartLIGHT target range indicator

1. From the Home screen, select the Settings symbol and press OK.
2. Press the ▼ button repeatedly until the smartLIGHT symbol is blinking, then press OK.
3. To turn the smartLIGHT feature On or Off, press the ▲ or ▼ button to display the option you want.
4. Press OK.

Set Bluetooth Wireless Functionality

1. From the Home screen, select the Settings symbol and press OK.
2. Press the ▼ button repeatedly until the Bluetooth symbol is blinking, then press OK.
3. To turn Bluetooth wireless functionality On or Off, press the ▲ or ▼ button.
4. Press OK.

Contour Diabetes app

Your Contour Next GEN meter is designed to work with the Contour Diabetes app and your compatible smartphone or tablet. Visit compatibility.contourone.com for a list of compatible operating systems.

You can do the following with your Contour Diabetes app:

• Add Notes after testing that help to explain your results.
• Set testing reminders.
• Access easy-to-read graphs of test results over a day or over a period of time.
• Share reports.
• Change meter settings, as necessary.

Pairing Mode

To pair your meter with the Contour Diabetes app, download the app and follow the instructions to Pair a Meter.

1. If your meter is off, press and HOLD OK until the meter turns on. The meter displays the Home screen.
2. Press and HOLD the ▲ button for about 3 seconds, until you see the blinking Bluetooth symbol. A blue light blinks when you are in pairing mode.
3. When the meter displays the serial number, follow the instructions on the app to match the meter serial number.
4. When a connection is made, the meter displays the 6-digit pass code. Enter the pass code on the smart device.

NOTE: You can update your Target Ranges from the meter or from the app. The most recently changed Target Ranges will update in the meter and the app when they are synced.

Meter Care

• Store the meter in the carrying case provided, whenever possible.
• Wash and dry hands well before handling to keep the meter and test strips free of water, oils, and other contaminants.
• Handle the meter carefully to avoid damaging the electronics or causing other malfunctions.
• Avoid exposing your meter and test strips to excessive humidity, heat, cold, dust, or dirt.
• Clean and disinfect your meter as recommended in the next section.

Cleaning and Disinfection

Clean and disinfect your Contour Next GEN meter once a week. Use only Clorox Healthcare Bleach Germicidal Wipes (EPA #67619-12) containing 0.55% sodium hypochlorite (bleach).

Cleaning Your Meter

Clean and disinfect your meter once a week.

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

Disinfecting Your Meter

1. Before disinfecting, clean the meter as described in Cleaning Your Meter.
2. Using a new germicidal wipe, carefully wipe all outer surfaces of your meter until wet.

NOTE: For proper disinfection, you must keep all meter surfaces wet for 60 seconds.

3. After keeping the meter wet for 60 seconds, use a clean paper towel to dry the meter surfaces and the test strip port.

Transfer Results to a Personal Computer

You can transfer test results from the Contour Next GEN meter to a computer where they can be summarized in a report with graphs and tables. To make use of this feature, you need diabetes management software and a 1-meter (or 3-foot) long USB-A to Micro USB-B cable.

Batteries

Replace the Batteries

1. Turn off your meter.
2. Turn the meter over and slide the battery cover in the direction of the arrow.
3. Remove both of the old batteries and replace them with two 3-volt CR2032 or DL2032 coin cell batteries.
4. Make sure the '+' sign is facing up on the new batteries.
5. Press each battery into a compartment.
6. Slide the battery cover back into place.
7. Discard old batteries according to your local environmental regulations.

NOTE: Always check the date and time after you replace the batteries.

Control Solution

You should perform a control test when:

• Using your meter for the first time.
• You open a new bottle or package of test strips.
• You think your meter may not be working properly.
• You have repeated, unexpected blood glucose results.

Control Solution Testing

1. Remove a Contour Next blood glucose test strip from the bottle or foil packet.
2. Insert the grey square end of the test strip into the test strip port until the meter beeps.
3. Shake the control solution bottle well, about 15 times before every use.
4. Remove the bottle cap and use a tissue to wipe away any solution around the bottle tip before dispensing a drop.
5. Squeeze a small drop of solution onto a clean, nonabsorbent surface.
6. Immediately touch the tip of the test strip to the drop of control solution.
7. Hold the tip in the drop until the meter beeps. The meter counts down for 5 seconds before the meter displays the control test result. The meter automatically marks the result as a control test. Control test results are not included in your meter Logbook, in blood glucose averages, or in targets in the Contour Diabetes app.
8. Compare your control test result with the range printed on the test strip bottle, foil packet, or bottom of the test strip box.
9. Remove the test strip and dispose as medical waste or as advised by your health care professional.

Error Detection Displays

The meter screen displays error codes (E plus a number) for test result errors, strip errors, or system errors. When an error occurs, the meter beeps 2 times and displays an error code. Press OK to turn off the meter.

Specifications

Product Labeling Symbols

Symbol	Explanatory Text	Standard Reference
	Indicates the manufacturer's catalog number so that the medical device can be identified.	ISO 15223-1, Clause 5.1.6
	Indicates the date after which the medical device is not to be used.	ISO 15223-1, Clause 5.1.4
	Indicates the manufacturer's batch code so that the medical device can be identified.	ISO 15223-1, Clause 5.1.5; IEC 61010-2-101, Table 1, Symbol 102
	Indicates a medical device that is intended to be used as an in vitro diagnostic medical device.	ISO 15223-1, Clause 5.5.1
	Indicates the temperature limits to which the medical device can be safely exposed.	ISO 15223-1, Clause 5.3.7
	Indicates a control material that is intended to verify the performance characteristics of another medical device.	ISO 15223-1, Clause 5.5.2
	Indicates the need for the user to consult the instructions for use.	ISO 15223-1, Clause 5.4.3
	Indicates the need for the user to consult the instructions for use for important cautionary information.	ISO 15223-1, Clause 5.4.4; IEC 61010-1, Table 1, Symbol 14
	Indicates a medical device that is for single use or for use on a single patient during a single procedure.	ISO 15223-1, Clause 5.4.2
	Indicates a medical device that has been sterilized using irradiation.	ISO 15223-1, Clause 5.2.4

Principles of the Procedure

The Contour Next GEN blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is drawn into the tip of the test strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) and the mediator. Electrons are generated, producing a current that is proportional to the glucose in the sample. After the reaction time, the glucose concentration in the sample is displayed. No calculation by the user is required.

References

1. US Food and Drug Administration. Use of fingerstick devices on more than one person poses risk for transmitting bloodborne pathogens: initial communication. US Department of Health and Human Services; update 11/29/2010.
2. Centers for Disease Control and Prevention. Infection Prevention during Blood Glucose Monitoring and Insulin Administration. US Department of Health and Human Services; update June 8, 2017.
3. Wickham NWR, et al. Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes. 1986;3(2):100.
4. Atkin SH, et al. Fingerstick glucose determination in shock. Annals of Internal Medicine. 1991;114(12):1020-1024.
5. American Diabetes Association. 2. Classification and diagnosis of diabetes: Standards of medical care in diabetes—2020. Diabetes Care. 2020;43(supplement 1):S14–S31.
6. International Organization for Standardization / Technical Committee 210. Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements. ISO 15223-1:2016.
7. IEC 61010-2-101 Edition 3.0—Safety requirements for electrical equipment for measurement, control and laboratory use—Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment.
8. IEC 61010-1 Edition 3.1—Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements.
9. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical Chemistry. 5th edition. Philadelphia, PA: WB Saunders Co; 2001:444.

CONTACT INFORMATION

Customer Service is available Monday through Sunday, 8:00 am through 12:00 Midnight, Eastern Time. If this is a medical emergency, please contact your health care professional or dial 911. To leave a message for Customer Service, remain on the line. One of our representatives will return your call as soon as possible.

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Ascensia, the Ascensia Diabetes Care logo, Contour, Microlet, the No Coding logo, Second-Chance, the Second-Chance sampling logo, Smartcolor, and Smartlight are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

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All rights reserved.

90010655 Rev. 07/22