Ascensia Diabetes Care Contour next GEN User manual

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93
Uses only CONTOUR®NEXT
blood glucose test strips.
USER GUIDE
Works with free CONTOUR®DIABETES app.
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available at www.diabetes.ascensia.com/warranty
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Blood Glucose Monitoring System

CONTACT INFORMATION
Customer Service is available Monday through Sunday, 8:00 am
through 12:00 Midnight, Eastern Time. If this is a medical emergency,
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Distributed by:
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www.diabetes.ascensia.com
Customer Service: 1-800-348-8100
For information on patents and related licenses,
see www.patents.ascensia.comƔ
Purchase of this product does not alone confer a license to use under
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CONTOUR NEXT GEN meters and CONTOUR NEXT blood glucose test
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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
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The Bluetooth®word mark and logos are registered trademarks
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Table of Contents
1 GETTING STARTED
Your meter display
Meter symbols and the Home screen
2 TESTING
Symptoms of High / Low blood glucose
Fingertip testing
Add a Meal Marker to a blood glucose result
The smartLIGHT target range indicator
Understand test results
3 LOGBOOK
View test results and blood glucose averages
4 SETTINGS
Change the Time and Date
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ËÈÄÄƭŮ»Ã¿Äº»È»·ÊËÈ»
Change Target Ranges
ËÈÄŮÉ÷ÈÊʷȽ»ÊȷĽ»¿Äº¿¹·ÊÅÈ
ËÈÄÄƭŮÂË»ÊÅÅʾ»·ÊËÈ»
Download the CONTOUR DIABETES app
Put your meter in pairing mode
5 HELP
Clean and disinfect your meter
Replace meter batteries
Test with control solution
6 TECHNICAL INFORMATION
Error messages
Order meter kit supplies
Accuracy and Precision
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INTENDED USE
The CONTOUR NEXT GEN blood glucose monitoring system
is intended to be used for the quantitative measurement of
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The CONTOUR NEXT GEN blood glucose monitoring system
is intended to be used by a single person and should not be
ɾ·È»ºƔ¾»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
ÃÅÄ¿ÊÅȿĽʾ»»Ů»¹Ê¿Ì»Ä»ÉÉż·º¿·¸»Ê»É¹ÅÄÊÈÅÂÆÈŽȷÃƔ
The CONTOUR NEXT GEN blood glucose monitoring system
should not be used for the diagnosis of or screening for
º¿·¸»Ê»ÉÅÈ¼ÅÈÄ»ÅÄ·Ê·ÂËÉ»Ɣ¾»CONTOUR NEXT blood glucose
test strips are for use with the CONTOUR®NEXT GEN blood
glucose meter to quantitatively measure glucose in fresh
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The system is intended for in vitro diagnostic use only.
NOTE: This document uses the term ‘blood glucose’ to mean
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WARNING
The CONTOUR NEXT GEN blood glucose meter is not intended
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1

IMPORTANT SAFETY INFORMATION
WARNING
If your blood glucose reading is under the critical
level you have established with your health care
professionalƑ¼ÅÂÂÅÍʾ»¿È·ºÌ¿¹»¿Ãûº¿·Ê»ÂÏƔ
If your blood glucose reading is over the recommended
limit set by your health care professional:
1. ·É¾·ÄººÈÏÏÅËÈ¾·ÄºÉÍ»ÂÂƔ
2. »Ê»ÉÊͿʾ·Ä»ÍÉÊÈ¿ÆƔ
If you get a similar result, follow your health care
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Talk to Your Health Care Professional:
• Before setting any Target Ranges in your meter or in
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• Before changing your treatment or medication based on
Ê»ÉÊÈ»ÉËÂÊÉƔ
• If you obtain test results that are not consistent with the
Í·ÏÏÅË¼»»ÂƔ
•»¼ÅÈ»÷Á¿Ä½·ÄÏÅʾ»Èº»¹¿É¿ÅÄżûº¿¹·ÂȻ»̷Ĺ»Ɣ
2

Potential Biohazard
• Always wash your hands with antibacterial soap and water
and dry them well before and after testing or handling the
ûʻÈƑ·Ĺ¿Ä½º»Ì¿¹»ƑÅÈÊ»ÉÊÉÊÈ¿ÆÉƔ
• If your meter is being operated by a second person who is
providing testing assistance to you, the meter and lancing
device should be disinfected prior to use by the second
Æ»ÈÉÅÄƔ
• All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases, even after you
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For complete instructions on cleaning and disinfecting
your meter, see Section 5 Help: Cleaning and
DisinfectionƔ
For more information about cleaning and disinfecting
your meter or lancing device see: “US Food and Drug
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than one person poses risk for transmitting bloodborne
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Prevention during Blood Glucose Monitoring and Insulin
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»ÈÌ¿¹»ÉƒËƺ·Ê»ËÄ»ʿƑʹʷʸʾƔƢ
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3

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Do not share them with anyone including other family
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• The lancing device usually provided with your kit should
not be used for assisted blood draws by health care
ÆÈż»ÉÉ¿ÅÄ·ÂÉÅÈ·Ê¾»·Âʾ¹·È»ÆÈÅÌ¿É¿ÅÄÉ¿Ê»ÉƔ
• Always dispose of used test strips and lancets as medical
Í·ÉÊ»ÅÈ·É·ºÌ¿É»º¸ÏÏÅËÈ¾»·Âʾ¹·È»ÆÈż»ÉÉ¿ÅÄ·ÂƔ
• All products that come in contact with human blood
should be handled as if capable of transmitting infectious
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•»»ÆÅËÊżÈ»·¹¾ż¹¾¿ÂºÈ»ÄƔ¾¿ÉÁ¿Ê¹ÅÄÊ·¿ÄÉÉ÷ÂÂÆ·ÈÊÉ
ʾ·Ê¹Å˺¹·ËÉ»ÉËŮŹ·Ê¿ÅÄ¿¼·¹¹¿º»ÄÊ·ÂÂÏÉÍ·ÂÂÅÍ»ºƔ
•»»Æ¸·Êʻȿ»É·Í·Ï¼ÈÅÃ¹¾¿ÂºÈ»ÄƔ·ÄÏÊÏÆ»Éż
¸·Êʻȿ»É·È»ÆÅ¿ÉÅÄÅËÉƔ¼ÉÍ·ÂÂÅÍ»ºƑ¿Ãûº¿·Ê»ÂÏ
¹ÅÄÊ·¹ÊÏÅËÈÆÅ¿ÉÅÄ¹ÅÄÊÈÅÂ¹»ÄÊ»ÈƔ
• This device is not intended for use in healthcare or
assisted-use settings such as hospitals, physician
Åů¹»ÉƑÅÈÂÅĽƖÊ»ÈÃ¹·È»¼·¹¿Â¿Ê¿»É¸»¹·ËÉ»¿Ê¾·ÉÄÅÊ
been cleared by FDA for use in these settings, including
for routine assisted testing or as part of glycemic control
ÆÈŹ»ºËÈ»ÉƔ
•Use of this device on multiple patients may lead to
ÊÈ·ÄÉÿÉÉ¿ÅÄżË÷ÄÃÃËÄź»Ű¹¿»Ä¹Ï¿ÈËÉ
(HIV), Hepatitis C Virus (HCV), Hepatitis B Virus
(HBV), or other bloodborne pathogens.
4

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
Limitations
•Serious Illness: The system should not be used to test
critically ill patients and should not be used by persons
ͿʾÈ»ºË¹»ºƻȿƾ»È·Â¸ÂÅźŲÅÍƔÄ·¹¹ËÈ·Ê»È»ÉËÂÊÉ÷Ï
occur in severely hypotensive individuals, those dehydrated
ÅÈÆ·Ê¿»ÄÊÉ¿ÄɾŹÁƔÄ·¹¹ËÈ·Ê»ÂÅÍÈ»ÉËÂÊÉ÷ÏŹ¹ËÈ¼ÅÈ
individuals experiencing a hypoxia state, or a hyperglycemic-
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•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:ʼˀƯˀʼ
•Test Strip Storage Conditions: 41°F–86°F, 10%–80%
Relative Humidity (RH)
•Second-Chance®sampling conditions: Temperature
·Ä½»ʼˀƯˀʼƑ»Ã·ÊŹȿÊʹʷƯʼʼ
•Sample Volume:ʷƔʽǹ
•Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood
•Altitude: This system has not been tested at altitudes higher
ʾ·ÄʹʷƑʽʾʻ¼»»ÊƺʽƑʺʷʸûʻÈÉƻƔ
•Hematocrit: CONTOUR NEXT blood glucose test strip results are
ÄÅÊÉ¿½Ä¿Ű¹·ÄÊÂÏ·Ů»¹Ê»º¸Ï¾»Ã·ÊŹȿÊ»̻ÂÉ¿Äʾ»ȷĽ»żʹʷ
ÊÅʼʼƔ
•Xylose: Do not use during or soon after xylose absorption
Ê»ÉʿĽƔÏÂÅÉ»¿Äʾ»¸ÂÅźÍ¿ÂÂ¹·ËÉ»·Ä¿Äʻȼ»È»Ä¹»Ɣ
•Neonatal Use: The CONTOUR NEXT GEN meter is not
indicated¼ÅÈÄ»ÅÄ·Ê·ÂËÉ»Ɣ
5

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• Examine the product for missing, damaged, or broken
Æ·ÈÊÉƔ¼ʾ»Ê»ÉÊÉÊÈ¿ÆÆ·¹Á·½¿Ä½¿ÉÅÆ»ÄÅÈº·Ã·½»ºƑºÅ
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Contact InformationƔ
• Your CONTOUR NEXT GEN meter works ONLY
with CONTOUR NEXT blood glucose test strips and
CONTOUR®NEXT¹ÅÄÊÈÅÂÉÅÂËÊ¿ÅÄƔ
• Always keep the CONTOUR NEXT blood glucose test strips
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¸ÅÊÊ»¿Ãûº¿·Ê»ÂÏ·¼Ê»ÈÈ»ÃÅ̿Ľ·Ê»ÉÊÉÊÈ¿ÆƔ¾»¸ÅÊÊ»¿É
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exposing meter and test strips to excessive humidity, heat,
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the bottle open or not storing the strips in their original
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º·Ê»ÉÅÄÏÅËÈÊ»ÉÊ÷ʻȿ·ÂÉƔ
NOTE: ¼ʾ¿É¿Éʾ»ŰÈÉÊʿûÏÅË·È»ÅƻĿĽʾ»¹ÅÄÊÈÅÂ
ÉÅÂËÊ¿ÅÄƑÍÈ¿Ê»ʾ»º·Ê»ÅÄʾ»¸ÅÊÊ»Ɣ
• Do not use control solution that is more than 6 months past
ʾ»º·Ê»ÏÅËŰÈÉÊÅƻĻºʾ»¸ÅÊÊ»Ɣ
• If your control solution test result is out of range, contact
ËÉÊÅûÈ»ÈÌ¿¹»Ɣ»»Contact InformationƔÅÄÅÊËÉ»ʾ»
ûʻÈ¼ÅÈ¸ÂÅź½Â˹ÅÉ»Ê»ÉʿĽËÄÊ¿ÂÏÅËÈ»ÉÅÂÌ»ʾ¿É¿ÉÉË»Ɣ
• The meter is designed to give accurate blood testing results
·ÊÊ»ÃƻȷÊËÈ»É¸»ÊÍ»»Äʻʸ·ÄºʸʸʺƔ¼ʾ»ûʻÈÅÈÊ»ÉÊ
6

strip is outside this range, you should not test until the meter
·ÄºÊ»ÉÊÉÊÈ¿Æ·È»Ϳʾ¿Äʾ¿ÉȷĽ»Ɣ¾»Ä»Ì»Èʾ»ûʻÈ¿É
moved from one location to another, allow approximately
20 minutes for the meter to adjust to the temperature of the
Ä»ÍÂŹ·Ê¿ÅÄ¸»¼ÅÈ»ƻȼÅÈÿĽ·¸ÂÅź½Â˹ÅÉ»Ê»ÉÊƔ
• Do not attempt to perform a blood glucose test when the
CONTOUR NEXT ûʻÈ¿É¹ÅÄÄ»¹Ê»ºÊÅ·¹ÅÃÆËÊ»ÈƔ
• Use only approved equipment (for example, USB cable)
¼ÈÅÃʾ»÷Ä˼·¹ÊËÈ»ÈÅÈ¹»ÈÊ¿Ű»º¸ÅºÏÉ˹¾·ÉƑƑ
ƑÅÈƔ
• Your CONTOUR NEXT GEN meter has been preset and
locked to display results in mg/dL (milligrams of glucose
Æ»Èº»¹¿Â¿Ê»Èż¸ÂÅźƻƔ
»ÉËÂÊÉ¿ÄýƭººÅÄÅÊ¾·Ì»·º»¹¿Ã·ÂÆÅ¿ÄÊƔ
»ÉËÂÊÉ¿ÄÃÃÅÂƭ¾·Ì»·º»¹¿Ã·ÂÆÅ¿ÄÊƔ
Example:
93
or
52
Check your display screen to be sure the results are
ɾÅÍÄ¹ÅÈÈ»¹ÊÂÏƺýƭºƻƔ¼ÄÅÊƑ¹ÅÄÊ·¹ÊËÉÊÅûÈ
»ÈÌ¿¹»Ɣ»»Contact InformationƔ
• The CONTOUR NEXT GEN blood glucose monitoring
ÉÏÉÊ»Ã¾·É·û·ÉËȿĽȷĽ»żʹʷýƭºÊÅʽʷʷ ýƭºƔ
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 immediatelyƔ
|If your meter does not display a value and displays the
HI screen, wash your hands or the test site and repeat
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the HI screen, follow medical advice immediatelyƔ
7