Contour Next GEN 9658 User manual

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USER GUIDE
Uses only Contour®next
blood glucose test strips.
Works with the Contour®Diabetes app available for
download from the App Store®or on Google PlayTM.
Blood Glucose
Monitoring System

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Contour®next GEN blood glucose monitoring system
Customer Service Checklist
When speaking with the Customer Service representative:
B
A
1. Have your Contour®next GEN
blood glucose meter,
Contour®next test strips, and
Contour®next control solution
available when you call.
2. Locate the model number (A) and
serial number (B) on the back of
the meter.
3. Locate the test strips’ expiration
date on the bottle.
4. Check the battery status.
Meter Kit Contents
The table below lists all parts included in this meter kit. Required parts
that may not be included in your kit are indicated by an asterisk (*).
Locate the model number (A) on the back of the meter (see above).
To order parts required for use but not included in your kit, contact
Customer Service at 1-800-348-8100, Monday through Sunday,
8:00 am through 12:00 Midnight, Eastern Time.
Model number
9658 7917 7383
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 test strips* • •
Contour Next control solution* •
MiCrolet®Next lancing device • • •
MiCrolet®lancets • • •
Carrying case • • •
Web registration / warranty card • • •
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 ngertips. 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 eectiveness 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 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 ngertips.
The system is intended for in vitro diagnostic use only.

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Contour®next GEN blood glucose monitoring system
• All parts of the kit are considered biohazardous and can
potentially transmit infectious diseases, even after you have
performed cleaning and disinfection.
• For complete instructions on cleaning and disinfecting your meter
and lancing device, see Cleaning and Disinfection on page 48.
• For more information about cleaning and disinfecting your meter
or lancing device see: “US Food and Drug Administration. Use
of ngerstick 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.”
http://wayback.archive-it.org/7993/20170111013014/http://www.
fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
“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.”
http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
• 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 suocation if accidentally swallowed.
WARNING
Alternative Site Testing (AST) is not intended for use with
this meter.
If your blood sugar reading is under the critical level you have
established with your health care professional, follow their
advice immediately.
If your blood sugar reading is over the recommended limit set
by your health care professional:
1. Wash and dry your hands well.
2. Retest with a new strip.
If you get a similar result, follow your health care professional’s
advice immediately.
Talk to Your Health Care Professional:
• Before setting any Target Ranges in your meter or in compatible
Ascensia Diabetes Care software.
• Before changing your treatment or medication based on test results.
• If you obtain test results that are not consistent with the way you feel.
• Before making any other decision of medical relevance.
Potential Biohazard
• Always wash your hands with antibacterial soap and water and
dry them well before and after testing or handling the meter,
lancing device, or test strips.
• 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 person.
IMPORTANT SAFETY INFORMATION

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Contour®next GEN blood glucose monitoring system
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 ow. 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 (6301 meters).
• Hematocrit: Contour next test strip results are not signicantly
aected 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.
• 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 oces, 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 Immunodeciency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens. 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 bottle is open inside a new box of strips, do not use
those strips.
For replacement parts, contact Customer Service. See the
back cover for contact information.
• Your Contour next GEN meter works ONLY with
Contour next test strips and Contour next control solution.
• Always keep the Contour next test strips in their original bottle.
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. Exposure to room humidity by leaving the bottle
open or not storing the strips in their original bottle can damage
your test strips. This could lead to inaccurate results. Do not use
a test strip that appears damaged or has been used.

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Contour®next GEN blood glucose monitoring system
• Do not use expired materials. Using expired material can cause
inaccurate results. Always check the expiration dates on your test
materials.
NOTE: If this is the rst 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 rst opened the bottle.
• If your control solution test result is out of range, contact Customer
Service. See the back cover for contact information. 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. Whenever the meter is moved from one
location to another, allow approximately 20 minutes for the meter
to adjust to the temperature of the new location before performing
a blood glucose test.
• Do not attempt to perform a blood glucose test when the
Contour next GEN meter is connected to a computer.
• Use only approved equipment (e.g., USB cable) from the
manufacturer or certied 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 will never have a decimal point.
Results in mmol/L will always have a decimal point.
Example:
93
or
52
Check your display screen to be sure the results are shown
correctly (mg/dL). If not, contact Customer Service. See the
back cover for contact information.
• 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.
Your Meter Features
Easy: The Contour next GEN blood glucose monitoring system is
about simplicity. You will notice this the rst time you use it.
Automatic: The Contour next GEN meter is designed with
No Coding technology, to automatically code itself every time you insert
a test strip. It will also automatically mark a control solution test.
Second-Chance®sampling allows you to apply more blood to the
same test strip if the rst 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 at surface of the test strip.
Thank you for choosing the Contour next GEN blood glucose
monitoring system. We are proud to be your partner in helping you
manage your diabetes.
CAUTION: Your Contour next GEN meter works ONLY with
Contour next test strips and Contour next control solution.