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OneTouch Verio Handleiding

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• Test results may be falsely low if the patient is severely dehydrated, in shock or in a
hyperosmolar state (with or without ketosis).
• Critically ill patients should not be tested with the OneTouchVerio® Family of Meters.
The following table provides interfering levels for the OneTouchVerio® Family of Meters
Interfering Substance OneTouchVerio® Family of Meters
Tolazamide Concentrations greater than 10.8mg/dL may cause
falsely low results
Uric Acid Concentrations greater than 8mg/dL may cause
falsely low results
CAUTION:
• The OneTouchVerio® Family of Blood Glucose Monitoring Systems should not be used
for patients within 24 hours of receiving a D-xylose absorption test as it may cause
inaccurately high results.
• Do Not use the OneTouchVerio® Family of Blood Glucose Monitoring Systems when
PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample.
• Dehydration and low glucose results
You may get false low glucose results if you are severely dehydrated. If you think this is
the case, contact your healthcare professional right away.
Alternate Site Limitations
OneTouchVerio® Family of Meters are not indicated for Alternate site testing (AST).
Refer to the User Guide or Owner's Booklet that came with your meter for the full system
intended use.
Test Principle
The OneTouchVerio® Family of Meters is plasma-calibrated for easy comparison of results with
lab methods. Glucose in the blood sample mixes with special chemicals on the test strip to
produce an electrical current. The strength of the current changes with the amount of glucose
in the blood sample. The OneTouchVerio® Family of Meters measures the current, calculates
your blood glucose level and shows your result.
Reagent Composition
Each test strip contains: avin adenine dinucleotide dependent glucose dehydrogenase or
FAD-GDH (from Aspergillus sp.) - 2 U; potassium ferricyanide 41 µg; and other ingredients
(buer, etc.). The vial contains a drying agent.
Performance Characteristics
The performance of the OneTouchVerio® Test Strip has been evaluated both in laboratory and
in clinical tests.
Measurement Range: The measurement range of the OneTouchVerio® Family of Meters is
20 to 600 mg/dL.
The following data is representative of the OneTouchVerio® Family of Meters. Refer to your
system Owner’s Booklet for performance data specic to your system.
System Accuracy
Samples from 100 patients were tested using both the OneTouchVerio® System and the YSI
2300 Glucose Analyzer laboratory instrument.
System Accuracy Results for Glucose Concentrations <75 mg/dL
Percent (and number) of meter results that match the laboratory test
Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL
50.7% (35/69) 89.9% (62/69) 100.0% (69/69)
System Accuracy Results for Glucose Concentrations ≥75 mg/dL
Percent (and number) of meter results that match the laboratory test
Within ±5% Within ±10% Within ±15% Within ±20%
62.3% (144/231) 89.2% (206/231) 97.8% (226/231) 100% (231/231)
System Accuracy Results across the entire Glucose Range
Percent (and number) of meter results that match the laboratory test
Within ±15 mg/dL or ±20%
100% (300/300)
Regression Statistics
Samples were tested on each of three test strip lots. Results indicate that the OneTouchVerio®
System compares well with a laboratory method.
# of Subjects # of Tests Slope Intercept (mg/dL)
100 300 0.99 5.14
95% CI Slope 95% CI Intercept
(mg/dL)
Std. Error (S
y.x
)
(mg/dL)
R
2
0.98 to 1.00 3.06 to 7.23 9.72 0.99
Precision
Within Run Precision (300 Venous Blood Tests per glucose level)
Data generated using the OmniPod® Insulin Management System.
Target Glucose
(mg/dL)
Mean Glucose
(mg/dL)
Standard Deviation
(mg/dL)
Coecient of
Variation (%)
40 47.0 1.37 2.92
100 105.8 2.62 2.47
130 136.4 3.62 2.65
200 212.6 5.21 2.45
350 366.8 9.16 2.50
Results show that the greatest variability observed between test strips when tested with
blood is 2.65% or less.
Total Precision (200 Control Solution Tests per glucose level)
Data generated using the OneTouchVerio IQ® Meter.
Glucose Level Ranges
(mg/dL)
Mean Glucose
(mg/dL)
Standard Deviation
(mg/dL)
Coecient of
Variation (%)
Level 2(38-62) 50.31 1.77 3.52
Level 3(102-138) 117.14 2.70 2.31
Level 4(298-403) 342.34 8.68 2.53
IMPORTANT: For instructions, technical data and a list of symbols used, read your system
User Guide or Owner's Booklet.
OUR COMMITMENT TO YOU
Our goal is to provide you with quality healthcare products and dedicated customer service.
If you are not fully satised with this product, or if you have questions about the use of any
LifeScan product, contact Customer Service. As your partner in diabetes care, we welcome you
to contact us (available 7 days a week, 8 a.m. - 8 p.m. Eastern Time) at 1888567-3003 (English),
1888567-3010 (Spanish), or www.OneTouch.com. If you cannot reach Customer Service,
contact your healthcare professional for advice.
For a complete list of all symbols used, refer to the User Guide or Owner's Booklet that came
with your system.
Read instructions.
Test strips made in the UK
OneTouch®
In vitrodiagnostic.For self-testing.
IMPORTANT: Please read this insert and your User Guide or Owner's Booklet before
using. The User Guide or Owner's Booklet has full instructions for blood glucose and
control solution testing. Do Not use new test strips if the vial is open or damaged in
any way. This could lead to error messages or inaccurate blood glucose results. Contact
Customer Service right away if you have questions about your test strips, test results
or these instructions. As your partner in diabetes care, we welcome you to contact
us (available 7 days a week, 8 a.m. - 8 p.m. Eastern Time) at 1888567-3003 (English),
1888567-3010 (Spanish), or www.OneTouch.com.
Refer to your User Guide or Owner's Booklet for important information about cleaning
and disinfecting your meter, lancing device, and caps.
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! All parts of the kit are
considered biohazardous and can potentially transmit infectious diseases, even after you
have performed cleaning and disinfection.
Intended Use
The OneTouchVerio® Test Strips are used with the OneTouchVerio® Family of Blood
Glucose Monitoring Systems (OneTouchVerio®, OneTouch Verio IQ®, OneTouchVerio®Sync,
OneTouch Verio Flex®) for the quantitative measurement of glucose (sugar) in fresh capillary
whole blood samples drawn from the ngertips. The OneTouchVerio® Family of Blood Glucose
Monitoring Systems is intended to be used by a single person and should not be shared.
The OneTouchVerio® Family of Blood Glucose Monitoring Systems is not to be used for the
diagnosis of or screening of diabetes or for neonatal use.
Refer to the User Guide or Owner's Booklet that came with your meter for the full system
intended use.
Storage and Handling
• The expiration date is printed on the vial.
• The discard date is 6 months after you rst open a test strip vial. When you open a new vial,
write the discard date on the label.
• Do Not use after the expiration or discard date, whichever comes rst.
• Store the test strip vial in a cool dry place between 41°F and 86°F and below 65% relative
humidity. Keep away from direct sunlight and heat. Do Not store the test strip vial
in rooms where the air is humid such as the kitchen, laundry room or bathroom.
Exposure to temperatures outside the storage limits, as well as moisture and humidity, may
cause inaccurate readings.
• Store your test strips in the vial only. To avoid damage or contamination, Do Not put test
strips in any other container.
• Open the vial only when taking out a test strip for use.
• Close the vial lid tightly right away after removing a test strip. Use each test strip as soon as
you take it out of the vial.
• Do Not use test strips from a vial that is damaged or left open to air.
• Do Not get dirt, food or liquids on the test strip. You may touch the test strip anywhere on
its surface with clean, dry hands.
• Do Not bend, cut or alter test strips in any way.
• Test strips are for single use only.
• Never reuse a test strip that already has blood or control solution on it.
• Make sure your meter and test strips are about the same temperature before you test.
• Apply only OneTouchVerio® Control Solution or a blood sample to the test strip.
• Do Not put the used test strip back in the vial after taking a test.
• Used test strips may be considered biohazardous waste in your area. Be sure to follow your
healthcare professional’s advice or local laws when throwing them away.
WARNING: Keep the test strip vial away from children. Test strips are a choking
hazard. Do Not swallow test strips. The test strip vial may contain drying agents
that are harmful if inhaled or swallowed and may cause skin or eye irritation. Do
Not ingest or swallow any items.
Testing your blood glucose
Read your system User Guide or Owner's Booklet for instructions on running a blood test and
getting a blood sample.
Test Results
The OneTouchVerio® Family of Meters shows results between 20 and 600 mg/dL.
Read these cautions when your test results are higher or lower than what you expect.
CAUTION:
Low glucose results
If your blood glucose result is below 70mg/dL or a low glucose warning is displayed,
(meaning the result is less than 20mg/dL), it may mean hypoglycemia (low blood
glucose). You may need to treat low glucose right away. Follow your healthcare
professional's advice. The result could be due to a test error, but it is safer to treat rst,
then test again.
High glucose results
If your test result is above 180mg/dL, it may mean high blood glucose (hyperglycemia).
You should think about re-testing. Talk to your healthcare professional if you are
concerned about high blood glucose.
A high glucose warning is shown when your blood glucose level is over 600mg/dL. You
may have very high blood glucose (severe hyperglycemia). Re-test your blood glucose.
If the result is a high glucose warning again, this indicates a severe problem with your
blood glucose control. Obtain and follow instructions from your healthcare professional
right away.
Repeated unexpected glucose results
If you get repeated unexpected results:
• Run a control solution test to check your system.
• Make sure you follow all instructions in your User Guide or Owner's Booklet.
• If your symptoms don't match your blood glucose results, call your healthcare
professional.
Never ignore symptoms or make signicant changes to your diabetes management
program without speaking to your healthcare professional.
Range of Expected Values
Blood glucose management requires the help of a healthcare professional. Talk to your
healthcare professional about:
• The target blood glucose range that is right for you.
• When to test.
• What your blood glucose results mean.
Expected blood glucose levels for non-pregnant people without diabetes
1
:
Time Range, mg/dL
Fasting Less than 100
2 hours after meals Less than 140
1
American Diabetes Association, Standards of Medical Care in Diabetes, Diabetes Care Vol. 38,
Supplement 1, S1-S94, January 2015.
Checking the System
Use only OneTouchVerio® Control Solution
A control solution test is used to check that:
• The meter and test strips are working together properly.
• You are doing the test correctly.
Do a control solution test
• When you open a new vial of test strips.
• If you think the meter or test strips are not working properly.
• If you get repeated unexpected blood glucose results.
• If you drop or damage the meter.
Read your system User Guide or Owner's Booklet for instructions on how to run a control
solution test.
Limitations of Procedure
OneTouchVerio® Test Strips give accurate results under the following conditions:
• Use only fresh capillary whole blood. Do Not use serum or plasma.
• Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit may
aect test results. Hematocrit levels below 20% may cause false high readings. Hematocrit
levels over 60% may cause false low readings. Talk to your healthcare professional if you
don't know your hematocrit level.
• OneTouchVerio® Test Strips may be used at altitudes up to 10,000feet with no eect on test
results.
Test Strips
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