OneTouch Ultra Plus Test Strips

VanTouch Ultra Plus test strips use high-quality "Smart Scan" technology, which ensures high accuracy of the analysis result in full compliance with the latest International Accuracy Standard ISO 15197: 2013. The uniqueness of the Smart Scan technology provides scanning of a blood sample 500 times within 5 seconds, during which the test is carried out. This allows you to "weed out" the possible influence of 26 common interferences (various substances in the human blood, such as maltose, vitamin C, paracetamol, etc., in therapeutic concentrations), which can affect the test result.

Features of OneTouch Ultra Plus® Test Strips

• Test principle: electrochemistry.
• Plasma calibration.
• There is no coding at all.
• The enzyme of the test strips – FAD-GDH (glucose dehydrogenase flavin adenine dinucleotide dependent) - is specific to glucose, excludes the influence of oxygen during the test.
• Measuring range: 1.1-33.3 mmol / L.
• Test time: 5 seconds.
• A tiny drop of blood – only 0.4 μL, which means that the puncture depth is minimal. The shallower the depth, the less pain when testing.
• Capillary test strip – itself draws blood into the capillary from the side of the strip; it can be done on the right or left (convenient for left-handers and right-handers).
• The test strip is protected so you can touch the strip anywhere you like.
• The hematocrit level is 20-60%.
• Application temperature: 6 °С – 44 °С, relative humidity 10% – 90%.
• Palladium and gold electrode surfaces ensure reliable conductivity during testing.
• Accuracy*: 99.2%. For glycemic levels less than 5.5 mmol/L – 100%.

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Appointment

OneTouch Ultra® Plus Test Strips when used with the OneTouch Ultra® Plus Blood Glucose Monitoring System (hereinafter referred to as the meter) with the OneTouch Ultra Plus Flex™ Meter.

Designed for the quantitative determination of glucose (sugar) levels in fresh capillary whole blood taken from the fingertip. For information about blood samples, refer to the user guide that came with your meter.

The OneTouch Ultra® Plus Series Blood Glucose Monitoring Systems are designed for self-monitoring and operate outside the human body (designed for in vitro diagnostics).

They can be used at home by people with diabetes mellitus and by healthcare professionals to examine patients in a clinic setting - as a tool to monitor the effectiveness of diabetes control.

The OneTouch Ultra® Plus Series Blood Glucose Monitoring Systems should not be used to diagnose or screen diabetes, or to measure neonatal blood glucose.

For complete information on the purpose of the system, see the meter user manual supplied with your system.

How to use the test strips:

1. Insert the test strip into the meter. It turns on automatically.
2. Use the lancing device and a new sterile lancet to obtain a small, rounded drop of blood (do not use a blood sample if the drop is smeared or spreads).
3. Bring the meter with the side of the capillary to the drop of blood with a test strip.
4. The test strip draws in the sample itself and tests it according to the capillary principle. Thanks to the Smart Scan technology, the results will be more accurate.
5. Dispose of test strips after use in accordance with legal requirements for disposal.
6. Each test strip can only be used once. Do not return the used test strip back into the vial to avoid errors.

Test results

The OneTouch Ultra® Plus Series of blood glucose meters show results from 1.1 to 33.3 mmol/l.

Read these notes if your test results are higher or lower than you expected.

WARNINGS

Low glucose results

If your blood glucose result is less than 3.9 mmol/l or a low glucose warning appears (that is, your result is less than 1.1 mmol/l), this may mean that you have hypoglycemia (low blood glucose). You may need to take immediate action to correct low blood glucose levels. In any case, follow the advice of your healthcare professional. While this result may be due to a test error, it is safer to take treatment first and then test again.

Dehydration and low glucose results

You can get false low glucose results if you have severe fluid loss (dehydration). If you think this is exactly the case, contact your healthcare professional right away.

High glucose

If the test result exceeds 10.0 mmol/l, it may indicate high blood glucose levels (hyperglycemia). You need to do a second test. See your healthcare professional if you are concerned about high blood glucose levels.

A high glucose alert is displayed when your blood glucose is higher than 33.3 mmol/l. You may have very high blood glucose levels (severe hyperglycemia). Retest your blood glucose. If, as a result, you receive a high glucose warning again, it indicates a serious problem with blood glucose control. You will need to see a healthcare professional immediately and follow their recommendations.

Repeated unexpected blood glucose results

If you get unexpected results repeatedly:

• Perform a control solution test to check the system.
• Make sure you follow all instructions in your User Guide.
• If your symptoms do not match your blood glucose results, see your healthcare professional.

Never ignore symptoms or make significant changes to your diabetes control program without consulting a healthcare professional.

Limitations of the procedure

For accurate results, use OneTouch Ultra® Plus Test Strips under the following conditions:

• The OneTouch Ultra® Plus Series of meters are designed for single patient use and should not be shared with others.
• The OneTouch Ultra® Plus Series Blood Glucose Meters should not be used for the diagnosis or screening of diabetes mellitus, or for the determination of neonatal blood glucose levels.
• The OneTouch Ultra® Plus Series of blood glucose meters should not be used in critically ill patients, patients in shock, patients who are severely dehydrated, or patients who are hyperosmolar (with or without ketosis).
• Do not use serum or blood plasma.
• Hematocrit is the amount of red blood cells in the blood. Too high or low hematocrit values ​​can affect the test results. Hematocrit levels below 20% can cause erroneous high readings. Hematocrit levels above 60% can cause erroneous low readings. See your healthcare professional if you are unsure of your hematocrit level.
• The OneTouch Ultra® Plus Series Meter Series is not recommended for testing blood samples from alternative sites (ASTs).
• The OneTouch Ultra® Plus Test Strips should not be used above 3048 m above sea level, as this may adversely affect test results.
• Other substances that can interfere with the determination of glucose levels. Uric acid and other reducing substances (if present in the blood at a high normal or maximum therapeutic concentration) do not significantly affect the test results. However, a pathologically high concentration of these substances in the blood can lead to underestimated results.

ATTENTION

• The OneTouch Ultra® Plus Series Meter should not be used on patients who have had a D-Xylose uptake test within the previous 24 hours, as this may cause overestimated results.
• Do not use the OneTouch Ultra® Plus Series meters if it is known or suspected that PAM (Pralidoxime) will be available in the patient's whole blood sample.

Bottle, 50 test strips.

• Store the test strip vial in a cool, dry place between 5°C and 30°C and up to 65% relative humidity. Do not store the bottle in the refrigerator. Protect from direct sunlight and heat. The effects of temperature and/or humidity outside the recommended storage limits may cause inaccurate test results.
• The test strip test should be performed at a temperature between 6°C and 44°C and a relative humidity between 10% and 90%.
• The expiry date is printed on the bottle.
• The date the vial contents are disposed of is the date the test strip vial is opened plus 6 months. Record the disposal date on the label after opening a new vial.
• Do not use test strips beyond their expiration date or disposal date, whichever comes first.
• Store test strips only in their original vial. To avoid damage or contamination, do not transfer test strips to any other packaging.
• Only open the vial when you want to take a test strip for later use.
• After removing the test strip from the vial, immediately close it tightly with the cap. Remove the test strip from the vial just before use.
• Do not use test strips if the vial is damaged or left open.
• Avoid contact of the test strips with dirt, food, or liquids. With clean, dry hands, you can touch anywhere on the surface of the test strip.
• Do not bend, cut, or deform test strips.
• Test strips are for single use only.
• Never reuse a test strip that has already had blood or control solution applied.
• Make sure the meter and test strips are at approximately the same temperature before testing.
• Only OneTouch Ultra™ Plus control solution or blood sample can be applied to the test strip.
• Do not put the used test strip back in the vial after testing.
• Used test strips may be considered biohazardous waste in your area. When disposing of them, the advice of a healthcare professional and local legal requirements must be followed.

ATTENTION!

• Store the test strip vial out of the reach of children. Test strips are dangerous due to the risk of choking.
• Do not swallow test strips. The test strip vial may contain a desiccant that is harmful if inhaled or swallowed and may irritate the skin or eyes. Avoid swallowing and getting the contents of the vial into the digestive system or respiratory tract.

LifeScan Scotland Limited, UK.

Service support

Our goal is to provide you with quality medical products. If you have any questions about OneTouch® products, please contact the LifeScan Advisory Line at 0 800 500 353 (free within Ukraine).

Certificate of conformity

No. UA.MD.354-21 dated 04/27/2021

Medical device advertising. Before use, it is imperative to consult a doctor and read the instructions for use of the medical device. Keep out of the reach of children.

ACCURACY - in the test strip!

* 99.2% of OneTouch Ultra Plus Flex ™ measurements are within tolerances (for glycemic levels less than 5.5 mmol/l - 100%) of ISO 15197: 2013.

OneTouch Ultra Plus Flex ™ Study Results: Analytical and Clinical System Accuracy, Hematocrit Effect, Reproducibility, Interference Effect. Evaluations were carried out in accordance with the principles of the International Organization for Standardization ISO, clinical protocols approved by the Ethics Commission.

¹ Clinical guidelines, section 6.2.5. http://vnmed3.kharkiv.ua/wpcontent/uploads/2014/09/Diabet_esc_2014.pdf,

1. Which meter will these test strips go to? Can they be used with different blood glucose meters?

The OneTouch Ultra® Plus Test Strip is suitable for use with the OneTouch Ultra® Plus Series meters, specifically the OneTouch Ultra® Plus Flex Glucometer. The strips are not compatible with other blood glucose meters.

2. What is the shelf life of the test strips?

The expiration date is written on the packaging. It is also worth considering the disposal date after opening the bottle. The test strips have a shelf life of 6 months after opening the vial. Be sure to record the disposal date on the vial. Do not use test strips after the expiration date printed on the vial by the manufacturer, or after 6 months after the date of opening, whichever comes first.

3. Is the test strip recyclable?

No, OneTouch Ultra® Plus test strips are disposable. Do not put them in the bottle after use.

4. Can I use any blood for the test?

Only capillary fresh fingerstick blood may be used to test blood glucose with the meter and OneTouch Ultra® Plus Test Strips.

5. Do I need to carry out additional manipulations during the test?

No, just make a puncture with a lancet. The OneTouch Ultra® Plus Test Strip is capillary and draws blood by itself.