OneTouch Ultra Test Strips

OneTouch Ultra® Test Strips – 2 vials of  № 25 test strips in one box. For self-monitoring of blood glucose with OneTouch Ultra® and OneTouch UltraEasy® glucometers.

Features of OneTouch Ultra® Test Strips

• Test principle: electrochemistry.
• Plasma calibration.
• Dual precision control - two working electrodes per OneTouch Ultra® test strip.
• Measuring range: 1.1-33.3 mmol/L.
• Test time: 5 seconds.
• Blood sample - 1.5 μL.
• Capillary filling - the test strip draws blood by itself.
• All OneTouch Select® test strips are coded 25.
• Protected test strip - can be touched wherever you want.
• High specificity for glucose - the enzyme GLUCOSOOXIDASE, specific for D-glucose and does not react with other sugars that may be present in the blood.
• The hematocrit level is 30-55%. Hematocrit is the percentage of red blood cells in the blood. Deviations in hematocrit from the reference range may affect test results. Blood glucose measurements may be overestimated if hematocrit is less than 30%, and if hematocrit is greater than 55%, measurements may be underestimated. If you are unsure of your hematocrit level, check with your doctor.
• Application temperature: 6°С–44°С, relative humidity 10%–90%.
• OneTouch Ultra® Test Strips can be used up to 10,000 feet (3048 meters) without affecting test results.

Appointment

OneTouch Ultra® Test Strips are designed to quantitatively measure glucose in fresh capillary whole blood.

Used for self-monitoring of blood glucose with the OneTouch Ultra® and OneTouch UltraEasy® meters, which are calibrated to blood plasma, which allows you to compare the results obtained with laboratory results.

For use by people with diabetes at home and by healthcare professionals in a clinical setting. Blood samples taken from the fingertips, palms, and forearms are suitable for OneTouch Ultra® Test Strips and their corresponding blood glucose meters.

How to use test strips for testing

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. Touch the top edge (end) of the test strip to the drop of blood - the capillary draws in the blood sample by itself. In this case, the control field of the test strip changes color from yellow to red. Analysis takes place inside the strip. Thanks to the two working electrodes, the results will be more accurate.
4. Dispose of test strips after use according to local disposal regulations.
5. Each test strip can only be used once. Do not return the used test strip back into the vial to avoid errors.

ATTENTION

It is important to ensure that the code on the meter matches the code on the test strip vial for accurate results. It is necessary to check the correspondence of the codes before each analysis. For instructions on coding your meter, see the manual that came with your meter.

Test results

Low glucose readings

If the test result is lower than 1.1 mmol/д, a low blood glucose warning appears on the display. This may indicate severe hypoglycemia (low blood glucose). It is necessary to immediately take the measures recommended by the attending physician. While this message may be due to an erroneous test result, it is safer to take remedial action first and then test again.

High glucose readings

If the test result is higher than 33.3 mmol/д, a high blood glucose warning appears on the display. This may indicate severe hyperglycemia (high blood glucose). Retest your blood glucose. If the warning appears again, contact your doctor immediately.

In case of unexpected measurement results

If your blood glucose level is less than 3.9 mmol/д, which corresponds to a low blood glucose level, or more than 10.0 mmol/д, which corresponds to a high blood glucose level, you should immediately contact your doctor for treatment recommendations.

If you see unexpected results again, you need to check the meter with control solution.

If your blood glucose results do not match your symptoms and you followed all instructions in the manual, contact your healthcare professional.

Never ignore symptoms or make significant changes to your diabetes management program without consulting your healthcare provider.

Limitations of the procedure

Measurements using OneTouch Ultra® Test Strips will be accurate if the following limitations are met.

The OneTouch Ultra® Series meters are intended for single patient use and should not be shared with others.

• DO NOT use a meter with test strips to diagnose diabetes or to measure blood glucose in newborns.
• Test strips are for single use only. DO NOT use the same test strip twice.
• These test strips are specific for the determination of D-glucose and do not react with other sugars that may be present in the blood.
• Use only fresh capillary whole blood. DO NOT use serum or plasma.
• Hematocrit is the amount of red blood cells in the blood. A deviation of the hematocrit level from the normal range may affect the test results. If the hematocrit is less than 30%, the blood glucose measurements may be abnormally high, and if the hematocrit is more than 55%, the measurements may be abnormally low. If you are unsure of your hematocrit level, consult your healthcare professional.
• OneTouch Ultra® Test Strips can be used up to 3048 m without affecting the accuracy of the test results. The accuracy of the results has been confirmed in clinical trials carried out at an altitude of about 1609 m and in trials that simulated altitudes up to 3048 m.

Doctors treat you, you should pay attention to the additional restrictions of this procedure

• Fresh capillary blood can be collected in heparinized tubes if it is examined within 10 minutes. DO NOT use other anticoagulants or preservatives.
• Other substances that can affect the determination of glucose levels: acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C) and other reducing substances (present in the blood of a healthy person or in normal therapeutic concentrations) practically do not affect the test results. However, abnormally high concentrations of these substances in the blood can cause overestimated results.
• In patients receiving oxygen therapy, results may be erroneously low.
• Test results may be falsely low if the patient is severely dehydrated, in shock, or has increased blood osmolarity (with or without ketosis). Do not use blood glucose meters to measure blood glucose in critically ill patients.
• Blood with a high lipid content: cholesterol levels up to 18.1 mmol/l and triglycerides up to 33.9 mmol/l do not affect the test results. Meter performance was not tested with blood samples from patients with severe lipidemia. It is not recommended to use the OneTouch Ultra® series of blood glucose meters for examining these patients.

1 package – 2 bottles of 25 test strips each.

• Store the test strip vial in a cool dry place at 4°C to 30°C and up to 60% relative humidity. DO NOT store test strips in the refrigerator. Protect from direct sunlight and heat. The effects of temperature and 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%.
• When opening the vial for the first time, record the disposal date (date of opening plus 6 months) on the vial label.
• DO NOT use test strips after the expiration date (printed on the vial label) or the disposal date, whichever comes first.
• Store test strips only in their original vial. To avoid damage or contamination, DO NOT put test strips in any other container.
• DO NOT open the test strip vial until you are ready to test. Only open the vial when you need to take a test strip for future use.
• After removing the test strip from the vial, immediately close the cap tightly. Use the test strip as soon as you receive it from the vial.
• DO NOT use test strips from a vial that has been damaged or has been opened.
• Avoid contact of the test strips with dirt, food, or liquids. You can only touch anywhere on the surface of the test strip with clean, dry hands.
• Do not bend, cut, or deform the test strip.
• 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 control solution or blood sample can be applied to the test strip.
• After testing, DO NOT put the used test strip back in the vial.
• Used test strips may be considered biohazardous waste in your area. Follow your healthcare professional's advice and local regulations for proper disposal of these items.

ATTENTION!

Store the test strip vial out of the reach of children. Swallowing the test strip may present a risk of airway blockage or suffocation. 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. Do not swallow any of the components in the kit.

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).

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

ACCURACY - in the test strip!

* Proven accuracy of results on high and low sugars, confirmed by many years of clinical research. (2008-2014, UK, 118 test strip batches, 75,000 volunteers). 99.99% of the results in zone A and B (clinically accurate values) according to the Parkes bias analysis method. Of the 71437 measurements with the OneTouch® Ultra® System, 70526 (98.7%) met ISO accuracy criteria. This high measurement accuracy has been maintained throughout the years of research.

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 Test Strip is suitable for use with the OneTouch Ultra and OneTouch UltraEasy glucometers. 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 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 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 Test Strip is capillary and draws blood by itself.