OneTouch Select Plus Blood Glucose Monitoring System

Blood glucose monitoring system.

Reagent Composition: Each test strip contains: Glucose oxidase (Aspergillus niger) ≥ 0.08 IU; ferricyanide ≥ 22 μg; other ingredients (buffer, etc.). The vial contains a drying agent.

Test principle: The OneTouch Select Plus Family of Meters are plasma-calibrated for easy comparison of results with lab methods. Glucose in the blood sample mixes with Glucose Oxidase on the test strip to produce an electrical current. The strength of the current changes with the amount of glucose in the blood sample. OneTouch Select Plus Family of Meters measures the current, calculates the blood glucose level and shows the result.
Performance Characteristics: See the system User Guide or Owner's Booklet.
Measurement Range: The measurement range of the OneTouch Select Plus Family of Meters is 1.1 to 33.3 mmol/L (20 to 600 mg/dL).

The OneTouch Select Plus Test Strips are used with the OneTouch Select Plus Family of Blood Glucose Monitoring Systems (OneTouch Select Plus) for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch Select Plus Family of Blood Glucose Monitoring Systems is intended to be used by a single patient and should not be shared.
The OneTouch Select Plus Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and with their healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.
The OneTouch Select Plus 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 the meter for the full system intended use.

Testing the blood glucose: Read the system User Guide or Owner's Booklet for instructions on running a blood test and getting a blood sample.
Test Results: The OneTouch Select Plus Family of Meters shows results between 1.1 and 33.3 mmol/L (20 and 600 mg/dL).
Read these cautions when the test results are higher or lower than expected.
CAUTION: Low glucose results: If the blood glucose result is below 3.9 mmol/L (70 mg/dL) or a low glucose warning is displayed, (meaning the result is less than 1.1 mmol/L (20 mg/dL)), it may mean hypoglycaemia (low blood glucose). The patient may need to treat low glucose right away. Follow the healthcare professional's advice. The result could be due to a test error, but it is safer to treat first, then test again.
Dehydration and low glucose results: The patient may get false low glucose results if he/she is severely dehydrated. If the patient thinks this is the case, contact the healthcare professional right away.
High glucose results: If the test result is above 10.0 mmol/L (180 mg/dL), it may mean high blood glucose (hyperglycaemia). The patient should think about re-testing. The patient should talk to the healthcare professional if he/she is concerned about high blood glucose.
A high glucose warning is shown when the blood glucose level is over 33.3 mmol/L (600 mg/dL). The patient may have very high blood glucose (severe hyperglycaemia). Re-test the blood glucose. If the result is a high glucose warning again, this indicates a severe problem with the blood glucose control. Obtain and follow instructions from the healthcare professional right away.
Repeated unexpected glucose results: If the patient gets repeated unexpected results: Run a control solution test to check the system.
Make sure to follow all instructions in the User Guide or Owner's Booklet.
If the symptoms don't match the blood glucose results, call the healthcare professional.
Never ignore symptoms or make significant changes to the diabetes management programme without speaking to the healthcare professional.
Range of Expected Values: Blood glucose management requires the help of a healthcare professional. Talk to the healthcare professional about: The target blood glucose range that is right; When to test; What the blood glucose results mean. (See table.)

Click on icon to see table/diagram/image

Checking the System: Use only OneTouch Select Plus Control Solution: A control solution test is used to check that: The meter and test strips are working together properly; The patient is doing the test correctly.
Do a control solution test: When the patient opens a new vial of test strips; If the patient thinks the meter or test strips are not working properly; If the patient gets repeated unexpected blood glucose results; If the patient drops or damages the meter.
Read the system User Guide or Owner's Booklet for instructions on how to run a control solution test.
CAUTION: If the patient continues to get control solution results that fall outside the range printed on the test strip vial, Do Not use the meter, test strips, or control solution. Contact Customer Care.
The control solution ranges printed on the test strip vial are for control solution tests only and are not recommended ranges for the blood glucose level.

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.

IMPORTANT: Please read the monograph, insert and the 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. The patient should contact Customer Care right away if he/she has questions about the test strips, test results or these instructions.
Limitations of Procedure: OneTouch Select Plus Test Strips give accurate results under the following conditions: Do Not use for the diagnosis of diabetes or the testing of newborns.
The test strips are specific to D-glucose and do not react to other sugars which may be present in blood.
Use only fresh capillary whole blood. Do Not use serum or plasma.
Haematocrit is the percentage of red blood cells in the blood. Extremes in haematocrit may affect test results. Haematocrit levels below 30% may cause false high readings. Haematocrit levels over 55% may cause false low readings. The patient should talk to the healthcare professional if he/she doesn't know his/her haematocrit level.
OneTouch Select Plus Test Strips may be used at altitudes up to 3048 metres with no effect on test results.
Healthcare professionals - please note these additional limitations of procedure: Interferences: Uric acid and other reducing substances (when occurring in blood at high normal or at high therapeutic concentrations) do not significantly affect results. However, abnormally high concentrations in blood may cause inaccurately high results.
Patients undergoing oxygen therapy may yield falsely low results.
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 blood glucose meters.
CAUTION: Do Not use the OneTouch Select Plus System when PAM (Pralidoxime) is known or suspected to be in the patient's whole blood sample, as it may cause inaccurate results.
Alternate Site Limitations: The OneTouch Select Plus Family of Meters are not indicated for Alternate site testing (AST).

Handling: 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 taken out of the vial, especially in high humidity environments.
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. The patient may touch the test strip anywhere on its surface with clean, dry hands.
Do Not bend, cut or alter test strips in any way.
Do Not test with a test strip that is bent or damaged.
Test strips are for single use only.
Never reuse a test strip that already has blood or control solution on it.
Make sure the meter and test strips are about the same temperature before testing.
Do Not test if there is condensation (water build-up) on the meter. Move the meter and test strips to a cool, dry spot and wait for the meter surface to dry before testing.
Apply only OneTouch Select Plus 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. Be sure to follow the healthcare professional's advice or local laws when throwing them away.

Store the test strip vial in a cool dry place between 5°C and 30°C. Do Not refrigerate. Keep away from direct sunlight and heat. Exposure to temperatures and/or humidity outside the storage limits may cause inaccurate readings.
Store the test strips in the vial only. To avoid damage or contamination, Do Not put test strips in any other container.

Personal Care

V07AD - Blood tests, auxiliary products ; Used as auxiliary products in blood tests.
V04CA02 - glucose ; Belongs to the class of diagnostic agents used to test for diabetes.