OneTouch Select Plus Simple®

The OneTouch Select Plus Simple® blood glucose monitoring system is designed for self-monitoring outside the human body (in vitro diagnostic use). It can be used by people with diabetes at home and with their healthcare professionals in a healthcare setting as an aid to monitoring the effectiveness of diabetes control. The system is intended for use by one patient only and should not be shared with other persons.

The OneTouch Select Plus Simple® Blood Glucose Monitoring System is not intended for the diagnosis or screening of diabetes mellitus or for the measurement of blood glucose in newborns.

The OneTouch Select Plus Simple® Blood Glucose Monitoring System is not intended for use in critically ill, shocked, severely dehydrated, or hyperosmolar patients.

Principle of testing

The glucose in the blood sample is mixed with the test strip enzyme, glucose oxidase, to produce a small electric current. The strength of this current varies depending on the level (concentration) of glucose in the blood sample. Your blood glucose meter measures the current, calculates your blood glucose level, displays this result on the screen, and stores it in memory.

The OneTouch Select Plus Simple® Blood Glucose Monitoring System includes:

• OneTouch Select Plus Simple® Blood Glucose Monitor with CR2032 flat-cell lithium battery included Injection
• pen OneTouch® Delica® Plus
• Lancets OneTouch® Delica® Plus Lancets - 10 sterile lancets
• Instructions for use in Ukrainian.

Sold separately: OneTouch Select® Plus Test Strips, OneTouch® Delica® Plus Lancets. For the Control Solution OneTouch Select® Plus, please contact the Lifescan Consultation Line at: 0 800 500 353 (free of charge in Ukraine), Monday-Friday, 09:00-18:00. 

WARNING! Keep your blood glucose meter and testing supplies out of the reach of children. Small items such as the battery compartment cover, batteries, test strips, lancets, lancet protective caps, and control solution vial caps pose a risk of airway obstruction. Do not swallow any components.

To conduct the test, it is important to:
• Use only OneTouch Select^® Plus test strips. 
• Before testing, make sure that the meter and test strips are at approximately the same temperature.
• Do not test if there is condensation (water droplets) on the meter. Move your meter and test strips to a cool, dry place and wait until the surface of the meter is dry before testing.
• Store test strips in a dry place at a temperature between 5°C and 30°C.
• Do not open the test strip vial until you are ready to remove a test strip and perform the test. Use the test strip immediately after removing it from the vial, especially in high humidity environments.
• Close the vial with the test strips tightly with the cap immediately after use to prevent contamination and damage to the strips.
• Store UNUSED test strips only in their original vial.
• Do not return the used test strip to the vial after testing.
• Do not reuse a test strip that has been exposed to blood or control solution. Test strips are for single use only.
• Do not perform a test with a test strip that is damaged or bent.
• You may only touch any part of the test strip with clean, dry hands. Do not bend, cut, or deform the test strip.

IMPORTANT! If another person is helping you perform the test, the meter, lancing device, and cap must always be cleaned and disinfected before use by that person. See (User Guide (Instructions for Use), Section 4, “Cleaning and Disinfection.”

IMPORTANT SAFETY INSTRUCTIONS

• The glucose meter and lancing device included in this system are intended for use by a single patient only. Do not share them with other people, even members of your family! Do not use them for multiple patients!
• After use and blood application, all parts of this kit are considered biohazardous. Used components of the system can become a source of infectious diseases even after cleaning and disinfection.

Measuring blood glucose levels: Please read the complete information in the User Guide (Instructions for Use) for the blood glucose meter, section 2, “Measuring blood glucose levels.”

1. Prepare the lancing device.
2. Insert the test strip into the glucose meter (in the test strip insertion slot) – the device will turn on automatically.
3. Obtain a blood sample from the tip of your finger – a rounded drop of blood.
4. Apply the blood sample to the test strip – carefully touch the upper edge (cut) of the test strip capillary to the drop of blood. The drop of blood will be drawn into the channel (capillary). Do not remove the test strip from the drop of blood until the confirmation window is completely filled. 
5. If the confirmation window is filled, it means that enough blood has been applied - a countdown screen will appear. Now you can remove the test strip from the drop of blood
and wait for the glucose meter to finish counting (about 5 seconds (sec)).
6. Viewing the result. Your result will appear on the screen along with the unit of measurement. After the blood glucose result appears on the screen, a range indicator arrow will appear below it, indicating where your result is: below, above, or within the normal range (see “Range Indicator Function” in Section 1 of the Glucose Meter User Guide (Instructions for Use)). The arrow points to the corresponding part of the color scale of the range indicator on the glucose meter; this is an additional visual cue.
7. Turning off the glucose meter – there are two ways to turn off the glucose meter: remove the test strip; or leave the glucose meter for two minutes and it will turn off automatically.

ATTENTION! Make sure that the glucose meter display shows the measurement unit mmol/l. If the display shows the measurement unit mg/dl instead of mmol/l, stop using the glucose meter and contact Customer Service. 

IMPORTANT! If you receive an error message, low/high blood glucose level/temperature, or other messages on the meter display instead of the result, see “Troubleshooting” in Section 6 of the meter User Guide (Instructions for Use).

WARNING!

Do not make immediate treatment decisions based on the range indicator arrow. Treatment decisions should be based on the numerical result and the recommendations of a healthcare professional, not solely on the range in which your result falls on the meter.

DISCLAIMER! 

Do not use the OneTouch Select Plus Simple® system if you know or suspect that the patient's whole blood sample contains PAM (pralidoxime), as this may lead to inaccurate results. 
A hematocrit (percentage of blood composed of red blood cells) that is either very high (above 55%) or very low (below 30%) may cause false results. 
Do not use test strips if the vial is damaged or has been left open. This may result in error messages or inaccurate results. Contact Customer Service immediately if the test strip vial has been damaged. Customer Service contact information is provided at the end of this User Guide (instructions for use). If you are unable to perform the test due to problems with any component of this system, contact your healthcare professional. Remember that timely testing will help you get the right treatment and avoid serious medical conditions. 
Do not use test strips after the expiration date printed on the vial.

DISCLAIMER!

To reduce the likelihood of infection and spread of blood-borne diseases: 
Before taking a blood sample, be sure to wash the sampling site with warm water and soap, rinse it, and dry it thoroughly. 
The lancing device is intended for use by one person only. Never give your lancet or lancing device to anyone else. 
Always use a new sterile lancet for each test. 
Always keep the meter and lancing device clean. (See the “Cleaning and Disinfection” section.) 
The meter and lancing device are intended for use by one patient only. Do not share them with other people, even members of your family! Do not use them for multiple patients! 
After use and blood application, all parts of this system are considered biohazardous. The used system can become a source of infectious disease transmission
even after cleaning and disinfection.
Do not use lancets after the expiration date indicated on the package.

If you encounter any problems or have any questions while using any components of the OneTouch Select Plus Simple® Blood Glucose Monitoring System, or if your meter stops working or develops a defect, please contact Customer Service. LifeScan Customer Care: 0 800 500 353 (free of charge in Ukraine), Monday–Friday, 9:00 a.m.–6:00 p.m.

LifeScan Europe GmbH, Dammstrasse 19 6300 Zug, Switzerland.

Authorized representative of the manufacturer in Ukraine:

Universal Agency Pro-Pharma LLC, 9 Peremohy St., office 20, Kyiv, 3170, Ukraine.