Blood Glucose Monitoring System
Easy to Use. Results You Can Trust.

Read Me First!

Starter Guide
Setting up your meter Taking a test
Starter Guide (This Guide) This starter guide is designed to walk you through your first test with the OneTouch Select system. Setting up your meter Taking a test (fingertip)
Owners Booklet Includes more detailed information, plus: Care and maintenance/ Reviewing past results Battery Alternate site testing ownloading results to a Error and other messages D Details about your computer system Control solution testing Please read the detailed instructions in your OneTouch Select Owners Booklet carefully.
Package Inserts Detailed information about your test strips and control solutions

Setting up your meter

1. Have these things ready when you test
OneTouch Select Meter (battery included)

Carrying Case

OneTouch UltraSoft Sterile Lancets OneTouch Lancing Device OneTouch Select Test Strips (sold separately)
2. et to know your meter G
ress OK for two P seconds to turn the meter on and get to the main menu. ress and release P OK to save your selections. ress OK for three P seconds to turn the meter off.
Press or to scroll between menu options and highlight your choice.
3. et the meter language, date and time S
When you turn the meter on for the first time, the SETTINGS screen will appear on the meter display. If your settings are not correct, highlight CHANGE and press OK.
Now, press or to highlight the language of your choice and press OK.
In the DATE AND TIME screen, press or to change the year and press OK. Repeat these steps to set the month and day.
Next, press or to set the hour and press OK. Repeat these steps to set the minutes and AM or PM. If the settings are correct press OK to save them. If they are not correct, highlight CHANGE and press OK to start over.
Confirm that the correct unit of measure mg/dL is displayed here.

4. Code the meter

Matching the code on the meter and the code on the test strip vial is essential to obtaining accurate results.
Find the code that is printed on the test strip vial. Insert a test strip this way to turn the meter on and display the code from your last test.
A flashing will appear on the display the first time you use your meter.
Press or to change the code on the meter to match the code on the test strip vial. Then, press OK. If the codes already match, press OK to proceed to testing. When no button is pressed after five seconds, the display will advance to the APPLY SAMPLE screen.
Taking a test (fingertip)
Before testing, be sure to wash your hands and the puncture site.
1. repare the P lancing device
Remove the blue cap by snapping it off.
Insert a sterile lancet, twist off the protective disk and snap the cap back on.

2. Get a blood drop

Adjust the depth setting by twisting the cap. Larger numbers are for deeper punctures. Slide the cocking control back to cock the lancing device.

Puncture your finger.

See the Owners Booklet for complete information on using the OneTouch Lancing Device and on alternate site testing.
Obtain a drop of blood. Massage or squeeze your fingertip as needed.
Do Not use a blood sample that smears or runs.
3. pply blood drop to test strip A
Move the meter and the test strip toward the blood drop.
Do Not hold the meter and test strip underneath the blood drop.
Line up the blood drop with the inner narrow channel on the test strip.

Narrow Channel

Gently touch the channel to the blood drop.
Do Not apply blood on the top of the test strip.
4. ait for your result to appear on the meter W
Blood will be drawn into the test strip and the confirmation window will fill completely. Move the test strip away from the blood drop and wait for the meter to count down from 5 to 1.
Be careful not to push the test strip against your fingertip or the test strip may not fill completely. If the blood sample does not fill the confirmation window completely, you may get an ERROR 5 message or an inaccurate result. Discard the test strip and start again with a new test strip.
Read your result on the meter.
See the Owners Booklet for instructions on what to do if you get results that are higher than, lower than, or not what you expect.
Turn off your meter. Remove the test strip or press OK for three seconds.

5. ispose of your used D test strip and lancet
When you remove the used test strip, be sure to dispose of it properly. Cover the exposed lancet tip with the protective disk. Then, remove the lancet and place it in a container for sharp objects.

(Example)

Congratulations! You have successfully completed a glucose test with your OneTouch Select Meter.

Additional resources

www.LifeScan.com
Customer Service 227-8862
Call Customer Service toll-free, 24 hours a day, 7 days a week English 227-8862 Espaol 381-7226 Or Visit us at www.LifeScan.com
Manufactured for: LifeScan, Inc. Milpitas, CA 95035 USA 2007 LifeScan, Inc. Milpitas, CA 95035 Rev. date: 9/2007

AW06486201A

DCO_06487301A_OTS_TSI_US

9/20/07

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Test Strips
For whole blood glucose testing with the OneTouch Select Meter. IMPORTANT: Please read this information and your OneTouch Select Meter Owners Booklet before using OneTouch Select Test Strips. Do Not use your OneTouch Select Test Strips if your vial is open or damaged in any way as this could lead to error messages or blood glucose values that read higher than the actual value. Call LifeScan Customer Service at 227-8862 immediately if the test strip vial is open or damaged or if these instructional materials or your meter results seem unclear.

Blood Sample Collection

NOTE: Refer to your systems owners booklet for detailed information on preparing the lancing device and blood sample collection. To obtain a drop of blood, follow these steps: Step 1: Select the puncture site. You may obtain a blood drop from the fingertip, palm, or forearm. Wash your hands and the puncture site with warm, soapy water. Dry them thoroughly. Step 2: Lance the puncture site. Obtain a drop of blood. Do Not squeeze the puncture site excessively.

Intended Use

OneTouch Select Test Strips are used with the OneTouch Select Meter for quantitatively measuring glucose in fresh capillary whole blood. The OneTouch Select Test Strips and meter are intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home and health care professionals in the clinical setting, as an aid to monitor the effectiveness of diabetes control. OneTouch Select Test Strips and meter are for use on the finger, palm, and forearm.
Choosing the Right Sampling Site at the Right Time
At times, results obtained at the forearm or palm may be different from a fingertip measurement. Talk to your health care professional before you begin using your forearm or palm for sampling. NOTE: Confirm if you have the correct cap for alternate site testing. If you are testing: Use blood sample from your: Fingertip, forearm, or palm Fingertip, forearm, or palm

Storage and Handling

Flip Top Vial
Routinely before meals Prior to or more than two hours after: a meal a rapid-acting insulin injection or insulin pump bolus exercise When your blood glucose is changing rapidly, such as: within two hours after a meal within two hours after a rapid-acting insulin injection or insulin pump bolus, or during or within two hours after exercise When you are concerned about the possibility of hypoglycemia
Store the test strip package in a cool dry place not above 86F (30C). Do Not refrigerate. Keep away from direct sunlight and heat. Exposure to temperatures and/or humidity outside the required storage conditions may result in inaccurate readings. Store your test strips in their original vial only. To avoid damage or contamination, Do Not transfer test strips to any other place. Do Not open test strip vial until you are ready to test. After removing a OneTouch Select Test Strip from the (Example) vial, immediately replace the vial cap and close it tightly. Use each test strip immediately after removing it from the vial. Do Not use test strips from any vial that is damaged or left open to air. Write the discard date (3 months after first opening the vial) on the vial label when you first open it. Do Not use test strips beyond the expiration (printed on package) or discard date, whichever comes first, because they may cause inaccurate results. Avoid getting dirt, food, or liquids on the test strip. With clean, dry hands, you may touch the test strip anywhere on its surface. Do Not bend, cut, or alter a OneTouch Select Test Strip in any way. OneTouch Select Test Strips are for single use only. Never reuse a test strip that had either blood or control solution applied to it. Make sure your meter and test strips are about the same temperature before you test. Apply only OneTouch Select Control Solution or a blood sample to the test strip. After performing a test, Do Not return the used test strip to the vial.

Fingertip Fingertip

CAUTION: Do Not test on forearm or palm when:
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.
Precautions to Obtain Accurate Results
Code the OneTouch Select Meter to match the code number printed on the OneTouch Select Test Strip vial.

You think your blood glucose is rapidly falling, such as within two hours of exercise or a rapid-acting insulin injection or insulin pump bolus. Testing with a fingertip sample may identify a hypoglycemic (low blood sugar) level sooner than testing with a forearm or palm sample. It has been less than two hours after a meal, a rapid-acting insulin injection or insulin pump bolus, physical exercise, or you think your glucose level is changing rapidly. You are concerned about the possibility of hypoglycemia (insulin reactions), such as when driving a car. This is especially important if you suffer from hypoglycemia unawareness (lack of symptoms to indicate an insulin reaction).
Remember: Consult with your health care professional before using your forearm or palm for testing.

Blood Glucose Testing

NOTE: For detailed information on the testing procedure including blood sample collection and coding your meter, please refer to the owners booklet that came with your system. Step 1: Insert test strip. Remove a test strip and recap the vial immediately. Insert the test strip into the test port. Make sure the three contact bars are facing you and the arrow is pointing down. Push the test strip in as far as it will go. Meter turns on automatically. Be sure the meter and test strip code match.

(Figure A - Example)

AW 06487301A
CAUTION: Matching the code on the meter and the code on the test strip vial is essential to obtain accurate results. Each time you test, check to make sure the code numbers match. (Figure A)
Check that the meter is showing the correct unit of measure before each test. The unit of measure is either mg/dL or mmol/L. Refer to the owners booklet for the correct unit of measure. If the unit of measure is not correct, call 227-8862. Use only OneTouch Select Test Strips with the OneTouch Select Meter to obtain accurate results. If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all instructions described in your OneTouch Select Meter Owners Booklet, call your health care professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your health care professional.
Step 2: Apply sample. When the flashing apply sample symbol appears on the display, touch and hold the drop of blood to the narrow channel in the top edge of the test strip. Keep holding the blood drop to the top edge of the test strip until the confirmation window is full. Do Not apply sample to the top of the test strip. Do Not move the test strip in the meter during a test. Do Not press the test strip against your puncture site (fingertip, forearm, or palm). Do Not apply a smeared sample. If the confirmation window does not fill completely before the meter begins to count down, Do Not add more blood to the test strip; discard the test strip and retest. If the confirmation window is not full, you may get an error message or an inaccurate test result. If you have trouble filling the test strip, contact LifeScan Customer Service for assistance. Step 3: Accurate results in just 5 seconds. Your blood glucose test result will appear after the meter counts down from 5 to 1.

Test Procedure for Blood Glucose Measurement
Materials provided: OneTouch Select Test Strips. Materials required but not provided: your meter, owners booklet, lancing device, optional clear cap, and a new, sterile lancet.
WARNING: Check that the unit of measure is correct (mg/dL).
If the unit of measure is not correct, call 227-8862.

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Test Results
The OneTouch Select Meter displays results between 20 and 600 mg/dL (1.133.3 mmol/L). If your test result is lower than 20 mg/dL (1.1 mmol/L), a warning message will appear indicating a low glucose level. This may indicate severe hypoglycemia (low blood glucose). Treat this condition immediately according to your health care professionals recommendations. Although this message could be due to a test error, it is safer to treat first, then do another test. If your test result is above 600 mg/dL (33.3 mmol/L), a warning message will appear indicating a high glucose level. This may indicate severe hyperglycemia (high blood glucose). You should retest your glucose level and if the message appears again, call your health care professional immediately.
CAUTION: To reduce the chance of infection: Never share a lancet or the lancing device with anyone. Always use a new, sterile lancet. Lancets are for single use only. Keep your meter and lancing device clean. Make sure to wash the puncture site with soap and water before testing.

Test Principle

The OneTouch Select System is plasma-calibrated to allow easy comparison of results with laboratory methods. Glucose in the blood sample mixes with special chemicals on the test strip and a small electrical current is produced. This current is measured by the OneTouch Select Meter and displayed as your blood glucose result. The strength of this current changes with the amount of glucose in the blood sample.

Range of Expected Values

Blood glucose management requires the help of a health care professional. Together you can set your own range of expected blood glucose values, arrange your testing times, and discuss the meaning of your blood glucose results. Expected blood glucose levels for people without diabetes:1 Time Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 and 4 am Range, mg/dL Less than 160 Less than 120 Greater than 70 Range, mmol/L 3.95.8 3.96.1 Less than 8.9 Less than 6.7 Greater than 3.9

Reagent Composition

Each OneTouch Select Test Strip contains: Glucose oxidase (Aspergillus niger) 0.08 IU; ferricyanide 22 g; other ingredients (buffer, etc.). The vial contains a drying agent.

Performance Characteristics
The performance of OneTouch Select Test Strips has been evaluated both in laboratory and in clinical tests.3 Measurement range: The measurement range of the OneTouch Select System is 20 to 600 mg/dL (1.133.3 mmol/L). Clinical accuracy: The accuracy of the OneTouch Select System was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300 Glucose Analyzer, a laboratory instrument. The following results were obtained by 163 diabetic patients at 3 clinical centers: Slope 0.979 y-intercept -3.4 mg/dL (-0.2 mmol/L) Correlation coefficient (r) 0.985 No. of samples 163 Range tested 43486 mg/dL (2.427.0 mmol/L) This study shows that the OneTouch Select Meter compares well with a laboratory method.3 Precision: Within Run Precision Bloodav 42 mg/dL (2.3 mmol/L) Bloodav 106 mg/dL (5.9 mmol/L) Bloodav 139 mg/dL (7.7 mmol/L) Bloodav 224 mg/dL (12.4 mmol/L) Bloodav 355 mg/dL (19.7 mmol/L) Control 36 mg/dL (2.0 mmol/L) Control 110 mg/dL (6.1 mmol/L) Control 337 mg/dL (18.7 mmol/L) CV = 3.0% CV = 1.8% CV = 1.5% CV = 1.5% CV = 1.6% CV = 3.2% CV = 2.1% CV = 2.3%
If You Get Unexpected Results: If your blood glucose result is less than 70 mg/dL (3.9 mmol/L) indicating low blood glucose or higher than 180 mg/dL (10.0 mmol/L) indicating high blood glucose, you should contact and follow your health care professional treatment advice.2 If you continue to get unexpected results, check your system with control solution. If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all instructions described in your owners booklet, call your health care professional. Never ignore symptoms or make significant changes to your diabetes control program without speaking to your health care professional.

Checking the System

Use only OneTouch Select Control Solutions For complete details about checking the system, refer to your owners booklet. When to do a Control Solution Test: At least once a week When you begin using a new vial of test strips Whenever you suspect that the meter or test strips are not working properly If you have had repeated unexpected blood glucose results If you drop the meter If control solution test results fall outside of the range printed on the test strip vial, repeat the test and refer to your owners booklet.

Total Precision

CAUTION: If you continue to get OneTouch Select Control Solution test results that fall outside the range printed on the vial, your meter may not be functioning properly. Do Not use the meter to test your blood until you get a control solution test result that falls within the range. If you continue to have problems, call 227-8862.
This study shows a variability from test strip to test strip in blood tests of 3.0% or less. IMPORTANT: For a complete description of operating instructions and other important technical information, please refer to the owners booklet that came with your system. IF YOU HAVE QUESTIONS ABOUT THE USE OF ANY LIFESCAN PRODUCT, PLEASE CONTACT LIFESCAN CUSTOMER SERVICE AT 227-8862.

Limitations of Procedure

OneTouch Select Test Strips give accurate results when the following limitations are observed: Do Not use for the diagnosis of diabetes or the testing of newborns. The test strips are for single use only. Do Not reuse. 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. Hematocrit is the percentage of red blood cells in the blood. Extremes in hematocrit may affect test results.3 Hematocrit levels less than 30% may cause falsely high readings and hematocrit levels greater than 55% may cause falsely low readings. If you do not know your hematocrit level, consult your health care professional. OneTouch Select Test Strips may be used at altitudes up to 10,000 feet (3048 meters) without an effect on test results. Accurate results were demonstrated in clinical studies performed at altitudes up to 5,280 feet (1609 meters) and in studies simulating altitudes up to 10,000 feet (3048 meters). Health care professionalsplease note these additional limitations of procedure: Fresh capillary blood may be collected into heparin-containing test tubes if the blood is used within 10 minutes. Do Not use other anticoagulants or preservatives. Interferences: Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C), and other reducing substances (when occurring in normal blood or normal 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 by blood glucose meters. Lipemic samples: Cholesterol levels up to 700 mg/dL (18.1 mmol/L) and triglycerides up to 3000 mg/dL (33.9 mmol/L) do not affect the results. Grossly lipemic patient samples have not been tested and are not recommended for testing with the OneTouch Select Meter.

References

1. Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), p. 138. 2. Beaser, R.S. and Hill, Joan: The Joslin Guide to Diabetes. New York: Simon and Schuster (1995), p. 158. 3. Data on file. OUR COMMITMENT TO YOU: Our goal is to provide you with quality health care products and dedicated customer service. If you are not fully satisfied with this product, contact your authorized LifeScan representative at 227-8862.

Infection Control

Use universal blood precautions when handling, and disposing of, blood glucose monitoring materials. All patient samples and materials with which they come in contact are considered biohazards and should be handled as if capable of transmitting infection. Follow proper precautions in accordance with local regulations when disposing of all materials.
Covered by one or more of the following U.S. patents: 5,708,247, 5,951,836, 6,241,862, 6,284,125, and 7,112,265. Use of these test strips and associated monitoring device is protected under the following U.S. patents: 6,413,410, 6,733,655. Purchase of the associated monitoring device does not act to grant a use license under these patents. Such a license is granted only when the associated monitoring device is used with OneTouch Select Test Strips. No test strip supplier other than LifeScan, Inc. is authorized to grant such a license. The accuracy of results generated with LifeScan meters using test strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan.
AW 06487301A 2007 LifeScan, Inc.
Distributed by: LifeScan, Inc. Milpitas, CA 95035 Rev. date: 08/2007