GLUCOMETER ELITE

Glucometer Elite Blood Glucose Test Strips and Code Strip
For Use with Glucometer Elite" Blood Glucose Meter To Test For Glucose in Whole Blood

SUMMARY
Glucometer Elite Blood Glucose Test Strips quantitatively measure glucose in whole blood and are designed for use with the Glucometer Elite Blood Glucose Meter only. When the tip of the Test Strip touches a drop of blood, the strip fills automatically through simple capillary action. The blood is drawn into a reaction chamber and a reading is displayed on the meter. Only a small amount of blood is needed and no wiping or blotting is required. The test provides a quantitative measurement of glucose from 1.1 to 33.3 mmol/L (20 to 600 mg/dL).

A Glucometer Elite Code Strip is provided with each package of Test Strips. Each Code Strip has a specific Code Number (Function Number). When the Code Strip is inserted, the meter is automatically calibrated. When you calibrate, you set the electronic system in the meter to match the reactivity of that specific package of Test Strips. By setting the electronic system, you match the meter system to the Test Strip to give accurate test results. Each package of Test Strips contains its own Code Strip. The Code Strip is inserted into the Test Strip slot and when the "F-#" is displayed, coding (calibration) is complete. It is important that the Function Number set in the meter matches the Code Strip number for the package of Test Strips in use.
NOTE: # indicates a number between 0 and 12.

TESTING PROCEDURE
Code Strip Procedure:
Materials required: Glucometer Elite Meter and Code Strip

Procedure:

1. Insert Code Strip fully into the Test Strip slot. (Two beeps will sound and an F-# will appear on the display)
2. Remove the Code Strip. Your meter is now ready for blood glucose or control testing.

Test Strip Procedure:
Materials required: Glucometer Elite Meter and Test Strip

Procedure:

1. Insert the Test Strip into the meter. (The F-Number that flashes on the display should match the F-Number on the foil pouch.)
2. Touch and hold the test end of the Test Strip to a drop of blood until after the meter beeps.

See your Glucometer Elite Blood Glucose Meter User Guide for detailed illustrated directions for both procedures.

CHEMICAL COMPOSITION
29.1% w/w glucose oxidase (Aspergillus niger, 20 U/mg)
32.0% w/w potassium ferricyanide
38.9% w/w nonreactive ingredients

PRECAUTIONS

• For in vitro diagnostic use (external use only).
• The Glucometer Elite Blood Glucose Meter has been optimized for use with Glucometer Elite Test Strips. The performance characteristics of the Meter may not be valid for any other brand of Test Strips. The use of other Test Strips may cause erroneous results Bayer Corporation does not warrant the use of the Glucometer Elite Blood Glucose Meter with any Test Strip other than Glucometer Elite Test Strips.
• Warning: Potential Biohazard: Healthcare professionals or persons using this system on multiple patients should be aware that all products or objects that come in contact with human blood, even after cleaning, should be handled as if capable of transmitting viral diseases. For further information, see the Glucometer Elite User Guide.*
• Do not ingest desiccant bead sealed in foil packet.
• Altitudes up to 8800 ft. do not significantly affect Glucometer Elite test results.

STORAGE AND HANDLING
Do not use Test Strips after expiry date.
Strips may give false test results if used beyond the expiry date.

To keep Test Strips fresh, follow these recommendations carefully:

• Store at temperatures between 59º-86ºF (15º-30ºC).
• Store away from direct sunlight.
• Allow time for Meter and/or Test Strips to come to room temperature before use.
• Use the Test Strip immediately after opening the foil packet.
• Either end of the Test Strip may be held before inserting into Meter without contamination.

PRINCIPLES OF THE PROCEDURE
The Glucometer Elite blood glucose test is based on measurement of electrical potential caused by the reaction of glucose with the reagents on the electrode of the strip. The blood sample is drawn into the tip of the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide. Electrons are generated producing a current which is proportional to the glucose in the sample. After a specific reaction time for your meter, the glucose concentration in the sample is displayed.

SPECIMEN COLLECTION AND PREPARATION
Sufficient blood to perform the test may be obtained from the fingertip. Preparation of the puncture site is important. The puncture site should be cleaned with mild soap and warm water - then rinsed and dried thoroughly before testing. If alcohol is used to wipe the puncture site, make sure the site is completely dry before pricking the finger. If desired, a venous whole blood sample may be used. A venous whole blood sample usually reads higher than a capillary sample from the same person (approximately 7% higher on average with normal glucose samples) due to the unique electrochemical properties of the Glucometer Elite Test Strip. Use venous blood within 30 minutes after drawing. Comrnon anticoagulants (potassium oxalate, heparin and EDTA) may be used.

QUALITY CONTROL
WHY: To check performance of the meter, Test Strip and your testing technique (applying sample to Test Strip). The meter, Test Strip and your testing technique are acceptable if the Control Test result falls within the specific control range listed on the end flap of your Glucometer Elite Test Strip carton.
IMPORTANT: Because Control Ranges can change for each new lot of Test Strips, always use the Control Ranges on the end flap of your current carton of Test Strips.
HOW: Run a Control Test by following the illustrated Control Test directions in the Glucometer Elite User Guide.
WHEN: Any time you want to check the performance of your meter, Test Strip or testing technique.
IMPORTANT: Performance is assured only when the Control Test result falls within the specific range listed on the end flap of your Glucometer Elite Test Strip carton. Bayer recommends that individuals run a Control Test and consult with their physician or healthcare professional before adjusting medication based an Glucometer Elite test results. In hospital use, follow the approved directives of your institution.

TEST RESULTS
Test results are displayed in the meter display window in either milligrams of glucose per decaliter (mg/dL) or millimoles of glucose per liter (mmol/L). No calculation is necessary. The mmol/L results will always include a decimal point; mg/dL results do not include a decimal point.

When Test Results are Questionable or Inconsistent:

1. Be sure the drop of blood completely filled the tip of the Test Strip.
2. Confirm that strips are within the expiry date.
3. Be sure you have calibrated your meter by setting the correct Function Number (i.e., the Code Strip Number for the package of Test Strips in use).
4. Check meter performance using Glucometer Elite Check Strip.
5. Check meter and strip performance using Glucometer Elite Controls.

Comparison Options:
Whole Blood Methods: Note that glucose concentrations drop rapidly due to glycolysis (approximately 7% per hour).** For test result comparison, compare with other whole blood methods. Because glucose concentrations change rapidly (within minutes), this comparison must be done simultaneously from the same sample.

LIMITATIONS OF THE PROCEDURE

1. PRESERVATIVES:
   - Fluoride - Do not use fiuoride as a preservative for blood specimens.
   - lodoacetic acid - Do not use iodoacetic acid as a preservative for blood specimens.
2. ARTERIAL SPECIMEN: Arterial specimens with P02 of >200 mmHg had a small bias (average of -6%) on the Glucometer Elite in comparison to the laboratory method glucose results. The reference range for arterial P02 is 80 to I 1 0 mmHg (11.04 to 14.36 kPa).
3. NEONATAL USE: The Glucometer Elite XL System is the only Glucometer Elite System qualified for neonatal use. It is intended for monitoring treatment of hypoglycemia in neonates. The Glucometer Elite XL System is not intended for diagnosis of neonates for hypoglycemia. Do not use any other Glucometer Elite Blood Glucose Meter for neonatal testing.
4. METABOLITES: Reducing substances such as ascorbic acid and uric acid at normal blood concentrations do not significantly affect Glucometer Elite blood glucose test results.
5. HEMATOCRIT. At normal glucose levels, Glucometer Elite Test Strip results are not significantly affected by hematocrits in the range of 20% to 60%. At glucose levels above 300 mg/dL (1 6.7 mmol/L), hematocrit levels above 55% will cause lowered results. For Neonatal Use: At glucose levels between 20 mg/dL (1.1 mmul/L) and 120 mg/dL (6.7 mmol/L), Glucometer Elite XL results are not significantly affected by hematocrit levels in the range of 20% to 70%.
6. LIPAEMIC SPECIMEN: Cholesterol up to 13.0 mmol/L (500 mg/dL) or triglycerides up to 33.9 mmol/L (3000 mg/dL) do not significantly affect the results. Glucose values however, in specimens beyond these levels should be interpreted with caution.

CONTRAINDICATION (Bayer advises against); Capillary (fingerstick) blood glucose testing may not be clinically appropriate when peripheral blood flow is decreased. Shock, severe hypotension, hyperosmolar hyperglycemia and occurrence of severe dehydration are examples of clinical conditions which may adversely affect the measurement of glucose in peripheral blood.***

AVAILABILITY: See your Glucometer Elite User Guide for the availability of accessory items.

PATENTS
Covered by US Patents: 5,120,420 and 5,320,732, and foreign equivalents.

REFERENCES
*. Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood, Body Fluids, and Tissue; Approved Guideline. NCCLS document M29-A (ISBN 1-56238-339-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 1997.
**. Tietz N.: Fundamentals of Clinical Chemistry, 3rd Ed., W B. Saunders Co., Philadelphia, PA, 1987, p. 427,
***. Atkin S.. Jaker MA, Chorost Ml, Reddy S.: Fingerstick Glucose Determination in Shock. Annals of Internal Medicine, 1991, 114:1020-24.