Owner's Booklet
  Prestige Smart System^TM Glucose Control Instructions for Use
  Prestige Smart System^TM Blood Glucose Test Strips Directions for us
  Lancing Device

Prestige Smart System^TM Glucose Control Instructions for Use

Indended Use
Prestige Smart System Glucose Control is a liquid that contains a known amount of glucose. This Control is meant for use with any Prestige Smart System Blood Glucose Meter.

Test Principle
When a drop of Prestige Smart System Glucose Control is a applied to a Prestige Smart System test Strip, it reacts like a drop of blood. The user is able to check testing technique and System performance by checking the value displayed in the Meter against the range of Glucose Control values given. If the Meter value falls within the range of values given, test results using whole blood will be correct.

Storage and Handling
Prestige Smart System Glucose Control should be stored upright tightly sealed, at ROOM TEMPERATURE between 590 and 860F (150 - 300C). DO NOT REFRIGERATE OR FREEZE. Keep away from direct sunlight. DO NOT use after the expiration date printed on the package or beyond two months after the bottle is opened. Mark each bottle with the date it was opened. Throw away any unused Control that is two months beyond that date.

Reagents
Chemicals Composition: One 2 mL bottle of Prestige Smart System Control contains dextrose (glucose), stabilizers, preservatives, buffers and dyes. The low Control contains 70 mg/dL glucose. The high Control contains 250 mg/dL glucose.

Precautions

For in vitro (external) diagnostic use only. This product is not meant to be consumed or injected. Do not use beyond the expiration date.

Test Procedure

Before using a new bottle of Control solution, mark the bottle with the current date.

To perform a Control test, use Prestige Smart System Control solution instead of whole blood. Apply Control solution to the Test Spot of a Prestige Smart System Test Strip, just as a drop of whole blood would be applied to the Test Strip.

To Perform a Prestige Smart System Glucose Control Test:

1. TURN THE METER ON AND BE SURE THAT THE CALIBRATION CODE PRINTED ON THE TEST STRIP VIAL
    MATCHES THE CODE DISPLAYED IN YOUR METER.

2. Please See Section 3 of your Owner's Booklet for detailed instructions regarding control testing.

3. Swirl the control a `few times before using. DO NOT SHAKE.

4. Remove the screw cap from the control bottle. Hold the bottle upside down, about ½ inch above the Test Strip.

5. SLOWLY squeeze the bottle to form a round drop at the end of the dropper tip. Apply ONE DROP of control onto the
    center of the Test Spot. DO NOT touch the Test Spot with the dropper tip. DO NOT apply more than one drop of`control to
    the Test Spot. DO NOT allow the part of the drop to be drawn back into the bottle. If there are bubbles in the drop of
    control that is applied to the Test Spot, throw away the Test Strip and repeat the Test with a new Strip.

6. Turn the Test Strips over and check the Color Spot to en sure that you applied enough Glucose Control. Look for full color
    development throughout the entire Color Spot area.

7. Slide the Test Strip into the Meter.

8. At the end of the Control test, compare the value displayed in the Meter with the
    Control Range found either on the Prestige Smart System Test Strip Box or Test Vial Label.

9. Control Test results should always be within the Control Range given for the lot of Prestige
    Smart System Test Strips being used. It Control results are outside this range, follow steps
    under "Troubleshooting" below.

Expected Values

Control Ranges for the Prestige Smart System are located on the Prestige Smart System Test Strip Box and on the Test Strip Vial Label.

Troubleshooting

If a Control test results is outside the Control Range, follow these steps:

1. Check to see if the Control or Test Strip has expired. Replace any expired Control or Test Strips.

2. Be sure that the Code displayed in the Meter is the same as the Calibration Code printed on the vial of Test Strips being
    used. If not, see Section 2 of your Prestige Smart System Owner's Booklet form details on coding on your Meter.

3. Please see Section 3 of your Owner's Booklet for complete detailed instructions on performing a Glucose Control Test.

4. Check the Test Spot of an unused Test Strip for discoloration. This may mean that the Strips are contaminated or have
    been exposed to extreme temperatures or humidity. If this is the case, discard the Test Strips and replace them with a
    new Test Strip vial.

5. After applying Glucose Control to the Strip, inspect the Color Spot of the Test Strip. If the entire area does not show full
    color development (not enough Control) or appears "wet" (too much Control) discard the Test Strip and repeat the test
    using a new Strip. Be sure to check the Color Spot again before inserting the Strip into the Meter. If the Control result is
    still outside the range of values given, go to Step 6.

6. Refer to the Troubleshooting Section of your Prestige Smart System Owner's Booklet for information on how to ensure
    your Meter is working properly.

Quality Control (QC) Testing (Glucose Control and Standard Strip)

For Home Users:

QC Testing should be performed

· Before using the Meter for the first time.
· When a new vial of Prestige Smart System Test Strips is opened.
· When your results do not agree with the way you feel.
· When you suspect a problem with the Meter / System.
· When you want to check your testing technique.
· After you have removed and replaced the Test Strip Platform (ALWAYS run a Standard Strip Test)

The Prestige Smart System Standard Strip is a hard plastic strip supplied with each Prestige Smart System Meter. It is used to make sure that the Meter is working the way it should. (The Standard Strip does not have a lot number of expiration date). When you run the test with the Standard Strip, the test result should fall within the range printed on the Standard Strip label. See Section 3 of your Prestige Smart System Owner's Booklet for complete testing details.

For Institutional Users:

Details on QC testing, System maintenance and System storage can be found in the Prestige Smart System QA Manual.

Limitations
Prestige Smart System Glucose Control is not meant to be used as a calibrator. The procedure for calibrating the System can be found in Section 2 of the Prestige Smart System Owner's Booklet.

Technical Pointers
As with whole blood testing, accurate results using Prestige Smart System Control require good testing technique. The pointers listed below will help you get accurate Control results:

1. Place one full drop of Glucose Control onto center of the Test Spot of Test Strip. DO NOT allows part of drop to be drawn
    back into the bottle. Of there are bubbles in the drop of Control after it is applied to the Test Spot, throw away the Strip
    and repeat the test with a new Test Strip.

2. DO NOT apply more than one drop of Control to the Test Spot.

3. Follow the directions in Section 3 of your Prestige Smart System Owner's Booklet precisely.

For medical assistance, please contact your Doctor or Diabetes Healthcare Professional.

Prestige Smart System is a trademark of HDI

Manufactured by:

Home Diagnostics, Inc.
Dedicated to Diabetes Management Prestige Logo

For Lauderdale, FL 33309
www.prestigesmartsystem.com

PRESTIGE SMART SYSTEMTM BLOOD GLUCOSE TEST STRIPS DIRECTIONS FOR USE

Intended Use

The Prestige Smart System families of products are intended for both professional and home use. Prestige Smart System Test Strips, when used with Prestige Smart System Blood Glucose Meters will measure glucose level in whole blood. Routine blood glucose (sugar) testing with Prestige Smart System can provide you and your Doctor with current in formation on how your treatment of program affects your blood glucose level. Testing your blood and keeping your blood glucose level under control can help keep your diabetes under control too. Blood glucose testing should be done under the guidance of your Doctor or Diabetes Healthcare Professional.

Expected whole blood glucose level for people without diabetes:1

If you are not known to have diabetes and your whole glucose remains below 60 mg/dL2 (3.3 mmol/L) or above 240 mg/dL3 (13.3 mmol/L), CONTACT YOUR DOCTOR.

Product Description
The Prestige Smart System Test Strip is a plastic strip that changes color as it reacts with the glucose in a drop of whole blood. The Prestige Smart System Blood Glucose Meter measures the color and displays your blood glucose test result.

Important parts of the Prestige Smart System TEST STRIP are as follows:

1. Test Spot: A small "circle" on the FRONT of the Test Strip, where you must
    apply your blood sample. This circle is shown by an arrow and a blood drop.

2. Color Spot: A small "circle" on the BACK of the Test Strip. This spot changes
    color when the Strip reacts with your blood glucose.

Precautions

Use Prestige Smart System Test Strips for in vitro (external) diagnostics only. DO NOT CONSUME. Do not use the Color Spot alone (without the Meter) to measure blood glucose. This is not visual test. Before running a test using any Prestige Smart System, allow the Meter, Test Strips and Glucose Control to reach room temperature.

NEVER transfer Prestige Smart System Test Strips from one vial to another; ONLY store test Strips in their original labeled vial.

WARNING: Keep the Test Strip vial cap away from small children. A child may choke on the cap. The cap contains a drying agent that may be harmful if swallowed.

Blood Sample Collection and Preparation

To perform a blood glucose test, one drop of fresh capillary whole blood from a clean, dry finger is the preferred sample. Venous whole blood, dawn by Healthcare Professional, may also be used to perform a test with any Prestige Smart System. Please read "Clinical Testing with the Prestige Smart System" below for instructions on blood collection and preparation using venous blood.

NEVER use serum, plasma or clotted blood when testing with Prestige Smart System.

To obtain a capillary blood sample, follow these steps:

1. Wash your hands with soap and warm water. Rinse and dry your hands well. If soap and water cannot be used, your finger can be cleaned with an alcohol swab. Let your finger dry completely.

2. Using a lancing device and sterile lancet, lance your finger. Gently massage your finger to get the full, rounded drop of whole blood that will be used for blood glucose test.

How to perform a Prestige Smart SystemTM Blood Glucose Test.

Read your Prestige Smart System Owner's Booklet or call Technical Services at 1 - 800 - 446 - 7844 for complete testing details.

1. Press the power Button to turn the Meter on.

2. Check the Meter Calibration Code to match the Test Strip vial label (To change the Code, see the Owner's Booklet.)

3. Lance your finger

4. Apply one drop of blood to the Test Spot of a Test Strip.

5. After applying blood to the Test Spot, turn the Test Strip over. Check the
    Color Spot to ensure that you have applied enough blood. Look for full
    color development throughout the entire Color Spot area. If the entire area
    does not show full color development (not enough blood) or appears "wet"
    (too much blood), discard the Test Strip and repeat the test.

6. Insert the Test Strip into the Meter.

7. Record the in your Self-Test log book.

Quality Control (QC) Testing (using Glucose Control and the Standard Strip)

QC Testing should be performed:

• Before using your Meter for the first time.
• When a new vial of Test Strips is opened.
• When your results do not agree with the way you feel.
• When you suspect a problem with the Meter / System.
• When you want to check your testing technique.
• After you have removed and replaced the Test Strip Platform (ALWAYS run a Standard Strip test)

Prestige Smart System Glucose Control is used to check testing technique and System performance. Two levels of Glucose Control (low and high) can be used with the Prestige Smart System. When Glucose Control result fall within the Control Range given for the lot of Test Strips being used, the System is working as it should, and your testing technique is good. The Control Range can be found on the Strip package and on the Test Strip vial label. Read your Prestige Smart System Owner's Booklet for complete testing details.

The Prestige Smart System Standard Strip is a hard plastic strip supplied with each Prestige Smart System Meter. It is used to make sure that the Meter is working the way it should. (The Standard Strip does not have a lot number or expiration date.) When you run a test with the Standard Strip, the test result should be within the range printed on the Standard Strip label. Read your Prestige Smart System Owner's Booklet for complete testing details.

Unusual Test Results

You may get a blood glucose test result that seems too high or too low. Te test result may not agree with the way you feel. If this happens, there may be a problem with your Meter, Test Strips or your testing technique. Try to find out if there is a problem, then repeat the test with a new Test Strip.

Results that seem too high or low may be due to the reasons below:

1. Too little or too much blood was applied to the strip. After applying blood to the Test Spot, turn the Test Strip over. Check the Color Spot to ensure that you have applied enough blood. Look for full color development throughout the entire Color Spot area. If the entire area does not show full color development (not enough blood) or appears "wet" (too much blood), discard the Test Strip and repeat the test using a new Strip. Be sure to check the Color Spot again before inserting the Strip into the Meter. Too little or too much blood can give false glucose reading.

2. The Test Strips are expired. Check the Test Strip vial label to be sure the expiration date has not passed. If the Test Strips have expired, throw them away and replace them with a new vial of Strips.

3. The Test Strips are damaged - perhaps because the vial was fully recapped, or because the Strips were stored in extreme heat or cold. Replace the Strips as needed.

4. The Meter Code does not match the Calibration Code printed on the Test Strip vial label. Change the Meter Code if needed. Follow the steps described in your Prestige Smart System Owner's Booklet.

5. Steps for maintaining and cleaning the Meter have not been follows as described in the Prestige Smart System Owner's Booklet. Read Section 7 of the Owner's Booklet, taking care to follow all the steps listed.

LANCING DEVICE:

Instructions for the Lancing Device

This Lancing Device is used to obtain capillary blood samples needed for blood glucose monitoring or for other tests requiring one or two drops of blood. The Adjustable Comfort Tip on the Lancing Device allows you to choose the best depth of skin penetration. To obtain a drop of blood, first wash your hands with warm, soapy water. Dry your hands thoroughly before using the Lancing Device.

Directions

1. Twist off the Lancing Cover.	4. Replace the Lancing Device Cover.
2. Insert a new Lancer firmly into the Lancet Carrier.	5. The Adjustable Comfort Tip offers 5 levels of skin penetration. To select the desired depth, twist the Adjustable Comfort Tip in either direction until the number lines up with the Arrow.
3. Pinch the Lancet Disk Cover and gently twist it off of the Lancet.	To select the best depth:      * 1 - 2 for soft or thin skin.      * 3 for average skin      * 4 - 5 for thick or calloused skin. NOTE: For even finer adjustment, the Arrow may be lined up between any two numbers.
6. Hold the Lancing Device Cover in one hand. Using the other hand, slowly pull the Sliding Barrel away from the Lancing Device Cover. You will hear a click, indicating that the Lancet Carrier is locked in to position. Release the Sliding Barrel to return it to its original position.	7. Position of the end of the Adjustable Comfort Tip against the tip of the finger. Press the Trigger Button, and then lift the Lancing Device away from the finger after the puncture is complete.

8. Place the Lancing Device aside and wait a few seconds for a blood drop to form. To help form a blood drop, lower the hand to waist level and gently massage the finger from palm to fingertip.

9. To remove the used Lancet from the Lancing Device, first twist off the Lancing Device Cover. While holding the Sliding Barrel, leave the Lancet Carrier and firmly stick the Lancet Needle into the Lancet Disk Cover (this will push down the Lancet Carrier). Gently remove the Lancet from the Lancet Carrier. Press the Trigger Button to release the Lancet Carrier. Replace the Lancing Device Cover.

10. To dispose of the used Lancet safely, discard it into the appropriate sharps or biohazard container. DO NOT re-uses the Lancet. If the Lancing Device is to be used by another person, provide a new Lancing Device Cover and a new Lancet.

Taking Care of your Lancing Device

Remove the Lancing Device Cover. Wash the Lancing Device Cover in warm, soapy water. Rinse well and allow it to dry thoroughly. Use alcohol or mild soap and water to wipe the remaining outside of the Lancing Device. The Lancing Device can be disinfected using 70% rubbing alcohol. (Hospitals should consult their own infection control protocols).

Limited Warranty

PALCO Labs, Inc. warrants that the Lancing Device will function effectively for a period of five (5) years from the date of purchase. A malfunctioning device should be returned to your supplier or to PALCO Labs for replacement.

Manufacture for Home Diagnostics, Inc. Fort Lauderdale, FL 33309
US Patent No. 5, 613, 978, RE 32, 922
International patents pending