PrestigeIQ Glucose Kit (meter,10 strips,supplies) The Prestige IQ blood glucose monitor is an unmatched combination of accuracy, ease, and affordability, the Prestige IQ a large easy-to-read display and utilizes Smart System test strips costing 40% less than competive brands

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Blood Glucose Test Strips Instructions

Intended Use: The Prestige Smart System™ Family of Products (Meters, Test Strips, and Glucose Controls) is intended for both professional and self-testing of glucose in human whole blood. Testing blood glucose regularly can help keep diabetes under control. Diabetes should be managed under the guidance of a Doctor or Diabetes Healthcare Professional.

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 or Control solution. The Prestige Smart System™ Meter measures the color and displays glucose results.

Important parts of the Test Strip:

1. Test Spot: This "circle" is where blood or Control solution is applied.
2. Color Spot: Color Spot changes color when the Strip reacts with the glucose in blood or Control solution.

Precautions: Use Prestige Smart System™ Test Strips for in vitro (external) use only. DO NOT CONSUME.

Do not use Color Spot alone (without the Meter) to measure glucose. This is not a visual test.

Before running a test, allow Meter, Test Strips and Control solution to reach room temperature.

NEVER transfer Test Strips from one vial to another; store Test Strips ONLY in their original vial.

How to Perform a Blood Glucose Test: Read your Owner's Booklet for complete testing details.

1. Gather Supplies. Meter, Test Strips, Lancing Device, Lancet, Facial Tissue
2. Turn the Meter on. Match the Code printed on the Test Strip Vial Label with the Code displayed in the Meter. Change Meter Code if needed (see Owner's Booklet).
3. Remove one Test Strip from the vial. Replace cap.
4. Obtain blood. One drop of fresh capillary whole blood lanced from a clean, dry finger is the preferred sample. See Lancing Device instructions for Use. Venous whole blood drawn by a Healthcare Professional may also be used to perform a test. Please read "Clinical Testing with the Prestige Smart System" for instructions on blood collection and preparation using venous blood. NEVER use serum, plasma or clotted blood.
5. Apply blood. Apply blood to the Test Spot of the Test Strip, allowing the Test Spot to absorb the blood. Do not allow finger to touch the Test Spot.
6. Check Color Spot. After applying blood to the Test Spot, turn the Test Strip over. Check the Color Spot 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 with a new Test Strip.
7. Insert Test Strip. Turn Test Strip over so Test Spot is facing up. Point arrow printed on Test Strip towards the Meter and insert the Test Strip into the Meter Test Strip Platform.
8. Record the result in your Self-Test Log Book.
9. Turn the Meter off. Discard Test Strip. Pull the Test Strip from the Meter and discard in appropriate container.

Expected Results: Expected whole blood glucose results for people without diabetes.1

If you are not a known diabetic and your whole blood glucose result remains below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L)2, CONTACT YOUR DOCTOR.

Unusual Test Results: You may get a test result that seems too high or too low or does not agree with the way you feel. If this happens, please check your Meter, Test Strips and testing technique. Follow the Troubleshooting Tips below.

1. Repeat the test using a new Test Strip. After applying blood the Test Spot, turn the Test Strip over. Check the Color Spot 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. Too little or too much blood can give false glucose readings.
2. Check the expiration date on the Test Strip Vial label. If the expiration date has passed, throw the vial away and use a new vial of Test Strips.
3. Check for discoloration of the Color Spot on an unused Test Strip. The Test Strips may be damaged. Damage may occur if the vial was not tightly recapped, or if the Strips were stored in extreme heat or cold. Replace the Strips as needed.
4. Match the Code printed on the Test Strip Vial Label with the Meter Code. Change the Meter Code if needed. Follow the steps described in your Owner's Booklet.
5. Clean the Meter. Read Section 7 of the Owner's Booklet and follow all the steps listed.
6. Perform QC testing (see below).

If results seem too high or low, repeat the test with a new Test Strip. Always consult with your Doctor or Diabetes Healthcare Professional before changing your treatment program.

Quality Control (QC) Testing (using Control Solution 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™ Control solution is used to check testing technique and System performance. Two levels of Control solution (low and high) are available. When Control results fall within the Control Range printed on the Test Strip Vial Label in use, the System is working as it should, and your testing technique is good. The Control Range can be found on the Test Strip box and on the Test Strip vial label. 1-indicates low range 2-indicates high range. Read the Owner's Booklet or Glucose Control Instructions for Use for complete testing details.

The Prestige Smart System™ Standard Strip is a hard plastic strip supplied with each Meter. The Standard Strip does not have a lot number or an expiration date. When Standard Strip results fall within the range of numbers printed on the Standard Strip label, the Meter is working as it should. Read the Owner's Booklet for complete testing details.

Storing Test Strips: Test Strips must be kept in their original, capped, labeled vial. Contact with moisture may cause false results. After removing a Test Strip from the vial, immediately recap the vial.

Store Test Strips at a temperature less than 86°F (30°). DO NOT FREEZE.

IMPORTANT: Bring Test Strip vial to room temperature before opening and using Test Strips.

DO NOT store in a bathroom or kitchen. DO NOT expose Test Strips to extreme heat or cold, direct sunlight, or humidity.

Limitations: The Prestige Smart System™ should not be used to test newborn (neonatal) blood samples.

The following WILL affect results:

1. Blood preserved with fluoride anticoagulant3
2. Medications containing L-dopa3

The following MAY affect results:

1. Hyperglycemia with hyperosmolarity, with or without ketosis. 
2. Thickened blood caused by dehydration

NOTE: Similar observations have been reported by other blood glucose testing systems.4,5

The following WILL NOT affect results:

1. Hematocrit levels between 30 and 55 percent3 
2. Elevated total blood cholesterol and triglycerides3
3. Reducing substances such as uric and ascorbic acid when occurring in expected blood concentrations4
4. Treatment of blood with EDTA or Heparin3
5. Acetaminophen, salicylate, ibuprofen and ketoprofen occurring in expected blood concentrations4
6. Testing at altitudes up to and including 7,000 feet3

Test Principle. The Prestige Smart System™ measures whole blood glucose by using membrane technology that employs the glucose oxidase/peroxidase reaction.

When whole blood is applied to a Test Strip, the glucose in the plasma (liquid part of the blood) is absorbed into the Color Spot and reacts with chemicals that break down the glucose. The amount of glucose in the blood changes the color of the Color Spot. The Meter reads the color and displays the glucose value.

Chemical Composition:

Clinical Testing with the Prestige Smart System™ (For Healthcare Professionals Only): The Prestige Smart System™ is optimized for testing with fresh capillary whole blood. When results obtained from the Prestige Smart System™ are compared to results performed with a lab system, it is advised to use fresh blood from a clean, dry finger for both the Prestige Smart System™ and lab System. For best results, glucose tests should be performed within ten minutes after sampling from the finger because blood glucose levels decrease over time.

If various blood is used, it is advised that samples be drawn into tubes that contain either EDTA (purple top tube) or Heparin (green top tube). Each tube of whole blood should be mixed gently just prior to testing. DO NOT USE BLOOD SAMPLES THAT HAVE BEEN PRESERVED WITH FLUORIDE. DO NOT USE PLASMA, SERUM OR CLOTTED BLOOD. Avoid testing samples that were drawn more than ten minutes prior to testing. Always run Prestige Smart System™ blood glucose tests and lab tests at the same time.

NOTE: Even when tests are performed within ten minutes after sampling and per manufacturers' instructions, there may be a large difference between capillary whole blood results tested using the Prestige Smart System™ and venous whole blood tested using a lab system.6,7

Performance Characteristics:4

ACCURACY: Whole blood glucose test results were compared using the Prestige System and the Yellow Springs Instrument Model 23A, which also uses a glucose oxidase method. The study shows that the Prestige Smart System™ compares well with a laboratory system. A regression analysis of the 200 tests performed is given below:

PRECISION: A whole blood precision study was performed in a lab using the Prestige Smart System™ . This study shows a Strip-to-Strip variation of less than or equal to 5.2%.

Results are shown below:

CONSUMER STUDY:  The Prestige Smart System™ was tested at a diabetes clinic of a large urban area hospital and a diabetes care center of a medical center. Prestige results were obtained from 106 patients and were compared to parallel results obtained on Yellow Springs Instruments Model 23A7 or Model 15008. This study shows that patients, when self-testing, are able to obtain accurate results when compared to professional test results using a lab System.

References:

1. American Diabetes Association Clinical Practice Recommendation, Diabetes Care, 23 (Suppl. 1): 532-560, 2000.
2. Badger, R. S., Hill, J.V.C.: The Joslin Guide to Diabetes, New York, NY:  FIRESIDE (1995). 148 - 161.
3. Data on file.
4. Hacket J. Aziz, K., "Review Criteria Assessment of Portable Blood Glucose Monitoring in Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology," FDA Draft Document, p.6. (1997).
5. Young D.S.: Effects on Drugs of Clinical Laboratory Test, Third Edition. Washington, D.C.:AACC Press (1990), pp.3-168, 3-180.
6. Caraway, W.I "Carbohydrates" in Fundamentals of Clinical Chemistry, Tietz NW, ED., Philadelphia, PA, Saunders, 1976. pp 242-243.
7. Yellow Springs Instrument Model 23A and 23AM Glucose Analyzer Instruction Manual, "Principles of Operation", pp. 1-2 and "Performance Specifications', p.3, 1986.
8. YSI 1500 Sidekick Glucose Operations Manual, "Principles of Operation", pp. 4-1-4-3, "Specifications", pp. 1 -2.

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