ReliOn Prime Blood Glucose Test Strips Manual

IMPORTANT: Please read this insert and your ReliOnTM Prime User Instruction Manual before testing.

INTENDED USE:

ReliOn™ Prime Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. ReliOnTM Prime test strips must be used with the ReliOn™ Prime Blood Glucose Meter. Testing is done outside the body (In Vitro Diagnostic Use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for Diabetes Mellitus and is not intended for neonates.

Test Principle:
Glucose in the blood sample mixes with chemicals on the test strip. This yields a small electrical current. The ReliOnTM Prime Meter measures this current. It then shows the blood glucose result proportional to the current.

STORAGE AND HANDLING:

Store test strip containers in a cool, dry place between 3986°F (430°C).
Keep test strips away from direct sunlight and heat. Do not freeze or refrigerate.
Do not store or transfer ReliOnTM Prime Test Strips outside of the original bottle.
Do not bend, cut, or alter a ReliOnTM Prime Test Strip.
As soon as you have removed a test strip, replace the cap securely on the bottle.
When you first open the bottle, write the date on the bottle label. Use the test strips within 90 days (3 months) of first opening the bottle.
Do not use test strips beyond the expiration date on the label.
Always clean and dry your hands before handling a test strip. Do not touch the sample application tip of the test strip.
Do not use the test strip if it has been exposed to moisture. Any liquid on the test strip will cause inaccurate readings, even if the liquid is wiped off or has dried.
Do not re-use a ReliOnTM Prime Test Strip.
Only use ReliOnTM Prime Test Strips with a ReliOnTM Prime Blood Glucose Meter.

Note: Healthcare Professionals should wear gloves when testing patient blood.

TEST PROCEDURE:

Materials provided: ReliOn™ Prime Test Strips.
Materials required but not provided: ReliOnTM Prime Meter.

User Instruction Manual. Lancing Device. Sterile Lancet.

Step 1 - Wash your hands in warm, soapy water. Rinse and dry thoroughly.
Step 2 - Insert a test strip to turn the meter on. Insert a test strip contact bars first, facing up.
Step 3 - Obtain blood sample. Apply blood to the end of test strip. Capillary action will pull the blood to the reaction site. Add enough blood to the end of the test strip. The meter will begin to count down showing a flashing dash. Discard the strip if the meter does not start to count down after a blood drop is applied.

Step 4 - The meter will show a result in 7 seconds. The result will be automatically stored in memory. The meter will automatically shut off when you remove the test strip.

IMPORTANT: The minimum sample volume is 0.5 µL. Smaller samples may not start the meter or can start the meter count down and provide an “E13” error message. Ensure blood completely fills reaction site.
IMPORTANT: Read the User Instruction Manual for more information about test strips and how to test.
TEST RESULTS:
If your test result is lower than 20 mg/dL, the meter will show `LO’. If your test result is greater than 600 mg/dL, the meter will show `HI’. Seek medical assistance immediately if you obtain high or low results.

IMPORTANT: Follow all instructions fully. If you have symptoms that are not consistent with your test result, call your healthcare professional.

RANGE OF EXPECTED VALUES:
Expected blood glucose levels for people without diabetes1, 2:

Fasting	70–110 mg/dL
2 hours after meals	70–140 mg/dL

WARNINGS AND PRECAUTIONS:

For In Vitro Diagnostic Use.

IMPORTANT: Low or high blood glucose readings can indicate a potentially serious medical condition. If your blood glucose reading is unusually low or high, or you do not feel the way your readings indicate, repeat the test using a new strip. If your result is still not consistent with your symptoms, or if your blood glucose result is less than 60 mg/dL or higher than 240 mg/dL, contact your diabetes healthcare professional for advice.

Never make significant changes to your diabetes control program or ignore physical symptoms without consulting with your healthcare professional.
Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from dehydration, consult your healthcare professional immediately.

A red blood cell count (hematocrit) that is very high (above 52%) can give abnormally low results. A very low hematocrit level (below 33%) can give abnormally high results.
Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Critically ill patients should not be tested with blood glucose meters.
Patients undergoing oxygen therapy may yield false results.
Healthcare professionals — please note additional limitations of procedure:
Triglycerides up to 3,300 mg/dL do not significantly affect test results. However, glucose values in specimens beyond this triglycerides level should be interpreted with caution.
Metabolites of icodextrin (maltose, maltotriose and maltotetraose) do not significantly affect test results.

LIMITATIONS OF SYSTEM:

The ReliOnTM Prime Blood Glucose Monitoring System is not designed to substitute pathology laboratory equipment and should not be used for the diagnosis of diabetes.
Use only fresh capillary blood. Do not use serum, plasma, or venous whole blood.
Do not use the ReliOnTM Prime Blood Glucose Monitoring System to test neonates; it has not been validated for neonatal use.
ReliOnTM Prime Test Strips may be used at altitudes up to 10,000 ft (3,048 m) without effect.

IT IS RECOMMENDED TO CHECK YOUR SYSTEM USING CONTROL SOLUTION:

When you open a new bottle of test strips.
Whenever you suspect the meter or test strips may not be functioning properly.
If test results appear to be abnormally high or low or are not consistent with clinical symptoms.
If the test strip bottle has been left open or has been exposed to light, temperatures below 39°F (4°C) or
above 86°F (30°C), or humidity levels above 80%.
To check your technique.
When the ReliOnTM Prime Meter has been dropped or stored below 32°F (0°C) or above 122°F (50°C).
Each time the battery is changed.

HOW TO CHECK YOUR SYSTEM WITH CONTROL SOLUTION:
See Control Solution insert for more information.
Step 1 - Insert a test strip into the meter. Be sure the contact bars go in first and face up.
Step 2 - Press the Back or Forward button to enter control solution mode.
Step 3 - Remove the cap from the control solution bottle. Place cap on a flat surface. Squeeze the bottle and discard the first drop.
Step 4 - Apply the second drop to the top of the cap.
Step 5 - Bring the meter and strip to the drop, and allow the meter to test.
Step 6 - Compare the result to the acceptable range printed on the test strip bottle.
1 “Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia” World Health Organization, 2006
2 Diabetes Care, vol. 33 Jan:1 S82-86, 2010

If the control solution results are out-of-range, repeat the test. Results that fall outside the range may be caused by any of the following:

The meter was not placed in control solution mode before adding solution refer to manual or control solution insert.
The control solution is expired or contaminated.
The control solution was stored below 35°F (2°C) or above 86°F (30°C).
The first drop of control solution was not discarded.
The test strip was not stored correctly.
The test strip was used after the expiration date on the bottle.
The test strip bottle was open for more than 90 days (3 months).
The ReliOnTM Prime Meter has been damaged or has malfunctioned.
Contamination occurred due to the tip of the control solution bottle touching the test strip.

PLEASE NOTE:
If your Control Solution result continues to read outside the acceptable range, the system may not be working correctly. DO NOT USE the system until the control solution result is within the acceptable range. If you are unable to solve the problem, need help, or do not have control solution, please call Customer Service at 855.776.0662. Contact your diabetes healthcare professional if you cannot reach Customer Service.

REAGENT COMPOSITION:

Each ReliOnTM Prime Test Strip contains approximately:

Glucose Oxidase (Aspergillus niger sourced)	1.5-1.9 U
Hexaammineruthenium (III) Chloride	30-35 µg
Non-reactive ingredients	6-8 µg

PERFORMANCE CHARACTERISTICS FOR CONSUMERS:

ReliOn™ Prime performance has been evaluated both in laboratory and clinical tests. Diabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory method when the glucose concentration is lower than 75 mg/dL and within 20% of a laboratory method when the glucose concentration is 75 mg/dL or higher. The chart below displays how often the ReliOnTM Prime Blood Glucose Monitoring System achieves this goal. The chart is based on a study done to see how well the ReliOnTM Prime Blood Glucose Monitoring System compared to laboratory results.

Fingertip results (professional clinical)

For glucose results lower than 75 mg/dL, the percent (and number) of meter results that match the laboratory method within 15 mg/dL:	100% (12/12)
For glucose results at 75 mg/dL or higher, the percent (and number) of meter results that match the laboratory method within 20%:	99% (224/226)
Total number of participants in study (tested in duplicate) Alternate site results (professional clinical)	238 results: (119 participants) Palm
For glucose results lower than 75 mg/dL, the percent (and number) of meter results that match the laboratory method within 15 mg/dL	100% (18/18)
For glucose results at 75 mg/dL or higher, the percent (and number) of meter results that match the laboratory method within 20%	97% (212/218)
Total number of participants in study (tested in duplicate)	236 results (118 participants)

PERFORMANCE CHARACTERISTICS FOR PROFESSIONALS:

Precision:
Precision results indicate that, on average, you can expect a 2.8% variation from back-to-back testing across a 44 – 306 mg/dL glucose range. The table shows Coefficient of Variation (CV%s) values for five glucose levels that cover the glucose range typical of persons with diabetes. Values are averages from three separate lots of test strips.

Mean Glucose Level (mg/c11)	n	SD (mg/d1)	CV%
44.1	100	1.28	2.90
83.0	100	2.43	2.70
131.13	100	4.10	2.84
181.9	100	5.65	2.87
306.0	100	8.24	2.51

Accuracy:
The ReliOn™ Prime system was compared with a laboratory reference method. Testing was done both by healthcare professionals and by persons with diabetes. The correlation coefficient (r) can vary between 0 and 1, where 1 indicates perfect accuracy. The 0.99 “r” value indicates a high correlation to the reference method. This means that ReliOn™ Prime results will be very similar to results obtained on glucose analyzers used in hospital and physician office laboratories.

	Professional User
Sloe	1.1
Y-Intercept (mg/dL)	-14.4
Correlation coefficient (r)	0.99
Number of subjects	119 (238 results)
Range tested (mg/dL)	47-522 mg/dL

The ReliOn™ Prime Blood Glucose Monitoring System was tested on 119 participants in duplicate (238 values), and the results were compared to the laboratory results. The tables below show how well the two methods compared.

Glucose results lower than 75 mg/dL (<75 mg/dL)*
Range differences in values between the laboratory results and the ReliOn” Prime Blood Glucose Monitoring System	Within ± 5 mg/dL	Within ± 10 mg/dL	Within ± 15 mg/dL	Within ± 20 mg/dL
The number and percent of how many times the results fell within the ranges listed above	N = 8/12 67%	N = 12/12 100%	N = 12/12 100%	N = 12/12 100%
Glucose results greater than or equal to 75 mg/dL (>_ 75 mg/dL)*
Range differences in values between the laboratory results and the ReliOn” Prime Blood Glucose Monitoring System	Within + 5 %	Within ± 10 %	Within ± 15 %	Within ± 20%
The number and percent of how many times the results fell within the ranges listed above	N = 104/226 46%	N = 170/226 75%	N = 209/226 92%	N = 224/226 99%

* Acceptance criteria in ISO15197 are that 95% of all differences in glucose values should be within 15 mg/dL for glucose values less than 75 mg/dL (top table) and within 20% for glucose values greater than 75 mg/dL (bottom table).
Note: When glucose meter results are compared to the laboratory results, difference values below 75mg/dL are expressed in mg/dL, while those above 75 mg/dL are compared in percent.

IMPORTANT INFORMATION ABOUT ALTERNATE SITE TESTING (AST)
Sites other than your fingertip may have fewer nerve endings, so obtaining a blood sample from these sites may be less painful. The technique for alternate site testing is different from fingertip testing. Blood glucose results from sites other than your fingertip could be significantly different due to blood glucose levels changing rapidly after a meal, insulin, or exercise.
Consult your Diabetes Healthcare Professional prior to testing from a site other than your fingertips. Only palm AST is recommended. Other sites should not be used.
Results obtained from sites other than the fingertip may differ significantly as is the case with all blood glucose monitoring systems. Rapidly changing results are likely to occur after eating. Insulin dosing and physical activity are shown in the fingertip more quickly than in alternate sites.

Consider alternate site testing when:
• Testing before a meal.
• You are in a fasting state.
• Two hours have passed since a meal.
• Two hours have passed since insulin dosing.
• Two hours have passed since physical activity.

Use fingertip testing:
• Within two hours after a meal.
• Within two hours after insulin dosing.
• Within two hours after physical activity.
• If you have a history of hypoglycemia, are experiencing low blood sugar, or suffer from hypoglycemic unawareness (you cannot tell when you have low blood glucose).
• To confirm your blood glucose level if your AST result is not consistent with how you feel.
• During times of stress or illness

Ask your Diabetes Healthcare Professional about recommended testing procedures when operating machinery or driving a car, as fingertip testing is usually the preferred method of testing under these circumstances.
If bruising occurs, you may choose to lance a fingertip instead.
U.S. Patent 6,916,410 B2 is licensed by ARKRAY, Inc.

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