ReliOn Premier Blood Glucose Test Strips User Manual

ReliOn Premier Blood Glucose Test Strips User Manual

IMPORTANT

Please read this information and the meter’s user manual before using ReliOn™ Premier Test Strips. For use with ReliOn™ Premier Classic, ReliOn™ Premier Voice, ReliOn™ Premier BLU and ReliOn™ Premier Compact Blood Glucose Meters.

INTENDED USE

ReliOn™ Premier Blood Glucose Test Strips are for use with the ReliOn™ Premier Classic, ReliOn™ Premier Voice,

ReliOn™ Premier BLU and ReliOn™ Premier Compact blood glucose meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternate sites such as the forearm, palm, thigh and calf. Alternate site testing (AST) should only be used during steady-state blood glucose conditions.

ReliOn™ Premier Classic, ReliOn™ Premier Voice, ReliOn™ Premier BLU and ReliOn™ Premier Compact blood glucose monitoring systems are intended for self-testing outside the body (in vitro) by people with diabetes, at home, as an aid to monitor the effectiveness of diabetes. The system is intended to be used by a single person and should not be shared. They are not intended for use on neonates, and they are not for the diagnosis or screening of diabetes.

TEST PRINCIPLE
Glucose in blood samples react with the chemical in the test strip to produce a small electrical current. The meter detects this electrical current and measures the amount of glucose in the blood sample.

STORAGE AND HANDLING

• Store unused test strips only in their original vial.
• Store the test strip vial in a cool and dry place between 34–86˚F (1–30˚C) and 20–80% relative humidity.
• Keep the vial away from direct sunlight and heat.
• Do not freeze test strips or vial.
• Close vial cap tightly immediately after taking out a test strip.
• Avoid getting any liquid or moisture in the test strip vial. This can affect the test strips and cause inaccurate test results.
• Do not apply samples other than capillary whole blood or control solution to the test strip.
• Use the test strip immediately after taking it out of the vial.
• Handle test strips only with clean, dry hands.
• Do not bend, cut or alter the test strips in any way.
• Do not force a test strip into the meter. Gently push it into the meter’s test strip port.
• Apply only fresh capillary whole blood to the test strip.
• Use all test strips within the expiration date printed on the test strip box and vial label.
• Do not use expired test strips. Dispose of expired test strips immediately. Using test strips past their expiration dates can produce incorrect test results.
• Test strips in new, unopened vials and test strips in vials that have been opened can be used until the expiration date printed on the test strip box and vial label if the test strips are used and stored according to its storage and handling methods.

WARNINGS AND PRECAUTIONS

• Keep test strips and the test strip vial away from children. The test strips and vial cap may be choking hazards.

• Drying agents in the vial cap may be harmful if inhaled, swallowed, or may cause skin
  or eye irritation.

• Test strips are for single use only. Do not reuse.

• For over the counter use.

• The meter and lancing device are for single patient use. Do not share them with anyone including other family members. Do not use on multiple patients.

• All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

• Refer to the user manual for Cleaning and Disinfection Instructions.

• If the test strip does not absorb the blood sample properly, please contact Customer Service at 1-855- 776-0662, 7 a.m. to 7 p.m. CST, 7 days a week. At all other times, contact your healthcare professional.

BLOOD SAMPLE COLLECTION PROCEDURE
Wash hands and sample site with soap and warm water. Rinse and dry thoroughly before collecting the blood sample with a lancing device.

Fingertip Site Blood Sampling
Obtain a blood sample using a lancing device. Refer to the manufacturer’s instructions on how to use your lancing device. Allow a round drop (at least 0.5 μL) of blood to form and apply the test strip to the blood sample.

Alternate Site Testing (AST) Blood Sampling (forearm, palm, thigh, calf)
Select a clean, soft and fleshy sample site free of visible veins and hair, and away from bones. Gently massage the sample site to increase blood circulation to minimize differences between fingertip and alternate site test results. Firmly press and hold the lancing device against the sample site. Wait until the skin surface under the lancing device changes color. Then press the release button while continuing to apply pressure. Keep holding the lancing device against your skin until sufficient (at least 0.5 μL) amount of blood is drawn. Carefully lift the lancing device away from your skin.

CAUTION

• Alternate Site Testing (AST) is not available with all meters in the ReliOn Premier family. Please refer to your meter’s user manual to see if your meter is validated for alternate site testing.
• Alternate site and fingertip results may differ significantly due to rapid changes in the glucose level after meals or exercise, hypoglycemic symptoms, or effects of drugs such as insulin. Use a fingertip sample if you suffer from hypoglycemia, or have experienced hypoglycemic shock or symptoms.
• AST results should never be used to calibrate Continuous Glucose Monitoring Systems nor entered into an insulin dosing calculator or pump for dosing recommendations.
• For instructions on how to obtain samples from alternate sites, please refer to the AST section of the meter’s user manual.

TEST PROCEDURE

1. Wash hands and sample site with soap and warm water. Rinse and dry thoroughly.
2. Insert the test strip into the meter’s test strip port with the contact bars facing up. Push the test strip gently into the strip port until the power automatically turns on.
3. The apply blood sample symbol will appear.
4. Use a lancing device to get a blood sample. The sample must be at least 0.5 μL to fill the test strip confirmation window. When the apply blood sample symbol appears on the display, apply the blood sample to the edge of the narrow end of the test strip until the meter beeps. If the confirmation window is not filled completely, an ‘Er4’ message may appear.
5. The meter will count down to 1 on the display. The test result, time and date will appear, and automatically store in the meter memory. Remove the used test strip from the test strip port. The meter will turn off after 3 seconds.

TEST RESULTS

The ReliOn™ Premier family of blood glucose meters will display results between 20 and 600 mg/dL.

Normal Blood Glucose Results
Normal blood glucose levels for an adult without diabetes are below 100 mg/dL before meals and fasting and are less than 140 mg/dL two hours after meals.1
Fasting is defined as no caloric intake for at least eight hours.

Severely Low Blood Glucose Results
If the test result is below 20 mg/dL, ‘Lo’ will appear on the display, showing severe hypoglycemia (very low blood glucose levels). Wash and dry your hands thoroughly, then repeat the test with a new test strip. If the result repeats, contact your healthcare professional immediately for advice and treatment.

Severely High Blood Glucose Results
If the test result is above 600 mg/dL, ‘HI’ will appear on the display, showing severe hyperglycemia (much higher than normal blood glucose levels). Wash and dry your hands thoroughly, then repeat the test with a new test strip. If the result repeats, contact your healthcare professional immediately for advice and treatment.

Unexpected Results
Low or high blood glucose readings can indicate a potentially serious medical condition. If your results are unusually high or low, or do not match the way you feel, repeat the test with a new test strip. If your reading is inconsistent with your symptoms, or your result is less than 60 mg/dL or higher than 240 mg/dL, contact your healthcare professional.

CAUTION: To reduce the chance of infection

• All components that come into contact with blood samples are considered biohazardous and capable of transmitting viral diseases, even after disinfection.
• Do not use a lancet that has been used by others, and never share your meter and lancing device with another person.
• Wash your hands thoroughly with soap and water after handling the meter, lancing device or test strips.
• Keep your meter and lancing device clean.
• To minimize the risk of transmission of bloodborne pathogens, pre-cleaning and disinfection procedure should be performed as recommended in the user manual for your meter (see “Cleaning and Disinfection” section).
• You can get more safety information at FDA Public Health Notification (http://wayback.archive-it. org/7993/20170111013014/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm) or at CDC Clinical Reminder (http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html).

LIMITATIONS

• An abnormally high or low red blood cell count may produce inaccurate results. Please refer to your meter’s user manual for the hematocrit range specification.

• Inaccurate results may occur in severely hypotensive individuals or patients in shock.
  Inaccurate low results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis.

• Severe dehydration (excessive water loss) may cause false low results. If you believe you are suffering from severe dehydration, consult your healthcare professional immediately.

• Altitudes of higher than 10,000 ft. (3,048 m) above sea level may have an effect on the performance of the test strip.

• The single-patient use system is for single-patient use only and should not be shared.

• Not for neonatal use.

• Not for use on critically ill patients.

• Not for use in anyone undergoing oxygen therapy.

• For in vitro diagnostic use only.

• Do not use for the diagnosis of or screening of diabetes mellitus.

METER AND TEST STRIP PERFORMANCE CHECK

The ReliOn™ Premier Control Solutions (Level 1 and 2) contain fixed amounts of glucose
and are used for checking whether the test strips and the meter are working together properly. Use ReliOn™ Premier Control Solution when:

• You want to practice the test procedure, instead of using blood.
• You use your meter for the first time.
• You begin using a new vial of test strips.
• You suspect that the meter or test strips are not working properly.
• You think your test results are inaccurate or they do not reflect how you feel.
• You use your meter for blood glucose testing after any disinfection procedure.
• The meter has been dropped or damaged.

The test result of each control solution should be within the range printed on the strip vial.
If your control solution test results do not fall within the range printed on the test strip vial, repeat the test.

Out of range results may be due to one or more of the following factors:

• Error in performing the test.
• Expired or contaminated control solution.
• Expired or damaged test strip.
• Failure to shake the control solution bottle.
• Failure to discard the first one or two drops of control solution and wipe the bottle tip clean.

If results continue to fall outside the range printed on the vial, the test strips and meter may not be working properly. If so, do NOT use your system and contact Customer Service: 1-855-776-0662, 7a.m.–7p.m. Central time, 7 days a week. At all other times, contact your healthcare professional.

CHEMICAL COMPOSITION

Each ReliOn™ Premier Blood Glucose Test Strip contains the following reagents:

• Glucose oxidase (Aspergillus sp.): 2.7 units
• Hexaammineruthenium(III) chloride: 45.7 μg
• Other ingredients: 1.6 μg

PERFORMANCE CHARACTERISTICS

The performance of the ReliOn™ Premier Blood Glucose Test Strips has been evaluated in laboratory and clinical tests.

Measurement Range
The measurement range of the ReliOn™ Premier family of blood glucose monitoring systems is
20 to 600 mg/dL.

Accuracy
The ReliOn™ Premier Blood Glucose Monitoring System is calibrated to yield results equivalent to plasma glucose concentrations. For the performance data of your specific meter, please refer to your meter’s user manual. The model number can be found on the back of your meter. The accuracy of the system was assessed by comparing blood glucose results obtained by patients with those obtained using a YSI Model 2300

Glucose Analyzer, a lab instrument. The results below were obtained by diabetic patients at clinic centers.

This study shows that the system compares well with a laboratory method.

Precision

This study shows that there could be variation of up to 4.1%.

Alternate Site Testing Evaluation

Comparison of various AST with respect to the results of YSI measurements:

• Alternate site test results for glucose concentration < 75 mg/dL

• Alternate site test results for glucose concentration ≥ 75 mg/dL

• Alternate Site Testing (AST) is not available with all meters in the ReliOn™ Premier family. Please refer to your meter’s user manual to see if your meter is validated for alternate site testing.

Reference
1. American Diabetes Association. Standards of Medical Care in Diabetes – 2018. Diabetes Care. January 2018; 41(1): S13-S27.

• No part of this document may be reproduced in any form or by any means without the prior written consent of the manufacturer.
• The information in this manual is correct at the time of printing. However, the manufacturer reserves the right to make any necessary changes at any time without notice as our policy is one of continuous improvement.

Customer Service
1-855-776-0662
7a.m.–7p.m. Central time, 7 days a week

In case of emergency, please contact your healthcare professional or emergency medical response.

Distributed By:
Wal-Mart Stores, Inc.
Bentonville, AR 72716
www.ReliOnBGM.com

© 2019 All Rights Reserved.
P/N 5414-04 Rev. 01/20
PGK7E1202 Rev4 01/2020

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References

• CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens | Injection Safety | CDC
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