How To Use Relion Premier Classic

ReliOn Premier Blood Glucose Test Strips User Manual

Of import

Delight read this data and the meter's user manual earlier using ReliOn™ Premier Test Strips. For utilise with ReliOn™ Premier Archetype, ReliOn™ Premier Voice, ReliOn™ Premier BLU and ReliOn™ Premier Meaty Blood Glucose Meters.

INTENDED Use

ReliOn™ Premier Blood Glucose Test Strips are for utilise with the ReliOn™ Premier Archetype, ReliOn™ Premier Voice,

ReliOn™ Premier BLU and ReliOn™ Premier Compact blood glucose meters to quantitatively measure glucose in fresh capillary whole claret samples fatigued from the fingertips and alternate sites such as the forearm, palm, thigh and dogie. 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 exterior the body (in vitro) by people with diabetes, at home, as an help to monitor the effectiveness of diabetes. The arrangement is intended to be used past a single person and should not exist shared. They are non intended for use on neonates, and they are not for the diagnosis or screening of diabetes.

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

STORAGE AND Treatment

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–thirty˚C) and xx–eighty% relative humidity.
Go on the vial abroad from direct sunlight and estrus.
Do non freeze test strips or vial.
Close vial cap tightly immediately later on taking out a test strip.
Avert getting whatever liquid or wet in the test strip vial. This can affect the test strips and cause inaccurate examination results.
Do not utilise samples other than capillary whole claret 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 out hands.
Do non bend, cut or alter the exam strips in any mode.
Do not force a test strip into the meter. Gently push it into the meter's test strip port.
Employ 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.
Exam strips in new, unopened vials and exam strips in vials that have been opened can be used until the expiration engagement printed on the test strip box and vial label if the exam strips are used and stored according to its storage and handling methods.

WARNINGS AND PRECAUTIONS

Proceed test strips and the test strip vial away from children. The test strips and vial cap may exist choking hazards.
Drying agents in the vial cap may be harmful if inhaled, swallowed, or may cause pare
or heart irritation.
Examination strips are for single use just. Do not reuse.
For over the counter use.
The meter and lancing device are for single patient use. Practice not share them with anyone including other family unit members. Do non use on multiple patients.
All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, fifty-fifty afterward you have performed cleaning and disinfection.
Refer to the user transmission for Cleaning and Disinfection Instructions.
If the test strip does not absorb the blood sample properly, delight contact Client Service at 1-855- 776-0662, seven a.m. to 7 p.m. CST, 7 days a calendar week. At all other times, contact your healthcare professional person.

Claret SAMPLE COLLECTION Procedure
Wash hands and sample site with lather and warm h2o. Rinse and dry thoroughly before collecting the claret sample with a lancing device.

Fingertip Site Blood Sampling
Obtain a claret sample using a lancing device. Refer to the manufacturer'due south instructions on how to apply your lancing device. Let a round drop (at least 0.5 μL) of blood to form and apply the test strip to the blood sample.

Alternating Site Testing (AST) Blood Sampling (forearm, palm, thigh, calf)
Select a make clean, soft and fleshy sample site gratis of visible veins and hair, and abroad from bones. Gently massage the sample site to increase claret circulation to minimize differences between fingertip and alternate site examination results. Firmly press and concord the lancing device against the sample site. Wait until the skin surface under the lancing device changes color. Then press the release push button while continuing to apply pressure. Go on holding the lancing device against your pare until sufficient (at to the lowest degree 0.5 μL) amount of claret is drawn. Carefully lift the lancing device away from your peel.

Caution

Alternate Site Testing (AST) is not available with all meters in the ReliOn Premier family. Delight refer to your meter's user transmission 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. Utilize a fingertip sample if you endure 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 estimator or pump for dosing recommendations.
For instructions on how to obtain samples from alternate sites, delight refer to the AST section of the meter's user manual.

TEST Process

Wash easily and sample site with soap and warm water. Rinse and dry thoroughly.
Insert the test strip into the meter's examination strip port with the contact confined facing upwardly. Button the test strip gently into the strip port until the ability automatically turns on.
The apply claret sample symbol will appear.
Use a lancing device to get a blood sample. The sample must be at least 0.five μL to fill the examination strip confirmation window. When the utilise blood sample symbol appears on the brandish, apply the claret sample to the edge of the narrow finish of the exam strip until the meter beeps. If the confirmation window is not filled completely, an 'Er4' message may appear.
The meter volition 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 plough off after 3 seconds.

TEST RESULTS

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

Normal Blood Glucose Results
Normal claret 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 divers as no caloric intake for at least eight hours.

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

Severely Loftier Blood Glucose Results
If the test result is above 600 mg/dL, 'Howdy' 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 exam strip. If the result repeats, contact your healthcare professional person immediately for advice and treatment.

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

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, fifty-fifty subsequently disinfection.
Do non utilize a lancet that has been used past others, and never share your meter and lancing device with another person.
Wash your hands thoroughly with soap and h2o after handling the meter, lancing device or examination strips.
Go along your meter and lancing device clean.
To minimize the risk of manual of bloodborne pathogens, pre-cleaning and disinfection procedure should exist performed as recommended in the user manual for your meter (see "Cleaning and Disinfection" department).
You can get more than prophylactic information at FDA Public Health Notification (http://wayback.archive-information technology. 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. Delight refer to your meter'due south user manual for the hematocrit range specification.
Inaccurate results may occur in severely hypotensive individuals or patients in shock.
Inaccurate depression results may occur for individuals experiencing a hypoglycemic hyperosmolar state, with or without ketosis.
Severe dehydration (excessive h2o loss) may cause imitation depression results. If you believe you lot are suffering from astringent dehydration, consult your healthcare professional immediately.
Altitudes of higher than x,000 ft. (iii,048 m) in a higher place bounding main level may accept an consequence on the functioning of the test strip.
The unmarried-patient use organization is for single-patient utilise but and should not be shared.
Non for neonatal apply.
Not for use on critically ill patients.
Not for use in anyone undergoing oxygen therapy.
For in vitro diagnostic apply only.
Do not use for the diagnosis of or screening of diabetes mellitus.

METER AND Test STRIP Performance Cheque

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 exercise the test process, instead of using blood.
You apply your meter for the first time.
You begin using a new vial of test strips.
You doubtable that the meter or exam strips are not working properly.
You think your examination results are inaccurate or they do not reverberate how you feel.
You lot utilize your meter for blood glucose testing after whatever disinfection process.
The meter has been dropped or damaged.

The examination result of each command solution should exist within the range printed on the strip vial.
If your command solution test results practice not fall within the range printed on the test strip vial, repeat the exam.

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

Error in performing the examination.
Expired or contaminated control solution.
Expired or damaged examination strip.
Failure to shake the control solution canteen.
Failure to discard the first 1 or two drops of command solution and wipe the canteen tip make clean.

If results continue to autumn exterior the range printed on the vial, the test strips and meter may not exist working properly. If so, practice Not use your arrangement and contact Customer Service: 1-855-776-0662, 7a.m.–7p.m. Central fourth dimension, 7 days a calendar week. At all other times, contact your healthcare professional.

CHEMICAL Composition

Each ReliOn™ Premier Blood Glucose Test Strip contains the post-obit reagents:

Glucose oxidase (Aspergillus sp.): 2.7 units
Hexaammineruthenium(Three) chloride: 45.seven μg
Other ingredients: ane.6 μg

PERFORMANCE CHARACTERISTICS

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

Measurement Range
The measurement range of the ReliOn™ Premier family of claret 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'southward 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 past patients with those obtained using a YSI Model 2300

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

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

Precision

This study shows that in that location could exist variation of upwardly to 4.1%.

Alternate Site Testing Evaluation

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

Alternate site exam results for glucose concentration < 75 mg/dL

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

Alternating Site Testing (AST) is non bachelor with all meters in the ReliOn™ Premier family. Please refer to your meter's user manual to encounter if your meter is validated for alternate site testing.

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

No part of this document may be reproduced in any course or by whatever ways without the prior written consent of the manufacturer.
The information in this transmission is right at the time of printing. However, the manufacturer reserves the right to make any necessary changes at whatever fourth dimension without notice equally our policy is one of continuous comeback.

Customer Service
ane-855-776-0662
7a.1000.–7p.thousand. Primal time, seven 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

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