How To Clear Data On Relion Voice Glucose Meter

ReliOn Premier Blood Glucose Exam Strips User Manual

Important

Please read this information and the meter's user transmission earlier using ReliOn™ Premier Test Strips. For use with ReliOn™ Premier Classic, ReliOn™ Premier Voice, ReliOn™ Premier BLU and ReliOn™ Premier Compact Claret Glucose Meters.

INTENDED USE

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

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

ReliOn™ Premier Classic, ReliOn™ Premier Voice, ReliOn™ Premier BLU and ReliOn™ Premier Compact blood glucose monitoring systems are intended for cocky-testing outside the body (in vitro) by people with diabetes, at home, as an aid to monitor the effectiveness of diabetes. The organisation is intended to be used by a unmarried person and should not exist 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 chemic in the exam 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 exam strip vial in a cool and dry place between 34–86˚F (1–30˚C) and 20–80% relative humidity.
Keep the vial abroad from direct sunlight and heat.
Do not freeze examination strips or vial.
Shut vial cap tightly immediately afterward taking out a exam strip.
Avoid getting whatsoever liquid or wet in the exam strip vial. This tin bear upon the exam strips and crusade inaccurate test results.
Exercise not apply samples other than capillary whole blood or control solution to the test strip.
Use the examination strip immediately after taking it out of the vial.
Handle test strips only with clean, dry hands.
Do not bend, cut or change the test strips in whatever mode.
Practise non forcefulness a examination strip into the meter. Gently push it into the meter's test strip port.
Apply only fresh capillary whole blood to the exam strip.
Use all test strips within the expiration date printed on the examination strip box and vial label.
Do not use expired test strips. Dispose of expired test strips immediately. Using exam strips past their expiration dates can produce incorrect test results.
Examination strips in new, unopened vials and test strips in vials that accept been opened tin can be used until the expiration date printed on the exam 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 exam strips and vial cap may be choking hazards.
Drying agents in the vial cap may be harmful if inhaled, swallowed, or may cause peel
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 unmarried patient employ. Practise not share them with anyone including other family members. Exercise not apply on multiple patients.
All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, fifty-fifty after you lot have performed cleaning and disinfection.
Refer to the user manual for Cleaning and Disinfection Instructions.
If the exam strip does not blot the blood sample properly, delight contact Customer Service at 1-855- 776-0662, vii a.m. to vii p.chiliad. CST, 7 days a week. At all other times, contact your healthcare professional.

Claret SAMPLE Collection PROCEDURE
Wash easily and sample site with soap and warm water. Rinse and dry out 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'south instructions on how to use your lancing device. Let a circular drop (at to the lowest degree 0.5 μL) of blood to form and use the exam 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 increment claret circulation to minimize differences between fingertip and alternating site examination results. Firmly press and hold the lancing device against the sample site. Wait until the skin surface nether the lancing device changes colour. And so press the release button while continuing to apply pressure. Keep property the lancing device against your skin until sufficient (at least 0.5 μL) amount of claret is drawn. Carefully lift the lancing device abroad from your peel.

CAUTION

Alternating 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 alternating site testing.
Alternate site and fingertip results may differ significantly due to rapid changes in the glucose level afterwards meals or exercise, hypoglycemic symptoms, or effects of drugs such as insulin. Use a fingertip sample if y'all suffer from hypoglycemia, or have experienced hypoglycemic stupor 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, delight refer to the AST department of the meter's user manual.

TEST PROCEDURE

Wash hands and sample site with soap and warm h2o. Rinse and dry thoroughly.
Insert the test strip into the meter'southward examination strip port with the contact bars facing upward. Push the exam strip gently into the strip port until the ability automatically turns on.
The apply blood sample symbol will appear.
Apply a lancing device to get a claret sample. The sample must be at least 0.5 μL to make full the exam strip confirmation window. When the utilize blood sample symbol appears on the brandish, apply the claret sample to the edge of the narrow terminate of the examination strip until the meter beeps. If the confirmation window is not filled completely, an 'Er4' message may appear.
The meter will count downwardly to 1 on the display. The test result, fourth dimension and date will announced, and automatically shop in the meter memory. Remove the used test strip from the test strip port. The meter will turn off after iii seconds.

Examination RESULTS

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

Normal Claret Glucose Results
Normal blood glucose levels for an developed without diabetes are beneath 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 Claret Glucose Results
If the test result is below twenty mg/dL, 'Lo' will appear on the display, showing astringent hypoglycemia (very depression blood glucose levels). Wash and dry your hands thoroughly, and then repeat the exam with a new test strip. If the consequence repeats, contact your healthcare professional immediately for advice and treatment.

Severely High Blood Glucose Results
If the test upshot is to a higher place 600 mg/dL, 'HI' will appear on the display, showing severe hyperglycemia (much higher than normal claret glucose levels). Launder 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 communication and handling.

Unexpected Results
Depression or high blood glucose readings can signal a potentially serious medical status. If your results are unusually high or depression, or exercise not match the way y'all feel, echo 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 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 after disinfection.
Practice non employ 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 later treatment the meter, lancing device or examination strips.
Continue your meter and lancing device clean.
To minimize the hazard of manual of bloodborne pathogens, pre-cleaning and disinfection process should be performed as recommended in the user manual for your meter (come across "Cleaning and Disinfection" section).
You can get more condom data 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 blood-red claret 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.
Astringent dehydration (excessive water loss) may cause false low results. If yous believe you lot are suffering from astringent dehydration, consult your healthcare professional person immediately.
Altitudes of college than 10,000 ft. (three,048 one thousand) above body of water level may have an effect on the performance of the test strip.
The single-patient employ organisation is for unmarried-patient use merely and should not exist shared.
Not for neonatal utilize.
Not for apply on critically ill patients.
Not for employ in anyone undergoing oxygen therapy.
For in vitro diagnostic utilize only.
Practise not utilise for the diagnosis of or screening of diabetes mellitus.

METER AND TEST STRIP Performance Check

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

You lot want to practise the examination procedure, instead of using blood.
You lot use your meter for the kickoff time.
You begin using a new vial of exam strips.
You doubtable that the meter or test strips are not working properly.
You recollect your exam results are inaccurate or they do not reflect how you feel.
You utilise your meter for blood glucose testing subsequently any disinfection procedure.
The meter has been dropped or damaged.

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

Out of range results may be due to i 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 command 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 exterior the range printed on the vial, the examination strips and meter may non be working properly. If so, practice Not utilize your organisation and contact Client Service: 1-855-776-0662, 7a.yard.–7p.k. Cardinal time, 7 days a calendar 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.vii units
Hexaammineruthenium(Three) chloride: 45.7 μg
Other ingredients: ane.6 μg

Operation CHARACTERISTICS

The performance of the ReliOn™ Premier Claret Glucose Exam 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 Organisation 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 dorsum of your meter. The accuracy of the organisation 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 arrangement compares well with a laboratory method.

Precision

This study shows that there could be variation of up to iv.1%.

Alternating Site Testing Evaluation

Comparison 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 available with all meters in the ReliOn™ Premier family. Please refer to your meter's user manual to run into if your meter is validated for alternate site testing.

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

No role of this document may be reproduced in any form or past any ways without the prior written consent of the manufacturer.
The information in this manual is correct at the time of printing. Nevertheless, the manufacturer reserves the correct to make any necessary changes at whatever time without discover as our policy is one of continuous improvement.

Client Service
1-855-776-0662
7a.yard.–7p.m. Central fourth dimension, 7 days a week

In instance of emergency, delight contact your healthcare professional or emergency medical response.

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

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