Relion GM505VAA User Manual

™

Blood Glucose Monitoring System

User Manual

INDEX

01 - Important Information: Read this First ................... 2

02 - ReliOn™ Premier Compact Blood Glucose

Monitoring System ................................................... 3

03 - ReliOn™ Premier Blood Glucose Test Strip ............ 4

04 - ReliOn™ Premier Compact

Blood Glucose Meter ................................................ 5

05 - Checking the System ................................................ 6

06 - Using the Lancing Device ........................................ 8

07 - Testing Your Blood Glucose Level ......................... 10

08 - Alternate Site Testing .............................................12

09 - ‘HI’ and ‘Lo’ Messages .............................................14

10 - Viewing Test Results in Meter Memory ................ 15

11 - Understanding Error Messages.............................15

12 - Caring for the ReliOn™ Premier

Compact System ......................................................16

13 - Replacing the Battery ............................................. 19

14 - Performance Characteristics .................................20

15 - Warranty Information ............................................. 22

ReliOn™ Premier Compact Blood Glucose Monitoring System is
waived under CLIA.

• An abnormally high or low red blood cell count (hematocrit level
over 60% or below 20%) may produce inaccurate 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.

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

• For questions or concerns, contact Customer Service:
1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.
At all other times or in case of emergency, contact your
healthcare professional or emergency medical response.

02 - ReliOn™ Premier Compact Blood

Glucose Monitoring System

ReliOn™ Premier Compact Components

Verify that all these components are included in the system box.

• ReliOn™ Premier Compact Blood Glucose Meter

• ReliOn™ Premier Blood Glucose Test Strips (50)

• User Manual / Quick Reference Guide

• Test Strip Insert • Carry Case

• Logbook • Lancing Device

• Battery (1) • Lancets (10)

• Check all the components after opening the ReliOn™ Premier
Compact Blood Glucose Monitoring System package.

• ReliOn™ Premier Control Solutions are necessary but
not included.

• ReliOn™ Premier Control Solutions can be ordered separately
by contacting Customer Service: 1-855-776-0662, 7 a.m. to
7 p.m. Central time, 7 days a week. At all other times, contact
your healthcare professional.

Specications

• Model: GM505VAA

• Measurement range: 20–600 mg/dL

• Sample size: Minimum 0.5 µL

• Test time: 5 seconds

• Sample type: Fresh capillary whole blood

• Calibration: Plasma-equivalent

• Battery life: 1,000 tests

• Assay method: Electrochemical

• Power: One 3.0 V lithium battery (type CR2032)

NOTE

• You can get more safety information at CDC Clinical
Reminder (http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html).

04 - ReliOn™ Premier Compact Blood

Glucose Meter

Display

Shows results,
messages

Test Strip Port

Insert test strip here

ReliOn™ Premier Compact Blood Glucose
Meter Display

Test results:

test results are displayed here

Blood insertion symbol:

indicates meter is
ready for the application
of a drop of blood or
control solution

Battery symbol:

is running low and needs to be
replaced

NOTE

• The unit of measurement for your ReliOn™ Premier
Compact Meter is preset and xed in mg/dL.

Turns the meter on/o

and checks the memory

mg/dL:

unit of measure
for blood glucose
tests

indicates meter battery

Button

Control Solution Testing

Step 1

Insert a test strip into the meter’s test
strip port, with the contact bars facing
upwards until the meter beeps. Be careful
not to bend the strip while pushing it in.
The symbol will appear on the display.

Step 2

Shake the ReliOn™ Premier Control
Solution bottle before each test. Remove
the cap and squeeze the bottle to discard
the rst 1 or 2 drops. Then wipe the
tip with a clean tissue or cloth. After
the symbol appears on the display,
apply the solution to the narrow edge
of the test strip until the meter beeps.
Make sure the conrmation window
lls completely.

NOTE

• The meter will switch o if the control solution sample is not
applied within 2 minutes of the symbol appearing on the
screen.

• If the meter turns o, remove the strip, reinsert it. Then start
from step 1.

Step 3

A test result will appear after the meter counts down
from 5 to 1.

Step 4

–
–

CAUTION

• The ranges printed on the test strip vial are for ReliOn™
Premier Control Solutions only. They do not have any
connection to your blood glucose level.

Compare the result displayed on the
meter to the range printed on the test strip
vial. The result should fall within that range.
Used test strips should be discarded safely
in disposable containers.

Charger

AST Cap

• The lancing device is for use by a single user only and should not
be shared with anyone including other family members.

CAUTION
To reduce the chance of infection

• All components that come into contact with blood samples
should be considered biohazardous and capable of transmitting
viral diseases, even after disinfection.

• Do not use a lancet that has been used by another person and
never share your meter and lancing device with anyone.

• Wash your hands thoroughly with soap and water after handling
your meter, lancing device and test strips.

• Keep your meter and lancing device clean. See the pre-cleaning
and disinfection section on page 16.

NOTE

• Repeated puncturing at the same sample site may cause pain
or skin calluses (thick, hard skin).

• Choose a dierent site each time you test.

Cap

Lancet Holder

Lancet

Release Button

Preparing the Lancing Device

Step 1

Wash hands and the sample site with soap
and warm water. Rinse and dry thoroughly.

Step 2

Pinch and pull the cap to remove.

Step 3

Insert a new disposable lancet rmly into
the lancet holder. Twist o the protective
cover of the lancet and set it aside.
Keep the protective cover to replace on
top of the used lancet after testing.

Step 4

Replace cap on the lancing device.

A minimum volume of 0.5
microliter is needed to ll the
conrmation window.

Approximate size

Step 3

After the symbol appears
on the screen, apply the

Sucient

Sample

If the conrmation window is not lled in time because of
abnormally high viscosity (thickness or stickiness) or insucient
volume, an ‘Er4’ message may appear. It is recommended that the
application of blood sample to the test strip be performed virtually
vertical to the sample site as shown in the diagram below.

test result is displayed, the meter will automatically switch o
after three (3) seconds. Discard used test strip safely in a
disposable container.

NOTE

• The meter will switch o if the blood sample is not applied
within two (2) minutes of the symbol appearing on
the screen.

• If the meter turns o, remove the test strip, reinsert it, and
start from Step 2.

Insucient

Sample

Step 4

The test result will appear after the
meter counts down from ‘5’ to ‘1’.
The result will be automatically stored
in the meter’s memory.
If the test strip is removed after the

blood sample to the narrow
end of the test strip until the
meter beeps.

Discarding Used Lancets

Step 1

Pinch and pull the cap to remove.

Alternate Site Blood Sampling
(forearm, palm, thigh, calf)

Select a clean, soft and eshy sample site area free of visible veins
and hair and away from bones. Gently massage the sample site
to help blood circulation to minimize result dierences between
ngertip and alternate site sampling. Firmly press and hold the
lancing device against 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 sucient (at least 0.5 μL) blood is drawn.
Carefully lift the lancing device away from your skin.

CAUTION

• AST results should never be used to calibrate Continuous
Glucose Monitoring Systems nor entered into an insulin
dosing calculator or pump for dosing recommendations.

Things to know when using AST

Please read the following before testing at alternate sites
(forearms, palms, thighs, and calves). The capillary whole blood of
the ngertips reects changes in glucose levels more rapidly than
in alternate sites. The test results from the ngertip testing and
AST may dier due to factors such as lifestyle and eating food
which aect glucose levels.

Acceptable situations for AST

• Fasting period

• Before a meal

Situations requiring ngertip test

• When the glucose levels are rapidly increasing, such as

during two (2) hours after a meal or exercise.

• When sick or when glucose levels seem quite lower than

test value.

• When hypoglycemia is not well recognized.

• When insulin has the biggest eect.

• Two (2) hours after an insulin injection.

AST Precautions

• Do not ignore the symptoms of hyperglycemia or hypoglycemia.

• When the results of the test do not reect the way you feel, retest
using the ngertip. If the ngertip result still does not reect the
way you feel, please consult your healthcare professional.

• Do not rely on AST results for changing your treatment method.

• The amount of glucose in alternate sites diers from person
to person.

• Before using AST, please consult your healthcare professional.

1 3 5 7 9 11 13

01- Important Information: Read this First

To receive safe and optimum system benets, please read
the entire manual contents before using the system. Please note
the following instructions:

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

• Use only fresh capillary whole blood samples for testing.

• Alternate site and ngertip test results may dier signicantly
due to rapid changes in the glucose level after eating, insulin
injection or exercise.

Intended Use

• The ReliOn™ Premier Compact Blood Glucose Monitoring System
is intended for the quantitative measurement of glucose in fresh
capillary whole blood samples drawn from the ngertips and
alternate sites such as the forearm, palm, thigh and calf.

• Alternate site testing should be used only during steady-state
blood glucose conditions.

• The ReliOn™ Premier Compact Blood Glucose Monitoring System
is intended for use outside the body (in vitro) by people with
diabetes, at home, as an aid to monitor the eectiveness of
diabetes control.

• The system is intended to be used by a single person and should
not be shared.

• The system is not intended for use on neonates, and is not for the
diagnosis or screening of diabetes.

• ReliOn™ Premier Blood Glucose Test Strips are for use with the
ReliOn™ Premier family of blood glucose meters to quantitatively
measure glucose in fresh capillary whole blood samples drawn
from the ngertips and alternate sites.

• ReliOn™ Premier Control Solutions are for use with the ReliOn™
Premier family of blood glucose meters and ReliOn™ Premier Test
Strips to check that the meter and the test strips are working
together properly and that the test is performing correctly.

Important Information

• The ReliOn™ Premier Compact Blood Glucose Monitoring System
is intended for in vitro (outside the body) diagnostic use only
and for the quantitative measurement of glucose in capillary
whole blood.

• The ReliOn™ Premier Compact Blood Glucose Monitoring System
is intended for use by a single user only. Do not share the meter
and lancing device with anyone including other family members.
Never use on multiple users.

• The ReliOn™ Premier Compact Blood Glucose Meter is designed
to minimize code related errors in monitoring by using the no
coding function.

• The ReliOn™ Premier Compact Blood Glucose Meter should be

used only with ReliOn™ Premier Blood Glucose Test Strips.

2 4 6 8 10 12 14

• Operating range
Temperature: 50–104°F (10–40°C)
Relative humidity: 10–90%
Hematocrit: 20–60%

03 - ReliOn™ Premier Blood Glucose Test Strip

The ReliOn™ Premier Compact Blood Glucose Monitoring System
measures blood glucose quickly and accurately. It automatically
absorbs the small blood sample applied to the narrow edge of
the test strip.

1. Contact bars

Gently push the test strip, with its
contact bars facing up, into the test strip
port of meter.

2. Conrmation window

Check here to see whether sucient
blood sample has been applied.

3. Edge to apply blood sample

Apply blood sample here for testing.

Important Safety Instruction

• All components that come into contact with blood samples
should be considered to be biohazardous and capable of
transmitting viral diseases, even after disinfection.

• Do not share the meter or lancing device with another person.

• ReliOn™ Premier Test Strips should be used only with fresh
capillary whole blood samples.

• Do not reuse test strips.

• Do not use ReliOn™ Premier Test Strips beyond the expiration
date. This may cause inaccurate results.

• When test strips are used and stored according to correct storage
and handling methods, both new, unopened vials and vials that
have been opened can be used until the expiration date printed
on the test strip box and vial label.

• Store test strips in a cool and dry place at a temperature between
34–86°F (1–30°C).

• Keep test strips away from direct sunlight or heat, and do
not freeze.

• Store test strips only in their original vial.

• Close the vial tightly after taking out a test strip and use the strip
immediately.

• Handle test strips only with clean, dry hands.

• Do not bend, cut or alter test strips in any way.

• For detailed storage and usage information, refer to the
ReliOn™ Premier Test Strip package insert.

•

Keep the meter and testing supplies away from young children.

05 - Checking the System

ReliOn™ Premier Compact Blood Glucose Meter
and Test Strips should be checked using ReliOn™
Premier Control Solutions, available in two levels
(Level 1 and 2). The ReliOn™ Premier Control
Solutions contain known amounts of glucose and are
used to check that the meter and the test strips are
working properly.

The test strip vials have ReliOn™ Premier Control
Solution ranges printed on their labels. Compare the
result displayed on the meter to the ReliOn™ Premier
Control Solution range printed on the test strip vial.

Before using a new meter or a new vial of test strips, you should
conduct a control solution test following the procedure on page 7
with ReliOn™ Premier Control Solutions.

NOTE

• Use ReliOn™ Premier Control Solutions only (available for
purchase separately).

• Check the expiration dates printed on the bottle. When you
rst open a control solution bottle, record the discard date
(date opened plus three (3) months) in the space provided on
the label.

• Make sure your meter, test strips and control solutions are at
room temperature before testing. Control solution tests must be
done at room temperature (68–77°F, 20–25°C).

• Before using the control solution, shake the bottle, discard the
rst 1 or 2 drops and wipe the tip clean.

• Close the control solution bottle tightly and store at a
temperature of 46–86°F (8–30°C).

Use ReliOn™ Premier Control Solution when:

• You want to practice the test procedure using the control
solution, instead of blood.

• You use the meter for the rst time.

• You begin using a new vial of test strips.

• You suspect that the meter or the test strips are not
working properly.

• You think your test results are inaccurate or they do not
reect how you feel.

• The meter is dropped or damaged.

• You use the meter for blood glucose test after any
disinfection procedure.

Comparing the Control Solution Test Results

The test result of each control solution should be within the range
printed on the label of test strip vial. Repeat the control solution
test if the test result falls outside of this range. Out of range results
may occur due to the following factors:

Situations

• When the control solution bottle was
not shaken well.

• When the meter, test strip, or the
control solution were exposed to high
or low temperatures.

• When the rst drop of the control
solution was not discarded or the tip of
the bottle was not wiped clean.

• When the meter is not functioning
properly.

• When the control solution is past the
expiration date printed on the bottle.

• When the control solution is past its
discard date (the date the bottle was
opened plus three (3) months).

• When the control solution is
contaminated.

CAUTION

• If results continue to fall outside the range printed on the test
strip vial, the meter and test strip may not be working properly.
Do not use your system and contact Customer Service:
1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.

NOTE

• The ReliOn™ Premier Control Solution can be purchased
separately. Contact Customer Service: 1-855-776-0662, 7 a.m.
to 7 p.m. Central time, 7 days a week.

Actions

Repeat the control
solution test by
referring to the ‘NOTE’
on page 6.

Discard the used
control solution and
repeat the test using a
new bottle of control
solution.

06 - Using the Lancing Device

You will need a lancing device in order to collect a blood sample.
You may use the lancing device contained in the ReliOn™ Premier
Compact Blood Glucose Monitoring System or any other medically
approved lancing device.

NOTE

• The skin depth to get blood samples will vary for various people
at dierent sample sites.

• The adjustable tip of the lancing device allows the best depth of
skin penetration for an adequate sample size.

• A beginning setting of three (3) is recommended.

07 - Testing Your Blood Glucose Level

Step 1

Insert a test strip with the contact bars facing upwards into the
meter's test strip port. Push the test strip gently into the test strip port
until the power automatically turns on and the symbol appears.

Step 2

Obtain a blood sample using the lancing device. Place the device
against the pad of the nger. The best puncture sites are on the
middle or ring ngers. Press the release button. Remove the device
from the nger. Wait a few seconds for a blood drop to form.

Step 5

The lancing device has seven (7)
puncture depth settings. The shorter
lines are for a shallower puncture
and the longer lines are for a deeper
puncture. Adjust the depth of puncture
as necessary.

Step 6

Cock the lancing device by holding the
body in one hand and pulling on the
charger. A click may be heard.

CAUTION

• Check for damages before using the lancet. If they have
been damaged, please discard it and use other lancet.

• The lancet is very sharp. Please keep away from children.

• Keep the lancets in a cool and dry place.

• The lancet is for single use only.

• Never share or reuse a lancet.

• Always dispose of lancets properly.

08 - Alternate Site Testing

What is AST (Alternate Site Testing)?

When someone tests their glucose, they take the blood sample
from the tip of the nger. However, since there are many nerve
endings distributed there, it can be painful.

When doing a glucose test, using dierent parts of the body,
such as the forearms, palms, thighs and calves, can reduce the
pain during testing. This method of testing with dierent parts
of the body is called Alternate Site Testing. While AST may reduce
the pain during testing, it may not be simple for everyone and
the following precautions should be observed during testing.

Step 2

Place the protective cover on the lancet.
Push the lancet ejector forward with the
thumb to dispose of the used lancet in a
proper biohazard container.

NOTE

• Results from alternate site and ngertip samples may dier from
each other, as there is a time lag for the glucose levels to reach
the same value.

• Use a ngertip sample if you suer from hypoglycemia, or have
experienced hypoglycemic shock or symptoms.

• If the sample drop of blood runs or spreads due to contact with
hair or with a line in your palm, do not use that sample. Try
puncturing again in a smoother area.

09 - ‘HI’ and ‘Lo’ Messages

The ReliOn™ Premier Compact Meter displays test results
between 20 to 600 mg/dL.

‘HI’ appears when the blood
glucose level is greater than
600 mg/dL and indicates severe

HI Message

Lo Message

NOTE

• If the messages persist, please contact Customer Service:
1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.
At all other times or in case of emergency, contact your
healthcare professional or emergency medical response.

hyperglycemia (much higher
than normal glucose levels). If ‘HI’
is displayed again on retesting,
please contact your healthcare
professional immediately.

‘Lo’ appears when a test result is
less than 20 mg/dL and indicates
severe hypoglycemia (very low
glucose levels). If ‘Lo’ is displayed
again on retesting, please contact
your healthcare professional
immediately.

Use with ReliOn Premier Blood Glucose Test Strips.

SGA1E0112 REV0 03/2018 XXXX-00 Rev. 03/18 Product of Korea.

For self-testing use only.

For in vitro diagnostic use only.

For single user / home use only.

3mA, 3V (CR2032 x 1)

Distributed by

Wal-Mart Stores, Inc.

Bentonville, AR 72716

1-855-776-0662

Premier COMPACT

Blood Glucose Meter

10 - Viewing Test Results in Meter Memory

Step 1

The meter memory can store up to ten (10)
results at one time. The results will be saved
in the order it was measured and you can
view stored results by pushing the

button.

Step 2

When the button is pushed, number ‘1’ will
appear on the screen for one (1) second

and then the result will be shown. This
is the most recent test result that is saved in the memory. To go
on to the second recent result, press the button again. Now
number ‘2’ will appear for one (1) second and the next result will be
displayed. By repeating this process, you can go through to result
number 10 which is the oldest data saved in the memory. To exit
from the memory mode, press and hold down the button for
about two (2) seconds. The meter will turn o.

11 - Understanding Error Messages

A used test strip was inserted.

-> Remove the strip and reinsert a new
test strip.

The blood or control solution sample
was applied before the symbol
appeared.

-> Repeat the test with a new test strip
and wait until the symbol appears
before applying the blood or control
solution sample.

The temperature during the test was
above or below the operating range.

-> Move to an area where the
temperature is within the operating
range (50–104˚F/10–40°C) and repeat
the test after the meter and test strips
have reached a temperature within
the operating range.

The blood sample has abnormally high
viscosity or insucient volume.

-> Repeat the test after inserting a new
test strip.

We have validated Clorox® Germicidal Wipes
with 0.55% sodium hypochlorite as the active
ingredient for disinfecting the ReliOn™ Premier
Compact Meter and lancing device. It has been
shown to be safe for use with the meter and
lancing device. This disinfectant is available
commercially in towelette form. In addition
to ReliOn™ Premier Compact User Manual,

please read the instructions provided by the
manufacturer of Clorox® Germicidal Wipes before using it.

Name Clorox® Germicidal Wipes

Manufacturer Clorox® Professional Products Company

Phone: [phone]
Website: www.cloroxprofessional.com

EPA registration
number

Active
ingredients

NOTE

• The disinfectant products can be purchased online retailers (e.g.
Walmart) or by telephone at the manufacturer.

• To nd out where to purchase the disinfectant product, please
contact the manufacturer or visit their websites as listed above.

67619-12

Sodium Hypochlorite: 0.55%

Pre-Cleaning and Disinfection Procedure

Open the cap of the Clorox® Germicidal Wipes container



and pull out one (1) towelette and close the cap.

Front

Wipe the entire surface of the meter three (3) times horizontally



and three (3) times vertically using one towelette to pre-clean
blood and other body uids.

Back

Both sides

Caution

• Do not use other cleaners or disinfectants because other
chemicals have not been validated and may damage the meter.

• Do not get uids inside the meter through the test strip port or
battery compartment. Never immerse the meter or hold it under
running water because this will damage the meter.

Storage and Handling

• Keep the meter in a cool and airy place.

• Do not expose the meter to direct sunlight or heat for extended
periods of time.

• Do not let dirt, dust, blood or water enter into the meter’s test
strip port.

• Do not drop the meter or subject it to strong shocks.

• Do not try to x or alter the meter in any way.

• Strong electromagnetic radiation may interfere with the proper
operation of this device. Keep the device away from sources of
strong electromagnetic radiation.

• Store all meter components in the carrying case to prevent loss.

NOTE

• For additional information or technical assistance contact
Customer Service: 1-855-776-0662, 7 a.m. to 7 p.m. Central time,
7 days a week.

13 - Replacing the Battery

The ReliOn™ Premier Compact Meter uses one 3.0 V lithium battery
(non-rechargeable, replaceable, type CR2032).

Before using the meter, check the battery compartment and insert
battery if empty.

If blinks when the meter is turned on or a test strip is
inserted, it means there is not enough power for tests. So, the
battery needs to be changed.

The test results might not be saved if the battery runs out.

Step 1

Make sure that the meter is turned o.
Push the cover down slightly and in
the direction of the arrow to open the
battery compartment.

Step 2

Remove the used battery and insert a
new battery with the '+' side facing up.
Make sure the battery is inserted rmly.

- The meter will not operate if the
battery is inserted upside down.

Precision: Precision studies were performed in a
laboratory using the ReliOn™ Premier Compact System.

Within Run Precision

Blood avg. 38 mg/dL SD = 1.9 mg/dL

Blood avg. 86 mg/dL SD = 3.2 mg/dL

Blood avg. 125 mg/dL CV = 4.1%

Blood avg. 189 mg/dL CV = 2.6%

Blood avg. 334 mg/dL CV = 2.8%

Total Precision

Control avg. 35 mg/dL SD = 1.2 mg/dL

Control avg. 116 mg/dL CV = 2.4 %

Control avg. 324 mg/dL CV = 2.3%

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

Within ± 5 mg/dL Within ±10 mg/dL Within ±15 mg/dL

Fingertip 1/2 (50%) 2/2 (100%) 2/2 (100%)

Forearm 1/2 (50%) 2/2 (100%) 2/2 (100%)

Palm 2/2 (100%) 2/2 (100%) 2/2 (100%)

Thigh 1/2 (50%) 2/2 (100%) 2/2 (100%)

Calf 1/2 (50%) 2/2 (100%) 2/2 (100%)

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

Fingertip

Forearm

Palm

Thigh

Calf

Within ±

5 %

27/48(56.3%) 46/48(95.8%) 48/48(100%) 48/48(100%

19/48(39.6%) 42/48(87.5%) 47/48(97.9%) 48/48(100%)

28/48(58.3%) 38/48(79.2%) 46/48(95.8%) 48/48(100%)

17/48(35.4%) 36/48(75.0%) 46/48(95.8%) 48/48(100%)

27/48(56.3%) 46/48(95.8%) 48/48(100%) 48/48(100%)

Within ±

10%

Within ±

15 %

Within ±

20 %

ReliOn® Premier Compact Quick Reference Guide

1

2

5 6 8

9

10

3

7

4

11

15 17 19 21

This error message may appear when
the wrong blood glucose test strip
is used instead of the ReliOn™ Premier
Blood Glucose Test Strip.

-> Repeat the test with a ReliOn™
Premier Blood Glucose Test Strip.

There is a problem with the meter.

-> Do not use the meter. Contact
Customer Service: 1-855-776-0662.

NOTE

• If the error messages persist, contact Customer Service:
1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.

12 - Caring for the ReliOn™ Premier

Compact System

• To minimize the risk of transmission of bloodborne pathogens,
the pre-cleaning and disinfection procedure should be performed
as recommended in the instructions below.

• Wash your hands thoroughly with soap and water after handling
the meter, lancing device or test strips.

• If the meter is being operated by a second person who is
providing testing assistance to the user, the meter and lancing
device should be disinfected prior to use by the second person.

Pre-cleaning and Disinfection

The pre-cleaning procedure is needed to clean dirt as well as
blood and other body uids on the exterior of the meter and
lancing device before performing the disinfection procedure.
The disinfection procedure is needed to prevent transmission of
bloodborne pathogens.

• For the meter and lancing device, this pre-cleaning and
disinfection procedure should be performed once per week.

NOTE

• The life span of a ReliOn™ Premier Compact Meter is 5 years.
We recommend disinfecting both the meter and lancing device
at least once per week. We have validated a total of 260 cleaning
and disinfecting cycles (260 pre-cleaning and 260 disinfection
cycles) to represent weekly cleaning and disinfecting over the
use life of your meter and lancing device.

1 pre-cleaning and 1 disinfection cycles per week x 52 weeks per

year x 5 years = 260 pre-cleaning and 260 disinfection cycles.

16 18 20 22

Dispose of the used towelette in a trash bin.



Pull out one (1) new towelette and wipe the entire surface of the



meter three (3) times horizontally and three (3) times vertically
using a new towelette to remove bloodborne pathogens.

dry cloth

Dispose of the used towelette in a trash bin.



Allow exteriors to remain wet for one (1) minute, then wipe



the meter using a dry cloth

Repeat the same procedure for the lancing



device (step  to step ).

NOTE

• After the pre-cleaning and disinfection procedure, the control
solution should be tested to conrm that the meter works
properly before using the meter.

• Control solution tests should be performed with two dierent
levels of ReliOn™ Premier Control Solutions (Level 1 and/or
Level 2).

•

Verify that the test results are within the range printed on the
test strip vial. See page 7 for how to do a control solution test.

NOTE

• If any of the following deterioration signs appear after
pre-cleaning or disinfecting, please stop using the system
and contact Customer Service: 1-855-776-0662, 7 a.m. to 7 p.m.
Central time, 7 days a week.

- The inscriptions on the exterior of the meter (or lancing device)

have been removed.

- The color of the meter (or lancing device) has changed

or faded.

- Cracks or roughness develop on the meter (or lancing device).

- A part of the segment on the meter display does not ash.

- Control solution test results do not fall within the stated range

on the test strip vial.

.

Caution

• There is a risk of explosion if the battery is replaced with an
incorrect type. Please dispose of the used battery according to
your local regulations.

14 - Performance Characteristics

The performance of ReliOn™ Premier Compact Blood Glucose
Monitoring System has been evaluated in laboratory and
clinical tests.

Accuracy

The ReliOn™ Premier Compact Blood Glucose Monitoring
System is calibrated to yield results equivalent to plasma glucose
concentrations. The accuracy of the ReliOn™ Premier Compact
System (Model GM505VAA) was tested 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.

Slope 1.023 1.032

Y-intercept -1.86 mg/dL -3.63 mg/dL

Correlation coecient(r) 0.995 0.985

Number of sample 110 105

Range tested 30-485 mg/dL 67-413 mg/dL

• Accuracy results for glucose concentration < 75 mg/dL

Within ± 5 mg/dL Within ±10 mg/dL Within ±15 mg/dL

14/17 (82%) 17/17 (100%) 17/17 (100%)

•

Accuracy results for glucose concentration ≥ 75 mg/dL

Within ± 5 % Within ± 10 % Within ± 15% Within ± 20 %

54/93 (58%) 82/93 (88%) 93/93 (100%) 93/93 (100%)

Step 3

Place the cover on the battery
compartment. Push cover in the
direction of the arrow to close.
A click may be heard.

Obtained by
healthcare
professionals

Obtained by
lay users

15 - Warranty Information

Warranty

The manufacturer warrants that the ReliOn™ Premier Compact Meter
shall be free of defects in material and workmanship in normal use
for a period of 5 years.

The meter must have been subjected to normal use. The warranty
does not cover improper handling, tampering, use or service of the
meter.

Any claim must be made within the warranty period.

The manufacturer will, at its discretion, repair or replace a defective
meter, or meter part that is covered by this warranty.

As a matter of warranty policy, the manufacturer will not reimburse
the consumer's purchase price.

Obtaining Warranty Service
To obtain warranty service, you must return the defective meter or
meter part along with proof of purchase.

Returns
For instruction on how to return your meter, contact Customer
Service: 1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.

Meters returned without this authorization will not be accepted.

DISTRIBUTED BY:

Wal-Mart Stores, Inc.

Bentonville, AR 72716

www.ReliOnBGM.com

Customer Service

1-855-776-0662

7 a.m. to 7 p.m. Central time, 7 days a week.

At all other times or in case of emergency, contact your
healthcare professional or emergency medical response.

©2019. All Rights Reserved.
P/N 5540-02 Rev. 03/19
PGUAA-0000014 Rev2 03/2019

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mg/dL