ReliOn Premier VOICE User manual

Para un solo usuario / uso domiciliario únicamente
Para el uso con tiras de prueba ReliOn™ Premier únicamente.
Las tiras de prueba se venden por separado.
Manual
del
Usuario
For single user / home use only
For use with ReliOn™ Premier Test Strips only.
Test strips sold separately.
User
Manual

Servicio al cliente
1-855-776-0662
De 7 a.m. a 7 p.m., hora del centro,
los 7 días de la semana.
En caso de emergencia, póngase
en contacto con su profesional de
atención médica o con un servicio de
respuesta ante emergencias médicas.
DISTRIBUIDO POR:
Wal-Mart Stores, Inc.
Bentonville, AR 72716
www.ReliOnBGM.com
© 2017. Todos los
derechos reservados.
5404-00 Rev. 07/17
PGK7E1002 Rev0 07/2017
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
© 2017. All Rights Reserved.
5404-00 Rev. 07/17
PGK7E1002 Rev0 07/2017
Welcome to the ReliOn™ Premier Voice Blood Glucose
Monitoring System
Thank you for choosing the ReliOn™ Premier Voice Blood Glucose
Monitoring System. The system provides you with safe, fast
and convenient blood glucose in vitro (i.e., outside the body)
monitoring. The bilingual talking function of ReliOn™ Premier
Voice Meter can be used as an aid for using the meter.
The ReliOn™ Premier Voice Meter is also designed to minimize
code related errors in monitoring by using the auto coding
function. You’ll receive an accurate result in five seconds with a
small 0.5 μL blood sample.
This booklet contains important information about the ReliOn™
Premier Voice Glucose Monitoring System.
Please read it carefully before testing your blood glucose.
Bienvenido al Sistema de monitoreo de glucosa en sangre
ReliOn™ Premier Voice
Gracias por elegir el Sistema de monitoreo de glucosa en sangre
de voz ReliOn™ Premier. El sistema le proporciona un monitoreo
seguro, rápido y cómodo para el control de glucosa en sangre
invitro (es decir, externo). La función de voz bilingüe del medidor
de voz ReliOn™ Premier se puede usar como una ayuda para el
uso delmedidor.
El medidor de voz ReliOn™ Premier también está diseñado para
minimizar los errores relacionados con el código en el monitoreo
mediante el uso de la función con codificación automática.
Usted recibirá un resultado preciso en cinco segundos con una
pequeña muestra de sangre de 0.5 μL.
Este manual contiene información importante acerca del Sistema
de monitoreo de glucosa en sangre de voz ReliOn™ Premier.
Léalo atentamente antes de realizar la prueba de glucosa
en sangre.

3
Table of Contents
Information
Important Information: Read This First 4
Important Health-related Information 5
Specifications 7
ReliOn™ Premier Voice Blood Glucose Monitoring System (BGMS) 8
Inserting or Replacing the Batteries 9
ReliOn™ Premier Blood Glucose Test Strip 10
ReliOn™ Premier Voice Blood Glucose Meter 12
ReliOn™ Premier Voice Blood Glucose Meter Display 13
Preparation
Setting Up the ReliOn™ Premier Voice System 14
Adjusting Language, Date, Time and Sound 14
Setting the Hypoglycemia Indicator 17
Checking the System 19
Control Solution Testing 20
Comparing the Control Solution Test Results 23
Blood Glucose Testing
Using the Lancing Device 24
Preparing the Lancing Device 25
Preparing the Meter and Test Strip 27
Flagging Post-meal Test Results 28
Applying the Blood Sample 29
Discarding Used Lancets 31
Alternate Site Testing 32
‘HI’ and ‘Lo’ Messages 35
Target Blood Glucose Ranges 36
Transferring Test Results 37
Additional Functions
Meter Memory 38
Viewing Past Test Averages 38
Viewing Test Results 40
Setting the Alarm Function 41
Setting the Post-meal Alarm (PP2 Alarm) 41
Setting the Time Alarms (Alarm 1–3) 42
Maintenance
Caring for the ReliOn™ Premier Voice System 44
Pre-cleaning and Disinfection 44
Pre-cleaning and Disinfection Procedures 46
Caution: Storage and Handling 49
Understanding Error Messages 50
General Troubleshooting 53
Performance Characteristics 54
Warranty Information 57
Notes 58

4
Important Information: Read This First
To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note the
following information.
• Do not use the system for diagnosis or screening of diabetes.
• Use only fresh capillary whole blood samples for testing.
• Alternate site and fingertip test results may differ significantly
due to rapid changes in the blood glucose level after eating,
insulin injection or exercise.
Intended Use
• The ReliOn™ Premier Voice Blood Glucose Monitoring System is
intended for the quantitative measurement of 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 should be used only during steady-state
blood glucose conditions.
• The ReliOn™ Premier Voice Blood Glucose Monitoring System is
intended for at-home in vitro (outside the body) self-testing by
people with diabetes as an aid in monitoring the effectiveness
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.

5
• ReliOn™ Premier Blood Glucose Test Strips are for use with the
ReliOn™ Premier Voice Blood Glucose Meter to quantitatively
measure glucose in fresh capillary whole blood samples drawn
from the fingertips and alternate sites.
• ReliOn™ Premier Control Solutions are for use with the ReliOn™
Premier Voice Meter and ReliOn™ Premier Test Strips to check
that the meter and test strips are working together properly,
and that the test is performing correctly.
• The
ReliOn™ Premier
Voice 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
Voice Blood Glucose Monitoring System
is intended for use by a single user only. Do not share the
meter and lancing device with another person.
• The
ReliOn™ Premier
Voice Blood Glucose Meter is designed
to minimize code-related errors in monitoring by using the
no-coding function.
• Glucose in blood samples reacts with the chemical in the
test strip to produce a small electrical current. The
ReliOn™
Premier
Voice Meter converts this electrical current to
glucose concentration.
• The
ReliOn™ Premier
Voice Blood Glucose Meter should be
used only with the
ReliOn™ Premier
Test Strips.
• An abnormally high or low red blood cell count (hematocrit
level over 60% or below 20%) may produce inaccurate results.
Important Health-related Information

6
• Inaccurate results may occur in severely hypotensive (having
low blood pressure) individuals or patients in shock.
• Inaccurate low results may occur for individuals experiencing a
hyperglycemic-hyperosmolar state, with or without ketosis.
• Inaccurate results may occur in patients undergoing
oxygen therapy.
• Critically ill patients should not be tested with blood
glucose meters.
• All parts of this 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, please contact your
healthcare professional or emergency medical response.

7
Specifications
Operating ranges
Temperature 50–104˚F (10–40˚C)
Relative humidity 10–90%
Hematocrit 20–60%
Product specifications
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
Assay method Electrochemical
Battery life 1,000 tests
Power Two alkaline AAA batteries
Memory 500 test results
Size 3.90 x 2.21 x 0.75 inches (100 x 56 x 19 mm)
Weight 2.47 oz (70 g) with batteries

8
ReliOn™ Premier Voice Blood Glucose Monitoring System
ReliOn™ Premier Voice Blood Glucose Monitoring System
(BGMS) includes the following items:
➊
ReliOn™ Premier Voice Blood Glucose Meter
➋
User Manual
➌
Quick Reference Guide
➍
Batteries
➎
Logbook
➏
Carry Case
• Check all the components after opening the ReliOn™
Premier Voice Blood Glucose Monitoring System package.
• ReliOn™ Premier Control Solutions are necessary but
not included.
• ReliOn™ Premier Control Solutions and data cable for the
diabetes management system 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.
CAUTION
• 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.

9
Inserting or Replacing the Batteries
Step 1
Make sure the meter is turned off. Press
firmly on the battery cover and slide in
the direction of the arrow. Then swing
it open.
Step 2
Remove the used batteries and insert
the two new batteries. Close the battery
cover firmly.
• The ReliOn™ Premier Voice Meter uses two AAA alkaline
batteries.
• Before using the meter, check the battery compartment and
insert batteries if empty.
• When the symbol appears on the display while the meter
is in use, the batteries should be replaced as soon as possible.
• Test results may not be saved if the batteries run out completely.
NOTE
•Removing the meter batteries will not
affect your stored results. However,
meter setting may need to be reset,
see page 14.
ReliOn™ Premier Voice Blood Glucose Monitoring System

10
ReliOn™ Premier Blood Glucose Test Strip
The ReliOn™ Premier Voice Blood Glucose Monitoring System
measures blood glucose quickly and accurately. It automatically
absorbs the small blood sample applied to the narrow edge of
the strip.
Important Safety Instructions
• 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.
• The ReliOn™ Premier Test Strips should be used only with fresh
capillary whole blood samples.
• Do not reuse test strips.
Insert
Contact bars
Gently push the test strip, with its
contact bars facing up, into the test
strip port of meter
Confirmation window
Check here to see whether sufficient
blood sample has been applied
Edge to apply blood sample
Apply blood sample here for testing

11
• 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 for testing
and use the test 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 Strips package insert.
• Keep meter and testing supplies away from young children.
NOTE
•You can get more safety information at FDA Public
Health Notification (www.fda.gov/medicaldevices/safety/
alertsandnotices/ucm234889.htm) or at CDC Clinical
Reminder (www.cdc.gov/injectionsafety/Fingerstick-
DevicesBGM.html).

12
ReliOn™ Premier Voice Blood Glucose Meter
Data Port
Used to transfer data from the
meter to a computer with a
data cable
Button
Turns the meter
on/off, confirms
menu selections
< Button
Selects or
changes
information
Display
Shows results
and messages
Test Strip Port
Insert test strip here
> Button
Selects or
changes
information
Speaker
Announces each step
Test Strip Ejector
Slide down to discard
used strips
NOTE
•The data cable for the data management software can be
ordered separately. Please contact Customer Service:
1-855-776-0662, 7 a.m. to 7 p.m. Central time, 7 days a week.

13
ReliOn™ Premier Voice Blood Glucose Meter Display
alarm:
appears when the time alarm
has been set
mem: appears when test results
stored in the memory are displayed
ctl: appears when the control
solution test results are displayed
Test results
Blood insertion symbol: indicates
meter is ready for the application of
a drop of blood or control solution
Temperature symbol
01
02
03
04
05
06
Post-meal test flag: appears during post-meal testing and
when post-meal test results are displayed
Hypoglycemia symbol: appears when the test result is
below the hypoglycemic level
Post-meal alarm symbol: appears when the post-meal
alarm has been set
Mute symbol: appears only when the sound is set to ‘OFF’
Battery symbol: indicates meter batteries are running low
and need to be replaced
mg/dL: unit for measuring blood glucose
Date / temperature Time
09
10
11
12
13 14
07
08
NOTE
• It is recommended to check if the display screen on the meter
matches the illustration above every time the meter turns on.
• Do not use the meter if the display screen does not exactly
match the illustration as the meter may show incorrect results.
01
07 08 09 10
02 03
04
05
12
06
11
13 14

14
Setting Up the ReliOn™ Premier Voice System
Meter settings, such as time and date, should be checked and
updated before using the meter or after changing the meter batteries.
Press and hold the button for 3 seconds to enter the ‘SET’ mode.
While setting up the meter, current settings will appear on the
display. The meter will also announce each function when the
talking function is on. Press and hold the <or >button to scroll
faster. To complete the settings and exit from the ‘SET’ mode, press
and hold the button for 3 seconds again.
Adjusting Language, Date, Time and Sound
Step 1 Entering the ‘SET’ Mode
Press and hold the button for 3 seconds. After
all the segments flash across the screen, ‘SET’ is
displayed on the screen. If the talking function
is on, the meter will say “Set meter.” Press the
button again to progress to the next step.
Step 2 Selecting a Language
The meter has a bilingual, talking
function that can be used as a verbal
aid for using the meter and hearing
test results.
When entering the language selection
mode for the first time, ‘L1’ will be
blinking and the meter will announce
“Language Selection” in the default language, English.
To select another language (L2, Spanish), press the < or >
button. Press the button to confirm the language and
progress to the next step.

15
Step 4 Setting the Month
A number indicating the month will blink on
the bottom left corner of the screen. If the
talking function is on, the meter will say
“Set month.” Press
the < or > button
until the
correct month appears. Press the button
to confirm the selection and progress to the
next step.
Step 5 Setting the Date
The meter will say “Set date” when the talking
function is on. Press
the < or > button
until
blinking number shows the correct date. Press
the button to confirm the date and progress
to the next step.
Step 3 Setting the Year
The meter will say “Set year” if the talking
function is on. Press
the < or > button
until
correct year appears. Press and hold the
<
or
>
button to scroll faster. After setting the year,
press the button to confirm the selection
and progress to the next step.

16
Step 6 Setting the Time Format
The meter can be set in the 12-hour (AM/PM)
or the 24-hour clock format.
If the talking function is on, the meter will say
“Set time 12-hour / 24-hour.” Press
the < or >
button
to select a format. The AM/PM is not
displayed in the 24-hour format. After selecting
the format, press the button to progress to the
next step.
Step 8 Setting the Minute
If the talking function is on, the meter will say
“Set minute.” Press
the < or > button
until the
correct minute appears. After setting the minute,
press the button to progress to the next step.
Step 7 Setting the Hour
If the talking function is on, the meter will say “Set
hour.” Press
the < or > button
until the correct
hour appears. Press the button to confirm the
hour and progress to the next step.

17
Step 9 Turning the Sound On/Off
A number showing the sound volume will blink and the meter
will say “Set volume.” Press
the < or >
button to adjust the
volume from 1 (lowest) to 3 (highest), or to turn the beep sound
‘OFF’ or ‘On’.
When ‘beep On’ is selected, the meter will beep instead of
announcing messages. To turn off the sound, press the button
when ‘OFF’ blinks on the display. Then the symbol will appear
on the display and the meter will be muted. Press the button
to save the setting and progress to the next step.
NOTE
• symbol is displayed only when the sound is set to ‘OFF.’
Setting the Hypoglycemia Indicator
The meter can indicate a possible low blood glucose test result
(hypoglycemia). The hypoglycemia level can be selected from a
level of 60 to 20 mg/dL.

18
Step 10 Turning on the Hypoglycemia Indicator
When entering the hypoglycemia indicator setting mode,
the symbol and ‘HYPo’ will blink. If the talking function
is on, the meter will say “Set
hypoglycemia indicator.” On pressing
the
< or >
button, the screen will
display ‘On’ or ‘OFF.’ Press button
to set the hypoglycemia level if ‘On’
is selected. The screen will return to
step 2, language selection mode, if
‘OFF’ is selected.
CAUTION
•Ask your healthcare professional to help you decide what your
hypoglycemia level is before setting your hypoglycemic level.
Step 12 Exiting from Set Mode
After completing the meter settings, press and hold the
button for 3 seconds to confirm all settings and exit the ‘SET’
mode. If the talking function is on, the meter will announce the
set date and time for confirmation.
Step 11 Setting Your Hypoglycemic Level
The hypoglycemic level can be set
from 60 to 20 mg/dL. To set your
hypoglycemic level, press the
< or >
button until the level you want appears.
Press the button to confirm.
Then the screen will return to step 2,
language selection mode (See page 14).

19
Checking the System
ReliOn™ Premier Voice Meter and Test Strips should
be checked using ReliOn™ Premier Control Solutions,
available in two levels (Level 1 and 2). ReliOn™ Premier
Control Solutions contain known amounts of glucose
and are used to check that the meter and 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 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
pages 20-22 with ReliOn™ Premier Control Solutions.
NOTE
• Use ReliOn™ Premier Control Solutions only.
• Check the expiration dates printed on the bottle. When the
control solution bottle is first opened, record the discard
date (date opened plus three (3) months) in the space
provided on the label.
• Make sure the 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 first 1 or 2 drops and wipe the tip clean.
• Close the control solution bottle tightly and store at a
temperature between 46–86˚F (8–30˚C).

20
Use ReliOn™ Premier Control Solution when:
• You want to practice the test procedure, instead of using blood
• You use the meter for the first time
• You begin using a new vial of test strips
• You suspect that the meter or the strips are not
working properly
• You think your test results are inaccurate or they
do not reflect how you feel
• The meter is dropped or damaged
Step 1
Insert a test strip into the meter’s test strip
port, with the contact bars facing upwards.
Gently push the test strip into the port until
the meter automatically turns on and the
symbol appears. If the talking function is on,
the meter will say “Blood glucose test. Please
apply blood onto the test strip.”
Control Solution Testing
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