ReliOn Prime Operator's manual

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User
Instruction
Manual
Blood Glucose Monitoring System
™
83-04758B

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CAUTION:
Before using any product to test your blood sugar (blood glucose),
read all instructions and practice the test. Do all quality control checks
as directed and consult with a diabetes healthcare professional. These
recommendations apply to all blood glucose monitoring systems and
are supported by the American Association of Diabetes Educators, the
American Diabetes Association, the U.S. Food and Drug Administration,
and the Health Industry Manufacturers Association.

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Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Important Information................................8
The ReliOn™ Prime System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Understanding the ReliOn™ Prime Blood Glucose Meter ......10
Explanation of the Full Display Screen ..................11
ReliOn™ Prime Test Strips .............................12
Testing with ReliOn™ Prime Test Strips . . . . . . . . . . . . . . . . . . . .13
Important Test Strip Information .......................14
Changing the Battery ...............................15
Meter Set Up .....................................18
Setting the Time and Date ...........................18
Blood Glucose Testing .................................22
Obtaining a Drop of Blood ...........................22
Performing a Blood Glucose Test . . . . . . . . . . . . . . . . . . . . . . . . .24
TABLE OF CONTENTS

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Alternate Site Testing (AST) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28
Important Information About AST. . . . . . . . . . . . . . . . . . . . . .28
Preparing to Test Your Blood Glucose From an Alternate Site 30
Performing a Blood Glucose Test From an Alternate Site ....31
Using Control Solution ................................36
Recommended Use of Control Solution .................37
Performing a Control Solution Test . . . . . . . . . . . . . . . . . . . . .38
Comparing Control Solution Results . . . . . . . . . . . . . . . . . . . .42
Downloading Test Results to a Computer ..................43
Understanding Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44
Comparing Meter and Laboratory Results ...............44
Expected Blood Glucose Readings .....................47
High Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . . . . .47
Low Blood Glucose Readings . . . . . . . . . . . . . . . . . . . . . . . . .48
Diabetes Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Meter Memory .......................................51

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Marking Results in the Memory .......................51
Marking Control Solution Tests. . . . . . . . . . . . . . . . . . . . . . . .51
Marking Other Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .52
Recalling Results...................................52
Display Screen Images. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
Caring For Your ReliOn™ Prime Blood Glucose Meter . . . . . . . . .62
Cleaning the Meter ................................62
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Specications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .64
Warnings, Precautions, and Limitations. . . . . . . . . . . . . . . . . . . .65
Warranty. ...........................................67

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INTRODUCTION
Thank you for choosing the ReliOn™ Prime Blood Glucose Monitoring
System. Frequent blood glucose testing is important. It tells you how your
diabetes is affected by factors such as medication, diet, exercise, and stress
management. Blood glucose test results can also tell you if your diabetes
is changing in ways that affect your treatment plan. Always consult your
diabetes healthcare professional before making any changes. All of the
information needed to use the ReliOn™ Prime Blood Glucose Monitoring
System is included in this manual. Please read it thoroughly before using the
system. If you have any questions, call Customer Service at 855.776.0662.
Contact your healthcare professional with questions if you are unable to
reach Customer Service.

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Intended Use
The ReliOn™ Prime Blood Glucose Monitoring System is intended for the
quantitative measurement of glucose in fresh capillary whole blood samples
drawn from the ngertips or palm. Testing is done outside the body (In Vitro
Diagnostic Use). It is indicated for use at home (over the counter [OTC]) by
persons with diabetes, or in clinical settings by healthcare professionals, as
an aid to monitor the effectiveness of diabetes control. It is not intended for
the diagnosis of or screening for Diabetes Mellitus, and is not intended for
use on neonates.

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Important Information
• Test results below 70 mg/dL indicate low blood glucose (hypoglycemia).
• Test results above 240 mg/dL indicate high blood glucose (hyperglycemia).
• If results are below 70 mg/dL or above 240 mg/dL, repeat the test.
• If results continue to measure below 70 mg/dL or above 240 mg/dL consult
your diabetes healthcare professional immediately.
• If symptoms are not consistent with test results AND all the instructions
have been followed carefully, contact your diabetes healthcare professional.
• Before testing, it is important to wash hands with soap and warm water.
Dry hands thoroughly. If you use alcohol wipes to cleanse ngers, make
sure the area is dry before lancing nger. Unwashed hands or residual
alcohol may lead to inaccurate readings.
• Before testing, always make sure the meter is at operating temperature
between 50–104°F (10–40°C). Treat test results obtained outside the
optimum temperature range with caution.
• If the meter has been exposed to extreme temperatures, move the meter to
an area within operating range of 50–104°F (10–40°C).

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The ReliOn™ Prime System Includes:
• ReliOn™ Prime Meter
• Carrying Case
• User Instruction Manual
• Other materials required but not provided:
• ReliOn™ Prime Test Strips
• Control Solution
• Lancing Device and/or Lancets
THE RELION™ PRIME SYSTEM

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BACK
Battery Compartment
Cover
UNDERSTANDING THE RELION™ PRIME
BLOOD GLUCOSE METER
FRONT
Display Screen
Back Button
On/Off Button
Forward Button
Test Strip Port
Data
Connection
Port

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Explanation of the Full Display Screen
Time
Date
Average Test
Reading
Control
Solution Test
Low
Battery
Unit of
Measurement
Temperature
Warning
Test Strip
Apply Blood
Insert/Remove
Test Strip
Memory Mode
Error Code
Result Warning
Main Display:
Test Countdown
Test Results
Error Codes
If any part of the display screen is missing when the meter is turned on call
Customer Service at 855.776.0662.

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These capillary action test strips require
only 0.5 microliter (µL) of blood and provide
an end-ll sample application tip for easy
blood application. The ReliOn™ Prime Blood
Glucose Monitoring System measures the
amount of glucose (sugar) in fresh capillary
whole blood. When a drop of blood is added
to the sample application tip, the sample is
drawn into the test strip reaction site. The
glucose in the blood reacts with the enzyme
on the test strip. This reaction produces
a current, proportional to the amount of
glucose in the blood. The meter detects the
current and converts it into a blood glucose
reading.
TEST STRIP
Reaction
Site
Test Strip
Contact Bars
Sample Application Tip
(apply blood to end of test strip,
and capillary action will pull
blood to reaction site quickly
and easily)
RELION™ PRIME TEST STRIPS

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Important Test Strip Information
• Store the test strip bottle in a cool, dry place between 39–86°F (4–30°C).
• Keep away from direct sunlight and heat.
• Do not refrigerate or freeze.
• Do not store or transfer the test strips outside the original bottle.
• As soon as you have removed a test strip, replace the cap securely on
the bottle.
• Use test strips within 90 days (3 months) of opening and not beyond the
expiration date ( ).
The ReliOn™ Prime Blood Glucose Monitoring System works
with the ReliOn™ Prime Blood Glucose Test Strips.
TESTING WITH RELION™ PRIME TEST STRIPS

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Important Test Strip Information
• Write the date of opening on the bottle label to remind you to discard the
strips after 90 days (3 months).
• Do not bend, cut, or alter a test strip.
• Do not reuse a test strip.
• Use only ReliOn™ Prime test strips with the ReliOn™ Prime meter.
• Ensure your hands are clean and dry before handling test strips.

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NOTE:
Changing the battery should only take a few seconds. If the battery is
changed within 30 seconds, the meter memory is not affected. You will not
lose any past test results and the settings are not affected.
However, if it takes longer than 30 seconds to change the battery, or if the
battery is dead before changing it, the time and date settings may need to
be reset.
The rst time the meter is turned on after changing the battery, you may
see a display screen message (E00). This means you should check that the
time and date are correct. See pages 18–21 for detailed instructions on
changing the time and date.
Changing the Battery
The ReliOn™ Prime blood glucose meter has a CR2032 battery installed.

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When the battery power is getting low, your meter shows . You have
enough power for about 100 tests before you need to replace the battery.
If the is ashing, there is only enough power for about 20 tests. Replace
the battery as soon as possible.
When the battery has run out, the meter will not work.
CR2032
3V
+
WARNING:
Keep all batteries out of children’s reach. If a battery is swallowed, consult a
doctor immediately.

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How to Change the Battery
Step 1
Turn the meter off. The battery cover is on the back of the meter.
Step 2
Pull the battery cover up with your nger or ngernail. Remove battery cover.
Step 3
Remove the old battery. If necessary, turn the meter over and tap it gently
against the palm of your hand until the battery falls out. Avoid the use of
sharp objects that may damage the meter.
Step 4
Insert the new battery. The “+” on the battery should be facing up.
Step 5
Replace the battery cover.

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Meter Setup
Before using the ReliOn™ Prime meter for the rst time, you must set the
time and date. You can choose between the 12-hour format (1–12 o’clock
with am or pm) and the Military 24-hour format (0–23). The date format can
either be displayed as month/day (U.S.A. format) or day/month (International
format). Do not perform a blood glucose test until you have set the meter
correctly.
Setting the Time and Date
Step 1: Turn on the meter
Press the On/Off button to turn the meter on. The full screen appears briey.
If any part of the display screen is missing (see page 11), call Customer
Service at 855.776.0662. The meter then displays the time, date, unit of
measurement, and the insert test strip symbol.
Step 2:
Enter setup mode
Press and hold down the On/Off button for more than 2 seconds to enter the
setup mode.

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Step 3: Set the time format
The time can be displayed in either 24-hour format
or 12-hour format with a.m. and p.m. The meter
displays the current time format. To change format,
press either the Back or Forward button. Press the
On/Off button to select the time format. The date
format then appears on the display.
Step 4:
Set the date format
The date format can either be displayed as month/
day (01/31) or day/month (31/01). The meter displays
the current format. To change format, press either
the Back or Forward button. Press the On/Off button
to select the date format. The hour setting then
ashes on the display.
Month/Day
Format
Day/Month
Format

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Step 5: Set the hour
Press and release the Back or Forward button to change the
hour. Hold the Back or Forward button down to scroll through
quickly. When the correct hour is displayed, press the On/Off
button. The minute setting then ashes on the display.
Step 6:
Set the minute
Press and release the Back or Forward button until the correct
minute appears. Hold the Back or Forward button down to
scroll through quickly. When the correct minute is displayed,
press the On/Off button. The month setting then ashes on
the display.
Step 7:
Set the month
(If day/month format is selected, then Step 7 will set day)
Press and release the Back or Forward button until the correct
month appears. Hold the Back or Forward button down to
scroll through quickly. When the correct month is displayed,
press the On/Off button. The day setting then ashes on
the display.
Hour ashing
Minute ashing
Month ashing