NIPRO Diagnostics TRUEyou User manual

OWNER’S
BOOKLET
For assistance, please call
(UK: 0800 08 588 08
Distributed by:
Nipro Diagnostics (UK) Ltd
25 Barnes Wallis Road
Segensworth East
Fareham, Hampshire
PO15 5TT
© 2013 Nipro Diagnostics, Inc.
E4GBY03FD Rev. 20
LIFETIME WARRANTY
0197
Nipro Europe nv
Weihoek 3H
193 0 Zaventem
Belgium

FAST TEST GUIDE
2 SIMPLE STEPS
1Insert test strip 2Apply blood sample
For quick reference only, not intended as a
substitute for complete instructions. Please read
entire Owner’s Booklet and product Instructions
for Use before testing.
Expected Results for people without diabetes1:
Before eating < 6.1 mmol/L
Two hours after meals < 7.8 mmol/L
The TRUEyou Blood Glucose Monitoring System is
intended for the quantitative determination of
glucose in human whole blood taken from the finger
or forearm (capillary) or from the vein (venous).The
System may not be used for neonates. The System is
intended for at-home use (self-testing) and for use by
healthcare professionals in both physicians’ offices
and in acute and convalescent-care bedside testing
facilities in order to assist in the management of
diabetes.
NOTES:

INTRODUCTION
Welcome to the TRUEyou Blood Glucose
Monitoring System
Our Commitment to You
TRUEyou is a simple, accurate way to test whole
blood glucose (sugar) level, anytime, anywhere.
Our goal is to provide quality healthcare products
and dedicated customer service. For questions
about TRUEyou products, please see cover for
phone number.
is booklet contains all the information needed
to get the most from the TRUEyou System. To
start testing quickly, please see the Quick Reference
Guide found inside the front cover of this Owner’s
Booklet.
Please read complete Owner’s Booklet and
all product Instructions for Use before
using the System.
1
Use By
Date
For in vitro
Diagnostic
Testing Only
Lot
Number
Authorised
Representative
SYMBOLS:
Keep
Dry
Caution
Single
Use
Only
Attention! Read
Instructions
for Use.
Sterile
Control
Storage
Temperature
Range
Manufactured
By
Serial
Number
Control
Level
Biological
Risk
Do Not
Resterilise
For
Assistance
Call
Date of
Manufacture
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2
IMPORTANCE OF BLOOD GLUCOSE MONITORING
e more you know about diabetes, the better
you will be able to take care of yourself. A Doctor
or Healthcare Professional will determine target
ranges for blood glucose results and how oen to
test. Having most results within the target ranges
shows how well a treatment plan is working to
control glucose levels. Keeping most results within
the target ranges helps slow or stop complications
of diabetes.
NEVER change a treatment plan without consulting
with a Doctor or Healthcare Professional.
Use of the TRUEyou Blood Glucose Monitoring
System in a manner not specied in this Owner’s
Booklet is not recommended and may aect your
ability to determine true blood glucose levels.
e TRUEyou System is an in vitro (outside
body) quantitative system that is used for self-
testing and point-of-care testing of only human
whole blood. e most accurate results come from
using fresh whole blood taken from the ngertip or
forearm (capillary) or from the vein (venous).
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3
What you need to know when using the
TRUEyou System:
• Read all product instructions for use before
testing.
• Use only TRUEyou Test Strips and TRUEyou
Control Solution with TRUEyou Meter.
• To help prevent false high results, wash hands
before using the System to test blood, especially
aer handling fruit or other foods containing
sugar.
• Perform Control Tests before performing a blood
glucose test for the rst time (see Control Test).
• Remove only one Test Strip at a time from vial
when testing. Recap vial immediately aer re-
moving Test Strip.
• NEVER reuse Test Strips. NEVER wipe Test
Strips with water, alcohol or any cleaner. DO
NOT attempt to clean and re-use Test Strips.
Reuse of Test Strips will cause inaccurate results.
• NEVER add a second drop of sample to Test
Strip. Adding more sample to the Test Strip gives
an error message.
• Venous whole blood collected into sodium or
lithium heparin blood collection tubes may be
used for testing by Healthcare Professionals.
Use of EDTA blood collection tubes is not
recommended and may cause low results. Mix
tube contents gently before using.
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4
IMPORTANT HEALTH and SAFETY
INFORMATION:
e TRUEyou Blood Glucose Monitoring System
is for one person use ONLY. DO NOT share
your Meter or your Lancing Device with anyone,
including family members. DO NOT use on more
than one person. ALL parts of the TRUEyou Blood
Glucose Monitoring System could carry blood-
borne pathogens aer use, even aer cleaning and
disinfection.
2,3
For cleaning and disinfecting the Meter, see Care,
Cleaning/Disinfecting. For cleaning and disinfecting
the lancing device, see the lancing device’s
Instructions for Use.
We suggest cleaning the Meter when visibly dirty
or if blood is on the Meter. Wash your hands
thoroughly with soap and warm water aer
handling the Meter, lancing device, or Test Strips
as contact with blood presents an infection risk.
Reuse of devices labeled for single-use may result
in product contamination and patient infection.
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5
• DO NOT perform capillary blood glucose
testing on critically ill patients. Capillary blood
glucose levels in critically ill patients with reduced
peripheral blood ow may not reect the true
physiological state. Reduced peripheral blood ow
may result from the following conditions (for
example):
4
~ shock
~ severe hypotension
~ severe dehydration
~ hyperglycaemia with hyperosmolarity,
with or without ketosis.
• Do not use TRUEyou for the diagnosis of
diabetes or for testing blood glucose in neonates
(newborns).
• Do not use TRUEyou System during a xylose
absorption test. is may falsely raise glucose
results.
5
Please check with your Doctor before
using TRUEyou.
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6
TABLE OF CONTENTS
Phone Number, Fast Test Guide,
Expected Results........................................... see covers
Introduction and Important Information ...........1
Know the System ..................................................8
Meter .......................................................................8
Test Strip...............................................................11
Control Solution ..................................................13
Getting Started ....................................................14
Quality Control Testing......................................15
Automatic Self-Test.............................................15
Control Test .........................................................16
How to Test Control Solution ...........................17
Testing Blood ......................................................20
Obtaining a Blood Sample .................................20
How to Test Blood Glucose ...............................22
Unusual Blood Glucose Test Results................25
Ketone Test Alert.................................................26
TRUEyou System and Laboratory Testing......27
Memory................................................................28
View Averages (7-, 14-, and 30-day) ................28
View Results .........................................................29
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7
Meter Set Up........................................................30
Set Ketone Test Alert ..........................................32
Set Testing Reminders ........................................32
Care, Cleaning/Disinfecting ...............................34
Meter Care............................................................34
Control Solution Care.........................................35
Test Strip Care .....................................................35
Changing Battery.................................................36
Troubleshooting..................................................37
Messages................................................................38
Technical Information........................................40
Performance Characteristics..............................40
System Specications ..........................................45
Operating Range..................................................45
Chemical Composition.......................................45
EMC Safety Information.....................................46
Warranty .............................................................47
References............................................................48
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8
KNOW THE SYSTEM
Meter
➀“ + ” Button
Increase numbers in Time/Date Set Up for Meter
and Testing Reminders; turn on Testing Reminders
and Ketone Test Alert; add ALT Symbol; move
forward by date/time when viewing results in
Memory.
➁“ S ” Button
Turn Meter on to view Average values, to view
results in Memory, and to access Meter Set Up.
➂“ - ” Button
Decrease numbers in Time/Date Set Up for Meter
and Testing Reminders; turn o Testing Reminders
and Ketone Test Alert; remove ALT Symbol; move
backward by date/time when viewing results in
Memory.
Top of Meter
1 32
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4
5
Back of Meter
6
➀Display Screen
Shows test results, messages, user prompts, other
information.
➁Test Port
Insert TRUEyou Test Strip here.
➂Strip Release Button
Releases Test Strip aer testing.
➃Battery Door
Use one non-rechargeable 3V lithium battery
(#CR2032), positive (“+”) side up (see Changing
Battery).
➄Meter Label
Contains serial number of Meter. Identies Meter
when calling for assistance.
➅Docking Station Contacts
Contacts used for uploading Meter results to a
computer using a Docking Station (Please call for
availability). 9
2
1
Front of Meter
3
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10
Meter Display
Full Display Screen
1. Memory Symbol
2. Time, Date
3. Result is from 7-, 14-, and 30-day Average
4. Day of Week
5. Test Result
6. Unit of Measure
(Note: Factory set, cannot be changed by user.)
7. Ketone Test Alert Symbol
8. Testing Reminder Symbol
9. Temperature Symbol
10. Drop Symbol - Apply blood or Control Solution
11. Alternate Site (ALT) Symbol
12. Battery Symbol
13. Control Symbol
3
2
1
6
5
4
7
8
9
10
11
12
13
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11
➀Contact End - Insert into Test Port with blocks
(contacts) facing up .
➁Sample Tip - Touch to top of sample (fresh,
capillary or venous blood or Control Solution)
aer inserting Contact End into Meter.
Sample Placement
Correct Incorrect
• Do not touch Sample Tip to drop of sample
unless Contact End is inserted into Meter.
• Do not apply blood or Control Solution to top
of Test Strip.
•Do not smear or scrape drop with Test Strip.
• Do not apply more sample to the Test Strip
aer testing begins.
• Do not insert Sample Tip with sample into
Meter for testing. May damage Meter.
Test Strip
12
Top of Test Strip
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➀Lot Number ( ) - Used for identication
when calling for assistance.
➁ Use By Dates ( ) - Write date rst opened on
vial label. Discard vial and unused Test Strips if
either 4 months aer rst opening or date printed
next to on vial label has passed, whichever
comes rst.
Use of Test Strips or Control Solution past
the Use By Dates may give incorrect test
results. Discard out-of-date products and test
with new products.
➂Control Test Range - Range of numbers in
which Control Test result must fall to assure the
System is working properly.
12
Test Strip Vial Label
1
2
2
3
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13
Control Solution Bottle Label
➀Lot Number ( ) - Used for identication
when calling for assistance.
➁ Use By Dates ( ) - Write date rst opened on
bottle label. Discard bottle if either 3 months
aer rst opening or date printed next to on
bottle label has passed, whichever comes rst.
➂Control Solution Level (1, 2 or 3) - Testing
at least 2 levels of Control Solution is
recommended. Call the number on the cover of
this Booklet for information on how to obtain
dierent levels of Control Solution.
12
3
May 30, 2014
Control Solution
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GETTING STARTED
e TRUEyou Meter comes with pre-set time, date, Ketone
Test Alert and all Testing Reminders o. Before using
Meter for the rst time or aer battery is changed, check
to make sure all of the Meter pre-set functions are correct.
Update any setting as needed (see Meter Set Up).
e Meter turns on when a Test Strip is inserted into the
Test Port or when “ S ” Button is pressed and released (see
Memory and Meter Set Up). Meter turns o when the Test
Strip is released from the Meter, “ S ” Button is pressed and
held for 20 seconds, or aer 2 minutes of non-use.
Always check your supplies before using.
• Check Meter for damage (cracked Display, missing
buttons, etc.). If damage is seen, do not use Meter. Call
for assistance.
• Check Test Strip vial for damage (cracked vial, broken
vial, etc.). Discard damaged vial and all contents (Test
Strips) and use a new vial of Test Strips for testing.
• Write date rst opened on Test Strip vial. Check Use By
Dates (written and printed) before using any Test Strips
from the vial. Do not use if 4months aer rst opening
(written date) or if printed Use By Date has passed.
• Check Control Solution bottle for any leaks or broken
cap. Discard bottle and open a new one for testing.
• Write date rst opened on Control Solution bottle
label. Check Use By Dates (written and printed) before
using. Do not use if 3 months aer rst opening
(written date) or if printed Use By Date has passed.
14
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15
Quality Control Testing
To assure you are getting accurate and reliable results,
TRUEyou oers two kinds of quality control tests.
ese tests let you know that your TRUEyou System is
working properly and your testing technique is good.
Automatic Self-Test
An Automatic Self-Test ensures that
the Meter is working correctly.
1. Wash hands and dry thoroughly.
2. Remove one Test Strip from the
Test Strip vial and insert Test Strip
into the Meter.
3. Meter turns on. e full Display
appears and is replaced by the time
and the blinking Drop Symbol. e
Meter is working correctly and is ready
to perform a Control or blood test.
Do not use Meter if:
• e full Display does not appear
(segments are missing),
• e blinking Drop Symbol does not appear, or
• An error message appears in the Display.
See Troubleshooting or call for assistance (see cover
of this Booklet for phone number).
Full Display
Contacts
Facing Up
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16
Control Test
e Control Test checks that the System is working
correctly and testing technique is good. Use ONLY
TRUEyou Control Solution to perform Control
Tests. Perform Control Tests:
• For practice before using the System for the rst
time,
• When opening a new vial of Test Strips,
• Occasionally as a vial of Test Strips is used,
• If a Test Strip vial has been le opened or le in
extreme heat, cold, or humidity,
• Whenever a check on performance of the System is
needed,
• If results seem unusually high or low,
• If Meter damage is suspected (Meter was dropped,
crushed, wet, etc.).
Performing Control Tests with more than one level
of Control Solution is recommended to ensure that
your System is working properly. ree levels of
TRUEyou Control Solution are available. Contact
place of purchase or use the number on the cover of
this Booklet for more information on how to obtain
dierent levels of Control Solution.
Ranges printed on Test Strip vial label are
for Control Test results only and are not
suggested levels for your blood glucose. Do
not drink Control Solution.
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17
How to Test Control Solution
Use ONLY TRUEyou Control Solution
with the TRUEyou Meter.
1. Check supplies. See Getting Started.
2. Allow Control Solution, vial of Test
Strips and Meter to adjust to room
temperature (20°C-25°C).
Note: Running a Control Test at
temperatures outside the range
listed above may cause Control
Solution to read as a blood test.
3. Wash hands. Dry thoroughly.
4. Gently swirl or invert Control Solution bottle to
mix. DO NOT SHAKE!
5. Remove one Test Strip from vial. Close Test
Strip vial immediately. Use Test Strip quickly
aer removal from vial.
Note: If Test Strip has been out of the
vial too long before testing, an
error message appears upon
insertion of the Test Strip into the
Meter. Release and discard old
Test Strip. Use new Test Strip for
testing.
6. Insert Test Strip into Meter. Meter turns on
and shows blinking Drop Symbol and time. Do
not remove Test Strip.
Contacts
Facing Up
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18
7. With cap removed, turn Control
Solution bottle upside down.
Gently squeeze one drop of Control
Solution onto a clean tissue. Wipe
o bottle tip with the tissue.
Note: If Test Strip is removed before testing
is finished, an error message appears.
Release and discard old Test Strip.
Use new Test Strip for testing.
8. Gently squeeze a drop of Control
Solution onto a small piece of
unused aluminum foil or clear
plastic wrap. Discard foil or plastic
wrap aer use.
Note: Do not put drop on top of the Test
Strip.
9. With Test Strip still in Meter, touch
Sample Tip to top of the drop of
Control Solution. Allow drop to be
drawn into Test Strip. Remove Test
Strip from drop when Meter beeps.
Dashes appear across the Display to
show Meter is testing.
Note: If Meter does not beep or begin testing soon
aer drawing up sample, release and discard
Test Strip. Repeat test with new Test Strip. If
problem persists, see Troubleshooting.
10. Aer testing is nished, the result appears in the
display with the Control Symbol.
LB0010
9 JUNE 2009
Drop Symbol
Meter Testing
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