Nipro TRUEresult mini User manual

Owner’s Booklet
BLOOD GLUCOSE MONITORING SYSTEM
EASY TO USE
TINY SAMPLE SIZE
FAST RESULTS
NO
CODING
CODING
NO
CODING
NO
CODING

APPLY BLOOD SAMPLE
1 2
Two simple steps
INSERT TEST STRIP
Fast Test Guide
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 diabetes:1
Plasma Blood Glucose Result
Before eating < 6.1 mmol/L
Two hours
after meals < 7.8 mmol/L
BLOOD GLUCOSE MONITORING SYSTEM

1
INTRODUCTION:
TRUEresult mini Blood Glucose Monitoring System
TRUEresult mini 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 TRUEresult mini
products, please see cover for phone number.
Please read complete Owner’s Booklet and
all product Instructions for Use.
IMPORTANCE OF BLOOD GLUCOSE MONITORING
e more you know about diabetes, the better you
will be able to care for yourself. A Doctor or Diabetes
Healthcare Professional will determine how oen you
should test and what your target ranges are for blood
glucose results. Having most results within your target
ranges show how well a treatment plan is working to
control glucose levels. Keeping results within your
target ranges helps slow or stop complications from
diabetes.
NEVER change your treatment plan without consulting
a Doctor or Diabetes Healthcare Professional.
Use of TRUEresult mini in a manner not specied in
this Owner’s Booklet is not recommended and may
aect ability to determine true blood glucose levels.
For
Assistance
Call
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

2
FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
WARNING!
r NEVER reuse Test Strips. NEVER wipe Test
Strips with water, alcohol or any cleaner. DO NOT
attempt to remove blood or Control Solution sample
from Test Strips or clean Test Strips and re-use.
Reuse of Test Strips will cause inaccurate results.
r NEVER add a second drop of sample to Strip.
Adding more sample gives an error message.
e TRUEresult mini 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 your Blood
Glucose Monitoring System could carry blood-
borne pathogens aer use, even aer cleaning and
disinfection.
2,3
For cleaning and disinfecting your Meter, see
Meter Care, Cleaning/Disinfection. For cleaning
and disinfecting your Lancing Device see the
Instructions for Use.
We suggest cleaning the Meter when visibly
dirty. 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.

3
FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
If you have symptoms of low or high blood glucose,
check your blood glucose immediately. If your result
does not match the way you feel, repeat the test. If
your results still do not match the way you feel, call
your Doctor or Healthcare Professional.
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may be: - trembling, sweating, intense hunger,
nervousness, weakness, and trouble speaking.
r )JHICMPPEHMVDPTF)ZQFSHMZDBFNJBTZNQUPNT
may be: - intense thirst, a need to urinate oen, a
dry mouth, vomiting, and headache.

Other Important Information for Healthcare
Professionals:
e most accurate results come from using fresh, capillary
whole blood from the ngertip or forearm. Venous
whole blood collected into sodium or lithium heparin
vacutainer tubes may be used for testing by healthcare
professionals. Use of EDTA vacutainer tubes (purple top)
is not recommended and may cause low results. Mix tube
contents gently before using.
When comparing results between TRUEresult mini and
a laboratory system, perform a TRUEresult mini blood
test within 30 minutes of laboratory test. Diabetes experts
have suggested that glucose meters should agree within
0.83 mmol/L of a laboratory method when the glucose
concentration is less than 4.2 mmol/L, and within 20%
of a laboratory method when the glucose concentration is
4.2 mmol/L or higher.
4
If patient has recently eaten,
ngerstick results from TRUEresult mini can be up to
3.9 mmol/L higher than venous laboratory results.
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):
6
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with or without ketosis
4

5
IMPORTANT INFORMATION:
For the most accurate results using TRUEresult mini:
r Read all instructions before testing.
t TRUEresult mini is an in vitro (outside body) quantitative system
that is used for self-testing and point-of-care (bedside) testing of
human whole blood only.
t .FUFSEJTQMBZTSFTVMUTBTPlasma values.
t 6TFPOMZ536&SFTVMUTest Strips and TRUEresult Control
Solution with TRUEresult mini Meter.
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in newborns.
t 1FSGPSN$POUSPM5FTUTbefore performing a blood glucose test for
the rst time (see Getting Started).
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leave it where the storage temperature printed on vial label may be
exceeded (car, boot, briefcase, etc).
Note: ree levels of TRUEresult Control Solution are available for
Quality Control Testing. Call for availability using the number
located on the cover of this Owner’s Booklet for information on
obtaining dierent levels of TRUEresult Control Solution.
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vial immediately aer removing Strip.
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test. is may falsely raise TRUEresult glucose results. Please
check with your Doctor before using TRUEresult mini.
7
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cause elevated meter glucose results.
7
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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 your Blood Glucose
Monitoring System could carry blood-borne pathogens aer use,
even aer cleaning and disinfection.
2

6
Phone Number, Expected Results, Fast Test Guide....................
............................................................................................see covers
Introduction and Important Information.............................. 1-5
Table of Contents.......................................................................... 6
Know Your System
Meter........................................................................................ 7-9
Test Strip ..................................................................................10
Test Strip Vial Label ................................................................11
Control Solution Bottle Label.................................................12
Getting Started..........................................................................13
Quality Control Testing .................................................... 14-15
How to Test Control Solution.......................................... 16-18
Testing your Blood
Obtaining a Blood Sample................................................ 19-20
How to Test Blood Glucose.............................................. 21-22
System Out of Range Warning Messages.............................23
Time and Date Set-up........................................................ 24-25
Meter Memory
Viewing Averages.....................................................................26
Viewing Results ........................................................................27
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Caring for TRUEresult mini............................................. 28-29
Changing Battery................................................................ 30-31
Troubleshooting .......................................................................32
Display Messages............................................................ 33-34
Performance Characteristics................................................. 35-40
System Specications/Chemical Composition ........................41
System Safety Information..........................................................42
References......................................................................................43
Notes ..............................................................................................44

7
Know Your System
Meter
{“ V” Button
Increase numbers in Time/Date Set Up;
add ALT Symbol; move forward by date/time when
viewing results in Memory.
|“ O” Button
Turn Meter on to view Average values; to view
results in Memory and to access Time/Date Set Up.
}“ W” Button
Decrease numbers in Meter Set Up;
remove ALT Symbol; move backward by date/time
when viewing results in Memory.
~Display Screen
Shows results, messages, user prompts, information.
Test Port
Insert TRUEresult Test Strip here.
Strip Release Button
Press to release Strip aer testing.
Top
1
3
4
5
6

Bottom
Le Right

{Battery Tray
Gently pull to slide open Battery Tray.
Use one non-rechargeable 3V lithium battery
(#CR2032), positive (“+”) side up
(see Changing Battery).
|Meter Label
Contains Serial Number of Meter.
8
Back of Meter
1
Closed
Open


9
Full Display Screen
1. Result is from Memory
2. Low Battery Symbol
3. Test Result
4. Time, Date
5. Time is AM/PM
6. Units of Measure
(Note: Factory set, cannot be changed by user.)
7.
Result is from 7, 14 or 30 day Average
8. Control Symbol
9. Alternate Site (ALT) Symbol
10. Drop Symbol - Apply Blood or Control
Solution sample
34

1
7
6
5

9

Top
Bottom
Le Right

10
Contact End - Insert into Test Port with blocks
(contacts) facing up .
Sample Tip - Bring sample (fresh capillary or
venous blood or Control Solution) to edge of Tip.
Note: Insert Strip into Meter before touching
Sample Tip to blood or Control Solution drop.
Sample Placement
Correct Placement Incorrect Placement
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to be drawn into Sample Tip until testing
begins (dashes moving across Display).
Holding the Test Strip Sample Tip to the
blood sample too long aer the Meter begins
testing may cause inaccurate results.
rDo not smear or scrape drop with Strip.
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testing begins.
Note: Do not apply blood or Control Solution to
top of Test Strip.
Do not insert Sample Tip with sample into
Meter for testing. May damage Meter.
Test Strip
1
Top of Test Strip

11
Test Strip Vial Label
Lot Number ( ) - Used for identication
when calling for assistance.
 Use By Date ( ) - Write date rst opened on
vial label. Discard vial and unused Strips if either
4 months aer opening or date printed next to
on vial label has passed.
Use of Test Strips or Control Solution past the Use
By Date may give incorrect test results. Discard
out-of-date products and test with new products.
Control Solution Range - Range of numbers
in which Control Test result must fall to assure
System is working properly.
1


3
May 30, 2013

12
Control Solution Bottle Label
Lot Number ( ) - Used for identication
when calling for assistance.
 Use By Date ( ) - Write date rst opened on
bottle label. Discard bottle if either 3 months
aer opening or date printed next to on bottle
label has passed.
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of TRUEresult Control Solution are available.
We recommend testing at least 2 levels of
Control Solution. Use the number on the front
cover for information on how to obtain dierent
levels of Control Solution.
1
3
May 30, 2013

Getting Started
e Meter turns on when a Test Strip is inserted into
the Test Port or when “
O ” Button is pressed (see
Memory and Time and Date Set Up). Meter turns o
when the Strip is released from the Meter or aer
two minutes of non-use.
Meter comes with pre-set time and date. Before
using the Meter for the rst time or aer a battery
change, check the time and date. Update as needed
(see Time and Date Set Up).
13

14
Quality Control Testing
To assure you are getting accurate and reliable
results, TRUEresult mini oers two kinds of quality
control tests. ese tests let you know that your
TRUEresult mini System is working properly and
your testing technique is good.
Automatic Self-Test
An Automatic Self-Test is
performed by the Meter each time
a TRUEresult Test Strip is inserted
correctly into the Test Port.
Insert a Strip into the Test Port.
e Meter is working properly if:
- the full Display appears, then
- the time appears in the upper
right of the Display, and then
- the Drop Symbol begins to blink
in the le side of Display.
If an error message appears in the Display, the
Meter will not perform a test. See Troubleshooting
or call for assistance (see cover for phone number).
If any segments are missing in the
Display when Meter is rst turned on,
do not use the Meter for testing. Call for
assistance.

15
Control Test
We recommend performing Control Tests for
practice before using your Meter for the rst time
to test your blood. Control Tests should also be
performed:
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heat or cold, or humidity,
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gotten wet, crushed, etc.).
Control Tests check that the System is working
properly and your testing technique is good.
Use ONLY TRUEresult Control Solution to
perform Control Tests.
ere are three levels of TRUEresult Control Solution
available that contain known amounts of glucose.
It is important to perform Control Tests with more
than one level of Control Solution. See front cover
for phone numbers to call for more information on
obtaining dierent levels of Control Solution.
Ranges printed on Strip vial label are
for Control Test results only and are
not suggested levels for your blood
glucose. Do not drink Control Solution.

16
How to Test Control Solution
1. Allow Control Solution, vial of Strips
and Meter to adjust to 20°C-25°C
(room temperature). Write date rst
opened on Control Solution bottle
label and Strip vial label.
Note: Running a Control Test at temperatures
outside the range listed above may cause
Control Solution to read as a blood test.
 Check dates on Control Solution label and Strip
vial label. Do not use Control Solution or strips
if Use By Date have passed (Control Solution
- 3 months aer opening or date next to on
label, Strips - 4 months aer opening or date
next to on label). Discard expired products
and use new products.
3. Swirl or invert bottle gently to mix Control
Solution. DO NOT SHAKE!
4. Remove one Strip from vial. Close Strip vial
immediately.
Note: Use Strip quickly aer removal from vial.
5. Insert Strip into Test Port. Meter turns on.
Note: If Strip has been out of the vial
too long before testing, an error
message appears upon insertion
of the Strip into the Meter.
Release and discard old Strip.
Use new Strip.
May 30, 2013
Contacts
face up

17
6. Wait until Drop Symbol appears
in Display. Keep Strip in Meter
until testing is nished.
Note: If Strip is removed before
testing is nished, an error
message appears. Release and
discard old Strip. Use new
Strip for testing.
7. Turn Control Solution bottle
upside down. Squeeze one drop
of Control Solution onto a clean
tissue. Wipe o bottle tip.
 Gently squeeze a Control
Solution drop onto a small piece
of unused aluminum foil or clear
plastic wrap. Dispose aer use.
9. With Strip still in Meter, touch
edge of Sample Tip to drop of
Control Solution. Allow drop to
be drawn into Strip.
 Dashes appear across the
Display to show Meter is testing.
Note: If Meter does not begin
testing soon aer drawing up
sample, release and discard
Strip. Repeat test with new
Strip. If problem persists, see
Troubleshooting.
Apply Sample
Meter Testing

18
11. Compare result to Control
Solution Range printed on
Strip vial label for Control
Solution Level you are using.
If result is in range,
System can be used
for testing blood. If
result does not fall
within range, repeat
test using a new Strip.
Note: Control Test result shows the Control Symbol in
the Display.
If Control Test result is outside range, test again.
If result is still outside range, System should not
be used for testing blood. Call for assistance.
 Aer result is shown, hold Meter with
Test Strip pointing down. Press Strip
Release Button to release and discard
Strip in appropriate container. Meter
turns o.
Note: Removing Strip before result
displays cancels the test. An error
message appears and the result is not stored in
Memory. Retest with a new Strip and do not
remove before result is displayed.
Test Strip
Vial Label
Control Solution
Bottle Label