NIPRO Diagnostics TRUEtrack User manual

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© 2014 Nipro Diagnostics, Inc.
TRUEtrack and the Nipro Diagnostics logo
are trademarks of Nipro Diagnostics, Inc.
A4NPD03 Rev. 25
Owner’s
Booklet
Manufactured by:
Fort Lauderdale, FL 33309 U.S.A.
Scan this code with your smart phone
for additional TRUEtrack information.
Always refer to the Owner’s Booklet
for detailed product information.
Atención al cliente las
24 horas, 7 días a la semana
Inglés o español 1-800-803-6025
www.niprodiagnostics.com
© 2014 Nipro Diagnostics, Inc.
TRUEtrack y el logotipo de Nipro Diagnostics
son marcas comerciales de Nipro Diagnostics, Inc.
A4NPD03 Rev. 25
Libreta del
propietario
Fabricado por:
Fort Lauderdale, FL 33309 EE. UU.

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.
APPLY BLOOD SAMPLE
1 2
Twosimple steps
INSERT TEST STRIP
Solo para referencia rápida; no se pretende que sea un
sustituto del instructivo completo. Lea toda la Libreta
del propietario y las Instrucciones para el uso del
producto antes de realizar pruebas.
APLIQUE LA
MUESTRA DE SANGRE
1 2
Dos pasos simples
INSERTE LA
TIRA DE PRUEBA

Welcome to the TRUEtrack®
Blood Glucose Monitoring System
Congratulations on your purchase of the TRUEtrack
Blood Glucose Monitoring System. You now have
a very simple and accurate way to test your blood
glucose (sugar) level, anytime, anywhere.
Our Commitment to You
Our goal is to provide you with quality healthcare
products and dedicated customer service. If you
have questions about using TRUEtrack products,
visit our web site at: www.niprodiagnostics.com.
Instructions for use of the System in a professional
multi-patient setting are included in the Quality
Assurance/Quality Control Manual. The QA/QC
Manual is available, call 1-800-803-6049 or
1-954-677-4599.
CAUTION!
Please read complete Owner’s Booklet and
all product Instructions for Use.
Expected Results for people without diabetes1:
Plasma Blood Glucose Result
Before eating < 100 mg/dL
1

2
Importance of Blood Glucose Monitoring
The more you know about diabetes, the better you will
be able to take care of yourself. A Doctor or Diabetes
Healthcare Professional will determine your target range
for your blood glucose results and how often to test.
Having the majority of your results within your target
range helps slow or stop complications of diabetes.
Having most blood glucose results within your target
range shows how well a treatment plan is working to
control glucose levels. NEVER change your treatment
plan without consulting with your Doctor or Diabetes
Healthcare Professional.
Use of the TRUEtrack in a manner not specified in this
Owner’s Booklet is not recommended and may affect
your ability to determine your blood glucose.

3
FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
WARNING!
NEVER reuse Test Strips. NEVER wipe Test Strips with
water, alcohol or any cleaner. DO NOT attempt to remove
blood or control sample from Test Strips or clean Test Strips
and re-use. Reuse of Test Strips will cause inaccurate results.
• NEVER add a second drop of sample to Strip. Adding
more sample gives an error message.
The TRUEtrack 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
diseases after use, even after 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.
Caution! We suggest cleaning the Meter when visibly dirty.
Wash your hands thoroughly with soap and
warm water after handling the Meter, Lancing
Device, or Test Strips as contact with blood
presents an infection risk.

4
IMPORTANT INFORMATION:
Health Related Information
DO NOT perform capillary blood glucose
testing on critically ill patients. Capillary blood
glucose levels in critically ill patients with reduced
peripheral blood flow may not reflect the true
physiological state. Reduced peripheral blood
flow may result from the following conditions (for
example):4
• shock
• severe hypotension
• severe dehydration
• hyperglycemia with hyperosmolarity, with or
without ketosis.
• Low blood glucose (hypoglycemia) symptoms
may be:
- trembling, sweating, intense hunger,
nervousness, weakness, and trouble speaking.
• High blood glucose (hyperglycemia) symptoms
may be:
- intense thirst, a need to urinate often, a dry
mouth, vomiting, and headache.
If you have any of these symptoms, check your
blood glucose. 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.

5
Important Information
For the most accurate results using TRUEtrack:
• Read all instructions before testing.
• TRUEtrack 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.
• Check Codes. Code in Meter Display must match
Code on vial of TRUEtrack Test Strips being used and
Code Number printed on Code Chip.
• Meter displays results as plasma values.
• Use only TRUEtrack Test Strips and TRUEcontrol®
Glucose Control Solution with TRUEtrack Meter.
• Do not use for diagnosis of diabetes or for testing
blood glucose in newborns.
• The TRUEtrack is recommended for testing of
human capillary whole blood only. TRUEtrack is not
recommended for use with venous samples.
• Perform Quality Control Testing before performing a
blood test for the first time.
Note: Three levels of TRUEcontrol Glucose Control
Solution are available for Quality Control
Testing. We recommend testing at least 2 levels
of Control. Contact place of purchase or call for
assistance to obtain Control.
• Set date and time for correct Morning Average values.
• When using the meter for the first time, check the
unit of measure in the meter Display after performing
a control or blood test. Result must display in the
correct unit of measure (mg/dL).
• If the result does not display in the correct unit of
measure, DO NOT use the meter and DO NOT use
the meter result to determine treatment.

Health Related Information
For Healthcare Professionals:
If comparing results between TRUEtrack and a lab
system, perform a TRUEtrack blood test within 30
minutes of lab test. Results from TRUEtrack are
considered accurate if within +/– 20% of lab results.5
If patient has recently eaten, fingerstick results from
TRUEtrack can be up to 70 mg/dL higher than
venous lab results.6Do not use venous blood with
TRUEtrack.
Instructions for use of the System for more
than one person may be found in the Quality
Assurance/Quality Control Manual. The QA/QC
Manual is available, call 1-800-803-6025 or
1-954-677-4599.
6

Table of Contents
Fast Test Guide............................................... inside front cover
Introductory Information ..................................................... 1-6
Know Your System
Meter .................................................................................. 8-10
Test Strip ...............................................................................11
Test Strip Vial Label .............................................................12
Control Bottle Label.............................................................13
Getting Started
.................................................................................................14
Coding ............................................................................. 15-16
Quality Control Tests...........................................................17
Automatic Self Test...........................................................17
Control Test ................................................................. 18-21
Testing your Blood
How to Obtain a Blood Sample........................................ 22-23
How to Test Blood Glucose............................................... 24-25
System Out of Range Warning Messages..............................26
Set Up (Time, Date).............................................................. 27-28
Memory
Morning Averages (14 and 30 Day).......................................29
Viewing Results in Memory ...................................................30
Care, Cleaning/Disinfection and Troubleshooting
Caring for TRUEtrack ....................................................... 31-32
Changing Battery......................................................................33
Troubleshooting........................................................................34
Display Messages ............................................................ 35-37
System Specifications...................................................................38
Chemical Composition................................................................39
Meter Warranty ............................................................................40
References......................................................................................40
7

Know Your System
Meter
➀Button - Decrease numbers
in Set Up; remove Control Symbol; move
backward by time/date when viewing results in
Memory.
➁Button - Select settings; view Morning
Average values; view results in Memory.
➂Button - Increase numbers in Set Up; add
Control Symbol; move forward by time/date
when viewing results in Memory.
➃Display - Shows test results, messages, user
prompts, and other information.
➄Test Port - Insert TRUEtrack Test Strip here.
8
Top of Meter
1 32
5
4
Front of Meter

➅Data Port - Contact Customer Care at the
number located on cover for more information.
➆Code Chip Port - Insert the Code Chip here.
➇Battery Compartment - Use one
non-rechargeable 3V lithium battery (#CR2032),
positive (“+”) side up.
Note: See Changing Battery for details.
➈Meter Label - Contains telephone number for
assistance.
➉Serial Number Label - Identifies Meter when
calling for assistance.
9
87
69
10
10277
6
Right Side of Meter
Back of Meter
Left Side of Meter

10
Display
1. Time, Date, 14/30 Day Average, Code.
2. Result in Memory.
3. 14- or 30-Day Morning Average.
4. Test result.
5. Battery Symbol (see Display Messages).
6. Temperature Symbol (see Display Messages).
7. Drop Symbol - Apply blood or Glucose
Control.
8. Control Symbol (see Glucose Control Test).
9. Unit of Measure.
Note:
Factory Set. Cannot be changed by user.
10.Time is P.M.
Note:
“AM” does not appear. “PM” is not an option
if factory setting is for 24-hour clock.
3
4
2
1
765
8
9
10

11
Test Strip
1 2
Front of Test Strip
➀ Contact End - Insert into Meter with Contacts
(metallic blocks) facing up before adding sample.
➁Sample Tip - Touch sample (blood or Glucose
Control) to edge of Tip.
Placement of Sample to Test Strip
Correct Incorrect
• Allow sample (blood or Glucose Control
drop) to be drawn into Sample Tip.
Caution! Holding the Test Strip Sample Tip to the
blood sample too long after the Meter
begins testing may cause inaccurate results.
Note: Do not apply blood or Glucose
Control to top of Test Strip.
•
Do not smear or scrape drop with Test Strip .
• Do not apply more sample to Test Strip
after removing from drop.
Note: Do not insert Sample Tip with
sample into Meter for testing.
May damage meter.
Contacts
Face Up

May 30, 2012
1
23
3
4
Test Strip Vial Label
➀Code - Match Code in Meter Display with Code
on Code Chip and Code on Test Strip vial label
before testing. All Codes MUST match for
accurate results.
➁Lot Number (LoT) - Used for identification
when calling for assistance.
➂Expiration Dates (EXP) - Write date first
opened on vial label. Discard vial and unused
Test Strips 120 days after written date or date
printed next to EXP, whichever comes first.
➃Control Range - Range of numbers in which
Control Test result must fall to assure System is
working properly.
Caution! Use of Test Strips or Glucose Control
past the Expiration Dates may give
incorrect test results. Discard out-of
date products and test with new
products.
12

13
Control Bottle Label
➀Lot Number (LoT) - Used for identification
when calling for assistance.
➁ Expiration Dates (EXP) - Write date first opened
on bottle label. Discard bottle if either 3 months
after opening or date printed next to EXP on
bottle label has passed, whichever comes first.
➂Control Level (0, 1, or 2) - Three levels
of TRUEcontrol Control are available. We
recommend testing at least 2 levels of Control.
Use the number on the cover for information on
how to obtain different levels of Control.
12
3
May 30, 2012
Glucose Control

Getting Started
The Meter turns on automatically when a Test
Strip Contact End is inserted into the Test Port or
when is pressed (see Set Up and Memory).
The Meter turns off automatically after the Test
Strip is removed from the Test Port or after 2
minutes of non-use.
Meter comes with pre-set time and date. Before
using the Meter for the first time or after a battery
change, check the time and date and update as
needed (see Set Up).
14

15
Coding
Code Chip is packaged with each box of Test Strips.
Note: After all Test Strips are used from box,
remove Code Chip from Meter and discard.
Open new box of Test Strips and insert new
Code Chip into Meter before testing.
1. Start with Meter off. Remove and
open Code Chip package from box
of Test Strips to be used. Match
Code printed on Code Chip to Code
printed on vial label.
Caution! If Codes do not match, do not use
Test Strips. Call for assistance.
2. If Codes match, insert
Code Chip into Code
Chip Port as shown,
locking in place.
1
0
2
7
1
0
2
7

16
3. Insert Test Strip into Test Port.
Meter turns on. “Code” and number
appear in Display.
4. Match to Code number
on vial label. If Codes
match, begin testing.
Caution! If “Code ----” shows in Display,
reinsert Code Chip and then reinsert
Test Strip. If “Code ----” still shows
in Display or if Codes do not match,
DO NOT use Test Strips. Test results
could be incorrect.
Call for assistance.

17
Quality Control Testing
To assure you are getting accurate and reliable
results, TRUEtrack offers two kinds of quality
control tests. These tests let you know that your
TRUEtrack 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 Test Strip is
inserted correctly into the Test Port.
Insert a Strip into the Test Port.
The Meter is working properly if:
• the full Display appears, then
• the time appears in the upper
part of the Display, and then,
• the Drop Symbol begins to blink
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).
Caution! If any segments are missing in the Display
when Meter is first turned on, do not use the
Meter for testing. Call for assistance.
Full Display

18
Control Test
We recommend performing Control Tests for
practice before using your Meter for the first time
to test your blood.
Control Tests should be performed:
• For practice to ensure your testing technique is good,
• Occasionally as you use the vial of Strips,
• When opening a new vial of Strips,
• If results seem unusually high or low,
• If a vial has been left open or exposed to
extreme heat or cold, or humidity,
• If Meter damage is suspected
(Meter was dropped, crushed, wet, etc.)
Note: Three levels of TRUEcontrol Glucose Control
Solution are available for Quality Control Testing.
It is important to perform Control Tests with more
than one level of Control to assure your System is
working properly and your testing technique is good.
Contact place of purchase or call for assistance to
obtain Control.
Caution! Control 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 Glucose Control.
Only the most current Control Test result is
stored in Memory.