NIPRO Diagnostics True2go User manual

© 2011 Nipro Diagnostics, Inc.
TRUE2go, TRUEtest, TRUEresult and the
Nipro Diagnostics logo are trademarks of
Nipro Diagnostics, Inc.
F4NPD03 Rev. 21
24/7 Customer Consultation
English or Spanish
1-800-803-6025
1-954-677-4599
www.niprodiagnostics.com
Owner’s
Booklet
Use only with TRUEtest™
Blood Glucose Test Strips
Manufactured by:
Scan this code with your smart phone
for additional TRUE2go information.
Always refer to the Owner’s Booklet
for detailed product information.
© 2011 Nipro Diagnostics, Inc.
TRUE2go, TRUEtest, TRUEresult y el
logotipo de Nipro Diagnostics son marcas
comerciales de Nipro Diagnostics, Inc.
F4NPD03 Rev. 21
Atención al Cliente
las 24 horas, 7 días a la semana
Inglés o español
1-800-803-6025
1-954-677-4599
www.niprodiagnostics.com
Libreta del
propietario
Usar solo con tiras de prueba
de glucosa en la sangre TRUEtest™
Fabricado por:
Fort Lauderdale, FL 33309 EE. UU.

APPLY BLOOD SAMPLE
1 2
Two simple steps
INSERT TEST STRIP
Fast Test Guide
Expected Results for people without diabetes:
Plasma Blood Glucose Result1
Before eating < 110 mg/dL
Two hours after meals < 140 mg/dL
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.
APLIQUE LA MUESTRA
DE SANGRE
1 2
Dos pasos simples
INSERTE LA TIRA
DE PRUEBA
Resultados esperados para personas sin diabetes:
Resultado de glucosa en plasma/sangre1
Antes de comer < 110 mg/dl
Dos horas después de comer < 140 mg/dl
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.
Guía de prueba rápida

1
INTRODUCTION:
TRUE2go™ Blood Glucose Monitoring System
TRUE2go 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 TRUE2go products,
visit our web site at: www.niprodiagnostics.com.
Caution! Please read complete Owner’s
Booklet and all product Instructions for Use.
Additional 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 on our website www.niprodiagnostics.
com, or call 1-800-803-6049 or 1-954-677-4599.
Importance of Blood Glucose Monitoring
The more you know about diabetes, the better you will be
able to care for yourself. A Doctor or Diabetes Healthcare
Professional will determine how often you should test
and what your target ranges are for blood glucose results.
Having most results within your target ranges shows 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 TRUE2go in a manner not specified in this
Owner’s Booklet is not recommended and may affect the
ability to determine true blood glucose levels.
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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 TRUE2go 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.
2
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3
FOR PATIENTS
IMPORTANT HEALTH and SAFETY
INFORMATION:
• DO NOT use the TRUE2go System to test your blood
glucose if you are undergoing peritoneal dialysis
(dialysis through the abdomen/stomach area).
• DO NOT use the TRUE2go System to test
your blood glucose if you are receiving medical
treatment that contains sugars such as maltose
or xylose (Extraneal®, Icodial®, immunoglobulins
such as Octagam®, or Orencia®).
The treatments listed above may cause false high
glucose results when testing with the TRUE2go
System.4
Before using the TRUE2go System, check with your
Doctor or Healthcare Professional if you think you
may be receiving any of these treatments.
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.
• 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.
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4
FOR HEALTHCARE PROFESSIONALS
IMPORTANT HEALTH AND SAFETY
INFORMATION:
DO NOT use the TRUE2go System for patients
receiving the following treatments:
• Peritoneal dialysis using solutions containing
icodextrin (Extraneal®, Icodial®) that is
metabolized to maltose,
• Injections or infusions of solutions containing
galactose or maltose, including some human
immunoglobulin preparations (Octagam
®
, WinRho
®
,
SDF Liquid, HepaGam B
™
),
• Xylose absorption testing,
• Intravenous solutions containing maltose,
• Any drugs that contain or metabolize to maltose,
galactose, or xylose (Orencia
®
, Adept
®
, Bexxar
®
).
Using the TRUE2go System when receiving
the above treatments may cause false high
glucose results.4False high results may lead
to inappropriate therapy, which may result
in coma or death. For more information see
www.fda.gov/BiologicsBloodVaccines/
SafetyAvailability/ucm154213.htm
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Safe Practices Recommendations for Healthcare
Professionals:
• At patient admission/presentation and
periodically throughout the patient’s stay at the
facility, assess the presence and use of therapies
containing interfering drugs (see previous page).
• Use only laboratory methods for monitoring
blood glucose levels in patients receiving
interfering drugs.
• If there are pre-print order sets for patients
receiving interfering drugs, include a
prescription to test blood glucose using only
laboratory methods.
• Establish facility protocols to verify point-of-care
(bedside) blood glucose results with laboratory
results for patients who are unresponsive or
unable to communicate.
5
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Other Important Information for Healthcare
Professionals
The most accurate results come from using
fresh, capillary whole blood from the fingertip or
forearm. Venous whole blood drawn into EDTA
(purple top tube) or heparin (green top tube) may
be used. Mix tube contents gently before using.
When comparing results between TRUE2go and a
laboratory system, perform a TRUE2go blood test
within 30 minutes of laboratory test. Results from
TRUE2go are considered accurate if within 20%
of laboratory results.5If patient has recently eaten,
fingerstick results from TRUE2go can be up to 70
mg/dL higher than venous laboratory results.6
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):
7
• shock
• severe hypotension
• severe dehydration
• hyperglycemia with hyperosmolarity, with or
without ketosis.
6
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IMPORTANT INFORMATION:
For the most accurate results using TRUE2go:
• Read all instructions before testing.
• TRUE2go is an in vitro (outside body) quantitative
system that is used for self-testing and point-of-
care testing of human whole blood only.
• Meterdisplaysresultsasplasma values.
• Use only TRUEtest™ Test Strips and TRUEtest Glucose
Control with TRUE2go Meter.
• Donotusefordiagnosisofdiabetesorfor
testing blood glucose in newborns.
• PerformControlTestsbefore performing a blood
glucose test for the first time
(see Getting Started).
Note: Three levels of TRUEtest 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.
• WhencarryingyourTRUE2goSystemwithyou,
do not leave it where the storage temperature
printed on vial label may be exceeded (car, trunk,
briefcase, etc).
• RemoveonlyoneStripatatimefromvialwhen
testing. Recap vial immediately after removing
Strip.
7
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8
Phone Number, Fast Test Guide, Expected Results....................
............................................................................................see covers
Introduction and Important Information.............................. 1-7
Table of Contents.......................................................................... 8
Know Your System
Meter............................................................................................ 9
Test Strip ..................................................................................10
Test Strip Vial Label ................................................................11
Glucose Control Bottle Label .................................................12
Attach/Remove TRUE2go Meter to Test Strip Vial ...........13
Getting Started
Quality Control .................................................................. 14-15
Control Test ........................................................................ 16-19
Testing your Blood
Obtaining a Blood Sample................................................ 20-21
Testing Blood Glucose....................................................... 22-23
System Out of Range Warning Messages.............................24
Meter Memory
Viewing Results in Memory ...................................................25
Care, Cleaning/Disinfection and Troubleshooting
Caring for TRUE2go.......................................................... 26-27
Changing Battery................................................................ 28-29
Troubleshooting .......................................................................30
Display Messages............................................................ 31-32
System Specifications/Chemical Composition ........................33
Meter Warranty............................................................................34
References......................................................................................35
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Know Your System
Meter
①Set Button - Turn Meter on for Memory, view/
scroll results in Memory, mark result as Alternate
Site.
②Display - Shows results, messages, user prompts,
information.
③Drop Symbol - Apply blood or Glucose Control.
④Units of Measure - Note: Factory set, cannot be
changed by user.
⑤Strip Release Button - Releases Strip after testing.
⑥Test Port - Insert TRUEtest Test Strip here.
⑦Meter Label - Contains serial number of Meter and
phone number to call for assistance.
⑧Battery Cover - Use one non-rechargeable 3V
lithium battery (#CR2032), positive (“+”) side up
( See Changing Battery).
9
Top of Meter
4
6
1
3
2
5
Bottom of Meter
7
8
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10
①Contact End - Insert into Test Port with blocks
(contacts) facing up .
②Sample Tip - Bring sample (fresh, capillary or
venous blood or Glucose Control) to edge of Tip.
Note: Insert Strip into Meter before touching
Sample Tip to blood or Control drop.
Sample Placement
Correct Placement Incorrect Placement
• Allow sample (blood or Glucose Control drop)
to be drawn into Sample Tip until testing begins
(Dashes move across Display) .
Caution! Holding the Test Strip Sample Tip to the
blood sample too long after the Meter
begins testing may cause inaccurate results.
• Do not smear or scrape drop with Strip.
• Do not apply more sample to the Strip after
testing begins.
Note: Do not apply blood or Glucose Control to top
of Test Strip.
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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11
Test Strip Vial Label
①Lot Number (LOT) - Used for identification
when calling for assistance.
② Expiration Dates (EXP) - Write date first opened
on vial label. Discard vial and unused Strips if
either 4 months after opening or date printed
next to EXP on vial label has passed.
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.
③Control Range - Range of numbers in which
Control Test result must fall to assure System is
working properly.
1
2
2
3
May 30, 2012
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12
Glucose Control Bottle Label
①Lot Number (LOT) - Used for identification
when calling for assistance.
② 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.
③Control Level (1, 2, or 3) - Three levels of
TRUEtest Control are available. We recommend
testing at least 2 levels of Control. Use the
number on the front cover for information on
how to obtain different levels of Control.
12
3
May 30, 2012
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To Attach / Remove TRUE2go Meter to
TRUEtest Test Strip Vial
The TRUE2go Meter is made
to attach to the top of the
TRUEtest Test Strip vial cap.
To attach:
1. Set Test Strip vial on flat
surface with vial lip facing front.
2. With Test Port facing right, place
bottom of Meter firmly on vial
top. Meter must be seated flat on
top of vial cap.
3. Holding the vial, twist the Meter
1/4 turn clockwise. The Test Port
area on the Meter should cover
the vial lip if attached properly.
4. To open the vial, lift up on the
Meter under the Test Port.
To remove:
1. Holding the vial, twist the Meter
1/4 turn counterclockwise.
2. Lift off Meter from vial top.
The Meter may also be used for
testing without attaching to the vial.
13
Lift Up To
Open
Test
Port
Vial Lip
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14
Getting Started
The Meter turns on when a Test Strip is inserted
into the Test Port or when Set Button is pressed (see
Memory). Meter turns off when the Strip is released
or after 2 minutes of non-use.
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Quality Control Testing
To assure you are getting accurate and
reliable results, TRUE2go offers two
kinds of quality control tests. These tests
let you know that your TRUE2go 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 TRUEtest
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 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.
15
Drop Symbol
Full Display
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16
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 opened or exposed to extreme
heat or cold, or humidity,
• If Meter damage is suspected (Meter was dropped,
crushed, wet, etc.)
Note: Three levels of TRUEtest 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! Ranges printed on Strip vial label are
for Control Test results only and are
not suggested levels for your blood
glucose. Do not drink Glucose Control.
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17
How to Test Glucose Control
Use ONLY TRUEtest Glucose Control Solution
with the TRUE2go.
1. Allow Control, vial of Strips and Meter to adjust to
68-77ºF (room temperature). Write date first opened
on Control bottle label and Strip vial label.
Note: Running a Control Test at temperatures
outside the range listed above may cause
Control to read as a blood test.
2. Check dates on Control label and Strip
vial label. Do not use Control or Strips if
Expiration Dates have passed (Control
- 3 months after opening or date next
to EXP on label, Strips - 4 months after
opening or date next to EXP on label).
3. Swirl or invert bottle gently to
mix Control. DO NOT SHAKE!
4. Open vial by pushing up under the
Test Port of the Meter. Remove one Strip
from vial. Close vial immediately by firmly
pressing down on the top of the Meter.
Note: Use Strip quickly after 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 for testing.
May 30, 2012
Lift Up
To Open
Press Down
To Close
Contacts
face up
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6. Wait until Drop Symbol appears in
Display. Keep Strip in Meter until
testing is finished.
Note: If Strip is removed before testing
is finished, an error message
appears. Release and discard old
Strip. Use new Strip for testing.
7. Turn Control bottle upside down.
Squeeze one drop of Control onto
a clean tissue. Wipe off bottle tip.
8. Gently squeeze a Control drop onto
a small piece of unused aluminum
foil or clear plastic wrap. Dispose
after use.
9. With Strip still in Meter, touch edge
of Sample Tip to drop of Control.
Allow drop to be drawn into Strip.
10. Remove Strip from drop. D ashes
appear across the Display to show
Meter is testing.
Note: If Meter does not begin testing
soon after drawing up sample,
release and discard Strip. Repeat
test with new Strip. If problem
persists, see Troubleshooting.
18
LB0010
9 JUNE 2009
Meter Testing
Drop Symbol
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