HOMEDIAGNOSTICS TRUE2go User manual

© 2009 Home Diagnostics, Inc. TRUE2go, TRUEtest and the Home Diagnostics logo are trademarks of
Home Diagnostics, Inc.
F4HDI03 Rev. 5
© 2009 Home Diagnostics, Inc. TRUE2go , TRUEtest y el logotipo de Home Diagnostics son marcas comerciales de
Home Diagnostics, Inc.
F4HDI03 Rev. 5
24/7 Customer Consultation
English or Spanish
1-800-803-6025
1-954-677-4599
www.homediagnostics.com
Servicio de consulta de clientes
las 24 horas del día,los 7 dias
de la semana • Inglés o Español
1-800-803-6025
1-954-677-4599
www.homediagnostics.com
Owner’s
Booklet
Libreta
del
propietario
Use only with TRUEtest™
Blood Glucose Test Strips
Usar únicamente con TRUEtest™
Tiras de prueba de glucosa en sangre
Manufactured by:
Fabricado por:

APPLY BLOOD SAMPLE
1 2
Two simple steps
INSERT TEST STRIP
1 2
En dos simples pasos
Guía de prueba rápida
Fast Test Guide
INTRODUZCA LA TIRA
DE PRUEBA
APLIQUE MUESTRA
DE SANGRE
APPLY BLOOD SAMPLE
1 2
INSERT TEST STRIP
Resultados esperados para personas sin diabetes:
Resultado de glucosa en
plasma/sangre1
Antes de comer <100 mg/dL
Dos horas después de las comidas<140 mg/dL
Al acostarse <120 mg/dL
Expected Results for people without diabetes:
Plasma Blood Glucose Result1
Before eating <100 mg/dL
Two hours after meals <140 mg/dL
Bedtime <120 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.
Sólo para referencia rápida. No sustituye a las instruc-
ciones completas. Lea toda la libreta del propietario y las
Instrucciones del producto antes de comenzar la prueba.

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.homediagnostics.com.
Caution! Please read complete Owner’s
Booklet and all product Instructions or Use.
IMPORTANCE OF B OOD G UCOSE
MONITORING
The more you know about diabetes, the better you
will be able to care for yourself. A octor or
iabetes 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 octor or iabetes 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.
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 1

2
FOR PATIENTS
IMPORTANT HEA TH 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.2
Before using the TRUE2go System, check with
your octor 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 octor 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.
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 2

3
FOR HEA THCARE PROFESSIONA S
IMPORTANT HEA TH 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
®
,
S F 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.2False high results may lead
to inappropriate therapy, which may result
in coma or death. For more information:
www.fda.gov/BiologicsBloodVaccines/
SafetyAvailability/ucm154213.htm
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 3

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.
4
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 4

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 E TA
(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. If patient has recently eaten,
fingerstick results from TRUE2go can be up to 70
mg/dL higher than venous laboratory results.3
Inaccurate results may occur in severely
hypotensive individuals or patients in shock.
Inaccurate results may occur for individuals
experiencing a hyperglycemic-hyperosmolar state,
with or without ketosis.
DO NOT test critically ill patients with a blood
glucose meter.4
5
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 5

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 be ore 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. Use the phone number located on the
front cover of this Owner's Booklet for
information on how to obtain different levels
of TRUEtest Glucose Control Solution.
• 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.
6
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 6

7
Phone Number, Fast Test Guide, Expected Results...................
...................................................................................see covers
Introduction and Important Information ..............................1-6
Table of Contents ...................................................................7
Know Your System
Meter ....................................................................................8
Test Strip .............................................................................9
Test Strip Vial Label...........................................................10
Glucose Control Bottle Label ............................................11
Attach/Remove TRUE2go Meter to Test Strip Vial ...........12
Getting Started
Quality Control .............................................................13-14
Control Test ...................................................................15-18
Testing your Blood
Obtaining a Blood Sample............................................19-20
Testing Blood Glucose..................................................21-22
System Out of Range Warning Messages..........................23
Meter Memory
Viewing Results in Memory ..............................................24
Care and Troubleshooting
Caring for TRUE2go.....................................................25-26
Changing Battery ..........................................................27-28
Troubleshooting..................................................................29
isplay Messages ......................................................30-31
Meter Specifications/Chemical Composition.................32
Meter Warranty...............................................................33
References..............................................................................34
Notes ......................................................................................35
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 7

Know Your System
Meter
➀Set Button - Turn Meter on for Memory,
view/scroll results in Memory, mark result as
Alternate Site.
➁Display - Shows results, messages, user prompts,
information.
➂Drop Symbol - Apply blood or Glucose Control.
➃Units of Measure -Note: Factory set, cannot be
changed by user.
➄Strip Release Button - Releases Strip after testing.
➅Test Port - Insert TRUEtest Test Strip here.
➆Meter abel - Contains serial number of Meter and
phone number to call for assistance.
➇Battery Cover - Use one non-rechargeable 3V
lithium battery (#CR2032), positive (“+”) side up
( See Changing Battery).
8
Top of Meter Bottom of Meter
4
6
1
3
2
5
7
8
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 8

9
➀Contact End - Insert into Test Port with blocks
(contacts) facing up .
➁Sample 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 moving across isplay).
• o not smear or scrape drop with Strip.
• o not apply more sample to the Strip after
testing begins.
Note: Do not apply blood or Glucose Control to
top of Test Strip.
Note: Do not insert Sample Tip with sample into
Meter for testing. May damage Meter.
Test Strip
12
Top of Test Strip
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 9

10
Test Strip Vial abel
➀ot Number ( OT) - Used for identification
when calling for assistance.
➁ Expiration Dates (EXP) - Write date first
opened on vial label. iscard 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.
➂Control Range - Range of numbers in which
Control Test result must fall to assure System is
working properly.
1
2
2
3
May 30, 2010
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 10

11
Glucose Control Bottle abel
➀ot Number ( OT) - Used for identification
when calling for assistance.
➁ Expiration Dates (EXP) - Write date first
opened on bottle label. iscard bottle if either 3
months after opening or date printed next to
EXP on bottle label has passed.
➂Control evel (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, 2010
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 11

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.
12
Test Port
Vial Lip
Lift Up To
Open
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 12

13
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.
We recommend performing Control Tests for
practice before using your Meter for the first time to
test your blood. Control Tests should also be
performed:
• Occasionally as you use the vial of Test
Strips,
• When opening a new vial of Strips,
• When Meter results seem unusually low or high, or
• If Meter damage is suspected (Meter was dropped,
crushed, gotten wet, etc.).
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.
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 13

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 isplay appears, then
- the rop Symbol begins to blink.
If an error message appears in the
isplay, 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.
14
rop Symbol
Full isplay
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 14

15
Control Test
Control Tests check that the System is working
properly and your testing technique is good.
Use ON Y TRUEtest Glucose Control to perform
Control Tests.
There are three levels of TRUEtest Glucose Control
Solution available that contain known amounts of
glucose. It is important to perform Control Tests with
more than one level of Control. See front cover for
phone numbers to call for more information on
obtaining different levels of 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.
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:38 AM Page 15

16
How to Test Glucose Control
1. Allow Control, vial of Strips and Meter to adjust to
59-86ºF (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. o not use Control or strips if
Expiration ates 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. 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.
May 30, 2010
Lift Up
To Open
Press own
To Close
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:39 AM Page 16

6. Wait until rop Symbol appears in
isplay. 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.
9. With Strip still in Meter, touch edge
of Sample Tip to drop of Control.
Allow drop to be drawn into Strip.
10. ashes appear across the isplay to
show Meter is testing. Remove Strip
from drop.
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.
17
rop Symbol
Meter Testing
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:39 AM Page 17

18
Test Strip
Vial Label
Glucose Control
Bottle Label
11. Compare result to Control Range
printed on Strip vial label for
Control 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.
Caution! 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 (see front
cover for phone number).
12. After result is shown, turn
Meter so that the Strip is
pointing down. Press Strip
Release button to release and
discard Strip in appropriate
container. Meter turns off.
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.
T2g _OB_GutsENG_F4HDI04.qxd:TT_OB_GutsENG.qxd 1/29/10 10:39 AM Page 18