Nipro TrueResult Twist 2 User manual

1
INTRODUCTION:
Welcome to the TRUEresult twist 2 Blood
Glucose Monitoring System
Our Commitment to You
TRUEresult twist 2 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 products, please see
cover for phone number.
This booklet contains all the information needed to
get the most from the TRUEresult twist 2 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.
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

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 Healthcare Professional will determine target
ranges for blood glucose results and how often 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 TRUEresult twist 2 Blood Glucose
Monitoring System in a manner not specified in
this Owner’s Booklet is not recommended and may
affect your ability to determine true blood glucose
levels.
The TRUEresult twist 2 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. The most accurate results come from
using fresh whole blood taken from the fingertip or
forearm (capillary) or from the vein (venous).

3
What you need to know when using the
TRUEresult twist 2 System:
• Read all product instructions for use before
testing.
• Use only TRUEresult Test Strips and TRUEresult
Control Solution with TRUEresult twist 2 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.

4
IMPORTANT HEALTH and SAFETY
INFORMATION:
The TRUEresult twist 2 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 TRUEresult twist 2
Blood Glucose Monitoring System could carry
blood-borne pathogens after use, even after cleaning
and disinfection.
2,3
For cleaning the Meter, see Care, Cleaning. For
cleaning 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 after
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.

• 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
~ hyperglycaemia with hyperosmolarity,
with or without ketosis.
• Do not use the TRUEresult twist 2 for the
diagnosis of diabetes or for testing blood glucose
in neonates (newborns).
•
Do not use TRUEresult twist 2 System during
a xylose absorption test. This may falsely raise
glucose results.
5
Please check with your Doctor
before using TRUEresult twist 2.
5

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 .................................................................10
Control Solution .....................................................12
Attach/Remove TRUEresult twist 2 Meter to
TRUEresult Test Strip Vial
.....................................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 ...................24
TRUEresult twist 2 System and
Laboratory Testing .................................................25

Time/Date Set Up................................................26
Memory................................................................27
View Averages (7-, 14-, 30-day) ...........................27
View Results ............................................................28
Care, Cleaning.....................................................29
Meter Care ...............................................................29
Control Solution Care............................................30
Test Strip Care.........................................................30
Changing Battery ....................................................31
Troubleshooting..................................................32
Messages...................................................................33
Technical Information........................................35
Performance Characteristics .................................35
System Specifications..........................................39
Operating Range .....................................................39
Chemical Composition ..........................................39
EMC Safety Information .......................................40
References............................................................41
Notes....................................................................42
7

8
KNOW THE SYSTEM
Meter
Display - Shows test results, messages, user
prompts, other information.
Test Port - Insert TRUEresult Test Strip here.
Set Button - Turn Meter on for Memory, view/
scroll results in Memory, mark result as Alternate
Site, set up date/time.
Battery Tray - Holds battery (one non-rechargeable
3V lithium battery #CR2032).
Meter Label - Contains serial number of Meter.
Identifies Meter when calling for assistance.
Micro USB Port - Used with a cable to upload
results to a computer.
Vial Lip Cover - Locks Meter onto a vial of Test
Strips.
Front of Meter Back of Meter
1
2
3
4
6
5
7

Display Screen
Time, Date, Control Symbol (-C-), Alternate Site
Symbol (-A-), Average Symbol (7-, 14-, or 30-day)
Test Result
Memory Result
Battery Symbol
Units of Measure - Factory set, cannot be changed
by user.
Drop Symbol
9
Meter Full Display Screen
1
2
3
4
6
5

10
Contact End - Insert into Test Port with blocks
(contacts) facing up
.
Sample Tip - Touch to top of sample (fresh,
capillary or venous blood or Control Solution)
after 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
after testing begins.
• Do not insert Sample Tip with sample into
Meter for testing. May damage Meter.
Test Strip
12
Top of Test Strip

11
Test Strip Vial Label
Lot Number ( ) - Used for identification
when calling for assistance.

Use By Dates ( ) - Write date first opened on
vial label. Discard vial and unused Test Strips if
either 4 months after opening or date printed
next to on vial label has passed, whichever
comes first.
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.
Control Test Range - Range of numbers in
which Control Test result must fall to assure
System is working properly.
1
2
2
3
May 30, 2014
1
2
2
3
May 30, 2014
or

12
Control Solution Bottle Label
Lot Number ( ) - Used for identification
when calling for assistance.

Use By Dates ( ) - Write date first opened on
bottle label. Discard bottle if either 3 months
after opening or date printed next to on bottle
label has passed, whichever comes first.
Control 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
different levels of Control Solution.
12
3
May 30, 2014
Control Solution

Attach / Remove TRUEresult twist 2 Meter to
TRUEresult Test Strip Vial
The TRUEresult twist 2 Meter is made
to attach to the top of the TRUEresult
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

14
GETTING STARTED
The Meter turns on when a Test Strip is inserted
into the Test Port or when Set Button is pressed and
released (see Memory). Meter turns off when the
Test Strip is released from the Meter, Set Button is
pressed and held for 20 seconds, or after 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 first opened on Test Strip vial. Check
Use By Dates (written and printed) before using
any Test Strips from the vial. Do not use if 4
months after 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 first opened on Control Solution
bottle label. Check Use By Dates (written and
printed) before using. Do not use if 3 months
after opening (written date) or if printed Use By
Date has passed.

Quality Control Testing
To assure you are getting accurate and
reliable results, TRUEresult twist 2 offers
two kinds of quality control tests. These
tests let you know that your TRUEresult
twist 2 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. The full Display
appears and is replaced by the
blinking Drop Symbol. The Meter
is working correctly and is ready to
perform a Control or blood test.
Do not use Meter if:
• The full Display does not appear
(segments are missing),
• The 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).
15
Drop Symbol
Full Display

16
Control Test
The Control Test checks that the System is working
correctly and testing technique is good. Use ONLY
TRUEresult Control Solution to perform Control
Tests. Perform Control Tests:
•
For practice before using the System for the first
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 left opened or left 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
the System is working properly. Three levels of
TRUEresult 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
different 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.

17
How to Test Control Solution
Use ONLY TRUEresult Control Solution
with the TRUEresult twist 2 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 after 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.
Discard old Test Strip. Use new
Test Strip for testing.
6. Insert Test Strip into Meter. Meter
turns on and shows blinking Drop
Symbol. Do not remove Test Strip.
Lift Up
To Open
Press Down
To Close
May 30, 2014
May 30, 2014
Contacts
Face Up

7. With cap removed, turn Control
Solution bottle upside down.
Gently squeeze one drop of Control
Solution onto a clean tissue. Wipe
off bottle tip with the tissue.
Note: If Test Strip is removed before testing
is nished, an error message appears.
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 after 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 dashes appear
across Meter Display. Meter is testing.
Note: If Meter does not begin testing soon after
drawing up sample, discard Test Strip.
Repeat test with new Test Strip. If problem
persists, see Troubleshooting.
10. After testing is finished, the result appears in the
Display.
18
Meter Testing
Drop Symbol

19
11. Compare result to
Control Test Range
printed on Test
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 Test Strip.
If result is still outside range after a second
Control Test, System should not be used for
testing blood. Call for assistance (see cover for
phone number).
12. After result is shown, discard Test
Strip in appropriate container.
Meter turns off. Recap Control
Solution bottle tightly.
Note: Removing Test Strip before result displays cancels
the test. An error message appears and the result
is not stored in Memory. Retest with a new Test
Strip and do not remove before result is displayed.
Test Strip
Vial Label
Control Solution
Bottle Label

20
TESTING BLOOD
Obtaining a Blood Sample
Refer to lancing device’s Instructions for Use for
detailed instructions.
The lancing device is for single patient use ONLY.
For cleaning your lancing device see Lancing Device
Care in the lancing device’s Instructions for Use.
Wash your hands thoroughly with soap and warm
water after handling the Meter, lancing device,
or Test Strips. Contact with blood presents an
infection risk.
•NEVER share lancets or lancing device.
•
Lancets are for single use only. Do not reuse lancets.
• To help prevent false high results, wash hands
before using the System to test blood, especially after
handling fruit or other foods containing sugar.
From Fingertip
1. Prepare fingertip by washing hands in warm,
soapy water. Rinse well. Dry thoroughly.
2. Place end of lancing device
equipped with lancet against tip
of finger. Lance fingertip.
3.
Set lancing device aside. To help blood drop
form, lower hand to waist level, gently massage
finger from palm to fingertip. Allow blood drop
to form before attempting to apply to Test Strip.
4. Recap and remove used lancet from lancing device.
Discard used lancet into appropriate container.
Note: Treat used Test Strips and lancets as a biological risk.
Dispose used Test Strips and lancets in approved container.