Nipro TrueResult User manual

BLOOD GLUCOSE MONITORING SYSTEM
• PRECISE,
FAST RESULTS
• EASY TO USE
• TINY SAMPLE SIZE
NO
NO
CODING
CODING
Owner’s Booklet
True Performance
E4IAU03FD Rev. 20
BLOOD GLUCOSE MONITORING SYSTEM
NO
NO
CODING
CODING
© 03/2011 Nipro Diagnostics, Inc.
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Owner’s
Booklet
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For assistance, please call 1 800 451 737.
Nipro Australia Pty Ltd.
Suite 3, 500 Pacific Highway
St Leonards, NSW 2065
[email protected]

APPLY BLOOD SAMPLE
1 2
Two simple steps
INSERT TEST STRIP
Fast Test Guide
1
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.
BLOOD GLUCOSE MONITORING SYSTEM
Notes:
The TRUEresult Blood Glucose Monitoring
System is intended for the quantitative
determination of glucose in human whole
blood taken from the finger or forearm
(capillary or venous). The System may not be
used for neonates. The System is intended for
at-home use (self-testing) and for use by
healthcare professionals in both physicians’
offices and in acute and convalescent-care
bedside testing facilities in order to assist in
the management of Type I, Type II, and
gestational diabetes.

INTRODUCTION:
TRUEresult Blood Glucose Monitoring System
TRUEresult 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.
Please read complete Owner’s Booklet and
all product Instructions for Use.
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 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 in a manner not specified in this Owner’s
Booklet is not recommended and may affect ability to determine
true blood glucose levels.
1
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
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2
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.
- Low blood glucose (hypoglycaemia) symptoms
may be trembling, sweating, intense hunger,
nervousness, weakness, and trouble speaking.
- High blood glucose (hyperglycaemia) symptoms
may be intense thirst, a need to urinate often, a dry
mouth, vomiting, and headache.
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Important Information:
The most accurate results come from using fresh,
capillary whole blood from the fingertip 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 and a
laboratory system, perform a TRUEresult blood test
within 30 minutes of laboratory test. Results from the
TRUEresult System are considered accurate if within
20% of laboratory results.1 If the patient has recently
eaten, fingerstick results from the TRUEresult System
can be up to 3.9 mmol/L (70 mg/dL) higher than
venous laboratory results.2
Inaccurate results may occur in severely hypotensive
individuals or patients in shock. Inaccurate results may
occur for individuals experiencing a hyperglycaemic
-hyperosmolar state, with or without ketosis.
DO NOT test critically ill patients with a blood glucose
meter.1
3
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IMPORTANT INFORMATION:
For the most accurate results using TRUEresult:
• Read all instructions before testing.
• TRUEresult 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.
• Meter displays results as Plasma values.
•
Use only TRUEresult Test Strips and TRUEresult
Glucose Control with TRUEresult 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:
Two levels of TRUEresult Glucose 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 different levels of TRUEresult
Glucose Control Solution.
• Remove only one Strip at a time from vial when
testing. Recap vial immediately after removing Strip.
• Do not use TRUEresult System during a xylose
absorption test. Blood Samples containing
xylose concentrations of > 7 mg/dL (0.38
mmol/L) may falsely raise TRUEresult glucose
results. Please check with your Doctor before
using TRUEresult.
4
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5
Phone Number, Fast Test Guide ................................................
...................................................................................see covers
Introduction and Important Information ....................... 1-4
Table of Contents ...................................................................5
Know Your System
Meter ................................................................................ 6-7
Meter Display .......................................................................8
Test Strip .............................................................................9
Test Strip Vial Label ..........................................................10
Glucose Control Bottle Label ............................................11
Getting Started
Quality Control ............................................................. 12-13
Control Test .................................................................. 14-16
Testing your Blood
Obtaining a Blood Sample ........................................... 18-19
Testing Blood Glucose ................................................. 20-21
System Out of Range Warning Messages ..........................22
Meter Set Up
Time and Date .............................................................. 23-24
Alert and Reminders .................................................... 25-27
Memory
Viewing Averages (7, 14 and 30-day) ...............................28
Viewing Results .................................................................29
Care and Troubleshooting
Caring for TRUEresult ................................................. 30-31
Changing Battery.......................................................... 32-33
Troubleshooting .................................................................34
Display Messages ..................................................... 35-36
Performance Characteristics ............................................ 37-42
Meter Specifications/Chemical Composition ........................43
References ..............................................................................44
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6
Know Your System
Meter
➀ “ + ” Button
Increase numbers in Meter Set Up; add ALT
Symbol; move forward by date/time when viewing
results in Memory.
➁ “ S ” Button
Turn Meter on to view Average values, to view
results in Memory, and to access Meter Set Up.
➂ “ - ” Button
Decrease numbers in Meter Set Up; remove ALT
Symbol; move backward by date/time when
viewing results in Memory.
Top of Meter
1 32
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➀ Display Screen
Shows results, messages, user prompts, information.
➁ Test Port
Insert TRUEresult Test Strip here.
➂ Strip Release Button
Releases Strip after testing.
➃ Battery Door
Use one non-rechargeable 3V lithium battery
(#CR2032), positive (“+”) side up (see Changing
Battery).
➄ Meter Label
Contains serial number of Meter.
7
4
5
Back of Meter
2
1
Front of Meter
3
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8
Full Display Screen
1. Result is from Memory
2. Time, Date
3. Time is AM/PM
4.
Result is from 7, 14, or 30 day Average
5. Day of Week
6. Test Result
7. Units of Measure (Note: Factory set, cannot be
changed by user.)
8. Ketone Test Alert
9.
Testing Reminder
10. Temperature Symbol
11. Drop Symbol - Apply blood or Glucose
Control
12. Alternate Site (ALT) Symbol
13. Battery Symbol
14. Control Symbol
3
4
2
1
7
6
5
8
9
10
11
12
13
14
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➀ Contact End - Insert into Test Port with blocks
(contacts) facing up .
➁ Sample 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 Display).
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.
Note: 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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➀ Lot Number ( ) - Used for identification
when calling for assistance.
➁ Expiry Dates ( ) - Write date first opened on
vial label. Discard vial and unused Strips if either
4 months after opening or date printed next to
on vial label has passed.
Use of Test Strips or Glucose Control past
the Expiry Dates may give incorrect test
results. Discard out-of-date products and
test with new products.
➂ Control Range - Range of numbers in which
Control Test results must fall to assure the
System is working properly.
10
Test Strip Vial Label
1
2
2
3
May 30, 2012
1
2
2
3
May 30, 2012
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11
Glucose Control Bottle Label
➀ Lot Number ( ) - Used for identification
when calling for assistance.
➁ Expiry 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.
➂ Control Level (1 or 2) - Two levels of
TRUEresult 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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Getting Started
The Meter turns on when a Test Strip is inserted
into the Test Port or when “ S ” Button is pressed
(see Memory and Meter Set Up). Meter turns off
when the Strip is released from the Meter or after 2
minutes of non-use.
Meter comes with pre-set time, date and all testing
Alerts and Reminders off. Before using the Meter
for the first time or after a battery change, check
the time, date, Alerts and Reminders, and update as
needed (see Meter Set Up).
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, TRUEresult offers three kinds of quality
control tests. These tests let you know that your
TRUEresult System is working properly and your
testing technique is good.
12
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13
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. 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).
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
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14
Control Test
Control Tests check that the System is working
properly and your testing technique is good.
Use ONLY TRUEresult Glucose Control to perform
Control Tests.
There are two levels of TRUEresult 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.
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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15
How to Test Glucose Control
1. Allow Control, vial of Strips and Meter to adjust to
15-30ºC (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 Expiry Dates have passed.
(Control - 3 months after opening
or date next to on label; Strips - 4
months after opening or date next to
on labels.) Discard expired products and
use new products.
3. Swirl or invert bottle gently to mix Control.
DO NOT SHAKE!
4. Remove one Strip from vial. Close Strip vial
immediately.
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
May 30, 2012
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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.
Remove Strip from drop when
Meter beeps.
10. Dashes appear across the Display to
show Meter is testing.
Note: If Meter does not beep or begin
testing soon after drawing up
sample, release and discard
Strip. Repeat test with new
Strip. If problem persists, see
Troubleshooting.
LB0010
9 JUNE 2009
Drop Symbol
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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.
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 (see front cover for phone number).
12. After result is shown, Strip Release
Button flashes. Hold Meter with Test
Strip 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.
Control Symbol
Test Strip
Vial Label
Glucose Control
Bottle Label
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18
Obtaining a Blood Sample
Refer to Lancing Device
“Instructions for Use” for detailed instructions.
• Never share a lancet or lancing device.
• Lancets are for single use only.
Do not reuse lancets.
From Fingertip
1. Prepare fingertip by washing hands in warm,
soapy water. Rinse well. Dry thoroughly.
2. Place end of Lancing Device
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.
Always remove and discard used Lancet in
appropriate container when testing is complete.
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