Vertex Diagnostics UltraTRAK Manual de usuario
Ver 1.0
2007 10
UltraTRAKTM
UltraTRAKTM
2
UltraTRAKTM
Dear System Owner:
This manual contains important information that you must know about your
system. Please read it carefully and keep it for future reference.
For other questions regarding this system, please contact your local
customer service. At all other times, you should contact your health care
professional for assistance.
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IMPORTANT SAFETY INSTRUCTIONS
READ THIS BEFORE USING
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near
children, handicapped persons or invalids.
2. Use the device only for the intended use described in this manual.
3. Do not use strips and control solutions which are not supplied by the
manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered
any damage.
5. Before using any product to test your blood glucose, read all instructions
thoroughly and practice the test. Do all quality control checks as directed
and consult with a diabetes healthcare professional.
KEEP THESE INSTRUCTIONS
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UltraTRAKTM
TABLE OF CONTENTS
IMPORTANT SAFETY INSTRUCTIONS 03
IMPORTANT INFORMATION 06
ABOUT ATERNATIVE SITE TESTING (AST) 07
INTRODUCTION OF THE SYSTEM 09
Intended Use 09
Principle of Measurement 09
Contents of the System 10
Appearance and Key Function of the Meter 11
Meter Display Segments 12
Appearance of the Test Strip 13
PREPARATION BEFORE USE 14
Battery Replacement 14
Setting the Meter and Deleting the Memory 16
BEFORE TESTING 20
Checking the Display 20
Coding the Meter 20
Checking the System with Control Solutions 22
Important Control Solution Information 23
Doing a Control Solution Test 24
TESTING YOUR BLOOD 27
Testing Procedure 28
Expected Test Results 34
Special Messages 35
COMPARING METER AND LABORATORY RESULTS 36
USING THE METER MEMORY 38
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Viewing Results on the Meter 38
Viewing Results on a Personal Computer 40
CARING FOR YOUR METER AND STRIP 41
Cleaning 41
Storage 41
PROBLEM-SOLVING GUIDE 44
Error Message 45
Problem in Operation 46
SPECIFICATIONS 48
SUMMARY OF OPERATION 49
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UltraTRAKTM
IMPORTANT INFORMATION
Severe dehydration and excessive water loss may cause false low re-
sults. If you believe you are suffering from severe dehydration, consult a
healthcare professional immediately.
Test results below 60 mg/dL*1(3.3 mmol/L) mean low blood glucose (hy-
poglycemia). Test results greater than 240 mg/dL*2(13.3 mmol/L) mean
high blood glucose (hyperglycemia). If you get results below 60 mg/dL
or above 240 mg/dL, and do not have symptoms, rst repeat the test. If
you have symptoms or continue to get results that fall below 60 mg/dL or
above 240 mg/dL, follow the treatment advice of your healthcare profes-
sional.
Apply only capillary whole blood sample to the absorbent hole. Applying
other substances to the absorbent hole will cause inaccurate results.
If you are experiencing symptoms that are not consistent with your blood
glucose test results and you have followed all instructions described in
this owner’s manual, call your healthcare professional.
Inaccurate results may occur in severely hypotensive individuals or pa-
tients in shock. Inaccurate low results may occur for individuals expe-
riencing a hyperglycemic-hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with blood glucose meters.
Please refer to your test strip package insert for additional important
information.
*1: Kahn, R., and Weir, G.: Joslin’s Diabetes Mellitus, 13th ed. Philadelp
hia: Lea and Febiger (1994), 489.
*2: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea
and Febiger (1989), 261-263.
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ABOUT ALTERNATIVE SITE TESTING (AST)
Important: There are limitations for doing AST.
Please consult your healthcare professional before you do AST.
What is AST?
Alternative site testing (AST) means
that people use parts of the body oth-
er than ngertips to check their blood
glucose levels. This system provides
you to test on the palm, the forearm,
the upper arm, the calf, or the thigh
with the equivalent results to ngertip
testing.
What’s the advantage?
Fingertips feel pain more readily be-
cause they are full of nerve endings
(receptors). At other body sites, since
nerve endings were not so condensed,
you will not feel as much pain as at the
ngertip.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose
levels. Capillary blood at ngertip reects these changes faster than capil-
lary blood at other sites. Therefore when testing blood glucose during or
immediately after meal, physical exercise, or any other event, take blood
sample from your nger only.
We strongly recommend you do AST ONLY in the following intervals:
In a pre-meal or fasting state (more than 2 hours since the last meal).
Two hours or more after taking insulin.
Two hours or more after exercise.
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UltraTRAKTM
Do NOT use AST if:
You think your blood glucose is low.
You are unawareness of hypoglycemia.
Your AST results do not match the way you feel.
You are testing for hyperglycemia.
Your routine glucose results are often uctuating.
You are pregnant.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood ex-
traction has a signicant inuence on the glucose value obtained. Blood
from the site without rubbing exhibits a measurably different glucose con-
centration than blood from the nger. When the puncture site was rubbed
prior to blood extraction, the difference was signicantly reduced.
Please follow suggestions below before getting a drop of
blood:
Rub the puncture site about 20 seconds before penetration.
Use a clear cap (included in the kit) instead while setting the lancing
device.
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INTRODUCTION OF THE SYSTEM
Intended Use
The system is intended for use outside the body (in vitro diagnostic use).
It should be used only for testing glucose (sugar) and only with fresh capil-
lary whole blood samples taken from the nger and the alternative sites
including the palm, the forearm, the upper arm, the calf and the thigh. The
system is intended for use in the home and in clinical settings. It should not
be used for the diagnosis of diabetes or for the testing of newborns.
AST in this system can be used only during steady-state blood glucose
conditions described in the section of “About AST”.
Principle of Measurement
The test is based on the measurement of electrical current generated
by the reaction of glucose with the reagent of the strip. The meter mea-
sures the current and displays the corresponding blood glucose level. The
strength of the current produced by the reaction depends on the amount of
glucose in the blood sample.
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UltraTRAKTM
Contents of the System
The system consists of three main products: the blood glucose meter, test
strips, and two levels of control solution. These products have been de-
signed, tested, and proven to work together as a system to produce ac-
curate blood glucose test results. Use only the same brand-name of test
strips and control solution with the blood glucose meter.
Your system includes:
jA meter Quick Reference Card
kCarrying Case Daily Logbook
lExtra 3V Lithium Battery Warranty card
Owner’s Manaul
Check your system to be sure that it is unopened prior to use
and that it contains all parts listed above. If either of these
conditions occurred, please return your system to the place
of purchase.
There are 3 levels for control solutions: low, normal
and high. Please note that these three levels of control solu-
tion are optional and is not included in the standard kit. Please
ask your local agent for availability.
PLEASE NOTE
UltraTRAKTM
SELF-TEST LOG BOOK
For recording
．
Blood glucose test results
．
Insulin and medication doses
．
Notes
3V
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