Electronika AutoSense Voice User manual

1
AutoSense & AutoSense Voice
AutoSense
AutoSense Voice
Blood Glucose Meter
Instrucons for Use
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CONTENTS
READ THIS BEFORE USING THE EQUIPMENT 4
INTRODUCTION 5
CONTENTS OF AUTOSENSE AND AUTOSENSE VOICE KIT 6
AUTOSENSE METER EXPLAINED 7
UNIQUE FEATURE OF AUTOSENSE VOICE 8
FOR USERS OF PLASMA-EQUIVALENT CALIBRATED METERS 9
PRECAUTIONS 11
TECHNICAL DATA 12
PARTS OF THE METER 13
ABOUT THE TEST STRIP 14
Strip insertion and use 16
BEFORE TAKING MEASUREMENTS 17
BLOOD SAMPLING 18
STRIP-AUTOCODING 20
MEASURING WITH THE METER 22
Flagging and marking test results 27
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MEMORY 29
Storing data 29
Recalling data from memory 30
Average calculation 31
OVERVIEW OF FUNCTION MENUS 32
PC mode 32
Setting date and time 33
Alarm settings 35
Switching to speaking function 36
Deleting stored data 37
Selecting unit of measurement 38
Setting hypoglycemic limit 39
BATTERY REPLACEMENT 40
MAINTENANCE 44
AUTOSENSE SYSTEM CHECKING 45
Checking with Check-strip 45
Checking with CareSens control solution 47
ERROR MESSAGES AND TROUBLESHOOTING 49
MANUFACTURER'S WARRANTY 56
SYMBOLS 57
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READ THIS BEFORE USING THE EQUIPMENT
IMPORTANT!
Before testing your blood with your AutoSense or AutoSense Voice Blood
Glucose Monitoring System, please read this user manual carefully.
For safe and easy operation, close study of the Instructions for Use of the meter
and its accessories (lancing device, test strip) is necessary. Should you neglect
to study this manual, you will not be familiar with the proper use of the
equipment.
Always consult your diabetes healthcare professional. This advice applies to all
blood glucose monitoring systems. Always use the equipment only for the
purpose described in this manual.
Do not use accessories that are not supplied or recommended by the
manufacturer or distributor.
Do not use the equipment if it does not function properly.
Ship and store the meter at −20°C to 50°C (−4°F to 122°F).
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AutoSense & AutoSense Voice
INTRODUCTION
Thank you for choosing the AutoSense Blood Glucose Monitoring System. It
has been carefully designed for easy, reliable, and accurate monitoring of your
blood glucose level.
This blood glucose meter meets international standards for the applicable EMC
(Emectromagnetic Compatibility)- emission, electrostatic discharge, and radio
frequency radiation.
This manual is for both AutoSense and AutoSense Voice meters. The only
difference between them is the speaking ability of AutoSense Voice. Therefore,
if not specifically indicated, all instructions are relevant to both meters.
Note:
In this manual, if “AutoSense” is cited, it refers to both AutoSense and
AutoSense Voice meters.
To get the best from your AutoSense meter, please take the time to become
familiar with it.
Please read and understand the instructions in this manual before using your
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meter. Follow the instructions provided in “Maintenance” to prolong the
lifespan and accuracy of your meter.
This manual should tell you everything you need to know about operating your
AutoSense meter; however, it is recommended that you visit a medical doctor
specializing in diabetes treatment if you require more advice.
Keep this manual in a safe place so that you can access and refer to it any time.
Please contact your local distributor if you have any technical questions not
addressed in this manual.
CONTENTS OF AUTOSENSE AND AUTOSENSE VOICE KIT
AutoSense or AutoSense Voice Blood Glucose Meter
Instructions for Use
Illustrated Instructions for Use
Lancing device
Disposable, microbiologically sterile lancets (8 pcs.)
Check-strip (1 pc.)
All parts are microbiologically clean.
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AutoSense & AutoSense Voice
AUTOSENSE METER EXPLAINED
AutoSense indicates blood glucose concentration by checking the reaction
between chemical reagents and the blood drop on the test strip. The reaction
triggers the generation of a current in the test strip’s reagent zone, and this
current is conducted to the meter. The current correlates with the blood
glucose concentration. Therefore, the meter determines blood glucose
concentration by measuring the extent of current flow.
The entire measuring process is controlled by a microprocessor inside the
AutoSense meter.
The microprocessor also controls the internal calibration of the device, and if
any failure is detected during operation, a relevant error message is displayed
(see “Error messages and Troubleshooting”).
AutoSense automatically stores measured data together with the current date
and time. The memory capacity is large enough to store the data from the last
500 tests. The stored data can also be uploaded to a host computer via IR
interface with an additional device: LiteLink (shipped separately upon request).
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UNIQUE FEATURE OF AUTOSENSE VOICE
This feature is a great help for people who may have problems reading
the characters displayed on the screen. By using the speaking function
of AutoSense Voice, the possibility of misreading caused by poor sight
can be reduced significantly.
AutoSense Voice also vocalizes the important instructions and values
displayed on the screen. The clear and simple sentences spoken by the
device make AutoSense Voice an extremely easy-to-use blood glucose
meter. No further explanation of the information vocalized by the
device is required, as it is self-explanatory. Just follow the instructions as
you hear them, and you will use AutoSense Voice without any difficulty.
Audio data is available in 2 languages by default: English and German.
Note:
AutoSense Voice always emits a typical beeping sound when switching
off.
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AutoSense & AutoSense Voice
FOR USERS OF PLASMA- EQUIVALENT
CALIBRATED METERS
This section refers only to users with a plasma-equivalent calibrated meter.
If your meter is plasma-equivalent calibrated, then “Plasma-equivalent
calibrated” is printed on the label on the back of your meter.
Blood glucose measurements can be made either from whole blood or
from plasma (the liquid portion of blood without red blood cells).
Both methods are widely used, although neither is more accurate than the
other is. However, there is a slight difference between the results obtained
from the 2 samples. Plasma measurement values are generally 10%–15%
higher than their whole blood equivalents. Thus, if a plasma result is
221 mg/dl, the whole-blood reading may be within the 190 mg/dl to
200 mg/dl range. Due to the slight difference, the resulting values obtained
from the different methods cannot be compared simply.
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The plasma-calibrated AutoSense meter displays the blood glucose
measurement as obtained from plasma. Therefore, the glucose content
displayed by the meter is the glucose content that would be in the plasma.
Thus, the measurement can be easily compared with the results obtained
from a laboratory that uses plasma for readings.
IMPORTANT!
The plasma-calibrated AutoSense meter uses only whole blood for
reading. To obtain a result for plasma, the plasma-calibrated AutoSense
meter converts the result of the whole-blood measurement to plasma
glucose value.*
* Paul D'Orazio, Robert W. Burnett, Niels Fogh-Andersen: Approved IFCC Recommendation on
Reporting Results for Blood Glucose, IFCC-SD, WG-SEPOCT Document Stage 1, Draft 9, September
2003
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AutoSense & AutoSense Voice
PRECAUTIONS
Always operate your AutoSense Blood Glucose Meter according to the
instructions provided hereafter. If the equipment is used in a manner
not recommended by this manual, the warranty provided by the
manufacturer may be voided.
It is essential to read and follow the information below:
• AutoSense is designed to be used ONLY with an AutoSense Test
strip and no other strips.
• When inserting a new strip, always check if the code on the vial of
strips you are using matches the code that appears on the display.
If it does not, DO NOT use the strip to measure your blood glucose
value (see “Strip Autocoding”).
• Your AutoSense meter is calibrated to be used only with fresh
capillary blood. Venous blood or plasma is not suitable for accurate
monitoring of glucose levels.
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TECHNICAL DATA AutoSense / AutoSense Voice
Batteries: 1 pc. 3 V, type: CR2032/(2 pcs. 3 V, type: CR2032)
Battery life: 1 year or 1500 measurements/(1 year or 1000
measurements)
Calibrated for: AutoSense Test strip
Average test time: 5 seconds
Required sample volume: Min. 0.5 μl capillary blood
Measuring range: 1.1–33.3 mmol/l (20–600 mg/dl)
Display: Below 1.1 mmol/l: Lo, above 33.3 mmol/l: Hi
Memory capacity: Last 500 results with time and date
Strip autocode range: 1–15
Coding system: Autocoding
Automatic switch on: Upon insertion of test strip
Automatic switch off: In 2 minutes after the last button activation
Operating temperature: 10°C–40°C
Relative humidity: <90%
Size: 55 mm × 100 mm × 21 mm
Weight: 60 g/ (90 g) with batterie(s)
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PARTS OF THE METERS
IR data output interface OK (ON/OFF) button Strip ejector button
Strip holder slot SET button Battery holder
Display
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ABOUT THE TEST STRIP
Contact bars Confirmation window
Edge to apply blood sample
Your AutoSense meter is designed ONLY for in vitro use with an
AutoSense Test strip.
Other strips will not provide an accurate result.
When inserting a new strip, always check if the code on the vial of strips
you are using matches the code that appears on the display. The code
does not match that on the vial, DO NOT use the strip to measure your
blood glucose value. If the code numbers do not match, your measured
result will be incorrect (see “Strip Autocoding”).
Each vial of strips is also labeled with an expiry date. Always use the
strips within 3 months from the date of opening and never use the strips
if they have expired.
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Before testing, always ensure that both the meter and the strips are at
room temperature.
Note:
The AutoSense Test strip reacts with blood glucose, generating a
current. The intensity of the current is proportional to the blood glucose
concentration. The AutoSense meter detects the generated microcurrent
and calculates the glucose concentration.
AutoSense Test strips are sensitive to heat and mechanical damage—do
not use the strips if you suspect that such damage may have occurred.
Always keep the strips in their original package, and close the vial each
time after removing a strip.
Do not expose the strips to direct sunlight or store them near any
heating device (radiator, etc.). Unused strips that are stored in the
original capped vial under the circumstances described in this section
will remain stable until the expiration date (indicated on vial label).
The test strips must be shipped and stored at 1°C–30°C (34°F–86°F).
Avoid both freezing and extreme heat.
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IMPORTANT!
• Read the AutoSense Test strip Instructions for Use before using them.
• Always note the date when the vial is first opened, and use the strips
within 3 months from that date.
• Use the removed strip immediately and always close the vial carefully
immediately after removing a strip.
• If the strips are stored below or above room temperature, wait at
least 30 minutes before opening the vial.
Strip insertion and use
The strip must be inserted into the meter’s strip holder with the black side
facing upwards and the square end pointing towards the device. The
meter will switch on automatically upon the insertion of the test strip.
Always ensure that the strip is completely and securely inserted into the
center of the strip holder.
Ensure that enough blood (0.5 μl) is applied to the reagent area located
at the tip of the arrowhead-shaped end of the strip. The reagent window
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at the end of the strip should be filled up completely if a sufficient
amount of blood has been applied (see pictures):
Sufficient amount of blood Insufficient amount of blood
Note: The meter will switch on automatically upon insertion of the test
strip.
BEFORE TAKING MEASUREMENTS
Readings might be affected by:
• Skin contaminants: Always wash and dry your hands thoroughly
before taking your blood sample and using AutoSense meter. Wash
your hands with warm water, as this stimulates blood flow. If you
have difficulties obtaining your blood sample, try dangling your
arm downwards before pricking your finger. This helps to increase
blood flow.
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• Severe dehydration may lead to low measurement values.
• An abnormally high concentration of vitamin C (ascorbic acid) may
lead to high measurement values.
• The hematocrit (red blood cell volume) level in the blood may
influence the measured results. If the hematocrit level is exceeds
55% (>55%), the measurement results may be too low; however, if
the hematocrit level is below 30% (<30%), the meter may display
unusually high results.
• In case of dialysis the hematocrit level may vary. This may
influence the displayed glucose level.
BLOOD SAMPLING
It is recommended to use the lancing device and disposable lancets
packed together with the meter to prick your finger. If you use them,
please read the following instructions:
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• Before using them, wash your hands thoroughly with warm water
and dry them before pricking (thereby stimulating the blood flow).
• Prick the side of your fingertip. However, any other part of your
palm or forearm may be pricked.
• Wipe off the blood that emerges initially after pricking, and then
collect one drop without pressing your finger too hard. Pressing
your finger pad from the lower part upwards will help you to
produce a blood drop.
WARNING!
• Excessive rubbing may influence the measurement results.
• Read the Instructions for Use for the lancing device before using it.
• Dirt or contaminants on the finger or an insufficient amount of
blood may lead to inaccurate results.
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STRIP AUTOCODING
Together, your AutoSense meter and AutoSense Test strip form an
accurate measuring system.
The AutoSense meter has an autocoding system to ensure that the
meter and the strips work together properly. The meter automatically
reads the code on the back of the strip after a strip is inserted (the code
is assigned individually to each vial of strips). Manual coding of the
meter is not needed. When inserting a new strip, always check if the
code on the vial of strips that you are using matches the code that
appears on the display (it influences the accuracy of the meter while it
calculates glucose concentration). The code number can be any number
from 1 to 15. If the code numbers do not match, DO NOT use the strip
to measure your blood glucose value.
In case you have an AutoSense Voice meter, the meter can also read out
the code if the speaking function is switched on.
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