Accu-Chek ACTIVE User manual

ACCU-CHEK
®
Active
BLOOD GLUCOSE MONITOR
User’s Manual
0088
0 4493206001(01) 06/04
Roche Diagnostics GmbH
D-68298 Mannheim, Germany
www.accu-chek.com
ACCU-CHEK and SOFTCLIX are trademarks
of a Member of the Roche Group.
Prüfmittel-Nr. 43 IX
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Contents
1 | Introduction 8
|
| 1.1 The monitor’s main features at a glance 9
| 1.2 About this User’s Manual 12
|
2 | Modes 14
|
| 2.1 Test Mode 15
| 2.2 Memory Mode 16
| 2.3 Set Mode 17
|
3 | Initial steps before testing 18
|
| 3.1 After opening the pack 18
| 3.2 Basic settings 19
| Turning the monitor on in Set Mode 23
| Setting the date and time 27
| Setting the beep tone 31
| 3.3 Coding 32
| Inserting the coding chip 35
|
Please read this manual carefully and completely before performing
the first measurement. Should you have any questions, please
contact one of our customer support and service centres. You will
find a list of addresses in Chapter 9.4.
On packaging, on the type plate and in the User’s Manual you may
encounter the following symbols, shown here with their meaning:
For in vitro diagnostic use.
This product fulfils the requirements of Directive
98/79/EC on in vitro diagnostic medical devices.
Catalogue number
Please consult instructions for use
Caution (refer to accompanying documents).
Please refer to safety-related notes in the manual
accompanying this instrument.
Manufacturer
Last update: June 2004
1
IVD
REF
0088
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3
| 6.3 Quality control test procedure 84
| 6.4 Performing a full display check 96
|
7 | Keeping your monitor in tip-top condition 98
|
| 7.1 Cleaning your Accu-Chek Active monitor 99
| Cleaning and disinfection in the professional area 104
| 7.2 Battery life and battery replacement 106
| 7.3 Measurement and storage conditions 109
|
8 | Summary: All the display messages on your
| Accu-Chek Active monitor 112
|
| 8.1 About the display messages 112
| 8.2 Messages and symbols 113
| 8.3 Troubleshooting 117
| 8.4 Possible sources of error 120
|
9 | Appendix 122
|
| 9.1 Technical data 122
| 9.2 System components 124
| 9.3 Guarantee 126
| 9.4 Local customer support and service 127
| 9.5 Addresses 128
|
10 | Alphabetical index 132
4 | Measuring blood glucose with your
| Accu-Chek Active monitor 36
|
| 4.1 Materials for testing blood glucose 36
| 4.2 Preparing for the blood glucose test 37
| 4.3 Testing blood glucose 38
| In-monitor dosing 44
| Plausible results 49
| Implausible results 52
| Out-of-monitor dosing 55
| Testing by healthcare professionals 59
|
5 | Using Accu-Chek Active as an electronic diary 60
|
| 5.1 Results memory 60
| 5.2 Retrieving results 62
| Finding the 7 or 14 day average 67
| Erasing results from memory 71
| 5.3 Downloading data to a PC 74
| General information about data downloading 74
| Downloading procedure 77
|
6 | Checking Accu-Chek Active 80
|
| 6.1 Quality control testing with control solution 80
| 6.2 Preparing for the quality control test 82
Contents Contents
2
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5
1
2
3
4
5
6
7
8
9
Liquid crystal display (LCD)
M(emory) button
S(et) button
Test strip slot with switch
Measurement optics
Test strip guide
Battery compartment
Battery
Coding chip
Parts summary Accu-Chek Active Parts summary Accu-Chek Active
8
7
1
5
4
6
3
2
9
4
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7
Coding chip slot
Infrared interface
10
11
Parts summary Accu-Chek Active Parts summary Accu-Chek Active
11
10
6
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씰Testing in record time: With a testing time of about
5 seconds, your Accu-Chek Active is one of the fastest blood
glucose monitors available.
씰New design: Your new Accu-Chek Active was designed for
ergonomic functionality with good looks.
씰Tiny blood sample: Your Accu-Chek Active requires only a tiny
drop of blood – 1 to 2 µL – if you apply the blood drop to the
middle of the test pad. If at any time the drop you apply is too
small, the monitor will detect this and issue a warning.
씰Easy to operate: No need to press buttons when you carry out
the test.
씰Easy-to-use data analysis function: Accu-Chek Active has a
200-value memory for saving results (together with date and
timestamp) as well as an infrared interface for communicating
with a PC running a suitable analysis program (e.g. Accu-Chek
Compass or Camit software).
Your Accu-Chek Active blood glucose monitor is a state-of-the art
precision instrument that will enable you to test your blood glucose
simply and with confidence.
No matter whether Accu-Chek Active is your first blood glucose
monitor or whether you have already used another type; in your
own interest, please take time to read this manual through carefully
before you attempt to use your monitor.
To use it correctly and dependably, you need to have a thorough
understanding of the way it operates, what the screen displays mean
and what the individual functions are for.
This User’s Manual may tell you a lot of what you know already,
but it will also introduce many features that will be new to you.
At the end of this introduction you will find a brief summary of your
monitor’s main properties and functions. Each of the functions will be
described in more detail later in this manual.
If there are any other points you are unclear about – Chapter 9.4
provides a list of addresses and telephone numbers of our customer
support and service centres.
1 Introduction
9
1.1 The monitor’s main features at a glance
8
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10
씰Easy-to-read display: Numbers and messages are clearly
presented on a spacious display screen. Easily understood
symbols give you additional information and instructions.
씰Intelligent power supply: Accu-Chek Active shuts off automati-
cally after 1–2 minutes of non-use. Naturally, all of your results
and other data remain safe in memory. Also, you receive a
warning when the battery has only enough power for about
another 50 tests.
씰Integrated data evaluation: From the results stored in memory
your monitor can calculate the average of your blood glucose
results over the last 7 or 14 days.
씰Out-of-monitor dosing: After activating the test cycle you may
remove the test strip to apply blood (e.g. from an earlobe),
and then insert it again in the monitor.
씰Accurate results: Application of blood to the test strip starts a
colour reaction. The final colour is accurately read (measured
photometrically) by the monitor’s optical system and the result
is converted to a blood glucose value.
씰Dependable coding: Each pack of test strips contains a coding
chip that holds all of the important information that is needed
to evaluate the strips from that particular pack. Whenever you
open a new pack of strips, simply insert the new coding chip in
the coding chip slot.
1.1 The monitor’s main features at a glance
11
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12
This symbol indicates that your monitor is at risk of being
damaged.
This symbol highlights important information that will help you
get the most out of your monitor.
We recommend that you start by familiarizing yourself with all of
the elements of your Accu-Chek Active shown on pages 4–7 of this
manual. Practise all of the operations described in this manual, and
also practise testing. That way you will always have a dependable
partner to accompany you through the day.
This User’s Manual will help you get to know your new Accu-
Chek Active monitor step by step. It will provide you with all the
information you need to operate, troubleshoot, clean and care for
your monitor. It is important to remember that, in order to keep
your monitor in tip-top condition, you need to comply with the
care instructions in addition to following the correct operating
procedures. Accu-Chek Active is a precision instrument. Dirt or the
wrong cleaning agent (use only cold water or 70% alcohol) can
impair its function.
Please read carefully all text in this manual that is preceded by the
following symbols:
This warns of a situation that may pose a risk to your health
(e.g. as a result of you calculating the wrong insulin dose).
1.2 About this user’s manual
13
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14
This is the main mode in which you will use your Accu-Chek Active
monitor and is used exclusively for testing your blood glucose.
By inserting a test strip in the test strip guide, you automatically
enter this mode.
As you will have gathered, your Accu-Chek Active monitor can do
much more than just measure blood glucose. It offers a number
of additional functions, which fall into three groups. “Mode” refers
to a group of functions that you can call upon. You select a mode
simply by turning on the monitor or by the way in which you turn
it on. Detailed information on the various ways of turning on your
monitor and the options available in each mode is provided later
in this manual.
2 Modes
15
2.1 Test Mode
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16
To enter Set Mode, turn on your Accu-Chek Active
monitor by pressing the S(et) button.
씰You can choose the format in which you wish the date and time
to be displayed.
씰You can enter the date and time (required once only).
씰You can enable and disable the beep tone.
17
2.3 Set Mode
Memory Mode provides you with various functions to help you
evaluate your results. To enter this mode, turn on your Accu-Chek
Active monitor by pressing the M(emory) button.
씰You can retrieve up to 200 results.
씰Your Accu-Chek Active monitor can calculate the average of your
glucose results over the last 7 or 14 days.
씰You can download your results to a PC from the monitor’s
memory (with Accu-Chek Compass or Camit software
– available separately).
씰You can erase the most recent result.
2.2 Memory Mode
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18
When you turn on your Accu-Chek Active monitor for the first time,
it has the following settings (which you can change):
씰Display format for the date: day.month/DD.MM
(or alternatively month.day/MM-DD)
씰Display format for the time: 24h (or alternatively 12h)
씰Year: year of manufacture
씰Date: 0.0 (or alternatively 0-0)
씰Time: 0:00 (or alternatively 0:00 a.m.)
씰Beep tone: on
19
3.2 Basic settings
3.1 After opening the pack
Accu-Chek Active is sold complete with one lithium battery already
inserted. A plastic film protects the battery against becoming
drained prematurely. Before using the monitor, remove the film
covering the battery.
씰The film is visible at the top of your Accu-Chek Active monitor,
projecting from the battery compartment. Simply pull the film
directly away from the top of the monitor.
씰This will open the battery compartment. Then you can remove
the protective film.
씰Slide the battery compartment back into the monitor and press
gently inwards until it clicks into place.
3 Initial steps before testing
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If you see the correct unit, please enter the date and time as
described below. Only then can your results be properly saved
in “memory” with the correct date and timestamp.
21
Accu-Chek Active comes in 2 versions.
When you first turn on your Accu-Chek Active, please be sure to
check that your usual unit (mg/dL or mmol/L) is displayed above
the large numerals in the display (888). Ask your doctor if you
do not know which is the right unit for you. This setting cannot be
changed. If you have a monitor showing the wrong unit, please ask
your dealer for a replacement.
3.2 Basic settings
20
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22 23
Turning the monitor on in Set Mode
You use only the Mand Sbuttons on the front of your Accu-Chek
Active to enter the desired settings.
씰Briefly press the Sbutton (for less than 3 seconds). Accu-Chek
Active is now turned on and in Set Mode.
In the display you see the following:
씰the current time display format (24h/12h)
씰flashing: the current time, or 0:00 (a.m.) when you turn on the
monitor for the first time
씰flashing: the current date, or 0.0 (0-0) when you turn on the
monitor for the first time
23
3.2 Basic settings
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24
The way in which the date and time are displayed from here on
depend on the chosen display format.
씰If you wish to change the time display format, press the M
button now. This allows you to choose between 24h and 12h
display format.
씰When you see the desired format, press the Sbutton once to
proceed to the date and time settings.
25
3.2 Basic settings
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26
Setting the date and time
The procedure for setting the date and time is essentially the same
for all units of time (day, hour, etc.):
씰Use the Sbutton to select the unit of time you wish to change.
The unit will flash, indicating that it is ready to be changed.
씰Use the Mbutton to modify the unit of time selected.
씰Pressing the Mbutton once will increment the value of the unit
by one (one hour, one minute, etc.). Settings where there are
only two options (time format, beep tone) are simply toggled
backwards and forwards when you press the Mbutton.
씰Keeping the Mbutton depressed enables you to fast-scroll the
value forward.
27
3.2 Basic settings
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28
씰Confirm the setting by pressing the Sbutton again. The display
moves on automatically to the next unit of time, which again
flashes.
씰Use the same procedure to set all the remaining units of time.
The date and time are set in the following sequence:
hours –> minutes –> year –> month –> day
The year is already set.
Press the Sbutton to confirm.
The monitor automatically recognises, and allows for, leap years.
29
3.2 Basic settings
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30
Setting the beep tone
After you have set the day and pressed the Sbutton, you can either
enable or disable the beep tone.
씰Press the Mbutton to turn the beep tone on and off.
씰Press the Sbutton to complete the settings procedure.
Check that all the settings now shown on the display are correct.
Press the Sbutton again to turn off your Accu-Chek Active monitor.
If any of the settings are incorrect, you may repeat the settings
procedure (after turning the monitor on again).
31
3.2 Basic settings
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32
Each time you open a new pack of test strips, you will need
to insert the coding chip that came with that pack into your
monitor. Coding chips from other packs contain the wrong
information for your new strips, so test results will be incorrect.
Leave the coding chip in the monitor until you have used up all
of the test strips from a particular pack.
Check that the three-digit code (e.g.133) printed on the chip
matches the code printed on the label of the container the test strips
came in. When coding is complete, your Accu-Chek Active monitor
will display the code number.
33
The properties of the Accu-Chek Active test strips you use with the
monitor may differ very slightly from one pack to another (because
of lot-to-lot differences). Your Accu-Chek Active monitor must be
programmed to allow for these differences in properties in a process
known as “coding”. All the information relating to the strips in a
particular pack of Accu-Chek Active test strips is held in the coding
chip that comes with that pack.
3.3 Coding
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34 35
Inserting the coding chip
When coding, leave your Accu-Chek Active monitor turned off.
씰Take the new coding chip from the pack of test strips.
씰Gently slide the coding chip into the slot on the side of the
monitor ➉(see parts summary).
씰Ensure that you push the coding chip until it clicks into place.
씰That’s all there is to it!
When you subsequently perform your first blood glucose test with
the new coding chip (and new test strips), check that the code
number you see in the display is the same as the number printed on
the container the test strips came in. For further information please
refer to the next chapter.
35
3.3 Coding
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36
If you are not yet familiar with the concept of blood glucose self-
monitoring using a monitor, practise first by carrying out a quality
control test as described in Chapter 6. A quality control test is carried
out in the same way as a normal test, but with control solution
(a standardized glucose solution) instead of blood.
씰Carefully read the pack inserts that came with the test strips
and the lancing device.
씰Thoroughly wash and dry the site you intend to collect blood
from. Any moisture remaining can dilute the blood and so
produce an incorrect result.
씰Remove a test strip from its container. Close the container
immediately. The cap contains a drying agent which ceases to
function if the container is left open, rendering the test strips
unusable.
37
4.2 Preparing for the blood glucose test
4.1 Materials for testing blood glucose
Please have the following items ready to carry out the test:
씰your Accu-Chek Active monitor with the coding chip inserted,
씰the pack of Accu-Chek Active test strips you took the coding
chip from,
씰a suitable lancing system (such as Accu-Chek Softclix and
Accu-Chek Softclix Lancet).
With your Accu-Chek Active monitor use only Accu-Chek
Active test strips. Any other test strips will give incorrect
results. Sometimes the error can be significant, causing the
wrong therapeutic decision to be taken and so producing
adverse health effects!
4 Measuring blood glucose with your
Accu-Chek Active monitor
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