Accu-Chek Compact Plus User manual

BLOOD GLUCOSE MONITORING SYSTEM
SYSTÈME D’ANALYSE DE LA GLYCÉMIE
User’s Manual
Manuel de l’utilisateur
ACCU-CHEK
®
Compact Plus
Farbe: P 249 – Prüfmittelnummer: 203
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Spot Color:
PMS 249
Process Colors 4c:
Cyan
Magenta
Yellow
Black
ONR 3587 – 4all 4399 – man_06919570001_01_EnCan – 2012
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On the packaging, on the type plate of the meter and on the lancing
device you may encounter the following symbols shown below. They
have the following meanings:
Consult instructions for use
Caution, refer to safety-related notes in the instructions for
use accompanying this product.
Temperature limitation (store at)
Use by
Use only once
Sterilized using irradiation
Manufacturer
Catalogue number
Batch code
In vitro diagnostic medical device
Blood glucose meter: This product fulfils the requirements
of the European Directive 98/79/EC on in vitro diagnostic
medical devices.
Lancing device and lancets: These products fulfil the
requirements of the European Directive 93/42/EEC on
medical devices.
AST cap: This product fulfils the requirements of the
European Directive 93/42/EEC on medical devices.
0088
Farbe: P 249 – Prüfmittelnummer: 203
0088
R
L
I
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3
The explanation of any other symbols can be found in the instructions/
inserts, accompanying components within the packaging.
Keep the blood glucose monitoring system and all its components
away from children under the age of 3. There is a risk of
suffocation if small parts (e.g. covers, caps, or similar objects) are
swallowed.
Last update: 2012-11
This file may not print
or view at 100%.
Die lines and color
breaks do not print.
Spot Color:
PMS 249
Process Color:
Black
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4Intended use
Farbe: P 249 – Prüfmittelnummer: 203
Intended use
Accu-Chek Compact Plus Blood Glucose Meter
Meter for quantitative determination of blood glucose values in fresh
capillary blood using Accu-Chek Compact maltose-independent
chemistry test strips that are labeled with the green symbol N.
Suitable for self-testing.
The Accu-Chek Compact Plus blood glucose meter may be used by
people with diabetes to test their own blood glucose as well as for blood
glucose determination by healthcare practitioners in a professional
setting.
Healthcare professionals must observe additionally the directions
in Chapter 10 “Blood glucose testing in a multi-patient setting –
Information for healthcare professionals”.
Any object coming into contact with human blood is a potential
source of infection (see: Clinical and Laboratory Standards
Institute: Protection of Laboratory Workers from Occupationally
Acquired Infections; Approved Guideline – Third Edition; CLSI
document M29-A3, 2005).
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5
Intended use
Accu-Chek Softclix Plus Lancing Device
Lancing device with adjustable depth setting for obtaining capillary
blood from a fingertip or earlobe using Accu-Chek Softclix lancets and,
when a special AST cap is used, from alternate sites such as the ball of
the thumb.
The lancing device is intended for personal use only!
It may only be used by one and the same person for obtaining
blood. There is a risk of infections being transmitted if the lancing
device is used by other people, or if healthcare professionals use
this lancing device to obtain blood from more than one person,
even family members. This lancing device is therefore not
suitable for professional use in healthcare facilities or institutions.
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6About this User’s Manual
Farbe: P 249 – Prüfmittelnummer: 203
About this User’s Manual
Please read this User’s Manual carefully and completely before testing
blood glucose for the first time. If you have any questions, please call
Accu-Chek Customer Care at 1-800-363-7949 (see Chapter 17).
This User’s Manual will help you get to know your meter and lancing
device step by step. It will provide you with all the information you need
to operate and care for your meter and lancing device and to deal with
any errors that might occur. Remember that, in order to keep your meter
and lancing device in good working condition, you need to follow the
correct operating procedures and also observe certain other
instructions. The meter and lancing device are precision instruments
and improper handling can impair their operation.
This User’s Manual features three symbols to draw your attention to
important information. Please read these points with special care.
This symbol indicates a possible risk of injury or of damage to
your own health or to the health of others.
This symbol draws attention to actions that could result in
damage to the meter or to the lancing device.
i
This symbol draws your attention to important information.
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7
About this User’s Manual
Other symbols are used, too. They have the following meaning:
This symbol is a prompt for you to do something, such as turn the
meter on.
This symbol signifies a list.
This symbol signifies a list within a list.
We recommend that you start by getting to know all of the features of
your meter and lancing device (see Chapter 1.1 and 1.2). Try out all of
the steps described in this manual, and also practice using the meter
and lancing device.
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8Contents
Farbe: P 249 – Prüfmittelnummer: 203
Contents
1 Introduction................................................................................12
1.1 The Accu-Chek Compact Plus blood glucose meter at
a glance..............................................................................12
1.2 The Accu-Chek Softclix Plus lancing device at a glance....... 15
1.3 Main features...................................................................... 16
1.4 Display illustrations.............................................................19
2 Initial steps before testing......................................................... 20
2.1 Checking the contents ........................................................ 20
2.2 Checking the blood glucose unit.......................................... 20
2.2.1 Type plate ...............................................................21
2.2.2 Display check..........................................................21
2.3 Inserting or replacing the test strip drum............................. 24
2.3.1 Test strip drum use-by period..................................33
2.3.2 Indication of the number of test strips remaining.....36
3 Settings ......................................................................................38
3.1 Changing settings – General rules....................................... 41
3.2 Turning the meter on........................................................... 44
3.3 Setting the beep tone or Acoustic Mode ..............................45
3.4 Setting the brightness of the display ...................................48
3.5 Setting the year...................................................................50
3.6 Setting the time/date format ............................................... 52
3.7 Setting the time ..................................................................54
3.8 Setting the date ..................................................................56
3.9 Setting the alarm clock function.......................................... 59
3.10 Setting the hypo indicator ................................................... 67
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9
Contents
4 Testing blood glucose................................................................70
4.1 Preparing to test blood glucose...........................................70
4.2 Preparing the lancing device...............................................70
4.2.1 Undocking the lancing device from the meter..........73
4.2.2 Docking the lancing device onto the meter..............74
4.2.3 Inserting the lancet .................................................75
4.3 Performing a blood glucose test .........................................78
4.3.1 Turning the meter on............................................... 78
4.3.2 Obtaining blood....................................................... 80
4.3.3 Drawing up blood with the test strip........................84
4.4 Ejecting the test strip .......................................................... 90
4.5 Ejecting the used lancet...................................................... 92
4.6 Symbols you see before, during or after testing and
what they mean..................................................................95
4.7 Flagging special results.......................................................96
4.8 Evaluating results................................................................ 97
4.8.1 Measuring range.....................................................98
4.8.2 Implausible results – possible causes of error .........99
5 Using the meter as an electronic notebook............................101
5.1 Memory ............................................................................101
5.2 Retrieving results from memory ........................................ 102
5.3 Average, highest value and lowest value for 7, 14
and 30 days...................................................................... 107
5.4 Downloading test results to a PC, handheld computer
or a special evaluation system .......................................... 114
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10 Contents
Farbe: P 249 – Prüfmittelnummer: 203
6 Acoustic Mode..........................................................................120
6.1 Beep tones at power-on....................................................122
6.2 Beep tones during testing ................................................. 123
6.3 Announcement of the result following a test......................123
6.4 Announcement of results and average values from
memory............................................................................126
6.5 Announcement of warnings and error messages............... 128
7 Checking your meter................................................................ 129
7.1 What you need.................................................................. 130
7.2 Performing a control test ..................................................131
7.3 Possible causes of error during the performance of
control tests...................................................................... 137
8 Cleaning the meter and lancing device...................................140
8.1 Cleaning the meter............................................................140
8.2 Cleaning the lancing device...............................................144
9 Changing the batteries ............................................................145
10 Blood glucose testing in a multi-patient setting –
Information for healthcare professionals ............................... 150
10.1 Replacing the lancing device with a blanking plate............ 152
10.2 Performing a blood glucose test........................................154
10.3 Disinfecting the meter.......................................................158
10.4 Suitable disinfectants........................................................162
11 Measurement and storage conditions .................................... 163
11.1 Temperature and humidity ................................................ 163
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11
Contents
11.2 Light conditions ................................................................165
11.3 Local sources of interference ............................................166
12 Symbols, error messages and troubleshooting......................167
12.1 Symbols shown in the display ........................................... 168
12.1.1 Single symbols......................................................170
12.1.2 Combinations of symbols ......................................176
12.1.3 Symbols appearing in the numeric field.................178
12.2 Interferences and error messages – causes and
troubleshooting recommendations .................................... 181
13 Technical data.......................................................................... 196
14 Alternate site testing ...............................................................200
14.1 The right moment .............................................................202
14.2 Obtaining blood and testing blood glucose ........................ 204
14.3 Cleaning the AST cap........................................................207
15 Disposing of the meter.............................................................208
16 System components ................................................................209
17 Accu-Chek Customer Care ......................................................210
17.1 Advice and troubleshooting...............................................210
17.2 Addresses......................................................................... 211
18 Alphabetical index ...................................................................213
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12 Introduction
Farbe: P 249 – Prüfmittelnummer: 203












1 Introduction
Tip of the test strip – where
blood is drawn up
The meter is supplied with batteries already inserted. The time and date
are already set. You may need to adjust these settings to your own time
zone (see Chapter 3).
1.1 The Accu-Chek Compact Plus blood glucose meter at a
glance
Front
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13
Introduction
1
Display window
S button
Press this button to change settings.
Recess for docking the lancing device
Test button
Use this button only if you want to test your blood glucose or
perform a control test, or wish to turn the meter off. Pull the button
downwards towards the drum compartment cover. The button tips
downwards and the meter turns on. This pull-tip mechanism stops
the meter from turning on inadvertently.
Drum compartment
Drum release button
Test strip guide
Measuring window
Test strip
Test strip drum
Drum compartment cover*
M Button
Press this button to retrieve results stored in the meter’s memory.
* available as replacement part
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14 Introduction
Farbe: P 249 – Prüfmittelnummer: 203








Back
Battery compartment cover*
Infrared window for sending
results to a PC, for instance
Batteries: type AAA, LR 03,
AM 4, Micro
Battery compartment
Type plate
Control window (shows the
number of strips remaining)
Lancing device*
Slide button for undocking the
lancing device
* available as replacement part
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15
Introduction
1
u
v
w
x
y
C
B
A
z
D
1.2 The Accu-Chek Softclix Plus lancing device at a glance
uPlunger
The plunger is a multifunction
button used to prime, trigger
and eject the lancet.
vWindow showing the
penetration depth setting
wLancet holder
xLancet
yProtective cap on lancet
zPin-hole opening for lancet
ACap
BComfort Dial for depth
selection (you change the
depth by rotating the cap)
CLocating notch
DLocating line
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16 Introduction
Farbe: P 249 – Prüfmittelnummer: 203
1.3 Main features
Docked lancing device
The meter comes with an attached Accu-Chek Softclix Plus lancing
device. You can leave it docked onto the meter to collect blood or, if you
prefer, you can undock it.
Test strip drum instead of individual test strips
You never need to touch a test strip. Simply insert a drum with 17 test
strips into the meter.
Luminous display
All information on the display appears in yellow on a black background.
You can adjust the brightness to suit the ambient conditions and make it
easier to read.
Easy to operate
Turn the meter on, apply blood, read the result, press the button to eject
the test strip.
Automatic coding
Every test strip drum has its own bar code. The meter is automatically
coded whenever you insert a new drum, a process which provides the
meter with information on the specific characteristics of the test strips.
Indication of the number of test strips remaining
Each time you turn the meter off, it shows you the number of test strips
remaining in the drum.
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17
Introduction
1
Reliability
The meter checks each test strip. If it finds a defective strip, it lets you
know before you apply blood.
Blood volume checking
The meter can tell when you have applied sufficient blood
(approximately 1.5 µL (1 microlitre = 1 thousandth of a millilitre)). It
waits until then before starting the test. If the test does not start, you
may apply more blood.
Alarm clock function
The meter can remind you to test your blood glucose. You can set an
acoustic signal to remind you at three different times.
Hypo indicator function
In order to look out for unusually low results you can set a hypo
indicator level (hypo threshold). If a result is below the level you have
set, a symbol in the display and an acoustic signal (provided it is set to
on) prompt you to check your result carefully to see if you are heading
towards a possible hypo (low blood glucose).
Downloading data to a computer
The meter has an infrared window. You can download results to a
computer running the appropriate software or to special analysis
systems.
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18 Introduction
Farbe: P 249 – Prüfmittelnummer: 203
Acoustic Mode
When Acoustic Mode is turned on, the meter guides the user through
the blood glucose test using beep tones; it also outputs the result as a
series of beeps. The Acoustic Mode is described in Chapter 6.
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19
Introduction
1
1.4 Display illustrations
Throughout this User’s Manual you will see examples of what the
display looks like. Any elements that are shown surrounded by a halo in
these examples flash in the display.
Example:
You have turned on the meter to perform a blood glucose test. In the
display you see the time and date plus the test strip symbol and the
drop symbol. The test strip symbol and drop symbol are flashing.
The time, date and blood glucose results shown in the display
illustrations are intended only as examples. The numbers will not
necessarily be the same as those shown by your own meter. The meter
that is used for illustration in this manual displays blood glucose results
in mmol/L (see Chapter 2.2) and has been set to 24-hour format (see
Chapter 3.6). Your meter, on the other hand, may display the time in
12-hour format.
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20 Initial steps before testing
Farbe: P 249 – Prüfmittelnummer: 203
2 Initial steps before testing
2.1 Checking the contents
Check that your meter kit is complete. The package contents are listed
on the box.
If anything is missing, please call Accu-Chek Customer Care at
1-800-363-7949. Details are given at the end of this User’s Manual.
2.2 Checking the blood glucose unit
Blood glucose results can be displayed in two different units of
measurement (mmol/L or mg/dL). Consequently, Roche sells two
different versions of the same meter. If you do not know which is the
right unit for you, ask your doctor.
 Check that your meter displays the unit that is right for you, in
Canada mmol/L.
Check the unit by referring to the type plate and to the display window
during a display check (see the following pages).
Note
The unit that your meter displays cannot be changed. If the
wrong unit is printed on the type plate, ask your healthcare
professional to change the meter or contact your Accu-Chek
Customer Care. Using the wrong unit can cause you to
misinterpret the test results.
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