Accu-Chek Compact Plus User manual

BLOOD GLUCOSE MONITORING SYSTEM
Reference Manual
AA
CCU-
CCU-C
HEK
HEK
®
Compact Plus
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On the packaging, on the type plate of the meter and on the finger
pricker you may encounter the following symbols shown below. They
have the following meanings:
Consult instructions for use
Caution (refer to accompanying documents). Please refer to
safety-related notes in the instructions for use accompany-
ing this instrument.
Store at
Use by / Expiry date
For single use only
Sterilized through irradiation
Manufacturer
Catalogue number
Lot number
For in vitro diagnostic use
Blood glucose meter: This product fulfils the requirements
of Directive 98/79/EC on in vitro diagnostic medical
devices.
Finger pricker and lancets: These products fulfil the
requirements of Directive 93/42/EEC on medical devices.
IVD
0088
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3
The explanation of any other symbols can be found in the instructions/
inserts, accompanying components within the packaging.
Last update: 2007-03
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4Intended use
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 test strips.
Suitable for self-testing.
The meter may be used by people with diabetes to test their own blood
glucose as well as for blood glucose determination by healthcare practi-
tioners 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”.
The Accu-Chek Softclix Plus finger pricker is intended for patient
self-monitoring by a single person.
It must not be used to collect blood in a multi-patient setting as it
does not incorporate any features to guard against cross-infec-
tion.
Any object coming into contact with human blood is a potential
source of infection (see: Clinical and Laboratory Standards Insti-
tute: 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 Finger pricker
Finger pricker with adjustable depth setting for obtaining capillary blood
from a fingertip or earlobe and, when a special AST cap is used, from
alternative sites such as the ball of the thumb.
The Accu-Chek Softclix Plus finger pricker is intended only for
patient self-monitoring by a single person. It must not be used
to collect blood in a multi-patient setting as it does not
incorporate any features to guard against cross-infections.
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6About this Reference Manual
About this Reference Manual
Please read this Reference Manual carefully and completely before
testing blood glucose for the first time. If you have any questions, please
contact your local customer support and service centre (see Chapter
17).
This Reference Manual will help you get to know your meter and finger
pricker step by step. It will provide you with all the information you need
to operate and care for your meter and finger pricker and to deal with
any errors that might occur. Remember that, in order to keep your meter
and finger pricker in good working condition, you need to follow the cor-
rect operating procedures and also observe certain other instructions.
The meter and finger pricker are precision instruments and improper
handling can impair their operation.
Should you have any questions, please call the Accu-Chek Customer
Careline free on 0800 701000 (UK) or 1800 709600 (Ireland).
This Reference 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 dam-
age to meter or to the finger pricker.
iThis symbol draws your attention to important information.
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7
About this Reference 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.
앫This symbol signifies a list.
쐍This symbol signifies a list within a list.
We recommend that you start by getting to know all of the features of
your meter and finger pricker (see Chapter 1.1 and 1.2). Try out all of
the steps described in this manual, and also practise using the meter
and finger pricker.
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8Contents
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 finger pricker 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 finger pricker ................................................ 70
4.2.1 Undocking the finger pricker from the meter ........... 73
4.2.2 Docking the finger pricker onto the meter ............... 74
4.2.3 Inserting the lancet ................................................. 75
4.3 Testing blood glucose.......................................................... 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
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 performance check ...................................... 131
7.3 Possible causes of error during the performance of
performance checks ......................................................... 137
8 Cleaning the meter and finger pricker.................................... 140
8.1 Cleaning the meter............................................................ 140
8.2 Cleaning the finger pricker................................................ 144
9 Changing the batteries ............................................................ 145
10 Blood glucose testing in a multi-patient setting –
Information for healthcare professionals ............................... 150
10.1 Replacing the finger pricker with a blanking plate ............. 152
10.2 Testing blood glucose........................................................ 154
10.3 Disinfecting the meter....................................................... 158
10.4 Suitable disinfectants........................................................ 162
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11
Contents
11 Measurement and storage conditions .................................... 163
11.1 Temperature range ........................................................... 163
11.2 Light conditions ................................................................ 165
11.3 Humidity ........................................................................... 166
11.4 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................. 179
12.2 Interferences and error messages – causes and
troubleshooting recommendations .................................... 181
13 Technical data.......................................................................... 196
14 Disposing of the meter ............................................................ 200
15 System components ................................................................ 201
16 Patents...................................................................................... 202
17 Local customer support and service....................................... 203
17.1 Advice and troubleshooting ............................................... 203
17.2 Addresses......................................................................... 204
18 Alphabetical index ................................................................... 205
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12 Introduction












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 finger pricker
Test button
Use this button only if you want to test your blood glucose or per-
form a performance check, or wish to turn the meter off. Pull the
button downwards towards the drum compartment cover. The but-
ton 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








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)
Finger pricker*
Slide button for undocking the
finger pricker
* 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 finger pricker at a glance
uPlunger
The plunger is a multifunction
button used to prime, trigger
and eject the lancet.
vWindow showing the penetra-
tion depth setting
wLancet holder
xLancet
yProtective cap on lancet
zPin-hole opening for lancet
ACap
BComfort Dial for depth selec-
tion (you change the depth by
rotating the cap)
CLocating notch
DLocating line
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16 Introduction
1.3 Main features
Docked finger pricker
The meter comes with an attached Accu-Chek Softclix Plus finger
pricker. 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.
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 (approxi-
mately 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 indica-
tor 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 com-
puter running the appropriate software or to special analysis systems.
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18 Introduction
Acoustic Mode
Acoustic Mode is intended for persons who are visually impaired. 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. For more information see Chapter 6.
Visually impaired persons need a sighted person to instruct them
in the use of the meter and to assist them with all aspects of its
operation. Visually impaired persons must not test their blood
glucose without assistance from a sighted person.
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19
Introduction
1
1.4 Display illustrations
Throughout this Reference 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 illustra-
tions 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 show blood glucose test results in
mg/dL and/or be set to 12-hour format.
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20 Initial steps before testing
2 Initial steps before testing
2.1 Checking the contents
Check that your monitoring kit is complete. The package contents are
listed on the box.
If anything is missing, please contact the Accu-Chek Customer Careline
free on 0800 701000 (UK) or 1800 709600 (Ireland).
2.2 Checking the blood glucose unit
Blood glucose results can be displayed in two different units of mea-
surement (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. The unit of measure normally used in the UK and
Ireland is mmol/L.
 Check that your meter displays the unit that is right for you.
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, please consult your dealer
or pharmacy. Using the wrong unit can cause you to misinterpret
the test results.
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