Accu-Chek Compact Plus User manual

BLOOD GLUCOSE MONITORING SYSTEM
Reference Manual
ACCU-CHEK
®
Compact Plus

3
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:
The explanation of any other symbols can be found in the instructions/
inserts, accompanying components within the packaging.
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
Last update: 2008-07

4Intended use 5
Intended use
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.
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).

6About this Reference Manual 7
About this Reference Manual
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.
"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 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.
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.

8Contents 9
Contents
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
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

10 Contents 11
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
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

12 Introduction 13
Introduction
1
:
8
9
7
/
0
1
2
3
4
6
5
1 Introduction
/Display window
0S button
Press this button to change settings.
1Recess for docking the finger pricker
2Test 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.
3Drum compartment
4Drum release button
5Test strip guide
6Measuring window
7Test strip
8Test strip drum
9Drum compartment cover*
:M Button
Press this button to retrieve results stored in the meter’s memory.
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
* available as replacement part

14 Introduction 15
Introduction
1
u
v
w
x
y
C
B
A
z
D
B
A
@
;
<
=
>
?
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)
AFinger pricker*
BSlide button for undocking the
finger pricker
* available as replacement part
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

16 Introduction 17
Introduction
1
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.
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.

18 Introduction 19
Introduction
1
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.
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.

20 Initial steps before testing 21
Initial steps before testing
2
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.
2.2.1 Type plate
The type plate on the back of your meter indicates which unit of mea-
surement your meter uses.
2.2.2 Display check
You can check the unit of measurement your meter uses by performing
a display check.
 Press and hold down the M button.
The meter turns on. While you hold down the M button, you first see the
display check.
mmol/L meter or mg/dL meter
The unit of measurement is shown in the bottom right corner of the dis-
play.

22 Initial steps before testing 23
Initial steps before testing
2
If you continue to hold down the M button, you then see the following
display after approximately 2 seconds.
mmol/L meter mg/dL meter
or
When you release the M button, your meter is in memory mode. As long
as no results have yet been saved, three bars are displayed.
 Press the Test button to turn the meter off.
Notes
iIf additional lines appear during the display test or parts of the
numeric field or of a symbol are missing, please contact the
Accu-Chek Customer Careline free on 0800 701000 (UK) or
1800 709600 (Ireland). If the numeric field
 (mmol/L meter)
or
 (mg/dL meter) is affected, the meter may not show your
test results correctly.
iThe meter automatically turns off after 60 seconds even if you
keep the M button pressed.
iYou can perform a display check whenever you wish. If there are
results already saved in memory, the most recently saved result
is displayed when you release the M button.

24 Initial steps before testing 25
Initial steps before testing
2
 Hold the meter in your right hand and place the thumb of your left
hand into this recess. Then pull the drum compartment cover with
your fingers slightly to the front and lift it up.
Irrespective of whether a test strip drum is inserted or not:
 Press the red drum release button.
2.3 Inserting or replacing the test strip drum
If your meter is brand new and unused, it will contain a mock drum (an
empty drum without a label), which you must remove and replace with a
test strip drum.
 Read the package insert that came with the test strip drums.
 If the meter is on, press the Test button to turn it off.
 Wait for the motor to stop.
Set into the bottom of the meter to the left of the finger pricker is a
recess. The upper part of this recess belongs to the drum compartment
cover.
Drum compartment cover
Recess

26 Initial steps before testing 27
Initial steps before testing
2
The pin holding the test strip drum in position retracts with an audible
CLICK.
If there is a test strip drum in the meter:
 Tip the meter forwards.
The test strip drum drops out.
 Insert a new test strip drum in the meter as illustrated (the two rows
of bar code must be nearest the display window).
 Close the drum compartment cover and push it shut. There will be
an audible CLICK.
The meter turns on and rotates the test strip drum until the first test
strip is in the correct position. At the same time the meter reads the bar
code that provides it with information on the specific characteristics of
the test strips. After that, the meter turns off.

28 Initial steps before testing 29
Initial steps before testing
2
A dot appears in the small control window on the back of the meter. This
indicates that you have just inserted a test strip drum. When you per-
form a blood glucose test, the meter counts the number of test strips
that you have used. The number of strips remaining is displayed in the
control window.
When all the test strips in a drum have been used up, the dot reappears
in the small control window.
 Insert a new test strip drum.
If you do not insert a new drum, the following message appears the next
time you turn on the meter:
H> and the drum symbol are flashing to indicate that the test strip
drum is empty.
Notes
Use only test strips that are not beyond their expiry date.Test
strips that have expired can produce incorrect results. Incorrect
results can cause the wrong therapeutic decision to be taken and
so produce serious adverse health effects. The expiry date is
printed on the pack and on the peel-off label on the drum con-
tainer next to the symbol.

30 Initial steps before testing 31
Initial steps before testing
2
New test strip drums where the aluminium foil (the silver ends) is
damaged cannot be used. Your blood glucose results may be
incorrect if you use a damaged drum. Incorrect results can cause
the wrong therapeutic decision to be taken and so produce
adverse health effects.
Only open the drum compartment cover when the meter is turned
off and the motor is not running. Opening the drum compartment
cover when the meter is turned on may result in damage to the
meter.
iHandle the test strip drums with care! Only remove a test strip
drum from its container when you intend to use it. The container
protects the aluminium foil on the drum from damage.
iThere is a label on every drum container. The left portion may be
peeled off. On it is the concentration table for the Accu-Chek
Compact Autocontrol control solutions. The stated concentrations
are valid only for the test strips contained in this drum. You need
this table for the performance check of your meter (see Chapter
7). You may, for instance, wish to stick the peel-off label in your
notebook or diary. When conducting a performance check,
always check that the peel-off label with the concentration table
belongs to the test strip drum that is currently in the meter.
iIf you insert a partly used drum in the meter, the meter rotates
the drum so the dot appears in the control window on the back.
When you subsequently turn on the meter to perform a test
and ...
"... you have re-inserted a same drum you previously
removed:
The meter immediately rotates the drum to the first chamber
that contains a test strip, and ejects the strip.
"... you have used up the previous drum or have replaced one
partly used drum with another partly used one:
The meter may search all chambers until it finds the first one
that contains a test strip. The fewer test strips the drum con-
tains, the longer the process takes.
If the meter immediately rotates the drum to one of the
chambers near the end (you can tell by the noise of the motor
that rotates the drum), the drum may ultimately still contain
test strips even though the meter regards it as empty. You can
still use the test strips by inserting the drum again.

32 Initial steps before testing 33
Initial steps before testing
2
iIf you insert a partly used test strip drum into the meter, the
meter cannot calculate the use-by period for that drum. Conse-
quently, the next time you perform a test, the drum symbol and
flashing bottle symbol are displayed to highlight the fact (see
Chapter 2.3.1).
iUse only Accu-Chek Compact test strip drums. Other test strips
cannot be used to perform tests. If you insert a different test strip
drum, error message E22 is displayed (see Chapter 12.2).
iMake sure that the drum compartment cover is tightly closed. If it
is not properly closed, the meter will not turn on when you press
the Test button. All you see is the display check briefly.
iYou can dispose of used test strip drums with your regular
household waste.
2.3.1 Test strip drum use-by period
When you insert a new drum into the meter, the meter starts to count
the number of days the drum is in the meter. Each drum must be used
within a 90-day use-by period.
Once a drum has been in the meter for 90 days, its use-by period has
expired. The next time you turn the meter on to perform a test, the drum
symbol, bottle symbol and clock symbol are displayed to highlight the
fact.
 Insert a new test strip drum.
Note
The test strips in this drum cannot be used. You must not use
these test strips as they may produce incorrect results. Incorrect
results can cause the wrong therapeutic decision to be taken and
so produce serious adverse health effects.

34 Initial steps before testing 35
Initial steps before testing
2
The meter is unable to calculate the 90-day use-by period if
"you insert a partly used drum in the meter, even if it is the same one
you have just removed,
"the year, date and time settings are lost when you replace the bat-
teries (see Chapter 9), and a partly used drum remains in the meter.
The meter has no way of telling you in these cases when the drum was
first inserted or how long the partly used drum has already been in the
meter.
If the meter cannot calculate the use-by period and you turn the meter
on to perform a test, the following symbols appear in the display:
"Flashing test strip and flashing drop, indicating that you may now
apply blood or control solution
"Drum, indicating that the use-by period cannot be calculated
"Flashing bottle, prompting you to perform a performance check in
order to check the test strips
 Perform a performance check (see Chapter 7).
If the result from the performance check is within the stated concentra-
tion range, you can still use the test strips remaining in the drum. If the
result is outside the range, you need to insert a new drum.
Following the performance check, the bottle symbol disappears from the
display. If you do not perform a performance check, the flashing bottle
symbol appears with every test until you insert a new drum. The drum
symbol continues to be displayed with each test in order to draw your
attention to the fact that the meter cannot calculate the use-by period.
All results are saved along with the drum symbol. The drum symbol only
disappears when you insert a new drum.

36 Initial steps before testing 37
Initial steps before testing
2
2.3.2 Indication of the number of test strips remaining
Each time you turn the meter off with the Test button, it shows you the
number of test strips remaining in the drum. The number of remaining
strips continues to be displayed as long as you hold down the Test
button.
In this example there are still 12 test strips in the drum.
When you release the Test button, the meter turns off.
Notes
iIf the test strip drum contains three or fewer test strips following
a test, the number, the test strip symbol and drum symbol flash in
the display window.
iIf you press the Test button only briefly when turning the meter
off, the number of test strips remaining is displayed only briefly
or not at all.
iIf you have not performed a test since last replacing the drum,
the meter cannot tell how many test strips there are left in the
drum. This is e.g. the case when, after you have changed the
drum, you start by changing settings or retrieve results from
memory. If you then press the Test button to turn the meter off,
only three horizontal bars are displayed instead of the
number of test strips remaining. Only when you have performed
a test with the newly inserted drum does the meter display the
number of test strips remaining each time you turn the meter off
with the Test button.

38 Settings 39
Settings
3
3 Settings
When you turn the meter on for the first time, it has the following pre-
settings. These are factory defaults that you can change.
"Beep tone on, Acoustic Mode off
"Brightness of the display: medium
"Year: current year, e.g. 2007
"Time-and-date format: 24-hour format;
24-hour format is associated with the date format day-month
(DD-MM)
"Time: current time based on Central European Time
"Date: current date based on Central European Time
"Alarm clock function off
"Hypo indicator off
Notes
iIf the year, time and date settings were lost as a result of a bat-
tery replacement (see Chapter 9) and you fail to reset these, the
meter displays the time as 0:00 and the date as 0-00 (in 24-hour
format as well as in 12-hour format) when you perform a test.
In memory the results are saved not with the time and date but
with their memory location number (see Chapter 5.2). Without the
time and date the meter is not able to calculate averages, nor the
lowest and the highest values (see Chapter 5.3). Results sent to a
You can change the settings of your meter to turn the beep tone or
Acoustic Mode on or off, to set the brightness of the display, to select
the time-and-date format, to set the year, the time and the date, and to
activate the alarm clock function and the hypo indicator.
Beep tone: When the beep tone is set to on, it provides user support
during testing by marking the start of each step acoustically.
Acoustic Mode: When Acoustic Mode is turned on, the meter guides
you through the blood glucose test using beep tones; it also outputs the
result as a series of beeps.
Alarm clock function: You can set the meter to remind you to test your
blood glucose.
Hypo indicator: You can set a personal hypo indicator level. If your
result is below this level, the meter alerts you to the fact that you are
possibly heading towards a hypo.
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.
You can perform blood glucose tests without adjusting any of the set-
tings. All settings are the default factory settings (see next page).