Accu-Chek Compact Plus User manual

0 4573196001(01) 01/05
008
8
BLOOD GLUCOSE MONITORING SYSTEM
User’s Manual
ACCU-CHEK and SOFTCLIX
are trademarks of Roche.
Made in Ireland for export to:
Roche Diagnostics
201 Boul.Armand-Frappier
Laval, Québec
CANADA, H7V 4A2
Accu-Chek Customer Care:
Montreal area: [phone]
Outside Montreal (toll free): 1-800-363-7949
www.accu-chek.ca
Roche Diagnostics GmbH
D-68298 Mannheim, Germany
www.accu-chek.com
AA
CCU-
CCU-
CHEK
HEK
®
Compact Plus

1
On the packaging, on the type plate of the meter and on the lancing
device you may encounter the following symbols shown here with
their meaning:
Please consult instructions for use
Catalogue number
For in vitro diagnostic use
Use by/ Expiry date
Lot number
Blood glucose meter and test strips:These products
fulfil the requirements of Directive 98/79/EC on in vitro
diagnostic medical devices.
Lancing device and lancets:These products fulfil the
requirements of Directive 93/42/EEC on medical devices.
Manufacturer
Caution (refer to accompanying documents). Please refer
to safety-related notes in the manual accompanying this
instrument.
For single use only
Sterilized using irradiation
Last update: January 2005
IVD
008
8
WARNING:Patients receiving peritoneal dialysis using solutions
containing Icodextrin (e.g.Extraneal, Icodial) should not use the
Accu-Chek Compact test strip.It could cause an overestimation
of glucose results.
TheAccu-Chek Compact Plus meter is intended for use by one
person only.
Use of the sameAccu-Chek Compact Plus meter for blood
glucose testing in more than one person poses an infection risk.
TheAccu-Chek Softclix Plus lancing device is intended for patient
self-monitoring by a single person.
It must not be used to collect blood from more than one person
as this poses an infection risk.
Any object coming into contact with human blood is a potential source
of infection (see:National Committee for Clinical Laboratory Standards:
Protection of LaboratoryWorkers from Instrument Biohazards and Infec-
tious DiseaseTransmitted by Blood,Body Fluids, andTissue.Approved
Guideline,NCCLS document M29-A, 1997).

2Contents 3
Contents
Contents
1 Introduction ................................................................................ 6
1.1 TheAccu-Chek Compact Plus blood glucose meter
at a glance .......................................................................... 6
1.2 TheAccu-Chek Softclix Plus lancing device at a glance ..... 10
1.3 Main features .................................................................... 12
1.4 About this User’s Manual ................................................... 15
2 Initial steps before testing ....................................................... 18
2.1 Checking the contents ...................................................... 18
2.2 Checking the blood glucose unit ........................................ 18
2.3 Inserting or replacing batteries .......................................... 19
2.4 Performing a full display check ......................................... 24
2.5 Inserting or replacing the test strip drum ........................... 26
3 Settings .................................................................................... 37
3.1 Turning the beep tone on/off ............................................. 41
3.2 Setting the year ................................................................ 43
3.3 Setting the time/date format ............................................. 44
3.4 Setting the time ................................................................ 45
3.5 Setting the date ................................................................ 47
3.6 Setting the alarm clock function ........................................ 49
3.7 Setting the hypo warning .................................................. 55
4 Testing blood glucose .............................................................. 58
4.1 Preparing the lancing device ............................................. 58
4.1.1 Undocking the lancing device from the meter ........ 60
4.1.2 Docking the lancing device onto the meter ............ 61
4.1.3 Inserting the lancet ............................................... 62
4.2 Testing blood glucose ........................................................ 65
4.2.1 Obtaining blood ..................................................... 67
4.2.2 Applying blood to the test strip .............................. 71
4.2.3 Ejecting the test strip ............................................ 74
4.2.4 Ejecting the used lancet ........................................ 77
4.2.5 Flagging special results ......................................... 80
4.3 Evaluating results ............................................................. 81
4.3.1 Plausible results .................................................... 81
4.3.2 Implausible results – possible
causes of error ...................................................... 82
5 Using the Accu-Chek Compact Plus meter as an
electronic notebook ................................................................. 84
5.1 Memory ............................................................................ 84
5.2 Viewing test results ........................................................... 85
5.3 Averages, highest value and lowest value
for 7,14 and 30 days ........................................................ 87
5.4 Downloading test results to a PC, handheld computer
or printer ........................................................................... 90

4Contents 5
Contents
6 Checking the Accu-Chek Compact Plus meter ....................... 94
7 Cleaning your Accu-Chek Compact Plus system ................. 104
7.1 Cleaning theAccu-Chek Compact Plus meter .................. 104
7.2 Cleaning theAccu-Chek Softclix Plus lancing device ....... 108
8 Measurement and storage conditions .................................. 109
8.1 Temperature range ......................................................... 109
8.2 Atmospheric humidity ..................................................... 111
8.3 Sources of interference ................................................... 112
9 Symbols, display messages and troubleshooting ................ 113
9.1 Symbols .......................................................................... 114
9.2 Display messages and troubleshooting ........................... 121
10 Technical data ........................................................................ 145
11 System components .............................................................. 148
12 Guarantee ............................................................................... 149
13 Patents .................................................................................... 150
14 Local customer support and service ..................................... 151
14.1 Information and repair ..................................................... 151
14.2 Contact us ...................................................................... 152
15 Alphabetical index ................................................................. 153

6Introduction 7
Introduction
1
6Drum release button
7Measuring window
8Test strip
9Test strip drum
10 Drum compartment cover*
11 M button
Press this button to retrieve results stored in the meter’s memory.
* available as replacement part
Front
1Display window
2S button
Press this button to change settings.
3Recess for docking the lancing device
4Test button
Use this button only if you want to test your blood glucose or per-
form a quality control check.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 turning
on inadvertently.
5Drum compartment
1 Introduction
1.1 The Accu-Chek Compact Plus
blood glucose meter at a glance
1
2
3
4
5
6
7
8
9
10
11
Front edge of the test strip
where blood is drawn up.

8Introduction 9
Introduction
1
Back
12 Battery compartment cover*
13 Infrared window
14 Batteries:
typeAAA, LR 03,AM 4,Micro
15 Battery compartment
16 Type plate
17 Lancing device*
18 Control window (shows the
number of strips remaining)
19 Slide button for undocking the lancing device
* available as replacement part
12
13
14
15
16
17
18
19

10 Introduction 11
Introduction
1
1.2 The Accu-Chek Softclix Plus lancing device at a glance
20 Plunger
The plunger is a multifunction button used to prime,trigger and
eject the lancet.
21 Window showing the penetration depth setting
22 Lancet holder
23 Lancet
24 Protective cap on lancet
25 Cap
26 Pin-hole opening for lancet
27 Comfort Dial (for depth selection)
28 Locating notch
29 Locating line
20
21
22
23
24
25
26
27
28
29

12 Introduction 13
Introduction
1
1.3 Main features
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 “Settings”).
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.
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.
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 measurement.If the measurement 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.
Warning of a possible hypo
You can turn on a visual as well as an acoustic signal to warn you if your
result is unusually low.This prompts you to check your result carefully
to see if you are heading towards a hypo.
Downloading data to a computer
The meter has an infrared window enabling you to download results to a
computer running the appropriate software.

14 Introduction 15
Introduction
1
Acoustic Mode
TheAcoustic Mode is intended for persons who are visually impaired.
When theAcoustic Mode is turned on, the meter guides the user
through the testing process using beep tones; it also outputs the result
as a series of beeps.
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.
A separate manual, the User’s Manual for Acoustic Mode,describes
Acoustic Mode and operation of the Accu-Chek Compact Plus meter in
Acoustic Mode.It contains information on beep tones,how and when
the meter uses them,and what they mean.Also contained in the sepa-
rate User’s Manual are descriptions of the operation of the meter and
lancing device that have been specially adapted to help sighted persons
instruct visually impaired persons in the functions of the meter or super-
vise its use.
For more information please contact theAccu-Chek customer care line.
Details are given at the end of this User’s Manual.
1.4 About this User’s Manual
Please read this User’s Manual carefully and completely before testing
your blood glucose for the first time.
This User’s Manual will help you get to know your newAccu-Chek
Compact Plus meter step by step.It will provide you with all the infor-
mation you need to operate and care for your meter and to deal with
any errors that might occur. Remember that,in order to keep your meter
in good working condition,you need to follow the correct operating
procedures and also observe certain other instructions.TheAccu-Chek
Compact Plus meter is a precision instrument.Improper treatment can
impair its function.
Should you have any questions, please contact theAccu-Chek customer
care line.Details are given at the end of this User’s Manual.
This User’s Manual features three symbols that 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 health.
This symbol draws attention to actions that could result in
damage to meter or lancing device.
iThis symbol draws your attention to other important information.

16 Introduction 17
Introduction
1
Throughout this User’s Manual you will see examples of what the dis-
play looks like.Any elements that flash are shown surrounded by a halo.
Example:
You have turned on the meter to perform a blood glucose test. In the
display you see the time,date,test strip symbol and blood drop symbol.
Both symbols are flashing.
The time,date and blood glucose results shown in the display are
intended only as examples.They will not be the same as those shown
by yourAccu-Chek Compact Plus meter.The blood glucose meter that
is depicted displays blood glucose results in mmol/L (see Chapter 2.2
“Checking the blood glucose unit”) and has been set to 24-hour format
(see Chapter 3.3 “Setting the time/date format”).
We recommend that you start by familiarizing yourself with all of the
elements of your meter shown on pages 6 - 11 of this User’s Manual.
Practise all of the operations described in this User’s Manual,and also
practise performing a test.

18 Initial steps before testing 19
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 theAccu-Chek customer care line.
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 (mmol/L
or mg/dL).Consequently,Roche sells two different versions of the same
meter.Check that your meter displays the unit you are accustomed to,
in Canada mmol/L.The type plate on the back of your meter indicates
which unit your meter uses.If you do not know which is the right unit
for you,ask your doctor.
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.
2.3 Inserting or replacing batteries
If the meter is on,press the Test button to turn it off.
Press lightly on the battery compartment cover and slide it in the
direction of the arrow.
Lift off the cover.

20 Initial steps before testing 21
Initial steps before testing
2
Remove any used batteries.
Insert two new batteries (type AAA,LR 03,AM 4 or micro).The
minus (-) ends of the batteries must match up with the minus marks
in the battery compartment.The plus (+) ends of the batteries must
match up with the plus marks in the battery compartment.
Re-attach the battery compartment cover.
The three hooks underneath the cover must engage with the slots
along the edge of the battery compartment.The cover is then just
loosely held in position.
Slide the battery compartment cover back in place.
There will be an audible CLICK as it closes.
iWhen you replace the batteries, your results always remain
saved.
The year,time and date settings,however,only remain saved as long as
you don’t take longer than two minutes to change the batteries,
you don’t press any button while no batteries are inserted,
you don’t open the drum compartment while no batteries are in-
serted.
If one of the above conditions is not met,you will need to re-enter the
year,time and date (see Chapter 3 “Settings”).
If you do not enter the year,time and date,all future results will be dis-
played and saved without the time and date. In that case the test results
saved in memory will be numbered consecutively so you can still recog-
nize the order in which they were saved.
iA new pair of batteries has enough power for at least 1000 tests
or to last one year.If you use the meter in Acoustic Mode,they
will not last as long.

22 Initial steps before testing 23
Initial steps before testing
2
iWhen the battery symbol first appears in the display the bat-
teries are running low.You can perform about 50 more tests.You
should,however,replace the batteries as soon as possible.By
then the batteries will have been heavily drained,and variable
conditions (e.g.cold surroundings) can affect their performance
even further.
iYou can also use rechargeable NiMH batteries. However,if you
do,the number of tests you can perform with recharged batteries
is considerably less than with ordinary batteries.Please also note
the following:
To be ready to test at any time,you will need two recharge-
able batteries in reserve which you can charge while the first
pair are in the meter.
Recharged batteries lose their charge during storage.
When the battery symbol first appears, you can perform
significantly fewer than 50 more tests.With old and ex-
hausted rechargeable batteries you may not even be able to
perform one more test.
The performance and useful life of rechargeable batteries
depends to a large extent on the quality of the battery charg-
er you are using.
Owing to the higher power consumption in Acoustic Mode,
we advise against using rechargeable batteries if you want to
use yourAccu-Chek Compact Plus meter in Acoustic Mode.
iIt is a good idea to use up the test strip drum that is in the meter
before you replace the batteries. If the drum remains in the meter
while you change the batteries, it may take the meter a long time
to advance the next strip from the drum.The meter can also no
longer calculate the 90-day use-by deadline (see Chapter 2.5
“Inserting or replacing the test strip drum”).
Never throw batteries into a fire.This is dangerous because they
may explode.
iRemove the batteries if you will not be using your meter for any
length of time.
iThink of the environment.Dispose of used batteries sensibly.

24 Initial steps before testing 25
Initial steps before testing
2
2.4 Performing a full display check
To check that all of the elements are properly displayed, you should
carry out a full display test.
Press and hold down the M button.
The meter turns on.As long as you hold down the M button, all the
display elements are visible.Compare the display screen of your meter
with the one shown below.
mmol/L meter mg/dL meter
or
All elements displayed
In Canada your meter should display mmol/L.If any of the display ele-
ments are missing or the unit shown for the blood glucose result is not
the correct one,please ask your healthcare professional or pharmacist.
You can also contact theAccu-Chek customer care line. Details are
given at the end of this User’s Manual.
Release the M button.
The standard display test screen that is shown each time the meter
is turned on appears briefly.When it disappears, the meter is in
memory mode.As no results have yet been saved, three bars are
displayed.
Press theTest button to turn the meter off.
iThe meter automatically turns off if you keep the M button
pressed for more than 60 seconds.
iYou can perform a full display test whenever you wish.If there
are already results saved in memory,the most recently saved
result is displayed when you release the button.

26 Initial steps before testing 27
Initial steps before testing
2
2.5 Inserting or replacing the 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 before you open the meter.
Only open the meter when it is turned off and the motor is not
running.Opening the drum compartment when the meter is
turned on may result in damage to the meter.
Open the drum compartment cover by lifting where it projects
slightly to the right of the test strip guide.
Irrespective of whether a test strip drum is inserted or not:
Press the red drum release button.
The pin holding the test strip drum in position retracts with an
audible CLICK.

28 Initial steps before testing 29
Initial steps before testing
2
If there is a test strip drum in the meter:
Tip the meter forwards.
The test strip drum drops out.
iYou can dispose of used test strip drums with your regular
household waste.
Insert a new test strip drum.Always make sure that the bar codes
are inserted on top.
Close the drum compartment cover and push it shut.
There will be an audible CLICK.
iEnsure that the drum compartment cover is tightly closed.If it is
not properly closed,you cannot turn the meter on by pressing the
Test button.
The meter turns on and rotates the 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.

30 Initial steps before testing 31
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
perform a blood glucose test,the meter counts the number of test strips
that you have used and displays the number of strips remaining.
Use only test strips that are within the expiration date.Expired
test strips can produce incorrect results.Incorrect results can
cause the wrong therapeutic decision to be taken and so produce
adverse health effects.The expiration date is printed next to the
symbol on the container the drum came in.
Product Limitations
Please read the literature packaged with your test strip drum to
find the latest information on product specifications and limita-
tions.
Use only new test strips.Make sure the aluminium foil (the “silver
ends”) is intact on both sides.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 can produce ad-
verse health effects.
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 the container the drum came in.The left
portion may be peeled off.On it are two different concentration
tables forAccu-Chek Compact Control and Accu-Chek Compact
Autocontrol solutions.The stated concentrations are valid only
for the test strips contained in this particular drum.You need the
tables to check your meter.You may,for instance, wish to stick
the peel-off label in your notebook or diary.When conducting a
quality control test always check that the peel-off label with the
concentration table belongs to the test strips that are currently in
the meter (see Chapter 6 “Checking theAccu-Chek Compact Plus
meter”).

32 Initial steps before testing 33
Initial steps before testing
2
iUse onlyAccu-Chek Compact test strip drums. Other test strips
cannot be used to perform tests.
If you insert a different test strip drum,the following message will be
displayed:
When all the strips have been used, the dot reappears in the control
window.
Insert a new test strip drum.
If you do not insert a new test strip drum,the following message will be
displayed the next time you turn the meter on:
End and the drum symbol are displayed flashing to indicate that the test
strip drum is empty.
iOnly open the drum compartment when you intend to insert
a new test strip drum or the meter requests you to clean the
measuring window (see Chapter 7.1 “Cleaning theAccu-Chek
Compact Plus meter”).If you open the drum compartment
prematurely,the meter assumes that you have inserted a drum
that is already partly used (see below).
When you insert a new drum,the meter starts to count the number
of days the drum has been in the meter.Each drum must be used up
within a 90-day use-by period.
If a drum has been in the meter for more than 90 days and you turn the
meter on to perform a blood glucose test,the following symbols appear
flashing in the display:
test strip and blood drop,indicating that you may now apply blood,
drum,bottle and clock,indicating that the 90-day use-by period for
the drum has expired.

34 Initial steps before testing 35
Initial steps before testing
2
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
produce adverse health effects.
Insert a new test strip drum.
The meter is unable to calculate the 90-day use-by period if you
remove a partly used drum from the meter and then insert it again,
take longer than two minutes to replace the batteries (in which case
the year,date and time settings are lost) and a partly used drum
remains in the meter.
The meter has no way of telling 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 blood glucose test,the following symbols appear flash-
ing in the display:
test strip and blood drop,indicating that you may now apply blood,
drum and bottle,indicating that the use-by period cannot be calcu-
lated.
You are requested to perform a quality control test in order to check the
test strips.Perform a quality control check (see Chapter 6 “Checking the
Accu-Chek Compact Plus meter”).If the test produces a correct result,
you may continue to use the test strips.If the result is incorrect, you
need to insert a new drum.

36 Initial steps before testing 37
Settings
3
Following the quality control check,the bottle symbol disappears from
the display.The drum symbol continues to flash in order to draw your
attention to the fact that the meter cannot calculate the 90-day use-by
period or the drum symbol and the clock both flash to indicate that the
drum has been in use for more than 90 days.If you do not perform a
quality control check,the flashing bottle symbol appears with every test
until you insert a new drum.The drum symbol or the drum and clock
symbols only disappear when you insert a new drum.All results are
saved with the flashing drum symbol or, where appropriate,with both
the flashing drum and clock symbols.
iIf you insert a partly used drum in the meter,a dot appears in the
control window at the back.When you next turn the meter on,it
rotates the drum until it finds the first chamber containing a test
strip.The fewer test strips there are in the drum, the longer the
process takes.The control window allows you to see the drum
being rotated from one chamber to the next.
3 Settings
You can change the settings of your meter to turn the beep tone on or
off,to select the year, the time/date format,the time and the date,and
to activate the alarm clock function and the hypo warning.
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.
When you turn the meter on for the first time,it has the following pre-
settings (which you can change).
The beep tone is on,Acoustic Mode is off: On 1
Year:current year, e.g.2005
Time/date format:
24 h display format with accompanying day-month/DD-MM
date format
Time:current time based on Eastern StandardTime (EST)
Date: current date based on Eastern StandardTime (EST)
Alarm clock function:OFF
Hypo warning:OFF