ACCU-CHEK and SOFTCLIX are trademarks of a Member of the Roche Group.

©2002 Roche Diagnostics. All rights reserved.

Distributed by:

Roche Diagnostics Ltd

Bell Lane, Lewes

East Sussex BN7 1LG www.accu-chek.co.uk

Freephone 0800 701000 (UK)

1 800 709600 (Ireland)

Roche Diagnostics GmbH

D 68305 Mannheim, Germany www.accu-chek.com

BLOOD GLUCOSE SYSTEM

REFERENCE

MANUAL

CONTENTS

1

Introduction

2

Inserting or replacing batteries

3

Inserting or replacing the test strip drum

6

10

16

4

Settings

4.1

Enabling/disabling the beep signal

4.2

Setting the year

4.3

Changing the date/time format

4.4

Setting the time

4.5

Setting the date

5

Testing blood glucose 38

5.1

Selecting the depth of penetration of your

Softclix lancing device

5.2

How to take a blood sample

38

40

5.3

Softclix Lancet 43

5.4

Testing blood glucose

5.5

Testing conditions

44

52

6

Reviewing stored blood glucose results

26

28

30

32

34

36

54

CONTENTS

6.1

Highest value, lowest value, average

6.2

Downloading test results to a computer

7

Checking, cleaning and storing your meter

7.1

Checking the meter

7.2

Cleaning the meter

7.3

Storing the meter

8

Technical data

9

Warranty

70

72

10

Troubleshooting Guide

11

Display messages

14

About the Accu-Chek Softclix

15

Alphabetical Index

74

76

12

Customer support and service 96

13

Components of the Accu-Chek Compact System 98

103

104

56

58

60

60

64

69

3

4

5

6

1

2

Display window

ON/OFF button

MEMO button

SET button

Optical system

Drum compartment release button

7 Drum compartment

8

9

Test strip drum

Test strip

10

11

Optical system cover*

Display cover*

10

5

11

3

1

2

9

Front edge of strip that draws up the blood

6

7

8

* available as replacement part if necessary

4

2

3

4

12

Infrared window for data transmission - Accu-Chek

Compass Software qavailable separately

13

Window (indicates the remaining number of test strips)

14 Battery compartment

15

Batteries: 2 x Type AAA

16 Cover for the battery compartment*

17

Test strip guide

13

17

15

16

12

14

* available as replacement part if necessary

5

6

1

Introduction

Accu-Chek Compact is a completely new type of blood glucose meter for people with diabetes who test their own blood glucose regularly. We have designed it to be as easy and safe to use as possible. You will quickly discover that

Accu-Chek Compact is a reliable blood glucose meter that you can take anywhere.

Operating

Accu-Chek

Compact is easy: there is just one button to press to perform a test. You no longer have to handle individual test strips, as they now come conveniently loaded in a drum. Each drum holds 17 strips and two simple steps are all it takes to insert the drum into the meter.

Coding occurs automatically. When you want to take a blood glucose reading, just press the button and a test strip moves from the drum into the correct position. Once you have completed the test, just press the button again and the strip is ejected automatically. Your results are stored in memory and can be transferred to your computer if you wish. Accu-Chek Compass

Software is available separately. Accu-Chek

Compact stores up to 100 test results together with date and time.

We recommend that you use an Accu-Chek

Softclix lancing device to obtain capillary blood samples. Blood collection with an Accu-Chek

Softclix lancing device is virtually painless.

With Accu-Chek Compact you have all you need to monitor your blood glucose quickly and simply, anywhere, at any time.

7

8

1

Introduction

This User’s Manual gives you full details on how to operate

Accu-Chek Compact. It also tells you how to clean and look after your meter. At the back of the Manual is a list of all possible error messages with recommendations for troubleshooting.

Please read carefully all text preceded by the following symbols:

Warning!

This warns of a situation that may pose a risk to your health (e.g. as a result of you calculating the wrong insulin dose).

Caution!

This symbol indicates that your meter is at risk of being damaged (e.g. through improper cleaning), or that there may be a problem during testing.

Important!

This label highlights important information that will help you get the most out of your meter.

Please take time to read this Manual and the instructions that came with your test strip drums.

Also, when you have a quiet moment, practice testing. To help you learn, check the instructions and other information in this Manual against the description of the meter’s parts on pages 2-5.

9

10

10

2

Inserting or replacing batteries

1

2

If the meter is on, turn it off.

Press lightly on the lid of the battery compartment and slide it in the direction of

2

.

Opening the battery compartment

11

12

2

Inserting or replacing batteries

Remove any used batteries.

Insert two batteries (type AAA).

Make sure that the minus (-) pole of the battery is next to the minus contact in the battery compartment.

A new set of batteries provides enough power to carry out a minimum of 500 blood glucose tests. When battery power is low, the battery symbol will appear. You can then perform a maximum of 50 more blood glucose tests.

Battery types

13

14

2

Inserting or replacing batteries

Replacing the batteries

When you replace the batteries, your stored results are retained in memory. However, you will need to re-enter the date and time. If you fail to do so, any blood glucose test results you obtain from this point forward will be displayed and saved without the date and time. In this case, the test results saved in memory will be numbered consecutively so you can still see the order in which you took the readings.

To keep things simple, we recommend you use up any current drum of strips before replacing the batteries. Otherwise, it may take the meter a long time to advance the first test strip from the next drum, and the

“use-by” date warning may also be lost.

(See Chapter 3).

Important!

15

3

Inserting or replacing the test strip drum

16

If the meter is on, turn it off. Wait for the motor to stop before you open the meter.

Slide the release button on the right side of the meter in the direction indicated by the arrow. The drum compartment opens.

Opening the drum compartment

17

3

Inserting or replacing the test strip drum

18

To exchange the drum, first tip the meter upright. The old drum drops out.

19

3

Inserting or replacing the test strip drum

20

Insert the new drum.

Close the drum compartment.

The meter automatically moves the drum to the correct position and reads the code on the drum.

Closing the drum compartment

21

22

3

Inserting or replacing the test strip drum

13

reverse side of the meter. This dot indicates that you have inserted a new, full drum containing 17 test strips. When you perform a blood glucose test, the meter counts the number of test strips that have been used and displays the number of strips remaining.

When all the strips have been used, the dot reappears in the control window. “End” flashes in the display, indicating that the drum is empty

23

24

3

Inserting or replacing the test strip drum

Handle the test strip drums with extreme care!

If the aluminium foil (the silver ends) on a new test strip drum has been damaged, do not use it. If you do, your blood glucose test results may be incorrect.

Once you remove a drum from the drum vial, you have 90 days to use up all the test strips.

The meter counts the number of days remaining.

Do not open the drum compartment until all of the strips have been used. Whenever the drum compartment is opened and closed, or when the batteries are replaced, the meter thinks a new drum has been inserted, and resets the 90-day countdown.

Warning!

If an open test strip drum is removed from the meter and reinstalled, the 90-day “useby” period displayed on the meter ceases to have any significance. The message “CTRL” flashes in the display indicating that a quality control test should be performed. Perform a quality control test (as described in Chapter

7.1) to ensure that the strips are still usable.

The display indicating the 90-day “use-by” period (flashing drum symbol and date) is still invalid, however.

If you use expired test strips, you may obtain incorrect blood glucose test results.

25

4

Settings

26

You may now move to the SET menu to enable or disable the beep signal, to set the year, date and time, and to define the time and date format.

SET menu

Press the SET button to call up the SET menu.

The field currently flashing may now be changed.

To quit the SET menu, press the ON/OFF button.

27

28

4.1

Enabling/disabling the beep signal

When the beep signal is enabled, the meter beeps when it starts to test, as confirmation that the test strip has received a sufficient amount of blood or control solution. It also beeps each time it displays a message.

SET button

1. Check that the meter is off and press the SET button. The meter turns on without advancing a test strip from the drum.

2. The symbol for the beep signal flashes in the display window, and “ON” appears.

MEMO button

3. Press the MEMO button to disable the beep signal. “OFF” appears in the display.

If you press the MEMO button again,

“ON” reappears.

ON/OFF button

4. If you wish to set the year, leave the meter turned on and proceed to step 2 in the next section.

29

4.2

Setting the year

SET button

1. Check that the meter is off and press the

SET button. The meter turns on without advancing a test strip from the drum.

2. Press the SET button repeatedly until the current year setting flashes at top right of the display.

30

MEMO button

3. Press the MEMO button to adjust the year.

The meter scrolls upwards through the year values. If you hold the MEMO button down, the meter fast-scrolls forward to 2032 and then begins again at 2000.

ON/OFF button

4. If you wish to define the date and time format, leave the meter turned on and proceed to step 2 in the next section.

The year is not displayed during testing or review of blood glucose test results. It is still important, however, as February 29 in a leap year will only be recognized when the year is properly set. The current year setting is also needed to correctly identify your blood glucose test results if you transfer them from your meter’s memory to a computer.

Important!

31

4.3

Changing the date/time format

If you have a new meter or you have just replaced the batteries, the date will be set to 01.01.2000, and the time to

00:00 hours. The correct date and time are needed to enable you to correctly identify your blood glucose test results and to transfer them from your meter’s memory to a computer (see Chapter 6.2).

You can choose between the standard 24-hour format

(0:00 to 24:00), in which case the date format is DD.MM.YY

(day, followed by month, followed by year), and the 12-hour format (0 to 12 o’clock with a.m. or p.m.). In the latter case, the date format changes to MM.DD.YY, i.e. month, followed by day, followed by year.

32

SET button

1. Check that the meter is off and press the SET button. The meter turns on without advancing a test strip from the drum.

2. Press the SET button repeatedly until “24h” is displayed. 24-hour format is selected.

MEMO button

3. Press the MEMO button to select 12-hour format. In the display you see “12h” and the

12-hour display is set to a.m.

ON/OFF button

4. If you wish to set the date, leave the meter turned on and proceed to step 2 in the next section.

If you do not set the date and time, these fields will be filled with zeros during testing.

Your blood glucose test results saved in memory will be numbered consecutively.

However, only blood glucose results that are saved with the date and time will be included in the statistical display (please see Chapter 6.1).

Important!

33

4.4

Setting the time

SET button

1. Check that the meter is off and press the SET button.

The meter turns on without advancing a test strip from the drum.

2. Press the SET button repeatedly until the hour field flashes.

MEMO button

3. Press the

MEMO button repeatedly to set the hour.

34

SET button

4. Press the SET button again. The minute field flashes.

MEMO button

5. Press the MEMO button repeatedly to set the minute.

ON/OFF button

6. If you wish to set the date, leave the meter turned on and proceed to step 2 in the next section.

Caution!

At temperatures below minus 10°C, the batteries do not have enough power to keep the internal clock functioning. In this event the clock must be reset.

Instead of pressing the MEMO button repeatedly, you can hold it down to scroll forward quickly.

Important!

35

36

4.5

Setting the date

SET button

1. Check that the meter is off and press the

SET button. The meter turns on without advancing a test strip from the drum.

2. Press the SET button repeatedly until the month field flashes.

MEMO button

3. Press the MEMO button repeatedly to select the correct month.

SET button

4. Press the SET button. The day field flashes.

MEMO button

5. Press the MEMO button repeatedly to select the correct day.

ON/OFF button

6. Press the ON/OFF button to turn the meter off. The current settings will be saved automatically.

37

38

5

Testing blood glucose

5.1

Selecting the depth of penetration of your Accu-Chek

Softclix lancing device

Depth of penetration should be selected so that only the amount of blood necessary for testing is obtained.

For this purpose

Accu-Chek Softclix can be set to different penetration depths ranging from 0.5 to 5.5. They are indicated on the cap by the numbers 1 to 5.

The additional intermediate settings marked with dots enable a particularly precise adjustment of

Softclix to suit individual skin type.

The markings on the device shows the depth of penetration selected. Penetration depth can be altered by turning the front part of the cap. You will hear the cap click into position, indicating adjustment to a new depth and simultaneously preventing any accidental alteration of penetration depth.

Number 0.5 corresponds to the smallest depth of penetration and number 5.5 the greatest.

When selecting the individual penetration depth it is recommended to start with level 1 or

2 to see if the amount of blood obtained is enough to carry out the test. Thicker skin will require a higher level.

Recommended Penetration Settings

• 0.5-1.5 for soft skin

• 2-3.5 for normal skin

• 4-5.5 for thicker skin

39

40

5.2

How to take a blood sample

1

3

5

7

2

4

6

1. Pull off the cap from the Accu-Chek

Softclix instrument.

2. Insert a new Softclix lancet as far as it will go into the lancet holder and push it in until it clicks.

3. To remove the protective cap, twist and then pull it.

4. Press the Accu-Chek Softclix cap on again until it clicks. Be sure to align the notch on the cap with centre of the semi-circular cut-out on the ejector.

5. First check that you have set the desired penetration depth. Press in the priming button until it clicks. Be careful not to press the release button at the same time. The lancing device is primed when a yellow dot appears in the transparent release button.

6. Wash and dry hands thoroughly. Milk the blood from the wrist down to the end of the fingers. Hold the Accu-Chek Softclix against the finger tip - or you can use your ear lobe and press gently. You will feel the thin ring around the opening of the cap and sense the exact point of penetration. Press the release button.

41

42

Wait a few seconds to allow the puncture site to open so that a drop of blood can form.

Apply the blood drop to the strip. Then carry out the test according to the instructions that come with the strips or meter.

7. To remove the lancet, pull off the Accu-Chek

Softclix cap. To eject the used lancet slide the ejector forwards to remove it, and dispose of the lancet in a sealed container.

To avoid infections use a new lancet each time you take a blood sample.

Using each lancet only once helps ensure virtually pain free blood sampling.

Selecting the Puncture Site

The best place to take capillary blood is from the side of a fingertip as it has the best blood supply and registers the least pain.

Preparing Fingertip or Earlobe

Wash your hands in warm water and dry them well. This helps ensure proper hygiene and stimulates blood flow, since the drop may be too small if the finger to be pricked is too cold or circulation is poor. In addition finger or earlobe should be massaged before pricking.

5.3

Softclix Lancet

Use the Softclix lancet to operate Accu-Chek

Softclix. These lancets are manufactured to such a high standard of accuracy that the individual penetration depth selected on

Accu-Chek Softclix remains unchanged when a new lancet is inserted and consequently there is no need to reset Accu-Chek Softclix.

Available in packs of 200 lancets.

Note on Patent Situation

This Accu-Chek Softclix device and its use are protected by US Patent US Re 35803 and other intellectual properties EP-B-0782838,

EP-A-1034740, Des. 429814.

Upon purchase you have acquired the right to use your Accu-Chek Softclix exclusively with

Accu-Chek Softclix ® lancets.

Safety Remarks

Only use a Softclix lancet with the Accu-Chek

Softclix device since the use of other lancets may prevent or impair proper function of

Accu-Chek Softclix.

43

44

5.4

Testing blood glucose

Blood glucose results are displayed in mmol/L. If your meter displays mg/dL contact our Accu-Chek Customer Careline

(Refer to Chapter 12: “Customer Support and Services”).

Using the wrong meter/unit can cause you to wrongly interpret the test results.

Warning!

Wash your hands thoroughly with warm water and dry them well.

Open the display cover.

Press the ON/OFF button. The meter turns on.

“ON” appears in the display window, followed by and the date line. Shortly afterwards a test strip is advanced from the drum.

45

46

5.4

Testing blood glucose

With a lancing device such as Accu-Chek

Softclix, prick the side of a fingertip. Gently squeeze the fingertip to develop a small drop of blood.

Wait until the flashing hand symbol and blood drop symbol appear in the display and the meter beeps (if beep signal is enabled).

Hold the meter so the test strip is pointing downwards at a slight angle (see illustration).

Gently touch the front edge of the test strip against the blood. The strip draws up the blood. As soon as the correct amount of blood has been drawn in, the meter beeps and the test commences automatically. The meter recognizes if too little blood has been applied and displays an error message. appears in the display at the start of the test.

Applying blood

47

48

5.4

Testing blood glucose

The in the display gradually disappears.

When it has totally disappeared, the test is complete and the test result is displayed.

The test strip symbol flashes. Press the

ON/OFF button. This saves the test result in memory, releases the strip and turns the meter off. Hold the meter upright so the used test strip falls out at the bottom.

Used test strip ejected

49

50

5.4

Testing blood glucose

If your blood glucose test result does not agree with the way you feel, please contact your doctor and perform a quality control check with Compact

Control Solutions and a new test strip. If the message HI is displayed, your blood glucose result is above 33.3 mmol/L. If the message

LO is displayed, your blood glucose result is below 0.6 mmol/L. The results obtained will not be used in statistical calculations (see Chapter 6.1

“Highest value, lowest value, average”). If a segment is missing from the at power-on (in the display segment test), or if strange characters appear instead of a proper blood glucose result, the display is malfunctioning. Please do not run any more blood tests; contact our Accu-Chek Blood Glucose

Meter Careline (please refer to Chapter 12:

“Customer support and service”). Do not re-use a test strip that has been completely ejected from the meter. Do not allow your Accu-Chek Compact meter to be used by more than one person. To do so would place all users at risk of infection (see

Chapter 7.2 “Cleaning the meter”).

Keep the test strip away from skin unless you are touching it against blood or control solution. Do not bend the test strip, or an error message will be displayed.

mmol/L

short display test

mmol/L

full display check

If you hold down the ON/OFF button for a few seconds when you turn the meter on, you can perform a full segment check.

Do this to verify that all of the display segments are properly displayed.

Retain the vial in which the test strip drums came until you have used up the last test strips. When performing a quality control test, refer to the list of expected values printed on the vial.

Accu-Chek Compact turns off automatically after 5 minutes of non-use. After a blood glucose test result has been displayed, the meter turns off automatically after

60 seconds.

Please dispose of used test strips with your regular household waste.

Important!

51

52

5.5

Testing conditions

To obtain reliable blood glucose test results, ensure the following conditions are met:

Temperature range

The test must be carried out at a temperature between plus 10°C and plus 40°C, because chemical reactions are affected by temperature. If the test is performed at a temperature outside this range, the test result may be incorrect. At ambient temperatures outside this range, the meter turns off automatically, or error messages or results are displayed together with the thermometer symbol. Do not make treatment decisions based on such results.

They are for reference only.

Humidity

Relative humidity must be below 85%. A sudden change in temperature can cause moisture to condense on or inside the meter. If this happens, do not turn the meter on. Wait until it is thoroughly dry again. Make sure that it returns to room temperature slowly.

Electromagnetic fields

Very strong electromagnetic fields may affect the meter’s performance. Such electromagnetic fields can occur in the open near transmitters (radio, television, CB stations and poorly suppressed electrical equipment). If this happens, the error message “Err” is displayed. Move the meter to a different location and repeat the test.

Interference from electromagnetic fields

53

6

Reviewing stored blood glucose results

54

Accu-Chek Compact stores up to 100 test results together with date and time. Any important information that was displayed along with the test result is saved as well. For instance, if the thermometer symbol was displayed as a warning during a test because the ambient temperature was too high or too low, this information is stored along with the test result.

MEMO button

With the meter turned off, press the MEMO button.

The meter turns on without advancing a test strip from the drum. The most recent test result and “MEMO” are displayed.

SET button

Press the SET button to move towards the

“oldest” result stored. Press the MEMO button to scroll forward to the “newest” result again.

You can hold down the buttons to scroll through your results more quickly.

ON/OFF button

Press the ON/OFF button to turn the meter off.

A test strip is not ejected.

55

6.1

Highest value, lowest value, average

Your meter can display the highest and lowest blood glucose results and the average of current test results.

Statistics are based on the test results stored for the last

7 days, as long as they were saved with date and time.

If more than 100 tests were carried out during this period, statistics will be based on the last 100.

MEMO button

Press the MEMO button to enter the memory mode.

The meter turns on without advancing a test strip from the drum.

56

MEMO button and SET button

Press the SET and MEMO buttons at the same time.

The average of your current test results are displayed, identified by an “A”.

MEMO button

Press the MEMO button again. The highest measured test result is displayed together with date and time.

MEMO button

Press the MEMO button again. The lowest measured test result is displayed together with date and time.

ON/OFF button

Press the ON/OFF button to turn the meter off.

A test strip is not ejected.

57

58

6.2

Downloading test results to a computer

The blood glucose test results stored in your meter can be downloaded to a computer. This way you can keep a permanent record of long-term trends in your blood glucose values.

To transfer stored blood glucose test results to a computer, you need the appropriate hardware and software for infrared data transfer (please call our

Accu-Chek Customer Careline

– see Chapter 12 for details).

12

Install the software according to the manufacturer’s instructions.

Locate the infrared interface on the

Accu-Chek Compact.

12

Position the infrared adaptor (available separately) less than 10 cm away, so the two infrared windows are pointing toward one another.

Press the SET button and MEMO button at the same time. The meter turns on without advancing a test strip from the drum. The meter automatically downloads all stored blood glucose test results to your computer.

Two arrows flash in the display during the download. Once downloading has finished, the meter turns off automatically. A message is displayed on the computer indicating that the data transfer is complete.

The computer turns Accu-Chek Compact off.

Infrared adaptor

Important!

If data transfer did not occur or was incomplete, the meter turns off automatically after 5 minutes. To make the most of the download feature, you must set the year, date and time in your meter.

59

7

Checking, cleaning and storing your meter

60

7.1

Checking the meter

To ensure reliable results, you must periodically check the performance of your

Accu-Chek Compact. Do this by running a quality control check using Compact Control

Solutions.

When should I check my Accu-Chek Compact system?

When you open a new pack of test strips.

After you have replaced the batteries.

If your meter flashes “CTRL”, indicating that a quality control test is required.

After you have cleaned your meter.

If your blood test does not agree with how you feel.

Running a quality control test

Press the ON/OFF button. The meter turns on and automatically advances a test strip.

Press the SET button. “CTRL” appears in the display (simultaneously with the hand symbol) and is automatically stored along with the result, to flag it in memory as a control test result.

Quality control checking

Wait for the hand symbol

and the blood drop

to flash in the display before you apply control solution.

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62

7.1

Checking the meter

Take a bottle of control solution and hold the dropper tip downwards until a hanging drop forms at its end. Gently touch the drop of control solution against the front edge of the test strip near the black notch until the meter beeps and appears in the display.

The meter runs a test, then displays the result and “CTRL”.

Refer to the table on the label of the vial the drum came in and determine if the value is within the expected range. If the result is outside this range, run another quality control check. If the result of the second test is outside the expected range as well, refer to the “Troubleshooting guide” in Chapter 10.

If you are unable to identify or eliminate the source of the problem, contact our

Accu-Chek Customer Careline

. Please see

Chapter 12 for details of customer support and service.

Important!

Control readings (identified by “CTRL”) are not used in statistical calculations.

63

7.2

Cleaning the meter

64

1

2

1

If the outside of your meter or the display are dirty, wipe them off with a slightly dampened cloth. If blood has entered the test strip guide, or if the message “OFF” is displayed, clean the meter as follows:

Remove the cover from the measurement optics by slightly squeezing it from both sides and lifting it

2

off.

Removing the optical system cover

65

7.2

Cleaning the meter

66

Clean the measurement optics carefully with a slightly dampened cotton swab or a soft, lint-free cloth.

Press the cover back on.

Cleaning the optical system

Please ensure that the optical system cover (see description of the meter’s parts on pages 2 and 3) is firmly in place when you take a reading.

Caution!

67

68

7.2

Cleaning the meter

A potential risk of infection exists.

Medical staff and other persons using

Accu-Chek Compact to test blood glucose from more than one patient must be aware that any item coming into contact with human blood is a potential source of infection. (Please see “Protection of Laboratory

Workers from Infectious Diseases Transmitted by Blood, Body Fluids, and Tissues”; Second

Edition, Tentative Guideline, 1991, Document

M29-T2, National Committee for Clinical

Laboratory Standards.)

If you use 70% alcohol or a strongly diluted rinsing solution in the medical environment, wipe these fluids off immediately after application. Do not use cleaning agents that contain acetic acid (vinegar) or scouring agents because they can damage the display and the measurement optics.

7.3

Storing the meter

With the batteries removed, the meter may be stored at between minus 40°C and plus 70°C.

Please refer to the test strip package insert for the temperature at which to keep the test strips.

Storing the meter

Do not store the meter at above plus 50°C when it contains batteries. At this temperature and above, the batteries could leak and damage the meter.

At temperatures below minus 10°C, the batteries do not have enough power to keep the internal clock functioning.

Store the meter in a dry place to keep it in good working condition.

Caution!

69

8

Technical data

70

Meter type

Test Principle

Humidity

Accu-Chek Compact

Determination of glucose in fresh capillary blood by reflectance photometry.

Measuring range

0.6 – 33.3 mmol/L

Sample size

Approx. 3 – 3.5 µL (millionths of a litre)

Measuring time

Approx. 15 seconds (depending on concentration)

System operating

plus 10°C to plus 40°C

conditions

Meter storage conditions

Without batteries and test strips: minus 40°C to plus 70°C

With batteries and test strips: plus 2°C to plus 30°C

With batteries but without test strips: minus 10°C to plus 50°C

Less than 85% relative humidity

Memory capacity

Dimensions

Weight

Display

Automatic power-off

Power supply

Battery life

Interface

Safety class

LED/IRED

100 test results with time and date, average, highest and lowest blood glucose readings

103 x 52 x 31 mm

Approx. 120 g with batteries and test strip drum

Liquid Crystal Display

(LCD) with symbols

After 60 seconds/5 minutes depending on testing status

2 batteries type AAA

At least 500 readings

Infrared interface

III

Laser Class 1

71

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9

Warranty

Manufacturer’s warranty:

As part of the Accu-Chek Commitment, Roche

Diagnostics warrants that the meter and lancing device shall be free from defects in material and workmanship under the terms as specified on the Warranty Card. Your statutory rights are not affected.

The meter and lancing device must have been subjected to normal use. No claim will be entertained if the meter or lancing device has been improperly handled, used or serviced, or has been tampered with.

We undertake to repair faulty components free of charge or, at our discretion, to provide a fault-free replacement meter.

Guarantee:

The manufacturer’s warranty is in addition to, and in no way affects, your statutory rights or any warranty claims you may have against the seller of the meter under the terms of your sales contract.

Be sure to fill out your warranty card that came with your Accu-Chek Compact system and return to Roche Diagnostics.

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10

Troubleshooting Guide

If your meter repeatedly displays error messages, if you have reason to doubt the validity of a test result, or if a quality control check returns a result that is outside the expected range (see Chapter 7.1), please check the following points:

Did you perform the test as directed? (see Chapter 5)

Is the optical system dirty? (see Chapter 7.2)

Do the batteries still have enough power? Are they properly inserted? (see Chapter 2)

Did you perform the test within the correct temperature range? (plus 10°C to plus 40°C)

Are the test strips beyond their expiration date?

(see test strip drum container)

Has the 3-month “use-by” period for the drum been exceeded? (see insert)

Have the proper storage conditions for the meter and test strip drum been observed?

(see Chapter 7.3 and the package insert that came with the test strip drum)

For quality control checks: Is the control solution beyond its expiry date?

(see label on bottle)

For quality control checks: Did you use the correct quality control solution?

(Compact Control)

If you have checked these points and still receive error messages or doubt the validity of results, please contact our

Accu-Chek

Customer Careline

.

Please see Chapter 12 for details of customer support and services.

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11

Display messages

When symbols and numbers are shown in purple below, it indicates that they flash in the meter`s display.

Display Cause

Meter will not turn on.

• Batteries are empty.

• Ambient temperature is too low.

• Display is damaged.

• Meter is defective.

Battery power is sufficient for a maximum of 50 more tests.

Battery symbol appears and disappears after

3 seconds.

Insufficient battery power — no further tests can be performed.

Clock has stopped.

Clock is slow after the meter is turned on.

The meter was exposed to temperatures below minus 10°C, and the batteries are starting to freeze.

Action

• Move the meter somewhere warmer and repeat the test.

• Contact our

Accu-Chek Customer Careline

(see Chapter 12 “Customer support and service”).

Continue testing until all the test strips in the test strip drum have been used. Then insert two new batteries (type AAA) and a new test strip drum.

Insert two new batteries (type AAA).

Always store the meter at above minus 10°C.

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11

Display messages

Display

mmol/L

Cause

Temperature was outside the indicated range during testing.

78

A dot appears in the control window at the back of the meter.

It is too warm or too cold for the test, i.e. warmer than plus

45°C or colder than plus 5°C.

There was not enough blood on the strip.

The test strip drum in the meter is empty.

Action

The displayed test result may only be used for reference purposes. It is saved along with the thermometer symbol. To perform an accurate test, let the meter and test strips slowly cool down or warm up, and repeat the test. The optimum measuring temperature is between plus 10°C and plus 40°C.

No test result is displayed or saved. Let the meter and test strips slowly cool down or warm up, and repeat the test. The optimum measuring temperature is between plus 10°C and plus 40°C.

Repeat the test with a larger drop of blood.

Insert a new drum.

If the message is still displayed, please call our

Accu-Chek Customer Careline

(see Chapter 12 “Customer support and service”).

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11

Display messages

Display Cause

The bar code information stored from the test strip drum has been lost.

There is no test strip drum in the meter.

You inserted a test strip drum that has already been used.

Action

Open the drum compartment and close it again.

Warning! The display showing the 90-day

“use-by” period will be lost (see Chapter 3).

Insert a test strip drum.

Warning!

The meter cannot determine how long the test strip drum has been outside the meter, or whether it is still usable. If you are certain that the

3-month “use-by” period has not been exceeded, you may continue to use the drum. Perform a quality control check. The result of the quality control check will be stored in memory along with

“CTRL”, and the drum symbol will remain displayed until a new drum is inserted. If you do not perform a quality control check, the flashing drum symbol and the flashing “CTRL” will appear with every new test until a new drum is inserted.

Until this point, all test results will be stored along with the flashing drum symbol and “CTRL”.

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11

Display messages

Display Cause

Drum symbol and “E-2” flash when the

first drum

from a new pack is inserted. During subsequent tests the drum symbol flashes.

The bar code on the drum is damaged.

Action

Remove the drum from the meter and return it to its vial. Insert the second drum from the package and use all 17 test strips. When it is time to replace the drum, insert the first drum with the damaged bar code. When the error message is displayed, press the SET button. The meter uses the code from the previous drum. “CTRL” flashes in the display, requesting you to perform a quality control check. You can use all 17 test strips. The drum symbol continues to flash in the display until a new drum is inserted.

All test strip drums in the same package have a bar code unique to that package.

Do not try to code the meter using drums from a different package. Check if you are using the correct drums by comparing their batch codes. The batch code is preceded by the symbol LOT . If the message is still displayed, please contact our Accu-Chek

Blood Glucose Meter Careline (see Chapter

12 “Customer support and service”).

Warning!

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11

Display messages

Display Cause

Drum symbol and “E-2” flash when the

second or third drum

of a package is inserted.

During subsequent tests the drum symbol flashes.

The bar code on the drum is damaged.

Action

Press the SET button. The meter uses the bar code from the first drum. The error message disappears. “CTRL” flashes in the display, requesting you to perform a quality control check. You can use all 17 test strips. The drum symbol continues to flash in the display until a new drum is inserted.

All test strip drums in the same package have a bar code unique to that package. Do not try to code the meter using drums from a different package. Check you are using the correct drums by comparing their batch

(or lot) codes. The batch code is preceded by the symbol LOT . If the message is still displayed, please contact our Accu-Chek

Blood Glucose Meter Careline (see Chapter

12 “Customer support and service”).

Warning!

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11

Display messages

Display Cause

or The 3-month “use-by” period has been exceeded.

The test strips in the drum are unusable.

When reviewing results: The test strips used to obtain the stored result were unusable (more than 3 months old).

Action

Insert a new drum.

If you continue to use the drum, carry out a quality control test. The test results obtained under these conditions may only be used for reference purposes. The error message continues to flash in the display until a new drum is inserted.

Warning!

The test results obtained under these conditions may only be used for reference purposes and must not be used for decisions regarding therapy.

Warning!

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11

Display messages

Display Cause

• A test error has occurred.

• There is electromagnetic interference.

• You forcibly removed the test strip during testing.

• You bent the strip while applying blood or during measurement.

• The optical system cover may not be closed properly.

The test strip is stuck in the guide.

Action

• Repeat the test.

• Move away from possible sources of interference (see Chapter 5.3

“Testing conditions”).

• Repeat the test with a new strip, this time ejecting it by means of the ON/OFF button.

• Repeat the test with a new strip.

• Ensure that the optical system cover is firmly in place.

Pull the strip out of the meter. Carefully open the drum compartment and remove the drum without turning it. Re-insert the drum. Close the drum compartment. Keep the “use-by” period in mind when reusing the drum.

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11

Display messages

Display Cause

• You touched the test strip against the blood drop too soon.

• The optical system is dirty.

• The test strips are too old.

• The meter was turned off and on again. The strip is still in the meter.

• You forcibly removed the test strip during testing.

The blood glucose result is above the upper limit of

33.3 mmol/L.

Action

• Turn the meter off and on again. Repeat the test.

Wait until the hand symbol has appeared in the display before touching the test strip against the blood drop.

• Clean the optical system and repeat the test.

• Insert a new test strip drum.

• Hold the meter upright and let the strip drop out, or remove the strip manually, even if it takes a small amount of force.

• Repeat the test with a new strip, this time ejecting it by means of the ON/OFF button.

If this test result agrees with the way you feel, follow your doctor’s advice. If the way you feel does not agree with this test result, please perform a quality control check with Compact Control solution and a new test strip.

Warning!

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11

Display messages

Display Cause

The blood glucose result is below the lower limit of

0.6 mmol/L.

92

The download symbols are not displayed,

Accu-Chek Compact is turned off after 5 minutes and the computer displays a downloadrelated error message.

• An error occurred while data was being downloaded.

• A bright light source is too close to the infrared adaptor or the meter.

• The meter and the infrared adaptor are too far away from one another or not correctly aligned.

• A computer software error occurred.

Action

If this test result agrees with the way you feel, follow your doctor’s advice. If the way you feel does not agree with this test result, please perform a quality control check with Compact Control solution and a new test strip.

Warning!

• Download the data again.

• Increase the distance from the light source.

• Decrease the distance between the two units to less than 10 cm. Make sure the two IR windows are pointing toward one another.

• Read the Manual for the download software.

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Display messages

Display Cause

• Electrostatic discharge

• Meter is defective.

Action

Switch meter off and then on again

Please contact our

Accu-Chek Customer Careline

(see Chapter 12 “Customer support and service”).

Important

Please note: Several messages may be displayed simultaneously.

A combination such as a thermometer, drum symbol, blood glucose result, date and

“CTRL” flashing means:

The temperature during measurement was outside the indicated range and the 90-day countdown period for the drum has ended.

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Customer support and service

Customer support:

If you have any questions on how to use your meter or lancing device, if any of the results you obtain seem implausible, or if you suspect the meter has a fault, please contact the

Accu-Chek Customer

Careline

.

Service:

Please note that any repair, adjustment, or other change of the meter must only be performed properly by persons who have been authorised by Roche Diagnostics. If you suspect that the meter has a fault, please start by contacting the

Accu-Chek Customer Careline

. Our staff will attempt to identify and solve your problem over the phone. Some problems, however, cannot be solved over the phone, in which case you will be asked to send your Accu-Chek Compact meter together with the test strips you used and (if applicable) the completed guarantee card to your

Customer Support Centre.

Roche Diagnostics Ltd,

Bell Lane, Lewes,

East Sussex, BN7 1LG,

UNITED KINGDOM

Freephone: 0800 701000

Freephone Rep. of Ireland: 1 800 709600

On packaging, on the type plate and in the User’s Manual you may encounter the following symbols, shown here with their meaning:

IVD

For in vitro diagnostic use

0088

This product fulfils the requirements of Directive

98/79/EC on in vitro diagnostic medical devices.

REF Catalogue number

Please read package insert

Manufactured by

Caution (refer to accompanying documents).

Please refer to safety-related notes in the manual accompanying this instrument.

Store at

Accu-Chek and Softclix are trademarks of a member of the Roche Group

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13

Components of the Accu-Chek Compact System

1 Accu-Chek Compact

2 Accu-Chek Softclix finger pricker

1

98

2

99

100

13

Components of the Accu-Chek Compact System

3

Vial (contains 1 test strip drum of 17 strips)

4

Compact Control Solution for checking the performance of your system

5

17 sterile Softclix lancets

6

Carrying case

3

5

6

4

101

102

G

J

F

H

I

A

B

C

D

E

14

About the Accu-Chek Softclix

A Cap

B Depth selection arrow

C Notch

D Protective cap

E Softclix lancet

F Lancet holder

G Semi-circular cutout

H Ejector

I Transparent release button

J Priming button

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15

Alphabetical index

104

B

Bar code

Batch code

Batteries, inserting or replacing

Battery types

Beep signal, enabling/disabling

Blood, dosing the strip

Blood, too little applied

C

Checking the meter

Cleaning, meter

Coding, test strip drum

Computer, downloading results to a

Control solution

Customer support

D

Date, setting the date

Display messages

Drum compartment

E

Electromagnetic fields

Expiration date, test strips

H

Humidity

Page

80-84

83

10-15

4, 13, 77

28-29

46-47

47, 78

60-63

64-68

6

58-59

50, 62

96

36-37

76-95

2, 16-25, 81, 89

53, 88

23

53

I

Infrared adaptor

Introduction

L

Lancing device

Lot code

M

Manufacturer’s guarantee

MEMO button

Meter, checking meter performance

Meter, cleaning the meter

Meter, description of

Meter, storing the meter

59, 92

6

7, 38-42, 47 see “batch”

72

2, 29, 54

60-63

64-68

2

69

O

ON/OFF button 2, 27, 31, 35, 45, 55, 61, 89, 91

Optical system

Optical system, cleaning the optical system

2

67

Optical system, opening the optical system 65

P

Performance, checking meter

Problem checklist

60-63

76

Q

Quality control test 25, 51, 61, 75, 87, 91

R

Results

Results, downloading to a computer

14, 24, 31, 45, 50, 54, 79, 87

58-59

Results, reviewing stored results

Results, transferring stored results

54

59

105

14

Alphabetical index

106

T

Technical data

Temperature range

Test strip drum, inserting or replacing

Test strip ejection

Testing blood glucose

Testing conditions

Troubleshooting guide

U

Use-by date, test strip drum

70

52, 74, 78

16

49

38

52

74

15, 25, 81, 86

V

Values, highest, lowest, average

W

Warnings

Warranty

Window, test strip drum

Y

Year, setting the year

56

8

72-73

4, 23

30

107