Accu‑Chek Active blood glucose meter Instructions for Use

Explanation of symbols On the packaging and on the type plate of the meter you may encounter the following symbols shown here with their meanings: Consult the instructions for use Caution (refer to accompanying documents). Please refer to safety-related notes in the manual accompanying this instrument. Store at Manufacturer Catalogue number

0088 This product fulfils the requirements of

Directive 98/79/EC on in vitro diagnostic medical devices. This product fulfils the legal requirements of the People’s Republic of China on the use of certain substances in electronic products.

The explanation of any other symbols can be found in the instructions/inserts, accompanying components within the packaging.

Lot number

IVD

For in vitro diagnostic use

Last update: 2008-05 2

Intended use

Intended use The Accu‑Chek Active blood glucose meter Meter for quantitative determination of blood glucose values in fresh capillary blood using Accu‑Chek Active test strips. Suitable for self-testing. The meter may be used by patients who test their own blood glucose as well as by healthcare professionals for monitoring patients’ blood glucose values. Visually impaired persons must not use the meter.

Healthcare professionals must also read the instructions in Chapter 10 “Testing blood glucose in more than one patient – Information for healthcare professionals”. Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition; CLSI document M29-A3, 2005).

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About these Instructions for use

About these Instructions for use Please read these Instructions for use carefully and completely before testing blood glucose for the first time. If you have any questions, please contact your customer support and service centre (see Chapter 17).

remember that, in order to keep your meter in tip-top condition, you need to comply with all instructions given in addition to following the correct operating procedures. The meter is a precision instrument. Improper handling can impair its operation.

These Instructions for use will help you get to know your new meter step by step. They will provide you with all the information you need to operate, troubleshoot and care for your meter. It is important to

We recommend you start by studying the location of the key features of your meter (see Chapter 1.1). Practise all of the operations described in these Instructions for use, and also practise testing.

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About these Instructions for use

In these Instructions for use you will come across three kinds of notes. Please read these very carefully. This symbol indicates a possible risk of injury or of damage to your own health or the health of others.

All instructions appear in a coloured frame as shown below: 1 Insert the test strip into the meter.

This symbol draws attention to actions that could result in damage to your meter.

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This symbol draws attention to important information.

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About these Instructions for use

In these Instructions for use you will see examples of display screens. Elements that are surrounded by a halo in these examples actually flash on the meter’s display.

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Please note: All dates, times or results shown on the display screens in these Instructions for use are intended only as examples. They show results in units of mmol/L (e.g. 7,1 mmol/L), dates in the day-month format (e.g. 18- 5) and times in the 24-hour clock (e.g. 15:27). Others can (and will) be shown on your meter’s display screen. Your meter can, for example, display results in mg/dL (e.g. 128 mg/dL), dates in the month-day format (e.g. 5-18) and times in the 12-hour clock (e.g. 3:27pm).

Contents

Contents 1

2

3

4

Getting to know your meter

12

1.1

Your meter at a glance... 12

1.2

The main features at a glance... 14

Steps before testing

16

2.1

Checking the contents... 16

2.2

Checking the unit of measurement for blood glucose... 17

2.3

Removing the protective film from the battery... 18

2.4

Performing a display check... 19

Setting the time and date

21

3.1

Overview... 22

3.2

Making settings... 24

Coding

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Contents

5

8

Testing blood glucose

30

5.1

Preparing to test blood glucose... 30

5.2

Testing blood glucose... 31 Turning the meter on... 31 Applying blood with the test strip in the meter... 34 Applying blood with the test strip outside the meter... 36 Turning the meter off... 39 Flagging test results... 40

5.3

Checking the test result using the test strip control window... 43

5.4

Symbols seen before, during or after testing and what they mean... 45

5.5

Notes on blood glucose testing... 46

5.6

Evaluating results... 49 Measuring range... 50 Implausible results – possible sources of error... 51

Contents

6

7

8

Using the meter as a diary

53

6.1

Memory... 53

6.2

Retrieving results from the memory... 54

6.3

Retrieving averages... 58

6.4

Downloading test results... 64 If downloading is unsuccessful... 69

Checking your meter

70

7.1

Preparing for a performance check... 71

7.2

Carrying out a performance check... 72

7.3

Possible sources of error during performance checks... 79

Cleaning the meter 8.1

82

External parts... 83

8.2 Test strip guide and measuring window... 83

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Contents

9

Changing the battery

10 Testing blood glucose in more than one patient – Information for healthcare professionals

87 91

10.1 Testing blood glucose... 93 10.2 Disinfecting the meter... 95 11 Measurement and storage conditions

96

11.1 Temperature... 96 11.2 Atmospheric humidity... 98 11.3 Light conditions... 98 11.4 Sources of interference... 99 12 Symbols, problems and error messages

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12.1 Symbols shown in the display... 101 12.2 Problems... 107 12.3 Error messages... 109

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Contents

13 Technical data

116

14 Disposing of your meter

121

15 System components

122

16 Patents

123

17 Customer support and service

124

17.1 Information service and troubleshooting... 124 17.2 Addresses... 124 18 Alphabetical index

127

11

Getting to know your meter

1

Getting to know your meter

1.1

Your meter at a glance 1 Display

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2 S button (retrieving settings for time and date) 3 Measuring window cover 4 Measuring window (underneath the cover) 1 7

6 M button (retrieving readings from the memory, changing time / date)

6

2

7 Code chip 8 Infrared window

5 3

4 12

5 Test strip guide

Getting to know your meter

9 Code chip slot 10 Code chip (inserted) 14

11 Type plate

13

12 Battery compartment

12

9 10 11

13 Battery (type CR 2032) 14 Locking catch for opening the battery compartment

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Getting to know your meter

1.2

The main features at a glance

 Fast testing The meter needs only approximately 5 seconds for each test.

 Flagging results You can flag results with different symbols, which indicate particular situations during the test.

 Easy testing For testing, you do not need to press a single button. You insert a test strip into the meter, which switches it on, apply blood to the test strip, read the value and then pull the test strip out of the meter.

 Memory The meter automatically saves up to 350 results with the time and date of the test and all other information that is important for the test.

 Blood volume checking To perform a test, the meter requires 1–2 µL blood (1 µL (microlitre) = 1 thousandth of a millilitre). The meter detects if the applied amount is not sufficient.

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 Integrated data analysis From the stored test results your meter can calculate your average values for the last 7, 14 or 30 days.

Getting to know your meter

 Data transfer The meter has an infrared port enabling you to download stored test results to a computer.  Applying blood outside the meter When the meter prompts you to apply blood, you can remove the test strip from the meter, apply the blood and insert it back into the meter.

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Steps before testing

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Steps before testing

2.1

Checking the contents

Check that the contents of the package are complete. You will find a list with the contents on the box. If anything is missing, please contact your customer support and service centre (see Chapter 17).

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Steps before testing

2.2

Checking the unit of measurement for blood glucose

Blood glucose results can be displayed in two different units (mmol/L or mg/dL). Two different versions of the same meter are therefore available. Please check if your meter displays the unit you are accustomed to.

You can find the unit of measurement that your meter displays on the type plate on the back of your meter. If you do not know which is the right unit for you, ask your doctor. The unit of measurement that your meter displays cannot be changed. If the wrong unit is printed on the type plate, please consult your dealer or pharmacy. A wrong unit of measurement could lead to test results being misinterpreted.

Type plate

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Steps before testing

2.3

Removing the protective film from the battery The meter is supplied with a battery inserted. The battery contacts are covered with a protective film to prevent the battery from becoming drained prematurely. Before using the meter, remove the protective film. You will see the film projecting from the battery compartment on the back of the meter. 1 Simply pull the film vertically out of the meter. You do not need to open the battery compartment to do this.

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For how to change the battery, see chapter 9.

Steps before testing

2.4

Performing a display check You can check if all of the display elements are properly displayed, by carrying out a full display check. 1 With the meter turned off, press the M and S buttons at the same time until the meter is switched on automatically (more than 3 seconds).

Press at the same time for more than 3 seconds

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Steps before testing

2 Compare the display of your meter with the one shown here.

mmol/L meter

mg/dL meter

If any of the display elements are missing or the unit shown for the blood glucose results is not the correct one, please ask your dealer/pharmacy to exchange the meter. 3 Press any button to terminate the display check and turn off the meter.

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