Roche Accu-Chek Active User Manual

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ONR 4285 – 4all 4468 V1/1 – man_cover_06658768001_02_EN_ Format 127 x 154 mm – Black (2013) Frau Ritzerfeld Prüfmittelnummer n/a R2/1 – man_cover_06658768001_02_EN_ Format 127 x 154 mm – Black

R2/2 – man_cover_06658768001_02_EN_ Format 127 x 154 mm – PMS 287 CVC

User’s Manual

Blood Glucose Meter

06658768001(02) – 2013‑09 M_Version01_Rev2

ACCU‑CHEK is a trademark of Roche.

Roche Diagnostics GmbH

Sandhofer Strasse 116 68305 Mannheim, Germany

www.accu‑chek.com

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This User’s Manual features three types of warning:

This symbol indicates a possible risk of injury or of damage to your own health or the health of others.

Explanation of symbols

Various symbols are featured on the packaging and type plate of the meter. Their meanings are as follows:

Symbol Meaning

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

This symbol draws your attention to important information.

M R L I

The explanation of any other symbols can be found in the instructions for use and inserts accompanying components within the packaging.

Consult instructions for use

Caution, refer to safety‑related notes in the instructions for use accompanying this product.

Biohazard risks – used meters carry a risk of infection.

Temperature limitation (store at)

Use by

Manufacturer

Catalogue number

Batch code

In vitro diagnostic medical device

This product fulﬁls the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices.

Last update: 2013‑08

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Contents

Intended use � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 2

About this User’s Manual � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 3

1 Getting to know the blood glucose monitoring system � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 4

2 Steps before testing � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 7

3 Changing settings � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 10

4 Testing blood glucose � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 16

5 Using the meter as a diary � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 30

6 Analysing test results on the PC � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 35

7 Checking your meter � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 38

8 Cleaning the meter � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 44

9 Changing the battery� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 46

10 Testing blood glucose in more than one patient � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 48

11 Test and storage conditions � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 50

12 Symbols, problems and error messages � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 52

13 Disposing of your meter � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 59

14 Technical data and system components � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 60

15 Customer Support and Service Centre � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 63

16 Alphabetical index � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 65

Explanation of symbols � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � III

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Intended use

The Accu-Chek Active blood glucose meter

The Accu‑Chek Active blood glucose meter is intended to be used for quantitative blood glucose tests in fresh capillary blood. The meter may only be used together with Accu‑Chek Active test strips. Consult the package insert of the test strips if you intend to use dierent sample material.

The blood glucose monitoring system comprises the meter and test strips and is suitable for self‑testing and for professional use. People with diabetes can use this system to self‑test their blood glucose. Healthcare professionals can use this system to check patients’ blood glucose values and they can use it in suspected cases of diabetes and in emergency diagnostics.

The system is suitable for testing blood glucose with blood obtained from alternative sites.

The system must not be used to diagnose or rule out diabetes.

The system is only suitable for use outside the body.

Visually impaired persons must not use the meter.

The meter must only be used for its intended purpose; if used otherwise preventive measures could be ineective.

• Healthcare professionals must also read the instructions and notes in Chapter 10 “Testing blood glucose in more than one patient”.

• All objects that could come into contact with human blood are potential sources of infection.

There is a risk of infections (e.g. hepatitis B, hepatitis C, HIV) being transmitted if the meter is used by other people, even family members, or if healthcare professionals use the same meter to test blood glucose in more than one person.

• Only use the Accu‑Chek Active meter with Accu‑Chek Active test strips that are approved by Roche Diagnostics. Other test strips deliver incorrect results.

• Keep the blood glucose monitoring system with all its components away from children under the age of 3. There is a risk of suocation if small parts (e.g. covers, caps or similar objects) are swallowed.

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About this User’s Manual

Read this User’s Manual 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 page 63).

This User’s Manual will provide you with all the information you need to operate, troubleshoot and care for your blood glucose meter. Follow the correct operating procedures for the meter and comply with all instructions for use. You can turn the beep tone of the meter on or o. This User’s Manual assumes that the beep is on.

Actions to be taken appear as shown in the example below:

Gently slide the test strip into the test strip guide in the direction of the arrow until you feel it lock into place.

The meter turns on and ﬁrst performs a default display check (approx. 2 seconds).

Title bar of the ﬁgure with a number or ﬁgure caption

Figure displaying actions to be taken

Action to be taken (blue text)

Information on action to be taken (black text)

Flashing elements

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

Please note: All dates, times or results shown on the display screens in this User’s Manual are intended only as examples.

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Getting to know the blood glucose monitoring system

The Accu-Chek Active blood glucose meter and its components

1. Display

displays the current and saved test results or device messages

2. Buttons

see “Buttons of the blood glucose meter” overview

3. Cover

covers the measurement window

4. Measurement window

underneath the cover

5. Test strip guide

slide the test strip in here

6. Locking catch

opens the battery compartment cover

7. USB port

the USB cable is inserted here in order to transfer data to a computer

8. Code chip

code chip inserted in the code chip slot

9. Battery compartment

right: open battery compartment, battery type CR2032

10. Type plate

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Getting to know the blood glucose monitoring system

Buttons of the blood glucose meter

Overview of the M and S button functions:

11. Test strip container

12. Test strip

13. Control solutions

14. Code chip

15. Battery

M button S button

Press the M button to Press the S button to

turn the meter on and call up saved values

mark the test result after a test mark the test result after a test

change settings go to the next setting

call up the previous saved test result

change from the earliest saved test result to the averages

call up the previous average call up the next average

Press the M and S buttons at the same time to

perform a display check

save settings after the ﬁnal display is shown on the display and turn the meter o

turn the meter o

Press the M or S button to

turn the test reminder beep o

turn the meter on and call up settings, e.g. for the time

call up the next saved test result

change from the averages to the saved test results

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Getting to know the blood glucose monitoring system

The main features

• Short testing time The meter needs only approximately 5 seconds for each test.

• Testing without pressing buttons For testing, you do not need to press a single button.

• Additional dosing option To perform a test, the meter requires 1–2 µL blood (1 µL (microlitre) = 1 thousandth of a millilitre). The meter detects if the amount of blood is insucient, and more blood can be applied.

• Marking test results You can mark test results with dierent symbols which indicate particular situations during the test.

• Memory The meter automatically saves up to 500 test results with the time and date of the test and all other information that is important for the test.

• Integrated data analysis From the stored test results your meter can calculate your average values for the last 7, 14, 30 and 90 days.

• Data transfer The meter has a USB port. You can transfer saved test results to a computer.

• Flexible blood application You can apply blood to the test strip while the test strip is in the meter or after you have removed it from the meter.

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Steps before testing

Unpacking 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 page 63).

Checking the unit of measurement

Test results can be displayed in two dierent units of measurement (mg/dL or mmol/L). Two dierent versions of the same meter are therefore available. Check if your meter displays the unit of measurement 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 professional.

. If you do not know which is the right unit for you, ask your healthcare

The unit of measurement that your meter displays cannot be changed. If the wrong unit of measurement is printed on the type plate, ask your healthcare professional to exchange the meter or contact your customer support and service centre. Using the wrong unit of measurement may cause

misinterpretation of your actual blood glucose level and may lead to improper therapy.

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Steps before testing

Checking the display

You can check if all of the display elements are properly displayed, by carrying out a full display check.

With the meter turned o, press the M and S buttons at the same time for approximately 2 seconds until the meter is switched on.

mg/dL meter mmol/L meter

Compare the elements displayed on your meter with the display shown here.

If any of the display elements are missing or the unit of measurement shown for the blood glucose results is not the correct one, please ask your healthcare professional to exchange the meter.

Press the M and S buttons at the same time to end the display check and turn the meter o.

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Steps before testing

Inserting the code chip

A code chip is used to give the meter information about the properties of the test strips. This is why each test strip box contains a code chip.

• Each time you open a new test strip box, you must replace the old code chip from the meter with the new one from the new test strip box. Code chips from other test strip boxes may contain information that is incorrect for your new test strips, and can therefore lead to incorrect test results. Incorrect test results can cause the wrong therapy recommendation to be made and so produce serious adverse health eects.

• If the code number on the display does not match the code number on the test strip container, do not perform blood glucose tests.

Compare the code number on the code chip with the corresponding code number on the label of the test strip container.

The three‑digit number on the code chip (e.g. 689) must match the three‑digit number on the label.

Leave the meter turned o.

Gently slide the code chip straight into the code chip slot on the side of the blood glucose meter.

You must feel the code chip lock into place.

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Changing settings

Overview

You can make changes to the meter settings for the time format, time, date and beep.

The meter is delivered with the date and time pre‑set. You may need to adjust the settings to your time zone. In order to analyse your saved test results properly, it is necessary to set the correct time and date.

Turning the meter on Changing settings

31 2

Press the S button for longer than 2 seconds.

The display above appears on the display.

When display, it is possible to make changes to the settings.

The setting which can be now changed begins to ﬂash.

You can now adjust the time format (24h or 12h).

appears on the

Press the M button.

The changed time format appears on the display.

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Changing settings

Go to the next setting Turning the meter o

Order of the settings

Time format

Time (hour)

Time (minute)

Year

Turning o

Date (month)

Press the M and S buttons brieﬂy at the same time.

Date (day)

When the ﬁnal display appears on the display, the modiﬁed settings are also saved.

Beep (on, o)

Final display

Press the S button brieﬂy to go to the next setting.

Press the S button repeatedly until the ﬁnal display appears on the display.

Only then will the modiﬁed settings be saved when you turn the meter o.

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If you do not press any buttons, the meter turns o automatically after approx. 30seconds. If you have not reached the ﬁnal display, all changes are lost and the original settings remain unchanged.

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Changing settings

Setting the time format

You can choose between two formats:

24-hour format Time from 0:00 to 23:59, date in the day‑month format (DD‑MM)

12-hour format

When you change the time format, the time and date are changed accordingly.

24-hour format 12-hour format

The time format ﬂashes on the display.

Time from 12:00 to 11:59 followed by am or pm, date in the month‑day format (MM‑DD)

Setting the time format

Press the M button brieﬂy to switch from one format to the other.

Press the S button. Next comes the time.

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Setting the time and date

24-hour format

Setting the hours

Changing settings

24-hour format

12-hour format

The hours ﬂash on the display.

24-hour format

12-hour format

The minutes ﬂash on the display.

Year

Press the M button to set the hours.

Setting the minutes�

Press the M button to set the minutes.

Setting the year

12-hour format

Press the S button. Next come the minutes.

24-hour format

12-hour format

Press the S button. Next comes the year.

Year

The year ﬂashes on the display.

Press the M button to set the year.

Press the S button. Next comes the month.

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Changing settings

24-hour format

12-hour format

The month ﬂashes on the display.

24-hour format

12-hour format

The day ﬂashes on the display.

Setting the month

Press the M button to set the month.

Setting the day

Press the M button to set the day.

24-hour format

12-hour format

Press the S button. Next comes the day.

24-hour format

12-hour format

Press the S button. Next comes the beep.

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Setting the beep

Beep is on

Turning the beep on or o

Changing settings

Beep is o

The beep symbol appears together with display.

(on) on the

Press the M button brieﬂy to turn the beep on or o.

Final display on the display

24-hour format 12-hour format

At the end of making settings, the meter displays the current settings.

Press the M and S buttons brieﬂy at the same time to turn the meter o.

The beep symbol appears together with display.

Press the S button. Next comes the ﬁnal display.

(o) on the

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Page 18

Testing blood glucose

Using the Accu‑Chek Active meter, you can test blood glucose in two dierent ways. You can either apply the blood drop to the test ﬁeld while the test strip is in the meter (see page 19), or you can remove the test strip from the meter and then apply the blood drop to the test ﬁeld (see page 20).

Please also consult “Notes on blood glucose testing” (see page 22).

Preparing to test blood glucose

You need the following items to carry out the blood glucose test:

• your meter with the code chip inserted

• the Accu‑Chek Active test strips that belong to the code chip

• a lancing device to obtain blood

• a lancet for the lancing device

Read the package insert which comes with the test strips.

Wash your hands thoroughly with soap and warm water and dry them well. This reduces contamination of the puncture site and stimulates blood ﬂow.

Prepare your lancing device to obtain blood.

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Testing blood glucose

Turning the meter on

mg/dL meter

Testing blood glucose

mmol/L meter

Take a test strip from the test strip container. Close the test strip container again immediately.

Hold the test strip so that the arrows printed on it and the green square face upwards.

Gently slide the test strip into the test strip guide in the direction of the arrows until you feel it lock into place.Do not bend the test strip.

The test strip must lie ﬂat on the measurement window cover.

The meter turns on and ﬁrst performs a default display check (approx. 2 seconds).

Check that all the segments of the numeric display meter) or well as the unit of measurement are displayed.

If segments are missing, please contact your customer support and service centre (see page 63).

(mmol/L meter) as

(mg/dL

Following the display check, the code number is displayed (689 is just an example).

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Page 20

Testing blood glucose

Check that this code number is the same as the code number on the label of the test strip container.

If the numbers do not match, even though the code chip in the meter belongs to the test strip container, please contact your customer support and service centre.

Following the code number, the test strip symbol and the ﬂashing blood drop symbol appear on the display. You now hear a beep.

The meter is now ready to perform a blood glucose test. You have approx. 90 seconds to apply blood to the test strip. After this time, the meter turns itself o.

If you missed the code number on the display after sliding in the test strip, remove the test strip from the meter and slide it in again.

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Page 21

Applying blood

With test strip in the meter

Testing blood glucose

mg/dL meter

mmol/L meter

Lance the side of a ﬁngertip with your lancing device.

Figure

shows the recommended sites for obtaining blood.

Encourage a blood drop to form by gently massaging the ﬁnger

towards the ﬁngertip (see

Apply the blood drop to the centre of the green ﬁeld and then remove your ﬁnger from the test strip.

As soon as the meter detects the blood, you hear a beep.

The test starts. The ﬂashing hourglass symbol

indicates

that the test is in progress.

The test is over in approximately 5seconds. The test result appears on the display and you hear a beep. The meter automatically saves the test result.

You can now mark the test result, set a test reminder or turn the meter o.

If the amount of blood you applied is insucient, after a few seconds an acoustic warning in the form of 3 beeps sounds. You can then apply an additional amount of blood.

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Page 22

Testing blood glucose

Applying blood

With test strip outside the meter

2 3

Lance the side of a ﬁngertip with your lancing device.

Figure recommended sites for obtaining blood.

Encourage a blood drop to form by gently massaging the ﬁnger towards the ﬁngertip (see

shows the

When the test strip and the ﬂashing blood drop symbols are displayed:

Remove the test strip from the meter.

The test strip and blood drop symbols ﬂash afterwards on the display. Now you have approx. 20 seconds to apply blood to the test strip and to slide it into the meter again. During the last 5 seconds, a beep sounds once per second. It is to remind you to slide the test strip with blood back into the meter. If you do not slide the test strip back into the meter within this time, the meter displays the error message

Apply the blood drop to the centre of the green ﬁeld.

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Page 23

Testing blood glucose

Turning the meter o

Gently slide the test strip into the test strip guide in the direction of the arrows until you feel it lock into place.

The test strip must lie ﬂat on the measurement window cover.

The test starts. The ﬂashing hourglass symbol indicates that the test is in progress.

mg/dL meter

mmol/L meter

The test is over in approximately 8 seconds. The test result appears on the display and you hear a beep. The meter automatically saves the result.

You can now mark the test result, set a test reminder or turn the meter o.

Turn o

Remove the test strip from the meter.

The meter turns itself o.

Discard used test strips according to local regulations. Healthcare professionals must discard used test strips according to the health and safety policy of their laboratory or institution.

If you do not remove the test strip and do not press any buttons, the meter turns o automatically after approx. 30seconds.

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Page 24

Testing blood glucose

Notes on blood glucose testing

Incorrect test results could lead to incorrect therapy recommendations resulting in serious adverse health eects. Therefore, follow the following instructions:

• Use only test strips which are within the use by date.

• The test strips are sensitive to humidity and moisture. Only remove test strips from the test strip container when your hands are completely dry. Close the test strip container again tightly with its original cap immediately after removing a test strip.

• If you have not applied blood to the test strip in the available time and the meter has turned itself o: Remove the test strip and discard it. Start the blood glucose test from the beginning with a new test strip.

• If an error message appears and you have not yet applied any blood, you must not use this test strip any more. Start the blood glucose test from the beginning with a new test strip.

• Do not rub the blood drop onto the test ﬁeld when applying blood.

• Do not store used test strips in a test strip container which still contains unused test strips.

• Do not bend the test strip while sliding it into the meter. The test strip must lie ﬂat on the measurement window cover.

• Do not to bend or move the test strip before or while applying blood, or while the test is in progress.

• Only apply blood to the test strip when the drop symbol is ﬂashing on the display.

or are not shown completely during the default display check (e.g. ), test results

• If cannot be displayed correctly. In this case, contact your customer support and service centre.

If you want to apply blood to a test strip which is not in the meter: Do not remove the test strip until the drop symbol ﬂashes on the display. If you remove the test strip before this time, the meter turns itself o.

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Page 25

Testing blood glucose

Marking test results

You can mark test results to describe certain events connected to the test result or particular characteristics of the test result. You can only mark a test result while the test strip is still in the meter and the test result is being displayed.

You can choose from 5 markers:

Symbol Meaning

Before meal (apple symbol): For test results from tests that you performed before your meals

After meal (apple core symbol): For test results from tests that you performed after your meals

Test reminder (apple + bell symbol): For test results from tests that you performed before your meals and which you would like to check 2 hours later. The meter reminds you to perform this test. The test result that you have marked with a test reminder is saved together with the

Other (asterisk symbol): You can deﬁne the meaning of this marker yourself (e.g. for test results from alternative sites or after physical activity).

Control (bottle symbol): For control tests in which you apply control solution to the test area instead of blood.

symbol.

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Page 26

Testing blood glucose

No marker

Control

Other

After meal

Before meal

Test reminder

As long as the test result is being displayed on the display, you can mark the test result.

Press the S button or M button repeatedly until the desired marker is displayed.

When you press the S button, the markers appear in the following order: 1 Before meal; 2 Test reminder; 3 After meal; 4 Other; 5Control.

The respective marker appears below on the display

When you press the M button, the markers appear in the reverse order.

If you decide to not mark the test result, press the S button or M button repeatedly until no further symbol is displayed.

mg/dL

meter

mmol/L meter

In the example above, the Before meal marker (

symbol) was

selected.

After choosing the desired marker, you can turn the meter o.

The test result is saved together with the marker.

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Page 27

Setting a test reminder

mg/dL

meter

mmol/L meter

As long as the test result is being displayed on the display, you can set a test reminder.

Press the S button or M button repeatedly until the Test reminder marker ( displayed.

The test result is saved together with the symbol

symbol) is

(Before meal).

Testing blood glucose

In two hours, you will be reminded to perform a blood glucose test. The ﬂashing symbol

appears on the display. At the same time, a beep sounds once per second.

You can now perform a blood glucose test.

Slide the test strip into the test strip guide and perform a blood glucose test.

As soon as you slide the test strip in, the test reminder is turned o.

The test result is saved together with the

If you decide not to perform a test, press the M button or S button to turn the test reminder o.

symbol (After meal).

If the meter is switched on at the time of the test reminder, the meter cancels the test reminder.

If you perform a blood glucose test up to 1 hour before a test reminder, the meter cancels the test reminder.

If you do not perform a blood glucose test at the time of the test reminder, you can still perform the blood glucose test within half an hour of the test reminder.

In both cases, the test result is saved together with the symbol (After meal).

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Page 28

Testing blood glucose

Checking your test results

The test strip itself allows you to estimate the test result through colour comparison and thus also to check the displayed result.

After the blood glucose test

The label on the test strip container shows blood glucose values in mg/dL and mmol/L next to each coloured dot.

Within 30 to 60 seconds after applying blood to the test strip, compare the colour of the control window on the back of the test strip with the dot that comes closest to your test result.

If the colour deviates signiﬁcantly, repeat the test. If the colour

Before the blood glucose test

On the back of the test strip, there is a round, coloured control window.

Compare the colour of this window with the coloured dots on the label of the test strip container.

The colour of the control window must match the colour of the top coloured dot (0 mg/dL, 0mmol/L). If the control window is a dierent colour, do not perform a test with that test strip.

deviates during further tests, contact your customer support and service centre.

Only the test results displayed by the meter should be used for therapeutic recommendations. The colour comparison serves only as a visual or sanity check of the test results.

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Page 29

Testing blood glucose

Symbols before, during or after a blood glucose test

The following symbols can appear on the display before, during or after a test. For further information, please refer to the “Symbols, problems and error messages” chapter (see page 52).

Symbol Meaning

The battery is almost empty.

The temperature during the test was outside the permitted range of +8 to +42°C.

Instead of a test result: The test result is lower than 10 mg/dL (0.6 mmol/L).

Instead of a test result: The test result is higher than 600 mg/dL (33.3 mmol/L).

The test strips are past their use by date.

The display may indicate that your blood glucose is very low (possibly a severe hypoglycaemia). The display

If the display professional immediately. If the display does not reﬂect the way you feel, perform a control test. Repeat the blood glucose test afterwards. If the new test result still does not reﬂect the way you feel, please contact your healthcare professional.

may indicate that your blood glucose is very high (possibly a severe hyperglycaemia).

or reﬂects the way you feel, follow the instructions given by your healthcare

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Page 30

Testing blood glucose

Evaluating test results

Blood glucose results are inﬂuenced, amongst others, by nutritional choices, medicine taken, state of health, stress and physical activity.

• Do not change your therapy without talking about it with your healthcare professional ﬁrst.

• If the blood glucose result is above or below the target range that you have set together with your healthcare professional, please contact your healthcare professional.

• If the test result reﬂects the way you feel, continue as instructed by your healthcare professional.

• If the test result does not reﬂect the way you feel, e.g. it is unexpectedly high or low, perform a control test. Repeat the blood glucose test afterwards. If the new test result still does not reﬂect the way you feel, please contact your healthcare professional.

• Please contact your healthcare professional immediately if your blood glucose values are too low or too high.

• If test results repeatedly do not reﬂect the way you feel, check the points in the following section “Sources of implausible test results”.

Sources of implausible test results

If your meter repeatedly displays error messages or implausible test results that do not reﬂect the way you feel, please check the following points. If your responses to the questions in the table are dierent from those given, make the respective corrections when you perform the next test.

If you have taken all of these points into account and still obtain implausible results or error messages, contact your customer support and service centre.

Did you use a test strip from the test strip container that has the same code number as the code chip in the meter?

Did you perform the test following the instructions in the User’s Manual? yes

Did you wash your hands thoroughly with soap and warm water and dry them well? yes

Did you use a used test strip? no

Did you apply blood after the beep sounded and the blood drop symbol began ﬂashing on the display?

man_06658768001_02_EN.indb 28 14.08.2013 10:18:24

yes

Page 31

Testing blood glucose

Did you bend the test strip while sliding it into the test strip guide on the meter? no

Did you apply the blood drop immediately after it had formed on your ﬁnger? yes

Did you bend or move the test strip before or during the test? no

Are the test strips past their use by date (check next to the container label and also the

Are the test strip guide and measurement window clean? yes

Did you perform the test within the correct temperature range (+8 to +42°C)? yes

Did you follow the storage conditions for the meter and the test strips? yes

Did you review the error messages that are referred to in the package insert that comes with the test strips?

If your meter has been dropped, it can no longer be certain that the meter is functioning properly.

Perform a control test. Repeat the blood glucose test afterwards.

symbol on your meter’s display)?

e symbol on the test strip

yes

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Page 32

Using the meter as a diary

The meter can save up to 500 test results with the time and the date and calculate averages from the saved test results. The meter automatically saves all test results. If the memory is full the oldest test result is deleted to create space for the new one, when you perform a new blood glucose test.

In addition to the test result, the time and date, your meter also saves all other information that is important for the test. This includes all symbols which are displayed after a blood glucose test with the test result (except the battery symbol) and the markers with which you marked the result.

Retrieving test results from the memory

mg/dL meter

mmol/L meter

No test results saved

With the meter turned o, press the M button brieﬂy (approximately 2 seconds) until the meter turns itself on.

The last (newest) test result is displayed together with the time, date and the word

If you marked the test result with a marker, the marker is also displayed.

If no test results are saved in the meter, the display above appears

on the screen.

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Page 33

In increasing order up to the oldest test result (memory location 500)

Order of the saved test results

mg/dL meter

mmol/L meter

Using the meter as a diary

to the averages

In decreasing order down

to the newest test result

(memory location 1)

Press the M button to retrieve the older test results. Press the S button to retrieve the saved test results in the reverse order.

As long as you press the M button or S button, the memory location number is displayed. When you release the button, the corresponding test result is displayed. If you keep the M button or S button pressed, the occupied memory locations are displayed in quick succession. Once you release the button, the corresponding test result is displayed.

When the oldest saved test result is displayed and you press the M button again, you hear a beep. When the newest saved test result is displayed and you press the S button again, you reach the averages (see next page).

You can switch directly from displaying any saved test result to performing a test by sliding a test strip into the test strip guide in the meter.

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Page 34

Using the meter as a diary

Retrieving averages

The averages calculated by the meter are calculated for 3 groups of test results and for 4 time periods per group. The meter calculates the averages in the following order:

Group Test results Period (days)

1 All test results 7 14 30 90

Only test results which have been marked with

meal)

Only test results which have been marked with

Results from control tests (marked with that were displayed as

With the meter turned o, press the M button brieﬂy (approximately 2 seconds).

The last saved (newest) test result is displayed.

or are not included in the calculation.

Press the S button brieﬂy.

The ﬁrst average, the 7‑day average of all test results, is displayed.

The upper left corner of the display shows the number of test results taken into account for calculating the average. The upper right corner of the display shows the number of days taken into account for calculating the average.

(Before

(After meal)

), test results without a valid date or time as well as test results

7 14 30 90

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Page 35

Order of the averages

(7, 14, 30, 90 = number of days taken into account)

All results

Using the meter as a diary

Before meal

mg/dL

meter

➞

Results marked with (Before meal)

➞

Results marked with (After meal)

➞

Press the S button to retrieve the averages in the order shown above. Press the M button to retrieve the averages in the reverse order.

If you press the S button repeatedly, the 14‑, 30‑ and 90‑day averages for all test results are displayed after the 7‑day average for all test results.

If you continue to press the S button, the averages for “Before meal” and “After meal” are displayed in the same order. When the last average is displayed (= 90‑day average marked with

) and you

press the S button again, you hear a beep.

If you keep the S button or M button pressed, the averages are displayed in quick succession.

mmol/L meter

“Before meal” averages are marked with

mg/dL

meter

After meal

mmol/L meter

“After meal” averages are marked with

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Page 36

Using the meter as a diary

Back

Turn o

No average

To go back to the saved test results:

Press the M button until a saved test result appears on the display.

The meter calculates the average for a period even when the saved test results cover a shorter period. For example: You only performed tests in the last 5 days. In this case, the test results of the last 5 days are used to calculate the averages for all four periods (7, 14, 30 and 90 days).

If you changed the date or time, performed a test and then re‑set the date or time, the chronological order of the test results is interrupted. As the meter can only calculate averages based on test results in an uninterrupted chronological order, it therefore does not take into account test results prior to the interruption.

You can switch from displaying any average to testing by sliding a test strip into the meter.

To turn the meter o:

Press the M button and S button at the same time.

If there are no test results saved for the selected average, three dashes are displayed.

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Page 37

Analysing test results on the PC

The meter has a built‑in USB (Universal Serial Bus) port for transferring saved test results to a computer (PC) that is equipped accordingly. Roche Diagnostics oers a variety of special diabetes management hardware and software products which enhance the integrated diary functions of your meter. With these hardware and software products, you and your healthcare professional can manage your test results more eectively and use graphs and tables to understand them better. For further information on diabetes management products, please contact your customer support and service centre.

USB port

The USB port 1 is located on the left side of the meter.

USB cable 1

To connect the meter to the computer, you need a maximum

1.5 m long USB cable with a Micro B connector and a USB‑A connector. Plug the Micro B connector of your meter. Plug the USB‑A connector your computer.

into the USB port

into a USB port of

Plug the Micro B connector into the USB port of your meter.

Plug the USB‑A connector into a USB port of your computer.

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Page 38

Analysing test results on the PC

2 3

If the meter is o, it is turned on when it gets connected to the computer.

Read the User’s Manual of the software in use. There you will ﬁnd all the information needed for data transfer.

If necessary, start the diabetes management software for test result analysis on your computer.

If no suitable software for test result analysis is installed on your computer, an error message may be displayed.

While the connection is being established, of the meter.

ﬂashes on the display

Once the connection to the computer has been successfully established, the meter transfers all saved test results.

During the data transfer, not ﬂash.

The test results remain in the meter’s memory after being transferred.

does

• If you already have a diabetes management product from Roche Diagnostics for transferring and evaluating test results, it may not recognise more recent meters and the results will therefore not be transferred. You may need a more recent version of your diabetes management software. In this case, contact your customer support and service centre.

• You cannot perform a test while test results are being transferred. You have to unplug the USB connector from the meter in order to perform a test.

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Page 39

Analysing test results on the PC

The meter is supplied with electricity via the USB cable while it is connected to the computer. Nonetheless, there must be a battery in the meter.

To turn the meter o, unplug the USB connector from the meter once the data transfer is complete.

For approximately 3 seconds,

is displayed.

The meter turns itself o.

If the transfer is unsuccessful

If the test results are not transferred ( is still ﬂashing on the display), the meter turns itself o automatically after approx. 90 seconds. There can be dierent reasons for a failed transfer. Eliminate the cause and start the transfer again.

Check

• if both USB connectors are properly inserted.

• if the USB cable is damaged (e.g. kinks in the cable).

• if all device drivers necessary for communication between the diabetes management software and the meter are installed.

• if your diabetes management software is compatible with the Continua standard. You can tell by this logo:

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Page 40

Checking your meter

You can check whether the meter provides accurate test results by performing a control test. To perform a control test, glucose control solution is applied to the test strip instead of blood.

Perform a control test using Accu‑Chek Active control solutions

• whenever you open a new test strip box,

• after you clean the test strip guide and the measurement window,

• if you are in doubt or concerned about a blood glucose result.

Please contact your customer support and service centre on where to obtain control solutions.

Preparing for a control test

For a control test, you need:

• the meter with the code chip inserted

• the Accu‑Chek Active test strips that belong to the code chip

• Accu‑Chek Active control solution Control 1 (low glucose concentration) or Control 2 (high glucose concentration)

• a clean, dry paper towel

• the concentration table for the control solutions (see label on the test strip container)

A control test is performed in the same way as a blood glucose test, except that you apply control solution to the test strip instead of blood and do not need to prick the ﬁnger.

Items required for a control test

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Page 41

Carrying out a control test

mg/dL meter

Checking your meter

2 3

mmol/L meter

Read the package insert which comes with the control solutions.

Remove a test strip from the test strip container and then close the cap tightly.

Hold the test strip so that the arrows printed on it and the green square face upwards.

Gently slide the test strip into the test strip guide in the direction of the arrows until you feel it lock into place.

The test strip must lie ﬂat on the measurement window cover.

The meter turns on and ﬁrst performs a default display check (approx. 2 seconds).

Check that all the segments of the numeric display meter) or well as the unit of measurement are displayed.

If segments are missing, please contact your customer support and service centre (see page 63).

(mmol/L meter) as

(mg/dL

Following the display check, the code number is displayed (689 is just an example).

Check that this code number is the same as the code number on the label of the test strip container.

If the numbers do not match, even though the code chip in the meter belongs to the test strip container, please contact your customer support and service centre.

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Page 42

Checking your meter

54 6

mmol/L

meter

mg/dL meter

When the ﬂashing blood drop is displayed on the display and the beep sounds, you have approx. 90seconds to apply control solution to the test strip.

Open a bottle of control solution.

Wipe the tip of the bottle with a clean, dry paper towel.

Hold the bottle downwards at an angle.

Squeeze it gently until a small drop of control solution which is free of any air bubbles is suspended from the tip of the bottle.

Apply 1 drop to the centre of the green ﬁeld without touching it with the tip of the bottle.

The ﬁeld must be completely covered with solution.

As soon as the meter detects the control solution, you hear a beep.

The test starts. The ﬂashing hourglass symbol indicates that the test is in progress. The test is complete after approx. 5 seconds and you hear a beep. The result of the control test appears on the display. The meter automatically saves the result.

To distinguish this control test from blood glucose results at a later date, you need to mark it as a control test.

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Page 43

mmol/L

meter

Checking your meter

7 8 9

These ﬁgures are only examples

Accu‑Chek® Active Control

Level mg/dL mmol/L

40-70 2�2-3�9

135-182 7�5-10�1

mg/dL meter

While the result of the control test is being displayed:

Press the M button brieﬂy once.

symbol for control is

The displayed (see also page 23, “Marking test results” section).

Control solution used

After marking the result as a control test:

Compare the result of the control test with the concentration table on the label of the test strip container.

Unit of measurement

Then remove the test strip from the meter.

The meter turns itself o.

Discard used test strips according to local regulations.

The test result must be within the speciﬁed concentration range.

Make sure that you compare the test result with the concentration data that corresponds to the relevant control solution used (1 or 2) and to the unit of measurement displayed by the meter (mg/dL or mmol/L).

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Page 44

Checking your meter

Sources of inaccurate control tests

If the result of the control test is outside the speciﬁed concentration range, repeat the control test. If the result of the second test is also outside the concentration range, check the following points.

If your responses to the questions below are dierent from those given, make the respective corrections when you perform the next test. If you have taken all of these points into account and the test results are still outside the speciﬁed concentration range, contact your customer support and service centre.

Did you use a test strip from the test strip container that has the same code number as the code chip in the meter?

Did you perform the control test following the instructions in the User’s Manual? yes

Did you use a used test strip? no

Did you wipe the tip of the bottle before you applied control solution to the test strip? yes

Did you apply a suspended drop of control solution? yes

Did you apply only one drop of control solution? yes

Were there air bubbles in the drop of control solution? no

Did you apply control solution after the beep sounded and the blood drop symbol began ﬂashing on the display?

Was the green ﬁeld completely covered with control solution? yes

Did you bend or move the test strip before or during the test? no

Did you perform the test within the correct temperature range (8–42°C)? yes

Did you compare the test result with the concentration range that corresponds to the control solution you used?

Is the concentration table on the test strip container from which you removed the test strip? yes

yes

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Page 45

Checking your meter

Are the test strip guide and measurement window clean? yes

Has the control solution been open for less than 3 months? Once opened, control solutions keep for only 3 months. They must not be used after this period.

yes

Have you read the section “Treating the control solutions properly” in the package insert for the control solution?

Did you follow the storage conditions for the meter, the test strips and the control solutions. (See chapter “Test and storage conditions” and the package inserts)?

Are the test strips or the control solution past their use by date? The use by date is printed next to the the label of the bottle next to the meter also displays the

symbol.

e symbol on the label of the test strip container or on

E symbol. If the use by date of the test strips has elapsed, the

If a control test produces results that are outside the speciﬁed concentration range, it is no longer certain that the meter and test strips are functioning properly. Blood glucose tests may then produce incorrect results.

Incorrect blood glucose results can cause the wrong therapy recommendation to be made and so produce serious adverse health eects.

yes

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Page 46

Cleaning the meter

If the meter is dirty, it may be necessary to clean it.

Healthcare professionals using the meter to test several patients’ blood glucose must also read the instructions on disinfection (see page 49).

• Use only cold water as a cleaning agent.

• Clean the meter using a lightly moistened cloth or a lightly moistened cotton swab.

• Do not spray anything onto the meter and do not immerse it in water.

Cleaning the outside

If the case of the meter or the display is dirty:

Wipe it using a cloth lightly moistened with cold water.

man_06658768001_02_EN.indb 44 14.08.2013 10:20:02

If the test strip guide is dirty or the

Remove the cover in the direction of the arrow.

Dab the cover and the test strip guide on the inside

outside

using a lightly moistened cloth or cotton swab.

Cleaning the test strip guide

error message is displayed:

and the

Page 47

Cleaning the measurement window

Cleaning the meter

CLICK

Carefully dab the measurement window and its surrounding area using a lightly moistened cloth or cotton swab.

• Make sure that no water enters the meter.

• Avoid scratching the measurement window.

Remove any ﬂu or lint that may remain.

Dry the areas you have cleaned thoroughly.

Place the cover straight and centred onto the meter.

Slide the cover closed. The cover must audibly CLICK into place.

In doing so, the guides on the inside of the cover and on the meter must be perfectly aligned.

Perform a control test (see page38).

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Page 48

Changing the battery

When the battery symbol appears on the display for the ﬁrst time, the battery is almost empty. You can perform approximately 50 more tests with the battery. Change the battery as soon as possible. The battery has already lost a lot of power and changeable conditions (e.g. a cold environment) can aect its performance even further.

You need 1 battery of the type CR2032.

With a new battery you can perform approx. 1000 tests or test for approx. 1 year.

When you change the battery, your saved test results always remain saved. Remove the used battery right before inserting the new battery into the meter so that the time and date settings are not lost.

1 3

The battery compartment is located on the back of the meter.

Push the locking catch downwards and remove the battery compartment cover.

+ symbol

facing

upwards

Remove the used battery. Place the new battery in the

compartment, with the + symbol facing upwards.

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Page 49

4 5

CLICK

Changing the battery

Never throw batteries into a ﬁre. They may explode.

Dispose of used batteries in an environmentally friendly way at a collection depot or follow local guidelines.*

* In Australia: Dispose of used batteries in line with local council regulations.

Place the battery compartment cover back on again. The two prongs on the lower edge must engage with the slots in the battery compartment.

man_06658768001_02_EN.indb 47 14.08.2013 10:20:21

Press the battery compartment cover closed. It will CLICK into place audibly.

Page 50

Testing blood glucose in more than one patient

Information for healthcare professionals

Only health care professionals are allowed to perform blood glucose tests, and nursing sta for inpatients and outpatients are allowed to perform blood glucose tests on more than one patient using the same Accu‑Chek Active meter.

Always follow the recognised procedures for handling objects that are potentially contaminated with human material for all steps involved in using the meter. Practise the health and safety policy of your laboratory or institution.

• Any patient with an infection or suering from an infectious disease and any patient who is a

carrier of a multi-resistant microorganism must be assigned his/her own meter. This also applies if it is suspected that a patient has one of the above. During this time the meter must not be used to test any other patient.

• Patients and medical sta are potentially at risk of becoming infected if the same Accu‑Chek Active meter is used to test blood glucose in more than one patient. All objects that come into contact with human blood are potential sources of infection.

• Residues of water or disinfectant on the skin can dilute the blood drop and so produce incorrect test results.

• Dispose of used lancets or single‑use lancing devices and used test strips according to the health and safety policy of your laboratory or institution.*

• Wear protective gloves.

• The patients hands should be washed with soap and warm water or cleaned with an alcohol wipe and dried thoroughly.

• Use only a lancing device approved for use by healthcare professionals. Observe the operating procedures in the respective User’s Manual.

• Apply blood to the test strip while it is outside the meter (see page 20, “Applying blood – With test strip outside the meter” section).

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Page 51

Testing blood glucose in more than one patient

Disinfecting the meter

The following parts of the meter may become contaminated:

• the case

• the cover

• the measurement window

The meter, the cover and the measurement window must be carefully cleaned and disinfected after every use (see the “Cleaning the meter” chapter, page 44). Remember to also clean recesses, grooves and gaps.

Cotton swabs, pads or cloths which are lightly moistened with 70% isopropanol are suitable for disinfecting.

1 2

Wipe the case of the meter with a cloth that is lightly moistened with 70 % isopropanol.

• Make sure that no liquid enters the meter.

• Do not spray anything onto the meter and do not immerse it in liquid.

Carefully dab the measurement window and its surrounding area as well as the cover from both sides using a lightly moistened cloth or cotton swab.

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Page 52

Test and storage conditions

So that the meter works reliably and you obtain accurate test results, make sure that the following conditions are met.

Temperature

• For blood glucose tests and control tests the temperature must be between +8 and +42°C.

• If the temperature is at the limits of the permitted range (between +5 and +8°C or between +42 and +45°C), the meter still allows you to perform a test. The thermometer symbol will, however, be displayed (see also page 53).

• Tests cannot be performed at temperatures below +5°C and above +45°C. In this case the following appears on the display:

• Keep the meter without battery at a temperature between ‑25 and +70°C.

• Keep the meter with battery at a temperature between ‑20 and +50°C.

Atmospheric humidity

Only perform blood glucose tests and control tests when relative atmospheric humidity is below 85%.

Keep the meter below 93% relative atmospheric humidity.

• Do not use test results obtained at the limits of the permitted temperature range as a basis for making therapeutic decisions. These test results could be incorrect. Incorrect results can cause the wrong therapy recommendation to be made and so produce serious adverse health eects.

• Never try to speed up warming or cooling of the meter, e.g. in a refrigerator or on a radiator.

• At temperatures above +50°C the battery could leak and damage the meter.

• At temperatures below ‑20°C the battery does not have enough power to keep the internal clock functioning.

Sudden changes in temperature cause condensation to form in or on the meter. If this has occurred, do not turn the meter on. Let the meter slowly cool down or warm up at ambient temperature. Never keep the meter in a moisture‑prone area (e.g. a bathroom).

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Test and storage conditions

Light conditions

Do not perform a test when the meter and the test strips are exposed to direct sunlight. Go to a shaded place or shade the meter, for example with your body.

If the meter is exposed to too much light, the meter does not allow any tests to be performed. In this case the following error message appears on the display:

Sources of environmental interference

Do not use the meter in close proximity to a strong electromagnetic ﬁeld.

Avoid sudden changes in light conditions while testing. The ﬂash of a camera, for example, can lead to incorrect test results.

Keep the meter away from very strong light sources (e.g. direct sunlight). These may stop the meter from functioning correctly and lead to error messages.

• Strong electromagnetic ﬁelds may interfere with the proper operation of the meter.

• To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present.

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Symbols, problems and error messages

In addition to test results, time and date, other symbols and error messages also appear in your meter’s display. The following provides an overview of all symbols and error messages. Please pay attention to all symbols and error messages when you use the meter. If you do not recognise a symbol or do not understand an error message, please refer to this chapter for an explanation.

Symbols

Symbols on the display

1 2 3

17 16

14 13 12

5 6

7 8

Symbol Meaning

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You are in the test‑result memory. Either a saved test result or an average is being displayed.

The battery is almost empty.

When the symbol ﬁrst appears, you can perform approx. 50 more tests.

You are in the settings for the time format, time, date and beep.

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Symbol Meaning

Symbols, problems and error messages

When an average is displayed (memory): the symbol is preceded by the number of days taken into account.

Together with error message E‑5: The meter is exposed to too much light.

Flashing – A test is in progress or an average is being calculated.

The beep is turned on.

The unit your meter uses to display test results, either mg/dL or mmol/L depending on the meter.

The test strips are past their use by date. Change the test strips and code chip.

Flashing blood drop symbol – Now you can apply blood or control solution to the test strip.

Flashing blood drop and test strip symbol – The test strip was removed from the meter before blood or control solution was applied, for example to apply blood outside the meter.

The code number is being displayed. There is a problem with the code chip (see error message E‑3 or E‑6).

Test reminder together with the symbol for a blood glucose test after a meal.

“Before meal” or “After meal” marker

“Other” marker

Marker for control tests

At the time of testing, the temperature is or was between +5 and +8°C or between +42 and +45°C (see page 50).

Additional time information if 12‑hour time format is set.

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Symbols, problems and error messages

Symbols appearing in the numeric ﬁeld

mg/dL meter

mmol/L meter

Symbol Meaning

• The code chip has not been correctly inserted into the meter. Remove the code chip and re‑insert it.

• There is no code chip in the meter. Insert the code chip that belongs to the Accu‑Chek Active test strips you are currently using.

Averages cannot be calculated because

• you have not set the time and date,

• only test results without a time and date are saved,

• only test results that are not included in the calculation are saved, e.g. results from control tests,

• no test results were saved in the period in question, e.g. all test results in memory are more than 7 days old,

• the chronological order of the test results in the memory has been interrupted.

No test results have been saved.

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Symbols, problems and error messages

Symbol Meaning

The test result has been lost from memory.

Decimal point:

displayed by mmol/L meters and is part of the test result (e.g. 8.2 mmol/L is displayed as

The meter is connected to a computer (PC).

The meter has been disconnected from the computer (PC).

The test result is higher than 600 mg/dL (33.3 mmol/L).

The test result is lower than 10 mg/dL (0.6 mmol/L).

The display may indicate that your blood glucose value is very low (possibly a severe hypoglycaemia). The display severe hyperglycaemia).

or display reﬂects the way you feel, continue as instructed by your healthcare professional.

If the If the display does not reﬂect the way you feel, perform a control test. Repeat the blood glucose test afterwards. If the new test result still does not reﬂect the way you feel, please contact your healthcare professional.

may indicate that your blood glucose value is very high (possibly a

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Symbols, problems and error messages

Problems

Problem Cause and solution

The meter will not turn on. • The battery is empty or there is no battery in the meter.

Insert a new battery.

• You have inserted the battery the wrong way round.

Remove the battery and place it in the battery compartment as shown on page 46.

• The ambient temperature is low.

Ensure that the ambient temperature is between +8 and +42°C and wait for the meter to warm up to this temperature.

• The electronics have become damp through condensation.

Allow the meter to dry slowly.

• The meter is defective.

Please contact your customer support and service centre.

The time is shown as 0:00 or 0:00am and the date as 0‑ 0.

• The meter was exposed to a temperature below ‑20°C and the battery is beginning to freeze.

Turn the meter o. Ensure that the ambient temperature is between +8 and +42°C and wait for the meter to adapt to that temperature.

• The meter was without a power supply for too long.

Insert a new battery and set the time and date.

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Symbols, problems and error messages

Error messages

When an error occurs, an error message appears on the display and two beeps sound. Turn the meter o. Depending on the situation, either brieﬂy press the M button and S button or remove the test strip from the meter to turn the meter o.

If your meter has been dropped, this can also lead to error messages. If error messages occur frequently, contact your customer support and service centre.

Error message Cause and solution

• You did not slide the test strip in correctly or completely.

Hold the test strip so that the arrows printed on it and the green square face upwards. Without bending it, gently slide the test strip into the test strip guide in the direction of the arrows. You must feel the test strip lock into place.

• You slid a used test strip into the meter.

• You applied blood or control solution to the test strip too soon, i.e. before the drop symbol ﬂashed on the display.

Start the blood glucose test from the beginning with a new test strip.

• The measurement window is dirty.

Clean the measurement window (see page 44).

• Your blood glucose value may be very low.

If you have typical symptoms of a very low blood glucose, immediately follow your healthcare professional’s instructions for such cases. Repeat the test afterwards.

• You removed the test strip from the meter in order to apply blood and did not slide it back in it within 20 seconds.

• The test strip was bent or moved while testing was in progress.

• You applied too little blood or control solution to the test strip.

• You waited too long before applying a second drop of blood or control solution.

Start the blood glucose test from the beginning with a new test strip.

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Symbols, problems and error messages

Error message Cause and solution

• The code chip cannot be read.

Remove the code chip and re‑insert it into the meter.

• The incorrect code chip is currently in the meter.

Remove the code chip and insert the code chip that belongs to the Accu‑Chek Active test strips you are currently using.

• While the test was in progress, you connected the meter to a computer that was on.

Remove the USB cable and repeat the test.

• The meter was exposed to a strong electromagnetic ﬁeld.

Change your position or turn the source of electromagnetic radiation o.

• The meter is exposed to too much light.

Go to a shaded place or shade the meter, for example with your body.

• You removed the code chip while testing was in progress.

Re‑insert the code chip into the meter. Repeat the test with a new test strip.

• A meter error has occurred.

Start again from the beginning. If the error message appears again, the meter is defective. Please contact your customer support and service centre.

• The ambient temperature or the temperature of the meter is too low or too high for a test.

Ensure that the ambient temperature is between +8 and +42°C and wait for the meter to adapt to that temperature.

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Disposing of your meter

During blood glucose testing the meter may come into contact with blood. Used meters therefore carry a risk of infection. After having removed the battery, please dispose of your used meter according to the regulations applicable in your country. For information about correct disposal, please contact your local council or authority.

Healthcare professionals must dispose of used meters according to the health and safety policy of their laboratory or institution.

The meter falls outside the scope of the European Directive 2002/96/EC (Directive on waste electrical and electronic equipment).

j Dispose of the battery in an environmentally friendly way at a collection depot or follow local

guidelines.*

* In Australia: Dispose of used batteries in line with local council regulations.

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Technical data and system components

Technical data

Meter type

Catalogue no./Serial no.

Test principle Determination of glucose in fresh capillary blood by reﬂectance photometry. If

Measuring interval

Blood volume

Measuring time approx. 5 seconds if you apply blood while the test strip is in the meter

Power supply

Battery life

Automatic power-o

Memory

Temperature during testing: +8 to +42°C

Atmospheric humidity

Accu‑Chek Active (Model GU)

See type plate on the back of the meter

using other sample material, please refer to the package insert that comes with the Accu‑Chek Active test strips.

Blood glucose values (glucose concentrations) can be tested in whole blood or plasma. Although you always apply whole blood to the test strip, the blood glucose values displayed by your meter correspond to those in plasma. You will ﬁnd information on how the system works, on the test principle and on reference methods in the Accu‑Chek Active test strip package insert.

10–600 mg/dL (0.6–33.3 mmol/L)

1–2 µL (1 µL (microlitre) = 1 thousandth of a millilitre)

(depends on the concentration); approx. 8 seconds if you remove the test strip from the meter and then apply blood (depends on the concentration)

1 battery (type CR2032)

approx. 1000 tests or approx. 1 year

after 30 or 90 seconds depending on operating status

500 test results with time and date, as well as 7, 14, 30 and 90 day averages

during storage without battery: ‑25 to +70°C

during storage with battery: ‑20 to +50°C

during testing: up to 85% relative humidity

during storage: up to 93% relative humidity

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Technical data and system components

Altitude

Dimensions

Weight without battery: approx. 46 g

Display

Interface

Safety class

Electromagnetic compatibility

Performance analysis

Calibration and traceability

sea level to 4000 m

97.8 × 46.8 × 19.1 mm

with battery: approx. 50 g

96‑segment liquid crystal display (LCD)

USB (Micro B)

III

This blood glucose meter meets the electromagnetic immunity requirements as per EN 61326‑2‑6 and EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000‑4‑2.

In addition, it meets the electromagnetic emissions requirements as per EN 61326‑2‑6 and EN ISO 15197 Annex A. Its electromagnetic emission is thus low. Interference on other electrically‑driven equipment is not anticipated.

The performance data for the Accu‑Chek Active system (Accu‑Chek Active meter with Accu‑Chek Active test strips) was obtained using capillary blood from diabetic patients (method comparison, accuracy), venous blood (repeatability) and control solution (reproducibility).

The system (meter and test strips) is calibrated with venous blood containing various glucose concentrations. The glucose values used as reference values, and thereby also as accuracy values of this calibration, are obtained using the hexokinase method. The hexokinase method is calibrated using the ID‑GCMS method, which is the method of highest metrological quality (order) and is traceable to a primary NIST standard. As the test results obtained using these test strips can be traced back to the NIST standard using a traceability chain, the test results obtained with these test strips for control solutions can also be traced back to the NIST standard. This ensures that the metrological traceability of the control solutions refers to higher order reference materials/ reference methods.

The Accu‑Chek Active system meets the EN ISO 15197 requirements.

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Technical data and system components

System components

The Accu‑Chek Active blood glucose monitoring system comprises the following components in addition to the meter:

Accu-Chek Active test strips

Use only these test strips when you test blood glucose using the Accu‑Chek Active meter.

Accu-Chek Active control solutions

Use only these control solutions when you carry out control tests using the Accu‑Chek Active meter and the respective test strips.

Please ask your customer support and service centre where you can obtain test strips and control solutions.

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Customer Support and Service Centre

Information service and troubleshooting

For questions on how to operate your Accu‑Chek Active meter, or regarding implausible test results, or if you suspect the meter or test strips to be defective, contact your Roche Diagnostics customer support and service centre. Do not attempt to repair or modify the meter yourself. Our sta will help you solve any problems you might be experiencing with the meter or test strips from Roche Diagnostics. For the customer support and service addresses, see the next section.

Addresses

Australia

Roche Diagnostics Australia Pty. Ltd. 31 Victoria Avenue, Castle Hill NSW 2154, Australia ABN 29 003 001 205 Accu‑Chek Enquiry Line: 1800 251 816 www.accu‑chek.com.au For training videos, visit www.youtube.com/accuchek

Egypt

Diabetes Care Egypt 6, Ibn Arhab St. Giza, Egypt www.accu‑chekarabia.com

India

Roche Diagnostics India Pvt. Ltd. Plot No. 114, Road No. 15 MIDC, Andheri (E) Mumbai‑400093 www.accu‑chek.in india.accu‑chek@roche.com Customer Helpline: 1800 22 60 20* or 30 300 400** *Toll free lines for MTNL & BSNL User

**Preﬁx with STD code of your area & local call charges apply Working Hours: Monday to Saturday from 9.30 AM to

5.30 PM SMS HELP to 5757535

Indonesia

PT. Roche Indonesia Divisi Diagnostik Gedung Artha Graha, Lantai 21 Sudirman Central Business District ‑ Lot 25 Jl. Jend. Sudirman Kav. 52 – 53 Jakarta 12190 Hotline: 0‑800‑1‑222‑999 www.roche.co.id

Islamic Republic of Pakistan

Roche Pakistan Ltd. 37 ‑ C, Block 6 P.E.C.H.S. P.O. BOX 20021 Karachi – 75400

Jordan

Promotional Oce Levante Nabih Nabulsi Drugstores Prince Shaker Ben Zeid Street Shmeisani P.O.Box 1066 11118 AMMAN http://www.accu‑chekarabia. com

Malaysia

Roche Diagnostics (M) Sdn Bhd 2A, Jalan 13/1 46200 Petaling Jaya Selangor Darul Ehsan Toll‑Free Line: 1‑800‑88‑1313

Philippines

Roche (Philippines) Inc. Diagnostics Division 2252 Don Chino Roces Ave. 1231 Makati City Customer contact number, Assist : +63 2 89308000

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Hong Kong

Roche Diagnostics (Hong Kong) Limited Level 17, Tower 1, Metroplaza 223 Hing Fong Road, Kwai Chung New Territories Enquiry hotline: +852‑2485 7512 (oce hours) www.accu‑chek.com.hk

Singapore

Roche Diagnostics Asia Paciﬁc Pte. Ltd. 298 Tiong Bahru Road #11‑01 Central Plaza Singapore, 168730 Accu‑Chek ExtraCare line: 6272 9200 www.accu‑chek.com.sg

South Africa

Roche Products (Pty) Ltd. Diagnostics Division 9 Will Scarlet Road, Ferndale P.O. Box 1927, Randburg 2125 Accu‑Chek Customer Care Centre: 080‑DIABETES (Dial 080‑34‑22‑38‑37) www.diabetes.co.za

Customer Support and Service Centre

Thailand

Roche Diagnostics (Thailand) Ltd 18th Floor, Rasa Tower 555 Phaholyothin Road, Chatuchak Chatuchak, Bangkok 10900 Customer Service Line: +66 (0) 2791 2222

United Arab Emirates

Roche Diagnostics Regional Oce GCC P.O. Box 71437 Abu Dhabi www.accu‑chekarabia.com

United Kingdom

Roche Diagnostics Limited Charles Avenue, Burgess Hill West Sussex, RH15 9RY, United Kingdom Accu‑Chek Customer Careline UK Freephone number: 0800 701 000 ROI Freephone number: 1 800 709 600

calls may be recorded for training purposes www.accu‑chek.co.uk

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Index

alternative sites 23 apple core (symbol) 23 apple (symbol) 23, 53 applying blood 19, 20, 22 asterisk (symbol) 23, 53 atmospheric humidity 50, 60 averages 32 ave (symbol) 32, 53

battery (symbol) 27, 46, 52 beep 53 bell (symbol) 23, 53 bottle (symbol) 23, 53

changing settings 10 changing the battery 46 clean 44 code chip 4, 5, 9, 58 code number 9, 17, 53 code (symbol) 53, 58 concentration table 41 control solution 5, 38 control test 23, 38 control window 26 customer support and service

centre 63

data transfer 36 day (symbol) 32, 53 diabetes management 35 discarding test strips 21, 41 disinfection 49

display 4 display check 8, 17 drop (symbol) 18, 53

electromagnetic ﬁeld 51, 58, 61 error messages 57 exp (symbol) 29, 53

Hi (display) 27, 55 hourglass (Symbol) 19, 53

intended use 2

light conditions 51 Lo (display) 27, 55

marking, test result 23 measuring interval 60 memory 30, 60 memory (symbol) 30, 52 meter

checking 38 disinfecting 49 disposing 59

PC (display) 36 performing a test 17 problems 56 professionals 48

risk of infection 2, 48, 59

Index

sources of error

control test 42

testing blood glucose 28 storage conditions 50 sun (symbol) 53, 58 symbols (display) 52 system components 62

technical data 60 temperature 27, 50 test conditions 50 testing 16 testing blood glucose 16 test strip (symbol) 18, 20, 53 thermometer (symbol) 27, 53 turning o 5, 11, 34 turning on 5, 10, 17 type plate 7

unit of measurement (mg/dL,

mmol/L) 7, 53 USB cable 35 USB port 4, 35 use by date 27, 43, 53

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Roche Accu-Chek Active User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual