Blood Glucose Meter 0 5241430001(02) – 2008-05 Instructions for use 0088 ACCU-CHEK is a trademark of Roche. Roche Diagnostics GmbH 68298 Mannheim, Germany www.accu-chek.
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.
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.
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.
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. i This symbol draws attention to important information.
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. 6 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 mg/dL (e.g. 128 mg/dL), dates in the day-month format (e.g. 18- 5) and times in the 24-hour clock (e.g. 15:27).
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...........................................................................................................
Contents 5 8 Testing blood glucose 30 5.1 Preparing to test blood glucose...................................................................................................... 30 5.2 Testing blood glucose..................................................................................................................... Turning the meter on............................................................................................................... Applying blood with the test strip in the meter...
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.
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.......................
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....................................................................................................................................
Getting to know your meter 1 Getting to know your meter 1.
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 13
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.
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.
Steps before testing 2 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).
Steps before testing 2.2 Checking the unit of measurement for blood glucose Blood glucose results can be displayed in two different units (mg/dL or mmol/L). 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.
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.
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).
Steps before testing 2 Compare the display of your meter with the one shown here. mg/dL meter mmol/L 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.
Setting the time and date 3 Setting the time and date The time and date is not preset in new meters. You can still, perform blood glucose tests. In this case, however, the meter displays the time 0:00 (0:00am) and the date 0- 0. This means that test results are saved without a time and date. Averages cannot be calculated, and when downloaded to a computer, the statistical evaluation of test results is very restricted or cannot be performed at all.
Setting the time and date 3.1 Overview Turning the meter on Press the S button and hold it down (for more than 3 seconds) until the depicted display appears. When set-up appears in the display, you can make changes to the time and date. Press for more than 3 seconds Changing settings Press the M button. Holding down the M button increases the number quickly. For a detailed description of how to set the time and date, see Chapter 3.2.
Setting the time and date Confirming the change and continuing with the next setting Time and date format Time (hour, minute) Press the S button briefly. Year Date (month, day) Final display Turning the meter off at any time Press the M and S buttons briefly at the same time. First confirm your last change with the S button, since the change will otherwise be lost. Press briefly at the same time If you do not press any buttons, the meter turns off automatically after approx. 30 seconds.
Setting the time and date 3.2 Making settings Setting the time and date format You can choose between two formats: 24-hour format 35 time from 0:00 to 23:59, date in the day-month format (DD-MM) 12-hour format 35 time from 12:00 to 11:59 followed by am or pm, date in the month-day format (MM-DD) When you change the time and date format, the time and date are changed accordingly. 1 Press the M button briefly to switch from one format to the other. 2 Press the S button to go to the time.
Setting the time and date Setting the time The hours flash in the upper left corner of the display. 1 Press the M button to set the hours. 2 Press the S button to go to the minutes. The minutes flash in the display. 3 Press the M button to set the minutes. 4 Press the S button to go to the year.
Setting the time and date Setting the year The year flashes in the upper right corner of the display. 1 Press the M button to set the year. 2 Press the S button to go to the month. Setting the date The month flashes in the upper right corner of the display. 1 Press the M button to set the month. 2 Press the S button to go to the day.
Setting the time and date The day flashes in the display. 3 Press the M button to set the day. 4 Press the S button, and you will see the final display. Final display 1 Check that time and date are correct. 2 Press any button to turn off the meter.
Coding 4 Coding A code chip is used to give the meter information about the properties of the test strips. This is why each pack of test strips contains a code chip. 28 Each time you open a new pack of test strips, you must replace the old code chip from the meter with the new one from the pack. Code chips from other packs may contain information that is incorrect for your new test strips, and can therefore lead to incorrect test results.
Coding 1 Compare the code number on the 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 off. 2 Gently slide the code chip into the slot on the side of the meter. You must feel the code chip lock into place.
Testing blood glucose 5 Testing blood glucose Please also consult the directions given at the end of this Chapter in the section “Notes on blood glucose testing”. 5.1 Preparing to test blood glucose You need the following items to carry out the test: your meter with the code chip inserted the pack of Accu‑Chek Active test strips that belong to the code chip a lancing device to collect blood a lancet for the lancing device 30 1 Read the package insert which came with the test strips.
Testing blood glucose 5.2 Testing blood glucose Turning the meter on 1 Take a test strip from the container and close the container again immediately. 2 Hold the test strip so the arrows printed on it and the orange square face upwards. 3 Without bending it, gently push the test strip into the test strip guide in the direction of the arrows. You should feel the test strip lock into place.
Testing blood glucose The meter turns on and first performs a default display check (approx. 2 seconds). 4 Check that all the segments of the numeric (mg/dL meter) or (mmol/L display meter) are displayed. mg/dL meter mmol/L meter If segments are missing, please contact your customer support and service centre (see Chapter 17). Following the display check, the code number is displayed (689 is just an example).
Testing blood glucose 5 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 is the one that 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 appear on the display. The meter is now ready to perform a blood glucose test.
Testing blood glucose Applying blood with the test strip in the meter When the test strip and the flashing blood drop symbols are displayed, you have approx. 90 seconds to apply blood to the test strip. After this the meter turns itself off. 1 Prick the side of a fingertip with your lancing device. 2 Encourage a drop of blood to form by gently massaging your finger towards the fingertip. 3 Apply the drop of blood to the centre of the orange field and then remove your finger from the test strip.
Testing blood glucose The flashing hourglass symbol test is in progress. indicates that the The test is complete after approx. 5 seconds and the result appears on the display. The meter automatically saves the result. Now you can turn the meter off (see “Turning the meter off”), or flag the result (see “Flagging test results”), or go to the saved test results (see Chapter 6.1).
Testing blood glucose Applying blood with the test strip outside the meter When the test strip and the flashing blood drop symbols are displayed: 1 Remove the test strip from the meter. The test strip and blood drop symbols flash in the display. Now you have approx. 20 seconds to apply blood to the test strip and to re-insert it into the meter. If you do not re-insert the test strip within this .
Testing blood glucose 2 Prick the side of a fingertip with your lancing device. 3 Encourage a drop of blood to form by gently massaging your finger towards the fingertip. 4 Apply the drop of blood to the centre of the orange field. 5 Push the test strip back into the test strip guide in the direction of the arrows. You should feel the test strip lock into place.
Testing blood glucose The test starts and the flashing hourglass symbol indicates that the test is in progress. The test is complete after approx. 10 seconds and the result appears on the display. The meter automatically saves the result. Now you can turn the meter off (see “Turning the meter off”), or flag the result (see “Flagging test results”), or go to the saved test results (see Chapter 6.1).
Testing blood glucose Turning the meter off 1 Remove the test strip from the meter. The meter turns itself off. You can dispose of used test strips in your household waste. If you do not remove the test strip and do not press any buttons, the meter turns off automatically after approx. 30 seconds.
Testing blood glucose Flagging test results You can flag test results to describe certain events connected to the result or particular characteristics of the result. You can only flag a test result while the test strip is still in the meter and the result is being displayed. The General flag (asterisk symbol ): You can define the meaning of this flag yourself. For example, you can, use it for test results that you have obtained from alternative sites or after physical activities.
Testing blood glucose No flag While the test result is displayed: 1 Press the S button repeatedly until the desired flag is displayed. Control (bottle) Before meals (apple) The flags appear in the following order: 1. Before meals 2. After meals 3. General Press briefly General (asterisk) 4. Control After meals (apple core) If you decide to not flag the test result, press the S button repeatedly until no further symbol is displayed.
Testing blood glucose After choosing the desired flag, you can turn the meter off (see “Turning the meter off”), or go to the saved test results (see Chapter 6.1). In both cases, the test result is saved with the flag.
Testing blood glucose 5.3 Checking the test result using the test strip control window The test strip itself allows you to estimate the test result and thus also to check the displayed result. Before the test There is a round coloured control window on the back of the test strip. 1 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).
Testing blood glucose After the test The label on the test strip container shows blood glucose values in mg/dL und mmol/L next to each colour sample. 1 Look for the value which is closest to your test result. Within 30–60 seconds after applying blood: 2 Compare the colour of the control window on the back of the test strip with the coloured dots on the label of the test strip container. 44 If you find there is a noticeable disparity, repeat the test.
Testing blood glucose 5.4 Symbols seen before, during or after testing and what they mean The following symbols can appear on the disply before, during or after a test. For further information, please refer to Chapter 12.1. instead of a result: The result is lower than 10 mg/dL (0.6 mmol/L). may indicate that your blood glucose is very low (possibly a severe hypoglycemia). Follow the relevant instructions given by your doctor immediately and repeat the test.
Testing blood glucose 5.5 Notes on blood glucose testing Incorrect results can cause the wrong therapy recommendation to be made and so lead to serious adverse health effects. Therefore, please follow the following instructions: Only use the Accu‑Chek Active meter with Accu‑Chek Active test strips that are approved by Roche Diagnostics GmbH. Other test strips deliver incorrect results.
Testing blood glucose The test strips are sensitive to humidity and moisture. Only remove test strips from the container when your hands are completely dry. Close the test strip container again tightly with its original cap immediately after removing a test strip. The cap of the test strip container contains a drying agent which protects the strips from moisture.
Testing blood glucose You can touch the test field when you apply blood, but do not rub the drop of blood into the test field. Please also note the following points, as incorrect results or error messages can otherwise occur: Do not store used test strips in a container which still contains unused test strips. This could make the unused test strips unusable. Unusable test strips can lead to incorrect results. Do not bend the test strip while inserting it into the meter.
Testing blood glucose 5.6 i Further information If you missed the code number in the display after you inserted the test strip, remove it from the meter and re-insert it. If you want to apply blood to a test strip which is not inserted into the meter: Do not remove the test strip until the drop symbol flashes in the display. If you remove the test strip before this time, the meter turns itself off.
Testing blood glucose Measuring range The meter measures blood glucose results in the range from 10 to 600 mg/dL (0.6–33.3 mmol/L). If the result is lower than 10 mg/dL (0.6 mmol/L), is displayed instead of a result. may indicate that your blood glucose is very low (possibly a severe hypoglycemia). Follow your doctor’s instructions immediately and repeat the test. If the result is higher than 600 mg/dL (33.3 mmol/L), is displayed instead of a result. Repeat the test.
Testing blood glucose Implausible results – possible sources of error If your meter repeatedly displays implausible results or error messages, please check the following points. If your responses to the questions listed below are different 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.
Testing blood glucose Did you bend the test strip while inserting it into the meter? no Is the test strip guide and measuring window yes clean? Did you wait for the drop symbol to flash in the display before applying blood? yes Did you measure within the correct temperature range (10–40 °C)? yes Did you apply the drop of blood immediately after it formed? yes Did you bend or move the test strip before or during the test? yes no Did you observe the storage conditions for the meter and test strip
Using the meter as a diary 6 Using the meter as a diary 6.1 Memory Your meter can save up to 350 test results with their time and date. You do not need to do anything to save the results. The meter automatically saves all test results. In addition to the results, the time and the date, your meter also saves other information that is important for the test. This includes all symbols which are displayed with the result (except the battery symbol) and the flags with which you marked the results.
Using the meter as a diary 6.2 Retrieving results from the memory 1 With the meter turned off, press the M button. You can also go directly to the saved results after a test. To do so, press the M button while the result is displayed. Press briefly The last saved (latest) result is displayed with the .
Using the meter as a diary Retrieving older results: 2 Press the S button. While you press the S button, the memory location number is displayed. When you release the button, the corresponding result is displayed. If you keep the S button pressed, the occupied memory locations are displayed in quick succession. Once you release the button, the corresponding result is displayed. After the oldest result in the memory, the latest result is displayed again.
Using the meter as a diary Turning the meter off again: 3 Press the M button briefly. You can directly switch from the saved results to the test by inserting a test strip into the meter.
Using the meter as a diary If there are no results saved in the meter, the display shown next to this text appears. No result in the memory If the time and date were not set at the time of testing, 0:00 and 0- 0 are displayed instead.
Using the meter as a diary 6.3 Retrieving averages The meter can calculate averages from the saved results. The averages are calculated for three groups of results and for three time periods per group. The calculation is performed in the following order: 1. All results 1. for the last 7 days 2. for the last 14 days 3. for the last 30 days 2. Only results which have been flagged with (Before Meals) 1. for the last 7 days 2. for the last 14 days 3. for the last 30 days 58 3.
Using the meter as a diary 1 With the meter turned off, press the M button briefly. You can also briefly press the M button directly after a test while the result is being displayed. Press briefly The last saved (latest) result is displayed together .
Using the meter as a diary 2 Press the M and S buttons briefly at the same time. You can not only call up the averages from within the last saved result, but also from within each saved result. Press briefly at the same time The first average, the 7-day average of all results, is displayed. The number of days taken into account for the calculation of the average is displayed in the upper right corner of the display.
Using the meter as a diary To go the next average: Order of the averages (7, 14, 30 = number of days taken into account) all results 7 ➞ 14 ➞ Results flagged with (Before Meals) 30 ➞ 7 ➞ 14 ➞ 30 Results flagged with (After Meals) ➞ 7 ➞ 14 ➞ 30 3 Press the M and S buttons briefly at the same time. The averages are displayed in the order shown next to this text. Averages “before meals” are flagged with . Averages “after meals” are flagged with .
Using the meter as a diary From within each average you can either go back to the saved results or turn the meter off. Go back to saved results 4 Press the S button briefly to go back to the saved results. Press briefly The result which was shown before the average was calculated is displayed again. or Or: turn the meter off. 4 Press the M button briefly to turn the meter off.
Using the meter as a diary If there are no results saved for the selected average, are displayed. three dashes The meter calculates the average for a period even when the saved results cover a shorter period. For example: Tests were only performed in the last 5 days. In this case, the results of the last 5 days are used to calculate the averages for all three periods (7, 14 and 30 days).
Using the meter as a diary 6.4 Downloading test results Your meter has a built-in infrared port which enables wireless data downloading to a suitably equipped computer or handheld device (PDA), or to a special analysis system. The infrared port is located at the front of the meter. Infrared port 64 Roche Diagnostics offers a variety of special hardware and software products for analysing your data and which enhances the integrated notebook functions of your meter.
Using the meter as a diary Depending on which type of analysis you opt for, you will require either a special software programme and/ or special hardware products. For more information please contact your customer support and service centre. please contact your customer support and service centre. If you already have a hardware or software product from Roche Diagnostics for transfering and evaluating test results, it may not recognise more recent meters and the results will therefore not be downloaded.
Using the meter as a diary 1 Read the operating instructions supplied with the software and hardware you are using. There you will find all the information needed for downloading data. 2 Prepare the receiving end (software product or hardware) for downloading the test results. 3 With the meter turned off, press and hold the M button (for more than 3 seconds) until flashes in the display.
Using the meter as a diary 4 Place the meter approx. 5-20 cm away from the infrared port of the receiving end. Position the two infrared ports so that they are facing towards one another. 5–20 cm 5 If necessary, start the test result download at the receiving end (software product or hardware). The meter automatically downloads all of the results from its memory. While the data is downloaded, does not flash.
Using the meter as a diary If the meter was not turned off automatically by the receiving end when the download was completed, is displayed. 6 Press the M button briefly to turn the meter off.
Using the meter as a diary If downloading is unsuccessful If the results are not downloaded ( is still flashing in the display), the meter turns off automatically after approx. 90 seconds. There can be different reasons for a failed download. Eliminate the cause and start the download again. The infrared ports are too far apart or not properly facing one another. Reduce the distance between the two infrared ports to 5-20 cm and position them so they are facing one another.
Checking your meter 7 Checking your meter You can check whether the meter provides correct results. To perform this performance check, a glucose control solution is applied to the test strip instead of blood. Perform a performance check using Accu‑Chek Active control solutions, Also read the instrcutions in Chapter 5.
Checking your meter 7.
Checking your meter 7.2 Carrying out a performance check 1 Read the package insert which came with the control solutions. 2 Take a test strip from the test strip container and close it again immediately. 3 Hold the test strip so that the arrows printed on it and the orange square face upwards. 4 Without bending it, gently push the test strip into the test strip guide in the direction of the arrows until you feel it lock into place.
Checking your meter The meter turns on and first performs a default display check (approx. 2 seconds). 5 Check that all the segments of the numeric (mg/dL meter) or (mmol/L display meter) are displayed. mg/dL meter mmol/L meter If segments are missing, please contact your customer support and service centre (see Chapter 17). Following the display check, the code number is displayed (689 is just an example).
Checking your meter 6 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 in the display. Now you have approx. 90 seconds to apply control solution to the test strip.
Checking your meter 7 Open a bottle of control solution. 8 Wipe the tip of the dropper with a clean, dry paper towel to remove any dried-on residues. 9 Invert the bottle and hold it downwards at an angle. Squeeze it gently until a small drop which is free of any air bubbles is suspended from the tip. 10 Apply one drop to the centre of the orange field without touching it with the tip of the dropper. The field must be completely covered with solution.
Checking your meter The flashing hourglass symbol indicates that the test is in progress. The test is complete after approx. 5 seconds and the result appears on the display. The meter automatically saves the result. To distinguish this performance check from blood glucose test results at a later date, you need to flag it as a performance check. No flag Control (bottle) While the test result is displayed: 11 Press the S button briefly 4 times.
Checking your meter After flagging the result as a performance check: Accu‑Chek® Active Control mg/dL mmol/L 1 2 37 – 67 2,1 – 3,7 134 – 181 7,4 – 10,0 Figures are examples Control solution used Unit of measurement 12 Compare the test result with the concentration table on the label attached to the test strip container. The result must be within the specified concentration range.
Checking your meter 13 Then remove the test strip from the meter. The meter turns itself off. You can dispose of used test strips in your household waste.
Checking your meter 7.3 Possible sources of error during performance checks If the result is outside the specified concentration range, repeat the performance check. If the result of the second check is also outside the concentration range, please check the following points. If your responses to the questions below are different from those given, make the respective corrections when you perform the next test.
Checking your meter Did you take the test strip from the container yes which the code chip in the meter belongs to? Did you apply a suspended drop of control solution? yes Did you perform the performance check according to the instructions for use? yes Did you apply only one drop of control solution? yes Did you bend the test strip while inserting it into the meter? no Were there air bubbles in the drop? no Did you use a used test strip? no Did you wait for the drop symbol to flash in the disp
Checking your meter Did you compare the test result with the concentration data that corresponds to the control solution you used? yes Is the concentration table on the test strip container from which you removed the test strip? yes Is the test strip guide and measuring window yes clean? Has the control solution been open for less than 3 months? Once opened, control solutions are stable for only 3 months and must not be used after this period.
Cleaning the meter 8 Cleaning the meter You may need to clean the meter if it becomes dirty through improper use. Healthcare professionals using the meter to test several patients’ blood glucose must also read the instructions on disinfection in Chapter 10.2. 82 Use only cold water or 70 % ethanol to clean the meter. Any other cleaning agents may damage the meter or impair its measuring function. Use a lightly moistened cloth or a lightly moistened cotton swab.
Cleaning the meter 8.1 External parts If the case of the meter or the display is dirty: 1 Wipe away any dirt using a cloth lightly moistened with cold water or 70 % ethanol. 8.2 Test strip guide and measuring window You only need to clean the test strip guide and measuring window if you notice that the test strip guide or the measuring window located beneath the cover are visibly dirty, if the error message or is displayed. A dirty measuring window may be the cause.
Cleaning the meter 1 Pull the cover of the measuring window straight towards you. 2 Wipe the cover and the test strip guide from the outside and the inside using a lightly moistened cloth or cotton swab.
Cleaning the meter 3 Carefully wipe the measuring window and its surrounding area using a lightly moistened cloth or a cotton swab. Make sure that no liquid enters the meter. Avoid scratching the measuring window, as doing so could impair its measuring function. 4 Remove any fluff or lint that may remain. 5 Allow areas you have wiped time to dry thoroughly.
Cleaning the meter 6 Place the cover straight and centred onto the meter. 7 Slide it closed until it audibly clicks into place. In doing so, the guides on the inside of the cover and on the meter must be perfectly aligned. 8 Carry out a performance check (see Chapter 7).
Changing the battery 9 Changing the battery When the battery symbol appears in the display for the first time, the battery is almost empty. You can perform approximately 50 more tests with the battery. We recommend that you replace the battery as soon as possible. By then it will have lost a lot of power and changeable conditions (e.g. a cold environment) can affect its performance even further. When you change the battery, your results always remain saved.
Changing the battery The battery compartment is located on the back of the meter. 1 Push the locking catch downwards and remove the battery compartment cover. 2 Remove the used battery.
Changing the battery 3 Place the new battery in the compartment, with the + symbol facing upwards. 4 Re-attach the battery compartment cover so the two prongs on its lower edge engage with the slots in the battery compartment.
Changing the battery 5 Press the cover closed. It will click into place audibly. Never throw batteries into a fire. They may explode. 90 i Dispose of used batteries in an environmentally friendly way at a collection depot or through your dealer. i Remove the battery if you will not be using the meter for a longer period of time.
Testing blood glucose in more than one patient – Information for healthcare professionals 10 Testing blood glucose in more than one patient – Information for health‑ care professionals Only staff working in doctors’ practices, hospitals and diabetes training centres, and nurses are allowed to perform blood glucose tests on more than one patient using the same Accu‑Chek Active meter.
Testing blood glucose in more than one patient – Information for healthcare professionals Patients and medical staff are potentially at risk of becoming infected if the same Accu‑Chek Active meter is used to test blood glucose in several patients.
Testing blood glucose in more than one patient – Information for healthcare professionals 10.1 Testing blood glucose 1 Wear protective gloves. 2 The patient’s hands should be washed with warm water and soap and then dried well. If you are using alcohol wipes, the finger must also be completely dry. On dry skin the drop of blood cannot spread so easily. 3 Use only lancing devices approved for use by healthcare professionals. 4 Use a lancing device with adjustable penetration depth settings.
Testing blood glucose in more than one patient – Information for healthcare professionals 9 Encourage a drop of blood to form by gently massaging the finger towards the fingertip. A proper drop of blood must form. 10 Apply the drop of blood to the test strip. We recommend that you apply the blood to the test strip while it is outside the meter (see Chapter 5.2, section “Applying blood with the test strip outside the meter”).
Testing blood glucose in more than one patient – Information for healthcare professionals 10.2 Disinfecting the meter The following parts of the meter may become contaminated: the case Use a mixture of 1-propanol, 2-propanol and glutaraldehyde, known in some countries under the brand Bacillol plus. the measuring window cover Allow areas you have wiped time to dry thoroughly. the measuring window Make sure that no liquid enters the meter.
Measurement and storage conditions 11 Measurement and storage conditions So that the meter works reliably and you obtain accurate results, make sure that the conditions listed on the following pages are met. 11.1 Temperature For blood glucose tests and performance checks the temperature must be between +10 and +40 °C. If the temperature is at the limits of the permitted range (between +5 and +10 °C or between +40 and +45 °C), you can still perform a test.
Measurement and storage conditions Tests cannot be performed at temperatures below +5 °C and above +45 °C. In this case the following appears in the display: tion to be made and so lead to serious adverse health effects. Keep the meter without battery at a temperature between -25 and +70 °C. Keep the meter with battery at a temperature between -10 and +50 °C. At temperatures above +50 °C the battery could leak and damage the meter. Never try to speed up warming or cooling of the meter, e.g.
Measurement and storage conditions 11.2 Atmospheric humidity 11.3 Light conditions Only test blood glucose when atmospheric humidity is below 85 %. 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. Keep the meter below 93 % atmospheric humidity. Sudden changes in temperature cause condensation to form in or on the meter. If this has occurred, do not turn the meter on.
Measurement and storage conditions 11.4 Sources of interference Avoid sudden changes in light conditions while testing. The flashlight of a camera, for example, can lead to incorrect results. Keep the meter away from very strong light sources (e.g. direct sunlight, studio lighting, etc.). 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.
Symbols, problems and error messages 12 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. Some of the screens that you see in normal use have already been explained in previous chapters. 100 On the following pages you will find a complete overview of symbols and error messages, what they mean and what actions you should take. Please pay attention to all symbols and messages when you use the meter.
Symbols, problems and error messages 12.1 Symbols shown in the display 1 2 3 1 You are in the test-result memory. Either a saved test result or an average is being displayed. 17 2 4 The battery is almost empty. 5 16 6 15 7 8 14 13 12 18 When the symbol first appears in the display, you can perform approx. 50 more tests. When the battery is so low that no more tests can be performed, the meter turns itself off immediately.
Symbols, problems and error messages 3 7 You are in the settings for time and date. 4 When an average is displayed (test-result memory): the symbol is preceded by the number of days taken into account. 5 (flashing) The meter is exposed to too much light. 6 (flashing) A test is in progress or an average is being calculated. 102 General flag 8 or The unit your meter uses to display the blood glucose result, either mg/dL or mmol/L. 9 + 10 The test strips are past their expiry date.
Symbols, problems and error messages 10 + 11 11 (flashing) The test strip was removed from the meter before blood or control solution was applied, for example to apply blood outside the meter. (flashing) Now you can apply blood or control solution to the test strip. 12 The number being displayed is the code number. (flashing) together with 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.
Symbols, problems and error messages Do not use the result as a basis for therapeutic decisions. Ensure that the ambient temperature is between +10 and +40 °C and wait for the meter to adapt to that temperature. Repeat the test with a new test strip. 16 Flag for performance check 17 Additional time information if 12-hour time format is set.
Symbols, problems and error messages together with : 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 performance checks, no test results were saved in the period in question, e.g. all results in memory are more than 7 days old, you changed the time and date and then performed a test.
Symbols, problems and error messages The result is higher than 600 mg/dL (33.3 mmol/L). Repeat the test. Decimal point: displayed by mmol/L meters and is part of the result (e.g. 8.2 mmol/L is displayed as ). together with : No results have been saved. together with : The result has been lost from memory. 106 (flashing) You have turned the meter on to download test results. The meter is downloading test results. The meter has finished downloading test results.
Symbols, problems and error messages 12.2 Problems The meter will not turn on. You have not removed the protective film from the battery. Remove the film from the battery (see Chapter 2.3). 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 specified. The ambient temperature is low and the battery is almost empty.
Symbols, problems and error messages The meter is turned on, but the display is blank. The display is defective. Please contact your customer support and service centre. The clock has stopped or the clock is slow. The meter was exposed to a temperature below -10 °C and the battery is beginning to freeze. Turn the meter off. Ensure that the ambient temperature is between +10 and +40 °C and wait for the meter to adapt to that temperature. 108 The time is shown as 0:00 or 0:00am and the date as 0- 0.
Symbols, problems and error messages 12.3 Error messages If an error message is displayed, turn the meter off. Depending on the situation, either by briefly pressing the M or S button or by removing the test strip from the meter. If these error messages occur frequently, contact your customer support and service centre. If your meter has been dropped, it can also lead to error messages. In this case also contact your customer support and service centre.
Symbols, problems and error messages You did not insert the test strip correctly or completely. Hold the test strip so the arrows printed on it and the orange square face upwards. Without bending it, gently push the test strip into the test strip guide in the direction of the arrows until you feel it lock into place. You removed the test strip from the meter in order to apply blood and did not re-insert it within 20 seconds. Dispose of the test strip, even if blood has not been applied yet.
Symbols, problems and error messages The code chip cannot be read. Remove the code chip and re-insert it into the meter. If the error message appears again, you cannot use the code chip and test strips belonging to it. A code chip from another blood glucose system has been inserted into the meter. The code chip does not belong to the Accu‑Chek Active test strips. Remove the code chip and insert the code chip that belongs to the Accu‑Chek Active test strips you are currently using.
Symbols, problems and error messages You have inserted a used test strip into the meter. Start again from the beginning with an unused test strip. The measuring window is dirty. Clean the measuring window (see Chapter 8). You did not insert the test strip correctly or completely. Hold the test strip so that the arrows printed on it and the orange square face upwards.
Symbols, problems and error messages You removed the code chip while testing was in progress. Re-insert the code chip into the meter and repeat the test with a new test strip. The test strip was bent or moved while testing was in progress. Repeat the test with a new test strip. You did not insert the test strip correctly or completely. Hold the test strip so that the arrows printed on it and the orange square face upwards.
Symbols, problems and error messages 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. You applied too little blood or control solution to the test strip. Repeat the test with a new test strip and a larger amount of blood or control solution.
Symbols, problems and error messages 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 +10 and +40 °C and wait for the meter to adapt to that temperature.
Technical data 13 Technical data Meter type Accu‑Chek Active (Model GC) Catalogue no./Serial no. See type plate on the back of the meter Test principle 116 Determination of glucose in fresh capillary blood by reflectance photometry. If using other sample material, please refer to the package insert that came with the Accu‑Chek Active test strips. Blood glucose concentrations may be tested in whole blood or plasma.
Technical data Measuring range 10–600 mg/dL (0.6–33.3 mmol/L) Sample size 1–2 µL (1 µL (microlitre) = 1 thousandth of a millilitre) Measuring time approx. 5 seconds if the test strip is in the meter when blood is applied (depends on concentration) approx. 10 seconds if the test strip is outside the meter when blood is applied (depends on concentration) Power supply 1 battery (type CR 2032) Battery life approx. 1000 tests or approx.
Technical data Temperature during testing during storage without battery with battery +10 to +40 °C -25 to +70 °C -10 to +50 °C Atmospheric humidity during testing during storage up to 85 % relative humidity up to 93 % relative humidity Altitude sea level to 4000 m Dimensions 104.5 × 51.5 × 22 mm Weight without battery with battery approx. 55 g approx.
Technical data Display 96-segment liquid crystal display (LCD) Interface infrared port Safety class III LED/IRED Class 1 Electromagnetic compatibility This meter meets the electromagnetic immunity requirements as per 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. Its electromagnetic emission is thus low.
Technical data Performance analysis 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 is calibrated with venous blood containing various glucose concentrations. The reference values for this were obtained using the hexokinase method.
Disposing of your meter 14 Disposing of your meter During blood glucose testing the meter itself 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. i Dispose of used batteries in an environmentally friendly way at a collection depot or through your dealer.
System components 15 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 performance checks using the Accu‑Chek Active meter and the respective test strips.
Patents 16 Patents US 5,366,609; US 5,424,035; US 5,463,467; US 5,889,585; US 6,055,060; US 6,906,802 123
Customer support and service 17 Customer support and service 17.1 Information service and troubleshooting For questions on how to operate your Accu‑Chek Active meter, or regarding implausible results, or if you suspect the meter to be defective, please contact your customer support and service centre. Do not attempt to repair or modify the meter yourself. Our staff will help you solve any problems you might be experiencing with the meter or test strips from Roche Diagnostics.
Customer support and service PT. Roche Indonesia. Diagnostics Division. Gedung Artha Graha, lt.21. SCBD - Lot 25. Jl.Jendral Sudirman Kav. 52-53. Jakarta 12190, Indonesia Hotline: 0 800 1 222 999 Promotional Office Levante Nabih Nabulsi Drugstores Prince Shaker Ben Zeid Street Shmeisani P.O.Box 1066 11118 AMMAN Jordan http://www.accu-chekarabia.com Roche Diagnostics (M) Sdn Bhd 2A, Jalan 13/1 46200 Petaling Jaya Selangor Darul Ehsan Malaysia Toll-Free Line: 1-800-88-1313 Roche Pakistan Ltd.
Customer support and service Roche Diagnostics Asia Pacific Pte. Ltd 298, Tiong Bahru Road #16-01/06 Central Plaza Singapore 168730, Singapore Roche Products (Pty) Ltd. South Africa Diagnostics Division 9, Will Scarlet Road / Ferndale P.O.
Alphabetical index 18 Alphabetical index A Alternative sites 40 Apple (symbol) 40, 103 Apple core (symbol) 40, 103 Asterisk (symbol) 40, 102 Atmospheric humidity 98, 118 ave (symbol) 60, 102 Averages 58 B Battery changing 87 life 87, 117 removing protective film 18 symbol 45, 87, 101 type 13, 87, 117 Battery compartment 13, 88 Blood applying to test strip with test strip inside the meter 34 with test strip outside the meter 36 too little applied 114 volume 14, 117 Bottle (symbol) 40, 76, 104 C Causes of e
Alphabetical index Code number 29, 32 Coding 28 Concentration table 71, 77 Control solution 70 stability 81 Control window, test strips 43 Customer support and service 124 Disposal battery 90, 121 meter 121 test strips 39, 78 Downloading, results 64 causes of error 69 Drop (symbol) 33, 103 D Data downloads 15, 64 Date setting 26 day (symbol) 60, 102 Disinfection 95 Display 12 example 6 symbols in the ~ 101 Display check 20, 32 E E and number (display) 110 EEE (display) 114 Electromagnetic compatibility
Alphabetical index F Flagging, result 40 H Healthcare professionals 3, 91 Hi (display) 45, 50, 106 Hourglass (symbol) 35, 102 I Infection risk 91, 92 Infrared port 12, 64 Intended use 3 L Light conditions 98 Lo (display) 45, 50, 105 M M button 12 Measurement conditions 96 Measuring range 50, 117 Measuring time 35, 38, 117 Measuring window 12 cleaning 83, 85 Memory 53 memory (symbol) 54, 101, 105 Memory, results 53 Meter checking 70 cleaning 83 disinfecting 95 disposal of 121 overview 12 storage 96 turning
Alphabetical index mg/dL (symbol) 102 mmol/L (symbol) 102 O Overview meter 12 symbols 101 P Patents 123 PC (display) 66, 106 Performance analysis 120 Performance check causes of error 79 flagging 76 procedure 70 Problems 107 130 R Result averages 58 downloading 64 flagging 40 retrieving from memory 54 S S button 12 Settings (date and time) 21 changing, overview 22 date 26 factory defaults 21 order 21 time 25 time and date format 24 year 26
Alphabetical index set-up (symbol) 22, 102 Sources of electromagnetic interference 99 Sources of interference electromagnetic ~ 99 light 98 Storage conditions 96 Sun (symbol) 98, 102 Symbols 101 during testing 45 System components 122 T Technical data 116 Temperature 96, 118 Testing causes of error 51 healthcare professionals 93 procedure 30 Test principle 116 Test strip guide 12 cleaning 83, 84 Test strips disposal of 39, 78 expiry date 52, 81 symbol 33, 36, 102, 103 Thermometer (symbol) 45, 103 Time and
Alphabetical index Turning on changing settings 22 downloading results 66 retrieving results 54 testing 31 Type plate 13, 17 132 U Unit of measurement for results (mg/dL, mmol/L) 17, 102 Y Year setting 26
