ONR 3077 – 4all 4354 (2013) Frau Ritzerfeld Prüfmittelnummer n/a V1/1 – man_cover_06658768001_01_EN_ Format 127 x 154 mm – Black R2/1 – man_cover_06658768001_01_EN_ Format 127 x 154 mm – Black R2/2 – man_cover_06658768001_01_EN_ Format 127 x 154 mm – PMS 287 CVC User’s Manual C 06658768001(01) – 2013-03 M_Version01_Rev2 Blood Glucose Meter ©2013 Roche Diagnostics ACCU‑CHEK is a trademark of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany M www.accu‑chek.com 4-1 25.
This User’s Manual features three types of warning: W This symbol indicates a possible risk of injury or of damage to your own health or the health of others. H This symbol draws attention to actions that could result in damage to the meter. Explanation of symbols Various symbols are featured on the packaging and type plate of the meter. Their meanings are as follows: Symbol B W i This symbol draws your attention to important information.
Contents Contents Intended use �������������������������������������������������������������������������������������������������������������������������������� 2 About this User’s Manual �������������������������������������������������������������������������������������������������������������� 3 1 Getting to know the blood glucose monitoring system ���������������������������������������������������������� 4 2 Steps before testing �������������������������������������������������������������������������
Intended use 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 different sample material. The blood glucose monitoring system comprises the meter and test strips and is suitable for self-testing and for professional use.
About this User’s Manual 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.
1 Getting to know the blood glucose monitoring system Getting to know the blood glucose monitoring system The Accu-Chek Active blood glucose meter and its components 6 7 1 8 2 9 5 4 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 10 3 6.
Getting to know the blood glucose monitoring system 1 Buttons of the blood glucose meter Overview of the M and S button functions: 11 14 12 13 15 M button S button Press the M button to Press the S button to turn the meter on and call up saved values turn the meter on and call up settings, e.g.
1 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 insufficient, and more blood can be applied.
Steps before testing 2 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 different units of measurement (mg/dL or mmol/L). Two different versions of the same meter are therefore available.
2 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. 1 2 mg/dL meter With the meter turned off, press the M and S buttons at the same time for approximately 2 seconds until the meter is switched on. mmol/L meter Compare the elements displayed on your meter with the display shown here.
Steps before testing 2 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. W • 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.
3 Changing settings 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 1 Press the S button for longer than 2 seconds. Changing settings 2 The display above appears on the display.
Changing settings Go to the next setting 3 Turning the meter off Order of the settings Turning off Time format Time (hour) Time (minute) Year Date (month) Date (day) Press the M and S buttons briefly at the same time. When the final display appears on the display, the modified settings are also saved. Beep (on, off) i 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.
3 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 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 format, the time and date are changed accordingly. 24-hour format The time format flashes on the display. Setting the time format Press the M button briefly to switch from one format to the other.
Changing settings 3 Setting the time and date 24-hour format Setting the hours 12-hour format The hours flash on the display. 24-hour format 12-hour format Press the M button to set the hours. Setting the minutes. 12-hour format The minutes flash on the display. Year The year flashes on the display. 24-hour format Press the S button. Next come the minutes. 24-hour format 12-hour format Press the M button to set the minutes. Setting the year Press the M button to set the year.
3 Changing settings 24-hour format Setting the month 12-hour format The month flashes on the display. 24-hour format 12-hour format Press the M button to set the month. Setting the day 12-hour format The day flashes on the display. 24-hour format Press the S button. Next comes the day. 24-hour format 12-hour format Press the M button to set the day. Press the S button. Next comes the beep. 14 man_06658768001_01_EN.indb 14 04.04.
Changing settings 3 Setting the beep Beep is on The beep symbol appears together with (on) on the display. Turning the beep on or off Press the M button briefly to turn the beep on or off. Beep is off The beep symbol appears (off) on the together with display. Press the S button. Next comes the final display. Final display on the display 24-hour format 12-hour format At the end of making settings, the meter displays the current settings.
4 Testing blood glucose Testing blood glucose Using the Accu-Chek Active meter, you can test blood glucose in two different 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).
Testing blood glucose 4 Testing blood glucose Turning the meter on 1 2 3 mg/dL meter 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 meter turns on and first performs a default display check (approx.
4 Testing blood glucose 4 5 i 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. Check that this code number is the same as the code number on the label of the test strip container. Following the code number, the test strip symbol and the flashing blood drop symbol appear on the display. You now hear a beep.
4 Testing blood glucose Applying blood With test strip in the meter 1 2 3 mg/dL meter A B mmol/L meter Lance the side of a fingertip with your lancing device. Figure A shows the recommended sites for obtaining blood. Encourage a blood drop to form by gently massaging the finger towards the fingertip (see B ). 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.
4 Testing blood glucose Applying blood With test strip outside the meter 1 2 3 A B Lance the side of a fingertip with your lancing device. Figure A shows the recommended sites for obtaining blood. Encourage a blood drop to form by gently massaging the finger towards the fingertip (see B ). 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.
Testing blood glucose 4 Turning the meter off 4 5 Turn off mg/dL meter mmol/L meter 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. 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.
4 Testing blood glucose Notes on blood glucose testing W Incorrect results can cause the wrong therapy recommendation to be made and so produce serious adverse health effects. 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.
Testing blood glucose 4 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.
4 Testing blood glucose 1 2 mg/dL meter No marker Control Before meal 1 Test reminder Other mmol/L meter In the example above, the Before meal marker ( symbol) was selected. After meal After choosing the desired marker, you can turn the meter off. As long as the test result is being displayed on the display, you can mark the test result. The test result is saved together with the marker. Press the S button or M button repeatedly until the desired marker is displayed.
Testing blood glucose 4 Setting a test reminder 1 2 mg/dL meter i 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. 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 ( symbol) is displayed.
4 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. 1 2 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.
Testing blood glucose 4 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).
4 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. W • 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.
Testing blood glucose 4 Did you bend the test strip while sliding it into the meter? no Did you apply the blood drop immediately after it formed? 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 e symbol on the test strip symbol on your meter’s display)? container label and also the no Are the test strip guide and measurement window clean? yes Did you perform the test within the correct temperature range (+8 to +4
5 Using the meter as a diary 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 all the memory locations are occupied, 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.
Using the meter as a diary 5 Order of the saved test results In increasing order up to the oldest test result (memory location 500) to the averages In decreasing order down to the newest test result (memory location 1) mg/dL meter mmol/L meter 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.
5 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.
5 Using the meter as a diary Order of the averages Before meal (7, 14, 30, 90 = number of days taken into account) mg/dL meter All results ➞ ➞ ➞ ➞ Results marked with ➞ ➞ ➞ ➞ ➞ Results marked with ➞ ➞ ➞ ➞ (Before meal) ➞ mmol/L meter “Before meal” averages are marked with . After meal (After meal) ➞ ➞ ➞ mg/dL meter ➞ 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.
5 Using the meter as a diary Back To go back to the saved test results: Press the M button until a saved test result appears on the display. Turn off To turn the meter off: Press the M button and S button at the same time. No average If there are no test results saved for the selected average, three dashes are displayed. 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.
Analysing test results on the PC 6 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 offers a variety of special diabetes management hardware and software products which enhance the integrated diary functions of your meter.
6 Analysing test results on the PC 2 3 If the meter is off, 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.
Analysing test results on the PC 4 5 6 i 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 off, unplug the USB connector from the meter once the data transfer is complete. For approximately 3 seconds, is displayed. The meter turns itself off.
7 Checking your meter Checking your meter You can check whether the meter provides correct test results. To perform this control test, a 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 about a blood glucose result.
Checking your meter 7 Carrying out a control test 1 2 3 mg/dL meter mmol/L meter Read the package insert which comes with the control solutions. Take a test strip from the test strip container. Close the 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. The test strip must lie flat on the measurement window cover.
7 Checking your meter 4 5 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 dropper with a clean, dry paper towel. Hold the bottle downwards at an angle. Squeeze it gently until a small drop which is free of any air bubbles is suspended from the tip of the dropper.
Checking your meter 7 8 7 9 These figures are only examples mmol/L meter Accu-Chek® Active Control Level mg/dL meter mg/dL mmol/L 1 40-70 2.2-3.9 2 135-182 7.5-10.1 Control solution Unit of used measurement While the result of the control test is being displayed: After marking the result as a control test: Then remove the test strip from the meter. Press the M button briefly once.
7 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 different from those given, make the respective corrections when you perform the next test.
Checking your meter 7 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.
8 Cleaning the meter Cleaning the meter If the meter is dirty, it may be necessary to clean it. W Healthcare professionals using the meter to test several patients’ blood glucose must also read the instructions on disinfection (see page 49). H • 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 meter Cleaning the measurement window 1 8 2 CLICK Carefully dab the measurement window and its surrounding area using a lightly moistened cloth or cotton swab. H • Make sure that no water enters the meter. • Avoid scratching the measurement window. 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.
9 Changing the battery 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 affect 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.
Changing the battery 4 5 9 W CLICK Never throw batteries into a fire. They may explode. j Dispose of used batteries in an environmentally friendly way at a collection depot or through your dealer. Place the battery compartment cover back on again. The two prongs on the lower edge must engage with the slots in the battery compartment. Press the battery compartment cover closed. It will CLICK into place audibly. 47 man_06658768001_01_EN.indb 47 04.04.
10 Testing blood glucose in more than one patient Testing blood glucose in more than one patient Information for healthcare professionals Only staff working in doctors’ practices, hospitals and diabetes training centres, and nursing staff for inpatients and outpatients 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 10 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.
11 Test and storage conditions 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 W • 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.
Test and storage conditions 11 Light conditions W 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. Avoid sudden changes in light conditions while testing. The flash of a camera, for example, can lead to incorrect test results. If the meter is exposed to too much light, the meter does not allow any tests to be performed.
12 Symbols, problems and error messages 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, problems and error messages Symbol 12 Meaning 4 When an average is displayed (memory): the symbol is preceded by the number of days taken into account. 5 Together with error message E-5: The meter is exposed to too much light. 6 Flashing – A test is in progress or an average is being calculated. 7 The beep is turned on. 8 or 9 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.
12 Symbols, problems and error messages Symbols appearing in the numeric field mmol/L meter mg/dL 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.
Symbols, problems and error messages Symbol 12 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).
12 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 there. • 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.
Symbols, problems and error messages 12 Error messages When an error occurs, an error message appears on the display and two beeps sound. Turn the meter off. 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 off. 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.
12 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.
Disposing of your meter 13 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.
14 Technical data and system components Technical data and system components Technical data Meter type Accu-Chek Active (Model GU) Catalogue no./Serial See type plate on the back of the meter no. Test principle Determination of glucose in fresh capillary blood by reflectance photometry. If 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.
Technical data and system components Altitude sea level to 4000 m Dimensions 97.8 × 46.8 × 19.1 mm Weight without battery: approx. 46 g 14 with battery: approx. 50 g Display 96-segment liquid crystal display (LCD) Interface USB (Micro B) Safety class III Electromagnetic compatibility This blood glucose meter meets the electromagnetic immunity requirements as per EN 61326-2-6 and EN ISO 15197 Annex A.
14 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.
Customer Support and Service Centre 15 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.
15 Customer Support and Service Centre 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 (office 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.
Index Index A display 4 display check 8, 17 drop (symbol) 18, 53 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 E B I battery (symbol) 27, 46, 52 beep 53 bell (symbol) 23, 53 bottle (symbol) 23, 53 C 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
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