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This instrument complies with DIN EN 61010-1 (“Safety requirements for electrical equipment for measurement, control and laboratory use; General requirements”) and was in a perfect safety condition when it left the factory. Installation, use and maintenance of the Accutrend Plus instrument is the full responsibility of the user.
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The packaging material, the identification plate of the instrument and the manual may contain the following symbols or abbreviations which are listed below with their meaning: Consult instructions for use. Caution (refer to accompanying documents)! Refer to safety-related notes in the manual accompanying this instrument.
The Accutrend Plus instrument Thank you for your purchase of the Accutrend Plus instrument! The Accutrend Plus instrument is used for quantitative measurement of two blood parameters: glucose and cholesterol. The reflectance photometric measurement is performed using test strips specific for each of these blood parameters.
Contents Contents The Accutrend Plus instrument Introduction The Accutrend Plus instrument ................................11 Test principle ......................................12 Checking the contents ...................................13 Safety information ....................................14 Operating conditions ....................................15 Integrated control functions ..................................16 About this manual Page layout ........................................ 17 The Accutrend Plus instrument Overview of instrument elements ................................20...
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Contents Instrument settings Brief overview of the instrument settings ............................32 General procedure for setting up the instrument (set mode) .......................33 Setting the date format ...................................37 Setting the date ......................................38 Setting the time format ...................................41 Setting the time ......................................42 Setting the beeper ....................................43 Performing a measurement Brief overview of the steps to be carried out .............................45 Important notes ......................................
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Contents Quality control recommendation Preparing to perform a control test ..............................82 Performing a control test ..................................83 Applying the control solution ................................88 Starting the measurement ..................................89 Display of results ......................................91 Memory Displaying stored measured values ..............................92 Cleaning Cleaning the outer instrument components .............................98 Cleaning the inner instrument components ............................98 Cleaning the optical measuring system............................100 Error messages...
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Contents Product specifications Operating conditions and technical data ............................112 Sample material......................................113 Storage and transport conditions ..............................113 Disposal of instrument, strips, lancets and batteries ........................113 Service information ....................................114 Alphabetical index...
Introduction The Accutrend Plus instrument The Accutrend Plus instrument is used for quantitative measurement of 2 blood parameters: glucose and cholesterol. The instrument is suitable for professional use as well as for self-testing. If you have any questions which are not answered by this manual, call the ACCU-CHEK Customer Care Service...
Introduction Test principle By means of a code strip, the instrument reads the lot-specific characteristics of the test strips currently in use. This information is stored and must therefore only be read once per test strip container. To run a test, an unused test strip is taken from the container and inserted into the instrument.
Introduction Checking the contents • Accutrend Plus meter • User’s Manual • Four 1.5 V AAA alkaline batteries • Quick Reference Guide • Carrying Case • Warranty Card...
Safety information Protection against infection There is a potential risk of infection. Medical staff and other persons using the Accutrend Plus instrument to perform measurements for more than one patient must be aware that any object coming into contact with human blood is a potential source of infection.
Introduction Operating conditions To ensure proper function of your Accutrend Plus instrument, observe the following guidelines: • Operate the instrument only within the acceptable temperature range. This range is test-dependent: • For cholesterol: 18-30ºC (64-86ºF) • For glucose: 18-32ºC (64-90ºF) •...
Introduction Integrated control functions The Accutrend Plus instrument has numerous integrated or available control functions, including the following: • An automatic check of the electronic components and functions when the instrument is powered on. • An automatic check of the ambient temperature before and during the measurement.
About this manual About this manual Page layout The page layout of this manual enables you to easily locate the most important information. Where illustrations are used, they always appear on the left side with the accompanying explanation on the right. All instructions which require you to perform an action, in addition to very important information, appear on a colored background.
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About this manual Example of an instruction: The left column contains an illustration of the The right column states what you should do at this instrument. point, for example: Press the On/Off button , to power the instrument on for measurement.
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About this manual Example of a display screen: This column contains the illustration of a display This column contains information relating to the screen. display screen, for example: Every time the instrument is powered on, you can check the display. The instrument temporarily shows all symbols that may appear in the display.
The Accutrend Plus instrument The Accutrend Plus instrument Overview of instrument elements...
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The Accutrend Plus instrument Display Test strip guide Shows measurement results, information, Insert the test strip here. symbols and all stored measured results. Set button M button (memory) By pressing this button, you access the various By pressing this button, you can retrieve all...
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The Accutrend Plus instrument Battery compartment lid Provides access to the battery compartment (4 AAA 1.5 alkaline batteries). Measurement chamber cover (with test strip guide) You can remove this cover to clean the test strip guide and optics cover.
The Accutrend Plus instrument Display and symbols Every time the instrument is powered on, you should check the display. The instrument temporarily shows all symbols that may appear in the display. Regularly check that all display elements are functioning correctly to prevent misinterpretations due to a defective display.
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The Accutrend Plus instrument Set mode Code display Memory mode Test mode (measurement) Test parameter: glucose Test parameter: cholesterol Test strip flashes: insert Test strip and blood drop: apply blood Measurement time in seconds Display of the code number In the morning...
The Accutrend Plus instrument Power To save power, the instrument powers itself off after 2 minutes unless a button is pressed or a new test strip is inserted. When the instrument turns itself off, all test results obtained so far remain in the memory. With a set of fresh batteries, you will normally be able to perform approximately 1,000 measurements.
Operating the instrument Operating the instrument Before using the instrument for the first time, perform the following steps: Insert batteries. Set date, time and beeper. Insert code strip (can also be done directly before performing the measurement).
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Operating the instrument Ensure the instrument is switched off and turn it over. Open the battery compartment by slightly pressing the tab towards the center of the instrument. Lift the lid upwards to remove it from the instrument. Insert four batteries into the compartment according to the illustrations.
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Operating the instrument Replace and close the battery compartment lid. Power the instrument on to test the function of the new batteries. Check that the display functions correctly by comparing it to the diagram on the left to prevent misinterpretations due to defective display elements.
Operating the instrument Instrument settings Brief overview of the instrument settings The following table provides an overview of the available settings. Setting Options Default setting * Date format Day.Month.Year (31.12.00) Month-Day-Year Month-Day-Year (12-31-00) Date 12-31-00 Time format 24-hour time format (24h) 12-hour time format (12h), with am/pm Time 12:01 a.m.
Instrument settings General procedure for setting up the instrument (set mode) You make all settings using the Set and M buttons as described below. The instrument must be powered off before you can activate the set mode. Press the Set button (on the left side of the instrument) to power the instrument on in set mode.
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Instrument settings The date and time as well as the set symbol now appear on the display. To actually make or change settings, press the Set button again, located on the left side of the instrument To leave the set mode (this is only possible if a date and time setting is made), press the On/Off button Note: If the meter display reads dEL...
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Instrument settings If the displayed setting is correct (e.g., the date is correct and you want to change the time only), you can continue directly to the next setting by pressing the Set button or: Press the M button to change the currently flashing setting.
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Instrument settings Press the Set button again to save the current setting and go to the next setting. You can only move forward through the settings. Moving backwards is not possible. Corrections can only be made by repeating the settings. The setting procedure can be terminated at any time by pressing the On/Off button The settings made up to that point are saved.
Instrument settings Setting the date format In the first step, you set the date format (the entire date flashes). In the following illustrations, flashing display elements are represented by a “beam circle. ” The following date formats are available: 31.12.00 Day.Month.Year •...
Instrument settings Setting the date With the next three settings, you first enter the year, then the month and finally the day. Press the M button to change the currently flashing figure and to set the current year. Press the Set button to save the displayed year. The display then automatically switches to the mode for setting the current month.
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Instrument settings The default month flashes. Press the M button until the desired month is displayed. Press the Set button to save the setting. The display then automatically switches to the mode for setting the current day.
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Instrument settings The default day flashes. Press the M button until the desired day is displayed. Press the Set button to save the selected setting and to continue setting the time format. The display then automatically switches to the mode for setting the time format.
Instrument settings Setting the time format Now select the time format to be used: either the international format (24h display) or the Anglo-American format (12h display with am or pm = default setting). Press the M button to switch between the 24h and 12h displays.
Instrument settings Setting the time First enter the current hour and then the minutes. Press the M button to change the currently flashing figure. The next time the Set button is pressed, the minutes can be set (again with the M button).
Instrument settings Setting the beeper After setting the time, you can set the beeper by choosing On or OFF. We recommend that you always leave the beeper enabled. If the beeper is enabled, you will hear a beep in the following situations: When the instrument detects that the test strip is inserted.
Performing a measurement Performing a measurement What you need: Your Accutrend Plus instrument • Test strips for the desired measurements with the related code strip: • – Accutrend Glucose – Accutrend Cholesterol Lancing device (For healthcare professionals, a device suitable for use in a professional multipatient setting •...
Performing a measurement Important notes Always … operate the instrument at the acceptable test-specific temperatures (see also the test strip inserts): • – For cholesterol: 18–30°C (64-86ºF) – For glucose: 18–32°C (64-90ºF) place the instrument on a level surface or hold it steady in your hand •...
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Performing a measurement Never … touch or remove the test strip during actual measurement (this is possible before starting the measurement • when blood is applied outside the instrument) delay starting the measurement after blood application • subject the instrument to sudden movements during a measurement •...
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Performing a measurement Test strips Code strips...
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Performing a measurement A Test strip (top side, CHOL in the example) Code strip (top side, CHOL in the example) Contains the application area. Supplied with each test strip container. B Application area Code strip (bottom side) Apply the sample here. The imprinted barcode contains lot-specific information which is read and stored in the instru- C Test strip (bottom side)
Performing a measurement Code strips The code strip provides the instrument with important information on the specific properties of the respective test strip. The code strip is required at least when a new test strip container is opened and before the strips are used. The properties of these test strips are then stored in the instrument.
Performing a measurement Switching on the instrument Place the instrument on a level surface or hold it in your hand. Power on the instrument by pressing the On/Off button Note: To power the instrument off again, press and hold the On/Off button until the meter shuts off...
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Performing a measurement Check that the whole display is functioning correctly to prevent misinterpretations due to defective display elements. Also always check the battery condition after the display test. When the battery symbol is shown with a measurement screen (except during the display test), you will only be able to perform a few more measurements.
Performing a measurement Inserting the code strip Hold the code strip with thumb and index finger in the white area located at the end of the strip. Do not touch the printed area on either side. Insert the code strip smoothly into the test strip guide up to the stop in the direction of the printed arrows.
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Performing a measurement The three-digit code number (which is also printed on the reverse side of the code strip and on the test strip container) is shown in the display. If any problems occur during coding, the meter displays an error message (see Error Messages chapter of this manual).
Performing a measurement Switching the code display You can switch between the display of the stored code numbers for information purposes. The code number last stored or used is displayed after powering on the instrument. Press the Set button to switch to the code number for the other parameter.
Performing a measurement Sample material Fresh capillary blood is used as sample material. You need a free hanging blood drop for measurement. For more information on sample material, refer to the test strip package insert. Note that all handling of blood samples represents a risk of infection. Therefore, take the correspond- ing safety measures, such as wearing disposable gloves while working.
Protection against infections: There is a potential risk of infection. Medical staff and other people using the Accutrend Plus instrument to perform measurements for more than one patient must be aware that any object coming into contact with human blood is a potential source of infection.
Performing a measurement Preparing to perform a measurement Get the test strip container for the required measurement. Check the expiration date of the test strip. Always use test strips before their expiration date has passed. Make sure the code strip belonging to these test strips is at hand (unless the instrument has already been coded with this code strip).
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Performing a measurement Prepare the lancing device by inserting a new lancet. Self-testers: Do not lance yourself before being instructed to do so in the course of this description. In the professional, multi-patient sector you should use a suitable single-use lancing device to prevent cross contamination.
Performing a measurement Performing a measurement After it is switched on and coded, the instrument expects you to insert the test strip. From the barcode on the reverse side, the instrument detects which test parameter is to be measured and which code is needed for the test strip.
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Performing a measurement Now take the test strip from the test strip container. Close the container immediately after removing strip to protect the desiccant and strips, otherwise, the test strips may become unusable before their expiration date. Liquids must not enter the test strip container.
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Performing a measurement Hold the test strip with thumb and index finger so that the sample application area is facing upwards. Insert the test strip into the test strip guide up to the stop. When the test strip reaches the correct position, you will hear two beeps (short –...
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Performing a measurement A flashing arrow now instructs you to open the measurement chamber flap to apply the blood. Explanations on flagging this measurement (events, ev. 0 display or control flag) are provided later in this chapter. Open the measurement chamber flap. The flap firmly locks into place when it reaches a vertical position.
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Performing a measurement The flashing drop symbol (above the strip symbol) now instructs you to apply the blood. Blood can be applied either in the instrument or outside the instrument.
Performing a measurement Recommendations for the collection and measurement of capillary blood To obtain a suitable blood drop: Wash your hands with warm water. • Ensure hands are warm and dry before lancing • If needed, massage your fingertip. After lancing yourself, try to obtain a sufficiently large free hanging drop •...
Performing a measurement Blood collection Lance the outer side of the fingertip using the lancing device to obtain a large hanging drop of blood.
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Performing a measurement Blood application in the instrument: Apply a large hanging drop of blood directly from the finger to the yellow sample application area of the test strip. Do not touch the application area with the finger. The drop of blood must be applied to the test strip immediately after lancing the fingertip.
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Performing a measurement Alternative blood application outside the device: 10 Withdraw the test strip after opening the flap (leave it open). 11 Apply the free hanging drop of blood directly from the finger to the yellow sample application area of the test strip. Refer to the insert of the respective test strip.
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Performing a measurement Checking the applied blood: The application area must be completely covered with blood (example A), otherwise incorrect values may be obtained. If too little blood is applied (example B), do not try to spread it or apply a second drop as this may lead to a false measurement.
Performing a measurement Starting the measurement 13 Close the measurement chamber flap. This starts the actual measurement.
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Performing a measurement The time needed to evaluate the sample varies depending on the test parameter. This time is shown in the display and counted down to “0. ” The measurement times of the individual test parameters are: For glucose: 12 seconds •...
Performing a measurement Display of results When measurement is finished, the result is displayed. If you are measuring glucose, perform the plausibility check described on the next page. Measurement results which fall outside the meter measurement range are displayed as Hi (above the measurement range) or Lo (below the measurement range).
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Performing a measurement Plausibility check after glucose measurement: Remove the test strip and turn it with the • bottom side upwards. Compare the reaction area on the bottom side of • the strip with the color field scale on the label of the test strip container.
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Performing a measurement If the displayed result (particularly when blood glucose is measured) does not match your state of health or seems to be unusually high or low, check the meter function using a new test strip (see the Control Check with Control Solution chapter of this manual).
Performing a measurement Flagging measurements You can add additional information to measurements, for example, to characterize a particular value with regard to special circumstances (e.g., meals or exercise). In addition, you can flag measurements carried out with control liquids as controls. You can flag a measured value at different points in time: At the start of the measurement after inserting the test strip.
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Performing a measurement Flagging the measurement as a control: You flag measurements as controls when they have been performed using a control solution (as described in the following chapter). 14 Press the M button (after inserting the test strip or when the result is displayed) to flag the measurement as a control (bottle symbol).
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Performing a measurement Assigning additional information to a measurement: Optionally, you can assign one of nine different events to a measurement. The event “0” represents “no flagging. ” If used, you must define the events and their respective event numbers yourself. Make sure that your assignments are unique and reproducible.
Quality control recommendation Quality control recommendation To ensure that the instrument is functioning properly, you should regularly use two levels of control solutions for a function check. For each test parameter, separate control solutions are available. Make a habit of carrying out a function check in the following situations: If you leave the cap off the container of test strips.
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Quality control recommendation What you need: Your Accutrend Plus instrument • Test strips for the desired measurements with the related code strip: • – Accutrend Glucose – Accutrend Cholesterol Control solutions for the respective test parameter: • – Accutrend Glucose Control Low Level –...
Quality control recommendation Preparing to perform a control test Get the test strip container for the required measurement (e.g., cholesterol). Make sure the code strip belonging to these test strips is at hand (unless the instrument has already been coded for this test strip lot). Get the proper control solutions for the test strips.
Quality control recommendation Performing a control test Place the instrument on a level surface or hold it in your hand. If required, switch on the instrument by pressing the On/Off button...
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Quality control recommendation After switching on the instrument, check the following displays: Check that the whole display is functioning correctly to prevent misinterpretations due to defective display elements. Are date and time correct? If the measured val- ues are to be stored with time information, enter the correct settings (see the Setting the date section of this manual).
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Quality control recommendation Now take the test strip from the test strip container. Close the container immediately after removing strip to protect the desiccant and strips, otherwise the test strips may become unusable before their expiration date. Hold the test strip with thumb and index finger so that the printed measurement parameter is facing upwards.
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Quality control recommendation Press the M button to flag the measurement as a control (bottle symbol is displayed).
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Quality control recommendation Open the measurement chamber flap. The flap firmly locks into place when it reaches a vertical position.
Quality control recommendation Applying the control solution 10 Apply a large free hanging drop of either the glucose or cholesterol low level control solution directly from the bottle to the test strip. Ensure that neither the bottle nor your fingers touch the application area.
Quality control recommendation Starting the measurement 11 Close the measurement chamber flap. This starts the actual measurement.
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Quality control recommendation The measurement time varies depending on the test parameter. This time is shown in the display and counted down to “0. ” The measurement times of the individual test parameters are: For glucose: 12 seconds • For cholesterol: 180 seconds •...
Quality control recommendation Display of results When measurement is finished, the result is displayed. Now check whether the displayed result falls within the acceptable range. Target values which should be obtained can either be found on the labels or on the package inserts for the test strips or control solutions.
Memory Memory The Accutrend Plus instrument has two memory areas, each of which can be used to store up to 100 measured values together with date, time and event flags. If you have not set any date and time (see the Setting the date section of this manual), all measured values will be stored without date and time information.
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Memory After the usual display test has been performed when switching on the instrument, the last stored measured value is displayed. The mem symbol indicates that the instrument is in memory mode. The date and time on the display match the time at which the measurement was performed, and not the current time.
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Memory Press the Set button to switch between the memory areas of the two test parameters. Each time you press the Set button, the last stored value of each memory area, if any, is displayed. If the area contains no stored values, two dashes are displayed.
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Memory To navigate within one memory area, use the M button. Press the M button to show the next oldest measured value within one memory area. When you press the button, the place of the measured value within the memory is displayed (here: 02); the actual value is not shown until you release the button.
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Memory Special cases: If the entire memory is empty, three dashes (– – –) will appear in the display. If the entire memory area of a test parameter is empty, two dashes (– –) will appear in the display. If a single measured value is stored incorrectly, one dash (–) will appear in the display.
Cleaning Cleaning A clean optical measuring system is a basic prerequisite for determining precise measured values. Therefore, clean the instrument regularly and immediately after it becomes dirty. Always power off the instrument before cleaning it! Use only the following items for cleaning: Ordinary lint-free cotton balls •...
Cleaning Cleaning the outer instrument components Ensure the instrument is powered off. • Wipe the outside of the instrument with a lightly moistened, lint-free cotton cloth. In the professional sector, • the outside of the instrument can be cleaned with “Bacillol plus. ” Cleaning the inner instrument components Open the measurement chamber flap.
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Cleaning If needed, you can rinse the strip guide (separately from the instrument) under warm running water. Dry the strip guide with a clean cloth.
Cleaning Cleaning the optical measuring system Clean the easily accessible areas of the optical measuring system under the strip guide with a lint-free pad or a moistened cotton ball. Make sure that no liquid enters the instrument. Do not insert any objects into the instrument.
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Cleaning Do not put the strip guide back in the instrument until it is completely dry. Press the front end of the strip guide slightly downwards until you feel it click into place. Close the measurement chamber flap. The instrument is now ready for operation again. Perform a function check (see description starting on page 78).
Error messages Error messages In certain circumstances error messages may appear on your display. Generally, you should first try the following solutions. If the problem persists, please contact your local customer support and service center.
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Error messages Display Error meaning and description Error: Unknown barcode The barcode of test strips or code strips could not be read. Solution All strips: Remove the strip and check the barcode for dirt. • Test strips: Repeat the procedure with a new strip. •...
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Error messages Display Error meaning and description Error: Strip code does not match stored code The test strip belongs to a different test strip lot than the container which was last coded for this parameter. Solution Remove the strip and repeat using a test strip matching the last code for the test being attempted. •...
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Error messages Display Error meaning and description Error: Test strip is unusable The test strip has already been used or is dirty. Solution Remove and discard the strip. Repeat the measurement using a new test strip. •...
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Error messages Display Error meaning and description Error: Temperature The instrument or ambient temperature does not fall within the acceptable range for the selected test. Solution Move the instrument to an environment which has an appropriate temperature and repeat the •...
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Error messages Display Error meaning and description Error: Flap open (displayed after instrument has been powered on) The measurement chamber flap is not closed properly. Solution Close the measurement chamber flap. •...
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Error messages Display Error meaning and description Error: Flap open (displayed during measurement) The measurement chamber flap is not closed properly. Solution Close the measurement chamber flap. •...
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Error messages Display Error meaning and description Error: Flap not closed after blood application The measurement chamber flap was not closed properly after blood application; the measurement was not started in time. Solution Remove and discard the strip. Repeat the measurement using a new test strip. •...
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Error messages Display Error meaning and description Error: Internal error (example shown: 142) The instrument has detected an internal error. Solution Power the instrument off and on again. • Clean the strip guide and optics area. If the error still persists, the instrument is defective. •...
05213312160 Accutrend Cholesterol Control Control solution to be used with Accutrend Cholesterol test strips 05219957001 Accutrend Plus instrument kit Meter kit 05346754160 Product limitations Please read the insert packaged with the test strips or control solutions for detailed information on product data...
Further information Product specifications Operating conditions and technical data Temperature range for Cholesterol: 18–30 °C measurement Glucose: 18–32 °C Relative humidity 10-85 % Measurement range Blood glucose: 20–600 mg/dL Cholesterol: 150–300 mg/dL Memory 100 measured values, optional with date, time and additional event information, per test parameter Battery operation 4 x AAA 1.5 V alkaline batteries...
Product specifications Sample material Sample type Fresh capillary blood (for detailed information see package insert) Sample volume A free hanging drop of blood Interactions See test strip insert Storage and transport conditions Temperature range –25 °C to +70 °C (for meter only) Relative humidity 10 to 85 % (no condensation) Disposal of instrument, strips, lancets and batteries...
Product specifications • Consider recycling of the meters and batteries at an appropriate facility. Be aware the meter is potentially hazardous electronics scrap (e-scrap) and should be disposed of accordingly. The batteries are potentially hazardous also and should be disposed of accordingly. •...
Alphabetical index Alphabetical index Capillary blood ............67 Addresses Service information ........114 recommendations for collection ....67 Cleaning ............97–101 cleaning agents ..........97 Batteries ..............28 instrument components ......98–99 inserting............. 28 optical measuring system ......100 disposal of ............. 113 Code Battery compartment lid ........
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Alphabetical index Date..............38–40 Lancing device ............. 67 Date format ............37 LED (light-emitting diode) ........ 12 Display ..............21 symbols ............. 24–25 Display of results .......... 74, 91 M button ..............21 Display test ............55 Measurement ..........51–86 Disposal ..............
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Alphabetical index Operating the instrument ......31–35 Settings ............32–43 Ordering information ........111 date ..............38 date format ............37 general procedure ........33–36 Power supply ............26 overview ............32 Protection against infections ......14 beeper ............... 43 time ..............
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Alphabetical index Time ................. 42 Time format ............41 Transport conditions ........113...
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US 5,463,467; US 5,424,035; US 5,334,508; US 5,206,147; US 5,240,860; US 5,382,523; US 5,521,060; US 5,268,269; US 6,506,575; US 5,281,395 0123 ACCU-CHEK, ACCU-CHEK MULTICLIX, ACCUTREND, COBAS, and SAFE-T-PRO are trademarks of Roche. Manufactured for and distributed in the U.S.A. by:...
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