CoaguChek INRange D R AF T -C O N FI D EN TI AL ® Coagulation Monitoring System User’s Manual
© 2014 Roche Diagnostics GmbH TI AL The contents of this document, including all graphics, are the property of Roche Diagnostics. No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics. Roche Diagnostics has made every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing.
Introduction N FI D EN TI AL Before you start..........................................................................................................................................................9 Intended use.................................................................................................................................................9 PT time........................................................................................................................................
Reviewing and Handling Data D R AF T -C O N FI D EN TI AL Reviewing test results........................................................................................................................................... 56 Displaying reports on the meter....................................................................................................................... 58 Displaying a Trend report................................................................................................
Reminders and Meter Settings O N FI D EN TI AL Setting up reminders............................................................................................................................................. 79 New reminder............................................................................................................................................ 80 Editing or deleting a reminder........................................................................................................
Other Functions and Troubleshooting EN TI AL Other functions.....................................................................................................................................................111 About (version and firmware)...........................................................................................................112 Clear Memory..........................................................................................................................................
General Product Information O N FI D EN TI AL Ordering....................................................................................................................................................131 Product limitations.................................................................................................................................131 Operating conditions and technical data......................................................................................
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Introduction Before you start AL Intended use It is not intended for use in the professional setting. CoaguChek INRange User’s Manual Introduction D R AF T -C O N FI D EN TI The CoaguChek® INRange system (CoaguChek INRange meter and CoaguChek XS® PT test strips) measures blood-clotting time (prothrombin time or “PT”) using fresh capillary blood from the fingertip.
PT time EN TI AL A PT test is often called an INR test. The International Normalized Ratio (INR) is a way of standardizing the results of prothrombin time tests because there are different test methods. INR enables you and your doctor to understand your coagulation results even when they come from different labs using different test methods. D Prothrombin time can also be expressed as %Quick or in seconds.
TI AL Self-monitoring and self-adjustment of oral anticoagulation therapy using coagulation values determined with the CoaguChek INRange system may only be undertaken after consultation with your doctor and comprehensive instruction by a qualified healthcare professional. CoaguChek INRange User’s Manual This manual contains all the information you need to operate and care for the CoaguChek INRange System. Please read this entire manual carefully before you use the meter.
The CoaguChek INRange System AF T R D Introduction -C O N FI D EN TI AL The CoaguChek INRange System makes coagulation testing easy. The graphical user interface of the CoaguChek INRange meter guides you through the test step by step. The code chip accompanying the test strips contains lot-specific information about these test strips, including calibration data that allow the correct results to be calculated, and the expiry date for the test strips.
AL If you have any questions about the CoaguChek INRange meter, please contact your local customer support and service center. You will find contact details on page 135. CoaguChek INRange User’s Manual Introduction D R AF T -C O N FI D EN TI Please note: Before you use the meter for the first time (i.e. after you have first inserted the batteries), you must set the date and time correctly to allow you to carry out measurements properly.
Test principle AF T R D Introduction -C O N FI D EN TI AL The CoaguChek XS PT test strip contains a lyophilized reagent (reagent in dried form). The reactive components of this reagent consist of thromboplastin and a peptide substrate. When a sample is applied, thromboplastin activates coagulation, which leads to the formation of thrombin. At the same time the meter starts to measure the time. The enzyme thrombin cleaves the peptide substrate, generating an electrochemical signal.
Contents of the pack CoaguChek INRange meter • 4 alkali-manganese batteries, 1.
Operating conditions AL To ensure that your CoaguChek INRange System functions properly, please observe the following guidelines: Only use the meter at a temperature between 15 °C and 32 °C. • Only use the meter at a relative humidity between 10% and 85%. • When testing, place the meter on a level, vibration-free surface or hold it so it is roughly horizontal. FI D EN TI • If the meter is to remain unused for a longer period of time, keep it in the carrycase supplied.
Quality control AL The CoaguChek INRange System has a number of inbuilt quality control functions such as: TI A check of the electronic components and functions every time the meter is turned on. EN A check of the test strip temperature while a test is in progress. FI D A check of the expiry date and lot information on the test strip. CoaguChek INRange User’s Manual Introduction D R AF T -C O N A quality control function is incorporated into the test strip.
Important Safety Instructions and Additional Information EN TI AL This section explains how safety-related messages and information related to the proper handling of the system are presented in the CoaguChek INRange User’s Manual. Read these passages carefully. AF T R WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
NOTICE AL Indicates a hazardous situation which, if not avoided, may result in damage to the system. CoaguChek INRange User’s Manual Introduction D R AF T -C O N FI D EN TI Important information that is not safety relevant is presented against a colored background (without a symbol). Here you will find additional information on correct use of the meter or useful tips.
The CoaguChek INRange Meter Overview of the meter elements AL Overview of the meter elements (front) TI A Display Shows menus, results, messages and results recalled from memory. EN B Back button Exit the currently displayed menu. C Arrow up/down button Move or scroll up/down in a screen. FI D Enter button (Power on) Confirm the currently selected option or perform a function. Also used to power the meter on and off. O N C D A D -C B F Test strip guide Insert the test strip here.
Overview of the meter elements (back and sides) G Battery compartment cover Covers the battery compartment (four 1.5 V alkali-manganese dioxide batteries type AAA). TI AL G EN H Code chip slot Insert the code chip here. CoaguChek INRange User’s Manual Introduction D R AF T -C O N I FI H USB port For wired communication and data transfer to a computer.
Batteries TI AL To save power, the CoaguChek INRange meter automatically turns itself off after 2 minutes unless a button has been pressed or a new test strip has been inserted. When the meter turns itself off, all results obtained up to that point remain in memory. EN When the Main Menu screen is displayed, the meter indicates the battery power level on the top right of the display. The battery symbol is divided into four segments which correspond to the battery power level.
AL Results together with the date and time, the comments and the download information are retained in the memory even when no batteries are inserted. All other settings are retained, too. EN TI Think of the environment. Dispose of used batteries sensibly. WARNING CoaguChek INRange User’s Manual Introduction D R AF T -C O N FI D Do not throw batteries onto a fire.
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Starting Up AL Before using the meter for the first time, carry out the following steps: Insert the batteries • Set the language • Set the current date and time • Select the coagulation unit in which the results are to be displayed EN D Insert the code chip (you can also carry out this step immediately before testing) CoaguChek INRange User’s Manual Starting Up D R AF T -C O N FI • TI •
Inserting the batteries EN TI AL When replacing the batteries you must insert the new batteries within 10 minutes of removing the old ones, to keep the date and time settings. If you take longer than this, you must re-enter the date and time. Only use alkaline-manganese dioxide batteries 1.5 V type AAA. D With normal use the batteries will last for approximately 60 tests. R AF T Think of the environment. Dispose of used batteries sensibly.
TI AL It is not recommended to use rechargeable batteries. In case you want to use them anyway, use AAA (Micro) 1.2 V NiMH HR6 batteries with a minimum capacity of 2500 mAh. Always use a battery charger recommended by the manufacturer. The number of tests that can be performed per battery charge is much lower than with regular batteries.
1 Turn the meter over. AL 2 Gently press the tab on the battery compartment cover towards the top of the meter and lift off the cover. EN TI 3 Insert the four batteries in the battery compartment as indicated. Pay attention to the positions of “+” (top of battery) and “–” (flat end). AF T R D Starting Up -C O N FI D 4 Re-attach the cover. Close the battery compartment by pushing the cover down until the tab snaps into place.
Initially setting up the meter EN TI AL When you power on the meter for the very first time, you will automatically be guided through the Language, Time & Date, and Units setup. If the meter automatically powers off before you have completed the settings (2 minutes after inserting the batteries), then: to power the D 1 Press the Enter button meter on (again). CoaguChek INRange User’s Manual Starting Up D R AF T -C O N FI The meter automatically displays the Language screen.
2 Use the Arrow up/down buttons to select your preferred language. The newly selected language is highlighted (blue). Arrow symbols on top and/or bottom of the screen indicate more entries above or below the currently visible part of the list. Language English AL Deutsch Français Español TI 3 Press the Enter button to confirm the selection, which is now marked by the green dot.
The meter now displays the screen for setting the time format. Time & Date 5 Use the Arrow up/down buttons to select the time format for the display (24 hour or 12 hour am/pm). The newly selected format is highlighted (blue). 12 hr Format TI AL 24 hr Format EN 6 Press the Enter button to confirm the selection, which is now marked by the green dot. Next D 7 Press the Enter button again to save the setting. The screen for setting time and date follows next.
8 Use the Arrow up/down buttons the current hour. Time & Date 17 13 : 45 2015 Sep TI 10 Proceed with setting the remaining fields. The Enter button always confirms a setting (and highlights the subsequent field, if available), the Back button allows you to jump back to the previous field. EN 2015 Sep 9 Press the Enter button to confirm the hour. The next input field (minutes) will be highlighted.
Select the preferred coagulation unit (for displaying a test result) as the last step of this initial setup process. The currently active unit is shown by a green dot. Units INR AL %Q 11 Use the Arrow up/down buttons to select your preferred unit. The newly selected unit is highlighted. Sec TI Main Menu EN 12 Press the Enter button to confirm the selection, which is now marked by the green dot. Test My Data D Reminders 13 Press the Enter button selected unit.
Code chip EN TI AL The code chip provides the meter with important information which it needs to perform the coagulation test. The chip contains information about the test method, the lot number and the expiry date. The meter is ready to use once the code chip has been inserted. AF T R Once the code chip information has been read by the meter, it will be stored for future use. You may remove the code chip then. Up to 5 code chip data sets can simultaneously be stored in the meter.
Inserting the code chip AL 1 Remove the old code chip, if one is inserted in the meter. Discard the old code chip with your household waste. CoaguChek INRange User’s Manual Starting Up D R AF T -C O N FI D EN TI 2 Slide the new code chip into the slot on the side of the meter as shown until you feel it snap into place.
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Testing a Capillary Blood Sample What you need CoaguChek INRange meter • The code chip already inserted in the meter (each test strip container has its own code chip) • Test strips belonging to the code chip mentioned above Lancet (e.g. CoaguChek Softclix Lancet) • Lint-free cloth or paper tissue D R AF T -C O N • CoaguChek INRange User’s Manual Testing a Capillary Blood Sample D Lancing device (e.g.
Important notes close the container immediately after having removed a test strip. • operate the meter at an ambient temperature between 15 °C and 32 °C. • place the meter on a level, stable surface (table) or hold it so it is roughly horizontal. • follow the information on correct handling of test strips in the package insert. FI D EN TI AL • keep the test strip guide and housing clean. Refer to the chapter Cleaning and Disinfecting the Meter and the Lancing Device.
Never … store the meter at extreme temperatures. • store the meter in damp or humid conditions without protection. • remove or insert the code chip while the meter is performing a test. • touch or remove the test strip during a test. • wait more than 15 seconds after lancing the fingertip before applying the blood. add more blood after the test has begun. • perform a test with a drop of blood from a previous puncture.
Getting a good capillary blood sample To get a suitable drop of blood: Wash your hands in warm water and dry thoroughly. AL • TI WARNING EN Residues of water on the skin can dilute the drop of blood and so produce false results. D Immediately after lancing, massage gently along the side of your finger to obtain a sufficiently large blood drop without pressing or squeezing too hard. R AF T -C O N FI • Let your hand hang at your side before lancing your finger.
Preparing to test 1 Have the test strip container to hand. TI AL 2 Make sure that the code chip belonging to these test strips is available or the information has previously been stored in the meter. EN 3 Prepare the lancing device by inserting a fresh lancet. CoaguChek INRange User’s Manual Testing a Capillary Blood Sample D R AF T -C O N FI D Do not lance your finger until asked to do so further on in this description.
Performing a test AL 1 Wash your hands with soap and warm water. Dry them thoroughly. WARNING TI Residues of water on the skin can dilute the drop of blood and so produce false results. R AF T -C O N FI 3 Power the meter on by pressing the Enter button . Alternatively, you can insert a test strip to power it on, which will put the meter – after completing the startup – into test mode directly.
4 Check the battery level during startup (or in the Main Menu afterwards). AL If the meter displays a Battery Low message, you can still perform up to 3 tests. Replace the batteries as soon as possible. CoaguChek ® EN TI 5 Check that the date and time are correct. Correct any wrong entries as described from page 89 onwards.
The test strip symbol prompts you to insert a test strip. TI NOTICE AL 7 Remove a test strip from its container. Immediately after removing a test strip, close the container again with the stopper. 9 Slide the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep tone indicates that the meter has detected the test strip. (Unless you have disabled the beeper in the Settings menu.
• The meter reads the strip information (provided by the barcode on the test strip) and checks if it matches code chip information already stored in the meter. • If you haven’t inserted the code chip yet or in case of a mismatch, you will be prompted to insert the correct code chip. • When the test strip check has been completed successfully, the meter indicates that the test strip is warming up. Test AL Reading strip... O -C AF T Test R Ready D EN N Test Test strip warming up...
10 Now lance the side of a fingertip with the lancing device. AL We recommend obtaining the capillary blood from the side of the fingertip as this causes least pain. EN TI 11 Massage the lanced finger until a drop of blood is formed. Do not press or squeeze the finger. FI N O -C AF T R D Testing a Capillary Blood Sample D 12 Apply the first drop of blood from the finger to the test strip.
13 Apply the blood directly from the finger to the semicircular, transparent sample application area of the test strip. EN TI AL Alternatively, you can touch the blood drop against the side of the sample application area (instead of applying it to the center from above). The test strip draws up the blood by capillary action. D R AF T -C O N Apply the blood drop to the test strip within 15 seconds of lancing the fingertip.
You hear a beep tone when you have applied enough blood (if you have activated the beeper function). The blood drop symbol disappears and the test starts. Test AL Blood Applied Do not add more blood. Do not touch the test strip until the result is displayed. TI Automated quality check... EN The meter now performs an automatic quality control check on the test strip. Following a successful outcome of the quality control check, the coagulation measurement starts.
The result is displayed in the unit you chose when setting up the meter. It is automatically saved to memory. Test 17:03 17 Sep 2015 2.8 INR AL When interpreting your result, please also read the test strip package insert carefully. EN TI If you wish, you can add up to six predefined comments to a test result. Comments can provide, for example, additional information about the test conditions or your general state of health.
14 To add a comment, use the Arrow up/ down buttons to highlight Add Comment. Test 17:03 17 Sep 2015 2.8 INR to proceed to AL 15 Press the Enter button the comment list. Add Comment Main Menu EN TI 16 Use the Arrow up/down buttons to highlight the comment(s) you wish to apply. Text 17 Press the Enter button to confirm the currently highlighted comment. A green checkmark appears behind each selected comment.
Text 20 The next screen displays a list of all previously selected comments. Check if the list is correct, and use the Arrow up/down buttons to highlight Confirm. Test Result: 2.8 INR Text Pre-operation Test 21 Press the Enter button to save the selected comments with the test result and exit this menu. Result: 2.8 INR Comments Post-operation Illness Missed medication Medication change EN The result screen now shows the Comment symbol . The test is completed.
22 Remove the test strip from the test strip guide. until AL 23 Press and hold the Enter button the meter powers off. TI 24 Discard the used test strip with your regular household waste. EN WARNING FI N O -C AF T R D Testing a Capillary Blood Sample D Dispose of used lancets carefully (e.g. use a sturdy sharps container with lid) so that the needles cannot cause injury to yourself or to others.
Notes concerning the results display Test All values that lie within the set target range are marked with a green bar. • If your results are displayed in INR and you have activated the detailed result format (as shown in the first screen on the left), values that are above the last measured test result are flagged with an up arrow. Results that are below the last measured test result are flagged with a down arrow. 17 Sep 2015 TI 2.8 INR AL 17:02 Test • 17 Sep 2015 N 1.
AL The target range is the range that you have agreed with your Healthcare Professional. Your test result should fall within the target range. EN TI The measuring range refers to the measuring range of the system itself and is defined by the technical limits of the meter and test strip. FI INR: 0.8–8.0 • %Q: 120%–5% • Sec: 9.
Reviewing and Handling Data AL The CoaguChek INRange meter lets you store, review, and manage test results in several ways: Store and review up to 400 test results including additional information and comments. • Display result reports as graphics or tables directly on the meter. EN N O -C AF T R D CoaguChek INRange User’s Manual • Transfer data to a dedicated USB or Bluetooth enabled device for medical communication, e.g., to your physician or healthcare provider (data transfer).
Reviewing test results 1 Power the meter on by pressing the Enter button . Wait until the Main Menu is displayed. AL Main Menu Test 2 Use the Arrow up/down buttons select My Data. TI My Data Reminders 3 Press the Enter button Data menu. EN Settings Other My Data to open the My D 4 Select Review Results and press the Enter button to display the results list. FI 17 Sep 2015 Review Sep Results All stored test results are displayed in a list with the most recent at the top.
Text 5 Use the Arrow up/down buttons scroll through the list. Review Results 05 Jul 2015 2.8 INR 29 Jun 2015 2.4 INR Review Results 17 Sep 2015 EN 2.6 INR 2.9 INR 7 Use the Back button results list. D R AF T -C O N FI Illness Medication change CoaguChek INRange User’s Manual to return to the D 15 Jun 2015 The test result will be displayed, along with the comments (entered at the time the test was performed) Reviewing and Handling Data 2.6 INR TI 2.
Displaying reports on the meter AL The CoaguChek INRange meter offers two kinds of inbuilt reports, which can be displayed directly on the meter: Trend: a graphical or tabular report allowing a linear, time-based analysis of stored test results. • Target: a graphical or tabular report allowing a statistical analysis of stored test results.
Displaying a Trend report 1 Power the meter on by pressing the Enter button . Wait until the Main Menu is displayed. Main Menu AL Test 2 Use the Arrow up/down buttons select My Data. My Data TI Reminders 3 Press the Enter button Data menu. EN Settings Other My Data O Text Trend -C Reports N Target 90 Days D R INR AF T Average: 2.
Text Trend Trend 90 Days 90 Days Average: 2.5 INR All test results stored within a selected period of time will be displayed in the chart as linear values. Each test result (represented by the symbol) is plotted along the time axis according to the time when the test was performed. All test results are connected by a line. This creates (angular) “curves” which, together with the actual test result entry, allow you to obtain a detailed analysis of individual results and trends. Average: 2.
Text Text Trend Trend 90 Days 60 Days Test results above or below the measuring range are marked accordingly. If the selected period of time contains no test results, no graph will be displayed. AL Average: 2.5 INR Due to an incorrect time setting a test result may be stored with a date in the future. The example on the lower left shows a test performed after inadvertently setting the date to the next year, and setting the date back to the correct year afterwards.
Displaying a Target report The Target report is only available if you have set and enabled an INR target range (see “Set Targets” on page 93). Main Menu AL Test 1 Power the meter on by pressing the Enter button . Wait until the Main Menu is displayed. My Data TI Reminders EN Settings 2 Use the Arrow up/down buttons select My Data. Other My Data D 3 Press the Enter button Data menu.
Text The percentage of values above, within and below the set target range will be displayed as a pie chart. The average (numerical) value of the selected time period is also displayed. If the selected period of time contains no test results, no graph will be displayed. Target 90 Days AL Average: 2.5 INR Above Within TI 5 Use the Arrow up/down buttons to select the time period you want to evaluate.
Data transfer • data backup EN further evaluation of stored test results in suitable computer applications FI AF T -C O N Neither USB nor Bluetooth selected. Check Settings. R The preferred method (USB/Bluetooth) used for data transfer has to be selected in the meter settings, before transferring data for the first time. Otherwise a corresponding message will be displayed. Both methods will be described separately on the following pages.
Data transfer via USB 1 Power the meter on by pressing the Enter button . Wait until the Main Menu is displayed. Main Menu AL Test 2 Use the Arrow up/down buttons select My Data. My Data TI Reminders 3 Press the Enter button Data menu. EN Settings Other My Data O Text Data Transfer -C Reports N Target D R AF T Connect USB to Meter & PC CoaguChek INRange User’s Manual Reviewing and Handling Data D The meter waits now for a connection to be established.
EN TI AL For connecting the meter to a computer, you will need a suitable USB cable (included in the kit). Connect the micro USB type B plug to the meter (the USB port is located on the right-hand side of the meter) and the USB type A plug to the computer. In order to transfer data, always connect the cable to the meter first and then to the computer. Data transfer must be actively triggered by the computer application or device app used for reading the stored data.
Data transfer via Bluetooth 1 Power the meter on by pressing the Enter button . Wait until the Main Menu is displayed. Main Menu AL Test 2 Use the Arrow up/down buttons select My Data. My Data TI Reminders 3 Press the Enter button Data menu. EN Settings Other My Data The meter waits now for a connection to the paired device to be established.
Text When the connection has been established and the download command was sent, the meter informs you about the progress. Data Transfer Transferring data... Depending on the software you are using an information screen may appear after completing the data transfer. It may contain, e.g., information about available software updates or a change of settings applied to the meter. TI AL Data... Data Transfer FI O Update 17. Sep 2015 N INFORMATION OK R AF T -C Target range setting changed.
Displaying reports on a computer The reports displayed on the meter (see page 58 ff.) can also be displayed on a computer. Opening these reports on an Internet browser provides additional advantages like more detailed information, the ability of printing, and storing results to file for further evaluation. You do not need an Internet connection, all report data is stored on and retrieved from the meter. Reports can only be used via an USB connection.
5 Connect the meter to the computer via USB cable. AL The display shows “Connected” when the connection has been established. EN TI 6 If this has not been done automatically, open a window on your computer which displays the contents of the meter (as a removable disk drive). 7 Double click on START.HTM to open the file in your standard Internet browser. D Text Reports FI 8 After you have finished using the embedded reports, unplug the USB cable from the meter and the computer.
Security settings in the Internet browser The settings of your Internet Browser can have an influence on working with reports. D R AF T -C O N FI In many cases, you can change the security settings for using the Internet and working with reports (e.g. at user login to the PC or by defining user profiles in the browser). CoaguChek INRange User’s Manual If you choose the Internet browser security settings appropriately (e.g.
Reports overview A report displayed in your Internet browser contains the following elements: A -C O N FI B Report Content The page body contains the Trend Graph, the Target Graph, and a chronological list of Results. R AF T B Language, preferred units, and your personal therapeutic range will displayed as set in the meter. The target range is only available if you have selected the unit INR in the meter settings.
Time period EN TI AL Starting from your most recent test result, you can choose a Time Period going back 60, 90, 120, or 180 days. This setting is applied to both the Trend and Target graph. Trend graph CoaguChek INRange User’s Manual Vertical lines on the Trend graph mark the beginning of each week. Reviewing and Handling Data D R AF T -C O N FI D All test results stored within a selected period of time will be displayed in the chart as linear values.
Target range display AL The green area behind the curve marks the INR target range (if set, otherwise not displayed). You may set the Target Range Display to: Constant: the current target range set in the meter is applied to all results in the selected time period. • Individual: the green bar shows the target range valid at that point in time. FI The percentage of values above, within and below the set target range will be displayed as a pie chart.
List of results AL All test results are listed in chronological order, with the latest result on top. The list contains the following columns: Date and Time • PT Coagulation (INR) The result value is shown in INR. If the result is outside the measuring range, either LOW or HIGH will be shown. • Target range (INR) The target range valid at that point in time. If the result is outside the target range the cell is colored blue (above) or yellow (below).
Printing reports All the reports displayed on the screen can also be printed out at once. EN TI AL In order to achieve the best results, use the print button on the report header. Do not use the integrated print function of the browser. 1 Click the print button header. in the report FI N O R AF T -C 3 Start the printing process. D Reviewing and Handling Data D 2 Select the desired printer from the print dialog box, and adjust print parameters as needed, depending on the available options.
Using data in external applications TI AL For evaluating test results using other software, you can save the data as a *.csv file. The file extension CSV stands for Comma Separated Values. These files can be used by various applications, for example a text editor or a spreadsheet application. D R AF T -C O N FI 1 Click the Save file button header. CoaguChek INRange User’s Manual in the report 2 Select the desired save options in the following dialog box.
EN TI AL The saved file is handled by the system like a download performed by the Internet browser, the corresponding settings apply. This will, for example, determine if the file is just stored or directly opened in an application. If saving the *.csv file does not work as expected check the relevant system and browser settings. FI Serial number of the meter Date and time of data download to the computer (for creating this *.
Reminders and Meter Settings Setting up reminders D R AF T -C O N • CoaguChek INRange User’s Manual reminders Medication • Appointment • Other reminders reminders reminders Each reminder can be scheduled as single reminder, or as recurring reminder (daily, or in 1-4 week intervals). Reminders and Meter Settings Test FI • D EN TI AL The CoaguChek INRange meter lets you set up reminders, that work just like an alarm clock telling you it’s time for an action.
New reminder For setting up a new reminder: Main Menu 1 Power the meter on by pressing the Enter button . Wait until the Main Menu is displayed. AL Test My Data Reminders TI 2 Select Reminders and press the Enter button to open the corresponding menu. Other EN Settings Text Reminders 3 Select New and press the Enter button to set up a new reminder.
4 Use the Arrow up/down buttons to set the desired type (test, medication, appointment, other). Reminders Select reminder type Once AL 5 Press the Enter button to confirm the selected type. The next reminder para meter (interval) will be highlighted. 6 Use the Arrow up/down buttons to set the desired interval (once, daily, every 7, 14, 21, or 28 days). 17 Reminders EN Select frequency Next D 7 Press the Enter button to confirm the selected interval.
After entering and confirming the day, you are prompted to set the audio signal for the reminder. Reminders Set day of week 7 Days AL 9 Select the desired Reminder Tones, which may, for example, help you to acoustically distinguish between reminder types. Press the Enter button to confirm your selection. A green dot marks the selected tone. Reminder Tones EN Monday TI 13 : 45 Next Marimba D 10 Press the Enter button selection and proceed.
Text The newly set reminder is now shown in the list of reminders. You can now Reminders Current Reminders • set another New reminder 13:45, Thu 7 Days • Edit/Delete the existing reminder • exit the Reminders menu with the Back button and return to the Main Menu.
Editing or deleting a reminder Text Reminders For editing or deleting a reminder: Text Current Reminders 1 Select Edit/Delete and press the Enter button to proceed. Edit Reminders 13:45, Thu 7 Days AL 17:30, 17 Sep 2015 17:30, 17 Sep 2015 2 Select the desired reminder and press the Enter button to confirm your selection. A green dot marks the selected reminder. EN TI 13:45, Thu 7 Days 3 Select Edit or Delete and press the Enter button to proceed.
Meter settings EN TI AL The initial meter setup has already been finished after powering on the meter for the first time. Use the following descriptions to set up options that are not covered by the initial setup (like, e.g., the target range) or to edit settings already made.
Settings overview Set Targets TI EN D FI • • On Off • • High value Low value 60 days 90 days 120 days 180 days R AF T • • • • 24-hour format (24h) 12-hour format (12h) with a.m./p.m.
CoaguChek INRange User’s Manual TI EN Reminders and Meter Settings D R AF T -C O Data Transfer D Button Click FI Display Brightness Options • High • Medium • Low • Off • High • Medium • Low • On • Off • None • Bluetooth • USB N Setting Beeper Volume AL 87
Language 1 Select Language and press the Enter button to open the corresponding menu. Settings A green dot indicates which language is currently active. AL Language Time & Date Units TI 2 Use the Arrow up/down buttons to select your preferred language. The newly selected language is highlighted (blue). Arrow symbols on top and/or bottom of the screen indicate more entries above or below the currently visible part of the list.
Time & Date 1 Select Time & Date and press the Enter button to open the corresponding menu. Settings AL Language 2 Use the Arrow up/down buttons to select the time format for the display (24 hour or 12 hour am/pm). Time & Date TI Time & Date EN Result Format 3 Press the Enter button to confirm and save the setting. The screen for setting time and date follows next.
AL In order to ensure a correct time and date setting, the meter checks the date for plausibility.
Units 1 Select Units and press the Enter button to open the corresponding menu. Settings Units The currently active unit is shown with a green dot on the right side. Units %Q Result Format Sec 2 Use the Arrow up/down buttons to select your preferred unit. The newly selected unit is highlighted (blue). TI INR EN Time & Date AL Language Set Targets O -C AF T R D CoaguChek INRange User’s Manual again to save the A target range can only be set and used if the unit is set to INR.
Result Format TI AL Choose Detailed if you want to see your current result in relation to your previous result in the same screen. An up arrow indicates that your current result is higher, and a down arrow indicates that it is lower than your previous result (see page 53). 1 Select Result Format and press the Enter button to open the corresponding menu. EN Settings Result Format Detailed The currently active result format is shown with a green dot on the right side.
Set Targets AL A target range can only be set and used if the unit is set to INR. EN TI A target range (or therapeutical range) defines the minimum and maximum values which should be achieved during the therapy. Reports and statistics can then include information about values within, above or below this target range.
The current activation status is shown with a green dot on the right side. Set Targets On A newly set or edited target range is only valid for tests performed after this setting was done, and will not affect test results already stored in memory. TI AL Off EN 5 Use the Arrow up/down buttons select On or Off. Next to FI again to proceed R AF T -C O N 7 Press the Enter button to the next step.
If you have selected the option Off, the Set Targets setup ends here. If you have selected the option On, proceed as follows: Set Targets On 8 Select the value you wish to set and press the Enter button to proceed. AL Off TI 9 Use the Arrow up/down buttons the desired value. 11 Repeat the last steps to set the second value as well. -C High Value 6.0 D R AF T Confirm CoaguChek INRange User’s Manual 12 Select Confirm and press the Enter button to save the settings.
Beeper Volume AL If the beeper is activated, the meter always beeps when an action is taken, for example a test strip is inserted or sufficient sample has been applied. D EN TI The beeper volume can be set or deactivated. However, in case of an error the meter will always beep for safety reasons, even if you have set the beeper function to Off.
Display Brightness Settings 1 Select Display Brightness and press the Enter button to open the corresponding menu. Text Display Brightness Medium Beeper Volume Low The currently set display brightness is shown with a green dot on the right side. TI High Set Targets 2 Use the Arrow up/down buttons to select the desired display brightness. The display will temporarily switch to the currently highlighted brightness.
Button Click The meter can be set to play a click sound, whenever you press a button. Settings AL To set the button click: 1 Select Button Click and press the Enter button to open the corresponding menu. TI Text Button Click ON Set Targets OFF The current status is shown with a green dot on the right side. D Result Format EN Units 2 Use the Arrow up/down buttons select On or Off. FI Beeper Volume 3 Press the Enter button to confirm the selection, which is now marked by the green dot.
Data Transfer EN TI AL The CoaguChek INRange meter is able to communicate with a computer and/or other devices either via USB or a wireless Bluetooth connection. Using the Data Transfer option (see chapter Data transfer starting on page 64) enables the transfer mode (USB or Bluetooth) preselected here. To set up data transfer: 1 Select Data Transfer and press the Enter button to open the corresponding menu.
If you have selected None or USB, data transfer setup ends here. Paired device: My Smartphone Activating Bluetooth Delete pairing and pair with another device? EN Yes FI D BTPairing Smart 5 Enter the displayed code on the device you want to pair the meter with. Pairing Information: N 987654 O Text Pairing in Text Progress -C Pairing 6 Press the Enter button to confirm and finish the pairing process.
NOTICE AL Overview EN TI To avoid malfunction of the meter, follow the procedures below to clean and disinfect the meter and the lancing device. Make sure the meter is turned off. • Do not use sprays of any sort. Ensure that the cloth or cotton swab/bud is only damp, not wet, to protect against moisture entering the meter. D R AF T -C O N FI • D • CoaguChek INRange User’s Manual To prevent soiling the meter, apply blood via side-dosing directly from fingertip.
Cleaning is the removal of dirt from the meter or lancing device. EN TI AL Disinfecting is the removal of most, but not all, disease-causing and other types of microorganisms (bloodborne pathogens) from the meter or lancing device. Clean and disinfect the meter and/or the lancing device to remove visible dirt or other material on a regular basis.
Gently wipe the meter’s surface with one of these cleaning agents: a soft cloth slightly dampened (not wet) with a small amount of liquid soap diluted in water • Rubbing alcohol (70% ethanol or isopropyl alcohol) • Alcohol-based disinfectant (a mixture of 1-propanol (400 mg/g), 2-propanol (200 mg/g) and glutaraldehyde (1.0 mg/g)) FI D EN TI AL • D R AF T -C O N • CoaguChek INRange User’s Manual Disposable wipes (containing quaternary ammonium compounds up to 0.
Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing. • Do not let liquid accumulate near any opening. EN TI AL • NOTICE R AF T -C O N FI D Ensure that no liquid enters the meter when you clean the exterior. If moisture enters the meter, it may cause malfunction of the instrument.
1 With the meter turned off, wipe the meter’s exterior clean. AL 2 With a fresh dry cloth or lint-free tissue, wipe away residual moisture and fluids after cleaning the housing. EN TI 3 Allow wiped areas to dry for at least 10 minutes before performing a test. D Cleaning the test strip guide D R AF T -C O N FI 1 Remove the test strip guide cover to clean it. (Use your thumbnail to open the cover of the test strip guide by pressing its front edge upward.
3 Hold the meter upright with the test strip guide facing down. Clean the easily accessible white areas with a moistened cotton swab/bud. • Ensure the swab/bud is only damp, not wet. Wipe away residual moisture and fluids. EN TI AL • NOTICE Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. • Do not insert any objects in the test strip guide. Doing so may damage the electrical contacts behind the test strip guide.
4 With the cover off, let the test strip guide dry for at least 10 minutes. EN TI AL 5 After this time, re-attach the test strip guide cover to the housing. Make sure that the cover is properly closed. You will hear it snap into place. FI D Cleaning and Disinfecting the Lancing Device NOTICE Do not throw away the lancing device cap after each use. Use approved cleaning and disinfecting products on it. • Remove the lancet before cleaning and disinfecting the lancing device.
Clean the lancing device to remove visible dirt or other material prior to disinfecting. • Clean and disinfect the lancing device before allowing anyone else to handle the lancing device, for instance, if you have someone assisting you. Do not allow anyone else to use the lancing device.
The entire lancing device surface • The cap AL • TI How to clean and disinfect the lancing device EN 1 Wash hands thoroughly with soap and water. D R AF T -C O N FI D 2 Wipe the entire surface of the lancing device and the inside of the lancing device cap with the approved cleaning and disinfection product. Always use the same product for both cleaning and disinfecting. CoaguChek INRange User’s Manual 3 Dry the lancing device and cap with a soft cloth or gauze.
DO NOT get any moisture into the opening around the button. • To avoid damaging the lancing device and stop it from working properly make sure you follow the above recommendations.
Other Functions and Troubleshooting Other functions TI AL The Other menu of the meter contains functions relevant for service and troubleshooting purposes: Version information and firmware update • Clear memory (deleting data and settings) • Meter log Text Test -C O Other About Reminders Clear Memory Settings Meter Log Other AF T My Data Display Test Firmware Update 17 Sep 2015 R 17:03 D Sep CoaguChek INRange User’s Manual Preceding to all of the following descriptions (not r
About (version and firmware) TI AL In case of technical problems the firmware version is an important information for the Roche customer support . Sometimes problems can be solved by applying a firmware update. The About screen provides such information. Text 1 Select About and press the Enter button to open the corresponding menu. EN Other Text The serial number, firmware version, hardware information and production date is displayed. Clear Memory Meter Log 0000000225 00.07.
Clear Memory NOTICE FI The following data will be cleared: D R AF T -C O N • CoaguChek INRange User’s Manual Test results • Error log • Stored code chips • Reminders The setup will be reset to the default settings. The meter turns off. When the meter is turned on again, you will first need to perform an initial setup (see page 29).
Text For clearing the memory: Other 1 Select Clear Memory and press the Enter button to proceed. About Clear Memory AL Clear Memory Firmware Update TI Display Test 2 Select YES and press the Enter button to proceed. Text 3 Select YES again and press the Enter button to clear all data from memory.
Meter Log Text The Meter Log is another helpful source of information when contacting Roche Diagnostics customer support. The meter stores a list of all warnings, maintenance and error messages. Other AL About Text Firmware Update 1 Select Meter Log and press the Enter button to proceed. Meter Log 2 Select the event you want to know details about and press the Enter button to proceed.
Display Test Text Other The Display Test lets you check the meter’s screen for proper functioning. In case you suspect the screen (or parts of it) to be defective, perform this display test. Display Test Clear Memory AL About Display test. Go through the four colored screens with OK. 1 Select Display Test and press the Enter button to proceed. TI Meter Log EN Display Test 2 Read the information screen and press the Enter button to proceed.
Firmware Update Text Other AL Performing a firmware update requires an update file (provided by Roche) to be available on your computer. You may have downloaded this file from the Roche website. About Firmware Update Display Test Connect USB to Meter & PC EN 1 Select Firmware Update and press the Enter button to start the update process. D Firmware Update TI Text Meter Log D R AF T -C O N FI 2 Connect the meter to the computer via USB cable.
Text Text Firmware Update 3 On the computer, open a window showing the content of this drive. Firmware Update Loading Update AL 4 Copy (or save) the required update file to this drive. For Firmware Update copy file to INRange-Drive EN TI The meter automatically recognizes the presence of an update file and starts performing the firmware update. Several screens inform you about the progress during installation. When the update has been completed successfully, the CoaguChek logo is displayed.
Troubleshooting AL The CoaguChek INRange meter continually checks its systems for unexpected and unwanted conditions. D R AF T -C O N FI Take the action suggested on screen to resolve the problem. If the problem (and the corresponding message) disappears, you may continue using the meter as desired. If the problem persists, contact Roche Diagnostics (see page 135). CoaguChek INRange User’s Manual For troubleshooting problems which are not indicated by a message see the following pages.
Errors and unusual behavior without error messages Possible solution Insert new batteries. Always replace all 4 batteries at the same time. Refer to the package insert for the test strips.
Symbols, Icons, Messages Symbols on packaging and meter D FI N O This product fulfills the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices. Catalogue number Consult instructions for use Caution, consult accompanying documents. Refer to safety-related notes in the manual accompanying this instrument. Manufacturer Temperature limitation (Store at) D The system fulfills the Canadian and U.S.
On the meter buttons the following symbols are used: Meaning Back button, used to exit the currently displayed menu or go back one step. Arrow up/down button, used to select elements, scroll up/down in a screen, or change numerical values. Enter button, used to confirm the currently selected option or perform a function. Also used to power the meter on and off.
Icons on the display Symbol Data icon, shown in main menu D R Reminder icon, shown in main menu EN D Appointment icon, shown in reminders Comment icon, shown with stored test results Upload icon, shown with stored test results after data transfer Radio button, shows the status of a selectable option (off/on) in meter setup screens Warning message Error message Symbols, Icons, Messages AF T -C O N Bluetooth logo, shown when starting a wireless data transfer and in data transfer setup USB sym
Symbol Meaning Maintenance message AL Meaning Settings icon, shown in main menu, and selected option (e.g.
Messages AL There are several kinds of messages which can appear on the meter: Reminders • Information • Maintenance • Warnings • Error messages D EN TI • CoaguChek INRange User’s Manual Symbols, Icons, Messages D R AF T -C O N FI The following section explains what you can do when such a message appears.
Reminders Reminders are a useful tool to schedule tests and other events. When a reminder becomes active, it automatically powers on the meter (if necessary), plays the corresponding sound and displays the reminder message (test, medication, appointment or other). You have two options: Medication Reminder 17:30, 17 Sep 2015 EN TI AL Reminder • Snooze FI D Confirm Select Confirm, and press the Enter button to confirm that you will perform the required action right now.
Information An information message informs you about what is happening in the meter or a problem that exists or may come up which requires you to do something soon. You can continue to use the meter. INFORMATION AL Batteries Low [I-01] TI Batteries are getting low. Replace batteries soon. EN 1 Read the whole information message. 2 Press the Enter button message. to confirm the D 3 Proceed with the current task.
Maintenance • You may not be able to perform a test because the code chip and the test strip lot don’t match. • The meter may detect a problem when performing a software self-check. TI The batteries are empty. Almost always, you can fix the problem by following the instruction in the maintenance message. You can insert new batteries or start the test again with a new test strip and the correct code chip. Or the meter often fixes a software problem itself when you power it off and on again.
Warnings A warning message draws your attention to a hazardous situation that could be a risk to your health if not corrected. The CoaguChek INRange meter will rarely display a warning message. However, if you do receive a warning message, pay close attention to it. Warning AL Sample Error [W-45] TI Unusual sample. Repeat test with fresh sample. If error persists, contact your healthcare professional without delay. EN 1 Read the whole warning message and the suggested action.
Error messages An error message appears if the meter has a problem that needs your attention and you might not be able to solve. The meter stops working. Error AL Meter Lifetime End [E-33] Maximum number of tests has been reached. Contact your healthcare professional or Roche Diagnostics. TI 1 Read the error message. EN 2 Take the action suggested in the message. D If the error persists, please contact your local Roche Diagnostics customer support (see page 135).
General Product Information Ordering AL Please contact your pharmacist or specialist supplier. REF/Catalog Number REF 0 4625358 REF 0 4625315 REF 0 3506509 … D R AF T -C O N Product limitations CoaguChek INRange User’s Manual Please read the information in the package insert supplied with the test strips for detailed product data and limitations.
Operating conditions and technical data TI EN Measuring range FI D Memory Interfaces O -C R AF T Safety class Automatic power-off Dimensions Weight N Battery operation D General Product Information +15 °C to +32 °C 10 to 85% (no condensation) 4.300 m Place the meter on a level, vibration-free surface or hold it so it is roughly horizontal. %Q: 120% – 5% SEC: 9.6 – 96 INR: 0.8 – 8.0 400 test results with date and time USB type B Bluetooth 4 x 1.
Sample material AL For information regarding sample type, sample size and interferences refer to the respective test strip package insert. TI Storage and transport conditions During measurements the meter itself may come into contact with blood. Used meters therefore carry a risk of infection. Please dispose of your used meter – after removing the batteries and cleaning the meter – according to the regulations applicable in your country.
For healthcare professionals AL Dispose of the meter in line with your facility’s procedures for dealing with potentially biohazardous waste. Disposal of used batteries EN TI Do not dispose of the batteries with normal domestic waste. N Please note that repairs and other modifications to the meter may only be performed by persons authorized by Roche Diagnostics.
Information service O -C AF T R D CoaguChek INRange User’s Manual General Product Information FI D EN TI Canada Roche Diagnostics 201 Boulevard Armand-Frappier Laval, Québec H7V 4A2 Coagulation Info-Line Telephone 1-877-426-2482 United Kingdom Roche Diagnostics Ltd. Charles Avenue Burgess Hill, RH15 9RY CoaguChek Careline 0808 100 7666 N Australia Roche Diagnostics Australia Pty Ltd.
Product Safety Information Bluetooth Wireless Technology TI AL The meter can utilize Bluetooth wireless technology to communicate and transfer information to other devices (e.g., computer or smartphone). N O -C AF T R D General Product Information FI D EN Bluetooth wireless technology is a form of radio frequency (RF) technology that operates in the unlicensed industrial, scientific, and medical band at 2.4 to 2.485 GHz.
Radio Frequency Communication AL The device complies with the United States Federal Communications Commission (FCC) standards. D EN TI The device complies with FCC Part 15 Rules. Operation of the device is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
TI AL The compliance mark indicates that the product complies with the applicable standard and establishes a traceable link between the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian and New Zealand market. The device has been tested and found to comply with the limits for a Class B digital device. The device generates, uses, and can radiate radio frequency energy.
Electromagnetic Compatibility CoaguChek INRange User’s Manual General Product Information D R AF T -C O N FI D EN TI AL 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.
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Index D Data transfer......................................... 64–68 Bluetooth.................................. 67–68 setup.................................................. 99 USB............................................. 65–66 Display............................................................ 20 brightness........................................ 97 test.................................................... 116 TI EN D N FI E Electromagnetic interference................
Q Quality control............................................. 17 AL TI EN D FI R off........................................................ 33 on........................................................ 29 D P Power AF T O Operating conditions................................ 16 Other (functions)............................ 111–116 R Reminder..................................................... 126 edit/delete....................................... 84 new.....................................
TI EN D FI N -C D R AF T T Temperature.......................................... 16, 38 Test............................................................ 37–54 blood sample.................... 40, 46–48 performing....................................... 42 preparing......................................... 41 result display........................... 49, 53 Test strip insertion........................................... 44 Test strip guide............................................
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AL TI EN D FI N Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.coaguchek.com 0 XXXXXXXXXX (01) 2014-XX EN O -C AF T ACCU-CHEK, COAGUCHEK and SOFTCLIX are trademarks of Roche.
