CoaguChek XS Plus System ® User Manual
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The CoaguChek XS Plus System The CoaguChek XS Plus System The CoaguChek XS Plus System is used to monitor coagulation (blood-clotting) values (prothrombin time, PT, Quick value) with CoaguChek XS PT test strips. Please note: This manual contains the information you need to operate and care for the CoaguChek XS Plus System. Please read this entire manual carefully before you use the meter.
The CoaguChek XS Plus System Introduction........................................................................................................................... 7 The CoaguChek XS Plus System....................................................................................................7 Test principle..........................................................................................................................................8 Contents of the pack.........................................
Testing a capillary blood sample....................................................................... 53 Important notes .................................................................................................................................53 Getting a good capillary blood sample ....................................................................................54 Getting a good test with venous whole blood ......................................................................
Introduction Introduction The CoaguChek XS Plus System The CoaguChek XS Plus System measures blood-clotting time (prothrombin time) for people who are taking anticoagulation medications, such as Coumadin® or warfarin. The CoaguChek XS Plus System measures blood-clotting time using blood from the fingertip or whole blood from a vein (nonanticoagulated venous whole blood). The CoaguChek XS Plus System quantitatively measures prothrombin (blood-clotting) time (PT/Quick value/INR).
Introduction Test principle The CoaguChek XS PT Test, used as directed with the CoaguChek XS Plus Meter, will provide an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin. In simple terms, blood works with the chemicals in the test strip to make a small electric current in the test strip that measures blood-clotting time.
The CoaguChek XS Plus System Safety Information Protection against infection Medical staff using the CoaguChek XS Plus System to perform tests on patients must be aware that any contact with human blood is a potential source of infection. n Use gloves. n Use a separate lancet and lancing device for each person. n Dispose of used lancets and test strips in a sturdy sharps container with a lid. n Follow all health and safety regulations applicable to your laboratory or practice.
Introduction Operating conditions To be sure that your CoaguChek XS Plus System functions properly, please observe the following guidelines: n Only use the meter at a room temperature between 59°F and 90°F (15°C and 32°C). n Only use the meter at a relative humidity between 10 and 85 percent. n When operating the meter using the power adapter, use only a voltage of 100 V to 240 V (± 10%), 50/60 Hz. n A touch screen makes the meter easier to operate.
Introduction Quality control The CoaguChek XS Plus System has a number of built-in quality-control functions. n A check of the electronic components and functions every time the meter is turned on. n A check of the test strip temperature while a test is in progress. n A check of the expiration date and lot information on the test strip carried out by the code chip. n A two-level, on-board quality control test and patient result determination within a single test chamber.
About this manual About this manual Manual format The layout of this operator’s manual has been specially designed to help you locate the most important information quickly and easily. All instructions that require you to actively do something, as well as very important information, appear on a blue background. This symbol draws attention to the possible risk of injury or of harm to your health. Example 1: The left column contains an illustration of the display screen.
About this manual Example 2: This column contains an illustration of the display screen. This column contains information linked to the display screen.
The CoaguChek XS Plus meter The CoaguChek XS Plus meter A B C F E D I F G H J 14
The CoaguChek XS Plus meter Meter elements overview A Touch screen Shows results, information, symbols and results recalled from memory. To select any of the screen prompts, touch the prompt lightly, holding until the prompt is selected. B On/Off button Press and hold this button until the meter turns on or off. C Test strip guide cover Remove this cover to clean the test strip guide. (REF 05039657001) D Test strip guide Insert the test strip here.
The CoaguChek XS Plus meter Power supply The CoaguChek XS Plus meter can operate with either the power adapter provided, batteries, or a special rechargeable battery pack (REF 04805640001). The CoaguChek XS Plus System uses four AA batteries. The batteries should last for about 60 tests, depending on the type of battery used. You should insert the batteries or optional rechargeable battery pack even when you use the power adapter.
Operating the instrument Operating the instrument Before using the meter for the first time, carry out the following steps: 1 Insert batteries* and/or connect the power adapter. 2 Set the current date and time. 3 Enter the settings of choice (language, unit of measure, user administration if applicable, etc.). * Instead of batteries, you can use a special rechargeable battery pack. If you choose this option, order the pack separately from Roche Diagnostics.
Operating the instrument Inserting the batteries 1 With the meter turned off, press the battery compartment cover release tab and slide the cover off. 2 Insert the four batteries in the battery compartment as indicated. (The CoaguChek XS Plus System uses AA batteries. The batteries should last about 60 tests, depending on the type of battery used.) 3 Slide the battery compartment back onto the meter and close it. The meter turns itself on after the batteries have been inserted.
Meter setup Meter setup Please note: If you have not set the date and time (after turning the meter on for the first time or because the batteries were removed from the meter for more than 10 minutes), you cannot perform a test. In that case, turning on the meter takes you immediately to the Setup mode, where you must set the date and time. Once the date and time are set, the meter automatically moves to the main menu, where you can start a test or enter more settings.
Meter setup Display field and symbols The screen prompts that appear during normal operation are shown here, along with their meaning. Error messages and the description of the symbols linked to them are provided in the chapter entitled Error messages.
Meter setup Symbol Meaning Apply blood sample (the time left to apply sample is counted down in the display) 180 SEC Apply QC sample (the time left to apply sample is counted down in the display) 180 SEC Insert the code chip QC %Q Sec INR Automatic quality control completed successfully Results are displayed as a Quick percentage value. Results are displayed in seconds. Results are displayed in INR units. Result in the chosen unit of measure is above the measuring range.
Meter setup Symbol Meaning Battery status: • When the batteries still have their full charge, all segments are lit. • Individual segments disappear one by one as the batteries become weaker. • When there is no segment remaining, you can no longer perform a test. However, test results are still saved in memory.
Meter setup Settings summary The diagram below shows all of the SETUP areas that can be accessed on the meter. Setup Screen Contrast Units Language Date/Time Sort Beeper Auto Off Computer Options ID Setup Admin.
Meter setup Group Subgroup Setting Values * SCREEN Contrast 0 - 10 (5 *) RESULT Units INR * INR/SEC INR/%Q Language Dansk Deutsch English * Español Français Italiano Nederlands Norsk Português Svenska Date/Time SET Date 01/01/2005 * SET Time 12:00 am * Date formats Day.Month.Year (12.06.
Meter setup Group Subgroup Setting OPTIONS Sort Beeper Beeper Values * Date/Time * Patient ID NUMBER Off LOW MEDIUM * HIGH Off * Key click Auto Off [minutes] On Off * 1 … (5)* … 10 15 20 25 30 40 50 60 Computer Active Inactive * * Settings that are in the meter when it leaves the factory are labeled with an asterisk (*).
Meter setup Group Subgroup Setting Values * ID SETUP Admin.
Meter setup Conventions used in this manual This manual refers to all the various operations of the meter. When discussing a particular operation, a picture guide will appear at the top of the page. This guide shows how to navigate to this particular operation from the meter’s main menu. For example: This picture guide shows you how to get from the main menu to the date/time setup section.
Meter setup Screen setup The Screen setup area contains the options for changing the way the display looks. Contrast Use this setup option to make the screen display easier to see, depending on the lighting conditions where you are. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup to call up the meter settings. Patient Test 2 F rom the Setup menu screen, touch Screen. Control Test Review Results Setup 09/16/2009 Setup Menu 3 F rom the Screen menu screen, touch Contrast.
Meter setup Units Use this setting to select the unit(s) of measure to be displayed with the results. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Screen. Control Test Review Results Setup 09/16/2009 Setup Menu 3 F rom the Screen menu screen, touch Result Units.
Meter setup Language Selection Use this setting to select the language for all displays (that contain text). Main Menu 1 Touch Setup in the main menu. 09:15 am 2 From the Setup menu screen, touch Screen. Patient Test 3 F rom the Screen menu screen, touch Language Selection.
Meter setup Language Dansk Deutsch English Español Français 09/16/2009 09:15 am 4 T ouch or to scroll to the language of choice on the screen. If the arrow is just an outline , this means the arrow is not active. On this screen, for example, there are no languages listed above “Dansk”. 5 T ouch the screen prompt to select the language of choice. Your selection is now displayed with a black background.
Meter setup Setting the date When you turn on the meter for the first time (or after a long period without power), the input field for the date automatically appears first. The date (and time) must be entered before the meter can be used further. If at a later time a date adjustment is needed, go to the Setup menu, then select the input field of choice. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Screen.
Meter setup Setting the time When you turn on the meter for the first time (or after a long period without power), the Setup menu appears automatically after you set the date. If at a later time a time adjustment is needed, go to the Setup menu, then select the input field of choice. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Screen.
Meter setup Setting the display options for date and time You don’t have to select display options for date and time, even though you must enter the date and time. However, if you want to reset the time and date formats, first go to the Setup menu. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Screen. Control Test Review Results Setup Setup Menu 09/16/2009 3 F rom the Screen menu screen, touch Date/Time.
Meter setup Options setup Sort Sort refers to the order in which measured and stored results are displayed when you use your CoaguChek XS Plus meter’s memory function. You can display stored results chronologically by date and time or by person, based on the patient ID. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Options. Control Test Review Results Setup 09/16/2009 Setup Menu 3 F rom the Options menu screen, touch Sort.
Meter setup Beeper Note: Your CoaguChek XS Plus meter can display information visually and alert you to special circumstances with a beeper.
Meter setup Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Options. Control Test Review Results Setup 09/16/2009 Setup Menu 3 F rom the Options menu screen, touch Beeper. 09:15 am Screen Options ID Setup Lockouts 09/16/2009 Options 09:15 am Sort The current setting is shown with white type on a black background.
Meter setup Auto off You can set up your CoaguChek XS Plus meter so that it turns itself off automatically if it has not been used (no buttons pressed or tests run) for a period of time you select. Use this feature to save power and extend the life of the batteries. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup. Patient Test 2 F rom the Setup menu screen, touch Options. Control Test Review Results Setup 09/16/2009 Setup Menu 3 F rom the Options menu screen, touch Auto Off.
Meter setup Computer Your CoaguChek XS Plus meter can connect with a computer via an infrared interface using optional base unit. Using a computer, you can set up operator or patient lists, for example, or you can transfer test results stored in the meter to a PC for further evaluation. Using this computer capability requires software. The COMPUTER screen prompt option allows you to activate or deactivate the meter’s ability to communicate with a computer.
Meter setup ID Setup Use the ID Setup screen to enter settings for user management and patient management. These settings are optional; the meter can be operated without these settings. There are three types of identification used with the CoaguChek XS Plus meter: n The System Administrator, who has special rights to enter certain meter settings (provided the administrator has been set up), and is the only one who can enter and change these settings.
Meter setup System Administrator (Admin.) In the default setting, the meter is not protected with an Admin. password, and all setup options are accessible to anyone. If you set up a Admin. password, the following setup areas are automatically reserved only for the Admin: n Screen: Units, Date/Time n Options: (connection to a) computer n ID Setup (the entire area) n QC Lockout n Operator Lockout (only available with optional software) Please note: When you enter a Admin.
Meter setup ***| Admin. A B 09:15 am C D 0 1 2 3 4 5 6 7 8 9 F G H I J L M N O P Q R S T U V W X Y 123 Repeat ID ABC 09:15 am ***| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 123 09:15 am E K Z Admin. | 4 U sing the keypad displayed on the screen, enter the Admin. password of choice. The password should include up to 20 characters and/or symbols of choice.
Meter setup Main Menu 09:15 am Changing an existing Admin. password: Patient Test Control Test 1 F rom the main menu screen, touch Setup. Review Results Setup 09/16/2009 Setup Menu 2 F rom the Setup menu screen, touch ID Setup. 09:15 am Screen 3 U sing the keypad displayed on the screen, enter the valid Admin. password. Options ID Setup Lockouts 09/16/2009 ***| Admin. A B 09:15 am C D E F G H I J K L M N O P Q R S T U V W X Y Z T he ID Setup is displayed.
Meter setup Main Menu 09:15 am Deactivating an existing Admin. password: Patient Test Control Test 1 F rom the main menu screen, touch Setup. Review Results Setup Setup Menu 09/16/2009 2 F rom the Setup menu screen, touch ID Setup. 09:15 am Screen 3 U sing the keypad displayed on the screen, enter the valid Admin. password. (OK). Touch Options ID Setup Lockouts 09/16/2009 ***| Admin.
Meter setup Operator (only available with optional software) To specify operators, an operator list must be created on the PC and downloaded into the meter using software. In the default setting, the meter is not set up for use with Operator ID numbers. You can enter settings to activate or deactivate the use of the operator list. Otherwise, the Operator screen prompt is not active (gray).
Meter setup Patient In the default setting, input of Patient ID is “optional.” This means a Patient ID can be entered for each test, but this isn’t required. If you don’t enter a Patient ID , the test is simply assigned a consecutive number (the same as when the Patient ID is deactivated). However, you can require that a Patient ID be entered. To set up a patient list, it must be created on the PC and downloaded into the meter using software. Main Menu 09:15 am 1 F rom the main menu screen, touch Setup.
Meter setup Patient ID 09:15 am Alphanumeric 6 S elect the input format of the Patient ID to be entered. Numeric You may select from the following options: Max. Length: 09/16/2009 20 n Alphanumeric (text and numbers, e.g., “J. Doe 3378”) n Numeric (numbers only, e.g., “3387”) n Max. Length: Indicate the maximum number of characters (1 … 20) the Patient ID can have. 7 T ouch the screen prompt with the format of choice for the Patient ID. Your selection is now displayed with a black background.
Meter setup Lockouts setup Note: The Lockouts menu contains the options for liquid quality control that require the operator to perform a liquid quality control test at specified intervals. If the liquid quality control test is not performed correctly, or if the result is outside the target value range, the meter is locked out from further use. The lockouts also can be set up selectively for individual operators.
Meter setup Operator lockout (only available with optional software) To perform a test with the CoaguChek XS Plus meter, the individual steps must be performed properly. Optional liquid quality control can be performed on a regular basis to ensure proper performance of these steps. The operator lockout prescribes regular liquid quality controls of this type for each operator (who has been set up). Main Menu 09:15 am 1 F rom the main menu screen, touch Setup.
Meter setup Op. Lockout 09:15 am No Weekly Monthly Every 3 Months 6 T ouch the screen prompt to select the interval of choice. Your selection is now displayed with a black background. Every 6 Months 09/16/2009 Op. Lockout Number of Levels One Level Two Levels 09/16/2009 50 5 T ouch or to display the option of choice on the screen. If the arrow is just an outline , this means the button is not active.
Meter setup QC (Quality control) lockout QC Lockout ensures that the optional liquid quality control tests are run on a regular basis for the meter to be used. This is independent of the operator, however. Use this option if you work without operator lists. It is also possible to mandate Operator (OP) Lockout and QC Lockout in parallel.
Meter setup QC Lockout Number of Levels One Level Two Levels 09/16/2009 09:15 am 5 T ouch the screen prompt with your option of choice for changing the test strip lot. 6 T ouch the screen prompt to select the interval of choice. Your selection is now displayed with a black background. 7 W hen you have selected the option of your choice, touch (OK) to save, or touch (Cancel) to cancel this procedure.
Testing a capillary blood sample Testing a capillary blood sample Gather what you need: n CoaguChek XS Plus meter n CoaguChek XS PT Test Strips and matching code chip n CoaguChek Lancet n CoaguChek Capillary tube/bulb (optional) Do not use glass capillary tubes or capillary tubes that contain anticoagulants. n Cotton ball and alcohol wipe Important notes Always … n … close the container immediately after having removed a test strip.
Testing a capillary blood sample Getting a good capillary blood sample To get a suitable drop of blood: n Warm the hand. Have the patient hold it under his or her arm, use a hand warmer, or wash with warm water. n Have the patient let that arm hang down by his or her side before lancing a finger. n Massage the finger from its base. Use these techniques until the fingertip has increased color.
Testing a capillary blood sample Preparing to test 1 Have the test strip container at hand. 2 M ake sure that the code chip supplied with these test strips is at hand.
Testing a capillary blood sample Test strip code chip The test strip code chip provides the meter with important information that it needs to perform the coagulation test. The chip contains information about the test method, the lot number and the expiration date. The test strip code chip is required when a new test strip container is opened to store the lot information about the test strips in the meter. Your CoaguChek XS Plus meter stores the data from up to 60 code chips that were inserted.
Testing a capillary blood sample 2 A lways make sure that the number on the code chip matches the number on the label of the test strip container. 3 S lide the new code chip into the code chip slot (as shown) until you feel it snap into place. Always compare the code number you see on the display with the number that is printed on the test strip container you are using. If the two code numbers don’t match, insert the correct code chip in the slot in the meter.
Testing a capillary blood sample Switching on the meter 1 P lace the meter on a level, vibrationfree surface, or hold it in your hand so it is roughly horizontal. Turn the meter on by pressing the On/Off button and holding until the meter turns on. Alternatively, you can insert a test strip or connect it to the power adapter to turn it on. The next steps depend on whether you work with or without operator lists.
Testing a capillary blood sample With operator list (only available with optional software) Operator 09:15 am 3 I f an operator list exists, wait until this list is displayed. Alan Smithee Jane Brown 4 S elect the operator of choice by touching the screen prompt for it. Touch or to scroll to the language of choice on the screen. If the arrow is just an outline , this means the arrow is not active.
Testing a capillary blood sample Performing a test Main Menu 09:15 am Patient Test Control Test Review Results Setup 09/16/2009 Main Menu 09:15 am QC Lockout Control Test 8 C heck the battery level. If there are no bars left in the battery symbol, you cannot perform any more tests. 9 C heck that the date and time are correct. Correct any wrong entries as described in the chapter entitled Meter setup/Setting the date.
Testing a capillary blood sample Without patient list 10 Touch Patient Test. Patient ID | 09:15 am A B C D E F G H I J K L M N O P Q R S T U V W X Y , 123 Z Scan 11 If the Patient ID option was chosen as either optional or required when the meter was set up (see Meter Setup, ID Setup), you are prompted to enter a Patient ID. I f required, enter the Patient ID, then (OK) to move to the next press screen.
Testing the capillary blood sample With patient list (only available with optional software) 12 Touch Patient Test. Test 09:15 am PID01 Smith, Henry Patient ID | 09:15 am A B C D F G H I J K L M N O PID04 Miller, Ted P Q R S T PID05 Reed, William U V W X Y , 123 PID02 Jones, Walther PID03 Hamilton, Fran New 09/16/2009 Scan Z Scan E 13 Select the patient to be tested from the list that is displayed. Touch or to display the entry of your choice.
Testing a capillary blood sample 15 The test strip symbol prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. 16 Hold the test strip so the lettering “CoaguChek XS PT” is facing upward. 17 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.
Testing a capillary blood sample Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 The hourglass symbol shows that the test strip is warming up. When the warmingup process is complete, a further beep tone (provided the beeper is turned on) indicates that you can now apply blood.
Testing a capillary blood sample 18 Now lance the side of a fingertip with the lancing device. We recommend obtaining the capillary blood from the side of the fingertip, as this causes the least pain. Massage the lanced finger until a drop of blood is formed. Do not press or squeeze the finger. Apply the first drop of blood from the finger. 19 Apply the blood directly from the finger to the semicircular, transparent sample application area of the test strip.
Testing the capillary blood sample Alternatively... n …you can touch the blood drop against the side of the sample application area. The test strip draws up the blood by capillary action. uring this process, you must hold D the blood drop to the test strip until the flashing blood drop icon has disappeared and the meter beeps (provided the beeper is turned on). n … you can also apply the blood using the CoaguChek capillary tube.
Testing a capillary blood sample Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 QC The meter performs an automatic quality control test on the test strip before it displays the test result. “QC” appears in the display. Following a successful outcome of the quality control test, a check mark appears after “QC”. 09/16/2009 Test 09:15 am P-ID: PID01 Smith, Henry Op: Operator 1 Par: PT Code: 184 09/16/2009 09:14 am 2.5INR Comm.
Testing a capillary blood sample In this display, you can scroll through additional results or return to the main menu. Menu symbol: Return to main menu. Individual symbol: Scroll through older values stored for this patient. (This feature is active only if older values are present.) Remove 09:15 am 20 After the test and results are displayed, a Remove menu will appear on the screen. Remove the test strip from the measurement chamber. 21 Turn the meter OFF.
Quality control Quality control The CoaguChek XS Plus System has a number of built-in quality-control functions. n A check of the electronic components and functions every time the meter is turned on. n A check of the test strip temperature while a test is in progress. n A check of the expiration date and lot information on the test strip carried out by the code chip. n A two-level, on-board quality control test and patient result determination within a single test chamber.
Quality control Preparing to run a liquid quality control test Prepare for a liquid quality control test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of control solution instead of blood. 1 Have the test strip container at hand. 2 If you are using the test strip lot for the first time, make sure that the test strip code chip that came with these test strips is at hand.
Quality control 7 Close the container again. 8 M ake sure the dropper is at hand for the next steps in the liquid quality control test. 9 S wirl the bottle using a circular motion to completely dissolve all of the control plasma inside. Do not shake the bottle or turn it on its side. Doing so can cause components in the control plasma to stick to the sides of the bottle. T he control solution is now ready to be applied to the test strip.
Quality control Performing a liquid quality control test 10 Place the meter on a level, vibrationfree surface, or hold it in your hand so it is roughly horizontal. Turn the meter on by pressing the ON/OFF button . 11 Alternatively, you can insert a test strip or connect the meter to the power adapter to turn it on. Main Menu 09:15 am Patient Test Control Test Review Results Setup 09/16/2009 72 12 Wait until the main menu is displayed, and log on. 13 Check the battery level.
Quality control Main Menu 09:15 am 15 Touch Control Test. QC Lockout Control Test Review Results Setup Logout 09/16/2009 QC Test Operator 1 09:15 am 16 The test strip symbol prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. 17 Hold the test strip so the lettering “CoaguChek XS PT” is facing upward. 09/16/2009 18 Slide the test strip into the test strip guide in the direction indicated by the arrows.
Quality control QC Test Op: 09:15 am Operator 1 184 09/16/2009 If you are using a new control solution, remove the code chip from the meter and insert the code chip that came with the control solution instead. QC Test * If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. As with the test strips, a quality control code chip is also provided with the liquid quality controls.
Quality control QC Test QC: 999 Code: 184 Par: Op: Operator 1 09:15 am PT 20 Select the level for this measurement. Level 1 Level 2 09/16/2009 QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 The hourglass symbol shows that the test strip is warming up. When the warmingup process is complete, a further beep tone (provided the beeper is turned on) indicates that you can now apply control solution.
Quality control 21 Using the dropper, draw up the dissolved contents of the vial. 22 Apply a single drop of control solution directly from the dropper to the semicircular, transparent sample application area of the test strip. Do not add more control.
Quality control QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 You hear a beep tone when you have applied enough control solution (provided the beeper is turned on). The dropper symbol disappears and the test starts. 09/16/2009 QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 09/16/2009 09:15 am 1.2 INR (1.0 - 1.4 INR) The result of the liquid quality control test is displayed. It is automatically saved to memory.
Quality control QC Test 09:15 am QC: 999 Level: 1 Code: 184 Par: PT Op: Operator 1 If a liquid quality control test fails, an up arrow (too high) or down arrow (too low) is displayed and flashes. 09/16/2009 09:15 am 0.9 INR (1.0 - 1.4 INR) Comm. 09/16/2009 In this display, you can scroll through additional results or return to the main menu. Menu symbol: Return to main menu Scroll symbol: Scroll through older values stored in memory. (This feature is active only if older values are present.
Review Results Review Results The CoaguChek XS Plus meter has a 1,000-value memory for saving results (patient tests and/ or liquid quality control tests) together with time and date. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved. In addition, the meter stores up to 60 code chip records (contents of test strip code chips and control solution code chips).
Review Results Memory 09:15 am 4 S elect the function you want to perform in the memory.
Review Results Display Patient Result memory Memory 09:15 am This memory area contains all test results for your patients, sorted chronologically or by Patient ID. The most recent results are at the top of the list. PID01 09/15/2009 11:31 am PID01 09/14/2009 10:10 am PID01 09/13/2009 10:07 am PID01 09/12/2009 10:01 am PID01 09/11/2009 10:03 am 1 Touch or to display the entry of choice on the screen.
Review Results Display QC (Quality Control) memory Memory 09:15 am PID01 09/15/2009 11:31 am PID01 09/14/2009 10:10 am PID01 09/13/2009 10:07 am This memory area contains all liquid quality control tests that were run, sorted chronologically. The most recent results are at the top of the list. PID01 09/12/2009 10:01 am PID01 09/11/2009 10:03 am 1 Touch or to display the entry of choice on the screen. 09/16/2009 2 Touch the entry you want to open.
Cleaning Cleaning/Disinfecting It is important to follow the procedures below to clean and disinfect the meter. Failure to follow these procedures may cause malfunction of the meter. n Do not use sprays of any sort. n Ensure that swab or cloth is only damp, not wet.
Cleaning Cleaning/Disinfecting the Test Strip Guide n Use only 70% isopropyl alcohol or 10% bleach solution to clean/disinfect the CoaguChek Plus test strip guide. n Do not use any other cleaning/disinfecting solutions on the test strip guide. Use of other cleaning/disinfecting solutions could result in damage to the meter. 1 Open the cover With the meter powered off, use your thumbnail to open the cover of the test strip guide by pressing its front edge upward.
Cleaning 3 Allow to dry With the cover off, allow the test strip guide to dry for about 10 minutes. 4 Close the cover Close the cover, and make sure it snaps into place.
Error messages Error messages Depending on the circumstances, an error message may appear on the display of your meter. Error messages can have up to three warning levels as indicated by the following symbols and their meanings. Reports a warning message Reports an error (see: Error messages) Reports a serious error (see: Error messages) Error messages users might see during normal testing are included, but not limited to, the examples on the following pages.
Error messages Error message (always prefaced by Error) Brief description Error Test strip guide cover open Error Code chip error Error Test strip beyond expiration date Error Test strip unusable Error Allowed time for blood application exceeded Error Blood application error JVKL EXP 4 ? Error Measurement error 6 87
Error messages Error message (always prefaced by Error) Error QC Brief description Quality control: Test strip unusable or quality control for new lot missing Error Measurement error Error Diagnostic testing error Error Diagnostic testing error Error Internal memory error (patient) Error Internal memory error (QC) Error Internal memory error (setup) 7 8 9 Patient QC 88
Error messages Error message (always prefaced by Error) Brief description Error Data transfer error Error Control solution beyond expiration date Error Memory (almost) full Error Date/time inconsistent Error ID error EXP ? DD:MM:YY 89
Error messages Troubleshooting error messages after turning the meter on Error Description/Solution Error: Test strip A test strip was already inserted when the meter was turned on with the ON/OFF button. Error Solution Remove the test strip. The error message disappears. The meter is ready. Error: Ambient temperature Error The meter is too cold or too warm to measure correctly.
Error messages Troubleshooting error messages when preparing to test Error Error: Cover Error Description/Solution The test strip guide cover is not properly closed. Solution Close the test strip guide cover. The error message disappears. The meter is ready. Error: Test strip Error The test strip is unusable or the test strip is not a CoaguChek XS PT test strip. Solution Remove the test strip and repeat the test with a new or appropriate test strip.
Error messages Troubleshooting error messages during or after blood application Error Description/Solution Error: Time for application The maximum allowed time of 180 seconds for applying blood has been exceeded. exceeded Error Solution Turn the meter off, remove the test strip and start a new test using the same test strip and blood taken from a new fingerstick from a different finger.
Error messages Error Error: Quality Control Description/Solution This message appears if quality control lockout was set up for new code lockout. A quality control test must be carried out when a new test strip lot is used. The quality control for new lot is missing. Solution Error QC Perform a quality control test with the new test strip lot. Error: Measurement Measurement error resulting from the blood sample Error 7 Solution Turn the meter off and remove the test strip.
Error messages Troubleshooting other error messages Error Error: Diagnostic test Error Description/Solution Error during the internal diagnostic test which the meter performs. Solution Turn the meter off and remove the batteries. Wait at least one minute before re-inserting the batteries in the battery compartment, and then set the date and time. 8 Repeat the test. If the error message persists, the meter has a fault. Please call Roche Diagnostics Technical Service Center at 1-800-428-4674.
Error messages Error Error: Memory test (setup) Error Description/Solution The memory contains faulty data. Solution The meter has a fault. Please call Roche Diagnostics Technical Service Center at 1-800-428-4674. Error: Data transfer Error Data was transferred incorrectly. Solution Repeat the last action. Error: Quality Control Error EXP The control solution is beyond the expiration date. Solution Use a new control solution with the code chip belonging to it.
Error messages Error Error: Date/time setting Error ? Description/Solution Date/time is inconsistent Solution Check date/time. DD:MM:YY Error: Password Error The entered operator or supervisor password is wrong. Solution Enter the correct password.
Further information Further information Ordering Please contact Roche Diagnostics Customer Service at 1-800-428-5076.
Further information Preamble The licenses for most software are designed to take away your freedom to share and change it. By contrast, the GNU General Public License is intended to guarantee your freedom to share and change free software—to make sure the software is free for all its users. This General Public License applies to most of the Free Software Foundation’s software and to any other program whose authors commit to using it.
Further information translated into another language. (Hereinafter, translation is included without limitation in the term “modification”.) Each licensee is addressed as “you”. Activities other than copying, distribution and modification are not covered by this License; they are outside its scope. The act of running the Program is not restricted, and the output from the Program is covered only if its contents constitute a work based on the Program (independent of having been made by running the Program).
Further information this section to claim rights or contest your rights to work written entirely by you; rather, the intent is to exercise the right to control the distribution of derivative or collective works based on the Program. In addition, mere aggregation of another work not based on the Program with the Program (or with a work based on the Program) on a volume of a storage or distribution medium does not bring the other work under the scope of this License. 3.
Further information 5. You are not required to accept this License, since you have not signed it. However, nothing else grants you permission to modify or distribute the Program or its derivative works. These actions are prohibited by law if you do not accept this License.
Further information 9. The Free Software Foundation may publish revised and/or new versions of the General Public License from time to time. Such new versions will be similar in spirit to the present version, but may differ in detail to address new problems or concerns. Each version is given a distinguishing version number.
Further information How to Apply These Terms to Your New Programs If you develop a new program, and you want it to be of the greatest possible use to the public, the best way to achieve this is to make it free software which everyone can redistribute and change under these terms. To do so, attach the following notices to the program.
Further information This software was developed by the Computer Systems Engineering group at Lawrence Berkeley Laboratory under DARPA contract BG 91-66 and contributed to Berkeley. All advertising materials mentioning features or use of this software must display the following acknowledgement: This product includes software developed by the University of California, Lawrence Berkeley Laboratory.
Product specifications Product specifications Operating conditions and technical data Temperature range 59°F to 90°F (15°C to 32°C) Relative humidity 10% to 85% (no condensation) Maximum altitude 14,000 feet (4300 m) Position Place the meter on a level, vibration-free surface or hold it so it is roughly horizontal. Measuring range %Q: 120 - 5 SEC: 9.6 - 96 INR: 0.8 - 8.
Product specifications Sample material Sample type Capillary whole blood or non-anticoagulated venous whole blood.
Warranty Warranty CoaguChek XS Plus Meter Limited (1 Year) Warranty ROCHE DIAGNOSTICS warrants, to the original purchaser only, that the meter shall be free from all defects in material and workmanship for a period of one year from the date of purchase. Purchaser’s sole and exclusive remedy, with respect to the CoaguChek XS Plus meter and parts thereof, shall be the repair and/or replacement of the meter or parts at the option of Roche Diagnostics.
0123 Manufactured for: Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www.coaguchek.com 0 5021464001 (02) 2009-11 USA COAGUCHEK is a trademark of Roche.
