® CoaguChek XS System User Manual This is a CLIA waived system.
Table of Contents About this Manual .............................................................................................1 Symbols and Abbreviations ...........................................................................1 User Resources ...................................................................................................2 Video.......................................................................................................................2 Getting Started ....................
About this Manual Memory .................................................................................................................30 Storing Test Results in Memory ................................................................30 Reviewing Stored Test Results...................................................................30 Erasing Stored Test Results ........................................................................32 Cleaning the Meter ....................................................
User Resources Several resources are available to help you use and maintain the CoaguChek XS System. Video (DVD Format) The CoaguChek XS System Video is for new users of the CoaguChek XS System. The video will help you get comfortable with the CoaguChek XS Meter and the testing procedure. Getting Started The Getting Started guide shows you how to perform your first coagulation test on the CoaguChek XS Meter.
How the System Works The CoaguChek XS System includes a meter and CoaguChek XS PT test strips. Each box of test strips has its own code chip that you insert into the meter. The code chip contains important information about the test strips such as their expiration date and lot number. The meter and test strips work together to provide a safe and reliable system for testing blood-clotting time. The CoaguChek XS System makes measuring blood-clotting time easy.
Getting Started Operating Conditions To ensure that the CoaguChek XS Meter functions correctly, follow these guidelines: • Use the meter at room temperature, between 65°F and 90°F (18°C and 32°C). • Use the meter at a relative humidity of less than 85%, without condensation. Refer to the Getting Started guide to learn how to set up the meter and prepare for and run your first blood-clotting-time test. Batteries The CoaguChek XS Meter uses 4 AAA batteries.
Installing (or Replacing) Batteries Meter Setup Have ready 4 AAA batteries. 1. Open Battery Compartment With the meter turned off, turn it over. Press the latch gently inward and lift the cover. Remove the old batteries, if necessary. The CoaguChek XS Meter is preset with the U.S. date format (month-day-year) and U.S. time format (12-hour as opposed to 24-hour).
1. Go to Setup Mode If the meter is not already in Setup mode, press the SET button . The time format flashes in the upper-left corner. 3. Set Current Time Press the SET button . Press the M button to change the hour. Press the SET button . The date format flashes in the upper-right corner. Press the M button to change the minutes. Press the SET button . 2. Set Today’s Date Press the SET button . 4. Turn Off Turn the meter off . Press the M button to change the year. Press the SET button .
Code Chip 2. Match Codes Make sure that the threenumber code on the new test strip container matches the three-number code on the new code chip. 3. Insert New Code Chip Slide the new code chip into the code chip slot until it snaps into place. Each box of test strips comes with its own code chip. The code chip provides the meter with information such as the lot number and expiration date of the test strips. Before each test, make sure the correct code chip is in the meter.
Testing a Blood Sample Integrated Quality Controls The CoaguChek XS System has quality control functions integrated into the meter and test strips, so you never have to run quality control tests with liquid quality controls. The meter automatically runs its own quality control test as part of every blood test. When the quality control test runs, the letters QC flash on the meter’s display. When the quality control test completes, a checkmark (✓) appears following the letters QC.
Important Notes About Blood Testing Always • Operate the meter at temperatures between 65°F and 90°F (18°C and 32°C). Infection Control Follow appropriate infection control guidelines. • Use gloves. • Use a separate lancet for each person. • Refer to the test strip package insert for proper use and handling of test strips. • Dispose of used lancets and test strips in a stable container with a lid according to infection control guidelines. • Keep the test strip guide and meter clean.
Preparing for a Test 1. Gather Items 3. Insert Code Chip Make sure the meter is turned off. With the code number facing up, insert the code chip into the code chip slot until it snaps into place. 4. Wash Hands Have the patient wash his or her hands in warm, soapy water. Or, clean the fingertip with an alcohol wipe. Gather the following items: • CoaguChek XS Meter • Container of test strips • Test strip code chip • CoaguChek lancet Each box of test strips comes with a matching code chip.
3. Match the Code Performing a Test 1. Get Ready Take a test strip out of the container. If the numbers are different, make sure you are using the code chip that came with the test strips you are using. Close the container tightly. Do not open a vial of test strips or touch a test strip with wet hands or gloves. This may damage the test strips. An hourglass appears as the meter warms up, which takes about thirty seconds You have 10 minutes to use a test strip once you remove it from the container.
5. Identify the Target Area Find the target area on the test strip. 7. Record Result Record the result according to your facility’s guidelines. 8. Clean Up Place the used test strip and lancet in an approved container. Turn the meter off . You can dose the target area by bringing the patient’s finger to the top of the test strip or by bringing the meter to the patient’s finger so that the side of the test strip touches the blood drop. 6.
Optional Testing Methods Out of Range Values The CoaguChek XS PT test strips provide test results if the INR value is between 0.8 and 8.0. If the result falls outside of this range, the meter displays < (less than) 0.8 or > (greater than) 8.0. If the meter indicates an out-of-range value, refer to the test strip package insert and repeat the test. In rare cases, Error Message 7 can occur in patients with long coagulation times (> 8 INR).
2. Fill the Capillary Tube When the flashing test strip appears on the meter’s display, stick the fingertip. Then touch the capillary tube to the blood drop. Keep the tube level, and allow it to fill by capillary action. Fill the tube only halfway. Avoid getting air bubbles into the sample. Do not touch the hole at the top of the bulb. If blood gets into the bulb during sample collection, discard the bulb and repeat the test with a new test strip and fingerstick. 3. Dose the Test Strip 4.
Using Venous Blood You may use the CoaguChek XS Meter to test venous blood. Blood may be collected directly using a butterfly or a needle and syringe. Do not clean the syringe tip with alcohol or water prior to dosing the test strip. Use only a plastic syringe free of anticoagulant. Do not use glass. The syringe needle should be 23 gauge or larger. A 21 gauge or larger needle is recommended. 2. Dose the Test Strip Do not touch the test strip.
Memory Storing Test Results in Memory 2. View Most Recent Result The most recent test result appears. The letters mem indicate that you are viewing a result in memory. The time and date of the test also appear. If there are no results in memory, a 0 appears in the display’s top-right corner. 3. View Earlier Results To view earlier results, press the M button again . After you have viewed all the results in the memory, 3 dashes appear.
Erasing Stored Test Results 2. Confirm You can erase all of the test results that are stored in the meter’s memory. You cannot, however, erase individual test results. To erase all stored results: 1. Go to Erase mode. With the meter turned off, press and hold down the M button . While you are holding down the M button, press the ON-OFF button and then hold down both buttons for at least 5 seconds. Press the M button to confirm that you want to erase the entire memory.
Cleaning the Meter It is important to keep the meter clean. Clean the meter whenever it looks dirty or, if you prefer a regular schedule, clean the meter each time you open a new box of test strips. Cleaning the Test Strip Guide 1. Open the Cover With the meter turned off, use your thumbnail to open the cover of the test strip guide by pressing its front edge upward. Move the cover safely away from the meter. Then rinse the cover with water or wipe it clean. 2.
Advanced Features 3. Allow to Dry With the cover off, allow the test strip guide to dry for about 10 minutes. The CoaguChek XS Meter includes advanced features that you can set up as necessary. They are: • Changing the unit of measurement • Turning off the beep (With the beep turned on, the meter beeps when it detects a test strip, when it is ready for you to apply a sample, when it detects a sample, when the result is displayed, and when an error occurs—3 short beeps.
The Meter’s Display Setting Advanced Features You can access these settings by going to Setup mode. To go to Setup mode, press the SET button . The date format, flashing, will appear. Once you are in Setup mode, you’ll use these buttons: • • to change a setting to accept a setting (and move on to the next setting) When you turn the meter on, it briefly shows all the display’s letters, numbers, and symbols. Regularly check that all segments of each letter, number, and symbol appear.
Error Messages You may see the following error messages while using the CoaguChek XS Meter. If you see an error message, first try to correct the problem using the solution described below. If the problem persists, call Roche Diagnostics Technical Service Center at 1-800-428-4674, 24 hours a day, 7 days a week. Error: Test Strip A test strip was already inserted when the meter was turned on. If you did not remove the test strip after the last test, you will see this error.
Error: Test Strip Guide Cover The test strip guide cover is not properly closed. Solution: Close the test strip guide cover. Error: Test Strip Expired The test strip has expired. Solution: Check the meter’s date setting. If it is not correct, set the correct date. For more information, see the Meter Setup section of this manual. If the date is correct, turn the meter off and remove the code chip and the test strip. Then use the code chip and a test strip from a new box of test strips.
Error Messages You May See After You Apply Blood Error: Time Exceeded You did not apply blood to the test strip within 2 minutes after the blood drop symbol appeared. Error: Test Strip Interference The test strip was touched or removed during the test. Solution: Turn the meter off and remove the test strip. Repeat the test using the same test strip and blood taken from a new fingerstick from a different finger. Do not touch or remove the test strip when a test is in progress.
Error: Measurement Error Measurement error caused by the blood sample. Solution: Do not touch or remove the test strip when a test is in progress. Be sure to apply the blood drop to the test strip within 15 seconds of sticking the fingertip. In rare cases, Error Message 7 can occur in patients with long coagulation times (> 8 INR). If this error message appears again when the test is repeated, the result must be checked using another method.
Other Information Ordering Information for Health Care Professionals Please contact Roche Diagnostics Customer Service at 1-800-428-5076. Product Specifications Operating Conditions Temperature +65°F to +90°F (+18°C to +32°C) Relative humidity less than 85% (without condensation) REF/Cat. Number Maximum altitude 14,000 feet (4300 m) CoaguChek XS System (includes carrying case) 04837975001 Placement Operate the meter on a level, vibration-free surface or hold it so it is roughly horizontal.
Symbols Sample Material Sample type Capillary whole blood or non-anticoagulated venous whole blood. Sample size At least 10 µL Interference Refer to the test strip package insert. Non-Operating Storage and Transport Conditions Temperature range -13°F to +158°F (-25°C to +70°C) Relative humidity 10 to 85% (without condensation) The following table lists all of the display screen icons and their meaning.
Symbol Meaning Beep tone is turned on Beep tone is turned off Result is above the chosen therapeutic range (only with INR as unit) Result is below the chosen therapeutic range (only with INR as unit) • Results in the chosen unit • Error numbers Memory contains no results or no further results 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.
Warranty CoaguChek XS 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 meter and parts thereof, shall be the repair and/or replacement of the meter or parts at Roche Diagnostic’s option.
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 www.coaguchek.
