Roche CoaguChek XS System for Patient Self Testing User Guide

Roche CoaguChek XS System for Patient Self Testing

Product Information

The CoaguChek XS System is a portable device used for measuring blood clotting time in patients who are taking anticoagulant medication. The system includes the CoaguChek XS Meter, test strips, and a lancet device. The meter uses a small sample of blood obtained from a fingertip to provide an accurate reading of the patient’s INR (International Normalized Ratio) value. The meter is designed for patient self-testing and is intended to be used under the guidance of a healthcare professional.

Product Usage Instructions

Getting Started for Patient Self-Testing

To get started using the CoaguChek XS Meter:

1. Watch the CoaguChek XS System Training DVD to get familiar with the meter and testing procedure.
2. Read the CoaguChek XS Softclix lancet device package insert.
3. Follow the steps in the CoaguChek XS System Getting Started guide to perform your first test.

If necessary, refer to the CoaguChek XS System User Manual or package insert for more information.

Installing Batteries & Setup

1. Open the battery compartment on the back of the meter.
2. Insert 4 AAA alkaline batteries according to the diagram inside the battery compartment.
3. To set the date and time:
   • Start setup.
   • Set the date, time, and format using the buttons on the meter.
   • Check the display to ensure the settings are correct.
   • Power the meter off.
4. If the meter is not already in Setup mode, press the Setup button.

Preparing for a Test

1. Gather the necessary items.
2. Match the code number on the test strip container with the code chip.
3. Insert the code chip into the code chip slot on the meter.
4. Prepare the lancet device by inserting a new white lancet and twisting off the protective cap.

Testing

1. Wash your hands in warm, soapy water and thoroughly dry your fingertip.
2. Turn on the meter and ensure all symbols and numbers appear correctly on the display.
3. Obtain a small sample of blood using the lancet device and apply it to the test strip.
4. Wait for the meter to provide a reading of your INR value.
5. Power off the meter and dispose of the used lancet and test strip properly.

GETTING STARTED

Follow these steps to get started using the meter:

1. Watch the CoaguChek XS System Training DVD. It will help you get comfortable with the CoaguChek XS Meter and the testing procedure.
2. Read the CoaguChek XS Softclix lancet device package insert.
3. With this CoaguChek XS System Getting Started guide by the meter, follow the steps to perform your first test. Then, as necessary, refer to the User Manual or Package Insert: The CoaguChek XS System User Manual for Patient Self-Testing is a comprehensive guide to the meter and test strips. It is designed to provide answers to your questions about the meter’s operation and use. Also, see the test strip package insert for more information.

Installing Batteries & Setup

1. Open Compartment
   • Open the battery compartment on the back of the meter.
2. Insert Batteries
   • Insert 4 AAA alkaline batteries according to the diagram inside the battery compartment.
   • Right after you insert the batteries, set the date and time.
   • The date and time settings are important. Each time you run a test, the meter compares its date with the test strip’s expiration date. If the test strip is expired, the meter displays an error message and prevents you from running a test.
   • Whenever you put batteries in the meter, it automatically goes to Setup mode (where you set the date and time). You can also go to Setup mode at any time by pressing the SET button ( ). When you turn the meter on, the display briefly shows the installed software version in the upper left corner of the display.

setting Date & Time

1. Start Setup
   • To set the date and time, use these buttons: to change a setting and (SET) to accept a setting.
   • If the meter is not already in Setup mode, press . The date format flashes in the upper right corner. change the format, if required.
2. Set Date
   • Press. The year flashes. to change the year then to change the month then . to change the day then.
   • The time format flashes in the upper left corner. to change the format, if required.
   • If the date and time settings have not been set correctly, the meter may not detect that an expired test strip or an expired code chip is used.
3. Set Time
   • Press. The hour flashes. to change the hour then. to change the minutes then.
   • Power the meter off.
   • Only for software version 5.40 and lower: Ensure with the next test result that the measuring unit is displayed as INR. If the result is displayed in %Q or Sec, follow the instructions in the User Manual to reset the measuring unit to INR.
4. Check Display
   • Press and hold the ON-OFF button
   • Make sure all the letters, numbers, and symbols on the display appear correctly.
   • Review The Meter’s Display section in the User Manual to review the full display.
   • Release
   • Power the meter off

Preparing for a Test

1. Gather Items
   • CoaguChek XS Meter
   • Container of test strips
   • Test strip code chip
   • CoaguChek XS Softclix lancet device and white lancet
2. Match Code
   • The code number on the test strip container and the code chip must match.
   • Each box of test strips comes with a matching code chip.
   • Every time you open a new box of test strips, you must replace the code chip.
3. Insert Code Chip
   • Make sure the meter is off.
   • With the code number facing up, insert the code chip into the code chip slot until it snaps into place.
   • Using the wrong code chip can produce inaccurate results.
4. Prepare Lancet Device
   • Pull the cap off the lancet device. Insert a new white lancet. Twist off the lancet’s protective cap.
   • Put the cap back on the lancet device. Line up the notches for the cap to fit.

Testing

• Before continuing, review these tips for getting a good drop of blood.
• Increasing the blood flow in your finger will help you get a good drop of blood:
• Warm your hand. Hold it under your arm, use a hand warmer, and/or wash with warm water.
• Let your arm hang by your side.
•  Massage your finger from its base.
• Use these techniques until your fingertip has good color.

1. Wash Hands
   • Wash your hands in warm, soapy water.
   • Make sure your fingertip is thoroughly dry.
2. Get Ready
   • Take a test strip out of the container.
   • Close the container tightly.
   • Note: You have 10 minutes to use a test strip once you remove it from the container.
3. Insert Test Strip
   • Slide the test strip into the test strip guide in the direction of the arrows until it stops.
   • The meter powers on.
   • The code number of the inserted code chip flashes on the display.
4. Match Code
   • Confirm that the number displayed matches the number on the test strip container, then press.
   • If the numbers are different, first make sure that the correct code chip is inserted. If the numbers still don’t match, call the Roche Customer Support Center at 1-800-428-4674.
   • An hourglass appears as the meter warms up. When the meter is warmed up, a flashing test strip and blood drop appear and the meter begins a countdown.
5. Collect Sample
   • Set the penetration depth to 5.
   • Press the plunger. A yellow dot appears in the release button.
   • Massage your finger until you see increased color in your fingertip.
   • Keeping your hand down, press the tip of the lancet device firmly against the side of your fingertip. Press the release button.
6. Get a Good Blood Drop
   • Gently massage your finger from its base until a drop of blood is formed. Do not press or squeeze the finger.
   • After sticking your fingertip, you have 15 seconds to apply the blood to the top or side of the clear target area of the test strip.
7. Apply Sample Until Meter Beeps
   • Find the target area on the test strip. You can dose from the side or top. See the User Manual for more information.
   • It’s important to hold the blood drop to the test strip until you hear a beep.
   • The hourglass appears when the blood test begins. Then, pull your finger away from the test strip.
   • Remember to apply only one drop of blood—don’t add more. Do not touch or remove the test strip when a test is in progress.
   • The result appears in about 1 minute.
8. Check the Result
   • Confirm that the measuring unit next to the result is displayed in INR.
   • Only for software versions 5.40 and lower:
   • You must confirm that the measured result is displayed in INR prior to using the result and whenever the date and time settings were modified unless your doctor has instructed you to measure in a unit other than INR (i.e. %Q or Sec).
   • If the result is displayed in %Q or Sec, follow the instructions in the User Manual to reset the measuring unit to INR, or call the Roche Customer Support Center at 1-800-428-4674.
9. Record Result
   • Record the INR result on the CoaguChek XS System Prothrombin Time Self-Testing Log Book.
   • Call your doctor and/or the service provider that provides your test strips and the handling of your test results.
   • Note: If during testing the meter displays an error message, refer to the Error Messages section of the User Manual for what to do next.
10. Clean Up
    • Remove the lancet from the lancet device. Place the used test strip and lancet in a puncture-proof container with a lid.
    • Press The meter powers off.
    • If the meter is dirty, wipe it clean with a lint-free tissue and an approved cleaning solution. Note: See Cleaning the Meter in the User Manual for more information.

• If you have questions,
• call Roche Customer Support Center at 1-800-428-4674, Monday through Friday from 7 AM to 11 PM EST.
• In case of an emergency, please contact your physician.
• COAGUCHEK and SOFTCLIX  are trademarks of Roche.
• ©2007-2022, Roche Diagnostics.
• All rights reserved.
• Roche Diagnostics GmbH
• Sandhofer Strasse 116
• 68305 Mannheim, Germany
• Made in Germany
• Manufactured for and distributed in the USA by: Roche Diagnostics
• 9115 Hague Road
• Indianapolis, IN 46256
• Rx Onlyhttps://go.roche.com/CoaguChekXS-USAdialog.roche.com
• 0 4999037001 (08) 2022-05 USA

Documents / Resources

| Roche CoaguChek XS System for Patient Self Testing [pdf] User Guide
CoaguChek XS System for Patient Self Testing, CoaguChek XS System, Patient Self Testing
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References

• navify® Portal
• CoaguChek® XS system

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