CoaguChek XS User Manual Ver 8.0 June 2017

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CoaguChek® XS System User Manual Version 8.0

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The contents of this manual, including all graphics and photographs, 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. However, Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development. Caution: Federal law restricts this device to sale by or on the order of a physician This manual was created by the Roche Diagnostics Engineering Operations department. Direct questions or concerns regarding the contents of this document to: Roche Diagnostics Engineering Operations Department 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457 USA ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche. All other trademarks are property of their respective owners. © 2011-2017, Roche Diagnostics. US Order Number: 0 4837991001 (08) 2017-06 USA Distribution in USA by: Roche Diagnostics, Indianapolis, IN This document is available electronically at www.coaguchek-usa.com Revisions to this document are provided by Roche Diagnostics when necessary. No part of this document may be reproduced in any form or by any means without prior written consent.

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Manual version

Revision date

Changes

Version 3.0

November 2009

New document

Version 4.0

March 2011

Revised to update meter pictures, remove patent information, add disposal information, and update product specifications section.

Version 5.0

September 2013

Revised ERROR 6 verbiage.

Version 6.0

February 2016

Revised for additional test strip material number

Version 7.0

August 2016

Added GTIN information and revised section “Out of Range Values”

Version 8.0

June 2017

Revised to add pictures of Accu-Chek Safe-T-Pro Plus lancing device; added information on display check; minor editorial revisions.

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Table of Head Contents Section About this Manual...1 Symbols and Abbreviations...1 User Resources...2 Video...2 Getting Started...2 User Manual...2 Test Strip Package Inserts...2 The CoaguChek XS System...3 Anticoagulation Medication...3 Blood-clotting Time...3 How the System Works...4 The CoaguChek XS Meter...5 Operating Conditions...6 Getting Started...7 Batteries...7 Installing (or Replacing) Batteries...8 Meter Setup...9 Setting the Date and Time...9 Code Chip... 12 Inserting a New Code Chip... 12 Integrated Quality Controls... 14 Testing a Blood Sample... 15 Tips for a Good Fingerstick... 15 Important Notes about Blood Testing... 16 Always... 16 Never... 16 Infection Control... 17 Preparing for a Test... 18 Performing a Test... 20 Out of Range Values... 24 Optional Testing Methods... 25 Using Capillary Tubes... 25 Using Venous Blood... 28

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Section Head Memory... 30 Storing Test Results in Memory... 30 Reviewing Stored Test Results... 30 Erasing Stored Test Results... 32 Cleaning the Meter... 34 Cleaning the Exterior... 34 Cleaning the Test Strip Guide... 35 Advanced Features... 37 Setting Advanced Features... 38 The Meter’s Display... 39 Error Messages... 40 Error Messages You May See After You Apply Blood... 44 Other Information... 48 Ordering Information for Health Care Professionals... 48 Product Limitations... 48 Product Specifications... 49 Support/Services... 50 Symbols... 51 Disposal of the Meter, Test Strips, Lancets, and Batteries... 54 Warranty... 55

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About Manual Sectionthis Head Symbols and Abbreviations The test strip insert, the label on the back of the meter, the User Manual, and other packaging material may contain the following symbols or abbreviations: Use by Batch code/Lot number In vitro diagnostic medical device Catalog number Consult instructions for use Caution, consult accompanying documents. Refer to safety-related notes in the manual accompanying this instrument Manufacturer Date of manufacture Temperature limitation (Store at) The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance with UL 61010A-1:02 and CAN/CSA-C22.2 No.61010-1-04). Rx Only

Caution: Federal law restricts this device to sale by or on the order of a physician Global Trade Item Number

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User Resources Section Head 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.

User Manual This CoaguChek XS System User Manual 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. Read this entire manual carefully, and refer to it as necessary.

Test Strip Package Inserts Be sure to read the test strip package insert for important updates and keep the insert from your current test strip package for future reference.

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The CoaguChek Section Head XS System The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood.

Anticoagulation Medication Anticoagulation medications, also known as blood thinners, are prescribed to avoid unwanted clots. Blood-clotting time must be monitored to ensure that a patient’s medication dosage is correct.

Blood-clotting Time The rate at which blood clots is measured in units called INR. It is very important for patients to stay within their target INR range. If the INR is too low, the risk of blood clots increases. If the INR is too high, the risk for internal bleeding increases. Everyone’s INR is different. The patient’s doctor determines the best INR range for the patient, depending on why the patient is taking anticoagulants and how the patient reacts to them. The doctor also determines how often the patient’s blood should be tested. The doctor needs to know the patient’s blood-clotting time in order to successfully treat the patient.

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Section Head 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. The display on the meter guides you through the testing process. With the code chip inserted in the meter, you simply insert a test strip and apply a blood sample. The meter displays the result in about a minute. The meter automatically stores the result in memory so that you can easily recall results. The CoaguChek XS PT test strip contains various ingredients. When a blood drop is applied, the meter starts the test and the blood mixes with the ingredients on the test strip. When the meter determines that the blood has clotted, it stops the measurement and calculates the result.

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Section Head The CoaguChek XS Meter A B C D E

Display M (Memory) Button ON-OFF Button Test Strip Guide Cover Test Strip Guide

F G H I

Battery Compartment Cover Code Chip Slot SET Button Data Port

A

F

B

G

C

D E

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Section Head Operating Conditions To ensure that the CoaguChek XS Meter functions correctly, follow these guidelines: • Use the meter at room temperature, between 59°F and 90°F (15°C and 32°C). • Use the meter at a relative humidity of less than 85%, without condensation. • When testing, keep the meter level. • If you store the meter for a period of time, remove the batteries. • Do not use the meter at an altitude higher than 14,000 feet (4,300 meters). • Do not use the meter near a strong magnetic field, such as a microwave oven, as this may interfere with the meter’s proper operation. Note: The CoaguChek XS Meter automatically shuts off after 3 minutes if no buttons have been pushed.

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Getting Section Started Head 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. The recommended batteries, alkaline-manganese batteries, should last for approximately 300 tests. When you power the meter on, the display briefly shows the battery symbol. The battery symbol is divided into 4 segments. With new, fresh batteries in the meter, the battery symbol shows all 4 segments. When only 1 segment appears, replace the batteries. When only 1 segment appears you can still access results stored in the meter’s memory. If you insert new batteries within 1 minute of removing the old batteries, the date and time settings will remain in memory. But if you do need to reset the date and time, refer to the Meter Setup section in this manual. The meter saves battery power by automatically powering off after 3 minutes, unless you press a button or insert a test strip. Even when the batteries are removed, the test results are saved in memory.

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Section Head Installing (or Replacing) Batteries Have ready 4 AAA batteries. 1. Open Battery Compartment

2. Insert New Batteries

3. Power Off

With the meter powered off, turn it over. Press the latch gently inward and lift the cover. Remove the old batteries, if necessary.

Position the batteries according to the diagram inside the battery compartment. Replace the cover. Turn the meter back over.

Power the meter off

.

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Section Head Meter Setup 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). Before you use the meter for the first time-or if there is no battery power for more than 1 minute-you’ll have to set the current date and time. In addition, the meter has certain advanced features that you can set up if you plan to use them. See the Advanced Features section in this manual to learn more about the advanced features and how to set them up.

Setting 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 strips are 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 To set the date and time, you’ll use these buttons: •

to change a setting.

•

to accept a setting.

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Section Head 1. Go to Setup Mode

If the meter is not already in Setup mode, press the SET . button

The date format flashes in the upper-right corner.

2. Set Today’s Date

Press the SET button

.

Press the M button to change the year. Press the SET button . Press the M button to change the month. Press the SET button . Press the M button to change the day. Press the SET button .

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Section Head 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 . to Press the M button change the minutes. Press the SET button .

4. Power Off

Power the meter off

.

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Section Head Code Chip 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. Each time you open a new box of test strips, replace the old code chip with the new one. Protect the code chip from moisture and also from equipment that produces magnetic fields, such as a microwave oven.

Inserting a New Code Chip Have the correct code chip ready. 1. Remove Old Code Chip

With the meter powered off, remove the old code chip and throw it away.

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Section Head 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.

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Section Head 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 (P) appears following the letters QC. Then the meter continues to run the blood test. If the quality control test fails, the meter displays the following error message. See the Error Messages section in this manual for an explanation of this (and other) error messages and what to do when they occur.

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