CoaguChek XS Pro System Operators Manual Ver 05 Nov 2018

CoaguChek XS Pro System ®

Operator’s Manual

0 5914639001 (05) 2018-11 USA

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. 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 ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche. All other trademarks are the property of their respective owners. © 2009-2018, Roche Diagnostics. US Order Number 05914639001 (05) 2018-11 USA This document is available electronically at www.coaguchek-usa.com

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On the packaging and on the identification plate of the instrument you may encounter the following symbols, shown here with their meaning: Caution, consult accompanying documents. Refer to safety-related notes in the instructions for use accompanying this product. Temperature limitation (Store at) Use by Manufacturer LOT

Batch code/ Lot number Catalog number Global Trade Item Number

IVD

In vitro diagnostic medical device Consult instructions for use 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.

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Revision History Manual version

Revision date

Changes

05548829001 (01)

2009-09

New document; international launch

05914639001 (01)

2010-04

Update cleaning/disinfection, minor revisions; US launch with document 0 5914639001 (01)

05914639001 (02)

2012-05

Update to software version 03.01, new functions, minor revisions

05914639001 (03)

2014-04

Added local area network (LAN) safety message, safety information on battery packs, information on barcode symbologies; updated information on “hidden” patient list and patient list validation (p. 121-122); minor revisions.

05914639001 (04)

2016-04

Revised for additional test strip material number.

05914639001 (05)

2018-11

Revised to remove discontinued CoaguChek Lancet; added safety information on battery packs; updated information on cleaning/ disinfecting agents; added Status and Error Messages to Troubleshooting section. Updated branding; minor editorial revisions; in line with OM V6 INT (05548829001 [05]).

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Introduction 11 Before you start... 11 Intended use ... 11 Important information regarding use ... 11 If you need help ... 12 General note... 12 What can the system do for you? ... 12 Test principle ... 13 Important safety instructions and additional information... 14 Safety Information... 16 Disposal of the System... 17 General Care ... 19 Laser Scanner... 19 Electromagnetic Interference ... 19 Touchscreen... 19 Local Area Network: protection from unauthorized access ... 20 Wired network connection ... 20 Operating conditions ... 21 Quality control ... 21

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The CoaguChek XS Pro Meter 22 Overview of the meter elements... 23 Buttons and icons overview ... 24 Power supply... 26

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Putting the Meter into Operation 28 Inserting the batteries ... 29 Powering the meter on and off ... 30 Checking the software version ... 31

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Meter Setup 33 Note on presentation of screen elements in this manual... 33 Settings summary ... 34 Screen setup ... 38 Contrast ... 38 Result Units ... 39 Result Confirmation... 41 Language Selection... 42 Setting the date... 43 Setting the time... 45 Setting the display options for date and time ... 47

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Options setup ... 49 Sort... 49 Beeper ... 51 Auto Off... 54 Connection... 56 ID setup... 58 System Administrator (Admin.)... 60 Operator ID ... 66 Patient ID ... 67 QC Settings setup ... 70 QC Range ... 71 QC (quality control) Lockout... 74 Operator Lockout ... 76 5

Testing a Blood Sample 79 Important notes... 79 Getting a good capillary blood sample ... 81 Getting a good result from venous whole blood... 81 Preparing to test ... 82 Test strip code chip ... 83 Inserting the code chip ... 83 Powering on the meter... 85 Performing a test ... 88 Accepting or rejecting a test result ... 97 Adding comments... 98

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Control Testing and Quality Control 101 Preparing to run a liquid quality control test ... 102 Performing a liquid quality control test... 104

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Review Results 113 Viewing test results ... 114 Display patient result memory... 116 Display QC (quality control) result memory ... 117

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Extended Functionalities 119 Data handling ... 119 Computer (Setup option)... 120 Operator lists... 120 Patient lists... 121 Patient list validation ... 122 Barcode scanner... 122 Stored test results and comments ... 123

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Maintenance and Care 125 Conditions for storage and shipping ... 125 Storage... 125 Shipping ... 125 Cleaning and disinfecting the meter ... 126 Acceptable cleaning/disinfecting agents ... 126 Cleaning the exterior (meter housing)... 127 Cleaning the test strip guide and test strip guide cover ... 128 Cleaning the scanner window... 129 Disinfecting the exterior (meter housing)... 130 Disinfecting the test strip guide and test strip guide cover... 131

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Troubleshooting 133 Status and Error Messages ... 134 Additional information on Error 403... 137 Additional information on Error 406... 138 Errors and unusual behavior without error messages ... 139

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General Product Specifications 141 Technical data ... 141 Sample material ... 141 Storage and transport conditions ... 142 Further Information ... 142 Ordering ... 142 Reagents and solutions ... 142 Product limitations... 142 Repairs ... 142 Working with barcodes... 143 Operator and patient ID barcode masks... 144 Example of barcode symbologies ... 145 Information about software licenses ... 147

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Warranty

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Appendix 154 Contact Roche... 154

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Supplement for Observed Test Sequence 155 Observed Test Sequence (OTS) ... 155 Using the OTS function... 156 Index

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Introduction

Before you start Intended use The CoaguChek® XS Pro system (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time (PT), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs). Important information regarding use Read this operator's manual, as well as the package inserts for all relevant consumables, before using the system for the first time. You must configure the CoaguChek XS Pro meter according to your needs before initial use. Refer to chapter 4 Meter Setup. Be sure to read the Important safety instructions and additional information section in this chapter before operating the system.

Introduction • 1

Before you use the meter for the first time (after you have first inserted the batteries), you must set the date and time correctly to allow you to perform measurements properly. Each time you replace the batteries you need to check (and, if necessary adjust) the date and time.

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If you need help Information about using the system, the screen menus, and performing a test can be found in this manual. When error messages appear on the screen, refer to chapter 10 Troubleshooting. For all questions about the CoaguChek XS Pro system that are not answered in this manual, contact your Roche representative or Roche Diagnostics Technical Service. In order to expedite troubleshooting, please have ready your CoaguChek XS Pro meter, its serial number, this manual, and all related consumables when you call. General note The data and information provided in this manual are current as of issue. Any substantial changes will be incorporated in the next edition. If there is any conflict of information, the package insert included with the CoaguChek XS PT Test strips shall prevail. What can the system do for you? The CoaguChek XS Pro system makes coagulation testing easy. You only need to insert the code chip, power the meter on, insert the test strip, and apply a small blood sample. The blood mixes with the reagents on the test strip, and the meter determines when the blood clots. The meter displays the results in about one minute. After the measurement, the meter automatically stores the test result, together with date/time and patient ID (and operator ID, if that option is enabled) to memory. The CoaguChek XS Pro meter displays test results in units equivalent to laboratory plasma measurements. Results may be displayed in three ways: ■

International Normalized Ratio (INR)

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combination of INR/seconds, or

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combination of INR/%Quick

INR is a standardized measurement of the rate at which blood clots. A low INR can indicate an increased risk of blood clots, while an elevated INR can indicate increased risk of bleeding.

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The meter guides you through the test, step by step, using icons and instructions on the display. Each box of test strips has its own code chip that you insert into the meter. This code chip contains lot-specific information about its test strips, such as the expiration date and calibration data. Optional liquid controls for the system are also available. The CoaguChek XS Pro meter has the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche (available separately). The CoaguChek XS Pro meter supports data exchange via the POCT1A standard. Data management systems may have the ability to expand the security features of the meter, such as enabling operator lockouts. Data management systems may also enable data transfer to an LIS or HIS. Refer to the manuals of the Handheld Base Unit and of your DMS for technical details. Test principle

Introduction • 1

The CoaguChek XS PT Test Strip contains a lyophilized reagent. 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. Depending on the time elapsed when it first appears, this signal is then converted by means of an algorithm into customary coagulation units (INR, %Quick, seconds) and the result is displayed.

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Important safety instructions and additional information This section explains how safety-related messages and information related to the proper handling of the system are presented in the CoaguChek XS Pro Operator’s Manual. Read these passages carefully.

The safety alert symbol alone (without a signal word) promotes awareness to hazards which are generic or directs the reader to related safety information.

These symbols and signal words are used for specific hazards:

WARNING

WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION

CAUTION Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.

NOTICE

NOTICE Indicates a hazardous situation which, if not avoided, may result in damage to the system.

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.

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Illustrations in this manual show two different kinds of hands:

Hand without glove

Hand with glove

Introduction • 1

A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations.

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Safety Information Operator qualification Only trained healthcare professionals may operate the CoaguChek XS Pro system. Operators must have received comprehensive instruction in the operation, quality control, and care of the CoaguChek XS Pro system.

WARNING

Protection against infection and blood-borne pathogens Healthcare professionals using the CoaguChek XS Pro system to perform tests must be aware that any object coming into contact with human blood is a potential source of infection. Operators need to adhere to Standard Precautions when handling or using the CoaguChek XS Pro system. All parts of this system should be considered potentially infectious and are capable of transmitting blood-borne pathogens between patients and between patients and healthcare professionals. ■

Use gloves. Wear a new pair of clean gloves for testing each patient.

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Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test.

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Use an auto-disabling single-use lancing device for each patient.

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Dispose of used lancets in a sturdy sharps container with lid.

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Dispose of used test strips according to your institution’s infection control policy.

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Follow all health and safety regulations in force locally.

Avoidance of electrical shock, fire, and explosions WARNING

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Only use Roche original accessories (cables, power supply units, battery packs, and spare parts). Third-party cables, power supply units, and battery packs can cause the battery pack to explode or the meter to become damaged.

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Do not use loose power sockets or damaged power supply units, cables, plugs, or battery packs.

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Do not short circuit the power supply unit, the handheld base unit contacts, or the battery pack.

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Do not drop the CoaguChek XS Pro meter, the power supply unit, or the battery pack and protect these against shaking and vibrations.

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Disposal of the System

WARNING

Any product coming in contact with blood is considered contaminated (potentially infectious).* During normal testing, any meter may come in contact with blood. Lancing devices may also be considered sharps. Disposal of sharps is regulated by law in many jurisdictions. The European Union has a requirement for improving waster management practices for certain electronic equipment, but meters fall outside the scope of the European Directive 2002/96/EC** This is not a requirement for the U.S.A.; however, Roche is committed to recycling and sustainability. Comply with any laws or ordinances relating to the disposal of sharps and/or contaminated products. Contact your local health department or other appropriate authorities for proper handling and disposal of used meters, used test strips, used lancets, and used batteries. Please consider the following points when disposing of your used testing materials:. Consider recycling of the meters and batteries at an appropriate facility. Be aware the meter is potentially hazardous electronics scrap (e-scrap) and should be disposed of accordingly. The batteries are potentially hazardous also and should be disposed of accordingly. Disinfect the meter before recycling or disposing. *29 CFR 1910.1030 - Bloodborne pathogens **Directive 2002/96/EC - Directive on waste electrical and electronic equipment (WEEE).

Introduction • 1

Disposal of used batteries and battery packs Do not dispose of the batteries and battery packs with normal domestic waste. Dispose of them in accordance with applicable local regulations and directives and your facility’s guidelines on the disposal of electronic waste equipment.

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WARNING

Possible hazards posed by the lithium-ion battery pack Damaged or swollen lithium-ion (Li-ion) battery packs can overheat, catch fire, or leak. Immediately cease use of CoaguChek XS Pro meters with damaged or swollen Li-ion battery packs. Under no circumstances recharge meters with damaged or swollen Li-ion battery packs by placing them in the Handheld Base Unit or connecting them to the power adapter. Overheating can cause the battery pack to catch fire or explode. ■

Never throw the battery pack or the meter onto a fire. Do not dismantle, compress, or pierce the battery pack as this could cause an internal short circuit that leads to overheating.

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Do not place either the battery pack or the CoaguChek XS Pro meter on or in heating appliances, such as a microwave, conventional oven, or radiator.

Avoid prolonged exposure to direct sunlight, e.g., when the meter is docked in the base unit. Keep this in mind when positioning the base unit. Battery fluid or materials leaking from damaged battery packs can irritate your skin or cause burns due to high temperatures.

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Avoid contact with leaking battery fluid. In the event of accidental contact with the skin, rinse with water. If you get battery fluid in your eye(s), you should also seek medical attention. Handle and dispose of battery packs with care.

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Extreme temperatures reduce the charging capacity and usage period of the meter and the battery pack. The battery pack begins charging as soon as the power adapter is connected or the meter is placed on an active Handheld Base Unit (i.e., one connected to a power supply). NOTICE

Use only the specially designed battery pack provided by Roche Diagnostics. Using any other type of battery may damage the system.

Save or download data from the meter prior to replacing the battery pack to prevent loss of data (see Chapter 8). When storing or disposing of the battery pack, use the manufacturer's original packaging.

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General Care NOTICE

Clean the meter only with the solutions recommended (see page 126). Using other solutions may result in incorrect operation and possible system failure. Do not let cleaning solution enter the instrument. Make sure that the meter is thoroughly dried after cleaning or disinfecting.

Laser Scanner The built-in barcode scanner emits a laser beam when activated. The built-in barcode scanner is a Class 1 laser, according to EN 60825-1:2007.

WARNING

A barcode does not need to be present for the laser scanner to become active. Do not stare directly into the laser beam.

Electromagnetic Interference Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter.

Touchscreen ■

Use only your finger (even when wearing gloves) or special pens designed for use with touchscreens to touch the screen elements. Using pointed or sharp-edged objects can damage the touchscreen.

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Avoid prolonged exposure to direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the display. Introduction • 1

NOTICE

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Local Area Network: protection from unauthorized access If this product is connected to a local area network, this network must be protected against unauthorized access. In particular, it must not be linked directly to any other network or the Internet. Customers are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. This protection might include measures, such as a firewall, to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code. Wired network connection If the Handheld Base Unit from Roche is used to connect this meter to a local area network, the Handheld Base Unit must be protected against unauthorized access by means of a strong password management. Observe your own facility guidelines on password management where available, or apply the following rules:

Characteristics of strong passwords ■

Passwords must not contain the user’s account name or parts of the user’s full name that exceed two consecutive characters.

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Passwords must be at least eight characters in length.

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Passwords must contain characters from at least three of the following four categories: –

English uppercase alphabetic characters (A through Z)

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English lowercase alphabetic characters (a through z)

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Numeric characters (0 through 9)

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Non-alphabetic characters (for example, !, $, #, %)

Examples of weak passwords ■

uhxwze11 contains no upper case letter.

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UHXW13SF contains no lower case letter.

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uxxxxx7F contains the same character more than four times.

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x12useridF contains a substring of the user ID longer than four characters.

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Operating conditions To ensure that the meter functions properly, please observe the following guidelines: ■

Only use the meter at a room temperature between 15 °C and 32 °C (59 °F and 90 °F).

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Only use the meter at a relative humidity between 10% and 85% (no condensation).

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When operating the meter using the power adapter, use only a voltage of 100 V to 240 V (± 10%) , 50/60 Hz.

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When testing, place the meter on a level, vibration-free surface, or hold it so it is roughly horizontal.

Quality control The meter has a number of built-in quality-control functions: ■

A check of the electronic components and functions every time the meter is powered on.

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A check of the test strip temperature while a test is in progress.

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A check of the expiration date and lot information on the test strip based on the code chip data.

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A two-level, onboard quality control test and patient result determination within a single test chamber.

Introduction • 1

Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Pro system. These controls are provided to assist with meeting regulatory compliance requirements as applicable to your facility.

CoaguChek XS Pro Operator’s Manual, version 5.0 USA