Roche Diagnostics Limited
CoaguChek Coagulation Meters
CoaguChek XS Plus System Operators Manual Ver 9.0 June 2018
Operators Manual
160 Pages
Preview
Page 1
CoaguChek® XS Plus System
Operator’s Manual
This is a CLIA-waived system.
CoaguChek XS Plus System ®
Operator’s Manual
0 5021464001 (09) 2018-06 USA
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 the property of their respective owners. © 2007-2018, Roche Diagnostics. US Order Number: 0 5021464001 (09) 2018-06 USA This document is available electronically at www.coaguchek-usa.com
4
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
5
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. Manual version
Revision date
Changes
05021464001 (01)
June 2009
New document
05021464001 (02)
November 2009
Revised for new firmware, claims changes, and new cleaning recommendations
05021464001 (03)
May 2010
Revised for CLIA waiver
05021464001 (04)
August 2010
Revised for CLIA waiver re submission
05021464001 (05)
May 2012
Revised for new firmware and minor revisions
05021464001 (06)
January 2013
Revised for CLIA waiver granted
05021464001 (07)
April 2016
Revised for additional test strip material number.
05021464001 (08)
June 2017
Revised to remove discontinued CoaguChek Lancet; added safety information on battery packs; minor editorial revisions, in line with OM V6 INT (05549043001 [05]).
05021464001 (09)
June 2018
Revised for information on cleaning/ disinfecting agents; added Status and Error Messages to Troubleshooting section. Updated branding.
6
7
1
Introduction 11 Before you start... 11 Intended use ... 11 CLIA Waived... 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 Electromagnetic Interference ... 19 Touchscreen... 19 Operating conditions ... 20 Quality control ... 20
2
The CoaguChek XS Plus Meter 21 Overview of the meter elements... 22 Buttons and icons overview ... 23 Power supply... 25
3
Putting the Meter into Operation 27 Inserting the batteries ... 28 Powering the meter on and off ... 29 Checking the software version ... 30
4
Meter Setup 31 Note on presentation of screen elements in this manual... 31 Settings summary ... 32 Screen setup ... 36 Contrast ... 36 Result Units ... 37 Result Confirmation... 39 Language Selection... 40 Setting the date... 41 Setting the time... 43 Setting the display options for date and time ... 45 Options setup ... 47 Sort ... 47 Beeper ... 49 Auto Off ... 52 Connection ... 54
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
8
ID setup... 56 System Administrator (Admin.)... 58 Operator ID ... 64 Patient ID ... 65 QC Settings setup ... 68 QC Range ... 69 QC (quality control) Lockout... 72 Operator Lockout ... 74 5
Testing a Blood Sample 77 Important notes... 77 Getting a good capillary blood sample ... 79 Getting a good result from venous whole blood... 79 Preparing to test ... 80 Test strip code chip ... 81 Inserting the code chip ... 81 Powering on the meter... 83 Performing a test ... 86 Accepting or rejecting a test result ... 94 Adding comments... 95
6
Control Testing and Quality Control 97 Preparing to run a liquid quality control test ... 98 Performing a liquid quality control test... 100
7
Review Results 109 Viewing test results ... 110 Display patient result memory... 112 Display QC (quality control) result memory ... 113
8
Extended Functionalities 115 Data handling ... 115 Computer (Setup option)... 115 Operator lists... 116 Patient lists... 117 Patient list validation ... 118 Stored test results and comments ... 119
9
Maintenance and Care 121 Conditions for storage and shipping ... 121 Storage ... 121 Shipping... 121 Cleaning and disinfecting the meter... 122 Acceptable cleaning/disinfecting agents... 122 Cleaning the exterior (meter housing) ... 123 Cleaning the test strip guide and test strip guide cover ... 124 Disinfecting the exterior (meter housing)... 126 Disinfecting the test strip guide and test strip guide cover... 127
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
9
10
Troubleshooting 129 Status and Error Messages ... 130 Additional information on Error 403... 133 Additional information on Error 406... 134 Errors and unusual behavior without error messages ... 135
11
General Product Specifications 137 Technical data ... 137 Sample material ... 137 Storage and transport conditions ... 138 Further Information ... 138 Ordering ... 138 Reagents and solutions ... 138 Product limitations... 138 Repairs ... 138 Information about software licenses ... 139
12
Warranty
13
Appendix 147 Contact Roche ... 147
14
Supplement for Observed Test Sequence 149 Observed Test Sequence (OTS) ... 149 Using the OTS function... 150 Index
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
146
153
10
This page intentionally left blank.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
11
1
Introduction
Before you start Intended use The CoaguChek® XS Plus is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood. CLIA Waived This is a CLIA Waived test system. A Certificate of CLIA Waiver (or higher) is required to perform the test. Information on obtaining CLIA certificates can be found at www.cms.hhs.gov/clia. Before testing, refer to the appropriate package insert for more complete information. Laboratories with a certificate of waiver must follow the manufacturer’s instructions for performing the test. 42 CFR 493.15(e)(1). Any modifications and/or failure to follow test system instructions, including those for limitations/ intended use and performance of QC testing as a failure alert mechanism, results in use that is considered high complexity and subject to all applicable CLIA requirements. All applicable state and local laws must be met. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting program online (at www.fda.gov/MedWatch/report.htm), by phone (1-800-FDA-1088), or by returning the postagepaid FDA form 3500 (which may be downloaded from www.fda.gov/MedWatch/getforms.htm) by mail to (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787) or fax (1-800-FDA-1078). If there are any problems with the CoaguChek XS Plus meter, notify CMS at http:// www.cms.hhs.gov/clia/ro-map.asp Important information regarding use
You must configure the CoaguChek XS Plus 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. 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.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
Introduction • 1
Read this operator's manual, as well as the package inserts for all relevant consumables, before using the system for the first time.
12
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 Plus 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 Plus 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 Plus 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 Plus meter displays test results in units equivalent to laboratory plasma measurements. Results may be displayed in three ways: ■
International Normalized Ratio (INR)
■
combination of INR/seconds, or
■
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.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
13
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 Plus meter has the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche (available separately). The CoaguChek XS Plus 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, 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.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
14
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 Plus 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.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
15
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.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
16
Safety Information Operator qualification Only trained healthcare professionals may operate the CoaguChek XS Plus system. Operators must have received comprehensive instruction in the operation, quality control, and care of the CoaguChek XS Plus system.
WARNING
Protection against infection and blood-borne pathogens Healthcare professionals using the CoaguChek XS Plus 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 Plus 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.
■
Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test.
■
Use an auto-disabling single-use lancing device for each patient.
■
Dispose of used lancets in a sturdy sharps container with lid.
■
Dispose of used test strips according to your institution’s infection control policy.
■
Follow all health and safety regulations in force locally.
Avoidance of electrical shock, fire, and explosions WARNING
■
Only use Roche Diagnostics 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.
■
Do not use loose power sockets or damaged power supply units, cables, plugs, or battery packs.
■
Do not short circuit the power supply unit, the handheld base unit contacts, or the battery pack.
■
Do not drop the CoaguChek XS Plus meter, the power supply unit, or the battery pack and protect these against shaking and vibrations.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
17
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 Do not dispose of the batteries with normal domestic waste. Dispose of used batteries in an environmentally responsible manner and in accordance with applicable local regulations and directives. Contact your local council/local authority or the manufacturer of the used batteries for advice on correct disposal.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
18
WARNING
Possible hazards posed by the battery pack Damaged or swollen lithium-ion (Li-ion) battery packs can overheat, catch fire, or leak. Immediately cease use of CoaguChek XS Plus 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 meters onto a fire. Do not dismantle, compress, or pierce the battery pack as this could cause an internal short circuit that leads to overheating.
■
Do not place either the battery pack or the CoaguChek XS Plus 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 handheld base unit. Keep this in mind when positioning the handheld base unit. Battery fluid or materials leaking from damaged battery packs can irritate your skin or cause burns due to high temperatures.
■
■
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. Extreme temperatures reduce the charging capacity and usage period of the meter and the battery pack.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
19
General Care NOTICE
Clean the meter only with the solutions recommended (see page 121). 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.
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.
■
Avoid prolonged exposure to direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the display.
Introduction • 1
NOTICE
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
20
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).
■
Only use the meter at a relative humidity between 10% and 85% (no condensation).
■
When operating the meter using the power adapter, use only a voltage of 100 V to 240 V (± 10%) , 50/60 Hz.
■
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.
■
A check of the test strip temperature while a test is in progress.
■
A check of the expiration date and lot information on the test strip based on the code chip data.
■
A two-level, onboard quality control test and patient result determination within a single test chamber.
Roche Diagnostics has available optional liquid quality controls for the CoaguChek XS Plus system. These controls are provided to assist with meeting regulatory compliance requirements as applicable to your facility.
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
21
2
The CoaguChek XS Plus Meter A
B
C
E F
The CoaguChek XS Plus Meter • 2
D
G
H
I
J
CoaguChek XS Plus Operator’s Manual, version 9.0 USA
K