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InstallationInstructions | Users Manual | 99.58 KiB | December 12 2013 | |||
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UserManual | Users Manual | 4.92 MiB | / January 03 2016 | |||
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UserManual EN | Users Manual | 5.29 MiB | May 11 2015 | |||
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UserManual FR | Users Manual | 4.95 MiB | / January 03 2016 | |||
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ExternalPhotos | External Photos | 478.38 KiB | / January 03 2016 | |||
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Label HBM4 | ID Label/Location Info | 141.18 KiB | December 12 2013 | |||
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1 2 3 4 | Test Setup Photos | / January 03 2016 | ||||||
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CoverLetter Authorization | Cover Letter(s) | 60.95 KiB | May 11 2015 / June 11 2015 | |||
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CoverLetter ConfidentialityRequestLetter | Cover Letter(s) | 193.70 KiB | May 11 2015 / June 11 2015 | |||
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CoverLetter ShortTermConf | Cover Letter(s) | 179.72 KiB | May 11 2015 / June 11 2015 | |||
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ModularApprovalRequestLetter | Cover Letter(s) | 248.84 KiB | December 12 2013 | |||
1 2 3 4 | Test Report | December 12 2013 | ||||||
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1 2 3 4 | InstallationInstructions | Users Manual | 99.58 KiB | December 12 2013 |
r Handheld Base Module Version 4 (HBM4) User / Instruction Manual General information for installing Warning for unauthorized modifications Device specific distinctions FCC and IC compliance (english) FCC and IC compliance (french) Installation guideline The radio transmitter equipped Handheld Base Module Version 4 (HBM4) can be installed in different end-use devices (hostreferred to as a host, host product, or host device) by manufacturer (Roche Diagnostics GmbH, Germany). A host product is required to comply with all applicable FCC equipment authorizations regulations, requirements and equipment functions not associated with the transmitter module portion. To ensure compliance with all non-transmitter functions, the host manufacturer is responsible for ensuring compliance witg the module(s) installed and fully operational. Changes or modifications made to the equipment not expressivly approved by Roche Diagnostics may void the FCC / IC authorization to operate this equipment. The module will be used in 2 different configurations, to meet the arrangement of device specific cable connections for further components (digital display, button and parameter specific measurement modules). The conducting paths are identical for each configuration, but the mechanical ports are getting installed device specific. This will ensure, that the WLAN functionality will not be affected due to different configurations. This device complies with Part 15 of the FCC Rules and with Industry Canada licence-exempt RSS standards. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation. Le prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes:
(1) l'appareil ne doit pas produire de brouillage, et
(2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. OEM integrator must ensure that the end user manual may not contain any information about the way to install or remove the module from the final product. The use of the transceiver module is authorized in mobile and stationary host devices taking into account the following conditions:
V1.3 The use of the transceiver module is authorized in mobile and stationary host devices taking into account the following conditions:
Label Information User Manual Additional authorization requirements for the non-
transmitter functions of the transmitter equipped HBM4 Module due to the intended use (IVD device) are required. The OEM integrator is responsible for ensuring that the after the moduile is installed and operational, the host continues to be compliant with the Part 15B unintentional radiator requirements. The information on the label and in the user manual is required to be incorporated in the manual of the final host device,. see 47 CFR15 requirements for more details (e.g. 15.19 / 15.21 / 15.101 / 15.105 / RSS-GEN
/ ICES) The inforamtion on the label and in the user manual is required to be incorporated in the manual of the final host device,. see 47 CFR15 requirements for more details (e.g. 15.19 / 15.21 / 15.101 / 15.105 / RSS-GEN
/ ICES) Additional label with the words 'Contains FCC ID:
VO9UU18' and 'Contains IC:3100A-UU18' shall be applied and visible from the outside of the host device The module must be installed and used in strict accordance with the manufacturer's instructions as described in the user documentation that comes with the module. The end user manual for the final host device operating with this transmitter must include operating instructions to satisfy RF exposure compliance requirements Radiofrequency radiation exposure Information General information Integrated antenna This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance of 20 cm between the radiator and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. The radiated output power of the device is far below the FCC radio frequency exposure limits. Nevertheless, the device shall be used in such a manner that the potential for human contact during normal operation is minimized. The antenna of the module may not be removed, replaced nor modified. The antenna must not be co-
located or operating in conjunction with any other antenna or transmitter. No additional antenna must be used When the final host product operating with this transmitter deviate from above, installation of this module into specific final hosts may require the submission of a Class II permissive change application containing data pertinent to RF Exposure, spurious emissions, ERP/EIRP, and host/module authentication, or new application if appropriate. Standard Data Rates Modulation IEEE 802.11b IEEE 802.11b IEEE 802.11g 802.11b/g 1, 2, 5.5 and 11 Mbps DSSS/CCK OFDM V1.3 Transmit Power Output (max.) IEEE 802.11b Receive Sensitivity IEEE 802.11b IEEE 802.11b Maximum Receive Level Transmit Power Output (max.) IEEE 802.11g Receive Sensitivity IEEE 802.11g IEEE 802.11g Maximum Receive Level Intended transmission output power tolerance Certifications of used WiFi-Chip EMC/Immunity 12 dBm 1 Mbps, 8% PER 2 Mbps, 8% PER 5.5 Mbps, 8% PER 11 Mbps, 8% PER PER<8%
7 dBm 6 Mbps, 10% PER 9 Mbps, 10% PER 12 Mbps, 10% PER 18 Mbps, 10% PER 24 Mbps, 10% PER 36 Mbps, 10% PER 48 Mbps, 10% PER 54 Mbps, 10% PER PER<10%
2dB United States: FCC Part 15 Canada: Industry Canada European Union: CE Mark V1.3
1 2 3 4 | UserManual | Users Manual | 4.92 MiB | / January 03 2016 |
CoaguChek Pro II Operators Manual Revision History Manual version Version 1.0 Version 2.0 Revision date 2015-11 2015-11 Changes New document Revised safety information on barcode handling, minor changes CoaguChek Pro II Operators Manual Version 2.0 0 7154879001 (02) 2015-11 EN 2015 Roche Diagnostics GmbH. All rights reserved The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. 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. Please send questions or comments about this manual to your local Roche representative. ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche. All other trademarks are the property of their respective owners. The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance. 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 Batch code/ Lot number Catalog number In vitro diagnostic medical device LOT IVD This product fulfills the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices. 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). On meters with WLAN capability:
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada For other WLAN certifications, see label on bottom of battery compartment and addendum for information on WLAN registration. 5 This page intentionally left blank. 6 7 1 2 3 Introduction 11 1.1 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 Contents of the pack ...................................................................................................................... 14 1.2 Important safety instructions and additional information......................................................... 15 Safety information............................................................................................................................ 17 Disposal of the system ................................................................................................................... 18 General care....................................................................................................................................... 18 Battery pack ....................................................................................................................................... 18 Electromagnetic Interference ...................................................................................................... 21 Touchscreen....................................................................................................................................... 21 Local Area Network: protection from unauthorized access ............................................ 21 Wired network connection ........................................................................................................... 22 Wireless connectivity ...................................................................................................................... 23 Radiofrequency radiation exposure information.................................................................. 23 Operating conditions ...................................................................................................................... 27 Quality control ................................................................................................................................... 27 1.3 Overview of the meter elements ....................................................................................................... 28 1.4 Buttons and icons overview ................................................................................................................. 30 1.5 Power supply.............................................................................................................................................. 33 Putting the Meter into Operation 35 2.1 Installing or replacing the battery pack........................................................................................... 36 Removing the battery pack .......................................................................................................... 37 Installing the battery pack ............................................................................................................ 38 2.2 Powering the meter on and off........................................................................................................... 41 Checking the software version ................................................................................................... 41 Meter Setup 43 Note on presentation of screen elements in this manual................................................. 43 3.1 Settings summary ................................................................................................................................... 45 3.2 Screen setup.............................................................................................................................................. 49 Contrast ............................................................................................................................................... 49 Result Units ........................................................................................................................................ 50 Result Confirmation......................................................................................................................... 51 Language Selection......................................................................................................................... 52 Setting the date................................................................................................................................. 53 Setting the time................................................................................................................................. 55 Setting the display options for date and time ....................................................................... 56 8 3.3 Options setup ........................................................................................................................................... 58 Sort......................................................................................................................................................... 58 Beeper .................................................................................................................................................. 60 Auto Off................................................................................................................................................ 62 Connection.......................................................................................................................................... 63 QR Code............................................................................................................................................... 64 Computer............................................................................................................................................. 67 Printer ................................................................................................................................................... 68 Parameter Selection ........................................................................................................................ 69 3.4 ID Setup ....................................................................................................................................................... 70 System Administrator (Admin.)................................................................................................... 72 Operator ID ........................................................................................................................................ 76 Patient ID ............................................................................................................................................ 77 3.5 QC Settings setup .................................................................................................................................... 79 QC Range ............................................................................................................................................ 80 QC (quality control) Lockout........................................................................................................ 83 Operator Lockout ............................................................................................................................. 86 STAT Test Configuration................................................................................................................ 88 Scan QC Material ............................................................................................................................. 90 3.6 Diagnostics................................................................................................................................................. 91 4 Testing a Blood Sample 93 4.1 Important notes......................................................................................................................................... 93 Getting a good capillary blood sample .................................................................................... 95 Getting a good result from venous whole blood.................................................................. 96 4.2 Preparing to test ....................................................................................................................................... 97 Test strip code chip ......................................................................................................................... 97 Inserting the code chip .................................................................................................................. 98 Powering on the meter................................................................................................................... 99 4.3 Performing a test .................................................................................................................................. 102 Applying blood from the fingertip........................................................................................... 108 Applying blood with a syringe.................................................................................................. 109 Accepting or rejecting a test result........................................................................................ 112 Adding comments......................................................................................................................... 113 Displaying the test result as QR code ................................................................................... 114 Finishing the test ........................................................................................................................... 114 STAT tests ........................................................................................................................................ 115 5 Control and Proficiency Testing 117 5.1 Control testing........................................................................................................................................ 117 5.2 Preparing to perform a liquid quality control test..................................................................... 118 5.3 Performing a liquid quality control test......................................................................................... 120 5.4 Proficiency testing................................................................................................................................. 127 5.5 Preparing to perform a proficiency test........................................................................................ 128 5.6 Performing a proficiency test............................................................................................................ 129 9 6 7 8 9 10 Review Results (Memory) 133 6.1 Viewing test results .............................................................................................................................. 134 Display patient result memory ................................................................................................. 136 Display QC (quality control) result memory........................................................................ 137 Extended Functionalities 139 7.1 Data handling......................................................................................................................................... 139 Computer (Setup option) ........................................................................................................... 141 Operator lists................................................................................................................................... 142 Patient lists ...................................................................................................................................... 143 Patient list validation.................................................................................................................... 144 Configuring operator and patient IDs ................................................................................... 145 Barcode scanner ........................................................................................................................... 145 Stored test results and comments.......................................................................................... 145 Maintenance and Care 147 8.1 Conditions for storage and shipping ............................................................................................. 147 Storage.............................................................................................................................................. 147 Shipping............................................................................................................................................ 148 8.2 Cleaning and disinfecting the meter ............................................................................................. 149 Difference between cleaning and disinfecting.................................................................. 149 When should the meter be cleaned and disinfected? .................................................... 149 What to clean and disinfect?.................................................................................................... 149 8.3 Recommended cleaning/disinfecting agents............................................................................. 151 8.4 Cleaning/disinfecting the exterior (meter housing)................................................................. 152 8.5 Cleaning/disinfecting the test strip guide ................................................................................... 153 8.6 Cleaning the scanner window.......................................................................................................... 154 Troubleshooting 155 Additional information on error E-406 .................................................................................. 156 Errors and unusual behavior without error messages .................................................... 157 Meter reset ...................................................................................................................................... 158 General Product Specifications 159 10.1 Technical data ....................................................................................................................................... 159 Sample material ............................................................................................................................ 159 Storage conditions........................................................................................................................ 160 Transport conditions.................................................................................................................... 160 10.2 Further Information .............................................................................................................................. 161 Consumables / Accessories ..................................................................................................... 161 Reagents and solutions .............................................................................................................. 161 Product limitations........................................................................................................................ 161 Information about software licenses .................................................................................... 162 Repairs .............................................................................................................................................. 163 Contact Roche................................................................................................................................ 163 11 Warranty 164 10 A B C Appendix 165 A.1 Operator and patient ID barcode masks........................................................................................165 A.2 Example of barcode symbologies .....................................................................................................166 A.3 Supported characters in 2D barcodes ............................................................................................169 Appendix 171 B.1 Supplement for Observed Test Sequence .....................................................................................171 Observed Test Sequence (OTS) .............................................................................................. 171 Using the OTS function............................................................................................................... 172 Appendix 175 C.1 Option: Wireless network (WLAN)....................................................................................................175 Background..................................................................................................................................... 176 Technical implementation.......................................................................................................... 177 RF specific functionalities and effective performance claims...................................... 179 Index 183 1 Introduction 1.1 Before you start Intended use Important information regarding use The CoaguChek Pro II system (consisting of the CoaguChek Pro II meter and the CoaguChek family of test strips) is used for the determination of PT and aPTT by healthcare professionals in a Point of Care environment. 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 Pro II meter accord-
ing to your needs before initial use. Refer to chapter 3, 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 battery pack), you must set the date and time correctly to allow you to perform meas-
urements properly. Each time you replace the battery pack you need to check (and, if necessary adjust) the date and time. QC Lockout is disabled by default. For routine confirma-
tion of system reliability it is recommended to enable this feature. 11 1 n o i t c u d o r t n I 12 If you need help General note What can the system do for you?
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 9, Troubleshooting. For all questions about the CoaguChek Pro II system that are not answered in this manual, contact your Roche Diagnostics representative. In order to expedite trouble-
shooting, please have ready your CoaguChek Pro II meter, its serial number, this manual, and all related con-
sumables when you call. The data and information provided in this manual are current as of issue. Any substantial changes will be incor-
porated in the next edition. If there is any conflict of infor-
mation, the package insert included with the CoaguChek test strips shall prevail. The CoaguChek Pro II 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. Depending on which test parameter is selected, the meter displays the results after approximately one minute
(PT) or after several minutes (aPTT). 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 Pro II meter displays test results in units equivalent to laboratory plasma measurements. Results may be displayed in the following ways:
Parameter: aPTT seconds Parameter: PT 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. 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 cali-
bration data. Optional liquid controls for the system are also available. The CoaguChek Pro II meter has the ability to connect to a data management system (DMS) through the Handheld Base Unit from Roche Diagnostics (available separately) or via wireless communication (WLAN). The CoaguChek Pro II 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 ena-
bling operator lockouts. Data management systems may also enable data transfer from a HIS and/or to a LIS. Refer to the manuals of the Handheld Base Unit and of your DMS for technical details. The CoaguChek Tests contain desiccated reagents. These consist of activators, a peptide substrate, and non-
reactive components. When a sample is applied to a test strip, the reagent dissolves and the activators start the coagulation process, leading to the formation of the enzyme thrombin. Simultaneously the meter starts to measure the time. Thrombin cleaves the peptide sub-
strate, generating an electrochemical signal. Depending on the time elapsed when this signal first appears, it is converted via an algorithm into customary coagulation units (depending on the test, into INR, %Quick, or seconds) and the result is displayed. 13 1 n o i t c u d o r t n I Test principle 14 Contents of the pack The CoaguChek Pro II pack contains the following items:
CoaguChek Pro II meter Universal Battery Pack Power supply Operators Manual (printed version, not shown here) Manual CD ROM (contains PDF files of the Opera-
tors Manual in other languages, not shown here) Check for completeness and transport damage immedi-
ately after unpacking. 1.2 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 Pro II Operators 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 CAUTION NOTICE WARNING Indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE Indicates a hazardous situation which, if not avoided, may result in damage to the system. Important information that is not safety relevant is pre-
sented against a colored background (without a sym-
bol). Here you will find additional information on correct use of the meter or useful tips. 15 1 n o i t c u d o r t n I 16 Illustrations in this manual show two different kinds of hands:
Hand without glove Hand with glove A dashed arrow between screen illustrations indicates that some screens have been skipped in these illustrations. Safety information Operator qualification Only trained healthcare professionals may operate the CoaguChek Pro II system. Operators must have received comprehensive instruction in the operation, quality con-
trol, and care of the CoaguChek Pro II system. WARNING WARNING Protection against infection There is a potential risk of infection. Healthcare profes-
sionals using the CoaguChek Pro II system must be aware that any object coming into contact with human blood is a potential source of infection. Healthcare professionals must also be aware that any cross-con-
tamination is a potential source of infection for patients. Use gloves. Use an auto-disabling single-use lancing device for each patient. Dispose of used lancets and needles in a sturdy sharps container with lid. Dispose of used test strips according to your institu-
tions infection control policy. Follow all health and safety regulations in force locally. Avoidance of electrical shock, fire, and explosions 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 Pro II meter, the power supply unit, or the battery pack and protect these against shaking and vibrations. 17 1 n o i t c u d o r t n I 18 Disposal of the system WARNING General care NOTICE Infection by a potentially biohazardous instrument The CoaguChek Pro II system or its components must be treated as potentially biohazardous waste. Decontamina-
tion (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal. Dispose of the system or its components according to the appropriate local regulations. Always remove the battery pack before thermal disinfection. Clean the meter only with the solutions recommended
(see page 147). 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. Battery pack The meter contains a rechargeable battery pack that begins charging as soon as the power adapter is con-
nected 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. WARNING Possible hazards posed by the battery pack Damaged or swollen battery packs can overheat, catch fire, or leak. Immediately cease use of CoaguChek Pro II meters with damaged or swollen battery packs and under no circumstances recharge them (do not place in the Handheld Base Unit). 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 Pro II meter on or in heating appli-
ances, 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 Hand-
held 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. 19 1 n o i t c u d o r t n I 20 Observe the following general safety instructions for handling the battery pack:
Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facilitys guidelines on the disposal of electronic waste equipment. When storing or disposing of the battery pack, use the manufacturer's original packaging. Save or download data from the meter prior to replacing the battery pack to prevent loss of data (see Chapter 7). Always power the meter off before removing the battery pack. When the Battery Low warning is displayed, the meter must be returned as soon as possible to the Handheld Base Unit or connected to the power adapter for recharging. When the battery capacity is too low for further tests, the meter must be returned immediately to the Handheld Base Unit or connected to the power adapter for recharging. Electromagnetic Interference The meter fulfills the IEC 61326-2-6 requirements for emitted interference and interference immunity. Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter. Electrostatic discharges may cause malfunction of the meter. Touchscreen NOTICE 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 func-
tionality of the display. Local Area Network: protection from unauthorized access If this meter is connected to a local area network, this network must be protected against unauthor-
ized access. In particular, it must not be linked directly to any other network or the Internet. Cus-
tomers 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 sep-
arate the device from uncontrolled networks as well as measures that ensure that the connected net-
work is free of malicious code. If you use a customized data management system solution, ensure that sensitive data transmitted via the POCT1-A interface is protected by appropriate security measures. Ensure that the instrument is protected against unauthorized physical access and theft. Do not use shared user or operator accounts on meter, DMS and network. Whether working in a wired or wireless environ-
ment, use a strong password for user or operator accounts on the meter, DMS, and network. Observe your own facility guidelines on password manage-
ment where available, or apply the rules for strong passwords, see Characteristics of strong pass-
words below. 21 1 n o i t c u d o r t n I 22 Wired network connection If the Handheld Base Unit from Roche Diagnostics is used to connect this meter to a local area network, the Handheld Base Unit must be protected against unauthor-
ized access by means of a strong password manage-
ment. Observe your own facility guidelines on password management where available, or apply the following rules:
Characteristics of strong passwords Passwords should not contain the users account name or parts of the users full name that exceed two consecutive characters. Passwords should be at least eight characters in length. Passwords should contain characters from the following three categories:
English uppercase alphabetic characters
(A through Z) English lowercase alphabetic characters
(a through z) Numeric characters (0 through 9) Examples of weak passwords uhxwze11 contains no upper case letter. UHXW13SF contains no lower case letter. uxxxxx7F contains the same character more than four times. x12useridF contains a substring of the user ID longer than four characters. Wireless connectivity Radiofrequency radiation exposure information If the meter is equipped with WLAN functionality:
Wireless connectivity allows the meter to send data (test results, patient IDs, operator IDs, etc.) to the data man-
agement system without the need to return the meter to the Handheld Base Unit. This feature must be configured by the system administrator. Observe the guidelines of your facility for using wireless local area network connec-
tions. For a description of the CoaguChek Pro II meters ability to connect to Wireless Local Area Networks
(WLAN, Wi-Fi), see appendix C.1. Glossary:
FCC stands for Federal Communications Commission (USA). RF stands for radio frequency RSS stands for Radio Standards Specification
(Canada). WLAN stands for Wireless Local Area Network 23 1 n o i t c u d o r t n I 24 The Industrial, Scientific and Medical (ISM) radio frequencies may contain emissions from microwave ovens, heaters, and other noncommunication devices. While these types of devices usually pose no threat of interference as they are low-powered devices, the possi-
bility exists that some industrial high power systems may wipe out any attempted communication use of a WLAN. Therefore, perform a site survey and interference analysis with a spectrum analyzer to view the entire spectrum, looking for signals that might not only be within the fre-
quency range of the intended WLAN but also could be near or at the same frequency and cause interference. Roche Diagnostics supports industry wireless standards and recommends using products that have Wi-Fi certifica-
tion. This certification tests products to the 802.11 industry standards for basic connectivity, security, authentication, Quality of Service (QoS), interoperability and reliability. The Wi-Fi CERTIFIED logo is an assurance that the Wi-Fi Alli-
ance has tested a product in numerous configurations and with a diverse sampling of other devices to ensure compat-
ibility with other Wi-Fi CERTIFIED equipment that operates in the same frequency band. The Wi-Fi Alliance network of independent test labs conducts interoperability testing programs to ensure that wireless devices work together and support secure connections. The CoaguChek Pro II system complies with FCC radia-
tion exposure limits set forth for an uncontrolled environ-
ment. This equipment should be installed and operated with minimum distance of 20 cm (8 inches) between the radiator and your body. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment. This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired opera-
tion. 25 1 n o i t c u d o r t n I 26 The CoaguChek Pro II system complies with the emission and immunity requirements described in EN 61326-2-6. It has been designed and tested to CISPR 11 Class B. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interfer-
ence in a residential installation. This equipment gener-
ates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instruc-
tions, may cause harmful interference to radio communi-
cations. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by powering the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is con-
nected. Consult the dealer or an experienced radio/TV technician for help. This Class B digital apparatus complies with Canadian ICES-003. Operating conditions Quality control To ensure that the meter functions properly, please observe the following guidelines:
Only use the meter at a room temperature between 12 C and 32 C (54 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. The meter has a number of built-in quality-control functions:
A check of the electronic components and func-
tions 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. An onboard quality control within every single test strip. Roche Diagnostics offers liquid quality controls for the CoaguChek Pro II system. These controls are designed to assist you in meeting regulatory compliance require-
ments at your facility. 27 1 n o i t c u d o r t n I 28 1.3 Overview of the meter elements B A C D E F E G H I J A B C D E F G H I J Touchscreen Shows test results, information, icons, and results recalled from memory. To select an option, simply touch the button lightly. On/Off button Press this button to power the meter on or off. Test strip guide cover Remove this cover to clean the test strip guide (if it has become soiled, e.g., with blood). Test strip guide Insert the test strip here. Barcode scanner The integrated barcode scanner can scan operator, patient, and QC sample IDs into the meter. Battery compartment cover Remove to insert the battery pack. Charging terminals Used for power supply and/or charging the battery pack when the meter is docked in the (optional) Handheld Base Unit. Code chip slot (shown with code chip) Insert the code chip here. Connection socket for power adapter Plug in the power adapter here. Infrared interface
(Covered by the semi-transparent panel) Supports data communication. 29 1 n o i t c u d o r t n I 30 1.4 Buttons and icons overview The buttons and icons that appear during normal opera-
tion are shown here, along with their respective mean-
ings. Error messages and the description of the icons linked to them are provided in a separate chapter. See Troubleshooting starting on page 155. Button/Icon Meaning Go to Main Menu OK; save setting Cancel; discard setting Return (to previous menu) Decrease/increase the value displayed. Scroll through lists that are too long to be displayed all at once. Inactive button:
Value cannot be further decreased/increased or:
End of list in this direction is reached List of tests of a specific patient Print after test result or from memory Display test result as QR code Add a comment Operator must wait until the meter has completed an action Insert test strip Remove test strip Button/Icon Meaning Apply sample (the time left to apply sample is counted down in the display) Apply liquid control (QC) sample (the time left to apply sample is counted down in the display) Insert the test strip code chip QC Insert the QC code chip QC
%Q SEC INR Automatic quality control completed successfully Results are displayed as a Quick percentage value Results are displayed in seconds Results are displayed in INR units Result in the chosen unit of measure is above the measuring range. Result in the chosen unit of measure is below the measuring range. Quality control: Result is above the specified range Quality control: Result is below the specified range Battery status:
When the battery pack is fully charged, all segments are lit. Individual segments disappear one by one as the battery pack becomes weaker. in red. When there is only one segment remaining the icon is displayed When there is no segment remaining, you may not be able to finish performing a test. Recharge as soon as possible. Operation with power supply adapter am pm Time between midnight and noon (in 12-hour time format) Time between noon and midnight (in 12-hour time format) 31 1 n o i t c u d o r t n I 32 Button/Icon Meaning Room or meter temperature is outside the acceptable range The test strip guide cover is open Reports a status message (see: Chapter 9, Troubleshooting) Reports an error message or a warning (see: Chapter 9, Troubleshooting) QC!
Lockout, one or more parameters are locked The following icons may appear when using the meter in conjunction with a data management system (DMS). Button/Icon Meaning Communication is taking place via the infrared interface If displayed in the status bar: communication is taking place via If displayed on the Patient Test button: connectivity lockout, only WLAN STAT testing possible An OTS request is pending Cleaning/Disinfection necessary Patient test result is out of normal patient test range 1.5 Power supply The CoaguChek Pro II meter is operated with the rechargeable battery pack. Insert the battery pack even when using the power adapter. This ensures that you will not lose the date and time settings if the power goes out. The power adapter also serves as a charger for the battery pack. To save power, the CoaguChek Pro II meter has an auto-
matic power-off function (auto-off). The default setting is 5 minutes of inactivity (e.g., no screen touches). It is possible to customize the auto-off function via your Setup selection (refer to Auto Off on page 62). When the meter powers itself off, all results are automat-
ically saved to memory. 33 1 n o i t c u d o r t n I 34 Main Menu 09:15 am During battery operation, the meter always displays the battery power level. Patient Test Control Test Review Results Setup 05/29/2015 When replacing the battery pack, insert the new battery pack within 24 hours of removing the old one. Otherwise you may need to re-enter date and time. The meter retains results in memory even when no bat-
tery pack is inserted. All settings other than date and time are retained as well. Dispose of used battery packs in an environmentally responsible manner in accordance with applicable local regulations and directives. See Infection by a potentially biohazardous instrument on page 18. 2 Putting the Meter into Operation Before using the meter for the first time, perform the fol-
lowing steps:
1 2 3 4 Install the battery pack Connect the power adapter to charge the battery pack Set the current date and time Enter your chosen settings (language, unit of measure, user administration if applicable, etc.) 35 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 36 2.1 Installing or replacing the battery pack When shipped, the battery pack is not installed in the CoaguChek Pro II meter. Unused battery packs lose their charge over time and have to be recharged before they can be used. After installing a new battery pack, the meter should be charged for two hours before testing. Please note that the battery pack will only reach full capacity once it has been fully emptied and charged several times. Whenever the meter is placed on an active Handheld Base Unit or powered by the power adapter, the icon is displayed. This icon shows that power is availa-
ble and the meter can be charged if necessary. Make sure that the permitted temperature range for charging the battery pack (12-32 C or 54-90 F) is maintained during installation and initial setup. Removing the battery pack 1 2 If a battery pack is already installed, make sure that the meter is powered off. Place the meter face down on a level surface. 3 4 5 Using a an appropriate starshaped screwdriver, e.g. Torx size T5, remove the four screws holding the battery compartment cover in place. Remove the battery compartment cover from the meter. The battery pack now visible is connected to the meter by a plug. Carefully lift the battery pack and remove the plug connector. Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facilitys guidelines on the disposal of electronic waste equipment. 37 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 38 Installing the battery pack 1 Loosen the screws on the battery compartment cover until they are protruding about 4-5 mm (2/10 in). 2 Hold the battery pack in your hand, with the wires and the plug pinched between your thumb and index finger. 3 4 Plug the connector plug into the socket. Place the battery pack inside the battery compart-
ment as shown above. To position the battery pack correctly, always align the ridges on the side of the battery pack with the ridges on the inside of the battery compartment. 39 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 5 6 Place the cover on the battery compartment. Make sure that the plug connector wires do not get pinched between meter and cover the protrusion on the battery compartment cover fits into the corresponding groove on the battery compartment rim Tighten all four screws until snug (do not over-
tighten). 40 Date 09:15 am Year:
2015 Month:
Day:
5 Time 29 Hour:
05/29/2015 Minute:
9 59 09:15 am AM PM 05/29/2015 After inserting a new battery pack, the meter powers on automatically. The Roche logo is displayed. If the meter does not power on automatically, the battery pack may be empty. Connect the power adapter for a minimum of 30 minutes, then remove the plug and try to power the meter on. If it powers on, the battery pack is charging properly. Within a short period of time, the start screen should appear. If the meter has been without power for too long, it will show the date and time settings dialog and you have to re-enter the date and time settings. The screens for entering the date and the time appear. Enter the date and time. After you have entered the correct information, confirm each screen with
. After installing a new battery pack, the meter should be charged for two hours before testing. 7 2.2 Powering the meter on and off 1 2 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. Power the meter on by pressing the button. You can also power on the meter directly by inserting a test strip, connecting the power adapter, or by docking it in the Handheld Base Unit. 3 To power the meter off after use, press the button for approximately 1 second. Checking the software version Init CoaguChek 04.00.00 After displaying the Roche logo, the meter briefly displays the Init (for initialization) screen. Here you can check which software version is currently running on your meter. (The Init screen shown here is for illustration pur-
poses only. Version numbers on your meter may differ.) 41 2 n o i t a r e p O o t n i r e t e M e h t g n i t t u P 42 This page intentionally left blank. 3 Meter Setup Note on presentation of screen elements in this manual Buttons are screen prompts that cause something to happen when touched. The names of all buttons are either shown as bold text or as the icon used on the button (e.g., for OK). Other screen elements (e.g., Menu titles) are written in italics. These screen elements are not active. If you have not set the date and time (after powering on for the first time or because the battery pack was removed from the meter for more than 10 minutes), you cannot perform a test. In that case powering on the meter takes you immediately to the Setup mode, where you must set the date and time (see page 53 and fol-
lowing). After date and time have been set, the meter automati-
cally moves to the Main Menu, where you can start a test or enter more settings. You can open any displayed function by touching (or tap-
ping) the button for it with your finger (or a special pen for this purpose). Tap means: Touch the button, then remove your finger from the touchscreen. The next screen appears once you remove your finger. If the meter did not automatically enter the Setup mode
(e.g., after the battery pack was replaced), you can open the Setup Menu from the Main Menu. 43 3 p u t e S r e t e M 1 2 Touch Setup to open the meter settings. Select the relevant group of settings (see the Settings summary following this section.). 44 Main Menu 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 Setup Menu 09:15 am Screen Options ID Setup QC Settings Diagnostics 05/29/2015 45 3.1 Settings summary The diagram below shows all of the setup areas that can be accessed on the meter. Setup Screen Options ID Setup Contrast Result Con rmation Date / Time Result Units Language Selection Sort Auto Off Parameter Selection Beeper Connection Admin. Operator Patient QC Settings QC Range Lockouts Scan QC Material Diagnostics General Hardware Wireless Setup Software Memory Usage 3 p u t e S r e t e M 46 Group Screen Subgroup Contrast Result Units Setting Result Confirmation Language Selection Date/Time Date Time Date formats Time formats Values *
0 10 (5 *) INR *
INR/SEC INR/%Q Enable Disable *
Dansk Deutsch English *
Espaol Franais Italiano Nederlands Norsk Portugus Suomi Svenska 01/01/2015 *
12:00 am *
DD.MM.YYYY (01.01.2015) MM/DD/YYYY (01/01/2015) *
YYYY-MM-DD (2015-01-01) 24-hour time format (24h) 12-hour time format (12h), with am/pm *
* Default settings are labeled with an asterisk (*). Group Options Subgroup Sort Setting Beeper Beeper Auto Off Key Click
[minutes]
Connection QR Code Parameter Selection ID Setup Admin. (Administrator) Operator (Operator List is optional) Patient Values *
Date/Time *
Patient ID Patient Name Off Low Medium *
High Off *
On Off 1 (5*) 10 15 20 25 30 40 50 60 Off *
Computer Printer Off *
On Enable Disable *
Blank (Off) *
Inactive *
Active No *
Optional Required
* Default settings are labeled with an asterisk (*). 47 3 p u t e S r e t e M 48 Group QC Settings Subgroup QC Range Lockouts Diagnostics Scan QC Material General Software Hardware Memory Usage Wireless Setup Setting PT aPTT Operator Lockout
(only if the Operator option is set to Active and an operator list is available) QC Lockout Values *
Default Range*
Custom Range Off *
Weekly Monthly Every 3 months Every 6 months Yearly Number of levels New code (Yes/No) Scheduled No*
Daily Weekly Monthly STAT Test Config. Number of hours Number of strips For each option except No:
Number of levels (1/2) Enable Disable *
Quantity Optional *
Scan Only
* Default settings are labeled with an asterisk (*). 3.2 Screen setup Contrast The Screen setup area contains the options for changing the display. Use the Contrast menu to adjust the display to your ambi-
ent light conditions and make it easier to read. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. From the Screen menu, touch Contrast. If a button is grayed out, this means the function is not available. Contrast 09:15 am Contrast (0-10):
5 05/29/2015 4 5 to change the contrast in a range or Touch from 0 to 10. Contrast 0 makes the display very dark. Contrast 10 makes the display very light. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch 49 3 p u t e S r e t e M 50 Result Units Use this setting to select the unit(s) in which the result is displayed. This setting only applies to PT test results. Regardless of the settings chosen for PT, aPTT is always displayed in seconds. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. From the Screen menu, touch Result Units. 2 3 The current unit of measure setting is highlighted (white type on a blue background). You can select either:
4 5 INR INR and seconds INR and Quick value in %
Touch the button to select the unit of measure of choice. Your selection is now highlighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch Patient Test Control Test Review Results Setup 05/29/2015 Units 09:15 am INR INR/SEC INR/%Q 05/29/2015 Result Confirmation In some circumstances, it may be useful for operators to confirm the validity of their results. Use this setting to prompt operators to confirm the results of every test. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. From the Screen menu, touch Result Confirmation. Touch Enable or Disable. Your selection is now highlighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch Result Con rmation 09:15 am Enable Disable 05/29/2015 51 3 p u t e S r e t e M 52 Language Selection Use this setting to select the meter language. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. From the Screen menu, touch Language Selection. The current language setting is highlighted (white type on a blue background). You can select either:
Dansk Deutsch English Espaol Franais Italiano Nederlands Norsk Portugus Suomi Svenska Language 09:15 am Dansk Deutsch English Espaol Franais 05/29/2015 Setting the date 4 Touch on the screen. or to display the language of choice If the arrow is just an outline the end of the list in the repective direction.
, you have reached 5 6 Touch the button to select the language of choice. Your selection is now highlighted. to exit Touch this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch When you power on the meter for the first time (or after a long period without power), the input field for the date automatically appears first. The date (and time) must be entered before the meter can be used further. If at a later time a date adjustment is needed, go to the Setup Menu, then select the menu of choice. Both Date and Time display formats are controlled by the Format options you select (see page 56). Options shown in the Date and Time menus may vary depending on the chosen formats. You can choose between the following display formats:
Date: Day.Month.Year, e.g., 29.05.2015 Date: Month/Day/Year, e.g., 05/29/2015 Date: Year-Month-Day, e.g., 2015-05-29 Time: 24H or 12H 53 3 p u t e S r e t e M 54 Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 6 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. From the Screen menu, touch Date/Time. From the Date/Time menu, touch Set Date. Touch then the day. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to set the year, then the month, to save this setting, or touch and If this setup menu appeared automatically after powering the meter on, you must touch date setting. to complete the first 7 Touch to return to the Screen menu. Date/Time 09:15 am Set Date Set Time Format Date 09:15 am Year:
2015 05/29/2015 Month:
Day:
5 29 05/29/2015 Setting the time When you power on the meter for the first time (or after a long period without power), this Time setup menu appears automatically after you set the date. If at a later time a time adjustment is needed, go to the Setup Menu, then select the menu of choice. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 6 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. From the Screen menu, touch Date/Time. From the Date/Time menu, touch Set Time. Touch utes. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to set the hours, then the min-
to save this setting, or touch and If this setup menu appeared automatically after powering the meter on, you must touch time setting. to complete the first 7 Touch to return to the Screen menu. Date/Time 09:15 am Set Date Set Time Format 05/29/2015 Time 09:15 am Hour:
Minute:
9 59 AM PM 05/29/2015 55 3 p u t e S r e t e M 56 Setting the display options for date and time Select your preferred format for the date and time display. Main Menu 09:15 am Setup Menu 09:15 am Screen 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Contrast Result Units Result Con rmation Language Selection Date / Time 05/29/2015 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Screen. 2 From the Screen menu, touch Date/Time. 3 From the Date/Time menu screen, touch Format. 4 The current settings are highlighted. You can select one of the following display formats:
Date: DD.MM.YYYY (Day.Month.Year), e.g., 29.05.2015 Date: MM/DD/YYYY (Month/Day/Year), e.g., 05/29/2015 Date: YYYY-MM-DD (Year-Month-Day), e.g., 2015-05-29 Time: 24H or 12H Touch the button with the display format of choice for date and time. Your selection is now high-
lighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Touch to return to the Screen menu. to save this setting, or touch 5 6 7 Date/Time 09:15 am Set Date Set Time Format 05/29/2015 Format 09:15 am Date:
DD.MM.YYYY MM/DD/YYYY YYYY-MM-DD Time:
24H 12H 05/29/2015 57 3 p u t e S r e t e M 58 3.3 Options setup Sort Sort refers to the order in which measured and stored results are displayed when you use the Review Results function of the CoaguChek Pro II meter. You can display stored results chronologically by date and time or by per-
son, based on the Patient ID. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Sort Beeper Auto Off Connection Parameter Selection 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Options. From the Options menu, touch Sort. The current setting is highlighted. You may select from the following sort options:
4 By Date/Time By Patient ID By Patient Name Touch the button to select the Sort by option of choice. Your selection is now highlighted. The sort option Patient Name is available only when used together with a patient list. Patient lists can only be created with a DMS. For more details see Data han-
dling, starting on page 139. 5 to save this setting, or touch Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Sort 09:15 am Sort By:
Date / Time Patient ID Patient Name 05/29/2015 59 3 p u t e S r e t e M 60 Beeper The CoaguChek Pro II meter can display information visu-
ally and alert you to special circumstances with a Beeper. The meter always beeps when it is switched on. When the Beeper function is enabled the meter beeps once when:
it detects a test strip pre-heating of the test strip is complete and you need to apply a sample it detects a sample the test is completed and the results are displayed
(a long beep) an error occurs (three short beeps) an external power adapter is connected when the meter is on the meter is docked a barcode is scanned We recommend that you keep the Beeper enabled at all times. You can also activate a Key Click. When a Key Click is enabled, the meter clicks briefly every time a button is touched, facilitating the input of information. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 Beeper 09:15 am Off Low Medium High Key Click:
On Off 05/29/2015 Screen Options ID Setup QC Settings Diagnostics 05/29/2015 1 Sort Beeper Auto Off Connection Parameter Selection 05/29/2015 From the Main Menu, touch Setup to open the meter settings.. From the Setup Menu, touch Options. From the Options menu, touch Beeper. 2 3 The current setting is highlighted. You may select from the following options:
For the Beeper Off Low Medium High For the Key Click 4 5 On Off Touch the button with the desired setting for the Beeper, then touch the button with the setting of choice for the Key Click. Both selections are now highlighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch 61 3 p u t e S r e t e M 62 Auto Off You can set up your CoaguChek Pro II meter so that it powers itself off automatically if it has not been used (no buttons touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the battery pack. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Sort Beeper Auto Off Connection Parameter Selection 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Options. From the Options menu, touch Auto Off. If the meter is connected to the power adapter or the Handheld Base Unit, the Auto Off function has a differ-
ent effect:
The meter powers itself off after 10 minutes without user interaction, regardless of the selected settings Auto Off 09:15 am Minutes:
You may select from the following options:
5 05/29/2015 Connection 4 5 Off (meter never powers itself off) Time until meter powers itself off:
110, 15, 20, 25, 30, 40, 50, 60 minutes Touch utes or to switch the feature off. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to select the time of choice in min-
to save this setting, or touch or In the Connection menu you can configure the data exchange with external devices. The meter can be con-
nected either to a computer (DMS) or a printer. In addi-
tion to this direct data output, test results may also be encoded as QR codes, which can be scanned to be used with other applications. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Sort Beeper Auto Off Connection Parameter Selection 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Options. From the Options menu, touch Connection. 63 3 p u t e S r e t e M 64 QR Code Connection 09:15 am QR Code Off Computer QR Code Show QR code:
09:15 am On Off Printer Plain Text 05/29/2015 Coded Data URL Transmission 05/29/2015 4 5 From the Connection menu, touch QR Code. Touch On to enable, or touch Off to disable QR code display. Your selection is now highlighted. If you have enabled this feature, select the style of the QR code to be displayed:
Plain Text Use this option to scan the result into a PC hosted application (e.g. electronic medical record). In order to do so, you need an external 2D barcode scanner attached to your PC. Once scanned, the test result and related meta-information (e.g. date, time, comments) will appear as plain text in your PC application. Ensure that your environment for reading QR codes
(QR code reader, operating system, text processing application) is appropriate for your language. Disregard may lead to unpredictable behavior of your receiving component (PC, mobile device). Coded Data Use this option to scan the result into a smartphone or tablet app, or a PC hosted application. URL Transmission Use this option to upload the result to a web based service (e.g. such as an electronic health record, coagulation management software, etc.). For this option further parameters (URL, encryption key) must be set. For the options Coded Data and URL Transmission dedicated software programs or apps are required in order to use this feature. If you are a customer or a 3rd party IT provider, and you are interested to use this feature, contact your local Roche Diagnostics repre-
sentative for additional information. 6 Touch Plain Text, Coded Data or URL Transmission, depending on the intended use. Your selection is now highlighted. If you have selected URL Transmission, the become active. Use this button to set the additional parameters. button will 7 8 9 to open the URL Transmission menu. Touch Touch URL to enter the URL to which the test result data will be uploaded (note: the URL will be pro-
vided by your specialized service provider). 123 ABC to switch to input of numbers. to switch back to input of text. to backspace and correct a mistake. to save this setting, or touch Use Use Use Touch this menu without saving any changes. The display automatically returns to the previous screen. to exit QR Code Show QR code:
09:15 am On Off Plain Text Coded Data URL Transmission URL Transmission 09:15 am 05/29/2015 URL Encryption Key 05/29/2015 URL 09:15 am A F K P U Z B G L Q V
. E J O T Y C H M R W
/
D I N S X 123 65 3 p u t e S r e t e M 66 URL Transmission 09:15 am URL Encryption Key 05/29/2015 Encryption Key 09:15 am Key:
JD5G29F6U8V2WC4L Serial No.:
UQ85464711 Note: The encryption key and the serial number are required to decrypt QR code messages from this meter. Ensure they are available on the target sys-
tem. 10 Touch Encryption Key to display the Encryption Key menu. The Encryption Key menu displays two types of informa-
tion which are required in order to identify and decode the transmitted test result. This information is required by the IT system, to which the test result is transmitted via the defined URL. This information needs to be exchanged once with your specialized service provider prior to using the URL transmission method. Contact your specialized service provider in order to exchange this information. 05/29/2015 11 12 Key This key is auto-generated by the meter and is required to decrypt the QR code information. Serial No. The meter's serial number is required to map the test result to the encryption key. Touch the New button, if you want the meter to generate a new encryption key. twice to return to the QR Code menu. to exit Touch Touch this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch Computer Connection 09:15 am QR Code Off Computer Printer 05/29/2015 The CoaguChek Pro II meter can connect with a compu-
ter or host system running appropriate software (that is, a DMS must be installed). To use this connectivity feature, however, you need the optional Handheld Base Unit or the meter must be configured for wireless communica-
tion. If no wireless communication is configured, the connection is established in two steps. The meter connects to the Handheld Base Unit via infrared. The Handheld Base Unit is either connected to a single computer (via USB) or to a network/host system (via ethernet). The option Computer (when activated) can be used together with a DMS to set up:
operator lists, or patient lists (lists of patients to be tested) This eliminates the need for manual entry of these data. In addition, you can transfer test results stored in the meter to other systems for archiving or further evaluation. The option Computer controls the meters ability to com-
municate with a computer or a network. 13 14 Touch Computer. Your selection is now highlighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. 67 3 p u t e S r e t e M 68 Printer The CoaguChek Pro II meter can also connect directly to a printer. To use the printing feature you need an optional infrared printer. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Sort Beeper Auto Off Connection Parameter Selection 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Options. From the Options menu, touch Connection. Touch Printer. Your selection is now highlighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch To print :
Align the meter with the IR printer. At any test or memory screen, touch
. The printer icon only appears if the printer function is activated. Otherwise it is not displayed. If you work with the meter in a language other than English: With the exception of information you have entered - such as patient ID and name, operator ID, comments - the printout will be in English. (See Lan-
guage Selection on page 52.) Connection 09:15 am Off Computer Printer 05/29/2015 Memory 09:15 am P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/28/2015 11:31 am 2.5INR 21%Q Doctor Noti ed Sick Travel 05/29/2015 Parameter Selection When performing a test, the meter can be set to display a screen that allows the operator to select the test parame-
ter to be used. Otherwise the meter will determine the test parameter by reading the test strip (barcode) infor-
mation from the inserted test strip. Main Menu 09:15 am Setup Menu 09:15 am Options 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Sort Beeper Auto Off Connection Parameter Selection 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Options. From the Options menu, touch Parameter Selection. Touch Enable to display the parameter selection screen prior to each test or touch Disable to have the meter select the parameter by reading the test strip information. Touch to save this setting, or touch this menu without saving any changes. to exit Select Param. 09:15 am Enable Disable 05/29/2015 69 3 p u t e S r e t e M 70 3.4 ID Setup Use the ID Setup menu to enter settings for user man-
agement and patient management. These settings are optional and set to Off/Inactive by default; the meter can be operated without these settings. There are three types of identification used with the meter:
System Administrator: The Admin. (Administra-
tor) has special rights to enter certain meter set-
tings and is the only one who can enter and change these settings. It is not necessary for Admin. identi-
fication to be activated to use the CoaguChek Pro II meter. However, it might be desired or necessary, depending on the regulatory environment and the site of use. Operator: The Operator ID is assigned to persons who use the meter to run tests. If you want to use Operator IDs, you have several options:
You may use Operator IDs to restrict the use of the meter to qualified personnel or a predefined group of users. In this case an operator list created exter-
nally must be transferred to the meter, enabling you to select an Operator ID when logging in. For more details see Data handling, starting on page 139. You may use Operator IDs for informational pur-
poses only, in order to assign stored measurement results to the users who performed the test. In this case Operator IDs may be entered directly on the meter (by keypad or scanner), with or without an operator list being available. Patient: The Patient ID is assigned to the person, whose test results are recorded. You can either:
block input of a unique Patient ID (in this case, every test is simply numbered in consecutive order) allow a unique Patient ID as optional, or require a unique Patient ID for every test. Patient lists created externally can also be transferred to the meter, enabling you to select Patient IDs for a test from these lists. For more details see Data handling, starting on page 139. Operator IDs can be selected from a list (if available) or read by the barcode scanner on the side of the meter. If passwords were created, they must be entered via the onscreen keypad. Patient IDs can be entered by using the onscreen keypad or the barcode scanner on the side of the meter. For more information on working with operator and patient ID barcodes, see Data handling, starting on page 139. The buttons in the ID Setup menu show what the current settings are (this is just an example, the screen may look different on your meter):
The standard display of the Admin. button means the function is available but not activated (a pass-
word for the system administrator/supervisor has not been assigned). The standard display of the Operator button means the Operator login is available but not acti-
vated. When the Patient button is highlighted (that is, when it has a blue background) this means the function is available and activated (either as Optional or Required). 71 3 p u t e S r e t e M ID Setup 09:15 am Admin. Operator Patient 05/29/2015 72 System Administrator (Admin.) In the default setting, the meter is not protected with an Admin. ID, and all setup options are accessible to every user. If you set up an Admin. ID, the following setup areas are automatically reserved only for the system adminis-
trator/supervisor (i.e., the person who knows the password). Screen: Result Units, Result Confirmation, Date/
Time Options: Connection (to a computer or a printer) ID Setup (the entire area) QC Settings (the entire area) Diagnostics: Software, Hardware, Memory, Wireless Setup When you enter an Admin. ID, this ID will have to be entered from this point forward before any of the set-
tings above can be changed. The Admin. ID must also be entered before you can delete or change the Admin. ID itself. If you forget the Admin. ID, contact your Roche Diagnostics representative. If an Admin. ID has not been set up yet:
Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Admin. Operator Patient 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch ID Setup. From the ID Setup menu , touch Admin.
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A F K P U Z 0 5
|
Admin. 09:15 am B G L Q V C H M R W E J O T Y D I N S X 123 Admin. 09:15 am 1 6 2 7 3 8 4 9 ABC 09:15 am E J O T Y D I N S X 123 Repeat ID
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A B G L Q V C H M R W F K P U Z 4 Using the keypad displayed on the screen, enter the Admin. ID of choice. The ID can consist of up to 20 characters. Pay close attention to the buttons you press, because the characters are not displayed on the screen. Aster-
isks are displayed instead (as if entering a password on a computer). 5 6 7 8 9 10 123 ABC to save this setting, or touch to switch to input of numbers. to switch back to input of text. to backspace and correct a mistake. Use Use Use Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Enter the Admin. ID again (the keypad is automati-
cally displayed again on the screen) to confirm the first entry. Touch set), or touch not set and is therefore still inactive. to save this entry, (the Admin. ID is now to exit this menu, the Admin. ID is The display automatically returns to the ID Setup menu. After you exit the Setup Menu, only an authenticated administrator may further edit the setup areas as listed before (see page 72). 73 3 p u t e S r e t e M 74 Changing an existing Admin. ID:
Main Menu 09:15 am Setup Menu 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics
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A F K P U Z Admin. 09:15 am ID Setup 09:15 am Admin. Operator Patient B G L Q V C H M R W E J O T Y D I N S X 123 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch ID Setup. Using the keypad displayed on the screen, enter the current Admin. ID. The ID Setup menu is displayed. The Admin. button is highlighted, which means an Admin. ID is active. 4 5 Touch Admin. Using the keypad displayed on the screen, enter
(and confirm) the new Admin. ID of choice. Deactivating an existing Admin. ID:
Main Menu 09:15 am Setup Menu 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics
***|
A F K P U Z Admin. 09:15 am ID Setup 09:15 am Admin. Operator Patient B G L Q V C H M R W E J O T Y D I N S X 123 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch ID Setup. Using the keypad displayed on the screen, enter the current Admin. ID. The ID Setup menu is displayed. The Admin. button is highlighted, which means an Admin. ID is active. 4 5 Touch Admin. Immediately touch screen without entering a password. to close the keypad on the The Admin. ID has been deleted and therefore deacti-
vated. The Admin. button is no longer highlighted. ID Setup 09:15 am Admin. Operator Patient 05/29/2015
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A F K P U Z Admin. 09:15 am B G L Q V C H M R W E J O T Y D I N S X 123 75 3 p u t e S r e t e M 76 Operator ID If you want to create a list of Operator IDs from which you can select an operator, additional software (a data management system) and the Handheld Base Unit are required (for more details see Data handling, starting on page 139). In the default setting, the Operator login is not activated. You can either activate or deactivate Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be displayed and measurements can be performed. To activate Operator login:
Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics Admin. Operator Patient 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch ID Setup. From the ID Setup menu, touch Operator. Touch the button with the setting of choice for set-
ting up the Operator login. Your selection is now highlighted. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch Operator ID 09:15 am Inactive Active 05/29/2015 Patient ID If you want to create a list of Patient IDs from which you can select a patient for testing, additional software (a data management system) and the Handheld Base Unit are required (see page 139). In the default setting, input of Patient IDs is set to No. This means each test is simply assigned a consecutive number. However, you can require that a Patient ID be entered or make it optional. Main Menu 09:15 am Setup Menu 09:15 am ID Setup 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 Patient ID 09:15 am No Optional Required 05/29/2015 Screen Options ID Setup QC Settings Diagnostics Admin. Operator Patient 05/29/2015 05/29/2015 1 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch ID Setup. From the ID Setup menu, touch Patient. 2 3 You may select from the following options:
4 5 No (tests will be assigned numbers automatically) Optional (automatic numbering or list/scan/manual input) Required (list/scan/manual input) Touch the button with the setting of choice. Your selection is now highlighted. Touch to save this setting, or touch this menu without saving any changes. to exit The settings for the option No are now completed. For the options Optional and Required, continue by selecting the input format. 77 3 p u t e S r e t e M 78 Patient ID 09:15 am Alphanumeric Numeric Min. Length:
Max. Length:
1 20 05/29/2015 Select the form for input of the Patient ID. 6 You may select from the following options:
7 8 9 Alphanumeric Enter any combination of letters and numbers, e.g., J. DOE 3378 Numeric Enter numbers only, e.g., 3387 Min. Length Enter the minimum number of characters (1 20) the Patient ID must have. Max. Length Enter the maximum number of characters (1 20) the Patient ID can have. Touch the button with the format of choice for the Patient ID. Your selection is now highlighted. Touch
(length) of choice. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to set the number of characters to save this setting, or touch or 3.5 QC Settings setup The QC Settings menu contains options for enforcing the performance of liquid quality controls by the operator at specified intervals. It also provides the option of custom-
izing the QC Range in accordance with applicable local guidelines. QC Range There are two options:
Default Range: The meter displays the QC Range provided by Roche Diagnostics in the code chip. Custom Range: The option Custom Range lets the user define their own QC Range within the default range. Lockouts (QC Lockout and Operator Lockout) If the liquid quality control test is not performed correctly, or if the result is outside the target value range, the meter is locked from further use. The Lockout can also be set up selectively for individual operators. A liquid quality control test must be completed success-
fully before the meter is available again for testing (either by the operator or in general). The option of setting up an Operator Lockout is availa-
ble only when operator lists are created on a data man-
agement system (DMS), stored in the meter, and Operator login is activated. These lists are only available in connection with a data management system. For more details see Data handling, starting on page 139. Scan QC Material The barcode scanner of the CoaguChek Pro II meter can be used to scan barcodes from QC material vials. This function can be set to Optional or Scan Only. When set to Scan Only, the operator will not be able to manually select a QC lot number from a list. 79 3 p u t e S r e t e M 80 QC Range Liquid quality control ranges can be customized to comply with local guidelines. The QC Range function enables you to narrow the default range individually for each test parameter. Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics QC Range Lockouts Scan QC Material 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch QC Settings. From the QC Settings menu, touch QC Range. From the QC Range menu, touch the button of the test parameter you wish to set. You may select from the following options:
5 Default Range (Range provided in the code chip is selected and displayed. No target value is dis-
played.) Custom Range (The allowed percentage deviation from target value can now be customized. Addi-
tionally, you can choose between displaying the target value along with a control test result or not displaying the target value with the control test result.) Touch the button with the setting of choice. Your selection is now highlighted. QC Range 09:15 am PT aPTT QC Range 09:15 am Par:
aPTT 05/29/2015 Default Range Custom Range 05/29/2015 QC Range 09:15 am Par:
aPTT Default Range Custom Range 05/29/2015 QC Range 09:15 am Display target value On Off Deviation from target value 11.5 %
05/29/2015 to save to exit this menu without If you selected Default Range, touch this setting, or touch saving any changes. If you selected Custom Range, touch to pro-
ceed with corresponding settings, or touch to exit this menu without saving any changes. The dis-
play automatically returns to the previous screen. If you selected Custom Range, the QC Range screen opens and offers you the following options:
Display target value (On/Off) Deviation from target value (percentage value). See page 80. For the control solutions, the target value always comes from the information stored in the code chip. If you have chosen Custom Range, you can now select an allowed deviation from target value in the range of 0 to 22.5% (in the illustration, 11.5%). Note: For the test parameter PT, the percentage deviation from the target value is always defined using INR values. Even if you have activated % Quick in the setup, the meter always calculates the devia-
tion using INR values; This range is then converted to
% Quick in a second step. As there is no linear correla-
tion between values expressed as INR and values expressed as % Quick, if you calculate the percentage deviation (11.5 % in the example) using the % Quick target value, your result may deviate from the result cal-
culated by the meter using the INR target value. 81 3 p u t e S r e t e M 82 QC Range 09:15 am Display target value On Off Deviation from target value 11.5 %
05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 2 Par:
PT 05/29/2015 09:15 am 3.0 INR
(2.6 - 3.2 INR) 16 %Q
(16 - 20 %Q) 05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 2 Par:
PT 05/29/2015 09:15 am 3.0 INR
(2.9, 2.6 - 3.2 INR) 16 %Q
(17, 16 - 20 %Q) 05/29/2015 6 7 Touch On (the target value will be displayed with a test result) or Off (the target value will not be dis-
played). Your selection is now highlighted. Use the arrows to to set the allowed percentage deviation from the target value. Use the arrows on the left to adjust the number before the decimal point. Use the arrows on the right to adjust the number after the decimal point. 8 to save this setting, or touch Touch to exit this menu without saving any changes. The display automatically returns to the QC Settings screen. The Custom Range and Target Value (if set to On) appear in a line below the control test result in the QC test and QC memory screens. In the left hand screen, Display target value is set to Off:
the custom range only is displayed below the control test result. In the right hand screen, Display target value is set to On:
both the custom range and the target value are displayed. The target value (here: 2.9) appears in front of the custom range. QC (quality control) Lockout QC Lockout ensures that the optional quality control tests are run on a regular basis. This is independent of the operator, however. This option should be used if you work without operator lists. QC Lockout is disabled by default. For routine confirma-
tion of system reliability it is recommended to enable this feature. It is also possible to enable Operator Lockouts and QC Lockouts in parallel. In addition to defining time intervals or numbers, QC Lockout can also be used to specify that a quality control test must be carried out when a new test strip lot is used (New Code). The lockout triggers are set once and are valid for all parameters. The events (time intervals, numbers) trig-
gering the lockouts are counted individually for each parameter. Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Lockouts 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics QC Range Lockouts QC Lockout Operator Lockout Scan QC Material STAT Test Con g. 05/29/2015 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch QC Settings. From the QC Settings menu, touch Lockouts. From the Lockouts menu, touch QC Lockout. Select the triggers for a quality control test, based on lot and/or time or number of strips. 83 3 p u t e S r e t e M 84 QC Lockout 09:15 am New Code Yes No No Daily Weekly Monthly 05/29/2015 QC Lockout 09:15 am New Code Yes No Weekly Monthly No. of Hours No. of Strips 05/29/2015 You may select from the following options:
New Code Yes/No (applies every time a new test strip lot is used) The general intervals are:
6 7 No Daily Weekly Monthly No. of Hours No. of Strips Touch the button with your chosen option when changing the test strip lot. Touch and on the screen. to display the interval of choice The date based intervals (Daily, Weekly, Monthly) each start at 00:00 (midnight) on every day, every Monday or every first day of the month. QC Lockout 09:15 am New Code Yes No QC Lockout 09:15 am Number of strips (1-999):
QC Lockout Number of Levels 09:15 am Weekly Monthly No. of Hours No. of Strips 450 One Level Two Levels 05/29/2015 05/29/2015 05/29/2015 8 9 10 11 12 13 to exit this menu to proceed, or touch Touch the button to select the interval of your choice. Your selection is now highlighted. Touch without saving any changes. If you have selected either No. of Hours or No. of Strips, enter the corresponding number now. Touch without saving any changes. For every option except for No, you must now indicate the number of levels at which the quality control must be performed. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch to proceed, or touch to exit this menu 85 3 p u t e S r e t e M 86 Operator Lockout Optional liquid quality controls can be used to ensure that an operator is performing tests properly on the CoaguChek Pro II meter. The Operator Lockout function constrains an operator, who has been set up in the list, to perform these quality controls on a regular basis. Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Lockouts 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics QC Range Lockouts QC Lockout Operator Lockout Scan QC Material STAT Test Con g. 05/29/2015 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch QC Settings. From the QC Settings menu, touch Lockouts. From the Lockouts menu, touch Operator Lock-
out. If this button is disabled (grayed out), either no operators have been set up or the Operator ID option has been deactivated. The option of setting up an Operator Lockout is availa-
ble only when operator lists are created on the DMS. For more details see Data handling, starting on page 139. If you are not working with a DMS, only the QC Lockout is available (see QC (quality control) Lock-
out on page 83). Op. Lockout 09:15 am Op. Lockout 09:15 am No Weekly Monthly Every 3 Months Every 6 Months 05/29/2015 Weekly Monthly Every 3 Months Every 6 Months Yearly 87 Op. Lockout Number of Levels 09:15 am One Level Two Levels 05/29/2015 5 05/29/2015 Select the interval of choice in which the mandatory quality control tests must be performed. You may select from the following options:
6 7 8 9 10 to display the interval of choice No (deactivated) Weekly Monthly Every 3 Months or Every 6 Months Yearly Touch and on the screen. Touch the button to select the interval of your choice. Your selection is now highlighted. Touch without saving any changes. For every option except for No, you must now indicate the number of levels at which the quality control must be performed. Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. to save this setting, or touch to proceed, or touch to exit this menu 3 p u t e S r e t e M 88 STAT Test Configuration Quality control tests ensure consistent quality and accu-
rate measurements. In emergency situations, however, it may be necessary to perform a test without delay. To override an active lockout1, you can allow STAT Tests
(STAT = Short TurnAround Time). You can set the number of tests (up to nine) permitted beyond the lockout. Once the number of STAT Tests allowed has been reached, additional tests cannot be performed until you have successfully completed a qual-
ity control test. The default setting is three STAT tests. The results of STAT tests are always identified by the label STAT Test when they are displayed (see page 115). The number of STAT tests performed is counted per test parameter used. Once the maximum number of STAT tests has been reached, this parameter cannot be tested without performing a control test first. Other test parameters that have not yet reached this limit are still available. 1. QC, operator, or new lot lockout Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Lockouts 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics QC Range Lockouts QC Lockout Operator Lockout Scan QC Material STAT Test Con g. 05/29/2015 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 6 7 STAT Test 09:15 am Enable Disable 3 05/29/2015 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch QC Settings. From the QC Settings menu, touch Lockouts. From the Lockouts menu, touch STAT Test Config. Touch Enable to allow STAT Tests or touch Disable to prohibit STAT Tests. Your selection is now highlighted. If you have enabled the option, touch set the number of additional tests. Touch to save this setting, or touch this menu without saving any changes. to exit and to 89 3 p u t e S r e t e M 90 Scan QC Material The barcode scanner of the CoaguChek Pro II meter can be used to scan barcodes from QC material vials. Main Menu 09:15 am Setup Menu 09:15 am QC Settings 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics QC Range Lockouts Scan QC Material 05/29/2015 05/29/2015 05/29/2015 1 2 3 4 5 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch QC Settings. From the QC Settings menu, touch Scan QC Material. Touch Optional to allow manual selection of a QC lot number from a list or touch Scan Only to prohibit manual selection. Your selection is now highlighted. Touch to save this setting, or touch this menu without saving any changes. to exit Scan QC Mat. 09:15 am Optional Scan Only 05/29/2015 3.6 Diagnostics Under Diagnostics, you will find information about the system, such as software version, number of data records stored, and configuration details. The diagnostics screens shown here are for illustration purposes only. The Infor-
mation shown on your meter may differ. Main Menu 09:15 am Setup Menu 09:15 am Diagnostics 09:15 am Patient Test Control Test Review Results Setup Screen Options ID Setup QC Settings Diagnostics General Software Hardware Memory Usage Wireless Setup 05/29/2015 05/29/2015 05/29/2015 1 2 3 From the Main Menu, touch Setup to open the meter settings. From the Setup Menu, touch Diagnostics. From the Diagnostics menu, touch the button of the diagnostics screen you want to display. 91 3 p u t e S r e t e M 92 General 09:15 am Software 09:15 am Hardware 09:15 am Memory Usage 09:15 am Meter name:
CoaguChek Pro II Home location:
Mannheim Last synchronization:
05/28/2015 Non-transmitted results:
21 Next scheduled control test:
05/30/2015 00:00 Build:
Boot:
Kernel:
Rootfs:
App:
MM-BL:
MM-FW:
04.00.00 00.16.31 00.21.30 00.16.01 04.00.00 0.80 5.00 Serial no.:
U76001234 HBM HW:
3.53a MM HW:
03 Patient Tests:
in use/max. (no.):
Control Tests:
in use/max. (no.):
Patient List:
in use/max. (no.):
Operator List:
in use/max. (no.):
1300/2000 350/500 2700/4000 1250/5000 Tests until lifetime end:
11455 05/29/2015 05/29/2015 05/29/2015 05/29/2015 Wireless Setup 09:15 am Wireless Setup 09:15 am Wireless Setup - Network Wireless Setup - Connection Use DHCP:
Use DNS:
SSID:
WLAN:
MAC:
Enabled Disabled SSID123456 1A 3E B6 78 9C AF DMS Name:
DMS Port Number:
DMS IP Address:
RF Security:
POCT Server 4711 192.168.3.21 WPA2-PSK (AES) 09:15 am Test Wireless Setup Wireless Setup - Test RF activated:
Associated:
Authenticated:
Received IP:
IP:
Subnet:
Gateway:
DNS:
Contacted DMS:
Connected to DMS:
Completed:
192.168.3.21 255.255.255.0 05/29/2015 05/29/2015 05/29/2015 to toggle between the Wireless Setup 4 5 and Use screens. In either diagnostics screen, touch the Diagnostics menu. to return to 4 Testing a Blood Sample 93 4.1 Important notes What you need:
CoaguChek Pro II meter CoaguChek PT and/or aPTT Test Strips with matching code chip When testing with venous blood:
Standard blood collection device (syringe) When testing with capillary blood:
Lancing device approved for professional use (e.g., the Accu-Chek Safe-T-Pro Plus lancing device or the CoaguChek Lancets) CoaguChek Capillary Tubes/Bulbs (optional) Do not use glass capillary tubes or capillary tubes that contain anticoagulants. Cotton ball and alcohol wipe Always close the strip container immediately after remov-
ing a test strip. operate the meter at an ambient temperature between 12 C and 32 C (54 F and 90 F). place the meter on a level, stable surface (table) or hold it so it is roughly horizontal. follow the information on correct handling of test strips in the package insert. keep the test strip guide and housing clean. See also the chapter entitled Maintenance and Care
(starting on page 147). l 4 e p m a S d o o B a l g n i t s e T 94 Protection against infection:
When collecting samples always observe the general precautions and guidelines relating to blood sampling
(see page 17). Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice (see page 17) Never store the meter at high temperatures (above 35 C or 95 F) while it is in regular use. store the meter in damp or humid conditions with-
out protection. remove or insert the code chip while the meter is performing a test. touch or remove the test strip during a test. wait more than 15 seconds after a fingerstick before applying the blood. fingerstick a patient with wet hands (residues of water, sweat, or alcohol). add more blood after the test has begun. perform a test with a drop of blood from a previous puncture. CAUTION Accuracy/precision of measured results:
Failure to comply with the above may lead to inaccurate results. An incorrect result may lead to an error in diag-
nosis, therefore posing danger to the patient. Getting a good capillary blood sample 95 Prepare the selected blood collection site and obtain blood from the patient per facility policy. If no facility policy exists for obtaining capillary blood, follow these recommendations:
Warm the hand. Have the patient hold it under his or her arm or use a hand warmer. Wash hands with soap and warm water, disinfect the blood collection site. Dry thoroughly. Have the patient let that arm hang down by his or her side before lancing a finger. Massage the finger from its base. Use these techniques until the fingertip has increased color. Immediately after lancing, massage gently along the side of the finger to obtain a sufficiently large blood drop without pressing or squeezing too hard. Apply the blood drop to the test strip immediately
(within 15 seconds). Optionally, you may use a CoaguChek Capillary tube/bulb to collect the fingerstick blood sample. CAUTION When washing and disinfecting the patient's finger, allow it to dry thoroughly. Residues of water or disinfectant on the skin can dilute the drop of blood and so produce false results. l 4 e p m a S d o o B a l g n i t s e T 96 Getting a good result from venous whole blood For sample collection use a standard blood collection device. Do not use anti-coagulants (e.g., EDTA, citrate, fluoride, oxalate, or heparin) to collect the blood sample. Venous blood samples may be collected from a venous line. If venous samples are collected by venipuncture, note the following:
Use a needle at least 23 G (approx. 0.65 mm) or larger in size. Discard the first four drops of blood collected
(within the first 10 seconds). Then immediately apply one drop of blood (at least 8 L) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample. Protection against infection:
When collecting samples always observe the general precautions and guidelines relating to blood sampling
(see page 17). Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice (see page 17) 4.2 Preparing to test 97 Test strip code chip 1 2 Have the test strip container at hand. Make sure that the code chip supplied with these test strips is at hand. Each box of test strips (PT, aPTT) contains a code chip. The parameter, the number on the code chip and the number on the test strip container must match. A capital S in front of the number indicates that this code chip is for test strips. (A capital C in front of the number indicates that it is a control solution code chip. See Chapter 5, Control and Proficiency Testing). The code chip provides the meter with important infor-
mation that it needs to perform the coagulation test. The chip contains information about the test method, the lot number, and the expiration date. The code chip is required, whenever a new test strip lot is used, so that the meter can read and store the lot information about that particular lot of test strips. The CoaguChek Pro II meter stores the data from up to 60 test strip code chips that have been inserted. Do not forget to use the test strip code chip that is supplied with each pack of test strips before you perform the first test with these strips. We recom-
mend that you leave the code chip in the meter to protect the electrical contacts in the meter from becoming dirty. Each code chip belongs to a particular lot of test strips. Only remove the code chip when you are testing with test strips taken from a new pack. Protect the code chip from moisture and equipment that produces magnetic fields. l 4 e p m a S d o o B a l g n i t s e T 98 Inserting the code chip 1 Remove the old code chip, if one is inserted in the meter. 2 Check that the number on the code chip matches the number on the label of the test strip container. 3 Slide the new code chip into the code chip slot (as shown) until you feel it snap into place. If the code chip is missing or incorrectly inserted, a corre-
sponding error message appears in the display (refer to the Troubleshooting section of this manual). Powering on the meter 99 1 2 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. Power the meter on by pressing
. You can also power on the meter directly by inserting a test strip or connecting the power adapter. The next steps depend on whether you work with the function Operator ID set to inactive or active (see Data handling on page 139). Main Menu 09:15 am 3 Wait until the Main Menu is displayed. If the function Operator ID is inactive:
Patient Test Control Test Review Results Setup 05/29/2015 l 4 e p m a S d o o B a l g n i t s e T 100
|
A F K P U Z Operator ID 09:15 am E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan If the function Operator ID is active:
Without operator list:
3 You are now prompted to enter an Operator ID1. Enter the Operator ID using the keypad. Touch to move to the next screen. Alternatively, the Operator ID can also be entered using the built-in barcode scanner2. Touch Scan and scan the operator barcode from a dis-
tance of approx. 10-20 cm (4-8 inches), according to the barcode size. The meter beeps once the bar-
code has been read successfully. The barcode information appears in the operator ID field. The scanner turns off after 10 seconds, if a barcode is not scanned. 1. 2. For configuring operator and patient IDs, see page 145. A list of supported barcode symbologies can be found in Appendix A.2 on page 166, a list of supported characters in Appendix A.3 on page 169. 101 Operator 09:15 am Alan Smithee Jane Brown Ann Casey Joe Dalton Scan 05/29/2015 Password 09:15 am 1 6 2 7 3 8 4 9
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0 5 ABC Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 05/29/2015 With operator list:
3 4 Wait until the operator list is displayed. Select the operator of choice by touching the corresponding button or touch Scan to scan an operator barcode. Note: Scanned operator IDs must also be on the list. Otherwise the login attempt will fail and an error mes-
sage will be displayed. 5 6 7 Enter the (optional) password. to log on. After you enter the password, touch The Main Menu is displayed and you can start the test. When you touch played again.
, the operator pick list is dis-
When the tests are completed or another operator wants to perform additional tests, touch Logout to log out (this button is available only when the Operator ID is acti-
vated). The meter returns to the display of the operator pick list. Note: Extended data handling functionality and opera-
tor login options are dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. For more details see Data han-
dling, starting on page 139. l 4 e p m a S d o o B a l g n i t s e T 102 4.3 Performing a test Main Menu 09:15 am 1 Check the battery level. Patient Test Control Test Review Results Setup 05/29/2015 Main Menu 09:15 am QC Lockout Control Test Review Results Setup Logout 05/29/2015 Main Menu 09:15 am QC!
Patient Test Test 09:15 am QC status PT aPTT
-
-
3 Locked Control Test Review Results Setup Logout 05/29/2015 05/29/2015 If the battery icon turns red (one bar left), there may not be enough power left for another test. If there are no bars left in the battery icon, you cannot perform any more tests. Power the meter off by pressing
. In both cases, restore power by recharging the battery pack, or using the power adapter. 2 Check that the date and time are correct. Correct any wrong entries as described in Chapter 3, Meter Setup/Setting the date. If a lockout (Operator or QC Lockout) is displayed instead of the Patient Test button, you must run a liquid quality control test before you can perform a patient test (refer to Chapter 5, Control and Proficiency Testing). When the meter is in lockout status, a patient test cannot be performed. The next steps depend on whether you work with or without patient lists. If the Patient Test button is available, but a lockout is displayed (QC!), one or more test parameters are locked. A test can only be performed for parameters that are still unlocked or as a STAT test (if this function is enabled and if there are still STAT tests available). In these cases a QC status screen will be displayed after touching Patient Test. For more details on STAT test configuration see pages 88 and 115. 103 Without patient list Touch Patient Test. If the Patient ID option was chosen as either Optional or Required when the meter was set up
(see Meter Setup/Patient ID), you are prompted to enter a Patient ID1. If Required, enter the Patient ID, then touch move to the next screen. If Optional, ignore the prompt and touch move to the next screen. The meter will assign the test a consecutive number. If neither option was chosen, a screen appears that prompts you to insert a test strip. Continue with Step 9. to to 3 4
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A F K P U Z Patient ID 09:15 am E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan l 4 e p m a S d o o B a l 1. For configuring operator and patient IDs, see page 145. g n i t s e T 104 With patient list Test 09:15 am PID01 Smith, Henry PID02 Jones, Walther PID03 Hamilton, Fran PID04 Miller, Ted PID05 Reed, William New Scan 05/29/2015
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A F K P U Z Patient ID 09:15 am E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan 5 6 7 and to display the entry of choice. Touch Patient Test. Touch Select the patient to be tested from the list. If the patient is not in the list, touch New to create a new entry. You must now enter a Patient ID using the keypad. Note: Extended data handling functionality and patient ID entry options are dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. For more details see Data han-
dling, starting on page 139. 105 Alternatively, the Patient ID can also be entered using the built-in barcode scanner1. Touch Scan and scan the patient barcode from a distance of approx. 10-20 cm
(4-8 inches), according to the barcode size. The meter beeps once the barcode has been read suc-
cessfully. The barcode information appears in the patient ID field. The scanner turns off after 10 seconds, if a bar-
code is not scanned. l 4 e p m a S d o o B a l 1. A list of supported barcode symbologies can be found in Appendix A.2 on page 166, a list of supported characters in Appendix A.3 on page 169. g n i t s e T 106 Test 09:15 am PT aPTT Test P-ID: PID01 Mller, David Schulz PT Op:
Par:
05/29/2015 If the Parameter Selection option is enabled in the meter settings, you are now prompted to select the parameter to be tested. The testing procedure for both parameters is similar. For illustration purposes testing with PT test strips is shown as an example. 09:15 am 05/29/2015 8 9 Touch the button to select the parameter you want to use. The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error mes-
sages. Therefore, always close the strip container immediately after removing a test strip. 10 11 Hold the test strip so the lettering with the test name is facing upward. Slide the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep indicates that the meter has detected the test strip (provided the beeper is enabled). Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT 184 05/29/2015 09:15 am 09:15 am Test P-ID: PID01 Smith, Henry Operator 1 PT Op:
Par:
Code: 184 05/29/2015 09:15 am Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 3:00 Min. 05/29/2015 107 If you use a new test strip lot and have not inserted the code chip yet, you must do so now. Otherwise you cannot perform a test. The meter displays the number of the code chip belonging to the new test strip lot. Depending on the setting, you may also be required to run a liquid quality control test at this point. The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply blood. The blood drop icon flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied. A countdown begins. You must apply the drop of blood to the test strip before the countdown ends. Otherwise you will receive an error message. When the test is running, no operator action is required. The display dims to save energy. l 4 e p m a S d o o B a l g n i t s e T 108 Applying blood from the fingertip WARNING Use only a lancing device that is approved for use by healthcare professionals, such as the Accu-Chek Safe-T-Pro or Safe-T-Pro Plus lancing devices, or the CoaguChek Lancets (professional-use lancets available only in the United States). Follow the manufacturers instructions. 12 Now lance the side of a fingertip with the lancing device. We recommend obtaining the capillary blood from the side of the fingertip as this causes the least pain. Massage the lanced finger gently until a drop of blood is formed. Do not press or squeeze the finger. Apply the first drop of blood from the finger. 13 Apply the blood directly from the finger to the semicircular, transparent sample application area on top of the test strip. or you can touch the blood drop against the side of the sample application area. The test strip draws up the blood by capillary action. During this process you must hold the blood drop to the test strip until the flashing blood drop icon has disappeared and the meter beeps (provided the beeper is enabled). you can also apply the blood using the optional CoaguChek capillary tube. Apply the blood drop to the test strip within 15 seconds of lancing the fingertip. Applying blood after this period of time may lead to an erroneous result (as the coagula-
tion process would already have started). When applied from above, the blood must cover the entire sample application area. Applying blood with a syringe 109 Discard the first four drops of blood collected (within the first 10 seconds). Then immediately apply one drop of blood (at least 8 L, but not more than 20 L) directly onto the target area of the test strip. Ensure that no air bubbles are introduced into the sample. If too much blood has been applied (> 20 L) the exterior of the meter and the test strip guide should be cleaned and disinfected. For additional information on sample collection see page 96. l 4 e p m a S d o o B a l g n i t s e T 110 09:15 am Test P-ID: PID01 Smith, Henry Operator 1 PT Op:
Par:
Code: 184 You hear a beep tone when you have applied enough blood (provided the Beeper is enabled). The blood drop symbol disappears and the test starts. Do not add more blood. To avoid error messages do not touch the test strip until the result is displayed. 05/29/2015 09:15 am Test P-ID: PID01 Smith, Henry Operator 1 PT Op:
Par:
Code: 184 QC Test P-ID: PID01 Op:
Par:
05/29/2015 Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am 2.5INR 21%Q Test P-ID: PID01 09:15 am Op:
Par:
05/29/2015 Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am INR
> 8.0 05/29/2015 The meter performs an automatic quality control test on the test strip before it displays the test result. QC appears in the display. 09:15 am Following a successful outcome of the quality control test, a checkmark appears after QC. The result is displayed in the unit you chose when setting up the meter. It is automatically saved. For information on the valid measuring ranges for CoaguChek PT test strips and for CoaguChek aPTT test strips refer to the package insert of the respective test strip. Results that are above or below the measuring range are indicated by the symbols > (above) or < (below). Test P-ID: PID05 09:15 am Op:
Par:
Mller, David Schulz PT Code: 208 05/29/2015 09:14 am 1.6INR C 05/29/2015 Test P-ID: PID05 09:15 am Op:
Par:
Mller, David Schulz PT Code: 208 05/29/2015 09:14 am 1.6INR C 05/29/2015 111 If a C is displayed along with the result:
This may occur if the hematocrit value is very low or due to erroneous blood collection (e.g., wet hands). Repeat the test. If using capillary blood, make sure that the patient's hands are dry. If the message persists, perform a hematocrit check. This may occur if the test result is out of normal range. If a * is displayed along with the result:
Touch the * icon to display the Out Of Normal Range information screen. When interpreting results, refer to the detailed informa-
tion on limitations and interferences included in the limi-
tations section of the test strip package insert. l 4 e p m a S d o o B a l g n i t s e T 112 Accepting or rejecting a test result If this function is enabled, you may choose to accept or reject a test result. When the result is displayed, touch 09:15 am Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am 2.5INR 21%Q Measurement Result OK?
Reject Accept 05/29/2015 Comment Required I-009 A comment is required if you reject a result. Please enter a comment. Reject or Accept If you reject a result, you must enter a comment with an explanation. If you reject the result, this test result is no longer dis-
played. However, the test entry is stored. 09:15 am Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am Rejected Will Repeat Test 05/29/2015 Adding comments 09:15 am Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am 2.5INR 21%Q 05/29/2015 Comment 09:15 am Asymptomatic Cleaned Meter Doctor Noti ed Sick Custom 05/29/2015 Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am 2.5INR 21%Q Doctor Noti ed Sick Travel 05/29/2015 113 You can add up to three comments to a test result. Com-
ments can provide, for example, additional information about the test conditions or the patient. A comment may be up to 20 characters in length. You can open the func-
tion for adding comments directly in the results screen. To add comments:
If you want to add a comment, do not remove the test strip. Once the strip is removed, the meter automatically returns to Main Menu and a comment can no longer be added. 1 2 3 4 09:15 am
. In the Test screen, touch Select the desired predefined comment(s) from the display list (if configured) or Touch Custom to enter your own custom com-
ment. Use the keypad (as with login) to enter your comment. Once you have selected the desired comment(s), touch to return to the results screen. The printer icon only appears if the printer function is activated. Otherwise it is not displayed. Test results are also saved when the meter is powered off in the results screen or automatically powers off. l 4 e p m a S d o o B a l g n i t s e T 114 Displaying the test result as QR code 09:15 am Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/29/2015 11:31 am 2.5INR 21%Q Test 09:15 am Doctor Noti ed Sick NEW MEDICATION 05/29/2015 05/29/2015 Finishing the test Remove 09:15 am 05/29/2015 The QR code icon only appears if the QR code dis-
play function is activated (see page 64 and following). Otherwise it is not displayed. 1 2 Touch Touch to display the result as QR code. to return to the standard result display. The size of the QR code displayed on the screen varies according to the amount of data encoded. After the test result is displayed, touch prompted to remove the strip. You will be 1 2 3 Remove the test strip from the meter. Power the meter off. Clean the meter if necessary (see Chapter 8, Main-
tenance and Care). Protection against infection:
When collecting samples always observe the general precautions and guidelines relating to blood sampling
(see page 17). Dispose of all test strips used for patient testing in accordance with the disposal policy of your laboratory or practice (see page 17). 115 STAT tests STAT tests are a limited number of tests that can be per-
formed in emergency situations, see page 88. If the meter is configured to perform STAT tests, you have the option of performing a test by choosing STAT even though a QC Lockout is in place. Main Menu 09:15 am Test 09:15 am Test 09:15 am QC!
Patient Test Control Test Review Results Setup Logout QC status PT aPTT
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3 Locked PT aPTT STAT Info I-011 3 STAT tests remaining before lockout. 05/29/2015 05/29/2015 05/29/2015 09:15 am Test P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 184 05/29/2015 09:14 am 2.5INR 21%Q STAT Test 05/29/2015 1 2 3 4 To perform the measurement without performing a quality control test, touch Patient Test:
Touch the button to select the parameter you want to use. Touch STAT tests. Perform the test. to confirm the number of remaining When a STAT test is performed, this information is stored with the result. The number of STAT tests allowed is reduced by 1. After all pending quality control tests are performed, the specified number of STAT tests is availa-
ble again in case of a new lockout. The default setting is three for the number of STAT tests allowed when in QC Lockout. l 4 e p m a S d o o B a l g n i t s e T 116 This page intentionally left blank. 5 Control and Proficiency Testing 5.1 Control testing The CoaguChek Pro II meter has a number of built-in quality control functions. A check of the electronic components and func-
tions 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 carried out by the code chip. An onboard quality control within every single test strip. Roche Diagnostics offers liquid quality controls for the CoaguChek Pro II system. These controls are designed to assist you in meeting regulatory compliance require-
ments at your facility. To perform an optional liquid quality control test using control solutions, you need:
CoaguChek Pro II meter The test strip code chip supplied with the test strip container you are using (a code chip is provided with every test strip pack). Test strips that came with the code chip mentioned above Bottles of CoaguChek PT Controls, CoaguChek aPTT Controls, diluent droppers, and the quality control code chip provided. You can choose the frequency of liquid quality control tests in the meter setup. (Refer to the chapter entitled Meter Setup/QC (quality control) Lockout starting on page 83). If the control results in the display are in the specified range, this confirms that the liquid control test was performed correctly. 117 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 118 5.2 Preparing to perform a liquid quality control test Prepare for a liquid quality control test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of control solution instead of blood. 1 Have the test strip container at hand. 2 If you are using the test strip lot for the first time, make sure that the code chip that came with these test strips is at hand. 3 Make sure the bottle of freeze-dried (lyophilized) con-
trol plasma and the dropper for making the control solution are at hand. This bottle should remain refrig-
erated (not frozen) until use. 4 Make sure that the quality control code chip that came with the control solution is at hand. 5 Open the lid of the bottle and remove the rubber cap. 6 Hold the dropper with the sealed dropper neck point-
ing upward, then cut off the end of the cap with scis-
sors. Do not hold the dropper close to your face. To avoid loss of diluent, hold the dropper by the stem;
do not squeeze the bulb of the dropper while cutting the tip. 7 8 9 10 Apply gentle pressure to the reservoir to transfer the entire contents of the dropper to the bottle. Make sure that the dropper does not come into contact with the dried control plasma. Close the bottle again. Make sure the dropper is at hand for the next steps in the liquid quality control test. Swirl the bottle using a circular motion to com-
pletely dissolve all of the control plasma inside. Do not shake the bottle or turn it on its side. Doing so can cause components in the control plasma to stick to the sides of the bottle. Please refer to the control solution package insert. The control solution is now ready to be applied to the test strip. The control solutions may be reconstituted (mixed) after removal from the refrigerator. For further information refer to the respective package insert(s). 119 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 120 5.3 Performing a liquid quality control test 1 Place the meter on a level, vibration-free surface or hold it in your hand so it is roughly horizontal. Power the meter on by pressing 2 You can also power on the meter directly by inserting a test strip or connecting the power adapter. 3 4 Wait until the Main Menu is displayed, or log on as described on page 100. Check the battery level. If the battery icon turns red (one bar left), there may not be enough power left for another test. If there are no bars left in the battery icon, you cannot perform any more tests. Power the meter off by pressing
. In both cases, restore power by recharging the battery pack, or using the power adapter. 5 Check that the date and time are correct. Correct any wrong entries as described in Chapter 3, Meter Setup/Setting the date. Main Menu 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 Main Menu 09:15 am QC Test 09:15 am QC Test 09:15 am QC Test 09:15 am Control Test Pro ciency Test PT aPTT Op:
Schulz Par:
PT Patient Test Control Test Review Results Setup 05/29/2015 05/29/2015 05/29/2015 05/29/2015 6 7 8 9 Touch Control Test. In the QC Test menu, touch Control Test again. Touch the button to select the parameter you want to use. The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error mes-
sages. Therefore, always close the container immedi-
ately after removing a test strip. 10 11 Hold the test strip so the lettering with the test name is facing upward. Insert the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep indicates that the meter has detected the test strip (provided the beeper is enabled). 121 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 122 QC Test 09:15 am QC Test 09:15 am Op:
Operator 1 184 New Code QC 070 QC 060 QC 050 QC 048 05/29/2015 Scan 05/29/2015 If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. Other-
wise you cannot perform a quality control test. As with the test strips, a quality control code chip is also provided with the control solutions. This chip informs the meter about the acceptable ranges of results for that lot of controls. The information on the code chip is retained in the memory so you can use the same control solutions at any time. 12 Select the code stored for your current control solution or touch New Code to use a new control solution. When entering or selecting a code manually, make sure it matches the code printed on the bottle of the control solution. Alternatively, the control solution code can also be entered using the built-in barcode scanner. Touch Scan and scan the barcode on the label from a distance of approx. 10 cm (4 inches). The meter beeps once the barcode has been read suc-
cessfully. The barcode information appears in the code field. The scanner turns off after 10 seconds, if a barcode is not scanned. QC Test 09:15 am Code: 184 Op:
Operator 1 Par:
PT QC 05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Par:
PT Level 1 Level 2 05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 1 Par:
PT 05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 1 Par:
PT 3:00 Min. 05/29/2015 If you are using a new control solution, remove the strip code chip from the meter and insert the code chip that came with the control solution instead. If the code chips get mixed up, check the letter on the code chips to tell them apart. A capital S in front of the number indicates that this code chip is for test strips. A capital C in front of the number indicates that it is a control solution code chip. 13 If performing more than one level, select the level for this measurement. The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply the control solution. The dropper icon flashes to indicate that the meter is ready to perform the test and is waiting for the sample to be applied. At the same time a countdown begins. You must apply the sample within the displayed time, otherwise you will receive an error message. 123 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 124 14 15 Using the dropper, draw up the dissolved contents of the bottle. Apply a single drop of control solution directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more control solution. You hear a beep when you have applied enough control solution (provided the beeper is enabled). The dropper icon disappears and the test starts. The result of the liquid quality control test is displayed. It is automatically saved to memory. The acceptable range of results for the liquid control is displayed below the current result, along with Pass or Fail. If a quality control test fails, an up arrow (too high) or down arrow (too low) is displayed and flashes. Note: The arrow (next to the result) refers to the INR result only. If you have selected to display INR and %Quick or INR and seconds, the (up or down) arrow next to the result refers only to the INR value. The printer icon only appears if the printer function is activated. Otherwise it is not displayed. Regardless of the Result Units settings chosen for PT, aPTT is always displayed in seconds (see page 50). QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 1 Par:
PT 05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 1 Par:
PT Pass:
05/29/2015 09:15 am 1.2 INR
(1.0 - 1.4 INR) 78 %Q
(53 - 99 %Q) 05/29/2015 QC Test QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 1 Par:
PT Fail 05/29/2015 09:15 am 0.9 INR
(1.0 - 1.4 INR) 110 %Q
(53 - 99 %Q) 05/29/2015 125 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 126 QC Comment 09:15 am Acceptable Cntrl. Cleaned Meter Doctor Noti ed New Control Lot Custom 05/29/2015 Remove 09:15 am 05/29/2015 16 17 18 19
. If you want to add a comment, touch Select the desired predefined comment(s) from the pick list (if configured) or Touch Custom to enter your own custom com-
ment. Use the keypad (as with login) to enter your comment. A comment may be up to 20 characters in length. Once you have selected the desired comment(s), touch to return to the results screen. After the test result is displayed, touch prompted to remove the strip. You will be 20 Remove the test strip from the meter. If you are performing a 2-level control, you will now be asked to proceed with the second level. 21 22 23 Power the meter off. Remove the quality control code chip from the meter and store it with the controls. Clean the meter if necessary (see Chapter 8, Maintenance and Care). Dispose of controls and used test strips from control test-
ing in accordance with the disposal policy of your facility. The control solution contains animal material, which should be considered as potentially infectious. 5.4 Proficiency testing Observe the applicable regulations and directives of the responsible regulatory agencies when performing profi-
ciency tests. Proficiency tests are performed on samples whose values are unknown to the operator performing the test. These samples are provided by an external source, and the results should be forwarded to the appropriate source after completing the test. The samples supplied are treated in the same manner as regular patient samples. Proficiency testing provides another means of verifying that your technique, reagents, system, and testing performance are as they should be. Some regulatory agencies require that these proficiency samples be tested as part of an institution's quality assurance program before an institution can be certified. When using a data management system for configura-
tion, it is possible to partially or fully disable the func-
tions described in this chapter. In this case, the corresponding selection screen does not appear (after you touch Control Test). 127 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 128 5.5 Preparing to perform a proficiency test You prepare for a proficiency test in the same way you would prepare to perform a test with a capillary blood sample. The only difference is the use of the proficiency sample supplied instead of blood from a patient. To perform a proficiency test you need the following:
The information of at least one code chip for test strips must be stored in the meter and must match the lot number of the test strips used. The correct test strips must be available. The proficiency sample must be available. If you are using the test strip lot for the first time, make sure that the code chip supplied with these test strips is at hand. 5.6 Performing a proficiency test 1 Place the meter on a level, vibration-free surface or hold it in your hand so it is roughly horizontal. Power the meter on by pressing 2 You can also power the meter on directly by inserting a test strip or connecting the power adapter. 3 4 Wait until the Main Menu is displayed, or log on as described on page 100. Check the battery level. If the battery icon turns red (one bar remaining), there may not be enough power available for another test. If there are no bars remaining in the battery icon, you cannot perform any more tests. Power the meter off by pressing
. In both cases, restore power by recharging the battery pack or using the power adapter. 5 Check that the date and time are correct. Correct any wrong entries as described in Chapter 3, Meter Setup/Setting the date. Main Menu 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 129 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 130 Main Menu 09:15 am QC Test 09:15 am Pro ciency 09:15 am Patient Test Control Test Review Results Setup Control Test Pro ciency Test 05/29/2015 05/29/2015 05/29/2015 Touch Control Test. Touch Proficiency Test. 6 7 For proficiency testing, the test parameter information is read from the test strip. 8 The test strip icon prompts you to insert a test strip. Remove a test strip from its container and close the container again with the stopper. Exposure to external influences (such as humidity) may deteriorate the test strips and may lead to error mes-
sages. Therefore, always close the container immedi-
ately after removing a test strip. 9 10 Hold the test strip so the lettering with the test name is facing upward. Slide the test strip into the test strip guide in the direction indicated by the arrows. Slide the test strip in as far as it will go. A beep indicates that the meter has detected the test strip (provided the beeper is enabled). Sample ID 09:15 am 202|
A F K P U Z E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan Pro ciency 09:15 am QC:
202 Code: 101 Par:
aPTT Pro ciency 09:15 am QC:
202 Code: 101 Par:
aPTT 1:35 Min. 05/29/2015 05/29/2015 Enter or scan the sample ID. 11 The hourglass icon shows that the test strip is warming up. When the warming-up process is complete, a further beep (provided the beeper is enabled) indicates that you can now apply the proficiency sample. The dropper icon flashes to indicate that the meter is ready to perform the test and is waiting for the sample to be applied. A countdown begins at the same time. You must apply the sample within the displayed time or an error message will be displayed. 131 5 g n i t s e T y c n e c i f o r P i d n a l o r t n o C 132 Pro ciency 09:15 am QC:
202 Code: 101 Par:
aPTT Pro ciency 09:15 am QC:
202 Code: 101 Par:
aPTT 06/03/2015 11:30 am 51.6 SEC Pro ciency 05/29/2015 05/29/2015 12 Apply a single drop of the sample directly from the dropper to the semicircular, transparent sample application area on top of the test strip. Do not add more of the sample. You hear a beep when you have applied enough of the sample (provided the beeper is enabled). The dropper icon disappears and the test starts. The result of the proficiency test is displayed, the com-
ment Proficiency is automatically added. If you want to add further comments, touch matically saved to memory. The test result is auto-
After the test result is displayed, touch prompted to remove the strip. You will be 13 14 15 Remove the test strip from the meter. Power the meter off. Clean the meter if this becomes necessary (see Chapter 8, Maintenance and Care). Dispose of used test strips from proficiency testing in accordance with the disposal policy of your facility. 6 Review Results (Memory) The CoaguChek Pro II meter can save 2000 patient test results as well as 500 liquid quality control tests to mem-
ory, together with respective time and date. In addition, up to 120 code chip records (contents of 60 test strip code chips and 60 control solution code chips) are stored. If you are using operator and/or patient lists, a maximum of 5000 Operator and 4000 Patient IDs is allowed. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved. This applies both to patient results and to quality control tests. In order to avoid the loss of stored test results, you can archive this data using a data man-
agement system and the optional Handheld Base Unit
(see page 139). 133 6
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s t l u s e R w e i v e R 134 6.1 Viewing test results 1 2 3 Place the meter on a level, vibration-free surface, or hold it in your hand so it is roughly horizontal. Power the meter on by pressing
. Wait until the main menu is displayed. Main Menu 09:15 am Patient Test Control Test Review Results Setup 05/29/2015 Main Menu 09:15 am Memory 09:15 am Memory 09:15 am Patient Test Control Test Review Results Setup Patient Result QC Result All results PT aPTT 05/29/2015 05/29/2015 05/29/2015 4 5 6 Touch Review Results. Select the type of results you want to view. Display Patient Result memory Display QC Result memory Select the test parameter(s) you want to view. For displaying patient results:
Parameter selection is only available, if the sort order has been set to Date/Time (see page 58). If the sort order has been set to Patient ID or Patient Name the patient result screen is shown directly. The following buttons for general use are located in the views described below:
Menu icon: Return to main menu Return icon: From the single-result display, return to the list of results Individual icon: List that contains entries for this patient only Printer icon: The printer icon only appears if the printer function is activated. Otherwise it is not displayed. QR Code icon: The QR code icon only appears if the QR code display is activated. Otherwise it is not displayed. 135 6
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s t l u s e R w e i v e R 136 Display patient result memory This memory area contains all patient test results. They are sorted according to the order you defined for the option Sort (see page 58). If the Sort option is set to Date/
Time they are filtered by means of the test parameter you previously selected, the most recent results are at the top of the list. Memory PID01 05/28/2015 11:31 am PID02 05/27/2015 10:10 am PID01 05/26/2015 10:15 am PID01 05/25/2015 09:58 am PID03 05/24/2015 10:03 am 09:15 am Memory 09:15 am P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 250 05/28/2015 11:31 am 2.5INR 21%Q Doctor Noti ed Sick New Strip Lot Memory 09:15 am P-ID: PID01 Smith, Henry 05/28/2015 11:31 am 2.5 INR 21 %Q 05/26/2015 10:15 am 3.0 INR 16 %Q 05/25/2015 09:58 am 1.7 INR 38 %Q 05/29/2015 05/29/2015 05/29/2015 to scroll to the entry of choice on 1 and Touch the screen. Touch the entry you want to open. 2 The entry is displayed. 3 Touch displayed. The results for the selected patient are If you choose to display patient-related lists, you cannot filter a list by test parameters. The QR code icon only appears if the QR code dis-
play function is activated. Otherwise it is not displayed. 4 5 Touch Touch to display the result as QR code. to return to the standard result display. Memory 09:15 am P-ID: PID01 Op:
Par:
Smith, Henry Operator 1 PT Code: 250 05/28/2015 11:31 am 2.5INR 21%Q Memory 09:15 am Doctor Noti ed Sick New Strip Lot 05/29/2015 05/29/2015 Display QC (quality control) result memory This memory area contains all liquid quality control tests that were run, sorted chronologically. The most recent results are at the top of the list. QC 09:15 am 05/28/2015 11:31 am QC 999 Pass 05/27/2015 10:05 am QC 234 Pass 05/26/2015 10:07 am QC 623 Pass 05/25/2015 10:30 am QC 333 Pass 05/24/2015 11:01 am QC 432 Pass 05/29/2015 1 2 Memory QC:
999 Code: 184 Op:
Operator 1 09:15 am Level: 1 Par:
PT Pass:
05/28/2015 11:31 am 1.2 INR
(1.0 - 1.4 INR) 78 %Q
(53 - 99 %Q) New Control Lot New Strip Lot 05/29/2015 to scroll to the entry of choice on and Touch the screen. Touch the entry you want to open. The entry is displayed. 137 6
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s t l u s e R w e i v e R 138 This page intentionally left blank. 7 Extended Functionalities 7.1 Data handling Note: Extended data handling functionality is depend-
ent on the capabilities of the particular Data Manage-
ment System (DMS) being used and may vary. When used in conjunction with the Handheld Base Unit from Roche Diagnostics (available separately), the CoaguChek Pro II meter can conveniently connect to a data management system (DMS). The main advantages of such a connection between meter and DMS may include:
Transferring patient lists, operator lists, and settings from the DMS to the meter. In this way the setup for daily work as well as general meter setup can be performed (for one or more meters) quickly and conveniently. Transferring all stored test results with the corre-
sponding Patient ID, Operator ID, and comments from the meter to the DMS. This transfer of data permits further evaluation or proper archiving according to your needs. 139 7 s e i t i l a n o i t c n u F d e d n e t x E 140 Through the DMS the system administrator (such as the POC coordinator) may specify what settings are to be applied to a set of meters within a site or unit (e.g., hospi-
tals or wards). All meters assigned to a specific site and/
or unit would consequently share the same settings. The different operator and patient lists (that match a site or unit) are then made available on their respective meters. Other settings such as QC Lockout and Operator Lockout may easily be set (once) and distributed to all meters. The option of setting up an Operator Lockout is availa-
ble only when operator lists are created on the DMS, stored in the meter, and Operator login is activated. For more details on Operator login see page 76, for details on Operator Lockout see page 86. Computer (Setup option) For initial connection to a DMS, the ability to communi-
cate within a network has to be set up as follows:
In the Setup Menu, the Connection option must be set to Computer (see page 63). The Handheld Base Unit must be configured cor-
rectly. (For details please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself.) Place the meter on a Handheld Base Unit that is connected to the network. The meter will automat-
ically be recognized by the DMS and may now be assigned to a site and/or unit managed by the DMS
(if your DMS has that functionality). Depending on DMS functionality available, the DMS may transfer settings and lists to the meter as well as enable test results to be transferred from the meter to the DMS. 141 7 s e i t i l a n o i t c n u F d e d n e t x E 142 Operator lists After powering the meter on, an Operator login may be configured. There are four possible configurations for an Operator login:
Operator is activated, but there is no list available:
The Operator can either log in via the onscreen keypad or a barcode scan. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are entered via the onscreen keypad or read from the barcode and stored with test results for informational purposes only. This first configuration is also available without a DMS. Operator is activated, there is no list available and the List feature is set to hidden (only possible with a DMS). Setting the "List" feature to "hidden"
with the DMS automatically blocks the display of the meter's onscreen keypad as well. The Operator can only log in via a barcode scan as there is no onscreen keypad. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are read from the barcode and stored with test results for informational purposes only. Meters which are managed by a DMS may receive an Operator list. Operator is activated, a list is available and dis-
played on the login screen:
The Operator selects the ID from the displayed list. If so configured by the Administrator, the Operator may also be required to enter a password to log in. Operator is activated, a list is available but set to hidden:
The Operator can login via a barcode scan. If so configured by the Administrator, the Operator may also be required to enter a password to log in. When working with operator lists: The use of the meter is restricted to the operators on this list. Patient lists When starting a Patient Test, there will be the option of either selecting a Patient ID from a patient list, entering the Patient ID using the onscreen keypad or, if available, of scanning the barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional iden-
tification entry. Up to 20 characters can be used and assigned as a second confirmation (e.g., name, date of birth). There are four possible configurations for a Patient ID input:
The Patient ID is set to Optional or Required, and there is no list available:
A Patient ID can be entered manually via the onscreen keypad or read in via a barcode scan. The Patient ID is stored with the test result. The Patient ID is set to No, but there is a list available:
The list of Patient IDs is always shown when starting a test. You may now select a patient from the list;
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. Instead of an ID a consecutive number will be assigned to this result. 143 7 s e i t i l a n o i t c n u F d e d n e t x E 144 Patient list validation The Patient ID is set to Optional or Required, and there is a list available:
The list of Patient IDs is always shown when start-
ing a measurement. You may now:
select a patient from the list;
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. You may either read the ID using the barcode scanner or enter a new ID via the onscreen keypad. The Patient ID is set to hidden (only possible with a data management system), and there is a list available:
When you start the test, the screen is blank and Scan is displayed. You may now scan a Patient ID using the barcode scanner. If the patient ID is on the list, the test will proceed. If the patient ID is not on the list, you will get an error message. Note that the scanned Patient ID must already be on the list that is sent from the DMS to the meter. You cannot use the scanner to scan and enter a new Patient ID if the Patient ID is set to hidden. Depending on DMS settings, you have the following options for patient list validation when working with Patient lists:
A Patient ID does not have to be on the list to be used (only valid for validation mode off). The meter displays a warning if the Patient ID entered is not on the list. The meter displays an error message if the ID was not found on the list of valid Patient IDs. To proceed with the test, you must scan ( if ID set to hid-
den) or select ( if ID set to Required) a valid Patient ID. Configuring operator and patient IDs When creating operator and patient IDs, apply the follow-
ing rules:
Patient IDs can consist of up to 20 alphanumeric characters, with specified minimum and maximum lengths. Operator IDs can consist of up to 20 alphanumeric characters. Alphanumeric characters are any combination of A - Z and 0 - 9, additionally . (period), or - (hyphen) may be used. Using a DMS, the barcode scanner may be configured to accept only selected barcode symbologies. A list of sup-
ported barcode symbologies can be found in Appendix A on page 166, a list of supported characters in Appendix A.3 on page 169. Barcode masking can be used to eliminate any charac-
ters not belonging to the Operator ID. See information on Operator and patient ID barcode masks on page 165. When performing a test, the test result will be stored along with additional information, including the Patient ID, Operator ID, the kind of test performed, and optional Comments. The meter comes with a default set of Com-
ments that can be assigned to each test result. If you are working with a DMS, these comments can be replaced by the comments in the DMS. The new wording will then be available for selection from the Comments list in the meter. Up to 3 comments can be assigned to each result. Barcode scanner Stored test results and comments 145 7 s e i t i l a n o i t c n u F d e d n e t x E 146 The default preset comments in the meter are:
Patient result comments QC result comments Asymptomatic Cleaned Meter Doctor Notified Sick Travel Lab Draw No Action Procedure Error Under Medication Will Repeat Test Changed Dosing Acceptable Control Cleaned Meter Doctor Notified New Control Lot New Lot Number New Strip Lot New Strip/Kit Lot No Action Procedure Error Proficiency Test Repeat Control Test RN Notified Switched QC Vial Will Repeat Test For more information and technical details, please refer to the manual of the Handheld Base Unit and the Tech-
nical Note stored on the Handheld Base Unit itself. 147 8 Maintenance and Care 8.1 Conditions for storage and shipping Storage Store the system and test strips in the same envi-
ronment in which they are used. Do not store the meter in direct sunlight or under extreme temperature conditions. Observe the limits for temperature and humidity when storing and using the meter (see Chapter 10). 8 e r a C d n a e c n a n e t n a M i 148 Shipping Observe the following safety information when shipping the meter and battery pack. Failure to do so may result in injury to persons or damage to the meter or battery pack. If the meter is shipped or transported over long dis-
tances, always remove the battery pack from the meter. This eliminates the possibility of the battery pack overheating due to a short-circuit in the meter. It also prevents deep discharge and other damage to the battery pack or meter. Only ship undamaged battery packs. Damaged bat-
tery packs must be disposed of locally. See page 19 for the risks associated with damaged battery packs and disposal information. Package the battery pack for shipping so that it cannot move around in the packaging. Also observe any other applicable national regulations. When shipping via third parties (e.g., by air or parcel service), work with the carrier to check whether specific requirements need to be met in relation to the lithium-ion battery packs on the basis of national or international laws on hazardous goods and, where applicable, if special packaging and labeling requirements apply. For short distances - example between a facilitys sites
- users may transport the battery packs (either installed in the meter or separately) by road without having to meet further requirements. 149 8.2 Cleaning and disinfecting the meter Difference between cleaning and disinfecting Cleaning is the physical removal of organic soiling (e.g., dirt, or other foreign material) from the meter surface. When should the meter be cleaned and disinfected?
What to clean and disinfect?
Disinfecting is the removal of most, but not all, disease-
causing and other types of microorganisms (blood-borne pathogens) from the meter. Clean the meter to remove visible soil and organic material for safe handling and/or prior to disinfecting. The exterior of the meter and the test strip guide should be cleaned and disinfected before being used on another patient. The exterior of the meter and the test strip guide should be cleaned and disinfected if too much blood (> 20 L) has been applied. Maintenance cleaning: The use of the disinfecting cloths may lead to a build-up of residue on the test strip guide and battery compartment that needs to be removed. Frequency: whenever residue build-up is visible or at least once per month. Disinfect the meter when it is soiled and per your facilitys guidelines. The following parts of the meter may be cleaned /
disinfected:
The area around the test strip guide The meter display (touchscreen) The meter housing (entire meter surface - front and back) The test strip guide and test strip guide cover 8 e r a C d n a e c n a n e t n a M i 150 NOTICE Observe the disinfection guidelines of your institution. Use gloves. Follow the instructions given below to clean and disinfect the meter. Failure to follow these instructions may cause malfunction of the meter. Instrument damage due to moisture Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. Make sure the meter is turned off. Do not spray anything onto the meter housing. Do not spray into the test strip guide. Do not immerse the meter in liquid. Do not use cloths or swabs/buds that are saturated. Squeeze off excess solution or blot on a dry paper towel to remove any excess solution before wiping the surface of the meter. 8.3 Recommended cleaning/disinfecting agents 151 Use only the following solutions for cleaning/disinfecting the meter (housing and test strip guide). A soft cloth slightly dampened (not wet) with a small amount of liquid soap diluted in water Rubbing alcohol (70% ethanol or isopropyl alcohol) Alcohol-based disinfectant (a mixture of 1-propanol (400mg/g), 2-propanol (200 mg/g) and glutaraldehyde (1.0 mg/g)) 1 10% sodium hypochlorite solution (1 part bleach to 9 parts de-ionized water, made fresh every 24 hours) Disposable wipes containing quaternary ammo-
nium compounds up to 0.5 % (single compound or mixture) in isopropyl alcohol (isopropanol) up to 55 %
NOTICE Do not use any other disinfectants/cleaning solutions on the meter (housing or test strip guide). Use of other dis-
infectants/cleaning solutions could result in damage to the meter. 8 e r a C d n a e c n a n e t n a M i 1. Sold in some countries under the name Bacillol Plus. 152 8.4 Cleaning/disinfecting the exterior (meter housing) Use the solutions recommended on page 151 for clean-
ing/disinfecting the meter exterior. Apply the solutions for a contact time of > 1 minute (refer to the corresponding product labeling). Ensure that the blue test strip guide cover remains tightly closed while cleaning the meter housing. 1 Power off the meter. Then gently wipe over the sur-
faces (touchscreen, housing) with a soft, lint-free cloth slightly dampened (not wet). Do not let liquid accumulate near any opening. Ensure that no liquid enters the meter. 2 3 With a fresh dry cloth or lint-free tissue, wipe away residual moisture and fluids after cleaning the housing. Visually verify that no solution is seen any-
where on the housing or touchscreen at the com-
pletion of cleaning and disinfecting. Allow wiped areas to dry for at least 10 minutes before performing the next patient test. If you notice streaks on the housing or touchscreen, or the touchscreen surface becomes slightly cloudy, wipe clean immediately with a soft, lint-free cloth slightly dampened with water. 8.5 Cleaning/disinfecting the test strip guide 153 Use the solutions recommended on page 151 for clean-
ing/disinfecting the test strip guide. Apply the solutions for a contact time of > 1 minute (refer to the correspond-
ing product labeling) using lint-free cotton swabs/buds. 1 2 With the meter powered off, remove the test strip guide cover to clean it. (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 warm water or wipe it clean using the solutions recommended above. Let the test strip guide cover dry for at least 10 minutes before re-attaching it. Hold the meter upright with the test strip guide facing down. Clean the easily accessible white areas with a mois-
tened cotton swab/bud. Ensure the swab/bud is only damp, not wet. Wipe away residual moisture and fluids. 8 e r a C d n a e c n a n e t n a M i 154 NOTICE Damage to the instrument Ensure that no liquid enters the meter when clean-
ing the test strip guide. If moisture enters the meter, it may cause malfunction of the instrument. Do not insert any objects in the test strip guide. Doing so may damage the electrical contacts behind the test strip guide. On completion of cleaning:
3 4 With the cover off, let the test strip guide dry for at least 10 minutes before re-attaching the test strip guide cover and testing again. Visually verify that no residual moisture is seen any-
where on the test strip guide and cover at the com-
pletion of cleaning and disinfecting. Ensure that the test strip guide and cover are com-
pletely dry before assembling them. Re-attach the test strip guide cover to the housing. Make sure that the cover is properly closed. You will hear it snap into place. 8.6 Cleaning the scanner window The scanner window should be cleaned periodically. Use a clean, dry cloth to wipe the scanner window. 9 Troubleshooting Message I-001: Battery Low Battery Low I-001 The battery is getting low. Replace or recharge battery pack as soon as possible. The CoaguChek Pro II meter continually checks its sys-
tems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These messages are marked with an icon, either for an error message. All messages displayed by the system are accompanied by a description of the error and a pos-
sible solution. for a status message, or Take the action suggested on screen to resolve the prob-
lem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche Diagnostics (see page 163). The two different message types are illustrated below:
Description Status message Touch to proceed with the next step. E-101: Patient ID Required Patient ID Required E-101 A patient ID is required. Enter a valid patient ID. Error message Touch step(s) to solve the problem. to exit this message. Perform the suggested 155 9 g n i t o o h s e b u o r T l 156 E-406: Sample Error Sample Error E-406 Unsuitable sample composition. Check your procedure and repeat the test with a fresh sample. Check medication regimen of patient. Additional information on error E-406 Error message Touch step(s) to solve the problem. to exit this message. Perform the suggested Power the meter off and remove the test strip. Repeat the measurement using a new test strip and blood taken from a new puncture site at the tip of another finger. Do not touch or remove the test strip when a test is in progress. Note on error E-406: The CoaguChek PT Test strip may be used for patients under a combination therapy of oral anticoagulants plus heparin injections. For maximum heparin concentrations which do not interfere with the test, refer to the package insert. Under no circumstances, however, should heparinized capillary tubes be used for sample application. If capillary tubes are used, use only the dedicated CoaguChek capillary tubes. Be sure to apply the blood drop to the test strip within 15 seconds of lancing the fingertip. In rare cases, patients with abnormal or unusually long clotting times may receive an E-406 message on the meter display. If this error mes-
sage appears again when the test is repeated, the result must be checked using another method. For further information on the measuring range of the parameter refer to the respective package insert. Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message. Message Description No message or unusual behavior Meter display does not power on Wait 10 seconds and try powering on the meter again. Check that the meter has power (see Installing the battery pack starting on page 38) Is the battery pack properly installed in the meter?
Does the meter power on when connecting the external power adapter?
Does the battery pack charge properly?
Meter displays an unexpected result Refer to the package insert for the test strips. Automatic shutdown The meter powers off after a configurable time without activity (e.g., pressing a key, touching the screen) to con-
serve energy. Reactivate the meter/screen as described in the following:
Shutdown after time specified by system administrator (default is 5 minutes, configurable by system administrator) Press
. 157 9 g n i t o o h s e b u o r T l 158 Meter reset A meter reset should only be performed if all other reme-
dies have failed. 1 2 3 4 Place the meter on a level surface. Press the On/Off button for at least 12 seconds. The meter powers off and on again. The Roche logo is displayed. If the Roche logo does not appear within 60 sec-
onds, place the meter in the Handheld Base Unit for a minimum of 15 minutes to recharge the battery. The meter performs a system check. The screens for entering the date and the time appear. Enter the date and time. After you have entered the correct information, confirm each screen with
. Unless all lockouts are disabled (see chapter 3.5), the meter will now be in QC Lockout due to the manually entered date/time. Synchronize the meters date/time with the date/
time of your facility via the Handheld Base Unit or, if working wirelessly, wait at least ten minutes for the next WLAN synchronization before performing any further tests. Even if your configuration does not require it, we recommend always performing a QC test after a meter reset. CoaguChek Init CoaguChek 04.00.00 Date 09:15 am Year:
2015 Time 09:15 am Month:
Day:
5 29 Hour:
Minute:
9 59 05/29/2015 AM PM 05/29/2015 10 General Product Specifications 10.1 Technical data Temperature range Relative humidity Maximum altitude Position Measuring range Memory Interface Battery operation Power connection Number of tests with a fully charged battery pack Safety class Automatic power-off Dimensions Weight Sample material Sample type Sample size Interactions
+12 C to +32 C (54 F to 90 F) 10 to 85% (no condensation) 4300 m (14,000 feet) Place the meter on a level, vibration-free surface or hold it so it is roughly horizontal. Refer to respective test strip package insert 2000 patient and 500 QC results with date and time 120 code chip records (60 strip codes and 60 control codes) Operator lists up to 5000 Operator IDs with corresponding 2nd ID (e.g., Operator Name) Patient lists up to 4000 Patient IDs with corresponding 2nd and 3rd Patient IDs (e.g., name, date of birth) Touchscreen and barcode scanner Universal Battery Pack for the CoaguChek Pro II meter Power supply adapter: Input: 100-240 V / 50-60 Hz / 350-150 mA Output: 12 V DC / 1.25 A approx. 60 tests (PT/INR) at least 20 tests (aPTT/measuring time 5 minutes) III Programmable 1 60 minutes 187 x 97 x 43 mm 280 g (without battery pack) Refer to test strip package insert Refer to test strip package insert Refer to test strip package insert 159 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 160 Storage conditions Temperature range Meter (without battery pack) Temperature range Meter (with battery pack)*
Relative humidity 25 C to +70 C (-13 F to +158 F) 10 C to +35 C (+14 F to +95 F) 10 to 85 % (no condensation)
* At temperatures above +70 C/158 F the battery pack could leak and damage the meter. At temperatures below
-10 C/+14 F the battery pack does not have enough power to keep the internal clock functioning. Transport conditions Temperature range Meter (without battery pack) Temperature range Meter (with battery pack)*
Relative humidity 25 C to +70 C (-13 F to +158 F) 10 C to +70 C (+14 F to +158 F) 10 to 85 % (no condensation)
* At temperatures above +70 C/158 F the battery pack could leak and damage the meter. At temperatures below
-10 C/+14 F the battery pack does not have enough power to keep the internal clock functioning. 10.2 Further Information Consumables / Accessories Item CoaguChek PT Test CoaguChek aPTT Test CoaguChek PT Controls CoaguChek aPTT Controls Description PT test strips for the CoaguChek Pro II meter aPTT test strips for the CoaguChek Pro II meter Optional liquid controls (Level 1, Level 2) for the CoaguChek Pro II system Remarks International edition
(not available in the US) CoaguChek Capillary Tubes/Bulbs Capillary tubes Universal Battery Pack Handheld Base Unit Kit Rechargeable battery pack Handheld Base Unit and Operators Manual Reagents and solutions Supplies are available through Roche Diagnostics. Contact your local Roche Diagnostics representative. Product limitations Please read the information in the package insert sup-
plied with the test strips and controls for detailed product data and limitations. 161 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 162 Information about software licenses This product incorporates software modules developed under open source licenses. The source code of this soft-
ware can be requested on a standard data exchange medium from the manufacturer at the following address:
Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim, Germany The General Public License (GPL) licensing conditions are available (in English only for legal reasons) as a PDF file (file name License.txt.PDF) on the CD supplied with this manual. The complete license agreements are also stored as a text file (file name License.txt) on the Hand-
held Base Unit. You can access this file by connecting the Handheld Base Unit to a PC with the USB cable. For detailed instructions on how to do this, see the Operator's Manual of the Handheld Base Unit. Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed. Repairs Contact Roche Please note that repairs and other modifications to the meter may only be performed by persons authorized by Roche Diagnostics. For all questions about the CoaguChek Pro II system that are not answered in this manual, contact your Roche Diagnostics representative. If you do not already have contact details:
Visit our website at www.roche.com. Select Roche in your country at the top of the page and then select your country to find the appropriate local office contact information, or:
Visit our website at www.coaguchek.com. Locate the CoaguChek Worldwide box on the page and select your country. The CoaguChek Pro II system is manufactured for and distributed by:
In Australia:
Roche Diagnostics Australia Pty Limited ABN 29 003 001 205 31 Victoria Avenue Castle Hill, NSW, 2154 163 0 1 s n o i t a c i f i c e p S t c u d o r P l a r e n e G 164 11 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply. A Appendix A.1 Operator and patient ID barcode masks Barcode mask character A-Z, 0-9 Dollar ($) Asterisk (*) Tilde (~) Plus (+) Caret (^) Definition If not preceded by the Caret (^), the scan data character must be the same as the mask character. This character is not saved as part of the ID. If the characters are not the same, the scan data is not a valid ID. The scan data character in this position is kept as part of the ID. The scan data character in this position is not kept as part of the ID. The scan data character in this position must be a number, 0-9, and it is not kept as part of the ID. If the scan data character is not a number, the scan data is not a valid ID. The scan data character in this position must be an alpha character, A Z, and it is not kept as part of the ID. If the scan data character is not an alpha character, the scan data is not a valid ID. This mask character denotes that the scan data character must be equal to the next character in the barcode mask after the ^, and that the scan data character is kept as part of the ID. If the scan data character is not equal to the mask character following the ^, the barcode reading is invalid as an ID. The allowed maximum length of a barcode mask is 60 characters for 1D barcodes 300 characters for 2D barcodes 165 A x i d n e p p A 166 A.2 Example of barcode symbologies If a barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. When creating patient or operator barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. In particular, ensure that barcode size and print quality (as defined in ISO/IEC 15416 and 15415) are adequate. Inadequate print size and/or quality may lead to erroneous decoding. In addition every user must carry out a plausibility check on all data scanned into and displayed by the instrument. To reduce the probability of the barcode being misread, it is strongly recommended that you use the configuration options for patient and/or operator ID validation as appli-
cable to your specific workflow. These options are:
check ID against list or check ID for length1 use barcodes with check digits Always make sure that the entire barcode is covered by the green light beam when scanning. 1. If no operator/patient list can be used, it is recommended that you at least set a minimum length for the respective ID, even if your facility uses IDs of varying length. WARNING Avoidance of incorrect EAN 13 and Interleaved 2/5 barcode readings EAN 13 and Interleaved 2/5 barcodes, although widely used, are not recommended for patient/operator bar-
codes. If an EAN 13 or Interleaved 2/5 barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. If used nonetheless:
make sure that the very highest quality standards of barcode creation and reproduction are applied for EAN13: do not use the start sequences 978 (ISBN) and 979 (ISMN) as they will be ignored as a part of any ID code The barcode samples shown here are for illustration purposes only. If printed out, they can be used to check the barcode scanner. However, they are not meant to be used as a reference for size or resolution of real patient or operator ID barcodes. When creating patient or operator barcodes always refer to the relevant standard ISO/IEC 15416 and 15415 for size and resolution require-
ments and to the specification listed below. Print resolution Reflective contrast Symbol grade Module width
(minimum) Recommended Specification 300 dpi preferred 200 dpi minimum 70% or greater Grade C or above Grade B is preferred Symbol grades are A-F based on analysis of several quality elements. 0.16 mm (linear barcodes) 0.20 mm (2D barcodes) Remarks At 200 dpi issues with the wide-to-
narrow ratio may exist. Matte finish is preferred over gloss finish. Depending on quality grade parameters for a specific bar code, grade C may not be sufficient when motion, reflection, or poor lighting occur. 167 A x i d n e p p A 168 Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2/5 PDF417 QR Code DataMatrix A.3 Supported characters in 2D barcodes The 2D barcode scanner is able to read characters from the following unicode ranges:
Basic Latin (0021-007E) Latin-1 Supplement (00A1-00FF) Latin Extended-A (0100-017F) The 2D barcode scanner does not support Asian characters. 169 A x i d n e p p A 170 This page intentionally left blank. B Appendix B.1 Supplement for Observed Test Sequence Observed Test Sequence (OTS) The Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record an operators performance (e.g., for recertification purposes). The observer monitors an operator during a test to check that the test is being performed according to the recom-
mended procedures. He/she then evaluates the perform-
ance and passes or fails the operator. This assessment is saved together with the test result and any desired com-
ments. Observed Test Sequence options can only be config-
ured using a DMS. The availability of electronic config-
uration options will thus vary according to the data management software utilized by your institution. Con-
sult your system administrator. 171 B x i d n e p p A 172 Using the OTS function A request for an Observed Test Sequence comes from the DMS. The presence of the icon on the Patient Test button indicates a pending OTS request. Main Menu 09:15 am Pat. Test - OTS 09:15 am Observer 09:15 am Pat. Test - OTS 09:15 am Patient Test Control Test Review Results Setup Logout OTS enabled Observer Login Patient Test Alan Smithee Ann Casey Scan OTS enabled Observer Login Patient Test 05/29/2015 05/29/2015 05/29/2015 05/29/2015 Touch Patient Test. Observer:
1 In the Pat. Test -OTS menu, the Patient Test button is grayed out (disabled) until the observer has logged in. 2 3 4 Touch Observer Login. Wait until the observer list is displayed. Select your observer ID by touching the corre-
sponding button, or scan your operator ID (which is also your observer ID in this case). Only operators with OTS observer rights are listed in the Observer Login list. 5 6 7 Enter the (optional) password. After you enter your password, touch to log in. The Pat. Test - OTS menu is displayed again. The Patient Test button is now active. Hand the meter to the operator who can now per-
form the patient test under supervision. Pat. Test - OTS 09:15 am Remove 09:15 am Observer Login Observer 09:15 am OTS enabled Observer Login Patient Test I-010 Observer ALAN SMITHEE, please log in to proceed. Otherwise the OTS test will not be complete. OTS passed:
Pass Fail Measurement Result OK?
Reject Accept Comment:
05/29/2015 05/29/2015 05/29/2015 Touch Patient Test. Operator:
1 Perform the patient test as usual. Once the test is com-
pleted, the observer has to complete the next steps. Hand the meter back to the observer. 2 Observer:
3 4 to 5 6 to log in again. Touch After you enter your password, touch proceed with the assessment. Assess the operators performance by touching Pass or Fail. Assess the test result by touching Accept or Reject. Touch Touch 7 8 The OTS information is saved together with the test result. to add a comment. to return to the Pat. Test - OTS screen. 173 B x i d n e p p A 174 This page intentionally left blank. C Appendix C.1 Option: Wireless network (WLAN) Preliminary note This appendix has been developed to explain the wireless communication principles of the CoaguChek Pro II system1 and to help your facilitys information technol-
ogy/management team(s) in effectively deploying the CoaguChek Pro II system on your wireless network. Whether your meter has wireless capability or not depends on the system configuration that you purchased. Item Description CoaguChek Pro II meter CoaguChek Pro II meter Meter Meter, equipped with WLAN functionality REF/Catalog Number 07237944190 07210841190 For information on WLAN registration see addendum WLAN registration information, Addendum to the Operator's Manual for the CoaguChek Pro II meter at www.coaguchek.com 1. The CoaguChek Pro II system is certified by the Wi-Fi Alliance. 175 C x i d n e p p A 176 Background The CoaguChek Pro II meter can only be configured through a data management system to communicate wirelessly. The data management system (DMS) is also used to set-up and configure the meter to connect to one hospital specific Wireless Local Area Network (WLAN1). WLANs use electromagnetic waves in the 2.4 GHz frequency range to wirelessly transmit data2. The CoaguChek Pro II system adheres to IEEE Standard 802.11g (2.4 GHz range)3. The system is backwards compatible to 802.11b. During wireless communication to an Access Point (AP), the CoaguChek Pro II meter recog-
nizes the existent AP WLAN protocol configuration
(802.11b or 802.11g) and automatically transmits data using the appropriate communication protocol4. The loss of signal or access to bandwidth of one particu-
lar client may vary depending on one or more of the fol-
lowing situations: the type and number of other clients, the performance of the Access Point, the presence of electromagnetic disturbances, and other potential inter-
fering factors, e.g., concrete walls. The CoaguChek Pro II meter uses a burst-like communi-
cation protocol that will only consume bandwidth if there is actually data to be transferred. Compared to other applications, such as Voice over Internet Protocol (VoIP) or multi-media applications, the meters bandwidth con-
sumption is minimal. If the WLAN that the CoaguChek Pro II meter seeks to connect to is degraded, the meter design minimizes the impact on functionality. 1. 2. 3. 4. WLAN is also commonly referred to as wireless LAN or Wi-Fi. For the wireless functionality to work properly, the wire-
less module must first be configured by your system administrator. While the CoaguChek Pro II system adheres to the 802.11g standard, it uses only channels 1-11. Channels 12-14 are not used by the system. WLANs are organized in cells. A typical WLAN cell consists of Access Point(s) that are connected to the
(wired) Local Area Network and one or more clients, e.g., CoaguChek Pro II meters along with other clients such as portable computers. Technical implementation Prior to connecting any wireless device to a wireless net-
work, it is recommended that a WLAN site survey be per-
formed. The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and per-
formance to support any new radio frequency (RF) appli-
cation or device. The survey will also detail RF signals, including all existing WLANs along with any competing RF signals and interferences (building structure related and other wireless equipment / devices). As part of an RF implementation of the CoaguChek Pro II system, it is recommended that at minimum one Hand-
held Base Unit be hard wired per floor. A networked Handheld Base Unit provides redundancy if a wireless network malfunctions or loses service. If the CoaguChek Pro II meter with RF is used in an area with low signal or interferences, it is recommended to install a connected Handheld Base Unit for redundancy. The redundancy of the connected Handheld Base Unit allows immediate transmission of patient results when the meter is docked. 177 C x i d n e p p A 178 The current RF system consists of an antenna and a WLAN system-on-chip (SoC) along with other compo-
nents. The WLAN system-on-chip is the core of the WLAN system. The RF system used in the CoaguChek Pro II meter specifically adheres to the following specifi-
cations:
Its WLAN system-on-chip supports IEEE 802.11b and 802.11g. It works seamlessly together with other Wi-Fi certified transceivers. It also implements the Wi-Fi Protected Access (WPA - Enterprise and WPA - Personal), Wi-Fi Protected Access 2
(WPA2 - Enterprise and WPA2 - Personal), and Wired Equivalent Privacy (WEP) security mecha-
nisms with Temporal Key Integrity Protocol (TKIP) and Advanced Encryption Standard (AES). The CoaguChek Pro II meter interoperability Wi-Fi certificate can be accessed at http://certifications.wi-fi.org/search_products.php. Further information including a glossary of terms, frequently asked questions, and other topics related to Wi-Fi technology can be found on the Wi-Fi Alliance site (http://www.wi-fi.org/). The used channels in the 2.4 GHz-band are chan-
nels 1-11, which are the legally allowed channels in the USA. (Channels 12-14 are not used by the CoaguChek Pro II meter.) RF output power is approximately 15 dBm at a data rate of 54 MBPS. RF specific functionalities and effective performance claims The CoaguChek Pro II system offers the option of wireless network connectivity (WLAN/Wi-Fi). This module can only be configured by a data manage-
ment system (DMS), which activates the meters wireless communication and data transfer capabilities. Wireless connectivity can help to ensure that updates to informa-
tion in the DMS are sent immediately to all networked meters. Meters with an integrated and activated wireless option use the Handheld Base Unit for recharging and/or as a redundant communication option to exchange data with the DMS. The meter also has to be docked if the hospital changes security protocols. When this change occurs, it may lock out all meters until docked and reconfigured with the new protocol. As described above, the CoaguChek Pro II meter sup-
ports the 802.11g standard. This translates into the fol-
lowing RF specific performance claims:
179 C x i d n e p p A 180 The CoaguChek Pro II meter is capable of transfer-
ring to a suitable DMS, via WLAN, a data set of up to 1000 result records, 100 strip and control lot records, and 500 operator ID records in less than 15 minutes, when operated in a typical WLAN environ-
ment (correct WLAN administration, typical popu-
lation of other clients present, any of the supported security models enabled). Immediately after the test has been completed
(and returning to the main menu screen), the CoaguChek Pro II meter will attempt to connect to the DMS. In line with the industry communication standard POCT1-A, the DMS must acknowledge the meters request for connection and actively query for the result. Only upon receipt of this DMS query, the meter will send the result. Hence the effective time for transmitting results depends on infrastructure, DMS workload, etc. Once the DMS sends a query, however, the meter will respond within a few seconds. A CoaguChek Pro II meter with wireless connectiv-
ity enabled will communicate results after every test or, when the meter is idle; it will automatically attempt to communicate with the DMS every 10 minutes. A typical range for direct connection between the CoaguChek Pro II meter and the access point (air, direct view, low disturbances) is up to 15 to 20 meters (49 to 66 feet). The actual range depends on the positioning of the access points antennas and other topological properties of the space between WLAN device and AP. Additionally, dynamic control of the transmitting power of the access point may reduce the maximum distance between WLAN device and AP within which communication can be guaranteed. The CoaguChek Pro II system is designed such that it coexists with other wirelessly communicating devices. The CoaguChek Pro II system does NOT include any real-
time or even time critical wireless functionality. It commu-
nicates exclusively single, digital data fields. It does NOT communicate continuous waveform data. Note: A degraded WLAN connectivity will not impact the functionality of the meter but may delay the com-
munication of results to the DMS. Users should be aware that real-time communication of data cannot be guaranteed by the CoaguChek Pro II meter. During the exchange of large data packages a short-term delay in the meter response might occur. 181 C x i d n e p p A 182 This page intentionally left blank. 183 Index A Accessories ............................................................ 161 Adapter (power supply) ........................................33 Admin. ID ............................................................7275 Applying a blood sample .................................. 108 Auto Off ......................................................................62 B Barcode ................................................ 100, 105, 122 Masks ............................................................... 165 Symbologies ................................................... 168 Barcode scanner .....................................................29 Battery pack Installing or replacing ............................3640 Beeper ............................................ 60, 106, 121, 130 Blood sample (testing) ................................ 93115 C Capillary blood sample (testing) ............. 93115 Cleaning .........................................................150154 Meter housing ............................................... 152 Test strip guide ............................................. 153 Coagulation process ........................................... 108 Code chip ............................................................9798 Inserting ..............................................................98 Code number ............................................................98 Comments Adding .............................................................. 113 Computer ...................................................................67 Connection .........................................................6368 Consumables ......................................................... 161 Contrast ......................................................................49 Control solution Applying .......................................................... 124 Code chip ........................................................ 122 Preparing ......................................................... 118 Custom range ....................................................80, 81 D Data transfer .................................................139141 Date ..............................................................................54 Disinfection ...................................................150154 Display Format .................................................................56 Icons ............................................................. 3031 Disposal ...........................18, 34, 96, 114, 126, 132 E Error messages ..................................................... 155 F Fingertip ................................................................... 108 H Handheld Base Unit ..... 29, 36, 41, 67, 139141, 161, ............................................................................ 177 I Icons Drop .................................................................. 107 Dropper ...................................................123, 131 Hourglass ..................................... 107, 123, 131 Identification plate ............................................5 Overview ..................................................... 3031 Packaging ............................................................5 ID Setup .............................................................. 7078 Overview .............................................................70 Infrared interface ....................................................29 K Keypad ..................................................................... 100 L Lance ........................................................................ 108 Language ...................................................................52 Lockout Operator .............................................................86 Quality Control ....................................... 83, 102 Logout ...................................................................... 101 M Mains voltage ................................................. 27, 159 Measurement x e d n I Performing .............................................102115 Preparing ............................................................97 184 Measuring range .................................................. 159 Memory Button ............................................................... 135 Patient Result ................................................. 136 Quality Control .............................................. 137 Meter Overview .............................................................28 Reset ................................................................. 158 O Observed Test Sequence (OTS) ............171173 Operating conditions ................................... 27, 159 Operator Lockout ...............................................................86 Logout .............................................................. 101 Password ......................................................... 101 Operator ID ................................................................76 Operator list ..................................................101, 142 Options ................................................................ 5868 Overview Meter elements ................................................28 Setup ............................................................ 4548 P Parameter selection ............................69, 106, 135 Password ................................................................. 101 Patient ID ....................................................................77 Patient list ......................................................104, 143 Power adapter ..........................................................33 Power on ....................................................................99 Power supply Charging terminals (Handheld Base Unit) 29 Printer ..........................................................................68 Product specifications ........................................ 159 Proficiency sample Applying .......................................................... 132 Proficiency test Preparing ......................................................... 128 Putting the meter into operation ............... 3541 Q QC Range ...................................................................80 QC Settings ....................................................... 7985 QR code .............................................................. 6466 Quality Control Lockout .....................................................83, 102 Memory ............................................................137 Preparing .........................................................118 Result .......................................................125, 132 R Relative humidity ...........................................27, 159 Reset .........................................................................158 Result confirmation ......................................51, 112 Review Results ............................................ 133146 Data transfer ........................................ 139141 RF (radio frequency) ....................................23, 177 S Safety Protection against infection ....................... 17 User qualification ........................................... 17 Scan (button) ......................................100, 105, 122 Screen ................................................................. 4957 Setup Admin. ID ................................................... 7275 Auto Off ............................................................. 62 Beeper ................................................................ 60 Computer ........................................................... 67 Connection ................................................ 6368 Contrast ............................................................. 49 Date ..................................................................... 54 Display format ................................................. 56 ID Setup ...................................................... 7078 Language .......................................................... 52 Operator ID ....................................................... 76 Options ........................................................ 5868 Parameter selection ....................................... 69 Patient ID ........................................................... 77 Printer ................................................................. 68 QR code ...................................................... 6466 Result confirmation ....................................... 51 Screen .......................................................... 4957 Sort ...................................................................... 58 STAT test ........................................................... 88 Time ..................................................................... 55 Units .................................................................... 50 Software license ...................................................162 Sort .............................................................................. 58 STAT test Configure ...........................................................88 Perform ............................................................ 115 Storage ..................................................................... 147 Switching on the meter ........................................99 Symbols Error messages ............................................. 155 System Administrator .....................................7275 T Target value ..............................................................82 Temperature range ................................ 27, 93, 159 Test principle ............................................................13 Test result (patient test) .................................... 110 Test result (quality control) .....................125, 132 Test strip Icon ................................................ 106, 121, 130 Inserting ........................................ 106, 121, 130 Test strip guide cover ......................................... 153 Thromboplastin ........................................................13 Time .............................................................................55 Troubleshooting ................................................... 155 U Unit (test result) ................................................... 110 Units (of measure) ..................................................50 V Voltage ........................................................................27 W Warranty .................................................................. 164 Wi-Fi .............................................................................24 WLAN ..............................................................175181 185 x e d n I 186 This page intentionally left blank. ACCU-CHEK, COAGUCHEK and SAFE-T-PRO are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.coaguchek.com www.poc.roche.com N E 1 1
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cobas h 232 POC system Operators Manual Manual version Revision date Changes Version 1.0 Version 2.0 Version 3.0 Version 4.0 2006-10 2009-09 2011-09 2014-05 Version 5.0 2015-xx New document Minor revisions from internal review Update to SW 03; enhanced error messages Added description of new OTS functionality, miscellaneous minor revisions Transition to new meter hardware: 2D barcode scanner; wireless LAN option; new battery pack. Update to SW 04.00. Update of cleaning and disinfection section; added safety informa-
tion on battery packs; deleted appendix for addresses; misc. editorial revisions. cobas h 232 POC system Operators Manual Version 5.0 0 7469101001 (01) 2015-XX EN 2006-2015, Roche Diagnostics GmbH. All rights reserved The contents of this document, including all graphics, are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein. 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. Please send questions or comments about this manual to your local Roche representative. ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche. The Wi-Fi CERTIFIED Logo is a certification mark of the Wi-Fi Alliance. On the packaging and on the identification plate of the meter 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 instrument. Temperature limitation (Store at) Manufacturer Catalogue number IVD In vitro diagnostic medical device This product fulfills the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices 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). On meters with WLAN capability:
This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada For other WLAN certifications, see label on bottom of battery compartment and addendum for information on WLAN registration. The user is fully responsible for the installation, use and upkeep of the cobas h 232 meter. 5 This page intentionally left blank. Table of Contents 1 2 3 Introduction Putting the Meter into Operation 11 The cobas h 232 meter................................................................................................................. 11 Test principle ..................................................................................................................................... 13 Contents of the Pack ...................................................................................................................... 13 1.1 Important safety instructions and additional information......................................................... 14 Safety information............................................................................................................................ 15 Disposal of the system ................................................................................................................... 17 Battery pack ....................................................................................................................................... 17 General care....................................................................................................................................... 19 Electrical safety ................................................................................................................................ 19 Electromagnetic interference ...................................................................................................... 20 Touchscreen....................................................................................................................................... 20 Local Area Network: protection from unauthorized access ............................................ 20 Wired network connection ........................................................................................................... 21 Wireless connectivity ...................................................................................................................... 22 Radiofrequency radiation exposure information.................................................................. 22 1.2 Overview of the meter and its accessories..................................................................................... 24 Meter ................................................................................................................................................... 24 Power supply...................................................................................................................................... 27 Test strip.............................................................................................................................................. 29 Handheld Base Unit ........................................................................................................................ 30 1.3 Overview of the Buttons and Icons used on Screen................................................................... 31 35 2.1 Installing or replacing the battery pack........................................................................................... 36 Removing the battery pack .......................................................................................................... 37 Installing the battery pack ............................................................................................................ 38 Powering the meter on and off................................................................................................... 41 43 Settings summary............................................................................................................................. 44 3.1 Basics setup ............................................................................................................................................... 49 Contrast ............................................................................................................................................... 49 Language ............................................................................................................................................ 51 Setting the date................................................................................................................................. 53 Setting the time................................................................................................................................. 55 Setting the display options for date and time ....................................................................... 57 Sound.................................................................................................................................................... 59 Auto off ................................................................................................................................................ 62 3.2 Data Handling setup ............................................................................................................................... 64 Connection ........................................................................................................................................ 64 QR Code .............................................................................................................................................. 65 Computer............................................................................................................................................. 68 Printer ................................................................................................................................................... 69 Result memory .................................................................................................................................. 71 Result units......................................................................................................................................... 75 Result display mode........................................................................................................................ 78 Diagnostics......................................................................................................................................... 80 3.3 ID Setup setting ........................................................................................................................................ 82 Administrator ID ............................................................................................................................... 83 Operator ID......................................................................................................................................... 89 Patient ID............................................................................................................................................. 92 Meter Setup 7 Table of Contents Performing a Test 3.4 Lockout setup............................................................................................................................................ 94 Operator lockout............................................................................................................................... 95 Quality control (QC) settings ....................................................................................................... 98 Quality control (QC) lockout ..................................................................................................... 100 Instrument quality control (IQC) lockout.............................................................................. 101 QC result format ............................................................................................................................ 102 Custom Range Troponin T......................................................................................................... 103 Reset test parameters.................................................................................................................. 105 Cleaning lockout............................................................................................................................ 106 STAT test configuration .............................................................................................................. 107 3.5 Optional Screens setup ....................................................................................................................... 109 113 Sample material ............................................................................................................................. 115 4.1 Preparing to test .................................................................................................................................... 115 Code chip ......................................................................................................................................... 116 Inserting the code chip .............................................................................................................. 117 Test steps (overview) ................................................................................................................... 118 Powering on the meter................................................................................................................ 119 Logging in ........................................................................................................................................ 120 4.2 Performing a test................................................................................................................................... 123 Inserting a test strip .................................................................................................................... 127 Displaying, confirming or adding comments to results.................................................. 132 Displaying the test result as QR code ................................................................................... 135 STAT tests ........................................................................................................................................ 136 137 5.1 Preparing to run a quality control test .......................................................................................... 137 5.2 Performing a quality control test..................................................................................................... 139 Quality control (QC) ..................................................................................................................... 139 Displaying the QC result as QR code .................................................................................... 146 Instrument quality control (IQC).............................................................................................. 147 151 Reviewing test results.................................................................................................................. 151 Patient history................................................................................................................................. 153 All results.......................................................................................................................................... 154 Quality control (QC) results....................................................................................................... 155 Instrument quality control (IQC) results ............................................................................... 156 Maintenance history .................................................................................................................... 157 159 Data handling ................................................................................................................................. 159 Computer (Setup option)............................................................................................................ 160 Operator lists................................................................................................................................... 161 Patient lists....................................................................................................................................... 162 Barcode scanner............................................................................................................................ 163 Stored test results and comments .......................................................................................... 163 Control Testing and Quality Control Extended Functionalities Review Results 4 5 6 7 8 Table of Contents 8 9 10 11 A B C D Troubleshooting Maintenance and Care General Product Specifications 165 8.1 Conditions for storage and shipping ............................................................................................. 165 Storage.............................................................................................................................................. 165 Shipping............................................................................................................................................ 166 8.2 Cleaning and disinfecting the meter ............................................................................................. 167 Difference between cleaning and disinfecting.................................................................. 167 When should the meter be cleaned and disinfected? .................................................... 167 What to clean and disinfect?.................................................................................................... 167 Recommended cleaning/disinfecting agents..................................................................... 169 Cleaning/disinfecting the exterior (meter housing)......................................................... 169 Cleaning after contamination due to mispipetting........................................................... 170 Cleaning the test strip guide cover ........................................................................................ 171 Cleaning the visible area of the test strip guide................................................................ 172 173 Errors and unusual behavior without error messages .................................................... 174 Meter reset ...................................................................................................................................... 176 177 10.1 Operating conditions and technical data..................................................................................... 177 Technical data................................................................................................................................ 177 Sample material............................................................................................................................. 178 Storage and transport conditions ........................................................................................... 178 10.2 Further information............................................................................................................................... 178 Ordering information ................................................................................................................... 178 Product limitations........................................................................................................................ 180 Information about software licenses .................................................................................... 180 Repairs .............................................................................................................................................. 180 180 181 A.1 Working with barcodes....................................................................................................................... 181 A.2 Operator and patient ID barcode masks...................................................................................... 182 A.3 Example of barcode symbologies ................................................................................................... 183 A.4 Supported characters in 2D barcodes .......................................................................................... 185 187 B.1 Option: Wireless network (WLAN) ................................................................................................. 187 Preliminary note............................................................................................................................. 187 Background..................................................................................................................................... 187 Technical implementation.......................................................................................................... 188 RF specific functionalities and effective performance claims...................................... 190 193 Observed Test Sequence (OTS) ............................................................................................. 193 Using the OTS function............................................................................................................... 194 197 199 Supplement for Observed Test Sequence Contact Roche Index Warranty Appendix Appendix 9 Table of Contents This page intentionally left blank. 10 Introduction 1 Introduction The cobas h 232 meter The cobas h 232 meter is an instrument for the quantitative evaluation of immunoassays using the gold-labeling technique. The rapid diagnostic tests in strip format available for this meter support efficient diagnosis and assessment of cardiovascular diseases. The evaluation of these tests with the cobas h 232 meter combines the advantages of a rapid diagnosis with enhanced clinical interpretation of quantitative values (in comparison with qualitative tests). In addition, automated evaluation provides more reliable results by eliminating the potential sources of error associ-
ated with visual reading. Refer to the package inserts accompanying the test strips for detailed information on specific tests. Readings may be carried out directly where the blood samples are taken. Therefore, the cobas h 232 meter is ideal for use at the point of care in emergency rooms, intensive care units and ambulances, as well as by cardiologists and general practitioners. The cobas h 232 meter is rapid and easy to operate: Insert an unused strip in the meter and apply the sample. After the reaction period, the meter provides a quantitative result; in addition, a qualitative result is pro-
vided prior to the end of some tests. The cobas h 232 meter has the ability to connect to a data management system (DMS) by means of wireless communication (if the meter is equipped with WLAN functionality) or through the Handheld Base Unit from Roche Diagnostics (available separately). The cobas h 232 meter supports data exchange via the POCT1A standard or directly via WLAN. Data management sys-
tems 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. 11 Introduction 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 cobas h 232 meter according to your needs before initial use. Refer to Chapter 3, Meter Setup. Be sure to read the Important safety instructions and additional information section in this chapter before operating the system. For all questions about the cobas h 232 system that are not answered in this manual, contact your Roche representative (see Contact Roche on page 197). In order to expedite troubleshoot-
ing, please have ready your cobas h 232 meter, its serial number, this manual, and all related consumables when you call. If you connect your cobas h 232 meter to a cobas IT 1000 data management system or another PC/DMS, you will not be able to print directly from the meter to a printer. In order to print out meter data, use printers connected to the respective PC/DMS. 12 Introduction Test principle Two lines (signal and control line) in the detection zone of the test strip indicate whether the analyte to be determined is present in the sample material. These lines are detected by the cobas h 232 meter with the help of an LED (lighting the detection zone) and a camera sensor (imaging the detection zone). The test signal (signal line) increases in intensity in proportion to the concentration of the respective analyte. Integrated system software converts the signal intensity to a quantitative result, which is then displayed on the screen at the end of the measurement. The accuracy of the measurement is ensured through a simple principle: Every test strip box includes a code chip that contains all test and lot-specific information in electronic format. The test strips are labelled with a barcode on their underside and are hereby assigned to a specific code chip. When you insert a test strip from a new strip lot for the first time, the meter prompts you to plug in the corresponding code chip. The information is now read from the code chip and stored for future tests. Contents of the Pack cobas h 232 meter Power adapter Universal Battery Pack Operators manual in English CD-ROM with operators manual in other languages Optionally available (not included in the scope of delivery):
Handheld Base Unit (docking station) for data transfer within a network or via USB
(Universal Serial Bus) For a personal printout of the operators manual in your language, contact your local Roche organization (see Chapter A). 13 Introduction 1.1 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 cobas h 232 Operators Manual. Please read these passages carefully. The safety alert symbol alone (without a signal word) promotes aware-
ness to hazards which are generic or directs the reader to related safety information. Indicates a hazardous situation which, if not avoided, could result in death or serious injury. Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. Indicates a hazardous situation which, if not avoided, may result in damage to the system. WARNING CAUTION NOTICE 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. Illustrations in this manual show two different kinds of hands:
Hand without glove Hand with glove 14 Safety information WARNING Introduction Operator qualification Only trained healthcare professionals may operate the cobas h 232 meter. Operators must also have received comprehensive instruction in the operation, quality control, and care of the cobas h 232 meter. Protection against infection and blood-borne pathogens Healthcare professionals using the cobas h 232 meter 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 cobas h 232 meter. 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. Dispose of used syringes, tubes, pipettes, test strips, and all other materials coming into contact with blood according to your institu-
tions infection control policy. Follow all health and safety regulations in force locally. 15 Introduction Allergy or injury caused by reagents and other working solutions CAUTION Direct contact with reagents, detergents, cleaning/disinfection solutions, or other working solutions may cause skin irritation or inflammation. WARNING Always use protective gloves. Observe the cautions given in the package inserts of the reagents and cleaning/disinfection solutions. If a reagent, control, or cleaning/disinfection solution comes into con-
tact with your skin, wash it off immediately with water. Follow all health and safety regulations in force locally. Avoidance of electrical shock, fire, and explosions 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 cobas h 232 meter, the power supply unit, or the battery pack and protect these against shaking and vibrations. 16 Introduction Disposal of the system WARNING Infection by a potentially biohazardous instrument The cobas h 232 meter or its components must be treated as potentially biohazardous waste. Decontamination (i.e., a combination of processes including cleaning, disinfection and/or sterilization) is required before reuse, recycling, or disposal. Dispose of the system or its components according to the appropriate local regulations. Always remove the battery pack before thermal disinfection. Battery pack The meter contains a rechargeable battery pack that 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 adapter). NOTICE Use only the specially designed battery pack provided by Roche Diagnos-
tics. Using any other type of battery may damage the system. 17 Introduction WARNING Possible hazards posed by the battery pack Damaged or swollen battery packs can overheat, catch fire, or leak. Immediately cease use of cobas h 232 meters with damaged or swollen battery packs and under no circumstances recharge them (do not place in the Handheld Base Unit). Overheating can cause the battery pack to catch fire or explode. Never throw the battery pack or the meters onto a fire. Do not dis-
mantle, 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 cobas h 232 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 position-
ing 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. 18 Observe the following general safety instructions for handling the battery pack:
Introduction Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facilitys guidelines on the disposal of electronic waste equipment. When storing or disposing of the battery pack, use the manufacturer's original packaging. Save or download data from the meter prior to replacing the battery pack to prevent loss of data (see Chapter 7). Always power the meter off before removing the battery pack. When the Battery Low warning is displayed, the meter must be returned as soon as pos-
sible to the Handheld Base Unit or connected to the power adapter for recharging. When the battery capacity is too low for further tests, the meter must be returned imme-
diately to the Handheld Base Unit or connected to the power adapter for recharging. General care NOTICE Electrical safety NOTICE Clean the meter only with the solutions recommended (see page 165). Using other solutions may result in incorrect operation and possible fail-
ure of the system. Make sure that the meter is thoroughly dried after cleaning and disinfecting. Never run the meter if the electrical power adapter or the attached cable is visibly damaged. If there is any visible damage contact your local Roche service for inspections. 19 Introduction Electromagnetic interference The meter fulfills the IEC 61326-2-6 requirements for emitted interference and interference immunity. Do not use the meter near strong electromagnetic fields, which could interfere with the proper operation of the meter. Electrostatic discharges may cause malfunction of the meter. Touchscreen NOTICE Use only your finger (even when wearing gloves) or special pens designed for use with handheld devices to touch the screen elements. Using pointed or sharp-edged objects can damage the touchscreen. Do not use the system in direct sunlight. Direct sunlight may reduce the life expectancy and functionality of the screen. 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 Inter-
net. Customers are responsible for the security of their local area network, especially in protect-
ing 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. 20 Introduction Wired network connection If connected to a local area network, the cobas h 232 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 users account name or parts of the users full name that exceed two consecutive characters. Passwords must be at least eight characters in length. Passwords must contain characters from at least three of the following four categories:
English uppercase alphabetic characters (A through Z) English lowercase alphabetic characters (a through z) Numeric characters (0 through 9) Non-alphabetic characters (for example, !, $, #, %) Examples of weak passwords uhxwze11 contains no upper case letter. UHXW13SF contains no lower case letter. uxxxxx7F contains the same character more than four times. x12useridF contains a substring of the user ID longer than four characters. To ensure that your cobas h 232 meter functions properly, observe the operating and storage conditions as given in the chapter General Product Specifications, starting on page 177. 21 Introduction Wireless connectivity If the meter is equipped with WLAN functionality:
Wireless connectivity allows the meter to send data (test results, patient IDs, operator IDs, etc.) to the data management system without the need to return the meter to the Handheld Base Unit. This feature must be configured by the system administrator. Observe the guidelines of your facility for using wireless local area network connections. For a description of the cobas h 232 meters ability to connect to Wireless Local Area Networks (WLAN, Wi-Fi), see appendix B. Radiofrequency radiation exposure information Glossary:
FCC stands for Federal Communications Commission (USA). RF stands for radio frequency RSS stands for Radio Standards Specification (Canada). WLAN stands for Wireless Local Area Network The Industrial, Scientific and Medical (ISM) radio frequencies may contain emissions from micro-
wave ovens, heaters, and other noncommunication devices. While these types of devices usually pose no threat of interference as they are low-powered devices, the possibility exists that some industrial high power systems may wipe out any attempted communication use of a WLAN. Therefore, perform a site survey and interference analysis with a spectrum analyzer to view the entire spectrum, looking for signals that might not only be within the frequency range of the intended WLAN but also could be near or at the same frequency and cause interference. Roche Diagnostics supports industry wireless standards and recommends using products that have Wi-Fi certification. This certification tests products to the 802.11 industry standards for basic connectivity, security, authentication, Quality of Service (QoS), interoperability and reliability. The Wi-Fi CERTIFIED logo is an assurance that the Wi-Fi Alliance has tested a product in numerous configurations and with a diverse sampling of other devices to ensure compatibility with other Wi-Fi CERTIFIED equipment that operates in the same frequency band. The Wi-Fi Alliance network of independent test labs conducts inter-
operability testing programs to ensure that wireless devices work together and support secure connections. 22 Introduction The cobas h 232 system complies with FCC radiation exposure limits set forth for an uncon-
trolled environment. This equipment should be installed and operated with minimum distance of 20 cm (8 inches) between the radiator and your body. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter. Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment. This device complies with Part 15 of the FCC Rules and with RSS-210 of Industry Canada. Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation. The cobas h 232 system complies with the emission and immunity requirements described in EN 61326-2-6. It has been designed and tested to CISPR 11 Class B. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful inter-
ference to radio or television reception, which can be determined by powering the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This Class B digital apparatus complies with Canadian ICES-003. 23 Introduction 1.2 Overview of the meter and its accessories Meter B A C D E F I G 24 Introduction H N A Touchscreen Shows results, information, icons and results saved in the memory. To select an option, simply touch the button lightly. B On/Off button Press this button to power the meter on or off. E Barcode scanner (LED) Operator and patient IDs can be read into the meter using the integrated barcode scanner (only meter versions with a serial number greater than 200 000). F Battery compartment cover Remove to insert the battery pack. C Opening for sample application G Meter identification plate Opening in the test strip guide cover that enables you to apply blood once the test strip is inserted. D Test strip guide cover Remove this cover to clean the area underneath (if it has become soiled, e.g., with blood). See page 5 for symbol explanation. H Wireless LAN label If the meter supports wireless connectiv-
ity: This label displays registration num-
bers that are specific to the meter RF hardware. 25 Introduction I K L M J I J Test strip guide Insert the test strip here. Infrared (IR) window Supports data communication with the
(optional) Handheld Base Unit. Covered by the semi-transparent rear panel. K Connection socket for power adapter Plug in the power adapter here. L Code chip slot Insert the code chip here. M Charging terminals Used for power supply and/or charging the battery pack when the meter is docked in the (optional) Handheld Base Unit. 26 Introduction Power supply N O N Battery Pack Powers the device. O Power adapter Powers the device and charges the battery pack. The meter can be operated with the rechargeable battery pack only or together with the power adapter or the (optional) Handheld Base Unit, which both charge the battery pack when inserted. Insert the battery pack even when always using the power adapter or the Handheld Base Unit. This ensures that you will not lose the date and time settings if the power goes out. Results are retained in the memory together with the corresponding date and time, as well as all other set-
tings, even when no battery pack is inserted. To save power, the meter can automatically power itself off after a programmable period of time, if no buttons are pressed or new test strips are inserted. When the meter powers itself off, all test results obtained up to that point remain in memory and the settings are retained (see Auto off in the chapter entitled Data Handling setup on page 62). 27 Introduction Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 04/19/2015 During battery operation, the meter always displays the power level of the battery pack. The battery icon is divided into four segments which correspond to the battery power level. When replacing the battery pack, insert the new battery pack within 24 hours of removing the old one. Otherwise you may need to re-
enter date and time. Dispose of used battery packs in an environmentally responsible manner in accordance with applicable local regulations and directives. See Infection by a potentially biohazardous instrument on page 17. 28 Test strip Introduction R P Q S P Test area This area is evaluated by the meter via the camera. Q Sample application area The sample is applied to this area after inserting the test strip in the meter. R Barcode Assigns the strip to the corresponding code chip. The barcode is automatically read by the meter when the strip is inserted into the test strip guide. S Code chip Contains strip lot specific data. 29 Introduction Handheld Base Unit U T V Y X W Z T Charging contacts Used for power supply and/or charging the battery pack. U Status indicator Lights up when power is connected, charge indicator. V Infrared (IR) window For communication with the meter. W Extension piece For cobas h 232 meter. X Data ports (Ethernet/RJ45 and USB) For connecting the device to a Data Management System (DMS). Y Connection socket for the power adapter Here you can plug in the power adapter of the Handheld Base Unit. Z Removable cover for configuration switch The switch sets the mode of operation for the Handheld Base Unit. The Handheld Base Unit can be ordered separately. For detailed information on usage and configuration please consult the operator's manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself. 30 1.3 Overview of the Buttons and Icons used on Screen The buttons and icons that appear during normal operation are shown here, along with a general explanation. Error messages and the description of the icons linked to them are provided in a separate chapter. See Troubleshooting starting on page 173. Introduction Button/Icon Meaning OK, save setting Cancel, discard setting Return (to previous menu) Decrease/increase a numeric value or Scroll through lists that are too long to be displayed at once Inactive button; value cannot be further decreased/increased or End of list in this direction is reached Return to the Main Menu screen List of tests of an individual patient Scroll through stored results Print displayed result (via infrared interface to corresponding printer) Display test result as QR code Add a comment Operator logout Operator login Operator must wait until the meter has completed an action. Insert test strip Remove test strip Test strip warming up Apply sample (the time left to apply sample is counted down in the screen alongside the required sample amount) 31 Introduction Button/Icon Meaning Apply QC sample (the time left to apply sample is counted down in the screen alongside the required sample amount) QC Insert code chip Open test strip guide cover for cleaning Battery status:
If the battery pack still has its full charge, all segments are lit Individual segments disappear one by one as the battery pack becomes weaker When there is no segment remaining, you can no longer perform a test. You can, however, still access the meters memory Operation with power adapter am pm Time between midnight and noon (in 12-hour time format) Time between noon and midnight (in 12-hour time format) Marks an information message Marks an error message or a warning
(see Chapter 9 Troubleshooting) Room or meter temperature is outside the acceptable range. The test strip guide cover is open. QC!
In a QC lockout condition, this icon indicates that one or more parameters are locked, while others still can be measured. 32 Introduction The following icons may appear when using the meter in conjunction with a data management system (DMS). Infrared interface is enabled (for communication with the computer and/or printer) Communication is taking place via WLAN An OTS request is pending Cleaning/Disinfection necessary 33 Introduction This page intentionally left blank. 34 2 Putting the Meter into Operation Putting the Meter into Operation Before using the meter for the first time, perform the following steps:
1 2 3 4 Install the battery pack (see page 38) Connect the power adapter to charge the battery pack Set the current date and time as well as the appropriate display format (see Chapter Meter Setup starting on page 43) Enter the settings of choice (language, quality controls where necessary, user administration, etc.) If the meter has no date/time settings (either because you are powering on the meter for the first time or because the battery pack was removed from the meter for more than 24 hours), you cannot perform a test. In that case powering on the meter takes you immediately to the Setup mode, where you must set the date and time. 35 Putting the Meter into Operation 2.1 Installing or replacing the battery pack When shipped, the battery pack is not installed in the meter. Unused battery packs lose their charge over time and have to be recharged before they can be used. After installing a new battery pack, the meter should be charged overnight before testing. Please note that the battery pack will only reach full capacity once it has been fully emptied and charged several times. Whenever the meter is placed on an active Handheld Base Unit or powered by the power adapter, the can be charged if necessary. icon is displayed. This icon shows that power is available and the meter Make sure that the permitted temperature range for charging the battery pack (12-32 C or 54-90 F) is maintained during installation and initial setup. 36 Removing the battery pack Putting the Meter into Operation 1 If a battery pack is already installed, make sure that the meter is powered off. 2 Place the meter face down on a level sur-
face. 3 Using a an appropriate starshaped screw-
driver, e.g. Torx size T5, remove the four screws holding the battery compartment cover in place. 4 Remove the battery compartment cover from the meter. The battery pack now vis-
ible is connected to the meter by a plug. 5 Carefully lift the battery pack and remove the plug connector. Disposal of used battery packs Do not dispose of the battery pack with normal domestic waste. Dispose of used battery packs in accordance with applicable local regulations and directives and your facilitys guidelines on the disposal of electronic waste equipment. 37 Putting the Meter into Operation Installing the battery pack 1 Loosen the screws on the battery com-
partment cover until they are protruding about 4-5 mm (2/10 in). 2 Hold the battery pack in your hand, with the wires and the plug pinched between your thumb and index finger. 3 Plug the connector plug into the socket and make sure it is fully inserted. 4 Place the battery pack inside the battery compartment as shown. To position the battery pack correctly, always align the ridges on the side of the battery pack with the ridges on the inside of the battery compartment. 38 Putting the Meter into Operation 5 Place the cover on the battery compart-
ment. Make sure that the plug connector wires do not get pinched between meter and cover. 6 Tighten all four screws until snug (do not overtighten). 39 Putting the Meter into Operation After inserting a new battery pack, the meter powers on automatically. Year:
Month:
Day:
Set Date 2015 1 1 Hour:
Set Time 3 04/19/2015 Minutes: 49 The Roche logo is displayed. If the meter does not power on automatically, the bat-
tery pack may be empty. Connect the power adapter for a minimum of 30 min-
utes, then remove the plug and try to power the meter on. If it powers on, the battery pack is charging properly. Within a short period of time, the start screen should appear. If the meter has been without power for too long, it will show the date and time settings dialog and you have to re-enter the date and time settings. The screens for entering the date and the AM PM time appear. 04/19/2015 7 Enter the date and time. After you have entered the correct information, confirm each screen with
. After installing a new battery pack, the meter should be charged overnight before testing. 40 Powering the meter on and off Putting the Meter into Operation 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the power adapter or by placing the meter on the Handheld Base Unit. 2 To power the meter off after use, press the button for approximately 1 second. 41 Putting the Meter into Operation This page intentionally left blank. 42 Meter Setup 3 Meter Setup Buttons are screen prompts that cause something to happen when touched. In this manual the names of all buttons are either shown as bold text or as the icon used on the button (e.g., for OK ). When text refers to other screen elements (e.g., Menu titles), these are written in italics. These screen elements are not active. You can open any displayed function by touching (or tapping) the button for it with your finger (or a special pen for this purpose). Tap means: Touch the button, then remove your finger from the touchscreen. The next screen appears once you remove your finger. Main Menu 09:15 am Patient Test Control Test Review Results Setup Basics Data Handling ID Setup Lockout Setup Optional Screens 1 Touch Setup to call up the Setup menu. 2 Select the group of settings of choice
(see the Settings summary following this section). For a description of the buttons and icons used on screen see page 31. 04/19/2015 04/19/2015 43 Meter Setup Settings summary The diagram below gives an overview of the setup areas that can be accessed on the meter. Setup Basics Contrast Language Date/Time Sound Auto Off Data Handling ID Setup Lockout Optional Screens 44 Connection Result Memory DD Result Unit Result Display Mode Administrator ID Operator ID Patient ID Operator Lockout QC Settings Cleaning Lockout STAT Test Con g. Start Info Result Login Result Con rmation Group Basics Setting Subgroup Contrast Language Date/Time Date Time Date formats Time formats Sound (Beeper) Volume Key Click Auto Off
[minutes]
* Default settings are labelled with an asterisk (*). Meter Setup Values *
0 10 (5*) Dansk Deutsch English *
Espaol Franais Italiano Nederlands Norsk Portugus Svenska An installable language 01/01/2011 *
12:00 am *
Day.Month.Year (31.12.2011) Month/Day/Year (12/31/2011) *
Year-Month-Day (2011-12-31) 24-hour time format (24H) 12-hour time format (12H), with am/pm *
Off Low Medium *
High Enable Disable *
Off 1 10 (default: 5 min *) 15, 20, 25, 30 40, 50, 60 45 Meter Setup Group Data Handling Subgroup Connection Setting Values *
QR Code Off *
Computer Printer Result Memory Result Display Filter All results *
Result Storage Mode Current Op. Res. No results deletion *
Delete oldest result Result Unit Select DD Res. Unit g/mL *
ng/mL mg/L g/L ng/L *
pg/mL ng/mL g/L Static *
Flashing Blank (off) *
None *
List Hidden List None *
Optional Required Scan Only None Optional *
Required Hidden List Result Display Mode ID Setup Administrator ID Operator ID Select TT Res. Unit
(with DMS and list available on meter)
(No list available on meter) Patient ID
* Default settings are labelled with an asterisk (*). 46 Group Lockout Subgroup Operator Lockout (only if Operator ID option is enabled) Setting QC Settings QC Lockout IQC Lockout QC Result Format Custom Range Trop T Reset Test Param. Cleaning Lockout STAT Test Config.
* Default settings are labelled with an asterisk (*). Meter Setup Values *
No *
Daily Weekly Monthly Every 3 months Every 6 months Yearly New Lot: Yes/No *
No *
Daily Weekly Monthly No *
Daily Weekly Monthly Pass/Fail *
Value Value & Pass/Fail Default Range*
Custom Range Do Reset No Reset *
No *
Daily Weekly Monthly Enable Disable *
47 Meter Setup Group Optional screens Subgroup Start Info Setting Result Login Result Confirmation
* Default settings are labelled with an asterisk (*). Values *
Enable Disable *
Enable Disable *
Enable Disable *
48 Meter Setup 3.1 Basics setup The Basics setup area contains the basic options for changing the user interface. Contrast Use the Contrast menu to adjust the display to your ambient light conditions and make it easier to read. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Contrast. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 49 Meter Setup Select Contrast Contrast:
(0-10) 5 04/19/2015 4 Touch or to change the contrast in a range from 0 to 10. Contrast 0 makes the screen very dark. Contrast 10 makes the screen very light. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 50 Language Use this setting to select the language for all displays (that contain text). Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Language. The current language setting is highlighted
(white type on a blue background). You can select either:
Dansk Deutsch English Espaol Franais Italiano Nederlands Norsk Portugus Svenska An optional language can be installed upon request (either directly at the plant or later by an authorised Roche Diagnostics service technician). 51 Meter Setup Select Language Franais Italiano Nederlands Norsk Portugus 04/19/2015 4 Touch or to display the language of choice on the screen. If the arrow is just an outline have reached the end of the list in the respec-
tive direction.
, you 5 Touch the button to select the language of choice. Your selection is now highlighted. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 52 Meter Setup 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Date/Time. Setting the date Use this menu to set the date of the meter. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 53 Meter Setup Setup - Date/Time Date Time Date/Time Format 04/19/2014 Set Date 2015 1 1 Year:
Month:
Day:
04/19/2015 4 From the Setup-Date/Time menu, touch Date to set the date. 5 Touch or to set the year, then the month, then the day. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. If the Set Date menu appeared automatically after powering the meter on, you must touch to complete the date setting. The Set Time menu will then be displayed next. 7 In the Setup-Date/Time menu, touch to return to the Setup-Basics menu or touch Time to move to the time setting. 54 Meter Setup 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Date/Time. Setting the time Use this menu to set the time of the meter. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 55 Meter Setup Setup - Date/Time Date Time Date/Time Format Set Time 3 Hour:
Minutes: 49 04/19/2014 AM PM 04/19/2015 4 From the Date/Time menu, touch Time to set the time. 5 Touch or to set the hours, then the minutes. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. If the Set Time menu appeared automatically after leaving the Set Date menu, you must touch to complete the time setting. The Main Menu will then be displayed next. 7 Touch to return to the Setup-Basics menu or touch Date/Time Format to move to the display options. 56 Setting the display options for date and time Select your preferred format for the date and time display. Meter Setup 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Date/Time. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 57 Meter Setup Setup - Date/Time Date Time Date/Time Format 04/19/2014 Select Date Format Date:
DD.MM.YYYY MM/DD/YYYY YYYY-MM-DD Time:
24H 12H 04/19/2015 4 From the Setup-Date/Time menu screen, touch Date/Time Format to set the dis-
play format. The current settings are highlighted (white type on a blue background). You can select one of the following display formats for the date:
Day.Month.Year, e.g., 31.12.2011 Month/Day/Year, e.g., 12/31/2011 Year-Month-Day, e.g., 2011-12-31 You can also select one of the following dis-
play formats for the time:
24H (24-hour time format), e.g., 14:52 12H (12-hour time format, supplemented by am/pm), e.g., 2:52 pm 5 Touch the button with the display format of choice for the date and time. Your selection is now highlighted. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 7 Touch menu. to return to the Setup-Basics 58 Sound The cobas h 232 meter can display information visually and alert you to special circumstances with a beep sound. When the Sound is activated, the meter beeps when:
Meter Setup it is powered on it detects a test strip pre-heating of the test strip is complete and you need to apply a sample the test is completed and the results are displayed (a long beep) an error occurs (three short beeps) the power adapter is connected when the meter is on a barcode is scanned successfully (short beep) the barcode scanner is disabled (two short beeps) a positive test result can be expected, while the measurement still is in progress (a long beep) We recommend that you keep the Sound (beeper) activated at all times. You can also activate a Key Click. When the Key Click is activated, the meter clicks briefly every time a button is touched, facilitating the input of information. 59 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 From the Setup-Basics menu, touch Sound. Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 60 Setup - Sound Volume Key Click 04/19/2015 Select Volume Off Low Medium High 04/19/2015 Key Click Enable Disable 04/19/2015 Meter Setup 4 From the Setup-Sound menu, touch Volume to set the volume level of the beeper. The current setting is highlighted (white type on a blue background). You may select from the following options:
Off Low Medium High 5 Touch Key Click in the Setup-Sound menu to turn the key click on or off. You may select from the following options:
Enable Disable 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 7 Touch menu. to return to the Setup-Basics 61 Meter Setup Auto off You can set up your meter so that it powers itself off automatically if it has not been used (no buttons touched or tests run) for a preselected time period. Use this feature to save power and extend the life of the batteries. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Basics. 3 In the Setup-Basics menu, touch Auto Off. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2015 Contrast Language Date/Time Sound Auto Off 04/19/2015 If the meter is connected to the power adapter or the Handheld Base Unit, the Auto Off func-
tion has a different effect:
If you do not work with operator IDs, the meter switches to the Main Menu, once Auto Off is triggered. If you work with operator IDs, the meter switches to Operator Login, once Auto Off is triggered. For information on Operator ID, see Operator ID on page 89. 62 Set Auto Off Time Minutes: 5 04/19/2015 Meter Setup You may select from the following options:
Off (meter never powers itself off) Time until meter powers itself off:
110, 15, 20, 25, 30, 40, 50, 60 minutes 4 Touch or to select the time of choice in minutes or to deactivate the feature. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 6 Touch to return to the Setup menu. 63 Meter Setup 3.2 Data Handling setup Connection In the Connection menu you can configure the data exchange with external devices. The meter can be connected either to a computer or a printer. In addition to this direct data output, test results may also be encoded as QR codes, which can be scanned to be used with other applica-
tions. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Data Handling. 3 From the Setup-Data Handling menu, touch Connection. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Data Handling 04/19/2015 Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2015 64 QR Code Meter Setup Connection 09:15 am 4 From the Connection menu, touch QR QR Code Off Computer Printer 04/19/2015 QR Code Show QR code:
09:15 am On Off Plain Text Coded Data URL Transmission 04/19/2015 Code. 5 Touch On to enable, or touch Off to disa-
ble QR code display. Your selection is now highlighted. If you have enabled this feature, select the style of the QR code to be displayed:
Plain Text Use this option to scan the result into a PC hosted application (e.g. electronic medi-
cal record). In order to do so, you need an external 2D barcode scanner attached to your PC. Once scanned, the test result and related meta-information (e.g. date, time, comments) will appear as plain text in your PC application. Coded Data Use this option to scan the result into a smartphone or tablet app, or a PC hosted application. URL Transmission Use this option to upload the result to a web based service (e.g. such as an elec-
tronic health record, etc.). For this option further parameters (URL, encryption key) must be set. 65 Meter Setup Ensure that your environment for reading QR codes (QR code reader, operating system, text processing application) is appropriate for your language. Disregard may lead to unpredictable behavior of your receiving component (PC, mobile device). For the options Coded Data and URL Transmission dedicated software programs or apps are required in order to use this feature. If you are a customer or a 3rd party IT provider, and you are interested to use this feature, contact your local Roche Diagnostics representative for additional information. 6 Touch Plain Text, Coded Data or URL Transmission, depending on the intended use. Your selection is now highlighted. If you have selected URL Transmission, the button will become active. Use this button to set the additional parameters. 7 8 to open the URL Transmis-
Touch sion menu. Touch URL to enter the URL to which the test result data will be uploaded
(note: the URL will be provided by your specialized service provider). Use Use Use mistake. to switch to input of numbers. to switch back to input of text. to backspace and correct a ABC 123 9 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. QR Code Show QR code:
09:15 am On Off Plain Text Coded Data URL Transmission URL Transmission 09:15 am 04/19/2015 URL Encryption Key 04/19/2015 URL 09:15 am A F K P U Z B G L Q V
. E J O T Y C H M R W
/
D I N S X 123 66 URL Transmission 09:15 am Encryption Key 09:15 am URL Encryption Key Key:
JD5G29F6U8V2WC4L Serial No.:
UQ85464711 Note: The encryption key and the serial number are required to decrypt QR code messages from this meter. Ensure they are available on the target system. 04/19/2015 04/19/2015 Meter Setup 10 Touch Encryption Key to display the Encryption Key menu. The Encryption Key menu displays two types of information which are required in order to identify and decode the transmitted test result. This information is required by the IT system, to which the test result is transmitted via the defined URL. Key This key is auto-generated by the meter and is required to decrypt the QR code information. Serial No. The meter's serial number is required to map the test result to the encryption key. Touch the New button, if you want the meter to generate a new encryption key. 11 Touch menu. twice to return to the QR Code 12 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. The Encryption Key information needs to be exchanged once with your specialized service pro-
vider prior to using the URL transmission method. Contact your specialized service provider in order to exchange this information. 67 Meter Setup Computer The cobas h 232 meter can connect with a computer or host system running appropriate soft-
ware (that is, a DMS must be installed). To use this connectivity feature, however, you need the optional Handheld Base Unit or the meter must be configured for wireless communication. If no wireless communication is configured, the connection is established in two steps. The meter connects to the Handheld Base Unit via infrared. The Handheld Base Unit is either connected to a single computer (via USB) or to a net-
work/host system (via Ethernet). The option Computer (when activated) can be used together with a DMS to set up:
operator lists, or patient lists (lists of patients to be tested) This eliminates the need for manual entry of these data. In addition, you can transfer test results stored in the meter to other systems for archiving or further evaluation. The option Computer controls the meters ability to communicate with a computer or a network. 13 From the Connection menu, touch Computer. Your selection is now high-
lighted. 14 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Connection 09:15 am QR Code Off Computer Printer 04/19/2015 Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. 68 Meter Setup Printer The meter can connect directly with three different infrared printers. The Handheld Base Unit cannot be used for this purpose. The option to print is displayed in a test result as well as directly after a test and when calling up stored results. Using the settings you enter here, you can activate or deactivate the meters ability to print. Connection to a printer can only be established via infrared. Enabling the connection to a printer disables the connection to a computer (and vice versa). Connection 09:15 am QR Code Off Computer Printer Select Printer Citizen CMP-10 GeBE GPT-437x Zebra MZ 320 04/19/2015 04/19/2015 15 From the Connection menu, touch Printer. Your selection is now high-
lighted. 16 Touch to confirm the selection. The next screen allows you to choose the type of printer you are using. 17 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 69 To print :
Align the meter with the IR printer At any test or memory screen, touch
. The printer icon only appears if the printer function is activated. Otherwise it is not displayed. Note: (Only applies if you are working with the meter in a language other than English.) With the exception of information you have entered
(such as patient ID and name, operator ID, comments), the printout will be in English. Meter Setup Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
01/25/2015 10:17 620 pg/ml 04/19/2015 70 Meter Setup Result memory Result memory settings allow to apply a Result Display Filter and to set the Result Storage Mode
(see page 73). All results recorded by the meter (patient results and quality controls) are stored automatically. Use the Sel. Res. Display Filter menu to select whether to display results (when calling up the Memory function) for all existing tests or only those from the current operator. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Data Handling . 3 From the Setup-Data Handling menu, touch Result Memory. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Data Handling 04/19/2015 Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2015 71 Meter Setup Setup - Result Memory Result Display Filter Result Storage Mode Sel. Res. Display Filter 4 From the Setup-Result Memory menu, touch Result Display Filter to select the results to display. All Results Current Op. Res. The current setting is highlighted (white type on a blue background). You may select from the following options:
04/19/2015 04/19/2015 All Results Current Op(erator) Res(ults) 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 6 Touch to return to the Setup-Data Handling menu. 72 Meter Setup The Sel. Res. Storage Mode menu tells the meter what to do when the memory is full. The meter memory can store a maximum of 2000 patient tests, 500 liquid controls, and 200 instrument quality controls. In case of a full memory, you can choose between:
No Result Deletion. This prevents data from being deleted inadvertently, but may (in case of a full memory) lead to the situation that you cannot perform a new measurement. Fur-
ther measurements will only be possible if stored data are transferred to the data man-
agement system (DMS) or you allow automatic deletion. Del. Oldest Result. Based on the 1st in/1st out principle, the oldest result will be auto-
matically deleted when necessary. This is the only option if the meter is used without a DMS (i.e. no data will be transferred and archived). The option No Result Deletion is available only when you are using a DMS. For more details see Extended Functionalities, starting on page 159. If you are not working with a DMS, this option is set to Del. Oldest Result. However, you only can select between these two options, if the meter is used together with a DMS and the Computer connection is enabled. In this case data stored in the meter are flagged, as soon as they have been transferred to the computer. Now the meter is allowed to delete those flagged data when necessary, even if you have selected the No Result Deletion option. 73 Meter Setup Setup - Result Memory Result Display Filter Result Storage Mode Sel. Res. Storage Mode No Result Deletion Del. Oldest Result 04/19/2015 04/19/2015 7 From the Setup-Result Memory menu, touch Result Storage Mode to select your storage mode. You may select from the following options:
No Result Deletion Del(ete) Oldest Result 8 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 9 Touch to return to the Setup-Data Handling menu. 74 Result units The result unit setting applies to the result display of D-Dimer and Troponin T tests only. Meter Setup 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Data Handling. 3 From the Setup-Data Handling menu, touch Result Units. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Data Handling 04/19/2015 Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2015 75 Meter Setup Setup - Result Units DD Result Unit TT Result Units 04/19/2015 Select DD Res. Unit g/mL ng/mL mg/L g/L 04/19/2015 4 From the Setup-Result Units menu, touch DD Result Unit. 5 From the Select DD Res. Unit menu, select the unit to be used for the D-Dimer result display. The current setting is highlighted (white type on a blue background). You may select from the following options:
g/mL ng/mL mg/L g/L 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 76 Setup - Result Units DD Result Unit TT Result Units 04/19/2015 Select TT Res. Unit g/mL ng/mL mg/L g/L 04/19/2015 Meter Setup 7 From the Setup-Result Units menu, touch TT Result Unit. 8 From the Select TT Res. Unit menu, select the unit to be used for the Troponin T result display. The current setting is highlighted (white type on a blue background). You may select from the following options:
ng/L pg/mL ng/mL g/L 9 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 10 Touch to return to the Setup-Data Handling menu. 77 Meter Setup Result display mode Test results may be displayed either with a static or a flashing display, the latter visually indicat-
ing that the measurement process has been finished. Once a result is available, the display starts flashing. Depending on the settings, this may be either a quantitative or qualitative result screen or an operator login screen. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Data Handling. 3 From the Setup-Data Handling menu, touch Result Display Mode. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Data Handling 04/19/2015 Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2015 78 Select Res. Display Mode Static Flashing 04/19/2015 Meter Setup 4 From the Select Res. Display Mode menu, select your display mode. The current setting is highlighted (white type on a blue background). You may select from the following options:
Static Flashing 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 6 Touch to return to the Setup-Data Handling menu. 79 Meter Setup Diagnostics Under Diagnostics, you will find information about the system, such as software version, number of data records stored, and configuration details. The Diagnostics menu contains functions rele-
vant for installation, maintenance and troubleshooting purposes. In case of technical problems the firmware version (Build) is an important information for the Roche Diagnostics customer support. The diagnostics screens shown here are for illustration purposes only. The Information shown on your meter may differ. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Data Handling. 3 From the Setup-Data Handling menu, touch Diagnostics. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2015 Data Handling ID Setup Lockout Optional Screens Setup - Data Handling 04/19/2015 Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2015 80 Setup - Diagnostics Software Wireless Setup 04/19/2015 Wireless Setup Wireless Setup - Network Use DHCP:
Use DNS:
SSID:
WLAN:
MAC:
04/19/2015 Meter Setup 4 From the Setup-Diagnostics menu, touch the button of the diagnostics screen you want to display. Software 5 Use and to toggle between the 04.00.00 06.03.00 06.03.00 06.03.00 04.00.00 03.00.00 03.00.00 Wireless Setup screens. 6 In either diagnostics screen, touch to return to the Diagnostics menu. Note: The Wireless Setup button is only available if the the WLAN function is enabled on this meter. Build:
Boot:
Kernel:
RootFS:
App:
MM-BL:
MM-FW:
04/19/2015 Enabled Disabled cobas h 232 01 23 45 67 89 AB Wireless Setup Wireless Setup - Connection DMS Name:
DMS Port Number:
DMS IP Address:
RF Security:
POCTServer 4711 0.0.0.0 WPA2-PSK (AES) 04/19/2015 Wireless Setup Test Wireless Setup - Test RF activated:
Associated:
Authenticated:
Con gured IP:
IP:
Subnet:
Gateway:
DNS:
Contacted DMS:
Connected to DMS:
Completed:
192.168.0.123 255.255.255.0 04/19/2015 81 Meter Setup 3.3 ID Setup setting Use the ID Setup menu to enter settings for user management and patient management. These settings are optional and set to Off/Inactive by default; the meter can be operated without these settings. There are three types of identification used with the meter:
System Administrator: The administrator has special rights to enter certain meter set-
tings and is the only one who can enter and change these settings. It is not necessary for administrator identification to be activated to use the cobas h 232 meter. However, it might be desired or necessary, depending on the regulatory environment and the site of use. Operator: The Operator ID is assigned to persons who use the meter to run tests. If you want to use Operator IDs, you have several options:
You may use Operator IDs to restrict the use of the meter to qualified personnel or a predefined group of users. In this case an operator list created on a DMS must be trans-
ferred to the meter, enabling you to select an Operator ID when logging in. For more details see Data handling, starting on page 159. You may use Operator IDs for informational purposes only, in order to assign stored measurement results to the users who performed the test. In this case Operator IDs may directly be entered on the meter (by keypad or scanner), with or without an operator list being available. Patient: The Patient ID is assigned to the person, whose test results are recorded. You can either:
block input of a unique Patient ID (in this case, every test is simply numbered in consecutive order) allow a unique Patient ID as optional, or require a unique Patient ID for every test. Patient lists created on a DMS can also be trans-
ferred to the meter, enabling you to select Patient IDs for a test from these lists. For more details see Data handling, starting on page 159. Operator IDs can be selected from a list (if available) or read by the barcode scanner on the front of the meter. If passwords were created, they must be entered via the onscreen keypad. Patient IDs can be entered by using the onscreen keypad or the barcode scanner on the front of the meter. 82 Administrator ID In the default setting, the meter is not protected with an Administrator ID, and all setup options are accessible to every user. If you set up an Administrator ID, the following setup areas are auto-
matically reserved only for the administrator (i.e., the person who knows the password):
Meter Setup Screen: Date/Time Data Handling ID Setup Quality control and the associated lockouts Optional screens The setup of an Administrator ID does not limit or alter the usage of the meter for measurements in any way. Furthermore setting up the Administrator ID has no impact on the usage of Operator IDs. Only the setup options as listed above are tied to administrator access. When you enter an Administrator ID, this ID must be entered from this point forward before any future IDs can be set up (anywhere in the ID Setup menu). The Administrator ID must also be entered before you can delete or change the Administrator ID. If you forget the Administrator ID, the meter setup may be unlocked via the external data man-
agement system (e.g., cobas IT 1000). If you dont use such a system and need to reset the Administrator ID, contact your Roche representative (see Chapter 10). 83 If an Administrator ID has not been set up yet:
1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 From the Setup-ID Setup menu, touch Administrator ID. Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - ID Setup 04/19/2015 Administrator ID Operator ID Patient ID 04/19/2015 84
****|
A Enter Administrator ID B G L Q V C H M R W E J O T Y D I N S X 123 F K P U Z Enter Administrator ID
****|
0 5 1 6 2 7 3 8 4 9 ABC Meter Setup 4 Using the onscreen keypad, enter the Administrator ID of choice (or the pass-
word provided by Roche Diagnostics). The ID can consist of up to 20 alpha-
numeric characters. Alphanumeric characters are any combi-
nation of A - Z and 0 - 9. Additionally .
(period), or - (hyphen) may be used. Pay close attention to the buttons you press, because the characters are not displayed on the screen. Asterisks are displayed instead (as if entering a password on a computer). 5 Use 123 to switch to the input of numbers. 6 Use text. ABC to switch back to the input of 7 Use to backspace and correct a mistake. 8 Touch touch any changes. to save this Administrator ID, or to exit this menu without saving 85 Meter Setup
****|
A Repeat Administrator ID B G L Q V C H M R W E J O T Y D I N S X 123 F K P U Z 9 Enter the Administrator ID again (the onscreen keypad is automatically dis-
played again) to confirm the first entry. Touch Administrator ID is now set), or to save this entry, (the to exit this menu, the Touch Administrator ID is not set and is therefore still inactive. The display automatically returns to the Setup-ID Setup menu. After you exit the Setup menu, only an authenticated administrator may set up any further IDs. 86 Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling Enter Administrator ID E J O T Y C H M R W D I N S X 123 ID Setup Lockout
****|
Optional Screens A B 04/19/2015 G L Q V F K P U Z Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2015 Meter Setup Changing an existing Administrator ID:
1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 Using the onscreen keypad, enter the valid Administrator ID. The ID Setup is displayed. The Adminis-
trator ID button is highlighted, which means an Administrator ID is active. 4 Touch Administrator ID and use the onscreen keypad to enter a new ID of choice (enter it twice). 87 Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling ID Setup 04/19/2015 Setup - ID Setup Administrator ID Operator ID Patient ID
|
04/19/2015 F K P U Z A F K P U Z 88 Enter Administrator ID Lockout
****|
Optional Screens A B G L Q V C H M R W D I N S X 123 Enter Administrator ID B G L Q V C H M R W D I N S X 123 Disabling an existing Administrator ID:
1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 Using the onscreen keypad, enter the valid Administrator ID. The ID Setup is displayed. The Adminis-
trator ID button is highlighted, which means an Administrator ID is active. 4 Touch Administrator ID. 5 Touch to close the onscreen keypad without entering an ID number. The Administrator ID has been deleted and therefore deactivated. The Adminis-
trator ID button is no longer highlighted. E J O T Y E J O T Y Meter Setup Operator ID In the default setting, the Operator login is not activated. You can either activate or deactivate Operator login on the meter. If activated, an Operator has to log in before the Main Menu will be displayed and measurements can be performed. Without a list, operators can log in directly by entering their operator name. This setup menu allows you to select whether or not an operator login is possible or required. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - ID Setup 04/19/2015 Administrator ID Operator ID Patient ID Select Operator ID Off Optional Required Scan Only 04/19/2015 04/19/2015 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 From the Setup-ID Setup menu, touch Operator ID. You may select from the following options:
Off (Operator ID cannot be entered) Optional (Operator ID can be entered, but is not required) Required (An Operator ID must be entered) Scan Only (An Operator ID must be scanned) 4 Touch the button with the setting of choice. Your selection is now highlighted. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen or (depend-
ing on the option you selected) proceeds to the next screen. The entries for the option Off are now completed. For the options Optional and Required, continue by selecting the input format. 89 6 Select the form for input of the Operator ID. You may select from the following options:
Alphanum. (alphanumeric) Enter any combination of A - Z and 0 - 9. Additionally . (period), or - (hyphen) may be used. Numeric Enter numbers only, e.g., 3387 Max. Length Enter the maximum number of characters
(1 20) the Operator ID can have. 7 Touch the button with the form of choice for setting up the Operator ID. Your selec-
tion is now highlighted. 8 Touch or to set the number of characters (length) of choice. 9 Touch to save this setting, or touch to exit this menu without saving any changes. The meter automatically returns to the Setup-ID Setup menu. Meter Setup Operator ID Alphanum. Numeric Max. Length:
20 04/19/2015 90 Meter Setup If you want to create a list of Operator IDs from which you can select an operator, additional software (a data management system) and a WLAN connection or the Handheld Base Unit are required (for more details see Data handling, starting on page 159). With an Operator list being transferred to the meter, the Operator ID options are different from the options in standalone mode. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 From the Setup-ID Setup menu, touch Operator ID. You may select from the following options:
List (Operator ID must be selected from the list or scanned using the barcode scanner) None (Operator ID cannot be entered or selected) Hidden List (Operator ID must be entered using the barcode scanner or the onscreen keypad) 4 Touch the button with the setting of choice. Your selection is now highlighted. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - ID Setup 04/19/2015 Administrator ID Operator ID Patient ID Select Operator ID None List Hidden List 04/19/2015 04/19/2015 91 Meter Setup Patient ID Patient IDs help you to assign stored results to individual patients. In the default setting, input of Patient IDs is set to No. This means that a consecutive number is assigned to each test. However, you can require that a Patient ID must be entered or make it optional. If you want to create a list of Patient IDs from which you can select a patient for testing, addi-
tional software (a data management system) and a WLAN connection or the Handheld Base Unit are required (see page 159). 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch ID Setup. 3 From the Setup-ID Setup menu, touch Patient ID. You may select from the following options:
Off (Patient ID cannot be entered) Optional (Patient ID can be entered, but is not required) Required (The operator must enter the Patient ID) Hidden List (Only available when work-
ing with a DMS. The list will not be shown. The operator needs to enter the Patient ID manually or via barcode scan.) 4 Touch the button with the setting of choice. Your selection is now highlighted. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen or (depend-
ing on the option you selected) proceeds to the next screen. The entries for the option Off are now completed. For the options Optional and Required, continue by selecting the input format. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - ID Setup 04/19/2015 Administrator ID Operator ID Patient ID Select Patient ID Off Optional Required Hidden List 04/19/2015 04/19/2015 92 Patient ID Alphanum. Numeric Max. Length:
20 04/19/2015 Meter Setup 6 Select the form for input of the Patient ID before each test. You may select from the following options:
Alphanum. (alphanumeric) Enter any combination of A - Z and 0 - 9. Additionally . (period), or - (hyphen) may be used. Numeric Enter numbers only, e.g., 3387 Max. Length Enter the maximum number of characters
(1 20) the Patient ID can have. 7 Touch the button with the form of choice for the Patient ID. Your selection is now highlighted. 8 Touch or to set the number of characters (length) of choice. 9 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the Setup-ID Setup menu. 93 Meter Setup 3.4 Lockout setup The Lockout menu contains the options for quality control tests that the operator is required to perform at specified intervals or based on specific triggers. This is a list of the available lockout options:
Operator Lockout QC Settings, containing New Lot Lockout QC Lockout IQC Lockout Custom Range Trop T Cleaning Lockout STAT Test Config. (overriding a lockout in an emergency situation) If the quality control test is not performed as required or if the result is outside the target value range, the meter, parameter or test strip lot is locked from further use. Lockouts can also be set up on an operator-specific basis, i.e., each operator must perform the corresponding quality con-
trol tests at specified intervals. A quality control test must be completed successfully before the meter is made available again
(either to the operator or in general) for testing. The option of setting up lockouts for operators is available only when the meter is set up for operator logins (see page 89) and operator lists are stored in the meter. In case of an emergency, there may not be the time to first complete the required quality control test if a lockout has been triggered and the meter is "locked". For such cases you may set up so-
called STAT Tests (STAT = Short TurnAround Time). This option allows to perform a limited number of tests when an operator lockout or QC lockout is in force. However, once the defined number of STAT tests has been performed, further use of the meter is no longer possible (for the affected test parameter or operator), unless the required quality control test is successfully completed. STAT tests cannot be performed if IQC lockout is in place or a new lot has not (yet) passed a quality control test (New Lot Lockout). 94 Meter Setup Operator lockout To perform a test with the meter, the individual steps must be performed properly. Quality control tests can be performed on a regular basis by every operator to ensure these steps are performed properly. By activating the operator lockout, operators are required to perform regular quality control tests. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch Operator Lockout. If this button appears in gray (inactive), the option Operator ID is deactivated. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup - Lockout Operator Lockout QC Settings Cleaning Lockout STAT Test Con g. 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2015 95 4 Select the time interval of choice in which the required quality control tests must be performed. You may select from the following options:
No (deactivated) Daily Weekly Monthly Every 3 or 6 months Yearly 5 Touch or to display the option of choice on the screen. If the arrow is just an outline options are available in the direction indi-
cated.
, this means no other 6 Touch the button to select the time interval of choice. Your selection is now high-
lighted. 7 Touch to save this setting, or touch to exit this menu without saving any changes. If you selected No, Operator Lockout is deac-
tivated. Meter Setup Select Operator Lockout No Daily Weekly Monthly Every 3 Months 04/19/2015 96 Meter Setup 8 Quality control tests may include one or two levels. Select the number of levels which must be performed (not applicable, if you selected No). 9 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the Setup-Lockout menu. Select Operator Lockout No of Levels One Level Two Levels 04/19/2015 97 Meter Setup Quality control (QC) settings QC Settings define that operator-independent quality control tests must be run on a regular basis. Lockouts may be triggerd by selectable time periods, and lockouts may be triggered by certain events. The QC Settings menu contains the following options:
QC Lockout (time-based), with the additional option of a New Lot Lockout (applies every time a new test strip lot is used) IQC Lockout (time-based) Custom Range Trop. T (customize the QC Range in accordance with applicable local guidelines) QC Result Format (select the format for QC result displays) Reset Test Param. (reset all test parameters, including code chip data and QC lockouts) 98 Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup - Lockout Operator Lockout QC Settings Cleaning Lockout STAT Test Con g. 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2015 Setup - QC Settings QC Lockout IQC Lockout QC Result Format Custom Range Trop. T Reset Test Param. 04/19/2015 Meter Setup 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch QC Settings. 99 Meter Setup Quality control (QC) lockout A QC Lockout requires a quality control test to be performed. You may also set the number of levels for this test. You may select from the following options:
New Lot: Yes/No (applies every time a new test strip lot is used) The general intervals are:
No Daily Weekly Monthly All enabled QC Lockouts, if the time period has elapsed, are activated at 8:00 a.m. (default set-
ting, time can be changed with a DMS). See page 99 on how to access the Setup-QC Settings menu. Setup - QC Settings Setup - Lockout 09:15 am QC Lockout IQC Lockout QC Result Format Custom Range Trop. T Reset Test Param. New Lot:
Yes No No Daily Weekly Monthly 04/19/2015 04/19/2015 1 Touch QC Lockout to set regularly recur-
ring quality control tests for available test parameters. 2 New Lot: Touch Yes if you want to force a control test every time a new test strip lot is used. Otherwise touch No. 3 Time intervals: Touch the button to select the time interval of choice (e.g., Daily). Your selection is now highlighted. 4 Touch to save this setting, or touch to exit this menu without saving any changes. 5 Quality control tests may include one or two levels. Select the number of levels which must be performed (not applicable, if you selected No). 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 100 Instrument quality control (IQC) lockout An IQC Lockout also requires a quality control test with dedicated IQC test strips to be per-
formed. You may select from the following options:
Meter Setup No Daily Weekly Monthly All enabled IQC Lockouts, if the time period has elapsed, are activated at 8:00 a.m. (default set-
ting, time can be changed with a DMS). See page 99 on how to access the Setup-QC Settings menu. Setup - QC Settings Select IQC Lockout QC Lockout IQC Lockout QC Result Format Custom Range Trop. T Reset Test Param. No Daily Weekly Monthly 04/19/2015 04/19/2015 1 Touch IQC Lockout to set regularly recur-
ring instrument quality control tests (IQC
= Instrument Quality Control). 2 Touch the button to select the time interval of choice. Your selection is now high-
lighted. 3 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 101 Meter Setup QC result format The QC Result format defines the kind of information that is displayed in a QC result screen. You may select from the following options:
Display without a value, but with text Pass or Fail Display a value Display as value and with text Pass or Fail See page 99 on how to access the Setup-QC Settings menu. Setup - QC Settings Select QC Result Format 1 Touch QC Result Format to set the dis-
QC Lockout IQC Lockout Pass/Fail Value QC Result Format Value & Pass/Fail Custom Range Trop. T Reset Test Param. 04/19/2015 04/19/2015 play format. 2 Touch the button to select the result format of choice. Your selection is now highlighted. 3 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 102 Meter Setup Custom Range Troponin T The quality control range for Troponin T can be customized to comply with local guidelines. The Custom Range Trop. T function enables you to narrow the default range. Default Range: The meter displays the quality control range provided by Roche in the code chip. Custom Range: The option Custom Range lets the user define their own quality control range within the default range. See page 99 on how to access the Setup-QC Settings menu. Setup - QC Settings Custom Range Trop. T 1 Touch Custom Range Trop. T to set the QC Lockout IQC Lockout quality control range. Default Range You may select from the following options:
QC Result Format Custom Range Custom Range Trop. T Reset Test Param. 04/19/2015 04/19/2015 Default Range (Range provided in the code chip is selected and displayed.) Custom Range (The allowed percentage deviation from target value can now be customized). 2 Touch the button with the setting of choice. Your selection is now highlighted. If you selected Default Range, touch to save this setting, or touch menu without saving any changes. to exit this If you selected Custom Range, touch to proceed with corresponding settings, or touch to exit this menu without saving any changes The display automatically returns to the previous screen. 103 Meter Setup Custom Range Trop. T Custom Range Trop. T Default Range Custom Range Deviation from target value (in %):
21 04/19/2015 04/19/2015 If you selected Custom Range, the Custom Range screen opens and offers you the option of customizing the deviation from target value
(percentage value). For the control solutions, the target value always comes from the information stored in the code chip. If you have chosen Custom Range, you can now select an allowed devia-
tion from target value in the range of 0 to 50%
(in the illustration, 21%). 3 Use the arrows to to set the allowed per-
centage deviation from the target value. to save this setting, or touch Touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 104 Meter Setup Reset test parameters Under certain circumstances, it may be necessary to delete the test parameters stored in the meter (for example, if a lockout exists for a test strip lot that is no longer available). However, do not use this method for overriding lockouts in general because, after resetting the test parame-
ters, the meter may go into a QC lockout (if configured). If the meter or a parameter is locked by a QC lockout or an operator lockout, use STAT tests for emergency tests. STAT tests cannot be performed if IQC lockout is in place or a new lot has not (yet) passed a quality control test (New Lot Lockout). See page 99 on how to access the Setup-QC Settings menu. Setup - QC Settings Reset Test Parameter QC Lockout IQC Lockout QC Result Format Custom Range Trop. T Reset Test Param. Do Reset No Reset 04/19/2015 04/19/2015 4 Touch Reset Test Param. to reset all stored test parameters and QC lockouts. 5 Select Do Reset and confirm by to reset the test parameters, touching to exit without resetting the or touch test parameters (this leads to the same result as selecting and confirming No Reset). The display automatically returns to the previous screen. 105 Meter Setup Cleaning lockout Under normal handling conditions, your meter will not be exposed to significant dirt or contami-
nation. However, circumstances might require regular checks of the test strip guide and (when necessary) cleaning of the meter. The Cleaning Lockout allows operators to specify time intervals for cleaning. 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch Cleaning Lockout. You may select from the following options:
No Daily Weekly Monthly 4 Touch the button to select the time interval of choice. Your selection is now high-
lighted. 5 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup - Lockout Operator Lockout QC Settings Cleaning Lockout STAT Test Con g. 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2015 Select Cleaning Lockout No Daily Weekly Monthly 04/19/2015 106 Meter Setup STAT test configuration Quality control tests ensure consistent quality and accurate measurements. In emergency situa-
tions, however, it may be necessary to perform a test without delay. To override an active lockout for a test parameter, lot or operator, you can allow for STAT Tests (STAT = Short TurnAround Time). STAT tests cannot be performed if IQC lockout is in place or a new lot has not (yet) passed a quality control test (New Lot Lockout). You can set a number of tests permitted beyond the lockout. Once the number of allowed STAT Tests has been reached (for a single parameter), additional tests for this parameter are locked until you successfully perform a quality control test. STAT Tests will be counted separately for each test parameter. Thus the actual availability of STAT Tests may differ for each parameter. STAT tests are labelled accordingly in the result window. 107 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch STAT Test Config. 4 Touch Enable to allow STAT Tests or:
Touch Disable to prohibit STAT Tests. Your selection is now highlighted. 5 If you have enabled the option, touch to set the number of additional tests. or 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup - Lockout Operator Lockout QC Settings Cleaning Lockout STAT Test Con g. 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2015 STAT Test Enable Disable 3 Quantity:
04/19/2015 108 3.5 Optional Screens setup In this screen, you can customise display formats and test procedures. You can choose to display additional information and select from options for managing the result display. Meter Setup 1 From the Main Menu, touch Setup to open the meter settings. 2 From the Setup menu, touch Optional Screens. In this menu screen, you may select from the following options:
Display additional information on meter status Select to display results only after new login by operator Enable operators to confirm or reject test results Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2015 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - Optional Screens Start Info Result Login Result Con rmation 04/19/2015 04/19/2015 109 Meter Setup The additional status information is displayed after powering on the meter or after logging off as an operator. This includes information about current lockouts, the number of results not trans-
ferred (to the DMS) and the time since the last data transfer. Setup - Optional Screens Start Info Screen 3 Touch Start Info. Start Info Result Login Result Con rmation Enable Disable 04/19/2015 04/19/2015 4 Touch the button to select the state of the status display. Your selection is now high-
lighted. 5 Touch to save this setting, or touch to exit this menu without saving any changes. In environments with multiple operators, it can be useful to display a test only if the operator carrying out the test is present. By requiring operators to login again before displaying results, you ensure that only authorised persons view the results. Setup - Optional Screens Result Login Screen 6 Touch Result Login. Start Info Result Login Result Con rmation Enable Disable 04/19/2015 04/19/2015 7 Touch the button to select the state of the option. Your selection is now highlighted. 8 Touch to save this setting, or touch to exit this menu without saving any changes. 110 In some circumstances, it may be useful for operators to confirm the validity of their results. To do so, an option can be enabled that prompts operators to confirm the results of every test. Setup - Optional Screens Res. Con rmation Screen 9 Touch Result Confirmation. Meter Setup Start Info Result Login Result Con rmation Enable Disable 04/19/2015 04/19/2015 10 Touch the button to select the state of the option. Your selection is now highlighted. 11 Touch to save this setting, or touch to exit this menu without saving any changes. 111 Meter Setup This page intentionally left blank. 112 Performing a Test 4 Performing a Test What you need:
Suitable blood sampling system to collect venous whole blood Only heparinized blood collection tubes are allowed. Refer to test strip package insert. cobas h 232 meter Roche CARDIAC test strips for the desired test, with the supplied code chip Roche CARDIAC pipettes (or other suitable pipettes with pipetting volume of 150 L) for applying the sample to the test strip The Roche CARDIAC family includes several strips. Always ensure that the disposables you are using (e.g., test strips) are intended for use with the cobas h 232 meter. Some tests might require a minimum software version. Ensure that the software version on the cobas h 232 meter is compatible with the test you are running (refer to the corresponding package insert for details). Contact your Roche representative if the cobas h 232 meter requires a software update. Always operate the meter according to the specified operating conditions (see page 177). follow the information on correct handling of test strips in the package insert. place the meter on a level, vibration-free surface when applying the sample to the sample application area of the test strip. Once the sample has been completely absorbed by the test strip, you can move the meter. keep the meter clean. See Maintenance and Care on page 165. 113 Performing a Test Never use Roche CARDIAC pipettes for collecting blood from the patient. touch or remove the test strip during a test. add more blood after the test has begun. remove or insert the code chip while the meter is performing a test. move or pick up the meter while applying the sample - wait until the necessary sample has been absorbed completely by the test strip. store the meter at extreme temperatures. store the meter in damp or humid conditions without protection. store the meter in a dusty environment witout protection. Accuracy/precision of measured results:
CAUTION Failure to comply with the above may lead to inaccurate results. An incor-
rect result may lead to an error in diagnosis, therefore posing danger to the patient. 114 Performing a Test Sample material Heparinized venous whole blood is used as sample material. For each test use exactly 150 L of sample. Use a suitable sampling system to collect the blood sample. Use only heparinized blood collec-
tion tubes. Do not use blood collection tubes containing EDTA, citrate, sodium fluoride or other additives. For details refer to the test strip package insert. IMPORTANT NOTE: Never use Roche CARDIAC pipettes for blood sampling directly from the vein nor for administering injections. They are not sterile-packaged and do not contain anti-
coagulants. Roche CARDIAC pipettes are intended only for drawing the sample from the blood collection tube and applying it to the test strip. See page 129. Observe the applicable regulations and directives for hygiene and safety when collecting blood samples. Observe the applicable regulations and directives for disposing of potentially infectious samples and materials. Dispose of used consumables in line with the disposal policy of your hospital, institute or medical practice. See safety message Protection against infection and blood-borne pathogens on page 15. 4.1 Preparing to test 1 Prepare the required test strips (shown here: Roche CARDIAC POC for testing Troponin T). 2 Make sure that the code chip supplied with these test strips is also at hand. 115 Performing a Test Code chip The code chip provides the meter with important information on the manufacturer-specific parameters of the respective test strip lots. It contains information about the test method, the lot number and the expiration date. Pat. Test - Ins. Chip Par:
proBNP Insert Code Chip 04/19/2015 Each test strip box contains its own code chip. Make sure you have the code chip at hand before performing the first test with a new test strip lot. When you insert a test strip from a new lot for the first time, the meter prompts you to insert the corresponding code chip. At this point, compare the code number you see on the display with the number that is printed on the test strip package you are using. If the two code numbers are identi-
cal, insert the new code chip into the slot in the meter. Once inserted, the code chip information is read and stored on the meter. The meter can store up to 200 code chip datasets
(100 test strip lots and 100 quality control lots). Further tests using the same strip lot can be performed without inserting the code chip again. The code chip is no longer required, once the data is stored. You may leave it in the meter, or you can use it with other meters using the same test strip lot. 116 Performing a Test Roche recommends keeping the code chip in the meter to protect the contacts from becoming dirty. Protect the code chip from moisture and equipment which produces magnetic fields and electrostatic discharges. Once the test strip lot is used up, dispose of the old code chip promptly to prevent mix-ups. Inserting the code chip 1 Remove the old code chip, if one is inserted in the meter. 2 Always make sure that the number on the code chip matches the number on the label of the test strip package. By scanning the barcode on the strip, the meter gathers information about the number of the required code chip. 3 Slide the new code chip into the slot on the top of the meter as shown until you feel it snaps into place. If the code chip does not match the test strip lot, is missing or incorrectly inserted, an error message appears in the display (see Troubleshooting starting on page 173). 117 Performing a Test Test steps (overview) The following illustration shows the steps performed during testing. The steps you actively per-
form are displayed with a dark background. Depending on the configuration, the individual steps shown here may include additional actions (e.g., entering a password). Some steps may be dif-
ferent, working with or without Operator IDs and Patient IDs. On the following pages these steps are explained separately for each configuration. 1 2 3 Without operator and patient lists (or both operator and patient ID disabled) With operator list (or operator ID enabled) With operator and patient list (or operator and patient ID enabled) 1 2 3 Powering on Powering on Powering on Self-check Self-check Self-check Main menu Log in/list Log in/list Patient test Main menu Main menu Test strip Patient test Patient test Test strip Patient ID/list Sample Result Test strip Sample Result Sample Result 118 Powering on the meter Performing a Test 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the power adapter or by placing the meter on the Handheld Base Unit. The meter performs a self-check at startup. 119 Self-Check 09:15 am Self-Check 09:15 am Performing self-checks... SW Version: 04.00.00 Self-checks complete. 04/19/2015 SW Version: 04.00.00 04/19/2015 Performing a Test Logging in The initial steps until the Main Menu is displayed depend on the configuration and are performed as follows:
Without operator login required Main Menu 09:15 am 2 Wait until the main menu is displayed. Patient Test Control Test Review Results Setup 04/19/2015 With operator login (no operator list) 2 Enter or scan your Operator ID. 3 Touch to confirm your entry. 4 Wait until the main menu is displayed. Operator ID SC123 B A E J O T Y C H M R W
, D I N S X 123 Scan G L Q V F K P U Z 120 With operator login (list available) Select Operator ID 09:15 am 2 If an operator list exists, wait until this list Performing a Test OP003 Hall, Molly-Jessica OP001 Hughes, Adam OP002 Patel, Al e-Adam Scan 04/19/2015 is displayed. 3 Touch or to scroll through the list. Select the operator of choice by touching the corresponding button. As an alternative (meters with a scanner), the operator login can be performed via the built-
in barcode scanner. Touch Scan and hold the card with the barcode approx. 10-20 cm
(4-8 in) from the scanner. It is not possible to connect an external bar-
code scanner to the meter. 121 4 Enter the password. 5 Touch to confirm your entry, or touch to display the operator list again. 6 Wait until the main menu is displayed. When the tests are completed or another operator wants to perform additional tests, touch Logout to log out. The meter returns to the display of the operator list. Performing a Test
****|
A F K P U Z Password B G L Q V C H M R W E J O T Y D I N S X 123 Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 04/19/2015 122 4.2 Performing a test Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 04/19/2015 Main Menu 09:15 am QC Lockout Main Menu 09:15 am Control Test Review Results Setup Logout Clean Meter 04/19/2015 Cleaning Lockout Cleaning Review Results Setup 04/19/2015 Remove Cover 04/19/2015 Main Menu 09:15 am QC!
Patient Test Control Test Review Results Setup Logout 04/19/2015 Performing a Test 1 Check the charge level of the battery pack. If there are no bars left in the battery icon, you cannot perform any more tests. 2 Check that the date and time are correct. Correct any incorrect settings as described in the chapter entitled Meter Setup/Setting the date. If a QC lockout is displayed instead of Patient Test, you must run a quality control test before you can perform a test (see Control Testing and Quality Control starting on page 137). If the meter is locked, a test can only be performed as a STAT test (if this func-
tion is enabled and if there are still STAT tests available). If a Cleaning Lockout is displayed instead of Patient Test, you must touch Cleaning and follow the instructions on the screen and clean the meter. See Maintenance and Care beginning on page 165. Once you have re-
attached the test strip guide cover and pow-
ered the meter on again, the meter is no longer locked. If the Patient Test button is available, but a lockout is displayed, you must first perform a quality control test for certain test parameters. Other test parameters are not affected. 123 Performing a Test Without patient list 3 Touch Patient Test. Patient ID PID111SCHULZM457 A F K P U Z E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan 4 If you selected the Patient ID as optional, you can enter or scan a Patient ID. If you selected the Patient ID as required, you must enter or scan the Patient ID. If you selected no Patient ID (None), the meter automatically proceeds to the next step. 5 Touch to confirm the ID, or touch to cancel the ID entry. Continue reading on page 127. 124 With patient list Performing a Test 3 Touch Patient Test. Patient lists can only be created on a DMS and must be transferred to the meter. Lists cannot be created on the meter. Select Patient ID PID001GERTA123 Anders, Gert PID001BERNDH123 Bernd, Hans PID001CHAPLINC123 Chaplin, Charlene PID001FRENZENA12 Frenzen, Alice PID230ONEALJ1234 ONeal, John New Scan 04/19/2015 Patient ID PID111SCHULZM457 A F K P U Z E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan 4 Touch or to scroll through the list. Select the patient to be tested by touching the corresponding button. 5 If the patient is not in the list, touch New to create a new entry. You must now enter a Patient ID manually or scan it using the barcode scanner. 125 Performing a Test Select Patient ID PID001GERTA123 Anders, Gert PID001BERNDH123 Bernd, Hans PID001CHAPLINC123 Chaplin, Charlene PID001FRENZENA12 Frenzen, Alice PID230ONEALJ1234 ONeal, John New Scan 04/19/2015 The Patient ID can also be entered via bar-
code (meters with a barcode scanner only). Touch Scan and hold either a card with the barcode approx. 10 cm from the scanner or the meter over a patient bracelet. The scanner is also active, once you open the Enter Patient ID screen using the New button
(for approx. 10 seconds). 126 Inserting a test strip Pat. Test - Ins. Strip PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM Pat:
Op:
Insert Strip 04/19/2015 Performing a Test 1 The test strip icon prompts you to insert a test strip. Remove the test strip from its foil pouch. 2 Hold the test strip so that the application area and test area are facing up. 3 Hold the test strip straight and flat. Insert it in the test strip guide of the meter. Be careful that the strip is not shifted, angled or tilt during insertion. It is also important that you insert the test strip using one smooth movement. Inserting the test strip too slowly or too fast can cause a barcode reading error. Slide the test strip in as far as it will go. A beep tone indicates that the meter has detected the test strip (provided the beeper is enabled). Exposure to external influences (e.g., humidity) may deteriorate the test strips and may lead to error messages! Remove the test strip from its foil pouch only when you are ready to perform a test. 127 Performing a Test Pat. Test - Ins. Chip Par:
proBNP Insert Code Chip 04/19/2015 If you use a new test strip lot, you must insert the corresponding code chip once. See Code chip on page 116. Depending on the meter setting, you may also be required to run a quality control test at this point. The meter identifies the required code chip based on the test strip barcode and displays the code number. For each test parameter and each new test strip lot a different code key number is displayed. The thermometer icon shows that the test strip is warming up. A beep tone indicates when the warming-up process is complete
(provided the beeper is enabled). The pipette icon indicates that the meter is ready to perform the test and is waiting for blood to be applied. Simultaneously, a 5-minute countdown begins. You must apply the sample within this time. Otherwise you will receive an error message (after the sample detection has timed out). The test strip is now unusable, repeat the test with a new test strip. In case of errors, see Troubleshooting on page 173. Pat. Test - Warming Up Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Please Wait Warming Up 04/19/2015 Pat. Test - App. Sample Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 150 L Apply Sample 4:10 Min 04/19/2015 128 Performing a Test 4 Using the Roche CARDIAC pipette, draw exactly 150 L (to the blue mark on the pipette) heparinized blood from the blood collection tube. Make sure the sample contains no air bubbles. 1 5 0 L 5 Apply the entire sample to the sample application area of the test strip. Always place the meter on a level, vibration-
free surface when applying the sample to the sample application area of the test strip. Once the sample has been completely absorbed by the test strip, you can move the meter. 6 Touch to confirm that the sample has been applied. The hourglass icon appears as the meter begins to process the sample. For better control over the measurement process, you should always confirm this yourself, instead of waiting for the meter to detect the sample. After you confirm that the sample has been applied, or if the meter automatically recog-
nises that the sample has been applied, the button disappears. 129 Performing a Test Pat. Test - Measuring Pat:
SCHULZ, MANFRED Op:
Par:
JONES, TOM proBNP Code:
PB1234 10:20 Min 04/19/2015 The hourglass icon spins until the sample has been detected and the test begins. The time remaining for the test is displayed. Measurement time:
The time needed to run a test depends on the test parameter (refer to package insert for details). Typically, 8 to 12 minutes are required. Do not add more blood. Do not touch the test strip until the result is displayed. Pat. Test - Measuring Pat:
SCHULZ, MANFRED Op:
Par:
JONES, TOM Trop T Code:
TT 2721 10:20 Min TnT Elevated 04/19/2015 For Troponin T only:
As soon as the meter detects a signal (this may take a few minutes), a qualitative result
(TnT Elevated) appears under the hourglass icon (see illustration). The quantitative result is displayed when the test is completed. Refer to the Roche CARDIAC T Quantitative or Roche CARDIAC POC package insert for more details. 130 Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
01/25/2015 10:17 620 pg/ml 04/19/2015 Performing a Test The test result is shown and stored automati-
cally. When interpreting your result, please read the test strip package insert carefully. Print button:
Print results (infrared interface) QR Code button:
Display result as QR code Menu button:
Return to main menu Comment button:
Add predefined or custom comments to the test result 7 Remove the test strip from the meter. 8 Power the meter off by pressing the button for approximately 1 second if you do not wish to perform any further tests. 9 Discard the used disposable item and test strip in compliance with the disposal policy of your hospital or medical practice. 10 Clean the meter if necessary. See Main-
tenance and Care on page 165). 131 Performing a Test Displaying, confirming or adding comments to results As described in the chapter Optional Screens setup starting on page 109, there are many options for displaying results that can be activated:
If a new Operator Login is required to display the result:
1 Touch the button for Operator Login. 2 Log in as described on page 121. Pat. Test - Op. Login PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
Measurement Complete 04/19/2015 The result is now displayed. 132 Pat. Test - Con rm. PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
01/25/2015 10:17 620 pg/ml Measurement OK?
Reject Accept 04/19/2015 Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
01/25/2015 10:17 Rejected 04/19/2015 Performing a Test If the test result requires a confirmation:
When the result is displayed, touch the button to select the confirmation of choice. You can choose to either Reject Accept If you reject the result, the result value is no longer displayed. However, the test entry is stored. 133 Performing a Test You can add up to three comments to a test result. Comments can provide, for example, addi-
tional information about the test conditions or the patient. A comment may be up to 20 charac-
ters in length. You can open the function for adding comments directly in the results screen. If you want to add a comment, do not remove the test strip. Once the strip is removed, the meter automatically returns to Main Menu and a comment can no longer be added. Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
01/25/2015 10:17 620 pg/ml If you want to add a comment to a test result:
1 In the result screen, touch
. 2 Select a predefined comment from the list and/or 3 Touch Custom to enter your own com-
ment using the onscreen keypad. Pat. Test - Comment Symptomatic Asymptomatic Chest Pain Dyspnea 04/19/2015 Custom The comments are stored with the test result. 04/19/2015 Pat. Test - Result TESTER User1 Trop T Code:
TT 2721 Pat:
Op:
Par:
01/25/2015 10:17 620 pg/ml Symptomatic Chest Pain Test 04/19/2015 134 Performing a Test Displaying the test result as QR code The QR code button only appears if the QR code display function is activated (see page 65 and following). Otherwise it is not displayed. 1 2 Touch code. Touch result display. to display the result as QR to return to the standard The size of the QR code displayed on the screen varies according to the amount of data encoded. 135 Performing a Test STAT tests STAT tests are a limited number of tests that can be performed in emergency situations, see page 107. If the meter is configured to perform STAT tests, you have the option of performing a test by choosing STAT even though a QC Lockout is in place. 1 To perform the measurement without performing a quality control test, touch STAT, or:
2 Touch to perform the quality control test before the measurement. When a STAT test is performed, this infor-
mation is stored with the result. The number of permissible STAT tests is reduced by 1. After all pending quality control tests are performed, the specified number of STAT tests is available again in case of a new lockout. Pat. Test - Lockout PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
Test Parameter Locked!
Please Perform QC. STAT 04/19/2015 Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
01/25/2015 10:17 620 pg/ml STAT Test 04/19/2015 136 5 Control Testing and Quality Control Control Testing and Quality Control The cobas h 232 POC system employs several methods to check that the meter and test strips are working properly and that the operator is performing the test correctly. The meter has a number of built-in quality control functions:
A self-check of the electronic components and functions every time the meter is powered on. A check of test temperature when warming up and during the test. A check of the expiration date and lot information on the test strip using the information from the code chip. In addition, the cobas h 232 POC system provides:
Configurable, prescribed quality control tests using Roche CARDIAC IQC test strips for internal functionality tests. Definable, prescribed control tests using Roche CARDIAC Control materials for the avail-
able test parameters. 5.1 Preparing to run a quality control test Prepare for a quality control test in the same way you would prepare to perform a test with a patient sample. The only difference is the use of control solution instead of blood. To perform a quality control test using control solutions, you need:
cobas h 232 meter Test strips for the desired tests, with the supplied code chip Roche CARDIAC pipettes (or other suitable pipettes with pipetting volume of 150 L) Control set containing two vials of Roche CARDIAC Control material and code chip 137 Control Testing and Quality Control Always refer to the package insert provided with the control material for specific handling and testing instructions. Reconstituted control material taken from the refrigerator must be allowed to reach room temperature before use. You can specify the frequency of quality control tests according to your own requirements (see Meter Setup/Lockout setup starting on page 94). If you encounter a lockout for a test strip lot that no longer exists, see Reset test parameters on page 105. Please note that, when you use this method, all saved test parameters and QC lock-
outs will be deleted. 138 Control Testing and Quality Control 5.2 Performing a quality control test Quality control (QC) 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the power adapter or by placing the meter on the Handheld Base Unit. Depending on the system settings the opera-
tor my have to log in and/or enter a password. Follow the procedures as described on page 121. Main Menu 09:15 am 2 Wait until the main menu is displayed. QC!
Patient Test Control Test Review Results Setup 04/19/2015 139 Control Testing and Quality Control Main Menu 09:15 am QC!
Patient Test Control Test Review Results Setup QC Test - QC Status QC Status CK-MB DDimer Myo proBNP Trop T
- Pass
- Pass
- Pass
- Locked
- Locked 04/19/2015 QC Test - Ins. Strip Op:
JONES, TOM 04/19/2015 Insert Strip 04/19/2015 3 Touch Control Test. 4 In the QC Status screen, touch to con-
tinue with the quality control test. 5 The test strip icon now prompts you to insert a test strip. Remove the test strip from its foil pouch. 6 Hold the test strip so that the application area and test area are facing up. 7 Hold the test strip straight and flat. Insert it in the test strip guide of the meter. Be careful that the strip is not shifted, angled or tilt during insertion. It is also important that you insert the test strip using one smooth movement. Inserting the test strip too slowly or too fast can cause a barcode reading error. Slide the test strip in as far as it will go. A beep tone indicates that the meter has detected the test strip (provided the beeper is enabled). Exposure to external influences (e.g., humidity) may deteriorate the test strips and may lead to error messages! Remove the test strip from its foil pouch only when you are ready to perform a test. 140 Par:
Op:
QC Test - Sel. QC Lot pro BNP Code:
PB1234 JONES,TOM Code PBC014 Code PBC016 Code PBC017 Code PBC018 New 04/19/2015 QC Test - Ins. Chip proBNP PBC014 JONES, TOM Code:
PB1234 Par:
QC:
Op:
QC Insert Code Chip PBC014 04/19/2015 Control Testing and Quality Control If you use a new test strip lot and have not inserted the code chip yet, you must do so now. Otherwise you cannot perform a quality control test. As with the test strips, a code chip is also pro-
vided with the control materials. The informa-
tion on the code chip is stored in the memory so you can use the same control materials again at any time. 8 Select the code stored for your current control material, or touch New to use a new control material. If you are using a new control material, remove the code chip from the meter and insert the code chip that came with the control material instead. 141 9 If the control material box contains more than one level, select the level of choice for this measurement. The thermometer icon shows that the test strip is warming up. A beep tone indicates when the warming-up process is complete
(provided the beeper is enabled). The pipette icon indicates that the meter is ready to perform the test and is waiting for the sample to be applied. Simultaneously, a 5-minute countdown begins. You must apply the sample within this time, otherwise you will receive an error message (after the sample detection has timed out). In case of errors, see Troubleshooting on page 173. Control Testing and Quality Control QC Test - Sel. QC Level PB1234 Code:
proBNP PBC014 JONES, TOM Par:
QC:
Op:
Level 1 Level 2 04/19/2015 QC Test - Warming Up Par:
QC:
Op:
proBNP, PBC014 JONES, TOM PB1234 Code:
Level: 1 Please Wait Warming Up 04/19/2015 QC Test - App. QC proBNP PBC014 JONES, TOM Code:
Level: 1 PB1234 Par:
QC:
Op:
150 L Apply QC 4:10 Min 04/19/2015 142 Control Testing and Quality Control 10 Using the pipette, draw up the dissolved contents of the vial. 11 Apply the sample (exactly 150 L) to the application area of the test strip. Always place the meter on a level, vibration-
free surface when applying the sample to the sample application area of the test strip. Once the sample has been completely absorbed by the test strip, you can move the meter. 12 Touch to confirm that the sample has been applied. The hourglass icon appears as the meter begins to process the sample. For better control over the measurement process, you should always confirm this yourself, instead of waiting for the meter to detect the sample. 13 After you confirm that the sample has been applied, or if the meter automatically recognises that the sample has been applied, the button disappears. The hourglass icon spins until the sample has been detected and the test begins. Unlike regular tests, this procedure can be very short and therefore might not be dis-
played (especially in case of a lack of or delay in confirmation, see step 12). 143 QC Test - Processing Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 Processing... 04/19/2015 The time remaining for the test is displayed. Measurement time:
The time needed to run a test depends on the test parameter (refer to package insert for details). Typically, 8 to 12 minutes are required. The result of this quality control test is dis-
played and is automatically saved to memory. The target value and the range in which the results for this control material should be located is displayed below the current result. If a quality control test fails, an up arrow (too high) or down arrow (too low) is displayed. There are three options for displaying a QC test result:
Pass/Fail Value Value & Pass/Fail For details refer to QC result format on page 102 and Settings summary on page 47. Control Testing and Quality Control QC Test - Measuring Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 10:20 Min 04/19/2015 QC Test - Result proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 Par:
QC:
Op:
Par:
QC:
Op:
QC Test - Result proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 01/25/2015 10:17 01/25/2015 10:17 Pass:
329 pg/ml Fail:
490 pg/ml
(350 / 300-400 pg/ml)
(350 / 300-400 pg/ml) 04/19/2015 04/19/2015 144 Control Testing and Quality Control Print button:
Print results (infrared interface) QR Code button:
Display result as QR code Menu button:
Return to main menu Comment button:
Add predefined or custom comments to the test result 14 Remove the test strip from the meter. 15 Power the meter off by pressing the button for approximately 1 second if you do not wish to perform any further tests. 16 Discard the used disposable item and test strip in compliance with the disposal policy of your hospital or medical practice. 17 Clean the meter if necessary (see Main-
tenance and Care on page 165). 145 Control Testing and Quality Control Displaying the QC result as QR code The QR code button only appears if the QR code display function is activated (see page 65 and following). Otherwise it is not displayed. 1 2 Touch code. Touch result display. to display the result as QR to return to the standard The size of the QR code displayed on the screen varies according to the amount of data encoded. 146 Control Testing and Quality Control Instrument quality control (IQC) The Roche CARDIAC IQC test serves as a performance check for the optical system of the cobas h 232 POC system. The instrument determines the reflectance value of the signal and displays Pass, Fail or the percentage of remission depending on your settings. Pass means that the optical system of the cobas h 232 POC system is functioning properly. If Fail appears, the measured reflectance value is outside the confidence interval. 1 Prepare the required IQC test strips
(shown here: Roche CARDIAC IQC high). 2 Make sure that the code chip supplied with these test strips is also at hand. 147 Control Testing and Quality Control The first steps in this quality control test are identical to the procedure described before, see page 139. The following description therefore starts at the main menu. Main Menu 09:15 am QC!
Patient Test Control Test Review Results Setup 04/19/2015 QC Test - Ins. Strip QC Test - QC Status QC Status CK-MB DDimer Myo proBNP Trop T
- Pass
- Pass
- Pass
- Locked
- Locked Op:
JONES, TOM 04/19/2015 3 Touch Control Test. 4 Touch in the QC Status screen to con-
tinue with quality control test. The test strip icon prompts you now to insert a test strip. 5 Remove the test strip from its IQC test strip container. 6 Insert the test strip as described before, see page 140. 7 If you are using a new lot of IQC test strips and have not inserted the code chip yet, you must do so now. If you have used the test strips already, skip this step. Insert Strip 04/19/2015 QC Test - Ins. Chip IQC Par:
Op:
JONES, TOM QC Insert Code Chip 702 04/19/2015 148 Par:
QC Test - Measuring IQC IQC702 Code:
Level: 1 Op:
JONES, TOM 04/19/2015 QC Test - Result Par:
IQC Op:
JONES, TOM Code:
Level: 1 IQC702 11/04/2015 10:17 83 %
(85 / 82 - 88 %) 04/19/2015 Control Testing and Quality Control The hourglass icon is displayed and the (inter-
nal) measurement begins. The result of this IQC quality control test is displayed as Pass or Fail (default setting) or in the format selected in the QC result format setting. There are three options for displaying an IQC test result:
Pass/Fail Value Value & Pass/Fail For details refer to QC result format on page 102 and Settings summary on page 47. 149 Control Testing and Quality Control This page intentionally left blank. 150 6 Review Results Review Results The cobas h 232 meter can save 2000 patient test results as well as 500 quality control tests to memory, together with time, date, lot number and, if applicable, IDs and comments. Reviewing test results 1 Power the meter on by pressing the button for approximately 1 second. You can also power on the meter directly by connecting the power adapter or by placing the meter on the Handheld Base Unit. Depending on the system settings the opera-
tor my have to log in and/or enter a password. Follow the procedures as described on page 121. Main Menu 09:15 am 2 Wait until the main menu is displayed. Patient Test Control Test Review Results Setup 04/19/2015 151 Review Results From the Main Menu you have access to all stored results, sorted by selectable criteria:
Patient History All Results QC Results (Quality Control) IQC Results (Instrument Quality Control) Maintenance History Main Menu 09:15 am Review Results 3 Touch Review Results. 4 Select the function you want to perform in the memory. Patient Test Control Test Review Results Patient History All Results QC Results IQC Results Setup Mainten. History 04/19/2015 04/19/2015 The print button only appears if the printer function is activated. Otherwise it is not dis-
played. The QR code button only appears if the QR code display function is activated. Otherwise it is not displayed. 152 Patient history This memory area contains a list of all patients, sorted by Patient ID. From here, you can call up results for any individual patient. Review Results Pat. History - Select ID PID001GERTA123 Anders, Gert PID001BERNDH123 Bernd, Hans PID001CHAPLINC123 Chaplin, Charlene PID001FRENZENA12 Frenzen, Alice PID230ONEALJ1234 ONeal, John Scan 04/19/2015 Single Patient Results Pat:
PID111SCHULZM457 SCHULZ, MANFRED DDimer 02/12/15 High 08:30 proBNP 02/08/15 620 pg/ml 09:49 DDimer 01/21/15 1.3 g/ml 09:15 Pat:
Op:
Par:
Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2015 02/08/2015 09:49 620 pg/ml New Strip Lot 04/19/2015 1 Touch or to display the entry of choice on the screen. If the arrow is just an outline
, you have reached the beginning or end of the patient list. 2 Touch the patient name whose results you want to open. 3 Touch or to display the test result of choice on the screen. 4 Touch the test result you would like to view in detail. 153 Review Results All results This memory area contains a list of all tests, sorted chronologically. From here, you can call up results for specific times. 1 Touch or to display the entry of choice on the screen. 2 Touch the patient name whose result you want to open. The selected test result dialog box will appear. When you touch
, a list of results for the selected patient is displayed (see page 153). All Results Doe, John 02/15 10:52 Trop-T Smith, Adam 02/15 10:11 proBNP Zend, Nora 02/15 09:40 DDimer Smith, Bob 02/14 11:40 Trop-T Smithee, Aaron 02/14 10:50 proBNP 04/19/2015 Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Pat:
Op:
Par:
02/08/2015 09:49 620 pg/ml New Strip Lot 04/19/2015 154 Quality control (QC) results This memory area contains all test parameter-specific quality control tests (QC, starting on page 139) that were run, sorted chronologically. The most recent results are at the top of the list. Review Results QC Results L2 08:30 L1 08:00 L1 10:17 L2 07:30 High 07:05 DDimer 02/12/15 DDimer 02/12/15 proBNP 02/04/15 DDimer 01/10/15 DDimer 01/10/15 04/19/2015 QC Result Code:
Level:
proBNP PBC014 JONES, TOM Par:
QC:
Op:
PB1234 1 04/18/2015 10:17 1 Touch or to display the entry of choice on the screen. 2 Touch the entry you want to open. The entry is displayed. Pass:
329 pg/ml
(350 / 300-400 pg/ml) 04/19/2015 155 Review Results Instrument quality control (IQC) results This memory area contains all instrument quality control tests (IQC, starting on page 147) that were run, sorted chronologically. The most recent results are at the top of the list. 1 Touch or to display the entry of choice on the screen. 2 Touch the entry you want to open. The entry is displayed. IQC Results Pass 07:59 Pass 08:16 Fail 08:01 Pass 08:30 Pass 09:02 IQC 04/11/15 IQC 04/07/15 IQC 04/07/15 IQC 03/29/15 IQC 03/29/15 04/19/2015 QC Test - Result Par:
IQC Op:
JONES, TOM Code:
Level: 1 IQC702 02/08/2015 10:17 83 %
(85 / 82 - 88 %) 04/19/2015 156 Maintenance history Maintenance History actually is a list of comments. Whenever routine maintenance or service is done for the meter, this event can be stored in form of a comment. You may use the default preset comments in the meter or enter a custom comment. Review Results Maintenance History Meter Cleaned 04/13/2015 08:00 Meter Cleaned 04/05/2015 08:20 Meter Cleaned 03/29/2015 09:00 New Battery Pack 03/21/2015 08:30 Meter Cleaned 03/14/2015 08:10 New 04/19/2015 1 Touch or to display the entry of choice on the screen. Once saved, a maintenance comment can not be opened or edited. Maintenance History is
(like test results) a view-only list. You can, however, add new entries:
2 Touch New. 3 Touch or to display the predefined comment of choice on the screen. 4 Touch the predefined comment you would like to add to the Maintenance His-
tory or:
5 Touch Custom to enter your own text using the onscreen keypad. 6 Touch to save your comment. 157 Review Results This page intentionally left blank. 158 Extended Functionalities 7 Extended Functionalities Data handling Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. When used in conjunction either with WLAN (if the meter is equipped with WLAN) or with the
(optional) Handheld Base Unit from Roche Diagnostics, the cobas h 232 meter can conveniently connect to a data management system (DMS). The main advantages of such a connection between meter and DMS may include:
Transferring patient lists, operator lists, and settings from the DMS to the meter. In this way the setup for daily work as well as general meter setup can be performed (for one or more meters) quickly and conveniently. Transferring all stored test results with the corresponding Patient ID, Operator ID, and comments from the meter to the DMS. This transfer of data permits further evaluation or proper archiving according to your needs. Through the DMS the system administrator (such as the POC coordinator) may specify what set-
tings are to be applied to a set of meters within a site or unit (e.g., hospitals or wards). All meters assigned to a specific site and/or unit would consequently share the same settings. The different operator and patient lists (that match a site or unit) are then made available on their respective meters. Other settings such as QC Lockout and Operator Lockout may easily be set (once) and distributed to all meters. The option of setting up an Operator Lockout is available only when operator lists are created on the DMS, stored in the meter, and Operator login is activated. For more details on Operator login see page 89, for details on Operator Lockout see page 95. 159 Extended Functionalities Computer (Setup option) For initial connection to a DMS, the ability to communicate within a network has to be set up as follows:
In the Setup menu, the Connection option must be set to Computer (see page 68). The Handheld Base Unit must be configured correctly. (For details please refer to the manual of the Handheld Base Unit and the Technical Note stored on the Handheld Base Unit itself.) Place the meter on a Handheld Base Unit that is connected to the network. The meter will automatically be recognized by the DMS and may now be assigned to a site and/or unit managed by the DMS (if your DMS has that functionality). Depending on DMS functionality available, the DMS may transfer settings and lists to the meter as well as enable test results to be transferred from the meter to the DMS. 160 Extended Functionalities Operator lists After powering the meter on, an Operator login may be configured. If no list is available, the options described on page 89 apply. Operator is set to Optional or Required:
The Operator can either log in via the onscreen keypad or a barcode scan. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are entered via the onscreen keypad or read from the barcode and stored with test results for informational purposes only. Operator is is set to Scan Only:
The display of the meter's onscreen keypad is blocked. The Operator can only log in via a barcode scan as there is no onscreen keypad. The use of the meter is not restricted to a predefined Operator group, so Operator IDs are read from the barcode and stored with test results for informational purposes only. Meters which are managed by a DMS may receive an Operator list. Operator ID is set to List, a list is available and displayed on the login screen:
The Operator selects the ID from the displayed list. If so configured by the Administrator, the Operator may also be required to enter a password to log in. Operator ID is set to Hidden List:
The Operator can login via a barcode scan or the onscreen keypad. If so configured by the Administrator, the Operator may also be required to enter a password to log in. When working with operator lists: The use of the meter is restricted to the operators on this list. 161 Extended Functionalities Patient lists When starting a Patient Test, there will be the option of either selecting a Patient ID from a patient list, entering the Patient ID using the onscreen keypad or, if available, of scanning the barcode with the Patient ID. The Patient ID, if entered on the DMS, comes with an additional identification entry. Up to 20 characters can be used and assigned as a second confirmation
(e.g., name, date of birth). There are four possible configurations for a Patient ID input:
The Patient ID is set to Optional or Required, and there is no list available:
A Patient ID can be entered manually via the onscreen keypad or read in via a barcode scan. The Patient ID is stored with the test result. The Patient ID is set to No, but there is a list available:
The list of Patient IDs is always shown when starting a test. You may now select a patient from the list;
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. Instead of an ID a consecutive number will be assigned to this result. The Patient ID is set to Optional or Required, and there is a list available:
The list of Patient IDs is always shown when starting a measurement. You may now select a patient from the list;
scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. You may either read the ID using the bar-
code scanner or enter a new ID via the onscreen keypad. The Patient ID is set to Hidden List (only possible with a data management system), and there is a list available:
An empty list is shown when starting a measurement. You may now scan a Patient ID using the barcode scanner;
create a new patient entry by touching New. You may either read the ID using the bar-
code scanner or enter a new ID via the onscreen keypad. When working with Patient lists, you have the following options:
A Patient ID does not have to be on the list to be scanned and used. The meter displays a warning that the Patient ID scanned is not on the list. The meter displays an error message that the ID was not found on the list of valid Patient IDs. You must enter a valid ID to proceed. 162 Extended Functionalities Barcode scanner Using a DMS, the barcode scanner may be configured to accept only selected barcode symbol-
ogies. Furthermore, it is possible to define a barcode mask for Patient ID and Operator ID. With masks being defined, the meter checks a barcode after scanning and rejects it, if it does not match the mask. See Example of barcode symbologies on page 183 for further information. Stored test results and comments When performing a test, the test result will be stored along with additional information, including the Patient ID, Operator ID, the kind of test performed, and optional Comments. The meter comes with a default set of Comments that can be assigned to each test result. If you are working with a DMS, these comments can be replaced by the comments in the DMS. The new wording will then be available for selection from the Comments list in the meter. Up to 3 comments can be assigned to each result. The Comment function may be configured to be either optional, required for test results which are out of range, or always required. If the user is required to enter/select a comment, com-
pletely empty comments will not be accepted by the meter. 163 Maintenance comments Meter Cleaned Samp. App. Area Cl. (Sample Application Area Cleaned) Test Strip Guide Cl. (Test Strip Guide Cleaned) New Battery Pack Extended Functionalities The default preset comments in the meter are:
Patient and QC Result comments Symptomatic Asymptomatic Chest Pain Dyspnea Intermediate Zone Doctor Notified RN Notified Under Medication Will Repeat Test No Action New Strip Lot New Strip/Kit Lot New Lot Number Lab Draw Cleaned Meter Switched QC Vial Repeat Control Test Acceptable Control New Control Lot Procedure Error 164 Maintenance and Care 8 Maintenance and Care 8.1 Conditions for storage and shipping Storage Store the system and test strips in the same environment in which they are used. Do not store the meter in direct sunlight or under extreme temperature conditions. Observe the limits for temperature and humidity when storing and using the meter (see Chapter 10). 165 Maintenance and Care Shipping Observe the following safety information when shipping the meter and battery pack. Failure to do so may result in injury to persons or damage to the meter or battery pack. If the meter is shipped or transported over long distances, always remove the battery pack from the meter. This eliminates the possibility of the battery pack overheating due to a short-circuit in the meter. It also prevents deep discharge and other damage to the bat-
tery pack or meter. Only ship undamaged battery packs. Damaged battery packs must be disposed of locally. See page 18 for the risks associated with damaged battery packs and disposal informa-
tion. Package the battery pack for shipping so that it cannot move around in the packaging. Also observe any other applicable national regulations. When shipping via third parties (e.g., by air or parcel service), work with the carrier to check whether specific requirements need to be met in relation to the lithium-ion battery packs on the basis of national or international laws on hazardous goods and, where appli-
cable, if special packaging and labeling requirements apply. For short distances - example between a facilitys sites - users may transport the battery packs
(either installed in the meter or separately) by road without having to meet further require-
ments. 166 Maintenance and Care 8.2 Cleaning and disinfecting the meter Difference between cleaning and disinfecting Cleaning is the physical removal of organic soiling (e.g., dirt, or other foreign material) from the meter surface. Disinfecting is the removal of most, but not all, disease-causing and other types of micro-
organisms (blood-borne pathogens) from the meter. When should the meter be cleaned and disinfected?
Clean the meter to remove visible soil and organic material for safe handling and/or prior to disinfecting. You can use the Cleaning Lockout function (see page 106) to ensure regular checks are performed. What to clean and disinfect?
The following parts of the meter may be cleaned/disinfected:
The visible area of the test strip guide The test strip guide cover The meter display (touchscreen) The meter housing (entire meter surface - front and back) Observe the disinfection guidelines of your institution. Use gloves. NOTICE Follow the procedures below to clean/disinfect the meter. Failure to follow these procedures may cause malfunction of the meter. 167 Maintenance and Care NOTICE Instrument damage due to moisture Ensure that no liquid enters the meter. If moisture enters the meter, it may cause malfunction of the instrument. Make sure the meter is powered off. Unplug the power adapter. Do not spray anything onto the meter housing. Do not spray into the test strip guide. Do not immerse the meter in liquid. Use only ordinary lint-free tissues. Do not use cloths that are saturated. Squeeze off excess solution or blot on a dry paper towel to remove any excess solution before wiping the surface of the meter. 168 Maintenance and Care Recommended cleaning/disinfecting agents Before using a cleaning/disinfecting solution on the meter refer to the product labeling for required contact time for cleaning/disinfecting and to ensure that the active ingredients are acceptable for use. Prepare all solutions per the manufacturers product labeling. Acceptable active ingredients are listed below. Recommended cleaning agents mild soapy water 70 % (or less) solution of isopropyl alcohol in water 0.625 % (or less) solution of sodium hypochlorite in water (bleach) Recommended disinfecting agents 0.625 % (or less) solution of sodium hypochlorite in water (bleach) quaternary ammonium compounds up to 0.5 % (single compound or mixture) in isopropyl alcohol (isopropanol) up to 55 %*
NOTICE Do not use any other disinfectants/cleaning agents on the meter
(housing or the test strip guide cover). Use of other disinfectants/
cleaning agents could result in damage to the meter. Cleaning/disinfecting the exterior (meter housing) Use only the solutions recommended above. Basic sequence of steps for cleaning First remove any blood and other dirt using water or soapy water. Then disinfect the meter's housing. 169 Maintenance and Care Cleaning after contamination due to mispipetting Observe the following precautions to prevent instrument damage Do not move the meter to prevent liquids from creeping and penetrating the meter. Dab away all visible blood (also on the test strip, but not in the application area). Do not use the meter before the liquid/moisture has been completely removed. While it is drying, the meter must not be moved as this may soil the optical components. For detailed cleaning instructions (how to clean) for the individual components of the meter, see the following pages. The instructions below describe only the sequence of steps to be taken in case of mispipetting. With the meter powered off, remove the test strip guide cover. Remove and dispose of the test strip. Clean the soiled parts of the meter with a moistened cotton swab/bud or tissue. Disinfect the meter. 170 Cleaning the test strip guide cover Maintenance and Care 1 If required, remove the meter from the Handheld Base Unit and place it horizon-
tally on a table. 2 Remove the test strip guide cover by pull-
ing it forward horizontally (in the direction of the arrow). Move the cover safely away from the meter and wipe it clean using the solu-
tions recommended above. In case of significant soiling or contami-
nation, you can rinse the test strip guide cover with warm water, dry it with a fresh tissue, and then disinfect it using the solu-
tions recommended on page 169. Always ensure that the test strip guide cover is completely dry before re-attach-
ing it to the meter. 3 Clean the outside of the meter with a lightly moistened tissue. Then dry the meter with a fresh tissue. 171 Maintenance and Care Cleaning the visible area of the test strip guide 1 Clean the easily accessible and visible pipetting field area of the test strip guide with moistened lint-free tissues. Then dry the test strip guide with a fresh tissue. Adhere to the following:
Clean only the visible area of the test strip guide. Do not insert any objects into the con-
cealed areas of the test strip guide as this will damage the optical components of the meter. Do not use objects to try to scratch off any dried contaminants in the test strip guide. 2 Clean the membrane (small circle) in the visible area at the end of the test strip guide with a moistened tissue. 3 Allow the inside of the test strip guide to dry for about 10 minutes. 4 After this time, re-attach the test strip guide cover to the housing. Make sure that the cover is properly attached. You will feel it snap into place. 172 9 Troubleshooting Troubleshooting The cobas h 232 meter continually checks its systems for unexpected and unwanted conditions. These may arise for technical reasons (defective components or consumables, environmental factors) or due to handling and procedure errors. Depending on the circumstances, a message may appear on the display of the meter. These messages are marked with an icon, either for an error message. All messages displayed by the system are accompanied by a description of the error and a pos-
sible solution. for a status message, or Take the action suggested on screen to resolve the problem. If the error disappears, you may continue using the meter as desired. If the problem persists, contact Roche (see page 197). The two different message types are illustrated below:
Display/symptom Description I-001: Battery Low Battery Low I-001 The battery is getting low. Replace or recharge battery pack as soon as possible. E-101: Patient ID Required Patient ID Required E-101 A patient ID is required. Enter a valid patient ID. Status message Touch to proceed with the next step. Error message Touch solve the problem. to exit this message. Perform the suggested step(s) to 173 Troubleshooting Errors and unusual behavior without error messages Some conditions may arise that have no associated error or status message. Display/symptom Description No message or unusual behavior Meter display does not power on Wait 10 seconds and try powering on the unit again. Check that the meter has power. If you are using the external power adapter, is it connected properly to the meter?
Or:
Place the meter in the Handheld Base Unit. Or:
If you are using the Handheld Battery Pack, is it properly installed in the meter?
Refer to the package insert for the test strips. The meter powers off after a configurable time without activity (e.g., pressing a key, touching the screen) to conserve energy. Reactivate the meter/screen as described in the following:
Press the On/Off button of the meter. Meter displays an unexpected result Automatic shutdown Shutdown after time spec-
ified by system administra-
tor (default is 5 minutes, configurable by system administrator) 174 Troubleshooting Display/symptom Description Communication Problems with the Data Management System via RF The cobas h 232 meter is unable to communicate with the Data Manage-
ment System. Check WLAN functionality on the meter (see the Wireless Setup screens in section Diagnostics starting on page 80). Dock the RF enabled meter into a hard-wired base unit to transfer the data. Reset the meter (see page 176). If the error persists, contact your Roche representative. 175 Troubleshooting Meter reset A meter reset should only be performed if all other remedies have failed. 1 Place the meter on a level surface. 2 Press the button for at least 12 seconds. The meter powers off and on again. The Roche logo is displayed. If the Roche logo does not appear within 60 seconds, place the meter in the Hand-
held Base Unit for a minimum of 15 minutes to recharge the battery. The meter performs a system check. The screens for entering the date and the Self-Check 09:15 am Self-Check 09:15 am Performing self-checks... SW Version: 04.00.00 Self-checks complete. 04/19/2015 SW Version: 04.00.00 time appear. 04/19/2015 3 Enter the date and time. After you have entered the correct information, confirm each screen with
. Unless all lockouts are disabled (see chapter 3.4), the meter will now be in QC Lockout due to the manually entered date/time. 4 Synchronize the meters date/time with the date/time of your facility via the Hand-
held Base Unit or, if working wirelessly, wait at least ten minutes for the next WLAN synchronization before performing any further tests. Even if your configuration does not require it, we recommend always performing a QC test after a meter reset. Year:
Month:
Day:
Set Date 2015 1 Hour:
Set Time 3 1 Minutes: 49 04/19/2015 AM PM 04/19/2015 176 General Product Specifications 10 General Product Specifications 10.1 Operating conditions and technical data Technical data Temperature range Relative humidity Maximum altitude Position Measuring range Memory Interface Supported barcodes Battery operation Mains connection Number of tests with fully charged battery Safety class Automatic power-off Dimensions Weight 18-32 C 10-85% (no condensation) 4300 m Always place the meter on a level, vibration-free surface when applying the sample to the sample application area of the test strip. Once the sample has been completely absorbed by the test strip, you can move the meter. Depends on test parameters 2000 Patient Test Results 500 QC Test Results 200 IQC Test Results 100 Strip Code Chips 100 QC Code Chips 4000 Patient List entries 5000 Operator List entries Infrared interface, LED/IRED Class 1 Code 128, Code 39, Code 93, EAN 13, Interleaved 2 of 5, Codabar, QR Code, DataMatrix, PDF417, Aztec Handheld battery pack Power adapter:
Input: 100-240 V AC ( 10%) / 50-60Hz / 350-150 mA Output: 12 V DC / 1.25A approx. 10 tests III Programmable 1 60 minutes 275 102 55 mm approx. 650 g incl. battery pack and scanner 177 General Product Specifications Sample material Sample type Sample size Interactions Heparinized venous whole blood 150 L Refer to test strip package insert Storage and transport conditions Temperature range Relative humidity 25 C to +70 C 10 to 85% (no condensation) 10.2 Further information Ordering information Please contact your specialist supplier. Item Roche CARDIAC POC Troponin T Roche CARDIAC POC Control Troponin T Description 10 tests for quantitative detection of cardiac Troponin T Control set for use with Roche CARDIAC POC
(control set for 2 x 6 quality control checks, level 1/2, and code chip) 10 tests for quantitative detection of cardiac Troponin T Quantitative (control set for 2 x 6 quality control checks, level 1/2, and code chip) Control set for use with Roche CARDIAC T Quantitative (control set for 2 x 6 quality control checks, level 2, and code chip) 20 tests for quantitative detection of myoglobin Roche CARDIAC T Quantitative
(Troponin T) Roche CARDIAC Control Troponin T Control set for use with Roche CARDIAC T Roche CARDIAC Control Troponin T
(Germany only) Roche CARDIAC M Roche CARDIAC Control Myoglobin Control set for use with Roche CARDIAC M
(control set for 2 x 6 quality control checks, level 1/2, and code chip) 10 tests for quantitative detection of D-Dimer Control set for use with Roche CARDIAC D-Dimer (control set for 2 x 6 quality control checks, level 1/2, and code chip) Roche CARDIAC D-Dimer Roche CARDIAC Control D-Dimer REF 07007302190 07089643190 04877772190 04890515190 05453879190 04877799190 04890469190 04877802190 04890523190 178 General Product Specifications Item Roche CARDIAC proBNP+
Roche CARDIAC Control proBNP Roche CARDIAC CK-MB Roche CARDIAC Control CK-MB Roche CARDIAC IQC Roche CARDIAC pipettes Description 10 tests for quantitative detection of NT-proBNP
(measuring range 60 - 9,000 pg/mL for meter software version 01.04.01) Control set for use with Roche CARDIAC proBNP+
(control set for 2 x 6 quality control checks, level 1/2, and code chip) 10 tests for quantitative detection of CK-MB Control set for use with Roche CARDIAC CK-MB
(control set for 2 x 6 quality control checks, level 1/2, and code chip) Set of two re-usable control strips (high/low) including code chip. Needed for checking the performance of the meters optical system 20 disposable syringe pipettes (150 L) for blood application Universal battery pack Rechargeable battery pack for cobas h 232 meter Test strip guide cover Battery compartment cover Power adapter Handheld Base Unit cobas h 232 meter cobas h 232 meter with scanner cobas h 232 Operators Manual cobas h 232 Operators Manual cobas h 232 Manual CD Printer cobas h 232 (CMP-10) ROW Printer cobas h 232 (CMP-10) EMEA Printer cobas h 232 (CMP-10) JAP Normal thermal paper roll Thermal paper roll (self-adhesive) Standard version without scanner Patient/Operator ID can be scanned from a barcode Printed manual (English) Printed manual (German) Contains Operators Manuals and Quick Refer-
ence Guides in all available languages (PDF) for most North American, Latin American and Asian countries for most European, Middle East and African countries for Japan 5 rolls per package, 50 mm diameter 10 rolls per package, 50 mm diameter Note: Not all items are available in all countries. REF 05533643190 04890493190 04877900190 04890426190 04880668190 11622889190 04805640001 04990315001 04990307001 07006098001 04805658001 04901126190 04901142190 07469101001 07532920001 07469314001 05404495001 05404517001 05404509001 03666751001 05412951001 179 Warranty Product limitations Please read the information in the package insert supplied with the test strips for detailed product data and limitations. Information about software licenses This product incorporates software modules developed under open source licenses. The source code of this software can be requested on a standard data exchange medium from the manufac-
turer at the following address:
Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim, Germany The General Public License (GPL) licensing conditions are available (in English only for legal rea-
sons) as a text file (file name License_txt.PDF) on the CD supplied with this manual. The com-
plete license agreements are also stored as a text file (file name license.txt) on the Handheld Base Unit. You can access this file by connecting the base unit to a PC with the USB cable. For detailed instructions on how to do this, see the Operator's Manual of the Handheld Base Unit. Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed. Repairs Please note that repairs and other modifications to the meter may only be performed by persons authorized by Roche. 11 Warranty The statutory guarantee provisions on rights in consumer goods sales in the country of purchase shall apply. 180 A Appendix A.1 Working with barcodes Risk of barcode read errors WARNING If a barcode is read incorrectly, this may lead to patient misidentification and therefore to inappropriate therapy decisions. When creating patient or operator barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. In particular, ensure that barcode size and print quality (as defined in ISO/IEC 15416 and 15415) are adequate. Inadequate print size and/or quality may lead to erroneous decoding. In addition every user must carry out a plausibility check on all data scanned into and displayed by the instrument. To reduce the probability of the barcode being misread, it is strongly recommended that you use the configuration options for patient and/or operator ID validation as applicable to your specific workflow. These options are:
check ID against list or check ID for length1 check if the scanned bar code type is allowed and activated in the DMS use barcodes with check digits In combination with the above options or as a single measure, use an appropriate barcode mask if this is compatible with the structure of your barcode content. Always make sure that the entire barcode is covered by the green light frame when scanning. 1. If no operator/patient list can be used, it is recommended that you at least set a minimum length for the respective ID, even if your facility uses IDs of varying length. 181 A.2 Operator and patient ID barcode masks Barcode mask character Definition A-Z, 0-9 Dollar ($) Asterisk (*) Tilde (~) Plus (+) Caret (^) If not preceded by the Caret (^), the scan data character must be the same as the mask character. This character is not saved as part of the ID. If the characters are not the same, the scan data is not a valid ID. The scan data character in this position is kept as part of the ID. The scan data character in this position is not kept as part of the ID. The scan data character in this position must be a number, 0-9, and it is not kept as part of the ID. If the scan data character is not a number, the scan data is not a valid ID. The scan data character in this position must be an alpha character, A Z, and it is not kept as part of the ID. If the scan data character is not an alpha character, the scan data is not a valid ID. This mask character denotes that the scan data character must be equal to the next character in the barcode mask after the ^, and that the scan data character is kept as part of the ID. If the scan data character is not equal to the mask character following the ^, the barcode reading is invalid as an ID. The allowed maximum length of a barcode mask is 60 characters for 1D barcodes 300 characters for 2D barcodes 182 A.3 Example of barcode symbologies EAN 13 barcodes, although widely used in retail, are less recommendable for patient/
operator barcodes. If used nonetheless:
they demand the very highest quality standards of barcode creation and reproduction the start sequences 978 (ISBN) and 979 (ISMN) may not be used and will be ignored as a part of any ID code The use of Interleaved 2/5 barcodes is not recommended. The barcode samples shown here are for illustration purposes only. If printed out, they can be used to check the barcode scanner. However, they are not meant to be used as a reference for size or resolution of real patient or operator ID barcodes. When creating patient or operator bar-
codes always refer to the relevant standard ISO/IEC 15416 and 15415 for size and resolution requirements and to the specification listed below. Recommended Specification Remarks Print resolution 300 dpi preferred 200 dpi minimum Reflective contrast 70% or greater Symbol grade Grade C or above Grade B is preferred Symbol grades are A-F based on analysis of several quality elements. Module width
(minimum) 0.16 mm (linear barcodes) 0.20 mm (2D barcodes) At 200 dpi issues with the wide-to-
narrow ratio may exist. Matte finish is preferred over gloss finish. Depending on quality grade parameters for a specific bar code, grade C may not be sufficient when motion, reflection, or poor lighting occur. 183 Codabar Code 39 Code 93 EAN 13 PDF417 Code 128 Interleaved 2/5 without checksum Aztec Roche Professional Diagnostics Roche Professional Diagnostics DataMatrix QR Code Roche Professional Diagnostics Roche Professional Diagnostics 184 A.4 Supported characters in 2D barcodes The 2D barcode scanner is able to read characters from the following unicode ranges:
Basic Latin (0021-007E) Latin-1 Supplement (00A1-00FF) Latin Extended-A (0100-017F) The 2D barcode scanner does not support Asian characters. 185 This page intentionally left blank. 186 B Appendix B.1 Option: Wireless network (WLAN) Preliminary note Appendix B has been developed to explain the wireless communication principles of the cobas h 232 system1 and to help your facilitys information technology/management team(s) in effectively deploying the cobas h 232 system on your wireless network. Whether your meter has wireless capability or not depends on the system configuration that you purchased. Background The cobas h 232 meter can only be configured through a data management system to communi-
cate wirelessly. The data management system is also used to set-up and configure the meter to connect to one hospital specific Wireless Local Area Network (WLAN2). WLANs use electro-
magnetic waves in the 2.4 and/or 5.0 GHz frequency range to wirelessly transmit data3. The cobas h 232 system adheres to IEEE Standard 802.11g (2.4 GHz range)4. The system is back-
wards compatible to 802.11b. During wireless communication to an Access Point (AP), the cobas h 232 meter recognizes the existent AP WLAN protocol configuration (802.11b or 802.11g) and automatically transmits data using the appropriate communication protocol5. 1. 2. 3. 4. 5. The cobas h 232 system is certified by the Wi-Fi Alliance. WLAN is also commonly referred to as wireless LAN or Wi-Fi. For the wireless functionality to work properly, the wireless module must first be configured by your system administrator. While the cobas h 232 system adheres to the 802.11g standard, it uses only channels 1-11. Channels 12-14 are not used by the system. WLANs are organized in cells. A typical WLAN cell consists of Access Point(s) that are connected to the (wired) Local Area Network and one or more clients, e.g., cobas h 232 meters along with other clients such as portable computers. 187 The loss of signal or access to bandwidth of one particular client may vary depending on one or more of the following situations: the type and number of other clients, the performance of the Access Point, the presence of electromagnetic disturbances, and other potential interfering fac-
tors, e.g., concrete walls. The cobas h 232 meter uses a burst-like communication protocol that will only consume band-
width if there is actually data to be transferred. Compared to other applications, such as Voice over Internet Protocol (VoIP) or multi-media applications, the meters bandwidth consumption is minimal. If the WLAN that the cobas h 232 meter seeks to connect to is degraded, the meter design minimizes the impact on functionality. Technical implementation Prior to connecting any wireless device to a wireless network, it is recommended that a WLAN site survey be performed. The goal of a WLAN site survey is to ensure that Access Points will pro-
vide enough coverage and performance to support any new radio frequency (RF) application or device. The survey will also detail RF signals, including all existing WLANs along with any com-
peting RF signals and interferences (building structure related and other wireless equipment /
devices). As part of an RF implementation of the cobas h 232 system, it is recommended that at minimum one base unit be hard wired per floor. A networked base unit provides redundancy if a wireless network malfunctions or loses service. If the cobas h 232 meter with RF is used in an area with low signal or interferences, it is recommended to install a connected base unit for redundancy. The redundancy of the connected base unit allows immediate transmission of patient results when the meter is docked. 188 The current RF system consists of an antenna and a WLAN system-on-chip (SoC) along with other components. The WLAN system-on-chip is the core of the WLAN system. The RF system used in the cobas h 232 meter specifically adheres to the following specifications:
Its WLAN system-on-chip supports IEEE 802.11b and 802.11g. It works seamlessly together with other Wi-Fi certified transceivers. It also implements the Wi-Fi Protected Access (WPA - Enterprise and WPA - Personal), Wi-Fi Protected Access 2
(WPA2 - Enterprise and WPA2 - Personal), and Wired Equivalent Privacy (WEP) secu-
rity mechanisms with Temporal Key Integrity Protocol (TKIP) and Advanced Encryption Standard (AES). In addition, the system supports the extensible authentication protocol (EAP) with EAP-TLS, EAP-TTLS/MSCHAPv2 and PEAPv0/EAP-MSCHAPv2. The cobas h 232 meter interoperability Wi-Fi certificate can be accessed at http://certifications.wi-fi.org/search_products.php. Further information including a glossary of terms, frequently asked questions, and other topics related to Wi-Fi technology can be found on the Wi-Fi Alliance site
(http://www.wi-fi.org/). The used channels in the 2.4 GHz-band are channels 1-11. (Channels 12-14 are not used by the cobas h 232 meter.) RF output power is approximately 15 dBm at a data rate of 54 MBPS. 189 RF specific functionalities and effective performance claims The cobas h 232 system offers the option of wireless network connectivity (WLAN/Wi-Fi). If you purchase a system with this option, the WLAN function is enabled during production. This module can only be configured by a data management system (DMS), which activates the meters wireless communication and data transfer capabilities. Wireless connectivity can help to ensure that updates to information in the DMS are sent immediately to all networked meters. Meters with an integrated and activated wireless option use the base unit for recharging and/or as a redundant communication option to exchange data with the DMS. The meter also has to be docked if the hospital changes security protocols. When this change occurs, it may lock out all meters until docked and reconfigured with the new protocol. As described above, the cobas h 232 meter supports the 802.11g standard. This translates into the following RF specific performance claims:
The cobas h 232 meter is capable of transferring to a suitable DMS, via WLAN, a data set of up to 1000 result records, 100 reagent records, and 500 operator ID records in less than 15 minutes, when operated in a typical WLAN environment (correct WLAN administra-
tion, typical population of other clients present, any of the supported security models ena-
bled). A cobas h 232 meter with wireless connectivity enabled will communicate results after every test or when the meter is idle; it will automatically attempt to communicate with the DMS every 10 minutes. In line with the industry communication standard POCT1-A, the DMS must acknowledge the meters request for connection and actively query for the result. Only upon receipt of this DMS query, the meter will send the result. Hence the effective time for transmitting results depends on infrastructure, DMS workload, etc. Once the DMS sends a query, however, the meter will respond within a few seconds. 190 A typical range for direct connection between the cobas h 232 meter and the access point (air, direct view, low disturbances) is up to 15 to 20 meters (49 to 66 feet). The actual range depends on the positioning of the access points antennas and other topological properties of the space between WLAN device and AP. Additionally, dynamic control of the transmitting power of the access point may reduce the maximum distance between WLAN device and AP within which communication can be guaranteed. The cobas h 232 system is designed such that it coexists with other wirelessly communicating devices. The cobas h 232 system does NOT include any real-time or even time critical wireless functionality. It communicates exclusively single, digital data fields. It does NOT communicate continuous waveform data. Note: A degraded Quality of Service (QoS) of the WLAN communication will not impact the functionality of the meter but may delay the communication of results to the DMS. Users should be aware that real-time communication of test result readings cannot be guaran-
teed by the cobas h 232 meter. 191 This page intentionally left blank. 192 C Supplement for Observed Test Sequence Observed Test Sequence (OTS) The Observed Test Sequence (OTS) function allows an observer (supervisor) to assess and record an operators performance (e.g., for recertification purposes). The observer monitors an operator during a test to check that the test is being performed according to the recommended proce-
dures. He/she then evaluates the performance and passes or fails the operator. This assessment is saved together with the test result and any desired comments. Observed Test Sequence options can only be configured using a DMS. The availability of electronic configuration options will thus vary according to the data management software utilized by your institution. Consult your system administrator. 193 Using the OTS function A request for an Observed Test Sequence comes from the DMS. The presence of the on the Patient Test button indicates a pending OTS request. icon Main Menu 09:15 am Patient Test Control Test Review Results Setup Pat. Test - OTS Logout 04/19/2015 OTS enabled Observer Login Patient Test Observer 09:15 am 04/19/2015 Alan Smithee Ann Casey 04/19/2015 ScanPat. Test - OTS OTS enabled Observer Login Patient Test 04/19/2015 Observer:
1 Touch Patient Test. In the Pat. Test -OTS menu, the Patient Test button is grayed out (disabled) until the observer has logged in. 2 Touch Observer Login. 3 Wait until the observer list is displayed. 4 Select your observer ID by touching the corresponding button, or scan your operator ID (which is also your observer ID in this case).. Only operators with OTS observer rights are listed in the Observer Login list. 5 Enter the (optional) password. 6 After you enter your password, touch to log in. The Pat. Test - OTS menu is dis-
played again. The Patient Test button is now active. 7 Hand the meter to the operator who can now perform the patient test under supervision. 194 Pat. Test - OTS Remove Strip OTS enabled Observer Login Patient Test Remove Strip 04/19/2015 04/19/2015 Observer Login I-010 Observer ALAN SMITHEE, please log in to proceed. Otherwise the OTS test will not be complete. Observer OTS passed:
09:15 am Pass Fail Measurement Result OK?
Reject Accept Comment:
04/19/2015 Operator:
1 Touch Patient Test. Perform the patient test as usual. Once the test is completed, the observer has to com-
plete the next steps. 2 Hand the meter back to the observer. Observer:
3 Touch 4 After you enter your password, touch to log in again. to proceed with the assessment. 5 Assess the operators performance by touching Pass or Fail. 6 Assess the test result by touching Accept or Reject. 7 Touch 8 Touch screen. to add a comment. to return to the Pat. Test - OTS The OTS information is saved together with the test result. 195 This page intentionally left blank. 196 D Contact Roche For all questions about the cobas h 232 system that are not answered in this manual, contact your Roche representative. If you do not already have contact details, visit our website on www.roche.com. Select "Roche in your country" at the top of the page and then select your coun-
try to find the appropriate local office contact information. The cobas h 232 system is manufactured for and distributed by:
Roche Diagnostics Australia Pty Limited ABN 29 003 001 205 31 Victoria Avenue Castle Hill, NSW, 2154 197 This page intentionally left blank. 198 Index A Administrator ..................................................... 83 Administrator ID Change ......................................................... 87 Disable ......................................................... 88 Set up .................................................... 8386 Application area ............................................... 29 Apply sample ...................................................129 Opening (meter) ....................................... 25 Auto off ................................................................ 62 B Barcode ................................................... 121, 126 Masks .........................................................182 Symbologies .............................................184 Barcode (test strip) .......................................... 29 Barcode reader ................................................. 29 Barcode scanner .............................................. 25 Basics (setup) ............................................. 4963 Battery pack ....................................................... 27 Installing or replacing ...................... 3640 C Cleaning .................................................. 167172 After mispipetting ..................................170 Housing - outside ..................................171 Test strip guide .......................................172 Cleaning lockout ............................................106 cobas h 232 Contents of the pack .............................. 13 Introduction ................................................ 11 Operating conditions ............................177 Overview of meter elements ......... 2426 Test principle ............................................. 13 cobas IT 1000 .................................................... 11 Code chip ......................................... 29, 116117 Opening ....................................................... 26 Comment (custom) .......................................134 Comment result ..............................................134 Computer ............................................6468, 160 Connection .................................................. 6470 Contact Roche ................................................ 197 Contents of the pack .......................................13 Contrast .........................................................4950 Control material .............................................. 138 Custom range ........................................103, 104 D Data handling .............................................6481 Data Management System
(DMS) ....................................73, 83, 91, 92, 159 Data transfer ................................................... 159 Date ................................................................5354 Diagnostics ..................................................8081 Display format .............................................5758 Disposal ...................................................... 17, 115 E Error messages ............................................... 173 H Handheld Base Unit .........................................36 Handheld battery pack ............................25, 35 I Icons: see Symbols ID setup .........................................................8293 Overview ......................................................82 Infections (safety instructions) ................. 115 Infrared interface .................................... 26, 159 IQC lockout ...................................................... 101 L Language ......................................................5152 Lockout ....................................................... 94108 Cleaning lockout .................................... 106 IQC lockout .............................................. 101 New lot lockout ...................................... 100 Operator lockout ................................9597 QC lockout ............................................... 100 199 N New lot lockout .............................................. 100 O Observed Test Sequence (OTS) ......193195 On/Off button .....................................................25 Operating conditions .................................... 177 Operating the meter .................................35??
Operator ID .............................. 8991, 120122 Operator list ............................................121, 161 Operator lockout ....................................... 9597 Optional screens ...................................109111 Ordering information .................................... 178 Overview of meter elements ................. 2426 P Patient ID .................................. 9293, 124126 Patient list ......................................124126, 162 Power adapter Connection .......................................... 26, 30 Power supply ......................................................27 Contacts (Handheld Base Unit) ..........26 Powering on the meter .............119, 139, 151 Printer ............................................................ 6970 Product specifications ................................. 177 Q QC lockout ....................................................... 100 QC result format ....................................102, 103 Quality control ........................................137149 Control material ...................................... 138 IQC (instrument-specific) ..........147149 Pass/Fail .................................................... 149 Preparation ............................................... 137 QC (test parameter-specific) ....139145 M Meter Reset ...........................................................176 Meter setup Administrator ID ................................8386 Auto off ........................................................ 62 Basics ....................................................4963 Cleaning lockout ....................................106 Computer .............................................6468 Contrast ................................................4950 Data handling .....................................6481 Date ........................................................5354 Diagnostics ..........................................8081 Display format ....................................5758 ID setup ................................................8293 IQC lockout ...............................................101 Language .............................................5152 Lockout ...............................................94108 New lot lockout .......................................100 Operator ID ..........................................8991 Operator lockout ...............................9597 Optional screens ........................... 109111 Overview ...............................................4448 Patient ID ..............................................9293 Printer ....................................................6970 QC lockout ................................................100 QC result format ........................... 102, 103 QR Code ...............................................6567 Reset test parameters ...........................105 Result confirmation ...............................111 Result display mode .........................7879 Result login ...............................................110 Result memory ...................................7174 Result unit ............................................7577 Sound ....................................................5961 Start info ....................................................110 STAT test ...................................................107 Time ........................................................5556 200 T Test ............................................................113136 Performing .......................................123136 Preparing .........................................115122 Sample material ..................................... 115 Test area ..............................................................29 Test principle ......................................................13 Test steps (overview) ................................... 118 Test strip Inserting ...........................................127, 140 Lot ..................................................................98 Test strip guide ..................................................26 Test strip guide cover .....................................25 Time ................................................................5556 Touchscreen ................................................25, 43 Troubleshooting ............................................. 173 W Wi-Fi ......................................................................22 WLAN ................................................................. 187 R Reset ...................................................................176 Reset test parameters ..................................105 Result confirmation ............................. 111, 133 Result deletion (automatic) .......................... 74 Result display mode ................................. 7879 Result login ............................................ 110, 132 Result memory ..................................7174, 151 Result unit .................................................... 7577 Review results ....................................... 151164 All results ..................................................154 Data transfer ............................................159 IQC (instrument quality control) .......156 Maintenance ............................................157 Patient history ..........................................153 QC (quality control) ...............................155 RF (radio frequency) ..............................22, 188 S Safety Protection against infection ................. 15 User qualification ..................................... 15 Sample material .................................... 115, 178 Scan (button) ......................................... 121, 126 Self-check (powering on the meter) ......119 Software license .............................................180 Sound ............................................................ 5961 Specifications ..................................................177 Start info ............................................................110 STAT Test ............................................................ 94 Perform ......................................................136 STAT test Configure ..................................................107 Storage ...............................................................165 Storage and transport conditions ............178 Symbols Code chip ........................................ 128, 141 Error messages .......................................173 Hourglass ...............................130, 143, 144 Meter ...............................................................5 Packaging ......................................................5 Pipette .............................................. 128, 142 Screen ................................................... 3133 Thermometer ................................. 128, 142 201 This page intentionally left blank. 202 ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.poc.roche.com N E X X
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CoaguChek Pro II Manuel dutilisation Historique des rvisions Version du manuel Version 1.0 Version 2.0 Date de rvision 2015-11 2015-11 Modifications Nouveau document Informations de scurit rvises concernant la gestion des codes-barres, modifications mineures CoaguChek Pro II Manuel dutilisation Version 2.0 0 7576544001 (02) 2015-11 FR 2015 Roche Diagnostics GmbH. Tous droits rservs Le contenu de ce document ainsi que tous les graphiques sont la proprit de Roche Diagnostics. Les informations contenues dans ce document peuvent tre modifies sans pravis. Roche Diagnostics ne peut tre tenue responsable des erreurs techniques, des erreurs au niveau du contenu ou des omissions dans ce document. Aucune partie de ce document ne peut tre reproduite ni transmise sous quelque forme que ce soit ni par quelque moyen que ce soit, de faon lectronique ou mcanique, pour quelque raison que ce soit, sans la permission crite de Roche Diagnostics. Veuillez envoyer toute question ou tout commentaire concernant ce manuel votre reprsentant Roche local. ACCU-CHEK, COAGUCHEK et SAFE-T-PRO sont des marques de Roche. Toutes les autres marques sont dtenues par leurs propritaires respectifs. Le logo Wi-Fi CERTIFIED est une marque de certification de la Wi-Fi Alliance. 4 Sur lemballage et sur la plaque didentification de linstrument, vous pouvez trouver les symboles suivants qui sont prsents ici avec leur signification :
Attention, voir notice dinstructions. Se conformer aux consignes de scurit figurant dans les instructions dutilisation du produit. Limites de temprature (Conservation ) Utiliser jusque Fabricant Code du lot Rfrence du catalogue Dispositif mdical de diagnostic in vitro LOT IVD Ce produit rpond aux exigences de la Directive Europenne 98/79/CE concernant les dispositifs mdicaux de diagnostic in vitro. Consulter les instructions dutilisation Ce systme est conforme aux exigences de scurit du Canada et des tats-Unis
(UL LISTED, conformment aux normes UL 61010A-1:02 et CAN/CSA-C22.2 No. 61010-1-04). Sur les lecteurs disposant de la fonctionnalit WLAN :
Ce dispositif satisfait la partie 15 du rglement de la FCC et la norme CNR-210 d'Industrie Canada Pour les autres certifications WLAN, voir l'tiquette appose sur le bas du logement des piles et l'addenda concernant l'enregistrement du WLAN. 5 Cette page est intentionnellement laisse blanche. 6 1 2 3 7 Introduction 11 1.1 Avant de commencer ............................................................................................................................. 11 Utilisation prvue ............................................................................................................................. 11 Informations importantes concernant lutilisation............................................................... 11 Si vous avez besoin daide............................................................................................................ 12 Remarque gnrale......................................................................................................................... 12 Ce que le systme peut faire pour vous.................................................................................. 12 Principe du test................................................................................................................................. 13 Contenu de l'emballage................................................................................................................. 14 1.2 Consignes de scurit importantes et autres renseignements .............................................. 15 Informations sur la scurit.......................................................................................................... 17 Mise au rebut du systme ............................................................................................................ 18 Entretien gnral.............................................................................................................................. 18 Bloc-piles ............................................................................................................................................ 18 Interfrences lectromagntiques............................................................................................. 20 cran tactile........................................................................................................................................ 21 Rseau local: protection contre l'accs non autoris ....................................................... 21 Connexion au rseau cbl.......................................................................................................... 22 Connectivit sans fil........................................................................................................................ 23 Informations relatives l'exposition aux rayonnements de radiofrquences ........... 23 Conditions dutilisation................................................................................................................... 27 Contrle qualit ................................................................................................................................ 27 1.3 Aperu des lments du lecteur ....................................................................................................... 28 1.4 Aperu des touches et des symboles............................................................................................... 30 1.5 Alimentation............................................................................................................................................... 33 Mise en marche du lecteur 35 2.1 Installation ou remplacement du bloc-piles .................................................................................. 36 Retrait du bloc-piles........................................................................................................................ 37 Installation du bloc-piles............................................................................................................... 38 2.2 Mise sous tension et hors tension du lecteur............................................................................... 41 Vrification de la version du logiciel......................................................................................... 41 Configuration du lecteur 43 Remarque concernant la prsentation des lments apparaissant l'cran du prsent manuel ............................................................................. 43 3.1 Rsum des rglages ............................................................................................................................ 45 3.2 Rglages cran ......................................................................................................................................... 49 Contraste............................................................................................................................................. 49 Unit des rsultats........................................................................................................................... 50 Confirmation rsultats.................................................................................................................... 51 Choix de la langue........................................................................................................................... 52 Rglage de la date........................................................................................................................... 53 Rglage de lheure........................................................................................................................... 55 Rglage des options d'affichage de la date et de lheure................................................. 56 8 3.3 Rglage des options................................................................................................................................ 58 Tri............................................................................................................................................................ 58 Avertisseur sonore........................................................................................................................... 60 Arrt Auto............................................................................................................................................ 62 Connexion ........................................................................................................................................... 63 Code QR............................................................................................................................................... 64 PC........................................................................................................................................................... 67 Imprimante.......................................................................................................................................... 68 Slection paramtres ...................................................................................................................... 69 3.4 Rglage ID .................................................................................................................................................. 70 Administrateur systme (admin.) ............................................................................................... 72 Identifiant de lutilisateur .............................................................................................................. 76 ID patient ............................................................................................................................................ 77 3.5 Configuration Rglages CQ.................................................................................................................. 79 Intervalle CQ....................................................................................................................................... 80 Blocage CQ (contrle qualit)..................................................................................................... 83 Blocage Util. ...................................................................................................................................... 86 Configuration test URG.................................................................................................................. 88 Numriser matriel CQ .................................................................................................................. 90 3.6 Diagnostics................................................................................................................................................. 91 4 Mesure d'un chantillon de sang 93 4.1 Remarques importantes......................................................................................................................... 93 Recommandations concernant le prlvement de sang capillaire ............................... 95 Recommandations concernant la dtermination sur sang veineux total.................... 96 4.2 Prparation ................................................................................................................................................. 97 Puce d'talonnage des bandelettes-test ................................................................................. 97 Insertion de la puce dtalonnage ............................................................................................. 98 Mise sous tension du lecteur....................................................................................................... 99 4.3 Excution d'une mesure .................................................................................................................... 102 Dpt de sang depuis la pulpe du doigt.............................................................................. 108 Dpt de sang l'aide d'une seringue.................................................................................. 109 Validation ou refus d'un rsultat de test............................................................................... 112 Ajout de commentaires............................................................................................................... 113 Affichage du rsultat de test sous forme de code QR.................................................... 114 Fin du test......................................................................................................................................... 114 Tests URG......................................................................................................................................... 115 5 Test de contrle et de comptence 117 5.1 Test de CQ ............................................................................................................................................... 117 5.2 Prparation pour effectuer un test de contrle qualit liquide............................................ 118 5.3 Excution du contrle qualit liquide............................................................................................ 120 5.4 Test comptence ................................................................................................................................... 127 5.5 Prparation pour effectuer un test de comptence................................................................. 128 5.6 Ralisation d'un test de comptence............................................................................................. 129 9 6 7 8 9 10 Examen des rsultats (mmoire) 133 6.1 Consultation des rsultats en mmoire........................................................................................ 134 Afficher la mmoire Rsultats patient................................................................................... 136 Afficher la mmoire des rsultats de CQ (contrle qualit) ......................................... 137 Fonctionnalits tendues 139 7.1 Manipulation des donnes................................................................................................................ 139 PC (option de rglage)................................................................................................................ 141 Listes d'utilisateurs ....................................................................................................................... 142 Listes des patients ........................................................................................................................ 143 Validation de la liste des patients ........................................................................................... 144 Configuration des identifiants utilisateur et patient......................................................... 145 Lecteur de code-barres .............................................................................................................. 145 Rsultats de mesures enregistrs et commentaires........................................................ 145 Maintenance et entretien 147 8.1 Conditions de stockage et d'expdition........................................................................................ 147 Stockage........................................................................................................................................... 147 Expdition......................................................................................................................................... 148 8.2 Nettoyage et dsinfection du lecteur ............................................................................................ 149 Diffrence entre nettoyage et dsinfection......................................................................... 149 Quand le lecteur doit-il tre nettoy et dsinfect ?....................................................... 149 Que nettoyer et dsinfecter ?................................................................................................... 149 8.3 Agents de nettoyage/dsinfection recommands.................................................................... 151 8.4 Nettoyage/dsinfection de la partie extrieure (botier du lecteur) .................................. 152 8.5 Nettoyage/dsinfection de la glissire dinsertion des bandelettes-test......................... 153 8.6 Nettoyage de la fentre du lecteur de codes-barres .............................................................. 154 Dpannage 155 Informations supplmentaires sur l'erreur E-406.............................................................. 156 Erreurs et anomalies sans message d'erreur...................................................................... 157 Rinitialisation du lecteur .......................................................................................................... 158 Spcifications gnrales du produit 159 10.1 Donnes techniques ........................................................................................................................... 159 chantillon ...................................................................................................................................... 159 Conditions d'entreposage .......................................................................................................... 160 Conditions de transport .............................................................................................................. 160 10.2 Informations supplmentaires.......................................................................................................... 161 Consommables / accessoires .................................................................................................. 161 Ractifs et solutions..................................................................................................................... 161 Limitations lies au produit....................................................................................................... 161 Informations sur les licences dutilisation du logiciel .................................................... 162 Rparations ..................................................................................................................................... 163 Coordonnes de Roche .............................................................................................................. 163 11 Garantie 164 10 A B C Annexe 165 A.1 Masques de codes-barres d'identifiants utilisateur et patient...............................................165 A.2 Exemple de symbologies de codes-barres....................................................................................166 A.3 Caractres pris en charge pour les codes-barres 2D ...............................................................169 Annexe 171 B.1 Supplment relatif aux Squences de tests observs...............................................................171 Squence de tests observs (OTS ou Observed Test Sequence) .............................. 171 Utilisation de la fonction OTS ................................................................................................... 172 Annexe 175 C.1 Option : rseau sans fil (WLAN)........................................................................................................175 Explications...................................................................................................................................... 176 Mise en uvre technique .......................................................................................................... 177 Fonctions RF spcifiques et spcifications de performances efficaces ................... 179 Index 183 1 Introduction 1.1 Avant de commencer Utilisation prvue Informations importantes concernant lutilisation Le systme CoaguChek Pro II (lecteur CoaguChek Pro II et gamme de bandelettes-test CoaguChek) est utilis pour la dtermination de PT et d'aPTT par les profession-
nels de la sant dans un environnement de point de service. Veuillez lire ce manuel dutilisation et les notices daccompagnement des consommables concerns avant dutiliser ce systme pour la premire fois. Vous devez configurer le lecteur CoaguChek Pro II en fonction de vos besoins avant la premire utilisation. Rf-
rez-vous au chapitre 3, Configuration du lecteur. Assurez-
vous de lire la section Consignes de scurit importantes et autres renseignements de ce chapitre avant dutiliser le systme. La date et l'heure doivent tre correctement rgles avant la premire utilisation (cest--dire aprs l'instal-
lation du bloc-piles), afin de garantir la fiabilit des mesures. Vrifiez (et rglez si ncessaire) la date et l'heure chaque fois que vous remplacez le bloc-piles. Le Blocage CQ est dsactiv par dfaut. Pour la con-
firmation de routine de la fiabilit du systme, il est recommand d'activer cette fonction. 11 1 n o i t c u d o r t n I 12 Si vous avez besoin daide Remarque gnrale Ce que le systme peut faire pour vous Dans le prsent manuel, vous trouverez des informations sur lutilisation du systme, les menus de lcran et la faon deffectuer un test. Si des messages d'erreur apparaissent l'cran, veuillez vous rfrer au chapitre 9, Dpannage. Pour toute question concernant le systme CoaguChek Pro II dont la rponse ne se trouve pas dans ce manuel, veuillez contacter votre reprsentant Roche Diagnostics local. Pour acclrer le dpannage, veuillez avoir en main votre lecteur CoaguChek Pro II, le numro de srie, ce manuel et tous les consommables lors de votre appel. Les donnes et informations contenues dans ce manuel sont actuelles la date de publication. Toute modification substantielle sera incluse dans la prochaine dition. En cas de conflit d'informations, la notice d'emballage fournie avec les bandelettes-test CoaguChek prvaut. Le systme CoaguChek Pro II permet de mesurer facile-
ment les valeurs de la coagulation du sang. Il vous suffit d'insrer la puce d'talonnage dans le lecteur, de mettre en marche le lecteur, d'introduire la bandelette-test et d'y dposer un petit chantillon de sang. Le sang se mlange avec les ractifs de la bandelette-test et le lecteur dter-
mine le moment de coagulation du sang. Selon le para-
mtre de test slectionn, le lecteur affiche les rsultats aprs environ une minute (PT) ou aprs quelques minutes (aPTT). Une fois la mesure termine, le lecteur enregistre automatiquement en mmoire les rsultats de test ainsi que la date/l'heure et l'ID patient (et l'ID utilisa-
teur si cette option est active). Le lecteur CoaguChek Pro II affiche les rsultats du test dans des units quivalentes celles des mesures de plasma de laboratoire. Les rsultats peuvent ainsi tre affichs de diffrentes manires :
Paramtre : aPTT en secondes Paramtre : PT Rapport international normalis (INR, International Normalized Ratio) combinaison d'INR/Sec (rsultats du temps de Quick exprims en secondes) combinaison d'INR/%Q (rsultats du temps de Quick exprims sous la forme d'un pourcentage) L'indice INR est une mesure normalise de la vitesse de coagulation du sang. Un INR faible peut indiquer un risque accru de caillots sanguins, tandis qu'un INR lev peut indiquer un risque accru d'hmorragie. Le lecteur vous guide tout au long du test, pas pas, grce des symboles et des instructions figurant l'cran. Chaque bote de bandelettes-test possde sa propre puce d'talonnage, insrer dans le lecteur. Cette puce d'talonnage contient des informations relatives aux bandelettes-test du lot, telles que la date de premption et les donnes d'talonnage. Des contrles liquides optionnels sont galement disponibles pour le systme. Il est possible de connecter le lecteur CoaguChek Pro II un systme de gestion des donnes (SGD) par le biais de la station d'accueil de Roche Diagnostics (disponible sparment) ou via une communication sans fil (WLAN). Le lecteur CoaguChek Pro II prend en charge l'change de donnes via le protocole POCT1A. Les systmes de gestion des donnes peuvent parfois tendre les fonc-
tions de scurit du lecteur, telles que le blocage d'utili-
sateur. Les systmes de gestion des donnes peuvent galement permettre un transfert de donnes partir d'un SIH et/ou vers un SIL. Veuillez vous reporter aux manuels de la station d'accueil et de votre SGD pour les dtails techniques. Les tests CoaguChek contiennent des ractifs schs. Ces tests sont constitus d'activateurs, d'un substrat pep-
tidique et de composants non ractifs. Lorsqu'un chan-
tillon est appliqu sur une bandelette-test, le ractif se dissout et les activateurs dmarrent le processus de coagulation, ce qui conduit la formation de la throm-
bine (enzyme). Simultanment, le lecteur commence une mesure du temps. La thrombine clive le substrat pepti-
dique, ce qui gnre un signal lectrochimique. Selon lintervalle coul lors de la premire mission de ce signal, le signal est converti, laide dun algorithme, en units de coagulation usuelles (selon le test, en INR, en temps de Quick en pourcentage ou en secondes) et le rsultat s'affiche. 13 1 n o i t c u d o r t n I Principe du test 14 Contenu de l'emballage L'emballage du CoaguChek Pro II contient les lments suivants :
Lecteur CoaguChek Pro II Bloc-piles universel Alimentation Manuel d'utilisation (version imprime, non illustre ici) CD-ROM du manuel (contenant des fichiers PDF du manuel d'utilisation dans d'autres langues ;
non illustr ici) Ds le dballage, vrifiez que tous ces lments sont pr-
sents et qu'aucun n'a t endommag lors du transport. 1.2 Consignes de scurit importantes et autres renseignements 15 Cette section dcrit la manire dont les messages relatifs la scurit et les informations lies une utilisation cor-
recte du systme sont prsentes dans le manuel d'utili-
sation de CoaguChek Pro II. Veuillez lire attentivement ces sections. Le symbole d'alerte de scurit utilis seul (sans aucune mention d'avertissement) est utilis pour attirer l'atten-
tion sur des risques de scurit d'ordre gnral ou pour rediriger l'utilisateur vers d'autres sections du manuel contenant des informations de scurit spcifiques. Ces symboles et mentions d'avertissement correspondent des dangers spcifiques :
AVERTISSEMENT Signale une situation de danger susceptible de provo-
quer de graves blessures ou d'entraner la mort si elle n'est pas vite. ATTENTION Signale une situation de danger susceptible de provo-
quer des blessures lgres ou mineures si elle n'est pas vite. MISE EN GARDE Signale une situation de danger susceptible de provo-
quer un endommagement du systme si elle n'est pas vite. Les informations importantes ne relevant pas de la scurit apparaissent sur un fond color (sans sym-
bole). Vous trouverez ici des informations complmen-
taires concernant l'utilisation correcte du lecteur ainsi que des recommandations utiles. 1 n o i t c u d o r t n I AVERTISSEMENT ATTENTION MISE EN GARDE 16 Sur les illustrations de ce manuel figurent deux types de mains diffrentes :
Main non gante Main gante Une flche en pointills entre les illustrations d'crans indique que certains crans n'ont pas t reproduits. Informations sur la scurit Qualification de lutilisateur Seuls les professionnels de sant forms peuvent utiliser le systme CoaguChek Pro II. Les utilisateurs doivent galement avoir reu des instructions compltes sur lutilisation, le contrle de la qualit et les soins appor-
ter au systme CoaguChek Pro II. AVERTISSEMENT AVERTISSEMENT Protection contre les infections Il existe un risque potentiel dinfection. Les profession-
nels de sant qui utilisent le systme CoaguChek Pro II doivent tre conscients que tout objet entrant en contact avec le sang humain peut constituer une source dinfec-
tion. Le personnel mdical doit galement tre conscient que toute contamination croise constitue une source potentielle d'infection pour les patients. Utilisez des gants. Utilisez pour chaque patient un autopiqueur dsactivation automatique et usage unique. Jetez les lancettes et les aiguilles utilises dans un conteneur pour objets coupants muni dun couvercle. liminez les bandelettes-test usages conformment la politique de contrle des infections de votre tablissement. Vous devez respecter la rglementation locale en vigueur sur la sant et la scurit. Pour viter tout choc lectrique, incendie et explosion Utilisez uniquement des accessoires Roche Diagnostics d'origine (cbles, blocs d'alimentation, blocs-piles et pices de rechange). Les cbles, blocs d'alimentation et blocs-piles issus de tiers peuvent provoquer l'explosion du bloc-piles ou l'endommagement du lecteur. N'utilisez pas de prises d'alimentation mal fixes ou de blocs d'alimentation, cbles, fiches ou blocs-piles endommags. Ne court-circuitez pas le bloc d'alimentation, les contacts de la station d'accueil ou le bloc-piles. Ne laissez pas tomber le lecteur CoaguChek Pro II, le bloc d'alimentation ou le bloc-piles et protgez-les des agitations et des vibrations. 17 1 n o i t c u d o r t n I 18 Mise au rebut du systme AVERTISSEMENT Entretien gnral MISE EN GARDE Infection par un instrument prsentant un risque de danger biologique Le systme CoaguChek Pro II ou ses composants doivent tre traits comme des dchets prsentant un danger de contamination. Il est ncessaire de procder une dcontamination (c'est--dire un ensemble de proc-
dures comprenant le nettoyage, la dsinfection et/ou la strilisation) avant toute rutilisation, tout recyclage ou toute mise au rebut. liminez le systme ou ses composants conformment la rglementation locale. Retirez toujours le bloc-piles avant de procder une dsinfection thermique. Le systme ne doit tre nettoy quavec les solutions recommandes (voir page 147). Lutilisation dautres solutions peut provoquer un dysfonctionnement voire une panne du systme. Ne laissez pas des solutions de nettoyage pntrer dans l'instrument. Veillez bien faire scher le lecteur aprs tout nettoyage ou dsinfection. Bloc-piles Le lecteur contient un bloc-piles rechargeable qui se recharge ds que l'adaptateur est connect ou que le lec-
teur est plac sur une station d'accueil active (c'est--dire qu'elle est connecte l'alimentation). MISE EN GARDE Utilisez uniquement les blocs-piles spcialement conus et fournis par Roche Diagnostics. L'utilisation de tout autre type de pile pourrait endommager le systme. AVERTISSEMENT Dangers pouvant tre lis au bloc-piles Un bloc-piles endommag ou gonfl peut surchauffer, s'enflammer ou fuir. Arrtez immdiatement l'utilisation du lecteur CoaguChek Pro II si le bloc-piles est endommag ou gonfl et ne le rechargez sous aucune circonstance (ne le placez pas dans la station d'accueil). En cas de surchauffe, le bloc-piles peut s'enflammer ou exploser. Ne jetez jamais le bloc-piles ou le lecteur au feu. Abstenez-vous de dmonter, compresser, ou percer le bloc-piles car cela provoquerait un court-circuit interne, puis une surchauffe. Ne placez ni le bloc-piles, ni le lecteur CoaguChek Pro II sur ou dans les appareils chauffants, tels que les fours micro-ondes, fours traditionnels ou radiateurs. Ne laissez pas le lecteur expos la lumire directe du soleil, notamment lorsque celui-ci est insr dans la station d'accueil. Gardez cela l'esprit au moment de positionner la station d'accueil. Les liquides ou matriaux provenant de la fuite d'un bloc-piles endommag peuvent irriter votre peau et pro-
voquer des brlures en raison des tempratures leves. vitez tout contact avec le liquide rsultant d'une fuite de la pile. En cas de contact accidentel avec la peau, rincez l'eau. En cas de projection de liquide de pile dans les yeux, consultez galement un mdecin. Manipulez les blocs-piles avec prcaution et jetez-les selon les rglementations en vigueur. Des tempratures extrmes rduisent la capacit de charge et la priode d'utilisation du lecteur et du bloc-piles. 19 1 n o i t c u d o r t n I 20 Interfrences lectromagntiques Respectez les consignes gnrales de scurit suivantes relatives la manipulation du bloc-piles :
Mise au rebut des blocs-piles usags Ne jetez pas les blocs-piles avec les dchets domestiques normaux. Jetez les blocs-piles usags conformment aux rglementations, directives locales et consignes de votre tablissement relatives la mise au rebut des dchets d'quipements lectroniques. Lors du stockage ou de la mise au rebut du bloc-piles, veuillez utiliser l'emballage original du fabricant. Sauvegardez ou tlchargez les donnes du lecteur avant de procder au remplacement du bloc-piles, afin d'viter la perte de donnes (voir chapitre 7). teignez toujours le lecteur avant de retirer le bloc-piles. Lorsque l'avertissement Batterie faible s'affiche, le lecteur doit tre replac le plus vite possible sur la station d'accueil ou connect l'adaptateur pour tre recharg. Lorsque la capacit de la batterie est trop faible pour poursuivre les tests, le lecteur doit tre imm-
diatement replac sur la station d'accueil ou connect l'adaptateur pour tre recharg. Le lecteur rpond aux exigences de la norme IEC 61326-2-6 concernant les interfrences mises et l'immunit aux interfrences. N'utilisez pas le lecteur prs de champs lectromagn-
tiques importants qui pourraient interfrer avec son utilisation. Les dcharges lectrostatiques peuvent entraner un dysfonctionnement du lecteur. 21 cran tactile MISE EN GARDE Ne touchez les lments de l'cran qu' l'aide de votre doigt (mme si votre main est gante) ou de stylets spciaux pour cran tactile. Lutilisation dobjets pointus ou coupants peut endommager la surface de lcran. vitez toute exposition prolonge et directe la lumire du soleil. Le rayonnement direct du soleil peut rduire la longvit et la fonctionnalit de l'cran. Rseau local: protection contre l'accs non autoris Si ce lecteur est connect un rseau local, le rseau doit tre protg contre l'accs non auto-
ris. Il est particulirement important de ne pas le relier directement un autre rseau ou l'Internet. Les clients sont responsables de la scurit de leur rseau local et doivent en particulier le protger contre les logiciels malveillants et les attaques. Ils doivent donc prendre des mesures, telles qu'un pare-feu, visant protger l'appareil de rseaux non contrls, ainsi que des mesures assurant l'absence de code malveillant sur le rseau connect. Si vous utilisez une solution personnalise de systme de gestion des donnes, assurez-vous que les donnes sensibles transmises via l'interface POCT1-A sont protges par des mesures de scurit appropries. Assurez-vous que l'instrument est protg contre l'accs non autoris et le vol. N'utilisez pas de comptes d'utilisateurs partags sur le lecteur, le SGD et le rseau. Que vous travailliez dans un environnement filaire ou sans fil, utilisez un mot de passe fort pour les comptes utilisateurs sur le lecteur, le SGD et le rseau. Veuillez respecter les directives de votre tablissement concernant la gestion des mots de passe ou appliquer les rgles pour les mots de passe forts, voir Caractristiques d'un mot de passe fort ci-dessous. 1 n o i t c u d o r t n I 22 Connexion au rseau cbl Si la station d'accueil de Roche Diagnostics est utilise pour connecter ce lecteur un rseau local, elle doit tre protge contre l'accs non autoris l'aide d'une ges-
tion par mot de passe fort. Veuillez respecter les direc-
tives de votre tablissement concernant la gestion des mots de passe ou appliquer les rgles suivantes :
Caractristiques d'un mot de passe fort Le mot de passe ne doit pas contenir l'identifiant de l'utilisateur ou plus de deux caractres conscutifs du nom de l'utilisateur. Le mot de passe doit contenir au moins huit caractres. Le mot de passe doit contenir des caractres des trois catgories suivantes :
Caractres latins alphabtiques majuscules
(A Z) Caractres latins alphabtiques minuscules
(a z) Caractres numriques (0 9) Exemples de mots de passe faibles uhxwze11 ne contient pas de majuscules. UHXW13SF ne contient pas de minuscules. uxxxxx7F contient plus de quatre fois le mme caractre. x12useridF contient plus de quatre caractres de l'identifiant utilisateur. Connectivit sans fil Si le lecteur est quip d'une fonctionnalit WLAN :
La connectivit WLAN permet au lecteur d'envoyer des donnes (rsultats de test, identifiants patient et utilisa-
teur, etc.) au systme de gestion des donnes sans avoir besoin de replacer le lecteur sur la station d'accueil. Cette fonction doit tre configure par l'administrateur systme. Respectez les consignes de votre tablissement concer-
nant l'utilisation de connexions au rseau local sans fil. Une description de la capacit du lecteur CoaguChek Pro II se connecter aux rseaux locaux sans fil (WLAN, Wi-Fi) est disponible l'annexe C.1. Informations relatives l'exposition aux rayonnements de radiofrquences Glossaire :
FCC signifie Federal Communications Commission (tats-Unis). RF signifie radiofrquence . CNR signifie Cahier des charges sur les normes radiolectriques (Canada). WLAN signifie rseau local sans fil . 23 1 n o i t c u d o r t n I 24 Les radiofrquences ISM (Industriel, Scientifique et Mdical) peuvent contenir des missions provenant de fours micro-ondes, radiateurs et autres dispositifs non lis aux communications. Si ces dispositifs ne posent gnralement aucun problme d'interfrence en raison de leur faible puissance, il est toutefois possible que cer-
tains systmes industriels haute puissance liminent toute tentative d'tablir une communication partir d'un WLAN. Par consquent, il convient d'effectuer une tude du site et une analyse des interfrences l'aide d'un ana-
lyseur de spectre, afin de visualiser l'intgralit du spectre et de rechercher les signaux pouvant se trouver non seu-
lement dans la gamme de frquence du WLAN dsir, mais aussi ceux situs proximit ou la mme fr-
quence et pouvant provoquer des interfrences. Roche Diagnostics respecte les normes de rseau sans fil du secteur et recommande l'utilisation de produits poss-
dant la certification Wi-Fi. Cette certification est dlivre la suite de tests sur les produits, conformment aux normes industrielles 802.11, pour la connexion de base, la scurit, l'authentification, la qualit de service, l'inter-
oprabilit et la fiabilit. Le logo Wi-Fi CERTIFIED garantit que la Wi-Fi Alliance a test un produit selon plusieurs configurations et l'aide d'un chantillonnage vari com-
pos d'autres dispositifs, en vue d'assurer la compatibilit avec d'autres quipements labelliss Wi-Fi CERTIFIED et fonctionnant dans la mme bande de frquence. Le rseau Wi-Fi Alliance de laboratoires de tests indpendants lance des programmes de tests d'interoprabilit visant assurer que les dispositifs sans fil sont compatibles et prennent en charge des connexions scurises. Le systme CoaguChek Pro II rpond aux limites d'expo-
sition aux rayonnements tablies par la FCC pour un environnement non contrl. Lors de l'installation et de l'opration de cet quipement, vous devez maintenir une distance minimale de 20 cm entre le radiateur et votre corps. Cet metteur ne doit pas tre install ou utilis conjointe-
ment avec tout autre metteur ou antenne. Toute transformation ou modification effectue sur cet quipement non expressment approuve par Roche Diagnostics peut annuler l'autorisation donne par la FCC d'utiliser l'quipement. Ce dispositif satisfait la partie 15 du rglement de la FCC et la norme CNR-210 d'Industrie Canada. L'utilisa-
tion est soumise aux deux conditions suivantes :
(1) ce dispositif ne peut pas causer d'interfrences nuisibles, et
(2) ce dispositif doit accepter toute interfrence reue, y compris les interfrences qui peuvent entraner un fonctionnement indsirable. 25 1 n o i t c u d o r t n I 26 Le systme CoaguChek Pro II satisfait aux exigences rela-
tives l'immunit et aux missions dcrites dans la norme NF EN 61326-2-6. Il a t conu et test conformment la norme CISPR 11 de classe B. Cet quipement a t test et dclar conforme aux limites pour dispositifs numriques de classe B, selon la section 15 du rglement de la FCC. Ces limites sont des-
tines fournir une protection raisonnable contre les interfrences nuisibles dans une installation rsidentielle. Cet quipement gnre, utilise et peut mettre de l'ner-
gie de radiofrquence et, s'il n'est pas install et utilis conformment aux instructions, peut causer des interf-
rences nuisibles aux communications radio. Cependant, il n'est pas garanti qu'il ne causera pas d'interfrences dans une installation donne. Si cet quipement cause des interfrences nuisibles la rception de la radio ou du tlviseur, ce que vous pouvez dterminer en teignant et rallumant l'appareil, essayez de corriger ces interfrences en prenant une ou plusieurs des mesures suivantes :
Rorientez ou repositionnez l'antenne de rception. Augmentez la distance entre l'quipement et le rcepteur. Branchez l'quipement sur une prise de courant qui se trouve sur un circuit diffrent de celui auquel le rcepteur est branch. Informez-vous auprs du dtaillant ou d'un techni-
cien spcialis en radios/tlviseurs pour obtenir de l'aide. Cet appareil numrique de classe B est conforme la norme NMB-003 du Canada. Conditions dutilisation Afin de garantir le bon fonctionnement du lecteur, veillez respecter les consignes suivantes :
Contrle qualit N'utilisez le lecteur qu une temprature ambiante comprise entre 12 C et 32 C (54 F et 90 F). L'humidit relative doit tre comprise entre 10 % et 85 % (sans condensation). Si vous utilisez le lecteur avec ladaptateur secteur, veillez ce que la tension dalimentation soit situe entre 100 V et 240 V ( 10 %), 50/60 Hz. Pour effectuer la mesure, posez le lecteur sur une surface plane exempte de vibrations ou tenez-le l'horizontale. Le lecteur dispose d'une srie de fonctionnalits intgres pour le contrle qualit :
Vrification des composantes et des fonctions lectroniques la mise sous tension du lecteur. Vrification de la temprature de la bandelette-test au cours de la mesure. Vrification de la date de premption et des infor-
mations relatives la bandelette-test du lot en fonction des donnes de la puce d'talonnage. Contrle qualit intgr de chaque bandelette-test. Roche Diagnostics propose des contrles de qualit liquides pour le systme CoaguChek Pro II. Ces contrles sont conus pour assurer la conformit la rglementa-
tion en vigueur dans votre tablissement. 27 1 n o i t c u d o r t n I 28 1.3 Aperu des lments du lecteur B A C D E F E G H I J A B C D E F G H I J cran tactile Affiche les rsultats de test, informa-
tions, symboles et mesures enregistres en mmoire. Pour slectionner une option, il vous suffit d'effleurer la touche correspondante. Touche Marche/Arrt Appuyez sur cette touche pour allumer ou teindre le lecteur. Couvercle de la glissire d'insertion des bandelettes-test tez ce couvercle pour nettoyer la glissire d'insertion des bandelettes-test
(par exemple, si elle prsente des traces de sang). Glissire d'insertion des bandelettes-test Introduisez la bandelette-test cet endroit. Lecteur de code-barres Le lecteur de code-barres intgr permet de scanner les identifiants d'utilisateurs, de patients et d'chantillons de CQ. Couvercle du logement des piles Retirez ce couvercle pour insrer le bloc-piles. Connecteurs de chargement Utiliss pour l'alimentation lectrique et/
ou le chargement du bloc-piles lorsque le lecteur est insr dans la station d'accueil (en option). Fente d'insertion de la puce d'talonnage (reprsente avec la puce d'talonnage) Insrez la puce d'talonnage cet endroit. Connecteur pour l'adaptateur secteur Insrez l'adaptateur cet endroit. Port infrarouge
(recouvert par le panneau semi-
transparent). Prend en charge la communication de donnes. 29 1 n o i t c u d o r t n I 30 1.4 Aperu des touches et des symboles Voici la liste des diffrentes touches et symboles affichs lcran en cas de fonctionnement normal du lecteur, accompagns de leurs significations respectives. Les messages d'erreur et la description des symboles correspondants sont indiqus dans un chapitre consacr. Veuillez vous reporter la section Dpannage partir de la page 155. Touche/symbole Signification Accder au menu principal OK, enregistrer les rglages Annuler, ne pas enregistrer les rglages Retour (au menu prcdent) Diminuer/Augmenter la valeur affiche. Faire dfiler les listes trop longues pour tre entirement affiches. Touche inactive :
la valeur ne peut plus tre diminue/augmente ou la fin de la liste est atteinte dans cette direction Liste des mesures pour un patient donn Imprimer aprs le rsultat d'un test ou depuis la mmoire Affiche le rsultat de test sous forme de code QR. Ajouter un commentaire L'utilisateur doit attendre que le lecteur ait termin l'action. Insrer la bandelette-test Retirer la bandelette-test Touche/symbole Signification Dposer lchantillon (le temps restant est dcompt l'cran) Dposer lchantillon de contrle liquide (CQ) (le temps restant est dcompt l'cran) Introduire la puce d'talonnage de la bandelette-test QC Introduire la puce dtalonnage du CQ QC
%Q SEC INR Le contrle qualit automatique sest droul avec succs. Les rsultats du temps de Quick sont exprims sous la forme d'un pourcentage. Les rsultats du temps de Quick sont exprims en secondes. Les rsultats sont affichs en units INR (rapport normalis international). Les rsultats, dans lunit de mesure choisie, se situent au-dessus de lintervalle de mesure. Les rsultats, dans lunit de mesure choisie, se situent au-dessous de lintervalle de mesure. Contrle qualit : le rsultat se situe au-dessus de lintervalle spcifi. Contrle qualit : le rsultat se situe au-dessous de lintervalle spcifi. tat des piles :
Lorsque le bloc-piles est compltement charg, tous les segments sont affichs. Les segments disparaissent les uns aprs les autres au fur et mesure de lutilisation du bloc-piles. Lorsqu'il ne reste qu'un seul segment, l'icne s'affiche en rouge. Si lcran naffiche plus aucun segment, vous ne pourrez peut-tre pas terminer le test. Rechargez ds que possible. Fonctionnement sur adaptateur secteur 31 1 n o i t c u d o r t n I 32 Touche/symbole am pm Signification Entre minuit et midi (systme horaire de 12 heures) Entre midi et minuit (systme horaire de 12 heures) La temprature ambiante ou la temprature du lecteur se situe en dehors de lintervalle acceptable. Le couvercle de la glissire d'insertion des bandelettes-test est ouvert. Message de statut (voir : chapitre 9, Dpannage) Message d'erreur ou avertissement (voir : chapitre 9, Dpannage) QC!
Blocage ; un ou plusieurs paramtres sont bloqus. Les symboles suivants peuvent s'afficher lorsque le lec-
teur est utilis conjointement au systme de gestion des donnes (SGD). Touche/symbole Signification Une communication est en cours via le port infrarouge. Si ce symbole est affich dans la barre d'tat : une communication est en cours via le WLAN Si ce symbole est affich sur la touche Test Patient : blocage de la connectivit, seuls les tests URG sont possibles Une demande d'OTS est en attente Nettoyage/dsinfection ncessaire Le rsultat de mesure patient est hors de l'intervalle normal de mesure patient 1.5 Alimentation Le lecteur CoaguChek Pro II fonctionne l'aide d'un bloc-
piles rechargeable. Insrez le bloc-piles lorsque vous uti-
lisez l'adaptateur secteur. Vous serez ainsi assur de ne pas perdre les paramtres de date et d'heure en cas de panne de courant. L'adaptateur sert galement de chargeur pour le bloc-piles. Le lecteur CoaguChek Pro II dispose d'une fonction de mise hors tension automatique (Arrt Auto) permettant de rduire la consommation d'nergie. Le rglage par dfaut est de 5 minutes d'inactivit (par exemple, lorsque vous ne touchez pas l'cran). Il est possible de person-
naliser la fonction Arrt Auto en accdant aux Rglages
(consultez Arrt Auto , page 62). Lorsque le lecteur s'teint, tous les rsultats sont auto-
matiquement enregistrs dans la mmoire. 33 1 n o i t c u d o r t n I 34 Menu Princ. 09:15 Pendant le fonctionnement sur piles, le lecteur affiche en permanence le niveau de charge des piles. Test Patient Test de CQ Examen rsultats Rglages Lors du remplacement du bloc-piles, insrez le nou-
veau bloc-piles dans les 24 heures suivant le retrait de l'ancien, sans quoi vous devrez probablement saisir la date et l'heure nouveau. Le lecteur garde les rsultats en mmoire mme lorsqu'aucun bloc-piles n'est introduit. Tous les para-
mtres autres que la date et l'heure sont galement conservs. 29.05.2015 Jetez les blocs-piles usags en respectant l'environne-
ment et conformment la rglementation et aux direc-
tives locales en vigueur. Veuillez vous reporter la section Infection par un instrument prsentant un risque de danger biologique , page 18. 2 Mise en marche du lecteur Avant la premire utilisation du lecteur, effectuez les manipulations suivantes :
1 2 3 4 Installez le bloc-piles Connectez l'adaptateur secteur pour charger le bloc-piles Rglez la date et l'heure Saisissez les paramtres souhaits (langue, unit de mesure, administration de l'utilisateur le cas chant, etc.) 35 2 r u e t c e l u d e h c r a m n e e s i M 36 2.1 Installation ou remplacement du bloc-piles Lorsqu'il est expdi, le bloc-piles n'est pas install dans le lecteur CoaguChek Pro II. Les blocs-piles non utiliss se dchargent au fil du temps et doivent tre rechargs avant de pouvoir tre utiliss. Suite l'installation d'un nouveau bloc-piles, le lecteur doit tre charg pendant deux heures avant de procder un test. Veuillez noter que le bloc-piles n'atteindra sa capacit maximale qu'aprs avoir t compltement dcharg puis recharg plusieurs reprises. Ds que le lecteur est plac sur une station d'accueil active ou qu'il est aliment par un adaptateur secteur, le symbole s'affiche. Ce symbole indique que le courant est disponible et que le lecteur peut tre charg si ncessaire. Assurez-vous que la plage de tempratures autorise pour le chargement du bloc-piles (12 32 C ou 54 90 F) est maintenue pendant l'installation et la configuration initiale. Retrait du bloc-piles 1 2 Si un bloc-piles est dj install, veillez ce que le lecteur soit teint. Placez la face avant du lecteur contre une surface plane. 3 4 5 l'aide d'un tournevis toile appropri, p. ex. Torx taille T5, retirez les 4 vis du couvercle de logement des piles. Retirez le couvercle de logement des piles du lec-
teur. Le bloc-piles dsormais visible est connect au lecteur par une fiche. Soulevez dlicatement le bloc-piles et dbranchez la fiche de connexion. Mise au rebut des blocs-piles usags Ne jetez pas les blocs-piles avec les dchets domestiques normaux. Jetez les blocs-piles usags conformment aux rglementations, directives locales et consignes de votre tablissement relatives la mise au rebut des dchets d'quipements lectroniques. 37 2 r u e t c e l u d e h c r a m n e e s i M 38 Installation du bloc-piles 1 Desserrez les vis du couvercle de logement des piles jusqu' ce qu'elles dpassent de 4 5 mm. 2 Tenez le bloc-piles dans votre main, en pinant les fils et la fiche entre le pouce et l'index. 3 4 Branchez la fiche de connexion dans la prise. Placez le bloc-piles dans le logement des piles comme prsent prcdemment. Pour positionner le bloc-piles correctement, il convient d'aligner les artes situes sur le ct du bloc-piles avec celles se trouvant l'intrieur du logement des piles. 39 2 r u e t c e l u d e h c r a m n e e s i M 5 6 Placez le couvercle sur le logement des piles. Assurez-vous que :
les fils de la fiche de connexion ne se retrouvent pas coincs entre le lecteur et le couvercle. le crochet du couvercle de logement des piles s'insre dans l'orifice correspondant sur le bord du logement des piles Vissez les quatre vis jusqu' ce que le couvercle soit ajust (ne serrez pas trop les vis). 40 Date 09:15 Anne : 2015 Mois :
Jour :
5 Heure 29 Heure :
29.05.2015 Minute :
9 59 09:15 am pm 29.05.2015 Suite l'insertion du nouveau bloc-piles, le lecteur s'allume automatiquement. 7 Le logo Roche s'affiche. Si le lecteur ne s'allume pas automatiquement, il se peut que le bloc-piles soit vide. Connectez l'adaptateur secteur pendant au moins 30 minutes, puis retirez la fiche et essayez d'allumer le lecteur. Si celui-ci s'allume, le bloc-
piles charge correctement. Peu de temps aprs, l'cran de dmarrage devrait s'afficher. Si le lecteur est rest sans alimentation pendant trop longtemps, la bote de dialogue des para-
mtres de date et d'heure s'affichera et vous aurez les rgler nouveau. Les crans pour saisir la date et l'heure s'affichent. Saisissez la date et l'heure. Aprs avoir saisi les informations adquates, confirmez chaque cran l'aide de la touche
. Suite l'installation d'un nouveau bloc-piles, le lecteur doit tre charg pendant deux heures avant de procder un test. 2.2 Mise sous tension et hors tension du lecteur 1 2 Placez le lecteur sur une surface plane et exempte de vibrations ou tenez-le l'horizontale. Allumez le lecteur en appuyant sur le bouton
. Vous pouvez galement allumer le lecteur directement en insrant une bandelette-test, en connectant l'adap-
tateur secteur ou en le plaant sur la station d'accueil. 3 Pour teindre le lecteur aprs utilisation, appuyez sur la touche pendant environ 1 seconde. Vrification de la version du logiciel Init CoaguChek 04.00.00 Aprs avoir affich le logo Roche, le lecteur affiche brivement l'cran Init ( initialisation ). Vous pouvez alors vrifier quelle version de logiciel votre lecteur utilise.
(L'cran Init affich ci-contre a une vise illustrative uniquement. Les numros de versions peuvent tre diffrents sur votre lecteur.) 41 2 r u e t c e l u d e h c r a m n e e s i M 42 Cette page est intentionnellement laisse blanche. 3 Configuration du lecteur Remarque concernant la prsentation des lments apparaissant l'cran du prsent manuel Les touches sont des invites apparaissant l'cran et ragissant quand on les effleure. Le nom des touches apparat en gras ou est reprsent par le symbole utilis sur la touche (par exemple, pour OK). Les autres lments de l'cran (les noms des menus par exemple) sont crits en italique. Ces lments ne sont pas actifs. Si la date et l'heure ne sont pas rgles (aprs la pre-
mire mise en service ou si le lecteur est rest plus de 10 minutes sans alimentation), il est impossible deffec-
tuer une mesure. Dans ce cas, le fait dallumer lappareil mne obligatoirement au mode Rglages o vous devez rgler la date et lheure (voir page 53 et suivantes). Une fois que la date et l'heure sont rgles, le lecteur mne automatiquement au Menu Princ., o vous pouvez dmarrer un test ou saisir davantage de paramtres. Vous pouvez ouvrir chacune des fonctions affiches en effleurant la zone de fonction correspondante avec le doigt (ou avec un stylet prvu cet effet). Par effleurer, on entend toucher lgrement le bouton puis retirer le doigt de l'cran tactile. L'cran suivant apparat une fois que vous avez t votre doigt de l'cran. Si le lecteur nest pas automatiquement pass en mode Rglages (par exemple, aprs un changement de bloc-
piles), vous pouvez accder au Menu config. partir du Menu Princ. 43 3 r u e t c e l u d n o i t a r u g i f n o C 1 2 Effleurez l'lment Rglages pour accder aux paramtres du lecteur. Slectionnez le groupe de paramtres correspon-
dant (voir le rsum des rglages ci-dessous). 44 Menu Princ. 09:15 Test Patient Test de CQ Examen rsultats Rglages 29.05.2015 Menu con g. 09:15 cran Options Rglage ID Rglages CQ Diagnostics 29.05.2015 3.1 Rsum des rglages Le diagramme suivant vous donne un aperu des diffrents rglages possibles sur le lecteur. Rglages cran Contraste Con rmation rsultats Date / Heure Unit des rsultats Choix de la langue Options Rglage ID Tri Arrt Auto Slection paramtres Avert. sonore Connexion Admin. Utilisateur Patient Rglages CQ Intervalle CQ Blocages Numriser matriel CQ Diagnostics Gnral Matriel Rglages sans l Logiciel Mmoire occupe 45 3 r u e t c e l u d n o i t a r u g i f n o C 46 Groupe cran Rglage Sous-groupe Contraste Unit des rsultats Confirmation rsultats Choix de la langue Date/Heure Date Heure Format date Format heure Valeurs *
0 10 (5 *) INR *
INR/SEC INR/%Q Activer Dsactiver *
Dansk Deutsch English *
Espaol Franais Italiano Nederlands Norsk Portugus Suomi Svenska 01/01/2015 *
12:00 am *
JJ.MM.AAAA (01.01.2015) MM/JJ/AAAA (01/01/2015) *
AAAA-MM-JJ (2015-01-01) Format 24 heures (24h) Format 12 heures (12h) accompagn de am/pm *
* Les paramtres par dfaut sont suivis d'un astrisque (*). Groupe Options Sous-groupe Tri Rglage Avertisseur sonore Avertisseur sonore Bip Touche Arrt Auto
[minutes]
Connexion Code QR Slection paramtres Admin. (Administrateur) Utilisateur (la liste d'utilisateurs est facultative) Patient Rglage ID Valeurs *
Date/Heure *
ID patient Nom patient Off Bas Moyen *
lev Off *
On Off 1 (5*) 10 15 20 25 30 40 50 60 Off *
PC Imprimante Off *
On Activer Dsactiver *
Vide (Arrt) *
Dsactiver *
Activer Non *
Option Requis
* Les paramtres par dfaut sont suivis d'un astrisque (*). 47 3 r u e t c e l u d n o i t a r u g i f n o C 48 Groupe Sous-groupe Rglages CQ Intervalle CQ Blocages Diagnostics Numriser matriel CQ Gnral Logiciel Matriel Mmoire occupe Rglages sans fil Rglage PT aPTT Blocage Util.
(seulement si l'option Utilisateur est dfinie sur Activ et qu'une liste d'utilisateurs est disponible) Blocage CQ Config. test URG. Valeurs *
Intervalle dfaut*
Intervalle person. Off *
Hebdomadaire Mensuel Trimestriel Semestriel Annuel Nbre Niveaux Nouv. Code (Oui/Non) Programm Non*
Quotidien Hebdomadaire Mensuel Nombre d'heures Nombre bandelettes Pour chaque option except l'option Non :
Nbre Niveaux (1/2) Activer Dsactiver *
Quantit Option *
Lecture seulement
* Les paramtres par dfaut sont suivis d'un astrisque (*). 3.2 Rglages cran Contraste La zone de rglage cran contient les options permettant de modifier l'affichage. Utilisez le menu Contraste pour ajuster l'affichage la lumire ambiante et faciliter la lecture. Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Contraste. Une touche grise indique que la fonction n'est pas disponible. Contraste 09:15 Contraste (0-10) :
5 29.05.2015 4 5 ou pour choisir une valeur de Effleurez contraste comprise entre 0 et 10. Le contraste 0 donne un affichage trs fonc. Le contraste 10 donne un affichage trs clair. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer 49 3 r u e t c e l u d n o i t a r u g i f n o C 50 Unit des rsultats Ce paramtre vous permet de slectionner l'unit dans laquelle les rsultats seront affichs. Ce paramtre s'applique seulement aux rsultats de test PT. Indpen-
damment des paramtres choisis pour le PT, l'aPTT s'affiche toujours en secondes. Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Unit des rsultats. Le paramtre actuel de l'unit de mesure est en sur-
brillance (blanc sur fond bleu). Le lecteur offre les options suivantes :
4 5 INR INR et temps de Quick exprim en secondes (SEC) INR et temps de Quick exprim en pourcentage
(%Q) Slectionnez les units de mesure de votre choix en effleurant la zone correspondante. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Units 09:15 INR INR/SEC INR/%Q 29.05.2015 Confirmation rsultats Dans certaines situations, il peut tre utile que les utilisateurs confirment la validit de leurs rsultats. Ce menu vous permet d'inviter les utilisateurs confirmer les rsultats de chaque test. Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Confirmation rsultats. Effleurez Activer ou Dsactiver. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Con rmation rsultats 09:15 Activer Dsactiver 29.05.2015 51 3 r u e t c e l u d n o i t a r u g i f n o C 52 Choix de la langue Ce paramtre vous permet de slectionner la langue du lecteur. Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Choix de la langue. Le paramtre actuel de langue est en surbrillance (blanc sur fond bleu). Le lecteur offre les options suivantes :
Dansk Deutsch English Espaol Franais Italiano Nederlands Norsk Portugus Suomi Svenska Langue 09:15 Dansk Deutsch English Espaol Franais 29.05.2015 Rglage de la date 4 Effleurez ou choix l'cran. pour afficher la langue de votre Si la flche est transparente vous avez atteint la fin de la liste.
, cela signifie que 5 6 Effleurez la touche pour slectionner la langue de votre choix. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Si vous utilisez lappareil pour la premire fois (ou sil est rest longtemps hors service), la zone de rglage de la date saffiche automatiquement. Si la date et lheure nont pas t rgles, il est impossible de passer aux fonctions suivantes. Si un ajustement de la date est ncessaire plus tard, accdez au Menu config. puis slectionnez le menu de votre choix. Les formats d'affichage Date et Heure sont contrls par les options Format slectionnes (voir page 56). Les options des menus Date et Heure peuvent varier en fonction des formats choisis. Vous pouvez choisir les formats suivants :
Date : Jour.Mois.Anne, par ex. 29.05.2015 Date : Mois/Jour/Anne, par ex. 05/29/2015 Date : Anne-Mois-Jour, par ex. 2015-05-29 Heure : 24h ou 12h 53 3 r u e t c e l u d n o i t a r u g i f n o C 54 Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 6 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Date/Heure. Dans le menu Date/Heure, effleurez l'lment Rgl. Date. Effleurez le jour. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer pour rgler lanne, le mois puis et Si vous avez t envoy automatiquement au menu config. lors de la mise sous tension du lecteur, vous devez terminer le rglage de la date en effleurant la zone
. 7 Effleurez pour revenir au menu cran. Date/Heure 09:15 Rgl. Date Rgl. Heure Format Date 09:15 Anne : 2015 29.05.2015 Mois :
Jour :
5 29 29.05.2015 Rglage de lheure Si vous utilisez lappareil pour la premire fois (ou sil est rest longtemps hors service), le menu Heure saffiche automatiquement aprs le rglage de la date. Si un ajus-
tement de l'heure est ncessaire plus tard, accdez au Menu config. puis slectionnez le menu de votre choix. Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 6 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Date/Heure. Dans le menu Date/Heure, effleurez l'lment Rgl. Heure. Effleurez les minutes. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer pour rgler les heures puis et Si vous avez t envoy automatiquement au menu config. lors de la mise sous tension du lecteur, vous devez terminer le rglage de l'heure en effleurant la zone
. Date/Heure 09:15 Rgl. Date Rgl. Heure Format 29.05.2015 Heure 09:15 Heure :
Minute :
9 59 am pm 7 Effleurez pour revenir au menu cran. 29.05.2015 55 3 r u e t c e l u d n o i t a r u g i f n o C 56 Rglage des options d'affichage de la date et de lheure Slectionnez le format de votre choix pour l'affichage de la date et de l'heure. Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics cran 09:15 Contraste Unit des rsultats Con rmation rsultats Choix de la langue Date / Heure 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment cran. Dans le menu cran, effleurez l'lment Date/Heure. Dans le menu Date/Heure, effleurez l'lment Format. Les paramtres actuels sont mis en surbrillance. Le lecteur offre les options daffichage suivantes :
Date : JJ.MM.AAAA (Jour.Mois.Anne), par ex. 29.05.2015 Date : MM/JJ/AAAA (Mois/Jour/Anne), par ex. 05/29/2015 Date : AAAA-MM-JJ (Anne-Mois-Jour), par ex. 2015-05-29 Heure : 24h ou 12h Effleurez les zones affichant le format de la date et de lheure dsir. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. Effleurez pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer pour revenir au menu cran. 5 6 7 Date/Heure 09:15 Rgl. Date Rgl. Heure Format 29.05.2015 Format 09:15 Date :
JJ.MM.AAAA MM/JJ/AAAA AAAA-MM-JJ Heure :
24H 12H 29.05.2015 57 3 r u e t c e l u d n o i t a r u g i f n o C 58 3.3 Rglage des options Tri La fonction Tri dtermine lordre daffichage des valeurs mesures et mmorises si vous utilisez la fonction Examen rsultats de votre lecteur CoaguChek Pro II. Vous avez la possibilit dafficher les valeurs enregistres dans la mmoire chronologiquement, selon la date et lheure denregistrement ou en fonction de l'ID patient. Menu Princ. 09:15 Menu con g. 09:15 Options 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Tri Avert. sonore Arrt Auto Connexion Slection paramtres 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Options. Dans le menu Options, effleurez l'lment Tri. Trier Trier par :
09:15 Date / Heure ID patient Nom patient 29.05.2015 Les paramtres actuels sont mis en surbrillance. Le lecteur offre les options de tri suivantes :
4 Par Date/Heure Par ID patient Par Nom patient Effleurez la zone du mode de tri dsir. Votre slection est dsormais en surbrillance. Loption de tri Nom patient nest disponible quen asso-
ciation avec une liste de patients. Les listes de patients ne peuvent tre cres quavec un SGD. Pour davantage de dtails, reportez-vous la section Manipulation des donnes partir de la page 139. 5 pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. 59 3 r u e t c e l u d n o i t a r u g i f n o C 60 Avertisseur sonore Le lecteur CoaguChek Pro II peut afficher des informa-
tions visuelles et vous signaler les vnements particu-
liers par le biais d'un avertisseur sonore. Le lecteur met toujours un signal sonore lorsqu'il est mis sous tension. Si la fonction Avert. son. est active, une tonalit se fait entendre dans les circonstances suivantes :
Quand le lecteur dtecte la prsence dune bandelette-test Quand le prchauffage de la bandelette-test est termin et quun chantillon de sang doit tre dpos Quand le lecteur dtecte la prsence dun chantillon de sang Quand la mesure est termine et que le rsultat saffiche (bip long) Quand une erreur sest produite (trois bips brefs) Quand un adaptateur secteur externe est connect et quand le lecteur est sous tension Quand le lecteur est plac sur son socle Quand un code-barres est scann Nous vous recommandons de laisser l'avertisseur sonore activ tout moment. Vous avez galement la possibilit dactiver un bip touche. Lorsque le bip touche est activ, le lecteur met un son bref pour chaque touche effleure, ce qui permet de faciliter la saisie d'informations. Menu Princ. 09:15 Menu con g. 09:15 Options 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Tri Avert. sonore Arrt Auto Connexion Slection paramtres 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Options. Dans le menu Options, effleurez l'lment Avertisseur sonore. Les paramtres actuels sont mis en surbrillance. Le lecteur offre les options suivantes :
Avert. son. 09:15 Pour l'avertisseur sonore Off Bas Moyen lev Bip Touche :
On Off 29.05.2015 Off Bas Moyen lev Pour le bip touche 4 5 On Off Effleurez la zone de rglage du signal sonore dsir pour l'avertisseur sonore puis choisissez la tonalit du bip touche. Les deux slections sont dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer 61 3 r u e t c e l u d n o i t a r u g i f n o C 62 Arrt Auto Votre lecteur CoaguChek Pro II peut tre rgl de manire steindre automatiquement si aucune action
(bouton press ou mesure effectue) na t effectue aprs un certain temps. Cette fonction permet de rduire la consommation dnergie et de prolonger la longvit du bloc-piles. Menu Princ. 09:15 Menu con g. 09:15 Options 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Tri Avert. sonore Arrt Auto Connexion Slection paramtres 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Options. Dans le menu Options, effleurez l'lment Arrt auto. Si le lecteur est connect l'adaptateur ou la station d'accueil, la fonction Arrt Auto a un effet diffrent :
Le lecteur s'teint aprs 10 minutes d'inactivit, quel que soit le rglage slectionn. Arrt Auto 09:15 Minutes :
Le lecteur offre les options suivantes :
5 29.05.2015 Connexion 4 5 ou Off (le lecteur ne s'teint jamais tout seul) Dure aprs laquelle le lecteur s'teint tout seul :
110, 15, 20, 25, 30, 40, 50, 60 minutes Effleurez pour slectionner la dure de votre choix en minutes ou pour dsactiver la fonction. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Dans le menu Connexion, vous pouvez configurer l'change de donnes avec les dispositifs externes. Le lecteur peut tre connect soit un ordinateur (SGD), soit une imprimante. En plus de cette sortie de donnes directe, il est galement possible d'encoder les rsultats de test sous forme de codes QR que vous pouvez scanner pour les utiliser avec d'autres applications. Menu Princ. 09:15 Menu con g. 09:15 Options 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Tri Avert. sonore Arrt Auto Connexion Slection paramtres 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Options. Dans le menu Options, effleurez l'lment Connexion. 63 3 r u e t c e l u d n o i t a r u g i f n o C 64 Code QR Connexion 09:15 Code QR Code QR Af cher code QR :
09:15 On Off Off PC 4 5 Dans le menu Connexion, effleurez l'lment Code QR. Effleurez On pour activer l'affichage du code QR ou Off pour le dsactiver. Votre slection est dsormais en surbrillance. Si vous avez activ cette fonction, slectionnez le style du code QR afficher :
Imprimante Texte clair 29.05.2015 Donnes codes Transmission URL 29.05.2015 Texte clair Cette option sert scanner les rsultats vers une application hberge sur PC (p. ex. dossier mdical lectronique). Pour ce faire, un lecteur de codes-
barres 2D externe doit tre connect votre PC. Une fois scanns, les rsultats de test et les mta-
informations (p. ex. date, heure, commentaires) s'afficheront en texte clair dans votre application PC. Assurez-vous que votre environnement de lecture des codes QR (lecteur de code QR, systme d'exploitation, application de traitement de texte) correspond votre langue. Dans le cas contraire, votre composant de rception (PC, dispositif mobile) peut prsenter un comportement imprvisible. Donnes codes Cette option sert scanner les rsultats vers une application base sur smartphone ou sur tablette ou une application hberge sur PC. Transmission URL Cette option sert transfrer les rsultats vers un service bas sur le Web (p. ex. un dossier mdical lectronique, un logiciel de gestion de la coagula-
tion, etc.). Pour cette option, d'autres paramtres
(URL, cl de chiffrement) doivent tre dfinis. Des programmes logiciels ou des applications ddis sont requis dans le cadre de l'utilisation des options Donnes codes et Transmission URL. Si vous tes client ou fournisseur informatique tiers et que vous souhaitez utiliser cette fonction, contactez votre repr-
sentant Roche Diagnostics local pour obtenir de plus amples informations. 6 Effleurez Texte clair, Donnes encodes ou Transmission URL, selon l'utilisation prvue. Votre slection est dsormais en surbrillance. Code QR Af cher code QR :
09:15 On Off Texte clair Donnes codes Transmission URL Transmission URL 09:15 29.05.2015 URL Cl de chiffrement 29.05.2015 URL 09:15 A F K P U Z B G L Q V
. E J O T Y C H M R W
/
D I N S X 123 Si vous avez slectionn Transmission URL, le bouton s'activera. Dfinissez les paramtres supplmentaires l'aide de ce bouton. 7 8 9 pour ouvrir le menu Transmission URL. Effleurez Effleurez URL pour entrer l'URL vers laquelle les donnes des rsultats de test seront transfres
(remarque : l'URL vous sera fournie par votre fournisseur de services spcialiss). 123 ABC pour passer au mode de saisie de pour revenir au mode de saisie de Utilisez chiffres. Utilisez texte. Utilisez Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour effacer un caractre. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer 65 3 r u e t c e l u d n o i t a r u g i f n o C 66 Transmission URL 09:15 URL Cl de chiffrement 10 Effleurez Cl de chiffrement pour afficher le menu Cl de chiffrement. Le menu Cl de chiffrement affiche deux types d'informa-
tions ncessaires pour identifier et dcoder les rsultats de test transmis. Ces informations sont ncessaires au systme informatique auquel les rsultats de test sont transmis par le biais de l'URL dfinie. 09:15 L'utilisation de cette mthode de transmission par URL ne peut se faire que si ces informations ont t prala-
blement changes avec votre fournisseur de services spcialiss. Contactez ce dernier afin d'changer ces informations. 29.05.2015 Cl de chiffrement Cl :
JD5G29F6U8V2WC4L Num. de srie :
UQ85464711 Remarque : la cl de chiffrement et le numro de srie sont requis pour dchiffrer les messages du code QR depuis ce lecteur. Veillez ce quils soient disponibles sur le systme cible. 29.05.2015 11 12 Cl Cette cl est auto-gnre par le lecteur et elle est requise pour dchiffrer les informations du code QR. Num. de srie Le numro de srie du lecteur est requis pour mettre en correspondance les rsultats de test et la cl de chiffrement. Effleurez le bouton Nouv. si vous souhaitez que le lecteur gnre une nouvelle cl de chiffrement. deux fois pour revenir au menu Effleurez Code QR. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer PC Connexion 09:15 Code QR Off PC Imprimante 29.05.2015 Le lecteur CoaguChek Pro II peut se connecter un ordi-
nateur ou un systme hberg excutant un logiciel appropri (un SGD doit tre install). Nanmoins, pour utiliser cette fonction de connectivit, la station d'accueil optionnelle est ncessaire ou le lecteur doit tre confi-
gur pour une communication sans fil. Si aucune com-
munication sans fil n'est configure, la connexion s'tablit en deux tapes. Le lecteur se connecte la station d'accueil par infrarouge. La station d'accueil est soit connecte un ordina-
teur (via USB), soit un rseau/systme hberg
(via ethernet). L'option PC (lorsqu'elle est active) peut tre utilise avec un SGD pour dfinir :
la liste d'utilisateurs ou les listes de patients (listes de patients pour lesquels un test doit tre effectu) Il n'est donc plus ncessaire de saisir manuellement ces donnes. De plus, vous pouvez transfrer les rsultats de tests enregistrs dans le lecteur d'autres systmes des fins d'archivages ou d'valuation ultrieure. L'option PC contrle la capacit du lecteur communiquer avec un ordinateur ou avec un rseau. 13 14 Effleurez PC. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer la fonctionnalit tendue de manipulation des donnes dpend des capacits du systme de gestion des donnes (SGD) utilis. 67 3 r u e t c e l u d n o i t a r u g i f n o C 68 Imprimante Le lecteur CoaguChek Pro II peut galement tre directe-
ment connect une imprimante. Pour utiliser la fonction d'impression, vous avez besoin d'une imprimante infra-
rouge en option. Menu Princ. 09:15 Menu con g. 09:15 Options 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Tri Avert. sonore Arrt Auto Connexion Slection paramtres 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Options. Dans le menu Options, effleurez l'lment Connexion. Effleurez Imprimante. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Pour imprimer :
Connexion 09:15 Off PC Imprimante 29.05.2015 Mmoire 09:15 Alignez le lecteur avec l'imprimante infrarouge. Sur un cran test ou mmoire, effleurez
. ID P : PID01 Smith, Henry Util : Utilisateur 1 Par:
PT Code : 184 28.05.2015 11:31 2.5INR 21%Q Mdecin inform Malade En voyage 29.05.2015 l'icne d'imprimante n'apparat que si la fonction imprimante est active. Dans le cas contraire, elle ne s'affiche pas. Si vous utilisez le lecteur dans une langue autre que l'anglais : l'exception des informations que vous avez saisies (par exemple, un identifiant ou un nom de patient, un identifiant utilisateur ou des commentaires), le document imprim sera en anglais. (Veuillez vous reporter la section Choix de la langue , page 52.) Slection paramtres Lors de l'excution d'une mesure, il est possible de dfinir le lecteur de manire ce qu'il affiche un cran permet-
tant l'oprateur de slectionner le paramtre de test utiliser. Dans le cas contraire, le lecteur dterminera le paramtre de test en lisant les informations prsentes sur la bandelette-test (code-barres) insre. Menu Princ. 09:15 Menu con g. 09:15 Options 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Tri Avert. sonore Arrt Auto Connexion Slection paramtres 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Options. Dans le menu Options, effleurez l'lment Slection paramtres. Effleurez Activer pour afficher l'cran de slection de paramtres avant chaque test ou effleurez Dsactiver pour que le lecteur slectionne les paramtres en lisant les informations prsentes sur la bandelette-test. Effleurez effleurez les modifications. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Slect. Param. 09:15 Activer Dsactiver 29.05.2015 69 3 r u e t c e l u d n o i t a r u g i f n o C 70 3.4 Rglage ID Le menu Rglage ID propose diffrents modes de gestion
(gestion utilisateur, gestion patient) pour lutilisation du lecteur. Ces paramtres sont facultatifs et sont dfinis par dfaut sur Off/Dsactiver ; le lecteur peut en effet fonctionner sans ces paramtres. Il existe trois types d'identification pour l'utilisation du lecteur :
Administrateur systme : l'Admin. (administra-
teur) possde des droits particuliers lui permettant d'effectuer certains rglages de lecteur et il est le seul pouvoir saisir et modifier ces rglages. L'identification Admin. ne doit pas tre obligatoire-
ment active pour pouvoir utiliser le lecteur CoaguChek Pro II. Toutefois, cette fonction peut s'avrer ncessaire en fonction de l'environnement rglementaire du lieu d'utilisation. Utilisateur : l'ID utilisateur est attribu aux per-
sonnes utilisant le lecteur pour effectuer des tests. Si vous souhaitez utiliser les ID utilisateur, diff-
rentes options s'offrent vous :
Vous pouvez utiliser les ID utilisateur afin de limiter l'utilisation du lecteur au seul personnel qualifi ou un groupe prdfini d'utilisateurs. Dans ce cas, une liste d'utilisateurs cre en externe doit tre transfre vers le lecteur afin que vous puissiez slectionner un ID utilisateur lorsque vous vous connectez. Pour davantage de dtails, veuillez vous reporter la section Manipulation des donnes , partir de la page 139. Les ID utilisateur ne doivent tre utiliss qu' titre informatif afin d'attribuer des rsultats de mesure enregistrs aux utilisateurs ayant effectu le test. Dans ce cas, les ID utilisateur peuvent tre directe-
ment saisis sur le lecteur ( l'aide du clavier ou du scanner), sans avoir obligatoirement besoin de la liste d'utilisateurs. Patient : l'ID patient est attribu la personne dont les rsultats de test sont enregistrs. Vous pouvez :
bloquer la saisie d'un ID patient unique (dans ce cas, chaque test est numrot dans un ordre conscutif) dfinir un ID patient unique comme optionnel ou dfinir un ID patient unique comme obligatoire pour chaque test. Les listes de patients cres en externe peuvent galement tre transfres vers le lecteur afin que vous puissiez y slectionner un ID patient pour un test. Pour davantage de dtails, reportez-vous la section Manipulation des donnes partir de la page 139. Les ID utilisateur peuvent tre slectionns partir d'une liste (le cas chant) ; ils peuvent galement tre scanns au lecteur de code-barres sur le ct du lecteur. Si des mots de passe ont t crs, ils doivent tre saisis sur le clavier tactile apparaissant l'cran. Les ID patients peu-
vent tre saisis par le biais du clavier tactile apparaissant l'cran ou via le lecteur de code-barres sur le ct du lecteur. Pour plus d'informations sur l'utilisation des codes-barres d'identifiant patient ou utilisateur, veuillez consulter la section Manipulation des donnes , partir de la page 139. Les touches de menu Rglage ID affichent les para-
mtres actuels (l'illustration n'est donne qu' titre d'exemple, l'cran de votre lecteur peut revtir une apparence diffrente) :
Laffichage standard de la zone Admin. signifie que la fonction est disponible mais actuellement inactive (aucun mot de passe pour le systme administrateur/superviseur n'a t attribu). L'affichage standard de la touche Utilisateur signifie que l'ouverture d'une session Utilisateur est disponible mais non active. Lorsque la touche Patient est en surbrillance
(c'est--dire lorsqu'elle s'affiche sur un fond bleu), la fonction est disponible et active (qu'elle soit rgle sur Option ou Requis). 71 3 r u e t c e l u d n o i t a r u g i f n o C Rglage ID 09:15 Admin. Utilisateur Patient 29.05.2015 72 Administrateur systme (admin.) Dans le rglage par dfaut, le lecteur nest pas protg par un ID Admin. et les options de rglage sont accessibles tous les utilisateurs. Si vous dfinissez un ID Admin., les zones de rglages suivantes sont automa-
tiquement restreintes l'administrateur/au superviseur systme (c'est--dire la personne connaissant le mot de passe). cran : Unit des rsultats, Confirmation rsultats, Date/Heure Options : Connexion ( un ordinateur ou une imprimante) Rglage ID (tous paramtres) Rglages CQ (tous paramtres) Diagnostics : Logiciel, Matriel, Mmoire, Rglages sans fil Si vous saisissez un ID Admin., il devra tre saisi avant que les rglages mentionns ci-dessus ne puissent tre modifis. L'ID Admin. doit galement tre saisi avant de pouvoir tre supprim ou modifi. En cas d'oubli de l'ID Admin., veuillez contacter votre reprsentant Roche Diagnostics. Si aucun ID Admin. n'a encore t dfini :
Menu Princ. 09:15 Menu con g. 09:15 Rglage ID 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Admin. Utilisateur Patient 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglage ID. Dans le menu Rglage ID, effleurez l'lment Admin. Administrat.
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A 09:15 E J O T Y 4 Saisissez l'ID Admin. de votre choix l'aide du cla-
vier affich l'cran. L'ID peut comporter jusqu'
20 caractres. Soyez attentif aux touches que vous effleurez, les carac-
tres ne s'afficheront pas l'cran. Ils seront remplacs par des astrisques, tout comme pour la saisie d'un mot de passe l'ordinateur. B G L Q V C H M R W D I N S X 123 F K P U Z 0 5
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Administrat. 09:15 1 6 2 7 3 8 4 9 ABC D I N S X 123 09:15 E J O T Y Rpter ID
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A B G L Q V C H M R W F K P U Z 5 6 7 8 9 10 123 ABC pour passer au mode de saisie de pour revenir au mode de saisie de pour effacer un caractre. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Utilisez chiffres. Utilisez texte. Utilisez Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. Saisissez nouveau l'ID Admin. (le clavier saffiche une deuxime fois automatiquement l'cran) afin de confirmer la premire saisie. Effleurez est alors dfini) ou effleurez pour quitter ce menu (l'ID Admin. n'est alors pas dfini et reste donc inactif). pour enregistrer la saisie (l'ID Admin. Le programme revient automatiquement au menu Rglage ID. Une fois que vous avez quitt le Menu config., seul un administrateur authentifi peut modifier les zones de rglage telles qu'voques prcdemment
(voir page 72). 73 3 r u e t c e l u d n o i t a r u g i f n o C 74 Modification d'un ID admin. existant Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Administrat.
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A B G L Q V C H M R W D I N S X 123 F K P U Z Rglage ID 09:15 Admin. Utilisateur Patient 09:15 E J O T Y 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglage ID. l'aide du clavier affich l'cran, saisissez l'ID Admin. actuel. Le menu Rglage ID saffiche. La touche Admin. est en surbrillance, ce qui indique qu'un ID Admin. est activ. 4 5 Effleurez la zone Admin. Saisissez (et confirmez) le nouvel ID Admin. de votre choix l'aide du clavier affich l'cran. Dsactivation d'un ID Admin. existant :
Menu Princ. 09:15 Menu con g. 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Administrat.
***|
A B G L Q V C H M R W D I N S X 123 F K P U Z Rglage ID 09:15 Admin. Utilisateur Patient 09:15 E J O T Y 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglage ID. l'aide du clavier affich l'cran, saisissez l'ID Admin. actuel. Le menu Rglage ID saffiche. La touche Admin. est en surbrillance, ce qui indique qu'un ID Admin. est activ. 4 5 Effleurez la zone Admin. Effleurez immdiatement clavier affich l'cran sans saisir de mot de passe. afin de refermer le Rglage ID 09:15 Admin. Utilisateur Patient Administrat. 09:15
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L'ID Admin. a t supprim et est de ce fait dsactiv. La touche Admin. n'apparat plus en surbrillance. 29.05.2015 A F K P U Z B G L Q V C H M R W E J O T Y D I N S X 123 75 3 r u e t c e l u d n o i t a r u g i f n o C 76 Identifiant de lutilisateur Si vous souhaitez crer une liste d'ID utilisateur partir de laquelle vous pouvez slectionner un utilisateur, un logiciel supplmentaire (systme de gestion des donnes) ainsi que la station d'accueil vous seront ncessaires (pour davantage de dtails, voir la section Manipulation des donnes , partir de la page 139). L'ouverture de session Utilisateur est dsactive par dfaut. Vous pouvez choisir d'activer ou de dsactiver l'ouverture de session Utilisateur sur le lecteur. Si cette dernire est active, un utilisateur doit se connecter avant l'affichage du Menu Princ. pour pouvoir effectuer les mesures. Pour activer l'ouverture de sessions Utilisateur :
Menu Princ. 09:15 Menu con g. 09:15 Rglage ID 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Admin. Utilisateur Patient 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglage ID. Dans le menu Rglage ID, effleurez l'lment Utilisateur. Effleurez la zone affichant le rglage dsir pour configurer l'ouverture de session Utilisateur. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer ID utilisat. 09:15 Dsactiver Activer 29.05.2015 ID patient 77 Si vous souhaitez crer une liste d'ID patient dans laquelle vous pouvez slectionner un patient pour des tests, un logiciel supplmentaire (systme de gestion des donnes) ainsi que la station d'accueil seront ncessaires (voir page 139). Dans le rglage par dfaut, la saisie d'identifiants patient est dfinie sur Non. Ainsi, chaque test sera numrot de faon conscutive. Vous pouvez galement imposer la saisie dun ID Patient, ou la rendre optionnelle. Menu Princ. 09:15 Menu con g. 09:15 Rglage ID 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Admin. Utilisateur Patient 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglage ID. Dans le menu Rglage ID, effleurez l'lment Patient. ID patient 09:15 Le lecteur offre les options suivantes :
Non Option Requis 29.05.2015 4 5 Non (numrotation automatique des tests) Option (numrotation automatique ou liste/scan/saisie manuelle) Requis (liste/scan/saisie manuelle) Effleurez la zone avec le rglage dsir. Votre slection est dsormais en surbrillance. pour enregistrer ce rglage ou Effleurez effleurez pour quitter ce menu sans enregistrer les modifications. Pour loption Non, le rglage est ainsi termin. Pour les options Option et Requis, continuez pour slectionner le format daffichage. 3 r u e t c e l u d n o i t a r u g i f n o C 78 ID patient 09:15 Alphanum. Numrique Long. min. :
Long. max. :
1 20 29.05.2015 Slectionnez la forme de la saisie de l'ID Patient. 6 Le lecteur offre les options suivantes :
7 8 9 Alphanum. Saisissez une combinaison de lettres et chiffres, par ex. P.DUPONT 3378 Numrique Saisissez des chiffres uniquement, par ex. 3387 Long. min. Prcisez le nombre minimal de caractres (1 20) que l'ID patient doit comporter. Long. max. Prcisez le nombre maximal de caractres (1 20) que l'ID patient doit comporter. Effleurez la zone avec le format dsir pour les ID patient. Votre slection est dsormais en surbrillance. Effleurez caractres (longueur) de votre choix. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer pour dfinir le nombre de ou 79 3.5 Configuration Rglages CQ Le menu Rglages CQ comporte des options pour amliorer l'efficacit des contrles qualit liquides par l'utilisateur, des intervalles spcifis. Il permet gale-
ment de personnaliser l'intervalle CQ conformment aux rglementations locales en vigueur. Intervalle CQ Deux options s'offrent vous :
Intervalle dfaut : le lecteur affiche l'intervalle CQ fourni par Roche Diagnostics dans la puce d'talonnage. Intervalle person. : l'option Intervalle person. permet l'utilisateur de dfinir son propre intervalle CQ dans l'intervalle par dfaut. Blocages (blocage CQ et blocage d'utilisateur) Si le contrle qualit liquide nest pas effectu correcte-
ment ou si le rsultat se situe en dehors de lintervalle admissible, le lecteur est automatiquement verrouill. Le blocage peut galement tre rgl de faon slective pour chacun des utilisateurs. Le lecteur ne sera alors de nouveau disponible
(de manire gnrale ou pour lutilisateur) quaprs lexcution dun contrle qualit liquide. L'option consistant dfinir un Blocage Util. est uni-
quement disponible lorsque les listes utilisateur ont t cres dans un systme de gestion des donnes
(SGD), enregistres dans le lecteur, et que l'ouverture de session utilisateur est active. Ces listes sont unique-
ment disponibles lors d'une connexion avec un systme de gestion des donnes. Pour davantage de dtails, reportez-vous la section Manipulation des donnes partir de la page 139. Numriser matriel CQ Le lecteur de code-barres du lecteur CoaguChek Pro II peut tre utilis pour scanner les codes-barres des flacons de matriel CQ. Cette fonction peut tre dfinie sur Option ou Lecture seulement. Si la fonction est dfinie sur Lecture seulement, l'utilisateur ne pourra pas slec-
tionner manuellement un numro de lot de CQ partir d'une liste. 3 r u e t c e l u d n o i t a r u g i f n o C 80 Intervalle CQ Il est possible de personnaliser les intervalles de contrle qualit liquide afin de se conformer aux rglementations locales. La fonction Intervalle CQ vous permet de rduire l'intervalle par dfaut de manire individuelle pour chaque paramtre de test. Menu Princ. 09:15 Menu con g. 09:15 Rglages CQ 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Intervalle CQ Blocages Numriser matriel CQ 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglages CQ. Dans le menu Rglages CQ, effleurez l'lment Intervalle CQ. Dans le menu Intervalle CQ, effleurez le bouton du paramtre de test que vous souhaitez dfinir. Le lecteur offre les options suivantes :
5 Intervalle dfaut (l'intervalle fourni avec la puce d'talonnage est slectionn et s'affiche. Aucune valeur cible ne s'affiche.) Intervalle person. (le pourcentage de dviation autoris de la valeur cible peut dsormais tre per-
sonnalis. De plus, vous pouvez choisir d'afficher la valeur cible avec un rsultat de test de contrle ou non.) Effleurez la zone avec le rglage dsir. Votre slection est dsormais en surbrillance. Interv. CQ 09:15 PT aPTT Interv. CQ Par :
aPTT 09:15 29.05.2015 Intervalle dfaut Intervalle person. 29.05.2015 Interv. CQ Par :
aPTT 09:15 Intervalle dfaut Intervalle person. 29.05.2015 Interv. CQ 09:15 Af cher valeur cible On Off Dviation de la valeur cible 11.5 %
29.05.2015 Si vous avez slectionn Intervalle dfaut, pour enregistrer ce rglage ou effleurez effleurez pour quitter ce menu sans enregistrer les modifications. Si vous avez slectionn Intervalle person., effleurez dants ou effleurez enregistrer les modifications. Le programme retourne automatiquement l'cran prcdent. Si vous avez slectionn Intervalle person., l'cran Intervalle CQ s'affiche et vous prsente les options suivantes :
pour saisir les rglages correspon-
pour quitter ce menu sans Afficher valeur cible (Activ/Dsactiv) Dviation de la valeur cible (valeur pourcentage). Voir page 80. Pour les solutions de contrle, la valeur cible provient toujours des informations stockes sur la puce d'ta-
lonnage. Si vous avez choisi Intervalle person., vous pouvez slectionner une dviation autorise de la valeur cible dans l'intervalle de 0 22,5 % (dans notre illustration, 11,5 %). Remarque : pour le paramtre de test PT, le pourcen-
tage de dviation de la valeur cible est toujours dfini au moyen de valeurs INR. Mme si vous avez activ le temps de Quick exprim en pourcentage dans les rglages, le lecteur calcule toujours la dvia-
tion au moyen des valeurs INR. Cet intervalle est converti en temps de Quick exprim en pourcentage dans un deuxime temps. tant donn qu'il n'y a pas de corrlation linaire entre les valeurs exprimes comme INR et celles exprimes en temps de Quick en pourcen-
tage, le calcul du pourcentage de dviation (11,5 %
dans l'exemple) l'aide de la valeur cible du temps de Quick en pourcentage mne un rsultat qui peut dvier du rsultat calcul par le lecteur au moyen de la valeur cible INR. 81 3 r u e t c e l u d n o i t a r u g i f n o C 82 Interv. CQ 09:15 Af cher valeur cible On Off Dviation de la valeur cible 11.5 %
29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 2 Par :
PT 09:15 29.05.2015 09:15 3.0 INR
(2.6 - 3.2 INR) 16 %Q
(16 - 20 %Q) 29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 2 Par :
PT 09:15 29.05.2015 09:15 3.0 INR
(2.9, 2.6 - 3.2 INR) 16 %Q
(17, 16 - 20 %Q) 29.05.2015 6 7 Effleurez On (la valeur cible s'affichera avec un rsultat de test) ou Off (la valeur cible ne s'affichera pas). Votre slection est dsormais en surbrillance. Utilisez les flches pour dfinir le pourcentage de dviation autoris de la valeur cible. Utilisez les flches sur la gauche pour ajuster le nombre avant la virgule. Utilisez les flches sur la droite pour ajuster les chiffres aprs la virgule. 8 pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran Rglages CQ. L'intervalle person. et la valeur cible (si dfini sur On) apparaissent sur les crans mmoire CQ et Test CQ, une ligne sous le rsultat du test de contrle. Sur l'cran de gauche, Afficher valeur cible est dfini sur Off : seul l'intervalle personnalis s'affiche sous le rsultat du test de contrle. Sur l'cran de droite, Afficher valeur cible est dfini sur On : l'intervalle personnalis ainsi que la valeur cible s'affichent. La valeur cible (ici : 2,9) apparat en face de l'intervalle personnalis. Blocage CQ (contrle qualit) 83 Le Blocage CQ garantit que les tests de contrle qualit optionnels sont rgulirement effectus. Cette fonction est toutefois indpendante de l'utilisateur. Utilisez cette option si vous travaillez sans liste dutilisateurs. Le Blocage CQ est dsactiv par dfaut. Pour la con-
firmation de routine de la fiabilit du systme, il est recommand d'activer cette fonction. Il est galement possible d'activer en parallle les Blocages Util. et les Blocages CQ. Outre le choix des intervalles de temps ou des nombres, vous pouvez, avec le Blocage CQ, choisir de fixer un contrle qualit loccasion dun changement de lot de bandelettes-test
(Nouv. code). Le dclenchement de blocages est dfini une fois et est valide pour tous les paramtres. Les vnements (inter-
valles de temps, nombres) dclenchant les blocages sont compts individuellement pour chaque paramtre. Menu Princ. 09:15 Menu con g. 09:15 Rglages CQ 09:15 Blocages 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Intervalle CQ Blocages Blocage CQ Blocage Util. Numriser matriel CQ Con g. test URG. 29.05.2015 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglages CQ. Dans le menu Rglages CQ, effleurez l'lment Blocages. Dans le menu Blocages, effleurez l'lment Blocage CQ. Slectionnez le dclenchement d'un test de contrle qualit bas sur le lot et/ou l'heure ou le nombre de bandelettes. 3 r u e t c e l u d n o i t a r u g i f n o C 84 Blocage CQ 09:15 Nouv. Code Oui Non Non Quotidien Hebdomadaire Mensuel 29.05.2015 Blocage CQ 09:15 Nouv. Code Oui Non Hebdomadaire Mensuel Nb dheures Nb de bandelettes 29.05.2015 Le lecteur offre les options suivantes :
Nouv. code Oui/Non (le rglage vaut pour chaque changement de lot de bandelettes-test) Les intervalles de temps sont les suivants :
6 7 Non Quotidien Hebdomadaire Mensuel Nb d'heures Nb de bandelettes Effleurez le bouton correspondant l'option de votre choix pour modifier le lot de bandelettes-test. Effleurez et pour afficher l'intervalle de votre choix l'cran. Les intervalles de temps (Quotidien, Hebdomadaire, Men-
suel) commencent respectivement chaque jour, chaque lundi ou chaque premier jour du mois 00:00 (minuit). Blocage CQ 09:15 Nouv. Code Oui Non Hebdomadaire Mensuel Nb dheures Nb de bandelettes Blocage CQ 09:15 Nombre bandelettes (1-999) :
Blocage CQ Nbre Niveaux 09:15 450 1 Niveau 2 Niveaux 29.05.2015 29.05.2015 29.05.2015 8 9 10 11 12 13 pour continuer ou effleurez Effleurez la zone affichant lintervalle dsir. Votre slection est dsormais en surbrillance. Effleurez pour quitter ce menu sans enregistrer les modifications. Si vous avez slectionn Nb d'heures ou Nb de bandelettes, saisissez maintenant le nombre correspondant. Effleurez pour quitter ce menu sans enregistrer les modifications. Pour chaque option (except loption Non), vous devez indiquer combien de niveaux le contrle qualit doit tre effectu. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer pour continuer ou effleurez 85 3 r u e t c e l u d n o i t a r u g i f n o C 86 Blocage Util. Les contrles de qualit liquides optionnels peuvent tre utiliss pour contrler la bonne excution des tests sur le lecteur CoaguChek Pro II. La fonction Blocage Util. contraint un utilisateur dfini dans la liste effectuer rgulirement ces contrles qualits. Menu Princ. 09:15 Menu con g. 09:15 Rglages CQ 09:15 Blocages 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Intervalle CQ Blocages Blocage CQ Blocage Util. Numriser matriel CQ Con g. test URG. 29.05.2015 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglages CQ. Dans le menu Rglages CQ, effleurez l'lment Blocages. Dans le menu Blocages, effleurez l'lment Blocage Util. Si cette touche est dsactive
(grise), aucun utilisateur n'a t dfini, ou l'option ID utilisat. a t dsactive. L'option consistant dfinir un blocage Util. est unique-
ment disponible lorsque des listes d'utilisateurs ont t dfinies dans le SGD. Pour davantage de dtails, repor-
tez-vous la section Manipulation des donnes partir de la page 139. Si vous ne travaillez pas avec un SGD, seul le Blocage CQ est disponible (voir la section Blocage CQ (contrle qualit) , page 83). Blocage Util. 09:15 Blocage Util. 09:15 Non Hebdomadaire Mensuel Trimestriel Semestriel 29.05.2015 Hebdomadaire Mensuel Trimestriel Semestriel Annuel 87 Blocage Util. Nbre Niveaux 09:15 1 Niveau 2 Niveaux 29.05.2015 5 29.05.2015 Slectionnez la frquence laquelle le contrle qualit obligatoire doit tre effectu. Le lecteur offre les options suivantes :
6 7 8 9 10 pour afficher l'intervalle de votre Non (dsactiv) Hebdomadaire Mensuel Trimestriel ou Semestriel Annuel Effleurez et choix l'cran. Effleurez la zone affichant lintervalle dsir. Votre slection est dsormais en surbrillance. Effleurez pour quitter ce menu sans enregistrer les modifications. Pour chaque option (except loption Non), vous devez indiquer combien de niveaux le contrle qualit doit tre effectu. Effleurez effleurez les modifications. Le programme retourne auto-
matiquement l'cran prcdent. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer pour continuer ou effleurez 3 r u e t c e l u d n o i t a r u g i f n o C 88 Configuration test URG Les tests de contrle qualit assurent une qualit constante et des mesures prcises. Dans les situations d'urgence, il peut tre toutefois ncessaire d'effectuer un test immdiatement. Pour contourner un blocage actif1, vous pouvez activer les Tests URG (URG = urgent). Vous pouvez dfinir le nombre de tests (neuf maximum) autoriss malgr le blocage. Une fois que le nombre de tests URG autoriss a t atteint, un test de contrle qualit devra tre effectu afin que de nouveaux tests puissent tre raliss. Le rglage par dfaut est de trois tests URG. Les rsultats de tests URG sont toujours accompagns de la mention Test URG lors de leur affichage (voir page 115). Le nombre de tests URG effectus est calcul en fonction des paramtres de test utiliss. Une fois que le nombre maximal de tests URG a t atteint, il est ncessaire d'effectuer un test de contrle avant de pouvoir tester ce paramtre. Les autres paramtres de test n'ayant pas encore atteint cette limite restent disponibles. 1. CQ, utilisateur ou blocage de lot nouveau Menu Princ. 09:15 Menu con g. 09:15 Rglages CQ 09:15 Blocages 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Intervalle CQ Blocages Blocage CQ Blocage Util. Numriser matriel CQ Con g. test URG. 29.05.2015 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 6 7 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglages CQ. Dans le menu Rglages CQ, effleurez l'lment Blocages. Dans le menu Blocages, effleurez l'lment Config. test URG. Effleurez l'lment Activer pour permettre les tests URG ou effleurez Dsactiver pour empcher les tests URG. Votre slection est dsormais en surbrillance. si vous avez activ l'option, effleurez et dfinir le nombre de tests supplmentaires. pour enregistrer ce rglage ou Effleurez effleurez pour quitter ce menu sans enregistrer les modifications. pour Test URG 09:15 Activer Dsactiver 3 29.05.2015 89 3 r u e t c e l u d n o i t a r u g i f n o C 90 Numriser matriel CQ Le lecteur de code-barres du lecteur CoaguChek Pro II peut tre utilis pour scanner les codes-barres des flacons de matriel CQ. Menu Princ. 09:15 Menu con g. 09:15 Rglages CQ 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Intervalle CQ Blocages Numriser matriel CQ 29.05.2015 29.05.2015 29.05.2015 1 2 3 4 5 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Rglages CQ. Dans le menu Rglages CQ, effleurez l'lment Numriser matriel CQ. Effleurez Option pour permettre la slection manuelle d'un numro de lot de CQ partir d'une liste ou effleurez Lecture seulement pour empcher la slection manuelle. Votre slection est dsormais en surbrillance. Effleurez effleurez les modifications. pour enregistrer ce rglage ou pour quitter ce menu sans enregistrer Num. mat. CQ. 09:15 Option Lecture seulement 29.05.2015 3.6 Diagnostics Dans Diagnostics, vous trouverez des informations sur le systme, telles que la version logicielle, le nombre d'enre-
gistrements de donnes et les dtails de configuration. Les crans de diagnostic illustrs ci-aprs sont fournis titre d'exemple uniquement. Les informations prsentes sur votre lecteur peuvent tre diffrentes. Menu Princ. 09:15 Menu con g. 09:15 Diagnostics 09:15 Test Patient Test de CQ Examen rsultats Rglages cran Options Rglage ID Rglages CQ Diagnostics Gnral Logiciel Matriel Mmoire occupe Rglages sans l 29.05.2015 29.05.2015 29.05.2015 1 2 3 Dans le Menu Princ., effleurez l'lment Rglages pour ouvrir les paramtres du lecteur. Dans le Menu config., effleurez l'lment Diagnostics. Dans le menu Diagnostics, effleurez le bouton de l'cran de diagnostic que vous souhaitez dfinir. 91 3 r u e t c e l u d n o i t a r u g i f n o C 92 Gnral Nom du lecteur :
CoaguChek Pro II Service dorigine :
Mannheim Dernire synchronisation :
28.05.2015 Rsultats non-transmis :
21 Proch. test CQ programm :
30.05.2015 00:00 09:15 Logiciel 09:15 Matriel 09:15 Mmoire occupe 09:15 Build :
Boot :
Kernel :
Rootfs :
App :
MM-BL :
MM-FW :
04.00.00 00.16.31 00.21.30 00.16.01 04.00.00 0.80 5.00 Numro de srie :
HBM HW :
MM HW :
U76001234 3.53a 03 Tests Pat. :
utiliss/max. (nb) :
Tests de CQ :
utiliss/max. (nb) :
Patient List:
utiliss/max. (nb) :
Liste doprateurs :
utiliss/max. (nb) :
1300/2000 350/500 2700/4000 1250/5000 Tests jq n de vie :
11455 29.05.2015 29.05.2015 29.05.2015 29.05.2015 Rglages sans l 09:15 Rglages sans l 09:15 Rglages sans l - Rseau Rglages sans l - Connexion Utiliser DHCP :
Utiliser DNS :
SSID :
WLAN :
MAC :
Activ Dsactiv SSID123456 1A 3E B6 78 9C AF Nom DMS :
Numro de port DMS :
Adresse IP DMS :
Scurit RF :
POCT Server 4711 192.168.3.21 WPA2-PSK (AES) 09:15 Test Rglages sans l Rglages sans l - Test RF activ :
Associ :
Authenti :
IP reu :
IP :
Sous-rs. :
Passerelle :
DNS :
DMS contact :
Connect au DMS :
Complt :
192.168.3.21 255.255.255.0 29.05.2015 29.05.2015 29.05.2015 4 5 et pour passer d'un cran Rglages Utilisez sans fil l'autre. Dans un des crans de diagnostic, effleurez pour revenir au menu Diagnostics. 4 Mesure d'un chantillon de sang 4.1 Remarques importantes Matriel ncessaire :
Lecteur CoaguChek Pro II Bandelettes-test CoaguChek PT et/ou aPTT avec puce d'talonnage correspondante Lors des tests avec le sang veineux :
Dispositif standard de prlvement de sang
(seringue) Lors des tests avec le sang capillaire :
Autopiqueur approuv pour une utilisation en milieu professionnel (par ex. l'autopiqueur Accu-Chek Safe T-Pro Plus ou les lancettes CoaguChek) Tubes capillaires/bulbes CoaguChek (en option) N'utilisez pas de tubes capillaires en verre ou de tubes capillaires contenant des anticoagulants. Coton et compresses imprgnes d'alcool Toujours refermer le tube de bandelettes aprs avoir retir une bandelette-test. utiliser le lecteur une temprature ambiante comprise entre 12 C et 32 C (54 F et 90 F). placer le lecteur sur une surface plane stable
(table) ou le tenir lhorizontale. se conformer aux consignes relatives lutilisation correcte des bandelettes-test indiques dans la notice demballage. maintenir la glissire dinsertion des bandelettes-
test et le botier du lecteur en parfait tat de pro-
pret. Voir galement le chapitre Maintenance et entretien ( partir de la page 147). 93 4 g n a s e d n o l l i t n a h c n u d
'
e r u s e M 94 Protection contre les infections :
Les chantillons doivent toujours tre obtenus confor-
mment aux mesures de prcaution et aux directives gnrales relatives aux prlvements sanguins (voir page 17). liminez toutes les bandelettes-test ayant servi une mesure sur un patient en vous conformant la rglemen-
tation en vigueur dans votre laboratoire ou votre cabinet mdical (voir page 17). Ne jamais conserver le lecteur des tempratures leves
(suprieures 35 C ou 95 F) dans le cadre d'une utilisation normale. conserver le lecteur non protg dans une atmosphre chaude et humide. retirer ou insrer la puce d'talonnage alors que le lecteur effectue une mesure. toucher ou retirer la bandelette-test au cours d'une mesure. attendre plus de 15 secondes aprs avoir piqu le doigt pour appliquer le sang prlev. piquer le doigt d'un patient dont les mains sont mouilles (rsidus d'eau, de sueur ou d'alcool). rajouter du sang une fois que la mesure a commenc. effectuer une mesure avec une goutte de sang provenant d'une ponction prcdente. ATTENTION Exactitude/prcision des rsultats mesurs :
Le non-respect de ces rgles peut tre lorigine de rsultats errons. Un rsultat incorrect peut entraner une erreur de diagnostic, mettant ainsi la vie du patient en danger. Recommandations concernant le prlvement de sang capillaire 95 Prparez le site de prlvement de sang slectionn et prlevez du sang sur le patient conformment aux procdures de votre tablissement. S'il n'existe pas de procdures pour votre tablissement, suivez les recommandations suivantes pour prlever du sang capillaire :
Rchauffez la main. Pour ce faire, conseillez au patient de la maintenir sous son bras ou utilisez un rchauffe-mains. Lavez-lui les mains au savon et l'eau chaude et dsinfectez le site de prlvement de sang. Schez-les soigneusement. Laissez pendre le bras sur le ct du patient avant de piquer un doigt. Massez le doigt depuis sa base. Utilisez ces techniques jusqu' ce que le bout du doigt soit plus color. Immdiatement aprs la ponction, massez le ct du doigt pour faire sortir une goutte de sang de taille suffisante, sans exercer de pression ou crasement. Appliquez la goutte de sang directement sur la bandelette-test, dans les 15 secondes suivant la ponction. Vous pouvez galement utiliser un tube capillaire CoaguChek pour recueillir l'chantillon de sang. ATTENTION Aprs avoir nettoy et dsinfect le doigt du patient, laissez-le scher entirement. Des rsidus d'eau ou de dsinfectant sur la peau peuvent diluer la goutte de sang et produire ainsi des rsultats errons. 4 g n a s e d n o l l i t n a h c n u d
'
e r u s e M 96 Recommandations concernant la dtermination sur sang veineux total Utilisez un dispositif de prlvement de sang standard pour le prlvement dchantillon. Le sang ne doit pas tre recueilli dans des tubes de prlvement contenant des anticoagulants (EDTA, citrate, fluorure, oxalate ou hparine, par ex.). Les chantillons de sang veineux peuvent tre prlevs sur un cathter. Si les chantillons veineux sont prlevs par ponction veineuse, notez les points suivants :
Utilisez une aiguille de la taille 23 G (env. 0,65 mm) ou plus grosse. Rejetez les quatre premires gouttes de sang recueillies (au cours des 10 premires secondes), puis appliquez immdiatement une goutte de sang
(au moins 8 L) directement sur la zone de la bandelette-test prvue cet effet. Assurez-vous que l'chantillon ne contient aucune bulle d'air. Protection contre les infections :
Les chantillons doivent toujours tre obtenus confor-
mment aux mesures de prcaution et aux directives gnrales relatives aux prlvements sanguins (voir page 17). liminez toutes les bandelettes-test ayant servi une mesure sur un patient en vous conformant la rglemen-
tation en vigueur dans votre laboratoire ou votre cabinet mdical (voir page 17). 4.2 Prparation Puce d'talonnage des bandelettes-test 1 2 Prparez le tube de bandelettes-test. Prparez la puce dtalonnage et assurez-vous que le code correspond bien ces bandelettes-test. Chaque bote de bandelettes-test (PT ou aPTT) contient une puce d'talonnage. Le paramtre et le numro de la puce d'talonnage doivent correspondre au numro du tube de bandelettes-test. Un S majuscule devant le numro indique que la puce d'talonnage correspond aux bandelettes-test. (Un C majuscule devant le numro indique qu'il s'agit de la puce d'une solution de contrle. Voir chapitre 5, Test de contrle et de comptence). La puce d'talonnage fournit au lecteur les informations indispensables la ralisation de la mesure de la coagulation. La puce contient des informations relatives la mthode de test, au numro de lot et la date de premption. La puce d'talonnage est ncessaire ds qu'un nouveau lot de bandelettes-test est utilis afin que le lecteur puisse lire et enregistrer les informations spcifiques ce lot donn. Votre lecteur CoaguChek Pro II peut enregistrer en mmoire les donnes de 60 puces dtalonnage de bandelettes-test qui ont t insres. N'oubliez pas d'utiliser la puce d'talonnage fournie avec chaque bote de bandelettes-test avant d'effectuer la premire mesure avec ces bande-
lettes. Nous recommandons de laisser la puce dtalonnage dans lappareil, pour prserver les contacts lectriques de salets. Chaque puce dtalonnage est spcifique un lot de bandelettes-test. Ne retirez la puce d'talonnage que lorsque vous effectuez des mesures l'aide de bandelettes-test issues dune bote neuve. Protgez la puce d'talonnage de l'humidit et des appareils gnrant des champs magntiques. 97 4 g n a s e d n o l l i t n a h c n u d
'
e r u s e M 98 Insertion de la puce dtalonnage 1 Retirez le cas chant l'ancienne puce dtalon-
nage se trouvant dans le lecteur. 2 3 Assurez-vous que les chiffres du code de la puce d'talonnage concident avec ceux du code figurant sur l'tiquette du tube des bandelettes-test. Introduisez ensuite la nouvelle puce d'talonnage dans la fente d'insertion (comme illustr) en pous-
sant jusqu' ce que vous entendiez un dclic. Si la puce d'talonnage est absente ou qu'elle n'est pas insre correctement, un message d'erreur s'affiche l'cran (reportez-vous la section Dpannage de ce manuel). Mise sous tension du lecteur 1 2 Placez le lecteur sur une surface plane et exempte de vibrations ou tenez-le l'horizontale. Allumez le lecteur en appuyant sur Vous pouvez galement allumer le lecteur en insrant une bandelette-test ou en connectant l'adaptateur. Les tapes suivantes dpendent du travail avec la fonction ID utilisateur active ou dsactive (voir Manipulation des donnes en page 139). Menu Princ. 09:15 3 Attendez que le Menu principal saffiche. Si la fonction ID utilisateur est dsactive :
Test Patient Test de CQ Examen rsultats Rglages 29.05.2015 99 4 g n a s e d n o l l i t n a h c n u d
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e r u s e M 100
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A F K P U Z ID utilisat. 09:15 E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan Si la fonction ID utilisateur est active :
Sans liste dutilisateurs :
3 Vous tes invit saisir un ID utilisateur1. Saisissez l'ID utilisateur l'aide du clavier. Appuyez sur pour passer l'cran suivant. L'ID utilisateur peut galement tre saisi via le lecteur de code-barres intgr2. Effleurez Scan et scannez le code-barres de l'utilisateur une distance d'environ 10 20 cm (4 8 pouces), selon la taille du code-barres. Le lecteur met un bip lorsque le code-barres est lu. Les informations du code-barres apparaissent dans le champ ID utilisa-
teur. Le lecteur steint au bout de 10 secondes si aucun code-barres nest lu. 1. 2. Pour plus d'informations sur la configuration des identifiants utilisateur et patient, voir page 145. Une liste des symbologies de codes-barres prises en charge est disponible l'annexe A.2, page 166, et une liste des caractres pris en charge l'annexe A.3, page 169. Utilisateur 09:15 Alan Smithee Jane Brown Ann Casey Joe Dalton Scan 29.05.2015 Mot De Passe 09:15
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0 5 1 6 2 7 3 8 4 9 ABC Menu Princ. 09:15 Test Patient Test de CQ Examen rsultats Rglages Quitter 29.05.2015 Avec liste dutilisateurs :
3 4 Attendez que la liste d'utilisateurs saffiche. Slectionnez l'utilisateur de votre choix en effleu-
rant le bouton correspondant ou effleurez Scan pour scanner le code-barres d'un utilisateur. Remarque : les ID utilisateur scanns doivent gale-
ment se trouver dans la liste. Dans le cas contraire, la tentative de connexion choue et un message d'erreur s'affiche. 5 6 7 Saisissez votre mot de passe (facultatif). Une fois le mot de passe saisi, effleurez vous connecter. Le Menu principal saffiche et vous pouvez commencer la mesure. En effleurant nouveau.
, la liste d'utilisateurs s'affiche pour Si vous avez termin la mesure ou si un autre utilisateur doit effectuer des mesures supplmentaires, vous pouvez quitter cet cran en effleurant la zone Quitter (disponible uniquement si l'option ID utilisateur est active). Le lec-
teur revient la liste des diffrents utilisateurs. Remarque : la fonctionnalit tendue de manipulation des donnes et les options de connexion de l'utilisateur dpendent des capacits du systme de gestion des donnes (SGD) utilis. Pour davantage de dtails, reportez-vous la section Manipulation des donnes partir de la page 139. 101 4 g n a s e d n o l l i t n a h c n u d
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e r u s e M 102 4.3 Excution d'une mesure Menu Princ. 09:15 1 Vrifiez ltat des piles. Test Patient Test de CQ Examen rsultats Rglages 29.05.2015 Menu Princ. 09:15 Blocage CQ Test de CQ Examen rsultats Rglages Quitter 29.05.2015 Menu Princ. 09:15 CQ!
Test Patient Test 09:15 Statut de CQ PT aPTT
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3 Bloqu Test de CQ Examen rsultats Rglages Quitter 29.05.2015 29.05.2015 Si le symbole de la pile passe au rouge (une seule barre), il se peut que l'alimentation soit insuffisante pour la ralisation d'un autre test. Si le symbole de la pile ne contient plus aucun seg-
ment, il ne sera pas possible deffectuer une mesure de contrle qualit. teignez le lecteur en appuyant sur
. Dans les deux cas, rechargez le bloc-piles ou utilisez l'adaptateur pour assurer l'alimentation du lecteur. 2 Vrifiez que la date et lheure sont correctes. Corrigez toute erreur au niveau des rglages comme indiqu dans le chapitre 3, Configuration du lecteur/ Rglage de la date . Si une touche de blocage (Blocage Util. ou Blocage CQ) s'affiche la place de la touche Test Patient, vous devez effectuer un test de contrle qualit liquide avant d'effectuer une mesure patient (veuillez vous rfrer au chapitre 5, Test de contrle et de comptence. Lorsque le lecteur est en mode blocage, aucun test patient ne peut tre effectu. Les tapes suivantes dpendent de l'utilisation ou non de listes de patients. Si le bouton Test Patient est disponible mais qu'un blocage est affich (QC!), un ou plusieurs paramtres de test sont bloqus. Un test ne peut tre effectu que pour les paramtres qui ne sont pas encore bloqus ou en tant que test URG (si cette fonction est active et qu'il reste assez de tests URG disponibles). Dans ce cas, un cran d'tat de CQ s'affiche aprs que vous avez effleur Test Patient. Pour plus de dtails sur la configuration des tests URG, voir les pages 88 et 115. Sans liste de patients 3 4 Effleurez Test Patient. Si l'option ID patient a t dtermine comme optionnelle ou requise lors du paramtrage du lecteur (voir Configuration du lecteur / ID patient ), vous tes invit saisir un ID patient1. Si ce choix est requis, saisissez l'ID patient puis effleurez Si ce choix est optionnel, ignorez la demande et effleurez pour passer l'cran suivant. Le lecteur numrotera la mesure selon un ordre conscutif. Si aucune option n'a t choisie, un cran apparat pour vous inviter introduire une bandelette-test. Poursuivez avec l'tape 9. pour passer l'cran suivant.
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A F K P U Z ID patient 09:15 E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan 103 4 g n a s e d n o l l i t n a h c n u d
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1. Pour plus d'informations sur la configuration des identifiants utilisateur et patient, voir page 145. e r u s e M 104 Avec liste de patients Test 09:15 PID01 Smith, Henry PID02 Jones, Walther PID03 Hamilton, Fran PID04 Miller, Ted PID05 Reed, William Nouv. Scan 29.05.2015
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A F K P U Z ID patient 09:15 E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan 5 6 7 et pour afficher la saisie de votre Effleurez Test Patient. Effleurez choix. Slectionnez le patient pour lequel des mesures doivent tre effectues partir de la liste. Si le patient napparat pas dans la liste, vous pouvez linscrire dans la liste en effleurant la zone Nouv. pour crer une nouvelle entre. Vous devez dsormais saisir un ID patient l'aide du clavier. Remarque : la fonctionnalit tendue de manipulation des donnes et les options de saisie d'ID patient dpen-
dent des capacits du systme de gestion des donnes
(SGD) utilis. Pour davantage de dtails, reportez-vous la section Manipulation des donnes partir de la page 139. L'ID patient peut galement tre saisi via le lecteur de code-barres intgr1. Effleurez Scan et scannez le code-barres du patient une distance d'environ 10 20 cm (4 8 pouces), selon la taille du code-barres. Le lecteur met un bip lorsque le code-barres est lu. Les informations du code-barres apparaissent dans le champ ID patient. Le lecteur steint au bout de 10 secondes si aucun code-barres nest lu. 105 4 g n a s e d n o l l i t n a h c n u d
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1. Une liste des symbologies de codes-barres prises en charge est disponible l'annexe A.2, page 166, et une liste des caractres pris en charge l'annexe A.3, page 169. e r u s e M 106 Test 09:15 PT aPTT Test ID P : PID01 Mller, David Schulz PT Util :
Par :
29.05.2015 Si l'option Slection paramtres est active dans les paramtres du lecteur, vous tes invit slectionner le paramtre tester. La procdure de test est similaire pour les deux para-
mtres. Le test avec des bandelettes-test PT est pris comme exemple des fins d'illustration. 09:15 29.05.2015 8 9 Slectionnez le paramtre de votre choix en effleurant la zone correspondante. Le symbole de la bandelette-test vous invite ins-
rer une bandelette-test. Retirez la bandelette-test du tube puis rebouchez-le. Les conditions ambiantes (humidit par exemple) peuvent provoquer la dtrioration des bandelettes-
test et entraner alors l'affichage de messages d'erreur. De ce fait, refermez toujours le tube de bandelettes aprs avoir retir une bandelette-test. 10 11 Tenez la bandelette de sorte que le nom du test soit orient vers le haut. Introduisez la bandelette-test dans la glissire dinsertion du lecteur dans le sens des flches. Poussez la bandelette-test jusqu la bute. Un bip indique la dtection de la bandelette-test
(si l'avertisseur sonore est activ). Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT 184 29.05.2015 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 3:00 Min. 29.05.2015 09:15 09:15 09:15 Si vous utilisez un nouveau lot de bandelettes-test et navez pas encore insr la puce dtalonnage, vous avez ici encore la possibilit de le faire. Sans la puce dtalon-
nage correspondante, il vous sera impossible dexcuter une mesure. Le lecteur affiche le numro de la puce d'talonnage correspondant au nouveau lot de bande-
lettes-test. Selon les options de rglage que vous avez choisies, il peut tre galement ncessaire deffectuer un contrle qualit liquide. Le symbole du sablier indique que la bandelette-test est prchauffe. Lorsque la bandelette-test est prte (et dans la mesure o l'avertisseur sonore a t pralablement activ), un deuxime signal sonore vous informe que vous pouvez appliquer le sang. Le symbole de la goutte de sang clignote pour indiquer que le lecteur est prt effectuer la mesure et attend le dpt du sang. Un compte rebours commence. Vous devez appliquer la goutte de sang sur la bandelette-test avant la fin de ce dcompte. Sinon, vous recevrez un message d'erreur. Lors de l'excution du test, aucune action de l'utilisateur n'est ncessaire. L'cran s'assombrit de manire conomiser l'nergie. 107 4 g n a s e d n o l l i t n a h c n u d
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e r u s e M 108 Dpt de sang depuis la pulpe du doigt AVERTISSEMENT Utilisez uniquement un autopiqueur approuv pour une utilisation par des professionnels de la sant, comme l'autopiqueur Accu-Chek Safe-T-Pro ou Safe-T-Pro Plus, ou encore les lancettes CoaguChek (lancettes usage professionnel disponibles uniquement aux tats-Unis). Suivez les instructions du fabricant. 12 Piquez la pulpe du doigt sur le ct l'aide de l'autopiqueur. Nous vous conseillons de prlever le sang capillaire en piquant le ct de la pulpe du doigt, l o la ponction est la moins douloureuse. Massez doucement le doigt piqu jusqu' la formation d'une goutte de sang. Ne comprimez pas et n'crasez pas le doigt. Dposez la premire goutte de sang prleve au doigt. 13 Appliquez le sang directement du doigt sur la zone de dpt transparente semi-circulaire de la bandelette-test. Vous pouvez aussi faire pntrer la goutte de sang sur le ct de la zone de dpt (au lieu de la dpo-
ser au milieu de cette zone). La bandelette-test absorbe le sang par capillarit. Si vous choisissez cette mthode, laissez la goutte de sang en contact avec la bandelette-test jusqu ce que le symbole clignotant de la goutte de sang ait disparu et que le lecteur ait mis un signal sonore (sil est activ). Vous pouvez aussi dposer le sang laide dun tube capillaire optionnel CoaguChek. Dposez ou appliquez la goutte de sang sur la bande-
lette-test dans un dlai de 15 secondes aprs piqre du doigt. Toute application du sang aprs cette priode peut entraner des rsultats errons puisque le processus de coagulation aura dj commenc. Si la goutte est dpose sur le dessus de la bandelette, le sang doit entirement recouvrir la zone de dpt. Dpt de sang l'aide d'une seringue 109 4 g n a s e d Rejetez les quatre premires gouttes de sang recueillies (au cours des 10 premires secondes), puis appliquez immdiatement une goutte de sang (au moins 8 L, mais pas plus de 20 L) directement sur la zone de la bandelette-test prvue cet effet. Assurez-vous que l'chantillon ne contient aucune bulle d'air. En cas de dpt excessif de sang (> 20 L), l'extrieur du lecteur et la glissire dinsertion des bandelettes-test doivent tre nettoys et dsinfects. Pour de plus amples informations sur le prlvement d'chantillons, voir page 96. n o l l i t n a h c n u d
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e r u s e M 110 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 09:15 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 CQ Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 09:14 2.5INR 21%Q Test ID P : PID01 29.05.2015 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 29.05.2015 09:14 INR
> 8.0 29.05.2015 09:15 Le lecteur met un signal sonore pour avertir que la quantit de sang dpose est suffisante (sous rserve de l'activation pralable de l'avertisseur sonore). Le symbole de la goutte de sang disparat et la mesure commence. Ne rajoutez pas de sang. Afin d'viter des messages d'erreur, ne touchez pas la bandelette-test avant que le rsultat saffiche. Avant dafficher le rsultat, le lecteur procde un contrle qualit automatique. Celui-ci est symbolis par laffichage des lettres CQ (Contrle Qualit). 09:15 Si le rsultat du contrle qualit est satisfaisant, une coche apparat en regard de CQ . Le rsultat est exprim dans lunit slectionne lors du paramtrage du lecteur. Il est enregistr automatique-
ment. 09:15 Pour obtenir des informations sur les intervalles de mesure valides des bandelettes-test CoaguChek PT et des bandelettes-test CoaguChek aPTT, consultez leurs notices d'emballage respectives. Les rsultats situs au-dessus ou au-dessous de l'inter-
valle de mesure sont indiqus par les symboles > (au-
dessus) ou < (au-dessous). 09:15 Test ID P : PID05 Util :
Par :
Mller, David Schulz PT 29.05.2015 09:14 Code : 208 1.6INR C 09:15 29.05.2015 Test ID P : PID05 Util :
Par :
Mller, David Schulz PT 29.05.2015 09:14 Code : 208 1.6INR C 29.05.2015 Si un C s'affiche ct du rsultat :
Cela peut se produire si le taux d'hmatocrites est trs bas ou en raison d'un mauvais prlvement de sang (par ex., mains humides). Effectuez une nouvelle mesure. Si du sang capillaire est utilis, veillez ce que les mains du patient soient sches. Si le message persiste, vrifiez le taux d'hmatocrites. Cela peut se produire si le rsultat de test est en dehors Si * s'affiche ct du rsultat :
de l'intervalle normal. Effleurez le symbole * pour afficher l'cran d'information Hors intervalle normal. Pour interprter les rsultats, veuillez vous rfrer aux informations relatives aux limites et aux interfrences dtailles dans la section Limites de la notice d'emballage des bandelettes-test. 111 4 g n a s e d n o l l i t n a h c n u d
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e r u s e M 112 Validation ou refus d'un rsultat de test Si cette fonction est active, vous pouvez choisir de valider ou de refuser un rsultat de test. Une fois le rsultat affich, effleurez Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 09:15 Refuser ou Valider Si vous refusez un rsultat, vous devez saisir un commentaire d'explication. Si vous refusez le rsultat, celui-ci ne s'affichera plus. L'entre du test sera toutefois enregistre. 09:15 29.05.2015 09:14 2.5INR 21%Q Rsultat mesure OK ?
Refuser Valider 29.05.2015 Commentaire requis I-009 Un commentaire est requis si vous refusez un rsultat. Veuil-
lez saisir un commentaire. Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 09:14 Refus Devra refaire test 29.05.2015 Ajout de commentaires 09:15 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 09:14 2.5INR 21%Q 29.05.2015 Commentaire 09:15 Asymptomatique Lecteur nettoy Mdecin inform Malade Personnal. 29.05.2015 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 09:14 2.5INR 21%Q Mdecin inform Malade En voyage 29.05.2015 113 Vous pouvez ajouter jusqu trois commentaires par rsultat de mesure. Les commentaires peuvent contenir, par exemple, des informations additionnelles sur les conditions de test ou le patient. Un commentaire peut comporter jusqu' 20 caractres. Vous pouvez appeler la fonction dajout de commentaires directement partir de lcran des rsultats. Pour ajouter des commentaires :
Si vous souhaitez ajouter un commentaire, ne retirez pas la bandelette-test. Une fois qu'elle est retire, le lec-
teur revient automatiquement au Menu principal et il n'est plus possible d'ajouter de commentaire. 1 2 3 4
. Dans lcran Test, effleurez Slectionnez le commentaire prdfini dsir partir de la liste (si configur) ou Effleurez la touche Personnal. pour saisir votre propre commentaire personnalis. Utilisez le clavier
(comme pour louverture de session) pour ajouter votre commentaire. Une fois le ou les commentaires dsirs slection-
ns, effleurez pour revenir lcran des rsultats. 09:15 l'icne d'imprimante n'apparat que si la fonction imprimante est active. Dans le cas contraire, elle ne s'affiche pas. Les rsultats des tests sont galement sauvegards dans lcran des rsultats lorsque le lecteur est teint ou lorsquil steint automatiquement. 4 g n a s e d n o l l i t n a h c n u d
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e r u s e M 114 Affichage du rsultat de test sous forme de code QR L'icne de code QR n'apparat que si la fonction d'affichage du code QR est active (voir page 64 et sui-
vantes). Dans le cas contraire, elle ne s'affiche pas. Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 11:31 2.5INR 21%Q Mdecin inform Malade NOUVEAU MDICAMENT 29.05.2015 09:15 Test 09:15 1 2 Effleurez de code QR. Effleurez des rsultats. pour afficher le rsultat sous forme pour revenir l'affichage standard La taille du code QR affich l'cran varie selon la quantit de donnes encodes. 29.05.2015 Fin du test Retirer 09:15 29.05.2015 Une fois le rsultat affich, effleurez invit retirer la bandelette. Vous serez 1 2 3 Retirez la bandelette-test du lecteur. Mettez le lecteur hors tension. Nettoyez-le si ncessaire (voir chapitre 8, Maintenance et entretien). Protection contre les infections :
Les chantillons doivent toujours tre obtenus confor-
mment aux mesures de prcaution et aux directives gnrales relatives aux prlvements sanguins (voir page 17). liminez toutes les bandelettes-test ayant servi une mesure sur un patient en vous conformant la rglemen-
tation en vigueur dans votre laboratoire ou votre cabinet mdical (voir page 17). Tests URG Les tests URG constituent un nombre limit de tests qui peuvent tre effectus en cas d'urgence (voir page 88). Si le lecteur est configur pour effectuer des tests URG, vous pouvez choisir d'effectuer un test URG mme si un blocage CQ est en place. Menu Princ. 09:15 Test 09:15 Test 09:15 CQ!
Test Patient Test de CQ Examen rsultats Rglages Quitter Statut de CQ PT aPTT
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3 Bloqu PT aPTT Info URG I-011 3 tests URG restant avant blocage. 29.05.2015 29.05.2015 29.05.2015 Test ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 184 29.05.2015 09:14 2.5INR 21%Q Test URG 29.05.2015 09:15 1 2 3 4 Afin d'effectuer la mesure sans raliser un test de contrle qualit, effleurez Test patient :
Slectionnez le paramtre de votre choix en effleurant la zone correspondante. Effleurez URG restants. Effectuez le test. pour confirmer le nombre de tests Lorsqu'un test URG est effectu, les informations sont enregistres avec le rsultat. Un test URG de moins est autoris. Une fois que tous les tests de contrle qualit en attente ont t raliss, le nombre de teste URG spcifi est nouveau disponible en cas de nouveau blocage. Le paramtre par dfaut est de trois pour le nombre de tests URG autoriss en cas de blocage CQ. 115 4 g n a s e d n o l l i t n a h c n u d
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e r u s e M 116 Cette page est intentionnellement laisse blanche. 5 Test de contrle et de comptence 5.1 Test de CQ 117 Le lecteur CoaguChek Pro II dispose d'une srie de fonc-
tionnalits intgres ddies au contrle de qualit :
Vrification des composantes et des fonctions lectroniques la mise sous tension du lecteur. Vrification de la temprature de la bandelette-test au cours de la mesure. Vrification de la date de premption et des informations relatives au lot figurant sur la bandelette-test. Contrle qualit intgr de chaque bandelette-test. Roche Diagnostics propose des contrles de qualit liquides pour le systme CoaguChek Pro II. Ces contrles sont conus pour assurer la conformit la rglementa-
tion en vigueur dans votre tablissement. Pour effectuer un test de contrle qualit en utilisant les solutions de contrle, vous avez besoin des lments suivants :
Lecteur CoaguChek Pro II La puce d'talonnage des bandelettes-test fournie avec le tube de bandelettes-test que vous utilisez
(une puce d'talonnage est fournie avec chaque bote de bandelettes-test). Bandelettes-test fournies avec la puce d'talon-
nage mentionne ci-dessus Flacons de contrles CoaguChek PT, contrles CoaguChek aPTT, pipettes compte-gouttes de diluant et puce d'talonnage du contrle qualit fournie. Vous pouvez dterminer la frquence des tests de contrle qualit liquide au cours du paramtrage du lec-
teur. (Veuillez vous reporter au chapitre Configuration du lecteur / Blocage CQ (contrle qualit) partir de la page 83). Si les rsultats de contrle affichs sont compris dans l'intervalle spcifi, le test de contrle liquide a t effectu correctement. 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 118 5.2 Prparation pour effectuer un test de contrle qualit liquide Prparez un test de contrle qualit liquide de la mme faon que pour prparer un test avec un chantillon de sang capillaire. La seule diffrence rside dans l'utilisa-
tion d'une solution de contrle la place du sang. 1 Prparez le tube de bandelettes-test. 2 Si vous utilisez un lot de bandelettes-test pour la premire fois, veillez prparer la puce dtalonnage correspondante. 3 Prparez le flacon contenant le plasma de contrle lyophilis et la pipette compte-gouttes pour la reconstitution de la solution de contrle. Ce flacon doit rester rfrigr (pas congel) jusqu' son utilisation. 4 Veillez avoir la puce dtalonnage du contrle qualit correspondant la solution de contrle porte de main. 5 Ouvrez le couvercle du flacon et tez le bouchon en caoutchouc. 6 Tenez la pipette compte-gouttes vers le haut et coupez le bout scell avec des ciseaux. Maintenez la pipette compte-gouttes suffisamment loin de votre visage. Pour viter toute perte de diluant, tenez la pipette compte-gouttes par la tige ; ne pressez pas le bulbe de la pipette en dcoupant le bout. 7 8 9 Vider le contenu intgral de la pipette compte-
gouttes dans le flacon en exerant une lgre pres-
sion sur le rservoir. Veillez ce que la pipette compte-gouttes nentre pas en contact avec le plasma de contrle lyophilis. Refermez le flacon. Tenez la pipette compte-gouttes porte de main pour la suite du contrle qualit liquide. 10 Mlangez le plasma de contrle dans le flacon par un mouvement de rotation jusqu dissolution com-
plte. Ne secouez pas le flacon, ne le renversez pas sur le ct. Les composants du plasma du contrle pourraient adhrer aux parois du flacon. Veuillez consulter la notice d'emballage de la solution de contrle. La solution de contrle est maintenant prte tre dpose sur la bandelette-test. Les solutions de contrle peuvent tre reconstitues
(mlanges) une fois qu'elles ont t retires du rfrig-
rateur. Pour de plus amples informations, consultez les notices d'emballage respectives. 119 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 120 5.3 Excution du contrle qualit liquide 1 Placez le lecteur sur une surface plane et exempte de vibrations ou tenez-le l'horizontale. Allumez le lecteur en appuyant sur 2 Vous pouvez galement allumer le lecteur en insrant une bandelette-test ou en connectant l'adaptateur. 3 4 Attendez que le Menu principal saffiche ou effec-
tuez si ncessaire lenregistrement de lutilisateur dcrit la page 100. Vrifiez ltat des piles. Si le symbole de la pile passe au rouge (une seule barre), il se peut que l'alimentation soit insuffisante pour la ralisation d'un autre test. Si le symbole de la pile ne contient plus aucun seg-
ment, il ne sera pas possible deffectuer une mesure de contrle qualit. teignez le lecteur en appuyant sur
. Dans les deux cas, rechargez le bloc-piles ou utilisez l'adaptateur pour assurer l'alimentation du lecteur. 5 Vrifiez que la date et lheure sont correctes. Corrigez toute erreur au niveau des rglages comme indiqu dans le chapitre 3, Configuration du lecteur/ Rglage de la date . Menu Princ. 09:15 Test Patient Test de CQ Examen rsultats Rglages 29.05.2015 Menu Princ. 09:15 Test CQ 09:15 Test CQ 09:15 Test CQ 09:15 Test Patient Test de CQ Test de CQ Test comptence Examen rsultats Rglages PT aPTT Util :
Schulz Par :
PT 29.05.2015 29.05.2015 29.05.2015 29.05.2015 6 7 8 9 Effleurez Test de CQ. Dans le menu Test CQ, effleurez nouveau Test de CQ. Slectionnez le paramtre de votre choix en effleurant la zone correspondante. Le symbole de la bandelette-test vous invite ins-
rer une bandelette-test. Retirez la bandelette-test du tube puis rebouchez-le. Les conditions ambiantes (humidit par exemple) peu-
vent provoquer la dtrioration des bandelettes-test et entraner alors l'affichage de messages d'erreur. Il faut ainsi veiller refermer le tube immdiatement aprs y avoir extrait une bandelette-test. 11 10 Tenez la bandelette de sorte que le nom du test soit orient vers le haut. Introduisez la bandelette-test dans la glissire dinsertion du lecteur dans le sens des flches. Poussez la bandelette-test jusqu la bute. Un bip indique la dtection de la bandelette-test
(si l'avertisseur sonore est activ). 121 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 122 Test CQ 09:15 Util : Utilisateur 1 184 Test CQ 09:15 Nouv. Code CQ 070 CQ 060 CQ 050 CQ 048 29.05.2015 Scan 29.05.2015 Si vous utilisez un nouveau lot de bandelettes-test et navez pas encore insr la puce dtalonnage, vous avez ici encore la possibilit de le faire. Sans la puce dtalon-
nage correspondante, il vous sera impossible dexcuter un test de contrle qualit. Comme les bandelettes-test, les solutions de contrle possdent leur propre puce dtalonnage. Cette puce renseigne le lecteur sur les intervalles acceptables de rsultats pour le lot de contrles donn. Les informations contenues dans cette puce restent enregistres dans la mmoire afin que vous puissiez utiliser les solutions de contrle tout moment. 12 Slectionnez le code enregistr pour la solution de contrle actuelle ou effleurez la zone Nouv. Code pour utiliser une nouvelle solution de contrle. Lorsque vous saisissez ou slectionnez un code manuel-
lement, assurez-vous qu'il correspond au code imprim sur le flacon de la solution de contrle. La solution de contrle peut galement tre saisie via le lecteur de code-barres intgr. Effleurez Scan et scannez le code-barres sur l'tiquette une distance d'environ 10 cm. Le lecteur met un bip lorsque le code-barres est lu. Les informations du code-barres apparaissent dans le champ de code. Le lecteur steint au bout de 10 secondes si aucun code-barres nest lu. Test CQ 09:15 Code : 184 Util : Utilisateur 1 Par :
PT QC 29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Par :
PT 09:15 Niveau 1 Niveau 2 29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 1 Par :
PT 09:15 29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 1 Par :
PT 09:15 3:00 Min. 29.05.2015 Si vous utilisez une nouvelle solution de contrle, retirez la puce dtalonnage de la bandelette-test du lecteur et insrez celle de la solution de contrle. Si les puces d'talonnage se mlangent, vrifiez la lettre prsente sur les puces pour les diffrencier : Un S majuscule devant le numro indique que la puce d'ta-
lonnage correspond aux bandelettes-test. Un C majus-
cule devant le numro indique qu'il s'agit de la puce d'une solution de contrle. 13 Si vous travaillez avec plus d'un niveau, slection-
nez le niveau correspondant cette mesure. Le symbole du sablier indique que la bandelette-test est prchauffe. Lorsque la bandelette-test est prte (et dans la mesure o l'avertisseur sonore a t pralablement activ), un deuxime signal sonore vous informe que vous pouvez appliquer la solution de contrle. Le symbole de la pipette compte-gouttes clignote pour indiquer que le lecteur est prt effectuer la mesure et attend le dpt de la solution. Simultanment, le lecteur lance un compte rebours. La solution doit tre dpose sur la bandelette-test dans le dlai affich, sinon un message derreur apparat lcran. 123 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 124 14 15 Pipetez maintenant la solution contenue dans le flacon laide de la pipette compte-gouttes. Dposez une seule goutte de solution de contrle directement de la pipette compte-goutte sur la zone de dpt transparente semi-circulaire de la bandelette-test. Ne rajoutez pas de solution de contrle. Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 1 Par :
PT 09:15 29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 1 Par :
PT 09:15 Pass :
29.05.2015 09:15 1.2 INR
(1.0 - 1.4 INR) 78 %Q
(53 - 99 %Q) 29.05.2015 Test CQ CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 1 Par :
PT 09:15 Fail 29.05.2015 09:15 0.9 INR
(1.0 - 1.4 INR) 110 %Q
(53 - 99 %Q) 29.05.2015 Le lecteur met un signal sonore pour avertir que la quantit de solution de contrle dpose est suffisante
(sous rserve de l'activation pralable de l'avertisseur sonore). Le symbole de la pipette compte-goutte disparat et la mesure commence. Le rsultat du contrle qualit liquide s'affiche. Il est enregistr automatiquement dans la mmoire. La plage acceptable de rsultats pour le contrle liquide s'affiche sous le rsultat donn, de mme que l'indication Pass ou Fail. Si le contrle qualit a chou, des flches le signalent en clignotant (valeur trop leve/trop basse). Remarque : la flche (prs du rsultat) ne se rapporte qu'au rsultat INR. Si vous avez choisi d'afficher l'lNR et le temps de Quick exprim en pourcentage (%Q) ou l'INR et le temps de Quick exprim en secondes (Sec), la flche (vers le haut ou vers le bas) situe prs des rsultats se rapportera uniquement la valeur INR. l'icne d'imprimante n'apparat que si la fonction imprimante est active. Dans le cas contraire, elle ne s'affiche pas. Indpendamment des paramtres d'Unit des rsultats choisis pour le PT, l'aPTT s'affiche toujours en secondes
(voir page 50). 125 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 126 Comment. CQ 09:15 Contr. acceptable Lecteur nettoy Mdecin inform Nouv. lot contrle Personnal. 29.05.2015 Retirer 09:15 29.05.2015 16 17 18 19
. Si vous souhaitez ajouter un commentaire, effleurez Slectionnez le commentaire prdfini dsir partir de la liste (si configur) ou Effleurez la touche Personnal. pour saisir votre propre commentaire personnalis. Utilisez le clavier
(comme pour louverture de session) pour ajouter votre commentaire. Un commentaire peut compor-
ter jusqu' 20 caractres. Une fois le ou les commentaires dsirs slection-
ns, effleurez pour revenir lcran des rsultats. Une fois le rsultat affich, effleurez invit retirer la bandelette. Vous serez 20 Retirez la bandelette-test du lecteur. Si vous effectuez un contrle 2 niveaux, vous serez invit passer au second niveau. 21 Mettez le lecteur hors tension. 22 Retirez la puce d'talonnage de contrle qualit et rangez-la avec les contrles. Nettoyez-le si ncessaire (voir chapitre 8, Maintenance et entretien). 23 Jetez les contrles et les bandelettes-test usages conformment la rglementation en vigueur dans votre tablissement. La solution de contrle contient de la matire animale, qui doit tre considr comme tant potentiellement infectieuse. 5.4 Test comptence Observez les rglements et directives applicables des organismes de rglementation responsables lorsque vous effectuez des tests de comptence. Les tests de comptence sont effectus sur les chan-
tillons dont les valeurs sont inconnues l'utilisateur qui effectue le test. Ces chantillons sont fournis par une source externe et les rsultats doivent tre transmis la bonne source une fois le test effectu. Les chantillons fournis sont traits de la mme manire que les chan-
tillons de patient ordinaires. Les tests de comptence fournissent un autre moyen de vrifier que votre mthode, vos ractifs, votre systme et votre test de performances sont appropris. Certains organismes de rglementation exigent que ces chan-
tillons de comptence soient tests dans le cadre d'un programme d'assurance qualit de l'tablissement avant que ce dernier ne puisse tre certifi. Si vous utilisez un systme de gestion des donnes pour la configuration, il est possible de dsactiver enti-
rement ou partiellement les fonctions dcrites dans ce chapitre. Dans ce cas, l'cran de slection correspon-
dant ne s'affiche pas (une fois que vous avez effleur Test de CQ). 127 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 128 5.5 Prparation pour effectuer un test de comptence Prparez un test de comptence de la mme faon que pour prparer un test avec un chantillon de sang capil-
laire. La seule diffrence est que vous utilisez l'chantillon de comptence fourni au lieu du sang d'un patient. Pour effectuer un test de comptence :
Les informations d'au moins une puce d'talonnage pour les bandelettes-test doivent tre enregistres dans le lecteur et correspondre au numro de lot des bandelettes-test utilises. Les bandelettes-test correctes doivent tre disponibles. L'chantillon de comptence doit tre disponible. Si vous utilisez un lot de bandelettes-test pour la pre-
mire fois, assurez-vous que la puce dtalonnage fournie avec ces bandelettes-test est porte de main. 5.6 Ralisation d'un test de comptence 1 Placez le lecteur sur une surface plane et exempte de vibrations ou tenez-le l'horizontale. Allumez le lecteur en appuyant sur 2 Vous pouvez galement allumer le lecteur en insrant une bandelette-test ou en connectant l'adaptateur. 3 4 Attendez que le Menu principal saffiche ou effec-
tuez si ncessaire lenregistrement de lutilisateur dcrit la page 100. Vrifiez ltat des piles. Si le symbole de la pile passe au rouge (une seule barre), il se peut que l'alimentation soit insuffisante pour la ralisation d'un autre test. Si le symbole de la pile ne contient plus aucun seg-
ment, il ne sera pas possible deffectuer une mesure de contrle qualit. teignez le lecteur en appuyant sur
. Dans les deux cas, rechargez le bloc-piles ou utilisez l'adaptateur pour assurer l'alimentation du lecteur. 5 Vrifiez que la date et lheure sont correctes. Corrigez toute erreur au niveau des rglages comme indiqu dans le chapitre 3, Configuration du lecteur/ Rglage de la date . Menu Princ. 09:15 Test Patient Test de CQ Examen rsultats Rglages 29.05.2015 129 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 130 Menu Princ. 09:15 Test CQ 09:15 Comptence 09:15 Test Patient Test de CQ Examen rsultats Rglages Test de CQ Test comptence 29.05.2015 29.05.2015 29.05.2015 Effleurez Test de CQ. Effleurez Test comptence. 6 7 Pour les tests de comptence, les informations de para-
mtres de test sont lues partie de la bandelette-test. 8 Le symbole de la bandelette-test vous invite ins-
rer une bandelette-test. Retirez la bandelette-test du tube puis rebouchez-le. Les conditions ambiantes (humidit par exemple) peu-
vent provoquer la dtrioration des bandelettes-test et entraner alors l'affichage de messages d'erreur. Il faut ainsi veiller refermer le tube immdiatement aprs y avoir extrait une bandelette-test. 9 10 Tenez la bandelette de sorte que le nom du test soit orient vers le haut. Introduisez la bandelette-test dans la glissire dinsertion du lecteur dans le sens des flches. Poussez la bandelette-test jusqu la bute. Un bip indique la dtection de la bandelette-test
(si l'avertisseur sonore est activ). ID chant. 09:15 202|
A F K P U Z E J O T Y B G L Q V C H M R W
, D I N S X 123 Scan Comptence 09:15 CQ :
202 Code : 101 Par :
aPTT Comptence 09:15 CQ :
202 Code : 101 Par :
aPTT 1:35 Min. 29.05.2015 29.05.2015 Saisissez ou scannez l'ID chantillon. 11 Le symbole du sablier indique que la bandelette-test est prchauffe. Lorsque la bandelette-test est prte (et dans la mesure o l'avertisseur sonore a t pralablement activ), un deuxime signal sonore vous informe que vous pouvez appliquer l'chantillon de comptence. Le symbole de la pipette compte-gouttes clignote pour indiquer que le lecteur est prt effectuer la mesure et attend le dpt de la solution. Un compte rebours est alors lanc. L'chantillon doit tre dpos sur la bandelette-test dans le dlai affich, sans quoi un message derreur s'affiche lcran. 131 5 e c n e t p m o c e d l t e e r t n o c e d t s e T 132 Comptence 09:15 CQ :
202 Code : 101 Par :
aPTT Comptence CQ :
202 Code : 101 Par :
03.06.2015 11:30 09:15 aPTT 51.6 SEC Comptence 29.05.2015 29.05.2015 12 Dposez une seule goutte d'chantillon directe-
ment de la pipette compte-goutte sur la zone de dpt transparente semi-circulaire de la bande-
lette-test. Ne rajoutez pas d'chantillon. Le lecteur met un signal sonore pour avertir que la quantit d'chantillon dpose est suffisante (sous rserve de l'activation pralable de l'avertisseur sonore). Le symbole de la pipette compte-goutte disparat et la mesure commence. Le rsultat du test de comptence s'affiche et le com-
mentaire Comptence est ajout automatiquement. Si vous souhaitez ajouter des commentaires, effleurez Le rsultat est enregistr automatiquement dans la mmoire. Une fois le rsultat affich, effleurez invit retirer la bandelette. Vous serez Retirez la bandelette-test du lecteur. 13 14 Mettez le lecteur hors tension. 15 Nettoyez le lecteur si ncessaire (voir chapitre 8, Maintenance et entretien). Jetez les bandelettes-test usages aprs le test de com-
ptence conformment la rglementation en vigueur dans votre tablissement. 6 Examen des rsultats (mmoire) Le lecteur CoaguChek Pro II peut enregistrer en mmoire jusqu' 2 000 rsultats de mesures patient ainsi que 500 tests de contrle qualit liquide avec leurs dates et heures respectives. De plus, jusqu' 120 paquets de donnes de puce dtalonnage (informations mmorises dans 60 puces de bandelettes-test et 60 puces de solu-
tions de contrle) sont enregistrs. Si vous utilisez des listes d'utilisateur et/ou de patient, jusqu' 5 000 ID utili-
sateur et 4 000 ID patient sont autoriss. Si la mmoire est pleine lorsque vous effectuez une mesure, le rsultat le plus ancien sera supprim auto-
matiquement. Le rsultat le plus rcent est toujours enregistr pour les rsultats patient ainsi que pour les tests de contrle qualit. Pour viter toute perte des rsultats de mesures enregistrs, vous pouvez archiver ces donnes l'aide d'un systme de gestion des don-
nes et de la station d'accueil en option (voir page 139). 133 6
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s t a t l u s r s e d n e m a x E 134 6.1 Consultation des rsultats en mmoire 1 2 3 Placez le lecteur sur une surface plane et exempte de vibrations ou tenez-le l'horizontale. Allumez le lecteur en appuyant sur
. Attendez que le menu principal saffiche. Menu Princ. 09:15 Test Patient Test de CQ Examen rsultats Rglages 29.05.2015 Menu Princ. 09:15 Mmoire 09:15 Test Patient Test de CQ Examen rsultats Rglages Rsultats Patient Rsultats CQ 135 Mmoire 09:15 Tous rsultats PT aPTT 29.05.2015 29.05.2015 29.05.2015 4 5 6 Effleurez la zone Examen rsultats. Slectionnez le type de rsultats afficher. Afficher la mmoire Rsultats Patient Afficher la mmoire Rsultats CQ Slectionnez le(s) paramtre(s) de test afficher. Pour afficher les rsultats patient :
La slection de paramtres n'est possible que si l'ordre de tri a t dfini sur Date/Heure (voir page 58). Si l'ordre de tri a t dfini sur ID patient ou or Nom patient , l'cran de rsultats patient s'affiche directement. Les illustrations suivantes dcrivent les diffrentes fonctions permettant de consulter la mmoire :
Symbole Menu : retour au menu principal Symbole Retour : passez de laffichage dun rsultat de patient la liste des rsultats. Symbole Individuel : liste comportant uniquement les donnes de ce patient Symbole Imprimante : l'icne d'imprimante n'apparat que si la fonction imprimante est active. Dans le cas contraire, elle ne s'affiche pas. Icne de code QR : l'icne de code QR n'apparat que si la fonction d'affichage du code QR est active. Dans le cas contraire, elle ne s'affiche pas. 6
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s t a t l u s r s e d n e m a x E 136 Afficher la mmoire Rsultats patient Cette mmoire contient tous les rsultats de tests patient. Ceux-ci sont classs selon le paramtre que vous avez slectionn pour loption Tri (voir page 58). Si loption Tri est dfinie sur Date/Heure, les rsultats sont filtrs au moyen du paramtre de test prcdemment slectionn, les rsultats les plus rcents tant alors affichs en haut de la liste. Mmoire PID01 28.05.2015 11:31 PID02 27.05.2015 10:10 PID01 26.05.2015 10:15 PID01 25.05.2015 09:58 PID03 24.05.2015 10:03 09:15 Mmoire 09:15 ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 250 28.05.2015 11:31 2.5INR 21%Q Mdecin inform Malade Nouv. lot band. Mmoire ID P : PID01 Smith, Henry 09:15 28.05.2015 11:31 2.5 INR 21 %Q 26.05.2015 10:15 3.0 INR 16 %Q 25.05.2015 09:58 1.7 INR 38 %Q 29.05.2015 29.05.2015 29.05.2015 1 pour afficher l'entre de votre Effleurez et choix l'cran. Effleurez linformation que vous dsirez ouvrir. 2 Linformation est affiche. 3 Effleurez s'affichent. Les rsultats du patient slectionn Si vous choisissez d'afficher les listes relatives au patient, vous ne pouvez pas les filtrer par paramtres de test. L'icne de code QR n'apparat que si la fonction d'affichage du code QR est active. Dans le cas contraire, elle ne s'affiche pas. 4 5 Effleurez de code QR. Effleurez des rsultats. pour afficher le rsultat sous forme pour revenir l'affichage standard Mmoire 09:15 ID P : PID01 Smith, Henry Util : Utilisateur 1 Par :
PT Code : 250 Mmoire 09:15 28.05.2015 11:31 2.5INR 21%Q Mdecin inform Malade Nouv. lot band. 29.05.2015 29.05.2015 Afficher la mmoire des rsultats de CQ (contrle qualit) Dans cette mmoire, tous les tests de contrle qualit liquide effectus sont classs par ordre chronologique. Les rsultats les plus rcents se trouvent en haut de la liste. CQ 09:15 28.05.2015 11:31 CQ 999 Pass 27.05.2015 10:05 CQ 234 Pass 26.05.2015 10:07 CQ 623 Pass 25.05.2015 10:30 CQ 333 Pass 24.05.2015 11:01 CQ 432 Pass 29.05.2015 Mmoire 09:15 CQ :
999 Code : 184 Util : Utilisateur 1 Niveau : 1 Par :
PT Pass :
28.05.2015 11:31 1.2 INR
(1.0 - 1.4 INR) 78 %Q
(53 - 99 %Q) Nouv. lot contrle Nouv. lot band. 29.05.2015 1 2 pour afficher l'entre de votre Effleurez et choix l'cran. Effleurez linformation que vous dsirez ouvrir. Linformation est affiche. 137 6
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s t a t l u s r s e d n e m a x E 138 Cette page est intentionnellement laisse blanche. 7 Fonctionnalits tendues 7.1 Manipulation des donnes Remarque : la fonctionnalit tendue de manipulation des donnes dpend des capacits du systme de gestion des donnes (SGD) utilis. Lorsqu'il est utilis avec la station d'accueil de Roche Diagnostics (disponible sparment), le lecteur CoaguChek Pro II peut se connecter facilement un systme de gestion des donnes (SGD). Les principaux avantages d'une connexion entre le lecteur et un SGD sont les suivants :
Le transfert des listes de patients, des listes d'utili-
sateurs et des rglages du SGD vers le lecteur. Le paramtrage des tches quotidiennes ainsi que le paramtrage gnral du ou des lecteurs peuvent tre effectus de faon plus rapide et plus simple. Le transfert de tous les rsultats de mesures enre-
gistrs avec les ID patient, ID utilisateur et com-
mentaires correspondants du lecteur vers le SGD. Ce transfert de donnes facilite une valuation ultrieure ou un archivage en fonction de vos besoins. 139 7 s e u d n e t s t i l a n n o i t c n o F 140 Le SGD permet l'administrateur systme (tel que le coordinateur de soins) de spcifier les rglages appli-
quer sur une srie de lecteurs au sein d'un mme tablis-
sement ou d'une mme unit (par ex., des hpitaux ou des salles). Tous les lecteurs attribus un site/une unit spcifique possderont ainsi les mmes rglages. Les dif-
frentes listes d'utilisateurs et de patients (correspondant un site ou une unit) sont ainsi disponibles sur leurs lecteurs respectifs. D'autres rglages tels que le Blocage CQ et le Blocage Util. peuvent tre dfinis facilement
(une seule fois) puis dploys vers tous les lecteurs. L'option consistant dfinir un Blocage Util. est uni-
quement disponible lorsque les listes d'utilisateurs ont t cres dans un SGD, enregistres dans le lecteur, et que l'ouverture de session utilisateur est active. Pour davantage de dtails sur l'ouverture de session utilisateur, voir page 76. Pour des informations sur le Blocage Util., voir page 86. PC (option de rglage) Pour une premire connexion au SGD, la communication au sein d'un rseau doit tre paramtre de la faon suivante :
Dans le Menu config., l'option Connexion doit tre dfinie sur PC (voir page 63). La station d'accueil doit tre correctement configu-
re. (Pour plus d'informations, veuillez vous repor-
ter au manuel de la station d'accueil et aux notices techniques stockes dans la station d'accueil mme.) Placez le lecteur sur la station d'accueil qui est connecte au rseau. Le lecteur sera automatique-
ment reconnu par le SGD et pourra tre attribu un site et/ou une unit gr par le SGD (si votre SGD possde cette fonctionnalit). En fonction de la fonctionnalit disponible sur le SGD, ce dernier peut transfrer les paramtres et les listes au lecteur et activer les rsultats de mesure transfrer du lecteur au SGD. 141 7 s e u d n e t s t i l a n n o i t c n o F 142 Listes d'utilisateurs Aprs avoir mis en marche le lecteur, une ouverture de session utilisateur peut tre configure. Quatre con-
figurations sont possibles pour l'ouverture de session Utilisateur :
L'utilisateur est activ mais il n'existe aucune liste disponible :
L'utilisateur peut se connecter via le clavier apparaissant l'cran ou par le biais du scan de code-barres. L'utilisation du lecteur n'est pas limite un groupe prdfini d'utilisateurs. Ainsi, les ID Utilisateurs sont saisis par l'intermdiaire du clavier apparaissant l'cran ou lus par le code-
barres et enregistrs avec les rsultats de mesures uniquement titre informatif. Cette premire configuration est galement disponible sans SGD. L'utilisateur est activ, il n'y a pas de liste disponible et la fonction Liste est dfinie comme tant cache (possible uniquement avec un SGD). Lorsque la fonction Liste est dfinie comme tant cache avec le SGD, laffichage du clavier tactile sur lcran du lecteur est galement automatiquement bloqu. Lutilisateur ne peut se connecter que par le biais du scan de code-barres car aucun clavier tactile napparat lcran. L'utilisation du lecteur n'est pas limite un groupe prdfini d'utilisateurs. Ainsi, les ID utilisateur sont lus par le code-barres et enre-
gistrs avec les rsultats de mesures uniquement titre informatif. Les lecteurs grs par un SGD peuvent recevoir une liste d'utilisateurs. L'utilisateur est activ, une liste est disponible et s'affiche sur l'cran de connexion :
l'utilisateur slectionne l'identifiant dans la liste qui s'affiche. L'utilisateur peut galement tre amen saisir un mot de passe de connexion si l'administrateur l'a configur ainsi. Listes des patients L'utilisateur est activ, une liste est disponible mais elle est dfinie sur cach :
l'utilisateur peut se connecter par le biais du scan de code-barres. L'utilisateur peut galement tre amen saisir un mot de passe de connexion si l'administrateur l'a configur ainsi. En travaillant avec les listes d'utilisateurs : l'utilisation du lecteur est rserve aux utilisateurs de la liste. En dmarrant une mesure patient, une option permettra soit de slectionner un ID patient partir d'une liste de patients en saisissant l'ID patient l'aide du clavier tactile apparaissant l'cran, soit de scanner le code-barres contenant l'ID patient. Si l'ID patient est saisi sur le SGD, il est accompagn d'une entre d'identification suppl-
mentaire. Jusqu' 20 caractres peuvent tre utiliss pour la seconde entre de confirmation (par ex., le nom ou la date de naissance). Quatre configurations sont disponibles pour la saisie de l'ID patient :
L'ID patient est dfini sur option ou requis et aucune liste n'est disponible :
un ID patient peut tre saisi manuellement par le biais du clavier tactile apparaissant l'cran ou lu par le scan du code-barres. L'identifiant patient est enregistr avec le rsultat de la mesure. L'ID patient est dfini sur Non mais une liste est disponible :
La liste d'identifiants patient s'affiche toujours au dmarrage d'une mesure. Vous pouvez ainsi slectionner un patient dans la liste scanner un ID patient l'aide du lecteur de code-
barres crer une nouvelle entre de patient en effleurant la zone Nouv. la place d'un identifiant, ce rsultat sera numrot dans un ordre conscutif. 143 7 s e u d n e t s t i l a n n o i t c n o F 144 Validation de la liste des patients L'ID patient est dfini sur option ou requis et une liste est disponible :
la liste d'identifiants patient s'affiche toujours au dmarrage d'une mesure. Vous pouvez ainsi :
slectionner un patient dans la liste scanner un ID patient l'aide du lecteur de code-
barres crer une nouvelle entre de patient en effleurant la zone Nouv. Vous pouvez lire l'identifiant l'aide du lecteur de code-barres ou saisir un nouvel iden-
tifiant via le clavier tactile apparaissant l'cran. L'ID patient est dfini comme tant cach (unique-
ment possible avec un systme de gestion des donnes) et une liste est disponible :
Lorsque vous lancez le test, l'cran est vierge et la mention Scan s'affiche. Vous pouvez dsormais scanner un ID patient l'aide du lecteur de code-barres. Si l'identifiant patient est dans la liste, le test se poursuit. S'il n'y est pas, un message d'erreur s'affiche. Notez que l'ID patient scann doit dj tre dans la liste envoye du SGD au lecteur. Vous ne pouvez pas utiliser le lecteur pour scanner et saisir un nouvel ID patient si l'ID patient est dfini sur cach . Selon les paramtres du SGD, vous disposez des options suivantes pour la validation de la liste des patients lorsque vous travaillez avec des listes de patients :
Il n'est pas ncessaire qu'un ID patient soit sur la liste pour tre utilis (uniquement si le mode de validation est dsactiv). Le lecteur affiche un avertissement si l'ID patient saisi n'est pas sur la liste. Le lecteur affiche un message d'erreur si l'identi-
fiant n'a pas t trouv dans la liste d'ID patient disponibles. Pour continuer le test, vous devez scanner (si l'ID est cach ) ou slectionner (si l'ID est requis) un ID patient valide. Configuration des identifiants utilisateur et patient Lors de la cration d'identifiants utilisateur et patient, suivez les rgles suivantes :
Lecteur de code-barres Rsultats de mesures enregistrs et commentaires Les identifiants patient peuvent comporter jusqu' 20 caractres alphanumriques, les lon-
gueurs minimale et maximale tant spcifies. Les identifiants utilisateur peuvent comporter jusqu' 20 caractres alphanumriques. On entend par caractre alphanumrique toute combi-
naison de lettres (A Z) et de chiffres (0 9). Un point
(.) et un tiret (-) peuvent aussi tre utiliss. En utilisant un SGD, le lecteur de code-barres peut tre configur pour n'accepter que les symbologies de code-
barres slectionnes. Une liste des symbologies de codes-barres prises en charge est disponible l'annexe A, page 166, et une liste des caractres pris en charge l'annexe A.3, page 169. Le masquage de code-barres peut tre utilis pour liminer tout caractre n'appartenant pas l'identifiant utilisateur. Pour plus d'informations, consultez la section Masques de codes-barres d'identifiants utilisateur et patient , page 165. Lors de l'excution d'une mesure, le rsultat sera enre-
gistr avec les informations supplmentaires telles que l'ID patient, l'ID utilisateur, le type de test effectu ainsi que les ventuels commentaires. Le lecteur comporte par dfaut une srie de commentaires pouvant tre attribus chaque rsultat de mesure. Si vous travaillez avec un SGD, ces commentaires peuvent tre remplacs par ceux du SGD. La nouvelle formulation sera disponible partir de la liste Commentaires du lecteur. Jusqu' 3 commentaires peuvent tre attribus chaque rsultat. 145 7 s e u d n e t s t i l a n n o i t c n o F 146 Les commentaires du lecteur prdfinis par dfaut sont les suivants :
Commentaires de rsultats patient Commentaires de rsultats CQ Asymptomatique Lecteur nettoy Mdecin inform Malade En voyage Prlev. au labo. Pas d'action Erreur de procdure Prend mdicament Devra refaire test Dose modifie Contrle acceptable Lecteur nettoy Mdecin inform Nouv. lot contrle Nouv. numro de lot Nouv. lot band. Nouv. lot band./kit Pas d'action Erreur de procdure Test comptence Refaire test contr. Infirmire avise Flacon de CQ invers. Devra refaire test Pour plus d'informations et pour des renseignements sur les dtails techniques, veuillez vous reporter au manuel de la station d'accueil et aux notices techniques stockes dans la station d'accueil mme. 8 Maintenance et entretien 8.1 Conditions de stockage et d'expdition Stockage Stockez le systme et les bandelettes-test dans l'environnement dans lequel ils sont utiliss. Ne stockez pas le lecteur la lumire directe du soleil ou des tempratures extrmes. Observez les limites de temprature et d'humidit lors du stockage et de l'utilisation du lecteur (voir chapitre 10). 147 8 n e i t e r t n e t e e c n a n e t n a M i 148 Expdition Observez les informations de scurit suivantes lors de l'expdition du lecteur et du bloc-piles. Le non-respect de ces consignes peut entraner des blessures ou un endommagement du lecteur ou du bloc-piles. Si le lecteur est expdi ou transport sur de lon-
gues distances, retirez toujours le bloc-piles, afin d'viter une surchauffe de ce dernier en raison d'un court-circuit dans le lecteur et une dcharge ou un endommagement du bloc-piles ou du lecteur. N'expdiez que des blocs-piles en bon tat. Les blocs-piles endommags doivent tre jets sur place. Voir page 19 pour les risques associs aux blocs-piles endommags et pour plus d'informa-
tions sur la mise au rebut. Pour l'expdition, emballez le bloc-piles de faon qu'il ne puisse pas bouger dans l'emballage. Observez galement les autres rgles nationales applicables. Lors de l'expdition par des tiers (notamment par avion ou service postier), travaillez avec le transpor-
teur pour vrifier si des critres particuliers doivent tre remplis en ce qui concerne les blocs-piles lithium-ion dans le respect des lois nationales ou internationales sur les matires dangereuses et, le cas chant, si un emballage ou un tiquetage spcial sont ncessaires. Pour de courtes distances, par exemple entre plusieurs sites d'un mme tablissement, les utilisateurs peuvent transporter les blocs-piles (installs dans le lecteur ou sparment) par la route sans conditions particulires. 8.2 Nettoyage et dsinfection du lecteur 149 Diffrence entre nettoyage et dsinfection Quand le lecteur doit-il tre nettoy et dsinfect ?
Que nettoyer et dsinfecter ?
Le nettoyage est l'limination physique de salissures organiques (poussire ou autre substance trangre, par exemple) sur la surface du lecteur. La dsinfection correspond l'limination de la plupart des micro-organismes responsables de maladies et des autres types de micro-organismes (agents pathognes diffusion hmatogne), mais pas tous, du lecteur. Nettoyez le lecteur pour liminer toute salissure visible et toute substance organique, afin d'assurer une manipulation scurise et/ou avant la dsinfection. L'extrieur du lecteur et la glissire d'insertion des bandelettes-test doivent tre nettoys et dsinfec-
ts avant d'tre utiliss pour un autre patient. L'extrieur du lecteur et la glissire d'insertion des bandelettes-test doivent tre nettoys et dsinfec-
ts si une quantit excessive de sang (> 20 L) a t dpose. Nettoyage d'entretien : l'utilisation de lingettes dsinfectantes peut conduire une accumulation de rsidus sur la glissire d'insertion des bande-
lettes-test et sur le logement des piles, qui doivent tre limins. Frquence : ds l'apparition d'une accumulation de rsidus visible ou au moins une fois par mois. Dsinfectez le lecteur lorsqu'il prsente des salissures, conformment aux directives de votre tablissement. Les parties suivantes du lecteur peuvent tre nettoyes /
dsinfectes :
La zone situe autour de la glissire d'insertion des bandelettes-test ;
L'cran (tactile) du lecteur ;
Le botier du lecteur (toute la surface du lecteur :
avant et arrire) ;
La glissire d'insertion des bandelettes-test et son couvercle. 8 n e i t e r t n e t e e c n a n e t n a M i 150 MISE EN GARDE Veuillez vous conformer aux directives de dsinfection de votre tablissement. Utilisez des gants. Suivez les instructions suivantes pour procder au net-
toyage/ la dsinfection du lecteur. Tout manquement ces consignes peut entraner un dysfonctionnement du lecteur. Endommagement de l'instrument en raison de l'humidit Assurez-vous quaucun liquide ne pntre dans l'appa-
reil. La prsence d'humidit l'intrieur du lecteur peut entraner le dysfonctionnement de l'instrument. Vrifiez que le lecteur est teint. Ne pulvrisez aucune substance sur le botier du lecteur. Ne pulvrisez aucune substance dans la glissire dinsertion des bandelettes-test. N'immergez pas le lecteur dans du liquide. N'utilisez pas de lingettes ou de cotons-tiges impr-
gns. Essorez toute solution en excs ou absorbez celle-ci l'aide d'une serviette en papier avant d'essuyer la surface du lecteur. 8.3 Agents de nettoyage/dsinfection recommands Utilisez uniquement les solutions pour procder au net-
toyage/ la dsinfection du lecteur (botier et glissire d'insertion des bandelettes-test). Un chiffon doux lgrement humidifi (non mouill) au moyen d'une faible quantit de savon liquide dilu dans l'eau Alcool friction (thanol ou alcool isopropylique 70 %) Dsinfectant base d'alcool (mlange de 1-propanol (400 mg/g), 2-propanol (200 mg/g) et de glutaraldhyde (1,0 mg/g)) 1 Solution d'hypochlorite de sodium 10 % (1 dose de javel pour 9 doses d'eau dionise, renouveler toutes les 24 heures) Lingettes jetables contenant des composs d'ammonium quaternaire, jusqu' 0,5 % (compos unique ou mlange) dans de l'alcool isopropylique
(isopropanol), jusqu' 55 %
MISE EN GARDE N'utilisez pas d'autres dsinfectants/solutions de net-
toyage sur le lecteur (botier ou glissire d'insertion des bandelettes-test). L'utilisation d'autres dsinfectants/
solutions de nettoyage est susceptible d'endommager le lecteur. 1. Vendu dans certains pays sous le nom de Bacillol Plus . 151 8 n e i t e r t n e t e e c n a n e t n a M i 152 8.4 Nettoyage/dsinfection de la partie extrieure (botier du lecteur) Utilisez les solutions recommandes la page 151 pour le nettoyage/la dsinfection de la partie extrieure du botier. Appliquez les solutions pendant plus d'1 minute
(reportez-vous l'tiquette du produit correspondant). Assurez-vous que le volet de la glissire d'insertion des bandelettes-test reste bien ferm lors du nettoyage du botier du lecteur. 1 teignez le lecteur, puis essuyez soigneusement les surfaces (cran tactile, botier) avec un chiffon doux, non pelucheux lgrement humidifi (non mouill). vitez toute accumulation de liquide prs d'un orifice. Assurez-vous quaucun liquide ne pntre dans l'appareil. 2 3 l'aide d'un chiffon sec et propre ou d'un tissu non pelucheux, essuyez toute trace d'humidit aprs avoir nettoy le botier. Vrifiez visuellement qu'il ne reste de trace de solution aucun endroit sur le botier ou l'cran tactile aprs le nettoyage et la dsinfection. Laissez les zones concernes scher au moins 10 minutes avant l'excution du prochain test patient. Si vous remarquez des tranes sur le botier ou l'cran tactile, ou si la surface de l'cran tactile est lgrement trouble, essuyez immdiatement avec un chiffon doux non pelucheux lgrement humidifi l'eau. 8.5 Nettoyage/dsinfection de la glissire dinsertion des bandelettes-test Utilisez les solutions recommandes la page 151 pour le nettoyage/la dsinfection de la glissire d'insertion des bandelettes-test. Appliquez les solutions pendant plus d'1 minute (reportez-vous l'tiquette du produit corres-
pondant) l'aide de cotons-tiges non pelucheux. 1 2 Une fois le lecteur teint, retirez le couvercle de la glissire d'insertion des bandelettes-test pour le nettoyer. (Utilisez votre pouce pour ouvrir le volet de la glissire d'insertion des bandelettes-test en le soulevant). loignez suffisamment le couvercle du lecteur. Rincez ensuite le volet l'eau chaude ou nettoyez-le l'aide des solutions recommandes ci-dessus. Laissez scher le volet de la glissire d'insertion des bandelettes-test au moins 10 minutes avant de le remettre en place. Tenez le lecteur verticalement de telle sorte que la glissire d'insertion des bandelettes-test soit oriente vers le bas. Nettoyez les zones blanches facilement accessibles l'aide d'un coton-tige humidifi. Veillez ce que le coton-tige soit humide et non tremp. Essuyez toute trace d'humidit. 153 8 n e i t e r t n e t e e c n a n e t n a M i 154 MISE EN GARDE Risque d'endommagement de l'instrument Assurez-vous qu'aucun liquide ne pntre dans le lecteur lorsque vous nettoyez la glissire d'inser-
tion des bandelettes-test. La prsence d'humidit l'intrieur du lecteur peut entraner le dysfonc-
tionnement de l'instrument. N'insrez aucun objet dans la glissire dinsertion des bandelettes-test. Cela risquerait d'endom-
mager les contacts lectriques situs derrire la glissire d'insertion des bandelettes-test. Une fois le nettoyage termin :
3 4 Le volet tant retir, laissez scher la glissire d'insertion des bandelettes-test pendant au moins 10 minutes avant de remettre son couvercle en place et de procder un nouveau test. Vrifiez visuellement qu'il ne reste de trace d'humidit aucun endroit sur la glissire d'inser-
tion des bandelettes-test et son couvercle aprs le nettoyage et la dsinfection. Assurez-vous que la glissire d'insertion des ban-
delettes-test et son couvercle sont bien secs avant de les assembler. Remettez le volet de la glissire d'insertion dans son logement. Veillez ce que le volet soit bien referm. Un dclic confirme sa fermeture. 8.6 Nettoyage de la fentre du lecteur de codes-barres La fentre du lecteur de codes-barres doit tre nettoye priodiquement. Utilisez un tissu propre et sec pour essuyer la fentre. 9 Dpannage Message I-001 : Batterie faible Batterie faible I-001 La batterie est faible. Remplacez-la ou rechargez-la le plus vite possible. E-101 : ID patient requis ID patient requis E-101 Un ID patient est requis. Veuil-
lez saisir un ID patient valide. Le lecteur CoaguChek Pro II vrifie continuellement ses systmes pour dceler des problmes inattendus ou indsirables. Ceux-ci peuvent survenir pour des raisons techniques (composants ou consommables dfectueux, facteurs environnementaux) ou suite des erreurs de manipulation ou de procdure. En fonction des circonstances, un message peut s'affi-
cher sur l'cran du lecteur. Ces messages sont marqus d'un symbole, soit pour un message d'erreur. Tous les messages affichs par le systme sont accompagns d'une description de l'erreur et d'une solution possible. pour indiquer le statut, soit Effectuez les actions proposes l'cran pour rsoudre le problme. Si le message d'erreur disparat, vous pouvez continuer utiliser le lecteur comme vous le souhaitez. Si le problme persiste, contactez Roche Diagnostics
(voir page 163). Les deux types de messages sont illustrs ci-dessous :
Description Message de statut Effleurez pour effectuer l'action suivante. Message d'erreur Effleurez indiques pour rsoudre le problme. pour quitter ce message. Suivez les tapes 155 9 e g a n n a p D 156 E-406 : Erreur chantillon Erreur chantillon E-406 Composition dchantillon inapproprie. Vri ez la procdure et relancez le test avec un nouvel chantillon. Vri ez les traitements mdicamenteux du patient. Informations supplmentaires sur l'erreur E-406 Message d'erreur Effleurez indiques pour rsoudre le problme. pour quitter ce message. Suivez les tapes teignez le lecteur et retirez la bandelette-test. Effectuez une nouvelle mesure avec une bandelette-test neuve et du sang prlev un autre site de ponction, cest--dire lextrmit dun autre doigt. Veillez ne pas toucher ni retirer la bandelette-test au cours du processus de mesure. Remarque concernant lerreur E-406 : la bandelette-
test CoaguChek PT peut tre utilise chez les patients recevant un traitement associant des anticoagulants par voie orale et de l'hparine par voie injectable. Pour connatre les concentrations maximales dhparine sans incidence sur la mesure, reportez-vous la notice d'emballage des bandelettes-test. Cependant, il ne faut en aucun cas utiliser de tubes capillaires hparins pour le dpt de l'chantillon. Seuls les tubes capillaires ddis des systmes CoaguChek peuvent tre utiliss. Veillez dposer la goutte de sang sur la bandelette-test dans un dlai de 15 secondes aprs piqre du doigt. Dans de rares cas, les patients aux temps de coagulation anor-
maux ou particulirement longs peuvent voir un message E-406 apparatre sur l'cran du lecteur. Vrifiez les rsultats laide dune autre mthode si ce message derreur persiste aprs que vous avez effectu une nouvelle mesure. Pour de plus amples informations sur l'intervalle de mesure du paramtre, consultez la notice d'emballage correspondante. Erreurs et anomalies sans message d'erreur Certaines anomalies peuvent survenir sans message de statut ou d'erreur. Message Description Absence de message ou anomalie L'affichage du lecteur ne fonctionne pas Attendez 10 secondes et essayez de le redmarrer. Vrifiez qu'il est allum (voir Installation du bloc-
piles partir de la page 38). Le bloc-piles est-il correctement install dans le lecteur ?
Le lecteur s'allume-t-il lors de la connexion de l'adaptateur secteur externe ?
Le bloc-piles se charge-t-il correctement ?
Le lecteur affiche un rsultat inattendu Reportez-vous la notice d'emballage des bandelettes-
test. Arrt automatique Le lecteur s'teint aprs un temps d'inactivit param-
trable (par exemple si vous n'appuyez sur aucune touche ou si vous ne touchez pas l'cran) afin d'conomiser l'nergie. Ractivez le lecteur / l'cran comme indiqu ci-dessous :
Appuyez sur
. Arrt aprs un temps spcifi par l'administrateur systme (dfini par dfaut 5 minutes, paramtrable par l'administrateur systme) 157 9 e g a n n a p D 158 Rinitialisation du lecteur Une rinitialisation du lecteur ne doit tre effectue que si tous les autres recours ont chou. 1 2 3 4 Placez le lecteur sur une surface plane. Appuyez sur la touche Marche/Arrt pendant au moins 12 secondes. Le lecteur s'teint puis se rallume. Le logo Roche s'affiche. Si le logo Roche ne s'affiche pas dans un dlai de 60 secondes, placez le lecteur sur une station d'accueil pendant au moins 15 minutes pour recharger les piles. Le lecteur effectue un contrle du systme. Les crans pour saisir la date et l'heure s'affichent. Saisissez la date et l'heure. Aprs avoir saisi les informations adquates, confirmez chaque cran l'aide de la touche moins que tous les blocages ne soient dsactivs
(voir chapitre 3.5), le lecteur est alors en mode Blocage CQ en raison de la saisie manuelle de la date et de l'heure. Synchronisez la date et l'heure du lecteur avec celles de votre tablissement l'aide de la station d'accueil ; si vous utilisez une connexion sans fil, attendez au moins dix minutes jusqu' la prochaine synchronisation WLAN avant d'effectuer d'autres tests. CoaguChek Init CoaguChek 04.00.00 Date 09:15 Anne : 2015 Heure 09:15 Mois :
Jour :
5 29 Heure :
Minute :
9 59 29.05.2015 am pm 29.05.2015 Mme si votre configuration ne l'exige pas, il est recom-
mand de toujours effectuer un test CQ aprs une rinitialisation du lecteur. 10 Spcifications gnrales du produit 10.1 Donnes techniques Plage de tempratures Humidit relative Altitude maximum Installation Intervalle de mesure Mmoire Interface Alimentation par piles Alimentation Nombre de tests avec un bloc-piles entirement charg Classe de protection Mise hors tension automatique Dimensions Poids chantillon Type dchantillon Volume de lchantillon Interactions
+12 C +32 C (54 F 90 F) 10 85 % (sans condensation) 4300 m Placez le lecteur sur une surface plane, exempte de vibrations, ou tenez-le lhorizontale. Voir notice demballage des bandelettes-test respectives 2 000 rsultats patient et 500 rsultats CQ avec date et heure 120 paquets de donnes de puces d'talonnage (60 codes bandelettes et 60 codes contrles) Listes d'utilisateurs avec jusqu' 5 000 identifiants utilisateur et un 2me ID correspondant (par ex. Nom d'utilisateur) Listes de patients avec jusqu' 4 000 identifiants patient et un 2me et 3me ID patient correspondant (par ex. nom, date de naissance) cran tactile et lecteur de codes-barres Bloc-piles universel pour le lecteur CoaguChek Pro II Adaptateur secteur :
Tension primaire : 100240 V / 5060 Hz / 350150 mA Tension secondaire : 12 V DC / 1,25 A Environ 60 (PT/INR) Environ 20 (aPTT/temps de mesure 5 minutes) III Rglable de 1 60 minutes 187 x 97 x 43 mm 280 g (sans le bloc-piles) Voir notice demballage des bandelettes-test Voir notice demballage des bandelettes-test Voir notice demballage des bandelettes-test 159 0 1 t i u d o r p u d l s e a r n g s n o i t a c i f i c p S 160 Conditions d'entreposage Plage de tempratures Lecteur (sans bloc-piles) Plage de tempratures Lecteur (avec bloc-piles)*
Humidit relative
-25 C +70 C (-13 F +158 F)
-10 C +35 C (+14 F +95 F) 10 85 % (sans condensation)
* Par des tempratures suprieures +70 C/158 F, le bloc-piles peut fondre et endommager le lecteur. Par des tempratures infrieures -10 C/+14 F, le bloc-pile n'est pas assez puissant pour garantir le fonctionnement de l'horloge interne. Conditions de transport Plage de tempratures Lecteur (sans bloc-piles) Plage de tempratures Lecteur (avec bloc-piles)*
Humidit relative
-25 C +70 C (-13 F +158 F)
-10 C +70 C (+14 F +158 F) 10 85 % (sans condensation)
* Par des tempratures suprieures +70 C/158 F, le bloc-piles peut fondre et endommager le lecteur. Par des tempratures infrieures -10 C/+14 F, le bloc-pile n'est pas assez puissant pour garantir le fonctionnement de l'horloge interne. 10.2 Informations supplmentaires Consommables / accessoires Article CoaguChek PT Test CoaguChek aPTT Test CoaguChek PT Controls CoaguChek aPTT Controls Description Bandelettes-test PT pour le lecteur CoaguChek Pro II Bandelettes-test aPTT pour le lecteur CoaguChek Pro II Contrles liquides en option
(niveau 1, niveau 2) pour le systme CoaguChek Pro II Remarques dition internationale
(non disponible aux tats-Unis) CoaguChek Capillary Tubes/Bulbs Tubes capillaires Universal Battery Pack Handheld Base Unit Kit Ractifs et solutions Limitations lies au produit Bloc-piles rechargeable Station d'accueil et manuel de l'utilisateur Les fournitures sont disponibles auprs de Roche Diagnostics. Contactez votre reprsentant Roche Diagnostics local. Les caractristiques et limites du produit sont prcises dans la notice demballage des bandelettes-test et des contrles. 161 0 1 t i u d o r p u d l s e a r n g s n o i t a c i f i c p S 162 Informations sur les licences dutilisation du logiciel Ce produit comprend des modules logiciels dvelopps sous licences open source. Le code source de ce logiciel peut tre demand sur un support dchange de donnes standard du fabricant l'adresse suivante :
Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim, Allemagne Les conditions accompagnant la licence publique gn-
rale (GPL) sont disponibles (en anglais seulement pour des raisons d'ordre lgal) dans un fichier PDF (nom de fichier License_txt.PDF ) sur le CD fourni avec le pr-
sent manuel. Les conventions de droits dutilisation com-
pltes sont aussi enregistres sous forme de fichier texte
(nom de fichier License.txt ) sur la station d'accueil. Vous pouvez consulter ce fichier en connectant le socle un ordinateur au moyen du cble USB. Pour des instructions dtailles sur cette procdure, veuillez vous reporter au manuel de l'utilisateur de la station d'accueil. La reproduction et la distribution de copies fidles de ce document de licence sont autorises condition qu'aucune modification n'y soit apporte. Rparations Coordonnes de Roche Toute rparation et autres modifications apportes au lecteur ne doivent tre effectues que par des personnes habilites par Roche Diagnostics. Pour toute question concernant le systme CoaguChek Pro II dont la rponse ne se trouve pas dans ce manuel, veuillez contacter votre reprsentant Roche Diagnostics local. Si vous ne disposez pas des coordonnes :
Consultez notre site Web l'adresse www.roche.com. Slectionnez Roche in your country en haut de la page, puis choisissez votre pays pour trouver les coordonnes locales correspondantes ou Consultez notre site Web l'adresse www.coaguchek.com. Localisez la zone CoaguChek Worldwide sur la page et slectionnez votre pays. 163 0 1 t i u d o r p u d l s e a r n g s n o i t a c i f i c p S 164 11 Garantie Les dispositions lgales relatives la vente et aux garanties des biens de consommation dans le pays dachat prvalent. A Annexe A.1 Masques de codes-barres d'identifiants utilisateur et patient Caractre de masque de code-barres AZ, 09 Dollar ($) Astrisque (*) Tilde (~) Plus (+) Accent circonflexe (^) Dfinition S'il n'est pas prcd du symbole accent circonflexe (^), le caractre de donnes de scan doit tre le mme que le caractre de masque. Ce carac-
tre n'est pas enregistr comme faisant partie de l'ID. Si les caractres ne sont pas identiques, les donnes de scan ne forment pas un ID valide. Le caractre de donnes de scan dans cette position est conserv comme faisant partie de l'ID. Le caractre de donnes de scan dans cette position n'est pas conserv comme faisant partie de l'ID. Le caractre de donnes de scan dans cette position doit tre un chiffre
(09). Il n'est pas conserv comme faisant partie de l'ID. Si le caractre de donnes de scan n'est pas un chiffre, les donnes de scan ne forment pas un ID valide. Le caractre de donnes de scan dans cette position doit tre un caractre alphabtique (AZ). Il n'est pas conserv comme faisant partie de l'ID. Si le caractre de donnes de scan n'est pas un caractre alphabtique, les donnes de scan ne forment pas un ID valide. Ce caractre de masque indique que le caractre de donnes de scan doit tre gal au caractre suivant dans le masque de code-barres aprs le ^ , et que le caractre de donnes de scan est conserv comme faisant partie de l'ID. Si le caractre de donnes de scan n'est pas gal au caractre de masque suivant le ^ , le code-barres lu ne correspond pas un ID valide. Longueur maximale autorise pour un masque de code-barres :
60 caractres pour les codes-barres 1D 300 caractres pour les codes-barres 2D 165 A e x e n n A 166 A.2 Exemple de symbologies de codes-barres Une lecture incorrecte de code-barres peut entraner une identification incorrecte du patient et par cons-
quent des dcisions thrapeutiques inappropries. Lors de la cration de codes-barres patient ou utilisateur, suivez toujours les normes IEC/ISO internationales en vigueur pour la symbologie des codes-barres respectifs. Assurez-vous notamment que la taille du code-barres et la qualit d'impression (telles que dfinies par les normes ISO/IEC 15416 et 15415) sont adquates. Une taille et/ou une qualit d'impression inadquates peuvent entraner des erreurs de dcodage. En outre, chaque utilisateur doit contrler la plausibilit de toutes les donnes scannes et affiches sur l'instrument. Pour rduire les risques d'erreur de lecture, il est vive-
ment recommand d'utiliser les options de configuration pour la validation des ID patient et/ou utilisateur dans la mesure o votre procdure de travail le permet. Ces options sont :
le contrle de l'ID par rapport la liste ou le contrle de la longueur de l'ID1 l'utilisation de codes-barres avec check digits Assurez-vous que le code-barres est toujours entire-
ment couvert par le faisceau de lumire verte lors du scan. 1. Si aucune liste d'utilisateurs/patients ne peut tre utilise, il est recommand de dfinir au moins une longueur minimale pour les ID, mme si votre tablissement utilise diverses tailles d'ID. 167 AVERTISSEMENT viter les lectures incorrectes de codes-barres EAN 13 et 2 parmi 5 entrelac Les codes-barres EAN 13 et 2 parmi 5 entrelac, bien qu'ils soient trs rpandus, ne sont pas recommands pour l'identification des patients/utilisateurs. Une lecture incorrecte de code-barres EAN 13 ou 2 parmi 5 entrelac peut entraner une identification incorrecte du patient et par consquent des dcisions thrapeutiques inappro-
pries. S'ils sont tout de mme utiliss:
assurez-vous que la cration et la reproduction des codes-barres rpondent aux exigences de qualit les plus strictes. pour les codes-barres EAN 13: les squences ini-
tiales 978 (ISBN) et 979 (ISMN) ne doivent pas tre utilises car elles seront ignores en tant que partie d'un code ID. Les chantillons de codes-barres illustrs ci-aprs sont fournis titre d'exemple uniquement. S'ils sont imprims, ils peuvent tre utiliss pour vrifier le fonctionnement du lecteur de codes-barres. Toutefois, ils ne doivent pas tre utiliss en tant que rfrences pour la taille ou la rsolu-
tion de vritables codes-barres d'ID patient ou utilisateur. Lorsque vous crez des codes-barres de patients ou d'utilisateurs, veuillez toujours respecter les exigences des normes ISO/IEC 15416 et 15415 en matire de taille et de rsolution, ainsi que les spcifications suivantes. Rsolution d'impression Spcifications recommandes 300 dpi de prfrence 200 dpi minimum Contraste par rflexion 70 % ou plus Note de symbole Note C ou suprieure Note B de prfrence Les notes de symbole, allant de A F, sont attribues en fonction de l'analyse de plusieurs lments de qualit. 0,16 mm (codes-barres linaires) 0,20 mm (codes-barres 2D) Largeur de module
(minimum) Remarques La rsolution 200 dpi peut entraner des problmes de rapport barre large/barre troite. Un fini mat est prfrable un fini brillant. Selon les paramtres de note de qualit pour un code-barres spcifique, il se peut que la note C soit insuffisante en cas de mouve-
ment, de rflexion ou de mauvais clairage. A e x e n n A 168 Codabar Code 39 Code 93 Code 128 EAN 13 2 parmi 5 entrelac PDF417 Code QR DataMatrix A.3 Caractres pris en charge pour les codes-barres 2D Le lecteur de codes-barres 2D peut lire les caractres appartenant aux intervalles unicode suivants :
Latin de base (0021007E) Supplment latin 1 (00A100FF) Latin tendu-A (0100017F) Le lecteur de codes-barres 2D ne prend pas en charge les caractres asiatiques. 169 A e x e n n A 170 Cette page est intentionnellement laisse blanche. B Annexe B.1 Supplment relatif aux Squences de tests observs Squence de tests observs
(OTS ou Observed Test Sequence) La fonction Squence de tests observs (OTS) permet un observateur (superviseur) d'valuer et d'enregistrer les rsultats d'un utilisateur (par ex. pour le renouvelle-
ment de la certification). L'observateur suit un utilisateur pendant un test afin de vrifier que le test est effectu selon la procdure recommande. Il value ensuite le rsultat et valide ou non l'utilisateur. Cette valuation est enregistre avec le rsultat du test et peut tre accompagne de commentaires. Les options Squence de tests observs ne peuvent tre configures qu'avec un SGD. Par consquent, la dispo-
nibilit des options de configuration lectronique varie en fonction du logiciel de gestion de donnes utilis dans votre tablissement. Consultez votre administrateur systme. 171 B e x e n n A 172 Utilisation de la fonction OTS La demande de Squence de tests observs vient du SGD. La prsence du symbole sur la touche Test Patient indique une demande d'OTS en attente. Menu Princ. 09:15 Test pat. - OTS 09:15 Observateur 09:15 Test pat. - OTS 09:15 Test Patient OTS activ Test de CQ Connex. observateur Examen rsultats Test Patient Rglages Quitter Alan Smithee Ann Casey Scan OTS activ Connex. observateur Test Patient 29.05.2015 29.05.2015 29.05.2015 29.05.2015 Effleurez Test Patient. Observateur :
1 Dans le menu Test pat. - OTS, la touche Test Patient est grise (dsactive) jusqu' ce que l'observateur se connecte. 2 3 4 Effleurez Connexion observateur. Attendez que la liste des observateurs saffiche. Slectionnez votre identifiant observateur en effleurant la touche correspondante ou scannez votre ID utilisateur (qui est galement votre ID observateur). Seuls les utilisateurs disposant de droits d'observation OTS sont rpertoris dans la liste Connexion observateur. 5 6 7 Saisissez votre mot de passe (facultatif). Une fois le mot de passe saisi, effleurez pour vous connecter. Le menu Test pat. - OTS s'affiche nouveau. La touche Test Patient est active. Remettez le lecteur l'utilisateur qui peut alors effectuer le test patient sous surveillance . Test pat. - OTS 09:15 Retirer 09:15 Connex. observateur OTS activ Connex. observateur Test Patient 29.05.2015 29.05.2015 173 Observateur OTS effectu :
09:15 Pass Fail I-010 Observateur ALAN SMITHEE, connectez-vous a n de complter le test OTS. Rsultat mesure OK ?
Refuser Valider Comment. :
29.05.2015 Effleurez Test Patient. Utilisateur :
1 Effectuez le test patient comme l'accoutume. Une fois le test ralis, l'observateur doit effectuer les actions suivantes. 5 Remettez le lecteur l'observateur. 2 Observateur :
Effleurez 3 pour vous connecter nouveau. Aprs avoir saisi votre mot de passe, effleurez 4 pour procder l'valuation. valuez les performances de l'utilisateur en effleurant Pass ou Fail. valuez le rsultat du test en effleurant Valider ou Refuser. Effleurez Appuyez sur Test pat. - OTS. pour ajouter un commentaire. pour revenir l'cran 7 8 6 Les informations OTS sont enregistres avec le rsultat du test. B e x e n n A 174 Cette page est intentionnellement laisse blanche. C Annexe C.1 Option : rseau sans fil (WLAN) Article Lecteur CoaguChek Pro II Lecteur CoaguChek Pro II Remarque prliminaire Cette annexe a t rdige pour expliquer les principes de communication sans fil du systme CoaguChek Pro II1 et pour aider la ou les quipes de gestion/d'informatique de votre tablissement dployer efficacement le sys-
tme CoaguChek Pro II sur votre rseau sans fil. La capacit de votre lecteur communiquer sans fil dpend de votre configuration systme. Description Lecteur Lecteur, quip d'une fonctionnalit WLAN Numro de rfrence 07237944190 07210841190 Pour obtenir des informations sur l'enregistrement du WLAN, voir l'addenda WLAN registration information, Addendum to the Operator's Manual for the CoaguChek Pro II meter (Informations sur l'enregistrement du WLAN, addenda du manuel d'utilisation du lecteur CoaguChek Pro II) l'adresse www.coaguchek.com 1. Le systme CoaguChek Pro II est certifi par la Wi-Fi Alliance. 175 C e x e n n A 176 Explications Le lecteur CoaguChek Pro II ne peut tre configur pour la communication sans fil que par un systme de gestion des donnes. Le systme de gestion des donnes (SGD) est galement utilis pour rgler et configurer le lecteur afin qu'il se connecte au rseau local sans fil (WLAN1) d'un hpital en particulier. Les WLAN utilisent des ondes lectromagntiques dans la bande de frquence des 2,4 GHz pour la transmission des donnes sans fil2. Le systme CoaguChek Pro II est conforme au standard IEEE 802.11g (bande des 2,4 GHz)3. Le systme est rtro-
compatible avec le standard 802.11b. Lors de la commu-
nication sans fil avec un point d'accs (PA), le lecteur CoaguChek Pro II reconnat la configuration existante de protocole WLAN du PA (802.11b ou 802.11g) et transmet automatiquement les donnes l'aide du protocole de communication appropri4. La perte de signal ou d'accs la bande passante d'un client particulier peut varier en fonction des situations suivantes : type et nombre de clients, performances du point d'accs, prsence de perturbations lectromagn-
tiques et autres facteurs potentiellement interfrents comme des murs de bton. Le lecteur CoaguChek Pro II utilise un protocole de com-
munication par rafales, qui ne consomme de la bande passante que s'il y a rellement des donnes trans-
mettre. Compare d'autres applications, comme la voix sur IP (VoIP) ou les applications multimdia, la consom-
mation de la bande passante par le lecteur est minime. Si le rseau WLAN auquel le lecteur CoaguChek Pro II essaie de se connecter est dgrad, la conception du lecteur minimise l'impact sur le fonctionnement. 1. 2. 3. 4. Le WLAN est galement dsign sous les noms de rseau local sans fil ou Wi-Fi. Pour un bon fonctionnement de la communication sans fil, le module sans fil doit d'abord tre configur par votre administrateur systme. Si le lecteur CoaguChek Pro II est conforme au standard 802.11g, il n'utilise que les canaux 1 11. Les canaux 12 14 ne sont pas utiliss par le systme. Les rseaux WLAN sont organiss en cellules. Gnrale-
ment, un rseau WLAN consiste en un ou plusieurs points d'accs (PA) connects au rseau local (filaire) et en un ou plusieurs clients, par exemple les lecteurs CoaguChek Pro II et d'autres clients comme les ordinateurs portables. Mise en uvre technique Avant de connecter un dispositif sans fil un rseau sans fil, il est recommand d'effectuer une tude de site WLAN. Le but d'une telle tude est de s'assurer que les points d'accs fourniront une couverture et des perfor-
mances suffisantes pour prendre en charge toute nou-
velle application ou tout nouveau dispositif de radiofr-
quence (RF). L'tude dtaillera galement les signaux RF, notamment tous les rseaux WLAN existants ainsi que tous les signaux RF en concurrence et les interfrences
(structure lie et autres quipements/dispositifs sans fil). Dans le cadre de la mise en place du systme CoaguChek Pro II en RF, il est recommand de relier au moins une station d'accueil la terre. Une station d'accueil en rseau permet une redondance en cas de dysfonctionnement ou d'interruption du rseau sans fil. Si le lecteur CoaguChek Pro II en RF est utilis dans une zone prsentant un faible signal ou des interfrences, il est recommand d'installer une station d'accueil connec-
te pour assurer une redondance. La redondance de la station d'accueil connecte permet une transmission immdiate des rsultats patient lorsque le lecteur est insr dans la station d'accueil. 177 C e x e n n A 178 Le systme RF actuel consiste en une antenne et un systme sur puce (SoC) en WLAN ainsi que d'autres composants. Le systme sur puce en WLAN est le cur du systme WLAN. Le systme RF utilis dans le lecteur CoaguChek Pro II est conforme aux spcifications suivantes :
Son systme sur puce en WLAN prend en charge les standards IEEE 802.11b et 802.11g. Il fonctionne parfaitement avec les autres transmetteurs certifis Wi-Fi. Il met galement en uvre les mcanismes de scurit (WPA entreprise et WPA person-
nel), Wi-Fi Protected Access 2 (WPA2 entreprise et WPA2 personnel) et Wired Equivalent Privacy
(WEP) avec le protocole Temporal Key Integrity Protocol (TKIP) et le standard Advanced Encryption Standard (AES). Le certificat Wi-Fi d'interoprabilit du lecteur CoaguChek Pro II est accessible l'adresse http://certifications.wi-fi.org/search_products.php. Un glossaire des termes, une foire aux questions et d'autres sujets lis la technologie Wi-Fi sont disponibles sur le site de la Wi-Fi Alliance
(http://www.wi-fi.org/). Les canaux utiliss dans la bande des 2,4 GHz sont les canaux 1 11. Ce sont les canaux autoriss par la loi aux tats-Unis. (Les canaux 12 14 ne sont pas utiliss par le lecteur CoaguChek Pro II.) La puissance de sortie RF est d'environ 15 dBm une vitesse de donnes de 54 Mbps. Fonctions RF spcifiques et spcifications de performances efficaces Le systme CoaguChek Pro II permet une connexion un rseau sans fil (WLAN/Wi-Fi). Ce module ne peut tre configur que par un systme de gestion des donnes (SGD), qui active la communication sans fil du lecteur et ses capacits de transfert des don-
nes. La connexion sans fil peut aider garantir que les mises jour des informations du SGD sont immdiate-
ment envoyes tous les lecteurs du rseau. Les lecteurs disposant de l'option sans fil intgre et active utilisent la station d'accueil pour la recharge et/ou en tant qu'option de communication redondante pour changer des donnes avec le SGD. Le lecteur doit galement tre plac sur la station d'accueil si l'hpital change les protocoles de scurit. Dans ce cas, il est possible que tous les lecteurs soient bloqus jusqu' tre chargs et reconfigurs avec le nouveau protocole. Comme dcrit ci-dessus, le lecteur CoaguChek Pro II est conforme au standard 802.11g, ce qui se traduit par les spcifications de performances RF suivantes :
179 C e x e n n A 180 Le lecteur CoaguChek Pro II est capable de transfrer un SGD appropri, via le WLAN, un ensemble de donnes qui peut contenir jusqu'
1 000 enregistrements de rsultats, 100 enregistre-
ments de lots de bandelettes et de contrle, 500 enregistrements d'ID utilisateur, et ce en moins de 15 minutes lorsqu'il fonctionne dans un environ-
nement WLAN normal (administration WLAN cor-
recte, population normale d'autres clients, modle de scurit pris en charge activ). Immdiatement aprs la fin du test (et lors du retour l'cran du menu principal), le lecteur CoaguChek Pro II essaie de se connecter au SGD. Conformment la norme de communication POCT1-A, le SGD doit reconnatre la demande de connexion du lecteur et envoyer une requte de rsultat. Le lecteur n'enverra le rsultat qu' la rception de cette requte. Le temps effectif de transmission des rsultats dpend donc de l'infra-
structure, de la charge de travail du SGD, etc. Toutefois, lorsque le SGD envoie une requte, le lecteur rpond en quelques secondes. Un lecteur CoaguChek Pro II dot d'une connexion sans fil active communique les rsultats aprs chaque test ou, s'il est inactif, essaie automatique-
ment de communiquer avec le SGD toutes les 10 minutes. La distance pour la connexion directe entre le lecteur CoaguChek Pro II et le point d'accs (air, vue directe, faibles perturbations) peut gnralement atteindre 15 20 mtres. La distance relle dpend du positionne-
ment des antennes du point d'accs et d'autres propri-
ts topologiques de l'espace entre le dispositif WLAN et le PA. En outre, un contrle dynamique de la puissance de transmission du point d'accs peut rduire la distance maximale entre le dispositif WLAN et le PA entre lesquels la communication peut avoir lieu. Le systme CoaguChek Pro II est conu de manire coexister avec les autres dispositifs de communication sans fil. Le systme CoaguChek Pro II ne dispose PAS de fonction sans fil en temps rel ni mme de dure critique. Il ne communique que des champs de donnes uniques et numriques. Il ne communique PAS de donnes de longueurs d'ondes continues. Remarque : une mauvaise connectivit au WLAN n'affecte pas le fonctionnement du lecteur mais peut retarder la communication des rsultats au SGD. Les utilisateurs doivent tre conscients que la communi-
cation en temps rel des donnes ne peut pas tre garantie par le lecteur CoaguChek Pro II. Lors de l'change de paquets de donnes volumineux, un lger retard de la rponse du lecteur peut avoir lieu. 181 C e x e n n A 182 Cette page est intentionnellement laisse blanche. 183 Index A Accessoires ............................................................ 161 Adaptateur .................................................................33 Adaptateur (alimentation) ...................................33 Administrateur systme .................................7275 Alimentation Contraste ....................................................................49 Contrle qualit Blocage ..................................................... 83, 102 Mmoire .......................................................... 137 Prparation ..................................................... 118 Rsultat ...................................................125, 132 Connecteurs de chargement
(station d'accueil) ...........................................29 Couvercle de la glissire d'insertion des bandelettes-test ..................... 153 Aperu lments du lecteur .......................................28 Rglages ......................................................4548 Application dun chantillon de sang .................................................................... 108 Arrt Auto ..................................................................62 Autopiqueur ........................................................... 108 Avertisseur sonore ..................... 60, 106, 121, 130 B Bandelette-test Insertion ........................................ 106, 121, 130 Symbole ........................................ 106, 121, 130 Blocage Contrle qualit ..................................... 83, 102 Utilisateur ...........................................................86 Bloc-piles Installation ou remplacement ..............3640 C Caractristiques du produit ............................. 159 Clavier ...................................................................... 100 Code de la puce dtalonnage ...........................98 Code QR ..............................................................6466 Code-barres ........................................ 100, 105, 122 Masques .......................................................... 165 Symbologies ................................................... 168 Commentaires Ajout ................................................................. 113 Conditions dutilisation ............................... 27, 159 Confirmation rsultats ................................. 51, 112 Connexion ...........................................................6368 Consommables ..................................................... 161 Consulter les rsultats ..............................133146 D Date ..............................................................................54 Dpannage ............................................................. 155 Dsinfection ..................................................150154 E chantillon de comptence Appliquer ......................................................... 132 chantillon de sang (mesure) ..................93115 chantillon de sang capillaire
(mesure) ...........................................................93115 cran .................................................................... 4957 Format .................................................................56 Icnes .......................................................... 3032 Examen rsultats Transfert des donnes ......................139141 G Garantie ................................................................... 164 H Heure ...........................................................................55 Humidit relative ........................................... 27, 159 I Icnes Aperu ......................................................... 3032 Emballage ............................................................5 Goutte ............................................................... 107 Pipette compte-gouttes ....................123, 131 Plaque didentification .....................................5 Sablier ........................................... 107, 123, 131 ID Admin. ........................................................... 7275 x e d n I 184 ID patient ....................................................................77 ID utilisateur ..............................................................76 Imprimante ................................................................68 Intervalle CQ .............................................................80 Intervalle de mesure ........................................... 159 Intervalle person. .............................................80, 81 L Langue ........................................................................52 Lecteur Aperu .................................................................28 Rinitialisation ............................................... 158 Lecteur de code-barres ........................................29 Licence du logiciel ............................................... 162 Liste d'utilisateurs .......................................101, 142 Liste des patients ........................................104, 143 M Mmoire Contrle qualit ............................................ 137 Rsultat du patient ...................................... 136 Touche ............................................................. 135 Messages derreur ............................................... 155 Mesure Effectuer .................................................102115 Prparation ........................................................97 Mise au rebut ..................................18, 34, 96, 114,
.............................................................................126, 132 Mise en marche du lecteur ......................... 3541 Mise sous tension ...................................................99 Mise sous tension du lecteur .............................99 Mot de passe ......................................................... 101 N Nettoyage .......................................................150154 Botier du lecteur .......................................... 152 Glissire d'insertion des bandelettes-test ............................................ 153 O Options ................................................................ 5868 P PC ................................................................................. 67 Plage de tempratures .........................27, 93, 159 Port infrarouge ........................................................ 29 Principe du test ....................................................... 13 Processus de coagulation .................................108 Puce d'talonnage .......................................... 9798 Insertion ............................................................. 98 Pulpe du doigt .......................................................108 Q Quitter .......................................................................101 R Rglage ID ......................................................... 7078 Aperu ................................................................ 70 Rglages Arrt Auto ......................................................... 62 Avertisseur sonore ......................................... 60 Code QR ..................................................... 6466 Confirmation rsultats .................................. 51 Connexion .................................................. 6368 Contraste ........................................................... 49 Date ..................................................................... 54 cran ............................................................ 4957 Format d'affichage ......................................... 56 Heure .................................................................. 55 ID Admin. ................................................... 7275 ID patient ........................................................... 77 ID utilisateur ..................................................... 76 Imprimante ........................................................ 68 Langue ............................................................... 52 Options ........................................................ 5868 PC ......................................................................... 67 Rglage ID ................................................. 7078 Slection paramtres .................................... 69 Test URG ............................................................ 88 Tri ......................................................................... 58 Units .................................................................. 50 Rglages CQ ..................................................... 7985 Rinitialisation .......................................................158 Rsultat de test (contrle qualit) ........125, 132 Rsultat du test (test patient) ..........................110 RF (radiofrquence) .....................................23, 177 S Scan (bouton) .................................... 100, 105, 122 Scurit Protection contre les infections ............................................................17 Qualification de lutilisateur ........................17 Slection paramtres ..........................69, 106, 135 Squence de tests observs
(OTS) ................................................................171173 Solutions de contrle de la qualit Appliquer ........................................................ 124 Prparation ..................................................... 118 Puce d'talonnage ....................................... 122 Station d'accueil ................................29, 36, 41, 67,
.........................................................139141, 161, 177 Stockage ................................................................. 147 Symboles Messages derreur ....................................... 155 T Tension .......................................................................27 Tension d'alimentation ................................ 27, 159 Test comptence Prparation ..................................................... 128 Test URG Configurer ..........................................................88 Effectuer .......................................................... 115 Thromboplastine .....................................................13 Transfert des donnes ..............................139141 Tri ..................................................................................58 U Unit (rsultat du test) ....................................... 110 Units (de mesure) .................................................50 Utilisateur Blocage ...............................................................86 Mot de passe ................................................. 101 Quitter .............................................................. 101 V Valeur cible ...............................................................82 Wi-Fi .............................................................................24 WLAN ..............................................................175181 185 x e d n I 186 Cette page est intentionnellement laisse blanche. ACCU-CHEK, COAGUCHEK et SAFE-T-PRO sont des marques de Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Allemagne www.roche.com www.coaguchek.com www.poc.roche.com R F 1 1
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1 2 3 4 | Label | ID Label/Location Info | 1.42 MiB |
CoaguChek Pro II Coagulation Meter
[REF] 07210841 This device transmitter LV ab epee on D-68305 Mannhei 12V===125A Made in Come
[GTIN] 00064562212589
[SN] x00 Wa
(t0)Lo06zv60220
1 2 3 4 | Authorization | Cover Letter(s) | 60.04 KiB |
Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Industry Canada Certification & Engineering Bureau 3701 Carling Ave. Bldg. 94 Ottawa, On K2H 882 August 4, 2015 TO WHOM IT MAY CONCERN We the undersigned, hereby authorize Roche Diagnostics GmbH, Sandhofer Strasse 116, 68305 Mannheim Germany, to act on our behalf in all manners relating to application for rization, including signing of all documents relating to these matters for the equipment autho oche Diagnostics GmbH, on our behalf CoaguChek Pro IL. Any and all acts carried out by R:
shall have the same effect as acts of our own. The authorization is valid for (expiry date): unlimited Ath +/y/200 Sincerely, Tony Heleine Principal R&D Engineer Roche Diabetes Care, Inc 9115 Hague Road Indianapolis, IN, USA 46060 Phone: (317) 521-3404
1 2 3 4 | ConfidentialityRequestLetter | Cover Letter(s) | 193.70 KiB |
CONFIDENTIALITY REQUEST for Certification Service in USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 09-Dec-2013 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b) (4) of the Freedom of Information Act, we requests confidentiality for the following products:
ECC ID Model name VO9UU18 HBM 4 ACCU-CHEK Inform II (02) / CoaguChek XS Pro / cobas h232 For the product stated above, we request permanent confidentiality for exhibits which contain Operational Description, Block Diagram, Schematics, Parts Lists or Tune Up Information. The above exhibits contain our trade secrets and proprietary information that could be of benefit to our competitors. If you have any questions, please feel free to contact me at the address shown below. Sincerely,
(signed) ZRH Ze Name: p.p. Dr. Andreas Staubert Company: ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM Address: 9115 Hague Road, 46250-0457 Indianapolis (IN), USA Phone: +1 (317) 521 2000 Fax: +1 (317) 521 2000 Email: Andreas.staubert@roche.com
1 2 3 4 | CoverLetter DeclarationOnTestData | Cover Letter(s) | 93.57 KiB |
Receiver Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Industry Canada Spectrum Engineering Branch 3701 Carling Avenue, Building 94 Ottawa, Ontario K2H 8S2 Subject: Validity of Test Results Date: 02-Nov-2015 FCC Certification Number: VO9UU18 IC Company Number: 3100A UPN: UU18 HVIN (Hardware Version CoaguChek Pro Il PMN: CoaguChek Pro II Identification Number):
HMN: (Host Marketing Name) CoaguChek Proll) FVIN: {Firmware Version identification Number) To Whom It May Concern:
We, Roche Diagnostics GmbH, Sandhofer Strasse 116;
68305 Mannheim Germany, hereby declare that the test results from Test Reports:
1-5863/13-10-05, Issue Date: 12/18/2014 (SAR WLAN b/g) 1-5863/13-10-07, Issue Date: 12/04/2014 (FCC WLAN b/g) Roche Diagnostics GmbH Diagnostics Division Roche Diagnostics GmbH; Sandhofer StraBe 116; D-68305 Mannheim; Telefon +49 621 759 0; Telefax +49 621 759 2890 Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschaftsfihrung: Dr. Ursula Redeker, Sprecherin; Edgar Vieth -
Aufsichtsratsvorsitzender: Dr. Severin Schwan accurately represent the test results of our device. There are no hardware nor software changes between the current sold device compared to the device tested in the above mentioned report. So this report is still applicable to the device:
Manufacturer: Roche Diagnostics GmbH Model: CoaguChek Pro II FCC ID: VO9UU18 IC: 3100A-UU18 Sincerely, Claas Andreae, Head of Design Verification 4o ok
<Signdtdre>
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1 2 3 4 | CoverLetter PermissiveChangeRequest | Cover Letter(s) | 172.94 KiB |
Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Industry Canada Spectrum Engineering Branch 3701 Carling Avenue, Building 94 Ottawa, Ontario K2H 882 27 October 2015 PCII Request / Re-assessment HBM 4, FCC ID: VO9UU1B8 granted on 12/12/2013 and IC: 3100A-UU18 granted on 12/12/2013 To whom it may concern Pursuant to CFR 2.1043 and RSP-100, ROCHE DIAGNOSTICS GmbH hereby requests a Permissive Change Class II / Re-assessment. Reason:
- Implementation of wireless functionality in new portable host device (CoaguChek Pro II) Modifications:
- Add portable host device to modular approval The following new exhibits will be uploaded:
- RE Exposure Info
- External/Internal Photos, Schematics, Block Diagram, Operational Description
- User Manual Sincerely, L a " D : K A c Abfllif er Andreas Weller O2~Woy~2015 Dirk Eichling wo =
Roche Diagnostics GmbH Roche Diagnostics GmbH Sandhofer Str. 116 Sandhofer Str. 116 68305 Mannheim 68305 Mannheim Germany Germany Roche Diagnistics GmbH Diagnostics Division
1 2 3 4 | CoverLetter TemporaryConfRequest | Cover Letter(s) | 180.84 KiB |
SHORT-TERM CONFIDENTIALITY REQUEST Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 26.Oct.2015 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, we requests short term confidentiality for the following product:
FCC ID Number Product Title/ Model VO9UUI8 CoaguChek Pro II For the product stated above, we request that the following information be held confidential:
L External and Internal Photographs 2. Test Setup Photos 3. User Manual We request this confidentiality on the basis of ensuring that business sensitive information remains confidential until the actual marketing of our new device, which is planned for 01.Mar.2016 If you have any questions, please feel free to contact me at the address shown below. Sincerely,
(signed) L-co4 Dol a -2od Cc Name: Dirk Eichling Co= 0 Company: Roche Diagnostics GmbH Address: Sandhofer Strasse 116, 68305 Mannheim, GERMANY Phone: +49 (621) 759 4794 Email: dirk.eichling@roche.com
1 2 3 4 | CoverLetter Authorization | Cover Letter(s) | 60.95 KiB | May 11 2015 / June 11 2015 |
Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Industry Canada Certification & Engineering Bureau 3701 Carling Ave. Bldg. 94 Ottawa, On K2H 882 August 4, 2015 TO WHOM IT MAY CONCERN FCC ID: VO9UU18, IC: 3100A-UU18 We the undersigned, hereby authorize Roche Diagnostics GmbH, Sandhofer Strasse 116, 68305 Mannheim Germany, to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters for the COBAS h232. Any and all acts carried out by Roche Diagnostics GmbH, on our behalf shall have the same effect as acts of our own. The authorization is valid for (expiry date): unlimited Gill 9 Meus Sincerely, Tony Heleine Principal R&D Engineer Roche Diabetes Care, Inc 9115 Hague Road Indianapolis, IN, USA 46060 Phone: (317) 521-3404
1 2 3 4 | CoverLetter ConfidentialityRequestLetter | Cover Letter(s) | 193.70 KiB | May 11 2015 / June 11 2015 |
CONFIDENTIALITY REQUEST for Certification Service in USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 09-Dec-2013 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b) (4) of the Freedom of Information Act, we requests confidentiality for the following products:
ECC ID Model name VO9UU18 HBM 4 ACCU-CHEK Inform II (02) / CoaguChek XS Pro / cobas h232 For the product stated above, we request permanent confidentiality for exhibits which contain Operational Description, Block Diagram, Schematics, Parts Lists or Tune Up Information. The above exhibits contain our trade secrets and proprietary information that could be of benefit to our competitors. If you have any questions, please feel free to contact me at the address shown below. Sincerely,
(signed) ZRH Ze Name: p.p. Dr. Andreas Staubert Company: ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM Address: 9115 Hague Road, 46250-0457 Indianapolis (IN), USA Phone: +1 (317) 521 2000 Fax: +1 (317) 521 2000 Email: Andreas.staubert@roche.com
1 2 3 4 | CoverLetter ShortTermConf | Cover Letter(s) | 179.72 KiB | May 11 2015 / June 11 2015 |
SHORT-TERM CONFIDENTIALITY REQUEST Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 27.Oct.2015 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, we requests short term confidentiality for the following product:
FCC ID Number Product Title/Model VO9UUI8 cobas h 232 For the product stated above, we request that the following information be held confidential:
1. External and Internal Photographs 2. Test Setup Photos 3. User Manual We request this confidentiality on the basis of ensuring that business sensitive information remains confidential until the actual marketing of our new device, which is planned for 29.Apr.2016 If you have any questions, please feel free to contact me at the address shown below. Sincerely, CAG Div 2-Nov- ZO Ay
(signed) Name: Dirk Eichling Company: Roche Diagnostics GmbH Address: Sandhofer Strasse 116, 68305 Mannheim, GERMANY Phone: +49 (621) 759 4794 Email: dirk.eichling@roche.com
1 2 3 4 | PCIIRequestLetter | Cover Letter(s) | 100.23 KiB |
Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Industry Canada Certification & Engineering Bureau 3701 Carling Ave. Bldg. 94 Ottawa, On K2H 882 16 December 2013 TO WHOM IT MAY CONCERN Request for Permissive Change Class II FCC ID: VOSUUIB8, IC:3100A-UU18 Pursuant to CFR 2.1043 and RSP-100, Roche Diagnostics, hereby requests a Permissive Change Class II for its application with FCC ID: VO9UU18 and IC ID: 3100A-UU18 granted on 12-Dec-2013 Reason:
- Portable host configuration: Accu-Chek Inform II (02)
- Portable host configuration: CoaguChek XS Pro Modifications:
- No hardware changes on module
- No modification in the module housing/shielding
- No changes in respect to module antenna Display, device specific measurement module, and button mounted on different spots on the module External housing will be added to host additional components (digital display, parameter specific measurement module, battery, barcode scanner) Device specific distinctions:
The module (FCC ID: VO9UUIB, IC: 3100A-UU18) will be used in 2 different configurations, to meet the arrangement of device specific (hereby host Accu-Chek Inform II (02) and host CoaguChek XS Pro) cable connections for further components (digital display and parameter specific measurement modules). The conducting paths are identical for each configuration of the module, but the mechanical ports are getting installed device specific. This will ensure, that the WLAN functionality will not be affected due to different configurations. The following new exhibits will be uploaded:
- RF Exposure Info
- Internal Photos
- External Photos a Sincerely,
(Signature) g 7 Name: p.p. Dr. Andreas Staubert p-p. Dr. L nbach Company: ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM Address: 9115 Hague Road, 46250-0457 Indianapolis (IN), USA Phone: +1 (317) 521 2000 Fax: +1 (317) 521 2000 Email: Andreas.staubert@roche.com 2/2
1 2 3 4 | ModularApprovalRequestLetter | Cover Letter(s) | 248.84 KiB | December 12 2013 |
RocheDiagnostics GmbH IC/FCC Modular Approval Statement Sandhofer Strasse 116 68305 Mannheim / Germany Receiver Federal Communication Commission Equipment Authorization Devision, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Industry Canada Spectrum Engineering Branch 3701 Carling Avenue, Building 94 Ottawa, Ontario K2H 8S2 Subject: Modular Approval Statement Date: 26-Nov-2013 IC Certification Number: 3100A-UU18 FCC Certification Number: VO9UU18 Model Name/Number: HBM 4 TO WHOM IT MAY CONCERN Pursuant to Paragraphs RSS-GEN Issue 3 December 2010 Item 3.2.2 and CFR 15.212, we herewith declare for our module. Modular approval requirement Yes No*
(a) The radio elements must have the radio frequency circuitry be shielded. Physical/discrete and tuning capacitors may be located external to the shield, but must be on the module assembly. yes
*Please provide a detailed explanation if the answer is No.:
(b) The module shail have buffered modulation/data input(s) (if such inputs are provided) to ensure that the module will comply with the requirements set out in the applicable RSS standard under conditions of excessive data rates or over-modulation. yes
*Please provide a detailed explanation if the answer is No.:
(c) The module shall have its own power supply regulation on the module. This is to ensure that the module will comply with the requirements set out in the applicable standard regardless of the design of the power supplying circuitry in the host device which houses the module.
*Please provide a detailed explanation if the answer is No.:
| yes
(d) The module shall comply with the provisions for external power amplifiers and antennas detailed in this standard. The equipment certification submission shall contain a detailed description of the configuration of all antennas that will yes be used with the module.
*Please provide a detailed explanation if the answer is No.:
(e) The module shall be tested for compliance with the applicable standard in a stand-alone configuration, ie. the module must not be inside another device yes during testing. RocheDiagnostics GmbH IC/FCC Modular Approval Statement Sandhofer Strasse 116 68305 Mannheim / Germany
*Please provide a detailed explanation if the answer is No.:
(f) The module shall comply with the Category | equipment labeling requirements and CFR 15.212(a)(1)(vi).
*Please provide a detailed explanation if the answer is No.:
ves |
(g) The module shall comply with applicable RSS-102 exposure requirements and any applicable FCC RF exposure requirement which are based on the
*Please provide a detailed explanation if the answer is No.:
yes intended use/configurations. LE Only applicable for IC certification:
h) Is the modular device for an Industry Canada licensed exempt service?
*Please provide a detailed explanation if the answer is No.:
Only applicable for FCC certification:
(i) The modular transmitter complies with all applicable FCC rules. Instructions for maintaining compliance are given in the user instructions.
| * 7 If you have any questions, please feel free to contact us at the address shown below Best Regards, Name: p.p. Dr. Andreas Staubert p.p. Dr. Ludger Bodenbach Company: ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM Address: 9115 Hague Road, 46250-0457 Indianapolis (IN), USA Phone: +1 (317) 521 2000 Fax: +1 (317) 521 2000 Email: Andreas.staubert@roche.com
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2015-11-23 | 2412 ~ 2462 | DTS - Digital Transmission System | Class II permissive change or modification of presently authorized equipment |
2 | 2015-11-06 | 2412 ~ 2462 | DTS - Digital Transmission System | |
3 | 2013-12-16 | 2412 ~ 2462 | DTS - Digital Transmission System | |
4 | 2013-12-12 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 4 | Effective |
2015-11-23
|
||||
1 2 3 4 |
2015-11-06
|
|||||
1 2 3 4 |
2013-12-16
|
|||||
1 2 3 4 |
2013-12-12
|
|||||
1 2 3 4 | Applicant's complete, legal business name |
Roche Diagnostics GmbH
|
||||
1 2 3 4 | FCC Registration Number (FRN) |
0016954943
|
||||
1 2 3 4 | Physical Address |
Sandhofer Strasse 116
|
||||
1 2 3 4 |
Mannheim, 68305
|
|||||
1 2 3 4 |
Germany
|
|||||
app s | TCB Information | |||||
1 2 3 4 | TCB Application Email Address |
O******@cetecom.com
|
||||
1 2 3 4 |
o******@cetecom.com
|
|||||
1 2 3 4 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 3 4 | Grantee Code |
VO9
|
||||
1 2 3 4 | Equipment Product Code |
UU18
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 4 | Name |
A******** R********
|
||||
1 2 3 4 | Title |
Dr
|
||||
1 2 3 4 | Telephone Number |
+49 6******** Extension:
|
||||
1 2 3 4 | Fax Number |
+49 6********
|
||||
1 2 3 4 |
a******@roche.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 3 4 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 4 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 4 | No | |||||
1 2 3 4 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 03/01/2016 | ||||
1 2 3 4 | 04/29/2016 | |||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 3 4 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 4 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 3 4 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood Coagulation Meter | ||||
1 2 3 4 | Medical Device with WLAN b/g | |||||
1 2 3 4 | HBM4 | |||||
1 2 3 4 | HBM 4 | |||||
1 2 3 4 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 4 | Modular Equipment Type | Does not apply | ||||
1 2 3 4 | Limited Single Modular Approval | |||||
1 2 3 4 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 3 4 | Original Equipment | |||||
1 2 3 4 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 3 4 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 3 4 | Grant Comments | PCII to allow portable host devices Limited Modular Approval. Power Output listed is conducted. This Module is approved for installation in devices under direct control of the Grantee The antenna(s) used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Installers must be provided with antenna installation and transmitter operating conditions for satisfying RF exposure compliance. The highest reported SAR is 0.16 W/kg. | ||||
1 2 3 4 | PCII to allow portable host devices Limited Modular Approval. Power Output listed is conducted. This Module is approved for installation in devices under direct control of the Grantee The antenna(s) used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Installers must be provided with antenna installation and transmitter operating conditions for satisfying RF exposure compliance. The highest reported SAR is 0.10 W/kg. | |||||
1 2 3 4 | Limited Modular Approval. Power Output listed is conducted. This Module is approved for installation in devices under direct control of the Grantee. The antenna(s) used for this transmitter must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Installers must be provided with antenna installation and transmitter operating conditions for satisfying RF exposure compliance. | |||||
1 2 3 4 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 4 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 4 | Firm Name |
CTC advanced GmbH (former CETECOM ICT Services )
|
||||
1 2 3 4 | Name |
G******** S****
|
||||
1 2 3 4 | Telephone Number |
49-68********
|
||||
1 2 3 4 | Fax Number |
49-68********
|
||||
1 2 3 4 |
t******@ctcadvanced.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0590000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0590000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0590000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
4 | 1 | 15C | 2412.00000000 | 2462.00000000 | 0.0590000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC