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2.911(d)(7) Attestation Letter | Attestation Statements | 281.13 KiB | December 11 2023 | |||
1 2 | Antenna information | Operational Description | December 11 2023 | confidential | ||||
1 2 | Block Diagram | Block Diagram | December 11 2023 | confidential | ||||
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FCC Confidentiality Request | Cover Letter(s) | 998.61 KiB | December 11 2023 | |||
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SAR Test Report | RF Exposure Info | 1.85 MiB | December 11 2023 | |||
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SAR Test Setup Photos | RF Exposure Info | 933.07 KiB | December 11 2023 | |||
1 2 | Schematics | Schematics | December 11 2023 | confidential | ||||
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1 2 | Users Manual | Users Manual | 2.18 MiB | December 11 2023 |
This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use. Diese Kopie wird nicht aktualisiert. berprfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE Ansprechpartner. Esta copia no va a ser actualizada. Verifique el status de esta versin en DiaDoc o contacte a su representante de ROCHE antes de utilizarla. Document Information:
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Wallace, Barbara {DSSD~Mannheim}
Global Platforms & Support Confidential Device Master Record Device Master Record Wallace, Barbara {DSSD~Mannheim}
Signed 24-Jan-2023 09:31:11 (UTC) cobas_h232_OM_v7_07469101001_04_EN 0000000000001200000160397 05 No Product Documentation Operators Manual English Mannheim Global Customer Support cobas_h232_OM_V7_07469101001-04_EN 07469101001 Additional change page 199. Roche CARDIAC M Myoglobin and Roche CARDIAC CK-MB REF number changed from XXX to 190. Updated for SW04.03; Biohazard Symbol added to meter housing; added Information About Roche CARDIAC Pipettes Electronic Signatures:
Signed By:
Role:
Signature Differentiation:
Signed Date:
wallacb5 (Barbara Wallace {DSSDPA}) Approver Documentation Management 24-Jan-2023 09:16:01 (UTC) Signed By:
Role:
Signature Differentiation:
Signed Date:
galinkig (Galina Galinkina {DSPCA}) Approver International Product Manager - IPM 20-Jan-2023 15:49:22 (UTC) Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Print Date:
Print Comment:
Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Cover Page 1 (1) cobas h 232 Operators Manual Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 1 (228) 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 2016-06 Version 6.0 2016-06 Version 6.1 2021-11 Version 7.0 2022-11 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: updated meter housing; 2D barcode scanner; wireless LAN option; new battery pack. Update to SW 04.00. Update of cleaning and disinfection section; added safety information on battery packs; deleted appendix for addresses; misc. editorial revisions. Updated safety information, added information on TnT Elevated message, minor editorial revisions. Implementation of supplements for SW features for SW 04.01 and SW 04.02 and implementation of IVDR-related requirements
(IVDR: in vitro diagnostics regulation). Biohazard symbol added to meter housing;
Update to SW 04.03; Status communication indicator icon; TLS authentication; TLS setup;
Data Deletion; Meter credential download;
added information about Roche CARDIAC Pipettes. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 2 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 2 (228) cobas h 232 Operators Manual Version 7.0 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 3 (228) 0 7469101001 (04) 2022-11 EN 2006-2022, 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. Electronic user documentation can be downloaded using the eLabDoc e-service on Dialog:
www.dialog.roche.com/
For more information, contact your local affiliate or Roche Service 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 4 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 4 (228) 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 Date of manufacture Batch code/ Lot number Catalogue number Global Trade Item Number Unique device identifier Serial Number In vitro diagnostic medical device Device for near-patient testing Device not for self-testing Biohazardous Complies with the provisions of the applicable EU regulations. The cobas h 232 meter meets the requirements laid down in:
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonization of the laws of the Member States relating to the making avail-
able on the market of radio equipment and repealing Directive 1999/5/EC. Directive 2011/65/EU (including 2015/863) of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment. The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accord-
ance with UL 61010A-1:02 and CAN/CSA-C22.2 No. 61010-1-04). Eurasian Conformity. Demonstrates that the product meets the Eurasian Economic Union (EAEU)s regulations and standards for customs clearance and trading. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 5 (228) 5 cobas h 232 meter Power adapter Manual CONTENT Content 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 6 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 6 (228) What is new in publication version 7.0?
Amendments Information about Roche CARDIAC Pipettes added, see page 36. SW 04.03 TLS authentication, see page 72. TLS and communication status icons, see page 35. Battery fill state during charging, see page 34. Improved functions for automatic data deletion, see page 79. Certificate handling, see page 88. Downloading meter credentials, see page 93. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 7 (228) 7 This page intentionally left blank. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 8 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 8 (228) Table of Contents 1 2 3 Introduction What is new in publication version 7.0?
7 Amendments........................................................................................................................................ 7 SW 04.03................................................................................................................................................ 7 13 Intended Use...................................................................................................................................... 13 Summary.............................................................................................................................................. 13 Test principle ..................................................................................................................................... 15 Contents of the pack ...................................................................................................................... 15 1.1 Important safety instructions and additional information......................................................... 16 Safety information ........................................................................................................................... 17 Disposal of the system .................................................................................................................. 19 Battery pack ....................................................................................................................................... 19 General care....................................................................................................................................... 21 Electrical safety ................................................................................................................................ 21 Electromagnetic interference ...................................................................................................... 22 Touchscreen....................................................................................................................................... 22 Local Area Network: protection from unauthorized access ............................................ 22 Wireless connectivity ...................................................................................................................... 24 Radiofrequency radiation exposure information.................................................................. 24 1.2 Overview of the meter and its accessories..................................................................................... 26 Meter ................................................................................................................................................... 26 Power adapter ................................................................................................................................... 29 Test strip .............................................................................................................................................. 31 Handheld Base Unit ........................................................................................................................ 32 1.3 Overview of the Buttons and Icons used on Screen................................................................... 33 1.4 Roche CARDIAC Pipettes ..................................................................................................................... 36 Intended use ...................................................................................................................................... 36 Handling .............................................................................................................................................. 36 Precautions and Warnings ........................................................................................................... 36 37 2.1 Installing or replacing the battery pack........................................................................................... 38 Removing the battery pack .......................................................................................................... 39 Installing the battery pack ............................................................................................................ 40 Powering the meter on and off ................................................................................................... 43 Shut down / restart meter............................................................................................................. 44 Automatic shutdown....................................................................................................................... 44 45 Settings summary............................................................................................................................. 46 3.1 Basics setup ............................................................................................................................................... 52 Contrast ............................................................................................................................................... 52 Language ............................................................................................................................................ 54 Setting the date................................................................................................................................. 56 Setting the time................................................................................................................................. 58 Setting the display options for date and time ....................................................................... 60 Sound.................................................................................................................................................... 62 Auto off ................................................................................................................................................ 65 Putting the Meter into Operation Meter Setup Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 9 (228) 9 Table of Contents 3.2 Data Handling setup................................................................................................................................ 67 Connection ........................................................................................................................................ 67 QR Code............................................................................................................................................... 68 Computer............................................................................................................................................. 71 TLS menu ............................................................................................................................................ 72 Printer ................................................................................................................................................... 73 Result memory................................................................................................................................... 75 Result units ......................................................................................................................................... 81 Result display mode ........................................................................................................................ 84 Diagnostics ......................................................................................................................................... 86 3.3 Certificates setup...................................................................................................................................... 88 Certificate status symbols ............................................................................................................. 89 Managing the client certificate................................................................................................... 90 Managing server certificates ....................................................................................................... 91 Managing Root CA certificates................................................................................................... 92 Downloading credentials............................................................................................................... 93 3.4 ID Setup setting ........................................................................................................................................ 94 Administrator ID ............................................................................................................................... 95 Operator ID...................................................................................................................................... 101 Patient ID.......................................................................................................................................... 105 3.5 Lockout setup ......................................................................................................................................... 108 Operator lockout............................................................................................................................ 109 Quality control (QC) settings .................................................................................................... 112 Quality control (QC) lockout ..................................................................................................... 114 Instrument quality control (IQC) lockout.............................................................................. 116 QC result format ............................................................................................................................ 117 Custom Range................................................................................................................................ 118 Reset test parameters.................................................................................................................. 120 Cleaning lockout............................................................................................................................ 121 STAT test configuration .............................................................................................................. 122 3.6 Optional Screens setup ....................................................................................................................... 124 127 Sample material ............................................................................................................................ 129 4.1 Preparing to test .................................................................................................................................... 129 Code chip ......................................................................................................................................... 130 Inserting the code chip .............................................................................................................. 131 Test steps (overview) ................................................................................................................... 132 Powering on the meter................................................................................................................ 134 Logging in ........................................................................................................................................ 135 4.2 Performing a test ................................................................................................................................... 139 Inserting a test strip .................................................................................................................... 143 Displaying, confirming or adding comments to results.................................................. 149 Displaying the test result as QR code ................................................................................... 152 STAT tests ........................................................................................................................................ 153 155 5.1 Preparing to run a quality control test .......................................................................................... 157 5.2 Performing a quality control test ..................................................................................................... 158 Quality control (QC) ..................................................................................................................... 158 Instrument quality control (IQC).............................................................................................. 166 Control Testing and Quality Control Performing a Test 4 5 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 10 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 10 (228) Table of Contents 6 7 8 9 10 11 A Review Results Maintenance and Care Extended Functionalities 169 Reviewing test results.................................................................................................................. 169 Patient history................................................................................................................................. 171 All results.......................................................................................................................................... 172 Quality control (QC) results....................................................................................................... 173 Instrument quality control (IQC) results ............................................................................... 174 Maintenance history .................................................................................................................... 175 177 Data handling ................................................................................................................................. 177 Computer (Setup option) ........................................................................................................... 178 Software updates ......................................................................................................................... 178 Operator lists................................................................................................................................... 179 Patient lists ...................................................................................................................................... 180 Barcode scanner ........................................................................................................................... 181 Stored test results and comments.......................................................................................... 181 183 8.1 Conditions for storage and shipping ............................................................................................. 183 Storage.............................................................................................................................................. 183 Shipping............................................................................................................................................ 184 8.2 Cleaning and disinfecting the meter ............................................................................................. 185 Difference between cleaning and disinfecting.................................................................. 185 When should the meter be cleaned and disinfected? .................................................... 185 What to clean and disinfect? .................................................................................................... 185 Recommended cleaning/disinfecting agents..................................................................... 187 Cleaning after contamination due to mispipetting........................................................... 188 Cleaning the meter ....................................................................................................................... 189 Disinfecting the meter................................................................................................................. 191 193 Errors and unusual behavior without error messages .................................................... 194 Meter reset ...................................................................................................................................... 196 197 10.1 Operating conditions and technical data..................................................................................... 197 Technical data ................................................................................................................................ 197 Sample material ............................................................................................................................. 198 Storage conditions........................................................................................................................ 198 Transport conditions .................................................................................................................... 198 10.2 Further information............................................................................................................................... 198 List of available assays, accessories and consumables ................................................. 198 Product limitations........................................................................................................................ 201 Information about software licenses .................................................................................... 201 Repairs .............................................................................................................................................. 201 201 203 A.1 Working with barcodes....................................................................................................................... 203 A.2 Operator and patient ID barcode masks...................................................................................... 204 A.3 Example of barcode symbologies ................................................................................................... 205 A.4 Supported characters in 2D barcodes .......................................................................................... 207 General Product Specifications Warranty Appendix Troubleshooting Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 11 (228) 11 Table of Contents B C D Appendix 209 B.1 Option: Wireless network (WLAN).................................................................................................. 209 Preliminary note............................................................................................................................. 209 Background ..................................................................................................................................... 209 Technical implementation.......................................................................................................... 210 RF specific functionalities and effective performance claims...................................... 212 215 Observed Test Sequence (OTS) .............................................................................................. 215 Using the OTS function............................................................................................................... 216 219 221 Supplement for Observed Test Sequence Contact Roche Index Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 12 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 12 (228) Introduction 1 Introduction Intended Use The cobas h 232 is an in vitro diagnostic instrument intended for the quantitative evaluation of immunoassays using the Roche CARDIAC test strips in human whole blood. The cobas h 232 is intended for near-patient testing. Not for self-testing. Summary 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 associated 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. Data management systems may have the abil-
ity to expand the security features of the meter, such as enabling operator lockouts. Data man-
agement systems may also enable data transfer to a hospital information system (HIS) or to a laboratory information system (LIS). Refer to the manuals of the Handheld Base Unit and of your DMS for technical details. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 13 (228) 13 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 219). 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 14 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 14 (228) 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 Battery compartment cover Torx screw driver for mounting the battery compartment cover Operators Manual Quick Reference Guide 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 15 (228) 15 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 16 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 16 (228) Safety information Introduction WARNING WARNING 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. Incident reporting Inform your Roche representative and your local competent authority about any serious incidents which may occur when using this product. QC and IQC Lockouts QC and IQC lockouts are disabled by default. For routine confirmation of system reliability it is strongly recommended to enable this feature. See QC recommendations on page 156. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 17 (228) 17 Introduction CAUTION WARNING Allergy or injury caused by reagents and other working solutions Direct contact with reagents, detergents, cleaning/disinfection solutions, or other working solutions may cause skin irritation or inflammation. 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 adapters, battery packs, and spare parts). Third-party cables, power adapters, 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 adapters, cables, plugs, or battery packs. Do not short circuit the power adapter, the handheld base unit con-
tacts, or the battery pack. Do not drop the cobas h 232 meter, the power adapter, or the battery pack and protect these against shaking and vibrations. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 18 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 18 (228) Disposal of the system Introduction 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. For more information, contact your Roche representative. WARNING Battery pack The meter contains a rechargeable battery pack that can be charged if the power adapter is con-
nected or the meter is placed on an active Handheld Base Unit (i.e., one connected to a power adapter). The charging process starts as soon as the meter goes into standby mode. NOTICE Use only the specially designed battery pack provided by Roche Diagnostics. Using any other type of battery may damage the system. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 19 (228) 19 Introduction WARNING Possible hazards posed by the lithium-ion battery pack Damaged or swollen lithium-ion (Li-ion) battery packs can overheat, catch fire, or leak. Immediately cease use of cobas h 232 meters with damaged or swollen Li-ion battery packs. Under no circumstances recharge meters with damaged or swollen Li-ion battery packs by placing them in the handheld base unit or connecting them to the power adapter. Overheating can cause the battery pack to catch fire or explode. Never throw the battery pack or the meters onto a fire. Do not 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 20 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 20 (228) 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 187). 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 21 (228) 21 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 net-
work or the Internet. Customers are responsible for the security of their local area net-
work, especially in protecting it against malicious software and attacks. This protection might include measures, such as a firewall, to separate the device from uncontrolled net-
works as well as measures that ensure that the connected network 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 environment, use a strong password for user or operator accounts on the meter, DMS, and network. Observe your own facility guidelines on password management where available, or apply the rules for strong passwords, see Characteristics of strong passwords below. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 22 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 22 (228) Introduction 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 197. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 23 (228) 23 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 24 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 24 (228) 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 25 (228) 25 Introduction 1.2 Overview of the meter and its accessories Meter B A C D E A Touchscreen D Test strip guide cover Shows results, information, icons and results saved in the memory. To select an option, simply touch the button lightly. Remove this cover to clean the area underneath (if it has become soiled, e.g., with blood). B On/Off button E Barcode scanner Press this button to power the meter on or off. C Opening for sample application Opening in the test strip guide cover that enables you to apply blood once the test strip is inserted. Operator and patient IDs can be read into the meter using the integrated barcode scanner. *
* To determine if your meter has this function compare the REF number on the meter identifica-
tion plate to the corresponding ordering information (list of REF numbers) on page 200. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 26 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 26 (228) Introduction F G I H N F Battery compartment cover H Wireless LAN label Remove to insert the battery pack. G Meter identification plate See page 5 for symbol explanation. If the meter supports wireless connectivity:
This label displays registration numbers that are specific to the meter RF hard-
ware. *
* To determine if your meter has this function compare the REF number on the meter identifica-
tion plate to the corresponding ordering information (list of REF numbers) on page 200. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 27 (228) 27 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 28 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 28 (228) Introduction Power adapter N O N Universal 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 can 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 settings, even when no battery pack is inserted. In general, it is not recommended to detach the external power adapter or undock the meter from the Handheld Base Unit during a measurement. When the meter is connected to an external power adapter and the battery level is low, measurements cannot be completed if the external power adapter is detached. In this case a message is displayed not to remove the external power adapter. To save power, the meter can automatically power itself off or go into standby mode, 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 65). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 29 (228) 29 Introduction Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 04/19/2023 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 19. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 30 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 30 (228) Test strip Introduction R P Q S P Test area R Barcode 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. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 31 (228) 31 Introduction Handheld Base Unit U T V Y X W Z T Charging contacts Used for power adapter and/or charging the battery pack. X Data ports (Ethernet/RJ45 and USB) For connecting the device to a Data Management System (DMS). U Status indicator Y Connection socket for the 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, optional. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 32 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 32 (228) 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 193. 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) Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 33 (228) 33 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 Individual segments appear one by one as the battery pack is charged If the battery pack is fully charged, all segments are lit Time between midnight and noon (in 12-hour time format) Time between noon and midnight (in 12-hour time format) am pm 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 34 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 34 (228) The following icons may appear when using the meter in conjunction with a data management system (DMS). Introduction Infrared interface is enabled (for communication with the computer and/or printer) Infrared interface is enabled, the last attempt to communicate with the data management system was successful and terminated according to the communication protocol Infrared interface is enabled, the last attempt to communicate with the data management system was not successful or was unintentionally terminated. If this icon persists, contact your system administrator. Communication is taking place via WLAN Communication is taking place via WLAN, the last attempt to commu-
nicate with the data management system was successful and termi-
nated according to the communication protocol Communication is taking place via WLAN, the last attempt to commu-
nicate with the data management system was not successful or was unintentionally terminated. If this icon persists, contact your system administrator. The last communication with the data management system was nei-
ther TLS encrypted nor TLS authenticated The last communication with the data management system was TLS encrypted, but not TLS authenticated. The last communication with the data management system was both TLS encrypted and TLS authenticated. An OTS request is pending Cleaning/Disinfection necessary The communication security icon communication with the data management system. The icon is shown permanently after the initial communication of a brand new meter has taken place. indicates the security status of current or last Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 35 (228) 35 Introduction 1.4 Roche CARDIAC Pipettes Intended use The Roche CARDIAC Pipettes are intended only for drawing the sample from the blood collection tube and application of the sample onto the Roche CARDIAC test strips. The Roche CARDIAC Pipettes are intended for near-patient testing. Not for self-testing. Handling Remove the protective caps and use the Roche CARDIAC Pipettes to draw exactly 150 L (to the blue mark on the pipette) heparinized blood from the blood collection tube. Precautions and Warnings Before use, visually check if the packaging of the Cardiac pipettes and/or the pipettes are intact. If the needle falls off or gets stuck during use, do not try to re-cap it. Stop using the pipette immediately and dispose of it in a sturdy sharps container (in accordance with applicable local regulations and directives and your facilitys guidelines). Never use Roche CARDIAC Pipettes for blood sampling directly from the vein nor for administer-
ing 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 36 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 36 (228) 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 40). 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 45). 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 37 (228) 37 Putting the Meter into Operation 2.1 Installing or replacing the battery pack When shipped, the battery pack is not installed in the meter. When the battery pack is not installed, the meter cannot be used. 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 at least 4 hours before testing, preferably overnight. 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 available and the meter can be charged if necessary. Charging starts automatically after 10 minutes when switching into standby mode. To start the charging process immediately put the meter into standby mode by pressing the On/Off button for approximately 1 second. The meter will only charge while in standby mode. The meter will not continue to charge when woken up from standby mode. 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. Replace the battery pack within approximately 24 hours to retain the date and time settings. Beyond this period of time, you may have to re-enter date and time. Replace the battery pack only in shutdown mode, see page 44. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 38 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 38 (228) Removing the battery pack Putting the Meter into Operation 1 If a battery pack is already installed, make sure that the meter is shut down to pre-
vent damage to the meter or potential data loss (see page 44). Always disconnect the external power adapter before removing the battery pack. 2 Place the meter face down on a level sur-
face. 3 Use the starshaped Torx screw driver
(delivered with the cobas h 232 product pack/kit) to remove the four screws hold-
ing 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 39 (228) 39 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). Always disconnect the external power adapter before inserting the battery connector plug. 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. Preferably use the battery pack that was shipped with the meter. When the battery pack is installed, the meter checks if battery pack and meter are compatible. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 40 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 40 (228) 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 41 (228) 41 Putting the Meter into Operation After inserting a new battery pack, the meter should be charged overnight before testing. The meter powers on automatically and the Roche logo is displayed. If the meter does not start up automatically, the battery pack may be empty. In this case either a red battery symbol or a charging symbol is displayed. When the battery pack is charged sufficiently, the meter starts up automatically. 7 If the meter has been without power for too long, you have to re-enter the date and time settings. After you have entered the correct information, confirm each screen with
. Set Date 2023 Year:
Month:
1 Day:
1 Hour:
Set Time 3 Minutes:
49 04/19/2023 AM PM 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 42 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 42 (228) Powering the meter on and off Putting the Meter into Operation 1 Power the meter on by pressing the button. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 43 (228) 43 Putting the Meter into Operation Shut down / restart meter Shutting down the meter shuts down wireless communication and all other functionalities. Date and time, however, are maintained. 1 Device is not connected to the external power adapter or HBU:
To shut down the meter, press the button for about 5 seconds and release the button as soon as the Roche logo is displayed and the meter beeps. The screen goes blank and the meter is shut down. Use meter shutdown when you want to remove or replace the battery pack (see page 36). 2 Device is connected to the external power adapter or HBU:
button for about 5 seconds and release the button as soon as To restart the meter, press the the Roche logo is displayed and the meter beeps. The screen goes blank and the meter powers itself off and on. Use meter restart if the meter does not respond to user actions (like touching buttons). If you press the
(see page 196) and date and time will be lost. button for too long, a meter reset will be triggered after about 12 seconds Automatic shutdown If the battery pack is critically low, the meter willl shut down automatically. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 44 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 44 (228) 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 33. 04/19/2023 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 45 (228) 45 Meter Setup Settings summary The diagram below gives an overview of the setup areas that can be accessed on the meter. Setup Basics Data Handling Contrast Language Date/Time Sound Auto Off Connection Result Memory Result Units Result Display Mode Diagnostics ID Setup Lockout Optional Screens Administrator ID Operator ID Patient ID Operator Lockout QC Settings Cleaning Lockout STAT Test Con g. Start Info Result Login Result Con rmation Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 46 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 46 (228) Group Basics Setting Subgroup Contrast Language Meter Setup Values *
0 10 (5*) Dansk Deutsch English *
Espaol Franais Italiano Nederlands Norsk Portugus Svenska Date/Time Date Time An installable language 01/01/2011 *
12:00 am *
Date formats Day.Month.Year (31.12.2011) Month/Day/Year (12/31/2011) *
Year-Month-Day (2011-12-31) Time formats 24-hour time format (24H) 12-hour time format (12H), with am/pm *
Sound (Beeper) Volume Key Click Off Low Medium *
High Enable Disable *
Auto Off
[minutes]
Off 1 10 (default: 5 min *) 15, 20, 25, 30 40, 50, 60
* Default settings are labelled with an asterisk (*). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 47 (228) 47 Meter Setup Group Data Handling Subgroup Connection Setting Values *
QR Code Off *
Computer and TLS setup Printer Result Memory Result Display Filter All results *
Result Storage Mode Current Op. Res. No results deletion *
Delete oldest result Result Retention On, Off* & Value (30*) Delete Database Selection of Results, Code Chip Data or Entire Database Result Units Select DD Res. Unit g/mL *
ng/mL mg/L g/L Select TT Res. Unit ng/L *
Result Display Mode Diagnostics Software Error History Wireless Setup pg/mL ng/mL g/L Static *
Flashing Display of existing settings, parameters, and information only Certificates, Client Display and Renewal Certificates, Server Certificates, Root CA Credential Download Display, Approval and Deletion Display and Deletion Download of meter credentials
* Default settings are labelled with an asterisk (*). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 48 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 48 (228) Meter Setup Group ID Setup Subgroup Administrator ID Operator ID Setting Values *
Blank (off) *
(with DMS and list available on meter) None *
List
(No list available on meter) Patient ID Hidden List None *
Optional Required Scan Only None Optional *
Required Hidden List
* Default settings are labelled with an asterisk (*). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 49 (228) 49 Meter Setup Group Lockout Subgroup Operator Lockout (only if Operator ID option is enabled) Setting Values *
No *
Daily Weekly Monthly Every 3 months Every 6 months Yearly QC Settings QC Lockout New Lot: Yes/No *
IQC Lockout No *
Daily Weekly Monthly No *
Daily Weekly Monthly QC Result Format Pass/Fail *
Custom Range Trop T Value Value & Pass/Fail Default Range*
Custom Range Reset Test Param. Do Reset No Reset *
No *
Daily Weekly Monthly Enable Disable *
Cleaning Lockout STAT Test Config.
* Default settings are labelled with an asterisk (*). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 50 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 50 (228) 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 *
Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 51 (228) 51 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Basics Contrast Language Date/Time Sound Auto Off 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 52 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 52 (228) Meter Setup 4 Touch or a range from 0 to 10. to change the contrast in Select Contrast Contrast:
(0-10) 5 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 53 (228) 53 Meter Setup Language Use this setting to select the language for all displays (that contain text). Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 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 Setup - Basics Contrast Language Date/Time Sound Auto Off 04/19/2023 An optional language can be installed upon request (either directly at the plant or later by an authorised Roche Diagnostics service technician). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 54 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 54 (228) Meter Setup 4 Touch or of choice on the screen. to display the language Select Language Franais Italiano Nederlands Norsk Portugus 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 55 (228) 55 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. Meter Setup 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Basics Contrast Language Date/Time Sound Auto Off 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 56 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 56 (228) Setup - Date/Time Date Time Date/Time Format 04/19/2023 Set Date 2023 1 1 Year:
Month:
Day:
04/19/2023 Meter Setup 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 57 (228) 57 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. Meter Setup 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Basics Contrast Language Date/Time Sound Auto Off 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 58 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 58 (228) Setup - Date/Time Date Time Date/Time Format Set Time 3 Hour:
Minutes:
49 04/19/2023 AM PM 04/19/2023 Meter Setup 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 59 (228) 59 Meter Setup Setting the display options for date and time Select your preferred format for the date and time display. 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2023 Contrast Language Date/Time Sound Auto Off 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 60 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 60 (228) Setup - Date/Time Date Time Date/Time Format 04/19/2023 Select Date Format Date DD.MM.YYYY MM/DD/YYYY YYYY-MM-DD Time 24H 12H 04/19/2023 Meter Setup 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 61 (228) 61 Meter Setup 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:
it is powered on it detects a test strip pre-heating of the test strip is complete and you need to apply a sample it detects a blood 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) a test result requires operator confirmation and the meter will soon power off automati-
cally (three short beeps) 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 62 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 62 (228) 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 Sound. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2023 Contrast Language Date/Time Sound Auto Off 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 63 (228) 63 Meter Setup Setup - Sound Volume Key Click 04/19/2023 Select Volume Off Low Medium High 04/19/2023 Key Click Enable Disable 04/19/2023 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 64 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 64 (228) 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 time of usage before having to recharge the battery pack. Meter Setup 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - Basics 04/19/2023 Contrast Language Date/Time Sound Auto Off 04/19/2023 If connected to the power adapter or the Handheld Base Unit, the meter goes into standby mode instead of powering off if it has not been used for 10 minutes. Furthermore the meter can perform a maintenance reboot on a regular basis. The latter will only occur during meter inactivity. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 65 (228) 65 Meter Setup Set Auto Off Time Minutes:
5 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 66 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 66 (228) 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Data Handling Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 67 (228) 67 Meter Setup QR Code Select Connection 4 From the Select Connection menu, touch QR Code QR Code QR Code. Off Computer Printer 04/19/2023 Show QR code:
On Off Plain Text Coded Data URL Transmission 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 68 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 68 (228) 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. QR Code Show QR code:
On Off Plain Text Coded Data URL Transmission 04/19/2023 URL Transmission URL Encryption Key 04/19/2023 URL C H M R W
E J O T Y D I N S X 123 A F K P U Z B G L Q V
. 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 Touch menu. to open the URL Transmission 8 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 123 to switch to input of numbers. ABC to switch back to input of text. to backspace and correct a mistake. 9 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 69 (228) 69 Meter Setup URL Transmission URL Encryption Key Encryption Key Key:
JD5G29F6U8V2WC4L Serial No.:
KQ0327832 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. 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. 04/19/2023 Key 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 70 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 70 (228) 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. Select Connection QR Code Off Computer Printer 04/19/2023 13 From the Select Connection menu, touch Computer. Your selection is now high-
lighted. 14 Touch to save this setting and proceed to the TLS menu (see page 72), or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 71 (228) 71 Meter Setup TLS menu This menu allows you to configure the TLS Communication between meter and DMS. TLS TLS Encryption:
On Off TLS Authentication:
On Off 04/19/2023 15 Touch the desired configuration. TLS Encryption On: activates an end-to-end TLS tunnel from the meter to the DMS Off: the communication is not encrypted and no TLS authentication is possible TLS Authentication On: ensures the end-to-end TLS tunnel is only initiated between an authenticated meter and an authenticated DMS Off: TLS authentication is deactivated 16 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the Setup - Data Handling menu. Extended data handling functionality is dependent on the capabilities of the particular Data Management System (DMS) being used and may vary. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 72 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 72 (228) 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). Select Connection QR Code Off Computer Printer Select Printer Citizen CMP-10 GeBE GPT-437x Zebra MZ320 04/19/2023 04/19/2023 17 From the Select Connection menu, touch Printer. Your selection is now high-
lighted. 18 Touch to confirm the selection. The next screen allows you to choose the type of printer you are using. 19 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the Setup-Data Handling menu. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 73 (228) 73 Meter Setup Pat:
Op:
Par:
Pat. Test - Result PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 10:17 620 pg/mL 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 74 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 74 (228) Meter Setup Result memory Result memory settings allow to apply a Result Display Filter and to set the Result Storage Mode
(see page 77), and to delete stored test results, code chip data or the entire database (see page 80). 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Data Handling Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 75 (228) 75 Meter Setup Setup - Memory Result Display Filter Result Storage Mode Sel. Res. Display Filter 4 From the Setup-Memory menu, touch Result Display Filter to select the results to display. Result Retention Delete Database 04/19/2023 All Results Current Op. Res. The current setting is highlighted (white type on a blue background). You may select from the following options:
04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 76 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 76 (228) 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 177. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 77 (228) 77 Meter Setup Setup - Memory Result Display Filter Result Storage Mode Sel. Res. Storage Mode 7 From the Setup-Memory menu, touch Result Storage Mode to select your storage mode. Result Retention Delete Database 04/19/2023 No Result Deletion You may select from the following options:
Del. Oldest Result No Result Deletion Del(ete) Oldest Result 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 78 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 78 (228) Setup - Memory Result Display Filter Result Storage Mode Set Result Retention Result Retention Delete Database Delete results automatically:
On Off 04/19/2023 Retention time in days:
30 04/19/2023 Meter Setup 10 From the Setup-Memory menu, touch Result Retention to configure automatic deletion and setting a retention time. Touch the desired configuration:
Delete patient and QC results automati-
cally (On/Off) On: Results will be deleted automatically after the set retention time has elapsed. Off: Results will not be deleted automati-
cally based on a time interval. (Automatic deletion as per the Sel. Res. Storage Mode setting will still be performed.) 11 If automatic deletion is enabled, set the Retention time in days (11000), after which the automatic deletion will be per-
formed. 12 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. 13 Touch to return to the Setup-Data Handling menu. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 79 (228) 79 Meter Setup Setup - Memory Result Display Filter Result Storage Mode Result Retention Delete Database 04/19/2023 Con rm Deletion 14 From the Setup-Memory menu, touch Delete Database to delete stored test results, code chips or the complete data-
base (including operators, patients, code chips, test results and comments). 15 From the Delete Database menu, touch either Results, Code Chip Data or Entire Database, depending on the type of data you want to delete. to delete the selected data, or to exit this screen without delet-
16 Touch touch ing any data. The display automatically returns to the previous screen. 17 Touch to return to the Setup-Data Delete Database Results Code Chip Data Entire Database Do you really want to delete all results?
04/19/2023 Handling menu. Con rm Deletion Do you really want to delete all code chip data?
Con rm Deletion 04/19/2023 Do you really want to delete the entire database?
04/19/2023 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 80 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 80 (228) 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Data Handling Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 81 (228) 81 Meter Setup Setup - Result Units DD Result Units TT Result Units 04/19/2023 Select DD Res. Unit g/mL ng/mL mg/L g/L 04/19/2023 4 From the Setup-Result Units menu, touch DD Result Units. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 82 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 82 (228) Setup - Result Units DD Result Units TT Result Units 04/19/2023 Select TT Res. Unit ng/L pg/mL ng/mL g/L 04/19/2023 Meter Setup 7 From the Setup-Result Units menu, touch TT Result Units. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 83 (228) 83 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Data Handling Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 84 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 84 (228) Select Res. Display Mode Static Flashing 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 85 (228) 85 Meter Setup Diagnostics Under Diagnostics, you will find information about the system, such as software version and wireless configuration details. The Diagnostics menu contains functions relevant 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Data Handling Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 86 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 86 (228) Meter Setup Diagnostics Software Error History Certi cates Wireless Setup 04/19/2023 Wireless Setup Wireless Setup - Network Use DHCP:
Use DNS:
SSID:
WLAN:
MAC:
Enabled Disabled cobas h 232 01 23 45 67 89 AB Software 4 From the Diagnostics menu, touch the button of the diagnostics screen you want to display. See chapter 3.3 Certificates setup for detailed information about the Certifi-
cates menu. 5 Use and to toggle between the Wireless Setup screens. 6 In either diagnostics screen, touch return to the Diagnostics menu. to Note: The Wireless Setup button is only available if the meter is equipped with WLAN functionality. Build:
Boot:
Kernel:
RootFS:
App:
MM-BL:
MM-FW:
04.00.00 06.03.00 06.03.00 06.03.00 04.00.00 03.00.00 03.00.00 04/19/2023 Error History b360401c - 205 03/12/23 08:30 b360401c - 205 02/10/23 08:00 b5804001 - 302 01/02/23 10:17 b5804001 - 302 11/14/22 07:30 b360401c - 205 10/10/22 07:05 04/19/2023 Wireless Setup Wireless Setup - Connection DMS Name:
04/19/2023 DMS Port Number:
DMS IP Address:
RF Security:
POCTServer 4711 0.0.0.0 WPA2-PSK (AES) 04/19/2023 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 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 87 (228) 87 Meter Setup 3.3 Certificates setup Use the Certificates menu to manage the required certificates for TLS communication between meter and the DMS:
renew the client certificate activate or delete server certificates delete Root CAs TLS (Transport Layer Security) supports many different methods for exchanging keys, encrypting data and authenticating message integrity. Using the TLS encryption and authen-
tication provides an end-to-end TLS tunnel from meter to DMS. Activate these options as the most effective measure to ensure secure communication. 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - Data Handling Connection Result Memory Result Units Result Display Mode Diagnostics 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 88 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 88 (228) Meter Setup Diagnostics Software Error History Certi cates Wireless Setup Certi cates Client Certi cate Server Certi cates Root CA Certi cates Credential Download 4 From the Diagnostics menu, touch Certificates to display the Certificates menu. 5 In either diagnostics screen, touch return to the Diagnostics menu. to 04/19/2023 04/19/2023 Certificate status symbols In any of the certificate screens described below (Client, Server, Root CA) the status of a certifi-
cate is indicated by the following symbols:
Indicates that the server or root CA certificate status is approved. Indicates that the server certificate status is not approved. Indicates that the server or root CA certificate is expired. Download; for downloading credentials. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 89 (228) 89 Meter Setup Managing the client certificate You can display and renew the client certificate. Certi cates Client Certi cate Server Certi cates Root CA Certi cates Credential Download 04/19/2023 IQC Results Subject:
cobash232.roche.com Validity:
01.01.2022 00:00:00 01.02.2024 23:59:50 Fingerprint:
SHA256 3C:15:3B:BC:FA:8A:47:F5:D2:
F7:9A:06:28:0E:FC:B9;F4:7A.B C:84:BA:97:95:7E:8D:62:90:C D:26:D1:D9:1C New 04/19/2023 1 Touch Client Certificate to display the Client screen. The Client screen contains the following infor-
mation:
Subject: shows the common name of the certificate and its approval status. Validity: shows the time range of the cer-
tificates validity. When the time range is exceeded the expired icon played. is dis-
Fingerprint: shows the fingerprint type and the fingerprint. The fingerprint is the unique identifier of the certificate. 2 Touch New to renew the client certificate. 3 In the following message, touch to confirm that you want to renew the certif-
icate, or touch to cancel the process without renewing the certificate. 4 Touch menu. to return to the Certificates Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 90 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 90 (228) Managing server certificates You can display and review existing server certificates, activate not yet approved certificates and delete expired or invalid certificates. Meter Setup Certi cates Client Certi cate Server Certi cates Root CA Certi cates Credential Download 04/19/2023 Server In nity Edge In nity Edge POCT-Plus POCT-Plus Foreigner IQC Results Subject:
POCT-Plus Validity:
01.01.2022 00:00:00 01.02.2024 23:59:59 Fingerprint:
SHA256 3C:15:3B:BC:FA:8A:47:F5:D2:
F7:9A:06:28:0E:FC:B9;F4:7A.B C:84:BA:97:95:7E:8D:62:90:C D:26:D1:D9:1C 04/19/2023 04/19/2023 IQC Results Subject:
Foreigner Validity:
01.01.2022 00:00:00 01.02.2024 23:59:50 Fingerprint:
SHA256 3C:15:3B:BC:FA:8A:47:F5:D2:
F7:9A:06:28:0E:FC:B9;F4:7A.B C:84:BA:97:95:7E:8D:62:90:C D:26:D1:D9:1C 04/19/2023 1 Touch Server Certificate to display the Server screen with a list of certificates. 2 Touch the server certificate you wish to display. The Server screen contains the following information:
Subject: shows the common name of the certificate and its approval status. Validity: shows the time range of the cer-
tificates validity. When the time range is exceeded the expired icon played. is dis-
Fingerprint: shows the fingerprint type and the fingerprint. The fingerprint is the unique identifier of the certificate. 3 Manage certificates as follows:
Touch to approve a server certificate which is not yet approved. Touch to delete a certificate. 4 In the following message, touch to confirm that you want to approve or delete the certificate, or touch to cancel the process without changing the certificate status. 5 Touch to return to the Server menu. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 91 (228) 91 Meter Setup Managing Root CA certificates You can display and review existing Root CA certificates, and delete expired or invalid certifi-
cates. Root CA Roche Diagnostics Sub C In nity Edge POCT-Plus POCT-Plus In nity Edge 04/19/2023 Certi cates Client Certi cate Server Certi cates Root CA Certi cates Credential Download 04/19/2023 IQC Results Subject:
Innity Edge Validity:
01.01.2022 00:00:00 01.02.2024 23:59:59 Fingerprint:
SHA256 3C:15:3B:BC:FA:8A:47:F5:D2:
F7:9A:06:28:0E:FC:B9;F4:7A.B C:84:BA:97:95:7E:8D:62:90:C D:26:D1:D9:1C 04/19/2023 1 Touch Root CA Certificates to display the Root CA screen with a list of certificates. 2 Touch or to scroll through the list. 3 Touch the Root CA certificate you wish to display. The Root CA screen contains the following information:
Subject: shows the common name of the certificate, its approval status, and the text built in if the certificate is built-in. Validity: shows the time range of the cer-
tificates validity. When the time range is exceeded the expired icon played. is dis-
Fingerprint: shows the fingerprint type and the fingerprint. The fingerprint is the unique identifier of the certificate. 4 Touch to delete a customer installed certificate. Built-in certificates can not be deleted. 5 In the following message, touch to confirm that you want to approve or delete the certificate, or touch to cancel the process without changing the certificate status. 6 Touch menu. to return to the Root CA Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 92 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 92 (228) Downloading credentials Meter Setup For downloading meter credentials the meter must be placed in a configured Handheld Base Unit. Certi cates Client Certi cate Server Certi cates Root CA Certi cates Credential Download 04/19/2023 1 Touch Credential Download to display the Cred. Download screen. 2 Touch PIN to enter the required pin. 3 Touch to download a new meter credential via the Handheld Base Unit. Cred. Download To download meter credentials, place meter in Handheld Base Unit and press the download button. 4 Touch menu. to return to the Certificates PIN 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 93 (228) 93 Meter Setup 3.4 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 177. 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 177. Operator IDs can be selected from a list (if available) or read by the barcode scanner. If pass-
words were created, they must be entered via the onscreen keypad. Patient IDs can be entered by using the onscreen keypad or the barcode scanner. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 94 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 94 (228) 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 95 (228) 95 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 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 96 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 96 (228) Enter Administrator ID
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 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. ABC to switch back to the input of 6 Use text. 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 97 (228) 97 Meter Setup Repeat Administrator ID
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 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 Touch to exit this menu, the 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 98 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 98 (228) 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). Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Enter Administrator ID Optional Screens
04/19/2023 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 Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 99 (228) 99 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. Meter Setup Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Enter Administrator ID
Optional Screens 04/19/2023 Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 A F K P U Z A F K P U Z
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 E J O T Y E J O T Y Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 100 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 100 (228) 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. 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) Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 101 (228) 101 Meter Setup Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 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. Select Operator ID Off Optional Required Scan Only 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 102 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 102 (228) Operator ID Alphanum. Numeric Max. Length:
20 04/19/2023 Meter Setup 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 103 (228) 103 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 177). With an Operator list being transferred to the meter, the Operator ID options are different from the options in standalone mode. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - ID Setup Administrator ID Operator ID Patient ID Select Operator ID None List Hidden List 04/19/2023 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 104 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 104 (228) 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 177). 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.) Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 Setup Basics Data Handling ID Setup Lockout Optional Screens 04/19/2023 Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 105 (228) 105 Meter Setup Setup - ID Setup Administrator ID Operator ID Patient ID 04/19/2023 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. Select Patient ID Off Optional Required Hidden List 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 106 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 106 (228) Patient ID Alphanum. Numeric Max. Length:
20 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 107 (228) 107 Meter Setup 3.5 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 101) 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 108 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 108 (228) 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 Setup Basics 04/19/2023 Data Handling ID Setup Lockout Optional Screens Setup - Lockout Operator Lockout 04/19/2023 QC Settings Cleaning Lockout STAT Test Con g. 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 109 (228) 109 Meter Setup 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 Select Operator Lockout 5 Touch or to display the option of No Daily Weekly Monthly Every 3 Months 04/19/2023 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 deactivated. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 110 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 110 (228) 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 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 111 (228) 111 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) Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 112 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 112 (228) 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. Main Menu 09:15 am Patient Test Control Test Review Results Setup Setup Basics 04/19/2023 Data Handling ID Setup Lockout Optional Screens Setup - Lockout Operator Lockout 04/19/2023 QC Settings Cleaning Lockout STAT Test Con g. 04/19/2023 Setup - QC Settings QC Lockout IQC Lockout QC Result Format QC Range Reset Test Param. 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 113 (228) 113 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 114 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 114 (228) See page 113 on how to access the Setup-QC Settings menu. Meter Setup Setup - QC Settings Setup - Lockout QC Lockout IQC Lockout QC Result Format QC Range Reset Test Param. New Lot:
Yes No No Daily Weekly Monthly 04/19/2023 04/19/2023 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). If you select two levels, two different control levels are required for every parameter. It is not possible to unlock a QC lockout by performing multiple tests with the same control level. 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 115 (228) 115 Meter Setup 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:
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 113 on how to access the Setup-QC Settings menu. Setup - QC Settings Select IQC Lockout QC Lockout IQC Lockout QC Result Format QC Range Reset Test Param. No Daily Weekly Monthly 04/19/2023 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 116 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 116 (228) 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:
Meter Setup Display without a value, but with text Pass or Fail Display a value Display as value and with text Pass or Fail See page 113 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 QC Range Reset Test Param. 04/19/2023 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 117 (228) 117 Meter Setup Custom Range The quality control range for Troponin T, D-Dimer and proBNP can be customized to comply with local guidelines. The Custom Range 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 113 on how to access the Setup-QC Settings menu. Do not use the Custom Range option when using level 1 controls. The target value is outside of the quantitative measuring range. Setup - QC Settings QC Lockout IQC Lockout QC Result Format QC Range Reset Test Param. 04/19/2023 Select QC Range Par:
Troponin T Default Range Custom Range 04/19/2023 1 Touch QC Range to set the quality control range. 2 Touch the button with the parameter you wish to set. Select Parameter You may select from the following options:
Troponin T D-Dimer proBNP 04/19/2023 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). 3 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. If you selected Custom Range, touch to exit this to proceed with corresponding settings, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 118 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 118 (228) Meter Setup Select QC Range Select Deviation Par:
Troponin T Par:
Troponin T Default Range Custom Range Deviation from target value
(in %):
21 If you selected Custom Range, the Select Deviation screen opens and offers you the option of customizing the deviation from target value (percentage value). 04/19/2023 04/19/2023 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%). 4 Use the arrows to to set the allowed per-
centage deviation from the target value. Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 119 (228) 119 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 113 on how to access the Setup-QC Settings menu. Setup - QC Settings Reset Test Parameter QC Lockout IQC Lockout QC Result Format QC Range Reset Test Param. Do Reset No Reset 04/19/2023 04/19/2023 5 Touch Reset Test Param. to reset all stored test parameters and QC lockouts. 6 Select Do Reset and confirm by to reset the test parameters, to exit without resetting the touching or touch test parameters (this leads to the same result as selecting and confirming No Reset). The display automatically returns to the previous screen. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 120 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 120 (228) 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. Main Menu 09:15 am 1 From the Main Menu, touch Setup to open Patient Test Control Test Review Results Setup the meter settings. 2 From the Setup menu, touch Lockout. 3 From the Setup-Lockout menu, touch Cleaning Lockout. Setup Basics You may select from the following options:
04/19/2023 Data Handling ID Setup Lockout Optional Screens 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. Setup - Lockout Operator Lockout 04/19/2023 QC Settings Cleaning Lockout STAT Test Con g. 04/19/2023 Select Cleaning Lockout No Daily Weekly Monthly 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 121 (228) 121 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 122 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 122 (228) Meter Setup Main Menu 09:15 am 1 From the Main Menu, touch Setup to open Patient Test Control Test Review Results Setup Setup Basics 04/19/2023 Data Handling 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. ID Setup Lockout 5 If you have enabled the option, touch or to set the number of additional tests. Optional Screens 6 Touch to save this setting, or touch to exit this menu without saving any changes. The display automatically returns to the previous screen. Setup - Lockout Operator Lockout 04/19/2023 QC Settings Cleaning Lockout STAT Test Con g. 04/19/2023 STAT Test Enable Disable Quantity:
3 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 123 (228) 123 Meter Setup 3.6 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. Main Menu 09:15 am Patient Test Control Test Review Results Setup 04/19/2023 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 Setup Basics Data Handling ID Setup Lockout Optional Screens Setup - Optional Screens Start Info Result Login Result Con rmation 04/19/2023 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 124 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 124 (228) 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 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. 04/19/2023 04/19/2023 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 04/19/2023 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 125 (228) 125 Meter Setup 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. Start Info Result Login Result Con rmation Enable Disable 04/19/2023 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 126 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 126 (228) 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 Before use, visually check if the packaging of the Cardiac pipettes and/or the pipettes are intact. If the needle falls off or gets stuck during use, do not try to re-cap it. Stop using the pipette immediately and dispose of it in a sturdy sharps container (in accordance with applicable local regula-
tions and directives and your facilitys guidelines). This information applies to the following products:
Cardiac pipettes 150 L 20 pc. (int.) (REF 11622889190) Syringe 150 L 5 pc. Japan (REF 05904528001) 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 127 (228) 127 Performing a Test Always operate the meter according to the specified operating conditions (see page 197). 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 183. 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 without protection. 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 diagnosis, therefore posing danger to the patient. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 128 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 128 (228) Sample material WARNING Performing a Test Proper sample collection In order to avoid false test results which may lead to inaccurate thera-
peutic decisions adhere to the following when collecting blood samples:
Only use heparinized venous whole blood 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 collection 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 145. 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 17. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 129 (228) 129 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 2721 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 130 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 130 (228) 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 193). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 131 (228) 131 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 132 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 132 (228) Performing a Test 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 Sample Result Test strip Patient ID/list Sample Result Test strip Sample Result Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 133 (228) 133 1 Power the meter on by pressing the button. 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. Performing a Test Powering on the meter Self-Check 09:15 am Self-Check 09:15 am Performing self-checks... SW Version: v04.03.00 Self-checks complete. 04/19/2023 SW Version: v04.03.00 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 134 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 134 (228) 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 04/19/2023 With operator login (no operator list) Enter Operator ID SC123 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 2 Enter or scan your Operator ID. 3 Touch to confirm your entry. 4 Wait until the main menu is displayed. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 135 (228) 135 Performing a Test With operator login (list available) Operator OP003 Hall, Molly-Jessica OP001 Hughes, Adam OP002 Patel, Al e-Adam 04/19/2023 2 If an operator list exists, wait until this list 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 Hold the card with the barcode approx. 15 cm (6 in) from the scanner. It is not possible to connect an external bar-
code scanner to the meter. The scanner equipped cobas h 232 meter described in this manual provides a camera based 2D barcode scanner, instead of the laser scanner used in previous meter versions. Established scanning procedures may need some corresponding adjustments:
the nominal distance between scanner and barcode is slightly different avoid reflections on the barcode (e.g. by reflective foils etc.) ensure an adequate size and quality of barcodes See Appendix A for further details on barcode handling. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 136 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 136 (228) Performing a Test 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. Password
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 With operator login (list hidden) Enter Operator ID SC123 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 2 Enter or scan an existing Operator ID from the hidden list. Password 3 Touch to confirm your entry.
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 4 Wait until the main menu is displayed. 5 Enter the password. 6 Touch to confirm your entry, or touch to display the operator list again. 7 Wait until the main menu is displayed. In the Operator login screens with list or to open the hidden list you can touch Configuration Manager. The Configuration Manager is required to renew expired TLS certificates in case of missing administrator access to the meter setup. For more informa-
tion, contact your local affiliate or Roche Service representative. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 137 (228) 137 Performing a Test Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 138 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 138 (228) 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. For further details see page 29. 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 155). 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 183. 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. 4.2 Performing a test Main Menu 09:15 am Patient Test Control Test Review Results Setup Logout 04/19/2023 Main Menu 09:15 am QC Lockout Control Test Review Results Setup Logout Main Menu 09:15 am Cleaning Lockout Cleaning Review Results Setup 04/19/2023 Clean Meter 04/19/2023 Remove Cover 04/19/2023 Main Menu 09:15 am QC!
Patient Test Control Test Review Results Setup Logout 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 139 (228) 139 Performing a Test Without patient list 3 Touch Patient Test. Patient ID PID111SCHULZM457 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 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 143. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 140 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 140 (228) 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. 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. Select Patient ID PID001GERTA123 Anders, Gert PID001BERNDH123 Bernd, Hans PID001CHAPLINC123 Chaplin, Charlene PID001FRENZENA12 Frenzen, Alice PID230ONEALJ1234 ONeal, John New 04/19/2023 Patient ID PID111SCHULZM457 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 141 (228) 141 Performing a Test Select Patient ID PID001GERTA123 Anders, Gert PID001BERNDH123 Bernd, Hans PID001CHAPLINC123 Chaplin, Charlene PID001FRENZENA12 Frenzen, Alice PID230ONEALJ1234 ONeal, John New 04/19/2023 The Patient ID can also be entered via bar-
code (meters with a barcode scanner only). Touch and hold either a card with the barcode approx. 15 cm
(6 in) 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 142 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 142 (228) Inserting a test strip Pat. Test - Ins. Strip Pat:
Op:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM Insert Strip 04/19/2023 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). WARNING Test strip deterioration 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 143 (228) 143 Performing a Test Pat. Test - Ins. Chip Par:
proBNP Insert Code Chip 2721 04/19/2023 If you use a new test strip lot, you must insert the corresponding code chip once. See Code chip on page 130. 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). Pat. Test - Warming Up Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Please Wait Warming Up 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 144 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 144 (228) Performing a Test 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 193. 4 Use the Roche CARDIAC Pipette (or other suitable pipettes with a pipetting volume of 150 L). Draw exactly 150 L (to the blue mark on the pipette) heparinized blood from the blood collection tube. Select Operator ID Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 150 L Apply Sample 4:10 Min 04/19/2023 1 5 0 L WARNING Potential risk of incorrect patient results In order to avoid inaccurate test results, make sure the blood sample is homogenized (by gently swirling the blood collection tube several times) and ensure the blood sample contains no air bubbles when it is in the pipette. Inaccurate test results may lead to inappropriate therapeutic decisions. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 145 (228) 145 Performing a Test 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. CAUTION 5 Apply the entire sample to the sample application area of the test strip. 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 146 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 146 (228) Performing a Test 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. Pat. Test - Measuring Pat:
SCHULZ, MANFRED Op:
Par:
JONES, TOM proBNP Code:
PB1234 10:20 Min 04/19/2023 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 04/19/2023 For Troponin T only:
As soon as the meter detects a signal (this may take a few minutes), a qualitative message (TnT Elevated) appears under the hourglass icon (see illustration). The final quantitative result is displayed when the test is completed. Decisions on further treatment of the patient should be based on the final result only. Refer to the Roche CARDIAC T Quantitative or Roche CARDIAC POC Troponin T package insert for more details. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 147 (228) 147 Performing a Test Pat. Test - Result Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 10:17 620 pg/mL 04/19/2023 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 183). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 148 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 148 (228) Displaying, confirming or adding comments to results As described in the chapter Optional Screens setup starting on page 124, there are many options for displaying results that can be activated:
Performing a Test If a new Operator Login is required to display the result:
Pat. Test - Op. Login 1 Touch the button for Operator Login. Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Measurement Complete 04/19/2023 2 Log in as described on page 136. The result is now displayed. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 149 (228) 149 Performing a Test Pat. Test - Con rm. Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 10:17 620 pg/mL Measurement OK?
Reject Accept 04/19/2023 Pat. Test - Result Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 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. 04/19/2023 10:17 Rejected 04/19/2023 If you miss to finish a required confirmation before the meter is powered off automatically, the test result will be stored and displayed along with a Result not validated comment. However, if a confirmation is required, the meter reminds you to do so with a series of triple beeps (once a minute for the last 3 minutes) before powering off. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 150 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 150 (228) 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 Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 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 04/19/2023 Custom The comments are stored with the test result. 04/19/2023 Pat. Test - Result Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 10:17 620 pg/mL Symptomatic Chest Pain Test 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 151 (228) 151 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 68 and following). Otherwise it is not displayed. Pat. Test - Result Pat. Test - Result Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 10:17 620 pg/mL 04/19/2023 04/19/2023 1 Touch code. 2 Touch display. to display the result as QR to return to the standard result The size of the QR code displayed on the screen varies according to the amount of data encoded. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 152 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 152 (228) STAT tests STAT tests are a limited number of tests that can be performed in emergency situations, see page 122. 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. Performing a Test Pat. Test - Lockout Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 Test Parameter Locked!
Please Perform QC. STAT 04/19/2023 Pat. Test - Result Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 04/19/2023 10:17 620 pg/mL STAT Test 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 153 (228) 153 Performing a Test This page intentionally left blank. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 154 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 154 (228) 5 Control Testing and Quality Control Control Testing and Quality Control The cobas h 232 meter employs several methods to check that the meter and test strips are wor-
king 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 meter 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 155 (228) 155 Control Testing and Quality Control WARNING Potential risk of incorrect patient results Failure to check the system regularly by performing quality control tests may lead to incorrect results and therefore to inappropriate therapy deci-
sions. To ensure that the system is functioning properly adhere to the manufacturer recommendations on quality control testing given in the tables below. Manufacturer recommended frequency of quality control tests:
Frequency Daily*
Material to test Reason CARDIAC IQC High and CARDIAC IQC Low Verification of the proper functioning of the optical system Release criteria Both levels are Pass
*only on days when the cobas h 232 meter is used for measurements Manufacturer recommended use:
Frequency Once a month With each new shipment of test strips When an implausible result is obtained When an operator uses the cobas h 232 system
(meter with or without scanner) for the first time After adverse events such as dropping the meter or other strong mechanical shocks. Material to test Reason Release criteria To verify adequate storage at customer site To verify proper function-
ing after transportation to customer site To qualify the new operator; to verify proper handling and sample dosing To verify proper function-
ing of the meter Results are within the range provided by the manufacturer Results are within the range provided by the manufacturer Roche CARDIAC Controls Roche CARDIAC Controls and CARDIAC IQC High and CARDIAC IQC Low QC recommendations by national associations or local hospital guidelines take precedence over manufacturer recommendations Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 156 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 156 (228) Control Testing and Quality Control 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 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 108). If you encounter a lockout for a test strip lot that no longer exists, see Reset test parameters on page 120. Please note that, when you use this method, all saved test parameters and QC lock-
outs will be deleted. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 157 (228) 157 Control Testing and Quality Control 5.2 Performing a quality control test Quality control (QC) 1 Power the meter on by pressing the button. 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 136. Main Menu 09:15 am 2 Wait until the main menu is displayed. QC!
Patient Test Control Test Review Results Setup 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 158 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 158 (228) Main Menu 09:15 am QC!
Patient Test Control Test Review Results Setup QC Test - QC Status QC Status CK-MB DDimer Myo
- Pass
- Pass
- Pass proBNP Trop T
- Locked
- Locked 04/19/2023 QC Test - Ins. Strip Op:
JONES, TOM Insert Strip 04/19/2023 04/19/2023 Control Testing and Quality Control 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). CAUTION Test strip deterioration 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 159 (228) 159 Control Testing and Quality Control QC Test - Sel. QC Lot Par:
pro BNP Code:
PB1234 Op:
JONES,TOM Code PBC014 Code PBC016 Code PBC017 Code PBC018 New 04/19/2023 QC Test - Ins. Chip Par:
QC:
Op:
Code:
proBNP PBC014 JONES, TOM PB1234 QC Insert Code Chip PBC014 04/19/2023 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 160 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 160 (228) QC Test - Sel. QC Level Par:
QC:
Op:
Code:
proBNP PBC014 JONES, TOM PB1234 Level 1 Level 2 04/19/2023 QC Test - Warming Up Par:
QC:
Op:
proBNP, PBC014 JONES, TOM Code:
Level: 1 PB1234 Please Wait Warming Up 04/19/2023 QC Test - App. QC Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level: 1 PB1234 150 L Apply QC 4:10 Min 04/19/2023 Control Testing and Quality Control 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 193. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 161 (228) 161 Control Testing and Quality Control 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. CAUTION 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. 12 Touch to confirm that the sample has been applied. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 162 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 162 (228) Control Testing and Quality Control 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). 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. QC Test - Processing Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 Processing... 04/19/2023 QC Test - Measuring Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 10:20 Min 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 163 (228) 163 Control Testing and Quality Control QC Test - Result QC Test - Result Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 The result of this quality control test is dis-
played and is automatically saved to memory. 04/19/2023 10:17 04/19/2023 10:17 Pass:
329 pg/mL Fail:
490 pg/mL
(350 / 300-400 pg/mL)
(350 / 300-400 pg/mL) 04/19/2023 04/19/2023 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 117 and Settings summary on page 50. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 164 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 164 (228) Control Testing and Quality Control Print button:
Print results (infrared interface) 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 183). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 165 (228) 165 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 meter. 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 meter 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 166 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 166 (228) Control Testing and Quality Control The first steps in this quality control test are identical to the procedure described before, see page 158. The following description therefore starts at the main menu. Main Menu 09:15 am QC!
Patient Test Control Test Review Results Setup 04/19/2023 QC Test - QC Status QC Status CK-MB DDimer Myo
- Pass
- Pass
- Pass proBNP Trop T
- Locked
- Locked QC Test - Ins. Strip Op:
JONES, TOM 04/19/2023 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 159. 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 04/19/2023 QC Test - Ins. Chip IQC Par:
Op:
JONES, TOM QC Insert Code Chip 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 167 (228) 167 Control Testing and Quality Control Par:
QC Test - Measuring IQC IQC702 Code:
Level: 1 Op:
JONES, TOM 04/19/2023 QC Test - Result Par:
IQC Code: IQC702 Level: 1 Op:
JONES, TOM 19/04/2023 10:17 83 %
(85 / 82 - 88 %) 04/19/2023 The hourglass icon is displayed and the
(internal) 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 117 and Settings summary on page 50. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 168 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 168 (228) 6 Review Results Review Results The cobas h 232 meter can save 2000 patient test results as well as 500 quality control and 200 IQC 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. 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 136. Main Menu 09:15 am 2 Wait until the main menu is displayed. Patient Test Control Test Review Results Setup 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 169 (228) 169 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 Patient History All Results QC Results Review Results IQC Results Setup Mainten. History 04/19/2023 04/19/2023 The print button only appears if the printer function is activated. Otherwise it is not displayed. Patient results only: The QR code button only appears if the QR code display function is activated. Otherwise it is not displayed. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 170 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 170 (228) 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 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. 04/19/2023 Single Patient Results Pat:
PID111SCHULZM457 SCHULZ, MANFRED DDimer High 02/12/23 08:30 proBNP 620 pg/mL 02/08/23 09:49 DDimer 1.3 g/mL 01/21/23 09:15 Pat:
Op:
Par:
3 Touch or of choice on the screen. to display the test result Patient Result 4 Touch the test result you would like to PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 view in detail. 04/19/2023 02/08/2023 09:49 620 pg/mL New Strip Lot 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 171 (228) 171 Review Results All results This memory area contains a list of all patient tests, sorted chronologically. From here, you can call up results for specific times. 1 Touch or choice on the screen. to display the entry of 2 Touch the patient name whose result you want to open. All Results Doe, John 02/16 10:52 Trop-T Smith, Adam 02/16 10:11 proBNP Zend, Nora 02/16 09:40 DDimer Smith, Bob 02/15 11:40 Trop-T Smithee, Aaron 02/15 10:50 proBNP 04/19/2023 Patient Result The selected test result dialog box will appear. When you touch selected patient is displayed (see page 171).
, a list of results for the Pat:
Op:
Par:
PID111SCHULZM457 SCHULZ, MANFRED JONES, TOM proBNP Code:
PB1234 02/08/2023 09:49 620 pg/mL New Strip Lot 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 172 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 172 (228) Quality control (QC) results This memory area contains all test parameter-specific quality control tests (QC, starting on page 158) that were run, sorted chronologically. The most recent results are at the top of the list. Review Results 1 Touch or choice on the screen. to display the entry of 2 Touch the entry you want to open. The entry is displayed. QC Results DDimer L2 02/12/23 08:30 DDimer L1 02/12/23 08:00 proBNP L1 02/04/23 10:17 DDimer L2 01/10/23 07:30 DDimer High 01/10/23 07:05 04/19/2023 QC Results Par:
QC:
Op:
proBNP PBC014 JONES, TOM Code:
Level:
PB1234 1 02/04/2023 10:17 329 pg/mL
(350 / 300-400 pg/mL) Pass:
04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 173 (228) 173 Review Results Instrument quality control (IQC) results This memory area contains all instrument quality control tests (IQC, starting on page 166) that were run, sorted chronologically. The most recent results are at the top of the list. 1 Touch or choice on the screen. to display the entry of 2 Touch the entry you want to open. The entry is displayed. IQC Results IQC Pass 04/11/23 07:59 IQC Pass 04/07/23 08:16 IQC Fail 04/07/23 08:01 IQC Pass 03/29/23 08:30 IQC Pass 03/29/23 09:02 04/19/2023 QC Test - Result Par:
IQC Code:
Level: 1 IQC702 Op:
JONES, TOM 04/19/2023 07:59 83 %
(85 / 82 - 88 %) 04/19/2023 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 174 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 174 (228) 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 04/13/2023 08:00 Meter Cleaned 04/05/2023 08:20 Meter Cleaned 03/29/2023 09:00 New Battery Pack 03/21/2023 08:30 Meter Cleaned 03/14/2023 08:10 New 04/19/2023 1 Touch or choice on the screen. to display the entry of 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 175 (228) 175 Review Results This page intentionally left blank. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 176 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 176 (228) 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. Preferably use incremental list updates instead of complete list updates, if your DMS supports this setup option. 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 101, for details on Operator Lockout see page 109. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 177 (228) 177 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 71). For wired communication, 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. For wireless communication, additional installation steps via DMS are required. Please contact your local Roche representative for further information. For further details on WLAN configuration see Appendix B. Software updates Please Wait Updating Software... Software updates are installed via DMS. The meter accepts updates triggered by the DMS only when it is idle and when the battery icon shows at least three segments. The screen on the left will be displayed when an update is in progress. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 178 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 178 (228) 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 101 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 179 (228) 179 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 180 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 180 (228) Extended Functionalities 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. 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 205 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 181 (228) 181 Extended Functionalities The default preset comments in the meter are:
Patient and QC Result comments Maintenance comments Meter Cleaned Samp. App. Area Cl. (Sample Application Area Cleaned) Test Strip Guide Cl. (Test Strip Guide Cleaned) New Battery Pack 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 182 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 182 (228) 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). Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 183 (228) 183 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 20 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. Transport safety of the Handheld Battery Pack is proven to meet the requirements of each test in the UN Manual of Tests and Criteria, Part III, subsection 38.3. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 184 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 184 (228) 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 121) 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 housing (entire meter surface including display) 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 185 (228) 185 Maintenance and Care WARNING 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 186 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 186 (228) 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 Recommended disinfecting agents 70 % (or less) solution of isopropyl alcohol in water NOTICE Do not use any other disinfectants/cleaning agents on the meter (hous-
ing or the test strip guide cover). Use of other disinfectants/cleaning agents could result in damage to the meter. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 187 (228) 187 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 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. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 188 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 188 (228) Cleaning the meter Only use the cleaning agents recommended on page 187. Procede as follows for cleaning the meter. 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 dry and fresh tissue. 3 Clean the outside of the meter with a lightly moistened tissue. Then dry the meter with a fresh tissue. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 189 (228) 189 Maintenance and Care 4 Clean the easily accessible and visible pipetting field area of the test strip guide with moistened lint-free tissues. WARNING Protection against instrument damage In order to avoid instrument damage, adhere to the following:
Clean only the visible area (large circle) of the test strip guide. Do not insert any objects into the concealed 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. 5 Clean the membrane (small circle) in the visible area at the end of the test strip guide with a moistened tissue. 6 Allow the inside of the test strip guide to dry for about 10 minutes. 7 Continue with disinfecting the meter. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 190 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 190 (228) Disinfecting the meter Follow the procedures described above for cleaning the meter, with the following differences:
Only use the disinfecting agents recommended on page 187. Maintenance and Care 1 Wipe the test strip guide cover, the out-
side of the meter and only the visible area of the test strip guide three times horizontally and three times vertically with a lightly moistened tissue. 2 Wait for the disinfection time according to the instructions of the used disinfection agent. 3 Dry the test strip guide cover and the outside of the meter with a dry and fresh tissue. Adhere to the following:
Do not insert dry tissues into the test strip guide. Do not insert any objects into the con-
cealed areas of the test strip guide. That would damage the optical components of the meter. 4 Re-attach the test strip guide cover to the housing. CAUTION Protection against instrument damage To avoid instrument damage, always ensure that the test strip guide cover is completely dry before reattaching it. Make sure that the cover is properly attached. If so, you will hear it snap into place. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 191 (228) 191 Maintenance and Care This page intentionally left blank. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 192 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 192 (228) 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 219). The two different message types are illustrated below:
Display/symptom Description I-001: Battery Low Battery Low I-001 The battery is getting low. 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 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 193 (228) 193 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 If you notice any issues with the display functionality (e.g. unexpected lines/marks on the meter display) stop using the system and contact your Roche representative. 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:
Is the Handheld Battery Pack properly installed in the meter?
Refer to the package insert for the test strips. Press the On/Off button to reactivate the meter/screen. Meter displays an unexpected result Automatic shutdown The meter powers off after a configurable time with-
out activity (e.g., pressing a key, touching the screen) to conserve energy. Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 194 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 194 (228) 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 86). Dock the RF enabled meter into a hard-wired base unit to transfer the data. Reset the meter. If the error persists, contact your Roche representative. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 195 (228) 195 Troubleshooting Meter reset A hard 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 pack. 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: v04.03.00 Self-checks complete. 04/19/2023 SW Version: v04.03.00 time appear. 04/19/2023 Year:
Month:
Day:
Set Date 2023 1 Hour:
Set Time 3 1 Minutes:
49 04/19/2023 AM PM 04/19/2023 3 Enter the date and time. After you have entered the correct information, confirm
. each screen with Unless all lockouts are disabled (see chapter 3.5), 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 196 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 196 (228) General Product Specifications 10 General Product Specifications 10.1 Operating conditions and technical data Technical data Temperature range 18-32 C Relative humidity Maximum altitude Position 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. Measuring range Depends on test parameters Memory Interface Supported barcodes Battery operation Mains connection 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 2/5, Codabar, GS1 DataBar Limited, QR Code, DataMatrix, PDF417, Aztec Handheld battery pack Power adapter (REF 07006098001) Input: 100-240 V AC ( 10%) / 50-60Hz / 350-150 mA Output: 12 V DC / 1.25A Power adapter (REF 08692432001) Input: 100-240 V AC ( 10%) / 50-60Hz / 400-200 mA Output: 12 V DC / 1.5A Number of tests with fully charged battery approx. 10 tests Safety class III Automatic power-off Programmable 1 60 minutes Dimensions Weight 244 105 51 mm approx. 526 g incl. battery pack and scanner Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 197 (228) 197 General Product Specifications Sample material Sample type Sample size Interactions Storage conditions Temperature range Meter
(without battery pack) Temperature range Meter (with installed battery pack) Heparinized venous whole blood 150 L Refer to test strip package insert 5 C to +45 C (+23 F to +113 F) 5 C to +35 C (+23 F to +95 F) Relative humidity 10 to 85% (no condensation) Transport conditions Temperature range Meter
(without battery pack) Temperature range Meter (with battery pack contained in the kit)a Relative humidity 25 C to +70 C 25 C to +70 C 10 to 85% (no condensation) a. At temperatures above +70 C/158 F the battery pack could leak and damage the meter. At temper-
atures below -10 C/+14 F the battery pack does not have enough power to keep the internal clock functioning. 10.2 Further information List of available assays, accessories and consumables Below is a list of available accessories and consumables. For ordering information, contact your local sales representative. Item Description Roche CARDIAC POC Troponin T Roche CARDIAC POC Troponin T Control 10 tests for quantitative detection of cardiac Troponin T Control set for use with Roche CARDIAC POC Troponin T (control set for 2 x 6 quality control checks, level 2, and code chip) REF 07007302XXX 07089643190 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 198 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 198 (228) General Product Specifications Item Description Roche CARDIAC POC Troponin T 2 Level Control Roche CARDIAC POC Troponin T Control (Germany only) Control set for use with Roche CARDIAC POC Troponin T (control set for 2 x 6 quality control checks, level 1/2, and code chip) Control set for use with Roche CARDIAC POC Troponin T (control set for 2 x 6 quality control checks, level 2, and code chip) REF 07831005190 07912218190 Roche CARDIAC M Myoglobin 20 tests for quantitative detection of myoglobin 04877799190 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) 04890469190 Roche CARDIAC D-Dimer 10 tests for quantitative detection of D-Dimer 04877802XXX Roche CARDIAC Control D-Dimer Roche CARDIAC proBNP+
Roche CARDIAC Control proBNP Roche CARDIAC POC NT-proBNP Roche CARDIAC POC NT-proBNP Control Control set for use with Roche CARDIAC D-Dimer (control set for 2 x 6 quality control checks, level 1/2, and code chip) 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 NT-proBNP
(measuring range 60 - 9,000 pg/mL for meter software version 01.04.01) Control set for use with Roche CARDIAC POC NT-proBNP 10 tests (control set for 2 x 6 quality control checks, level 1/2, and code chip) Roche CARDIAC CK-MB 10 tests for quantitative detection of CK-MB Roche CARDIAC Control CK-MB Roche CARDIAC IQC 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 04890523190 05533643XXX 04890493190 09213074XXX 09302344190 04877900190 04890426190 04880668190 Roche CARDIAC pipettes 20 disposable syringe pipettes (150 L) for blood application 11622889190 Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 199 (228) 199 General Product Specifications Item Description REF Rechargeable battery pack for cobas h 232 meter 06869904001 Universal battery pack Test strip guide cover Battery compartment cover Power adapter *
Handheld Base Unit cobas h 232 meter cobas h 232 meter Version without scanner/without WLAN Version with scanner/with WLAN Printer cobas h 232 (CMP-10) ROW for most North American, Latin American and Asian countries Printer cobas h 232 (CMP-10) EMEA for most European, Middle East and African countries Printer cobas h 232 (CMP-10) JAP for Japan Normal thermal paper roll 5 rolls per package, 50 mm diameter Thermal paper roll (self-adhesive) 10 rolls per package, 50 mm diameter 07751109001 07751125001 08692432001 04805658001 04901126XXX 04901142XXX 05404495001 05404517001 05404509001 03666751001 05412951001
* Important note Power adapter REF 07006098001 (International edition), Type: FW7555M/12, Input: 100-240V/50-60Hz/350-150 mA, Output:
1.25A 12V has been discontinued and replaced by:
Power adapter REF 08692432001 (International edition), Type: FW8001M/12, Input: 100-240V/50-60Hz/400-200 mA, Output:
1.50A 12V The change in power adapter has no effect on product performance. Type: FW7555M/12 and Type:
FW8001M/12 can be used in parallel. Note: Not all items are available in all countries. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 200 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 200 (228) 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 201 (228) 201 Warranty This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 202 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 202 (228) A Appendix A.1 Working with barcodes Appendix WARNING Risk of barcode read errors 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 203 (228) 203 Appendix 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 300 characters for 1D and 2D barcodes. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 204 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 204 (228) A.3 Example of barcode symbologies Appendix 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 barcodes. 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 bar-
codes always refer to the relevant standards 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 205 (228) 205 Appendix Codabar Code 39 Code 93 Code 128 EAN 13 PDF417 Interleaved 2/5 without checksum RSS (GS1 DataBar Limited) Roche Diagnostics Aztec DataMatrix Roche Diagnostics Roche Diagnostics QR Code Roche Diagnostics Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 206 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 206 (228) Appendix 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 207 (228) 207 Appendix This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 208 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 208 (228) Appendix 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 effec-
tively deploying the cobas h 232 system on your wireless network. Whether your meter is equipped with WLAN functionality or not depends on the system configuration that you purchased. For information on WLAN registration see the addendum WLAN registration information, Addendum to the Operators Manual for cobas h 232 which can be downloaded from the Point of Care testing area at www.cobas.com. Background The cobas h 232 meter can only be configured through a data management system to commu-
nicate 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 209 (228) 209 Appendix 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 factors, 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 210 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 210 (228) Appendix 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. Note: For technical reasons, only client certificates in a *.pem file format are acceptable for EAP-TLS authentication. In a Windows-based network environment, *.pfx files need to be con-
verted to *.pem format. It is in the responsibility of the customer / customers IT department to convert *.pfx certificates to the required *.pem format. Important Note:
WEP is an obsolete cryptographic data confidentiality algorithm which is not considered secure. It should not be used anymore. TKIP is an old cryptographic data confidentiality algorithm which is not considered secure. It should not be used anymore, with exception of a backwards compatibility option as a group cipher when connecting to access points that use AES/TKIP mixed mode. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 211 (228) 211 Appendix 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. Communication takes place when the meter is idle, but will be interrupted during the perfor-
mance of a test. 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 admin-
istration, typical population of other clients present, any of the supported security models enabled). 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 212 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 212 (228) Appendix 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 213 (228) 213 Appendix This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 214 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 214 (228) C Supplement for Observed Test Sequence 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. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 215 (228) 215 Supplement for Observed Test Sequence 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 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. Main Menu 09:15 am Patient Test Control Test Review Results Setup Pat. Test - OTS Logout 04/19/2023 OTS enabled Observer Login Patient Test Observer Alan Smithee Ann Casey 04/19/2023 Pat. Test - OTS 04/19/2023 OTS enabled Observer Login Patient Test 04/19/2023 Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 216 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 216 (228) Supplement for Observed Test Sequence Pat. Test - OTS Remove Strip Operator:
OTS enabled Observer Login Patient Test Remove Strip 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:
04/19/2023 04/19/2023 3 Touch to log in again. Observer Login I-010 Observer Alan Smithee, please log in to proceed. Otherwise the OTS test will not be complete. Observer OTS passed:
Pass Fail Measurement Result OK?
Reject Accept Comment:
04/19/2023 4 After you enter your password, touch 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 to add a comment. 8 Touch screen. to return to the Pat. Test - OTS The OTS information is saved together with the test result. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 217 (228) 217 Supplement for Observed Test Sequence This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 218 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 218 (228) D Contact Roche 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 at www.roche.com. Click on Menu, then select Worldwide to find the appropriate local office contact information. In Australia and New Zealand, the cobas h 232 system is manufactured for and distributed by:
Roche Diagnostics Australia Pty Limited ABN 29 003 001 205 2 Julius Avenue North Ryde, NSW, 2113 Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 219 (228) 219 Contact Roche This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 220 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 220 (228) Index A Administrator ..................................................... 95 Administrator ID Change ......................................................... 99 Disable ....................................................... 100 Set up .................................................... 9598 Application area ............................................... 31 Apply sample ................................................... 146 Opening (meter) ....................................... 26 Auto off ................................................................ 65 B Barcode ................................................... 136, 142 Masks ......................................................... 204 Symbologies ............................................. 206 Barcode (test strip) .......................................... 31 Barcode reader ................................................. 31 Barcode scanner .............................................. 26 Basics (setup) ............................................. 5266 Battery pack ......................................... 27, 29, 37 Installing or replacing ...................... 3842 C Certificates ................................................... 8892 Cleaning .................................................. 185190 After mispipetting .................................. 188 Housing - outside .................................. 189 Test strip guide ....................................... 190 Cleaning lockout ............................................ 121 cobas h 232 Contents of the pack .............................. 15 Introduction ................................................ 13 Operating conditions ............................ 197 Overview of meter elements ......... 2628 Test principle ............................................. 15 cobas IT 1000 .................................................... 13 Code chip ......................................... 31, 130131 Opening ....................................................... 28 Comment (custom) ....................................... 151 Comment result .............................................. 151 Computer ............................................6772, 178 Connection ...................................................6774 Contact Roche ................................................ 219 Contents of the pack .......................................15 Contrast .........................................................5253 Control material .............................................. 157 Credentials ..........................................................93 Custom range ........................................118, 119 D Data handling .............................................6792 Data Management System (DMS)
..............................................77, 95, 104, 105, 177 Data transfer ................................................... 177 Date ................................................................5657 Diagnostics ..................................................8692 Display format .............................................6061 Disposal ...................................................... 19, 129 E Error messages ............................................... 193 H Handheld Base Unit .........................................38 I Icons: see Symbols ID setup ...................................................... 94107 Overview ......................................................94 Infections (safety instructions) ................. 129 Infrared interface .................................... 28, 177 IQC lockout ...................................................... 116 L Language ......................................................5455 Lockout .....................................................108123 Cleaning lockout .................................... 121 IQC lockout .............................................. 116 New lot lockout ...................................... 114 Operator lockout ...........................109111 QC lockout ............................................... 115 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 221 (228) 221 M Meter Reset ...........................................................196 Meter setup Administrator ID ................................ 9598 Auto off ........................................................ 65 Basics .................................................... 5266 Cleaning lockout ....................................121 Computer ............................................. 6772 Contrast ................................................ 5253 Data handling ..................................... 6792 Date ........................................................ 5657 Diagnostics .......................................... 8692 Display format .................................... 6061 ID setup ..............................................94107 IQC lockout ...............................................116 Language ............................................. 5455 Lockout ............................................ 108123 New lot lockout .......................................114 Operator ID ..................................... 101104 Operator lockout .......................... 109111 Optional screens ........................... 124126 Overview ............................................... 4651 Patient ID ......................................... 105107 Printer .................................................... 7374 QC lockout ................................................115 QC result format ........................... 117, 118 QR Code ............................................... 6870 Reset test parameters ...........................120 Result confirmation ...............................126 Result display mode ......................... 8485 Result login ...............................................125 Result memory ................................... 7580 Result unit ............................................ 8183 Sound .................................................... 6264 Start info ....................................................125 STAT test ...................................................122 Time ........................................................ 5859 N New lot lockout .............................................. 114 O Observed Test Sequence (OTS) ......215217 On/Off button .....................................................26 Operating conditions .................................... 197 Operating the meter ................................ 3743 Operator ID ......................... 101104, 135138 Operator list ............................................136, 179 Operator lockout ...................................109111 Optional screens ...................................124126 Ordering information .................................... 198 Overview of meter elements ................. 2628 P Patient ID ............................. 105107, 140142 Patient list ...................................... 140142, 180 Power adapter ....................................................29 Connection .......................................... 28, 32 Power supply Contacts (Handheld Base Unit) ..........28 Powering on the meter ............. 134, 158, 169 Printer ............................................................ 7374 Product specifications ................................. 197 Q QC lockout ....................................................... 115 QC result format ....................................117, 118 Quality control ........................................155168 Control material ...................................... 157 IQC (instrument-specific) ..........166168 Pass/Fail .................................................... 168 Preparation ............................................... 157 QC (test parameter-specific) ....158165 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 222 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 222 (228) T Test ............................................................127153 Performing .......................................139153 Preparing .........................................129138 Sample material ..................................... 129 Test area ..............................................................31 Test principle ......................................................15 Test steps (overview) ................................... 132 Test strip Inserting ...........................................143, 159 Lot ............................................................... 112 Test strip guide ..................................................28 Test strip guide cover .....................................26 Time ................................................................5859 Touchscreen ................................................26, 45 Troubleshooting ............................................. 193 W Wi-Fi ......................................................................24 WLAN ................................................................. 209 R Reset ................................................................... 196 Reset test parameters .................................. 120 Result confirmation ............................. 126, 150 Result deletion (automatic) .......................... 78 Result detention ............................................... 79 Result display mode ................................. 8485 Result login ............................................ 125, 149 Result memory ..................................7580, 169 Result unit .................................................... 8183 Review results ....................................... 169182 All results .................................................. 172 Data transfer ............................................ 177 IQC (instrument quality control) ....... 174 Maintenance ............................................ 175 Patient history .......................................... 171 QC (quality control) ............................... 173 RF (radio frequency) ..............................24, 210 S Safety Protection against infection ................. 17 User qualification ..................................... 17 Sample material .................................... 129, 198 Scan (button) ......................................... 136, 142 Self-check (powering on the meter) ...... 134 Software license ............................................. 201 Sound ............................................................ 6264 Specifications .................................................. 197 Start info ............................................................ 125 STAT test ........................................................... 108 Configure .................................................. 122 Perform ...................................................... 153 Storage ............................................................... 183 Storage and transport conditions ............ 198 Symbols Code chip ........................................ 144, 160 Error messages ....................................... 193 Hourglass ........................................ 147, 163 Meter ...............................................................5 Packaging ......................................................5 Pipette .............................................. 145, 161 Screen ................................................... 3335 Thermometer ................................. 144, 161 Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 223 (228) 223 This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 224 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 224 (228) This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 225 (228) 225 This page intentionally left blank. Print Date:
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Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential 226 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 226 (228) Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 227 (228) ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche. Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.cobas.com Print Date:
Print Comment:
Title: cobas_h232_OM_v7_07469101001_04_EN Version: 05 Confidentiality: Confidential N E 1 1
2 2 0 2
) 4 0
1 0 0 1 0 1 9 6 4 7 0 Status: Signed Document Number: 0000000000001200000160397 Valid from: 24-Jan-2023 09:31:11 (UTC) Content Page 228 (228)
1 2 | Users Manual - Regulatory Information | Users Manual | 882.71 KiB | December 11 2023 |
This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use. Diese Kopie wird nicht aktualisiert. berprfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE Ansprechpartner. Esta copia no va a ser actualizada. Verifique el status de esta versin en DiaDoc o contacte a su representante de ROCHE antes de utilizarla. Document Information:
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Wallace, Barbara {DSSD~Mannheim}
Global Platforms & Support Confidential Device Master Record Device Master Record Wallace, Barbara {DSSD~Mannheim}
Effective 02-Aug-2022 11:14:23 (UTC) cobas_h232_WLAN_Add_V3_07787421001-03_ML 0000000000001200000371600 02 No Product Documentation Operators Manual Mannheim Global Customer Support cobas_h232_WLAN_Addendum_V3_07787421001-03_ML 07787421001 Updated registration information for Indonesia. Not printed, available for download via www.cobas.com Electronic Signatures:
Signed By:
Role:
Signature Differentiation:
Signed Date:
lindenc1 (Christine Baumann {DQRAC}) Reviewer Regulatory Affairs 01-Aug-2022 10:40:23 (UTC) Signed By:
Role:
Signature Differentiation:
Signed Date:
pfistes1 (Sonja Pfister {DSSPP}) Reviewer Global Customer Support 27-Jul-2022 05:48:24 (UTC) Signed By:
Role:
Signature Differentiation:
Signed Date:
kratzc (Christian Kratz {DSRPIV}) Reviewer R and D 27-Jul-2022 05:22:11 (UTC) Signed By:
Role:
Signature Differentiation:
Signed Date:
galinkig (Galina Galinkina {DSPCA}) Approver International Product Manager - IPM 02-Aug-2022 08:22:48 (UTC) Signed By:
Role:
wallacb5 (Barbara Wallace {DSSDPA}) Approver Title: cobas_h232_WLAN_Add_V3_07787421001-03_ML Version: 02 Confidentiality: Confidential Print Date:
Print Comment:
Status: Effective Document Number: 0000000000001200000371600 Valid from: 02-Aug-2022 11:14:23 (UTC) Cover Page 1 (2) This copy will not be updated. Verify the status of this version in DiaDoc or contact your ROCHE representative prior to use. Diese Kopie wird nicht aktualisiert. berprfen Sie vor Gebrauch den Status dieser Version im DiaDoc oder kontaktieren Sie Ihren ROCHE Ansprechpartner. Esta copia no va a ser actualizada. Verifique el status de esta versin en DiaDoc o contacte a su representante de ROCHE antes de utilizarla. Signature Differentiation:
Signed Date:
Documentation Management 02-Aug-2022 10:57:40 (UTC) Title: cobas_h232_WLAN_Add_V3_07787421001-03_ML Version: 02 Confidentiality: Confidential Print Date:
Print Comment:
Status: Effective Document Number: 0000000000001200000371600 Valid from: 02-Aug-2022 11:14:23 (UTC) Cover Page 2 (2) WLAN Registration Information Addendum to the Operators Manual for the cobas h 232 meter This multilingual document contains information on WLAN registration in various countries. WLAN cobas h 232 WLAN Informace o registraci WLAN Dodatek kuivatelsk pruce pro systm cobas h 232 Tento vcejazyn dokument obsahuje informace o registraci WLAN vrznch zemch. WLAN registracijos informacija cobas h 232 vartotojo vadovo priedas iame daugiakalbiame dokumente pateikta informacija apie WLAN registracij vairiose alyse. WLAN-registreringsoplysninger Tillg til brugermanualen til cobas h 232-instrumentet Dette flersprogede dokument indeholder oplysninger om WLAN-
registrering i forskellige lande. Informationen zur WLAN-Registrierung Ergnzung zum Benutzerhandbuch fr das cobas h 232 Messgert Dieses mehrsprachige Dokument enthlt Informationen zur WLAN-
Registrierung in verschiedenen Lndern. WLAN cobas h 232 WLAN . Informacin de registro de WLAN Anexo para el Manual del usuario del medidor cobas h 232 Este documento multilinge contiene informacin sobre el registro de WLAN en varios pases. Informcija par WLAN reistrciju cobas h 232 lietotja rokasgrmatas pielikums aj vairks valods nodrointaj dokument ir sniegta informcija par WLAN reistrciju dads valsts. Informatie over WLAN-registratie Aanvulling op de Handleiding van de cobas h 232-meter Dit meertalige document bevat informatie m.b.t. WLAN-registratie in verschillende landen. Informasjon om WLAN-registrering Tillegg til bruksanvisningen for cobas h 232-apparatet Dette flersprklige dokumentet inneholder informasjon om WLAN-
registrering i ulike land. Informacje na temat rejestracji WLAN Dodatek do podrcznika operatora systemu cobas h 232 Ten wielojzyczny dokument zawiera informacje dotyczce rejestracji WLAN w rnych krajach. WLAN-i registreerimisteave Lisa kasutusjuhendile cobas h 232 See mitmekeelne dokument sisaldab teavet WLAN-i registreerimise kohta eri riikides. Informaes de registo WLAN Anexo ao Manual do operador do aparelho cobas h 232 Este documento multilingue contm informaes sobre o registo WLAN em vrios pases. WLAN-rekisterintitietoja Lisys cobas h 232 -mittarin kyttohjeeseen Tm monikielinen asiakirja sislt tietoa WLAN-rekisterinnist eri maissa. WLAN cobas h 232 WLAN . Informations denregistrement du WLAN Addendum pour le manuel de loprateur du lecteur cobas h 232 Ce document multilingue contient des informations concernant lenregistrement du WLAN dans divers pays. WLAN-regisztrlssal kapcsolatos informcik Kiegszts a cobas h 232 felhasznli kziknyvhez Ez a tbbnyelv dokumentum a klnbz orszgokban a WLAN-
regisztrlsra vonatkoz informcikat tartalmazza. Informazioni di registrazione alla WLAN Appendice al Manuale Operatore dello strumento di misurazione cobash 232 Questo documento in pi lingue contiene informazioni sulla registrazione alle reti WLAN in vari Paesi. Informcie o registrcii WLAN Dodatok k nvodu na obsluhu zariadenia cobas h 232 Tento viacjazyn dokument obsahuje informcie o registrcii WLAN vrznych krajinch. Information om WLAN-registrering Tillgg till anvndarhandboken fr cobas h 232-mtaren I det hr flersprkiga dokumentet finns information om WLAN-registrering i olika lnder. WLAN cobas h 232
/ WLAN Abu Dhabi/Dubai/United Arab. Emirates:
TRA REGISTERED No:
ER45024/16 DEALER No:
DA35187/14 Argentina:
CNC: C15843 India Approval No: NR-ETA/3107 Indonesia:
80514/SDPPl/2022 8908 Japan:
R 202-SMD095 T D 15-0037 202 Australia/ New Caledonia/New Zealand:
This device is granted pursuant to the Japanese Radio Law () and the Japanese Telecommunications Business Law (). This device should not be modified (otherwise the granted designation number will become invalid). The compliance mark indicates that the product complies with the applicable standard and establishes a traceable link between the equipment and the manufacturer, importer or their agent responsible for compliance and for placing it on the Australian and New Zealand market. Mexico:
La operacin de este equipo est sujeta a las siguientes dos condiciones:
(1) es posible que este equipo o dispositivo no cause interferencia perjudicial y (2) este equipo o dispositivo debe aceptar cualquier interferencia, incluyendo la que pueda causar su operacin no deseada. Brazil:
Pakistan:
4703155748
(01)07899074502670 Resolution n 506:
Este produto opera em carter secundrio, isto , no tem direito a proteo contra interferncia prejudicial, mesmo de estaes do mesmo tipo, e no pode causar interferncia a sistemas operando em carter primrio. SAR:
Este produto est homologado pela Anatel, de acordo com os procedimentos regulamentados pela Resoluo n. 242/2000 e atende aos requisitos tcnicos aplicados, incluindo os limites de exposio da Taxa de Absoro Especfica referente a campos eltricos, magnticos e eletromagnticos de radiofrequncia de acordo com as Resolues n. 303/2002 e 533/2009. Philippines:
NTC Type Approved No.: ESD-1612448C Anatel site information:
ANATEL - AGNCIA NACIONAL DE TELECOMUNICAES www.anatel.gov.br Print Date:
Print Comment:
Document version 3.0 - 0 7787421001 (03) 2022-08 ML Title: cobas_h232_WLAN_Add_V3_07787421001-03_ML Version: 02 Confidentiality: Confidential Status: Effective Document Number: 0000000000001200000371600 Valid from: 02-Aug-2022 11:14:23 (UTC) Content Page 1 (2) Russia:
Taiwan:
Vietnam:
Singapore:
Approved by IMDA for use in Singapore. N3894-15 NCC Warning Statement Administrative Regulations on Low Power Radio Waves Radiated Devices warning:
South Africa:
Article 12 Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteris-
tic as well as performance to a ap-
proved low power radio-frequency devices. The low power radio-frequency devices shall not influence aircraft security and interfere legal com-
munications; If found, the user shall cease operating immediately until no interference is achieved. The said legal communications means radio communications is operated in compliance with the Telecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal com-
munications or ISM radio wave radiated devices. Article 14 USA/Canada:
TA-2015/2343 South Korea:
B ( )
(B)
. MSIP-CRM-RPD-Cobas232 Print Date:
Print Comment:
Title: cobas_h232_WLAN_Add_V3_07787421001-03_ML Version: 02 Confidentiality: Confidential FCC and IC compliance (English) This device complies with Part 15 of the FCC Rules and with Industry Ca-
nada license-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 interfe-
rence that may cause undesired operation. FCC and IC compliance (French) Le prsent appareil est conforme aux CNR d'Industrie Canada applica-
bles 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 fonctio-
nnement. ROCHE CARDIAC, COBAS, COBAS H and IQC are trademarks of Roche. 2016-2022 Roche Diagnostics GmbH Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim, Germany www.roche.com www.cobas.com Status: Effective Document Number: 0000000000001200000371600 Valid from: 02-Aug-2022 11:14:23 (UTC) Content Page 2 (2)
1 2 | ID Label Location Info | ID Label/Location Info | 802.81 KiB | December 11 2023 |
WLAN Label cobas h 232 Draft EN_25x39 Schwarz cobas H 232 (2) Model Rev.: H232-HBM 4.5 FCC ID: VO9-H232 MSIP-CRM-RPD-Cobas232 IFETEL: RCPROCO15-2259 ANATEL: 4703-15-5748 IC ID: 3100B-H232 CMIIT ID: 2015DJ5735 CCAE15LP2740T6 0 7 7 X X X X X TA-2015/2343 C-26365
0 2
) R 202-SMD095 T D 15-0037 202
1 2 | 2.911(d)(5) Attestation Letter | Attestation Statements | 113.13 KiB | December 11 2023 |
Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Roche Diagnostics GmbH Sandhofer Strass 116 68305 Mannheim, Germany 16 October 2023 Attestation Statement according to 2.911(d)(5)(i) and 2.911(d)(5)(ii) VO9-H232 TO WHOM IT MAY CONCERN:
Hereby we certify that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Further we certify that, as of the date of the filing of the application, Roche Diagnostics is not identified on the Covered List as an entity producing covered equipment. Sincerely, Charaf Bnouachir Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim / Germany Phone: +4962175973268 Mobile: +4915254791415 Email:charaf.bnouachir@roche.com Roche Diagnostcs GmbH Diagnostics Division Sandhofer Strass 116 Mannheim, Germany DV&V 1/1
1 2 | 2.911(d)(7) Attestation Letter | Attestation Statements | 281.13 KiB | December 11 2023 |
Roche Diagnostics GmbH Sandhofer Strafe 116 D-68305 Mannheim Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Attestation Statement according to 2.911(d)(7) TO WHOM IT MAY CONCERN:
We, Roche Diagnostics GmbH with FCC Registration Number (FRN) 0016954943 designate C T Corporation System to act as U.S. agent for service of process. CT Corporation System (C T Corporation System does not do any business with FCC and therefore has nor own FRN) hereby acknowledges the obligation of the U.S. agent for service of process. Further Roche Diagnostics GmbH accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Roche Diagnostics GmbH Sandhofer StraRe 116 68305 Mannheim Sincerely
(signature & company stamp) Roche Diagnostics GmbH C T Corporation System Sandhofer Strafe 116; D-68305 Mannheim 1015 15* Street N.W., Suite 1000, Washington, Ralf Schmitz D.C., 20005
+49 621 7594104 Stephanie Hencz ralf.schmitz@roche.com 202-572-3133 CTSOPReceipt@wolterskluwer.vom R oche 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. Claudia Fleischer; Clemens Schmid -
Aufsichtsratsvorsitzender: Dr. Thomas Schinecker Confidentiality Note This message is intended only for the use of the named recipient(s) and may contain confidential and/or privileged information. If you are not the intended recipient, please contact the sender and delete the message. Any unauthorized use of the information contained in this message is prohibited.
1 2 | FCC Confidentiality Request | Cover Letter(s) | 998.61 KiB | December 11 2023 |
LONG-TERM CONFIDENTIALITY REQUEST for Certification Service in the USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 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 request Long-Term Confidentiality for the following product:
Grantee Code Equipment Product Code Check your GC here. Click Grantee Search. FCC ID:
For the product stated above, we request Long-Term Confidentiality for exhibits which contain Block Diagram, Operational Description, Parts List/Tune Up Info, Schematics, SDR Software/Security Info. The above exhibits contain our benefit to our competitors. This information will not be publicly available. trade secrets and proprietary information If you have any questions, please feel free to contact us at the address shown below. Sincerely, Company Name:
Company Address:
Contact Name:
Signature:
Phone:
Fax:
E-mail:
Signature Date:
that could be of Document Version 1.1 2020-10-30
1 2 | Original Applicant Authorization | Cover Letter(s) | 116.76 KiB | December 11 2023 |
Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Innovation, Science and Economic Development Canada 3701 Carling Ave. Bldg. 94 Ottawa, On K2H 8S2 2023-12-06 TO WHOM IT MAY CONCERN FCC ID: T7V-9026; IC: 216Q-9026, HVIN(s): ENWF9203A1EF / ENWF9208A1EF We the undersigned, hereby authorize Roche Diagnostics GmbH at Sandhofer Strasse 116, 68305 Mannheim, Germany to use the Schematics, Test Reports and Photos of the above-mentioned product for the purpose of the certification of new products. We are aware that all supported documents will be uploaded to the FCC- and ISED-databases and that the Test results will be public available there. Sincerely, Marcus Nottorf Team Leader Product Safety Panasonic Industrial Devices Europe GmbH Phone: +49 (0) 4131-899 435 E-Mail: Marcus.nottorf@eu.panasonic.com Sitz Lneburg Registergericht: Amtsgericht Lneburg, Abt. B Nr. 839 Geschftsfhrer: Robert Sippel PANASONIC INDUSTRIAL DEVICES EUROPE GmbH Zeppelinstrae 19 . 21337 Lneburg . Germany Phone +49 (0) 4131 899-0 Fax +49 (0) 4131 899-120 E-Mail: pideu@eu.panasonic.com www.pideu.panasonic.de
1 2 | Software Security Letter UNII | Cover Letter(s) | 89.83 KiB | December 11 2023 |
Software security for UNII Devices Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim, Germany To Whom It May Concern:
Product/Model/HVIN: cobas h232 / H232 / H232-HBM 4.5 FCC ID: VO9-H232 IC ID: 3100B-H232 SOFTWARE SECURITY REQUIREMENTS FOR U-NII DEVICES acc. to KDB 594280 SOFTWARE CONFIGURATION DESCRIPTION General Description 1 2
. Describe how any software/firmware updates for elements than can affect the devices RF parameters will be obtained, downloaded, validated and installed. For software that is accessed through manufacturers website or devices management system, describe the different levels of security as appropriate. The firmware for the RF-module is static and will not be changed
(original driver from manufacturer). External (3rd party) applications are not accepted on the device. Any Roche application updates are hash-
signed (SHA256). Describe the RF parameters that are modified by any software/firmware Diagnostics Division
. DSRPIV Bldg/Room 072 Roche Diagnostics GmbH Sandhofer Strae 116; D-68305 Mannheim; Telefon +49-621-759-0; Telefax +49-621-759-2890 Sitz der Gesellschaft: Mannheim - Registergericht: AG Mannheim HRB 3962 - Geschftsfhrung: Dr. Ursula Redeker, Sprecherin; Andreas Schmitz -
Aufsichtsratsvorsitzender: Dr. Thomas Schinecker 1/6 without any hardware changes. Are these parameters in some way limited such that any other software/firmware changes will not allow the device to exceed the authorized RF characteristics?
The firmware for the RF-module is static and will not be changed
(original driver from manufacturer) and will not be changed by the application. Describe in detail the authentication protocols that are in place to ensure that the source of the RF-related software/firmware is valid. Describe in detail how the RF-related software is protected against modification. Updates are signed by Roche certificate. Unauthorized update packages will not be accepted by the internal update process. Update software is provided by Roche solely. Describe in detail any encryption methods used to support the use of legitimate RF-related software/firmware. The firmware for the RF-module is static and will not be changed
(original driver from manufacturer). External (3rd party) applications are not accepted on the device. Any Roche application updates are hash-
signed (SHA256). For a device that can be configured as a master and client (with active or passive scanning), explain how the device ensures compliance for each mode? In particular if the device acts as master in some band of operation and client in another; how is compliance ensured in each band of operation?
3 4 5 N/A Third-Party Access Control 2/6 1 2 Explain if any third parties have the capability to operate a U.S.-sold device on any other regulatory domain, frequencies, or in any manner that may allow the device to operate in violation of the devices authorization if activated in the U.S. N/A Describe, if the device permits third-party software or firmware installation, what mechanisms are provided by the manufacturer to permit integration of such functions while ensuring that the RF parameters of the device cannot be operated outside its authorization for operation in the U.S. In the description include what controls and/or agreements are in place with providers of third-party functionality to ensure the devices underlying RF parameters are unchanged and how the manufacturer verifies the functionality. External (3rd party) applications are not accepted on the device. 3 For Certified Transmitter modular devices, describe how the module grantee ensures that host manufacturers fully comply with these software security requirements for U-NII devices. If the module is controlled through driver software loaded in the host, describe how the drivers are controlled and managed such that the modular transmitter RF parameters are not modified outside the grant of authorization. N/A SOFTWARE CONFIGURATION DESCRIPTION USER CONFIGURATION GUIDE 1 Describe the user configurations permitted through the UI. If different levels of access are permitted for professional installers, system integrators or end-users, describe the differences. 3/6 1.a What parameters are viewable and configurable by different parties?
SSID and Server-IP are read-only visible in the UI for every user. Any RFparameter are controlled by a remote server application within the customers environment. The remote server application is accessible for the authorized system administrator(s) only. 1.b What parameters are accessible or modifiable by the professional installer or system integrators?
SSID, passphrase, cypher-type and network parameters (such as IP adresses) are configurable by the remote server application, which is accessible for the authorized system administrator(s) only. 1.b(1) Are the parameters in some way limited, so that the installers will not enter parameters that exceed those authorized?
Put in your text here. 1.b(2) What controls exist that the user cannot operate the device outside its authorization in the U.S.?
All input values are checked against its predefined limits. No parameter can exceed its limits. 1.c What parameters are accessible or modifiable by the end-user?
SSID, passphrase, cypher-type and network parameters (such as IP adresses) are configurable by the end-user by using a remote server application, which is accessible for the authorized system administrator(s) only. 1.c(1) Are the parameters in some way limited, so that the user or installers will not enter parameters that exceed those authorized?
Any transmitted parameter will be validated by the instruments 4/6 application and will only be accepted if inside of the authorized limits. 1.c(2) What controls exist so that the user cannot operate the device outside its authorization in the U.S.?
Any transmitted parameter will be validated by the instruments application and will only be accepted if inside of the authorized limits. 1.d Is the country code factory set? Can it be changed in the UI?
The instrument does not have a country code factory set. All parameter ranges per default valid for authorization in US, e.g. only authorized frequency bands are used. 1.d(1) If it can be changed, what controls exist to ensure that the device can only operate within its authorization in the U.S.?
A country code cannot be changed, as it does not exist. 1.e What are the default parameters when the device is restarted?
2 3 RF is deactivated. If activating RF only authorized frequency bands are usable. Can the radio be configured in bridge or mesh mode? If yes, an attestation may be required. Further information is available in KDB Publication 905462 D02. The instrument cannot operate in bridge or mesh mode as it is a passive device. For a device that can be configured as a master and client (with active or passive scanning), if this is user configurable, describe what controls exist, within the UI, to ensure compliance for each mode. If the device acts as a master in some bands and client in others, how is this configured to ensure compliance?
5/6 n/a (The instrument cannot operate in bridge or mesh mode) 4 For a device that can be configured as different types of access points, such as point-to-point or point-to-multipoint, and use different types of antennas, describe what controls exist to ensure compliance with applicable limits and the proper antenna is used for each mode of operation. (See Section 15.407(a)) The device cannot be configured as an access point as it is a passive device. Charaf Bnouachir, FPL Design Verification Roche Diagnostics GmbH Sandhofer Strasse 1156 D-68305 Mannheim; Telefon +49-621-759-0; Telefax +49-621-759-2890 6/6
1 2 | U-NII Device Declaration Letter | Cover Letter(s) | 1.73 MiB | December 11 2023 |
U-NII Device Declaration Letter Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Certification and Engineering Bureau Innovation, Science and Economic Development Canada Spectrum Engineering Branch 3701 Carling Avenue, Building 94 Ottawa, Ontario K2H 8S2 TO WHOM IT MAY CONCERN We herewith declare for our module with the following ID(s):
Grantee Code Equipment Product Code Check your GC here. Click Grantee Search. Check your CN here. FCC ID:
CN:
(Company Number) HVIN:
(Hardware Version Id. Number) HMN:
(Host Marketing Name) UPN:
(Unique Product Number) PMN:
(Product Marketing Name) FVIN:
(Firmware Version Id. Number) 1. Device functionality WLAN 2.4 GHz
(2400 - 2483.5 MHz) WLAN 5 GHz DFS: U-NII 2A & 2C
(5250 - 5350 MHz & 5470 - 5725 MHz) WLAN 5 GHz Non-DFS: U-NII 1 & 3)
(5150 - 5250 MHz & 5725 - 5850 MHz) Master N/A Master N/A Master N/A Client (slave) Client (slave) with radar detection Client (slave) without radar detection Client (slave) According to 15.202, KDB 905462, RSS-247, respectively:
A master device is defined as a device operating in a mode in which it has the capability to transmit without receiving an enabling signal. In this mode it is able to select a channel and initiate a network by sending enabling signals to other devices. A client (slave) device is defined as a device operating in a mode in which the transmissions of the device are under control of the master. A device in client mode cannot initiate, or be configured to initiate, any transmissions including transmissions from probes, beacons or support ad-hoc modes (or other peer to peer modes) of operation without permission from an approved master device with radar detection capability. 2. Operating modes Frequency
(MHz) Active scanning:
the device can transmit a probe
(beacon) Passive scanning:
the device can listen only with no probes Ad-hoc mode capability Access point capability 2400 - 2483.5 Yes Yes 5150 - 5250 Yes 5250 - 5350 Yes 5470 - 5725 Yes 5725 - 5850 No No No No No Yes Yes Yes Yes Yes No No No No No Yes Yes Yes Yes Yes No No No No No Yes Yes Yes Yes Yes No No No No No Info:
DFS bands marked in blue. Dynamic Frequency Selection (DFS) is a mechanism that dynamically detects signals from other systems and avoids co-channel operation with these systems, notably radar systems. DFS requirements to a master/client device are described in 15.407, RSS-247, respectively. 3. Miscellaneous Has the device the option to set or select country codes or permit similar configuration options through software parameters for different regulatory domains to configure the device transmitter power or frequency or other technical parameters by end users or professional installers (see KDB 594280 D01, IV.A.)?
Is the device capable of operating in channel 12 and 13?
Is the device capable of transmitting in the band 5600 - 5650 MHz?
Yes No Yes No Yes No If you have any questions, please feel free to contact us at the address shown below. Best regards, Company Name:
Company Address:
Contact Name:
Signature:
Phone:
Fax:
E-mail:
Signature Date:
Document Version 1.1 2023-07-31
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-12-11 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
2 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2023-12-11
|
||||
1 2 | Applicant's complete, legal business name |
Roche Diagnostics GmbH
|
||||
1 2 | FCC Registration Number (FRN) |
0016954943
|
||||
1 2 | Physical Address |
Sandhofer Strasse 116
|
||||
1 2 |
Mannheim, N/A
|
|||||
1 2 |
Germany
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
T******@ctcadvanced.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
VO9
|
||||
1 2 | Equipment Product Code |
H232
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
C**** P****
|
||||
1 2 | Telephone Number |
+4962******** Extension:
|
||||
1 2 | Fax Number |
+4962********
|
||||
1 2 |
c******@roche.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | 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 | 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?: | No | ||||
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 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood measuring instrument | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Original Equipment | ||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 | 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 | Grant Comments | Output power listed is conducted. This device supports IEEE 802.11b (Wi-Fi 1) with a 20 MHz bandwidth mode, IEEE 802.11g (Wi-Fi 3) with a 20 MHz bandwidth mode and IEEE 802.11n (Wi-Fi 4) with a 20 MHz, 40 MHz bandwidth mode. For body worn operation, this device has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal and that positions the handset a minimum of 0 mm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. End users must be informed of the body worn requirements for satisfying RF exposure compliance. The highest reported SAR for body-worn accessory and extremities are 0.47 W/kg, and 0.16 W/kg, respectively. | ||||
1 2 | Output power listed is conducted. This device supports IEEE 802.11a (Wi-Fi 2) with a 20 MHz bandwidth mode, IEEE 802.11n (Wi-Fi 4) with a 20 MHz, 40 MHz bandwidth mode and IEEE 802.11ac (Wi-Fi 5) with a 20 MHz, 40 MHz bandwidth mode. For body worn operation, this device has been tested and meets FCC RF exposure guidelines when used with an accessory that contains no metal and that positions the handset a minimum of 0 mm from the body. Use of other accessories may not ensure compliance with FCC RF exposure guidelines. End users must be informed of the body worn requirements for satisfying RF exposure compliance. The highest reported SAR for body-worn accessory and extremities are 0.47 W/kg, and 0.16 W/kg, respectively. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | 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 | Firm Name |
cetecom advanced GmbH
|
||||
1 2 | Name |
G**** S********
|
||||
1 2 | Telephone Number |
49-68********
|
||||
1 2 | Fax Number |
49-68********
|
||||
1 2 |
g******@cetecomadvanced.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2412.00000000 | 2462.00000000 | 0.0110000 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15E | ND | 5180 | 5240 | 0.013 | |||||||||||||||||||||||||||||||||||
2 | 2 | 15E | ND | 5745 | 5825 | 0.005 |
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