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User manual Part 1 | Users Manual | 5.46 MiB | December 17 2021 | |||
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1 2 3 | User manual Part 1 | Users Manual | 5.46 MiB | December 17 2021 |
cobaspulse User Assistance Publication version 1.0 Software version 01.03 2 Publication information Publication version Software version Revision date Change description 1.0 01.03 July 2021 First edition y Revision history Material number 09515909018 Edition notice This publication is intended for users of cobaspulse. Every effort has been made to ensure that all the information contained in this publication is correct at the time of publishing. However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication. General attention To avoid serious or fatal injury, ensure that you are familiar with the system and safety information before you use the system. r Pay particular attention to all safety precautions. r Always follow the instructions in this publication. r Do not use the instrument in a way that is not described in this publication. r Store all publications in a safe and easily accessible place. Instrument use The FDA, CDC, and CMS recommend the following:
r Point of Care blood testing devices such as the cobaspulse instrument should be used only on one patient and not shared. r If dedicating blood glucose instruments to a single patient is not possible, the instruments must be properly cleaned and disinfected after every use following the guidelines provided in this manual (see the Maintenance section). Images The images in this publication have been added exclusively for illustration purposes. Configurable and variable data in screenshots, such as tests, results, or path names visible therein must not be used for healthcare facility purposes. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Open-source and commercial software 3 Warranty Any customer modification to the instrument renders the warranty or service agreement null and void. For conditions of warranty, contact your local sales representative or refer to your warranty contract partner. Limited warranty PLACEHOLDER Copyright 20202021, Roche Diagnostics. All rights reserved. License information The cobaspulse instrument software is protected by contract law, copyright law, and international treaties. The cobaspulse instrument software contains a user license between F. Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access the software and use it. Unauthorized use and distribution may result in civil and criminal penalties. 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 manufacturer at the following address:
Roche Diagnostics GmbH Sandhofer Str. 116 68305 Mannheim Germany This open-source and commercial software and cobaspulse as a whole can constitute a device regulated in accordance with applicable law. For more detailed information, refer to the corresponding user documentation and labeling. Note that the respective authorization is no longer valid according to the corresponding legislation should any unauthorized changes be made to cobaspulse. Trademarks The following trademarks are acknowledged:
COBAS and COBAS INFINITY are trademarks of Roche. All other trademarks are the property of their respective owners. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 4 Feedback Every effort has been made to ensure that this publication fulfills the intended use. All feedback on any aspect of this publication is welcome and is considered during updates. Contact your Roche representative, should you have any such feedback. Approvals cobaspulse meets the requirements laid down in:
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. 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 available on the market of radio equipment and repealing Directive 1999/5/EC. To view the full text of the 2014/53/EU declaration of conformity, go to the Roche DiaLog global website
(dialogportal.roche.com) and choose the eLabDoc link. If you are unable to access Roche DiaLog, contact a Roche Service representative. Compliance with the applicable directives is provided by means of the declaration of conformity. The following marks demonstrate compliance:
For in vitro diagnostic use. The system fulfills the Canadian and U.S. safety requirements (UL LISTED, in accordance with UL 61010-1 and CAN/CSA-C22.2 No. 61010-1). This device contains license-exempt transmitter(s)/
receiver(s) that comply with Innovation, Science and Economic Development Canadas license-exempt RSS(s), and complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. This device may not cause harmful interference 2. This device must accept any interference received, including interference that may cause undesired operation of the device. FIPS PLACEHOLDER Validated under Federal Information Processing Standard (FIPS) 140-3, Security Requirements for Cryptographic Modules. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Contact addresses 5 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany Distributed in the U.S.A. by:
Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 Roche affiliates A list of all Roche affiliates can be found at:
www.roche.com/about/business/roche_worldwide.htm eLabDoc Electronic user documentation can be downloaded using the eLabDoc e-service on Roche Dialog:
dialogportal.roche.com For more information, contact your local affiliate or Roche Service representative. Additional help For all questions about the cobaspulse system that are not answered in this publication, contact the Roche Customer Support Center at 1-800-440-3638 24 hours a day, 365 days a year. In order to expedite troubleshooting, please have ready your instrument and all related consumables when you call. Rx only Caution: Federal law restricts this device to sale by or on the order of a physician. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 6 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 7 Table of contents Publication information Contact addresses Intended use Symbols and abbreviations Safety 1 General safety information Safety classifications Safety precautions Warning messages Caution messages Notices Safety information for disposal Recommendations for cybersecurity and data security System description Overview of the system About the system About the instrument Overview of the charging station Overview of the carry case Overview of the user interface About tests About lockouts List of notifications Overview of the User Assistance Specifications General specifications Technical specifications Environmental conditions Dimensions and weights List of accessories and consumables Barcode specifications Radio equipment specifications Operation Frequently performed tasks Logging on to the Glucose app Charging the instrument Checking notifications Putting the instrument into standby mode Waking the instrument from standby mode Logging off the Glucose app Routine operation Entering a patient Performing a glucose test Reviewing patient test results Performing a QC test 2 3 4 5 2 5 9 9 17 18 20 22 24 25 26 35 37 39 40 41 49 66 72 75 85 86 87 88 89 90 93 99 104 105 107 108 109 113 116 120 122 6 8 9 Reviewing QC test results Adding comments to a test result 126 128 Non-routine operation 131 Entering insulin information 135 Performing a linearity test 139 Performing an emergency glucose test Performing a proficiency test 142 Performing an observed test sequence (OTS) 145 Adjusting the screen brightness and the volume level Reviewing the audit trail Changing your user password Turning on the instrument Turning off the instrument Restarting the instrument Setting up the charging station Lot management 147 148 150 151 152 153 154 155 Maintenance 7 Maintenance About cleaning and disinfecting the instrument Acceptable cleaning solutions and disinfectants Cleaning and disinfecting the instrument Cleaning and disinfecting the charging station Cleaning and disinfecting the carry case Replacing the battery Troubleshooting Troubleshooting Resetting the instrument Running a network status test Network status test steps Resetting a synchronization lockout Deleting instrument data List of audit trail events Starting up an instrument with low battery level Error messages About level 1 messages and level 2 errors Level 1 messages Level 2 errors 169 171 172 175 176 177 185 186 188 190 191 192 193 209 213 229 Configuration 10 Initial configuration About instrument configuration About the Settings menu access restrictions Setting the instrument date and time 365 367 368 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 8 Table of contents Configuring by barcode Formats and language configuration QC configuration Data deletion Barcode camera configuration Connectivity 11 General configuration List of power management options Patient ID handling User ID handling Result range handling Measurement workflow Generic instrument functionality Glossary Index 370 371 376 385 388 390 425 427 437 448 458 467 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Intended use 9 cobaspulse is intended for multiple-patient use within professional healthcare settings, including intensive critical care and non-critical care settings. This system is not for screening or diagnosis of diabetes, but is indicated for use in determining dysglycemia. Symbols and abbreviations Product names Except where the context clearly indicated otherwise, the following product names and descriptors are used. Symbols used in the publication Symbol Explanation Product name cobaspulsesystem cobaspulse cobaspulse charging station cobaspulse carry case cobasGLU test strips cobasGLU QC kit cobasGLU linearity kit cobasinfinity POC solution y Product names and descriptors charging station Descriptor system instrument carry case test strips QC kit linearity kit iDMS o u w y z k List item Cross-reference to another topic Figure, used in figure titles and cross-
references to figures Table, used in table titles and cross-
references to tables Equation, used in cross-references to equations Code example, used in code titles and cross-
references to codes Tip, used for extra information on correct use or for useful hints Extra information within a task Result of an action within a task Frequency of a task Duration of a task y Symbols used in the publication Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 10 Symbols used on product and packaging Symbol Explanation Materials that are required for a task Prerequisites of a task y Symbols used in the publication Symbol Explanation Manufacturer. Date of manufacture. Catalog number. In vitro diagnostic medical device. Global Trade Item Number. Serial number. Unique device identifier TV SD U7-2D Biohazardous RFID reader. Device contains a transmitter. Device for near-patient testing y Symbols used on product and packaging Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 11 Symbol Explanation Device not for self-testing Temperature limitation Humidity limitation Refer to safety information included in this publication. Consult the instructions for use. y Symbols used on product and packaging Abbreviations The following abbreviations are used:
Abbreviation Definition Alternating current Direct current DHCP Dynamic host configuration protocol AC DC DMS DNS EAP EC EMC EN FCC IC IEC ISM ISO OTE OTS RF RFID RSS SAR TLS Data management system Domain name system Extensible authentication protocol European Community Electromagnetic compatibility European standard Federal Communications Commission (USA) Industry Canada International Electrotechnical Commission Industrial, scientific and medical International Organization for Standardization Other test entry Observed test sequence Radio frequency Radio frequency identification Radio Standards Specification (Canada) Specific absorption ratio Transport layer security WLAN Wireless local area network y Abbreviations Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 12 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Safety 1 General safety information ........................................................................ 15 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 15 General safety information In this chapter Safety classifications............................................................. Safety precautions ................................................................. Warning messages ................................................................ Caution messages ................................................................. Notices ....................................................................................... Safety information for disposal ......................................... Recommendations for cybersecurity and data security....................................................................................... 1 17 18 20 22 24 25 26 n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 16 Table of contents Page intentionally left blank. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General safety information 17 Safety classifications The safety precautions and important user notes are classified according to the applicable standards. Familiarize yourself with the following meanings and icons:
Safety alert r The safety alert symbol is used to alert you to potential physical injury hazards. Obey all safety messages that follow this symbol to avoid possible damage to the system, injury, or death. These symbols and signal words are used for specific hazards:
r indicates a hazardous situation that, if not avoided, could result in death or serious injury. r indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. WARNING!
Warning CAUTION!
Caution NOTICE!
Notice... r ...indicates a hazardous situation which, if not avoided, may result in damage to the system. Important information that is not safety relevant is indicated with the following icon:
i Tip... ..indicates additional information on correct use or useful tips. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 18 Safety precautions Safety precautions User qualification Insufficient knowledge and skills Safe and proper use of the system Non-approved parts Electromagnetic compatibility (EMC) n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 To avoid serious or fatal injury, read and comply with the following safety precautions. To ensure correct operation of cobaspulse:
r Only trained healthcare professionals may operate the instrument. r Users must have received comprehensive instruction in the operation, QC, and care of cobaspulse. Use of non-approved parts or devices may result in malfunction of the system and may render the warranty null and void. r Use only parts and devices approved by Roche Diagnostics. The system complies with the emission and immunity requirements described in IEC 61326-2-6. It has been designed and tested to CISPR 11 Class B. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference. The electromagnetic environment in which the cobaspulse system will be operated should be thoroughly evaluated prior to operation of the device. 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 interference to radio or television reception, which can be determined by powering the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Electrostatic discharge (ESD) Wireless connectivity Radio frequency radiation exposure information General safety information 19 Consult the dealer or an experienced radio/TV technician for help. cobaspulse complies with both the electromagnetic immunity requirements and radio interference immunity requirements at the frequency and test levels according to ISO 15197. The cobaspulse system complies with the electrostatic discharge (ESD) immunity requirements as specified in IEC 61326-2-6. Electrostatic discharge (ESD) is an electrical charge at rest, most commonly known as static electricity. If the meter experiences ESD during a blood glucose test, an error message is displayed and no blood glucose result is displayed by the meter or stored in the meters memory. The blood glucose test will need to be repeated. To avoid ESD, do not use the meter in a very dry environment, particularly one in which synthetic materials (e.g., carpets) are present that might cause damaging static discharges. Wireless connectivity allows the instrument to send data
(test results, patient IDs, user IDs, etc.) to the data management system. The Wi-Fi should be configured by the system administrator. Observe the guidelines of your facility for using wireless local area network connections. For additional information contact Roche Customer Support Center for technical assistance. The industrial, scientific and medical (ISM) radio frequencies may contain emissions from microwave ovens, heaters, and other non-communication 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 enabled device. 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. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 20 Warning messages Warning messages Incorrect test measurement To avoid harmful outcomes resulting from incorrect test measurements, ensure the following:
List of warning messages Failure to observe warning messages may result in death or serious injury. r Before using the system, read the warning messages carefully. r Only use a blood sample when performing a test measuring blood glucose. r Only use an appropriate QC material when performing QC tests. r Always wear a new, clean pair of disposable gloves for each test you perform. r Use only parts and devices approved by Roche Diagnostics. r Do not use the instrument outside the specified temperature range. r Do not use the instrument in a hyperbaric chamber. r Ensure that there are no traces of food on the fingers or fatty residues from hand cremes or soap products that may contaminate the sample. r Ensure that there are no residues of water or disinfectant on the skin that can dilute the drop of blood. r Test strips are single use only. Never reuse a test strip. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Protection against infection and blood-borne pathogens Avoiding electrical shock, fire, and explosions Risk of barcode read errors General safety information 21 Healthcare professionals using cobaspulse to perform tests must be aware that any object coming into contact with human blood is a potential source of infection. Users must adhere to standard precautions when handling or using cobaspulse. 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. r Use disposable gloves. Wear a new pair of clean gloves for testing each patient. r Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next test. r Use an auto disabling single-use lancing device for each patient. r Dispose of used lancets in a solid waste/sharps container with lid. r Dispose of used test strips from patient and proficiency tests according to your healthcare facilitys infection control policy. r Follow all health and safety regulations in force locally. r Only use Roche original accessories (cables, power supplies, batteries). Third-party cables, power supplies, and batteries can cause the battery to explode or the instrument to become damaged. r Do not use loose power outlets or damaged power supplies, cables, plugs, or batteries. r Do not short circuit the power supplies or the battery. r Do not drop the instrument, charging station, the power supplies, or the battery, and protect them against shaking and vibrations. If a barcode is read incorrectly, it may lead to patient misidentification and inappropriate therapy decisions. r When creating patient or user barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode symbology. r Ensure that barcode size and print quality (as defined in ISO/IEC 15416 and 15415) are adequate. r Carry out a plausibility check on all data scanned into and displayed by the instrument. u Barcode specifications (90) n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 22 Caution messages Caution messages Allergy or injury caused by reagents and other working solutions Safety information for barcode camera and built-in flashlight Exposure to the barcode reader flashlight many be harmful to the eyes Unauthorized system access and data loss List of caution messages r Before operating, read the caution messages carefully. Failure to observe them may result in minor or moderate injury. Direct contact with reagents, detergents, cleaning solutions, disinfectants or other working solutions may cause skin irritation or inflammation. r Always wear disposable gloves. r Observe the cautions given in the package inserts or healthcare facility instructions of the reagents, cleaning solutions and disinfectants. r If a reagent, QC material, or linearity material come into contact with your skin, wash it off immediately with water. r Do not look into the flash light when it is turned on. If the system is connected to a local area network, this network must be protected against unauthorized access. In particular, it must not be connected directly to any other network or the internet. Users are responsible for the security of their local area network, especially in protecting it against malicious software and attacks. Failure to do so may result in data loss or may render the system unusable. Roche recommends the following precautions:
r To protect access to all external devices, make sure that you use appropriate security equipment. For more information, contact your Roche Service representative. r Ensure that the connected network is free of malicious code. 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) n o i t a m r o f n i y t e f a s l a r e n e G 1 Strong password management Observe your facilitys guidelines on password management where available, or apply the following rules:
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General safety information 23 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. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 List of notices Failure to observe the notices may result in damage to the system. r Before using the system, read the notices carefully. General care Using cleaning solutions and disinfectants not specified in this publication may result in incorrect operation and possible failure of the instrument. r Only clean the instrument with the recommended cleaning solutions and disinfectants. r Ensure that the instrument and charging station are thoroughly dried after cleaning and disinfection. 24 Notices Notices n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General safety information 25 Safety information for disposal Disposal of the instrument Infection by a potentially biohazardous instrument. Disposal of electronic equipment r The instrument 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. r Dispose of the instrument or its components according to the appropriate local regulations or you may return it to Roche. For more information, contact your Roche representative. This symbol appears on any component of the system that is covered by the European Directive on waste electrical and electronic equipment (WEEE). You must dispose of these items through designated collection facilities appointed by government or local authorities. Contact your city office, waste disposal service, or your Roche Service representative for more information about disposal of your old product. Constraint:
It is left to the responsible organization to determine whether electronic equipment components are contaminated or not. If contaminated, treat them in the same way as the system. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 26 Recommendations for cybersecurity and data security Recommendations for cybersecurity and data security Physical access controls User authentication Potentially sensitive personal information may be stored on the instruments locally and transferred over the network. After results are sent to the DMS, they remain on the instrument. This is a patient safety measure enabling the user (such as a nurse) to look up previous patient measurement results when the network or DMS is unavailable. You should consider the following recommendations to prevent unauthorized access or manipulation of data. Ensure that the instruments are protected against unauthorized physical access and theft. Since Roche Point of Care instruments are hand-held, an unauthorized user might gain access to data by stealing an instrument, or attempting to interact with it. Protect access to the instrument by using one of the following:
Scanning a valid users barcode or RFID tag, and entering the users password using the virtual keyboard. Entering a user name and password using the virtual keyboard.
(see the User authentication required and User ID validation configuration items). Include user certificate expiry dates in the DMS (see the Show user lockout warning prior to user certificate expiration configuration item). Passwords are the most important access control on the instrument. Users often use the same password for multiple accounts making it easier for an unauthorized person to gain access. Therefore, use strong passwords and do not share accounts. Set an appropriate value for the minimum password length which is enforced when users set their password
(see the Minimum password length configuration item). n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General safety information 27 Delete users who are no longer needed on the instruments and use the "standby timeout" function for automatic logout on inactivity (see the Standby timeout and Logon session timeout configuration items). Ensure that users log off the instrument when they have finished using it (see User log off). When using user lists with passwords in combination with a DMS (see the User ID validation configuration item), the instrument has the following options for user passwords:
Upload user lists with configured passwords Upload user lists with empty passwords The user list with configured passwords is active once uploaded to the instrument. For user lists with empty passwords, users are prompted to enter a new password when they first log on. Ensure that users set their password immediately on an instrument. This measure ensures that the password is synchronized with the DMS and distributed to all available instruments. u Strong password management (22) u User authentication required (437) u User ID validation (439) u User ID handling (444) u Standby timeout (425) Allow configuration by barcode on the Allow access to lot management on the instrument instrument, Allow access to administrator features Access restrictions to date and time During the initial installation of an instrument, ensure that the Setup password is set accordingly. n o i t a m r o f n i y t e f a s l a r e n e G 1 Access restrictions for settings You should configure additional access restrictions to instrument menus based on your needs using the following configuration items:
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 28 Recommendations for cybersecurity and data security Secure network connections You should use WPA2 encryption to protect your data and wireless connection. Alternative connection methods
(e.g., open, WPA encryption) can be insecure and should only be used in exceptional cases. Secure network environment Ensure that the instrument date and time are synchronized with the date and time of IT systems to which it is connected (DMS, cobas infinity edge). Instruments with an incorrect date and time will experience connectivity issues. u Access restrictions (467) When connecting Roche Point of Care instruments to a local area network, the network must be protected against unauthorized access. It must be resilient to traffic redirection and eavesdropping. In particular, it must not be linked directly to any other network or the Internet. Protection includes measures such as a firewall to separate the instrument from uncontrolled networks, or measures to ensure that the connected network is free from malicious code. You can use EAP as a safety measure. This measure prevents an attacker behaving like a Roche Point of Care instrument within your network, when communicating with the DMS. You should use TLS encryption when communicating with the DMS (see the DMS TLS level, DMS TLS certificate check and DMS TLS certificate configuration items). u TLS security (414) Unused user accounts Delete the account of users who no longer use the instrument (including their related local data). Handling personal data You should inform users how to handle personal data. This measure should be compliant with your facilitys current regulations. For example:
Do not enter direct identifiers ( identifier which links directly to an individual) into free-text comments. Be aware of password security rules. Do not leave an instrument unlocked in publicly accessible areas. Authentication of communication end points
(use EAP and TLS) n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General safety information 29 Asset tracking controls Ensure that your facility implements controls to track instruments. Data retention time Adjust the instrument result retention time and the result deletion algorithm according to your facilitys current regulations. See the following configuration items:
Result Deletion Algorithm Result upload required before result deletion Result retention period (in days) Audit trail retention period (in days) u Data deletion (385) Data minimization options It is possible to use the instrument without any direct identifiers (e.g., names). The information which is uploaded to the instruments is defined in the DMS. Wiping data from the instrument Prior to disposal of an instrument, wipe the stored data using Settings > Administrator > Delete instrument data. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 30 Recommendations for cybersecurity and data security Page intentionally left blank. n o i t a m r o f n i y t e f a s l a r e n e G 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 System description 2 3 Overview of the system ............................................................................... 33 Specifications.................................................................................................. 83 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 33 Overview of the system In this chapter About the system ................................................................... About the instrument ........................................................... Overview of the charging station ..................................... Overview of the carry case ................................................. Overview of the user interface .......................................... Overview of the software ......................................... About the user interface .......................................... About the charging screen ..................................... About the Tests screen............................................. About the app library................................................. About the Glucose app start screen.................... About tests ............................................................................... About patient entry .................................................... About collecting a blood sample .......................... About performing a glucose test .......................... About glucose test results....................................... About performing QC tests ..................................... About proficiency testing......................................... About linearity testing............................................... About the observed test sequence (OTS) ......... About adding comments to a test result ........... About the test strip port light ................................. About lockouts........................................................................ About the QC lockout................................................ Lockout types ............................................................... List of notifications ................................................................ Overview of the User Assistance ..................................... About the User Assistance...................................... Overview of User Assistance functions .............. Accessing the User Assistance online................ 2 35 37 39 40 41 41 43 45 46 46 47 49 49 51 52 54 58 60 60 62 62 64 66 66 68 72 75 75 76 78 m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 34 Table of contents Accessing the User Assistance offline ............... Searching in the User Assistance......................... 79 80 m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 About the system Overview of the system 35 The cobaspulsesystem is a blood glucose monitoring system that allows healthcare professionals to measure blood glucose levels near the patient. The system can do the following:
Perform patient blood glucose tests and glucose QC tests with QC material. Record automatically information related to the performed tests. Record tests results and reagent information. Record data related to quality assurance. Transfer automatically all recorded information to the DMS. This system comprises the following components:
m e t s y s e h t f o w e i v r e v O 2 A Instrument B Charging station wSystem components C Carry case (may not be available in all countries) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 ABC 36 About the system System extension Through the app library, the system provides the option to extend its functionality by installing additional (Roche-
controlled) apps with other functionalities. u About the app library (46) Configuration options The system is highly-configurable. For that reason, some screens and procedures in your healthcare facility might differ slightly from the ones in this publication. Testing principle An enzyme on the test strip converts the glucose in the blood sample to gluconolactone. This reaction creates a harmless DC electrical current that the instrument interprets and converts into a blood glucose result. The sample and environmental conditions are also evaluated using AC and DC signals. For detailed information, refer to the test strip package insert. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 37 About the instrument A Charge indicator B Touch screen C On/off button D Test strip port and light E Battery compartment cover F Built-in flashlight G Barcode camera H Instrument information I RFID reader wMain instrument components front (left) and rear (right) The instrument has the following elements:
Charge indicator Touch screen On/off button Test strip port Status indicator that shows the status of the charging process. Enables you to interact with the instrument by tapping the appropriate interface elements on the screen. Turns the instrument on and off. Puts instrument into and out of standby mode. u Putting the instrument into standby mode (107) Port for test strip insertion. Lighting indicates test-strip-
related actions that should be taken. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 ABCDEFGIH 38 About the instrument Battery compartment cover Cover by which the battery is accessed. Barcode camera Built-in flashlight Instrument information You use the integrated barcode camera to do the following:
Read user and patient IDs Read test strip container Read QC material bottle barcodes barcodes Read Linearity material bottle barcodes Configure the instrument Illuminates the barcode for scanning. Contains the following information:
Approval symbols Regulatory symbols Safety symbols Instrument specific symbols Technical data Barcode linking to additional information The information is laser etched onto the instrument. u Publication information (2) u Symbols and abbreviations (9) RFID reader The RFID reader is used to read the following:
User IDs Patient IDs m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 39 Overview of the charging station The charging station enables you to charge the instrument when it is not being used. A Rear panel wCharging station B Access to power inlet The panel contains 2 holes which can be used to mount the charging station, on a wall for example. The power supply is attached at the rear of the charging station. To charge the instrument, you place it in the cradle. u Setting up the charging station (154) m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 AB 40 Overview of the carry case Overview of the carry case The carry case provides an area for storing and transporting consumables needed for performing blood glucose tests. The carry case may not be available in all countries. wCarry case m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 41 Overview of the user interface In this section Overview of the software(41) About the user interface(43) About the charging screen(45) About the Tests screen(46) About the app library(46) About the Glucose app start screen(47) Overview of the software The figure contains the software items. Instrument configuration and user rights determine what you can access on your instrument. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 42 Overview of the user interface m e t s y s e h t f o w e i v r e v O 2 wOverview of the cobas pulse software The Instrument configuration menu item contains the following sub menu items (not shown in the overview):
ID configuration QC interval Range configuration Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Glucose appTestsLocal resultsNotificationsSettingsGlucosePatient resultsQC statusBrightness andvolumeEmergencyQC resultsInstrument cleaning statusChange passwordQCInstrument synchro-nization statusLanguageLinearityInstrument memory statusDate and timeSet dateProficiencyUser recertification statusSet timeInsulinMessage of the dayLot managementOTSPersonal messageConfiguration bybarcodeAudit trailInstrumentinformationAboutStatisticsInstrument configurationNetwork configurationNetwork status testAdministratorResetsynchronizationlockoutDeleteinstrumentdataLegal information Overview of the system 43 About the user interface The user interface enables you to perform tasks on the instrument. The user interface layout reflects the workflows of the tasks that you perform on the instrument. A Status bar B App bar wUser interface C Navigation bar The user interface has 3 main components:
Status bar App bar Navigation bar Depending on the task your are performing, the navigation bar is not always displayed. For example, when you are performing a glucose test Status bar The status bar contains the following components:
Current date and time Synchronization warning Battery level The status bar does not interact with any of the tasks you perform, and is always visible. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Local resultsPatient resultsQC resultsJenny DoeUnknown patientJohn DoeJenny DoeGlucoseGlucoseGlucoseGlucoseRegular insulin99999999912345678901234567890123123123300991602 U22-Mar-2020, 16:3122-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2722-Mar-2020, 15:27mg/dLmg/dLmg/dLABC22-Mar-2020, 16:31 44 Overview of the user interface The synchronization warning icon displayed in the status bar indicates that the instrument has not synchronized data with the DMS. In particular, recently measured test results and new patients, and additionally events, updated user lists and changes to the instrument configuration. App bar The app bar contains a screen title, indicating the user interface submenu in which you are working, or the activity that you are performing. For example, glucose test, QC test, results. It also contains user interface elements with which you navigate between screens. Move to previous screen Close the current screen/dialog box Log off Navigation bar The navigation bar provides direct access to the 4 main activity areas of the user interface. It contains 4 buttons. Tests Local results Notifications Settings Glucose test QC test Emergency test Linearity test Proficiency test Insulin entry The button provides access to the available tests:
Depending on your instruments configuration, not all of the tests may be available. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 45 button provides access to the results that are The currently stored on the instrument Patient results QC results button provides access to the Notifications The screen which is used for the following:
Reminders (for example, QC test is due) Messages (for example, message of the day, personal messages) Logging cleaning A blue notification badge on the button (
) indicates that notifications require a response from you. After you have responded, the blue badge disappears. The button provides access to the Settings screen which contains options to manage different aspects of your instrument (for example, setting the date and time, brightness and volume). u List of notifications (72) The charging screen is displayed when the instrument is docked in the charging station. It contains the following information:
Battery level of the instrument. Lockout notifications if applicable (2 items maximum). Instrument name and/or ID if configured (top of screen). Site and location where the instrument is used if configured (bottom of screen). The battery level is indicated by a percentage value and a color coded battery indicator. The color coding is determined as follows:
Red = 15% and below Yellow =16% to 89%
Green = 90% and above The battery indicator color corresponds with the instruments charge indicator color. m e t s y s e h t f o w e i v r e v O 2 About the charging screen Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 QC lockoutSynchronization lockoutLocationSiteInstrument name / ID 46 Overview of the user interface About the Tests screen The Tests screen contains the tests that are available for use, and indicates who is logged on to the Glucose app. You access the Tests screen in 2 ways:
When you log on to the Glucose app. On the navigation bar, by tapping the button. Each test is represented by a button. The following tests can be configured to be on the Tests screen:
Glucose test QC test test Emergency test Linearity test Proficiency test Insulin entry OTS (observed test sequence) i When there are more than 6 tests available, scroll the screen to view them all. To perform a test, you tap the corresponding button. icon on a test button indicates that the test cannot A be performed due to a lockout. You must remove the lockout before a test can be run. Tapping the test button displays a dialog box that provides guidance on what you must do to remove the lockout. When you have finished working in the Glucose app, you can log off by tapping the button. u About lockouts (66) The app library contains the apps that you can use on the instrument. m e t s y s e h t f o w e i v r e v O 2 About the app library Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Jenny Doe (1234567890)GlucoseQCEmergencyInsulinProficiencyLinearityTests Overview of the system 47 Depending on your instruments configuration, the app library is accessible as follows:
From the Glucose screen by tapping the app library button. Directly when you log on. There are 2 categories of apps:
Apps of the cobas pulse system Other apps Apps of the cobas pulse system are those which are provided with cobas pulse, including the Glucose app. Other apps are provided by Roche or by third parties. Your healthcare facility determines which apps are in the app library. You use cobas pulse dedicated apps to perform tests. Depending on your instruments configuration, you can log on to the in the Glucose app using the Glucose screen. Depending on how your instrument is configured, the Glucose screen is accessible as follows:
When you exit standby mode, or when you turn on When you take the instrument out of the charging the instrument. station. From the app library by tapping the Glucose app. How you log on depends on your instruments configuration:
If a user ID and password is required, tap the Log on button, and then follow the logon procedure. If a user ID only is required, tap the Log on button, and then follow the logon procedure. If a user ID and password is not required, tap the Proceed button which takes you directly to the Tests screen. The Glucose screen displays lockout notifications. Up to 5 items can be displayed. m e t s y s e h t f o w e i v r e v O 2 About the Glucose app start screen Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 GlucoseQC lockoutLog onApp libraryInstrument name / IDSiteLocation 48 Overview of the user interface The Glucose screen can be configured to display the following:
Instrument name and/or ID (top of screen). Site and location where the instrument is used
(bottom of screen). m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 About tests About patient entry Overview of the system 49 In this section About patient entry(49) About collecting a blood sample(51) About performing a glucose test(52) About glucose test results(54) About performing QC tests(58) About proficiency testing(60) About linearity testing(60) About the observed test sequence (OTS)(62) About adding comments to a test result(62) About the test strip port light(64) The way in which your instrument manages patient IDs depends on how it has been configured. You enter patients in the following tests:
The following configurations can be made to your instrument, and determine how it manages patient entry. Glucose test Insulin entry OTS Entry methods Autocomplete ID pattern recognition ID validation Confirmation Entry methods The entry methods are:
RFID tag Barcode scanning Keyboard entry Your instrument can be configured to determine which entry methods you can use. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 50 About tests Patient ID entry by keyboard can be configured to be any combination of up to 20 alphanumeric characters, with specified minimum and maximum lengths. Patient entry by barcode scanning only works using supported barcode types. u Barcode specifications (90) Autocomplete When configured, autocomplete provides a quick way to enter a patient when using keyboard entry. After entering 2 alphanumeric characters in the Patient name or patient ID field, a drop-down list is displayed. It contains all patient names or IDs containing the same 2 alphanumeric character sequence. You then select the patient from the drop-down list. i When entering a patient with autocomplete activated, case sensitivity does not apply. When autocomplete is not activated you must enter the patient ID in full using the correct capitalization. m e t s y s e h t f o w e i v r e v O 2 ID pattern recognition Your instrument can be configured to validate a configured pattern in a patient ID. For example, a pattern is configured so that all patient IDs begin with "PA" followed by 6 numerals. In this case, when entering a patient ID by keyboard:
"PA123456" is a valid patient ID.
"P123456" is an invalid patient ID. The same function operates for patient ID entry by barcode scanning. ID validation Your instrument can be configured to validate the patient ID entered in one of 3 ways. Pattern only List based List based. Allow new entries if not in list. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Enter patient name or patient ID Patient confirmation Your instrument can be configured to display the Confirm patient dialog box. It enables you to ensure that the patient that you entered is the correct patient. After confirming, you continue with the test. Overview of the system 51
"Pattern only" validation checks that the patient ID entered matches the configured patient ID pattern. For example, that the patient ID always starts with PA. If it does not, an error message is displayed.
"List based" validation checks that the patient ID entered matches an entry in the patient list on your instrument. If it does not, an error message is displayed.
"List based. Allow new entries if not in list" validation checks that the patient ID entered matches an entry on the patient list on your instrument. If the patient is not found, you are still able to enter the patient ID. This option caters for situations where a patient ID is in the DMS but has not been synchronized with your instrument. The Confirm patient dialog box contains the patient information that has been transmitted from the DMS to the instrument:
Patient name Patient ID Gender Age Date of birth The patient ID is mandatory. The other items are optional. u Related topics Performing a glucose test (116) Entering insulin information (131) You collect a blood sample from a patient in order to perform a blood glucose test. Prepare the selected puncture site and collect blood from the patient per healthcare facility policy. m e t s y s e h t f o w e i v r e v O 2 About collecting a blood sample Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Confirm patientPatient IDGenderAgeDate of birthConfirmCancel 52 About tests If no healthcare facility policy exists for collecting capillary blood, the patient's hands (or heel in the case of small children) should be thoroughly cleaned and dried. WARNING!
Incorrect results due to residues on skin Traces of food on the fingers or fatty residues from hand cremes or soap products may contaminate the sample and lead to incorrect results. Residues of water or disinfectant on the skin can dilute the drop of blood and lead to incorrect results. r Wash the puncture site thoroughly and rinse with plenty of water. r After washing and disinfecting the site, ensure that the patient's skin is completely dry before using the lancing device to collect a capillary blood sample. i You should take the capillary blood sample from the side of the fingertip as this part is the least sensitive to pain. u Related topics Performing a glucose test (116) The actions that you take when performing a glucose test depend on how your instrument is configured. The following steps in a glucose test are configurable:
ID confirmation Sample type selection Test trip ejection Comment handling Glucose test series Insulin entry About performing a glucose test m e t s y s e h t f o w e i v r e v O 2 Patient confirmation Your instrument can be configured so that you must confirm that the patient entered is correct. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 53 When configured, this occurs after you have entered the patient. The Confirm patient dialog box is displayed containing the following information:
Name Patient ID Gender Age Date of birth When you confirm that you have entered the correct patient you move to the next stage of the test. If it is not the correct patient you can cancel and then re-enter the patient. Sample type selection The Choose sample type screen contains the sample types that you can use in a glucose test. When enabled, you can select the sample type used in the glucose test. The available sample types are:
Capillary blood Venous blood Arterial blood Heel-stick blood Depending on how your instrument is configured, the Choose sample type screen is displayed after you enter the patient, or after confirming that the you have entered the correct patient. Test strip ejection The point in the glucose test at which the test strip is ejected from your instrument is configurable. Your instrument can be configured to eject the test strip before or after the test result confirmation. Comment handling When and how you add comments to a glucose test depends on your instruments configuration. Comment entry for glucose tests on the instrument can be configured as follows:
Disabled Optionally required Always required m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Confirm patientPatient IDGenderAgeDate of birthConfirmCancel 54 About tests Required when a test result is above or below the configured result range limits. u About adding comments to a test result (62) Glucose test series Your instrument can be configured to perform consecutive tests for the same patient. When configured, the Options dialog box is displayed at the end of the first test and you can choose to repeat the glucose test. Since the patient is already selected, you start the second test by inserting a test strip. Insulin entry Your instrument can be configured to enter insulin information after a glucose test has been performed. When configured, the Options dialog box is displayed at the end of the first test and you can choose to enter the insulin information since the patient is already selected. After confirming the insulin entries, you return to the Tests screen. u Related topics Performing a glucose test (116) About adding comments to a test result (62) Adding comments to a test result (128) Entering insulin information (131) The information that is displayed in the glucose test result screen and the actions you take depends on how your instrument is configured. The Glucose test result screen is displayed after the blood sample has been measured. About glucose test results m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 55 A Patient details B Glucose test result C Comment wGlucose test result D Patient local results history E Test range details F Edit comments Patient details Displays the patient information that has been provided by the DMS:
Patient ID Patient name Gender Date of birth The patient ID is mandatory. The other 3 items are optional. Glucose test result A glucose test result is color coded, based on the values of the test result ranges with which your instrument is configured. i You can view the values of the test result ranges button. by tapping the The color coding used for the test result ranges is indicated in the figure. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Glucose testJohn DoeResultGlucoseBelow normal rangeNew test strip lotSample typeTest strip lot numberArterial bloodConfirmABDEF60mg/dLC03-Feb-197022-Mar-2020, 16:31 56 About tests wTest result ranges color coding m e t s y s e h t f o w e i v r e v O 2 The following types of measuring ranges can be distinguished:
System measuring range Institution-set measuring range The ranges define details of the glucose result screen
(such as the color coding and showing quantitative or qualitative result values) and can be used to trigger specific messages. For glucose test strips, the system measuring range is 10 to 600 mg/dL (0.6 to 33.3 mmol/L). The table contains examples of glucose test results in the different ranges. The numbering of the examples corresponds with the numbering in the color coding image above. Critically high result message. The message text can be configured via the DMS. The test result value is critically high
(HI). The test result value is critically high. The test result value is above the normal range but not yet critically high. The test result value is within the normal range. The test result value is below the normal range but not yet critically low. 1 2 3 4 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Reportable rangeReportable rangeCritically highCritically lowAbove normal rangeBelow normal rangeWithin normal range1234567Critically highConfirmHICritically high300mg/dLCritically high160Above normal rangemg/dL95Normal rangemg/dL60Below normal rangemg/dL Overview of the system 57 6 7 The test result value is critically low. The test result value is critically low
(LO). Critically low result message. The message text can be configured via the DMS. Your instrument can be configured to display a warning message for test result values which are within the following ranges:
Above the upper reportable range Critically high Critically low Below the lower reportable range Patient results history button displays the Local results dialog Tapping the box. It contains details of all test results for the patient being tested that are stored locally on the instrument:
Date and time Type of test (glucose, insulin) Result value Result range details Tapping the button displays Range details dialog box. It contains the high and low values configured by your healthcare facility for the following ranges:
Normal range Critical range Reportable range Comments button indicates that comments can be added to The the glucose test result. Comment entry optional Comment entry mandatory When comment entry is mandatory, you can only perform the next test step after at least 1 comment has been entered and saved. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 30Critically lowmg/dLLOCritically lowCritically lowConfirm 58 About tests button displays the Comments dialog Tapping the box in which you can enter up to 3 comments for the glucose test result as required. For glucose tests, the instrument can be configured so that a comment must be entered when a result is within one of the following categories:
Outside the normal range. Below the critical range lower limit, or above the critical range upper limit. Below the reportable range lower limit or above reportable range upper limit. To edit comments entered, tap the Comments dialog box is displayed in which you can edit the comments. button and the u About adding comments to a test result (62) If your instrument is configured to record the sample type used in the glucose test, the Sample type field is displayed on the test result screen. It contains the type of sample recorded. The Test strip lot number field contains the lot number of the test strip used in the glucose test. The first 6 digits of the lot number are displayed on the screen. All 8 digits of the lot number are shown on packaging and the test strip container. Other information About performing QC tests m e t s y s e h t f o w e i v r e v O 2 Accurately testing known levels of glucose ensures that the system and the technique used in testing provide accurate results on patient samples. QC lockout The system may be configured to require QC testing before patient testing is allowed. This is called QC lockout, and the system prevents patient and proficiency testing when the QC results are not within the accepted range. QC intervals The intervals between running QC tests are determined by your healthcare facility. These intervals are entered when the system is configured. At the end of the specified interval (or after a specific event such as Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 59 starting to test with a new test strip lot), a warning is displayed when the instrument is powered on and when the Glucose Test function is selected. QC tests should be run in the following circumstances:
Before using the instrument for patient testing the At the QC intervals established by your healthcare When using a new test strip container for the first first time. facility. time. When using a new test strip lot for the first time (and as a result a new test strip ID). If a test strip container was left open. If questionable test results occur repeatedly. If you wish to test the performance of the system. In addition, the following events can be specified during setup as a reason for a QC test:
If a previous QC test failed. If glucose QC tests were not run at the proper intervals. When a QC test is required, you will not be able to test blood glucose until the QC tests have been run successfully. For emergencies, override QC can be configured on the instrument. This allows the instrument to perform a limited number of blood glucose tests, if circumstances require, despite the instrument being in a QC lockout. When a QC lockout is activated due to a failed QC test result, it is not possible to override QC lockout. QC test result Lot number of the QC material User ID (if configured) Level of QC material (level 1 or level 2) Lot number of the test strips Time and date of test Comments (if applicable) m e t s y s e h t f o w e i v r e v O 2 Information stored during QC testing The following information is stored for every QC test using a QC material:
QC materials For blood glucose test strips, QC materials for glucose tests that have 2 QC levels:
Level 1 (L1): Low (low values in test results) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 60 About tests Level 2 (L2): High (high values in test results) Custom deviation It is possible to change the pre-defined default deviations for each QC level in accordance with applicable regulations. About proficiency testing The custom deviations (to be configured for level 1 and level 2 in mg/dL or mmol/L) define, in combination with the given target level of each QC level, the permitted result range to have a QC PASS result. u Related topics Performing a QC test (122) About the QC lockout (66) Lockout types (68) You perform proficiency tests on samples provided to you by an independent organization. Some regulatory agencies require that these proficiency samples be tested as part of an institution's quality assurance program before certification of the healthcare facility is allowed. Test result Sample ID Lot number of the test strips Time and date of test Comments (if applicable) User ID (if configured) Linearity tests help you check the function and accuracy of the entire system over the full range of specified values. Linearity samples should be treated in the same manner as the QC materials used in QC testing. Information stored during proficiency testing The following information is recorded for a proficiency test:
m e t s y s e h t f o w e i v r e v O 2 About linearity testing Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Linearity testing intervals The linearity of the system should be checked before it is used the first time for patient testing. Overview of the system 61 The term linearity describes the ability of the system to maintain a constant accuracy over the full range of specified values. If test results were plotted against expected values as a curve over the full range of these values, the ideal (high linearity) would be a straight line. Linearity is the range of values from the lowest to the highest for which the instrument is proven capable of giving accurate results. i The instrument does not perform a linear regression. Linearity testing can also be run when you want to check the overall performance of the system. The intervals for subsequent linearity tests are determined by the healthcare facility that operates the system. The instrument passes a linearity test when all 12 results
(each level is measured twice) were within the specified target range of each level. Test result Lot number of the linearity material Linearity level (level 1 to level 6) User ID (if configured) Lot number of the test strips Time and date of test Comments (if applicable) m e t s y s e h t f o w e i v r e v O 2 Linearity kit The linearity kit contains glucose solutions in 6 levels (6 bottles, 2.5 mL each). For additional information about the contents and handling of the kit, refer to the package insert. Information stored during linearity testing The following information is recorded for a linearity test:
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 62 About tests About the observed test sequence (OTS) The observed test sequence (OTS) enables an observer
(supervisor) to assess and record a users ability to perform a glucose patient test (for recertification purposes, for example). The observer monitors a user performing a test to check that the test is being performed according to recommended procedures. The supervisor then evaluates the performance and passes or fails the user. This assessment is saved together with the glucose test result and any necessary comments. If a users current certification expires, they are locked out from performing tests. The user can be notified by a personal message, in advance, that they must recertify. The notification is configured using the Show user lockout warning prior to user certificate expiration configuration item. Comments enable you to add supplemental information to a test result. button or a button in a test result screen A indicates that you can enter comments for that result. All test types can be configured for comments to be entered for a test result. The color of the comment button indicates that comment entry is optional or mandatory. When comment entry is mandatory, the next step in the test can only be performed after at least one comment has been entered. About adding comments to a test result m e t s y s e h t f o w e i v r e v O 2 Comment entry optional Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Glucose testResultWithin normal rangeConfirmGlucose95mg/dLNo comments Overview of the system 63 Comment entry mandatory button in the test To enter a comment you tap the result screen and the Comments dialog box is displayed. You can enter a maximum of 3 comments for a test result. The number of comments entered is indicated on the title bar of the Comments dialog box. A Title indicating the number of comments entered C Predefined comments B Custom comment (free text) D Toggle button to invalidate results (patient-related tests only) wComments dialog box Comment types Each test type has a set of predefined comments to select from. They are defined on the DMS. You select a comment by tapping it. You can enter 1 custom comment (free text) of up to 20 characters. The keyboard is displayed when you tap the text field. Editing comments After you have entered and saved comments, the button in the test result screen changes to the To edit comments entered, tap the Comments dialog box is displayed again in which you can edit the comments. button and the button. m e t s y s e h t f o w e i v r e v O 2 Patient-related test comments For glucose tests, emergency tests, and OTS the instrument can be configured so that a comment must be entered when a result is within one of the following categories:
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Comments (1/3)New test strip lotPhysician notifiedWill repeat testRN notifiedNo actionEnter a commentInvalid resultResult will be excluded from local results history.0/20CancelSaveCDBA 64 About tests Outside the normal range. Below the critical range lower limit, or above the critical range upper limit. Below the reportable range lower limit or above reportable range upper limit. Quality-related comments For QC tests and linearity tests, the instrument can be configured so that a comment must be entered when a test fails. Invalid result toggle button For patient-related tests (glucose tests, emergency tests, and OTS) the lower area of the Comments dialog box contains the Invalid result toggle button. The Invalid result toggle button is used to remove an
"invalid result" from the Patient results on the Local results screen. For example, when an error was made while performing a test (dirt on the hand). The result is still transmitted to DMS (flagged as invalid). u Related topics Performing a glucose test (116) Performing a QC test (122) The test strip port light indicates when you should take test strip-related actions. The table indicates the different colors used in the test strip port light and the corresponding statuses and required actions. The colors apply to both glucose tests and QC tests. Test strip port is not illuminated Instrument is turning on Error during self-checks Errors during measurement Test strip ejected White Ready for test strip insertion About the test strip port light m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 65 Test strip inserted and recognized Test strip checked and passed Ready for sample application Blue White Blue Sufficient sample has been applied and processing is underway Magenta Eject test strip m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 66 About lockouts About lockouts About the QC lockout In this section About the QC lockout(66) Lockout types(68) A QC lockout on an instrument occurs when a QC test is due. It is probably the most common type of lockout. You remove a QC lockout by performing QC tests. QC lockout is indicated on the charging screen and on the Glucose screen. On the Tests screen QC lockout is indicated on a test button by a symbol on its top right corner. You cannot make measurements on the instrument until the lockout has been removed. You remove a QC lockout by performing and passing a QC test. Depending on the QC lockout configuration, this can be at QC level 1 or 2, or level 1 and 2. i If your instrument is configured to allow you to override a QC lockout, you can perform a test despite a QC lockout, when the QC lockout was the result of a QC algorithm configuration condition. Your instrument can be configured to allow you to override a QC lockout up to 9 times before you must perform a QC test. However, if the QC lockout was the result of a failed QC test, the QC lockout cannot be overridden. A QC lockout is triggered by the following;
By fulfilling a QC algorithm configuration condition A failed QC test After certain software updates The QC algorithm is configured on the instrument through the DMS, or by using a QR code. The following configurations are possible:
QC disabled m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 67 Until failed QC Time interval Shift Test strip count Time of day With the exception of the QC disabled and Until failed QC configurations, a configured QC lockout can be alternating or non-alternating. i You can view your instruments QC configuration
> Instrument information >
by going to QC interval. Disabled QC lockout is disabled. Glucose tests can be performed at any time, regardless of the result of a possible QC test. Until failed QC A QC lockout is activated only when a QC test failed. With this configuration, a QC lockout also occurs the first time the instrument is used. In both cases, to remove the QC lockout, you must run and pass a QC test at QC level 1 and one at QC level 2. Time interval A QC lockout is activated after a specified number of hours. To remove the QC lockout, you must run and pass a QC test at QC level 1 and one at QC level 2. The hour counter is reset to 0. Shift A QC lockout is activated with each changeover of user work shifts. To remove the QC lockout, you must run and pass a QC test at QC level 1 and one at QC level 2. Time of day A QC lockout is activated at a specified time of day. Up to six times per day can be configured. To remove the QC lockout, you must run and pass a QC test at QC level 1 and one at QC level 2. Test strip count A QC lockout is activated after a pre-defined number of tests have been performed. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 68 About lockouts Only successful measurements are included in the test strip count. To remove the QC lockout, you must run and pass a QC test passed both QC test levels. New test strip lot You can configure the instrument to handle new test strip lots in one of the following ways:
Using a new test strip lots is possible without having a QC test passed for it. Using a new test strip lot is only possible after having a QC test passed for both QC levels. Alternating / non-alternating QC lockout To remove an alternating QC lockout, you perform a QC test where the required QC level alternates. If you remove the first QC lockout with a QC test passed for QC level 1, you remove the next one with a QC test for QC level 2, and so on. To remove a non-alternating QC lockout, you must perform QC tests with QC level 1 and 2 passed. Software update A software update (from Roche) can be configured to trigger a QC lockout. The QC lockout applies irrespective of any other QC lockout that was configured. To remove the lockout, you must run and pass a QC test at level 1 and one at level 2. This applies even if an alternating QC lockout is configured. u Related topics Lockout types (68) Lockout types m e t s y s e h t f o w e i v r e v O 2 A lockout stops you from performing specific actions on the instrument until you take the appropriate corrective action. There are different types of lockout:
Instrument synchronization QC Temperature Low battery Memory User certification Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 69 The lockout type determines the corrective action you should take. By tapping a button with a lockout badge a dialog box is displayed providing guidance. QC lockout A QC lockout is triggered by the following;
By fulfilling a QC algorithm configuration condition A failed QC test After certain software updates u About the QC lockout (66) Synchronization lockout A synchronization lockout occurs when the instrument has not synchronized with the DMS in a defined time period. The period of time between the last synchronization with the DMS and the synchronization lockout is calculated in terms of a warning of the lockout and the lockout itself. The lockout warning displays after a defined period of time since the last DMS synchronization. The time period is set using the Show synchronization lockout warning prior to actual lockout (in hours) configuration item. The synchronization lockout occurs after a defined period of time after the warning was displayed. The time period is set using the Synchronization lockout (in hours) configuration item. The following are unavailable due to the lockout;
Glucose test Proficiency test QC test Linearity test Insulin entry OTS Synchronization lockout can be overridden for a pre-
determined number of times. The Allow QC /
synchronization lockout overrides configuration item enables the override. The number of times the override can be used (9 maximum) is set using the Number of lockout overrides allowed configuration item, If the override is enabled, you can perform emergency tests and override lockouts for glucose tests. This is possible as long as the override lockout counter value has not been exceeded. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 70 About lockouts Synchronization lockout is resolved by synchronizing the instrument with the DMS. Additionally a user with administration rights can reset synchronization lockout by choosing Administrator > Reset synchronization lockout
Temperature lockout A temperature lockout occurs when the instrument temperature is too high or too low for the test strips to operate correctly. The following are unavailable due to the lockout;
Glucose test Emergency test OTS Proficiency test QC test Linearity test Override QC lockout Temperature lockout stops when the instrument temperature is within the acceptable operating temperature range. u Environmental conditions (87) Battery lockout A battery lockout occurs when the instrument battery level is too low for measurements to take place. The following are unavailable due to the lockout;
Glucose test Emergency test OTS QC test Linearity test Override QC lockout A battery lockout stops when the instrument battery has recharged sufficiently (15%). u Replacing the battery (177) Memory lockout A memory lockout occurs when the maximum memory of the instrument database is reached and no further test data can be stored. The following tests can be unavailable due to the lockout. Since the tests have different data storage requirements, only the test you select will be locked. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 71 Glucose test Emergency test OTS Proficiency test QC test Linearity test Insulin entry Memory lockout is resolved by synchronizing the instrument with the DMS to ensure it has sufficient free memory. User lockout User lockout occurs when a users certificate expires and they require recertification. The instrument can be configured to display a user certification expiration warning in advance of the individual user certification expiration. The lockout is displayed on the home screen when a user requiring certification is logged in. The warning and tab. lockout is shown on the Only the observed test sequence (OTS) is available in this lockout type. The lockout is resolved by the user taking and passing an OTS. As a result, the users name is added to an updated user list which is distributed to all instruments. This enables the user who was locked out to perform tests again. u User certification status (74) u Performing an observed test sequence (OTS) (145) m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 72 List of notifications List of notifications Notifications provide you with reminders and messages. You access the Notifications screen by tapping the button on the navigation bar. A new notification is indicated by a blue badge on the button
. You may receive the following notification types:
QC status Instrument cleaning status Instrument synchronization status Instrument memory status User certification status Message of the day Personal message The order in which the notification types appear on the Notifications screen (above) is fixed. When the next QC test is due (the date, or the number of tests remaining before hand). The date since the instrument has been in QC lockout
(shown in red). button to the right of the notification Tapping the message displays the QC test screen, from which you can run a QC test. A different lockout type may prevent you from performing a QC test. Tapping the button displays a dialog box for each of the lockout types preventing you. The QC lockout notification is determined by the QC algorithm configuration item. u QC algorithm (376) QC status The notification indicates either:
m e t s y s e h t f o w e i v r e v O 2 Instrument cleaning status This notification indicates that either:
Instrument cleaning is due (date/event). Cleaning can be logged. If a cleaning interval is configured, an icon and an indication of when the next cleaning is due are displayed. If only cleaning after a measurement is required, an instruction is displayed. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Instrument synchronization status This notification only shows when a synchronization warning or lockout have occurred. Overview of the system 73 When instrument cleaning is overdue, a red warning icon and the date and time of the instrument cleaning is displayed. The instrument cleaning notification is determined by the following configuration items:
Cleaning notification after each patient test Time interval for cleaning notification (in hours) u Cleaning notification after each patient test (480) u Time interval for cleaning notification (in hours) (480) A synchronization lockout occurs when the instrument has not synchronized with the DMS within a defined time period. It indicates:
The number of unsynchronized results The date and time of the synchronization lockout, either:
When the lockout is expected. When the lockout occurred (warning icon and time of lockout displayed in red) Synchronization lockout is resolved by synchronizing the instrument with the DMS. The instrument synchronization notification is determined by the following configuration items:
Show synchronization lockout warning prior to actual lockout (in hours) Synchronization lockout (in hours) u Show synchronization lockout warning prior to actual lockout (in hours) (390) u Synchronization lockout (in hours) (391) m e t s y s e h t f o w e i v r e v O 2 Instrument memory status This notification only shows when an instrument memory warning or lockout have occurred. It indicates that either:
The instrument will run out of memory soon A memory lockout has occurred (warning icon and displayed in red) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 74 List of notifications Instrument memory lockout is resolved by synchronizing the instrument with the DMS to ensure it has sufficient memory. User certification status This notification only shows when a there is a certification warning for the user currently logged on or their recertification is due. Message of the day This notification only shows if a message is configured for the instrument. It indicates either:
The date when the recertification is required. The recertification is overdue (warning icon and displayed in red) When the instrument is not configured to use user lists, or to show user certificate expiration, this notification never displays. It has the header "Message of the day", with the message below it. If the message is longer than one line, it is indicated by an ellipsis (...) at the end of the line. Tapping the notification opens a dialog box containing the message. The message of the day notification is determined by the Message of the day configuration item. u Message of the day (479) Personal message This notification is only shown for instruments using user lists, and when a personal message has been set for the user currently using the instrument. It has the header "Personal message", with the message below it. If the message is longer than one line, it is indicated by an ellipsis (...) at the end of the line. Tapping the notification opens a dialog box containing the message. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 75 Overview of the User Assistance About the User Assistance In this section About the User Assistance(75) Overview of User Assistance functions(76) Accessing the User Assistance online(78) Accessing the User Assistance offline(79) Searching in the User Assistance(80) The User Assistance supports you in your daily work. It is available in different formats (e.g., online, offline,...). The functionalities provided by the user interface are similar across all formats. The User Assistance window is divided into a main panel and a detail panel. m e t s y s e h t f o w e i v r e v O 2 A Tabs for selective information access (tabs available D Global information area depend on configuration) B Main panel C Panel splitter wOverview of the User Assistance window Tabs in the main panel E Buttons for navigation and other functions F Detail panel Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 ABCDEF 76 Overview of the User Assistance Home To view the description of the available tabs. From here, you can access each tab directly. Search in this publication To search for information in the whole User Assistance. Table of contents Recently viewed To get an overview of the User Assistance publication. To get a list of the most recent topics that you have viewed. Favorites To store your frequently used topics for direct access at any time. Overview of User Assistance functions Enlarging images You can enlarge an image by choosing the beside it. The image is displayed in a callout in which you can further zoom in using the zoom slider. button m e t s y s e h t f o w e i v r e v O 2 Browsing history You can use the backwards and forwards in your browsing history. navigation buttons to go and Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Overview of the system 77 Related topics At the end of some topics, there is a list of links to other topics that contain related information. You can go back to the original topic using the button. Viewing descriptions of terms button in text indicates that you can view The information about the term to the buttons left. When you choose the description of the term. button, a callout is displayed containing a Downloading a PDF You can download the publication to your computer in PDF format using the Download PDF button. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Related topicsDownload PDF 78 Overview of the User Assistance Giving feedback In the User Assistance online, at the bottom of each topic, you can give feedback on that topic. We use your feedback to improve the next update of our publications. Accessing the User Assistance online When accessing the User Assistance online, the latest content is always available. i If you have no internet access, contact your Roche representative for a standalone version of the User Assistance. d j m PC, tablet, or smartphone (iOS or Android) m Connection to internet m Internet browser (Safari or Chrome) m Access to the Roche DiaLog portal provided by your Roche representative r To use the User Assistance online 1 In the browser, enter the link to the Roche DiaLog portal (dialog.roche.com). 2 Choose the Log on button and enter your Roche DiaLog user name and password. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Send feedbackYesNoWas not the topic that I was looking forTopic was not clear/understandableEnter an email addressEnter your feedback hereCancelSend Overview of the system 79 3 In the list of e-services, find the User Assistance card, and then choose the Launch button in the card. f The User Assistance publication selector is displayed. 4 Use the filter settings to find the publication you want. 5 Select the publication that you want, and then choose the Add publication button, and then the Add to list button. 6 To access a User Assistance, choose the desired publication and then, on the detail panel, choose the Open publication button. You can use the standalone User Assistance offline on your PC. No internet connection is required. i To get the installer for the standalone User Assistance, contact your Roche representative. d m PC m Installer for standalone User Assistance r To access the User Assistance offline 1 Copy the installer for the standalone User Assistance to your PC. 2 Double-click the installer file, and then follow the instructions in the installation wizard. 3 Once installed, start the User Assistance, by double-
clicking the User Assistance icon on your desktop. m e t s y s e h t f o w e i v r e v O 2 Accessing the User Assistance offline Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 LaunchUser AssistanceAdd publicationsSystemLanguageComponentSoftware versionCancel 80 Overview of the User Assistance Searching in the User Assistance Search options There are 2 search options in the User Assistance:
Use the search function in the User Assistance to find information directly. Text search: Searches the text entered in the search field. Faceted search: Limits the number of search results using filters. You can combine both search options. A Text search function wSearch options B Faceted search function m e t s y s e h t f o w e i v r e v O 2 Search results The Search results table lists the 20topics with the highest ranking. The term you searched for is highlighted. If you searched for a deprecated term, the preferred term is highlighted. Topic types The icon on the left of the search results shows you the topic type:
Description Procedure Reference Explains concepts and gives additional background information. Explains how to perform a task step-by-step. Provides reference information. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 ABSearch in this publicationSearch resultsTypeTopicSearch in this publicationSearch resultsTypeTopic Overview of the system 81 r To perform a search in the User Assistance 1 In the User Assistance, choose the tab. 2 To perform a simple search, enter full or partial text entries, and then choose the button. 3 To perform a faceted search, choose the button. f The filter drop-down lists are displayed. 4 From the drop-down lists, choose one or more search filters. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Search in this publicationSearch resultsTypeTopicSearch in this publicationSearch resultsTypeTopic 82 Overview of the User Assistance Page intentionally left blank. m e t s y s e h t f o w e i v r e v O 2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 83 Specifications In this chapter General specifications.......................................................... Technical specifications ...................................................... Environmental conditions ................................................... Dimensions and weights..................................................... List of accessories and consumables............................. Barcode specifications......................................................... Radio equipment specifications ....................................... 3 85 86 87 88 89 90 93 s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 84 Table of contents Page intentionally left blank. s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Specifications 85 General specifications The instrument has the following basic characteristics:
Data storage System up to 100 proficiency test results up to 2000 patient result records up to 3 comments for each test record up to 500 glucose QC result records up to 50 linearity test results up to 300 test strip lot code containers up to 15000 user ID records up to 15000 patient records up to 200 OTE reagents records up to 50 QC lot records up to 10 linearity lot records up to 5000 entries audit trail records 480 x 800 pixel Wireless power transfer (WPT) Barcode camera RFID reader BluetoothLE WLAN IEEE 802.11 a/b/g/n/ac (single stream n) Screen resolution Interfaces Instrument Instrument Charging station Power supply Wireless power transfer (WPT) DC connector Replaceable AC input contacts y General specifications s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 86 Technical specifications Technical specifications The power supply must fulfill the following requirements. Never operate the system if one of the environmental conditions is not fulfilled. Instrument Charging station Power supply Instrument Charging station Power supply Instrument Instrument Input voltage Input current Battery voltage type Data transfer rate y Technical specifications Wireless charging
+ 12 V DC 100-240 V AC, 50-60 Hz Wireless charging 2.5 A (max) 0.6-0.3 A 3.6 volt rechargeable (lithium technology) WLAN IEEE 802.11 a/b/g/n/ac (single stream n):
up to 65 Mbps (2,4 GHz) up to 433 Mbps (5 GHz) s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Specifications 87 Environmental conditions The location must comply with the following conditions:
International (Europe) US / Canada Ambient temperature during operation Ambient temperature during long-term storage Ambient Temperature short term transport Ambient humidity during operation Ambient humidity during long-term storage Maximum operating height
(above sea level) y Environmental conditions Instrument Charging station Power supply Carry case Instrument Charging station Power supply Carry case Instrument Charging station Power supply Carry case Instrument Charging station Power supply Carry case Instrument Charging station Power supply Carry case Instrument Charging station Power supply 12-40 C 12-40 C 0-45 C 12-40 C 5-40 C 5-40 C
-40-70 C 5-40 C
-25-70 C
-25-70 C
-40-70 C
-25-70 C 54-104 F 54-104 F 32-113 F 54-104 F 41-104 F 41-104 F
-40-158 F 41-104 F
-13-158 F
-13-158 F
-40-158 F
-13-158 F 10-90% (non-condensing) 10-90% (non-condensing) 0-95% (non-condensing) 10-90% (non-condensing) 5-85% (non-condensing) 5-85% (non-condensing) 5-95% (non-condensing) 5-85% (non-condensing) 4,300 m 4,300 m 4,300 m 14,107 feet 14,107 feet 14,107 feet Sample temperature Instrument Refer to the package insert for information s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 88 Dimensions and weights Dimensions and weights The system components have the following dimensions and weights:
Instrument International (Europe) 390 g (inc. battery) y Dimensions and weight of the instrument Charging station International (Europe) Depth Width Height Weight Height Width Depth Weight Depth Width Height Weight Depth Height Width Weight 30 mm 77 mm 210 mm 140 mm 100 mm 95 mm 250 g 55 mm 90 mm 260 g 80 mm 250 mm 305 mm 1000 g y Dimensions and weight of the charging station Power supply International (Europe) 34 mm
(without AC plug) y Dimensions and weight of the power supply Carry case International (Europe) y Dimensions and weight of the carry case US 1.18 in 3.03 in 8.27 in 0.86 lb US 5.51 in 3.94 in 3.74 in 0.55 lb US 1.34 in 2.17 in 3.54 in 0.57 lb US 3.15 in 9.85 in 12 in 2.20 lb s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Specifications 89 List of accessories and consumables You should ensure that you use the correct accessories and consumables when performing tests and measurements. Product name cobas GLU test strips cobas GLU QC kit cobas GLU linearity kit y Consumables and reagents Product name cobaspulse cobaspulse carry case cobaspulse battery Description Test strips QC kit Linearity kit Description Instrument Carry case Battery cobaspulse charging station Charging station cobaspulse power supply Power supply POC Access Point Wi-Fi access point y Accessories and other components Catalog number 09009582 08275858 08275866 Catalog number 08990824 09009272 09314539 08726388 08689008 09187316 s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 90 Barcode specifications Barcode specifications Barcodes provide a means of entering data in the cobas pulse system (user ID/patient ID entry, instrument configuration). WARNING!
Risk of barcode read errors If a barcode is read incorrectly, it may lead to patient misidentification and inappropriate therapy decisions. r When creating patient or user barcodes, always adhere to the applicable international IEC/ISO standards for the respective barcode type. r Ensure that barcode size and print quality (as defined in ISO/IEC 15416 and 15415) are adequate. r Carry out a plausibility check on all data scanned into and displayed by the instrument. To reduce the probability of a barcode being misread, it is strongly recommended that you use the configuration options for patient and/or user ID validation as applicable to your specific workflow. These options are:
Check the ID against a list Check ID for length(1) 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. When scanning, ensure that the barcode is completely inside the camera frame. i EAN 13 barcodes, although widely used in retail, are less appropriate for patient/user barcodes. If used, they demand the very highest quality standards of barcode creation and reproduction. i The instrument can be configured to enable and disable the barcode types used for scanning patient IDs and user IDs. For questions regarding working with barcodes that are not covered in this publication and for best practice guidelines on creating and reading barcodes, contact your Roche representative. s n o i t a c i f i c e p S 3
(1) If no user/patient list can be used, you should set a minimum length for the respective ID, even if your healthcare facility uses IDs of varying length. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Specifications 91 The barcode samples shown here are for illustration purposes only. If printed out, they can be used to check the barcode camera. However, they are not meant to be used as a reference for size or resolution of real patient or user ID barcodes. When creating patient or user barcodes, always refer to the relevant standard ISO/IEC 15416 and 15415 for size and resolution requirements and to the specifications listed in the table. Recommended specification Comment Print resolution Reflective contrast Symbol grade 300 dpi preferred 200 dpi minimum 70% or greater Grade C or above Grade B is preferred Symbol grades are A-F based on analysis of several quality elements. Module width
(minimum) 0.16 mm (1D barcodes) 0.20 mm (2D barcodes) y Recommended specifications for barcode labels At 200 dpi issues with the wide-to-
narrow ratio may exist. Matte finish is preferred over glossfinish. Depending on quality grade parameters for a specific barcode, grade C may not be sufficient when motion, reflection, or poor lighting occur. i Ensure that your printer can print the module width of the barcode with the required resolution, that is, that there is no mismatch between print resolution and module width. Supported barcode types Codabar Code 39 Code 93 Code 128 EAN 13 GS1 DataBar Limited Interleaved 2 of 5 without checksum s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 92 Barcode specifications Interleaved 2 of 5 with checksum PDF417 Aztec DataMatrix QR code s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Specifications 93 Radio equipment specifications This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the FCC radio frequency (RF) Exposure Guidelines. This equipment is tested for specific absorption ratio
(SAR) and complies with FCC/IC radiation exposure limits set forth for an uncontrolled environment. This device complies with FCC/IC SAR limit of 1.6 W/kg. The device for operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systems. Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment. Instrument 2400 - 2472 MHz and 5180 -
5835 MHz Frequency (MHz) Maximum radio-frequency power (mW) Number of RFID readers Number of RFID antennas 63 1 1 y Radio equipment specifications s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 94 Radio equipment specifications Page intentionally left blank. s n o i t a c i f i c e p S 3 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Operation 4 5 Frequently performed tasks....................................................................... 97 Routine operation........................................................................................111 6 Non-routine operation...............................................................................129 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 97 Frequently performed tasks In this chapter Logging on to the Glucose app ....................................... Charging the instrument ..................................................... Checking notifications ......................................................... Putting the instrument into standby mode................... Waking the instrument from standby mode ................ Logging off the Glucose app ............................................. 4 99 104 105 107 108 109 s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 98 Table of contents Page intentionally left blank. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Frequently performed tasks 99 Logging on to the Glucose app If your instrument is switched off you must turn it on and log on in order to use it. After turning on your instrument, depending on your instruments configuration, there are 3 options:
1. You must always log on. 2. You need only log on to perform a QC test. 3. You do not need to log on. For options 1 and 2, depending on your instruments configuration, you log on using one of the following methods:
RFID tag Barcode scan Keyboard entry All options and logon methods are explained in this task. u To log on to the Glucose app using an RFID tag (99) u To log on to the Glucose app using a barcode (100) u To log on to the Glucose app using the keyboard
(102) u No logon required (103) m You have a valid user ID j r To log on to the Glucose app using an RFID tag 1 Remove the instrument from the charging station and do one of the following:
In the Glucose screen, tap the Log on button. If the app library is displayed, tap the Glucose app and then in the Glucose screen, tap the Log on button. f The User logon screen is displayed. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 GlucoseLog on 100 Logging on to the Glucose app 2 Swipe your RFID tag over the RFID icon on the rear of your instrument, as shown by the animation. f If a password is required the Enter password screen is displayed. f If a password is not required the Tests screen is displayed. Log on is complete. 3 In the Enter password screen, enter your password in the Password field and then tap the Log on button. f The Tests screen is displayed. Logon is complete. 4 When you have finished using the instrument, dock it in the charging station. f You are logged off automatically. r To log on to the Glucose app using a barcode 1 Remove the instrument from the charging station and do one of the following:
In the Glucose screen, tap the Log on button. If the app library is displayed, tap the Glucose app and then in the Glucose screen, tap the Log on button. f The User logon screen is displayed. 2 In the User logon screen, if the Scan user ID tab is not displayed, tap the f The barcode camera is activated, tab. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 User logonEnter passwordLog onGlucoseLog on Frequently performed tasks 101 3 CAUTION! Ensure that the barcode is flat and not damaged. Position the instrument so that the barcode is visible on the screen and inside the white frame. I If there is insufficient light, tap the turn on the built-in flashlight. button to f If a barcode is detected the frame turns green and the Enter password screen is displayed. Password entry is required. Go to the next step. f The frame turns green the Tests screen is displayed (if configured). Password entry is not required. Log on is complete. f The frame turns red and a message is displayed at the bottom of the screen. The barcode content may be invalid. f If no barcode is detected the frame remains white and the scan times out. The barcode may be degraded and requires checking. Use the keyboard entry if available. 4 In the Enter password screen, enter your password in the Password field and then tap the Log on button. f The Tests screen is displayed. Logon is complete. 5 When you have finished using the instrument, dock it in the charging station. f You are logged off automatically. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 User logonEnter passwordLog on 102 Logging on to the Glucose app r To log on to the Glucose app using the keyboard 1 Remove the instrument from the charging station and do one of the following:
In the Glucose screen, tap the Log on button. If the app library is displayed, tap the Glucose app and then in the Glucose screen, tap the Log on button. f The User logon screen is displayed. 2 In the User logon screen, tap the tab. 3 In the Enter user ID screen enter your user ID and then tap the Next button. I The user ID is case sensitive. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 GlucoseLog onUser logonEnter user IDNext Frequently performed tasks 103 4 In the Enter password screen, enter your password in the Password field and then tap the Log on button. f The Tests screen is displayed. Logon is complete. r No logon required 1 Remove the instrument from the charging station. 2 In the Glucose screen, tap the Proceed button f The Tests screen is displayed. 3 When you have finished using the instrument, dock it in the charging station. u Related topics Performing a glucose test (116) Performing a QC test (122) Reviewing patient test results (120) Reviewing QC test results (126) s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 User logonEnter passwordLog onGlucoseProceed 104 Charging the instrument Charging the instrument When not being used, the instrument should be placed in the charging station. This ensures that the instrument has sufficient charge to operate. When the instrument is in the charging station the charging screen is displayed. If the instrument is turned off when placed in the charging station, it will start up, after which the charging screen is displayed. i If the instrument is turned off and does not start up when placed in the charging station, the battery may have insufficient charge. u Starting up an instrument with low battery level (193) j m Charging station is connected to a power source r To charge the instrument 1 Place the instrument in the charging station. 2 Check that the charging screen is displayed. f If the charging screen is not displayed, check that the charging station is connected to a power source. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Frequently performed tasks 105 Checking notifications Notifications provide you with reminders and messages. Notifications are accessed by tapping the the navigation bar. A blue badge on the button indicates a new notification. button on After you have taken the appropriate action, the notification is removed from the Notifications screen. The action you take depends upon the type of notification. Depending on your instruments configuration, you can receive any of the following types of notification:
QC status Instrument cleaning status Instrument synchronization status Instrument memory status User certification status Message of the day Personal message c When there is a blue badge on the button. r To check notifications 1 On the navigation bar, tap the button. f The Notifications screen displays containing one or more notifications. 2 For a QC lockout notification, tap the button. I If one or more other lockouts are preventing you performing the QC test, tapping the displays dialog boxes informing you of the lockouts. button f The QC test screen is displayed in which you can perform a QC test. 3 For an Instrument cleaning due notification, after cleaning the instrument appropriately, do the following:
Tap the In the Instrument cleaning dialog box, tap the Confirm button to confirm that the instrument has been cleaned. button. 4 If a notification warns of, or indicates that there is a lockout due to unsynchronized results, synchronize your instrument the DMS to remove the lockout. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 NotificationsQC lockoutInstrument cleaning due21-Mar-2020, 10:1322-Mar-2020, 15:27 106 Checking notifications 5 If a notification warns of, or indicates that there is a lockout due to insufficient memory, synchronize your instrument the DMS to remove the lockout 6 For a notification of a message, do the following:
Tap the message to display the corresponding message screen. After reading the message, tap the return to the Notifications screen. button to s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Frequently performed tasks 107 Putting the instrument into standby mode When the instrument is not in the charging station and not in use, standby mode can be activated. In standby mode the instrument is inactive, and saving power as it is not processing or making measurements. Automatic activation of standby mode is set by the Standby timeout configuration item. If enabled it determines the length of time (seconds) an instrument must be inactive before standby mode is activated. The default value is 300 seconds (maximum 3,600 seconds). Otherwise the instrument can be put into standby mode using the on/off button. r To put the instrument into standby mode 1 Press the on/off button firmly. I The instrument vibrates. f The instrument goes into standby mode. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 108 Waking the instrument from standby mode Waking the instrument from standby mode When the instrument is not in the charging station and not in use, standby mode can be activated. In standby mode the instrument is inactive, and saving power as it is not processing or making measurements. The instrument can be configured to wake from standby mode using the Lift to wake configuration item. When enabled the instrument in standby mode is woken by movement detection. For example, by lifting the instrument. Otherwise the instrument can be woken from standby mode using the on/off button. r To wake the instrument from standby mode 1 Press the on/off button firmly. I The instrument vibrates. f The instrument wakes from standby mode. f Depending on the instruments configuration the Glucose screen or the app library is displayed. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Frequently performed tasks 109 Logging off the Glucose app When you have finished working in the Glucose app, you should log off. Depending on how your instrument is configured, after logging off from the Glucose app you are returned to the Glucose screen or to the app library. i An instrument can be configured to automatically activate standby mode after a pre-determined time period using the Standby timeout configuration item. r To log off the Glucose app 1 Do one of the following:
Place the instrument in the charging station. Press the on/off button. In the Tests screen, the Local results screen, or the Notifications screen, tap the f You are logged off the Glucose app. button. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 110 Logging off the Glucose app Page intentionally left blank. s k s a t d e m r o f r e p y l t n e u q e r F 4 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 111 Routine operation In this chapter Entering a patient................................................................... Performing a glucose test................................................... Reviewing patient test results ........................................... Performing a QC test ............................................................ Reviewing QC test results................................................... Adding comments to a test result ................................... 5 113 116 120 122 126 128 n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 112 Table of contents Page intentionally left blank. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Routine operation 113 Entering a patient The way in which you enter a patient depends on your instruments configuration. You enter a patient in the following tests:
Glucose test Insulin entry OTS The following configurations can be made to your instrument, and determine how you manage patient entry. Entry methods (barcode scan, keyboard entry) Autocomplete ID pattern recognition ID validation Patient confirmation u About patient entry (49) You enter a patient ID using one of the following methods:
RFID tag Barcode scan Keyboard entry j u To enter a patient using a barcode (113) u To enter a patient using the keyboard (114) m You are logged on to the instrument. m You have selected the appropriate test. m Patient ID confirmation dialog is enabled. m List-based (allow unknown patient IDs) is enabled. r To enter a patient using a barcode 1 In the test screen (e.g., Glucose test), if the barcode camera is not active, tap the tab. f The barcode camera is activated. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 114 Entering a patient 2 CAUTION! Ensure that the barcode is flat and not damaged. Position the instrument so that the barcode is visible on the screen and inside the white frame. I If there is insufficient light, tap the turn on the built-in flashlight. button to f If a barcode is detected the frame turns green and the Confirm patient dialog box is displayed. Go to the next step. f The frame turns red and a message is displayed at the bottom of the screen. The barcode content may be invalid, or the patient was not found. f If no barcode is detected the frame remains white and the scan times out. The barcode may be degraded and requires checking. Use the keyboard entry if available. 3 CAUTION! If the Confirm patient dialog box is displayed, ensure that the patient details are correct. Do one of the following:
If the patient details are correct, tap the Confirm button and continue with the test. If the patient details do not match the patient, tap the Cancel button and stop the patient entry. 4 If the scanned patient ID is not on the instruments patient list a dialog box is displayed. It asks you if you want to perform the test using this patient ID. Do one of the following:
Tap the Confirm button to perform the test using the scanned patient ID. Press the Cancel button to stop the patient entry. r To enter a patient using the keyboard 1 In the test screen (e.g., Glucose test), if keyboard entry is not active, tap the tab. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Confirm patientPatient IDGenderAgeDate of birthConfirmCancel Routine operation 115 2 In the Enter patient ID screen, enter the patient ID. I Patient ID entry is case sensitive. 3 Tap the Continue button. 4 If the Confirm patient dialog box is displayed, check that the patient details are correct, and then tap the Confirm button. f The next test screen is displayed. Continue with the test. 5 If the patient ID you entered is not on the instruments patient list a dialog box is displayed. It asks you if you want to perform the test using this patient ID. Do one of the following:
Tap the Confirm button to perform the test using the patient ID. Press the Cancel button to stop the patient entry. u Related topics Performing a glucose test (116) Entering insulin information (131) n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Enter patient IDContinueConfirm patientPatient IDGenderAgeDate of birthConfirmCancel 116 Performing a glucose test Performing a glucose test One of the main functions of the instrument is to perform glucose tests. The procedure outlined in this task contains the main steps that you perform when performing a glucose test. However, depending on your instruments configuration, there may be additional steps in the glucose test:
Patient ID confirmation (after entering the patient). Sample type selection (after entering the patient /
after Patient ID validation). Test strip ejection before confirming the test result
(not after). Comment entry (before result confirmation). Running another glucose test for the same patient
(after glucose test completion). Entering insulin information (after glucose test completion). i A colored test strip port light provides guidance of instrument status and actions you must take. In the case of a QC lockout, glucose testing cannot be performed until the lockout has been removed. Depending on how QC lockout is configured, you remove it by performing and passing a QC test at level 1, level 2, or level 1 and level 2. i If your instrument is configured to allow you to override a QC lockout, you can perform a test despite a QC lockout, when the QC lockout was the result of a QC algorithm configuration condition. Your instrument can be configured to allow you to override a QC lockout up to 9 times before you must perform a QC test. However, if the QC lockout was the result of a failed QC test, the QC lockout cannot be overridden. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Routine operation 117 WARNING!
Incorrect interpretation of test result when using anticoagulant tubes To avoid harmful outcomes resulting from the incorrect interpretation of a test result. r When using anticoagulant tubes, do not store the tube after drawing, but apply the blood immediately. u Entering a patient (113) u Performing a QC test (122) u About performing a glucose test (52) m Glucose test strips m Freshly obtained blood sample m New pair of disposable gloves m Waste container d j m You are logged on to the instrument m Specified QC tests have been completed successfully u Logging on to the Glucose app (99) r To perform a glucose test 1 In the Tests screen, tap the Glucose button. 2 Enter the patient ID using one of the following methods:
RFID tag Barcode scan Keyboard entry n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 TestsGlucose 118 Performing a glucose test 3 CAUTION! Close the test strip container immediately after removing the test strip. When prompted, insert a test strip by doing the following:
Remove the test strip from the test strip container and then close it. Insert the test strip into the test strip port as far as it will go. I The test strip port light color briefly turns blue
(test strip is recognized and checked), and then turns white (instrument is ready for sample application). An audible signal is emitted. f The instrument performs checks and notifies you of any issues. 4 CAUTION! Apply the blood sample promptly. Apply the blood sample to the front edge of the test strip, and not on the top of the test strip. Ensure that the test strip port is above or on the same level as the blood sample. I The time remaining in which to apply the blood sample is shown on the screen. You have 180 seconds. When sufficient sample has been applied, the test strip port light color turns blue and an audible signal is emitted. f The test is processed and the Result screen is displayed. 5 In the Result screen you can do the following:
button to view the test history for the Tap the patient being tested. Tap the dialog box.. Tap the if required. button to view the Range details button to add comments for the result 6 Tap the Confirm button f The Eject test strip dialog box is displayed. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Glucose testResultWithin normal rangeConfirmGlucose95mg/dLNo comments Routine operation 119 7 CAUTION! When you eject the test strip, ensure that you dispose of it in accordance with the applicable regulations. Never pull out the test strip. Hold the instrument vertically over the waste container. In the Eject test strip dialog box, touch and hold the button until the blue progress indicator has encircled the button. I The test strip port light color turns magenta. f The test strip is loosened and falls into the waste container. If it does not, gently shake the instrument to help test strip to fall out. u Related topics Entering insulin information (131) About the QC lockout (66) Adding comments to a test result (128) About collecting a blood sample (51) About the test strip port light (64) n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Eject test stripTouch and hold 120 Reviewing patient test results Reviewing patient test results You can review the patient test results that are stored on your instrument. The period of time for which a test remains on the instrument is configurable. You view the patient results on the Local results screen. Patient results for the following tests types are listed:
Glucose test Emergency test Insulin entry Test type Test result The result list provides a summary of each test result:
Date and time of the test result Patient name and ID Tapping a test result displays more information in the Result details screen. The information displayed depends upon the test type. You can locate a patient test result by scrolling through the list of results. Alternatively you can first search for the patient, and then locate the test result. j m Instrument is turned on. m You are logged on to the instrument. u Logging on to the Glucose app (99) r To review a patient test result 1 On the navigation bar, tap the button. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Routine operation 121 2 In Local results > Patient results tap the button. 3 To search for a patient whose result you require, do one of the following:
tab, search for the patient by using the In the keyboard and entering the patient ID or name. Tap the patient that you require. tab, and then scan the barcode of the 4 The search results for the patient are displayed in the Local results screen. The number of results found is indicated. 5 Tap a result to view more details. 6 In the Result details screen you can do the following:
View the details of the result. button to view the Range details Tap the dialog box. Tap the box. Tap the screen. button to view the Test details dialog button to return to the Local results n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Local resultsPatient resultsQC resultsJenny DoeUnknown patientJohn DoeJenny DoeGlucoseGlucoseGlucoseGlucoseRegular insulin99999999912345678901234567890123123123300991602 U22-Mar-2020, 16:3122-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2722-Mar-2020, 15:27mg/dLmg/dLmg/dLLocal resultsJenny DoeJenny DoeJenny DoeGlucoseGlucoseGlucoseGlucoseRegular insulin1234567890123456789012345678901234567890Jenny DoeGlucoseJenny Doe1234567890No. of results found: 152 U22-Mar-2020, 16:3122-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2721-Mar-2020, 10:1321-Mar-2020, 10:13320mg/dL333mg/dL315mg/dL370mg/dLResult detailsPatient IDDate of birthGenderNo commentsGlucoseTest strip lot numberJenny DoeWithin normal range95mg/dL 122 Performing a QC test Performing a QC test Accurately testing known levels of glucose ensures that the system and your technique used in testing give accurate results on patient samples. A QC test using QC material comprises the following:
Select the desired QC level for the test. Enter the QC material lot number. Perform the QC test with the QC material. For a QC test to be completed successfully, the result must fall within the specified range (as shown on the test strip container label or as defined by configuration). Patient tests can then be performed again. i If your instrument is configured to allow you to override a QC lockout, you can perform a test despite a QC lockout, when the QC lockout was the result of a QC algorithm configuration condition. Your instrument can be configured to allow you to override a QC lockout up to 9 times before you must perform a QC test. However, if the QC lockout was the result of a failed QC test, the QC lockout cannot be overridden. To remove a QC lockout, the levels flagged with
"Required" (see step 2) must be measured and have a
"PASS" result. QC materials for glucose tests have 2 QC levels:
Level 1 (L1): Low (low values in test results). Level 2 (L2): High (high values in test results). The procedure outlined in this task contains the main steps in a QC test. However, depending on your instruments configuration, there may be some differences:
Test strip ejection after confirming the test result (not before). Comment entry is mandatory (not optional). The procedures for performing Level 1 and Level 2 tests are the same. i Colored test strip port light provides guidance of instrument statuses / actions you must take. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Routine operation 123 c Intervals between running QC tests are determined by your healthcare facility. d j m Glucose QC material m Glucose test strips m Waste container m New pair of disposable gloves m The instrument is turned on. m You are logged on to the instrument. u Logging on to the Glucose app (99) r To perform a QC test 1 On the Tests screen, tap the QC button. 2 On the QC test screen, do one of the following:
To perform a level 1 QC test, tap the Level 1
(low) button. To perform a level 2 test, tap the Level 2 (high) button. I When a QC test is required (due to a QC lockout), the levels that you must test are indicated by
"Required". 3 To select the QC lot that you are using, do one of the following:
In the Scan QC level 1 barcode screen / Scan tab and QC level 2 barcode screen, tap the then scan the QC lot number barcode. On the Choose QC lot screen. tap the tab, and then tap the lot number that you are using. I The tab might be deactivated in your healthcare facility. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 TestsQCQC testLevel 1 (low)Level 2 (high)RequiredRequired 124 Performing a QC test 4 CAUTION! Close the test strip container immediately after removing the test strip. When prompted, insert a test strip by doing the following:
Remove the test strip from the test strip container and then close it. Insert the test strip into the test strip port as far as it will go. I The test strip port light color briefly turns blue
(test strip is recognized and checked), and then turns white (instrument is ready for sample application). An audible signal is emitted. f The instrument performs checks and notifies you of any issues. the test strip. 5 CAUTION! Do not apply the QC material to the top of When prompted, apply the QC material to the front edge of the test strip. Ensure that the test strip port is above or on the same level as the QC material. I The time remaining in which to apply the QC material is shown at the bottom of the screen. When sufficient QC material has been applied, the test strip port light color turns blue. An audible signal is emitted. f The QC test is processed after which the Eject test strip dialog box is displayed. 6 CAUTION! When you eject the test strip, ensure that you dispose of it in accordance with the applicable regulations. Never pull out the test strip. Hold the instrument vertically over the waste container. In the Eject test strip dialog box, touch and hold the button until the blue progress indicator has encircled the button. I The test strip port light color turns magenta. f The test strip is loosened and falls into the waste container. If it does not, gently shake the instrument to help test strip to fall out. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Eject test stripTouch and hold Routine operation 125 7 In the test result screen (Result - Level 1 / Result -
Level 2), you can do the following:
button to view the Range details button to add comments for the result Tap the dialog box. Tap the as required. 8 Tap the Confirm button. u Related topics Adding comments to a test result (128) About the test strip port light (64) n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 QC testGlucoseResult - Level 1PassedConfirm55mg/dLNo comments 126 Reviewing QC test results Reviewing QC test results You can review the QC test results that were performed on your instrument. The period of time for which a test result remains on an instrument is configurable. You view the QC results on the Local results screen. Results for the following tests types are listed:
QC test Linearity test Proficiency test QC level Test result The result list provides a summary of each test result:
Date and time of the QC test Tapping a test result displays more information in the Result details screen. The information displayed depends upon the test type. j m Instrument is turned on. m You are logged on to the instrument. u Logging on to the Glucose app (99) r To review a QC test result 1 On the navigation bar, tap the button. 2 In the Local results screen, tap the QC results tab. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Local resultsPatient resultsQC resultsJenny DoeUnknown patientJohn DoeJenny DoeGlucoseGlucoseGlucoseGlucoseRegular insulin99999999912345678901234567890123123123300991602 U22-Mar-2020, 16:3122-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2722-Mar-2020, 15:27mg/dLmg/dLmg/dL Routine operation 127 3 In the QC results tab, tap the result that you want to view. 4 In the Result details screen you can do the following:
View the details of the QC result. button to view the Range details Tap the dialog box. Tap the Tap the button to view further test information. button to return to the QC results tab. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Local resultsQC level 1QC level 2QC level 1Proficiency testLinearity testPatient resultsQC resultsGlucoseGlucoseGlucoseGlucoseGlucoseGlucosePassedFailedPassedFAIL225333244592725922-Mar-2020, 16:3122-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2721-Mar-2020, 10:1321-Mar-2020, 10:13mg/dLmg/dLmg/dLmg/dLResult detailsQC level 1GlucosePassedNo commentsQC lot numberTest strip lot number999999995678905922-Mar-2020, 16:31mg/dL 128 Adding comments to a test result Adding comments to a test result Comments enable you to add supplemental information to a test result. button or a button in a test result screen A indicates that you can enter comments for that result. All test types can be configured for comments to be entered for a test result. The color of the comment button indicates that comment entry is optional or mandatory. When comment entry is mandatory, the next step in the test can only be performed after at least one comment has been entered. Comment entry optional Comment entry mandatory u About adding comments to a test result (62) j m You are performing a test, and are in the result screen. m A button or a button is available. r To add comments to a test result 1 In the test result screen do one of the following:
Tap the Tap the button. button. 2 In the Comments dialog box, select up to 3 options and then tap the Save button. I A free-text comment has a maximum of 20 characters. f The Comments dialog box closes. 3 To edit the comments, do the following:
To display the Comments dialog box, tap the button. Edit the comments. Tap the Save button f The Comments dialog box closes. n o i t a r e p o e n i t u o R 5 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Comments (1/3)New test strip lotPhysician notifiedWill repeat testRN notifiedNo actionEnter a commentInvalid resultResult will be excluded from local results history.0/20CancelSave Table of contents 129 Non-routine operation In this chapter Entering insulin information............................................... Performing a linearity test................................................... Performing an emergency glucose test......................... Performing a proficiency test ............................................ Performing an observed test sequence (OTS)............ Adjusting the screen brightness and the volume level ............................................................................................. Reviewing the audit trail...................................................... Changing your user password .......................................... Turning on the instrument.................................................. Turning off the instrument.................................................. Restarting the instrument ................................................... Setting up the charging station ........................................ Lot management .................................................................... About test strip lot distribution.............................. Adding a test strip lot to the instrument ............ Reviewing test strip lot details on the instrument...................................................................... Deleting a test strip lot from the instrument .... Adding a QC or linearity lot to the instrument. Reviewing QC lots on the instrument.................. Deleting a QC lot from the instrument ............... 6 131 135 139 142 145 147 148 150 151 152 153 154 155 155 156 158 159 160 161 162 n o i t a r e p o e n i t u o r
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n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Non-routine operation 131 Entering insulin information You can record information about insulin administered to a patient. Your instrument can be configured to enter insulin information in 2 ways:
On the Tests screen by tapping the Insulin button. After performing a Glucose test. You enter insulin information on 5 pages, between which you can move using Next and Previous buttons. You record the following information:
Date and time of the insulin administration Patient details Insulin type Insulin name Comments about the insulin administration j m Your instrument is turned on and you have logged on. m Your instrument is configured to enter insulin information r To enter insulin information 1 Do one of the following:
On the Tests screen, tap the Insulin button. At the end of a glucose test, in the Options dialog box, tap the Enter insulin dose button, and then go to step 4. 2 In the Insulin entry screen do one of the following:
Scan the patient details barcode. tab, enter the patient name or the Tap the patient ID, and then tap the Continue button. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 TestsInsulin 132 Entering insulin information 3 In the Confirm patient dialog box, tap the Confirm button if the patient details are correct. 4 In the Date/time screen, the date and time default to the current date and time. To enter different values, do the following:
To change the date, tap the Date field and use the date picker to set a date, and then tap the Confirm button. To change the time, tap the Time field and use the time picker to set a time, and then tap the Confirm button. To move to the next screen, choose the Next button. 5 In the Insulin type screen, tap the appropriate insulin type, and then tap the Next button. I To change a value in a previous screen, tap the Previous button to go to the screen. After making the change, tap the Next button to return to the current screen. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Confirm patientPatient IDGenderAgeDate of birthConfirmCancelDate/timeDateTimePreviousNextInsulin typeRapid-acting insulinPreviousNextRegular insulinIntermediate-acting insulinLong-acting insulinInsulin mixtures Non-routine operation 133 6 In the Insulin name screen, tap the appropriate name, and then tap the Next button. 7 In the Insulin units screen do the following:
Using the number pad, tap the appropriate number. Tap the Tap the Next button. button. 8 In the Comments screen, select up to 3 comments and then tap the Next button. I You can add a free-text comment of up to 20 characters. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Insulin nameHumulin RPreviousNextNovolin RInsulin unitsEnter unitsPreviousNextCommentsPreviousNextPhysician notifiedRN notifiedNo actionProcedure errorEnter a comment 134 Entering insulin information 9 In the Insulin entries screen, tap the Confirm button to complete the insulin information entry. I To change an entry, tap the corresponding button, make the amendment, and then tap the Confirm button. Changing certain entries (e.g. insulin type) may require associated entries to be changed. u Related topics Performing a glucose test (116) Entering a patient (113) n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Insulin entriesConfirmTimeCommentsInsulin nameInsulin typeDateInsulin units Non-routine operation 135 Performing a linearity test Linearity tests help you check the function and accuracy of the entire system over the full range of specified values. A linearity test comprises the following main steps:
Checking the lot number of the linearity material. Checking the lot number of the test strips. Perform the test with a minimum of 3 linearity levels. i When performing a linearity test, the instrument does not perform a linear regression. c Determined by your healthcare facility. d j m Linearity kit m Glucose test strips m New pair of disposable gloves m Waste container m The instrument is turned on. m You have logged on to the instrument. r To perform a linearity test 1 In the Tests screen, tap the Linearity button. 2 In the Linearity test screen do one of the following:
Scan the linearity kit lot barcode. If enabled, tap the Choose linearity kit lot, tap the lot you will use to perform the test. tab and then below n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 TestsLinearity 136 Performing a linearity test 3 In the Linearity test screen tap the Level 1 button. 4 CAUTION! Close the test strip container immediately after removing the test strip. When prompted, insert a test strip by doing the following:
Remove the test strip from the test strip container and then close it. Insert the test strip into the test strip port as far as it will go. I The test strip port light color briefly turns blue
(test strip is recognized and checked), and then turns white (instrument is ready for sample application). An audible signal is emitted. f The instrument performs checks and notifies you of any issues. test strip. 5 CAUTION! Do not apply the material to the top of the When prompted, apply the material to the front edge of the test strip. Ensure that the test strip port is above or on the same level as the material. I The time remaining in which to apply the material is shown at the bottom of the screen. You have 180 seconds. When sufficient material has been applied, the test strip port light color turns blue. An audible signal is emitted. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Linearity testLevel 1Level 2Level 3Level 4Level 5Level 6RequiredRequiredRequiredRequiredRequiredRequired Non-routine operation 137 6 CAUTION! When you eject the test strip, ensure that you dispose of it in accordance with the applicable regulations. Never pull out the test strip. Hold the instrument vertically over the waste container. In the Eject test strip dialog box, touch and hold the button until the blue progress indicator has encircled the button. I The test strip port light color turns magenta. f The test strip is loosened and falls into the waste container. If it does not, gently shake the instrument to help test strip to fall out. 7 In the Result - Level 1 for run 1 screen you can view the result and then tap the Proceed button. f The Insert test strip screen for the second run is displayed. 8 To perform the second run for the level 1 test, repeat steps 4 to 7. f The result of the second run is displayed. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Eject test stripTouch and holdLinearity testRun 1 of 2Result - Level 1GlucosePassedLinearity kit lot numberTest strip lot number23.4mg/dLProceed 138 Performing a linearity test 9 Tap the Proceed button. f The Linearity test screen is displayed, indicating if level 1 has passed or failed. 10 To test the remaining 5 levels, do the following:
Tap the next required level button (for example, the Level 2 button). Perform runs 1 and 2 for leach remaining level by repeating steps 4 to 9. 11 After performing run 2 of level 6, you are prompted to eject the test strip. f The Linearity test > Result screen is displayed. 12 You can do the following:
button to view the results of all runs Tap the for all levels in the Result details dialog box. Tap the button to add comments to the result. 13 Tap the Confirm button to close the Linearity test screen and return to the Tests screen. I You can view the test result at any time in Local results > QC results. u Related topics Reviewing QC test results (126) n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Linearity testLevel 1Level 2Level 3Level 4Level 5Level 6PassedRequiredRequiredRequiredRequiredRequiredLinearity testGlucoseResultAll levels passedConfirmNo commentsPASSLinearity kit lot numberTest strip lot number Performing an emergency glucose test Non-routine operation 139 You perform an emergency glucose test when you need to perform a glucose test but a patient ID is not available. Consequently, you skip patient identification and start testing directly to get the result as fast as possible. When your instrument is configured to perform an emergency glucose test, the Emergency button is available on the Tests screen. With the exception of patient ID confirmation your instruments regular glucose test configuration applies to an emergency glucose test. i If your instrument is configured to override a QC lockout, you can perform an emergency test despite a QC lockout, when the QC lockout was the result of a QC algorithm configuration condition. Your instrument can be configured to allow you to override a QC lockout up to 9 times before you must perform a QC test. However, if the QC lockout is the result of a failed QC test, the QC lockout cannot be overridden. WARNING!
Incorrect interpretation of test result when using anticoagulant tubes To avoid harmful outcomes resulting from the incorrect interpretation of a test result. r When using anticoagulant tubes, do not store the tube after drawing, but apply the blood immediately. u About performing a glucose test (52) m Glucose test strips m Freshly obtained blood sample m New pair of disposable gloves m Waste container d j m You are logged on to the instrument. m Your instrument is configured to perform emergency glucose tests. u Logging on to the Glucose app (99) n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 140 Performing an emergency glucose test r To perform an emergency glucose test 1 In the Tests screen, tap the Emergency button. 2 CAUTION! Close the test strip container immediately after removing the test strip. When prompted, insert a test strip by doing the following:
Remove the test strip from the test strip container and then close it. Insert the test strip into the test strip port as far as it will go. I The test strip port light color briefly turns blue
(test strip is recognized and checked), and then turns white (instrument is ready for sample application). An audible signal is emitted. f The instrument performs checks and notifies you of any issues. 3 CAUTION! Apply the blood sample promptly. Apply the blood sample to the front edge of the test strip, and not on the top of the test strip. Ensure that the test strip port is above or on the same level as the blood sample. I The time remaining in which to apply the blood sample is shown on the screen. You have 180 seconds. When sufficient sample has been applied, the test strip port light color turns blue and an audible signal is emitted. f The test is processed and the Result screen is displayed. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 TestsEmergency Non-routine operation 141 4 Before confirming the result, you can do any of the following:
Tap the Tap the if required. button to view the result range details. button to add comments for the result 5 Tap the Confirm button. f The Eject test strip dialog box is displayed. 6 CAUTION! When you eject the test strip, ensure that you dispose of it in accordance with the applicable regulations. Never pull out the test strip. Hold the instrument vertically over the waste container. In the Eject test strip dialog box, touch and hold the button until the blue progress indicator has encircled the button. I The test strip port light color turns magenta. f The test strip is loosened and falls into the waste container. If it does not, gently shake the instrument to help test strip to fall out. u Related topics Entering insulin information (131) Adding comments to a test result (128) About collecting a blood sample (51) About the test strip port light (64) n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Emergency glucose testResultWithin normal rangeConfirmGlucoseUnknown patient95mg/dLEject test stripTouch and hold 142 Performing a proficiency test Performing a proficiency test You perform blood glucose proficiency tests on samples provided by an independent organization and whose values are unknown to you. The results should be forwarded to the appropriate source after completing the test. The supplied samples are treated in the same manner as regular patient samples. The procedure outlined in this task contains the main steps that you perform in a proficiency test. i A colored test strip port light provides guidance of instrument status and the actions you must take. In the case of a QC lockout, proficiency testing cannot be performed until the lockout has been removed. Depending on how QC lockout is configured, you remove it by performing and passing a QC test at level 1 and/or level 2.. d j m Proficiency material m Glucose test strips m New pair of disposable gloves m Waste container m You are logged on to the instrument. m Instrument is not in QC lockout. u Logging on to the Glucose app (99) u Performing a QC test (122) n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Non-routine operation 143 r To perform a proficiency test 1 In the Tests screen, tap the Proficiency button. 2 In the Proficiency test screen, do one of the following Scan the sample ID barcode. Tap the tap the Continue button. tab, enter the sample ID, and then 3 CAUTION! Close the test strip container immediately after removing the test strip. When prompted, insert a test strip by doing the following:
Remove the test strip from the test strip container and then close it. Insert the test strip into the test strip port as far as it will go. I The test strip port light color briefly turns blue
(test strip is recognized and checked), and then turns white (instrument is ready for sample application). An audible signal is emitted. f The instrument performs checks and notifies you of any issues. test strip. 4 CAUTION! Do not apply the material to the top of the When prompted, apply the material to the front edge of the test strip. Ensure that the test strip port is above or on the same level as the material. I The time remaining in which to apply the material is shown at the bottom of the screen. You have 180 seconds. When sufficient material has been applied, the test strip port light color turns blue. An audible signal is emitted. 5 Depending on your instruments configuration do the following:
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n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 TestsProficiency 144 Performing a proficiency test If the Result screen is displayed, continue with step 6. If the Eject test strip button dialog box is displayed, perform step 8, and then steps 6 and 7. 6 In the Result screen you can do the following:
button to view the Range details Tap the dialog box. Tap the if required. button to add comments for the result 7 Tap the Confirm button. I You can view the test result at any time in Local results > QC results. 8 CAUTION! When you eject the test strip, ensure that you dispose of it in accordance with the applicable regulations. Never pull out the test strip. Hold the instrument vertically over the waste container. In the Eject test strip dialog box, touch and hold the button until the blue progress indicator has encircled the button. I The test strip port light color turns magenta. f The test strip is loosened and falls into the waste container. If it does not, gently shake the instrument to help test strip to fall out. u Related topics Reviewing QC test results (126) n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Proficiency testGlucoseResultConfirm34No commentsmg/dLEject test stripTouch and hold Non-routine operation 145 Performing an observed test sequence
(OTS) The observed test sequence (OTS) enables an observer
(supervisor) to assess and record a users performance
(for certification purposes, for example). The observer watches the user performs a glucose test, after which they assess the user in terms of the:
Glucose test result Observed test sequence Since the test involves the user and the observer, an indication of who performs each step is provided. u Performing a glucose test (116) c When recertification is required r To perform an observed test sequence 1 USER:
2 OBSERVER:
Log onto the Glucose app, and on the Tests screen, tap the button. In the Observer logon screen, log on as the observer using one of the following:
RFID tag Barcode scan Keyboard entry 3 USER:
In the Observed glucose test screen do the following:
Perform a glucose test. In the Result screen, tap the Proceed button. 4 OBSERVER:
In the Observer logon screen, enter your password and tap the Log on button. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 146 Performing an observed test sequence (OTS) 5 OBSERVER:
In the Assessment screen, tap the Glucose test result option. 6 OBSERVER:
In the Glucose test result screen tap the appropriate option (Valid or Invalid.). 7 OBSERVER:
In the Assessment screen, tap the Observed test sequence option. 8 OBSERVER:
9 OBSERVER:
10 OBSERVER:
11 OBSERVER:
In the Observed test sequence screen tap the appropriate option (Passed or Failed). In the Assessment screen, tap the button. In the Comments dialog box, enter an appropriate comment (20 characters maximum), and then tap the Save button. In the Assessment screen do the following:
Review the assessment. If necessary, amend the assessment by tapping the appropriate option and make the change. Tap the Confirm button. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 AssessmentGlucose test resultObserved test sequenceAdd a comment (required)ConfirmGlucose test resultValidInvalidObserved test sequencePassedFailed Non-routine operation 147 Adjusting the screen brightness and the volume level You adjust the instrument brightness and volume to suit your working environment. r To adjust the screen brightness and the volume level 1 Tap
> Brightness and volume. 2 To adjust the screen brightness do one of the following:
To increase the screen brightness, move the Brightness slider to the right. To decrease the screen brightness, move the Brightness slider to the left. 3 To adjust the volume level do one of the following:
To increase the volume level, move the Volume slider to the right. To decrease the volume level, move the Volume slider to the left. I When you stop moving the slider, the instrument emits an audible signal, indicating the volume level for that setting. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 BrightnessVolumeBrightness and volume 148 Reviewing the audit trail Reviewing the audit trail You use the audit trail to review the events that have taken place on an instrument. Each audit trail event has an entry on the Audit trail screen in terms of a title (for example, Material expired) and the date and time at which the event took place. Behind each event is an Audit trail details screen which provides more information about the event (for example, Use material from a valid lot to continue). The audit trail can help you troubleshoot problems that occur on the instrument and indicate any remedial action that you should take. u List of audit trail events (192) c As required r To review the audit trail 1 Tap
> Audit trail. 2 In the Audit trail screen, view the audit trail entries. I Scroll up and down the list to view more entries. 3 In the Audit trail screen, locate and tap the event that you want to view. f The corresponding Audit trail details screen is displayed. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Audit trailSettings changedUser logonInstrument cleaning performedWi-Fi association problemG-AA22-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2721-Mar-2020, 10:1321-Mar-2020, 10:13Instrument error Non-routine operation 149 4 In the Audit trail details screen, view the details of the event or error. 5 To return to the Audit trail screen. tap the button, n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Audit trail detailsUser logonDate and timeEvent22-Mar-2020, 15:27User logged on. 150 Changing your user password Changing your user password User passwords guard against unauthorized access to the Glucose app on instruments. Periodically you may be required to change your password. When choosing a new password, follow your healthcare facilitys guidelines on password management. The new password will be required the next time you log on to the Glucose app. It might not be available on all instruments immediately after you have made the change. If you do not have a password when logging on to the Glucose app for the first time, you are prompted to create one using the Change password dialog box. u Strong password management (22) c As required. r To change your user password 1 Choose
> Change password. 2 In the Change password dialog box do the following:
In the New password field, enter the new password. In the Confirm new password field, enter the new password again. I An error message notifies you when the passwords you enter do not match. 3 Choose the Save button. 4 In the Password changed dialog box, tap the Confirm button. f Your password is changed. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Change passwordNew passwordConfirm new passwordCancelSave Non-routine operation 151 Turning on the instrument You can turn on the instrument in one of two ways:
Using the on/off button. Placing the instrument in the charging station. j m Instrument battery has sufficient charge r To turn on the instrument 1 Do one of the following:
Press and hold the on/off button for approximately 3 seconds. Place the instrument in the charging station. I In each case an audible beep is made. f The cobas splash screen displays and then, depending on the instruments configuration, the Glucose screen or the app library is displayed. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 152 Turning off the instrument Turning off the instrument You should only turn off the instrument when it will not be used for a considerable period of time. i An instrument will not communicate with the DMS when it is turned off. Normally the instrument should be placed in the charging station when it is not being used. Ensure that you store the instrument correctly until it is next used. j m The instrument will not be operated for a considerable length of time r To turn off the instrument 1 Press and hold the on/off button until the Power off / Restart menu is displayed. I The instrument emits regular beeps while you do 2 Tap the Power off option. f The splash screen displays and the instrument this. turns off. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Non-routine operation 153 Restarting the instrument You should only restart the instrument when instructed to. For example, by an error message. r To restart the instrument 1 Press and hold the on/off button until the Power off / Restart menu is displayed. I The instrument emits regular beeps while you do this. restarts. 2 Tap the Restart option. f The splash screen displays and the instrument f The splash screen displays again. Depending on the instruments configuration the Glucose app screen or the app library is displayed. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 154 Setting up the charging station Setting up the charging station The charging station must be connected to a power source. When setting up the charging station, ensure that it is placed where it is easily accessible and within sufficient distance of a power outlet. i the charging station should not be located in direct sunlight, or where it might be easily knocked over, causing the instrument to fall out. u Overview of the charging station (39) r To set up the charging station 1 Remove the rear panel by gently pushing it downwards, and then slide it out from the charging station. 2 Plug the power supply into the socket in the back of the charging station. 3 Put the rear panel back in place. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot management About test strip lot distribution Digital lot data reception with manual release Non-routine operation 155 In this section About test strip lot distribution(155) Adding a test strip lot to the instrument(156) Reviewing test strip lot details on the instrument(158) Deleting a test strip lot from the instrument(159) Adding a QC or linearity lot to the instrument(160) Reviewing QC lots on the instrument(161) Deleting a QC lot from the instrument(162) Test strip lot distribution enables test strips from new test strip lots to be used for performing tests. There are 3 methods by which new test strip lots are distributed within a healthcare facility:
Digital lot data reception with manual release Manual lot data retrieval with manual release Manual lot data retrieval with automatic release Digital lot distribution requires a connection to cobas infinity edge. Manual lot distribution does not involve cobas infinity edge. Each distribution method is outlined in the following sections. 1 2 3 4 5 6 7 A new test strip lot is released and sent to the healthcare facility. A corresponding lot data file is created and sent to cobas infinity edge. The Point of Care coordinator uses the instrument to scan a new test strip lot barcode on a test strip container. The lot data file is downloaded from cobas infinity edge to the Point of Care coordinators instrument. The Point of Care coordinator validates the lot. The Point of Care coordinator activates the lot (in the DMS). The lot data file is distributed from the DMS to the healthcare facility instruments. y Digital lot data reception with manual release workflow n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 156 Lot management Manual lot data retrieval with manual release 8 9 1 2 3 4 5 6 7 8 1 2 3 4 5 6 A nurse uses a test strip from the new lot. If configured, the nurse is first prompted to perform a QC test. The test strips from the new lot can be used. y Digital lot data reception with manual release workflow A new test strip lot is released and sent to the healthcare facility. A corresponding lot data file is created and sent to cobas infinity edge. The lot data file appears as a QR code in the cobas infinity edge portal. The Point of Care coordinator uses their instrument to scan the QR code. The lot data file is uploaded from the Point of Care coordinators instrument to the DMS. The Point of Care coordinator validates the lot if required. The Point of Care coordinator activates the lot (in the DMS). A nurse uses a test strip from the new lot. If configured, the nurse is first prompted to perform a QC test. The test strips from the new lot can be used. y Manual lot data retrieval with manual release workflow A new test strip lot is released and sent to the healthcare facility. A corresponding lot data file is created and sent to cobas infinity edge. The lot data file appears as a QR code in the cobas infinity edge portal. The Point of Care coordinator uses their instrument to scan the QR code. The lot data file is uploaded from the Point of Care coordinators instrument to the DMS. A nurse uses a test strip from the new lot. If configured, the nurse is first prompted to perform a QC test. The test strips from the new lot can be used. y Manual lot data retrieval with automatic release workflow You must add a new test strip lot to your instrument in order to be able to use the test strips from that lot. The distribution of test strips from a new lot will depend on the best practice of your healthcare facility. Manual lot data retrieval with automatic release n o i t a r e p o e n i t u o r
n o N 6 Adding a test strip lot to the instrument Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Non-routine operation 157 The instrument can be configured to perform a QC test the first time a test strip from a new lot is inserted into the instrument. CAUTION!
Instrument is not connected to cobas infinity edge If the instrument is not connected to cobas infinity edge you cannot add a test strip lot as described in this task. r You must scan the QR code generated in the cobas infinity edge portal using the Configuration by barcode option. The new strip lot is then added to the Lot management screen.
c As required d j m Test strip container and test strips from the new lot m The new lot has been uploaded to the DMS m Connection to cobas infinity edge r To add a test strip lot to the instrument 1 In the Glucose app, tap
> Lot management. 2 In the Lot management screen on the Test strip lots tab, tap the Add test strip lot button. 3 Using the Scan bottle barcode screen, scan the barcode of the new test strip lot container. f A message confirms that the new lot has been added. The new lot is added to the Test strip lots tab. 4 Do one of the following:
If you are not prompted to perform a QC test, you can start using the test strips from the new lot. If prompted, perform a QC test using the new test strip lot. After performing the QC test successfully you can start using the test strips from the new lot. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot managementQC lotsTest strip lotsLot No.TypeExpiry dateAdd test strip lotGLUGLUGLUGLUGLU 158 Lot management Reviewing test strip lot details on the instrument You can review the test strip lots on the instrument, as well as the details of an individual lot. The following information is available when reviewing an individual test strip lot:
Lot No. Expiry date Content version Type c As required r To review test strip lot details on the instrument 1 In the Glucose app, tap
> Lot management. 2 In the Lot management screen on the Test strip lots tab, you can do the following:
Review the test strip lots on the instrument. Tap a lot to view its details. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot managementQC lotsTest strip lotsLot No.TypeExpiry dateAdd test strip lotGLUGLUGLUGLUGLU Non-routine operation 159 3 In the Test strip lot details screen view the information about the lot. Deleting a test strip lot from the instrument You can delete a test strip lot from the instrument when it is no longer needed. Test strip lots are normally deleted from the instruments using the DMS. However, if this is not possible (for example, there is no DMS), test strip lots can be deleted using the instrument c As required r To delete a test strip lot from the instrument 1 In the Glucose app, tap
> Lot management. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Test strip lot detailsLot No.Expiry dateContent versionTypeGlucoseDelete 160 Lot management 2 In the Lot management screen in the Test strip lots tab, tap the lot you want to delete. 3 In the Test strip lot details screen, tap the Delete button. 4 In the Lot deletion dialog box, tap the Confirm button. f The lot is deleted from the instrument. n o i t a r e p o e n i t u o r
n o N 6 Adding a QC or linearity lot to the instrument You must add a QC or linearity lot to your instrument in order to be able to use a QC or linearity kit from the lot. The distribution of a new QC or linearity kit will depend on the best practice of your healthcare facility. c As required j m New QC or linearity lot bottle Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot managementQC lotsTest strip lotsLot No.TypeExpiry dateAdd test strip lotGLUGLUGLUGLUGLUTest strip lot detailsLot No.Expiry dateContent versionTypeGlucoseDelete Non-routine operation 161 r To add a QC lot to the instrument 1 In the Glucose app, tap
> Lot management. 2 In the Lot management screen, tap the QC lots tab. 3 On the QC lots tab, tap the Add QC lot button. 4 Using the Scan bottle barcode screen, scan the barcode on a bottle from the new lot. f If you are adding a new linearity lot, the new lot is added to the QC lots tab and a confirmation message is displayed. f If you are adding a new QC lot, the Set lot as
\'current\' dialog box is displayed. 5 To add the new QC lot, do one of the following:
To add the new QC lot and set it as the current lot, tap the Confirm button. To add the new QC lot but not set it as the current lot, tap the Cancel button. f The new QC lot is added to the QC lots tab. You can review the QC and linearity lots on the instrument, as well as the details of an individual lot. The following information is available when reviewing an individual QC lot:
Lot No. Expiry date QC version Type Default target range Hospital-defined target range Current lot The following information is available when reviewing an individual linearity lot:
Lot No. Expiry date Linearity version Type c As required n o i t a r e p o e n i t u o r
n o N 6 Reviewing QC lots on the instrument Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot managementTest strip lotsQC lotsLot No.TypeExpiry dateGLUGLUGLUGLUQC level 1QC level 2LinearityQC level 1Add QC lot 162 Lot management r To review QC lots on the instrument 1 In the Glucose app, tap
> Lot management. 2 In the Lot management screen, tap the QC lots tab. 3 In the QC lots tab you can do the following;
Review the QC and linearity lots on the instrument. Tap a lot to view its details. 4 In the QC lot details screen view the information about the lot. n o i t a r e p o e n i t u o r
n o N 6 Deleting a QC lot from the instrument You can delete a QC or linearity lot from the instrument when it is no longer needed. QC or linearity lots are normally deleted from instruments using the DMS. However, if this is not possible (for example, there is no DMS), they can be deleted using the instrument. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot managementTest strip lotsQC lotsLot No.TypeExpiry dateGLUGLUGLUGLUQC level 1QC level 2LinearityQC level 1Add QC lotQC lot detailsLot No.Expiry dateQC versionTypeGlucose, QC level 1Default target rangeHospital-defined target rangeCurrent lotDelete47 - 7153 - 65mg/dLmg/dL0 Non-routine operation 163 c As required r To delete a QC lot from the instrument 1 In the Glucose app, tap
> Lot management. 2 In the Lot management screen, tap the QC lots tab. 3 In the QC lots tab, tap the lot that you want to delete. 4 In the QC lot details screen, tap the Delete button. 5 In the Lot deletion dialog box, tap the Confirm button. f The lot is deleted from the instrument. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Lot managementTest strip lotsQC lotsLot No.TypeExpiry dateGLUGLUGLUGLUQC level 1QC level 2LinearityQC level 1Add QC lotQC lot detailsLot No.Expiry dateQC versionTypeGlucose, QC level 1Default target rangeHospital-defined target rangeCurrent lotDelete47 - 7153 - 65mg/dLmg/dL0 164 Lot management Page intentionally left blank. n o i t a r e p o e n i t u o r
n o N 6 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 7 Maintenance .................................................................................................167 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 167 Maintenance In this chapter About cleaning and disinfecting the instrument ....... Acceptable cleaning solutions and disinfectants ...... Cleaning and disinfecting the instrument .................... Cleaning and disinfecting the charging station ......... Cleaning and disinfecting the carry case ..................... Replacing the battery ........................................................... 7 169 171 172 175 176 177 e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 168 Table of contents Page intentionally left blank. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 169 About cleaning and disinfecting the instrument Ensure that you are fully familiar with the requirements for cleaning and disinfecting the instrument. Healthcare professionals should wear gloves and follow their facilitys infection control procedures when handling blood glucose testing equipment. The gloves worn during cleaning and disinfecting should be removed and hands washed thoroughly with soap and water before performing the next test. Dispose of acceptable cleaning solutions and disinfectants per facility guidelines. NOTICE!
Solutions used to clean and disinfect the instrument Using cleaning solutions and disinfectants containing ether, polyhexanide, or prepared solutions or using wipes containing a mixture of bleach and detergent can damage system components. r Only use cleaning solutions and disinfectants recommended by Roche. If a cleaning interval is configured, an icon and an indication of when the next cleaning is due are displayed. If only cleaning after a measurement is required, an instruction is displayed. When instrument cleaning is overdue, a red warning icon and the date and time of the instrument cleaning is displayed. The instrument cleaning notification is determined by the following configuration items:
Cleaning notification after each patient test Time interval for cleaning notification (in hours) u Cleaning notification after each patient test (480) u Time interval for cleaning notification (in hours) (480) e c n a n e t n a M 7 i Instrument cleaning status This notification indicates that either:
Instrument cleaning is due (date/event). Cleaning can be logged. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 170 About cleaning and disinfecting the instrument u Related topics Cleaning and disinfecting the instrument (172) Acceptable cleaning solutions and disinfectants
(171) e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 171 Acceptable cleaning solutions and disinfectants Cleaning solutions 0.5% liquid soap diluted in water Alcohol (70% ethanol or isopropyl alcohol) Disinfectants Having up to 70% alcohol (e.g., Bacillol AF) Only use recommended cleaning solutions and disinfectants to clean and disinfect the instrument. Before using a cleaning solutions and disinfectants on instrument components, refer to the product labelling for required contact time for cleaning solutions and disinfectants, and to ensure that the active ingredients are acceptable for use. Prepare all solutions per the manufacturers product labelling. Sodium hypochlorite up to 0.55% (e.g., CLOROX germicidal wipes) Quaternary ammonium compounds up to 0.5% (single compound or mixture) in isopropyl alcohol up to 55%
(e.g.,Super-Sani-Cloth) CAUTION!
Disinfecting the instrument with Clorox Damage to internal electronic components r When disinfecting the instrument using Clorox, do not allow any disinfectant to enter the instrument through the test strip port. u Related topics About cleaning and disinfecting the instrument (169) Cleaning and disinfecting the instrument (172) e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 172 Cleaning and disinfecting the instrument Cleaning and disinfecting the instrument Cleaning and disinfecting the instrument ensures that it will function correctly and efficiently. Your instrument can be configured to notify you to clean it as follows:
After each test. After a specified number of hours since the last time the instrument was cleaned. Clean the instrument to remove visible soil and organic material for safe handling and/or prior to disinfection. Disinfect the instrument when it is soiled as per your healthcare facilitys guidelines. Always ensure that the instrument is thoroughly dried after cleaning or disinfection. WARNING!
Incorrect test results Moisture in the test strip port may lead to incorrect test results. r Do not clean or disinfect the instrument while performing a test. r Do not get any moisture in the test strip port. r Do not spray into the test strip port. r Do not immerse the instrument in liquid. If liquid gets into the test strip port, immediately dry the components with a dry lint-free cloth or gauze. If solution is allowed to collect in any instrument opening, severe damage to the instrument can occur. Always ensure that the instrument is thoroughly dried after cleaning and disinfecting. c As specified by your healthcare facility. As configured on your instrument. d m Disposable gloves m Soft, lint-free cloth or gauze m Premoistened wipes for cleaning and disinfection m Cleaning solutions as per the manufacturers product labelling. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 173 u Acceptable cleaning solutions and disinfectants
(171) r To clean and disinfect the instrument 1 Remove the instrument from the charging station. 2 Turn off the instrument and then place it on a level surface. 3 Gently wipe the surfaces (touch screen, instrument housing) with the cloth slightly dampened (not wet). For each surface, apply 3 horizontal and 3 vertical passes. Use an unused part of the towelette for each pass. I If using commercially available premoistened wipes for cleaning and disinfection, before wiping the surface of the instrument, squeeze off excess solution or blot on a dry paper towel to remove any excess solution. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 174 Cleaning and disinfecting the instrument 4 CAUTION! Wear gloves if spraying the instrument. It may get slippery when wet so take care not to drop it. Do not spray the instrument if it is docked in the charging station!
Carefully wipe over the test strip port area, making sure that no liquid enters the test strip port. 5 Dry the instrument thoroughly with a the lint free cloth or gauze after cleaning. Visually verify that no solution is seen anywhere on the instrument after cleaning. 6 If you notice streaks on the instrument housing or touch screen, or the touch screen surface becomes slightly cloudy, wipe clean immediately with a soft, lint-free cloth slightly dampened with water. 7 After cleaning and disinfecting, if required, tap the button and in the Notifications screen, tap the button. 8 In the Instrument cleaning dialog box, tap the Confirm button confirming that the device has been cleaned and disinfected as per defined procedure. u Related topics About cleaning and disinfecting the instrument (169) e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 175 Cleaning and disinfecting the charging station Cleaning and disinfecting the charging station ensures that it will function correctly and efficiently. Clean the charging station to remove visible soil, and disinfect it as per your healthcare facilitys guidelines. c As specified by your healthcare facility. d m Disposable gloves m Soft, lint-free cloth or gauze m Pre-moistened wipes for cleaning and disinfection m Cleaning solutions as per the manufacturers product labelling
(171) station u Acceptable cleaning solutions and disinfectants r To clean and disinfect the charging 1 Unplug the charging station. 2 CAUTION! Do not allow any solution to enter the underside of the charging station. Wipe over the surfaces with a soft lint-free cloth slightly dampened. 3 CAUTION! Ensure that no solution is visible on or in the charging station after disinfecting. Dry the charging station thoroughly after cleaning/
disinfection. 4 Plug in the charging station. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 176 Cleaning and disinfecting the carry case Cleaning and disinfecting the carry case Cleaning and disinfecting the carry case thoroughly ensures that nothing can be transmitted to its contents. After cleaning and disinfecting the carry case, ensure that it has dried thoroughly before using it again. c As specified by your healthcare facility. d j m Disposable gloves m Soft, lint-free cloth or gauze m Pre-moistened wipes for cleaning and disinfection m Cleaning solutions as per the manufacturers product labelling
(171) m The carry case is completely empty u Acceptable cleaning solutions and disinfectants r To clean and disinfect the carry case 1 Wipe the carry case surface with a soft cloth slightly dampened (not wet). I If spraying the carry case, place it on a flat surface or table. 2 CAUTION! Do not place the instrument in the carry case until all cleaning/disinfecting steps are completed. Allow the carry case to air dry for the recommended contact time according to the cleaning/disinfecting solution product labeling. 3 Dry the carry case thoroughly with a dry cloth or gauze. Visually verify that no solution is in the carry case after cleaning/disinfecting. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 177 Replacing the battery When the battery no longer functions correctly it should be replaced. When shipped, the battery is installed in the instrument. Unused batteries lose their charge over time and must be recharged before they can be used. After installing a new battery, the instrument should be charged for at least 8 hours (e.g., overnight) in the charging station before testing. Replace the battery within approximately 10 minutes to retain the date and time settings. Beyond this period of time, and depending on the instruments configuration:
You must re-enter date and time. The date and time is set automatically by the DMS. NOTICE!
Disposal of used batteries r Do not dispose of the batteries with normal domestic waste. r Dispose of used batteries in accordance with applicable local regulations and directives and your healthcare facilitys guidelines on the disposal of electronic waste equipment. r As a component of the cobaspulse system, the battery must be deemed as potentially biohazardous. Treat it accordingly. c As necessary
< 10 minutes n d j m New battery (only official replacement battery supplied Roche) m Temperature range of 3-42 C or 37-108 F m Instrument is turned off. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 178 Replacing the battery r To replace the battery 1 Place the instrument face down on a level surface, and using a Torx screwdriver (T5), remove the two screws holding the battery compartment cover in place. 2 Remove the battery compartment cover from the instrument. The battery is now visible and connected to the instrument by a plug. 3 Using the plastic handle on the battery, carefully lift the battery out of the compartment. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Maintenance 179 4 Take the new battery and place it in the compartment. Ensure that the battery connector plug sits securely in its socket. Using a thumb or forefinger, gently apply downward pressure on the connector plug to ensure it is completely in the socket. 5 Close the battery compartment with the cover and tighten the 2 screws. 6 Place the instrument in the charging station to ensure that the battery is charging. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 180 Replacing the battery Page intentionally left blank. e c n a n e t n a M 7 i Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Troubleshooting 8 9 Troubleshooting ...........................................................................................183 Error messages.............................................................................................195 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 183 Troubleshooting In this chapter Resetting the instrument..................................................... Running a network status test .......................................... Network status test steps ................................................... Resetting a synchronization lockout............................... Deleting instrument data .................................................... List of audit trail events ....................................................... Starting up an instrument with low battery level ....... 8 185 186 188 190 191 192 193 g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 184 Table of contents Page intentionally left blank. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Resetting the instrument Troubleshooting 185 An instrument reset should only be performed when all other remedial actions have failed. For example, you might reset an instrument if it hangs. r To reset the instrument 1 Place the instrument on a level surface. 2 Press the on/off button for at least 10 seconds and then release the button. f The instrument turns off and on again. f The splash screen is displayed. f Depending on the instruments configuration, the Glucose app screen or the app library is displayed. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 186 Running a network status test Running a network status test You can use the Network status test option to help diagnose connectivity issues. The network status is given in terms of the following information:
Wi-Fi activated Associated Authenticated Received IP:
Gateway:
DNS:
Contacted DMS Connected to DMS Contacted cobas infinity edge Connected to cobas infinity edge Each network status item is tested. The status of each item in the network status check is indicated either of the following symbols:
Passed Failed When any of the Received IP:, Gateway:, and DNS:
items pass, the corresponding connection values are also displayed. u Network status test steps (188) r To run a network status test 1 Tap
> Instrument information > Network status test. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Troubleshooting 187 2 In the Network status test screen, tap the Test button. f The test result is displayed. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Network status testTestWi-Fi activatedAssociatedAuthenticatedReceived IP:Gateway:DNS:Contacted DMSConnected to DMSContacted cobas infinity edge10.0.0.10010.0.0.110.0.0.1 188 Network status test steps Network status test steps You use the Network status test option to help diagnose connectivity issues. You run the test by tapping information > Network status test.
> Instrument The test result screen contains each of the test steps and indicates if the step passes or fails. The table contains each of the test steps, and indicates the following:
Expected outcome (pass) The potential cause of a test step failing How to resolve a test step failure. Test step Expected outcome Potential cause of failure Solution Wi-Fi activated Instrument SW attempts to activate the Wi-Fi hardware Wi-Fi hardware defective Associated Wireless network out of reach Move the instrument to a WLAN hardware initiates connection to wireless access point Wireless access point/network applies the MAC address filtering Authenticated Instrument authenticates itself to the network Wrong credentials Restart the instrument and try again. If the problem persists, contact your Roche representative. location where the wireless network has sufficient signal strength. Add the MAC address (given on the instrument package) to the white list of permitted wireless clients within the network. Check if the assigned authentication/encryption type and/or the respective password/ pass phrase match the network settings. Dynamic IP address assigned to the instrument by a DHCP server, or static IP address assigned by the DMS or cobas infinity edge (QR code) DHCP server down/not available Check that DHCP server is correctly set up and running Typographic error (in case of static IP address) Wrong subnet mask configured (in case of static IP address) Double-check entered IP address in DMS / cobas infinity edge Enter correct subnet mask Received IP:
g n i t o o h s e b u o r T 8 l y Network status test steps Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Network status testTestWi-Fi activatedAssociatedAuthenticatedReceived IP:Gateway:DNS:Contacted DMSConnected to DMSContacted cobas infinity edge10.0.0.10010.0.0.110.0.0.1 Troubleshooting 189 Test step Expected outcome Potential cause of failure Solution Gateway:
IP address of a gateway DNS:
IP address of a Domain Name Service for IP/ host name resolution Contacted DMS Instrument tries to establish communication with DMS DMS server has more than one network card Enter correct DMS IP address /
host name Wrong Gateway configured (in case of static IP address) Enter correct gateway address Wrong DNS server configured
(in case of static IP address) Enter correct DNS server address Wrong gateway IP address (in case of static IP address) Enter correct gateway address Wrong DNS server IP address
(in case of static IP address) Enter correct DNS server address DMS is disconnected, busy, or down Check that the DMS is correctly set up and running Any type of network
(performance) issues Connected to DMS Instrument has successfully initiated a connection to the DMS application Connection has been disturbed in an early phase Contacted cobas infinity edge Instrument tries to establish communication with cobas infinity edge cobas infinity edge gateway server has more than one network card Enter correct cobas infinity edge gateway IP address /
host name cobas infinity edge gateway is disconnected, busy, or down Any type of network
(performance) issues Check all network components between the instrument and the DMS (cables, gateway, hub/ switch/router, firewall, proxy server etc.) Verify that the DMS supports the type and version of the instrument used Check that the cobas infinity edge gateway is correctly set up and running Check all network components between the instrument and the cobas infinity edge gateway (cables, gateway, hub/ switch/router, firewall, proxy server etc.) Verify that the cobas infinity edge gateway supports the software version of the instrument Connected to cobas infinity edge Instrument has successfully initiated connection to cobas infinity edge gateway Connection has been disturbed in an early phase y Network status test steps u Running a network status test (186) g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 190 Resetting a synchronization lockout Resetting a synchronization lockout You can use the reset synchronization lockout when a synchronization lockout has occurred on the instrument, and a synchronization lockout override is unavailable. This situation might occur due to a network failure, or other situations. The reset lasts for the period of time defined by the Synchronization lockout (in hours) configuration item, after which the synchronization lockout applies again. j m Administrator rights, if configured r To reset a synchronization lockout 1 Tap
> Administrator > Reset synchronization lockout. I If configured, enter the setup password to access the Administrator submenu. f A message is displayed saying Synchronization lockout was reset. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Troubleshooting 191 Deleting instrument data This option deletes all data on the instrument, and effectively returns it to a default configuration status. This includes uninstalling all third party apps. This might be necessary when there was a problem with the instrument configuration. It may be necessary to remove the instrument data to comply with data protection and privacy policies when returning the instrument to the manufacturer, or passing it on to another healthcare facility. This process is irreversible, so caution should be taken when using it. For example, if applicable, ensure that all data has been synchronized before deleting the instrument data. j m Administrator rights, if configured r To delete instrument data
> Administrator > Delete instrument 1 Tap data. f The Delete instrument data dialog box is displayed, explaining the implications of confirming. 2 In the Delete instrument data dialog box, tap the Confirm button. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 192 List of audit trail events List of audit trail events Audit trail events enables you to view the activity that has taken place on the instrument. The table contains all of the events that can be recorded in the audit trail. ID Severity Audit trail details (GUI) User password was changed. Item name: <item name>, previous value: <previous value>, new value: <new value>. Depends on individual level 1 message (C, W, N)
<level 1 message information> e.g., U-AB: Invalid Password
<level 2 error code> e.g., CA-0022 UPM SEP ERR CBS RFA RFD MTN SLU DMA DMB DMC PAT QCT USA USB RSA RSB RSC QCL LIN QCC STP SHA SWU STS LOQ LOS W N N N N W N N N N N N N N N N N N N N N N N N W C g n i t o o h s e b u o r T 8 l u Level 1 messages (213) u Level 2 errors (229) Start up performed. Wi-Fi association or authentication failed. Wi-Fi connection failed. Instrument cleaning was performed. Synchronization lockout was manually unlocked. DMS synchronization was completed. DMS synchronization was aborted by the instrument. DMS synchronization has failed. Patient test performed: Analyte: <analyte>, test strip lot: <strip lot number>. QC test performed: Analyte: <analyte>, test strip lot: <strip lot number>, kit: <kit>, level:<level>. User logged on. User logged off. cobas infinity edge synchronization completed. cobas infinity edge synchronization aborted by instrument. cobas infinity edge synchronization failed. QC lot was added. Analyte: <analyte>, lot no.: <lot number>. Linearity lot was added. Analyte: <analyte>, lot no.:<lot number>. QC or linearity version was added: <kit_type>, <version>. Test strip lot was added. Analyte: <analyte>, lot no.:<lot number>. Instrument turned off. Software update was performed. Software configuration: <SW_configuration>. Self-check was passed. QC lockout occurred. Synchronization lockout occurred. y Audit trail events u Reviewing the audit trail (148) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0
1 2 3 | User manual Part 2 | Users Manual | 3.12 MiB | December 17 2021 |
Troubleshooting 193 Starting up an instrument with low battery level A turned-off instrument with low battery level (<15%) will not start up automatically when placed in the charging station. However, an instrument with sufficient battery level (>15%) starts up automatically. In order for an instrument to start up and to operate, its battery must have sufficient charge (>15%). When it does not, the battery must be allowed to charge to a sufficient level so that the instrument can start up. i When left in the charging station until it has charged sufficiently, the instrument will not start up automatically. You must turn it on. r To start up an instrument with low battery level 1 Place the instrument in the charging station and do one of the following:
If the instrument starts up normally, no further action is required. If the instrument buzzes, the screen turns white, and a short battery animation is displayed, the instrument has insufficient battery charge to start up. Leave the instrument in the charging station to charge. 2 After allowing the instrument battery to charge, leave the instrument in the charging station, and then press the on/off switch. f If the instrument has sufficient battery charge, it starts up. f If the instrument displays a white battery icon it still has insufficient battery charge to start up. Allow further charging time and then repeat this step. u Related topics Charging the instrument (104) g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 194 Starting up an instrument with low battery level Page intentionally left blank. g n i t o o h s e b u o r T 8 l Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 195 Error messages In this chapter About level 1 messages and level 2 errors................... Level 1 messages................................................................... B-AA: Invalid barcode............................................... B-AB: Scan timeout.................................................... B-AC: Wrong sequence............................................ B-AD: Configuration error ....................................... C-AA: Database full ................................................... C-AB: Database error................................................ C-AD: Connection error ........................................... D-AA: Test strip error................................................ D-AB: Lot expired ....................................................... D-AE: Material expired ............................................. D-AF: Test strip error................................................. D-AG: Insertion error................................................. D-AH: Unknown lot.................................................... D-AJ: QC test required ............................................. D-AK: Insertion error ................................................. D-AL: Test strip error................................................. D-AN: Unknown kit lot ............................................. D-AO: Test strip error................................................ D-AP: Wrong lot .......................................................... E-AA: Temperature too low..................................... E-AB: Temperature too high................................... G-AA: Instrument error............................................. G-AC: Process error................................................... G-AE: Instrument error ............................................. H-AC: Low battery...................................................... H-AF: Date/time lost.................................................. H-AG: Ejection error .................................................. H-AJ: Battery version error...................................... 9 209 213 214 214 215 215 215 215 216 216 216 216 217 217 217 217 218 218 218 218 219 219 219 219 220 220 220 220 221 221 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 196 Table of contents I-AC: Software update error.................................... I-AE: Encryption error................................................ I-AF: Software update error .................................... I-AG: Synchronization failed ................................... I-AH: Connection error ............................................. I-AJ: Encryption warning.......................................... S-AB: Sample application error............................. S-AD: Sample type error .......................................... S-AF: Sample error..................................................... T-AA: Invalid RFID tag .............................................. T-AB: RFID timeout .................................................... U-AA: Invalid user ID................................................. U-AB: Invalid password............................................ U-AC: Patient not found........................................... U-AD: Invalid observer.............................................. U-AE: Invalid patient ID............................................ U-AF: User not found ................................................ U-AG: Unexpected bottle......................................... U-AJ: User not found ................................................ U-AK: Patient not found........................................... U-AL: Password too short........................................ U-AM: Passwords do not match........................... U-AN: Inconsistent insulin value .......................... U-AO: Invalid sample ID........................................... U-AP: Invalid sample ID ........................................... U-AQ: Insufficient user rights ................................ Level 2 errors ........................................................................... CA ..................................................................................... CA-0001: Unknown error.............................. CA-0002: Database access error ............... CA-0003: Database access error ............... CA-0004: Measuring unit communication error ...................................... CA-0005: Measuring unit communication error ...................................... CA-0006: Access to internal storage failed ..................................................................... CA-0007: Software error ............................... CA-0008: Test strip lot information not found .................................................................... CA-0009: Test strip lot expired ................... 221 222 222 222 222 223 223 223 223 224 224 224 224 225 225 225 225 226 226 226 226 227 227 227 227 228 229 229 232 233 233 233 234 234 234 235 235 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 197 CA-0010: Communication with measuring unit interrupted .......................... CA-0011: Software error ............................... CA-0012: Synchronization with DMS failed ..................................................................... CA-0013: Test strip inserted too early...... CA-0014: Test strip ID not recognized..... CA-0015: Error during Glucose app startup .................................................................. CA-0016: Barcode with invalid ID scanned ............................................................... CA-0017: QC lot expired ............................... CA-0019: User ID not found ........................ CA-0020: Patient ID not found.................... CA-0021: RFID tag invalid ............................ CA-0022: Invalid password .......................... CA-0023: Invalid patient ID.......................... CA-0024: Password too short...................... CA-0025: Passwords do not match........... CA-0026: Invalid insulin units ..................... CA-0027: Invalid insulin units ..................... CA-0028: Invalid user ID ............................... CA-0029: User ID not found ........................ CA-0030: Scan timeout.................................. CA-0031: RFID timeout.................................. CA-0032: Incorrect sample applied in a QC test or linearity test .................................. CA-0033: Incorrect sample applied in a glucose test........................................................ CA-0034: Wrong barcode sequence ........ CA-0035: Wrong analyte scanned............. CA-0036: Wrong kit type scanned ............ CA-0037: Wrong QC level scanned .......... CA-0038: QC lot expired ............................... CA-0039: Unknown QC lot scanned ........ CA-0040: TLS communication error ......... CA-0041: Database error .............................. CA-0042: User ID not found ........................ CA-0043: Patient ID not found.................... CA-0044: Measuring unit communication issue ..................................... CA-0045: Configuration update failed ..... 235 236 236 236 237 237 237 238 238 238 239 239 239 240 240 240 241 241 241 242 242 242 243 243 243 244 244 244 244 245 246 246 246 247 247 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 198 Table of contents CA-0048: Test strip lot not yet passed QC.......................................................................... CA-0050: Date / time settings lost ............ CA-0051: Invalid concentration value...... CA-0052: Invalid sample ID ......................... CA-0053: Strip lot data request timed out.......................................................................... CA-0054: Wrong kit type scanned ............ CA-0055: Wrong analyte scanned............. CA-0057: Linearity lot expired .................... CA-0058: Unknown linearity lot scanned ............................................................... CA-0059: Multiple test strip lots used for linearity test................................................. CA-0060: Manual test strip removal......... CA-0061: Insufficient user rights ............... CA-0062: Observer and logged-on user are identical ....................................................... CA-0063: QC / linearity lot rejected.......... CA-0064: Measuring unit communication error ...................................... CA-0066: Folder not deleted........................ CA-0067: Wi-Fi networks not deleted completely .......................................................... CA-0068: Instrument restart failed............ CA-0070: Invalid sample ID ......................... CA-0071: Invalid database encryption key ......................................................................... CA-0072: Database error .............................. CA-0073: Instrument was charged during measurement ...................................... CA-0074: Result database full .................... CA0075: Software error ................................. CA-0077: Internal storage error ................. CA-0078: TLS communication warning... CA-0079: Certificate backup failed........... CA-0080: Entry does not exist anymore .. CA-0081: Configuration by barcode error ...................................................................... CA-0082: Low battery .................................... CA-0083: Invalid user ID ............................... CA-0084: Invalid user ID ............................... CA-0085: Invalid user ID ............................... 247 248 248 248 249 249 249 250 250 250 251 251 251 252 252 252 253 253 253 254 254 254 255 255 255 256 256 257 257 257 258 258 258 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 199 CA-0086: Invalid user ID ............................... CA-0087: Invalid patient ID.......................... CA-0088: Invalid patient ID.......................... CA-0089: Invalid patient ID.......................... CA-0090: Invalid patient ID.......................... CA-0091: Invalid QC material barcode .... CA-0092: Invalid linearity material barcode................................................................ CA-0093: Invalid configuration barcode . CA-0094: Invalid configuration barcode . CA-0095: Invalid configuration barcode . CA-0096: Incompatible configuration barcode................................................................ CA-0097: Invalid configuration barcode . CA-0098: Invalid configuration barcode . CA-0100: Invalid configuration barcode . CA-0101: Invalid configuration barcode . CA-0102: Invalid configuration barcode . CA-0103: Invalid configuration barcode . CA-0104: Invalid configuration barcode . CA-0105: Data integrity test failed ............ CA-0106: Internal storage error detected............................................................... CA-0107: Result deletion failed.................. CA-0108: Database limit reached for QC lot codes ...................................................... CA-0109: Database limit reached for linearity lot codes............................................. CA-0110: Database limit reached for QC lots ................................................................. CA-0111: Database limit reached for linearity lots........................................................ CA-0113: Database limit reached for test strip lots ...................................................... CA-0114: Password too long....................... CA-0115: Invalid certificate configuration update ...................................... CA-0116: Different users log on as observer before and after OTS.................... CA-0117: Invalid barcode content............. CA-0118: Invalid platform interface detected............................................................... CA-0119: Patient ID not found.................... 259 259 260 260 260 261 261 261 262 262 262 263 263 263 264 264 264 264 265 265 265 266 266 266 267 267 268 268 268 269 269 269 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 200 Table of contents CA-0120: Invalid test strip container barcode................................................................ CA-0121: Linearity lot expired .................... CA-0122: Test strip lot expired ................... CA-0123: DMS host cannot be reached. CA-0124: DMS server certificate check failed ..................................................................... CA-0125: Instrument client certificate check failed........................................................ CA-0126: Generic DMS connection error ...................................................................... CA-0127: cobas infinity edge host cannot be reached .......................................... CA-0128: cobas infinity edge server certificate check failed................................... CA-0129: cobas infinity edge host name check failed ........................................... CA-0130: Instrument client certificate check failed........................................................ CA-0131: cobas infinity edge workflow expired.............................................. CA-0132: cobas infinity edge execution timeout ............................................ CA-0133: Negative cobas infinity edge command acknowledgment received ........................... CA-0134: Service data upload failed ........ CA-0135: Service log data upload failed CA-0136: Pseudonymization error............. CA-0137: Generic cobas infinity edge connection error............................................... CA-0138: Measuring range configuration error .......................................... MS-0002: Measuring unit error.................. MS-0003: Measuring unit error.................. MS-0004: Measuring unit error.................. MS-0005: Measuring unit error.................. MS-0006: Measuring unit error.................. MS-0007: Measuring unit error.................. MS-0008: SW update error .......................... MS-0010: Measuring unit error.................. MS-0011: Measuring unit error.................. MS-0012: Measuring unit error.................. 270 270 270 271 271 272 272 272 273 273 274 274 275 275 275 276 276 277 277 277 278 278 279 279 279 280 280 280 280 281 MS .................................................................................... s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 201 MS-0013: SW update error .......................... 281 MS-0015: Forced measuring unit shutdown ............................................................ MS-0016: Measuring unit error.................. MS-0017: Measuring unit error.................. MS-0018: Measuring unit error.................. MS-0019: SW update error .......................... MS-0020: Test strip ejection error............. MS-0021: Measuring unit error.................. MS-0022: SW update error .......................... MS-0023: Measuring unit error.................. MS-0024: Measuring unit error.................. MS-0025: Measuring unit error.................. MS-0026: Measuring unit error.................. MS-0027: Measuring unit error.................. MS-0028: Strip insertion period timed out.......................................................................... MS-0029: Dosing period timed out........... MS-0030: Unexpected system shutdown ............................................................ MS-0032: Measuring unit error.................. MS-0033: Test strip inserted during shutdown ............................................................ MS-0034: Measuring unit configuration error ...................................................................... MU-0090: Measuring unit error ................. MU-0091: Measuring unit error ................. MU-0092: Measuring unit error ................. MU-0094: Measuring unit error ................. MU-0095: Measuring unit error ................. MU-0096: Measuring unit error ................. MU-0097: Measuring unit error ................. MU-0098: Measuring unit error ................. MU-0120: Measuring unit error ................. MU-0130: Measuring unit error ................. MU-0131: Measuring unit error ................. MU-0132: Measuring unit error ................. MU-0133: Measuring unit error ................. MU-0134: Measuring unit error ................. MU-0135: Measuring unit error ................. 281 282 282 282 282 283 283 283 284 284 284 284 285 285 285 286 286 286 286 287 291 292 292 292 293 293 293 294 294 294 295 295 295 296 296 MU.................................................................................... s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 202 Table of contents MU-0136: Measuring unit error ................. MU-0137: Measuring unit error ................. MU-0138: Measuring unit error ................. MU-0139: Measuring unit error ................. MU-0140: Measuring unit error ................. MU-0141: Measuring unit error ................. MU-0142: Measuring unit error ................. MU-0143: Measuring unit error ................. MU-0145: Measuring unit error ................. MU-0146: Measuring unit error ................. MU-0147: Measuring unit error ................. MU-0148: Measuring unit error ................. MU-0149: Measuring unit error ................. MU-0150: Measuring unit error ................. MU-0151: Measuring unit error ................. MU-0152: Measuring unit error ................. MU-0153: Measuring unit error ................. MS-0156: Temperature too low.................. MU-0157: Temperature too high ............... MU-0158: Measuring unit error ................. MU-0159: Measuring unit error ................. MU-0160: Measuring unit error ................. MU-0161: Measuring unit error ................. MU-0162: Measuring unit error ................. MU-0163: Measuring unit error ................. MU-0165: Measuring unit error ................. MU-0167: Measuring unit error ................. MU-0168: Measuring unit error ................. MU-0169: Measuring unit error ................. MU-0170: Measuring unit error ................. MU-0171: Measuring unit error ................. MU-0172: Measuring unit error ................. MU-0173: Ambient temperature error..... MU-0174: Measuring unit error ................. MU-0175: Test strip mediator degradation fail-safe activated................... MU-0176: Reused test strip fail-safe activated .............................................................. MU-0178: Ascorbic-acid fail-safe activated .............................................................. 296 297 297 297 298 298 298 299 299 299 299 300 300 300 301 301 301 301 302 302 302 303 303 303 304 304 304 305 305 305 306 306 306 307 307 307 308 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 203 MU-0179: Voltage measurement fail-
safe activated .................................................... MU-0180: Measuring unit error ................. MU-0182: Measuring unit error ................. MU-0183: Measuring unit error ................. MU-0231: Test strip ejection error ............ MU-0232: Test strip ejection error ............ MU-0241: Test strip ejection error ............ MU-0242: Measuring unit error ................. MU-0243: Measuring unit error ................. MU-0245: Measuring unit error ................. MU-0246: Measuring unit error ................. MU-0247: Measuring unit error ................. MU-0249: Measuring unit error ................. MU-0250: Measuring unit error ................. MU-0251: Measuring unit error ................. MU-0252: Measuring unit error ................. MU-0253: Measuring unit error ................. MU-0254: Measuring unit error ................. MU-0256: Measuring unit error ................. MU-0257: Measuring unit error ................. MU-0258: Measuring unit error ................. MU-0259: Measuring unit error ................. MU-0260: Measuring unit error ................. MU-0261: Measuring unit error ................. MU-0262: Measuring unit error ................. MU-0263: Measuring unit error ................. MU-0267: Measuring unit error ................. MU-0273: Measuring unit error ................. MU-0320: Measuring unit error ................. MU-0321: Measuring unit error ................. MU-0323: Measuring unit error ................. MU-0324: Measuring unit error ................. MU-0325: Measuring unit error ................. MU-0326: Measuring unit error ................. MU-0327: Measuring unit error ................. MU-0328: Measuring unit error ................. MU-0329: Measuring unit error ................. MU-0340: Measuring unit error ................. MU-0341: Test strip ID decoding error ... 308 308 309 309 309 310 310 310 311 311 311 311 312 312 312 313 313 313 314 314 314 314 315 315 315 316 316 316 317 317 317 318 318 318 318 319 319 319 320 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 204 Table of contents MU-0342: Test strip ID decoding error ... MU-0343: Test strip insertion error........... MU-0345: Test strip inserted upside down ..................................................................... MU-0346: Measuring unit error ................. MU-0347: Measuring unit error ................. MU-0348: Measuring unit error ................. MU-0350: Measuring unit error ................. MU-0351: Measuring unit error ................. MU-0401: Measuring unit error ................. MU-0402: Measuring unit error ................. MU-0403: Measuring unit error ................. MU-0405: Measuring unit error ................. MU-0406: Measuring unit error ................. MU-0407: Measuring unit error ................. MU-0409: Measuring unit error ................. MU-0410: Measuring unit error ................. MU-0412: Measuring unit error ................. MU-0413: Measuring unit error ................. MU-0416: Measuring unit error ................. MU-0419: Measuring unit error ................. MU-0420: Measuring unit error ................. MU-0421: Measuring unit error ................. MU-0423: Measuring unit error ................. MU-0424: Measuring unit error ................. MU-0425: Measuring unit error ................. MU-0426: Measuring unit error ................. MU-0427: Measuring unit error ................. MU-0428: Measuring unit error ................. MU-0429: Measuring unit error ................. MU-0430: Measuring unit error ................. MU-0431: Measuring unit error ................. MU-0432: Measuring unit error ................. MU-0501: Measuring unit error ................. MU-0502: Measuring unit error ................. MU-0503: Measuring unit error ................. MU-0505: Measuring unit error ................. MU-0506: Measuring unit error ................. MU-0512: Measuring unit error ................. MU-0513: Measuring unit error ................. 320 320 321 321 321 322 322 322 322 323 323 323 324 324 324 325 325 325 326 326 326 327 327 327 328 328 328 329 329 329 330 330 330 331 331 331 332 332 332 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 205 MU-0514: Measuring unit error ................. MU-0515: Measuring unit error ................. MU-0521: Measuring unit error ................. MU-0523: Measuring unit error ................. MU-0524: Measuring unit error ................. MU-0525: Measuring unit error ................. MU-0526: Measuring unit error ................. MU-0527: Measuring unit error ................. MU-0528: Measuring unit error ................. MU-0529: Measuring unit error ................. MU-0541: Measuring unit error ................. MU-0560: Measuring unit fail-safe activated .............................................................. MU-0561: Measuring unit fail-safe activated .............................................................. MU-0562: Measuring unit fail-safe activated .............................................................. MU-0563: Measuring unit fail-safe activated .............................................................. MU-0564: Test strip fail-safe activated ... MU-0567: Measuring unit fail-safe activated .............................................................. MU-0901: Measuring unit error ................. MU-0905: Test strip contact error ............. MU-0906: Test strip contact error ............. MU-0910: Measuring unit error ................. MU-0930: Sample application error ......... MU-0940: Sample application error ......... MU-0941: Sample application error ......... MU-0945: Sample application error ......... MU-0947: Sample application error ......... MU-0951: Sample application error ......... MU-0952: Sample application error ......... MU-0960: Test strip error ............................. MU-0961: Test strip error ............................. MU-0962: Test strip error ............................. MU-0963: Test strip error ............................. MU-0971: Signal range violation ............... MU-0972: Signal range violation ............... MU-0973: Signal range violation ............... MU-0974: Signal range violation ............... 333 333 333 334 334 334 335 335 335 336 336 336 337 337 337 338 338 338 339 339 339 340 340 340 341 341 341 342 342 342 343 343 343 344 344 344 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 206 Table of contents US ..................................................................................... MU-0975: Signal range violation ............... MU-0976: Signal range violation ............... MU-0978: Signal range violation ............... MU-0979: Removal of test strip during test......................................................................... MU-0980: Signal range violation ............... MU-0981: Signal range violation ............... MU-0982: Signal range violation ............... MU-0983: Signal range violation ............... MU-0984: Signal range violation ............... MU-0987: Test strip insertion error........... US-0001: Unknown error .............................. US-0002: Software update package retrieval failed.................................................... US-0003: Invalid software update package ............................................................... US-0004: Measuring unit firmware update error ....................................................... US-0005: Measuring unit firmware update error ....................................................... US-0007: SW update error ........................... US-0008: Error during shutdown ............... US-0009: SW update error ........................... US-0010: Measuring unit error................... US-0011: Measuring unit error................... US-0012: High-level measuring unit firmware update failed................................... US-0013: Software update failed ............... US-0014: App update failed ........................ US-0016: Measuring unit software update error ....................................................... US-0017: Measuring unit software update error ....................................................... US-0018: Software update failed ............... US-0019: Operating system update failed ..................................................................... US-0020: Component compatibility check failed........................................................ US-0021: App uninstall failed ..................... US-0022: Software update already in process ................................................................ 345 345 345 346 346 346 347 347 347 348 348 349 349 350 350 350 351 351 351 352 352 352 353 353 353 354 354 354 355 355 355 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 207 US-0023: Software update package download failed ................................................ US-0024: Software update error ................ US-0025: Software update error ................ US-0026: Software update error ................ US-0027: Software update error ................ US-0028: Incompatible software update container ............................................................. 356 356 356 357 357 358 s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 208 Table of contents Page intentionally left blank. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 209 About level 1 messages and level 2 errors The cobas pulse user interface guides you through workflows based on the instrument configuration. Information, warning, and error screens indicate when cobas pulse detects specific conditions or events. Level 1 messages Level 1 messages are displayed on the user interface. They can also be retrieved by the DMS. There are 3 types of level 1 messages:
Information Warnings Errors Warnings and errors are triggered by an underlying level 2 error. Consequently a level 1 message will have one or more associated level 2 errors. A level 1 message contains the following information:
Message code (e.g., U-AN) Title Problem Guidance The severity of the message is color coded. Information: no color Warning: yellow Error: red Level 1 messages are displayed using the following formats:
Information (dialog) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 210 About level 1 messages and level 2 errors Warning (dialog) Warning with action (dialog) Error (dialog) Camera related message s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 211 Inline error below a text entry field As well as being displayed on the user interface, level 1 messages are listed in the audit trail (
> Audit trail). Level 1 messages are grouped by the nature of the underlying issue/error, and represented by a letter. The letter is incorporated in the message code (e.g., T-AB) Group Issue type H S D U E I C G B T O Environmental condition Hardware Sample Strip/instrument User System software Glucose app Generic errors RFID tag reading OTE app Barcode scanning (messages related to configuration by barcode) y Level 1 messages goups u Level 1 messages (213) s e g a s s e m r o r r E 9 Level 2 errors Level 2 errors indicate the issue underlying a level 1 message. Level 2 errors can be viewed using the following methods:
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Audit trailSettings changedUser logonInstrument cleaning performedWi-Fi association problemT-AB22-Mar-2020, 16:3122-Mar-2020, 15:2722-Mar-2020, 15:2721-Mar-2020, 10:1321-Mar-2020, 10:13RFID timeout 212 About level 1 messages and level 2 errors User assistance Instrument audit trail DMS You use the level 2 error code to locate the error message details in the User Assistance. When viewed in the User Assistance a level 2 error provides the following information:
Error code (e.g., CA-0010) Title Problem Solution Trace to the level 1 error message (e.g., G-AA) Using the instrument audit trail or the DMS, only the error code of the level 2 error is provided. To view an underlying level 2 error of a level 1 message, in the Audit trail screen, tap the level 1 message. The Audit trail details screen is displayed, containing the level 2 error code. u Level 2 errors (229) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Audit trail detailsRFID timeoutDate and timeDescription22-Mar-2020, 15:27Reading period has timed out. Ensuresufficient proximity.T-ABCA-0031 Error messages 213 Level 1 messages In this section B-AA: Invalid barcode(214) B-AB: Scan timeout(214) B-AC: Wrong sequence(215) B-AD: Configuration error(215) C-AA: Database full(215) C-AB: Database error(215) C-AD: Connection error(216) D-AA: Test strip error(216) D-AB: Lot expired(216) D-AE: Material expired(216) D-AF: Test strip error(217) D-AG: Insertion error(217) D-AH: Unknown lot(217) D-AJ: QC test required(217) D-AK: Insertion error(218) D-AL: Test strip error(218) D-AN: Unknown kit lot(218) D-AO: Test strip error(218) D-AP: Wrong lot(219) E-AA: Temperature too low(219) E-AB: Temperature too high(219) G-AA: Instrument error(219) G-AC: Process error(220) G-AE: Instrument error(220) H-AC: Low battery(220) H-AF: Date/time lost(220) H-AG: Ejection error(221) H-AJ: Battery version error(221) I-AC: Software update error(221) I-AE: Encryption error(222) I-AF: Software update error(222) I-AG: Synchronization failed(222) I-AH: Connection error(222) I-AJ: Encryption warning(223) S-AB: Sample application error(223) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 214 Level 1 messages S-AD: Sample type error(223) S-AF: Sample error(223) T-AA: Invalid RFID tag(224) T-AB: RFID timeout(224) U-AA: Invalid user ID(224) U-AB: Invalid password(224) U-AC: Patient not found(225) U-AD: Invalid observer(225) U-AE: Invalid patient ID(225) U-AF: User not found(225) U-AG: Unexpected bottle(226) U-AJ: User not found(226) U-AK: Patient not found(226) U-AL: Password too short(226) U-AM: Passwords do not match(227) U-AN: Inconsistent insulin value(227) U-AO: Invalid sample ID(227) U-AP: Invalid sample ID(227) U-AQ: Insufficient user rights(228) B-AA: Invalid barcode B-AB: Scan timeout s e g a s s e m r o r r E 9 Barcode is invalid. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Scanning period has timed out. Restart scanning Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 215 B-AC: Wrong sequence Wrong barcode scanned.*
Scan barcode %s of %s.*
*<individual barcode number> of <total number of barcodes>
Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Check barcode configuration content. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Ensure that the instrument is connected to the network. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Database was reset to the default settings. Ensure that the instrument is connected to the network. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 B-AD: Configuration error C-AA: Database full C-AB: Database error Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 216 Level 1 messages C-AD: Connection error D-AA: Test strip error D-AB: Lot expired D-AE: Material expired s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Test strip lot data retrieval not possible. Ensure that the instrument is connected to the network. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Repeat the test with a new test strip. Severity GUI Warning DMS Critical u About level 1 messages and level 2 errors (209) Repeat the test with a test strip from a valid lot. Severity GUI Warning DMS Warning u About level 1 messages and level 2 errors (209) Use material from a valid lot to continue. Severity GUI Warning DMS Warning u About level 1 messages and level 2 errors (209) D-AF: Test strip error D-AG: Insertion error Error messages 217 Repeat the test with a new test strip. Follow proper usage in the handling recommendations. Severity GUI Warning DMS Critical u About level 1 messages and level 2 errors (209) Eject the test strip and insert it correctly. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) D-AH: Unknown lot Ensure that a correct test strip lot is used. u About level 1 messages and level 2 errors (209) D-AJ: QC test required Severity GUI Warning DMS Warning Perform a QC test. Severity GUI Warning DMS Warning u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 218 Level 1 messages D-AK: Insertion error D-AL: Test strip error D-AN: Unknown kit lot D-AO: Test strip error s e g a s s e m r o r r E 9 Eject the test strip and insert it again when requested. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Test strip was removed during the test. Repeat the test with a new test strip. Do not remove the test strip during processing. u About level 1 messages and level 2 errors (209) Severity GUI Warning DMS Note Unknown kit lot. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Always use the eject button to remove the test strip. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 219 D-AP: Wrong lot E-AA: Temperature too low E-AB: Temperature too high G-AA: Instrument error Use the same test strip lot for all linearity test levels. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Testing not possible. Use the instrument at a higher temperature. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Testing not possible. Use the instrument at a lower temperature. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Turn off and restart the instrument. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 220 Level 1 messages G-AC: Process error G-AE: Instrument error H-AC: Low battery H-AF: Date/time lost s e g a s s e m r o r r E 9 Repeat the test with a new test strip. Severity GUI Warning DMS Warning u About level 1 messages and level 2 errors (209) u About level 1 messages and level 2 errors (209) Action is not possible. Severity GUI Warning DMS Warning Charge the instrument. Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) Enter the date and time before performing new tests. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 H-AG: Ejection error H-AJ: Battery version error Error messages 221 Eject the test strip using the eject button. If the problem persists, remove the test strip manually. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Due to the nature of this issue, only the ID (H-AJ) of the message is displayed on the screen. Incompatible battery detected. The instrument cannot be used. Contact your Roche representative. u Replacing the battery (177) u About level 1 messages and level 2 errors (209) I-AC: Software update error Instrument cannot be used. Ensure that the instrument is connected to the network. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 222 Level 1 messages I-AE: Encryption error I-AF: Software update error I-AG: Synchronization failed I-AH: Connection error s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 An encryption error occurred. Results cannot be synchronized. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) A software update error occurred. Severity GUI Information DMS Warning u About level 1 messages and level 2 errors (209) Synchronization with the DMS failed. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Connection to cobas infinity edge was interrupted. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) I-AJ: Encryption warning S-AB: Sample application error S-AD: Sample type error S-AF: Sample error Error messages 223 An encryption warning ocurred. Results are still being synchronized. Severity GUI Warning DMS Warning u About level 1 messages and level 2 errors (209) Repeat the test with a new test strip. Apply sufficient sample when requested without moving the test strip. Severity GUI Warning DMS Warning u About level 1 messages and level 2 errors (209) Repeat the test with a new test strip. Apply the following sample type: %s*
* %s = sample type (dependant on workflow i.e., blood, QC material, linearity material) Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Repeat the test with a new test strip. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 224 Level 1 messages T-AA: Invalid RFID tag T-AB: RFID timeout U-AA: Invalid user ID U-AB: Invalid password s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Read a correct RFID tag. Severity GUI Error DMS Warning u About level 1 messages and level 2 errors (209) Reading period has timed out. Ensure sufficient proximity. u About level 1 messages and level 2 errors (209) Severity GUI Warning DMS Note User ID is invalid. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) Password entered is invalid. Severity GUI Error DMS Warning u About level 1 messages and level 2 errors (209) Error messages 225 U-AC: Patient not found U-AD: Invalid observer Patient ID was not found. Severity GUI Error DMS Warning u About level 1 messages and level 2 errors (209) u About level 1 messages and level 2 errors (209) U-AE: Invalid patient ID Invalid observer Severity GUI DMS Error Note Patient ID is invalid. Severity GUI Error DMS Critical U-AF: User not found u About level 1 messages and level 2 errors (209) User ID was not found. Severity GUI Error DMS Critical u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 226 Level 1 messages U-AG: Unexpected bottle Scan bottle: %s, %s.*
* <kit type>, <kit level>
Dependant on the workflow:
<kit type> = QC or Linearity
<kit level> = Individual level number (e.g., 1 or 2 for QC) Severity GUI Warning DMS Note u About level 1 messages and level 2 errors (209) U-AJ: User not found u About level 1 messages and level 2 errors (209) U-AK: Patient not found u About level 1 messages and level 2 errors (209) U-AL: Password too short s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 u About level 1 messages and level 2 errors (209) User was not found. Severity GUI Error DMS Critical Patient was not found. Severity GUI Error DMS Warning Password is too short. Severity GUI DMS Error Note U-AM: Passwords do not match U-AN: Inconsistent insulin value U-AO: Invalid sample ID Error messages 227 Passwords do not match. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Value must be greater than 0 and less than 50 (maximum one decimal place). Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) Sample ID is invalid. Severity GUI DMS Error Note Sample ID is invalid. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 u About level 1 messages and level 2 errors (209) U-AP: Invalid sample ID Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 228 Level 1 messages U-AQ: Insufficient user rights Action is not allowed. Severity GUI DMS Error Note u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 229 Level 2 errors CA In this section CA(229) MS(277) MU(287) US(348) In this section CA-0001: Unknown error(232) CA-0002: Database access error(233) CA-0003: Database access error(233) CA-0004: Measuring unit communication error(233) CA-0005: Measuring unit communication error(234) CA-0006: Access to internal storage failed(234) CA-0007: Software error(234) CA-0008: Test strip lot information not found(235) CA-0009: Test strip lot expired(235) CA-0010: Communication with measuring unit interrupted(235) CA-0011: Software error(236) CA-0012: Synchronization with DMS failed(236) CA-0013: Test strip inserted too early(236) CA-0014: Test strip ID not recognized(237) CA-0015: Error during Glucose app startup(237) CA-0016: Barcode with invalid ID scanned(237) CA-0017: QC lot expired(238) CA-0019: User ID not found(238) CA-0020: Patient ID not found(238) CA-0021: RFID tag invalid(239) CA-0022: Invalid password(239) CA-0023: Invalid patient ID(239) CA-0024: Password too short(240) CA-0025: Passwords do not match(240) CA-0026: Invalid insulin units(240) CA-0027: Invalid insulin units(241) CA-0028: Invalid user ID(241) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 230 Level 2 errors CA-0029: User ID not found(241) CA-0030: Scan timeout(242) CA-0031: RFID timeout(242) CA-0032: Incorrect sample applied in a QC test or linearity test(242) CA-0033: Incorrect sample applied in a glucose test(243) CA-0034: Wrong barcode sequence(243) CA-0035: Wrong analyte scanned(243) CA-0036: Wrong kit type scanned(244) CA-0037: Wrong QC level scanned(244) CA-0038: QC lot expired(244) CA-0039: Unknown QC lot scanned(244) CA-0040: TLS communication error(245) CA-0041: Database error(246) CA-0042: User ID not found(246) CA-0043: Patient ID not found(246) CA-0044: Measuring unit communication issue(247) CA-0045: Configuration update failed(247) CA-0048: Test strip lot not yet passed QC(247) CA-0050: Date / time settings lost(248) CA-0051: Invalid concentration value(248) CA-0052: Invalid sample ID(248) CA-0053: Strip lot data request timed out(249) CA-0054: Wrong kit type scanned(249) CA-0055: Wrong analyte scanned(249) CA-0057: Linearity lot expired(250) CA-0058: Unknown linearity lot scanned(250) CA-0059: Multiple test strip lots used for linearity test(250) CA-0060: Manual test strip removal(251) CA-0061: Insufficient user rights(251) CA-0062: Observer and logged-on user are identical(251) CA-0063: QC / linearity lot rejected(252) CA-0064: Measuring unit communication error(252) CA-0066: Folder not deleted(252) CA-0067: Wi-Fi networks not deleted completely(253) CA-0068: Instrument restart failed(253) CA-0070: Invalid sample ID(253) CA-0071: Invalid database encryption key(254) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 231 CA-0072: Database error(254) CA-0073: Instrument was charged during measurement(254) CA-0074: Result database full(255) CA0075: Software error(255) CA-0077: Internal storage error(255) CA-0078: TLS communication warning(256) CA-0079: Certificate backup failed(256) CA-0080: Entry does not exist anymore(257) CA-0081: Configuration by barcode error(257) CA-0082: Low battery(257) CA-0083: Invalid user ID(258) CA-0084: Invalid user ID(258) CA-0085: Invalid user ID(258) CA-0086: Invalid user ID(259) CA-0087: Invalid patient ID(259) CA-0088: Invalid patient ID(260) CA-0089: Invalid patient ID(260) CA-0090: Invalid patient ID(260) CA-0091: Invalid QC material barcode(261) CA-0092: Invalid linearity material barcode(261) CA-0093: Invalid configuration barcode(261) CA-0094: Invalid configuration barcode(262) CA-0095: Invalid configuration barcode(262) CA-0096: Incompatible configuration barcode(262) CA-0097: Invalid configuration barcode(263) CA-0098: Invalid configuration barcode(263) CA-0100: Invalid configuration barcode(263) CA-0101: Invalid configuration barcode(264) CA-0102: Invalid configuration barcode(264) CA-0103: Invalid configuration barcode(264) CA-0104: Invalid configuration barcode(264) CA-0105: Data integrity test failed(265) CA-0106: Internal storage error detected(265) CA-0107: Result deletion failed(265) CA-0108: Database limit reached for QC lot codes(266) CA-0109: Database limit reached for linearity lot codes(266) CA-0110: Database limit reached for QC lots(266) CA-0111: Database limit reached for linearity lots(267) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 232 Level 2 errors CA-0113: Database limit reached for test strip lots(267) CA-0114: Password too long(268) CA-0115: Invalid certificate configuration update(268) CA-0116: Different users log on as observer before and after OTS(268) CA-0117: Invalid barcode content(269) CA-0118: Invalid platform interface detected(269) CA-0119: Patient ID not found(269) CA-0120: Invalid test strip container barcode(270) CA-0121: Linearity lot expired(270) CA-0122: Test strip lot expired(270) CA-0123: DMS host cannot be reached(271) CA-0124: DMS server certificate check failed(271) CA-0125: Instrument client certificate check failed(272) CA-0126: Generic DMS connection error(272) CA-0127: cobas infinity edge host cannot be reached(272) CA-0128: cobas infinity edge server certificate check failed(273) CA-0129: cobas infinity edge host name check failed(273) CA-0130: Instrument client certificate check failed(274) CA-0131: cobas infinity edge workflow expired(274) CA-0132: cobas infinity edge execution timeout(275) CA-0133: Negative cobas infinity edge command acknowledgment received(275) CA-0134: Service data upload failed(275) CA-0135: Service log data upload failed(276) CA-0136: Pseudonymization error(276) CA-0137: Generic cobas infinity edge connection error(277) CA-0138: Measuring range configuration error(277) CA-0001: Unknown error s e g a s s e m r o r r E 9 Problem An unknown error occured. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 233 Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0002: Database access error CA-0003: Database access error Problem A database access error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A database access error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0004: Measuring unit communication error Problem The instrument was not able to communicate with the measuring unit Solution Restart the instrument and try again. Related L1 message G-AA Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 234 Level 2 errors u About level 1 messages and level 2 errors (209) CA-0005: Measuring unit communication error Problem The instrument was not able to communicate with the measuring unit. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0006: Access to internal storage failed CA-0007: Software error Problem The instrument was not able to access its internal storage. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The instrument is defective and cannot be used for testing. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 235 CA-0008: Test strip lot information not found Problem The lot information of the inserted test strip is missing. The inserted test strip cannot be used Solution Add the unknown test strip lot to the instrument database by using one of the following methods:
Scan the strip vial container and let the instrument request the lot from cobas infinity edge. Scan the complete lot information via a configuration barcode (generated in the cobas infinity edge management portal). If the lot is already known in the DMS, configure the DMS to upload the lot information to the instrument. Alternatively the user could use a test strip from a known/valid test strip lot. Related L1 message D-AH u About level 1 messages and level 2 errors (209) CA-0009: Test strip lot expired Problem The used test strip lot is expired. Solution Repeat the test with a test strip from a valid lot. Related L1 message D-AB u About level 1 messages and level 2 errors (209) CA-0010: Communication with measuring unit interrupted Problem The communication with the measuring unit was interrupted. Solution Restart the instrument and try again. Related L1 message G-AA Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 236 Level 2 errors CA-0011: Software error CA-0012: Synchronization with DMS failed u About level 1 messages and level 2 errors (209) Problem The instrument is defective and cannot be used for testing. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The synchronization with the DMS failed. The instrument cannot transmit results or receive updated data from the DMS. Solution Ensure that the instrument is connected to the network and the DMS. Check the connectivity and availability of the DMS using the network status test. Related L1 message I-AG u About level 1 messages and level 2 errors (209) Problem The test strip was inserted too early. Solution Eject the test strip and insert it again when requested. Related L1 message D-AK u About level 1 messages and level 2 errors (209) CA-0013: Test strip inserted too early s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 237 CA-0014: Test strip ID not recognized CA-0015: Error during Glucose app startup Problem The instrument was not able to read the test strip ID (e.g. due to dirt or scratches). Solution Eject the current test strip and insert a new test strip. If the problem persists, contact your Roche representative. Related L1 message D-AH u About level 1 messages and level 2 errors (209) Problem An error occured during the startup of the Glucose app. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0016: Barcode with invalid ID scanned Problem The user scanned an ID that does not comply to the configured patterns for the user ID or patient ID, and is rated as invalid by the instrument. Solution Check if the ID which was rejected by the instrument complies to the intended ID patterns (length, structure, allowed values). Adapt the configured ID patterns (via DMS or via "configuration by barcode") if the scanned barcode shall be accepted by the instrument. Related L1 message B-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 238 Level 2 errors CA-0017: QC lot expired CA-0019: User ID not found Problem The QC lot used has expired. Solution Repeat the test using a valid QC lot. Related L1 message D-AE u About level 1 messages and level 2 errors (209) Problem The scanned user ID is unknown to the instrument. Solution Ensure that the instrument is connected to the network and the DMS. Check the connectivity and availability of the DMS using the network status test. Ensure that the DMS synchronizes the user list with the instrument. Related L1 message U-AJ u About level 1 messages and level 2 errors (209) Problem The scanned patient ID is unknown to the instrument. Solution Ensure that the instrument is connected to the network and the DMS. Check the connectivity and availability of the DMS using the network status test. Ensure that the DMS synchronizes the patient list with the instrument. Related L1 message U-AK u About level 1 messages and level 2 errors (209) CA-0020: Patient ID not found s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 239 CA-0021: RFID tag invalid CA-0022: Invalid password Problem An unsupported RFID tag was read. Solution Only use supported RFID tags. Related L1 message T-AA u About level 1 messages and level 2 errors (209) Problem The user entered an invalid password. Solution Enter a valid password. If the password has been changed recently, it might take a moment until it is propagated to all other instruments. Related L1 message U-AB u About level 1 messages and level 2 errors (209) CA-0023: Invalid patient ID Problem The user entered an patient ID that does not comply to the configured patterns for the patient ID. Solution Check if the entered patient ID which was rejected by the instrument complies to the intended patient ID pattern (length, structure, allowed values). Adapt the configured pattern if the patient ID entered shall be accepted by the instrument. Related L1 message U-AE u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 240 Level 2 errors CA-0024: Password too short CA-0025: Passwords do not match Problem The password entered is shorter than the configured minimal password length. Solution Enter a password that has the same or more characters than the configured minimal password length value. Related L1 message U-AL u About level 1 messages and level 2 errors (209) Problem While changing the user password on the instrument user interface, the user has entered two passwords that do not match. Solution Enter both new passwords (without any errors) in order to change the user password. Related L1 message U-AM u About level 1 messages and level 2 errors (209) Problem The user entered an invalid value for the insulin units. Solution Enter a valid insulin value that is greater than 0 and less than 50 (maximum 1 decimal place). Related L1 message U-AN u About level 1 messages and level 2 errors (209) CA-0026: Invalid insulin units s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 241 CA-0027: Invalid insulin units CA-0028: Invalid user ID Problem The user entered an value for the insulin units that contains more than one decimal place. Solution Enter a valid insulin value what contains maximum 1 decimal place. Related L1 message U-AN u About level 1 messages and level 2 errors (209) Problem The user entered a user ID that does not comply to the configured pattern for the user ID. Solution Check if the entered user ID which was rejected by the instrument complies to the intended user ID pattern
(length, structure, allowed values). Adapt the configured pattern if the entered user ID shall be accepted by the instrument. Related L1 message U-AA u About level 1 messages and level 2 errors (209) CA-0029: User ID not found Problem The scanned user ID is unknown to the instrument. Solution Ensure that the instrument is connected to the network. Check the connectivity and availability of the DMS using the network status test. Ensure that the DMS synchronizes the user list with the instrument. s e g a s s e m r o r r E 9 Related L1 message U-AJ Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 242 Level 2 errors CA-0030: Scan timeout CA-0031: RFID timeout u About level 1 messages and level 2 errors (209) Problem The barcode scanning period has timed out. Either the user did not scan the barcode correctly or the user tried to scan a barcode type which is deactivated in the instrument configuration. Solution Restart the barcode scanning and ensure that the barcode is visible in the scan area on the instrument screen. Related L1 message B-AB u About level 1 messages and level 2 errors (209) Problem The RFID tag reading period has timed out. Either the user placed the RFID tag too far away from the instrument or the user tried to scan an unsupported RFID tag. Solution Restart the RFID tag reading and ensure sufficient proximity. Related L1 message T-AB u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 CA-0032: Incorrect sample applied in a QC test or linearity test Problem The user applied blood to the test strip instead of QC material or linearity material. Solution Eject the current test strip and repeat the test with the corresponding QC material or linearity material. Related L1 message S-AD Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 243 u About level 1 messages and level 2 errors (209) CA-0033: Incorrect sample applied in a glucose test CA-0034: Wrong barcode sequence Problem The user applied QC material or linearity material to the test strip instead of blood. Solution Eject the current test strip and repeat the test with blood. Related L1 message S-AD u About level 1 messages and level 2 errors (209) Problem The user scanned the barcodes for configuration in the wrong order. Solution Scan the barcodes in the indicated order. Related L1 message B-AC u About level 1 messages and level 2 errors (209) CA-0035: Wrong analyte scanned Problem The user scanned a QC material that does not match the selected analyte. Solution Scan the correct QC material that corresponds to the selected analyte. Related L1 message U-AG u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 244 Level 2 errors CA-0036: Wrong kit type scanned CA-0037: Wrong QC level scanned CA-0038: QC lot expired Problem The user scanned a linearity material bottle instead of a QC material bottle. Solution Scan the correct QC material bottle. Related L1 message U-AG u About level 1 messages and level 2 errors (209) Problem The user scanned a QC material bottle that did not match the selected QC level. Solution Scan the correct QC material level to continue the workflow. Related L1 message U-AG u About level 1 messages and level 2 errors (209) Problem The lot of the scanned QC material has expired. Solution Use a valid QC lot. Related L1 message D-AE u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 CA-0039: Unknown QC lot scanned Problem The scanned QC lot is not available on this instrument. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 245 Solution Add the lot to the instrument database on the instrument in Settings > Lot management. Ensure that the instrument is connected to the network in order to enable the DMS to synchronize the kit lot database on the instrument. Related L1 message D-AN u About level 1 messages and level 2 errors (209) CA-0040: TLS communication error Problem The TLS (Transport Layer Security) handshake between the DMS and the instrument failed. The instrument cannot transmit results or receive updated data from the DMS. Possible reasons:
Configuration issue (e.g., the configured certificate of the DMS (stored in the DMS TLS certificate) has expired. Cybersecurity issue (e.g., man-in-the-middle attack). Solution Check the certificate stored in the DMS TLS certificate. If the configured certificate has expired, update the certificate and set the DMS TLS certificate check configuration item to Strict again. Check the connection between the instrument and the DMS using the Network status test option. Check your network infrastructure for breaches. Connect the instrument to a separate network and set the DMS TLS certificate check configuration item to
> Warning in order to allow a connection to the DMS. Related L1 message I-AE u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 246 Level 2 errors CA-0041: Database error CA-0042: User ID not found Problem A database error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The entered user ID is unknown to the instrument. Solution Ensure that the instrument is connected to the network. Check the connectivity and availability of the DMS using the network status test. Ensure that the DMS synchronizes the user list with the instrument. Related L1 message U-AF u About level 1 messages and level 2 errors (209) Problem The entered patient ID is unknown to the instrument. Solution Ensure that the instrument is connected to the network. Check the connectivity and availability of the DMS using the network status test. Ensure that the DMS synchronizes the user list with the instrument. Related L1 message U-AC u About level 1 messages and level 2 errors (209) CA-0043: Patient ID not found s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 247 CA-0044: Measuring unit communication issue CA-0045: Configuration update failed Problem The instrument was not able to start up the measuring unit. Solution Go to the app library and open the Glucose app again. If the problem persists, restart the instrument. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The configuration barcode could not be processed. Solution Check the contents of the configuration barcode and ensure that the configuration barcode is compatible with the instrument SW version. Related L1 message B-AD u About level 1 messages and level 2 errors (209) CA-0048: Test strip lot not yet passed QC Problem The inserted test strip belongs to a test strip lot that has not passed the required QC tests yet. Solution Required QC tests for new test strip lots is defined in the QC algorithm settings. Perform all required QC tests with test strips of this lot to unlock the test strip lot for patient testing or use test strip of a lot that already has passed all QC tests. Related L1 message D-AJ u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 248 Level 2 errors CA-0050: Date / time settings lost CA-0051: Invalid concentration value Problem The current date/time settings are lost (e.g., due to loss of power/battery change). Solution Enter the date and time manually and ensure that the instrument is connected to the network. Related L1 message H-AF u About level 1 messages and level 2 errors (209) Problem The measuring unit was not able to quantify the concentration of the measured sample. Solution Eject the test strip and repeat the test with a new test strip. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0052: Invalid sample ID s e g a s s e m r o r r E 9 Problem The entered sample ID for the proficiency material is not valid. Solution Enter a valid sample ID. The sample ID must contain between 1 and 20 printable characters (including white space). Related L1 message U-AO u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 249 CA-0053: Strip lot data request timed out Problem The instrument was not able to retrieve the strip lot data from cobas infinity edge. Solution Ensure that the instrument is connected to the network. Check that the instrument is connected to cobas infinity edge using the network status test. Related L1 message C-AD u About level 1 messages and level 2 errors (209) Problem The user scanned a QC material bottle instead of a linearity material bottle. Solution Scan the correct linearity material bottle. Related L1 message U-AG u About level 1 messages and level 2 errors (209) CA-0054: Wrong kit type scanned CA-0055: Wrong analyte scanned Problem The user scanned a linearity material does not match the selected analyte. Solution Scan the correct linearity material that corresponds to the analyte. Related L1 message U-AG u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 250 Level 2 errors CA-0057: Linearity lot expired CA-0058: Unknown linearity lot scanned Problem The lot of the scanned linearity material has expired. Solution Use a valid linearity lot. Related L1 message D-AE u About level 1 messages and level 2 errors (209) Problem The scanned linearity lot is not available on this instrument. Solution Add the lot to the instrument database on the instrument using Settings > Lot management. Ensure that the instrument is connected to the network in order to enable the DMS to sync the kit lot database on the instrument. Related L1 message D-AN u About level 1 messages and level 2 errors (209) Problem The user has inserted a test strip which is from a different test strip lot than the strips used for the previous linearity test steps. The user must use a strip from the same test strip lot for all steps in a linearity test. Solution For linearity tests, always use test strips from the same test strip lot. Related L1 message D-AP u About level 1 messages and level 2 errors (209) CA-0059: Multiple test strip lots used for linearity test s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 251 CA-0060: Manual test strip removal CA-0061: Insufficient user rights Problem The user removed the test strip manually without using the eject button on the user interface. This can damage the instrument and must be avoided. Solution Never pull out the test strip manually. Always us the eject button to remove the test strip. Related L1 message D-AO u About level 1 messages and level 2 errors (209) Problem The user doesn't have the privileges to perform the requested action (e.g., being an observer for the observed test sequence). Solution To allow the requested action, grant the required user rights to the user ID in the DMS. Ensure that the instrument is connected to the network and the DMS synchronizes the required user rights with the instrument. Related L1 message U-AQ u About level 1 messages and level 2 errors (209) CA-0062: Observer and logged-on user are identical Problem The logged-on user tried to act as observer in the observed test sequence (OTS). The logged-on user and the observer cannot be the same person. Solution Perform the observed test sequence (OTS) with two different users. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 252 Level 2 errors CA-0063: QC / linearity lot rejected Another user with the user role
"Observer" (OTS_OBSERVER) needs to log on during the observed test sequence. Related L1 message U-AD u About level 1 messages and level 2 errors (209) Problem The user tried to add a QC or linearity lot of which the target ranges are not known to the instrument. Solution Ensure that the instrument receives the updated target ranges either via barcode scanning or via DMS before you add this QC or linearity lot. Related L1 message D-AN u About level 1 messages and level 2 errors (209) Problem The instrument was not able to communicate with the measuring unit. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0064: Measuring unit communication error CA-0066: Folder not deleted s e g a s s e m r o r r E 9 Problem The Glucose app could not delete a folder from the file system. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 253 Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0067: Wi-Fi networks not deleted completely Problem The instrument could not delete all stored Wi-Fi networks after the user tapped the Delete instrument data button. Solution Restart the instrument and trigger the deletion of all instrument data in the GUI again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The instrument could not be restarted. Solution Restart the instrument. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0068: Instrument restart failed CA-0070: Invalid sample ID Problem The scanned sample ID for the proficiency material is not valid. Solution Scan a valid sample ID. The sample ID must contain between 1 and 20 printable characters (including white space). s e g a s s e m r o r r E 9 Related L1 message U-AP Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 254 Level 2 errors u About level 1 messages and level 2 errors (209) CA-0071: Invalid database encryption key CA-0072: Database error Problem The instrument detected corrupted data in its database and has reset the database to the default settings. Solution Ensure that the instrument is connected to the network and the DMS and that the instrument synchronizes the configuration, patient, user, and lot data. Related L1 message C-AB u About level 1 messages and level 2 errors (209) Problem A database error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The instrument was placed into the charging station while a measurement was in progress. The measurement failed. Solution Do not place the instrument into the charging station during a measurement. Related L1 message G-AC u About level 1 messages and level 2 errors (209) CA-0073: Instrument was charged during measurement s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 255 CA-0074: Result database full Problem One of the result database tables is full and the instrument is not able to store additional results. No further tests can be performed. Solution Ensure that the instrument is connected to the network and the DMS and that the instrument synchronizes the configuration, patient, user, and lot data. Check the settings of the following configuration items:
Result deletion algorithm Result retention period (in days) Result upload required before result deletion Related L1 message C-AA u About level 1 messages and level 2 errors (209) Problem The instrument is defective and cannot be used for testing. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA0075: Software error CA-0077: Internal storage error Problem An error with the internal storage of the instrument occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Related L1 message G-AA Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 256 Level 2 errors u About level 1 messages and level 2 errors (209) CA-0078: TLS communication warning Problem The TLS (Transport Layer Security) handshake between the DMS and the instrument failed. The instrument still transmits results and receives updated data from the DMS. Possible reasons:
Configuration issue (e.g., the configured certificate of the DMS (stored in the DMS TLS certificate) has expired. Cybersecurity issue (e.g., man-in-the-middle attack). Solution Check the certificate stored in the DMS TLS certificate. If the configured certificate has expired, update the certificate and set the DMS TLS certificate check configuration item to Strict again. Check the connection between the instrument and the DMS using the network status test. Check your network infrastructure for breaches. Connect the instrument to a separate network and set the DMS TLS certificate check configuration item to
> Warning in order to allow a connection to the DMS. Related L1 message I-AJ u About level 1 messages and level 2 errors (209) CA-0079: Certificate backup failed Problem The instrument could not backup the instruments security certificates. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 257 Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0080: Entry does not exist anymore CA-0081: Configuration by barcode error Problem The user tried to access a database entry or result which has been deleted either by the instrument deletion algorithm or by the DMS. Solution No action needed. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The user scanned a barcode that does not belong to the current barcode sequence for the configuration by barcode (e.g., user scanned an outdated barcode from an older barcode sequence). Solution Continue scanning the barcode from the correct barcode sequence or abort the barcode sequence and restart the scanning process. Related L1 message B-AC u About level 1 messages and level 2 errors (209) CA-0082: Low battery Problem No test can be performed due to low battery. Solution Place the instrument in the charging station in order to charge the battery to a sufficient level. Related L1 message H-AC Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 258 Level 2 errors CA-0083: Invalid user ID CA-0084: Invalid user ID u About level 1 messages and level 2 errors (209) Problem The user read a user ID via barcode that does not comply to the configured patterns for the user ID. The scanned ID is invalid. Solution Check if the ID complies with the intended ID patterns
(length, structure, allowed values). Adapt the configured ID patterns (via the DMS or by using the Configuration by barcode option) so that the scanned barcode will be accepted by the instrument. Related L1 message B-AA u About level 1 messages and level 2 errors (209) Problem The user read a user ID via barcode that does not comply with the maximum length allowed for the user ID. The scanned ID is invalid. Solution Check if the user ID violates the maximum length allowed of 20 characters. Reduce the ID length to maximum 20 characters. Related L1 message B-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 CA-0085: Invalid user ID Problem The user read a user ID via RFID tag that does not comply to the configured patterns for the user ID. The scanned ID is invalid. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 259 CA-0086: Invalid user ID Solution Check if the ID complies with the intended ID patterns
(length, structure, allowed values). Adapt the configured ID patterns (via the DMS or by using the Configuration by barcode option) so that the scanned barcode will be accepted by the instrument. Related L1 message T-AA u About level 1 messages and level 2 errors (209) Problem The user read an ID via RFID tag that does not comply with the maximum length allowed for the user ID. The scanned ID is invalid. Solution Check if the user ID violates the maximum length allowed of 20 characters. Reduce the ID length to maximum 20 characters. Related L1 message T-AA u About level 1 messages and level 2 errors (209) CA-0087: Invalid patient ID Problem The user read a patient ID via barcode that does not match the configured validation pattern and is rejected by the instrument. Solution Check if the ID complies with the intended ID patterns
(length, structure, allowed values). Adapt the configured ID patterns (via the DMS or by using the Configuration by barcode option) so that the scanned barcode will be accepted by the instrument. s e g a s s e m r o r r E 9 Related L1 message B-AA Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 260 Level 2 errors u About level 1 messages and level 2 errors (209) CA-0088: Invalid patient ID CA-0089: Invalid patient ID Problem The user read a user ID via barcode that does not comply with the maximum length allowed for the user ID. The scanned ID is invalid. Solution Check if the user ID violates the maximum length allowed of 20 characters. Reduce the ID length to maximum 20 characters. Related L1 message B-AA u About level 1 messages and level 2 errors (209) Problem The user read an ID via RFID tag that does not comply with the configured patterns for the patient ID. The scanned ID is invalid. Solution Check if the ID complies with the intended ID patterns
(length, structure, allowed values). Adapt the configured ID patterns (via the DMS or by using the Configuration by barcode option) so that the scanned barcode will be accepted by the instrument. Related L1 message T-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 CA-0090: Invalid patient ID Problem The user read an ID via RFID tag that does not comply to the maximum allowed length for the patient ID. The scanned ID is invalid. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 261 Solution Check if the user ID violates the maximum length allowed of 20 characters. Reduce the ID length to maximum 20 characters. Related L1 message T-AA u About level 1 messages and level 2 errors (209) Problem The scanned QC material barcode is invalid (e.g., incorrect format). Solution Ensure that you scan a QC material barcode intended for use with the cobas pulse instrument. Related L1 message B-AA u About level 1 messages and level 2 errors (209) Problem The scanned linearity material barcode is invalid (e.g., incorrect format). Solution Ensure that you scan a linearity material barcode intended for use with the cobas pulse instrument. Related L1 message B-AA u About level 1 messages and level 2 errors (209) CA-0091: Invalid QC material barcode CA-0092: Invalid linearity material barcode CA-0093: Invalid configuration barcode Problem The configuration barcode scanned does not contain any configuration items. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 262 Level 2 errors Solution Check the configuration settings in cobas infinity edge. Related L1 message B-AA u About level 1 messages and level 2 errors (209) CA-0094: Invalid configuration barcode CA-0095: Invalid configuration barcode Problem Changing of the result unit in your country is not allowed. No configuration change was applied. Solution Ensure that the configuration barcode does change the result unit. Related L1 message B-AD u About level 1 messages and level 2 errors (209) Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 CA-0096: Incompatible configuration barcode Problem The configuration barcode scanned is not compatible with cobas pulse. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 263 Related L1 message B-AD u About level 1 messages and level 2 errors (209) CA-0097: Invalid configuration barcode CA-0098: Invalid configuration barcode Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) CA-0100: Invalid configuration barcode Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 264 Level 2 errors CA-0101: Invalid configuration barcode CA-0102: Invalid configuration barcode CA-0103: Invalid configuration barcode Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) Problem The configuration barcode scanned is invalid. Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 CA-0104: Invalid configuration barcode Problem The configuration barcode scanned is invalid. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 CA-0105: Data integrity test failed Error messages 265 Solution Check the configuration settings in cobas infinity edge and try again with a newly generated barcode. Related L1 message B-AD u About level 1 messages and level 2 errors (209) Problem The instrument detected corrupted data in its database and has reset the database to the default settings. Solution Ensure that the instrument is connected to the network and the DMS, and that the instrument synchronizes the configuration, patient, user, and lot data. Related L1 message C-AB u About level 1 messages and level 2 errors (209) Problem An error with the internal storage of the instrument occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0107: Result deletion failed Problem One of the result database tables is full and the instrument was not able to delete a stored result. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 CA-0106: Internal storage error detected 266 Level 2 errors CA-0108: Database limit reached for QC lot codes Solution Ensure that the instrument is connected to the network and the DMS and that the instrument synchronizes the configuration, patient, user, and lot data. Check the settings of the following configuration items:
Result deletion algorithm Result retention period (in days) Result upload required before result deletion Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The database table capacity limit has been reached. Solution Contact your Roche Representative. Related L1 message G-AE u About level 1 messages and level 2 errors (209) Problem The database table capacity limit has been reached. Solution Contact your Roche representative. Related L1 message G-AE u About level 1 messages and level 2 errors (209) CA-0109: Database limit reached for linearity lot codes s e g a s s e m r o r r E 9 CA-0110: Database limit reached for QC lots Problem The database table capacity limit has been reached and no additional lots can be saved. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 267 CA-0111: Database limit reached for linearity lots Solution Delete all lots that are no longer needed from the instrument database (either directly on the instrument or via the DMS). Once an old lot is deleted, a new lot can be added to the instrument database. Related L1 message G-AE u About level 1 messages and level 2 errors (209) Problem The database table capacity limit has been reached and no additional lots can be saved. Solution Delete all lots that are no longer needed from the instrument database (either directly on the instrument or via the DMS). Once an old lot is deleted, a new lot can be added to the instrument database. Related L1 message G-AE u About level 1 messages and level 2 errors (209) CA-0113: Database limit reached for test strip lots Problem The database table capacity limit has been reached and no additional lots can be saved. Solution Delete all lots that are no longer needed from the instrument database (either directly on the instrument or via the DMS). Once an old lot is deleted, a new lot can be added to the instrument database. Related L1 message G-AE u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 268 Level 2 errors CA-0114: Password too long Problem The password entered is longer than the allowed 20 characters. Solution Enter a password which has the same or more characters than the configured minimal password length value, but not more than 20 characters. Related L1 message U-AB u About level 1 messages and level 2 errors (209) CA-0115: Invalid certificate configuration update Problem The DMS TLS certificate (DMS TLS certificate configuration item), which was updated via the DMS, is invalid. The instrument restored the previous certificate. Solution Ensure that the DMS TLS certificate (DMS TLS certificate configuration item) has the correct format. If a PFX file is used, the instrument configuration must contain the corresponding password in the DMS TLS certificate password configuration item. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0116: Different users log on as observer before and after OTS Problem A user who had not logged on as observer before the observed test sequence (OTS) tried to log on as observer after the test. The same observer must log in before and after the test. Solution Ensure that the same user is logged on as observer before and after the observed test sequence (OTS). s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 269 Related L1 message U-AD u About level 1 messages and level 2 errors (209) CA-0117: Invalid barcode content CA-0118: Invalid platform interface detected Problem During a shared workflow step, the user scanned a barcode with invalid content. Solution Ensure that the barcode scanned is valid, and that its content does not violate any validation rules. Related L1 message B-AA u About level 1 messages and level 2 errors (209) Problem The instrument detected an incompatibility between the Glucose app and an installed third-party app. Solution Ensure that the latest app software versions are installed on the instrument. Related L1 message G-AA u About level 1 messages and level 2 errors (209) CA-0119: Patient ID not found Problem The patient ID scanned is unknown to the instrument. Solution Ensure that the instrument is connected to the network. Check the connectivity and availability of the DMS using the Network status test option. Ensure that the DMS synchronizes the user list with the instrument. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 270 Level 2 errors Related L1 message U-AK u About level 1 messages and level 2 errors (209) CA-0120: Invalid test strip container barcode CA-0121: Linearity lot expired CA-0122: Test strip lot expired Problem The test strip container barcode scanned is invalid (e.g., incorrect format). Solution Ensure that you scan a strip container barcode intended for use with the cobas pulse instrument. Related L1 message B-AA u About level 1 messages and level 2 errors (209) Problem Linearity lot has expired. Solution Repeat the test using a valid (non-expired) linearity lot. Related L1 message D-AE u About level 1 messages and level 2 errors (209) Problem Test strip lot has expired. Solution Repeat the test using a valid (non-expired) test strip lot. Related L1 message D-AE u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 271 CA-0123: DMS host cannot be reached CA-0124: DMS server certificate check failed Problem The instrument was not able to connect to the DMS server socket. Solution Ensure that the instrument is connected to the network and the DMS server can be reached (and not blocked by a firewall). Check the connectivity and availability of the DMS using the Network status test option. Related L1 message I-AG u About level 1 messages and level 2 errors (209) Problem The instrument was not able to validate the TLS server certificate of the DMS. Solution Check the certificate stored in the DMS TLS certificate. If the configured certificate has expired, update the certificate and set the DMS TLS certificate check configuration item to Strict again. Check the connection between the instrument and the DMS using the Network status test option. Check your network infrastructure for breaches. Connect the instrument to a separate network and set the DMS TLS certificate check configuration item to
> Warning in order to allow a connection to the DMS. Related L1 message I-AE u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 272 Level 2 errors CA-0125: Instrument client certificate check failed Problem The DMS server was not able to validate the TLS client certificate of the instrument. Solution Ensure that the DMS server has the correct TLS certificate chain installed to be able to validate the instrument TLS (client) certificate. Ensure that the instrument and the DMS server have a valid current date and time. Check the connection between the instrument and the DMS using the Network status test option. Check your network infrastructure for breaches. Connect the instrument to a separate network and set the DMS TLS certificate check configuration item to
> Warning in order to allow a connection to the DMS. Related L1 message I-AE u About level 1 messages and level 2 errors (209) CA-0126: Generic DMS connection error Problem A generic DMS connection error occurred. Solution Ensure that the instrument is connected to the network and the DMS. Check the connectivity and availability of the DMS using the Network status test option. Related L1 message I-AG u About level 1 messages and level 2 errors (209) CA-0127: cobas infinity edge host cannot be reached Problem The instrument was not able to connect to the cobas infinity edge server socket. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 Error messages 273 Solution Ensure that the instrument is connected to the network and that the cobas infinity edge server can be reached
(and not blocked by a firewall). Check the connectivity and availability of the cobas infinity edge server using the Network status test option. Related L1 message u About level 1 messages and level 2 errors (209) CA-0128: cobas infinity edge server certificate check failed Problem The instrument was not able to validate the TLS server certificate of cobas infinity edge. Solution Ensure that the instrument and the cobas infinity edge server have a valid current date and time. Check the connection between the instrument and the cobas infinity edge server using the Network status test option. Check your network infrastructure for breaches. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) CA-0129: cobas infinity edge host name check failed Problem The instrument was not able to validate the host name specified in the TLS server certificate of cobas infinity edge. Solution Ensure that the actual host name/IP address of the cobas infinity edge server matches the host name/IP address which is specified in the TLS server certificate. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 274 Level 2 errors If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) CA-0130: Instrument client certificate check failed Problem The cobas infinity edge server was not able to validate the TLS client certificate of the instrument. Solution Ensure that the instrument and the cobas infinity edge server have a valid current date and time. Check the connection between the instrument and the cobas infinity edge server using the Network status test option. Check your network infrastructure for breaches. Ensure that the cobas infinity edge server has the correct TLS certificate chain installed to be able to validate the instrument TLS (client) certificate. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) CA-0131: cobas infinity edge workflow expired Problem A suspended cobas infinity edge workflow has exceeded the execution acknowledgment timeout. Solution Check the connection between the instrument and the cobas infinity edge server using the Network status test option. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 275 Related L1 message I-AH u About level 1 messages and level 2 errors (209) CA-0132: cobas infinity edge execution timeout CA-0133: Negative cobas infinity edge command acknowledgment received Problem An acknowledgement was received which exceeds the execution acknowledgment timeout. Solution Check the connection between the instrument and the cobas infinity edge server using the Network status test option. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) Problem A command acknowledgement with negative outcome code was received from cobas infinity edge. Solution Check the connection between the instrument and the cobas infinity edge server using the Network status test option. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) CA-0134: Service data upload failed Problem An error occurred while uploading service data to cobas infinity edge. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 276 Level 2 errors CA-0135: Service log data upload failed Solution Check the connection between the instrument and the cobas infinity edge server using the Network status test option. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) Problem An error occurred while uploading service log data to cobas infinity edge. Solution Check the connection between the instrument and the cobas infinity edge server using the Network status test option. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) CA-0136: Pseudonymization error s e g a s s e m r o r r E 9 Problem An error occurred during data pseudonymzation for data upload to cobas infinity edge. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message I-AH u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 277 CA-0137: Generic cobas infinity edge connection error CA-0138: Measuring range configuration error Problem A generic cobas infinity edge connection error occurred. Solution Ensure that the instrument is connected to the network and to cobas infinity edge. Check the connectivity and availability of the cobas infinity edge using the Network status test option. Related L1 message I-AH u About level 1 messages and level 2 errors (209) Problem The measuring range limits configured are inconsistent and do not comply to the following rule:
Reportable range lower limit Critical range lower limit Normal range lower limit Normal range higher limit Critical range higher limit Reportable range higher limit. Solution Ensure that the instrument configuration is updated with a configuration which complies with the stated rule (via the DMS or using the Configuration by barcode option). Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS In this section MS-0002: Measuring unit error(278) MS-0003: Measuring unit error(278) MS-0004: Measuring unit error(279) MS-0005: Measuring unit error(279) MS-0006: Measuring unit error(279) MS-0007: Measuring unit error(280) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 278 Level 2 errors MS-0015: Forced measuring unit shutdown(281) MS-0008: SW update error(280) MS-0010: Measuring unit error(280) MS-0011: Measuring unit error(280) MS-0012: Measuring unit error(281) MS-0013: SW update error(281) MS-0016: Measuring unit error(282) MS-0017: Measuring unit error(282) MS-0018: Measuring unit error(282) MS-0019: SW update error(282) MS-0020: Test strip ejection error(283) MS-0021: Measuring unit error(283) MS-0022: SW update error(283) MS-0023: Measuring unit error(284) MS-0024: Measuring unit error(284) MS-0025: Measuring unit error(284) MS-0026: Measuring unit error(284) MS-0027: Measuring unit error(285) MS-0028: Strip insertion period timed out(285) MS-0029: Dosing period timed out(285) MS-0030: Unexpected system shutdown(286) MS-0032: Measuring unit error(286) MS-0033: Test strip inserted during shutdown(286) MS-0034: Measuring unit configuration error(286) s e g a s s e m r o r r E 9 MS-0002: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0003: Measuring unit error Problem A measuring unit error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 279 MS-0004: Measuring unit error MS-0005: Measuring unit error Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0006: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 280 Level 2 errors MS-0007: Measuring unit error MS-0008: SW update error MS-0010: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem Software update was not completed successfully. Solution Trigger the software update process again via cobas infinity edge. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MS-0011: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 281 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0012: Measuring unit error MS-0013: SW update error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem Software update was not completed successfully. Solution Trigger the software update process again via cobas infinity edge. Related L1 message I-AC u About level 1 messages and level 2 errors (209) MS-0015: Forced measuring unit shutdown Problem Measuring unit was not shut down properly. Solution The instrument can be used without any restrictions. If the problem occurs on a regular basis, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 282 Level 2 errors MS-0016: Measuring unit error MS-0017: Measuring unit error MS-0018: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0019: SW update error s e g a s s e m r o r r E 9 Problem Software update was not completed successfully. Solution Trigger the software update process again via cobas infinity edge. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 283 Related L1 message I-AC u About level 1 messages and level 2 errors (209) MS-0020: Test strip ejection error MS-0021: Measuring unit error Problem The measuring unit failed to eject the test strip. Solution Eject the test strip using the eject button. If the problems persists, remove the test strip manually. Related L1 message H-AG u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0022: SW update error Problem Software update was not completed successfully. Solution Trigger the software update process again via cobas infinity edge. Related L1 message I-AC u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 284 Level 2 errors MS-0023: Measuring unit error MS-0024: Measuring unit error MS-0025: Measuring unit error Problem The measuring unit detected an error during measurement. Solution Repeat the test with a new test strip. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MS-0026: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 285 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0027: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0028: Strip insertion period timed out Problem The user did not insert the test strip within the permitted time period. Solution Repeat the test with a new test strip and apply sufficient sample when requested. Related L1 message D-AA u About level 1 messages and level 2 errors (209) MS-0029: Dosing period timed out Problem The user did not apply the sample (blood or QC/Linearity material) to the test strip within the permitted time period. Solution Repeat the test with a new test strip and apply sufficient sample when requested. Related L1 message S-AB u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 286 Level 2 errors MS-0030: Unexpected system shutdown MS-0032: Measuring unit error Problem A measuring unit error occurred. Solution The instrument can be used without any restrictions. If the problem occurs on a regular basis, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The user initiated a shutdown although the measuring unit still indicated that a test strip is inserted. Solution Eject the test strip before shutting down the instrument. Related L1 message G-AC u About level 1 messages and level 2 errors (209) MS-0033: Test strip inserted during shutdown s e g a s s e m r o r r E 9 MS-0034: Measuring unit configuration error Problem A measuring unit configuration error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 287 Solution Trigger a software update process again via cobas infinity edge. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU In this section MU-0090: Measuring unit error(291) MU-0091: Measuring unit error(292) MU-0092: Measuring unit error(292) MU-0094: Measuring unit error(292) MU-0095: Measuring unit error(293) MU-0096: Measuring unit error(293) MU-0097: Measuring unit error(293) MU-0098: Measuring unit error(294) MU-0120: Measuring unit error(294) MU-0130: Measuring unit error(294) MU-0131: Measuring unit error(295) MU-0132: Measuring unit error(295) MU-0133: Measuring unit error(295) MU-0134: Measuring unit error(296) MU-0135: Measuring unit error(296) MU-0136: Measuring unit error(296) MU-0137: Measuring unit error(297) MU-0138: Measuring unit error(297) MU-0139: Measuring unit error(297) MU-0140: Measuring unit error(298) MU-0141: Measuring unit error(298) MU-0142: Measuring unit error(298) MU-0143: Measuring unit error(299) MU-0145: Measuring unit error(299) MU-0146: Measuring unit error(299) MU-0147: Measuring unit error(299) MU-0148: Measuring unit error(300) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 288 Level 2 errors MU-0149: Measuring unit error(300) MU-0150: Measuring unit error(300) MU-0151: Measuring unit error(301) MU-0152: Measuring unit error(301) MU-0153: Measuring unit error(301) MS-0156: Temperature too low(301) MU-0157: Temperature too high(302) MU-0158: Measuring unit error(302) MU-0159: Measuring unit error(302) MU-0160: Measuring unit error(303) MU-0161: Measuring unit error(303) MU-0162: Measuring unit error(303) MU-0163: Measuring unit error(304) MU-0165: Measuring unit error(304) MU-0167: Measuring unit error(304) MU-0168: Measuring unit error(305) MU-0169: Measuring unit error(305) MU-0170: Measuring unit error(305) MU-0171: Measuring unit error(306) MU-0172: Measuring unit error(306) MU-0173: Ambient temperature error(306) MU-0174: Measuring unit error(307) MU-0175: Test strip mediator degradation fail-safe activated(307) MU-0176: Reused test strip fail-safe activated(307) MU-0178: Ascorbic-acid fail-safe activated(308) MU-0179: Voltage measurement fail-safe activated(308) MU-0180: Measuring unit error(308) MU-0182: Measuring unit error(309) MU-0183: Measuring unit error(309) MU-0231: Test strip ejection error(309) MU-0232: Test strip ejection error(310) MU-0241: Test strip ejection error(310) MU-0242: Measuring unit error(310) MU-0243: Measuring unit error(311) MU-0245: Measuring unit error(311) MU-0246: Measuring unit error(311) MU-0247: Measuring unit error(311) MU-0249: Measuring unit error(312) MU-0250: Measuring unit error(312) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 289 MU-0251: Measuring unit error(312) MU-0252: Measuring unit error(313) MU-0253: Measuring unit error(313) MU-0254: Measuring unit error(313) MU-0256: Measuring unit error(314) MU-0257: Measuring unit error(314) MU-0258: Measuring unit error(314) MU-0259: Measuring unit error(314) MU-0260: Measuring unit error(315) MU-0261: Measuring unit error(315) MU-0262: Measuring unit error(315) MU-0263: Measuring unit error(316) MU-0267: Measuring unit error(316) MU-0273: Measuring unit error(316) MU-0320: Measuring unit error(317) MU-0321: Measuring unit error(317) MU-0323: Measuring unit error(317) MU-0324: Measuring unit error(318) MU-0325: Measuring unit error(318) MU-0326: Measuring unit error(318) MU-0327: Measuring unit error(318) MU-0328: Measuring unit error(319) MU-0329: Measuring unit error(319) MU-0340: Measuring unit error(319) MU-0341: Test strip ID decoding error(320) MU-0342: Test strip ID decoding error(320) MU-0343: Test strip insertion error(320) MU-0345: Test strip inserted upside down(321) MU-0346: Measuring unit error(321) MU-0347: Measuring unit error(321) MU-0348: Measuring unit error(322) MU-0350: Measuring unit error(322) MU-0351: Measuring unit error(322) MU-0401: Measuring unit error(322) MU-0402: Measuring unit error(323) MU-0403: Measuring unit error(323) MU-0405: Measuring unit error(323) MU-0406: Measuring unit error(324) MU-0407: Measuring unit error(324) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 290 Level 2 errors MU-0409: Measuring unit error(324) MU-0410: Measuring unit error(325) MU-0412: Measuring unit error(325) MU-0413: Measuring unit error(325) MU-0416: Measuring unit error(326) MU-0419: Measuring unit error(326) MU-0420: Measuring unit error(326) MU-0421: Measuring unit error(327) MU-0423: Measuring unit error(327) MU-0424: Measuring unit error(327) MU-0425: Measuring unit error(328) MU-0426: Measuring unit error(328) MU-0427: Measuring unit error(328) MU-0428: Measuring unit error(329) MU-0429: Measuring unit error(329) MU-0430: Measuring unit error(329) MU-0431: Measuring unit error(330) MU-0432: Measuring unit error(330) MU-0501: Measuring unit error(330) MU-0502: Measuring unit error(331) MU-0503: Measuring unit error(331) MU-0505: Measuring unit error(331) MU-0506: Measuring unit error(332) MU-0512: Measuring unit error(332) MU-0513: Measuring unit error(332) MU-0514: Measuring unit error(333) MU-0515: Measuring unit error(333) MU-0521: Measuring unit error(333) MU-0523: Measuring unit error(334) MU-0524: Measuring unit error(334) MU-0525: Measuring unit error(334) MU-0526: Measuring unit error(335) MU-0527: Measuring unit error(335) MU-0528: Measuring unit error(335) MU-0529: Measuring unit error(336) MU-0541: Measuring unit error(336) s e g a s s e m r o r r E 9 MU-0560: Measuring unit fail-safe activated(336) MU-0561: Measuring unit fail-safe activated(337) MU-0562: Measuring unit fail-safe activated(337) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 291 MU-0563: Measuring unit fail-safe activated(337) MU-0564: Test strip fail-safe activated(338) MU-0567: Measuring unit fail-safe activated(338) MU-0901: Measuring unit error(338) MU-0905: Test strip contact error(339) MU-0906: Test strip contact error(339) MU-0910: Measuring unit error(339) MU-0930: Sample application error(340) MU-0940: Sample application error(340) MU-0941: Sample application error(340) MU-0945: Sample application error(341) MU-0947: Sample application error(341) MU-0951: Sample application error(341) MU-0952: Sample application error(342) MU-0960: Test strip error(342) MU-0961: Test strip error(342) MU-0962: Test strip error(343) MU-0963: Test strip error(343) MU-0971: Signal range violation(343) MU-0972: Signal range violation(344) MU-0973: Signal range violation(344) MU-0974: Signal range violation(344) MU-0975: Signal range violation(345) MU-0976: Signal range violation(345) MU-0978: Signal range violation(345) MU-0980: Signal range violation(346) MU-0981: Signal range violation(346) MU-0982: Signal range violation(347) MU-0983: Signal range violation(347) MU-0984: Signal range violation(347) MU-0987: Test strip insertion error(348) MU-0979: Removal of test strip during test(346) MU-0090: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 292 Level 2 errors MU-0091: Measuring unit error MU-0092: Measuring unit error If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0094: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 293 MU-0095: Measuring unit error MU-0096: Measuring unit error If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0097: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 294 Level 2 errors MU-0098: Measuring unit error MU-0120: Measuring unit error If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0130: Measuring unit error s e g a s s e m r o r r E 9 Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 295 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0131: Measuring unit error MU-0132: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0133: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 296 Level 2 errors Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0134: Measuring unit error MU-0135: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0136: Measuring unit error s e g a s s e m r o r r E 9 Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 297 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0137: Measuring unit error MU-0138: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0139: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 298 Level 2 errors MU-0140: Measuring unit error MU-0141: Measuring unit error MU-0142: Measuring unit error Problem A measuring unit error occurred. Solution Trigger a software update via cobas infinity edge. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Trigger a software update via cobas infinity edge. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Trigger a software update via cobas infinity edge. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 299 MU-0143: Measuring unit error Problem A measuring unit error occurred. Solution Trigger a software update via cobas infinity edge. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Trigger a software update via cobas infinity edge. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0145: Measuring unit error MU-0146: Measuring unit error MU-0147: Measuring unit error Problem A measuring unit error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 300 Level 2 errors MU-0148: Measuring unit error MU-0149: Measuring unit error Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0150: Measuring unit error s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 301 MU-0151: Measuring unit error MU-0152: Measuring unit error MU-0153: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MS-0156: Temperature too low Problem The instrument has detected that the instrument temperature is too low for testing and has activated the temperature lockout. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 302 Level 2 errors MU-0157: Temperature too high MU-0158: Measuring unit error Solution Use the instrument at a higher temperature. The temperature lockout will be deactivated as soon as the instrument detects a supported instrument temperature. Related L1 message E-AA u About level 1 messages and level 2 errors (209) Problem The instrument has detected that the instrument temperature is too high for testing and has activated the temperature lockout. Solution Use the instrument at a lower temperature. The temperature lockout will be deactivated as soon as the instrument detects a supported instrument temperature. Related L1 message E-AB u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Repeat the test with a new test strip. If the problem persists, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0159: Measuring unit error Problem A measuring unit error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 303 MU-0160: Measuring unit error MU-0161: Measuring unit error Solution The instrument can be used without any restrictions.If the problem occurs on a regular basis, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0162: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 304 Level 2 errors MU-0163: Measuring unit error MU-0165: Measuring unit error If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0167: Measuring unit error s e g a s s e m r o r r E 9 Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 305 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0168: Measuring unit error MU-0169: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0170: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 306 Level 2 errors Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0171: Measuring unit error MU-0172: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message D-AH u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0173: Ambient temperature error Problem The instrument has detected that the ambient temperature is outside of the specified limits and has activated the temperature lockout. Solution Use the instrument at the specified temperature. The temperature lockout will be deactivated as soon as the instrument detects a supported ambient temperature. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 307 Related L1 message E-AB u About level 1 messages and level 2 errors (209) MU-0174: Measuring unit error MU-0175: Test strip mediator degradation fail-safe activated Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a test strip which seems to have been exposed to humidity stress. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations.If this problem persists, use a new test strip from a different test strip container. Related L1 message D-AF u About level 1 messages and level 2 errors (209) MU-0176: Reused test strip fail-safe activated Problem The measuring unit detected a test strip which seems to have already been used. Solution Repeat the test with a strip from another container. If this does not solve the issue, repeat the test with another strip and another instrument. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 308 Level 2 errors Related L1 message D-AF u About level 1 messages and level 2 errors (209) MU-0178: Ascorbic-acid fail-safe activated Problem The measuring unit detected high ascorbic-acid concentration in the sample. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations. If this problem persists while testing other patients, contact your Roche representative. Related L1 message S-AF u About level 1 messages and level 2 errors (209) Problem The measuring unit detected an error during the voltage measurement. The test failed. Solution Repeat the test with a new test strip. If this problem persists, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) MU-0179: Voltage measurement fail-safe activated MU-0180: Measuring unit error s e g a s s e m r o r r E 9 Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 309 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0182: Measuring unit error MU-0183: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G_AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0231: Test strip ejection error Problem An error with the strip ejection mechanism occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 310 Level 2 errors Related L1 message H-AG u About level 1 messages and level 2 errors (209) MU-0232: Test strip ejection error MU-0241: Test strip ejection error Problem An error with the strip ejection mechanism occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem An error with the strip ejection mechanism occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0242: Measuring unit error s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 311 MU-0243: Measuring unit error MU-0245: Measuring unit error MU-0246: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0247: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 312 Level 2 errors Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0249: Measuring unit error MU-0250: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0251: Measuring unit error s e g a s s e m r o r r E 9 Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 313 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0252: Measuring unit error MU-0253: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0254: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 314 Level 2 errors Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0256: Measuring unit error MU-0257: Measuring unit error MU-0258: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0259: Measuring unit error Problem A measuring unit error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 Error messages 315 MU-0260: Measuring unit error MU-0261: Measuring unit error Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0262: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 316 Level 2 errors Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0263: Measuring unit error MU-0267: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0273: Measuring unit error s e g a s s e m r o r r E 9 Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 317 Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0320: Measuring unit error MU-0321: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0323: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 318 Level 2 errors Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0324: Measuring unit error MU-0325: Measuring unit error MU-0326: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0327: Measuring unit error Problem A measuring unit error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 Error messages 319 MU-0328: Measuring unit error MU-0329: Measuring unit error Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0340: Measuring unit error Problem A measuring unit error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 320 Level 2 errors MU-0341: Test strip ID decoding error MU-0342: Test strip ID decoding error Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem The instrument could not read the test strip ID (e.g. due to dirt or scratches). Solution Eject the test strip and insert a new test strip. If the problem persists, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) Problem The instrument could not read the test strip ID (e.g. due to dirt or scratches). Solution Eject the test strip and insert a new test strip. If the problem persists, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0343: Test strip insertion error Problem The measuring unit detected that a test strip was not fully inserted or inserted upside down. Solution Eject the test strip and insert it correctly. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 321 Related L1 message D-AG u About level 1 messages and level 2 errors (209) MU-0345: Test strip inserted upside down MU-0346: Measuring unit error Problem The measuring unit detected that the test strip was inserted upside down. Solution Eject the test strip and insert it correctly. Related L1 message D-AG u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0347: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 322 Level 2 errors MU-0348: Measuring unit error MU-0350: Measuring unit error MU-0351: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0401: Measuring unit error Problem A measuring unit error occurred. Solution Contact your Roche representative. Related L1 message G-AA Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 323 u About level 1 messages and level 2 errors (209) MU-0402: Measuring unit error MU-0403: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0405: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 324 Level 2 errors MU-0406: Measuring unit error MU-0407: Measuring unit error MU-0409: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 325 MU-0410: Measuring unit error MU-0412: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0413: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 326 Level 2 errors MU-0416: Measuring unit error MU-0419: Measuring unit error MU-0420: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 327 MU-0421: Measuring unit error MU-0423: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0424: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 328 Level 2 errors MU-0425: Measuring unit error MU-0426: Measuring unit error MU-0427: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 329 MU-0428: Measuring unit error MU-0429: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0430: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 330 Level 2 errors MU-0431: Measuring unit error MU-0432: Measuring unit error MU-0501: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 331 MU-0502: Measuring unit error MU-0503: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0505: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 332 Level 2 errors MU-0506: Measuring unit error MU-0512: Measuring unit error MU-0513: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 333 MU-0514: Measuring unit error MU-0515: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0521: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 334 Level 2 errors MU-0523: Measuring unit error MU-0524: Measuring unit error MU-0525: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 335 MU-0526: Measuring unit error MU-0527: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0528: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 336 Level 2 errors MU-0529: Measuring unit error MU-0541: Measuring unit error Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0560: Measuring unit fail-safe activated Problem The measuring unit detected a sample which triggered a fail-safe logic. The test failed. Solution Repeat the test with a new test strip. If this problem persists, contact your Roche representative. Related L1 message S-AF u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 337 MU-0561: Measuring unit fail-safe activated MU-0562: Measuring unit fail-safe activated MU-0563: Measuring unit fail-safe activated Problem The measuring unit triggered a fail-safe logic for the applied sample. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations. Related L1 message S-AF u About level 1 messages and level 2 errors (209) Problem The measuring unit triggered a fail-safe logic for the applied sample. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations. Related L1 message S-AF u About level 1 messages and level 2 errors (209) Problem The measuring unit triggered a fail-safe logic for the applied sample. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations. Related L1 message S-AF u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 338 Level 2 errors MU-0564: Test strip fail-safe activated MU-0567: Measuring unit fail-safe activated Problem The measuring unit triggered a fail-safe related to external environmental conditions for the inserted test strip. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations. Related L1 message D-AF u About level 1 messages and level 2 errors (209) Problem The measuring unit triggered a fail-safe logic for the applied sample. The test failed. Solution Repeat the test with a new test strip. Follow proper usage in the handling recommendations. Related L1 message S-AF u About level 1 messages and level 2 errors (209) Problem A measuring unit error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) MU-0901: Measuring unit error s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 339 MU-0905: Test strip contact error MU-0906: Test strip contact error Problem A test strip contact error occurred. Solution Repeat the test with a new test strip. If this problem persists, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) Problem A test strip contact error occurred. Solution Repeat the test with a new test strip. If this problem persists, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) MU-0910: Measuring unit error Problem The measuring unit detected an error in the isolation resistance measurement which resulted in a failed test. Solution Repeat the test with a new test strip. Do not apply sample too early. Do not re-use a test strip. If the problem persists, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 340 Level 2 errors MU-0930: Sample application error MU-0940: Sample application error Problem The sample was applied to early. Solution Repeat the test with a new test strip.Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) Problem The instrument could not detect a sample application within the given timeout. Solution Repeat the test with a new test strip.Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) Problem The instrument detected an unsteady sample application or insufficient sample volume was applied. Solution Repeat the test with a new test strip. Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) MU-0941: Sample application error s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 341 MU-0945: Sample application error MU-0947: Sample application error Problem The instrument detected an unsteady sample application, or the test strip was moved during sample application or sample detection. Solution Repeat the test with a new test strip. Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) Problem The instrument detected an unsteady sample application, or the test strip was moved during sample application or sample detection. Solution Repeat the test with a new test strip. Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) MU-0951: Sample application error Problem The instrument detected an unsteady sample application, or the test strip was moved during sample application or sample detection. Solution Repeat the test with a new test strip. s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 342 Level 2 errors MU-0952: Sample application error Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) Problem The instrument detected an unsteady sample application, or the test strip was moved during sample application or sample detection. Solution Repeat the test with a new test strip. Apply sufficient sample when requested without moving the test strip. If this problem persists, contact your Roche representative. Related L1 message S-AB u About level 1 messages and level 2 errors (209) Problem A test strip error occurred. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message D-AA u About level 1 messages and level 2 errors (209) MU-0960: Test strip error s e g a s s e m r o r r E 9 MU-0961: Test strip error Problem A test strip error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 343 MU-0962: Test strip error MU-0963: Test strip error Solution Repeat the test with a strip from another container. If this does not solve the issue, repeat the test with another strip and another instrument. Related L1 message D-AF u About level 1 messages and level 2 errors (209) Problem A test strip error occurred. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message D-AF u About level 1 messages and level 2 errors (209) Problem A test strip error occurred. Solution Repeat the test with a strip from another container. If this does not solve the issue, repeat the test with another strip and another instrument. Related L1 message D-AF u About level 1 messages and level 2 errors (209) MU-0971: Signal range violation Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 344 Level 2 errors MU-0972: Signal range violation MU-0973: Signal range violation If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0974: Signal range violation Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 345 MU-0975: Signal range violation MU-0976: Signal range violation If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) MU-0978: Signal range violation Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 346 Level 2 errors If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) MU-0979: Removal of test strip during test MU-0980: Signal range violation Problem The measuring unit detected a signal range violation. Solution The test strip was removed during the test. Repeat the test with a new test strip. Do not remove test strip during processing. Related L1 message D-AL u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 MU-0981: Signal range violation Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 347 MU-0982: Signal range violation MU-0983: Signal range violation If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) MU-0984: Signal range violation Problem The measuring unit detected a signal range violation. Solution Repeat the test with a new test strip. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 348 Level 2 errors MU-0987: Test strip insertion error If this problem persists while testing other patients, contact your Roche representative. Related L1 message G-AC u About level 1 messages and level 2 errors (209) Problem The test strip was inserted too early. Solution Eject the test strip and insert it again when requested. Related L1 message D-AK u About level 1 messages and level 2 errors (209) US s e g a s s e m r o r r E 9 In this section US-0001: Unknown error(349) US-0002: Software update package retrieval failed(349) US-0003: Invalid software update package(350) US-0004: Measuring unit firmware update error(350) US-0005: Measuring unit firmware update error(350) US-0007: SW update error(351) US-0008: Error during shutdown(351) US-0009: SW update error(351) US-0010: Measuring unit error(352) US-0011: Measuring unit error(352) US-0012: High-level measuring unit firmware update failed(352) US-0013: Software update failed(353) US-0014: App update failed(353) US-0016: Measuring unit software update error(353) US-0017: Measuring unit software update error(354) US-0018: Software update failed(354) US-0019: Operating system update failed(354) US-0020: Component compatibility check failed(355) US-0021: App uninstall failed(355) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 349 US-0022: Software update already in process(355) US-0023: Software update package download failed(356) US-0024: Software update error(356) US-0025: Software update error(356) US-0026: Software update error(357) US-0027: Software update error(357) US-0028: Incompatible software update container(358) US-0001: Unknown error US-0002: Software update package retrieval failed Problem An unknown error occurred. Solution Restart the instrument and try again. If the problem persists, contact your Roche representative. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem One or multiple parts of the software update package could not be retrieved because the connection to cobas infinity edge was interrupted. Solution Ensure that the instrument is connected to the Wi-Fi. Check the connection between the instrument and cobas infinity edge using the Network status test option. Related L1 message I-AH u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 350 Level 2 errors US-0003: Invalid software update package US-0004: Measuring unit firmware update error Problem The meta-data of the software update package is invalid
(e.g., malformed or incomplete). Solution Contact your Roche representative. Related L1 message I-AF u About level 1 messages and level 2 errors (209) Problem The measuring unit firmware update could not be started. Solution Restart the instrument. Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the firmware update via cobas infinity edge. Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0005: Measuring unit firmware update error s e g a s s e m r o r r E 9 Problem The measuring unit firmware update could not be started. Solution Restart the instrument. Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the firmware update via cobas infinity edge. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 351 Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0007: SW update error US-0008: Error during shutdown Problem A software update error occurred. Solution Contact your Roche representative. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem The instrument could not shut down the operating system as part of the software update process. Solution Restart the instrument and check the instrument software configuration in the GUI. Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0009: SW update error Problem A software update error occurred. Instrument cannot be used. Solution Contact your Roche representative. Related L1 message I-AC u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 352 Level 2 errors US-0010: Measuring unit error US-0011: Measuring unit error Problem A measuring unit software update error occurred. Solution Restart the instrument. Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the software update via cobas infinity edge. Related L1 message G-AA u About level 1 messages and level 2 errors (209) Problem A measuring unit software update error occurred. Solution Restart the instrument. Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the software update via cobas infinity edge. Related L1 message G-AA u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 US-0012: High-level measuring unit firmware update failed Problem The measuring unit firmware update could not be completed via the intended high-level software interface. Solution No further action required since the update was performed using a low-level software interface. Related L1 message I-AC Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 353 u About level 1 messages and level 2 errors (209) US-0013: Software update failed Problem An error occurred during a planned restart of the instrument during a software update. The software update failed. Solution Restart the instrument. Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the software update via cobas infinity edge. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem An app update failed. Solution Restart the instrument. Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the software update via cobas infinity edge. If the problem persists, contact your Roche representative. US-0014: App update failed Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0016: Measuring unit software update error Problem A measuring unit software update error occurred. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 s e g a s s e m r o r r E 9 354 Level 2 errors US-0017: Measuring unit software update error US-0018: Software update failed Solution Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the software update via cobas infinity edge. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem The low-level measuring unit firmware update failed. Solution Contact your Roche representative. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem The software update package was rejected by the instrument due to a signature verification error. Solution Contact your Roche representative. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem An operating system software update failed. Solution Ensure that the instrument is connected to the network using the Network status test option, and that the connection is stable. Restart the software update via cobas infinity edge. US-0019: Operating system update failed s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 355 Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0020: Component compatibility check failed Problem The software update package was rejected by the instrument because the compatibility check failed. Solution Check the available software update packages and ensure that a compatible software update package is available. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Problem The instrument was not able to uninstall an app. Solution Contact your Roche representative. Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0021: App uninstall failed US-0022: Software update already in process Problem The software update package was rejected by the instrument because another software update is already in process. Solution Wait until the current software update is finished and try again. Related L1 message I-AF u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 356 Level 2 errors US-0023: Software update package download failed US-0024: Software update error Problem One or multiple parts of the software update package could not be retrieved. The connection to cobas infinity edge was interrupted. Solution Ensure that the instrument is connected to the network. Check the connection between the instrument and cobas infinity edge using the Network status test option. Related L1 message I-AF u About level 1 messages and level 2 errors (209) Problem The software update package was rejected by the instrument. Solution Check the available software update packages and ensure that compatible software update package is available. Related L1 message I-AC u About level 1 messages and level 2 errors (209) US-0025: Software update error s e g a s s e m r o r r E 9 Problem The software update package was rejected by the instrument. Solution Check the available software update packages and ensure that compatible software update package is available. Related L1 message I-AC u About level 1 messages and level 2 errors (209) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Error messages 357 US-0026: Software update error US-0027: Software update error Problem The uninstall of an essential instrument app was prevented. Solution Check the available software update packages and ensure that a compatible instrument software update package is available.Turn off and restart the instrument. Ensure that the instrument is connected to the network using the Network status test option and that the connection is stable. Restart the software update via cobas infinity edge. Related L1 message I-AF u About level 1 messages and level 2 errors (209) Problem The instrument received a software update container with a 3rd-party app although it was expecting an instrument software update container. You are not allowed to execute anything other than instrument update containers. Solution Check the available software update packages and ensure that a compatible instrument software update package is available.Turn off and restart the instrument. Ensure that the instrument is connected to the network using the Network status test option and that the connection is stable. Restart the software update via cobas infinity edge. Related L1 message I-AF u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 358 Level 2 errors US-0028: Incompatible software update container Problem The instrument detected an incompatible software update container and consequently did not start the software update process. Solution Check the available software update packages and ensure that a compatible software update package is available. Related L1 message I-AF u About level 1 messages and level 2 errors (209) s e g a s s e m r o r r E 9 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Configuration 10 Initial configuration.....................................................................................361 11 General configuration................................................................................421 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 361 Initial configuration In this chapter About instrument configuration ....................................... About the Settings menu access restrictions.............. Setting the instrument date and time ............................ Configuring by barcode....................................................... Formats and language configuration ............................. Date format ................................................................... Time format ................................................................... Language and region ................................................ Regulatory region ....................................................... QC configuration.................................................................... QC algorithm ................................................................ QC algorithm ..................................................... QC interval (in hours)..................................... Shift length (in hours) .................................... Shift start............................................................. Test strip count................................................. Time of day......................................................... QC tests required for new test strip lots . Show numeric QC result value .............................. QC range handling ..................................................... Allowed deviation for QC level 1 result ... Allowed deviation for QC level 2 result ... Data deletion ........................................................................... Result deletion ............................................................. Result deletion algorithm.............................. Result retention period (in days) ............... Result upload required before result deletion ................................................................ Audit trail retention period (in days) ................... Barcode camera configuration ......................................... 10 365 367 368 370 371 371 372 372 374 376 376 376 378 378 379 380 380 381 382 382 382 383 385 385 385 386 386 387 388 n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 362 Table of contents Minimum barcode scanning time......................... 388 Checksum validation of barcode type
"Interleaved 2 of 5" ..................................................... Connectivity.............................................................................. Synchronization warning / lockout ...................... Show synchronization lockout warning prior to actual lockout (in hours)............... Synchronization lockout (in hours)........... DMS/cobas infinity edge connection retry timeout (in seconds).................................................. DMS session timeout (in seconds) ...................... DNS IPv4 address ....................................................... DNS IPv6 address ....................................................... Gateway IPv4 address ............................................... Gateway IPv6 address ............................................... Instrument IPv4 address........................................... Instrument IPv6 address........................................... IPv4 subnet mask........................................................ Network Time Protocol (NTP) ................................ NTP server address ................................................... Instrument time zone................................................. Data management system IP address / host name ................................................................................ Data management system port number ............ cobas infinity edge IP address / host name...... cobas infinity edge port number........................... Wi-Fi connection ......................................................... Wi-Fi SSID........................................................... Use DHCP ........................................................... Use domain name system (DNS)? ............ Anonymous User.............................................. CA Certificate .................................................... Client Certificate............................................... User Name.......................................................... Password............................................................. Client private key password......................... Client private key ............................................. EAP Type ............................................................. Wi-Fi security type........................................... Wi-Fi key type.................................................... Wi-Fi encryption key....................................... 388 390 390 390 391 392 392 393 393 394 395 395 396 397 397 398 399 400 401 401 402 403 404 404 405 406 406 407 407 408 408 408 409 410 410 411 n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 363 Wi-Fi password ................................................. Wi-Fi cryptographic algorithm type .......... List of Wi-Fi security configurations......... TLS security................................................................... DMS TLS certificate check........................... cobas infinity edge TLS certificate check .................................................................... DMS TLS level................................................... DMS TLS certificate ........................................ DMS TLS certificate password ................... cobas infinity edge TLS level....................... 411 412 412 414 414 415 416 417 418 418 n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 364 Table of contents Page intentionally left blank. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 About instrument configuration Initial configuration 365 You can perform a basic initial installation on the instrument manually, or by using a barcode. i For more detailed information, refer to the cobas pulse Connectivity guide. Depending on the systems to which the instrument is connected (DMS, cobas infinity edge), further configuration will be made by the corresponding systems. When you turn on the instrument for the first time you are prompted to select the language you require for the user interface. After selecting the language, you choose the appropriate installation option. An installation by barcode configures an instrument to be able to connect with the intended system with which the instrument will connect (DMS, cobas infinity edge ). If the instrument is connected to a DMS, it receives all additional configuration information from the DMS. This method is best suited when a large number of instruments must be configured. The configuration information must first be set using the configuration tool (cobas infinity edge). Tapping the Installation by barcode button displays the Scan barcode screen with which you scan the barcode containing the configuration information which enables the instrument to connect to the intended systems (DMS, cobas infinity edge). After scanning the barcode successfully, the instrument connects to the intended systems for further instrument configuration. n o i t a r u g i f n o c l a i t i n I 0 1 Installation by barcode Manual installation On the Manual installation screen you are prompted to do the following:
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 GlucoseLanguageManualinstallationInstallation bybarcodeInstallation by barcodeWi-Fi activatedAssociatedAuthenticatedReceived IP:Gateway:DNS:Contacted DMSConnected to DMSContacted cobas infinity edgeConnected to cobas infinity edge 366 About instrument configuration Choose the date format using the Date format option (for example, dd-MMM-yyyy), and enter the current date. Choose the time format using the Time format option (for example, 12 hour (am/pm)), and enter the current time. Choose the Test strip lot option, scan a barcode containing the test strip lot data. The barcode is generated in cobas infinity edge. It is not the barcode on the test strip container. The Glucose unit option displays the configured glucose unit (for example, mmol/L). Changing the glucose unit is only possible using a configuration barcode (generated in cobas infinity edge). Choose the glucose unit (for example, mmol/L) using the Glucose unit option. After you have made the appropriate settings, the Tests screen is displayed. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Manual installationDate formatDateTime formatTimeTest strip lotGlucose unitConfirm About the Settings menu access restrictions Initial configuration 367 The instrument can be configured to restrict access to certain options in the Settings menu. The following options enable restricted access configuration:
Date and time Configuration by barcode Lot management Administrator The instrument can be configured to access the options by one of the following methods. No restrictions Setup password required Access only via the DMS No access Point of Care Coordinator privilege required For security reasons, the setup password is set up in the barcode used in the initial instrument configuration
(cobas infinity edge). The table illustrates the different types of access that can apply to each option. d r o w s s a p p u t e S x x x x e g e l i v i r p C C O P x x x x n o i t c i r t s e r o N x x x x y l n o S M D a V i x s s e c c a o N x x x Set by the initial barcode /
DMS Setting the date and time Instrument configuration by barcode Lot management Administrator activities Setup password y Access restrictions n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 368 Setting the instrument date and time Setting the instrument date and time You use the date and time screens to set the instrument date and time. The date and time formats used by an instrument are determined by its configuration. j m You are logged onto the instrument u Logging on to the Glucose app (99) r To set the instrument date and time 1 Choose
> Date and time. I Depending on your instrument configuration, this option may be password protected. 2 To set the instrument date, on the Date and time screen tap the Set date option. f The date picker is displayed n o i t a r u g i f n o c l a i t i n I 0 1 3 To change the year, in the date picker do the Tap the current year. following:
Use the year picker to select a year. Tap the Confirm button. 4 To change the month and day, in the date picker do button or the the following:
Tap the month. For the selected month, tap the desired day. Tap the Confirm button. f The instrument date is set, and the Date and button to select a time screen is displayed. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Date and timeSet dateSet time19-Nov-202111:06 AMThu, Apr 182021April 2021ConfirmCancel Initial configuration 369 5 To set the instrument time, on the Date and time screen tap the Set time option. 6 To set the time use one of the following methods:
Time picker Type in time 7 To use the time picker, do the following:
Drag the clock hand to the desired hour. Drag the clock hand to the desired minutes. If the instrument uses the 12 hour clock format, tap AM or PM. Tap the Confirm button. f The new time is set. 8 To use type in time, do the following:
On the time picker screen tap the Use the keyboard to enter the new time. f The new time is set. Tap the Confirm button. button. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Date and timeSet dateSet time19-Nov-202111:06 AM3 :30AMPMConfirmCancel 370 Configuring by barcode Configuring by barcode You can configure an instrument by scanning a barcode. The Configuration by barcode option can be used to do the following:
Initial instrument configuration Subsequent instrument configuration After a subsequent configuration, the change takes effect the next time that you log onto the Glucose app c As required r To configure by barcode 1 Tap
> Configuration by barcode. 2 If prompted, enter the setup password to change the settings by barcode and tap the Confirm button. 3 Scan the barcode which can be generated in cobas infinity edge. f When the barcode has been scanned successfully the instrument emits a beep and a confirmation dialog box is displayed. 4 In the Configuration change dialog box, tap the Confirm button. f The Configuration changed dialog box confirms that the configuration has been made. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 371 Formats and language configuration Date format In this section Date format(371) Time format(372) Language and region(372) Regulatory region(374) This configuration item specifies the date format that is used on the instrument. When an instrument is started for the first time and a manual installation is performed, you are prompted to select the date format using the user interface. Thereafter you cannot change the date format using the user interface. i The format of the date on the status bar is determined by the Language and region configuration, not the Date format configuration. Item ID DATE_FORMAT Available values/format dd-MMM-yyyy (default)
[DATE_FORMAT_0]
MMM dd, yyyy
[DATE_FORMAT_1]
MM/dd/yyyy
[DATE_FORMAT_2]
dd.MM.yyyy
[DATE_FORMAT_3]
Configuration You configure the Date format configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) User interface (only during initial configuration) u Related topics About instrument configuration (365) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 372 Formats and language configuration Time format Item ID TIME_FORMAT Available values/format 12 hours (default)
[HOURS_12]
24 hours
[HOURS_24]
Configuration This configuration item specifies the time format that is used on the instrument. When an instrument is started for the first time and a manual installation is performed, you are prompted to select the time format using the user interface. Thereafter you cannot change of the time format using the user interface. i The format of the time on the status bar is determined by the Language and region configuration, not the Time format configuration. You configure the Time format configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) User interface (only during initial configuration) u Related topics About instrument configuration (365) This configuration item determines the language and region combination used on the instrument. It consists of a language tag and a region tag:
<language tag>-<region tag>
The language tag must be set according to the permitted values(2) listed in the table (e.g., en for English). The region tag must be set according to the list of permitted values. The Chinese language and region are handled as follows:
Language and region n o i t a r u g i f n o c l a i t i n I 0 1
(2) ISO 639-1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 373 zh-CN corresponds to simplified Chinese. zh-TW corresponds to traditional Chinese Item ID INSTRUMENT_LOCALE Available values/format The table contains valid combinations(3) of a language tag and region/country tag for the Language and region configuration item. Only one of the listed region/country tags can be combined with a given language tag (e.g., a valid configuration is "en-US") Language tag Region/country tag de fr es it nl da sv en no pt fi pl cs hu ja ko AT, BE, CH, DE, IT, LI, LU BE, BF, BI, BJ, BL, CA, CD, CF, CG, CH, CI, CM, DJ, DZ, FR, GA, GF, GN, GP, GQ, HT, KM, LU, MA, MC, MF, MG, ML, MQ, MR, MU, NC, NE, PF, PM, RE, RW, SC, SN, SY, TD, TG, TN, VU, WF, YT 419, AR, BO, BR, BZ, CL, CO, CR, CU, DO, EA, EC, ES, GQ, GT, HN, IC, MX, NI, PA, PE, PH, PR, PY, SV, US, UY, VE CH, IT, SM, VA AW, BE, BQ, CW, NL, SR, SX DA, GL AX, FI, SE 001, 150, AG, AI, AS, AT, AU, BB, BE, BI, BM, BS, BW, BZ, CA, CC, CH, CK, CM, CX, CY, DE, DG, DK, DM, ER, FI, FJ, FK, FM, GB, GD, GG, GH, GI, GM, GU, GY, HK, IE, IL, IM, IN, IO, JE, JM, KE, KI, KN, KY, LC, LR, LS, MG, MH, MO, MP, MS, MT, MU, MW, MY, NA, NF, NG, NL, NR, NU, NZ, PG, PH, PK, PN, PR, PW, RW, SB, SC, SD, SE, SG, SH, SI, SL, SS, SX, SZ, TC, TK, TO, TT, TV, TZ, UG, UM, US, US, VC, VG, VI, VU, WS, XA, ZA, ZM, ZW AO, BR, CH, CV, GQ, GW, LU, MO, MZ, PT, ST, TL NO FI PL CZ HU JP KP, KR y Valid <language tag> and <region/country tag>
combinations n o i t a r u g i f n o c l a i t i n I 0 1
(3) ISO3166-1 alpha-2 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 374 Formats and language configuration Language tag Region/country tag BY, KG, KZ, MD, RU, UA TH IL CY, GR CY, TR th ru he el tr zh CN (for simplified Chinese), TW (for traditional Chinese) y Valid <language tag> and <region/country tag>
combinations Default value: en-US Configuration You configure the Language and region configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) User interface (during the initial configuration only the language is set) Regulatory region This configuration item determines the country in which an instrument is used. The instrument adjusts the WLAN parameters used according to the country configured and applies additional dependencies. Item ID REGULATORY_REGION Available values/format
(ISO 3166-1 codes alpha-2) Dependencies When the Regulatory region value is set to Canada, the Result unit (glucose tests) value can only be set to mmol/L. It is not possible to change it to mg/dL. When the Regulatory region value is set to United States of America, the following actions are applied:
The User authentication required configuration item value is set to Enabled and cannot be changed. A user ID which does not contain a value in the Show user lockout warning prior to user certificate expiration configuration item is invalid and rejected by the instrument. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 375 The QC algorithm configuration item value is set to Time interval and changing it to Disabled is prevented. It is possible to change the QC algorithm configuration item to any other value than Disabled. The Allow QC / synchronization lockout overrides configuration item value is set to Disabled and cannot be changed. Configuration You configure the Regulatory region configuration item using the following:
Barcode (generated via cobas infinity edge) u Related topics Result unit (glucose tests) (460) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 376 QC configuration QC configuration QC algorithm In this section QC algorithm(376) Show numeric QC result value(382) QC range handling(382) In this section QC algorithm(376) QC interval (in hours)(378) Shift length (in hours)(378) Shift start(379) Test strip count(380) Time of day(380) QC tests required for new test strip lots(381)
[ALWAYS_OK]
QC lockout is disabled. Time interval
[HOURS]
QC lockout is enabled after a specified number of hours since the last successful QC test. was performed. It works in conjunction with the QC interval (in hours) configuration item. Time interval (alternating QC level)
[HOURS_ROTATE]
The same as Time interval, but the QC test uses the level 1 and the level 2 QC materials alternately rather than both levels. Until failed QC (Default)
[LAST_QC_OK]
QC algorithm This configuration item specifies how QC lockout is enabled on the instrument. Item ID QC_ALGORITHM Available values/format Disabled n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 377 QC lockout is enabled when the last QC test performed is out of range. Consequently if no successful QC test has been performed, the instrument will be in QC lockout. Shift
[SHIFT]
A QC lockout is activated with each change of shift. It works in conjunction with the Shift length (in hours) and Shift start configuration items. Shift (alternating QC level)
[SHIFT_ROTATE]
The same as Shift, but the QC test uses the level 1 and the level 2 QC materials alternately rather than both levels. Test strip count
[STRIP_COUNT]
QC lockout is enabled after a predetermined number of successful tests have been performed (excluding QC tests). It works in conjunction with the Test strip count configuration item. Test strip count (alternating QC level)
[STRIP_COUNT_ROTATE]
The same as Test strip count, but the QC test uses level 1 and level 2 QC materials alternately rather than both levels. Time of day
[TIME_OF_DAY]
QC lockouts are enabled at specified times of day (up to 6). It works in conjunction with the Time of day configuration item. Time of day (alternating QC level)
[TIME_OF_DAY_ROTATE]
The same as Time of day, but the QC uses L1 and L2 controls alternately rather than both controls. Dependencies If Country = "US", the value of QC algorithm cannot be set to Disabled. Configuration You configure the QC algorithm configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics QC interval (in hours) (378) Shift length (in hours) (378) Shift start (379) Test strip count (380) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 378 QC configuration Time of day (380) QC interval (in hours) This configuration item specifies the time period (hours) for which a positive QC result is valid. A QC lockout is enabled after this period is exceeded. QC interval (in hours) works in conjunction with the QC algorithm configuration item. Item ID QC_HOURS Available values/format 1-9999 hours (default: 1000 hours). Values must be integers. Dependencies Configuring QC interval (in hours) is only necessary when the QC algorithm configuration item value is Time interval or Time interval (alternating QC level). Configuration You configure QC interval (in hours) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics QC algorithm (376) This configuration item specifies the length of a working shift in hours. This is required when a QC lockout is based on the changeover of a working shift. Shift length (in hours) works in conjunction with the Shift start configuration item. Item ID QC_SHIFT_LENGTH Available values/format The value must be an even divisor of 24:
1, 2, 3, 4, 6, 8 (default), 12, 24 hours. Values must be integers. Shift length (in hours) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Shift start Initial configuration 379 Dependencies Configuring Shift length (in hours) is only necessary when the QC algorithm configuration item value is Shift or Shift (alternating QC level). Configuration You configure the Shift length (in hours) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics QC algorithm (376) Shift start (379) This configuration item specifies the start time of a shift. This is required when a QC lockout is based on the changeover of a working shift. Shift start works in conjunction with the Shift length
(in hours) configuration item. Item ID QC_SHIFT_START Available values/format 0 - 23 hours (default: 6 hours) Values must be integers. Dependencies Configuring Shift start is only relevant when the QC algorithm configuration item value is Shift or Shift
(alternating QC level). Configuration You configure the Shift start configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics QC algorithm (376) Shift length (in hours) (378) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 380 QC configuration Test strip count This configuration item specifies the number of successful tests that are performed after which a QC lockout is enabled. QC tests and unsuccessful tests are not included in the calculation. Test strip count works in conjunction with the QC algorithm configuration item. Item ID QC_STRIP_COUNT Available values/format 1 - 999 (default: 50) Values must be integers. Dependencies Configuring Test strip count is only relevant when the QC algorithm configuration item value is Test strip count or Test strip count (alternating QC level). Configuration You configure the Test strip count configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics QC algorithm (376) This configuration item determines the times of day at which QC lockouts are activated. A maximum of 6 lockouts can be scheduled. The lockouts occur each day. Time of day works in conjunction with the QC algorithm configuration item. Time of day n o i t a r u g i f n o c l a i t i n I 0 1 Available values/format A time must be entered as "HH:MM" and separated by commas. The times must be inside quotation marks (" ") Item ID QC_TIME_OF_DAY Examples:
"00:00"
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 QC tests required for new test strip lots Initial configuration 381
"06:00,12:00,18:00"
"02:00,06:00,10:00,14:00,18:00,22:00"
"06:00" (default) Dependencies Configuring Time of day is only relevant when the QC algorithm configuration item value is Time of day or Time of day (alternating QC level). Configuration You configure the Time of day configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics QC algorithm (376) This configuration item specifies if a new test strip lot can be used directly for patient testing, or whether a new test strip lot must first pass QC tests successfully. QC tests required for new test strip lots works in conjunction with the QC algorithm configuration item. Item ID QC_NEEDED_FOR_NEW_STRIP_LOTS Available values/format Disabled (default)
[false]
Enabled
[true]
A test strip lot can be used without passing a QC test. A test strip lot cannot be used without passing a QC test. Dependencies Configuring QC tests required for new test strip lots is only relevant when the QC algorithm configuration item value is not Disabled. Configuration You configure the QC tests required for new test strip lots configuration item using the following methods:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 382 QC configuration Show numeric QC result value This configuration item specifies how a QC test result is displayed. Item ID QC_RESULT_DISPLAY Available values/format Enabled (default) The result is displayed as a "Pass" or "Fail" together with a numeric value.
[true]
Disabled
[false]
The result is displayed as a "Pass" or a "Fail" only. Configuration You configure the Show numeric QC result value configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) QC range handling Allowed deviation for QC level 1 result In this section Allowed deviation for QC level 1 result(382) Allowed deviation for QC level 2 result(383) This configuration item specifies the permissible deviation from the level 1 QC material target value for which a QC result is valid. The custom deviation configuration depends upon the QC version. The QC version defines the target values
(level 1 and level 2) of a QC kit provided by Roche. The QC version ranges from 0 to 9. The QC version of a QC kit is located in Settings > Lot management > Lot management > QC lots. The initial QC version at product launch is 0. Item ID GLU_QC_CUSTOM_DEVIATION_L1 Available values/format SET of value pairs (comma separated) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a i t i n I 0 1 Initial configuration 383 The accepted maximum deviation values (for result unit mg/dL or mmol/L) are defined by Roche (see package insert of cobasGLU QC kit). Custom deviation values which exceed the permitted deviation defined by Roche will be rejected by the instrument. If the configuration item is empty (default) or the QC version is set to "0:0", no custom deviation is used. If a QC version is listed twice (misconfiguration), the value of the last entry in the list is used as the custom deviation. Example 1:
"0:6" = using a custom deviation of 6 mg/dL for QC version 0. Example 2:
"0:0.3" = using a custom deviation of 0.3 mmol/L for QC version 0. Example3:
"0:6,1:7" = using a custom deviation of 6 mg/dL for QC version 0 and 7mg/dL for QC version 1. Example4:
"0:0" = no custom deviation is used. Dependencies The allowed deviation is dependent on the Result unit
(glucose tests) configuration item, i.e. mmol/L or mg/
dL. The instrument rejects custom deviation values which exceed the allowed deviation defined by Roche. See the package insert of cobasGLU QC kit for the deviations defined by Roche. Configuration You configure the Allowed deviation for QC level 1 result configuration item using the following methods:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Allowed deviation for QC level 2 result This configuration item specifies the permissible deviation from the level 2 target value for which a QC result is valid. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a i t i n I 0 1 384 QC configuration Item ID GLU_QC_CUSTOM_DEVIATION_L2 Available values/format SET of value pairs (comma separated):
The custom deviation configuration depends upon the QC version. The QC version defines the target values
(level 1 and level 2) of a QC kit provided by Roche. The QC version ranges from 0 to 9. The QC version of a QC kit is located in Settings > Lot management > Lot management > QC lots. The initial QC version at product launch is 0. The accepted maximum deviation values (for result unit mg/dL or mmol/L) are defined by Roche (see package insert of cobasGLU QC kit). Custom deviation values which exceed the permitted deviation defined by Roche will be rejected by the instrument. If the configuration item is empty (default) or the QC version is set to "0:0", no custom deviation is used. If a QC version is listed twice (misconfiguration), the value of the last entry in the list is used as the custom deviation. Example 1:
"0:35" = using a custom deviation of 35 mg/dL for QC version 0. Example 2:
"0:1.9" = using a custom deviation of 1.9 mmol/L for QC version 0. Example3:
"0:35,1:37" = using a custom deviation of 35 mg/dL for QC version 0 and 37 mg/dL for QC version 1. Example4:
"0:0" = no custom deviation is used. n o i t a r u g i f n o c l a i t i n I 0 1 Dependencies The allowed deviation is dependent on the Result unit
(glucose tests) configuration item, i.e. mmol/L or mg/
dL. Configuration You configure the Allowed deviation for QC level 2 result configuration item using the following methods:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 385 Data deletion Result deletion Result deletion algorithm In this section Result deletion(385) Audit trail retention period (in days)(387) In this section Result deletion algorithm(385) Result retention period (in days)(386) Result upload required before result deletion(386) This configuration item specifies how test results are deleted from the instrument. Item ID RESULT_DELETION_ALGO Available values/format First-in first-out (default)
[FIFO]
Deletion is based on the FIFO (first in, first out) algorithm. Based on configured result retention period
[AUTOMATIC]
Deletion is based on retention time and successful transmission to the DMS (see the Result upload required before result deletion configuration item). Dependencies Result retention period (in days) if value is based on configured result retention period Result upload required before result deletion Configuration You configure the Result deletion algorithm configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Result upload required before result deletion (386) Result retention period (in days) (386) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 386 Data deletion Result retention period (in days) This configuration item specifies the length of time that test results are retained on the instrument. It determines the number of days since a result was measured before it can be automatically deleted. Deletion is triggered after the first DMS synchronization of each day. The value "0 days" means that the result is deleted when the next deletion is triggered. Item ID RESULT_RETENTION_TIME_IN_DAYS Available values/format 0-1000 days (default: 30 days) Dependencies It is only enabled when the Result deletion algorithm configuration item has the value Based on configured result retention period. Configuration You configure the Result retention period (in days) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Result deletion algorithm (385) n o i t a r u g i f n o c l a i t i n I 0 1 Result upload required before result deletion This configuration item specifies if a result must have been uploaded to the DMS before it can be deleted. Item ID RESULT_UPLOAD_REQUIRED Available values/format Disabled (default) A result does not need to be uploaded to the DMS before it can be deleted.
[false]
Enabled
[true]
A result must have been uploaded to the DMS before it can be deleted. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Audit trail retention period (in days) Initial configuration 387 Dependencies If there is no DMS a value of Disabled must be set. Configuration You configure the Result upload required before result deletion configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Result deletion algorithm (385) This configuration item specifies when audit trail entries are deleted. It works in conjunction with test result deletion. Audit trail entries are deleted after the sum of the Result retention period (in days) and Audit trail retention period (in days) configuration items has elapsed. Item ID AUDIT_TRAIL_RETENTION_TIME_IN_DAYS Available values/format 0-1000 days (default: 30 days) Dependencies The Audit trail retention period (in days) is only enabled when the Result deletion algorithm configuration item has a value of Based on configured result retention period. Configuration You configure the Audit trail retention period (in days) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Result deletion algorithm (385) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 388 Barcode camera configuration Barcode camera configuration In this section Minimum barcode scanning time(388) Checksum validation of barcode type "Interleaved 2 of 5"(388) Minimum barcode scanning time This configuration item specifies the minimum amount of time in milliseconds (ms), that the barcode camera preview window must focus on a barcode to ensure that it is read. Item ID BCS_BARCODE_FOCUS_TIMESPAN Available values/format 0 ms (default)
(deactivates the focus scanning time) 700 - 9999 ms
(1 - 699 ms are invalid) Format:
[0]|[789][0-9]{2}|[123456789][0-9]{3}
Dependencies The Patient entry type configuration item has a value of Barcode. User authentication required has a value of Barcode. Configuration You configure the Minimum barcode scanning time configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Checksum validation of barcode type "Interleaved 2 of 5"
This configuration item validates scanned patient ID and user ID barcodes when they are of the "Interleaved 2 of 5" barcode type. Item ID BCS_CODE_I2OF5_CHECKSUM Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 389 Available values/format Enabled (default) Disabled
[true]
[false]
Dependencies The configuration items Allowed barcode types for patient ID or Allowed barcode types for user ID have a value of Interleaved 2 of 5. Configuration You configure the Checksum validation of barcode type "Interleaved 2 of 5" configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 390 Connectivity Connectivity In this section Synchronization warning / lockout(390) DMS/cobas infinity edge connection retry timeout (in seconds)(392) DMS session timeout (in seconds)(392) DNS IPv4 address(393) DNS IPv6 address(393) Gateway IPv4 address(394) Gateway IPv6 address(395) Instrument IPv4 address(395) Instrument IPv6 address(396) IPv4 subnet mask(397) Network Time Protocol (NTP)(397) NTP server address (398) Instrument time zone(399) Data management system IP address / host name(400) Data management system port number(401) cobas infinity edge IP address / host name(401) cobas infinity edge port number(402) Wi-Fi connection(403) TLS security(414) In this section Show synchronization lockout warning prior to actual lockout (in hours)(390) Synchronization lockout (in hours)(391) This configuration item specifies the time in hours between the last data synchronization and displaying a warning. The warning indicates that there will be a lockout if a data synchronization does not take place. It works in conjunction with the Synchronization lockout (in hours) configuration item. Synchronization warning / lockout Show synchronization lockout warning prior to actual lockout (in hours) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 391 If a value of "0" is selected no warning is given. Item ID DMS_SYNCHRONIZATION_LOCKOUT_HOURS Available values/format 0-999 hours Default = "0"
Configuration You configure the Show synchronization lockout warning prior to actual lockout (in hours) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Synchronization lockout (in hours) (391) This configuration item specifies the time in hours between a data synchronization warning and a synchronization lockout if no synchronization takes place. It works in conjunction with the Show synchronization lockout warning prior to actual lockout (in hours) configuration item. If a value of "0" is selected synchronization lockout is disabled. Synchronization lockout (in hours) Item ID DMS_SYNCHRONIZATION_LOCKOUT_HOURS Available values/format 0-999 hours Default = "0"
Configuration You configure the Synchronization lockout (in hours) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Show synchronization lockout warning prior to actual lockout (in hours) (390) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 392 Connectivity DMS/cobas infinity edge connection retry timeout (in seconds) DMS session timeout (in seconds) This configuration item specifies the time, in seconds, that the instrument will try to establish a connection to the intended systems (DMS or cobas infinity edge). Item ID CONNECTION_TIMEOUT_IN_SECONDS Available values/format 10-180 seconds
(default=60) Configuration You configure the DMS/cobas infinity edge connection retry timeout (in seconds) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item specifies the application-level timeout the instrument uses for communication with the DMS. It is the amount of time, in seconds, that the instrument will wait for the next message from the DMS before terminating the connection. Item ID CONVERSATION_TIMEOUT_IN_SECONDS Available values/format 30-3600 seconds
(default=60) Dependencies The Data management system IP address / host name configuration item is not empty. Configuration You configure the DMS session timeout (in seconds) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a i t i n I 0 1 Initial configuration 393 DNS IPv4 address This configuration item specifies the DNS IPv4 address. Item ID DNS_IP4_ADDRESS Available values/format 0.0.0.0 255.255.255.255 Dependencies If the Use DHCP configuration item has a value of Yes, the instrument will normally receive this value automatically (depending on the DHCP server configuration) and this configuration item can remain empty. If the Use DHCP configuration item has a value of No, and the instrument uses host names, this configuration item must be set. Configuration You configure the DNS IPv4 address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) DNS IPv6 address This configuration item specifies the DNS IPv6 address. Item ID DNS_IP6_ADDRESS Available values/format Only the preferred form"(4) is supported. Compressing zeros, mixed IPv6/IPv4 representations or scoped addresses are not supported. Examples:
fd00:0:0:0:4533:4431:55b5:b46 is supported. fd00:0000:0000:0000:4533:4431:55b5:b46 is supported. fd00::4533:4431:55b5:b46 is not supported due to compressed zeros. fd00:0000:0000:0000:4533:4431:85.181.11.70 is not supported due to mixed IPv6/IPv4 notation. n o i t a r u g i f n o c l a i t i n I 0 1
(4) RFC 2373 (paragraph 2.2 1.) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 394 Connectivity Dependencies Adherence to the supported form can be checked using the following regular expression:
((?:[A-Fa-f0-9]{1,4}:){7}[A-Fa-f0-9]{1,4})?
If the Use DHCP configuration item has a value of Yes, the instrument will normally receive this value automatically (depending on the DHCP server configuration) and this configuration item can remain empty. If the Use DHCP configuration item has a value of No, and the instrument uses host names, this configuration item must be set. Configuration You configure the DNS IPv6 address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Gateway IPv4 address This configuration item specifies the gateway IPv4 address. Item ID GATE_IP4_ADDRESS Available values/format 0.0.0.0 255.255.255.255 Dependencies If the Use DHCP configuration item has a value of Yes, the instrument will normally receive this value automatically (depending on the DHCP server configuration) and this configuration item can remain empty. If the Use DHCP configuration item has a value of No, this configuration item must be set. Configuration You configure the Gateway IPv4 address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 395 Gateway IPv6 address This configuration item specifies the gateway IPv6 address. Item ID GATE_IP6_ADDRESS Available values/format Only the preferred form"(5) is supported. Compressing zeros, mixed IPv6/IPv4 representations or scoped addresses are not supported. Examples:
fd00:0:0:0:4533:4431:55b5:b46 is supported. fd00:0000:0000:0000:4533:4431:55b5:b46 is supported.fd00::4533:4431:55b5:b46 is not supported due to compressed zeros. fd00:0000:0000:0000:4533:4431:85.181.11.70 is not supported due to mixed IPv6/IPv4 notation. Adherence to the supported form can be checked using the following regular expression:
((?:[A-Fa-f0-9]{1,4}:){7}[A-Fa-f0-9]{1,4})?
If the Use DHCP configuration item has a value of Yes, the instrument will normally receive this value automatically (depending on the DHCP server configuration) and this configuration item can remain empty. If the Use DHCP configuration item has a value of No, this configuration item must be set. Dependencies Configuration You configure the Gateway IPv6 address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Instrument IPv4 address This configuration item specifies the instrument IPv4 address.
(5) RFC 2373 (paragraph 2.2 1.) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 396 Connectivity Item ID INSTRUMENT_IP4_ADDRESS Available values/format 0.0.0.0 255.255.255.255 Dependencies If the Use DHCP configuration item has a value of Yes, the instrument will normally receive this value automatically (depending on the DHCP server configuration) and this configuration item can remain empty. If the Use DHCP configuration item has a value of No, this configuration item must be set. If this configuration item is set, the instrument will ignore the value set in the Instrument IPv6 address DNS IPv6 address configuration item as the operating system only allows one static IP address to be set. Configuration You configure the Instrument IPv4 address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Instrument IPv6 address This configuration item specifies the instrument IPv6 address with IPv6 prefix. Item ID INSTRUMENT_IP6_ADDRESS Available values/format Only the preferred form(6) is supported. Compressing zeros, mixed IPv6/IPv4 representations or scoped addresses are not supported. Examples:
fd00:0:0:0:4533:4431:55b5:b46 is supported. fd00:0000:0000:0000:4533:4431:55b5:b46 is supported. fd00::4533:4431:55b5:b46 is not supported due to compressed zeros. fd00:0000:0000:0000:4533:4431:85.181.11.70 is not supported due to mixed IPv6/IPv4 notation. n o i t a r u g i f n o c l a i t i n I 0 1
(6) RFC 2373 (paragraph 2.2 1.) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 397 Adherence to the supported form can be checked using the following regular expression:
((?:[A-Fa-f0-9]{1,4}:){7}[A-Fa-f0-9]{1,4})?
Dependencies If this configuration item is set, the Instrument IPv4 address configuration item must not be used. If the Instrument IPv4 address configuration item is set, the instrument will ignore the value set in this configuration item as the operating system only allows one static IP address to be set. Configuration You configure the Instrument IPv6 address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) IPv4 subnet mask This configuration item specifies the IPv4 subnet mask. Item ID IP4_SUBNET_MASK Available values/format 0.0.0.0 255.255.255.255 Dependencies If the Use DHCP configuration item has a value of Yes, the instrument will normally receive this value automatically (depending on the DHCP server configuration) and this configuration item can remain empty. If the Use DHCP configuration item has a value of No, this configuration item must be set. Configuration You configure the IPv4 subnet mask configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Network Time Protocol (NTP) This configuration item specifies if the instrument uses the Network Time Protocol (NTP). Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 398 Connectivity NTP servers can either be provided as part of the DHCP protocol, or specified via the NTP server address configuration item. Item ID NTP_ENABLED Available values/format Enabled (default)
[true]
The instrument enables the NTP and prevents the time from being set by POCT1-A. Disabled
[false]
The instrument deactivates the NTP. If the Network Time Protocol (NTP) configuration is enabled, the NTP server address is required. The time zone must be configured in the Instrument time zone configuration item. Dependencies Configuration You configure the Network Time Protocol (NTP) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item specifies the address of the NTP server. The NTP server can either have a machine name, such as "ntp.hospital.com", or a "textual representation" of its IP address. If a literal IP address is supplied, only the validity of the address format is checked. For a host specified as an IPv6 address, either the form defined in RFC 2732, or the literal IPv6 address format defined in RFC 2373 are acceptable. IPv6 scoped addresses are also supported. NTP server address n o i t a r u g i f n o c l a i t i n I 0 1 Item ID NTP_SERVER Available values/format 0-60 characters Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Instrument time zone Initial configuration 399 Dependencies Depending on the DHCP server capabilities, the instrument automatically receives an NTP server address. If the DHCP server does not provide an NTP server address, the NTP server address configuration item must be set to a valid value. Configuration You configure the NTP server address configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item determines the time zone of the instrument taken from a subset of the ICANN/IANA time zone database (also referred to as Olson database). This time zone is used as the instrument time zone and will be taken into account when the instrument receives the actual time via NTP or via POCT1-A directive. If the Instrument time zone configuration item is not set to a dedicated time zone (e.g., Europe/Berlin), then the daylight saving logic is not active. Item ID TIME_ZONE Available values/format 0-50 characters Etc./GMT (default) For a list of valid time zones refer to the appropriate subset of the ICANN/IANA time zone database. Dependencies The Network Time Protocol (NTP) configuration item is set to Enabled. Configuration You configure the Instrument time zone configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 400 Connectivity Data management system IP address / host name Item ID DMS_Host Available values/format 0-60 characters This configuration item specifies the DMS IP address /
host name. It can either be a machine name, such as
"dms.hospital.com", or a textual representation of its IP address. If a literal IP address is supplied, only the validity of the address format is checked. For a host specified as a literal IPv6 address, only the preferred form according to RFC 2373 (paragraph 2.2 1.) is supported. Compressing zeros, mixed IPv6/IPv4 representations or scoped addresses are not supported. Examples:
fd00:0:0:0:4533:4431:55b5:b46 is supported. fd00:0000:0000:0000:4533:4431:55b5:b46 is supported. fd00::4533:4431:55b5:b46 is not supported due to compressed zeros. fd00:0000:0000:0000:4533:4431:85.181.11.70 is not supported due to mixed IPv6/IPv4 notation. Adherence to the permitted form can be checked using the following regular expression: ((?:[A-Fa-f0-9]{1,4}:){7}
[A-Fa-f0-9]{1,4})?
If this configuration item remains empty, the instrument will not communicate to any DMS and therefore will not log any issues related to DMS communication in the audit trail. n o i t a r u g i f n o c l a i t i n I 0 1 Dependencies cobas infinity edge only:
If the instrument will only be connected to cobas infinity edge, the Data management system IP address / host name configuration item must not be set. cobas infinity edge and DMS:
The Data management system IP address / host name and the Data management system port number must be set. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 401 Configuration You configure the Data management system IP address / host name configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Data management system port number This configuration item specifies the DMS port number. Item ID DMS_PORT Available values/format 0 (default)-65535 Dependencies cobas infinity edge only:
If the instrument will only be connected to cobas infinity edge, the cobas infinity edge IP address / host name and cobas infinity edge port number configuration items must be set. cobas infinity edge and DMS:
The Data management system port number and Data management system IP address / host name must be set. Configuration You configure the Data management system port number configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item specifies the cobas infinity edge IP address / host name. It can either be a machine name, such as
"rsg.hospital.com", or a textual representation of its IP address. If a literal IP address is supplied, only the validity of the address format is checked. n o i t a r u g i f n o c l a i t i n I 0 1 cobas infinity edge IP address / host name Item ID RSG_HOST Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 402 Connectivity Available values/format 0-60 characters For a host specified in literal IPv6 address, only the preferred form according to RFC 2373 (paragraph 2.2 1.) is supported. Compressing zeros, mixed IPv6/IPv4 representations or scoped addresses are not allowed. Examples:
fd00:0:0:0:4533:4431:55b5:b46 is supported. fd00:0000:0000:0000:4533:4431:55b5:b46 is supported. fd00::4533:4431:55b5:b46 is not supported due to compressed zeros. fd00:0000:0000:0000:4533:4431:85.181.11.70 is not supported due to mixed IPv6/IPv4 notation. Adherence to the permitted form can be checked using the following regular expression:
((?:[A-Fa-f0-9]{1,4}:){7}[A-Fa-f0-9]{1,4})?
cobas infinity edge only:
If the instrument will only be connected to cobas infinity edge, the cobas infinity edge IP address / host name and cobas infinity edge port number configuration items must be set. cobas infinity edge and DMS:
The cobas infinity edge IP address / host name configuration item must be set by the DMS. Dependencies n o i t a r u g i f n o c l a i t i n I 0 1 Configuration You configure the cobas infinity edge IP address /
host name configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) cobas infinity edge port number This configuration item specifies the "cobas infinity edge port number". Item ID RSG_PORT Available values/format 0 (default)-65535 characters Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Wi-Fi connection Initial configuration 403 Dependencies cobas infinity edge only:
The cobas infinity edge port number configuration item is shown. If the instrument will only be connected to cobas infinity edge, the cobas infinity edge port number and cobas infinity edge IP address / host name configuration items must be set. cobas infinity edge and DMS:
The cobas infinity edge port number configuration item must be set by the DMS. Configuration You configure the cobas infinity edge port number configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) User interface (only during initial configuration) User interface Use domain name system (DNS)?(405) In this section Wi-Fi SSID(404) Use DHCP(404) Anonymous User(406) CA Certificate(406) Client Certificate(407) User Name(407) Password(408) Client private key password(408) Client private key(408) EAP Type(409) Wi-Fi security type(410) Wi-Fi key type(410) Wi-Fi encryption key(411) Wi-Fi password(411) Wi-Fi cryptographic algorithm type(412) List of Wi-Fi security configurations(412) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 404 Connectivity Wi-Fi SSID This configuration item specifies the Service Set Identifier
(SSID) of the Wi-Fi network. Item ID SSID_WLAN_1 Available values/format 0-32 characters Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Wi-Fi SSID configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Use DHCP This configuration item specifies if the Dynamic Host Configuration Protocol (DHCP) is used. Item ID USE_DHCP_BOOL_WLAN_1 Available values/format Yes (default) Dependencies If the DHCP is enabled, the instrument will automatically receive the following information from the DHCP server
(consequently these configuration items remain empty:
[true]
DHCP is enabled. No
[false]
DHCP is disabled. DNS IPv4 address Gateway IPv4 address Instrument IPv4 address IPv4 subnet mask DNS IPv6 address Gateway IPv6 address Instrument IPv6 address n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 405 If the DHCP is disabled, the instrument either needs to have a valid static IP configuration either as IP4 (DNS IPv4 address, Gateway IPv4 address, Instrument IPv4 address, IPv4 subnet mask), or as IP6 (DNS IPv6 address, Gateway IPv6 address, Instrument IPv6 address). Configuration You configure the Use DHCP configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Use domain name system (DNS)?
This configuration item specifies the use of the DNS
(Domain Name System). Item ID USE_DNS_BOOL_WLAN_1 Available values/format Yes (default)
[true]
DNS is enabled. No
[false]
DNS is disabled. Dependencies If DNS use is enabled, configuration items defining host machines/servers (Data management system IP address / host name, cobas infinity edge IP address / host name, NTP server address) can be set as fully qualified domain names (FQDN). If DNS use is disabled, configuration items defining host machines/servers (Data management system IP address / host name, cobas infinity edge IP address / host name, NTP server address) must be set as IP addresses. Configuration You configure the Use domain name system (DNS)?
configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 406 Connectivity Anonymous User This configuration item specifies the EAP anonymous user. Item ID EAP_ANONYMOUS_IDENTITY_WLAN_1 Available values/format 0-64 characters Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Anonymous User configuration item using the following:
Data management system (e.g., cobas infinity POC) This configuration item specifies the EAP CA certificate
(X.509). Supported formats are "PEM" and "DER". The file must be stored as a Base64 encoded string.
"PEM" can contain both the certificate and private key. The PEM file must not contain the server's private key. Item ID EAP_CA_CERT_WLAN_1 Available values/format 0-25000 characters (content must be Base64 encoded) Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the CA Certificate configuration item using the following:
Data management system (e.g., cobas infinity POC) CA Certificate n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 407 Client Certificate This configuration item specifies the EAP client certificate. Supported formats are "PEM" and "DER". The file must be stored as a Base64 encoded string.
"PEM" can contain both the certificate and private key. However, the private key will be ignored if stored in this configuration item. Item ID EAP_CLIENT_CERT_WLAN_1 Available values/format 0-25000 characters (content must be Base64 encoded) Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Client Certificate configuration item using the following:
Data management system (e.g., cobas infinity POC) User Name This configuration item specifies the EAP user name. Item ID EAP_IDENTITY_WLAN_1 Available values/format 0-64 characters Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the User Name configuration item using the following:
Data management system (e.g., cobas infinity POC) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 408 Connectivity Password Client private key password This configuration item specifies the EAP password. Item ID EAP_PASSWORD_WLAN_1 Available values/format 0-64 characters Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Password configuration item using the following:
Data management system (e.g., cobas infinity POC) This configuration item specifies the password for the EAP client private key. It is necessary if the private key is stored as encrypted
"PKCS#12" or encrypted "PEM". Item ID EAP_PRIVATE_KEY_PASSWORD_WLAN_1 Available values/format 0-64 characters Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Client private key password configuration item using the following:
Data management system (e.g., cobas infinity POC) Client private key This configuration item specifies the EAP client private key. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a i t i n I 0 1 Initial configuration 409 Supported formats are "PEM" and "PKCS#12". The file must be stored as a Base64 encoded string.
"PEM" and "PKCS#12" can contain both the certificate and private key. If the private key is protected by a password (mandatory for "PKCS#12", optional for "PEM") this password must be stored in the Client private key password configuration item. Bundled certificates in the
"PKCS#12* or "PEM" are ignored. Item ID EAP_PRIVATE_KEY_WLAN_1 Available values/format 0-25000 characters (content must be Base64 encoded) Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Client private key configuration item using the following:
Data management system (e.g., cobas infinity POC) EAP Type This configuration item specifies the EAP type. Item ID EAP_TYPE_WLAN_1 Available values/format Disabled (default) [NOT_SET]
TLS
[TLS]
TTLS
[TTLS]
PEAP
[PEAP]
Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the EAP Type configuration item using the following:
Data management system (e.g., cobas infinity POC) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 410 Connectivity Wi-Fi security type This configuration item specifies the Wi-Fi security type.
"EAP " is not supported for barcode configuration. The necessary certificates cannot be set by barcode due to size constraints. CAUTION!
Wi-Fi security To avoid an unsecure Wi-Fi r Do not use open Wi-Fi. r Follow the cybersecurity best practice of your facility Item ID SECURITY_TYPE_WLAN_1 Available values/format Open Wi-Fi (default)
[OPEN]
WPA-PSK
[WPA_PSK]
Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Wi-Fi security type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Wi-Fi key type This configuration item specifies the Wi-Fi key type. Item ID WPA_KEY_TYPE_WLAN_1 Available values/format Passphrase (default)
[PASSPHRASE]
Encryption key
[KEY]
Dependencies Refer to the tables in "List of Wi-Fi security configurations". Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 411 u List of Wi-Fi security configurations (412) Configuration You configure the Wi-Fi key type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Wi-Fi encryption key This configuration item specifies the Wi-Fi encryption key. Item ID WPA_KEY_WLAN_1 Available values/format String of 64 characters (hexadecimal encoded) Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Wi-Fi encryption key configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Wi-Fi password This configuration item specifies the Wi-Fi password. Item ID WPA_PASS_PHRASE_WLAN_1 Available values/format 0.8-63 Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Wi-Fi password configuration item using the following:
Data management system (e.g., cobas infinity POC) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 412 Connectivity Wi-Fi cryptographic algorithm type Barcode (generated via cobas infinity edge) This configuration item specifies the Wi-Fi cryptographic algorithm type. Item ID CIPHER_TYPE_WLAN_1 Available values/format None (default)
[NONE]
AES
[AES]
TKIP
[TKIP]
AES+TKIP
[AES_TKIP]
Dependencies Refer to the tables in "List of Wi-Fi security configurations". u List of Wi-Fi security configurations (412) Configuration You configure the Wi-Fi cryptographic algorithm type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) List of Wi-Fi security configurations Valid Wi-Fi security configurations n o i t a r u g i f n o c l a i t i n I 0 1 Wi-Fi SSID Wi-Fi security type Wi-Fi key type Wi-Fi password Wi-Fi encryption key Wi-Fi cryptographic algorithm type Open WLAN 1-32 characters Open Wi-Fi 1-32 characters WPA-PSK None AES
Passphrase 8-63 characters 1-32 characters WPA-PSK AES Encryption key 64 Hex 1-32 characters WPA-PSK TKIP Passphrase 8-63 characters 1-32 characters WPA-PSK TKIP Encryption key 64 Hex WPA2 Personal
(passphrase) WPA2 Personal
(key) WPA Personal
(passphrase) WPA Personal
(key) y Valid Wi-Fi security configurations
characters characters
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 413 Wi-Fi SSID Wi-Fi security type Wi-Fi key type Wi-Fi password Wi-Fi encryption key Wi-Fi cryptographic algorithm type 1-32 characters WPA-PSK AES+TKIP Passphrase 8-63 characters 1-32 characters WPA-PSK AES+TKIP Encryption key 64 Hex characters 1-32 characters EAP AES
WPA/WPA2 Personal
(passphrase) WPA/WPA2 Personal (key) WPA2 Enterprise
(EAP) WPA Enterprise
(EAP) 1-32 characters EAP TKIP y Valid Wi-Fi security configurations Valid Wi-Fi EAP security configurations EAP (WPA/WPA2 Enterprise) is a Wi-Fi authentication method involving three parties:
Client cobas pulse Access Point (Router) Authentication Server (RADIUS) Their interconnectivity is as follows:
1. The client connects to the access point. 2. The access point connects to the authentication server, and acts like a proxy between the client and authentication server. 3. The authentication server tries to authenticate the client. 4. If the authentication is successful, the access point grants the client access to the network. If authentication fails, the access point rejects the client. Supported EAP methods are as follows:
EAP-TLS EAP-TTLS EAP-PEAP Authentication is based on digital certificates. The client and authentication server must both have valid certificates, recognized by each other. Authentication is based on user name and password. The client must have a valid account on the authentication server. Authentication is based on user name and password. The client must have a valid account on the authentication server. From a configuration perspective, the EAP-TTLS and EAP-PEAP methods are identical. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 414 Connectivity EAP Type Anonymous User CA Certificate Optional Optional Optional Optional Optional Optional Client Certificate Client private key Client private key password Required
User Name Password
Required Required TLS TTLS PEAP y Valid Wi-Fi EAP security configurations TLS security DMS TLS certificate check Item ID CERTIFICATE_CHECK_TLS_DMS Available values/format Disabled In this section DMS TLS certificate check(414) cobas infinity edge TLS certificate check(415) DMS TLS level(416) DMS TLS certificate(417) DMS TLS certificate password(418) cobas infinity edge TLS level(418) This configuration item determines the level of TLS server certificate check for connecting to DMS The Disabled option also allows a TLS handshake if no certificates are stored in the related configuration items.
[DEACTIVATED]
No certificate check is made. Warning (default)
[WARNING]
The corresponding TLS server certificate is checked. In case the certificate check fails, a warning will be logged in the audit trail and the TLS connection will be established. Strict
[STRICT]
The corresponding TLS server certificate will be checked. In case the certificate check fails, an error will be logged in the audit trail and no connection will be established. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 cobas infinity edge TLS certificate check Initial configuration 415 Dependencies This configuration item is only relevant when the DMS TLS level is set to TLS enabled or TLS enabled (FIPS approved mode). Configuration You configure the DMS TLS certificate check configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Item ID CERTIFICATE_CHECK_TLS_RSG Available values/format Disabled This configuration item determines the level of TLS certificate check for a connection to cobas infinity edge. Changing the cobas infinity edge TLS level must only be done after contacting your Roche representative.
[DEACTIVATED]
No certificate check is made. Warning
[WARNING]
The corresponding TLS server certificate is checked. In case the certificate check fails, a warning will be logged in the audit trail and the TLS connection will be established. Strict (default)
[STRICT]
The corresponding TLS server certificate will be checked. In case the certificate check fails, an error will be logged in the audit trail and no connection will be established Dependencies This configuration item is only relevant when the cobas infinity edge TLS level is set to TLS enabled or TLS enabled (FIPS approved mode). Configuration You configure the cobas infinity edge TLS certificate check configuration item using the following:
Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 416 Connectivity DMS TLS level This configuration item determines the TLS security level which is used for the connection to the DMS. Depending on the capabilities of a third party DMS, this configuration item needs to be set to TLS disabled. The instrument only accepts TLSv1.2 and the following cipher suites are supported:
TLS_ECDHE_ECDSA_WITH_AES_256_GCM_SHA384 TLS_ECDHE_ECDSA_WITH_AES_256_CBC_SHA384 TLS_ECDHE_ECDSA_WITH_CHACHA20_POLY1305_S HA256 TLS_ECDHE_RSA_WITH_AES_256_GCM_SHA384 TLS_ECDHE_RSA_WITH_AES_256_CBC_SHA384 TLS_ECDHE_RSA_WITH_CHACHA20_POLY1305_SH A256 TLS_DHE_RSA_WITH_AES_256_GCM_SHA384 TLS_DHE_RSA_WITH_AES_256_CBC_SHA256 TLS_DHE_RSA_WITH_AES_256_CCM TLS_DHE_RSA_WITH_AES_256_CCM_8 TLS_ECDHE_ECDSA_WITH_AES_256_CCM_8 TLS_ECDHE_ECDSA_WITH_AES_256_CCM TLS_ECDHE_ECDSA_WITH_AES_128_GCM_SHA256 TLS_ECDHE_ECDSA_WITH_AES_128_CBC_SHA256 TLS_ECDHE_ECDSA_WITH_AES_128_CCM TLS_ECDHE_ECDSA_WITH_AES_128_CCM_8 TLS_ECDHE_RSA_WITH_AES_128_GCM_SHA256 TLS_ECDHE_RSA_WITH_AES_128_CBC_SHA256 TLS_DHE_RSA_WITH_AES_128_GCM_SHA256 TLS_DHE_RSA_WITH_AES_128_CBC_SHA256 TLS_DHE_RSA_WITH_AES_128_CCM_8 TLS_DHE_RSA_WITH_AES_128_CCM TLS_DHE_DSS_WITH_AES_256_GCM_SHA384 TLS_DHE_DSS_WITH_AES_256_CBC_SHA256 TLS_DHE_DSS_WITH_AES_128_GCM_SHA256 TLS_DHE_DSS_WITH_AES_128_CBC_SHA256 n o i t a r u g i f n o c l a i t i n I 0 1 Item ID TLS_LEVEL_DMS Available values/format TLS disabled
[TLS_DISABLED]
TLS not used. TLS enabled (default)
[FIPS_NON_APPROVED_MODE]
TLS used in FIPS non-approved mode. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 417 TLS enabled (FIPS approved mode)
[FIPS_APPROVED_MODE]
TLS used in FIPS approved mode. i The cobas pulse instrument uses a cryptographic library which offers a "FIPS approved" mode. For more information about the FIPS140-2 status of cobas pulse, contact you Roche representative. Dependencies If the DMS TLS level configuration item is set to TLS disabled or to TLS enabled (FIPS approved mode), the DMS TLS certificate check configuration item must be set accordingly. Configuration You configure the DMS TLS level configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) DMS TLS certificate This configuration item specifies the certificate chain that allows the validation of the DMS server certificate. Allowed formats: PEM, PKCS#12. The file must be stored as a Base64 encoded string. The DMS TLS certificate configuration item may be provided in pfx file format which can contain a set of certificates. If the KeyUsage extension is defined in the certificate and security services other than certificate signing or certificate revocation list signing are supported (e.g., encipher data), the instrument TLS library validates that the digitalSignature bit is set in KeyUsage, otherwise the certificate is not accepted (even if DMS TLS certificate check is deactivated). n o i t a r u g i f n o c l a i t i n I 0 1 Item ID DMS_TLS_CERTIFICATE Available values/format 0-50000 characters (content must be Base64 encoded) The cobas pulse instrument contains a pre-installed Roche certificate chain.For further information about certificate usage refer to the cobas pulse connectivity guide. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 418 Connectivity DMS TLS certificate password Dependencies If the DMS TLS level configuration item is set to TLS enabled or to TLS enabled (FIPS approved mode), there must be a valid certificate stored in the DMS TLS certificate configuration item. Configuration You configure the DMS TLS certificate configuration item using the following:
Data management system (e.g., cobas infinity POC) This configuration item specifies the password which is necessary if the DMS TLS certificate is stored as PFX. Item ID DMS_TLS_CERTIFICATE_PASSWORD Available values/format The initial certificate is stored during production
(default). 0-64 Dependencies This configuration item is required when the DMS_TLS_CERTIFICATE_FORMAT is PKCS#12. Configuration You configure the DMS TLS certificate password configuration item using the following:
Data management system (e.g., cobas infinity POC) cobas infinity edge TLS level n o i t a r u g i f n o c l a i t i n I 0 1 This configuration item determines the TLS security level which is used for the connection to the cobas infinity edge. Changing the cobas infinity edge TLS level must only be done after contacting your Roche representative. The instrument only accepts TLSv1.2 and the following cipher suites are supported:
TLS_ECDHE_ECDSA_WITH_AES_256_GCM_SHA384 TLS_ECDHE_ECDSA_WITH_AES_256_CBC_SHA384 TLS_ECDHE_ECDSA_WITH_CHACHA20_POLY1305_S HA256 TLS_ECDHE_RSA_WITH_AES_256_GCM_SHA384 TLS_ECDHE_RSA_WITH_AES_256_CBC_SHA384 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Initial configuration 419 TLS_ECDHE_RSA_WITH_CHACHA20_POLY1305_SH A256 TLS_DHE_RSA_WITH_AES_256_GCM_SHA384 TLS_DHE_RSA_WITH_AES_256_CBC_SHA256 TLS_DHE_RSA_WITH_AES_256_CCM TLS_DHE_RSA_WITH_AES_256_CCM_8 TLS_ECDHE_ECDSA_WITH_AES_256_CCM_8 TLS_ECDHE_ECDSA_WITH_AES_256_CCM TLS_ECDHE_ECDSA_WITH_AES_128_GCM_SHA256 TLS_ECDHE_ECDSA_WITH_AES_128_CBC_SHA256 TLS_ECDHE_ECDSA_WITH_AES_128_CCM TLS_ECDHE_ECDSA_WITH_AES_128_CCM_8 TLS_ECDHE_RSA_WITH_AES_128_GCM_SHA256 TLS_ECDHE_RSA_WITH_AES_128_CBC_SHA256 TLS_DHE_RSA_WITH_AES_128_GCM_SHA256 TLS_DHE_RSA_WITH_AES_128_CBC_SHA256 TLS_DHE_RSA_WITH_AES_128_CCM_8 TLS_DHE_RSA_WITH_AES_128_CCM TLS_DHE_DSS_WITH_AES_256_GCM_SHA384 TLS_DHE_DSS_WITH_AES_256_CBC_SHA256 TLS_DHE_DSS_WITH_AES_128_GCM_SHA256 TLS_DHE_DSS_WITH_AES_128_CBC_SHA256 TLS enabled
[FIPS_NON_APPROVED_MODE]
TLS used in FIPS non approved mode. TLS enabled (FIPS approved mode) (default)
[FIPS_APPROVED_MODE]
TLS usage in FIPS approved mode. i The cobas pulse uses a cryptographic library which offers a "FIPS approved" mode. For more information about the FIPS140-2 status of cobas pulse, contact you Roche representative. Dependencies If cobas infinity edge TLS level is set to TLS enabled or TLS enabled (FIPS approved mode), the cobas infinity edge TLS certificate check configuration item must be set accordingly. Configuration You configure the cobas infinity edge TLS level configuration item using the following:
Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a i t i n I 0 1 Item ID TLS_LEVEL_RSG Available values/format Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 420 Connectivity Page intentionally left blank. n o i t a r u g i f n o c l a i t i n I 0 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 421 General configuration In this chapter List of power management options ................................ Standby timeout .......................................................... Lift to wake.................................................................... Patient ID handling................................................................ Patient ID entry interfaces ....................................... Patient entry type............................................. Patient entry keyboard type ......................... Patient ID validation................................................... Patient ID validation........................................ Patient ID pattern validation (keyboard). Patient ID pattern validation (barcode) ... Patient ID pattern validation (RFID).......... Patient ID confirmation dialog ............................... Patient ID autocomplete........................................... Allowed barcode types for patient ID ................. User ID handling .................................................................... User ID entry interfaces............................................ User authentication required ...................... User authentication type............................... User authentication keyboard type........... User ID validation ....................................................... User ID validation ............................................ User ID pattern validation (keyboard)...... User ID pattern validation (barcode)........ User ID pattern validation (RFID) .............. User ID handling ......................................................... Minimum password length .......................... Logon session timeout................................... Show user lockout warning prior to user certificate expiration ............................. 11 425 425 425 427 427 427 428 428 429 430 431 433 434 435 436 437 437 437 438 439 439 439 440 441 443 444 444 445 445 n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 422 Table of contents User ID autocomplete .................................... Allowed barcode types for user ID....................... Result range handling.......................................................... Normal range lower limit ......................................... Normal range upper limit......................................... Critical range lower limit .......................................... Critical range upper limit ......................................... Reportable range lower limit .................................. Reportable range upper limit ................................. Message displayed if the result is below the reportable range.......................................................... Custom message (below reportable range) ..... Message displayed if the result is above the reportable range.......................................................... Custom message (above reportable range) ..... Custom message (above critical range)............. Custom message (below critical range)............. Message displayed if the result is above the critical range................................................................. Message displayed if the result is below the critical range................................................................. Measurement workflow....................................................... Emergency workflow ................................................. Allow emergency tests................................... Default patient ID for emergency tests ... Test strip ejection........................................................ Sample type .................................................................. Result unit (glucose tests)....................................... Configure override QC .............................................. Allow QC / synchronization lockout overrides.............................................................. Number of lockout overrides allowed...... Comment management............................................ Allow user-defined comments.................... Condition for required comments on patient results.................................................... Allow comments on patient results .......... Allow comments on QC results .................. Generic instrument functionality...................................... Access restrictions ..................................................... Instrument settings password..................... 446 447 448 448 449 449 450 451 451 452 453 454 454 455 456 456 457 458 458 458 459 459 460 460 461 461 462 462 463 464 464 465 467 467 467 n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Table of contents 423 Allow configuration by barcode on the instrument........................................................... Access restrictions to date and time........ Allow access to administrator features ... Allow access to lot management on the instrument........................................................... Lot management ......................................................... Allow linearity lot selection from list......... Allow QC lot selection from list .................. Instrument site, location, and name .................... Site......................................................................... Location............................................................... Device name...................................................... RFID tag.......................................................................... Patient RFID tag record configuration ..... User RFID tag record configuration.......... RFID tag configuration................................... Tests menu .................................................................... Patient test series............................................. Allow linearity tests ......................................... Allow proficiency tests................................... Insulin dose entry ............................................ Startup behavior of the instrument ........... Message of the day......................................... Cleaning ......................................................................... Time interval for cleaning notification
(in hours)............................................................. Cleaning notification after each patient test......................................................................... 468 469 470 471 471 471 472 473 473 473 474 474 475 475 476 476 476 477 477 478 478 479 479 480 480 n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 424 Table of contents Page intentionally left blank. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 425 List of power management options In this section Standby timeout(425) Lift to wake(425) Standby timeout This configuration item specifies the time in seconds that an instrument is idle before switching to standby mode. Item ID ACTIVITY_TURN_OFF_IN_SECONDS Available values/format 30-3600 seconds
(default=300) Configuration You configure the Standby timeout configuration item using the following methods:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Lift to wake This configuration item specifies whether or not the instrument wakes from standby when lifted from rest
(movement is detected). Item ID LIFT_TO_WAKE Available values/format Disabled (default) Movement detection is disabled.
[false]
Enabled
[true]
Movement detection is enabled and the instrument wakes up when lifted. Configuration You configure the Lift to wake configuration item using the following methods:
n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 426 List of power management options Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 427 Patient ID handling Patient ID entry interfaces Patient entry type In this section Patient ID entry interfaces(427) Patient ID validation(428) Patient ID confirmation dialog(434) Patient ID autocomplete(435) Allowed barcode types for patient ID(436) In this section Patient entry type(427) Patient entry keyboard type(428) This configuration item specifies the available interfaces with which a patient ID is entered. Combinations of interfaces can be configured (e.g., Barcode and Keyboard, or Keyboard and RFID). i When the Patient entry type configuration item has no value the configuration is rejected. Item ID PATIENT_ID_ENTRY_TYPE Available values/format Barcode (default)
[BARCODE]
Patient ID is entered using a barcode scan. Keyboard (default)
[KEYBOARD]
RFID
[RFID]
Patient ID is entered using the virtual keyboard. Patient ID is entered using an RFID tag. Dependencies Barcode Patient ID pattern validation (barcode) Allowed barcode types for patient ID Checksum validation of barcode type
"Interleaved 2 of 5"
n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 428 Patient ID handling Minimum barcode scanning time Patient entry keyboard type Patient ID pattern validation (keyboard) Keyboard:
RFID Patient ID pattern validation (RFID) Patient RFID tag record configuration Configuration You configure the Patient entry type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient entry keyboard type (428) Patient RFID tag record configuration (475) Patient entry keyboard type This configuration item specifies if an alphanumeric or a numeric keyboard is used to enter a patient ID. Item ID PATIENT_ID_ENTRY_KB Available values/format Alphanumeric keyboard (default)
[ALPHANUMERIC]
Numeric keyboard
[NUMERIC]
Dependencies The Patient entry type configuration item has a value of Keyboard. Configuration You configure the Patient entry keyboard type configuration item using the following methods:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient entry type (427) Patient ID validation Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 Patient ID validation Item ID PATIENT_ID_VALIDATION Available values/format Pattern-based (default) General configuration 429 In this section Patient ID validation(429) Patient ID pattern validation (keyboard)(430) Patient ID pattern validation (barcode)(431) Patient ID pattern validation (RFID)(433) This configuration item specifies how a patient ID is validated when entered.
[PATTERN_BASED_ONLY]
The patient ID entered is validated against the pattern defined by the corresponding configuration item. Patient ID pattern validation (keyboard) Patient ID pattern validation (barcode) Patient ID pattern validation (RFID) List-based
[LIST_BASED]
The patient ID entered is validated in the same way as with the Pattern-based value. It is also validated against a patient list which has been provided by the DMS. List-based (allow unknown patient IDs)
[LIST_BASED_ALLOW_NEW_ENTRIES_IF_NOT_IN_LI ST]
The patient ID entered is validated in the same way as with the Pattern-based value. It is also validated against a patient list which has been provided by the DMS.However, if the patient ID is not found in the instruments patient list, and it is successfully validated against the pattern defined by the corresponding configuration item, the user may still run the test for the patient and record the result. n o i t a r u g i f n o c l a r e n e G 1 1 Dependencies For cobas infinity edge only, Pattern-based is the is the only valid value. For cobas infinity edge and a DMS, if the DMS supports patient lists, List-based and List-based
(allow unknown patient IDs) are valid values. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 430 Patient ID handling Patient ID pattern validation (keyboard) The Patient ID validation configuration works in conjunction with the following configuration items:
Patient ID pattern validation (keyboard) Patient ID pattern validation (barcode) Patient ID pattern validation (RFID) These configuration items specify the pattern used to validate a patient ID entered by the corresponding methods (keyboard, barcode scan, RFID tag). Configuration You configure the Patient ID validation configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient ID pattern validation (keyboard) (430) Patient ID pattern validation (barcode) (431) Patient ID pattern validation (RFID) (433) Item ID PATIENT_ID_PATTERN_KB Available values/format ST:0-500 (regular expression) This configuration item specifies the expression used to validate a patient ID entered using the keyboard. A regular expression is used to validate character/
number patterns, minimum length, and maximum length with the following:
Validate the input and use it completely as an ID. This configuration item can contain Unicode characters. No default value set. Example:
Input checked for pattern and completely used as ID Regular expression: PA\d{1,5}
Input: "PA123"
Extracted ID: "PA123"
The input PA123456789 violates the given regular expression and will not be accepted as a valid patient ID. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 General configuration 431 Dependencies The Patient entry type configuration item must have a value of Keyboard. Configuration You configure the Patient ID pattern validation
(keyboard) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient ID validation (429) Patient entry type (427) Patient ID pattern validation (barcode) This configuration item specifies the expression used to validate a patient ID entered using a barcode scan. A regular expression is used to validate character/
number patterns, minimum length, and maximum length with the following options:
Validate the input and use it completely as an ID. Validate the input, extract and use one substring of the input as the ID. Validate the input, extract and use multiple substrings of the input as the ID in a concatenated manner. The following logic is applied during the processing of patterns:
If the pattern does not contain a group, the complete content of the barcode needs to match and is used as the corresponding ID. In order to validate an incoming string and use multiple parts of it concatenated as the ID, the regular expression must use named groups surrounding the parts that should be concatenated as the ID. The name of the groups must have the format
"<id<index>>" with the index being a digit 0-9 (e.g.,
<id1>). The extracted content of the groups will be concatenated in the order sorted by the index. In this case, the regular expression is used for validating the format of the entire input as well as extracting multiple parts of it. Based on the group name with the index, the extracted substrings are concatenated in the business logic of the Glucose app. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 432 Patient ID handling Item ID PATIENT_ID_PATTERN_BCS Available values/format ST:0-500 (regular expression) Regular expressions are checked by the Glucose app for correct regex syntax only. If the stated (project specific) format "id<index>" is not correctly used, the regex will be saved in the database, but will not result in the intended behavior. Example of regex with two groups:
(?<id1>[A-Z]{3}).(?<id2>[A-Z]{3})\$
This configuration item can contain wide characters. No default value set. Examples:
Example 1:
Input checked for pattern and completely used as ID Regular expression: PA\d{1,5}
Input: "PA123"
Extracted ID: "PA123"
Example 2:
Part of input used as ID Regular expression: (PA\d{1,5}).*
Input: "PA321;Max Mustermann;1970-01-01"
Extracted ID: "PA321"
Example 3:
Multiple parts of input used as ID Regular expression: (?<id0>[A-Z]{3})x(?<id1>[A-Z]
{3})\$
Input: "ABCxDEF$"
Extracted ID: "ABCDEF"
Example 4:
Multiple parts of input used as ID in a different order Regular expression: (?<id1>[A-Z]{3})x(?<id0>[A-Z]
{3})\$
Input: "ABCxDEF$"
Extracted ID: "DEFABC"
Example 5:
Extract the ID between first occurrence of $ and first occurrence of +. The ID must start with one alpha character (A-Z/a-z), followed by seven numbers
(0-9). Regex with one group: .*\$([a-zA-Z]\d{7})\+.*
Input: ~Jane Doe%$X1234567+5715486266Z?
01-09-1979 Extracted ID: "X1234567"
Example 6:
Extract the ID between 3rd and 4th semicolon (; =
0x3b). Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 Patient ID pattern validation (RFID) General configuration 433 Input: ;Mary Miller;;X1234321;5715486266Z;01-09-1982 Regex with one group: [^\;]*\;[^\;]*\;[^\;]*\;([^\;]*)\;
Extracted ID: "X1234321"
Dependencies The Patient entry type configuration item must have a value of Barcode. Configuration You configure the Patient ID pattern validation
(barcode) configuration item item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient ID validation (429) Patient entry type (427) This configuration item specifies the expression used to validate a patient ID entered using an RFID tag. A regular expression is used to validate character/
number patterns, minimum length, and maximum length with the following options:
Validate the input and use it completely as an ID. Validate the input, extract and use one substring of the input as the ID. Validate the input, extract and use multiple substrings of the input as the ID in a concatenated manner. The following logic is applied during the processing of patterns:
If the pattern does not contain a group, the complete content of the barcode needs to match and is used as the corresponding ID. In order to validate an incoming string and use multiple parts of it concatenated as the ID, the regular expression must use named groups surrounding the parts that should be concatenated as the ID. The name of the groups must have the format
"<id<index>>" with the index being a digit 0-9 (e.g.,
<id1>). The extracted content of the groups will be concatenated in the order sorted by the index. In this case, the regular expression is used for validating the format of the entire input as well as extracting multiple parts of it. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 434 Patient ID handling Based on the group name with the index, the extracted substrings are concatenated in the business logic of the Glucose app. Regular expressions are checked by the Glucose app for correct regex syntax only. If the stated (project specific) format "id<index>" is not correctly used, the regex will be saved in the database, but will not result in the intended behavior. Example of regex with two groups:
(?<id1>[A-Z]{3}).(?<id2>[A-Z]{3})\$
This configuration item can contain Unicode characters. Item ID PATIENT_ID_PATTERN_RFID Available values/format ST:0-500 (regular expression) No default value set. Dependencies The Patient entry type configuration item must have a value of RFID. Configuration You configure the Patient ID pattern validation
(RFID) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient ID validation (429) Patient entry type (427) n o i t a r u g i f n o c l a r e n e G 1 1 Patient ID confirmation dialog This configuration item specifies whether or not the user must confirm that the correct patient ID has been entered when performing a patient test. Confirmation is made using the Confirm patient dialog box which contains the patient details which are present in the patient list received from the DMS. The patient details can contain:
Patient name Patient ID Gender Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 435 Age Date of birth Depending on the capabilities of the DMS and the available data, only a subset of the listed patient details might be available and displayed. Item ID PATIENT_ID_CONFIRMATION Available values/format Enabled (default) The Confirm patient dialog box is displayed.
[true]
Disabled
[false]
The Confirm patient dialog box is not displayed. Configuration You configure the Patient ID confirmation dialog configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item specifies whether or not the patient ID autocomplete function is enabled for patient ID entry by keyboard. When patient ID autocomplete is enabled, after entering 2 alphanumeric characters, all patient names or IDs containing the same 2 alphanumeric character sequence are displayed in a drop-down list. The patient is selected from the drop-down list. Item ID PATIENT_ID_AUTO_COMPLETE Available values/format Disabled (default) Patient ID autocomplete is not enabled.
[false]
Enabled
[true]
Patient ID autocomplete is enabled. Dependencies The Patient ID validation configuration item must have either the following values:
List-based List-based (allow unknown patient IDs) n o i t a r u g i f n o c l a r e n e G 1 1 Patient ID autocomplete Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 436 Patient ID handling Configuration You configure the Patient ID autocomplete configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Allowed barcode types for patient ID This configuration item specifies the barcode symbologies that are valid for reading patient IDs. All barcodes with a different symbology to the ones listed below are invalid and not processed. Item ID BCS_PATIENT_ID Available values/format Aztec code Code 128 (default)
[AZTEC]
Codabar
[CODABAR]
[CODE128]
Code 39
[CODE39]
Code 93
[CODE93]
Data matrix (default)
[DATA_MATRIX]
EAN-13
[EAN13]
GS1 DataBar
[GS1_DATABAR_LIMITED]
Interleaved 2 of 5
[INTERLEAVED_2_OF_5]
PDF417
[PDF417]
QR code
[QR]
n o i t a r u g i f n o c l a r e n e G 1 1 Configuration You configure the Allowed barcode types for patient ID configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 437 User ID handling User ID entry interfaces In this section User ID entry interfaces(437) User ID validation(439) User ID handling(444) Allowed barcode types for user ID(447) In this section User authentication required(437) User authentication type(438) User authentication keyboard type(439) User authentication required This configuration item specifies when a user must enter their user ID and, depending on the configuration, their password to use the Glucose app. Item ID OPERATOR_ID_ENTRY Available values/format Disabled (default)
[NONE]
No user ID and password is required to use the Glucose app. Enabled for QC test only
[QC_ONLY]
A user must enter their ID and password to be able to perform a QC test. Enabled
[ALWAYS]
A user ID and password is required to use the Glucose app. Dependencies User authentication type configuration item. Regulatory region configuration item. Configuration You configure the User authentication required configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 438 User ID handling User authentication type Item ID OPERATOR_ID_ENTRY_TYPE Available values/format Barcode (default) Dependencies For Keyboard:
This configuration item specifies the available interfaces with which a user ID is entered. Combinations of interfaces can be configured (e.g., "barcode and keyboard" or "keyboard and RFID"). i When the User authentication required configuration item has no value the configuration is rejected. The user ID is entered using the barcode scan. The user ID is entered using the virtual keyboard.
[BARCODE]
Keyboard (default)
[KEYBOARD]
RFID
[RFID]
The user ID entered using an RFID tag. User authentication keyboard type User ID pattern validation (keyboard) For Barcode:
User ID pattern validation (barcode) Allowed barcode types for user ID Checksum validation of barcode type
"Interleaved 2 of 5"
Minimum barcode scanning time For RFID:
User ID pattern validation (RFID) User RFID tag record configuration Configuration You configure the User authentication type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics User authentication keyboard type (439) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 439 User authentication keyboard type This configuration item specifies if an alphanumeric or a numeric keyboard is used to enter the user ID. Item ID OPERATOR_ID_ENTRY_KB Available values/format Alphanumeric keyboard (default)
[ALPHANUMERIC]
User authentication keyboard type
[NUMERIC]
Dependencies The User authentication required configuration item has a value of Keyboard. Configuration You configure the User authentication keyboard type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics User authentication type (438) User ID validation User ID validation In this section User ID validation(439) User ID pattern validation (keyboard)(440) User ID pattern validation (barcode)(441) User ID pattern validation (RFID)(443) This configuration item specifies how a user ID is validated when entered. Item ID OPERATOR_ID_VALIDATION Available values/format Pattern-based (default)
[PATTERN_BASED_ONLY]
The user ID entered is validated against the pattern defined by the corresponding configuration item:
User ID pattern validation (keyboard) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 440 User ID handling Dependencies For cobas infinity edge only, Pattern-based is the only valid value. User ID pattern validation (barcode) User ID pattern validation (RFID) List-based
[LIST_BASED]
The user ID entered is validated in the same way as with the Pattern-based value. It is also validated against a user list that is stored on the instrument. List-based with password
[LIST_BASED_WITH_PASSWORD]
The user ID entered is validated in the same way as with the Pattern-based value. It is also validated against a user and password list that is stored on the instrument. For cobas infinity edge and a DMS, if the DMS supports patient lists, List-based and List-based with password are valid values. User ID validation works in conjunction with the following configuration items:
User ID pattern validation (keyboard) User ID pattern validation (barcode) User ID pattern validation (RFID) These configuration items specify the pattern used to validate a user ID entered by the corresponding methods
(keyboard, barcode scan, RFID tag). Configuration You configure the User ID validation configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics User ID pattern validation (keyboard) (440) User ID pattern validation (barcode) (441) User ID pattern validation (RFID) (443) n o i t a r u g i f n o c l a r e n e G 1 1 User ID pattern validation (keyboard) This configuration item specifies the expression used to validate a user ID entered using the keyboard. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 441 A regular expression is used to validate character/
number patterns, minimum length, and maximum length with the following:
Validate the input and use it completely as an ID. This configuration item can contain Unicode characters. Item ID OPERATOR_ID_PATTERN_KB Available values/format ST:0-500 (regular expression) No default value set. Example:
Input checked for pattern and completely used as ID Regular expression: OP\d{1,5}
Input: "OP123"
Extracted ID: "OP123"
The input PA123456789 violates the given regular expression and will not be accepted as a valid patient ID. Dependencies The User authentication required configuration item must have a value of Keyboard. Configuration You configure the User ID pattern validation
(keyboard) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics User ID validation (439) User authentication type (438) n o i t a r u g i f n o c l a r e n e G 1 1 This configuration item specifies the expression used to validate an user ID entered using barcode scan. A regular expression is used to validate character/
number patterns, minimum length, and maximum length with the following options:
Validate the input and use it completely as an ID. Validate the input, extract and use one substring of the input as the ID. User ID pattern validation (barcode) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 442 User ID handling Validate the input, extract and use multiple substrings of the input as the ID in a concatenated manner. The following logic is applied during the processing of patterns:
If the pattern does not contain a group, the complete content of the barcode needs to match and is used as the corresponding ID. In order to validate an incoming string and use multiple parts of it concatenated as the ID, the regular expression must use named groups surrounding the parts that should be concatenated as the ID. The name of the groups must have the format
"<id<index>>" with the index being a digit 0-9 (e.g.,
<id1>). The extracted content of the groups will be concatenated in the order sorted by the index. In this case, the regular expression is used for validating the format of the entire input as well as extracting multiple parts of it. Based on the group name with the index, the extracted substrings are concatenated in the business logic of the Glucose app. Regular expressions are checked by the Glucose app for correct regex syntax only. If the stated (project specific) format "id<index>" is not correctly used, the regex will be saved in the database, but will not result in the intended behavior. Example of regex with two groups:
(?<id1>[A-Z]{3}).(?<id2>[A-Z]{3})\$
This configuration item can contain Unicode characters. n o i t a r u g i f n o c l a r e n e G 1 1 Item ID OPERATOR_ID_PATTERN_BCS Available values/format ST:0-500 (regular expression) No default value set. Dependencies The User authentication required configuration item must have a value of Barcode. Configuration You configure the User ID pattern validation
(barcode) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 User ID pattern validation (RFID) General configuration 443 u Related topics User ID validation (439) User authentication type (438) This configuration item specifies the expression used to validate an user ID entered using an RFID tag. A regular expression is used to validate character/
number patterns, minimum length, and maximum length with the following options:
Validate the input and use it completely as an ID. Validate the input, extract and use one substring of the input as the ID. Validate the input, extract and use multiple substrings of the input as the ID in a concatenated manner. The following logic is applied during the processing of patterns:
If the pattern does not contain a group, the complete content of the barcode needs to match and is used as the corresponding ID. In order to validate an incoming string and use multiple parts of it concatenated as the ID, the regular expression must use named groups surrounding the parts that should be concatenated as the ID. The name of the groups must have the format
"<id<index>>" with the index being a digit 0-9 (e.g.,
<id1>). The extracted content of the groups will be concatenated in the order sorted by the index. In this case, the regular expression is used for validating the format of the entire input as well as extracting multiple parts of it. Based on the group name with the index, the extracted substrings are concatenated in the business logic of the Glucose app. Regular expressions are checked by the Glucose app for correct regex syntax only. If the stated (project specific) format "id<index>" is not correctly used, the regex will be saved in the database, but will not result in the intended behavior. Example of regex with two groups:
(?<id1>[A-Z]{3}).(?<id2>[A-Z]{3})\$
This configuration item can contain Unicode characters. The User authentication type configuration item must have a value of RFID. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 444 User ID handling Item ID OPERATOR_ID_PATTERN_RFID Available values/format ST:0-500 (regular expression) No default value set. Configuration You configure the User ID pattern validation (RFID) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics User ID validation (439) User authentication type (438) User ID handling Minimum password length In this section Minimum password length(444) Logon session timeout(445) Show user lockout warning prior to user certificate expiration(445) User ID autocomplete(446) This configuration item specifies the minimum length
(characters) of a new password which is validated by the instrument when entered by a user. Item ID MINIMAL_PASSWORD_LENGTH Available values/format 4 - 20 characters Default = 4 characters Dependencies The Minimum password length configuration item is only relevant when the following 2 conditions are true:
The User authentication required configuration item has a value of Enabled or Enabled for QC test only. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 General configuration 445 The User ID validation configuration item has a value of List-based with password. Configuration You configure the Minimum password length configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Logon session timeout This configuration item specifies the length of time
(seconds) that a user ID remains logged on after the instrument has gone into standby mode. A user ID and password must be entered after this period of time has elapsed. Item ID OPERATOR_INACTIVITY_TIMEOUT Available values/format 0 - 3600 seconds Default = 0 seconds Dependencies The Logon session timeout configuration item is only relevant when user lists are used (User authentication required has a value of Enabled for QC test only or Enabled. Configuration You configure the Logon session timeout configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Show user lockout warning prior to user certificate expiration This configuration item specifies the time in days before an expired user certificate warning is displayed. Item ID CERTIFICATION_EXPIRATION_WARNING_IN_DAYS Available values/format 0 - 90 days Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 446 User ID handling User ID autocomplete Default = 0 days Dependencies The Show user lockout warning prior to user certificate expiration configuration item is only relevant when user lists are used (User authentication required has a value of Enabled for QC test only or Enabled). Configuration You configure the Show user lockout warning prior to user certificate expiration configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item specifies whether or not user ID autocomplete is enabled for user ID entry by keyboard. When user ID autocomplete is enabled, after entering 2 alphanumeric characters, all user names or IDs containing the same 2 alphanumeric character sequence are displayed in a drop-down list. Item ID OPERATOR_ID_AUTO_COMPLETE Available values/format Disabled (default) User ID autocomplete is disabled.
[false]
Enabled
[true]
User ID autocomplete is enabled. Dependencies The User ID autocomplete configuration item is only relevant when user lists are used (User authentication required has a value of Enabled for QC test only or Enabled). Configuration You configure the User ID autocomplete configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 447 Allowed barcode types for user ID This configuration item specifies the barcode symbologies that are valid for entering user IDs. If a symbology used is not listed below, the code scanned is invalid and will not be processed. Item ID BCS_OPERATOR_ID Available values/format Aztec code Code 128 (default)
[AZTEC]
Codabar
[CODABAR]
[CODE128]
Code 39
[CODE39]
Code 93
[CODE93]
Data matrix (default)
[DATA_MATRIX]
EAN-13
[EAN13]
GS1 DataBar
[GS1_DATABAR_LIMITED]
Interleaved 2 of 5
[INTERLEAVED_2_OF_5]
PDF417
[PDF417]
QR code
[QR]
Configuration You configure the Allowed barcode types for user ID configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 448 Result range handling Result range handling In this section Normal range lower limit(448) Normal range upper limit(449) Critical range lower limit(449) Critical range upper limit(450) Reportable range lower limit(451) Reportable range upper limit(451) Message displayed if the result is below the reportable range(452) Custom message (below reportable range)(453) Message displayed if the result is above the reportable range(454) Custom message (above reportable range)(454) Custom message (above critical range)(455) Custom message (below critical range)(456) Message displayed if the result is above the critical range(456) Message displayed if the result is below the critical range(457) This configuration item specifies the value of the lower limit of the normal range for glucose test results. It is expressed in mg/dL or mmol/L. The default value is set by the Glucose app based on the Result unit (glucose tests) configuration item. Normal range lower limit n o i t a r u g i f n o c l a r e n e G 1 1 Item ID NORMAL_RANGE_LO_LIMIT Available values/format Default values:
10 mg/dL 0.6 mmol/L Dependencies The following dependencies must be true:
The Normal range lower limit value must be less than the Normal range upper limit value. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 449 The Normal range lower limit value must be greater than or equal to the Critical range lower limit value. Configuration You configure the Normal range lower limit configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Normal range upper limit This configuration item specifies the value of the upper limit of the normal range for glucose test results. It is expressed in mg/dL or mmol/L. The default value is set by the Glucose app based on the Result unit (glucose tests) configuration item. Item ID NORMAL_RANGE_HI_LIMIT Available values/format Default values:
Dependencies The following dependencies must be true:
600 mg/dL 33.3 mmol/L The Normal range upper limit value must be greater than the Normal range lower limit value. The Normal range upper limit value must be less than or equal to the Critical range upper limit value. Configuration You configure the Normal range upper limit configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Critical range lower limit This configuration item specifies the value of the lower limit of the critical range for glucose test results. It is expressed in mg/dL or mmol/L. The default value is set by the Glucose app based on the Result unit (glucose tests) configuration item. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 450 Result range handling Item ID CRITICAL_RANGE_LO_LIMIT Available values/format Default values:
10 mg/dL 0.6 mmol/L Dependencies The following dependencies must be true:
Configuration Critical range upper limit The Critical range lower limit value must be greater than or equal to the Reportable range lower limit value. The Critical range lower limit value must be less than or equal to the Normal range lower limit value. You configure the Critical range lower limit configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics range (457) Message displayed if the result is below the critical This configuration item specifies the value of the upper limit of the critical range for glucose test results. It is expressed in mg/dL or mmol/L. The default value is set by the Glucose app based on the Result unit (glucose tests) configuration item. n o i t a r u g i f n o c l a r e n e G 1 1 Item ID CRITICAL_RANGE_HI_LIMIT Available values/format Default values:
600 mg/dL 33.3 mmol/L Dependencies The following dependencies must be true:
The Critical range upper limit value must be greater than or equal to the Normal range upper limit value. The Critical range upper limit value must be less than or equal to the Reportable range upper limit value. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 451 Configuration You configure the Critical range upper limit configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics range (456) Message displayed if the result is above the critical Reportable range lower limit This configuration item specifies the value of the lower limit of the reportable range for glucose test results. It is expressed in mg/dL or mmol/L. The default value is set by the Glucose app based on the Result unit (glucose tests) configuration item. Item ID REPORTABLE_RANGE_LO_LIMIT Available values/format Default values:
10 mg/dL 0.6 mmol/L Dependencies The Reportable range lower limit value must be less than or equal to the Critical range lower limit value. Configuration You configure the Reportable range lower limit configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Message displayed if the result is below the reportable range (452) Reportable range upper limit This configuration item specifies the value of the upper limit of the reportable range for glucose test results. It is expressed in mg/dL or mmol/L. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 452 Result range handling The default value is set by the Glucose app based on the Result unit (glucose tests) configuration item. Item ID REPORTABLE_RANGE_HI_LIMIT Available values/format Default values:
600 mg/dL 33.3 mmol/L Dependencies The Reportable range upper limit value must be greater than or equal to the Critical range upper limit value. Configuration You configure the Reportable range upper limit configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Message displayed if the result is above the reportable range (454) Message displayed if the result is below the reportable range This configuration item determines if the "below reportable range message" is displayed when a glucose test result value is below the reportable range. The content of the custom message is entered using the Custom message (below reportable range) configuration item. If a custom message has not been configured, a built-in message is displayed when the value for this configuration item is Enabled. Item ID DISPLAY_REPORTABLE_RANGE_LO_MESSAGE Available values/format Disabled (default) The message is not displayed.
[false]
Enabled
[true]
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 Custom message (below reportable range) General configuration 453 Configuration The message is displayed. You configure the Message displayed if the result is below the reportable range configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Custom message (below reportable range) (453) Reportable range lower limit (451) You use this configuration item to create the content of the below reportable range message. The message is displayed when the following conditions are true:
The glucose test result is less than the value set in the Reportable range lower limit configuration item. The Message displayed if the result is below the reportable range configuration item has a value of Enabled. Item ID BELOW_REPORTABLE_RANGE_LO_MESSAGE Available values/format The message can contain a maximum of 100 alphanumeric characters. If this configuration item is left empty a built-in message is displayed. Configuration You configure the Custom message (below reportable range) configuration item using the following:
Data management system (e.g., cobas infinity POC) u Related topics Reportable range lower limit (451) Message displayed if the result is below the reportable range (452) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 454 Result range handling Message displayed if the result is above the reportable range This configuration item determines if the "above reportable range message" is displayed when a glucose test result value is above the reportable range. The content of the custom message is entered using the Custom message (above reportable range) configuration item. If a custom message has not been configured, a built-in message is displayed when the value for this configuration item is Enabled. Item ID DISPLAY_REPORTABLE_RANGE_HI_MESSAGE Available values/format Disabled (default) The message is not displayed.
[false]
Enabled
[true]
The message is displayed. Configuration You configure the Message displayed if the result is above the reportable range configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Custom message (above reportable range) (454) Reportable range upper limit (451) n o i t a r u g i f n o c l a r e n e G 1 1 Custom message (above reportable range) You use this configuration item to create the content of the above reportable range message. The message is displayed when the following conditions are true:
The glucose test result is greater than the value set in the Reportable range upper limit configuration item. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 455 The Message displayed if the result is above the reportable range configuration item has a value of Enabled. Item ID ABOVE_REPORTABLE_RANGE_HI_MESSAGE Available values/format The message can contain a maximum of 100 alphanumeric characters. If this configuration item is left empty a built-in message is displayed. Configuration You configure the Custom message (above reportable range) configuration item using the following:
Data management system (e.g., cobas infinity POC) u Related topics Message displayed if the result is above the reportable range (454) Reportable range upper limit (451) You use this configuration item to create the content of the above critical range message. The message is displayed when the following conditions are true:
The glucose test result is greater than the value set in the Critical range upper limit configuration item. The Message displayed if the result is above the critical range configuration item has a value of Enabled. Item ID ABOVE_CRITICAL_RANGE_HI_MESSAGE Available values/format The message can contain a maximum of 100 alphanumeric characters. If this configuration item is left empty a built-in message is displayed. Configuration You configure the Custom message (above critical range) configuration item using the following:
Data management system (e.g., cobas infinity POC) n o i t a r u g i f n o c l a r e n e G 1 1 Custom message (above critical range) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 456 Result range handling Custom message (below critical range) You use this configuration item to create the content of the below critical range message. The message is displayed when the following conditions are true:
The glucose test result is less than the value set in the Critical range lower limit configuration item. The Message displayed if the result is below the critical range configuration item has a value of Enabled. Item ID BELOW_CRITICAL_RANGE_LO_MESSAGE Available values/format The message can contain a maximum of 100 alphanumeric characters. If this configuration item is left empty a built-in message is displayed. Configuration You configure the Custom message (below critical range) configuration item using the following:
Data management system (e.g., cobas infinity POC) Message displayed if the result is above the critical range This configuration item determines if the "above critical range message" is displayed when a glucose test result value is above the critical range. The content of the custom message is entered using the Custom message (above critical range) configuration item. If a custom message has not been configured, a built-in message is displayed when the value for this configuration item is Enabled. Item ID DISPLAY_CRITICAL_RANGE_HI_MESSAGE Available values/format Disabled (default) The message is not displayed.
[false]
Enabled
[true]
The message is displayed. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 Message displayed if the result is below the critical range General configuration 457 Configuration You configure the Message displayed if the result is above the critical range configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Critical range upper limit (450) Custom message (above critical range) (455) This configuration item determines if the "below critical range message" is displayed when a glucose test result value is below the critical range. The content of the custom message is entered using the Custom message (below critical range) configuration item. If a custom message has not been configured, a built-in message is displayed when the value for this configuration item is Enabled. Item ID DISPLAY_CRITICAL_RANGE_LO_MESSAGE Available values/format Disabled (default) The message is not displayed.
[false]
Enabled
[true]
The message is displayed. Configuration You configure the Message displayed if the result is below the critical range configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Custom message (below critical range) (456) Critical range lower limit (449) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 458 Measurement workflow Measurement workflow Emergency workflow Allow emergency tests In this section Emergency workflow(458) Test strip ejection(459) Sample type(460) Result unit (glucose tests)(460) Configure override QC(461) Comment management(462) In this section Allow emergency tests(458) Default patient ID for emergency tests(459) This configuration item enables or disables the emergency workflow. When enabled, the Emergency button is accessible on the Tests screen. The emergency workflow allows a glucose test to be performed without patient identification. n o i t a r u g i f n o c l a r e n e G 1 1 Item ID EMERGENCY_WORKFLOW Available values/format Disabled (default) Emergency workflow is disabled.
[false]
Enabled
[true]
Emergency workflow is enabled. Dependencies The Allow emergency tests configuration item works in conjunction with the Default patient ID for emergency tests configuration item which provides the patient ID used in an emergency workflow. Configuration You configure the Allow emergency tests configuration item using the following:
Data management system (e.g., cobas infinity POC) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 459 Barcode (generated via cobas infinity edge) u Related topics Default patient ID for emergency tests (459) This configuration item specifies the ID that is used as the patient ID for emergency glucose tests. Default patient ID for emergency tests Item ID EMERGENCY_ID Available values/format 1-20 alphanumeric characters
"99999999" (default) Dependencies The Allow emergency tests configuration item has the value Enabled. Configuration You configure the Default patient ID for emergency tests configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Allow emergency tests (458) Test strip ejection This configuration item specifies at which point in the glucose test workflow the user ejects a used test strip. Item ID STRIP_EJECT_CONFIGURATION Available values/format After test result conrmation (default)
[AFTER_RESULT_CONFIRMATION]
Test strip is ejected after the test result confirmation. Before test result conrmation
[BEFORE_RESULT_CONFIRMATION]
Test strip is ejected before the test result confirmation. Configuration You configure the Test strip ejection configuration item using the following:
Data management system (e.g., cobas infinity POC) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 460 Measurement workflow Sample type Barcode (generated via cobas infinity edge) This configuration item specifies the available sample types that can be displayed to the user when performing a glucose test. The Sample type configuration item is used to indicate the source of the blood sample. If it has no value
(default), the sample type selection screen is not displayed. When the configuration item contains values, the sample type selection screen is displayed listing the corresponding sample types. Item ID SAMPLE_TYPE_SELECTION Available values/format Capillary blood
[CAPILLARY]
Venous blood
[VENOUS]
Arterial blood
[ARTERIAL]
Heel-stick blood
[HEEL_STICK]
"No value" (default) Configuration You configure the Sample type configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Result unit (glucose tests) This configuration item specifies measurement unit used in glucose test results. If the result unit is changed, the instrument deletes all stored results and resets all configured measurement range values to their default values. You must ensure that all unsent results are retrieved from the instrument before changing the value of this configuration item. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 General configuration 461 Item ID RESULT_UNIT_GLUCOSE Available values/format mmol/L (default)
[MMOL_PER_LITER]
mg/dL
[MG_PER_DECILITER]
Dependencies If the result unit has been automatically set as a result of a change of the Regulatory region configuration item, this configuration item cannot be changed. Configuration You configure the Result unit (glucose tests) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Regulatory region (374) Configure override QC In this section Allow QC / synchronization lockout overrides(461) Number of lockout overrides allowed(462) Allow QC / synchronization lockout overrides This configuration item enables or disables the override QC / synchronization lockout function. Item ID STAT_TESTS Available values/format Disabled (default) Dependencies Override function is disabled.
[false]
Enabled
[true]
Override function is enabled. The Number of lockout overrides allowed configuration item specifies the maximum number of tests that can be overridden. When the Regulatory region configuration item has a value of US, Allow QC / synchronization lockout overrides is disabled and cannot be enabled. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 462 Measurement workflow Configuration You configure the Allow QC / synchronization lockout overrides configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Number of lockout overrides allowed (462) Number of lockout overrides allowed This configuration item specifies the number of lockout overrides that are permitted before a QC test or synchronization must be performed. Item ID STAT_TESTS_NUMBER Available values/format 1-9 overrides Default = 9 overrides Dependencies The Allow QC / synchronization lockout overrides configuration item must have a value of Enabled. Configuration You configure the Number of lockout overrides allowed configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Allow QC / synchronization lockout overrides (461) In this section Allow user-defined comments(463) Condition for required comments on patient results(464) Allow comments on patient results(464) Allow comments on QC results(465) Comment management n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 463 Allow user-defined comments Item ID CUSTOM_COMMENTS Available values/format Enabled (default) Dependencies This configuration item specifies whether or not custom comments can be made. Custom comments enable free-text comments to be added on the Comments screen. Custom comments is enabled.
[true]
Disabled
[false]
Custom comments is disabled. The Allow user-defined comments configuration item is only relevant when comments are enabled for patient and QC tests as follows:
If the Allow comments on patient results configuration item has one of the following values:
Required when below or above selected Optional range Always required If the Allow comments on QC results configuration item has one of the following values:
Optional Required when QC fails Always required Configuration You configure the Allow user-defined comments configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Allow comments on patient results (464) Allow comments on QC results (465) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 464 Measurement workflow Condition for required comments on patient results This configuration item specifies when comments must be added to a patient result, based on the result range into which a patient test result falls. Item ID COMMENTS_REQUIRED_LEVEL_PATIENT_TESTING Available values/format Below/above normal range (default)
[REQUIRED_IF_OUT_OF_NORMAL_RANGE]
A comment is required when the patient result is above or below the normal range. Below/above critical range
[REQUIRED_IF_OUT_OF_CRITICAL_RANGE]
A comment is required when the patient result is below critical range lower limit, or above critical range upper limit. Below/above reportable range
[REQUIRED_IF_OUT_OF_REPORTABLE_RANGE]
A comment is required when the patient result is below reportable range lower limit or above reportable range upper limit. Below/above measuring range
[REQUIRED_IF_OUT_OF_SYSTEM_MEASUREMENT_ RANGE]
A comment is required when the patient result is outside the measuring range. The Condition for required comments on patient results configuration item is only relevant when the Allow comments on patient results configuration item has a value of Required when below or above selected range. You configure the Condition for required comments on patient results configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Allow comments on patient results (464) This configuration item determines comment handling for patient tests. Dependencies Configuration n o i t a r u g i f n o c l a r e n e G 1 1 Allow comments on patient results Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 465 Item ID COMMENTS_REQUIRED_PATIENT_TESTING Available values/format Optional (default)
[OPTIONAL]
Dependencies Configuration Comment entry is optional for patient tests. Required when below or above selected range
[OUT_OF_RANGE]
Comment entry is mandatory when a patient test result falls outside a specified range. Always required
[REQUIRED]
Disabled
[DISABLED]
Comment entry is mandatory for all patient tests. Comment entry is disabled for patient tests. The Allow comments on patient results configuration item works in conjunction with the following configuration items:
Allow user-defined comments Condition for required comments on patient results You configure the Allow comments on patient results configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Allow user-defined comments (463) Condition for required comments on patient results
(464) This configuration item determines comment handling for QC tests. n o i t a r u g i f n o c l a r e n e G 1 1 Allow comments on QC results Item ID COMMENTS_REQUIRED_QC_TESTING Available values/format Optional (default)
[OPTIONAL]
Comment entry is optional for QC tests. Required when QC fails
[FAILED_QC]
Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 466 Measurement workflow Comment entry is mandatory when a QC test fails. Always required
[REQUIRED]
Disabled
[DISABLED]
Comment entry is mandatory for all QC tests. Comment entry is disabled for QC tests. Dependencies The Allow comments on patient results configuration item works in conjunction with the Allow user-defined comments configuration item. Configuration You configure the Allow comments on QC results configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Allow user-defined comments (463) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Generic instrument functionality Access restrictions Instrument settings password General configuration 467 In this section Access restrictions(467) Lot management(471) RFID tag(474) Tests menu(476) Cleaning(479) Instrument site, location, and name(473) In this section Instrument settings password(467) Allow configuration by barcode on the instrument(468) Access restrictions to date and time(469) Allow access to administrator features(470) Allow access to lot management on the instrument(471) Depending on the configuration options outlined in the
"About the Settings menu access restrictions" section, you can use the setup password to protect access to the following options in the Settings menu:
Date and time Configuration by barcode Lot management Administrator The Configuration by barcode option is used to scan configuration barcodes. The Date and time option enables the instrument date and time to be set. For security reasons, the instrument settings password is part of the initial configuration barcode. An Instrument settings password with no value is valid. If some instrument settings shall be protected with the setup password, it must be ensured that the setup password is set to a password that follows cybersecurity guidelines. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 468 Generic instrument functionality CAUTION!
Password protection Protecting instrument settings using the setup password. r Ensure that the password chosen adheres to your facilitys cybersecurity guidelines, u Strong password management (22) u About the Settings menu access restrictions (367) Item ID SETUP_PASSWORD Available options/values ST:0-20 No default value set Configuration You configure the Instrument settings password configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics
(468) Allow configuration by barcode on the instrument Access restrictions to date and time (469) Allow configuration by barcode on the instrument This configuration item determines access to the Settings > Configuration by barcode option in which you scan QR configuration barcodes. Item ID CONFIGURATION_QR_CODE_ACCESS Available values/format Disabled
[DISABLED]
Access to the Settings > Configuration by barcode option is deactivated. Enabled (no restrictions)
[UNLIMITED_ACCESS]
Anyone can access the Settings > Configuration by barcode option. Enabled (setup password required) (default)
[VIA_SETUP_PASSWORD]
n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 469 The instrument settings password must be entered in order to access the Settings > Configuration by barcode option. Enabled (corresponding user rights required)
[VIA_OPERATOR_PRIVILEGE]
Access to the Settings > Configuration by barcode option is only available to users with the required ("POCC") privilege. Configuration You configure the Allow configuration by barcode on the instrument configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Instrument settings password (467) Access restrictions to date and time This configuration item determines access to the Settings > Date and time option in which you set the instrument date and time. Item ID DATE_TIME_EDITING_ACCESS Available options/values Only via DMS
[VIA_DMS]
Setting the instrument date and time is only possible via DMS/POCT1-A. No restrictions (default)
[UNLIMITED_ACCESS]
Setup password required VIA_SETUP_PASSWORD The instrument date and time can be set by anyone. The Instrument settings password is required for setting the instrument date and time. Corresponding user rights required
[VIA_OPERATOR_PRIVILEGE]
The instrument date and time can only be set by a user with the required ("POCC") privilege. Dependencies The Access restrictions to date and time configuration item is only active when the Network Time Protocol (NTP) configuration item has a value of Disabled. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 470 Generic instrument functionality If the Network Time Protocol (NTP) configuration item has a value of Enabled, the Access restrictions to date and time configuration item is automatically disabled on the instrument user interface. Configuration You configure the Access restrictions to date and time configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Instrument settings password (467) Allow access to administrator features This configuration item determines access to the Settings > Administrator option. Item ID ADMIN_ACCESS Available options/values Disabled
[DISABLED]
Access to Settings > Administrator option is disabled. Enabled (no restrictions)
[UNLIMITED_ACCESS]
Anyone can access the Settings > Administrator option. Enabled (corresponding user rights required)
[VIA_OPERATOR_PRIVILEGE]
Access to the Settings > Administrator option is only available to users with the required ("POCC") privilege. Enabled (setup password required) (default)
[VIA_SETUP_PASSWORD]
The Instrument settings password is required to access the Settings > Administrator option. Configuration You configure the Allow access to administrator features configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 471 Allow access to lot management on the instrument This configuration item determines access to the Settings > Lot management option. Item ID LOT_MANAGEMENT_ACCESS Available options/values Disabled
[DISABLED]
Access to Settings > Lot management option is disabled. Lot management is only possible using cobas infinity edge and/or the DMS. Enabled (no restrictions)
[UNLIMITED_ACCESS]
Anyone can access the Settings > Lot management option. Enabled (setup password required) (default)
[VIA_SETUP_PASSWORD]
The Instrument settings password is required to access the Settings > Lot management option. Enabled (corresponding user rights required)
[VIA_OPERATOR_PRIVILEGE]
Access to the Settings > Lot management option is only available to users with the "POCC" privilege. Configuration You configure the Allow access to lot management on the instrument configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Lot management In this section Allow linearity lot selection from list(471) Allow QC lot selection from list(472) Allow linearity lot selection from list This configuration item determines how a user selects a linearity lot number. Either from a list or by barcode scan, or by barcode scan only. Item ID LINEARITY_LOT_SELECTION_BY_LIST Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 472 Generic instrument functionality Allow QC lot selection from list Available options/values Enabled (default) List selection activated. A linearity lot number can be selected from a list or by barcode scan.
[true]
Disabled
[false]
List selection deactivated. A linearity lot number can be selected by barcode scan only. Dependencies The Allow linearity lot selection from list configuration item is only relevant when the Allow linearity tests configuration item has a value of Enabled. Configuration You configure the Allow linearity lot selection from list configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Item ID QC_LOT_SELECTION_BY_LIST Available options/values Enabled (default) This configuration item determines how a user selects a QC lot number. Either from a list or by barcode scan, or by barcode only. The list can be activated and deactivated. List selection activated. A QC lot number can be selected from a list or by barcode scan.
[true]
Disabled
[false]
List selection deactivated. A QC lot number can be selected by barcode scan only. Configuration You configure the Allow QC lot selection from list configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 General configuration 473 Instrument site, location, and name In this section Site(473) Location(473) Device name(474) This configuration item assigns the name of the site at which the instrument is used. It is assigned by DMS or barcode. The site name is visible at the bottom of the Glucose screen and the charging screen, above the instrument location if set. It can contain wide characters. u About the charging screen (45) Site Location Item ID SITE Available options/values ST: 0-20 No default value set. Configuration You configure the Site configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Location (473) n o i t a r u g i f n o c l a r e n e G 1 1 This configuration item assigns the name of the location at which the instrument is used. It is assigned by DMS or barcode. The location name is visible at the bottom of the Glucose screen and the charging screen, below the instrument site if set. It can contain wide characters. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 474 Generic instrument functionality u About the charging screen (45) Item ID LOCATION Available options/values ST: 0-20 No default value set. Configuration You configure the Location configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Site (473) This configuration item assigns the name of the instrument. It is assigned by DMS or barcode. The name is visible at the top of the Glucose screen and the charging screen. It can contain wide characters. u About the charging screen (45) Item ID NAME Available options/values ST: 0-20 No default value set. Configuration You configure the Device name configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) In this section Patient RFID tag record configuration(475) User RFID tag record configuration(475) RFID tag configuration(476) Device name n o i t a r u g i f n o c l a r e n e G 1 1 RFID tag Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 475 Patient RFID tag record configuration User RFID tag record configuration This configuration item specifies the NDEF record number stored on the patient RFID tag. Item ID PATIENT_RFID_TAG_RECORD Available options/values INT: 0-99 A value of "0" indicates that the content of the first NDEF record is used for identification. Dependencies The Patient RFID tag record configuration configuration item is only relevant when the Patient entry type configuration item has a value of RFID. Configuration You configure the Patient RFID tag record configuration configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient entry type (427) This configuration item specifies the NDEF record number stored on the user RFID tag. Item ID OPERATOR_RFID_TAG_RECORD Available options/values INT: 0-99 A value of "0" indicates that the content of the first NDEF record is used for identification. Dependencies The User RFID tag record configuration configuration item is only relevant when the RFID tag configuration configuration item has a value of Stored NDEF record. Configuration You configure the User RFID tag record configuration configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics Patient entry type (427) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 476 Generic instrument functionality RFID tag configuration This configuration item specifies what is used for identification when using a RFID tag. Item ID RFID_TAG_CONFIGURATION Available options/values Unique RFID tag ID (default)
[UNIQUE_ID]
The unique ID of the tag is used (between 4 bytes to up to 11 bytes). Stored NDEF record
[NDEF_RECORD]
An NDEF record stored on the tag is used (the record number is configured using the User RFID tag record configuration configuration item). Dependencies The User authentication required configuration item has a value of RFID. Configuration You configure the RFID tag configuration configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Tests menu Patient test series n o i t a r u g i f n o c l a r e n e G 1 1 In this section Patient test series(476) Allow linearity tests(477) Allow proficiency tests(477) Insulin dose entry(478) Startup behavior of the instrument(478) Message of the day(479) This configuration item specifies if a patient test series can be performed (i.e., performing successive tests on the same patient). Item ID PATIENT_TEST_SERIES Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Allow linearity tests General configuration 477 Available values/format Disabled (default) Patient test series disabled.
[false]
Enabled
[true]
Patient test series enabled. Configuration You configure the Patient test series configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) This configuration item specifies if linearity tests can be performed on the instrument. When the configuration item is enabled the Linearity button is available on the Tests screen. When it is disabled the button is excluded. Item ID LINEARITY_ENABLED Available values/format Enabled (default) Linearity tests can be performed.
[true]
Disabled
[false]
Linearity tests cannot be performed. Configuration You configure the Allow linearity tests configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Allow proficiency tests This configuration item specifies if proficiency tests can be performed on the instrument. When the configuration item is enabled the Proficiency button is available on the Tests screen. When it is disabled the button is excluded. Item ID PROFICIENCY_ENABLED Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 478 Generic instrument functionality Available values/format Enabled (default) Proficiency tests can be performed.
[true]
Disabled
[false]
Proficiency tests cannot be performed. Configuration You configure Allow proficiency tests configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Insulin dose entry This configuration item specifies whether or not insulin dose entries can be made on the instrument. Item ID LOG_INSULIN Available values/format Disabled
[DISABLED]
Insulin dose entries cannot be made. Enabled (default)
[VIA_TESTS_SCREEN_ONLY]
Insulin dose entries can only made using the Insulin button on the Tests screen. Enabled (via additional dialog after patient testing)
[VIA_TESTS_SCREEN_AND_AFTER_GLUCOSE_TEST]
Insulin dose entries can made:
Using the Insulin button on the Tests screen. After a glucose test has been performed. n o i t a r u g i f n o c l a r e n e G 1 1 Configuration You configure the Insulin dose entry configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) Startup behavior of the instrument This configuration item determines the behavior of the instrument when it starts up. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 479 Depending on the configuration of the configuration item, either the Glucose app or the app library is displayed at startup. Item ID LAUNCH_APP_LIBRARY_ON_TURN_ON Available values/format Automatically start the Glucose app (default) Configuration Message of the day The Glucose app starts up when the instrument starts up. Remain in app library
[false]
[true]
The app library is displayed when the instrument starts up. You configure the Startup behavior of the instrument configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) User interface (only during initial configuration) This configuration item enables you to create a message which can be uploaded to specific or all instruments. The message is displayed in the Settings >
Notifications option in the Glucose app. The user receives notification when the message is available. Item ID MESSAGE_OF_THE_DAY Available options/values ST: 0-120 This configuration item can contain Unicode characters. No default value set. Configuration You configure the Message of the day configuration item using the following:
Data management system (e.g., cobas infinity POC) Cleaning In this section Time interval for cleaning notification (in hours)(480) Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 n o i t a r u g i f n o c l a r e n e G 1 1 480 Generic instrument functionality Time interval for cleaning notification (in hours) Cleaning notification after each patient test(480) This configuration item specifies the time in hours since instrument cleaning was last performed and when a cleaning notification is displayed. The notification is displayed on the Settings >
Notifications screen. You confirm that the instrument has been cleaned by choosing the Confirm button on the Instrument cleaning dialog box. The time interval to the next cleaning alert commences with the confirmation. Item ID CLEANING_ALERT_HOURS Available values/format INT:0-999 hours Default value = "0" hours Configuration You configure the Time interval for cleaning notification (in hours) configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics List of notifications (72) This configuration item determines if the user is notified to clean the instrument after a patient test has been made. The notification is displayed on the Settings >
Notifications screen. Item ID CLEANING_REQUIRED Available values/format Disabled (default) A cleaning notification is not displayed after a patient test has been made.
[false]
Enabled
[true]
Cleaning notification after each patient test n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 General configuration 481 A cleaning notification is displayed after a patient test has been made. Configuration You configure the Cleaning notification after each patient test configuration item using the following:
Data management system (e.g., cobas infinity POC) Barcode (generated via cobas infinity edge) u Related topics List of notifications (72) n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 482 Generic instrument functionality Page intentionally left blank. n o i t a r u g i f n o c l a r e n e G 1 1 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 483 Glossary age barcode type battery Length of time a person has lived or a thing has existed. Class of barcodes sharing the same characteristics. ambient temperature Temperature of the immediate surroundings where the equipment is kept. app library Screen where a collection of available apps is displayed. arterial whole blood Electrochemical device consisting of a series of cells that produce electrical energy. battery compartment Compartment that holds the battery. battery compartment cover Cover for the battery compartment. Whole blood that is oxygenated in the lungs and that is found in the left chambers of the heart and in the arteries. battery level Amount of battery power left on the instrument. association bleach Process of connecting a device to the access point of a wireless network and granting access. Corrosive oxidizing disinfectant and bleaching agent. Malicious activity that attempts to or succeeds in collecting, disrupting, denying, degrading, or destroying information system resources or the information itself. attack audit trail Log file with events that are relevant for an audit. It cannot be manipulated by a user. authentication Process of verifying the identity of a user, computer, device, process, or other entity by validating the credentials provided by the entity. blood-borne pathogen Infectious microorganism in human blood that can cause disease in humans. brightness Amount of light that is emitted by a screen. built-in flashlight Component that is used to illuminate the barcode so that the barcode reader can read the barcode. capillary whole blood Whole blood that is obtained from capillary beds by puncturing the skin. autocomplete carry case Software feature that attempts to predict and automatically complete the current string as it is being entered by the user. barcode Hard-shell case for storing and carrying the instrument and its accessories. certification status Optical machine-readable representation of data. Status that indicates whether a certification is valid, expired, or upcoming. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 484 charge indicator direct sunlight Status indicator that shows the status of the charging process. Light that comes from the sun and shines directly onto something, without being reflected off something else first. charging station Device that connects portable devices to a power source and to other peripherals. disinfection cleaning solution Process to eliminate most pathogenic microorganisms without neccesarily killing or removing all organisms
(e.g., bacterial spores). Solution that is used for cleaning of surfaces and parts of a system. disposable gloves cobas pulse charging station Protective and disposable gloves used in hospitals and other healthcare facilities. Product name for the charging station used for the cobas pulse system. electromagnetic compatibility Written remark about something that is relevant for the user. emergency glucose test comment configuration Ability of signals and interference to coexist without loss of the information contained in the wanted signal. Glucose test that is performed without patient identification through the system and with or without user authentication. emergency test Test that is performed without patient identification through the system in order to get a patient tested as fast as possible. environmental conditions Set of conditions for operating a particular system or process. Rectangular frame that delimits the capture area for scanning. Thin translucent fabric of silk, linen, or cotton. Data type included in patient demographics. frame gauze gender Arrangement of a system that is defined by the nature, the number, the interconnection, and chief characteristics of its functional units. critical range Range of test results that indicates that a patient's life is in danger or that the patient will suffer some form of harm. data management system System that facilitates the creation, organization, retrieval, maintenance, and use of an electronic database. Data type included in patient demographics. Picker that allows a user to select a date. date of birth date picker detergent Cleaning solution that is used for removing dirt and grease from a variety of surfaces and materials. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 485 Parameter that provides information about the presence of glucose in a sample. glucose glucose test In vitro diagnostic test for the quantitative determination of glucose in a patient's sample. hand-held instrument Instrument that is small enough to be hand-held. linearity material QC material used for linearity tests. linearity test Measuring procedure that tests the linearity of the system over the full range of analyzed values. lint-free cloth Type of cloth that does not leave any lint/fabric fiber behind when used. healthcare facility local result Any location where healthcare is provided. Test result that is stored locally on a device. heel-stick whole blood malicious software Capillary whole blood that is collected through a heel stick. Software that fulfills the deliberately harmful intent of an attacker when run. infection measuring range Invasion of an organism by infectious agents, their multiplication, and the reaction to the toxins they produce. Range of test results within which a test fulfills the specifications. insulin Hormone that is essential for the metabolism of carbohydrates and the regulation of glucose levels in the blood and that when insufficiently produced results in diabetes mellitus. insulin type lancet Small double-edged blade that is held by a lancing device. lancing device Device that holds a lancet and is used for obtaining small capillary blood samples. Storage space available within a computer or mobile device. memory normal range Defined range of test results that indicates a healthy medical condition of a patient. Color-filled circle on a user interface element that notifies the users of recent events they have not yet acted upon. observed test sequence Workflow where a sequence of testing done by an operator is performed under supervision of an observer. Class of insulin sharing the same characteristics. notification badge linearity kit on/off button Kit that consists of a predefined number of different linearity materials necessary to perform a linearity test. Button that is used to turn the instrument on and off. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 486 override To neutralize an action. package insert Information regarding the usage of a product that is inserted into the package alongside the product itself. patient ID Unique and permanent identification of a patient throughout the system. patient result Result of a patient test. power supply QC lockout Lockout that occurs in case of a QC error or a due QC test. Substance, material, or article intended by its manufacturer to be used to verify the performance characteristics of an in vitro diagnostic medical device. QC lot Lot of a QC material. QC material QC result Result of a QC test. QC test Electrical device that is used to convert electric current from a source to the correct voltage, current, and frequency to power the load. Test that is run with QC material. proficiency material qualitative result Material that is used for a proficiency test. Result type that provides information about the presence of an analyte or target in the sample. proficiency test Method that is used to analyze the reproducibility of test results by comparing them among independent organizations in order to validate a measurement process. quality assurance Program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. puncture site quantitative result Area on the skin where a needle is inserted to draw blood. Result type that provides information about the amount of the analyte in a sample. It can be evaluated against the expected values. QC interval Number of patient tests or the amount of time between 2 QC tests. QC kit QC level Concentration of a QC material. radio frequency Any of the electromagnetic wave frequencies that lie in the range extending from below 3 kilohertz to about 300 gigahertz and that include the frequencies used for communications signals. Range of test results that indicates that the concentrations of an analyte can be measured with acceptable accuracy and precision. Kit that consists of a predefined number of different QC materials necessary to perform QC tests. reportable range Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 487 RFID reader standby mode Component that interprets the data stored in the RFID tag and read by the RFID antenna. RFID tag Operating mode that is activated when the system is not performing any processing or measurement. The system is ready to exit this operating mode and return to the normal mode with a short delay. Component that stores the data that can be read by the RFID antenna and interpreted by an RFID reader. status indicator Roche Service representative Roche representative who may install instruments and/or perform preventive maintenance and/or service activities. Device indicating the status of a component. synchronization lockout Lockout that occurs when the instrument could not synchronize with the DMS for a defined period of time. Kind of substance or material that is tested. system sample type self-check settings Process carried out by the analyzer during startup and assay runs that checks if the analyzer is working correctly and monitors its performance. Options that allow users to customize their applications or operating system. test setup password Password that allows the user to change the settings on an instrument. shift Each of two or more recurring periods in which different groups of workers do the same jobs in relay. software update Process of changing a software in order to improve it, fix it, or make it more current. splash screen Set of interconnected elements in a complex whole designed to fulfill its own regulatory relevant intended use. temperature lockout Lockout that is due to a temperature excess of the instrument. Measuring procedure that requires laboratory equipment and reagents in a specific clinical context and for a specific clinical purpose, in a specific population. test result Result of a test. test strip Chemical reagent strip that is used to test a parameter of a sample or QC material. test strip container Container for test strips. Initial screen displayed by interactive software, usually containing a logo, version information, author credits, or a copyright notice. test strip ID ID to identify a test strip. test strip lot Lot of test strips. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 488 test strip port venous whole blood Port that is used to insert a test strip into an instrument or meter. test strip port light Whole blood that has passed through the capillaries of various tissues, except the lungs, and is found in the veins, the right chambers of the heart, and the pulmonary arteries. Light that illuminates the test strip port and gives information about the quality of the test strip and the status of the measurement workflow. virtual keyboard Keyboard displayed and used on a touch screen. test type volume Classification of tests based on how and with what a test measures something. Loudness of an audio signal. Picker that allows a user to select a time. time picker toggle button touch screen user Interactive user interface element that allows a user to change a setting between two statuses. Screen that allows the user to give input by touching it. Person who interacts with all or certain systems or software solutions. user ID Unique identifier of a user. user interface Means by which the user and the medical device interact. Lockout that occurs when a user certificate expires. user lockout user rights Tasks that a user is permitted to perform on a computer system or domain. Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 489 Index Accessories and consumables, 89 Addresses, 5 App bar, 44 App library, 46 Audit trail, 148, 192 Barcodes, 90 Battery, 177, 193 Blood sample collection, 51 Carry case, 40 clean and disinfect, 176 Charging, 45, 104 Charging station, 39, 154 clean and disinfect, 175 Cleaning solutions and disinfectants, 171 Comments, 62, 128 Contact, 5 abbreviations, 11 Copyright, 3 Conventions used in this publication Edition notice, 2 Emergency glucose test, 139 Environmental conditions, 87 Error messages Level 1 messages, 213 Level 2 errors, 229 Feedback, 4 A B C E F clean and disinfect, 169, 172 synchronization status, 73 Glucose app, 47, 99 Glucose test, 52, 54, 116 G I Instrument brightness, 147 components, 37 delete data, 191 reset, 185 restart, 153 turn off, 152 turn on, 151 volume, 147 Insulin, 131 L Linearity lot, 160 Linearity test, 60, 135 Lockout, 68, 190 Logon, 99 Lot management, 155 linearity lot, 160 QC lot, 160, 161, 162 Message of the day, 74 M N Navigation bar, 44 Network status, 186 Notifications, 72, 105 test strip lot, 155, 156, 158, 159 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Tests screen, 46 U User assistance, 75 User interface, 41 app bar, 44 navigation bar, 44 status bar, 43 W Warranty, 3 490 Observed test sequence (OTS), 62, 145 O P Q R S T Password, 22, 150 Patient, 49, 113, 120 Proficiency test, 60, 142 QC lockout, 66, 68 QC lot, 160, 161, 162 QC test, 58, 122, 126 Revision history, 2 Safety classifications, 17 Safety information precautions, 18 Screenshot disclaimer, 2 Software, 41 Standby mode, 107, 108 Status bar, 43 System, 35 Technical specifications, 86 Test strip lot, 155, 156, 158, 159 Test strip port light, 64 Testing principle, 36 Tests, 49 emergency glucose test, 139 glucose test, 52, 54, 116 linearity test, 60, 135 patient test results, 120 proficiency test, 60, 142 QC test, 58, 122 QC test results, 126 observed test sequence (OTS), 62, 145 Roche Diagnostics cobaspulse Software version 01.03 User Assistance Publication version 1.0 Page intentionally left blank. Published by:
Roche Diagnostics International Ltd CH-6343 Rotkreuz Switzerland www.roche.com
1 2 3 | Label | ID Label/Location Info | 81.16 KiB | December 17 2021 |
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1 2 3 | LTC | Cover Letter(s) | 2.02 MiB | December 17 2021 |
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:
FCC ID:
Check your GC here. Click "Grantee Search"
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 trade secrets and proprietary benefit to our competitors. This information will not be publicly available. information that could be of 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:
Document Version 1.0 2020-08-31
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-12-17 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
2 | 13.56 ~ 13.56 | DXT - Part 15 Low Power Transceiver, Rx Verified | ||
3 | 5745 ~ 5825 | NII - Unlicensed National Information Infrastructure TX |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 | Effective |
2021-12-17
|
||||
1 2 3 | Applicant's complete, legal business name |
Roche Diagnostics GmbH
|
||||
1 2 3 | FCC Registration Number (FRN) |
0016954943
|
||||
1 2 3 | Physical Address |
Sandhofer Strasse 116
|
||||
1 2 3 |
Mannheim, N/A
|
|||||
1 2 3 |
Germany
|
|||||
app s | TCB Information | |||||
1 2 3 | TCB Application Email Address |
t******@ctcadvanced.com
|
||||
1 2 3 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
1 2 3 |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
|||||
app s | FCC ID | |||||
1 2 3 | Grantee Code |
VO9
|
||||
1 2 3 | Equipment Product Code |
COBASPULSE
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 | Name |
C**** P******
|
||||
1 2 3 | Telephone Number |
+4962******** Extension:
|
||||
1 2 3 | Fax Number |
+4962********
|
||||
1 2 3 |
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 3 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 | 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 3 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 3 | DXT - Part 15 Low Power Transceiver, Rx Verified | |||||
1 2 3 | NII - Unlicensed National Information Infrastructure TX | |||||
1 2 3 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Blood Glucose meter | ||||
1 2 3 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 | Modular Equipment Type | Does not apply | ||||
1 2 3 | Purpose / Application is for | Original Equipment | ||||
1 2 3 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 2 3 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 3 | Grant Comments | Output power listed is peak conducted. This device supports 802.11b, 802.11g and 802.11n with a 20 MHz, 40 MHz bandwidth mode and Bluetooth Low Energy 1 Msps mode. For limb-worn operation, this device has been tested touched to the phantom and meets FCC RF exposure guidelines. End users must be informed of the limb-worn requirements for satisfying RF Exposure compliance. The highest reported SAR for limb-worn exposure conditions is 0.247 W/kg. | ||||
1 2 3 | Output power listed is average conducted. This device supports 802.11a, 802.11n and 802.11ac with a 20 MHz, 40 MHz and 80 MHz bandwidth mode. Approval is for operation as a client only device without radar detection or ad-hoc capability. For limb-worn operation, this device has been tested touched to the phantom and meets FCC RF exposure guidelines. End users must be informed of the limb-worn requirements for satisfying RF Exposure compliance. The highest reported SAR for limb-worn exposure conditions is 0.431 W/kg. | |||||
1 2 3 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 | Firm Name |
CTC advanced GmbH
|
||||
1 2 3 | Name |
G******** S******
|
||||
1 2 3 | Telephone Number |
49-68********
|
||||
1 2 3 | Fax Number |
49-68********
|
||||
1 2 3 |
m******@ctcadvanced.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2402 | 2480 | 0.0049 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15C | CC | 2412 | 2462 | 0.1122 | |||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | CC | 13.56000000 | 13.56000000 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15E | CC | 5180 | 5240 | 0.0347 | |||||||||||||||||||||||||||||||||||
3 | 2 | 15E | CC | 5260 | 5320 | 0.0309 | |||||||||||||||||||||||||||||||||||
3 | 3 | 15E | CC | 5500 | 5700 | 0.0302 | |||||||||||||||||||||||||||||||||||
3 | 4 | 15E | CC | 5745 | 5825 | 0.0324 |
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