Roche cobas pulse Manual
  1. Manuals
  2. Brands
  3. Roche Manuals
  4. Medical Equipment
  5. cobas pulse
  6. Manual

Roche cobas pulse Manual

Hide thumbs Also See for cobas pulse:
Table of Contents

Advertisement

Quick Links

®
cobas
 pulse
User Assistance
Publication version 1.0
Software version 01.03

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the cobas pulse and is the answer not in the manual?

Questions and answers

Related Manuals for Roche cobas pulse

Summary of Contents for Roche cobas pulse

  • Page 1: In This Chapter

    ® cobas  pulse User Assistance Publication version 1.0 Software version 01.03...

  • Page 2: In This Chapter

    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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 3: In This Chapter

    ® The cobas  pulse 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.

  • Page 4: In This Chapter

    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.

  • Page 5: In This Chapter

    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...

  • Page 6: In This Chapter

    Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 7: In This Chapter

    Performing a glucose test About instrument configuration Reviewing patient test results About the Settings menu access restrictions Performing a QC test Setting the instrument date and time Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 8: In This Chapter

    Connectivity General configuration List of power management options Patient ID handling User ID handling Result range handling Measurement workflow Generic instrument functionality Glossary Index Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 9 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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 10 Unique device identifier TÜV SÜD U7-2D Biohazardous RFID reader. Device contains a transmitter. Device for near-patient testing y Symbols used on product and packaging Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 11 Observed test sequence Radio frequency RFID Radio frequency identification Radio Standards Specification (Canada) Specific absorption ratio Transport layer security WLAN Wireless local area network y Abbreviations Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 12 Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 13 Safety General safety information ................  15 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 14 Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 15: Table Of Contents

    Safety classifications............. Safety precautions ..............Warning messages ..............Caution messages ..............Notices ..................Safety information for disposal ......... Recommendations for cybersecurity and data security..................Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 16 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 17: Safety Classifications

    Important information that is not safety relevant is indicated with the following icon: Tip..indicates additional information on correct use or useful tips. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 18: Safety Precautions

    Use of non-approved parts or devices may result in Non-approved parts malfunction of the system and may render the warranty null and void. r Use only parts and devices approved by Roche Diagnostics. Electromagnetic compatibility (EMC) The system complies with the emission and immunity requirements described in IEC 61326-2-6.
  • Page 19 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. Radio frequency radiation exposure The industrial, scientific and medical (ISM) radio...

  • Page 20: Warning Messages

    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.
  • Page 21 Follow all health and safety regulations in force locally. r Only use Roche original accessories (cables, power Avoiding electrical shock, fire, and explosions supplies, batteries). Third-party cables, power supplies, and batteries can cause the battery to explode or the instrument to become damaged.

  • Page 22: Caution Messages

    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.
  • Page 23 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 24: Notices

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 25: Safety Information For Disposal

    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. Disposal of electronic equipment This symbol appears on any component of the system that is covered by the European Directive on waste electrical and electronic equipment (WEEE).

  • Page 26: Recommendations For Cybersecurity And Data Security

    Physical access controls 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.
  • Page 27 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 28 Authentication of communication end points You can use EAP as a safety measure. This measure (use EAP and TLS) 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...
  • Page 29 DMS. Wiping data from the instrument Prior to disposal of an instrument, wipe the stored data using Settings > Administrator > Delete instrument data. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 30 Recommendations for cybersecurity and data security Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 31 System description Overview of the system ................ 33 Specifications.................... 83 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 32 Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 33 List of notifications ..............Overview of the User Assistance ........About the User Assistance........Overview of User Assistance functions ....Accessing the User Assistance online....Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 34 Table of contents Accessing the User Assistance offline ....Searching in the User Assistance......Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 35: About The System

    Transfer automatically all recorded information to the DMS. This system comprises the following components: Instrument Carry case (may not be available in all countries) Charging station w System components Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 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. 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.

  • Page 37: About The Instrument

    Putting the instrument into standby mode (107) Test strip port Port for test strip insertion. Lighting indicates test-strip- related actions that should be taken. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 38 Publication information (2) Symbols and abbreviations (9) RFID reader The RFID reader is used to read the following: • User IDs • Patient IDs Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 39: Overview Of The Charging Station

    The power supply is attached at the rear of the charging station. To charge the instrument, you place it in the cradle. Setting up the charging station (154) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 40: 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. w Carry case Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 41: Overview Of The User Interface

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 42 Network status test Administrator Reset synchronization lockout Delete instrument data Legal information w Overview of the cobas pulse software Instrument configuration menu item contains the following sub menu items (not shown in the overview): • ID configuration • QC interval •...

  • Page 43: About The User Interface

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 44 Emergency test • Linearity test • Proficiency test • Insulin entry Depending on your instrument’s configuration, not all of the tests may be available. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 45: About The Charging Screen

    Site • Yellow =16% to 89% Location • Green = 90% and above The battery indicator color corresponds with the instrument’s charge indicator color. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 46: About The Tests Screen

    About lockouts (66) About the app library The app library contains the apps that you can use on the instrument. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 47: About The Glucose App Start Screen

    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.
  • Page 48 • Instrument name and/or ID (top of screen). • Site and location where the instrument is used (bottom of screen). Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 49: About Tests

    The entry methods are: • RFID tag • Barcode scanning • Keyboard entry Your instrument can be configured to determine which entry methods you can use. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 50 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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 51: About Collecting A Blood Sample

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 52: About Performing A Glucose Test

    Glucose test series • Insulin entry Patient confirmation Your instrument can be configured so that you must confirm that the patient entered is correct. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 53 Comment entry for glucose tests on the instrument can be configured as follows: • Disabled • Optionally required • Always required Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 54: About Glucose Test Results

    Glucose test result screen is displayed after the blood sample has been measured. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 55 You can view the values of the test result ranges by tapping the button. The color coding used for the test result ranges is indicated in the figure. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 56 The test result value is within the mg/dL normal range. Normal range The test result value is below the normal range but not yet critically mg/dL low. Below normal range Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 57 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 58: About Performing Qc Tests

    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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 59 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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 60: About Proficiency Testing

    Linearity samples should be treated in the same manner as the QC materials used in QC testing. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 61 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 62: About The Observed Test Sequence (Ots)

    Within normal range No comments Confirm Comment entry optional Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 63 Patient-related test comments instrument can be configured so that a comment must be entered when a result is within one of the following categories: Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 64: About The Test Strip Port Light

    • Instrument is turning on • Error during self-checks • Errors during measurement • Test strip ejected White • Ready for test strip insertion Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 65 Test strip checked and passed White • Ready for sample application Blue • Sufficient sample has been applied and processing is underway Magenta • Eject test strip Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 66: About Lockouts

    The QC algorithm is configured on the instrument through the DMS, or by using a QR code. The following configurations are possible: • QC disabled Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 67 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 68: Lockout Types

    To remove a non-alternating QC lockout, you must perform QC tests with QC level 1 and 2 passed. A software update (from Roche) can be configured to Software update trigger a QC lockout. The QC lockout applies irrespective of any other QC lockout that was configured.
  • Page 69 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 70 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 71 This enables the user who was locked out to perform tests again. User certification status (74) Performing an observed test sequence (OTS) (145) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 72: List Of Notifications

    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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 73 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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 74 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 75: Overview Of The User Assistance

    Main panel Buttons for navigation and other functions Panel splitter Detail panel w Overview of the User Assistance window Tabs in the main panel Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 76: Overview Of User Assistance Functions

    Browsing history You can use the navigation buttons to go backwards and forwards in your browsing history. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 77 Downloading a PDF You can download the publication to your computer in PDF format using the Download PDF button. Download PDF Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 78: Accessing The User Assistance Online

    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.
  • Page 79 You can use the standalone User Assistance offline on your PC. No internet connection is required. To get the installer for the standalone User Assistance, contact your Roche representative. 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.
  • Page 80 The icon on the left of the search results shows you the topic type: Description Explains concepts and gives additional background information. Procedure Explains how to perform a task step-by-step. Reference Provides reference information. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 81 The filter drop-down lists are displayed. Search in this publication 4 From the drop-down lists, choose one or more search filters. Search results Type Topic Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 82 Overview of the User Assistance Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 83 In this chapter General specifications............Technical specifications ............Environmental conditions ........... Dimensions and weights............. List of accessories and consumables......Barcode specifications............Radio equipment specifications ........Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 84 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 85: General Specifications

    WLAN IEEE 802.11 a/b/g/n/ac (single stream n) ® • Bluetooth Charging station • Wireless power transfer (WPT) Power supply • DC connector • Replaceable AC input contacts y General specifications Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 86: Technical Specifications

    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) y Technical specifications Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 87: Environmental Conditions

    Charging station 4,300 m 14,107 feet Power supply 4,300 m 14,107 feet Instrument Refer to the package insert for information Sample temperature y Environmental conditions Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 88: Dimensions And Weights

    Depth Height 250 mm 9.85 in 305 mm 12 in Width Weight 1000 g 2.20 lb y Dimensions and weight of the carry case Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 89: List Of Accessories And Consumables

     pulse battery Battery 08726388 ® Power supply 08689008 cobas  pulse power supply POC Access Point Wi-Fi access point 09187316 y Accessories and other components Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 90: Barcode Specifications

    Roche representative. 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.
  • Page 91 Supported barcode types Codabar Code 39 Code 93 Code 128 EAN 13 GS1 DataBar Limited Interleaved 2 of 5 without checksum Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 92 Barcode specifications Interleaved 2 of 5 with checksum PDF417 Aztec DataMatrix QR code Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 93: Radio Equipment Specifications

    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 -...
  • Page 94 Radio equipment specifications Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 95 Operation Frequently performed tasks...............  97 Routine operation.................. 111 Non-routine operation................ 129 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 96 Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 97 Charging the instrument ............. Checking notifications ............Putting the instrument into standby mode....Waking the instrument from standby mode ....Logging off the Glucose app ..........Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 98 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 99: Logging On To The Glucose App

    If the app library is displayed, tap the Glucose app and then in the Glucose screen, tap the button. f The User logon screen is displayed. Log on Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 100 2 In the User logon screen, if the Scan user ID tab is not displayed, tap the tab. f The barcode camera is activated, Log on Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 101 Logon is complete. 5 When you have finished using the instrument, dock it in the charging station. f You are logged off automatically. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 102 Enter user ID screen enter your user ID and then tap the Next button. User logon The user ID is case sensitive. Enter user ID Next Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 103 • Performing a glucose test (116) • Performing a QC test (122) • Reviewing patient test results (120) • Reviewing QC test results (126) Proceed Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 104: Charging The Instrument

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 105: Checking Notifications

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 106 • Tap the message to display the corresponding message screen. • After reading the message, tap the button to return to the Notifications screen. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 107: Putting The Instrument Into Standby Mode

    To put the instrument into standby mode 1 Press the on/off button firmly. The instrument vibrates. f The instrument goes into standby mode. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 108: Waking The Instrument From Standby Mode

    The instrument vibrates. f The instrument wakes from standby mode. f Depending on the instrument’s configuration the Glucose screen or the app library is displayed. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 109: Logging Off The Glucose App

    Press the on/off button. • In the Tests screen, the Local results screen, or Notifications screen, tap the button. f You are logged off the Glucose app. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 110 Logging off the Glucose app Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 111 Performing a glucose test........... Reviewing patient test results ........... Performing a QC test ............Reviewing QC test results........... Adding comments to a test result ........Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 112 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 113: Entering A Patient

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 114 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 115: Related Topics

    • Press the Cancel button to stop the patient entry. u Related topics • Performing a glucose test (116) • Entering insulin information (131) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 116: Performing A Glucose Test

    QC test. However, if the QC lockout was the result of a failed QC test, the QC lockout cannot be overridden. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 117 Glucose button. Tests 2 Enter the patient ID using one of the following methods: • RFID tag • Barcode scan • Keyboard entry Glucose Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 118 6 Tap the Confirm button Within normal range f The Eject test strip dialog box is displayed. No comments Confirm Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 119 • 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) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 120: Reviewing Patient Test Results

    You are logged on to the instrument. Logging on to the Glucose app (99) r To review a patient test result 1 On the navigation bar, tap the button. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 121 Gender box. Glucose • Tap the button to return to the Local results screen. mg/dL Within normal range No comments Test strip lot number Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 122: Performing A Qc Test

    The procedures for performing Level 1 and Level 2 tests are the same. Colored test strip port light provides guidance of instrument statuses / actions you must take. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 123 Choose QC lot screen. tap the tab, and then tap the lot number that you are using. tab might be deactivated in your healthcare facility. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 124 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 125 Passed u Related topics No comments • Adding comments to a test result (128) • About the test strip port light (64) Confirm Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 126: Reviewing Patient Test Results

    22-Mar-2020, 16:31 Regular insulin Jenny Doe 1234567890 22-Mar-2020, 15:27 Glucose John Doe mg/dL 123123123 22-Mar-2020, 15:27 Glucose Jenny Doe mg/dL 1234567890 22-Mar-2020, 15:27 Glucose Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 127 Passed • Tap the button to return to the QC results tab. No comments QC lot number 99999999 Test strip lot number 567890 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 128: Adding Comments To A Test Result

    No action • Tap the Save button f The Comments dialog box closes. Invalid result Result will be excluded from local results history. Cancel Save Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 129 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 ....Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 130 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 131: Entering Insulin Information

    Scan the patient details barcode. • Tap the tab, enter the patient name or the patient ID, and then tap the Continue button. Insulin Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 132 Rapid-acting insulin the change, tap the Next button to return to the current screen. Regular insulin Intermediate-acting insulin Long-acting insulin Insulin mixtures Previous Next Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 133 You can add a free-text comment of up to 20 characters. Enter a comment Physician notified RN notified No action Procedure error Previous Next Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 134 Insulin type u Related topics • Performing a glucose test (116) Insulin name • Entering a patient (113) Insulin units Comments Confirm Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 135: Performing A Linearity Test

    • If enabled, tap the tab and then below Choose linearity kit lot, tap the lot you will use to perform the test. Linearity Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 136 You have 180 seconds. When sufficient material has been applied, the test strip port light color turns blue. An audible signal is emitted. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 137 4 to 7. 23.4 f The result of the second run is displayed. mg/dL Passed Linearity kit lot number Test strip lot number Proceed Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 138 > QC results. No comments u Related topics Linearity kit lot number Test strip lot number • Reviewing QC test results (126) Confirm Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 139: Performing An Emergency Glucose Test

    You are logged on to the instrument. m Your instrument is configured to perform emergency glucose tests. Logging on to the Glucose app (99) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 140 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 141: Adding Comments To A Test Result

    • Entering insulin information (131) • Adding comments to a test result (128) • About collecting a blood sample (51) • About the test strip port light (64) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 142: Performing A Proficiency Test

    You are logged on to the instrument. m Instrument is not in QC lockout. Logging on to the Glucose app (99) Performing a QC test (122) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 143 When sufficient material has been applied, the test strip port light color turns blue. An audible signal is emitted. 5 Depending on your instrument’s configuration do the following: Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 144: Caution! When You Eject The Test Strip, Ensure That You Dispose Of It In Accordance With The Applicable Regulations

    If it does not, gently shake the instrument to help test strip to fall out. u Related topics • Reviewing QC test results (126) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 145: Performing An Observed Test Sequence (Ots)

    In the Result screen, tap the Proceed button. 4 OBSERVER: In the Observer logon screen, enter your password and tap the Log on button. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 146 • Review the assessment. • If necessary, amend the assessment by tapping the appropriate option and make the change. • Tap the Confirm button. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 147: Adjusting The Screen Brightness And The Volume Level

    Volume slider to the left. When you stop moving the slider, the instrument emits an audible signal, indicating the volume level for that setting. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 148: Reviewing The Audit Trail

    The corresponding Audit trail details screen is Instrument error G-AA displayed. 22-Mar-2020, 15:27 Instrument cleaning performed 21-Mar-2020, 10:13 Wi-Fi association problem 21-Mar-2020, 10:13 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 149 Audit trail details 5 To return to the Audit trail screen. tap the button, User logon Date and time 22-Mar-2020, 15:27 Event User logged on. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 150: Changing Your User Password

    3 Choose the Save button. 4 In the Password changed dialog box, tap the Confirm button. f Your password is changed. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 151: Turning On The Instrument

    In each case an audible beep is made. f The cobas splash screen displays and then, depending on the instrument’s configuration, the Glucose screen or the app library is displayed. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 152: Turning Off The Instrument

    The instrument emits regular beeps while you do this. 2 Tap the Power off option. f The splash screen displays and the instrument turns off. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 153: Restarting The Instrument

    The splash screen displays and the instrument restarts. f The splash screen displays again. Depending on the instrument’s configuration the Glucose screen or the app library is displayed. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 154: Setting Up 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 155: Lot Management

    DMS). The lot data file is distributed from the DMS to the healthcare facility instruments. y  Digital lot data reception with manual release workflow Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 156: Adding A Test Strip Lot To The Instrument

    The distribution of test strips from a new lot will depend on the best practice of your healthcare facility. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 157 If prompted, perform a QC test using the new test strip lot. Add test strip lot After performing the QC test successfully you can start using the test strips from the new lot. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 158: Reviewing Test Strip Lot Details On The Instrument

    Review the test strip lots on the instrument. Test strip lots QC lots • Tap a lot to view its details. Lot No. Type Expiry date Add test strip lot Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 159: Deleting A Test Strip Lot From The Instrument

    As required r To delete a test strip lot from the instrument 1 In the Glucose app, tap > Lot management. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 160: Adding A Qc Or Linearity Lot To The Instrument

    The distribution of a new QC or linearity kit will depend on the best practice of your healthcare facility. As required m New QC or linearity lot bottle Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 161: Reviewing Qc Lots On The Instrument

    The following information is available when reviewing an individual linearity lot: • Lot No. • Expiry date • Linearity version • Type As required Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 162: Deleting A Qc Lot From The Instrument

    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 ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 163 QC version Type Glucose, QC level 1 Default target range 47 - 71 mg/dL Hospital-defined target range 53 - 65 mg/dL Current lot Delete Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 164 Lot management Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 165 Maintenance Maintenance .................... 167 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 166 Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 167 Cleaning and disinfecting the instrument ....Cleaning and disinfecting the charging station ..Cleaning and disinfecting the carry case ..... Replacing the battery ............Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 168 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 169: About Cleaning And Disinfecting The Instrument

    Only use cleaning solutions and disinfectants recommended by Roche. Instrument cleaning status This notification indicates that either: • Instrument cleaning is due (date/event).
  • Page 170 About cleaning and disinfecting the instrument u Related topics • Cleaning and disinfecting the instrument (172) • Acceptable cleaning solutions and disinfectants (171) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 171: Acceptable Cleaning Solutions And Disinfectants

    Related topics • About cleaning and disinfecting the instrument (169) • Cleaning and disinfecting the instrument (172) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 172: Cleaning And Disinfecting The Instrument

    Disposable gloves m Soft, lint-free cloth or gauze m Premoistened wipes for cleaning and disinfection m Cleaning solutions as per the manufacturer’s product labelling. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 173 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 174 Related topics • About cleaning and disinfecting the instrument (169) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 175: Cleaning And Disinfecting The Charging Station

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 176: Cleaning And Disinfecting The Carry Case

    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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 177: Replacing The Battery

    Treat it accordingly. As necessary < 10 minutes 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. Roche Diagnostics ®...
  • Page 178 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 179 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. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 180 Replacing the battery Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 181 Troubleshooting Troubleshooting ................... 183 Error messages..................... 195 Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 182 Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 183 Network status test steps ........... Resetting a synchronization lockout....... Deleting instrument data ............ List of audit trail events ............Starting up an instrument with low battery level ..Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 184 Table of contents Page intentionally left blank. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 185: Resetting The Instrument

    The instrument turns off and on again. f The splash screen is displayed. f Depending on the instrument’s configuration, the Glucose app screen or the app library is displayed. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 186: Running A Network Status Test

    Network status test steps (188) r To run a network status test 1 Tap > Instrument information > Network status test. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...
  • Page 187 The test result is displayed. Test Wi-Fi activated Associated Authenticated Received IP: 10.0.0.100 Gateway: 10.0.0.1 DNS: 10.0.0.1 Contacted DMS Connected to DMS Contacted cobas infinity edge Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 188: Network Status Test Steps

    Instrument SW attempts to Wi-Fi hardware defective Restart the instrument and try activate the Wi-Fi hardware again. If the problem persists, contact your Roche representative. Associated WLAN hardware initiates Wireless network out of reach Move the instrument to a connection to wireless access...
  • Page 189  Network status test steps Running a network status test (186) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 190: Resetting A Synchronization Lockout

    > Administrator > Reset synchronization lockout. If configured, enter the setup password to access the Administrator submenu. f A message is displayed saying Synchronization lockout was reset. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 191: Deleting Instrument Data

    Delete instrument data dialog box is displayed, explaining the implications of confirming. 2 In the Delete instrument data dialog box, tap the Confirm button. Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

  • Page 192: List Of Audit Trail Events

    Software update was performed. Software configuration: <SW_configuration>. Self-check was passed. QC lockout occurred. Synchronization lockout occurred. y  Audit trail events Reviewing the audit trail (148) Roche Diagnostics ® cobas  pulse · Software version 01.03 · User Assistance · Publication version 1.0...

Table of Contents

Save PDF