Roche cobas pulse User Manual
  1. Manuals
  2. Brands
  3. Roche Manuals
  4. Blood Glucose Meter
  5. cobas pulse
  6. User manual

Roche cobas pulse User Manual

Hide thumbs Also See for cobas pulse:
Table of Contents

Advertisement

Quick Links

Download this manual
cobas® pulse
User Guide
Publication version 3.0

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 cobas® pulse User Guide Publication version 3.0...

  • Page 2: Publication Information

    Always follow the instructions in this publication. r Only use the instrument in the way that is described in this publication. r Store all publications in a safe and easily accessible place. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 3 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 To view the full text of the 2014/53/EU declaration of conformity, go to the navify Portal website (navifyportal.roche.com) and choose the eLabDoc link. If you are unable to access navify Portal, contact a Roche Service representative. Compliance with the applicable directives is provided by means of the declaration of conformity.

  • Page 5: Contact Addresses

    Contact addresses Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany Roche affiliates A list of all Roche affiliates can be found at: https://www.roche.com/worldwide eLabDoc Electronic user documentation can be downloaded using the eLabDoc e-service on navify portal: navifyportal.roche.com For more information, contact your local affiliate or Roche Service representative.
  • Page 6 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 7: Table Of Contents

    Waking the instrument from standby mode Logging off from the Glucose app Non-routine operation Unpacking the instrument Setting up the charging station Turning on the instrument Changing your user password Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 8 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 9: Intended Use

    QC kit QC kit cobas® infinity POC cobas® infinity edge backend service cobas® GLU linearity kit linearity kit y Product names and descriptors Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 10 Symbols used in the publication Symbols used on product and packaging Symbol Explanation Manufacturer Date of manufacture Catalogue number In vitro diagnostic medical device y Symbols used on product and packaging Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 11 Humidity limitation Refer to safety information included in this publication. Consult the Instructions for Use y Symbols used on product and packaging Abbreviations This list of abbreviations is used: Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 12: What Is New In Publication Version 3.0

    About the Settings menu access restrictions u Allow access to audit trail Addition of RFID tag types specifications u General specifications L2 error messages update u Level 2 errors Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 13 With Logon session timeout activated, the instrument session timeout” setting activated does not log off automatically when placed in the charging station. Logging off from the Glucose app (69) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 14 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 15 Safety General safety information............ 17 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 16 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 17 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............... Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 18 Table of contents Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 19: Safety Classifications

    Important information that is not safety relevant is indicated with this icon: Tip..indicates additional information on correct use or useful tips. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 20: Safety Precautions

    Use of non-approved parts or devices may result in malfunction of the system. It 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 21: Warning Messages

    Running a QC test (60) r Always wear a new, clean pair of gloves for each test you run. r Use only parts and devices approved by Roche Diagnostics. r Do not use the instrument outside the specified temperature range.
  • Page 22 Follow all health and safety regulations in force locally. Avoiding electrical shock, fire, and explosions 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.

  • Page 23: Caution Messages

    Failure to do so may result in data loss or may make 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.
  • Page 24 5 seconds. Thereafter the button is disabled for each successive invalid attempt. When a password penalty is triggered, the corresponding audit trail event for a password penalty is logged. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 25: Notices

    Replacement instrument tests not run when the instrument being used malfunctions. r Make sure that there is always a working backup instrument readily available that can replace a malfunctioning instrument. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 26: Safety Information For Disposal

    Dispose of the instrument or its components in line with the appropriate local regulations or you may return it to Roche. For more details, 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 27: Recommendations For Cybersecurity And Data Security

    (such as a nurse) to look up previous patient measurement results when the network or DMS is unavailable. For more information on cybersecurity and data security, refer to the User Assistance. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 28 Recommendations for cybersecurity and data security Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 29 System description Overview of the system .............. 31 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 30 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 31 About the system ............About the instrument ..........Overview of the charging station ....... Overview of the carry case......... About glucose test results ......... About running QC tests..........Environmental conditions........... Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 32 Table of contents Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 33: About The System

    Record test results and reagent information. • Record data related to quality assurance. • Transfer automatically all recorded information to the DMS. This system consists of: Instrument Carry case Charging station w System components Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 34 The carry case may not be available in all countries. System extension Through the app library, the system provides the option to install additional Roche-controlled apps with other functionalities. 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 35: About The Instrument

    Symbols and abbreviations (9) Environmental conditions Only operate the meter under these conditions: • Temperature range: 54 °F–104 °F (12 °C–40 °C) • Humidity: 10%–90% non-condensing • Maximum altitude: up to 14,107 feet (4,300 meters) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 36: Overview Of The Charging Station

    (e.g., on a wall). The power supply is attached at the rear of the charging station. To charge the instrument, place it in the charging station. Setting up the charging station (74) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 37: Overview Of The Carry Case

    The carry case provides an area for storing and transporting consumables needed for running blood glucose tests. The carry case may not be available in all countries. w Carry case Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 38: About Glucose Test Results

    American Diabetes Association website: Diagnosing Diabetes and Learning about Prediabetes. http://www.diabetes.org/diabetes-basics/ diagnosis/., last accessed on 02.Sep.2021. D’Orazio et al.: “Approved IFCC Recommendation on Reporting Results for Blood Glucose (Abbreviated);” Clinical Chemistry 51:9 1573-1576 (2005). Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 39: About Running Qc Tests

    When a QC test is required, you will not be able to test blood glucose until the QC tests have been run successfully. QC materials Use Roche QC materials (cobas® GLU QC kit). 2 QC levels available: • Level 1 (L1): Low (low values in test results) •...

  • Page 40: Environmental Conditions

    (above sea level) Charging station 4,300 m 14,107 feet Power supply 4,300 m 14,107 feet Sample temperature Instrument Refer to the Instructions for Use for information y Environmental conditions Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 41 Operation Routine operation................ 43 Non-routine operation .............. 71 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 42 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 43 Running a QC test............Reviewing QC test results .......... Putting the instrument into standby mode....Waking the instrument from standby mode ....Logging off from the Glucose app ......Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 44 Table of contents Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 45: Charging The Instrument

    1 Place the instrument in the charging station. 2 Make sure the charging screen appears. f If not, check that the charging station is connected to a power source. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 46: Logging On To The Glucose App

    Make sure you are logged off. Next r To log on to the Glucose app using a barcode 1 In the User logon screen, tap the tab. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 47 Log on button, or Glucose • In the app library, tap the Glucose app. Then, tap Log on button. f The User logon screen appears. Log on Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 48 Related topics • Running a glucose test (53) • Running a QC test (60) • Reviewing patient test results (58) • Reviewing QC test results (64) Proceed Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 49: Checking Notifications

    6 For a notification of a message: • Tap the message to display it on the screen. • After reading the message, tap the button to return to the Notifications screen. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 50: Entering A Patient

    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. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 51 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 · User Guide · Publication version 3.0...
  • Page 52 Date of birth patient ID. Cancel Confirm • Tap the Cancel button to stop the patient entry. u Related topics • Running a glucose test (53) • Entering insulin information (88) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 53: Running A Glucose Test

    Incorrect use of anticoagulant can lead to an incorrect test result and have a harmful outcome. r Only use samples from anticoagulant tube right after blood sampling. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 54 The test strip port light turns blue: test strip is recognized and checked. Then, it turns white: instrument is ready for sample application. The instrument beeps. f The instrument runs checks and notifies you of any issues. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 55 If it does not, gently shake the instrument to help test strip to fall out. Cleaning and disinfecting details and procedure in the chapter: u Cleaning and disinfecting the instrument Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 56 Within normal range f The Eject test strip screen appears. No comments u Related topics • Entering insulin information (88) • Adding comments to a test result (57) Confirm Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 57: Adding Comments To A Test Result

    Local results screen. For example, when an error Cancel Save was made while running a test (dirt on the hand). The result is still transmitted to DMS (flagged as invalid). Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 58: Reviewing Patient Test Results

    3 To search for a patient’s result, you can: • Tap the tab, and then scan the barcode of the patient. • In the tab, enter the patient ID or name with the keyboard. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 59 Test details screen. Date of birth • Tap the button to return to the Local results Gender screen. Glucose mmol/L Within normal range No comments Test strip lot number Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 60: Running A Qc Test

    The procedures for running Level 1 and Level 2 tests are the same. Colored test strip port light provides guidance of instrument statuses / actions you must take. Intervals between running QC tests are determined by your healthcare facility. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 61 QC lot number barcode. • On the 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 · User Guide · Publication version 3.0...
  • Page 62 If it does not, gently shake the instrument to help test strip to fall out. Cleaning and disinfecting details and procedure in the chapter: u Cleaning and disinfecting the instrument Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 63 • In case of FAIL repeat the QC test. • If it fails again please contact your system administrator. Confirm u Related topics • Adding comments to a test result (57) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 64: Reviewing Qc Test Results

    Unknown patient 16.7 mmol/L 999999999 22-Mar-2020, 16:31 Glucose Jenny Doe mmol/L 1234567890 22-Mar-2020, 15:27 Glucose John Doe mmol/L 123123123 22-Mar-2020, 15:27 Glucose Jenny Doe mmol/L 1234567890 22-Mar-2020, 15:27 Glucose Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 65 1 On the navigation bar, tap the button to enter the Local results screen. 2 Tap the QC results tab. 3 Tap the result you want to view. f The Result details screen opens. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 66 QC level 1 screen. Glucose 22-Mar-2020, 16:31 • Tap the button to return to the QC results tab. PASS Passed No comments QC lot number 99999999 Test strip lot number 567890 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 67: Putting The Instrument Into Standby Mode

    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. The instrument vibrates. f The instrument goes into standby mode. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 68: Waking The Instrument From Standby Mode

    To wake the instrument from standby mode 1 Press the on/off button firmly. The instrument vibrates. f The instrument wakes from standby mode. f The Glucose screen or the app library appears. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 69: Logging Off From 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 Notifications screen, tap the button. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 70 Logging off from the Glucose app Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 71 Settings app ........Running a linearity test..........Running an emergency glucose test ......Running an observed test sequence (OTS) ....Entering insulin information........Turning off the instrument.......... Restarting the instrument .......... Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 72 Table of contents Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 73: Unpacking The Instrument

    1 Place the instrument in the charging station. f Hibernation mode is removed and the instrument is ready for use. 2 If necessary leave the instrument to charge in the charging station. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 74: 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 · User Guide · Publication version 3.0...

  • Page 75: Turning On The Instrument

    • Place the instrument in the charging station. In each case the instrument beeps. f The splash screen appears. Then, the Glucose screen or the app library appears. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 76: Changing Your User Password

    An error message notifies you when the passwords you enter do not match. Cancel Save 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 · User Guide · Publication version 3.0...

  • Page 77: Adjusting The Screen Brightness And The Volume In The Glucose App

    Brightness and volume 3 To adjust the volume, move the Volume slider. Brightness When you stop moving the slider, the instrument beeps to show the chosen volume setting. Volume Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 78: Adjusting The Screen Brightness And The Volume Level Using The Settings App

    • To decrease the volume level, move the Volume slider to the left. Alternatively, tap the button. When you stop moving the slider, the instrument emits an audible signal, indicating the volume level for that setting. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 79: Running A Linearity Test

    • Scan the linearity kit lot barcode. • If enabled, tap the tab and then below Choose linearity kit lot, tap the lot you will use to run the test. Linearity Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 80 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 · User Guide · Publication version 3.0...
  • Page 81 8 To perform the second run for the level 1 test, repeat Glucose steps 4 to 7. f The result of the second run is displayed. mmol/L Passed Linearity kit lot number Test strip lot number Proceed Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 82 You can view the test result at any time in Local All levels passed results > QC results. No comments u Related topics Linearity kit lot number • Reviewing QC test results (64) Test strip lot number Confirm Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 83: Running An Emergency Glucose Test

    New pair of disposable gloves m Waste container m You are logged on to the instrument. m Your instrument is configured to run emergency glucose tests. Logging on to the Glucose app (46) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 84 Follow the remaining time on the screen. When enough sample is applied, the test strip port light turns blue and the instrument beeps. f The test is processed and the Result screen appears. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 85 Cleaning and disinfecting details and procedure in the chapter: u Cleaning and disinfecting the instrument u Related topics • Entering insulin information (88) • Adding comments to a test result (57) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 86: Running An Observed Test Sequence (Ots)

    • Run 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. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 87 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. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 88: 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 · User Guide · Publication version 3.0...
  • Page 89 After making the change, tap the Next button to return to the Rapid-acting insulin current screen. Regular insulin Intermediate-acting insulin Long-acting insulin Insulin mixtures Previous Next Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 90 Next button. Comments 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 · User Guide · Publication version 3.0...
  • Page 91 Time require associated entries to be changed. Insulin type u Related topics • Running a glucose test (53) Insulin name • Entering a patient (50) Insulin units Comments Confirm Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 92: Turning Off The Instrument

    1 Press and hold the on/off button until the Power off / Restart menu appears. The instrument makes regular beeps. 2 Tap the Power off option. f The splash screen appears and the instrument turns off. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 93: Restarting The Instrument

    2 Tap the Restart option. f The splash screen appears and the instrument restarts. f The splash screen appears again. Then, the Glucose app screen or the app library appears. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 94 Restarting the instrument Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 95 Maintenance Maintenance ..................  97 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 96 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 97 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....Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 98 Table of contents Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 99: About Cleaning And Disinfecting The Instrument

    Only use cleaning solutions and disinfectants recommended by Roche. Instrument cleaning status This notification indicates that either: •...
  • Page 100 About cleaning and disinfecting the instrument u Related topics • Acceptable cleaning solutions and disinfectants (101) • Cleaning and disinfecting the instrument (102) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 101: Acceptable Cleaning Solutions And Disinfectants

    55% ® (e.g., Super Sani-Cloth u Related topics • About cleaning and disinfecting the instrument (99) • Cleaning and disinfecting the instrument (102) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 102: Cleaning And Disinfecting The Instrument

    Between each patient m Disposable gloves m Soft, lint-free cloth or gauze m Premoistened wipes for cleaning and disinfection or cleaning solutions and disinfectant. Acceptable cleaning solutions and disinfectants (101) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 103 (with water). 6 After cleaning and disinfecting, if required: Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 104 Instrument cleaning dialog box, tap the Confirm button to confirm that the device has been cleaned and disinfected. u Related topics • About cleaning and disinfecting the instrument (99) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 105: Station

    • After cleaning, dry the charging station with a lint- free cloth or gauze. • For disinfection, observe surface contact time in line with the disinfectant guidance. 4 Plug in the charging station. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 106: Cleaning And Disinfecting The Carry Case

    • For disinfection, observe surface contact time in line with the disinfectant guidance. Make sure no solution is in the carry case after cleaning/disinfecting. f You can now place the everything back inside. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 107 Troubleshooting Troubleshooting ................ 109 Error messages................ 121 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 108 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 109 Resetting the instrument..........Starting up an instrument with low battery level..Running a network status test........Network status test steps .......... Anonymizing all instrument data ........ List of audit trail events..........Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 110 Table of contents Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 111: Resetting The Instrument

    > Administrator > Reset instrument. f The Reset instrument dialog box is displayed, explaining the implications of confirming. 2 In the Reset instrument dialog box, tap the Confirm button. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 112: Starting Up An Instrument With Low Battery Level

    2 When the battery charge is enough, leave the instrument in the charging station, then press the on/ off button. f The instrument starts up. u Related topics • Charging the instrument (45) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 113: Running A Network Status Test

    Network status test steps (115) r To run a network status test 1 Tap > Instrument information > Network status test. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 114 Network status test f 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 · User Guide · Publication version 3.0...

  • Page 115: Network Status Test Steps

    Wi-Fi activated 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...
  • Page 116  Network status test steps Running a network status test (113) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 117: Anonymizing All Instrument Data

    The following information remains on the instrument: • Measured glucose values • Results entered via the OTE app The following instrument configuration values are updated (to enable Roche Service representatives to access the instrument): • User authentication required is set to Disabled •...
  • Page 118 The encryption method uses the Advanced Encryption Standard (AES) with a key length of 256 bits. Roche does not have access to the encryption key (the encryption key is erased after the completion of the encryption) and will under no circumstances try to reverse the encryption.

  • Page 119: List Of Audit Trail Events

    Instrument turned off. Software update was performed. Software configuration: <SW_configuration>. Self-check was passed. QC lockout occurred. Synchronization lockout occurred. Incorrect password delay. y  Audit trail events u Reviewing the audit trail Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 120 List of audit trail events Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 121 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 .......... Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 122 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 ......Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 123: About Errors And Messages

    2 errors. A Level 1 message contains: • Message code (e.g., U-AN) • Title • Problem • Guidance Level 1 messages use the following formats: Information Warning Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 124 (e.g., T-AB). Group Issue type Hardware Sample Strip/instrument User Environmental condition System software Glucose app y Error messages groups Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 125 Audit trail details screen appears containing the level 2 T-AB RFID timeout error code. Date and time 22-Mar-2020, 15:27 Description Reading period has timed out. Ensure sufficient proximity. CA-0031 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 126: Error Messages

    G-AE: Instrument error (133) H-AC: Low battery (134) H-AF: Date/time lost (134) H-AG: Ejection error (134) H-AJ: Battery version error (134) I-AC: Software update error (135) I-AE: Encryption error (135) I-AF: Software update error (135) I-AG: Synchronization failed (136) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 127: B-Aa: Invalid Barcode

    Barcode is invalid. Try again. If the problem persists, contact your system administrator. Severity Error Critical About errors and messages (123) B-AB: Scan timeout Scanning period has timed out. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 128: B-Ac: Wrong Sequence

    Check barcode configuration content. Severity Error Note About errors and messages (123) C-AA: Database full Ensure that the instrument is connected to the network. Severity Error Critical About errors and messages (123) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 129: C-Ab: Database Error

    Warning Critical About errors and messages (123) D-AB: Lot expired Repeat the test with a test strip from a valid lot. Severity Warning Warning About errors and messages (123) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 130: D-Ae: Material Expired

    About errors and messages (123) D-AH: Unknown lot Ensure that a correct test strip lot is used. Try again. If the problem persists, contact your system administrator. Severity Warning Warning Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 131: D-Aj: Qc Test Required

    Repeat the test with a new test strip. Do not remove the test strip during processing. Severity Warning Note About errors and messages (123) D-AN: Unknown kit lot Unknown kit lot. Severity Warning Note Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 132: D-Ao: Test Strip Error

    Try again. If the problem persists, contact your system administrator. Severity Error Critical About errors and messages (123) E-AB: Temperature too high Testing not possible. Use the instrument at a lower temperature. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 133: G-Aa: Instrument Error

    Try again. If the problem persists, contact your system administrator. Severity Warning Warning About errors and messages (123) G-AE: Instrument error Action is not possible. Severity Warning Warning About errors and messages (123) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 134: H-Ac: Low Battery

    Critical About errors and messages (123) H-AJ: Battery version error Due to the nature of this issue, only the ID (H-AJ) of the message is displayed on the screen. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 135: I-Ac: Software Update Error

    Error messages Incompatible battery detected. The instrument cannot be used. Contact your Roche representative. u Replacing the battery About errors and messages (123) I-AC: Software update error Instrument cannot be used. Ensure that the instrument is connected to the network.

  • Page 136: I-Ag: Synchronization Failed

    Warning About errors and messages (123) S-AB: Sample application error Repeat the test with a new test strip. Apply sufficient sample when requested without moving the test strip. Severity Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 137: S-Ad: Sample Type Error

    T-AA: Invalid RFID tag Read a correct RFID tag. Severity Error Warning About errors and messages (123) T-AB: RFID timeout Reading period has timed out. Ensure sufficient proximity. Severity Warning Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 138: U-Aa: Invalid User Id

    U-AC: Patient not found Patient ID was not found. Severity Error Warning About errors and messages (123) U-AD: Invalid observer Invalid observer. Severity Error Note About errors and messages (123) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 139: U-Ae: Invalid Patient Id

    Critical About errors and messages (123) U-AG: Unexpected bottle Scan bottle: QC, Level 1 or Scan bottle: QC, Level 2 Scan the requested bottle again. If the problem persists, contact your Roche representative. Severity Warning Note About errors and messages (123) U-AJ: User not found User was not found.

  • Page 140: U-Ak: Patient Not Found

    About errors and messages (123) U-AN: Inconsistent insulin value Value must be greater than 0 and less than 50 (maximum one decimal place). Severity Error Note About errors and messages (123) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...

  • Page 141: U-Ao: Invalid Sample Id

    U-AP: Invalid sample ID Sample ID is invalid. Severity Error Note About errors and messages (123) U-AQ: Insufficient user rights Action is not allowed. Severity Error Note About errors and messages (123) Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 142 Error messages Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 143 Corrosive oxidizing disinfectant and bleaching agent. Process to eliminate most pathogenic microorganisms without neccesarily killing or removing all organisms (e.g., bacterial spores). Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 144 Lockout that occurs in case of a QC error or a due QC behind when used. test. malicious software QC lot Software that fulfills the deliberately harmful intent of Lot of a QC material. an attacker when run. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 145 ID Roche Service representative ID to identify a test strip. Roche representative who may install instruments and/ or perform preventive maintenance and/or service test strip lot activities. Lot of test strips.
  • Page 146 Page intentionally left blank. Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 147 Glucose app, 46 Glucose test, 53 Safety classifications, 19 Safety precautions, 20 Screenshot disclaimer, 3 Instrument Standby mode, 67, 68 – Anonymize all data, 117 System, 33 – brightness, 77, 78 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 148 – glucose test, 53 – linearity test, 79 – observed test sequence (OTS), 86 – patient test results, 58 – QC test, 39, 60 – QC test results, 64 Warranty, 3 Roche Diagnostics cobas® pulse · User Guide · Publication version 3.0...
  • Page 149 Page intentionally left blank.
  • Page 150 Published by Roche Diagnostics International Ltd CH-6343 Rotkreuz Switzerland www.roche.com...

Table of Contents

Save PDF