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Roche cobas t 511 Safety Manual
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Roche cobas t 511 Safety Manual

Roche cobas t 511 Safety Manual

Coagulation analyzer
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cobas t 511 coagulation analyzer
Safety Guide version 5.0
Software version 2.2

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Summary of Contents for Roche cobas t 511

  • Page 1 511 coagulation analyzer Safety Guide version 5.0 Software version 2.2...
  • Page 2 However, the manufacturer of this product may need to update the publication information as output of product surveillance activities, leading to a new version of this publication. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 3 Viewing events are analyzed to improve User Assistance content and search functionality. IP addresses are used to classify regional behavior. Copyright © 2017–2021, F. Hoffmann-La Roche Ltd. All rights reserved. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 4 Electronic user documentation can be downloaded using the eLabDoc e-service on Roche DiaLog: www.dialog.roche.com For more information, contact your local affiliate or Roche Service representative. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 5 Disposal information ......Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 6 511 coagulation analyzer. Insert Sarstedt 8 mm Tube Rack insert to handle small volume sample tubes on the cobas t 511 coagulation analyzer. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 7 Radio Interference) Federal Communications Commission International Electrotechnical Commission International Organization for Standardization In vitro diagnostic IVDR In vitro diagnostics regulation Standard Operating Procedure y Abbreviations Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 8 Keep this publication in a safe place to ensure that it is not damaged and remains available for use. This publication must always be easily accessible. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 9 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 t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 10 Using the instrument in a way not described by the manufacturer, can impair the protection provided. r Do not use the analyzer in a way that is not described in the user instructions. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 11 See section Cleaning and decontamination in the user documentation. Errors in installation Only trained Roche Service representatives may install the system. r Leave installation that is not described to trained Roche Service representatives. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 12 Do not use consumables that are not intended for use with the analyzer. u For a list of supported materials, see the user documentation. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 13 Damage in transit r Do not attempt to relocate or transport the system. r Leave relocation and transportation to Roche Service representatives. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 14 Roche assumes no responsibility for the correctness of user-defined tests. • When adding additional dilutions to a test, you must manually validate and release the results. u Related topics • Disposal information (41) Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 15 Only Roche Service representatives are permitted to install, service, and repair the system. u Related topics • List of safety labels on the analyzer (33) Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 16 Wear appropriate personal protective equipment. Take extra care when working with lab gloves. They can easily be pierced or cut, leading to infection. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 17 Always follow the troubleshooting procedures given in software wizards and/or in the user documentation. r Wear appropriate personal protective equipment when implementing corrective measures. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 18 Keep away from moving parts during operation. r During operation and maintenance, carefully follow the instructions. r Observe all safety labels on the analyzer. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 19 Make sure that the samples contain no insoluble contaminants, such as fibrin or dust. r Ensure that no air bubbles are aspirated into the sample pipetting mechanism. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 20 System water leakage in sample pipetting System water leakage in the sample pipetting mechanism mechanism can lead to incorrect results. r Regularly perform QCs and visual checks for system water leakage. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 21 Incorrect results due to hemolysis, icterus, The presence of hemoglobin, bilirubin, and lipids in the and lipemia sample can affect the result quality. r Ensure good sample preparation and handling techniques. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 22 Sample tube filling volume Incorrect filling volume can lead to incorrect results. r Perform a visual check to ensure correct sample tube filling volume. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 23 Do not attempt to empty and reuse solid waste bags. r When disposing of solid waste, dispose of the entire bag. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 24 Avoid shutting off the main power switch while the analyzer is operating. r Take care when restarting or reinitializing the system. r Regularly backup database. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 25 Do not write any patient sensitive information into the following fields: Sample-level comments Result-level comments QC result comments Calibration result comments Calibration measurement point comment Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 26 Use caution if condensation water is present. r Take measures to prevent any condensation water from accumulating on the floor. u Related topics • List of safety labels on the analyzer (33) Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 27 Incorrect results due to reuse of consumables Reuse of consumables can lead to contamination, resulting in a false positive result. r Do not reuse consumables. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 28 Looking at the monitor over an extended time may lead to eye strain or body fatigue. r Take a break to relax, in accordance with your laboratory's SOPs or local regulations. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 29 Make sure that system backup and archive files are physically secured and are protected from any unauthorized access and disaster. This includes: remote storage location; disaster recovery sites; secure transfer of backup files. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 30 CISPR 11 Class A. In a domestic environment this may cause radio interference, in which case you may need to take measures to mitigate the interference. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 31 Maintenance Log off during maintenance Logging off during maintenance can lead to system errors. r Do not log off or shut down the analyzer during maintenance. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 32 Disconnecting external storage devices from the system during writing process can lead to data loss. r Only disconnect external storage devices after performing the safe removal process on the operating system. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 33 Refer to the user documentation for instructions on safe operation. Biohazard Potentially biohazardous materials are used near this label. Observe relevant laboratory best practices on safe usage. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 34 When working with the system, observe both the safety labels on the system and the safety messages in the user documentation. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 35 Risk of damage to the analyzer or spillage due to overheight tube. r Only use specified tubes. r Place the tubes containing the calibrator, QC, or sample into the appropriate racks. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 36 Safety labels on the analyzer w Rack platform w Front panel Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 37 Safety labels on the analyzer w Reagent cassette drawer w Water/liquid waste drawer Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 38 The system water must be reagent grade or higher, and meet the following specifications: r Conductivity: ≤1.0 μS/cm at 25°C r Microbiological impurities: ≤ 100 CFU/ml w Solid waste door w Waste tray Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 39 Never replace the System Cleaner bottle while the analyzer is operating. Rack loading area Labeling: Supported racks Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 40 Water container Labeling: Water label WARNING The water container is labeled so that only reagent grade water or higher is used. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 41 It is left to the responsible laboratory organization to determine whether electronic equipment components are contaminated or not. If contaminated, treat them in the same way as the system. Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...
  • Page 42 Safety information for disposal Roche Diagnostics cobas t 511 coagulation analyzer · 2.2 · Safety Guide · 5.0...