Roche cobas e 411 Manual
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Roche cobas e 411 Manual

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cobas e 411 analyzer
Safety Manual
Version 1.2
Software Version 03-01

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Summary of Contents for Roche cobas e 411

  • Page 1 411 analyzer Safety Manual Version 1.2 Software Version 03-01...
  • Page 2 Always leave software updates to a Roche Service representative or perform such updates with their assistance. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 3 Outside the European Union and EFTA member states Manufactured by: Hitachi High-Technologies Corporation Manufactured for: Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 4: Table Of Contents

    Barcode reader ......Safety information for disposal ....Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 5: Preface

    Duration of a task Materials that are required for a task Prerequisites of a task Topic. Used in cross-references to topics. y Symbols used in the publication Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 6 Amplification and Detection ANSI American National Standards Institute Canadian Standards Association European Community GNU’s Not Unix European Standard International Electrical Commission In Vitro Diagnostic y Abbreviations Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 7 Standard Deviation 13 mm sdta 13 mm sample disk tube adapter Standard Operating Procedure Underwriters Laboratories Inc. WEEE Waste Electrical and Electronic Equipment y Abbreviations Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 8: Introduction

    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 e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 9: 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 e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 10: Safety Precautions

    Follow good laboratory practices and regularly change lab gloves to minimize the risk of infection and contamination, especially after contact with waste or sample material. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 11 Do not exchange or remove any part of the analyzer. r Leave replacement of analyzer parts to trained Roche Service representatives. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 12 Do not use consumables that are not intended for use with the system. u For a list of supported materials, see the user documentation. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 13: Miscellaneous Safety Precautions Overview

    For further information, call your Roche Service representative. 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 e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 14: Warning Messages

    Set the main circuit breaker switch to OFF, then remove all power supply cords. Rack systems can have more than one power supply cord. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 15: Biohazardous Materials

    Do not touch any parts of the system other than those specified. r Never reach into the analyzer while parts are moving. r Carefully observe all instructions given in this safety manual. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 16: Waste

    If waste comes into contact with your skin, wash the affected area immediately with soap and water and apply disinfectant. Consult a physician. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 17 Take extra care when pouring ProCell and CleanCell down the drain, as they may produce toxic gases. Run the tap continuously to ensure that the waste is diluted. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 18: Caution Messages

    Do not touch the touchscreen monitor if it is visibly damaged. r Contact your Roche Service representative. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 19 A-Line or unload samples from the C-Line. r Do not add or remove single AssayCups and AssayTips to a tray when it is on the analyzer. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 20: Reagents And Other Working Solutions

    Ensure good sample preparation and reagent handling techniques to avoid the formation of foam, clots, and bubbles in all reagents, samples, and controls. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 21 Traces of analytes or reagents may be carried over from one test to the next. r Take adequate measures, for example, extra wash cycles, to avoid extra testing and potentially incorrect results. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 22: Fatigue Due To Long Hours Of Operation

    Wireless interference Wireless devices in the analyzer may lead to malfunction. r Do not leave mobile phones or other wireless devices inside the analyzer. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 23: Data Security

    If a message from the operating system on the PC indicates a problem with the flash memory, then contact your Roche service representative. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 24: Notices

    Avoid heat sources close to the system. u See the system specifications in the user documentation for the allowable environmental conditions. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 25: Incorrect Results

    Opening the detection unit cover while the power is on can damage the photomultiplier. r Power off the analyzer before attempting to open the detection unit cover. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 26 If liquid does spill on the system, wipe it up immediately and follow the applicable decontamination procedure. Wear appropriate personal protective equipment. Dispose of waste according to the local regulations. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 27: Safety Labels On The System

    Laser transmitter There is a danger of contact with laser light or severe damage to the eyes. Do not stare into the laser transmitter. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 28 When working with the system, observe both the safety labels on the system and the safety messages in the user documentation. Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 29: Location Of Safety Labels On The System

    Location of safety labels on the system w Safety labels on the analyzer unit (disk system) w Safety labels on the analyzer unit (rack system) Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 30 Safety labels on the system w Safety labels on the solid waste tray and Clean-Liner w Safety labels on the circuit breaker of the analyzer Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 31 Safety labels on the system w Safety labels on the rack sampler circuit breaker Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 32: Safety Information For Lasers

    Remark 650 nm 10-30 V(DC) 0.81 mW Class 1 laser 655 nm 10-30 V(DC) 1.7 mW Class 2 laser y Lasers on the system Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

  • Page 33: Safety Information For Disposal

    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 e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...
  • Page 34 Safety information for disposal Roche Diagnostics cobas e 411 analyzer · Software Version 03-01 · Safety Manual · Version 1.2...

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