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Summary of Contents for Roche cobas c 513
- Page 1 513 analyzer Safety Manual – Version 6.0 Software Version 02-05 (01)07613336187722(8012)02-05...
- Page 2 The content is organized according to the normal operation workflow. ® cobas e-library provides access to important updates, Method Sheets, Value Sheets, and other important documents from Roche. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 3 For conditions of warranty, contact your local sales representative or refer to your warranty contract partner. Always leave software updates to a Roche Service representative or perform such updates with their assistance. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 4 513 analyzer. Trademarks The following trademarks are acknowledged: COBAS and COBAS C are trademarks of Roche. All other trademarks are the property of their respective owners. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 5 All documents are available under eLabDoc on the Roche DiaLog website: www.dialog.roche.com. If you are unable to access Roche DiaLog, contact your Roche Service representative. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 6 • IEC 61010-1 • IEC 61010-2-101 The analyzer complies with the emission and immunity requirements described in the standard IEC 61326-2-6 / EN 61326-2-6. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 7 Electronic user documentation can be downloaded under eLabDoc on the Roche DiaLog website: www.dialog.roche.com For more information, contact your local affiliate or Roche Service representative. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 8: Table Of Contents
Barcode reader ......Safety information for disposal ....Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 9: Preface
The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only). Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 10: Symbols And Abbreviations
Symbols used on products Symbol Explanation Global Trade Item Number Consult instructions for use on this website: www.dialog.roche.com Quantity contained in the package y Symbols used on products Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 11 Unique device identifier Indicates that the equipment is suitable for alternating current only. Catalogue number Lot number Single use y Symbols used on products Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 12 General Data Protection Regulation GNU’s Not Unix! Hospital information system International Electrotechnical Commission IFCC International Federation of Clinical Chemistry and Laboratory Medicine In vitro diagnostic y Abbreviations Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 13 HbA1c batches (D3) Standard deviation SmpCln 1 Basic sample probe wash solution STAT Short turn-around time Universal serial bus WEEE Waste Electrical and Electronic Equipment y Abbreviations Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 14: 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 15: 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 16: 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 17 Do not exchange or remove any part of the analyzer that is not described in the user documentation. r Leave replacement of parts not described in the user documentation to trained Roche Service representatives. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 18: Miscellaneous Safety Precautions Overview
Perform regular backup of results and system parameters. r Do not switch off power while the control unit accesses the hard disk or storage device. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 19 For further information, contact 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 20: About The Protection Of Personal Data And Software Security
If you ever disclose your password to anyone, change it immediately afterwards. r Contact your local Roche affiliate if you think your account has been compromised. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 21 Do not take storage media outside the lab environment. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 22 If you think your PC is infected with a computer virus, call your local Roche Service representative. Your local Roche Service representative will check your system for proper functionality. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 23 Roche Service representative advises r Do not change any PC settings. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 24: Warning Messages
Your personal protective equipment should be appropriate to the degree and type of potential hazard, e.g. suitable lab gloves, eye protection, lab coat, and footwear. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 25: Electrical Safety
Do not remove any cover of the system except those specified in the user documentation. r Leave maintenance, installation, or service that is not described to trained Roche Service representatives. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 26: Biohazardous Materials
If sample or 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 27: Reagents And Other Working Solutions
Ensure good sample preparation and reagent handling techniques to avoid the formation of foam, clots, and air bubbles in all reagents, samples, calibrators, and controls. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 28 Overfilling of sample containers may cause splashing of the sample during transportation. r Leave approximately 10 mm clearance between the sample liquid and the top of the tube or cup. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 29 Load sample tube types in the correct rack ranges. For more information about sample containers, see the list of sample container specifications in the Operator’s Manual or User Assistance. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 30: Maintenance
Do not overfill sample tubes. r 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 31 For the legal regulations on water discharge, contact the reagent supplier. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 32: Caution Messages
Do not touch the touchscreen monitor if it is visibly damaged. r Contact your Roche Service representative. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 33: Reagents And Other Working Solutions
When you use alcohol on or around the analyzer, use no more than 20 mL at a time. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 34: External Media
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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 35: Notices
PC to stop blinking. r Before you remove a USB flash storage device, safely remove the device from the system. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 36 Shock, vibration, or pressure can damage the analyzer. stress r Keep sources of vibration away from the analyzer. r Do not place objects on the system. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 37: Electromagnetic Interference
Cordless phones 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 38: Emergency Stop
The CU circuit breaker removes power from the control unit. If there is an internal failure of the system, the circuit breakers self-release. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 39: Safety Labels On The System
Observe relevant good laboratory practices on safe usage. Corrosive materials There is a danger of contact with corrosive or caustic material. Wear appropriate personal protective eye protection and gloves. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 40 When working with the system, observe both the safety labels on the analyzer and the safety messages in the user documentation. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 41: Location Of Safety Labels On The Analyzer
Warning labels are placed on the analyzer to draw your attention to areas of potential hazard. w Safety labels in the sample area of the analytical unit Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... - Page 42 Safety labels on the system w Safety labels in the reaction disk area of the analytical unit w Safety labels at the front of the sampler unit Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 43 Safety labels on the system w Safety labels behind the front service doors of the analytical unit w Safety labels underneath the reaction disk of the analytical unit Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
- Page 44 Safety labels at the rear of the analytical unit, liquid waste containers w Safety labels at the rear of the analytical unit, refrigeration unit Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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Page 45: Safety Information For Lasers
Do not remove covers from barcode readers. r Do not perform any maintenance actions on barcode readers. If a problem with a barcode reader occurs, then contact your Roche service representative. Roche Diagnostics cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0... -
Page 46: 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 c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0...
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