Roche Cobas p 512 Bedienungsanleitung

cobas p 512 pre-analytical instrument

Operator’s Manual

cobas p 512

II Operator's Manual - Version 1.6 - 10/2015

cobas p 512

Operator's Manual - Version 1.6 - 10/2015 III

Manual version

Version

Creation date

1.0

June 2007

1.1

February 2008

1.3

September 2011

1.3.1

February 2012

1.3.2

April 2013

1.4

December 2013

1.5

February 2014

1.6

October 2015

Intended use

The cobas p 512 pre-analytical system and cobas p 512 CCM variant pre-analytical system

are computer controlled fully automatic systems for sorting of open and closed barcoded and

centrifuged sample tubes as well as decapping and recapping of such.

They further include modules for registration of barcoded sample tubes, liquid level and

sample quality detection.

In case of standalone use of the cobas p 512 pre-analytical system, the transfer of tubes,

processed on the cobas p 512 pre-analytical system, to any other workstation within the

laboratory is subject of validation performed by the laboratory itself.

Software compatibility

The Operator's Manual has been written for the cobas p 512 with software version 1.6.1 or

higher.

Copyrights

This manual is a product of Roche PVT GmbH.

All rights are reserved. No part of this manual may be reproduced in any form (print,

photocopy, microfilm or another procedure) or processed using electronic systems, copied

or distributed without the written permission of the company.

The company assumes no liability for any errors, omissions or damages resulting from the

use of the information contained in this manual.

Note: All of the product names contained in this manual are trademarks of the respective

companies. If the trademark symbols © or ® are not included, it cannot be assumed that the

name is an unregistered product name.

The content of this manual is subject to change without any communicative obligations by

the company.

cobas p 512

IV Operator's Manual - Version 1.6 - 10/2015

Norms and standards

The cobas p 512 sorting system conforms to the currently applicable directives of the

European Union. Compliance with all standards and legal obligations is guaranteed.

CE labeling corresponds to the EU directives 98/79/EU (IVD Directive).

The requirements, limits and tolerances stated in the following standards are complied with:

•DIN EN 61326 (EMC requirements for electrical laboratory instruments)

•DIN EN 61010-1 (Safety requirements for electrical laboratory instruments)

•DIN EN 60825-1 (Safety requirements for laser equipment)

The instrument complies with

IVD Directive 98/79/EC

Guarantee and warranty

Current guarantee information can be found in your purchase contract or by asking at your

appointed dealer.

Neither Roche PVT GmbH nor its subsidiaries assume any liability to the purchaser of this

product or any third parties for damages, losses, costs or expenses incurred by the purchaser

or third parties due to accident, misuse of the product or unapproved modifications, repairs

or improvements to the instrument.

Roche PVT GmbH assumes no liability for damages or disruptions resulting from the use of

options or accessories that are not original products or that do not have express approval

from Roche PVT GmbH.

Contact address

Manufacturer

Roche Diagnostics GmbH

Roche Professional Diagnostics

Sandhofer Strasse 116

-68305 Mannheim

Germany

cobas p 512

Operator's Manual - Version 1.6 - 10/2015 V

Table of contents

1. General information..............................................................................1-1

1.1. Preface..........................................................................................................1-1

1.2. Using the Operator’s Manual ...................................................................1-1

1.3. Screen graphics, signs and symbols ...................................................... 1-1

1.4. Abbreviations............................................................................................... 1-1

1.5. Hazards and precautionary measures ...................................................1-1

1.5.1 Safety instructions ........................................................................................................1-1

1.5.2 Warning labels on the unit ........................................................................................1-1

1.5.3 Notes on safety ..............................................................................................................1-1

1.5.4 Electrical safety ..............................................................................................................1-1

1.5.5 Samples.............................................................................................................................1-1

1.5.6 Laser exposure...............................................................................................................1-1

1.6. Preconditions for scanning a barcode................................................... 1-1

1.6.1 Barcode quality, printing and labeling material ................................................1-1

1.6.2 Specifications for the barcode labels....................................................................1-1

1.6.3 Placement of the barcode label...............................................................................1-1

1.6.4 Sample images of correct and incorrect barcode labels...............................1-1

1.7. Disposal of device ...................................................................................... 1-1

1.7.1 Information on Waste of Electrical and Electronic Equipment (WEEE)....1-1

2. System description ...............................................................................2-1

2.1. Introduction.................................................................................................. 2-1

2.1.1 Operator training...........................................................................................................2-1

2.1.2 Customer configuration..............................................................................................2-1

2.1.3 Specifications..................................................................................................................2-1

2.1.4 Level of automation......................................................................................................2-1

2.1.5 Device reliability.............................................................................................................2-1

2.2. Hardware description ................................................................................ 2-1

2.2.1 Schematic diagram.......................................................................................................2-1

2.2.2 System safety devices..................................................................................................2-1

2.2.3 Control unit......................................................................................................................2-1

2.2.4 QNX Computer...............................................................................................................2-1

2.2.5 QS I computer (optional)............................................................................................2-1

2.2.6 Input sorter ......................................................................................................................2-1

2.2.7 Tube transport (RT-Transport).................................................................................2-1

2.2.8 Tube recognition ...........................................................................................................2-1

2.2.9 Infrared liquid level detection (IR-LLD)................................................................2-1

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VI Operator's Manual - Version 1.6 - 10/2015

2.2.10 Laser liquid level detection (Laser-LLD)..............................................................2-1

2.2.11 Decapping module .......................................................................................................2-1

2.2.12 Recapping module (optional)...................................................................................2-1

2.2.13 Output sorter...................................................................................................................2-1

2.2.14 Signal lamp......................................................................................................................2-1

2.2.15 Operating modes...........................................................................................................2-1

2.2.16 Mains connection and system interfaces............................................................2-1

2.2.17 Compressed air connection ......................................................................................2-1

2.2.18 The waste container for the decapping module ...............................................2-1

2.2.19 Air pressure maintenance unit (interior)..............................................................2-1

2.3. Consumable material.................................................................................2-1

2.3.1 Sealing foils (optional) ................................................................................................2-1

2.4. Accessories..................................................................................................2-1

2.4.1 Carriers, racks and rack trays...................................................................................2-1

2.4.2 Compressor .....................................................................................................................2-1

2.4.3 Cleaning brush...............................................................................................................2-1

2.4.4 Cleaning sets ..................................................................................................................2-1

2.5. Sample flow and sample processing ..................................................... 2-1

2.5.1 The route that the sample takes through the system .....................................2-1

2.5.2 Processing profiles and priorities............................................................................2-1

2.5.3 Defining sorting racks.................................................................................................2-1

2.5.4 Processing open sample tubes................................................................................2-1

2.5.5 Processing recursive sample tubes........................................................................2-1

2.5.6 Processing multiple patient samples with the identical barcode ...............2-1

2.5.7 Archiving the sample tubes ......................................................................................2-1

2.6. Basic information about the software....................................................2-1

2.6.1 Structure of the software ...........................................................................................2-1

2.6.2 QNX operating system ................................................................................................2-1

2.6.3 Communication with the laboratory host computer........................................2-1

2.6.4 Graphic user interface.................................................................................................2-1

2.6.5 How to use the menu system...................................................................................2-1

2.6.6 Online Help......................................................................................................................2-1

2.6.7 System status and messages....................................................................................2-1

2.6.8 Error messages...............................................................................................................2-1

2.7. Software description.................................................................................. 2-1

2.7.1 Login and user rights...................................................................................................2-1

2.7.2 System test.......................................................................................................................2-1

2.7.3 Log out / shut down system .....................................................................................2-1

2.7.4 Structure of the menus ...............................................................................................2-1

2.7.5 Routine menu .................................................................................................................2-1

2.7.6 Routine – Control ..........................................................................................................2-1

2.7.7 Routine menu – Sorting lists.....................................................................................2-1

2.7.8 Routine menu – Information system......................................................................2-1

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Operator's Manual - Version 1.6 - 10/2015 VII

2.7.9 Routine menu – Clear Data.......................................................................................2-1

2.7.10 Routine menu – Statistics ..........................................................................................2-1

2.7.11 Maintenance menu ......................................................................................................2-1

2.7.12 Maintenance menu – Error history.........................................................................2-1

2.7.13 Maintenance menu – Daily Backup.......................................................................2-1

2.7.14 Maintenance menu – Date, time, day ...................................................................2-1

3. Operation.................................................................................................3-1

3.1. Commissioning the system ...................................................................... 3-1

3.2. Daily routine................................................................................................. 3-1

3.2.1 Trouble-free operating procedures........................................................................3-1

3.3. Preparation................................................................................................... 3-1

3.3.1 Emptying the waste container..................................................................................3-1

3.3.2 Emptying the condensation container ..................................................................3-1

3.3.3 Inserting sealing foils for the recapper (optional)............................................3-1

3.3.4 Switching the system on ............................................................................................3-1

3.3.5 Login ..................................................................................................................................3-1

3.3.6 System test.......................................................................................................................3-1

3.3.7 Performing a reorganization .....................................................................................3-1

3.3.8 Selecting the work cycle (optional)........................................................................3-1

3.3.9 Loading the system ......................................................................................................3-1

3.4. Operation......................................................................................................3-1

3.4.1 Start sample processing.............................................................................................3-1

3.4.2 Interrupt sample processing .....................................................................................3-1

3.4.3 React to error messages.............................................................................................3-1

3.4.4 Input sorter during operation, with loaded samples, racks and trays ......3-1

3.4.5 Emptying and replacing full sorting racks...........................................................3-1

3.4.6 Processing urgent samples .......................................................................................3-1

3.4.7 Processing recursive samples ..................................................................................3-1

3.4.8 Sample tracking (position, processing status)...................................................3-1

3.4.9 Archive samples ............................................................................................................3-1

3.5. Terminating routine operation after daily routine ...............................3-1

3.5.1 Perform data backups.................................................................................................3-1

3.5.2 Logout/System, shutdown and switching off.....................................................3-1

3.5.3 Checking the sorting area and the work area ...................................................3-1

3.5.4 Emptying the waste container..................................................................................3-1

3.5.5 Care and maintenance procedures........................................................................3-1

4. Maintenance ..........................................................................................4-1

4.1. Device care and maintenance ................................................................. 4-1

4.2. Cleaning agents and equipment .............................................................4-1

4.3. Care and maintenance schedule ............................................................ 4-1

4.3.1 Preventative maintenance..........................................................................................4-1

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VIII Operator's Manual - Version 1.6 - 10/2015

4.4. Weekly device care ....................................................................................4-1

4.4.1 Cleaning the decapper module ...............................................................................4-1

4.5. Monthly device maintenance...................................................................4-1

4.5.1 Cleaning system components ..................................................................................4-1

4.5.2 Cleaning the barcode reader....................................................................................4-1

4.5.3 Cleaning the sensors on the RT-Transport .........................................................4-1

4.5.4 Cleaning the infrared liquid level detection (IR-LLD).....................................4-1

4.5.5 Cleaning the laser liquid level detection (Laser-LLD) ....................................4-1

4.6. Device care, as and when required........................................................4-1

4.6.1 Cleaning the housing and component surfaces...............................................4-1

4.6.2 Cleaning the display.....................................................................................................4-1

4.6.3 Cleaning the sorting module grippers ..................................................................4-1

4.6.4 Cleaning the sensors on the feed-in and output modules ...........................4-1

4.6.5 Emptying the condensation container ..................................................................4-1

4.6.6 Cleaning the tube type identification module (BlueLynx camera).............4-1

4.6.7 Cleaning the quality module (QS I, QS I-LLD)...................................................4-1

4.6.8 Cleaning the recapper module ................................................................................4-1

4.7. Replacing parts ...........................................................................................4-1

4.7.1 Replacing the mains fuse...........................................................................................4-1

4.7.2 Replacing the lighting of tube type identification module............................4-1

5. Troubleshooting.....................................................................................5-1

5.1. What do I do if...? ........................................................................................5-1

5.1.1 ... the system is not working? ...................................................................................5-1

5.1.2 ... the control unit (computer) is not working? ..................................................5-1

5.1.3 ... the touch screen monitor is not working? ......................................................5-1

5.1.4 ... the communication in the network is not working?....................................5-1

5.1.5 ... the control unit (QNX PC) fails during operation?.......................................5-1

5.1.6 ... a power failure has occurred?.............................................................................5-1

5.1.7 ... no button is active on the touch screen monitor? .......................................5-1

5.1.8 ... daily data backup is causing problems?..........................................................5-1

5.1.9 ... the sorter unit does not put down the tubes properly? .............................5-1

5.1.10 ... problems occur when reading a barcode?.....................................................5-1

5.1.11 ... the recapping module is not working?.............................................................5-1

5.1.12 ... a tube is set down into an already-occupied position on the rack?.....5-1

5.1.13 ... the recapping module isn’t working? ...............................................................5-1

5.1.14 ... the decapper does not release the cap or is jammed?..............................5-1

5.1.15 ... the QS I camera fails to classify the sample? ................................................5-1

5.2. Important questions for customer service............................................ 5-1

5.2.1 General information .....................................................................................................5-1

5.2.2 Air pressure too low.....................................................................................................5-1

5.2.3 Problems with the motor control.............................................................................5-1

5.2.4 Problems with the tube transport at the in/ output sections .......................5-1

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Operator's Manual - Version 1.6 - 10/2015 IX

5.2.5 If there are problems with the input sorter/output sorter .............................5-1

5.3. System and error messages..................................................................... 5-1

5.3.1 (Error) messages which require intervention.....................................................5-1

5.3.2 Informative messages..................................................................................................5-1

6. Appendix .................................................................................................6-1

6.1. Included in delivery.................................................................................... 6-1

6.2. cobas p 512 system, technical data ....................................................... 6-1

6.2.1 Dimensions and weight..............................................................................................6-1

6.2.2 Current and voltage supply.......................................................................................6-1

6.2.3 Compressed air supply................................................................................................6-1

6.2.4 Operating conditions ...................................................................................................6-1

6.2.5 Ambient climatic conditions .....................................................................................6-1

6.2.6 Noise levels......................................................................................................................6-1

6.2.7 Heat emission .................................................................................................................6-1

6.2.8 Color of module .............................................................................................................6-1

6.3. Barcode scanner, technical data ............................................................ 6-1

6.3.1 Readable barcodes.......................................................................................................6-1

6.3.2 The definition of readable barcodes......................................................................6-1

6.3.3 Calculating the barcode check digit......................................................................6-1

6.3.4 Maximum number of digits.......................................................................................6-1

6.4. BlueLynx camera, technical data ............................................................6-1

6.5. QS I / QS I-LLD system (optional), technical data.............................. 6-1

6.6. Recapping module (optional), technical data......................................6-1

6.7. System interfaces ....................................................................................... 6-1

6.8. Device reliability .........................................................................................6-1

6.9. Accessories..................................................................................................6-1

6.10. Consumable materials............................................................................... 6-1

6.11. Sample tubes............................................................................................... 6-1

6.11.1 Dimensions of allowed tube types: ........................................................................6-1

6.12. Floorplan .......................................................................................................6-1

6.13. Glossary ........................................................................................................6-1

cobas p 512

XOperator's Manual - Version 1.6 - 10/2015

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