Roche cobas p 612 User manual

cobas p 612 pre-analytical instrument

Operator’s Manual

Version 1.8

cobas p 612

II Operator's Manual – Version 1.8 – 10/2015

cobas p 612

Operator's Manual – Version 1.8 – 10/2015 III

1.1. Manual version

Version

Creation date

1.0

June 2007

1.1

January 2008

1.2

March 2008

1.3

September 2011

1.4 (draft)

September 2012

1.5

December 2012

1.6

December 2013

1.7

February 2014

1.8

October 2015

1.2. Intended use

The cobas p 612 pre-analytical system and cobas p 612 CCM variant pre-analytical system

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

centrifuged sample tubes, decapping and recapping of such, as well as aliquoting of primary

and secondary tubes.

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

sample quality detection as well as barcode printing.

In case of standalone use of the cobas p 612 pre-analytical system, the transfer of tubes,

processed on the cobas p 612 pre-analytical system, to any other workstation within the

laboratory is subject of validation performed by the laboratory itself.

1.3. Software compatibility

The Operator's Manual has been written for the cobas p 612 with software version V 1.6.0 or

higher.

cobas p 612

IV Operator's Manual – Version 1.8 – 10/2015

1.4. 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 contents of this manual is subject to change without any communicative obligations by

the company.

1.5. Norms and standards

The cobas p 612 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 (In-Vitro Diagnostics 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)

• DIN 12650 (pipetting unit)

The instrument complies with

IVD Directive 98/79/EC

1.6. 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.

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Operator's Manual – Version 1.8 – 10/2015 V

1.7. Contact address

Manufacturer

Roche Diagnostics GmbH

Roche Professional Diagnostics

Sandhofer

Strasse 116

D

-68305 Mannheim

Germany

cobas p 612

VI Operator's Manual – Version 1.8 – 10/2015

Table of contents

1.1. Manual version ............................................................................................... III

1.2. Intended use ................................................................................................... III

1.3. Software compatibility .................................................................................. III

1.4. Copyrights .......................................................................................................IV

1.5. Norms and standards ....................................................................................IV

1.6. Guarantee and warranty ..............................................................................IV

1.7. Contact address .............................................................................................. V

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

1.1. Preface .......................................................................................................... 1-5

1.2. Using the Operator’s Manual ................................................................... 1-6

1.3. Screen graphics, signs and symbols ...................................................... 1-7

1.4. Abbreviations ............................................................................................... 1-9

1.5. Hazards and precautionary measures ................................................. 1-11

1.5.1 Safety instructions ..................................................................................................... 1-11

1.5.2 Warning labels on the unit ..................................................................................... 1-11

1.5.3 Notes on safety ........................................................................................................... 1-23

1.5.4 Electrical safety ........................................................................................................... 1-23

1.5.5 Samples .......................................................................................................................... 1-23

1.5.6 Laser exposure ............................................................................................................ 1-24

1.6. Prerequisites for scanning a barcode .................................................. 1-25

1.6.1 Barcode quality, printing and labeling material ............................................. 1-25

1.6.2 Specifications for the barcode labels ................................................................. 1-26

1.6.3 Placement of the barcode label ............................................................................ 1-28

1.6.4 Sample images of correct and incorrect barcode labels ............................ 1-30

1.7. Disposal of device .................................................................................... 1-31

1.7.1 Information on Waste of Electrical and Electronic Equipment (WEEE) . 1-31

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

2.1. Introduction.................................................................................................. 2-5

2.1.1 Operator training ........................................................................................................... 2-5

2.1.2 Customer configuration .............................................................................................. 2-5

2.1.3 Specifications .................................................................................................................. 2-6

2.1.4 Level of automation ...................................................................................................... 2-7

2.1.5 Device reliability ............................................................................................................. 2-7

2.2. Hardware description ................................................................................ 2-8

2.2.1 Schematic diagram ....................................................................................................... 2-9

2.2.2 System safety devices .................................................................................................. 2-9

2.2.3 User interface .............................................................................................................. 2-10

2.2.4 QNX Computer ............................................................................................................ 2-11

2.2.5 QS I Computer ............................................................................................................. 2-12

2.2.6 Input sorter ................................................................................................................... 2-13

2.2.7 Tube transport (RT-Transport) .............................................................................. 2-14

2.2.8 Tube recognition ........................................................................................................ 2-14

2.2.9 Infrared liquid level detection (IR-LLD) ............................................................. 2-20

2.2.10 Laser liquide level detection (Laser-LLD) ........................................................ 2-22

2.2.11 Decapper module ....................................................................................................... 2-25

2.2.12 Secondary tube separation..................................................................................... 2-26

2.2.13 Barcode printer ........................................................................................................... 2-27

2.2.14 Print transport (PT-Transport) ............................................................................... 2-29

2.2.15 Secondary tube transfer unit ................................................................................. 2-29

2.2.16 Secondary tube transport (TT-Transport) ......................................................... 2-29

2.2.17 Barcode scanner for secondary tubes ............................................................... 2-30

2.2.18 Pipetting module ........................................................................................................ 2-31

2.2.19 Recapper module (optional) .................................................................................. 2-33

2.2.20 Output sorter ................................................................................................................ 2-35

2.2.21 Signal lamp .

.................................................................................................................. 2-36

2.2.22 Operating modes ........................................................................................................ 2-36

2.3. Consumable material ............................................................................... 2-37

2.3.1 Fluid system .................................................................................................................. 2-37

2.3.2 Container for consumables .................................................................................... 2-39

2.3.3 Waste container .......................................................................................................... 2-41

2.3.4 Compressed air connection ................................................................................... 2-42

2.4. Mains connection and system interfaces ........................................... 2-45

2.5. Accessories ................................................................................................ 2-46

2.5.1 Carriers, racks and rack trays ................................................................................ 2-46

2.5.2 Compressor .................................................................................................................. 2-46

2.5.3 Cleaning brush ............................................................................................................ 2-47

2.5.4 Cleaning sets ............................................................................................................... 2-47

2.5.5 Cleaning set for barcode printer .......................................................................... 2-48

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Operator's Manual – Version 1.8 – 10/2015 IX

2.6. Sample flow and sample processing ................................................... 2-49

2.6.1 A sample's route through the cobas p 612 system ....................................... 2-49

2.6.2 Processing profiles and priorities ......................................................................... 2-50

2.6.3 Defining sorting racks .............................................................................................. 2-51

2.6.4 Processing open sample tubes ............................................................................. 2-51

2.6.5 Processing samples with insufficient fluid quantities .................................. 2-51

2.6.6 Processing recursive sample tubes ..................................................................... 2-52

2.6.7 Processing multiple patient samples with the identical barcode ............ 2-53

2.6.8 Archiving the sample tubes ................................................................................... 2-55

2.7. Basic information about the software .................................................. 2-56

2.7.1 Structure of the software ........................................................................................ 2-56

2.7.2 QNX operating system ............................................................................................. 2-56

2.7.3 Communication with the laboratory host computer ..................................... 2-56

2.7.4 Graphic user interface .............................................................................................. 2-58

2.7.5 How to use the menu system ................................................................................ 2-59

2.7.6 Online help ................................................................................................................... 2-60

2.7.7 System status and messages ................................................................................. 2-61

2.7.8 Error messages............................................................................................................ 2-61

2.8. Software description ................................................................................ 2-63

2.8.1 Login and user rights ................................................................................................ 2-63

2.8.2 System test .................................................................................................................... 2-64

2.8.3 Log out / shut down system .................................................................................. 2-64

2.8.4 Structure of the menus ............................................................................................ 2-65

2.8.5 Main menu Routine ................................................................................................... 2-66

2.8.6 Routine menu – Control........................................................................................... 2-66

2.8.7 Routine menu – Sorting Lists ................................................................................ 2-76

2.8.8 Routine menu – Information system ................................................................... 2-79

2.8.9 Routine menu – Clear data ..................................................................................... 2-95

2.8.10 Routine menu – S

tatistics ....................................................................................... 2-96

2.8.11 Maintenance menu ................................................................................................... 2-99

2.8.12 Maintenance menu – Prime system ................................................................. 2-100

2.8.13 Maintenance menu – Error History ................................................................... 2-103

2.8.14 Maintenance menu – Daily Backup .................................................................. 2-105

2.8.15 Maintenance menu – Date, Time, Day............................................................. 2-106

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X Operator's Manual – Version 1.8 – 10/2015

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

3.1. Commissioning the system ...................................................................... 3-5

3.2. Daily routine ................................................................................................. 3-5

3.2.1 Trouble-free operating procedures ........................................................................ 3-5

3.3. Preparation ................................................................................................. 3-13

3.3.1 Emptying the waste container ............................................................................... 3-14

3.3.2 Reloading secondary tubes .................................................................................... 3-14

3.3.3 Inserting Disposable Tips Trays ............................................................................ 3-17

3.3.4 Emptying the condensate container ................................................................... 3-22

3.3.5 Inserting sealing foil for the recapping module ............................................. 3-23

3.3.6 Media of the barcode printer ................................................................................ 3-26

3.3.7 Loading the output sorter with sorting racks .................................................. 3-35

3.3.8 Loading the input sorter with tubes, racks and rack trays ........................ 3-36

3.3.9 Switching on the system ......................................................................................... 3-39

3.3.10 Login ............................................................................................................................... 3-40

3.3.11 System test .................................................................................................................... 3-40

3.3.12 Selecting the work cycle ......................................................................................... 3-41

3.4. Operation .................................................................................................... 3-42

3.4.1 Starting sample processing .................................................................................... 3-44

3.4.2 Visual check of the syringe and pipetting function during rinsing ......... 3-44

3.4.3 Interrupt sample processing .................................................................................. 3-45

3.4.4 Toggling between QS I-LLD and QNX (if QS I-LLD present) ................... 3-46

3.4.5 React to error messages .......................................................................................... 3-46

3.4.6 Loading input sorter with samples, racks and trays during operation .. 3-48

3.4.7 Emptying and replacing full sorting racks ........................................................ 3-49

3.4.8 Processing urgent samples .................................................................................... 3-50

3.4.9 Processing recursive samples ............................................................................... 3-51

3.4.10 Sample tracking (position, processing status) ................................................ 3-52

3.4.11 Archive samples ......................................................................................................... 3-54

3.5. Terminating routine operation after daily routine ............................. 3-55

3.5.1 Perform data backups .............................................................................................. 3-56

3.5.2 Performing a reorganization .................................................................................. 3-56

3.5.3 Cleaning the liquid system ..................................................................................... 3-56

3.5.4 Logout / shutting down system and switching off ........................................ 3-57

3.5.5 Checking the sorting area and the work area ................................................ 3-57

3.5.6 Emptying the waste container ............................................................................... 3-57

3.5.7 Care and maintenance procedures ..................................................................... 3-58

3.6. Barcode printer ......................................................................................... 3-59

3.6.1 General safety instructions for installation and operation ......................... 3-59

3.6.2 Barcode printer A4 + ................................................................................................ 3-60

3.6.3 Setup barcode printer A4 + ................................................................................... 3-63

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

4.1. Device care and maintenance ................................................................. 4-5

4.2. Cleaning agents and equipment ............................................................. 4-6

4.3. Care and maintenance schedule ............................................................ 4-7

4.3.1 Maintenance ................................................................................................................... 4-7

4.4. Weekly device care .................................................................................... 4-8

4.4.1 Cleaning the pipetting pin ......................................................................................... 4-8

4.4.2 Cleaning the liquid system ........................................................................................ 4-9

4.4.3 Cleaning the barcode printer A4 + series ........................................................ 4-10

4.4.4 Cleaning the decapper module ............................................................................ 4-12

4.4.5 Cleaning the waste tube of the pipetting unit ................................................ 4-17

4.5. Monthly device maintenance................................................................. 4-20

4.5.1 Cleaning system components ............................................................................... 4-20

4.5.2 Cleaning the barcode scanner .............................................................................. 4-21

4.5.3 Cleaning the sensors on the RT-Transport ...................................................... 4-22

4.5.4 Cleaning the infrared liquid level detection (IR-LLD) .................................. 4-23

4.5.5 Cleaning the laser liquid level detection (Laser-LLD) ................................. 4-24

4.6. Device care, as and when required ...................................................... 4-25

4.6.1 Cleaning the housing and component surfaces ............................................ 4-25

4.6.2 Cleaning the display .................................................................................................. 4-25

4.6.3 Cleaning the disposable tip carrier ..................................................................... 4-25

4.6.4 Cleaning the sorting module grippers ............................................................... 4-25

4.6.5 Cleaning the sensors on the input and output sorter .................................. 4-26

4.6.6 Emptying the condensation container ............................................................... 4-27

4.6.7 Cleaning the quality module (QS I, QS I-LLD) ................................................ 4-28

4.6.8 Cleaning the cap recognition unit ....................................................................... 4-29

4.6.9 Cleaning the recapping module ........................................................................... 4-30

4.7. Replacing parts ......................................................................................... 4-31

4.7.1 Replacing the mains fuse ........................................................................................ 4-31

4.7.2 Replacing the lighting (tube type identification module) ........................... 4-33

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

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

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

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

5.1.3 ... the printer is not working? .................................................................................... 5-5

5.1.4 ... the touch screen monitor is not working? ...................................................... 5-5

5.1.5 ... the communication in the network is not working? .................................... 5-5

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

5.1.7 ... a power failure has occurred? ............................................................................. 5-6

5.1.8 ... no button is active on the touch screen monitor? ....................................... 5-6

5.1.9 ... daily data backup is causing problems?.......................................................... 5-6

5.1.10 ... the sorter unit does not put down the tubes properly? ............................. 5-6

5.1.11 ... problems occur when reading a barcode? ..................................................... 5-6

5.1.12 ... the recapping module is not working? ............................................................. 5-7

5.1.13 ... a tube is set down into an already-occupied position on the rack? ..... 5-8

5.1.14 ... the system indicates that there are no more secondary tubes available

although the container is not empty? ................................................................... 5-9

5.1.15 ... a disposable tip is lost? .......................................................................................... 5-9

5.1.16 ... a disposable tip is lying in the pipetting area? ........................................... 5-10

5.1.17 ... the disposable tips do not fall although the waste tube anymore? ... 5-10

5.1.18 ... secondary tube is sorted to the default rack? ............................................ 5-10

5.1.19 ... the dilutor syringe is leaking? ........................................................................... 5-11

5.1.20 ... the hose system is leaking? ............................................................................... 5-12

5.1.21 ... level errors are displayed? .................................................................................. 5-12

5.1.22 ... foam is pipetted? ................................................................................................... 5-12

5.1.23 ... incorrect fluid amounts are dispensed?........................................................ 5-12

5.1.24 ... the recapping module isn’t working? ............................................................ 5-12

5.1.25 … the pipetting tip descends into the separation gel (primary tube)? . 5-13

5.1.26 ... the decapper does not release the cap or is jammed? ........................... 5-15

5.1.27 ... the QS I camera fails to classify the sample? ............................................. 5-16

5.2. Important questions for customer service .......................................... 5-18

5.2.1 General information .................................................................................................. 5-18

5.2.2 Air pressure too low .................................................................................................. 5-18

5.2.3 Problems with the motor control .......................................................................... 5-18

5.2.4 Problems with the tube transport at the in/ output sections .................... 5-18

5.2.5 If there are problems with the input sorter/output sorter .......................... 5-18

5.3. System and error messages ................................................................... 5-19

5.3.1 (Error) messages which require intervention .................................................. 5-20

5.3.2 Informative messages ............................................................................................... 5-59

5.3.3 Error display Printer A4 + series .......................................................................... 5-64

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

6.1. Included in delivery .................................................................................... 6-5

6.2. Technical data ............................................................................................. 6-6

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

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

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

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

6.2.5 Ambient climatic conditions ..................................................................................... 6-7

6.2.6 Noise levels ...................................................................................................................... 6-7

6.2.7 Heat emission ................................................................................................................. 6-7

6.2.8 Color of module ............................................................................................................. 6-7

6.3. Barcode scanner, technical data ............................................................ 6-7

6.3.1 Readable barcodes ....................................................................................................... 6-8

6.3.2 Definition of readable barcodes .............................................................................. 6-8

6.3.3 Calculating the bar code check digit .................................................................... 6-8

6.3.4 Maximum number of digits ....................................................................................... 6-8

6.4. Barcode printer A4 +, technical data ..................................................... 6-8

6.5. Pipetting unit, technical data ................................................................... 6-9

6.5.1 System liquid ................................................................................................................... 6-9

6.5.2 Dosage volumes ............................................................................................................ 6-9

6.5.3 Accuracy and tolerance ........................................................................................... 6-10

6.6. QS I system (optional), technical data ................................................ 6-11

6.7. Recapper module (optional), technical data ...................................... 6-12

6.8. System interfaces ..................................................................................... 6-12

6.9. System operating time............................................................................. 6-13

6.10. Consumable materials ............................................................................. 6-13

6.11. Accessories ................................................................................................ 6-14

6.12. Sample tubes ............................................................................................. 6-14

6.12.1 Dimensions of allowed tube types....................................................................... 6-14

6.13. Floorplan ..................................................................................................... 6-15

6.14. Glossary ...................................................................................................... 6-18

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XIV Operator's Manual – Version 1.8 – 10/2015

cobas p 612 Part A – General information

Operator's Manual – Version 1.8 – 10/2015 1-1

Part A

1. General information

Part A – General information cobas p 612

1-2 Operator's Manual – Version 1.8 – 10/2015

cobas p 612 Part A – General information

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