Roche cobas p 671 User manual

cobas p 671 centrifuge unit

Operator's Manual

cobas p 671

II Operator's Manual - Version 1.4 - 10/2015

Manual version

Version

Creation date

0.7 (Draft Version)

September 2008

1.0

May 2009

1.1

March 2011

1.2

June 2011

1.2.5

September 2011

1.3

March 2012

1.3.1

April 2012

1.4

October 2015

Language

Order number

English

01019900161

German

01019900160

Edition notice

cobas p 671 centrifuge unit operator’s manual

This document is for users of the cobas p 671 centrifuge unit.

Every effort has been made to ensure that all the information contained in this manual is

correct at the time of printing. However, Roche PVT GmbH reserves the right to make any

changes necessary without notice as part of ongoing product development.

Any customer modification to the instrument will render the warranty or service agreement

null and void. For warranty conditions, refer to the analyzer purchase agreement. Contact

your local Roche Diagnostics representative for further information.

Software updates are done by Roche Diagnostics representatives.

Intended use

The cobas p 671 centrifuge unit is a computer controlled and fully-automatic unit for the

detection, registration and centrifugation of samples. It is equipped with components for

tube recognition, transportation and centrifugation. The cobas p 671 is utilized in

conjunction with pre-analytical systems, such as cobas p 512 and cobas p 612.

The cobas p 671 is intended as accessory for diagnostic use.

Before using the system, the operator must read the manual carefully.

Copyrights

Trademarks

cobas is a trademark of Roche.

All of the product names contained in this manual are trademarks of their respective owners.

cobas p 671

Operator's Manual - Version 1.4 - 10/2015 III

System approvals

The cobas p 671 centrifuge unit 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) and 89/336/EEC (EMC

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 regulations for laser equipment)

ETL labeling for North America

CB certificate

Compliance is demonstrated by the following marks:

corresponds

with the IVD directive 98/79/EC

and the EMC Directive 89/336/EEC

Contact addresses

Manufacturer

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

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.

Software compatibility

This issue of the Operator's Manual was written for the cobas p 671 centrifuge unit with

software version v1.3.2 o

r higher.

cobas p 671

IV Operator's Manual - Version 1.4 - 10/2015

cobas p 671

Operator's Manual - Version 1.4 - 10/2015 V

Table of contents

1. General Information ................................................................................... I

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

1.2. Using the operator's manual .................................................................... 1-1

1.3. Signs and symbols in the operator's manual ........................................ 1-1

1.4. Hazards and precautionary measures ................................................... 1-1

1.4.1 Safety instructions ........................................................................................................ 1-1

1.4.2 Notes on safety .............................................................................................................. 1-1

1.4.3 Electrical safety .............................................................................................................. 1-1

1.4.4 Samples ............................................................................................................................. 1-1

1.4.5 Barcode reader (optional) .......................................................................................... 1-1

1.4.6 Warning labels on the system .................................................................................. 1-1

1.5. Daily routine ................................................................................................. 1-1

1.6. Rack types for sample feeding ................................................................ 1-1

1.7. Centrifuge ..................................................................................................... 1-1

1.7.1 Emergency release of the centrifuge's lid ............................................................ 1-1

1.7.2 Rackset carriers ............................................................................................................. 1-1

1.8. Workstation .................................................................................................. 1-1

1.9. Disposal of device ...................................................................................... 1-1

1.10. Barcode reader (optional) ........................................................................ 1-1

1.10.1 Prerequisites for scanning a barcode ................................................................... 1-1

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

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

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

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

1.11. Abbreviations ............................................................................................... 1-1

2. System Description .................................................................................... I

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 Sample Flow and Processing .................................................................................... 2-1

2.1.5 Grade of Automation ................................................................................................... 2-1

2.1.6 System Reliability........................................................................................................... 2-1

2.2. Hardware Description ................................................................................ 2-1

2.2.1 System safety devices .................................................................................................. 2-1

2.2.2 Control Unit ..................................................................................................................... 2-1

2.2.3 Signal Lamp..................................................................................................................... 2-1

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

2.2.5 Input station .................................................................................................................... 2-1

2.2.6 Rack Transport ............................................................................................................... 2-1

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VI Operator's Manual - Version 1.4 - 10/2015

2.2.7 Gripper Unit ..................................................................................................................... 2-1

2.2.8 Storage Area ................................................................................................................... 2-1

2.2.9 Tube Type Identification ............................................................................................. 2-1

2.2.10 Barcode reader (optional) .......................................................................................... 2-1

2.2.11 Centrifuges ...................................................................................................................... 2-1

2.2.12 Inlet for compressed air supply ............................................................................... 2-1

2.2.13 Connectors and interfaces ........................................................................................ 2-1

2.2.14 Accessories...................................................................................................................... 2-1

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

2.3.1 Software structure ........................................................................................................ 2-1

2.3.2 QNX operating system ................................................................................................ 2-1

2.3.3 Graphical User Interface ............................................................................................ 2-1

2.3.4 Handling the menu system ........................................................................................ 2-1

2.3.5 Online Help ...................................................................................................................... 2-1

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

2.3.7 Error messages............................................................................................................... 2-1

2.4. Software Description ................................................................................. 2-1

2.4.1 Login und user rights .................................................................................................. 2-1

2.4.2 System selftest................................................................................................................ 2-1

2.4.3 Menu Structure on User Login ................................................................................ 2-1

2.4.4 Routine .............................................................................................................................. 2-1

2.4.5 Routine ► Main Screen ............................................................................................. 2-1

2.4.6 General buttons on subsequent screens ............................................................. 2-1

2.4.7 Routine ► Sorting Lists .............................................................................................. 2-1

2.4.8 Routine ► Information System ................................................................................ 2-1

2.4.9 Routine ► Clear Data ................................................................................................. 2-1

2.4.10 Maintenance ................................................................................................................... 2-1

2.4.11 Maintenance ► Se

rvice Cycles ............................................................................... 2-1

2.4.12 Maintenance ► Error History................................................................................... 2-1

2.4.13 Maintenance ► Date, Time, Day ............................................................................ 2-1

3. Operation ...................................................................................................... I

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

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

3.2.1 Notice on operating the protective cover ............................................................ 3-1

3.3. Preparations for routine operation ......................................................... 3-1

3.3.1 Overview ........................................................................................................................... 3-1

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

3.3.3 Turn on devices .............................................................................................................. 3-1

3.3.4 Login .................................................................................................................................. 3-1

3.3.5 System test ....................................................................................................................... 3-1

3.3.6 Submenu 'Routine' ► 'Main Screen' ..................................................................... 3-1

3.3.7 Database Reorganization ........................................................................................... 3-1

3.3.8 Preparing an empty output tray ............................................................................... 3-1

3.3.9 Preparing dummy racks .............................................................................................. 3-1

3.3.10 Providing a complete set of balance racks ......................................................... 3-1

3.3.11 Selecting the work cycle ............................................................................................ 3-1

3.3.12 Loading initial sample racks ..................................................................................... 3-1

cobas p 671

Operator's Manual - Version 1.4 - 10/2015 VII

3.4. Routine operation ....................................................................................... 3-1

3.4.1 Overview ........................................................................................................................... 3-1

3.4.2 Start sample processing ............................................................................................. 3-1

3.4.3 Interrupting operation ................................................................................................. 3-1

3.4.4 Respond to error messages ...................................................................................... 3-1

3.4.5 Reloading and unloading the rack trays .............................................................. 3-1

3.4.6 Centrifuge urgent samples ........................................................................................ 3-1

3.4.7 Centrifuge samples ahead of schedule ................................................................ 3-1

3.4.8 Ending sample processing ........................................................................................ 3-1

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

3.5.1 Overview ........................................................................................................................... 3-1

3.5.2 Logout / shutting down the system ....................................................................... 3-1

3.5.3 Inspecting the transfer area ...................................................................................... 3-1

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

4. Maintenance ............................................................................................... I

4.1. Introduction.................................................................................................. 4-1

4.2. Cleaning system components .................................................................. 4-1

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

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

4.4.1 Preventative maintenance .......................................................................................... 4-1

4.5. Centrifuge maintenance ............................................................................ 4-1

4.5.1 Pulling a centrifuge out of its cabinet ................................................................... 4-1

4.5.2 Cleaning the rotor chamber ...................................................................................... 4-1

4.5.3 Rubber care ..................................................................................................................... 4-1

4.5.4 Visual check for corrosion or damage .................................................................. 4-1

4.5.5 Visual check for cracks on the rackset carriers ................................................ 4-1

4.5.6 Lubricating the rackset carriers .............................................................................. 4-1

4.5.7 Inserting the rackset carriers .................................................................................... 4-1

4.5.8 Exchanging carrier and resetting revolutions counter.................................... 4-1

4.5.9 Returning the centrifuge into the cabinet ..

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

4.5.10 Emergency release of the centrifuge’s lid ........................................................... 4-1

4.6. System cleaning .......................................................................................... 4-1

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

4.6.2 Cleaning the tube type identification module .................................................... 4-1

4.6.3 Cleaning the optical sensors .................................................................................... 4-1

4.6.4 Cleaning the user interface ....................................................................................... 4-1

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

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

4.7.2 Replacing bulbs (tube type identification) .......................................................... 4-1

4.7.3 Replacing the rackset carriers ................................................................................. 4-1

5. Troubleshooting .......................................................................................... I

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

5.1.1 General information ..................................................................................................... 5-1

cobas p 671

VIII Operator's Manual - Version 1.4 - 10/2015

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

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

5.1.4 Problems with the tube transport at the input and output sections ......... 5-1

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

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

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

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

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

5.2.5 ... the control unit (computer) fails during operation? .................................... 5-1

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

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

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

5.2.9 ... a centrifuge's lid cannot be opened? ................................................................ 5-1

5.2.10 ... the output tray contains loaded racks? ............................................................ 5-1

5.2.11 ... error #063 occurs during loading of the centrifuge? ................................. 5-1

5.2.12 ... a rack is jammed at the output module (error #658)? ............................... 5-1

5.3. Opening the sorting gripper manually ................................................... 5-1

5.4. Messages ..................................................................................................... 5-1

5.4.1 Error messages and remedies .................................................................................. 5-1

5.4.2 Informative messages .................................................................................................. 5-1

6. Appendix ...................................................................................................... I

6.1. Scope of delivery ........................................................................................ 6-1

6.2. Technical Data ............................................................................................ 6-1

6.2.1 Power supply ................................................................................................................... 6-1

6.2.2 Compressed air supply................................................................................................ 6-1

6.2.3 Operating conditions ................................................................................................... 6-1

6.2.4 Ambient climatic conditions ..................................................................................... 6-1

6.2.5 Heat emission ................................................................................................................. 6-1

6.2.6 Device reliability ............................................................................................................. 6-1

6.2.7 Noise levels ..

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

6.2.8 Colors ................................................................................................................................. 6-1

6.2.9 Interfaces .......................................................................................................................... 6-1

6.2.10 Hettich Rotanta 460 Robotic centrifuge ............................................................... 6-1

6.2.11 Sample Tubes ................................................................................................................. 6-1

6.2.12 RD / Hitachi 5-slot racks (MPA) ............................................................................. 6-1

6.2.13 Barcode reader .............................................................................................................. 6-1

6.3. Floorplan ....................................................................................................... 6-1

6.4. Accessories .................................................................................................. 6-1

6.5. Glossary ........................................................................................................ 6-1

Part A

1. General Information

cobas p 671

II General Information v1.4 – 10/2015

cobas p 671

General Information v1.4 –10/2015 III

1. General Information ................................................................................... I

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

1.2. Using the operator's manual .................................................................... 1-1

1.3. Signs and symbols in the operator's manual ........................................ 1-2

1.4. Hazards and precautionary measures ................................................... 1-3

1.4.1 Safety instructions ........................................................................................................ 1-3

1.4.2 Notes on safety .............................................................................................................. 1-3

1.4.3 Electrical safety .............................................................................................................. 1-3

1.4.4 Samples ............................................................................................................................. 1-4

1.4.5 Barcode reader (optional) .......................................................................................... 1-4

1.4.6 Warning labels on the system .................................................................................. 1-5

1.5. Daily routine ............................................................................................... 1-11

1.6. Rack types for sample feeding .............................................................. 1-11

1.7. Centrifuge ................................................................................................... 1-11

1.7.1 Emergency release of the centrifuge's lid ......................................................... 1-11

1.7.2 Rackset carriers .......................................................................................................... 1-12

1.8. Workstation ................................................................................................ 1-13

1.9. Disposal of device .................................................................................... 1-13

1.10. Barcode reader (optional) ...................................................................... 1-13

1.10.1 Prerequisites for scanning a barcode ................................................................ 1-14

1.10.2 Barcode quality, printing and labeling material ............................................. 1-14

1.10.3 Specifications for the barcode labels ................................................................. 1-15

1.10.4 Placement of the barcode label ............................................................................ 1-17

1.10.5 Sample images of correct and incorrect barcode labels ............................ 1-18

1.11. Abbreviations ............................................................................................. 1-19

cobas p 671

IV General Information v1.4 – 10/2015

cobas p 671 Preface

General Information v1.4 – 10/2015 1-1

1.1. Preface

Read the operator's manual with the utmost care and attention before using the system for

the first time. Particular attention should be paid to descriptions of hazards and precautions.

Failure to observe notes pertaining to risks and safety contained in this operator's manual

can have serious implications for health and safety or result in material damage.

1.2. Using the operator's manual

This operator's manual contains information for operators of the system at the application

level. The information contained in this manual is not intended for administrators or service

technicians.

The operator's manual is divided into the following sections:

Part

Name

Contents

A

General Information

Editorial, description of the operator's manual, safety

information

B

System Description

System overview, description of the hardware,

description of the software

C

Operation

Working with the system

D

Maintenance

Maintenance and cleaning instructions

E

Troubleshooting

Describing and fixing errors

F

Appendix

Glossary, technical details, index

NOTICE

Ensure that the operator's manual is kept in close vicinity to the system and available to all users.

Additional information about the menu items is available in the online help of the system software.

Click the right stick button to invoke the online help.

Signs and symbols in the operator's manual cobas p 671

1-2 General Information v1.4 – 10/2015

1.3. Signs and symbols in the operator's manual

An explanation follows of the symbols used to clarify and interpret the information featured

in the operator's manual.

[Tab]

Key (keyboard)

[OK]

Button (screen)

'Menu 1' ▶ 'Menu 2'

Submenu in the control software including path

NOTICE

This indicates advice which the operator should observe in order to guarantee optimal operation of

the unit.

CAUTION

This symbol indicates a potential hazard. If this warning is not heeded, the device

can be damaged and/or the user may be at risk.

CAUTION

Pinching hazard: This symbol warns the operator not to reach inside areas where

there is a risk of injury from moving parts of the system.

WARNING

Laser light: This symbol warns of laser light that can be potentially hazardous to

the eyes.

WARNING

Risk of infection: This symbol warns of the risk from infectious samples.

WARNING

Mains voltage: This symbol warns the operator of areas where mains voltage is

active.

cobas p 671 Hazards and precautionary measures

General Information v1.4 – 10/2015 1-3

1.4. Hazards and precautionary measures

1.4.1 Safety instructions

CAUTION

To rule out the possibility of dangerous situations arising at the outset, you must

familiarize yourself with all precautionary measures and regulations concerning

the operation of the system as well as with its mechanical and electronic

equipment before starting the system.

The system must only be operated by personnel that have received specific

training for that purpose.

Pay particular attention to the safety instructions when handling samples.

1.4.2 Notes on safety

Safety regulations IEC 61010-1 and the applicable national electrical safety guidelines must

be observed!

Safe operation and reliability of the system can only be ensured if

• the electrical installation of the system meets appropriate IEC requirements.

• prescribed installation is performed by a trained expert.

• visual inspection, PE conductor test, insulation test and leakage current test are carried

out by a qualified electrician, if necessary (e.g. according to BGV A3 or other applicable

safety guidelines).

• the system is operated in accordance with the operating instructions.

1.4.3 Electrical safety

The system is delivered in a technically flawless condition and installed in full compliance

with local safety requirements.

WARNING

Electrical hazard!

Never open or remove the housing or parts of the housing of the system, the

computer or the monitor when the device is turned on!

Disconnect the mains voltage of the system before working inside the device (e.g.

cleaning the camera).

Hazards and precautionary measures cobas p 671

1-4 General Information v1.4 – 10/2015

1.4.4 Samples

Blood samples and other biologic/organic materials are to be treated as potentially infectious

and hazardous materials. Therefore, the operator must take the utmost care and attention

because it is possible that he or she will come into direct contact with patient samples!

WARNING

Risk of infection!

Always wear gloves when working on the system and comply with applicable

laboratory regulations.

Potential sample contamination!

If sample material is spilt onto the surface of the system, the affected surface must

be cleaned and disinfected.

If material from a tube spills during operation (from tipping or leakage on the working area

or in the centrifuge), the following measures must be taken:

1. Put the system into standby mode.

2. Manually remove all opened tubes from the module.

3. Clean the affected module and the surrounding surface areas. Spray the broad area with a

disinfectant. Be sure not to contaminate the contents of the open tubes.

1.4.5 Barcode reader (optional)

The camera module of the system can be optionally equipped with a barcode reader which

emits laser light. This poses a risk to the eye if the camera unit is opened with the laser

scanner enabled.

WARNING

Laser light can be potentially hazardous to the eyes.

To rule out any risk, always switch the system off at the main switch and

disconnect the mains cable prior to commencing maintenance work inside the

camera module!

cobas p 671 Hazards and precautionary measures

General Information v1.4 – 10/2015 1-5

1.4.6 Warning labels on the system

Warning labels are used to indicate potential safety hazards and point out any remaining

risk. All warning labels on the module and in areas that can be accessed by the operator are

documented below:

Figure 1-1: Warning labels on the system

A

Lower edge of the protective cover (general safety note)

B

Rack output (general safety note)

C

Rack output (pinching hazard)

D

Power supply behind the maintenance door

E

Power supply on the inner side of the maintenance door (see Figure 1-9)

F

Main power supply and fuse holder (see Figure 1-10)

G

Centrifuge mains switch (general safety note, see Figure 1-3)

H

Emergency release (general safety note, see part D 'Maintenance')

I

Centrifuge lid, beside the automatic loading hatch (pinching hazard, see Figure 1-2)

J

In front of protective cover lock, on both sides (system potentially infectious)

K

Rack input (pinching hazard)

L

Rack input (general safety note)

D

E

F

B

C

K

L

J

H

I

G

A

Hazards and precautionary measures cobas p 671

1-6 General Information v1.4 – 10/2015

This warning symbol on the centrifuge lid reminds you of the hazard of an automatically

opening and closing hatch in the centrifuge lid. There is a pinching hazard between the

housing of the centrifuge and the lid:

Figure 1-2: Lid of centrifuge

A

Centrifuge hatch

B

Warning label: pinching hazard

CAUTION

Pinching hazard!

Do not reach into the hatch of the centrifuge while it is opening or closing.

This warning label next to the bore hole for emergency release of the centrifuge lid warns you

of the risk posed by turning rotor. Before you open the centrifuge lid, make sure that the

rotor is at a standstill by looking through the window in the lid:

Figure 1-3: Centrifuge

A

Warning label: Emergency release

A

B

A

cobas p 671 Hazards and precautionary measures

General Information v1.4 – 10/2015 1-7

This warning label on front of the centrifuge warns you that switching the centrifuge off

during operation may lead to a system hazard.

Figure 1-4: Mains switch of the centrifuge

A

Key

C

Warning label

B

Mains switch

CAUTION

Never operate the mains switch or turn the key when the system is in operation!

This warning symbol on the front of the tube type identification module advises you of the

risk posed by the laser light (if a barcode reader is present):

WARNING

Risk of injury! Laser light can be potentially hazardous to the eyes. When

performing maintenance or adjustment procedures on the barcode reader, never

look directly into the laser beam/ aperture opening!

Figure 1-5: Tube recognition unit (rear side of device)

A

B

C

Hazards and precautionary measures cobas p 671

1-8 General Information v1.4 – 10/2015

These warning symbols on the rear of the tube type identification module advise you of the

hazards posed by mains voltage and laser light (if a barcode reader is present):

Figure 1-6: Tube type identification module (rear side of device)

A

Warning symbol: mains voltage

B

Warning symbol: laser light (optional)

WARNING

The housing of the tube recognition for camera lens cleaning should only be

opened when the device is turned off!

This warning symbol on the optional barcode reader inside of the tube type identification

module advise you of the risk posed by laser light:

Figure 1-7: Barcode reader (inside the tube type identification module; optional)

A

Warning label: laser light

A

B

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