Roche cobas p 612 LCP1 User guide

cobas p 612

pre-analytical system (63x)

User Guide

Publication version 3.1

Software version 2.1.0

2

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Publication information

Revision history

Publication version Software version Revision date Change description

3.0 2.1.0 or higher April 2019 First version of the separated

safety guide and user guide

from the operators manual.

3.1 2.1.0 or higher December 2019 Updated Maintenance menu

screen shots, information

about analog and digital QSI

camera, barcode clarifications.

Modification of the decapping

module requires additional

cleaning procedures.

y Revision history

Edition notice

This publication is intended for operators of cobas p 612

pre-analytical system (63x).

Every effort has been made to ensure that all the

information contained in this manual is correct at the

time of printing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary

without notice as part of ongoing product development.

Where to find information

The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• Configuration information

• Background information such as measurement

principle

Privacy notice When you use User Assistance online,

viewing events (topics viewed and searches performed)

and IP addresses are logged. The data collected is for

Roche internal use only and is never forwarded to third

parties. It is anonymized, and after one year it is

automatically deleted. Viewing events are analyzed to

improve User Assistance content and search

functionality. IP addresses are used to classify regional

behavior.

The Safety Guide contains important safety information.

You must read the safety guide before operating the

system.

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Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

The User Guide consists of the chapters: system

description, operation, maintenance, troubleshooting,

glossary, and appendix. Embedded safety information is

incorporated in the User Guide. The chapters are

organized according to the normal operation workflow.

General attention

To avoid serious or fatal injury, ensure familiarization

with the system and safety information before use.

r Pay attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the system in a way that is not described

in this publication.

r Store all publications in a safe and retrievable place.

Training

Do not carry out operation tasks, maintenance actions, or

troubleshooting tasks without training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Screenshots

The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data, such as tests, results, or path names visible

therein must not be used for laboratory purposes.

4

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

wAn example of the type of screenshots used in this document

Warranty

Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Copyright

Open source and commercial software

Portions of the pre-analytical system include one or more

open source or commercial software programs.

Copyright, notices, and licensing information regarding

the software programs are available in the system.

Trademarks

The following trademarks are acknowledged: cobas and

cobas p are the trademark of Roche.

All other trademarks are the property of their respective

owners.

5

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Feedback

Every effort has been made to ensure that this

publication fulfils the intended purpose. All feedback on

any aspect of this publication is welcome and is

considered during updates. Contact the Roche Service

representative for any feedback.

Approvals

The cobas p 612 pre-analytical system meets the

protection requirements specified in IVD Directive 98/79/

EC.

The following marks demonstrate compliance:

For in vitro diagnostic use.

Complies with the provisions of the applicable EU

directives.

Issued by Intertek (Electrical Testing Laboratory) for

Canada and the US.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Germany

6

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

7Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Table of contents

Publication information 2

Intended use 10

About Good Laboratory Practice 10

Lists of symbols & abbreviations 11

What is new in publication version 3.1 14

System Description

1 Overview of the system

About the system 19

2 Hardware description

About control unit 25

About QNX operating system 26

About QSI computer 27

About interface panel 28

About input sorter module 29

About primary tube transport 30

About tube type identification camera 31

About Laser LLD 36

About spin status detection 39

About barcode reader 41

About decapping module 42

About tube separator 43

About barcode label printer 44

About print transport 45

About secondary tube transport 46

About aliquoting module 47

About the pipetting process 48

About recapping module 49

About output sorter module 50

About CCM integration 51

About status light 54

About compressed air connection 55

About accessories 56

About waste containers 57

Schematic representation of the hardware 58

3 Sample flow and processing

The system workflow 61

Schematic representation of sample

processing 62

About communication mode 63

About record transmission 64

About sorting list transmission 65

Barcode types 66

About sorting and error racks 67

About open sample tubes 68

About archiving sample tubes 69

About dynamic interface 70

About standard interface 71

4 Overview of the user interface

Software description 77

Serum TeachIn QSI 112

5 Overview of the User Assistance

About the User Assistance 125

Using User Assistance 126

Operation

6 Before routine operation

About commissioning the system 133

About the protective covers 134

Adjusting the position of monitor and

keyboard 135

Workflow before the operation 136

Prerequisites for scanning a barcode 137

Emptying waste containers 150

Reloading secondary tubes 152

About pipette tip racks 154

Inserting pipette tip racks 155

Emptying the condensate container 160

Inserting sealing foil for the recapping

module 161

Setting up the barcode label printer 165

Loading the input sorter module 174

Loading the output sorter module with

sorting racks 178

Loading the CCM with rack trays 179

Using the guide angle to load racks 180

Switching on the system 182

Login info 183

7 During routine operation

About workflow during operation 187

Selecting and starting the work cycle 188

Feeding primary samples 190

Loading input sorter with samples, racks,

and trays during operation 191

Emptying and replacing full sorting racks 193

Loading the 24-position centrifuge rack 195

Processing STAT samples 196

Processing recursive samples 197

Accessing sample data 199

Tracking sample status 200

Activating standby mode 201

Toggling between QSI and QNX 202

Error messages during the operation 203

8 After routine operation

Logging off from the system 207

Reorganizing for next use 208

Emptying output sorter 209

Shutting down the system 210

9 Non-routine operation

Emptying waste containers 213

8 Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Activating standby mode 215

Using main switch to power off 216

Adjusting the label edge sensor 217

Setting Date/Time 218

Rack feeds (CCM Hitachi®) 219

Rack feeds (CCM Sysmex®) 222

Archiving samples 225

Reorganizing database 226

Connecting the compressed air hose 227

Disconnecting the compressed air hose 228

Maintenance

10 Maintenace overview

About maintenance 233

Maintenance schedule 235

11 Weekly maintenance

Cleaning the pipetting unit 239

Cleaning the barcode label printer 243

Cleaning the print transport turning unit 247

Cleaning the decapping module 248

12 Monthly maintenance

About general monthly maintenance 257

Cleaning the barcode reader 258

Cleaning the primary tube transport sensors 260

Cleaning the Laser LLD 261

13 As needed maintenance

As needed maintenance 265

Replacing the main fuse 274

About the TTI module lighting 276

Emptying the condensate container 277

Troubleshooting

14 General troubleshooting

Resolving general problems 283

Troubleshooting on the barcode label printer

and reader 286

Barcode reading problems 288

Sorting area 289

Recapping, decapping, and camera modules 295

CCM connection 298

Laser-LLD, separator unit, and the aliquoting

module 301

15 System and error messages

General problems 311

List of error messages 312

List of informative messages 349

Appendix

16 System specifications

List of items included in delivery 361

List of electrical specifications 362

List of dimensions and weight specifications 363

List of compressed air supply specifications 364

List of environmental conditions

specifications 365

List of barcode reader specifications 366

Barcode reader 368

List of barcode label printer specifications 369

List of pipetting unit specifications 370

QSI system (optional) 372

List of recapping module specifications 374

List of system interface specifications 375

List of system operating time 376

List of cleaning solutions and equipments 377

17 Supported material

List of consumable materials 381

List of accessories 382

List of sample tubes specifications 383

List of caps specifications 385

List of racks specifications 386

Glossary

Index

9

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

10

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Intended use

cobas p 612 pre-analytical system (63x) is a computer-

controlled fully automatic system for sorting of open and

closed barcoded, centrifuged, and non-centrifuged

sample tubes. It is used with analyzers that perform tests

in the area of clinical chemistry, immuno chemistry,

coagulation, hematology, urinanalysis, and nucleic acid

testing.

It includes modules for registration and decapping of

sample tubes, liquid level detection, and sample quality

assessment (optional), recapping of sample tubes

(optional), barcode printing, as well as aliquoting of

primary and secondary tubes.

In case of standalone use of the pre-analytical system,

the transfer of tubes processed on the pre-analytical

system to any other workstation within the laboratory is a

subject of validation performed by laboratory itself.

About Good Laboratory Practice

Good Laboratory Practice

Some area of the instrument may have sharps, rough

edges, and/or moving parts.

r Good Laboratory Practice can reduce the risk of

injury. Be aware of your laboratory environment, be

well-prepared, and follow the Instructions for Use.

r Wear personal protective equipment to minimize the

risk of injury and contamination from bodily contact

with such parts, especially in less accessible areas, or

while cleaning the instrument.

r Your personal protective equipment should be

appropriate to the degree and type of potential

hazard such as suitable lab gloves, eye protection, lab

coat, and footwear.

11Lists of symbols & abbreviations

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Lists of symbols & abbreviations

This list is applicable to the entire user documentation.

Symbols used in the publication

Symbol Explanation

o

List item

u

Related topics containing further information

u

Topic

w

Figure

y

Table

q

Tip

I

Additional information

r

Task

d

Material

f

Procedure result

j

Pre-requisites

l

Checklist

c

Frequency

Caution

y Symbols used in the publication

Symbols used on product

Symbol Explanation

In vitro diagnostic device

Catalogue number

Serial number

Manufacturer

Date of manufacture

y Symbols used on product

12 Lists of symbols & abbreviations

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Symbol Explanation

Caution

Alternating current

Fuse

Disposal of control unit components

y Symbols used on product

Abbreviations used in the publication

Abbreviation Explanation

A Ampere

AC Alternating Current

ADP Air-displacement pipettor (pipetting module)

Ah Ampere hour

ASTM American Society for Testing and Materials

BGV Berufsgenossenschaftliche Vorschriften

CCM cobas connection module

CE Communauté Européenne

CPU Central processing unit

CU Control unit

dB Decibel

DC Direct current

DIN Deutsche Industrie Norm (German industry

standard)

DVD Digital versatile disc

ebox-one Control unit of the CCM

EC European community

EDP Event distribution protocol

EMC Electromagnetic compatibility

EN European standard

EPROM Erasable programmable read only memory

FCC Food chemicals codex

GB Gigabyte

GUI Graphical user interface

Hz Hertz

IEC International Electrotechnical Commission

IT Information technology

IQ/OQ Installation Qualification/Operation

Qualification

IVD In vitro diagnostic

LASER Light Amplification by Stimulated Emission of

Radiation

y Abbreviations used in the publication

13Lists of symbols & abbreviations

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Abbreviation Explanation

LCD Liquid crystal display

LED Light emitting diode

LIS Laboratory Information System

LLD Liquid level detection

MB Megabyte

Mbps Megabits per second

MTH Multi-tube holder

NN Normal null (mean sea level)

NW Nominal width

PCS Print Contrast Signal

PE Protective earth

PIO Parallel I-O interface

PRT Print transport

PTT Primary tube transport

QC Quality control

QSI Quality system one

RAM Random access memory

RCM Rack conveyor module

RFM Rack feed module

RJ45 Registered jack 45

ROI Region of Interest

RS232/422 Recommended standard 232/422

RSR Roche Service representative

SI Sample Image

STAT Short turn around time

STT Secondary tube transport

TCP/IP Transmission control protocol/ internet

protocol

TTI Tube type identification

UTC Universal Time Coordinated

UPS Uninterruptible power supply

V Volt

VA Volt-Ampere

WEEE Waste of Electrical and Electronic Equipment

cobas p 612 cobas p 612 pre-analytical system (63x)

y Abbreviations used in the publication

14 What is new in publication version 3.1

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

What is new in publication version 3.1

This section provides an overview of all major changes in

this publication and the software.

New topics

Following sections include new additions and updates

related to cobas p 612 (63x) pre-analytical system in the

User Guide.

u QSI quality system with camera and image

processing computer (32)

u Cleaning steps for modified decapping module (248)

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

System Description

1 Overview of the system...............................................................................17

2 Hardware description ..................................................................................23

3 Sample flow and processing.....................................................................59

4 Overview of the user interface .................................................................75

5 Overview of the User Assistance...........................................................123

17

Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Overview of the system

In this chapter

1

About the system ................................................................... 19

1 Overview of the system

18

Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

1 Overview of the system

19Overview of the system

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

About the system

cobas p 612 pre-analytical system (63x) is a computer-

controlled fully automatic system for sorting of open and

closed barcoded, centrifuged, and non-centrifuged

sample tubes. It is used with analyzers that perform tests

in the area of clinical chemistry, immuno chemistry,

coagulation, hematology, urinanalysis, and nucleic acid

testing.

• The system operates with an online connection to the

LIS.

Hardware overview

A

B

C

D

E F G

H

I

A Status light F Barcode label printer and applicator

B Control unit G Aliquoting module

C Tube type identification module H Output sorter

D Power switch I Recapping module

E Input sorter

wcobas p 612 pre-analytical system (63x)

System components

Component Function

Input sorter module Sample tubes are loaded onto this part of the instrument and

subsequently sorted.

y Main components of the cobas p 612 pre-analytical system (63x)

1 Overview of the system

20 About the system

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.1

Component Function

Aliquoting module A module that uses an air-displacement pipetter (ADP) with

pipette tips to aspirate and dispense sample material from

primary containers into secondary containers.

Output sorter module Sample tubes are sorted to designated targets and

subsequently unloaded from this module.

Control unit External PC that communicates with the instrument and

manages data.

Primary and secondary tube transport Units responsible for transporting primary and secondary

tubes.

Barcode readers Devices that read barcode labels on primary and secondary

tubes.

Barcode label printer and applicator Device that prints barcode labels and applies it on tubes.

Optical tube type identification Options: QSI full version, TTI camera

Decapping module Module where caps are removed from sample tubes.

Secondary tube separation and loading Unit separating a part of the sample from the primary samples.

Recapping module (optional) Module that closes sample container with sealing foils.

CCM module (optional) Module that enables an unidirectional connection of the pre-

analytical system to analysis instruments.

Connectivity to centrifuge units or BLM Device that is used for the automatic separation and

reorientation of closed sample containers.

y Main components of the cobas p 612 pre-analytical system (63x)

Intended user

cobas p 612 pre-analytical system (63x) is intended to

be used by trained laboratory technicians.

Training

• A Roche Service representative is present during the

system installation to train the operator.

• This training prepares the operator to perform routine

operation and maintenance actions safely without

close supervision.

Using the User Guide

• The document contains information useful for the

operator of the cobas p 612 pre-analytical system

(63x)

• It is not intended for the laboratory administrator or

Roche Service representatives.

• Failure to observe risk and safety notices present in

this user documentation can result in serious health

and safety implications and/or material damage.

• Read the User Guide with careful attention before

using the system for the first time.

• Pay particular attention to descriptions of hazards and

precautions.

• Keep the document accessible for all system

operators in the laboratory.

Customer configuration

• The system software is pre-configured with all

required processing parameters for daily operations

before the installation at the customer's location.

1 Overview of the system

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Roche cobas p 612 LCP1 User guide

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