Roche cobas p 612 LCP1 User guide

cobas p 612

pre-analytical system (63x)

User Guide

Publication version 3.2

Software version 2.1.0

2

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

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.

3.2 2.1.0 or higher March 2021 Safety Guide

Update of: Data security, labeling on protective covers

New information about: Name plate for systems with serial

number starting 632xxxxx

User Guide

Update of: cleaning agents for protective covers, cleaning

procedures for modified decapping module, tube specifications,

switching on the system

New information about: 24 position rack for 16 mm tubes, new

barcode label printer, samples to be processed, loading collapsible

rack trays

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

The Safety Guide contains important safety information.

It includes grouped safety messages and topics such as

Safety information for laser exposure. You must read the

safety guide before operating the system.

3

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

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.

rPay attention to all safety precautions.

rAlways follow the instructions in this publication.

rDo not use the system in a way that is not described

in this publication.

rStore all publications in a safe and retrievable place.

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

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 3.2

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.

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 3.2

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 3.2

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7Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

Table of contents

Publication information 2

Intended use 9

About Good Laboratory Practice 9

Lists of symbols & abbreviations 10

What is new in publication version 3.2 13

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 Series A4+ barcode label printer 44

About SQUIX barcode label printer 45

About print transport 46

About secondary tube transport 47

About aliquoting module 48

About the pipetting process 49

About recapping module 50

About output sorter module 51

About CCM integration 52

About status light 55

About compressed air connection 56

About accessories 57

About waste containers 58

Schematic representation of the hardware 59

3 Sample flow and processing

The system workflow 63

Schematic representation of sample

processing 64

About communication mode 65

About record transmission 66

About sorting list transmission 67

Barcode types 68

About sorting and error racks 69

About open sample tubes 70

About archiving sample tubes 71

About dynamic interface 72

About standard interface 73

4 Overview of the user interface

Software description 79

Serum TeachIn QSI 116

5 Overview of the User Assistance

About the User Assistance 129

Overview of User Assistance functions 131

Accessing the User Assistance online 133

Accessing the User Assistance offline 134

Operation

6 Before routine operation

About the protective covers 139

Adjusting the position of monitor and

keyboard 140

Workflow before the operation 141

Prerequisites for scanning a barcode 142

Emptying waste containers 155

Reloading secondary tubes 157

About pipette tip racks 159

Inserting pipette tip racks 160

Emptying the condensate container 165

Inserting sealing foil for the recapping

module 166

Setting up the barcode label printers 170

Loading the input sorter module 195

Loading the output sorter module with

sorting racks 199

Loading the CCM with rack trays 200

Using the guide angle to load racks 201

Switching on the system 203

Login info 204

7 During routine operation

About workflow during operation 209

Selecting and starting the work cycle 210

Feeding primary samples 212

Loading input sorter with samples, racks,

and trays during operation 213

Emptying and replacing full sorting racks 215

Loading a 24-position centrifuge rack 217

Loading collapsible rack trays 218

Processing STAT samples 220

Processing recursive samples 221

Accessing sample data 223

Tracking sample status 224

Synchronizing the SQUIX paper feed 225

Starting the SQUIX peel-off mode 226

Activating standby mode 227

Toggling between QSI and QNX 228

Error messages during the operation 229

8 After routine operation

Logging off from the system 233

Reorganizing for next use 234

8Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

Emptying output sorter 235

Shutting down the system 236

9 Non-routine operation

Emptying waste containers 239

Activating standby mode 241

Using main switch to power off 242

Adjusting the label edge sensor 243

Setting Date/Time 244

Rack feeds (CCM Hitachi®) 245

Rack feeds (CCM Sysmex®) 248

Archiving samples 251

Reorganizing database 252

Connecting the compressed air hose 253

Disconnecting the compressed air hose 254

Maintenance

10 Maintenance overview

About maintenance 259

Maintenance schedule 261

11 Weekly maintenance

Cleaning the pipetting unit 265

Cleaning the barcode label printers 269

Cleaning the print transport turning unit 278

Cleaning the decapping module 279

12 Monthly maintenance

About general monthly maintenance 291

Cleaning the barcode reader 292

Cleaning the primary tube transport sensors 294

Cleaning the Laser LLD 295

13 As needed maintenance

As needed maintenance 299

Replacing the main fuse 308

About the TTI module lighting 310

Emptying the condensate container 311

Troubleshooting

14 General troubleshooting

Resolving general problems 317

Troubleshooting the barcode label printers

and readers 320

Barcode reading problems 323

Sorting area 324

Recapping, decapping, and camera modules 330

CCM connection 333

Laser-LLD, separator unit, and the aliquoting

module 336

15 System and error messages

General problems 345

List of error messages 346

List of informative messages 383

Appendix

16 System specifications

List of items included in delivery 397

List of electrical specifications 398

List of dimensions and weight specifications 399

List of compressed air supply specifications 400

List of environmental conditions

specifications 401

List of barcode reader specifications 402

Barcode reader 404

List of SQUIX 4.3 barcode label printer

specifications 405

List of pipetting unit specifications 406

QSI system (optional) 407

List of recapping module specifications 409

List of system interface specifications 410

List of system operating time 411

List of cleaning solutions and equipments 412

17 Supported material

List of consumable materials 415

List of accessories 416

List of sample tube specifications 417

List of cap specifications 419

List of rack specifications 420

Glossary

Index

9

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

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.

rGood Laboratory Practice can reduce the risk of

injury. Be aware of your laboratory environment, be

well-prepared, and follow the Instructions for Use.

rWear 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.

rYour 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.

10 Lists of symbols & abbreviations

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

Lists of symbols & abbreviations

This list is applicable to the entire user documentation.

Symbols used in the publication Symbol Explanation

oList item

uRelated topics containing further information

uTopic

wFigure

yTable

qTip

IAdditional information

rTask

dMaterial

fProcedure result

jPrerequisites

lChecklist

cFrequency

Caution

y Symbols used in the publication

Symbols used on product Symbol Explanation

In vitro diagnostic device

Catalog number

Serial number

Intertek Electrical Testing Laboratory

Manufacturer

y Symbols used on product

11Lists of symbols & abbreviations

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

Symbol Explanation

Date of manufacture

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 modules

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

ETL Electrical Testing Laboratories

FCC Food chemicals codex

GB Gigabyte

GS1 Global Standard 1

GTIN Global Trade Item Number (trade item

identifier to look up product information in a

database)

GUI Graphical user interface

y Abbreviations used in the publication

12 Lists of symbols & abbreviations

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

Abbreviation Explanation

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

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

13What is new in publication version 3.2

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

What is new in publication version 3.2

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.

uSwitching on the system (203)

uLoading collapsible rack trays (218)

uCleaning steps for modified decapping module (279)

uLoading a 24-position centrifuge rack (217)

uCleaning the housing and component surfaces (299)

uPrimary tube dimension range (418)

uAbout SQUIX barcode label printer (45)

uCleaning the rotary gripper (284)

uList of rack specifications (420)

uSamples to be processed (418)

14 What is new in publication version 3.2

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

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Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

System Description

1 Overview of the system...............................................................................17

2 Hardware description ..................................................................................23

3 Sample flow and processing.....................................................................61

4 Overview of the user interface .................................................................77

5 Overview of the User Assistance...........................................................127

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

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17

Table of contents

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

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 3.2

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1 Overview of the system

19Overview of the system

Roche Diagnostics

cobas p 612 · Software version 2.1.0 · User Guide · Publication version 3.2

About the system

System definition 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

AStatus light FBarcode label printer and applicator

BControl unit GAliquoting module

CTube type identification module HOutput sorter

DPower switch IRecapping module

EInput 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 3.2

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 containers with sealing foil.

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

Roche cobas p 612 LCP1 User guide

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