Roche cobas p 512 LCP1 User guide

cobas p 512

pre-analytical system (64x)

User Guide

Publication version 3.0

Software version 2.1.0

2

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Publication information

Revision history

Publication version Software version Revision date Change description

3.0 2.1.0 2021 First version of the separated

safety guide and user guide

from the operators manual.

y Revision history

Edition notice This publication is intended for operators of cobas p 512

pre-analytical system (64x).

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.

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.

3

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

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 512 · Software version 2.1.0 · User Guide · Publication version 3.0

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.

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.

5

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Approvals The cobas p 512 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 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Page intentionally left blank.

7Table of contents

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

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 3.0 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 recapping module 43

About output sorter module 44

About CCM integration 45

About status light 48

About compressed air connection 49

About accessories 50

About waste container 51

Schematic representation of the hardware 52

3 Sample flow and processing

The system workflow 55

Schematic representation of sample

processing 56

About communication mode 58

About record transmission 59

About sorting list transmission 60

Barcode types 61

About sorting and error racks 62

About open sample tubes 63

About archiving sample tubes 64

About dynamic interface 65

About standard interface 66

4 Overview of the user interface

Software description 73

Serum TeachIn QSI 107

5 Overview of the User Assistance

About the User Assistance 121

Overview of User Assistance functions 123

Accessing the User Assistance online 125

Accessing the User Assistance offline 126

Operation

6 Before routine operation

About the protective covers 131

Adjusting the position of monitor and

keyboard 132

Workflow before the operation 133

Prerequisites for scanning a barcode 134

Emptying the waste container 147

Emptying the condensate container 148

Inserting sealing foil for the recapping

module 149

Loading the input sorter module 153

Loading the output sorter module with

sorting racks 157

Loading the CCM with rack trays 158

Using the guide angle to load racks 159

Switching on the system 161

Login info 162

7 During routine operation

About workflow during operation 167

Selecting and starting the work cycle 168

Feeding primary samples 170

Loading input sorter with samples, racks,

and trays during operation 171

Emptying and replacing full sorting racks 173

Loading a 24-position centrifuge rack 175

Loading collapsible rack trays 176

Processing STAT samples 178

Processing recursive samples 179

Accessing sample data 181

Tracking sample status 182

Activating standby mode 183

Toggling between QSI and QNX 184

Error messages during the operation 185

Toggling between QSI and QNX 187

8 After routine operation

Logging off from the system 191

Reorganizing for next use 192

Emptying output sorter 193

Shutting down the system 194

9 Non-routine operation

Emptying waste containers 197

Activating standby mode 198

Using main switch to power off 199

Setting Date/Time 200

Rack feeds (CCM Hitachi®) 201

Rack feeds (CCM Sysmex®) 204

Archiving samples 207

Reorganizing database 208

8Table of contents

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Connecting the compressed air hose 209

Disconnecting the compressed air hose 210

Maintenance

10 Maintenance overview

About maintenance 215

Maintenance schedule 217

11 Weekly maintenace

Cleaning the decapping module 221

12 Monthly maintenance

About general monthly maintenance 233

Cleaning the barcode reader 234

Cleaning the primary tube transport sensors 235

Cleaning the Laser LLD 236

13 As needed maintenance

As needed maintenance 239

Replacing the main fuse 246

About the TTI module lighting 248

Emptying the condensate container 249

Troubleshooting

14 General troubleshooting

Resolving general problems 255

Barcode reading problems 258

Sorting area 259

Recapping, decapping, and camera modules 264

CCM connection 267

15 System and error messages

General problems 273

List of error messages 274

List of informative messages 304

Appendix

16 System specifications

List of items included in delivery 313

List of electrical specifications 314

List of dimensions and weight specifications 315

List of compressed air supply specifications 316

List of environmental conditions

specifications 317

List of barcode reader specifications 318

Barcode reader 320

QSI system (optional) 321

List of recapping module specifications 323

List of system interface specifications 324

List of system operating time 325

List of cleaning solutions and equipments 326

17 Supported material

List of consumable materials 329

List of accessories 330

List of sample tubes specifications 331

List of cap specifications 333

List of rack specifications 334

Glossary

Index

9

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Intended use

cobas p 512 pre-analytical system (64x) 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), as well as recapping of sample

tubes (optional).

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 512 · Software version 2.1.0 · User Guide · Publication version 3.0

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 512 · Software version 2.1.0 · User Guide · Publication version 3.0

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

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

Hz Hertz

IEC International Electrotechnical Commission

IT Information technology

y Abbreviations used in the publication

12 Lists of symbols & abbreviations

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Abbreviation Explanation

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

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

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 512 cobas p 512 pre-analytical system (64x)

y Abbreviations used in the publication

13What is new in publication version 3.0

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

What is new in publication version 3.0

This section provides an overview of all major changes in

this publication and the software.

New Layout This publication version is created using the new

documentation layout.

New software version 2.1.0 The software description was adapted according to the

new software version 2.1.0. This new version includes

new features and new error messages.

Image udpate All photographs have been redone and post-processed.

New topics User Guide Following sections include new additions and updates

related to cobas p 512 (64x) pre-analytical system in the

User Guide.

uAbout interface panel (28)

uAbout the User Assistance (121)

uAbout tube type identification camera (31)

uAbout user rights (162)

uCleaning steps for modified decapping module (221)

uCleaning the housing and component surfaces (239)

uCleaning the rotary gripper (226)

uList of barcode reader specifications (318)

uList of rack specifications (334)

uLoading a 24-position centrifuge rack (175)

uLoading collapsible rack trays (176)

uOutput sorter - CCM (84)

uOutput sorter - CCM workplaces (85)

uOverview of User Assistance functions (123)

uPrimary tube dimension range (332)

uQSI quality system with camera and image

processing computer (32)

uSamples to be processed (332)

uSerum TeachIn QSI (107)

uSwitching on the system (161)

uUsing the guide angle to load racks (159)

14 What is new in publication version 3.0

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Page intentionally left blank.

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

System Description

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

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

3 Sample flow and processing.....................................................................53

4 Overview of the user interface .................................................................71

5 Overview of the User Assistance...........................................................119

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Page intentionally left blank.

17

Table of contents

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

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 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Page intentionally left blank.

1 Overview of the system

19Overview of the system

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

About the system

cobas p 512 pre-analytical system (64x) 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

AStatus light EInput sorter

BControl unit FRecapping module

CTube type identification module GOutput sorter

DPower switch

wcobas p 512 pre-analytical system (64x)

System components

Component Function

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

subsequently sorted.

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.

y Main components of the cobas p 512 pre-analytical system (64x)

1 Overview of the system

20 About the system

Roche Diagnostics

cobas p 512 · Software version 2.1.0 · User Guide · Publication version 3.0

Component Function

Primary tube transport Unit responsible for transporting primary tubes.

Barcode reader Device that reads barcode labels on primary tubes.

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

Decapping module Module where caps are removed from sample tubes.

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 512 pre-analytical system (64x)

Intended user cobas p 512 pre-analytical system (64x) 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 512 pre-analytical system

(64x)

• 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.

• The parameters for the software pre-configuration

include attention to:

• Tube types

• Sample types such as serum or coagulation

• Various positions in the sorting areas

• System modules are pre-programmed and optimized

as per the customer’s requirements.

1 Overview of the system

Page is loading ...

Roche cobas p 512 LCP1 User guide

Related papers

Other documents