Roche MODULAR Pre Analytics User manual

MODULAR PRE-ANALYTICS

EVO

Operator’s Manual

MODULAR PRE-ANALYTICS EVO

Roche Diagnostics

2Operator’s Manual · Version 9.1

Document information

Revision history Manual

Version

Software

Version

Revision date Changes

1.0 TSM

1.0 MPA

02-04 May 2001 All MPA modules

2.0 (Draft) 02-10 October 2002 CLAS 2 modules included; modified

TSM functionality, modified MPA

modules

3.0 (Draft) 03-01 MPA PLUS modifications

4.0 03-01 2003 MPA PLUS and CLAS 2

components summarized in one

Operator’s Manual

5.0 03-01 August 2003 Single Source technically refined

and contents restructured

6.0 04-02 November 2004 FSS information added

6.1 04-02 February 2005 Risk comments for FSS added to the

Operator’s Manual

7.0 04-02 April 2005 PSS information added to the

Operator’s Manual. General updates

7.1 04-02 September 2006 Changes for compliance with UL

2nd edition. New BCL printing

mechanism

8.0 06-04 September 2007 Redundant Data Review modules

removed, New tray types added,

Line Monitor updated to System

Monitor, Direct? help implemented

8.1 06-04 November 2007 Safety information updated

8.2 06-04/06-05 March 2008 Added ITF barcodes without a

check digit description, Reference

Condition dialog box, Change

Stocker Tray and Priority check box.

8.3 06-13 July 2011 Incorporated addenda (RSF and

DSP lift-up type). Describe new

identification of ACU bucket sets

9.0 06-16 and

above

07-01 and

above

June 2014 Added information on new CLAS 2

units, SBU-MA(B), and PET; and an

additional Caution

9.1 06-16 and

above

07-01 and

above

July 2014 Added new tab and minor updates

to Utility window

Roche Diagnostics

Operator’s Manual · Version 9.1 3

MODULAR PRE-ANALYTICS EVO

Edition notice MODULAR PRE-ANALYTICS EVO (MPA) Operator’s Manual. "EVO" signifies the

color of the equipment.

Audience This Operator’s Manual is for users of MODULAR PRE-ANALYTICS EVO with

CLAS 2 or PLUS configurations.

Content change policy 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.

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

agreement null and void.

Software updates Software updates are performed by Roche service representatives.

Software compatibility The instructions described in this Operator’s Manual refer to the following system

configuration:

oTotal System Manager Software Version 06-16 or higher

oMODULAR PRE-ANALYTICS EVO module software: 07-01/51-01 or higher

The connected MODULAR PRE-ANALYTICS EVO controller software version

requests a referred software release version for the following:

oMODULAR ANALYTICS EVO: 06-04 or higher

oMODULAR ANALYTICS EVO E combinations: 01-04 or higher

oMODULAR ANALYTICS EVO SWA: 07-01 or higher

ocobas® 6000: 01-02 or higher

Intended use The MODULAR PRE-ANALYTICS EVO system is a fully automated system for

sample pre-processing, including centrifuging, aliquoting, and barcode labeling,

prior to analysis by MODULAR SYSTEMS EVO analyzers.

It is important that the operator reads this manual thoroughly before using the

system.

Trademarks COBAS, COBAS C, COBAS E, ELECSYS, LIFE NEEDS ANSWERS, and MODULAR

are trademarks of Roche.

All other trademarks are the property of their respective owners.

Language Order Number

English 3517357-018

French 3517357-080

German 3517357-001

Italian 3517357-050

Portuguese 3517357-046

Spanish 3517357-036

MODULAR PRE-ANALYTICS EVO

Roche Diagnostics

4Operator’s Manual · Version 9.1

Instrument approvals Our instruments meet the protection requirements laid down in IVD Directive 98/

79/EC and the European Standard EN 591. Furthermore, our instruments are

manufactured and tested according to the international safety standard EN 61010-1,

2nd edition from 2001. Compliance is demonstrated by the following marks:

The analyzer complies with the emission and immunity requirements described in

the following standard:

IEC 61326-2-6:2005 (Electrical equipment for measurement, control and laboratory

use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic

(IVD) medical equipment)

Contact addresses

Manufacturer

Authorized representative

Complies with the IVD Directive 98/79/EC.

CUS

®

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.

Hitachi High-Technologies Corporation

24-14. Nishi-shimbashi. 1-chome. Minato-ku

Tokyo. 105-8717 JAPAN

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim

Germany

Roche Diagnostics

Operator’s Manual · Version 9.1 5

MODULAR PRE-ANALYTICS EVO

Table of contents

Document information 2

Contact addresses 4

Preface 7

Description Part A

1 Safety information

Safety classifications A-5

Safety information A-5

Safety precautions A-23

2 System and module overview

Introduction A-35

System configurations A-37

Control Unit A-39

Total System Manager (TSM) A-39

Rack and sample flow A-40

Rack and sample identification A-42

Alarms A-43

General specifications A-44

3 Control Unit and TSM

Introduction A-49

Control Unit hardware A-49

Total System Manager (TSM) A-50

TSM software components A-59

4Core modules

Input Buffer Module (IPB) A-85

Output Buffer Module (OPB) A-91

Output Buffer Module (OPB) with priority port A-93

Core Transport Line (CTL) A-96

Core Transport Line (CTL) with Return Line A-97

5 Sample-processing modules

Automatic Centrifuge (ACU) A-101

Destopper (DSP) A-107

Destopper (DSP), lift-up type A-109

Online Aliquoter (AQN) A-111

Barcode Labeler (BCL) A-119

Restopper Module (RSP) and Flexible Restopper

Module (RSF) A-129

Primary Sample Sorter (PSS) and Flexible Sample

Sorter (FSS) A-131

Aliquot Sorter (AQS) A-141

6 Connection Line components

Turntable Line (TUL) A-151

Sample Buffer and Connection Unit for

MODULAR ANALYTICS EVO (SBU-MA) A-153

Sample Buffer Unit for cobas® 6000 (SBU-C6) A-155

7CLAS 2 components

Universal Connection Line (UCL) A-159

Sample Buffer Unit (SBU) A-165

Turntable Unit (TUS) A-167

Transport Line (TL) A-169

CLAS 2 Connection Line (CL2) A-170

Connection Line (CL) A-171

cobas®8000 B-Gate Sample Buffer Unit

(SBU-MA(B)) A-172

Pitch Exchange Turntable Unit (PET) A-174

Operation Part B

8 Daily operation

Daily workflow B-5

Operating precautions B-5

Prepare for system start up B-6

MPA system start up B-7

Prepare the MPA modules for operation B-10

Monitoring and controlling MPA B-25

Loading samples B-33

Processing samples B-37

Exchanging trays B-42

Handling problematic samples B-44

Shut down the system B-51

9 Special operation: How to...

Users: How to B-57

Find samples, aliquots, and racks B-59

Online Help: How to B-60

Alarms: How to B-62

System Monitor: How to B-66

CLAS Line Monitor: How to B-66

Sample Monitor: How to B-67

Data Review: How to B-69

Test Selection: How to B-72

Rack Registration: How to B-75

Utility: How to B-79

Configuration: How to B-84

10 Reports

Introduction B-93

Printing reports B-93

Report details B-95

Non-supported Reports B-102

11 Configuration

Configuration window B-105

Using aliquot groups B-113

Roche Diagnostics

6Operator’s Manual · Version 9.1

MODULAR PRE-ANALYTICS EVO

Maintenance Part C

12 Maintenance procedures

Introduction C-5

Daily maintenance C-7

Weekly maintenance C-11

As-needed maintenance C-14

Monthly maintenance C-29

Maintenance log C-30

Troubleshooting Part D

13 Basic troubleshooting

Viewing alarms D-5

Alarm levels and recovery D-7

Recovering from a power failure D-8

14 Limited operation

Introduction D-11

Core modules (IPB, OPB) not functioning D-11

Automatic Centrifuge (ACU) reset D-11

Automatic Centrifuge (ACU) not functioning D-12

Destopper (DSP) error D-13

Destopper not functioning D-13

Online Aliquoter (AQN) aliquot error D-14

Online Aliquoter (AQN) not functioning D-15

Barcode Labeler (BCL) not functioning D-16

Restopper Module (RSP) or Flexible Restopper

(RSF) not functioning D-17

Primary Sample Sorter (PSS) or Flexible Sample

Sorter (FSS) or Aliquot Sorter (AQS)

not functioning D-17

Connection Line components not functioning D-18

CLAS 2 components not functioning D-18

Total System Manager (TSM) not functioning D-20

Handling errors with TSM D-21

Glossary Part E

Glossary E-3

Index Part F

Index F-3

Notes Part G

MODULAR PRE-ANALYTICS EVO G-3

Maintenance log G-3

Roche Diagnostics

Operator’s Manual · Version 9.1 7

MODULAR PRE-ANALYTICS EVO

Preface

The MODULAR PRE-ANALYTICS EVO (MPA) system is an automated, software-

controlled system for processing patient samples before they go for analysis. The

MPA system centrifuges and aliquots patient samples, as required, and automatically

takes care of the removal and insertion of container stoppers, and barcode labeling.

Samples from the MPA system can be fed directly into other Roche Diagnostics

MODULAR SYSTEMS EVO, without the intervention of laboratory staff. In this way,

a completely automated sample flow, starting from primary containers through to

analysis and disposal, can be realized.

The operating software, known as Total System Manager (TSM), tracks the samples

through the system and communicates with the Laboratory Information System

(LIS) to determine how each sample is to be processed.

By processing samples automatically, the complexity of the everyday routine is

simplified and the sample flow in the laboratory is made much more efficient. This

frees up human resources and improves safety due to the reduction of direct contact

with sample material.

Scope and audience

This Operator’s Manual is intended for operators of the MODULAR

PRE-ANALYTICS EVO (MPA) system with CLAS 2 or PLUS configurations and

describes procedures available to operators with access rights up to supervisor level.

Information specific to service procedures is not contained in this publication.

The MPA system may be connected to other, 3rd party equipment. Please refer to the

equipment manufacturer’s documentation for further information.

MODULAR PRE-ANALYTICS EVO

Roche Diagnostics

8Operator’s Manual · Version 9.1

How to use this manual

To help you find information quickly, there is a table of contents at the beginning of

the book and each chapter. In addition, a complete index can be found at the end.

This manual contains detailed descriptions of MPA features and its operation

including the software. Information is divided into the following parts:

oPart A - System Description provides an overview of the MPA system, its

constituent modules, and the operating software (TSM). It also contains

specifications and a detailed description of the theory of operation for each

module.

oPart B - Operation describes the daily workflow and basic Operational tasks.

oPart C - Maintenance describes the maintenance schedules and procedures.

oPart D - Troubleshooting describes potential problems and how to solve them.

oPart E - Glossary provides definitions of the terms used in this manual.

oPart F - Index provides a basic index to help you to find the information you

need.

oPart G - Notes provides blank pages for readers’ notes and a blank maintenance

log sheet for monthly record keeping.

Where to find information

In addition to the Operator's Manual, the Online Help system provided with the

MODULAR PRE-ANALYTICS EVO system enables you to find information about

the system quickly. The Online Help is available on the Control Unit (main system

PC) running the Total System Manager (TSM) software.

For information about other MODULAR SYSTEMS EVO instruments, for example,

MODULAR ANALYTICS EVO SWA, refer to the operator’s manual for that specific

instrument.

TSM Online Help system

MODULAR PRE-ANALYTICS EVO (MPA) has a context-sensitive Online Help

feature to aid in operating MPA. “Context-sensitive” means that wherever you are

located within the MPA software, choosing the Help feature displays Help text or a

screenshot relating to that area of the software. The Online Help offers a quick and

convenient way to find information, such as explanations of screens and dialog boxes

and how to perform particular processes. MPA offers two sources of online

information, F1 Help and Direct? Help.

F1 Help There are two main entry points for the Online Help: a context-sensitive entry via the

Help buttons in the software or F1 on the keyboard, or the main entry via the Help

icon in the bottom left of the screen. The context sensitive entry displays text or a

screenshot relating to your current location in the software.

oKeep the Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use.

oUse the instrument as specified in the Operator’s Manual, otherwise the protection

provided by the instrument might be reduced.

oThe Operator’s Manual should be easily accessible at all times.

Roche Diagnostics

Operator’s Manual · Version 9.1 9

MODULAR PRE-ANALYTICS EVO

Direct? Help Direct? Help provides help related to a specific element in the window or dialog box.

Direct? Help is useful for viewing brief, tip-style descriptions or definitions for

specific elements. Click the Direct? button (?) in the title bar to change the mouse

pointer to a question mark, and then click any element in the window or dialog box.

e

For more information, see Online Help: How to on page B-60.

Customer information

Customer training Contact your local Roche Service representative for any questions or information

regarding MODULAR PRE-ANALYTICS EVO system training.

Contact Customer Service Contact your local Roche Service representative for further information regarding

the MODULAR PRE-ANALYTICS EVO system service agreement.

Ordering information Replacement parts and consumable materials should be ordered from Roche

Diagnostics. When ordering, please use the Roche Diagnostics catalog number and

reference name for each item.

Conventions used

Visual cues are available to help you to quickly locate and interpret information. This

section explains formatting conventions used.

Symbols

The following symbols are used:

Symbol Used for

aStart of procedure

oList item

e

Cross-reference

hCall-up (software reference)

Tip

Safety alert

Laser radiation

Biohazard

Showing differences between CLAS 2 and PLUS configurations

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

MPA

+

C2SAL

MODULAR PRE-ANALYTICS EVO

Roche Diagnostics

10 Operator’s Manual · Version 9.1

Abbreviations

The following abbreviations are used:

Abbreviation Definition

A

ACU Automatic Centrifuge

AQN Online Aliquoter

AQS Aliquot Sorter

B

BCL Barcode Labeler

C

CL Connection Line

CL2 Connection Line from MPA PLUS to the UCL of CLAS 2

CLAS 2 Clinical Laboratory Automation System 2nd generation

CTL Core Transport Line

D

DI Data Innovation

DSP Destopper

E

ECL Electrochemiluminescence

EMC Electromagnetic compatibility

F

FSS Flexible Sample Sorter

I

IEC International Electrical Commission

IPB Input Buffer Module

K

KVA Kilovolt-Ampere. Unit for expressing rating of AC electrical machinery.

L

LDL Lower detection limit

LIS Laboratory Information System

LLD Liquid level detection

M

MPA MODULAR PRE-ANALYTICS EVO

MSDS Material safety data sheet

N

n/a Not applicable

NCCLS National Committee for Clinical Laboratory Standards

O

OLH Online Help

OPB Output Buffer

P

PET Pitch Exchange Turntable Unit (not available in the USA)

PSM Process Systems Manager (formerly Preanalytic Systems Manager)

PSS Primary Sample Sorter

R

RSF Flexible Restopper

RSP Restopper

Roche Diagnostics

Operator’s Manual · Version 9.1 11

MODULAR PRE-ANALYTICS EVO

S

SBU Sample Buffer Unit

SBU-C6 Sample Buffer and Connection Unit for cobas® 6000

SBU-MA Sample Buffer and Connection Unit for MODULAR ANALYTICS EVO

SBU-MA(B) cobas®8000 B-Gate Sample Buffer Unit (not available in the USA)

T

TL Transport Line

TSM Total System Manager

TUL Turntable Line

TUS Turntable Unit

U

UCL Universal Connection Line

UL Underwriters Laboratories Inc.

Abbreviation Definition

MODULAR PRE-ANALYTICS EVO

Roche Diagnostics

12 Operator’s Manual · Version 9.1

1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 System and module overview . . . . . . . . . . . . . . . . . . . . . . . . . . A-33

3 Control Unit and TSM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-47

4 Core modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-83

5 Sample-processing modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-99

6 Connection Line components . . . . . . . . . . . . . . . . . . . . . . . . . . A-149

7 CLAS 2 components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-157

Description A

Roche Diagnostics

Operator’s Manual · Version 9.1 A-3

MODULAR PRE-ANALYTICS EVO 1 Safety information

Table of contents

Safety information

Before operating the MPA it is essential that the user reads and understands the

warnings, cautions, and safety requirements listed in the Operator’s Manual (also in

this Online Help). This chapter describes the safety classifications and shows the

physical locations of safety information on the MPA. It also lists the safety texts

found throughout the rest of the manual.

Safety classifications .........................................................................................................A-5

Safety information ............................................................................................................ A-5

Instructional notices ..................................................................................................A-6

Positions of safety labels on pre-analytic processing modules ............................ A-8

Positions of safety labels on connection line components ................................. A-11

Positions of safety labels on additional connection components .....................A-14

Safety precautions ..........................................................................................................A-23

Electrical shock warnings .......................................................................................A-25

Biohazardous materials ...........................................................................................A-26

Mechanical parts warnings .....................................................................................A-27

Warnings ...................................................................................................................A-28

Cautions ....................................................................................................................A-29

Electromagnetic compatibility ...............................................................................A-31

Peripheral device connections ...............................................................................A-31

Interleaved 2 of 5 barcodes without a check digit ...............................................A-32

In this chapter Chapter 1

Roche Diagnostics

A-4 Operator’s Manual · Version 9.1

1 Safety information MODULAR PRE-ANALYTICS EVO

Table of contents

Roche Diagnostics

Operator’s Manual · Version 9.1 A-5

MODULAR PRE-ANALYTICS EVO 1 Safety information

Safety classifications

Before operating the MODULAR PRE-ANALYTICS EVO it is essential that the user

reads and understands the warnings, cautions, and safety requirements listed here.

This section explains how precautionary information is formatted.

e

For information on safety precautions, see Safety precautions on page A-23.

The safety precautions and important user notes are classified according to

ANSI Z535 standards. Familiarize yourself with the following meanings and icons:

Safety information

Warning labels have been placed on MODULAR PRE-ANALYTICS EVO to draw

your attention to areas of potential hazards. The labels and their definitions are as

follows:

WARNING

Warning

Indicates a potentially hazardous situation which, if not avoided, could result in death or

serious injury.

Always follow the instructions highlighted by this symbol.

CAUTION

Caution

Indicates a potentially hazardous situation which, if not avoided, could result in minor or

moderate injuries, or damage to equipment.

If the labels are damaged, they must be replaced. For replacement labels, contact your

local Roche representative.

Electric Shock Warning

This label indicates there is a danger of electric shock from

electrical components when gaining access to parts of the system

marked with this label.

Warning

This label indicates there is a danger of hazardous situations

within the vicinity of this label, which may result in death or

serious injury.

This label also indicates that documentation must be consulted in

all cases where the symbol is displayed.

Biohazard Warning

This label indicates there are potential biohazards within the

vicinity of this label. The relevant laboratory procedures on safe

use must be observed.

Mechanical Parts Warning

This label indicates there is a danger of coming into contact with

moving mechanical parts within the vicinity of this label.

Roche Diagnostics

A-6 Operator’s Manual · Version 9.1

1 Safety information MODULAR PRE-ANALYTICS EVO

Safety information

Instructional notices

These labels provide instructional information about the devices to which they are

attached. Follow the instructions provided on the labels to prevent damage to the

instrument or yourself.

Input Buffer (IPB)

Destopper (DSP)

Barcode Labeler (BCL)

Caught Up Warning

This label indicates there is a risk of being caught up in moving

parts which may result in slight or minor injuries.

Do Not Disassemble

This label indicates the instrument must not be disassembled by

unqualified persons because slight or minor injuries, or damage

to equipment may occur.

Do Not Touch

This label indicates the area within the vicinity of this label

should not be touched because slight or minor injuries, or

damage to equipment may occur.

Figure A-1 STAT rack input label (IPB)

Note

Ensure correct orientation

Of the rack when loading

the rack in the STAT position.

Figure A-2 Stopper waste duct label (DSP)

TOP

BOTTOM

Do not set the

duct upside down

Figure A-3 ROLL LOADING INSTRUCTIONS label (BCL)

ROLL LOADING

INSTRUCTIONS

Push the FEED key of the printer several times

in order to adjust the label position after

exchanging a roll / ribbon.

Caution :

Push the RESTART key when error occurred.

Roche Diagnostics

Operator’s Manual · Version 9.1 A-7

MODULAR PRE-ANALYTICS EVO 1 Safety information

Safety information

Figure A-4 NOTICE on Opening the door label (BCL)

Figure A-5 Caution label warning against mixing buckets from different bucket sets

Figure A-6 Bucket-set number label from an ACU bucket

NOTICE on Opening the door

Operate BCL as following when opening the door for replacing

a label or a ribbon.

1. Input C.STOP key onAQN Module then confirm it has been stopped.

2. Confirm there are no sample racks inside the BCL.

3. Push C.STOP key on BCLthen confirm it has been stopped.

4. Open the door for replacing a label or a ribbon.

This door has been hardware interlocked. The door can be opened

during C.STOP or STOP status of BCL. But, anytime after open

the door, restart would be initiated from the reset process.

It is recommended to make sure that there are no racks to be

reset before opening the door.

Loss of sample and damage to ACU

Follow the instruction below.

If not follow, could result in loss of samples or

serious damage to ACU.

1. Set 4 buckets with same bucket-set-number

on the same ACU.

2. Perform the maintenance and part replacement

for the instrument performance retention.

S3095402

CAUTION

S309548

Bucket-set-number Color

101

Date

28.Apr.2010

Roche Diagnostics

A-8 Operator’s Manual · Version 9.1

1 Safety information MODULAR PRE-ANALYTICS EVO

Safety information

Positions of safety labels on pre-analytic processing modules

The following figures show the safety labels as supplied with the system (subject to

change without notification). You will see the internal labels only when you open the

covers or doors to gain access to the inside of the modules.

.

The following diagrams show MODULAR PRE-ANALYTICS EVO systems that include

either a Restopper (RSP) or a Flexible Restopper (RSF) and either a Flexible Sample Sorter

(FSS) or an Aliquot Sorter (AQS), as used on earlier systems. A Primary Sample Sorter

(PSS) may also be included on a MODULAR PRE-ANALYTICS EVO system, upstream of

the ACU.

The PSS, FSS and AQS modules are physically identical and have the same warning and

caution labels. The RSP and RSF are physically identical and have the same warning and

caution labels.

AExternal safety labels BInternal safety labels

Figure A-7 MPA top view - safety labels. (Note: Lines between labels are for identification purposes only.)

IPB ACUDSP AQN BCLRSP/RSF FSS (AQS) OPB

B

A

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Roche MODULAR Pre Analytics User manual

Roche MODULAR Pre Analytics User manual

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