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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.
Copyright © 2001-2014, Roche Diagnostics GmbH. All rights reserved.
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
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
IPB ACUDSP AQN BCLRSP/RSF FSS (AQS) OPB
B
A
/