Roche cobas 8000 Data Manager User manual

cobas

®

8000 data manager

Operator's Manual

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 3

cobas® 8000 data manager

Document information

Revision history

Edition notice

This Operator's Manual is for users of the cobas

®

8000 data manager, which is part of

the cobas

®

8000 modular analyzer series. The cobas

®

8000 data manager consists of a

PC which coordinates data in real time between the cobas

®

8000 instrument and the

host (usually the laboratory information system (LIS)).

Every effort has been made to ensure that all the information is correct at the time of

publishing. However, Roche Diagnostics International Ltd. reserves the right to make

any changes necessary without notice as part of ongoing product development.

Any customer modification to the cobas

®

8000 data manager will render the warranty

or service agreement null and void.

Intended use

The cobas

®

8000 data manager provides data and workflow management for the in

vitro diagnostic medical device cobas

®

8000 modular analyzer series.

License information

The cobas

®

8000 data manager is protected by contract law, copyright laws, and

international treaties. The cobas

®

8000 data manager is licensed for use between F.

Hoffmann-La Roche Ltd and a licensee, and only users authorized there under are

permitted to access and use the software. Un-authorized use and distribution may

result in civil and criminal penalties.

Open Source and Commercial

Software

cobas

®

8000 data manager might contain components or modules that are Open

Source or Commercial Software programs. For copyright and other notices and

licensing information regarding such software programs included with cobas

®

8000

data manager please see the CD/ DVD provided with the product.

The product and the cobas

®

8000 data manager as a whole may form a regulated

device in accordance with the applicable laws - please refer to the installation DVD of

the cobas

®

8000 data manager software for details. Please note that the respective

authorization in accordance with the applicable laws lapse in case of any

unauthorized changes to the cobas

®

8000 data manager.

Manual

version

Software

version

Revision

date

Main changes

1.03

(Revision 1)

1.03 Jul-2012 Creation of standalone version of data manager

operator’s manual.

Integration of software update installer chapter.

Integration of online help content into print

version.

Integration of review comments from the Roche

Service and Training department.

New glossary for standalone manual.

Update of TraceDoc chapter.

Added description of sequence mode.

Added workflows in chapter pass-through mode

and software update installer.

Table 1 Revision history

cobas® 8000 data manager

Roche Diagnostics

4 Operator's Manual · Version 1.03, Revision 1

Trademarks

cobas

®

8000 data manager is a trademark and the cobas® 8000 data manager logo is a

trade-mark of Roche. Other product names and trademarks are the property of their

respective owners.

The following trademarks are acknowledged:

COBAS, COBAS C, and LIFE NEEDS ANSWERS trademarks of Roche.

All other trademarks are the property of their respective owners.

Approvals

The cobas

®

8000 modular analyzer series meets the protection requirements specified

in IVD Directive 98/79/EC. Furthermore, the cobas® 8000 data manager is

manufactured and tested according to the following international safety standards:

Compliance is demonstrated by the following labels:

Contact addresses

Complies with the IVD directive 98/79/EC.

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

CUS

®

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 5

cobas® 8000 data manager

Table of contents

Document information 3

Contact addresses 4

Table of contents 5

Preface 9

Safety classification 11

Safety precautions 12

Safety summary 13

Disposal of the equipment 15

Operation data manager

1 Introduction

Introduction to the cobas

®

8000 data manager 21

The cobas

®

8000 data manager and associated

workflows 22

Starting the cobas

®

8000 data manager 24

The cobas

®

8000 data manager interface 29

Default workplaces 31

Standard tasks 32

2 Pass-through mode

Introduction 39

Using the pass-through modes 40

Pass-through mode activation 41

Pass-through mode for patient results 42

Pass-through mode for QC results and

calibration results 45

Pass-through mode data flow scenarios 46

3 Routine tasks

Working with samples 51

Working with tests 60

Validating test results manually 67

Results reporting 70

Masking and unmasking tests 71

System information 74

4QC

QC Parameters 79

QC Routine 91

5 Routine configuration

Overview 99

Configuring sample types 100

Setting up test groups 101

Configuring profiles 103

Masking profiles 105

Configuring SOPs 107

Managing processing intervals 110

6 Test configuration

Working with tests and reference ranges 115

Calculated tests 129

Managing formulas 133

Configuring test measurement units 138

Managing comment texts 140

7 System configuration

Editing the organization’s contact details 145

Data cleanup (data manager) 146

Initiating an archive run manually 149

Configuring autoprint for reports 150

Changing date and time 151

Synchronizing data manager with TSN agent 152

Instruments 153

Using log files 156

8 Administration

Managing workplaces 159

Managing users 161

9 Data clean-up and archiving

Introduction 167

Data retrieval and storage 168

Data clean-up 169

Uploading data to Roche 170

Data archiving 171

Data purging 174

Browsing data using the TraceDocViewer 175

TraceDocViewer reference 179

10 Software update installer

The software update installation (SUI)

process 191

Update procedures 198

Troubleshooting and recovery 207

Roche Diagnostics

6 Operator's Manual · Version 1.03, Revision 1

cobas® 8000 data manager

Software description

11 Routine windows

Host backup 215

Search patient 217

Sample overview 218

Sample comment 223

Sample history 224

Sample tracking 225

Previous results 226

Test comment 227

Test history 228

Test details 229

Request dilution for test: <x> 231

Day list 232

Search criteria 237

Validation 238

Test mask overview 242

Result entry 244

System status 245

System alarms 246

System status 247

System alarm 248

12 QC routine windows

QC Routine 251

Insert comment 255

Result details 256

QC standby bottles 258

13 QC Parameter windows

Control material 261

Insert control material 266

Copy control 268

Control history 269

Westgard rules 270

Insert Westgard rule / Edit Westgard rule 273

Westgard rules assignment 276

History 277

QC data alarm 278

QC configuration 279

Calibration method rules 280

Insert calibration method rule 281

Calibration recommendations 282

14 Routine configuration windows

Sample type 285

Edit sample type 286

Test groups 287

Insert/edit test group 288

Profiles 289

Profile 290

Assign tests 291

Profile in profile 292

Masking profiles 293

Masking profile 294

SOP overview 295

Create popup / Popup details and assignment 296

Processing intervals 297

Processing intervals 298

15 Test configuration windows

Tests / reference ranges 301

Test / reference ranges 302

Reference range for <x> 308

Insert Action 310

Text input 311

Detection limits 312

Component for test units 313

Formula definition 314

Parameters 317

Formulas 318

Formulas 319

Logs 321

History 322

Settings 323

Comment texts 324

Comment text groups 325

Comment texts 326

Comment group 327

Comment group assignment 328

Test units 329

Conversion factor 330

16 System configuration windows

Organization 333

Organization 334

System configuration 335

Instrument 340

Tasks 343

Configuration 344

Edit configuration 345

Communication messages 346

XML information 348

Log files 349

Log information 350

Log information per application 351

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cobas® 8000 data manager

17 Administration windows

Workplaces 355

Workplaces 356

Global properties 357

Assignment component - workplace 358

User 359

User ID 360

User/Workplaces 361

Assignment user - workplace 362

User / Icons 363

Assignment user - icons 364

User system rights overview 365

Copy authorizations 366

18 Service windows

Password profile 371

Password profile 372

Instrument groups 373

Edit instrument group 374

Assignment instrument group - instrument 375

Data alarms 376

Edit data alarm 377

Icons 378

Icon 379

Sex 380

Sex 381

Priorities 382

Priority 383

Sample status 384

Sample status 385

Test status 386

Test status 387

Validation status 388

Validation status 389

Service-related configuration 391

System messages overview 397

System message parameters 400

Edit parameter 401

Active level 402

Special configuration 403

System information configuration detail 405

Real time alarms configuration 406

Glossary

19 Glossary

Index

Index 413

Roche Diagnostics

8 Operator's Manual · Version 1.03, Revision 1

cobas® 8000 data manager

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 9

cobas® 8000 data manager

Preface

The cobas

®

8000 data manager implements data and workflow management

functions and provides an interface between the cobas® 8000 modular analyzer, the

host, and the Roche TeleService-Net (TSN). Through TSN it enables remote access to

and from Roche and allows information exchange. It provides enhanced sample

tracking, test management, result traceability, storage and reporting, together with

quality control and calibration management. Additionally, it has host backup

functionality and serves as a robust storage location for the instrument.

This manual provides detailed descriptions of the data manager features and

operational concepts, specific functions and administration procedures.

How to use this manual

o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use.

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

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.

Where to find information

For information on the individual components of the cobas 8000 instrument series

see:

o cobas® 8000 modular analyzer series Operator’s Manual

o cobas® 8000 modular analyzer series Online Help

o cobas® 8000 data manager Operator’s Manual

o cobas® 8000 data manager Online Help

Online Help

The cobas® 8000 data manager has a context sensitive online help feature to support

you in its operation. Context sensitive means that the help system always displays

information related to the current window or software element. Therefore, the help

system offers a quick and convenient way to find information.

The instrument software offers two help features:

o F1 Help

o Direct Help

F1 Help - This help feature displays information related to the current window. Use

the F1 Help feature if you require detailed information about this window. Hypertext

links guide you to additional information and procedures related to this window.

The Operator's Manual is included in the F1 Help system. This allows you to search for

information throughout the software reference and the manual. All cross-references are

implemented as hyperlinks.

cobas® 8000 data manager

Roche Diagnostics

10 Operator's Manual · Version 1.03, Revision 1

Symbols and abbreviations

Visual cues are used to help locate and interpret information in this document

quickly. This section explains formatting conventions used in this document.

Symbols The following symbols are used:

Abbreviations The following abbreviations are used:

Symbol Comment

o List item

Start of procedure

End of procedure

Cross-reference

f Navigation path indication

Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

Table 2 Symbols used for easy recognition of information

Abbreviation Definition

A

ANSI American National Standards Institute

AU1, AU2, … Analytical Unit 1, 2, … (used in the user interface only)

C

c module photometric module (c 701 / c 702 / c 502)

c7-1, c7-2, c7-3 First, second, third c 701 / c 702 module of the instrument

Cal., CAL Calibration

Cfas Calibrator For Automated Systems

ClinChem Clinical chemistry

CV Coefficient of Variation (%)

CU Control unit

D

DM data manager

E

e 602 cobas e 602 module for immunoassay analysis

e6-1, e6-2, e6-3 First, second, third e 602 module of the instrument

e.g. exempli gratia – for example

H

HIS Hospital information system

I

ID Identification

i.e. id est – that is to say

Table 3 Abbreviations

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 11

cobas® 8000 data manager

Safety classification

This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the ANSI

Z535.6 Standard. Familiarize yourself with the following meanings and icons:

Generic hazard statements

The safety alert symbol by itself without a signal word is used to promote awareness to

hazards which are generic or to direct the reader to safety information provided elsewhere

in the document.

WARNING

Warning

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

injury.

CAUTION

Caution

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

injury.

ISE Ion Selective Electrode; also used for ISE module

ISO International Organization for Standardization

IVD In Vitro Diagnostic

IVDD In Vitro Diagnostic Directive

L

LIS Laboratory information system

N

n/a not applicable

P

PC/CC ProCell / CleanCell, system reagents used on the e 602 module

PNU Precinorm Universal, a Roche QC material

PPU Precipath Universal, a Roche QC material

Q

QC Quality Control

S

SB StandBy

SD Standard deviation

SPR Special Reagent

STAT Short Turn-Around Time

Std Standard, commonly used for calibrator

SU rack Sampler Unit, the rack loader/unloader

(SU is used on the Overview menu)

W

WEEE European Waste Electrical and Electronic Equipment Directive

Abbreviation Definition

Table 3 Abbreviations

cobas® 8000 data manager

Roche Diagnostics

12 Operator's Manual · Version 1.03, Revision 1

NOTICE

Notice

Indicates a hazardous situation which, if not avoided, could result in damage to

equipment.

Tip

Indicates additional information on correct use or useful tips.

Safety precautions

Generic hazard statements

Particular attention must be paid to the following safety precautions. If these safety

precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is

important.

Operator qualification

Operators are required to have a sound knowledge of relevant guidelines and

standards as well as the information and procedures contained in the Operator’s

Manual.

o Do not carry out operation and maintenance unless you have been trained by

Roche Diagnostics.

o Carefully follow the procedures specified in the Operator’s Manual for the

operation and maintenance of the data manager.

o Leave maintenance, installation or service that is not described in the Operator’s

Manual to Roche Service.

Safe and proper use of the data manager

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

remains available for use. It must be easily accessible at all times.

Installation o Installation must be performed by Roche Service only.

o Leave installation tasks that are not described in the Operator’s Manual to Roche

Service.

Approved parts Use of non-approved parts or devices may result in malfunction and may render the

warranty null and void. Only use parts and devices approved by Roche Diagnostics.

Third-party software Installation of any third-party software that is not approved by Roche Diagnostics

may result in incorrect behavior of the data manager. Do not install any non-

approved software.

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 13

cobas® 8000 data manager

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may damage the data manager or lead

to data loss. Perform regular backups of measurement results. Operate only with an

uninterruptible power supply. Do not switch off power while the PC accesses the

hard disk or other storage device.

Safety summary

This safety summary contains the most important and general warning, caution, and

notice messages.

Warning messages

WARNING

List of warning messages

Before operating the data manager, read the warning messages contained in this

summary carefully. Failure to observe them may result in death or serious injury.

Electrical safety

WARNING

Electrical shock by electronic equipment

Removing the covers of electronic equipment can cause electric shock, as there are high

voltage parts inside. In addition, opening the top cover during operation can also cause

electric shock.

Do not attempt to work in any electronic compartment.

Only authorized and qualified Roche personnel are to perform an installation, service

and repair of the system.

Caution messages

CAUTION

List of caution messages

Before operating, read the caution messages contained in this summary carefully.

Failure to observe them may result in minor or moderate injury.

Fatigue due to long hours of operation

CAUTION

Fatigue due to long hours of operation

Looking at the monitor screen over an extended period of time may lead to eye strain or

body fatigue.

Take a break for 10 to 15 minutes every hour to relax.

Avoid spending more than 6 hours per day looking at the monitor screen.

cobas® 8000 data manager

Roche Diagnostics

14 Operator's Manual · Version 1.03, Revision 1

Malfunction due to interfering electromagnetic fields

CAUTION

Malfunction of the data manager and incorrect results due to interfering

electromagnetic fields

This data manager has been designed and tested to CISPR 11 Class A. In a domestic

environment it may cause radio interference, in which case, you may need to take

measures to mitigate the interference.

The electromagnetic environment should be evaluated prior to operation of the device.

Do not operate the data manager in close proximity to sources of strong

electromagnetic fields (for example unshielded intentional RF sources), as these may

interfere with the proper operation.

Data security

CAUTION

Unauthorized access and data loss due to malicious software and hacker attacks

Portable storage media can be infected with and transmit computer malware, which may

be used to gain unauthorized access to data or cause unwanted changes to software.

The cobas

®

8000 data manager is not protected against malicious software and hacker

attacks.

The customers are responsible for IT security of their IT infrastructure and for protecting it

against malicious software and hacker attacks. Failure to do so may result in data loss or

render the cobas

®

8000 data manager unusable.

Roche recommends the following precautions:

o Allow connection to authorized external devices only.

o Ensure that all external devices are protected by appropriate security software.

o Ensure that access to all external devices is protected by appropriate security

equipment. Roche strongly recommends the use of a cobas IT Firewall.

o Do not copy or install any software on the cobas

®

8000 data manager unless it is

part of the system software or you are instructed to do so by Roche Service.

o If additional software is required, contact Roche Service to ensure validation of the

software in question.

o Do not use the USB ports to connect other storage devices unless you are

instructed to do so by official user documentation or by Roche Service.

o Exercise utmost care when using external storage devices such as CDs, or DVDs.

Do not use them on public or home computers while connecting to the

cobas

®

8000 data manager.

o Keep all external storage devices in a secure place and ensure that they can be

accessed by authorized persons only.

Notices

NOTICE

List of notices

Before operating, read the notices contained in this summary carefully. Failure to

observe them may result in damage to equipment.

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 15

cobas® 8000 data manager

Circuit breakers and fuses

NOTICE

Damage to the data manager due to improper use

Should one of the circuit breakers or fuses blow, do not attempt to operate the data

manager before contacting either Roche Service or technical support.

Disposal of the equipment

Disposal of control unit components

Components of your control unit (such as the computer, monitor, keyboard) which are

marked with this symbol are covered by the European Directive on Waste Electrical and

Electronic Equipment (WEEE, 2002/96/EC).

Prior to disposal, all patient data and information must be erased according to local

regulations.

These items must be disposed of via designated collection facilities appointed by

government or local authorities.

For more information about disposal of your old product, please contact your city

office, waste disposal service or Roche Service.

Constraint:

It is left to the responsible laboratory organization to determine whether control unit

components are contaminated or not. If contaminated, treat them in the same way as

the analytical modules of the cobas® 8000 modular analyzer series.

cobas® 8000 data manager

Roche Diagnostics

16 Operator's Manual · Version 1.03, Revision 1

Operation data manager

1 Introduction...................................................................................................................................... 19

2 Pass-through mode........................................................................................................................... 37

3 Routine tasks .................................................................................................................................... 49

4 QC..................................................................................................................................................... 77

5 Routine configuration ...................................................................................................................... 97

6 Test configuration........................................................................................................................... 113

7 System configuration...................................................................................................................... 143

8 Administration ............................................................................................................................... 157

9 Data clean-up and archiving ......................................................................................................... 165

10 Software update installer ............................................................................................................... 189

Roche Diagnostics

Operator's Manual · Version 1.03, Revision 1 19

cobas® 8000 data manager 1 Introduction

Table of contents

Introduction 1

This chapter provides an introduction to the data manager.

In this chapter

Chapter

1

Introduction to the cobas

®

8000 data manager.................................................................21

The cobas

®

8000 data manager and associated workflows..............................................22

Validation ........................................................................................................................22

Pass-through mode for patient results ..................................................................23

QC ....................................................................................................................................23

Pass-through mode for QC results........................................................................23

Pass-through mode for calibration results............................................................23

Starting the cobas

®

8000 data manager..............................................................................24

Starting the data manager .............................................................................................24

Screen sharing via Sidebar ............................................................................................24

Sidebar screen overview................................................................................................25

TraceDocViewer.......................................................................................................25

Saving screenshots in the data manager ...............................................................26

Creating issue reports..............................................................................................26

Remote support status.............................................................................................26

Software update installer (SUI)..............................................................................27

Host interface connection status symbol..............................................................27

Shutting down the data manager ...........................................................................27

Restarting data manager .........................................................................................27

Changing the Date and time settings ....................................................................28

USB storage devices.................................................................................................28

The cobas

®

8000 data manager interface ...........................................................................29

Default workplaces ...............................................................................................................31

Standard tasks .......................................................................................................................32

Selecting a workplace.....................................................................................................32

Selecting components and sub-components ..............................................................32

Searching for data...........................................................................................................32

Filters .........................................................................................................................32

Search criteria dialog box .......................................................................................32

Wild card searches ...................................................................................................33

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20 Operator's Manual · Version 1.03, Revision 1

1 Introduction cobas® 8000 data manager

Table of contents

eLibrary document searches...................................................................................33

Working with tables.......................................................................................................34

Simple sorting...........................................................................................................34

Group sorting ...........................................................................................................34

Selecting table rows .................................................................................................35

Showing and hiding table columns........................................................................35

Exporting and printing tables ................................................................................35

Reloading table data ................................................................................................36

Using the Online help....................................................................................................36

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Roche cobas 8000 Data Manager User manual

Roche cobas 8000 Data Manager User manual

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