Roche cobas 8000 Data Manager User manual

cobas

®

8000 data manager

Operator's Manual version 6

Software version 1.05

cobas® 8000 data manager

Roche Diagnostics

2 Operator's Manual · version 6

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.

Manual

version

Software

version

Revision

date

Main changes

1.0 1.0 June 2009 First version of this Operator’s Manual.

1.01 1.01 January

2010

e-module support

1.02 1.02 October

2010

Terminology: "Technical validation" changed to

"Validation", "Instrument flag" changed to "data

alarm".

User Interface: New information window system

message for software update package, buttons

changed.

Golden rule rounding implemented.

Pass-through mode: new chapter in operator

manual.

TraceDoc chapter enhanced and renamed to "Data

cleanup and archiving".

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.

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.

Version 5 1.04 Feb -2014 Restructured manual.

Added workplace overview chart in chapter

Introduction.

Updated procedures on software update, creating a

calculated test, setting up a non-Roche QC

material.

Data alarms chapter added.

Version 6 1.05 Aug-2014 Updated procedures on software update, creating a

calculated test.

U For more information on the latest changes,

see What is new in this version of the manual?

(p. 13).

Table 1 Revision history

Roche Diagnostics

Operator's Manual · version 6 3

cobas® 8000 data manager

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.

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:

Complies with the IVD directive 98/79/EC.

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

CUS

®

cobas® 8000 data manager

Roche Diagnostics

4 Operator's Manual · version 6

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

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Operator's Manual · version 6 5

cobas® 8000 data manager

Roche Diagnostics

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Operator's Manual · version 6 7

cobas® 8000 data manager

Table of contents

Document information 2

Contact addresses 4

Table of contents 7

Preface 13

Safety classification 16

Safety precautions 17

Safety summary 18

Disposal of the equipment 20

Operation data manager

1 Introduction

Introduction to the cobas

®

8000 data manager 27

The cobas

®

8000 data manager and associated

workflows 28

Start up and shutdown procedures 30

Restarting the data manager 31

The cobas

®

8000 data manager interface

(without sidebar) 32

Accessing an application from the sidebar 34

Features accessed via Sidebar 36

Working with the interface 39

2 Routine tasks

Working with samples 47

Working with tests 56

Validating test results manually 63

Results reporting 66

Masking and unmasking tests 67

QC Routine tasks 71

3 QC Configuration

Configuration of QC Parameters 79

4 Test configuration

Working with tests and reference ranges 95

Calculated tests 106

5 General configuration

Overview 113

Managing workplaces 114

Managing users 116

Configuring profiles 119

Masking profiles 121

Configuring data alarms to ‘block QC’ 123

Changing date and time 124

Synchronizing data manager with TSN agent 126

Instrument 127

Configuring SOPs 130

6 Pass-through mode configuration

Introduction 139

Using the pass-through modes 140

Pass-through mode activation 141

Pass-through mode for patient results 142

Pass-through mode for QC results and

calibration results 145

Pass-through mode data flow scenarios 146

7 Data clean-up and archiving

Introduction 153

Data retrieval and storage 154

Data clean-up 155

Uploading data to Roche 158

Data archiving 160

Data purging 163

Browsing data using the TraceDocViewer 164

TraceDocViewer reference 168

8 Software update installer

The software update installation (SUI)

process 181

Update procedures 187

Troubleshooting and recovery 196

9 Data alarms

The meaning of the data alarms 201

Alarms for Routine or STAT samples 208

Alarms for Control and Calibration samples 212

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cobas® 8000 data manager

Software description

10 Routine windows

Host backup 223

Search patient 225

Sample overview 226

Sample comment 231

Sample history 232

Sample tracking 233

Previous results 234

Test comment 235

Test history 236

Test details 237

Request dilution for test: <x> 239

Day list 240

Search criteria 245

Validation 246

Test mask overview 250

Result entry 252

System status 253

System alarms 255

System status 257

System alarm 258

11 QC routine windows

QC Routine 261

Insert comment 265

Result details 266

QC standby bottles 268

12 QC Parameter windows

QC material 271

Insert QC material 276

Copy control 278

Control history 279

Westgard rules 280

Insert Westgard rule / Edit Westgard rule 283

Westgard rules assignment 286

History 287

QC data alarm 288

QC configuration 289

Calibration method rules 290

Insert calibration method rule 291

Calibration recommendations 292

13 Routine configuration windows

Sample type 295

Edit sample type 297

Test groups 298

Insert/edit test group 300

Profiles 301

Profile 302

Assign tests 303

Profile in profile 304

Masking profiles 305

Masking profile 306

SOP configuration 307

Create popup / Popup details and assignment 308

Processing intervals 309

Processing intervals 310

14 Test configuration windows

Tests / reference ranges 315

Test / reference ranges 316

Reference range for <x> 322

Insert Action 324

Text input 325

Limits of detection 326

Component for test units 327

Test units 328

Configuring test measurement units 329

Conversion factor 331

Formula definition 332

Parameters 335

Managing formulas 336

Formula list 341

Log 343

History 344

Settings 345

Comment texts 346

Comment text groups 347

Managing comment texts 349

Comment texts 352

Comment group 353

Comment group assignment 354

15 System configuration windows

Organization 357

Organization 358

System configuration 359

Instrument 364

Tasks 367

Configuration 368

Edit configuration 369

System message 370

XML information 372

Log files 373

Log information 375

Log information per application 376

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cobas® 8000 data manager

16 Administration windows

Workplaces 379

Workplaces 380

Global properties 381

Assignment component - workplace 382

User profile 383

User ID 384

User/Workplaces 385

Assignment user - workplace 386

User / Icons 387

Assignment user - icons 388

User system rights overview 389

Copy authorizations 390

17 Service windows

Password settings 395

Password profile 396

Instrument groups 397

Edit instrument group 398

Assignment instrument group - instrument 399

Data alarms 400

Edit data alarm 401

Icons 402

Icon 403

Gender 404

Gender 405

Priorities 406

Priority 407

Sample status 408

Sample status 409

Test status 410

Test status 411

Validation status 412

Validation status 414

Service-related configuration 416

System messages overview 422

System message parameters 425

Edit parameter 426

Active level 427

Special configuration 428

System information configuration detail 430

Real time alarms configuration 431

Glossary

18 Glossary

Index

Index 439

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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.

What is new in this version of the manual?

This section summarizes the new and changed features described in this manual.

Control material o In the QC Parameter workplace the following names are changed.

Control overview tab to QC material overview tab. Field control name to QC

material name. On the shortcut menu, Insert control material to Insert QC

material, and Delete control material to Delete QC material.

U Configuration of QC Parameters (p. 79)

Test configuration o If the value in the Symbolic name field in a calculated test is equal to a Roche or

Development Channel test number, the Roche test cannot be installed to the data

manager. An information is added to the task to enter the Symbolic name for

calculated tests according to the guidelines.

U Creating a calculated test (p. 106)

TSN agent o On the TSN agent tab of the Service-related configuration component, you can

choose new upload filters for patient results that are related to the instrument

module, for example ISE, Clinical chemistry or Immunoassay.

U Uploading data to Roche (p. 158)

TSN agent o On the TSN agent tab of the Service-related configuration component, choose

the Send IA patient results option to send the test results for all heterogeneous

immunoassays (HET-IA) to the TSN agent. If the data point upload option on the

control unit is activated, the data manager forwards the test result with the data

points to the TSN agent. The upload support the ASTM and the HL7 host

protocol. Data points can be sent from the data manager for all e-modules of the

cobas® 8000 modular analyzer.

U Sending immunoassay data points to the host (p. 158)

Forward instrument status o The Forward instrument status option is used to send information about the

instrument status and the test availability to the host automatically. The option

allows the host to know the status of the different modules and to organize the

sample orders turnaround time in the most optimal way.

U Forwarding instrument status to the host (p. 158)

cobas® 8000 data manager

Roche Diagnostics

14 Operator's Manual · version 6

How to use this manual

Q

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.

The instrument software offers two help features:

o Help, accessed via menu bar: opens on title page.

o Help, accessed via F1 key: opens help page related to current window

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.

Q

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.

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:

Symbol Comment

o List item

P Start of procedure

S End of procedure

Table 2 Symbols used for easy recognition of information

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Operator's Manual · version 6 15

cobas® 8000 data manager

Abbreviations The following abbreviations are used:

U Cross-reference

f Navigation path indication

Q Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

Symbol Comment

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

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

Table 3 Abbreviations

cobas® 8000 data manager

Roche Diagnostics

16 Operator's Manual · version 6

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

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

injury.

CAUTION

Caution

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

injury.

NOTICE

Notice

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

equipment.

Q

Tip

Indicates additional information on correct use or useful tips.

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

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Operator's Manual · version 6 17

cobas® 8000 data manager

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.

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.

cobas® 8000 data manager

Roche Diagnostics

18 Operator's Manual · version 6

Safety summary

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

notice messages.

Warning messages

WARNING

List of warning messages

r 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.

r Do not attempt to work in any electronic compartment.

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

and repair of the system.

Caution messages

CAUTION

List of caution messages

r 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.

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

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

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Operator's Manual · version 6 19

cobas® 8000 data manager

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.

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

r 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.

r 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 or

Fortigate 400.

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

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

observe them may result in damage to equipment.

cobas® 8000 data manager

Roche Diagnostics

20 Operator's Manual · version 6

Circuit breakers and fuses

NOTICE

Damage to the data manager due to improper use

r 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).

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

regulations.

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

government or local authorities.

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

office, waste disposal service or Roche Service.

r 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.

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Roche cobas 8000 Data Manager User manual

Roche cobas 8000 Data Manager User manual

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