Roche cobas c 501 User manual

cobas 6000

TraceDocArchiver

Operator´s Manual

Software Version 1.03

Roche Diagnostics

Operator´s Manual · Version 1.3 3

cobas 6000 TraceDocArchiver

Table of contents

Document information .......................................................................................................5

Limited warranty .................................................................................................................5

Welcome to cobas 6000 TraceDocArchiver ....................................................................6

Preface .............................................................................................................................6

Important information .................................................................................................7

System requirements .....................................................................................................8

Package content .............................................................................................................8

Starting the program ...........................................................................................................9

User interface overview ....................................................................................................10

The heading area .........................................................................................................11

The error/information area ........................................................................................12

The tab navigation area ..............................................................................................12

The tab content area. ...................................................................................................12

Import/Drop .......................................................................................................................13

First run ........................................................................................................................13

Import a SVP (backup) file ........................................................................................14

Multiple instruments defined ....................................................................................16

Mass import .................................................................................................................17

Imports history ..................................................................................................................18

Re-import .....................................................................................................................19

Export ..................................................................................................................................20

Optical export ..............................................................................................................20

Network export ............................................................................................................22

Configuration .....................................................................................................................23

Instrument Management ...........................................................................................24

Misc (maintenance) ...........................................................................................................26

Purge old data ..............................................................................................................26

System messages ..........................................................................................................27

Installing the cobas 6000 TraceDocArchiver ................................................................29

Items needed ................................................................................................................29

Installation ....................................................................................................................29

Uninstalling ..................................................................................................................34

Update the program ....................................................................................................34

Appendix .............................................................................................................................35

Appendix A (Issue resolving) ....................................................................................35

Find the debug logfile ...........................................................................................35

Reset user settings to default ................................................................................35

Change debug log level .........................................................................................35

Removing lingering lock file ................................................................................35

Appendix B (System Message messages) .................................................................36

System Message messages ..........................................................................................36

Message reference across application .......................................................................36

Appendix C (Information for IT supporters) .........................................................39

Appendix D (Technical Documentation) ................................................................41

Database File Location .........................................................................................41

TraceDoc structure ...............................................................................................42

Traceability claim ..................................................................................................43

Export data table definition C6kTDocArchiverOutput.db3 ............................ 44

Export data index definition C6kTDocArchiverOutput.db3 .......................... 49

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Roche Diagnostics

Operator´s Manual · Version 1.3 5

cobas 6000 TraceDocArchiver

Document information

Revision history

Edition notice This Operator´s Manual is for users of the cobas 6000 TraceDocArchiver.

Every effort has been made to ensure that all the information contained in this

document is correct at the time of printing. 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 software will render the warranty or service

agreement null and void.

Intended use cobas 6000 TraceDocArchiver (the program) allows a user to process cobas 6000

analytical system *) backup files to derive sample result dependency information to

trace reagent, control and calibration material use as well as time based dependency

of sample results from calibration- and control measurements.

*) Future program updates may add support for more instruments.

Local regulation Regional restrictions and obligations may apply as per contract or license agreement

for the usage the user has agreed to oblige when using this program.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS C, COBAS INTEGRA, ELECSYS and LIFE NEEDS ANSWERS are

trademarks of Roche.

All other trademarks are the property of their respective owners.

Limited warranty

For US customers only.

Roche Diagnostics warrants that this product will meet the specifications stated in the

labeling when used in accordance with such labeling and will be free from defects in

material and workmanship until the expiration date printed on the label.

This limited warranty is in lieu of any other warranty, express or implied, including

any implied warranty of merchantability or fitness for particular purpose. In no event

shall Roche Diagnostics be liable for incidental, indirect, special or consequential

damages.

Distribution in USA by:

Roche Diagnostics, Indianapolis, IN,

US Customer Technical Support 1-800-428-2336

Manual Version Software Version Revision date Changes

1.0 1.0.0 November 2013 Initial version

1.1 1.02 September 2015 Update sw version,

add new messages.

1.3 1.03 Jamuar 2016 Update sw version,

add purge icon and

description

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cobas 6000 TraceDocArchiver

Welcome to cobas 6000 TraceDocArchiver

Preface

The cobas 6000 TraceDocArchiver (the program) allows a user to process backup

files from one or more cobas 6000 instrument *), to derive sample result dependency

information to trace reagent, control and calibration material use as well as time

based dependency of sample results from calibration- and control measurements.

Regional restrictions and obligations may apply as per contract or license agreement

for the usage the user has agreed to oblige when using this program.

*) Future program updates may add support for more instruments.

Figure 1 Basic workflow

cobas 6000 CU

backup

file

TraceDoc

Base

TraceDoc

cobas 6000 TraceDocArchiver

Daily Essential Data

Backup (Level 4)

Customer PC

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Install the program

Once

Define the storage location

Once (or if a storage change is needed)

Define the instruments

Once (or if a new instrument is traced)

Add a backup file

Every day or other interval

Search through traceability information

Whenever needed

Monitor seamless import

At intervals

Archive traceability data

Once per months, quarter (depends on data size)

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cobas 6000 TraceDocArchiver

Welcome to cobas 6000 TraceDocArchiver

Important information

Integrity of input data The program will perform basic checks while backup files are processed, however

there are limitations of the consistency detection by the application.

o Ensure integrity of the data backup files in content and filenames while carrying

them from the instrument to the import function of the program.

Intended usage The program processes data solely for the purpose intended i.e. to derive and

document material use and dependency information.

The only original source of result and measurement data is the fully validated and

qualified IVD device (the instrument).

Dependency tracing The program extracts and stores original and derived data from the backup files.

The dependency of sample results from Calibrations is derived via the timely

sequence of events.

The Last QC measurement before the sample result is derived via the timely sequence

of events.

Completeness The program will only capture information and dependency that is present in the

imported backup file.

o Backup data before deleting data. Otherwise, the information will not be available

in the trace records and the dependency may not be accurate.

Privacy The backup files from the instruments may contain patient privacy information.

Backup files are stored at the designated location.

o Ensure the designated location is adequate to store privacy information.

The derived traceability information carries Operator IDs. It does not contain

patient related information other than the Sample ID.

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Welcome to cobas 6000 TraceDocArchiver

System requirements

The cobas 6000 TraceDocArchiver:

o Windows PC hardware

o Windows 7 operating system

o Microsoft Visual C++ 2010 SP1 Redistributable Package

x86 or x64 version depending on whether the 32bit or 64bit version of Windows

is installed.

o Microsoft .NET Framework 4 (Runtime)

o Microsoft .Net Framework (Web Installer)

o CD/DVD Writer optional for archiving

o Approx. 1 GB harddisk space to archive cobas 6000 analytical system data over

time

Package content

o Software CD-ROM containing

O the cobas 6000 TraceDocArchiver software installation program

O this Operator´s Manual as PDF file

o Installation short guide

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cobas 6000 TraceDocArchiver

Starting the program

Start the program like any other Windows program.

The program will start with the screen shown as below.

e

For information about installing the program, see Installing the cobas 6000

TraceDocArchiver on page 29.

Figure 2 Main screen

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User interface overview

A Heading area

Shows basic information about the program (user, file locations)

B Message area

Important or error messages are listed here

C Tab selection area

To select from the available functions and features

D Tab content area

Content shown depends on the tab.

e

For a more detailed description, see:

Import/Drop on page 13

Imports history on page 18

Export on page 20

Configuration on page 23

Figure 3 User interface overview

A

B

C

D

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User interface overview

The heading area

The heading area shows general information of the program, software version, logged

in user and the storage location of the imported files and the derived (TraceDoc)

information.

The user currently logged in.

The laboratory name can be set by the user in Configuration.

The location of the original backup file archive. Clicking the right icon will open the

location in the Windows file explorer.

The location where the derived information (TraceDoc) is stored. Clicking the right

icon will open the location in the Windows file explorer.

The Grand Total of records collected with this application.

Figure 4 Heading example

Figure 5 User

Figure 6 User lab

Figure 7 Location of the original backup file

Figure 8 Location of the derived information

Figure 9 Total output data

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User interface overview

The error/information area

Messages as described in Appendix B may be shown here if needed.

e

For more information about the System Messages, see Appendix B (System Message

messages) on page 36.

The tab navigation area

There are 6 tabs to navigate (clicking will change from one to the other):

Import/Drop Primary working area (to import cobas 6000 instrument backup files)

Imports history Review the history of imported backup files. Re-Import a complete section.

Export Export data for archival purposes

Misc General purpose location (browse Audit files and purge old data from the data

storage)

Configuration Setup instruments, locations and some general parameters

Instruments Review the instrument configuration known by the application (derived from already

imported backup files).

The tab content area.

e

For a more detailed description about the various tabs available, see:

Import/Drop on page 13

Imports history on page 18

Export on page 20

Configuration on page 23

Misc (maintenance) on page 26

Figure 10 Error/Information area

Figure 11 Navigation tabs

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cobas 6000 TraceDocArchiver

Import/Drop

First run

At first run, the user will be asked to provide a location for the application's data store

(Archiver Data Store).

By clicking the Exit button, the application will exit because it cannot run without a

data store. The Provide path button will open a dialog from where the user will be

able to choose the location of a new or an old data store. Several actions are imposed

of a data store like checking the availability of the location, write rights and the

version of the database, if it is present already.

If an action fails, a message appears depending on which one failed (#1001 or #1002

or #1003 or #1004 or #1005 or #1006 or #1007).

After selecting a location for the data store, the application will prepare the location

for proper usage without any additional configuration needed. As all things are now

in place, the application will start.

Figure 12 Data store location is not defined

Figure 13 Select a data store location

Before importing a SVP file for the first time, an instrument must be created. For learning

how to create instruments, check Configuration.

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Import/Drop

Import a SVP (backup) file

A Single Import button

On the Import/Drop tab, the single import will take place by drag and drop of an

SVP file over the import button or by clicking the button and selecting the SVP file

from the dialog (See Figure 15). This dialog contains a filter to help us to find more

easily the files which contain a proper filename for import.

When you drag and drop an SVP file or clicking the import button, the application

will check for the presence of instruments and if the database is not already in use by

other external applications.

Figure 14 Import/Drop tab (Single Import button)

A

Figure 15 Open dialog for a SVP file selection

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Import/Drop

As the import starts, several actions are performed by the application. If a validation

fails, a proper message will be shown (#1010 or #1006).

As it can be viewed from Figure 16, the import operation is providing detailed

information along with its progress. Also, the Import button changes into Cancel

button. Import can be canceled at any time during import by clicking the Cancel

button.

In order to import successfully a file it is important to respect a couple of validation

rules like:

The filename must have the following format.

o SVP_TRANS_4_Date (YYYYMMDD) Time (HHMM) (e.g.

SVP_TRANS_4_201302261727.zip)

o The zip must not be archived in another zip

o The zip must contain all mandatory files

In case the file does not pass one of the previous validation rules a specific message

will be shown on the Import/Drop tab.

Figure 16 View during a normal import

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Import/Drop

Multiple instruments defined

A slight change in the flow is when there are more instruments defined. In this case,

another dialog appears after the SVP file was selected, allowing you to select a specific

instrument for import.

When importing for the first time and multiple instruments are defined, no

instrument is pre-selected. If an import was already performed for the module

information contained in the archive then that instrument will be pre-selected in the

dialog (See Figure 17).

If the user imports an SVP file which can easily be associated with an instrument by

the application, by default, the multiple instruments selection doesn't appear. To

make it appear, a change in the Configuration tab must be performed.

e

See Instrument Management on page 24.

Figure 17 Select an instrument when importing

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cobas 6000 TraceDocArchiver

Import/Drop

Mass import

A Mass Import button

After clicking Mass Import button a window appears (See Figure 19). The user

selects a file from a folder. All valid and new SVP files from that folder are imported.

New SVP file means it hasn't been imported before regardless of the instrument. The

valid SVP files existent in the folder will be imported in chronological order.

The validation rules are those presented before.

e

See Import a SVP (backup) file on page 14.

Figure 18 Import/Drop tab (Mass Import button)

A

Figure 19 Mass import folder selection

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Imports history

As it can be viewed from Figure 20, a secondary progress indicator appeared,

specifying the current SVP that the application is importing and, also, the total

number of SVP files to be imported.

Imports history

All the imports for each instrument of a data store are recorded and their outcome

can be viewed in the Imports history tab.

The left panel represents the data regarding all the imports for an instrument. The

right panel is the re-import functionality.

e

For more information about the re-import functionality, see Re-import on page 19.

Figure 20 Import progress during mass import

Figure 21 Imports history tab view

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cobas 6000 TraceDocArchiver

Imports history

To view the status for an imported SVP file, user must first select an instrument and

then select a date in the calendar corresponding to the creation date of the SVP file.

The import status for that import is shown in the review import section.

For example, for instrument 0002, an import had been performed using the SVP file

from 7th of September 2011.

Re-import

Re-import process consists in recreating the TraceDoc files that correspond to SVP

files with creation dates within the selected period.

Important During Re-import process all existing TraceDoc files will be deleted, and only the

TraceDoc files that correspond to SVP files with creation dates within the selected

period will be recreated.

The selected period will be the one from the selected date at 12:00 AM to present. On

the calendar, all dates corresponding to the creation date of the imported SVP files

are greyed, regardless of instrument.

To re-import, user must first select a start date then press the Re-import button. A

warning dialog will be displayed (#1012) and the user will be able to cancel this

action.

If user continues with this action, Import tab will be displayed and all SVP files

within the period will be re-imported.

If there is no SVP file imported within the selected period, an information message is

shown (#1011) and the process doesn't start.

For example, having ten SVP files imported since the selected date until present, for

an instrument, all ten SVP files will be re-imported. And this happens for all

instruments in the data store. The re-import doesn't delete imports history or stored

SVPs.

Figure 22 Imports performed for instrument 0000

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Export

Export is a way to free up space from the file system of a specific data store and in the

same time to have the data backed-up on the selected medium. It means moving all

the xmls for the corresponding instruments and TraceDocViewer to a different

location. There are two ways of exporting: optical export (to a CD/DVD and Network

export) to another location in the network.

TraceDoc archive size is shown before and after each export. Press Calculate export

size button to obtain the latest export size. Also, there are zones for selecting dates for

exporting.

Taking the tip in consideration, this means that, by selecting certain dates, only the

data created between the two selected dates will be exported.

Also, each export view has a button for triggering the export, enabled only after some

validations are passed. These validations depend on the export type (CD/DVD or

Network), except the condition regarding Export Size.

This means that the export size must be greater than zero. The user must start the

calculation by click the button Calculate export size. If the size is already calculated

and it does not need to be updated, the button is disabled.

Optical export

A Export to a CD/DVD

B Calculate export size button

For the export - the selected dates in the calendar correspond to the dates specified by the

folder's name from TraceDoc folder and not the creation dates for the SVP files.

Figure 23 Optical export view with size not updated

A

B

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