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cobas s 201 system

Roche cobas s 201 system User manual

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  • What are the three applications included in the Roche PDM software?
    What is the purpose of the PDM Configuration application?
    What information can be stored in the Address topic of the PDM Configuration application?
    What options can be configured in the Donors topic of the PDM Configuration application?
    What is the purpose of the LIS Export topic in the PDM Configuration application?
    What determines whether a Library Plate is prepared during Primary Pooling and whether Secondary Pooling is performed from the Library Plate?
    How can the laboratory administrator determine which Primary Pooling methods are available for small pools?
03/2008, version 1.0 1.1
PDM Software
1
Overview
Roche PDM software includes three applications that allow the system
administrator to configure the Roche PDM system and to monitor
system activity.
This section describes these administrative applications.
Refer to Section 2 for a description of the Archive Management
application, which is used to retrieve, review, and print archive records.
In addition to these functions certain Roche PDM Pooling
Manager and Data Manager functions are restricted to users
assigned a LABADMIN or higher role (refer to page 1.34).
The administrative application screens have the same layout and
contain the same global command buttons as other PDM
applications. Refer to Screen Layout in the cobas s 201 system
Hardware and Software Reference Manual for WNV for details.
Application Name Purpose
PDM Configuration • Store the laboratory name and address.
• Configure donor accept and release options.
• Setup an FTP client to transmit LIS export files.
• Determine Library Plate usage.
• Select pooling methods.
• Enable UDECs.
• Select the donor tube carrier size.
• Configure user authentication parameters.
• Configure the LIS export file.
User Administration • Create a user account.
• Enable or disable a user account.
• Retire a user account.
Report Manager • Retrieve, review, and print audit records.
1.2 03/2008, version 1.0
PDM Configuration
The PDM Configuration application allows the laboratory administrator
to set certain configuration settings.
Additional settings, including archive and backup options, are set
during installation. Contact your Roche representative if one of
these settings must be changed.
Click the Config button in the global command button area in other
PDM applications to start the PDM Configuration application
(Figure 1.1).
Figure 1.1
PDM Configuration Application
Navigator Panel Work Area Global Command
Buttons
PDM Software
03/2008, version 1.0 1.3
The PDM Configuration screen is divided into two panels:
Once a field record is selected the field value can be updated by clicking
the Browse button , highlighting an entry in the Selection List dialog
box (Figure 1.2), and then clicking OK.
If the Browse button is not available, the field can be updated by
typing a new value in the Value text box.
The PDM Configuration window contains the following local command
buttons:
Panel Description
Navigator Panel Contains a hierarchical tree format similar to
that used by Windows Explorer. A dotted
yellow circle before an item indicates the
item is a category or topic. Click the plus
symbol before a category or topic to see
related field items.
Work Area Displays the name and description of the
selected category or topic. Displays field
records and allows field values to be viewed
and modified.
Note: Only the Entry tab is accessible.
Figure 1.2
Example Selection List Dialog Box
Button Function
Apply Saves changes to temporary storage.
Save All Displays the Electronic Signature Form.
Applied changes are saved when the form is
signed.
Discard Clears all entries made since the last save
operation.
1.4 03/2008, version 1.0
Storing Address Information
The Address topic allows the laboratory name and address to be entered.
The laboratory name and address are displayed on Roche PDM Pooling
Manager and Data Manager reports.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then expand the
Address topic (Figure 1.3).
3 Select the field to be updated:
4 Type a new value in the Value text box, and then click Apply.
5 Click Save all. The Electronic Signature Form is displayed.
6 Enter the assigned login ID and password and click Sign.
Figure 1.3
Address Topic
Address Topic
Apply
Save all
Name Value
Field Description
Address The laboratory address.
Name The laboratory name.
PDM Software
03/2008, version 1.0 1.5
Configuring Donor Options
The Donors topic allows the auto accept feature to be enabled or disabled,
and limits to be entered for the donor tube barcode reuse time and the
donor sample viability time.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then expand the
Donors topic (Figure 1.4).
3 Select the field to be updated:
Figure 1.4
Donors Topic
Donors Topic
Apply Save all
Browse Button
Field Description
Auto Accept Ye s if donor results should be automatically accepted
without operator review. No if results must be
manually accepted using the Accept button in the
PDM Data Manager Donor Review tab.
Donor
Release in
days
The reuse time. The period of time that must elapse
after final results for a donor tube have been received
before that donor tube barcode ID can be reused.
The default is 365 days.
1.6 03/2008, version 1.0
4
Click the
Browse
button ,
select a value from the Selection List dialog
box, and then click OK.
If the Browse button is not available, type the new value directly
into the Value text box.
5 Click Apply.
6 Click Save all. The Electronic Signature Form is displayed.
7 Enter the assigned login ID and password and click Sign.
Donor
Timeout in
days
The viability time. The elapsed time between initial
pipetting and assignment of final results. If a result is
not accepted within the viability time limit, the sample
is automatically assigned a status of Complete,
Unresolved, unless the sample tested reactive in an
individual pool (Primary Pool of 1 or Resolution Pool).
In that case, the sample is automatically assigned a
status of Complete, Reactive. The default is 10 days.
Donor
Timeout
remaining
days
The timeout notification period. The number of days
before a donor sample times out that a notification
message is displayed.
Field Description
PDM Software
03/2008, version 1.0 1.7
Setting Up an FTP Client for LIS Export
The LIS Export topic allows the auto transmit feature to be enabled or
disabled, and an FTP client to be configured to transmit LIS export files to
an FTP server.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then expand the LIS
Export topic (Figure 1.5).
3 Select the field to be updated:
Figure 1.5
LIS Export Topics
LIS Export Topic
Apply Save all
Browse Button
Field Description
Auto
Tra nsmit
Yes if accepted donor results should be automatically
transmitted to the LIS. No if accepted results must
be manually transmitted using the Send to LIS
button in the PDM Data Manager Donor Review tab.
FTP Connect
TimeOut (in
seconds)
Value in seconds for the timeout of the connect
operation. If a response is not received after this
number of seconds, the FTP client aborts the
connection attempt. The default is 10 seconds.
1.8 03/2008, version 1.0
4
Click the
Browse
button ,
select a value from the Selection List dialog
box, and then click OK.
If the Browse button is not available, type the new value directly
into the Value text box.
5 Click Apply.
6 Click Save all. The Electronic Signature Form is displayed.
7 Enter the assigned login ID and password and click Sign.
FTP
Password
Password to be used when connecting to the FTP
server.
FTP Polling
Interval (in
seconds)
Frequency to check for files that may be pending
transmission to the FTP server.
FTP Server The FTP server address e.g., myftp.myserver.com
FTP User User name to be used when connecting to the FTP
server.
Use Format for the LIS export file. Options are Version 1.1
Mode (DOMS format) and Configurable. Refer to
Configuring the LIS Export File on page 1.22 for
additional information.
Field Description
PDM Software
03/2008, version 1.0 1.9
Determining Library Plate Usage
The Library Plate topics allow the laboratory administrator to determine
whether a Library Plate is prepared during Primary Pooling and whether
Secondary Pooling is performed from the Library Plate.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then expand the
Library Plate WNV topic (Figure 1.6).
3 Select the pooling method.
Primary Pools of 1 is selected in Figure 1.6.
4
Click the
Browse
button ,
select On or Off from the Selection List dialog
box, and then click OK.
Figure 1.6
Library Plate Topics
Apply Save all
Browse Button
Library Plate
Topics
Setting Primary Pooling Secondary Pooling
On A Library Plate is prepared
to save an aliquot of each
donor sample in case
Secondary Pooling is
required.
Secondary Pooling must be
performed from the Library
Plate if the well is usable.
1.10 03/2008, version 1.0
5 Click Apply.
6 Click Save all. The Electronic Signature Form is displayed.
7 Enter the assigned login ID and password and click Sign.
Off No Library Plate is
prepared.
Secondary Pooling is
performed from the donor
tube.
Setting Primary Pooling Secondary Pooling
PDM Software
03/2008, version 1.0 1.11
Selecting Pooling Methods
The laboratory administrator can determine which Primary Pooling
methods are available for small pools.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then expand the
Pooling topic.
3
Select a pooling method in the left panel, e.g.,
Primary Pools of 1 (WNV
), and
then click the
Browse
button to display the
Selection List
dialog box
(
Figure 1.7).
4 Choose Ye s to add the selected pooling method to the list of available
pooling options or select No to exclude the pooling method.
5 Click OK to close the Selection List dialog box.
6 Click Apply.
7 Repeat steps 3 through 6 for the listed pooling methods.
8 Click Save all. The Electronic Signature Form is displayed.
9 Enter the assigned login ID and password and click Sign.
Figure 1.7
Pooling Topic
Small Pools
Browse Button
1.12 03/2008, version 1.0
Methods that are enabled (value Ye s ) appear as Primary Pooling buttons
in the Pooling Wizard (Figure 1.8).
Secondary Pooling options are determined by the system and cannot
be modified by the laboratory administrator.
Figure 1.8
Pooling Tab
Primary Pooling Buttons Secondary Pooling Buttons
PDM Software
03/2008, version 1.0 1.13
Enabling UDECs
The cobas s 201 system supports processing of user-defined external
controls (UDECs). The User Defined External Controls topic allows the
laboratory administrator to specify whether the laboratory can process
UDECs and to specify the position of the UDECs in the SK24 rack.
If UDECs are enabled, the operator is prompted at the beginning of
each pooling run whether to include UDECs in that run.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then expand the User
Defined External Controls topic (Figure 1.9).
3 Select WNV.
4 Select UDEC 1.
Up to five UDECs can be configured for each assay.
Figure 1.9
User Defined External Controls Topic
UDEC Topic
1.14 03/2008, version 1.0
5
Select a UDEC field:
6
Click the
Browse
button ,
select a value for the field, and then click
Apply.
7 Repeat steps 5 and 6 for UDEC 2 through UDEC 5.
8 In the left panel, select the Use UDECs field.
9 Click the
Browse
button
and select Ye s to enable use of UDECs. Select
No to disable UDECs.
An individual UDEC can be enabled (Yes) or disabled (No) by the
selection in the In Use field. The Use UDECs field selection affects
all UDECs, overriding individual settings.
10 Click Apply.
11 Click Save all. The Electronic Signature Form is displayed.
12 Enter the assigned login ID and password and click Sign.
Field Description
Batch Position The position (1 to 22) that the UDEC S-tube will
occupy in the SK24 rack.
Batch Rack Not currently used. UDECs are always pipetted
in rack 1 during a pipetting run.
In Use Enable (Ye s) or disable (No) use of this UDEC. All
UDECs can be enabled or disabled with the Use
UDEC field (see below).
Name A unique name for the UDEC. The name will be
used on screens and reports.
PDM Software
03/2008, version 1.0 1.15
Entering UDEC Barcodes, Lot Numbers, and Expiration Dates
When UDECs are loaded on the pipettor deck, the barcode reader scans
the barcodes of each tube and compares the scanned value with the UDEC
barcodes defined by the laboratory administrator. UDEC barcodes, lot
numbers, and expiration dates are entered using the PDM Data Manager
application UDEC tab (Figure 1.10).
In order to access the UDEC tab, the Data Management
workstation must be restarted after UDECs are enabled in the PDM
Configuration application (page 1.13).
Information in the User Defined External Control panel, at the top of the
UDEC tab, is specified in the PDM Configuration application.
Figure 1.10
PDM Data Manager UDEC Tab
UDEC Tab
Selected
Test
User Defined External Control Panel
Field Description
(1st field) Test name (selected in the left panel).
Batch Position SK24 rack position for the S-tube that will contain
the UDEC.
Expanded
Batch Position
Not currently used.
Expanded
Batch Rack
Not currently used. UDECs are always pipetted in
rack 1 during a pipetting run.
1.16 03/2008, version 1.0
Adding UDECs
1
Access the PDM Data Manager application.
Click the DMS button in the global command button area if
another PDM application is currently running.
2 Select the UDEC tab.
3 Select WNV.
4 Select the test in the left panel and click New.
The UDEC Barcode Definition dialog box is displayed (Figure 1.11).
5 Type the control test name.
6 Type or scan the barcode ID.
The Remaining Length field updates as each character is typed,
indicating the maximum number of additional characters that the
barcode can contain.
The barcode on the control tube must match a barcode defined
for the assay if a UDEC is loaded during a pipetting run.
7 Type the control lot number.
This lot number will appear on screens, in reports, and be
included in the export file to allow statistical tracking.
8 Type the expiration date using the indicated format.
If a UDEC is expired, it will not be processed.
9 Click Apply.
The new test is added to the list in the left panel.
Figure 1.11
UDEC Barcode Definition Dialog Box
PDM Software
03/2008, version 1.0 1.17
Editing a UDEC Definition
1
Access the PDM Data Manager application.
2 Select the UDEC tab.
3 Select WNV.
4 Select the test in the left panel and click Edit.
The UDEC Barcode Definition dialog box is displayed (Figure 1.11).
5 Update the desired fields then click Apply.
The test name cannot be modified.
Deleting a UDEC
1
Access the PDM Data Manager application.
2 Select the UDEC tab.
3 Select WNV.
4 Select the test in the left panel and click Delete.
5 Click Ye s to confirm the deletion.
1.18 03/2008, version 1.0
Selecting the Donor Tube Carrier Size
The Donor Carrier Size setting determines the type of donor tube carrier
that can be loaded onto the Hamilton Microlab STAR IVD / STARlet IVD
Pipettor.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the General category and then select the Donor
Carrier Size field (Figure 1.3).
3
Click the
Browse
button ,
select an option from the Selection List dialog
box, and then click OK.
Figure 1.12
Donor Carrier Size Field
Apply Save all
Browse Button
Donor Carrier
Size Field
Setting Description
24 Only 24-position donor tube carriers, containing
10 mL (16 mm x 100 mm) donor tubes, can be loaded.
32 Only 32-position donor tube carriers, containing
5 mL (12 mm x 75 mm) or 7 mL (13 mm x 100 mm)
donor tubes, can be loaded.
PDM Software
03/2008, version 1.0 1.19
4 Click Apply.
5 Click Save all. The Electronic Signature Form is displayed.
6 Enter the assigned login ID and password and click Sign.
Autodetect Either 24-position or 32-position donor tube carriers
can be loaded. The system automatically detects the
type when the first carrier is loaded, and that type
must then be used for the remainder of the run.
Setting Description
1.20 03/2008, version 1.0
Configuring User Authentication Parameters
User Authentication parameters set limits on the size and complexity of
user account login IDs and passwords, and determine password expiration
and inactivity time limits.
1 Click the Config button to start the PDM Configuration
application.
2 In the left panel, expand the User Authentication topic (Figure 1.13).
3 Select the fie
ld to be updated:
Figure 1.13
User Authentication Topic
Apply Save all
User
Authentication
Topic
Field Description
Maximum failed logins Maximum number of failed login
attempts before an account is
temporarily disabled for ten minutes.
Maximum length of
LoginID
Maximum number of characters that
a login ID can contain.
Maximum length of
Password
Maximum number of characters that
a password can contain.
Minimum length of
LoginID
Minimum number of characters that a
login ID must contain.
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