Session Manager DB Software Instructions

Transcription

www.turbotag.com
TurboTag® Session Manager DB Software and DR-1 Reader
Setup and Operating Instructions – Version 2.3.7
Table of Contents
Components of the System....................................................................................................................................2
Computer System Requirements ..........................................................................................................................2
Basic Software Installation Procedure .................................................................................................................2
Starting Up Session Manager DB..........................................................................................................................3
Reading Tags with TurboTag® Session Manager DB ..........................................................................................5
Requirements for Operating in Digital Signature CFR Mode..........................................................................6
IR Mode Display (Reader Not Found) ................................................................................................................7
Reading Actions ..................................................................................................................................................8
Creating Data Files ..............................................................................................................................................9
Opening Data Files from Windows® Explorer.................................................................................................10
Card Reading Errors .........................................................................................................................................11
The Tag Status Panel ........................................................................................................................................11
Switching Between READ and START Modes ...............................................................................................12
Tag Read-Stop and Read-Stop-Restart ...........................................................................................................12
TagMate® Handhelds for Reading Tags .........................................................................................................13
Alarms, Shelf Life and Data Summaries .............................................................................................................14
Temperature Panel ............................................................................................................................................14
Time Panel..........................................................................................................................................................14
Graph Panel .......................................................................................................................................................15
Data Viewing ......................................................................................................................................................16
Dataset Filtering ...............................................................................................................................................17
Database Event Log Configuration and Data Entry ..........................................................................................21
Event Log Data Fields .......................................................................................................................................21
Comments Field.................................................................................................................................................22
General Software Actions ....................................................................................................................................23
Configuring and Starting Tags with TurboTag® Session Manager DB............................................................26
CONFIGURE Screen Inputs (Protocol = Open)..............................................................................................26
Time Panel Inputs..............................................................................................................................................27
Setting the Log Interval and Log Delay...........................................................................................................27
Temperature Panel Inputs ................................................................................................................................28
Starting the Tag’s Logging Operation on the DR-1 .......................................................................................29
TagMate® Handhelds for Configuring and Starting Tags..............................................................................29
Monitoring in Continuous Mode (non-CFR) .......................................................................................................30
Configuration in Continuous Mode (READ)....................................................................................................30
READ-STOP in Continuous Mode....................................................................................................................32
Alarms and Summary Data in Continuous Mode (Selective Analysis)........................................................33
Protocols................................................................................................................................................................36
Importing Protocols ..........................................................................................................................................37
Transferring Protocols and Clock Settings to a TagMate® ...........................................................................38
CFR Mode and Protocols..................................................................................................................................39
TagMate® Limitations under CFR Compliance ...............................................................................................39
ID Code Inputs for Identification of Monitored Products/Locations................................................................40
Data Security Features of T-700 Tags and Files ................................................................................................41
TagMate® Data Capture ........................................................................................................................................42
TagMate QC® Data Capture...............................................................................................................................42
TagMate USB® Data Capture ............................................................................................................................43
Appendix A - Shelf Life Monitoring Option ........................................................................................................44
Setting Up Shelf Life Monitoring......................................................................................................................44
Shelf Life Configuration: Temperature Panel of START Screen ..................................................................44
Shelf Life Configuration: Time Panel of START Screen................................................................................46
Reading Shelf Life Data from Tags..................................................................................................................46
Restart with Shelf Life Carry-Over...................................................................................................................47
Appendix B – Using MKT with TurboTag® ..........................................................................................................48
Appendix C – Setting Log Interval and Log Delay by the Calendar ................................................................50
Appendix D – Use of a Bar Code Scanner for the Database Event Log..........................................................51
Appendix E – Data Retrieval, Viewing, and Printing from Database Records................................................56
Special Aspects of CFR Mode Usage..............................................................................................................58
Appendix F – Creating a Custom Operating Mode for TagMate USB® ............................................................60
Operating Modes ...............................................................................................................................................60
Device Listing ....................................................................................................................................................61
CFR Configuration.............................................................................................................................................63
TagMate® User IDs.............................................................................................................................................66
Appendix G – “Read Protect” for Preventing Unauthorized READ Operations .............................................68
V2.3.7 Session Manager DB February 1, 2010
1
Components of the System
•
TurboTag® DR-1 Desktop Reader, including USB cable 1
•
TurboTag® Session Manager DB Software Installation CD (download)
•
TurboTag® T-700 series temperature monitoring tags
Computer System Requirements
•
Desktop or laptop computer running Windows® XP or Vista operating system.
•
Screen resolution at least 600 x 800 pixels
•
USB port with power (do not use with un-powered multi-port USB hub)
•
4 Gb free disk space and a minimum of 1 Gb RAM.
Basic Software Installation Procedure
•
DO NOT plug in the DR-1 reader to the computer yet!
•
Download the Session Manager DB Software Installation CD from the
www.turbotagdownoad.com web site and follow the instructions for extracting to a folder called
Install_DB. Run setup.exe and click the Install button:
•
Follow all on-screen prompts. Accept license terms and default
options
•
When the installation processes are complete, you will have a
TurboTag® Session Manager DB icon on your desktop. Clicking on
this icon will start the software. Note that a second icon for Session
Manager will appear. This non-database version can also be used on your computer. A
separate manual for this software is included with the installation disk.
1
Some TurboTag® installations may include other TurboTag® supported antenna modules designed for longer distance
reading than the DR-1. This option does not affect any of the instructions in this manual, but may involve installation of a
different driver.
2
•
Connect your DR-1 reader to a powered USB port on the computer. You should see a series
of new device recognition windows appear and disappear the first time that you do this,
indicating that the DR-1 reader has been recognized and is being installed on your computer.
A small program on your computer, called TurboTag® User Manager, has also been installed and is
accessible via the Windows® Start menu. This utility is used by a system administrator to set up the
specific user names that you would use to operate Session Manager DB in CFR mode (for electronic
signature applications). If you intend to use Session Manager DB in an “electronic signature required”
mode, you must know your assigned username. This implies that an administrator has already set up
your username in User Manager. If you have any question, contact your IT system manager.
Some users will be operating Session Manager DB in a mode where electronic signatures are not
required. In this case, there is no requirement for operation of the TurboTag® User Manager software.
See instructions below for bypassing the requirement for operation in this mode (involves simply
canceling the login function at the beginning of each use of the software).
Starting Up Session Manager DB
After software installation as described above, with the DR-1 reader plugged in and properly installed,
double-click the desktop software icon or select All ProgramsÆ TurboTag Æ TurboTag Session Mgr
from the Windows® Start menu. The first thing you will see is the CFR Login Screen on top of the main
software screen:
Clicking here places
Session Manager
DB into a “non-CFR
mode”
If you have been
assigned a user
name, enter it here
Enter your password
here; for first time
use, you will be
prompted to enter a
new password (8
characters minimum)
The login screen will disappear after a non-CFR entry or a CFR entry. After this, the main screen
remains, showing that the software is searching for the DR-1 or another recognized RFID reader:
3
If the reader is found, the screen switches to READ mode as shown below. If no reader is found or if
the CANCEL button is clicked, the IR Mode display results (also shown below). If the DR-1 was
plugged in before starting the software and was not found, it may not have been properly installed. A
properly installed DR-1 can be verified by looking in the Windows® Device Manager listing under
“Ports(COM & LPT)” for a port called CP210x USB to UART Bridge Controller as shown below.
If this port is not visible, repeat the installation process described above, making sure the DR-1 is
unplugged until the last step.
4
Reading Tags with TurboTag® Session Manager DB
Upon startup, after connecting to the DR-1 or another RFID reader, the READ screen is displayed:
If you see this screen you are ready to process T-700 tags on the DR1 reader. Note that when the software has connected to the DR-1
Reader, the status light in the upper right part of the reader case
changes to green (indicating it is ready to perform communication with
T-700 tags).
Status Light
You will see a series of messages in the message box just below the
READ title on the Control Panel. These will convey information about
the actions and readiness of Session Manger DB to perform certain
tasks.
Depending upon the action taken in the CFR login screen at the very
beginning of the program, Session Manager DB will be ready to
perform READ and START actions on specific T-700 tags. If the
program is in CFR mode (active login), then it will be able to perform
all actions on CFR-compliant T-700C or T-700E tags. If it is not in
CFR mode, it will perform most actions on all types of T-700 tags,
excluding CONFIGURE on T-700C or T-700E tags.
5
The status light at the top of the screen will show green if the software has been CFR enabled by the
entry of a valid username and password, and the user name will show as well:
If you do not intend to use the software for a regulated application, simply click the Cancel button from
the login screen (accessible by clicking “Chg User” if in CFR mode).
Requirements for Operating in Digital Signature CFR Mode
CFR mode requires that you are processing validated T-700C or T-700E tags. In CFR mode, you are
subject to the authority of a system administrator. The system administrator has access to a small
program that interacts with Session Manager DB to manage changes in users and their status. The
system administrator will provide you with your initial user name, and can also control your access to
the software and require you to reset your password (the administrator does not have access to your
password setting). An automatic function of the system will force a password change every three
months.
Any non-CFR tag that is presented for reading or start/configure operations will require the
user to revert to non-CFR mode by clicking “Chg User” then clicking “Cancel” in the login
screen 2 . CFR mode can be re-entered by clicking on the Login button at the top of the
screen and logging in again.
2
Downloading of data from non-validated tags via the TagMate QC® handheld reader is described much later in these
instructions, but one aspect is related to this CFR discussion. Because of batch downloading requirements, Session
Manager DB will not force a change to non-CFR mode even when in CFR mode and downloading data from a non-CFR tag.
6
IR Mode Display (Reader Not Found)
At startup, lack of a Control Panel display indicates a failure to connect to an RFID reader, either the
DR-1 or other supported devices. In the same part of the screen where the Control Panel would be
displayed, the IR screen will appear. Although IR mode cannot be used for processing T-700 tags, it is
possible to receive T-700 data indirectly, via a TurboTag® TagMate QC® or TagMate USB® handheld
reader (see the section entitled “TagMate® Data Capture” below) and/or to access data files (see
below for more information about creation, viewing and printing of data files).
7
Reading Actions
At startup, when a reader is found, the Control Panel message area will indicate READ readiness by the
appearance below (a green indicator light and the title READ):
This toggle switch is in
the “Read” position.
The bold READ word is
displayed to the right.
You can click on this
switch to toggle back
and forth between
‘Start’ and ‘Read’.
This is the Control Panel
indicator light. A green
light indicates that the
Reader and Software are
ready to read a tag.
The message area
indicates that a tag can
now be presented to
the DR-1 for reading.
You must see this appearance of the Control Panel to begin to read T-700 tags. The green light will be
“on” and the message box area will indicate that the reader function is activated. Non-readiness
messages may appear if there is incomplete Event Log Data (see Database Event Log below).
Pick up one of your supplied T-700 tags and place it on the reader, as shown below. As you read
tags, you will notice the Graph Panel on the Session Manager DB screen. Data points from the
information recorded on the tag being read are presented in graphic format as a time vs. temperature
plot.
The tag is read (indicated by the green light Æ red light Æ green light transition on both the Control
Panel and the reader itself); a computer “beep” and a ”beep” from the DR-1 accompanies this
transition. The data is displayed on the Graph Panel in the Session Manager DB screen as shown
above. Summary data from the tag appears on the screen 3 and the data is immediately written to the
database, also data files if set to do so (see below).
Note:
Do not leave the tag resting on the DR-1 reader. The RF signal can cause an artificial
temperature rise. If the tag is left on the reader for too long, it may skip scheduled readings.
3
See section below entitled Alarms, Shelf Life and Data Summaries.
8
When no longer logging data with a tag, you can prolong battery life by making sure the tag is stopped
at the time of reading. To do this, check the box for “Stop tag after reading” in the READ Control Panel
(see below), and then read the tag.
•
Be sure to un-check this box whenever you do not intend to stop a tag in progress. Once tags
have been stopped, they cannot be re-started without erasure of their logged data.
•
When reading a full tag (702 data points), the software will always stop the tag. 4
Creating Data Files
In addition to the automatic database record, you may save data in files. To do this, check the “Save
next tag in…” box in the READ screen Control Panel, prior to reading a T-700 tag. A destination folder
After clicking the check box for file
creation, this button becomes
“live”. Clicking here enables you to
specify where you want to store
individual tag files.
Click on this check box
to activate file
creation.
The file format
incorporates the Info field,
Alarm status, TagID and
date read information –
creates *.txt and *.ttd
files.
Clicking here will cause the
program to stop tag recording
immediately after reading (See
Appendix A about Restart)
Click here to display remaining shelf
life as a function of time (instead of
temperature) See Appendix A
can be selected or created via the Browse button. Two file types are created automatically in the
destination directory after reading a tag:
•
•
A proprietary file format
(*.ttd file name). This file
type is for re-display and
printing within the
Session Manager DB
Software via the LOAD
button (or the File =>
Load menu command),
followed by the PRINT
button (or the File =>
Print menu command) if
desired.
The first field in the file name is the information contained in the
Info field…this was filled in during tag configuration and starting. In
this instance, the Info field contained “Freds Flowers 3”
A generic text file format
(*.txt file name). This file
type is for import into
other applications, or
viewing/printing via a
text-processing application. 5
TagID
Date and Time
The next four digits refer to alarm status types: Maximum,
Minimum, Tstd, and Shelf life…in that order. A “1” indicates an
active alarm; a “0” indicates no alarm. This “1010” code indicates
a Maximum and Tstd alarm for this particular tag data set.
File names are formatted to display key identifying information about the tag and information about the
recording session. Each file name is—in effect—a brief summary of the tag data itself.
4
See section on Continuous Mode for an exception to this rule, and an alternate way to process tags.
Although text files are editable, it is possible to verify that these files were not altered using a special viewer which
performs a checksum verification. The viewer application is accessed via the Start Menu(´All Programs´TurboTag). Also
in this location is an Excel template for importing text files automatically into a spreadsheet.
5
9
Opening Data Files from Windows® Explorer
The two file types described above can each be opened directly from Windows® Explorer by doubleclicking. The text file type (*.txt) opens with a text editor program such as Notepad. The proprietary file
type (*.ttd) must be opened in Session Manager (DB). The first time that this is attempted, you will get
this screen, in which you must choose the option indicated (Select the program from a list) and click
OK:
The next screen will list the programs that are available on the programs menu. Notice that both
Session Manager and Session Manager DB will appear on the list. Highlight the version of Session
Manager that you wish to open
file with, and click the OK button.
The next time that a “ttd” file is
double clicked, the file will open
up automatically in the software
type chosen.
When a file is opened in this
manner, the software bypasses
normal startup processes (login
and/or searching for RFID
reader) and enters IR Mode.
This double-click method only
works for opening a single file. It
is also possible to open “ttd” files
from within the software, in
READ mode or IR mode. This
process is described further
below, and can be used to open
multiple files.
10
Card Reading Errors
If Session Manager DB is in READ mode, and a T-700 tag is not successfully read, the following will
appear in the control panel:
Remove tag from reader and click
on the OK button to reset Session
Manager to READ mode, ready to
try again.
Card reading errors may be caused by removal of the T-700 before reading is finished. The red light
indicates active reading, so do not remove the card when the light is on. If repeated trials (sequentially
placing, reading until green light, and then removing the tag) do not result in a successful read, then
the card may be damaged or faulty, or incompatible with the software. 6
The Tag Status Panel
Data on ID parameters and T-700 status are presented in the Tag Status panel at each READ event:
The Timer On light will show
green if a tag is logging or is
in logging delay (see
discussion below). Low
Battery will show red if
battery voltage is too low for
continued operation
(approximately 1.35V)
The Full light will show
green if all 702 data points
were used in a tag that has
been read.
The Tag ID and Session ID are not user-editable, and are explained in the section entitled “ID Code
Inputs for Identification of Monitored Products”.
Reading a tag that is running will activate the Timer On light. A battery voltage will also be displayed in
the Tag Status panel (this value may not display if the tag is not running). Tag Status also shows
battery voltage in the START mode (see below).
If a tag battery has run down, 7 the Low Battery indicator will light up in the Tag Status screen when
processing tags for configuration and starting. If battery voltage is too low, it will not be possible to restart the tag. The Low Battery condition will not cause loss of data already stored on a tag.
Note that for tags that are read at the very beginning of a recording session, there is a minimum
number of three recorded data points before graphic display and file creation to be activated.
6
If the error message indicates a “Read Protect” feature, the tag was configured in a special way to limit its readability to
certain users. See Appendix G for details on the “Read Protect” function.
7
Under normal operating conditions, battery life is typically about 6 months of monitoring time, provided that it is used
within one year of the purchase of the tag.
11
Switching Between READ and START Modes
With the software running and a DR-1 reader connected, you will be in either the READ mode as
shown in the right image below, or the START mode as shown in the left image. To toggle between
these modes, click the toggle switch shown (or use the Operate Æ Start/Read menu commands).
Tag Read-Stop and Read-Stop-Restart
The Control Panel for READ mode provides several
options that are controlled by the checkboxes
shown below. The “Save…” and “Stop…” options
were discussed already. If both the “Stop…” and
“Save…” options are active, the “Restart” option is
available.
The selection(s) made are reflected in the toggle switch label, as shown below:
Stop or Restart
will appear here.
Stop if only the “Stop tag after reading”
box is checked, Restart if all three boxes
are checked.
In READ – RESTART mode (all three option boxes checked) the tag is read, and after a brief
pause accompanied by the message “Switching to reastrt mode…” the toggle is automatically
switched, accompanied by a label change to “RESTART”. While RESTART mode is active, the
tag on the reader (either the same tag, or a new tag if desired) will be configured and started
based on the settings retrieved from the just-read tag. After the RESTART is complete, or more
than five seconds have elapsed with no tag available, the screen will automatically return to
READ-RESTART mode. The data that had been read at the outset (displayed briefly before
switching to RESTART mode, then cleared in the RESTART screen) is returned to the READRESTART screen at the end of the sequence. This retrieval is effected by automatically
opening the most recently saved data file.
In RESTART mode, the initial shelf life setting from the just-read tag has an effect on the
configuration mode that is used:
•
Initial Shelf Life equal to zero: All configuration parameters are used as read from the
tag. (simple restart)
•
Initial Shelf Life not equal to zero: All configuration parameters except for log delay
and initial shelf life are unchanged. Log delay is forced to zero, and initial shelf life is
revised to equal the remaining shelf life. (shelf life carry-over)
Appendix A explains in detail the shelf life carry-over aspect of READ-RESTART operations.
12
TagMate® Handhelds for Reading Tags
An alternative for reading (stopping, restarting) tags while away from a
suitably-enabled computer is to use a TurboTag® TagMate QC® or TagMate
USB® Handheld Reader.
In brief:
•
Most of the displayed alarms and settings in the Session Manager DB
READ screen are offered via an LCD display on the TagMate QC®.
The TagMate USB® gives a red or green LED flash to indicate alarm
status. Both types or reader will give an extra long beep if an alarm
condition exists.
•
The TagMate QC® (only) can be used to create a graphic strip chart
printout using the TurboTag® MP-1 Printer accessory, also sold separately.
•
The TagMate QC® can store up to 99 tag data sets for later printing or
importing into Session Manager DB. The TagMate USB® can store
125-500 tag data sets, depending on file size, before saving them onto
a USB drive. Data capacity is effectively limitless with the USB drive
plugged in.
Information about importing data from TagMate® readers into Session Manager
DB is given later in these instructions (see TagMate® Data Capture, below).
Complete instructions for these devices are found in a separate document.
13
Alarms, Shelf Life and Data Summaries
In addition to the graphical summary, an array of numeric information about the READ event is
displayed on the Session Manager DB screen. This information appears in the Temperature Panel,
and the Time Panel, described below.
Temperature Panel
The Temperature Panel appears in the middle of the Session Manager DB screen. Temperature
summary data are given in this panel. This includes a report of time over a maximum specified
temperature limit (Tmax), time-under a minimum specified limit (Tmin) and an alarm limit specified
based on a standard temperature (Tstd).
Selector switches for
setting display units of
measurement. Click to
change from °FÆ°C or
from average
temperature to a
geometrically weighted
mean of temperature
(MKT, see Appendix B).
Kinetic parameter for Shelf
Life estimation and/or MKT
calculation.
Tmax overshoot is a singlereading alarm setting (degrees
above Tmax)
Tmax is the threshold
setting for out of-range
high temperatures.
Alarm inidicators for Tstd,
Hours Above, or Hours Below
compared with settings
displayed in blue (Hours
Above/Below settings are in
the Time Panel).
Tstd is an upper limit
alarm setting, compared
with either the MKT or
average temperature
from the tag.
Tmin is the threshold setting
for out-of-range low
temperatures.
Line colors serve as a key for
the graph, which displays each
setting as a reference line.
Maximum is the highest
temperature measured by
the tag.
Average/MKT is the
calculated mean of all
temperatures measured by
the tag.
Minimum is the lowest
temperature measured by
the tag.
Above and to the left is the
alarm indicator for the
maximum temperature
reading (vs. Tmax + Tmax
Overshoot)
A selector switch on this panel allows the user to display either °F or °C. Another selector switch shifts
the average temperature calculation from a simple arithmetic mean (Average) to a geometrically
weighted mean, MKT, which is commonly used in pharmaceutical applications (see Appendix B).
Time Panel
Summary information about time is displayed in the Time Panel (see figure on next page). The Time
Panel shows many additional configuration parameters in the blue-shaded boxes (Log Interval, Log
Delay, Hours Above and Hours Below alarm settings, and Initial Shelf Life) and information on Current
Shelf Life and Elapsed Time. See Appendix A for details on how to set up Shelf Life monitoring.
Information on time over Tmax and time under Tmin spans both the Temperature and Time Panels, as
shown below for Tmax. The alarm indicator is for “Hrs Above” exceeding the “Over Tmax” time limit.
Temperature Panel
Time Panel
14
The only alarm indicator in the Time Panel is the Available Shelf Life alarm. This is triggered by a
negative value in the “Current” column, as shown below.
The start time delay setting.
The date and time that
the tag began logging
(adjusted according to
the time zone settings of
the current computer).
The time interval
between temperature
readings.
Alarm settings for time-overtemperature and time-undertemperature are shown here.
If measured values are
greater, the Temperature
Panel will show alarm lights.
These boxes display
the value of the Initial
Shelf Life (see
Appendix A).
Current (i.e., Remaining) Shelf Life is
displayed in this area of the screen in a
running tag. If Shelf Life has expired, then
the Current Shelf Life as a negative number
and a red alarm light is displayed, as shown.
This area displays the
time elapsed since the
start time and date.
Even if a tag is
stopped, the Elapsed
Time is figured from the
Start time and date to
the Read time and
date.
When records are
viewed from the file,
elapsed time is always
calculated from the last
data point, not the real
time and date.
Current Shelf Life is replaced with this
message whenever the tag being read had
been previously stopped, and/or has reached
its data capacity.
The Shelf Life alarm is an optional alarm, and is activated by the Temperature Sensitivity (Ea) setting
in the Temperature Panel (see ablove). If this configuration setting is set to zero, the Available Shelf
Life value becomes the Logging Time Span, and the Shelf Life alarm is disabled, as shown below.
Note also that the Current Shelf Life display is not shown:
Further details about shelf life monitoring are given in Appendix A.
Graph Panel
Session Manager DB displays data read from a T-700 tag as a time-temperature graphic plot.
Horizontal colored lines on the Time -Temperature graph correspond to the preset temperature
parameters:
,
,and
. The display is auto-scaling in both X and Y directions. Manual editing
of the scaling (selecting X / Y axis numeric labels and editing them) is possible as well. The F/C toggle
switch
is used to control the units of temperature displayed on the graph.
15
View tabular
data listing
(see below)
For troubleshooting use
The graph panel will display a function of Shelf Life (expressed in remaining time) as a function of time
elapsed if the Control Panel option box for this type of display has been checked. The shelf life curve
is superimposed on the time-temperature plot. (see Appendix A for details on the use of Shelf Life).
Just above the graph panel on the right side the ACTIVITY LOG button allows access to a listing of
recent operations performed by Session Manager. This function is primarily for troubleshooting.
Data Viewing
A complete tabular listing of data displayed on the graph can be seen in a pop-up window by clicking
the VIEW DATA button just over the graph. The data units of the pop-up display always match those
of the graph. 8
8
The example screens here include optional shelf life values (see Appendix A).
16
Triple-clicking in the text box selects the entire dataset for copy-and-paste, as tabular text, into other
applications. The colored boxes to the right are explained in the next section.
Dataset Filtering
In some cases, a limited time range would be desired so as to remove irrelevant data before alarm and
summary data calculations. There are two ways to filter the data once it has been read form a tag.
One option is to clip the ends directly on the graph panel. End-clipping is performed by selecting and
editing the starting and/or ending time values on the x-axis of the graph panel as shown below.
The example screens below represent a data set before and after clipping at both ends.
17
Note that after end-clipping, there is a re-calculation of alarms and a new message box in the Time
panel. The RESTORE button in this message box will undo all clipping. While clipping is in effect, the
PRINT button can be used to generate a permanent record of the altered results.
A second alternative is to create a custom filter using the VIEW DATA screen. Custom filters are
completely flexible, allowing “hand-picking” of all data points that are to be displayed and included in
calculations. A custom filter cannot be created from an end-clipped dataset.
18
In the example graph above, a custom filter can be created so that no data points above 20°C will be
included. The filter is generated by scrolling thought the dataset in the VIEW DATA screen, clicking
alternately in the “start” (green) boxes and the “stop” (red) boxes according to the observed
temperature values (date-time values could be used as well). The “active” (blue) boxes show the data
points that will be included. Two of the representative selection points are shown below.
After all transitions above and below 20°C have been marked with start/stop markers, the OK button is
clicked to return to the main screen, and the result is as shown below:
19
This dataset now gives a graph and summary data with no value above 20°C. Note the new message
box and RESTORE button, as with the end-clipping method. A filter can also be removed from the
VIEW DATA screen by clicking the small “reset” button (only visible when a filter exists—see screen
examples above).
While filtering is in effect, the PRINT button can be used to generate a permanent record of the altered
results. The PRINT function is described in the section entitled “General Software Actions” below.
20
Database Event Log Configuration and Data Entry
Session Manager DB enables database storage of complete records of tag processing events (START
and/or READ). In addition to the time-temperature monitoring data and configuration and ID
parameters written to or read from the tag, additional user-controlled information can be stored in the
database, independent of the tag. This data is called Event Log Data. Users can take advantage of
the power of database retrieval tools (searching, sorting, etc.) by associating Event Log Data with tag
processing events. See Appendix E for a summary of query options that access Event Log Data and
other stored values.
Event Log Data Fields
In all operational modes, Session Manager DB displays several data entry boxes on the screen in the
Database Event Log panel just below the time-temperature graph:
During any process, these fields can be filled in with information using the keyboard. Just click in the
box and type in the data. Note that there are five fixed fields (including comments) and four userdefinable fields (labeled Usr1 thru Usr4 above). User-definable fields can be specifically set to have
field labels that are pertinent to the user’s own needs. To set the names of these fields and to control
other options related to data entry, click on the Configure button. The following pop-up screen will be
displayed:
This screen can be used to configure any field except Comments. Configuration options include field
names for user-defined fields, default values, and rules for data entry (Active/Required/Locked).
21
Status settings are interdependent. For example, a field cannot be Locked unless it has a default
value entered into the Default Value box (Locked fields are “grayed out” on the main software screen,
but the default values are visible). The Active setting determines if the field is visible on the main
software screen. The Required setting changes the data entry box to blue, and halts tag processing
until a value is entered. Note that no field can be simultaneously Locked and Required. During
processing of tags, all Event Log Data fields are restored to their default values after the data is written
to the database. 9
Event Log Data configurations are saved as special files, and will be recalled automatically in
connection with the operating mode of the software. In READ mode, there is only one default
configuration. 10 When first entering READ mode, this default configuration is establshed, and can be
edited as needed (subject to user access limitations if in CFR mode) using the Configuration screen
shown above.
When entering START mode, there are an unlimited number of Event Log Data Configurations
possible. Recall of a specific configuration is triggered by a change in Protocol. 11 Creation of a link
between a Protocol and an Event Log Data Configuration is one of the options in the Configuration
screen shown above (see checkbox at bottom). Note that all editing done in this screen is only saved
if the OK button is clicked.
An additional window will appear when the OK button is clicked in the Event Log Data Configuration
screen. This new window is for optional setup of a bar code scanner mediated process to automate
data entries. See Appendix D for details of this process. If you do not intend to use this feature of
Session Manager DB, just click the OK button at the top of this second screen to return to the Session
Manager DB main screen. Note that keyboard input is always enabled even if scanner input is being
implemented.
Comments Field
The comments field allows a text information message to be included in
the database record for a specific tag. As with other Event Log Data
fields, Comments are stored in the database record associated with the
next tag processing event, and are not stored on the tag itself. The
Comments field is useful for associating a unique message that can be
recovered via a database query when the tag is read later (action item,
notation about special conditions, etc.).
If it is desired to append a comment or other event log entry AFTER a tag has been read (and the tag
is not available for re-reading), this may be done via the tag’s data file (*.ttd) if it was created. This file
may be loaded with the LOAD button, then a comment, or other Event Log Data, may be added to the
screen, and the entire record including the database event log can be sent to the database by clicking
the “=>DB “ button. This creation of a database record from a *.ttd file is a non-CFR process and is
described in the next section.
9
An exception to this rule occurs during IR data transfer operation (see below for details).
A different READ mode Event Log Data Configuration is saved for CFR and non-CFR modes.
11
Protocols are specific sets of alarm and shelf life parameters that may be associated with particular products or shipment
categories (see Protocols, below).
10
22
General Software Actions
Unlike most Windows® programs, Session Manager DB offers only the “minimize”
option—the “maximize” and “close” buttons are disabled. The “close” operation is
carried out with the QUIT button in the upper right of the software screen, so that
connected devices, such as the TurboTag® DR-1 will be closed down properly at the time of closure of
Session Manager DB.
LOAD and PRINT functions are also provided in the row of buttons with QUIT, as shown below.
Click this button to load a
specific file that has been
previously saved. Session
Manager DB will allow the user
to select files with the *.ttd file
extension by going to the
designated file location and
®
displaying all valid TurboTag
files stored in that location
Click this button to access
printing/data output options.
Click this button to shut
down the current session
of Session Manager DB.
You cannot shut down the
program with the
Windows® “X” command.
Clicking on the PRINT button brings up a window for selection of a specific data output option. This
window is shown in the examples below:
Printing options are shown at the left. When one of these options is active, a printer selection box
appears below. Selection of a printer will set that as the default printer. The file generation option,
shown at the right, brings up a folder selection box.
•
The “Print Screen” option causes a print action that will reproduce graphics and numeric data
on the main screen and insert a “date of printing” panel.
•
The “Print Text” option creates an output that is essentially equivalent to the printout from a text
file (see “Data Files” discussion above).
•
The “Create Data Files” option will operate essentially as if a tag had just been read with the
“Save next tag…” option selected (see “Data Files” discussion above).
23
When the PRINT button is used, all of the above options will make use of the data set that is currently
displayed. This means that any custom data clipping or filtering that is done will be carried over to the
output (see “Dataset Filtering” section above).
Clicking on the LOAD button allows the tag data from a specific file (file with the extension *.ttd) to be
displayed in the same fashion as a just-read tag. A small message text area opens just under the
main message screen in the Control Panel showing the file being displayed.
When a grouping of more than one *.ttd file is selected in the pop-up window, as shown in the example
below, the earliest file selected will be displayed upon clicking “Open”. The remaining files will be
displayed by clicking LOAD again.
The number of pending files for viewing is displayed just above the LOAD button:
When the file list has been exhausted, the file counter disappears. Clicking the
LOAD button again will cause the pop-up window for file selection to re-appear. To clear a set of
loaded files without viewing them, toggle to START mode and then back to READ mode. If a READ
process is performed, the pending file list will be cleared.
The LOAD function is not available in CFR mode. The database retrieval option (see below) provides
a CFR-compliant method for record retrieval.
24
The following additional buttons in the upper right of the screen are specific to database operations.
(Export to Database) The =>DB button adds the currently loaded file to the database. This is
useful for prior users of non-database versions of Session Manager to allow non-databased file
records to become part of the database information set.
When a group of files is being viewed via the LOAD function, clicking the “=>DB” button will serve both
to export the current file and to bring up the next file for viewing.
When the “=>DB” button is used, the export function will make use of the data set that is currently
displayed. This means that any custom data clipping or filtering that is done will be carried over to the
output (see “Dataset Filtering” section above).
(Retrieve from Database) The DB=> button activates the Data Viewer window that allows
selection and filtering of database records for viewing in the main window. 12 Operation of this function
is explained in detail in Appendix E.
12
Text-based exports from the database into another (non-CFR) database may be carried out as well. This operation will
normally require consultation with a TurboTag® representative for customization of an export data file.
25
Configuring and Starting Tags with TurboTag® Session Manager DB
The START screen is entered by clicking the toggle switch or selecting the Operate Æ Start/Configure
Tags Æ Start Only from the menu. The initial appearance of the START-ONLY screen is shown
below. This screen is one of three START screen options, the other two being the “configure” modes,
CONFIGURE-ONLY and CONFIGURE-START.
The START screen’s data areas display a subset of all the information present on the READ screen,
organized in the same fashion. Most of the information displayed is in blue-shaded fields, which
contain the user-defined settings that are transferred to a tag when it is configured. These blueshaded fields become editable upon selection of one of the two CONFIGURE modes.
Configuration settings are generally managed by saving and retrieving them as a group, called a
“Protocol”. There is one special predefined Protocol called “Open”, and a limitless number of possible
user-defined Protocols. Working with Protocols is described in a separate section.
CONFIGURE Screen Inputs (Protocol = Open)
In order to begin working with configuration settings, first select the
CONFIGURE & START mode via the Control Panel. In a new
installation, the Open Protocol will be active as shown in the Control
Panel. Open Protocol is an ideal starting point for getting to know the
operation of the CONFIGURE screens. This Protocol is the only one
that allows for on-screen updates of tag configuration parameters
followed directly by their transfer to a tag. User-defined Protocols will
26
behave differently, overriding any changes made on the screen when processing a tag. These are
described in a separate section below.
Time Panel Inputs
The Time Panel (upper right part of the Session Manager DB window) allows inputs that control the
time that a tag starts, how frequently it takes a temperature reading, aspects of shelf life monitoring
(see Appendix A) and settings that determine time-over-temperature and time-under-temperature
alarm limits associated with Tmax and Tmin (see Temperature Panel).
This button activates
a calculation window
that translates
calendar-based
inputs into Log Delay
and Log Interval
(see Appendix C)
These values determine start time
logging frequency. Maximum
duration is controlled by logging
frequency
This time display
will keep updating
until the tag is
started.
These alarm
settings refer to
the amount of time
“over or under”
limits. Note that
the range of values
is controlled by the
Log Interval.
Click to increase value in box
Click to decrease value in box
Values can be manually entered into the boxes either by clicking in the box and typing in the desired
value, or using the spinner icons on the left of each box as shown below:
Note that all possible values may not be accessible via use of the spinner icons alone. In some cases,
the values allowed by the input boxes will be partially determined by other settings. For example, the
time-over-Tmax and time-under-Tmin settings are scaled to the Log Interval, so that an even multiple
of from 0 to 255 log intervals is allowed.
Setting the Log Interval and Log Delay
The Log Interval (2 seconds to 8 hours) and Log Delay (0 to 504 hours) inputs determine the time
interval between successive readings, and the time of the first data point, respectively.
•
A rule of thumb is that each week of logging time span requires 15 minutes of Log Interval.
Thus, for a 14-day logging duration, use at least a 30-minute Log Interval.
•
The first data point will be logged at a time equal to the time at which the tag is started plus the
Log Delay plus one Log Interval.
•
The Logging Start Date/Time displayed on the Time Panel, and written onto the tag, refers to
the end of the Log Delay. This time may therefore be in the future. It is displayed in the local
time zone, but stored in time-zone-independent format on the tag.
If tags are being prepared for immediate use, the “Configure & Start” option should be selected in the
Control Panel radio buttons, and the Log Delay should be zero, or perhaps a small value to allow for
some pre-equilibration time before logging. Note that logging never starts until one Log Interval has
elapsed, even with Log Delay equal to zero.
27
If tags are being configured at a time long before monitoring should begin, one can process the tag(s),
according to one of the following options:
•
•
Pre-configure a set of tags using the “Configure Only” screen. These tags may be stored for
later use. When ready to start monitoring, select the “Start Only” option in the START Control
Panel and re-process the tag(s).
o
Note that when running in the “START Only” mode, all blue-shaded configuration
parameters in the START screen will be overwritten by the values already stored on the
(pre-configured) tag as it is processed.
o
You can start pre-configured tags away from a computer by using the TagMate QC®
Handheld.
Alternatively, if neither a suitably configured computer nor a TagMate QC® is available at the
location of the monitoring start, select the “Configure & Start” option in the START Control
Panel and follow these steps for implementation of a longer Log Delay:
(1) Define the (future) date/time when monitoring will need to begin and write this information
on the tag (or on a label or envelope associated with the tag).
(2) Adjust the Log Delay so that the Date/Time Started display equals the desired start
date/time. Appendix C describes use of the calendar feature for setting Log Delay and Log
Interval.
(3) Process the tag on the DR-1 so that the tag begins running in delay mode. Begin use of
the tag when the pre-defined start date/time has arrived.
Temperature Panel Inputs
The Temperature Panel allows setting of temperature range upper boundary (Tmax) and lower
boundary (Tmin), a secondary “overshoot” Tmax, and a standard temperature (Tstd). These settings,
combined with Time Panel settings described above, determine all of the alarms that may be activated
upon reading a tag.
Tmax Overshoot sets
the upper Tmax alarm
limit. Enter degrees
OVER Tmax. Here, the
value is set at
9.0 + 46.4 = 54.4°F
Enter limit values for
Tmax, Tmin and Tstd.
These are used to set
up the alarm functions.
Toggle switch controls
units used for Start
programming entries.
Use the Calc button to pull up the
pop-up screen function that
permits time-temperature
tolerance data to be entered for
purposes of calculating
temperature sensitivity. When
this function is completed, the
resultant Ea value is automatically
entered into the data box.
Tmax and Tmin work together with other parameters to set alarm conditions. With Tmax, both time
and temperature alarms are available. The time alarm is set via the Hours Over Tmax (Time Panel)
and the temperature alarm is set via the Tmax Overshoot parameter shown above. With Tmin, only
one alarm, for Hours Under Tmin (Time Panel) is available.
The Temperature Sensitivity (Ea) parameter is an optional parameter related to shelf life or MKT
calculation, and may be set to zero if these types of monitoring are not needed.
28
Note:
The Hours Over and Hours Under alarm settings will be coerced to integer multiples of the log
interval, between 0 and 255 log intervals. If a value equivalent to more than 255 log intervals is
entered, it will automatically reset to a 255 log interval duration. It is best to always set the log
interval value before setting the Hours Over/Under values.
Tstd is the expected average (“standard”) temperature, and as such serves as an upper limit alarm for
the measured average (or MKT, see Appendix B) for the monitoring episode. It is also used with the
shelf life monitoring function, along with the Temperature Sensitivity (Ea) parameter (see Appendix A).
Starting the Tag’s Logging Operation on the DR-1
Once all required user inputs are supplied to the software screen, one or more tags may be configured
and started based on these settings. As described in the section above on reading tags, the tag is
held on the DR-1 reader while the Control Panel indicator light changes from green to read, then back
to green at the end. If the start operation is successful, a beep sound is heard; if not, an error
message is visible in the Control Panel message box. A battery level display appears in the Tag
Status area as the tag is started, and a low battery reading will prevent the start process from
continuing, and will be accompanied by the alarm indicator in the Tag Status area.
TagMate® Handhelds for Configuring and Starting Tags
An alternative for configuring and starting tags while away from a suitablyenabled computer is to use the TurboTag® TagMate QC® or TagMate USB®
handheld.
•
All TagMates will perform the Start Only and the Configure & Start
processes, but not the Configure Only process.
•
All TagMates in Start Only mode will start a tag even if it has not been
re-configured, by preserving the current configuration and clearing the
data memory.
•
All TagMates store one set of configuration parameters at a time, and
these configuration parameters are entered from a specially-configured
T-700 tag (see Transferring Protocols to the TagMate® below).
•
All TagMates converts between READ and START modes by DIP switch
settings, or with the use of special “ToggleTag” accessory tags.
•
The TagMate QC® can carry out a Restart process when in READ mode.
•
The TagMate USB® may be given a custom configuration via the USB
drive (see Appendix D).
Full details about the TagMate QC® and TagMate USB® are available in
separate instructions.
29
Monitoring in Continuous Mode (non-CFR)
Continuous Mode is a special way of logging data with non-CFR T-700 tags, whereby a tag will keep
logging after reaching its capacity of 702 data points, up to a total duration of 5,000 log intervals. After
reaching the initial 702 data point capacity, the tag begins continually replacing the oldest data points
with the newest ones, creating a “circular buffer” for temperature readings. A tag is originally placed
into Continuous Mode from the CONFIGURE-START screen by checking the “Continuous Mode”
option box in the Control Panel, shown below. This option box is only active if the Open Protocol is
active.
Once this selection box is checked, almost all of the Time Panel and Temperature Panel settings are
replaced by a large message, shown below:
As can be seen, only the log interval setting remains visible for editing. The function of “configuration”
is accomplished via the READ screen as described below. Note also the stated importance of NOT
allowing a tag to exceed its maximum timespan of about 16,000 data points without a READ event,
when using Continuous Mode. For a log interval of 15 minutes, shown above, the maximum time span
is about 5.5 months. It may be useful to mark the READ deadline from the screen onto the tag or its
container.
Configuration in Continuous Mode (READ)
As is suggested by the very different screen appearance above, Continuous Mode goes far beyond an
extension of the timespan of logging. In effect, this mode of operation consolidates two steps down to
just one. Starting a tag in Conitunuous Mode is little more than periodic maintenance of a steady
supply of (possibly-relevant) data points, and can be done with no knowledge of what is being
monitored, or exactly when. In normal logging operations, the start time and the configuration settings
are a critical part of the tag’s stored data, so a CONFIGURE-START step is required for every
monitoring session, and all data points are relevant. In Continuous Mode, neither configuration
settings nor start time come from the tag—they are determined solely by the software during the READ
event.
30
The configuration parameters and Info field 13 for a tag in Continuous Mode (“CM tag”) are taken from
the CM Configuration, selected from a pre-defined list of what are called Protocols. Creation of
Protocols is described in the section “Configuring and Starting Tags” below. Once a Protocol exists, it
is activated by clicking the “CM Config” button shown below. This button is always visible on the
READ screen, just below the message box, but its relevance is limited to CM tag READ events.
The current Protocol
name is given to the
right of the CM Config
button.
After clicking the “CM Config” button, a Protocol selection screen appears:
The listing shows stored Protocols. Protocols can be selected by checking in one of the boxes at the
left. Once a Protocol is selected, its name and parameters are shown in the blue boxes at the bottom.
Clicking “OK”, or the <Enter> key, will close this window and transfer this protocol’s settings to the
READ screen blue boxes; the Protocol name will appear next to the “CM Config” button. A
susbequent READ event with a CM tag will apply these configuration settings. 14
The following are configuration-related aspects of the CM READ event that differ from a normal twostep (CONFIGURE-START, then READ) process:
13
The Info field is described in a section below on identifiers for monitoring sessions.
Reading a normal tag changes the displayed configuration values to what was read from the tag. Reading a CM tag will
re-establlish all of the CM Configuration settings. To preview the CM Configuration settings before reading a CM tag, click
the CM Config button, then the <Enter> key.
14
31
•
The CM Configuration settings are never actually written to a CM tag. They are transferred to
the data files and screen summary displays, as if they had been read from the tag.
•
The Log Interval from the CM Configuration is replaced with the log interval on the tag; the
Log Delay from the CM Configuration is also disregarded; a value of zero is always applied.
•
The Initial Shelf Life from the CM Configuration is used not only for shelf life calculation (see
Appendix A), but it is also used to define a maximum time span of data read from the tag,
working backwards from the most recent data. This limit may lead to less than 702 data points
being read (available data from earlier times being left unread). 15
•
An Info Field6 is automatically created from the Protocol name. The Info field is given a prefix
of “CM-” as an indicator for Continuous Mode, followed by the first 13 suitable characters in the
Protocol name.
•
Start Date/Time is determined by moving backwards an appropriate number of log intervals
from the present time, so this value changes with each READ event.
•
Session ID also changes with every READ event, reflecting the uniqueness of each such
event. 16
READ-STOP in Continuous Mode
CM tags rely on being constantly on, and never full (recall the warning in the CONFIG-START screen
example shown above). For this reason, Session Manager DB cannot read a CM tag that is stopped
or full (>16,000 logging events since starting). Arising from this fact, the READ-STOP process
behaves differently for CM tags. Immediately after reading and stopping, the tag is erased and restarted, still in Continuous Mode but with a fresh supply of data points. 17
This adaptation of READ-STOP makes CM a truly one-step monitoring process: there is only a need to
use a CONFIG-START event to initially place the tag into Continuous Mode, or to change the log
interval; thereafter, only READ-STOP need be used at the end of each monitoring session, taking care
to select the correct CM Configuration as described above, and not to let the total timespan of 16,000
logging events elapse between any two READ-STOP events.
Notes:
To restart a full or stopped CM tag, it is necessary to use the CONFIG-START process. This
option also allows one to update the log interval of a CM tag if so desired.
CFR tag types (T-700C and T-700E) cannot be placed into Continuous Mode by Session
Manager DB.
15
The maximum number of data points read will fluctuate between 700, 701, and 702 for a CM tag, due to the manner in
which data are stored on the tag, in groups of three data points. The starting point is always set at an even multiple of
three data points.
16
Normally, when two READ events occur without re-starting a tag, the more recent event exactly duplicates all of the
data points in the earlier event, both in terms of “time stamp” as well as temperature. In Continuous Mode, the time
stamp of a given temperature reading is assigned as an estimate, working backward from the present, with no certainty
about the precise timing of any of the logging events beyond one log interval’s duration. Thus, time stamps are not
expected to be exactly the same, but only approximately the same, from one READ event to the next.
17
The earlier section on READ processes using the “Restart” option (an automated multi-step process) may be confused
with this truly single-step process on CM tags. In fact, a CM tag will not trigger the two-step, automated RESTART
process, even if the “Restart” box is checked. The functioning of READ-STOP mode on a CM tag is the same whether or not
the “Restart” box is checked.
32
Alarms and Summary Data in Continuous Mode (Selective Analysis)
Imagine a CM READ event in practice, taking place upon receipt of a delivery of temperature-sensitive
goods. It is reasonable to assume that the type of goods are easily determined, and that a simple
method exists for selecting the correct CM Configuration in Session Manager DB, enabling the desired
alarm criteria to be applied. Another critical aspect of the READ, however, is how many data points to
retrieve from the tag counting backwards from the most recent one. What would be desired are only
those data points that arise from the monitoring timespan in question, and all of them.
While, in some cases, a precise knowledge of this monitoring time span might be possible, in general it
is not, and furthermore it would be difficult to create a Protocol to exactly specify every possible
timespan of interest (via the Initial Shelf Life as described above). Typically, therefore, one must
decide whether to err on the side of reading too much data (possible false alarms) or too little data
(possible missed alarms).
There are two general approaches to handling this dilemma, both of them encouraging users to err on
the side of reading too much data while avoiding false alarms.
1. Make sure the tags stay in an “alarm-free” temperature environment well prior to their
monitoring use, thereby ensuring that they will not give false alarms if extra preliminary data are
retrieved from the tag.
2. Make sure that tags stay outside the compliance range (Tmin thru Tmax) prior to their use.
The first approach is logical enough, but the second approach seems quite at odds with common
sense—as if to GUARANTEE a false alarm from any extra preliminary data! The reason that the
second approach is in fact a very useful one relies on a special “Selective Analysis” rule for CM tag
data, given below:
The Selective Analysis Rule for CM READ Events
Starting from the earliest data point and moving forward within the retrieved data set, the
software will ONLY begin analyzing for alarms and data summaries AFTER either:
•
ONE data point is found to be INSIDE the (Tmin - Tmax) range,
or
•
80 Percent of the total retrieved data set has been processed
Once started, the analysis continues unconditionally through all subsequent data points.
The READ screen below illustrates this Selective Analysis rule in practice:
33
Tmax
Crossing
Point
Analysis Range
In this example, a CM tag with a log interval of 0.03 minute (2 seconds) was used. Note that the Info
field is “CM-Refrig Test 2” as a result of a CM tag READ event with a CM Configuration Protocol name
of “Refrig Test 2”. Based on the initial shelf life setting, up to 20 minutes of data could be retrieved
from this tag, so 600 data points were retrieved (Tag Status panel).
Although all of these data points are shown on the graph (and saved in the files), analyses for
Average, Maximum, Minimum and Current Shelf Life plus associated alarms are suspended until the
first data point below 8 °C (Tmax setting), which occurs about 8.5 minutes into the data set. The
suspension of calculations can be seen clearly in the shelf life data (yellow curve). Note that there is
no decrease in shelf life prior to the indicated analysis range (this can be verified via the VIEW DATA
screen, as shown below). As a further result of Selective Analysis, the summary data show:
•
The Maximum Temperature value in the Temperature Panel is 22.6 °C, reflecting the small
peak near the end of the data set, disregarding slightly higher tempertaures associated with
the small peak at 5 minutes.
•
The Hrs Above reading is 0.05, consistent with the 3 minutes at the end of the data set,
over Tmax and inside the analysis range (and disregarding the first 8.5 minutes over Tmax
but outside the analysis range).
•
The Average value is 9.5 °C, consistent with the data set inside the indicated analysis
range.
Another way to see Selective Analysis at work is via the VIEW DATA screen, shown below with the
example data set, scrolled to the Tmax (8 °C) crossing point (red line):
34
Note that the shelf life values remain at 20.000 until the first data point without the “High” indicator
(data point # 257). Thereafter, all data points result in shelf life reduction, irrespective of the “Alarm”
indicator.
But why use this method rather than the more obvious option of staying inside the Tmin-Tmax range,
well before the start of monitoring? The main reason is that it serves to “mark” the start of monitoring
by virtue of the sharp temperature change with which it is associated. This creates a virtual START
event whose presence gives assurance that all necessary data were retrieved, allows greater accuracy
on calculations that involve all data points (shelf life, average temperature and MKT), and allows
determination of the actual time span of a given CM monitoring episode.
Note:
READ-STOP should be used with CM tags whenever they are being placed into a preconditioning environment outside the monitoring Tmin-Tmax range, to remove any prior
data from an uncontrolled environment which may affect the Selective Analysis process.
35
Protocols
As sets of configuration parameters are reused, users will migrate from “Ad Hoc” configuration of tags,
using Open Protocol as describe above, to file-based configuration with “Named” Protocols. A Named
Protocol is way to recall a set of configuration parameters reliably and quickly, at any time. The
Protocol creation function is accessible whenever in Configure Only or Configure & Start mode. Just
below the START toggle and message area, the following Protocol entry area appears:
The initial default Protocol is the Open Protocol. This pre-defined Protocol is the only one that can
have its associated configuration settings continually changed 18 or overridden by data entry on the
main screen, as described above in connection with CONFIGURE processes. Once a particular set of
configuration parameters has been identified as a candidate for future use, it can be saved as a
Named Protocol. When a Named Protocol is activated later on, editing of main-screen configuration
settings only enables the user to define a new Protocol (see below); all configuration settings will revert
to their stored values for the active Named Protocol when configuring tags.
Protocol management (select, create, delete, set default) is done via the pop-up screen shown below,
accessed by clicking the “Update” button next to the Protocol name on the main screen.
18
Any changes made to configuration settings while “Open” is the active protocol will be automatically saved to “Open”
during any Protocol setup process in which the “OK” button is clicked—even if a different Protocol is selected or created
during the setup process.
36
In the above example setup screen, the default protocol is “Open” and the selected Protocol is “My
Protocol”. The selection was made by clicking the checkbox at the left of the listing. A new protocol
named “Ship Test” is being created with the configuration settings from the main screen, which are
displayed under “Current Settings” (these cannot be edited here). The name “Ship Test” was typed in
the New Protocol Name box, which activated the “ADD Current Settings as New Protocol” button just
below. 19 If this button is clicked, “Ship Test” will be added to the listing displayed, in alphabetical
sequence; if “OK” is subsequently clicked, it will be stored for later use.
The selected Protocol is also subject to the on-screen operations shown below:
Button
Immediate Result
Lasting Result, if “OK” is Clicked
Activates the Default indicator for
the select Protocol in the listing.
The default Protocol is automatically loaded each time
Session Manager DB is started up.
Deletes the selected Protocol
from the listing, and makes
“Open” the new selected Protocol.
The deleted Protocol will no longer be available, and its
name can be re-used later if desired.
Clicking OK will activate the selected protocol and save any changes made.
Importing Protocols
The import function allows merging-in of a set of Named Protocols from another instance of Session
Manager DB. This involves making a copy of the file “protocols.tts” found in the folder
“C:\TurboTag\Cfg\” from the other Session Manager DB
instance. Importing is accomplished by clicking the “Import..”
button, then browsing to the new “protocols.tts” file and clicking
“Open”. The merged Protocol set is now visible in the setup
screen. Any identically-named protocols from the imported file
will be skipped; the current Protocol of that name will be kept.
Importing is a means to harmonize Protocols across multiple computers. Users can create a central
authority for Protocol distribution by this method.
Note:
This method WILL NOT WORK by simply distributing a “replacement version” of
protocols.tts to various users and having them save it into their “C:\TurboTag\Cfg\” folder,
replacing the current file. The appropriate method for replacement of all current protocols
in this fashion is to manually delete all but the “Open” Protocol via the setup screen (after
setting “Open” as the default), then use the Import process.
19
If a name is not unique, the button will remain disabled (greyed). There is not way to directly replace a Protocol with a
new one of the same name, other than to delete the original one first. Re-use of the same Protocol name for different
settings is not a recommended practice.
37
Transferring Protocols and Clock Settings to a TagMate®
The TagMate QC® and TagMate USB® are optional handheld devices that can configure, start, read
and stop tags—and print the results (QC model only). Complete instructions for this family of devices
are in a separate document. Session Manager DB plays a key role in setting the Protocol stored on
this device, and used for configuring tags. Session Manager DB also serves as a receiving base for
data from the device (see section entitled “TagMate® Data Capture” below).
The communication between Session Manager DB and TagMate®, for purposes of controlling tag
starting functions, is mediated by specially-configured T-700 tags. In the START screen control panel,
a checkbox can be found at the bottom, and is enabled whenever in Configure Only or Configure &
Start mode (and Protocol is not equal to “Open”):
As seen in the figures above, the function of the checkbox depends on the mode of operation:
•
In Configure Only mode, the checkbox will enable production of a TagMate® Configuration
Tag from the T-700. This tag can be used as a means to transfer its configuration settings to a
TagMate®. Because the tag is not running, it can be used indefinitely for this purpose. The Info
Field on a TagMate Configuration Tag is automatically populated with the first 16 alphanumeric
characters (or hyphens or spaces) of the Protocol name. This Info field will be transferred to
the TagMate® as part of the configuration settings to be written to the tag.
•
In Configure & Start mode, with no log delay, the checkbox will enable production of a
TagMate® Clock Setup Tag from the T-700. 20 This tag can be used to transfer its stored time
value (adjusted by the elapsed logging time) to the TagMate®. When the TagMate Clock Setup
Tag is full, it can no longer be used in this way and must be Configured & Started again.
After preparing a TagMate® Configuration or Clock Setup Tag, the checkbox in the software is unchecked automatically, so there is no risk that it will be left checked by accident. When a T-700 is
used for one of these purposes, it can be de-comissioned and used in normal fashion for logging data
at any time, simply by reconfiguring without the checkbox checked. If a TagMate® Configuration or
Clock Setup tag is processed further in Session Manager DB, it will behave exactly as if it were a
normal tag.
Notes:
To avoid confusion, TagMate Configuration Tags should always be clearly labeled as such.
Where more than one such tag is used, the labeling should include configuration details,
and/or protocol names, to ensure correct use.
20
In CFR mode, this option is replaced with a “Read Protect” option. This option is explained in Appendix G.
38
CFR Mode and Protocols
Creating and naming a protocol is a significant act in the processing of data and setting up tags for
recording. Accordingly, the user access controls that are in place when Session Manager DB is
operating in CFR mode extend to this software function. Protocols for use in CFR mode can only be
created while the software is in CFR mode. 21 Protocol creation is a logged event, so that there is an
auditable trail of accountability for the creation and naming of the protocol. Protocols cannot be
imported as described above while in CFR mode. Any imported protocols will be converted to nonCFR protocols regardless of their type when created. Protocols that are valid CFR protocols are listed
by Session Manager DB when it is operating in Non-CFR mode (see screen image on the previous
page), but not vice versa. The screen below shows a CFR version of the Protocol Setup screen. Only
CFR protocols are visible, and all CFR protocols are given an asterisk “*” prefix. Note that the “Open”
protocol is always visible, but it is not possible to have this protocol selected when configuring tags in
CFR mode.
TagMate® Limitations under CFR Compliance
All TagMates can perform a Read(Stop) or Start Only operation on a T-700 tag of any kind, including
CFR-compliant tags. 22 Any T-700 tag be used as a TagMate® Configuration Tag as well. However,
only the TagMate USB® can configure a CFR-compliant T-700 tag type, and only when it is in a special
configuration. Appendix F gives details about using Session Manager DB to enable and control CFR
operations and other customized configurations for the TagMate USB®.
21
For users that have not been granted permission by the system administrator, the “Update” button will be grayed and
disabled.
22
For a CFR tag, the Start Only operation require a pre-configred tag with no stored data.
39
ID Code Inputs for Identification of Monitored Products/Locations
In the Tag Status panel (below), there are two parameters that are assigned automatically by Session
Manager DB. These are called Tag ID and Session ID. Neither value can be edited by the user.
Session ID is automatically
assigned when a tag is
presented for configuration.
It is not user configurable.
The Tag ID is unique to
each T-700 tag and is not
user configurable. It will
appear in this box when a
tag is placed in
communication for start
and configure actions.
These identifying numbers and codes are essential for networking and distributing data. Each
monitored package, location, conveyance, pallet or container that TurboTag® is monitoring can be
separated and identified by these ID features. Each physical T-700 tag has a unique identity (Tag ID
as well as the serial number bar code on the tag 23 ). Each monitoring session also has unique identity,
(Session ID).
Finally, a link to the identity of monitored products can be established by a descriptive identifier (“Info”
value) entered by the user, or by capture of the 24-character EPC from a UHF tag used in conjunction
with T-700 tag, as described further below.
Without a UHF-RFID reader attached, Session Manager DB automatically displays the Info field as
shown below. The Info field accepts up to 16 characters of alphanumeric text, including space and
hyphen characters.
For automated EPC entry, it is possible to run Session Manager DB with a UHF-RFID reader
attached 24 and a companion UHF tag carrying the EPC code. The stored EPC code provides a means
to correlate shipment ID information with temperature history information in the T-700 tag for supply
chain applications. When a UHF reader is connected in START mode, the EPC becomes a required
data field for tag configuration, hence the blue shading of the input box shown below:
Whether this field contains either the EPC code or Info input, the value is stored in the tag memory and
is retrieved during READ operations. A type identifier is also stored on the tag to instruct the software
whether to display the retrieved value as an EPC or Info value in READ mode (i.e., the labeling of this
field is tag-controlled, and determined dynamically in READ mode).
23
The bar code on the tag label is associated with Tag ID at the time of manufacture (to enable product support). The bar
code serial number is not stored in the tag memory.
24
Currently the only UHF RFID reader supported is the MPR Multi-Protocol PCMCIA RFID Reader Card produced by WJ
Communications Inc.
40
Data Security Features of T-700 Tags and Files
The following two types of control mechanisms are used to prevent unauthorized re-configuration of
tags and enhance the security and validity of the data. Normally, these mechanisms are not visible to
end users, but their presence should be recognized nonetheless.
(1) Password Protection. All T-700 tags are protected by a proprietary TurboTag® internal
password that prevents any tampering with data. Data recorded on a T-700 tag during a
recording session is simply not subject to alteration by any method.
(2) Re-use Limitation. T-700 tags can be purchased as unlimited-use or limited-use tags. If
purchased as limited-use tags, the number of available uses is displayed when tags are
processed (in the Tag Status area next to Data Capacity). Single-use tags are automatically
protected from data erasure and re-starting.
In Session Manager DB, an additional layer of security is provided by access limitations to the
database records that contain data read from tags. These records are not subject to editing, and
cannot be modified by users. Each record that has been marked as a CFR event is associated with
digital signatures, which register the user who performed the data storage action. All records are
further protected against alteration by an embedded, proprietary checksum process.
Although the TurboTag® database is set up to be non-editable, subsequent operations performed to
export data from the TurboTag® database may be subject to alterations not under the control of the
TurboTag® system. It is the responsibility of IT administrators to ensure that subsequent handling of
database information is appropriately secure and protected.
The normal location for the TurboTag® database is in C:\Program Files\TurboTag\data\.
Contact your sales representative or IT manager if you wish to have Session Manager DB
operating across multiple workstations with a shared database on a network drive, or if you
wish to export data records to another database.
Procedures for database maintenance (e.g., archival or restoration from a backup) are
accessible via the User Manager software utility, and are described in a separate document
associated with that software.
Tag data sets can be stored in proprietary files with the file extension *.ttd. TurboTag® files (*.ttd) are
encrypted and tamper-resistant. These are the only type of files that can be opened for data viewing in
Session Manager DB. These files can be put into the database in non-CFR mode only, using the
=>DB function (see description in General Software Actions).
Tag data sets can also be stored in text files (*.txt). Although text files are editable, it is possible to
verify that these files were not altered using a special viewer (TurboTagViewer.exe) which performs a
checksum verification. The viewer application is accessed via the Start Menu(´All
Programs´TurboTag). Also in this location is an Excel spreadsheet template (TurboTag Graph.xlt) for
importing text files automatically into spreadsheet format. Note that saved *.txt files cannot be loaded
into Session Manager DB.
The image above shows typical file listings in the C:\TurboTag directory. The naming protocol creates
file names that contain the Info field, an alarm summary, Tag ID and date/time stamp, as discussed in
more detail in the section on reading tags. Note that *.ttd files and *.txt files are in pairs. If file saving
has been selected, both file types will be generated on each READ event.
41
TagMate® Data Capture
The TagMate QC® and TagMate USB® handheld readers are both capable of transferring data to
Session Manager DB in a way that simulates a tag READ process on the DR-1. The TagMate QC®
relies on a special operating mode for Session Manager DB called IR mode, and an infrared port. The
TagMate USB® requires only that a USB drive be available to mediate file transfers, and this can be
accomplished with Session Manager in either IR mode or READ mode. These processes are
described below.
TagMate QC® Data Capture
The IR screen is obtained whenever a suitable RFID reader is not available on the computer for
discovery by the Session Manager DB. The appearance of the screen is the same as the READ
screen, except that the upper left Control Panel appears as shown below.
It is possible to enter this mode of operation by starting Session Manager DB after disconnecting the
DR-1 reader.
The upper left Control Panel area in IR mode contains information that pertains to managing the
descriptive information (“Startup Screen”) stored in the TagMate QC®, displayed during startup. and
transferred back with data files. The “Stop tag after reading” and “Restart” check boxes are missing
since direct communication with T-700 tags is not enabled.
The IR screen is useful for viewing / printing data that has previously been retrieved from a T-700 tag.
There are three options for this:
42
1. Use of the LOAD button to view previously-saved files (same as on READ screen).
2. Linking to the TagMate QC® Reader (purchased separately) via an IR port, which triggers
downloading of all stored tag data, sequentially displayed on the screen and saved
automatically. Full instructions on use of the TagMate QC® appear in a separate document.
3. Importing data files from a TagMate USB® via the USB drive (described below).
For data retrieval from the TagMate QC® Handheld Reader, an active
infrared port is required.
•
Most laptop computers have built-in infrared ports. If an
infrared port is not already present, or if an additional infrared
port is desired, any USB IrDA adapter can be installed.
When downloading tag data from the TagMate QC®, the message
area of the Control Panel will indicated the loading of files. All of the transferred data sets are saved
as data files.
As mentioned previously, you can use the “Update Handheld…” option to set a custom Startup
Screen. This feature is useful for identifying the user for HACCP and other regulated programs.
During any IR data exchange, the Time Zone/DST setting on the computer is transferred to the
TagMate QC® and the temperaure units (C or F) selection on the TagMate QC® is transferred to
Session Manager DB Software.
Notes:
The IR beam from the TagMate QC® reader must be aimed directly (on a straight and parallel
path) at the “window” of the BAFO® device. Hold the alignment steady during the process as
an uninterrupted stream of data must be received by the device for the transfer from the
TagMate QC® to the software to be completed.
TagMate USB® Data Capture
File transfers from TagMate USB® to Session Manager DB are mediated by a USB drive. The
TagMate USB® will automatically save all stored tag data to the drive whenever the drive is plugged
into the USB port on the reader. Data files will automatically be imported into Session Manager DB
when the USB drive is plugged into a USB port on the computer—after starting Session Manager DB.
Incoming files are seen in transient fashion, accompanied by a status message in the control panel.
All incoming data sets are saved as data files.
After importation, it is possible to review the datasets one at a time, by repeatedly clicking the LOAD
button. A caption over the button shows how many files remain to be viewed. After all files have been
viewed in this way, the caption disappears and the LOAD button will bring up the usual file selection
dialog. To clear the pending file list, toggle the screen back and forth between START mode and
READ mode.
USB file exchange can be a two-way process, with configuration information flowing back from
Session Manager DB to the TagMate USB®. Details about the process for configuring TagMate USB®
are given in Appendix F.
43
Appendix A - Shelf Life Monitoring Option
In addition to conventional upper/lower temperature limit settings available as Tmax and Tmin in the
START screen (plus average temperature or mean kinetic temperature as Tstd or MKT) that are
available with other data loggers, the T-700 tag uniquely supports an option to directly monitor
remaining shelf life according to widely-used Arrhenius kinetics.
Setting Up Shelf Life Monitoring
If you intend to monitor shelf life using TurboTag®, information on the time-temperature response of
your perishable product must be pre-programmed into a tag when it is configured prior to starting. If
you already know the parameters you will use, go to the next heading and follow the instructions for
configuring time and temperature parameters. If you have information about the time-temperature
characteristics of your product, you can use Session Manager to determine the values to use.
Let’s use a simple hypothetical example to illustrate how this works. From our own experience, let’s
assume that we know that our product has the following responses:
10
Shelf Life = 5 Days
Temp (°C)
4
Shelf Life = 14 Days
0
10
20
Time (Days)
Information on the shelf life of a given perishable product can first be independently determined at two
or more fixed temperatures that lie within the upper/lower limit boundaries for maximum and minimum
temperatures, and then translated into tag configuration parameters for configuring TurboTag® to
measure shelf life. Configuration in the START screen is performed by entering the appropriate time
and temperature values.
Shelf Life Configuration: Temperature Panel of START Screen
Taking one of the test temperatures as the standard temperature, this value is entered as Tstd.
We are assuming that this
hypothetical product
cannot tolerate 8° for any
appreciable length of time,
so we enter “8” as the
Tmax.
Here we are using the 2°C
temperature from the
hypothetical example.
When “2” is typed into the
Tstd box, it will be
displayed at “2.0”.
We are assuming for this hypothetical product that it
cannot tolerate freezing, so we enter “0” as the Tmin.
44
Next to the Temperature Sensitivity (Ea) entry cell, click the CALC button to bring up a calculation
utility that will determine the Ea value from the complete set of measured shelf life vs. temperature
data. The calculated Ea parameter is automatically written on the START screen, and this value may
be noted and re-entered directly whenever this type of product is monitored again.
When the
button is clicked, a pop-up screen (the Temperature Sensitivity Calculator) will appear.
Here is where the time-temperature data for the product will be entered, then click “Calculate”.
If you entered more than two sets of time and temperature tolerance values (as shown in the example
above) the value for Ea that is calculated is the “best fit” value for those entries. You can check the
closeness of the fit by clicking on the Graph button, which displays the linear best fit plot for the
function:
45
When you have finished in this window, the Save button will return the calculated Ea value to the
appropriate box on the START screen. Note that an Ea setting of zero is used to DISABLE shelf life
calculations altogether.
This completes all of the data entry that is required on the Temperature Panel of the START screen.
Shelf Life Configuration: Time Panel of START Screen
Completing the configuration of tags for shelf life monitoring requires definition of the existing shelf life
duration in the Time Panel of the START screen:
Enter the TIME value that corresponds to
the Tstd TEMPERATURE value entered
elsewhere on the START screen. In other
words, this value is the known shelf life
duration at the Tstd temperature.
With the appropriate time and temperature setup parameters entered, TurboTag® will monitor shelf life
when started.
Reading Shelf Life Data from Tags
Three outputs are provided in the READ screen for shelf life monitoring:
•
The Available Shelf Life…Initial display, which echoes the userdefined input value at the time of starting the tag. This display
appears on the Time Panel of the READ screen and repeats the
original entered pre-programmed input (see image at right).
•
The Available Shelf Life…Current display, which appears alongside
the initial value and the elapsed time. Note that a tag that has been
stopped or is full will not yield a shelf life value here,
because of the incompleteness of the logged
temperature data
o
•
If the Available Shelf Life…Current value falls
below zero, the associated alarm indicator will
light up, as in illustration on the far right.
A graph of Shelf Life vs. Time, accessible by checking
the “Display shelf life vs. time” box in the READ Control Panel. By checking and un-checking
this box, the graph will be displayed on the same graph panel as the time vs. temperature data.
The dual view illustrates with great clarity the shelf life loss associated with a particular
temperature pattern. This graphic shelf life output is available even with tags that are full or
stopped. Tabular values of shelf life vs. time can be viewed by clicking VIEW DATA.
Note:
Shelf Life updating does NOT begin until after the start delay. Make adjustments for the extra
time when assessing the total time-temperature contributions to remaining shelf life.
46
Restart with Shelf Life Carry-Over
Note that the READ mode of the software permits two distinct options in the checkbox region just
below the message box. If the “Stop tag after reading” and “Save next tag in…” boxes are checked,
another checkbox is activated. This additional checkbox is the Restart function.
When this option is selected, the tag is read and stopped and the record is saved to data files.
Session Manager will automatically restart the same tag (or a replacement tag if desired, and
one is readily available). The tag receives a new Session ID as for any new START event, but it
retains most or all of the configuration settings from the prior READ event. The initial shelf life
setting from the prior READ event has an effect on the RESTART result, as follows:
•
Simple RESTART—Initial Shelf Life equal to zero: All configuration parameters are
re-used. (simple restart)
•
RESTART with shelf life carry-over—Initial Shelf Life not equal to zero: All
configuration parameters except for log delay and initial shelf life are re-used. Log delay
is forced to zero, and initial shelf life is revised to equal the current shelf life from the
READ event.
In the latter mode (which also relies on tags that are not full and were logging just before
reading), RESTART allows a renewal of the data capacity on a tag, maintaining a running shelf
life calculation through the next logging cycle. Here is an example of how this works:
Read- Restart
Final Read
47
Appendix B – Using MKT with TurboTag®
MKT is a parameter used in the pharmaceutical industry in the US. MKT, or Mean Kinetic
Temperature is defined in the context of Controlled Room Temperature, which is a condition required
for a comprehensive list of drugs and preparations. From the USP literature, Controlled Room
Temperature is defined:
“A temperature maintained thermostatically that encompasses the usual and
customary working environment of 20°C to 25°C (68° to 77° F); that results in a
mean kinetic temperature calculated to be not more than 25°; and that allows for
excursions between 15° and 30° (59° and 86° F), that are experienced in
pharmacies, hospitals, and warehouses.”
These storage locations and the transport of CRT pharmaceuticals between locations are
required to maintain MKT at 25°C or less. Many CRT pharmaceuticals have a specified
shelf life of 1 year at CRT, which requires measurement of MKT for assessing the conformity
to this requirement. Many refrigerated preparations have a maximum exposure to
temperatures at CRT, as well.
Calculation from manual readings can be complicated. MKT is usually higher than the
arithmetic mean temperature and is derived from the Arrhenius equation. MKT addresses
temperature fluctuations during the storage period of the product. MKT is calculated by the
following equation:
in which DH is the heat of activation, which equals 83.144kJ per mole 25 ; R45 is the
universal gas constant, which equals 8.3144×10–3kJ per degree per mole; T1 is the average
temperature (°K) during the first time period,(e.g., the first week); T2 is the average
temperature (°K) during the second time period,(e.g., second week); and Tn is the average
during the nth time period,(e.g.,nth week) ,n being the total number of temperatures
recorded.
Making this calculation on a routine basis from temperature averages, of course, is not
practical. TurboTag® automates the MKT monitoring process.
TurboTag® is easy to set up for these types of applications. In a facility, TurboTag® can
monitor facility MKT for CRT compliance. Here are some general guidelines for setup:
(1) Set up for at least 12 measurements in daily period
(log interval of 2 hours) in the START screen.
(2) Pre-configure Tstd to 25.0°C in the START screen
(prior to recording).
(3) Set Ea to 20 in the START screen.
(4) When operating in the READ screen, set the
selector switch to MKT.
25
This corresponds to an Ea of 20 Kcals/mole. This value needs to be entered for MKT calculations to be performed
according to regulatory expectation.
48
Every time that you read TurboTag® in your pharmaceutical storage or shipping
environment, the current cumulative measured MKT will be displayed.
The displayed MKT value should be less than 25°C-MKT to conform to CRT maintenance
guidelines.
The same procedure may be followed for CCT criteria: set the MKT alarm for 8°C-MKT.
This value must
show at the preconfigured 25°C
value.
In this example, MKT is
less than 25°C, so there is
no alarm. If it shows
above 25°C-MKT, the
alarm light will show red.
Corrective action must be
taken to lower MKT to the
approved value.
The displayed value should be less than this to conform to new CCT maintenance
guidelines.
It may be also useful to set the maximum and minimum alarms to conform to the “not to
exceed” temperatures specified for CRT or CCT.
49
Appendix C – Setting Log Interval and Log Delay by the Calendar
When in START mode (configure and start option ONLY, AND ONLY with the Open
Protocol selected), the area of th e scre en next to the Log Delay setting shows a small
button,
which will bring up the window shown below, for calculating Log Interval and
Log Delay based on calendar inputs.
Enter the day and hour of the desired start time followed by the day and hour for completion
of the logging. Values for the minutes in each entry are calculated based on the Log Delay
and Log Interval and the current time. They are displayed, but users cannot edit them. The
Log Delay and Log Interval are automatically entered into the corresponding fields on the
main screen when the Save button is clicked.
Note:
If more than 30 minutes have elapsed after this calculation is performed, and before
processing the tag(s), it should be redone before processing any tags in order to
ensure a reasonable level of accuracy for the Log Delay value.
50
Appendix D – Use of a Bar Code Scanner for the Database Event Log
Database Log Event information is intended to provide ancillary non-tag data that is stored
in the database along with tag data. Database Event Log data can include important
shipping information, information about batch ID for traceability of products, and any other
type of information. These fields are intended for any information that has meaning in
combination with a time-temperature data set created by a T-700 tag.
Users of Session Manager DB can take advantage of a special feature of the software that
permits data entry automation using a barcode scanner. There are two types of barcode
scanners typically used in connection with a PC computer:
(1) A keyboard wedge scanner (connected in parallel with the keyboard; input
indistinguishable from keyboard input)
(2) A COM port connected scanner (connected to serial port or USB port)
Database Event Log data can be manually typed into the data entry boxes in Session
Manager DB. Since a keyboard wedge is the functional equivalent of the keyboard, data
may also be scanned into the same data entry boxes in sequence.
Further automation of this step can be achieved using the Scanner Input Settings window.
This window is reached by first clicking on the Configure button in the Database Event Log
area:
As you can see, the first four fields of the Database Event Log area are pre-set. The field
names are common to many shipping situations: Company Name of the shipping entity,
Location of the shipping point, Product being shipped and Shipment identification. This
information set is a basic characterization of a shipping instance to be monitored by
TurboTag®. In addition, there are 4 user-defined fields. These can be renamed by the user
based on specific requirements.
To illustrate this function using automation by bar code scanner programming, we can start
by setting up the configuration. We will set up the fields in the first configuration window.
We will start with a hypothetical example:
Field
Default
Required / Locked
Company
ABQ BioChem Ltd.
Locked
Location
none
Required (scan)
Product
none
Required (scan)
Shipment
none
Required (scan)
Usr1 (Rename to “Receiver”)
none
Required (scan)
Usr2 (Rename to “Carrier”)
none
Required (scan)
51
This table specifies how we want data to appear in the Event Log. We want to have scan
cards set up to automate data entry for packing and shipping personnel. Here is how to set
this up.
First we call up the first configuration screen and fill in the required information:
Note that we have set up all 6 fields that we intend to use, and have named two custom
fields per our requirements. We are also associating this configuration profile with a
parameter protocol called “New APR”. This means that when we select the protocol “New
APR”, this Event Data Configuration will automatically be loaded.
We can now proceed to screen where we can set up automated scanning of data into the
five fields that require scanner input. We will use the following specific example of a set of
information for a typical instance of data input:
Field
Specific Input
Location
HACKENSACK
PLANT
Product
BIOPACK 3
Bar Code
52
Shipment
BP23955A
Receiver
MILFORD
DIST.
Carrier
RAPID
REEFER
Click on the OK button on the Event Data Configuration screen.
Notice that only the fields that are active and not locked are displayed on this Scanner Input
Settings screen:
53
To determine if the fields will scan correctly, press the test button, and then scan. For
example if the Location barcode is scanned in test mode, the following display appears:
Both green lights are on: the first light signals a successful configuration of the COM port,
and the second light signals a successful scan. Note that the scanner is on COM port 6.
The test scan indicated that our scanner is adding a suffix: \r\n (carriage return-line feed). In
order for these codes to be stripped from entry into the database, we enter them into the
suffix box; this instructs Session Manager DB to ignore these codes when writing the
contents of a field into the database. They are “stripped” from data entry. The goal is to
have a test scan for each scan Field Name that returns only the desired input NOT including
the prefix and suffix data. Scan each field, then enter the suffix and prefix codes to make
sure they are stripped.
We can make up a scan card with the 5 bar codes on it, and these can be used to scan in
the appropriate information. Scanning in order results in this data entry completion:
54
When you begin scanning, Session Manager DB will start filling in the scan-enabled fields
as scan data arrives.
Getting the right data in the right field can be done by various methods.
Referring back to the scanner input settings, several are provided for the purpose of filtering
(prefix, suffix, min length, max length, numeric only). When these filtering criteria are set as
narrowly as possible, they can be made unique to each field. Unique field filtering thus can
act as a de facto priority assignment. Automating data entry in this way makes it impossible
for an operator to get any scan out of sequence or in the wrong field.
Another way to ensure that specific codes are entered into the proper data fields is to
construct a prefix that is unique to each field, and incorporate that prefix in the barcode
itself. Session Manager DB will recognize and strip these from data entry, but will
automatically recognize which field the information needs to go into. Different barcode
symbologies and scanner automation are factors to consider when using this method. It is
good practice to use at least one priority-setting prefix character that does NOT occur in the
body of the scanned data.
55
Appendix E – Data Retrieval, Viewing, and Printing from Database Records
Session Manager DB is distinguished by its capability to write all data read from a tag into a
single database record. This information is combined with user data (Event Log Data) to
form a powerful database-driven information system for cold chain monitoring.
Data read from tags can be optionally saved as file data (see above in this document), but
every tag read by Session Manager DB is automatically processed by entering all of the
tag’s data complement into the database in a single data record.
Sophisticated database users will have the capacity to merge data from the Session
ManagerDB database into larger data platforms such as SAP and Oracle.
Information can be easily obtained from database records within the operating environment
of Session Manager DB using the Data Viewer. To enter the Data Viewer, click on the
“Database Out” button
:
The Data Viewer screen shown below is the standard query interface for the database. In
this screen, records can be filtered based on any field used in Event Data Log, date ranges
for starting and reading, Info Field information, custom user-specified fields in the Event Log
category, and any time-temperature related parameter (Tmax, Tmin, Shelf Life, etc.).
User determined fields can be a very powerful feature for sorting records by shipment
information, customer name, product type, product batch number, or any of a fairly large set
of distinguishing information categories. Multiple filters allow record retrieval which can
highlight exceptions (time-temperature alarms) in combinations with user-specified fields.
When the filters are set, the Find button will perform the query and return the number of hits.
The View button will return these results for display on the main screen of Session Manager
DB, as shown below.
56
The above DB viewing screen looks much like the READ screen, but without the Database
Event Log fields at the bottom. In their place is a summary in a text box where the Control
Panel used to be. All Event Log Data, as well as event date stamp entries, show the history
of the tag record, which comprises one or more processing events. All of the relevant Time
and Temperature data for the most recent READ event appear on the screen as if that event
had just occurred. In contrast with the READ screen, however, the newly-named Timer On
Prev. indicator refers to the state of the tag before reading, not after.
Navigation through all of the retrieved records is performed by clicking through the list using
the button panel at the top of the information screen:
Closes
viewing
function
Reverses
selection
order
Selects next
record in
sequence
Selects last
record in
sequence
Note that the View Data button is active with any record involving temperature data
displayed on the graph (some records contain only Start event details and no temperature
data). This permits a quick scan of all numeric time-temperature(-shelf life) values. Shelf
life display on the graph as well as in the VIEW DATA summary depends on the previouslyestablished state of the “Display Shelf Life” checkbox from the READ screen. This option
cannot be changed once in the DB viewing screen.
57
Individual records can be printed in either of two modes. The PRINT SCREEN button in the
upper left of the screen provides a graphic one-page printout that includes the event log
data text box. 26 Selection of the printer for this function is done ahead of time via the
File=>Page Setup menu command. This process is analogous to the PRINT function from
the READ screen.
The PRINT TEXT button enables a text-based data summary to be sent directly to a printer.
Clicking this button brings up the following printer selection dialog, with the default printer
highlighted.
If “Adobe PDF” or another printer-based file creation process is an available option, then this
print function can generate a PDF file rather than a paper document. Files can be lengthy—
up to 28 pages for a full tag.
Either of these print options, if carried out in CFR mode, can generate a CFR-compliant
paper record of monitoring results.
Special Aspects of CFR Mode Usage
The Data Viewer screen has a different appearance if the DB=> button is pressed when you
are in CFR mode. Although the sort criteria controls are identical, the search is confined to
only those records that were generated in CFR mode with electronic signature in
combination with T-700C or T-700E tags.
:
26
The event log data is in a scrollable box; if information extends beyond the visible range, it will not print.
58
The CFR-only “View Audit Events” button brings up a screen that is for audit trail retrieval.
The term “Audit Events” refers to tag processing actions and other actions such as creating
new users in User Manager, working with protocols, passwords operations, etc. The user
must have role permission to access this feature (see documentation for User Manager
software).
All database records (tag data and audit data) are validated each time they are retrieved,
using an embedded checksum algorithm in order to verify that they were not tampered with
in any way. Checksum errors will be clearly displayed with data results if they occur.
59
Appendix F – Creating a Custom Operating Mode for TagMate USB®
The TagMate USB® handheld has a simple one-button / one-LED user interface, yet it has a
wide range of possible uses. The range of uses normally depends only on the reader’s
hardware configuration (barcode scanner and/or wireless modem option) and the settings
on the four DIP switches inside the device. DIP switches control the basic operating mode
(READ ONLY, READ-STOP, START ONLY, CONFIG-START), plus an option for creation of
data files from a START event, and (for suitably equipped models) an option for the
automatic transmission of new files over a wireless network.
Session Manager DB gives users the ability to create
custom configurations for TagMate USB® units, including a
CFR-compliance option. The custom configuration process
begins with the “TagMate USB” menu, shown at the right.
Operating Modes
The window shown below, accessed via the corresponding menu command, is used for
setting custom TagMate USB® Operating Modes.
The process is somewhat similar to managing Protocols as described in the main
instructions. An Operating Mode comprises a set of selections, shown in the circled area
above. Each Operating Mode is given a unique name before adding it to the list. Operating
Mode options are described fully in TagMate USB® instructions. Briefly, the three selections
across the top relate to aspects controlled by DIP switch settings, and the three selections
across the bottom relate to further options.
One noteworthy option from the lower list is the “Start After Read-Stop” setting. If “All” is
selected, then the reader will restart tags after reading them whenever it is in READ-STOP
60
mode. This option allows users to skip a step if their intention is to re-use a tag continually
rather than hold it for later use.
Near the top of the Operating Modes window is an entry box for “Company ID”. The
Company ID is appended to data files created by the TagMate USB®. Company ID is
generally only needed if files are being routed through an Internet portal by a hosting service
serving multiple companies; in that case the Company ID is assigned by the hosting service
and used to control the routing of data files. Company ID is analogous to a return address.
Whatever value is set for Company ID will be transferred to all TagMates that are
configured.
In CFR mode, the listing of Operating Modes will be limited to those that were created in
CFR mode. This is analogous to the Protocols
screen. Also, an additional parameter, the
expiration time for CFR configurations, can be
set. This parameter is explained below.
Device Listing
This window controls adding and removing specific TagMates from a list, which
activates(/inactivates) the generation of configuration files for these TagMates. TagMate
USB® entries are identified by using the 8-digit TagMate ID found on the barcode label on
the back of each unit. Each TagMate® is given a configuration via this screen. A
configuration includes a Description, an Operating Mode (see above) and, optionally, a
Protocol to be used for START-CONFIG mode. CFR operations are controlled by a CFR
Status parameter (diabled in figure). This is described later in connection with CFR
configuration operations.
61
When the window is opened, a “New TagMates Found” indicator may be visible (circled in
the example screen above). 27 Clicking the “Add to list” button will cause one or more new
entries to appear on the list. In the example screen below, resulting from clicking “Add to
list”, TagMate ID 40650017 was added, and given the default configuration.
Alternatively, a new TagMate ID (taken from the barcode label on the back of the reader)
can be manually entered in the blue-shaded “Existing TagMate ID” box at the top of the
screen. The caption will change to “New TagMate ID” and the “Update” button will change
to “Add” indicating that this TagMate ID is not yet on the list. The “Update(Add)” button is
only enabled when changes have been made in the blue-shaded boxes. The “Save” button
is only enabled after the “Update(Add)” button has been pressed.
When the “Save” button is clicked, the window closes and a set of configuration files for
each of the listed TagMates is created. These files are transferred to any USB drive that
arrives for file exchange on the PC. 28
The USB drive must be plugged in to
Tag Data
the PC after starting Session
Manager DB in order for file
exchange to occur.
Every time that a TagMate USB®
starts up with a USB drive plugged in,
it checks for a new configuration file,
and updates its configuration
accordingly. The presence of
configuration files for other TagMates
Configuration
TagMate
USB®
Session
Manager
27
Whenever a TagMate USB® starts up connected to a USB drive, it leaves a record of its TagMate ID on the USB drive.
The next time the USB drive is plugged into a PC with Session Manager DB running, this record is transferred to that PC,
allowing Session Manager DB to discover unlisted TagMates.
28
The USB drive must carry a record of having been connected to a particular TagMate USB in order to receive the
configuration file for that TagMate.
62
will not cause any confusion—each TagMate® uses only its own file. This configuration
process will occur repeatedly as new configurations are entered in Session Manager DB
and a USB drive is used for file exchange with the TagMate USB®. When a wireless modem
option is employed, this file exchange cycle can occur automatically, and with a global
reach.
CFR Configuration
The TagMate USB® Listing screen example above was for non-CFR mode. The following is
an example of a CFR-mode screen:
Whereas the non-CFR screen shows only TagMates with CFR Status = 0, and does not
allow editing of this parameter, the CFR screen shows all TagMates, some with nonzero
CFR Status. The CFR Status parameter may now be edited in some cases.
CFR Status values of 0 thru 2 are seen in the example. They indicate the following:
0 = Available for editing in non-CFR mode as well as CFR mode; cannot assign users.
1 = Available for editing only in CFR mode; can assign users (none currently assigned).
2 = Available for editing only in CFR mode; can assign users (one or more currently
assigned).
As can be seen in the example above (red circles), the selected TagMate USB® has a CFR
status of 2, meaning that there is already one or more assigned users. Note that this screen
does not allow editing of CFR status when it is 2. However, a new button has appeared for
editing users. The screen that is brought up by the button is shown below:
63
The screen above shows a listing of available users and assigned users for this TagMate
USB®. The assignment of users to a TagMate USB® can only be performed by Session
Manager DB users having a “User Administrator” role permission. 29
When a user is assigned to a TagMate USB®, this means that the TagMate USB® can
operate in CFR mode (i.e., it can configure CFR tags) whenever that user is “logged in”.
There are two ways for this login status to occur.
1) Single-user TagMate USB: automatic login on power-up.
2) Multi-user TagMate USB: login by scanning a TagMate User ID Tag that has been
assigned to the user (see next discussion).
Note in the example screen that one user has been assigned to the TagMate USB®, making
it a single-user device. Note also that the “Single User Only” indicator is not on. This means
that it is possible to assign another user. 30 The circumstance that causes a “Single User
Only” status to occur is the assignment ot a user that does not have a TagMate User ID tag
assigned, as discussed in the next section. The purpose of the TagMate User ID tag is to
inform a multi-user TagMate USB® which user is logged in at a given time, therefore it is
necessary (only) for the creation of a multi-user TagMate USB.
When a TagMate USB® is in CFR mode, an ID code for the logged in user is added to every
data file that is created. 31 This ID code is translated back to the Session Manager DB User
Name whenever the data file is received by Session Manager DB and stored in the
database. This leads to a CFR event, just as if the operation had been performed in CFR
mode at the computer, with that user logged in. By this means, the TagMate USB® has
served as an extension of a specific instance of Session Manager DB.
The creation of CFR mode on a TagMate USB® requires that the Session Manager DB
program responsible be given exclusive access to the subsequent confiruation of that
TagMate. This ownership relationship is enabled by use of secure access codes added to
the configuration files passed to the TagMate USB®. If another instance of Session
Manager DB creates a configuration file for that TagMate, the configuration file will be
29
Role permissions are discussed in the main instructions; they are managed in the companion User Manager software.
Had the Single User Only indicator been active, there would be no users shown in the Currently Available Users screen.
31
In CFR mode, data files will be created from both READ and START processes, regardless of DIP switch settings.
30
64
rejected. This security measure, plus the conveyance of one or more assigned users, is
what differentiates a CFR configuration file from a non-CFR configuration file.
The diagram below summarizes how (where) CFR Status is changed, and how it serves to
regulate the TagMate USB® configuration process.
Screen Used for Editing Actions
Edit Users Sub-Screen
TagMate Listing Screen
TagMate
CFR
Status
Not
Not
on
on List
List
Status
Status
== 00
Status
Status
== 11
non-CFR
Status
Status
== 22
CFR
Configuration File Type
As the diagram above shows, only a CFR Status of “2” will trigger the creation of a CFR
configuration file.
The TagMate® User ID list needs to be continually refreshed by new configuration files in
order to keep CFR mode active. A CFR mode expiration period is set via the TagMate USB
=> Operating Modes screen as shown above. If this period, beyond the time of
configuration file creation, is exceeded the TagMate USB® cannot be placed in CFR mode
until a newer CFR configuration file is received.
Session Manager DB automatically creates new configuration files on a daily basis when it
is running. Thus, regular USB file exchange and regular operation of Session Manager DB
will serve to ensure that a TagMate USB® CFR configuration never expires. Whenever all
users are unassigned for a given TagMate USB®, the CFR status reverts to 1 and the next
configuration file sent to the TagMate USB® will serve to take it out of CFR mdoe, at which
time any instance of Session Manager can configure it again.
65
TagMate® User IDs
The third item on the “TagMate USB” menu in Session Manager DB, called “User ID Tags”,
brings up the window shown below. This window is accessible only in CFR mode. It
supports the creation of special ID tags, called CFR Login Tags, that are used for user
identification on a CFR-configured TagMate USB®.
After selecting a user from the “User Name” pick list on the screen, an unused CFR Login
Tag is placed on the DR-1 reader to capture its ID. The CFR Login Tag looks like the
example below. It is a TurboTag® product.
TagMate™ CFR Login Tag
UserName (NON-TRANSFERABLE)
Sealed Air
TurboTag
For processing T-700 tags
in 21 CFR part 11 compliant
applications
RFID MONITORING SOLUTIONS
www.turbotag.com
When the ID tag is scanned, the DR-1 will beep, and the ID from the tag will appear in the
box on the screen, as shown below (circled). The example below shows the result of
scanning a CFR Login Tag with the selected user “BackupAdmin”. Note that the User Name
is now prefixed by an astersik (*) to show that it has an active CFR Login Tag assignment.
A different ID may be scanned at any time to replace that user’s CFR Login Tag
assignment. Only the currently-displayed ID is active for use with TagMate USB®, 32 but
prevously-used IDs can still be recognized by Session Manager DB.
32
The change in User ID takes effect once the change in UserID has been saved and the subsequently-generated
configuration file has been received at the affected TagMate USB(s).
66
When the “Save” button is clicked, a database record is created to associate the ID from the
tag with the user called “BackupAdmin”, and all configuration files are updated. As the onscreen instructions indicate, it is important to write the user name onto the CFR Login Tag
immediately.
The “Clear” button seen above next to the ID box will be disabled if a user is assigned to any
multi-user TagMates. The user would need to be un-assigned from these devices before
placing that user into the “No-CFR-Login-Tag” state with the “Clear” button.
When a CFR-configured TagMate USB® has a user list with more than one user, the CFR
Login Tag must be used for performing any CFR-mode operations on that device. If only
one user is identified in a CFR-configured TagMate USB®, the CFR Login Tag is not
needed: the unit will power-up with this user automatically logged in.
The purpose of enabling CFR mode and USB file exchange processes in the TagMate
USB® is twofold:
1. Simplify “satellite” operations requiring starting a CFR tag that is not pre-configured.
These operations no longer require a full Session Manager DB installation.
2. Minimize intra-company instances of Session Manager DB so that data records can
be kept together in one place, avoiding fragmentation of records.
Further details about CFR mode operation of TagMate USB® are found in the instructions for
that device.
67
Appendix G – “Read Protect” for Preventing Unauthorized READ Operations
Although normally configured T-700 tags of all types can be read by any TurboTag® system
(Session Manager (DB) or TagMate® Handhelds), there is a way for users to set up a limited
scope of readability, using CFR tags (T-700C or T-700E).
This Read Protect function is available when in CFR Config-Start mode (user is logged in).
The option checkbox shown below replaces the “TagMate™ Clock Setup Tag” option box in
that case:
non-CFR Mode
CFR Mode
When the “Read Protected” option is checked, the tag will be started in “Read Protect”
mode. Multiple tags may be palced in this mode without re-checking the option box. A tag
in Read Protect mode is given a “read access key” based on Session Manager DB’s current
Company ID setting . The Company ID is set as part of the TagMate USB® related
processes described in Appendix F.
In the screen shown below (accessed via the “TagMate USB => Operating Modes” menu command),
enter the Company ID in the circled box, then click on SAVE.
Note:
Once a Company ID has been used to place tags into Read Protect mode, the Company ID must
not be changed. If it is changed, these tags cannot be read any longer. It is always possibile to
restore the Company ID to its original value whenever necessary.
The “Read Protect” feature will also determine which Tagmate® handhelds are authorized to
read the tag. 33 If the TagMate® has the correct Company ID stored, it will be able to read
the tag; otherwise a reading error will result.
Only Session Manager DB software is capable of starting tags in Read Protect mode.
33
Earlier firmware versions of TagMate® Handhelds will treat ALL read-protected tags as Clock Setup tags. In this case,
they will not be able to read them, AND they will use them to update their internal clock setting as described earlier in
these insutructions.
68

Session Manager DB Software Instructions

Transcription

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