LogTag TIC20 User manual

LogTag
20 Day Transit Temperature Indicator
with display
DOCUMENT REVISION 1.3, 16 Apr 2013
© Copyright 2013, LogTag Recorders Limited
®

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 2 of 17
Contents
Contents..................................................................................................................................................2
Document revision history.......................................................................................................................2
Introduction..............................................................................................................................................3
Controls...................................................................................................................................................3
Display Overview ....................................................................................................................................4
Display elements during monitoring ....................................................................................................4
Display elements when reviewing statistics ........................................................................................5
Operation.................................................................................................................................................5
Starting the Indicator ...........................................................................................................................6
Monitoring Display Mode.....................................................................................................................7
Stopping the Indicator..........................................................................................................................8
Battery indication.................................................................................................................................9
Alarm settings .......................................................................................................................................10
Sample Alarm settings.......................................................................................................................10
Reviewing Statistic Data .......................................................................................................................11
Sample data set.................................................................................................................................11
Review walk-through.........................................................................................................................12
TIC20 Factory Pre-sets.........................................................................................................................16
Product Specifications...........................................................................................................................17
Document revision history
Ver
Date
Author
Details
0.1
CW
Initial TIC10 10day device
0.2
3/8/2011
MJ
Mod to TIC20, 20 day device. Updated LCD images and added the four WHO types
0.3
7/12/2011
MJ
Updated LCD images to include triggered ALARM temperature points during MONITORING
and STOPPED modes.
0.4
13/1/2012
MJ
Change entering Review mode to push and release within 1 second.
1.0
1/6/2012
MJ
Removed Type3 and Type4 Models, devices configured for 10 day only, 1st released
specification.
1.0
26/9/2012
17/10/12
MJ
MJ
Devices configured for 20days.
Change memory type in product Specifications, corrected product weight.
1.1
13/12/12
SL
Corrected various issues, general edit for readability. Added correct photos
1.2
27/12/12
SL
Small adjustments in terminology to align with TICT specification document. Moved
Specification to last page (same as TICT document).
1.3
16/04/13
SL
Created LogTag®specific version of document without WHO products, clarified temperature
specs

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 3 of 17
Introduction
The LogTag®TIC20 20 Day Transit Pharmaceutical Temperature Indicator has been designed for use
in applications where temperature & time statistics are monitored in pharmaceutical transports of up to
20 days duration.
The Indicator allows viewing key transit data on its built-in display, including statistics of readings that
meet or exceed pre-specified alarm limits. This allows a shipment pass/fail decision to be made
without the need for any other device such as a computer or printer. The display can be photocopied
if a record is required. The indicator can be downloaded if required via the free LogTag Analyzer
companion software and the TICT/TIC20 interface.
Two push buttons allow starting and stopping the Indicator and can also be used to navigate the
various display screens.
Controls
The TIC20 has two buttons, which allow starting and stopping the Indicator and can also be used to
navigate the various display screens.
START
STOP
Press and hold for 5 seconds to activate and START the
Indicator.
Press and hold for 6 seconds to STOP the Indicator.
Return to Stopped screen during review
REVIEW
Press and release within 1 second to view daily statistics.
(when Indicator is stopped)
Momentary press to advance the display to the next day’s
statistics.
While in READY or STOPPED mode the display will turn off to conserve power. Pressing either
button will cause the screen to activate and remain activated for a period of 30 seconds of no button
activity.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 4 of 17
Display Overview
None of the alarm summary or statistic display modes have any flashing elements, so the display can
be photocopied.
Display elements during monitoring
Elapsed Time
since start of monitoring
Current
Temperature
Monitored Load
Load OK
For a reject load
will appear, with additional
information about the
Alarms
Battery Condition
Battery OK
For Low battery
will appear
Recording Summary Area
This area contains to
markers.
The markers are only visible for
days on which alarms were
triggered.
covers the first 24 hours
of recording.
and one or more
temperature limit markers may
also be displayed.
STATUS:
READY
ready to be started
START DELAY
in delayed start
MONITORING
Reading & Storing
statistics

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 5 of 17
Display elements when reviewing statistics
Day’s temperature summary
For each 24 hour period the maximum
(MAX) or minimum (MIN) recorded
temperature is shown, if it exceeded
or fell below one of the pre-set alarm
limits.
Recording summary
This area contains to markers.
The ►arrow next to a marker indicates the
day for which the summary data are
displayed.
covers the first 24 hours of recording.
STATUS:
STOPPED
Finished recording
Only when the indictor has
been stopped can the
statistics be displayed.
Limit Markers
For each day, statistics for up to four
different temperature limits are
collected.
If an arrow ► is displayed next to ALM1 ,
ALM2 , ALM3 or ALM4 , an alarm occurred
at this level.
When reviewing, the arrow next to a
temperature limit marker indicates this
limit’s statistics are being displayed.
Day’s time summary
If the recorded temperature exceeded or
fell below one of the pre-set limits, the
DURATION indicates how long the
recorded values were above or below this
limit (represented by the highlighted limit
marker).
If this resulted in an Alarm being triggered,
the TRIGGER AT time indicates the hour
at which the temperature was first
recorded above or below this limit.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 6 of 17
Operation
Starting the Indicator
READY State
A short press of either button will activate the
display.
If READY is displayed, the Indicator can be started.
The Battery condition is also displayed as
- OK ( )
- Low( )
After 30 seconds the Indicator will re-enter a
hibernated state and the display will switch off.
To start the Indicator press and hold the START
button for 5 seconds.
The MONITORING indicator will flash.
When MONITORING is permanently lit, release the
START button within 2 seconds.
START DELAY State
The indicator has now started its 60 minute START
DELAY countdown. It should be immediately
placed in the load to be monitored so that the
temperature is stable and within specification once
the monitoring begins.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 7 of 17
Monitoring Display Mode
Monitoring Display - LOAD OK
In this example, the device has been
monitoring for 18 hours and is still active.
The symbol is shown as no alarms have
been triggered.
The last temperature reading is also displayed.
Monitoring Display - LOAD REJECT
In this example, the device has been
monitoring for 6 days and 1 hour and is still
active.
The symbol has been replaced by the
symbol, and since a >45°C ALARM has
occurred, the load should be rejected.
Markers for the days on which the temperature
has exceeded or fallen below the preset
temperature limits are shown. The screen
example shows that on , and
temperatures outside the preset acceptance
limits were recorded.
Both screens show ‘MONITORING’to indicate that temperatures are still being recorded and that the
unit is still active.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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Stopping the Indicator
You must take care when stopping the indicator, as it cannot be restarted once stopped.
Stopping Display –initiating stop
Press and hold the STOP button for 6 seconds.
The text adjacent to the MONITORING text will flash,
indicating a pending stop.
Stopping Display –pending stop waiting for release
When STOPPED is permanently lit, release the STOP
button within 2 seconds.
If you release the STOP button before the STOPPED text
becomes permanently lit, or you do not release the STOP
button inside 2 seconds after the STOPPED text is
permanently lit, the unit will not stop, and the state returns to
MONITORING.
Stopped Display –Monitoring is complete
The indicator has now stopped recording.
The trip duration was 6 days and 1 hour.
An ALARM occurred on , and .
The load should be rejected as indicated by the symbol.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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Battery indication
The battery condition can be OK or LOW, as shown in the display examples below.
An Indicator should not be used if it shows the low battery symbol at the beginning of a trip. Indicators
with a low battery not yet recording cannot be started.
Battery is Low
Battery is OK

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 10 of 17
Alarm settings
LogTag®TIC20 indicators are purchased with one of a number of different factory configuration
profiles pre-installed (see TIC20 Factory Pre-sets on page 16). The following pages are based on
these sample Alarm settings.
Alarm levels
Temperature alarm limit
Period of exposure
ALM1
<= -0.5°C single event
1 hour
ALM2
>= 30°C cumulative exposure
10 hours
ALM3
>= 45°C single event
1 hour
ALM4
Disabled
Example of an alarm display for above
alarm limits.
The symbol is displayed continuously if
any alarm was triggered during monitoring.
Temperature statistics for day 5 are
displayed (cursor ►next to ).
The temperature went below the <-0.5°C
limit (►next to ALM1 ), which also triggered
the ‘ALARM’. The duration of the alarm
and the trigger hour are also displayed.
Each day represents a period of 24 hours from 0:00:00 to 23:59:59. Day 1 begins when the start
delay has elapsed and the Indicator starts monitoring. A new day starts when the clock
advances from 23:59:59 to 0:00:00. On the display the ‘hours’will change from 23 to 0.
Readings and durations are always allocated against the day in which they occur. If a new day
starts during a period of exposure to temperatures outside the acceptable range, each day is
allocated the partial time of exposure. Both parts count towards a single event.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 11 of 17
Reviewing Statistic Data
Sample data set
An example data set is used to demonstrate an Indicator with the alarm settings as described above, where
monitoring was stopped on day 10.
For this example the processing on a day by day basis for ten days is as shown in the table below:-
Carried
over
Exposure
hrs
Total hrs
Alarm
Trigger-hr
To be
carried over
Statistic
Displayed
DAY 1
> 45 deg
0
0.5
0.5
no
n/a
0
Max 46°C, 30 min duration
> 30 deg
0
2
2
no
n/a
2
Max 46°C, 2 hrs duration
< 0.5deg
0
0
0
no
n/a
10
DAY 2
> 45 deg
0
0
0
no
n/a
0
> 30 deg
2
0
2
no
n/a
2
< 0.5deg
0
0
0
no
n/a
18
DAY 3
> 45 deg
0
0
0
no
n/a
0
> 30 deg
2
0
2
no
n/a
2
< 0.5deg
0
0
0
no
n/a
0
DAY 4
> 45 deg
0
0
0
no
n/a
0
> 30 deg
2
0
2
no
n/a
2
< 0.5deg
0
0.5
.5
no
n/a
0
Min -0.7°C, 30 min duration
DAY 5
> 45 deg
0
0
0
no
n/a
0
> 30 deg
2
0
2
no
n/a
2
< 0.5deg
0
4
4
yes
18
0
Min -2.0°C, 4 hrs, 18th hr trigger
DAY 6
> 45 deg
0
0
0
no
n/a
0
> 30 deg
2
0
2
no
n/a
2
< 0.5deg
0
0
0
no
n/a
0
DAY 7
> 45 deg
0
1
1
yes (1)
19
0
Max 48.5°C,6 hrs,19th hr trigger
> 30 deg
2
6
8
no
n/a
8
Max 48.5°C, 6 hrs duration
< 0.5deg
0
0
0
no
07
17
DAY 8
> 45 deg
0
0
0
no
n/a
0
> 30 deg
8
14
22
yes (2)
2 and 12
2
Max 36°C,14 hrs, 2nd hr trigger
< 0.5deg
0
0
0
no
n/a
0
DAY 9
> 45 deg
0
0
0
no
n/a
0
> 30 deg
2
4.5
6.5
no
n/a
6.5
Max 33°C, 4.5 hrs duration
< 0.5deg
0
0
0
no
n/a
5
DAY 10
> 45 deg
0
0
0
no
n/a
END
> 30 deg
2
0
2
no
n/a
END
< 0.5deg
0
0
0
no
n/a
END

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
© Copyright 2013, LogTag Recorders Limited page 12 of 17
Review walk-through
Day
Temperature conditions and alarm trigger status
Display
1
Press and release the REVIEW button.
The ►arrow will appear next to .
If temperatures exceeded or fell below any limit,
the statistics data and any alarm raised are now
displayed.
In this instance temperatures above 30°C
(indicated by the ►next to ALM2 ) were recorded
for 2 hours, with a maximum of 46.0°C. This did
not trigger an alarm, as the alarm trigger requires
cumulative exposure of 10 hours or more to
temperatures above 30°C.
Press and release the REVIEW button to
advance to the next screen.
On day 1 temperatures above 45°C were
recorded for a time of 30 Minutes, indicated by
the ►next to ALM2 . Again, this did not trigger an
alarm, as only constant exposure for one hour to
temperatures above 45°C triggers this alarm.
2
Press and release the REVIEW button to
advance to the next screen.
Since no further events were recorded for day 1,
the screen now shows data for day 2, indicated
by the arrow ►next to .
Temperatures remain below 30°C and
above -0.5°C during all of day 2, therefore no
statistics are being displayed, and no alarms
have yet been triggered.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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Day
Temperature conditions and alarm trigger status
Display
3
Press and release the REVIEW button to
advance to the next screen.
Since no further events were recorded for day 2,
the screen now shows data for day 3, indicated
by the arrow ►next to .
Temperatures remain below 30°C and
above -0.5°C during all of day 2, therefore no
statistics are being displayed, and no alarms
have been triggered.
4
Press and release the REVIEW button to
advance to the next screen.
Since no further events were recorded for day 3,
the screen now shows data for day 4, indicated
by the arrow ►next to .
Temperatures below -0.5°C were recorded for a
time of 30 Minutes, indicated by the ►next to
ALM1 . This did not trigger an alarm, as only
constant exposure for one hour to temperatures
lower than -0.5°C triggers this alarm.
5
Press and release the REVIEW button to
advance to the next screen.
Since no further events were recorded for day 4,
the screen now shows data for day 5, indicated
by the arrow ►next to .
Temperatures below -0.5°C were recorded for a
total time of 4 hours. This triggered the alarm
ALM1 , as constant exposure for more than one
hour to temperatures lower than -0.5°C was
recorded.
The first temperature reading below -0.5°C was
recorded after 17 hours on day 5, and after 18
hours on that day the alarm condition was met,
which is shown as the alarm trigger time.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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Day
Temperature conditions and alarm trigger status
Display
6
Press and release the REVIEW button to
advance to the next screen.
Since no further events were recorded for day 5,
the screen now shows data for day 6, indicated
by the arrow ►next to .
Temperatures remain below 30°C and above
0.5°C during all of day 2, therefore no statistics
are being displayed, and no alarms have been
triggered.
7
Press and release the REVIEW button.
Since no further events were recorded for day 6,
the screen now shows data for day 7, indicated
by the arrow ►next to .
In this instance temperatures above 30°C
(indicated by the ►next to ALM 2) were
recorded for 6 hours, with a maximum of 48.5°C.
This did not trigger an alarm, as the alarm trigger
requires cumulative exposure of 10 hours or
more to temperatures above 30°C.
Press and release the REVIEW button.
Temperatures above 45°C were recorded for a
time of 1 hour with a maximum reading of
48.5°C. This triggered a single event alarm at 19
hours, indicated by the ►next to ALM 3.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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Day
Temperature conditions and alarm trigger status
Display
8
Press and release the REVIEW button.
Since no further events were recorded for day 7,
the screen now shows data for day 8, indicated
by the arrow ►next to .
Temperatures above 30°C were recorded for 14
hours with a maximum temperature of 36.0°C.
The >30°C alarm trigger ALM 2 occurred at
hour 2, when the cumulative time for temperature
exposure above 30°C reached 10 hours.
A second >30°C alarm trigger occurs again at
hour 12, but only the 1st alarm statistic is shown.
9
Press and release the REVIEW button.
Since no further events were recorded for day 8,
the screen now shows data for day 9, indicated
by the arrow ►next to .
Temperatures above 30°C were recorded for 4.5
hours, with a maximum of 33.0°C. This did not
trigger an alarm.
10
Press and release the REVIEW button.
Since no further events were recorded for day 9,
the screen now shows data for day 10, indicated
by the arrow ►next to .
Temperatures remain below 30°C and
above -0.5°C during day 10, therefore no
statistics are being displayed, and no alarms
have been triggered.
The Indicator was stopped on Day10.
Pressing the REVIEW button again will display
the statistics for .
Pressing the START STOP button at any time
will show the STOPPED display

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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TIC20 Factory Pre-sets
LogTag®TIC20 indicators cannot be client configured, but instead are purchased with one of a
number of different factory configuration profiles pre-installed. If a default configuration does not suit,
customers can compile their own profile by specifying the parameters in the table below when
ordering. Please note that minimum order quantities apply for TIC20 units with profiles not stocked by
LogTag®.
The default configuration profile is called “Profile 0006”; each custom configuration is assigned a
different profile number which can be used for ordering.
Description
Profile 0006
(default)
Range / Option
Requirement
Maximum Days
(Maximum number of days to monitor)
20
1-20
Sampling interval
6 minutes*
1 to 15 minutes
Start Delay
60 minutes
0 to 99 minutes, 0=no delay
Display Temperature units
°C
°C or °F **
Hibernate once STOPPED
(Stops the Real Time Clock, increases length of period in
which the unit can be downloaded)
off
on or off
Allow stopping with STOP button
on
on or off
ALM 1
(Alarm
Limit 1)
Monitor this alarm
enabled
enabled or disabled
Temperature limit value
10°C
-30°C to 60°C (-22°F to 140°F)
Alarm activation
instant
instant, accumulated or consecutive***
Activation delay time****
N/A
1 minute to 45 days
Direction
upper
upper/lower
ALM 2
(Alarm
Limit 2)
Monitor this alarm
enabled
enabled or disabled
Temperature limit value
8°C
-30°C to 60°C (-22°F to 140°F)
Alarm activation
accumulated
instant, accumulated or consecutive***
Activation delay time****
12 hours
1 minute to 45 days
Direction
upper
upper/lower
ALM 3
(Alarm
Limit 3)
Monitor this alarm
enabled
enabled or disabled
Temperature limit value
2°C
-30°C to 60°C (-22°F to 140°F)
Alarm activation
accumulated
instant, accumulated or consecutive***
Activation delay time****
12 hours
1 minute to 45 days
Direction
lower
upper/lower
ALM 4
(Alarm
Limit 4)
Monitor this alarm
enabled
enabled or disabled
Temperature limit value
0°C
-30°C to 60°C (-22°F to 140°F)
Alarm activation
instant
instant, accumulated or consecutive***
Activation delay time****
N/A
1 minute to 45 days
Direction
lower
upper/lower
* 6 minutes = 0.1 hour; preferred intervals are 1, 2, 3, 6 and 12 minutes
** When °F is chosen, temperatures above 99°F will be shown on the display without a decimal point, but will be listed correctly in downloaded
data.
*** Instant = one temperature reading is above/below limit; consecutive = temperature readings are above/below limit for the time defined in the
activation delay time without interruption (single event); accumulative = temperature readings above/below limit for a total of time defined in
the Activation delay time, but may not necessarily be sequential.
**** Delay times for alarm activations must be in multiples of the sampling interval.

LogTag®- 20 Day Pharmaceutical Temperature Indicator with display
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Product Specifications
LogTag®Part Code
TIC20
Operating Temperature Range
-30°C to +60°C (-22°F to +140°F)
Ambient humidity range during transport
and use
0% to 95%RH
Resolution
0.1°C or better in range of -30°C to +60°C
0.2°F from -22°F to 99.8°F, 1°F from 100°F to +140°F
Accuracy
better than ±0.5°C for -10°C to +40°C (+14°F to +104°F)
better than ±1.0°C for -30°C to -10°C (-22°F to +14°F)
better than ±1.0°C for +40°C to +60°C (+104°F to +140°F)
Capacity
Minimum & maximum temperature for each of the 20 days.
1st activation of each alarm for each day including trigger time and duration of
each excursion.
Please note the TICT does not store each individual temperature reading taken.
Memory type
Non-volatile.
Sampling Interval
1-15minutes, factory set to 6 minute interval for profile 0006 (i.e. 0.1hour)
Recordings
20 day statistics, temperature/time excursions and alarm trigger time and
duration for each day.
Start delay
1-99 minutes, factory set to 60 minutes for profile 0006
Sensor
Precision electronic thermistor
Sensor Reaction time
T90 less than 7 minutes by method detailed in EN12830:1999
Vibration
Withstands vibration specification as detailed in EN12830:1999
Shock
Withstands shock specification as detailed in EN12830:1999
Withstand 5 drops 1m to smooth concrete floor without loss of function or
calibration.
Environmental
IEC 60529: IP64
Resistance to Electrical Storms
Designed to resist the effects of intense electrical storms.
Power source
3V Lithium battery –non replaceable
Battery life
Minimum storage life of 18 months before ‘start’.
Monitoring period: 20 days.
Minimum accessibility (display) period of 6 months after ‘stopped’
Size
73mm(H) x 54.5mm(W) x 8.6mm(T) (Volume < 34cm3)
Weight
30g.
Case Material
Polycarbonate.
Warranty
One year replaceable warranty against defects in materials and workmanship
from the date of purchase. Excludes misuse or abuse of the product or as a
result of unauthorized alteration or repairs.
Calibration
Certificate of Traceability and Calibration to ISO/IEC17025 available on request.
EMC compliance
EC EMC directives (EN 61000-6-1:2005 & EN 61000-6-3:2006)
Including electrostatic discharge as prescribed in EN 61000-4-2.
Complies with FCC Part 15 Subparts A and B.
Alarms function & display
Alarms are displayed on a custom LCD.
Display is static allowing photocopying.
This product is designed to meet or exceed the WHO PQS performance specification E06/TR07.x