Berlinger Q-tag CLm doc devices User Manual

berlinger Q-tag CLm doc devices are data loggers designed to monitor temperature profiles during transportation and storage. They are ideal for various applications like pharmaceutical products, vaccines, and other temperature-sensitive goods. These devices offer precise temperature monitoring, recording data, and generating reports to ensure compliance with regulations and maintain product integrity.

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User Manual Q-tag
CLm doc devices
3 — Last update: 20 December 2022
Table of Contents
1. Introduction ....................................................................................................................................... 4
1.1. Product Overview ....................................................................................................................... 5
1.2. Display explanations .................................................................................................................. 8
1.3. State of delivery / sleep mode .................................................................................................... 9
1.4. Gathering information prior to device activation (in sleep mode)............................................... 10
2. Start it .............................................................................................................................................. 13
2.1. Reading out CID / serial number .............................................................................................. 14
2.2. Activation of a Q-tag CLm doc family device ............................................................................ 15
3. Send it .............................................................................................................................................. 17
3.1. Start delay (optional) ................................................................................................................ 18
3.2. Error messages........................................................................................................................ 19
3.3. Temperature recording / Placing the device ............................................................................. 20
3.4. Add a marker ........................................................................................................................... 21
3.5. Display indication during temperature recording ....................................................................... 22
4. Stop it............................................................................................................................................... 23
4.1. End of temperature recording / STOP mode ............................................................................. 24
4.2. Reading the display after the device has been stopped ............................................................ 25
4.3. Gathering information after activation of the device or in STOP mode ...................................... 26
5. Read out........................................................................................................................................... 29
5.1. Connecting the device with a computer .................................................................................... 30
5.1.1. PDF file – sample of a PDF file generated by a Q-tag CLm doc L .................................... 31
5.1.2. Sample of an ASCII file generated by a Q-tag CLm doc L ................................................ 33
5.2. Remove device from USB port ................................................................................................. 35
6. Important Information ..................................................................................................................... 36
7. Q-tag CLm doc L User Guide Videos.............................................................................................. 38
8. Firmware .......................................................................................................................................... 39
9. FAQ / Glossary ................................................................................................................................ 40
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1. Introduction
Q-tag CLm doc family
The Q-tag CLm doc family monitors reliably and precisely preset temperature profiles. It indicates the
current date and time and provides a visual indication of ALARMS on the display. Details about ALARM
events may be obtained upon pressing the INFO-button and/or via a downloaded report achieved
through the USB connection with a computer.
Data control with Berlinger Verifier
The data of each CLm doc device can be verified with Berlinger Verifier.
Data management with Berlinger SmartView
Thanks to Berlinger SmartView, the collected temperature data from Qtag CLm doc devices can be analyzed easily and indepth for significant
workflow improvements!
Table of Contents
•
•
•
•
Product Overview
Display explanation
State of delivery / sleep mode
Gathering information prior to device activation:
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1.1. Product Overview
Q-tag CLm doc L
The durable one
To monitor your transport and storage
single-use data logger with 38,000 log points
Technical information
Device information
Q-tag CLm doc D
The cool one
To monitor your dry ice packages
single-use data logger with 38,000 log points
Technical information
Device information
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Q-tag CLm doc LR
The profitable one
To monitor your transport
reusable data logger with 38,000 log points
Technical information
Device information
Q-tag CLm doc
The clever one
To monitor your passive cold transport
single-use data logger
Technical information
Device information
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Q-tag CLm Ice
The frosty one
To monitor your frozen packages
single-use data logger with 38,000 log points
Technical information
Device information
Q-tag CLm Ice R
The restartable chilly one
To monitor your frozen packages
reusable data logger with 38,000 log points
Technical information
Device information
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1.2. Display explanations
The Q-tag CLm doc family monitors reliably and precisely preset temperature profiles. It indicates the
current date and time and provides a visual indication of ALARMS on the display. Details about ALARM
events may be obtained upon pressing the INFO-button and/or via a downloaded report achieved
through the USB connection with a computer.
1. OK (
2.
3.
4.
5.
6.
7.
8.
9.
) or ALARM (
) indicator
Individual ALARM indicators
Operating indicator (running indicator)
START indicator (device started)
TIME EXP: time expired indicator (allowed recording time exceeded, optional)
EXP OFF: device expired
OFF indicator (device stopped)
Duration display (DAY/h or h/MIN) and temperature display
Time display (duration and temperature display in sleep mode)
Date display (details of ALARM settings in sleep mode)
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1.3. State of delivery / sleep mode
Q-tag CLm doc devices will be shipped in the “sleep mode”.
In this mode the display is blank. This is the state of delivery of the device. The device is not activated,
and no data is recorded.
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1.4. Gathering information prior to device
activation (in sleep mode)
Diverse information can be read out after the INFO button has been pressed 3 times in one second.
After 1 minute the device goes back into sleep mode; the display is blank again. (The date format is dd/
mm/yyyy.)
1st
display:
all segments activated
2nd
display:
date and time of production test results
3rd
display:
start delay time
4th
display:
current date, time and ambient temperature
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5th
display:
temperature, time limits and ALARM type
S: single event
HI: high limit
Time: h 01 00 MIN
Explanation: Alarm occurs if the limit of 44.9&deg;C is exceeded for
1 hour continuously.
6th
display:
*
temperature, time limits and ALARM type
C: cumulative event
HI: high limit
Time: h 10 00 MIN
Explanation: Alarm occurs if the limit of 29.9&deg;C is exceeded 10
hours in total (sum of Hi Range violation).
7th
display:
*
temperature, time limits and ALARM type
S: single event
LO: low limit –0.4&deg;C
Time: h 01 00 MIN
Explanation: Alarm occurs if the limit of –0.4&deg;C is undercut by 1
hour continuously.
8th
display:
*
temperature, time limits and ALARM type
C: cumulative event
LO: low limit –0.4&deg;C
Time: h 01 40 MIN
Explanation: Alarm occurs if the limit of –1.4&deg;C is undercut by 1
h 40 min. (sum of LO range violation).
9th
display:
*
temperature, time limits and ALARM type
S: single event
HI: high limit
Time: h 00 01 MIN
Explanation: Alarm occurs if the limit of 8.9&deg;C exceeds 1
minute continuously.
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10th
display:
time expiry (max. running time in days)
Explanation: TIME EXP appears on the display after 20 days of
operation.
*(only indicated if factory-preset, otherwise skipped)
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2. Start it
Table of Contents
• Reading out CID/serial number
• Activation of a Q-tag CLm doc family device
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2.1. Reading out CID / serial number
Before activation press and hold the INFO button until the display starts up. The CID number
(cofiguration ID) is shown for 10 seconds, after that the serial number is displayed for 10 seconds. Then
the display goes back into sleep mode.
CID (Configuration Identification Number)
Serial number
After activation (start logging) both numbers cannot be read out through the device anymore. After
stopping, the CID and serial number can be read out through the PDF file with a computer.
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2.2. Activation of a Q-tag CLm doc family
device
Q-tag CLm doc devices can be started as follows:
Q-
To initiate a shipment, press and
hold the START/ STOP button
tag
until the display starts up.
CLm Active recording is shown by the
doc
L
(OK symbol) or
(ALARM
symbol) and the flashing dot on
the LCD.
Qtag
CLm
doc
D&amp;
CLm
doc
Ice
To initiate a shipment, press and
hold the START/ STOP button
until the display starts up.
Active recording is shown by the
(OK symbol) or
(ALARM
symbol) and the flashing dot on
the LCD.
To initiate a shipment, break the
Qrespective tab.
tag
Active recording is shown by the
CLm
(OK symbol) or
(ALARM
doc symbol) and the flashing dot on
the LCD.
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Option 1: To initiate a shipment,
press and hold the START/STOP
button until the display starts up.
Option 2: After reactivation with
Q-
the software easy go and
disconnecting the device from the
tag
USB interface
CLm Option 3: After preconfigured
doc
LR
autostart date and time
Important: Before reactivation of
&amp;
a Q-tag CLm doc LR or Q-tag
CLm CLm doc Ice R device you must
doc
Ice
connect the device to a USB port,
please read out the recorded
R
data, otherwise the recorded data
will be lost!
Active recording is shown by the
(OK symbol) or
(ALARM
symbol) and the flashing dot on
the LCD.
Expiry date: Please always verify the expiry date prior to using any device.
Expiry date explanation: Example exp 2020-01: In this example the expiry date of the device is January
2020 or 365 days after first use.
Q-tag easy go software
Reconfiguration and backup
The Q-tag easy go software is used to activate and reconfigure Q-tag CLm doc LR and Q-tag CLm doc
Ice R devices as well as to safeguard the collected data.
Contact us to get the software: [email protected]
More information: www.berlinger.com/easygo
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3. Send it
Table of Contents
• Start delay
• Error messages
• Temperature recording / Placing the device
• Add a marker
• Display indication during temperature recording
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3.1. Start delay (optional)
If a start delay has been preset, the device starts recording the temperature after the completion of the
start delay time. The start delay time is displayed by the flashing START and the remaining time of the
countdown.
Stopping the device during the start period is not possible.
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3.2. Error messages
An error message can only occur before or during the device activation. If an error message like in the
example occurs, do not use the device in any case!
(Possible error notifications: Err01-Err17)
Please contact the Berlinger support team immediately.
E-mail: [email protected]
For any other purposes please contact our sales team.
E-mail: [email protected], phone: +41 71 982 88 11
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3.3. Temperature recording / Placing the
device
The activated monitor must be placed immediately in its predetermined location. As described in the
SOP, or otherwise it is recommended to place the device as close to the supervised goods as possible.
This is an important prerequisite to ensure the temperatures observed by the device are as close to the
product temperature as possible.
Important: It is recommended to “precondition” the device to the desired mean temperature for about 30
minutes before use, especially if no start delay time has been programmed. This is to ensure against
false readings during start-up.
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3.4. Add a marker
In order to mark a special event like a start of a destination “A” or an arrival of a destination “B” with a
time stamp (M1, M2, etc.) on the PDF, press the INFO button 3 times in a row. When setting the first
marker “1” will be shown at the display for 3 seconds, after that the information disappears. For the next
marker “2” is shown on the screen and so on and so forth. Up to 255 markers can be set per run.
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3.5. Display indication during temperature
recording
A
(OK symbol) is indicated during
normal operation as long as no ALARM
have been recorded.
This
(OK symbol) will be replaced by
a
(ALARM symbol) as soon as any
ALARM has been triggered. (1 violation)
Additional arrows are shown in the left
display area to indicate which limit has
been violated. The operating indicator is
flashing. (3 violations)
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4. Stop it
Table of Contents
• End of temperature recording / STOP mode
• Reading the display after the device has been stopped
• Gathering information after activation of the device or in STOP mode
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4.1. End of temperature recording / STOP
mode
The device may be stopped if the
recording shall be finished, e.g. if a
shipment has reached its final
destination. To do so press and hold the
START/STOP button until OFF appears
on the buttom right corner of the display.
The dot will disappear.
For the Q-tag CLm doc only the plastic
USB cover has to be pushed down and
up in order to break off the STOP tab.
The display indicates “OFF” and the
flashing dot disappears.
Important: All other indicators such as
(OK symbol) or
(ALARM symbol) and individual ALARM
arrows remain stable for at least 3 months after recoding has been stopped.
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4.2. Reading the display after the device has
been stopped
OK display
The monitored goods have not been
exposed to temperature and time
conditions outside the preset ALARM
parameters.
ALARM display
The monitored goods have been
exposed to temperature and time
conditions outside the preset ALARM
parameters.
Important: The ALARM indication
cannot be cancelled nor reset.
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4.3. Gathering information after activation of
the device or in STOP mode
The information indicated on the LCD screen upon successive pressing of the INFO button after
activation or in STOP mode is explained below. (The date format is dd/mm/yyyy.)
1.
Current date, time and ambient temperature
2.
Temperature minimum with date and time of occurrence
3.
Temperature maximum with date and time of occurrence
4.*
Date, time and duration of 1st ALARM type
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5.**
Date, time and duration of 2nd occurrence of 1st ALARM (max. 3
single events)
6.**
Date, time and duration of 3rd occurrence of 1st ALARM
(max. 3 single events)
The information will be the same as from point 4. to 6. refering to your individual alarm settings.
7.*
Date, time and duration of 2nd ALARM
8.**
Date, time and duration of 2nd occurrence of 2nd ALARM (max. 3 single events)
9.**
Date, time and duration of 3rd occurrence of 2nd ALARM (max. 3 single events)
10.*
Date, time and duration of 3rd ALARM
11.** Date, time and duration of 2nd occurrence of 3rd ALARM (max. 3 single events)
12.** Date, time and duration of 3rd occurrence of 3rd ALARM (max. 3 single events)
13.*
Date, time and duration of 4th ALARM
14.** Date, time and duration of 2nd occurrence of 4th ALARM (max. 3 single events)
15.** Date, time and duration of 3rd occurrence of 4th ALARM (max. 3 single events)
16.*
Date, time and duration of 5th ALARM
17.** Date, time and duration of 2nd occurrence of 5th ALARM (max. 3 single events)
18.** Date, time and duration of 3rd occurrence of 5th ALARM (max. 3 single events)
19. Transport time
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20. Start date and time (device activation)
21. Off date and time (device activation)
*(only indicated if ALARM limit preset and range violations occurred, otherwise skipped)
**(only indicated if ALARM limit preset as single-event type and range violations occurred, otherwise
skipped)
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5. Read out
Table of Contents
• Connecting the device with a computer
• Remove device from USB port
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5.1. Connecting the device with a computer
Plug in the device into any computer via USB interface. Make sure the device is plugged in properly.
The following window will appear.
Wait sufficient time for the device to generate the ASCII and PDF files (approx. 10 seconds). Doubleclick the Q-tag CLm doc device (like any external file/drive). Save the PDF and text file on your computer
and open the PDF file to see a summary of data and graph or open the text file to view individual
temperature recordings (raw data).
Note: For this process no additional software is necessary.
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5.1.1. PDF file – sample of a PDF file
generated by a Q-tag CLm doc L
Page 1: Information overview
Page 2: Temperature graph
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Page 3: Marker information
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5.1.2. Sample of an ASCII file generated by a
Q-tag CLm doc L
Sample of an ASCII file
Data control with Berlinger Verifier
The data of each Q-tag CLm doc device can be verified with Berlinger Verifier.
Contact us to get the software: [email protected]
More information: www.berlinger.com/verifier
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5.2. Remove device from USB port
For a proper USB port disconnection of the device, please always use the “safely remove hardware”
function on your PC/Mac.
Do not disconnect the device before you receive the following message:
Hardware can be removed now. The device “CLM DOC (D:) can be removed from the computer now.”
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6. Important Information
Liability
The manufacturer shall not be held liable:
• if the device was used beyond the manufacturer’s given limitations.
• for any claims due to the improper storage and use of the device.
• for any problems with the temperature controlling and/or cooling unit.
• for the bad quality of any monitored goods.
• for incorrect readings if the device was used beyond its expiry date.
Battery
The devices of the Q-tag CLm doc family contain a lithium battery. Please pay strict attention to the
following points:
• The housing of a Q-tag CLm doc family device must never be opened nor destroyed.
• Do never expose a device of the Q-tag CLm doc family to temperatures above the allowed range
(fire, oven, microwaves, etc.). It may cause injuries.
• Always keep a device from the Q-tag CLm doc family out of the reach of children.
• The battery complies with IATA DGR Packaging Instruction 970 Section II and is therefore not
considered as dangerous good.
• Dispose or recycle the device from the Q-tag CLm doc family in accordance with the WEEE 2012/
19/EU guidelines or your local regulations. The device may also be returned to the manufacturer
for proper recycling.
• The end of the battery life is indicated by the expiry date printed on the label. Accuracy and proper
function of the device cannot be assured beyond this date.
Useful life
• The devices can be used XXX days, but not longer than 365 days. It depends on the device type
(see technical specifications) and on the condition that:
• The buttons are not pressed for a very long time, e.g. if jammed between the goods in a shipment.
• Storage and operation of the device should remain inside the recommendations of the
manufacturer, especially temperatures below 0&deg;C or 32&deg;F could have a negative influence on the
operating lifetime of the battery.
Attention
All devices of the Q-tag CLm doc family monitor temperature exposures and not the product quality. Its
purpose is to signal if product quality evaluation or testing is required.
Subject to change. Please note that all information in this document is correct at the time of publication.
Due to our policy of continuous product development, we reserve the right to change this information
without prior notice.
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Regulatory certification
Manufactured by:
Berlinger &amp; Co. AG
Mitteldorfstrasse 2
9608 Ganterschwil
SWITZERLAND
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7. Q-tag CLm doc L User Guide Videos
Visit our website under www.berlinger.com/videos or subscribe to our YouTube Channel Berlinger &amp; Co.
AG for streaming our user guide videos online.
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8. Firmware
Device
Firmware
CLm doc
4.8.02
CLm doc L
4.8.02
CLm doc LR
4.8.02
CLm doc D
4.8.02
CLm doc Ice
4.8.02
CLm doc Ice R 4.8.02
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9. FAQ / Glossary
Frequently Asked Questions (FAQ)
For technical problems or questions, please visit the Berlinger Support Center: FAQ – Q-tag CLm doc
Family
Glossary of Terms
Abbreviation Title
SOP
Description
Standard
Standard Operating Procedure (short SOP) is a binding textual description of
Operating
Procedure
the processes of procedures including the examination of results and their
documentation.
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Key Features

Precise temperature monitoring
Data logging & reporting
Alarm system
Start delay
Marker function
USB connectivity

Frequently Answers and Questions

How do I activate the Q-tag CLm doc device?

To activate the device, press and hold the START/STOP button until the display lights up. The device will start recording temperature data once activated.

What does the ALARM symbol on the display mean?

The ALARM symbol indicates that the monitored goods have been exposed to temperatures outside the preset alarm parameters. Check the device for details about the alarm events.

How do I read the data from the device?

Connect the device to a computer via USB. The device will generate PDF and ASCII files containing the temperature data. The data can be viewed on the computer in the PDF report or the raw data in the ASCII file.