berlinger Fridge-tag Ultra Low User manual

User Manual Fridge-
tag Ultra Low
1 — Last update: Dec 02, 2020
Berlinger & Co. AG
Copyright © 2020 Berlinger & Co. AG

Table of Contents
1. Home .................................................................................................................................................. 2
2. Important Information ....................................................................................................................... 3
3. Display explanations ......................................................................................................................... 7
4. State of delivery / sleep mode .......................................................................................................... 8
5. Read out information prior to activation (in sleep mode) ............................................................... 9
6. Placing the Fridge-tag ..................................................................................................................... 11
7. Activation process .......................................................................................................................... 12
7.1. Activation of the device ............................................................................................................ 13
7.2. Setting the calendar format ...................................................................................................... 14
7.3. Using the READ and the SET buttons ...................................................................................... 15
7.4. Setting the date........................................................................................................................ 16
7.5. Setting the time ........................................................................................................................ 18
7.6. Setting the alarm limits (not standard, only if preset by factory) ................................................ 20
7.7. Connection error (external sensor only).................................................................................... 23
8. Read and change settings / How to correct setting mistakes....................................................... 24
8.1. Initial menu (read and change settings).................................................................................... 25
9. Screen displays during measurement mode.................................................................................. 27
10. Alarm trigger function ................................................................................................................... 29
10.1. Alarm display and confirmation options .................................................................................. 31
10.2. Cumulative daily time above/below the limit ........................................................................... 35
11. Audio alarm (optional factory setting).......................................................................................... 36
12. Reading the history / Readout mode ............................................................................................ 37
12.1. Option 1: Read out day per day directly on the device (30-day history) .................................. 38
12.2. Option 2: Read out alarms directly on the device – use the Alarm Super Jump function (30-day
history) .................................................................................................................................................. 41
12.3. Option 3: Read out data from the files generated by the Fridge-tag by connecting it with a
computer ............................................................................................................................................... 43
12.4. PDF report explanation .......................................................................................................... 46
12.5. Autoscaling of graphs in PDF ................................................................................................. 49
12.6. Temperature record duration (optional factory setting) ........................................................... 50
12.7. Verification process................................................................................................................ 51
13. Explanations of terms ................................................................................................................... 53
14. Expire code explanation................................................................................................................ 54
15. Firmware ........................................................................................................................................ 55
16. Glossary......................................................................................................................................... 56

17. Glossary of Symbols ..................................................................................................................... 57

1. Home
Berlinger Fridge-tag Ultra Low
Proven Fridge-tag quality for ultra-low temperatures
The Fridge-tag Ultra Low is the intelligent temperature logger for the continuous monitoring of sensitive
vaccines and pharmaceuticals stored at ultra-low temperatures down to -95°C / -139°F.
If an alarm limit is exceeded, an alarm will be triggered on the display and audible notification will be
given. A quick decision and immediate action are thus possible.
With the built-in USB connection, a secure PDF/A report, with all relevant temperature data presented in
a clear and easy understandable overview including temperature graphs, can be generated.
• Coolest operating temperature with external sensor: –95°C to +0°C / –139°F to +32°F
• Up to 3 years operating time
• User-friendly, reliable and high-precision
Intended purpose of the Fridge-tag Ultra Low
The intended purpose of the Fridge-tag Ultra Low is to measure temperature in a freezer and create a
(summary) report upon user request.
Technical Specification
Product Information Overview
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 2 of 57

2. Important Information
Ensure safety of the products kept in freezer
The Fridge-tag Ultra Low monitors temperature of freezer, not of product itself. The user is at any time
responsible for the judgement if the product can safely be used. The Fridge-tag Ultra Low does never
make this judgement.
The user must verify that no temperature excursion is noted by the Fridge-tag Ultra Low before a product
is taken from freezer. If a temperature excursion is detected, the user may have certain obligations
established by (local) regulation. It is the user’s responsibility to understand these regulatory obligations
and to act accordingly.
Local regulatory requirements / other restrictions
Temperature monitoring of pharmaceutical products, including immunization products, may be subject to
(local) regulation that describes how temperature monitoring should be carried out by personnel and
what tools must be used. To be in compliance with (local) regulation, the user of the Fridge-tag Ultra Low
may be required to carry out additional tasks for example: inspection, verification, signing, and archival.
The Fridge-tag Ultra Low may assist the user with these tasks but does not necessarily perform any or
all tasks required for the user to be compliant with (local) regulation.
Berlinger does not guarantee that the Fridge-tag Ultra Low and supportive systems comply with any
regulation. The Fridge-tag Ultra Low and supportive tools/systems only comply with standards as
provided in respective data sheets. Consult with (local) authorities on how to ensure compliance.
Warnings & Precautions
Points to be addressed by the user are, but not limited to:
• The Fridge-tag Ultra Low must be properly mounted. The external temperature sensor must be
correctly installed and attached to Fridge-tag Ultra Low as described in this manual. Ensure that
the display of the Fridge-tag Ultra Low can be read and the audible warnings can be heard by
personnel operating the freezer.
• The Fridge-tag Ultra Low must be activated as described in this manual.
• The user needs to inspect the Fridge-tag Ultra Low, temperature sensor and freezer equipment
regularly, typically at least once per working day.
• The user needs to ensure that physical access to the Fridge-tag Ultra Low and the freezer is
limited to authorized personnel only. Failing to do so can lead to malicious manipulation of the
measurement system e.g. removal of temperature sensor or Fridge-tag Ultra Low, unauthenticated
use of the device, such as alarm confirmation, unauthorized access to information, unauthorized
configuration change / settings change / date time change.
• The user needs to provide training to personnel.
• When a critical alarm is raised by the device, the user is required to investigate the root cause and
confirm the alarm on the device. Without alarm confirmation, the device assumes that the root
cause has not been solved and will not raise a new alarm. The device does not document who
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 3 of 57

confirmed the alarm. If the user needs this information, the documentation is responsibility of
customer, including limiting the physical access to the device.
• The Fridge-tag Ultra Low carries a unique identifier. The user needs to document which freezer
the Fridge-tag Ultra is monitoring in which time span, if needed for the user to comply with
regulation. Additionally, the user needs to document the unique identifier of the temperature
sensor used and its calibration certificate.
• In order to have a sound administration (as may be required by regulation), the user needs to
ensure that the date and time on the Fridge-tag Ultra Low is correct. It is strongly recommended
that the UTC time zone is used, to prevent issues with daylight saving time. However, when
another time zone is used, the manufacturer recommends documentation (in SOP) when the date/
time on the Fridge-tag Ultra Low is adjusted and by whom. It is the user’s responsibility to ensure
that data of Fridge-tag Ultra Low can be correlated with other information, such as inventory kept
in freezer.
• Before digital reports of Fridge-tag Ultra Low are used, the user must validate their authenticity
using the Verifier. The Verifier can be obtained on Berlinger website. Use of the Verifier is required
to achieve compliance with 21 CFR Part 11 requirements.
Other considerations
• The Fridge-tag Ultra Low has no notion of what correct storage conditions are of the products the
user stores in freezer. The user is assumed to be aware of what is correct and must be able to
assess the impact of measured temperature in a freezer on his products.
• The Fridge-tag Ultra Low has no notion of what the user stores in the freezer, hence the user must
document and manage that himself. Additionally, the correlation between measured temperature
and the product(s) must be done by the user himself.
• Information generated by Fridge-tag Ultra Low is lost, unavailable or unreliable:
- When the Fridge-tag Ultra Low is damaged, defective, is used beyond its expiration date or
indicates ‘empty battery’.
- When external sensor is not attached or is defective.
- When the (digital) report is not archived before older data is overwritten. The maximum report
length (counted from the current moment) is defined. The Fridge-tag Ultra Low does not warn
when older information is overwritten.
- When the calibration of the temperature sensor has expired.
• The Fridge-tag Ultra Low is compatible with Berlinger SmartView. When the user has a Berlinger
SmartView license, the information of Fridge-tag Ultra Low must be uploaded manually to
Berlinger SmartView. Berlinger SmartView assumes that the time and date have been set correctly
on Fridge-tag Ultra Low. When Berlinger SmartView is used to analyze recorded temperature data
of Fridge-tag Ultra Low, it may present different duration values than the Fridge-tag Ultra Low
itself. This is due to the fact that the devices measure and analyses temperature on a minute
interval, while Berlinger SmartView analyses the data on (given) logging interval. The difference in
event duration can be up to two (2) times the logging interval.
• Berlinger gives no guarantees that the Fridge-tag Ultra Low is compatible with third party servers
or systems, or that any or all functions of the device work when used with third party systems.
Even if at the time of purchase the device is compatible, future compatibility is not guaranteed in
any respect.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 4 of 57

Battery
The Fridge-tag Ultra Low contains a coin cell Lithium battery. Please, pay strict attention to the following
points:
• The housing of the Fridge-tag Ultra Low must never be opened nor destroyed.
• Never expose the Fridge-tag Ultra Low to high temperatures (fire, oven, microwaves, etc.). It may
cause injuries.
• Always keep the Fridge-tag Ultra Low out of the reach of children.
• The battery complies with IATA DGR Packaging Instruction 970 Section 2.
• Dispose or recycle the Fridge-tag Ultra Low 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.
Useful life
The device can be used up to 3 1/2 years after production date (1/2 year storage / 3 years useful life) on
the condition that:
• the buttons are not pressed for very long time.
Note: Avoid jamming the device between the goods to be monitored in freezer.
• storage and operation of the device remains inside the recommendations of the manufacturer.
Especially temperatures below 0°C or +32°F could have a negative influence for the operating
lifetime of the battery.
The end of the lifetime of the battery is indicated by the battery indicator on the display (see
chapter Display explanations).
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 or use of the device.
• for any problems with the temperature-controlling and/or-cooling unit.
• for the quality of any monitored goods.
• for incorrect readings if the device was used beyond its expiry date.
Additional terms and conditions may apply. Refer to your purchase order agreement for more
information.
Warranty: 2 years from date of delivery.
The Seller guarantees that the products supplied are functional and free of material or manufacturing
flaws.
This warranty shall only apply provided the products concerned are handled and stored correctly and in
accordance with their instructions for use. In particular, the Seller cannot provide any such warranty in
connection with normal wear and tear or in the event of improper handling, non-compliance with the
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 5 of 57

instructions provided, excessive force, excessive use, accident or force majeure.
It is the responsibility of the Buyer to inspect the products immediately upon receipt. Any perceived
defects must be communicated to the Seller in detail and in writing without delay, and within seven
working days at the latest after such receipt. Any product defects detected at a later stage which were
not identified upon receipt (hidden defects) shall be reported to the Seller immediately, in detail and in
writing.
The Seller’s warranty on the products supplied shall expire two years after the transfer of the associated
benefits and risks (see General Terms and Conditions, para. 4 above). Such warranty shall also expire
immediately and in its entirety if the Buyer or any third party makes any changes or repairs to the
product(s) concerned without the Seller’s written approval.
Should the Seller be required to fulfil a warranty obligation, the Seller shall be free to decide whether to
repair or replace the product(s) concerned.
In such an event, the Buyer shall have no further claims on the Seller. In particular, the Buyer shall have
no entitlement to any reduction in the purchase price, to the cancellation of the purchase agreement or
to compensation for any direct or indirect damages.
In addition, any liability of the Seller arising from or in connection with deliveries shall be excluded, to the
extent permitted by law, irrespective of the legal basis.
Regulatory certification
Manufactured by:
Berlinger & Co. AG
Mitteldorfstrasse 2
9608 Ganterschwil
SWITZERLAND
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 6 of 57

3. Display explanations
1. (OK symbol) or (alarm symbol)
2. Daily HIGH/LOW alarm indicators (showing the history of the last 30 days)
3. Power indicator (colon is flashing)
4. Battery indicator (indicates the remaining capacity of the battery)
5. Additional warning symbol
6. Time, duration and text display
7. Date and text display
8. Display of measured minimum/maximum temperature
9. Temperature display
10. Display of the temperature measurement unit (°F/°C)
11. Display of the activated sensor:
Int. = internal sensor
Ext. = external sensor (cable with temperature sensor)
Note: All illustrations in the User Manual refer to the Fridge-tag with internal sensor. Differences
between internal and external sensors are additionally described.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 7 of 57

4. State of delivery / sleep mode
The Fridge-tag is shipped in sleep mode.
The display (LCD) is blank.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 8 of 57

5. Read out information prior to activation
(in sleep mode)
The following page shows which information will be indicated on the screen upon successive READ
button pressings while in sleep mode.
Note: After approx. 60 seconds without to press any button of the Fridge-tag the devices goes back into
sleep mode; the display is blank again. Start from the beginning.
Press repeatedly READ to gather information.
After 1st pressing of
READ
Display test:
all segments activated
After 2nd pressing of
READ
Indication of date and production test
result: 16 February 2018/PASS (quality
check passed)
After 3rd pressing of
READ
Indication of the current
temperature and which sensor
is activated (internal/external).
Display shows —.-°C if external
sensor is not connected.
After 4th pressing of
READ
Indication of configuration ID
(e.g. 1234)
After 5th pressing of
READ *
Indication of upper alarm settings.
Example shows duration and temperature
limits: 10 hours, >+8°C, high
After 6th pressing of
READ *
Indication of lower alarm settings. Example
shows duration and temperature
limits: 1 hour, <–0.5°C, low
After 7th pressing of
READ Serial number of the device
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 9 of 57

After 8th pressing of
READ
PCb number
(manufacturer information)
After 9th pressing of
READ
Battery power:
3 bars = full (>70%)
2 bars = half-full (>30–70%)
1 bar = low (0–30%)** **Device should be
replaced.
After 10th pressing of
READ The display is blank again.
*Only indicated if preset by factory, otherwise skipped.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 10 of 57

6. Placing the Fridge-tag
Placing the Fridge-tag with an external sensor
Warning: Pay attention to your safety and protection when installing the external sensor in your freezer
and follow your organization’s instructions for proper handling at ultra-low temperatures.
Two hours before activating the Fridge-tag the external sensor must be placed in its predetermined
location. It is recommended and important to place the external sensor in the center of the freezer for an
optimal temperature observation and to avoid any incorrect measurements when starting the device.
For the right positioning of the external sensor within the freezer, please follow the instructions of WHO,
CDC or any other governmental requirements of your country.
1. External Sensor
2. Flat cable
3. Fridge-tag
Note: Do not bend or fold the cable of the external sensor to prevent it from getting damaged. The
bending radius should not be smaller than 1 cm / 0.4 inch.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 11 of 57

7. Activation process
Overview: sequences of activation
*If “Disable User Clock Adjust” in the configuration is enabled points “Setting the date” and “Setting the
time” are skipped upon activation
Note: As long as the activation process has not been completed, after approx. 60 seconds without any
button operation, the device will go back into sleep mode. The activation has to be started from the
beginning.
If you want to read or change settings (e.g. change °F to °C) after the activation has been completed,
proceed as described in chapter Read and change settings / How to correct setting mistakes.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 12 of 57

7.1. Activation of the device
To activate the device press, the SET and the READ button simultaneously during at least 3 seconds.
Note: Once the device is activated, it cannot be stopped anymore.
Activation has been successful when the following indication appears on the screen:
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 13 of 57

7.2. Setting the calendar format
Option 1: Setting the calender format to: dd.mm.yyyy
Press SET to save the calendar format.
Option 2: Setting the calender format to: mm.dd.yyyy
1. Press READ to change the calendar format.
2. Then press SET to save the calendar format.
After setting the calendar format, the first digit of the date will start flashing.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 14 of 57

7.3. Using the READ and the SET buttons
READ button
The READ button is used to adjust the numbers. Each time you press the READ button, the number in
the flashing digit will increase by 1. If you press READ more than necessary, continue pressing the
READ button until you obtain the desired number.
Press READ to adjust the number
SET button
The SET button is used to save the number. After pressing the SET button, the next digit will start
flashing.
Press SET to confirm.
Note: If SET is pressed mistakenly, continue with the setup instructions. This chapter describes how to
rectify the error.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 15 of 57

7.4. Setting the date
The following example shows how to set the date to:
16 February 2018 (16.02.2018) in European format.
The 1st
digit is
flashing.
1. Press READ until “1”
appears as the first
digit.
2. Press SET to save.
The 2nd
digit is
flashing.
1. Press READ until “6”
appears as the
second digit.
2. Press SET to save
The 3rd
digit is
flashing.
1. Press READ until “0”
appears as the third
digit.
2. Press SET to save.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 16 of 57

The 4th
digit is
flashing.
1. Press READ until “2”
appears as the fourth
digit.
2. Press SET to save.
Note: The fifth and
the sixth digit are set
automatically.
The 7th
digit is
flashing.
1. Press READ until “1”
appears as the
seventh digit.
2. Press SET to save.
The 8th
digit is
flashing.
1. Press READ until “8”
appears as the eighth
digit.
2. Press SET to save.
The date is now set to: 16.02.2018.
Note: After setting the date, the first digit of the time will start flashing.
Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1
Page 17 of 57