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
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