Wichtige Hinweise; Ensure Safety Of The Products Kept In Refrigerator/Freezer - Berlinger Fridge-tag 2 L Bedienungsanleitung

Berlinger & Co. AG

14. Wichtige Hinweise

Intended purpose of the Fridge-tag 2 L
The intended purpose of the Fridge-tag 2 L is to measure temperature in a refrigerator/freezer and
create a (summary) report upon user request.

Ensure safety of the products kept in refrigerator/freezer

The Fridge-tag 2 L monitors temperature of refrigerator/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 2 L does never
make this judgement.
The user must verify that no temperature excursion is noted by the Fridge-tag 2 L before a product is
taken from refrigerator/freezer. If temperature excursion is detected, the user is responsible to act as
given by (local) regulation.
Local regulatory requirements / other restrictions
Temperature monitoring of pharmaceutical products, including immunization products, is subject to
(local) regulation. The regulation 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 2 L may be required to carry out additional tasks for example: inspect, verify, sign and
archive. The Fridge-tag 2 L may assist the user with these tasks but does not perform all possibly
required tasks for the user to be compliant with regulation.
Berlinger does not guarantee that the Fridge-tag 2 L and supportive systems comply to regulation. The
Fridge-tag 2 L and supportive tools/systems only comply with standards as provided in respective data
sheets. Consult with (local) authorities on how to ensure compliance.
Points to be addressed by the user are, but not limited to:
• The Fridge-tag 2 L must be properly mounted. The external temperature sensor must be correctly
installed and attached to Fridge-tag 2 L as described in this manual. Ensure that the display of the
Fridge-tag 2 L can be read and the audible warnings can be heard by personnel operating the
refrigerator/freezer.
• The Fridge-tag 2 L must be activated as described in this manual.
• The user needs to inspect the Fridge-tag 2 L, temperature sensor and refrigerator/freezer
equipment regularly, typically at least once per working day.
• The user needs to ensure that physical access to the Fridge-tag 2 L and the refrigerator/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 2 L, 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
User Manual Fridge-tag 2 L - 1
Seite 52 von 57