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 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 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 2 L carries a unique identifier. The user needs to document which refrigerator/freezer the Fridge-tag 2 L 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 required by regulation), the user needs to ensure that the date and time on the Fridge-tag 2 L 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 2 L is adjusted and by whom. It is the user’s responsibility to ensure that data of Fridge-tag 2 L can be correlated with other information, such as inventory kept in refrigerator/freezer.
- Before digital reports of Fridge-tag 2 L are used, the user must validate their authenticity using the Verifier. The Verifier can be obtained on Berlinger website.
Other considerations
- The Fridge-tag 2 L has no notion of what correct storage conditions are of the products the user stores in refrigerator/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 refrigerator/freezer on his products.
- The Fridge-tag 2 L has no notion of what the user stores in the refrigerator/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 2 L is lost, unavailable or unreliable:
- When the Fridge-tag 2 L 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 2 L does not warn when older information is overwritten.
- When the calibration of the temperature sensor has expired. - The Fridge-tag 2 L is compatible with Berlinger SmartView. When the user has a Berlinger SmartView license, the information of Fridge-tag 2 L must be uploaded manually to Berlinger SmartView. Berlinger SmartView assumes that the time and date have been set correctly on Fridge-tag 2 L. When Berlinger SmartView is used to analyze recorded temperature data of Fridge-tag 2 L, it may present different duration values than the Fridge-tag 2 L 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 2 L is compatible with third party servers or systems, or that all functions of the device work when used with third party systems. Even if at moment of purchase the device is compatible, no guarantee is given for future.
Haftung
Der Hersteller kann nicht haftbar gemacht werden für:
- den Einsatz des Gerätes ausserhalb der im Datenblatt spezifizierten Grenzwerte.
- alle Ansprüche, die aus unsachgemässer Lagerung und/oder Gebrauch des Gerätes entstehen.
- jegliche Probleme im Zusammenhang mit der Temperaturregeleinrichtung.
- die Qualität der überwachten Güter.
- fehlerhafte Messwerte, falls das Gerät nach dessen Verfallsdatum betrieben wird.
Gewährleistung: 2 Jahre nach dem Lieferdatum.
Batterie
Der Fridge-tag 2 L enthält eine CR-Lithium-Batterie. Bitte beachten Sie folgende Instruktionen sorgfältig:
- Das Gehäuse des Fridge-tag 2 L darf nie geöffnet oder zerstört werden.
- Setzen Sie den Fridge-tag 2 L nie hohen Temperaturen aus (z.B.: Feuer, Herd, Ofen, Mikrowelle usw.) Dabei besteht eventuell Verletzungsgefahr!
- Das Gerät immer ausserhalb der Reichweite von Kindern aufbewahren.
- Die Batterie entspricht der IATA-DGR-Packaging-Instruktion 970 Sektion II.
- Der Fridge-tag 2 L soll in Übereinstimmung mit den WEEE 2012/19/EU oder den lokalen Richtlinien entsorgt/wiederverwertet werden. Das Gerät kann zur fachgerechten Wiederverwertung auch an den Hersteller retourniert werden.
Lebensdauer
Das Gerät kann bis zu 31/2 Jahre nach Produktionsdatum verwendet werden (1/2 Jahr Lagerung / 3 Jahre Lebensdauer), unter den Bedingungen dass:
- die Tasten nicht über eine längere Zeit betätigt werden
Hinweis: Vermeiden Sie dass das Gerät zwischen den zu überwachenden Gütern eingeklemmt wird. - die Lagerung und der Einsatz der Geräte innerhalb der vom Hersteller vorgegebenen Grenzen stattfindet. Vor allem sehr niedrige Temperaturen tiefer als 0 °C oder +32 °F sind zu vermeiden, denn sie können die Betriebsdauer der Batterie verringern.
Das Ende der Lebensdauer der Batterie wird durch die Batterieanzeige auf der Anzeige angezeigt (siehe Kapitel Erklärung der Anzeige).
Achtung
- Der Fridge-tag 2 L misst die Umgebungstemperatur und nicht die Qualität der überwachten Güter. Sein Zweck ist die Anzeige, ob eine Prüfung der Produktqualität erforderlich ist.
Änderungen vorbehalten. Bitte beachten Sie, dass alle Informationen in diesem Dokument zum Zeitpunkt der Veröffentlichung korrekt sind. Aufgrund unserer kontinuierlichen Produktentwicklung behalten wir uns das Recht vor, diese Informationen ohne vorherige Ankündigung zu ändern.
Regulatorische Zertifizierung
Hergestellt von:
Berlinger & Co. AG Mitteldorfstrasse 2 9608 Ganterschwil SWITZERLAND |