Informations importantes

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.

Responsabilité

Le fabricant ne sera pas tenu responsable:

Si le dispositif a été utilisé au-delà des limites indiquées par le fabricant.
Des réclamations dues au stockage et à lʼutilisation inadaptés du dispositif.
Des problèmes de lʼunité de contrôle de la température et / ou de refroidissement.
De la mauvaise qualité des produits contrôlés.
Des lectures incorrectes si le dispositif est utilisé au-delà de sa date dʼexpiration.
Garantie: 2 ans à compter de la date de livraison (voir les conditions générales de Berlinger)

Batterie

Le Fridge-tag 2 L contient une batterie CR au lithium. Les points suivants sont particulièrement importants:

Il ne faut en aucun cas ouvrir ou détruire le boîtier du Fridgetag 2 L.
Il ne faut jamais exposer le Fridge-tag 2 L à des températures supérieures à la plage autorisée (incendie, four, micro-ondes etc.). Il pourrait en effet provoquer des blessures.
Toujours tenir le Fridge-tag 2 L hors de portée des enfants.
La batterie satisfait aux instructions dʼemballages 970 (IATA DGR) Partie 2.
Jeter ou recycler le Fridge-tag 2 L en respectant les directive WEEE 2012/19/EU ou la réglementation locale. Le dispositif peut également être renvoyé au fabricant qui se chargera de son recyclage.

Vie utile

Les dispositifs peuvent être utilisés pendant 3 1/2 ans (1/2 ans stockage / 3 ans vie utile), après leur date de fabrication dans les conditions suivantes:

Les boutons ne doivent pas être enfoncés pendant de longues périodes, (par ex. sʼils se trouvaient coincés entre des produits dans un envoi).
Le stockage et le fonctionnement du dispositif doivent rester conformes aux recommandations du fabricant; particulièrement températures inférieures 0°C ou +32°F pourrait avoir une influence négative sur la durée de vie utile de la batterie.
La fin de la vie utile est indiquée par lʼindicateur de batterie faible sur lʼaffichage (voir chapitre Explication dʼaffichage).

Attention

Fridge-tag 2 L surveille la température et non pas la qualité des produits. Son rôle est de signaler si une évaluation ou un test de la qualité des produits est requis.

Sous réserve de modifications. Veuillez noter que toutes les informations figurant dans ce document sont données pour correctes au moment de la publication. Cependant nous nous réservons le droit de modifier ces informations à tout moment et sans préavis dans le cadre de notre politique de développement continue des produits.