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 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.
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 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:
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Berlinger & Co. AG Mitteldorfstrasse 2 9608 Ganterschwil SWITZERLAND |
