Berlinger Fridge-tag Ultra Low User Manual
The berlinger Fridge-tag Ultra Low is a temperature logger designed for continuous monitoring of sensitive vaccines and pharmaceuticals at ultra-low temperatures down to -95°C / -139°F. It provides audible and visual alarms when temperature limits are exceeded, enabling quick decision-making and immediate action. The Fridge-tag Ultra Low also allows the generation of secure PDF/A reports with clear temperature data and graphs, making it convenient for data analysis and documentation.
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User Manual Fridgetag Ultra Low 1 — Last update: Feb 03, 2021 Berlinger & Co. AG Copyright © 2021 Berlinger & Co. AG Table of Contents 1. Home .................................................................................................................................................. 1 2. Important Information ....................................................................................................................... 2 3. Display explanations ......................................................................................................................... 6 4. State of delivery / sleep mode .......................................................................................................... 7 5. Read out information prior to activation (in sleep mode) ............................................................... 8 6. Placing the Fridge-tag ..................................................................................................................... 10 7. Activation process .......................................................................................................................... 11 7.1. Activation of the device ............................................................................................................ 12 7.2. Setting the calendar format ...................................................................................................... 13 7.3. Using the READ and the SET buttons ...................................................................................... 14 7.4. Setting the date ........................................................................................................................ 15 7.5. Setting the time ........................................................................................................................ 17 7.6. Setting the alarm limits (not standard, only if preset by factory) ................................................ 19 7.7. Connection error (external sensor only).................................................................................... 22 8. Read and change settings / How to correct setting mistakes....................................................... 23 8.1. Initial menu (read and change settings) .................................................................................... 24 9. Screen displays during measurement mode.................................................................................. 26 10. Alarm trigger function ................................................................................................................... 28 10.1. Alarm display and confirmation options .................................................................................. 30 10.2. Cumulative daily time above/below the limit ........................................................................... 34 11. Audio alarm (optional factory setting).......................................................................................... 35 12. Reading the history / Readout mode ............................................................................................ 36 12.1. Option 1: Read out day per day directly on the device (30-day history) .................................. 37 12.2. Option 2: Read out alarms directly on the device – use the Alarm Super Jump function (30-day history) .................................................................................................................................................. 40 12.3. Option 3: Read out data from the files generated by the Fridge-tag by connecting it with a computer ............................................................................................................................................... 42 12.4. PDF report explanation .......................................................................................................... 45 12.5. Autoscaling of graphs in PDF ................................................................................................. 48 12.6. Temperature record duration (optional factory setting) ........................................................... 49 12.7. Verification process ................................................................................................................ 50 13. Explanations of terms ................................................................................................................... 52 14. Expire code explanation................................................................................................................ 53 15. Firmware ........................................................................................................................................ 54 16. Glossary ......................................................................................................................................... 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 1. Home Berlinger Fridge-tag Ultra Low Proven Fridge-tag quality for ultra-low temperatures The Fridge-tag Ultra Low is the intelligent temperature logger for the continuous monitoring of sensitive vaccines and pharmaceuticals stored at ultra-low temperatures down to -95°C / -139°F. If an alarm limit is exceeded, an alarm will be triggered on the display and audible notification will be given. A quick decision and immediate action are thus possible. With the built-in USB connection, a secure PDF/A report, with all relevant temperature data presented in a clear and easy understandable overview including temperature graphs, can be generated. • Coolest operating temperature with external sensor: –95°C to +0°C / –139°F to +32°F • Up to 3 years operating time • User-friendly, reliable and high-precision Intended purpose of the Fridge-tag Ultra Low The intended purpose of the Fridge-tag Ultra Low is to measure temperature in a freezer and create a (summary) report upon user request. Technical Specification Product Information Overview Page 1 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 2. Important Information 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 Page 2 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 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. Page 3 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 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 Page 4 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 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: Berlinger & Co. AG Mitteldorfstrasse 2 9608 Ganterschwil SWITZERLAND Page 5 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 3. Display explanations 1. (OK symbol) or (alarm symbol) 2. Daily HIGH/LOW alarm indicators (showing the history of the last 30 days) 3. Power indicator (colon is flashing) 4. Battery indicator (indicates the remaining capacity of the battery) 5. Additional warning symbol 6. Time, duration and text display 7. Date and text display 8. Display of measured minimum/maximum temperature 9. Temperature display 10. Display of the temperature measurement unit (°F/°C) 11. Display of the activated sensor: Int. = internal sensor Ext. = external sensor (cable with temperature sensor) Note: All illustrations in the User Manual refer to the Fridge-tag with internal sensor. Differences between internal and external sensors are additionally described. Page 6 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 4. State of delivery / sleep mode The Fridge-tag is shipped in sleep mode. The display (LCD) is blank. Page 7 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 5. Read out information prior to activation (in sleep mode) The following page shows which information will be indicated on the screen upon successive READ button pressings while in sleep mode. Note: After approx. 60 seconds without to press any button of the Fridge-tag the devices goes back into sleep mode; the display is blank again. Start from the beginning. Press repeatedly READ to gather information. After 1st pressing of READ Display test: all segments activated After 2nd pressing of READ Indication of date and production test result: 16 February 2018/PASS (quality check passed) After 3rd pressing of READ Indication of the current temperature and which sensor is activated (internal/external). Display shows —.-°C if external sensor is not connected. After 4th pressing of READ Indication of configuration ID (e.g. 1234) After 5th pressing of READ * Indication of upper alarm settings. Example shows duration and temperature limits: 10 hours, >+8°C, high After 6th pressing of READ * Indication of lower alarm settings. Example shows duration and temperature limits: 1 hour, <–0.5°C, low After 7th pressing of READ Serial number of the device Page 8 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 After 8th pressing of READ PCb number (manufacturer information) After 9th pressing of READ Battery power: 3 bars = full (>70%) 2 bars = half-full (>30–70%) 1 bar = low (0–30%)** **Device should be replaced. After 10th pressing of READ The display is blank again. *Only indicated if preset by factory, otherwise skipped. Page 9 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 6. Placing the Fridge-tag Placing the Fridge-tag with an external sensor Warning: Pay attention to your safety and protection when installing the external sensor in your freezer and follow your organization’s instructions for proper handling at ultra-low temperatures. Two hours before activating the Fridge-tag the external sensor must be placed in its predetermined location. It is recommended and important to place the external sensor in the center of the freezer for an optimal temperature observation and to avoid any incorrect measurements when starting the device. For the right positioning of the external sensor within the freezer, please follow the instructions of WHO, CDC or any other governmental requirements of your country. 1. External Sensor 2. Flat cable 3. Fridge-tag Note: Do not bend or fold the cable of the external sensor to prevent it from getting damaged. The bending radius should not be smaller than 1 cm / 0.4 inch. Page 10 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7. Activation process Overview: sequences of activation *If “Disable User Clock Adjust” in the configuration is enabled points “Setting the date” and “Setting the time” are skipped upon activation Note: As long as the activation process has not been completed, after approx. 60 seconds without any button operation, the device will go back into sleep mode. The activation has to be started from the beginning. If you want to read or change settings (e.g. change °F to °C) after the activation has been completed, proceed as described in chapter Read and change settings / How to correct setting mistakes. Page 11 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.1. Activation of the device To activate the device press, the SET and the READ button simultaneously during at least 3 seconds. Note: Once the device is activated, it cannot be stopped anymore. Activation has been successful when the following indication appears on the screen: Page 12 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.2. Setting the calendar format Option 1: Setting the calender format to: dd.mm.yyyy Press SET to save the calendar format. Option 2: Setting the calender format to: mm.dd.yyyy 1. Press READ to change the calendar format. 2. Then press SET to save the calendar format. After setting the calendar format, the first digit of the date will start flashing. Page 13 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.3. Using the READ and the SET buttons READ button The READ button is used to adjust the numbers. Each time you press the READ button, the number in the flashing digit will increase by 1. If you press READ more than necessary, continue pressing the READ button until you obtain the desired number. Press READ to adjust the number SET button The SET button is used to save the number. After pressing the SET button, the next digit will start flashing. Press SET to confirm. Note: If SET is pressed mistakenly, continue with the setup instructions. This chapter describes how to rectify the error. Page 14 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.4. Setting the date The following example shows how to set the date to: 16 February 2018 (16.02.2018) in European format. 1. Press READ until “1” The 1st digit is flashing. appears as the first digit. 2. Press SET to save. 1. Press READ until “6” The 2nd digit is flashing. appears as the second digit. 2. Press SET to save 1. Press READ until “0” The 3rd digit is flashing. appears as the third digit. 2. Press SET to save. Page 15 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 1. Press READ until “2” appears as the fourth The 4th digit is flashing. digit. 2. Press SET to save. Note: The fifth and the sixth digit are set automatically. 1. Press READ until “1” The 7th digit is flashing. appears as the seventh digit. 2. Press SET to save. 1. Press READ until “8” The 8th digit is flashing. appears as the eighth digit. 2. Press SET to save. The date is now set to: 16.02.2018. Note: After setting the date, the first digit of the time will start flashing. Page 16 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.5. Setting the time This example shows how to set the time to 13:47. Note: The clock operates as a 24-hour clock (e.g. 1:47 pm = 13:47). 1. Press READ until “1” The 1st digit is flashing: appears as the first digit. 2. Press SET to save. 1. Press READ until “3” The 2nd digit is flashing. appears as the second digit. 2. Press SET to save. Page 17 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 1. Press READ until “4” The 3rd digit is flashing. appears as the third digit. 2. Press SET to save. 1. Press READ until “7” The 4th digit is flashing. appears as the fourth digit. 2. Press SET to save. The time is now set to 13:47. Note: If the device is configured with self-programmable alarm limits proceed with the following chapter. As soon as the last digit of the time setting is confirmed, the activation is completed. Connect the device with the external sensor. During max. 1 minute after activation no temperature is displayed on the screen. Page 18 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.6. Setting the alarm limits (not standard, only if preset by factory) This adjustment is done in 4 steps: 1. Setting the duration of the upper alarm limit 2. Setting the temperature of the upper alarm limit 3. Setting the duration to the lower alarm limit 4. Setting the temperature of the lower alarm limit 1. and 3. Setting the HI and LO alarm durations, they are completed in the same manner 1. Press READ to adjust the The 1st digit of the duration of the alarm limit is flashing. number. 2. Press SET to confirm the number. 1. Press READ to adjust the The 2nd digit of the duration of the alarm limit is flashing. number. 2. Press SET to confirm the number. Page 19 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 1. Press READ to adjust the The 3rd digit of the duration of the alarm limit is flashing. number. 2. Press SET to confirm the number. 1. Press READ to adjust the The 4th digit of the duration of the alarm limit is flashing. number. 2. Press SET to confirm the number. The duration of the alarm limit is now set. 2. and 4. Setting the HI and LO alarm temperatures, they are completed in the same manner temperature limits must be not lower than –90°C (–130°F) and no higher than ! Alarm -5°C (+23°F). First you have to choose the range of the desired temperature limit. You have the choice between negative and positive temperatures. In case of a positive limit in Fahrenheit you may further choose if the limit shall be equal or above +100°F. This choice is done by repeatedly pressing READ until the desired range is indicated. Note: The temperature measurement unit (°C/°F) can only be changed after the device is activated in the menu. Learn more. Instruction for setting a positive temperature limit between 0°C/0°F and +55°C/+131°F (external sensor) Page 20 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 1. Press READ until the display shows no flashing sign. 2. Press SET to adjust the limit between 0°C/0°F and +50°C/+122°F. The next digit can now be set. Press READ until you reach the desired number. Then press SET to confirm it. Then the next digit will start flashing. Continue until all digits of the alarm temperature are set. Setting a negative temperature limit below 0°C/0°F 1. Press READ until the “-” sign is flashing. 2. Press SET to set the limit below 0°C/0°F. The next digit can now be set. Press READ until you reach the desired number. Then press SET to confirm it. Then the next digit will start flashing. Continue until all digits of the alarm temperature limits are set. As soon as the parameters of the upper alarm limit are set, the first digit of the duration of the lower alarm limit will start flashing. Proceed the same way as you did with the upper alarm limit. As soon as the last digit of the lower alarm limit is confirmed, the activation is completed. Connect the device with the external sensor. Note: In case the desired temperature limit cannot be confirmed, check if the temperature is set within the allowed operating temperature range. Page 21 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 7.7. Connection error (external sensor only) After 10 minutes (factory standard) without a connection between the device and the external sensor the following display appears and: • The buzzer will beep twice at intervals of three minutes for a maximum of 168 hours (7 days). • The whole display starts blinking. • Any button pressed will stop the display from blinking. • The buzzer only stops if the connection error is corrected. If the error still exists, the buzzer continuously beeps at a three-minute interval for 168 hours (7 days). Display status: external sensor error How to fix the connection error Please check the following two points: 1. If the external sensors properly connected with the device? 2. Does the external sensor cable have any defects? Note: As soon as the error(s) have been cleared, the measuring will continue and the connection error buzzer stops to beep automatically. During max. 1 minute after the connection no temperature is displayed on the screen. During a connection error no data will be recorded. Page 22 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 8. Read and change settings / How to correct setting mistakes Overview: menu *If “Disable User Clock Adjust” in the configuration is enabled point “SET DATE” are skipped upon activation Note: If you scroll through the menu and you reach the display of the measuring mode, you need to restart from the beginning by accessing the menu. In order to adjust more than one setting (e.g. time and Celsius to Fahrenheit) you must complete each change and return to menu mode for the 2nd change. Page 23 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 8.1. Initial menu (read and change settings) To change the date format, the date, the time, the temperature measurement unit or the alarm settings or to read the preset alarm limits please proceed as follows: 1. Press and hold SET … 2. … then press READ shortly … 3. … then release both buttons simultaneously. SET DATE (internal sensor) is now displayed on the screen. OUTSIDE (external sensor) is now displayed on the screen. You entered the menu mode and may choose which entry to see or change. You can access the following 4 menus: OUTSIDE (external sensor): first screen, shows the temperature measured with the internal sensor of the Fridge-tag (normal ambient temperature). Press READ once to get to SET DATE. SET DATE (internal sensor): Configuration with internal sensor, SET DATE is directly shown. 1. SET DATE: change date and/or time settings 2. READ CONF: read the alarm settings 3. CELS FAHR: change the temperature unit 4. SET CONF: change the alarm settings (only if enabled in factory setting) Use the READ button to scroll through the menu. Use the SET button to access the corresponding menu. Access the menu “SET DATE” External sensor: The display shows OUTSIDE. Press READ until the display shows SET DATE. Internal sensor: The display shows the menu “SET DATE”. Press SET to access the menu to adjust the date format, date or time settings. Then follow the steps as described in here. Note: Time and date adjustments have no effect on the alarm records. Adjustments can only be made for date and time settings and for changing the temperature measurement unit. Once the device is Page 24 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 activated, it cannot be stopped anymore. The number of adjustments during the same day is unlimited. After an adjustment has been made, the Fridge-tag will be locked for 24 hours from the following midnight (e.g. changes on 15 September., device locked from 00:01 am on the 16 September until 00:01 am on the 17 September). This is for security reasons. Access the menu “READ CONF” The display shows SET DATE (internal sensor), OUTSIDE (external sensor). Press READ until the display shows READ CONF. Then press SET to access the menu to read the current alarm configurations. First the display check appears. Then press READ repeatedly to scroll through the preset alarm parameters. Access the menu “CELS FAHR” The display shows SET DATE. Press READ until the display shows CELS FAHR. Then press SET to access the menu to change the temperature measurement unit. To change the measurement unit (Celsius/Fahrenheit) press READ until the display shows the desired sign (°C/°F). Press SET to confirm the measurement unit. Access the menu “SET CONF”* The display shows SET DATE. Press READ until the display shows SET CONF. Press SET to access the menu to change the alarm configurations. To change the alarm limits (duration or temperature) please proceed as described in this chapter. *Changes of the alarm limits are only possible for devices which are programmed with this feature. Page 25 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 9. Screen displays during measurement mode Indication for max. 1 minute after completing the activation or after connecting the device with the external sensor. For a maximum of 1 minute no temperature is displayed on the screen, indicated by —.. Example OK display – during measurement Once the device is fully activated the OK symbol , the current temperature reading, the time and the date will be displayed on the screen. The Fridge-tag will also indicate whether the measuring is made with an internal sensor or an external sensor. The OK symbol is shown during normal operation as long as no alarms have been recorded. The temperature and time conditions were within the preset alarm limits. Example alarm display – during measurement If the preset alarm limits are exceeded, the following information will be displayed on the screen: Page 26 of 55 Berlinger & Co. AG • User Manual Fridge-tag Ultra Low - 1 (OK symbol) will be replaced by • An additional alarm indicator (alarm symbol) will be indicated in the upper display area to show which alarm limit has been exceed and on which day. • In addition to the alarm symbol the warning symbol will appear next to it. Page 27 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 10. Alarm trigger function Single-event alarm triggering The upper or lower alarm triggering is done with a single-event alarm algorithm. Any kind of alarm is triggered if the temperature is continuously out of the preset alarm limits for longer than the preset alarm trigger time. Upper alarm triggering Setting upper limit: Temperature >8.0°C, duration >10 hours For the upper alarm to be triggered the temperature needs to be continuously above 8°C for more than 10 hours. Alarm triggered: alarm symbol and warning symbol displayed. In the example below the sum* of the daily upper temperature deviation is about 20 hours. No alarm will be triggered! The temperature was not continuously out of the preset alarm limits for more than 10 hours in one row. No Alarm triggered: OK symbol on the display. *The sum of the deviations is visible in the daily statistics in the column “Cumulative daily time above the Page 28 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 limit.” Lower alarm triggering Setting lower limit: Temperature <–0.5°C, duration >1 hour For a lower alarm to be triggered the temperature needs to be continuously below –0.5°C for more than 1 hour. Alarm triggered: alarm symbol and warning symbol displayed. In the example below multiple low temperature deviations* are occurring. No alarm will be triggered. Each temperature deviation was less than 1 hour out of the preset alarm limits. No Alarm triggered: OK symbol on the display. *The sum of the deviations is visible in the daily statistics in the column “Cumulative daily time below the limit.” Page 29 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 10.1. Alarm display and confirmation options Option 1: Alarm indication “all alarms” With this option the alarms will be visible on the display with an alarm symbol By pressing the READ button, the warning symbol alarm symbol for 30 days. will be disabled for the corresponding alarms. The cannot be canceled nor reset. Note: • In this mode only one upper and one lower alarm will be triggered per day. • The alarm symbol • The warning symbol will be present on the display for 30 days. can be deactivated by confirming all existing alarms in the readout mode. • The alarm buzzer stops when the alarm is confirmed within the set alarm limits. Otherwise the buzzer pauses for approx. 1 hour and starts again for up to 168 hours (7 days). Option 2: Alarm indication “unconfirmed alarms” The alarms are shown with the alarm symbol until all alarms (in the 30-day history) have been Page 30 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 confirmed as solved by pressing the READ button. Afterwards the display will show the OK symbol until a new alarm is triggered. By pressing the READ button the warning symbol alarm symbol disappears and the OK symbol will be disabled for the corresponding alarms. The will be shown again. Confirmation options of currently triggered alarms of the day 1. Device is within the set alarm limits Press the READ button and the alarm symbol and the warning symbol will immediately disappear and the optional buzzer stops. A new alarm will be triggered as soon as the set alarm limits are exceeded again. Settings: upper temperature limit >8.0°C and duration >1 hour, lower temperature limit <–0.5°C and duration 1 hour Page 31 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 1. Alarm triggered: alarm symbol and warning symbol 2. Alarm confirmed within the set temperature limits: 3. Alarm triggered: alarm symbol on display (OK symbol) on display and warning symbol on display. 2. Device is outside the set alarm limits If the READ button is pressed still during a temperature violation the buzzer will be muted for approx. 1 hour. The alarm symbol and the warning symbol will stay on the display for the corresponding alarm. If the temperature still exceeds the limit after 1 hour, the buzzer will restart beeping. Settings: upper temperature limit Temperature >8.0°C and duration >1 hour, lower temperature limit <–0.5°C and duration 1 hour 1. Alarm triggered: alarm symbol and warning symbol on display. 2. Alarm confirmed when the temperature exceeds the set temperature limits: alarm symbol warning symbol and remain on display. 3. Temperature is back within the alarm limits. Now the alarm can be successfully confirmed. OK symbol on display. Note: How the alarm symbol and the warning symbol react is specified during configuration of the Page 32 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 device in the factory settings. Page 33 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 10.2. Cumulative daily time above/below the limit The alarm trigger algorithm is based on a single event, although the Fridge-tag is measuring on a daily basis the individual total time above or below the temperature limits. This measurement is not used for any alarm condition. These recordings are only available in the generated PDF/ASCII files. Note: It could be that the total cumulative time above/below the temperature limits is longer than the configured single-event alarm time without any alarm triggering. Example setup: lower temperature limit <–0.5°C, duration >1 hour In the above example multiple low temperature deviations with exposure times of less than 1 hour occurred. The cumulative daily time below the limits adds up to about 3.5 hours but no alarm will be triggered. The same behavior also applies to the upper alarm. Page 34 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 11. Audio alarm (optional factory setting) In case an upper or lower alarm is triggered, 3 audible alarm signals are emitted immediately. Thereafter: • Every minute 1 alarm signal for maximally 168 hours (7 days). • After 168 hours (7 days) the buzzer will stop. • If an alarm event is confirmed (READ is pressed) while the limits are still exceeded the buzzer pauses for approx. 1 hour and then restarts beeping every 3 minutes. • Confirmation within the alarm limits will stop the buzzer. In case of a connection error see here. Page 35 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12. Reading the history / Readout mode The information of the temperature deviations can either be viewed for the past 30 days directly on the device or for 28/56/84/112 days in the generated files (PDF/ASCII). Note: The external sensor of the Fridge-tag can remain at its location for the readout process. Please consider that there may occur a connection error after more than 10 minutes without connection between the device and the sensor. Page 36 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.1. Option 1: Read out day per day directly on the device (30-day history) Example of an OK display during readout of the history Press READ once The following information is indicated on the screen: • The OK symbol • The corresponding flashing arrow (example: high arrow “today”) • Highest recorded temperature (example: +10.5˚C) • Duration of the exceedance of the preset high limit temperature (example 00:32; hh:min) Press READ a second time The following information is indicated on the screen: • The OK symbol • The corresponding flashing arrow (example: low arrow of “today”) Page 37 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 • Lowest recorded temperature (example: +2.9˚C) • Duration of the exceedance of the preset low temperature limit (example 00:00; hh:min) Note: in the Readout mode the flashing arrows display the day where your are (30-day history) and show the highest and lowest measured temperature of the corresponding day. If a limit has been exceeded also the duration is shown. Note: Press repeatedly the READ button to read out day per day the details of the past 30 days. When you reach an alarm event, the indication on the screen of the Fridge-tag will be different than the OK display. Example of an alarm display during readout of the history 1st display of a “lower alarm event” Press READ once The following information is indicated on the screen: • The alarm- and the warning symbol • The corresponding alarm indicator (lower alarm limit) • Day of alarm (example: 5 days ago: –5d) • The date of the alarm (example: 16.02.2018) • The time of the alarm (example: 18:21) 2nd display of a “lower alarm event” Page 38 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 Press READ a second time The following additional information is indicated on the screen: • Lowest recorded temperature (example: –1.1˚C) • The duration ot the exceedance of the preset low temperature limit (example: 01:35; hh:mm) • Temperature recording in this example with internal sensor Page 39 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.2. Option 2: Read out alarms directly on the device – use the Alarm Super Jump function (30-day history) If you like to read out the alarms directly on the Fridge-tag, press the READ button for at least 3 seconds. 1st display of the latest alarm event Press READ for 3 seconds The following information is indicated on the screen: • The alarm symbol and the warning symbol • The corresponding alarm indicator (higher alarm limit) • Day of alarm (example: 5 days ago: –5d) • The date of the alarm (example: 16.02.2018) • The time of excursion (example: 20:30) 2nd display of the latest alarm event Press READ again Page 40 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 The following additional information is indicated on the screen: • Highest recorded temperature (example: +10.5˚C) • The duration of the exceedance of the preset high temperature limit (example: 11:24; hh:mm.) • Temperature recording in this example with internal sensor Note: Press the READ button again for at least 3 seconds and the next alarm event will appear on the screen. Display of the next alarm event Note: Press the READ button again for 3 seconds to jump to the next alarm event. And so on. Note: Pressing SET in the „Read out Mode“ brings you back to the „Measurement Mode“. Page 41 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.3. Option 3: Read out data from the files generated by the Fridge-tag by connecting it with a computer Plug the Fridge-tag into any computer via USB interface. Make sure the device is plugged in properly. Note: Disconnect the external sensor from the device first. The Fridge-tag will now generate a PDF and ASCII report of the last 28, 56, 84 or 112 days (factory setting). Depending on the configuration, this process may take up to 2 minutes. Now choose the appropriate file generated by the Fridge-tag. USB connection of the Fridge-tag The continuously appearing arrows in the upper display area indicate that the device is operating. Note: This process must not be interrupted until the OK symbol appears on the display. This indicates that the creation of the ASCII and PDF files has been successfully completed. Page 42 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 The hard drive of the Fridge-tag is shown in your explorer. Open the desired file generated by the device. Note: To disconnect the device properly, please always use the function “Safely Remove Hardware” on your PC/Mac. Page 43 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 Right-click the icon “Safely Remove Hardware and Eject Media” in the Windows taskbar (lower right corner). Choose the corresponding device to remove. Do not disconnect the device before you receive the depitcted message, otherwise the device can be damaged. Note: For this process no additional software is necessary. Page 44 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.4. PDF report explanation Sample of a PDF file generated by a Fridge-tag Ultra Low (page 1/2) 1. Document title and device type 2. Device ID and further information 3. Alarm settings 4. Measuring and logging interval 5. Event and alarm table (latest info in line 1, top line) 6. Up to 3 user-defineable strings (max. 30 characters each). Factory preset. 7. Placeholder for notes 8. Note 1: Reference for measurement interval, Note 2: Legend for events column (hh:mm —> 1 time stamp/half day) 9. Placeholder for date/place and signature 10. Battery warning with timestamp Page 45 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 Sample of a PDF file generated by a Fridge-tag Ultra Low (page 2/2) 1. Each graph shows data from a period of 7 days 2. Incrementally numbered graphs 3. Temperature scale 4. Time scale 5. Placeholder for date/place and signature 6. Alarm limits Page 46 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 Graph behavior when date / time is changed manually 1. Date change positive 2. Date change negative 3. Time change positive (e.g. summer/winter time) 4. Time change negative (e.g. summer/winter time) Page 47 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.5. Autoscaling of graphs in PDF The graph of the report is created dynamically depending on the following settings: • the alarm limits of the device • the highest and lowest measured value This is valid for all graphs in the PDF file until: • the highest and lowest measured values drop out of the history • the temperature settings are changed (self-configurable device only) Example below: The scale of the graph depends on the alarm limits set. The temperature scale ranges from +40°C to –5°C for the limits of +0.5°C and +28°C. Example below: The scale of the graph depends on the highest and lowest measured temperature values. The temperature scale ranges from –30°C to +60°C. Lowest measured temperature: –12°C, highest measured temperature: +25°C. Page 48 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.6. Temperature record duration (optional factory setting) Selectable record duration: 28, 56, 84, 112 days. Note: File names on the Fridge-tag are write protected. The names may only be changed after downloading the files onto a computer. Changing is either possible directly on unopened files or via open and save commands with Adobe Reader. Using other programs may cause loss of the digital signature. Date: Date of measurement Event: t Time/date changed Event: a Alarm configuration changed Event: hh:mm Time stamp: status checked Average temp. Average temperature Status: in progress The data collection “Today” is not yet complete Status: OK No alarm has been triggered in the past 30 days. (No alarm has yet been triggered since the data was read out on the device.*) Status: Alarm Alarm(s) have been triggered (With alarm symbol corresponding alarm have not been read out yet.*) Status: Alarm Alarm(s) have been triggered (Without alarm symbol means that the details of the corresponding alarm have already been read out on the device.*) Min. temp. Lowest recorded temperature Cum. duration Cumulative daily time below/above the limit means that the details of the Alarm Time at which the alarm was triggered trigger time Max. temp. Highest recorded temperature Duration Duration of an external sensor connection error *For more information go to chapter Alarm trigger function Page 49 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 12.7. Verification process This process verifies if the files (PDF and ASCII) created by the Fridge-tag are authentic and have not been manipulated or accidentally changed (meets the strict FDA 21 CFR Part 11 requirements). Note: Please ensure that the latest version of “JAVA Runtime” is previously installed on your computer. Step 1 Download the software Berlinger Verifier from our website: www.berlinger.com/verifier Step 2 Open the software. The following window will appear: Step 3 Click on “Open file” Step 4 Select the file you would like to verify. Option 1 Select the files directly from the Fridge-tag which is connected to your computer. Option 2 Select the files from the place where you saved them on your computer. When the file is correct and in its original condition, the following window will appear: In case the file has been changed, an error message will appear. Page 50 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 Proceed the same way with PDF and ASCII files. The same OK or error messages will appear. Page 51 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 13. Explanations of terms Readout mode: In order to avoid incorrect data, the Fridge-tag does not measure the temperature while settings are changed or during or Readout mode (e.g. changing time, date and during reading of history). The Fridgetag will fall back into normal operation after approx. 60 seconds without pressing any buttons. External sensor: After 10 minutes (factory setting) without connection between external sensor and device, two audio signals sound every three minutes for a maximum of 168 hours (7 days) and the entire display starts flashing. HI or LO indicator (external sensor): If the Fridge-tag measures temperatures above +0°C (+32°F) or below –95°C (-139°F), it shows HI or LO on the screen. The temperature will not be logged and not be shown in the PDF/ASCII file. The regular measurements and monitoring of alarm limits will continue as usual. As soon as the temperature is between +0°C (+32°F) and –95°C (-139°F) numbers will be displayed again. Page 52 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 14. Expire code explanation Sample: exp 2020-07 The sample shows the expiry date of the Fridge-tag as July 2020 (yyyy-mm). Page 53 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 15. Firmware Firmware: 4.0p0 Page 54 of 55 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 16. Glossary Glossary of Terms Abbreviation Title SOP Standard Operating Procedure Description Standard Operating Procedure (short SOP) is a binding textual description of the processes of procedures including the examination of results and their documentation. Glossary of Symbols Symbol Description OK symbol alarm symbol LOW alarm indicator HIGH alarm indicator warning symbol ! The warning box includes important informations or warnings. Page 55 of 55 ">

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Key features
- Ultra-low temperature monitoring (-95°C to +0°C)
- Audio and visual alarms
- Secure PDF reports
- USB connectivity
- Up to 3 years operating time
Frequently asked questions
To activate the device, simultaneously press and hold the SET and READ buttons for at least 3 seconds. The activation is complete when you see the message “Activation successful.” on the screen.
This model can be configured with pre-set alarm limits, which can be adjusted if the device supports self-programmable limits. The user manual provides detailed instructions on how to adjust these settings.
It is recommended to inspect both the device and the sensor regularly, ideally at least once per working day. This ensures they are functioning correctly and that there are no external issues affecting their measurements.