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berlinger Fridge-tag 2 L User Manual

Fridge-tag 2 l
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Natalie Wells
March 13, 2025

Hello, we have a few of your Fridge-tag 2L temp loggers and need to get a replacement copy of the calibration document that comes packaged with the device. I do not know if you are able to provide us that documentation, but if so here are the following device serial numbers that we will need calibration documentation for. Serial # 130500120199 and Serial # 160500069415. We do clinical research and one of our sponsors is asking for this documentation before they allow us to use the temp loggers. Thank you.

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Summary of Contents for berlinger Fridge-tag 2 L

  • Page 2 User Manual Fridge- tag 2 L 1 — Last update: Apr 20, 2021 Berlinger & Co. AG Copyright © 2021 Berlinger & Co. AG...

  • Page 3: Table Of Contents

    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.

  • Page 4: Home

    Berlinger Fridge-tag 2 L Proven quality combined with new features A powerful and competitive novelty is the audible alarm signal. The Fridge-tag 2 L automatically triggers an alarm, if a critical temperature deviation out of the predefined temperature range will be measured.

  • Page 5: Important Information

    (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 2 L may be required to carry out additional tasks for example: inspection, verification, signing, and archival. The Fridge-tag 2 L 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.
  • Page 6 • 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.
  • Page 7 User Manual Fridge-tag 2 L - 1 Battery The Fridge-tag 2 L contains a coin cell Lithium battery. Please, pay strict attention to the following points: • The housing of the Fridge-tag 2 L must never be opened nor destroyed.
  • Page 8 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 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.

  • Page 9: Display Explanations

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 3. Display explanations (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.

  • Page 10: State Of Delivery / Sleep Mode

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 4. State of delivery / sleep mode The Fridge-tag is shipped in sleep mode. The display (LCD) is blank. Page 7 of 56...

  • Page 11: Read Out Information Prior To Activation (In Sleep Mode)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.
  • Page 12 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 After 8th pressing of PCb number READ (manufacturer information) Battery power: 3 bars = full (>70%) After 9th pressing of 2 bars = half-full (>30–70%) READ 1 bar = low (0–30%)** **Device should be replaced.

  • Page 13: Placing The Fridge-Tag

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 6. Placing the Fridge-tag Placing the Fridge-tag with an internal sensor The activated Fridge-tag must be placed immediately after activation in its predetermined location. It is recommended and important to place the device in the center of the refrigerator for an optimal temperature observation.

  • Page 14: Activation Process

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 15: Activation Of The Device

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 16: Setting The Calendar Format

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 17: Using The Read And The Set Buttons

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 18: Setting The Date

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 appears as the first digit is digit.
  • Page 19 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 1. Press READ until “2” appears as the fourth digit. The 4th digit is 2. Press SET to save. flashing. Note: The fifth and the sixth digit are set automatically.

  • Page 20: Setting The Time

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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”...
  • Page 21 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 1. Press READ until “4” The 3rd appears as the third digit is digit. flashing. 2. Press SET to save. 1. Press READ until “7” The 4th appears as the digit is fourth digit.

  • Page 22: Setting The Alarm Limits (Not Standard, Only If Preset By Factory)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.
  • Page 23 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 1. Press READ to adjust the number. The 3rd digit of the duration of the alarm 2. Press limit is flashing. SET to confirm number. 1. Press READ to adjust the number.
  • Page 24 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 sensor) or 0°C/0°F and +55°C/+131°F (external sensor) 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.
  • Page 25 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 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.

  • Page 26: Connection Error (External Sensor Only)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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).

  • Page 27: Read And Change Settings / How To Correct Setting Mistakes

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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...

  • Page 28: Initial Menu (Read And Change Settings)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.
  • Page 29 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 30: Screen Displays During Measurement Mode

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 –...
  • Page 31 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 • (OK symbol) will be replaced by (alarm symbol) • An additional alarm indicator will be indicated in the upper display area to show which alarm limit has been exceed and on which day.

  • Page 32: Alarm Trigger Function

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.
  • Page 33 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 34: Alarm Display And Confirmation Options

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 for 30 days.
  • Page 35 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 will be disabled for the corresponding alarms.
  • Page 36 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 1. Alarm triggered: alarm symbol and warning symbol on display 2. Alarm confirmed within the set temperature limits: (OK symbol) on display 3. Alarm triggered: alarm symbol and warning symbol on display.

  • Page 37: Cumulative Daily Time Above/Below The Limit

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 38: Audio Alarm (Optional Factory Setting)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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).

  • Page 39: Reading The History / Readout Mode

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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).

  • Page 40: Option 1: Read Out Day Per Day Directly On The Device (30-Day History)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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: •...
  • Page 41 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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...
  • Page 42 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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) •...

  • Page 43: Option 2: Read Out Alarms Directly On The Device - Use The Alarm Super Jump Function (30-Day History)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.
  • Page 44 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.) •...

  • Page 45: Option 3: Read Out Data From The Files Generated By The Fridge-Tag By Connecting It With A Computer

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.
  • Page 46 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 47 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 48: Pdf Report Explanation

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 12.4. PDF report explanation Sample of a PDF file generated by a Fridge-tag 2 L with external sensor (page 1/2) 1. Document title and device type 2. Device ID and further information 3.
  • Page 49 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 Sample of a PDF file generated by a Fridge-tag 2 L with external sensor (page 2/2) 1. Each graph shows data from a period of 7 days 2. Incrementally numbered graphs 3.
  • Page 50 Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 51: Autoscaling Of Graphs In Pdf

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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: •...
  • Page 52 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 Sample of a PDF file generated by a Fridge-tag with internal sensor Page 49 of 56...

  • Page 53: Temperature Record Duration (Optional Factory Setting)

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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.

  • Page 54: Verification Process

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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).
  • Page 55 Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 Proceed the same way with PDF and ASCII files. The same OK or error messages will appear. Page 52 of 56...

  • Page 56: Explanations Of Terms

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 Fridge- tag will fall back into normal operation after approx.

  • Page 57: Expire Code Explanation

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 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 54 of 56...

  • Page 58: Firmware

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 15. Firmware Firmware: 4.0p0 Page 55 of 56...

  • Page 59: Glossary

    Berlinger & Co. AG User Manual Fridge-tag 2 L - 1 16. Glossary Glossary of Terms Abbreviation Title Description Standard Standard Operating Procedure (short SOP) is a binding textual description of Operating the processes of procedures including the examination of results and their Procedure documentation.

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