berlinger Fridge-tag Ultra Low User Manual
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berlinger Fridge-tag Ultra Low User Manual

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Summary of Contents for berlinger Fridge-tag Ultra Low

  • Page 2 User Manual Fridge- tag Ultra Low 1 — Last update: Dec 02, 2020 Berlinger & Co. AG Copyright © 2020 Berlinger & Co. AG...

  • Page 3: Table Of Contents

    Table of Contents 1. Home ..............................2 2. Important Information ........................3 3. Display explanations ......................... 7 4. State of delivery / sleep mode ......................8 5. Read out information prior to activation (in sleep mode) ............... 9 6. Placing the Fridge-tag ........................11 7.
  • Page 4 17. Glossary of Symbols ........................57...

  • Page 5: Home

    • 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...

  • Page 6: 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 Ultra Low may be required to carry out additional tasks for example: inspection, verification, signing, and archival.
  • Page 7 • 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.
  • Page 8 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.
  • Page 9 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.

  • Page 10: Display Explanations

    Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 11: State Of Delivery / Sleep Mode

    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 8 of 57...

  • Page 12: Read Out Information Prior To Activation (In Sleep Mode)

    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.
  • Page 13 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 14: Placing The Fridge-Tag

    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.

  • Page 15: Activation Process

    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.

  • Page 16: Activation Of The Device

    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.

  • Page 17: Setting The Calendar Format

    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.

  • Page 18: Using The Read And The Set Buttons

    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.

  • Page 19: Setting The Date

    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 appears as the first digit is digit.
  • Page 20 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 21: Setting The Time

    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”...
  • Page 22 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 23: Setting The Alarm Limits (Not Standard, Only If Preset By Factory)

    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.
  • Page 24 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 25 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.

  • Page 26: Connection Error (External Sensor Only)

    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).

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

    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...

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

    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.
  • Page 29 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.

  • Page 30: Screen Displays During Measurement Mode

    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 –...
  • Page 31 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 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.
  • Page 33 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.

  • Page 34: Alarm Display And Confirmation Options

    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 for 30 days.
  • Page 35 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 will be disabled for the corresponding alarms.
  • Page 36 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 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 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 device in the factory settings. Page 34 of 57...

  • Page 38: Cumulative Daily Time Above/Below The Limit

    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.

  • Page 39: Audio Alarm (Optional Factory Setting)

    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).

  • Page 40: Reading The History / Readout Mode

    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).

  • Page 41: Option 1: Read Out Day Per Day Directly On The Device (30-Day History)

    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: •...
  • Page 42 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...
  • Page 43 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) •...

  • Page 44: 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 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.
  • Page 45 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.) •...

  • Page 46: 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 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.
  • Page 47 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 48 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.

  • Page 49: Pdf Report Explanation

    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.
  • Page 50 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.
  • Page 51 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 52: Autoscaling Of Graphs In Pdf

    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: •...

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

    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.

  • Page 54: Verification Process

    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).
  • Page 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 52 of 57...

  • Page 56: Explanations Of Terms

    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 Fridge- tag will fall back into normal operation after approx.

  • Page 57: Expire Code Explanation

    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 54 of 57...

  • Page 58: Firmware

    Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 15. Firmware Firmware: 3.4p0 Page 55 of 57...

  • Page 59: Glossary

    Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 16. Glossary Abbreviation Title Description configuration PCb number upper alarm limit lower alarm limit 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.
  • Page 60 Berlinger & Co. AG User Manual Fridge-tag Ultra Low - 1 17. Glossary of Symbols Symbol Title Description OK symbol alarm symbol HIGH alarm indicator LOW alarm indicator warning symbol The warning box includes important informations or warnings. Page 57 of 57...

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