Data Logger Protocol
Data Logger Protocol
Temperature Monitoring
Fridge-tag®2/Data Logger
Protocol for Continuous Temperature Monitoring 2
Contents
I. Background…………………………………………………………………………….. 3
II. Purpose…………………………………………………………………………………. 4
III. Equipment/Fridge-tag®2………………………………………………………………. 4
IV. Placement of the Fridge-tag®2………………………………………………………. 5
V. Pre-set Alarm Parameters…………………………………………………………….. 5
VI. Display Explanations………………………………………………………………….. 6
VII. Initiating the Fridge-tag®2……………………………………………………………. 7
A. Display Test……………………………………………………………………... 7
B. Device Activation………………………………………………………………. 9
C. Setting the Calendar Format………………………………………………….. 10
D. Instructions for Using the READ and SET Buttons…………………………. 11
E. Setting the Date………………………………………………………………… 12
F. Setting the Time………………………………………………………………… 15
G. Setting the Temperature Measurement Unit………………………………… 16
H. LOC Function…………………………………………………………………… 17
I. CHANGE mode in Fridge-tag®2……………………………………………… 18
i. Change from °C to °F………………………………………………… 19
ii. Change Date and/or Time…………………………………………… 19
J. Display Indication- OK/ALARM……………………………………………….. 20
i. Example of OK (√) Display……………………………………………. 21
ii. Example of (X) ALARM………………………………………………… 21
VIII. Reading the Temperature History……………………………………………………. 22
A. Option 1: Day to Day Overview……………………………………………….. 22
B. Option 2: Alarm Read Out Only………………………………………………. 25
C. Option 3: Downloading Data/ Generating a Report………………………… 26
Sample PDF Report……………………………………………………. 27
Explanation of PDF Report……………………………………………. 28
IX. Protocol for Downloading and Reporting Temperature Data………………………. 29
X. Explanation of Terms…………………………………………………………........ 30
Battery Specifications and 30
Care………………………………………………………………………………………
XII. Life of Device………………………………………………………………………….. 31
I. Background:
The Centers for Disease Control and Prevention (CDC) has developed interim guidance for the
proper storage and handling of vaccine. These recommendations include the use of continuous
temperature monitoring devices, or digital data loggers, for all vaccine storage units (refrigerators
and freezers).
The data logger should provide a digital display of the internal storage unit temperature including
min/max temperatures and current temperature. Data loggers are preferred over other types of
thermometers as they can provide an indication of the length of time a storage unit has been
operating outside the recommended vaccine storage temperature range, whenever a temperature
excursion occurs.
Continuous monitoring refers to the thermometer’s ability to track and record temperatures over
time. Unlike a simple min/max thermometer, which provides only information about the warmest
and coldest temperature that was reached; the continuous monitoring device provides detailed
information on temperatures recorded at pre-set intervals. Digital data loggers work by storing
continuous temperature data in the devices memory. This stored data then can be downloaded to a
PC or Mac for review and archive.
II. Purpose:
In an effort to meet CDC requirements, the Alabama Vaccines for Children (VFC) Program is now
using the Fridge-Tag® 2 manufactured by Berlinger & Co. AG.. Berlinger developed a product in
this device that specifically meets the needs of public and private healthcare providers who are
managing vaccine supplies, making the transition to continuous temperature monitoring simple
and reliable.
The intention of this manual is to provide guidelines for implementing the use of the Fridge-tag® 2
in accordance with VFC Program specifications, as well as to provide detailed instruction for
operating the device, originated by Berlinger & Co. AG.
III. Equipment:
The Fridge-tag® 2 digital data logger produces a 60 day report that can be printed, emailed and
stored. It comes with an NIST traceable certificate of accuracy. Simply detach it from the external
probe, connect it to any computer via USB, and download the report like a removable memory stick.
Software is not needed. Fridge-tag® 2 reports are 21 CFR Part 11 compliant to meet FDA and CDC
requirements.
The Fridge-tag® 2 tracks temperatures minute per minute. This allows for continuous temperature
monitoring of the vaccine storage unit. The Fridge-tag® 2 has been calibrated and ISO 17025
certified for a period of 2 years.
The Fridge-tag® 2
The Fridge-tag® 2 is equipped with a display monitor and a bio-safe glycol filled vial (buffered probe) and
connecting cable.
The Fridge-tag® 2 display monitor should be positioned outside the vaccine storage unit. The bio-safe
glycol filled bottle/probe should be centrally place inside the storage unit along with the vaccine supply
away from ceilings, walls, vents, fans and coils.
1. Place the glycol filled vial inside the storage unit (It is recommended to do this 30 minutes prior
to device activation to allow it to acclimate and prevent erroneous temperature readings upon
initiation of the device).
2. Pass the connecting cable through the back hinge of the
storage unit door (gap between the door and unit when
opened). **(Important tip: Secure the cable against the
interior wall with duct tape prior to the wire’s exit to the
outside monitor. This will keep it secure inside the storage
unit and prevent the vial from moving when disconnecting
the device for report downloading.)
3. Affix the Fridge-tag®2 display monitor to the outside door or
side of storage unit with the magnet provided. (**Again using duct tape to tape the cable in
place on the storage unit door.)
The display monitor shows the temperature measured by the bio-safe glycol filled vial/probe with an
External sensor.
o Note: After disconnecting the display monitor when downloading temperature data, be sure to re-
connect the appropriate device with pre-set alarm parameters to the correct unit, either refrigerator or
freezer.
Your Fridge-tag® 2 device(s) are pre-set to monitor either your refrigerated vaccine storage unit
(refrigerator) temperatures or your frozen vaccine storage unit (freezer) temperatures in degrees
centigrade:
i.
ii.
iii.
iv. Display Explanations
Protocol for Continuous Temperature Monitoring 7
A. Display test
1. Press the READ button: All segments are activated.
2. Press READ a second time: Indication of date and production test result will appear
Example: (16. September 2012/PASS)
Protocol for Continuous Temperature Monitoring 8
3. Press read a third time: Indication of the current temperature and activation of sensor
5. Press read a 5th time: Indication of 1st alarm settings and Alarm type: Time and temperature
limits (example shows: >+8.0°C, 10 hours, High)
6. Press read a 6th time: Indication of the 2nd alarm settings and Alarm type: Time and
temperature limits (example shows: <-0.5°C, 60 minutes., Low)
Protocol for Continuous Temperature Monitoring 9
B. Device Activation
1. Press the SET and READ buttons simultaneously for more than 3 seconds.
The READ button is used to adjust the number. 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.
The SET button is used to save the number. After pressing the SET button the next digit will start
flashing.
Protocol for Continuous Temperature Monitoring 12
The following example shows how to set the date to: 16th of Sept. 2012 (16.09.2012)
After setting the date, the first digit of the time will start flashing.
Protocol for Continuous Temperature Monitoring 15
1. Press READ seven times until “7” appears as the fourth digit
2. Press SET to save
After finishing the time setting the “°C” symbol will appear at the right bottom corner.
The activation is now completed and on the display the word “LOC” appears.
H. LOC function
For a period of 10 minutes the Fridge-tag 2 does not measure the temperature when the following
actions take place:
After the actions have been completed the sign “LOC” appears on the screen. This function
prevents recordings of false data which could be caused by heat while holding the device in the
hang and it allows an adaption to the environmental temperature before normal recording
continues.
Overview
If you are reading the HISTORY you cannot enter CHANGE mode. You must be in CURRENT
STATUS mode to enter into CHANGE mode. Pressing SET will change from HISTORY to
CURRENT STATUS mode.
Decide which function you want to change. If you want to change more than one functional area
you must do that separately by accessing the change mode twice. The functions work much like
setting a digital watch where one button scrolls through the options and the other selects the desired
display.
BUTTON FUNCTIONS
READ=CHANGE
SET= ACCEPT WHAT I SEE ON SCREEN AND GO ON TO THE NEXT STEP
Note:
• Time and date adjustments have no effect on the alarm recording.
• The time does not change automatically with daylight savings time (please see steps for
entering change mode above)
• Adjustments can only be made for date and time settings and for changing the temperature
measurement unit.
• Once the device is activated, it cannot be stopped anymore.
• The number of time adjustments during the same day is unlimited. After the adjustment has
been done, the Fridge-tag 2 will be locked for 24 hours from the following midnight (e.g.
changes on the 15th of Sept., device locked from 00:01 am on the 16th until 00:01 am on the
17th). This is for security reasons.
Protocol for Continuous Temperature Monitoring 19
Access CHANGE mode by pressing SET button quickly (this assures you are in CURRENT
STATUS (you do not want to be in HISTORY or CHANGE mode).
1. While holding the SET button press the READ button and release both buttons quickly and
simultaneously.
Access CHANGE mode by pressing SET button quickly (this assures you are in CURRENT
STATUS (you do not want to be in HISTORY mode or CHANGE mode.
1. While holding SET button press the READ button, then release both buttons quickly and
simultaneously. You should see OUT SIdE on the display
2. Press READ see Set dAtE on the display
3. Press SET see date format flashing
4. Press SET 7 times to set date and access the time format
5. Press SET if the 10+hours is correct or READ to change through options (0-9) and press SET
when the desired number is displayed
6. Press SET if the minutes are correct or READ to change through the options (0-9) and press
SET when the desired number is displayed.
7. The device will return to CURRENT STATUS.
Protocol for Continuous Temperature Monitoring 20
J. Display Indication-OK/ALARM
• 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® 2 will also indicate that
the measuring is made with an External sensor.
• A (√) OK symbol is indicated during normal operation as long as not alarms have been
recorded. The temperature and time conditions were within the pre-set alarm parameters.
Protocol for Continuous Temperature Monitoring 21
If the temperature and time conditions are outside the pre-set alarm parameters the following will be
displayed on the screen:
3. In addition to the (X) (ALARM symbol) the warning symbol (!) will appear beside the (X)
Note: the warning symbol will remain visible until the user reads the details of the triggered
alarm(s). After that it will disappear.
4. Alarm indications cannot be cancelled or reset. The (X) will remain on the device for 30 days
following the occurrence of the last alarm.
Protocol for Continuous Temperature Monitoring 22
Option 1: Read out day to day directly on the device (30 day overview)
Option 2: Read out Alarms only, directly on the device with the ALARM SUPER JUMP
function (30 day overview)
Option 3: Read out the data from the PDF/A* and ASCII document generated via USB
interface (60 day overview) (Downloading Data: Generating a Report)
Option 1: Read out day to day directly on the device (30 day overview)
IMAGE
• The OK symbol
• The corresponding arrow (example high (▲)arrow of today)
• Highest Recorded temperature (example: +10.5°C)
• The time duration out of the preset temperature high limit (example: 00:32; hrs:min)
Protocol for Continuous Temperature Monitoring 23
• The OK symbol
• The corresponding arrow (example: low arrow (▼) of today).
• Lowest recorded temperature (example: +2.9°C)
• The time duration out of the preset temperature low limit (example 00:00;hrs:min).
*Continue to repetitively press the READ button to read out the details of the past 30 days.
*When you reach an ALARM event, the indication on the screen of the Fridge-tag® 2 will be
different to the indication of an OK display.
Protocol for Continuous Temperature Monitoring 24
Example of an ALARM display-during read out of the history 1st displayed screen of a “lower
ALARM event”
Option 2: Read out Alarms only, directly on the device with the ALARM-SUPER-JUMP
function (30 day history)
If you like to read out only the ALARMS directly on the device, press and hold the READ button for
at least 3 seconds.
Information:
Press and hold the READ button again for at least 3 seconds and the next Alarm event will
appear on the screen.
1. Detach the wire from the port on the side of the Fridge-tag 2 external monitor
2. Gently pull out the USB wire on top of the device and plug it in to the USB port on your
desk top or lap top computer.
3. Open “My Computer” from the Start Menu to access the Fridge-tag 2 drive and double
click on the icon to view the files (PDF and ASCII/text).
4. Click on the PDF file to open the report.
5. Save downloaded data to your computer for archive, print, and/or email to the VVFC
Program Manager for review.
6. Rename each file with the date of download for easy reference.
7. Maintain a file of all downloaded temperature reports for a period of 3 years.
Protocol for Continuous Temperature Monitoring 27
Protocol for Continuous Temperature Monitoring 28
2. READ your temperature data on the data logger as often as possible but at a very minimum of twice daily during
operating business hours. It is important that you check and record the temperatures of both the refrigerator
and freezer units at the beginning and end of each workday. If there is an alarm on your device, READ out
the temperature history immediately to determine the duration and extent of the temperature excursion.
Immediate corrective action can then be taken as necessary. It is vital that appropriate action is taken
to rectify the cause of the temperature excursion and preserve vaccine viability.
3. The logger will have 30 days of data for review from the display; the PDF report contains 60 day’s data. You’ll
want to keep a printed monthly log with your twice daily temp logs. (Saving the PDF files monthly as an
electronic back-up would serve as a ‘best-practice’). Be sure to use the “save as” option and give each file a
unique name. (e.g., JulyRefrigeratorTemps.pdf).
*Important: It is highly recommended if you have more than one data logger, that each device be labeled (with a
sharpie or other permanent method) which device is dedicated to each storage unit.
Protocol for Continuous Temperature Monitoring 30
X. Explanation of Terms:
More information about the Fridge-tag® 2 can be found in the sales brochure and the
website www.berlinger.com
Technical specifications
Storage condition (inactive) -30°C to +60°C
Operating Temperature -30°C to +55°C
Display visible -10°C to +55°C
Accuracy of temperature measurement +/- 0.5°C (-5°C to +30°C) +/- 0.6°C (beyond
this range)
Accuracy of time measurement +/- 30 minutes/year
Temperature measurement interval Every minute
Operating lifetime Up to 3 ½ years following manufacture date
Protection class IP67
The devices can be used up to 3 ½ years after production date with respect to the following conditions:
The buttons are not pressed for a very long time, e.g. if jammed between the items in storage
Storage and operation of the device remains inside the recommendations of the manufacturer,
especially very low temperatures should be avoided.
The end of the battery life is indicated by the low battery indicator on the display. Please make sure
to replace devices with activated low battery indicator within 20 days. Accuracy and proper function of
the device cannot be assured beyond this period.
Appendix 1
Protocol for Continuous Temperature Monitoring 33
Additional Resources:
http://www.berlinger.ch/en/berlinger/main/ambient-tag/downloads/fridge-tagr-2.html
http://www.cdc.gov/vaccines/recs/storage/toolkit/default.htm
http://www.cdc.gov/vaccines/recs/storage/guide/default.htm
http://www.immunize.org/catg.d/p3051.pdf
• IAC has created temperature recording logs and a troubleshooting record: “Vaccine Storage Troubleshooting
Record” to document unacceptable vaccine storage events. These materials provide guidance on the
appropriate steps to take in the event of a storage problem (see www.immunize.org/handouts/vaccine-storage-
handling.asp
• http://www.berlingerusa.com/fridgetag2/supportvideos/
o Video 4: How to read Fridge-tag® 2 screen, daily min/max temperatures and track reading activity