Step-by-step interpretation of 10-day electronic temperature monitoring devices for international vaccine shipments

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Ruby Quinn
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1 Step-by-step interpretation of 10-day electronic temperature monitoring devices for international vaccine shipments

2 What information old guidelines provide? 2000 guidelines Inclusion of 1 CCM and 1 freeze indicator in each box Activated devices indicate that there was a problem that's all. But when, where and to what extend were unknown.

3 What is new with the electronic devices? 2005 guidelines Inclusion of one 10-day temperature monitoring device in each box (except one CCM for shipments with dry ice) Detailed information answering questions: At what hour the violation(s) has had happened? To what extend? What were the highest and lowest temperature exposure during the violation?

4 What is new with the electronic devices? Type II device with BLUE backing card For OPV and freeze-dried BCG, measles, MR, MMR, lyophilized Hib, yellow fever and meningitis vaccines with the following temperature alarm settings: Temperature Alarm type Period for triggering the alarm 45 o C single event 1 hour 30 o C cumulative 10 hours 10 o C cumulative 20 hours Type I device with YELLOW backing card For DTP, DT, TT, Td, HepB, IPV, liquid Hib and combination vaccines with the following temperature alarm settings: Temperature Alarm type Period for triggering the alarm 45 o C single event 1 hour 30 o C cumulative 10 hours -0.5 o C single event 1 hour

5 What is new with the electronic devices? WHEN At 11 hours 20 minutes (following activation of the device at the vaccine manufacturer's facility, the lower alarm has activated. TO WHAT EXTENT Lowest temperature recorded during this violation was -4.2 o C

6 Three devices listed in the PIS Q-tag 2 plus Spytemp II OMS 3M TX Open ALL boxes, check that devices are running

7 Steps to be followed 1. Open ALL boxes 2. Check that devices are running 3. Stop the device 4. Write down the time you stopped the device on the backing card 5. Read the status (OK / ALARM) 6. If ALARM, go to HISTORY mode and read the details 7. Make a photocopy or scan the device to document the ALARM status. In each image, indicate the number of the box that the device was in. 8. Include all necessary information in the Vaccine Arrival Report (VAR). 9. If there are any ALARMS, fill in the Alarm Reporting Form and attach it to the VAR. 10. Send the VAR with photocopies or printed images from scanned devices and the Alarm Reporting Form to the "procurement agency".

8 Q-tag 2 plus WHO/PIS/E06/55 Parts of the device OK and ALARM status display Display Limit indicators Programmed temperature limits Time setting of the particular segment Time and temperature display STOP button Unique identification number with bar code Logo START button Transport time

9 Q-tag 2 plus WHO/PIS/E06/55 Parts of the device First alarm (left position) Limit indicator ( ) on the LEFT position (first alarm) Next (right position) Additional arrows pointing to the middle of the circle indicate alarm occurring during this particular 10-hour period. Total duration of journey (86 hours 27 minutes) Device is stopped Limit indicator ( ) on the RIGHT position (next alarm) Displaying ALARM status

10 Q-tag 2 plus WHO/PIS/E06/55 Elapsed transport time Eight segments are highlighted OK status displayed for elapsed transport time of 83 hours and 53 minutes.

11 Q-tag 2 plus WHO/PIS/E06/55 Arrows inside the circle indicate the time segment in which an alarm has occurred. happened. Limit indicator ( ) on the LEFT position (first alarm) Limit indicator ( ) on the RIGHT position (next alarm)

12 Q-tag 2 plus WHO/PIS/E06/55 Note that each shipping carton contains an electronic device, so you must open ALL boxes. Remove the Q-tag 2 plus from the carton and press the STOP button for three seconds. The run sign will disappear from the bottom right corner of the screen and the stop sign will appear on the bottom left corner of the screen. Check the screen. If an OK sign is displayed, it means there were no temperature violations during the shipment. The number of dark segment marks indicates the total transport time. In this example, the shipment took at least 120 hours (12 dark segments are highlighted). Precise elapsed transport time displayed in the middle of the circle is 127 hours 41 minutes.

Q-tag 2 plus WHO/PIS/E06/55 Limit indicator ( ) on the left position indicates the first alarm. In this example, the first alarm is a violation of - 0.5 o C limit for more than one hour.

13 Q-tag 2 plus WHO/PIS/E06/55 Limit indicator ( ) on the left position indicates the first alarm. In this example, the first alarm is a violation of o C limit for more than one hour. This alarm occurred between 10 and 20 hours (corresponding to the second time segment after the activation of the device). If an ALARM sign is displayed, that shows temperature limits were violated during the shipment. Additional arrows pointing to the centre of the circle indicate the time periods in which alarms have occurred. If there are more limit indicators ( ) on the right position, this indicates additional alarms (second, third or fourth). Details can only be obtained in HISTORY mode.

14 Q-tag 2 plus WHO/PIS/E06/55 All stored data can be retrieved for six months after stopping the Q-tag 2 plus. The device must be set in the HISTORY mode. You activate this mode as follows. *Press START button firmly. *Simultaneously press STOP button for one second. *Release both buttons. As soon as HISTORY mode is activated, the first time segment and the max sign start flashing. Additionally, a temperature is displayed in the LCD centre. This is the highest recorded temperature during the first time segment.

15 Q-tag 2 plus WHO/PIS/E06/55 With the next push to START the max sign disappears and min sign flashes. First time segment continues flashing. The temperature displayed in the LCD centre is the recorded minimum during the blinking time segment.

16 Q-tag 2 plus WHO/PIS/E06/55 Alarm details (HISTORY mode) If alarms have been recorded, they will be indicated by arrows inside the segment circle. The alarm details are also visible in the HISTORY mode. In a segment with alarms, the maximum, minimum and mean temperatures are displayed as formerly described by repeatedly pressing the START button (maximum max, minimum min, and mean value max + min ). If there is an alarm, when pressing the START button for the fourth time, the ALARM sign appears in the middle of the screen. Above the ALARM sign, time display indicating the elapsed time between the start of measurements and the alarm event appears. In this example, at 11 hours 20 minutes -0.5 o C alarm was triggered for more than one hour. symbol in the left display region indicates the alarm type as printed on the label.

17 Q-tag 2 plus WHO/PIS/E06/55 The next push to the START button gives details of the temperature recorded during the violation. For 10oC, 30oC, and 45oC alarms it displays the highest temperature recorded during the violation and this is indicated by the max sign flashing. For a -0.5oC alarm, it displays the lowest temperature recorded during the violation and the min sign starts flashing. In this example the lower alarm is triggered. The lowest (minimum) temperature recorded during the violation was -4.2 o C. Since this alarm involves low temperatures, the min sign is flashing indicating that the temperature displayed is the minimum temperature recorded.

18 Q-tag 2 plus WHO/PIS/E06/55 symbol in the left display region indicates the alarm type as printed on the label. In this example, at 67 hours 32 minutes, the 30 o C alarm was triggered for more than 10 hours. Since this alarm involves high temperatures, the max sign is flashing indicating that the temperature displayed is the maximum temperature recorded. With the next push to the START button, the screen in the middle displays the highest (maximum) temperature recorded during the violation which was 34.7 o C.

19 Q-tag 2 plus WHO/PIS/E06/55 How can Q-tag 2 plus be tested? (TEST mode) 10 times All display segments are shown Current ambient temperature

20 Spytemp II OMS WHO/PIS/E06/52 Parts of the device A bar cursor at the top of the screen indicates the elapsed transport time. Each side of the symbol corresponds to 6 hours of transport time. Logo Indicators ( ) for ALARM and/or OK status ON indicator showing the device is running. Programmed temperature limits Control buttons for starting and stopping the device and viewing the history mode. OK status indicator Type of device (Type 2 corresponds to OPV and freeze-dried vaccine presentations with BLUE backing card).

21 Spytemp II OMS WHO/PIS/E06/52 Parts of the device symbol indicating a temperature violation, exceeding 45 o C preset limit. Time and temperature display in HISTORY mode.

When stopped symbol pointing to ON at the bottom left corner of the screen should disappear.

22 Spytemp II OMS WHO/PIS/E06/52 Remove the Spytemp II OMS from the carton and press the buttons 1 and 2 simultaneously for three seconds. When stopped symbol pointing to ON at the bottom left corner of the screen should disappear. Note that each shipping carton contains an electronic device, so you must open ALL boxes. Check the screen. If symbol is pointing to OK, that means there were no temperature violations during the shipment.

23 Spytemp II OMS WHO/PIS/E06/52 A rectangle is shown for each day, and one segment for every six hours. In this example, elapsed transport time was 1 day and 12 hours. If one or more symbols are pointing to any of the programmed temperature limits, this means that temperature violations have occurred. In this example, the 30 o C alarm is marked with the symbol.

Spytemp II OMS WHO/PIS/E06/52 In order to activate the HISTORY mode to access details of the alarms, press button 1. Detail of the first alarm will appear on the screen.

24 Spytemp II OMS WHO/PIS/E06/52 In order to activate the HISTORY mode to access details of the alarms, press button 1. Detail of the first alarm will appear on the screen. In this example, at 40 hours 20 minutes, a 10 o C violation accumulating more than 10 hours was commenced. Type of alarm is indicated by a symbol. This indicates that the highest temperature recorded during the violation was 15.5 o C.

25 Spytemp II OMS WHO/PIS/E06/52 When you press button 1 once more, the screen shows the details of a second alarm, if any. In this example, at 62 hours 40 minutes a second alarm was triggered with temperature exposure to above 45 o C for more than one hour (continuously). Type of alarm is indicated by a symbol. This indicates that the highest temperature recorded during the violation was 45.5 o C.

26 Spytemp II OMS WHO/PIS/E06/52 If the -0.5oC temperature limit is violated, the HISTORY mode will indicate the lowest temperature recorded during the violation. This indicates that the lowest temperature recorded during the violation was -5.5 o C. In this example, at 22 hours 10 minutes a -0.5 o C alarm condition for more than one hour was commenced. Type of alarm is indicated by a symbol.

27 Spytemp II OMS WHO/PIS/E06/52 Spytemp II OMS device is programmed to record temperatures at 10-minute intervals. It allows users to see details of every single recording. In order to read details of every recording in 10-minute intervals, press button 2 repeatedly to go through the log. This example shows that the very first recording at the tenth minute was 5.5 o C. During the HISTORY mode, press button 1 to view the previous recorded time and temperature. Pressing button 2 shows the next recorded time and temperature. In this example, if button 2 is pressed, 00 hours 20 minutes recording will be indicated.

28 3M TX01 and TX02 WHO/PIS/E06/54 Parts of the device Calendar symbol. Next two digits indicate number of days. Display Logo START button Scroll up/down arrows to get details of each alarm violation. min, max temp.; time } Programmed temperature limits STOP button CLOCK symbol. Next four digits indicate hours and minutes. Twin bar code label Unique serial number with bar code

3M TX01 and TX02 WHO/PIS/E06/54 Parts of the device Minus symbol Min / Max temperatures Temperature shown Battery status No. of days No. of hrs: min (at delay mode only min : sec.).

29 3M TX01 and TX02 WHO/PIS/E06/54 Parts of the device Minus symbol Min / Max temperatures Temperature shown Battery status No. of days No. of hrs: min (at delay mode only min : sec.). } Alarm types incl. order of alarm violation (1=first; 2=second; 3=third). violation Total run time since START OK or Not OK indicator Device stopped Early warning Device is running. Unit is still in the "1hr delay mode".

30 3M TX01 and TX02 WHO/PIS/E06/54 Note that each shipping carton contains an electronic device, so you must open ALL boxes. Press the STOP button to stop the logging process; symbol indicating running status will disappear and the STOP symbol is displayed in the bottom right corner of the display. Once stopped, the current actual temperature and the logging time will be displayed on the screen.

31 3M TX01 and TX02 WHO/PIS/E06/54 This logger has stopped after 6 days, 19 hours and 25 minutes logging time (total elapsed time). The temperature was 8.7 o C at the time it was stopped. Check the shipment result by looking at the OK or Not OK symbol at the bottom left corner of the display. If there was no violation of any limit set, the OK symbol will be seen in the bottom left corner No alarm occurred. OK sign is displayed.

32 3M TX01 and TX02 WHO/PIS/E06/54 Numbers on the right side of the screen indicate the alarms triggered. The first alarm is indicated with 1, while the second alarm is indicated with 2 and the third alarm with 3. In this example two alarms have been triggered. The first one (1) >= 30 C for 10 hours cumulative and the second (2) <= -0.5 C for a minimum of one hour single exposure. Crossed-out OK symbol indicates temperature violations during the shipment.

33 3M TX01 and TX02 WHO/PIS/E06/54 Use UP and DOWN arrow buttons to get detailed information of each violation. When you press the DOWN button arrow once, the symbol appears next to the top limit (>= 45 o C - 1 hr). If there is no alarm for this limit, date and time indicators will be indicated as 0 (zero).

34 3M TX01 and TX02 WHO/PIS/E06/54 The maximum temperature recorded during this violation was 38.1 o C When you press the DOWN button arrow for the second time, symbol moves to the next set limit (>= 30 o C 10 hr). In this example, the alarm has occurred 2 days, 11 hours and 34 minutes after the start.

35 3M TX01 and TX02 WHO/PIS/E06/54 When you press the DOWN button arrow for the third time, symbol moves to the next set limit (<= -0.5 o C - 1 hr). In this example, this alarm has occurred 7 days, 9 hours and 35 minutes after the start. The lowest (minimum) temperature recorded was -4.1 o C.

36 3M TX01 and TX02 WHO/PIS/E06/54 Use the UP/DOWN arrow buttons to move the symbol to the position Time after start. Time after start indicates the number of days, hours and minutes passed since the logger was started, even after it was stopped. The timer counts up to 99 days, 23 hours and 59 minutes, and then stops. The example below shows a device that is checked 22 days, 4 hours and 15 minutes after it was started. This feature helps staff to indicate the violations in real time. The timer shows that the logger was started 22 days, 4 hours and 15 minutes ago.

37 3M TX01 and TX02 WHO/PIS/E06/54 Early warning The early warning indicator is activated once 50% of an alarm condition has been reached (e.g. if the temperature was below -0.5 C for more than 30 minutes). The early warning can be seen by moving the symbol to the early warning position, using the UP/DOWN arrow buttons. This logger shows the details of the first early warning: the 50% condition for the -0.5 C for one-hour alarm was reached after 2 days, 12 hours and 22 minutes. The minimum recorded temperature (supported by the min sign at the top left corner of the screen) during this period was -1.5 C.

38 3M TX01 and TX02 WHO/PIS/E06/54 If there is another early warning in the same OK status shipment, when pressing the DOWN button once more the number 2 will appear next to one of the set limits. This logger shows the details of the second early warning: the 50% condition for the >=45 C for one-hour alarm was reached after 5 days, 3 hours and 12 minutes. The maximum recorded temperature (supported by the max sign at the top centre position of the screen) during this period was 48.0 C.

39 3M TX01 and TX02 WHO/PIS/E06/54 An early warning with a failed (Not OK) shipment This logger shows the details of the first early warning: the 50% condition for the >=30 C for 10 hour cumulative alarm was reached after 1 day, 22 hours and 35 minutes. The maximum recorded temperature (supported by the max sign at the top centre position of the screen) during this period was 37.9 C.

40 3M TX01 and TX02 WHO/PIS/E06/54 This logger shows that the shipment did not even indicate an Early warning. This shipment was absolutely OK.

Heart icon. Model designation Run icon. Low battery icon Start/Stop button

Heart icon. Model designation Run icon. Low battery icon Start/Stop button The figure below illustrates the VaxAlert indicator with all screen icons simultaneously displayed, along with supporting and navigational information on the product label. This display image is not representative