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

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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 of the device in the use environment. (See following sections for additional information) VaxAlert Display and Operation Features: Product logo Start delay icon = no alarm(s) Heart icon Alarm excursion event counter Model designation Elapsed time display (D, H, M) Up/down scroll buttons Alarm conditions Low battery icon Start/Stop button Unique identification number and barcode (on side) Temperature reading display Alarm indicator(s) to each triggered alarm Temperature sensor

Step-by-step user guide for the VaxAlert Starting the VaxAlert: 1. Prior to starting the VaxAlert, the display will present a blinking heart icon ( ), to indicate the device is powered and ready to start Heart icon 2. Press and hold the Start/Stop button for 3 seconds. The device will respond with an audible tone and display the start delay screen as shown below (run icon ( ) and start delay icon ( ) are displayed). The display will count down the programmed start delay time until 0 minutes remain. At the end of the start delay countdown, the start delay icon will turn off and the VaxAlert will enter measurement (run) mode. Delay start counter: In this example, 6 minutes have elapsed in a 60 minute start delay cycle Start delay icon (hourglass) - 2 -

3. In measurement mode, the VaxAlert display will present elapsed trip time, last measured temperature, and alarm condition/excursion event information (if alarm activity is recorded). Alarm excursion event counter Elapsed trip time (D, H, M) Last temperature reading Alarm indicator(s) to each triggered alarm VaxAlert In Measurement Mode With Alarms = no alarm(s) Elapsed trip time (D, H, M) Last temperature reading VaxAlert In Measurement Mode Without Alarms - 3 -

Stopping the VaxAlert: 1. Press and hold the Start/Stop button for 3 seconds. The VaxAlert will emit an audible tone and display the stop mode screen as shown below (stop icon ( ) is displayed) NOTE: The VaxAlert is programmed to automatically stop after 10 days of elapsed trip time. Total elapsed trip time Alarm indicator(s) to each triggered alarm Alarm excursion counter VaxAlert In Stop Mode With Alarms = no alarm(s) Total elapsed trip time VaxAlert In Stop Mode Without Alarms - 4 -

Retrieving alarm event information from the VaxAlert (HISTORY mode): 1. If the VaxAlert experiences alarm events (excursions), the device will record detailed information for up to nine total alarm events (three for each of the alarm settings). The alarm history information will be retained in the VaxAlert and can be viewed for a minimum of six months after stopping the device. 2. To view the alarm event history, press the or scroll buttons (in stop or measurement mode). The VaxAlert will emit an audible tone and display a history mode screen as shown below. Repeated presses of the or scroll buttons will cycle the alarm event history screens through all recorded alarm events (up to 9 maximum events). 3. During history mode operation, the screen will return to the stop or measurement mode screen if no additional button presses are initiated within 15 seconds. If the VaxAlert has not recorded any alarms, activating the or scroll buttons will not impact the display. Elapsed time for the excursion event (alarm) Maximum temperature recorded during the excursion event Excursion event indicator (1 thru 9) Alarm indicator to the triggered alarm for the event VaxAlert In History Mode, High Alarm Event In the example above, the first alarm event for this trip is a >= 30ºC, 10 HR alarm at 1 day, 5 hr and 2 minute elapsed time. The maximum temperature recorded during the >= 30ºC 10 HR alarm event is 40.4ºC. - 5 -

Elapsed time for the excursion event (alarm) Minimum temperature recorded during the excursion event VaxAlert In History Mode, Low Alarm Event Excursion event indicator (1 thru 9) Alarm indicator to the triggered alarm for the event In the example above, the first alarm event for this trip is a <= -0.5ºC, 1 HR alarm at 0 day, 1 hr and 6 minute elapsed time. The minimum temperature recorded during the <= -0.5ºC 1 HR alarm event is -18.9ºC. Elapsed time for the excursion event (alarm) Maximum temperature recorded during the excursion event Excursion event indicator (1 thru 9) Alarm indicator to the triggered alarm for the event VaxAlert In History Mode, High Alarm Event In the example above, the fourth alarm event for this trip is a >= 30ºC, 10 HR alarm at 6 day, 4 hr and 17 min elapsed time. The maximum temperature recorded during the >= 30ºC 10 HR alarm event is 41.1ºC. - 6 -

Battery Notes: The VaxAlert contains a CR Lithium battery. Please observe the following safety precautions. a. Dispose of or recycle the battery in accordance with your local regulations. b. Do not expose the device to extreme temperatures as this may lead to the destruction of the battery and could cause injury. c. Keep out of the reach of children. d. Battery is indicated on the screen at the bottom left corner. Accuracy and proper function of the device cannot be assured once the low battery signal icon is displayed. - 7 -