1. FROST I Site Initiation Visit version 1.4

2. IVTM System

5. Control Buttons To provide confirmation, each time a button is pressed, a “key click” sound is produced by the annunciator. Target Temperature o A screen that allows you to set the patient’s target temperature Rate Degree/Hr o Set a cooling/warming rate

6. Control Buttons Standby/Run o Press to go between standby mode or run mode o An alarm can place the System into standby mode automatically o Press this button to return to run mode Control Knob (Menu/Enter) o The dual-function control knob and pushbutton o Press the knob to display a menu screen o Turn the knob to scroll temperature trend graphs

7. SYSTEM SET UP Check the level of coolant o If the level is below the bottom indicator line, add distilled water until the liquid is at the top indicator line Plug in the power cord and turn the power switch on o The System performs a short self-test o At the end of the self-test there will be two short beeps

8. SYSTEM SET UP Select the Bath Pre-Set: Pre-Cool o Choose the “Pre-Cool” option and press knob once to enter

9. SYSTEM SET UP Are you starting a New Patient? o Always choose “NO” and press the knob once to enter the selection

10. SYSTEM SET UP Select patient Target Temperature o Press the knob once to enter the selection

11. SYSTEM SET UP Select Treatment Mode o Turn the knob to highlight the “Max Power” mode. Press the knob once to enter the selection Wait until Self-Test is finished o If the System has not yet finished its self-tests, the Self-Test screen is displayed

12. Installing the Start-up Kit

13. System Sensor Check Setup Sensor Checks o If the system finishes its self-test before you complete installing the Start-up Kit, you will see the following Check Screen o An item in RED requires your attention

14. System Sensor Check

15. Thermogard XP is now ready When the Start-up Kit is loaded and primed, the system will enter STANDBY

16. Connection to the patient

17. Connection to the patient cont.

18. Connection to the patient Temporary disconnection from the Patient o Press the Standby/Run button to place the System in Standby mode o Disconnect the temperature probes from their cables o Leave the temperature probes in the patient o Using aseptic technique, disconnect the saline lines from the Quattro catheter and cap all lines or connect them to each other Reconnecting after a temporary disconnection o Using aseptic technique, reconnect the saline tubing to the Quattro catheter Reconnect the temperature probes to their cables o Restart treatment by pressing the Standby/Run button

19. Ending Treatment Press the Standby/Run button. Using aseptic technique, disconnect both tubing connectors from the catheter. Cross connect the loose ends of the Start-up Kit Disconnect the primary and secondary patient temperature probes from their cables

20. Ending Treatment The cables connecting the device with temperature probe are reusable o Do not throw away cables for temperature probe Remove the Quattro catheter from the patient o Leave the loose ends of tubing connectors from the Quattro catheter open, so that the saline solution can flow from the catheter when removing it from the vessel Remove the patient temperature probe/s from the patient Press the knob once. Select End Procedure