Medivance BD Arctic Sun 6000, Operator'S Manual

Page: 14 / 57

Operator’s Manual
14
V. SETUP PROCEDURE
UNPACK
1) Unpack the Arctic Sun™ Temperature Management
System Control Module and accessories.
2)
Allow the Control Module to remain upright for at least two
hours prior to completing the installation and setup
procedure in order to allow the chiller oil to settle. Damage
to the chiller compressor may result otherwise.
CONNECTIONS
1) Use only approved cables and accessories with the Arctic
Sun™ Temperature Management System Control Module
(Appendix B).
2) Inspect the accessories for wear, breakage, or fraying
before use. Replace if necessary.
3) Connect the Fluid Delivery Line, Temp In 1 cable, Temp In
2 cable (optional), Temp Out cable and Fill Tube to the
back of the Control Module.
4) Plug the Power Cord into the wall outlet. Position the
Arctic Sun™ Temperature Management System so that
access to the power cord is not restricted.
POWER ON
1) Power On by activating the power switch on the back of
the device.
2) The patient Therapy Selection screen will appear on the
control panel.
FILL RESERVOIR
Approximately four liters of sterile water will be required to fill
the reservoir at initial installation. Fill the reservoir with sterile
water only. When filling the Control Module during initial
installation or when completely empty, add one vial of Arctic
Sun™ Temperature Management System Arctic Sun Cleaning
Solution to the sterile water. It is recommended to add the vial
when filling with the second liter of sterile water.
1) From the patient Therapy Selection screen, select the
button next to either Normothermia or Hypothermia under
the New Patient heading. Select any pad type to continue.
2) From the Hypothermia or Normothermia therapy screen,
press the Fill Reservoir button.
3) The Fill Reservoir screen will appear. Follow the
directions on the screen.
4) The filling process will automatically stop when the
reservoir is full. Continue to replace the bottles of sterile
water until the filling process stops.
5) When the Fill Reservoir process is complete, the screen
will close.
6) To stop the process early, press the Stop button.
NOTE: If the filling cycle is stopped prior to completion,
the reservoir will not be full and may requiring filling after
fewer patient therapies have been performed.
7) Press the Cancel button to close the screen.
FUNCTIONAL VERIFICATION
Certificates of Conformance for calibration, performance, and
electrical safety tests are included with the shipment of each
Arctic Sun™ Temperature Management System. To verify the
system will heat and cool properly, perform the following
functional verification procedure after initial setup and
installation of the Control Module.
1) Power On the Control Module.
2) From the patient
Therapy Selection screen, press the
button next to Hypothermia to display the Hypothermia
therapy screen. Select the adult pad type to continue.
3) From the Hypothermia therapy screen, press the Manual
Control button to open the Manual Control window. If the
Manual Control button is not visible, select the Adjust
button at the bottom of the screen and select the More
button to access the therapy settings screen. Enable
Manual Control and save your settings to close the
window.
4) Use the Up and Down arrows to set the Manual Control
water target temperature to 40°C and the duration to 30
minutes.
5) Press the Start button to initiate Manual Control. Allow at
least 3 minutes for the system to stabilize.
6) Monitor the flow rate and water temperature in the System
status area on the Hypothermia therapy screen.
7) Verify that the flow rate reaches at least 1.5 liters/minute.
8) Verify that the water temperature increases to at least
30°C.
9) Press the Stop button.
10) Set the Manual Control water target temperature to 4°C
and the duration to 30 minutes.
11) Press the Start button to initiate Manual Control .
12) Monitor the flow rate and water temperature in the System
status area of the Hypothermia therapy screen. Verify
that the water temperature drops to at least 6°C.
13) Press the Stop button to stop Manual Control
14) Press the Cancel button to close the Manual Control
window.
15) Before placing the device into clinical use, it is
recommended to disable Manual Control unless requested
by clinical users. Select the
Adjust button at the bottom of
the therapy screen and select the More button to access
the therapy settings screen. Disable Manual Control and
save your settings to close the window.
16) Power Off the Control Module.