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TEMPERATURE MANAGEMENT SYSTEM
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Users should not use cleaning or decontamination methods different from
those recommended by the manufacturer without first checking with the
manufacturer that the proposed methods will not damage the equipment.
Do not use bleach (sodium hypochlorite) as it may damage the system.
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Medivance will not be responsible for patient safety or equipment
performance if the procedures to operate, maintain, modify or service the
Medivance Arctic Sun™ Temperature Management System are other than
those specified by Medivance. Anyone performing the procedures must be
appropriately trained and qualified.
Complications
Targeted Temperature Management can trigger pathophysiological side-
effects on the body such as but not limited to: cardiac dysrhythmia, electrolyte
and pH balance, metabolic changes, hemodynamic changes, blood-glucose
balance, infection, shivering, and can affect the coagulation, respiratory, renal
and neurological systems. The controlling of patient temperature should only
be performed under the supervision of a qualified healthcare professional.
System Setup
Unpack
1) Unpack the Arctic Sun™ Temperature Management System Control Module
and accessories.
2) Allow the control module to remain upright for at least 2 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 Medivance approved cables and accessories with the
Arctic Sun™ Temperature Management System Control Module. Connect
the Fluid Delivery Line, Patient Temp 1 cable, Patient Temp 2 cable (optional)
and Fill Tube to the back of the control module.
2) Plug the Power Cord into the wall outlet. Position Arctic Sun™ Temperature
Management System so that access to the power cord is not restricted.
Patient Temp 1
Strain Relief
Patient
Temp Cable
Fill Tube
Storage Slot
Fill Tube
Input Port
Fill Tube
Drain Valves
4
Power On
1) Turn the power ON by activating the Power Switch.
2) The control module will automatically go through a brief self-test of the
independent safety alarm.
3) A New User Training module option is available from the start up screen.
4) When the self-test is complete, the Patient Therapy Selection screen will
appear on the control panel.
Fill Reservoir
1) Fill the reservoir with sterile water only.
2) Four liters of water will be required to fill the reservoir at
initial installation.
3) Add one vial of Arctic Sun™ Temperature Management System Cleaning
Solution to the sterile water.
4) From the Patient Therapy Selection screen, press either the Normothermia
or Hypothermia button, under the New Patient heading.
5) From the Hypothermia or Normothermia therapy screen, press the
Fill Reservoir button.
6) The Fill Reservoir screen will appear. Follow the directions on
the screen.
Functional Verification
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 Hypothermia button
to display the Hypothermia therapy screen.
3) From the Hypothermia therapy screen, press the Manual Control button to
open the Manual Control 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 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 6°C.
13) Press the Stop button to stop Manual Control
Patient Temp 2
14) Press the Cancel button to close the Manual Control window
Power Switch
15) Power Off the control module.
Patient Temp
Chapter 2 – Patient Therapy
Output
Place ArcticGel™ Pads
Read the Instructions for Use that accompany the ArcticGel™ Pads.
Examine each pad for damage prior to placement.
Fluid Delivery
Line
Connect ArcticGel™ Pads
While holding the pad line tubing, insert the clear pad line connector into
the Fluid Delivery Line manifold. Do not press or squeeze the wings when
connecting. The connector will click into place. Check the surface of the device
for mechanical damage prior to use.
Air Filter
Temperature Probe Placement
Patient temperature control with the Arctic Sun™ Temperature Management
Power Cord
System requires patient temperature feedback provided by an indwelling
patient temperature probe connected to the Patient Temperature 1 connector
on the back of the Control Module. Any commercially-available Yellow Springs
Instrument 400 Series (YSI 400) compatible patient temperature probe can be
connected to the Arctic Sun™ Temperature Management System. Refer to the
manufacturer's Instructions for Use for the specific indications and temperature
probe placement.
O P E R A T O R ' S M A N U A L
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