Medivance ARCTIC SUN 5000 User manual

OPERATOR’S MANUAL

Languages
English ................................................................................................................................1
Český (Czech) ..................................................................................................................15
Danske (Danish) ............................................................................................................29
Deutsch (German) .........................................................................................................43
Ελληνικα (Greek).............................................................................................................59
Español (Spanish) ..........................................................................................................73
Français (French)...........................................................................................................89
Italiano (Italian) ............................................................................................................105
Magyar (Hungarian) .....................................................................................................121
Nederlandse (Dutch)...................................................................................................135
Norske (Norwegian)....................................................................................................149
Polski (Polish) ................................................................................................................163
Português (Portuguese)..............................................................................................177
Slovenčina (Slovakia) ..................................................................................................193
Suomalainen (Finnish).................................................................................................207
Svenska (Swedish) ......................................................................................................221
Türkçe (Turkish).............................................................................................................235
 (Russian)...........................................................................................................249
日本語 (Japanese).......................................................................................................263
Ё᭛ㅔԧ (Chinese - Simplified).........................................................................277
խഏႚอʳ (Chinese - Traditional) .....................................................................291
한국어 (Korean).....................................................................................................305
Table of Contents
Chapter 1 – Getting Started ...........................................................................................1
Indications for Use ...........................................................................................................1
Warnings and Cautions ...................................................................................................1
System Setup ....................................................................................................................2
Chapter 2 – Patient Therapy ..........................................................................................3
Place ARCTICGEL™Pads .....................................................................................................3
Connect ARCTICGEL™Pads ................................................................................................3
Temperature Probe Placement ......................................................................................3
Patient Therapy Selection ..............................................................................................3
Therapy Screens...............................................................................................................4
Initiate Normothermia (Control Patient)........................................................................4
Initiate Hypothermia (Cool Patient and Rewarm Patient) ..........................................5
End Therapy ......................................................................................................................6
Chapter 3 – Normothermia Settings .............................................................................6
Normothermia Settings ...................................................................................................6
Chapter 4 – Hypothermia Settings ................................................................................7
Hypothermia Settings ......................................................................................................7
Chapter 5 – Advanced Setup .........................................................................................7
Chapter 6 – Alarms and Alerts ......................................................................................8
Alarms ................................................................................................................................8
Main Safety Alarms .........................................................................................................8
Non-Recoverable Alarms ...............................................................................................8
Recoverable Alarms ........................................................................................................8
Alerts ..................................................................................................................................8
Chapter 7 – Maintenance and Service ........................................................................8
Cleaning and Maintenance ............................................................................................8
Software Update ..............................................................................................................9
Service ...............................................................................................................................9
Calibration..........................................................................................................................9
Appendix A: Product Specifications............................................................................9
Technical Description ......................................................................................................9
Environmental Conditions................................................................................................9
ARCTIC SUN®Temperature Management System ........................................................10
Appendix B: Symbols ...................................................................................................11
Appendix C: Electromagnetic Compatibility ...........................................................12
OPERATOR’S MANUAL
The 24/7 Helpline is intended to
assist healthcare professionals
with technical questions they
may have regarding the use of
the ARCTIC SUN®Temperature
Management System. While the
Helpline is staffed by licensed
critical care nurses, they are
not able to provide medical or
nursing advice or to prescribe
treatment.

1
Chapter 1 – Getting Started
Indications for Use
The ARCTIC SUN®Temperature Management System is intended for
monitoring and controlling patient temperature.
Warnings and Cautions
Warnings
• Do not use the ARCTIC SUN®Temperature Management System in the
presence of flammable agents because an explosion and/or fire may result.
• Do not use high frequency surgical instruments or endocardial catheters
while the ARCTIC SUN®Temperature Management System is in use.
• There is a risk of electrical shock and hazardous moving parts. There are
no user serviceable parts inside. Do not remove covers. Refer servicing to
qualified personnel.
• Power cord has a hospital grade plug. Grounding reliability can only be
achieved when connected to an equivalent receptacle marked “hospital
use” or “hospital grade”.
• When using the ARCTIC SUN®Temperature Management System, note that all
other thermal conductive systems, such as water blankets and water gels, in
use while warming or cooling with the ARCTIC SUN®Temperature Management
System may actually alter or interfere with patient temperature control.
• Do not place ARCTICGEL™Pads over transdermal medication patches as
warming can increase drug delivery, resulting in possible harm to the patient.
Cautions
• This product is to be used by or under the supervision of trained, qualified
medical personnel.
• Federal law (USA) restricts this device to sale, by or on the order of a
physician.
• Use only distilled or sterile water. The use of other fluids will damage the
ARCTIC SUN®Temperature Management System system.
• When moving the ARCTIC SUN® Temperature Management System always
use the handle to lift the controller over an obstacle to avoid over balancing.
• The patient’s bed surface should be located between 30 and 60 inches (75
cm and 150 cm) above the floor to ensure proper flow and minimize risk of
leaks.
• The clinician is responsible to determine the appropriateness of custom
parameters. When the system is powered off, all changes to parameters
will revert to the default unless the new settings have been saved as
new defaults in the Advanced Setup screen. For small patients (≤30 kg)
it is recommended to use the following settings: Water Temperature
High Limit ≤40°C (104°F); Water Temperature Low Limit ≥10°C (64.4 °F);
Control Strategy =2.
• The operator must continuously monitor patient temperature when using
Manual Control and adjust the temperature of the water flowing through the
pads accordingly. Patient temperature will not be controlled by the ARCTIC
SUN®Temperature Management System in Manual Control.
• Due to the system’s high efficiency, Manual Control is not recommended
for long duration use. The operator is advised to use the automatic therapy
modes (e.g. Control Patient, Cool Patient, Rewarm Patient) for automatic
patient temperature monitoring and control.
• The
ARCTIC SUN®Temperature Management System will monitor and control
patient core temperature based on the temperature probe attached to the
system. The clinician is responsible for correctly placing the temperature
probe and verifying the accuracy and placement of the patient probe at the
start of the procedure.
• Medivance recommends measuring patient temperature from a second site
to verify patient temperature. Medivance recommends the use of a second
patient temperature probe connected to the ARCTIC SUN®Temperature
Management System Temperature 2 input as it provides continuous
monitoring and safety alarm features. Alternatively, patient temperature
may be verified periodically with independent instrumentation.
• The displayed temperature graph is for general information purposes only
and is not intended to replace standard medical record documentation for
use in therapy decisions.
• Patient temperature will not be controlled and alarms are not enabled in
Stop Mode. Patient temperature may increase or decrease with the ARCTIC
SUN®Temperature Management System in Stop Mode.
• Carefully observe the system for air leaks before and during use. If the pads
fail to prime or a significant continuous air leak is observed in the pad return
line, check connections. If needed, replace the leaking pad. Leakage may
result in lower flow rates and potentially decrease the performance of the
system.
• The
ARCTIC SUN®Temperature Management System is for use only with the
ARCTICGEL™Pads.
• The ARCTICGEL™Pads are only for use with the ARCTIC SUN®Temperature
Management Systems.
• The ARCTICGEL™Pads are non-sterile for single patient use. Do not reprocess
or sterilize. If used in a sterile environment, pads should be placed
according to the physician’s request, either prior to the sterile preparation
or sterile draping. ARCTICGEL™Pads should not be placed on a sterile field.
• Use pads immediately after opening. Do not store pads once the kit has
been opened.
• Do not place ARCTICGEL™Pads on skin that has signs of ulceration, burns,
hives, or rash.
• While there are no known allergies to hydrogel materials, caution should
be exercised with any patient who has a history of skin allergies or
sensitivities.
• Do not allow circulating water to contaminate the sterile field when patient
lines are disconnected.
• The water content of the hydrogel affects the pad’s adhesion to the skin
and conductivity, and therefore, the efficiency of controlling patient
temperature. Periodically check that pads remain moist and adherent.
Replace pads when the hydrogel no longer uniformly adheres to the skin.
Replacing pads at least every 5 days is recommended.
• Do not puncture the ARCTICGEL™Pads with sharp objects. Punctures will
result in air entering the fluid pathway and may reduce performance.
• If accessible, examine the patient’s skin under the ARCTICGEL™Pads often,
especially those at higher risk of skin injury. Skin injury may occur as a
cumulative result of pressure, time and temperature. Do not place bean bag
or other firm positioning devices under the ARCTICGEL™Pads. Do not place
positioning devices under the pad manifolds or patient lines.
• The rate of temperature change and potentially the final achievable
patient temperature is affected by many factors. Treatment
application, monitoring and results are the responsibility of the
attending physician. If the patient does not reach target temperature
in a reasonable time or the patient is not able to be maintained at the
target temperature, the skin may be exposed to low or high water
temperatures for an extended period of time which may increase
the risk for skin injury. Ensure that pad sizing / coverage and custom
parameter settings are correct for the patient and treatment goals,
water flow is greater than or equal to 2.3 liters per minute and the
patient temperature probe is in the correct place. For patient cooling,
ensure environmental factors such as excessively hot rooms, heat
lamps, and heated nebulizers are eliminated and patient shivering
is controlled. Otherwise, consider increasing minimum water
temperature, modifying target temperature to an attainable setting or
discontinuing treatment. For patient warming, consider decreasing
maximum water temperature, modifying target temperature to an
attainable setting or discontinuing treatment.
• Due to underlying medical or physiological conditions, some patients are
more susceptible to skin damage from pressure and heat or cold. Patients
at risk include those with poor tissue perfusion or poor skin integrity due to
diabetes, peripheral vascular disease, poor nutritional status, steroid use
or high dose vasopressor therapy. If warranted, use pressure relieving or
pressure reducing devices under the patient to protect from skin injury.
• Do not allow urine, antibacterial solutions or other agents to pool
underneath the ARCTICGEL™Pads. Urine and antibacterial agents can absorb
into the pad hydrogel and cause chemical injury and loss of pad adhesion.
Replace pads immediately if these fluids come into contact with the
hydrogel.
• Do not place ARCTICGEL™Pads over an electrosurgical grounding pad. The
combination of heat sources may result in skin burns.
• If needed, place defibrillation pads between the ARCTICGEL™pads and the
patient’s skin.
• Carefully remove ARCTICGEL™Pads from the patient’s skin at the completion of use.
Discard used ARCTICGEL™Pads in accordance with hospital procedures for medical
waste.
ENGLISH
The current Operator’s Manual can be found at www.medivance.com/manuals.

2
• The USB data port is to be used only with a standalone USB flash drive. Do not
connect to another mains powered device during patient treatment.
• 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.
• Medivance will not be responsible for patient safety or equipment performance if the
procedures to operate, maintain, modify or service the Medivance ARCTIC SUN®Tem-
perature Management System are other than those specified by Medivance. Anyone
performing the procedures must be appropriately trained and qualified.
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 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 Man-
agement System so that access to the power cord is not restricted.
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 or distilled water only.
2) Four liters of water will be required to fill the reservoir at initial installa-
tion.
3) Add one vial of ARCTIC SUN®Temperature Management System Cleaning
Solution to the sterile or distilled water.
4) From the Patient Therapy Selection screen, press either the Normo-
thermia 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.
Power Switch
Patient
Temp
Out
Fluid
Delivery
Line
Power Cord
Equipotential
Stud
Patient
Temp 1
Strain Relief
Patient
Temp 2
Patient
Temp Cable
Fill Tube
Storage
Fill Tube/Port
Drain Ports
Air Filter
OPERATOR’S MANUAL

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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 but-
ton 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 dura-
tion 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
14) Press the Cancel button to close the Manual Control window
15) Power Off the control module.
Chapter 2 – Patient Therapy
Place ARCTICGEL™Pads
Read the Instructions for Use that accompany the ARCTICGEL™Pads.
Examine each pad for damage prior to placement.
Connect ARCTICGEL™Pads
Orient the blue and white colors on the pad line connector and Fluid
Delivery Line. 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.
Temperature Probe Placement
Patient temperature control with the ARCTIC SUN®Temperature Management
System requires patient temperature feedback provided by an indwelling
patient temperature probe connected to the Patient Temperature 1 con-
nector on the back of the Control Module. Any commercially-available
Yellow Springs Instrument 400 Series (YSI 400) compatible patient tempera-
ture 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.
Patient Therapy Selection
Use the Patient Therapy Selection screen to initiate a New Patient, Con-
tinue a Current Patient, or access the Advanced Setup screen.
New Patient - Normothermia
Select Normothermia if the therapy goal is to maintain a patient tempera-
ture at a pre-defined target temperature for an indefinite period of time.
Press the Normothermia button to display the Normothermia therapy
screen.
New Patient - Hypothermia
Select Hypothermia to reduce and maintain a patient temperature at a set
target temperature for a defined period of time, then slowly re-warm the
patient at a controlled re-warming rate. Press the Hypothermia button to
display the Hypothermia therapy screen.
Current Patient
The Continue Current Patient button and the date and time that the current
therapy was paused will display on the Patient Therapy Selection screen if
a patient therapy was paused within the past 6 hours.
Press the Continue Current Patient button to resume a paused patient
therapy.
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Therapy Screens
Normothermia Therapy Screen
Hypothermia Therapy Screen
The following information is displayed and functions are available from the
Normothermia and Hypothermia therapy screens.
A Cool Patient window (Hypothermia screen)
Control Patient window (Normothermia screen)
B Rewarm Patient window (Hypothermia screen)
C Patient Monitoring area
D Patient Temperature
E Patient Temperature 2 (if enabled)
F Patient Temperature Trend Indicator
G System Monitoring area
H Water Temperature
I Water Flow Rate
J Reservoir Water Level
K Therapy Graph
L Manual Control button (if enabled)
M Empty Pads button
N Fill Reservoir button
O Therapy Selection / Screen Lock button
P Temperature Units button (if enabled)
Q Stop button
R Help button
Initiate Normothermia (Control Patient)
Normothermia therapy is initiated and managed, and patient temperature
is automatically controlled to a set target temperature from the Control
Patient window in the Normothermia therapy screen. The Control Patient
window displays the patient target temperature and the duration since the
initiation of normothermia therapy.
To initiate Normothermia therapy:
1) From the Patient Therapy Selection screen, press the Normothermia
button to display the Normothermia therapy screen.
2) The default patient target temperature will display in the Control Pa-
tient window.
3) To modify the patient target temperature, press the Adjust button to
display the Control Patient-Adjust window.
4) Control Patient To: Use the Up and Down arrows to set the desired
patient target temperature to control the patient.
5) Press the Save button to save the new settings and close the Control
Patient-Adjust window
6) Press Start, in the Control Patient window to initiate therapy. You will
hear a tone and then a voice stating “Therapy Started”. Additionally,
the Control Patient window and the ARCTIC SUN®Temperature Manage-
ment System icon will blink, indicating that therapy is in progress.
A
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F
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OPERATOR’S MANUAL

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Initiate Hypothermia (Cool Patient and Rewarm Patient)
Hypothermia therapy is initiated and managed, and patient temperature is
automatically controlled to a set target temperature from the Cool Patient
and Rewarm Patient windows in the Hypothermia therapy screen.
The Cool Patient window displays the cooling phase patient target
temperature and the length of time remaining in the cooling phase of the
Hypothermia therapy.
The Rewarm Patient window displays the rewarming phase patient target
temperature and the length of time remaining in the rewarming phase of
the Hypothermia therapy.
To initiate hypothermia therapy:
From the Patient Therapy Selection screen, press the Hypothermia button
to display the Hypothermia therapy screen.
1. Cool Patient Settings
• The default patient target temperature and duration will display in the
Cool Patient window.
• To modify the patient target temperature and duration, press the Adjust
button to display the Cool Patient-Adjust window.
• Cool Patient To: Use the Up and Down arrows on the left side to set
the desired patient target temperature to cool the patient
• Cool Patient For: Use the Up and Down arrows on the right side to set
the cooling duration to cool the patient before rewarming begins.
• Press the Save button to save the new settings and close the Cool
Patient-Adjust window
2. Rewarm Patient Settings
• The default patient target temperature and duration will display in the
Rewarm Patient window.
• To change the rewarming phase patient target temperature and
rewarming rate, press the Adjust button in the Rewarm Patient window
to display the Rewarm Patient-Adjust screen. Use the Up and Down ar-
rows on the left side to set the desired final patient target temperature.
• Rewarm Patient To: Use the Up and Down arrows on the right side to
set the desired final patient target temperature.
• Rewarm at a Rate of: Use the Up and Down arrows in the center of the
screen to set the rewarming rate.
• Rewarm Patient From: When cooling a patient, adjustment of the
Rewarm Patient From setting on the left side of the screen is disabled
and defaults to the Cool Patient target temperature.
• When rewarming a patient, the Rewarm Patient From adjustment is
enabled and the value can be modified. The Rewarm Patient From
setting is the temperature to which the system is currently controlling
the patient. The Rewarm Patient From temperature will automatically
increase as the rewarming process continues. This feature allows the
rewarming procedure to be optimized by allowing complete control of
the rewarming ramp.
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6
• Using the Rewarm Patient From temperature, the Rewarm Patient To
temperature and the rewarming rate settings, the system will calculate
and display the rewarming duration and the date/time at which the the
patient will reach the final rewarming target temperature.
• Press the Save button to save the new settings and close the Rewarm
Patient-Adjust window.
3. Initiate Patient Cooling
• Press Start, in the Cool Patient window to initiate therapy. You will hear
a tone and then a voice stating “Therapy Started”. Additionally, the Cool
Patient window and the ARCTIC SUN®Temperature Management System
icon will blink, indicating that therapy is in progress.
4. Initiate Patient Rewarming
• Upon completion of the cooling phase, there are two options for initia-
tion of patient rewarming, either Automatically or Manually, depending
on the Rewarming Begins setting in Hypothermia Settings.
• If Rewarming Begins is set to Automatically, the rewarming process
starts automatically when the Cool Patient therapy is complete and the
duration reaches zero.
• If Rewarming Begins is set to Manually, the rewarming process starts
when the Start button is pressed in the Rewarm Patient window. The
cooling process will continue until the Rewarm Patient Start button is
pressed. An Alert will occur when the Cool Patient duration reaches
zero.
End Therapy
• From the Normothermia therapy or Hypothermia therapy screen, press
the Stop button to terminate water circulation to the pads.
• Press the Empty Pads button, and follow the instructions to purge the
pads of water.
• Disconnect the pads from the Fluid Delivery Line.
• Slowly and carefully remove pads from the patient skin.
• Discard the used pads in accordance with hospital procedures for
medical waste.
• Press the power switch Off.
If power is lost while the power switch is in the On position, an audible alert
will be issued until it is switched Off. This alerts the user that the treatment
may have been accidentally stopped.
Chapter 3 – Normothermia Settings
Normothermia Settings
Use the Normothermia Settings screen to view the current settings and
modify the settings for the following parameters. To modify any parameter
setting, press the Adjust button to the right of the parameter.
Normothermia Settings screen parameters:
Therapy Settings
• Timer Begins
Water Temperature Settings
• Pre-Condition Water
• Manual Control
• High Water Limit
• Low Water Limit
Patient Temperature Settings
• High Patient Alert
• Low Patient Alert
• Control Strategy
Display Settings
• Temperature Units
• Temperature Units Adjust
• Patient Temp 2
• Speaker Volume
To access the Normothermia Settings screen:
1) Press Adjust on the Control Patient window.
2) Press the More button on the Control Patient Adjust window.
3) The Normothermia Settings screen will be displayed.
4) To save the new settings as the current patient therapy settings, press
the Close button. For instructions on saving the settings as the system
defaults, see Advanced Setup.
OPERATOR’S MANUAL

7
Chapter 4 – Hypothermia Settings
Hypothermia Settings
Use the Hypothermia Settings screen to view the current settings and
modify the settings for the following parameters. To modify any parameter
setting, press the Adjust button to the right of the parameter.
Hypothermia Settings screen parameters:
Therapy Settings
• Cooling Begins
• Rewarming Begins
Water Temperature Settings
• Pre-Condition Water
• Manual Control
• High Water Limit
• Low Water Limit
Patient Temperature Settings
• High Patient Alert
• Low Patient Alert
• Control Strategy
Display Settings
• Temperature Units
• Temperature Units Adjust
• Patient Temp 2
• Speaker Volume
To access the Hypothermia Settings screen:
1) Press Adjust on the Cool Patient window or the Rewarm Patient win-
dow.
2) Press the More button on the Cool Patient Adjust window or Rewarm
Patient Adjust window.
3) The Hypothermia Settings screen will be displayed.
4) To save the new settings as the current patient therapy settings, press
the Close button. For instructions on saving the settings as the system
defaults, see Advanced Setup.
Chapter 5 – Advanced Setup
Use the Advanced Setup screen to view the current settings and modify
the settings for the following parameters. To modify any parameter setting,
press the Adjust button to the right of the parameter.
Location / Time Settings
• Language
• Number Format
• Current Time
• Date Format
• Current Date
The following functions can be initiated from the Advanced Setup screen.
• Download Patient Data: The Patient Data for the last 10 (ten) cases are
stored on the ARCTIC SUN®Temperature Management System hard drive.
This data is maintained when the ARCTIC SUN®Temperature Management
System is powered down, or in the event of a total loss of power.:
• Calibration
• Total Drain
• Save All Settings As Default
Additionally, the following information can be viewed in the Advanced
Setup screen.
• Software Versions
• Last Calibration date
• Next calibration due
To access the Advanced Setup screen:
1) Press Advanced Setup button on the Patient Therapy Selection screen.
2) The Advanced Setup screen will be displayed.
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8
Chapter 6 – Alarms and Alerts
The ARCTIC SUN®Temperature Management System safety system continu-
ally monitors the state of the device and the patient, and issues alarms or
alerts to notify the user of conditions that may interfere with patient safety
or system performance.
There are two types of conditions: Alarms and Alerts.
An Alarm notifies the user that a condition that may potentially pose an
unsafe situation with respect to the patient or the device. An Alarm is a
High Priority condition that requires immediate operator response.
An Alert informs the user about patient and device status without interrupt-
ing the procedure. An Alert is a Medium Priority condition that requires
prompt operator response.
Alarms
An Alarm is denoted by an audio signal that repeats every 10 seconds
until the Alarm is cleared. The Alarm screen will appear that displays the
alarm number, alarm title, a description of the problem or conditions that
triggered the alarm, and solutions and instructions for troubleshooting and
resolving the alarm condition. If certain Alarm conditions are not acknowl-
edged by the operator within 2 minutes, a Reminder tone will sound. All
Alarm settings are maintained in the event of a mains power interruption.
Main Safety Alarms
While there are multiple alarms and safety features in the ARCTIC SUN®Tem-
perature Management System, there are five main safety alarms that will
place the device into Stop mode until the condition is addressed.
Alarm Specification
High Patient Temperature 39.5 °C (103.1 °F)
Low Patient Temperature 31.0 °C (87.8 °F)
High Water Temperature 42.5 °C / 44 °C (108.5 °F / 111.2 °F)
Low Water Temperature 3.0 °C / 3.5 °C (37.4 °F / 38.3 °F)
System Self-Test Failure At device power ON
Each time the ARCTIC SUN®Temperature Management System is powered
On, a system self test for the independent safety alarm is automatically run.
This test stimulates a “water high temperature” fault situation on both the
primary and secondary water temperature sensors. Both the primary and
secondary safety systems must respond to the fault and be verified by the
opposing safety system. If either safety systems do not respond appropri-
ately either an alarm 80 or 81 will be issued. Contact Medivance Customer
Support.
Non-Recoverable Alarms
If an Alarm condition occurs that prevents proper use of the device or
proper patient treatment (such as the five main safety alarms discussed
above), the system is placed into Stop mode and will not allow therapy to
continue. This type of Alarm is known as Non-Recoverable. If this situation
occurs, cycle the device power (turn device Off then On). If the alarm
recurs contact Medivance Customer Support.
Recoverable Alarms
Other Alarms that temporarily Stop the device until the user is able to
correct the cause and clear the Alarm are classified as Recoverable. If the
condition that initiated the alarm is not addressed and problem persists,
the Alarm will recur.
If a Recoverable Alarm occurs:
1) When an alarm is issued the device is placed into Stop mode.
2) Read the displayed instructions.
3) Note the Alarm number.
4) Press the Close button to clear the alarm.
5) Follow the instructions to correct the alarm condition. Perform the ac-
tions in the order listed until the alarm condition is resolved.
6) Once you have cleared the alarm, press the Start button in the therapy
window to restart therapy. You will hear a tone and a voice stating
“Therapy Started”. Additionally, the active therapy window and the
ARCTIC SUN®Temperature Management System icon will blink.
7) If the condition does not resolve, contact Medivance Customer Sup-
port.
Alerts
Alerts are denoted by an audio signal that repeats every 25 seconds. The
Alert screen will appear that displays the alert number, alert title, a de-
scription of the problem that triggered the alert, and solutions and instruc-
tions for troubleshooting and resolving the alert condition.
If an Alert occurs:
1) Read the displayed instructions.
2) Note the Alert number.
3) Press the Close button to clear the alert.
4) Follow the instructions to correct the alert condition. Perform the
actions in the order listed until the alarm condition is resolved. If the
condition does not resolve, contact Medivance Customer Support.
Chapter 7 – Maintenance and Service
Cleaning and Maintenance
Cleaning and Maintenance Routine cleaning and preventive maintenance
should be performed on the ARCTIC SUN®Temperature Management System
control module every 6 months at a minimum. This consists of cleaning
the external surfaces, accessories and chiller condenser, inspecting the
device, and replenishing the internal cleaning solution that suppresses
microorganism growth in the water reservoir and hydraulic circuit.
External Surfaces
• Clean the exterior body of the control module, fluid delivery lines,
power cords and temperature cables using a soft cloth and mild deter-
gent or disinfectant according to hospital protocol.
Condenser
• A dirty chiller condenser will significantly reduce the cooling capacity
of the control module.
• To clean the condenser, wipe the dust from the exterior grill using a
soft cloth. Depending on the quality of your institution’s air, periodically
OPERATOR’S MANUAL

9
remove the back cover and vacuum or brush the condenser fins. At a
minimum the condenser fins should be cleaned annually. Maintenance
activities should be performed by qualified personnel.
Device Inspection
• Periodically inspect the external areas of the device for damaged,
loose or missing parts, and frayed or twisted power cords and cables.
• Discontinue using the device displaying one or more of the above
conditions until the problem is corrected and has been verified to be
operating correctly.
Replenish Internal Cleaning Solution
Contact Medivance Customer Service to order internal cleaning solution.
To replenish the internal cleaning solution:
1) Drain the reservoir.
• Turn control module power Off.
• Attach the drain line to the two drain ports on the back of the
control module. Place the end of the drain line into a container. The
water will passively drain into the container.
2) Refill the reservoir.
• From the Hypothermia therapy screen or the Normothermia therapy
screen, press the Fill Reservoir button.
• The Fill Reservoir screen will appear. Follow the directions on the
screen.
• Add one vial of ARCTIC SUN®Temperature Management System
cleaning solution to the first bottle of distilled or sterile water.
• The filling process will automatically stop when the reservoir is full.
Continue to replace the bottles of sterile or distilled water until the
filling process stops.
• When the Fill Reservoir process is complete, the screen will close.
Software Update
Software updates will be provided from Medivance on a flash drive.
Installation of software updates will be performed via the USB port on the
front of the control module.
The software update feature will automatically initiate if the control module
detects the proper files on a flash drive inserted in the USB port at power
On.
To install software update:
1) Insert flash drive provided by Medivance into the USB port.
2) An image of a timer will display while the software update in being
installed, and will disappear when the software installation process is
completed.
3) After installation, the new software version will display in the Software
Version field in Advanced Setup.
Service
Contact Medivance Customer Support for technical support and customer
service instructions to enable appropriately qualified technical personnel to
repair those parts of the equipment that Medivance considers repairable.
Calibration
See ARCTIC SUN®5000 Temperature Management System Service Manual for
calibration requirements and instructions.
Appendix A: Product Specifications
Technical Description
The ARCTIC SUN®Temperature Management System is a thermoregulatory
device that monitors and controls patient temperature within a range of
32°C to 38.5°C (89.6°F to 101.3°F). The ARCTIC SUN®Temperature Manage-
ment System System consists of the Control Module and disposable
ARCTICGEL™Pads.
A patient temperature probe connected to the Control Module provides
patient temperature feedback to an internal control algorithm which
automatically increases or decreases the circulating water temperature to
achieve a pre-set patient target temperature determined by the clinician.
The ARCTIC SUN®Temperature Management System pulls temperature-con-
trolled water ranging between 4°C and 42°C (39.2°F and 107.6°F) through
the ARCTICGEL™Pads at approximately 0.7 liter per minute per pad. This
results in heat exchange between the water and the patient.
The ARCTIC SUN®Temperature Management System System Control Module
is a CLASS I mobile device (Type BF, IPX0 and Mode of Operation – Con-
tinuous) per classification scheme of IEC 601-1.
The ARCTIC SUN®Temperature Management System System Control Module
meets both the electromagnetic interference and susceptibility require-
ments of IEC 60601-1, and is compatible with other equipment that also
conforms to that standard. There is no known failure mode in the ARCTIC
SUN®Temperature Management System System Control Module associ-
ated with electromagnetic interference from other devices. See the ARCTIC
SUN®5000 Temperature Management System Service Manual for the full
declaration regarding electromagnetic compatibility.
Environmental Conditions
Temperature Range
Operating: .........................10ºC to 27ºC (50ºF to 80ºF)
Storage: .......................-30ºC to 50ºC (-20ºF to 120ºF)
At operating temperatures higher than 27ºC (80ºF), the refrigeration sys-
tem’s cooling capacity and therefore its ability to cool a patient is compro-
mised.
Humidity Range (relative humidity, non-condensing)
Operating:.................................................... 5% to 70%
Storage: .......................................................5% to 95%
Atmospheric Pressure Range:.....60 kPa to 110 kPa
ENGLISH

10
ARCTIC SUN®5000 Temperature Management System SpecificationsP
OPERATOR’S MANUAL
Parameter Specification
Therapy Modes Normothermia: Control Patient
Hypothermia: Cool Patient, Rewarm Patient
Heater Capacity 2500 BTU/hr / 750 Watts
Circulating Fluid Distilled or Sterile Water
Reservoir Capacity 3.5 liters
Water Flow Rate 5 liters per minute
Patient Probe Type YSI 400 Series compatible
Patient Temperature Inputs Patient Temp 1: control, monitor, alarm
Patient Temp 2: monitor, alarm
Patient Temperature Display Range 10°C to 44°C
50°F to 111.2°F
0.1°C / °F increments
Patient Temperature Measurement Accuracy ±0.4°C (10°C to 32°C)
±0.2°C (32°C to 38°C)
±0.4°C (38°C to 44°C)
Includes ±°0.1C external probe
Responses of the PCLCS (Physiologic Closed-Loop
Control System)
Settling Time: ~4.5 hrs
Relative Overshoot: <0.5°C
Command Overshoot: <0.5°C
Response Time: Warming (max) 33°C to 37°C: ~6 hrs
Cooling 37°C to 33°C: ~2 hrs
Steady State Deviation: 0
Tracking Error: 0
Note: All values derived from testing in simulated use.
Patient Temperature Control Range 32°C to 38.5°C
89.6°F to 101.3°F
0.1 °C/°F increments
Water Temperature Display Range 3°C to 45°C / 37.4°F to 113.0°F
0.1 °C/°F increments
Water Temperature Control Range (Manual) 4°C to 42°C / 39.2°F to 107.6°F
1 °C/°F increments
High Water Temperature Limit 36°C to 42°C / 96.8°F to 107.6°F
1 °C/°F increments
Low Water Temperature Limit 4°C to 25°C / 39.2°F to 77°F
1 °C/°F increments
Time to heat water from 20°C to 37°C 8 minutes (approximate)
Sound Pressure Alarm Tone: 70dB to 80dB at 1 meter, repeats every 10 seconds
Alert Tone: 63dB to 71dB at 1 meter, repeats every 25 seconds
Reminder Tone: 65dB at 3 meters, 0.5 seconds on/20 seconds off
Mains Input 115 VAC, 60 Hz, 11.0 Amp (nominal)
230 VAC, 50 Hz, 5.5 Amp
Leakage Current <300 μA
Operating Relative Humidity Range 5% to 70% non-condensing
Storage Relative Humidity Range 5% to 95% non-condensing
Operating Temperature Range 10°C to 27°C / 50°F to 80°F
Storage Temperature Range -30°C to 50°C / -20°F to 120°F
Atmospheric Pressure Range 60 kPa to 110 kPa
Dimensions Height: 35 inches (89 cm)
Width: 14 inches (36 cm)
Depth: 18.5 inches (47 cm)
Weight Empty: 43 kg / 95 lbs ; Filled: 47 kg / 103 lbs

11
For the safe and effective use of this device, the operator must consult the accompanying
documents prior to use
Identifies European Representative
This symbol adjacent to the patient connections means that the thermal probe connection is a
“Defibrillator-Proof, Type BF Applied Part”, per standard IEC 60601-1 and affords the degree of
patient protection defined in that standard for this type of applied part
Models of the ARCTIC SUN®Temperature Management System that bear the ETL Monogram
have been Certified for Safety by ETL Intertek in accordance with CAN/CSA C22.2 STD 601.1-
M90 and UL STD 6060.1.
Indicates high temperature part or component
Indicates that only sterile or distilled water should be used when filling the ARCTIC SUN®
Temperature Management System Control Module
Identifies Patient Temperature 1, the patient temperature probe input for monitoring and
control
Identifies Patient Temperature 2, the patient temperature probe input for monitoring
Identifies the drain port
Identifies the storage temperature range
Identifies the storage relative humidity range
Indicates electrical hazard
Do not re-use.
Risk of overbalance due to pushing, leaning, resting, etc.
Manufacturer
Appendix B: Symbols
The ARCTIC SUN®Temperature Management System Control module bears the following symbols:
ENGLISH

12
Appendix C: Electromagnetic Compatibility
Medical electrical equipment needs special precautions regarding elec-
tromagnetic compatibility. Ensure that the ARCTIC SUN®5000 Temperature
Management System is installed and used according to the electromag-
netic compatibility information provided. The following are guidance and
manufacturer’s declarations regarding electromagnetic compatibility for
the ARCTIC SUN®5000 Temperature Management System.
• The use of accessories or cables other than those specified or sold by
Medivance is not recommended. Use of unapproved accessories or
cables may result in increased emissions or in decreased immunity of
theARCTIC SUN®Temperature Management System.
• If the ARCTIC SUN®5000 Temperature Management System is used directly
adjacent to or stacked with other equipment, the user should periodi-
cally observe the ARCTIC SUN®5000 Temperature Management System
device to verify it operates normally in that environment.
• Portable and mobile RF communications equipment can affect Medical
Electrical Equipment.
1.1 EN/IEC 60601-1-2 Table 1
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The ARCTIC SUN®5000 Temperature Management System is intende d for use in the electro-
magnetic environment specified below. The customer or the end user of the Arctic Sun 5000
Temperature Management System should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The ARCTIC SUN®5000 Temperature
Management System uses RF energy
only for its internal function. Therefore,
its RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class A The ARCTIC SUN®5000 Temperature Man-
agement System unit is suitable for use in
all establishments other than domestic,
establishments and those directly con-
nected to the public low-voltage power
supply network that supplies buildings for
domestic purposes.
Harmonic emissions IEC
61000-3-2
Class A
Voltage fluctuations/
Flicker emissions IEC
61000-3-3
Complies
1.2 EN/IEC 60601-1-2 Table 2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ARCTIC SUN®5000 Temperature Management System unit is intended for use in the
electromagnetic environment specified below. The customer or the end user of the ARCTIC
SUN®5000 Temperature Management System unit should assure it is used only in such an
environment.
Immunity Test IEC60601 test level Compliance Level Intended Electromagnetic
Environment
Electromagnetic
discharge (ESD)
IEC 61000-4-2
+- 6kV contact
+- 8kV air
+- 6kV contact
+- 8kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+-2kV for power
supply lines
+-1kV for input/
output lines
+-2kV for power
supply lines
+-1kV for input/
output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
+-1kV differential
mode (line-line)
+-2kV common
mode (line-earth)
+-1kV differential
mode (line-line)
+-2kV common
mode (line-earth)
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95%
dip in UT) for 5
seconds
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95%
dip in UT) for 5
seconds
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the ARCTIC SUN®5000
Temperature Manage-
ment System unit requires
continued operation
during power mains
interruptions, it is recom-
mended that the ARCTIC
SUN®5000 Temperature
Management System
unit be powered from an
uninterruptible power
supply with sufficient
capacity to run the unit
for the maximum required
time of interruption.
Power frequency
(50/60Hz) magnetic
field
IEC 61000-4-8
3A/m 3 A/m Power frequency mag-
netic fields should be at
levels characteristic of a
typical location in a typi-
cal commercial or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
OPERATOR’S MANUAL

13
1.3 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 4:
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The ARCTIC SUN®5000 Temperature Management System unit is intended for use in the elec-
tromagnetic environment specified below. The customer or the end user of the ARCTIC SUN®
5000 Temperature Management System unit should assure it is used in such an environment.
Immunity
Test
IEC60601
test level
Compli-
ance Level
Intended Electromagnetic Environment
Conducted
RF
IEC 61000-
4-6
Radiated
RF
IEC 61000-
4-3
3Vrms
150kHz to
80MHz
3V/m
80MHz to
2.5GHz
3Vrms
150kHz to
80MHz
3V/m
80MHz to
2.5GHz
Portable and mobile RF communications equip-
ment should be used no closer to any part of the
ARCTIC SUN®5000 Temperature Management Sys-
tem unit, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80MHz to 800 MHz
d = 2.3√P 800MHz to 2.5GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recom-
mended minimum separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveya,
should be less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of equip-
ment marked with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from objects, structures and people.
aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be consid-
ered. If the measured field strength in the location in which the ARCTIC SUN®5000 Temperature
Management System unit is used exceeds the applicable RF compliance level above, the
ARCTIC SUN®5000 Temperature Management System unit should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the ARCTIC SUN®5000 Temperature Management System
unit.
bOver the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.
1.4 EN/IEC 60601-1-2:2007 Sub-clause 5.2.2.2 Table 6:
Recommended separation distances between portable and mobile RF communications
equipment and the ARCTIC SUN®5000 Temperature Management System unit
RF communications equipment can effect medical electrical equipment. The ARCTIC SUN®5000
Temperature Management System unit is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the ARCTIC SUN®
5000 Temperature Management System unit can help prevent electromagnetic interference
by maintaining a minimum distance between the portable and mobile RF communications
equipment (transmitters) and the ARCTIC SUN®5000 Temperature Management System unit
as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter in watts
(W)
Separation distance according to frequency of transmitter in meters
(m)
150kHz to 80MHz
d = 1.2√P
80MHz to 800MHz
d = 1.2√P
800MHz to 2.5GHz
d = 2.3√P
0.01 0.12 0.12 0.23
0.1 .38 .38 .73
1.0 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
ENGLISH