Medivance Arctic Sun Stat User manual

Arctic Sun™Stat
Temperature Management System
SERVICE MANUAL

Service Manual
Chapter 1 – Getting Started........................................................1
Introduction............................................................................................. 1
Indications for Use................................................................................ 1
Warnings and Cautions....................................................................... 1
Setup Procedure......................................................................................3
System Navigation................................................................................4
Fill Reservoir..............................................................................................5
Functional Verification ....................................................................... 5
Chapter 2 – Components..............................................................6
Hydraulic Components......................................................................... 6
Electronic Components ........................................................................ 6
Chapter 3 – Theory of Operation...............................................7
Main Hydraulic Circuits ........................................................................ 7
Ancillary Hydraulic Circuits ................................................................. 7
Electronic Control System ................................................................... 8
Chapter 4 – Maintenance.............................................................8
Maintenance Schedule......................................................................... 8
Clean the External Surfaces ............................................................... 8
Inspect Connectors and Cables........................................................ 9
Condenser.................................................................................................. 9
Device Inspection................................................................................... 9
Replenish Internal Solution................................................................ 9
Inspect Screen Protector...................................................................10
Inspect Fluid Delivery Line ...............................................................10
Inspect Manifold O-Rings..................................................................10
System Diagnostics .............................................................................10
Calibration...............................................................................................10
Chapter 5 – Advanced Setup.................................................... 10
Chapter 6 – Alarms ...................................................................... 14
Main Safety Alarms .............................................................................14
Medium Priority Alarms .....................................................................14
Non-Recoverable Alarms ...................................................................14
Recoverable Alarms .............................................................................14
Low Priority Alarms..............................................................................14
Alarms Listing.........................................................................................15
Chapter 7 – Troubleshooting.................................................... 28
7.1 Diagnostic Screen.........................................................................28
7.2 Event Log..........................................................................................28
7.3 General Troubleshooting Guide ..............................................28
7.4 Troubleshooting Assistance......................................................29
Chapter 8 – Component Replacement.................................. 30
8.1 Tools/Pre-service Requirements............................................. 35
8.2 Drain the Control Module ........................................................35
8.3 Remove RIM Back Panel............................................................ 35
8.4 Remove Front Case Assembly ................................................. 36
8.5 Replace Front Case Assembly Components...................... 36
8.6 Replace the Control Panel Assembly.................................... 37
8.7 Removing / Replacing Circuit Cards from Card Cage .... 37
8.8 Replace the Panel ESD Board................................................. 39
8.9 Replace the Connector Panel Bracket Assembly............. 39
8.10 Replace the USB to RS232 Converter (T.I.M.) ................ 40
8.11 Replace the Level Sensor........................................................ 40
8.12 Replace the Drain Valves........................................................ 41
8.13 Replace the Inlet/Outlet Manifold ..................................... 41
8.14 Replace the Inlet/Outlet Manifold Harness....................42
8.15 Replace the Power Supply...................................................... 42
8.16 Replace the AC PCB.................................................................. 43
8.17 Repairs Requiring removal of the
Upper Components ..................................................................... 43
8.18 Replace Mixing Pump.............................................................44
8.19 Replace Circulation Pump..................................................... 44
8.20 Replace the Heater.................................................................. 45
8.21 Replace the Flowmeter ........................................................... 46
8.22 Repairs requiring removal of Internal Components.... 46
8.23 Replace the Chiller Pump ....................................................... 47
8.24 Replace the Thermistor Sensor Harness.......................... 48
Chapter 9 – Calibration / Calibration Check ....................... 49
9.1 Calibration Test Unit................................................................... 49
9.2 When to Perform a Calibration or Calibration Check.... 49
9.3 Calibration Setup ......................................................................... 49
9.4 Performing a Calibration........................................................... 49
Chapter 10 – 2,000 Hour Service ............................................ 49
Appendix A: Product Specifications....................................... 50
Appendix B: Symbols...................................................................51
Appendix C: Electromagnetic Compatibility.......................55
Appendix D – Spare Parts and Accessories.......................... 57
Appendix E – Temperature Cables..........................................58
Appendix F – Shipping................................................................59
Appendix G – Software Upgrade ............................................ 60
Appendix H – Warranty.............................................................61
Appendix I – Transmission Interface Module Data Output
Format............................................................................ 62
TABLE OF CONTENTS

1
English
The current Service Manual can be found at www.medivance.com/manuals
Chapter 1 – Getting Started
Introduction
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).
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-controlled water ranging between 4°C and
40°C (39.2°F and 104°F) through the ArcticGel™ pads. This
results in heat exchange between the water and the patient.
The Arctic Sun™ Temperature Management System Control
Module is a Class I mobile device (Type BF, IPX0 and Mode
of Operation – Continuous) per classification scheme of IEC
60601-1.
The Arctic Sun™ Temperature Management System Control
Module meets both the electromagnetic interference
and susceptibility requirements 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 Control Module
associated with electromagnetic interference from other
devices. See Appendix C for the full declaration regarding
electromagnetic compatibility.
The Arctic Sun™ Temperature Management System was
designed with ease of service in mind and incorporates several
features that will assist clinical engineers in maintaining its
performance. These features include negative pressure flow
that eliminates water leaks, real-time air leak detection, and
performance monitoring. It also includes access to alarm logs
and past system case data, real-time diagnostic information,
simplified calibration and maintenance, and modular
construction allowing for simple repair if required.
Indications for Use
The Arctic Sun™ Temperature Management System is a
thermal regulating system, indicated for monitoring and
controlling patient temperature in adult and pediatric
patients of all ages.
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, water gels, and
patient coverings in use while warming, cooling, or not
delivering therapy 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 temperature can impact drug
delivery rate, resulting in possible harm to the patient.
• The Arctic Sun™ Temperature Management System
is not intended for use in the operating room
environment.
• Protection of mechanical equipment against the effects
of the discharge of cardiac defibrillators is dependent
upon the use of appropriate cables. Use of temperature
cables listed in the System Components section of the
Operator’s Manual is recommended.
• Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12
inches) to any part of the Arctic Sun™ Temperature
Management System, including cables specified by
the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
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 sterile water. The use of other fluids will
damage the Arctic Sun™ Temperature Management
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 and/or operator 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 (50°F);
Control Strategy = 2. It is recommended to use the
Patient Temperature High and Patient Temperature Low
alarm settings.
• Manual Control is not recommended for patient
temperature management. The operator is advised to
use the automatic therapy modes (e.g. Control Patient,
Cooling, Rewarming) 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.

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Service Manual
CAUTIONS (Continued)
• BD supplies temperature simulators (fixed value
resistors) for testing, training and demonstration
purposes. Never use this device, or other method, to
circumvent the normal patient temperature feedback
control when the system is connected to the patient.
Doing so exposes the patient to the hazards associated
with severe hypo- or hyperthermia.
• It is recommended to measure patient temperature
from a second site to verify patient temperature. BD
recommends the use of a second patient temperature
probe connected to Arctic Sun™ Temperature
Management System Temp In 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 System.
• 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 a 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. Possible skin injuries
include bruising, tearing, skin ulcerations, blistering,
and necrosis. 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.
• 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.
• 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, 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.
• 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 thermal injury.
• 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.
• 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.

3
English
The current Service Manual can be found at www.medivance.com/manuals
CAUTIONS (Continued)
• BD will not be responsible for patient safety or
equipment performance if the procedures to
operate, maintain, modify or service the Arctic Sun™
Temperature Management System are other than those
specified by BD. Anyone performing the procedures
must be appropriately trained and qualified.
• The clinician and/or operator is responsible for clinical
decisions based on Arctic Sun Work to Cool data
provided by the system. The displayed graphics are for
general information purposes only and are not intended
to replace standard medical record documentation for
use in therapy decisions. Anyone interpreting the Arctic
Sun Work to Cool data to make clinical decisions 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.
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 E).
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.
Fig 1-1 Arctic Sun™ Temperature Management System Control Module
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.
Serial
Number
Patient
Temp 1
RS232
Port
Ethernet
Port
Power
Switch
USB
Port
Fluid
Delivery
Line Port
Fill Tube
Parking
Patient
Temp 2
Patient
Temp
Out
Power
Cord
Air
Filter

4
Service Manual
System Navigation
Therapy Selection
Use the Therapy Selection screen to initiate a New Patient,
Continue a Current Patient, or access the Advanced Setup
screen.
Fig 1-4 Hypothermia therapy screen (using Adult ArcticGel™ pads)
7. Therapy Graph
E. Patient Temperature
F. Water Temperature
G. Date and Time
H. Progress Bar
8. Empty Pads
9. Fill Reservoir
10. Monitor Mode
11. Arctic Sun Work to Cool Trend
12. Control (Normothermia Screen)
Cooling (Hypothermia Screen)
13. Start/Stop
14. Adjust
15. Wi-Fi Connected (if enabled)
16. Rewarming (Hypothermia Screen)
Patient Pad Selection Screen
Once the therapy has been selected, the user will be
prompted with the Pad Selection screen. Select the
appropriate pad type based on the pads placed on the
patient.
Therapy Screens
The following information is displayed and functions are
available from the Normothermia and Hypothermia
therapy screens.
1. Therapy Selection (or Screen Lock)
2. System Access
3. Notification
4. Temperature Units (if enabled)
5. Patient Status
A. Patient Temperature
B. Patient Temperature 2 (if enabled)
6. System Status
C. Water Temperature
D. Flow Rate
Fig 1-2 Therapy Selection Screen
Fig 1-3 Pad Selection Screen
Fig 1-5 Normothermia therapy screen (using adult ArcticGel™ pads)

5
English
The current Service Manual can be found at www.medivance.com/manuals
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 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.
Fig 1-6 Fill Reservoir 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.
Fig 1-7 Manual Control Settings Screen
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 by pressing the
up arrow once and save your settings. Press close to
close the settings window.
4. From the therapy screen, press the Manual Control
button. 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. Set the Manual Control water target temperature to
4°C and the duration to 30 minutes.
10. 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
or colder.
11. Press the Stop button to stop Manual Control.
12. Press the Cancel button to close the Manual Control
window.
13. 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.
14. Power O the Control Module.

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Service Manual
Chapter 2- Components
Hydraulic Components
Fluid Delivery Line – reusable dual lumen tubing that
connects the Control Module to the ArcticGel™ Pads.
Pumps
Circulation Pump – pumps water from the Circulation
Tank through the ArcticGel™ Pads.
Mixing Pump – Transfers cold water from the Chiller
Tank to the Circulation Tank.
Chiller Pump – continuously circulates the water from
the Chiller Tank through the chiller’s evaporator.
Tanks
Circulation Tank – contains temperature-controlled
water that supplies the ArcticGel™ Pads.
Chiller Tank – contains water that is maintained at
approximately 4°C.
Supply Tank – contains water that is used to replenish
the Circulation Tank when the ArcticGel™ Pads are filled.
Sensors
Outlet Monitor Temperature - T1 – located within the
Circulation Tank. Used to monitor the temperature of
water that supplies the ArcticGel™ Pads.
Outlet Control Temperature - T2 – located within the
Circulation Tank. Used to control the temperature of
water that supplies the ArcticGel™ Pads.
Inlet Temperature – T3 – located within the Inlet/Outlet
Manifold. Monitors the temperature of water returning
from the ArcticGel™ Pads.
Chiller Temperature – T4 – located within the Chiller
Tank. Used to control temperature of water in the Chiller
Tank.
Pressure Sensor – located within the Inlet/Outlet
Manifold. Used to maintain a constant negative pressure
within the ArcticGel™ Pads by controlling the speed of
the Circulation Pump.
Flow Sensor – located at the outlet of the Circulation
Pump. Monitors the flow rate in the Circulation Circuit.
Valves
Conditioning Valve – located within the Inlet/Outlet
Manifold. When open, allows water to circulate internally
when priming or preconditioning.
Fill Valve – located within the Inlet/Outlet Manifold.
When open, allows the Circulation Pump to draw water
into the system.
Vent Valve – located within the Inlet/Outlet Manifold.
When open, allows air to supply ArcticGel™ Pads and the
displaced water to be returned to the Supply Tank.
Heater – located in the Circulation Tank. The heater
consists of 4 heating rods. The heating element within
each rod is in series with a non-resettable thermal fuse,
which protects each rod against an over-temperature
condition.
Inlet/Outlet Manifold – connects to Fluid Delivery Line
and Fill Tube. Contains the valves, the inlet temperature
sensor, and the pressure sensor.
Chiller – a refrigeration unit that continuously cools the
evaporator.
Electronic Components
Transmission Interface Module (T.I.M.) – an integrated
transmission interface module located on top of the
Card Cage converts real time data for transmission to a
hospital EMR system.
Cables – power cord and temperature cables. Additional
adapter cables are available to purchase for use with
different manufacturers’ temperature probes. In addition,
temperature out cables can be purchased to allow output
of patient temperature to an external monitor. Please
refer to the Temperature Cables in Appendix D.
Panel ESD Board – located on the connector panel
bracket. Provides electrical isolation for YSI 400
compatible patient temperature input/output signal.
AC PCB– located below the Supply Tank. Includes
electromechanical relays to control mains power to the
chiller and heater. Also includes solid state relays to
control power to each of the four heating elements.
Power Supply – located next to the AC PCB. Converts AC
mains voltage to 24 VDC.
Power Circuit Card – located within the Card Cage.
Converts 24 VDC to lower DC voltages used by the system.
The Processor Circuit Card – located within the
Card Cage. Includes both the control and monitor
microprocessors and associated circuitry, including
nonvolatile memory.
The Isolation Circuit Card – located within the Card
Cage. Provides electrical isolation for the Patient
Temperature circuits to a level of 1500V.
The Input/Output Circuit Card – located within the Card
Cage. Contains circuits that monitor water temperature,
pressure and flow. Provides control for Circulation and
Mixing Pumps, valves, and Chiller.
The Backplane Circuit Card – located at the back of the
Card Cage. Interconnects the circuit cards within the card
cage.
Control Panel – located at the top of the Control
Module. Consists of touch screen, microprocessor, hard
drive, USB interface, and USB-powered speaker.

7
English
The current Service Manual can be found at www.medivance.com/manuals
Chapter 3 – Theory of Operation
Main Hydraulic Circuits
Circulation Circuit – circulates temperature-controlled
water from the Circulation Tank through the ArcticGel™
Pads and returns to the inlet port of the Circulation Pump.
The speed of the Circulation Pump varies to maintain -7.0
PSI (0.5 bar) at the Pressure Sensor. Since water in the
ArcticGel™ Pads flows under negative pressure, a break in
the circuit, such as a pad being punctured or disconnected,
will result in air leaking into the system instead of water
leaking out. Air in the system is removed in the Circulation
Tank and exits through the tank vent. When warmer water
is required, the heaters located in the Circulation Tank
are energized. The heater power is dependent upon the
flow rate through the circulation tank and the difference
between the water temperature and the commanded
water temperature. The heater has four elements that are
cycled on sequentially to minimize power fluctuations in
the mains supply.
Chiller Circuit – maintains the water in the Chiller Tank
at approximately 4°C. Water is gravity-fed into the
centrifugal Chiller Pump and is then pumped through the
chiller’s evaporator and returned to the Chiller Tank. The
refrigerant system’s cooling capacity is controlled by a
refrigerant valve. When the Chiller Circuit approaches 4°C,
the cycling of the valve can be heard.
Mixing Circuit – when cold water is required to cool the
Circulation Circuit, the Mixing Pump pulls water from the
Circulation Tank and meters it into the Chiller Tank. Cold
water overflows from the Chiller Tank into the Circulation
Tank. The speed of the mixing pump is dependent
upon the flow rate through the circulation tank and
the difference between the water temperature and the
commanded water temperature.
Ancillary Hydraulic Circuits
Filling – When filling, the Fill Valve is opened, and water
is drawn up through the valve by the Circulation Pump.
Water returns through the Circulation Tank to the Supply
Tank. Negative Pressure must be generated at the inlet
of the Inlet/Outlet Manifold for filling to occur, therefore
the Fluid Delivery Line must be attached. ArcticGel™ Pads
should not be attached to the Fluid Delivery Line during
filling.
Preconditioning – The system can be programmed to
precondition water prior to initiating therapy. In this mode,
the Bypass Valve opens and allows temperature-controlled
water to circulate internally to bring the Circulation Tank
and Supply Tank water to a pre-programmed temperature.
Empty Pads – To empty water from the ArcticGel™ Pads,
the Vent Valve is opened, which enables air to enter the
pads. Water is pulled from the pads by the Circulation
Pump and returned through the Circulation Tank to the
Supply Tank.
Fig 2-1 Hydraulic Schematic
MIXING
PUMP
CHILLER
PUMP
CHILLER
TANK CIRCULATION TANK
CIRCU-
LATION
PUMP
EVAPORATOR
CHILLER AIR FLOWAIR FLOW
FLOW METER
SUPPLY TANK
CHILLER
CIRCUIT CIRCULATING CIRCUIT
INLET/OUTLET
MANIFOLD
ATMOSPHERE
HEATER T2T1
T4
DRAIN PORTS
VENT
FILL LINE
ARCTICGEL
PAD
BYPASS LINE FV
T3
P1
BV
VV
KEY
VV Vent Valve
BV Bypass Valve
FV Fill Valve
P1 Pressure Sensor
T1 Outlet Monitor Temperature
T2 Outlet Control Temperature
T3 Inlet Temperature
T4 Chiller Temperature
VALVE
FLUID
DELIVEY
LINE
VALVE
FLUID
DELIVERY
LINE

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Service Manual
Electronic Control System
The electronic system consists of two independent
subsystems: control and monitor. The control subsystem
is responsible for delivering therapy to the patient. The
monitor subsystem confirms the safe operation of the
control subsystem. Each subsystem has an independent
microprocessor, audio alarm, and both water and patient
temperature sensing circuits.
The control subsystem performs the following functions:
• Command interpretation from the Control Panel
• System information update to the Control Panel
• Circulation Tank water temperature control (T1 & T2)
• Circulation Pump speed control from pressure sensor (P1)
• Patient temperature measurement (PT1)
• Temperature Out signal generation
• Chiller Tank water temperature control (T4)
• Valve control (VV, BV and FV)
• Chiller control
The monitor subsystem performs the following functions:
• Redundant command interpretation from Control Panel
• Circulation Tank temperature monitoring (T1)
• Patient temperature measurement (PT2)
• Circulation Pump power interrupt control
• Power Circuit Card voltage monitoring
Chapter 4- Maintenance
Maintenance Schedule
Routine maintenance and service 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 Arctic Sun Cleaning Solution that suppresses
microorganism growth in the water reservoir and hydraulic
circuit.
Procedure Interval
Clean and disinfect external
surfaces After each use
Inspect Connectors and Cables 6 months
Clean the Condenser 6 months
Replenish Arctic Sun Cleaning
Solution 6 months
Inspect Screen Protector 6 months
Inspect Fluid Delivery Line 6 months
Inspect Manifold O-Rings 6 months
Calibration
Every 2000 hours or
250 uses, whichever
occurs first, as
indicated by system
display
Clean the External Surfaces
After use, the external surfaces of the Arctic Sun™
Temperature Management System may be a potential
biohazard. The Arctic Sun™ Temperature Management
System external surfaces should be manually cleaned,
disinfected and visually examined per the instructions below.
Prior to cleaning:
1. Use appropriate personal protective equipment
(e.g. gloves, eyewear, face mask or shields) per
manufacturer’s guidelines for the enzymatic spray
to protect user from exposure to both chemicals and
microorganisms.
2. Apply the castor brakes on the Arctic Sun™ Temperature
Management System.
3. Unplug the power cable from the wall outlet.
4. Straighten the power cable.
5. Disconnect all other cables and hoses from the Arctic
Sun™ Temperature Management System and straighten
them.
Manual Cleaning:
• Timing
Clean the Arctic Sun™ Temperature Management
System external surfaces as soon as practical after use
(e.g. at the point of use).
• Cleaning Materials
Required: Neutral-pH Enzymatic spray cleaner; clean,
dry cloths
Validated: Medline Bio-Zolve Instrument Presoak Spray
• Cleaning
1. Saturate a clean, dry cloth with the Enzymatic
cleaner and remove all heavy soil loads from the
external surfaces of the Arctic Sun™ Temperature
Management System.
2. Saturate a second clean, dry cloth with the
Enzymatic cleaner and thoroughly wipe all external
surfaces of the device.
a) Ensure that all surfaces are dampened,
including seams of the device.
b) Use as many additional clean cloths
saturated with the Enzymatic cleaner as
necessary to ensure device is completely
dampened.
c) Thoroughly wipe the following with
additional clean cloths saturated with the
Enzymatic cleaner – fluid delivery line,
power cable, temperature cables, USB cable,
RS232 cable.
3. Allow surfaces to remain treated for a minimum of two
(2) minutes.
4. Use a clean, dry cloth to remove remaining cleaning
solution.
Required accessories and supplies can be ordered separately.
Refer to Appendix D for the Spare Parts and Service Items.

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Surface Disinfection
Disinfect the Arctic Sun™ Temperature Management System
immediately following cleaning. Follow all manufacturers’
guidelines for the pre-saturated germicidal wipes, including
wearing gloves and other personal protective equipment
when dispensing and using the wipes.
Manual Disinfection:
• Disinfection Materials:
Required: Pre-saturated germicidal wipes (active
ingredient – alcohol)
Validated: Super Sani-Cloth Germicidal Disposable Wipe
• Disinfection
1. Using pre-saturated germicidal wipes, disinfect all
external surfaces of the Arctic Sun™ Temperature
Management System.
a) Ensure that all surfaces are dampened, including all
seams of the device.
b) Use as many clean towelettes as necessary to
ensure device is completely dampened with
disinfectant.
c) Thoroughly wipe the following with additional
clean towelettes – fluid delivery line, power cable,
temperature cables, USB cable, RS232 cable.
2. Allow the treated surfaces to remain wet for the
manufacturer’s specified contact time.
3. Wipe each surface of the device with a lint-free cloth
premoistened with sterile water.
4. Let air dry.
5. Reattach cables and hoses.
Visual Inspection and Return to Use
1. After cleaning and disinfecting the device per
the instruction provided, examine the device for
cleanliness. If visible soil remains, repeat manual
cleaning instructions.
2. Inspect cables and hoses for signs of damage.
3. Inspect external shell for discoloration or cracking.
4. Inspect labels for legibility.
5. Do not use the device if it has failed visual inspection
for soil after multiple cleaning attempts, or if there
is visible damage. Contact Customer Support for
additional recommendations.
6. Store the device in a dry and clean environment when
not in use.
Note: The device has been validated for exterior surface
cleaning and disinfection per the instructions provided.
Any deviation from the recommended parameters must
be validated by the user. Interior surface of the device
(including deep crevices) are not addressed as part of this
cleaning and disinfection protocol.
To prevent possible discoloration, do not use iodine-based
solutions, such as Betadine, on any part of the machine.
For questions on device cleaning and disinfection of
external surfaces contact BD Customer Support.
Inspect Connectors and Cables
Inspect the patient temperature cable(s) and power cord
for integrity. Ensure temperature cables are properly strain
relieved. Ensure power cord bracket is secure.
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 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 Solution
Contact Customer Service to order internal Arctic Sun
Cleaning Solution.
To replenish the internal Arctic Sun 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.
• Connect the fill tube.
• 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
second liter of sterile water.
• The filling process will automatically stop when the
reservoir is full. Continue to replace the bottles of
sterile water until the filling process stops.
• When the Fill Reservoir process is complete, the screen
will close.
Note: The reservoir level sensor requires a conductive fluid to
operate properly. Filling the reservoir without using the
Arctic Sun Cleaning Solution may result in overfilling
the reservoir.

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Service Manual
Inspect Screen Protector
The Control Panel’s touchscreen is supplied with a
disposable screen protector. If it becomes damaged, it can
be removed by lifting the edge and carefully peeling it from
the screen. To ensure dust and particulates are removed,
clean the touchscreen using isopropyl alcohol. Remove the
blue liner from the screen protector. Then carefully apply the
protector to the screen with the liner side down.
Inspect Fluid Delivery Line
1. Power On the system
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. Set the Manual Control water target temperature to
28°C and the duration to 30 minutes.
5. Connect a shunt to a set of fluid delivery line ports.
6. Press the System Access button on the Therapy screen
then press the Diagnostics button. Verify that inlet
pressure is -7 psi ± 0.2.
7. Repeat on all valves. If inlet pressure is out of range,
replace the two valves that the shunt is connected to.
8. Ensure that the shunt is removed before device is put
back in service.
Inspect Manifold O-Rings
Inspect the O-rings in the manifold. Ensure no cuts or tears
are present and that the rings make an intact seal with the
Fluid Delivery Line.
System Diagnostics
Select the System Access button on the Normothermia
therapy or Hypothermia therapy screen to access System
Diagnostics in order to verify pressures and flow rates
through the system.
Calibration
To perform a calibration on the Arctic Sun™Temperature
Management System, press the Advanced Setup button
on the Therapy Selection Screen. Press the Start button
and follow the on-screen directions. Refer to Chapter 9 for
additional instructions.
Functions
• Download Patient Data
• Connectivity Settings
• Calibration
• Total Drain
• Save All Settings As Default
Location / Time Settings
• Number Format
• Current Time
• Date Format
• Current Date
Information
• Software Versions
• Last Calibration Date
• Next Calibration Due
Fig 5-1 Advanced Setup Screen
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 button to the right
of the parameter.
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.
Note: The Advanced Setup button on the Patient Therapy
screen will be available when the unit is Powered On.
The Advanced Setup button will not be available
once patient therapy has been started. The Advanced
Setup button can only be redisplayed after cycling the
power.

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Download Patient Data
The data for the 10 most recent patient therapies is
stored on the Arctic Sun™ Temperature Management
System Control Module internal storage. The data may be
downloaded through the USB port to a flash drive. This
data is maintained when the Arctic Sun™ Temperature
Management System is Powered Off, or in the event of a
total loss of power.
To download patient data:
• Insert a flash drive into the USB port on the front of the
Control Module.
• From the Advanced Setup screen, press the Start
button to display the Download Patient Data window.
• Use the Up and Down arrows to select the patient data
file for download. Each patient data file is identified by
the date and time that the patient therapy ended.
• Press the Save button to initiate the download process.
The download process will indicate when the process is
complete by changing the color of the patient data file
text to gray.
• Remove the flash drive from the USB port.
• The data is saved as a text file to the flash drive’s
main directory. The file will be named according to the
following convention: Arctic Sun-Date-Time.csv
• See the following table for the contents of the data
file. During therapy, the values for each parameter are
saved every minute.
• Press the Cancel button to close the window.
Note: 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.
Patient Data Fields
Parameter Units
Date MM/DD/YY
Time HH:MM
Sequence starter indicator $
Sequence serial number Sequential integer beginning with
1 (initializing at Power On)
Patient Temperature 1 °C, 0 if probe not attached
Patient Temperature 2 °C, 0 if probe not attached
Patient Target Temperature °C
Operating Mode 0 = initialization
1 = Stop
2 = Patient Control
3 = Manual Control
4 = Empty Pads
5 = Fill Reservoir
6 = Monitor Mode (RS232)
8 = Monitor Mode
Diagnostic Mode 0 = Normal
1 = Diagnostic
Outlet Water Temperature (T1) °C
Outlet Water Temperature (T2) °C
Inlet Water Temperature (T3) °C
Chiller Water Temperature (T4) °C
Water Outlet Target Temperature °C
Temperature Display Units 0 =°C
1 =°F
Communications Output Mode Seconds
Current Alarm Number Integer
Flow Rate Liters/Minute
Reservoir Level Last Measured 0 = Empty
1 = Low
2 = ½
3 = ¾
4 = Full
5 = Full
Inlet Pressure Psi
Heater Power 0 – 32
Mixing Pump Power 0 – 200
Flow Pump Power 0 - 235
Control Power Mode 1, 2, 3
Software Version x.y (major revision)
Device Identifier* Globally unique ID
Arctic Sun Work to Cool* Watts
Bypass* 0 = Not engaged (closed)
1 – Engaged (open)
Vent* 0 = Not engaged (closed)
1 – Engaged (open)
Pump Hours* Hours
System Hours* Hours
Facility ID* Unique string identifying facility
Arctic Sun Work to Cool Threshold* Watts
Upper Temp Threshold for Monitor
Mode*
°C
Lower Temp Threshold for Monitor
Mode* °C
ArcticGel Pad Size* Adult
Pediatric
Neonate
* Indicates data is included in Wi-Fi data only

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Service Manual
Connectivity Settings
Use Connectivity Settings to connect the Arctic Sun™
Temperature Management System to the hospital network
connection. This optional feature allows therapy data from
the Arctic Sun™ Temperature Management System to be
sent wirelessly.
To connect:
• From the Advanced Setup screen, press the Start
button to display the Connectivity Settings window.
• From the Device tab, select Configure.
• Select Configure under the Device ID tab and enter
the serial number, located on the back of the device.
• Press the Continue button once the Device ID has
been entered.
• Re-enter the Device ID and press the Confirm button
to confirm
• Select Edit/View under the Facility ID tab and enter
the name of the facility where the device is located.
• Press the Continue button once the Facility ID has
been entered.
• Close the Device Configuration screen.
• From the Network tab, press the Connect button
• Select the desired Network to connect with from the
list.
• Enter network password and select Continue
• From the Server tab, select Configure.
• Select Configure under the Server Address tab and
enter the account Server Address and press Continue.
• Select Configure under the Server Port Number tab
and enter the account Server Address Number and
press Continue.
• Select Start under the Test Connection tab to verify if
the connection to the server is successful
• Select Edit under the Encryption Password tab to enter
an encryption passphrase.
• Enter the passphrase and press Continue.
Note: If wireless connectivity is lost, therapy will continue
uninterrupted. Any therapy data generated while
wireless connectivity is lost will automatically be sent
upon reconnection unless a new therapy is started
or the device is powered off for more than six hours
before connection is reestablished. Therapy data that
is not transmitted can be retrieved via USB.
Maximum network latency: 500 ms
Hourly data throughput: ~18 kb
Integrity of data in transit: TCP/IP protocol
Wireless security protocol: WPA2 Personal
Calibration
Calibration is recommended after 2,000 hours of
operation or 250 uses, whichever occurs first as
indicated on the display screen. Calibration instructions
are stored in the device and can be accessed from the
calibration screens on the Advanced Setup Screen.
Calibration should be done only by trained service
personnel.
Total Drain
The Arctic Sun™ Temperature Management System needs
to be totally drained of water prior to shipping or exposure
to subfreezing temperatures to prevent damage.
• Turn Control Module Power Off.
• Attach the drain line connectors to the two drain
ports on the back of the Control Module. The water
will passively drain into the bag.
• Perform the following steps to run the device pumps
and further expel water from the system.
• Plug in the Control Module and Power On.
• From the Advanced Setup screen, press the Start
button next to Total Drain. The Total Drain pop up
window will display.
• Press the Drain button on the window to initiate
the drain cycle. The text in the window will change
to notify the user that the pumps are running and
draining the device.
• The drain cycle should complete in approximately 30
seconds.
• Press the Cancel button to exit the screen when the
process is complete.
Save Settings as Default
The Save all Settings as Default option will save all
of the Advanced Setup settings. The system default is
Normothermia and Hypothermia. Two additional settings
can be added.
• From the Advanced Setup screen, press the Start
button next to Save All Settings as Default.
• The device allows for two additional default settings
of Normothermia or Hypothermia.
• The additional default settings may be added by
pressing the appropriately labeled button. Once
selected, you will automatically be taken back to the
Advanced Setup Screen. Press Close and return to
the patient Therapy Selection screen.
• Select the recently added default on the patient
Therapy Selection screen. The settings will
automatically be the same as the standard defaults.
Adjust settings as desired.
• Return to the patient Therapy Selection Screen and
press Advanced Setup.
• Select Save All Settings as Default.
• Press Save to store new default on the Arctic Sun™
Temperature Management System.
• To remove default from the Arctic Sun™ Temperature
Management System, press the trash icon.
• Close the Advanced Setup Screen.
Note: Selecting the Close button without saving will retain
the previous default configuration.

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Number Format
• To set the number format to the local requirements:
• From the Advanced Setup screen, press the button the
right of the Number Format parameter.
• Use the Up and Down arrows to select the number
format.
Range: 1,234.5
1.234,5
• Press the Save button to save the new setting and
close the window.
• Press the Cancel button to close the window without
saving the new setting.
Current Time
To set the current local time in 24-hour notation:
• From the Advanced Setup screen, press the button to
the right of the Current Time parameter.
• Use the Up and Down arrows to set the hours.
Range: 00 to 23
• Use the Up and Down arrows to set the minutes.
Range: 00 to 59
• Press the Save button to save the new setting and
close the window.
• Press the Cancel button to close the window without
saving the new setting.
Note: Making changes to the date or time during an
active patient therapy will automatically stop the
therapy. Wait until the current patient therapy
has ended before making any adjustments to this
feature.
Date Format
• To set the date format to the local requirements:
• From the Advanced Setup screen, press the button to
the right of the Date Format parameter.
• Use the Up and Down arrows to select the date format.
Range: MM/DD/YY
DD/MM/YY
DD/MM/YYYY
• Press the Save button to save the new setting and
close the window.
• Press the Cancel button to close the window without
saving the new setting.
Current Date
To set the current local date:
• From the Advanced Setup screen, press the button to
the right of the Current Date parameter.
• Use the Up and Down arrows to set the Day.
Range: 01 to 31 (depending on month)
• Use the Up and Down arrows to set the Month.
Range: 01 to 12
• Use the Up and Down arrows to set the Year.
Range: 2018 to 2099
• Press the Save button to save the new setting and
close the window.
• Press the Cancel button to close the window without
saving the new setting.
Note: Making changes to the date or time during an
active patient therapy will automatically stop the
therapy. Wait until the current patient therapy
has ended before making any adjustments to this
feature.
Software Versions
The current controller and graphics software versions
installed on the device are displayed.
Last Calibration Date
The last calibration date of the device is displayed.
Next Calibration Due
The next calibration date of the device is displayed in
number of uses and hours.

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Service Manual
Chapter 6 - Alarms
The Arctic Sun™ Temperature Management System
safety system continually monitors the state of the device
and the patient, and issues alarms to notify the user of
conditions that may interfere with patient safety or system
performance.
Main Safety Alarms
While there are multiple alarms and safety features in the
Arctic Sun™ Temperature 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
Medium Priority Alarms
A Medium Priority Alarm is denoted by an audio signal
that repeats every 10 to 15 seconds until the Alarm is
cleared. The yellow 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 acknowledged
by the operator within 2 minutes, a Reminder tone will
sound. All Alarm settings are maintained in the event of a
power interruption.
A Medium Priority Alarm notifies the
user a condition that may potentially
pose discomfort or reversible injury to
the patient requires operator response.
Failure to respond may result in
irreversible injury or death.
Note: The system and any ongoing
therapy will be placed in Stop mode.
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
simulates 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 appropriately either an
alarm 80 or 81 will be issued. Contact BD Customer Support.
If power is unexpectedly lost, the device will beep to notify
the user. Upon restoration of power, the device will issue
alarm 45.
There are two types of conditions: Medium Priority Alarms
and Low Priority Alarms.
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 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:
• When an alarm is issued the device is placed into Stop
mode.
• Read the displayed instructions.
• Note the Alarm number.
• Press the Close button to clear the alarm.
• Follow the instructions to correct the alarm condition.
Perform the actions in the order listed until the alarm
condition is resolved.
• 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”.
If the condition does not resolve, contact Customer Support.
A Low Priority Alarm notifies the user
a condition that may potentially pose
discomfort or reversible injury to the
patient requires operator response.
Low Priority Alarms
A Low Priority Alarm is denoted by an audio signal that
repeats every 25 to 30 seconds. The blue Alarm screen
will appear that displays the alarm number, alarm title, a
description of the problem that triggered the alarm, and
solutions and instructions for troubleshooting and resolving
the alarm condition.
If a Low Priority Alarm occurs:
• Read the displayed instructions.
• Note the Alarm number.
• Press the Close button to clear the alarm.
• Follow the instructions to correct the alarm condition.
Perform the actions in the order listed until the alarm
condition is resolved. If the condition does not resolve,
contact BD Customer Support.
Notes: If the condition that initiated the alarm is not
addressed and the problem persists, the Alarm will recur
and/or escalate.
To view alarms, the operator should stand in front of the
Arctic Sun™ Temperature Management System display
screen.

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Alarms Listing
The following table consists of a listing of the medium and low priority alarms that a user might
observe during use of the Arctic Sun™ Temperature Management System.
Alarm Problem Solution
00 Communications
Failure
Medium Priority Alarm
Communications to control panel
have failed upon power up
1. Turn Control Module Off. Wait 30 seconds and turn Control Module On.
2. If alarm persists, contact BD Customer Support.
01 Patient Line Open
Low Priority Alarm
The system is detecting that the fluid
delivery line or patient line is open to
air or has significant air in the line.
The fluid pump is working at the
expected speed but the flow rate is
less than 1 liter per minute and the
fluid pressure is less than -6 psi.
1. Check that patient line connectors are fully seated in the fluid delivery line
manifold. If indicated, reseat connectors.
2. Check patient line connectors for damage that prevents connector from
properly seating / sealing with manifold. If connector damage found,
replace pad.
3. Check pads for leaks. Disconnect one pad at a time from the manifold
to determine if one pad is contributing to the air leak or low flow. Wait a
minimum of 45 seconds for the air to clear the line and then check to see if
the flow has increased. If faulty pad found, replace faulty pad.
4. To check whether a valve is leaking, reinstall the pad into a different location
on the fluid delivery line manifold and wait a minimum of 45 seconds again.
02 Low Flow
Low Priority Alarm
The flow rate is less than 50% of the
maximum flow rate measured since
the last Power On or Empty Pads,
or the flow rate is less than 300 ml/
minute.
1. Check that patient line connectors are fully seated in the fluid delivery line
manifold. If indicated, reseat connectors.
2. Check patient line connectors for damage that prevents connector from
properly seating / sealing with manifold. If connector damage found,
replace pad.
3. Check that pad lines are not kinked.
4. Check pads for leaks. Disconnect one pad at a time from the manifold
to determine if one pad is contributing to the air leak or low flow. Wait a
minimum of 45 seconds for the air to clear the line and then check to see if
the flow has increased. If faulty pad found, replace faulty pad.
5. To check whether a valve is leaking, reinstall the pad into a different location
on the fluid delivery line manifold and wait a minimum of 45 seconds again.
03 Water Reservoir Low
Low Priority Alarm
At Power On or the end of the Empty
Pads cycle or the Fill Reservoir cycle,
the system fluid level sensors are
detecting that the water reservoir is
low. There is only enough water in the
reservoir to run one patient therapy.
1. Pads may not have been emptied prior to powering down. Empty pads to
reestablish the volume of water in the system.
See VI. Operation Guide-Therapy Screens-Empty Pads for instructions.
2. Fill the water reservoir.
See VI. Operation Guide-Therapy Screens-Fill Reservoir for instructions.
04 Water Reservoir
Below Minimum
Medium Priority Alarm
At the end of the Empty Pads cycle,
the system fluid level sensors are
detecting that the water reservoir is
empty or below the minimum level
required to operate the system.
1. Pads may not have been emptied prior to powering down. Empty pads to
reestablish the volume of water in the system.
See VI. Operation Guide-Therapy Screens-Empty Pads for instructions.
2. Fill the water reservoir.
See VI. Operation Guide-Therapy Screens-Fill Reservoir for instructions.
05 Water Reservoir
Empty
Medium Priority Alarm
At Power On or the end of the Empty
Pads cycle, the system fluid level
sensors are detecting that the water
reservoir is empty or below the
minimum level required to operate
the system.
Fill the water reservoir.
See VI. Operation Guide-Therapy Screens-Fill Reservoir for instructions.
07 Empty Pads Not
Complete
Low Priority Alarm
A significant amount of water was still
being returned from the pads at the
end of the Empty Pads cycle.
1. The pads may still contain a significant amount of water. Use caution when
disconnecting pads to avoid spilling water. The system can continue to be
used without further action.
2. Check reservoir level. Reservoir may have been overfilled. If reservoir level
full:
a. Power Off system.
b. Drain approximately 1 liter of water from the drain
port.
c. Power On system.
d. Repeat Empty Pads.
3. Contact BD Customer Support if problem persists.
Low Priority Alarm
Medium Priority Alarm

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Service Manual
Alarm Problem Solution
08 Patient Temperature
1 High
Medium Priority Alarm
The Patient Temperature 1 reading
is above 39.5°C (103.1°F), and
the water temperature is above
39.5°C (103.1°F), and the system is
continuing to warm the patient when
the system is in a patient control
mode (e.g. Control Patient, Cooling or
Rewarming).
1. Verify Patient Temperature Accuracy
Confirm patient temperature using a secondary site.
Confirm that the primary temperature probe is properly placed
and registering an accurate temperature.
2. Verify Patient / Water Temperature Control
Observe patient temperature
Is the patient temperature decreasing?
Observe water temperature.
Is the water temperature <39.5°C (103.1°F)?
Is the water temperature decreasing?
If the water and/or patient temperatures are beginning to
decrease, the system is working correctly. Continue to monitor
patient temperature.
3. Verify Water Temperature Limits
In Normothermia Settings or Hypothermia Settings, confirm
that the water temperature low limit is set ≤10°C (50°F).
If necessary, set water temperature low limit ≤10°C (50°F).
Resume therapy.
Monitor water temperature and patient temperature.
If the water and/or patient temperatures are beginning to
decrease, the system is working correctly. Continue to monitor
patient temperature.
4. Verify Water Cooling – External Factors
Check environmental conditions that may affect cooling.
• Are the machine vents blocked?
• Is the room temperature too high?
• Is the oxygen heated?
• Are there hot lights or heating blankets on the
patient?
Remove any impediments.
Monitor water temperature and patient temperature.
If the water and/or patient temperatures are beginning to
decrease, the system is working correctly. Continue to monitor
patient temperature.
5. Verify Water Control – System Performance
Place unit in Manual mode, with water temperature set
<38°C (100.4°F).
Monitor water temperature and patient temperature.
If the water temperature is not decreasing to the commanded
temperature, the water cooling system is not working. Call BD
Customer Support.
If the water temperature decreases to the commanded
temperature, the water cooling system is working.
6. Verify Patient Control – System Performance
Place system back into the patient control mode.
Monitor water temperature and patient temperature.
If the water and/or patient temperatures are continuing to
decrease, the system is working correctly. Continue to monitor
patient temperature.
If the water temperature and/or patient temperatures are not
decreasing, call BD Customer Support.
09 Patient Temperature
1 Above High Patient
Low Priority Alarm
In Normothermia Therapy: The
Patient Temperature 1 reading is
above the High Patient Alarm setting
in Normothermia Settings.
In Hypothermia Therapy: The Patient
Temperature 1 reading is above
the High Patient Alarm setting in
Hypothermia Settings.
If desired, adjust the High Patient Alarm setting in Normothermia Settings or
Hypothermia Settings.

17
English
The current Service Manual can be found at www.medivance.com/manuals
Alarm Problem Solution
10 Patient Temperature
1 Low Medium Priority
Alarm
The Patient Temperature 1 reading
is below 31°C (87.8°F), and the water
temperature is below 31°C (87.8°F),
and the system is continuing to cool
the patient when the system is in a
patient control mode (e.g. Control
Patient, Cooling or Rewarming).
1. Verify Patient Temperature Accuracy
Confirm patient temperature using a secondary site.
Confirm that the primary temperature probe is properly placed
and registering an accurate temperature.
2. Verify Patient / Water Temperature Control
Observe patient temperature.
Is the patient temperature increasing?
Observe water temperature.
Is the water temperature >31°C (87.8°F)?
Is the water temperature increasing?
If the water and/or patient temperatures are beginning to
increase, the system is working correctly. Continue to monitor
patient temperature.
3. Verify Water Temperature Limits
In Normothermia Settings or Hypothermia Settings, confirm
that the water temperature high limit is set ≥36°C (96.8°F).
If necessary, set water temperature high limit ≥36°C (96.8°F).
Resume therapy.
Monitor water temperature and patient temperature.
If the water and/or patient temperatures are beginning to
increase, the system is working correctly. Continue to monitor
patient temperature.
4. Verify Water Control – System Performance
Place unit in Manual mode, with water temperature set
>38°C (100.4°F).
Monitor water temperature and patient temperature.
If the water temperature is not increasing to the commanded
temperature, the water heating system is not working. Call BD
Customer Support.
If the water temperature increases to the commanded
temperature, the water heating system is working.
5. Verify Patient Control – System Performance
Place system back into the patient control mode.
Monitor water temperature and patient temperature.
If the water and/or patient temperatures are continuing to
increase, the system is working correctly. Continue to monitor
patient temperature.
If the water temperature and/or patient temperatures are not
increasing, call BD Customer Support.
11 Patient Temperature
1 Below Low Patient
Low Priority Alarm
In Normothermia Therapy: The
Patient Temperature 1 reading is
below the Low Patient Alarm setting
in Normothermia Settings.
In Hypothermia Therapy: The Patient
Temperature 1 reading is below
the Low Patient Alarm setting in
Hypothermia Settings.
If desired, adjust the Low Patient Alarm setting in Normothermia Settings or
Hypothermia Settings.
12 Patient Temperature
1 High
Low Priority Alarm
The Patient Temperature 1 reading is
above 39.5°C (103.1°F), and the water
temperature is above 39.5°C (103.1°F)
when the system is in Manual Control
mode.
Patient temperature is not
automatically controlled while in
Manual Control mode
Decrease Manual Mode water target temperature to a setting that is ≤ 38.5°C
(101.3°F).
See VI. Operation Guide–Therapy Settings–Manual Control for further
instructions.
13 Patient Temperature
1 Low
Low Priority Alarm
The Patient Temperature 1 reading
is below 31°C (87.8°F), and the water
temperature is below 31°C (87.8°F)
when the system is in Manual Control
mode.
Patient temperature is not
automatically controlled while in
Manual Control mode
Increase Manual Mode water target temperature to a setting that is ≥ 32°C
(89.6°F).
See VI. Operation Guide–Therapy Settings–Manual Control for further
instructions.