Medivance BD Arctic Sun 6000 User manual

14868

Operator’s Manual
2
tube

Operator’s Manual
TABLE OF CONTENTS
I. SYMBOLS ................................................ 4
II. WARNINGS AND CAUTIONS
DEFINITION .................................................... 8
III. SAFETY PRECAUTIONS ...................... 9
WARNINGS ........................................ 9
CAUTIONS ......................................... 9
COMPLICATIONS ........................... 10
IV. INTRODUCTION .................................. 11
TECHNICAL DESCRIPTION ......... 11
INDICATIONS FOR USE ................ 11
SPECIFICATIONS ........................... 11
SYSTEM COMPONENTS .............. 12
V. SETUP PROCEDURE ......................... 14
UNPACK ........................................... 14
CONNECTIONS ............................... 14
POWER ON ...................................... 14
FILL RESERVOIR ............................ 14
FUNCTIONAL VERIFICATION ...... 14
VI. OPERATION GUIDE ............................ 15
THERAPY PREPARATION ............ 15
Place ArcticGel™ Pads ............... 15
Connect ArcticGel™ Pads ........... 15
Patient Placement ......................... 15
Temperature Probe Placement .. 15
THERAPY SELECTION .................. 15
New Patient–Normothermia ........ 15
New Patient–Hypothermia ........... 15
Confirm New Patient .................... 15
Current Patient .............................. 15
PATIENT PAD SELECTION .......... 15
THERAPY SCREENS ..................... 16
INITIATE THERAPY ........................ 23
INTERRUPT THERAPY FOR
PATIENT TRANSPORT .................. 24
END THERAPY ................................ 24
THERAPY SETTINGS .................... 25
ADVANCED SETUP ........................ 29
VII. ALARMS ................................................ 32
MEDIUM PRIORITY ALARMS ....... 32
LOW PRIORITY ALARMS .............. 32
VIII. TROUBLESHOOTING ......................... 33
WATER .............................................. 33
Water Not Cooling ........................ 33
Water Not Warming ...................... 33
Extended Cold Water Exposure . 33
Extended Warm Water Exposure
......................................................... 34
Low Water Flow ............................ 34
PATIENT TEMPERATURE ............ 34
Patient Not Controlling ................ 34
No Patient Temperature Display 35
SCREEN ........................................... 35
Screen Locked ............................. 35
Wireless Connection Lost ........... 35
IX. CLEANING AND DISINFECTION ..... 36
SURFACE CLEANING ................... 36
SURFACE DISINFECTION ........... 36
VISUAL INSPECTION AND
RETURN TO USE ........................... 36
X. MAINTENANCE AND SERVICE ....... 37
INSPECT CONNECTORS AND
CABLES ............................................ 37
CONDENSER .................................. 37
DEVICE INSPECTION ................... 37
REPLENISH INTERNAL SOLUTION
........................................................... 37
INSPECT SCREEN PROTECTOR37
INSPECT FLUID DELIVERY LINE 37
INSPECT MANIFOLD O-RING ..... 37
SYSTEM DIAGNOSTICS .............. 37
SERVICE .......................................... 38
CALIBRATION ................................. 38
XI. PREVENTATIVE MAINTENANCE .... 38
XII. CUSTOMER SUPPORT ..................... 38
APPENDIX A: ELECTROMAGNETIC
COMPATIBILITY .......................................... 39
APPENDIX B: ALARMS .............................. 41
APPENDIX C: WARRANTY ....................... 55

Operator’s Manual
4
I. SYMBOLS
The Arctic Sun™ Temperature Management System and its packaging bear the following symbols:
Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
ISO 15223-1
Reference no. 5.1.1
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Manufacturer
Indicates the medical
device manufacturer.
ISO 15223-1
Reference no. 5.1.3
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Date of manufacture
Indicates the date when
the medical device was
manufactured.
ISO 15223-1
Reference no. 5.1.4
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Use-by date
Indicates the date after
which the medical device
is not to be used.
ISO 15223-1
Reference no. 5.1.5
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Batch code
Indicates the
manufacturer's batch
code so that the batch or
lot can be identified.
ISO 15223-1
Reference no. 5.1.6
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Catalogue number
Indicates the
manufacturer's catalogue
number so that the
medical device can be
identified.
ISO 15223-1
Reference no. 5.1.7
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Serial number
Indicates the
manufacturer’s serial
number so that a specific
medical device can be
identified.
ISO 15223-1
Reference no. 5.3.7
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Temperature limit
Indicates the temperature
limits to which the
medical device can be
safely exposed.
ISO 15223-1
Reference no. 5.3.8
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Humidity limitation
Indicates the range of
humidity to which the
medical device can be
safely exposed.
ISO 15223-1
Reference no. 5.3.9
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Atmospheric pressure
limitation
Indicates the range of
atmospheric pressure to
which the medical device
can be safely exposed.
ISO 15223-1
Reference no. 5.4.2
Medical Devices-
Symbols to be used with
medical device labels,
labelling and information
to be supplied
Do not re-use
Indicates a medical
device that is intended
for one use, or for use on
a single patient during a
single procedure.

The current Operator’s Manual can be found at www.medivance.com/manuals English
5
Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
IEC TR 60878
Reference ISO
7010-M002
Graphical Symbols for
Electrical Equipment in
Medical Practice
Refer to instruction
manual/booklet
To signify that the
instruction
manual/booklet must be
read.
IEC TR 60878
Reference no. 6050
Graphical Symbols for
Electrical Equipment in
Medical Practice
Model number
To identify the model
number or type number
of a product. In the
application of this
symbol, the model
number or type number
of the product should be
accompanied with this
symbol.
IEC TR 60878
Reference no.5334
Graphical Symbols for
Electrical Equipment in
Medical Practice
Defibrillation-proof
type BF applied part
To identify a
defibrillation-proof type
BF applied part
complying with IEC
60601-1.
IEC TR 60878
Reference no. 5041
Graphical Symbols for
Electrical Equipment in
Medical Practice
Caution, hot surface
To indicate that the
marked item can be hot
and should not be
touched without taking
care.
IEC TR 60878
Reference no. 0029
Graphical Symbols for
Electrical Equipment in
Medical Practice
Draining; emptying
To indicate the emptying
of any vessel, or
container of liquid or
produce, for example
draining of oil tanks,
draining ink reservoirs, or
emptying grain hoppers.
IEC TR 60878
Reference no. 0028
Graphical Symbols for
Electrical Equipment in
Medical Practice
Filling
To indicate the filling of a
vessel or container by
any type of liquid or
produce, for example
filling of oil tanks, filling
ink reservoirs, filling grain
hoppers.
IEC TR 60878
Reference ISO
7010-W012
Graphical Symbols for
Electrical Equipment in
Medical Practice
Warning; Electricity
To warn of electricity.
IEC TR 60878
Reference 7010-
P017
Graphical Symbols for
Electrical Equipment in
Medical Practice
No pushing
To prohibit pushing
against an object.
IEC TR 60878
Reference 7010-
W001
Graphical Symbols for
Electrical Equipment in
Medical Practice
General Warning Sign
To signify a general
warning.
IEC TR 60878
Reference no. 5007
& 5008
Graphical Symbols for
Electrical Equipment in
Medical Practice
Power On/Off
Indicates power on/off
switch

Operator’s Manual
6
Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
IEC TR 60878
Reference no. 5021
Graphical Symbols for
Electrical Equipment in
Medical Practice
Equipotentiality
To identify the terminals
which, when connected
together, bring the
various parts of an
equipment or of a system
to the same potential, not
necessarily being the
earth (ground) potential,
e.g. for local bonding.
IEC TR 60878
Reference no. 2794
Graphical Symbols for
Electrical Equipment in
Medical Practice
Packaging Unit
To indicate the number of
pieces in the package.
IEC TR 60878
Reference no. 0623
Graphical Symbols for
Electrical Equipment in
Medical Practice
This way up
On transport packaging.
To indicate the correct
upright position.
IEC TR 60878
Reference no. 0621
Graphical Symbols for
Electrical Equipment in
Medical Practice
Fragile; handle with
care
On transport packaging.
To indicate the content of
the package is fragile
and that the package
must be handled with
care.
IEC TR 60878
Reference no. 0626
Graphical Symbols for
Electrical Equipment in
Medical Practice
Keep away from rain
Indicates a medical
device that needs to be
protected from moisture.
Directive
2002/96/EC
(WEEE)
Marking of electrical and
electronic equipment in
accordance with Article
11(2) of Directive
2002/96/EC (WEEE)
Waste Stream
Disposal Status
Do not dispose of
electronic products in the
general waste stream
21CFR801.15
Labeling; Prescription
devices
Prescription Use Only
Caution: Federal Law
(USA) restricts this
device to sale by or on
the order of a physician.

The current Operator’s Manual can be found at www.medivance.com/manuals English
7
Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
AAMI ES 60601-1
IEC 60601-1-8
IEC 60601-10
IEC 806012-35
CSA C22.2 No.
6060101
Medical electrical
equipment-Part 1:
General requirements for
basic safety and
essential performance
ETL Monogram
Per ETL Intertek, models
of the ARCTIC SUN™
Temperature
Management System
that bear the ETL
Monogram confirm to
AAMI ES60601-1, IEC
60601-1-8, IEC 60601-
10, IEC 80601-2-35 and
are certified to CSA
C22.2 No. 60601-1.
ISO 7000
Reference no. 3650
Graphical symbols for
use on equipment
Universal Serial Bus
(USB), port/plug
To identify a port or plug
as meeting the generic
requirements of the
Universal Serial Bus
(USB). To indicate that
the device is plugged into
a USB port or is
compatible with a USB
port.
IEC 60417
Reference no. 5850
Graphical symbols for
use on equipment
Serial interface
To identify a connector
for a serial data
connection
N/A
N/A
N/A
Indicates that only sterile
water should be used
when filling the ARCTIC
SUN™ Temperature
Management System
Control Module.
1
N/A
N/A
N/A
Identifies Patient
Temperature 1, the
patient temperature
probe input for
monitoring and control.
2
N/A
N/A
N/A
Identifies Patient
Temperature 2, the
patient temperature
probe input for
monitoring.
N/A
N/A
N/A
Identifies Patient
Temperature Out, the
patient temperature
output to an external
hospital monitor.
N/A
N/A
N/A
Identifies mechanical
hazard
N/A
N/A
N/A
Do Not Discard

Operator’s Manual
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Symbol
Standard Reference
Standard Title
Symbol Title
Explanatory Text
N/A
N/A
N/A
To identify the number to
call for urgent clinical
support. The number
shall be placed adjacent
to the symbol.
N/A
N/A
N/A
Plug Type
II. WARNINGS AND CAUTIONS DEFINITION
WARNINGS and CAUTIONS throughout the manual should be carefully reviewed before and during use of the device.
WARNING
Informs the reader about a situation which, if not avoided, could result in death or
serious injury. It may also describe potential serious adverse reactions and safety
hazards.
CAUTION
Informs the reader about a situation which, if not avoided, could result in minor or
moderate injury to the user or patient of damage the device or other property. This
includes special care necessary for the safe and effective use of the device and the
care necessary to avoid damage to a device that may occur as a result of use or
misuse.

The current Operator’s Manual can be found at www.medivance.com/manuals English
9
III. SAFETY PRECAUTIONS
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.
• 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.

Operator’s Manual
10
• CAUTIONS (Continued)
• 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.
• 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.

The current Operator’s Manual can be found at www.medivance.com/manuals English
11
IV. INTRODUCTION
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).
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 A for the full declaration regarding electromagnetic
compatibility.
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.
SPECIFICATIONS
Environmental Conditions
At operating temperatures higher than 27°C (80.6°F), the
refrigeration system’s cooling capacity and therefore its ability
to cool a patient is compromised.
If the Control Module is to be exposed to subfreezing
temperatures, perform the Total Drain process. See section VI.
Operation Guide–Advanced Setup–Total Drain for further
instructions.
Disposal
Upon end of life, dispose of in accordance with local WEEE
regulations or contact your local BD Supplier or Distributor to
arrange for disposal.
Parameter
Specification
Therapy Modes
Normothermia: Control Patient,
Rewarming
Hypothermia: Cooling, Rewarming
Heater Maximum Power
814 Watts
Circulating Fluid
Sterile Water with Cleaning Solution
Average Reservoir Capacity
3.5 liters
Patient Probe Type
YSI 400 Series compatible
Patient Temperature Inputs
Temp In 1: control, monitor, alarm
Temp In 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/50°F to 89.6°F)
±0.2°C (32°C to 38°C/89.6°F to 100.4°F)
±0.4°C (38°C to 44°C/100.4°F to
111.2°F)
Excludes external probe
Responses of the PCLCS
(Physiologic Closed-Loop
Control System)
Settling Time: ~4.5 hours
Relative Overshoot: <0.5°C
Command Overshoot: <0.5°C
Warming (max) Response Time:
32°C to 37°C/91.4°F to 98.6°F: ~8.5
hours
Cooling Response Time:
37°C to 33°C/98.6°F to 91.4°F: ~2 hours
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 44°C/37.4°F to 111.2°F
0.1°C /°F increments
Water Temperature Control
Range (Manual)
4°C to 40°C
1°C increments
High Water Temperature Limit
36°C to 40°C
1°C increments
Low Water Temperature Limit
4°C to 25°C
1°C increments
Time to heat water from 25°C to
40°C
<15 minutes
Time to lower water
temperature from 25°C to 7°C
<15 minutes
Sound Pressure
Low Priority Alarm: 64-71dB at 1 meter
Medium Priority Alarm: 64-71dB at 1
meter
Reminder Tone: 65dB at 3 meters
Mains Input
120VAC 60Hz 11Amp
Total Patient Leakage Current
(Normal Condition)
<300 μA
Operating Relative Humidity
Range
5% to 70% non-condensing
Storage and Transport Relative
Humidity Range
5% to 95% non-condensing
Operating Temperature Range
15.5°C to 32.2°C/59.9°F to 90.0°F
Storage and Transport
Temperature Range
-30°C to 50°C/-22°F to 122°F
Atmospheric Pressure Range
60 kPa to 101 kPa
Dimensions
Height: 41 inches (104 cm)
Width: 16 inches (41 cm)
Depth: 20 inches (51 cm)
Weight
Filled: 55.3 kg/122 lbs

Operator’s Manual
12
SYSTEM COMPONENTS
Figure IV-1. Product illustration
Control Module
The Arctic Sun™ Temperature Management System Control
Module is the main component of the Arctic Sun™
Temperature Management System. It incorporates the system
electronics, hydraulics, software, and the touch-screen Control
Panel. The power cord, fluid delivery line, patient temperature
in cables, patient temperature out cable and fill tube connect to
the rear of the Control Module. The figure above identifies the
main features and component connection sites. Use only BD
supplied cables and accessories with Arctic Sun™
Temperature Management System Control Module. The use of
accessories, transducers or cables other than those specified
may result in increased electromagnetic compatibility (EMC)
emissions or decreased immunity of the Arctic Sun™
Temperature Management System Control Module.
Power Cord
Hospital-grade power cords are available with several inlet
connector styles to meet national/regional power requirements
and wall outlet specifications.
Fluid Delivery Line
Water flows between the ArcticGel™ pads and Control Module
through the Fluid Delivery Line.
Fill Tube
A Fill Tube is used to fill the Control Module water reservoir.
Arctic Sun Cleaning Solution
Arctic Sun Cleaning Solution is added when filling the Control
Module with Sterile Water. This is done to suppress
microorganism growth in the water reservoir and hydraulic
circuit.
For information regarding safe handling, please refer to
http://www.medivance.com/manuals for the Cleaning Solution
SDS.
Patient Temperature Input Cables and Probes
Patient temperature control with the Arctic Sun™ Temperature
Management System requires patient temperature feedback
provided by an indwelling patient temperature probe connected
to the Control Module via the Temp In 1 and Temp In 2 inputs.
Any commercially-available Yellow Springs Instrument 400
Series (YSI 400) compatible patient temperature probe can be
connected to the Arctic Sun™ Temperature Management
System.
The Arctic Sun™ Temperature Management System
temperature cables are available with several connector styles
(e.g. Phillips, GE, Rusch, Bard, Nellcor) for compatibility with
various manufacturers’ temperature probes. Select the patient
temperature cable with the correct connector style for your
chosen temperature probe.
Figure IV-2. Temperature input cables
A temperature cable and probe connected to the Temp In 1
connector provides the patient temperature feedback required
for automatic patient temperature control.
A second patient temperature probe and cable are
recommended to be connected into the Temp In 2 Connector.
Temp In 2 is used to provide monitoring from a second patient
Patient
Temp 1
Patient
Temp 2
Fluid
Delivery
Line
Power
Switch
Patient
Temp
Out
Serial
Number
Fill Tube
Parking
Power
Cord
Air
Filter
USB
Port
Ethernet
Port
RS232
Port

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13
site for increased patient safety when patient temperature is
not continuously monitored by a second device.
NOTE: Patient temperature is not controlled from the Temp In
2 connector. It is for patient temperature monitoring only.
SYSTEM COMPONENTS (Continued)
Patient Temperature Output Cables
The Arctic Sun™ Temperature Management System Control
Module has the capability to output the current Temp In 1
reading to a YSI 400 compatible hospital monitor. The Arctic
Sun™ Temperature Management System temperature output
cables are available with several connector styles (e.g. Phillips,
GE, Rusch, Bard, Nellcor) for compatibility with the various
hospital monitor input cables. Select the patient temperature
cable with the correct connector style for your hospital monitor.
NOTE: The temperatures displayed on the Arctic Sun™
Temperature Management System Control Panel and the
hospital monitor represents the same probe reading but may
not be identical due to calibration differences between the
Control Module and the monitor.
Figure IV-3. Temperature output cables

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

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15
VI. OPERATION GUIDE
THERAPY PREPARATION
Place ArcticGel™ Pads
Read the Instructions for Use that accompanies the
ArcticGel™ pads. Examine each pad for damage prior to
placement.
Connect ArcticGel™ Pads
Water flows between the ArcticGel™ pads and Control Module
via a Fluid Delivery Line. Each side of the Fluid Delivery Line
can be placed by the feet or along the lower legs. There are
three connectors on each side of the line for a total of six
connectors. These will accommodate a full kit of four pads plus
a maximum of two optional Universal pads for use in larger
patients.
To connect the ArcticGel™ Pads:
1) 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.
2) If the connectors are not aligned properly, the connectors
will not fit or click into place.
Patient Placement
The Arctic Sun™ Temperature Management System operates
under negative pressure, which helps the pads to conform to
the patient’s body and minimizes the risk of leaks in the event
of accidental puncture of a pad or accidental disconnection of
the Fluid Delivery Line. In order to ensure negative pressure on
the pads at all times, the patient’s bed surface should be
placed 30 inches to 60 inches (75 cm to 150 cm) above the
floor.
Device Placement
It is recommended to position the device near the foot of the
bed during use. Use the wheel locks on the Control Module to
prevent the wheels from rotating during use. Press down on
the wheel locks to lock the wheels, and lift up the wheel locks
to release the wheels.
Temperature Probe Placement
Refer to the manufacturer’s Instructions for Use for the specific
indications and temperature probe placement. Select the
patient temperature cable with the correct connector style for
your chosen temperature probe to measure core temperature.
Insert the cable into the Temp In 1 connector port on the back
of the device for monitoring patient temperature on the Arctic
Sun™ Temperature Management System.
THERAPY SELECTION
Use the Therapy Selection screen to initiate a New Patient,
Continue a Current Patient, or access the Advanced Setup
screen.
New Patient–Normothermia
If the therapy goal is to maintain a patient temperature at a pre-
defined target temperature for an indefinite period of time,
press the button next to Normothermia to display the
Normothermia therapy screen.
Pressing the Normothermia button will initiate a New Patient
therapy and will reset the Normothermia therapy screen to the
saved system default settings. Any active, current patient
therapy settings and patient data will no longer be available.
New Patient–Hypothermia
If the therapy goal is to reduce and maintain a patient
temperature at a set target temperature for a defined period of
time then slowly rewarm the patient at a controlled rewarming
rate, press the button next to Hypothermia to display the
Hypothermia therapy screen.
Pressing the Hypothermia button will initiate a new patient
therapy and will reset the Hypothermia therapy screen to the
saved system default settings. Any active, current patient
therapy settings and data will no longer be available.
Additional Protocol Option
Two additional protocols (Hypothermia or Normothermia)
may be visible on the Therapy Selection screen. See VI.
Operation Guide–Advanced Setup–Save Settings as
Default for instructions on how to add custom protocols on the
Therapy Selection screen.
Confirm New Patient
The therapy selected will override the active, current patient
therapy. To continue a current case, press Continue. To begin
a new therapy, press New.
Current Patient
The Continue Current Patient button and the date and time
that the current therapy was paused will display on the
Therapy Selection screen if a patient therapy was paused
within the past 6 hours.
Press the Continue button to resume a paused patient
therapy. Selecting the Continue button will display the
appropriate therapy screen. The therapy screen will retain and
display the previously set therapy settings and patient data.
NOTE: Continuation of a current patient therapy will be
available whether the Control Module was Powered On or Off
in the preceding 6 hours.
PATIENT PAD SELECTION
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.
Figure VI-1. Pad selection screen

Operator’s Manual
16
THERAPY SCREENS
The following information is displayed and functions are
available from the Normothermia and Hypothermia therapy
screen.
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
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. WiFi Connected (if enabled)
16. Rewarming (Hypothermia Screen)
Figure VI-2. Hypothermia therapy screen when using
adult ArcticGel™ pads

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17
THERAPY SCREENS (Continued)
The following information is displayed and functions are
available from the Normothermia and Hypothermia therapy
screen.
1. Therapy Selection (or Screen Lock)
2. System Access
3. Notification
4. Temperature Units (if enabled)
5. Patient Status
C. Patient Temperature
D. Patient Temperature 2 (if enabled)
6. System Status
E. Water Temperature
F. Flow Rate
7. Therapy Graph
I. Patient Temperature
J. Water Temperature
K. Date and Time
L. 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. WiFi Disconnected (if enabled)
Figure VI-3. Normothermia therapy screen when using adult
ArcticGel™ pads

Operator’s Manual
18
THERAPY SCREENS (Continued)
1. Therapy Selection
If the therapy has not started or is not currently running,
pressing the therapy selection button ( ) will return the
user to the Therapy Selection screen.
Screen Lock
When an active therapy is running, the therapy selection
button will change to the screen lock button ( ). Press
the screen lock button to manually display the therapy
status screen. By default, after approximately 2 minutes of
inactivity, the screen will lock to prevent inadvertently
changing parameters during patient therapy.
The therapy status screen will appear over the therapy
screen when the screen is locked. The status screen
displays the Patient Temperature, Water Temperature,
Arctic Sun Work to Cool, and the current therapy phase
target temperature. Press the button on the top right of the
status screen to return to the therapy screen.
See section VIII. Troubleshooting–Screen–Screen
Locked if there is a problem with screen lock.
Figure VI-4. Status Screen
2. System Access
The System Access screen allows the user to view
diagnostic information and a log of events during the last
10 cases.
Diagnostics
Selecting the Diagnostics button on the System Access
screen allows the user to view the flow, pressure, patient
temperature and individual water temperature sensor
readings. This information is valuable during the
troubleshooting process.
Event Log
Selecting the Event Log button on the System Access
Screen will display a record of non-recoverable system
alarms and recoverable alarms from the last 10 cases.
After 10 cases, the event log will overwrite the data in a
first in, first out format when new cases are initiated.
The Event Log is still maintained when the system is
powered down or if the system experiences a complete
loss of power. Time of power down is not captured in the
Event Log.
3. Notification
Notifications are active when attention to the system is
required (e.g. preventative maintenance).
When a notification is active, a small icon ( ) will appear
next to the System Access button. Press the System
Access button to read the notification.
4. Temperature Units (if enabled)
From the Normothermia therapy screen or the
Hypothermia therapy screen, press the °C/°F button to
toggle the displayed patient and water temperatures
between °C and °F.
NOTES: The °C/°F button is not visible when the
Temperature Units Adjust parameter in Normothermia
Settings or Hypothermia Settings is disabled. Set the
Temperature Units Adjust parameter to enabled in order
for the °C/°F button to display.
See section VI. Operation Guide–Therapy Settings–
Temperature Units Adjust for further instructions on
enabling/disabling this feature.
5. Patient Status
The following Patient status information is displayed in the
upper left side of the therapy screen.
A. Patient Temperature
• Displays the temperature input from the Temp In 1
connector.
• Temp In 1 is the patient temperature input utilized by
the device for automatic patient temperature control.
Range:
10°C to 44°C
50°F to 111.2°F
Increments:
0.1°C/°F
• If a patient temperature probe is not connected into
the Temp In 1 connector, or the temperature is out
of the display range, then the patient temperature
will display dashes (--.-).
• If a patient temperature probe is not connected into
the Temp In 1 connector when you attempt to Start
therapy, an alarm will occur.
B. Patient Temperature 2 (if enabled)
• Displays the temperature input to the Temp In 2
connector.
• Temp In 2 is for additional patient temperature
monitoring only. It is not utilized by the device for
automatic patient temperature control.
Range:
10°C to 44°C
50°F to 111.2°F
Increments:
0.1°C/°F
• If a patient temperature probe is not connected into
the Temp In connector, or the temperature is out of
the display range, then the patient temperature will
display dashes (--.-).

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19
THERAPY SCREENS (Continued)
• Patient Temperature 2 must be enabled in the
Normothermia Settings or Hypothermia Settings
for Patient Temperature 2 to display.
NOTE: See section VI. Operation Guide–Therapy
Settings–Patient Temperature 2 for instructions on
enabling/disabling Patient Temperature 2.
6. System Status
The following System status information is displayed in
the upper right side of the therapy screen.
C. Water Temperature
• Displays the temperature of the circulating water.
• If the current water temperature is at the pre-set
“high water temperature” or “low water temperature”
limit, then the word “Limit” will appear on the screen,
next to the displayed water temperature.
D. Flow Rate
Displays the water flow rate in liters per minute.
7. Therapy Graph
The temperature graph displays the patient temperature
history, patient target temperature, water temperature
history, and Monitor Mode thresholds (if enabled) over
time on the therapy screen.
E. Patient Temperature
• The patient temperature scale displays in yellow on
the left side of the graph.
• The patient temperature is represented on the graph
by a solid thick yellow line. (If Patient Temperature
2 is enabled it is represented by a thin yellow line.)
• The patient target temperature is represented on the
graph by a dotted yellow line.
F. Water Temperature
• The water temperature scale displays in blue on the
right side of the graph.
• The water temperature is represented on the graph
by a solid blue line.
G. Date and Time
• The temperature graph is divided into 5 segments
denoted by time markers 00:00, 04:00, 08:00, 12:00,
16:00, and 20:00.
• During Hypothermia therapy, the graph background
is color coded to represent the current time
remaining in both the Cool and Rewarm therapies.
• A vertical time line displays to signify the current
system time.
• Use the arrows on either side of the graph to scroll
the graph backward or forward in time. Each press of
the scroll arrow will advance the screen 15 minutes.
H. Progress Bar
• A progress bar displays on the bottom of the
temperature graph to signify the operating modes
active throughout the therapy.
• A green line denotes Control Patient, Cooling or
Rewarming.
• A blue line denotes Manual Control.
• A red line denotes Stop mode.
• No line represents time when system was Powered
Off or when the current case was not active.
8. Empty Pads
The Empty Pads feature empties water from the
ArcticGel™ pads and fluid delivery lines into the Control
Module reservoir.
To Empty Pads:
1) From the Normothermia therapy screen or the
Hypothermia therapy screen, press the Empty Pads
button.
2) The Empty Pads window will appear. Follow the
directions on the screen.
3) Press the Empty button to begin to automatically
empty the pads.
4) The Emptying Pads screen will appear and animate
during the emptying process.
5) The emptying process will automatically stop when the
pads are empty.
6) To stop the process early, press the Stop button.
7) Press the Cancel button to close the screen.
NOTE: The Empty Pads button is not visible and the
feature disabled when the Control, Cooling, Rewarming
or Manual Control functions are active. The system must
be in Stop mode for the Empty Pads button to be visible
and functional.
9. Fill Reservoir
See section V. Setup Procedure–Fill Reservoir.

Operator’s Manual
20
THERAPY SCREENS (Continued)
10. Monitor Mode
The Monitor Mode feature delivers active therapy when
user-defined thresholds are crossed. This feature is useful
for temperature surveillance of the patient.
The Monitor Mode button appears on the therapy screen
when Monitor Mode is enabled as Automatic or Manual in
the therapy settings.
Press the Monitor Mode button to display the Monitor
Mode–Adjust window. Use the Up and Down arrows to
adjust the Upper limit, Lower limit, and Duration limits.
Figure VI-5. Monitor Mode Adjust Screen
When activated, the Monitor Mode temperature limits will
be displayed as dotted lines above and below the target
temperature on the therapy screen. When active, the flow
rate status will indicate “Monitoring” and the “Monitoring”
message will be animated on the status screen. To stop
Monitor Mode, press Stop on the main therapy screen.
See VI. Operation Guide–Therapy Settings–Monitor
Mode to activate Monitor Mode and change the Monitor
Mode setting to Automatic, Disabled, or Manual.
In Monitor Mode set to Automatic, the system will resume
control of patient temperature to the configured target
temperature when the patient temperature has been
outside of the user-defined limits for greater than the user-
defined duration limit. Return to patient temperature will
occur as quickly as possible without ramp.
In Monitor Mode set to Manual, an alert will appear on the
screen after the patient temperature has been outside of
the user-defined limits for greater than the user-defined
duration limit. The alert will recur every 15 minutes if the
temperature remains outside the limit bands. The user
must then manually start therapy if desired from the
Normothermia or Hypothermia therapy screen.
Upper limit
Control Strategy
1,2
3
Range:
33.5°C to 38.5°C
92.3°F to 101.3°F
32.5°C to 38.5°C
90.5°F to 101.3°F
Increments:
0.1°C/°F
0.1°C/°F
Lower limit
Control Strategy
1,2
3
Range:
33.0°C to 38.0°C
91.4°F to 100.4°F
32.0°C to 38.0°C
89.6°F to 100.4°F
Increments:
0.1°C/°F
0.1°C/°F
Duration Limit
Range:
0 to 1 hr.
Increments:
0, 5, 10, 15, 30, 45, 60 min
NOTE: Monitor Mode is inaccessible during active cooling.
When Monitor Mode is active, Arctic Sun Work to Cool will
not be displayed, water temperature will be dashed, and
flow rate will be zero in the therapy graph and status
screen.
NOTE: Monitor Mode only applies to the normothermia
phase or the rewarming phase when the rate is set to
Maximum. To start Monitor Mode, the difference between
the patient temperature and target temperature must be
within 0.5°C (0.9°F) and the patient temperature must be
within the selected upper/lower limits.
11. Arctic Sun Work to Cool
The Arctic Sun Work to Cool feature will monitor the heat
removed by the Arctic Sun Temperature Management
System during active Normothermia or Hypothermia
therapy when using Adult ArcticGel™ Pads.
This feature measures changes in water temperature
between the pads and the system in order to calculate
average heat transfer to the Arctic Sun temperature
management system. Arctic Sun Work to Cool levels are
displayed on the Arctic Sun Work to Cool graph under the
therapy graph and on an Arctic Sun Work to Cool gauge
displayed on the status screen.
The Arctic Sun Work to Cool graph will begin to display
once patient therapy has been started. Each bar
represents the average heat removed during Hypothermia
or Normothermia over the last 15 minutes.
Arctic Sun Work to Cool is displayed in either blue or
orange corresponding to changes in heat transfer to the
Arctic Sun Temperature Management System during
therapy. The threshold for the change in color from blue
to orange can be adjusted in Therapy Settings, but will be
set at a default of 250 W.