arctic_sun_2000_operators_manual_rev_p.pdf
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Arctic Sun® 2000
O p e r a t o r ’s M a n u a l
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contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Customer Information and Technical Support . . . . . . . . . . . . . . . . v
Section One
1.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.2 Symbols and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.3 Environmental Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.4 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
1.5 Contraindications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.6 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
1.7 Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Section Two
2.1 System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.2 Model 2000 Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3 Remote Display and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . 20
2.4 Fluid Delivery Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.5 Patient Temperature Cables and Probes . . . . . . . . . . . . . . . . 24
2.6 Temperature Out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.7 ArcticGel Pads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Section Three
3.1 Initial Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.2 Filling the Control Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.3 Location of the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
3.4 Draining the Control Module . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.5 Cleaning and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
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Arctic Sun 2000 Operator’s Manual
3.6 Service and Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
3.7 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Section Four
4.1 Beginning a Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.2 Setting Custom Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.3 Collecting Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.4 Pre-warming or Pre-cooling the Model 2000 . . . . . . . . . . . . . 41
4.5 Placing the ArcticGel Pads . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
4.6 Connecting the Pads to the Fluid Delivery Lines . . . . . . . . . . 47
4.7 Pad Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
4.8 Treating a Patient Using Automatic Mode . . . . . . . . . . . . . . . 49
4.9 Treating a Patient Using Manual Mode . . . . . . . . . . . . . . . . . 53
4.10 Water Flow Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
4.11 Interrupting Treatment for Patient Transport . . . . . . . . . . . . 56
4.12 Ending a Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Section Five
5.1 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.2 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.2 Troubleshooting the Arctic Sun System . . . . . . . . . . . . . . . . . 60
Appendices
A. Installation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
B. Alarms/Alerts Description & Specifications . . . . . . . . . . . . . . 68
C. Alarm/Alerts List and Actions to Correct . . . . . . . . . . . . . . . . . 70
D. Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
E. Data Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
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preface
This Operator’s Manual provides a detailed discussion of the Arctic Sun Temperature Management System
from Medivance, Inc., its components, and relevant accessories. The Arctic Sun System provides a safe and
effective way of modifying patient temperature, providing precise temperature control in a novel approach.
The Arctic Sun Model 2000 is equipped with numerous safety and control features, such as temperature and
system alarms and alerts, and programmability. It is important for the operator to become familiar with the
operation of the system prior to use. Reading and understanding this Operator’s Manual will guide the user in
the safe and effective use of the system.
This manual is associated with software version 4.xx. The version of software installed in each Model 2000 is
displayed on the Remote Display’s custom menu display at power up. Features may differ with other versions.
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Customer Information Technical Support
Medivance hours of operation are 8 am to 5 pm Mountain Standard Time. Emergency support is
offered after hours by calling 303-926-1917 or 877-267-2314. Additional educational materials, such
as training programs for in-house staff, operator manuals, quick reference guides, and a bibliography
of relevant materials are available to all Medivance Customers. Prior to using the Arctic Sun, a
Medivance representative will provide on-site in-services to ensure adequate training has occurred.
Additional requests for technical support, information or orders may be placed by mail, fax, or by
calling Medivance Customer Service:
Model No.
Arctic Sun Model 2000
Phone:
Toll free (877) 267-2314
Fax:
(720) 880-5400
Address:
321 South Taylor Ave., Suite 200
Louisville, CO 80027
E-mail:
customerservice@medivance.com
Internet:
www.medivance.com
European Representative:
Medivance EU BV
0050
President Kennedylaan 19
2517 JK ‘S-Gravenhage
The Netherlands
EC
REP
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1
section
1.1 Introduction
The effect of temperature variations on the human body has been well documented. Elevated
temperatures may be harmful to the brain under normal conditions, and even more importantly,
during periods of physical stress, such as illness or surgery. Conversely, lower body temperatures,
or mild hypothermia, may offer some degree of neuroprotection.1 Moderate to profound hypothermia
(below 32ºC) tends to be more harmful to the body and may lead to death.2
Temperature management or thermoregulation can be viewed in two different ways. The first aspect
of temperature management includes treating abnormal body temperatures, i.e. cooling the body
Schwab S, Schwartz S, Spranger M, et al.
Moderate Hypothermia in the Treatment of
Patients with Severe Middle Cerebral Artery
Infarction. Stroke 1998; 29 (12): 2461-6
1
Guyton A, Hall J. Textbook of Medical
Physiology, Ninth Ed (Philadelphia, PA: W.B.
Saunders, 1996): 119
from elevated temperatures (hyperthermia), or warming the body to manage hypothermia. The
second aspect of thermoregulation is an evolving treatment that employs techniques that physically
control a patient’s temperature to provide a physiological benefit, such as cooling for a degree of
neuroprotection3,4.
2
Ginsberg M, Sternau L, et al. Therapeutic
Modulation of Brain Temperature: Relevance to
Ischemic Brain Injury. Cerebrovascular Brain
Metabolism Review 1992; 4 (3): 189- 225
3
4
Corbett D,; Thornhill J. Temperature Modulation
(Hypothermic and Hyperthermic Conditions)
and its Influence on Histological and Behavioral
Outcomes Following Cerebral Ischemia. Brain
Pathology 2000; 10(1): 145-52.
5
Sessler DI. Perioperative Heat Balance.
Anesthesiology 2000; 92: 578-96
6
Hypothermia may occur for a variety of reasons, including exposure to cold environments, trauma,
or long complex surgical procedures. Hyperthermia may occur as a result of systemic inflammatory
response, sepsis, stroke, or other brain injury. While the mechanism of the effect of the hyperthermia
on the brain is not clearly understood, there is evidence to indicate that even mild increases in
temperature may contribute to neurological deficits.5
The Medivance Arctic Sun Temperature Management System has been designed to regulate
body temperature for those patients who require procedures requiring therapeutic temperature
management and/or to assist in controlling temperature for specific medical or surgical conditions.
!
CAUTION: This product is to be used by or under the supervision of trained, qualified medical
personnel.
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Arctic Sun 2000 Operator’s Manual
1.2 Symbols and Standards
The Arctic Sun Model 2000 bears the following symbols:
For the safe and effective use of this device, the operator must consult the accompanying documents
prior to use.
EC REP
Identifies European Representative.
This symbol adjacent to the patient connections means that the thermal probe connection is a
“Defibrillator-Proof, Type BF Applied Part”, per standard IEC 60601-1 and affords the degree of patient
protection defined in that standard for this type of applied part.
Models of the Arctic Sun that bear the Entela US/C Monogram have been Certified for Safety by Entela,
Inc. against standards C22.2, No. 601.1 and UL 2601.
Identifies the equipotential terminal on the equipment, which is intended to be connected with the
equipotential terminal(s) on one or more other types of equipment in close proximity, in order to bring all
pieces of equipment to the same potential for safety purposes.
Indicates high temperature part or component.
Indicates that only sterile or distilled water should be used when filling the Arctic Sun Control Module.
Identifies Patient Temperature 1, the patient temperature probe input for monitoring and control.
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Identifies Patient Temperature 2, the patient temperature probe input for monitoring.
Identifies the drain port.
Identifies the storage temperature range.
Identifies the storage relative humidity range.
Indicates electrical hazard
Indicates Earth Ground
Identifies the heater fuse.
The Arctic Sun Control Module meets both the electromagnetic interference and
susceptibility requirements of IEC 601-1, and is compatible with other equipment that
also conforms to that standard. There is no known failure mode in the Arctic Sun
Control Module associated with electromagnetic interference from other devices.
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1.3 Environmental Conditions
The Arctic Sun Model 2000 should be stored and used in specific operating conditions: Operating
Temperature Range: 10ºC to 27ºC (50ºF to 80ºF)
Storage Temperature Range: -30ºC to 50ºC (-20ºF to 120ºF)
At operating temperatures higher than 27ºC (80ºF), 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, refer to the Service Manual for special draining procedures.
Ambient Humidity Range:
Operating: 5% to 70% relative humidity, non-condensing
Storage: 5% to 95% relative humidity, non-condensing
1.4 Indications for Use
The Arctic Sun Temperature Management System is intended for monitoring and controlling patient
temperature within a range of 32°C to 38.5°C (89.6ºF to 101.3ºF).
The indications for use include any condition where patient temperature control within a range
covering mild hypothermia to normothermia is required. This would include, but not limited to, medical,
surgical, febrile, accidental hypothermia, or heat stroke patients.
!
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
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1.5 Contraindications for Use
There are no known contraindications for the use of a thermoregulatory system.
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.
1.6 Warnings
!
• Do not use the Arctic Sun in the presence of flammable agents because an explosion and/or
fire may result.
• 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, note that all other thermal conductive systems, such as water blankets and
water gels, in use while warming or cooling with the Arctic Sun may actually alter or interfere with patient
temperature control.
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1.7 Cautions
!
• This product is to be used by or under the supervision of trained, qualified medical personnel.
• Federal law (USA) restricts this device to sale, by or on the order of a physician.
• Use only distilled or sterile water. The use of other fluids will damage the Arctic Sun Model 2000.
• 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 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.
• The operator must continuously monitor patient temperature in Manual Mode. Patient temperature will not
be controlled by the Arctic Sun in Manual Mode.
• The Arctic Sun will monitor and control patient core temperature based on the temperature probe attached
to the system. Medivance recommends measuring patient temperature from a second site to verify patient
temperature.
• It is the sole responsibility of the clinician or operator to monitor patient temperature during Manual Mode
and to adjust the temperature of the water flowing through the pads accordingly.
• Due to the system’s high efficiency, Manual Mode is not recommended for non-surgical treatments that
require cooling.
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• Patient temperature will not be controlled and alarms are not enabled in Stop Mode. Patient temperature
may increase or decrease with the Arctic Sun in Stop Mode.
• It is advisable not to cancel the alarm or alert until the situation is resolved. If an alarm is cancelled and
the condition has not been corrected, the alarm will recur. If an alert is cancelled and the alert condition
has not been corrected, the alert will not recur unless the Stop Mode is activated.
• Carefully observe the system for air leaks in the system 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 Model 2000 is for use only with the ArcticGel Pads.
• The ArcticGel Pads are only for use with an Arctic Sun Model 2000.
• 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.
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• Use pads immediately after opening. Do not store pads once the kit has been opened.
• Do not allow circulating water to contaminate the sterile field when patient lines are disconnected.
• The water content of the hydrogel affects the pad’s adhesion to the skin and conductivity, and therefore,
the efficiency of controlling patient temperature. Periodically check that pads remain moist and adherent.
Replace pads when the hydrogel no longer uniformly adheres to the skin. Replacing pads at least every 5
days is recommended.
• Do not puncture the ArcticGel Pads with sharp objects. Punctures will result in air entering the fluid
pathway and may reduce performance.
• If accessible, examine the patient’s skin under the ArcticGel Pads often, especially those at higher risk of
skin injury.
• Skin injury may occur as a cumulative result of pressure, time and temperature. Do not place bean bag or
other firm positioning devices under the ArcticGel Pads. Do not place positioning devices under the pad
manifolds or patient lines.
• The rate of temperature change and potentially the final achievable patient temperature is affected
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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 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, environmental factors such
as excessively hot rooms, heat lamps, and heated nebulizers are eliminated, water flow is greater than or
equal to 2.3 liters per minute, a patient temperature probe is in the correct place, and patient shivering is
controlled. Otherwise, consider increasing minimum water temperature, modifying target temperature to
an attainable setting, or discontinuing treatment.
• Due to underlying medical or physiological conditions, some patients are more susceptible to skin damage
from pressure and heat or cold. Patients at risk include those with poor tissue perfusion or poor skin
integrity due to diabetes, peripheral vascular disease, poor nutritional status, steroid use or high dose
vasopressor therapy. If warranted, use pressure relieving or pressure reducing devices under the patient to
protect from of skin injury.
• Do not allow antibacterial agents to pool underneath the ArcticGel Pads. Excess antibacterial agents can
absorb into the pad adhesive and cause chemical burns and loss of pad adhesion.
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• Do not place ArcticGel Pads over an electrosurgical grounding pad. The combination of
heat sources may result in skin burns.
• Carefully remove ArcticGel Pads from the patient’s skin at the completion of use.
• Any device connected to the RS232 data port must comply with the applicable IEC standard
for that device.
• 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.
• Medivance will not be responsible for patient safety or equipment performance if the procedures
to operate, maintain, modify or service the Medivance Arctic Sun are other than those specified by
Medivance. Anyone performing the procedures must be appropriately trained and qualified.
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2
section
2.1 System Description
The Arctic Sun Temperature Management System is a thermoregulatory device that
monitors and controls patient temperature within a range of 32°C to 38.5°C (89.6°F to
101.3°F). The Arctic Sun System consists of the Model 2000 and disposable ArcticGel Pads.
The Model 2000 consists of the Control Module, Remote Display, Fluid Delivery Line, cables
and accessories.
The Model 2000 pulls temperature-controlled water ranging between 4°C and 42°C (39.2°F
and 107.6°F) through the ArcticGel Pads at approximately 0.7 liter per minute per pad. This
results in heat exchange between the water and the patient. Unlike conventional water
based systems, this system operates under negative pressure relative to ambient. Any
break or leak in the system will result in air entering the circuit instead of water leaking out.
Figure 1
The Remote Display can be stored
in its parking spot on the Control
Module when not in use.
Figure 2 (right)
When in use, the display is
attached to the upright handle
for easy visibility.
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The system functions in either an Automatic Mode or Manual Mode. In Automatic Mode,
a patient temperature probe, connected to the Control Module, provides feedback to
an internal control algorithm. The temperature of the water increases or decreases
automatically to achieve a pre-set patient target temperature determined by the clinician.
In Manual Mode, the feedback control algorithm is not activated. The operator adjusts the
temperature of the water delivered to the pads directly and is responsible for monitoring
patient temperature.
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The Arctic Sun Control Module must be used only with the ArcticGel Pads. The pads are
thin, and anatomically shaped to cover areas of the patient’s skin. They come in non-sterile
kits in sizes to cover a broad range of patients, fit both males and females, and are for single
patient use only. Each pad has an inlet and an outlet connection that attaches to a Fluid
Delivery Line. Up to six pads can be connected at one time. The pads are designed so
that water flows within internal pathways across its surface to provide even, efficient heat
transfer between the skin and water. The pads adhere to the patient’s skin by the use of a
biocompatible compatible hydrogel adhesive. The hydrogel maintains its adhesion level over
extended periods. The pads can be repositioned on the patient’s skin if needed. The back of
each pad is insulated to minimize heat transfer to the environment and condensation when
cooling.
The Arctic Sun Model 2000 is a CLASS I (Type BF, IPX0 and Mode of Operation - Continuous)
portable device per classification scheme of IEC 601-1.
!
CAUTION: The Arctic Sun Model 2000 is for use only with the ArcticGel Pads.
The Arctic Sun Control Module can be placed in various locations in the intensive care unit
or operating room while being controlled from the Remote Display. The Control Module has
a four wheel independent locks. Its handle can be raised and locked for transport or placed
in the down position for storage. (See figure 1 and 2) Do not lift the Control Module by the
handle.
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2.2 Model 2000 Components
The Fluid Delivery Lines, Patient Temperature Cables, Temperature Out Cable, Remote Display Cable,
and the Power Cord are connected to the rear of the Arctic Sun Control Module (See Figure 3), find
lengths of tubes and cables in Table 1.
Table 1
Accessory
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Length
Remote Display Cable
42 inches 1.1 meters
Power Cord
15 feet
4.6 meters
Fluid Delivery Line
10 feet
3.0 meters
Patient Temperature Cable
10 feet
3.0 meters
Temperature Out Cable
5 inches
13 centimeters
Fill/Drain Tube
24’’
0.6 meters
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Arctic Sun 2000 Operator’s Manual
Remote Display
Fluid Delivery Line Storage
Latch Handle
Remote Display Connector
Fill Port
Power Switch
Fluid Delivery Line & Connection
Power Cord Connection
Data Collection Connector – RS232
Equipotential Grounding Stud
Reserved for Future Use
Heater Fuse
Fill/Drain Tube
Strain Relief Mount
Patient Temperature 1 Connector
Power Cord Storage
Patient Temperature 2 Connector
Temperature Out Connector
Drain Ports
Figure 3
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2.3 Remote Display and Controls
The Arctic Sun Model 2000 is operated from the Remote Display (Figure 4). The display is
clamped to the Control Module handle. The Remote Display is connected to the Control
Module by a 42 inch (1.1 meter) Remote Display Cable.
Modes of Operation
There are four principle modes of operation. These can be accessed by pressing any of
the four keys on the lower right side of the display: Automatic, Manual, Purge, and Stop.
Each key represents a unique function:
Automatic Mode The Automatic Mode only operates when an appropriate patient
temperature probe is placed and connected
to the Control Module. The Arctic Sun will
adjust the temperature of the water flowing
through the ArcticGel Pads to achieve a preset patient target temperature. The maximum
and minimum water temperatures allowed during this mode
can also be set by the user. Patient target temperature and
water temperature limit settings can only be changed by
returning to Stop Mode and accessing the custom menu
with the down or up arrows. Note: If a patient temperature
probe is not attached to the Patient Temperature 1
Connector, the display will alarm and return to Stop Mode.
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Figure 4
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Arctic Sun 2000 Operator’s Manual
Manual Mode The Manual Mode operates with or without a patient temperature probe placed
and connected to the Control Module. Water temperature is set and managed directly by the
operator. Patient temperature is not controlled in Manual Mode. The operator must monitor
patient temperature when Manual Mode is active. Water temperature can be modified during
the Manual Mode Operation.
Note: Manual Mode may be enabled/disabled in Advanced Settings. An alarm will be generated if the Manual
Key is pressed when Manual Mode is disabled. When Manual Mode is disabled, the water target display is
not accessible. To disable Manual Mode and make as the default setting, see instructions in Chapter 4.
!
!
CAUTION: Manual mode is not recommended for non-surgical treatments that require cooling.
CAUTION: The operator must monitor patient temperature in Manual Mode. Patient temperature will
not be automatically controlled in Manual Mode.
Purge Mode The Purge Mode removes water from the ArcticGel Pads prior to disconnection.
Water flows from the pads back to the reservoir, which minimizes leaks and reduces the
amount of water remaining in the pads. Purge will automatically stop after 30 seconds.
Note: Pads should be purged prior to a Fill Cycle. Failure to purge pads before filling may be
result in overfilling the Control Module.
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Stop Mode The Stop Mode halts all other modes of operation. During power up and alarm
states, the system defaults to Stop Mode. The Stop Mode offers a secondary function, serving
as the access point for the custom menu settings.
!
CAUTION: Patient temperature will not be controlled in the Stop Mode. Patient
temperature may increase or decrease with the Arctic Sun in Stop Mode. Alarms are not enabled in the Stop
Mode.
Custom Menu Display and Keys The Remote Display offers a variety of custom menu options that are
displayed on the custom menu display. Alarms, alerts and system status are also displayed.
The custom menu display can be modified by using the menu control keys.
Figure 5
Down and Up Arrow Keys In Stop Mode, allows the operator to review custom menu
options screens. The arrows are also used for adjusting custom option parameters.
During Manual Mode, these arrows provide access to modify the Water Target
Temperature.
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Arctic Sun 2000 Operator’s Manual
Enter Key Press the Enter key when accepting modifications or changes to a custom parameter.
Home Key Press the Home key to return to the current operating mode’s main screen when in any
custom display screen. Pressing this key does not accept modifications or changes to custom
parameter. The display will automatically return to the current operating mode’s main screen if
there are no keys pressed within 60 seconds.
Alarm Key The Alarm Key is illuminated when situations arise that may pose a safety issue for
the patient or if the system detects it may not be performing properly. Press the Alarm key to
acknowledge and silence an alarm or alert
Patient Temperature Trend Indicator The Patient Temperature Trend Indicator reflects the
rate of change in the patient’s temperature over the previous five minutes. Yellow arrows will
flash at different times with differing rates of change. Up arrows indicate patient temperature
is increasing. Down arrows indicate patient temperature is decreasing.
Center circle no change or less than 0.25°C (0.45°F) change per hour
One arrow (up or down) - 0.25°C to 0.5°C (0.45°F to 0.96°F) change per hour
Two arrows (up or down) - 0.5°C to 0.75°C (0.96°F to 1.35°F) change per hour
Three arrows (up or down) - 0.75°C to 2.0°C (1.35°F to 3.6°F) change per hour
Three arrows flashing simultaneously - > 2.0°C (> 3.6°F) change per hour
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Patient Temperature Display The Patient Temperature Display indicates
patient temperature from a probe installed in the Patient Temperature 1
Connector. The temperature can be displayed in either degrees Centigrade
(C) or degrees Fahrenheit (F). The display type can be modified in the custom parameter menu found under
the Stop Key under Advanced Settings. The temperature range that can be displayed is between 10° C and
44°C (50°F to 111.2°F).
2.4 Fluid Delivery Line
Water flows between the ArcticGel Pads and Control Module via a Fluid Delivery Line.
The line is attached to the back of the Control Module. The Fluid Delivery Lines are
reusable but may be replaced if necessary. Swing the latch handle to the left, insert the
Fluid Delivery Line connector then lock it into place by swinging the handle to the right
(Figure 6).
Figure 6
2.5 Patient Temperature Cables and Probes
To operate the Arctic Sun Model 2000 in Automatic Mode, an indwelling temperature probe must be inserted
into the patient and connected to a Patient Temperature Cable. The cable is connected to the back of the
Control Module at the Patient Temperature 1 Connector (see Figure 3).
Similarly, a second patient temperature probe may be connected to a second Patient Temperature Cable and
the cable connected to the back of the Control Module Patient in the Patient
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Arctic Sun 2000 Operator’s Manual
Temperature 2 (see Figure 3). Patient Temperature 2 is used to provide redundant monitoring from a second
patient site for increased patient safety when patient temperature is not continuously monitored by a second
device.
Note: Patient temperature is not controlled from the Patient Temperature 2 Connector. It is for patient
temperature monitoring only.
Yellow Springs Instrument 400 Series (YSI 400) compatible patient temperature probes can be connected
to the Arctic Sun Model 2000. These include nasopharyngeal, esophageal, tympanic, rectal, or bladder
probes. Refer to the manufacturer’s Instructions for Use for the specific indications and placement of these
temperature probes. If there is any question regarding the use of a specific temperature probe, contact
Medivance customer service for additional information.
2.6 Temperature Out
The Arctic Sun Control Module will output the current Patient Temperature 1 reading to a YSI 400 compatible
hospital monitor. A Temperature Out Cable is used to connect between the Temperature Out connector (see
Figure 3) and the monitor cable. The temperatures displayed on the Arctic Sun Remote Display and monitor
represents the same probe reading but may not be identical due to calibration differences between the
Control Module and the monitor. If the difference is greater than 0.3ºC (0.6ºF) have qualified personnel check
the calibration of both devices.
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