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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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