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The current Operator's Manual can be found at www.medivance.com/manuals.
Chapter 1 – Getting Started
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 and water
gels, in use while warming or cooling with the Arctic Sun™ Temperature
Management System may actually alter or interfere with patient
temperature control.
•
Do not place ArcticGel™ Pads over transdermal medication patches
as warming can increase drug delivery, resulting in possible harm to
the patient.
•
The Arctic Sun™ Temperature Management System is not intended for use in
the operating room environment.
•
Medivance 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 hyper-thermia.
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 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 alert 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.
•
Medivance recommends measuring patient temperature from a second site to
verify patient temperature. Medivance recommends the use of a second patient
temperature probe connected to the Arctic Sun™ Temperature Management
System Temperature 2 input as it provides continuous monitoring and safety
alarm features. Alternatively, patient temperature may be verified periodically with
independent instrumentation.
•
The displayed temperature graph is for general information purposes only and
is not intended to replace standard medical record documentation for use in
therapy decisions.
•
Patient temperature will not be controlled and alarms are not enabled in Stop
Mode. Patient temperature may increase or decrease with the
Arctic Sun™ Temperature Management System in Stop Mode.
•
Carefully observe the system for air leaks before and during use. If the pads
fail to prime or a significant continuous air leak is observed in the pad return
line, check connections. If needed, replace the leaking pad. Leakage may result
in lower flow rates and potentially decrease the performance of the system.
•
The Arctic Sun™ Temperature Management System is for use only with the
ArcticGel™ Pads.
•
The ArcticGel™ Pads are only for use with the Arctic Sun™ Temperature
Management Systems.
•
The ArcticGel™ Pads are non-sterile for single patient use. Do not reprocess
or sterilize. If used in a sterile environment, pads should be placed according to
the physician's request, either prior to the sterile preparation or sterile draping.
ArcticGel™ Pads should not be placed on a sterile field.
•
Use pads immediately after opening. Do not store pads once the kit has
been opened.
•
Do not place ArcticGel™ Pads on skin that has signs of ulceration, burns,
hives, or rash.
•
While there are no known allergies to hydrogel materials, caution
should be exercised with any patient who has a history of skin allergies
or sensitivities.
•
Do not allow circulating water to contaminate the sterile field when patient
lines are disconnected.
•
The water content of the hydrogel affects the pad's adhesion to the skin and
conductivity, and therefore, the efficiency of controlling patient temperature.
Periodically check that pads remain moist and adherent. Replace pads when
the hydrogel no longer uniformly adheres to the skin. Replacing pads at least
every 5 days is recommended.
•
Do not puncture the ArcticGel™ Pads with sharp objects. Punctures will result
in air entering the fluid pathway and may reduce performance.
•
If accessible, examine the patient's skin under the ArcticGel™ Pads often,
especially those at higher risk of skin injury. Skin injury may occur as a cumulative
result of pressure, time and temperature. 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.
•
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, refer to the
ArcticGel™ pad instructions for use for the appropriate flow rate. For patient
cooling, ensure environmental factors such as excessively hot rooms, heat
lamps, and heated nebulizers are eliminated and patient shivering
is controlled. Otherwise, consider increasing minimum water temperature,
modifying target temperature to an attainable setting or discontinuing
treatment. For patient warming, consider decreasing maximum water
temperature, modifying target temperature to an attainable setting or
discontinuing treatment.
•
Due to underlying medical or physiological conditions, some patients are more
susceptible to skin damage from pressure and heat or cold. Patients at risk
include those with poor tissue perfusion or poor skin integrity due to diabetes,
peripheral vascular disease, poor nutritional status, steroid use or high dose
vasopressor therapy. If warranted, use pressure relieving or pressure reducing
devices under the patient to protect from skin injury.
•
Do not allow urine, antibacterial solutions or other agents to pool underneath
the ArcticGel™ Pads. Urine and antibacterial agents can absorb into the pad
hydrogel and cause chemical injury and loss of pad adhesion. Replace pads
immediately if these fluids come into contact with the hydrogel.
•
Do not place ArcticGel™ Pads over an electrosurgical grounding pad.
The combination of heat sources may result in skin burns.
•
If needed, place defibrillation pads between the ArcticGel™ Pads and the
patient's skin.
•
Carefully remove ArcticGel™ Pads from the patient's skin at the completion of
use. Discard used ArcticGel™ Pads in accordance with hospital procedures for
medical waste.
•
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.
E N G L I S H
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