Medivance ARCTIC SUN Simply Advanced 5000, Руководство оператора

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E N G L I S H
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.
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.
• The operator must continuously monitor patient temperature when using
Manual Control and adjust the temperature of the water flowing through
the pads accordingly. Patient temperature will not be controlled by the
Arctic Sun
®
Temperature Management System in Manual Control.
• Due to the system’s high efficiency, Manual Control is not recommended
for long duration use. The operator is advised to use the automatic therapy
modes (e.g. Control Patient, Cool Patient, Rewarm Patient) 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 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.
• 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, water flow is greater than or equal to 2.3 liters per minute
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.
• 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.