Medivance BD Arctic Sun 6000, Operator'S Manual

Page: 9 / 57

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.