Avoid these potentially hazardous situations which, if not avoided, may result in death or serious injury:
• ThermaZone therapy units are classified by the FDA as class II medical devices that must be prescribed by a
Physician or Licensed Healthcare Professional.
• DO NOT use the unit for any reason other than its intended use.
• DO NOT use for more than 30 minutes at a time.
• DO NOT use while sleeping.
• DO NOT lie on the brace while the unit is being operating. Doing so may create excessive pressure between the
brace and patient skin that can increase the likelihood of thermal injury.
• DO NOT use this product as a substitute for medical attention.
• ALWAYS follow the protocol provided by the attending physician.
• DO NOT apply ThermaZone Pads to breached or wounded skin.
• ThermaZone pads are intended to be used without any additional ointments, cremes, salves, moisturizers, or similar
topical applications between ThermaZone pads and the body area to be treated. Use of these types of topical
applications may result in undesired tissue effect.
• DO NOT apply pads so tightly as to restrict blood or fluid flow. Dressings used under pads should be applied lightly.
• Pads are NOT sterilized. DO NOT place Single Patient Use Pads in an autoclave or attempt to sterilize.
• DO NOT operate in an operating room.
• DO NOT operate when intended user is connected to life support equipment, cardiac device, and/or
electrophysiology device.
• DO NOT plug into an electrical outlet that is already supporting an appliance.
• DO NOT use unit with an extension cord unless the cord has been checked and tested by a qualified technician.
• DO NOT leave unsupervised when the unit is being used near children or infirm persons.
• DO NOT operate in a wet or moist condition.
• DO NOT use while bathing or in the shower.
• DO NOT leave unattended while in use.
• DO NOT use while smoking or place on or near a hot gas flame, flammable products, electric element or a heated oven.
• DO NOT obstruct vents on the top, front, or back of the unit.
• DO NOT operate if the cord appears damaged or if you have dropped or damaged the unit. Inspect the unit and its
cord beforehand to be sure that it is in good working condition.
• DO NOT use the unit outdoors. The unit is for indoor use only.
• DO NOT operate where aerosol (spray) products are being used.
• DO NOT operate the unit under a blanket, pillow or other such items as excessive heat may cause fire, electrical
shock or other injury.
• DO NOT reach for the unit if it falls into water – unplug it immediately.
• DO NOT drop or insert any object or body part into any opening of the unit.
• DO NOT allow unit, accessories or cord to touch hot surfaces.
• DO NOT run the cord under carpeting or cover it with throw rugs, runners, or the like.
• DO NOT attempt to disassemble or repair your unit as such action may cause a risk of electric shock or injury.
• DO NOT modify equipment.
• DO NOT use with power supplies other than those specified by manufacturer.
• DO NOT consume water removed from the ThermaZone device.
• DO NOT use HEAT mode in ambient temperatures above 85 degrees Fahrenheit (29.4 degrees Celsius).
• Prolonged exposure to heat greater than 46˚ C (115˚ F) may cause skin injury to certain tissues. The user must
exercise caution and monitor discomfort and skin condition accordingly. Remove the brace if pain or discomfort from
the temperature is experienced.
• Decreased sensation from the body’s natural adaptation to heat may cause you to tolerate heat that might cause a
skin burn. Use caution when setting the unit to maximum heat settings and do not use for prolonged periods at these
settings (20 minutes or longer, must be adjusted according to patient tolerance).
• Due to individual differences in sensitivity and susceptibility to cold or heat, the patient’s skin should be frequently
observed. Prolonged exposure to cold or heat has a potential to cause injury to tissue. Follow the instructions of the
attending physician for length, frequency, and duration of treatment. DO NOT use COOL mode in ambient
temperatures below 60 degrees Fahrenheit (16 degrees Celsius).
• To avoid adverse effects to the skin, shut off the ThermaZone unit if patient begins to feel uncomfortable.
• Discontinue use if dizziness, severe pain, or severe skin reaction occurs.
• Be sure to disconnect the unit from electrical outlet when filling or emptying water. Turn off unit before unplugging
from an outlet.
• After operation of the unit, always wait for the unit to return to room temperature before storing.
• As with any product with a cord, there is a risk of strangulation. Take care in storing and using the unit around children.
• Be sure to review the General Precautions in the ThermaZone Instruction and Safety Manual Section 6 before
selecting a Temperature Mode and Comfort Level.
SAFETY INSTRUCTIONS
WARNING
READ THIS FIRST • SAVE THESE INSTRUCTIONS • IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS CAREFULLY BEFORE USING THE THERMAL THERAPY DEVICE
