THERMA 003-99 - Safety Instructions

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READ THIS FIRST * SAVE THESE INSTRUCTIONS * IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS CAREFULLY BEFORE USING THE THERMAL THERAPY UNIT
Avoid these potentially hazardous situations which, if not avoided, may result in death or serious injury:
• ThermaZone therapy units are classied by the FDA as class II medical devices that must be prescribed
by a Physician or Licensed Healthcare Professional. [Instruction Manual.
• 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 pad while the unit is being operated. Doing so may create excessive pressure
between the pad 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 e󰀨ect.
• DO NOT apply pads so tightly as to restrict blood or uid ow. Dressings used under pads should be
applied lightly.
• 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 qualied
technician.
• DO NOT leave unsupervised when the unit is being used near children or inrm 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 ame, ammable 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 re,
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 specied 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 pad 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 di󰀨erences 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 e󰀨ects to the skin, shut o󰀨 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 lling or emptying water. Turn o󰀨 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
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