ThermaZone 003-47 User manual

Range of
Motion (ROM)
Knee Brace
with Advanced Heat
or Cool Therapy
• Adjustable, one size ts most
• Fits up to 26", 3" above
the patella.
• Comfortable and lightweight
• Fits right or left knee
• Includes 2 Polycentric hinges to
limit Flexion or Extension.
Made in U.S.A.
This is not a substitute for the ThermaZone Instruction and Safety Manual.
Review the Instruction and Safety Manual prior to using this pad/brace and unit.
MODEL # 003-47
This User’s Manual is also available at www.therma-zone.com in English.
REF
www.therma-zone.com
Individual Pads/Braces
work in conjunction
with the ThermaZone
Thermal Therapy
technology and are
interchangeable
with the unit.

Range of Motion (ROM) Knee Brace
with Advanced Heat or Cool Therapy
1
•Lift the handle.
• Gently peel back black rubber ll cap.
•Slowly pour DISTILLED WATER into the reservoir under
the ll cap (water should drain through hole in the center of
the reservoir).
• Ensure you have lled between “MIN” and “MAX” levels on
the water level indicator to maintain optimal performance.
FILL THE RESERVOIR WITH
DISTILLED WATER
DISTILLED WATER RESERVOIR
HANDLE (RAISED)
CONNECTOR PORTS
AC/DC ADAPTER PLUG
MAX
MI N
INSTALL
A BRACE
2
·Remove the white
caps from the
end of the white
connectors on the
tubing assembly.
• Insert the
connector
on the brace
into the port
on the tubing
assembly until
you feel the
connector click
and lock into
place.
4
! BE SURE WATER LEVEL IS
BETWEEN MIN AND MAX !
MAX
MI N
5CHOOSE THERAPY
SETTINGS
• Select a pre-set timer mode. (optional)
• Choose your desired temperature mode
HEAT or COOL.
• Select comfort level (1-10)
REFILL THE
RESERVOIR
• With unit running, pour additional
DISTILLED WATER ONLY into the
reservoir.
• Monitor water ll level over the
next minute to make sure the
water level settles between the
“MIN” and “MAX” lines.
If this is the rst time you are using the
unit, or the rst time you have installed a
brace, the water from the reservoir will be
pumped into the chambers of the brace
during step 3. At this time, you will need
to re-ll your unit with Distilled Water.
The temperature can be adjusted during therapy by
pushing the (+) or (-) button to increase or decrease
temperature. You can also check the remaining time on
the timer (optional) by pushing
the previously chosen HEAT or
COOL button. The remaining
time will appear in the comfort
level window for 5 seconds and
then the display will return to the
comfort level setting. MODE
HE AT COOL
COMFORT LEVEL
HE AT COOL
COMFORT LEVEL
BEFORE
POWERING ON
3•Plug one end of the power
cord into the electric outlet,
and plug the other end into
the AC/DC adapter plug on
the unit (the control panel will
illuminate).
• Press the ON /OFF button
(the fan and pump will start
and the digital display will
now say “ON”).
THE BRACE MUST BE AT ROOM
TEMPERATURE AND LAYING FLAT. ENSURE
THE BRACE CHAMBER IS UNRESTRICTED,
FOLDED OR BLOCKED. BLOCKAGE COULD
CAUSE THE BRACE TO LEAK OR BREAK
DUE TO THE WATER PRESSURE! MODE
HE AT COOL
COMFORT LEVEL
AC/DC
Adapter
Plug
•Attach the white
connectors to
the connector
ports on the
front of the unit,
by aligning the
tabs and turning
clockwise by 90˚.

Range of Motion (ROM) Knee Brace
with Advanced Heat or Cool Therapy
6
• Wrap the bottom strap across the front of the brace just above
the tubing connectors and secure the hook and loop closure.
• Wrap the top strap behind the leg, just above the
knee cap. Secure the hook and loop closure to
the front of the brace.
• Wrap the center straps behind the knee with the right strap
under the left strap and secure with the hook and loop closure.
Sit back and relax. You are now ready to enjoy the comfort
and convenience of your continuous thermal therapy unit.
If the therapy becomes uncomfortable, remove the brace
immediately and adjust the temperature. Allow the brace
temperature to reset for 10-15 minutes before reapplying.
Braces can be applied directly to intact skin or can be used over
clothing or a thin barrier.
Note: When braces are applied directly to the skin, the temperature
will feel more intense.
DETERMINE DESIRED RANGE
OF MOTION SETTING
• To attach the knee pad align the circle in the center of the brace
with the knee cap.
• The tubing connectors will be at the bottom of the brace.
Note: For
best results
when
switching
from Heat
mode to
Cool mode,
remove
the brace
from your
body for 10
minutes.
MODEL # 003-47
REF
7SET THE RANGE OF MOTION
HINGES
8APPLY YOUR BRACE
9SECURE THE STRAPS
10 BEGIN THERMAL THERAPY
Range of Motion instructions should be
provided by your physician. Refer to the
image to the right to understand the
calculation of the angle for Flexion. 90 60
30
FULL RANGE
15
0
FULL
RANGE
F
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60
90
• Open the hinge cover and remove the pins on the
Flexion side of the hinge.
• Move the hinge arms until the desired Flexion
angle is reached. There will be an opening
through both layers of the hinge in the hole next to
the desired Flexion angle. Drop pins into desired
setting, pushing them rmly into place.
• Set both sides of the hinge (top and bottom) to the
same angle.
• Repeat process for both the left and right hinge.
90 60
30
FULL RANGE
15
0
FULL
RANGE
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FULL RANGE
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FULL
RANGE
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FULL RANGE
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FULL
RANGE
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90 60
30
FULL RANGE
15
0
FULL
RANGE
F
L
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90
Hinge Cover Hinge
Arms
Pins

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.
• 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 uid ow. 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 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 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 lling 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

Avoid these potentially hazardous situations which, if not avoided, may result in minor or moderate
injury, or damage to the ThermaZone Unit or Brace:
• DO NOT position the unit so that it is difcult to operate the disconnection device (plug of the Power supply).
• DO NOT unplug by pulling on the cord.
• DO NOT pull or carry the unit by the cord.
• Unplug from the electrical outlet before cleaning or storing.
• Arrange the blue tubing and cord away from trafc areas and where it will not be tripped over.
• DO NOT drop the unit or brace.
• DO NOT operate or store the unit or brace near pets.
• Before each use, make sure braces are not damaged, punctured or leaking.
• DO NOT puncture the braces.
• To avoid any adverse effects to your health or skin, shut off the unit if you begin to feel discomfort.
• If you are sensitive to hot or cold temperatures, consult your doctor before use.
• Consult the temperature setting warnings and precautions in the instructions when using this unit.
• The application instructions for the ROM Knee Brace are intended for the use of qualied professionals
only. It is not recommended for patients to attempt to apply or adjust this device unless otherwise
instructed to do so by an orthopedic professional. Any questions regarding further adjustment or
frequency / duration of wear should direct to your orthopedic professional who understands the individual
condition for which this device was prescribed.
INTENDED USE
ThermaZone is intended to provide heating or cooling effect at controlled temperatures through
water-circulating, anatomically designed pads for the application of noninvasive localized thermal therapy.
The Range of Motion (ROM) Knee Brace provides stability and support for chronic knee pain and
instability. ThermaZone is not meant to replace the program that medical professionals have prescribed
for their patients. Physician consultation before changing or discontinuing a recommended therapy or
treatment plan is strongly recommended. ThermaZone pads are not intended to come in contact with
breached or wounded skin.
CONTRAINDICATIONS
Absolute Contraindications for THERMOTHERAPY
Therapy should NOT be used in patients without medical supervision:
• If the patients have decreased skin sensitivity;
• If the patients are children, elderly, or incapacitated; and/or
• If the patients have poor circulation, vein ligation, recent skin grafts, or extremely low blood pressure.
Therapy should NOT be used in patients:
• Who are insensitive to Heat.
Absolute Contraindications for CRYOTHERAPY
Therapy should NOT be used in patients:
• Who have Raynaud’s disease.
• Who are children.
Absolute Contraindications for us of RANGE OF MOTION (ROM) BRACE
ROM Brace should NOT be used in patients:
• Who have moderate to severe ligament instabilities.
SAFETY INSTRUCTIONS
READ THIS FIRST • SAVE THESE INSTRUCTIONS • IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS CAREFULLY BEFORE USING THE THERMAL THERAPY DEVICE
CAUTION

Temperature; 4.5-50C
Humidity: 0-90%
Atmospheric Pressure: 50 kPa to 106 kPa
ALWAYS unplug the unit immediately after use and before storing.
ALWAYS drain the unit before Storage, according to the Preventative Maintenance instructions on
page 13. “Storage” means non-use for over three months.
DO NOT STORE or store where it can fall into a bathtub, shower, sink, water or other liquid.
Store the unit and pads in a cool, clean, dry space.
AVOID EXPOSURE to sunlight and high heat conditions for extended periods. Keep away from ames.
When removing and storing the pads or tubing assemblies, replace the caps on the end of the blue tubes.
Dispose of the unit and pads in a manner that is consistent with your federal, state, and local
laws and regulations.
Temperature: 16C-29.4C.
Humidity: 15-90%
Atmospheric Pressure: 70.0 kPa to 106.0 kPa
BEFORE CLEANING:
ALWAYS power off the unit and unplug the AC / DC power cords from the outlet and the unit before
cleaning. DISCONNECT the brace from the unit. Remove hinges from the brace.
TO CLEAN:
Unit can be cleaned with a neutral disinfectant wipe.
Braces can be cleaned with a neutral disinfectant wipe, soap-water or mild detergent. Rinse brace with
warm tap water and dry with a clean, lint-free cloth. Hinges can be hand washed in cold water with mild
detergent. Allow parts to air dry before re-assembly.
When used in accordance with the cleaning & disinfectant wipe manufacturer’s instructions for use, the
following cleaning & disinfection wipes do not adversely affect the appearance or performance of the
ThermaZone Unit or Brace:
DO NOT:
• use ANY chemical cleaning agents or products containing alcohol on unit, braces or hinges, except as
outlined above.
• wash the unit or hold under running water.
• spray the unit, braces or hinges with cleaning or degreasing sprays.
• scrub the unit, braces or hinges with brushes. DO NOT place unit or braces in autoclave sterilizer.
• attempt to sterilize the unit or braces
• clean the unit, braces or hinges using a laundry machine. Hand wash ONLY.
• dry unit, braces or hinges in machine dryer. Hang or line dry ONLY.
FREQUENCY:
Clean Unit anytime it becomes dirty or between uses with different patients.
Clean Brace anytime it becomes dirty or between uses on different patients.
Clean Hinges anytime they become dirty.
TRANSPORT, STORAGE & DISPOSAL
OPERATION
CLEANING
Cleaning & Disinfectant Wipe Manufacturer
CaviWipesTM Metrex Research
Super Sani Cloth®
Germicidal Disposable Wipe
Professional Disposables Internation, Inc. (PDI)

Accessories
THERMAZONE ALSO OFFERS
OPTIONAL ACCESSORIES.
BLUE TUBING ASSEMBLY
The Blue Tubing Assembly comes with every ThermaZone® device and is
sold separately as a replacement component for lost or damaged tubing.
The blue tubing assembly is 6’ feet in length and comes complete with
quick connectors to attach orthopedic pads and braces to the
ThermaZone device.
AUTO POWER CORD
The ThermaZone® Auto Power Cord allows the ThermaZone® device to
be used in any motor vehicle equipped with a 12 Volt DC power outlet.
Convenient to power ThermaZone® device when traveling.
CARRY & STORAGE BAG
The ThermaZone® Duffel comes with a foam insert to secure and protect
the ThermaZone® device. The main compartment has a U-shaped zipper
opening for easy access. The compact and easy to carry duffel has a
padded shoulder strap and is sized to hold the ThermaZone® device and
4 or more orthopedic pads.
The duffel has additional outside storage zipper accessory pockets to
hold accessories. The foam insert has a specic cut out to hold the dis-
tilled water bottle required to operate ThermaZone®.
HOSPITAL BED BRACKET
Metal powder coated bracket securely holds the ThermaZone® device
and attaches to patients’ hospital bed rail or standard 1” diameter
Equipment IV pole. Made in the U.S.A.
IV POLE WITH BASKET
48” Equipment IV pole has a 1” diameter pole with 5-point low center of
gravity base with heavy duty locking casters. Includes a chrome plated
basket with mounting hardware. Made in the U.S.A.
Basket Dimensions: 12” wide X 5 3/4” deep X 8” Tall
Bracket is sold separately. (Even though photo shows them together)

BEFORE YOU BEGIN:
Instruction and Safety Manual for Your
Thermal Therapy Unit
www.imeconcepts.com
Item # 003-99
Warning: Read this Manual before using this product.
Failure to follow the instructions in this Manual may result in injury.
Keep this Manual in a safe location for future reference.
This User’s Manual is also available at www.therma-zone.com.
ENGLISH
AVAILABLE THERMAL
THERAPY PADS
SHOULDER
PAD
STANDARD WARRANTY:
Limited 3 Month Warranty on ThermaZone Pads and Braces.
See Instruction and Safety Manual for full warranty details.
Read Instruction and Safety Manual included
with your ThermaZone unit.
The ThermaZone Instruction and Safety Manual is also available at
www.therma-zone.com.
© 2020 Innovative Medical Equipment, LLC #103-120 v1 11/2020
BACK / HIP
PAD
ANKLE
PAD
KNEE / ELBOW
PAD
FRONT & SIDE
HEAT PAD
EYE
PAD
OCCIPITAL
PAD
UNIVERSAL
PAD
INNOVATIVE MEDICAL
EQUIPMENT, LLC
23950 Commerce Park
Cleveland, OH 44122 USA
[phone]
[phone]
www.therma-zone.com