THERMA 003-99 Instruction Manual

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

2
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
!

3
SAFETY INSTRUCTIONS
U.S. Patent 9,238,109 • All Rights Reserved
Innovative Medical Equipment, LLC
23950 Commerce Park, Suite 100
Beachwood, Ohio 44122 USA
1 [phone]
CAUTION
!
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 minor or
moderate injury, or damage to the ThermaZone Unit or Pads:
• DO NOT position the unit so that it is di󰀩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 tra󰀩c areas and where it will not be tripped over.
• DO NOT drop the unit or pads.
• DO NOT operate or store the unit or pads near pets.
• Pads are NOT sterilized. DO NOT place Single Patient Use Pads in an autoclave or attempt to sterilize. •
Before each use, make sure pads are not damaged, punctured or leaking.
• DO NOT puncture the pads.
• To avoid any adverse e󰀨ects to your health or skin, shut o󰀨 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.
• Single Patient Use Pads are designed for up to 4 weeks of use.
• Single Patient Use Pads are only designed for use by one patient.
CONTRAINDICATIONS
Contraindications for THERMOTHERAPY
Therapy should NOT be used in patients without medical supervision:
• If the patients have decreased skin sensitivity or are insensitive to heat;
• 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.
Contraindications for CRYOTHERAPY
Therapy should NOT be used in patients without medical supervision:
• If the patients have decreased skin sensitivity or are insensitive to cold; and/or
• If the patients are children, elderly, or incapacitated;
Therapy should NOT be used in patients:
• Who have Raynaud’s disease; and/or
• Poor circulation

4
THERMAZONE INTENDED USE
ThermaZone is intended to provide heating or cooling e󰀨ect at controlled temperatures through
water-circulating, anatomically designed pads for the application of noninvasive localized thermal
therapy.
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.
CONTROL PANEL
We recommend you setup and familiarize
yourself with operating the ThermaZone
unit before you need to use it. Open the
carton and remove the packaging material
around the unit. Place the unit on a solid,
at surface. Ensure that the top, front and
back vents on your unit have six inches of
space surrounding them.
GETTING STARTED
NOTE: Water from your tap or water in
a bottle labeled as Spring or Puried
water is not the same as distilled water.
Tap water, spring water, puried water
and even water ltered in your home
ltration system may still contain
many types of suspended pollutants,
microscopic chemicals, toxins and
other contaminants. Distilled water is
necessary to prevent any damage caused
by minerals present in tap water and
most bottled waters.
1
• Lift the handle.
• Gently peel back black rubber fill cap.
• Slowly pour distilled water into the
reservoir under the fill cap (water should
drain through hole in the center of
the reservoir).
• Ensure you have filled between
“MIN” and “MAX” levels on the
water level indicator to maintain
optimal performance.
DISTILLED WATER RESERVOIR
HANDLE (RAISED)
CONNECTOR PORTS
AC/DC ADAPTER PLUG
FILL THE RESERVOIR WITH
DISTILLED WATER
5 preset timer options. Lightweight, easy-
to-carry handle.
ON/OFF control panel
with mode and temperature
control buttons.
Adapter plug for AC/DC power
supply or auto power cord.
Lighted comfort level
window display.
Connector Ports for
easy connection of
relief pads.
COMFORT LEVEL
DISPLAY WINDOW
Power ON/OFF Preset Timer Select
HEAT COOL
Temperature Select Levels 1–10
Select Comfort Level
MAX
MI N
(optional)

5
CONNECT A RELIEF PAD
2
• Remove the white caps from the end of the white connectors on the tubing assembly.
• Attach the white connectors to the connector ports on the front of the unit, by aligning the
tabs and turning clockwise.
NOTE: Some pads come with the tubing assembly pre-attached to the pad. However, other
pads may require you to attach the tubing assembly to both the unit and the pad. Insert the
connector on the pad into the port on the tubing assembly until you feel the connector click and
lock into place.
REFILL THE RESERVOIR
4
• Pour additional distilled water into the reservoir.
• Monitor water ll level over the next minute to make sure the water level
settles between the “MIN” and “MAX” lines.
• Close the black rubber ll cap.
! BE SURE WATER
LEVEL IS BETWEEN
MIN AND MAX !
If this is the rst time you are using the unit, or the rst time you have
connected a relief pad, the water from the reservoir will be pumped into the
chambers of the pad during Step 3. At this time, you will need to rell your
unit with distilled water.
POWER ON YOUR THERMAZONE UNIT
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”).
AC/DC
ADAPTER
PLUG
ConnectorPort
MAX
MI N
Connector
Ports
Connector
MODE
HE AT COOL
COMFORT LEVEL

6
5SELECT PRESET TIMER MODE (OPTIONAL)
Your unit comes equipped with 5 Preset Timer Modes. If you do not want to select a
Preset Timer Mode for your current therapy session, bypass Step 5 and move onto
Step 6. If you do want to select a Preset Timer Mode you must select the timer option
before you select the temperature mode.
Be sure to review the General Precautions in the ThermaZone Instruction and Safety
Manual Section 6 before selecting a Temperature Mode and Comfort Level.
Push the button to set the timer.
There are ve preset timer options.
The option will be displayed in the comfort level window.
Push the button up to ve times to get to desired option.
The preset options are as follows: MODE
HEAT COOL
COMFORT LEVEL
MODE
HEAT COOL
COMFORT LEVEL
MODE
HEAT COOL
COMFORT LEVEL
MODE
HEAT COOL
COMFORT LEVEL
MODE
HEAT COOL
COMFORT LEVEL
Presets 4 and 5 are automatic settings that provide continuous therapy until you manually
power o󰀨 the unit or switch modes. The unit counts down and automatically restarts in the
original selected mode.
Note: You must set the timer before you select the temperature mode if you want to use any of
the preset timers.
Once you have selected the temperature mode you can check the remaining time on the timer
by pushing the currently selected “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.
SPECIAL NOTES ON TIMER OPTIONS
*In Program Pause (“PP”) mode, your unit will remain powered on.
However, no power will be applied to the heating/cooling component of the
unit and the water will begin returning to the ambient temperature. You will
need to manually power o󰀨 the unit at the conclusion of your therapy.
Preset 1: Window displays “ ”
10 minutes in selected mode,
then unit turns o󰀨 automatically.
Preset 2: Window displays “ ”
20 minutes in selected mode,
then unit turns o󰀨 automatically.
Preset 3: Window displays “ ”
30 minutes in selected mode,
then unit turns o󰀨 automatically.
Preset 4: Window displays “ ”
30 minutes in selected mode, then
30 minutes in Program Pause (PP)*
mode. (Repeats continuously until unit
is manually turned o󰀨)
Preset 5: Window displays “ ”
30 minutes in selected mode, then
60 minutes in Program Pause (PP)*
mode. (Repeats continuously until unit
is manually turned o󰀨)

7
6CHOOSE YOUR DESIRED TEMPERATURE
MODE AND COMFORT LEVEL
HEAT: To use the heating function, press the red “HEAT”
button on the control panel. Adjust the temperature by
pushing the plus (+) and minus (–) buttons. Temperature
level 1 will provide minimum heat, and temperature level 10
will provide maximum heat. We suggest that you start the
unit at level 5 and make adjustments depending on your
comfort level.
COOL: To use the cooling function, press the blue “COOL” button on the control
panel. You can adjust the temperature by pushing the plus (+) and minus (–) buttons.
Temperature level 1 will provide minimum cooling e󰀨ect while temperature level 10
will provide the maximum cooling e󰀨ect.
Note: Temperature levels can vary based on the ambient temperature.
As a safety precaution the pad temperature will not rise above 125˚F (51.7˚C), the
unit has a thermal cut-o󰀨 to prevent overheating. We suggest that you start the
device at level 5 and make adjustments depending on your comfort level.
FOR BEST RESULTS: Once you have set up your unit and are ready to begin
therapy, you will achieve the best results if you follow these simple tips:
IF APPLYING COOL THERAPY:
Select and attach your desired relief pad and turn on your unit. Set the cool comfort
level to ‘10’ and leave the pad open on a at surface for 10 minutes before applying
to your body. This will enable the unit to get cool without ghting the body’s natural
temperature of 98˚ F (36.7˚C).
IF APPLYING HEAT THERAPY:
Select and attach your desired relief pad and turn on your unit. Choose your desired
comfort level and place the pad on the body to begin therapy immediately. Your body
heat will actually help the unit reach your desired heat temperature more rapidly.
IF GOING FROM HEAT THERAPY TO COOL THER APY:
To initiate contrast therapy from the HEAT mode, it is recommended that you remove
the pad from the body and leave at on a surface for approximately 10 minutes.
Simply push the COOL button and the device will begin to count down (from 60) for
3 minutes and then begin in the alternate mode. Removing the pad from the body
will enable the cool temperatures to be achieved more rapidly.
IF GOING FROM COOL THERAPY TO HEAT THER APY:
To initiate contrast therapy from the COOL mode, it is not necessary to remove the
pad from the body. Simply push the HEAT button and the device will begin to count
down (from 60) for 3 minutes and then begin the alternate mode.
GENERAL PRECAUTIONS:
Tolerance to thermal therapy di󰀨ers according to tissue type (body part and tissue
density), temperature, and exposure time. This is patient specic and each patient
must exercise caution and judgment when using the ThermaZone and cease use if
therapy becomes uncomfortable or skin damage is noticed or suspected.
WARNING: 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.
MODE
HEAT COOL
COMFORT LEVEL
5

8
WARNING: Decreased sensation from the body’s natural adaptation to heat
may cause you to tolerate a 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)
WARNING: ThermaZone pads are intended to be used without any additional
ointments, crèmes, 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.
The following recommendations may help prevent thermal injury to specic tissues*:
Temperature
(C˚) Max
Temperature
(F˚) Max
Maximum Suggested Time
40 104 Safe for prolonged use (2 hours or longer)
45 113 30 minutes
46 115 20 minutes
47> 116
WARNING: May cause skin burn if used greater than 10 minutes.
Recommended: 1) Use of towel or thin barrier between the skin and
pad to protect the skin. 2) Frequently monitor skin to avoid tissue
damage if maximum temperature settings are desired.
*Data on le
ThermaZone HEAT Mode Temperatures**
Comfort Level 12345678 9 10
Temperature (C˚) 24.4 28.3 31.1 33.9 36.7 39.4 42.8 46.1 49.4 51.7
Temperature (F˚) 76 83 88 93 98 103 109 115 121 125
**Temperatures represented are from the smallest ThermaZone pad and may be slightly
lower on larger pads.
APPLY YOUR PAD
7
Each pad has hook and loop closures with elastic straps for a comfortable t. The straps
should be snug enough to hold the pad in place without discomfort. Place the pad in a
comfortable position so it does not move around easily. Pads can be applied to intact skin,
used over clothing or over a thin barrier.
NOTE: When pads are applied directly to skin, the temperature will feel more intense.
EXAMPLE SHOWN FROM “SHOULDER PAD” INSTRUCTION MANUAL.
EACH INDIVIDUAL RELIEF PAD COMES WITH A FULL SET OF INSTRUCTIONS.

9
8SIT BACK AND RELAX
ADDITIONAL OPERATING INSTRUCTIONS
9
You are now ready to enjoy the comfort and convenience of your thermal therapy unit.
If the therapy becomes uncomfortable, remove the pad immediately and adjust the
temperature level. Allow the pad temperature to reset for 10–15 minutes before reapplying.
To adjust temperature during therapy, push the (+) or (–) buttons to increase or decrease
the temperature. To check the remaining time in a preset timer mode, push the currently
selected “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.
AFTER INITIAL USE – SAME PAD: After following the Quick-Start Guide, or
the 8 steps in this manual for initial setup of the unit, each subsequent use with the
SAME PAD is a simple 6 step procedure: 1) Plug in the unit, 2) monitor the water level
indicator to make sure the current distilled water level is between “MIN” and “MAX,”
3) press the ON/OFF button to turn the unit on, 4) set timer (optional), 5) set your
desired temperature level, 6)apply the pad to the appropriate area requiring relief.
CHANGING TEMPERATURE MODES/CONTRAST THERAPY: Some users nd
both heat and cool treatments benecial in relieving their pain. Changing the cooling and
heating modes during the same use requires a 3 minute delay to prevent damage to the
components of the unit. When the unit is in either mode, and you press the button on the
control panel corresponding to the other mode, a timer will immediately be displayed on
the control panel that will count down from 60 to 0. Once the timer reaches zero, the other
mode will automatically start. At this time, you can select the temperature level you prefer
and continue using as previously directed. Refer to Step 6 for best results when using
contrast therapy.
DURING USE: WE DO NOT RECOMMEND USING THE UNIT FOR LONGER
THAN 30 MINUTES AT A TIME. After 30 minutes, take a break and then reapply.
If the therapy becomes uncomfortable, remove the pad and adjust the temperature
level. Allow the pad temperature to reset for 10–15 minutes before reapplying. For
safety reasons, the pad is not meant to be worn while sleeping, bathing or showering.
Please read the safety instructions thoroughly before using the unit (see page 2).
ENDING THERAPY: Once your surface therapy is complete, or if you would like to
discontinue using the unit, press the on/o󰀨 button and allow the pad to return to room
temperature before storing it. Always unplug the unit after each use.

10
THERMAL THERAPY PADS
Once the unit is plugged in, the power is turned on, the pad is attached, you’ve selected
your desired time mode, and you’ve selected your desired temperature, touch the inside of
the pad (the channels will be showing) with your hand to ensure the temperature is not too
warm or cold. When you are satised with the pad temperature, t the desired pad per the
instructions that accompanied the pad. The straps should be snug enough to hold the pad
in place, yet loose enough so that there is no discomfort. The goal is to have the pad in a
comfortable position so it does not move around easily.
Individual pads work in conjunction with the ThermaZone Therapy technology and
are interchangeable with the unit. Pads are made of a soft, exible material for
maximum comfort.
FRONT AND SIDE
HEAD PAD
EYE PAD OCCIPITAL (BACK
OF HEAD) PAD
UNIVERSAL PAD SHOULDER PAD BACK PAD
KNEE PAD/ELBOW
PAD
ANKLE PAD

11
TRANSPORT, STORAGE & DISPOSAL
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 Preventive 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.
OPERATION
Temperature: 16C-29.4C.
Humidity: 15-90%
Atmospheric Pressure: 70.0 kPa to 106.0 kPa
CLEANING
BEFORE CLEANING:
ALWAYS power o󰀨 the unit and unplug the AC / DC power cords from the outlet and the unit
before cleaning. DISCONNECT the pad from the unit.
TO CLEAN:
Unit can be cleaned with a neutral disinfectant wipe.
Pads can be cleaned with a neutral disinfectant wipe, soap-water or mild detergent. Rinse pads
with warm tap water and dry with a clean, lint-free cloth.
When used in accordance with the cleaning & disinfectant wipe manufacturer’s instructions for use,
the following cleaning & disinfection wipes do not adversely a󰀨ect the appearance or performance
of the ThermaZone Unit or Pads:
DO NOT:
• use ANY chemical cleaning agents or products containing alcohol on unit or pads,
except as outlined above.
• wash the unit or hold under running water.
• spray the unit or pads with cleaning or degreasing sprays.
• scrub the unit or pads with brushes. DO NOT place unit or pads in autoclave sterilizer.
• attempt to sterilize the unit or pads.
• clean the unit or pads using a laundry machine. Hand wash ONLY.
• dry unit or pads in machine dryer. Hang or line dry ONLY.
FREQUENCY:
Clean Unit anytime it becomes dirty or between uses with di󰀨erent patients.
Clean Reusable Pad anytime it becomes dirty or between uses on di󰀨erent patients.
Clean Single Patient Use Pad anytime it becomes dirty.
Cleaning & Disinfectant Wipe Manufacturer
CaviWipesTM Metrex Research
Super Sani Cloth®
Germicidal Disposable Wipe
Professional Disposables Internation, Inc. (PDI)

12
SERVICE LIFE
As long as the Unit is operated and maintained in accordance with this ThermaZone
Safety & Instruction Manual, the service life can last up to three (3) years. Service life
is not to be confused with the Standard Warranty.
TROUBLESHOOTING
FAIL SAFE SWITCH FUNCTION: If you nd that the cooling or heating system is not
working properly on your unit, it is possible that the safety switch has been activated
because the unit was getting too hot. This may be caused by a blockage of the air
intake vent that is used to cool the pump. If this occurs, turn the unit o󰀨 and make sure
that there are no objects (e.g. clothing) within six inches of the unit. The switch will
automatically reset after a few minutes. Upon resuming use, ensure that the power of
the unit is set to a lower level temporarily (level 5). NEVER use a power adapter other
than the one provided with the unit.
ENSURE MAXIMUM HEAT OR COOL: Some users have noticed that wearing the
pad too tightly can reduce the maximum heat and cool that the unit can achieve. If this
happens, try loosening the pad and resuming use.
IF UNIT IS NOT COOLING: Check the water level and lay the pad at. Make sure the
water is owing properly into the pad and the pad channels are rm to the touch.
OVERFILLING THE RESERVOIR: When lling the unit with distilled water, make sure
to pour water into the water reservoir portion of the unit only (under the rubber cap). If
too much water is poured in at once, it may not drain properly into the unit’s reservoir. If
this happens, either tip the unit to one side or soak the excess water up with a towel to
expose the air hole. Then, resume lling the unit with water.
ADAPTER MALFUNCTION: If the AC / DC adapter does not turn on, the adapter could
be defective or overused.*
PAD DISCOLORATION: Pads may become discolored over time. Discoloration is due
to the water running through a small portion of copper tubing within the device, which
causes the pad to become discolored over extended periods of time. Discoloration is
not bacteria, fungi, or algae, and is not harmful to the user.
POWER FUSE FAILURE: There is a possibility that, over time, the power fuse to your
unit may need to be replaced.*
YOU SHOULD NOT ATTEMPT TO FIX THE UNIT YOURSELF OR ALLOW
SOMEONE TO FIX IT. ATTEMPTING TO REPAIR THE UNIT YOURSELF WILL
RESULT IN AN INVALID WARRANTY.
*If part of your unit needs to be repaired or replaced, please contact us at
[e-mail] or 1-877-901-9663

13
PREVENTIVE MAINTENANCE
FLUSHING THE THERMAZONE SYSTEM:
Under normal use, the internal water can become contaminated with dust and water
precipitant. This is a normal occurrence and periodic ushing of the system may
help alleviate potential clogging of the water reservoir and internal plumbing system.
Flushing of the system once a month is adequate, but heavy use may require more
frequent ushing.
PREPARING THE SYSTEM TO BE FLUSHED:
Follow steps 1-3 from the GETTING STARTED section of this guide.
• When removing and storing the pads or tubing assemblies, replace the caps on the
end of the blue tubes.
After steps 1-3 are complete, the ThermaZone system is ready to begin the ushing
process.
NOTE:
• Do not apply heat or cooling during the ushing process
• Fill the system with only distilled water
• Ensure the system is properly grounded
STEP 4: DISCONNECT TUBE
• Turn the power o󰀨 but leave
the unit plugged in. With the unit
facing you, disconnect the blue
tube connected to the right-side
connector port.
STEP 5: OPEN VALVE
• Please note, the blue tubing connector
contains a spring-loaded valve. The valve
will need to be pressed in during the ushing
process. Simply press the valve against the
at surface of a sink or basin to open value
so that it will drain.
DISCONNECT TUBE SPRING-LOADED
VA LVE
PRESS THE VALVE
AGAINST A FLAT SUR-
FACE TO OPEN IT.
STEP 6: SYSTEM FLUSH
• You are now ready to ush the system. With the connector pressed against the surface,
press the ON/OFF button to turn on the ThermaZone unit. The pump and fan will begin
to operate and the display window will read ON. Once the pump begins to operate, water
will begin owing out of the depressed connector. When full, the reservoir holds approxi-
mately 60 mls of distilled water and the pump should expel the water within 1 minute.
WARNING: Do not consume water removed from the ThermaZone device.
• After the water stops owing, release the valve and press ON/OFF to turn the power o󰀨. At the
back of the unit, the red ball within the reservoir should be at or below the MIN level indicator.
• It is advisable to ush the system multiple times.
STEP 7: REATTACH TUBE
• Once the ushing process is complete, attach the unattached pad/tubing connector to the
right port connector, and rell the reservoir with distilled water. The system is ready for use.

14
STANDARD WARRANTY
ThermaZone Unit & Pads
Limited 1 YEAR WARRANTY on the ThermaZone Thermal Therapy Unit
Limited 3 Month WARRANTY on ThermaZone Pads
Innovative Medical Equipment,LLC warrants the ThermaZone Unit, if properly used
as stated above, will be free from defects in material and workmanship for a period
of (6) months after the date the ThermaZone unit is purchased. Innovative Medical
Equipment,LLC warrants the ThermaZone pads, if properly used as stated above,
will be free from defects in material and workmanship for a period of (3) months after
the date the ThermaZone Pad is purchased. To obtain warranty service on your unit
and pads, e-mail us at [e-mail] or call 1-877-901-9663 for further
information. No COD’s will be accepted.
Innovative Medical Equipment, LLC does not authorize anyone, including, but not
limited to, retailers, the subsequent consumer purchaser of this product from a retailer
or remote purchaser, to obligate Innovative Medical Equipment, LLC in any way beyond
the terms set forth herein.
This warranty does not cover damage caused by misuse or abuse, accident; the
attachment of unauthorized accessories; alteration of the unit; improper installation;
unauthorized repairs or modications; improper use of electrical/ power supply; loss of
power; dropped unit; malfunction or damage of an operating part from failure to provide
manufacturer’s recommended maintenance, transportation damage; theft; neglect;
vandalism;or environmental conditions; loss of use during the period the product
is at the repair facility or otherwise awaiting parts or repair; or any other condition
whatsoever that are beyond the control of Innovative Medical Equipment, LLC.
This warranty is e󰀨ective only if the product is operated in the country from which the
product was purchased. If the product is modied in any way, including but not limited
to, altering the power supply, it will not be covered under this warranty.
THIS WARRANTY PROVIDED HEREIN SHALL BE THE SOLE AND EXCLUSIVE
WARRANTY. THERE SHALL BE NO OTHER WARRANTIES EXPRESSED OR
IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR FITNESS OR ANY OTHER OBLIGATION ON THE PART OF INNOVATIVE
MEDICAL EQUIPMENT, LLC WITH RESPECT TO PRODUCTS COVERED BY
THIS WARRANTY. INNOVATIVE MEDICAL EQUIPMENT, LLC SHALL HAVE NO
LIABILITY FOR ANY INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES.
IN NO EVENT SHALL THIS WARRANTY REQUIRE MORE THAN THE REPAIR
OR REPLACEMENT OF ANY PART OR PARTS WHICH ARE FOUND TO BE
DEFECTIVE WITH IN THE EFFECTIVE PERIOD OF THE WARRANTY. NO REFUND
WILL BE GIVEN. IF REPLACEMENT PARTS ARE DEFECTIVE MATERIALS ARE
NOT AVAILABLE, INNOVATIVE MEDICAL EQUIPMENT RESERVES THE RIGHTS
TO MAKE PRODUCT SUBSTITUTIONS IN LIEU OF REPAIR OR REPLACEMENT.
UNLESS OTHERWISE AGREED TO IN WRITING BY INNOVATIVE MEDICAL
EQUIPMENT, LLC, THIS LIMITED WARRANTY SHALL APPLY ONLY TO THE
ORIGINAL PURCHASER OF THE THERMAZONE UNIT AND PADS AND IS NON-
TRANSFERABLE.
This warranty does not extend to the purchase of opened, used, repaired, repackaged,
and/or resealed products, including but not limited to sale of such products on internet
auction sites and/or sale of such products by surplus or bulk re-sellers. Any and all
warranties or guarantees shall immediately cease or terminate as to any products
or part thereof which are repaired, replaced, altered, or modied, without the prior
express and written consent of Innovative Medical Equipment, LLC. This warranty
provides you with specic legal rights. Due to individual country regulations, some
of the above limitations and exclusions may not apply to you. For more information
regarding your unit, please visit www.imeconcepts.com.

15
REGISTER YOUR PRODUCT ONLINE
Please complete the Warranty Registration for the ThermaZone Unit and the
ThermaZone Pads online at www.imeconcepts.com. You will need the following
information to complete your Warranty Registration: The ThermaZone unit model # and
serial # are located on the bottom of the unit. The pad model # and lot # are located on
the inside of the pad. Simply go to www.therma-zone.com and submit the form with the
required information.
CONTACT
For assistance, if needed, in setting up, using or maintaining the ThermaZone Unit or
Pads, or to report unexpected operation or events, please contact:
USA: Innovative Medical Equipment, LLC
1 [phone]

www.therma-zone.com
#103-32 v7 04/2020
ThermaZone is a trademark of
Innovative Medical Equipment, LLC © 2020
Symbol Title
Direct Current
Alternating Current
Warning/Caution
Operating Instructions
Type BF Applied Part. Classication
required for medical devices that come
in direct contact with the patient.
Manufacturer
Reference symbol for specic product
or catalog number.
Type of power outlet required to
properly operate the device.
IP 22 Protection against solid objects greater
than 12.5mm and against drops of
liquid falling for short periods of time.
Class II Equipment
Waste Electrical and Electronic
Equipment (WEEE) Symbol Product
owners should refer to their specic
state and government regulatory
guidelines for proper disposal.
SAFETY & INSTRUCTION LABEL
ON THE UNIT (SEE BOTTOM)
GENERAL SYMBOLS
& SAFETY SIGNS
Innovative Medical Equipment, LLC
23950 Commerce Park, Suite 100
Beachwood, Ohio 44122 USA
1 [phone]
Before using device, read Instruction Manual and Quick-Start Guide
for important instructions and safety information.
INNOVATIVE MEDICAL EQUIPMENT, LLC
INPUT: 12V , 6A
IP22
Use ThermaZone with power supply
Specified by Manufacturer
www.imeconcepts.com 003-99
PADS
+
-
U.S. Patent No. 9,283,109
UNDER PENALTY OF LAW DO NOT REMOVE THIS TAG
READ THE INSTRUCTION AND SAFETY MANUAL BEFORE USING
PRODUCT SHOULD NOT BE USED BY PERSONS INSENSITIVE TO HEAT
FAILURE TO FOLLOW THE INSTRUCTIONS AND SAFETY MANUAL MAY RESULT IN
THE RISK OF FIRE AND INJURY - INCLUDING DEATH
BURNS CAN RESULT FROM IMPROPER USE
NEVER USE WHILE SLEEPING, UNDER BLANKETS OR OTHER MATERIALS
DO NOT USE FOR MORE THAN 30 MINUTES AT A TIME
DO NOT USE NEAR WATER OR WHEN WET
REMOVE IF TEMPERATURE BECOMES UNCOMFORTABLE
NOT TO BE USED BY CHILDREN WITHOUT MEDICAL SUPERVISION
DO NOT USE THIS PRODUCT AS A SUBSTITUTE FOR MEDICAL ATTENTION.
WARNING
203-102v 5
CAUTION: 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.