Anodyne Therapy Freedom 300 User manual

Important Safety Information
and Instructions
Read Entire Booklet Before Operating

2
Dear Valued Customer:
Thank you for choosing the Anodyne Freedom 300 for treating
your foot/lower leg pain.
Using our Freedom 300 could not be any easier. Simply place the
Calf Therapy Pad over your calf and the Foot Therapy Pad under
your foot and then hold in place with Anodyne attachment system.
Next turn on the system and receive 30 minutes of hands-free
soothing relief. That’s it!
Read this entire manual before using the Freedom 300. This
will maximize your satisfaction and your safety!
All of us at Anodyne look forward to helping you feel better. Please
call our Customer Service Department at 1-800-521-6664 if you
ever have a question about your Freedom 300.
Sincerely,
Craig Turtzo
Craig Turtzo
President and CEO
Anodyne Therapy, LLC

3
TABLE OF CONTENTS
Summary: Warnings and Cautions ...................................................... 4
Summary: Basic Operating Instructions ............................................ 5
General Warnings and Precautions.................................................... 6-8
Purpose of Device (Indications for Use)............................................... 8
Components (Device and Parts Description)..................................... 9
Environmental Conditions Aecting Use ........................................... 9
Set Up Instructions ....................................................................................10
Operating Instructions...................................................................... 11-14
Treatment Frequency ...............................................................................14
Cleaning ........................................................................................................15
Maintenance ...............................................................................................16
Storage...........................................................................................................16
Troubleshooting.........................................................................................17
Warranty and Return Policy....................................................................18
Index ..............................................................................................................19

4
Warnings and Cautions
This device emits heat and may cause burns. Risk of burns is
reduced in the following ways:
• Never use pain patches like Duragesic®or topical heating agents
like BenGay®or Icy Hot®before, during, or after treatment.
• Stop treatment if the Treatment Pads feel too warm for comfort.
• Apply the Treatment Pads exactly as described throughout this
manual. Do not overtighten attachment straps or stand on Foot
Treatment Pad as the LED surfaces may reach a max temperature
of 127°F.
• Do not use if you have a sensitivity to silver metal.
This is an electrical device. To avoid electrical shock:
• Do not use this system in water, near water or while wet.
• Do not use this system if electrical cords are frayed or you can see
exposed wires.
• Do not saturate, soak or immerse system or components in water
or liquid.
• Do not store this system in a wet or excessively damp location
as this may cause rust or corrosion of electrical components or
wiring. Damage to the electrical components could result in
electrical shock or could result in the device not functioning
properly.
SUMMARY
!
This summary is not intended to replace the complete
user instructions. The entire manual should be read and
understood before operating the Freedom 300.

5
Basic Operating Instruction
Set Up: Plug Power Supply into an electrical outlet and depress
the On/O Switch on the Control Unit to the On position. If the
Green Indicator Light turns on the device is operational. Turn
the On/O Switch to the O position.
Put the Calf Treatment Pad over the back of your calf:
Place the Calf Treatment pad over the back of your calf with the
diode clusters resting on the back of your calf. Hold the short
side of the top attachment strap against your shin. Wrap the
longer side of the top attachment strap around your leg and over
the short side of the attachment strap and press the Velcro end
to hold in place. Follow the same procedure with the bottom
attachment strap. The attachment straps should only be tight
enough to hold the treatment pad-do not overtighten.
Put the Foot Treatment Pad on the bottom of your foot: Loosen
the attachment strap of the Sandal so you can slide your foot
easily into the Sandal. Slide your bare forefoot (do not wear socks
or stockings) into the sandal, tighten to hold in place on your
foot.The back of your heel should be positioned at the rounded
side of the Foot Treatment Pad.
Warning: Do not over tighten Attachment Straps or stand on
Foot Treatment Pad as this may increase risk of burns.
Turn on Control unit to begin treatment: Depress the On/O
switch on the Control Unit to begin treatment (note: the green
indicator light will turn green for 30 minutes. The unit will
automatically turn o after 30 minutes of operation. Remove at
the end of the 30 minutes (when the unit turns o).
Warning: Immediately remove Treatment Pads if they feel too
warm for comfort as you may be at an increased risk for burn.
Remove Treatment Pads at the end of treatment: Disengage
the calf attachment straps and remove the Calf treatment pad.
Slip the foot sandal of your foot. Turn o Control Unit, unplug
from electrical outlet, and store in a safe place away from children
and pets.
!
!
SUMMARY

6
!
WARNING: Use carefully. May cause serious burns. Do
not use over sensitive areas or in the presence of poor
circulation. The unattended use of the Freedom 300 by
children or incapacitated persons may be dangerous.
To minimize the risks of burns, please read and
follow these important precautions:
The Anodyne®Freedom 300 should not be used directly over or near the
womb during pregnancy or directly over an active cancer lesion. The
eects of the Freedom 300 (like other modalities) with these types of
conditions are unknown.
Treatment Pad
Placement
• Only place the Treatment Pads on the back of
the calf and on the bottom of the foot. Treating
other areas with less circulation may increase the
likelihood of a burn.
Treatment Pad
Pressure
• Do not stand on or put excessive pressure on
either of the Treatment Pads during treatment.
Treatment Pad
Warmth
• It is normal to experience a slight warmth during
treatment. If any of theTreatment Pads feel too hot
for comfort, stop your treatment and call 1-800-
521-6664.
Skin Color
Changes
• It is normal for the treated area to be slightly
pink after treatment. However, if area is red like a
sunburn and stays that way for more than 8 hours
- do not treat again prior to contacting 1-800-521-
6664.
Topical Agents
• Do not use Treatment Pads over pain patches
like Duragesic®, or residual of; or topical heating
agents like BenGay® or Icy Hot®.
Other
• Do not saturate, soak, or immerse components in
water or liquid.
• Do not use the Freedom 300 if you have a
sensitivity to silver metal.
• Make sure your feet and legs are thoroughly dry
before use.
CONTRAINDICATIONS
GENERAL WARNINGS AND PRECAUTIONS

7
CAUTION: This is an electrical device and can cause
electrical shock.
Electrical Precautions
• The Control Unit is powered by a certied external transformer,
part number SM36DU09GSTR, input rated 100V to 240V AC, 50 -
60 Hz, 1.0A, output rated 9V DC, 3.0A max.The device is intended
to be plugged into a standard household electrical receptacle.
• Portable and mobile RF communications equipment can aect
the proper operation of medical electronic equipment. Call 1-800-
521-6664 before using this device if you, or any other member of
your family, is using other medical electronic equipment in your
home.
• Like any other electrical device, do not use the Freedom 300 in
water, near water or while wet. Use of the Freedom 300 in these
situations could cause electrical shock.
• Do not use a portable electric generator as a power source as this
may damage the electrical components of your Freedom 300.
• The Freedom 300 is an electronic device in which a portion of
the electronics may be hazardous. As such, the device should be
disposed of in an environmentally responsible manner. The device
should be disposed of in a hazardous waste management facility
in your local area at the end of its useful life.
!
Markings and Symbols
Caution, consult accompanying documents
OO (power: disconnection from the mains)
IOn (power: connection to the mains)
Alternating Current
Direct Current
Dispose at hazardous waste facility
Applied parts type B
!
________
- - - - - - - -
GENERAL WARNINGS AND PRECAUTIONS

8
GENERAL WARNINGS
• The Anodyne®Freedom 300 has been designed for single
patient use only. Sharing this device with others may result in
the spread of bacteria, viruses and other micro organisms from
one person to another, and may spread disease.
• If there is an open wound present in the treatment area, cover
the Treatment Pads or your aected foot or leg with a clear
plastic barrier (clear plastic wrap or clear plastic bag) to keep
the Freedom 300 clean.
• Do not leave your Freedom 300 unattended around small
children or pets. This could lead to serious shock, cuts and or
infections.
• Do not use if device materials cause skin irritation.
PURPOSE OF THE DEVICE (INDICATIONS FOR USE)
• The purpose of the Anodyne®Freedom 300 is to promote the
temporary relief of pain, stiness and muscle spasm and for
temporarily increasing blood circulation to the lower leg and
foot.
!
NOTE: When the Freedom 300 is turned on
(indicator light turns green), it will deliver
a 30 minute treatment cycle and then
automatically turn o (the indicator light will
turn from green to unlit).
GENERAL WARNINGS AND PRECAUTIONS

9
The Anodyne®Freedom 300 includes a Calf Treatment Pad with
Attachment Straps and a Foot Treatment Pad with an Attachment
Sandal, Control Unit and Power Supply.
Environmental Conditions Aecting Use
• Operating temperature: 0° to 40° C (0° to 104° F)
• Storage Temperature: -20° to 85° C (-4° to 185° F)
• Relative Humidity 5% to 95% Non-Condensing
Do not operate in a wet environment
as this may cause electrical shock.
.
!
Upper
Attachment
Strap
Calf Treatment Pad
Lower
Attachment
Strap
Foot Treatment
Pad
Control
Unit
On/O
Switch
Indicator
Light
COMPONENTS
Attachment
Sandal

10
STEP 1 :Remove the system from the packaging and
protective plastic bag. The plastic bag may be discarded or
retained for product storage between uses.
STEP 2: Read the entire instruction manual prior to rst use.
STEP 3: Remove socks or other hosiery.
STEP 4: Place the Control Unit on the oor or on a table
next to your seat where you will receive your treatment.
Be sure there is an electrical outlet close by. The Freedom
300 is portable and does not have to be set up in the same
location each time.
STEP 5: Plug the Power Supply into an active electrical
outlet.
!
Note: If you do not set up the Freedom 300 as directed, it will not
function properly but there are no other adverse consequences.
Warning: If you can see any exposed wires in the electrical cords
or their connection, discontinue use and call 1-800-521-6664.
Exposed wires may be unsafe and cause electrical shock.
SETTING UP YOUR FREEDOM 300
INSTRUCTIONS FOR USE

11
STEP 1: While the system is turned OFF, for your safety, visually
inspect the system to make sure that none of the electrical cords are
frayed and that there are no exposed wires.
STEP 2: Put on the Calf Treatment Pad – detailed in Steps 2a-2b
below.
Step 2a: Place the Calf Treatment Pad over the back of your calf with
the diode clusters resting on the back of you calf.
!
Note: For optimal results the side
of Calf Treatment Pad with 4 diode
heating clusters must be facing
towards the back of the knee,
while the side with 2 diode heating
clusters should be facing towards
the heel.
Top
Bottom
OPERATING YOUR FREEDOM 300
Warning: The Freedom 300 emits heat and may cause burns! If
either the Calf Treatment Pad or Foot Treatment Pad feels too hot,
immediately remove both Treatment Pads and stop treatment
by depressing the On/O switch on the Control Unit to the OFF
position. Call 1-800-521-6664 prior to using again.
INSTRUCTIONS FOR USE

12
APPLYING THE CALF TREATMENT PAD (CONTINUED)
Note: Be sure not to over tighten either
the Calf or the Foot straps as this
will cause discomfort and decrease
circulation to your calf and foot.
INSTRUCTIONS FOR USE
Step 2b: Hold the
short side of the top
attachment strap
against your shin. Wrap
the longer side of the
top attachment strap
around your leg and
over the short side of the
attachment strap and
press the Velcro end to
hold in place. Follow the
same procedure with
the bottom attachment
strap. The attachment
straps should only be
tight enough to hold the
treatment pad-do not
overtighten.

13
APPLYING THE FOOT TREATMENT PAD
STEP 3:
First, fasten the front
attachment straps of the Sandal so you
can easily slide your foot in and out of
the Sandal. Next, slide your bare forefoot
(do not wear socks or stockings) into
the sandal. If needed, adjust the strap
to hold your foot in place. The back of
your heel should be positioned at the
rounded side of the Foot Treatment Pad.
Your Freedom 300 should now look
like this on your calf and foot, and you
are ready to begin treatment.
INSTRUCTIONS FOR USE
STEP 4: Start your treatment session
Step 4a: (Starting your session): Turn the On/O switch to the
On position - the Indicator Light will turn green.
Step 4b: Sit on a chair or couch with your feet on the oor for
30 minutes, until your treatment is completed.

14
STEP 5: End Your Treatment Session.
Step 5a: Turn the On/O switch to the O
position.
Step 5b: Remove the Foot Treatment Pad by
sliding your foot out of the Attachment Sandal.
Step 5c: Remove the Calf Treatment Pad by
disengaging the top and bottom attachment
strap and remove from Calf.
Step 5d: Unplug the Power Supply from the wall outlet and
store your Freedom 300 in a safe, dry and cool place away from
children and pets until the next use.
INSTRUCTIONS FOR USE
When putting on or taking o the Freedom 300:
• Do not wrap the cords of the Freedom 300 around
your foot and calf pad
• Make sure the cords and treatment straps are not
tangled or caught in or under furniture
• Never step on or pull on the short cords that
connect the foot treatment pad to the calf
treatment pad.
• Never walk while the Freedom 300 is connected to
your body.
Determine your choice of treatment time and frequency
• Treatment Time/Frequency: (1) 30 minute treatment, daily or
every other day on the symptomatic legs/feet. The system will
automatically shut o after the 30 minute treatment.
NOTE: Depending on symptom severity - patients may use the
system up to (4) 30 minute sessions per foot/leg per day. Separate
treatment sessions on the same leg/foot by 3-4 hours.

15
CLEANING THE ATTACHMENT STRAPS
1. Cleaning is necessary only if the Attachment Straps become
excessively soiled.
2. Unplug the Freedom 300 from the electric outlet.
3. Remove the Attachment Straps from the Treatment Pads by
placing one hand on the Strap near the Velcro and gently
pulling the Treatment Pad away from the strap. Note the
positioning of the Attachment Straps to the Treatment Pads
so you can correctly re-attach them after cleaning.
4. Hand wash the Attachment Straps in cold water and air dry.
5. Re-attach the Attachment Straps to the Treatment Pads
by pressing the Velcro on the Attachment Straps to the
Treatment Pads.
CLEANING THE FOOT OR CALF TREATMENT
PADS
1. Cleaning is necessary only if the Treatment Pads become
excessively soiled.
2. Unplug the Freedom 300 from the electric outlet.
3. Wipe clean using a damp cloth moistured with mild
detergent and water solution. Do not saturate or use bleach.
Warning: Do not saturate or soak the Treatment Pads in a
cleaning or disinfection solution. This may cause corrosion to the
Treatment Pads, which may increase the risk of burns.
!
CLEANING INSTRUCTIONS

16
No special maintenance procedures are required, however, proper
care of the Freedom 300 using the following guidelines will extend
the useful life of this product.
1. Be careful not to drop your Control Unit on a hard
surface, step on it or drop a heavy object on it - as this could
damage the circuitry.
2. Do not remove the system Power Supply from an electrical
outlet by pulling the cords.
3. Do not wrap cords around the Foot or Calf Treatment Pads,
Control unit or Power Supply. This may cause the electrical
cords to fray.
5. Do not pull the Foot Treatment Pad, Calf Treatment
Pad along the oor by the cords. This may damage system
components and or cause the electrical cords to fray.
6. When your therapy session is complete, always turn your
system o using the On/O Switch on the Control Unit and
unplug the Power Supply from the electric outlet.
7. Do not take the Foot or Calf Treatment Pads, or Power Supply
apart or remove any of the cords from their attachment to other
components. Doing so may damage the system components,
prevent the Freedom 300 from working properly and void
product warranty.
When not in use, store your Freedom 300 in a cool, dry area away
from access by either children or pets. Storage in a wet or excessively
damp location may cause corrosion of electrical components
or wiring that may result in electrical shock or impair the proper
function of the device.
Otherwise, no special requirements exist for the transport and
storage of the device. The device is shipped in a poly bag as a
precaution from water damage, but this is not a requirement to
transport the device.
MAINTENANCE
STORAGE

17
Problem Troubleshooting
Green light does
not turn on when
you press the
ON button of the
Control Unit
• Make sure that the Power Supply is
securely plugged into an electric outlet
If the green light is not working, try
another outlet.
• Remove any extension cords in use,
and plug the system directly into the
electrical outlet of the wall.
• Discontinue system use and call
Anodyne Therapy, LLC at 1-800-521-
6664 to arrange for service.
Green light comes
on at the start of
treatment, but
does not turn o
after 30 minutes
• Discontinue system use and call
Anodyne Therapy, LLC at 1-800-521-
6664 to arrange for service.
Treatment Pads
pulling apart
from cords
• Discontinue system use and call
Anodyne Therapy, LLC at 1-800-521-
6664 to arrange for service.
To send a unit to Anodyne Therapy, LLC for repair, you must
rst call 1-800-521-6664 and obtain a return authorization
(RA).
The following information must be supplied to Anodyne
Therapy, LLC before an RA number can be issued:
1) User name and address
2) Device serial number
3) A description of the problem with the unit.
TROUBLESHOOTING GUIDE
RETURNING A UNIT FOR REPAIR

18
Anodyne Therapy, LLC (“Manufacturer”) warrants the Anodyne®
Freedom 300 (“The Product”) to the immediate purchaser as
follows:
Limited Warranty
Manufacturer warrants that The Product sold hereunder will be
free from defects in material and workmanship for a period of one
(1) year from the date of purchase with normal use. If the defects
are of such type and nature as to be covered by this warranty,
Manufacturer shall, at its option, either repair or replace the
damaged product at its expense, (minus customer shipment
fees of products to manufacturer). This warranty does not cover
any Products that have been abused, misused, or tampered with in
any way.This warranty does not cover Products damaged in natural
disaster or ood; nor does it cover theft. This limited warranty
is not transferable, and only applies to purchases direct from
Anodyne Therapy LLC, or its authorized distributors.
THIS WARRANTY IS IN LIEU OF OTHER WARRANTIES, INCLUDING
WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR PARTICULAR USE,WHICH ARE HEREBY SPECIFICALLY
DISCLAIMED.
This limited warranty gives you specic legal rights.You may have
other rights, which vary from state to state. To the extent allowed
by applicable law, in no event shall manufacturer be liable for any
incidental, consequential, special, indirect, punitive or exemplary
damages or lost prots from any breach of warranty.
LIMITED WARRANTY

19
Cleaning, 15
Contraindications, 6
Control Unit, 5, 7, 9, 10, 11, 16, 17
Customer Service, 2, 7, 11, 17
Disposal, 7
Pad Placement, 4, 5, 6, 11-13
Pad Pressure, 4, 5, 6, 11-13
Pain Patches and Topical Agents, 4, 6
Returns and Return Policy, 17,18
Single Use, 8
Straps, 9-13, 15
Silver Metal Sensitivity 4, 6
Troubleshooting, 17
Treatment Frequency, 14
Treatment Time, 5, 8,14
Warnings, Precautions, 4, 5, 6-8, 10, 11, 15
Warranty, 18
Wires/Cords, 4, 10-11, 16-17
INDEX

Anodyne® and MIRETM
are registered trademarks of Anodyne Therapy, LLC.
US Patent No. D612,947
© 2022 Anodyne Therapy LLC
All Rights Reserved
Rev O 6/30/2022
Mr-02750
Manufacturer:
Anodyne Therapy, LLC
Address: 301B Mears Blvd
Oldsmar, FL 34677
Tel: [phone]
Fax: [phone]
Website: www.anodynetherapy.com