Anodyne Therapy 120 User manual

Important Safety Information
and Instructions
Read Entire Booklet Before Operating
Anodyne®Therapy
Consumer System
Model 120

2
The Anodyne® Therapy System is a noninvasive medical
device that delivers Monochromatic Infrared Energy/
(MIRE™) through infrared light-emitting diodes. These
diodes are mounted in exible Therapy Pads, and emit
infrared light at a wavelength of 890 nm - increasing local
circulation and reducing pain, stiness and muscle spasm
where applied.
Anodyne® Therapy Systems received clearance from the
US FDA in 1994 and are compliant to the ISO 13485 Inter-
national Standard.
Review this manual in its entirety prior to using this system
and contact AnodyneTherapy, LLC at 1-800-521-6664 with
any questions, comments or concerns.

3
Summary .................................................................................................... 4-5
General Warnings and Precautions.................................................... 6-8
Purpose of Device (Indications for Use)............................................... 8
Device and Parts Description................................................................... 9
Environmental Conditions Aecting Use ........................................... 9
Instructions for Use ........................................................................... 10-12
Treatment Guidelines ........................................................................ 13-16
Cleaning ........................................................................................................17
Maintenance ...............................................................................................18
Storage...........................................................................................................18
Troubleshooting.........................................................................................19
Declarations .......................................................................................... 20-21
Warranty and Return Policy................................................................... 22
Index ............................................................................................................. 23
TABLE OF CONTENTS

4
Warning and Cautions
This device emits heat and may cause burns. Risk of burns is
reduced in the following ways:
• Do not use for more than 30 minutes.
• Never use pain patches or topical heating agents before, during,
or after treatment.
• Stop treatment if the Control Unit orTherapy Pads feel too warm.
• Apply the Therapy Pads exactly as described throughout this
manual.
• Warning to decrease the risk of burns, do not over tighten
Attachment Straps, stand or put pressure on Foot Therapy
Pad. Do not treat on the top of the foot or hand and be careful
treating over bony areas.
This is an electrical device. To avoid electrical shock:
• Do not use in water, near water or while wet.
• Do not use if electrical cords are frayed or you can see exposed
wires.
• Do not saturate, soak or immerse components in water or liquid.
• Do not store in a wet or excessively damp location-this may
cause rust or corrosion of electrical components or wiring and
result in electrical shock or impair proper function of device.
!
This summary is not intended to replace the complete user
instructions.The entire manual should be read and understood
before operating the Model 120.
SUMMARY

5
Basic Operating Instructions:
Components: Image of the Model 120 components are shown
on page 9.
Set Up: Place the Control Unit on the oor next to you. Plug
the Therapy Pad cords into the Connectors on the front of the
Control Unit. Plug Power Supply into an electrical outlet. Place the
Therapy Pads over the area to be treated and attach with supplied
attachment straps.
If treating the foot and leg: rst position two Therapy Pads into
the Foot Strap. OneTherapy Pad should be positioned horizontally
across and under the toes, and the second Therapy Pad should be
placed lengthwise and under the arch of the foot. Slide your foot
into the Foot Strap and comfortably tighten to hold the Therapy
Pads lightly in contact with the bottom of your foot. Place two
Therapy Pads (one of each side of your calf) where your pain
or discomfort begins; comfortably hold in place with the Leg
Attachment Strap. (See images on pages 11-12)
Turn on Control unit to begin treatment: Push the On/O Switch
to the On position. The unit is operational if both of the green
Indicator Lights on the Main Control Unit light up.
Treat for no longer than 30 minutes and remove.
Remove pads at the end of treatment: Loosen the attachment
straps and remove theTherapy Pads from the treatment area. If you
are treating the foot and leg, slide your foot out of the Foot Strap
and loosen the Leg Attachment Strap to remove theTherapy Pads.
Turn o the Main Control Unit, unplug from the electric outlet and
store in a safe place away from children and pets.
SUMMARY

6
!
Therapy Pad
Placement
• Never use the Therapy Pads for more than 30
minutes in one area.
• If skin is very dry, thin or sensitive, use for the
minimum times listed in the Instructions for Use.
• Slightly lift your Therapy Pads every 10 minutes
to check for burns. If there is evidence of a burn,
discontinue treatment and call 1-800-521-6664.
• Never sleep during an active treatment session.
• We recommend setting a timer to avoid over
treatment.
Therapy Pad
Pressure
• Do not stand on or put excessive pressure on either
of the Therapy Pads during treatment as this will
increase the risk of burns.
• Use caution when treating over bony areas such as
ankles, knees, elbows, and tops of feet and hands.
These areas have less tissue and are more susceptible
to burns.
Therapy Pad
Warmth
• It is normal to experience warmth during treatment.
However, if any of the Therapy Pads feel too hot for
comfort, discontinue use 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 Therapy Pads over pain patches like
Duragesic®, or residual of; or topical heating agents
like BenGay® or Icy Hot®, as this may increase the
likelihood of a burn.
Other • Do not saturate, soak, or immerse components in
water or liquid.
The Anodyne® Therapy System, Model 120 should not be used
directly over or near the womb during pregnancy or directly over
an active cancer lesion. The use of this device with these types of
conditions are unknown.
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 Model 120 by children
or incapacitated persons may be dangerous.
To minimize the risks of burns, please read
and follow these important precautions:
CONTRAINDICATIONS
GENERAL WARNINGS AND PRECAUTIONS

7
Electrical Precautions
• The device is intended to be connected with a medical grade
power supply plugged into a standard receptacle.
• This equipment is intended for use with Anodyne® Therapy pad
cables only.
• The Anodyne® Therapy System needs to be installed and put into
service according to the information supplied with this instruction
manual.
• Do not modify any portion of this equipment.
• 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.
• Use only the supplied attachment straps, paper tape, gravity or
applicators approved in this manual to maintain the Therapy Pad
position. Do not use pins or other metallic materials as a means
of attachment.
• Like any other electrical device, do not use this system in water,
near water or while wet. Use of this system 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 device.
• The Anodyne®Therapy System, Model 120 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.
!
CAUTION: THIS IS AN ELECTRICAL DEVICE
AND CAN CAUSE ELECTRICAL SHOCK.
Attention, consult accompanying documents
OO (power: disconnection from the mains)
IOn (power: connection to the mains)
Direct current
Alternating current
Dispose at hazardous waste facility
!
________
- - - - - - - -
Markings and Symbols
GENERAL WARNINGS AND PRECAUTIONS

8
PRECAUTIONS
• The Model 120 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/near the treatment area,
cover theTherapy Pads or the treatment area with a clear plastic
barrier to keep this system clean. Discard plastic barrier after
use.
• Do not leave your Model 120 unattended around small children
or pets.This could lead to serious shock, cuts and or infections.
• Discontinue use if device materials cause skin irritation.
PURPOSE OF THE DEVICE (INDICATIONS FOR USE)
• The purpose of the Anodyne® Model 120 is for the temporary
relief of pain, stiness and muscle spasm and for temporarily
increasing blood circulation.
!
GENERAL WARNINGS AND PRECAUTIONS

9
Do not operate in a wet environment as this may
cause electrical shock.
!
The Anodyne® Therapy System, Model 120 consists of the Main
Control Unit, Therapy Pads, Attachment Straps, Velcro Strips, and
an optional Lower Extremity Treatment System. Also included is a
carrying case, which is not pictured.
Velcro
Strips
Attachment
Straps
Main Control Unit
Leg Attachment
Strap
Foot
Strap
Back of Main
Control Unit
On/O
Switch
NORMAL ENVIRONMENTAL CONDITIONS
• An ambient temperature range of +10 degrees C to +40 degrees C
(50° F to 104° F).
• A relative humidity range of 30% to 75%.
• An atmospheric pressure range of 500 hPa to 1060 hPa.
ENVIRONMENTAL CONDITIONS FOR TRANSPORTATION
AND STORAGE
• An ambient temperature range of -40 degrees C to 70 degrees C
(-40° F to 158° F).
• A relative humidity range of 10 to 100RH including condensation. Be
sure not to store in excessively damp location.
• An atmospheric pressure range of 500 hPa to 1060 hPa.
• Device is packaged to maintain cleanliness and minimize egress of water.
Therapy Pads
Indicator Lights
COMPONENTS

10
Step 1: Remove the device 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 user manual before using this device.
Step 3: If you are treating your feet and legs, remove socks or other
hosiery - this will ensure you obtain the best results.
Step 4: Place the Control Unit on the oor or on a table next to
either an easy chair or couch where you will treat yourself. Do
not position the device where it could fall and cause injury. This
device 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.
Step 6: Turn on the Control Unit by depressing
the On/O Switch to the On position. The Green
Indicator Light will turn on (if not, please see
Troubleshooting).
Step 7: The system is now ready for use. Information on pad
placement and treatment times is found in the Instructions for
Use on pages 14 and 15 of this user manual.
Step 8: Ending Your Treatment Session: After your treatment
is completed, turn the On/O switch to the OFF position, unplug
the Power Supply from the wall, and store in a safe, dry and cool
place away from children and pets until the next use.
!
Warning: If electrical wires are exposed, discontinue system use
and call Anodyne Therapy, LLC at 1-800-521-6664 to arrange for
service. Exposed wires may be unsafe and cause electrical shock.
SETTING UP YOUR SYSTEM
INSTRUCTIONS FOR USE

11
Step 2: Slide the front of your foot (do
not wear socks or hosiery) under the front
of the Foot Strap.
Step 3: Comfortably tighten the straps
over your forefoot to hold the Therapy
Pads in direct contact with the bottom of
your foot.
Step 4: Sit comfortably in a chair or couch
with your feet on the oor to make sure
that the Therapy Pads remain in contact
with the bottom of your foot to maximize
treatment results. DO NOT STAND OR
WALK ON THE FOOT STRAP.
Step 5: Turn on your Model 120 by
depressing the ON/OFF switch and begin
your treatment following the times listed
in the Instructions for Use on pages 12
and 13 of this guide.
The Foot Strap is not meant to be
used with multiple patients. Do not
share your Foot Strap with others.
Step 1: Place oneTherapy Pad horizontally
under and across the toes and the second
Therapy Pad lengthwise under the arch of
your foot.
SETTING UP YOUR FOOT STRAP
Never stand or walk in the Foot
Strap as this may increase your
risk for a burn.
INSTRUCTIONS FOR USE

12
SETTING UP YOUR LEG ATTACHMENT STRAP
The Leg Attachment Strap is used to hold
the Therapy Pads on the sides of your calf.
Step 1: Velcro the Therapy Pads to the
Leg Attachment Strap. To ensure eective
treatment, the Therapy Pads should be
placed on each side of the calf, wherever the
pain or discomfort begins (as demonstrated
in the picture to the right). Avoid bony
areas like the shin and ankle. You may need
to adjust the location of the Therapy Pads
on the Leg Attachment Strap to t your leg.
Step 2: Secure the attachment strap around
your leg. Be sure not to apply the strap too
tightly as this will increase your risk for a
burn.
INSTRUCTIONS FOR USE
ENDING YOUR TREATMENT SESSION
Step 1: Turn the on/o switch at the back of
the control unit to the OFF position (green
indicator lights will go o). Unplug the
Power Supply from the wall outlet.
Step 2: Remove the Foot Strap by sliding your foot out of the Foot
Strap.
Step 3: Remove the Leg Attachment Strap by loosening the Velcro
attachment.
Step 4: Store the Anodyne Model 120 in a safe, dry and cool place
away from children and pets until the next use.

13
• Be sure you review all the Warnings and Precautions before
using this system to prevent burns or electrical shocks.
• You may treat an area up to three times per day, separated by
at least four hours between treatments.
• Treated area may be pink after therapy session, and wounds in
or near the treatment area may have increased uid discharge.
• It is normal to experience tingling and pulsing as circulation re-
turns to the leg and foot. If the treatment becomes uncomfort-
able, discontinue use and call 1-800-521-6664 for assistance.
• Ensure that there is nothing (for example: sock, clothing or
bandage) between the Therapy Pads and your skin except for
a clear plastic barrier.
• All of the diodes should be in light, direct contact with the skin.
• This system may be safely used over metal implants, pins and
screws and in people with pacemakers and debrillators.
• It is normal to feel warmth during a therapy session. If any of
the Therapy Pads feel too hot or uncomfortable, discontinue
use and call 1-800-521-6664 for assistance.
Always follow your doctor’s recommendations.
TREATMENT GUIDELINES

14
To temporarily increase circulation, decrease pain or muscle
spams in the extremities
Therapy Pad
Placement
Feet and Legs:
- Place two Therapy Pads in
the form of a “T”inside the
Foot Strap.
- Place one pad on each side
of calf approximately where
symptoms begin using the
Leg Attachment Strap.
Arms and Hands:
- Place one to two Therapy Pads
on the palm of the hand.
- Place one pad on each side of
the forearm or approximately
where symptoms begin.
Do not apply the Therapy Pads
with excessive pressure
Initial
Usage
Frequency
(First 90 days)
Daily for three months or
until condition resolves per a
physician.
Using the system less than
three times per week may
reduce results.
Maintenance
Frequency
(Post 90 days)
1-3 times per week after initial
90-day period.
Treatment
Time 30 minutes
Do not place Therapy
Pads on top of foot or
stand on Foot Strap
Pads should be placed
inside the Foot Strap like
a “T” and placed on each
side of the calf.
TREATMENT GUIDELINES

15
Therapy Pad
Placement
Place a minimum of two Therapy Pads directly over
the painful area (i.e., knee, elbow, neck, back, etc.)
If placement of Therapy Pads causes increased
pain, place pads right next (lateral) to the injured
site.
Do not apply the Therapy Pads
with excessive pressure
Initial Usage
Frequency
Daily if possible.
Minimum of three times per week.
Maintenance
Usage
Frequency
Acute: treatment may be ceased when condition
resolves.
Chronic: as needed for pain relief and increased
circulation
Treatment
Time 30 minutes
Therapy Pads may be easily removed from the Foot Strap for
treatment of another area of the body where needed. For Therapy
Pad placement examples, reference page 16 of this user manual.
To temporarily relieve pain, muscle spasm or stiness
TREATMENT GUIDELINES

16
The Therapy Pads can be arranged to t any area of the body
where the user is experiencing pain or would benet from
increased circulation.
PAD PLACEMENT EXAMPLES
If there is an open
wound in the treatment
area, or if this system is
being shared by more
than one user;
Cover the Therapy Pads
with a clear plastic bar-
rier to avoid the spread
of bacteria, viruses and
other microorganisms
from one person to
another.

17
Attachment Straps:
1. Cleaning is necessary only if the Attachment Straps become
excessively soiled.
2. Remove the Attachment Straps from theTherapy Pads by placing
one hand on the Strap near the Velcro and gently pulling the
Therapy Pad away from the strap. Note the positioning of the
Attachment Straps to the Therapy Pads so you can correctly
re-attach them after cleaning.
3. Hand wash the Attachment Straps in cold water and mild
detergent, rinse and air dry.
4. Re-attach the Attachment Straps to the Therapy Pads by
pressing the Velcro on the Attachment Straps to the Therapy
Pads.
Therapy Pads
1. Cleaning is necessary only if the Therapy Pads become
excessively soiled.
2. Unplug the Model 120 from the electrical outlet.
3. Lightly spray a clean cloth with a common household
disinfectant spray and wipe the cloth over the entire surface
of the Therapy Pads.
Foot Strap
1. Cleaning is necessary only if the Foot Strap becomes
excessively soiled.
2. Remove the Therapy Pads from the Foot Strap.
3. Engage the Velcro straps of the Foot Strap.
4. Hand wash in cold or warm water with a mild detergent, rinse
and air dry.
5. Take care to keep the Velcro areas free from lint.
6. Re-attach the Therapy Pads to the Foot Strap as shown on page
11 of this user manual.
Do not saturate or soak the Therapy Pads in a cleaning or disinfection
solution. This may cause corrosion to the Therapy Pads, which may cause
product failure and increase the risk of burns.
!
CLEANING INSTRUCTIONS

18
No special maintenance procedures are required, however, proper
care of the Model 120 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 - the as this could
damage the internal circuitry.
2. Do not remove the system Power Supply from an electrical
outlet by pulling the cords - but rather by pulling by the
electrical plug.
3. Do not remove the system Power Supply from the back of the
Control Unit, as these components are soldered together.
4. Do not wrap cords around the Therapy Pads, Control unit or
Power Supply. This may cause the Therapy Pads to separate or
cause the cords to fray.
5. Do not carry or pull the system by Therapy Pads or electrical
cords. Doing so may cause components to separate and or fray.
6. When your treatment session is complete, always turn your
system o using the On/O Switch on the back of the Control
Unit and unplug the Power Supply from the electric outlet.
When not in use, store your Model 120 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

19
Problem Troubleshooting
Only one
green light
illuminates on
front of the
Control Unit
• Slightly bend the wire that attaches the
Therapy Pad to the Main Control Unit. Does
this resolve the problem?
• Push and turn the connectors that attach
into the Main Control Unit to make sure
there is a tight connection. Does this resolve
the problem?
• Discontinue system use and call Anodyne
Therapy, LLC at 1-800-521-6664 to
arrange for service.
Green light on
Power Supply
does not
illuminate/no
power
• Make sure that the Power Supply plug is
securely inserted into an electric 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.
Therapy Pads
are damaged
• Wires exposed or Therapy Pad materials are
separating.
• Discontinue system use and call Anodyne
Therapy, LLC at 1-800-521-6664 to
arrange for service.
Control Unit or
Therapy Pads
get too hot
• A therapeutic warmth is normal, however,
this should not cause discomfort.
• Have a friend or family member confirm
heat.
• If problem persists, discontinue system
use and call Anodyne Therapy, LLC at
1-800-521-6664 to arrange for service.
TROUBLESHOOTING GUIDE

20
The Anodyne® Therapy System, Model 120, is intended for use in
the electromagnetic environment specied below. The user of this
product should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment -
Guidance
RF emissions Group 1
The Model 120 uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emissions Class B
The Model 120 is suitable for use in all es-
tablishments including domestic establish-
ments and those directly connected to the
public low-voltage power supply network
that supply buildings used for domestic pur-
poses.
Harmonic
emissions
IEC 61000-3-2
Not
Applicable
Voltage
Fluctuations/
Flicker
emissions
IEC 61000-3-3
Complies
Each Therapy Pad contains 60 - 890nm light emitting diodes (LEDs)
that emit infrared energy at a radiant intensity of 18.4 mW/sr.
Based upon the supplier’s LED specications, the photo biological
emissions from the Anodyne Therapy System Model 120 meet the
eye safety guidelines of the IEC60825-1- Class 1, IEC62471- Exempt,
and the EU Directive 2006/25/EC.
DECLARATION - ELECTROMAGNETIC EMISSIONS
DECLARATION - PHOTO BIOLOGICAL EMISSIONS