Richmar TheraSound EVO User manual

OPERATION MANUAL
TheraSound EVO

TABLE OF CONTENTS
Warranty................................................................................................................... 1
Foreward ..................................................................................................................2
Symbols Glossary.................................................................................................2
Ultrasound Indications.......................................................................................3
Contraindications.................................................................................................3
Operating Instructions.......................................................................................4
Cleaning ...................................................................................................................5
Device Description ..............................................................................................6
Troubleshooting....................................................................................................7
Technical Specifications....................................................................................8
Appendix A.............................................................................................................9

WARRANTY
Congratulations on the purchase of your
Richmar TheraSound EVO.
Richmar warrants that your TheraSound
EVO is free of defects in material and
workmanship. This warranty shall remain
in eect for three (3) years* from the
date of the original end user purchase.
If this Product fails to function during
the warranty period due to a defect in
materials or workmanship, Richmar or
the selling dealer will repair or replace the
respective Product without charge.
All product repairs must be performed by
Richmar.
Any modifications or repairs performed by
unauthorized centers or groups will void
this warranty.
To qualify for warranty coverage, your
product must be registered with Richmar
within ten (10) days of purchase in one of
the following ways:
- Using the online form at
richmarweb.com/warranty-registration
- Mailing in the completed warranty card
included with the device
RICHMAR SHALL RESERVE THE RIGHT
TO REQUEST PROOF OF PURCHASE
FROM THE END-USER TO VALIDATE
THE WARRANTY PERIOD
This warranty does not cover:
1. Replacement parts or labor
furnished by anyone other than
Richmar, the selling dealer, or a
certified service technician.
2. Defects or damage caused by
labor furnished by someone other
than Richmar, the selling dealer,
or a certified service technician.
3. Any malfunction in the Product
caused by product misuse, including,
but not limited to, the failure to
provide reasonable and required
maintenance or any use that is
inconsistent with the Product’s Manual.
RICHMAR SHALL NOT BE LIABLE IN
ANY EVENT FOR INCIDENTAL OR
CONSEQUENTIAL DAMAGES
Some locations do not allow the exclusion
or limitation of incidental or consequential
damages, so the above limitation or
exclusion may not apply to you.
To obtain Service from Richmar or the
selling dealer under this warranty:
1. A claim must be made within
the warranty period to Richmar
or the selling dealer.
2. Please contact Richmar's Technical
Service Department at:
Phone: [phone]
Email: technicalsupport@
richmarweb.com
This warranty gives you specific legal
rights and you may also have other rights
which vary from location to location.
Richmar does not authorize any person
or representative to create for it any other
obligation or liability in connection with
the sale of the Product.
Any representative or agreement not
contained in the warranty shall be void
and of no eect.
THE FOREGOING WARRANTY IS IN
LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING
ANY WARRANTY OR MERCHANT ABILITY
OR FINES FOR A PARTICULAR PURPOSE.
Information in this document is subject to
change without notice. The manufacturer
of the equipment may have patents, patent
applications, trademarks, or copyrights covering
material in this document. This document does
not grant license to any of these intellectual
property rights. The manufacturer shall not
be liable for any errors and/or omissions
for incidental or consequential damages in
connection with the performance, or use
of this material. All rights reserved. Without
limiting the rights under copyright law, no
part of this document may be reproduced,
stored in or introduced into a retrieval system,
or transmitted in any way without the express
written permission of the manufacturer.
*Applicators and any related accessories have a one year warranty.
1

This manual is written to ensure the proper
and safe operation of the TheraSound EVO.
It contains general information regarding
replacement parts, operation, safety
precautions and maintenance. In order to
maximize safety, eciency and the life of
your TheraSound EVO, please read this
manual thoroughly and follow all instructions
prior to operating the unit.
Specifications and instructions put forth
in this manual are in eect at the time of
publication; however, due to Richmar's
policy of continued product improvement,
changes may be made to these
specifications and instructions at any time
without obligation on the part of Richmar.
2
FOREWARD
SYMBOLS GLOSSARY
Declaration of Conformity:
Richmar declares that the
TheraSound EVO complies with
following normative documents:
IEC60601-1, IEC60601-2-22, IEC60825-1
PRECAUTIONARY INSTRUCTIONS
The precautionary instructions found
in this section and throughout this
manual are indicated by specific
symbols. Understanding these symbols
and their definitions before operating
this equipment. The definition of these
symbols are as follows:
DANGER
Possible safety issues that could be
imminently hazardous and could result in
death or serious injury.
WARNING
Possible safety issues that could cause
serious injury and/or equipment damage.
CAUTION
Possible safety issue that could have the
potential to cause minor to moderate
injury or damage to equipment.

ULTRASOUND INDICATIONS
CONTRAINDICATIONS
THERAPEUTIC ULTRASOUND
Richmar Ultrasound devices are indicated to
produce therapeutic deep heat for the following
conditions:
1. Relief of pain.
2. Muscle spasms.
3. Joint contractures.
WARNING
Federal law restricts this device to sale by
or on the order of a physician or any other
practitioner licensed by the law of the state in
which said person practices.
Ultrasound should not be used in the
following areas:
1. Near or over the heart.
2. Near or over the eyes.
3. On the head.
4. Near or over reproductive organs.
5. On the lower back during pregnancy
or over the pregnant uterus.
6. Directly over the spinal column.
7. Where the skin suers from
any sensory impairment.
8. Over areas of malignancies.
9. In the area of visceral plexus and
large autonomous ganglion.
10. Over the thoracic area if the patient
is using a cardiac pacemaker.
11. Over a healing fracture.
12. Over ischemic tissues in individuals
with vascular disease where the blood
supply would be unable to follow
the increase in metabolic demand
and tissue necrosis might result.
PRECAUTIONS
Precautions should be taken when used:
1. Over anesthetized areas.
2. On patients with
hemorrhagic diasthesis.
3. Ultrasound treatment should not be
performed over an area of the spinal
cord following laminectomy (i.e.-
when major covering tissues
have been removed).
WARNING
1. Excessive doses of ultrasound may
cause damage to tissue. Periosteal
pain is an indication of excess intensity
and if it occurs, the power should be
reduced; the transducer should be
moved more rapidly over the
area being treated; or a lower
pulsed duty cycle should be used.
2. If the soundhead has been operated
unloaded for an extended period of
time, the transducer will get hot. If
the soundhead is applied to the
patient while the transducer
is hot, a burn may result.
WARNING
DO NOT operate the soundhead in an unloaded
condition. It is possible that unrepairable
damage may occur to the transducer in an
unloaded state.
3

4
OPERATING INSTRUCTIONS
INITIALIZATION
To operate the device, make sure that the
power cord is plugged into the power
receptacle on the back of the unit. The
power receptacle is located on the rear of
the device, next to the On/O switch. Turn
the switch to the "I," or On position. The
device should then activate.
NOTE: Ensure that an Ultrasound Applicator
is connected into the back of the device. If
NO Applicator is installed, the LCD displays
will illuminate "88" and the unit will not
respond to any user key inputs.
The TheraSound will then go through a
quick diagnostic check where some letters
and numbers appear on the display. This
is normal. After the diagnostic check blue
digits will appear in the time and intensity
windows.
TREATMENT SETUP
To set up a treatment, select the parameters
desired by pressing their corresponding
buttons. A beep will sound every time a
button is pressed on the device.
• Select the duty cycle (100 %, 50 %,
20 %, or 10 %) by pressing the Duty
Cycle Select button.
• Then select the desired treatment time
by pressing the or buttons in the
"Time" area.
• Set the intensity by using the or
buttons in the "Intensity" area.
• With all parameters set, apply coupling
agent to the treatment area. Place
transducer onto the treatment area.
NOTE: Treatment Intensity can be toggled
between W/cm2and Watts by pressing the
Select button to the right of the Intensity
adjustment buttons.
• Press the button and the "Time"
indicator will start to flash. This indicates
that the treatment is running and time
is counting down. Notice that the
"Ultrasound Active" indicator is now
illuminated indicating that the unit is
now delivering ultrasound output.
PAUSING TREATMENT
NOTE: Any treatment parameter may be
modified or changed while the device is
operating simply by pressing the button
corresponding to the parameter to be
changed.
• To pause treatment, press the button.
Time will stop flashing and the intensity
will begin to flash. Notice that the
"Ultrasound Active" indicator light is
no longer illuminated, indicating that
the treatment has been paused and the
unit is no longer delivering ultrasound
output wave forms.
• To resume treatment, press the
button and the time will flash and the
"Ultrasound Active" indicator will once
again illuminate.
• When the treatment time ends, a loud
beep will sound and time will stop
flashing and revert to the last treatment
time entered. The intensity will revert to
zero and the ultrasound active light will
extinguish.
• To stop a treatment, press the button.
Time will stop flashing and revert to the
last treatment time entered. Intensity
will revert to zero and the "Ultrasound
Active" light will extinguish.
NOTE: Recently used parameters, with the
exception of the output intensity, will remain
saved as the default parameters after a
treatment ends. To use the same treatment
again, enter the desired intensity and press
the button to begin.

OPERATING INSTRUCTIONS
CLEANING
5
COMBINATION TREATMENT
Richmar's TheraSound EVO ultrasound is
designed to be connected to any Richmar
clinical muscle stimulator (i.e. Winner EVO
ST4), thus enabling the user to provide
combination therapy to patients.
To connect the TheraSound unit to a
stimulator, simply plug an electrode lead
from the stimulator into the Combo Input
on the rear of the TheraSound, to the left of
the applicator port. The electrode connected
to the channel's other output, along with the
soundhead of the TheraSound, will complete
the circuit to provide stimulation.
CAUTION
When using a combination treatment, note
that both faces of the "Therapy Hammer"
transducer will output stimulation.
Please DO NOT touch the metal portion of
the Therapy Hammer not in use, while
doing therapy, as it could cause potential
shock or harm.
DISINFECTING RECOMMENDATIONS
To disinfect the soundhead between therapy
treatments, Richmar recommends using a
disinfectant cleaner for ultrasound. OSHA
addresses the need for prudent infection
control (OSHA Instruction CPL 2-2.33C)
to include decontamination of equipment
between patients.

THERASOUND EVO, FRONT THERASOUND EVO, REAR
USER INTERFACE
1. Ultrasound Intensity Select
2. Ultrasound Frequency Select
3. Start/Stop
4. Applicator Select
5. Duty Cycle Select
6. Treatment Time Select
7. Pause Treatment
8. Intensity Measurement Toggle
9. On/O Switch
CONNECTION PORTS
10. Electrical Power Entry Module
11. Ultrasound Applicator Port
12. Combo Input
6
DEVICE DESCRIPTION
1
6
5
4
3
7
8
9
11
12
EVO ULTRASOUND
APPLICATOR OPTIONS
1. 5 cm2Applicator
The 5 cm2Applicator is a dual-
frequency (1 MHz and 3 MHz)
ultrasound applicator with an
output range from 0-10 watts
2. 10 cm2Applicator
The 10 cm2 Applicator operates at
1 MHz only with an output range
from 0-20 watts or 0-2.0w/cm2.
3. Hammer Applicator (5 cm2& 2 cm2)
The Hammer Applicator is a dual-
frequency (1 MHz and 3 MHz)
ultrasound applicator. The 5 cm2
transducer provides an output
range from 0-10 watts and the
2 cm2transducer will provide and
output range of 0-4 watts.
4. Autosound Applicator
The Autosound Applicator is a
dual-frequency (1 MHz and 3 MHz)
"Hands Free" style applicator. At 1
MHz output selected, the Autosound
applicator will deliver 0-7 watts; at 3
MHz output, the Autosound Applicator
will deliver 0-5 watts of power.
1
2
3
4
2
10

7
TROUBLESHOOTING
THERASOUND EVO
PROBLEM POSSIBLE SOLUTION
Device fails to
power ON.
Check to verify that the power cord is fully plugged into the
power entry module below the AC switch on the rear of the
device.
Verify that the power cord is plugged into the AC wall outlet
Check the fuse to verify that it has not blown.
CAUTION
To ensure personal safety, unplug the unit before
checking the fuse
Ultrasonic Active LED
fails to Illuminate
Verify applicator cord is firmly connected into applicator
connection port on rear of the device.
Display reads "HEAD"
The "HEAD" warning
is a safety feature
wherein the soundhead
temperature shuts o
to avoid overheating.
This warning occurs
when the soundhead
overheats, usually due
to an un-coupled or
poor coupling situation.
Turn the device o for 3-4 minutes to allow it to reset and turn
it back on again and begin treatment. If the "HEAD" warning is
still displayed, please call the factory
When using the Hammer Applicator, check that the soundhead
in use is selected for output. Be sure to use an adequate
amount of coupling gel or lotion specifically designed for
ultrasound treatment.
OUTPUT TROUBLESHOOTING
Richmar suggests that ultrasound output be
tested once a week. To do this, turn on the
device and start a treatment at
100 % output. The outputting head should
be facing up towards the user. Pour some
water on the soundhead and increase
the intensity. If the device is outputting
ultrasound, the water should cavitate, or
bubble, on the soundhead.
CAUTION
DO NOT operate the ultrasound in an
"unloaded" condition for more than one
minute at intensities greater than
1.0 W/cm2. It is possible that the transducer
may overheat and damage the unit.
ULTRASOUND SERVICE INFORMATION
Richmar recommends that all Richmar
ultrasound therapy products be returned
to the factory or to a Richmar Authorized
Service Center for service or calibration. It is
recommended that the device be calibrated
annually or when any major component has
been changed.

TECHNICAL SPECIFICATIONS
THERASOUND EVO SPECIFICATIONS
Dimensions 9.5"W x 12"D x 6.25"H
Weight 5.6 lbs
Power Input 115 VAC at 1.0 Amp / 230 VAC at 0.5 Amp at 50/60 Hz.
ULTRASOUND APPLICATOR SPECIFICATIONS
5 CM APPLICATOR
Soundhead ERA 5 cm2
Frequency 1 MHz & 3 MHz
BNR 5.5:1 maximum
Output 0-2 w/cm2(0-10 watts +/- 15 %
10 CM APPLICATOR
Soundhead ERA 10 cm2
Frequency 1 MHz
BNR 5.5:1 maximum
Output 0-2 w/cm2(0-20 watts +/- 0 %/-25 %
HAMMER APPLICATOR
Soundhead ERA 2 cm2& 5 cm2
Frequency 1 MHz & 3 MHz
BNR 5.5:1 maximum
Outputs 2 cm2=0-2.0w/cm2(0-4 watts +/- 15 %)
5 cm2=0-2.0w/cm2(0-4 watts +/- 15 %)
HAMMER APPLICATOR
Soundhead ERA 3.5 cm2- treatment area of 14 cm2
Frequency 1 MHz, 3 MHz, or 1 & 3 MHz chain
BNR 5.5:1 maximum
Ultrasound Output 0-2.0 w/cm2
8
NOTE: Autosound 3 MHz and 1 & 3 MHz chain are limited to 1.5 W/cm2

APPENDIX A
9
APPLICATOR TYPE
The ultrasonic radiation fields produced
by Richmar therapeutic ultrasound
transducers are of the plane wave type
and are essentially cylindrical in shape.
This type of applicator is referred to as a
collimating applicator.
APPLICATOR LABEL
Each Richmar applicator is labeled to
provide the user with information on its
applicable parameters. The following
abbreviations are used on the label.
GEN: The Richmar ultrasonic generator
for which the applicator is intended.
F: The operating frequency in MHz for
the applicator.
AREA: The eective radiating area of the
applicator in square centimeters.
BNR: The Beam Nonuniformity Ratio.
TYPE: Coll-means collimating applicator.
NEAR FIELD/ FAR FIELD
If measurements are made of the sound
intensity along the central axis of the
beam produced by the applicator, the
intensity distribution shows maxima and
minima near the applicator and then a
gradual decline beyond the last maximum
intensity.
The “interference” or “near field” is the
area in the ultrasound beam extending
from the applicator surface to the location
of the most distant intensity maximum.
In this area, maxima and minima of
intensity are located close to each other.
This is the area in which most therapeutic
application occurs. This is shown in the
following figure measured 0.5 cm from the
transducer face.
NEAR FIELD DISTRIBUTION
Beyond this point, the beam has a
more uniform intensity and is called the
“far field”. Below is shown the far field
distribution at 16 cm from the transducer
face.
FAR FIELD DISTRIBUTION
The preceding descriptions apply for
radiation emitted into the equivalent of
an infinite medium of distilled, degassed
water at 86 °F (30 °C) and with line
voltage variations in the range of +/-10 %
of the rated value.
NEAR FIELD DISTRIBUTION
FAR FIELD DISTRIBUTION

TRANSDUCER PARAMETERS
AND TOLERANCES
Therapy Hammer EVO Ultrasound
Applicator (2 cm2/ 5 cm2)
Therapy Hammer ultrasound applicators
have both a 2 cm2and 5 cm2transducer.
The Eective Radiating Area (ERA) for
both of these transducers is +/- 25 % with
a Beam Non-uniformity Ratio (BNR) of
5.5:1 or less. Both transducers can operate
with frequencies of 1 MHz or 3 MHz
+/- 10 %.
5 cm2EVO Ultrasound Applicator
The ERA if the 5 cm2EVO Ultrasound
Applicator is +/- 25 % with a BNR of 5.5:1
or less. This applicator can operate with
frequencies of 1 MHz or 3 MHz +/- 10 %.
10 cm2EVO Ultrasound Applicator
The ERA tolerance of the 10 cm2EVO
Ultrasound Applicator is + 0 / - 25 % with
a BNR of 5.5:1 or less. This applicator can
operate with a frequency of 1 MHz
+/- 10 %.
AutoSound EVO Ultrasound Applicator
The AutoSound EVO Ultrasound
Applicator uses four 3.5 cm2transducers
that fire in sequence for 1 second each,
starting with the transducer furthest
from the cord. Each of these transducers
operate with an ERA tolerance of +/- 25 %
and a BNR of 5.5:1 or less. This applicator
can operate with frequencies of 1 MHz, 3
MHz, or a 1 MHz – 3 MHz Sweep within a
tolerance of +/- 10 %.
100 % Mode
When operated in the 100 % mode, the
generator produces a non-interrupted
sinusoidal waveform of one or three MHz.
The peak power and average power are
therefore the same. The error in indication
of radiated power in intensity for the
continuous mode does not exceed +/-
14 % allowing for a 6 % error in the
wattmeter, which equals +/- 20 %.
Pulsed Mode
When operated in the pulsed mode, the
generator produces a square-wave burst
of sinusoidal waveform of 1 MHz or 3 MHz
of 2.5 milliseconds in duration. Depending
upon the Richmar model of therapeutic
ultrasound in use, the duty cycle can
be chosen between 5 % and 95 % duty.
This then implies the repetition rate is
selectable between 20 and 380 pulses
per second. (This is computed by taking
the inverse of the duty cycle 1/380 = .95,
1/20 = .05). The tolerance for the pulsed
mode is +/- 20 %. See the following chart
for second comparison on % Duty cycle to
pulses.
DUTY CYCLE TO PULSES
% DUTY CYCLE PULSES/SECOND
5 20
10 40
15 60
20 80
25 100
30 120
35 140
40 160
45 180
50 200
55 220
60 240
65 260
70 280
75 300
80 320
85 340
90 360
95 380
The error in indication of radiated power
in intensity for an allowable 6 % error in
the wattmeter, which for the pulsed mode
does not exceed +/-14 % allowing equals
+/-20 %.
Timer Accuracy
The Food and Drug Administration
requires that the treatment timer accuracy
is to within 0.5 minutes for the preset
duration of emission for settings less than
five minutes, to within 10 % of the preset
duration of emission for settings from five
to ten minutes, and to within one minute
of the preset duration of emission for
settings greater than ten minutes.
APPENDIX A
10

APPENDIX A
11
RATIO OF TEMPORAL PEAK TO
TEMPORAL AVERAGE (RTPA)
The ratios of temporal peak to temporal
average intensities (Rtpa) will vary with the
pulse rate of the device. Depending upon the
Richmar model of therapeutic ultrasound
in use, the duty cycle can be chosen between
5 % and 95 % duty. The Rtpa is calculated in the
following manner:
Rtpa = (1/Duty):1
Example 5 % duty = .05 (min. duty, max. Rtpa)
Rtpa = (1/.05):1
Rtpa = 20:1
Example 95 % duty = .95 (max. pulsed duty,
min. Rtpa)
Rtpa = (1/.95):1
Rtpa = 1.05:1
See the following chart for % Duty Cycle to
Rtpa comparison.
DUTY CYCLE TO PULSES
% DUTY CYCLE RTPA
5 20:1
10 10:1
15 8.33:1
20 5:1
25 4:1
30 3.33:1
35 2.86:1
40 2.5:1
45 2.22:1
50 2:1
55 1.82:1
60 1.66:1
65 1.54:1
70 1.43:1
75 1.33:1
80 1.25:1
85 1.18:1
90 1.11:1
95 1.05:1
The Rtpa tolerance does not exceed +/-
20 %. The temporal maximum intensity
for each duty cycle as well as the 100 %
modulation is whatever is indicated on the
meter.
The temporal average intensity for each
duty cycle will be the meter indication
multiplied by the percentage duty cycle.
Temporal Average = (Duty) x (Meter
Indication) Example, 5 Watts, 35 % Duty
Temporal Average = .35 x 5 Watts = 1.75
Watts
The Spatial Average Intensities for each
of these setting will be divided by the
transducer’s Eective Radiating Area
(ERA)
Spatial Average = (Temporal Average)/
(ERA) Example, 5 Watts, 35 % Duty, 5 cm2
Transducer
Spatial Average = (1.75 Watts)/(5 cm2) =
0.35 Watts/cm2
The pulse width (On time) of all Richmar
therapeutic ultrasound devices is 2.5
milliseconds (mS). The time between
pulses (O time) in milliseconds is
calculated as follows:
Pulse width (On time) = 2.5mS
O time = [2.5-2.5(%Duty cycle)]/(%Duty
cycle) Where %Duty cycle is represented
as a decimal.
Please see the following example for
computing the O time for a 10 % Duty
cycle:
O time=[2.5-2.5(0.10)]/(0.10)=22.5
milliseconds.
ADDITIONAL TECHNICAL NOTES
The peak power is the same in the pulsed
modes as in the 100 % modulated mode.
Unless otherwise stated, all technical
parameters are accurate within +/-
20 %. When in the pulse modes the unit is
still generating therapeutic heat, although
it is an amount reduced by a factor directly
related to the duty cycle. The pulse rates
are used to allow the practitioner to
treat areas of bony prominences without
creating periosteal pain. The line leakage
is tested in both the forward and reverse
polarities to be less than 50 microamperes
exceeding all standards for medical
devices in this class.

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3255.19.05.A ©2019 Compass Health Brands Corp.
Manufactured for
Compass Health Brands Corp.
Toll Free 1.888.549.4945
6753 Engle Road
Middleburg Heights, OH 44130
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