Richmar SoundCare Plus User manual

INSTRUCTION MANUAL
SoundCare™Plus

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This manual is valid for the
SOUNDCARE™ Plus
This user manual is published by Richmar.
Richmar does not guarantee its contents and reserves the
right to improve and amend it at any time without prior
notice. Amendments may however be published in new
editions of this manual.
All Right Reserved. Rev. V2 © 2019
United States Federal Law restricts this device to sale by or
on the order of a physician or licensed practitioner
Conformity to safety standards
Richmar declares that the device complies with following
normative documents:
IEC60601-1, IEC60601-1-2, IEC60601-2- 10, IEC60601-1-4,
ISO10993-5, ISO10993-10, ISO10993-1
Complies with MDD 93/42/EEC and Amended by directive
2007/47/EC requirements

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TABLE OF CONTENTS
1. GENERAL INFORMATION _______________________________4
1.1 General Description
1.2 Indication For Use
2. SAFETY INFORMATION _________________________________ 5
2.1 Contraindications
2.2 Warnings, Cautions, Adverse Reactions
3. PRESENTATION _______________________________________9
3.1 Panel for Front view
3.2 Liquid Crystal Display
3.3 Treatment Head
3.4 Symbol Definitions
3.5 Key Function
4. INSTALLATION _______________________________________12
4.1 Reception of Equipment and Accessories
4.2 Connection
4.3 Switching On
4.4 Connecting the Sound Head
5. OPERATION INSTRUCTIONS _____________________________13
5.1 Therapy System Set Up
5.2 Start Treatment
5.3 Ultrasound Intensity
5.4 Check Patient Before Treatment
5.5 During the Treatment
5.6 After the Treatment
5.7 Pause
5.8 Emergency Stop
5.9 The Treatment Head
5.10 The Contact Medium
5.11 Disconnecting from the Wall Socket Power Supply
6. MAINTENANCE _______________________________________19
6.1 Cleaning Device
6.2 Cleaning Treatment Heads
6.3 Maintenance
7. DIAGNOSTICS ________________________________________20
7.1 Displays Fail to Light Up
7.2 Error
7.3 The Contact Control Fails to Operate
8 SPECIFICATIONS ______________________________________21
8.1 Technical Specifications
8.2 Program List Table
9. SKIN CARE TIPS ______________________________________23
10. STORAGE ___________________________________________23
11. DISPOSAL ___________________________________________23
12. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES ________24
13. GLOSSARY OF SYMBOLS ______________________________27
14. WARRANTY _________________________________________28

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1.1 General Description
This manual has been written for the SoundCare™ Plus. It contains
general information on the operation, precautionary practices, and
maintenance information. In order to maximize use, efficiency, and the
life of the system, please read this manual thoroughly and become
familiar with the controls, as well as the accessories before operating
the system.
This user manual is published by Compass Health Brands Corp. does
not guarantee its contents and reserves the right to improve and
amend it at any time without prior notice. Amendments will however
be published in a new edition of this manual.
The ultrasound therapy SoundCare™ Plus is an apparatus featuring an
ultrasound therapy unit. Pain aects the quality and enjoyment of life,
especially for those who suer chronic pain. SoundCare™ Plus is
ultrasound therapy device for the treatment of chronic and acute
muscular pain.
1. GENERAL INFORMATION
1.2 Indication For Use
1. Application of therapeutic deep heat can be used for the
treatment of selected sub-chronic medical conditions such as:
Relief of pain, muscle spasms and joint contractures that may be
associated with:
• Adhesive capsulitis
• Bursitis with slight calcification
• Myositis
• Soft tissue injuries
• Shortened tendons due to past injuries and scar tissue
2. Relief of sub-chronic and chronic pain and joint contractures
resulting from:
• Capsular tightness
• Capsular scarring
3. This device should be used in the hospital and home.
4. This device should be operated only by the experienced physician.

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2. SAFETY INFORMATION
Read instruction manual before operating. Be sure to comply with all
“Contraindications”, Warnings”, “Cautions” and “Adverse reactions” in
the manual. Failure to follow instructions may cause harm to user or
device.
2.1 Contraindications
1. This device should not be used for symptomatic local pain relief
unless etiology is established or unless a pain syndrome has been
diagnosed.
2. This device should not be used when cancerous lesions are present
in the treatment area.
3. This device should not be used when open wounds are present in
the treatment area.
4. This device should not be used on patients suspected of carrying
serious infectious disease and or disease where it is advisable, for
general medical purposes, to suppress heat or fevers.
5. This device should not be used over or near bone growth centers
until bone growth is complete.
6. This device should not be used over the thoracic area if the patient
is using a cardiac pacemaker.
7. This device should not be used over a healing fracture.
8. This device should not be used over or applied to the eye.
9. This device should not be used over a pregnant uterus.
10. This device should not be used on 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.
11. This device should not be used over tumors.

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The precautionary instructions found in this section and throughout
this manual are indicated by specific symbols. Understand these
symbols and their definitions before operating this equipment. The
definition of these symbols are as follows.
Caution: Text with a “CAUTION” indicator will explain
possible safety infractions that could have the potential to
cause minor to moderate injury or damage to equipment.
Warning: Text with a “WARNING” indicator will explain
possible safety infractions that will potentially cause serious
injury and equipment damage.
Danger: Text with a “DANGER” indicator will explain possible
safety infractions that are imminently hazardous situations
that would result in death or serious injury.
2.2 Warnings, Cautions and Adverse Reactions
WARNINGS:
1. Care must be taken when operating SoundCare™Plus the
equipment around other equipment. Potential electromagnetic
or other interference could occur to this device or to the other
equipment. Try to minimize this interference by not using other
equipment in conjunction with the SoundCare™ Plus.
2. The device may not be used in close proximity (i.e. less than 2
meters) to short-wave equipment.
3. The device may not be used in so - called “wet rooms” (hydrotherapy rooms)
4. The user must keep the device out of the reach of children.
5. Only use the device for the recommended applications. The device
should be used under medical supervision.
6. Use of controls or adjustment to, or performance of the
SoundCare™ Plus under procedures other than those specified in
the instruction manual may result in hazardous exposure to
ultrasonic energy.
7. Before administering any treatment to a patient you should
become acquainted with the operating procedures for each mode
of treatment available, as well as the indications, contraindications,
warnings, and precautions. Consult other resources for additional
information regarding the application of the Ultrasound.

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8. DO NOT use solvents to clean the device.
9. A damaged device must no longer be used.
10. The device must only be serviced, repaired and opened by
authorized sales center.
11. Dispose of the device in accordance with local regulations. Keep
the operating instructions with the device.
12. Pregnant and nursing women should use the device cautiously.
13. Use the device cautiously when using it on immature bones.
14. For continuous and eective treatment, the device should not be
used more then 30 minutes per day.
15. DO NOT use cellphone while the device is in operation.
16. Use coupling gel for therapeutic ultrasound during treatment.
17. Always keep the sound head in constant motion.
18. The device complies completely with all parts of 21 CFR 1050.
10 of the performance standard for sonic, infrasonic and
ultrasonic radiation-emitting product.
19. Cautions- use of controls or adjustments or performance of
procedures other than those specified herein may result in
hazardous exposure to ultrasonic energy.
CAUTIONS:
1. Keep yourself informed of the contraindications.
2 Read, understand, and practice the warnings, cautions and
operating instructions. Know the limitations and hazards
associated with using any device. Observe the precautionary and
operational decals placed on the unit.
3. DO NOT operate this unit in an environment where other devices
used intentionally radiate electromagnetic energy in an unshielded
manner.
4. DO NOT use sharp objects such as a pencil point or ballpoint pen
to operate the buttons on the control panel.
5. Inspect applicator cables and associated connectors before each use.
6. This device should not be used adjacent to or stacked with other
equipment. If adjacent to or stacked equipment use is necessary,
this device should be observed to verify that it is operating within
the normal configuration in which it is to be used.
7. Portable and mobile RF communications equipment can aect this
device. DO NOT use a mobile phone or other device that emits
electromagnetic fields, near the unit. This may result in incorrect
operation of the device.

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8. This device has been thoroughly tested and inspected to assure
proper performance and operation!
9. Patients with an implanted neurostimulation device must not be
treated with or be in close proximity to any shortwave diathermy,
microwave diathermy, therapeutic ultrasound diathermy, or
laser diathermy anywhere on their body. Energy from diathermy
(shortwave, microwave, ultrasound, and laser) can be transferred
through the implanted neurostimulation system, can cause tissue
damage, and can result in severe injury or death. Injury, damage,
or death can occur during diathermy therapy even if the implanted
neurostimulation system is turned “o.”
ADVERSE REACTIONS:
1. Skin irritation, inflammation, and burns in or around the treatment
area are potential adverse reactions. Please consult a physician if
any of these occur.
2. The clinician should stop using this device and should consult with
the patient’s attending physician should the patient experience any
adverse reactions from treatment used with this device.
Note: Always use devices that are legally marketed and sold in the
United States under 510K guidelines.

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3. PRESENTATION
3.1 Panel for Front View
1. Program Selection Buttons
2. Frequency Adjustment Button (1MHz and 3MHz)
3. Duty cycle adjustment Button
4. Treatment Time Adjustment Button
5. Liquid Crystal Display
6. Stop Button
7. Central Controller Dial
8. Treatment Head Select Button
9. Socket for 5cmSound Head
10. Socket for 1cmSound Head
11. Adapter Receptacle
12. Power Switch
STOP
SoundCare™plus
FREQUENCY
DUTY CYCLE
TIME
5cm
PROGRAM
1cm

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1. Program indicator
2. Frequency indicator
3. Duty cycle indicator
4. Timer indicator
1. Sound head aperture: Makes contact with patient during treatment.
2. Sound head LED Indicator: Indicates if sound head is in working
(steady green light) or non working state.
3. Sound head handle: Connects to the device and where the clinician
holds to administer treatment.
5. Output intensity/power
6. Ultrasound output indicator
7. Pause indicator
8. Working Sound Head Size
3.2 Liquid Crystal Display
3.3 Treatment head

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On/O Switch The Connection Socket of
Treatment Head
Stop Treatment
Start/Pause Button Pause
Ultrasound Intensity Ultrasound Output Power
Ultrasound Applicator State Ultrasound Output Intensity
Polarity of Power Supply Treatment Time
3.4 Symbol Definitions
3.5 Key Function
Below are the definitions for all of the symbols used in the Ultrasound
therapy device. Study and learn these symbols before any operation of
the system.
ON / OFF
Switch
With this button the SoundCare™Plus is
turned on or o.
Central
Controller
Dial
Press to Start/Pause treatment
Rotate this dial to increase or decrease
the output intensity to start/during
treatment
STOP
button
Stop treatment
UP and
DOWN
Arrows
Used t increase or decrease parameters
on the screen for desired treatment
STOP

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4. INSTALLATION
4.1 Reception of Equipment and Accessories
Remove the Therapy System and all accessories from shipping
cartons. Visually inspect for damage. Report any damages to the
company who supplied you the device. Your ultrasound therapy is
supplied with case containing:
No. Part # Part Quantity
1 DQ9275 Ultrasound therapy unit 1
2 DQ9275W5 5cm Ultrasound head 1
3 DQ9275W1 1cm Ultrasound head 1
4 DQ9276MGC Medical Grade Adapter 1
5 SoundCare Plus Manual 1
4.2 Connection
Power supply connections must comply with national requirements for
medical clinics. This equipment has a safety ground connection and
must be connected to another grounded wall socket.
Prior to connecting this device to the wall socket, check that the
voltage and frequency stated on the bottom of the device and in this
manual correspond with the wall socket.
The device adapter and wall socket are a complete socket on which
the device’s safety depends on.
CAUTION:
For safety reasons, if there is a need to replace the adapter, it is
recommended to use only the manufacturer supplied adapter or one
that meets the requirements listed on the bottom of the device and
the requirement standard medical electrical equipment.

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4.3 Switching On
Turn on the device using the power switch. The device executes a self-test,
checking all important functions and enters standby mode about 2~4 seconds
later. When an error is found an error code will appear on the display.
4.4 Connecting the Sound Head
Plug the sound head’s connection plug corresponding to the correct
socket in the back of the device. If connected correctly, LCD will
display as should in Figure 1. If there is a connection error, LCD will
display as shown in figure 2
5. OPERATION INSTRUCTIONS
5.1 Therapy System Set Up
The SoundCare™Plus has 10 default programs available. The programs are
fully adjustable to the capabilities of the device for the parameters below:
• Ultrasonic frequency
• The treatment duty cycle
• Treatment time
If changes are made to a program, they will be saved
automatically and the device will display the last treatment under
that program once the device is turned off and back on again.
Figure 1 Figure 2
CAUTION:
Only use the sound heads supplied with the device. If a replacement
sound is needed, please contact your supplier to get a replacement from
the manufacturer. DO NOT use any other sound heads with this device.

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CAUTION:
When only one sound head is connected, the device will automatically
detect which one is connect and the sound head that is not plugged in
will show as not selectable on the treatment screen.
Select Duty Cycle
Duty Cycle Selection: Press or button next to DUTY CYCLE to
increase or decrease the duty cycle for desired treatment. 100% duty
cycle is continuous. 99% or less is pulsed.
Select the Ultrasound Frequency: 1MHz or 3MHz
Freq Up/Down Selection: Press button next to FREQUENCY to
choose the desired frequency for treatment.
Select Sound Head
Sound head size: Press next to 1cm2and 5cm button to choose
which sound head will be used for the selected parameters. The
selected sound head will display on the LCD as shown below.
Choice / Select Therapy Program
Program Up/Down Selection: Press button to choose between U01-U10

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Select Treatment Time
Treatment Time Selection: Press or button next to TIME to
decrease or increase treatment time for desired treatment time.
5.2 Start Treatment
Place a generous amount of ultrasound gel on the treatment area.
Place the ultrasound head on treatment area and move in slow circular
motions while rotating the central controller dial to clockwise to slowly
increase the intensity to a comfortable level to the patient.
5.3 Ultrasound Intensity
The ultrasound intensity is adjusted with intensity control knob. The
ultrasound intensity can only be adjusted during treatment. The
ultrasound intensity can be displayed in W or W/cm .
5.4 Check Patient Before Treatment
• Put the patient in a comfortable position. The area to be treated
should be properly supported and exposed and perfectly relaxed
• Ensure there are no contraindications to treatment.
• Inspect the skin treatment area for any abrasions, inflammation,
surface veins etc.
• Clean the skin treatment area with soap or alcohol (70%).
• Shaving or clipping excessive hair on the skin treatment area
can provide optimal treatment.
• Test the heat sensitivity of the treatment area.

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5.5 During the Treatment
• The sound head must be moved in slow circular motions,
constantly during treatment.
• Ask the patient regularly about his/her experiences. If necessary,
the treatment can be adjusted. By using the central controller dial,
the output can be reduced or increased to a comfortable level
• In case of indications of poor transmission of ultrasound energy, it
is advised to add the contact-gel or reposition the ultrasound-head.
• If the LED light blinks green or is not producing output, reposition
the sound head and continue to move in a slow circular motion
and/or more ultrasound gel may be needed.
• If the LED light is solid green, there is good contact and the
ultrasonic energy is being emitted.
• If the treatment is paused or the sound head is not connected
properly, there will be no green LED light on the top of the sound head.
CAUTION:
The movement performed with the sound head should be applied with
regular movement, not too slow to avoid inducing heat, nor too fast to prevent
a bad contact which would reduce the eectiveness of the treatment.
WARNING:
If replacing the sound head is necessary, the device must be switch o
before disconnecting and replacing the sound head.
5.6 After the Treatment
• Clean the treatment area well before treatment as well as the
treatment head by using a towel or a tissue.
• The treatment head should be cleaned with a 70% alcohol
solution.
• Check if there are any signs of improvement (e.g. pain,
circulation and mobility).
• When entering the next treatment session, the patient is
instructed to report any possible reaction.

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5.7 Pause
Press the central controller dial to pause the treatment. Press the dial
again to continue the treatment.
5.8 Emergency stop
Press to stop treatment immediately.
5.9 The Treatment head
A treatment head is a precision instrument. Great care is taken in the
development and production in order to obtain the best possible
beam characteristics. Rough treatment (jarring or dropping) can
adversely aect these characteristics, and must therefore be avoided
5.10 The Contact Medium
In order to ensure ecient transfer of energy, a contact medium is
required between the sound head and the body. Air causes virtually
total reflection of the ultrasound energy. The best medium for the
transfer of ultrasound energy is ultrasound/conductive gel.
• Liberally apply ultrasound/conductive gel to the treatment area on
the patient.
• Move the treatment head during therapy session in a circular
motion. The area treated should be two times the diameter of the
treatment head.z
• If the body surface is very irregular, making it dicult to obtain
good contact between the treatment head and the body, or if
direct contact must be avoided (e.g. due to pain), the aected
area may be treated under water (subaqual method). The water
should be degassed (by previous boiling) in order to prevent air
bubbles arising on the treatment head and body.
• Sound head should not be submerged in water further than the
aluminum portion of the sound head. If submerged further, the
sound head is not sealed past this point and will damage the
sound head and render it defective for use. DO NOT let liquid
enter into unsealed areas of the sound head.

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CAUTION:
NEVER apply the gel to the treatment head. The treatment head will
register this as contact and may emit ultrasound energy, which could
damage the treatment head. Always use gel with the requirements for
medical use, such as with CE mark, or are legally marketed in the US.
5.11 Disconnecting from the Wall Socket Power Supply
Switch the button on the side of the device to the OFF position first.
There should not be anything displayed on the LCD screen to indicate
it was turned o. Disconnect the adapter from the wall socket.

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6. MAINTENANCE
6.1 Cleaning the Device
Switch o the device and disconnect it from the mains supply.
The device can be cleaned with a damp cloth. Use lukewarm water
and a non-abrasive liquid household cleaner (no abrasive, no alcohol
content solution). If a more sterile cleaning is needed, use a cloth
moistened with an antimicrobial cleaner.
CAUTION:
DO NOT submerse the device in liquids. Should the device accidentally
become submersed, contact the dealer or Authorized Service center
immediately. DO NOT attempt to use the system that has been
immersed in liquid until inspected and tested by a Service Technician
Certified by an Authorized Service center. DO NOT allow liquids
to enter the ventilation holes in the optional modules. This could
permanently damage the modules.
6.2 Cleaning Treatment Heads
The treatment heads and cables should be regularly inspected for
damage, e.g. hairline cracks, which could allow penetration by liquids.
Clean the contact surface immediately after each treatment. Make
sure that no ultrasound gel remains on the treatment head. We further
recommend cleaning the head and cable daily, using lukewarm water.
The treatment heads can be disinfected using a cloth moistened with
70% alcohol.
6.3 Maintenance
• Maintenance and repairs should only be performed by an
authorized or certified service technician. The manufacturer will
not be held responsible for the results of maintenance or repairs
completed by unauthorized persons.
• The service and or maintenance must be carried out by
conforming to the procedure described in the manual of the device.
• Opening of the device by unauthorized agencies is not
allowed and will terminate any claim to warranty.

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7. DIAGNOSTICS
7.1 Displays Fail to Light up
Check to see if the main adapter is connected to the device and the
main supply.
7.2 Error
The device has discovered a fault
during or after the self-test. The
error displays the following figure 3.
Remove any applicators or cables from
the output sockets and switch the
device o and on again. If the code
re-appears, contact your supplier. The
device is probably defective.
7.3 The Contact Control Fails to Operate
Check the connected plug of ultrasound applicator.
Figure 3
Figure 4