Richmar US PRO 2000 2ND EDITION User manual

INSTRUCTION MANUAL
US PRO 2000 2ND EDITION

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This manual is valid for the
US Pro™ 2000 2nd Edition Portable Ultrasound
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

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TABLE OF CONTENTS
1. GENERAL INFORMATION _______________________________4
1.1 General description
1.2 Medical background
1.3 Foreword
2. IMPORTANT SAFETY INFORMATION ______________________5
2.1 Contraindications
2.2 Warnings and Cautions
3. PRESENTATION _______________________________________8
3.1 Construction
3.2 Features and Benefits
3.3 Steps to Connect the Adapter
4. SPECIFICATION _______________________________________10
5. INSTRUCTIONS FOR USE _______________________________12
5.1 Turn ON Device
5.2 Cancel Warming Feature
5.3 Load Detection System Caution
6. PROGRAM ___________________________________________14
7. MAINTENANCE AND CLEANING _________________________15
8. STORAGE ____________________________________________15
9. TROUBLESHOOTING ___________________________________16
10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES _______17
11. GLOSSARY OF SYMBOLS _______________________________22
12. WARRANTY _________________________________________23

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1. GENERAL INFORMATION
1.1 Device Information
THE US PRO 2000™2ND EDITION is a portable ultrasound device
that generates deep ultrasonic waves within body tissues for the
treatment of selected medical conditions such as pain relief, muscle
spasms, and joint contractures, but not recommended for the
treatment of malignancies. This is an FDA regulated product available
by prescription only.
1.2 Medical Background
EXPLANATION OF PAIN
Pain is a warning system and the body’s method of telling us that
something is wrong. Pain is important; without it abnormal conditions
may go undetected, causing damage or injury to vital parts of our
bodies. Even though pain is a necessary warning signal of trauma or
malfunction in the body, nature may have gone too far in its design.
Aside from its value in diagnosis, long-lasting persistent pain serves no
useful purpose. Pain does not begin until the coded message travels to
the brain where it is decoded, analyzed, and then reacted to. The pain
message travels from the injured area along the small nerves leading
to the spinal cord. Here the message is switched to dierent nerves
that travel up the spinal cord to the brain. The pain message is then
interpreted, referred back and the pain is felt.
1.3 Foreword
This manual contains general information on the operation, precautionary
practices and maintenance information of the DU3035 US Pro™ 2000
2nd edition. In order to maximize the use, eciency and life of the device,
please read the manual thoroughly and become familiar with it before
operating the device. In particular, pay attention to:
1. Information regarding contraindications for using the device.
2. DO NOT use in close proximity (i.e. less than 2 meters) to
shortwave equipment.
3. DO NOT use in “wet rooms” (hydrotherapy rooms).
The manufacturer cannot be held responsible for the results of
using this device for any purposes other than those described in the
operating instructions.

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Safety Symbols Used in this Manual
WARNING
Indicates a potentially hazardous situation which, if not
avoided, could result in serious injury and equipment
damage.
CAUTION
Indicates a potentially hazardous
situation which, if not avoided, may result in minor or
moderate injury to the user or patient or damage to the
device or other property.
2. IMPORTANT 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. DO NOT use over or near bone growth centers until bone growth is
complete.
2. DO NOT use over a healing fracture.
3. DO NOT use over the eyes.
4. DO NOT use on patients with implanted neurostimulation systems
because tissue damage can occur at the location of the implanted
electrodes resulting in sever injury or death. This can also damage
the system components.
5. DO NOT use to treat malignancies, not in the region where
malignant tumors are present.
6. DO NOT use on patients with demand type cardiac pacemakers.
7. DO NOT use on someone who is pregnant.
8. DO NOT use over ischemic tissues in patients with vascular disease
where the blood supply would be unable to follow the increase in
metabolic demand and may result in tissue necrosis (tissue death).
9. DO NOT use over the carotid sinus nerves or arteries, laryngeal or
pharyngeal muscles.

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2.2 Warnings and Cautions
WARNINGS:
1. DO NOT use on patients with hemorrhagic diatheses (excessive
bleeding disorders).
2. DO NOT use over an area of the spinal cord following a
laminectomy, i.e., when major covering tissues have been removed.
3. DO NOT use over areas that are under anesthesia.
4. Avoid bony prominences.
5. When using ultrasound, keep the sound head moving while
maintaining contact with the skin.
6. If treatment becomes uncomfortable, stop treatment and contact
your physician.
7. DO NOT immerse the portable ultrasound in water or other solvent.
8. DO NOT use over metallic implants, especially prostheses with a
cement-matrix.
9. Only use the UL certified AC adapter that is included in the
product case.
10. The device complies completely with all parts of 21 CFR 1050.10
under the performance standard for sonic, infrasonic and ultrasonic
radiation-emitting products.
11. Use of controls or adjustments to performance of procedures
other than those specified herein may result in hazardous exposure
to ultrasonic energy.

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CAUTIONS:
1. Always use this device under the directions of a physician.
2. Patients with the following diseases, symptoms or conditions
should not use the device:
•During pregnancy or menstrual cycle.
•Acute disease, heart disease, tubercle disease, facial
neuralgia (sharp facial pain), pernicious tumor, hemophilia,
high fever, abnormal blood pressure, or under any unhealthy
conditions.
•On patients with sensitive physical conditions, ringworm,
dermatitis, and any infectious disease.
•On persons who are unable to eectively express themselves
such as: infants/small children, mentally disabled individuals,
individuals under the influence of alcoholic beverage, or
during extreme fatigue.
•Production should not be applied on the following areas:
any wounds, the mouth, neuralgia (sharp painful) spots,
surgical areas, sunburned skin, sensitive skin and over skin
implants made of metal, plastic or silicone materials.
•DO NOT use with other electronic equipment, such as ECG
machine etc., even if this device conforms to the EMC
requirement.
3. DO NOT use on the thoracic region if you have a pacemaker.
4. DO NOT use on areas where malignant tumors are present.
5. DO NOT use on the areas of blood inhibited tissue, because there is
not enough blood supplied to the area to meet the metabolic
demand, and this could result in tissue necrosis (tissue death).
6. DO NOT use the device on persons with bleeding issues/disorders.
7. DO NOT use on areas under anesthesia.

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3. PRESENTATION
3.1 Construction
1. Time Indicator Light
2. Time Button
3. Power Indicator Light
4. Intensity Indicator Light
5. Mode Button
6. Power Switch
7. Ultrasound Head
3.2 Features and Benefits
1. All the ultrasound parts are assembled and tested under strict
process controls.
2. To ensure quality, the device has been designed with a single chip
microprocessor.
3. Precious alloy round-headed probe created a smooth surface on
the skin.
4. Produces both pulsed and continuous ultrasound therapy.
5. Single-button control, microcomputer makes the device easy to use.
6. Designed with three output intensities and three treatment time
selections to meet a wide range of therapy requirements.
7. Head warming feature that PRE-HEATS (does not continually
heat during treatment) the sound head prior to starting treatment
for increased patient comfort.
1
3
2
4
6
5
7
8

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3.3 Steps to Connect the Adapter
US PRO™ 2000 2ND EDITION requires the following steps for proper
setup:
1. Ultrasound transmission gel is required when treating a patient
with the US PRO™ 2000 EDITION portable ultrasound device.
2. The AC/DC adapter is required to power the device. No battery is
used.
3. Join the male connector of the AC/DC adapter to the female
connector of the ultrasound unit. Be sure you have a secure fit.
Then plug the AC/DC adapter into a wall outlet to power the unit
The DU3035 US PRO™ 2000 2ND EDITION is now ready for
treatment.
4. Follow the “INSTRUCTIONS FOR USE” section of this manual
WARNING
This device can only be used safely with the original adapter it came
with. DO NOT reassemble or change the adapter to meet other
requirements (including converters or adapters to meet outside US,
countries) Doing so may cause damage to the unit and/or personal
injury and will void the warranty on the device.
This device is not intended to be used in a clinical setting. This device
was developed to be used at home with the guidance and prescription
from a physician for no more than 2-3 times a day at 15 minute
intervals. Be sure to follow all assembly and use instructions.
Wall Outlet
Ultrasound
Unit
AC/DC
Adapte r
Secure
Connectors

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4. SPECIFICATIONS
Item Description
Ultrasound
Probe
Ultrasound Modulation
Frequency
1.0MHz±10%
Max. Output Power 6.4W±20% (Modulation duty cycle at 100%)
Output Power L: 0.32W±20% M:3.20±20% H: 6.40W±20%
Pulse Repetition Rate 100Hz±10%
Modulation Duty Cycle L(5%), M(50%), H (100%)
Eective Radiating Area 4.0cm±20%
Waveform Pulsed
BNR (Max): 5.0
Max. Eective Intensity: 1.6Wcm±20% (Modulation duty cycle at
100%
Eective Intensity: L:0.08W/cm±20% M: 0.80Wcm±20%
H:1.60Wcm±20%
Working Time: Adjustable at 5 minutes, 10 minutes, 15
minutes
Preheat Temperature:
(Pre-treatment warming
only. Does not warm
during treatment)
Max. 35±5 degree centigrade (Note: Actual
preheat temperature will be influenced by
the environmental temperature and preheat
time.)
Preheat Time: Max. 3 minutes
Dimension: 202 mm(L) x 49 mm (W) x 70 mm (H)
Weight: 193g (without adapter)
Material of Applicator: Aluminum Alloy
Beam Type: collimated
Degree of Protection
against Water
IPX7 (Only for Treatment Head)
Power
Adapter
Input: Voltage: AC 100-240V Frequency:
50Hz/60Hz
Output: Voltage: DC 15V, Max. Currency: 1.2A

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Buttons Time: Choose working time: 5m-10m-15m-0m
(stop)
Mode: Choose modulation duty cycle: 5%-50%-
100%
Indication
Lights
Time Indication Lights: 5, 10, 15 minutes
Duty Cycle Indication
Lights
Low (L), Medium (M), High (H)
Operation
Conditions
5°C - 40°C; 30% - 75%RH; 800-1060hPa

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Apply Transmission gel: Wash the area to be
treated so that it is free of oil and dirt. Apply a
generous layer of ultrasound transmission get
on the treatment gel. The gel acts as a coupling
substance and ensures eectiveness and safety.
The area treated should be two times the
diameter of the sound head.
5.1 Turning on the Device and Head Warming Feature
Turn the device on by sliding the power switch
upwards (towards “ON”). The power indicator
light will illuminate. The device will automatically
enter the preheat mode. The six indicator lights
will flash alternately during this period.
When the preset temperature is reached or the maximum preheat
time had ended (3 minutes), all of the indicators lights will flash five
times. Once complete, the device enters standby mode. This head
warming feature takes approximately three minutes from a cold/room
temperature start to finish.
Note: Head warming feature that PRE-HEATS 9does not continually
heat during treatment) the sound head prior to starting treatment for
increased patient comfort.
5.2 How to Cancel the Warming Feature
If the warming feature is not needed, press both the “MODE” button
and the “TIME” button simultaneously. The device will go back to
standby mode. When the device is in standby mode, the modulation
duty cycle is defaulted at 5% and the (L) indicator light will be
illuminated.
WARNING:
During the head warming period, the following items should be noted:
1. The Device will automatically exit the head warming feature if any
load is detected in the preheating process. Therefore, DO NOT apply
the ultrasound head to the patient during the warming period.
2. To restart the warming feature, you will have to power o the
device and turn it back on again.
5. INSTRUCTIONS FOR USE

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Set ultrasound intensity: Press the “MODE”
button to select the modulation duty cycle.
The mode button has three levels, Low
(L) - 5%, Medium (M) - 50%, and High (H) -
100%, each level corresponds to a LED light
indicator.
Set treatment time: Press the “TIME” button
to cycle through the treatment time (5, 10 and
15 minutes), as shown by the “TIME” indicators.
When the time is chosen, the system will
start working. During working time, the user
can press the “TIME” button to adjust the
treatment time.
Place sound head on treatment area and
begin treatment: Move the sound head in a
slow, flat, circular motion over the skin surface
of the treatment area. Apply the sound head
evenly (in time) over the treatment area.
WARNING: If the motion is not consistent
enough or stops, it could cause potential
harm. Keep the ultrasound moving while in
contact with the treatment area.
Turn o the device: After completing
the treatment session, the device will
automatically shut o and all indicator lights
will be o. Power o the device physically by
sliding the power switch downwards (towards
“OFF”). Unplug the unit from its power source.
Clean the device after every use: With
device turned o, clean the ultrasound head
probe with a wet towel or soft tissue. DO
NOT immerse the device in water. Always
store device in its protective case at room
temperature in a dry location.

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6. Program
PROGRAM MODULATION
DUTY FACTOR
WAVE
CHARACTER
OUTPUT POWER
W/cm
L 5% Low 0.08±20%
M 50% Medium 0.8±20%
H 100% High 1.6±20%
5.3 Load Detection System Caution
1. The device has a load detection system for safety. When the
treatment head does not have good contact with the skin, the
device will stop treatment automatically, and the time indicator
light will flash once. The device will not continue the treatment
program until good contact is made.
2. The device has a temperature protection function. When the
temperature of the treating head exceeds 107°F (42°C), the
treatment will automatically stop and the time indicator light will
flash twice. The device will not continue the treatment program
until the temperature is below 104°F (40°C)

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7. MAINTENANCE AND CLEANING
Switch o the device and disconnect it from the power 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
unit accidentally become submersed, contact the dealer or Authorized
Service center immediately. DO NOT attempt to use the device that has
been submersed in any liquid substrate until inspected and tested by a
Service Technician certified by an Authorized Service Center.
Cleaning the Applicator
The applicator should be regularly inspected for damage, e.g. hairline
cracks, which could allow the penetration of liquids. Clean the contact
surface immediately after each treatment. Make sure that no ultrasound
gel remains on the applicator. We further recommend cleaning the
head, cable and adapter daily, using a soft cloth damped with lukewarm
water. The applicator can be disinfected using a cloth moistened with an
antimicrobial cleaner.
8. STORAGE
1. For prolonged pauses in treatment, store the device in a cool dry
room and protect it against heat, sunshine and moisture.
2. Store the device in a cool, well-ventilated place.
3. NEVER place any heavy objects on the device.
4. Storage Conditions: 14°F ~ 122°F, 20% ~93% Relative Humidity

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9. TROUBLESHOOTING
The device is manufactured through complete quality assurance system.
If there are any performance problems, please check the chart below
for problems you can fix. Performance problems often result from little
things that you can find and fix at home without tools. This can save you
the cost of a service call.
For technical documentation or support, please contact your local
distributor or the manufacturer as shown on the label.
PROBLEM CHECK POINTS POSSIBLE
SOLUTION
LED light does not
turn on.
1. The plug adapter is
not inserted into the
socket properly
2. The DC plug of
the adapter is not
inserted into the DC
receptacle on the
device correctly.
3. Did not press on
the ON/OFF button
1. Insert the plug of
the adapter into the
socket again.
2. Connect the
adapter with
the device again
correctly.
3. Press the ON/OFF
button again
LED is performing
normally but no
output function
occurs
Output intensity
button setting is
incorrect
Please make sure
and set it again.

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10. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES
IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC
COMPATIBILITY (EMC)
With the increased number of electronic devices such as PC’s and mobile (cellular)
telephones, medical devices in use may be susceptible to electromagnetic interference
from other devices. Electromagnetic interference may result in incorrect operation of
the medical device and create a potentially unsafe situation.
Medical devices should also not interfere with other devices. In order to regulate the
requirements for EMC (Electro Magnetic compatibility) with the aim to prevent unsafe
product situations, the IEC60601-1-2 standard has been implemented. This standard
defines the levels of immunity to electromagnetic interferences as well as maximum
levels of electromagnetic emissions for medical devices.
Medical devices manufactured by Compass Health Brands Corp. conform to this
IEC50501-1-2:2007 standard for both immunity and emissions. Refer to EMC table
guidance supplied in this manual regarding the EMC environment in which the device
should be used.
Special precautions need to be observed:
1. The use of accessories and cables other than those specified by Compass Health
Brands Corp. may result in increased emission or decreased immunity of the device.
2. Care must be take when operating this device adjacent to or stacked with
other equipment. Potential electromagnetic or other interference by not using
other equipment in conjunction with it.
3. The performance of the device was determined to be essential performance. This
device has been thoroughly tested according to tested and inspected to assure
proper performance and operation.

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Guidance and manufacturer’s declaration - electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below.
The customer or the user assures that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The device 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
CISPR 11
Group B The device is suitable for use in all
establishments including domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/flicker
emissions IEC
61000-3-3
Applicable

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Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
The customer or the user should assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance
level
Electromagnetic
environment guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±6 kV contact ±6 kV contact Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30 %.
±8 kV air ±8 kV air
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply
±2 kV for
power supply
Main power quality should
be that of a commercial or
hospital environment. If
the user of the device
requires continued
operation during power
mains interruptions, it is
needed that the device
be powered from an
uninterruptible power
supply
Surge IEC
61000-4-5
±1 kV line(s) to
line(s)
±1 kV line(s) to
line(s)
Voltage dips,
short interrup-
tions and volt-
age variations
on power supply
input lines IEC
61000-4-11
<5% UT (>95%
dip in UT) for 0.5
cycle
<5% UT (>95%
dip in UT) for
0.5 cycle
40% UT (60%
dip in UT) for 5
Cycles
40% UT (60%
dip in UT) for 5
Cycles
70% UT (30%
dip in UT) for 25
Cycles
70% UT (30%
dip in UT) for
25 Cycles
<5% UT (>95%
dip in UT) for
5 sec
<5% UT (>95%
dip in UT) for
5 sec

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Guidance and manufacturer’s declaration - electromagnetic emissions.
The device is intended for use in the electromagnetic enviroment specified below. The
customer or the user of the device should assure that it is used in such an environment.
Immunity
test
IEC 60501
test level
Compliance
level
Electromagnetic environment guidance
Conduct-
ed
RF lEC
61000-
4-6
3 Vrms
150 kHz
to 80 MHz
3 Vrms Portable and mobile RF Communications
equipment should be used no closer to any
part of the device, including cables, than
the recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance:
Where P is the maximum output power
rating of the transmitter In watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m). Field strengths
from fixed RF transmitters, as determined
by an electromagnetic site survey, a should
be less than the compliance level in each
frequency range b. Interference may occur
in the vicinity of equipment marked with the
following symbol.
Radiated
RF lEC
61000-
4-3
3 V/m 80
MHz to
2.5 GHz
3 V/m
NOTE I. At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation
is aected by absorption and reflection from structures, objects and people.
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and land mobile radios, amateur radio, AM and FM broadcast
and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which
the device is used exceeds the applicable RF compliance level above, should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the device.
2. Over the frequency range 150 kHz to 80 MHz, field strength should be less than
(3i) W/m.
80 MHz
to 800 MHz
800 MHz
to 2.5 MHz