IBRAMED SONOPULSE III User manual

Instructions Manual
SONOPULSE III
Therapeutic Ultrasound 1 and 3 MHz
Manufactured by
Ibramed - Indústria Brasileira de Equipamentos Médicos EIREILI.
Made in Brazil
ANVISA Nº 10360310024
3th edition (REV_07/2012)

2
TABLE OF CONTENTS
SYMBOL DEFINITIONS.............................................3
CARTON.......................................................4
ABBREVIATIONSGLOSSARY......................................5
FIGURES GLOSSARY................................................5
FOREWORD...........................................................6
PRODUCT DESCRIPTION..........................................6
ESSENTIAL PERFORMANCE ..............................6
SAFETYPRECAUTIONS.............................................7
INDICATIONS AND PRECAUTIONS.............................9
CONTRA INDICATIONS AND ADVERSE REACTIONS......10
POPULATION AND CONDITIONS OF USE...................11
RESPONSIBILITY FOR USE ELECTROMEDICAL
EQUIPMENT.........................................................12
GENERAL EQUIPMENT CARE....................................13
SHIPPING DAMAGE........................................13
INSTALLATION, CARE AND CLEANING...............13
ELECTROMAGNETICCOMPATIBILITYGUIDANCE.........16
SPECIFICATIONS..................................................24
SYSTEM SPECIFICATIONS...............................24
SPECIFICATIONS OF ULTRASOUND...................25
NOMENCLATURE...................................................26
CONTROLS, INDICATORS AND CONNECTORS.....26
DEFINITION OF SYMBOLS....................................29
ACCESSORIES USED...........................................31
OPERATION INSTRUCTIONS.................................32
PROGRAMMING THE EQUIPMENT..........................36
DIRECTIONS ON ULTRASOUND............................37
PATIENT PREPARATION................................37
TECHNICS OF ULTRASOUND APPLICATION............38
COMBINED THERAPY USING SONOPULSE III.........39
APPLICATION TECNIQUE FOR COMBINED
THERAPY...........................................................41
USING THE PROG/MENU KEYS.............................42
CLINICAL RESOURCES LIBRARY - CLINICAL
PROTOCOLS.......................................................44
REFERENCES.....................................................67
ACCESSORIES WHICH ACCOMPANY SONOPULSE III......69
TROUBLESHOOTING ..........................................71
MAINTENANCE, WARRANTY AND TECHNICAL
SUPPORT.............................................................71
CEFAI – IBRAMED CENTER FOR EDUCATION AND
ADVANCED TRAINING.........................................74

3
SYMBOL DEFINITIONS
Below are the denitions of the symbols used on the equipment and throughout the instructions found in this
manual. Understand these symbol and their denitions before operating this equipment.
Caution! Refer to user manual.
Alternating Current.
TYPE BF Electrical Equipment.
Dangerous Voltage.
CLASS II Electrical equipment.
Protected against dripping water.
O switch.
On switch.
Protected against the eects of immersion.
Combined therapy IN.
Start treatment.
Stop treatment.
Transducer.

4
SYMBOLS DEFINITIONS
CARTON
Fragile.
This side up.
Keep away from the rain.
Stacking up.
Do not use if the packaging is damaged.
Manufacturer’s name and address.
Refer to operating instructions for
correct product use.
Limits of temperature for storage and packaging
in °C (Celsius Degrees).

5
ABBREVIATIONS GLOSSARY
MHz
ERA
W
W/cm2
cm2
VA
BNR
Min
Megahertz (million pulses (106) by second)
Eective Radiating Area
Watt (s)
Watt (s) per square centimeter
Square centimeter
Volt Ampere
Beam Non-Uniformity Ratio
Minute
FIGURES GLOSSARY
Figure 1. Upper view................................................26
Figure 2. Rear view..................................................26
Figure 3. Frontal view...............................................27
Figure 4. Lower view.................................................27
Figure 5. A, Ultrasound transducer with ERA of 7 cm2;B,
neutral conductor gel..................................................31
Figure 6. A, presentation message; B, standard/default
SONOPULSE III screen..............................................32
Figure 7. Application technique.................................38
Figure 8. A, slot for combined therapy of SONOPULSE III;
B,connector cable for combined therapy..........................40
Figure 9. Application technique for combined therapy.......41
Figure 10. Message of selection of language.................42
Figure 11. Programmed and User protocols display.........43

6
FOREWORD PRODUCT DESCRIPTION
This user manual allows the user to eciently use the
SONOPULSE III. It also gives suggestions for treatment
protocols so that you can use your equipment to its full
potential.
Consult other resources for additional information regarding
the uses of ultrasound before attempting any treatment
on a patient. Users must read, understand and follow the
information in this manual for each mode of treatment
available, as well as the indications, contra indications,
warnings and precautions.
The specications and instructions in this manual are
in eect at the time of its publication. These instructions may
be updated at any time at the manufacturer’s discretion. Visit
our web site for updates.
ESSENTIAL PERFORMANCE
SONOPULSE III is a therapeutic ultrasound micro controlled
device in the frequencies of 1 MHz and 3 MHz, designed to be
used for aesthetic and physiotherapy treatments. SONOPULSE
III allows the choice of ERA (Eective Radiating Area) of 7
cm2, making it possible to select the 1 MHz frequency with
the ERA 7 cm2 or the frequency of 3 MHz with the ERA of 7
cm2. The average ultrasound output power is 21 Watts for the
ERA of 7 cm2, therefore, the maximum intensity is 3 W/cm2.
The ultrasound emission mode can be adjusted to continuous
or pulsed. The pulsed mode has pulse repetition frequencies
of 100 Hz, 48 Hz or 16 Hz, with pulse ratio of 1/2 (50%) or
1/5 (20%). SONOPULSE III has a PROG key, which allows
the user to choose a pre-programmed treatment.
Ultrasound delivered to the body using an ecient couplant
provides deep heating eects to body tissues. Ultrasound
delivered at a frequency of 1 MHz penetrates to a depth of
approximately 5 centimeters while ultrasound at a frequency
of 3 MHz penetrates tissue to a depth of approximately 1–2
cm.
This device must be used only under prescription and
supervision of a licensed professional.

7
SAFETY PRECAUTIONS
PRECAUTIONARY DEFINITIONS
The precautionary instructions found in this section and
throughout this manual are indicated by specic symbols.
Understand these symbols and their denitions before
operating this equipment prior to therapy session.
• Read, comprehend and practice the precaution and operation
instructions. Know the limitations and dangers associated with
the use of any electrical stimulation. Observe the precaution
and operation labels placed on this unit.
• Do not operate this unit in an environment where other
devices intentionally radiate electromagnetic energy in an
unprotected manner.
• Check the cables and connectors before each use.
• The SONOPULSE III stimulator is not designed to prevent
the penetration of water and other liquids. Penetration of
water and other liquids may cause malfunction of the internal
components of the system, and consequently, promote risk
of injure to the patient.
• Disconnect the plug from the power outlet when the device
is not used for long periods of time.
• The applicator should be operated only by the handle to
avoid exposure to unwanted emission of ultrasound.
Text with a “CAUTION” indicator refers to potential safety
infractions that could cause minor to moderate injury or
damage to equipment.
Text with a “WARNING” indicator refers to potential safety
infractions that could cause serious injury and equipment
damage.
Text with a “DANGER” indicator refers to potential safety
infractions that represent immediately life threatening
situations that would result in death or serious injury.

8
SAFETY PRECAUTIONS
• In order to be protected from the risk of re, use only spare
fuses of the same type and class.
• Make sure the unit is grounded, connecting it to a grounded
power outlet in conformity with the applicable local and
national electrical codes.
• Before treating the patient, it is necessary to know the
operational procedures for each treatment mode available,
as well as the indications, contra indications, warnings and
precautions. Refer to other sources to obtain additional
information on electrotherapy applications.
• To avoid electrical shock, turn the device o the power
supply line before any maintenance procedure.
• The ultrasound treatment must not be applied on swollen
infected or inamed areas, or on skin eruptions such as
phlebitis, thrombophlebitis, varicose veins, etc.
• Ultrasound treatment must not be applied on or next to
cancerous lesions.
• Patients with neurostimulation devices or implanted
pacemakers must be distant from any shortwave diathermy,
microwave diathermy, therapeutic ultrasound diathermy,
or laser diathermy and must not be treated with these on
any part of their bodies. The diathermy energy (shortwave,
microwave, ultrasound and laser) may be transferred through
the implanted neurostimulation system, and it may cause
damage to the tissues, and result in serious injury or death.
Damage, injury and death may occur during diathermy
therapy even if the implanted system is turned o.
• Equipment not suitable for use in the presence of a
ammable anesthetic mixture with air, oxygen or nitrous
oxide. Equipment is not the AP or APG category.

9
Therapeutic ultrasound is commonly indicated for:
• Pain relief
• Reduction of muscle spasm
• Localized increase in blood ow
• Increase in range of motion in contracted joints using heat
associated with stretch techniques.
Relief of pain, muscle spasms and contracted joints may be
associated with:
• Adhesive capsulitis.
• Bursitis with mild calcication.
• Myositis.
• Lesion of soft tissues.
• Post lesion shortening of tendons and scar.
Relief of chronic pain and muscle contracture may result from:
• Capsular tension.
• Capsular scar.
INDICATIONS
INDICATIONS AND PRECAUTIONS
PRECAUTIONS
• Ultrasound must not be applied in areas of reduced sensation
or circulation or over anesthetic areas. Patients with reduced
sensation are not capable of warning the professional in case
there is discomfort and in patients with compromised circulation
there may be an excessive buildup of heat in the treated area.
• Professionals operating the device on a daily basis must not
be exposed to therapeutic ultrasound. The applicators handles
have been developed to allow the professional to protect
the hands from ultrasound when performing underwater
treatment.
• If a patient complains of deep periosteal pain during
ultrasound treatment, the intensity should be reduced to a
comfortable level.
Heating must be avoided during the acute or sub-acute phase
of arthritis.
• Any bleeding tendency is increased by heating because
of the increase in blood ow and vascularity of the heated
tissues. Care, therefore, should be used in treating patients
with therapeutic ultrasound who have bleeding disorders.
• Examples of these are hemophilia, post acute trauma, long
term steroid therapy, cumiden or heparin therapy.
• Moving technique of the applicator should be used when
applying therapeutic ultrasound at intensities greater than
0.5W/cm2 to assure even exposure of tissues to ultrasound.
• Electrical treatment tables or whirlpools which may come
in contact with the patient during a treatment with the
SONOPULSE, should be adequately grounded and safety
tested to insure safe operation with the SONOPULSE.
The use of therapeutic levels of ultrasound may delay or
prevent callous formation in a healing fracture.

10
ADVERSE REACTIONS
• Therapeutic ultrasound, when applied in continuous circular
movements, may cause a sensation of numbness and/or
heat. If, however, the applicator is kept over the same place
for more than a few seconds in high energies, it may become
uncomfortable.
CONTRA INDICATIONS AND ADVERSE REACTIONS
• Therefore, therapeutic ultrasound should not be applied
over the uterus unless specic assurance can be attained
from the patient that she is not pregnant.
• Therapeutic ultrasound must not be applied over neoplastic
areas or over areas from which tumors have been removed.
• Therapeutic ultrasound must not be applied over the eyes.
• Therapeutic ultrasound must not be applied on ischemic
tissues, where the blood supply may be incapable of following
the increase in metabolic demand and result in necrosis.
• Therapeutic ultrasound must not be applied over bone
growth centers.
• Ultrasound therapy is not recommended for patients with
implanted electronic devices (cardiac pacemakers, deep brain
stimulation devices).
• Do not apply ultrasound over areas previously treated with
radiotherapy.
• Ultrasound must not be applied over the testes, to avoid
increases in temperatures.
• Ultrasound must not be applied over the heart.
Therapeutic ultrasound must not be applied over areas of
thrombophlebitis deep vein thrombosis emboli and severe
atherosclerosis.
• Ultrasound treatment must be avoided over the stellate
ganglion, spinal cord after laminectomy, when great tissue
resections have been performed, under subcutaneous major
nerves and the cranium.
CONTRA INDICATIONS

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PATIENT POPULATION
• Patients over 12 years old, under this age only by medical
prescription or physiotherapeutic indication;
• Patients over 35 kg, under this weight only by medical
prescription or physiotherapeutic indication;
• There are no restrictions as of nationality;
• Patients with preserved level of conscience and sensitivity.
• There are no admissible deciencies for the use of the
equipment;
• Regarding the frequency of use, this device is used according
to clinical needs, up to several times a day and is reusable;
• Regarding mobility, this device is considered a portable
device.
CONDITIONS OF USE
• There are no requisites about a maximum level of education
for the intended use.
• Regarding the minimum level of knowledge of the user, it is
necessary that the user knows the electro physical agents and
their therapeutical eects. The user must know physiology,
anatomy, and the basic sciences: chemistry, physics, and
biology. The user is supposed to have studied or be presently
studying physiology and anatomy;
• A maximum level of knowledge is not required from the
user;
• The instructions of use are available in Portuguese, Spanish
and English;
• Regarding the minimum level of experience of the user, it
is necessary that the instructions of use are read carefully
and all the instructions are understood before the use of the
device;
POPULATION AND CONDITIONS OF USE

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RESPONSIBILITY FOR USE ELECTROMEDICAL EQUIPMENT
The use of electromedical equipment is restricted to a physician or under his command, the physical therapists or health
professionals properly licensed.
The professional will be responsible for properly licensed use and operation of the equipment. IBRAMED makes no representations
regarding laws and federal, state or local laws that may apply to the use and operation of any electromedical equipment.
The physician or under his command, also the physical therapist or other professional health care licensed assumes total and full
commitment to contact the local certifying agencies to determine any credential required by law for clinical use and operation of
this equipment.
The use of electromedical equipment must comply with the local, state and federal country.

13
GENERAL EQUIPMENT CARE
SHIPPING DAMAGE
Your SONOPULSE III is shipped complete in one carton.
Upon receipt, inspect carton and unit for visible and hidden
damage. In case of damage, keep all shipping materials
including carton and contact the shipping agent responsible
for the delivery of the unit. All claims relating to damage during
transport should be led directly with them. The manufacturer
will not be liable for any damage during shipping, nor allow
for adjustments unless proper formal claim has been led
by the receiver against the carrier. The carton in which your
SONOPULSE III was received is specially designed to protect
the unit during shipping. Please keep all shipping materials in
case you need to return your unit for servicing.
INSTALLATION, CARE AND CLEANING
1. Connect the line cord to the back of the SONOPULSE
III.
2. Plug the line cord into a grounded wall outlet (100-240V
~ 50/60 Hz).
3. Plug the ultrasound cables into the correct connections.
4. Switch on your equipment.
Installation Instructions

14
• Avoid areas subject to vibrations.
• Install the equipment on a rm and level surface, in open
air.
• Do not block ventilation.
• Avoid humid, hot and dusty environments.
• Make sure the area around the network cable is free.
• Do not insert objects into device holes.
SONOPULSE III Care Instructions
GENERAL EQUIPMENT CARE
• Disconnect the system from the power source, wipe
with a clean, lint free cloth moistened with water and mild
antibacterial soap.
• If a more sterile cleaning is needed, use a cloth moistened
with an antimicrobial cleaner.
• Do not place the system in liquids.
Cleaning the SONOPULSE III
The SONOPULSE III is an electronic device and has heavy
metals such as lead. Thus, there are risks of contamination
to the environment associated with the disposal of this
equipment and its accessories at the end of their useful lives.
The SONOPULSE III, parts and accessories must be disposed
of as waste. Contact your local distributor for information
on rules and laws regarding the disposal of waste electrical,
electronic equipment and accessories.
ENVIRONMENTAL PROTECTION
THE DEVICE AND ITS CONSUMABLE PARTS MUST
BE DISPOSED OF, AT END OF LIFE, ACCORDING
TO THE APPLICABLE FEDERAL AND/OR STATE
AND /OR LOCAL REGULATIONS.
Proper installation, operation and maintenance of
the equipment prevents security risks.

15
GENERAL EQUIPMENT CARE
SONOPULSE III is a protective CLASS II device with applied
part type BF of safety and protection. SONOPULSE III
works in power supply tension in the range of 100 - 240V ~
50/60 Hz. Just connect the device to the power line and it
will perform the selection of power tension automatically. The
connector cable to the power supply line is detachable. The
device uses the power line plug as a resource to electrically
separate its circuits in relation to the power supply line in all
poles.
ELECTRICAL FEED
In the rear part of SONOPULSE III there is a protection fuse.
To replace it, turn the device o the power supply line
and with the help of a screwdriver, remove the protection lid,
disconnect the fuse, perform the replacement and reinsert
the lid.
Always use the fuses indicated by IBRAMED. Use a fuse for
nominal current of 5.0A, operation tension of 250V~ and
snap action model 20AG (50A rupture current).
SONOPULSE III does not need any type of power stabilizer.
Never use a power stabilizer.
NOTES
Before turning on SONOPULSE III make sure:
• The tension and frequency of the local power supply line of
the establishment where the device is installed are equal to
the one described on the label describing characteristics of
tension and power located at the rear part of the device.
• To prevent electrical shock, do not use the plug in the
device with extension cables, or any other types of sockets
except the terminals connect perfectly in the receptacle.
• Cleansing and disinfection must always be performed with
the power plug o of the power supply line.
• Maintenance and technical assistance of SONOPULSE III
must always be performed at unauthorized service, only by
qualied technicians.
Inside the device there are dangerous tensions.
Never open the device.

16
ELECTROMAGNETIC COMPATIBILITY GUIDANCE
• This unit is not designed to be used where there is explosion
hazard, such as anesthesia departments or in the presence
of an anesthetic ammable when mixed with air, oxygen or
nitrous oxide.
• Using cables, electrodes and other accessories from other
manufacturers and/or dierent from those specied in this
manual as well as the replacement of internal components
SONOPULSE III may result in increased emissions or
decreased immunity of the equipment.
• SONOPULSE III equipment is intended for use only by
health care professionals. The SONOPULSE III may cause
radio interference or disrupt equipment operations nearby.
It may be necessary to adopt mitigation procedures, such as
reorienting or relocating the equipment or shielding of the
site.
• Portable and Mobile Radio Frequency (RF) communications
equipment can aect Medical Electrical Devices.
As for the limits of electromagnetic interference, SONOPULSE
III is an electromagnetic device of Group 1 Class A. The
simultaneous connection from the patient to SONOPULSE
III and to high frequency surgical equipment may result
in burns in the ultrasonic transducer application area and
possible damage to the device. Short distance operation (1
meter, for example) of short wave or microwave therapy
equipment may produce instability in the output of the device.
To prevent electromagnetic interference, we suggest that one
group of power supply line is used for SONOPULSE III and
another separate group is used for short wave or microwave
equipment. We also suggest that the patient, SONOPULSE
III e and connection cables are installed at least 3 meters
away from short wave and microwave therapy equipment.
Medical Electrical Devices requires special attention regarding
Electromagnetic Compatibility (EMC) and must be installed
and put into service according to the EMC information provided
in the following tables.
POTENTIAL ELECTROMAGNETIC INTERFERENCE

17
ELECTROMAGNETIC COMPATIBILITY GUIDANCE
Manufacturer’s guidelines and declaration – Electromagnetic emissions
Emission test
RF Emissions
NBR IEC CISPR 11
IEC CISPR 11
Group 1
SONOPULSEIII emits RF energy only for its internal functions.
However, its RF emissions are very low and it is unlikely
to cause any interference in nearby electronic equipment.
SONOPULSE III is suitable to be used in all kinds of places
other than residential and which are not directly connected
to the public distribution of low voltage which supplies the
domestic buildings.
Class A
Class A
Class A
RF Emissions
NBR IEC CISPR 11
IEC CISPR 11
Harmonic Emissions
IEC 61000-3-2
Emissions due to the
uctuation/ scintillation
IEC 61000-3-3
Conformity Electromagnetic emissions
SONOPULSE III is destined to be used in the electromagnetic environment specied below. The user of the
equipment should be sure that it will be used in this environment.

18
Manufacturer’s guidelines and declaration – Electromagnetic immunity
Immunity Test Conformity level Electromagnetic environment – orientations Test level
IEC 60601
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV by contact
± 8 kV by air
± 6 kV by contact
± 8 kV by air
± 2 kV in the
feeding lines
± 1 kV in the
input/output lines
± 2 kV in the
feeding lines
± 1 kV in the
input/output lines
± 1 kV dierential
mode
± 2 kV common
mode
± 1 kV dierential
mode
± 2 kV common
mode
Fast electric
transitories /
pulse train
(Burst)
IEC 61000-4-4
The quality of power supply should be that of
a hospital environment a or typical commercial
building.
The quality of power supply should be that of a
typical commercial or hospital environment.
Outbreaks
IEC 61000-4-5
The oor should be wooden, concrete or ceramic.
If oors are covered with synthetic material,
the relative humidity should be at least 30%.
SONOPULSE III is destined to be used in the electromagnetic environment specied below. The user of the equipment
should ensure that it is used in such environment.
ELECTROMAGNETIC COMPATIBILITY GUIDANCE

19
Immunity
test
Conformity level Electromagnetic environment -orientations
Test level
IEC 60601
Voltage drops,
short interruptions
and voltage
variations in
power input lines
IEC 61000-4-11
Magnetic eld at
power frequency
(50/60 Hz)
IEC 61000-4-8
< 5% U
(> 95% voltage drops
in U ) by 0,5 cycle
40% U
(60% of voltage drops
in U )by 5 cycles
70% U
(30% of voltage drops
in U ) by 25 cycles
< 5% U
(> 95% of voltage
drops in U ) by 5
seconds
3 A/m 3 A/m
< 5% U
(> 95 % voltage drops
in U ) by 0,5 cycle
40% U
(60% of voltage drops
in U ) by 5 cycles
70% U
(30% of voltage drops
in U ) by 25 cycles
< 5% U
(> 95% of voltage
drops in U ) by 5
seconds
The quality of power supply should be
that of a typical commercial or hospital
environment. If the user’s equipment requires
continued operation during power failure, it
is recommended the equipment be powered
by an uninterruptible power supply or battery.
Magnetic elds at power frequency should be
at the level of a typical location in a typical
commercial or hospital environment.
NOTE: UT is the C.A. voltage before applying the test
ELECTROMAGNETIC COMPATIBILITY GUIDANCE

20
Manufacturer’s guidelines and declaration – Electromagnetic immunity
Immunity
test Electromagnetic environment – guidelines
Test level
IEC 60601
Conformity
level
RF Conducted
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz 3 V
RF Radiated
IEC 61000-4-3
3 V/m
80 MHz to 2.5 GHz 3 V/m
Communication equipment of RF portable and mobile
should not be used near any part of SONOPULSE III
including cable with separation distances smaller than the
recommended, calculated from the equation applicable to
the transmitter frequency
Recommended separation distance
d = 1.2
d = 1.2 80 MHz to 800 MHz
d = 2.4 800 MHz to 2.5 GHz
Where P is the maximum nominal output power in watts
(W) according to the transmitter manufacturer and d is
the recommended separation distance in meters (m). It
is recommended that the eld intensity established by
the RF transmitter, as determined by an electromagnetic
inspection on the local, be smaller than the conformity
level in each frequency range . Interference may occur
around the equipment marked with this symbol:
SONOPULSE III is destined to be used in the electromagnetic environment specied below. The user of the
equipment should ensure that it is used in such environment.
ELECTROMAGNETIC COMPATIBILITY GUIDANCE
P
P
P