SONOMED V

4150 - 1&3 MHz

Tables of contents

02 ............. Presentation

Sonomed V

02 .............Accessories supplied with the device

03 .............General Information

05 .............Symbols

06 .............Installation / Connection to mains supply

4150





08 .............Installation of Transductor Support
09 .............Display Language
09 .............Ultrasound energy

10 .............Ultrasound therapy

11 .............Continuous and Pulsed Mode

11 .............Cases where the Pulsed mode is advised

12..............Graphic representation of Pulsed Mode

User Manual





14 .............Operational Flow Chart
15 .............Controls
17 .............Appliance operation

18 .............Protocols

22 .............Indications

24 .............Contraindications

24 .............Corrective maintenance

25 .............Preventive maintenance and conservation

25 .............Precaution Instructions

26 .............Technical Specifications

29 .............Declarations

33 .............Final considerations

34 .............Bibliographical References

English

Revision : 06

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Presentation General Information

Carci is proud to congratulate you for the acquisition of a high technology The Ultrasound CARCI SONOMED V was developed with the purpose of providing
and security equipment. Where we are sure this equipment will satisfy the the essential support that the ultrasound technology allows to the clinical
highest quality standards. physiotherapy practice.
The Ultrasound is a mechanical stimulus directed to the body through ultrasonic
SONOMED V – 4150 device was designed according to IEC 60601.1:1994 beam emitted by a transducer / applicator, better known as head. This Ultrasound is
+ amend 1:1997, IEC 60601-1-2:2006 and IEC 60601-2-5:1997 safety produced in the head through a piezo-electric crystal and transmitted to the body
rules, which makes them a safe and reliable product. through the aluminum surface of the head and a contact agent (gel). As the
Ultrasound beam crosses the tissues, its energy is gradually and selectively
Accessories supplied with the device absorbed, and among other effects, being transformed into heat. This increase of
temperature provokes biological alterations in the tissues, as well an increase in the
micro-circulation, a reduced perception of pain, a reduction of inflammatory activity
SONOMED V 4150 and an increase in the restoration rate of delicate tissues. The higher the frequency
2 of the Ultrasound, the more superficial its absorption will be, as it may be seen in the
• 01 Transductor 5 cm figure below:
• freqüêncy: 1,0 and 3,3 MHz
• 01 Acrylic Transductor Support
• 01 Adhesive for fixing the Support in the device
• 01 Tripolar Cable 1 Mhz 3 Mhz
• 01 Gel Tube – 200ml Effective
• 01 User’s manual
Effec tive 1c m depth
depth Penetrating
3c m 3c m point

To buy optional accessories, please verify the codes at page 28, item : Penetrating
point 9c m
Accessories.
If you have any doubt, please contact:

Technical Assistance Department

Rua Álvares Fagundes, 359 – Americanópolis
São Paulo – SP – Brasil -CEP 04338-000
Tel.: (0XX11) 5621 7024 / 5622 8205
e-mail : sat@carci.com.br

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Symbols
In the application of Pulsed Ultrasound in low frequencies (48Hz and 16Hz), a
reduction is observed in the heat produced in the tissues, and certain non-thermal
Equipment symbols
effects are obtained at cell level, such as an increase in the permeability level of the
cell membranes and a reduction in the inflammatory actions. Equipment off
The mechanical and electrical characteristics of the transducer are a result of
intense researches carried out intending to obtain a regular ultrasound beam and
Equipment on
with no diffusion. These characteristics were obtained through the measurement of
the acoustic field in the transducer and subsequently, graphic analysis of the relative
pressure in function of the distance of the transducer where ERA (effective radiation
This equipment has physiological effects.
area) and BNR (non-uniformity relation of the ultrasound beam) were determined.
Consult instructions manual.

An intensity indicating scale was determined through the method of measuring the
pressure of the acoustic radiation by using a digital Wattmeter, which allowed for
Applied part is type BF
great accuracy in the values of intensity scale (dosages).
The decision of using Ultrasound therapy as a form of treatment for your patient
should always be substantiated on a deep clinical knowledge of the pathology and Manufacturing date
in an intimate understanding of the possibilities and limitations of Ultrasound
therapy.
Serial number

Manufacturer identification

IPX7 This symbol indicates that the head is waterproof.

This symbol indicates that the equipment isn’t

IPX0 waterproof.

Class II Equipment

CE Mark and certifying body identification

European representative

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Symbols on the pack The electric power supply’s voltage must be within the range specified in the
Technical Features, otherwise, there can be reduced equipment performance
and safety risk.

Caution fragile. Handle with care • Connect the power cable to a three-pin connector located in the back panel
and connect it to the power supply socket

Keep in a dry place

This side up. This symbol indicates the right

transport position

Maximum piling. Indicates the maximum number of

boxes that can be piled. The quantity is marked in
the intermediary square.

Minimum and maximum temperature limits for
transport and storage.
• Your equipment uses switched power supply and operates in any voltage
between 100V~ and 240V~ 50 or 60Hz.
• In case of blowing up the protection fuse replace it only with the appropriate
value:
The fuses should be: 2.0A 250V 20AG

Installation / Connection to mains supply Remove the lid of the fuse holder with the help of a screwdriver (insert the point of
the screwdriver in the groove of the fuse holder, apply light pressure and turn to the
For perfect operation of your equipment, we suggest that the electrical installations counterclockwise direction)
comply with the following standards:

 Brazil:
• NBR 5410/1990 – Low-voltage electrical installations;
• NBR13534/1995 – Electrical installations in health establishments –
Safety requisites.
 Other countries:
• IEC 60364-7-710/2002 – Electrical installations – medical locations;
• Or another listed standard applied in the country of use.

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Installation of Transductor Support Display language

1° Step 2° Step SONOMED allows three display languages to be accessed:
Paste the adhesive in the acrylic Remove the protection cover  Portuguese
According Picture below:  English
 Spanish

Protection cover In case you wish to change the current language, follow the steps below:

1. Connect the SONOMED’s power cable to the electric network.

2. Switch on the device – the equipment will test the display and
processor circuit, and will emit a double beep in case there is
Acrylic Support Adhesive no problem
esivo 3. Next, press and hold the key
3° Step
Choose the side and paste the Acrylic support in the device, according to Picture Protocols
below:
4. After the equipment emits a double beep, release the
Protocols key.
5. The display will show the accessible languages:
ENGLISH
PORTUGUESE
SPANISH
OR 6. Select the desired language through the keys
Left side Right side
esquerdo
4º Step
Fit the transductor in the Acrylic Support.
7. Press the key Set
8. Switch off the SONOMED.

Ultrasound Energy
It is a form of energy obtained when an electric oscillating voltage is applied on a
transducer that, for its piezo-electrical characteristics, deforms, expanding and
contracting in the same frequency as the applied electric voltage. This way,
ultrasound waves are produced that have fundamentally great capacity of in-depth
heating of tissues.

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4150 - 1&3 MHz
Ultrasound therapy
It is the use of ultrasonic energy for treating the problems of the musculoskeletal
system. For this purpose we use an application device referred to transducer. The
transducer should be used appropriately through slow circular and repetitive
movements. An area of approximately 7.0 cm x 10.0 cm should be treated each
time.
• In some cases, the pain can increase after the treatment. This fact can be
explained by the concentration of the ultrasonic waves in the interfaces of non-
similar tissues such as, for example, skin-fat, periosteum-bone, which have a poor
blood vascularization and suffer temperature increase due to the reflected energy
(2). In these cases the treatment should continue normally, however, with a
reduction in the intensity and in the time of application.
• Temperature elevation resulting from ultrasound absorption by the tissues can
cause an increase in the extensibility of collagen tissues (3). In this sense, this
heating is indicated for treating the pathological conditions caused by tissue
contraction such as tendons, ligaments and capsular joints.
• In the cases where there is limitation of movements caused by the contraction of
the tissues and in the diseases of collagen (such as rheumatic arthritis) the
treatment produces significant effect.
• Diseases of sinovial membranes (such as bursitis), and other membranes that act
in the ligament of the major joints respond particularly well to the treatment by
ultrasound (4).
• Depth heat affects muscles temperature . A five minutes treatment can lift up the
temperature from one to two degrees centigrade. The effects of the heat associated
to that of micro-massage provoke a relaxation of the muscles, and consequently
largely reduce the muscular spasms with localized nature (2).
• The ultrasound has an anti-inflammatory effect when applied on the peripheral
nerves. Literatures (5) and (6) reveal that in this case cortisol is released (anti-
inflammatory substance) which contributes to reduce the trauma. In this sense, the
ultrasound is indicated as a therapeutic agent for treating the irritations of the back
sacral nerve roots.
• Other mechanisms of defense of the body can be stimulated as result of the
increased temperature. This fact can be explained by the increase in blood flow, and
the consequent vascularization of a region where there is an inflammatory reaction.
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SONOMED V
4150 - 1&3 MHz
Continuous and Pulsed Mode
Originally the ultrasound for physiotherapeutic purposes was available only in the
form of waves produced in continuous mode, which basically have the purpose of
producing heat and exercising in-depth micro-massage. Currently, we have
ultrasound in the Pulsed mode, which has been quickly recognized as the most
important progress in treatment techniques.
When the therapy is applied through continuous waves, the ultrasonic energy
emitted by the transducer - applier produces a continuous growth in the heating of
the tissues and the treatment can become intolerable, mainly in case of more acute
and recent traumas. One of the causes for the excessive heating is when the
application is made near to the surface of the bones; the subperiostal blood
vascularization is poor and, therefore, it does not contribute to disperse heat.
In the sense of improving the problem of the effects associated to the undesirable
heating, a circuit was developed where the transducer – applicator generates pulses
of waves, which emits energy in periodic mode where, through the resting time
between the pulses, blood circulation cools the treated area, thus impeding excess
heating.
Another effect what we can quote is that the permeability of the membranes is
altered not only by thermal effects, but also because minute currents produced by
the ultrasound can increase the rate of diffusion and the gradient of concentration of
the membranes, according to studies of Lehman, Becker and Other (7).
Cases where Pulsed mode is advised
In many cases the heat is undesirable, because it causes pain and discomfort to a
patient; in this case the treatment can be carried out by Pulsed wave. The areas and
conditions that respond particularly well to this treatment are the following:
• Traumatic Amputation of the distal phalanx of the fingers, with formation of a
sensitive area and painful scars. There is the need for a neural analgesic effect,
without causing superheating of the bones that are quite near to the skin. For these
cases the application by using the sub-aquatic technique is predicted.
2
Recommended intensity: 0.8 W/cm starting the treatment with three minutes and
increasing the next treatments up to at most 10 min.
• Crushed hands and feet. The immediate use of ultrasound prevents the formation
of fibrous tissues through the absorption of the cell hemorrhage. In the cases where
the trauma allows this procedure, it brings about quick restoration of the functions.
2
Recommended intensity: 1.0 W/cm for a quick absorption of the edema. The
treatments should have 5-min duration.
• Pains originated in the nervous roots. Sudden painful demonstrations in the back
of the legs. The movements are slow and limited due to the sharp pain and spasms.
The patient walks in inclined mode (scoliosis) and does not execute frontal flexing.
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The nerve roots to be treated should be specified by the therapist (cervical, dorsal or
lombosacral region). The Pulsed ultrasound is recommended for the maximum
2
neural effect. Recommended intensity: from 1.0 to 1.5 W/cm depending on the
thickness of the muscle existing between the skin and the target to be reached. The Amplitude
appropriate period of time is about 5 min for analgesia and pain relief.
• Dislocation or peri-articulatory fractures. In these cases the immediate use of
ultrasound inhibits the formation of adherences resulting from non-absorption of 10 % T on
2
extra cell hemorrhage. Recommended intensity: 1.5 W/cm with treatment time of
about 5 min.
Other conditions reported by Cyaruax (9) that respond very well to the treatment by
Pulsed ultrasound: hematomas, hypertrophic scars and certain muscular traumas.
In this last case the ultrasound provokes an alignment of the healthy fibers along the Time
longitudinal axle of the muscle. T
T off

Graphic representation of Pulsed Mode

f=1/T

Amplitude

Work cycle:
50 % T on
50% 20% 10%
Freq. (f) Period (T) Ton Toff Ton Toff Ton Toff
100Hz 10ms 5ms 5ms 2ms 8ms 1ms 9 ms
48Hz ~20ms Non-applicable 4ms 16ms 2ms 18 ms
16Hz ~62ms Non-applicable 12ms 50ms 6ms 56ms
Time
Relation Ton/Toff 1:2 1:5 1:9
T off
T

f=1/T f (frequency) = 1/T (period)

Ton = active Time
Toff = resting Time
Amplitude

20% T on 100Hz with work cycle of 10 %, 20 % or 50 %

That is for 10 % 1 ms active time and 9ms rest – 1:9 ratio
20 % 1 ms active time and 8ms rest – 1:5 ratio
50 % 1 ms active time and 5ms rest – 1:2 ratio
48 Hz with work cycle of 10 % or 20 %
Time
That is for 10 % 2 ms active time and 18ms rest – 1:9 ratio
20 % 4 ms active time and 16ms rest – 1:5 ratio
T off
T 16 Hz with work cycle of 10 % or 20 %
f=1/T This is for 10 % 6 ms active time and 56ms rest – 1:9 ratio
20 % 12 ms active time and 50ms rest – 1:5 ratio

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4150 - 1&3 MHz 4150 - 1&3 MHz

C o n t r ol s
FLOWCHART FOR ULTRASOUND THERAPY

Pathology to be treated

ACUTE
ACUTE OR CHRONIC
CHRONIC

DESIRABLE UNDESIRABLE
THERMAL THERMAL
EFFECT EFFECT

DEPTH
CONTINUOUS
MODE
TO BE
REACHED
PULSED
MODE Cursor Movement Keys:

US Yes MORE No US
THEN
1 MHz 1 cm 3 MHz

TYPE OF APPLICATION :
STANDARD (GEL) / SONOPHORESIS / UNDER WATER

CHOOSE APPLICATION PARAMETERS

Start Therapy

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4150 - 1&3 MHz 4150 - 1&3 MHz

Appliance operation
W Sta rt 1. Connect the transductor in Sonomed, according to Picture below :
Protocols Set 2
W/cm Stop

1.0/ 3.3 MHz

Transductor :

Transductor Characteristics 2. Connect the Power cable in the Sonomed than in Power grid.

3. Turn on the appliance – the equipment will perform a test of the display
SONOMED UHT 4100 and the circuit of the processor and will issue a double beep in case it is
1.0 /3.3 Mhz IPX7 Collimating failure free
Era: 3,5 cm P.Max:7,2 W
BNR<6:1 S/N: 4150zzzz 4. Select through the keys the wanted parameters:

Áreas indication Support position

For selecting the wanted Value use:

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The values that can be selected in the continuous mode are as follows: Limitations of Liability

Frequency 1 / 3 MHz

Mode: Continuous / Pulsed In no case Carci Ind. e Com. e Com., or its suppliers and / or distributors,

Timer: 0 to 20 min. are liable by any indirect, special, incidental damage caused by the use or
2

Intensity: 0.0 to 2.0 W/cm inability to use the product, including, without limitation of damages due to
loss, or any and all other commercial damage or loss, and independently of
In the Pulsed mode: the legal or equitable theory (contract, appeal or another mode) on which

Frequency 1 / 3 MHz the claim is based.

Modulation frequency: 16/48 or 100 Hz Carci cannot be held responsible for any consequence resulting from

Work cycle: 10 / 20 or 50%* *(Only for 100Hz) incorrect information provided by its staff, or errors included in this manual

Timer: 0 to 20 min. and / or another attached documentation (including commercial
2

Intensity: 0.0 to 3.0 W/cm documentation)
Sonomed V has around 15 treatment protocols suggestions and enables
5. Apply the gel on the area to be treated record 18 user protocols.
Sta rt Below, a description of the protocols according to the application area, for
6. Position the transducer and press the key and the output the frequencies: 1MHz and 3.3 MHz, recorded in Sonomed V memory:
Stop
circuit will be turned on.

7. Upon ending up the treatment a double beep will sound and the output
circuit will be disabled.
Sta rt
8. Press the key Stop

Protocols

Atention

Before applying the treatment protocols the operator should be well

informed about the contents of this manual as well as on the operation of
this equipment and all aspects related with the treatment of the patient.

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4150 - 1&3 MHz 4150 - 1&3 MHz

In case you want to use the PROTOCOLS, press the key Protocols
1 2 3 4 5 6 7 8 9 0
Use the and keys
 The display will give the a b c d e f g h i j
to select the letter desired.
Following screen : k l mn o p q r s t
PROTOCOLS
u v wx y z ç , .
BACK Stp to DEL
SAVE Press the key to write,
USER test rec
Use the keys to FIX
select the desired PROTOCOL. or the key to erase.
1. BACK  Go back to the main To record the protocols press the key: Protocols
screen . PROTOCOLS
FREQUENCY 1 MHz
MODE CONTINUOUS
FREQUENCY
Press the key to Return. PROTOCOLS TEST REC
DUTY CYCLE This display shows the main screen FREQUENCY 1 MHz
TIMER INTENSITY MODE CONTINUOUS
2.SAVE  Record the protocol in the 0 min 0,0 W/cm2 FREQUENCY
memory. DUTY CYCLE
TIMER INTENSITY
10 min 1,0 W/cm2

Press the key to select the record mode. 3. USER’S  The display will give the following Protocols recorded

The display will give the following

screen 1 2 3 4 5 6 7 8 9 0 PROTOCOLS W TO DEL
a b c d e f g h i j Press the key to enable the XXXXX
k l mn o p q r s t Selected mode User’s. YYYYY
u v wx y z ç , . ZZZZZ
Stp to DEL

--------------

OBS.: If the parameters timer and intensity are in blanck it will not be Use the keys to select the Protocol desired, and Press the
possible to save
key to enable the selected Protocol.

For erase the Protocol, select the Protocol desired and press the

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4150 - 1&3 MHz 4150 - 1&3 MHz

• Bursitis
key. PROTOCOLOS STP TO DEL • Causalgias
XXXXX
• Coccygodynias
YYYYY
The display will give the following ZZZZZ DELETE ? • Neuritis
screen : SET = YES • Intercostal neuralgia
PROTOC = NO • Osteitis
• Chronic Periarteritis
• Reynaud’s Disease
Protocols
For erase press the key, or the to keep. • Herpes Zoster
• Mialgias
• Intermittent claudication
To return to main screen, you must to select a Protocol and press • Mielitis
• Prostatitis
key PROTOCOLS • Radiculitis
MAIN
Hand • Sciatic
4. FIX  The display will give the Shoulder • Front Sinusitis
following Sonomed Protocols. Elbow • Maxillary Sinusitis
Hip
Knee
• Escaleno’s Syndrome
BURSITE • Tenovaginitis
• Veined Stasis Ulcer.
Use the keys to select the protocol desired, and Press the • Lumbago
• Different rheumatisms
key to enable the selected Protocol. • Sudeck’s Atrophy

Common cases found in athletes who may respond well to the treatment by
Indications of Ultrasound ultrasound as adjuvant therapeutic agent:

The indications presented by the literature are based on biophysics • Injuries

researches, which in most of the cases coincide with those originating from • Neuritis
the empiricism developed by the clinical practice. These indications are • Arthritis
based fundamentally on the capacity of the ultrasound in selectively heating • Distensions
the tissues. • Adherences
• Sciatic
The ultrasound has been used successfully as joint therapy in the following • Edemas
general cases: • Scars
• Bursitis
• Arthrosis (large and small articulations) • Traumas
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• Stiff necks
• Tenosinovitis
• Sacro-Iliac distension
Contraindications
• Womb in the pregnancy
• Area of tromboflebitis
• Post-surgery areas
• Heart and pacemaker users
• Cerebral tissue
• Eyeball
• Reproductive organs
• Acute infections
• Areas treated by radiotherapy
• Tumors
Corrective Maintenance
PROBLEMS
EQUIPMENT:
DOES NOT TURN ON
EQUIPMENT TURNS ON, BUT
THE DISPLAY DO NOT SHOW
ANY INFORMATION
DISPLAY INDICATES
NO HEAD
PATIENT DISCOMFORT DUE
TO TRANSDUCER
TEMPERATURE INCREASE
DISPLAY INDICATES
ERROR HEAD
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SONOMED V
4150 - 1&3 MHz
SOLUTIONS:
• CHECK IF THE POWER CABLE IS REALLY
CONNECTED TO THE MAINS SUPPLY.
• CHECK IF THE FUSE IS NOT BLOWN UP.
• CONTACT THE TECHNICAL SUPPORT
• TURN OFF THE EQUIPMENT, WAIT A FEW
SECOUNDS AND TURN IT ON AGAIN.
• CONTACT THE TECHNICAL SUPPORT
• CHECK IF THE TRANSDUCER POWER
CABLE IS REALLY CONNECTED
• IF AFFIRMATIVE AND IF THE ERROR
INFORMATION PERSISTS, CONTACT THE
TECHNICAL SUPPORT
• APPLY A LARGER QUANTITY OF GEL ON
THE REGION UNDER TREATMENT.
• APPLY THE ULTRASOUND IN SLOW,
CIRCULAR AND CONTINUOUS
MOVEMENTS
• REDUCE OUTPUT INTENSITY
• CHECK IF THE TRANSDUCER POWER
CABLE IS REALLY CONNECTED
• IF AFFIRMATIVE AND IF THE ERROR
24
SONOMED V
4150 - 1&3 MHz
INFORMATION PERSISTS, CONTACT THE
TECHNICAL SUPPORT
OBS.: esquemas Elétricos, circuitos e listas de peças não são fornecidos a
consumidores finais. Em caso de necessidade contate a Assistência Técnica
Autorizada CARCI
Preventive Maintenance and Conservation
 We recommend that your SONOMED should be inspected and calibrated once
yearly, by the factory or authorized technical assistance;
 We recommend that the user weekly inspect, the cable of the transducer and
power cable certifying that the cables are not twisted or its insulation is
damaged, that the connections of the cables in the connectors are in perfect
conditions.
 We recommend that user, before each use, check for cracks in the transductor
that allow entry of water and if there is no gel accumulated on the side of the
transductor;
 Use only water and soap for cleaning the transductor. Avoid using alcohol
except on the aluminum surface.
 Use a damp cloth to clean the box of your device. Do not clean by
pulverization or immersion.
 Be sure the device is disconnected from the main power supply before
cleaning it. Avoid wetting the electric power contacts of cables and connectors
 The estimated useful life time of this device is 5 year. After this period it is
recommended that the equipment is subjected to a complete CARCI
inspection, so it can continue been safely and efficiently used.
 Do not replace the tripolar cable or the transductor by another model than that
specified by CARCI. The transductor should not be changed without a new
adjustment in the factory or authorized technical assistance. Otherwise it can
cause degradation of safety or change the output parameters of the product.
Precaution Instructions

Be acquainted intimately with this manual. Remain up-to-date on the
progresses in the therapy by Ultrasound and take all the adequate preventive
measures;

Do not use ultrasound equipment next to Short Waves or microwave equipment
when these are in operation;
Maintain this equipment out of reach of children;


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All Technical Support work for your appliance should be carried out by properly : Power in W (SATP*)
Authorized and Qualified people; • Maximum effective output power

Do not permit the lid of the transducer to heat excessively and repeatedly; and • Continuous mode : 7,2 W ± 20%
do not cool the same with icy water or ice to not damage the crystal; • Pulse mode : 10,5 W ± 20%

Falls of the transductor (head) can damage it completely or change the output • Maximum effective intensity :
parameters. Handle the transductor with care; • Continuous mode : 2 W/Cm
2

Do not dispose this equipment or accessories in the ordinary trash, at the end • Pulse mode : 3 W/Cm
2
of its useful life. There are substances in the equipment that can be harmful to • Modulation in pulse mode (square wave):
nature If no treated properly. In need of disposal of the equipment or its
accessories, submit the material to CARCI, which will provide the appropriate
• Pulse frequency 100 Hz (±20%)
treatment.
Work cycle 10% during 1ms pulses: time ratio 1:9

This equipment does not have protection against water penetration (IPX0). In
20% during 2ms pulses: time ratio 1:5
the case of accidental water penetration inside the equipment, do not 50% during 5ms pulses: time ratio 1:2
connect it to the electric network and send it over to technical
assistance to check for any damage that may have occurred. • Pulse frequency 48 Hz (±20%)
Work cycle 10% during 2ms pulses: time ratio 1:9
20% during 4ms pulses: time ratio 1:5
Technical specifications • Pulse frequency 16 Hz (±20%)
Work cycle 10% during 6ms pulses: time ratio 1:9
• Origin : CARCI – Brazil 20% during 12ms pulses: time ratio 1:5
• Model :SONOMED V 4150 • Timer : 1 to 20 min
• Function and application : ultrasound generating • Accuracy : 1 to 5 min. ±30 sec.
equipment for therapy. : 5 to 10 min. ±10%
• Electric supply : 100–230 V~ automatic : 10 to 20 min. ±1 min.
(± 10%) / 50 / 60 Hz • Size (LxAxP) cm: 30 x 11 x 20
• Maximum consumption : 65 VA • Weight : 1.2 Kg
• Fuses : 2.0A 250V 20AG
• Registro Anvisa : AM: 10314290018 * SATP (Spatial Average Temporal Peak) – Mean power value

----------------------------------------------------------------------------------------------------
• Classification of agreement with IEC 60601.1 and IEC 60601.2.5 standards:
- Type of protection against electric shock:..........................................class II
- Degree of protection against electric shock of the applied part:......BF Type
- Degree of protection against harmful penetration of water:..................IPX0
- Disinfections methods:.....................................see preventive maintenance
- Degree of application safety in the presence of an inflammable anesthetic mixture
with air, oxygen or nitrous oxide:...................................not adequate
- Mode of operation:.......................................................................continuous
----------------------------------------------------------------------------------------------------
• Operating Frequency : 1,0 & 3.3 MHz ± 5%
• Mode of Operation of U.S output : Continuous and Pulse
2
• Indication of output control : Intensity in W/Cm

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H e a d Ap p l i c a t o r ( t r a n s d u c e r ) :
• Type : Collimated DECLARATION OF MANUFACTURER AND INSTRUCTION –
• Operating Frequency : 1 & 3 MHz ± 5% ELECTROMAGNETIC EMISSIONS
2
• Aplicator area : 10 cm
• Geometric Area Transducer : 5 cm
2 SONOMED is destined for use in electromagnetic environment described below.
• Effective Radiation Area (ERA)
2
: 3.6cm ± 20% The SONOMED buyer or operator should ensure that it is in use in such
• Max. Intensity Ratio (BNR) : < 6.0 environment.
• Water tightness : IPX7 Electromagnetic environment
Emission testing Compliance
• Weight : 215 grams - instruction
• Maximum acoustic power : 10 Watts SONOMED uses RF power only
for its internal functioning.
Equipment operating conditions: RF emission Therefore, its RF emission is
Environmental temperature : +15ºC to +40ºC Group 1
• CISPR 11 very low and does not probably
• Relative humidity : 0% to 80% cause any interference in other
• Atmospheric pressure : 700 hPa to 1060hPa close by electronic equipment.
RF emission SONOMED is destined for use
Class B
Environmental conditions for transport and storage: CISPR 11 in all establishments, including
o
• Environmental temperature : -10ºC to 50 C Harmonic emission domestic and those directly
Class A
• Relative humidity : 20% to 90% IEC 61000-3-2 connected to the public electric
• Atmospheric pressure : 500hPa to 1060hPa Voltage fluctuation / network that supplies power to
Flicker emission Compliant buildings with domestic
IEC 61000-3-3 purposes.
Accessories:
DECLARATION OF MANUFACTURER AND INSTRUCTION –
2 ELECTROMAGNETIC IMMUNITY
• Transdutor 5 cm , freqüêncy 1,0 and 3,3 MHz Code 17666G
• Acrylic Transductor Support Code 19343G SONOMED is destined for use in the electromagnetic environment specified below.
The SONOMED buyer or operator should ensure that it is in use in such
• Adhesive for fixing the Support in the device Code 19738G environment.
• Tripolar Cable Code 14747G
Immunity Level of IEC Level of Electromagnetic
• Gel Tube – 200ml Code 7000/200 testing 60601 testing compliance environment - instruction
• User manual Code MU4150 The floor should be
wooden, concrete or
Electrostatic ceramic. If the floor is
± 6 kV contact ± 6 kV contact
discharge covered with a
± 8 kV air ± 8 kV air
IEC 61000-4-2 shumidiynthetic material,
the relative ty of air should
be at least 30 %.

MU_4150_ENG_Rev_04_092009 28 MU_4150_ENG_Rev_04_092009 29
 SONOMED V SONOMED V
4150 - 1&3 MHz 4150 - 1&3 MHz

Immunity Level of IEC Level of Electromagnetic DECLARATION OF MANUFACTURER AND INSTRUCTION –

testing 60601 testing compliance environment - instruction ELECTROMAGNETIC IMMUNITY
Fast transient / ± 2 kV mains ± 2 kV mains SONOMED is destined for use in the electromagnetic environment specified below.
Bursts ± 1 kV in and out The SONOMED buyer or operator should ensure that it is in use in such
IEC 61000-4-4 signal line Not applicable environment.
± 1 kV Level of IEC
Immunity Level of Electromagnetic environment -
± 1 kV differential 60601
testing compliance instruction
Surge differential mode mode testing
IEC 61000-4-5 ± 2 kV common ± 2 kV Portable and mobile RF
mode common communication equipment should
mode not be used closer to any
<5% Ut SONOMED part, including cables,
<5% Ut (>95% drop in than the recommended separation
(>95% drop in Ut) The electric network quality distance calculated from the
Ut) For 0.5 cycle should be that of a normal equation applicable for the
For 0.5 cycle hospital or commercial transmitter frequency.
40% Ut environment. Recommended separation distance
Voltage drop, 40% Ut (60% drop in Conducted 3 Vrms
short cut-offs (60% drop in Ut) Ut) RF 150 kHz to 80 3V d = 1.17. P 80 MHz to 800
and voltage For 5 cycles For 5 cycles IEC 61000- MHz MHz
variations in 4-6
electric power 70% Ut 70% Ut
supply. (30% drop in Ut) (30% drop in Radiated 3 V/m 3 V/m
IEC 61000-4-11 For 25 cycles Ut) RF 80 MHz to 2.5 d = 2 .3 . P 800 MHz to 2.5
For 25 cycles IEC 61000- GHz GHz
<5% Ut 4-3
(>95% drop in <5% Ut Where P is the maximum output
Ut) (>95% drop in power of the transmitter in watts
For 5 s Ut) (W), according to the transmitter
For 5 s manufacturer, and d is the
Magnetic fields 3 A/m 3 A/m The magnetic fields of recommended separation distance
of network network frequencies should in meters (m).
frequencies be the characteristic level of
(50/60 Hz) a normal commercial or The field generated by fixed RF
IEC 61000-4-8 hospital environment. transmitters, as determined by an
Note: Ut is the voltage of AC network before application of testing level. electromagnetic field study on the
a
location , should be lesser than the
level of compliance in each
b
frequency range.

Interference can occur around the

equipment with the following

MU_4150_ENG_Rev_04_092009 30 MU_4150_ENG_Rev_04_092009 31
 SONOMED V SONOMED V
4150 - 1&3 MHz 4150 - 1&3 MHz

symbol: recommended separation distance (d in meters) can be determined using the

equation applicable to transmitter frequency; P is the maximum output power of
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: to 80 MHz and 800 MHz, applies to the separation distance for the highest
frequency.
NOTE 2: this procedure can apply to all situations. The electromagnetic propagation
is affected by absorption and reflection of structures, objects and people.
NOTE 1: in the range of 80 MHz and 800 MHz, it applies the highest frequency of
the range. Final considerations
NOTE 2: this procedure may not apply to all the situations. The electromagnetic
propagation is affected by absorption and reflection of structures, objects and It has been Carci policy to continuously improve the quality of its products.
people. Carci reserves the right to make modifications on the design and its
a. The intensity of fields generated by fixed transmitters such as radio-base specifications, and also add to and improve its products, without being
stations for telephones (cellular / wireless) and land mobile radios, amateur
radios, AM, FM and TV radio-diffusion stations cannot be theoretically
liable for installing them in already manufactured products.
prognosticated with precision. To evaluate the electromagnetic environment
due to fixed RF transmitters, a study of the electromagnetic field at the location The text, illustrations and specifications contained in this manual are based
should be considered. If the intensity of the field measured at the location in on information available in print.
which SONOMED is used exceed the level of compliance above, the All rights reserved.
SONOMED should be observed to check if it is working normally. If abnormal
performance is noted, additional measures may be necessary, such as re- This manual cannot be reproduced in all or in part, without the written
instruction or relocation of the SONOMED; consent of Carci.
b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity should be
less than 3 V/m.
Manufacturer Data
Recommended separation distance between portable ad mobile RF
communication equipments and SONOMED
CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.
SONOMED is destined for use in electromagnetic environment where RF
CNPJ[Corporate Taxpayer’s Roll/Treasury Department] 61.461.034/0001-
disturbances are controlled. The SONOMED buyer or operator can help prevent
electromagnetic interference by keeping a minimum distance between portable and 78
mobile RF communication equipments (transmitters) and SONOMED as I.E. [State Registration] : 110.182.450.113
recommended below, according to the maximum output power of the Rua Álvares Fagundes, 359 – São Paulo – SP – Brazil – CEP [Zip Code]
communication equipment. 04338-000
Separation distance according to transmitter frequency Tel.: (0XX11) 3346 2100
Declared maximum 150 kHz to 80 80 MHz to 800 800 MHz to 2.5 email: carci@carci.com.br website: www.carci.com.br
output power of the MHz MHz GHz
transmitter (W)
d = 1.17. P d = 1.17. P d = 2 .3 . P Carci Registration in the Ministry of Health: MS-1.03.142-9
0.01 11.70 cm 11.7 0 cm 23.00 cm
0.1 37.00 cm 37.00 cm 72.70 cm For Technical Assistance:
1 1.17 m 1.17 m 2.30 m Technical Assistance Department
10 3.70 m 3.70 m 7.27 m Rua Álvares Fagundes, 359 – São Paulo – SP – Brazil – CEP 04338-000
100 11.70 m 11.70 m 23.00 m Tel.: (0XX11) 5621 7024 / 5622 8205
For transmitters with declared maximum output power not listed above, the email: sat@carci.com.br
MU_4150_ENG_Rev_04_092009 32 MU_4150_ENG_Rev_04_092009 33
 SONOMED V SONOMED V
4150 - 1&3 MHz 4150 - 1&3 MHz

• Touchstone J. C. e outers “Cortisol in human nerve” Science 142-1275

Technician In Charge: (1963).
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D
• Lehman J. F. e outers “The effect of ultrasound waves on the
permeability of biological membranes”. Strahienther, 79 (4) p.553
(1944).
EUROPEAN REPRESENTATIVE
• Patrick k. M. “Ultrasound in physiotherapy”, Ultrasonics. 4 p.p. 10 14
(1976).
OBELIS S.A.
34, Av. de Tervuren, bte 44 • Cyarlax j., “Textbook of orthopedic medicine”, vol. 1, Baltimore, William
B-1040 Brussels, BELGIUM & Wilkins (1975).
Tel: (32) 2.732.59.54
Fax: (32) 2.732.60.03 • J.F.Lehman, e outers “Pain threshold measurements after therapeutic
application of ultrasound, microwaves and infrared. Arch. phys. med.,
E-mail: mail@obelis.net 39, p 560 (1978).

Bibliographic References

• Lehman F. J. “Therapy with continuous wave ultrasound” in ultrasound

its applications in medicine and biology, ch. Ed. Francis J. Fry part. II,
Elsevier Publishing. Cop. 561 (1978).

• Santiesteban Joseph A. “Physical agents and musculoskeletal pain” in

orthopedic and sports phys. Therapy - Vol II, Ed. J. A. gold Mosby Co.
Toronto (1985).

• Lehman J. F. “Effects of therapeutic temperature on tendon

extensibility” arch. Phys. med. rehab. 51-481 (1970).

• Bearzy H. “Clinical application of ultrasonic energy in treatment of acute

and chronic subacromial bursitis”, arch. Phys., med. Rehab, 34-228
(1953).

• Griffin J. E. e outers “Ultrasonic movement of cortisol in pigtis sues II

peripheral nerve”, Am. J. Phys. Med. 41, 20 (1965).

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