SONOMED V

4150 - 1&3 MHz

Tables of contents

Sonomed V
4150

User Manual

02 ............. Presentation
02 .............Accessories supplied with the device
03 .............General Information
05 .............Symbols
06 .............Installation / Connection to mains supply
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
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
MU_4150_ENG_Rev_04_092009

SONOMED V
4150 - 1&3 MHz

SONOMED V
4150 - 1&3 MHz

Presentation

General Information

Carci is proud to congratulate you for the acquisition of a high technology

and security equipment. Where we are sure this equipment will satisfy the
highest quality standards.
SONOMED V 4150 device was designed according to IEC 60601.1:1994
+ amend 1:1997, IEC 60601-1-2:2006 and IEC 60601-2-5:1997 safety
rules, which makes them a safe and reliable product.

The Ultrasound CARCI SONOMED V was developed with the purpose of providing
the essential support that the ultrasound technology allows to the clinical
physiotherapy practice.
The Ultrasound is a mechanical stimulus directed to the body through ultrasonic
beam emitted by a transducer / applicator, better known as head. This Ultrasound is
produced in the head through a piezo-electric crystal and transmitted to the body
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
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
and an increase in the restoration rate of delicate tissues. The higher the frequency
of the Ultrasound, the more superficial its absorption will be, as it may be seen in the
figure below:

Accessories supplied with the device

SONOMED V 4150

01 Transductor 5 cm
freqncy: 1,0 and 3,3 MHz
01 Acrylic Transductor Support
01 Adhesive for fixing the Support in the device
01 Tripolar Cable
01 Gel Tube 200ml
01 Users manual

1 Mhz
Effec tive
depth

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

Penetrating
point

3 Mhz
1c m
3c m

3c m

Effective
depth
Penetrating
point

9c m

Technical Assistance Department

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

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SONOMED V
4150 - 1&3 MHz
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
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.

SONOMED V
4150 - 1&3 MHz
Symbols
Equipment symbols
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
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
area) and BNR (non-uniformity relation of the ultrasound beam) were determined.

Equipment on
This equipment has physiological effects.
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
great accuracy in the values of intensity scale (dosages).

Applied part is type BF

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
in an intimate understanding of the possibilities and limitations of Ultrasound
therapy.

Manufacturing date
Serial number
Manufacturer identification

IPX7

This symbol indicates that the head is waterproof.

IPX0

This symbol indicates that the equipment isnt

waterproof.
Class II Equipment

CE Mark and certifying body identification

European representative

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SONOMED V
4150 - 1&3 MHz

SONOMED V
4150 - 1&3 MHz
The electric power supplys voltage must be within the range specified in the
Technical Features, otherwise, there can be reduced equipment performance
and safety risk.

Symbols on the pack

Connect the power cable to a three-pin connector located in the back panel
and connect it to the power supply socket

Caution fragile. Handle with care

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.

Installation / Connection to mains supply

For perfect operation of your equipment, we suggest that the electrical installations
comply with the following standards:

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
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
counterclockwise direction)

 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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SONOMED V
4150 - 1&3 MHz

SONOMED V
4150 - 1&3 MHz

Installation of Transductor Support

Display language

1 Step
Paste the adhesive in the acrylic
According Picture below:

SONOMED allows three display languages to be accessed:

 Portuguese
 English
 Spanish

2 Step
Remove the protection cover

Protection cover

In case you wish to change the current language, follow the steps below:
1.
2.

Acrylic Support

Adhesive
esivo

3.

3 Step
Choose the side and paste the Acrylic support in the device, according to Picture
below:

Protocols

6.

After the equipment emits a double beep, release the

Protocols key.
The display will show the accessible languages:
ENGLISH
PORTUGUESE
SPANISH
Select the desired language through the keys

7.

Press the key

8.

Switch off the SONOMED.

4.
5.

OR
Left side
esquerdo

Connect the SONOMEDs power cable to the electric network.

Switch on the device the equipment will test the display and
processor circuit, and will emit a double beep in case there is
no problem
Next, press and hold the key

Right side

4 Step
Fit the transductor in the Acrylic Support.

Set

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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SONOMED V
4150 - 1&3 MHz
Continuous and Pulsed Mode

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 nonsimilar 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 (antiinflammatory 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

10

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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SONOMED V
4150 - 1&3 MHz
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
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
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
longitudinal axle of the muscle.

Graphic representation of Pulsed Mode

SONOMED V
4150 - 1&3 MHz

Amplitude
10 %

T on

Time
T off
T
f=1/T

Amplitude

Work cycle:
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
Relation Ton/Toff
1:2
1:5
1:9

T on

50 %

50%

Time
T off
T

f (frequency) = 1/T (period)

Ton = active Time
Toff = resting Time

f=1/T

Amplitude

20%

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 %
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
16 Hz with work cycle of 10 % or 20 %
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

T on

Time
T

T off

f=1/T

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13

SONOMED V
4150 - 1&3 MHz

SONOMED V
4150 - 1&3 MHz
C o n t r ol s

FLOWCHART FOR ULTRASOUND THERAPY

Pathology to be treated

ACUTE
OR
CHRONIC

ACUTE

CHRONIC

DESIRABLE
THERMAL
EFFECT

UNDESIRABLE
THERMAL
EFFECT

DEPTH
TO BE
REACHED

CONTINUOUS
MODE

US
1 MHz

Yes

MORE
THEN
1 cm

PULSED
MODE

No

Cursor Movement Keys:

US
3 MHz

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

CHOOSE APPLICATION PARAMETERS

Start Therapy

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15

SONOMED V
4150 - 1&3 MHz

SONOMED V
4150 - 1&3 MHz
Appliance operation

Protocols

Set

W
2
W/cm

Sta rt
Stop

1.

Connect the transductor in Sonomed, according to Picture below :

1.0/ 3.3 MHz

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

Transductor Characteristics

3. Turn on the appliance the equipment will perform a test of the display
and the circuit of the processor and will issue a double beep in case it is
failure free

SONOMED UHT 4100

1.0 /3.3 Mhz IPX7 Collimating
Era: 3,5 cm P.Max:7,2 W
BNR<6:1 S/N: 4150zzzz

reas indication

4. Select through the keys

the wanted parameters:

Support position

For selecting the wanted Value use:

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17

SONOMED V
4150 - 1&3 MHz
The values that can be selected in the continuous mode are as follows:


Frequency 1 / 3 MHz


Mode: Continuous / Pulsed


Timer: 0 to 20 min.
2


Intensity: 0.0 to 2.0 W/cm
In the Pulsed mode:
Frequency 1 / 3 MHz
Modulation frequency: 16/48 or 100 Hz
Work cycle: 10 / 20 or 50%* *(Only for 100Hz)
Timer: 0 to 20 min.
2
Intensity: 0.0 to 3.0 W/cm

5. Apply the gel on the area to be treated

6. Position the transducer and press the key
circuit will be turned on.

Sta rt
Stop

and the output

SONOMED V
4150 - 1&3 MHz
Limitations of Liability
In no case Carci Ind. e Com. e Com., or its suppliers and / or distributors,
are liable by any indirect, special, incidental damage caused by the use or
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
the legal or equitable theory (contract, appeal or another mode) on which
the claim is based.
Carci cannot be held responsible for any consequence resulting from
incorrect information provided by its staff, or errors included in this manual
and / or another attached documentation (including commercial
documentation)
Sonomed V has around 15 treatment protocols suggestions and enables
record 18 user protocols.
Below, a description of the protocols according to the application area, for
the frequencies: 1MHz and 3.3 MHz, recorded in Sonomed V memory:

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

Sta rt
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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19

SONOMED V
4150 - 1&3 MHz
In case you want to use the PROTOCOLS, press the key
 The display will give the
Following screen :

Use the
keys to
select the desired PROTOCOL.
1. BACK  Go back to the main
screen .
Press the

key to Return.

2.SAVE  Record the protocol in the

memory.

Press the

Protocols
Use the
and
to select the letter desired.

keys

PROTOCOLS
BACK
SAVE
USER
FIX

Press the

or the key

6
f
p
z

7
g
q

8
h
r
,

9 0
i j
s t
.

to erase.

To record the protocols press the key:

PROTOCOLS
FREQUENCY
MODE
FREQUENCY
DUTY CYCLE
TIMER
0 min

1 2 3 4 5
a b c d e
k l mn o
u v wx y
Stp to DEL

key to write,

1 2 3 4 5
a b c d e
k l mn o
u v wx y
Stp to DEL
test rec

Protocols

1 MHz
CONTINUOUS

INTENSITY
0,0 W/cm2

key to select the record mode.

The display will give the following

screen

SONOMED V
4150 - 1&3 MHz

This display shows the main screen

PROTOCOLS
FREQUENCY
MODE
FREQUENCY
DUTY CYCLE
TIMER
10 min

TEST REC
1 MHz
CONTINUOUS

INTENSITY
1,0 W/cm2

3. USERS  The display will give the following Protocols recorded

6
f
p
z

7
g
q

8
h
r
,

9 0
i j
s t
.

Press the
key to enable the
Selected mode Users.

PROTOCOLS
XXXXX
YYYYY
ZZZZZ

W TO DEL

-------------OBS.: If the parameters timer and intensity are in blanck it will not be
possible to save

Use the

keys to select the Protocol desired, and Press the

key to enable the selected Protocol.

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

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21

SONOMED V
4150 - 1&3 MHz
key.
The display will give the following
screen :

For erase press the

key, or the

PROTOCOLOS
STP TO DEL
XXXXX
YYYYY
ZZZZZ
DELETE ?
SET = YES
PROTOC = NO

Protocols

to keep.

To return to main screen, you must to select a Protocol and press

key
4. FIX  The display will give the
following Sonomed Protocols.

PROTOCOLS
MAIN
Hand
Shoulder
Elbow
Hip
Knee

BURSITE

Use the

keys to select the protocol desired, and Press the

Bursitis
Causalgias
Coccygodynias
Neuritis
Intercostal neuralgia
Osteitis
Chronic Periarteritis
Reynauds Disease
Herpes Zoster
Mialgias
Intermittent claudication
Mielitis
Prostatitis
Radiculitis
Sciatic
Front Sinusitis
Maxillary Sinusitis
Escalenos Syndrome
Tenovaginitis
Veined Stasis Ulcer.
Lumbago
Different rheumatisms
Sudecks Atrophy

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

Indications of Ultrasound
The indications presented by the literature are based on biophysics
researches, which in most of the cases coincide with those originating from
the empiricism developed by the clinical practice. These indications are
based fundamentally on the capacity of the ultrasound in selectively heating
the tissues.
The ultrasound has been used successfully as joint therapy in the following
general cases:
Arthrosis (large and small articulations)
MU_4150_ENG_Rev_04_092009

key to enable the selected Protocol.

SONOMED V
4150 - 1&3 MHz

22

Injuries
Neuritis
Arthritis
Distensions
Adherences
Sciatic
Edemas
Scars
Bursitis
Traumas
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SONOMED V
4150 - 1&3 MHz

Stiff necks
Tenosinovitis
Sacro-Iliac distension

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

INFORMATION PERSISTS, CONTACT THE

TECHNICAL SUPPORT
OBS.: esquemas Eltricos, circuitos e listas de peas no so fornecidos a
consumidores finais. Em caso de necessidade contate a Assistncia Tcnica
Autorizada CARCI

Contraindications

Preventive Maintenance and Conservation




Corrective Maintenance
PROBLEMS
EQUIPMENT:
DOES NOT TURN ON
EQUIPMENT TURNS ON, BUT
THE DISPLAY DO NOT SHOW
ANY INFORMATION
DISPLAY INDICATES
NO HEAD

DISPLAY INDICATES
ERROR HEAD


SOLUTIONS:

PATIENT DISCOMFORT DUE

TO TRANSDUCER
TEMPERATURE INCREASE

SONOMED V
4150 - 1&3 MHz

MU_4150_ENG_Rev_04_092009

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

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;

MU_4150_ENG_Rev_04_092009

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SONOMED V
4150 - 1&3 MHz

All Technical Support work for your appliance should be carried out by properly
Authorized and Qualified people;
Do not permit the lid of the transducer to heat excessively and repeatedly; and
do not cool the same with icy water or ice to not damage the crystal;
Falls of the transductor (head) can damage it completely or change the output
parameters. Handle the transductor with care;
Do not dispose this equipment or accessories in the ordinary trash, at the end
of its useful life. There are substances in the equipment that can be harmful to
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
treatment.
This equipment does not have protection against water penetration (IPX0). In
the case of accidental water penetration inside the equipment, do not

connect it to the electric network and send it over to technical

assistance to check for any damage that may have occurred.

Origin
Model
Function and application

Electric supply

Maximum consumption
Fuses
Registro Anvisa

: Power in W (SATP*)
Maximum effective output power

Continuous mode : 7,2 W 20%

Pulse mode : 10,5 W 20%

Maximum effective intensity
:
2

Continuous mode : 2 W/Cm

2

Pulse mode : 3 W/Cm

Modulation in pulse mode (square wave):

Pulse frequency 100 Hz (20%)

Work cycle
10% during 1ms pulses: time ratio 1:9
20% during 2ms pulses: time ratio 1:5
50% during 5ms pulses: time ratio 1:2

Pulse frequency 48 Hz (20%)

Work cycle
10% during 2ms pulses: time ratio 1:9

Pulse frequency 16 Hz (20%)

Work cycle
10% during 6ms pulses: time ratio 1:9
20% during 12ms pulses: time ratio 1:5
Timer
: 1 to 20 min
Accuracy
: 1 to 5 min. 30 sec.
: 5 to 10 min. 10%
: 10 to 20 min. 1 min.
Size
(LxAxP) cm: 30 x 11 x 20
Weight
: 1.2 Kg

20% during 4ms pulses: time ratio 1:5

Technical specifications

SONOMED V
4150 - 1&3 MHz

: CARCI Brazil
:SONOMED V 4150
: ultrasound generating
equipment for therapy.
: 100230 V~ automatic
( 10%) / 50 / 60 Hz
: 65 VA
: 2.0A 250V 20AG
: 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
Mode of Operation of U.S output
Indication of output control

MU_4150_ENG_Rev_04_092009

: 1,0 & 3.3 MHz 5%

: Continuous and Pulse
2
: Intensity in W/Cm

26

MU_4150_ENG_Rev_04_092009

27

SONOMED V
4150 - 1&3 MHz

SONOMED V
4150 - 1&3 MHz

H e a d Ap p l i c a t o r ( t r a n s d u c e r ) :
Type
Operating Frequency
Aplicator area
Geometric Area Transducer
Effective Radiation Area (ERA)
Max. Intensity Ratio (BNR)
Water tightness
Weight
Maximum acoustic power

Equipment operating conditions:

Environmental temperature

Relative humidity

Atmospheric pressure

: 5 cm

: < 6.0

: Collimated
: 1 & 3 MHz 5%
2
: 10 cm
2

: 3.6cm 20%
: IPX7
: 215 grams
: 10 Watts

RF emission
CISPR 11

: +15C to +40C
: 0% to 80%
: 700 hPa to 1060hPa

Class B
Class A
Compliant

Electromagnetic environment
- instruction
SONOMED uses RF power only
for its internal functioning.
Therefore, its RF emission is
very low and does not probably
cause any interference in other
close by electronic equipment.
SONOMED is destined for use
in all establishments, including
domestic and those directly
connected to the public electric
network that supplies power to
buildings
with
domestic
purposes.

DECLARATION OF MANUFACTURER AND INSTRUCTION

ELECTROMAGNETIC IMMUNITY

Transdutor 5 cm , freqncy 1,0 and 3,3 MHz

Code 17666G

Acrylic Transductor Support

Code 19343G

Adhesive for fixing the Support in the device

Code 19738G

Tripolar Cable

Code 14747G

Gel Tube 200ml

Code 7000/200

User manual

Code MU4150

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
environment.
Immunity
testing

Electrostatic
discharge
IEC 61000-4-2

MU_4150_ENG_Rev_04_092009

Compliance

Group 1

RF emission
CISPR 11
Harmonic emission
IEC 61000-3-2
Voltage fluctuation /
Flicker emission
IEC 61000-3-3

Accessories:

SONOMED is destined for use in electromagnetic environment described below.

The SONOMED buyer or operator should ensure that it is in use in such
environment.
Emission testing

Environmental conditions for transport and storage:

o

Environmental temperature
: -10C to 50 C

Relative humidity
: 20% to 90%
Atmospheric pressure
: 500hPa to 1060hPa

DECLARATION OF MANUFACTURER AND INSTRUCTION

ELECTROMAGNETIC EMISSIONS

28

Level of IEC
60601 testing

6 kV contact
8 kV air

MU_4150_ENG_Rev_04_092009

Level of
compliance

Electromagnetic
environment - instruction

6 kV contact
8 kV air

The
floor
should
be
wooden,
concrete
or
ceramic. If the floor is
covered
with
a
shumidiynthetic
material,
the relative ty of air should
be at least 30 %.

29

SONOMED V
4150 - 1&3 MHz
Immunity
testing

Level of IEC
60601 testing

Fast transient /
Bursts
IEC 61000-4-4

2 kV mains
1 kV in and out
signal line

Surge
IEC 61000-4-5

1
kV
differential mode
2 kV common
mode
<5% Ut
(>95% drop in
Ut)
For 0.5 cycle

Voltage
drop,
short
cut-offs
and
voltage
variations
in
electric power
supply.
IEC 61000-4-11

40% Ut
(60% drop in Ut)
For 5 cycles
70% Ut
(30% drop in Ut)
For 25 cycles
<5% Ut
(>95% drop in
Ut)
For 5 s

Level of
compliance

Electromagnetic
environment - instruction

2 kV mains
Not applicable

1
kV
differential
mode

2
kV
common
mode
<5% Ut
(>95% drop in
Ut)
For 0.5 cycle
40% Ut
(60% drop in
Ut)
For 5 cycles

The electric network quality

should be that of a normal
hospital or commercial
environment.

70% Ut
(30% drop in
Ut)
For 25 cycles

SONOMED V
4150 - 1&3 MHz
DECLARATION OF MANUFACTURER AND INSTRUCTION
ELECTROMAGNETIC IMMUNITY
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
environment.
Level of IEC
Immunity
Level of
Electromagnetic environment 60601
testing
compliance
instruction
testing
Portable
and
mobile
RF
communication equipment should
not be used closer to any
SONOMED part, including cables,
than the recommended separation
distance calculated from the
equation
applicable
for
the
transmitter frequency.
Recommended separation distance
3 Vrms
Conducted
3V
RF
150 kHz to 80
80 MHz to 800
d = 1.17. P
IEC 61000- MHz
MHz
4-6
Radiated
RF
IEC 610004-3

<5% Ut
(>95% drop in
Ut)
For 5 s
3 A/m

3 V/m
80 MHz to 2.5
GHz

3 V/m

Magnetic fields 3 A/m

The magnetic fields of
of
network
network frequencies should
frequencies
be the characteristic level of
(50/60 Hz)
a normal commercial or
IEC 61000-4-8
hospital environment.
Note: Ut is the voltage of AC network before application of testing level.

d = 2 .3 . P

800 MHz to 2.5

GHz

Where P is the maximum output

power of the transmitter in watts
(W), according to the transmitter
manufacturer, and d is the
recommended separation distance
in meters (m).
The field generated by fixed RF
transmitters, as determined by an
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
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.
NOTE 2: this procedure may not apply to all the situations. The electromagnetic
propagation is affected by absorption and reflection of structures, objects and
people.
a. The intensity of fields generated by fixed transmitters such as radio-base
stations for telephones (cellular / wireless) and land mobile radios, amateur
radios, AM, FM and TV radio-diffusion stations cannot be theoretically
prognosticated with precision. To evaluate the electromagnetic environment
due to fixed RF transmitters, a study of the electromagnetic field at the location
should be considered. If the intensity of the field measured at the location in
which SONOMED is used exceed the level of compliance above, the
SONOMED should be observed to check if it is working normally. If abnormal
performance is noted, additional measures may be necessary, such as reinstruction or relocation of the SONOMED;
b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity should be
less than 3 V/m.
Recommended separation distance between portable ad mobile RF
communication equipments and SONOMED
SONOMED is destined for use in electromagnetic environment where RF
disturbances are controlled. The SONOMED buyer or operator can help prevent
electromagnetic interference by keeping a minimum distance between portable and
mobile RF communication equipments (transmitters) and SONOMED as
recommended below, according to the maximum output power of the
communication equipment.
Separation distance according to transmitter frequency
Declared maximum
800 MHz to 2.5
150 kHz to 80
80 MHz to 800
output power of the
GHz
MHz
MHz
transmitter (W)

d = 1.17. P

d = 1.17. P

d = 2 .3 . P

0.01
11.70 cm
11.7 0 cm
23.00 cm
0.1
37.00 cm
37.00 cm
72.70 cm
1
1.17 m
1.17 m
2.30 m
10
3.70 m
3.70 m
7.27 m
100
11.70 m
11.70 m
23.00 m
For transmitters with declared maximum output power not listed above, the

MU_4150_ENG_Rev_04_092009

SONOMED V
4150 - 1&3 MHz

32

Final considerations
It has been Carci policy to continuously improve the quality of its products.
Carci reserves the right to make modifications on the design and its
specifications, and also add to and improve its products, without being
liable for installing them in already manufactured products.
The text, illustrations and specifications contained in this manual are based
on information available in print.
All rights reserved.
This manual cannot be reproduced in all or in part, without the written
consent of Carci.
Manufacturer Data
CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CNPJ[Corporate Taxpayers Roll/Treasury Department] 61.461.034/000178
I.E. [State Registration] : 110.182.450.113
Rua lvares Fagundes, 359 So Paulo SP Brazil CEP [Zip Code]
04338-000
Tel.: (0XX11) 3346 2100
website: www.carci.com.br
email: carci@carci.com.br
Carci Registration in the Ministry of Health: MS-1.03.142-9
For Technical Assistance:
Technical Assistance Department
Rua lvares Fagundes, 359 So Paulo SP Brazil CEP 04338-000
Tel.: (0XX11) 5621 7024 / 5622 8205
email: sat@carci.com.br
MU_4150_ENG_Rev_04_092009
33

SONOMED V
4150 - 1&3 MHz
Technician In Charge:
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

SONOMED V
4150 - 1&3 MHz

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

(1963).

Lehman J. F. e outers The effect of ultrasound waves on the

permeability of biological membranes. Strahienther, 79 (4) p.553
(1944).

Patrick k. M. Ultrasound in physiotherapy, Ultrasonics. 4 p.p. 10 14

(1976).

Cyarlax j., Textbook of orthopedic medicine, vol. 1, Baltimore, William

& Wilkins (1975).

J.F.Lehman, e outers Pain threshold measurements after therapeutic

application of ultrasound, microwaves and infrared. Arch. phys. med.,
39, p 560 (1978).

EUROPEAN REPRESENTATIVE

OBELIS S.A.
34, Av. de Tervuren, bte 44
B-1040 Brussels, BELGIUM
Tel: (32) 2.732.59.54
Fax: (32) 2.732.60.03
E-mail: mail@obelis.net

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).
MU_4150_ENG_Rev_04_092009

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MU_4150_ENG_Rev_04_092009

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