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Sonomed III

Ref. 4134

Sonomed IV
Ref. 4144
User Manual

English

Revision : 06
Carci Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CNPJ 61.461.034/0001-78
Made in Brazil

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
Tables of contents

Presentation

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
10 .............Ultrasound energy
10 .............Ultrasound therapy
11 .............Continuous and Pulsed Mode
12 .............Cases where the Pulsed mode is advised
13..............Graphic representation of Pulsed Mode
15 .............Operational Flow Chart
16 .............Controls
17 .............Transductor
18 .............Appliance operation
21 .............Protocols
28 .............Indications
30 .............Contraindications
30 .............Corrective maintenance
31 .............Preventive maintenance and conservation
32 .............Precaution Instructions
33 .............Technical Specifications
36 .............Declarations
40 .............Final considerations
41 .............Bibliographical References

MU_4144_4134_ENG_Version_06

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

(01_2011)

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 III - 4134 and SONOMED IV 4144 devices were 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.

Accessories supplied with the device


SONOMED III 4134

01 Transductor 5 cm , freqncy: 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

SONOMED IV 4144

01 Transductor 5 cm , freqncy: 1,0 MHz


01 Acrylic Transductor Support
01 Adhesive for fixing the Support in the device
01 Tripolar Cable
01 Gel Tube 200ml
01 Users Manual

To buy optional accessories, please verify the codes at page 31,item:


Accessories.
If you have any doubt, please contact:
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

MU_4144_4134_ENG_Version_06

(01_2011)

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

General Information
The CARCI SONOMED IV 4144 and SONOMED III 4134 ultrasound were
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:

1 Mhz
Effec tive
depth
Penetrating
point

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.

3 Mhz
1cm
3cm

3cm

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.

Effec tive
depth
Penetrating
point

9cm

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).
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.

MU_4144_4134_ENG_Version_06

(01_2011)

MU_4144_4134_ENG_Version_06

(01_2011)

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Symbols

European representative

Equipment symbols
Symbols on the pack
Equipment off
Caution fragile. Handle with care
Equipment on
Keep in a dry place
This equipment has physiological effects.
Consult instructions manual.

Applied part is type BF

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.

Manufacturing date
Minimum and maximum temperature limits for
transport and storage.

Serial number

Manufacturer identification

Installation / Connection to mains supply


This symbol indicates that the head is
waterproof.

IPX7

Class II Equipment

CE Mark and certifying body identification

MU_4144_4134_ENG_Version_06

(01_2011)

For perfect operation of your equipment, we suggest that the electrical


installations comply with the following standards:
Brazil:
NBR 5410/1990 Low-voltage electrical installations;
NBR13534/1995 Electrical installations in health establishments
Safety requisites.

MU_4144_4134_ENG_Version_06

(01_2011)

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
Other countries:
IEC 60364-7-710/2002 Electrical installations medical
locations;
Or another listed standard applied in the country of use.

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
In s t a l l a t i o n o f T r a n s d u c to r S u p p o rt
1 Step

2 Step

Paste the adhesive in the acrylic


According Picture below

Remove the protection cover

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.

Protection cover

Connect the power cable to a three-pin connector located in the back


panel and connect it to the power supply socket
Acrylic Support

Adhesive

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

OR
Left side

Right side

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:

4 Step
Fit the transductor in the Acrylic Support.

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)

MU_4144_4134_ENG_Version_06

(01_2011)

MU_4144_4134_ENG_Version_06

(01_2011)

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Display language

Ultrasound Energy

SONOMED allows three display languages to be accessed:


Portuguese
English
Spanish

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.

In case you wish to change the current language, follow the steps below:
1.
2.
3.

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

Protocols
4.
5.

After the equipment emits a double beep, release the


Protocols key.
The display will show the accessible languages:
ENGLISH
PORTUGUESE
SPANISH

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.

6.

Select the desired language through the keys

7.

Press the key

8.

The equipment will exit the language selection mode, showing


the Main menu.

9.

Switch off the SONOMED.

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.

Set

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Ultrasound therapy

(01_2011)

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).

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

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).

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).

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.

Cases where Pulsed mode is advised

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.

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.

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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. 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 neural effect.
2
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-

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
absorption of extra cell hemorrhage. Recommended intensity: 1.5 W/cm
with treatment time of about 5 min.

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
2

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.

Amplitude
10%

T on

Graphic representation of Pulsed Mode

Time
T off
T

Amplitude

f= 1/T

T on

50 %

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
50%

Time
T off
T
f=1/T

f (frequency) = 1/T (period)


Ton = active Time
Toff = resting Time

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

T on

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

Time
T

T off

f=1/T

MU_4144_4134_ENG_Version_06

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

(01_2011)

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
Controls

FLOWCHART
THERAPY
FlowchartFOR
for ULTRASOUND
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

US
3 MHz

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

CHOOSE APPLICATION PARAMETERS

Start Therapy

Cursor Movement Keys:


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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Appliance operation
Protocols

W
W/cm 2

Set

Start
Stop

1.

Connect the transductor in Sonomed, according to Picture below :

1 MHz

4144

Transductor :
Transductor Characteristics

Serial
Number

3.3 MHz

Serial
Number

4134
2. Connect the Power cable in the Sonomed than in Power grid.

reas indication

MU_4144_4134_ENG_Version_06

Support position

(01_2011)

17

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18

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

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.
Timer

Intensity

Sonomed IV 4144
Mode

Freq

5. Select the Frequency or Duty Cycle parameters through the


keys.

Duty

CARCI S0001 Rev.3.2


SONOMED IV 1 MHz
Timer

To select the desired value use:

Intensity

6. With the

keys, select the Timer or Intensity parameters.

Sonomed III 4134


Mode

Freq

Duty

7. Use the

CARCI S0001 Rev.3.2


SONOMED III 1 MHz
Timer

keys to increase the Timer and Intensity values.

In continuous mode, the values that can be selected are:

Intensity

Note:

The S0001 indication refers to the series number of the Sonomed. The
same number is indicated on the sticker located under the device.

Mode: Continuous / Pulse


Timer: 0 to 20 min.
2
Intensity: 0.0 to 2.0 W/cm

In pulse mode:

Mode

Freq

Timer

Duty

Intensity

4. Select the Pulse or Continuous mode through the


Mode

Puls
00:00
MU_4144_4134_ENG_Version_06

Freq

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

8.

Apply the gel over the area to be treated.

9.

Position the transducer and press the


output circuit will be operated.

key and the

key.
10. At the end of treatment time , a double beep will sound and the output
circuit will be disabled.

Duty

16Hz
10%
0.0 W/Cm2
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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
11. Press the

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

key

Protocols
Atention
Before applying the treatment protocols the operator should be well
informed concerning the contents of this manual as well as on the operation
of this equipment and all aspects related with the treatment of the patient.

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.

B) Sonomed IV has around 9 treatment protocols suggestions and anables


Record 18 user protocols.
Below, a description of the protocols according to the application area and
patology , recorded in Sonomed III memory:

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)
A) Sonomed III has around 8 treatment protocols suggestions and anables
Record 18 user protocols.
Below, a description of the protocols according to the application area and
patology , recorded in Sonomed III memory:
In case you want to use the PROTOCOLS, press the key:
The display will give the following screen :

Mode

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MU_4144_4134_ENG_Version_06

Freq.

Protocols

Duty

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
Prot.
Back

Press the key


Timer

Use the keys

Freq.

to find the desired words.

W to DEL
C_ _ _ _ _ _ _

Intensity

Freq.

Duty

Use the keys

to change for the next word.

Prot.
User
Timer
Mode

W to DEL
CA_ _ _ _ _ _ _

Intensity
Freq.

W to DEL
_________

Duty

Use the keys

Mode

FIX

The display will give the following


screen :

Prot.
Save
Timer

USER

Set

Intensity

to select the desired PROTOCOL

Mode

SAVE

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Duty

After select the words you want to save

Prot.
Fix

W to DEL
CARCI_ _ _ _ _ _ _
Timer

Intensity

press the key

Save Protocols :
Select the option :

MU_4144_4134_ENG_Version_06

Prot.
Save

Set

to save in the protocol list.

The protocol will be saved in the memory and the display will show it in the
main screen.

(01_2011)

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

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

User Protocols :

Prot.
User

Select the option :

Press the key

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Deleting the Users Protocols :

Prot.
Usuario

Select the option :

Set
Press the key

Prot.
W to DEL
Carci 1 _ _ _ _ _ _ _

The display will give the following


screen :

Set

The display will give the following


screen :

Use the Keys

Prot.
W to DEL
Carci 1 _ _ _ _ _ _ _

to find the desired words.


Use the keys

Prot.
W to DEL
Carci 2_ _ _ _ _ _

Afer select the desired protocol, press the key


to enable the selected Protocol.

to find the desired words.

Prot.
W to DEL
Carci 2_ _ _ _ _ _

Set
Afer select the desired protocol, press the key
to delet the selected Protocol.

The display will give the recorded protocol:

Example Protocol Carci 1:

The display will give the following


screen :

Puls. 100Hz 50%


08:00
1.2 W/cm2

Apagar?
Carci2

Set = Yes
Prot=No

Apply the gel on the area to be treated


Position the transducer and press the key

Sta rt
cla
Stop

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Press the key


recorded.

Press the key

to delet, or the key

Set

Set

to keep it

Use the keys

to change to the select protocol mode:

Prot.
T. Ext

to return.

Use the keys

Fix Protocols :
Select the option :

Press the key

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Prot.
Fix

Use the keys

to find the desired protocols

Afer select the desired protocol, press the key


to enable the selected Protocol.
The display will show the recorded protocol
Exp: Hand Protocol Tendinits Extensor :

Set

The display will give the following


screen :

Hand

Prot.
Main
---------

Set

Prot.
T. Ext

Hand

Continuo
05:00
0.8 W/cm2

select the treatment desired area.


Apply the gel on the area to be treated

Prot.

Hand

Position the transducer and press the key

Sta rt
Stop

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

Prot.
Bursite

MU_4144_4134_ENG_Version_06

Shoulder
Indications of Ultrasound

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
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)


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

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Neuritis
Arthritis
Distensions
Adherences
Sciatic
Edemas
Scars
Bursitis
Traumas
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

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

Injuries

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SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
PROBLEMS

Preventive Maintenance and Conservation

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

EQUIPMENT TURNS ON,


BUT THE DISPLAY DO NOT
SHOW ANY INFORMATION

TURN OFF THE EQUIPMENT, WAIT A


FEW SECOUNDS AND TURN IT ON
AGAIN.
CONTACT THE TECHNICAL SUPPORT

EQUIPMENT:
DOES NOT TURN ON

DISPLAY INDICATES
NO HEAD

PATIENT DISCOMFORT
DUE TO TRANSDUCER

TEMPERATURE INCREASE

DISPLAY INDICATES
ERROR HEAD

MU_4144_4134_ENG_Version_06

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
INFORMATION PERSISTS, CONTACT
THE TECHNICAL SUPPORT

(01_2011)

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

31

We recommend that your SONOMED should be inspected and


calibrated once yearly

Use only water and soap for cleaning the transducer. Avoid using
alcohol except on the aluminum surface.

Use a wet cloth to clean the case of your appliance. Do not clean by
pulverization or immersion.

Be sure the appliance is disconnected from the main power supply


before cleaning it. Avoid wetting the electric power contacts of cables
and connectors

Control, with regularity, the power supply and the cable, certifying that
no defects are found.

Control, with regularity, the cable of the transducer, certifying that the
cable is not twisted or its insulation is damaged, that the connections of
the cable in the connectors are in perfect conditions and that there is no
gel accumulated on the side surface of the transducer.

The estimated useful life of the equipment is 5 years. After this period, it
is recommended for the equipment to be subjected to a full inspection
by CARCI in order to continue using it in a safe and efficient manner.

Do not dispose of this equipment or its accessories in the common bin


at the end of its useful life. There are substances in this equipment that
may be harmful to nature if not treated correctly. In the need to dispose
of the equipment or its accessories, hand over the material to CARCI,
which will handle it appropriately.

MU_4144_4134_ENG_Version_06

(01_2011)

32

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
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;

All Technical Support work for your appliance should be carried out by
properly Authorized and Qualified people;

Do not allow the transducer lid to heat excessively and repeatedly; and
do not cool it with cold water or ice so as not to damage the crystal;

Breakdowns of the transducer (head) can damage it completely;

The accessories described in this manual are intended for the exclusive
use of the equipment. The use of material different from the specified
one is under the responsibility of the user.

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.

Technical specifications

Origin
Model
SONOMED IV 4144
SONOMED III 4134
Function and application

Electric supply

Maximum consumption

MU_4144_4134_ENG_Version_06

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
Fuses
: 2.0A 250V 20AG
--------------------------------------------------------------------------------------------------- Classification of agreement with NBR 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
:
Sonomed IV = 1,0 MHz 5%
Sonomed III = 3,3 MHz 5%
Mode of Operation of U.S output
: Continuous and Pulsed
2
Indication of output control
: Intensity in W/Cm
: Power in W (SATP*)
Maximum effective output power
: 10W 10%
Maximum effective intensity
:
2
Continuous mode : 2 W/Cm
2
Pulsed 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
20% during 4ms pulses: time ratio 1:5

: CARCI Brazil
1.0 MHz
3,3 MHz
: ultrasound generating
equipment for therapy.
: 100230 V~ automatic
( 10%) / 50 / 60 Hz
: 65 VA

(01_2011)

33

Pulse frequency 16 Hz (20%)


Work cycle
10% during 6ms pulses: time ratio 1:9
20% during 12ms pulses: time ratio 1:5

Timer
Accuracy

MU_4144_4134_ENG_Version_06

:
:
:
:

1 to 20 min
1 to 5 min. 30 sec.
5 to 10 min. 10%
10 to 20 min. 1 min.

(01_2011)

34

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Size
(LxAxP) cm
: 30 x 11 x 20
Weight
: 1.2 Kg
Protection against risk of electric shock
: Class II
Degree of protection of applied part
: BF Type
Protection against water penetration
: IPX0
Mode of operation
: Continuous
UMDNS Classification
: 11-248

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

Relative humidity
Atmospheric pressure

: 0% to 80%
: 700 hPa to 1060hPa

Environmental conditions for transport and storage:


o
Environmental temperature
: -10C to 50 C
Relative humidity
: 20% to 90%
Atmospheric pressure
: 500hPa to 1060hPa

* SATP (Spatial Average Temporal Peak) Mean power value

Acc essories:

H e a d A p p l i c a t o r ( t ra n s d u c e r) :

SONOMED III 4134


2

Transdutor 5 cm , freqncy 3,3 MHz

Acrylic Transductor Support

Adhesive for fixing the Support in the device

Tripolar power cable

Gel Tube 200ml

Users manual

Code 22717G
Code 19343G
Code 19738G
Code 14747G
Code 7000/200
Code 17870G

SONOMED IV 4144
2

Transdutor 5 cm , freqncy 1,0 MHz

Acrylic Transductor Support

Adhesive for fixing the Support in the device

Tripolar power cable

Gel Tube 200ml

Users manual

Code 22716G
Code 19343G
Code 19738G
Code 14747G
Code 7000/200
Code 17870G

Model 4134
Type
Operating Frequency
Aplicator Area
Geometric Area transducer
Effective Radiation Area (ERA)
Max. Intensity Ratio (BNR)
Water tightness
Weight
Maximum acoustic power

: Collimated
: 3,3 MHz 5%
: 10 cm2
: 5 cm2
2
: 3.5cm 20%
: < 6.0 : 1
: IPX7
: 215 grams
: 10 Watts

Model 4144
Type
Operating Frequency
Aplicator Area
Geometric Area transducer
Effective Radiation Area (ERA)
Max. Intensity Ratio (BNR)
Water tightness
Weight
Maximum acoustic power

: Collimated
: 1,0 MHz 5%
: 10 cm2
: 5 cm2
: 3.5cm2 20%
: < 6.0 : 1
: IPX7
: 215 grams
: 10 Watts

Equipment operating conditions:


Environmental temperature

MU_4144_4134_ENG_Version_06

DECLARATION OF MANUFACTURER AND INSTRUCTION


ELECTROMAGNETIC EMISSIONS
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

RF emission
CISPR 11

Compliance

Electromagnetic environment instruction

Group 1

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.

: +15C to +40C

(01_2011)

35

MU_4144_4134_ENG_Version_06

(01_2011)

36

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
RF emission
CISPR 11
Harmonic emission
IEC 61000-3-2
Voltage fluctuation / Flicker
emission
IEC 61000-3-3

Class B
Class A
Compliant

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
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

Level of IEC
60601 testing

6 kV contact
8 kV air

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

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
synthetic material, the relative
humidity of air should be at
least 30 %.

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

Magnetic fields
of network
frequencies
(50/60 Hz)
IEC 61000-4-8

<5% Ut
(>95% drop in Ut)
For 0.5 cycle

<5% Ut
(>95% drop in
Ut)
For 0.5 cycle

40% Ut
(60% drop in Ut)
For 5 cycles

40% Ut
(60% drop in
Ut)
For 5 cycles

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

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

<5% Ut
(>95% drop in Ut)
For 5 s

<5% Ut
(>95% drop in
Ut)
For 5 s

3 A/m

3 A/m

The electric network quality


should be that of a normal
hospital
or
commercial
environment.

The magnetic fields of


network frequencies should be
the characteristic level of a
normal commercial or hospital
environment.

Note: Ut is the voltage of AC network before application of testing level.

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

MU_4144_4134_ENG_Version_06

Level of
compliance

Electromagnetic
environment - instruction

2 kV mains
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.

Not applicable
1 kV
differential
mode
2 kV common
mode

Immunity
testing

Level of IEC
60601 testing

Level of
compliance

Electromagnetic environment instruction


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

(01_2011)

37

MU_4144_4134_ENG_Version_06

(01_2011)

38

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
applicable for the transmitter frequency.
Recommended separation distance

Conducted
RF
IEC 610004-6

3 Vrms
150 kHz to 80
MHz

Radiated RF
IEC 610004-3

3 V/m
80 MHz to 2.5
GHz

d 1.17. P
d 1.17. P
3V

800 MHz

3 V/m

2.5 GHz

d 2.3. P

80 MHz to

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).

Interference can occur around the


equipment with the following symbol:

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.

(01_2011)

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.

800 MHz to

The field generated by fixed RF


transmitters, as determined by an
electromagnetic field study on the
locationa, should be lesser than the level
of compliance in each frequency range. b

MU_4144_4134_ENG_Version_06

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

39

Separation distance according to transmitter frequency


Declared maximum
output power of the
transmitter (W)

150 kHz to 80 MHz

d 1.17. P

80 MHz to 800
MHz

800 MHz to 2.5


GHz

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

1.17 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 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.

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.

MU_4144_4134_ENG_Version_06

(01_2011)

40

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz

This manual cannot be reproduced in all or in part, without the written


consent of Carci.

Lehman J. F. Effects of therapeutic temperature on tendon


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

Manufacturer Data
CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CNPJ
[Corporate
Taxpayers
Roll/Treasury
Department]
61.461.034/0001-78
I.E. [State Registration] : 110.182.450.113
Rua lvares Fagundes, 359 So Paulo SP Brazil CEP [Zip Code]
04338-000
Tel.: (11) 5621 2791
Fax.: (11) 5621 7024
email: carci@carci.com.br
website: www.carci.com.br

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).

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)

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.: (11) 5622 8205 / 5625 3104
email: sat@carci.com.br
Technician In Charge:
Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

Bibliographic References

WARRANTY CERTIFICATE IN ANNEX

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).

EUROPEAN REPRESENTATIVE

Santiesteban Joseph A. Physical agents and musculoskeletal pain in


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

MU_4144_4134_ENG_Version_06

(01_2011)

41

MU_4144_4134_ENG_Version_06

(01_2011)

42

SONOMED IV 4144 1 MHz


SONOMED III 4134 3 MHz
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

MU_4144_4134_ENG_Version_06

(01_2011)

43

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