MU_Sonomed_4150NC_ENG_CE2_Rev04_092009

Sonomed V 4150

User Manual

English

Revision : 06

SONOMED V 4150 - 1&3 MHz

MU_4150_ENG_Rev_04_092009 1

Tables of contents

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


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Presentation

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.

Accessories supplied with the device

SONOMED V 4150 01 Transductor 5 cm2

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

To buy optional accessories, please verify the codes at page 28, 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 : [email protected]


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General Information

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:

3 Mhz1 Mhz1cm

3cm9cm

Effective depth

Penetrating point3cm

Effective depth

Penetrating point


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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. 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.

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.


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Symbols Equipment symbols

Equipment off

Equipment on

This equipment has physiological effects. Consult instructions manual.

Applied part is type BF

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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Symbols on the pack

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:

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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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.

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

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)


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Ins ta l la t ion o f Transductor Suppor t

1 Step 2 Step Paste the adhesive in the acrylic Remove the protection cover According Picture below:

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

4 Step Fit the transductor in the Acrylic Support.

Acrylic Support

Adhesiveesivo

Protection cover

OR Left side esquerdo

Right side


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Display language

SONOMED allows three display languages to be accessed: Portuguese English Spanish

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

1. Connect the SONOMEDs 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 no problem

3. Next, press and hold the key

4. After the equipment emits a double beep, release the Protocols key.

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

6. Select the desired language through the keys

7. Press the key

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.

Protocols

Set


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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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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. Recommended intensity: 0.8 W/cm2 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. Recommended intensity: 1.0 W/cm2 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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f = 1 / T

T

50

%

Amplitude

T off

T on

Time

f = 1 / T

T T off

20 %

Amplitude

T on

Time

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. Recommended intensity: from 1.0 to 1.5 W/cm2 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 extra cell hemorrhage. Recommended intensity: 1.5 W/cm2 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 representat ion of Pulsed Mode


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f = 1 / T

T

10 %

Amplitude

T off

T on

Time

Work cycle: 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

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

f (frequency) = 1/T (period) Ton = active Time Toff = resting Time

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


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Pathology to be treated

ACUTEOR

CHRONIC

DESIRABLETHERMALEFFECT

ACUTE CHRONIC

UNDESIRABLETHERMALEFFECT

CONTINUOUSMODE

DEPTHTO BE

REACHED

MORETHEN1 cm

US1 MHz

US3 MHz

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

CHOOSE APPLICATION PARAMETERS

Start Therapy

PULSEDMODE

Yes No

FLOWCHART FOR ULTRASOUND THERAPY


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Controls

Cursor Movement Keys:


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Protocols Set WW/cm2 StopStart

Transductor :

Transductor Characteristics

reas indication Support position

SONOMED UHT 4100

1.0 /3.3 Mhz IPX7 Collimating

Era: 3,5 cm P.Max:7,2 W BNR


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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. Intensity: 0.0 to 2.0 W/cm2

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. Intensity: 0.0 to 3.0 W/cm2

5. Apply the gel on the area to be treated

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

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

8. Press the key

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.

StopStart

StopStart


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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:


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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 key to select the record mode.

The display will give the following screen

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

Protocols

PROTOCOLS

BACK SAVE USER FIX

1 2 3 4 5 6 7 8 9 0 a b c d e f g h i j k l m n o p q r s t u v w x y z , . Stp to DEL

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

PROTOCOLS FREQUENCY 1 MHz MODE CONTINUOUS FREQUENCY DUTY CYCLE TIMER INTENSITY 0 min 0,0 W/cm2


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Use the and keys to select the letter desired.

Press the key to write,

or the key to erase.

To record the protocols press the key:

This display shows the main screen

3. USERS The display will give the following Protocols recorded

Press the key to enable the Selected mode Users.

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

1 2 3 4 5 6 7 8 9 0 a b c d e f g h i j k l m n o p q r s t u v w x y z , . Stp to DEL

test rec

PROTOCOLS W TO DEL XXXXX YYYYY ZZZZZ

Protocols

PROTOCOLS TEST REC FREQUENCY 1 MHz MODE CONTINUOUS FREQUENCY DUTY CYCLE TIMER INTENSITY 10 min 1,0 W/cm2


MU_4150_ENG_Rev_04_092009 22

key.

The display will give the following screen :

For erase press the key, or the 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.

Use the keys to select the protocol desired, and Press the

key to enable the selected Protocol.

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)

Protocols

PROTOCOLS MAIN Hand Shoulder Elbow Hip Knee BURSITE

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


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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:

Injuries Neuritis Arthritis Distensions Adherences Sciatic Edemas Scars Bursitis Traumas


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Stiff necks Tenosinovitis Sacro-Iliac distension

Contra ind ica t ions 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

Correc t ive Main tenance PROBLEMS SOLUTIONS:

EQUIPMENT: DOES NOT TURN ON

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

DISPLAY INDICATES NO HEAD

CHECK IF THE TRANSDUCER POWER CABLE IS REALLY CONNECTED

IF AFFIRMATIVE AND IF THE ERROR INFORMATION PERSISTS, CONTACT THE TECHNICAL SUPPORT

PATIENT DISCOMFORT DUE TO TRANSDUCER

TEMPERATURE INCREASE

APPLY A LARGER QUANTITY OF GEL ON THE REGION UNDER TREATMENT.

APPLY THE ULTRASOUND IN SLOW, CIRCULAR AND CONTINUOUS MOVEMENTS

REDUCE OUTPUT INTENSITY DISPLAY INDICATES

ERROR HEAD CHECK IF THE TRANSDUCER POWER

CABLE IS REALLY CONNECTED IF AFFIRMATIVE AND IF THE ERROR


MU_4150_ENG_Rev_04_092009 25

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

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;


MU_4150_ENG_Rev_04_092009 26

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.

Technical specifications

Origin : CARCI Brazil Model :SONOMED V 4150 Function and application : ultrasound generating equipment for therapy. Electric supply : 100230 V~ automatic

( 10%) / 50 / 60 Hz Maximum consumption : 65 VA Fuses : 2.0A 250V 20AG Registro Anvisa : AM: 10314290018

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

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 Indication of output control : Intensity in W/Cm2


MU_4150_ENG_Rev_04_092009 27

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

Continuous mode : 7,2 W 20% Pulse mode : 10,5 W 20%

Maximum effective intensity : Continuous mode : 2 W/Cm2 Pulse mode : 3 W/Cm2

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 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

* SATP (Spatial Average Temporal Peak) Mean power value


MU_4150_ENG_Rev_04_092009 28

Head Appl icator ( t ransducer ) :

Type : Collimated Operating Frequency : 1 & 3 MHz 5% Aplicator area : 10 cm2 Geometric Area Transducer : 5 cm2 Effective Radiation Area (ERA) : 3.6cm2 20% Max. Intensity Ratio (BNR) : < 6.0 Water tightness : IPX7 Weight : 215 grams Maximum acoustic power : 10 Watts

Equipment operating conditions: Environmental temperature : +15C to +40C Relative humidity : 0% to 80% Atmospheric pressure : 700 hPa to 1060hPa

Environmental conditions for transport and storage: Environmental temperature : -10C to 50oC Relative humidity : 20% to 90% Atmospheric pressure : 500hPa to 1060hPa

Accessor ies:

Transdutor 5 cm2 , 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


MU_4150_ENG_Rev_04_092009 29

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 Compliance Electromagnetic environment - instruction

RF emission CISPR 11 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.

RF emission CISPR 11 Class B

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.

Harmonic emission IEC 61000-3-2 Class A

Voltage fluctuation / Flicker emission IEC 61000-3-3

Compliant

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 Level of IEC

60601 testing Level of

compliance Electromagnetic

environment - instruction

Electrostatic discharge

IEC 61000-4-2 6 kV contact

8 kV air 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 %.


MU_4150_ENG_Rev_04_092009 30

Immunity testing

Level of IEC 60601 testing

Level of compliance

Electromagnetic environment - instruction

Fast transient / Bursts IEC 61000-4-4

2 kV mains 1 kV in and out signal line

2 kV mains

Not applicable

The electric network quality should be that of a normal hospital or commercial environment.

Surge IEC 61000-4-5

1 kV differential mode 2 kV common mode

1 kV differential mode 2 kV common mode

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

95% drop in Ut) For 0.5 cycle

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


95% drop in Ut) For 5 s

95% drop in Ut) For 0.5 cycle



95% drop in Ut) For 5 s

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

3 A/m 3 A/m 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.


MU_4150_ENG_Rev_04_092009 31

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 Level of IEC

60601 testing

Level of compliance

Electromagnetic environment - instruction

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

3 V

3 V/m

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

Pd .17.1= 80 MHz to 800 MHz

Pd .3.2= 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 locationa, should be lesser than the level of compliance in each frequency range. b

Interference can occur around the equipment with the following


MU_4150_ENG_Rev_04_092009 32

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 re-instruction 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.

Declared maximum output power of the

transmitter (W)

Separation distance according to transmitter frequency 150 kHz to 80

MHz Pd .17.1=

80 MHz to 800 MHz

Pd .17.1=

800 MHz to 2.5 GHz

Pd .3.2= 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 33

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.

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] 61.461.034/0001-78 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 email: [email protected] website: www.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: [email protected]


MU_4150_ENG_Rev_04_092009 34

Technician In Charge: Orlando Orlandi Melo de Carvalho - CREA 5061377287/D

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: [email protected]

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 35

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).

Documents

MU_Sonomed_4150NC_ENG_CE2_Rev04_092009