Sonomed III Ref. 4134
Sonomed IV Ref. 4144
User Manual
English
Revision : 06 Carci Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda. CNPJ 61.461.034/0001-78 Made in Brazil
SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz Tables of contents
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.
02 .............Presentation 02 .............Accessories supplied with the device 03 .............General Information Information 05 .............Sym .... .........Symbols bols 06 .............Installation / Connection to mains supply 08 .............Installation of Transductor Support 09 .............Display Language 10 .............Ultrasound energy 10 .............Ultrasound .... .........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 .............Control .... .........Controlss 17 .............Transductor .............Transductor 18 .............Appliance operation 21 .............Protocols 28 .............Indications .... .........Indications 30 .............Contraindications .............Contraindications 30 .............Correctiv .... .........Corrective e maintenance 31 .............Preventive maintenance and conservation 32 .............Precaution .... .........Precaution Instructions 33 .............Technical .... .........Technical Specifications 36 .............Declarations 40 .............Final co nsiderations 41 .............Bibliographical .... .........Bibliographical References
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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 safe and reliable product.
Accessories supplied with the device SONOMED III 4134
01 Transductor 5 cm2 , freqüêncy: freqüêncy: 3,3 MHz 01 Acrylic Transductor Support 01 Adhesive Adhesive for fixing fixing the Support in the device 01 Tripolar Cable 01 Gel Tube – 200ml 200ml 01 User’s Manual
SONOMED IV 4144
01 Transductor 5 cm2 , freqüêncy: freqüêncy: 1,0 MHz 01 Acrylic Transductor Support 01 Adhesive Adhesive for fixing fixing the Support in the device 01 Tripolar Cable 01 Gel Tube – 200ml 200ml 01 User’s Manual
To buy optional accessories, please verify t he codes at page 31,item: Accessories. If you have any doubt, please contact: Technical Assistance Department Rua Álvares Fagundes, 359 – Americanópolis São Paulo – SP – Brasil -CEP 04338-000 Tel.: (0XX11) 5621 7024 / 5622 8205 e-mail :
[email protected]
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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 t ransducer / 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 Effective 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.
Effective 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.
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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.
This side up. This symbol i ndicates the right transport position
Applied part is type BF
Maximum piling. Indicates the maximum number of boxes that can be piled. The quantity is marked in the i ntermediary 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
For perfect operation of your equipment, we suggest that the electrical installations comply with the following standards: Brazil:
CE Mark and certifying body identification
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NBR 5410/1990 – Low-voltage electrical installations; NBR13534/1995 – Electrical installations in health health establishments establishments – Safety requisites.
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SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
Installation of Transductor Support
Other countries:
SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
IEC 60364-7-710/2002 – Electrical installations – medical locations; Or another another listed standard applied in the country of use. use.
1° Step
2° Step
Paste the adhesive in the acrylic According Picture below
Remove the protection cover
The electric power supply’s voltage must be within the range specified in the Technical Features, otherwise, there can be reduced equipment performance and safety risk.
Protection cover
Connect the power power cable cable to a three-pin three-pin connector 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 uses switched switched power supply and operates 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:
4º 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 t he counterclockwise direction)
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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:
It is a f orm 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 i n-depth heating of tissues.
Portuguese English
Spanish
In case you wi sh to change the current language, follow the steps below: 1. 2. 3.
Connect the SONOMED’s 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.
After the equipment emits a double beep, release the key. The display will show the accessible languages: ENGLISH PORTUGUESE SPANISH Protocols
5.
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.
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.
Set
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Ultrasound therapy
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• 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 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 conditi ons 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. 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 i s 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
SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
absorption of extra cell hemorrhage. Recommended intensity: 1.5 W/cm 2 with treatment time of about 5 min.
Amplitude
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.
10% 10%
T on
Graphic representation of Pulsed Mode
Time T off
T
Amplitude
f=1/T
ork 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 %
50%
Time T off
T f=1/T
f (frequency) = 1/T (period) active Time Toff = resting Time Ton =
Amplitude
20% 20%
100Hz with work cycle of 10 %, 20 % or 50 % That is for 10 % 1 ms active time and 9ms 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 18ms rest rest – 1:9 ratio ratio 20 % 4 ms active time and 16ms rest – 1:5 ratio
Time T
T off
16 Hz with work cycle of 10 % or 20 % This is for 10 % 6 ms active time and 56ms 56ms rest – 1:9 ratio 20 % 12 ms active time and 50ms rest – 1:5 ratio
f=1/T
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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
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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 2 W/cm
Set
Start Stop
1.
Connect the transductor in Sonomed, according to Picture Picture below :
1 MHz
4144
Transductor : Transductor Characteristics
Serial Number
3.3 MHz
Serial Number
4134 2. Connect the Power Power cable in the Sonomed Sonomed than in Power grid.
Áreas indication MU_4144_4134_ENG_V MU_4144_4134_ENG_Version_06 ersion_06
Support position (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
3. Turn on the appliance – the the equipment will will perform a test of the display and the circuit of the processor and will issue a double beep in case it i s failure free. Timer
Sonomed IV 4144 Mode
Freq
5. Select the Frequency or Duty Cycle parameters through through the keys.
Duty
CARCI S0001 Rev.3.2 SONOMED IV 1 MHz Timer
Intensity
To select the desired value use:
Intensity
6. With the
keys, select the Timer or Intensity parameters.
Sonomed III 4134 Mode
Freq
Duty
CARCI S0001 Rev.3.2 SONOMED III 1 MHz Timer
7. Use the
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. Intensity: 0.0 to 2.0 W/cm2
In pulse mode:
Mode
Freq
Timer
Duty
Intensity
4. Select the Pulse or Continuous mode through the Mode
Freq
Apply the gel gel over over the area to be treated.
9.
Position the transducer and press the output circuit will be operated.
key and the
10. At the end of treatment time , a double beep will sound and the output circuit will be disabled.
Duty
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key.
Puls 16Hz 10% 00:00 0.0 W/Cm2 MU_4144_4134_ENG_V MU_4144_4134_ENG_Version_06 ersion_06
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/cm 2
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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 protocols suggestions and 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 f ollowing screen :
Mode
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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 save
Prot. Fix
W to DEL CARCI _ _ _ _ _ _ _ _ Timer
Intensity
press the key
Save Protocols : Select the option :
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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.
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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 User’s Protocols :
Prot. Usuario
Select the option : Set
The display will give the following screen :
Use the Keys
Press the key
Prot. W to DEL Carci 1 _ _ _ _ _ _ _
The display will give the following screen :
Prot. Carci 1
W to DEL
to find the desired words. Use the keys
Prot. W to DEL Carci 2_ _ _ _ _ _ Afer select the desired protocol, press press the key to enable the selected P rotocol.
to find the desired words.
Prot. W to DEL Carci 2_ _ _ _ _ _
Set
Afer select the desired protocol, press press the key to delet the selected Protocol.
The display will give the recorded protocol:
Example Protocol Carci 1:
Set
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 treated Position the transducer and press the key
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Start cla Stop
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SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
Press the key recorded.
Press the key
Set
Set
to delet, or the key
to keep it
to change to the select protocol mode:
Prot. T. Ext Use the keys
Select the option :
Prot. Fix
Hand
to find the desired protocols
Afer select the desired protocol, press press the key to enable the selected P rotocol. The display will show t he recorded protocol Exp: Hand Protocol Tendinits Extensor :
Set
The display will give the following screen :
Use the keys
Use the keys
to return.
Fix Protocols :
Press the key
SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
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 treated
Prot.
Hand
Position the transducer and press the k ey
Start Stop
Upon ending up the treatment a double beep will sound and the output circuit will be disabled.
Prot. Shoulder Bursite
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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 Reynaud’s Disease Herpes Zoster Mialgias Intermittent claudication Mielitis Prostatitis Radiculitis Sciatic Front Sinusitis Maxillary Sinusitis Escaleno’s Syndrome Tenovaginitis Veined Stasis Ulcer. Lumbago Different rheumatisms Sudeck’s 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 t reatment by ultrasound as adjuvant therapeutic agent: Injuries
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SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz PROBLEMS
EQUIPMENT: DOES NOT TURN ON
EQUIPMENT TURNS ON, BUT THE DISPLAY DO NOT SHOW ANY INFORMATION
DISPLAY INDICATES NO HEAD
PATIENT DISCOMFORT DUE TO TRANSDUCER TEMPERATURE INCREASE
DISPLAY INDICATES ERROR HEAD
Preventive Maintenance and Conservation
SOLUTIONS:
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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 INFORMATION PERSISTS, C ONTACT THE TECHNICAL SUPPORT
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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 i s 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 ap propriately.
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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
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SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz Fuses : 2.0A 250V 20AG -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Classification of of agreement with NBR IEC 60601.1 and and IEC 60601.2.5 standards: - Type of protection against electric shock:..........................................class 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 methods:.....................................see preventive maintenance - Degree of application safety in the presence of an inflammable anesthetic mixture with air, oxygen or nitrous oxide:...................................not oxide:...................................not adequate - Mode of operation:........................................................ operation:.......................................................................continuous ...............continuous ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------: Operating Frequency Sonomed IV = 1,0 MHz 5% Sonomed III = 3,3 MHz 5% : Continuous and Pulsed Mode of Operation of U.S output : Intensity in W/Cm2 Indication of output control : Power in W (SATP*) : 10W 10% Maximum effective output power : Maximum effective intensity Continuous mode : 2 W/Cm2 : 3 W/Cm2 Pulsed mode 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. : 100–230 V~ automatic (± 10%) / 50 / 60 Hz Hz : 65 VA
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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
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: 1 to 20 min : 1 to 5 min. ±30 sec. : 5 to 10 min. ±10% ±10% : 10 to 20 min. ±1 min.
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SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
(LxAxP) cm : 30 x 11 x 20 Size : 1.2 Kg Weight : Class II Protection against risk of electric shock : BF Type Degree of protection of applied part : IPX0 Protection against water penetration : Continuous Mode of operation : 11-248 UMDNS Classification
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: Environmental temperature : -10ºC to 50oC Relative humidity : 20% to 90% Atmospheric pressure : 500hPa to 1060hPa
* SATP (Spatial Average Temporal Peak) – Mean power value
Accessories:
Head Applicator (transducer):
SONOMED III 4134 Transdutor 5 cm2 , freqüêncy 3,3 MHz Acrylic Transductor Support Adhesive for fixing the Support in the device Tripolar power cable Gel Tube – 200ml User’s manual
Code 22717G Code 19343G Code 19738G Code 14747G Code 7000/200 Code 17870G
SONOMED IV 4144 Transdutor 5 cm2 , freqüêncy 1,0 MHz Acrylic Transductor Support Adhesive for fixing the Support in the device Tripolar power cable Gel Tube – 200ml User’s 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 : 3.5cm2 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
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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.
: +15ºC to +40ºC
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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 buildings with domestic domestic purposes. 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
± 6 kV contact ± 8 kV air
Voltage drop, short cut-offs and voltage variations in electric power supply. IEC 61000-4-11
Electromagnetic environment - instruction
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 %.
Magnetic fields of network frequencies (50/60 Hz) IEC 61000-4-8 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 the voltage voltage of AC network network before application application of testing 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
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Level of compliance
Electromagnetic environment - instruction
± 2 kV mains DECLARATION OF MANUFACTURER AND INSTRUCTION – ELECTROMAGNETIC IMMUNITY
Not applicable applicable
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.
± 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
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SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz applicable for the transmitter frequency. Recommended separation distance d 1.17. P
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
3V
3 V/m
80 MHz to
800 MHz
d 2.3. P 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).
Interference can occur around the equipment with the following symbol:
NOTE 1: in t he range of 80 MHz and 800 MHz, it applies the highest frequency of the range. NOTE 2: this procedure procedure may not not apply to all the situations. situations. The electromagnetic electromagnetic propagatio propagation n is affected by absorption and reflection of structures, objects and people. a. The intensity of fields generated generated by fixed transmitters such as radio- ase 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.
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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 keeping a minimum distance distance between between portable portable and mobile mobile RF communicati communication on 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 a location , should be lesser than the level b of compliance in each frequency range.
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Separation distance according to transmitter frequency Declared maximum output power of the transmitter transmitter (W)
150 kHz to 80 MHz
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
d 1.17. P
80 MHz to 800 MHz d 1.17. P
800 MHz to 2.5 GHz d
2.3.
P
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 transmitter manufacturer. 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. situations. The electromagnetic electromagnetic propagation 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.
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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.
Manufacturer Data CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda. CNPJ [Corporate Taxpayer’s Roll/Treasury Department] 61.461.034/0001-78 I.E. [State Registration] : 110.182.450.113 Rua Álvares Fagundes, 359 359 – São Paulo – SP – Brazil – CEP [Zip Code] 04338-000 Tel.: (11) 5621 2791 Fax.: (11) 5621 7024 email:
[email protected] website: www.carci.com.br
SONOMED IV 4144 – 1 MHz SONOMED III 4134 – 3 MHz
Lehman J. F. “Effects of therapeutic temperature on tendon extensibility” arch. Phys. med. rehab. 51-481 (1970).
Bearzy H. “Clinical application of ultrasonic ultrasonic energy energy in treatment of acute and chronic subacromial bursitis”, arch. Phys., med. Rehab, 34-228 (1953).
Griffin J. E. E. e outers “Ultrasonic movement movement of cortisol in pigtis sues sues II peripheral nerve”, Am. J. Phys. Med. 41, 20 (1965).
Touchstone J. C. e outers “Cortisol in human nerve” nerve” Science Science 142-1275 (1963).
Lehman J. F. e outers “The effect of of ultrasound waves on the permeability of biological membranes”. Strahienther, 79 (4) p.553 (1944).
Patrick k. M. “Ultrasound “Ultrasound in physiotherapy”, Ultrasonics. 4 p.p. 10 14 (1976)
Cyarlax j., “Textbook of orthopedic medicine”, vol. 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 Álvares Fagundes, 359 – São Paulo – SP – Brazil – CEP 04338-000 Tel.: (11) 5622 8205 / 5625 3104 email:
[email protected] Technician In Charge: Orlando Orlandi Melo de Carvalho Carvalho - CREA 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).
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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:
[email protected]
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