SONOMED V 4150 - 1&3 MHz Tables of contents
Sonomed V 4150
User Manual
02 ............. Presentation 02 .............Accessories supplied with the device 03 .............General Information 05 .............Symbols 06 .............Installation / Connection to mains s upply 08 .............Installation of Transductor Support 09 .............Display Language 09 .............Ultrasound energy 10 .............Ultrasound therapy 11 .............Continuous and Pulsed Mode 11 .............Cases where the Pulsed mode is advised 12..............Graphic representation of Pulsed Mode 14 .............Operational Flow Chart 15 .............Controls 17 .............Appliance operation 18 .............Protocols 22 .............Indications 24 .............Contraindications 24 .............Corrective maintenance 25 .............Preventive maintenance and conservation 25 .............Precaution Instructions 26 .............Technical Specifications 29 .............Declarations 33 .............Final considerations 34 .............Bibliographical References
English
Revision : 06 MU_4150_ENG_Rev_04_092009
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SONOMED V 4150 - 1&3 MHz
SONOMED V 4150 - 1&3 MHz
Presentation
General Information
Carci is proud to congratulate you for the acquisition of a high technology and security equipment. Where we are sure this equipment will satisfy the highest quality standards. SONOMED V – 4150 device was designed according to IEC 60601.1:1994 + amend 1:1997, IEC 60601-1-2:2006 and IEC 60601-2-5:1997 safety rules, which makes them a safe and reliable product.
The Ultrasound CARCI SONOMED V was developed with the purpose of providing the essential support that the ultrasound technology allows to the clinical physiotherapy practice. The Ultrasound is a mechanical stimulus directed to the body through ultrasonic beam emitted by a transducer / applicator, better known as head. This Ultrasound is produced in the head through a piezo-electric crystal and transmitted to the body through the aluminum surface of the head and a contact agent (gel). As the Ultrasound beam crosses the tissues, its energy is gradually and selectively absorbed, and among other effects, being transformed into heat. This increase of temperature provokes biological alterations in the tissues, as well an increase in the micro-circulation, a reduced perception of pain, a reduction of inflammatory activity and an increase in the restoration rate of delicate tissues. The higher the frequency of the Ultrasound, the more superficial its absorption will be, as it may be seen in the figure below:
Accessories supplied with the device SONOMED V 4150 • • • • • • •
01 Transductor 5 cm2 freqüêncy: 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 User’s manual
1 Mhz Effective depth
To buy optional accessories, please verify the codes at page 28, item : Accessories. If you have any doubt, please contact:
Penetrating point
3 Mhz 1c m 1cm 3cm 3c m
3c m
Effec tive depth Penetrating point
9c m
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 V 4150 - 1&3 MHz In the application of Pulsed Ultrasound in low frequencies (48Hz and 16Hz), a reduction is observed in the heat produced in the tissues, and certain non-thermal effects are obtained at cell level, such as an increase in the permeability level of the cell membranes and a reduction in the inflammatory actions.
SONOMED V 4150 - 1&3 MHz Symbols Equipment symbols Equipment off
The mechanical and electrical characteristics of the transducer are a result of intense researches carried out intending to obtain a regular ultrasound beam and with no diffusion. These characteristics were obtained through the measurement of the acoustic field in the transducer and subsequently, graphic analysis of the relative pressure in function of the distance of the transducer where ERA (effective radiation area) and BNR (non-uniformity relation of the ultrasound beam) were determined.
Equipment on This equipment has physiological effects. Consult instructions manual.
An intensity indicating scale was determined through the method of measuring the pressure of the acoustic radiation by using a digital Wattmeter, which allowed for great accuracy in the values of intensity scale (dosages).
Applied part is type BF
The decision of using Ultrasound therapy as a form of treatment for your patient should always be substantiated on a deep clinical knowledge of the pathology and in an intimate understanding of the possibilities and limitations of Ultrasound therapy.
Manufacturing date Serial number Manufacturer identification
IPX7
This symbol indicates that the head he ad is waterproof.
IPX0
This symbol indicates that the equipment isn’t waterproof. Class II Equipment
CE Mark and certifying body identification European representative MU_4150_ENG_Rev_04_092009
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SONOMED V 4150 - 1&3 MHz
SONOMED V 4150 - 1&3 MHz 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.
Symbols on the pack
Connect the power cable to a three-pin connector located in the back panel and connect it to the power supply socket
Caution fragile. Handle with care
•
Keep in a dry place This side up. This symbol indicates the right transport position Maximum piling. Indicates the maximum number of boxes that can be piled. The quantity is marked in the intermediary square. Minimum and maximum temperature limits for transport and storage.
Installation / Connection to mains supply For perfect operation of your equipment, we suggest that the electrical installations comply with the following standards:
Your equipment uses switched power supply and operates in any voltage between 100V~ and 240V~ 50 or 60Hz. In case of blowing up the protection fuse replace it only with the appropriate • value: The fuses should be: 2.0A be: 2.0A 250V 20AG •
Remove the lid of the fuse holder with the help of a screwdriver (insert the point of the screwdriver in the groove of the fuse holder, apply light pressure and turn to the counterclockwise direction)
Brazil:
NBR 5410/1990 – Low-voltage electrical installations; NBR13534/1995 – Electrical installations in health establishments – Safety requisites. Other countries: IEC 60364-7-710/2002 – Electrical installations – medical locations; • Or another listed standard applied in the country of use. • • •
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SONOMED V 4150 - 1&3 MHz
SONOMED V 4150 - 1&3 MHz
Installation of Transductor Support
Display language
1°Step Paste the adhesive in the acrylic According Picture below:
Portuguese
2°Step Remove the protection cover
SONOMED allows three display languages to be accessed:
English
Spanish
Protection cover
In case you wish to change the current language, follow the steps below: 1. 2.
Acrylic Support
Adhesive
3.
3°Step Choose the side and paste the Acrylic support in the device, according to Picture below:
Protocols 4.
5.
OR Left side
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
After the equipment emits a double beep, release the
Protocols key.
6.
The display will show the accessible languages: ENGLISH PORTUGUESE SPANISH Select the desired language through the keys
7.
Press the key
8.
Switch off the SONOMED.
Right side
4º Step Fit the transductor in the Acrylic Support.
Set
Ultrasound Energy It is a form of energy obtained when an electric oscillating voltage is applied on a transducer that, for its piezo-electrical characteristics, deforms, expanding and contracting in the same frequency as the applied electric voltage. This way, ultrasound waves are produced that have fundamentally great capacity of in-depth heating of tissues. MU_4150_ENG_Rev_04_092009
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SONOMED V 4150 - 1&3 MHz The nerve roots to be treated should sh ould 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/cm 2 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/cm 2 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.
SONOMED V 4150 - 1&3 MHz
Amplitude
10% 10%
T on
Time T
Graphic representation of Pulsed Mode
T off
f=1/T
Amplitude
Work cycle: 20% 10% Freq. (f) Period (T) Ton Toff Ton Toff Ton Toff 100Hz 10ms 5ms 5ms 2ms 8ms 1ms 9 ms 48Hz ~20ms Non-applicable 4ms 16ms 2ms 18 ms 16Hz ~62ms Non-applicable 12ms 50ms 6ms 56ms Relation Ton/Toff 1:2 1:5 1:9
T on
50% 50 %
50%
Time T off T
f (frequency) = 1/T (period) active Time Toff = resting Time
f=1/T
Ton =
Amplitude
20% 20%
100Hz with work cycle of 10 %, 20 % or 50 % That is for 10 % 1 ms active time and 9ms rest – 1:9 ratio 20 % 1 ms active time and 8ms rest – 1:5 ratio 50 % 1 ms active time and 5ms rest – 1:2 ratio 48 Hz with work cycle of 10 % or 20 % That is for 10 % 2 ms active time and 18ms rest – 1:9 ratio 20 % 4 ms active time and 16ms rest – 1:5 ratio 16 Hz with work cycle of 10 % or 20 % This is for 10 % 6 ms active time and 56ms rest – 1:9 ratio 20 % 12 ms active time and 50ms rest – 1:5 ratio
T on
Time T
T off
f=1/T
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SONOMED V 4150 - 1&3 MHz
SONOMED V 4150 - 1&3 MHz Controls
FLOWCHART FOR ULTRASOUND THERAPY ��������� �� �� �������
ACUTE OR CHRONIC
ACUTE
CHRONIC
DESIRABLE THERMAL EFFECT
UNDESIRABLE THERMAL EFFECT
DEPTH TO BE REACHED
CONTINUOUS MODE
US 1 MHz
Yes
MORE THEN 1 cm
PULSED MODE
No
Cursor Movement Keys:
US 3 MHz
TYPE OF APPLICATION : STANDARD (GEL) / SONOPHORESIS / UNDER WATER
CHOOSE APPLICATION PARAMETERS
Start Therapy
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SONOMED V 4150 - 1&3 MHz
SONOMED V 4150 - 1&3 MHz Appliance operation
Protocols
Set
W 2 W/cm
Sta rt Stop
1.
Connect the transductor in Sonomed, according to Picture below :
1.0/ 3.3 MHz
Transductor : 2. Connect the Power cable in the Sonomed than in Power grid.
Transductor Characteristics Characteristics
3. Turn on the appliance – the equipment will perform a test of the display and the circuit of the processor and will issue a double beep in case it is failure free
SONOMED UHT 4100
1.0 /3.3 Mhz IPX7 Collimating Era: 3,5 cm P.Max:7,2 W BNR<6:1 S/N: 4150zzzz
Áreas indication
4. Select through the keys
the wanted parameters:
Support position
For selecting the wanted Value use:
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SONOMED V 4150 - 1&3 MHz The values that can be selected in the continuous mode are as follows: Frequency 1 / 3 MHz Mode: Continuous / Pulsed Timer: 0 Timer: 0 to 20 min. Intensity: 0.0 Intensity: 0.0 to 2.0 W/cm2
SONOMED V 4150 - 1&3 MHz Limitations of Liability
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 circuit will be turned on.
Start Stop
and the output
In no case Carci Ind. e Com. e Com., or its suppliers and / or distributors, are liable by any indirect, special, incidental damage caused by the use or inability to use the product, including, without limitation of damages due to loss, or any and all other commercial damage or loss, and independently of the legal or equitable theory (contract, appeal or another mode) on which the claim is based. Carci cannot be held responsible for any consequence resulting from incorrect information provided by its staff, or errors included in this manual and / or another attached documentation (including commercial documentation) Sonomed V has around 15 treatment protocols suggestions and enables record 18 user protocols. Below, a description of the protocols according to the application area, for the frequencies: 1MHz and 3.3 MHz, recorded in Sonomed V memory:
7. Upon ending up the treatment a double beep will sound and the output circuit will be disabled. 8. Press the key
Start Stop
Protocols Atention Before applying the treatment protocols the operator should be well informed about the contents of this manual as well as on the operation of this equipment and all aspects related with the treatment of the patient.
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SONOMED V 4150 - 1&3 MHz In case you want to use the PROTOCOLS, the PROTOCOLS, press press the key The display will give the Following screen :
Use the keys to select the desired PROTOCOL. 1. BACK Go back to the main screen . Press the
key to Return.
2.SAVE Record the protocol in the memory. Press the
Protocols
Use the and to select the letter desired.
keys
PROTOCOLS BACK SAVE USER FIX
Press the or the key
6 f p z
7 g q ç
8 h r ,
9 0 i j s t .
to erase.
To record the protocols press the key:
PROTOCOLS FREQUENCY MODE FREQUENCY DUTY CYCLE TIMER 0 min
1 2 3 4 5 a b c d e k l mn o u v wx y Stp to DEL
key to write,
1 2 3 4 5 a b c d e k l mn o u v wx y Stp to DEL test rec
Protocols
1 MHz CONTINUOUS
INTENSITY 0,0 W/cm2
key to select the record mode.
The display will give the following screen
SONOMED V 4150 - 1&3 MHz
This display shows the main screen
PROTOCOLS FREQUENCY MODE FREQUENCY DUTY CYCLE TIMER 10 min
TEST REC 1 MHz CONTINUOUS
INTENSITY 1,0 W/cm2
3. USER’S The display will give the following Protocols recorded 6 f p z
7 g q ç
8 h r ,
9 0 i j s t .
Press the key to enable the Selected mode User’s.
PROTOCOLS
W TO DEL
XXXXX
YYYYY ZZZZZ
--------------
OBS.: If the parameters timer and intensity are in blanck it will not be possible to save
Use the
keys to select the Protocol desired, and Press the key to enable the selected Protocol.
For erase the Protocol, select the Protocol desired and press the MU_4150_ENG_Rev_04_092009
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SONOMED V 4150 - 1&3 MHz
SONOMED V 4150 - 1&3 MHz • • •
key.
PROTOCOLOS
STP TO DEL
•
DELETE ? SET = YES PROTOC = NO
•
XXXXX
YYYYY ZZZZZ
The display will give the following screen :
• •
For erase press the
key, or the
Protocols
•
to keep.
•
• •
To return to main screen, you must to select a Protocol and press
• • • •
key
PROTOCOLS MAIN
4. FIX The display will give the following Sonomed Protocols.
Use the
Hand Shoulder Elbow Hip Knee
• • •
•
keys to select the protocol desired, and Press the
•
• •
key to enable the selected Protocol.
•
Common cases found in athletes who may respond well to the treatment by ultrasound as adjuvant therapeutic agent:
Indications of Ultrasound The indications presented by the literature are based on biophysics researches, which in most of the cases coincide with those originating from the empiricism developed by the clinical practice. These indications are based fundamentally on the capacity of the ultrasound in selectively heating the tissues. The ultrasound has been used successfully as joint therapy in the following general cases: •
Arthrosis (large and small articulations) MU_4150_ENG_Rev_04_092009
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
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• • • • • • • • • •
Injuries Neuritis Arthritis Distensions Adherences Sciatic Edemas Scars Bursitis Traumas
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SONOMED V 4150 - 1&3 MHz Technician In Charge: Orlando Orlandi Melo de Carvalho - CREA CREA 5061377287/D
SONOMED V 4150 - 1&3 MHz •
Touchstone J. C. e outers “Cortisol in human nerve” Science 142-1275 (1963).
•
Lehman J. F. e outers “The effect of ultrasound waves on the permeability of biological membranes”. Strahienther, 79 (4) p.553 (1944).
•
Patrick k. M. “Ultrasound in physiotherapy”, physiotherapy”, Ultrasonics. 4 p.p. p.p. 10 14 (1976).
•
Cyarlax j., “Textbook of orthopedic medicine”, vol. vol. 1, Baltimore, Baltimore, William & Wilkins (1975).
•
J.F.Lehman, e outers “Pain threshold measurements after therapeutic application of ultrasound, microwaves and infrared. Arch. phys. med., 39, p 560 (1978).
EUROPEAN REPRESENTATIVE OBELIS S.A. 34, Av. de Tervuren, bte 44 B-1040 Brussels, BELGIUM Tel: (32) 2.732.59.54 Fax: (32) 2.732.60.03 E-mail:
[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 “Ultrasonic movement of cortisol in pigtis sues II peripheral nerve”, Am. J. Phys. Med. 41, 20 (1965). MU_4150_ENG_Rev_04_092009
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