Professional Documents
Culture Documents
Ref. 4134
Sonomed IV
Ref. 4144
User Manual
English
Revision : 06
Carci Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CNPJ 61.461.034/0001-78
Made in Brazil
Presentation
02 .............Presentation
02 .............Accessories supplied with the device
03 .............General Information
05 .............Symbols
06 .............Installation / Connection to mains supply
08 .............Installation of Transductor Support
09 .............Display Language
10 .............Ultrasound energy
10 .............Ultrasound therapy
11 .............Continuous and Pulsed Mode
12 .............Cases where the Pulsed mode is advised
13..............Graphic representation of Pulsed Mode
15 .............Operational Flow Chart
16 .............Controls
17 .............Transductor
18 .............Appliance operation
21 .............Protocols
28 .............Indications
30 .............Contraindications
30 .............Corrective maintenance
31 .............Preventive maintenance and conservation
32 .............Precaution Instructions
33 .............Technical Specifications
36 .............Declarations
40 .............Final considerations
41 .............Bibliographical References
MU_4144_4134_ENG_Version_06
(01_2011)
SONOMED IV 4144
MU_4144_4134_ENG_Version_06
(01_2011)
General Information
The CARCI SONOMED IV 4144 and SONOMED III 4134 ultrasound were
developed with the purpose of providing the essential support that the
ultrasound technology allows to the clinical physiotherapy practice.
The Ultrasound is a mechanical stimulus directed to the body through
ultrasonic beam emitted by a transducer / applicator, better known as head.
This Ultrasound is produced in the head through a piezo-electric crystal and
transmitted to the body through the aluminum surface of the head and a
contact agent (gel). As the Ultrasound beam crosses the tissues, its energy
is gradually and selectively absorbed, and among other effects, being
transformed into heat. This increase of temperature provokes biological
alterations in the tissues, as well an increase in the micro-circulation, a
reduced perception of pain, a reduction of inflammatory activity and an
increase in the restoration rate of delicate tissues. The higher the frequency
of the Ultrasound, the more superficial its absorption will be, as it may be
seen in the figure below:
1 Mhz
Effec tive
depth
Penetrating
point
3 Mhz
1cm
3cm
3cm
Effec tive
depth
Penetrating
point
9cm
MU_4144_4134_ENG_Version_06
(01_2011)
MU_4144_4134_ENG_Version_06
(01_2011)
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.
Manufacturing date
Minimum and maximum temperature limits for
transport and storage.
Serial number
Manufacturer identification
IPX7
Class II Equipment
MU_4144_4134_ENG_Version_06
(01_2011)
MU_4144_4134_ENG_Version_06
(01_2011)
2 Step
The electric power supplys voltage must be within the range specified
in the Technical Features, otherwise, there can be reduced equipment
performance and safety risk.
Protection cover
Adhesive
3 Step
Choose the side and paste the Acrylic support in the device, according to
Picture below:
OR
Left side
Right side
4 Step
Fit the transductor in the Acrylic Support.
MU_4144_4134_ENG_Version_06
(01_2011)
MU_4144_4134_ENG_Version_06
(01_2011)
Display language
Ultrasound Energy
In case you wish to change the current language, follow the steps below:
1.
2.
3.
Protocols
4.
5.
6.
7.
8.
9.
Set
MU_4144_4134_ENG_Version_06
Ultrasound therapy
(01_2011)
MU_4144_4134_ENG_Version_06
(01_2011)
10
Depth heat affects muscles temperature . A five minutes treatment can lift
up the temperature from one to two degrees centigrade. The effects of the
heat associated to that of micro-massage provoke a relaxation of the
muscles, and consequently largely reduce the muscular spasms with
localized nature (2).
Another effect what we can quote is that the permeability of the membranes
is altered not only by thermal effects, but also because minute currents
produced by the ultrasound can increase the rate of diffusion and the
gradient of concentration of the membranes, according to studies of
Lehman, Becker and Other (7).
MU_4144_4134_ENG_Version_06
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11
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12
Other conditions reported by Cyaruax (9) that respond very well to the
treatment by Pulsed ultrasound: hematomas, hypertrophic scars and certain
muscular traumas. In this last case the ultrasound provokes an alignment of
the healthy fibers along the longitudinal axle of the muscle.
Amplitude
10%
T on
Time
T off
T
Amplitude
f= 1/T
T on
50 %
Work cycle:
20%
10%
Freq. (f) Period (T)
Ton Toff
Ton Toff
Ton Toff
100Hz
10ms
5ms
5ms 2ms
8ms 1ms 9 ms
48Hz
~20ms Non-applicable 4ms 16ms 2ms 18 ms
16Hz
~62ms Non-applicable 12ms 50ms 6ms 56ms
Relation Ton/Toff
1:2
1:5
1:9
50%
Time
T off
T
f=1/T
Amplitude
20%
T on
Time
T
T off
f=1/T
MU_4144_4134_ENG_Version_06
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13
MU_4144_4134_ENG_Version_06
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14
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
Start Therapy
(01_2011)
15
MU_4144_4134_ENG_Version_06
(01_2011)
16
Appliance operation
Protocols
W
W/cm 2
Set
Start
Stop
1.
1 MHz
4144
Transductor :
Transductor Characteristics
Serial
Number
3.3 MHz
Serial
Number
4134
2. Connect the Power cable in the Sonomed than in Power grid.
reas indication
MU_4144_4134_ENG_Version_06
Support position
(01_2011)
17
MU_4144_4134_ENG_Version_06
(01_2011)
18
3. Turn on the appliance the equipment will perform a test of the display
and the circuit of the processor and will issue a double beep in case it is
failure free.
Timer
Intensity
Sonomed IV 4144
Mode
Freq
Duty
Intensity
6. With the
Freq
Duty
7. Use the
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.
In pulse mode:
Mode
Freq
Timer
Duty
Intensity
Puls
00:00
MU_4144_4134_ENG_Version_06
Freq
8.
9.
key.
10. At the end of treatment time , a double beep will sound and the output
circuit will be disabled.
Duty
16Hz
10%
0.0 W/Cm2
(01_2011)
19
MU_4144_4134_ENG_Version_06
(01_2011)
20
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.
Mode
MU_4144_4134_ENG_Version_06
(01_2011)
21
MU_4144_4134_ENG_Version_06
Freq.
Protocols
Duty
(01_2011)
22
Freq.
W to DEL
C_ _ _ _ _ _ _
Intensity
Freq.
Duty
Prot.
User
Timer
Mode
W to DEL
CA_ _ _ _ _ _ _
Intensity
Freq.
W to DEL
_________
Duty
Mode
FIX
Prot.
Save
Timer
USER
Set
Intensity
Mode
SAVE
Duty
Prot.
Fix
W to DEL
CARCI_ _ _ _ _ _ _
Timer
Intensity
Save Protocols :
Select the option :
MU_4144_4134_ENG_Version_06
Prot.
Save
Set
The protocol will be saved in the memory and the display will show it in the
main screen.
(01_2011)
23
MU_4144_4134_ENG_Version_06
(01_2011)
24
Upon ending up the treatment a double beep will sound and the output
circuit will be disabled.
User Protocols :
Prot.
User
Prot.
Usuario
Set
Press the key
Prot.
W to DEL
Carci 1 _ _ _ _ _ _ _
Set
Prot.
W to DEL
Carci 1 _ _ _ _ _ _ _
Prot.
W to DEL
Carci 2_ _ _ _ _ _
Prot.
W to DEL
Carci 2_ _ _ _ _ _
Set
Afer select the desired protocol, press the key
to delet the selected Protocol.
Apagar?
Carci2
Set = Yes
Prot=No
Sta rt
cla
Stop
MU_4144_4134_ENG_Version_06
(01_2011)
25
MU_4144_4134_ENG_Version_06
(01_2011)
26
Set
Set
to keep it
Prot.
T. Ext
to return.
Fix Protocols :
Select the option :
Prot.
Fix
Set
Hand
Prot.
Main
---------
Set
Prot.
T. Ext
Hand
Continuo
05:00
0.8 W/cm2
Prot.
Hand
Sta rt
Stop
Upon ending up the treatment a double beep will sound and the output
circuit will be disabled.
Prot.
Bursite
MU_4144_4134_ENG_Version_06
Shoulder
Indications of Ultrasound
(01_2011)
27
MU_4144_4134_ENG_Version_06
(01_2011)
28
Neuritis
Arthritis
Distensions
Adherences
Sciatic
Edemas
Scars
Bursitis
Traumas
Stiff necks
Tenosinovitis
Sacro-Iliac distension
Contraindications
Corrective Maintenance
Common cases found in athletes who may respond well to the treatment by
ultrasound as adjuvant therapeutic agent:
Injuries
MU_4144_4134_ENG_Version_06
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29
MU_4144_4134_ENG_Version_06
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30
SOLUTIONS:
EQUIPMENT:
DOES NOT TURN ON
DISPLAY INDICATES
NO HEAD
PATIENT DISCOMFORT
DUE TO TRANSDUCER
TEMPERATURE INCREASE
DISPLAY INDICATES
ERROR HEAD
MU_4144_4134_ENG_Version_06
(01_2011)
31
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.
Control, with regularity, the power supply and the cable, certifying that
no defects are found.
Control, with regularity, the cable of the transducer, certifying that the
cable is not twisted or its insulation is damaged, that the connections of
the cable in the connectors are in perfect conditions and that there is no
gel accumulated on the side surface of the transducer.
The estimated useful life of the equipment is 5 years. After this period, it
is recommended for the equipment to be subjected to a full inspection
by CARCI in order to continue using it in a safe and efficient manner.
MU_4144_4134_ENG_Version_06
(01_2011)
32
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;
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.
Technical specifications
Origin
Model
SONOMED IV 4144
SONOMED III 4134
Function and application
Electric supply
Maximum consumption
MU_4144_4134_ENG_Version_06
: CARCI Brazil
1.0 MHz
3,3 MHz
: ultrasound generating
equipment for therapy.
: 100230 V~ automatic
( 10%) / 50 / 60 Hz
: 65 VA
(01_2011)
33
Timer
Accuracy
MU_4144_4134_ENG_Version_06
:
:
:
:
1 to 20 min
1 to 5 min. 30 sec.
5 to 10 min. 10%
10 to 20 min. 1 min.
(01_2011)
34
Size
(LxAxP) cm
: 30 x 11 x 20
Weight
: 1.2 Kg
Protection against risk of electric shock
: Class II
Degree of protection of applied part
: BF Type
Protection against water penetration
: IPX0
Mode of operation
: Continuous
UMDNS Classification
: 11-248
Relative humidity
Atmospheric pressure
: 0% to 80%
: 700 hPa to 1060hPa
Acc essories:
H e a d A p p l i c a t o r ( t ra n s d u c e r) :
Users manual
Code 22717G
Code 19343G
Code 19738G
Code 14747G
Code 7000/200
Code 17870G
SONOMED IV 4144
2
Users manual
Code 22716G
Code 19343G
Code 19738G
Code 14747G
Code 7000/200
Code 17870G
Model 4134
Type
Operating Frequency
Aplicator Area
Geometric Area transducer
Effective Radiation Area (ERA)
Max. Intensity Ratio (BNR)
Water tightness
Weight
Maximum acoustic power
: Collimated
: 3,3 MHz 5%
: 10 cm2
: 5 cm2
2
: 3.5cm 20%
: < 6.0 : 1
: IPX7
: 215 grams
: 10 Watts
Model 4144
Type
Operating Frequency
Aplicator Area
Geometric Area transducer
Effective Radiation Area (ERA)
Max. Intensity Ratio (BNR)
Water tightness
Weight
Maximum acoustic power
: Collimated
: 1,0 MHz 5%
: 10 cm2
: 5 cm2
: 3.5cm2 20%
: < 6.0 : 1
: IPX7
: 215 grams
: 10 Watts
MU_4144_4134_ENG_Version_06
RF emission
CISPR 11
Compliance
Group 1
: +15C to +40C
(01_2011)
35
MU_4144_4134_ENG_Version_06
(01_2011)
36
Class B
Class A
Compliant
Level of IEC
60601 testing
6 kV contact
8 kV air
Level of
compliance
Electromagnetic
environment - instruction
6 kV contact
8 kV air
Voltage drop,
short cut-offs and
voltage variations
in electric power
supply.
IEC 61000-4-11
Magnetic fields
of network
frequencies
(50/60 Hz)
IEC 61000-4-8
<5% Ut
(>95% drop in Ut)
For 0.5 cycle
<5% Ut
(>95% drop in
Ut)
For 0.5 cycle
40% Ut
(60% drop in Ut)
For 5 cycles
40% Ut
(60% drop in
Ut)
For 5 cycles
70% Ut
(30% drop in Ut)
For 25 cycles
70% Ut
(30% drop in
Ut)
For 25 cycles
<5% Ut
(>95% drop in Ut)
For 5 s
<5% Ut
(>95% drop in
Ut)
For 5 s
3 A/m
3 A/m
Immunity
testing
Level of IEC
60601 testing
Fast transient /
Bursts
IEC 61000-4-4
2 kV mains
1 kV in and out
signal line
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common
mode
MU_4144_4134_ENG_Version_06
Level of
compliance
Electromagnetic
environment - instruction
2 kV mains
DECLARATION OF MANUFACTURER AND INSTRUCTION
ELECTROMAGNETIC IMMUNITY
SONOMED is destined for use in the electromagnetic environment specified below. The
SONOMED buyer or operator should ensure that it is in use in such environment.
Not applicable
1 kV
differential
mode
2 kV common
mode
Immunity
testing
Level of IEC
60601 testing
Level of
compliance
(01_2011)
37
MU_4144_4134_ENG_Version_06
(01_2011)
38
Conducted
RF
IEC 610004-6
3 Vrms
150 kHz to 80
MHz
Radiated RF
IEC 610004-3
3 V/m
80 MHz to 2.5
GHz
d 1.17. P
d 1.17. P
3V
800 MHz
3 V/m
2.5 GHz
d 2.3. P
80 MHz to
NOTE 1: in the range of 80 MHz and 800 MHz, it applies the highest frequency of the
range.
NOTE 2: this procedure may not apply to all the situations. The electromagnetic propagation
is affected by absorption and reflection of structures, objects and people.
a. The intensity of fields generated by fixed transmitters such as radio-base stations for
telephones (cellular / wireless) and land mobile radios, amateur radios, AM, FM and
TV radio-diffusion stations cannot be theoretically prognosticated with precision. To
evaluate the electromagnetic environment due to fixed RF transmitters, a study of the
electromagnetic field at the location should be considered. If the intensity of the field
measured at the location in which SONOMED is used exceed the level of compliance
above, the SONOMED should be observed to check if it is working normally. If
abnormal performance is noted, additional measures may be necessary, such as reinstruction or relocation of the SONOMED;
b. Above the frequency scale of 150 kHz to 80 MHz, the field intensity should be less than
3 V/m.
(01_2011)
800 MHz to
MU_4144_4134_ENG_Version_06
39
d 1.17. P
80 MHz to 800
MHz
d 1.17. P
d 2.3. P
0.01
11.70 cm
11.7 0 cm
23.00 cm
0.1
37.00 cm
37.00 cm
72.70 cm
1.17 m
1.17 m
2.30 m
10
3.70 m
3.70 m
7.27 m
100
11.70 m
11.70 m
23.00 m
For transmitters with declared maximum output power not listed above, the recommended
separation distance (d in meters) can be determined using the equation applicable to
transmitter frequency; P is the maximum output power of transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1: to 80 MHz and 800 MHz, applies to the separation distance for the highest
frequency.
NOTE 2: this procedure can apply to all situations. The electromagnetic propagation is
affected by absorption and reflection of structures, objects and people.
Final considerations
It has been Carci policy to continuously improve the quality of its products.
Carci reserves the right to make modifications on the design and its
specifications, and also add to and improve its products, without being
liable for installing them in already manufactured products.
The text, illustrations and specifications contained in this manual are based
on information available in print.
All rights reserved.
MU_4144_4134_ENG_Version_06
(01_2011)
40
Manufacturer Data
CARCI Indstria e Comrcio de Aparelhos Cirrgicos e Ortopdicos Ltda.
CNPJ
[Corporate
Taxpayers
Roll/Treasury
Department]
61.461.034/0001-78
I.E. [State Registration] : 110.182.450.113
Rua lvares Fagundes, 359 So Paulo SP Brazil CEP [Zip Code]
04338-000
Tel.: (11) 5621 2791
Fax.: (11) 5621 7024
email: carci@carci.com.br
website: www.carci.com.br
Bibliographic References
EUROPEAN REPRESENTATIVE
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MU_4144_4134_ENG_Version_06
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MU_4144_4134_ENG_Version_06
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43