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1.0 INTRODUCTION
This manual gives all the necessary information for a correct use of the unit
for all models of Roland2 series.
Up to 5 different generator that the operator may combine with reference to his requi-
rements. Each operator may build his own device
The first special feature which is also perceptible from the first look of the different
units, it is made by the operations and the control-panel. Both of them are the same
for all the available devices. The same LCD, the same buttons, the same track-ball, also
the same software which allows the operator to set each function for performing the
desired treatment.
All the models are provided with a large menu of preset pathologies which the ope-
rator may access to in a very simple way, but the operator can always modify all para-
meters with wide freedom of adjusting. The extreme easiness and functionality is pos-
sible thanks to the high technology of the Operative System Windows CE.
The supply of a wide free memory allows the operator to record different therapeutic
protocols that can be codified with the patient name, the name of the pathology, a
number or any other alphanumeric code. All the functions of the unit are automatical-
ly checked when main switch is turned on and are continuously monitored during ope-
ration.
3
2. FIELD OF APPLICATION
This unit has been designed and build in order to work in physical therapy for thera-
peutic, aesthetic or sporty purpose.
3.0 INSTALLATION
Before using the unit the first time we suggest to carry out a safety test and a working
test, in order to check the integrity of the unit after the carriage.
As far as particular installation procedure is concerned, read the handbook of the spe-
cific devices.
We inform you that the operating work place must be medical only and it must satisfy
the electrical rules in according to the European Standard CEI 64-4.
WORNING
Any physical therapy treatment must be carried out on
CONSCIOUS patients. Furthermore pay always attention to the
patient’s sensation while the output energy (electrical,
mechanical, high frequency, energy...) is increasing.
4.0 SWITCHING-ON
From the Menu “Applications setting”, move the cursor over the
label “Pathologies/Program” and a full list of pre-set pathologies
will appear.
■ Enter into the Menu “Applications setting” ■ Select one of the following available ap-
plications:
1) Manual 2) Pathologies 3) Memories
■ Enter into the Menu “Data setting” and
Switching-off
When the unit stops, remove all the applicators from the patient and press the button
placed on the back side of the unit for switching the unit off.
WARNING!
The laser units here considered are high power laser units and
during the treatment is therefore necessary to take care to avoid
fires. In particular the operator must make sure that during the 9
therapy: Is forbidden the use of anaesthetics, disinfectants
and/or fires solvents Is forbidden the use of paper sheets
Any object near the laser beam must be covered by a flame
tested material. The eventual instruments of support
of the patient must be covered
by a non-reflecting material (satinizing); the reflecting objects
near the laser beam must be covered by a by a non-reflecting
material. An extinguisher must be available
in the treatment's zone
emission modes
emission modes
■ 1064 nm source at 15 W, working in continuous, pulsed and super pulsed emission
modes
Available applicators
11
Each applicator may be connected and disconnected from optic fiber very simple. You
must take care to avoid to pull the optic fiber; the only part you have to press and to
pull is the metal connector and the relevant applicator.
In fact, each applicator is provided with a small hole where the connector must be en-
tered as shown here below.
12
Probes Technical features
Available
applicators
Ø 20 mm Ø 60 mm
Each applicator may be connected and disconnected from optic fiber very simple. You
must take care to avoid to pull the optic fiber; the only part you have to press and to
pull is the metal connector and the relevant applicator.
In fact, each applicator is provided with a small hole where the connector must be en-
tered as shown here below.
13
SCAN MODE
Generator
Parameters
[
■ Enter the password made by pressing + - + keys every time you switch the unit on.
■ Press OK for confirming
14
15
Low frequency magnetic fields are well known for their positive action into the treat-
ments of fractures, arthrosis, pseudoartrhosis, consolidation delay but they are also
used for treating tendons for stimulating connective fibres.
High frequency magnetic fields are provided with a working frequency of 2 GHz and
the modulation is adjustable from 10 to 5000 Hz
High frequency magnetic fields, thanks to the possibility to be deliver without any war-
ming effects, are positively applied for treating vascular pathologies, dermatology di-
seases and acute pathologies of tendons and muscles where warm is contraindicated.
Simultaneous and combined application of the two magnetic fields, by generally using
a low component of low frequency magnetic field, it is useful for combining stimula-
tion of connective tissue coming from LF with anti-inflammatory and anti-oedema ef-
fects coming from HF.
fications in the swelling condition of cells, a stimulation on the nervous endings and a
making of chemical substances having a tonic and an anti-tossic effect.
The main effects of the ultrasounds are analgesic, spasmolytic, anti-inflammatory and
bactericidal. The therapeutical indications are mainly based on these effects.
The ultrasound units are able to work both in continuous and pulsed mode. They
are equipped with waterproofed transducers in order to carry out treatment in water.
Have a list of preset protocols: it is enough to chose the name of the pathology from
the menu, and automatically the unit set the frequency (1MHz or 2MHz or 3MHz), the
emission mode (continuous or pulsed), the output effective intensity (W/cm2) and the
treatment time. The operator can change any parameter, if he wants.
The device informs the operator if there is not good contact and this avoids wrong tre-
atments, which are caused by no-contacts or wrong contacts with the tissue.
■ Programmable memory
■ Standard treatment procedures
■ Manual polarity inversion and automatic polarity inversion at half treatment time
10.2. CONTRAINDICATIONS
For safety reason, treatments concerning body parts such: eyes, heart and near pace-
maker, pregnant womb, ovaries, testicles ephiphyseal discs mustn't be performed.
In addition, in case of body parts affected by tumour, thrombophlebitis, varix and sep-
tic inflammations, it is advisable not to perform the U.S. therapy.
11 INFINITY MODEL
Universal waveforms generator provided with two independent outputs. It’s possible to
include up to 2 INFINITY electrotherapy generators into the EXPANDER x5 device. (that
means up to 4 independent outputs generator).
mod. INFINITY Fix: universal waveforms generator provided with two independent out-
puts and continuous and pulsed vacuum. It’s possible to include only one INFINITY FIX
electrotherapy with vacuum generator into the EXPANDER x5 device.
WORNING
Do not switch on or off the unit when the electrodes
are applied on the patient's body. This could lead to
some undesired and trouble current impulses.
The device is used for electrotherapy treatment in physical therapy and rehabilitation.
With reference to the kind of current set, you can get different effects: thermal, che-
mical (ionophoresis), exciting-motor and antalgic. For more details, see the bibliogra-
phy on the security handbook.. The treatment of the patient has to be made under in-
dication of a doctor and/or authorised personnel.
19
11.1 TECHNICAL FEATURES
■ Digitally adjustable treatment time (59 minutes)
■ Programmable memory
■ Manual polarity inversion and automatic polarity inversion at half treatment time
The pulse length, frequency and current intensity values are not different from the va-
lues written on this handbook, than more 20%.
11.3 PRELIMINARY
Before using the unit, be sure you have carefully read the previous paragraphs of this
handbook. Place the unit on a stable base, don't put anything on the unit and be sure
the ventilation grids are free. If all these rules have been followed, injuries to the pa-
tient and to the operator are virtually impossible. The current intensity must be chosen
according to the stage of the disease that must be treated. Galvanic currents can cau-
se skin-troubles. In order to prevent this kind of damages, especially when the skin is
subjected to prolonged treatments, current density must not exceed 0,2 mA/cm2. Ho-
20 wever, the patient's threshold of sensitivity must always be observed. Particular atten-
tion should be paid to those treatments with a current density over 0,2 mA/cm2
(efficacy value).
Before deciding current intensity, take into consideration also the size of the electrodes:
the smaller they are, the higher the current density. Feeling of pain or burn must be
avoided. For instance with 80mA as top efficacy value, the current density is
0,2mA/cm2 using a 400 cm2 electrode. In the following table are shown some exam-
ples.
*IM is the maximum allowable value for not going over 0,2mA/cm2
Place therefore an insulating cloth under the electrodes and those uncovered parts of
wires so that they don't touch the skin directly. In fact, only sponges should touch the
patient's body.
11.4 CONTRAINDICATIONS
If the part of the body on which the electrodes must be applied is inflamed, or if we
aren't sure whether we can spare bleedings, do not do any treatments with stimula-
tion current. Consult the responsible physician, before treating patients with implan-
ted electronic devices, such as heart pacemakers or artificial cochlea or with ischemia
at the lower limbs, cardiopathies, epilepsy or pregnant women.
Without this password the function and the pathologies relative are shown but are di-
sabled.
■ For the password contact your distributor.
■ Clicking over the + or with double click over the function name appear the following
under-menu:
+ lower limb
+ pelvis
+ upper limb
+ rachis
+ cellulite
■ Clicking again over the + or with the double click over the under-menu name appe-
ar the other under-menu until it has been shown the protocol name. After this select
the protocol and confirm.
The device is used for shockwave treatment in physical therapy and rehabilitation. For
more details, see the bibliography on the security handbook. The treatment of the pa-
tient has to be made under indication of a doctor and/or authorised personnel.
Expert represents today an innovative system that can give rise to a new and effective
therapeutic approach for the treatment of various pathologies regarding soft tissues
and the skeletal system.
Expert is a system allowing you to perform an innovative methodology called extra-cor-
poreal shock-waves therapy. Expert is a versatile instrument, made for treating both
soft (tendons and muscles) and hard tissues (bone).
The thrust implemented by the end side of a suitable applicator, that the operator has
to put in contact with the suffering region, gives rise to small impulses with high inten-
sity that are transmitted into the tissue. This originates a resonance phenomenon cau-
sing antalgic processes, reduction of local phlogosis, new formation of blood vessels,
reactivation of reparative processes.
Although the unit Expert and its application technique are a sort of derivation and
adaptation of the shock wave therapy already used (particularly in urology for the tre-
atment of the renal calculosis and then in orthopaedics for the treatment of pseudoar-
thorsis), it represents for the physical therapy a novelty because of the lower energies
employed and the therapeutic modalities that can take place in an ambulatory allowing
22 to avoid any anaesthesia or sedation and furthermore any radiographic and/or ultra-
sound visualisation and/or monitoring system.
All these features make the Expert system a specific instrument for the treatment of pa-
thologies into the Physical Therapy and Orthopaedics field. The antalgic, osteo-inducti-
ve and vascular effects allow the treatment of a wide range of tendinous pathologies,
but also allow the activation of processes involving the re-absorption of calcifications,
especially when they are localised in the smallest joints, and help to increase the repa-
rative processes (osteogenesis) in osteo-articular pathologies and fractures.
A large liquid crystal display, where all the information are shown, together with the
availability of function keys and the help on-line, make Expert an extremely easy to use
apparatus.
The technology that uses microprocessor control, in fact, gives the operator the oppor-
tunity of modulating widely the different available parameters. In addition to the num-
ber of shocks, the operator can set the frequency and the Energy Density. Besides the
manual setting, the Expert system has got a series of pre-set therapeutic protocols
(whose values can be varied anyway by the operator according to the seriousness of
the pathology and the feeling of the subject under treatment) and a memory for sto-
ring customised treatments. In such a context another peculiarity of the Expert system
is the opportunity of setting in the same session different steps, having powers and fre-
quencies progressively higher or lower.
WORNING
Be very careful that the unit is switched OFF when removing
the terminal part of the applicator, otherwise the bullet
contained within the applicator can be expelled with violence
and cause serious lesions.
Put your hand over the metal part of the top of the probe and turn the top until to take
it out.
Put the top of the probe into a cartoon. Be care about the packaging in order to avoid
any damage during transport and send it to your nearest distributor.
Or, if you wish, ask for the technical service of your nearest distributor.
b. Place the second top you got as standard accessory over the probe.
Do as follows:
24
c) Clean inside by using the special brushes you got as standard accessories.
We suggest disinfecting accurately the applied part that has to be placed in contact
with the patient, before performing every treatment.
WORNING
The missed cleaning of the unit or the use of non-suitable
solvents can cause the premature deterioration
of the painting and serigraphs.
Check frequently the state of wear and tear of all the cables
(Elettronica Pagani gives only supply cables with quality mark).
12.2 CONTRAINDICATIONS
Concerning treatment with the extra-corporeal shock-waves, some contraindications
are also present.
Absolute contraindications:
■ pregnancy in progress
Relative contraindications:
■ acute inflammation with high tenderness of the area to be treated
following precautions:
Use gel on the treated area in order to reduce the probability of allergic reactions and
to put the flow of the probe.
Use gloves when handling the applicator.
WORNING
Treatments over the cranium and over the back or onto
other regions of the body that can suffer from the applications
of a repetitive series of strokes (such as trachea, thorax, etc.)
must be absolutely avoided.
■ Class of protection: I
■ Pre-set protocols
■ Dimensions: 127x70x70 cm
26
ø 36 mm ø 18 mm ø 6 mm, ø 8 mm, ø 10 mm ø 40 mm
■ Fuse: T6,3A
13.3 CONTRAINDICATION
The TRC not is indicated for the following case:
■ infections,
■ deficit of sensibility (for which the patient don’t perceive or communicate the feeling
of an eventual pain)
■ coagulopatie
■ thrombophlebitises.
■ morbo of Parkinson,
■ neoplasie.
Precaution goes used in the treatments to cervical level where the modified conditions
of the blood circulation can provoke light dizziness.
Time to time and using the capacitive electrode the doctor can use the TRC, even if the
patient have a metallic prosthosis
During the treatment can happen that the pain increasing, in this case it is better to de-
crease the output power and the duration of the application. If the problem persist it
need to interrupt the application and to consult the doctor who has prescribed the tre-
atment.
If the patient after the treatment have irritations, it need to suspend the treatment and
28 to ask to medical staff in order to what to do.
13.4 APPLICATORS
ATTENTION!
Do not remove
the neutral plate
Neutral Electrode
during the
treatment
29
30
All the pathologies have two steps. From the first step to the second one the unit check
the applicator. So if the “modality” parameter is setting on RES (resistive applicator)
and the capacitive applicator is connected then the unit goes in alarm, the timer stop-
ping and on the screen appear the message insert the right applicator, in our case the
Res applicator (see the picture)
Connected the right applicator the unit start from the second step
■ Standard accessories: wheeled frame device with arm, HF detachable cables, conical
f)
d)
c) e)
b) a)
15.0 WARRANTY
The guarantee covers all the defects of materials and workmanship for TWO YEARS,
starting from the purchase date, while for all laser sources, all optical parts, filter, mir-
ror is SIX MONTHS, if not differently agreed.
If the unit did not work properly during the guaranteed time, Elettronica Pagani would
repair it. No charge is made for repair; in fact, the guarantee includes the cost of spa-
re parts and labour, expect for the following conditions:
Guarantee is valid only if the identification data (model, mark and technical features,
etc) are present on the unit.
Elettronica Pagani will repair only breakdowns. Costs and risks during removal, tran-
sport and installation aren't covered by the guarantee.
Elettronica Pagani or technical assistance centres authorised by Elettronica Pagani must
make all repairs. If non-authorised personnel carry out repairs, guarantee is automati-
cally invalid.
Guarantee does not cover periodic checks, calibrations, maintenance and modifica-
tions.
Guarantee isn't valid when:
■ damages have been caused by accidents, carelessness, modifications, use of non ori-
18.0 CLASSIFICATION
33
19.0 WORKING AND STORING CONDITIONS
20.0 BIBLIOGRAFY
Massimiliano Cossu, Elettroterapia basi fisiologiche e applicazioni cliniche, Ghedini Edi-
tore Milano,1991.
Vittorio Alfieri, La stimolazione elettrica terapeutica nel trattamento di: Neurolesioni
centrali, Dolore, Scoliosi, Ghedini Editore Milano,1990.
E.B.Clayton, P.M.Scott, Elettroterapia e Attinoterapia, Casa Editrice Ambrosiana Mila-
no, 1977.
Piero Farneti, Terapia fisica e riabilitazione, Pubblicazione A.Wassermann s.p.a. Mila-
no,1964.
A. Zauner Gutmann, Terapéutica Ultrasónica, Barcellona 1988.
Franco Bistolfi, Campi magnetici in medicina - Biologia, Diagnostica, terapia, Seconda
edizione, Edizioni Minerva Medica, Torino 1986.
“Elettromagnetoterapia a contatto” - Fascicolo della Thelf System
“La magnetoterapia nella pratica clinica ed ambulatoriale” - Estratto da Minerva Medi-
ca 1982
“Esperienza nell’uso delle onde elettromagnetiche come complemento al trattamento
delle pseudo artrosi ed ai ritardi di consolidazione” - Centro Traumatologico Ortopedi-
co di Torino
“Elettromagnetoterapia nel trattamento dei ritardi di consolidazione e pseudoartrosi
anche infetti” - C.T.O. Torino.
“Il grosso braccio postmastectomia” - Estratto delle tecniche mediche, chirurgiche e fi-
34
sioterapiche
“Applicazioni terapeutiche della elettromagnetoterapia Thelf- System in traumatologia
sportiva” - Medicina dello sport
“L’elettromagnetoterapia nel trattamento degli edemi post-traumatici e degli emato-
mi” - C.T.O. Torino
“Applicazioni pratiche dell’utilizzo della diatermia nelle patologie della spalla” di G.
Bernabei e E. Pecchioli
“Applicazioni pratiche dell’utilizzo della diatermia nelle patologie del ginocchio” di G.
Bernabei e E. Pecchioli
Terapia Fisica “ nuove tecnologie in medicina riabilitativa” di A. Zati e A Valent
Piero Farneti, Terapia fisica e riabilitazione, Pubblicazione A. Wassermann S.p.A. Mila-
no, 1964.
Chaussy C., Eisenberger F., Wanner K., Forssman F., Hepp W., Schmiedt E., Brende W.
Seemann O., Rassweiler J., Chvapil M., Alken P., Drach G.W.
Therapy with radial ESWT combined with physiotherapy in the treatment of soft tissue
diseases
J. Crupnik
Radial shock wave therapy (RSWT) for the treatment of chronic tendonopathies – our
experience
P. Kertzman, J. E. Fukugawa
Treatment of chronic lumbar pain with radial shock waves
L. Hernandez
The use of shock waves for the destruction of renal calculi without direct contact
Urol. Res., 1976. 4: p.175
Chaussy C.
Extracorporeal Shock wave lithotripsy
1982, Basel: Karger
Iro H., Schneider H., Födra C., Waitz G., Nitsche N., Heinritz H.H., Benninger J., Ell C.
Shockwave lithotripsy of salivary gland stones
Lancet, 1992. 339: p. 1333-1336
Sauerbruch T., Delius M., Paumgartner G., Holl J., Wess O., Weber W., Hepp W., Bren-
del W.
Fragmentation of gallstones by extracorporeal shock waves
New Engl. J. Med., 1986. 314: p.818-822
Sauerbruch T., Holl J., Sackmann M., Werner R., Wotzka R., Paumgartner G.
Disintegration of a pancreatic duct stone with extracorporeal shock waves in a patient
with chronic pancreatitis
Endoscopy, 1987. 19: p. 207-208
Haupt G., Haupt A., Gerety B., Chvapil M.
Enhancement of fracture healing with extracorporeal shock waves
J. Urol. 1990. 143: p. 230A
Haupt G., Haupt A., Ekkernkamp A., Gerety B., Chvapil M.
Influence of shock waves on fracture healing
Urology, 1992. 39: p. 529-532
Graff J., Richter K.D., Pastor J.
Effect of high energy shock waves on bony tissue 35
High energy shock waves in the treatment of delayed and nonunion fractures
Internat. Orthpaedics (SICOT), 1991. 15: p. 181-184
Burger R.A., Witzsch U., Haist J., Karnosky V., Ahlers J., Hohenfellner R.
Extracorporeal shock wave therapy of pseudarthrosis
J. Urol., 1992. 147: p. 260A
Burger R.A., Witzsch U., Haist J., Karnosky V., Hohenfellner R.
Extracorporeal shock wave therapy of pseudo-arthrosis and aseptic osteonecrosis
J. Endourol., 1991
Schleberger R., Senge T.
Non-invasive treatment of long bone pseudarthrosis by shock waves (ESWL)
Arch. orthop. Trauma. Surg., 1992. 111: p. 224-227
Rompe J.D., Rumler F., Hopf C., Nafe B., Heine J.
Extracorporeal shock wave therapy for the calcifying tendinitis of the shoulder
Clin. Orthop., 1995. 321: p. 196-201
Haist J., von Keitz-Steeger D.
Shock wave therapy in the treatment of near to bone soft tissue pain in sportsmen
Int. J. Sports Med., 1996. 17: p. S79
C. Leal, JC. Lopez, JM. Herrera, OE Reyes, M. Cortes
Radial or focused shockwave biosurgery in lateral epicondylitis
G. Verrati
Extracorporeal shockwave therapy for the treatment of plantar fascitis – comparative
36 study of focused ESWT versus combined focused and radial ESWT.
L. Gerdesmeyer, H. Gollwitzer, P. Diehl
Radial Extracorporeal shock wave therapy (RESWT) induces bone formation in vivo
Skordis D. PH, Papaioannou N. MD, Macheras St. MD, Karalis Th. PH, Dekoumes E: PH,
Tsalkitzi M. PH.
Radial shockwave therapy for the treatment of rotator cuff rupture and pericapsulitis:a
case report
Angelo Cacchio, Marco Paoloni, Antonio Barile, Romildo Don, Fosco de Paulis, Vittorio
Calvisi, Alberto Ranavolo, Massimo Frascarelli, Valter Santilli and Giorgio Spacca
Effectiveness of radial Shock-Wave Therapy for Calcific Tendinitis of the shoulder: Sin-
gle-Blind Randomize Clinical Study
G.Spacca, S. Necozione, A. Cacchio
Radial Shock wave Therapy for lateral Epicondylitis: A prospective randomised control-
led single- blind study