You are on page 1of 34

USER MANUA L ROLAND2

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

4.0 SWITCHING-ON

■ From the back side of the


unit, press ON/OFF button ■ The unit is loading software of ROLAND2 device

Wait just few seconds ...

■ For the first installation it need to set the language

■ Move the ar-


row shown on
display over the
language that
4
you want

■ Press the Y key


to select and then
press OK

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

5.0 MAIN MENÙ


... THE FOLLOWING LCD WILL APPEAR

■ From menu choose the application move the


track-ball to the desired function, then press Y
key to confirm

■ Move the cursor by using the track-ball for set-


ting the required parameter
Press Y key for choosing

■ Set the value by using + and – keys (if you kee-


ping press the key the value change very fast)

■ After having set each parameter press > key


for starting the treatment session

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

6.0 6. USING A PRE-SET PROTOCOL

From the Menu “Applications setting”, move the cursor over the
label “Pathologies/Program” and a full list of pre-set pathologies
will appear.

■ Move the cursor over the


desired pathology by using
the track-ball

One the left side of the


LCD the interested part
of the body to be treated
is shown.
6
■ Press the following keys Y and confirm for
setting

■ All the pre-set and suggested parameters will be displayed

■ Set each parameter


as you already know
and press > key for
starting treatment
session

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

7.0 MEMORY ENTERING

■ 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

do as you already know from the above


mentioned paragraphs ...

■ Press “Save” and over the LCD a special


keyboard will appear for entering the name
of the selected memory.

■ Move the cursor over each word by using


the trackball and press Y for setting up to
the name configuration. As soon as the
name has been completed, you may
a. save the memory by moving the cursor 7
over Save and exit;
b. adding new steps to the already required
function by moving the cursor over “Save
and add”. On this opportunity, you can
■ For using a customised memory, go to save all the steps you need. For entering
the Menu Applications setting”, set Memo- the protocol into the memory, press Save
ries and move the cursor over the name of and Exit.
the protocol you previously entered
■ Move the cursor over the memory and

press Y and then confirm.


■ Start the treatment as usual

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

8. HEALTH THERAPY LASER UNITS (FIBER AND MLT MODELS)


The laser unit here considered is supposed for a therapeutic use and for a direct irra-
diation of parts of the human body with infrared laser radiation. The treatment of the
patient has to be made under indication of a doctor and/or authorised personnel.
FIBER and MLT laser devices are provided with the best technological solutions both in
terms of laser sources and in terms of available operations. For both the units Elettro-
nica Pagani is applying all the best operations coming from Windows CE platform, such
as the availability of a wide range of records to be stored into the memory, both for cu-
stomised and pre-set parameters; very fast up-grading is made by changing flash-card
during life time of the unit; availability of a wide range of parameters over the same
screen.
On the other hand, laser sources are the real and most effective part of the unit: all of
them are solid state sources, also the 1064 nm is replacing at all effects the old 1064
nm Nd;YAG crystal plus neodymium. In fact, the new solid state 1064 nm source is
granting the same deep, the same absorption from the human tissues, the same ope-
rations in continuous, pulsed and super pulsed modes and it also more safety, reliable
and cheaper

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

8.1.1 FIBER MODELS


FIBER laser is provided with a solid state laser source that the operator may choose
among 808 nm infra-red at 5 W or 10 W and 1064 nm at 15 W. All the available laser
sources may work in continuous, pulsed (or interrupted continuous) and super pulsed
emission modes. FIBER device is suitable both for manual applications by using 2 and
6 cm applicators and also static applications over quite big areas of the body by using
12 cm applicator. Every applicator is made with reference to divergence property of la-
ser source and it is properly calculated with reference to the dimensions of the laser
beam at a certain distance.
Available generators:
■ 808 nm Infra-Red source at 5 W, working in continuous, pulsed and super pulsed

emission modes

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

■ 808 nm Infra-Red source at 10 W, working in continuous, pulsed and super pulsed

emission modes
■ 1064 nm source at 15 W, working in continuous, pulsed and super pulsed emission

modes

Probes Technical features


■ 2 cm and 6 cm of diameter Wavelength: 808nm or 1064 nm
Frequency: da 1 a 10Hz step1
da 10 a 50Hz step5
da 50 a 100Hz step10
da 100 a 250Hz step50
Emission cont, pulsed, super pulsed
Peak power: 5W or 10W
15 W for Nd:YAg
Divergency: 250 mrad
Duty Cycle 10% to 90%
Time length from 1 to 59 min
Interlock
DNRO con tempo di esposizione 10s 3,48 m
D.O. 3,19
10
Laser class IV
Password +-+

Super pulsed function is available only with 2 cm applicator

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

Available applicators

Probe Ø 20mm for manual treatment

Probe Ø 60 mm for manual and static treatment

Probe Ø 120 mm for static treatment (optional)

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

8.1.2 MLT Models


Mod. MLT: Multilayer Laser Therapy (laser) continuous, pulsed and super pulsed emis-
sion. It is possible to choose between scan or manual mode.
While scanning mode has been selected, automatically MLT device is choosing conti-
nuous or pulsed emission modes; otherwise, while manual applications is selected, MLT
is avoiding continuous emission mode and allows pulsed and super pulsed emission
modes only. The first choice in scanning mode is made since super pulsed mode should
be too low and application should be very large; otherwise, when manual treatment is
made, it is really impossible to perform any treatment in continuous due to the high
energy delivered from the unit. This is why the unit itself is avoiding continuous emis-
sion mode while using manual treatment.
In manual mode it need to use one of two the following probes 2 cm or 6 cm of dia-
meter. It is possible to put only one MLT module.
Available generators:
- 650 nm visible beam + 1064 nm at 15 W, working in continuous, pulsed and super
pulsed modes
650 nm visible beam + IR 808 nm at 15 W, working in continuous, pulsed and super
pulsed modes
650nm for visible beam + IR 808 nm at 12 W + 1064 nm at 15 W, working in conti-
nuous, pulsed and super pulsed emission modes

12
Probes Technical features

■ 2 cm and 6 cm of diameter Peak power 27 W per MLT3


15 W per MLT808 e MLT1064
Frequency from 1 to 10Hz step1
from 10 to 50Hz step5
from 50 to 100Hz step10
from 100 to 250Hz step50
DNRO exposition time 10s 3,48 m
D.O. 3,19
Divergency: 250 mrad
Time da 1 a 59 minuti
Interlock
Class IV
Password +-+

Super pulsed function is available only with 2 cm applicator

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

Generator

Parameters
[
■ Enter the password made by pressing + - + keys every time you switch the unit on.
■ Press OK for confirming
14

■ Setting and operation are well up to the above mentioned slides.


■ Start the treatment by pressing the pedal switch.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

8.2 SPECIFICATION TAG AND LABEL


On each model of the Fiber and MLT is placed one of the following labels, in complian-
ce with art. 6 of the IEC 601-1 rules

15

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

9.0 SYNERGY MODEL


It is the first unit able to deliver both LOW and HIGH frequency magnetic fields and it
is the only unit able to combine the two available frequencies.
Low frequency magnetic field is delivered at a frequency included from 1 to 200 Hz and
the intensity is adjustable up to 100 Gauss (peak).

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.

Probes Technical features


16
■ Solenoid 2 outputs
■ Solenoid ø300mm (optional) Low frequency
■ High frequency radiator Peak intensity: 100 Gauss
■ Couch with 1 or 2 Effective power from 5 to 50 Gauss
solenoids (optional) Modulation : from to 200 Hz
High frequency
Working frequency: 2 GHz
Modulation from 100 to 5000 Hz
Time length from 0 to 60 minutes

10.0 ULTRASOUND MODEL


The unit is used for ultrasound therapy application in physical therapy and rehabilita-
tion. Ultrasounds are the result of the transmission of mechanical vibrations through a
medium. These are not random vibrations, as in thermal vibration, but orderly oscilla-
tory vibrations generated by an external source. The typical source is a crystal (quartz
or ceramic) driven electrically to vibrate and placed in contact with the outside surface
of the medium, in our case in contact with the body.
Interaction occurs between the source and the particles of the surface of the medium
causing them to vibrate. These particles, in turn, cause their neighbours to start oscil-
lating and so mechanical vibrations pass very quickly through the material.
The consequence is so a considerable increasing of the intracellular exchanges and a
production of diathermal, electrical and chemical effects from which derive the modi-

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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.

10.1 TECHNICAL FEATURES


■ Digitally adjustable treatment time (59 minutes)

■ Acoustic signal at the end of treatment

■ Programmable memory
■ Standard treatment procedures

■ Manual polarity inversion and automatic polarity inversion at half treatment time

■ Two output channels

■ Power supply: 90-260 V 50/60 Hz +/- 10% 17

■ Input power: 150VA

■ Dimensions with trolley: cm 115x44x34

■ Dimensions without trolley: cm 20x28x34

■ Weight: 5kg without trolley

Probes Technical features


■ 1 cm2 multifrequency head Adjustable intensity from 0,1 to 3,0 W/cm2 (max 15 W)
( optional) Emission continuous and pulsed
■ 5 cm2 multifrequency head Working frequency:1, 2, 3 MHz
■ 1 Mhz head for static treat- Modulation: from 10 to 200 Hz
ment ( optional)

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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.

10.3 USE OF GEL


Be sure that, during the treatment, there is always a good contact between transducer
and skin; at this purpose, pay attention to use a sufficient quantity of gel and to place
the transducer correctly.

If transducer-skin contact is not good, EMISSION doesn't ap-


pear on the screen and the REAL TIME device activates an
acoustic signal to inform the operator that the treatment is
not well performed.

10.4. SPECIFICATION TAG AND LABEL


On each model of the Infinity is placed the following labels, in compliance with art. 6
of the IEC 601-1 rules
18

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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)

■ Acoustic signal at the end of treatment

■ Programmable memory

■ Standard treatment procedures

■ Manual polarity inversion and automatic polarity inversion at half treatment time

■ Two output channels


■ Power supply: 90-260 V 50/60 Hz +/- 10%

■ Input power: 150VA

■ Maximum output current:

- for low frequency currents ±76.5 mAp@500Ω per channel


- for middle frequency currents 127mAp@500Ω per channel
- for galvanic currents 24mA@500Ω per channel
■ Dimensions with trolley: cm 115x44x34

■ Dimensions without trolley: cm 20x28x34

■ Weight: 5kg without trolley

The pulse length, frequency and current intensity values are not different from the va-
lues written on this handbook, than more 20%.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

11.2. SPECIFICATION TAG AND LABEL


On each model of the Infinity is placed the following labels, in compliance with art. 6
of the IEC 601-1 rules (see par. 4 in the "Safety and Maintenance" manual for the ex-
planation of symbols):

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.

Electrode Area [cm2] δIM per 76,5mA IM* per 2mA/cm2


dimensions [cm] efficacy [mA/cm2] efficacy [mA]

3,5x4,5 15,75 4,86 3,15


5x5 25 3,06 5,0
4x9 36 2,12 7,2
6x8 48 1,59 9,6
15x20 300 0,26 60

*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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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.

11.5 Info regarding some parameters:


Polarity inversion: POS= Positive; NEG= negative; AUT= automatic
alternating polarity (only for tens)
Channel blocked (only for interferential currents): YES the current of two channels in-
crease/decrease in the same time; NO the current increase/decrease one for time .
Half time: if = 1 the polarity change when the timer is at half of the value setting;
if = 0 is disabled, so the polarity is that of default.
Sound signal (only for pulsed functions): ON enabled; OFF disabled.

11.6 Optional function


■ In the Infinity module if you wish it is possible enable one or more optional function

such us “ISODINAMIC CONTINUOS AND VARIABLE or STIMULATION VENOUS–LYM-


PHATIC”.
■ At these functions are connected some pathologies.
21
■ All optional functions need of the password, (the password have an additional cost).

Without this password the function and the pathologies relative are shown but are di-
sabled.
■ For the password contact your distributor.

■ At the function “stimulation venous-lymphatic”: are connected some protocols that

are shown in the pathologies list.


■ At left of them there is the + symbol.

■ 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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

12.0 EXPERT MODEL

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

12.1 ORDINARY MAINTENANCE


It must be carried out by the operator complying with the suggested times.

Cleaning of the unit and its accessories: (every day)


Cleaning and daily care of the applicator and its parts are fundamental elements to
guarantee a long life to the applicator itself.

FOR THE METALLIC APPLICATOR


Replacement of the shock absorber of the metallic applicator:
We suggest replacing the rubber shock absorber, which is contained into the top of the
applicator, every 15-20 treatments performed with that terminal part.

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.

Replacement of the terminal part of the metallic applicator: 23


We suggest to replace the steel terminal part of the applicator about every 50 treat-
ments performed with that terminal part.

FOR THE FOCUSED APPLICATOR


Replacement of the top of the probe
500.000 shocks

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

2. Cleaning of the gun


500.000 shocks
The probe is made by a cylindrical part where a projectile is moving thanks to the pneu-
matic system. The operator has to clean the above mentioned part in order to grant the
right movement of the projectile which is inside.

Do as follows:

a) Un-screw the alluminium part of the gun.

b) Take out the projectile from the gun.

24

c) Clean inside by using the special brushes you got as standard accessories.

Control of applicators and cables: (at least once in a month)


Remember that damaged or worn-out applicators and cables can cause troubles to the
patient or operator during the treatment and also seriously compromise the correct
working of the unit.
Cleaning and disinfecting applied parts:

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).

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

12.2 CONTRAINDICATIONS
Concerning treatment with the extra-corporeal shock-waves, some contraindications
are also present.
Absolute contraindications:
■ pregnancy in progress

■ cancers in the treatment area

■ alteration of the hematic coagulation

■ assumption of anti-coagulant medicines

■ septic infections of the joints under treatment

Relative contraindications:
■ acute inflammation with high tenderness of the area to be treated

■ significant and widespread osteoporosis

12.3 COLLATERAL EFFECTS


In the clinical practice the following collateral effects can take place due to the appli-
cation of the shock waves therapy: hematomas, oedemas, flaring-up of the painful syn-
drome.
These effects usually vanish within 5-10 days with the application of ice and using lo-
cal anti-inflammatory; shouldn’t this happen then consult a doctor.
If allergic reactions may outcome after the treatment; in particular this can occur to the
patient due to the chromed steel of the terminal part of the applicator or to the ope-
rator due to the aluminium part which makes the applicator, we suggest to take the 25

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.

12.4 IMPROPER USE OF THE UNIT


Although there’s no limits on the age to undergo a treatment, if there are not absolu-
te or relative contraindications; anyway we suggest to avoid shock-waves therapy in
the infantile, puberal and adolescent age in order to avoid harmful meddling in the
bony growth.

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.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

12.5 TECHNICAL FEATURES


■ Power supply: 230 V∼ ± 10% - 50 Hz

■ Power consumption: 1000VA

■ Class of protection: I

■ Applied part: Type BF

■ Compressor’s max. pressure: 8 bar

■ User interface: manual setting

■ Pre-set protocols

■ Activation: through a pedal

■ Dimensions: 127x70x70 cm

■ Weight: about 85 Kg.

Technical features Frequency [Hz] Pressure [mJ/cm2]


Focused Probes From 0.5 to 5 From 0.18 to 0.6
Unfocused and linear probes From 0.5 to 12,5 From 0.18 to 0.36

CONTROLLED FOCUSED MODE UNFOCUSD MODE LINEAR MODE

26

ø 36 mm ø 18 mm ø 6 mm, ø 8 mm, ø 10 mm ø 40 mm

12.6 SPECIFICATION TAG AND LABEL


On each model of the Expert is placed the following labels, in compliance with art. 6
of the IEC 601-1 rules

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

13.0 TRC MODELS


TRC Resistive-Capacitive Diathermy unit is a device capable to induce tissue bio-stimu-
lation through an high frequency (0.5 MHz) modulated Electromagnetic field. The prin-
ciples are well known since the beginning of the XX Century but only in more recent
years the technology developments have afforded the introduction of the method into
the clinical practice under the most appropriate patient and operator safety standards.
In diathermy depending on the kind of the selected active electrode (Capacitive or Re-
sistive) motion and concentration of ions and electric charges is different.
The device used for Rehabilitation is the Capacitive-Resistive diathermy that synergetic
to the therapeutic massage on the functional combination of muscles and tendons as
well as on the capsulo-ligament structures.
Target of the treatment is non only the biologic recovery of acute or sub-acute inflam-
mation but also the functional rehabilitation that shall be stabilized to enable the sport
activities without further injuries and to the original performance level. To this purpo-
se, the rehabilitation treatment could be associated to a functional evaluation, in order
to assess, together with all the clinical findings, the often defined “postural” factors
that can account for the aetiology of the ostheo-articular pathology, and assist the me-
dical staff to monitor the rehabilitation effectiveness.
Targets and purposes of the rehabilitation treatment are variable and might be mainly
defined as follows:
1. Acute Phase: Biologcal Recovery
27
2. Sub-Acute Phase: Articular Range of Motion, Muscle elasticity, Tissues Tonification
3. Rehabilitation Phase: Functional Recovery
4. Re-Athletization Phase: Treatment for specific sport performances

13.1 TECHNICAL FEATURES


■ Digitally adjustable treatment time (59 minutes)

■ Acoustic signal at the end of treatment


■ Programmable memory

■ Standard treatment procedures

■ Power supply: 230 V 50/60 Hz +/- 10%


■ Input power: 750VA

■ Fuse: T6,3A

■ Dimensions with trolley: cm 115x44x34


■ Frequency:485KHz

■ Weight: 20 kg without trolley

13.2 SPECIFICATION TAG AND LABEL


On each model of the Infinity is placed the following labels, in compliance with art. 6
of the IEC 601-1 rules

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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.

To avoid applications on:


■ women in state of pregnancy,

■ patients with pacemaker

■ 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

Applicator Dimension[mm] use Max Power[W]


RESISTIVE 40; 60; 80 mm di diameter Deep tissues 150 for mod.TRC150
300 for mod.TRC300
500 for mod.TRC500
CAPACITIVE 40; 60; 80 mm di diameter Superficial tissues 150 for mod.TRC150
300 for mod.TRC300
500 for mod.TRC500

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

13.4.1 CONNECTIONS TRC MODELS

TRC300 AND TRC500 TRC150

Connect the neutral


plate how shown in
the picture.

ATTENTION!
Do not remove
the neutral plate
Neutral Electrode
during the
treatment

29

Connect the HF cable how shown in


the picture

Active Electrode (probe)

In order to connect the resistive and capacitive


electrode to the probe it need to do a light pressu-
re along the guide how show in the picture. On the
screen appear the type and dimension of the appli-
cator connected
To take off the electrode from the probe it need to
pull without turn around

Guide to avoid the connection

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

Setting and operation are exactly as per the previous slides


The minimum value of power is 20 W and only in start is possible to increase the po-
wer. For these reason in the parameters list of the pathologies there are two values one
is about the output power and the other one is the advised energy.
It is impossible to change the advised energy , while the power is possible to change
only after the start
The advised energy is only indicative and depend time to time from the patient

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

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

14.0 Endosan (Microwave)


When you start the unit the output power is null (conforming with the microwave par-
ticular rule)
So on display in the parameter list appear the recommended power and out power.
After you press start you can change the out power value increasing to the recommen-
ded value.
(the recommended power is only parameter shown on display but isn’t a real value that
you can change).
ENDOSAN is a modern and innovative micro-waves device capable to deliver both con-
tinuous and pulsed emission micro-waves at the carrier frequency of 2450 MHz.
Thanks to the adjustment of PPS (Pulse Per Second)and the duty-cycle, it is possible to
decide to deliver electromagnetic waves without superficial warm for delivering micro-
waves into the depth.
Microwaves are suitable for treating painful pathologies of the back side and of the
joints (such as cervical, dorsal and lumbago) and rheumatic and degenerative patholo-
gies (such as arthrosis, arthritis) and thanks to the pulsed emission mode they are also
useful for treating recent traumas (such as distorsion, contusion, hematoma, muscular
diseases)
■ Emission mode: continuous and pulsed

■ Duty-cycle: adjustable from 25 to 75%

■ Intensity: adjustable up to 250 W

■ Peak: 1600 W (pulsed emission mode)


31

■ Standard accessories: wheeled frame device with arm, HF detachable cables, conical

radiator 170 mm (“a”)


■ On request: radiator “b” (cm 10x12), radiator “c” (cm 17x12), radiator “d” (cm

25x12), radiator “e” (cm 47x12), radiator “f”

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:

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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-

ginal spare parts and/or accessories;


■ cables, electrodes, probes, heads and any other accessory subject to deterioration.

Elettronica Pagani reserves the right to introduce changes or improvements without


being obliged to modify any units produced previously.

16.0 MANUFACTURER RESPONSIBILITY


Elettronica Pagani is responsible about safety, reliability, and performance only whether:
assembly, new settings, adjustments, modifies and repairs are carried out only by the
manufacturer or authorised technical staff;
32 the electrical installation in the treatment room complies with the laws in force;
the unit is used in accordance with the operating instructions;
only original accessories are used.

17.0 DIRECTIVES AND RULES


All models was been designed and manufactured in compliance with the 93/42/EEC Di-
rective dated on 14/06/93 and (2007/47/EC)
In particular:
the Enclosure I (essential requirements) of the 93/42/EEC Directive and (2007/47/EC)
has been satisfied;
the whole production process is made according to the Enclosure II of the 93/42/EEC
Directive and (2007/47/EC) (Complete Quality System[1]), for class IIa and IIb units;
the declaration of conformity has been drown up following the enclosure VII procedu-
re of the 93/42/EEC Directive and (2007/47/EC), for class I units.
Furthermore they have been made in compliance with the IEC 601-1 rules and the spe-
cial IEC 601-2-22 rules, and according to the EMC 2004/108/EC Directive, thus it com-
plies the IEC 601-1-2 rule.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

18.0 CLASSIFICATION

Protection against electrical hazards Class I


for devices supplied by external electric
source (ref. IEC 601-1 art. 5.1.a.)
Protection against direct and indirect Type B applied part for 3-Band and
contacts (ref. IEC 601-1 art. 5.2.) Endosan models
Type BF for all the other models
Protection against liquids penetration Common, cover not protected
(ref. IEC 601-1 art. 5.3.)
Security use with inflammable anaesthetic Not suitable using these
mixtures with air or oxygen or nitrogen oxide kind of material
(ref. IEC 601-1 art. 5.5.)
Kind of working (ref. IEC 601-1 art. 5.6.) Continuous
Directive 93/42/EEC and (2007/47/EC)
classification (Enclosure IX - Rule 9) II b

33
19.0 WORKING AND STORING CONDITIONS

Temperature during work: from 15°C to 35°C (from 50°F to 95°F)


in store: from 0°C to 45°C (from 32°F to 113°F)

Humidity during work: from 45% to 75% RH (not condensed)


in store: from 20% to 80% RH (not condensed)

Pressure during work: from 860hPa to 1060hPa


in store: from 860hPa to 1060hPa

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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

Urol. Res., 1988. 16: p. 252


Graff J., Berding C., Beck M.
Transmission of shock waves through bone: ‘Is it possible to treat iliac ureteral stones
with patient in supine position?’, in Shock Wave lithotripsy
J.E. Lingeman, Newman D. Editor. 1989, Plenum Press: New York. p. 115
Ekkernkamp A., Haupt G., Knopf H.J., Pullenberg P., Muhr G., Senge Th.
Effects of extracorporeal shock waves on standardized fractures in sheeps
J. Urol., 1991. 145: p. 257A
Johannes E.J., Kaulesar Sukul D.M., Pierik E.G., Kristelijn M.J., van Eijck G.J., Bras J.
Non-operative treatment of non-unions in bone with extracorporeal shock waves
Eur. Surg. Res., 1992. 24(Suppl.2): p. 24
Johannes E.J., Kaulesar Sukul D.M., Matura E.
High-energy shock waves for the treatment of nonunions: an experiment on dogs
J. Surg. Res., 1994. 57: p. 246-252
van Arsdalen K.N., Kurzweil S., Smith J. Levin R.M.
Effects of lithotripsy on immature bone and kidney development
J. Urol., 1991. 146: p. 213
Effect of low-dose shock wave energy on fracture healing: an experimental study
J. Endourol., 1992. 6: p. 219-223
Valchanow V., Michailow P., Patrashkov T.,
New possibility of HM-3 lithotriptor for treatment of disturbed bone union
In 7th World Congress on ESWL and Endourology, 1989. Kyoto, Japan
Valchanou, V.D., Miochailov P.

MUX506R REV.G DATE 09/07/2012


USER MANUA L ROLAND2

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

MUX506R REV.G DATE 09/07/2012