ULTRASOUND THERAPY

MEDISOUND 1000
MEDISOUND 3000

ULTRASOUND THERAPY
User Manual
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Rev.2.13.A
 DEAR CUSTOMER

THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT YOUR ENTIRE DISPOSAL
FOR ANY ASSISTENCE OR ADVICE YOU MAY NEED

The devices Medisound 1000 and 3000 are manufactured and distributed by

DOMINO s.r.l.
via Vittorio Veneto 52
31013 - Codognè - TV - Italy
Tel. (+39) 0438.7933
Fax. (+39) 0438.793363
E-Mail: info@globuscorporation.com
www.globuscorporation.com

This product has been manufactured according to the technical regulations in force and
is certified according to Directive 93/42/EEC updated by 2007/47 directive for medical
devices, by CERMET Body (authorization n. 0476), in order to ensure the product's safety.

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Summary
TECHNICAL FEATURES....................................................................................................................................................... 7
Device............................................................................................................................................................................ 7
Use conditions............................................................................................................................................................... 7
Diffuser.......................................................................................................................................................................... 7
Power supply:................................................................................................................................................................ 7
Battery........................................................................................................................................................................... 7
EQUIPMENT ..................................................................................................................................................................... 8
INTENDED USE .................................................................................................................................................................. 8
CONNECTIONS................................................................................................................................................................... 9
Device................................................................................................................................................................................ 9
Diffuser.......................................................................................................................................................................... 9
Accessories (rechargeable battery) ............................................................................................................................ 10
LABELLING AND SYMBOLS .............................................................................................................................................. 10
Accessories.................................................................................................................................................................. 11
Device.......................................................................................................................................................................... 11
Panel and keyboard .................................................................................................................................................... 12
Display......................................................................................................................................................................... 12
ALARMS........................................................................................................................................................................... 13
MANDATORY BEHAVIOUR, WARNINGS AND CONTRAINDICATIONS.............................................................................. 14
Mandatory behavior ................................................................................................................................................... 14
Warnings before the use............................................................................................................................................. 15
Warnings during the use............................................................................................................................................. 15
Side effects and contraindications.............................................................................................................................. 15
Contraindications........................................................................................................................................................ 16
MAINTENANCE AND CLEANING ...................................................................................................................................... 16
Maintenance and cleaning of the device.................................................................................................................... 16
Disposal of the device ................................................................................................................................................. 17
INSTRUCTIONS FOR USE.................................................................................................................................................. 17
Turning on/off............................................................................................................................................................. 17
How to execute and start a program .......................................................................................................................... 18
Creating a new program ............................................................................................................................................. 19
APPLICATION MODE ....................................................................................................................................................... 21
ULTRASOUND ACTION MECHANISM .......................................................................................................................... 22
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 Direct contact method ................................................................................................................................................ 22
Immersion method ..................................................................................................................................................... 22
MAIN AREAS TO BE TREATED.......................................................................................................................................... 24
WARRANTY CONDITIONS................................................................................................................................................ 27
EMC TABLES .................................................................................................................................................................... 28

5
Rev.2.13.A
 DEAR CUSTOMER

THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT YOUR ENTIRE DISPOSAL
FOR ANY ASSISTENCE OR ADVICE YOU MAY NEED

The devices Medisound 1000 and 3000 are manufactured and distributed by

DOMINO s.r.l.
via Vittorio Veneto 52
31013 - Codognè - TV - Italy
Tel. (+39) 0438.7933
Fax. (+39) 0438.793363
E-Mail: info@globuscorporation.com
www.globuscorporation.com

This product has been manufactured according to the technical regulations in force and
is certified according to Directive 93/42/EEC updated by 2007/47 directive for medical
devices, by CERMET Body (authorization n. 0476), in order to ensure the product's safety.

6
Rev.2.13.A
TECHNICAL FEATURES

Device
Case: in food grade ABS
Protection level of the case: IP 20
Dimensions 170x220x60
Weight: approx. 1000 gr.
Certifications CE MDD Certificate

Use conditions
Storage and transportation temperature: from -10°C to -45°C
Max. relative humidity: from 30% to 75%
Temperature: from 0°C to 35°C
Max. relative humidity: from 15% to 93%
Atmospheric pressure: from 700 hPa to 1060 hPa
Diffuser emissions:
Model 3000: 2 frequencies of emission 1 - 3 MHz
Model 1000: 1 frequency of emission 1 MHz

Diffuser
Diffuser: Head of Ø 4.2 cm.
Emission: Continuous, pulsed
Duty Cycle: 10%-100%
Maximum power: 3 W/cm² (+/- 20%)
Protection level of the handpiece: IP 68

Power supply:
Brand Alpha Elettronica
Type AC/DC
PRI: 115.230 Vac 50-60 Hz 1.2A
SEC: 18 V 6,5 A Max
Model SWD 120 T 418 D

Battery
Battery pack: Ni-MH 12V 4 Ah

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EQUIPMENT

E
C

D
A: Carrying case
B: Ultrasound Gel
C: Power supply
D: SD4 Device
E: Diffuser

The device is supplied complete of ultrasound gel, diffuser, carriage case, power supply.
Opening the package, it is necessary to check that the basic equipment is complete. If
some elements should be missing, contact immediately the authorized retailer where you
purchased the product.
Control carefully the integrity of the device and its accessories.
All the supplied information can be modified without previous notice.
The device can be used with some optional accessories (it is possible to see the features
on the website www.globuscorporation.com). If you are interested in buying these
accessories, please contact the retailer.
Accessories not included (available on charge)

- rechargeable battery (Ni-MH 12 V 4Ah)

INTENDED USE

The after sales service is guaranteed for 5 years. We suggest having a check of the device
every two years for the maintenance and to ensure the safety.

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The device can be used continuously when connected to the mains. The numbers of
treatments depends on the battery charge. The duration of the battery is 6 months, we
suggest replacing it after that period.
The Medisound 1000 and 3000 are not intended for domestic purposes and are designed
to be used in the following operating environments:
- clinics;
- physiotherapy centers;
- rehabilitation centers;
- general pain treatments (medical treatments);

The use of the device is permitted to doctors and physiotherapists.

CONNECTIONS

Device
Power supply by electricity grid. The Medisound 1000 and 3000 can operate connected
to the mains (the rechargeable battery is an accessory available on charge). To connect
the power supply to the connector, plug it as shown below.

Diffuser
To connect the diffuser to the device, plug the connector in the intended inlet in the
back part of the unit (see picture).
ATTENTION: Do not unplug the diffuser if the unit is working

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Accessories (rechargeable battery)
The device can be charge with a set of rechargeable nickel-metal hydrate batteries
(7.2V, 1.5Ah), which have high performance without storage effect (the rechargeable
batteries are an optional accessory).
Recharge the batteries when the battery light on the display indicates ¼. To charge the
batteries, turn off the device and disconnect the diffuser, then connect it to the power
supply by inserting the plug in the appropriate inlet (see picture).
Do not use a power supply different from the one provided with the device. To replace
the device's batteries, contact an authorized service center.

LABELLING AND SYMBOLS

Warning
This symbol on your device indicates that it complies with the
directives on medical devices (93/42/CEE 47/2007CEE). The number
of the notified unit is 0476.

It indicates that this is a II class device.

It indicates that this device has BF type parts.

WEEE symbol (Waste of Electrical and Electronic Equipment).

Recycling symbol. Recycling symbol.
The WEEE symbol used for this product indicates that the device may
not be disposed for as a household product. Properly dispose of the
product to help protect the environment. For more information on
recycling this product, contact the local competent department,
the household waste management company or the store in which
the product was purchased.
It indicates that the product has been produced respecting the
directive 2002/95/CE.

It indicates the optimal temperatures for the storage and

transportation of the product.
It informs the operator that before using the device he must read the
manual.

IP20 It indicates the water protection degree

It informs the operator of a compulsory conduct

It refers to the pressure of the environment where the device and its
accessories are stored and shipped

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 It refers to the humidity of the environment where the device and its
accessories are stored and shipped
It refers to the manufacturer

It refers to the expiry date

It refers to the production lot

Polythene symbol

Input:
Input
It indicates the value of the mains voltage for the power supply
Output:
- it indicates the power supply outbound voltage
- it indicates the maximum power value of the magnetic field
Output
emitted by the device
- it indicates the range of frequencies of the magnetic field emitted
by the device
Type It indicates the device type

Power It indicates he power supply model of the device

Battery It indicates the battery pack inside the device

PRI Mains voltage

SEC Power supply voltage

Accessories

Device

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Panel and keyboard

UP/DOWN button: to increase and decrease the power

ON/OFF/OK Button: to switch on, off and to confirm the treatment
Fn (Function) button: to change the power visualization
* Time Button: To modify the duration of the treatment
LEFT/RIGHT button: Buttons to navigate/ to return to the main menu
P+/P- Button: Button to select the menu, the area and the program

Display

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ALARMS

Certifications CE MDD Certificate

The sound and acoustic signals are in compliance with directive 60601-1-8.

Meaning

Correct power emission The treatment proceeds

correctly

Cable not connected Check that the cable is

connected to the right
output.

Device in pause Press OK to continue the

treatment.

No contact Check that gel is present on

the hand of the handpiece

No contact disabled It indicates that the contact

control has been disabled

NOTE:
In case the window of not connected cable should appear, verify that the device cables
and the diffuser are integral and correctly used.
If the problem should persist contact the service centers.

Contact control (no contact)

It is possible to disable the contact control (symbol is shown on the upper right corner of
the display) up to the end of the ongoing treatment by pressing for more than 3 seconds
the Fn button. To enable the control again, press the "Fn" button for more than 3 seconds.

Overheating alarm (hot)

Red led lights up + "hot" + 3“ sec. blip is appearing on the display: it means that either the
head or the device are overheating. The device goes automatically in pause and the
yellow led lights up.

Problem solution for overheating head

Add gel on the head or immerse the head into water to cool it down. When the red led
turns off, it is possible to continue the treatment by pressing the OK button. Problem
solution for overheating device Check that the internal fan has automatically turned on

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and wait for the red led to turn itself off. It is possible to continue the treatment by pressing
the OK button.
- If the Red led is still on after trying these 2 solutions, turn off the device and wait a few
more minutes. Turn on the device.
Is the red led still on?
NO. The problem is solved. Use the device as usual.
YES. Contact the service centers.

Luminous signals

On/off indicator

PAUSE indicator (during the treatment)

General error indicator. If the led turns on, check the connections between the
cables and the electrodes. If the led is still on, contact the service centers.

Power level indicator

MANDATORY BEHAVIOUR, WARNINGS AND CONTRAINDICATIONS

Mandatory behavior
For safety reasons, the device must be used in the prescribed manner and within the limits
of use explained in this manual.
The manufacturer declines any responsibility due to a different use from what it is
indicated in this manual.
No part of this manual (texts and/or photos) may be reproduced by electronic or
mechanical means without the prior written authorization of the manufacturer.
If the package, the cable or the connector of the power supply show signs of wear or
damage, replace it instantly.
The unit should be connected to the mains by its power supply. Before starting the
treatment, make sure that the power system specifications comply with the directives in
force within your country. Make sure that the power supply will be in a comfortable
position and that it will be easy to be removed.
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Warnings before the use
We suggest to avoid the use of the device together with other electronic devices,
especially with those used to maintain vital functions. For a correct use of the
Electromedical device, make reference to the tables attached. If it is necessary to use
the device near or together with other devices, pay attention to its working.
- It is recommended to read carefully the entire operating manual before using the
device; keep carefully this manual.
-The unit must be used only with the diffusers provided with the original equipment
(Globus brand) and according to the therapeutic modalities described in this manual.
-Before each use always check the integrity of the unit. This is a fundamental requirement
for carrying out therapies, do not use the unit if either the buttons or cables are defective
or malfunctioning.
The device:
-once you have turned on the device, make sure that in the display the software version
and the model of the device appear, it means that the device is working and it is ready
to be used.
If not, or in the display all the segments do not appear, turn it off and on again. If the
problem persists, contact the service center and do not use the device.
- An unexpected switching-off of the device means that the battery has run-down.
Charge it according to the instructions in the paragraph: HOW TO CHARGE THE BATTERIES
(this can happen if the Medisound 1000 or 3000 are working using the battery pack
purchased as optional accessory).

Warnings during the use

The devices Medisound 1000 and 3000 are planned for a continuous use
When using the Medisound 1000 and 3000, some warnings should be followed:
- In case of damaged cables, they must be replaced with original parts and not used
anymore.
- The device must be kept out of the reach of any pet that could damage it and
contaminate it with parasites.
- The cables of the device, the diffusers and the power supply should not be wrapped
around people's neck to avoid any risk of strangulation and suffocation.
- The mobile and fixed radio communications devices could influence the functioning of
the electromedical device: see the tables attached to this manual.

Side effects and contraindications

Possible side effects
It has been observed isolated cases of skin irritations in people with high skin sensitive.
In case of allergic reaction to the gel, suspend the treatment and contact the specialist.

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Contraindications
Do not use ultrasound in the following cases:
- patients with cancer diseases because ultrasound could favor the proliferation of tumor
cells;
- on hematomas;
- conditions, such for example thrombophlebitis, in which the ultrasound administration
can cause emboli ruptures;
- Areas affected by acute sepsis should not be treated with ultrasound because of the
danger of the diffusion of the infection;
- The radiotherapy produces an opposite effect on tissues, therefore ultrasound should not
be used on areas under radiations before that six months have been passed from the last
radiations;
- Osteoporosis because it could favor the decalcification. This is not an absolute
contraindication, see your physician for more information;
-Articulations with epiphysis during the bone growth phase.
- On ocular area and near it;
- During pregnancy and the menstrual cycle in the abdominal and lumbar areas;
- Do not use near glands and heart.

MAINTENANCE AND CLEANING

Maintenance and cleaning of the device

- In case of real or alleged malfunction, do not tamper with the device or try to repair it by
yourself.
Do not intervene on the device and do not open it. Only specialized and authorized
centers can repair it.
- Avoid violent impacts that may cause damage and malfunctions to the device even if
undetectable immediately.
- Use this device in a dry environment and in an open space (not wrapped in any
materials).
- Clean the device and its accessories only with disinfectant with sodium hypochlorite or
quaternary ammonium salt diluted with distilled water equal to 0.2-0.3%. After
cleaning/disinfecting it, dry the device and its accessories with a clean cloth.
- Use always the device and its accessories with clean hands.
- It is recommended to use the device in a clean room, to avoid the contamination of the
device with dust and dirt.
- It is recommended to use the device in a ventilated space, with regular air change.
- It is recommended to clean/disinfect the parts after every use.
At every cleaning and/or disinfection of the treatment head and in any case at the end
of every treatment it is necessary to check that it does not present cracks or fissures that
could permit the entry of conductive liquid.
If the treatment head presents cracks or fissures, replace it immediately.
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Handle with care the treatment head. An inappropriate handling can modify its
performance.
The maintenance of the device should be made every 24 months, contact the
manufacturer for information about the maintenance process.

Disposal of the device

Do not throw the device or part of it in the fire, but dispose of the product in the
specialized centers and respecting the directives in force in your country. When the
product has to be disposed of, the user can give it back to the retailer when purchasing a
new unit.
A correct separate waste collection or following what above mentioned contribute to
avoid possible negative effects on environment and health and promote the reuse
and/or recycle of materials of which the device is composed. The illegal disposal of the
product by the user involves the application of the administrative fines according to the
current regulations.

INSTRUCTIONS FOR USE

AUTOMATIC CALIBRATION OF THE HANDPIECES

Every time the device has been turned on, it automatically calibrates the head that must
be always clean and used in an open space.

Turning on/off
Connect the device to the mains.
To turn on or off, press and hold the On/Off (OK) button until an acoustic signal is heard.
The animation will appear.
Program selection

Select program list by using the P+ and P- buttons. Press the OK button to confirm your
choice.

Depending on the model, the following areas are displayed:

Model 3000:
- MY PROGRAMS (restricted Area for new programs)
- HEALTH
- AESTHETIC

Model 1000:
- MY PROGRAMS (restricted Area for new programs)
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- HEALTH

Step 1 - Area selection:

Using the P+ and P- buttons, place the cursor on the area you want to select. Press OK to
confirm.

Step 2 - Body part selection (only in the AESTHETIC-FITNESS area)

Using the P+ and P- buttons, select the body part you want to treat and confirm with OK.

Step 3 - Desired program selection

Select the desired program by using the P+ and P- buttons. Press OK to confirm.

How to execute and start a program

After selecting a program, the display shows the start screen where the following
elements are showed: the name, the symbol of mains supply (or the battery charge state,
if not connected to the mains), the total time, the duty cycle %, the frequency value of
the head and the emitted power value.
To start the program, press the OK button and regulate the output power (Watt) with the
Up and/or Down buttons.

How to pause the program

To pause the program, press the OK button, the power will zero. Time stops. Press OK
again to return to the execution of the program. During the pause the message PAUSE will
appear on the screen.

How to stop the program

To stop the program hold down the OK button until a beep is heard.
It appears the screen that asks for the releasing the OK button to turn off the device.

How to change the phase time

To activate the phase time modification press the * button and use the P+ o P- buttons.
After the regulation, press again the * button.

How to increase and decrease power

To activate the power modification press the UP/DOWN buttons.
Modifying the visualization of the power measurement unit
The device permits to visualize the power value emitted in two modalities:
1 - Watt
2 - Watt/cm2
To change the visualization press the Function fn button, while a program is executing.

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Creating a new program
The 1000 and 3000 versions permit the creation of 30 programs, all programs can be
named. From the main menu, using the P+ and P- buttons select the New program menu.
After highlighting the menu, confirm your choice with the OK button.
It is displayed the following screen that permit to set the program parameters.

By using the P+ or P- buttons move the cursor on the parameter you wish to modify. By
using the UP/DOWN Increase/Decrease Power buttons set the desired value.
The following parameters can be set:
• Frequency
• Emitted power
• Treatment duration
• Duty cycle.
It is possible to create and memorize up to 30 new programs.

How to insert the program's name

To place the cursor oh the space where you want to set the letter/number use the Left
and Right button. Select the letter/number using the UP/DOWN Increase/Decrease
buttons. After selecting the letter/number confirm with the Left/Right buttons and set the
next letters.

After setting the name, confirm with OK. Using the left button, it is possible to return to the
starting menu.

My programs
Inside the area new programs are available.
How to delete a program
Pressing the fn button, it is possible to delete definitely an already created program.

Pressing the OK button, the program is executed.

Settings
Selecting settings, it is possible to access to the following menus:

• Acoustic signals
• Auto shut-off timer
• Contrast
• Language
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ACOUSTIC SIGNALS

If the acoustic signals function is on (ON) the device emits a tone while pressing the
buttons.

It is possible to select one of the two modalities by pressing the P+ and P- buttons. Confirm
with the OK button.

AUTO SHUT-OFF TIMER

It permits to set the time after that the device, if not used, turns off. It is possible to select a
value from 1 to 20 minutes.
The selection is made using the P+ and P- buttons and confirm with the OK button.

CONTRAST

It permits to modify the contrast.

Use the P+ and P- buttons to select and confirm with the OK button.

LANGUAGE

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It permits to modify the language of the menu and the programs.
Use the P+ and P- buttons to select and confirm with the OK button.

APPLICATION MODE

Specific health applications

The therapeutic effects of ultrasound are partly due to the temperature increase. They
consist in analgesia, fibrolytic and trophic effect.
a) Analgesia
The analgesic effect is due to the heat and probably also to a direct action of the
ultrasound on the sensitive nervous terminations.
b) Fibrolytic action
The oscillations of tissue particles produced by ultrasound, determine the disintegration of
the collagen fibers of the fibrous tissues.
c) Trophic effect
The vasodilatation, caused by the thermal elevation, facilitates the catabolic removal
and supplies the tissues of nutritive substances and oxygen; in this way ultrasound
improves the tissue trophism, facilitate the repair of the damaged tissues and accelerate
the resolution of the inflammatory processes.

Specific applications for FITNESS and BEAUTY

- Applications for the absorption of active substances on face and body. The program is
used for the application of cosmetic agents.
The ultrasound facilitates the absorption of oil, fat soluble vitamins, products with
liposome, emulsions and water-soluble agents.
The effect is to increase the permeability of the cells, to decrease the skin functional
barrier and to increase the channel activity of the active ingredients.
- Treatment for surface wrinkles and sensitive skins.
The treatment is used to spread and smooth wrinkles (expression wrinkles). The
ultrasound, thanks to its thermal effects, warms the tissues and favors the metabolic and
biochemists processes.
- Treatment for acne, pimples on face and body.
Beyond to an anti-inflammatory effect the ultrasound activates the fibroblasts that have
an important role in the process of post-inflammatory regeneration. Collagen and elastic
fibers, produced after the ultrasound treatment, increase the tissue elasticity reducing
the possible formation of post-acne scars. It is also possible to favor the absorption of anti-
acne products increasing their effectiveness.
- Treatments anti cellulite.
Ideal for cellulite problems. The thermal effect permits an action of mobilization of fat on
the treated area. In this way it is favored the metabolism of fat and its removal.
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ULTRASOUND ACTION MECHANISM

Mechanical effects: the mechanical action is due to the particles movement of the
tissues crossed by the ultrasonic wave.
Although the movement of the single particles is small, the pressure variations that it
produces are so considerable to generate important mechanical effects on tissues.
The mechanical modifications induced by the device determine:
a) acceleration of the processes of diffusion through cellular membranes.
b) Scission of complex molecules (proteins, polysaccharides., etc.).
c) tissue micromassage
Thermal effects; the passage of ultrasound through "the soft" tissues creates an elevation
of the temperature for:
- absorption due to viscosity,
- absorption due to thermal conductivity and chemical absorption.
The ultrasound produces heat through the vibrations, the collision and the friction of the
cellular and intercellular
structures that compose the tissues, crossed by the sound waves. The thermal elevation
generates, as secondary effects, an increase of the cellular metabolism and
vasodilatation.
Chemical effects: the chemical action with the modification of the local ph, the
permeability of cellular membranes and with molecular changes is caused by the
remarkable accelerating forces to which tissue particles are subjected to the passage of
the ultrasonic wave.

The therapy with ultrasound can be used following two different methods: direct contact,
with mobile head and immersion.

Direct contact method

The direct contact modality consists in the application of the emission head to a skin
direct contact with the interposition of a substance (usually a special conductive gel)
which favors the transmission between the skin and the head, the sliding of the head and
the elimination of possible air placed between the skin and the diffuser, because it could
hinder, for its reflecting capacity, the transmission of the ultrasonic waves.

Immersion method
It is useful when the areas to be treated are too small or irregular or when the area is so
hurting to impede the direct contact.
The area to be treated should be immersed in a container with water together with the
diffuser. The diffuser must be placed at a maximum distance of 2-3 cm from the body
surface in order to avoid an excessive dispersion of the ultrasonic beam that could
decrease the therapeutic effect.
The water temperature has to be about 37°, the lower the water temperature is the more
is the cutaneous heat loss and the less is the therapeutic effect.

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The head can be moved in concentric circles holding the head surface parallel to the
skin surface to reduce the refraction phenomena to the minimum. Common tap water
has the problem that gas bubbles dissociate themselves from the water, they accumulate
on the patient skin and on the treatment head reflect the ultrasound wave. If it is not
possible to avoid the use of common water, it is necessary to frequently remove the gas
bubbles from the surface and to clean up the area of emission of the head at the end of
the treatment.
In treatment with gas water, the attenuation of the ultrasound power is more elevated
than in the direct contact treatment, for this reason more elevated dosage are required.
Instead, when you use no gas water the dosage has to be the same used in the direct
contact treatment.

Recommended intensity
The device starts with a preset intensity of 0.1 Watt/cm2 (0.5 Watt) and can reach a
maximum intensity according to each protocol. The intensity shown in this manual is the
one we suggest for this product and reflect the one that is mainly used in the known
protocols. The physiotherapist is free to use the maximum recommended intensity or to
modify it according to his needs and to the type of treatments and patients.

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MAIN AREAS TO BE TREATED

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 Program list HEALTH - REHAB
(medical treatments)

In compliance with the last regulations of the Ministry of Health, medical treatments are
indicated in the below list
X = Available program
The following programs are medical

Program's name Medisound 1000 Medisound 3000 Recom. power

HIP OSTEOARTHRITIS x x 1 W/cm²
KNEE OSTEOARTHRITIS x x 1 W/cm²
SHOULDER OSTEOARTHRITIS x x 0.8 W/cm²
SPINAL OSTEOARTHRITIS x x 1 W/cm²
ANKLE OSTEOARTHRITIS x x 1 W/cm²
OSTEOARTHRITIS x x 1 W/cm²
PSEUDOARTHRITIS x x 1 W/cm²
WRIST FRACTURE x x 0.3 W/cm²
FATIGUE FRACTURE OF TIBIA x x 0.2 W/cm²
FRACTURES x x 0.3 W/cm²
CARPAL TUNNEL x x 1 W/cm²
EPICONDYLITIS x x 1.5 W/cm²
BACK PAIN x x 1.2 W/cm²
CALCIFIED SHOULDER TENDINITIS x x 1.5 W/cm²
MUSCLE PAIN x x 0.5 W/cm²
CERVICAL PAIN x x 1.5 W/cm²
TRAPEZIUS PAIN x x 1,2 W/cm²
SPINAL STENOSIS x x 1.5 W/cm²
Total Programs 18 18

Because of the presence of clinical programs, this product is a medical device. Therefore
it is certified by the CERMET Body n°. 0476 according to 93/42/CEE directive for medical
devices. The certification covers clinical applications.

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 Program List Aesthetic
(non-medical treatments)

The following programs are not medical

Recommended
Program's name Medisound 1000 Medisound 3000 power
OEDEMATOUS CELL. x 1 - 2 Watt/cm2
FIBROUS CELLULITE x 1 - 2 Watt/cm2
LIPOLYSIS x 1 - 2 Watt/cm2
HYPOTONIA x 1 - 2 Watt/cm2
STRETCH MARKS x 1 - 2 Watt/cm2
ORANGE-PEEL SKIN x 1 - 2 Watt/cm2
SKIN SMOOTHING x 1 - 2 Watt/cm2
LYMPHATIC DRAINAGE x 1 - 1.5 Watt/cm2
MASSAGE x 1 - 1.5 Watt/cm2
SKIN RESTRUCTURE x 0.5 - 1 Watt/cm2
FACE LIFTING x 0.5 - 1 Watt/cm2
"PHOTOAGING" TREAT. x 0.5 - 1 Watt/cm2
ABDOMEN RELAXATION x 1 - 2 Watt/cm2
ABDOMEN ADIPOSITY x 1 - 2 Watt/cm2
FLABBY THIGHS x 1 - 2 Watt/cm2
THIGHS/HIP DRAIN. x 1 - 2 Watt/cm2
THIGHS/HIP MASS. x 1 - 2 Watt/cm2
GLUTEOUS/HIP ADIP. x 1 - 2 Watt/cm2
RELAXATION x 0.5 - 1 Watt/cm2
ARM LYNF. DRAIN. x 0.5 - 1 Watt/cm2
BREAST STRETCH MARKS x 0.5 - 1 Watt/cm2
BREAST RELAXATION x 0.5 - 1 Watt/cm2
WRINKLE TREATMENT x 0.5 - 1 Watt/cm2
SCARE TREATMENT x 0.5 - 1 Watt/cm2
COUPEROSE x 0.5 - 1 Watt/cm2
TELANGIECTASIAS x 0.5 - 1 Watt/cm2
BODY PIMPLES x 0.5 - 1 Watt/cm2
FACE PIMPLES x 0.5 - 1 Watt/cm2
FACE ACNE x 0.5 - 1 Watt/cm2
KELOID TREATMENT x 0.5 - 1 Watt/cm2
ACTIVE PRINCIPLE APP. x 0.5 - 1 Watt/cm2
Total Programs 0 31

CE0476 does not refer to non-medical treatments.

26
Rev.2.13.A
WARRANTY CONDITIONS

The device is guaranteed to the original purchaser for 24 months from the purchase
date against defects of the material or the manufacturing (12 months, if the user
uses the device for professional aim), provided that it is used properly and manteined
under normal operating conditions.

Warranty coverage is limited in the following cases:

- Six (6) months for supplied accessories subject to wear, such as batteries, power
supplies, diffuser, cables , etc.

In order to take advantage of the warranty service, the user must comply with the
following warranty clauses:
1.The products to be repaired must be sent by and at the expenses of the customer in
their original packages.
2.The product's warranty is subject to the production of a fiscal document (fiscal
receipt, receipted bill or sale invoice), attesting the product's purchase date.
3.The repair work shall have no effect on the original warranty expiry date and shall
neither renew nor extend it.
4.If, prior to carrying out the repair work, no defects are found, the costs related to
inspection times shall in any case be charged.
5.The warranty becomes void where the fault has been caused by: impacts, falls,
erroneous or improper use of the product, use of non-original external feeders,
accidental events, alteration, replacement/detachment of the warranty seals and/or
tampering with the product. The warranty does not cover damages caused during
transportation when unsuitable packages are used (see point 1).
6.The warranty does not cover the inability to use the product, other incidental or
consequent costs or other expenses incurred by the purchaser.

Note: Before returning the device for repairs, we recommend to read carefully the user
instructions contained in this manual and to visit Globus website. If you have to return the
product for repair, contact your dealer or Globus customer service. The manufacturer
reserves the right to make all necessary modifications at any time in order to improve the
aspect and the quality of the product.

27
Rev.2.13.A
EMC TABLES

TAB. 201
GUIDA E DICHIARAZIONE DEL COSTRUTTORE – EMISSIONI ELETTROMAGNETICHE – PER
TUTTI GLI APPARECCHI ED I SISTEMI
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS
– FOR ALL EQUIPMENT AND SYSTEMS
MEDISOUND 3000 è previsto per funzionare nell’ambiente elettromagnetico sotto
specificato. Il cliente o l’utilizzatore del MEDISOUND 3000 deve garantire che esso
viene usato in tale ambiente.
The MEDISOUND 3000 is intended for use in the electromagnetic environment
specified below. The customer or the user of the MEDISOUND 3000 should assure
that it is used in such an environment.
Prova di emissione Conformità Ambiente elettromagnetico – Guida
Emissions Test Compliance Electromagnetic environment -
Guidance
Emissioni RF Gruppo 1 MEDISOUND 3000 utilizza energia RF
RF emissions Group 1 solo per il suo funzionamento interno.
CISPR 11 Perciò le sue emissioni RF sono molto
basse e verosimilmente non causano
nessuna interferenza negli
apparecchi elettronici vicini
MEDISOUND 3000 uses RF energy only
for its internal function. Therefore, its
RF emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
Emissioni RF Classe B MEDISOUND 3000 è adatto per l’uso
RF emissions Class B in tutti i locali compresi quelli
CISPR 11 domestici e quelli collegati
Emissioni armoniche Classe A direttamente ad un’alimentazione di
Harmonics emissions Class A rete pubblica a bassa tensione che
IEC 61000-3-2 alimenta edifici usati per scopi
Emissioni di fluttuazioni Conforme domestici.
di tensione/flicker Complies MEDISOUND 3000 is suitable for use in
Voltage all establishments, including domestic
fluctuation/flicker establishments and those directly
emissions connected to the public low-voltage
IEC 61000-3-3 power supply network that supplies
buildings used for domestic purposes

28
Rev.2.13.A
TAB. 202
GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA – PER
TUTTI GLI APPARECCHI ED I SISTEMI
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
– FOR ALL EQUIPMENT AND SYSTEMS
MEDISOUND 3000 è previsto per funzionare nell’ambiente elettromagnetico sotto
specificato. Il cliente o l’utilizzatore del MEDISOUND 3000 deve garantire che esso
viene usato in tale ambiente.
MEDISOUND 3000 is intended for use in the electromagnetic environment
specified below. The customer or the user of the MEDISOUND 3000 should assure
that it is used in such an environment.
Prova di immunità Livello di prova Livello di Ambiente
Immunity Test IEC 60601 conformità elettromagnetico –
IEC 60601 test Compliance level Guida
level Electromagnetic
environment -
Guidance
Scarica ±6 kV a ±6 kV a I pavimenti devono
elettrostatica contatto_contact contatto_contact essere in legno,
(ESD) ±8 kV in aria_air ±8 kV in aria_air calcestruzzo o in
Electrostatic ceramica. Se i
discharge (ESD) pavimenti sono
ricoperti di materiale
IEC 61000-4-2 sintetico, l’umidità
relativa dovrebbe
essere almeno 30%.
Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material, the
relative humidity
should be at least 30%.
Transitori/treni ±2 kV per le linee ±2 kV per le linee La qualità della
elettrici veloci di alimentazione di alimentazione tensione di rete
Electrical fast di potenza_for di potenza_for dovrebbe essere
transient/burst power supply lines power supply quella di un tipico
±1 kV per le linee lines ambiente
IEC 61000-4-4 di commerciale o
ingresso/uscita_for ospedaliero.
input/output lines Mains power quality
should be that of a
typical commercial or
hospital environment.
Sovratensioni ±1 kV linea-linea ±1 kV linea-linea La qualità della
Surge line-line line-line tensione di rete
29
Rev.2.13.A
TAB. 202
GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA – PER
TUTTI GLI APPARECCHI ED I SISTEMI
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
– FOR ALL EQUIPMENT AND SYSTEMS
MEDISOUND 3000 è previsto per funzionare nell’ambiente elettromagnetico sotto
specificato. Il cliente o l’utilizzatore del MEDISOUND 3000 deve garantire che esso
viene usato in tale ambiente.
MEDISOUND 3000 is intended for use in the electromagnetic environment
specified below. The customer or the user of the MEDISOUND 3000 should assure
that it is used in such an environment.
Prova di immunità Livello di prova Livello di Ambiente
Immunity Test IEC 60601 conformità elettromagnetico –
IEC 60601 test Compliance level Guida
level Electromagnetic
environment -
Guidance
±2 kV linea – terra ±2 kV linea – terra dovrebbe essere
IEC 61000-4-5 line-earth line-earth quella di un tipico
ambiente
commerciale o
ospedaliero.
Mains power quality
should be that of a
typical commercial or
hospital environment.
Buchi di tensione, <5% UT <5% 230V La qualità della
brevi interruzioni e (>95% buco in_dip (>95% buco tensione di rete
variazioni di in UT) in_dip in 230V) dovrebbe essere
tensione sulle per_for 0,5 per_for 0,5 quella di un tipico
linee di ingresso cicli_cycle cicli_cycle ambiente
dell’alimentazione commerciale o
Voltage dips, 40% UT 40% 230V (60% ospedaliero. Se
short interruptions (60% buco in_dip buco in_dip in l’utilizzatore del
and voltage in UV) 230V) MEDISOUND 3000
variations on per_for 5 per_for 5 richiede un
power supply cicli_cycles cicli_cycles funzionamento
input lines continuato anche
70% UT 70% 230V durante l’interruzione
IEC 61000-4-11 (30% buco in_dip (30% buco in_dip della tensione di rete,
in UT) in 230V) si raccomanda di
per_for 25 per_for 25 alimentare il
cicli_cycles cicli_cycles MEDISOUND 3000 con
un gruppo di
<5% UT <5% 230V continuità (UPS) o con
(>95% buco in_dip (>95% buco batterie.
in UT) in_dip in 230V) Mains power quality
per_for 5 sec per_for 5 sec should be that of a
typical commercial or
30
Rev.2.13.A
TAB. 202
GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA – PER
TUTTI GLI APPARECCHI ED I SISTEMI
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
– FOR ALL EQUIPMENT AND SYSTEMS
MEDISOUND 3000 è previsto per funzionare nell’ambiente elettromagnetico sotto
specificato. Il cliente o l’utilizzatore del MEDISOUND 3000 deve garantire che esso
viene usato in tale ambiente.
MEDISOUND 3000 is intended for use in the electromagnetic environment
specified below. The customer or the user of the MEDISOUND 3000 should assure
that it is used in such an environment.
Prova di immunità Livello di prova Livello di Ambiente
Immunity Test IEC 60601 conformità elettromagnetico –
IEC 60601 test Compliance level Guida
level Electromagnetic
environment -
Guidance
hospital environment.
If the user of the
MEDISOUND 3000
requires continued
operation during
power mains
interruptions, it is
recommended that
the MEDISOUND 3000
be powered from an
uninterruptible power
supply or a battery
Campo 3 A/m 3 A/m I campi magnetici a
magnetico a frequenza di rete
frequenza di rete dovrebbero avere
(50/60 Hz) livelli caratteristici di
Power frequency una località tipica in
(50/60 Hz) ambiente
magnetic field commerciale o
ospedaliero.
IEC 61000-4-8 Power frequency
magnetic fields should
be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment
Nota_e UT è la tensione di rete in c.a. prima dell’applicazione del livello di
prova
UT is the a.c. mains voltage prior to application of the test level

31
Rev.2.13.A
 TAB. 204
GUIDA E DICHIARAZIONE DEL COSTRUTTORE – IMMUNITÀ ELETTROMAGNETICA – PER GLI
APPARECCHI ED I SISTEMI CHE NON SONO DI SOSTENTAMENTO DI FUNZIONI VITALI
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY –
FOR EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING
MEDISOUND 3000 è previsto per funzionare nell’ambiente elettromagnetico sotto
specificato. Il cliente o l’utilizzatore del MEDISOUND 3000 deve garantire che esso
venga usato in tale ambiente.
MEDISOUND 3000 is intended for use in the electromagnetic environment specified
below. The customer or the user of the MEDISOUND 3000 should assure that it is used
in such an environment.
Prova di immunità Livello di prova Livello di Ambiente elettromagnetico –
Immunity Test IEC 60601 conformità Guida
IEC 60601 test Compliance Electromagnetic environment -
level level Guidance
Gli apparecchi di
comunicazione a RF portatili e
mobili non dovrebbero essere
usati più vicino a nessuna parte
del MEDISOUND 3000 compresi i
cavi, della distanza di
separazione raccomandata
calcolata con l’equazione
applicabile alla frequenza del
trasmettitore
Portable and mobile RF
communications equipment
should be used no closet to any
part of the MEDISOUND 3000,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
RF condotta 3 Veff_Vrms 3V
Conducted RF Distanza di separazione
raccomandata
IEC 61000-4-6 da 150 kHz a 80 Recommended separation
MHz distance
150 kHz to 80 MHz
d  1.2 P
RF irradiata 3 V/m
Radiated RF 3 V/m

d  1.2 P da 80 MHz a 800 MHz

80 MHz to 800 MHz
IEC 61000-4-3
da 80 MHz a 2,5
GHz d  2.3 P da 800 MHz a 2,5

32
Rev.2.13.A
 80MHz to 2,5 GHz GHz
800 MHz to 2,5
GHz

ove P è la potenza massima

nominale d’uscita del
trasmettitore in Watt (W)
secondo il costruttore del
trasmettitore e d è la distanza di
separazione raccomandata in
metri (m).
Where P is the maximum output
power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).

Le intensità di campo dei

trasmettitori a RF fissi, come
determinato da un’indagine
elettromagneticaa del sito
potrebbe essere minore del
livello di conformità in ciascun
intervallo di frequenzab
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site surveya,
should be less than the
compliance level in each
frequency rangeb.

Si può verificare interferenza in

prossimità di apparecchi
contrassegnati dal seguente
simbolo:
Interference may occur in the
vicinity of equipment marked
with the following symbol:

Note_s:
(1) A 80 MHz e 800 MHz; si applica l’intervallo di frequenza più alto.
At 80 MHz and 800 MHz, the higher frequency range applies.
(2) Queste linee guida potrebbero non applicarsi in tutte le situazioni. La
propagazione elettromagnetica è influenzata dall’assorbimento e dalla
33
Rev.2.13.A
 riflessione di strutture, oggetti e persone.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Le intensità di campo per trasmettitori fissi come le stazioni base per
radiotelefoni (cellulari e cordless) e radiomobili terrestri, apparecchi di
radioamatori, trasmettitori radio in AM e FM e trasmettitori TV non possono
essere previste teoricamente e con precisione. Per valutare un ambiente
elettromagnetico causato da trasmettitori RF fissi, si dovrebbe considerare
un’indagine elettromagnetica del sito. Se l’intensità di campo misurata nel
luogo in cui si usa il MEDISOUND 3000, supera il livello di conformità applicabile
di cui sopra, si dovrebbe porre sotto osservazione il funzionamento normale del
MEDISOUND 3000. Se si notano prestazioni anormali, possono essere necessarie
misure aggiuntive come un diverso orientamento o posizione del MEDISOUND
3000.
Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the MEDISOUND 3000 is used
exceeds the applicable RF compliance level above, the MEDISOUND 3000
should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or
relocating the MEDISOUND 3000.
b L’intensità di campo nell’intervallo di frequenza da 150 kHz a 80 MHz dovrebbe
essere minore di 3 V/m
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
3 V/m.

TAB. 206
DISTANZE DI SEPARAZIONE RACCOMANDATE TRA APPARECCHI DI
RADIOCOMUNICAZIONE PORTATILI E MOBILI E GLI APPARECCHI O I SITEMI PER
APPARECCHI O SISTEMI CHE NON SONO DI SOSTENTAMENTO DELLE FUNZIONI
VITALI
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT OR SYSTEM FOR EQUIPMENT
AND SYSTEM THAT ARE NOT LIFE-SUPPORTING
MEDISOUND 3000 è previsto per funzionare in un ambiente elettromagnetico in
cui sono sotto controllo i disturbi irradiati RF. Il cliente o l’operatore del
MEDISOUND 3000 possono contribuire a prevenire interferenze elettromagnetiche
assicurando una distanza minima fra gli apparecchi di comunicazione mobili e
portatili a RF (trasmettitori) e MEDISOUND 3000 come sotto raccomandato, in
relazione alla potenza di uscita massima degli apparecchi di
radiocomunicazione.
The MEDISOUND 3000 is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the
MEDISOUND 3000 can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
34
Rev.2.13.A
equipment (transmitters) and the MEDISOUND 3000 as recommended below,
according to the maximum output power of the communications equipment.
Potenza di uscita Distanza di separazione alla frequenza del trasmettitore
massima del (m)
trasmettitore Separation distance according to frequency of transmitter
specificata (m)
Rated maximum
output power of Da 150 kHz a_to Da 80 MHz a_to Da 800 MHz a_to
transmitter 80 MHz 800 MHz 2,5 GHz
W
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

Per i trasmettitori specificati per una potenza massima di uscita non riportata
sopra, la distanza di separazione raccomandata d in metri (m) può essere
calcolata usando l’equazione applicabile alla frequenza del trasmettitore, ove P è
la potenza massima d’uscita del trasmettitore in Watt (W) secondo il costruttore
del trasmettitore
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be determined using the
equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Nota_e
(1) A 80 MHz e 800 MHz, si applica l’intevallo della frequenza più alto.
At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
(2) Queste linee guida potrebbero non applicarsi in tutte le situazioni. La
propagazione elettromagnetica è influenzata dall’assorbimento e dalla riflessione
di strutture, oggetti e persone.
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.

35
Rev.2.13.A
 DOMINO s.r.l.
via Vittorio Veneto 52
31013 Codognè – TV – ITALY
Tel. (+39) 0438.7933 36
Rev.2.13.A Fax. (+39) 0438.793363
E-mail: info@globuscorporation.com
www.globuscorporation.com