Globus MEDISOUND 3000 User manual

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DEAR CUSTOMER
THANK YOU FOR CHOOSING A GLOBUS PRODUCT. WE REMAIN AT YOUR ENTIRE DISPOSAL
FOR ANY ASSISTENCE OR ADVICE YOU MAY NEED
DOMINO s.r.l.
via Vittorio Veneto 52
31013 - Codognè - TV - Italy
Tel. [phone]
Fax. [phone]
e-mail: [email protected]
www.globuscorporation.com

Table of contents
TECHNICAL FEATURES.......................................................................................................................................................5
Device............................................................................................................................................................................5
Transducer ....................................................................................................................................................................5
Power supply.................................................................................................................................................................5
Battery (optional)..........................................................................................................................................................5
Use and storage conditions...........................................................................................................................................5
INTENDED USE OF THE DEVICE.........................................................................................................................................6
DEVICE CLASSIFICATION....................................................................................................................................................6
SAFETY PRECAUTIONS.......................................................................................................................................................6
Warnings before the use...............................................................................................................................................7
Warnings during the use...............................................................................................................................................7
Side effects....................................................................................................................................................................7
Contraindications..........................................................................................................................................................8
EQUIPMENT ......................................................................................................................................................................8
DEVICE OPERATION...........................................................................................................................................................8
Device............................................................................................................................................................................9
Handpiece .....................................................................................................................................................................9
Accessories (rechargeable battery) ..............................................................................................................................9
DEVICE DESCRIPTION......................................................................................................................................................10
Keyboard.....................................................................................................................................................................10
DEVICE USE......................................................................................................................................................................11
Choosing and starting an existing program ................................................................................................................11
Creating a new program .............................................................................................................................................12
Settings........................................................................................................................................................................12
PROGRAM LIST................................................................................................................................................................14
MAINTENANCE AND CLEANING......................................................................................................................................16
Maintenance and cleaning of the device....................................................................................................................16
Usable life of the device..............................................................................................................................................16
Disposal of the device.................................................................................................................................................16
APPLICATION METHOD...................................................................................................................................................17
Direct contact method................................................................................................................................................18
Immersion method .....................................................................................................................................................18
SYMBOLS AND LABELING................................................................................................................................................19
SOUND AND LIGHT SIGNALS AND ALARMS ....................................................................................................................21
WARRANTY CONDITIONS................................................................................................................................................22
EMC accompanying documents......................................................................................................................................23

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TECHNICAL FEATURES
Device
Case: ABS food grade
Protection level of the case: IP 20
Dimensions: 170x220x60
Weight: about 1000 g.
Certifications CE MDD certificate
Transducer
Transducer: Head Ø 4.2 cm.
Transducer emission: continuous, pulsed.
Emission frequency: 1- 3 MHz
Duty Cycle: 10%-100%
Maximum power: 3 W/cm² (± 20%)
Protection level of the handpiece: IP 67
Power supply
XP Power
Type AC/DC
Model: AFM60US18C2
PRI: 100-240Vac 1.5A 50-60Hz
SEC: 18Vdc 3.34A
Battery (optional)
Battery pack: Ni-MH 12V 4Ah
Use and storage conditions
Temperature: from 0°C to 35°C
Max. relative humidity: from 15% to 93%
Atmospheric pressure: from 700 hPa to 1060 hPa
Storage and transportation temperature: from -10°C to 45°C
Max. relative humidity: from 30% to 75%

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INTENDED USE OF THE DEVICE
Medisound 3000 is not intended for domestic use, and it has been conceived to be used in the
following operating environments:
- clinics;
- physiotherapy centers;
- rehabilitation in general;
- general pain treatments (medical sector).
The use of the device is permitted only to qualified personnel (doctors and physiotherapists).
DEVICE CLASSIFICATION
The device has been manufactured in compliance with applicable technical standards, and it has
been certified in compliance with Directive 93/42/EEC as amended by directive 2007/47/CE on
medical devices, by the Notified Body Kiwa Cermet Italia, Via Cadriano 23, 40057 Granarolo
Dell’Emilia (BO) Italy (n° 0476), in order to ensure product safety.
Medisound 3000 is classified as:
- Class IIa device (Directive 93/42/EEC, Annex IX, rule 9, as amended).
- Class II with BF type applied part (Classif. CEI EN 60601-1);
- device with casing not protected against the penetration of water;
- device and accessories not subject to sterilization;
- device not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or
nitrous oxide;
- device for continuous operation;
- device not suitable for outdoor use.
SAFETY PRECAUTIONS
To ensure maximum safety, the device must be used respecting the rules and the limitations
indicated by the user manual.
The manufacturer declines all responsibility for all use differing from what is indicated in this manual.
The full or partial reproduction in any form and by any electronic or mechanical means of the texts
and/or pictures contained in this manual without the written authorization of the manufacturer is
forbidden.
If the package, the cable or the connector of the power supply show signs of wear or damage,
replace it instantly.
The device should be connected to the mains with its power supply; before doing so, make sure that
the power system complies with the directives in force in your country. Make sure that the power
supply will be easily unplugged.
It is strictly forbidden to modify the device.

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Warnings before the use
We advise against the use of the device in conjunction with other electronic devices, especially with
those used to maintain vital functions, make reference to the tables attached, for a correct use of
the electromedical device. If you have to use the device near or upon other devices, pay attention
to how it is working.
Read carefully the entire operating manual before using the device; keep this manual with care.
The unit must be used only with the diffusers provided with the original equipment (or Globus brand)
and according to the therapeutic methods described.
Before every use, always check the integrity of the device. This is a fundamental requirement for
carrying out the therapy; do not use the device if the buttons or the cables are defective or
malfunctioning.
The device:
- as you turn the device on, make sure that the software version and the model of the device appear
on the screen, which means that the device is working and ready to be used.
If it does not show that information or it does not show all the segments, turn it off and on again. If
the problem persists, contact the service center and do not use the device.
- Shutdown right after turning on indicates that the battery is low. Recharge as indicated in the
section HOW TO CHARGE THE BATTERIES (if Medisound 3000 works with the rechargeable battery
pack purchased as an optional accessory).
Warnings during the use
Medisound 3000 has been designed for a continuous use.
If the cables are damaged, replace them with original spare parts and do not use them anymore.
The device must be kept out of the reach of pets that may damage it and contaminate it with
parasites.
The cable of the diffuser and of the power supply must never be wound up around the neck to avoid
all risk of strangulation and suffocation.
Mobile and fixed radio communication devices might affect the operation of the electromedical
device: see the tables attached to this manual.
Side effects
With high power intensity, the ultrasound head in contact with the skin may reach temperatures
above 41°C, which may redden or cause light burns to the skin. In these cases it is advisable to
replace the gel often or do the therapy in immersion. If, at the end of the treatment, skin redness or
light burns are observed, it is advisable to refresh the part with cold running water. If the problem
persists, it is possible to treat the part with a medication by using medicated gauzes (with
connectivine, fitostimoline), which accelerate the skin regeneration process, or use specific creams,
available on the market, containing the same substances.
Isolated cases of skin irritation may occur in subjects with high skin sensitivity.
In case of allergic reaction to the gel, suspend the treatment and contact a specialist.

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Contraindications
Do not use ultrasounds in the following cases:
- patients with cancer diseases, because ultrasound can favor the proliferation of tumor cells;
- on hematomas;
- conditions such as thrombophlebitis, in which the administration of ultrasounds can cause the
rupture of emboli;
- areas affected by acute sepsis, because the infection can spread;
- radiotherapy produces the opposite effect on tissues, so ultrasound should not be used on areas
exposed to radiations for at least six months after the last irradiation;
- osteoporosis, because ultrasound can promote decalcification. This is not an absolute
contraindication, consult your physician;
- articulations with epiphysis during the bone growth phase.
- on the ocular area and near it;
- during pregnancy and menstrual periods in the abdominal and lumbar areas;
- near glands and the heart.
EQUIPMENT
-Carrying case
-Ultrasound gel (REF G0869)
-Power supply (REF 5216)
-Device
-Transducer (G5374)
The device comes fully equipped with ultrasound gel, transducer, 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 combined with some optional accessories (see the features on our website
www.globuscorporation.com). To purchase these accessories, please contact your dealer.
Accessories not included:
- Ref. G1120 rechargeable battery (Ni-MH 12 V 4Ah)
- Ref. G5516 Handpiece 16 mm for Medisound 3000
DEVICE OPERATION
In order to start the device, the following elements must be connected. Pay particular attention to
avoid damage to the connections.

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Device
Power supply by electricity mains. Medisound 3000 works connected to the mains (the rechargeable
battery is not supplied with the device but can be requested as an optional accessory). To connect
the power supply to the connector, plug it as shown in the figure (see arrow below).
Handpiece
To connect the handpiece to the device, plug the connector in the intended inlet on the back of the
unit (see picture). The part of the connector with the word Globus must be kept upwards.
Accessories (rechargeable battery)
The device can be powered with a set of rechargeable nickel-metal hydride batteries (12Vdc
4000mAh) with high performances and without memory effect (the rechargeable batteries are
optional).
It is advisable to recharge the batteries when the battery indicator on the display indicates ¼. Turn
the device off and disconnect the diffuser, then connect it to the included power supply by inserting
the plug in the appropriate inlet.
Do not use a power supply different from the one provided with the device. Contact the customer
service to replace the battery pack.

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Name of the program
030 18
Duty % min
0.20W/cm² 1 MHz
DEVICE DESCRIPTION
The execution screen on the device display will be explained below.
1 - Indicates the name of the selected program
2 - Indicates the duty cycle used in the selected program
3 - Power in Watts per cm²
4 - Indicates the type of power supply used
5 - Indicates the status of the handpiece (in operation, paused, disconnected ...)
6 - Treatment duration
7 - Emission frequency
Keyboard
1- UP/DOWN buttons: to increase and decrease the power.
2- Fn button: changes the power display indicating the total power and not the power per cm²
3- ON/OFF/OK button: turn on, turn off, confirm treatment
4- * Time button: modification of the treatment duration
5- Left/Right button: to navigate/return to the main menu
6- P+/P- button: to select the menu, the area and the program
1
2
3
4
6
5
8
7
1
2
3
4
5
6
7

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DEVICE USE
Automatic calibration of the handpieces
Each time the machine is switched on, it automatically carries out the head calibration procedure.
Note: at start-up, the head must be clean, dry and free in the air (not in contact with any object or
surface).
Turning the device 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.
Choosing and starting an existing program
Follow the flow chart:

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Creating a new program
Follow the flow chart:
The saved programs will be stored in My Programs.
Press fn to delete a saved program.
Settings
By selecting Settings you access the menus to adjust the following functions:
• Acoustic signals
• Auto shut-off timer
• Contrast
• Language
Follow the flow chart:

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Acoustic signals
If the acoustic signal function is on (ON) the device emits a tone when buttons are pressed.

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Automatic shutdown
It allows to set the time after which, if not used, the machine switches off. It is possible to select a
value between 1 and 20 minutes.
Use P+ and P- to select and confirm with the Ok button.
Contrast
Use the arrows to improve the contrast of the display and better read the information displayed.
Language
It is possible to select the interface language.
System information
It shows information about the hardware and software configuration of the device as well as the
total time of use of the device.
PROGRAM LIST
List of the Medical programs contained in the HEALTH –REHAB area
Name of the program
Recommended
power
Hip osteoarthritis
1 W/cm²
Knee osteoarthritis
1 W/cm²
Shoulder osteoarthritis
0.8 W/cm²
Spinal osteoarthritis
1 W/cm²
Ankle osteoarthritis
1 W/cm²
Osteoarthritis
1 W/cm²
Pseudoarthritis
1 W/cm²
Wrist Fracture
0.3 W/cm²
Fatigue Fracture of Tibia
0.2 W/cm²
Fracture
0.3 W/cm²
Carpal Tunnel
1 W/cm²
Epicondilytis
1.5 W/cm²
Back pain
1.2 W/cm²
Calcified shoulder tendinitis
1.5 W/cm²
Muscle Pain
0.5 W/cm²
Cervical Pain
1.5 W/cm²
Trapezius pain
1.2 W/cm²
Spinal stenosis
1.5 W/cm²
Because of the presence of clinical programs, this product is a medical device. Therefore, it is certified by the Kiwa Cermet
Italia Body n. 0476 according to the 93/42/EEC EU directive for medical devices. The certification covers clinical applications.

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List of Aesthetic programs (non-medical treatments)
Name of the program
Recommended
power
Edematous cellulite
1 - 2 Watt/cm2
Fibrous cellulite
1 - 2 Watt/cm2
Lipolysis
1 - 2 Watt/cm2
Hypotonie
1 - 2 Watt/cm2
Stretch marks
1 - 2 Watt/cm2
Orange peel skin
1 - 2 Watt /cm2
Skin smoothing
1 - 2 Watt/cm2
Arms lymphatic drainage
1 - 1.5 Watt/cm2
Massage
1 - 1.5 Watt/cm2
Skin restructure
0.5 - 1 Watt/cm2
Face lifting
0.5 - 1 Watt/cm2
Photoaging treatment
0.5 - 1 Watt/cm2
Abdomen relaxation
1 - 2 Watt/cm2
Abdomen adiposity
1 - 2 Watt/cm2
Flabby thighs
1 - 2 Watt/cm2
Thigh/hip drainage
1 - 2 Watt/cm2
Thigh/hip massage
1 - 2 Watt/cm2
Gluteus/hips adiposity
1 - 2 Watt/cm2
Relaxation
0.5 - 1 Watt/cm2
Arm lymphatic drainage
0.5 - 1 Watt/cm2
Breast stretch marks
0.5 - 1 Watt/cm2
Breast relaxation
0.5 - 1 Watt/cm2
Wrinkle treatment
0.5 - 1 Watt/cm2
Scar treatment
0.5 - 1 Watt/cm2
Rosacea
0.5 - 1 Watt/cm2
Telangiectasias
0.5 - 1 Watt/cm2
Body pimples
0.5 - 1 Watt/cm2
Face pimples
0.5 - 1 Watt/cm2
Face acne
0.5 - 1 Watt/cm2
Keloid treatment
0.5 - 1 Watt/cm2
Active principle application
0.5 - 1 Watt/cm2
CE0476 does not refer to non-medical treatments.

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MAINTENANCE AND CLEANING
Maintenance and cleaning of the device
In case of actual or alleged malfunctioning, do not tamper with the device do not try to repair it by
yourself.
Do not try to repair the device and do not open it. Only specialized and authorized centers can repair
it.
Avoid violent impacts, which may damage the device and lead to malfunctioning even if not
immediately detectable.
Use this device in a dry, open-space environment (not wrapped in any materials).
Clean the device and the accessories only with disinfectant with sodium hypochlorite or quaternary
ammonium salt (percentage: 0.2-0.3%) diluted with distilled water. After cleaning/disinfecting the
device and its accessories, dry them perfectly with a clean cloth.
Always use the device and the accessories with clean hands.
It is recommended to use the device and the accessories in a clean environment to avoid
contamination with dust and dirt.
It is recommended to use the device in a ventilated, well-aired space.
The parts should be cleaned/disinfected after every use, unless otherwise indicated.
After cleaning and/or disinfecting the head of the device and after each treatment, ensure that the
head has no cracks or fissures whereby the conductive liquid may leak.
If the treatment head has cracks or fissures, replace it immediately.
Handle the treatment head with care. Inaccurate handling can modify its features.
The maintenance of the device should be made every 24 months. Contact the manufacturer for
information about the maintenance process.
Usable life of the device
The product has an estimated usable life of 5 years. It is advisable to return the device to the
producer or an authorized center to perform security and maintenance checks every two years.
The device can be used continuously when connected to the mains. The numbers of treatments
depends on the battery charge. The estimated duration of the battery is of 6 months. Thereafter, it
is advisable to replace it.
Disposal of the device
Do not throw the device or parts of it into the fire; dispose of the product in the specialized centers
and respecting the regulations 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 device.
Correct waste separation or following the above-mentioned procedure contribute to avoiding
possible negative effects on environment and health and promote the reuse and/or recycle of the
materials that compose the device. The illegal disposal of the product entails the application of
administrative fines in accordance with applicable regulations.

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APPLICATION METHOD
Specific health applications
The therapeutic effects of ultrasound are partly due to the increase in temperature. They include
analgesia, the fibrolytic effect and the 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 disruption of the collagen
fibers of the fibrous tissues.
c) Trophic effect
Vasodilation, induced by temperature increase, facilitates the removal of catabolites and supplies
the tissues with nutritive substances and oxygen; thus, ultrasounds improve the tissue trophism,
facilitate the repair of the damaged tissues and accelerate the resolution of the inflammatory
processes.
FITNESS and BEAUTY specific applications
- Applications for the absorption of active substances on the face and the body. The program is
used for the application of cosmetic agents.
Ultrasound facilitates the absorption of oils, fat-soluble vitamins, products with liposome, emulsions
and water-soluble agents.
The effect is to increase the permeability of the cells, decrease the skin functional barrier and
increase the active ingredient channel activity.
- Treatment for surface wrinkles and sensitive skins.
The treatment is used to flatten-smooth wrinkles (expression wrinkles). Ultrasound, thanks to its
thermal effects, warms the tissues and promotes the biochemical and metabolic processes.
- Treatment for acne, pimples on face and body.
In addition to an anti-inflammatory effect, the ultrasound activates the fibroblasts, which have an
important role in the process of post-inflammatory regeneration. The collagen and elastic fibers
produced after the ultrasound treatment, increase tissue elasticity, reducing the possible formation
of post-acne scars. It is also possible to facilitate the absorption of anti-acne products and increase
their effectiveness.
- Anti-cellulite treatments.
Ideal for cellulite problems. The thermal effect entails the mobilization of fat on the treated area.
This way, fat metabolism and removal are enhanced.
Ultrasound action mechanism
Mechanical effects: the mechanical action is induced by the particle movement in the tissues
crossed by the ultrasonic wave.
Although the movement of the single particles is small, the pressure variations that it produces are

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considerable and generate important mechanical effects inside the tissues.
The mechanical modifications induced by ultrasounds 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 ultrasounds through "the soft" tissues creates an increase in
temperature with:
- the absorption linked to viscosity,
- the absorption induced by thermal conductivity and chemical absorption.
Ultrasounds produce 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 increase
generates, as secondary effects, an increase in the cellular metabolism and the vasodilatation.
Chemical effects: the chemical action, with the modification of the local ph and of the permeability
of cellular membranes and with molecular changes, is caused by the remarkable accelerating forces
to which tissue particles are subjected at the passage of the ultrasonic wave.
The therapy with ultrasound can be carried out in two different modes: direct contact, with mobile
head, and immersion.
Direct contact method
The direct contact mode consists in putting the emitting head in direct contact with the skin and
interposing a substance (usually a special conductive gel) which favors the transmission between the
head and the skin, the adherence and sliding and the elimination of possible air between the skin
and the transducer, as the air, due to its reflecting capacity, would hinder the transmission of the
ultrasonic wave.
Immersion method
It is useful when the surfaces to be treated are too small or irregular or when the area is so painful
as to prevent direct contact. The part to be treated is immersed in a container with water together
with the emitting head, placed at a maximum distance of 2-3 cm from the body surface to avoid an
excessive dispersion of the ultrasonic beam with a decrease in therapeutic efficacy.
The water temperature has to be about 37°. The lower the water temperature, the greater the
cutaneous heat loss and the lower the therapeutic effect.
The head can be moved in concentric circles holding the head surface parallel to the skin surface to
reduce the refraction as much as possible. 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, reflecting 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 clean up the emission area of
the head at the end of the treatment.

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In a treatment with non-degassed water, the lowering of the ultrasound power is greater than in the
direct contact treatment, so a higher dosage is required. When you use gas-free water, instead, the
dosage has to be the same as in the contact treatment.
Recommended intensity
The device starts from a preset intensity of 0.0 Watt/cm2 and can reach a maximum power that
depends on each protocol. The intensity shown in this manual is the one we suggest for this product
line and is used in most of the known protocols. The physiotherapist is free to use the maximum
recommended power or to adjust it according to the type of patient to treat.
SYMBOLS AND LABELING
Annex 1: symbols and labeling on the device
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 class II device.
It indicates that this device has BF-type applied parts.
WEEE symbol (Waste of Electrical and Electronic Equipment). Recycling symbol.
The WEEE symbol used for this product indicates that the product cannot be treated as a
household waste. The proper disposal of the product will contribute to protecting the
environment. For further information on the recycling of this product, please contact the
concerned office of your local body, the household waste management company or the
store where the product was purchased.
It indicates that the product has been produced in compliance with the directive
2011/65/EEC.
It indicates the recommended temperature for the storage and transportation of the
product.
It informs the operator that s/he must read the manual before using the device.
It informs the operator about a general compulsory behavior.
It indicates the manufacturer.
Alarms disabled.

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It indicates the serial number of the device.
Ionizing emissions
It informs that the outputs of the device are sensitive to electrostatic discharges
IP
It indicates the protection against the ingress of water and dust.
PRI
Mains voltage
SEC
Power supply voltage
It indicates the pressure of the environment in which the device and the accessories are
transported and stored.
It indicates the humidity of the environment where the device and its accessories are
stored and transported
AER
Effective radiating area
RBN
Beam nonuniformity ratio
Device
The first 4 digits of the serial number indicate the week and year of manufacture of the device
you purchased (for example, if the code is *** 2319 *****, it means that the device was
manufactured in week 23 of 2019).
Ultrasound head
Input PWR: XP Power Model: AFM60US18C2
PRI: 100-240 V~ 1.5 A 50-60 Hz
SEC: 18 Vd.c. 3.34 A
Input power: 18 Vd.c.
Acoustic Working Frequency: 1 MHz - 3 MHz
Output: 3 ± 20% W/cm2Pulse Duration: 100ms–900ms
Waveform: Continued –Pulsed Duty factor: 10% to 100%
Ultrasound: MEDISOUND 3000
SN: MS3191701234
Internal Battery: 12 V NiMH 4000 mAh