Globus MEDISOUND 1000 User manual

ULTRASOUND THERAPY
MEDISOUND 1000
MEDISOUND 3000
User Manual
ULTRASOUND THERAPY

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Rev.2.13.A

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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. [phone]
Fax. [phone]
E-Mail: [e-mail]
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

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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. [phone]
Fax. [phone]
E-Mail: [e-mail]
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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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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Rev.2.13.A
EQUIPMENT
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.
A
B
C
D
E

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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
Output:
- it indicates the power supply outbound voltage
- it indicates the maximum power value of the magnetic field
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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Rev.2.13.A
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