Periso CTU MEGA 20 User manual

DEVICE FOR DIAMAGNETIC THERAPY

CTU MEGA 20 Diamagnetic Pump MOD07-2-5 Rev.13 of 28/08/2019
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PERISO SA

CTU MEGA 20 Diamagnetic Pump MOD07-2-5 Rev.13 of 28/08/2019
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PERISO SA
Index
1. INTRODUCTION ....................................................................................................................... 4
1.1 Introduction to the CTU Mega 20 device ................................................................................ 4
1.2 Introduction to the manual ...................................................................................................... 4
1.3 Safety precautions and warnings ......................................................................................... 5
1.4 Shipping damage ....................................................................................................................... 7
1.5 Contents of the package ........................................................................................................ 7
1.6 Warranty Conditions .................................................................................................................. 8
1.7 Area of Jurisdiction .................................................................................................................... 8
2. GLOSSARY AND WRITING CONVENTIONS ............................................................................ 8
2.1 Glossary of symbols ...................................................................................................................... 8
2.2 Writing Conventions .................................................................................................................... 10
3. INSTALLATION ........................................................................................................................ 10
3.1 Installation Instructions ............................................................................................................... 10
3.2 Operating handpiece ................................................................................................................... 14
4. OPERATING INSTRUCTIONS ................................................................................................. 15
4.1 Requiredskills ................................................................................................................................. 15
4.2 Side effects ..................................................................................................................................... 15
4.3 Operating Section ......................................................................................................................... 15
4.4 Radiofrequency for capacitive and resistive diathermy ................................................. 18
5. INDICATIONS, CONTRAINDICATIONS AND PRECAUTIONS ............................................... 20
5.1 Clinical indications ........................................................................................................................ 20
5.2 Contraindications .......................................................................................................................... 22
5.3 Precautions ..................................................................................................................................... 23
6. MAINTENANCE AND TROUBLE SHOOTING ......................................................................... 25
6.1 Cleaning and disinfection .......................................................................................................... 25
6.2 Guide to the correct maintenance .......................................................................................... 25
6.3 Troubleshooting ............................................................................................................................. 27
7. TECHNICAL SPECIFICATIONS .............................................................................................. 32
8. INFORMATION PROVIDED BY THE MANUFACTURER ........................................................ 33

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1. INTRODUCTION
1.1 Introduction to the CTU Mega 20 device
CTU Mega 20 Diamagnetic Pump is a device for physiotherapy and rehabilitation,
moreover effective in the field of orthopedics, neurology, aesthetic and sports medicine,
that allows you to perform Diamagnetic Therapy. The methodology applies the physical
principle of the magnetic repulsion, or diamagnetic effect, that concerns the behavior of
water and most of the biological substances once exposed to the effects of High Intensity
Pulsed Magnetic Fields. Also called Diamagnetic Molecular Accelerator, along with the
Magnetic Field source the system includes a particular RF generator of diathermy which
works in combination with the diamagnetic effect, to assist and improve the outcome of the
treatments.
The treatments are painless and parameterization procedures
are simple and intuitive.
The action mechanisms induced by Diamagnetic Therapy are:
 Movement of liquids
 Endogenous biostimulation
 Pain control
1.2 Introduction to the manual
This manual is an integral part of the equipment supplied with the CTU Mega 20
Diamagnetic Pump, it constitutes documentation and support for use and is not intended
for sale.
The reproduction, even partial, without the express consent of the Manufacturer is
prohibited.
It is produced by the Manufacturer’s Technical Department for exclusive use with the
Diamagnetic Pump CTU Mega 20 equipment.
We guarantee that the present manual is related to the equipment supplied. The possible
and eventual corrections or updates will be included in new editions.
All information may be subject, without notice, to change by the Manufacturer for purposes
and reasons related to technical or business improvements.
The use of the CTU Mega 20 Diamagnetic Pump implies knowledge of this manual in all
its parts. Usage not conform to the Manual automatically invalidates the warranty and
liability by the Manufacturer.

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1.3 Safety precautions and warnings
Before connecting the CTU Mega 20 Diamagnetic Pump device to the power
supply you must ensure that it has the following characteristics:
Mains voltage 230 Volt (+/- 10%)
Mains frequency 50-60 Hz
Network Consumption 2200 VA (800 W) 9,5 A
It is also necessary that the surrounding conditions are the following:
Room temperature from 10 °C to 30 °C
Relative humidity from 30% to 75% non-condensing
Atmospheric pressure from 700 to 1032 hPa
The environmental storage conditions must instead be the following:
Room temperature from 0 °C to 40 °C
Relative humidity from 10% to 80%
It should be avoided the installation of the equipment in the following cases:
Near heat sources
Exposed to rain or humidity
Exposed to direct sunlight
The Manufacturer accepts no responsibility for damage or malfunction resulting
from:
Supply mains do not conform to the above
Unsuitable environmental conditions
Do not use the device:
In the presence of combustible gases, flammable vapors, in rooms with
oxygen or detonating atmosphere
In the presence of flammable anesthetic mixture with air, oxygen or nitrous
oxide
Near equipment with strong electromagnetic emissions or sensitive to
electromagnetic emissions
Near to or over other equipment
Keep the device away from splashing water, even accidental.

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Avoid using the device in combination with monitoring devices.
Portable and mobile communications equipment can affect the operation of the
device.
In the diamagnetic pump mode the handpiece can be used between 4/5 cm
away from the skin of the patient.
ATTENTION: only distilled water should be used in the tank.
Connection to the power supply
Connecting the device to the power supply is simple and immediate, and must be made
by the use of the power cable following the instructions below (Chapter 3).
To avoid the risk of electric shock, this device must be connected only to mains
supplies with a protective ground connection
If the power cable is damaged, it must be replaced only by the manufacturer
Periso or by personnel appropriately qualified by Periso.
Any repair work on the CTU Mega 20 product must be carried out by the
manufacturer Periso or by personnel appropriately qualified by Periso.
The device is not permanently installed and uses the power plug for separation
and isolation from the mains voltage.
The distance between the device and the power cable should be almost equal to
90 cm in order to unplugging the device if needed.
Moving the device
The device is equipped with wheels to facilitate moving in various environments. While
moving the device, it is advisable to hold the device to the outer metal frame making sure
that the wheel brakes are unlocked, as shown in figure.
Check that the wheels are unlocked before moving the device.
Check that the wheel brakes are locked every time you start a treatment.
Make sure before starting a treatment that the device is blocked on a flat floor.
It is forbidden to push the device on its side since it can cause it to tip over.

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It is recommended to use gloves to handle the handles of the power module as they
may be slightly sharpened.
1.4 Shipping damage
The equipment and all its components and accessories are subjected to careful and
accurate testing by our quality control department, which certifies the integrity and proper
functioning. Any damage and/or the failure or malfunction, must be promptly reported to
the Manufacturer, especially if entirely attributable to the negligence of the carrier. The
original packaging must be stored in order to send the device back it to the Manufacturer,
for whatever reason.
1.5 Contents of the package
CTU Mega 20 device will be shipped carefully packed in a casing that also contains all the
accessories and the manual, provided with the basic equipment. Below is a list of items
included in the casing of delivery.
Quantity
Description
1
User and Maintenance Manual
1
Service and Warranty Booklet
1
Declaration of Conformity CE
1
Method of Working
1
Power module
1
Control module
1
Trolley
1
RS232 cable
1
Operating handpiece
2
Return Plates
1
Kit coated electrodes 3 pcs. (50 mm – 75 mm – 80 mm)
1
Kit uncoated electrodes 3 pcs. (50 mm – 75 mm – 80 mm)
1
Conic shaped electrode
1
Shelf
1
Arm with electric piston
1
Plastic water bottle for tank refilling
1
Fork spanner
1
Hexagonal key 3 mm
1
Hexagonal key 5 mm
2
Ignition keys
1
Handpiece spring
1
Diamagnetic Complex Cream

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1.6 Warranty Conditions
Refer to the Service and Warranty Booklet provided in the shipping wrap. Service life
expected for CTU Mega 20 device is 10 years.
1.7 Area of Jurisdiction
For any dispute regarding these conditions the exclusive jurisdiction is the one in Lugano
(CH), in Italian Language.
2. GLOSSARY AND WRITING CONVENTIONS
2.1 Glossary of symbols
Press “Enter” to move to the next screen after
the initial one.
Press “Start” to start.
o
Press “Exit” to exit the current screen and to
return to the previous one.
o
Increase or decrease of the relative activity.
Increase or decrease the activity time.
Press “Start” to start the treatment.
Press “Stop” to interrupt the treatment.
o
Press “Sel” to select a determined option
or program.
Press “Reset” to return to initial settings.
Only one plate in use.
Two plates in use.
Caution: high value.

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Service messages that appear at the top of the
screen.
Label symbols
CE mark.
Temperature Limitation.
Indicates the Name
and Address of the
Manufacturer.
Humidity Limitation.
Consult the Instruction
Manual.
Atmospheric pressure
limitation.
Applied Component
type BF.
Keep away from sunlight.
Non Ionizing
Emissions.
Keep dry.
Obligatory to read the
Instruction Manual.
Forbidden to Push the
Device on its side.
Serial Number.
Batch code.
ESD sensitive.
Waste Electrical and Electronic
Equipment
SN

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2.2 Writing Conventions
Highlighted
Highlights certain parts of the document, where
important and particular attention is necessary.
Note
Notes that put in highlight important instructions for
specific uses.
Caution
These messages appear before the description of
operations which, if not observed, may cause damage to
the equipment or its accessories, and to people.
Forbidden
This message is placed before operations that must
never be carried out.
3. INSTALLATION
3.1 Installation Instructions
The CTU Mega 20 device must be extracted from the front of the box after removing the
safety locks. Then remove all accessories and check its integrity.
The device comes partially assembled, the only operations to be performed are:
 Mount the arm
 Assemble the electrodes shelf
 Connect the cables
Attach the arm with the supplied screws: two
to attach it to the trolley (a) and one to
secure it to the electric motor (b).
a
b

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Assemble and secure the shelf with
appropriate and supplied screws.
Fix the control module on the trolley with
four supplied screws.
Button to move up the arm.
Button to move down the arm.

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1) Connect the female DB9 pin connector to its male connector on the back of the
power module.
2) Connect the plug of the control module to the socket.
3) Connect the motor plug of the arm to the connector.
4) Connect the plugs of the neutral plates to connectors.
5) Connect the handpiece connector to its socket.
CAUTION: Connect the handpiece to the connector of the power module always
when the device is disconnected to the power supply.
6) Connect the female DB9 pin
connector to its male
connector on the back of the
control module.
1
2
3
4
5

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7) Plug the connectors of the
water pipes of the handpiece
to the respective sockets,
applying slight pressure.
Removable cap for topping up
with dematerialized water.
8) Connect the device to the
power network.
It is always advisable not to use extension cords and/or multiple sockets between the
wall outlet and power card, since possible malfunctions and system damage could
result from this type of connection. If however, it becomes necessary to use this type
of connection, make sure that those components are fully functional and equipped
with a grounding conductor.
The device must be positioned in such a way that it is feasible to operate on the plug
or on the switch if it is necessary to interrupt the connection with the mains.
Turning ON and OFF the device
To turn on the device, turn the key on the front of the power module clockwise; to turn it the
device, turn the key counterclockwise.
Emergency Button
If it is necessary to IMMEDIATELY block the device push the
red button shown in the figure.
To unlock the device, rotate the button in the direction of the
arrow.

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No modification of this equipment is allowed.
Never turn off the device by unplugging the power cable in order to avoid software
damage or anomalies.
The machine stops when a red light in the back switch on the back of the module; it
indicates a low level of cooling water, meaning that the head of the handpiece is
not cooled adequately. In this case, top up the cooling water with the supplied bottle.
If the problem persists, contact PERISO Technical Support:
Email: assistanceme[email protected]
Telephone: [phone]
3.2 Operating handpiece
The CTU Mega 20 Diamagnetic Pump device is equipped with a moveable operating
handpiece. Inside the handpiece there is a coil for the generation of the magnetic field.
This coil is equipped with a liquid cooling system.
The mobile hand piece must be connected to the device by means of the relative 3
connectors. In particular, it should be performed in the following sequence:
1) Connect the two cooling tubes, paying particular attention to the direction of insertion;
2) Connect the power cord.
The handpiece must never fall on the ground. It should be always clean, after each
treatment exclusively with mild liquid detergent.
Do not leave the handpiece for too long on the same area of the body being treated,
as it may cause burns.
Periso SA recommends to carry out treatments lasting 20/30 minutes and leave the
CTU MEGA 20 device on standby without performing any treatment for at least 10
minutes, to avoid overheating of the handpiece.
Replacing of the operating handpiece
The replacement of the operating handpiece is easy to perform and should be done by
following the procedure below:
1) Disconnect the power supply first;
2) Disconnect the hydraulic joints, pressing lightly on the sealing ring (the sealing rings
are self-locking to prevent accidental refrigerant leakage);
3) Slide the cables out of the mechanical arm guide;
4) Detach the cables from the retaining clips in the mechanical arm;
5) For the installation of the new hand piece repeat the operations in reverse.

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4. OPERATING INSTRUCTIONS
4.1 Required skills
The CTU Mega 20 Diamagnetic Pump is a device intended to be used by medical staff
and/or physiotherapist. It can be used in:
Physiotherapy Clinics and Centers
Hospital Rehabilitation Clinic
Aesthetic Medicine
4.2 Side effects
The CTU Mega 20 Diamagnetic Pump equipment does not cause any kind of intolerance
or unpleasant events following the treatment sessions. Problems may arise as the result
of a combination of factors involving the inappropriate use of the device in extent and in
modality of treatment. The use of the device is operator-dependent (doctor or
physiotherapist and in any case qualified). Treatments contrary to the characteristics of
the pathology and of the subject being treated may, theoretically, cause cell damage as
well as non-thermal effects of unknown nature.
The manufacturing company is not liable for the misuse of medicines, over/under
doses or of inappropriate designation to the pathology being treated.
4.3 Operating Section
Turn on the device using the power key located on the front of the power module and
unlock the emergency button. When the device is on, the following screen will appear:
Press the button to move to the next screen.
The system will then go to the selection of the operating mode screen, allowing you to

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select from three possible applications:
 Movement of liquids;
 Endogenous biostimulation;
 Pain Control.
Select one of the operating modes among those displayed.
Depending on the operating mode required, select the working parameters related to the
section Magnetic Field and relative to the section Radio Frequencies.
Press the button to return to the home screen.
Movement of Liquids
Action on intracellular and extracellular fluid
In treatments aimed at movement of liquids, it is possible to
select the greater or lesser activity on intracellular liquid than
those extra- cellular, or vice versa, by selecting the percentage
of activity.
The movement of liquids mode is used every time you need
drainage of the extracellular matrix or metabolic stimulation of
the cells. This mode can be performed alone or alternating the
endogenous stimulation.
The intracellular liquid movement mechanism supports the reconstitution and the
regeneration of damaged tissues. Acting on the keys, you can select a higher or lower
activity/application on intracellular liquid in respect to the extracellular:

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Endogenous Biostimulation
Biostimulation
It corresponds to the amplitude of electrical stimulation induced
within the tissues.
You can operate selectively, for each specific tissue, choosing the
parameter corresponding to the activity that is intended to get on at
cellular and sub-cellular level.
With this mode you can create a particular tissue biostimulation:
endogenous type, developed directly within the tissue;
isotropic type, that is homogeneous throughout the tissue invested by the magnetic
field;
cell type, allowing you to restore the metabolic activities of the cells.
For this operating mode you can select two parameters:
Stimulation Power
This parameter corresponds to the magnetic field gradient used and allows you to
select a greater or lesser intensity of tissue stimulation.
Treatment Target
Thanks to variations of the intrinsic frequency rate managed by the machine, it is
possible to select the tissue to be stimulated touching the corresponding icon.

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Pain Control
In this operating mode you can treat acute or chronic pain.
The parameters on which to interact are Joule and Hz.
The Hz represent the repetition frequency of the pulses generated by the magnetic field.
By pressing the buttons with the arrow keys you can increase or decrease the frequency.
It ranges from a minimum of 1 Hz to a maximum of 7 Hz.
The Joule represents the strength of the magnetic field generated. By pressing the buttons
with the arrow keys you can increase or decrease the power. The possibilities are: 10J,
30J, 50 J, 70 J, and 90 J.
4.4 Radiofrequency for capacitive and resistive diathermy
Parameterization of capacitive and resistive diathermy
Radiofrequencies have as primary therapeutic purpose the analgesic effect and the
oxygenation of the tissues due to vascular effects. The capacitive energy transfer allows
greater activity on soft tissues (muscle, skin, etc.) while the resistive energy transfer
allows an increased activity on the hard tissues (bones, tendons, etc.).
You can select the following activities:
Frequency
You can select the emission frequency, High Frequency (HF) or Low Frequency
(LF), for the depth of action on tissues. In particular, HF allows more surface
activity; LF promotes deeper action in the tissues.

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Neutral plates
Depending on the area of the body to be treated, you can select "single plate" or
"double plate".
Radiofrequency power
The power adjustment from 0% to 100%, favors biostimulation processes and re-
energizing of tissues.
The procedure for the correct adjustment of the power is as follows:
1) Select the area of the body being treated. Prepare the patient in the most
appropriate position.
2) Place the neutral plate in position perpendicular to the CTU Mega 20
handpiece. Apply on neutral plate the right amount of the specific cream, such
as to entirely cover the surface of the plate.
3) Choose the capacitive or resistive electrode to be mounted at the tip to the CTU
Mega 20 handpiece, depending on the region and the pathology to be treated.
4) Select the emission frequency HF (High Frequency) or LF (Low Frequency).
5) Spread on the area to be treated an adequate amount of proper cream, to
facilitate the sliding of the CTU Mega 20 handpiece during treatment.
6) Place the CTU Mega 20 handpiece on the treatment area and slowly raise the
power by using the gray power meter on the front of the display.
It is important to remember that with the CTU Mega 20 there is the automatic recognition
of the capacitive and/or resistive electrode, so it must not be preselected on the display.

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Reading and recording of skin impedance system
This particular feature allows you to track the changes in skin impedance, with respect to
energy delivered, allowing you to monitor the progress of treatment sessions.
5. INDICATIONS, CONTRAINDICATIONS AND
PRECAUTIONS
5.1 Clinical indications
The use of CTU Mega 20 is indicated for the following scopes:
- Acceleration of the healing process (formation of the bone callus) in the treatment of the fractures
of the long bones (fracture gap < 1 cm).
- Reduction of pain and inflammation in musculoskeletal disorders (e.g. pubalgia, tendinitis,
sprains, contractures and muscle hematomas )
-Liquids drainage in post -traumatic edema and in lymphedema.
Below, are reported some examples of suggested treatments (these are only suggested
treatments, the choice of the treatment protocol is solely responsibility of the
medical/paramedical personnel in charge):
• Reduction of pain and localized inflammation - Knee Osteoarthritis
PROTOCOL
Magnetic Field=2 Tesla; Intensity=90 J; frequency of impulses=7Hz;
duration=30minutes/session and 1 session/day for a maximum period of 3 weeks.
EXCLUSION CRITERIA
Before performing the treatments with PEMF CTU Medical Device – PERISO SA, all the
patients received a clinical evaluation to exclude patients with: open physis,
inflammatory joint disease. Acromegaly, Charcot’s arthropathy, Haemochromatosis,
Wilson’s disease, Ochronosis, terminal illnesses/malignancies, pregnancy or lack of
contraception use in women of childbearing age, use of pacemaker or any electrical
device and ferromagnetic implants in the area of treatment
• Reduction of pain and localized inflammation - Chronic Low Back pain
PROTOCOL
Magnetic Field=2 Tesla; Intensity=90 J; frequency of impulses=7Hz;
duration=30minutes/session and 3 session/week for a maximum period of 3 weeks.