Periso CTU MEGA 20 User Manual Download Page 3

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

PERISO SA

Index

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

Summary of Contents for CTU MEGA 20

Page 1: ...DEVICE FOR DIAMAGNETIC THERAPY ...

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

Page 3: ...iting 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 TROU...

Page 4: ...procedures are simple and intuitive The action mechanisms induced by Diamagnetic Therapy are x Movement of liquids x Endogenous biostimulation x 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...

Page 5: ...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 directsunlight The Manufacturer accepts no responsibility for damage or malfunction resulting from Supply mains do not conform to the above Unsuitable environmental conditions Do not...

Page 6: ...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 t...

Page 7: ... 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 ...

Page 8: ...n 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 Pres...

Page 9: ...ates 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 ...

Page 10: ...e 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 ...

Page 11: ... MOD07 2 5 Rev 13 of 28 08 2019 11 PERISO SA 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 ...

Page 12: ...ule 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 ...

Page 13: ...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...

Page 14: ...should be performed inthe 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 Peris...

Page 15: ...ice 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 dose...

Page 16: ...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 alter...

Page 17: ... 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 o...

Page 18: ... 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...

Page 19: ...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...

Page 20: ...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...

Page 21: ...s of the long bone PROTOCOL Magnetic Field 2 Tesla Intensity 90 J frequency of impulses 7Hz duration 30minutes session and 1 session day for a maximum period of 4 6 weeks EXCLUSION CRITERIA Implant loosening or failure infection nonunion healing failure after more than 9 months or without any clinical or radiographic sign of progression to union within the last 3 months a fracture gap greater than...

Page 22: ...of contraception use in women of childbearing age and use of pacemaker or any implanted electrical device were excluded and ferromagnetic implants 5 2 Contraindications IMPORTANT Before performing one or more treatments with the CTU Mega 20 Diamagnetic Pump device you must submit the patient to a medical screening in order to detect x Unsuitable physiological states x Presence of ferromagnetic mat...

Page 23: ... use please check the integrity of the connection cables and associated connectors and all moving or fixed parts to assure good working order In case of damage or deterioration of the cables or power supply contact support The use of accessories transducers and cables other than those supplied by the manufacturer is prohibited It could result in increased or decreased emissions or other compromisi...

Page 24: ...r in a clear visible and indelible mode an indication enabling identification of the same manufacturer and the symbol indicating that the product must be disposed of separately Disposal of RAEE waste and disposal rules in EU countries outside Italy or outside the EU As required by national regulations this equipment cannot be disposed of as municipal waste Therefore at the end of its life cycle af...

Page 25: ...20 Diamagnetic Pump 6 2 Guide to the correct maintenance The device must be subjected to annual review and must be carried out by the Periso manufacturer or by qualified personnel from Periso The device must be installed and put into service in accordance with the information contained in this manual Make sure that it is disconnected from the mains during maintenance of the device Do not leave the...

Page 26: ...he supplied bottle Close the cap and reconnect the device to the mains leaving the handpiece lying on the floor Restart the device and let it run for about 10 15 minutes and check that the light is blue green again Turn off the device reposition the handpiece on the arm and restart Check that the magnetic field output is correct Blue green light correct water level in the radiator Red light insuff...

Page 27: ...f the power module are turned on but nothing is shown on the display Make sure the cable connections between the device controller and the power module are correct and Type of Verification Frequency Connection to the mains supply Power on Integrity of neutral plates cables Daily Daily Yes No Integrity of the handpiece cables Integrity of the power supply cable Daily Daily No No Integrity of power ...

Page 28: ... or all items from the display menu when entering the work templates Is the cable between the device controller and the power module is connected properly Check the display of the same functionality in different points Ensure that the display is not greasy or dirty and that there is no cover film The device turns on but the display is not clearly visible Is the cable between the device controller ...

Page 29: ... but the handpiece does not supply the magnetic field output Has a work program been set and has been pressed START on the display The handpiece is properly connected to the power module Check the integrity of the cable Check the integrity of the connector The connection cable is connected correctly to the power module controller Check the correct amount of water in the radiator making sure that t...

Page 30: ...n plate Check the correct amount of water in the radiator making sure that the indicator light is green blue color The red light indicates missing water or below the necessary level If the light is red Turn off the device by unplugging it from the mains Open the tank cap and top up the water in adequate quantities using the fillerspecial toolprovidedwiththe device close the cap place the dispenser...

Page 31: ... the connection connectors are also correct If the problem persists please contact PERISO SA Service and support to send the device to the service center It is obligatory to make a careful description of the problem by sending a written communication to the service center to the following e mail address E mail assistancemed periso ch ...

Page 32: ...ection 2 fuses of 16 A 2 fuses of 3 15 A 1 fuse of 6 3 A 1 thermal magnetic breaker of 10 A Not replaceable by the operator Diathermy Frequency 425 kHz 5 Diathermy power 50W 20 Cooling system Liquid Display Digital Touch Screen display Manufacturer PERISO SA Via Senago 42d 6912 Pazzallo Switzerland CHE 101 514 101 IVA Medical class II A Size 80 x 75 160 cm Weight 96 kg approx Working temperature F...

Page 33: ...CTU MEGA 20 Diamagnetic Pump MOD07 2 5 Rev 13 of 28 08 2019 33 PERISO SA 8 INFORMATION PROVIDED BY THE MANUFACTURER Label of the control module Label of the power module ...

Page 34: ...CTU MEGA 20 Diamagnetic Pump MOD07 2 5 Rev 13 of 28 08 2019 34 PERISO SA Label of the mobile arm Label of the handpiece Serial number label Label on the connector of the handpiece ...

Page 35: ...CTU MEGA 20 Diamagnetic Pump MOD07 2 5 Rev 13 of 28 08 2019 35 PERISO SA Label on the trolley Applied parts connections labels neutral plates M handpiece N ...

Page 36: ...module 30 04 005 o 1 Trolley A155 556 o 1 RS232 cable Environmental conditions storage 30 01 002 o 1 Operating handpiece 30 04 016 o 2 Return plates 30 04 018 o 1 Coated electrode kit 3 pcs Ø 50 Ø 75 Ø 80 30 10 005 o 1 Uncoated electrode kit 3 pcs Ø 50 Ø 75 Ø 80 A2000 013 o 1 Cone electrode 30 04 003 o 1 Shelf Avoid storage in the following cases 30 04 004 o 1 Arm with electric piston A206 016 o 1...

Page 37: ...F RF emissions CISPR 11 Gruppo 1 Group 1 L apparecchioCTU MEGA 20utilizza energiaRFsoloper il suo funzionamento interno Perciò le sue emissioni RF sono molto basse e verosimilmente non causano nessuna interferenza negli apparecchi elettronicivicini The equipment CTU MEGA 20 uses RF energy only for its internal function Therefore itsRFemissions areverylow and are not likely to cause any interferenc...

Page 38: ...00 4 2 eseguita sul connettore del display poiché è presente il simbolo IEC 60417 5134 di sensibilità alle scariche elettrostatiche The floors must be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 The test is not been performed on display connector because the device is provided with IEC 60417 5134 symbol for ESD sensitivity...

Page 39: ...li_cycle per_for 0 5 cicli_cycle Voltage dips short interruptions and voltage variations on power supply input lines 40 UT 40 UT 60 buco in_dip in UV 60 buco in_dip in UV IEC 61000 4 11 per_for 5 cicli_cycles per_for 5 cicli_cycles 70 UT 70 UT 30 buco in_dip in UT 30 buco in_dip in UT per_for 25 cicli_cycles per_for 25 cicli_cycles 5 UT 5 UT 95 buco in_dip in UT 95 buco in_dip in UT per_for 5 sec ...

Page 40: ...s used in such an environment Prova di immunità Immunity Test Livello di prova IEC 60601 IEC 60601 test level Livello di conformità Compliance level Ambiente elettromagnetico Guida Electromagnetic environment Guidance RF condotta Conducted RF IEC 61000 4 6 RF irradiata Radiated RF 3 Veff_Vrms da 150 kHz a 80 MHz 150 kHz to 80 MHz 3 V m 3 V 3 V m Gli apparecchi di comunicazione a RF portatili e mob...

Page 41: ...ssere minore del livello di conformità in ciascun intervallo di frequenza b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Si può verificare interferenza in prossimità di apparecchi contrassegnati dal seguente simbolo Interference may occur in the vicinity of equipment marked with the f...

Page 42: ...isure aggiuntive come un diverso orientamento o posizione dell apparecchio CTU Mega 20 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 electromag...

Page 43: ...o raccomandato in relazione alla potenza di uscita massima degli apparecchi di radiocomunicazione The equipment CTU MEGA 20 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled Thecustomer orthe user ofthe equipment CTU MEGA 20 canhelp prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communicatio...

Page 44: ...CTU MEGA 20 Diamagnetic Pump MOD07 2 5 Rev 13 of 28 08 2019 44 PERISO SA PERISO SA Via Senago 42 d 6912 Pazzallo CH Tel 41 0 919359400 info periso ch www periso ch N IVA CHE 101 514 101 IVA ...

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