User Manual MEGAPULSE IIA
Contents
1. CE Mark showing Do p conformity dispose of as to unsorted 93 42 EEC waste Rated output frequency and power WEEE 2006 96 EC directive i 878 02 03 Type BF equipment 87803 04 non ionising radiation Megapulse ITA Rear panel label 18 Megapulse HA IEC Symbol IEC Symbol 348 Consult accompanying documents Issue 4 Treatment Indicator BNC Socket Label Applicator face for Input treatment area HI Q Applicator CE USE WITH MEGAPULSE IIA ONLY 0120 a MODEL 65A HI Q APPLI CE Mark showing IEC Symbol IEC Symbol conformity to 878 03 04 non 878 03 01 93 42 EEC ionising dangerous radiation voltage inside HI Q Applicator Label Megapulse ITA Iss4 Operating Instructions 1 Connect the Megapulse IIA to a suitable mains supply Attach the Hi Q applicator to the arm and connect it to the output socket using the supplied cable 2 Switch on the unit using the mains switch on the Megapulse control panel The switch will be illuminated and the unit will give a short beep The control panel will display the model number of the unit 65b in the timer section for approximately 2 seconds The default settings zero treatment time VAR mode 20uS pulse width and 50 pulses per second will then be displayed 3 If one of the preset treatments is required the Megapulse ITA may be set ready for use by a single key press using the 1AT 2AT or 4AT button Alternatively the VAR mode2. Handwheels Rear Panel label see page 18 Cablewinders Mains socket and Fuseholder Fuse Label Megapulse ITA Rear View Megapulse IIA Iss4 FUSE 2A TYPE AS 2A AS Megapulse ITA Fuse Label Serial Number and Model Type date of manufacture Company Logo and Name and number L Mains supply an Serial es a A MEGAPULSE IIA Model 65B POWER INPUJ 150 VA CLASS 1 TYPE BF USE WITH MEGAPULSE IIA APPLICATOR ONLY EMS Physio Ltd Wantage Oxfordshire OX12 9FE England www emsphysio co uk This model complies with the technical requirements of PART 18 Subpart C of the F C C regulation WARNING For continued protection against fire replace only with same type and rating of fuse CAUTION This equipment has an output that is capable of producing a physiological effect MAINS SUPPLY 100 240V SUPPLY FREQ 50 60 Hz OUTPUT FREQ 27 12 MHz CE 0120 a RATED OUTPUT POWER 48W INTO 50 ohms CAUTION Conductive material should be excluded from the treatment area CAUTION Hazardous electrical output This equipment is for use by qualified medical personnel anaesthetics DANGER Not for use in the presence of flammable CAUTION High voltage Electric shock hazard Y Disconnect supply cord before removing covers on this equipment Refer servicing to qualified service personnel
3. RF 3V m 3V m d 3 5 P E 80MHz to 800MHz IEC61000 4 3 80MHz to d 7 VP E 800MHz to 2 5GHz 2 5GHz where P is the maximum output power rating of the transmitter according to the manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Co NOTE 1 At 80MHz and 800MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Megapulse IIA is used exceeds the applicable RF compliance level above the Megapulse IIA should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Megapulse IIA P Over the frequency range
4. Unrestricted 5800 5725 5875 Unrestricted 24125 24000 24250 Unrestricted 61250 61000 61500 Under Consideration 122500 122000 123000 Under Consideration 245000 244000 246000 Under Consideration Shortwave therapy equipment normally uses the band centred on 27 12 MHz This corresponds to a wavelength in a vacuum of approximately 11 metres Shortwave therapy is normally applied at a level which produces detectable heating and the benefits are those associated with the heating effect encouragement of healing pain relief reduction of muscle spasm increase in mobility etc Megapulse IIA Iss4 The difference between shortwave therapy and other methods of heating is that it provides deep heat Other heating techniques such as infrared therapy hot packs etc provide the heat externally whereas shortwave therapy generates heat within the tissue As with any electrotherapy there are several potential dangers associated with shortwave therapy Since relatively high powers are used there is the possibility of producing burns if the patient is unaware of the heat due to reduced thermal sensation or if the patient does not know what to expect during treatment Metal in treatment area will provide low impedance paths to the induced radio frequency current producing local heating and the possibility of burning In particular treatment should never be given in the area of metal implants metal jewellery buckles etc must be remove
5. 10kHz to 80Mhz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the Megapulse IIA The Megapulse IIA is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Megapulse IIA can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Megapulse IIA as recommended below according to the maximum output power of the communications equipment 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2 5GHz d 3 5 P V d 3 5VP E d 7 P E 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating in watts W according to the transmitter manufacturer NOTE 1 At 80MHz and 800MlHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Essential Performance Power Input Output Frequency Maximum Output Pulse Widths Puls
6. EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE England User Manual MEGAPULSE ITA Model 65B 0120 Megapulse TA Issue 4 General Information This manual provides the necessary information for the installation and operation of the Megapulse Senior ITA unit These instructions must be studied before putting the unit into operation The information contained in this manual is subject to change without notice No part of this manual may be photocopied reproduced or translated into another language without the prior written consent of EMS Physio Ltd The Megapulse IIA is a pulsed shortwave therapy unit Shortwave therapy been applied to a wide range of conditions with successful outcomes These include acute and subacute traumatic and inflammatory conditions chronic rheumatoid and arthritic conditions resolution of haematomas and for pain relief It is intended that the Megapulse IIA is only used by qualified healthcare professionals such as physiotherapists who have received training in electrotherapy Record of Amendments ISSUE COMMENTS DATE 1 Initial Issue 18 01 2000 2 Revised 17 02 2005 3 EMC Tables added 10 03 2008 4 Updated for model 65B 02 07 2009 Megapulse ITA Iss4 EC Declaration of Conformity EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE United Kingdom Declares that the following medical device is in conformity with the es
7. al sensitivity in the proposed treatment area should not be treated with shortwave therapy Megapulse ITA Iss4 Technical Specification General Power Input Classification EN60601 1 Mains Fuses Size height x width x depth Weight Shortwave Frequency Maximum Output Power Modes 100 240 Vac 50 60 Hz 150VA Class 1 Type BF 2 x T2A 5 x 20 mm 870 x 410 x 410 mm 37 kg excluding HI Q applicator 27 12 MHz 120 kHz 150 W 20 peak power into 50 ohms 1AT 20 min 100us 800Hz fixed 2AT 20min 200us 800Hz fixed 4AT 20 min 400us 800Hz fixed VAR 0 min 65us 100Hz In VAR mode the treatment time pulse width and frequency may be set to the values below Timer Pulse Widths Pulse Frequencies Timer accuracy 0 to 30 minutes in 1 min increments 20 40 65 100 200 400 us 50 100 200 400 600 800 Hz 1 second All information on model serial number and month year of manufacture is located on the rear panel Each Megapulse IIA is supplied with a HI Q applicator treatment chart field detector and this manual The Megapulse IIA has been designed to meet the requirements of BS EN 60601 1 2001 Medical Electrical Equipment Part 1 General requirements for Safety BS EN 60601 2 3 1998 Medical Electrical Equipment Part 2 3 Particular requirements for the safety of shortwave therapy equipment Megapulse TA Issue 4 Output Waveform The pulse width may be set to 20 40 65 100 200
8. ay APPL in the timer display and sound an alarm for approximately 2 seconds the output will not be energised 9 If the output ON OFF button is pressed before the treatment time has elapsed the output will be terminated the treatment lamps on the control panel and applicator will turn off and the timer display will show the remaining treatment time When the ON OFF button is pressed again the treatment will continue 10 The mode pulse width and pulse rate cannot be changed during treatment 11 When the treatment time reaches 00 00 the pulsed shortwave energy from the applicator will be terminated the treatment indicators on the applicator and control panel will turn off and the buzzer will sound 12 If the user requires an audible confirmation each time a key is pressed then the unit should be switched on using the power switch while holding down either the 2AT VAR or pulse rate up button The unit will display Set UP in the timer and pulse width displays followed by bEEP in the timer display and either ON or OFF in the pulse width display Use the pulse width down button to change the setting from OFF to ON or vice versa To exit the set up mode press a timer key The setting will be saved in non volatile memory for future use Megapulse ITA Iss4 21 Maintenance The Megapulse ITA and HI Q applicator may be cleaned by wiping over with a damp cloth The use of abrasive materials and cleaning solvents should be avoided In
9. d and treatment must never be given with the patient on metal framed couches or chairs Patients with implanted electronic devices such as cardiac pacemakers must not be treated Other equipment including patient connected devices may be adversely affected when in close proximity to shortwave therapy equipment Pulsed Shortwave Therapy Conventional shortwave therapy equipment described above produces a continuous wave output at 27 12 MHz Pulsed shortwave therapy equipment delivers the energy in pulses or bursts of shortwave energy The pulses are typically 20 to 400 microseconds in duration pulse width and are repeated with a frequency of 5 to 800 Hz pulse frequency As with other modalities such as ultrasound it is found that delivering the energy in pulses is often therapeutically more beneficial that providing the same amount of energy in continuous wave form Pulsed shortwave therapy appears to be effective for many conditions especially in the early stages of recovery Because the output is pulsed the average output power levels can be very low less than 1W and still produce effective treatment The Megapulse IIA Pulsed Shortwave Unit provides a peak power of 150W and average powers from a few mW to 48W As the power levels are lower than with conventional shortwave therapy equipment some of the potential dangers associated with the modality no longer apply At average powers of less than 5 W treatment may be given over area
10. e Frequencies Timer Timer accuracy 26 100 240 Vac 50 60 Hz 27 12 MHz 120 kHz Power 150 W 20 peak into 50 ohms 20 40 65 100 200 400 us 10 50 100 200 400 600 800 Hz 10 0 to 30 minutes in 1min increments 1 second Megapulse IIA Issue 4
11. ected to the lic low vol Voltage Ralwork Mat supple billings beat fluctuations Gorai Aee pp g Flicker emissions Opies OMES purposes IEC 61000 3 3 Megapulse IIA Iss4 23 Guidance and manufacturers declaration electromagnetic immunity The Megapulse IIA is intended for use in the electromagnetic environment specified below The customer or the user of the Megapulse IIA should assure that it is used in such an environment Electromagnetic Immunity test AE Porte pianos Environment guidance Floors should be wood concrete or Electrostatic 6 kV ceramic tile If floors discharge contact so ky contaci are covered with ESD synthetic material IEC 61000 4 2 8 kV air ae Oga the relative humidity should be at least 30 2 kV for Electrical fast power supply 2 kV for power Mains power quality should be that of a transient burst ines supp y ines typical commercial or IEC61000 4 4 1 KV for AS hospital ieee input output lines environment ae Mains power quality differential i i Surge mode me differential pela be that of ical commercial or on 2 kV 2 kV common ypice IEC61000 4 5 eaten mode hospital ee environment lt 5 UT gt 95 dip in Mains power quality UT should be that of a lt 5 UT Gai di For 0 5 cycle 595 dip in UT Ress hoes or oltage dips 40 UT For 0 5 cycle ospita short 60 dip in E environment If the interruptions UT 40 UT user of the and volta
12. ge For 5 cycles 60 dip in UT Megapulse IIA variations on For 5 cycles requires continued power supply es A 7 70 UT operation during input lines e dip In 30 dip in UT power mains F a For 25 cycles interruptions it is IEC 61000 4 or lt 5 UT recommended that 11 cycles aera the Megapulse IIA be lt 5 UT 35 dipin I powered from an gt 95 dip in FOKS See uninterruptible power UT supply For 5 sec Power frequency magnetic field should Power be at levels frequency characteristic of a 50 60412 SAM A typical location in a Magnetic field pois commercial or IEC 61000 4 8 yp hospital environment NOTE UT is the a c mains voltage prior to application of the test level 24 Megapulse TA Issue 4 Guidance and manufacturers declaration Electromagnetic immunity The Megapulse IIA is intended for use in the electromagnetic environment specified below The customer or user of the Megapulse IIA should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic Environment Test Test level level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Megapulse IIA including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3Vrms 3V d 3 5VP V IEC61000 4 6 150kHz to 80MHz Radiated
13. have occurred in transit If any signs of damage are found then retain all packing material and inform the carrier and the Company or its agent from whom the unit was purchased If not already fitted connect a suitable plug to the mains cable The plug must have provision for an EARTH GROUND connection The mains cable has the following colour code BROWN is LIVE LINE BLUE is NEUTRAL and GREEN YELLOW is EARTH The mains supply must be capable of providing at least 3A 220 240V or 6A 100 120V Attach the HI Q applicator to the end of the treatment arm and lock into place by tightening the sleeve at the end of the arm Connect the HI Q applicator to the socket on the rear panel of the Megapulse ITA using the cable provided Megapulse TA Issue 4 Controls and Markings Megapulse IT l O fa TREATMENT OFF PULSE DURATION v la PULSE RATE P P S v a A A SHORTWAVE DIATHERMY SYSTEM Megapulse II Control Panel Power POWER Mains on off switch Two position rocker up for on down for off The switch is illuminated when the power is on and is marked with IEC Symbols 878 01 01 mains on and 878 01 02 mains off Timer The Timer section of the control panel has a 4 digit 7 segment led display and two push buttons The display show
14. may be selected giving full flexibility of the treatment parameters The current selection is shown by the led indicator above each switch 4 If VAR mode has been selected set the required treatment time using the 10 and 1 buttons in the timer section The maximum treatment time is 30 minutes 5 If VAR mode has been selected set the required pulse width and pulse rate using the up and down buttons in each section the current selection is shown by the 3 digit display above the up and down buttons The average power at each setting is shown on the treatment chart provided with the Megapulse IIA unit and is also shown on page 12 of this manual 6 Slacken the arm handwheels and position the applicator over the treatment site so that the rim around the face of the applicator is about 1cm from the patient Tighten the handwheels to prevent movement Megapulse TA Issue 4 20 7 To start treatment press the ON OFF button in the output section of the Megapulse II control panel The treatment indicator adjacent to the button will light and the timer will begin to count down The treatment indicator on the applicator itself will also light as radio frequency energy is detected in the applicator However if the rate and width are low then the applicator lamp will glow dimly and will not be clearly visible at powers below 12W 8 If the ON OFF button is pressed without the applicator being connected to the output socket then the unit will displ
15. or 400 us The Period may be from 1 25 ms 800Hz to 20 ms 50Hz Envelope of shortwave pulse Pulse Width 1 Period The duty cycle is given by Pulse Frequency Hz x Pulse Width us 10000 Environmental Conditions for Transport and Storage Temperature 10 to 35 C Relative Humidity 5 to 95 Atmospheric Pressure 500 to 1060 hPa Environmental At the end its life the Megapulse IIA should not be disposed of as unsorted general waste Advice on appropriate disposal is available from EMS Physio Ltd For continued safety only electrodes and cables supplied by EMS Physio Ltd should be used with the Megapulse IIA Megapulse IIA Iss4 Treatment Chart _ 400 5 a S 200 2 O S 100 E nN 65 Q z 1 40 nN 5 T 2 50 100 200 400 600 800 PULSES PER SECOND SUB ACUTE resolving 0 15 2 4 W 3 9W above 12 W It is the peak power of the pulsed output which produces the effective treatment However for ease of selecting the control setting the output is expressed in average power watts The chart illustrates the range of powers available for the various conditions to be treated Megapulse ITA Issue 4 Spacing The applicator should be placed with its rim 1 cm from the treatment site thus maintaining a sterile field of treatment Examples of chronic conditions which respond well Disorders of the musculo skeletal system eg degenerative joint disease chrinic rheumatoid arth
16. ritis and osteo arthritis Sprains strains muscle and tendon tears capsule lesions sinusitis pelvic conditions Examples of conditions which respond well in both the acute and sub acute stages ligamentous sprains intramuscular haematoma haemorrhoids oedema post natal conditions episiotomy bruised perineum acute disc lesions periarthritis acute sciatica sinusitis tendinitis teno synovitis pressure sores leg ulcers post operative oedema bursitis Pain relief to osteo arthritis low back pain frozen shoulder ankylosing spodylitis sciatica sinusitis Treatments Treatment times should be between 6 and 15 minutes depending on the required depth and area of treatment The shorter times for areas of small tissue volume hands forearms ankles etc the longer times for larger tissue volume thighs trunk abdomen etc Where possible treat twice daily otherwise at least every two days until the condition improves normally between 4 and 8 treatments should any discomfort occur either during or after treatment it may be due to excessive output for the condition being treated In such case reduce the pulse rate by one setting and continue treatment It is always better to reduce the pulse rate than the pulse width IMPORTANT It is unlikely that any heating effect will be felt by the patient at any treatment setting Megapulse ITA Iss4 13 Installation Upon receipt check for any visible damage which may
17. s containing metal implants through wound dressings or plasters and on couches or chairs with metal frames A list of necessary precautions and contraindications is provided in the following sections Megapulse TA Issue 4 Precautions amp Contraindications Precautions The function of certain implanted electrical devices for example pacemakers may be adversely affected during treatment with pulsed shortwave therapy In case of doubt the advice of the physician in charge of the patient should be sought The function of other patient connected equipment may be adversely affected by the operation of shortwave therapy equipment Hearing aids should be removed Treatment should not be given through clothing although it is permissible to treat through a dressing or plaster External conductive material should be removed from the immediate treatment area however areas containing internal metallic implants may be treated at low power levels less than 5 W average power without special precautions Contraindications Tumours due to the risk of increased growth or metastatic activity Pregnancy do not treat the lower abdomen back or pelvis Menstruation do not treat lower back or abdomen due to risk of increased bleeding or pain Cardiac conditions do not treat the chest area or near the cervical ganglion Cardiac pacemakers especially demand type or any other implanted electronic device Patients with reduced therm
18. s the remaining treatment time in minutes and seconds the buttons are used to set the treatment time in VAR mode the 10 button increases the treatment time by ten minutes and the 1 button increases the treatment time by I minute The maximum treatment time is 30 minutes Output The treatment led indicates that the TREATMENT output of the unit is energised the button toggles the output on and off Megapulse ITA Iss4 15 Mode The 4 mode switches select either one of the 3 fixed treatment programs or VAR the variable mode The mode can only be changed when the output is off Pulse Width The output pulse width is displayed in microseconds on the 3 digit 7 segment display In VAR mode pressing the up arrow button increases the pulse width to the next setting and pressing the down arrow button reduces the pulse width to the next setting Pulse Rate The output pulse rate is displayed in pulses per second Hertz on the 3 digit 7 segment display In VAR mode pressing the up arrow button increases the pulse rate to the next setting and pressing the down arrow button decreases the pulse rate to the next setting Ca IEC Symbol IEC Symbol 878 03 04 348 consult non ionising accompanying radiation documents Megapulse ITA MODE i Ew VAR PULSE DURATION uSEC PULSE RATE P R IEC Symbol 878 02 03 Type BF equipment Issue 4
19. sential requirements and provisions of Council Directive 93 42 EEC and is subject to the procedure set out in Annex 2 of Directive 93 42 EEC under the supervision of Notified Body Number 0120 SGS United Kingdom Ltd Product Name Megapulse ITA Model Number 65B Signature P Ca oe Position Technical Director 2 July 2009 Megapulse TA Issue 4 Contents page Title 1 General Information 3 Record of Amendments 3 Declaration of Conformity to 93 42 EEC 4 Contents 5 Warranty 6 Introduction 7 Precautions amp Contraindications 9 Technical Specification 10 Treatment Chart 12 Installation 14 Controls and Markings 15 Operating Instructions 20 Maintenance 22 EMC Tables 23 Megapulse ITA Iss4 Warranty This EMS Physio Ltd hereinafter called the company product is warranted against defects in materials and workmanship for a period of two years from the date of shipment The Company will at its option repair or replace components which prove to be defective during the warranty period provided that the repairs or replacements are carried out by the Company or its approved agents The Company will consider itself responsible for the effects on safety reliability and performance of the product only if assembly operations re adjustments modifications or repairs are carried out by persons authorised by it only if the product is used in accordance with the instructions for use only if the electrical installation of
20. spect the HI Q applicator cables and connectors periodically for signs of damage especially cable insulation The unit calibration should be checked at least annually The mains fuses are located on the rear panel in a compartment below the mains inlet The compartment cannot be opened unless the mains lead is removed from the IEC socket Information on fuse type and rating is given on the rear panel of the unit and in the Technical Specification section of this manual If the mains fuses continue to blow then EMS Physio qualified Service personnel must be called in There are no user serviceable parts inside the unit and it should not be opened Full servicing instructions are available on request Megapulse IIA Issue 4 22 Guidance and manufacturers declaration electromagnetic emissions The Megapulse IIA is intended for use in the electromagnetic environment specified below The customer or the user of the Megapulse IIA should assure that it is used in such an environment ae Electromagnetic environment Emissions Test Compliance guidance The Megapulse IIA must emit RF emissions Group 2 electromagnetic energy in order to CISPR 11 P perform its intended function Nearby electronic equipment may be affected RF emissions CISPR 11 ica Harmonic The Megapulse IIA is suitable for use in emissions Class A IEC 6100 3 2 all establishments other than domestic and those directly conn
21. the relevant room complies with the appropriate national requirements Should the product be returned to the Company for repair it must be sent carriage paid Consumable items for example electrodes electrode covers and batteries are excluded from the above warranty Megapulse TA Issue 4 Introduction Shortwave Therapy Shortwave refers to electromagnetic radiation in the frequency range 2 to 100 MHz Shortwave therapy is the application of electromagnetic energy to the body at shortwave frequencies At these frequencies the electromagnetic energy is converted to thermal energy by the induction of circulating currents in the tissue and dielectric absorbtion in insulating tissue Shortwave therapy units may produce output power levels of up to 500W providing significant heating to the area of the body being treated For this reason the treatment is often called shortwave diathermy through heating To avoid equipment such as shortwave therapy units interfering with radio communications certain frequency ranges are designated by international agreement as ISM Industrial Scientific and Medical bands These are shown in the following table Centre Frequency Frequency Range Maximum MHz MHz Radiation Limit 6 78 6 765 6 795 Under Consideration 13 560 13 553 13 567 Unrestricted 27 120 26 957 27 283 Unrestricted 40 680 40 66 40 70 Unrestricted 433 92 433 05 434 79 Under Consideration 915 902 928 Unrestricted 2450 2400 2500
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