User Manual THERASONIC 360 & 460
Contents
1. 3 A m 3 A m characteristic of a Magnetic field typical location in a TEC 61000 4 8 typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 30 Primo Therasonic 360 amp 460 Guidance and manufacturers declaration Electromagnetic immunity The Primo Therasonic 360 and 460 are intended for use in the electromagnetic environment specified below The customer or user of the Primo Therasonic 360 or 460 should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Electromagnetic Environment Test level level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Solo Therasonic 360 or 460 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 IEC61000 4 6 150kHz to d 3 5VP V 80MHz Radiated RF 3V m 3V m IEC61000 4 3 d 3 5VP E 80MHz to 800MHz 80MHz to 2 5GHz d 7 P E 800MHz to 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 occur2. C Hie ce T E ULTRASOUND DUAL FREQUENCY E The ultrasound transducers are calibrated independently from the Therasonic 360 or 460 and are fully interchangeable Primo Therasonic 360 amp 460 17 Installation Upon receipt check for any visible damage which may 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 The Therasonic 360 or 460 must only be used with an EMS SLA9000 power supply as supplied with the unit Units fitted with an internal rechargeable battery may be used powered by the battery only The SLA9000 power supply must only be connected to a mains supply with a protective earth conductor If the integrity of the earth connection is in doubt do not connect it to the mains supply The Therasonic 360 or 460 unit is supplied with a large 4 cm transducer An optional small transducer is available for the Therasonic 460 Plug the transducer into the output socket on the front of the unit The plug has a raised square section on the bottom to ensure that it cannot be inserted incorrectly Push the transducer into the holder adjacent to the handle at the rear of the unit Operation of the unit in close proximity less than 1 metre to shortwave therapy equipment or radio frequency mobile communication equipment could result in the ultrasound output of the Therasonic 360 or 460
3. In solids the attenuation is proportional to frequency whereas in liquids the attenuation is proportional to the square of the frequency The usual method of specifying the degree of attenuation of ultrasound in different media is by the half depth The half depth is the distance the ultrasound must travel through the medium for its intensity to be reduced to one half of its original value Many attempts have been made to measure the attenuation in various types of tissue with varying results It is perhaps more important to remember which types of tissue have the highest absorption and which the lowest With the lowest absorption first the order is fat muscle skin tendon cartilage and bone For soft tissue the half depth is around 50 mm at 1 MHz and 15 mm at 3 MHz It is also important to remember that where there is a change in medium or tissue type there will be both reflection and refraction of the ultrasound beam In particular there is almost 100 reflection at the interface of a solid or liquid to air at therapeutic ultrasound frequencies Any air bubbles in coupling medium will therefore reduce the effective intensity of the ultrasound Also bone reflects a high percentage of incident ultrasound It is important therefore when applying ultrasound to keep the transducer orthogonal to the surface of the treatment area to keep the ultrasound transducer moving and to use a good coupling medium to avoid unwanted reflections and locally h
4. and the treatment time will begin to count down Frequency 1 MHz AT AY TREATMENT Move the transducer over the treatment site in small circular paths whilst setting the output intensity to the required level using the rotary control If the transducer is not connected to the output socket or the treatment time is zero then the unit will give a two tone beep and the output will not be energised Always keep the face of the Primo Therasonic 360 amp 460 21 transducer in contact with the treatment area and always keep the transducer moving to avoid any standing waves If the transducer face is lifted from the treatment site or if for any reason there is insufficient contact between the transducer and the treatment site for more than two seconds the power applied to the transducer will also be reduced to a low level The treatment light on the transducer will turn off the treatment time will cease to count down and the status bar will display CONTACT indicating that the required output cannot be delivered When good contact is restored the treatment indicator on the transducer will light the status bar will display TREATMENT and the timer will continue to count down If the output intensity is returned to zero using the rotary control before the treatment time has elapsed the display will show the treatment time remaining When the intensity is increased again the treatment will continue When the treatment time reaches
5. 00 00 treatment is terminated The intensity and power displays will go to zero ultrasonic power from the transducer will be turned off the treatment indicator will turn off and the unit will give a two second beep Remove the transducer from the treatment site wipe off any coupling medium and return the transducer to the holder at the rear of the unit Remove the remaining coupling medium from the treatment site The transducers are also suitable for treatment using a water bath This is especially useful when treating areas which are not uniform such as feet or hands When using a water bath it is advisable to use degassed water water that has been boiled to remove any air and then allowed to cool After the part of the body has been immersed in the water remove any air bubbles that may have accumulated on the skin Set up the treatment parameters and then immerse the transducer in the water before turning the output on Hold the transducer with its face approximately 1 cm away from the treatment site and using the rotary control set the required intensity remembering to keep the transducer moving in small circular paths to prevent standing waves At the end of the treatment the intensity and power displays will read zero and the ultrasound power will turn off Remove the transducer from the water and dry both it and the area treated 22 Primo Therasonic 360 amp 460 System set up menu Touching the Setup button in the bottom right
6. LCD backlight after 1 minute and power itself down completely after 3 minutes if there has been no operator activity and the unit is running off the battery With the exception of the output intensity all set up and treatment parameters are set using the touch screen Ultrasound set up Treatment It is recommended that before commencing treatment the stainless steel front of the transducer is disinfected using a 70 v v aqueous solution of isopropyl alcohol Sterile alcohol wipes are suitable for this purpose Touch the screen on the digits of the time display to increment the treatment time maximum 30 minutes Alternatively touch the clock symbol to bring up the following screen TREATMENT TIME aaa E a J23 minutes CANCEL DELETE ENTER x o Large transducer Type in the desired time and press ENTER to return to the main screen 20 Primo Therasonic 360 amp 460 Select the desired ultrasound Frequency and Mode pulsed or continuous by touching the relevant field on the screen Large transducer Apply sufficient coupling medium to the area to be treated EMS Therasonic coupling medium is recommended Apply the active face of the transducer to the treatment site via the coupling medium Turn the rotary control clockwise to start treatment The output intensity will increase in 0 1 W cm steps The treatment indicator on the transducer will light the output symbol on the LCD will flash
7. being affected 18 Primo Therasonic 360 amp 460 Operating Instructions Operation from external Power Supply Unit Plug the output lead of the power supply into the socket on the rear of the unit and the mains plug to a suitable power outlet The green power indicator on the power supply will light Switch on the unit by pressing and holding the on off switch on the rear panel until the EMS logo is displayed on the LCD D EMS Physio Ltd www emsphysio co uk Therasonic 460 Dual frequency ultrasound Firmware Version 1 00 After approximately 2 seconds the unit will give a short beep and the main ultrasound set up screen will be displayed Frequency 3 MHz At the bottom of the display is the status line On the left is shown which transducer is connected to the output socket On the right the symbol shows that the unit is connected to the mains supply Start up and Main screens will differ according to whether the unit is a Therasonic 360 or 460 Primo Therasonic 360 amp 460 19 If the unit is fitted with a rechargeable battery the battery symbol C will be shown in the status line The symbol is shaded to show the current charge state of the battery indicates a completely discharged battery and a fully charged battery The arrow gt to the left of the battery symbol will be shown if the battery is being charged To conserve battery life the unit will automatically turn off the
8. corner of the main screen takes you to the System set up screen The Contrast button takes you to a screen where you can adjust the display contrast using up down buttons the Volume button allows for adjustment of the beeper volume high or low Language allows you to change the display language to any that may be installed in the unit and Key click allows you to turn on or off the beep that happens whenever the screen is touched Touching the Contact button gives you a screen with three options for the behaviour of the contact alarm On is the default mode where poor contact turns out the contact light and stops the timer countdown Off causes poor contact to turn out the contact light but not stop the timer countdown Audio gives an additional beeping warning light goes out timer stops The About button displays the model number and installed firmware version Primo Therasonic 360 amp 460 23 User programs The Therasonic 360 or 460 can store up to 10 user defined set ups To access the user programs press the User button in the top right corner of the main screen User Programs O05 00 The LCD shows the 10 user programs as file cards with numbered tabs To select a program card just touch its tab To load a program press Load The settings shown on the file card will be loaded and the user will be returned to the ultrasound set up screen If an empty card is selected the unit will give a short beep an
9. in the vicinity of equipment marked with the following symbol o 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 Primo Therasonic 360 amp 460 31 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 Primo Therasonic 360 or 460 is used exceeds the applicable RF compliance level above the Primo Therasonic 360 or 460 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Primo Therasonic 360 or 460 gt Over the frequency range 10kHz to 80Mhz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the Primo Therasonic 360 or 460 The Primo Therasonic 360 and 460 are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the
10. using a 70 v v aqueous solution of isopropyl alcohol They are NOT suitable for steam sterilisation or for disinfectants containing sodium hypochlorite N B Isopropyl alcohol is flammable and should be kept away from naked flames Isopropyl alcohol must not be brought into contact with eyes or mouth The unit may be cleaned by wiping over with a damp cloth isopropyl alcohol wipes can be used to clean the touchscreen The use of abrasive materials and cleaning solvents should be avoided Regularly at least monthly inspect all treatment leads cables and connectors for signs of damage The ultrasonic output power should be checked at least annually Contact EMS Physio Ltd service department for further information The Therasonic 360 and 460 have the option of an internal NiMh rechargeable battery pack EMS161 Whenever the unit is connected to its power supply the battery is monitored and charged as necessary This type of battery has a limited life typically 500 charge discharge cycles This battery pack must only be replaced by authorised service personnel Do not mutilate puncture or dispose of batteries in fire as the batteries can burst or explode releasing hazardous chemicals Discard used batteries according to the manufacturer s instructions and in accordance with your local regulations There are no user serviceable parts inside the unit and it should not be opened Full servicing instructions are available on req
11. 360 or 460 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Primo 360 or 460 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 12 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 800MHz 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 32 Primo Therasonic 360 amp 460 Essential Performance Power Input Ultrasound Frequency Maximum Intensity Maximum Output Power Output Modes Pulse Duration Treatment Timer Large Transducer Small Transducer 100 240V ac 1 1 MHz 5 and 3 4 MHz 5 1 5 W cm 420 in CW 3 0 W cm 20 pulsed modes 6 W 20 average CW and pulsed 1 1 1 2 1 4 and 1 9 2 ms 410 0 to 30 minutes ER
12. 5 Ref to 21 CFR 1050 10 added p 10 25 05 2012 Primo Therasonic 360 amp 460 3 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 essential 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 Class IIb according to Annex IX of 93 42 EEC Product Name Therasonic 460 3601 amp 3603 Model Numbers 120 120A amp 121 121A Signature M Bowles Position Quality Assurance Manager Date 16 March 2012 Date first issued 4 June 2009 Primo Therasonic 360 amp 460 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 Contraindications 9 Technical Specification 10 Controls and Markings 13 Installation 18 Operating Instructions 19 Protocols 26 Dose Algorithm 27 Maintenance 28 EMC Tables 29 Primo Therasonic 360 amp 460 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 prov
13. A 4cm 420 IEC61689 collimated BNR lt 5 ERA 0 6cm 420 IEC61689 divergent at 1MHz ERA 0 4cm 20 IEC61689 collimated at 3MHz BNR lt 5 Primo Therasonic 360 amp 460 33
14. EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE England User Manual THERASONIC 360 amp 460 Models 121A amp 120A 0120 Primo Therasonic 360 amp 460 Primo Therasonic 360 amp 460 General Information This manual provides the necessary information for the installation and operation of the Primo Therasonic 360 and 460 Units 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 Therasonic 360 is a single frequency and the 460 a dual frequency ultrasound therapy unit The units may be mains only or mains battery powered Therapeutic ultrasound has been applied to a wide range of conditions with successful outcomes These include acute and sub acute traumatic and inflammatory conditions chronic rheumatoid and arthritic conditions scar and excessive fibrous tissue and for pain relief It is intended that the Therasonic 360 and 460 units are only used by qualified healthcare professionals such as physiotherapists who have received training in electrotherapy Record of Amendments ISSUE COMMENTS DATE 1 Initial Issue 4 06 2009 2 Revised 20 09 2010 3 Updated for models 120A 121A 08 04 2011 4 Revised declaration of conformity 16 03 2012
15. atment Timer Contact Monitor Large Ultrasound Transducer ERA BNR Beam Type Small Ultrasound Transducer ERA BNR Beam Type 18V 3 33A external PSU Internal Rechargeable NiMh T5A Class 1 Type BF 90 x 230 x 290 mm 1 3 kg excluding battery 10 user defined set ups 14 treatments Calculates treatment settings from user entered parameters 1 1 MHz 5 and 3 4 MHz 5 1 5 W cm in CW 3 0 W cm in pulsed modes 6 W average Mains operation only CW and pulsed 1 1 1 2 1 4 and 1 9 2 ms 0 to 30 minutes treatment linked Light on transducer audio option available 4cm IEC 61689 5 cm 21 CFR 1050 10 lt 5 Collimated 1MHz 3MHz 0 6 cm 0 4 cm lt 5 lt 5 Divergent Collimated Transducers for use with the Therasonic 360 and 460 are fully interchangeable and suitable for underwater treatment IPx7 rated Primo Therasonic 360 amp 460 The Therasonic 360 or 460 power supply is designed to operate from any 50 60 Hz single phase supply between 100 and 240 Vac capable of supplying 50 VA Connection is via an IEC socket on the power supply The serial number and month year of manufacture are located on the bottom of the unit Each Therasonic 360 or 460 is supplied with a power supply and detachable mains cable a 4 cm treatment head 180ml bottle of Therasonic coupling medium and this manual The Therasonic 360 and 460 have been designed to meet the requirements of BS EN 60601 1 2006 M
16. ble intensity will be preset for each protocol to the recommended level for that treatment Before commencing treatment by incrementing the output intensity it is possible to edit the settings if required the maximum available intensity will no longer be preset It is also possible to store an edited version of a protocol as a user program by pressing User and then selecting the program number and the Save option 26 Primo Therasonic 360 amp 460 Dose Algorithm 460 only Press the Dose button to produce this screen Dose Algorithm Lesion Depth 2 0 cm Tissue State Treatment fArea O cm The various parameters can be changed using the Up Down buttons If an Ultrasound transducer is not connected this prompt screen will appear Dose Algorithm Connect transducer Plugging in an Ultrasound head at this point and pressing Next will cause a return to the Dose Algorithm display After adjusting the various parameters press the Select button and the algorithm will calculate and display the treatment settings for that particular set of input parameters The maximum available intensity will also be automatically set to the value calculated by the dose algorithm Again it is possible to edit and or store these settings as described above in the protocols section Increment the output intensity to begin treatment Primo Therasonic 360 amp 460 27 Maintenance The ultrasound transducers may be disinfected
17. d no action will be taken To save the current ultrasound screen set up as a user program select the card to which the set up is to be saved by touching its tab and press Save The settings will be saved and displayed on the selected card To erase a program saved on the current card press Erase Not Used will be displayed on the selected card to confirm the action Select the Quit option to return to the main page Differences between Model 360 and 460 Screens At start up the screen will display the relevant model number As the 360 is a single frequency unit either 1 or 3 MHz its Frequency button will be inactive and will display the set frequency of the unit As the dose algorithm is not implemented on the 360 the Dose button is inactive Protocols are not implemented in the 3603 and the Prot button will also be inactive 24 Primo Therasonic 360 amp 460 Combination Therapy Any stimulator used with the Therasonic 360 or 460 for combination therapy must be Type BF EN60601 1 for continued safety Attach a suitable electrode to the patient near the treatment site and connect it to one output from the 2 way cable from the stimulator Connect one end of the combination therapy lead SLA160 to the stimulator input on the front of the Therasonic 360 or 460 and the other to the remaining output on the 2 way cable of the stimulator It is recommended that only the large transducer is used for combination therapy in order
18. e wave Therefore sound waves are longitudinal waves Longitudinal Wave Compression Rarefaction Compression Rarefaction Compression 7 ee One Wavelength Direction of wave motion The diagram shows a sound wave travelling from left to right The vertical bars represent thin slices of the medium which are displaced to form areas of compression and rarefaction The sinewave represents their displacement relative to their mean position The distance over which the vibration repeats itself is called the wavelength The number of complete vibrations in one second is called the frequency of the sound wave The velocity of sound in the medium is given by Velocity frequency x wavelength Primo Therasonic 360 amp 460 7 Sound will travel faster through media where the molecules are closer together and so the velocity is higher in solids than in liquids and higher in liquids than in gasses For example the velocity of sound in stainless steel is approximately 5800 m s in water 1500 m s and in air only 330 m s As the sound wave passes through the medium causing molecules to vibrate some of the energy in the wave is converted from kinetic energy to heat For a collimated sonic beam the intensity power per unit area therefore decreases exponentially with the distance travelled The attenuation of the beam is also dependent upon the frequency of the sound
19. edical Electrical Equipment Part 1 General requirements for Safety BS EN 60601 2 5 2000 Medical Electrical Equipment Part 2 5 Particular requirements for the safety of ultrasonic physiotherapy equipment Envelope of ultrasound wave a PT Width OF Time see table Pulse Off Duty Temporal peak Mode Frequency Time Cycle to average ratio 1 1 250 Hz 2 ms 50 2 1 1 2 166 Hz 4 ms 33 3 1 1 4 100 Hz 8ms 20 5 1 1 9 50 Hz 18ms 10 10 1 The pulse width is fixed at 2 ms Primo Therasonic 360 amp 460 11 Environmental Conditions for Transport and Storage Temperature 10 to 35 C Relative Humidity 5 to 95 Atmospheric Pressure 500 to 1060 hPa Output Display The Therasonic 360 or 460 display shows the temporal peak spatial average ultrasound intensity and optionally the temporal average power or the temporal peak power as selected Accessories Catalogue Description Number PMA9120 Large Dual frequency Transducer PMA9121 Large Single frequency 1MHz Transducer PMA9130 Small Dual frequency Transducer PMA9150_ Large Angled Dual frequency Transducer SLA9160 Combination Therapy Lead EMS502 EMS Coupling Medium 12 x 170ml bottles EMS502A_ EMS Coupling Medium llitre bottle EMS502B Dispenser Pump for litre bottles EMS530 Primo Shoulder Bag EMS158 Primo Trolley Supplied with each unit is a detachable mains lead complete s
20. ided 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 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 6 Primo Therasonic 360 amp 460 Introduction Sound is mechanical vibration The human ear responds to these vibrations in the range 20 Hz to 20 kHz Sound above 20 kHz is called ultrasound Therapeutic ultrasound is sound in the range 500 kHz to 5 MHz Sound waves are produced by some disturbance in a material medium causing the particles or molecules of the medium to vibrate For this reason sound will not pass through a vacuum If the vibration is continuous and regular a constant tone or frequency is produced The vibration or sound wave propagates through the medium as particles in the medium pass on their vibration to neighbouring particles and series of compressions and rarefactions are produced in the direction of travel of th
21. igh intensities 8 Primo Therasonic 360 amp 460 Contraindications Tumours as ultrasound affects tissue repair and could therefore encourage growth Infections due to the risk of spreading the infection Pregnancy treatment over the pregnant uterus as ultrasound could affect rapidly dividing cells Radiotherapy sites that have received radiotherapy treatment during the last six months Thrombosis and impaired circulation Areas of impaired sensation Haemorrhage due to the risk of increased bleeding including recently controlled bleeding and haematoma Haemophilia Implanted devices such as cardiac pacemakers should be avoided due to the possibility of affecting their operation Also some plastics used in replacement surgery may be affected by absorption of ultrasound energy Metal implants may lead to reflections and as a precaution low doses of ultrasound should be used near these Extreme care should be taken when treating areas near the eye because of the danger of damage to the retina Similarly extreme care should be taken near the ears and reproductive organs Primo Therasonic 360 amp 460 9 Technical Specification General Power Input Battery optional Internal Fuse Classification EN60601 1 Size height x width x depth Weight Treatment Programs Protocols optional Dose Algorithm optional Ultrasound Frequency Maximum Intensity Maximum Output Power Output Modes Pulse Duration Tre
22. ncrete or ceramic El Rosas 6 kV contact 6 kV contact tile If floors are discharge ae ESD covered with synthetic 8 kV air 8 kV air material the relative EEO humidity should be at least 30 2 kV for i power supply 2 kV for power Mains power quality Pleci ical fast lines supply lines should be that of a ansien burs typical commercial or IEC61000 4 4 1 kV for 1 kV for YPici a input output input output lines hospital environment lines 1 kV differential 1 kV differential Mains power quality Surge z mode mode should be that of a TEC61000 4 5 2 kV 2 kV common typical commercial or common mode hospital environment mode lt 5 UT aria i dip i lt 5 UT Mains power quality Sne should be that of a For 0 5 cycle gt 95 dip in UT SE ss Voltage dips For 0 5 cycle typicalcommiefcial or short 4 40 UT i ae hospital environment 3 a ons 60 dip in 40 UT If the user of the 360 m bes ae UT 60 dip in UT and 460 requires EOE tage For 5 cycles For 5 cycles continued operation yatanons i 70 UT 70 UT during power mains ower su me i t li Pp s 30 dip in 30 dip in UT interruptions it 1s put lines ded that th UT For 25 cycles recommended that the IEC 61000 4 11 For 2Seycles lt 5 UT onan UNA lt 5 UT gt 95 dip in UT Por Saa uninterruptible power gt 95 dip in For 5 sec UT supply or a battery For 5 sec Power frequency Power magnetic field should frequency be at levels 50 60 Hz
23. nput A EMS Physio Ltd Oxfordshire England wor emspnysio co tk Fo ULTRASOUND FREQUENCY 1 1 3 4 MHz T ew MODEL 120 120 CLASS 1 TYPE BF IPX1 MAX OUTPU OPTIONAL INTERNALLY POWERED MAXINTENSIT8W em 2 in England Model number and classification Power input On Off requirements switch CE mark Ultrasound IEC Symbol showing frequency 848 01 05 conformity to rated output Stand by 93 42 EEC and intensity 14 Primo Therasonic 360 amp 460 Therasonic 360 or 460 bottom view Description of ultrasound output waveform for each mode Do not dispose of Serial number as unsorted waste and date of 2006 96 EC manufacture WEEE Directive PULSE DURATION one ame 0 167z ij OUTPUT PULSED CONTINUOU Primo Therasonic 360 amp 460 15 Therasonic 360 or 460 top LCD with touchscreen Identity Label 460 IEC Symbol Output 848 01 26 Control knob variability in steps Primo Therasonic 360 amp 460 Large Transducer Treatment Light VEN BOING E A face cart Ano iino nance BEAM TYPE COLLIMATED J RATED OUTPUT 6W ie N BNR 5 0 MAX Z is ee eee N ERA dorm a Small Transducer Treatment Light Active face
24. to maintain sufficient contact area to keep the stimulator current density to a safe level Set up both the ultrasound and the stimulator ready for treatment The stimulator treatment time should be set slightly longer than that for the ultrasound Apply coupling medium to the treatment site and position the ultrasound transducer on patient so that the lesion point is between the stimulator electrode and the ultrasound transducer Turn on the stimulator output and slowly increase the intensity until the patient just feels the normal tingling sensation associated with the modality Turn on the ultrasound output The patient may feel a slight increase to the sensation Increase the ultrasound intensity to the required level Move the ultrasound transducer towards the lesion area making sure that there is always coupling medium between the face of the transducer and the skin When directly over the lesion the patient will feel increased sensation this is the centre of the lesion Treat with ultrasound and stimulation for the remaining time set Primo Therasonic 360 amp 460 25 Protocols 3601 amp 460 only Treatment Protocols Pressure Ulcers 1 of 14 Pressing the Prot button will bring up the protocol selection screen The various different treatment protocols can be selected by the Up Down buttons Pressing the select button will load the treatment settings for the selected protocol Note that the maximum availa
25. uest 28 Primo Therasonic 360 amp 460 EMC Tables 1 Guidance and manufacturers declaration electromagnetic emissions The Primo Therasonic 360 and 460 are intended for use in the electromagnetic 2 environment specified below The customer or the user of the 360 or 460 should assure that it is used in such an environment Voltage fluctuations 8 Flicker emissions IEC 61000 3 3 not applicable 3 Emissions Test Compliance Electromagnetic environment guidance The 360 and 460 use RF energy only for pee their internal function Therefore their RF RF emissions teed 4 Group 1 emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment RF emissions cIsPR11 caa 7 er not applicable The 360 and 460 are suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Primo Therasonic 360 amp 460 29 Guidance and manufacturers declaration electromagnetic immunity The Primo Therasonic 360 and 460 are intended for use in the electromagnetic environment specified below The customer or the user of the 360 or 460 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic Environment guidance Floors should be wood co
26. uitable for the country to which it is delivered Replacement or additional mains leads are shown below EMS Part Number Description 6 85 UK mains lead 6 112 European mains lead 6 119 North America mains lead For other countries contact EMS Physio Ltd or the agent from whom the unit was purchased 12 Primo Therasonic 360 amp 460 Controls and Markings Therasonic 360 or 460 front panel IEC Symbol Output 878 01 36 Stimulator Socket Input input LG T STIMULATOR INPUT mA KO IEC Symbol 7000 1641 consult instructions for use IEC Symbol IEC Symbol 878 02 03 878 01 37 IEC Symbol 348 Type BF Output Attention consult Equipment accompanying documents The output socket is for connection of the ultrasound transducer The stimulation input is internally connected to the face of the ultrasound transducer and is intended for combination therapy Any stimulator connected to the socket must be classified as type BF according to EN 60601 1 for continued safety A suitable connecting lead is available from EMS Physio Ltd Primo Therasonic 360 amp 460 13 Therasonic 360 or 460 rear panel IEC symbol 348 Name and Ultrasound symbol Attention consult address of according to Health accompanying manufacturer and Welfare Canada documents safety code 23 Power i
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