User Manual COMBINATION 855
Contents
1. A 1 kV for 1 kV for input output typical commercial or IEC61000 4 4 input output lines hospital environment lines 1 kV A differential Mains power quality g mode 1 kV differential mode should be that of a PE 2 kV 2 kV common mode typical commercial or IEC61000 4 5 common hospital environment mode lt 5 UT gt 95 dip in UT lt 5 UT For 0 5 cycle gt 95 dip in UT KEN E bcs dips 40 UT For 0 5 cycle typical commercial or shot 60 dip in 40 UT hospital environment If interruptions UT 60 dip in UT the user of the 855 eae For cycles For 5 cycles requires continued powersupply 70 UT 70 UT operation during power input lines 30 dip in 30 dip in UT mains interruptions it is UT For 25 cycles recommended that the Ec e1000 4 11 For25eyoles cse ur e lt 5 UT gt 95 dip in UT supply or a battery gt 95 dip in For 5 sec i UT For 5 sec Power frequency ae magnetic field should be at levels characteristic of ya ig Sum SAM a typical location in a IEC 61000 4 8 typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Combination 855 67 Guidance and manufacturers declaration Electromagnetic immunity The Solo Combination 855 is intended for use in the electromagnetic environment specified below The customer or user of the Solo Combination 855 should assure that it is used in such2. 1 cycle of pulse frequency In burst mode the burst rate is 2 Hz for pulse frequencies greater than 20 Hz and the pulse frequency divided by 10 for frequencies less than 20 Hz The duty cycle of the burst is 50 In surge mode the surge rate is 10 per minute 26 Combination 855 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 Combination 855 display shows the temporal peak spatial average ultrasound intensity and optionally the temporal average power or the temporal peak power as selected All information on model serial number and month year of manufacture is located on the rear panel The Combination 855 has been designed to meet the requirements of BS EN 60601 1 1990 BS5724 Part 1 1989 Medical Electrical Equipment Part 1 General requirements for Safety BS EN 601 2 5 2000 Medical Electrical Equipment Part 2 5 Particular requirements for the safety of ultrasonic physiotherapy equipment and BS EN 60601 2 10 1998 Medical Electrical Equipment Part 2 10 Particular requirements for the safety of nerve and muscle stimulators Accessories Catalogue Description Number SLA9000 DC Power Supply 18V 60W SLA9120 Large Dual frequency Transducer SLA9130 Small Dual frequency Transducer SLA9150 Large Angled Dual frequency Transducer EMS502 EMS Coupling Medium 12 x 170ml bot
3. 4 cm lt 5 Collimated 1MHz 3MHz 0 6 cm 0 4 cm lt 5 lt 5 Divergent Collimated Transducers for use with the Combination 855 Therasonic 355 and 455 are fully interchangeable and suitable for underwater treatment IPx7 rated 16 Combination 855 Envelope of ultrasound wave eee Pulse Width OF Time see table Pama gt 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 Interferential 4 pole Carrier Frequency AMF Swing Pattern Vector Output type Output Channels Interferential 2 pole Carrier Frequency AMF Swing Pattern Output type Output Channels 2 kHz 4 kHz or 8 kHz 0 250 Hz in 1 Hz increments 111 616 or 6 6 10s 20 both channels CC 0 100mA peak CV 0 70V peak 2 2 kHz 4 kHz or 8 kHz 0 250 Hz in 1 Hz increments 111 616 or 6 6 CC 0 100mA peak CV 0 140V peak 1 channel 0 70V peak 2 channels 1 or2 Combination 855 17 Russian Stimulation Carrier Frequency Modulation Frequency Surges Output type Output Channels TENS Waveform Pulse Width Repetition Rate Modulation Output type Output Channels Diadynamic Currents Current Types Polarity Output type Output Channels Sinusoidal Frequency AMF Surge Rate Surge Pattern Output Type Output Channels Faradic Frequency Surge Rate Surge
4. At the bottom of the screen is the status bar E Power The left side of the status bar shows the current power source 36 Combination 855 The right side shows the battery status If the unit has a battery installed then the status bar shows an estimate of the remaining battery capacity zs Battery not installed Battery capacity 99 Battery capacity 93 and charging Standard key functions Throughout the operation of the Combination 855 the up and down keys are used to select the parameter highlighted The rotary control is used to increase and decrease the highlighted parameter except for Ultrasound power which has its own dedicated up and down keys this is to enable simultaneous control of both Ultrasound power and Stimulation intensity when in Combination mode Pressing the Ultrasound keys together returns ultrasound power to zero The menu key is used to exit from the current screen or to select the menu option highlighted Combination 855 37 Ultrasound From the system menu screen scroll to highlight Ultrasound and press the menu key The Ultrasound set up screen will appear Ultrasound set up E Power Ultrasound set up screen Treatment Time When the ultrasound set up screen is first displayed the clock symbol is highlighted With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s interv
5. 33 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 Combination 855 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 Combination 855 unit is supplied with a large 4 cm ultrasound transducer and four medium sized electrotherapy electrodes with their associated patient lead An optional small transducer is also available Plug the ultrasound transducer into the output socket on the front right of the unit and the patient lead into the one to its left Each plug has a raised square section on the top 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 Combination 855 being affected 34 Combination 855 Operating Instructions Operation from external PSU Plug the PSU into the socket on the rear of the unit and to a suitable power outlet The unit will turn on in stand by mode indicated on the LCD and the power indicator on the top panel will flash ev
6. is produced To set the AMF or beat frequency first highlight Base using the up and down keys The base frequency may be set in 1 Hz increments using the rotary control from 1 to the current setting of the peak frequency Press the down key to highlight the Peak Set the peak frequency using the rotary control The peak frequency may be set in 1 Hz increments from the base frequency to 250 Hz Patt Pattern The pattern determines the rate at which the beat frequency sweeps between the base and peak frequencies Three patterns are available The 111 pattern gives 1 second at the base frequency followed by 1 second at the peak frequency The 616 pattern gives 5 seconds at the base frequency sweeps linearly to the peak frequency in seconds followed by 5 seconds at the peak 42 Combination 855 frequency and finally sweeps back to the base frequency in second The 6 6 pattern sweeps from the base to the peak frequency in 6 seconds and the sweeps back to the base frequency in 6 seconds To change the pattern use the rotary control when Patt label is highlighted Vector When the vector option is set to off output channels A and B deliver the same output level current or voltage When the vector option is on the relative amplitude of the outputs is slowly varied Over 5 seconds the output of channel A will increase smoothly from 80 of its nominal amplitude to 100 while the output of channel B falls from 100 to 80 During the next
7. 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 one 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 Ultrasound keys set the required intensity remembering to keep the transducer moving in small circular paths to prevent standing waves At the end of the treatment turn off the output control remove the transducer from the water and dry both it and the area treated 40 Combination 855 Stimulator From the system menu screen scroll to highlight the Stimulator option Pressing the menu button will cause the following Stimulato
8. 1 metre to shortwave or microwave therapy equipment may produce instability in the stimulator output Consideration must be given to the current densities for any electrode used with the Combination 855 Unit Current densities greater than 2 mA rms cm are not recommended because of the risk of burning All the standard EMS conductive rubber electrodes may be used up to the maximum output of the unit without exceeding this figure When using other electrodes the maximum safe output current should be assessed before use First estimate the effective contact area of the electrode in square cm and then apply the following formula rms output current mA Area of electrode cm x 2 The ratio of the rms to the peak current for the different operating modes is given in the technical specification section of this manual The output indication on the LCD shows the peak output voltage or the peak output current in mA depending upon the selected mode of operation When using direct current extreme care must be taken to ensure the patient s safety from electrochemical burning In particular care must be taken to avoid uneven pressure on the electrodes causing high local current density Electrodes must not be applied where there are cuts or abrasions Combination 855 13 Contraindications Ultrasound Tumours as ultrasound affects tissue repair and could therefore encourage growth Infections due to the risk of spreading the infect
9. Pattern 18 2 5 kHz 1 100 Hz 1 1 to 1 5 CC 0 100mA peak CV 0 140V peak 1 channel 0 70V peak 2 channels lor2 Asymmetrical Symmetrical or Sequential 20 400 us 1 250 Hz None Burst or Surged CC 0 100mA peak CV 0 60V peak 2 DF MF CP CPiso RS LP Positive or Negative CC 0 70mA peak CV 0 140V peak 1 50 Hz 2 to 30 minute Rectangular Triangular or Trapezoidal CC 0 70mA peak CV 0 140V peak 1 50 Hz 2 to 30 minute Rectangular Triangular or Trapezoidal Combination 855 Output Type Output Channels Galvanic Output Type Output Channels Interrupted Galvanic Pulse Width Waveform Pulse Rate Output Type Output Channels Tr bert Waveform Output Type Output Channels Medi Wave Waveform Frequency Modulation Output Type Output Channels CC 0 70mA peak CV 0 140V peak CC 0 70mA peak CV 0 140V peak 10 us to 1 s for rectangular 1 ms to 1 s for other shapes Rectangular Triangular or Trapezoidal 1 to 30 minute CC 0 70mA peak CV 0 140V peak 1 2 ms on 5ms off rectangular CC 0 70mA peak CV 0 140V peak 1 6 ms differentiated pulse 2 60 Hz None Burst Surged CC 0 70mA peak CV 0 140V peak 1 channel 0 70V peak 2 channels lor2 Combination 855 19 Output Waveforms Interferential 4 pole N Faa A cycle EN AN ye fj A i Channel A XT cycle 7 cycle A oe S os Poe i Channel B Channel A Channel B Car
10. a program saved on the current card highlight the Erase option using the up and down keys Pressing the menu key will erase the program Not Used will be displayed on the selected card to confirm the action Select the Quit option to return to the system menu Combination 855 59 Set up The set up option is accessed from the system menu by scrolling down below the User Programs tab highlighting Set Up and pressing the menu key This option allows user preferences to be set for LCD contrast sounder volume key click language and contact monitor Contrast When the contrast label is highlighted turning the rotary control clockwise makes the LCD darker and wo Lane key click anticlockwise makes it lighter language Ena contact aug Volume There are two volume levels aE Power for the sounder When volume is highlighted turning the rotary control clockwise sets high and anticlockwise sets low W Key click When key click is highlighted turning the rotary control clockwise sets the key click on and a short beep is produced each time a key is pressed Turning the rotary control anticlockwise turns the key click off Language When language is highlighted the rotary control changes the current display language Contact The ultrasound contact monitor can be set to produce an audible alarm when there is insufficient contact for the correct ultrasound power to be delivered In this option turning the rotary control c
11. between the stimulator electrode s and the ultrasound transducer Highlight the stimulator output turn it on using the control knob and slowly increase the intensity until the patient just feels the normal tingling sensation associated with the modality Turn on the ultrasound output using the ultrasound buttons 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 56 Combination 855 Electrodes It is recommended that only electrodes supplied by EMS Physio Ltd are used with the Combination 855 Three sizes of conductive rubber electrodes are available These are small 70 x 50 mm medium 100 x 70 mm or large 130 x 100 mm Replacement sponge covers are available for each electrode In most applications it is sensible to use as large an electrode as is practical for the area of the body being treated This will also reduce the possibility of any adverse effects at the site of the electrode due to high current density Inspect the area to be treated to ensure there are no open wounds areas of infection abrasions etc Wash the skin in war
12. example if the ratio is set to 1 4 then the work period is 10 seconds and the rest period is 40 seconds Highlight the ratio label and use the rotary control to set the ratio to any integer value between 1 1 and 1 5 44 Combination 855 Channels 1 or 2 output channels are available When the channels label is highlighted turning the rotary control clockwise selects 2 channel operation and anticlockwise selects single channel operation Note that in 2 channel operation all settings for the two channels are the same including the output level CC CV The output may be set to be constant current CC or constant voltage CV In constant current mode the electrode impedance is monitored and if the impedance for either channel is too high then the output is terminated and an alarm sounded In constant voltage mode if the electrode impedance rises then the output current is automatically reduced TENS Set up When the TENS set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown TENS Treatment Time With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals POE m Type Three waveform types are available and each type is represented 1 Symmetrical Ilr Asymmetrical sle Taah Sequential us The pulse width may be set from 20 to 400 us in 5 us incremen
13. pulse period 1 repetition rate TENS Burst mode For repetition rates greater than 20 Hz the TENS output is on for 0 25 s and off for 0 25 s 2 Hz burst frequency For repetition rates less than 20 Hz the on and off times are 5 pulse periods TENS Surge Mode For repetition rates greater than 5 Hz the TENS output is zero for 2 s rest then increases to the set level during the next 1 s rise remains at the set level for 0 5 s hold and returns to zero during the next 0 5 s fall giving a surge rate of 15 minute Below 5 Hz the rest rise hold and fall times are 10 5 3 and 2 pulse periods respectively 22 Combination 855 Diadynamic In diadynamic mode the unit produces six different waveforms The maximum peak output current is limited to 70 mA DF diaphas fixe The DF waveform is a continuous full wave rectified 50 Hz sinewave 10ms rms current peak current x 0 707 The maximum rms current is 50 mA MF monophas fixe The MF waveform is a continuous half wave rectified 50 Hz sinewave lt gt 20ms rms current peak current x 0 5 The maximum rms current is 37 5 mA CP modul en courtes p riodes The CP waveform is a combination of the MF and DF waveforms The unit provides 1 s of MF half wave signal followed by 1 s of DF full wave signal the sequence being repeated continuously CPiso modul en courtes p riodes isodynamique This is the same as the CP waveform except that th
14. symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals Surge Three surge patterns envelopes are available Rect rectangular Tri triangular and Trap trapezoidal A full description of these surge patterns is available in the technical specification section of this manual The surge pattern may be changed using the rotary control when the surge label is highlighted Rate Surge rates of 2 5 10 20 and 30 per minute are available The surge rate may be changed using the rotary control when the rate label is highlighted CC CV The output may be set to be constant current CC or constant voltage CV Galvanic Set up When galvanic is selected from the system menu the mode is shown at the top right of the screen GAL The only available options are treatment time and CC CV which are set in exactly the same way as the other operating modes Power Combination 855 49 Interrupted Galvanic Set up When the Interrupted Galvanic set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown INT G Treatment Time With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals idth isms Rate 2 Min ae Power Form Three different pulse shapes are a
15. to Dose Algorithm and pressing the menu button produces this screen Dose algorithm The lesion depth in cm can be Derth 1 5 Back changed using the rotary control W1 Lesion Derth com ae Pee wen 100 If an Ultrasound transducer is not connected this prompt screen will appear Dose algorithm Connect Plugging in an Ultrasound head at Transducer this point will cause a return to the Lesion Depth display menu to uit Power ma i00 Set the required lesion depth and press the menu button This next screen will appear Dose algorithm t acute S chroni Power me 100 Combination 855 63 Select the relevant state using the rotary control and press the menu button This final screen will appear After adjusting the treatment area using the rotary control press the menu button and the algorithm will Lesion area cm calculate and display the treatment ge Foer Fmi 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 64 Combination 855 Maintenance The ultrasound transducers electrodes and covers may be disinfected using a 70 v v aqueous solution of isopropyl alcohol They are NOT suitable for steam sterilisation or for disin
16. 008 4 Protocols and Dose Algorithm added 27 04 2010 5 Revised 28 02 2010 Combination 855 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 Product Name Combination 855 Model Number 118 Signature D D A Position Technical Director Date first issued 18 02 08 Combination 855 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 14 Technical Specification 16 Controls and Markings 29 Installation 34 Operating Instructions 35 Protocols and Ultrasound Dose Algorithm 61 Maintenance 65 EMC Tables 66 Combination 855 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 it
17. 5 seconds A will return to 80 and B will rise to 100 and so on The effect is to move the physical location of the point of maximum stimulation in the tissue and therefore increase the treatment area To change the vector option highlight the vector label using the up and down keys Turning the rotary control clockwise sets the vector option to on and anticlockwise off CC CV The output from the unit may be set to be constant current CC or constant voltage CV in nature In constant current mode the electrode impedance is monitored and if the impedance for either channel is too high then the output is terminated and an alarm sounded In constant voltage mode if the electrode impedance rises then the output is automatically reduced Normally constant current mode would be used If the unit is used for combination therapy or with internal electrodes vaginal or anal then constant voltage is recommended 2 pole Interferential Set up 2 pole interferential therapy is similar to 4 pole interferential except that the two medium frequencies are added together in the stimulator itself and applied to the treatment site through a single pair of electrodes At the top right of the screen the current mode is shown IT 2p interferential therapy 2 pole Power Combination 855 43 The 2 pole interferential set up is similar to the 4 pole set up The treatment time MF carrier frequency base and peak frequencies pattern and C
18. C CV operation are set up in exactly the same way There is no vector option in the 2 pole interferential mode Chnls Channels In addition to the normal 2 pole interferential operation the Combination 855 can provide two separate channels of 2 pole interferential stimulation at the same time The number of channels can be selected when the chnls label is highlighted Turning the rotary control clockwise selects 2 channel operation and anticlockwise selects single channel operation Note that in 2 channel operation all settings for the two channels are the same including the output level Russian Set up When the russian stimulation set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown RUSS Russian stimulation Treatment Time With the clock symbol highlighted turn the rotary RUSS control clockwise to increase the gt N m time and anticlockwise to decrease MHO the time The time can be set in 30s intervals Burst The burst frequency may be Power set from 1 Hz to 100Hz With the burst label highlighted rotating the rotary control clockwise increases the burst frequency and anticlockwise decreases the burst frequency Ratio The medium frequency bursts used for Russian stimulation are surged to produce work and rest periods The surge time work is fixed at 10 seconds The ratio sets the off or rest time in ratio to the work period For
19. EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE England User Manual COMBINATION 855 Model 118 0120 Combination 855 General Information This manual provides the necessary information for the installation and operation of the Combination 855 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 Combination 855 unit is a dual frequency ultrasound therapy unit and a multiple waveform electrotherapy unit in one box Both modalities may be used individually or in combination Therapeutic ultrasound has 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 scar and excessive fibrous tissue and for pain relief The 855 also provides a complete range of low and medium frequency waveforms for electrotherapy and electro diagnostics It is intended that the Combination 855 unit 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 25 01 2008 2 EMC Tables added 31 01 2008 3 Updated 08 08 2
20. ENTION ULTRASONS FREQUENCY 1 4 34 MHz MAX OUTPUT ew MAX OUTPUT 100mAfpk 250V pf pk USE ONLY EMS MAX INTENSITY 3Wicm INTERFERENTIAI POWER SUPPLY CHANNEL A REF SLA9000 CHANNEL B 2kHz Mi AkHz 3 75fikHz 8kHz POWER IN 7 7F8kHZ Ultrasound frequency rated output and intensity Inteferential frequencies and rated output Serial number and date of manufacture Do not dispose of E A MAX IEC symbol 348 Attention consult accompanying documents as unsorted waste 2006 96 EC WEEE Directive Power connection is via the socket on the right of the rear panel 30 Combination 855 Combination 855 top LCD up and down IEC Symbol menu key keys 848 01 26 variability in steps a Power IEC Power Ultrasound Control knob key Symbol indicator Intensity 848 01 05 Stand by Combination 855 31 Large Transducer Treatment Light Active face Small Transducer Treatment Light Active face The ultrasound transducers are calibrated independently from the Combination 855 and are fully interchangeable 32 Combination 855 Patient Lead SLA3055 lt 4 Electrode connecting cables FOR USE WTH EMS STIMULATORS Combination 855
21. 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 Solo Combination 855 is used exceeds the applicable RF compliance level above the Solo Combination 855 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Solo Combination 855 P Over the frequency range 10kHz to 80Mhz field strengths should be less than 3 V m 68 Combination 855 Recommended separation distances between portable and mobile RF communications equipment and the Solo 855 The Solo 855 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the 855 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Solo 855 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 5 P 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 applicab
22. V 0 70V peak 2 channels 10 into 2 kohms Russian Stimulation Carrier Frequency 2 5 kHz 5 Modulation Frequency 1 100 Hz 5 Surges 1 1 to 1 5 Output type CC 0 100mA peak 10 into 500 ohms CV 0 140V peak 1 channel 10 into 2 kohms CV 0 70V peak 2 channels 10 into 2 kohms 70 Combination 855 TENS Waveform Pulse Width Repetition Rate Output type Diadynamic Currents Current Types Output type Sinusoidal Frequency AMF Surge Rate Surge Pattern Output Type Faradic Frequency Surge Rate Surge Pattern Output Type Galvanic Output Type Interrupted Galvanic Pulse Width Waveform Pulse Rate Output Type Tr bert Waveform Output Type Asymmetrical Symmetrical or Sequential 20 400 us in 5 us increments 10 1 250 Hz in 1 Hz increments 10 CC 0 100mA peak 10 into 500 ohms CV 0 60V peak 10 into 2 kohms DF MF CP CPiso RS LP CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms 50 Hz 45 2 to 30 minute 10 Rectangular Triangular or Trapezoidal CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms 50 Hz 45 2 to 30 minute 10 Rectangular Triangular or Trapezoidal CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms 10 us to 1 s 5 for rectangular in 1 2 5 sequence 1 ms to 1 s 45 for other shapes R
23. als Frequency When the freq label is highlighted turning the rotary control clockwise selects 3 MHz operation and anticlockwise selects 1MHz operation Mode The Combination 855 unit provides both continuous wave and pulsed ultrasound When the mode label is highlighted turning the rotary control clockwise increases the pulse ratio and anticlockwise decreases the pulse ratio Power The displayed output power may be the temporal peak power or the temporal average power In continuous mode these are the same but for pulsed modes the temporal average power is the temporal peak power multiplied by the duty cycle of the pulse When the power label is highlighted turning the rotary control clockwise selects temporal average power and anticlockwise selects temporal peak power 38 Combination 855 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 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 Press the Ultrasound Up key to start treatment The output intensity will increase in 0 1 W cm steps Holding the Up key pressed down will automatically cycle the power upwards The treatment indicator on ers the transducer
24. 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 Solo Combination 855 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 RF 3V m 3V m d 3 5VP 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 o NOTE 1 At 80MHz and 800MlHz 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
25. ay 4000 Hz is applied to one pair of electrodes and a slightly different frequency of say 3900 Hz is applied to the other pair These two frequencies interfere to produce an amplitude modulated medium frequency beat frequency in the tissue The tissue responds to the cyclic rise and fall in the current intensity It is the amplitude modulation frequency AMF that is within the normal biological frequency range and not the medium frequency carrier Russian stimulation was developed by Dr Y Kotz and uses 2 5 kHz sinewaves pulse at a low frequency typically 30 to 80 Hz to produce comfortable muscle contraction It is similar to a surged 2 pole interferential waveform Transcutaneous electrical nerve stimulation TENS refers to the application of low intensity short duration pulses for the purpose of relieving pain The Combination 855 provides two channels of 10 Combination 855 asymmetric symmetric or sequential output with a wide range of pulse widths and repetition rates Combination Therapy In general terms combination therapy involves the simultaneous application of ultrasound with an electrical stimulation therapy In Europe diadynamic currents are frequently used but in the UK ultrasound is most often combined with two pole interferential therapy By combining ultrasound with an electrotherapy the advantages and effects of each treatment modality can be realised but lower intensities are needed to achieve the same
26. brile conditions Large open wounds in treatment area Dermatological conditions in treatment area Thrombosis Hypersensitivity or fear of electrical treatments Any patient who cannot understand the nature of the treatment for example young children very old or senile patients who cannot report back adequately or understand the potential dangers This may apply equally to persons who do not speak the same language as the therapist Severe hypotension hypertension do not treat in the region of the lower cervical spine If in doubt the patient s physician should be consulted Electrodes should never be placed so that the applied current crosses the chest Combination 855 15 Technical Specification General Power Input Battery optional Classification EN60601 1 Fuse Size height x width x depth Weight Treatment Programs Ultrasound Frequency Maximum Intensity Maximum Output Power Output Modes Pulse Duration Treatment 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 Class 1 Type BF Internal TSA 100 x 240 x 210 mm 2 2 kg excluding battery 10 user defined set ups 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 PSU 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
27. cularly used in combination therapy where the ultrasound head becomes one electrode and this switch will change the polarity of the stimulator waveform relative to the ultrasound head CC CV The output may be set to be constant current CC or constant voltage CV Combination 855 47 Sinusoidal Set up When the sinusoidal set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown SIN Treatment Time With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals Surge Three surge patterns envelopes are available Rect rectangular Tri triangular and Trap trapezoidal A full description of these surge patterns is available in the technical specification section of this manual The surge pattern may be changed using the rotary control when the surge label is highlighted oe Power Rate Surge rates of 2 5 10 20 and 30 per minute are available The surge rate may be changed using the rotary control when the rate label is highlighted CC CV The output may be set to be constant current CC or constant voltage CV 48 Combination 855 Faradic Set up When the faradic set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown FAR Power x Treatment Time With the clock
28. e system menu except during treatment tern Menu Highlight the required option using the up and down keys and then press ue menu Combination Protocols Power Scrolling down below the Protocols tab reveals the user programs and Set Up tabs Lem Menu Combination Frotocals User Programs Power User programs The Combination 855 unit can store up to 10 user defined set ups To access the user programs select the option from the system menu User Programs The LCD shows the 10 user programs as file cards with the first program at the front To move through the program cards use the rotary control On entry to the user program display the Load option is highlighted Power 58 Combination 855 To load the displayed program press the menu key The settings shown on the file card will be loaded and the user will be returned to the relevant set up screen If an empty card is selected the unit will give a short beep and no action will be taken User Frograms To save the current Ultrasound or Stimulator set up as a user program select the card to which the set up is to be saved using the rotary control Highlight the Save option using the up and down keys and press the menu key The options will be displayed to save either the current Ultrasound set up or that of the Stimulator Select US or STIM press menu and the set up will be saved and displayed on the selected card Power To erase
29. e amplitude of the MF signal is 12 5 less than the amplitude of the DF signal Combination 855 23 LP modul en longues p riodes The LP waveform provides an MF signal for 5 seconds Then over the next 2 5 seconds the other phase of the 50Hz rectified signal is smoothly increased in amplitude to give a DF signal for a further 5 seconds Finally the signal returns to MF by smoothly reducing one phase of the rectified signal over the next 2 5 seconds The complete sequence takes 15 seconds Part of the LP waveform showing how the alternate phase increases in amplitude is shown below OSs LLIN 20ms RS rythme syncop The RS waveform is second of MF followed by second of zero output this sequence being repeated continually Polarity The above waveforms exhibit ve polarity as they all travel above the ground zero volt level equivalent to the flat part of the waveforms The polarity switch enables the user to reverse this ve so that the above waveforms would be rendered upside down This feature is particularly useful in Combination mode when the Ultrasound head becomes one electrode and we can select the polarity of the waveform relative to the head Sinusoidal In sinusoidal mode the output is an amplitude modulated medium frequency 4kHz with 50 Hz sinusoidal beat frequency The amplitude is determined by the output level setting and the surge type and rate The maximum output is 140 V or 70 mA peak Fo
30. ectangular Triangular or Trapezoidal 1 to 30 minute 10 CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms 2 ms on 5 5ms off 5 rectangular CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms Combination 855 71 Medi Wave Waveform Frequency Output Type 72 6 ms 5 differentiated pulse 2 60 Hz 5 CC 0 70mA peak 10 into 500 ohms CV 0 140V peak 410 into 2 kohms 1 channel CV 0 70V peak 10 into 2 kohms 2 channels Combination 855
31. ed in the direction of travel of the wave Therefore sound waves are longitudinal waves Longitudinal Wave Compression Rarefaction Compression Rarefaction Compression 7 My 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 Combination 855 7 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 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 fr
32. effect Also the accommodation effects that normally accompany electrotherapy are reduced or even eliminated The main advantages of such a combination are said to be in localising lesions especially chronic ie diagnostic use in ensuring accurate localisation of ultrasound treatment to provide increased accuracy effectiveness in treating deeper lesions in treating trigger points Possible Explanations It would appear that by applying ultrasound to peripheral nerves their threshold of stimulation is reduced thus making them more sensitive or excitable It is likely that this effect is brought about by the alteration of the ion pump activity predominantly Na and K but also Ca By altering the transport of these ions across the cell membrane the resting potential will be altered and in this case it would seem that it results in a reduced threshold for depolarisation It is reasonable to expect that this effect occurs in other tissue apart from nerve although no direct evidence has been noted to date Combination 855 11 When electrotherapy is applied simultaneously with ultrasound through the same tissues a reduced intensity is required in order to achieve the same physiological therapeutic effects when compared with electrotherapy in isolation This can easily be demonstrated by turning off the ultrasound component whilst continuing with the electrotherapy The patient very soon becomes aware of a much reduced sensat
33. equency of the sound 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 8 Combination 855 surface of the treatment area to keep the ultrasound transducer moving and to use a good coupling medium t
34. ery 2 seconds PSU only units will indicate that there is no battery fitted PSU battery units will show the estimated battery capacity and whether the battery is being charged Stand by Stand by Battery Batter J24 Hot Installed Char3ing was oto start oto start PSU only unit PSU battery unit If the unit is left in stand by mode for longer than 5 minutes then the LCD will be turned off to save power but the power indicator will continue to flash If there is a battery installed the unit will continue to monitor and if necessary charge the battery The LCD can be restored by pressing any key or moving the rotary control To turn on the unit press the power key Battery Operation For battery operation PSU battery units only press the power key and hold it down until the EMS logo appears on the LCD The power key should then be released Combination 855 35 Power on sequence and general information When the Combination 855 is turned on the EMS company logo is displayed on the LCD followed by the model The unit will then give a short beep and display the information screen showing the model number and software version EMS Fhusio Ltd Model 118 Firmware Wersion 1 65 1 66 1 61 menu for set ur COMBINATION S55 Logo and model Information screen After approximately 3 seconds the unit will give another short beep and display the main system menu screen Combination Proatacals Power
35. f 4 RB480 50 x 100 mm oval pack of 4 RB490 80 x 130 mm oval pack of 2 Supplied with each unit is a detachable mains lead suitable 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 28 Combination 855 Controls and Markings Combination 855 front Panel IEC Symbol 348 Attention consult accompanying documents IEC Symbol 878 01 37 Output Stimulator IEC Symbol Ultrasound Output 878 02 03 Output Type BF Equipment The infrared window is for the IrDA interface used for service and calibration purposes Combination 855 29 Combination 855 Rear Panel Model number and classification Name and address of manufacturer Ultrasound symbol according to Health and Welfare Canada safety code 23 PULSE DURATION ame mM 0120 nS CE mark showing conformity to 93 42 EEC Description of ultrasound output waveform for each mode COMBINATION 855 CLAS TYI OPTIONAL INTERNALLY POWERED OUTPUT PULSED CONTINUOUS oe EMS Physio Ltd Oxfordshire England www emsphysio co uk MTE WHEN BATT FITTED O MODEL 118 PE BF IPX1 ULTRASOUND INTERFERENTIAL CAUTION ATT
36. fectants 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 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 The Combination 855 has the option of an internal NiMh rechargeable battery Whenever the unit is connected to the 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 must only be replaced by authorised service personnel Do not mutilate puncture or dispose of batteries in fire 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 request Combination 855 65 EMC Tables Guidance and manufacturers declaration electromagnetic emissions The Solo Combination 855 is intended for use in the electromagnetic environment specified below The customer or the user of the 855 should assure that i
37. he patient lead becomes redundant it is advisable to disconnect it during combination therapy If 2 pole interferential is chosen the most commonly used setting for combination therapy the A2 terminal outside yellow wire becomes the other electrode and the B2 and A1 wires become redundant and should be disconnected If 4 pole interferential is chosen for combination therapy the B2 terminal inside blue wire becomes the electrode paired with the Ultrasound head and the yellow wires A1 and A2 become an independent pair of electrodes on stimulation channel A Set up both the ultrasound and the stimulator screens ready for treatment pressing the menu key after each set up to return to the system menu When both modalities have been programmed highlight Combination using the up down keys and press the menu key again Combination 855 55 The following combination page will appear IE SA e cpyz This displays the current ultrasound and A LAG stimulation settings in abbreviated cs gwm dp form 4kHz 154 TOA ae ae Poe Note that the treatment time defaults to the last figure entered if two different times were set for ultrasound and stimulation this can be altered by highlighting the clock in this page Only treatment time and stimulation intensity can be controlled in the combination page Apply coupling medium to the treatment site and position the ultrasound transducer on the patient so that the lesion point is
38. ion 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 14 Combination 855 Contraindications Electrotherapy Acute Sepsis due to the risk of spreading infection 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 unless specialist medical opinion has first been obtained Fe
39. ion effect which can be restored by restarting the ultrasound In addition the simultaneous application of ultrasound with electrotherapy minimises the accommodation phenomenon normally associated with electrical stimulation of the peripheral nerves The combination of ultrasound with interferential therapy appears to give rise to less adverse treatment effects than are associated with the combination of ultrasound with diadynamic currents or other electrical stimulations It has also been suggested that a greater effective treatment depth can be achieved with an ultrasound interferential combination Unlike routine interferential therapy the intensity of the electrical stimulation in combination therapy may need to be REDUCED during treatment probably due to the continued effect of the ultrasound on the nerve membrane threshold In summary by combining the two treatment modalities none of the individual effects of the treatment are lost but the benefit is that lower treatment intensities can be used to achieve the same results and there are additional benefits in terms of diagnosis and treatment times 12 Combination 855 Precautions The therapist must be aware of the following precautions and potential hazards Simultaneous connection of a patient to high frequency surgical equipment may result in burns at the site of the stimulator electrodes and possible damage to the stimulator itself Operation in close proximity less than
40. le 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 800M 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 Combination 855 69 Essential Performance Power Input Treatment Timer Ultrasound Frequency Maximum Intensity Maximum Output Power Output Modes Pulse Duration Large Transducer Small Transducer Interferential 4 pole 100 240V ac 0 to 30 minutes 1 1 MHz 5 and 3 4 MHz 5 1 5 W cm 20 in CW 3 0 W cm 20 pulsed modes 6 W 420 average CW and pulsed 1 1 1 2 1 4 and 1 9 2 ms 410 ERA 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 Carrier Frequency 2 kHz 4 kHz or 8 kHz 5 AMF 0 250 Hz in 1 Hz increments 42 Swing Pattern 111 616 or 6 6 Output type CC 0 100mA peak 410 into 500 ohms Output Channels Interferential 2 pole CV 0 70V peak 10 into 2 kohms 2 Carrier Frequency 2 kHz 4 kHz or 8 kHz 4 5 AMF 0 250 Hz in 1 Hz increments 2 Swing Pattern 111 616 or 6 6 Output type CC 0 100mA peak 410 into 500 ohms CV 0 140V peak 1 channel 10 into 2 kohms C
41. ll flash and the treatment time will begin to count down Advance the output control slowly until the desired effect of the stimulation is produced Always advance the output control slowly During the last 5 seconds of any treatment the output is smoothly reduced to zero In some operating modes additional information is displayed when the output of the stimulator is on In 4 pole and 2 pole interferential mode the instantaneous frequency AMF is displayed AMF i Poner In russian mode a diagrammatic representation of the output waveform is displayed with a progress bar beneath it The set up information is summarised on the left side of the LCD The progress bar serves to let the patient and operator know when a surge is expected and in progress i Power Combination 855 53 Similarly in sinusoidal and faradic modes a diagram shows the amplitude of the surge envelope and a progress bar shows the current position in the surge cycle Power In interrupted galvanic mode a similar diagram shows the pulse period and the progress bar shows rar SAAME the patient and user when the next BAM ih pulse is about to arrive Power x When a constant current output is chosen and the unit is operating in 4 or 2 pole interferential russian diadynamic sinusoidal galvanic or trabert modes the electrode impedance is monitored to ensure that adequate electrode contact is maintained If the unit detects a
42. lockwise sets the contact monitor to audible and turning it anticlockwise sets the monitor to standard no audible alarm To exit set up press the menu key 60 Combination 855 Protocols and Ultrasound Dose Algorithm Software Optional Accessory am Merny The Protocols are accessed from the main System Menu screen by scrolling down using the UP DOWN Combination keys and then pressing menu Protocols R Power Highlighting and then selecting Protocols by pressing the menu key will bring up this selection screen This gives you the choice of Ultrasound Protocols Interferential Protocols the Ultrasound Dose errerentia Algorithm or return to the System UWS algorithm AC0 le Sustem Merny Menu screen These are selected by highlighting with the UP DOWN keys EPOE x and then pressing menu If the unit does not have the optional Protocols and Dose Algorithm installed selecting the Protocols tab in the System Menu screen will produce this message Frotocals Ft ian not installed menu to continue Power Combination 855 61 Ultrasound Protocols Highlighting Ultrasound Protocols in the selection menu window and pressing the menu button will bring up the ultrasound protocol selection screen The various different aE Power s treatment protocols can be selected by turning the rotary dial use the UP DOWN keys to access the Quit option Pressing the menu key will load the treatme
43. m soapy water to minimise skin impedance and remove any creams or gels that may have been used Explain to the patient what is being done and what is going to happen Soak the sponge electrode covers in warm water In a soft water area it may be necessary to add a small amount of bicarbonate of soda to the water to ensure low contact impedance for the electrodes Fit the rubber electrodes fully into the sponge covers Apply the electrodes to the patient using the elasticated bandages supplied The bandages must cover the whole of the electrode and maintain an even pressure in order to achieve a uniform current flow A piece of polythene may be used between the top surface of the sponge cover and the elasticated bandage to prevent the bandage becoming wet Connect the electrodes to the stimulator output with the cables provided For DC applications the yellow lead is positive and the blue negative It is important to ensure that the patient feels the expected sensation in the required area during treatment otherwise the electrodes should be relocated The electrodes must never be placed so that the stimulating current crosses the chest or passes near the heart Combination 855 57 Re useable electrodes should be cleaned and disinfected between patients A full range of self adhesive electrodes is also available see technical specification section System menu Pressing the menu key from any set up screen takes the user to th
44. n electrode impedance too high to safely deliver the required current then the output of the Combination 855 is terminated an error message is displayed on the bottom line of the LCD and an intermittent alarm is sounded To cancel the alarm and clear the error message press any key on the keypad or turn the rotary control anticlockwise The remaining treatment time is maintained Check the electrodes and leads before continuing treatment If rubber pad electrodes and sponge covers are being used then check that they are held securely with even pressure by the elasticated bandages and that the sponges have not dried out 54 Combination 855 Note In soft water areas it may be necessary to add a small amount of bicarbonate of soda to the water used to wet the sponges in order to achieve adequate contact When the treatment time reaches zero a three second alarm is sounded From any of the set up screens pressing the menu key when the output is off returns to the system menu Combination Therapy It is recommended that only the large Ultrasound transducer is used for combination therapy in order to maintain sufficient contact area to keep the stimulator current density to a safe level The surface of the Ultrasound transducer is internally connected to the B1 terminal of the stimulator patient lead outside blue wire and thus becomes that electrode when used in Combination mode As the blue wire coming from the B1 terminal on t
45. nt settings for the selected protocol Note that the maximum available 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 except for output intensity It is also possible to store an edited version of a protocol as a user program by pressing the menu key selecting User Programs and then selecting the program number and the Save option Upon re loading these settings from a user program it will be found that the maximum intensity is no longer preset Interferential Protocols Highlighting Interferential Protocols in the selection menu screen and pressing menu will bring up the Interferential Protocol selection screen TT Protocols The various different treatment RS Sees protocols can be selected by turning Dedema the rotary dial use the UP DOWN keys to access the Quit option Pressing the menu key will load the treatment settings for the selected protocol Power Before commencing treatment by incrementing the output intensity it is possible to edit the settings if required It is also possible to store an edited version of a protocol as a user program by pressing the menu key selecting User Programs then selecting the program number and then the Save option 62 Combination 855 Dose Algorithm for Ultrasound only From the Protocols selection screen scrolling
46. o avoid unwanted reflections and locally high intensities Electrotherapy Low frequency stimulation Diadynamic currents were introduced by Dr Pierre Bernard They are various combinations of half and full wave rectified 50 Hz sinewaves Their therapeutic benefits include pain relief reduction of swelling and inflammation increased local circulation muscle strengthening and re education The Combination 855 produces DF diphas fixe MF monophas fixe CP courtes p riodes CPiso courtes p riodes isodynamique LP longues p riodes and RS thythme syncope waveforms Surged 50 Hz sinusoidal currents may be used to produce rhythmical muscle contraction This can help in the reduction of oedema and produce an increase in circulation in the treated area Faradic pulses are of short duration less than 1 ms and have a repetition rate of 50 Hz They are normally surged to produce rhythmical muscle contraction Galvanic or direct current is used for pain relief and iontophoresis The Combination 855 produces a wide range of interrupted galvanic pulses Rectangular pulses from 10us to 1s are available and other shapes from ms to 1s Trabert s current sometimes known as ultra reiz has a fixed pulse width of 2 ms and a period of 7 ms and is used for pain relief The Medi Wave signal is a bipolar exponential decaying wave which emulates the H waveform found in nerve signals Hoffman Reflex At low repetition frequencie
47. on burst and surged modes are also available Channels 1 or 2 output channels are available When the channels label is highlighted turning the rotary control clockwise selects 2 channel operation and anticlockwise selects single channel operation Note that in 2 channel operation all settings for the two channels are the same including the output level CC CV The output may be set to be constant current CC or constant voltage CV Combination 855 51 Treatment Connect the patient lead to the output socket of the unit Attach suitable electrodes to the patient and connect the patient lead to the electrode using the blue and yellow cables provided For 2 channel treatments the yellow cables are channel A and the blue cables channel B For single channel treatment use the outside yellow and blue cables 2 channel Single channel treatment treatment For stimulation modes that have a dc component the yellow lead is positive and the blue lead negative 52 Combination 855 Check that all the unit settings are as required for the chosen type of stimulation Using the up and down keys highlight the output symbol on the LCD Slowly turn the rotary control clockwise to increase the output level If the treatment time is zero the unit will give a short alarm to indicate that the output cannot be energised Power If the treatment time is not zero the output of the stimulator will be energised the output symbol wi
48. r screen to appear Stimulator Power Scrolling down past the TENS setting reveals further stimulation options Stimulator Diadynamic Sinusoidal Faradic Power And more Stimulator Int Galy Trabert Medi hlave Power Pressing the menu button now would return the screen to the main system menu Combination 855 41 The following describes the set up pages for each stimulation type when accessed by highlighting it in the Stimulator menu and pressing the menu key 4 pole Interferential Set up When the 4 pole interferential set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown IT 4p interferential therapy 4 pole Treatment Time With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals Power MF Medium Frequency Carrier With the MF label highlighted turn the rotary control clockwise to increase the carrier frequency and anticlockwise to decrease the carrier frequency Base and Peak frequencies The Amplitude Modulation Frequency AMP or beat frequency is set as a Base and Peak beat frequency The beat frequency sweeps between the base and the peak frequency at a rate determined by the set Pattern Patt If the base and peak frequencies are set to the same value then a constant beat frequency
49. r a sinewave the peak output or amplitude is equal to the rms output multiplied by 2 or conversely rms output peak output x 0 707 24 Combination 855 Peak Voltage Time Three standard surge patterns are provided The rest rise hold and fall times for each pattern as a percentage of the complete surge cycle are shown below Pattern Rest Rise Hold Fall Rectangular 50 5 40 5 Triangular 50 33 16 1 Trapezoidal 50 25 13 12 Faradic The output in faradic mode is a series of 0 5ms pulses at a repetition rate of 50 Hz with a zero dc content The pulse train is surged in the same way as the sinusoidal output Galvanic Galvanic mode produces a direct current from 0 to 70 mA Interrupted Galvanic Interrupted Galvanic mode Rectangular produces three standard pulse shapes All interrupted galvanic pulses are positive going and a T Triangular monophasic and have therefore a net dc component pain TEN Trapezoidal 3 Rectangular pulses are available lse Width p from 10 ps to 1 s pulse width and triangular and trapezoidal pulses from 1 ms to 1s The pulse repetition rate is from 1 to 30 pulses per minute Combination 855 25 Trabert This mode produces a continuous train of 2ms pulses with a 5 ms interval between each pulse The pulse repetition rate is therefore approximately 143 Hz Medi Wave The Medi Wave output is a train of differentiated pulses with a pulse width of 6 ms
50. rier Frequency Period Frequency Period 2 kHz 2 kHz 500 us 1 75 2 kHz 572 500 us 4 kHz 4 kHz 250 us 3 75 4 kHz 267 250 us 8 kHz 8 kHz 125 us 7 15 8 kHz 129 125 us In constant current mode the maximum output current per channel is 100 mA peak 70 mA rms The maximum load impedance in ohms at any given output current is given by Maximum impedance 70000 peak output current in mA In constant voltage mode the maximum output voltage is 70Vpeak or load impedance x 0 1 Vpeak whichever is the smaller 20 Combination 855 Interferential 2 pole gt lt cycle of carrier 2 4 or amp kHz A A f i hh T e j Ei RE j 1 cycle of AMF 1 250 Hz The maximum output voltage and current are the same as for 4 pole interferential operation Russian Stimulation 1 cycle of carrier frequency 2 5 kHz VW a 1 cycle of burst frequency gt On Time Off Time The burst frequency may be set to be from Hz to 100 Hz The on and off times are always equal and are from 0 5s 1 Hz burst to 5 ms 100 Hz burst The maximum output voltage and current are the same as for 4 pole interferential operation Combination 855 21 TENS Three TENS waveforms are available Asymmetrical Waveform Symmetrical Waveform eee Sequential Waveform as gt i Pulse Width 20 400 us I i hs Pulse Period p
51. s 2 Hz Medi Wave offers profound muscle stimulation and at higher frequencies 60 Hz deep analgesic pain control Combination 855 9 Medium frequency stimulation Interferential therapy employs medium frequency currents used in 2 or 4 pole configurations to produce a low frequency stimulation effect Prior to the introduction of interferential therapy in the mid 1950s low frequency stimulation was used for pain relief muscle re education etc These currents however have the disadvantage that normal human skin has a relatively high impedance at such frequencies In order to overcome the skin impedance a larger voltage has to be used to achieve the desired current resulting in a more uncomfortable treatment for the patient In addition the penetration depth of these currents is poor and in part is limited by the discomfort to the patient Interferential therapy overcomes the problem of skin impedance At 50 Hz faradic current the impedance for a 100 cm of skin is approximately 3000 ohms At 4000 Hz medium frequency the skin impedance of the same area is around 50 ohms This means that a much lower voltage signal can be used to produce the desired current resulting in less skin sensation and a more comfortable treatment This medium frequency is however well outside of the normal biological frequency range 0 1 to 250 Hz In order to produce the required stimulation two medium frequencies are used A constant frequency of s
52. self 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 Combination 855 Introduction The Combination 855 provides 1 and 3 MHz ultrasound and a complete range of low and medium frequency waveforms for electrotherapy and electro diagnostics Ultrasound Sound is a 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 produc
53. t is used in such an environment Electromagnetic environment Emissions Test Compliance guidance The 855 uses RF energy only for its RF emissions internal function Therefore its RF CISPR 11 Group 1 emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 classi Harmonic not The 855 is suitable for use in all emissions applicable establishments other than domestic and IEC 6100 3 2 f those directly connected to the public Vol low voltage power supply network that otage supplies buildings used for domestic fluctuations not purposes Flicker emissions applicable j IEC 61000 3 3 Guidance and manufacturers declaration electromagnetic immunity The Solo Combination 855 is intended for use in the electromagnetic environment specified below The customer or the user of the 855 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic Environment guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile discharge If floors are covered with ESD synthetic material the IEC 61000 4 2 Teva 8 KV air relative humidity should be at least 30 2 kV for Electrical fast transient burst power supply lines 2 kV for power supply lines Mains power quality should be that of a
54. tles EMS502A EMS Coupling Medium llitre bottle EMS502B Dispenser Pump for 1 litre bottles SLA3055 Patient Lead 4 way NC3052A 4 small sponge electrode covers for NC3052B NC3052B 4 small 70 x 50 mm conductive rubber electrodes NC3053A 4 medium sponge electrode covers for NC3053B NC3053B 4 medium 100 x 70 mm conductive rubber electrodes NC3054A 4 large sponge electrode covers for NC3054B Combination 855 27 NC3054B 4 large 130 x 100 mm conductive rubber electrodes NC3057 1 pair of blue electrode connection cables NC3058 1 pair of yellow electrode connection cables NC3041 Electrode handle for circular pad amp ball electrodes NC3042A Connecting cable for electrode handle NC3046 Circular pad electrode 12 mm diameter NC3048 Circular pad electrode 37 mm diameter NC311A Ball electrode for muscle testing DUI Stretch Bandage 600 x 75 mm DU2 Stretch Bandage 1200 x 75 mm DU4 Stretch Bandage 600 x 50 mm EMS525 SoLo Shoulder Bag EMS157 SoLo Treatment Trolley A range of single patient self adhesive electrodes is available Catalogue Number Description RB410 33 x 54 mm pack of 4 RB420 50 x 89 mm pack of 4 RB430 50 x 50 mm pack of 4 RB440 80 x 100 mm pack of 2 RB450 25 mm diameter round pack of 4 RB460 50 x 130 mm pack of 2 RB470 40 x 60 mm oval pack o
55. ts graphically on the LCD Combination 855 45 Hz The pulse frequency may be set from 1 to 250 Hz in 1 Hz increments Mod The TENS output may be continuous burst or surged Each modulation type is represented graphically on the LCD MHH Continuous Surged CC CV The output may be set to be constant current CC or constant voltage CV Note that in TENS mode 2 output channels are produced and all settings for the two channels are the same including the output level Diadynamic Set up When the diadynamic set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown DIAD Pe E Polarity Pos 3 CCl CE Power zs Treatment Time With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals Type The diadynamic waveform may be selected using the rotary control when the type label is highlighted The full range of diadynamic waveforms is available DF diaphas fixe MF 46 Combination 855 monophas fixe CP modul en courtes p riodes Cpiso modul en courtes p riodes isodynamique RS rythme syncop and LP modul en longues p riodes Full details of these waveforms are given in the technical specification section of this manual Polarity This reverses the polarity of the waveforms see technical spec It is parti
56. vailable Rect rectangular Tri triangular and Trap trapezoidal A full description of these waveforms is available in the technical specification section of this manual The waveform may be changed using the rotary control when the form label is highlighted Width The pulse width may be set from I ms to 1s for all waveforms with additional narrower pulses for rectangular only Rate Pulse rates of 2 5 10 20 and 30 per minute are available The pulse rate may be changed using the rotary control when the rate label is highlighted CC CV The output may be set to be constant current CC or constant voltage CV Trabert Set up When trabert is selected from the system menu the mode is shown at the top right of the screen TRAB The only available options are treatment time and CC CV which are set in exactly the same way as the other operating modes Power 50 Combination 855 Medi Wave Set up When the medi wave set up screen is first displayed the clock symbol is highlighted At the top right of the screen the current mode is shown MWAVE Treatment Time With the clock symbol highlighted turn the rotary control clockwise to increase the time and anticlockwise to decrease the time The time can be set in 30s intervals Freq The frequency may be set from 1 to 60 Hz in 1Hz increments Power Mod Normally Medi Wave stimulation is used in continuous mode that is with no modulation none In additi
57. will light the output symbol on the LCD will flash and the treatment time will begin to count down Move the transducer over the treatment site in small circular paths whilst setting the output intensity to the required level using the Ultrasound Up Down keys If the transducer is not connected to the output socket or the treatment time is zero then the unit will give a one second beep and the output will not be energised Always keep the face of the 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 output intensity display will flash indicating that the required output cannot be delivered When good contact is restored Combination 855 39 the treatment indicator on the transducer will light the output display will cease to flash and the timer will continue to count down If the output intensity is returned to zero using the keys 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 00
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