User Manual Primo Combination 860
Contents
1. Combination 860 67 Medi Wave The Medi Wave output is a train of differentiated pulses with a pulse width of 6 ms 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 1 cycle of pulse frequency minute Two channels of output are available with independent intensity control Microcurrent The Microcurrent output is a unipolar square wave with a frequency variable between 0 and 1000 Hz It is a small constant current variable between 0 and 1mA and its polarity may be selected as Pos Neg or autorev half way through the treatment time Environmental conditions for transport and storage Temperature 10 to 35 C Relative Humidity 5 to 95 Atmospheric Pressure 500 to 1060 hPa 68 Combination 860 Output display The Primo Combination 860 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 Primo Combination 860 has been designed to meet the requirements of BS EN 60601 1 2006 Medical Electrical Equipment Part 1 General requirements for safety BS EN 601 2 5 2001 Medical Electrical Equipment Part 2 5 Particular requirement2. And more Stimulation Pressing the menu button now would return the screen to the main system menu Combination 860 27 The following describes the set up pages for each stimulation type when accessed by pressing the relevant button in the stimulation screen 4 pole interferential set up Interferential 4 pole Treatment time Is selected either by touching the digits of the time display or by pressing the clock symbol and entering the desired treatment time The time can be set in 30s intervals Carrier Pressing this button selects 4 8 or 2 kHz carrier frequency AMF Pressing this button opens the AMF window Interferential 4 pole eo MFCHz gt e 040 210 Lox The amplitude modulation frequency AMF 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 setting of the Pattern button If the base and peak frequencies are set to the same value then a constant beat frequency is produced The Base and Peak frequencies may be set in 1 Hz increments from 0 to 250 Hz Press OK when the desired frequencies have been chosen to return to the 4 pole Interferential set up screen 28 Combination 860 Pattern The pattern determines the rate at which the beat frequency sweeps between the base and peak frequencies Three patterns are available by pressing the Pattern button The 1 1 pattern gives 1 sec
3. Combination 860 53 Combination therapy In general terms combination therapy involves the simultaneous application of ultrasound with an electrical stimulation therapy The main advantages of such a combination are said to be in localising lesions especially chronic ie diagnostic use ensuring accurate localisation of ultrasound treatment to provide increased accuracy effectiveness in treating deeper lesions treating trigger points Possible explanations of effects 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 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 v
4. Consult instructions for use documents Ultrasound output IEC symbol Stimulator 878 01 37 output Output IEC symbol 878 02 03 Type BF equipment Combination 860 13 Primo Combination 860 underside Serial IEC symbol 348 sania d Attention consult date of accompanying IEC symbol 7000 1641 documents manufacture consult instructions for use Name and Do not dispose address of of as unsorted manufacturer waste 2006 96 EC WEEE Directive Model number and classification UATE Description of ultrasound output waveform for each mode Stimulation j output levels Combination 860 Primo Combination 860 top On Off button LCD touch panel IEC symbol 848 01 26 variability in steps Primo Output control knob i Cradle for ultrasound transducer Combination 860 15 PMA9125 1 1 3 4 MHz SN ce ce 0120 For use with EMS Physio Primo range only Beam type collimated Rated output 6W BNR 5 0MAX ERA 4cm EN61689 Large transducer Treatment light Active face PMA 9135 1 1 3 4 MHz SN a ce as For use with EMS Physio Primo range only Beam divergent collimated Rated output 0 9W 0 6W BNR 5 0MAX ERA 0 6cm 0 4cm EN61689 Small transducer Treatment light Active face The ultrasound transducers are calibrated independently from the Primo Combination 860 and are
5. If the unit is used for combination therapy or with internal electrodes vaginal or anal then constant voltage is recommended Protocols The Prot button 4 pole interferential mode only gives access to a range of pre set parameter settings aimed at treating various listed conditions these are explained in more detail later in this manual Combination 860 29 2 pole interferential set up Interferential 2 pole Carrier AMFCHz gt 4kHz 168 108 Pattern Vector 6 6 Off 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 The 2 pole interferential set up is similar to the 4 pole set up The treatment time carrier frequency base and peak frequencies pattern and CC CV operation are set up in exactly the same way 30 Combination 860 Russian set up oe BHR fed 20 00 Treatment time Is selected in the same way as previously Burst The burst frequency may be set from 1 Hz to 100Hz by pressing the Burst button 0 10 Hz is in 1 Hz steps 10 50 Hz in 5 Hz steps and 50 100 Hz in 10 Hz steps 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 example if the ratio is set t
6. 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 It is intended that the Combination 860 unit is only used by qualified healthcare professionals such as physiotherapists who have received training in electrotherapy 6 Combination 860 Introduction The Primo Combination 860 provides 1 and 3 MHz ultrasound and a complete range of low and medium frequency waveforms for electrotherapy Both modalities may be used individually or in combination Indications for use Therapeutic ultrasound may be 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 Ultrasound may also be used for phonophoresis the movement of drugs through the skin under the influence of ultrasound Some drugs are absorbed through the skin very slowly and ultrasound may be used to accelerate the process The Primo Combination 860 unit also provides 4 pole and 2 pole interferential therapy as well as a wide range of other electrical stimulation waveforms Therapeutic voltage and current waveforms may be applied to a wide range of conditions with successful outcomes These include acute and subacute traumatic and inflammatory conditions
7. 2 2 ms on 5ms off rectangular CC 0 70mA peak CV 0 140V peak Positive negative or auto reverse 2 Combination 860 59 Medi Wave Waveform Frequency Modulation Output type Output channels Microcurrent Waveform Frequency Output type Polarity Output channels 60 6 ms differentiated pulse 2 60 Hz None burst surged CC 0 50mA peak CV 0 60V peak 2 Square wave 50 duty cycle 1 1000Hz CC 0 1mA Positive negative or auto reverse 2 Combination 860 Output waveforms Interferential 4 pole t 1 cycle Channel A tA cycle Channel B Channel A Channel B Carrier 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 75 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 V peak whichever is the smaller Combination 860 61 Interferential 2 pole gt lt cycle of carrier 4 oe KHz A A As E A y E Vy yy y 4 cycle of AMF 1 250 Hz The maximum output voltage and current are the same as for 4 pole interferential operation Two channels of o
8. displayed on the LCD along with the company web address the model name and the installed firmware version D EMS Physio Ltd www eMsphusio co uk Combination F608 Firmware Versio 1 02 1 02 The unit will then give a short beep and display the System Menu screen EF ESS a LLLI Ultrasound Stimulation Combination At the bottom of the screen is the status bar The status bar shows the current power source and the battery status if installed If the unit is fitted with a rechargeable battery pack the battery symbol Gr will be shown in the status line The symbol is shaded to show the current charge state of the battery Gr 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 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 Combination 860 19 Standard user controls Throughout the operation of the Combination 860 the various modes and parameter settings are all accessed and changed by pressing the relevant display on the LCD touchscreen The rotary control is used to increase and decrease the ultrasound intensity when the LCD is showing the ultrasound screen or it controls the stimulation intensity when a stimulation
9. fully interchangeable 16 Combination 860 Patient lead PMA3055 Electrode connecting cables a Combination 860 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 within two working days the carrier and the Company or its agent from whom the unit was purchased The Primo Combination 860 must only be used with an EMS Physio 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 Primo Combination 860 unit is supplied with a large 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 an arrow and the word top embossed on it to aid correct orientation 18 Combination 860 Operating instructions Power on sequence and general information When the Primo Combination 860 is turned on the EMS company logo is
10. in 1 Hz increments 10 CC 0 100mA peak 10 into 500 Q CV 0 60V peak 10 into 2 k Q DF MF CP CPiso RS LP CC 0 70mA peak 10 into 500 Q CV 0 140V peak 10 into 2 k Q 50 Hz 5 2 to 30 minute 10 Rectangular triangular or trapezoidal CC 0 50mA peak 10 into 500 Q CV 0 100V peak 10 into 2 k Q 50 Hz 5 2 to 30 minute 10 Rectangular triangular or trapezoidal CC 0 50mA peak 10 into 500 Q CV 0 100V peak 10 into 2 k Q CC 0 70mA peak 10 into 500 Q CV 0 140V peak 10 into 2 k Q 10 us to 1 s 5 for rectangular in 1 2 1msto1s 5 for other shapes Rectangular triangular or trapezoidal 1 to 30 minute 10 CC 0 70mA peak 10 into 500 Q CV 0 140V peak 10 into 2k Q Combination 860 75 Trabert Waveform rectangular Output type Medi Wave Waveform Frequency Output type Microcurrent Waveform Frequency Output type Polarity 76 2 ms on 5 5ms off 5 CC 0 70mA peak 10 into 500 Q CV 0 140V peak 10 into 2k Q 6 ms 5 differentiated pulse 2 60 Hz 5 CC 0 50mA peak 10 into 500 Q CV 0 60V peak 10 into 2 k Q Square wave 50 duty cycle 1 1000Hz CC 0 1mA 20 Positive negative or auto reverse Combination 860 Combination 860 77 EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE UK T 01235 772272 F 01235 763518 E sales emsphysio co uk Website htt
11. 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 a series of compressions and rarefactions are produced in the direction of travel of the wave Therefore sound waves are longitudinal waves Longitudinal Wave Compression Rarefaction Compression Rarefaction Compression 7 ie 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 sine wave 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 50 Combination 860 Sound will travel faster through media where the molecules are closer together and so the velocity is higher in solids than in liqu
12. may be set to be constant current CC or constant voltage CV by pressing the CC CV button Combination 860 33 Diadynamic set up Diadunamic a P g 19 Treatment time is set as already described Type The diadynamic waveform may be selected by pressing the Type button The full range of diadynamic waveforms is available DF diaphas fixe MF 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 particularly 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 If the Autorev option is selected the polarity of the output will automatically reverse half way through the selected treatment time CC CV The output may be set to be constant current CC or constant voltage CV by pressing the CC CV button 34 Combination 860 Sinusoidal set up Sinusoidal Treatment time is adjusted as explained above 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 se
13. 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 say 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 860 provides two channels of asymmetric symmetric or sequential output with a wide range of pulse widths and repetition rates
14. pain relief and iontophoresis The Combination 860 produces a wide range of interrupted galvanic pulses Rectangular pulses from 10us to 1s are available and other shapes from 1 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 frequencies 2 Hz Medi Wave offers profound muscle stimulation and at higher frequencies 60 Hz deep analgesic pain control 52 Combination 860 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
15. Carrier frequency AMF Swing pattern Output type Interferential 2 pole Carrier frequency AMF Swing pattern Output type Russian Stimulation Carrier frequency Modulation frequency Surges Output type 74 100 240V ac 0 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 20 IEC61689 collimated BNR lt 5 ERA 0 6cm 20 IEC61689 divergent at 1MHz ERA 0 4cm 20 IEC61689 collimated at 3MHz BNR lt 5 2 kHz 4 kHz or 8 kHz 5 0 250 Hz in 1 Hz increments 42 1 1 6 6 or 6 6 CC 0 100mA peak 10 into 500 Q CV 0 70V peak 10 into 2 k Q 2 kHz 4 kHz or 8 kHz 5 0 250 Hz in 1 Hz increments 2 1 1 6 6 or 6 6 CC 0 100mA peak 10 into 500 Q CV 0 70V peak 10 into 2 k Q 2 5 kHz 5 1 100 Hz 5 1 1 to 1 5 CC 0 100mA peak 10 into 500 Q CV 0 70V peak 10 into 2k Q Combination 860 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 5 sequence Waveform Pulse rate Output type Asymmetrical symmetrical or sequential 20 400 us in 5 us increments 10 1 250 Hz
16. Mains power quality should be that of a typical commercial or hospital environment If the user of the 860 requires continued operation during power mains interruptions it is recommended that the 860 be powered from an uninterruptible power supply or a battery Power frequency magnetic field should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level Combination 860 71 Guidance and manufacturers declaration electromagnetic immunity The primo Combination 860 is intended for use in the electromagnetic environment specified below The customer or user of the Primo Combination 860 should ensure that it is used in such an environment IEC 60601 Compliance Electromagnetic environment Immunity test test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the Primo Combination 860 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 Vi IEC61000 4 6 150kHz to 80MHz Radiated RF 3V m 3V m d 3 5VP E1 80MHz to 800MHz IEC61000 4 3 80MHz to d 7VP E1 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 dist
17. User Manual PRIMO COMBINATION 860 Model 125 CE 0120 Combination 860 Contents Contents General information amp record of amendments Declaration of conformity to 93 42 EEC Warranty statement Introduction amp indications for use Contraindications Accessories Controls and markings Installation Operating instructions Ultrasound Stimulation Combination Protocols Ultrasound dose algorithm Maintenance Appendix A Overview of treatment modalities Appendix B Technical specification Appendix C EMC tables Appendix D Essential performance Combination 860 Page 21 27 44 46 47 49 50 56 70 74 General information This manual provides the necessary information for the installation and operation of the Primo Combination 860 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 Record of amendments ISSUE COMMENTS DATE 1 Initial issue 31 03 11 2 Errata corrected 07 04 11 3 Combination therapy instructions 30 06 11 corrected 4 Indications for use added 21 06 12 5 Updated to show latest images 08 10 12 6 Declaration of conformity revised 26 06 14 4 Combination 860 EC Declaration of Conformity Product Name Primo Combination 860 Model Nu
18. ance 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 l 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 a 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 Combination 860 is used exceeds the applicable RF compliance level above the Primo Combination 860 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 Combination 860 gt Over the frequency range 10kHz to 80Mhz field strengths should be less than 3 V m 72 Combination 860 Recommended separation distances between portable and mobile RF communications equipment and the Solo 860 The Primo Combination 860 is intended
19. atological 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 10 Combination 860 Accessories supplied as standard Catalogue Description number SLA9000 DC power supply 18V 60W PMA9125 Large dual frequency transducer EMS502C EMS Physio coupling medium 250ml bottle PMA3055 Patient lead 4 way yellow and blue connecting cables included NC3053A 4 medium sponge electrode covers for NC3053B NC3053B 4 medium 100 x 70 mm conductive rubber electrodes DU2 2 stretch bandages 1200 x 75 mm Optional accessories EMS530 Primo shoulder bag EMS158 Primo trolley PMA9135 Small dual frequency transducer EMS502 EMS Physio coupling medium 8 x 250ml bottles EMS502A EMS Physio coupling medium litre bottle NC3052A 4 small sponge electrode covers for NC3052B NC3052B 4 small 70 x 50 mm conductive rubber ele
20. chronic rheumatoid and arthritic conditions and for pain relief Combination therapy involves the simultaneous application of ultrasound with an electrical stimulation therapy By combining ultrasound with interferential therapy the advantages and effects of each treatment modality can be realised but lower intensities are used to achieve the effect The accommodation effects that normally accompany interferential therapy are reduced or even eliminated The main advantages of such a combination are in localising lesions especially chronic in ensuring accurate localisation of ultrasound treatment to provide increased accuracy effectiveness in treating deeper lesions and in treating trigger points Galvanic output may also be used for iontophoresis the movement of drugs through the skin under the influence of a steady electrical voltage Some drugs are absorbed through the skin very slowly and iontophoresis may be used to accelerate the process Combination 860 7 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 1 metre to shortwave or microwave therapy equipment may produce instability in the stimulator output Consideration must be given to the current densi
21. ction of this manual The surge pattern may be changed by pressing the surge button Rate Surge rates of 2 5 10 20 and 30 per minute are available The surge rate may be changed by pressing the Rate button When running the surge status is shown in the top right corner of the display Sinusoidal s O m TREATMENT CC CV The output may be set to be constant current CC or constant voltage CV by pressing the CC CV button Combination 860 35 Faradic set up Treatment time is set as described above 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 by pressing the Surge button Rate Surge rates of 2 5 10 20 and 30 per minute are available The surge rate may be changed by pressing the Rate button When running the surge status is shown in the top right corner of the display Faradic 7 A TREATMENT CC CV The output may be set to be constant current CC or constant voltage CV by pressing the CC CV button 36 Combination 860 Galvanic set up Galvanic A ima E E BmA cc 19 57 Polarity Pos t Treatment time is set as described above Polarity Pressing this button changes the electrical polarity of the galvanic current Pos Neg or Autorev half way through the
22. ctrodes NC3054A 4 large sponge electrode covers for NC3054B NC3054B 4 large 130 x 100 mm conductive rubber electrodes 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 DU1 Stretch bandage 600 x 75 mm DU4 Stretch bandage 600 x 50 mm Combination 860 11 A range of single patient self adhesive electrodes is available Catalogue Description Number RB410 33 x 54 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 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 Description Number 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 EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE England T 01235 772272 F 01235 763518 E sales emsphysio co uk Website http www emsphysio co uk 12 Combination 860 Controls and markings Primo Combination 860 front panel IEC symbol 348 Attention consult IEC symbol 7000 1641 accompanying
23. diotherapy 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 Similarly extreme care should be taken near the ears and reproductive organs Combination 860 9 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 Febrile conditions Large open wounds in treatment area Derm
24. 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 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 860 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 860 49 Appendix A Overview of treatment modalities 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
25. elow The customer or the user of the Primo 860 should ensure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC61000 4 4 Surge IEC61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz Magnetic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT For 0 5 cycle 40 UT 60 dip in UT For 5 cycles 70 UT 30 dip in UT For 25 cycles lt 5 UT gt 95 dip in UT For 5 sec 3 A m Compliance level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT For 0 5 cycle 40 UT 60 dip in UT For 5 cycles 70 UT 30 dip in UT For 25 cycles lt 5 UT gt 95 dip in UT For 5 sec 3 A m Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment
26. ery Treatment programs 10 user defined set ups Dose algorithm provided Ultrasound Frequency 1 1 MHz 5 and 3 4 MHz 5 Maximum intensity 1 5 W cm in CW 3 0 W cm in pulsed modes Maximum output power 6 W average PSU operation only Output modes CW and pulsed 1 1 1 2 1 4 and 1 9 Pulse duration 2ms Treatment timer 0 to 30 minutes treatment linked Contact monitor Light on transducer Large ultrasound transducer ERA 4cm IEC 61689 5cm 21 CFR 1050 10 BNR lt 5 Beam type Collimated Small ultrasound transducer 1MHz 3MHz ERA 0 6 cm 0 4 cm BNR lt 5 lt 5 Beam Type Divergent Collimated Transducers for use with the Primo Combination 860 Primo Therasonic 360 and 460 are fully interchangeable and suitable for underwater treatment IPx7 rated 56 Combination 860 Pube Wof Of Tire see tab Pulse Off Duty Temporal peak Mode Frequency Time Cycle to average ratio 1 1 250 Hz 2ms 50 2 1 1 2 166 Hz 4ms 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 2 kHz 4 kHz or 8 kHz AMF 0 250 Hz in 1 Hz increments Swing pattern 1 1 6 6 or 6 6 Vector 10s 20 both channels Output type CC 0 100mA peak CV 0 70V peak Output channels 2 Interferential 2 pole Carrier frequency 2 kHz 4 kHz or 8 kHz AMF 0 250 Hz in 1 Hz increments Swing pattern 1 1 6 6 or 6 6 Output type CC 0 100mA peak CV 0 70V peak Output channels 2 C
27. ery soon becomes aware of a much reduced sensation effect which can be restored by restarting the ultrasound 54 Combination 860 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 treatment times Combination 860 55 Appendix B Technical specification General Power input 18V 3 33A external PSU Battery pack optional Internal rechargeable NiMh Classification EN60601 1 Class 1 Type BF Fuse Internal T5A Size h x w x d 108 x 237 x 333 mm Weight 1 3 kg excluding batt
28. for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Primo 860 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Primo 860 as recommended below according to the maximum output power of the communications equipment 150kHz to 80MHz 80MHzto 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 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 Combination 860 73 Appendix D Essential performance The performance characteristics essential to the correct operation of the Primo Combination 860 are Power input Treatment time Ultrasound Frequency Maximum intensity Maximum output power Output modes Pulse duration Large transducer Small transducer Interferential 4 pole
29. gular 50 5 40 5 Triangular 50 33 16 1 Trapezoidal 50 25 13 12 Two channels of output are available with independent intensity control Faradic The output in faradic mode is a series of 0 5ms pulses at a repetition rate of 50 Hz with zero dc content The pulse train is surged in the same way as the sinusoidal output Two channels of output are available with independent intensity control 66 Combination 860 Galvanic Galvanic mode produces a direct current from 0 to 70 mA in either a positive negative or auto reverse half way through the treatment time electrical polarity Two channels of output are available with independent intensity control Interrupted galvanic Interrupted galvanic mode produces three standard pulse shapes Rectangular Triangular ha N Trapezoidai Pulse Width Rectangular pulses are available from 10 us to 1 s pulse width and triangular and trapezoidal pulses from 1 ms to 1s The pulse repetition rate is from 2 to 30 pulses per minute Two channels of output are available with independent intensity control and their polarity may be selected as Pos Neg or autorev half way through the treatment time 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 Two channels of output are available with independent intensity control Pos Neg or autorev polarities are selectable
30. ids 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 decreases exponentially with the distance travelled The attenuation of the beam is also dependent upon the frequency 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 al
31. ired 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 Combination 860 23 System set up menu Touching the Setup button at the bottom of the System Menu screen takes you to the System Set up screen Sustem Set up Contrast Language Contact 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 are installed in the unit 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 24 Combination 860 Ultrasound user programs The Combination 860 can store up to 10 user defined set ups for each modality ultrasound or stimu
32. is 1 second of MF followed by 1 second of zero output this sequence being repeated continually Two channels of output are available with independent intensity control Polarity The above waveforms exhibit Pos polarity as they all travel above the ground zero volts level equivalent to the flat part of the waveforms The polarity switch enables the user to reverse this Neg so that the above waveforms would be rendered upside down both channels are inverted 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 A third option is Auto reverse in which the polarity automatically reverses half way through the selected treatment time Combination 860 65 Sinusoidal In sinusoidal mode the output is an amplitude modulated medium frequency 4 kHz 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 For a sine wave the peak output or amplitude is equal to the rms output multiplied by V2 or conversely rms output peak output x 0 707 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 Rise old ei l l i Peak l l i Voltage i Time Pattern Rest Rise Hold Fall Rectan
33. lation To access the ultrasound user programs press the User button in the top right corner of the ultrasound set up screen User Programs Ultrasound D2 0 00 i i 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 and 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 ultrasound page Combination 860 25 Stimulation user programs Similarly pressing the User button in any of the stimulation set up screens will open the stimulation user program screen User Programs Stimulation IT 4 pole Carrier 4kHz AMF 1 268 Pattern 676 Vector Off These can be saved loaded or erased in much the same way as the ultrasound user programs 26 Combination 860 Stimulator set up From the System Menu screen press the Stimulation button The following stimulation screen will appear Stimulation
34. lation none In addition burst and surged modes are also available 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 CC CV The output may be set to be constant current CC or constant voltage CV Microcurrent set up Microcurrent A BmA E E Bm cc Frequency Polarity LIGHz Pos 3 Freq The frequency may be set from 1Hz to 1000Hz in ascending jumps by repeated presses of this button Polarity This may be Pos Neg or Autorev half way through the selected treatment time 40 Combination 860 Electrode error detection Interferential 4 pole When a constant current output is chosen and the unit is operating in 4 or 2 pole interferential russian diadynamic sinusoidal galvanic or tr bert modes the electrode impedance is monitored to ensure that adequate electrode contact is maintained If the unit detects an electrode impedance too high to safely deliver the required current then the output of the Combination 860 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 button or turn the rotary control anticlockwise The remaining treatment time is maintained Check the electrodes and leads before continui
35. m right hand corner of the screen Interferential 2 pole Carrier AMPFCHz gt 4kHz 188 Pattern Vector 6 6 Off TREATMENT 42 Combination 860 Pressing this causes both outputs to smoothly reduce to zero over a period of 5 seconds Interferential 2 pole Carrier AMPFCHz gt 4kHz 188 Pattern Ue r cto 6 6 Off STOPPING In 4 pole and 2 pole interferential modes the instantaneous frequency AMF is displayed 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 860 43 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 and thus becomes that electrode when used in combination mode As the blue wire coming from the B1 terminal on the patient lead becomes redundant it is advisable to disconnect it during combination therapy The B2 terminal becomes the electrode paired with the ultrasound head and the yellow wires A1 and A2 become an indepe
36. mbers 125 EMS860 EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE United Kingdom Declares that the device listed above is in conformity with the essential requirements and provisions of the following EC Council Directives Directive Conformity assessment route 2011 65 EU Annex II module A 768 2008 EC RoHS 93 42 EEC Annex II of Directive 93 42 EEC under the supervision of Notified Body Number 0120 SGS United Kingdom Ltd Class Ilb according to Annex IX of 93 42 EEC rcs y a M Bowles Signature Position Operations Director Date 26 June 2014 Date first issued 31 March 2011 Combination 860 5 Warranty This EMS Physio Ltd hereinafter called the Company product is warranted against defects in materials and workmanship for a period of two years from the date of shipment The Company will at its option repair or replace components which prove to be defective during the warranty period provided that the repairs or replacements are carried out by the Company or its approved agents The Company will consider itself responsible for the effects on safety reliability and performance of the product only if assembly operations re adjustments modifications or repairs are carried out by persons authorised by it the product is used in accordance with the instructions for use the electrical installation of the relevant room complies with the appropriate national requirements
37. most 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 high intensities Combination 860 51 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 860 produces DF diphas fixe MF monophas fixe CP courtes p riodes CPiso courtes p riodes isodynamique LP longues p riodes and RS rhythme 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
38. n 860 63 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 NNNNA 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 E D 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 the amplitude of the MF signal is 12 5 less than the amplitude of the DF signal 64 Combination 860 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 above RS rythme syncop The RS waveform
39. n the patient so that the lesion point is between the stimulator electrode s and the ultrasound transducer Press and hold the stimulator output button one channel at a time if A and B are available 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 press and hold the US button whilst turning the control knob clockwise The patient may feel a slight increase in 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 Combination 860 45 Protocols Pressing the Prot button in the ultrasound set up screen will call up a list of pre sets tailored for treating various conditions Protocols Ultrasound Pressure Ulcers a 1 of 14 The condition to be treated can be selected using the up down buttons and then pressing select to call up the ultrasound treatment settings for that particular condition There is a similar list of protocols available for stimulation treatment by pressing the Prot button in 4 Pole interferential mode only Protoc
40. ndent pair of electrodes on stimulation channel A If Channel A is not to be used do not turn up its output an electrode error warning will appear if this is done in CC mode 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 press the Combination button The following combination screen will appear Ultrasound 3 MHz 1 93 Interferential 4 pole A BmA E BmA ce kHz 100 1608 6 6 Large transducer This displays the current ultrasound and stimulation settings in abbreviated form If a stimulation setting other than 4 pole interferential was chosen a Combination screen like this will appear Ultrasound E A Huren i a oR 00 rmA BmA cc 1 1 Cont LBBHe 38S Large transducer 44 Combination 860 Note that two independent buttons for Ch A and Ch B now appear at the right of the screen reflecting the fact that independent channel level control is available for all stimulation modes except 4 pole interferential Also 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 o
41. ng treatment If rubber pad electrodes and sponge covers are being used check that they are held securely with even pressure by the elasticated bandages and that the sponges have not dried out Combination 860 41 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 The yellow cables are channel A and the blue cables channel B For stimulation modes that have a dc component the number 1 lead is positive and the number 2 lead negative Check that all the unit settings are as required for the chosen type of stimulation Slowly turn the rotary control clockwise whilst pressing and holding the relevant output channel button right hand side of screen 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 If the treatment time is not zero the output of the stimulator will be energised the output symbol will flash and the treatment time will begin to count down Advance the output control slowly until the desired effect of the stimulation is produced 4 pole interferential does not have independent output channels Always advance the output control slowly During the last 5 seconds of any treatment both outputs are smoothly reduced to zero During any treatment a Stop button appears in the botto
42. o 1 4 then the work period is 10 seconds and the rest period is 40 seconds Press the ratio button to set the ratio to any integer value between 1 1 and 1 5 When running the burst status is displayed in the top right corner of the display CC CV The output may be set to be constant current CC or constant voltage CV by pressing the CC CV button 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 Combination 860 31 TENS set up Treatment time Is set in the same way as described above Three waveform types are available and each type is represented graphically on the LCD Type Symmetrical Asymmetrical 1 Sequential Selection is achieved by pressing the Type button 32 Combination 860 Width pressing this button opens a new window in which the pulse width may be set from 20 to 400 us in 5 us increments by pressing the numerical digits and then pressing OK TENS a idth pe3 100 TENS OO 200 IE a 250 The pulse frequency may be set from 1 to 250 Hz in 1 Hz increments by pressing the numerical digits and then pressing OK Mode control The TENS output may be continuous burst or surged Each modulation type is selected by pressing the Mode button CC CV The output
43. o 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 Re useable electrodes should be cleaned and disinfected between patients A full range of self adhesive electrodes is also available see technical specification section 48 Combination 860 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
44. ols Stimulation Pain relief 1 of 13 46 Combination 860 Ultrasound dose algorithm This is selected by pressing the Dose button in the Ultrasound set up screen If a transducer is not connected this screen will appear prompting to connect one Dose Algorithm Connect transducer When a transducer is connected and Next is pressed this screen will appear Dose Algorithm Lesion Depth 2 0 cm Tissue State Sub acute Treatment Area i cr The data concerning the state of the area to be treated is chosen using the Up Down buttons then pressing Select will cause the algorithm to calculate the relevant treatment settings Combination 860 47 Electrodes It is recommended that only electrodes supplied by EMS Physio Ltd are used with the Combination 860 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 warm soapy water to minimise skin impedance and remove any creams or gels that may have been used Explain t
45. ombination 860 57 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 Output type Polarity Output channels Sinusoidal Frequency AMF Surge rate Surge pattern Output type Output channels 58 2 5 kHz 1 100 Hz 1 1 to 1 5 CC 0 100mA peak CV 0 70V peak 2 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 CC 0 70mA peak CV 0 140V peak Positive negative or auto reverse 2 50 Hz 2 to 30 minute Rectangular triangular or trapezoidal CC 0 70mA peak CV 0 140V peak 2 Combination 860 Faradic Frequency Surge rate Surge pattern Output type Output channels Galvanic Output type Polarity Output channels Interrupted galvanic Pulse width Waveform Pulse rate Output type Polarity Output channels Trabert Waveform Output type Polarity Output channels 50 Hz 2 to 30 minute Rectangular triangular or trapezoidal CC 0 70mA peak CV 0 140V peak 2 CC 0 70mA peak CV 0 140V peak Positive negative or auto reverse 2 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 Positive negative or auto reverse
46. ond at the base frequency followed by 1 second at the peak frequency The 6 6 pattern gives 5 seconds at the base frequency sweeps linearly to the peak frequency in 1 seconds followed by 5 seconds at the peak frequency and finally sweeps back to the base frequency in 1 second The 6 6 pattern sweeps from the base to the peak frequency in 6 seconds and then sweeps back to the base frequency in 6 seconds 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 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 press the Vector button 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
47. p www emsphysio co uk 78 Combination 860
48. s for the safety of ultrasonic physiotherapy equipment BS EN 60601 2 10 1998 Medical Electrical Equipment Part 2 10 Particular requirements for the safety of nerve and muscle stimulators and BS EN 60601 1 6 2007 Medical Electrical Equipment Part 1 6 General requirements for safety Usability Combination 860 69 Appendix C EMC tables 70 1 Guidance and manufacturers declaration electromagnetic emissions The Primo Combination 860 is intended for use in the electromagnetic environment specified below The customer or the user of the Primo 860 should ensure that it is used in such an environment Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 6100 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 Compliance Group 1 Class A not applicable not applicable Electromagnetic environment guidance The 860 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The 860 is 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 Combination 860 Guidance and manufacturers declaration electromagnetic immunity The Primo Combination 860 is intended for use in the electromagnetic environment specified b
49. s 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 and the treatment time will begin to count down If the transducer is not properly 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 Ultrasound Su 1 0 29 4 1 MHz CH A AT J 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 Always keep the face of the transducer in contact with the treatment area and always keep the transducer moving to avoid any standing waves 22 Combination 860 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 An audible alarm will sound if this option has been selected in the Setup menu When good contact is res
50. screen is selected In 4 pole Interferential mode it controls the overall Stimulation intensity in all other stimulation modes it is possible to independently control the levels of channels A and B by pressing and holding the relevant selection button In combination mode three buttons are available except for 4 pole combination therapy when there will be two to select whether the rotary control is assigned to the ultrasound intensity or channel A or B of the stimulator The menu button is used to exit from the current screen or to select the menu option highlighted 20 Combination 860 Ultrasound set up From the System Menu screen press the button marked Ultrasound The Ultrasound set up screen will appear Ultrasound 3 MHz 1 9 L Large transducer Touch the screen on the digits of the time display to increment some treatment time maximum 30 minutes Alternatively touch the clock symbol to bring up the following screen Large transducer Select the desired ultrasound Frequency and Mode pulsed or continuous by touching the relevant field on the screen Combination 860 21 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 Physio Therasonic coupling medium i
51. selected treatment time Combination 860 37 Interrupted galvanic set up Interrupted Galvanic Treatment time is set as described before Form Three different pulse shapes are available Rectangular Triangular and Trapezoidal A full description of these waveforms is available in the technical specification section of this manual Width The pulse width may be set from 1ms 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 Polarity Positive going negative going or auto reverse polarities are available auto reverse occurs half way through the selected treatment time When running the output state is represented by a graphic in the top right corner of the display Interrupted Galvanic 31u Rate 30min Hidth Polarit is Pos i TREATMENT CC CV The output may be set to be constant current CC or constant voltage CV 38 Combination 860 Trabert set up The available options are treatment time polarity and CC CV These are set in exactly the same way as in the other operating modes Medi Wave set up Me di Have Freq pressing this button opens this window Me di Have A BmA OLA AL Frequency HZ 04 J The frequency may be set from 2 to 60 Hz in 1Hz increments Combination 860 39 Mode Normally Medi Wave stimulation is used in continuous mode that is with no modu
52. ties for any electrode used with the Combination 860 unit Current densities greater than 2 mA rms cm are not recommended because of the risk of burning All the standard EMS Physio 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 8 Combination 860 Contraindications ultrasound 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 ra
53. tored 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 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 its cradle on the front 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 requ
54. utput are available with independent intensity control Russian stimulation 1 cycle of carrier frequency 2 5 kHz lt i Wy 1 cycle of burst frequency gt On Time Off Time The burst frequency may be set to be from 1 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 Two channels of output are available with independent intensity control 62 Combination 860 TENS Three TENS waveforms are available Asymmetrical Waveform Symmetrical Waveform Sequential Waveform I I r Pulse Width 20 400 ps I mt i Pulse Period i 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 Two channels of output are available with independent intensity control Combinatio
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