Chiroform PRIMO COMBINATION 860 User Manual
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Chiroform PRIMO COMBINATION 860 User Manual

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User Manual
PRIMO COMBINATION 860
Model 125

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  • Page 1 User Manual PRIMO COMBINATION 860 Model 125...
  • Page 2 Combination 860...

  • Page 3: Table Of Contents

    Contents Page Contents General information & record of amendments Declaration of conformity to 93/42/EEC Warranty statement Introduction & 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 –...

  • Page 4: General Information & Record Of Amendments

    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.

  • Page 5: Declaration Of Conformity To 93/42/Eec

    EC Declaration of Conformity Product Name Primo Combination 860 Model Numbers (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...

  • Page 6: Warranty Statement

    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.

  • Page 7: Introduction & Indications For Use

    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.
  • Page 8 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.

  • Page 9: Contraindications

    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 radiotherapy treatment during the last six months.
  • Page 10 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.

  • Page 11: Accessories

    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...
  • Page 12 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.

  • Page 13: Controls And Markings

    Controls and markings Primo Combination 860 front panel IEC symbol 348 Attention, consult accompanying IEC symbol 7000-1641 Ultrasound documents Consult instructions for use output IEC symbol 878-01-37 Stimulator Output output IEC symbol 878-02-03 Type BF equipment Combination 860...
  • Page 14 Primo Combination 860 underside IEC symbol 348 Serial Attention, consult number and accompanying IEC symbol 7000-1641, date of documents consult instructions for manufacture Name and Do not dispose address of of as unsorted manufacturer waste (2006/96/EC WEEE Directive) Model number...
  • Page 15 Primo Combination 860 top On/Off button LCD touch panel IEC symbol 848- 01-26 variability in steps Output control knob Cradle for ultrasound transducer Combination 860...
  • Page 16 Large transducer Treatment light Active face Small transducer Treatment light Active face The ultrasound transducers are calibrated independently from the Primo Combination 860 and are fully interchangeable. Combination 860...
  • Page 17 Patient lead (PMA3055) Electrode connecting cables FOR USE WITH EMS STIMULATORS Combination 860...

  • Page 18: Installation

    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.

  • Page 19: Operating Instructions

    Operating instructions Power on sequence and general information When the Primo Combination 860 is turned on, the EMS company logo is displayed on the LCD along with the company web address, the model name and the installed firmware version. 1.0?/1.0? 1.0?/1.0?
  • Page 20 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 screen is selected.

  • Page 21: Ultrasound

    Ultrasound set up From the System Menu screen, press the button marked ‘Ultrasound’. The Ultrasound set-up screen will appear. 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:- Type in the desired time and press ENTER to return to the main screen.
  • Page 22 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 is recommended.
  • Page 23 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.
  • Page 24 System set-up menu Touching the Setup button at the bottom of the System Menu screen takes you to the System Set-up screen. The Contrast button takes you to a screen where you can adjust the display contrast using up/down buttons. The Volume button allows for adjustment of the beeper volume (high or low).
  • Page 25 Ultrasound user programs The Combination 860 can store up to 10 user defined set-ups for each modality (ultrasound or stimulation). To access the ultrasound user programs press the User button in the top right corner of the ultrasound set-up screen. The LCD shows the 10 user programs as file cards with numbered tabs.
  • Page 26 Stimulation user programs Similarly, pressing the User button in any of the stimulation set-up screens will open the stimulation user program screen. These can be saved, loaded or erased in much the same way as the ultrasound user programs. Combination 860...

  • Page 27: Stimulation

    Stimulator set-up From the System Menu screen press the Stimulation button. The following stimulation screen will appear:- Scrolling down past the TENS setting reveals further stimulation options:- And more:- Pressing the menu button now would return the screen to the main system menu.
  • Page 28 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 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.
  • Page 29 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 second at the base frequency followed by 1 second at the peak frequency.
  • Page 30 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. 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.
  • Page 31 Russian set-up 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.
  • Page 32 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 Sequential Selection is achieved by pressing the Type button. Combination 860...
  • Page 33 Width: pressing this button opens a new window in which the pulse width may be set from 20 to 400 µs in 5 µs increments by pressing the numerical digits and then pressing OK. Frequency: pressing this button opens a new window. The pulse frequency may be set from 1 to 250 Hz in 1 Hz increments by pressing the numerical digits and then pressing OK.
  • Page 34 Diadynamic set-up 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 - diaphasé fixe, MF - monophasé fixe, CP - modulé en courtes périodes, Cpiso - modulé...
  • Page 35 Sinusoidal set-up 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 section of this manual. The surge pattern may be changed by pressing the surge button.
  • Page 36 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.
  • Page 37 Galvanic set-up 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 selected treatment time) Combination 860...
  • Page 38 Interrupted galvanic set-up 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.
  • Page 39 Träbert 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 Freq: pressing this button opens this window:- The frequency may be set from 2 to 60 Hz in 1Hz increments. Combination 860...
  • Page 40 Mode: Normally Medi-Wave stimulation is used in continuous mode - that is with no modulation (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.
  • Page 41 Electrode error detection When a constant current output is chosen and the unit is operating in 4 or 2 pole interferential, russian, diadynamic, sinusoidal, galvanic or träbert 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...
  • Page 42 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.
  • Page 43 Pressing this causes both outputs to smoothly reduce to zero over a period of 5 seconds. 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.

  • Page 44: Combination

    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.
  • Page 45 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 –...

  • Page 46: Protocols

    Protocols Pressing the Prot button in the ultrasound set-up screen will call up a list of pre-sets tailored for treating various conditions. 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.

  • Page 47: Ultrasound Dose Algorithm

    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. When a transducer is connected and Next is pressed, this screen will appear 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...
  • Page 48 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.

  • Page 49: Maintenance

    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 disinfectants containing sodium hypochlorite. N.B. Isopropyl alcohol is flammable and should be kept away from naked flames.

  • Page 50: Appendix A - Overview Of Treatment Modalities

    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 in the range 500 kHz to 5 MHz.
  • Page 51 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.
  • Page 52 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.
  • Page 53 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.
  • Page 54 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.
  • Page 55 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.

  • Page 56: Appendix B - Technical Specification

    Small ultrasound transducer 1MHz 3MHz 0.6 cm 0.4 cm <5 <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). Combination 860...
  • Page 57 Pulse Duty Temporal peak Mode Frequency Time Cycle to average ratio 250 Hz 2 ms 166 Hz 4 ms 100 Hz 8 ms 50 Hz 18 ms 10% 10:1 The pulse width is fixed at 2 ms Interferential 4-pole Carrier frequency 2 kHz, 4 kHz or 8 kHz 0 –...
  • Page 58 Russian stimulation Carrier frequency 2.5 kHz Modulation frequency 1 – 100 Hz Surges 1:1 to 1:5 Output type 0-100mA peak 0-70V peak Output channels TENS Waveform Asymmetrical, symmetrical or sequential Pulse width 20 – 400 µs Repetition rate 1 – 250 Hz Modulation None, burst or surged Output type...
  • Page 59 Faradic Frequency 50 Hz Surge rate 2 to 30 /minute Surge pattern Rectangular, triangular or trapezoidal Output type 0-70mA peak 0-140V peak Output channels Galvanic Output type 0-70mA peak 0-140V peak Polarity Positive, negative or auto-reverse Output channels Interrupted galvanic Pulse width 10 µs to 1 s for rectangular 1 ms to 1 s for other shapes...
  • Page 60 Medi-Wave Waveform 6 ms differentiated pulse Frequency 2 – 60 Hz Modulation None, burst, surged Output type 0-50mA peak 0-60V peak Output channels Microcurrent Waveform Square wave (50% duty cycle) Frequency 1-1000Hz Output type CC 0-1mA Polarity Positive, negative or auto-reverse Output channels Combination 860...
  • Page 61 Output waveforms Interferential 4-pole Channel A Channel B Carrier Frequency Period Frequency Period 2 kHz 2 kHz 500 µs 1.75-2 kHz 572-500 µs 4 kHz 4 kHz 250 µs 3.75-4 kHz 267-250 µs 8 kHz 8 kHz 125 µs 7.75-8 kHz 129-125 µs In constant current mode the maximum output current per channel is 100 mA peak (70 mA rms).
  • Page 62 Interferential 2-pole 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. Russian stimulation 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).
  • Page 63 TENS Three TENS waveforms are available 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.
  • Page 64 Diadynamic In diadynamic mode the unit produces six different waveforms. The maximum peak output current is limited to 70 mA. DF - diaphasé fixe The DF waveform is a continuous full wave rectified 50 Hz sinewave. rms current = peak current x 0.707 The maximum rms current is 50 mA.
  • Page 65 LP - modulé en longues périodes 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.
  • Page 66 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 √2, or, conversely rms output = peak output x 0.707...
  • Page 67 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 pulses are available from 10 µs to 1 s pulse width and triangular and trapezoidal pulses from 1 ms to 1s.
  • Page 68 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.
  • Page 69 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 requirements for the safety of ultrasonic...

  • Page 70: Appendix C - Emc Tables

    Appendix C - EMC tables 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.
  • Page 71 Guidance and manufacturers declaration – electromagnetic immunity 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.
  • Page 72 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.
  • Page 73 Recommended separation distances between portable and mobile RF communications equipment and the Solo 860 The Primo Combination 860 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Primo 860 can...

  • Page 74: Appendix D - Essential Performance

    Appendix D - Essential performance The performance characteristics essential to the correct operation of the Primo Combination 860 are: Power input 100-240V ac Treatment time 0 – 30 minutes Ultrasound Frequency 1.1 MHz ±5% and 3.4 MHz ±5% Maximum intensity 1.5 W/cm...
  • Page 75 TENS Waveform Asymmetrical, symmetrical or sequential Pulse width 20 – 400 µs in 5 µs increments (±10%) Repetition rate 1 – 250 Hz in 1 Hz increments (±10%) Output type 0-100mA peak (±10%) into 500 0-60V peak (±10%) into 2 k Diadynamic Currents Current types DF, MF, CP, CPiso, RS, LP...
  • Page 76 Träbert Waveform 2 ms on (± 5%), 5ms off (± 5%) rectangular Output type 0-70mA peak (±10%) into 500 0-140V peak (±10%) into 2 k Medi-Wave Waveform 6 ms (± 5%) differentiated pulse Frequency 2 – 60 Hz (± 5%) Output type 0-50mA peak (±10%) into 500 0-60V peak (±10%) into 2 k...
  • Page 77 Combination 860...
  • Page 78 EMS Physio Ltd. Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE T: 0 1 2 3 5 7 7 2 2 7 2 F : 0 1 2 3 5 7 6 3 5 1 8 E : s a l e s @ e m s p h y s i o . c o . u k W e b s i t e : h t t p : / / w w w.

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