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EMS Physio 122 Скачать руководство пользователя страница 56

Interferential 960/Multidyne 970

56

The Interferential 960/Multidyne 970 has been designed to meet the
requirements of BS EN 60601-1:2006 "Medical Electrical Equipment, Part
1:General requirements for Safety", 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.

Appendix C – EMC tables

Guidance and manufacturers declaration – electromagnetic emissions

2

The Primo Interferential 960/Multidyne 970 is intended for use in the
electromagnetic environment specified below. The customer or the user of the
960/970 should assure that it is used in such an environment.

3

Emissions test

Compliance

Electromagnetic environment -
guidance

4

RF emissions
CISPR 11

Group 1

The 960/970 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.

6

RF emissions
CISPR 11

Class A

The 960/970 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.

7

Harmonic
emissions
IEC 6100-3-2

not
applicable

8

Voltage
fluctuations
Flicker emissions
IEC 61000-3-3

not
applicable

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Содержание 122

Страница 1: ...User Manual INTERFERENTIAL 960 MULTIDYNE 970 Model 122 123 ...

Страница 2: ...Interferential 960 Multidyne 970 2 ...

Страница 3: ...ity to 93 42 EEC 5 Warranty 6 Introduction and indications for use 7 Contraindications 8 Accessories 9 Controls and markings 11 Installation 15 Operating instructions 16 Maintenance 41 Appendix A overview of treatment modality 42 Appendix B technical specification 44 Appendix C EMC Tables 56 Appendix D essential performance 60 ...

Страница 4: ...anguage without the prior written consent of EMS Physio Ltd The Interferential 960 is an interferential electrotherapy unit The Multidyne 970 unit is a multiple waveform electrotherapy unit The 970 provides a complete range of low and medium frequency waveforms for electrotherapy and electro diagnostics It is intended that the Multidyne 970 unit is only used by qualified healthcare professionals s...

Страница 5: ...ted 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 IIb according to Annex IX of 93 42 EEC Signature M Bowles Position Operations Dir...

Страница 6: ...oved agents The Company will consider itself responsible for the effects on safety reliability and performance of the product only if assembly operations re adjustments modifications or repairs are carried out by persons authorised by it only if the product is used in accordance with the instructions for use only if the electrical installation of the relevant room complies with the appropriate nat...

Страница 7: ... may produce instability in the stimulator output Consideration must be given to the current densities for any electrode used with the Multidyne 970 Unit Current densities greater than 2 mA rms cm2 are not recommended because of the risk of burning All the standard EMS conductive rubber electrodes may be used up to the maximum output of the unit without exceeding this figure When using other elect...

Страница 8: ...anted electronic device unless specialist medical opinion has first been obtained Febrile conditions Large open wounds in treatment area Dermatological conditions in treatment area Thrombosis Hypersensitivity or fear of electrical treatments Any patient who cannot understand the nature of the treatment for example young children very old or senile patients who cannot report back adequately or unde...

Страница 9: ...52B 4 small 70 x 50 mm conductive rubber electrodes NC3054A 4 large sponge electrode covers for NC3054B NC3054B 4 large 130 x 100 mm conductive rubber electrodes NC3041 Electrode handle for circular pad 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 ...

Страница 10: ...shown below EMS Part Number Description 6 85 UK mains lead 6 112 European mains lead 6 119 North America mains lead For other countries contact EMS Physio Ltd or the agent from whom the unit was purchased 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 ...

Страница 11: ...ls and markings Interferential 960 Multidyne 970 front panel IEC symbol 878 02 03 Type BF Equipment IEC Symbol 348 Attention consult accompanying documents Stimulator Output IEC symbol 7000 1641 Instructions for use IEC symbol 878 01 37 Output ...

Страница 12: ... not dispose of as unsorted waste 2006 96 EC WEEE Directive Name and Address of Manufacturer IEC symbol 348 Attention consult accompanying documents IEC symbol 7000 1641 Instructions for use Model number and classification Serial number and date of manufacture Stimulation output levels ...

Страница 13: ...erferential 960 Multidyne 970 13 Multidyne 970 top The Interferential 960 is identical except for the model label LCD touch panel IEC symbol 848 01 26 variability in steps Output control knob On Off button ...

Страница 14: ...Interferential 960 Multidyne 970 14 FOR USE WITH EMS STIMULATORS B A 1 2 1 2 TOP Patient Lead PMA3055 Electrode connecting cables A B 1 2 12 1 2 ...

Страница 15: ... rechargeable battery may be used powered by the battery only The Interferential 960 Multidyne 970 unit is supplied with four medium sized electrotherapy electrodes with their associated patient lead Plug the patient lead into the socket on the front of the unit and connect the electrodes to the yellow and blue cables The plug has an arrow and the word top embossed on it to aid correct orientation...

Страница 16: ...information When the Interferential 960 Multidyne 970 is turned on the EMS company logo is displayed on the LCD along with the company web address the model name and the firmware version The unit will then give a short beep and display the System Menu screen Interferential 960 Multidyne 970 ...

Страница 17: ...tate of the battery indicates a completely discharged battery and a fully charged battery The arrow 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 batte...

Страница 18: ...o 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 and Key click allows you to turn on or off the beep that happens whenever the screen is touched Touching the About button displays the model name and the installed...

Страница 19: ...The settings shown on the file card will be loaded and the user will be returned to the 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 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 progr...

Страница 20: ...tons on the LCD touchscreen The rotary control is used to increase and decrease the stimulation intensity 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 The menu button is used to exit from the current screen or to ...

Страница 21: ...g this button selects 4 8 or 2 kHz carrier frequency AMF Pressing this button opens the AMF window 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...

Страница 22: ...e 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 ...

Страница 23: ...hrough 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 Two channels are available with independent intensity control corresponding to electrode pairs A yellow and B blue Adjustment is achieved by pressing and holding the relevant...

Страница 24: ... 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 to 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 t...

Страница 25: ...aveform types are available and each type is represented graphically on the LCD Selection is achieved by pressing the Type button 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 Asymmetrical Symmetrical Sequential ...

Страница 26: ...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 may be set to be constant current CC or constant voltage CV by pressing the CC CV button ...

Страница 27: ...s 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 t...

Страница 28: ...se 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 CC CV The output may be set to be constant current CC o...

Страница 29: ...urge 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 CC CV The output may be set to be constant current CC or co...

Страница 30: ...ly 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 CC CV The output may be set to be constant current CC or constant voltage CV ...

Страница 31: ...is 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...

Страница 32: ...e 970 only 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 ...

Страница 33: ...y 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 Multidyne 970 only 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 sel...

Страница 34: ...ent time must be entered to complete the S D test 10minutes should be more than adequate With the correct electrodes ball muscle testing electrode and large dispersive pad electrode in place over the muscle to be tested slowly increase the output until a muscle contraction is detected The screen will be showing a flashing Treatment sign and the axes of the S D graph will be displayed The graphic i...

Страница 35: ... Repeat this process until the End pulse width is reached The S D curve is now plotted Waiting for or pressing Stop or manually reducing the output to zero will cause the Rheobase and Chronaxie to be calculated and displayed Pressing OK will return to the S D curve set up screen to allow another test to be run Pressing Menu at this point will return to the main System Menu screen ...

Страница 36: ...er the required current then the output of the Interferential 960 Multidyne 970 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 continuing treatment I...

Страница 37: ...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 sti...

Страница 38: ...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 ...

Страница 39: ...tton 960 or the Prot in the 4 Pole interferential mode set up screen 970 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 treatment settings for that particular condition ...

Страница 40: ...n 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 f...

Страница 41: ...atment leads cables and connectors for signs of damage The Interferential 960 Multidyne 970 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...

Страница 42: ... can help in the reduction of oedema and produce an increase in circulation in the treated area Faradic pulses are of short duration less than 1 ms and have a repetition rate of 50 Hz They are normally surged to produce rhythmical muscle contraction Galvanic or direct current is used for pain relief and iontophoresis The Multidyne 970 produces a wide range of interrupted galvanic pulses Rectangula...

Страница 43: ...e 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 ...

Страница 44: ...ial 4 pole 960 970 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 960 970 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 Rus...

Страница 45: ...ypes DF MF CP CPiso RS LP Output type CC 0 70mA peak CV 0 140V peak Polarity Positive negative or auto reverse Output channels 2 Sinusoidal 970 only Frequency AMF 50 Hz Surge rate 2 to 30 minute Surge pattern Rectangular triangular or trapezoidal Output type CC 0 70mA peak CV 0 140V peak Output channels 2 Faradic 970 only Frequency 50 Hz Surge rate 2 to 30 minute Surge pattern Rectangular triangul...

Страница 46: ...peak CV 0 140V peak Polarity Positive negative or auto reverse Output channels 2 Träbert 970 only Waveform 2 ms on 5ms off rectangular Output type CC 0 70mA peak CV 0 140V peak Polarity Positive negative or auto reverse Output channels 2 Medi Wave 960 970 Waveform 6 ms differentiated pulse Frequency 2 60 Hz Modulation None burst surged Output type CC 0 50mA peak CV 0 60V peak Output channels 2 Mic...

Страница 47: ...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 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 ...

Страница 48: ...re 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 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 ...

Страница 49: ...z 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...

Страница 50: ...ixe The MF waveform is a continuous half wave rectified 50 Hz sinewave rms current peak current x 0 5 The maximum rms current is 37 5 mA CP modulé en courtes périodes 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 modulé en courtes périodes isodynamique Th...

Страница 51: ... alternate phase increases in amplitude is shown above RS rythme syncopé The RS waveform 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 wavefo...

Страница 52: ...0 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 Three standard surge patterns are provided The rest rise hold and fall times for each pattern as a percentage of the complete surge cycle are shown below Pattern Rest Rise Hold Fall Rectangular 50 5 40 5 Triangular 50 33 16 1 Trapezoidal 50 25 13 12...

Страница 53: ...e 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 The pulse repetition rate is from 2 to 30 pu...

Страница 54: ...tensity control Pos Neg or autorev polarities are selectable 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 minute Two channels of o...

Страница 55: ...es for plotting strength duration curves Only channel A is energised in this mode and the peak output voltage is 140V Environmental conditions for transport and storage Temperature 10 to 35 C Relative humidity 5 to 95 Atmospheric pressure 500 to 1060 hPa Output display The Interferential 960 Multidyne 970 display shows the peak current or peak voltage of each output channel depending on whether co...

Страница 56: ...tended for use in the electromagnetic environment specified below The customer or the user of the 960 970 should assure that it is used in such an environment 3 Emissions test Compliance Electromagnetic environment guidance 4 RF emissions CISPR 11 Group 1 The 960 970 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference i...

Страница 57: ...Interferential 960 Multidyne 970 57 ...

Страница 58: ...IEC61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 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 5 UT 95 dip in UT For 5 sec ...

Страница 59: ...ransmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol 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 f...

Страница 60: ...maximum output power of the communications equipment 150kHz to 80MHz d 3 5 P V1 80MHz to 800MHz d 3 5 P E1 800MHz to 2 5GHz d 7 P E1 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...

Страница 61: ...50 Hz in 1 Hz increments 2 Swing pattern 1 1 6 6 or 6 6 Output type CC 0 100mA peak 10 into 500 Ω CV 0 70V peak 10 into 2 k Ω Interferential 2 pole Carrier frequency 2 kHz 4 kHz or 8 kHz 5 AMF 0 250 Hz in 1 Hz increments 2 Swing pattern 1 1 6 6 or 6 6 Output type CC 0 100mA peak 10 into 500 Ω CV 0 70V peak 10 into 2 k Ω Russian stimulation Multidyne 970 only Carrier frequency 2 5 kHz 5 Modulation ...

Страница 62: ... Surge pattern Rectangular Triangular or Trapezoidal Output type CC 0 50mA peak 10 into 500 Ω CV 0 100V peak 10 into 2 k Ω Faradic Multidyne 970 only Frequency 50 Hz 5 Surge rate 2 to 30 minute 10 Surge pattern Rectangular Triangular or Trapezoidal Output type CC 0 50mA peak 10 into 500 Ω CV 0 100V peak 10 into 2 k Ω Galvanic Multidyne 970 only Output type CC 0 70mA peak 10 into 500 Ω CV 0 140V pe...

Страница 63: ... 10 into 500 Ω CV 0 140V peak 10 into 2 k Ω Medi Wave Waveform 6 ms 5 differentiated pulse Frequency 2 60 Hz 5 Output type CC 0 50mA peak 10 into 500 Ω CV 0 60V peak 10 into 2 k Ω Microcurrent Multidyne 970 only Waveform Square wave 50 duty cycle Frequency 1 1000Hz Output type CC 0 1mA 20 Polarity Positive Negative or Auto reverse ...

Страница 64: ...Interferential 960 Multidyne 970 64 ...

Страница 65: ...erferential 960 Multidyne 970 65 EMS Physio Ltd Grove Technology Park Downsview Road Wantage Oxfordshire OX12 9FE UK T 01235 772272 F 01235 763518 E sales em sphysio co uk Website http www em sphysio co uk ...

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