Enraf Nonius Sonopuls 490 Operating Instructions Manual
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Enraf Nonius Sonopuls 490 Operating Instructions Manual

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Summary of Contents for Enraf Nonius Sonopuls 490

  • Page 1 4-Series Operating Instructions...
  • Page 2 Copyright: Enraf-Nonius B.V. P.O. Box 12080 Vareseweg 127 3004 GB Rotterdam The Netherlands Tel: +31 (0)10 – 20 30 600 Fax: +31 (0)10 – 20 30 699 info@enraf-nonius.nl www.enraf-nonius.com Part number: 1498751_41 October 31, 2013...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS Foreword ............................4 Intended User/Operator ....................... 4 Product Liability ........................4 Product Description ........................4 Precautionary Instructions ......................5 Intended Use..........................6 Intended Use Electrotherapy ....................6 4.1.1 Pain Management ........................6 4.1.2 Muscle Stimulation ........................6 4.1.3 Description Current Waveforms ....................
  • Page 5 9.2.2 Patient Circuit Interrupted ......................42 9.2.3 Battery Low ..........................42 9.2.4 Water Reservoir Full ......................... 43 9.2.5 Vacuum Leak ..........................43 9.2.6 Ultrasound Applicator Error ...................... 43 9.2.7 Insufficient DC Supply ......................43 User Maintenance ......................43 9.3.1 Optimize Contact Control Ultrasound Applicator ..............43 9.3.2 Back-up and Restore Favorites ....................

  • Page 6: Foreword

    Protocols can run on linked or independent channels. With independent channels two different protocols can be performed simultaneously. Sonopuls 490: The Sonopuls 490 is an ultrasound therapy device. The device provides two positions for attachment of an ultrasound applicator. Depending on the device configuration ordered, the Sonopuls 490 comes with...

  • Page 7: Precautionary Instructions

    The Sonopuls 492 is a combination device, combining the functions of the Endomed 482 and the Sonopuls 490 in a single device. With the Sonopuls 492 the simultaneous application of ultrasound and electrotherapy (combination therapy) is also possible. The remaining electrotherapy channel can then be used independently.

  • Page 8: Intended Use

    4 Intended Use The device is designed to only be used by or under the supervision of persons using the medical device in the course of their work and in the framework of a professional healthcare activity, who understand the benefits and limitations of electrotherapy and ultrasound therapy.
  • Page 9 4.1.2.1 Indications Muscle Stimulation • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis • Maintaining or increasing range of motion •...

  • Page 10: Description Current Waveforms

    4.1.3 Description Current Waveforms 4.1.3.1 4 Pole Interferential Currents With the interferential current type a medium frequency carrier frequency is used to pass the low frequency stimulation (beat) frequency through the skin. The relatively low resistance of the skin to the carrier frequency contributes to the patient comfort that is often associated with this current type.
  • Page 11 4.1.3.1.3 Dipole Vector Manual With the dipole vector technique the currents from the two electrode pairs are vectorially summed in the tissue. The effect is that stimulation only occurs into the direction of the resulting vector, which can be adjusted over a range of 360º. Amplitude modulation occurs in the equipment and the modulation depth is 100%.
  • Page 12 A variation to the standard biphasic asymmetrical pulsed current is the alternating one, in which the successive pulse phases alternate with respect to the baseline. See fig 4.1.4.4.2 for details. This waveform is also fully balanced. To prevent accommodation to stimulation or to improve patient tolerance, the pulse frequency can be varied through frequency modulation.
  • Page 13 Modulation Program defines the time and sequence in which the frequency will sweep through the Frequency modulation range. See for the available Modulation programs fig 4.1.4.12. Surge Program can be used to adjust repeated sequences of contraction and rest periods. See paragraph 8.2.5.6 for details.
  • Page 14 at the Moscow State Academy. Kots used it for muscle strengthening in prosthesiology and in the training of Russian cosmonauts. With this technique the electro stimulation is applied both to individual muscles and to groups (either directly or via the nerve). In direct stimulation, a frequency of 2500 Hz was found to produce the largest contraction, while the optimum frequency in indirect stimulation was 1000 Hz.
  • Page 15 Parameters: Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the twin pulses. See 4.1.4.9 for details. Frequency Modulation, expressed in %, defines a variable frequency range that is subtracted from the Pulse frequency i.e. when the Pulse frequency is set to 80 Hz and the Frequency modulation is set to 50%, the final frequency will vary from 40 –...
  • Page 16 4.1.3.7.5 CPid Is identical to CP, except that the current amplitude during the MF phase is 12.5% lower than during the DF phase. See fig 4.1.4.11.5 for details. Normally a lower frequency is experienced to be more aggressive than a higher frequency. CPid prevents this difference in sensation. Parameters Diadynamic Currents: Surge Program can be used to adjust repeated sequences of contraction and rest periods.
  • Page 17 Phase Duration, expressed in ms or s, is the elapsed time from the beginning to the end of the pulse phase. See fig 4.1.4.5.2 and 4.1.4.5.3 for details. Pulse Frequency, expressed in Hz or pps (pulses per second), defines the repetition rate of the current pulses.

  • Page 18: Illustrations Current Waveforms

    4.1.4 Illustrations Current Waveforms 4.1.4.1 Premodulated / Isoplanar vector / Dipole vector Carrier frequency Beat frequency  4.1.4.2 Russian Stimulation Carrier frequency Burst frequency  4.1.4.3 Biphasic Pulsed Current TENS 4.1.4.4 4.1.4.4.1 Asymmetrical Phase duration Pulse frequency   4.1.4.4.2 Asymmetrical Alternating ...
  • Page 19 4.1.4.4.4 Burst Asymmetrical Alternating Burst frequency   4.1.4.4.5 Symmetrical Phase duration  Phase interval Pulse frequency  4.1.4.4.6 Burst Symmetrical Burst frequency          4.1.4.5 Faradic Current 4.1.4.5.1 Träbert, 2 – 5 Current Phase duration: 2 ms Phase interval: 5 ms ...
  • Page 20 4.1.4.6 Galvanic Current 4.1.4.7 Galvanic Interrupted Carrier frequency - 8 kHz fixed Duty cycle - 90 % fixed  4.1.4.8 Galvanic Continuous 4.1.4.9 High Voltage  Peak interval - 64 µs fixed Pulse frequency  4.1.4.10 Micro Current Frequency 4.1.4.11 Diadynamic Current 4.1.4.11.1 MF 4.1.4.11.2 DF...
  • Page 21 4.1.4.11.3 LP 4.1.4.11.4 CP 4.1.4.11.5 CPid...
  • Page 22 4.1.4.12 Modulation program 4.1.4.12.1 Modulation program 1/1 Pulse frequency  Frequency modulation  4.1.4.12.2 Modulation program 6/6 or 12/12 6 : 6 or 12 : 12 Pulse frequency  Frequency modulation 4.1.4.12.3 Modulation program 1/30 1 : 30 Pulse frequency  Frequency modulation ...

  • Page 23: Intended Use Ultrasound Therapy

    Intended Use Ultrasound therapy Ultrasound is a mechanical energy consisting of high-frequency vibrations applied by means of an ultrasound applicator. These vibrations pass through the tissue of the body and are gradually absorbed and transformed into heat. The resulting temperature increase triggers biological changes to occur in the tissue for the relief of pain, relaxation of muscle spasms and reduction of joint contractures.

  • Page 24: Potential Adverse Effects Ultrasound

    The package contents depend on the device model ordered. The following models are available: 1498901 Sonopuls 490 with large ultrasound applicator 1498902 Sonopuls 490 with small ultrasound applicator 1498903 Sonopuls 490 with large and small ultrasound applicator 1498911 Sonopuls 492 with large ultrasound applicator 1498912 Sonopuls 492 with small ultrasound applicator 1498913...

  • Page 25: Installation

    Standard accessories 4-Series: 1498010 Device base (inclination support) (not for Vacotron 460) 3440001 Screwdriver 3444290 Power cord 250V/10A Europe-3x1 mm2 2.5 meter black 1498756 4-Series Information Booklet 1498757 4-Series Operating Instructions (cd rom) Standard accessories ultrasound: 0167154 Information sheet ultrasound gel 0167314 Information sheet Mounting US Head Holder(s) 1498011...

  • Page 26: Disconnection From Mains Supply

    CAUTION: • Do not place the device in a location where the power cord could be tripped over or pulled out during treatment. • Do not attempt to use the device if it is not properly grounded. Make certain that the device is electrically grounded by connecting it only to a grounded electrical service receptacle conformable with the applicable national and local electrical codes regarding medical environments.

  • Page 27: Application Information

    • When you have finished treatments turn off the device using push button [4]. With the power line switch [1] On (1), the battery is automatically charged, independent of the state of the on/off push button [4]. We recommend to use the apparatus from the powerline whenever possible. This will increase the service life of the battery.

  • Page 28: Vacuum Electrodes

    7.1.3 Vacuum electrodes There is a choice of large and small electrodes. The areas of the electrodes correspond to those of the 4 x 6cm and 6 x 8cm flexible rubber electrodes. The vacuum electrodes are sufficiently flexible to ensure optimum contact with the skin, but rigid enough to prevent any changes in the contour of the part being treated, allowing full advantage to be taken of the massage effect of the pulsed vacuum.

  • Page 29: Ultrasound

    Ultrasound 7.2.1 Contact Control The ultrasound applicator has a contact control function that suspends treatment when the acoustical contact with the body drops below a certain level (see paragraph 10.1). The indicator light on the applicator is turned on to signal this situation, the ultrasound Amplitude display will start blinking and the treatment timer will stop counting down.

  • Page 30: Operating Instructions

    • See paragraph 7.1.3 for the application of the vacuum electrodes. • When you use only one vacuum channel, close the other channel with one of the vacuum cables not in use. • See paragraph 8.2.3.4 for operating the vacuum unit. 8 Operating Instructions Operator Controls Power line switch...
  • Page 31 CAUTION: • The supply current of this connection is limited to 100 mA. Do not connect USB mass storage devices such as USB powered hard disks, as this might result in data loss. Only USB-sticks are allowed. On/Off push button: This button is used to turn the device On or Off Power LED indicator: Green:...

  • Page 32: Basic Operation

    Basic Operation 8.2.1 Device turn on • Turn on the apparatus as described in paragraph 6.3 8.2.2 Display Organization The display is organized as a spreadsheet of 3 sheets, one for each channel. The channels refer to the patient connector groups accessible at the front of the unit. A sheet can be selected by touching its tab. The tab shows important information, such as the output amplitude and the remaining treatment time.

  • Page 33: Navigation

    To adjust the output amplitude of a channel, touch the tab of the selected channel again. Its colour will change into orange. The output amplitude can now be adjusted with the central controller [7]. For some applications, such as interferential therapy and combination therapy, two adjacent channels can be linked.
  • Page 34 Therapy information Use the central controller to scroll through the pages, in most cases the first page is text followed by one or more illustrations. Touch the accept button  in the navigation bar. The channel selection screen appears. Channel Selection Here you can select the channels for electrotherapy.
  • Page 35 Electrotherapy “Manual Operation” The electrotherapy menu gives access to functions • Clinical Protocols • Favorites • Manual Operation • Programming Select Manual Operation by touching the button The next screen appears Select from the list a current waveform Scroll to the next page with the central controller [7] or select the current waveform by touching the button Note: some of these selections are groups and in the next screen another list appears from which the current wave can be selected.
  • Page 36 Treatment time adjustment Touch the timer button, the color changes into silver and adjust the treatment time with the central controller [7] Repeat this for all other parameters. Start the therapy by adjusting the intensity with the central controller • To pause the treatment, touch the pause button in the navigation •...
  • Page 37 Therapy information Use the central controller [7] to scroll through the pages, in most cases the first page is text followed by one or more illustrations. Touch the accept button  in the navigation bar. The parameter screen appears. Touch the accept button ...
  • Page 38 The Combination menu gives access to functions • Clinical Protocols • Favorites • Manual Operation Select Manual Operation by touching the button The next screen appears Select in this menu the current waveform by touching the button Adjust the current parameters and treatment time •...
  • Page 39 • Touch the ultrasound read-out and adjust the intensity with the central controller [7] • Touch the current read-out channel 2 to adjust the current intensity. (electrode and treatment head need to be in contact with the patient) 8.2.3.4 Vacuum If a unit is equipped with a Vacotron it’s possible to select either rubber electrodes or vacuum cups.
  • Page 40 • Enter the name of your favorite using the keyboard. • Touch  to store your favorite under the name just entered. Notes: • Once saved, favorites can be retrieved from the Electrotherapy, Ultrasound Therapy and Combination Therapy menus. • 4-polar treatments are automatically saved and loaded as a dual channel treatment.

  • Page 41: Shutting Device Down

    In this screen you can personalize the unit. Several settings can be changed or adjusted. • Language, touch the language button and select the desired langue using the central controller [7]. Touch the language button again or touch another button to confirm. •...
  • Page 42 Ultrasound Applicator B Channel Status Channel stopped Channel paused Channel running Remaining treatment time. When a sequential protocol has been loaded, the value indicates the total remaining treatment time of the sequential protocol. Output value Unit of Output value: µA, mA, V, W, W/cm 8.2.5.3 Adjusting current amplitude To adjust the output current, touch the tab of the selected channel.

  • Page 43: Maintenance And Troubleshooting

    Ramp-up time, expressed in s, defines the time in a surge program during which the current is increased from 0 to the adjusted level. See fig 4.1.4.13 for details. The ramp-up time can be adjusted in increments of 0.1s. Hold time, expressed in s, defines the time in a surge program during which the current is kept at the adjusted level.

  • Page 44: Vacuum Electrodes And Sponges

    9.1.6 Vacuum electrodes and sponges The vacuum electrodes and sponges should be cleaned with lukewarm water. In the case of persistent dirt, and for disinfection, a 70% alcohol solution may be used. Sponges should be replaced regularly. It is recommended to keep sponges and a spare electrode in stock.

  • Page 45: Water Reservoir Full

    9.2.4 Water Reservoir Full The water separation tank of the Vacotron is full. Continue the treatment with the standard electrodes or empty the tank as follows: • Set power line switch [1] Off (0). • Detach the hose from the upper hose nipple [15] and empty the reservoir. •...

  • Page 46: Firmware Update

    • Detach the USB-stick 9.3.3 Firmware Update If your system requires a Firmware Update, contact your supplier to obtain a USB-stick containing the latest firmware version. Your current firmware version can be viewed under System Settings. To update your firmware proceed as follows: •...

  • Page 47: Specifications

    10 Specifications 10.1 Ultrasound parameters  Continuous ultrasound Explanation of symbols: Ultrasonic radiation with an acoustic working frequency of 1 or 3 MHz Pulse repetition rate Duty cycle Pulse duration  Pulsed ultrasound  Ultrasound parameters: Acoustic working frequency: 1MHz or 3MHz Pulse repetition rate: 16, 48 and 100 Hz Duty cycle: 5 –...

  • Page 48: Stimulator Output Parameters

    Output meter uncertainty : ± 20 % for any output above 10 % of maximum Pulse frequency : 16, 48 and 100 Hz ± 1 % Duty cycle : 5 – 80 % and 100 % (100 % is continuous wave) Pulse duration : 0.5 –...
  • Page 49 The maximum current amplitude within the specification is achieved up to a load of 500 Ω (CC). Surge program With some current waveforms a surge program is available. The parameters and their range are as follows: Ramp-up time : 0 - 9 s, in steps of 1s Hold time : 0 - 60 s, in steps of 1 second Ramp-down time...
  • Page 50 Burst Frequency : 1 – 9 Hz, in steps of 1 Hz Amplitude : 0 - 140 mA Symmetrical Phase Duration : 10 - 400 µs in steps of 5 µs Pulse Frequency : 1 - 200 Hz, in steps of 1 Hz Frequency Modulation (spectrum) : 0 - 180 Hz in steps of 1 Hz Modulation Program...

  • Page 51: Technical Data

    Surge Program : on MF and DF Polarity : Positive or Negative Amplitude : 0 - 70 mA MF interrupted galvanic current Frequency : 8000 Hz Duty cycle : 90% Polarity : Positive or Negative Amplitude : 0 - 40 mA Direct Galvanic current Polarity : Positive or Negative...

  • Page 52: Safety And Performance Standards

    10.4 Safety and Performance standards IEC 60601-1 : General requirements for the safety of electrical medical systems, including Annex 1, national differences for Australia, Canada and the United States. Safety class according to IEC 60601-1: class I type BF IEC 60601-2-5 : Particular requirements for the safety of ultrasonic therapy equipment.
  • Page 53 The device should not be used when placed immediately next to or stacked on top of other devices. If operation is necessary when immediately next to or stacked on top of other devices, the device should be monitored to ensure it is operating as intended in this arrangement. Guidance and manufacturer’s declaration –...
  • Page 54 The main features of the 4-series devices are as follows: interference-free delivery of shockwaves, interference-free control of all functions. Uninterrupted operation is not required with the use intended. Guidelines and manufacturer's declaration – electromagnetic interference immunity The 4-series device is intended for operation in the electromagnetic environment specified below. The customer or user of the 4-series should ensure that it is used in such an environment.

  • Page 55: Ordering Information

    Model numbers: 1498901 Sonopuls 490 with large ultrasound applicator 1498902 Sonopuls 490 with small ultrasound applicator 1498903 Sonopuls 490 with large and small ultrasound applicator 1498911 Sonopuls 492 with large ultrasound applicator 1498912 Sonopuls 492 with small ultrasound applicator 1498913...
  • Page 56 Standard accessories Sonopuls 490: 1498757 4-Series Operating Instructions (cd rom) 1498756 4-Series Information Booklet 3444290 Mains cable 230V-EUR 1498010 Device base (inclination support) (not for Vacotron 460) xxxxxxx Ultrasound multi-frequency treatment head(s) (model dependent) xxxxxxx Holder treatment head (model dependent)
  • Page 57 Point electrodes 1480800 Electrode holder for 1480801 1480801 Point electrode 5 mm, 4 mm female (in combination with adapters 2523523 / 2523524) 1460369 Point electrode, 17 mm, 4 mm female (in combination with adapters 2523523 / 2523524) Adapters 2523524 Adapter plug, 2 mm female, 4 mm male, red 2523523 Adapter plug, 2 mm female, 4 mm male, black Patient cable...

This manual is also suitable for:

Sonopuls 492Vacotron 460Endomed 482

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