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EN109-1498751-47

Enraf-Nonius B.V.
Vareseweg 127 | 3047 AT | Rotterdam | The Netherlands
Tel: +31 (0)10-20 30 600 | [email protected]

Содержание 1498.901

Страница 1: ...sible for the results of using this device for any purposes other than described in these operating instructions If the use of this device may have caused or contributed to an undesirable event such as death or serious injury to the user the manufacturer AND the competent authority of the Member State MUST be notified immediately EN109 1498751 47 IFU January 16 2020 Instructions for use ...

Страница 2: ...13 6 Intended use and intended user 15 7 Indications 16 8 Contraindications 17 9 Precautionary instructions 20 10 General instructions 21 11 Operation 23 12 Application information 39 13 Description Current waveforms and Ultrasound parameters 42 14 Maintenance and troubleshooting 63 15 Specifications 68 16 Contact 70 17 Product liability 70 ...

Страница 3: ...ed 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 an ultrasound head with a large contact area an ultrasound treatment head with...

Страница 4: ...Page 4 of 72 EN109 1498751 47 IFU The device is placed beneath the Endomed 482 or Sonopuls 492 from which its power is derived and through which it is also operated ...

Страница 5: ...ied requirements to provide protection against electric shock particularly regarding allowable patient leakage current and patient auxiliary current Type BF applied part complying with the specified requirements to provide a higher degree of protection against electric shock than that provided by type B applied parts Temperature Range Indicates acceptable temperature range Humidity Limits Indicate...

Страница 6: ... identified CE Mark along with number indicates conformity with European Council of directive concerning Medical Devices and this device is under the direct supervision of the Notified Body Connection electrode cable electrotherapy Connections vacuum cables electrotherapy Remote control connection On Off push button ...

Страница 7: ...ins cable here to power the device Provides information on the apparatus such as type and serial number as well as connection data such as mains voltage and maximum current consumption 3 Remote Control connection This connection has two functions 1 Attachment of optional remote control unit Used to remotely adjust the output current on the electrotherapy channels or to stop the treatment on all ch...

Страница 8: ...light ring is illuminated when the controller is ready to use 8 Connection for Electrode Cable Electrotherapy channel 1 Connection point for the patient cable for Channel 1 9 Connection for Electrode Cable Electrotherapy channel 2 Connection point for the patient cable for Channel 2 10 Multifunctional Connector for accessories Channel A Connection point to connect accessories such as Ultrasound he...

Страница 9: ...ent leads for Channel 2 14 Interconnection cable vacuum unit to main unit Connection cable to connect the Vacuum unit with the main unit 15 Upper hose nipple Air inlet for draining the Vacuum Tank See instructions Vacuum Unit Connections 8 9 12 13 are intended for the connection of type BF applied parts complying with the leakage current requirements of IEC 60601 1 Connections 10 11 are intended f...

Страница 10: ...05 Ultrasound Head Large 1630 915 Ultrasound Head Small Standard accessories for 4 series Part Number Description 1498 010 Device base inclination support not for Vacotron 460 3440 001 Screwdriver 3444 290 Power cord 250V 10A Europe 2 5 meter black 1498 756 4 series Information Booklet 1498 757 4 series Instructions for Use CD ROM Standard accessories ultrasound Part Number Description 0167 154 In...

Страница 11: ...ption 3444 222 Adhesive electrodes Ø 2 0 cm 2 mm female 10 sheets of 8 also for EMG 3444 056 EN Trode Ø 3 2 cm 2 mm female 10 sheets of 4 3444 135 EN Trode Ø 5 0 cm 2 mm female 10 sheets of 4 3444 057 EN Trode 5x5 cm 2 mm female 10 sheets of 4 3444 058 EN Trode 5x9 cm 2 mm female 10 sheets of 4 Rubber electrodes Part Number Description 3444 128 Rubber electrodes 4x6 cm 2 mm female set of 2 3444 12...

Страница 12: ...es Bag Part Number Description 3444 675 Carrierbag 4 series Battery Part Number Description 2501 016 Battery 12 0V 1 8AH Vacuum accessories Vacotron 460 Part Number Description 3444 509 Vacuum electrodes Ø 30 mm set of 2 3444 503 Vacuum electrodes Ø 60 mm set of 2 3444 504 Vacuum electrodes Ø 90 mm set of 2 3444 516 Sponges Ø 30 mm set of 4 for vacuum electrodes Ø 30 mm 3444 505 Sponges Ø 65 mm se...

Страница 13: ...during shipment Place the main device on top of the vacuum unit Carefully lift the main device at the front and insert flat cable 17 into connector 18 Connection to mains supply Use of any other cable other than the supplied cable is strictly PROHIBITED as it affects patient safety and the proper function of the device Do not place the device in a location where the power cord could be tripped ove...

Страница 14: ...y Leave power line switch 1 in the Off position 0 and turn on the device on using push button 4 Power LED indicator is lit orange indicating that the device is operating from the battery The charge status of the battery is indicated in the right hand top corner of the display When you have finished the treatments turn off the device using push button 4 With the power line switch 1 to On 1 the batt...

Страница 15: ...is the use of electrical stimulation to treat muscle dysfunction Combination therapy Combination therapy is the combined application of ultrasound and electrical stimulation With combination therapy the metal surface of the ultrasound treatment head becomes the negative electrical stimulation electrode while the lead wire with the red connector remains the positive electrical stimulation electrode...

Страница 16: ...cle re education Immediate post surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Dysphagia Ultrasound therapy Ultrasound is indicated for conditions that benefit from the application of deep heat relief of pain muscle spasms and joint contractures The objective of therapeutic ultrasound in the treatment of selected medical conditions assoc...

Страница 17: ...ed Electrode placements that apply current trans cerebrally through the head must be avoided Electrode placements that apply current trans thoracically the introduction of electrical current into the heart may cause cardiac arrhythmias must be avoided Note However the application area for the treatment of Dysphagia is distant enough from the sinus carotis area when the therapist follows the guidel...

Страница 18: ...ronic electrical stimulation are unknown Safety has not been established for the use of therapeutic electrical stimulation during pregnancy Stimulation should not be applied over swollen infected or inflamed areas of skin eruptions e g phlebitis thrombophlebitis varicose veins etc Isolated cases of skin rash may occur at the site of electrode placement following long term applications The irritati...

Страница 19: ...plying heat to the eyes Treatment of the facial sinus exposes the eyes to the same hazards Treatment of the thyroid as well as lymph nodes in the neck may expose the patient to as yet undetermined effects in as much as the safety of such treatments has not yet been established Potential adverse effects Electrotherapy When treated for Muscle Stimulation Skin irritation and etching beneath the elect...

Страница 20: ... The device should not be used when any sort of mechanical damage is noticed Do not operate the unit in an environment of short wave or micro wave diathermy Caution Always determine the dosage based on the patient s perception of heat Any sensation greater than mild warmth could cause a burn Do not operate the 4 series when connected to any unit other than Enraf Nonius B V devices Do not use this ...

Страница 21: ...d ultrasound amplitude can vary around the set value caused by fluctuations in acoustical coupling The patient is regularly asked to report any sensations felt If necessary the treatment is modified The intensity can be reduced or a switch is made from continuous to pulsed ultrasound If there are indications of poor transfer of the ultrasound energy the contact medium can be reviewed if necessary ...

Страница 22: ...l of grease with soap or 70 alcohol Shaving hairy skin is recommended Test the sensitivity of the treatment area Position the electrodes and or sponges do not forget to moisten During treatment Intensity is set at the desired level The patient is regularly asked to report any sensations felt If necessary the treatment is modified Ending treatment Treatment can be stopped by pressing the stop icon ...

Страница 23: ...channel or when no channels are selected the menu buttons H Channel tab Used to select a channel and to display and adjust the output amplitude of that channel See paragraph Channel tab information for details FIGURE 1 A selected sheet gives an overview of the parameters belonging to that channel A parameter can be selected by touching it which causes its colour to be changed into white and the li...

Страница 24: ...sequential protocol in a favorite Delete favorite Pause treatment The output current decreases to 0 and the treatment timer suspends counting down Start Continue treatment The output current increases to the previous value and the treatment timer resumes counting down Accept the selected option Stops treatment on all channels simultaneously Channel tab information Channel Tab Illustration I J K L ...

Страница 25: ...one the negative connection Manually changing the polarity during a treatment will result in a current decaying to 0 followed by a current with the opposite polarity rising to a value equal to 80 of the previous value Surge programs Surge programs allow you to program sequential increases and decreases in current amplitude See Figure 30 for details Surge programs should not be confused with protoc...

Страница 26: ...ay time expressed in seconds defines the time delay between the start of the surge program on channel 1 and channel 2 See Figure 30 for details The delay time can be adjusted in increments of 0 1 second Beep if enabled generates a short beep at the start of each surge Navigation Electrotherapy Home The Home menu gives access to all functions of the unit Select the desired function or therapy by to...

Страница 27: ...ear 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 When channel 1 is selected channel 2 is still available for another therapy When Channel 1 2 ...

Страница 28: ...t available the user can set the vacuum settings direct from the menu Intensity setting To set the intensity touch sheet 1 Channel 1 Read out change to orange colour and adjust with the central controller Timer starts count down Electrotherapy Manual Operation The electrotherapy menu gives access to functions Clinical Protocols Favorites Manual Operation Programming Select Manual Operation by touc...

Страница 29: ...eform can be selected Channel Selection Here you can select the channels for electrotherapy When channel 1 is selected channel 2 is still available for another therapy When Channel 1 2 is selected both channels have the same parameters Only the intensity can be set differently Parameter screen Adjust the parameters by touching the button and change the value with the central controller 7 Note some...

Страница 30: ...usting the intensity with the central controller 7 To pause the treatment touch the pause button in the navigation bar To continue the treatment touch the run button in the navigation bar To Stop the treatment touch the STOP button in the navigation bar Ultrasound Therapy The Home menu gives access to all functions of the unit Select in the Home menu ultrasound therapy by touching the button Ultra...

Страница 31: ...pears Use the central controller to scroll through the list and select the clinical protocol by touching the button For therapy information touch the info button left of the protocol and the therapy info will appear 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 n...

Страница 32: ...ected channel B is still available for another therapy Functionality may be limited if the dual channel mode is not activated The count down starts when there is sufficient contact between the applicator and the treatment surface Parameters can always be changed before or during the treatment Note the light ring on the ultrasound treatment head will turn off when sufficient contact is established ...

Страница 33: ... of the unit Select in the Home menu combination therapy by touching the button Combination Therapy The next screen appears 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 ...

Страница 34: ... channels for Ultrasound Note A notification may appear if there are more than 1 Ultrasound treatment head connected Follow the instructions of the notification Adjust the current parameters and treatment time Touch the parameter button and adjust with the central controller 7 ...

Страница 35: ... 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 when in CC mode Vacuum If a unit is equipped with a Vacotron it s possible to select either rubber electrodes or vacuum cups Touch the button and adjust the pressure using the central controller 7 The vacuum cups are automatically s...

Страница 36: ...reatment has not been started a Store button is available on the navigation bar To store your settings touch the Store button in the Navigation bar Enter the name of your Favorite using the keyboard Touch to store your Favorite under the name just entered Note Once saved Favorites can be retrieved from the Electrotherapy Ultrasound Therapy and Combination Therapy menus 4 polar treatments are autom...

Страница 37: ... set as required touch the next button to add a next step Continue with the remaining treatment steps until you have reached the end of your protocol Touch the Store button in the navigation bar Enter the name of your sequential protocol as described in paragraph Storing Favorites Sequential protocols are stored under the Favorite menu System Settings The Home menu gives access to all functions of...

Страница 38: ...n be adjusted in 5 levels Energy Saver after allows the user to select the duration until energy saving activities are enabled End of Treatment Sound allows the user to select 5 different type of EOT sound each with 4 additional signal beeps Sort Favorites when enabled will automatically sort the Favorites alphabetically Ultrasound Standard determines the ERA calculation model USA or IEC System In...

Страница 39: ...te the sponge pads with tap water Preferred is to use a saline solution instead because of the improved electrical conduction The supplied sponge pads have three layers With AC currents apply one sponge layer between the skin and the electrode for minimum resistance With DC currents apply two sponge layers between the skin and the electrode Two layers provide more absorbing capacity for electrolys...

Страница 40: ... start blinking and the treatment timer will stop counting down During this situation the applicator emits a small amount of energy to sense restoration of acoustical contact You may experience this when the ultrasound head only partially contacts the body When contact restoration is sensed the treatment is resumed at the set Amplitude Note The contact control function does not work at Amplitudes ...

Страница 41: ...lated and Russian Stimulation current waveforms multiply the electrode surface in cm by two For all other current waveforms the stimulator output current can never exceed 50 mA r m s This implies that with an electrode surface of 25 cm the current density can never exceed 2 mA r m s cm As a rule of thumb for smaller electrodes such as the 3 2mm self adhesives the maximum current setting available ...

Страница 42: ...etermines the current amplitude of the stimulation depends on the direction of the currents and can vary from 0 to 100 100 modulation depth only occurs at the diagonals and hence at the intersection of the two currents This is of course a theoretical situation based on the assumption that the tissue is homogeneous In reality the tissue is heterogeneous so that the current balance between the two c...

Страница 43: ...ally modulated in the vector modes Frequency modulation expressed in Hz defines a variable frequency range that is summed to the Beat frequency i e when the Beat frequency is set to 80 Hz and the Frequency modulation is set to 40 Hz the final frequency will vary from 80 120 Hz Frequency modulation is often used to prevent accommodation to stimulation or to improve patient tolerance Modulation prog...

Страница 44: ...d the burst rate can be adjusted separately With this milder TENS waveform it is easier to exceed the motorial threshold stimulus Parameters Phase Duration expressed in microseconds µs is the elapsed time from the beginning to the end of the initial pulse phase Pulse Frequency expressed in Hz or pps pulses per second defines the repetition rate of the TENS pulses Burst Frequency expressed in Hz de...

Страница 45: ...um carrier frequency for this purpose varies between 2000 4000 Hz At a low Beat frequency up to about 20 Hz the muscle becomes red while at a higher Beat frequency up to about 150 Hz the muscle becomes white This can be used to increase the explosive release of energy in high jumpers provided that is supplemented by functional exercises The most comfortable tetanic contractions are obtained at a B...

Страница 46: ...lternating polarity can be used to average out the DC component thereby reducing the formation of electrolysis by products Parameters Frequency expressed in Hz is the number of cycles per second Alternation mode defines whether the polarity of the wave is automatically alternating or not Alternation Period expressed in seconds defines the polarity reversal timing in the alternating mode Surge Prog...

Страница 47: ...efer to a monophase MF Monophasé Fixe or double phase DF Diphasé Fixe rectified alternating current The frequency was directly derived from the mains supply resulting in sinusoidal pulses with a duration of 10ms This phase time of 10ms will mainly depolarize thick fibers Stimulation of thin fibers can only be obtained at higher current amplitudes Bernard Pierre D La thérapie diadynamique Paris Edi...

Страница 48: ...rrent Faradic rectangular or triangular pulsed current Faradic currents are monophasic currents that produce electrolysis by products These by products can result in etching beneath the electrodes Always use properly moistened sponge electrode combinations to absorb these by products during treatment Faradic currents are often used for muscle stimulation applications that are based on prior diagno...

Страница 49: ...ent waveform and result in a pulse frequency of approximately 143 Hz Träbert offered no explanation for the choice of these parameters Nevertheless many specialists have adopted the therapy and it is still applied with success Träbert H Ultra Reizstrom ein neues therapeutisches Phänomen Elektromedizin 2 1957 7 Parameters Phase Duration expressed in milliseconds or seconds is the elapsed time from ...

Страница 50: ...uration fp Pulse frequency Asymmetrical alternating t Phase duration fp Pulse frequency Burst asymmetrical fB Burst frequency Burst asymmetrical alternating fB Burst frequency Symmetrical t Phase duration ti Phase interval fp Pulse frequency FIGURE 7 FIGURE 8 FIGURE 9 FIGURE 10 FIGURE 11 ...

Страница 51: ...frequency Faradic Current Träbert 2 5 current tp Phase duration 2 ms ti Phase interval 5 ms Rectangular pulsed current ms tp Phase duration ti Phase interval Rectangular pulsed current Hz tp Phase duration fp Pulse frequency FIGURE 12 FIGURE 13 FIGURE 14 FIGURE 15 ...

Страница 52: ... pulsed current Hz tp Phase duration fp Pulse frequency Galvanic current Galvanic interrupted f Carrier frequency 8 kHz fixed Duty cycle 90 fixed Galvanic continuous High voltage t Peak interval 64 µs fixed fp Pulse frequency Micro current f Frequency FIGURE 16 FIGURE 17 FIGURE 18 FIGURE 19 FIGURE 20 FIGURE 21 ...

Страница 53: ... of 72 EN109 1498751 47 IFU Diadynamic current MF FIGURE 22 DF FIGURE 23 LP FIGURE 24 CP FIGURE 25 CPid FIGURE 26 Modulation program Modulation program 1 1 fp Pulse frequency fm Frequency modulation FIGURE 27 ...

Страница 54: ... or 12 12 fp Pulse frequency fm Frequency modulation Modulation program 1 30 1 30 fp Pulse frequency fm Frequency modulation Surge program Surge program parameters tr Ramp up time th Hold time tf Ramp down time ti Interval time td Delay time FIGURE 28 FIGURE 29 FIGURE 30 ...

Страница 55: ...igh Voltage Faradic Current Faradic Rectangular or Triangular pulsed current These waveforms are often applied in combination with a surge program which consists of a sequence of exercise and rest periods Two options are available here Reciprocal application where stimulation alternates between agonists and antagonists This is accomplished through asynchronous stimulation over two current channels...

Страница 56: ...steps of 1s Interferential 4 polar Carrier Frequency 2 2 5 3 3 5 4 5 6 7 8 9 10 kHz Beat Frequency AMF 0 200 Hz in steps of 1 Hz Frequency Modulation spectrum 0 180 Hz in steps of 1 Hz Modulation program 1 1 6 6 12 12 1 30 1 30 s Amplitude 0 100 mA Isoplanar vector Carrier Frequency 2 2 5 3 3 5 4 5 6 7 8 9 10 kHz Beat Frequency AMF 0 200 Hz in steps of 1 Hz Frequency Modulation spectrum 0 180 Hz i...

Страница 57: ...in steps of 5 µs Pulse Frequency 1 200 Hz in steps of 1 Hz 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 1 1 6 6 12 12 1 30 1 30 s Surge Program Yes Amplitude 0 140 mA Burst Symmetrical Phase Duration 10 400 µs in st...

Страница 58: ... 12 1 30 1 30 s Alternating Period 10 100 seconds in steps of 10 s Ramp up ramp down 0 5 seconds Amplitude 0 500 Volt in steps of 1 Volt Micro Current Frequency 0 1000 Hz Polarity Positive or Negative Surge Program Yes Amplitude 10 µA 1 mA in steps of 10 µA Micro Current Alternating Frequency 0 1000 Hz 0 100 Hz in steps of 0 1 Hz 10 100 Hz in steps of 1 Hz 100 1000 Hz in steps of 10 Hz Alternating...

Страница 59: ...s in steps of 100 ms 1 5 seconds in steps of 1 second Surge program Yes Polarity Positive or Negative Amplitude 0 80 mA Faradic Rectangular Pulsed Current Hz Phase Duration 0 02 1000 ms Pulse Frequency 0 2 1 Hz in steps of 0 1 Hz 1 200 in steps of 1 Hz Surge Program Yes Polarity Positive or Negative Amplitude 0 80 mA Faradic Triangular Pulsed Current Hz Phase Duration 0 1 1000 ms Pulse Frequency 0...

Страница 60: ...ltrasound Power is the ultrasound output expressed in W The ultrasound output display can be toggled between W and W cm In pulsed mode the power during the pulse is displayed The time averaged power can be obtained by multiplying this value with the Duty Cycle Ultrasound Amplitude expressed in W cm is the quotient of Ultrasound Power and Effective Radiation Area The ultrasound output display can b...

Страница 61: ...e 80 0 2 5 W cm Duty cycle 100 0 2 W cm continuous wave Peak output power for 5 cm applicator Duty cycle 5 50 0 15 W Duty cycle 80 0 12 W Duty cycle 100 0 10 W continuous wave Peak output power for 0 8 cm applicator Duty cycle 5 50 0 2 4 W Duty cycle 80 0 2 W Duty cycle 100 0 1 6 W continuous wave Output meter uncertainty 20 for any output above 10 of maximum Pulse frequency 16 48 and 100 Hz 1 Dut...

Страница 62: ... distance from the applicator surface This field distribution applies to the radiation emitted into the equivalent of an infinite medium of distilled degassed water at 30 ºC and with line voltage variations in the range of 10 of the rated value The ultrasonic beam is characterized by the Effective Radiation Area ERA and the Beam Non uniformity Ratio BNR The Effective Radiation Area is the cross se...

Страница 63: ...ator and cable daily using lukewarm water The applicator can be disinfected using a cloth moistened with a 70 alcohol solution Check the applicator and cable regularly for damage Electrodes and accessories Between patient uses the rubber electrodes should be cleaned with lukewarm water To disinfect the electrodes or to remove stubborn stains of dirt use a 70 alcohol solution The alcohol solution c...

Страница 64: ...e any further operation or use of the system Use of a device that indicates an error or warning may pose a risk of injury to the patient user or extensive internal damage to the system In case of display failure or other obvious defects unplug the device immediately and notify a certified service technician Patient circuit interrupted There is insufficient or no output current available at the out...

Страница 65: ... with caution The intensity you have set is above the recommended maximum When increasing the dosage of a StatUS device above the recommended maximum of 1 5W cm2 this notification is shown Operator should proceed with caution StatUS applicator error The StatUS applicator has reported an error Disconnect the device wait some time and reconnect it If the error persists stop using the device and cont...

Страница 66: ...of the device while operating on battery power Firmware upgrades are only allowed when operating on mains power Maintenance Optimize contact control ultrasound applicator When you experience difficulties with the contact control function of the ultrasound applicator you can try to resolve the problem as follows Ensure that the surface of the ultrasound applicator is clean and dry Place the ultraso...

Страница 67: ...personnel to repair those parts of the equipment which are designated by the manufacturer as repairable All other technical maintenance is restricted to authorized Enraf Nonius maintenance personnel Authorized service personnel can make use of 1498 770 Service manual 4 series Firmware update If your system requires a Firmware Update contact your supplier to obtain a USB stick containing the latest...

Страница 68: ...ndards Medical device classification IIa Rule 9 Annex IX of 93 42 EEC This equipment complies with all requirements of the Medical Device Directive 93 42 EEC IEC 60601 1 General requirements for the safety of electrical medical systems including Annex I national differences for Australia Canada and the United States IEC 60601 2 5 Particular requirements for the safety of ultrasonic therapy equipme...

Страница 69: ...ries should only be operated with the original power cable specified in the list of contents delivered Operating the device with any other power cable can lead to increased emissions or reduced interference immunity of the device Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment ...

Страница 70: ... to use the product including without limitation damages for loss of goodwill work and productivity computer failure or malfunction or any and all other commercial damages or losses even if advised of the possibility thereof and regardless of the legal or equitable theory contract tort or otherwise upon which the claim is based In any case Enraf Nonius entire liability under any provision of this ...

Страница 71: ...Page 71 of 72 EN109 1498751 47 IFU ...

Страница 72: ...EN109 1498751 47 Copyright Enraf Nonius B V Vareseweg 127 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 info enraf nonius nl ...

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