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Contents

Scope of Delivery, Accessories

17.1 Soleo SonoStim

17.2 Soleo Galva

17.3 VacoS

Device Combinations

Safety and Maintenance

Function Test

Legal Notices

Error Message, Troubleshooting, Disposal

Manufacturer's EMC Declaration

Valid for devices Soleo SonoStim, Soleo Galva and VacoS.

These instructions for use are an integral part of the device.

It must be stored with the device and kept accessable at all times for anyone to

operate this device.

The instructions for use are valid from August 2016.

Содержание Soleo SonoStim

Страница 1: ...Instructions for Use Soleoline Soleo SonoStim Soleo Galva Soleo VacoS EN...

Страница 2: ......

Страница 3: ...ront panel Fig 1 Device and operating elements 1 Intensity controller channel I 2 Intensity controller channel II 3 Alligator clips clipping options 4 Tray mount for ultrasound head 5 Display 6 Touch...

Страница 4: ...rs Fig 3 Navigation bar Description of functions A Back Moves back one step B Memory Switches to the memory area C Indications Switches to the indication menu D Programmes Switches to the programme li...

Страница 5: ...Switches and connector sockets 12 On off switch 13 Holder for mains fuse 14 Connection for mains cable 16 Socket for electrode cable channel II 17 Connector for ultrasound head 0 8 2 4 MHz 18 Socket f...

Страница 6: ...anel sockets Fig 5 Ports Group 1 19 Socket for Vaco electrode tube black cathode 20 Socket for Vaco electrode tube red anode Group 2 21 Socket for Vaco electrode tube black cathode 22 Socket for Vaco...

Страница 7: ...25 Connection for mains cable 26 Bracket for mains backup 27 Socket for electrode cable channel II 28 Socket for connection cable with SonoStim Galva channel II 29 Socket for electrode cable channel I...

Страница 8: ...Explanation of Symbols Soleo SonoStim Soleo Galva VacoS Side view Fig 8 Connections 33 Water separator connector valve 33...

Страница 9: ...Explanation of Symbols Soleo SonoStim Soleo Galva Ultrasound heads Fig 9 Ultrasound head large Ultrasound head small...

Страница 10: ...n the instructions for use this symbol represents Caution with regard to damage of the device Device Type BF Follow the instructions for use Instructions for Use Serial number Item number Manufacturer...

Страница 11: ...s Page 1 Indications Contraindications 1 1 Electrotherapy indications 1 2 Electrotherapy contraindications 1 3 Ultrasound therapy indications 1 4 Ultrasound therapy contraindications 1 3 4 5 2 Side Ef...

Страница 12: ...coS 11 2 Water separator VacoS 11 3 SD card 11 4 Menu indications 11 5 Storing Programmes 11 6 Retrieving programmes Editing the list 11 7 Programme sequence 38 41 42 43 45 47 49 12 Paralysis Diagnosi...

Страница 13: ...21 Legal Notices 74 22 Error Message Troubleshooting Disposal 75 23 Manufacturer s EMC Declaration 79 Valid for devices Soleo SonoStim Soleo Galva and VacoS These instructions for use are an integral...

Страница 14: ...dromes with spinal disorders subacute and chronic Ligament ruptures Tenosynovitis Bursitis Analgesic therapy Sprains contusions muscle sprains Tendons joints and bones Large myalgia Polyarthralgia Joi...

Страница 15: ...ronic Disease in the peripheral joints acute subacute Post traumatic state images hematoma edema Excessive sweating of hands and feet hyperhidrosis palmarum and plantarum Spinal disorders acquired pos...

Страница 16: ...py Causally repairable pain Predominantly psychogenic pain TENS therapy is ineffective Central pain syndromes for example thalamic pain syndrome In addition the following contraindications should be o...

Страница 17: ...indicated Arthrosis Periarthropathies Epicondylopathy Tendopathies periostosis calcaneal spurs Achillodynia Scars contractures Dupuytren s contracture Posttraumatic arthritis Fractures particularly i...

Страница 18: ...rtebrae do not use ultrasound higher than C 3 Ultrasound treatment of parenchymatous or heat sensitive organs testes eyes gravid uterus liver kidneys etc Anaesthetised skin areas Temperature sensitivi...

Страница 19: ...Side Effects 2 Page 6 Side effects of electrotherapy If used correctly no side effects are known Side effects of ultrasound therapy If used correctly no side effects are known...

Страница 20: ...e Therefore the device must not be operated in the vicinity of devices that generate strong electromagnetic fields X ray or diathermy devices MRI scanners Please keep a safe distance of several metres...

Страница 21: ...exceeds 2 mA eff cm an increased attention from the user is required Note that with a smaller electrode surface a higher current density is achieved by using different electrodes Caution The Tens trea...

Страница 22: ...damage prior to each use If damaged it must not be used Caution In simultaneous operation the ultrasonic head may be used as the dynamic electrode in connection with a stationary electrode which is co...

Страница 23: ...structions are followed Use in wet areas is not permitted and non compliance may lead to considerable damage and endanger both the patient and the user Dispose of the packaging material correctly Keep...

Страница 24: ...ritation or hypersensitivity in susceptible patients This can be reduced by the use of alternative electrode material or by changing the electrode system Stimulation should not be used above the sinus...

Страница 25: ...ltrasound Why use Soleoline A modern clearly arranged colour display that provides all therapy related parameters as well as modern touch operation Customisable program start up settings and a clear s...

Страница 26: ...asound therapy device for treatment with therapeutic ultrasound Soleo SonoStim Combination device for ultrasonic therapeutic treatment and electrotherapy with the option of the additional use of a vac...

Страница 27: ...ctor of the electrode cable Insert the black alligator clips to the black connector of the electrode cable Ultrasound therapy Connect the ultrasound head to the appropriate socket 17 Connect the mains...

Страница 28: ...ug below Channel I Connect the connecting cable to the intended port on Soleo SonoStim Soleo Galva 18 and on VacoS 30 Channel II Connect the connecting cable to the intended port on Soleo SonoStim Sol...

Страница 29: ...e socket 4 on the front of VacoS at II Insert the Vaco electrode to the connector on the free end of the Vaco electrode hose Assembly Vaco electrodes Connect each of the 4 Vaco electrode hoses to each...

Страница 30: ...de from the start up screen start up Screen Once the device has been switched on and the self test performed the start up screen opens or Selecting configuration Touching the button opens the configur...

Страница 31: ...as shown in the screen Language Selecting the language The selection is made directly in the corresponding row Program start up settings Adjustment of the program start up settings The selection is m...

Страница 32: ...s Brightness Adjustment of screen brightness from 0 to 10 The adjustment is made using the two arrow keys Screensaver Adjustment of screen saver start time from 0 20 minutes The adjustment is made usi...

Страница 33: ...neral 8 Page 20 Set Defaults Touching button restores the default factory settings Version Touching the button opens a window with information regarding the current software version Touch the OK butto...

Страница 34: ...for all programmes The adjustment is made using the two arrow keys Polarity reversal cycle Adjustment of periods of time from 10 to 120 seconds The adjustment is made using the two arrow keys Frequen...

Страница 35: ...settings are only active in the Soleo SonoStim version Ultrasound therapy settings Coupling signal Adjustment 50 to 95 of the coupling limits value The adjustment is made using the two arrow keys Uni...

Страница 36: ...the Maintenance Configuration Selection screen In the maintenance menu software updates can be performed You will receive the latest information about performing a software update when an update is pl...

Страница 37: ...ram start up Touching button opens the programme screen Here the desired programme may be selected SonoStim programme In SonoStim 3 different forms of treatment are available Selecting electrotherapy...

Страница 38: ...n 9 1 Electrotherapy 9 Page 25 Current form configuration The current form selection is made directly in the corresponding row here NF 00 Therapy screen After selection of the current form the therapy...

Страница 39: ...time counts down at one second intervals End of therapy The end of the treatment period is indicated by an acoustic signal at the end of treatment the clock is set to 00 00 the intensity automaticall...

Страница 40: ...screen Note If there is no vacuum unit connected this button is completely hidden 4 Channel After activating the button several channel mode selection possibilities are available In group mode you ca...

Страница 41: ...is no threshold activated the threshold window is shown minimised Activation of the threshold button opens the threshold parameters window Here threshold can be activated or the parameters can be use...

Страница 42: ...tton opens the programme screen Here the desired programme may be selected Selecting ultrasound therapy The ultrasound therapy selection is made directly in the corresponding row Programme selection T...

Страница 43: ...case 5 cm corresponds with the connected ultrasound head Adjusting the intensity Adjust the intensity using the left intensity controller Therapy startup Touching starts the therapy When therapy star...

Страница 44: ...nals the end of therapy and the clock reads 00 00 The intensity automatically returns to zero the bar graph display disappears and the coupling indicator is inactive The display in the lower status ba...

Страница 45: ...information regarding the current therapy status If therapy is not active the Ready display appears When therapy is in progress the text Active appears 5 Title bar In the title bar the name of the cur...

Страница 46: ...touching the water bath button and confirming with OK the temperature monitoring of the ultrasound head is modified to suit water bath therapy Note Upon completion of water bath therapy it is possible...

Страница 47: ...ng the button opens the programme screen Here the desired programme may be selected Selecting simultaneous therapy The simultaneous therapy selection is made directly in the corresponding row Programm...

Страница 48: ...intensity over the right intensity controller simultaneous therapy is active Adjusting electrical stimulation intensity The display in the lower status bar changes from ready to active In the left bar...

Страница 49: ...e clock reads 00 00 The intensity automatically returns to zero the bar graph display disappears and the coupling indicator is inactive The display in the lower status bar changes from Active to Ready...

Страница 50: ...n opens the electrotherapy programme window Selecting the current form group The selection of the desired current category is carried out directly in the corresponding row rectangular monophasic curre...

Страница 51: ...ng the vacuum menu Clicking on the button opens the vacuum menu Activating the basic vacuum A basic vacuum of 16 kPa is set at the factory Pressing the button activates the basic vacuum for sucking th...

Страница 52: ...d and the therapy time counts down at one second intervals Electrophysiology therapy end The end of the treatment period is indicated by an acoustic signal at the end of treatment the clock is set to...

Страница 53: ...tarts and stops the suction of the electrodes with the basic vacuum 2 Mode Activation of the button opens the vacuum entry field for setting the parameters 3 Working vacuum The working vacuum can be a...

Страница 54: ...ater separator that collects the moisture released from the sponges and thereby protects the vacuum unit from calcification If the water separator is full a message appears on the display empty water...

Страница 55: ...42 SD card Custom settings and the list of indications are saved on the SD card Note If the SD card is not inserted the message No SD card found will appear when you press the Indications Favourites...

Страница 56: ...selecting the desired region of the body here shoulder an indications window opens with various disorders in the shoulder area The symptom is selected directly in the respective row in this case shou...

Страница 57: ...11 Page 44 Therapy information After selecting the differentiated clinical picture another window opens with detailed therapy information and a program recommendation Selecting the therapy program Tou...

Страница 58: ...utton opens the keyboard to enable the entry of the programme name There are 2 available options for the programme name 1 Acceptance of the program name from the input field 2 Entry of a personal prog...

Страница 59: ...es list and automatically saves the program in the favourites list Pressing button 2 opens the memory list and saves the program in the memory list Touching the OK button closes the Save screen and mo...

Страница 60: ...e and editing the favourites memory list are identical therefore only the retrieve and editing of the favourites list is described Selecting the favourites list Touching button opens the favourites li...

Страница 61: ...esponding row Touching button 1 returns you to the favourites list Touching button 2 scrolls the program up Touching button 3 scrolls the program down Touching button 4 deletes the program Note Touchi...

Страница 62: ...the intensity levels for individual sequences are set in advance of the therapy Activating the sequence window By activating field this opens the sequences window Here the intensity thresholds of the...

Страница 63: ...ce 11 Page 50 Therapy startup Activation of button starts the therapy The 3 sequences take place in succession The sequence change is indicated by an acoustic signal End of therapy After the treatment...

Страница 64: ...rogrammes PA 00 Medium frequency innervation test according to Lange PA 01 Faradic test PA 02 Chronaxie accomodation quotient PA 15 Gold standard test For therapy different programmes are available wi...

Страница 65: ...screen Note When using full intensity the pulse button is active Performance Turn on at an appropriate intensity and activating the button triggers a single pulse Subsequently the test is carried out...

Страница 66: ...ated normally A muscle is normally innervated when it reacts during a stimulation time of 1 minute with an equally long lasting contraction Innervation is to be assumed if no or only short term contra...

Страница 67: ...um muscle twitch is visible With the first minimal muscle twitch the rheobase value is determined Step 3 Accepting the rheobase value With the acquisition of the detected pulse the intensity is automa...

Страница 68: ...ar impulse response RIC Rectangular impulse response Identifying assuming the accomodation threshold Step 1 Set to a low intensity Step 2 Trigger a single pulse Repeat steps 1 and 2 with increasing in...

Страница 69: ...full degeneration Normal chronaxie value according to Edel Anterior muscles front of the body Proximal 0 08 to 0 16 ms Distal 0 16 to 0 32 ms Posterior muscles back of the body Proximal 0 16 to 0 32...

Страница 70: ...ulse of 100 ms As a result the quotient FGQ I1 I2 is shown Display screen Performing measurement phase 1 Step 1 Turn on adequate intensity Step 2 Trigger a single pulse Repeat steps 1 and 2 with incre...

Страница 71: ...d therapy 12 5 Fisch Gold Test 12 Page 58 Assessment of the quotients 1 7 normally functioning neuromuscular system 1 7 partial degeneration Should one of the two intensities not be determined the deg...

Страница 72: ...ting mode Intermittent operation 30 minutes on 10 minutes off Applied Part Type BF Dimensions 322mm x 234mm x 130mm Weight 2 1 kg Operation 10 C to 35 C 20 to 80 relative humidity without condensation...

Страница 73: ...peak 200 Vpeak Medium frequency currents MF xx CC 56 mA 56 mA 56 mA 56 mA CV 10 V 25 V 60 V 60 V Interferential currents IF xx CC 56 mA 56 mA 56 mA 56 mA CV V V V V Micro stimulation currents MI xx CC...

Страница 74: ...us 0 1 ms Medium frequency currents MF xx MF 80 mApeak 8000 3 200 Hz 80 Vpeak 1 ms 50 ms Interferential currents IF xx IF 100 mApeak 8000 10 120 Hz 125 us 0 4 s Micro stimulation currents MI xx MI 2...

Страница 75: ...0 1 W cm Ultrasound head large 5 cm ERA 2 30 cm at 0 8 MHz 2 38 cm at 2 4 MHz Maximum power 6 9 W at 0 8 MHz 7 1 W at 2 4 MHz Intensity levels 0 1 to 3 W cm eff at intervals of 0 1 W cm Accuracy 20 S...

Страница 76: ...tes on 10 minutes off Dimensions 322mm x 234mm x 130mm Weight 3 0 kg Operation 10 C to 35 C 20 to 80 relative humidity without condensation 700 hPa 1060 hPa Storage and transport 10 C to 50 C 10 to 90...

Страница 77: ...agents designed for plastics Wipe the surface until the dirt is removed using a soft cloth soaked according to the specifications of the manufacturer of the cleaning agent so it is not dripping Disin...

Страница 78: ...tructions of the manufacturer Dip the Vaco electrodes fully in the disinfectant and move around a little Make sure that the inner and outer surface is completely covered with disinfectant If applicabl...

Страница 79: ...eated use of the disposable electrode can be dangerous for the patient For particularly large scale applications in addition to the disposable electrodes plate and rubber electrodes are also available...

Страница 80: ...he products bear the CE marking in accordance with EC Directive 93 42 EEC concerning medical devices Manufacturer Zimmer MedizinSystems GmbH Junkersstra e 9 89231 Neu Ulm Germany Tel 49 731 9761 291 F...

Страница 81: ...ectrode cables with twist protection and magnetic clip 2 90 m long 31100146 Alligator clip red 31100147 Alligator clip black 87200120 Box single use electrodes small 32 x 40 mm 200 pairs 87200140 Box...

Страница 82: ...netic clip 2 90 m long 31100146 Alligator clip red 31100147 Alligator clip black 87200120 Box single use electrodes small 32 x 40 mm 200 pairs 87200140 Box single use electrodes medium 56 x 56 mm 100...

Страница 83: ...tim Soleo Galva 1 mains connection cable 50 cm 4 pieces sorting combs for Vaco lines incl magnetic clip 1 water bottle Accessories Art No 95 Sponge for Vaco electrode large for 72 94 Sponge for Vaco e...

Страница 84: ...Combinations 18 Page 71 Soleo SonoStim and Soleo Galva can be used with VacoS If you combine the devices and therefore operate a medical system you are solely responsible for the accuracy of the conn...

Страница 85: ...are inspected for any damage that may affect the safety of the device e g cracks prior to use the equipment is only operated by properly trained personnel the device is immediately disconnected from...

Страница 86: ...ay in the bar graph must be full Run the test with both channels one after the other Ultrasound Select the ultrasound head and cover the ultrasound head surface with coupling gel In the case of starti...

Страница 87: ...e measures stipulated therein The devices are not listed in Annex 2 of MPBetreibV Medical Device Operating Directive In Germany the DGUV regulation 3 Electrical Systems and Equipment in its current ve...

Страница 88: ...t This refers to an increase in the maximum allowable current An indicated increase in current in constant operation usually indicates a fault in the device while increasing the current in constant vo...

Страница 89: ...cuum button disabled Should the vacuum button be disabled a transmission error may be present Check the following in this case whether Soleo SonoStim Soleo Galva is connected correctly to VacoS whethe...

Страница 90: ...e 33 for draining the water separator is on the right side of VacoS On the water bottle hose there is a quick release lock which is connected to the connection valve on the device Empty the water Sque...

Страница 91: ...the service via your assigned sales representative or our headquarters in Neu Ulm The device must be returned to the factory in its original packaging For questions or equipment malfunctions please co...

Страница 92: ...r of the Soleo SonoStim Soleo Galva must ensure that it is operated in such an environment Emissions measurements Compliance Electromagnetic environment guidelines RF emissions in accordance with CISP...

Страница 93: ...dance with IEC 6100 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode The supply voltage quality must correspond to that of a typical commercial or hospital environme...

Страница 94: ...z to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 VRMS 150 kHz to 80 MHz 10 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should not be used any closer to the Soleo SonoStim Soneo Galva in...

Страница 95: ...ntended for use in an electromagnetic environment in which RF disturbances are controlled The customer or the user of the Soleo SonoStim Soleo Galva device can thus help to prevent electromagnetic int...

Страница 96: ...0317 I Version 3 I Right of modification reserved Soleoline Zimmer MedizinSysteme GmbH Junkersstra e 9 D 89231 Neu Ulm Tel 49 7 31 97 61 291 Fax 49 7 31 97 61 299 export zimmer de www zimmer de Instr...

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