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117

CE Marking

The products bear the CE marking

in accordance with EU Medical Devices Directive 93/42/EEC and meets the
essential requirements of Annex I to this Directive.

The product Soleo

SonoStim

is rated in Class IIb according to Annex IX of

the Directive.

The product Soleo

Galva

is rated in Class IIa according to Annex IX of the

Directive.

The product Vaco

is rated in Class IIa according to Annex IX of the

Directive.

Soleo

SonoStim

/ Soleo

Galva

/ Vaco

have been developed, manufactured

and tested under the ISO 13485 quality management system.

Содержание Soleo SonoStim

Страница 1: ...Operating Instructions Soleoline Soleo SonoStim Soleo Galva Soleo VacoS GB...

Страница 2: ......

Страница 3: ...s 1 Intensity controller channel I 5 Screen 2 Intensity controller channel II 6 Touch pen in holder 3 Alligator clip option 7 SD card slot 4 Slot for ultrasound head Fig 2 Screen readouts 8 Status bar...

Страница 4: ...or sockets 12 Connector for mains cable 16 Socket for electrode cable channel II 13 Fuse drawer for mains fuse 17 Socket for 0 8 2 4 MHz ultrasound head 14 On off switch 18 Socket for electrode cable...

Страница 5: ...kets Circuit I 1 Connector socket Vaco electrode sleeve black cathode 2 Connector socket Vaco electrode sleeve red anode Circuit II 3 Connector socket Vaco electrode sleeve black cathode 4 Connector s...

Страница 6: ...cable Channel II 6 Connector for mains connector cable 10 Socket for connecting cable with SonoStim I Galva channel II 7 Connector for mains cable 11 Socket for electrode cable channel I 8 Fuse holde...

Страница 7: ...Soleo SonoStim Soleo Galva and VacoS Side view Fig 6 13 Connector valve for water separator 13...

Страница 8: ...ry 1 2 Fitting the cables starting the system 2 1 Soleo SonoStim Soleo Galva 2 2 2 VacoS 3 3 Configuration 3 1 General 6 3 2 Electrotherapy 12 3 3 Ultrasound therapy 14 3 4 Maintenance 16 4 Soleo Sono...

Страница 9: ...2 2 Description of the parameter button 63 12 3 Description of the treatment depth button 66 13 Combination therapy Screenshot of the therapy screen 67 14 Electrotherapy with VacoS Screenshot of the t...

Страница 10: ...electrode types 115 29 CE Marking 117 30 Contents on delivery accessories 30 1 Soleo SonoStim 118 30 2 Soleo Galva 119 30 3 VacoS 120 31 Device combinations 121 32 Safety and maintenance 122 33 Funct...

Страница 11: ...ges of Soleoline A clear contemporary colour screen showing all parameters necessary for therapy as well as modern touch control Individual programme start configuration and clear simple menu navigati...

Страница 12: ...II into the appropriate socket 16 Attach the red alligator clip to the red connector on the electrode cable Attach the black alligator clip to the black connector on the electrode cable Ultrasound the...

Страница 13: ...he device Fig 4 Connecting VacoS with SonoStim Galva When fitting the connection cable ensure that the green arrow is pointing downwards when connecting the cable to Soleo SonoStim Soleo Galva 18 When...

Страница 14: ...te socket 9 on VacoS Attach the red alligator clip to the red connector on the electrode cable Attach the black alligator clip to the black connector on the electrode cable Installation of Vaco electr...

Страница 15: ...appropriate sockets on VacoS 6 and Soleo SonoStim Soleo Galva 12 Connecting the mains cable Plug the mains cable into the appropriate socket on VacoS 7 and then plug the cable into the mains power wal...

Страница 16: ...single channel and are based on the factory default settings Note Changes to the default settings can only be made from the start screen Start screen After switching on the device and the self test t...

Страница 17: ...ive Saving settings Press the button to save the new settings Quitting the configuration menu Press the button to return to the start screen General settings The setting options are outlined below In...

Страница 18: ...open the drop down menu to select the programme start configurations The options are selected by pressing on the appropriate row Start screen Option to choose between 2 start screens Press the arrow...

Страница 19: ...itch sound on and off The selection is made by pressing on the appropriate row Volume Option to adjust the volume in steps from 1 to 4 Press the arrow key to open the window to adjust the volume The v...

Страница 20: ...after 0 to 20 minutes The time is selected using both arrow keys Note While therapy is running the screen saver function is deactivated Welcome message Option to configure an individual welcome messa...

Страница 21: ...General 3 Setting defaults Press the button to reset the factory standard settings Version Press the button to open the window with information about the current software version Press the OK button...

Страница 22: ...tion screen The settings required for therapy can be adjusted here Time Option to configure a uniform therapy time of 1 to 60 minutes for all programmes The time is selected using both arrow keys Pola...

Страница 23: ...and 8000 Hz The frequency is selected using both arrow keys Note The device is preset with a base frequency of 8000 Hz If you modify the base frequency in this menu the name of programmes MF00 to MF1...

Страница 24: ...s is only possible in the Soleo SonoStim version Ultrasound therapy settings Press the menu to open the Ultrasound therapy configuration screen The settings required for therapy can be adjusted here C...

Страница 25: ...asound therapy 3 Units Option to configure the units for intensity in a bar graph Press the arrow button to open the drop down menu to select the desired units for power The unit is selected by pressi...

Страница 26: ...oard to insert the password To open the update menu enter the password armin Software can be updated using the updates menu You will receive the latest information about updating software when an upda...

Страница 27: ...ing the therapy time can result in a modification of the effects and the patient must be carefully monitored during treatment Starting the programme Press the button to open the Programme screen The p...

Страница 28: ...g electrotherapy Electrotherapy is selected by pressing on the appropriate row The following description refers to the electrotherapy programme Selecting current forms group Select the current forms g...

Страница 29: ...ng instructions 4 1 Electrotherapy 4 Selecting current form Select the current form by pressing on the appropriate row here LF 00 Therapy screen After selecting the current form the therapy screen ope...

Страница 30: ...apy time counts down in seconds Ending therapy At the end of the therapy time an acoustic signal indicates that the therapy has ended the clock is reset to 00 00 the intensity automatically returns to...

Страница 31: ...instructions 4 2 Ultrasound therapy 4 Starting the programme Press the button to open the Programme screen The programme is selected here Selecting ultrasound therapy Ultrasound therapy is selected b...

Страница 32: ...desired ultrasound therapy programme by pressing on the appropriate row here US 01 Therapy screen After selecting the ultrasound therapy programme the therapy screen opens Note Check that the informat...

Страница 33: ...sity controller on the left Starting therapy Press the button to start the therapy The display in the bottom status bar changes from Ready to Active with the start of therapy and the Start button chan...

Страница 34: ...es that the therapy has ended and the clock is reset to 00 00 The intensity automatically returns to zero the bar graph display disappears and the coupling display is inactive The display in the botto...

Страница 35: ...ultrasound head temperature monitoring must be changed before starting the therapy Implementation Press the Parameters button to open the Ultrasound Parameters window Pressing Water bath button By pr...

Страница 36: ...automatically deactivated Continuing therapy in the water bath Press the button Ending therapy in the water bath Press the button Note Once therapy in the water bath is complete the temperature of th...

Страница 37: ...g instructions 4 3 Combination therapy 4 Starting the programme Press the button to open the Programme screen The programme is selected here Selecting combination therapy Select combination therapy by...

Страница 38: ...instructions 4 3 Combination therapy 4 Selecting the programme Select the desired combination therapy programme by pressing on the appropriate row Therapy screen After selecting the combined therapy p...

Страница 39: ...ler on the right Setting intensity of stimulation current The display in the bottom status bar changes from Ready to Active In the left bar graph the adjusted ultrasound dose is shown and the coupling...

Страница 40: ...stic signal indicates that the therapy has ended and the clock is reset to 00 00 The intensity automatically returns to zero the bar graph display disappears and the coupling display is inactive The d...

Страница 41: ...the button to open the Programme screen Selecting current forms group Select the current forms group by pressing on the appropriate row here monophasic rectangular current Note The additional steps re...

Страница 42: ...s analogous to that described in Section 4 1 Electrotherapy Note If a vacuum unit is not attached the Vacuum button is not displayed This is also the case if data transmission or the connection of the...

Страница 43: ...odes By activating the base vacuum the vacuum is active In the bar graph the value of the base vacuum is shown Note The factory setting is continuous mode Press the Mode button to open the input windo...

Страница 44: ...herapy starts The effective current is shown in the bar graph and the therapy time counts down in seconds Ending electrotherapy At the end of the therapy time an acoustic signal indicates that the the...

Страница 45: ...Quick operating instructions Electrotherapy with VacoS 6 Note The vacuum must be ended manually using Stop after expiry of the time The Stop button changes to Start Deactivating the vacuum Deactivate...

Страница 46: ...age Empty water separator appears on the screen If the water separator is not emptied therapy cannot be started Empty the water separator as described in Section 35 SD card User defined settings and t...

Страница 47: ...ss the button to open the settings menu The options are described in detail in Section 3 Start Press the button to open the start screen from the Programme window Favourites Press the button to open F...

Страница 48: ...tton to open the channel mode When the button is pressed different channel mode options can be selected Mode Group Activates Monostim 1 channel therapy The exceptions are pre programmed dual channel c...

Страница 49: ...defined here for the Twinstim and Duostim modes Alternate activation The current forms are started and stopped simultaneously on both channels The surges are alternate Parallel activation The current...

Страница 50: ...Both buttons are highlighted in channel mode and can only be activated in Duostim mode Saving Press the button to open the screen to save a programme The Save button can only be pressed from the ther...

Страница 51: ...y one position Moving Press the button to move the order of the list downwards by one position Deleting Press the button to delete the selected programme from the list Scrolling forwards Press the but...

Страница 52: ...s 8 Close Press the button to close the Favourites and Memory programmes Cancel Press the button to reject the changes made OK Press the button to confirm the changes in the selected list OK The chang...

Страница 53: ...43 Electrotherapy Screenshots of the various therapy screens 9 Monostim Example Programme LF00 on one channel I Twinstim Example Programme LF00 on both channels I and II...

Страница 54: ...44 Electrotherapy Screenshots of the various therapy screens 9 Duostim alternating Duostim parallel Duostim separate...

Страница 55: ...s bar The status bar shows information on the current status of the therapy If the therapy is not active it shows the word Ready During therapy it shows the word Active Effects Gives an overview of th...

Страница 56: ...raph of intensity Shows the currently specified intensity In CC mode display in mA eff or peak In CV mode display in V peak Vacuum 1 Indicates on the therapy screen that the vacuum unit is connected 2...

Страница 57: ...10 4 1 1 Frequency display 1 2 Graphic view of waveform 1 3 Polarity 1 4 CC CV 1 5 Galvanic component Note Modes 1 3 1 5 cannot be used with all current forms and are therefore not always displayed 1...

Страница 58: ...negative polarity reverses automatically Note If the polarity reverses automatically the first polarity reversal is for 45 seconds factory setting or the time set in the configuration menu 1 4 CC CV...

Страница 59: ...see Section 10 5 Note If the Surge icon is activated during therapy the therapy will be interrupted and the intensity will be set to zero The therapy time is stopped The therapy is restarted for the...

Страница 60: ...herapy the surge is shown as an animation showing the surge position Synchronisation mode alternated Alternating In two channel mode the alternating surge mode is shown by the two opposing arrows in t...

Страница 61: ...o zero and the therapy time is set to the standard value Activating the Parameters button When the Parameters button is activated the Parameters of Current Form window is opened Parameters of current...

Страница 62: ...changed are selected with the arrow keys The parameter highlighted in blue can be changed impulse time here Note Changes to the pulse and pulse hold time also change the frequency Changing parameters...

Страница 63: ...ent or to eliminate the galvanic component Switching CC CV mode Press the arrow keys to switch the current form from CC to CV mode and vice versa Changing polarity Press the arrow keys to change the p...

Страница 64: ...54 Electrotherapy 10 4 Change current form parameters 10 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes...

Страница 65: ...ard value Activating Surge button When the Surge button is activated the Surge Parameters window is opened Surge parameters The surge parameters can be modified as follows by the user Surge rise time...

Страница 66: ...ime Selecting parameters Select the parameters to be changed using the arrow keys 1 Rise time 1 5 s here 2 Hold time 4 0 s here 3 Pause time 12 s here The parameter highlighted in blue can be changed...

Страница 67: ...57 Electrotherapy 10 5 Change surge parameters 10 Saving parameters Press the button to save the modified parameters Cancelling changes Press the button to reject changes...

Страница 68: ...ameters window is activated the Parameters of Current Form window is opened Parameters of current form Adjustable parameters can be changed by the user here 1 Base frequency 4000 Hz here and modulatio...

Страница 69: ...59 Ultrasound therapy Screenshot of the therapy screen 11...

Страница 70: ...rmation on the current status of the therapy If the therapy is not active it shows the word Ready During therapy it shows the word Active Parameters 1 Displays data from the connected ultrasound head...

Страница 71: ...here 1 2 Operating mode Pulse ratio Pulse frequency Graphic view of the operating mode continuous or pulsed Pulsed operating mode showing the pulse ratio 1 3 here and the pulse frequency 50 Hz here De...

Страница 72: ...percentage The most beneficial coupling value is 100 If the coupling is below the preset value factory setting 75 an acoustic signal sounds and the therapy time is paused In this case Set a new coupli...

Страница 73: ...o zero and the therapy time is set to the standard value Note Only the parameters that are shown in the parameter window can be changed Activating the parameter button When the Parameter window is act...

Страница 74: ...select the desired mode Modes continuous pulsed with duty cycles of 1 2 1 3 1 5 and 1 10 Selecting the frequency Press the two arrow buttons to select the desired frequency Frequencies 20 Hz 50 Hz and...

Страница 75: ...65 Ultrasound therapy 12 2 Description of the parameter button 12 Saving Press the button to save the modified parameters Cancelling changes Press the button to reject changes made...

Страница 76: ...is activated during therapy the therapy will be interrupted the intensity returns to zero and the therapy time is set to the standard value Adjusting treatment depth Press the Depth of treatment butt...

Страница 77: ...ote The buttons and functions on the Combination therapy screen correspond exactly to the therapy screens for Electrostimulation and Ultrasound therapy as described in the previous sections An extensi...

Страница 78: ...have been described in detail in the preceding sections and only the displays and buttons that are also active when using VacoS will be described in this section Electrotherapy combined with VacoS No...

Страница 79: ...t displayed This is also the case if data transmission or the connection of the vacuum unit to SonoStim Soleo Galva is broken or interrupted Parameters The display shows the parameters of the factory...

Страница 80: ...Changing vacuum parameters Press the button to open the vacuum menu to set the vacuum parameters Continuous mode The factory setting is continuous mode Pulse mode Adjust the pulse duration using both...

Страница 81: ...e base vacuum using the arrow keys to the left and right of the Base Vacuum window Note If the base vacuum is set higher than 16 kPa the vacuum must be increased first An increase in the base vacuum a...

Страница 82: ...2 Changing parameters 14 Saving parameters Press the button to save the changed parameters and to return to the Vacuum start screen Cancelling changes Press the button to reject the changes and to re...

Страница 83: ...Indications menu 15 The Indications menu helps you to select the therapy Indications Press the button to open the Indications menu Selecting by body region Select a body region by touching a blue circ...

Страница 84: ...owing various symptoms in the shoulder region Select the symptoms by clicking on the relevant row shoulder arm syndrome in this example Selecting by detailed symptoms After selecting the symptoms anot...

Страница 85: ...information After selecting the detailed symptoms another window opens showing detailed therapy information and a suggested programme Selecting the therapy programme Press the button to open the ther...

Страница 86: ...me parameters can be separately modified and saved Note The procedure for saving is similar for all therapy forms The save procedure for an electrotherapy programme is described below Selecting the pr...

Страница 87: ...name Naming the programme Two options are available for naming a programme 1 Accept the programme name in the input field 2 Enter a custom programme name If using a custom name use the keyboard to en...

Страница 88: ...gramme in Favourites Press the button to open Favourites Adding the programme to Favourites Press the button to add the programme to Favourites The programme is automatically saved in the first free s...

Страница 89: ...ogramme in the Memory Press the button to open the Memory Adding the programme to the Memory Press the button to add the program to the Memory The programme is automatically saved in the first free sp...

Страница 90: ...e individual saved programmes are listed in Favourites From here they can be 1 retrieved for therapy or 2 edited sequence changed or deleted Selecting Favourites Press the button to open Favourites Se...

Страница 91: ...s 17 Editing Favourites Press the button to open the Edit Favourites screen Selecting the programme Select the program to be edited by clicking on the appropriate row Changing sequence Activate the ap...

Страница 92: ...iting favourites and memory 17 2Editing favourites 17 Deleting a programme Pressing the button triggers the security question Delete Press the button to delete the saved program Press the button to ke...

Страница 93: ...ng Memory Press the button to open the Memory Selecting therapy Select the desired programme by pressing on the appropriate row Editing Memory Note The following steps to edit the Memory correspond ex...

Страница 94: ...Currents programmes for sports rehabilitation They generally consist of warm up training and relaxation phases Therapy screen for a preset programme Sequence display The currently active sequence 1 to...

Страница 95: ...starting the therapy Activating the sequence window Press the field to open the Sequences window Before starting the sequence therapy the intensity surges are defined here for the individual sequences...

Страница 96: ...muscle strengthening Press the field to open the Sequences window Select sequence 2 by clicking on the row It is highlighted in blue after activation Confirm sequence 2 with OK Define the intensity fo...

Страница 97: ...ow It is highlighted in blue after activation Confirm sequence 3 with OK Define the intensity for sequence 3 using the two intensity buttons Note After defining the intensities the therapy time runs t...

Страница 98: ...equence 1 Press the field to open the Sequences window Activate sequence 1 by directly pressing on the row and confirm with OK By activating sequence 1 the therapy time is reset to the predefined valu...

Страница 99: ...Starting therapy Click the button to start the therapy The three sequences run in succession The change of sequence is indicated by an acoustic signal Ending therapy When the therapy time has finished...

Страница 100: ...ge medium frequency innervation test PA 01 Neofaradic test PA 02 Chronaxia accommodation quotient PA 03 Fischgold test Various programmes with all the pulse shapes suitable for paralysis therapy are a...

Страница 101: ...ting the intensity the Pulse button becomes active Implementation Trigger a single pulse by setting an appropriate intensity and pressing the button Then the test is repeated on healthy muscle If the...

Страница 102: ...ted A muscle is normally innervated if it reacts with a contraction equal in length to an excitation time of one minute An innervation disorder can be assumed if no contraction or only a short contrac...

Страница 103: ...ch the accommodation quotient is calculated Screenshot Rheobase Surge current magnitude for triggering a minimum muscle twitch with a square wave pulse of 1000 ms Implementation Calculating rheobase S...

Страница 104: ...y cannot be modified in this step Chronaxie Pulse duration for triggering a minimum muscle twitch at a surge current strength that is double the rheobase value Calculating chronaxia Step 1 Increase pu...

Страница 105: ...ommodation quotient Surge intensity mA of the RPC at 1000ms rheobase TPC triangular pulse characteristic RPC rectangular pulse characteristic Calculating accommodation threshold Step 1 Set an appropri...

Страница 106: ...0 05 ms Hyperexcitability 0 05 1 ms Normal excitability 1 20 ms Partial degeneration 20 ms Complete degeneration Normal chronaxia values according to Edel Anterior muscles front of body Proximal 0 08...

Страница 107: ...phase 2 the intensity I2 of the first muscle twitch is calculated for a square wave pulse of 100 ms The quotient FGq I1 I2 is shown as the result Screenshot Conducting measurement phase 1 Step 1 Set a...

Страница 108: ...phase 2 in the same way as phase 1 After the measurement the calculated values are shown at the top right of the screen Evaluation of the quotients 1 7 normally functioning neuromuscular system 1 7 pa...

Страница 109: ...nt disease chronic Radicular syndrome in spinal diseases subacute and chronic Ligament ruptures Tendovaginitis Bursitis Analgesic therapy Distortions contusions muscular tendon and joint sprains Wides...

Страница 110: ...Myofascial pain syndrome Tendon and muscle ruptures Contractures Other indications Periarthropathy and insertion tendinopathy acute subacute Periarthropathy and insertion tendinopathy chronic Peripher...

Страница 111: ...stinal motility disorder Chronic constipation Secondary lymphoedema and lymph stasis Pelvipathy Polyneuropathy Anterior horn cell disease of the spinal cord Peripheral paralysis plexus paralysis Non l...

Страница 112: ...s indicated Joint degeneration Periarthropathy Epicondylopathy Tendinosis periostitis heel spurs Achillodynia Scars contractures Dupuytren s contracture Posttraumatic disorders Fractures particularly...

Страница 113: ...edominantly psychogenic pain TENS therapy is ineffective Central pain syndrome e g thalamic pain syndrome Additional contraindications Muscular treatment with surged pulse groups surging currents is c...

Страница 114: ...hesis Do not apply ultrasound higher than C3 Do not apply ultrasound to parenchymatous or heat sensitive organs testes eyes pregnant uterus liver kidney etc Anaesthetised skin areas Temperature regula...

Страница 115: ...tructions at all times In the Operating Instructions this symbol stands for Caution with regard to possible damage to property Follow operating instructions Manufacturer Serial number Type BF as per I...

Страница 116: ...devices may cause oscillations in the output values of the electrotherapy device Please maintain a safe distance of several metres The recommended maximal current density for currents that could caus...

Страница 117: ...nt may alter its properties Do not bring the ultrasound head into contact with sharp or pointed objects as the aluminium head is easily scratched Disinfect the ultrasound head with standard disinfecta...

Страница 118: ...Power consumption max 60 VA Protection class II Mains fuse 2 x 3 15 A T Applied part Type BF Dimensions 322 mm x 234 mm x 130 mm Weight 2 1 kg Transport in original packaging only Operational environm...

Страница 119: ...g plate Power consumption max 50 VA Protection class II Mains fuse 2 x 0 5 A T Applied part Type BF Dimensions 322 mm x 234 mm x 130 mm Weight 3 0 kg Transport in original packaging only Operational e...

Страница 120: ...250 mApeak 250 mApeak 250 mApeak 250 mApeak CV 40 Vpeak 140 Vpeak 200 Vpeak 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 Interference currents IF xx CC...

Страница 121: ...5 cm ERA 2 3 cm at 800 kHz 0 8 MHz 4 cm at 2 4 MHz Maximum output 7 W at 800 kHz 0 8 MHz 10 W at 2 4 MHz Intensity steps 0 1 to 3 W cm eff in steps of 0 1 W cm Accuracy 20 This value represents the le...

Страница 122: ...ative pressure 12 60 kPa Pulse operation Period duration adjustable from 1 to 8 s in steps of 0 5 seconds duty factor 1 1 Accuracy 20 This value represents the legally permissible value required by la...

Страница 123: ...d heads with tap water Disinfect the ultrasound heads with standard alcohol free disinfectant suitable for plastic Vaco electrodes Clean the suction cups with tap water with standard cleaners detergen...

Страница 124: ...rubber bands or Velcro Please note that rubber electrodes may quickly lose conductivity when used with monophase currents Insert the electrodes fully into the sponge holders and apply to the body with...

Страница 125: ...ally sensible sizes allow individual therapy appropriate for the symptoms Disposable electrodes are particularly well suited to therapy with bipolar currents for therapy with monopolar pulsed currents...

Страница 126: ...is recommended to use sponge holders for rubber electrodes and sponges which should be at least 1 to 2 cm thick for zinc plate electrodes Tap water is recommended to moisten the sponges distilled wate...

Страница 127: ...The product Soleo SonoStim is rated in Class IIb according to Annex IX of the Directive The product Soleo Galva is rated in Class IIa according to Annex IX of the Directive The product VacoS is rated...

Страница 128: ...lligator clip black 21 Disposable electrodes 135 pairs small 1 package 22 Disposable electrodes 90 pairs medium 1 package 23 Disposable electrodes 45 pairs large 1 package 43 Plate electrodes 9 x 12 c...

Страница 129: ...135 pairs small 1 package 22 Disposable electrodes 90 pairs medium 1 package 23 Disposable electrodes 45 pairs large 1 package 43 Plate electrodes 9 x 12 cm pure tin 96 Iontophoresis sponge 212 Membra...

Страница 130: ...connecting cables for Soleo SonoStim Soleo Galva 1 mains connecting cable short 4 sorting racks for Vaco electrode sleeves 1 water bottle Accessories Item No 95 Viscose sponge large for 72 94 Viscose...

Страница 131: ...121 Device combinations 31 Soleo SonoStim and Soleo Galva can be combined with VacoS The party that combines and uses the devices as a medical system is responsible for correct assembly of the devices...

Страница 132: ...nsions reconfigurations or modifications are implemented only by persons authorised by Zimmer MedizinSysteme users must ensure that the device is operating correctly and is in good repair before using...

Страница 133: ...graph must be completely full at maximum intensity Run the test consecutively with both channels Ultrasound Select ultrasound head and cover the ultrasound head with gel The coupling display must show...

Страница 134: ...observed when installing and operating the therapy devices Soleo SonoStim and Soleo Galva General information Store the Operating Instructions so they are accessible to operators of the device at all...

Страница 135: ...als or a faulty patient fuse Press OK to clear the message Excess current This refers to an increase above the maximum allowable current A current increase in continuous mode generally indicates a fau...

Страница 136: ...ges Troubleshooting Disposal 35 No SD card found If the SD card is not inserted the message No SD card found appears when the Indications Favourites and Memory buttons are pressed Insert the card and...

Страница 137: ...attached and connected with a Vaco electrode Check that the Vaco electrodes are correctly applied to the patient Vacuum button deactivates If the Vacuum button deactivates there may be a transmission...

Страница 138: ...suction which is used to empty the water separator Under some circumstances repeatedly creating suction is necessary to completely empty the water separator Disconnecting the bottle The bottle is rem...

Страница 139: ...ce can be contacted through your authorised sales representative or by contacting the head office in Neu Ulm Germany The device must be sent to the factory in the original packaging only Head office Z...

Страница 140: ...ic environments specified below The customer or the user of the Soleo SonoStim Soleo Galva device should ensure that the device is used in such an environment Emissions tests Compliance Electromagneti...

Страница 141: ...erential mode 2 kV common mode 1 kV differential mode 2 kV common mode The quality of the supply voltage should correspond to a typical business or hospital environment The quality of the supply volta...

Страница 142: ...0 MHz 10 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should be used no closer to any part of Soleo SonoStim Soleo Galva including cables than the recommended separation dista...

Страница 143: ...radiated RF disturbances are controlled The customer or user of the Soleo SonoStim Soleo Galva device can help prevent electromagnetic interference by maintaining a minimum distance between portable a...

Страница 144: ...Version 2 03 2011 Right of modifications reserved Soleoline Zimmer MedizinSysteme GmbH Junkersstra e 9 D 89231 Neu Ulm Tel 49 731 97 61 291 Fax 49 731 97 61 299 export zimmer de www zimmer de Operatin...

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