Zimmer Soleo SonoStim Instructions For Use Manual
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Zimmer Soleo SonoStim Instructions For Use Manual

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Instructions for Use
Soleoline
Soleo SonoStim, Soleo Galva, Soleo VacoS
EN

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Summary of Contents for Zimmer Soleo SonoStim

  • Page 1 Instructions for Use Soleoline Soleo SonoStim, Soleo Galva, Soleo VacoS...
  • Page 3 Explanation of Symbols Soleo SonoStim / Soleo Galva Front panel Fig. 1 Device and 1 Intensity controller channel I operating 2 Intensity controller channel II elements 3 Alligator clips clipping options 4 Tray mount for ultrasound head 5 Display 6 Touch pen in holder...
  • Page 4 Explanation of Symbols Soleo SonoStim / Soleo Galva Display/ Navigation bars Fig. 2 Displays 8 Status bar 9 Buttons on the screen 10 Title bar 11 Navigation bars Fig. 3 Navigation bar (A) Back Moves back one step Description of...
  • Page 5 Explanation of Symbols Soleo SonoStim / Soleo Galva Rear Panel/Switches and Connector Sockets Fig. 4 (15*) Switches and 12 On/off switch connector sockets 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...
  • Page 6 Explanation of Symbols VacoS Front panel/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 electrode tube red, anode...
  • Page 7 27 Socket for electrode cable channel II 28 Socket for connection cable with SonoStim/Galva channel II 29 Socket for electrode cable channel I 30 Socket for connection cable with SonoStim/Galva channel I 31 Soleo SonoStim / Galva identification plate 32 Soleo VacoS identification plate...
  • Page 8 Explanation of Symbols Soleo SonoStim / Soleo Galva / VacoS Side view Fig. 8 Connections 33 Water separator connector valve...
  • Page 9 Explanation of Symbols Soleo SonoStim / Soleo Galva Ultrasound heads Fig. 9 Ultrasound head, large Ultrasound head, small...
  • Page 10 Explanation of Symbols In the instructions for use, this symbol indicates “Danger”. In the instructions for use, this symbol represents "Caution" with regard to Caution damage of the device. Device Type BF Follow the instructions for use Instructions for Use Serial number number Item...

  • Page 11: Table Of Contents

    1.4 Ultrasound therapy contraindications Side Effects Application Information 3.1 General 3.2 Electrotherapy 3.3 Ultrasound Warnings 4.1 General 4.2 Electrotherapy Soleoline – in brief Intended Use 7 Device Set up 7.1 Installation of Soleo SonoStim/Soleo Galva cables 7.2 Installation of the VacoS cable...
  • Page 12 9.2 Ultrasound Therapy 9.3 Water Bath Treatment 9.4 Simultaneous Therapy Soleo Galva - Instructions for operation 10.1 Electrotherapy Soleo SonoStim/Soleo Galva - Instructions for operation 11.1 Electrotherapy with VacoS 11.2 Water separator VacoS 11.3 SD card 11.4 Menu indications 11.5 Storing Programmes 11.6 Retrieving programmes/Editing the list...
  • Page 13 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.

  • Page 14: Electrotherapy Indications

    Indications / Contraindications 1.1 Electrotherapy indications Circulation promotion • Functional circulatory disorders treatment • Angiopathy in diabetes mellitus • Angioneuropathy (M. Raynaud) • Acrocyanosis • Arterial occlusive disease (stage I/IIa) • Venous vascular disease • Chronic venous insufficiency • Sympathetic reflex dystrophy •...
  • Page 15 Indications / Contraindications 1.1 Electrotherapy indications Trophism promotion • Venous ulcers treatment • Neurotrophic ulcers • Decubitus ulcers • Delayed wound healing • Osteoporosis • Delayed bone healing • Ligament ruptures Muscle toning therapy • Muscle weakness • Voluntary innervation weakness •...
  • Page 16 Indications / Contraindications 1.2 Contraindications for electrotherapy General • Vague pain symptoms Contraindications • Acute inflammation (local, systemic) • Suspected diseases of the cardiovascular system • (Suspected) epilepsy • Arterial occlusive disease from stage IIb according to Fontaine • Purulent processes •...

  • Page 17: Ultrasound Therapy Indications

    Indications / Contraindications 1.3 Indications for ultrasound therapy Indications from • Spinal pain syndromes, e.g. cervical spine syndrome orthopaedics, surgery, • Ankylosing spondylitis (only in inflammation-free intervals) traumatology, • Joint disorders rheumatology • Rheumatoid arthritis (if heat treatment is indicated) •...

  • Page 18: Ultrasound Therapy Contraindications

    Indications / Contraindications 1.4 Contraindications for ultrasound therapy General • Vague pain symptoms Contraindications • Diseases where heat should not be used, for example, acute inflammatory diseases • Diseases where mechanical impacts are contraindicated, e.g. deep vein thrombosis, • Restricted blood flow •...

  • Page 19: Side Effects

    Side Effects Side effects of If used correctly, no side effects are known. electrotherapy Side effects of If used correctly, no side effects are known. ultrasound therapy Page 6...

  • Page 20: Application Information

    Inspect the device before use. If damaged, it must not be used. Only accessories provided by Zimmer MedizinSysteme GmbH are to be used and no Caution other devices must be connected to the VacoS.

  • Page 21: Electrotherapy

    Application Information 3.2 Electrotherapy Electrode positioning and choice of treatment parameters should always be adapted to the treatment guidelines. For currents in which a chemical burn is possible (e.g. galvanic current, diadynamic current, currents with galvanic share), the recommended maximum current density is 2 mA rms/cm²...

  • Page 22: Ultrasound

    Application Information 3.3 Ultrasound Handle the ultrasound head carefully, as rough handling can alter its properties. Do not bring the ultrasound head into contact with sharp or pointed objects, as the aluminium head is susceptible to scratching. The use of a couplant other than the special Sono plus ultrasound gel can damage the ultrasound head.

  • Page 23: Warnings

    Warnings 4.1 General This product is intended for use by medical professionals only. Very important: Never connect two patients to the device in one treatment session! The patient must not be left unattended during therapy. Treatment instructions regarding the treatment location, duration and intensity of treatment require medical knowledge and may only be issued by licensed physicians, therapists and members of the auxiliary medical professions.

  • Page 24: Electrotherapy

    Warnings 4.2 Electrotherapy Electrotherapy Use of electrodes near the thorax may increase the risk of ventricular fibrillation. When performing an iontophoresis,the drug used may possibly have an analgesic effect and pain sensitivity is then reduced. Stimulation current can have a stimulating effect on insulin release. In diabetes patients this may therefore lead to hypoglycaemia.

  • Page 25: Soleoline - In Brief

    What is Soleoline? An ultra-modern innovative product line that provides 3 different device variants. Soleo SonoStim A state of the art, innovative combination device for electrotherapy and ultrasound therapy, with the option of the additional use of a vacuum unit.

  • Page 26: Intended Use

    The Soleoline product range includes 3 different device versions: Soleo Sono Ultrasound 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 vacuum unit.

  • Page 27: Device Set Up

    7 Device Set up 7.1 Installation of cables Soleo SonoStim / Soleo Galva Note: The following description of the installation of the cables refers to the operation of Soleo SonoStim/Soleo Galva without VacoS. Note: There are coloured arrows located on the cables as a guide for proper connection to the device.

  • Page 28: Installation Of The Vacos Cable

    7 Device Set up 7.2 Installation of cables for VacoS Note: The control and operation of VacoS is via Soleo SonoStim/Soleo Galva. A stand- alone operation is not possible. Preparation Position Soleo SonoStim/Soleo Galva so that the devices are aligned with each other.
  • Page 29 7 Device Set up 7.2 Installation of cables for VacoS Mounting the Vaco Connect the black Vaco electrode hose to the appropriate socket (1) on the front of electrode VacoS hose. I - . Connect the red Vaco electrode hose to the appropriate socket (2) on the front of VacoS Connect the black Vaco electrodes hose to the appropriate socket (3) on the front of VacoS...

  • Page 30: Basic Settings

    Basic Settings 8.1 General Note: The following descriptions always relate to the treatment with one channel and emanate the factory default settings. Note: Changes to the basic settings can only be made 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.
  • Page 31 Basic Settings 8.1 General Settings General The settings options are shown below. By default, the factory settings are pre-programmed as shown in the screen. Language Selecting the language The selection is made directly in the corresponding row. Program start up Adjustment of the program start up settings.
  • Page 32 Basic Settings 8.1 General Sounds Switching the signal tones on and off. The selection is made directly in the corresponding row. Volume Adjustment of the volume from 1 to 4. The adjustment is made using the two arrow keys. Brightness Adjustment of screen brightness from 0 to 10.
  • Page 33 Basic Settings 8.1 General 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 button to close the window. Page 20...

  • Page 34: Electrotherapy

    Basic Settings 8.2 Electrotherapy Electrotherapy settings Time Adjustment of a single treatment time of 1 to 60 minutes 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.

  • Page 35: Ultrasound Therapy

    Basic Settings 8.3 Ultrasound Therapy Note: Activation of the "SonoSwing" menu and the associated 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.

  • Page 36: Maintenance

    Basic Settings 8.4 Maintenance Maintenance Opens 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 planned. To open the maintenance menu, enter the password "armin". Page 23...

  • Page 37: Electrotherapy

    Soleo SonoStim – Instructions for operation 9.1 Electrotherapy Note: The following notice applies to all the system therapies. If the treatment time is extended individually, there may be a change in the method of operation and the patient must be observed during use with increased attention.

  • Page 38: Soleo Sonostim - Instructions For Operation

    Soleo SonoStim – Instructions for operation 9.1 Electrotherapy Current form The current form selection is made directly in the corresponding row. configuration (here NF 00). Therapy screen After selection of the current form, the therapy screen opens automatically on channel I.
  • Page 39 Soleo SonoStim – Instructions for operation 9.1 Electrotherapy Therapy startup By adjusting the intensity from the left intensity regulator, the display changes in the bottom status line from "ready" to "active" and the therapy is being performed. In the bar graph, the current flow is displayed and the therapy time counts down at one-second intervals.
  • Page 40 Soleo SonoStim – Instructions for operation 9.1 Electrotherapy Description of the display elements and buttons (1) Intensity The bar graph displays the intensity currently selected. In the CC mode, the display is in mA eff. or peak. In the CV mode, the display is in peak volts.
  • Page 41 Soleo SonoStim – Instructions for operation 9.1 Electrotherapy (6) Status line The status bar shows information regarding the current therapy status. If therapy is not active, the "Ready" display appears; when therapy is in progress the text "Active" appears. (7) Title bar In the title bar, the name of the current ultrasound therapy program is displayed.

  • Page 42: Ultrasound Therapy

    Soleo SonoStim – Instructions for operation 9.2 Ultrasound Therapy Program start up Touching button opens the programme screen. Here the desired programme may be selected. Selecting ultrasound The ultrasound therapy selection is made directly in the corresponding row. therapy Programme selection The desired ultrasonic therapy program is selected directly in the corresponding row (in this case US 01).
  • Page 43 Soleo SonoStim – Instructions for operation 9.2 Ultrasound Therapy Therapy screen After selecting the ultrasound therapy program, the therapy screen opens. Note: Before starting treatment, check that the data in the parameter window (in this case 5 cm²) corresponds with the connected ultrasound head.
  • Page 44 Soleo SonoStim – Instructions for operation 9.2 Ultrasound Therapy End of therapy After expiration of therapy time, an acoustic alert signals 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.
  • Page 45 Soleo SonoStim – Instructions for operation 9.2 Ultrasound Therapy Description of the display elements and buttons (1) Intensity The bar graph displays the currently set intensity. The intensity is adjusted using the left controller. (2) Start/Stop Pressing the button starts or stops the therapy.

  • Page 46: Water Bath Treatment

    Soleo SonoStim – Instructions for operation 9.3 Water Bath Treatment Note: If ultrasound therapy is performed in a water bath, the temperature monitoring of the ultrasound head must be modified prior to therapy. Performance Activating the parameter button opens the ultrasound parameters window.

  • Page 47: Simultaneous Therapy

    Soleo SonoStim – Instructions for operation 9.4 Simultaneous Therapy Program start up Pressing the button opens the programme screen. Here the desired programme may be selected. Selecting The simultaneous therapy selection is made directly in the corresponding row. simultaneous therapy...
  • Page 48 Soleo SonoStim – Instructions for operation 9.4 Simultaneous Therapy Therapy screen After selecting the simultaneous therapy programme, the therapy screen opens. Setting the Adjust the intensity using the left intensity controller. intensity of the ultrasound Therapy startup By adjusting the intensity over the right intensity controller, simultaneous therapy is active.
  • Page 49 Soleo SonoStim – Instructions for operation 9.4 Simultaneous Therapy End of therapy After expiration of the treatment time, an acoustic alert signals 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.

  • Page 50: Soleo Galva - Instructions For Operation

    Soleo Galva – Instructions for operation 10.1 Electrotherapy Program start up Activation of button opens the electrotherapy programme window. Selecting the current The selection of the desired current category is carried out directly in the form group corresponding row (rectangular monophasic currents here). Note: The next steps for the implementation of the therapy are described in detail in chapter 9.1.

  • Page 51: Electrotherapy With Vacos

    Note: If there is no vacuum unit available, the "vacuum" button does not appear. This is also true if the data transfer or the connection of the vacuum unit to Soleo SonoStim/Soleo Galva is disturbed or interrupted. Opening the vacuum...
  • Page 52 Soleo SonoStim / Soleo Galva Instructions for use 11.1 Electrotherapy with VacoS Starting By adjusting the intensity from the left intensity regulator, the display changes in the electrotherapy bottom status line from "ready" to "active" and the therapy is being performed. In the bar graph, the current flow is displayed and the therapy time counts down at one- second intervals.
  • Page 53 Soleo SonoStim / Soleo Galva Instructions for use 11.1 Electrotherapy with VacoS Description of the display elements and buttons Note: After pressing the "vacuum" button, the parameter window opens. (1) Start/Stop Activation or deactivation of this button starts and stops the suction of the electrodes with the basic vacuum.

  • Page 54: Water Separator Vacos

    Soleo SonoStim / Soleo Galva Instructions for use 11.2 VacoS water separator Water separator VacoS includes an integrated water 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 separator".

  • Page 55: Sd Card

    Soleo SonoStim / Soleo Galva Instructions for use 11.3 SD card 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"...
  • Page 56 Soleo SonoStim / Soleo Galva Instructions for use 11.4 Indications menu The indication menu is used to assist in the choice of therapy. Selecting a region of A region of the body is selected by clicking the blue circle. the body...
  • Page 57 Soleo SonoStim / Soleo Galva Instructions for use 11.4 Indications menu Therapy information After selecting the differentiated clinical picture, another window opens with detailed therapy information and a program recommendation. Selecting the therapy Touching button opens the therapy screen with the corresponding programme.

  • Page 58: Storing Programmes

    Soleo SonoStim / Soleo Galva Instructions for use 11.5 Storing programmes Note: In order to save programs, the SD card must be properly inserted into the SD card slot. If this is not the case, it is not possible to save programs.
  • Page 59 Soleo SonoStim / Soleo Galva Instructions for use 11.5 Storing programmes Saving to the Favourites list / Memory list Touching button (1) opens the favourites 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.

  • Page 60: Retrieving Programmes/Editing The List

    Soleo SonoStim / Soleo Galva Operating Instructions 11.6 Retrieving programmes/Editing the list Individually saved programs are listed in the favourites list. Here these can be called up in order to implement therapy or edited (the sequence altered or deleted). Note: The steps to retrieve and editing the favourites / memory list are identical;...
  • Page 61 Soleo SonoStim / Soleo Galva Operating Instructions 11.6 Retrieving programmes/Editing the list Editing favourites The programme to be processed is selected directly in the corresponding row. Touching button (1) returns you to the favourites list. Touching button (2) scrolls the program up.

  • Page 62: Programme Sequence

    Soleo SonoStim / Soleo Galva Operating Instructions 11.7 Programme sequence Sequence programmes are a combination of up to three electrotherapy programmes that are launched in direct succession one after another automatically. In the programme family "currents for sports rehabilitation", various programmes are predefined at the factory.
  • Page 63 Soleo SonoStim / Soleo Galva Operating Instructions 11.7 Programme sequence 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 period, this is indicated by an acoustic signal at the end of treatment.

  • Page 64: Paralysis Diagnosis And Therapy

    Paralysis diagnosis and therapy 12.1 Overview In Soleo SonoStim / Soleo Galva, there are special programmes for the diagnosis and treatment of paralysis and flaccid paralysis. With the diagnostic programmes, clues for assessing the severity of flaccid paralysis can be obtained, making it possible in a simple manner to individually set the parameters necessary for the treatment.

  • Page 65: Medium Frequency Test By Lange

    Paralysis diagnosis and therapy 12.2 Medium frequency test by Lange The medium frequency test according to length gives a rough indication of whether a muscle is partially or completely denervated. The electrodes are placed in the centre of the muscle to be examined. Display screen Note: When using full intensity, the "pulse"...

  • Page 66: Neofaradic Test

    Paralysis diagnosis and therapy 12.3 Neofaradic test The faradic test tells you whether a muscle is innervated 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 contractions are observed. Display screen Performance After selecting the intensity, the stimulus time of 1 minute is started.

  • Page 67: Chronaxie/Accomodation Quotient

    Paralysis diagnosis and therapy 12.4 Chronaxy/accommodation quotient This programme is used to perform a simple and rapid diagnosis. It consists of 3 programme steps in which rheobase, chronaxie and the accomdation thresholds are measured and the accompdation quotient determined. Display screen Rheobase Threshold current to induce a minimal muscle twitch with a rectangular pulse of 1000 Identifying/assuming...
  • Page 68 Paralysis diagnosis and therapy 12.4 Chronaxy/accommodation quotient Accomodation Threshold current to induce a minimal muscle twitch with a triangular pulse of 1000 threshold Accommodation Intensity threshold (mA) of DIC at 1000 ms quotient _____________________________________________ Intensity threshold (mA) of RIC at 1000 ms (Rheobase) Triangular impulse response Rectangular impulse response Identifying/assuming...
  • Page 69 Paralysis diagnosis and therapy 12.4 Chronaxy/accommodation quotient Chronaxie assessment <0.05 ms hyperexcitability 0.05 to 1 ms normal excitability 1 - 20 ms partial degeneration > 20 ms 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)

  • Page 70: Fisch Gold Test

    Paralysis diagnosis and therapy 12.5 Fisch Gold Test This programme is used to perform a simple and rapid diagnosis. The measurement is carried out in 2 phases: In phase 1, the intensity I1 of the first muscular contraction is determined at a square pulse of 1 ms pulse width.
  • Page 71 Paralysis diagnosis and therapy 12.5 Fisch Gold Test Assessment of the quotients < 1.7: normally functioning neuromuscular system > 1.7: partial degeneration Should one of the two intensities not be determined, the degeneration is complete. Page 58...

  • Page 72: Technical Information

    Technical Information 13.1 Soleo SonoStim / Soleo Galva Power supply 100 - 240 V / 50 Hz / 60 Hz 220 V / 60 Hz Mains fuse 2 x T2AL, 250 V, 5x20 mm Electrical energy max. 60 VA consumption...

  • Page 73: Stimulation

    Technical Information 13.2 Stimulation Output power 200 Ω 500 Ω 1000 Ω 2000 Ω Galvanisation 80 mA 80 mA 80 mA 80 mA GA xx 14 V 40 V 60 V 60 V Diadynamic currents 6 mA 20 mA 20 mA 20 mA DD xx 16 V...
  • Page 74 Technical Information 13.2 Stimulation Parameters of current forms Program Max. Current Max. voltage Current forms Frequency Pulse (CC) (CV) name Galvanisation GA xx 80 mA 60 V Diadynamic currents DF: 100 Hz, DD xx 20 mA MF: 50 Hz, 60 V 7.5 ms CP, LP: 50/100 Hz High-voltage currents...

  • Page 75: Ultrasound

    Technical Information 13.3 Ultrasound Ultrasound heads Frequency 0.8 MHz and 2.4 MHz Ultrasound head, small 1 cm², ERA = 0,67cm² at 0.8 MHz, 0.65 cm at 2.4 MHz Maximum power 1.0 W at 0.8 MHz, 0.6 W at 2.4 MHz Intensity levels 0.1 to 1 W/cm²...

  • Page 76: Vacos

    Technical Information 13.4 VacoS Mains voltage 100 – 120 V / 50 Hz / 60 Hz (1) 230 – 240 V / 50 Hz / 60 Hz 220 V / 60 Hz (2) Mains fuse 2 x T 0.4 AL, 100 – 120 V, 5 x 20 mm 2 x T 0.2 AL, 230 –...

  • Page 77: Cleaning Disinfection

    Cleaning Disinfection - Before starting any cleaning and maintenance measures, the device must always be switched off at the main switch and unplugged. - Make sure that during cleaning and disinfection no liquids penetrate the device. Do not use sprays. - If liquid penetrates the device during cleaning or disinfecting, please put the unit out of service, protect it from getting used again and contact your service representative.
  • Page 78 Cleaning Disinfection Vaco electrodes Cleaning: The Vaco electrodes can be cleaned of any visible dirt with commercially available soft plastic cleaners. Unplug the Vaco electrode from the electrode hose and invert the suction cup completely. Dip the Vaco electrode into a cleaning solution prepared according to the manufacturer of the detergent and clean the electrode thoroughly using a stiff brush.

  • Page 79: Electrodes - Information On Use Of The Various Types Of Electrodes

    For the Soleo SonoStim/Soleo Galva, all electrodes standard in electrotherapy must be connected by means of an insulated cable clamp.

  • Page 80: Ce Mark/Manufacturer

    CE Mark/Manufacturer The products bear the CE marking in accordance with EC Directive 93/42/EEC concerning medical devices. Manufacturer Zimmer MedizinSystems GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax: +49 731. 9761-299 www.zimmer.de Page 67...

  • Page 81: Scope Of Delivery Accessories

    Scope of delivery Soleo SonoStim item no. 5302 1 basic device Soleo SonoStim (see below) 2 pairs of electrode cables with twist protection and magnetic clip, incl. 2 red and 2 black alligator clips, 2.90 m long 1 ultrasound head 0.8 and 2.4 MHz, ø 28 mm...

  • Page 82: Soleo Galva

    Scope of delivery Accessories 17.2 Soleo Galva Scope of delivery Soleo Galva Art. No. 5330 1 basic device Soleo Galva (see below) 2 pairs of electrode cables with twist protection and magnetic clip, incl. 2 red and 2 black alligator clips, 2.90 m long 1 tray mount, right 1 tray mount, left 1 mains cable*...

  • Page 83: Vacos

    2 pairs Vaco electrodes ø 90 mm, self-closing with sponges 2 pairs Vaco electrodes ø 60 mm, self-closing with sponges 2 connection cables for Soleo SonoStim / Soleo Galva 1 mains connection cable, 50 cm 4 pieces sorting combs for Vaco lines incl. magnetic clip...

  • Page 84: Device Combinations

    Device Combinations 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 connection. Page 71...

  • Page 85: Safety And Maintenance

    Safety and Maintenance Soleo SonoStim / Soleo Galva are manufactured according to EN 60601-1 safety regulations. As the manufacturer, Zimmer MedizinSysteme can only be considered responsible for safety and reliability if • the equipment is operated using a proper power outlet with an earthing contact and the electrical installation complies with DIN VDE 0100 Part 710, •...

  • Page 86: Function Test

    Function Test Soleo SonoStim / Soleo Galva performs a self-test after turning on, which checks all internal components. In the event of a fault, an error message appears. In addition, an extended function test can be performed as described below for all 3 modes.

  • Page 87: Legal Notices

    Legal Notices The Soleo Galva, SonoStim and optionally available VacoS devices are listed in Annex 1 of MPBetreibV (Medical Device Operating Directive). Please observe the measures stipulated therein. The devices are not listed in Annex 2 of MPBetreibV (Medical Device Operating Directive).

  • Page 88: Error Message, Troubleshooting, Disposal

    Error Messages Troubleshooting Disposal Cable inspection Means with the current stimulation therapy in constant current mode: Interruption of the patient circuit. As a rule, this message concerns disconnected electrodes, dirty electrode terminals, a defective patient cable or defective patient safety. Clear message by confirming "OK".
  • Page 89 Check the following in this case, • whether Soleo SonoStim / Soleo Galva is connected correctly to VacoS • whether Soleo SonoStim / Soleo Galva is connected to VacoS via the connecting cable • whether VacoS is turned on.
  • Page 90 Error Messages Troubleshooting Disposal VacoS Water separator full If the water separator is full, a message appears on the display "empty water separator". The water is emptied by means of a water bottle that comes with VacoS . Close the message "empty water"...
  • Page 91 Neu-Ulm. The device must be returned to the factory in its original packaging. For questions or equipment malfunctions, please contact the address listed: Headquarters Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu-Ulm, Germany Tel. +49 731. 9761-291 Fax: +49 731. 9761-299 www.zimmer.de...

  • Page 92: Manufacturer's Emc Declaration

    Portable and mobile RF communications equipment (e.g. mobile phones) can affect electrical medical equipment. Soleo SonoStim / Soleo Galva may only be operated with the original parts specified in the list of the delivery and accessories. The operation of the device with other parts may result in increased emissions or in the device's decreased interference immunity.
  • Page 93 Guidelines and manufacturer's declaration - electromagnetic immunity The Soleo SonoStim/Soleo Galva device is designed for operation in the electromagnetic environment specified below. The customer or the user of the Soleo SonoStim/Soneo Galva device should ensure that it is used in such an environment. Immunity tests...
  • Page 94 Guidelines and manufacturer's declaration - electromagnetic immunity The Soleo SonoStim/Soleo Galva device is designed for operation in the electromagnetic environment specified below. The customer or the user of the Soleo SonoStim/Soneo Galva device should ensure that it is used in such an environment. Immunity IEC 60601 –...
  • Page 95 RF transmitters, a study of the electromagnetic phenomena at the location should be considered. If the measured field strength in the location in which the Soleo SonoStim/Soleo Galva device is used exceeds the above compliance level, the Soleo SonoStim/Soleo Galva device must be monitored to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as the realignment or relocation of the Soleo SonoStim/Soleo Galva device.
  • Page 96 Soleoline Instructions for Use Zimmer MedizinSysteme GmbH Junkersstraße 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...

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