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Zimmer Soleo Sono Instructions For Use Manual Download Page 44

Safety Check (STK) 

Metrological Controls (MTK) 

17 

Page 35 

The Soleo Sono device is not listed in Annex 1 of MPBetreibV (Medical Device 

Operating Directive). 

The device is not listed in Annex 2 of MPBetreibV (Medical Device Operating 

Directive). 

In Germany, the DGUV regulation 3 (Electrical Systems and Equipment) in its current 

version must also be observed.

 

Note: 

These notes apply to the operation of the device in Germany. If applicable, observe 

any divergent national regulations that apply in your country. 

Summary of Contents for Soleo Sono

Page 1: ...Instructions for Use Soleoline Soleo Sono EN ...

Page 2: ......

Page 3: ...Soleo Sono Front panel Fig 1 Device and operating elements 1 Intensity controller channel I 2 Controller for frequency portion 3 Tray mount for ultrasound head 4 Display 5 Touch pen in holder 6 Slot for SD card 1 2 3 4 5 3 6 ...

Page 4: ...g 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 Programs Switches to the program list E Favourites Switches to the favourites area F Scroll backwards Moves back one page G Scroll forwards Moves forwards one page F E D C B A G 9 10 8 7 10 ...

Page 5: ...nector Sockets Fig 4 Switches and connector sockets 11 On off switch 12 Holder for mains fuse 13 Connection for mains cable 16 Connector for ultrasound head 0 8 2 4 MHz 18 Label Note For Soleo Sono the sockets 14 15 and 17 have no function 11 12 14 13 15 16 17 18 ...

Page 6: ...Explanation of Symbols Soleo Sono Ultrasound heads Fig 5 Ultrasound head large Ultrasound head small ...

Page 7: ...In 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 Date of manufacture This symbol indicates danger areas on the machine Interval operation ...

Page 8: ...ion Information 3 1 General 3 2 Ultrasound heads 4 5 4 Warnings 6 5 Soleoline in brief 7 6 Intended Use 8 7 7 Device Set up 7 1 Installation of Cables 9 8 Basic Settings 8 1 General 8 2 Ultrasound Therapy 8 3 Maintenance 10 13 14 9 Operating Instructions 9 1 Ultrasound therapy 9 2 Displays Buttons 9 3 Water Bath Treatment 9 4 SD Card 9 5 Indication Menu 9 6 Storing Programs 9 7 Run Programs Editin...

Page 9: ...inations 32 15 Safety and Maintenance 33 16 Function Test 34 17 Legal Notices 35 18 Error Message Troubleshooting Disposal 36 19 37 Manufacturer s EMC Declaration Valid for Soleo Sono 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 Information as of August 2016 ...

Page 10: ... Arthrosis Periarthropathies Epicondylopathy Tendopathies periostosis calcaneal spurs Achillodynia Scars contractures Dupuytren s contracture Posttraumatic arthritis Fractures particularly in cases of delayed callus formation Other indications Bronchial asthma Rhinopathy Persistent symptoms of the cervical spine after whiplash injury with recurrent blockages Headache Earache Post herpetic neuralgi...

Page 11: ... 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 sensitivity disorders After treatment with ionizing radiation Epiphyseal plates Tumours Electronic pacemakers Application on or in the vicinity of open wounds Impaired reflexes or pain sensitivity Application to the abd...

Page 12: ...Side Effects 2 Page 3 Side effects of ultrasound therapy If used correctly no side effects are known ...

Page 13: ...e device 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 Caution The device is not suitable for use in areas with an explosive combustible or combustion promoting atmosphere Caution During use the device must be placed in such a way that direct acce...

Page 14: ... damage the ultrasound head Disinfect the ultrasound head after use using commercially available equipment disinfectants Inspect the ultrasound head for damage prior to each use If damaged it must not be used Caution In the event of regular use of the ultrasound head in the water bath the user must take protection measures All body parts of the user immersed in the water must be protected by appro...

Page 15: ...tion and intensity of treatment require medical knowledge and may only be issued by licensed physicians therapists and members of the auxiliary medical professions It is imperative that these instructions 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 out o...

Page 16: ...anged colour display that provides all therapy related parameters as well as modern touch operation Customisable program start up settings and a clear simple menu offer maximum convenience for the user The compact design allows space saving work in the practice room and is ideally suited for use during home visits What is offered by Soleo Sono The delivery of therapeutic ultrasound via a modern sl...

Page 17: ...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 vacuum unit Soleo Galva A device for electrotherapy with the option of the additional use of a vacuum unit ...

Page 18: ...ble to the mains Note The device may only be connected to power outlets with a protective contact Switch the device on The device is switched on via the toggle switch 11 Switch the device off The device is switched off via the toggle switch 11 To completely disconnect the device all phase from the network remove the power cord Caution All cables must be protected against jamming or other mechanica...

Page 19: ...he self test performed the start up screen opens Selecting configuration Pressing button opens select configuration Configuration menu In the configuration menu the factory settings can be changed and adjusted individually After activating the configuration menu the configuration selection screen becomes active Settings General The settings options are shown below By default the factory settings a...

Page 20: ...gram start up settings The selection is made directly in the corresponding row Startup screens Choice of two start up screens The selection is made directly in the corresponding row 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 ...

Page 21: ... using the two arrow keys Note The screensaver function is disabled when therapy is in progress Welcome text Option to enter a personalised welcome text Activating the field opens the on screen keyboard for entering a greeting text Set Defaults Touching button restores the default factory settings Version Touching button opens a window with information regarding the current software version Touch ...

Page 22: ...the menu opens the Ultrasound therapy configuration selection screen Coupling signal Adjustment 50 to 95 of the coupling limits value The adjustment is made using the two arrow keys Unit Adjustment of unit intensity on the bar graph The selection is made directly in the corresponding row ...

Page 23: ... 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 24: ... button opens the programme screen Here the desired programme may be selected Programmes of Soleo Sono In Soleo Sono there are 9 different programmes available Programme selection The desired ultrasonic therapy program is selected directly in the corresponding row in this case US 01 ...

Page 25: ...e therapy screen opens Note Before starting treatment check that the data in the parameter window in this case 5 cm corresponds with the connected ultrasound head Adjusting the intensity Adjust the intensity using the left intensity controller Note The percentage frequency ratio can be changed using the right controller ...

Page 26: ...herapy time counts down at one second intervals The coupling display is active 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 The display in the lower status bar changes from Active to Ready The therapy time is a...

Page 27: ...he text Active appears 5 Therapy time Displays the therapy time for the selected program Using the arrow buttons the preset therapy time can be increased or shortened After the start of therapy the current remaining therapy time is displayed 6 Title bar In the title bar the name of the current ultrasound therapy program is displayed 7 Pulse The display shows the selected mode continuous or pulsed ...

Page 28: ...he water bath button and confirming with OK temperature monitoring of the ultrasound head is modified to suit water bath therapy Note Upon completion of water bath therapy it is possible that the temperature of the ultrasound head is too high for therapy outside the water bath This is displayed in the status bar with the message Ultrasound head temperature control Therapy is not possible during th...

Page 29: ...ustom 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 and Memory buttons Deactivate the message as described in Chapter 18 ...

Page 30: ... the body in this case the shoulder the indications window opens that lists various diseases affecting the shoulder area The symptom is selected directly in the respective row in this case shoulder arm syndrome Selecting a differentiated clinical picture After selecting the symptom another window opens with differentiated clinical pictures The differentiated clinical picture is selected directly i...

Page 31: ...erapy information After selecting the differentiated clinical picture another window opens with detailed therapy information and a program recommendation Selecting the therapy program Touching button opens the therapy screen with the corresponding programme ...

Page 32: ...e 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 program name Entry of a personal program name is carried out using the keyboard Note When entering a personal program name the program name in the input field must be deleted first Note The programs can be saved in the...

Page 33: ...tomatically 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 moves the program to the corresponding list The program is always stored in the first available slot on the list Pressing button 3 cancels the save operation 1 2 3 ...

Page 34: ...vourites 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 list Calling up a program The desired program is selected directly in the corresponding row Editing the favourites list By pressing buttons 1 and 2 the individual favourite pages can be viewed Button 1 scrolls forwards and...

Page 35: ...ing 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 Touching button 4 triggers a confirmation prompt Do you really want to delete the program Touching the Yes button deletes the program Touching the No button cancels the delete routine 1 2 4 3 ...

Page 36: ...ration 30 minutes on 10 minutes off Dimensions 322mm x 234mm x 130mm Weight 2 1kg Operation 10 C to 50 C 10 to 90 relative humidity without condensation at 700 hPa 1060 hPa 10 C to 50 C 10 to 90 relative humidity without condensation at 700 hPa 1060 hPa Storage and transport in original packaging only Subject to technical modifications Transport Storage Note 10 C to 35 C 30 to 75 relative humidity...

Page 37: ... of 0 1 W cm Ultrasound head large 5 cm ERA 2 30 cm at 0 8 MHz 2 38 cm2 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 Sound forms 1 Continuous ultrasound 2 Impulse noise adjustable pulse frequencies 20 Hz 50 Hz 100 Hz Duty ratio 1 1 1 2 1 3 1 5 1 10 Interchangeability Ultrasound heads are calibrated ex works and c...

Page 38: ...cations of the manufacturer of the cleaning agent so that it is not dripping Disinfection We recommend disinfecting the device at least once a week or upon signs of contamination Consult with your health professional when doing so Always perform cleaning prior to disinfection Housing can be disinfected using disinfectant wipes To do so use a commercially available alcohol fee disinfectant for meta...

Page 39: ...0 The product bears the CE mark in accordance with EC Directive 93 42 EEC concerning medical devices Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de ...

Page 40: ...nstructions for use Accessories Art No 4200 Ultrasound head 0 8 and 2 4 MHz ø 28 mm 4220 Ultrasound head 0 8 and 2 4 MHz ø 13 mm 118 Mains cable 65910321 Tray mount right 65910311 Tray mount left 65800410 Touch pen 6 Sono plus 1 bottle 87054001 Pocket for Soleoline 87053000 Case for Soleoline 10101394 Instructions for use Standard cable Other country specific plug types are available If necessary ...

Page 41: ...ations 14 Page 32 The Soleo Sono device is not intended for combination with other devices If the operator combines devices medical system then the operator has the sole responsibility for ensuring correct assembly ...

Page 42: ... 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 the mains in the event of the penetration of liquids the device is not operated in hazardous areas and or a combustive atmosphere The device does not contain any parts that can be serviced and repaired by...

Page 43: ...ormed as described below These tests should be performed monthly or in case of any doubt regarding the correct function of the device Ultrasound Select the ultrasound head and cover the ultrasound head surface with coupling gel In the case of starting therapy with low power the coupling display must show more than 90 Run the test with both ultrasound heads one after the other Then clean the ultras...

Page 44: ...ive The device is not listed in Annex 2 of MPBetreibV Medical Device Operating Directive In Germany the DGUV regulation 3 Electrical Systems and Equipment in its current version must also be observed Note These notes apply to the operation of the device in Germany If applicable observe any divergent national regulations that apply in your country ...

Page 45: ... then switching the device on again Otherwise please contact customer service You can reach 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 contact the address listed Headquarters Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 4...

Page 46: ...er or the user of the Soleo Sono must ensure that it is operated in such an environment Emissions measurements Compliance Electromagnetic environment guidelines RF emissions in accordance with CISPR 11 Group 2 The Soleo Sono device must emit electromagnetic energy in order to perform its intended function Nearby electronic equipment may be affected RF emissions in accordance with CISPR 11 Class B ...

Page 47: ...h IEC 6100 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Not applicable The supply voltage quality must correspond to that of a typical commercial or hospital environment Voltage dips short term interruptions and voltage variations in accordance with 5 UT 95 dip in UT for period 40 UT 60 dip in UT for 5 periods 70 UT 30 dip in UT for 25 periods 5 UT 95 dip in ...

Page 48: ...z 10 V m 80 MHz to 2 5 GHz Portable and mobile RF communications equipment should not be used any closer to the Soleo Sono including cables than the recommended separation distance calculated using the equation relevant for the transmission frequency Recommended separation distance d 1 17 P d 0 35 P for 80MHz to 800 MHz d 0 7 P for 800 MHz to 2 5 GHz where P is the power rating of the transmitter ...

Page 49: ...ic environment in which RF disturbances are controlled The customer or the user of the Soleo Sono device can thus help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Soleo Sono device depending on the output power of the communications equipment as indicated below Rated power of the transmitter ...

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Page 52: ...r 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 Instructions for Use EN 10 101 394 UR 0317 I Version 3 I Right of modification reserved ...

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