Operating Instructions Soleoline. Soleo Sono

Transcription

1 Operating Instructions Soleoline Soleo Sono GB

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3 Soleo Sono Front view of device Fig Selection and control elements 6 1 Intensity regulator 4 Screen 2 Frequency ratio regulator 5 Touch pen in holder 3 Slot for ultrasound head 6 SD card slot Fig Screen readouts 7 Status bar 9 Title bar 8 Navigation bar 10 Buttons on the screen

4 Fig. 3 Soleo Sono Rear view of device (15*) (16*) 14 (17*) Switch and connector sockets 11 Connector for mains cable 13 On/off switch 12 Fuse holder for mains fuse 14 Socket for 0.8/2.4 MHz ultrasound head Note: Sockets (15*), (16*) and (17*) have no function on Soleo Sono.

5 Contents Soleo Sono Front view of device Selection and control elements/screen readouts Rear view of device Switch and connector sockets 1. Soleoline Summary / Soleo Sono 1 2. Fitting the cables, Starting the system 2 3. Configuration 3.1 General Ultrasound therapy Attendance/Maintenance Quick operating instructions Water bath treatment General instructions SD card Description of the selection buttons Screenshot of the therapy screen Description of the screen elements and the buttons 8.1 Screen elements Buttons Indications menu Saving a modified programme Favourites Memory Retrieving and editing favourites and memory 11.1 Retrieving favourites Editing favourites Retrieving and editing memory 39 Page

6 Contents Page 12. Indications Contraindications Explanation of symbols Warnings Technical Information 16.1 General Specific Cleaning, Disinfection CE Marking Contents on delivery, accessories Safety and maintenance Functional test Error messages, Troubleshooting, Disposal Manufacturer's EMC declaration 52 Valid for the Soleo Sono device. These Operating Instructions are an integral part of the device. They must be stored with the device and kept accessible at all times for anyone authorised to operate this device. These Operating Instructions are valid from

7 Soleoline Summary 1 Soleo Sono What is Soleoline? An ultramodern and innovative range of products with 3 different devices available. Soleo Sono An ultramodern and innovative ultrasound therapy device. Soleo SonoStim An ultramodern and innovative combination device for electrotherapy and ultrasound therapy with the option of attaching a vacuum unit. Soleo Galva An ultramodern and innovative electrotherapy device with the option of attaching a vacuum unit. Note: What are the advantages of Soleoline? The operation of Soleo SonoStim and Soleo Galva is described in a separate set of operating instructions. 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 navigation make operation of the device easy and comfortable for users. The compact design saves room in the practice and is highly suited for use in house visits. What does the Soleo Sono do? Delivers therapeutic ultrasound via a modern variable frequency ultrasound head. Innovations in Soleo Sono? SonoSwing, the innovation in the field of ultrasound therapy: a single ultrasound head with two frequencies 0.8 MHz and 2.4 MHz freely selectable penetration depths using percentage adjustment of the frequency ratios. Note: The device should only be used by medical specialists (e.g., doctors, therapists and health paraprofessionals). 1

8 Fitting the cables Starting the system 2 Note: On the connector cable for the ultrasound head there is a green arrow as a guide for correct connection with the device. Connecting the ultrasound head When connecting the ultrasound head, ensure that the green arrow is pointing left when being plugged in. Connect the ultrasound head to the appropriate socket (14). Connecting the mains cable Plug the mains cable into the appropriate socket (11) on the device and then plug into the mains socket. Switching on the device Note: Switch on the device using the rocker switch (13). All buttons, menus and submenus are activated directly on the screen by touching it or using the touch pen. 2

9 Configuration General 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, the start screen opens. Selecting configuration Press the button to open the configuration menu. 3

10 Configuration General Configuration menu In the configuration menu the factory settings can be changed and individually set. After activation of the configuration menu the Choice of Configuration screen is active. Saving settings Press the / button to save the new settings. Closing the configuration menu Press the button to return to the start screen. General settings The setting options are outlined below. In the factory, the default settings are pre-programmed as shown on the screen. Language Press the arrow key drop-down menu to select the language. to open the The language is selected by pressing on the appropriate row. 4

11 Configuration General Start settings Configuration options for the programme start settings: Press the arrow button to open the drop-down menu to select the programme start configurations. The selection is made by pressing on the appropriate row. Start screen Option to choose between 2 start screens: Press the arrow button to open the drop-down menu to select the start screen. The selection is made by pressing on the appropriate row. 5

12 Configuration General Sounds To switch the signal sound on and off when activating the control fields: Press the arrow button to open the drop-down menu to switch sounds 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 button to open the window to adjust the volume. The volume is adjusted using both arrow keys. Brightness Option to adjust the screen brightness in steps from 0 to 10: The brightness is adjusted using both arrow keys. 6

13 Configuration General Screen saver Option to configure the start of the screen saver after 0 to 20 minutes: The start time is adjusted using both arrow keys. Note: While therapy is running, the screen saver function is deactivated. Welcome message Option to configure an individual welcome message. Press the field to open the screen keyboard to enter a welcome message. 7

14 Configuration General 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 to close the window. 8

15 Configuration Ultrasound therapy Ultrasound therapy settings Activate the menu to open the Ultrasound therapy configuration screen. The settings required for therapy can be adjusted here. Coupling signal Option to adjust (50 to 95%) the threshold for coupling: The threshold is adjusted using both arrow keys. 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 selection is made by pressing on the appropriate row. 9

16 Configuration Maintenance Maintenance Activate the menu / to open the Maintenance screen. The maintenance programmes are protected by passwords. Use the keyboard 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 update is planned. For Servicing other passwords are necessary. Servicing is permissible by Zimmer technicians or technicians trained by Zimmer only. 10

17 Quick operating instructions 4 Starting the programme Press the is selected here. button to open the Programme screen. The programme Soleo Sono programmes There are 9 different programmes available in Soleo Sono. 11

18 Quick operating instructions 4 Selecting the programme Select the 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 information shown on the Parameter button (here 5 cm 2 ) matches the ultrasound head connected before starting therapy. 12

19 Quick operating instructions 4 Setting intensity Adjust the intensity using the intensity controller on the left. Note: Change the percentage frequency ratio using the right hand regulator. 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 changes to Stop. The dose set is shown in the bar graph and the therapy time counts down in seconds. The coupling display is active. 13

20 Quick operating instructions 4 Ending therapy At the end of the therapy time an acoustic 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 display in the bottom status bar changes from Active to Ready. The therapy time is automatically reset and the Stop button changes to Start at the end of the therapy. 14

21 Quick operating instructions Water bath treatment Note: If the ultrasound therapy is done in a water bath, the ultrasound head temperature monitoring must be changed before starting the therapy. Implementation Press the Pulse button to open the Ultrasound Parameters window. Pressing Water bath button By pressing the Water bath button and confirming with OK, the ultrasound head temperature monitoring is modified for therapy in a water bath. 15

22 Quick operating instructions Water bath treatment If at the end of the therapy an additional treatment with the same ultrasound programme will be carried out, after adjusting the intensity the following message appears: If at the end of therapy the programme will be changed, the function of the water bath button is 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 the ultrasound head may be too high for treatment outside the water bath. This is shown in the status bar by the message Ultrasound head temperature adjustment. The ultrasound head cannot be used while the temperature is adjusting. Once the temperature adjustment of the ultrasound head is complete, the message disappears and the therapy can be continued. 16

23 General instructions 5 SD card SD card User-defined settings and the indications list are saved on the SD card. Note: If the SD card is not inserted, the message No SD card found appears when the Indications, Favourites and Memory buttons are pressed. Deactivate the message as described in Section

24 Description of the selection buttons 6 Note: The following descriptions are all based on the factory settings. Configuration Press 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 Favourites for editing to add the programme to Favourites in memory mode. Programmes Press the button to open the Programmes window. 18

25 Description of the selection buttons 6 Indications Press the button to open the indications menu. Memory Press the button to open the memory list for editing to add the programme to the memory list in memory mode. Saving Press the button to open the screen to save a programme. The Save button can only be pressed from the therapy screen. Back Press the button to go back one screen. Editing Press the button to open the Memory screen to edit the memory list to open the Favourites screen to edit Favourites 19

26 Description of the selection buttons 6 Moving Press the button to move the order of the list upwards by 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 button to scroll one page down the list. Scrolling backwards Press the button to scroll one page up the list. 20

27 Description of the selection buttons 6 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 changes are applied by pressing the button. 21

28 Screenshot of the therapy screen 7 22

29 Description of the screen elements and buttons Screen elements Title bar The title bar shows the current ultrasound therapy programme. Status 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. Parameters Shows the active ultrasound head. Pulse Shows the operating mode selected. 23

30 Description of the screen elements and buttons Screen elements Operating mode Pulse ratio Pulse frequency Graphic view of the operating mode continuous or pulsed Pulsed operating mode showing the pulse ratio (1:2 here) and the pulse frequency (50 Hz here). Depth effect The bar graph shows the current frequency ratio of 0.8 MHz (800 khz) to 2.4 MHz as a percentage. In this example: 25% 2.4 MHz 75% 0.8 MHz (800 khz) For further explanation please consult the Therapy Manual. Adjusting frequency ratio Adjust the percentage frequency ratios of 2.4 MHz to 0.8 MHz using the right hand regulator. 24

31 Description of the screen elements and buttons Screen elements Coupling The coupling is shown digitally as a percentage. Important: 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 coupling value and when the coupling is sufficient the therapy will continue. Bar graph Shows the currently specified intensity. 25

32 Description of the screen elements and buttons Buttons Note: If the Pulse button is activated during therapy, the therapy will be interrupted, the intensity returns to zero and the therapy time is set to the standard value. Note: Only the parameters that are shown in the pulse window can be changed. Activating the Pulse button When the Pulse button is activated, the Ultrasound Parameters window is opened. Ultrasound parameters The ultrasound mode can be selected here and the ultrasound head can be switched to therapy in a water bath. 26

33 Description of the screen elements and buttons Buttons Selecting the mode Press the two arrow buttons to 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 100 Hz. Water bath Press the button to switch the ultrasound head temperature monitoring to therapy in a water bath. 27

34 Description of the screen elements and buttons Buttons Saving Press the button to save the modified parameters. Cancelling changes Press the button to reject changes made. 28

35 Indications menu 9 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 circle. 29

36 Indications menu 9 Selecting by symptoms After selecting the desired body region (shoulder in this example) the Indications window opens showing 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 another window opens showing detailed symptoms. Select the detailed symptoms by clicking on the relevant row (painful tendinous insertion sites and tendons in this example). 30

37 Indications menu 9 Therapy 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 therapy screen with the programme. 31

38 Saving a modified programme 10 As described in the previous sections, the programme parameters can be separately modified and saved. Selecting the programme Changing the parameters The changes are displayed on the screen. 32

39 Saving a modified programme 10 Opening the memory list Press the button to open the screen to enter the programme 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 enter the programme name. Note: When entering a custom programme name, the name in the input field must first be deleted. 33

40 Saving a modified programme Favourites Saving a programme 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 space in the list. F: Favourites 00: Programme number in the list 34

41 Saving a modified programme Memory Saving a programme in the Memory Press the button to open the Memory. Adding the programme to the Memory Press the button to add the programme to the Memory. The programme is automatically saved in the first free space in the list. S: Memory 00: Programme number in the list 35

42 Retrieving and editing favourites and memory Retrieving favourites The individual saved programs 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. Selecting therapy Select the desired programme by pressing on the appropriate row. 36

43 Retrieving and editing favourites and memory Editing favourites Editing Favourites Press the button to open the Edit Favourites screen. Selecting the programme Select the programme to be edited by clicking on the appropriate row. Changing sequence Activate the appropriate arrow keys to move the programme up or down in the sequence. 37

44 Retrieving and editing favourites and memory Editing favourites Deleting a programme Pressing the button triggers the security question Delete. Press the button to delete the programme. Press the button to keep the programme. 38

45 Retrieving and editing favourites and memory Retrieving and editing memory Selecting Memory Pressing 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 exactly to those used to edit Favourites that were described in detail in the preceding section. 39

46 Indications 12 Indications for orthopaedics, surgery, traumatology, rheumatology Vertebral pain syndrome, e.g., cervical syndrome Anyklosing spondylitis (only during inflammation-free periods) Joint diseases Rheumatoid arthritis (if heat treatment is indicated) Joint degeneration Periarthropathy Epicondylopathy Tendinosis, periostitis, heel spurs Achillodynia Scars, contractures, Dupuytren s contracture Posttraumatic disorders Fractures (particularly with delayed callus formation) Other indications Bronchial asthma Rhinopathy Persistent cervical spine complaints after whiplash injuries with repetitive blocking Headaches Earaches Postherpetic neuralgia Functional disorders of the stomach and duodenum Pelvipathy Functional complaints of the pelvis minor 40

47 Contraindications 13 General contraindications Diseases in which heat should not be applied, e.g., acute inflammatory diseases Diseases in which mechanical forces are contraindicated, e.g., phlebothrombosis, haemorrhagic diathesis 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 regulation disorders After treatment with ionising radiation Epiphyseal plates and lines Tumours Do not use over electronic pacemakers Metal implants and endoprostheses There are no longer any concerns about dynamic ultrasound application in low doses. 41

48 Explanation of symbols 14 In the Operating Instructions, this symbol stands for danger. Follow directions in the Operating Instructions at all times.! In the Operating Instructions this symbol stands for Caution with regard to possible material damage. Follow Operating Instructions Manufacturer Serial number Type BF (as per IEC 601-1): Degree of protection against electric shock. Use on hearts is prohibited. The device is Class II (IEC) or double-insulated. 42

49 Warnings 15 Do not conduct ultrasound therapy on patients with implants or any other implanted electronic device unless the risk has been assessed and found to be negligible. Patients must not be connected to a radio-frequency surgical device at the same time. This may result in burns. Operation of the ultrasound device in the vicinity (e.g., within 1 m) of strong electromagnetic fields (e.g., tomographs, X-ray or diathermy devices) may interfere with the operation of the device. Please maintain a safe distance of several metres. Handle the ultrasound head carefully as rough treatment 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 disinfectants after use. The use of coupling agents other than the special ultrasound gel Sono plus may damage the ultrasound head. We recommend Sono plus by Zimmer MedizinSysteme GmbH. This device is exclusively for use by qualified medical personnel. This device may cause malfunctioning in or may interfere with the operation of devices in its vicinity. It may be necessary to take action to avoid interference such as using a different alignment, moving the device or shielding it. 43

50 Technical Information General Operating voltage Power consumption Protection class Mains fuse Applied part Dimensions Weight Transport Operational environment Storage V, 220 V / 50/ 60 Hz max. 60 VA II 2 x 3.15 A T Type BF 322 mm x 234 mm x 130 mm 2.1 kg in original packaging only +10 C to + 40 C, 30% to 75% rel. humidity, hpa +10 C to + 50 C, 10% to 90% rel. humidity, hpa 44

51 Technical Information Specific Ultrasound heads Frequency 800 khz (0.8 MHz) and 2.4 MHz Small ultrasound head 1 cm², ERA = 1.1 cm² at 800 khz (0.8 MHz), 0.5 cm² at 2.4 MHz Maximum output Intensity steps 1 W at 800 khz (0.8 MHz), 0.5 W at 2.4 MHz 0.1 to 1 W/cm² eff. in steps of 0.1 W / cm² Large ultrasound head 5 cm², ERA = 2.3 cm² at 800 khz (0.8 MHz), 4 cm² at 2.4 MHz Maximum output Intensity steps 7 W at 800 khz (0.8 MHz), 10 W at 2.4 MHz 0.1 to 3 W/cm² eff. in steps of 0.1 W / cm² Accuracy < ± 20 % (This value represents the legally permissible value required by law, and not the actual accuracy level for each device) Ultrasound modes Replacement parts 1. Continuous ultrasound 2. Pulsed ultrasound, adjustable pulse frequencies: 20 Hz, 50 Hz, 100 Hz Duty factor: 1 : 1, 1 : 2, 1 : 3, 1 : 5, 1 : 10 Ultrasound heads are factory-calibrated and can be easily replaced. 45

52 Cleaning Disinfection 17 Housing Clean housing with standard alcohol-free plastic cleaner. Disinfect the housing with standard alcohol-free disinfectant suitable for plastic. Screen Clean the screen with standard alcohol-free plastic cleaner. Disinfect the screen with standard alcohol-free disinfectant suitable for plastic. Ultrasound heads Clean the ultrasound heads with tap water. Disinfect the ultrasound heads with standard alcohol-free disinfectant suitable for plastic.! Do not use cleaning agents containing alcohol. 46

53 CE Marking 18 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 Sono is rated in Class IIb according to Annex IX of the Directive. Soleo Sono has been developed, manufactured and tested under the ISO quality management system. 47

54 Contents on delivery Accessories 19 Contents on delivery Soleo Sono 1 variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 1 storage tray, right 1 storage tray, left 1 mains cable 2 touch pens Accessories Item No Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 4101 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 13 mm 118 Mains cable Storage tray, right Storage tray, left 6 Sono plus, 1 bottle 48

55 Safety and maintenance 20 Soleo Sono is produced in accordance with the safety requirements of EN Zimmer MedizinSysteme as the manufacturer can be responsible for the safety and reliability only in the following circumstances: if the device is operated from an approved earthed wall socket and the electrical installation conforms to DIN VDE 0100 Part 710 if the device is operated in accordance with the Operating Instructions if extensions, 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 it before every use check the ultrasound head, cables and connectors for damage (such as cracks) that could adversely affect the safety of the device the device must be operated by appropriately trained personnel only disconnect the device from the power supply immediately if it is exposed to liquids the unit is not designed for use in explosive or inflammable environments The device does not contain any parts that must be maintained or repaired by the operator. Technical safety checks Soleo Sono does not require technical safety checks. National laws and regulations must be observed when installing and operating Soleo Sono. General note Store the operating instructions so they are accessible to operators of the device at all times. Access must be available for inspection authorities at any time. 49

56 Functional test 21 Soleo Sono runs a self-test that checks all internal components after it is switched on. An error message is shown in case of faults. An extended functional test can also be run as described below. These tests should be run once a month or if there is any doubt about the operational reliability of the device. Select ultrasound head and cover the ultrasound head with gel. The coupling display must show over 90% at low power and at the start of therapy. Run the test consecutively using both ultrasound heads. Then clean ultrasound heads. 50

57 Error messages Troubleshooting Disposal 22 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 confirm with OK. Error The screen shows: In some cases the error can be cleared after switching the device off, waiting five seconds and switching it on again. If this does not work, contact customer service. Customer service is reached through your authorised sales representative or by contacting the head office in Neu-Ulm. The device must be sent to the factory in the original packaging only. Head office Zimmer MedizinSysteme GmbH Junkersstraße 9 D Neu-Ulm Tel Fax Disposal The device must be disposed of by an approved disposal company and must not be discarded with household or special waste. 51

58 Manufacturer's EMC declaration 23. Medical electrical devices such as Soleo Sono are subject to special precautions with regard to electromagnetic compatibility (EMC) and must be installed and commissioned in accordance with the EMC advice given in the operating instructions and accompanying documents. Portable and mobile RF communications devices (such as mobile telephones) may interfere with medical electrical devices. Soleo Sono should only be operated with the original mains cable specified in the list of contents delivered. The use of accessories other than those specified may result in increased emissions or decreased immunity of the device. Guidance and manufacturer's declaration electromagnetic emissions The Soleo Sono device is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo Sono should assure that it is used in such an environment. Emissions tests Compliance Electromagnetic environment guidance RF emissions 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 CISPR 11 Harmonic emissions IEC Voltage fluctuation emissions and flicker IEC Table 201 as per EN : Class B Class A Complies The Soleo Sono device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the device should be monitored to verify normal operation in the configuration in which it will be used. 52

59 Manufacturer's EMC declaration 23 Guidance and manufacturer's declaration electromagnetic immunity The Soleo Sono device is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo Sono device should ensure that it is used in such an environment. Immunity tests IEC test level Compliance level Electromagnetic environment - Guidance Electrostatic discharge (ESD) IEC ± 6 kv contact ± 8 kv air ± 6 kv contact ± 8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC ± 2 kv for mains power lines ± 1 kv for input/output lines ± 2 kv for mains power lines Not applicable The quality of the supply voltage should correspond to a typical business or hospital environment. Surge IEC ± 1 kv differential 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 voltage should correspond to a typical business or hospital environment. <5% UT (>95% dip in UT for 0.5 cycle) 40% UT (>60% dip in UT for 5 cycles) <5% UT (>95% dip in UT for 0.5 cycle) 40% UT (>60% dip in UT for 5 cycles) Mains power quality should be that of a typical commercial or hospital environment. If the user of the Soleo Sono requires continued operation during power mains interruptions, it is recommended that the Soleo Sono be powered from an uninterruptible power source. 70% UT (>30% dip in UT for 25 cycles) 70% UT (>30% dip in UT for 25 cycles) <5% UT (>95% dip in UT for 5 sec) <5% UT (>95% dip in UT for 5 sec) Power frequency (50/60 Hz) magnetic field IEC A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the AC mains voltage prior to application of the test level. Table 202 as per EN :

60 Manufacturer's EMC declaration 23 Significant performance characteristics of the Soleo Sono are: interference-free delivery of ultrasound, as well as interference-free operation of all functions with the parameters set. Guidance and manufacturer's declaration electromagnetic immunity The Soleo Sono device is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo Sono device should ensure that it is used in such an environment. Immunity tests IEC test level Compliance level Electromagnetic environment - Guidance Conducted RF IEC Radiated RF IEC Vrms 150 khz 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 be used no closer to any part of Soleo Sono, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d= 1.17 P d= 0.35 P for 80 MHz to 800 MHz d= 0.7 P for 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range b. Interference may occur in the vicinity of equipment which is marked with the following symbol: NOTE 1 At 80 Hz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 54

61 Manufacturer's EMC declaration 23 a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location where the Soleo Sono device is used exceeds the applicable RF compliance level above, the Soleo Sono device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary such as re-orienting or relocating the Soleo Sono device. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the Soleo Sono device The Soleo Sono device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or user of the Soleo Sono device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device, as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 khz to 80 MHz d= 1.17 P 80 MHz to 800 MHz d= 0.35 P 800 MHz to 2.5 GHz d= 0.7 P For transmitters rated at a maximum output power which is not listed above, the recommended separation distance d in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. We reserve the right to make changes. 55

62 Soleoline Operating Instructions PL GB / Version 2 / 03/2011 / Right of modifications reserved Zimmer MedizinSysteme GmbH Junkersstraße 9 D Neu-Ulm Tel Fax export@zimmer.de