User Manual - Zimmer USA · Fig. 3 Soleo Sono Rear view of device Switch and connector sockets 11 Connector for mains cable 13 On/off switch 12 Fuse holder for mains fuse 14 Socket

User Manual

Soleoline

Soleo Sono

USA

Soleo Sono

Front view of device

Fig. 1

Selection and control elements 1 Intensity regulator 4 Screen 2 Frequency ratio regulator 5 Touch pen in holder 3 Slot for ultrasound head 6 SD card slot Fig. 2

Screen readouts 7 Status bar 9 Title bar 8 Navigation bar 10 Buttons on the screen

1 2

3

4

5

3

6

9

8

10

7

Fig. 3

Soleo Sono Rear view of device

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.

11

12

(15*) (16*) 14 (17*)

13

Contents

Soleo Sono

Front view of device Selection and control elements/screen readouts

Rear view of device

Switch and connector sockets

Page

1. Indications 1

2. Contraindications and Cautions 2

3. Warnings 4

4. Soleoline – Summary / Soleo Sono 6

5. Fitting the cables, Starting the system 7

6. Configuration 6.1 General 8 6.2 Ultrasound therapy 14 6.3 Maintenance 15

7. Quick operating instructions 16 7.1 Water bath treatment 20

8. General instructions – SD card 22

8. Description of the selection buttons 21

10. Screenshot of the therapy screen 27

11. Description of the screen elements and the buttons 11.1 Screen elements 28 11.2 Buttons 31

12. Indications menu 34

13. Saving a modified program 37 13.1 Fast Path 39 13.2 Memory 40

14. Retrieving and editing Fast Path and memory 14.1 Retrieving Fast Path 41 14.2 Editing Fast Path 42 14.3 Retrieving and editing memory 44

Contents Page

15. Explanation of symbols 45

16. Technical Information 16.1 General 46 16.2 Specific 47

17. Cleaning, Disinfection 48

18. Contents on delivery, Accessories 49

19. Safety and Maintenance 50

20. Functional test 51

21. Error messages, Troubleshooting, Disposal 52

22. Manufacturer's EMC declaration 53

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 06.06.12.

U.S.A. Federal Law restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

1

Indications

1

Indications for use

• Relief of pain, muscle spasms and joint contractures • Relief of pain, muscle spasms and joint contractures that may be

associated with: o Adhesive capsulitis o Bursitis with slight calcification o Myositis o Soft tissue injuries o Shortened tendos due to past injuries and scar tissues

• Relief of pain, muscle spasms and joint contractures resulting from: o Capsular tightness o Capsular scarring

2

Contraindications, Cautions

2

Precautionary Definitions

The precautionary instructions found in the section 2 and 3 and throughout the manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definition of these symbols are as follows:

Caution

Text with “Caution” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.

Warning

Text with “Warning” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage.

3

Contraindications, Cautions

2

Contraindications

• This device should not be used on any patient with obtuned reflexes or any area that has significant diminished pain sensitivity or heat sensitivity.

• This device should not be used for symptomatic local pain relief unless etiology is established or unless pain syndrome has been diagnosed.

• This device should not be used over or in a region of tumor/malignancy. • This device should not be used when open wounds are present in the

treatment area. • This device should not be used directly over the portion of the spinal cord

that is no longer protected by bone following a laminectomy. • This device should not be used on patients suspected of carrying serious

infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers.

• This device should not be used over or near bone growth centers until bone growth is complete.

• This device should not be used over a healing fracture. • This device should not be used over the thoracic area of any patient that

has a cardiac pacemaker of any kind. • This device should not be used over the reproductive organs. • This device should not be used over or applied to the eye. • This device should not be used over the abdomen, pelvic or lumbar

regions of pregnant or potential pregnant patient. • This device should not be used on ischemic tissues in individuals with

vascular disease where the blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result.

Metal implants and endoprostheses There are no longer any concerns about dynamic ultrasound application in low doses.

Cautions

• Before each use, inspect the ultrasound heads for cracks, which may allow the ingress of conductive fluid

• Over an area of the spinal cord following: o Laminectomy, i.e., when major covering tissues have been removed o Over anesthetic areas o On patients with hemorrhagic diatheses

4

Warnings 3.1 General

3

• U.S.A. Federal Law restricts this device to sale by or on the order of a

practitioner licensed by the law of the State in which he/she practices to use or order the use of the device.

• Do not use the device in wet rooms (hydrotherapy) or balneotherapy rooms.

• Do not leave patients unattended during treatment. • 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.

• Make certain that the unit is grounded by connecting only to a grounded electrical service receptacle conforming to the applicable national and local electrical codes.

• Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available, as well as the indications, contraindications, warning and precautions. Consult other resources for additional information regarding the application of electrotherapy and ultrasound therapy.

• To prevent electrical shock, disconnect the unit from the power source before attempting any maintenance or cleaning procedure

• 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.

• Handle, clean and dispose of components and accessories that have come in contact with body fluids according to national, local and facility rules, regulations and procedures

5

Warnings 3.2 Ultrasound therapy

3

Ultrasound therapy

• Caution: Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy.

• 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. • Use a coupling agent which is intended for ultrasound treatment and has

high electrical conductivity. • Use a coupling agent which is a cleared medical device on the US

market.

6

Soleoline – Summary Soleo Sono

4

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: The operation of Soleo SonoStim and Soleo Galva is described in a separate

set of operating instructions. What are the advantages 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 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).

7

Fitting the cables Starting the system

5

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

Switch on the device using the rocker switch (13).

Note: All buttons, menus and submenus are activated directly on the screen by

touching it or using the touch pen.

8

Configuration 6.1 General

6

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.

9


6

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 to open the

drop-down menu to select the language.

The language is selected by pressing on the appropriate row.

10


6

Start settings Configuration options for the program start settings:

Press the arrow button to open the drop-down menu to select the program 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.

11


6

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.


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.

12

Configuration

6.1 General

6

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.

13


6

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.

14

Configuration 6.2 Ultrasound therapy

6

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.


15

Configuration 6.3 Maintenance

6

Maintenance

Activate the menu

to open the ‘Maintenance’ screen.

The maintenance programs 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 MedizinSystemes technicians or technicians trained by Zimmer MedizinSystems only.

16

Quick operating instructions

7

Starting the program

Press the button to open the ‘Program’ screen. The program is selected here.

Soleo Sono program

There are 9 different programs available in Soleo Sono.

17


7

Selecting the program

Select the desired ultrasound therapy program by pressing on the appropriate row (here US 01).

Therapy screen After selecting the ultrasound therapy program, the therapy screen opens.

Note: Check that the information shown on the Parameter button (here 5 cm2)

matches the ultrasound head connected before starting therapy.

18


7

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.

19


7

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.

20

Quick operating instructions 7.1 Water bath treatment

7

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.

21

Quick operating instructions 7.1 Water bath treatment

7

If at the end of the therapy an additional treatment with the same ultrasound program will be carried out, after adjusting the intensity the following message appears:

If at the end of therapy the program 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.

22

General instructions SD card

8

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 21.

23

Description of the selection buttons

9

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 Program window.

Fast Path

Press the button • to open Fast Path for editing • to add the programme to Fast Path in memory mode.

Programs

Press the button to open the Programs window.

Indications

Press the button to open the indications menu.

24


9

Memory

Press the button • to open the memory list for editing • to add the program to the memory list in memory mode.

Saving

Press the button to open the screen to save a program. 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 ‘Fast Path’ screen to edit Fast Path

25


9

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 program 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.

26


9

Close

Press the button to close the Fast Path and Memory programs.

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.

27

Screenshot of the therapy screen

10

28

Description of the screen elements and buttons 11.1 Screen elements

11

Title bar

The title bar shows the current ultrasound therapy program.

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.

29

Description of the screen elements

and buttons 1.11 Screen elements

11

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.

30

Description of the screen elements and buttons 11.1 Screen elements

11

Coupling Important:

The coupling is shown digitally as a 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 coupling value and when the coupling is sufficient the therapy will continue.

Bar graph

Shows the currently specified intensity.

31

Description of the screen elements and buttons 11.2 Buttons

11

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.

32


11

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

Note: The duty cycle of 1:10 only provides comfort heating. 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.

33


11

Saving Press the

button to save the modified parameters.

Cancelling changes

Press the

button to reject changes made.

34

Indications menu

12

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.

35

Indications menu

12

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 (Pain in this example).

Selecting by detailed symptoms

After selecting the symptoms another window opens showing detailed symptoms. Select the detailed regions by clicking on the relevant row (Muscle in this example).

36

Indications menu

12

Therapy information

After selecting the detailed symptoms another window opens showing detailed therapy information and a suggested program.

Selecting the therapy program

Press the

button to open the therapy screen with the program.

37

Saving a modified program

13

As described in the previous sections, the program parameters can be

separately modified and saved. Selecting the program

Changing the parameters

The changes are displayed on the screen.

38

Saving a modified program 13

Opening the memory list

Press the

button to open the screen to enter the program name.

Naming the program

Two options are available for naming a program.

1. Accept the program name in the input field.2. Enter a custom program name. If using a custom name, use the

keyboard to enter the program name.

Note: When entering a custom program name, the name in the input field must first be deleted.

39

Saving a modified program

13.1 Fast Path

13

Saving a program in Fast Path

Press the

button to open Fast Path.

Adding the program to Fast Path

Press the

button to add the program to Fast Path.

The program is automatically saved in the first free space in the list.

F: Fast Path 00: Program number in the list

40

Saving a modified program 13.2 Memory

13

Saving a program in the Memory

Press the

button to open the Memory.

Adding the program to the Memory

Press the

button to add the program to the Memory.

The program is automatically saved in the first free space in the list. S: Memory 00: Program number in the list

41

Retrieving and editing Fast Path and memory 14.1 Retrieving Fast Path

14

The individual saved programs are listed in Fast Path.

From here they can be: 1. retrieved for therapy or 2. edited (sequence changed or deleted).

Selecting Fast Path

Press the

button to open Fast Path.

Selecting therapy Select the desired program by pressing on the appropriate row.

42

Retrieving and editing Fast Path and memory 14.2 Editing Fast Path

14

Editing Fast Path

Press the

button to open the ‘Edit Fast Path’ screen.

Selecting the program

Select the program to be edited by clicking on the appropriate row.

Changing sequence Activate the appropriate arrow keys to move the program up or down in the

sequence.

43

Retrieving and editing Fast Path and memory

14.2 Editing Fast Path

14

Deleting a program Pressing the

button triggers the security question ‘Delete’.

Press the

button to delete the program.

Press the

button to keep the program.

44

Retrieving and editing Fast Path and memory

14.3 Retrieving and editing memory

14

Selecting Memory Pressing the

button to open the Memory.

Selecting therapy Select the desired program by pressing on the appropriate row.

Editing Memory Note:

The following steps to edit the Memory correspond exactly to those used to edit Fast Path that were described in detail in the preceding section.

45

Explanation of symbols 15

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 damage to property.

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.

46

Technical Information

16.1 General

16

Operating voltage 100–240 V, 220 V / 50/ 60 Hz

Power consumption max. 60 VA

Protection class II

Mains fuse 2 x 2 A T

Applied part Type BF

Dimensions 12.7 in x 9.2 in x 5.1 in (322 mm x 234 mm x 130 mm)

Weight 4.6 lbs (2.1 kg)

Transport in original packaging only

Operational environment

+10°C to + 40°C, 30% to 75% rel. humidity, 700–1060 hPa

Storage +10°C to + 50°C, 10% to 90% rel. humidity, 700–1060 hPa

Regulatory Compliance

IEC/EN 60601-1 IEC/EN 60601-1-2 IEC/EN 60601-2-5

47

Technical Information

16.2 Specific

16

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 1 W at 800 kHz (0.8 MHz), 0.5 W at 2.4 MHz

Intensity steps 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), 2.4 cm² at 2.4 MHz

Maximum output 6.9 W at 800 kHz (0.8 MHz), 7.1 W at 2.4 MHz

Intensity steps 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 1. Continuous ultrasound2. Pulsed ultrasound, adjustable pulse frequencies:

20 Hz, 50 Hz, 100 HzDuty factor: 1 : 1, 1 : 2, 1 : 3, 1 : 5, 1 : 10

Replacement parts Ultrasound heads are factory-calibrated and can be easily replaced.

48

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.

49

Contents on delivery Accessories

18

Contents on delivery Soleo Sono Item No. 5345 1 Soleo Sono device 4200 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

65910320 65910310 67250130 65800410 Accessories Item No. 4200 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 4220 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 13 mm 67250130 Mains cable 65910320 Storage tray, right 65910310 Storage tray, left

50

Safety and Maintenance

19

Soleo Sono are produced in accordance with the safety requirements of

IEC 60601-1. Zimmer MedizinSystems 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 • if the device is operated in accordance with the Operating Instructions • if extensions, reconfigurations or modifications are implemented only by

persons authorised by Zimmer MedizinSystems • 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.

51

Functional test

20

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.

52

Error messages Troubleshooting Disposal

21

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 can be contacted through the head office in Irvine, CA.

The device must be sent to the factory in the original packaging only. Head office Zimmer MedizinSystems

25 Mauchly Suite 300 Irvine, CA 92618 www.zimmerusa.com

Disposal The device must be disposed of by an approved disposal company and must

not be discarded with household or special waste.

53

Manufacturer's EMC declaration

22

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 Class B 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.

Harmonic emissions IEC 61000-3-2 Class A

Voltage fluctuation emissions and flicker IEC 61000-3-3

Complies

Table 201 as per EN 60601-1-2:2006-10 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.

54


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 60601 test level Compliance level Electromagnetic environment - Guidance

Electrostatic discharge (ESD) IEC 61000-4-2

± 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 61000-4-4

± 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 6100-4-5

± 1 kV differential mode ± 2 kV common mode

± 1 kV differential mode ± 2 kV common mode



<5% UT (>95% dip in UT for 0.5 cycle) 40% UT (>60% dip in UT for 5 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 0.5 cycle) 40% UT (>60% dip in UT for 5 cycles) 70% UT (>30% dip in UT for 25 cycles) <5% UT (>95% dip in UT for 5 sec)

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.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 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 60601-1-2:2006-10

55


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 60601 test level Compliance level Electromagnetic environment - Guidance

Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3

3 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 surveya, should be less than the compliance level in each frequency rangeb. 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.

56


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

0.01 0.12 0.04 0.07

0.1 0.37 0.11 0.22

1 1.17 0.35 0.7

10 3.70 1.11 2.21

100 11.67 3.5 7.0

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.

SoleolineUser Manual

USA

10 1

01 8

86 U

R 08

12

I V

ersi

on 2

I

Righ

t of m

odifi

catio

n re

serv

ed

Zimmer MedizinSystems25 Mauchly, Suite 300Irvine, CA. 92618800 327 3576949 727 2154 [email protected]

Documents

User Manual - Zimmer USA · Fig. 3 Soleo Sono Rear view of device Switch and connector sockets 11 Connector for mains cable 13 On/off switch 12 Fuse holder for mains fuse 14 Socket