User Manual - Zimmer USA · Soleo SonoStim / Soleo Stim Rear view of device Fig. 3 Switch and...

User Manual

Soleoline

Soleo SonoStim, Soleo Stim

User

Man

ual

Sole

o SonoStim

, Sol

eo Stim

USA

Soleo SonoStim / Soleo Stim

Front view of device

Fig. 1

Selection and control elements 1 Intensity controller channel I 5 Screen 2 Intensity controller channel II 6 Touch pen in holder 3 Alligator clip option 7 SD card slot 4 Slot for ultrasound head Fig. 2

Screen readouts 8 Status bar 10 Title bar 9 Navigation bar 11 Buttons on the screen

1 2

3

4

5

4

7

10

9 11

8

3

6

Soleo SonoStim / Soleo Stim Rear view of device Fig. 3

Switch and connector sockets 12 Connector for mains cable 16 Socket for electrode cable channel II 13 Fuse drawer for mains fuse 17 Socket for 0.8/2.4 MHz ultrasound head 14 On/off switch 18 Socket for electrode cable channel I 15 Socket without function in Soleoline

12

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15 14 16 17 18

Contents


Front view of device Selection and control elements/screen readouts

Rear view of device

Switch and connector sockets

Page 1. Indications 1.1 Electrotherapy 1 1.2 Ultrasound therapy 2

2. Contraindications, Cautions 3 2.1 Electrotherapy 4 2.2 Ultrasound therapy 5

3. Warnings 3.1 General 6 3.2 Electrotherapy 7 3.3 Ultrasound therapy 8

4. Soleoline – Summary 9 5. Fitting the cables, starting the system 5.1 Soleo SonoStim / Soleo Stim 10

6. Configuration 6.1 General 11 6.2 Electrotherapy 17 6.3 Ultrasound therapy 19 6.4 Maintenance 21

7. Soleo SonoStim – Quick operating instructions 7.1 Electrotherapy 22 7.2 Ultrasound therapy 26 7.2.1 Water bath treatment 30 7.3 Combined therapy 32

8. Soleo Stim – Quick operating instructions 36

9. General information –SD card 37

Contents Page 10. Description of the selection buttons 38

11. Electrotherapy – Screenshots of the various therapy screens 44

12. Electrotherapy 12.1 Description of the screen elements 46 12.2 Description of the parameter button 48 12.3 Description of the On/Off time button 50 12.4 Change current form parameters 52 12.5 Change On/Off time parameters 56 12.6 Description of the screen elements and the interference button 59

13. Ultrasound therapy – Screenshot of the therapy screen 60

14. Ultrasound therapy 14.1 Description of screen elements 61 14.2 Description of the parameter button 64 14.3 Description of the Frequency button 67

15. Combined therapy – Screenshot of the therapy screen 68

16. Indications menu 69

17. Saving a modified programme 72 17.1 Fast Path 74 17.2 Memory 75

18. Retrieving and editing fast path and memory 18.1 Retrieving fast path 76 18.2 Editing fast path 77 18.3 Retrieving and editing memory 79

19. Explanation of symbols 80

20. General technical information Soleo SonoStim / Soleo Stim

81

21. Specific technical Information 21.1 Stimulation current 82 21.2 Ultrasound 83

22. Cleaning, Disinfection 84

23. Electrodes 23.1 Use and care 85 23.2 Information about the use of various electrode types 86

Contents Page 24. Contents on delivery, Accessories 24.1 Soleo SonoStim 87 24.2 Soleo Stim 88

25. Safety and maintenance 89

26. Functional test 90

27. Technical safety checks 91

28. Error messages, Troubleshooting, Disposal 92

29. Manufacturer's EMC declaration 94 Valid for Soleo SonoStim, Soleo Stim.

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 16.07.2012

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

1.1 Electrotherapy

1

Indications for use

Indications for Pain Management IFC, Premodulated, Microcurrent, Biphasic Currents

• Symptomatic relief or management of chronic, intractable pain • Post-traumatic acute pain • Post-surgical acute pain

Indications for Medium Frequency, Monophasic Currents, Biphasic Symmetric Currents and High Voltage

• Relaxation of muscle spasm • Increasing local blood circulation • Prevention or retardation of disuse atrophy • Maintaining or increasing range of motion • Muscle re-education • Immediate postsurgical stimulation of calf muscles to prevent venous

thrombosis

2

Indications

1.2 Ultrasound therapy

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 tendons due to past injuries and scar tissues

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

3

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.

4


2.1 Electrotherapy

2

Contraindications

• Powered muscle stimulators should not be used on patients with cardial demand pacemakers.

• Other contraindications are patients suspected of carrying serious infectious disease and or disease where it is advisable, for general medical purposes, to suppress heat or fevers.

• Caution should be used for patients with suspected or diagnosed heart problems.

• Caution should be used for patients with suspected or diagnosed epilepsy.

• Caution should be used in the presence of the following: o When there is a tendency to hemorrhage following acute trauma or

fracture; o Following recent surgical procedures when muscle contraction may

disrupt the healing process; o Over the menstruating or pregnant uterus; and

• Over areas of the skin which lack normal sensation. • This device should not be used for symptomatic local pain relief unless

etiology is established or unless pain syndrome has been diagnosed. Cautions

• Safety of powered muscle stimulators for use during pregnancy has not been established.

• Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. The irritation can usually be reduced by using an alternate conductive medium, or alternate electrode placement.

• Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner.

• Powered muscle stimulators should be kept out of the reach of children. • Powered muscles stimulators should be used only with the leads and

electrodes recommended for use by the manufacturer. • The effectiveness of TENS waveforms is highly dependent upon patient

selection by a person qualified in pain management. • Inspect patient cables and associated connectors before each use

Adverse Effects

• Skin irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators.

• Potential adverse effects with TENS are skin irritation and electrode burns.

5



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

6

Warnings

3.1 General

3

Please note: Never connect two patients to the device in one session!

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

7

Warnings

3.2 Electrotherapy

3

Electrotherapy

• Do not conduct electrotherapy treatment on patients with implants or any other implanted electronic device unless the risk has been assessed and found negligible.

• Patients must not be connected to a radio-frequency surgical device at the same time. This may cause burns under the electrotherapy electrodes. Operation of the electrotherapy device in the vicinity (e.g., within 1 m) of strong electromagnetic fields (e.g., tomographs, X-ray or diathermy devices) may cause oscillations in the output values of the electrotherapy device.

• Please maintain a safe distance of several metres. • The recommended maximal current density for currents that could cause

burns (e.g., galvanic current, diadynamic currents, current with a galvanic component) is 2 mA eff/cm² electrode surface.

• If the current density exceeds 2 mA eff/cm², users must be extremely vigilant during treatment.

• Positioning the electrodes in the vicinity of the chest may increase the risk of cardiac fibrillation.

• When using different electrodes, note that a smaller electrode surface area may result in a higher current density.

• The long-term effects of chronic electrical stimulation are unknown. • Stimulation should not be applied over the carotid sinus nerves,

particularly in patients with a known sensitivity to the carotid sinus reflex. • Stimulation should not be applied over the neck or mouth. Severe

spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airways or cause difficulty in breathing.

• Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias.

• Stimulation should not be applied transcerebrally. • Stimulation should not be applied over swollen, infected, or inflamed

areas or skin eruptions, e.g., phlebitis, Thrombophlebitis, varicose veins, etc.

• Stimulation should not be applied over, or in proximity to, cancerous lesions.

If the intensity control is increased, there may be currents greater than

10 mA eff and voltages greater than 10 V may apply at the outlet sockets.

8

Warnings


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.

9

Soleoline – Summary

4

What is Soleoline?

An ultramodern and innovative range of products with 3 different devices available. Soleo SonoStim An ultramodern and innovative combination device for electrotherapy and ultrasound therapy. Soleo Stim An ultramodern and innovative electrotherapy device. Soleo Sono An ultramodern and innovative ultrasound therapy device.

Note: The operation of Soleo Sono is described in a separate set of instructions. What does the Soleoline do?

Output of monophasic, biphasic and medium frequency currents for nerve stimulation and muscle therapy for mono channel and dual channel operation as well as output of therapeutic ultrasound.

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 combination of electrotherapy and ultrasound therapy in a single system enables the use of the established Combined therapy. The compact design saves room in the practice and is highly suited for use in home visits.

Innovations in Soleoline?

SonoSwing, the innovation in the field of ultrasound therapy: • a single ultrasound head with two frequencies 0,8MHz 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).

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Fitting the cables

Starting the system 5.1 Soleo SonoStim / Soleo Stim

5

Note: The following description of fitting the cables refers to the operation of Soleo

SonoStim / Soleo Stim. Note: There are green arrows on the cables as guides for correct connection with

the device. Electrotherapy When connecting the electrode cable ensure that the green arrow is pointing

downwards when being plugged in. Plug the electrode cable for channel I into the appropriate socket (18). Plug the electrode cable for channel II into the appropriate socket (16). Attach the red alligator clip to the red connector on the electrode cable. Attach the black alligator clip to the black connector on the electrode cable.

Ultrasound therapy When connecting the ultrasound head ensure that the green arrow is pointing

left when being plugged in (when standing at the back of the device). Connect the ultrasound head to the appropriate socket (17).

Connecting the mains cable

Plug the mains cable into the appropriate socket (12) on the device and then plug into the mains socket.

Switching on the device

Switch on the device using the rocker switch (14).

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

touching it or using the touch pen.

11

Configuration

6.1 General

6

Note: The following descriptions always refer to therapy using a single channel and

are based on the factory default settings. Note: Changes to the default settings can only be made from the start screen. Start screen After switching on the device and the self-test, the start screen opens.

Selecting configuration

Press the button to open the configuration menu.

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Configuration

6.1 General

6

Configuration menu

In the configuration menu the factory settings can be changed and individually set. After activation of the configuration menu the ‘Select configuration’ screen is active.

Saving settings

Press the button to save the new settings. Quitting the configuration menu

Press the button to return to the start screen. General settings

The setting options are outlined below. In 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.

13

Configuration

6.1 General

6

Start settings Configuration options for the program start settings:

Press the arrow key to open the drop-down menu to select the program start configurations.

The options are selected by pressing on the appropriate row. Note: This section will determine what screen the unit defaults to when ‘Start’ is

pressed from the ‘Start Display’ screen. Start display Option to choose between 2 start display screens:

Press the arrow key to open the drop-down menu to select the start screen.

The selection is made by pressing on the appropriate row.

14

Configuration

6.1 General

6

Sound To switch the signal sound on and off when activating the control fields:

Press the arrow key to open the drop-down menu to switch sound on and off.

The selection is made by pressing on the appropriate row.

Volume Option to adjust the volume in steps from 1 to 4:

Press the arrow buttons 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:

Press the arrow buttons to adjust the screen brightness.

15

Configuration

6.1 General

6

Screen saver Option to configure the start of the screen saver after 0 to 20 minutes:

Press the arrow buttons to set the time until the screen saver is enabled.

Note: While therapy is running the screen saver function is disabled. Welcome message Option to configure an individual welcome message.

Activate the Welcome message field

to open the screen keyboard to enter a welcome message.

Note: Press for upper case letters and additional symbols.

16

Configuration

6.1 General

6

Setting defaults

Press the button to reset the unit to the factory default settings.

Version

Press the button to open the window with information about the current software version.

Press the OK button to close the window.

17

Configuration

6.2 Electrotherapy

6

Electrotherapy settings

Activate the menu

to open the ‘Electrotherapy configuration’ screen.

The settings required for therapy can be adjusted here.

Time Option to configure a uniform therapy time of 1 to 60 minutes for all programs.

Use the arrow buttons to adjust time to desired setting.

Polarity cycle Option to adjust the polarity reversal time from 10 to 120 seconds.

Use the arrow buttons to adjust time to desired setting.

18

Configuration

6.2 Electrotherapy

6

Frequency Option to adjust the default carrier frequency to 2500 Hz, 4000 Hz or 8000 Hz:

The frequency is selected using both arrow keys.

Note: The device is preset with a default carrier frequency of 8000 Hz. If you modify

the carrier frequency in this menu, the name of programs MF00 to MF04 and PM00 to PM06 will remain with 8000Hz. The programs themselves will work with the frequency selected in this menu.

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Configuration


6

Note: Activation of the ‘Ultrasound Therapy’ menu and the associated settings is

only possible in the Soleo SonoStim version. Ultrasound therapy settings

Press the tab

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:

Note: The threshold is adjusted using both arrow keys.

When coupling drops below the set percentage, an acoustic signal sounds and therapy will pause. The unit’s default setting is 75%.

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Configuration


6

Units Option to configure the units for intensity in a bar graph:

Press the arrow

button to open the drop-down menu to select the desired units for power.

The unit is selected by pressing on the appropriate row.

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Configuration

6.4 Maintenance

6

Updates

Press the tab

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 MedizinSystems technicians or technicians trained by Zimmer MedizinSystems only.

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Soleo SonoStim

Quick operating instructions 7.1 Electrotherapy

7

Note: The following note applies to all therapy forms available in the system.

Changing the therapy time can result in a modification of the effects and the patient must be carefully monitored during treatment.

Starting the program

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

SonoStim program

There are 3 different programmes available in SonoStim. - Electrotherapy - Ultrasound therapy - Combined therapy

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Soleo SonoStim


7

Selecting electrotherapy

Electrotherapy is selected by pressing on the appropriate row.

The following description refers to the electrotherapy program. Selecting current forms group

Select the current forms group by pressing on the appropriate row (here Neuromuscular Electrical Stimulation (NMES)).

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Soleo SonoStim


7

Selecting current form Select the current form by pressing on the appropriate row (here AB 00).

Therapy screen After selecting the current form, the therapy screen opens automatically for

channel I.

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Soleo SonoStim


7

Starting therapy The display in the lower status bar changes from ‘Ready’ to ‘Active’ and the

therapy is started by adjusting the intensity using the intensity controller on the left. The effective current is shown in the bar graph and the therapy time counts down in seconds.

Ending therapy At the end of the therapy time, an acoustic signal indicates that the therapy

has ended, the clock is reset to 00:00, the intensity automatically returns to zero and the bar graph display disappears. The display in the bottom status bar changes from ‘Active’ to ‘Ready’. The therapy time is automatically reset at the end of the therapy.

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Soleo SonoStim

Quick operating instructions 7.2 Ultrasound therapy

7



Selecting ultrasound therapy

Ultrasound therapy is selected by pressing on the appropriate row.

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Soleo SonoStim


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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.

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Soleo SonoStim


7

Setting intensity Adjust the intensity using the intensity controller on the left.

Starting therapy

Press the button to start the therapy.

The display in the bottom status bar changes from ‘Ready’ to ‘Active’ with the start of therapy and the ‘Start’ button changes to ‘Stop’. The intensity setting is shown in the bar graph and the therapy time counts down in seconds. The coupling display is active once the treatment is started.

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Soleo SonoStim


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.

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Soleo SonoStim

Quick operating instructions 7.2.1 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 ‘Parameters’

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.

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Soleo SonoStim

Quick operating instructions 7.2.1 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

If the next therapy treatment will be with a water bath.

Ending therapy in the water bath

Press the button

If the next therapy treatment will not be with a water bath.

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 this is happening. Once the temperature adjustment of the ultrasound head is complete, the message disappears and the therapy can be continued.

32

Soleo SonoStim

Quick operating instructions 7.3 Combined therapy

7



Selecting Combined therapy

Select Combined therapy by pressing on the appropriate row.

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Soleo SonoStim


7


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

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

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Soleo SonoStim


7

Setting intensity of the ultrasound

Adjust the intensity using the intensity controller on the left.

Starting therapy Combined therapy is activated by adjusting the intensity using the intensity

controller on the right.

Setting intensity of stimulation current

The display in the bottom status bar changes from ‘Ready’ to ‘Active’. In the left bar graph, the adjusted ultrasound dose is shown and the coupling display is active. In the right bar graph, the actual current flow is shown. The therapy time counts down in seconds.

Note: With Combined therapy, always ensure that the conducting electrode cable

(anode) is only active on channel I. The second electrode is then the ultrasound head.

35

Soleo SonoStim


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 at the end of the therapy.

36

Soleo Stim

Quick operating instructions

8


Press the button to open the ‘Program’ screen.

Selecting current forms group

Select the current forms group by pressing on the appropriate row (here Neuromuscular Electrical Stimulation (NMES)).

Note: The additional steps required to carry out the therapy are described in more

detail in Section 7.1.

37

General information

SD card

9

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, Fast Path and Memory buttons are pressed. Deactivate the message as described in Section 28.

38

Description of the selection buttons

10

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.

Fast Path

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

Programs

Press the button to open the Programs window.

Indications

Press the button to open the indications menu.

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10

Memory

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

Channel

Press the button to open the channel mode. When the button is pressed different channel mode options can be selected.

Mode Group

Activates Monostim, 1-channel therapy. The exceptions are pre-programmed dual channel currents, e.g. interference currents.

Activates Twinstim, 2-channel therapy. The same 1-channel current form runs on channel 1 and channel 2.

Activates Duostim, 2-channel therapy. Different 1-channel current forms run on channel 1 and channel 2.

Note: Twinstim and Duostim will use one user-defined treatment timer with

independent intensity settings.

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10

Channel Group In Monostim mode, channel 1 or channel 2 can be activated for the desired

therapy.

Activates channel I, channel I is active.

Activates channel II, channel II is active.

Synchronisation group

The surge output is defined here for the Twinstim and Duostim modes. Reciprocating activation: The current forms are started and stopped simultaneously on both channels. The surges are alternate.

Co-contract activation: The current forms are started and stopped simultaneously on both channels. The surges are simultaneous.

Independent activation: The current forms are started and stopped separately on both channels. The surges are independent of one another.

Note: Independent activation can only be activated in Duostim mode.

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10

Press the button to select a different current form for channel I.

Press the button to select a different current form for channel II.

Note: Both buttons are highlighted in channel mode and can only be activated in

Duostim mode. Saving

Press the button to open the screen to save a 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

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10

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 when in the ‘Edit’ screen to delete the highlighted program from the list.

Note: You will be asked if you really want to delete the highlighted program. Scrolling forwards

Press the button to scroll one page down the list.

Scrolling backwards

Press the button to scroll one page up the list.

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10

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.

44

Electrotherapy

Screenshots of the various therapy screens

11

Monostim

Example: Program AB 00 on one channel (I). Twinstim

Example: Program AB 00 on both channels (I and II).

45

Electrotherapy

Screenshots of the various therapy screens

11

Duostim reciprocating

Duostim co-contract

Duostim independent

46

Electrotherapy

12.1 Description of the screen elements

12

Note: The ‘Parameter’ and ‘On/Off Time’ buttons turn into control panels once an

electrotherapy program has been selected. Title bar

The title bar shows the channel mode and the name of the effective current form.

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’.

Effects

Gives an overview of the associated medical effects of analgesia, hyperaemia, relaxation and strengthening of the current form.

Note: If the waveform parameters (pulse time or pause) are changed, the effects of

the current form may also change. The window is therefore no longer visible after a change.

47

Electrotherapy


12

Therapy time

Shows the total therapy time from the

start of therapy.

After starting therapy the remaining time is displayed.

Bar graph of intensity

Shows the currently specified intensity. In CC mode:

display in mA eff or peak. (eff = rms)

In CV mode: display in V peak.

48

Electrotherapy

12.2 Description of the parameters button

12

Parameters

1. Presents the parameters of the current therapy program. 2. Activates ‘Parameters of Current Form’ for modification. A detailed description can be found in Section 9.4. 1.1 Frequency display 1.2 Graphic view of waveform 1.3 Polarity 1.4 CC / CV 1.5 Galvanic component

Note: Parameters 1.3–1.5 cannot be used with all current forms and are therefore

not always displayed. 1.1 Frequency display The frequency modes are shown differently depending on the current form,

e.g.: • single frequency (base frequency)

• variable frequency

Two frequencies with an animated display of the current intermediate frequency as a bar.

49

Electrotherapy

12.2 Description of the parameters button

12

1.2 Waveform Graphic view of waveform.

1.3 Polarity Display of polarity:

• only positive

• only negative

• polarity reverses automatically

Note: If the polarity reverses automatically, the first polarity reversal is for 45

seconds (factory setting) or the time set in the configuration menu. 1.4 CC / CV Indication of constant current or constant voltage.

• constant current

• constant voltage

1.5 Galvanic component

Indication of the galvanic component: • 0%

• 20%

• 50%

50

Electrotherapy

12.3 Description of the On/Off Time button

12

On/Off Time active

Indicates that a On/Off Time is activated and shows the parameters of the effective On/Off Time.

6.0 / 12.0 s 6.0 - rise time and retention time of the On/Off Time phase in seconds 12.0 - pause of the On/Off Time phase in seconds After activation of the On/Off Time window, the On/Off Time parameters can be set separately. For a detailed description see Section 10.5.

Note: If the On/Off Time is activated during therapy, the therapy will be interrupted

and the intensity will be set to zero. The therapy time is stopped. The therapy is restarted for the remaining time by adjusting the intensity.

On/Off Time deactivated

When the On/Off Time is deactivated, the On/Off Time window is shown in minimised form. After activation of the On/Off Time window, the On/Off Time can be activated and the On/Off Time parameters can be set separately. For a detailed description see Section 10.5.

Note: If there is no factory setting for a On/Off Time in a program, this window is not

shown.

51

Electrotherapy

12.3 Description of the On/Off Time button

12

On/Off Time inactive

When the therapy is inactive, the On/Off Time is shown completely in blue.

On/Off Time active

During therapy, the On/Off Time is shown as an animation showing the On/Off Time position.

Synchronisation mode reciprocating

Reciprocating

In two-channel mode the alternating reciprocating On/Off Time mode is shown by the two opposing arrows in the top left corner.

Synchronisation mode Co-contract

Co-contract

In two-channel mode the co-contract On/Off Time mode is shown by the two parallel arrows in the top left corner.

52

Electrotherapy

12.4 Change current form parameters

12

Note: Only the parameters that are shown in the parameter window can be

changed. Note: If the Parameters 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.

Activating the Parameters button

When the Parameters button is activated, the ‘Parameters of Current Form’ window is opened.

Parameters of current form

Adjustable parameters can be changed by the user here: 1. Pulse and pulse pause time of current form and therefore the frequency 2. Galvanic component 3. CC / CV 4. Polarity

The adjustable parameters are shown in blue and the fixed parameters are grey.

53

Electrotherapy


12

Selecting the parameters

The parameters that are to be changed are selected with the

arrow keys.

The parameter highlighted in blue can be changed (impulse time here).

Note: Changes to the pulse and pulse hold time also change the frequency. Changing parameters

Use the arrow keys

to increase or decrease the value within the limits specified in the current form definition.

54

Electrotherapy


12

Galvanic component

Press the

arrow keys to reinforce the current form with a galvanic component or to eliminate the galvanic component.

Switching CC / CV mode

Press the

arrow keys to switch the current form from CC to CV mode and vice versa.

Changing polarity

Press the

arrow keys to change the polarity of the current form.

In +/- mode the polarity inversion will be made automatically every 45 seconds (default value preset in the Configuration Menu).

55

Electrotherapy


12

Saving parameters

Press the

button to save the modified parameters.

Cancelling changes

Press the

button to reject changes.

56

Electrotherapy

12.5 Change On/Off Time parameters

12

Note: If the On/Off Time 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.

Activating On/Off-Time button

When the On/Off Time button is activated, the ‘On/Off-Time Parameters’ window is opened.

On/Off-Time parameters

The On/Off Time parameters can be modified as follows by the user: Surge rise time: 0 s: surge off Shortest rise time: 0.5 s Longest rise time: 60 s Shortest On-Time: 0 s Longest On-Time: 60 s Shortest fall time: 0.2 s Longest fall time: 5 s Shortest Off-Time: 0.2 s Longest Off-Time: 60 s

57

Electrotherapy


12

The duration of the On/Off-Time phase is calculated from the duration of the rise time, On-Time and down time.

Selecting parameters

Select the parameters to be changed using the

arrow keys. 1. Rise time (1.5 s here) 2. On-Time (4.0 s here) 3. Off-Time (12 s here)

The parameter highlighted in blue can be changed (rise time here).

Changing parameters

Use the

arrow keys to increase or decrease the value within the limits specified in the On/Off Time parameters definition.

58

Electrotherapy


12

Saving parameters

Press the


Cancelling changes

Press the

button to reject changes.

59

Electrotherapy

12.6 Description of the screen elements and the interference button

12

Interference parameter window

This parameter window shows the maximum effect. Static with sweep deactivated. Animated with sweep activated.

Animated view Static view

When the parameters window is activated, the ‘Parameters of Current Form’

window is opened. Parameters of current form

Adjustable parameters can be changed by the user here: 1. Base frequency (4000 Hz here) and modulation frequency (10 Hz here).

Adjustable base frequencies: 2500 Hz, 4000 Hz and 8000 Hz

2. Percentage ratio of channel I and channel II intensity (95% here). Adjustable from 0–100% in 5% steps.

Note: The intensity is shown simultaneously for both circuits by the left-hand

adjuster.

60

Ultrasound therapy

Screenshot of the therapy screen

13

61

Ultrasound therapy


14

Title bar

The title bar shows the channel mode and the name of 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

1. Displays data from the connected ultrasound head and the program parameters.

2. Opens the ‘Parameters’ window.

A detailed description can be found in Section 12.2. 1.1 Ultrasound head and size of ultrasound head 1.2 Operating mode / pulse frequency / duty cycle

62

Ultrasound therapy


14

1.1 Ultrasound head Graphic view of the active ultrasound head (large ultrasound head here).

1.2 Operating mode

Duty Cycle Pulse frequency

Graphic view of the operating mode continuous

or pulsed

Pulsed operating mode showing the pulse ratio (1:3 here) and the pulse frequency (20 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: 75% 2.4 MHz 25% 0.8 MHz (800 kHz)

63

Ultrasound therapy


14

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 current specified intensity.

64

Ultrasound therapy

14.2 Description of the parameter button

14

Note:

If the Parameters 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 parameter window can be

changed. Activating the parameter button

When the ‘Parameter’ window 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.

65

Ultrasound therapy


14

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.

66

Ultrasound therapy


14

Saving Press the


Cancelling changes

Press the

button to reject changes made.

67

Ultrasound therapy

14.3 Description of the frequency button

14

Note:

If the Frequency 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.

Adjusting treatment depth

Press the ‘Frequency’ button

to open the Frequency screen.

Adjust the frequency ratios 0.8 MHz to 2.4 MHz using both arrow keys.

68

Combined therapy

Screenshot of the therapy screen

15

Note: The buttons and functions on the ‘Combined’ therapy screen correspond

exactly to the therapy screens for ‘Electrotherapy’ and ‘Ultrasound therapy’ as described in the previous sections. An extensive description of the therapy screen will not be given here.

69

Indications menu

16

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.

70

Indications menu

16

Selecting by indication

After selecting the desired body region (shoulder in this example) the Indication window opens showing various indications in the shoulder region. Select the indication by clicking on the relevant row (Pain Management (Acute) in this example).

71

Indications menu

16

Therapy information

After selecting the detailed indications 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 programme.

72

Saving a modified program

17

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

separately modified and saved. Note: The procedure for saving is similar for all therapy forms. The save procedure

for an electrotherapy program is described below. Selecting the program

Changing the parameters

The change is shown in the title bar (AB 00 – modified).

73


17

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.

74


17.1 Fast Path

17

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

75


17.2 Memory

17

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

76

Retrieving and editing Fast Path and

memory 18.1 Retrieving Fast Path

18

The individual saved programmes 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.

77


memory 18.2 Editing Fast Path

18

Editing Fast Path Press the button to open the ‘Edit Fast Path’ screen.


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.

78


memory 18.2 Editing Fast Path

18

Deleting a program

Pressing the button triggers the security question ‘Delete’.

Press the button to delete the saved program.

Press the button to keep the saved program.

79

Retrieving and editing Fast Path and memory 18.3 Retrieving and editing memory

18

Selecting Memory

Press 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.

80

Explanation of symbols

19

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.

81

General technical information


20

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

50°F to 104°F (+10°C to + 40°C), 30% to 75% rel. humidity, 700–1060 hPa

Storage 50°F to 122°F (+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 IEC/EN 60601-2-10

82

Specific technical Information

21.1 Stimulation current

21

Monophasic

Amplitude: Phase duration: Pause: Polarity:

0-50mA 200µs-1.5ms 0.5ms-10s Positive, negative or alternating

High Voltage

Amplitude: Frequency: Polarity:

0-180V 0-1667Hz Positive, negative or alternating

Micro current

Amplitude: Frequency: Polarity:

0-1mA 0.1-1000Hz Positive, negative or alternating

Biphasic rectangular symmetric

Amplitude: Phase duration: Pause: Frequency: Burst Frequency:

0-100mA 100µs-1ms 0.5ms-10s 0-1667Hz 1-200Hz

Middle Frequency

Amplitude: Carrier Frequency:

0-100mA 2000-8000Hz

Premodulated

Amplitude: Carrier Frequency: Beat Frequency: Sweep low frequency: Sweep high frequency:

0-100mA 2000-8000Hz 1-200Hz 1-100Hz 10-200Hz

Interferential

Amplitude: Carrier Frequency: Beat Frequency: Sweep low frequency: Sweep high frequency:

0-100mA 2000-8000Hz 1-200Hz 1-60Hz 30-200Hz

83

Specific technical Information

21.2 Ultrasound

21

Ultrasound heads Frequency 0.8 MHz (800 kMHz) and 2.4 MHz Small ultrasound head 1 cm² , ERA = 1.1 cm² at 0.8 MHz (800 kMHz), 0.5 cm² at 2.4 MHz Maximum output 1 W at 0.8 MHz (800 kMHz), 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 0.8 MHz (800 kMHz), 2.4 cm² at 2.4 MHz Maximum output 6.9 W at 0.8 MHz (800 kMHz), 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 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

Note: Duty cycle 1:10 only provides comfort heating Replacement parts Ultrasound heads are factory-calibrated and can be easily replaced.

84

Cleaning

Disinfection

22

Housing Clean housing with standard alcohol-free plastic cleaner.

Disinfect 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.

Sponge holders Rinse sponge holders well with water after every treatment.

Disinfect by washing at 95°C or sterilising in an autoclave.

! Do not use cleaning agents containing alcohol.

85

Electrodes

23.1 Use and care

23

All ordinary electrodes that are used in electrotherapy can be connected to the

Soleoline by using isolated lead clips. Most successful are the disposable electrodes from Zimmer MedizinSystems. These electrodes are simple, quick, exact and hygienic. Plate electrodes and rubber electrodes are also available in addition to the disposable electrodes for large surface application. In order to avoid placing the bare plate electrodes directly onto the skin, the electrodes are surrounded by sponge pockets. The sponge pockets must be kept wet at all times during the therapy. Lukewarm tap water is most suitable. To attach the sponge pockets, use the rubber bands. The electrodes need to cling to the body surface with a slight pressure, however pressure marks should not be left by the rubber bands. Electrically, plate electrodes are connected like disposable electrodes, using the electrode lead clips. The clips are connected to the plate electrodes which have been previously placed inside the sponge pockets. After the therapy session, the sponges should be cleaned well with water or with a disinfecting solution. Do not place electrodes on skin injuries. Even minor cracks or injuries are likely to cause burns and the patient will feel the current intensity differently. If this cannot be avoided, use zinc cream to cover sensitive areas.

86

Electrodes

23.2 Information about the use of

various electrode types

23

General note Select and apply electrodes with care. In constant current operation, a good,

even skin contact must be ensured. A reduction in the contact area may result in paraesthesia in patients. Before starting the treatment, the skin must be inspected and cleaned if necessary, e.g., if the patient is sweaty or has applied any cream. Inflamed skin, small wounds or scratches are covered with Vaseline or zinc cream. Particular caution is also advised for recent scarring.

Disposable electrodes

Self-adhering disposable electrodes allow comfortable and quick application. They are also hygienic due to their single use. Three therapeutically sensible sizes allow individual therapy appropriate for the symptoms. Disposable electrodes are particularly well suited to therapy with bipolar currents; for therapy with monopolar pulsed currents or currents with a galvanic component the disposable electrodes should also be cushioned with a moist sponge.

Note: The disposable electrode is intended for single use only and can be disposed of

in household waste. Re-use of disposable electrodes may result in a hazard for the patient.

Rubber electrodes Rubber electrodes are suitable for therapy with bipolar currents; when used for

purely galvanic current, currents with galvanic components or long pulse durations it must be noted that the normal removal of carbon resulting from use causes a reduction in the conductivity.

Tin plate electrodes For therapy with purely galvanic current (galvanisation, iontophoresis) large tin

plate electrodes are suitable.

Sponge holders and sponges

Both rubber and zinc plate electrodes must always have a moist intermediate layer placed underneath. It is recommended to use sponge holders for rubber electrodes and sponges, which should be at least 1 to 2 cm thick, for zinc plate electrodes. Tap water is recommended to moisten the sponges; distilled water is not suitable as it is a poor conductor. Unlike the comfortable self-adhesive disposable electrodes, rubber and zinc plate electrodes must be fixed in place. Velcro or perforated rubber bands are suitable.

87

Contents on delivery

Accessories 24.1 Soleo SonoStim

24

Contents on delivery Soleo SonoStim Item No. 5340 1 Soleo SonoStim device 154 2 electrode cables, incl. 2 red and 2 black alligator clips,

2.90 m long, incl. magnetic clip 4200 1 variable frequency ultrasound head 0.8 and 2.4 MHz, ø 28 mm 65910320 1 storage tray, right 65910310 1 storage tray, left 67250130 1 mains cable 65800410 2 touch pens 65920310 2 test resitances Accessories Item No. 65800410 Touch pen 67250130 Mains cable 65910320 Storage tray, right 65910310 Storage tray, left 65920310 Test resistance Electrotherapy 154 2 electrode cables, incl. 2 red and 2 black alligator clips,

2.90 m long, incl. magnetic clip 68910111 1 pair electrode cables, 2.90 m 31100146 Alligator clip red 31100147 Alligator clip black 16 Disposable electrodes, 135 pairs, small (1 package) 17 Disposable electrodes, 90 pairs, medium (1 package) 18 Disposable electrodes, 45 pairs, large (1 package) 25

Disposable electrodes, 50 pairs, round (1 package)

Ultrasound therapy 4200 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 5 cm2 (28 mm) 4220 Variable frequency ultrasound head 0.8 and 2.4 MHz, ø 5 cm2 (13 mm)

88

Contents on delivery

Accessories 24.2 Soleo Stim

24

Contents on delivery Soleo Stim Item No. 5350 1 Soleo Stim device 154 2 electrode cables, incl. 2 red and 2 black alligator clips,

2.90 m long, incl. magnetic clip 65910320 1 storage tray, right 65910310 1 storage tray, left 67250130 1 mains cable 65800410 2 touch pens 65920310 2 test resitances Accessories Item No. 154 2 electrode cables, incl. 2 red and 2 black alligator clips,

2.90 m long, incl. magnetic clip 68910111 1 pair electrode cables, 2.90 m 31100146 Alligator clip red 31100147 Alligator clip black 16 Disposable electrodes, 135 pairs, small (1 package) 17 Disposable electrodes, 90 pairs, medium (1 package) 18 Disposable electrodes, 45 pairs, large (1 package) 25 Disposable electrodes, 50 pairs, round (1 package) 65800410 Touch pen 67250130 Mains cable 65910320 Storage tray, right 65910310 Storage tray, left 65920310 Test resistance

89

Safety and maintenance

25

Soleo SonoStim / Soleo Stim 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.

90

Functional test

26

Soleo SonoStim / Soleo Stim 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 in all three operating modes as described below.

These tests should be run once a month or if there is any doubt about the

operational reliability of the device. Stimulation current Select program DC 00. Insert test adapter (test Patient).

The display in the bar graph must be completely full at maximum intensity. Run the test consecutively with both channels.

Ultrasound Select ultrasound head and cover the ultrasound head with gel. The coupling

display must show over 90% at low power and at the start of therapy. Run the test consecutively using both ultrasound heads. Then clean ultrasound heads.

91

Technical safety checks

27

National laws and regulations must be observed when installing and operating

the therapy devices Soleo SonoStim and Soleo Stim. General information

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.

92

Error messages

Troubleshooting Disposal

28

Cable check

With stimulation current therapy in continuous current mode: the patient current circuit is broken. This message generally indicates failed electrodes, dirty electrode terminals or a faulty patient fuse. Press OK to clear the message.

Excess current

This refers to an increase above the maximum allowable current. A current increase in continuous mode generally indicates a fault in the device, while a current increase in continuous voltage mode may occur because of a change in the patient resistance (e.g., moist skin). Press OK to clear the message. If the error message appears again, contact customer service.

93

Error messages

Troubleshooting Disposal

28

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.

94

Manufacturer's EMC declaration

29

Medical electrical devices such as Soleo SonoStim / Soleo Stim are subject to special precautions regarding electromagnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in these operating instructions for use and any accompanying documents. Portable and mobile RF communications devices (such as mobile telephones) may interfere with medical electrical devices. Soleo SonoStim / Soleo Stim 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 SonoStim / Soleo Stim is intended for use in one of the electromagnetic environments specified below. The customer or the user of the Soleo SonoStim / Soleo Stim device should ensure that the device is used in such an environment.

Emissions tests Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 2 The Soleo SonoStim / Soleo Stim 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 SonoStim / Soleo Stim 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.

95


29

Guidance and manufacturer's declaration – electromagnetic immunity


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



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) 95% dip in UT for 5 sec)

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) 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 SonoStim / Soleo Stim requires continued operation during power mains interruptions, it is recommended that the Soleo SonoStim / Soleo Stim 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

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29

Fundamental performance characteristics of the Soleo SonoStim / Soleo Stim (stimulation current only) are: interference-free output of stimulation current and ultrasound with the specified parameters and interference-free operation of all functions. Guidance and manufacturer's declaration – electromagnetic immunity


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 SonoStim / Soleo Stim, 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.

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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 device Soleo SonoStim / Soleo Stim is used exceeds the applicable RF compliance level above, the device Soleo SonoStim / Soleo Stim should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the device Soleo SonoStim / Soleo Stim. 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 telecommunications equipment and the Soleo SonoStim / Soleo Stim device

The Soleo SonoStim / Soleo Stim device is intended for use in an environment in which radiated RF disturbances are controlled. The customer or user of the Soleo SonoStim / Soleo Stim device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF telecommunications equipment (transmitters) and the Soleo SonoStim / Soleo Stim 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.

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SoleolineUser Manual

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

User

Man

ual

Sole

o SonoStim

, Sol

eo Stim

Bedienung Soleo Galva SonoStim USA V2Fig. 1Selection and control elementsScreen readoutsFig. 3Switch and connector socketsThe 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:Text with “Caution” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment.Text with “Warning” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage.The volume is adjusted using both arrow keys.BrightnessScreen saverNote:Coupling signalNote:Note:ConfigurationStartFast PathPrograms

ChannelMode GroupMonostimTwinstimStatus barTherapy timeParametersSelecting the parametersChanging parametersSelectingparametersChanging parametersTitle barStatus barParametersDepth effectCouplingBar graphOnly the parameters that are shown in the parameter window can be changed.

Ultrasound parametersSelecting the mode

Selecting the frequencyWater bathSaving

IndicationsOpening the memory listManufacturerOperating voltage0.8 MHz (800 kMHz) and 2.4 MHz6.9 W at 0.8 MHz (800 kMHz), 7.1 W at 2.4 MHzItem No.6580041067250130659103206591031065920310Item No.6580041067250130659103206591031065920310

USA_10101887_GA_SoleoSonoStim_0812_V2

User Manual - Zimmer USA · Soleo SonoStim / Soleo Stim Rear view of device Fig. 3 Switch and...

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Transcript of User Manual - Zimmer USA · Soleo SonoStim / Soleo Stim Rear view of device Fig. 3 Switch and...