PHYACTION 190i Instructions for Use March 1999

Table of contents

INTRODUCTION CHAPTER 1 1.1 1.2 1.3 1.4 1.5

Electrical safety... Explosion safety... Operational safety... Use of the appliance... Medical device directive...

CHAPTER 2 2.1 2.2 2.3 2.4 2.5

4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12 4.13 4.14 4.15

5.1 5.2 5.3 5.4 5.5 5.6

4 4 4 4 4 4 5 5 5

INTRODUCTION COURSE

Introduction... Connection... Control panel... The therapy screen... Setting the treatment parameters... Setting the treatment time... Connecting the ultrasound treatment heads... Combination therapy with another appliance... Setting the ultrasound intensity... Treatment head - patient contact... Treatment memory... Selecting a therapeutic application per indication... Altering the contrast... Starting from stand-by... Switching off...

CHAPTER 5

3 3 3 3 3

DESCRIPTION OF THE CONTROLS

Display... Signal lamps... Rotary knob... Push buttons... Output connectors and sockets on the front... Controls on the bottom at the rear of the appliance... Label on the rear of the appliance... Ultrasound treatment heads... Head holder...

CHAPTER 4

2 2 2 2 2

INSTALLATION

Incoming inspection... Mains voltage... Functional test... Location and transportation... Fitting the head holder...

CHAPTER 3 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9

SAFETY ASPECTS

6 6 6 6 6 7 7 7 8 8 9 9 9 9 9

SYSTEM SETTINGS

Introduction... Selecting the operating language... Presets user... Presets Uniphy... Volume... Sound signal setting...

Table of contents - Instructions for use Phyaction 190

10 10 10 10 10 10

CHAPTER 6 6.1 6.2 6.3 6.4 6.5

CHAPTER 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9

9.1 9.2

INDICATIONS AND CONTRA-INDICATIONS COMBINATION THERAPY OF ULTRASOUND AND ELECTROTHERAPY

Introduction... Reasons for combination therapy... Advantages of combination ultrasound with medium frequency or TENS currents . . Connecting the electrotherapy appliance... Setting order for diagnostic and therapeutic combination therapy... Indications for combination therapy... Contra-indications for combination therapy...

CHAPTER 12 12.1 12.2 12.3 12.4

THERAPEUTIC APPLICATIONS

Indications... 24 Contra-indications... 24

CHAPTER 11 11.1 11.2 11.3 11.4 11.5 11.6 11.7

17 17 17 18 19 20 20 20

Therapeutic applications... 21 Description of the therapeutic applications... 21

CHAPTER 10 10.1 10.2

13 13 13 13 13 14 14 14 16

ULTRASOUND APPLICATION AND TREATMENT PARAMETERS

Introduction... Order of settings for ultrasound therapy... Underwater treatment... Intensity... Handling the treatment head... Visual contact control... Acoustic contact control... Commencing treatment...

CHAPTER 9

11 11 11 12 12

BASIC ULTRASOUND THERAPY INFORMATION

Definition of ultrasound therapy... Generating vibration and tuning the treatment heads... Continuous and pulsed ultrasound... Properties of the ultrasound beam... Distribution and interference of ultrasound in the body... Refraction and reflection of ultrasound... Contact gel... Absorption coefficient, half value depth and penetration depth... Effects of ultrasound therapy...

CHAPTER 8 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8

PROGRAMMABLE MEMORY

Introduction... Operating principle... Saving data... Retrieving data... Deleting data...

25 25 25 25 26 26 26

MALFUNCTION, GUARANTEE, MAINTENANCE

Malfunction... Guarantee and service... Cleaning... Disinfection and sterilization...

Table of contents - Instructions for use Phyaction 190

27 28 28 28

CHAPTER 13 13.1 13.2 13.3 13.4

CHAPTER 14 14.1 14.2

29 29 29 29

ACCESSORIES

Standard accessories phyaction 190... 30 Optional accessories Phyaction 190... 30

CHAPTER 15 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9

TECHNICAL SPECIFICATIONS

Specifications Phyaction 190... Specifications treatment heads... Technical information... Replaceable parts...

EXPLANATION OF SYMBOLS

Symbols in the therapy screen... Contact detection indications... Options in the therapy screen... Symbols in the memory screen... Options in the memory screen... Symbols in the system setting menu... Symbols for messages... Symbols at the front of the appliance... Symbols at the back of the appliance...

DRAWING OF THE DEVICE

Table of contents - Instructions for use Phyaction 190

31 31 31 32 32 32 32 33 33

INTRODUCTION

Congratulations with your new Phyaction! By selecting the Phyaction you are assured of quality, versatility, ease of operation, safety and good service. The Phyaction 190 is suitable for ultrasound therapy. Connected to an electrotherapy appliance it can also be used for combination therapy. The Phyaction 190 offers you also the indication menu. The operating instructions not only describe the operating controls and functions. The theory, application, indications and contra-indications of ultrasound therapy and combination therapy are also dealt with in detail. By placing this user manual in an easily accessible place for all users it can always be used as a reference book. The Phyaction 190 is very easy to operate: clear symbols are used and the functions of the buttons will be immediately obvious. You will notice that you can begin working with the appliance immediately. However, we advise you to thoroughly read the operating instructions so that you are familiar with all of the options which the equipment offers. If you have any further questions or remarks we would be pleased to hear from you. Our physiotherapists are always available. We wish you a great deal of success with the therapy!

UNIPHY BV March 1999

INTRODUCTION

Instructions for use Phyaction 190 - Page 1

CHAPTER 1

SAFETY ASPECTS

1.1 Electrical safety The equipment can only be used in areas with provisions in accordance with current statutory requirements. Pay particular attention to the use of protective earth, otherwise the patient leakage current can rise above the permitted limit for type BF equipment. 1.2 Explosion safety The equipment is not suitable for use in areas where flammable gasses or vapours are present. Therefore, remove the mains plug from the socket before the area in which the equipment is located is disinfected, since some disinfection solutions evaporate and subsequently form an explosive mixture. 1.3 Operational safety - Using the equipment in the vicinity of short wave or microwave equipment can influence the correct operation of the unit. Using this equipment when high frequency surgical equipment is connected to the patient at the same time can result in burning under the electrodes when using it for combinationtherapy. - Patients who have electrical implants (i.e. pacemaker) may only be treated following medical advice. - The equipment is not suitable for use in damp areas. - The equipment may not be disinfected or sterilized. - Whenever the equipment is switched on (using the main switch) the microprocessor checks the entire system for correct operation. - The ultrasound heads, including the cable and the connectors should be checked regularly. In particular attention should be paid to damage to the ultrasound heads through which liquids can enter the ultrasound heads. - The ultrasound heads should be handled carefully, because the properties of the ultrasound heads can alter due to rough handling. - The proper and safe operation of the device can only be guaranteed if it is used with the standard and/or optional accessories as mentioned in these operating instructions (see chapter 14, ACCESSORIES). - In order to safeguard the long-term safety of the device, we advise you to have a technical safety check of the device and the accessories performed at least once every year. 1.4 Use of the appliance The equipment and accessories should only be used by authorized personnel (trained in the application of ultrasound therapy) and in accordance with all instructions included in these operating instructions. The Phyaction 190 is only to be used for providing ultrasound therapy. When connected to an electrotherapy appliance the Phyaction 190 can be used to provide combination therapy. The temperature range for the use of the Phyaction 190 ranges from +10°C to +40°C. The temperature range for storage and transport of the device ranges from -20°C to +70°C. 1.5 Medical device directive This device complies with the essential requirements of the Medical Device Directive of the European Committee (93/42/EEC). For the manufacturers liability see chapter 12 MALFUNCTION, GUARANTEE, MAINTENANCE.

1. SAFETY ASPECTS

Instructions for use Phyaction 190 - Page 2

CHAPTER 2

INSTALLATION

2.1 Incoming inspection Check that the equipment and ultrasound head(s) have not been damaged during transportation and that the accessories are intact and complete (see chapter 14 ACCESSORIES). In the event of damage and/or defect you should inform your supplier. 2.2 Mains voltage Your equipment is suitable for a nominal voltage of 110, 220, 230 or 240 Volt AC, 50-60 Hz. Indicated on the rear of the equipment will be the voltage for which it has been wired. You can not alter this yourself. Carefully check this data before you place the mains plug in the socket. The mains input is on the back of the appliance at the bottom. 2.3 Functional test During production the equipment is tested for electrical safety. Whenever the equipment is switched on, the processor performs an extensive test to ensure that the equipment is operating correctly. In addition you must check whether the display and the indicator lamps are operating correctly. The green lamp indicates that the appliance is connected to the mains supply and that the appliance is switched on. The red lamp illuminates when the safety system has detected a fault which prevents the appliance being used. If the appliance is not operating correctly, then you must not use the equipment and you must contact your supplier. If you can not read or if it is difficult to read the display, then press the second blue button from the right hand and the black button in order to darken the text or the black button if you want to make the text lighter. We recommend that the effectiveness of the ultrasound head be checked regularly in a basin filled with water. 2.4 Location and transportation When you are going to use the equipment for the first time you should first read through chapter 1 concerning SAFETY ASPECTS. The equipment must be set up horizontally and stable. You should ensure that the vents on the underside of the housing are not blocked so that circulation of air is not hindered. Objects must not be placed on the equipment and you must ensure that no liquid enters the equipment. Do not place the device in direct sunlight or on top of a heating system. If desired, you can connect the device to the potential compensating mains. If it is necessary and/or advisable to dispatch the device, we recommend that you use the original packaging to do so. 2.5 Fitting the head holder As standard, a head holder is supplied with each treatment head. Before you use the Phyaction 190 for the first time, we advise you to fix the head holder(s) to the appliance. The ultrasound treatment head can be connected to the appliance easily and in a user-friendly manner into the head holder. At the same time this protects the treatment head against damage by, for example, falling. For a description of fixing the head holder to the appliance please refer to the drawing which you will find in the packing for the head holder.

2. INSTALLATION

Instructions for use Phyaction 190 - Page 3

CHAPTER 3

DESCRIPTION OF THE CONTROLS

On the last page of this operating instruction you will find an illustration of the equipment and the accessories. 3.1 Display The display1 consists of separate picture elements which are controlled by a processor so that you can see text and figures. When you are performing a treatment, the display shows all of the information you require: - The top left section provides information about the parameters which have been set. - The right section provides information about the output power and the degree of contact of the treatment head. This section also gives information about the treatment time. - The bottom line of the display shows the functions of the blue buttons.

Layout of the therapy screen 3.2 Signal lamps On the front, to the right of the display, there are two coloured lamps: - The green lamp2 indicates that the appliance is connected to the mains supply and that the appliance is switched on. - The red lamp3 illuminates when the safety system has detected a fault which prevents the appliance being used. A message appears on the display. See chapter 12 FAULTS, GUARANTEE, MAINTENANCE. The red lamp also illuminates during the self test which is performed after switching on the appliance. The yellow lamps4, beside the output connectors of the ultrasound head, illuminate for 2 seconds as soon as the relevant ultrasound head has been selected. A yellow lamp also illuminates beside an output connector as soon as ultrasound power is emitted. 3.3 Rotary knob On the right-hand side at the front there is a large rotary knob5 with which the intensity peak in Watt/cm2 can be adjusted. When you rotate this knob fully anti-clockwise you will feel a click and it is in the zero position. 3.4 Push buttons - Using the blue buttons 6 a parameter can be selected. This display clearly shows the function of the buttons. - The black buttons or 7 are used to increase or decrease the value of a parameter which you have already selected. - The yellow button8 is used to return to the therapy screen. When the yellow button is depressed for 3 seconds, a screen appears in which the software version number, the release date of the software and the treatment head parameters can be read. - Using the green button9 you can access the special memory function and the indication menu. 20 different treatments can be saved, retrieved or changed. 3.5 Output connectors and sockets on the front - The safety socket10 on the far left is used for connecting the electrode cable during combination therapy. The metallic treatment surface of the ultrasound head forms the other electrode. - The ultrasound head(s) are connected to the two connectors11 on the right. It makes no difference which head(s) you connect to which connector. Two treatment heads can be connected at the same time provided they do not have the same format.

3. DESCRIPTION OF THE CONTROLS

Instructions for use Phyaction 190 - Page 4

3.6 Controls on the bottom at the rear of the appliance The following controls can be found on the rear of the appliance: - The mains input with mains switch12. - The fuse holder13 is located between the mains input and the mains switch. The value of the fuse to be used is stated on the rear of the appliance. - The connector for connecting to the potential equalization busbar14. 3.7 Label on the rear of the appliance The label containing the appliance data15 is located on the rear of the appliance. 3.8 Ultrasound treatment heads You have the choice of two ultrasound treatment heads16 with an ERA (Effective Radiating Area) of either 1 or 4 cm2. The treatment heads can be easily located in the multi-functional head holder17. For each treatment head both 1 and 3 MHz ultrasound can be given. Both treatment heads can be connected to the appliance at the same time. Using the blue button you can select which you want to use. The display indicates which format of treatment head has been selected at that moment. As soon as the Phyaction 190 is switched on using the mains switch or from the stand-by position, or as soon as a treatment head has been selected, the yellow lamp beside the selected head illuminates for 2 seconds on the appliance. Furthermore, each treatment head has a colour indication at two positions: the 4 cm2 treatment head is green and the 1 cm2 is yellow. When the surface of the treatment head makes insufficient contact with the patient this is shown on the screen. The ultrasound power is then automatically turned down so that overheating of the treatment head and subsequent wear is reduced. The treatment time also stops when there is insufficient contact and this starts again as soon as contact is re-established. In this way the set time is actually utilized. Your appliance should always be tuned to the associated treatment heads. When you receive your new appliance your supplier has already tuned the appliance. However, when you purchase a new (another) treatment head, you must also tune your appliance to the new head. Your supplier can give you information about this. 3.9 Head holder For each Phyaction 190 a head holder for each treatment head is supplied as standard. You can fit this to the appliance easily yourself. For a description of fixing the head holder to the appliance please refer to the drawing which is enclosed in the packing for the head holder.

3. DESCRIPTION OF THE CONTROLS

Instructions for use Phyaction 190 - Page 5

CHAPTER 4

INTRODUCTION COURSE

4.1 Introduction This chapter forms a general introduction course for the operation of the equipment. First, we will familiarize you with the basic functions of the equipment. This is followed by a number of more specific points. The various therapy forms and their parameters will be discussed in separate chapters. We advise you to read this chapter thoroughly in order to become conversant with the many possibilities of your new equipment. When you are going to use the equipment for the first time, you should firstly read through chapter 1 SAFETY ASPECTS and 2 INSTALLATION. Set up the equipment so that it is horizontal and stable. Ensure that the perforated sections of the casing are not covered up, otherwise air circulation will be hindered. Objects must not be placed on the equipment and you must ensure that no liquid enters the equipment. Fix the head holder(s) to the appliance. 4.2 Connection Firstly, connect the appliance to the socket via the mains lead which is supplied. The mains input is located on the rear of the appliance at the bottom. Then connect the appliance to the potential equalization busbar. Then turn the mains switch on. This is located on the rear of the appliance at the bottom next to the mains input. The green lamp illuminates and the processor begins an extensive test of the appliance. You will see this on the display and hear that the fan is being tested. The processor can not complete the test procedure if a fault is detected. In this case a message appears on the display and you have to switch off the appliance using the mains switch and switch it on again. If the relevant message appears again you should inform your supplier. See chapter 12 FAULTS, GUARANTEE, MAINTENANCE. 4.3 Control panel Your Phyaction is now ready for use. From now on all operations will be conducted from the control panel using the coloured buttons and knob. The buttons respond to light pressure from your finger. After switching on, the therapy screen appears on the display. From this screen you can select the ultrasound parameters by pressing one of the blue buttons. Each time you press a button a short beep can be heard which indicates that the processor has received your command correctly. When you give a command which cannot be performed then the appliance indicates this with a longer beep. This occurs, for example, when you want to change the ultrasound frequency while the intensity regulator is in the zero position. 4.4 The therapy screen After the appliance is switched on, the therapy screen appears on the display. From this screen you can set the various treatment parameters.

The therapy screen When the memory screen is on the display you can access the therapy screen by pressing the yellow button. 4.5 Setting the treatment parameters When you want to change the parameters, press the button which belongs to the parameter which you want to change. For parameters where you only have the choice of two options, such as the head selection ( 1 or 4 cm2 treatment head) parameter and ultrasound frequency parameter (1 or 3 MHz), the parameter is immediately set after pressing the relevant blue button once. The selected parameter can be seen in the top left section of the screen. For parameters where you have more than two options, such as the duty-cycle or the treatment time, the value of the selected parameter begins to flash after pressing the relevant blue button. Using the black buttons 4. INTRODUCTION COURSE

Instructions for use Phyaction 190 - Page 6

and the parameter value can be increased or decreased. If a parameter is not changed after 10 seconds the flashing automatically stops. The value of a parameter changes more rapidly the longer you keep the black button depressed. 4.6 Setting the treatment time When you press the blue button with the clock symbol once when setting the treatment time, the minute value starts to flash. By pressing again, the seconds start to flash. At the moment that the value flashes you can use the black buttons to set the required treatment time. The maximum treatment time which can be set is 30 minutes. The minutes can be set continuously, the seconds in steps of five. For ultrasound therapy the timer only begins to count down as soon as you turn up the relevant intensity regulator. When the treatment head makes insufficient contact with the patient during the treatment, the timer stops. When the treatment time has elapsed you will hear a beep. The output automatically returns to zero and you should turn the intensity regulator back. If you start a treatment by turning up the intensity regulator while no treatment has been set, the clock symbol flashes in the output screen. In that case the treatment is only ended when the intensity regulator is turned back to zero. 4.7 Connecting the ultrasound treatment heads It is possible to connect two ultrasound treatment heads with different formats to the appliance at the same time. By using the blue button you can then select a specific ultrasound treatment head for which the yellow lamp beside the output connector of the selected head illuminates for 2 seconds. The selected head is shown on the display and the ERA of the head is shown next to the symbol. When you only connect one head to the appliance you can do this via either of the two connectors. The appliance detects which head is connected and shows this immediately on the display. If you purchase a new (another) treatment head, your appliance has to be tuned to this treatment head. Your supplier is responsible for the tuning. If the tuning process is not performed, your appliance will indicate that the appliance has not been tuned to the treatment head. However, if for example your appliance has been tuned to a large treatment head and you take a large treatment head from another Phyaction 190, then the appliance will not indicate this. The result can be that the insufficient contact detection works poorly or not at all, or that the output power deviates from that which is shown on the display. If you are in possession of more than one appliance you must therefore ensure that you do not interchange the treatment heads of the appliances. You can check which head belongs to which appliance by pressing the yellow button for 3 seconds. In the middle of the screen which then appears, you will see the treatment head symbol with a statement of the ERA on which treatment head(s) the appliance has been tuned. After this symbol there are 20 figures. If these figures correspond exactly with the figures on the treatment head label then this treatment head belongs to that appliance. If they do not correspond, you are using a treatment head which does not belong to that appliance. If the middle screen is completely empty then the appliance has not been tuned to any treatment head and we advise you to inform your supplier. The ultrasound head(s) can be left connected to the appliance when the appliance is not in use. The different messages which can appear on your screen when an error has been made during connection of one or two treatment heads are discussed in section 12.1. 4.8 Combination therapy with another appliance When you want to use the Phyaction 190 in combination with the Phyaction 180, you must connect the current input socket of the Phyaction 190 with the left or right socket of the selected channel of the Phyaction 180. The one which you select depends on the eventual polarity of the electrode. The electrode which you are going to use for combination therapy is connected to the other socket of the channel being used on the Phyaction 180.

4. INTRODUCTION COURSE

Instructions for use Phyaction 190 - Page 7

Connection of the Phyaction 190 to a Phyaction 180 is done by means of a special connecting cable (Uniphy art. no. 13162100) with 2 safety plugs. When you want to use the Phyaction 190 in combination with an appliance from the Phyaction 780 series, you must connect the current input socket of the Phyaction 190 with the left or right socket of the selected channel of the Phyaction 782/787. The one which you select depends on the eventual polarity of the electrode. The electrode which you are going to use for combination therapy is connected to the other socket of the channel being used on the Phyaction 782/787. When you want to use the Phyaction 190 in combination with another appliance which is not from the Phyaction 780 series, we advise you to contact your supplier who will discuss the possibilities with you. In that case, the electrotherapy appliance to be used must be of the BF type. 4.9 Setting the ultrasound intensity Using the intensity regulator you can set the ultrasound intensity peak in Watt/cm2. The maximum intensity which can be set, called the intensity peak, is dependent on the duty-cycle and frequency which has been selected. The intensity (output power) range is as follows: - continuous ultrasound at 3 MHz: 0-1.5 W/cm2 - continuous ultrasound at 1 MHz: 0-2.0 W/cm2 - pulsating ultrasound at 1 and 3 MHz: 0-3.0 W/cm2 You can see the value of the set intensity peak in the top left section of the display. As soon as contact is made with the patient, the output power (Peff) appears on the right of the display. The output power is the energy which is passed to the patient through the treatment head for each unit of time. This is dependent on the intensity peak which has been set, the effective surface area of the head, the duty-cycle and the degree of contact (see section 8.4). During application the intensity can be re-adjusted as required. When the treatment head makes sufficient contact with the patient the yellow lamp illuminates beside the ultrasound output sockets of the appliance. However, as soon as there is insufficient contact the yellow lamp goes out and the ultrasound power is turned down. The timer stops. After contact has been re-established the timer begins to run again. See section 4.10. During the treatment it is not possible to change ultrasound parameters, other than the time and the intensity, without turning the intensity to zero first. 4.10 Treatment head - patient contact The degree of contact between the treatment head and the patient during the treatment is of essential importance for the effectiveness of the treatment. Therefore, if the contact is sufficient or not is displayed in the right section of the Phyaction 190, so that you are continually aware of the quality of the treatment. To prevent that you have to look to the appliance to see whether there is sufficient contact, you have the possibility to have an acoustic signal being produced in case of insufficient contact. In that case you will hear a short acoustic signal once every second. With the relating blue key you can switch the acoustic signal on and off. In the right upper corner of the screen you can see whether the signal is on or off. If, despite using contact gel, there is insufficient contact with the patient the ultrasound power is automatically turned down. Overheating of the treatment head and subsequent wear of the head is thus limited. Furthermore, the yellow lamp beside the output connector of the treatment head goes out in order to show that power is no longer being emitted. Additionally, the timer stops when there is insufficient contact so that the set time is actually utilized. After contact has been re-established, for example by the application of more gel or by improving contact between the treatment head and the patient, the timer re-starts and the originally

4. INTRODUCTION COURSE

Instructions for use Phyaction 190 - Page 8

set intensity is emitted through the appliance. For more detailed information concerning contact control please refer to section 8.6. 4.11 Treatment memory This is dealt with in detail in chapter 6 PROGRAMMABLE MEMORY. 4.12 Selecting a therapeutic application per indication This is dealt with in detail in chapter 9 THERAPEUTIC APPLICATIONS. 4.13 Altering the contrast The display contrast can be adjusted by pressing the blue button on the far right, after which the contrast symbol starts to flash. Using the black buttons you can then set the required contrast. 4.14 Starting from stand-by If you do not use the appliance for more than 5 minutes it automatically returns to stand-by and the green lamp continues to illuminate. For the first 5 minutes in the stand-by mode the screen is still illuminated and then the display becomes dark. By pressing any button the appliance is again ready for use. 4.15 Switching off When the equipment has not been used for more than 10 minutes it automatically switches to the stand-by position. The green lamp normally remains illuminated. If required, you can switch off the appliance completely using the mains switch on the back, near the bottom of the appliance. All programs in the treatment memory remain stored by the in-built permanent memory. The electrical self-test is only performed when the equipment is switched on using the main switch.

4. INTRODUCTION COURSE

Instructions for use Phyaction 190 - Page 9

CHAPTER 5

SYSTEM SETTINGS

5.1 Introduction You can set a wide range of parameters. To make it easier for you, Uniphy have already pre-programmed the most common values. In this manual we refer to them as the UNIPHY PRESETS. Each time that you switch on the equipment and select a therapy form, these presets appear on the display. When, however, you find that the Uniphy presets are not suitable, you can change them. If you change the parameters, your Phyaction remembers them until you select another program or until the equipment switches to the stand-by mode or is switched off using the main switch. After that the equipment will give the Uniphy presets when the program is started again. However, you can also program you own preferred settings into the memory, so that when the equipment is switched on your own presets are always used. We call your own settings the USER PRESETS. The equipment can store more than just parameters for you: the language with which you want to work and your desires for operating comfort. You will find all of the above special equipment settings in the menu SYSTEM SETTINGS, which you can display by pressing the yellow button. When the yellow button is depressed for 3 seconds, a screen appears in which the software version number, the release date of the software and the treatment head parameters can be read. You exit the menu by depressing the yellow button once more. The menu will automatically disappear approximately 30 seconds after the last button was depressed.

System presets 5.2 Selecting the operating language In the Phyaction 190 you have the possibility to change the operating language by depressing the yellow button. By depressing the button NL...SP you have the choice from various languages. Once selected, the equipment will use the language you have chosen. 5.3 Presets user In order to input your own presets into the equipment you must first change the parameters and then enter the value which you want to make your preset. Then hold down the yellow button for a few seconds until the SYSTEM SETTINGS menu appears and press the preset user button . When you enter the SYSTEM SETTINGS menu this sign will lighten up if you programmed your setting. 5.4 Presets Uniphy Using this you can reset the preset(s) which have been programmed by Uniphy. Press the yellow button till the SYSTEM SETTINGS menu appears, then press the blue button associated with the Uniphy preset . 5.5 Volume When you press the blue Volume button you can use the black buttons to set the strength of the sound signal on a scale of 1 to 3, where 3 gives the loudest bleep. 5.6 Sound signal setting A cross behind the loudspeaker symbol

5. STANDARD SETTINGS

will indicate that the signal is switched off.

Instructions for use Phyaction 190 - Page 10

CHAPTER 6

PROGRAMMABLE MEMORY

6.1 Introduction Your Phyaction has an electronic memory with 20 memory positions which gives you the option of saving data for later use. Using this you can, for example, create a "library" of special treatments with which you have achieved good results or of parameter settings which you use regularly. You can also reserve particular memory space for each patient or operator. Transferring treatment data to an observer is made easier by this. You can best imagine the memory as a card index which contains patients cards. Each patients card has a number and can contain data of the therapy form for this patient. If you want to store or look up something, naturally you must first ensure that you look up the correct patient card (No.). The operating principle of the memory is especially easy. We recommend that you try out the possibilities yourself. The symbols used are explained in chapter 15 EXPLANATION OF SYMBOLS. 6.2 Operating principle If you press the green (memory) button when you are in the therapy screen, five memory positions appear on an overview screen together with a brief report on the contents for each memory position. If the memory position is empty you will only see a dash behind the patient card number.

The memory overview screen In the top left corner of this screen there is the symbol of a card file. Using the black buttons or you can scroll between the four overview screens. The overview screens offer you clear information about the contents of the memory. By pressing the green button once more when in the overview screen, the first empty patient card appears. However, you can also select a patient card using the relevant blue button: after pressing the button the memory screen appears which contains a flashing figure. This is the Number of the selected patient card.

Patient card no. 3 The centre of the screen shows what you have saved on this card. If the card has not been used then the centre of the screen is empty. You have the following options: - using the black buttons and you can select another patient card; - using the blue button you can decide if you want to start, save or delete a treatment; - you can exit the memory via the yellow button, or by not touching a button for 2 minutes. 6.3 Saving data To save the data of a treatment you must first ensure that the relevant data is visible on the display. Therefore, set all required parameters for the relevant treatment first. The intensity to be saved can also be set when doing this. If you then press the green button, the memory overview screen appears. In this screen there are five patient card numbers which show the set parameters. When a patient card is empty a dash appears behind the relevant number. Using the black buttons and you can scroll between the four overview 6. PROGRAMMABLE MEMORY

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screens. To save data under a specific number, select the relevant patient card number using the blue button. If you want to retrieve the first empty patient card from the memory overview screen immediately and quickly, press the green button once again when in this screen. After selection of a patient card, a screen appears which shows the data which is saved at that moment on the patient card. When a patient card has not been used, the central screen is empty. Using the black buttons you can select another memory number (the memory number is already flashing; you do not have to select this parameter using the blue button). When a memory position is already occupied, the function Save does not appear beside the relevant blue button. However, in order to save data under this memory location you should firstly delete the programmed treatment data. See section 6.5. For an empty memory position the blue button Save ( ) appears. When you press this button the therapy data are saved and are displayed in the middle of the screen. On your card with the data of the relevant patient you then only need to state the selected number. You can exit the memory by using the yellow button. 6.4 Retrieving data By pressing the green button when you are in the therapy screen you will arrive in the memory overview screen. In this screen there are five patient card numbers showing the set parameters. When a patient card is empty, a dash appears behind the relevant number. Using the black buttons and you can scroll between the four overview screens. If you want to start a treatment from the memory position, select the required patient card first using the relevant blue button. When a treatment is programmed in a memory position, the treatment parameters appear in the middle of the memory screen. This treatment becomes active as soon as you press the blue Start ( ) button. After that you only need to turn up the intensity in order to start the treatment. If there is no treatment saved in a memory position, the middle of the screen is empty. In that case, the function Start does not appear beside the relevant blue button, therefore, no treatment can be started. As stated in the previous section about saving data, you can also save the set intensity. When retrieving the treatment parameters you will see, after you have pressed the blue Start button, the intensity value flashing in order to indicate what you had set during the last relevant treatment. When you turn the intensity knob the intensity values disappear and you can set the required value. 6.5 Deleting data If you want to delete a treatment you must access the memory using the green button. The memory overview menu appears. Using the black buttons and you can scroll between the four overview screens and select, using the blue button, the patient card from which you want to delete the data. Then press the function button Delete, symbolized by a torn patient card. You are then asked again if you really want to delete. If after further consideration you decide you do not want to delete, you can return to the memory location which you already had on the screen by pressing the blue button Do not delete ( ). If you decide you do want to delete data, press the blue button Delete once again. The memory card then becomes empty.

Deleting data By pressing Save you can, if required, save the set treatment which is shown in the treatment screen at that moment.

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CHAPTER 7

BASIC ULTRASOUND THERAPY INFORMATION

7.1 Definition of ultrasound therapy One understands for ultrasound therapy the medical treatment of patients by means of mechanical vibrations with a frequency of more than 20 kHz. For physiotherapy frequencies of between 0.8 and 3 MHz are used. 7.2 Generating vibration and tuning the treatment heads Fitted in Phyaction is a generator which generates a high-frequency electrical vibration. The piezoelectric crystal located in the treatment head is connected to this generator. The frequency of the generator must match the thickness of the crystal, which means that the treatment head and the equipment must be tuned to each other. The vibration plate produces vibrations. The intensity of the strongest vibration must be as low as possible since these can affect the operator via the side wall of the treatment head. Due to the special construction of the Phyaction treatment head this "side wall radiation" is negligible for the Phyaction 190. Furthermore, the danger of side wall radiation is further reduced because the therapist holds the treatment head in the "grip". 7.3 Continuous and pulsed ultrasound Your Phyaction can supply both continuous and pulsed ultrasound. Depending on the set intensity, the treatment time and the absorption coefficient of the tissue, one of the effects of continuous ultrasound can be the development of heat. Pulsing of the ultrasound beam reduces the heat development. Furthermore, this method can achieve a high intensity, which can result in damaging effects with continuous application. This high intensity can be responsible for the a-thermic effects which occur with pulsing ultrasound therapy. The effects of both continuous and pulsing ultrasound therapy are described in detail in section 7.9. 7.4 Properties of the ultrasound beam The ultrasound beam can be divided into two areas: the near field and the distant field. The near field is characterized by a light convergence of the ultrasound beam and by strength variations of intensity through interference effects in the ultrasound beam. The distant field is characterized by a divergence of the ultrasound beam, a gradual decrease in intensity and the almost lack of interference effects. The length of the near field is dependent on the diameter of the treatment head and on the frequency. For the treatment head with an ERA of 4 cm2, the near field is approximately 10 cm long, while the near field of the 1 cm2 is approximately 2 cm long (with 1 MHz). In general, it can be further specified that the length of the near field is reversed proportionally with the increase in frequency. Therapeutic effects are mainly reproduced in the near field. Because the ultrasound beam in the near field shows interference effects, a non-uniform sound beam results in which the intensity peaks can be many times higher than the set value. The beam non-uniformity ratio (BNR) indicates how many times the intensity peaks surpass the set value. For a good treatment head the BNR must be lower than 6, for the Uniphy treatment heads a BNR of 5 or less applies. In order to distribute the ultrasound energy as uniformly as possible the treatment head should always be moved during the treatment. Rotation of the treatment head in one location can result in intensity peaks at the same place, whereby an overdose can occur. We advise you against this. Because the peak piezoelectric crystal is smaller than the surface, the effective radiating area (ERA) of the treatment head is always smaller than the surface of the treatment head. In determining the intensity this must be taken into account, because the power/cm2 is set with regard to this and because the effective intensity of the ERA is dependent on this. In order to avoid confusion Uniphy have named the ultrasound heads according to the size of the ERA. Therefore, ultrasound heads with an ERA of 1 and 4 cm2 can be supplied. 7.5 Distribution and interference of ultrasound in the body As mentioned in the previous section, interference effects occur in the near field of the ultrasound beam, whereby increased intensity occurs proportional with BNR value. Additionally, interference effects can result through reflection. As a result of these interference effects two wave motions can strengthen or weaken each other. Strengthening can lead to an increase in intensity of the sound beam (mainly when the tissue layer is thin in the area of bone tissue, and consequently absorbs little ultrasound energy). Mainly with the application of continuous ultrasound this phenomenon can lead to periostial stimulation in the form of pain. By moving the ultrasound treatment head the chance of such periostial stimulation is reduced. By applying the underwater

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treatment method it can be avoided that the near field enters the body, whereby the interference effects in the body can be avoided. See section 8.3. Through divergence in the distant field and principally through reflection distribution of ultrasound occurs in the body. 7.6 Refraction and reflection of ultrasound With the transition from one tissue to another, depending on the angle of approach, the direction in which the ultrasound wave travels can change. This "refraction" is caused by differences in transition rate in the adjacent media. To achieve optimum treatment and to avoid refraction the ultrasound treatment head should be placed as perpendicular to the skin as possible. Reflection of the ultrasound occurs with the transition from one tissue to another. The intensity of the reflected energy depends on the differing mass density and transition rate of the adjacent media. The specific acoustic impedance of the medium is determined by the mass density of the medium multiplied by the transition rate of the medium. The closer the specific acoustic impedances of adjacent tissues lie to each other, the smaller the amount of reflection. Reflection of any significance only occurs in the body at the transition from soft parts to bone and is approximately 35%. Metal and air in the ultrasound beam can also cause reflection. The energy loss through reflection at the transition between the treatment head to the skin has already been calculated in by Uniphy. The value shown on the display is therefore the actual intensity which penetrates the body. 7.7 Contact gel Air extinguishes the ultrasound beam almost completely so it is necessary to use a good conductive substance between the treatment head and the body in order to effect an optimum transfer of ultrasound energy. In principle water is an excellent and cheap contact substance. The disadvantage, however, is that water has a low viscosity. Due to this slight viscosity, water is only suitable for the application of ultrasound therapy using the under water method which is described in section 8.3. In practice, contact gel based contact substances are used, which have as an advantage the fact that they never or hardly ever flow away. The specific acoustic impedance of the gel is approximately the same as that of the skin so that there is almost no reflection between these two media. Uniphy contact gel is supplied with your Phyaction. This skin friendly gel has such a viscosity that the gel does not flow too much during treatment. Additionally this gel possess very good transmission properties, causes little absorption loss, contains hardly any air bubbles, is not absorbed too quickly into the skin and is practically odourless. Besides this, the Uniphy contact gel possess excellent electrical contact properties. We therefore also advise you to use the Uniphy gel for ultrasound treatments. 7.8 Absorption coefficient, half value depth and penetration depth Energy must be absorbed before its application can have effect. For ultrasound therapy this means that we can only expect therapeutic effects as soon as ultrasound energy is absorbed. Biological tissues absorb ultrasound at different rates. The measure for absorption is the absorption coefficient. Tissues with a high protein level and a low water level appear to possess a high absorption coefficient. Absorption is also dependent on the ultrasound frequency: for lower frequencies the absorption in the tissues is lower than with high frequencies. A high absorption coefficient means a low penetration depth and vice versa. This relationship is linear between 1 and 10 MHz for all tissues with exception of bone tissue. One can conclude from this that for ultrasound with a frequency of 3 MHz the absorption coefficient is higher by a factor of 3 than with ultrasound with a frequency of 1 MHz. This has the result that ultrasound with a frequency of 1 MHz penetrates approximately three times deeper than ultrasound with a frequency of 3 MHz. Your Phyaction is delivered with treatment heads which can supply both 1 and 3 MHz, frequency change-over is via the equipment. This means that with one treatment head both surface as well as deeper lying complaints can be treated!

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Medium

Absorption coefficient per cm 1 MHz 3 MHz

Water Air

0.0006 2.76

0.0018 8.28

Blood Fat tissue Nerve tissue Muscle, longitudinal Muscle, cross direction Blood-vessel Skin tissue Tendon Cartilage Bone

0.03 0.14 0.20 0.76 0.28 0.40 0.62 1.12 1.16 3.22

0.09 0.42 0.60 2.28 0.84 1.20 1.86 3.36 3.48 unknown

↓ increasing protein level ↓ decreasing water level

Table 1. The absorption coefficient per cm of various media at 1 and 3 MHz The half value depth tissue property gives the distance in the direction of the sound beam in which the intensity decreases by half in particular uniform tissue. The half value depth is determined by the absorption coefficient. Table 2 shows the half value depths of various media at 1 and 3 MHz and from this figure it appears that 1 MHz of ultrasound penetrates deeper by a factor of approximately three than with 3 MHz of ultrasound. Additionally, it appears that for muscle tissue the direction of the ultrasound beam with respect to the muscle tissue has a large influence on the penetration of the ultrasound. In protein rich tissues, such as tendons and cartilage tissue a lot of ultrasound energy is absorbed, which means that similar tissues are best warmed up. This can give an explanation for the favourable therapeutic results with the treatment of these types of tissues.

Medium Fat tissue Muscle, longitudinal Muscle, cross direction Skin Tendon Cartilage Bone

half value depth in mm 1 MHz 3 MHz 50.0 9.0 24.6 11.1 6.2 6.0 2.1

16.5 3.0 8.0 4.0 2.0 2.0 ----

Table 2. The half value depth in mm of various media at 1 and 3 MHz The depth at which one can still expect a therapeutic effect is called the penetration depth: this is the point at which 10% of the administered ultrasound intensity remains.

Medium

penetration depth mm 1 MHz 3 MHz

Fat tissue Muscle, longitudinal Muscle, cross direction Skin Tendon Cartilage Bone

165 30 82 37 21 20 7

55 10 27 12 7 7 ----

Table 3. The penetration depth in mm of various media at 1 and 3 MHz

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7.9 Effects of ultrasound therapy Using ultrasound both "indirect" (at distance) and "direct" localized treatments can be given. For indirect treatment it is attempted to obtain an effect from a distance using ultrasound. The affected tissue is treated directly, mostly para-vertebral, whereby sympathetic damping is described as an effect. Other localities within the same segment are also eligible for segmental treatment. For direct treatment the affected tissue is locally treated. Ultrasound is mostly used in this way, although a combination of local and segmental application is also described in the literature. The following effects of ultrasound are described: Micromassage: as a result of the ultrasound vibrations the tissues begin to vibrate. This mechanical effect is also called "micromassage". All effects which occur through continuous or pulsing ultrasound are as a result of micromassage. Depending on the intensity of the energy with which treatment is undertaken, these effects can exercise either a favourable or unfavourable influence on the tissues. Heat generation: as a result of micromassage a very high rate area exists with an over and under pressure, which causes a to-and-fro movement of cell particles and cell elements. This causes friction and that friction leads to the development of heat. The amount of heat generated differs for various tissues. Heat seems to be generated particularly in tissues with a high absorption coefficient such as bone, cartilage, tendons, ligaments, blisters and periost In addition to the absorption coefficient of the tissue, the ultrasound forms (continuous or pulsating), intensity and treatment time play an important role with regard to this. Due to reflection, interference effects can occur which result in an increase in intensity. Bone tissue mainly reflects a large proportion of ultrasound waves (approximately 35%). An increase in intensity as a result of reflection can lead to heat development which causes periostial pain. By allowing the ultrasound to pulse the thermal effect is reduced. One can try to prevent an uneven intensity distribution by moving the treatment head. Absorption of ultrasound occurs especially in deeper tissues. Because special thermal sensors are only found in the skin, temperature increase in these deeper tissues can not be detected. However, if the temperature rises to 45°C one will have a sensation of pain. This pain sensation can be used as a limit for temperature increase. A short sensation of pain up to 45°C is not dangerous (according to the literature). When the patient experiences persistent or increasing pain, the intensity must be reduced or switched over to pulsating ultrasound. For complaints where inflammation (warmth, redness, swelling, pain and loss of function) are present an increase in temperature can work to a disadvantage. Such complaints are thus contra-indicated and continuous ultrasound should not be applied to the tissue. Since pulsating ultrasound can also cause an increase in temperature, we advise you to wait a day or two before starting an ultrasound treatment for acute injuries such as an ankle sprain. For joint inflammation for rheumatoid and arthritic complaints you are warned about the consequences of an intra-articular temperature increase. See chapter 10 INDICATIONS AND CONTRA-INDICATIONS. Temperature as a result of micromassage can result in a number of physiological effects: 1. Promoting blood circulation and improvement in metabolism. With a certain temperature increase the tissue reacts with vaso-dilation. This effect can occur with both continuous and pulsating ultrasound, although at a lower rate with pulsating ultrasound. 2. Improving the blood circulation and decline of the ortho-sympathetic activities can lead to muscle relaxation. 3. Reduction in pain. 4. Absorption of ultrasound can lead to an increase in the elasticity of connective tissue. 5. Promoting the regeneration power of the tissues. There are a number of non-therapeutic effects of ultrasound therapy which by definition have negative effects, such as: 1. Tissue damage. High intensity ultrasound therapy causes a strong mechanical peak load on the tissue. This can lead to mechanical and/or thermal tissue damage. It is therefore sensible to set the intensity in such a way that the patient can not experience a persistent or increasingly painful stimulation. Worth mentioning is that the output of your Phyaction is such that this effect does not or will only rarely occur. By the application of pulsating ultrasound these effects can be pushed to the background. 2. Stationary blood cells. Continuous movement of the treatment head is sufficient to eliminate this effect. 3. Other effects: a number of other effects can occur due to an overdose: decrease in blood sugar level, fatigue, nervousness, irritability, variable appetite, constipation and tendency to catch cold.

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