OPERATING INSTRUCTIONS PSORIAMED Revision: 1.0-D 01501 GB
Legal Notice Distribution, reproduction and translation of the software and its documentation (or excerpts thereof) are prohibited without the prior written consent of PHYSIOMED ELEKTROMEDIZIN AG. PHYSIOMED ELEKTROMEDIZIN AG reserves the right to change the software and associated data as well as the documentation without notice. All other rights reserved. PHYSIOMED ELEKTROMEDIZIN AG Hutweide 10 D-91220 Schnaittach/Laipersdorf (Germany) Phone: +49 9126 2587-0 Fax: +49 9126 2587-25 E-Mail: info@physiomed.de Internet: http://www.physiomed.de PSORIAMED is made in Germany in compliance with the quality requirements of DIN ISO 13485:2003, DIN ISO 9001 and the applicable safety standards and regulations of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. The compliance with the regulations mentioned here is indicated by the CE label on the instrument. The declaration of conformity might be requested from the manufacturer at the address given above. A conformity check acc. to Annex II, approved by the notified body 1275, was carried out.
PHYSIOMED ELEKTROMEDIZIN AG Table of Contents Table of Contents Chapter 1 Introduction................................. 1 1.1 Conventions Used................................. 1 1.2 Instrument Symbols................................ 1 1.3 General Notes................................... 1 1.4 Instrument Description.............................. 2 1.5 Instrument Overview............................... 3 1.6 Application.................................... 3 1.7 Contraindications................................. 4 Chapter 2 Indicators and controls........................... 5 2.1 Display <1>.................................... 5 2.1.1 Symbols in the Display <1>............................ 5 2.2 Data Selector <2>................................. 6 2.3 Intensity Control.................................. 6 2.3.1 Automatic Output Current Switch-off....................... 6 2.4 Patient Current Indicator <5>........................... 7 2.5 Output Indicator <6>............................... 7 2.6 Mains Module <7>................................ 7 2.7 Power Switch <8>................................. 8 2.8 Patient Socket <9>................................ 8 2.8.1 Patient Cable................................... 8 2.9 Footswitch Socket <11>.............................. 8 2.9.1 Footswitch..................................... 9 Chapter 3 Overview of Current Mode IFS...................... 10 3.1 Settings for IFS.................................. 10 3.2 Description of Current Mode IFS........................ 10 Chapter 4 Operating the Instrument......................... 11 4.1 Mains or Battery Operation........................... 11 4.1.1 Notes for Handling the Batteries........................ 12 4.1.2 Economy Mode................................. 12 4.2 Starting up the Instrument........................... 12 PSORIAMED i
Table of Contents PHYSIOMED ELEKTROMEDIZIN AG 4.3 Function Check................................. 13 4.4 Instrument Error................................. 13 Chapter 5 Stimulation Current Therapy....................... 14 5.1 Safety Precautions for Electrode Attachment.................. 14 5.2 Safety Precautions for Intensity......................... 14 5.2.1 Recommended Intensities............................ 15 5.3 Preparation and Attaching the Electrodes.................... 15 Chapter 6 Indications Menu.............................. 17 Appendix A Annex..................................... 23 A.1 Customer Service, Maintenance, Service.................... 23 A.2 Cleaning and Disinfection............................ 23 A.3 Service Life and Disposal............................. 23 A.4 Electromagnetic Compatibility.......................... 24 A.5 Basic Settings.................................. 24 A.6 Technical Data.................................. 25 Appendix B Scope of Delivery and Accessories.................... 26 B.1 Scope of Delivery................................ 26 B.2 Available Accessories.............................. 26 Appendix C Supplementary Documents........................ 28 C.1 Manufacturer s Recommendations....................... 28 Index...................................... 29 ii PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction Chapter 1 Introduction With PSORIAMED, you have acquired a high-quality and extremely versatile unit for stimulation current therapy. The instrument will only show its true potential, however, if you are well informed about its functions. For this reason, carefully read the operating instructions and familiarise yourself with the use of the instrument. 1.1 Conventions Used Please note the following typographical conventions in these Operating Instructions: Cross references and important terms used for the first time in this document are written in italics. Names of menus and symbols on the display are written in bold typeface. Paragraphs that deserve special attention are highlighted in the following way: Symbol Type Meaning Tip Note Important Caution Intended to give you some extra hints for more convenient operation Provides background information for better understanding Prevents misunderstandings that might lead to limited operation of the instrument or insufficient therapeutical results Alerts you in cases of possible damage to the instrument or risks of injury 1.2 Instrument Symbols The meanings of the symbols placed on the instrument are as follows: Symbol Meaning CAUTION! Refer to the Operating Instructions and consider the physiological effects of the parameters! Application part Type BF, not connected to the protective conductor Ensure environment-friendly disposal! Instruments that have reached the end of their life cycle (see Service Life and Disposal on page 23) must by any means be disposed of separately from household garbage! 1.3 General Notes PSORIAMED meets the technical requirement VDE 0750/IEC 601-1 and is assigned to class IIa according to the directive concerning medical devices. PSORIAMED 1
1 Introduction PHYSIOMED ELEKTROMEDIZIN AG The instrument may only be operated by personnel who have undergone special training! The instrument is to be operated properly, i.e. in accordance with the operating instructions. It is not intended for operation in explosion hazard zones or hydrotherapy rooms. Drastic temperature changes should be avoided, since condensation could be caused within the instrument. Do not start up the instrument until it is in temperature equilibrium with its environment! Operating the instrument in the vicinity (e.g. 1 m) of a short-wave or micro-wave therapy unit may cause output irregularities and should for this reason unconditionally be avoided as well as simultaneously treating the patient with a high frequency surgery unit. Operating the electrodes near the thorax may increase the risk of ventricular fibrillation. Make sure that the therapy circuit is not disconnected or connected incorrectly! In particular, movable electrodes may neither be removed from the treatment shells nor dipped during current conduction! Appliances inserted in the treatment shells serving to position the patient (e.g. arm rests) have to be installed ensuring they do not affect the current conduction! Conductive parts inserted in the treatment shells lead to a risk of a chemically burn of the skin and technical malfunctions! Patients with an implanted electronic instrument (e.g. a pacemaker) must not be treated with stimulation current! Patients with a metal implant (e.g. a nail) are not to be treated with stimulation current without previously consulting a doctor! During the treatment, neither water supply to the treatment shells nor water drain from them is to be performed! During treatment with stimulation current, only isolated (ungrounded) devices or parts of devices are allowed to be located within the patient environment! Caution Treatment is only to be performed in battery operation! No mains plug or protective conductor may be connected! Do not use any external switch (e.g. multiple socket outlets) to disconnect the instrument from the mains supply! 1.4 Instrument Description PSORIAMED is a mobile one channel stimulation current therapy unit. It features special mid-frequency current types for psoriasis treatment. The instrument has a battery and can therefore be used outside the house. It can only be used if it is not connected to the mains supply. The functions of PSORIAMED are microprocessor controlled. The processor constantly controls vital components and prevents malfunctions. After switch-on, all functions are checked in a self test. The instrument complies with all security standards currently valid. It meets all requirements of the EC directive concerning medical devices (93/42/EEC) and is therefore CE-labelled. 2 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction 1.5 Instrument Overview Legend 1 Display 7 Mains Module 2 Data Selector 8 Power Switch 3 Intensity Control 9 Patient Socket 5 Patient Current Indicator 11 Footswitch Socket 6 Output Indicator 1.6 Application PSORIAMED serves for conservative therapy that is free of side-effects, in the senso of a complete remission or significant improvement of the psoriasis disease pattern. Important The instrument may only be operated by personnel who have undergone special training! The instrument is to be operated properly, i.e. in accordance with the operating instructions. PSORIAMED 3
1 Introduction PHYSIOMED ELEKTROMEDIZIN AG 1.7 Contraindications Treatment is not to be performed in case of: Highly inflammable, aguish diseases Pregnancy Patients with pacemakers or other implanted stimulators Malign tumours 4 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 2 Indicators and controls Chapter 2 Indicators and controls PSORIAMED is constructed for easy operation. The instrument can be easily transported due to its small size. Treatment is performed in battery operation with the instrument not connected to the mains supply (refer to Mains or Battery Operation on page 11). All indicators and controls are integrated in the casing, making it easy to clean the surface and protecting the instrument from dust. The microprocessor of the instrument controls the safety-relevant components, prevents malfunctions and checks the instrument after every switch-on. 2.1 Display <1> In Display <1>, all menu items and therapy parameters of the instrument excluding the intensity are selected on different levels. Selection is performed by means of the Data Selector <2>. 2.1.1 Symbols in the Display <1> The following symbols can be found in Display <1>: Symbols in Lower Status Bar Battery charge state (refer to Mains or Battery Operation on page 11) Quit menu and return to start monitor PSORIAMED 5
2 Indicators and controls PHYSIOMED ELEKTROMEDIZIN AG 2.2 Data Selector <2> The Data Selector <2> serves to select the treatment parameters and to operate the instrument with the cursor. By turning the selector to the right or to the left, you can move the cursor to other menu items. You get to the respective menu by pressing the selector. To select parameters, move the cursor by turning the selector to the respective field. After pressing the selector, the cursor starts flashing. You can select the parameters or the menu turning the selector and confirming the selected value pressing the selector again (cursor stops flashing). The parameter set is displayed in the upper status bar or at a respective position in Display <1>. 2.3 Intensity Control The Intensity Control <3> serves to adjust the current (intensity) in steps of 1 ma. When enhancing the intensity, the therapy timer in Display <1> is started. Alternatively, you also can set the intensity via foot switch (refer to Footswitch on page 9). For treatment of hands and elbows, this is the recommended setting. Note For reasons of safety, the intensity is limited by the instrument depending on the treatment program to avoid an overdose! Convenient Reduction of Intensity The intensity can also be reduced to 0.0 ma automatically: Keep Intensity Control <3> depressed until a short acoustic signal sounds. Afterwards, the instrument automatically reduces the intensity to zero. 2.3.1 Automatic Output Current Switch-off PSORIAMED has an automatic output current switch-off that deactivates the instrument when the current flow of the electrodes is interrupted (electrode falls of, plug disconnects from patient cable, hand or foot is removed from the treatment shell, etc.). The message CHECK ELECTRODES I is displayed in the lower status bar and the current is reduced automatically. The timer stops the therapy time. As soon as the error is corrected, you have to turn the Intensity Control <3> to the left by one position. The message disappears and you can turn up the intensity again. 6 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 2 Indicators and controls 2.4 Patient Current Indicator <5> Flashing of the indicator depends on the resistance attached. The point in time when the indicator flashes is in most cases identical with the time the patient first senses the current clearly. Important If the indicator does not flash during treatment, a functional test has to be performed checking the flashing. If the indicator still does not flash during treatment after the test, the accessories have to be checked and replaced if necessary, too! 2.5 Output Indicator <6> The Output Indicator <6> reminds you to be careful using the electrodes. Caution If Output indicator <6> flashes, current is applied to Patient socket <9>! Make sure you do not touch the electrodes when the current is turned up! 2.6 Mains Module <7> The Mains Module <7> to attach the mains cable is located on the rear face of the instrument. Important For mains supply only use the mains cable provided by the manufacturer! No therapy can be performed when PSORIAMED is connected to the mains supply! PSORIAMED 7
2 Indicators and controls PHYSIOMED ELEKTROMEDIZIN AG 2.7 Power Switch <8> The Power Switch <8> is located on the left side of the instrument (if looked at from the front). You can switch the instrument on and off by means of this switch. After it is switched on, the instrument performs an automatic self test (refer to Function Check on page 13). 2.8 Patient Socket <9> The Patient Socket <9> on the rear face of the instrument serves to connect the patient cable. Plate electrodes or other types of electrodes can be connected to the patient cable. 2.8.1 Patient Cable One end of the patient cable is connected to the patient socket, the other end to the connection cables of the respective electrodes. Patient cable 2.9 Footswitch Socket <11> The Footswitch Socket <11> on the rear face of the instrument serves to attach the footswitch with which you can set the current (intensity) and interrupt the therapy. 8 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 2 Indicators and controls 2.9.1 Footswitch The intensity can be increased and reduced with the footswitch. A running therapy can be stopped. Footswitch (order. no. 00719) The individual buttons of the footswitch have the following functions (cable on the left side): Right buttons: Stop buttons (interrupt therapy) Left buttons: Increase intensity (at the top), reduce intensity (at the bottom), with repeat function After pressing the stop button, the intensity is automatically reduced to zero and the timer stops. The treatment can be continued by increasing the intensity with the intensity control of the footswitch. Repeat Function The buttons on the left side serving to reduce or increase the intensity have a repeat function. If you keep the respective key depressed for a certain time, the intensity is increased or respectively reduced continually! Emergency Switch-off The two buttons on the right side (stop) act as emergency switch-off buttons. By pressing one of the buttons, the treatment is immediately interrupted and the current is slowly reduced! The treatment has to be restarted afterwards. PSORIAMED 9
3 Overview of Current Mode IFS PHYSIOMED ELEKTROMEDIZIN AG Chapter 3 Overview of Current Mode IFS 3.1 Settings for IFS The following settings are valid for current mode IFS: Therapy time display in minutes and seconds The timer stops when the intensity is set back to zero. As soon as the therapy time elapses, an acoustic signal sounds and the intensity is slowly reduced. The timer automatically sets the therapy time of a treatment. Selected current (intensity): The field displays the intensity in ma (milliampere). The bar chart below displays the percentage of the intensity maximally adjustable. 3.2 Description of Current Mode IFS Definition Application Modulated interference current Psoriasis treatment Current type IFS: Sinusoidal waves Parameters for Current Mode IFS Pulse form Sinusoidal waves Basic frequency 4,000 Hz Modulation 10 / 100 Hz 10 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 4 Operating the Instrument Chapter 4 Operating the Instrument The operational steps not linked to therapy directly are described in the following paragraphs. 4.1 Mains or Battery Operation PSORIAMED has to operation modes: Mains operation: This mode is only intended to charge the batteries. In the mains operation mode, no treatment can be performed. If the mains cable is connected, the current output via the electrodes is automatically interrupted Battery operation: Treatments can only be performed in this state. As long as the instrument is connected to the mains supply, current output is impossible. How to Charge the Battery To charge the battery, proceed as follows: (1) With the instrument switched off, plug the supplied mains cable in the Mains Module <7> on the rear face of the instrument. Note If the instrument is charged when it is switched on, an acoustic signal sounds and the switch symbol in Display <1> flashes. Switch the instrument off by means of the Power switch <8>. (2) Connect the mains cable to the mains supply (100-240 VAC 50/60 Hz). The following message is displayed in Display <1>: Mains operation (3) The instrument batteries are charged. If the batteries are completely discharged, the charge time is approx. 12 hours. The charge function is displayed in the lower status bar: Instrument connected to mains supply; Battery is charged Instrument not connected to mains supply; Battery operation only Battery charged completely PSORIAMED 11
4 Operating the Instrument PHYSIOMED ELEKTROMEDIZIN AG Important In order to ensure a long battery life, the batteries must be charged completely when first charged. The first charging procedure should not be interrupted! 4.1.1 Notes for Handling the Batteries If the capacity drops considerably during operation, the three step note system is activated: (a) The charge state symbol flashes. (b) An acoustic signal sounds every second and the charge state symbol flashes. The intensity is reduced prematurely. (c) The instrument switches itself off to avoid a complete discharge of the battery. In this case, recharge the battery as described under How to Charge the Battery on page 11. Important If the unit is not used for a longer period of time, please fully charge the battery once a month. This will help to avoid exhaustive discharge. 4.1.2 Economy Mode To save electricity, the instrument automatically switches to economy mode in the start menu. The Display <1> is no longer illuminated. By turning the Data Selector <2>, the illumination is switched on again. Note If the instrument is switched on, but is not operated, it switched itself off automatically after a certain time. To reactivate it, switch off the Main Switch <8> and switch it on again. 4.2 Starting up the Instrument Before you can perform the first treatment with PSORIAMED, you have to start it up correctly. Note Before the first therapy, you have to charge the battery completely (refer to How to Charge the Battery on page 11). How to Start up the Instrument To start up the instrument, proceed as follows: (1) Make sure that the instrument is switched off and that the mains plug is unplugged. 12 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 4 Operating the Instrument (2) Plug the patient cable into the Patient Socket <9>. (3) Switch the instrument on with the Main Switch <8>. The instrument performs an automatic self test checking all functions and default values. An acoustic signal sounds. The instrument is ready for operation. You are now in the default menu. Caution Make sure you do not touch the electrodes when the current is turned up! 4.3 Function Check If you are not sure whether your PSORIAMED is working correctly, you can perform a self test. How to Perform a Self test To perform an automatic self test, proceed as follows: (1) Switch off the instrument with the Main switch <8> and switch it on again. The instrument performs an automatic self test checking all functions and default values. An acoustic signal sounds. The instrument is ready for operation. You are now in the default menu. 4.4 Instrument Error If a malfunction is detected in the self test or during operation, a message that the instrument is in error condition is displayed in Display <1>. A numeric error code is displayed, e.g. <ERROR 10> Refer to operation manual!. The error codes make it easier to isolate and correct errors. The operation of the instrument is interrupted and the stimulation current output is switched off. In case of a error message, perform a self test once or several times first (refer to Function Check on page 13) and observe if the error still occurs. Important Inform your service partner if the monitoring note does not disappear even after several self tests! Never perform a treatment when the proper function of the instrument is not assured! PSORIAMED 13
5 Stimulation Current Therapy PHYSIOMED ELEKTROMEDIZIN AG Chapter 5 Stimulation Current Therapy In this chapter, you get general information about stimulation current therapy and notes how to attach the electrodes. Furthermore, special features and operational steps of different types of treatments with PSORIAMED are described. PSORIAMED is intended for the following types of treatments: Treatment under water with treatment shells (refer to How to Perform a Treatment with Treatment Shells on page 17) Treatment with special electrodes (refer to How to Perform a Treatment with Special Electrodes on page 19) Treatment with plate electrodes (refer to How to Perform a Treatment with Plate Electrodes on page 21) Therapy parameters are accessed via the indications menu. Further notes about the treatment can be found under Indications Menu on page 17. Important Always switch on the instrument BEFORE you attach electrodes to the patient! Only switch off the instrument AFTER you have removed the electrodes from the patient! 5.1 Safety Precautions for Electrode Attachment Unconditionally adhere to the following safety precautions for electrode attachment: Never place the electrodes on areas of the skin that show bruises or abrasions! Insert the conductive surface of the plate electrodes into the sponge bags as completely as possible, making them disappear completely so that they can not get in contact with the skin any longer! Make sure that the electrodes are applied to the skin with the thick side of the sponge bags! Regularly check the electrodes and have defective parts repaired or replaced! Always place the electrodes making sure that no water can intrude the device. Also pay attention if you spill something by mistake! 5.2 Safety Precautions for Intensity Unconditionally adhere to the following safety notes when adjusting the intensity of the stimulation current applied: Always take into consideration that the patient may have a changed sensibility in the treatment area and therefore does not clearly perceive the current! Careful dosage is in particular important for blond and light-skinned patients and thin-skinned persons! Point out to your patients that they unconditionally have to attract attention to themselves when they sense something unpleasant or even burning under one of the electrodes! Always place the footswitch in a position where the patient can interrupt the therapy at any point in time! 14 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 5 Stimulation Current Therapy Increase the current carefully until the patient senses a light tingling. This sensation can possibly disappear during the treatment due to the good compatibility of the current type IFS. However, the intensity must not be increased! 5.2.1 Recommended Intensities The maximum intensity to be applied depends on the type and size of the electrodes. Please observe the maximum intensities as specified in section Safety Precautions for Intensity on page 14! Plate Electrodes Type Size of the Plate Electrode (Viscose Cover; in cm) Effective Area (cm2) Maximum Intensity for Currents with High Galvanic Component (ma) EF 10 4.0 x 3.0 (5.5 x 5.0) 10 1 EF 50 8.0 x 6.0 (11.0 x 9.0) 50 5 EF 100 12.0 x 9.0 (14.0 x 12.0) 100 10 EF 200 17.0 x 11.0 (20.0 x 15.0) 200 20 5.3 Preparation and Attaching the Electrodes To prepare the electrodes, proceed as follows: (1) Before fixing the electrodes, make sure that the intensity is set to zero. (2) Connect the patient cable to the Patient Socket <9>. (3) Plug the plate electrodes or connection cables for other types of electrodes into the sockets of the patient cable (refer to Patient Cable on page 8). Caution Make sure you do not touch the electrodes when the current is turned up! (4) Before attaching the electrodes, check if the patient's skin shows any scars or bruises. Avoid such areas in any case! (5) Choose the size of the electrodes depending on the treatment area according to the principle: Electrode surface as small as necessary but as big as possible. The bigger the electrode surface, the more comfortable the treatment is for the patient. (6) Put the plate electrodes in the well-moistened electrode bags and fix them on the patient. Use tap water to moisten the viscose bags. Make sure that the entire electrode surface fits well to the skin with the thick side of the electrode bag. Moisten the special electrodes with tap water or saline solution (1%). When treating in the head area, hair has to be wet! Caution It is not permissible to exceed an effective current density of 2 ma/cm²! For that reason you should always use electrodes of sufficient size and attach them most carefully. If you use electrodes of various different sizes during a treatment, the smaller of the two electrodes, the so-called "active electrode", is always decisive when measuring the intensity! PSORIAMED 15
5 Stimulation Current Therapy PHYSIOMED ELEKTROMEDIZIN AG Additional information about type, size and application of the electrodes can be found in the supplied therapy manual Introduction to Therapy with PSORIAMED (order no. 00635). Note Clean and disinfect the accessories in contact with the patient after each treatment. Viscose bags, spacer grids and special electrodes should be replaced after each patient! 16 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 6 Indications Menu Chapter 6 Indications Menu You can choose the desired therapy mode of PSORIAMED via the indications menu. The following therapy modes are provided: Treatment under water with treatment shells Treatment with special electrodes Treatment with plate electrodes Note Clean and disinfect the accessories in contact with the patient after each treatment. Viscose bags, spacer grids and special electrodes should be replaced after each patient! How to Perform a Treatment with Treatment Shells To perform a treatment under water with treatment shells, proceed as follows: (1) Make sure that the mains cable is not connected and switch the instrument on by means of the Main Switch <8>. The Display <1> now displays the indications menu: Indications Menu (2) Connect the patient cable to the Patient Socket <9>. Caution Always arrange the electrodes and the instrument in such a way that no water can intrude the device. Also pay attention if you spill water by mistake! (3) Fill the treatment shells with water up to the maximum level. (4) Put the plate electrodes EF400 into the two treatment shells and fix the cables on the designated holder. (5) Cover the plate electrodes with the spacer grid. Caution You have to use the spacer grid in each case! The skin of the patient may never touch the electrodes directly! PSORIAMED 17
6 Indications Menu PHYSIOMED ELEKTROMEDIZIN AG (6) Select the desired indication (e.g. Psoriasis Elbows, Mornings). The info menu with therapy information is displayed: Therapy information (7) To turn the page, click on the icon. A therapy-related image is displayed on the last page. Therapy information Note If the icon flashes, you can turn the pages by turning the Data selector <2>. (8) Click on the OK icon to start the therapy. The therapy menu is displayed: Therapy menu (9) Immerse the limbs into the treatment shells. (10) Carefully increase the intensity with the footswitch or the Intensity Control <3> slightly above threshold until you sense a slight tingling. 18 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 6 Indications Menu Note For reasons of safety, the intensity is limited by the instrument depending on the treatment program to avoid an overdose! Important If you are treating the upper limbs, it is recommended to adjust the intensity with the footswitch! Caution Never operate the instrument with wet hands! (11) An acoustic signal sounds when the time has elapsed. Remove the limbs from the treatment shells. How to Perform a Treatment with Special Electrodes To perform a treatment with the special electrodes for head or arm available as accessories, proceed as follows: (1) Make sure that the mains cable is not connected and switch the instrument on by means of the Main Switch <8>. The Display <1> now displays the indications menu: indications menu (2) Connect the patient cable to the Patient Socket <9>. (3) Fix the special electrode on the part of the patient's body to be treated (head or arm). Important Moisten the special electrodes with tap water or saline solution (1%). When treating in the head area, hair has to be wet! (4) Fix the connection cable at the contacts of the special electrode. To avoid a short-circuit, you must not fix both cables at the same contact, otherwise therapy will be ineffective. (5) Plug the connection cable for the special electrode into the patient cable sockets (refer to Patient Cable on page 8). (6) Select the desired indication (e.g. Psoriasis Arm, Mornings). The info menu with the therapy in- PSORIAMED 19
6 Indications Menu PHYSIOMED ELEKTROMEDIZIN AG formation is displayed: Therapy information (7) To turn the pages, click on the icon. A therapy-related image is displayed on the last page. Therapy information Note If the icon flashes, you can turn the pages by turning the Data Selector <2>. (8) Click on the OK icon to start the therapy. The therapy menu is displayed: Therapy menu (9) Carefully increase the intensity with the footswitch or the Intensity Control <3> slightly above threshold until you sense a slight tingling. Note For reasons of safety, the intensity is limited by the instrument depending on the treatment program to avoid an overdose! 20 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG 6 Indications Menu (10) An acoustic signal sound s when the therapy time elapses. The intensity is automatically reduced to zero. Remove the electrodes. How to Perform a Treatment with Plate Electrodes To perform a treatment with plate electrodes but without a water quench, proceed as follows: (1) Make sure that the mains cable is not connected and switch the instrument on by means of the Main Switch <8>. The Display <1> now displays the indications menu: indications menu (2) Connect the patient cable to the Patient Socket <9>. (3) Put the plate electrodes into the well-moistened electrode bags and fix them using elastic fabric tape on the patient's body part to be treated (e.g. on the torso). Use tap water or saline solution (1%) to moisten the viscose bags. Make sure that the entire electrode surface fits well to the skin with the thick side of the electrode bag. (4) Plug the connection cable for the plate electrodes into the patient cable sockets (refer to Patient Cable on page 8). (5) Select the desired indication (e.g. Psoriasis Torso, Mornings). The info menu with the therapy information is displayed: Therapy information (6) To turn the pages, click on the icon. A therapy-related image is displayed on the last page. PSORIAMED 21
6 Indications Menu PHYSIOMED ELEKTROMEDIZIN AG Therapy information Note If the icon flashes, you can turn the pages by turning the Data Selector <2>. (7) Click on the OK icon to start the therapy. The therapy menu is displayed: Therapy menu (8) Carefully increase the intensity with the footswitch or the Intensity Control <3> slightly above threshold until you sense a slight tingling. Note For reasons of safety, the intensity is limited by the instrument depending on the treatment program to avoid an overdose! (9) An acoustic signal sounds when the therapy time has elapsed. The intensity is automatically reduced to zero. Remove the electrodes. 22 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG Annex Appendix A Annex A.1 Customer Service, Maintenance, Service The manufacturer is responsible only for the original security relevant properties of the instrument. The instrument must be used generally in conformance with the user manual. Maintenance measures on the instrument may be carried out only at the PHYSIOMED ELEKTROMEDIZIN AG authorised locations. If the work is carried out by such locations, a certification should be obtained from them about the type and extent of the work. possibly with information relating to the modifications in the rated data or the work range. The certification must also contain the date of execution as well as company name and signature. Failed components, which influence the safety of the instrument, must be replaced with original parts. Circuit diagrams, parts lists and service instructions shall be made available to qualified technical personnel of the user on request. We recommend carrying out regular servicing of the instrument and accessories. The defined safety-relevant inspections are given in the manufacturer's recommendations (see Manufacturer s Recommendations on page 28). A.2 Cleaning and Disinfection Clean accessories and instrument on a regular basis with a disinfecting agent based on aldehyde. By any means, switch off the device prior to this and pull the mains plug. Use a soft sponge cloth for cleaning. Be careful that no liquid substances invade the instrument. Clean and disinfect the sponge and sponge bags after every treatment, and then rinse them well with fresh water, so that no residue remains on the material. Regularly check your accessories and replace any sponges and sponge bags which are contaminated, damaged or worn out through use, and which are no longer sufficiently thick. A.3 Service Life and Disposal Due to legislation, the service life of a medical product has a limit of ten years. When its service life has elapsed, the instrument has to be disposed in compliance with the legal obligations. Therefore, pay attention to the applicable regulations for environment protection. Please contribute to environment protection by not putting used instruments into your domestic waste. PSORIAMED 23
Annex PHYSIOMED ELEKTROMEDIZIN AG A.4 Electromagnetic Compatibility Declaration in accordance with standard EN 60601-1-2: Electromagnetic compatibility Medical electrical devices are subject to particular precautions regarding electromagnetic compatibility and must be used in accordance with the instructions on electromagnetic compatibility contained in the accompanying documents. Portable and mobile HF communication devices can affect medical electrical devices (see the supplement on electromagnetic compatibility, technical description). A.5 Basic Settings In the Basic Settings menu, you can adjust the following device parameters: Symbol Meaning Contrast of the Display <1> How to Change the Basic Settings (1) Switch the device on. (2) On the start screen, click on SETMENU. You get to the Basic Settings menu. Basic Settings (3) Click on the symbol for the parameter you want to change (e.g. for the contrast ). (4) Turn the Data Selector <2> until the parameter accepts the value desired. (5) Click on the symbol. You return to the start screen. The changed settings are immediately effective. 24 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG Annex A.6 Technical Data General Technical Data Protection class acc. to VDE 0750 / IEC 601-1 I (mode of operation: charging) CE characterization Class acc. to Council Directive concerning medical devices Mains supply Mains frequency Power consumption II (mode of operation: treatment) Typ: BF acc. to Council Directive concerning medical devices (93/42 EEC) IIa 100... 240 VAC 50... 60 Hz 25 VA Ambient temperature (operation) + 10 C... + 40 C Dimensions (W x H x D) Weight 31.5 x 10.4 x 33.5 cm 3.3 kg Output Data - Stimulation Current Mode Medium frequency current mode (IFS) Output Data 85 ma eff / 500 Ohm PSORIAMED 25
Scope of Delivery and Accessories PHYSIOMED ELEKTROMEDIZIN AG Appendix B Scope of Delivery and Accessories Important For safety reasons, the instrument is to be used exclusively with original accessories. The use of other manufacturers' accessories is at the user's risk! B.1 Scope of Delivery PSORIAMED is supplied with the following accessories: Ref. No. Designation Number 00776 Mains cable 1 00187 Patient lead (bipolar) 1 00497 Plate electrode EF400 / 24,5 x 15,5 cm (set of 2) 1 00425 Spacer grid (set of 10) 1 01102 Stimulation current instrument PSORIAMED 1 00575 Transportation bag 1 00421 Treatment shell 2 00453 Velcro strap 10 x 125 cm 2 00431 Viscose cover EF400 / 26 x 18 cm 2 01501 Operating Instructions (English) 1 00635 Introduction to Therapy with PSORIAMED (English) 1 B.2 Available Accessories For PSORIAMED, the following additional accessories are available: Ref. No. Designation 00500 Connection cable with clamp fastening (set of 2) 00719 Footswitch 00776 Mains cable 00187 Patient lead (bipolar) 00536 Plate electrode EF200 / 17,5 x 11 cm; individual: cable blue, connector blue 00537 Plate electrode EF200 / 17,5 x 11 cm; individual: cable red, connector red 00480 Plate electrode EF200 / 17,5 x 11 cm; set: 1 x 00536, 1 x 00537 00498 Plate electrode EF400 / 24,5 x 15,5 cm; individual: cable blue, connector blue 00499 Plate electrode EF400 / 24,5 x 15,5 cm; individual: cable red, connector red 26 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG Scope of Delivery and Accessories Ref. No. Designation 00497 Plate electrode EF400 / 24,5 x 15,5 cm (set of 2) 00422 Spacer grid (set of 2) 00418 Special electrode (arm) 00419 Special electrode (head) 00457 Special electrode (knee), medium 00456 Special electrode (knee), small 00575 Transportation bag 00421 Treatment shell 01003 Trolley Universal II 00451 Velcro strap 6 x 80 cm 00453 Velcro strap 10 x 125 cm 00439 Viscose cover EF200 / 20 x 14 cm 00431 Viscose cover EF400 / 26 x 18 cm PSORIAMED 27
Supplementary Documents PHYSIOMED ELEKTROMEDIZIN AG Appendix C Supplementary Documents C.1 Manufacturer s Recommendations 28 PSORIAMED
PHYSIOMED ELEKTROMEDIZIN AG Index Index A accessories available 26 ambient temperature 25 application 3 automatic switch-off output current 6 B basic settings 24 batteries handling 12 battery operation 11 C CE characterization 25 cleaning 23 compatibility electromagnetic 24 contraindications 4, 4 contrast 24 controls 5 convenient reduction of intensity 6 current consumption 25 current type IFS 10 customer service 23 D data selector 6 dimensions 25 disinfection 23 display 5 contrast 24 symbols 5 disposal 23 E economy mode 12 electrodes preparation 15 EMC 24 error codes 13 F footswitch 9 footswitch socket 8 function check 13 I IFS (current type) 10 indications 3, 17 indications menu 17 indicators 5 instrument description 2 instrument error 13 instrument overview 3 instrument symbols 1 intensities recommended 15 intensity control 6 Introduction 1 L line fuses 25 M mains connection 25 mains module 7 mains operation 11 mains supply 7 maintenance 23 manufacturer s recommendations 28 N notes general 1 O operation 11 output current automatic switch-off 6 output indicator 7 P patient cable 8 patient current display 7 patient socket 8 power data 25 power line frequency 25 power line input 25 power switch 8 preparation electrodes 15 protection class 25 S safety precautions electrode attachment 14 PSORIAMED 29
Index PHYSIOMED ELEKTROMEDIZIN AG intensity 14, 15 scope of delivery 26 service 23 service life 23 starting up 12 T technical data 25 therapy stimulation current 14 W weight 25 30 PSORIAMED