USER MANUAL
Contents
1. Following buttons are at the right of the patient list e Info The screens give all information on the selected patient The information Is shown in 3 screens General information on the patient List of saved treatment data VAS scores of the selected treatment in screen 2 are shown In a graphic This graphic shows the progression of the treatment gymna 33 r Load Load the selected patient A pop up with the VAS visual analog scale automatically opens to evaluate the therapy based on the pain of the patient Patient 3 09 7011 15 34 Load Hans Gravels Please enter current Vas score A VAS Is a pain measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured Operationally a VAS is usually a horizontal line LOOmm in length The patient marks on the line the point that they feel represents their perception of their current state After filling in the VAS score you automatically go to the treatment screen The name of the selected patient appears in the middle of the treatment screen After ending the treatment a pop up appears to save the data of the treatment These data will be available in the info look at the top of this section Edit A similar screen as new patient but all data are already filled in These data can be edited Delete Delete t2. USER MANUAL ShockMaster 500 C 0197 vis 2 gymna Copyright Uniphy Elektromedizin GmbH amp Co KG 2011 ShockMaster is a registered trademark of GymnaUniphy Unauthorised reproduction either in whole or part of the software provided with this product is strictly prohibited and is subject to prosecution All rights reserved ShockMaster 500 is manufactured in Germany by Uniphy Elektromedizin GmbH amp Co KG Neuendorfstra e 19 b D 16 61 Hennigsdorf Germany T 49 0 3302 5044 0 F 49 0 3302 5044 99 info uniphy elmed com info shockmaster eu www shockmaster eu gymna 3 General Information 1 1 Introduction 1 1 1 Indications 1 1 2 Lontra indications 1 1 3 Side effects LZ Prerequisites for operating the ShockMaster 500 1 2 1 Operator 1 2 2 Training of the operator Re Description of controls and functional elements 14 Description of used marks and symbols Installation FJ Unpacking 22 Scope of supply 2 2 1 Connecting the compressed air supply 2 2 2 Connecting the power supply cables 2 2 3 Hand piece connection Operation aA General warnings and safety information Je Operation 3 2 1 The user interface 3 2 1 1 Introduction 3 2 1 2 Treatment screen 3 2 1 2 1 Parameters 3 2 1 2 2 Graphic representation of an uploaded indication 3 2 1 3 Indications list 3 2 1 4 Body area 3 2 1 5 Patient database 3 2 1 6 Anatomical library screen 3 2 1 7 Settings screen 3 2 1 8 Software update 3 3 Start up
3. 44 gymna 4 5 Repair Repair work on defective equipment must only be carried out by personnel suitably authorized by GymnaUniphy Only original GymnaUniphy spare parts may be used for this purpose gymna 45 5 Status messages and trouble shooting 5 1 Status messages Control device failure Restart the system Call service if the problem persists 5 2 Trouble shooting CAUTION Unplug the mains cable from the system before you carry out any maintenance work 46 gymna System does not work Power failure Check the power supply Defective mains fuse Replace the fuses Defective mains cable Replace the mains cable No compressed air Supply Main switch of compressor off Switch on compressor connecting cable Check the cable and tube connec tions and replace them if necessary Leaks on hand piece cable or cable not properly connected Compressed air tube not con Check the compressor air filter and nected or not correctly fastened replace it if necessary with safety coupling Clogged compressor air filter No shockwave power output No compressed air Supply Check the compressed air Supply Blocked or worn projectile Take hand piece apart Malfunction in control system Clean the guide tube and projectile Overhaul the hand piece Call your Service center Replace the hand piece gymna 47 6 Accessories and spare parts 6 1 ShockMaster 500 Compressed air tube e Compressed air tube 1 m
4. gymna 9 The operator must be instructed in the following points e Instruction in operation and designated use of the device with practical exercises e Mode of effect and function of the device and the applied energies e Settings of all components e indications for use of the device e Contra indications and side effects of the therapy waves e Explanation of the warning notes in all operating statuses e Instruction in how to perform the functional checks Further training requirements vary from country to country It is the operator s responsibility to ensure that the training meets the requirements of all applicable local laws and regulations Other information about training in the operation of this system can be obtained from your GymnaUniphy dealer However you can also contact the following address directly GYMNA UNIPHY NV Pasweg DA 3740 Bilzen Belgie T3200 6S 510510 Foto 089510511 Info gymna uniphy com 10 gymna LCD TFT Touch Screen Connector R Sw V ACTOR hand piece channel black Connector R Sw V ACTOR hand piece channel yellow R SW hand piece AUW NE 1 Connector R SW V ACTOR hand piece channel black 2 Connector R SW V ACTOR hand piece channel yellow gymna 11 USB connector Type A Compressed air connector Auxiliary outlet line out for compressor Mains connector Mains fuse holder Mains switch Label 5A max Read the manual first ONAWBRWN 12 gymna 1 4 Description
5. 250VAC e Pull the old fuses out of the fuse holder Replace the fuses with the same type only Push the fuse holder back into the opening until it engages gymna 43 4 3 Maintenance Preventive maintenance is not necessarily required However regular maintenance may help to identity possible defects at an early stage and thus increase the safety and service life of the equipment Maintenance services can be ordered from our regional representatives in your area or directly from GymnaUniphy We recommend that functional and safety checks be performed at least once a year National accident prevention regulations and test and inspection intervals prescribed for medical devices must of course be observed Please pay attention to the separate maintenance Instructions for the compressor NOTE For further details on content and performance of the safety checks please contact your local dealer NOTE Make sure the equipment will checked one a year by an authorized service personnel according test protocol for medical electrical appliances 4 4 Disposal When disposing of the present medical products no special measures have to be observed Please proceed In accordance with the national regulations After expiration of its life time dispose the ShockMaster 500 as electronic scrap For additional information about the disposal of the Sil Air 50 TDC compressor please refer to the separate operating manual
6. According to IEC 60601 2 36 this doesn t comply during the generation and release of shockwaves RF emissions CISPR 11 The ShockMaster 500 is suitable for use in all Harmonic emissions IEC 61000 3 2 Class A establishments including domestic establish ments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Complies 52 gymna Guidance and manufacturer s declaration electromagnetic immunity The model ShockMaster 500 is intended to use in the electromagnetic environment specified below The customer or the user of the ShockMaster 500 should assure that It is used in such an environment IEC 60601 test level Compliance level Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient Bursts IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE 6kV contact BKV air 2kV for power supply lines LkV for input output lines LkV line s to line s 2kV line s to earth lt 5 U gt 95 dip in for 0 5 cycle 40 U 60 T inU for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dipin U for 5s 6kV contact 8kV alr 2kV for power supply lines IkV for in
7. any uncomfortable pain for the patient e Apply a sufficient amount of coupling gel to the patient s skin in the coupling area and to the R SW shock transmitter e Perform treatment as described in 3 2 1 3 Indications list e Donot apply more than 300 400 shots to the same spot Make small circular movements with the hand piece on the place of the indication to avoid this e Avoid excessive pressure of the applicator to patient s skin Such pressure is not needed for successful treatment CAUTION Interrupt the treatment at the latest after 6000 shocks in R SW mode Tip of applicator may become hot gymna 4 4 Cleaning Maintenance and Overhaul 4 1 Cleaning Regular cleaning of the system ensures perfect hygiene and operation of the ShockMaster 500 CAUTION Disconnect the unit and the accessories from the mains before starting any cleaning and overhauling work e Wipe the exterior of the housing with a damp cloth Use soapy water or a mild cleaning agent ATTENTION It is essential to prevent fluid penetrating into the unit or its tubes NOTE Please refer to the separate operating instructions of the hand piece 42 gymna 4 2 Replacement mains fuse The holder of the mains fuse is located on the rear panel of the ShockMaster 500 e Push the clip of the mains fuse holder to the right and take the holder off the housing 230 VAC 50 60 Hz 2 6A N TI0AH
8. ia Bar rer Sharks D Actor menmen Tha patient fies ina prone podion Hirai fhe anplacetor stt high pressure ON puria of the Hi Gagtroonemicun until you achive good blood D ack 20 or imm 1 5 bar Schillocyrus meda lateral Gehe bet eee bias tiama fet hat Bey ir haar aa eel etm ke As h lles od Ch herder II a Cerin Crave ae Dei far y Or cokes bama that can lead to pan and owning Previous Close gymna 29 With the buttons at the bottom of the screen you can browse between the 3 pages Press Close to leave the INTO SCrEEN Load The indication you have selected will be loaded and the treatment screen will pop up automatically The name of the indication you have selected will come into sight at the left upper corner of the screen Ihe parameters are set and at the left handed side of the screen the corresponding image s will become visible Edit A screen similar to the New Indication screen will be opened All data are already filled out These date can be modified now You can only change indications you have added yourself The standard indications can not be modified Delete Only the indications you have added yourself can be deleted ger te Standard indications can not be deleted re mr hut vau ar den eg L A pop up screen will ask for a confirmation ds Ei You can confirm or cancel ga 3 2 1 4 Body area The 2nd menu is the Body Area menu The buttons a
9. of used marks and symbols see attachment pag 59 gymna 13 2 Installation 2 1 Unpacking Remove the equipment and accessories from the packaging container Proceed with extreme caution Check that all items are included in the packaging container and that they are not damaged Contact your supplier or the manufacturer immediately if any items are missing or damaged Retain the original packaging if possible It may prove useful for any later equipment transport 2 2 Scope of supply The standard scope of supply of the ShockMaster 500 includes the following Items ShockMaster 500 device trolley Complete R SW hand piece gel holder Mains cable Gel bottle Handle bar RSW hand piece 15 mm Classic applicator 20 mm D ACTOR applicator User manual of the ShockMaster 500 hard copy in English other languages available on CD Compressor Revision kit User manual of the compressor hard copy In English User manual of the hand piece hard copy in English Please refer to chapter 6 for information on ACCESSORIES AND SPARE PARTS 14 gymna 2 2 1 Connecting the compressed air supply ATTENTION The compressed air input pressure must be 6 0 7 0 bar If compressors other than the GymnaUniphy S A 50 TDC compressor are used this pressure must be checked on the compressed air supply system If the pressure exceeds 7 0 bar the system s overpressure protection will be tripped The compressed air must be dry oil f
10. 3 4 Functional checks oe Standard settings 3 6 Treatment 4 gymna Pe WO O O oo ooa Ao UJ HH 4 Cleaning Maintenance and Overhaul 41 Cleaning 42 Replacement mains fuse 4 3 Maintenance 4 4 Disposal 4 5 Repair 5 Status messages and trouble shooting al Status messages DE Trouble shooting 6 Accessories and spare parts 6 1 ShockMaster 500 6 2 Compressor 6 3 Accessories 6 4 Documentation re Technical specifications 71 ShockMaster 500 2 Identification plate ShockMaster 500 73 Conformity with directives 74 Conformity with standards 75 Directives 3 Warranty and service 8 1 Warranty oO Service Attachment Compressor Installation 60 gymna 5 1 General Information 1 1 Introduction This manual contains warnings safety instructions and specific operating instructions in accordance with liability regulations CAUTION Complete or partial failure to observe the instructions information or procedures preceded by the term CAUTION may cause injury or fatal accidents ATTENTION Complete or partial failure to observe the instructions information or procedures preceded by the term ATTENTION may cause equipment damage NOTE Additional information concerning specific features or operating instructions is preceded by the term NOTE 6 gymna CAUTION Before you start using the ShockMaster 500 for the first time please make sure you have read and under
11. V m 80 MHz to 2 5 GHz 80 MHz to 2 5 GHz IEC 61000 4 3 Electromagnetic environment guidance Portable and mobile RF equipment should be used no closer to any part of the ShockMaster 500 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2vP d 12vP 80 MHz to 800 MHz d 23vP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manu facturer and d is the recommended Separation distance in metres m Field strengths from fixed RF transmit ters as determined by an electromag netic site Survey a Should be less than the compliance level in each frequency range Db Interference may occur in the vicinity of equipment marked with the following symbol Er Pi h LI Jil i A NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation Is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base Stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electroma
12. a Push on the Update button until a small white arrow appears You also here a click Inside the unit Now the unit is ready for the update 38 gymna Transfer data Insert the memory stick where you have placed on the software update After a few seconds a popup will be displayed Update v 1 2 0 Update in progress Do NOT swith off the device or release the memory stick Finish transfer data Wait until the update is finished Check if you have the correct version loaded Release the memory stick and restart the device Check if the version Is correct Push the settings button and select info On the screen in the right there is indicated Software version X gymna 39 3 3 Start up NOTE Prior to start up please refer to the separate operating instructions of the hand piece e Switch on the ShockMaster 500 e Set the energy of the shocks to an Initial value of 2 bar e The maximum pressure Is limited to 5 0 bar The minimum pressure that can be set is 1 0 bar e Press the R SW hand piece button If everything Is connected well shocks are released Press the hand piece button again and the shock release will Stop 3 4 Functional checks Perform the following functional checks after the system has been installed e Check the control unit and hand pieces for damage e Start the ShockMaster 500 see chapter 3 3 START UP e Set the energy level to 2 0 bar e Reset the actual
13. affected by absorption and reflection from structures objects and people 7 5 Directives The device complies with the essential requirements of the Medical Devices Directive 93 42 EEC and the Waste Electrical and Electronic Equipment Directive 2003 108 EC of the European Parliament and of the Council as most recently changed gymna 57 8 Warranty and service 8 1 Warranty During the two years warranty period from the date of delivery of the product to the end customer defects will be remedied t no charge to the customer upon the customer furnishing adequate proof that the defect is due to defects in material or workmanship The warranty does not extend to wear parts Shipping costs and risk of loss of returned products shall be borne by the customer ATTENTION Any unauthorized opening repair or modification of the system by unauthorized personnel will relieve the manufacturer of its liability and responsibility for safe system operation This will automatically void the warranty even before the end of the warranty period 8 2 Service Should you have any further questions or require additional information please feel free to contact your dealer Attaclim nt Applied part typ B C E 0197 CE mark with registration number of the notified body SN Serial number REF Article number Main fuse 2009 MJ Year of manufacturing Manufacturer Do not dispose this electrical equipment
14. aster 500 such systems must be installed outside the patient treatment area Cleansing and disinfecting agents may generate an explosive atmosphere Disconnect the unit and the accessories from the mains before starting any cleaning and overhauling work Do not try to open the system Risk of electric shocks ATTENTION The unit is movable by a trolley on spot Take care for transport that the wheels are not blocked by brake or any parts on the floor and do not push the unit gymna gt 20 gymna ATTENTION Check that the installation surfaces have sufficient carrying capacity to avoid equipment damage Electric medical devices underlie special regulations regarding Electromagnetic Compatibility EMC Hence medical electric devices have to be installed and commissioned in accordance with the EMC guidelines detailed in the accompanying documents Portable and mobile HF communications equipment such as cell phones may cause Interferences with medical electric devices The use of accessories or cabling not authorised by the supplier may cause increased emissions or may lead to reduced interference resistance of the device The ShockMaster 500 must neither be deployed nor stored together with other devices If the operation near or jointly with other devices is required the ShockMaster 500 has to be tested against that particular environment to ensure operation according to technical specification Th
15. changed 13 09 2011 15 39 Language Handpiece Blue English Handpiece Yellow re f software update a Export Patient data Ok 3 Cancel 36 gymna The menu structure is as follows 1 General info Software version number Critical parts of the device l Languages German English Spanish French Italian Dutch Turkish Danish Czech Polish Russian Portuguese Swedisch Norwegian Time Date and time 4 Hand piece counter Black Number of shocks on channel Black Reset button to put on O 5 Hand piece counter Yellow Number of shocks on channel Yellow Reset button to put on O 6 V ALTOR counter Number of shocks done by the V Actor Reset button to put on O 7 Software update Click on the update button Insert the memory stick Wait until update finished Release the memory stick and restart the device BWN gymna 37 3 2 1 8 Software update 1 Start up the device and go to the setting screen Push on the settings button Info Language Time Handpiece Blue Handpiece Yellow 1 09 2011 15 40 Click on the update button 2 Insert the memory stick 3 Wait until update finished 4 Release the memory stick and restart the device V Actor Software update Export Patient data C Merrie Start the update Select Software update The following screen appears 3 Prepare the ShockMaster to receive dat
16. e ShockMaster 500 may be deployed and operated close to the listed accessories The system must only be connected to properly earthed and correctly installed shockproof sockets Check that the system is in perfect working order before each use see chapter 3 4 FUNCTIONAL CHECKS Never cover the system when In use Make absolutely sure that no liquid can seep into the system housing or hand piece Any damage to the unit resulting from incorrect operation Is not covered by the manufacturer s warranty Disposal of the system and its components must be carried out in accordance with national waste disposal regulations ShockMaster 500 must only be used with accessories that have been approved by the system manufacturer To prevent safety hazards unauthorized system modifications are not allowed This will void the CE mark approval and warranty NOTE The ShockMaster 500 meets the requirements of the applicable electromagnetic compatibility EMC standards EN 60602 1 2 These limits are designed to provide reasonable protection against harmful interference Ina typical medical installation The equipment generates uses and can radiate radio frequency energy If not installed and used in accordance with these instructions the equipment may cause harmful interference to other devices in the vicinity However there IS no guarantee that interference will not occur in a particular installation If this equipment does cause harmful in
17. ent temperature during storage and transport e Ambient air pressure e Air humidity e Control unit weight e Classification in accordance with MDD 93 42 EEC e Protection against the ingress of water EN 60601 1 50 gymna R SW Single shock 1 21 Hz 1 35 Hz with the V ACTOR steps of 0 5 bar from I to 5 bars 230 VAC 50 60HZ 10 AH time lag 100 240 VAC 5A max 500 VA 6 Dar 1 5 bar 10 C 35 C 20 C 60 C 500 1060 hPa 5 90 non condensing 8 kg lla IPX1 7 2 Identification plate ShockMaster 500 7 3 Conformity with directives This medical product bears the CE mark in accordance with the Medical Device Directive MDD 93 42 EEC 7 4 Conformity with standards EN 60601 1 ype of protection against electric shocks Degree of protection against electric Shocks PT gymna 5 EMC guidance and manufacturer s declaration Guidance and manufacturer s declaration electromagnetic emissions The model ShockMaster 500 is intended to use in the electromagnetic environment specified below The customer or the user of the ShockMaster 500 should assure that it is used In such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The ShockMaster 500 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any Interference in nearby electronic equipment
18. ge illustrating the treatment On top of the Indications list you can find the following buttons e Free Deselect the previous selected indication You will automatically be redirected to the treatment screen The parameters of the previous selected indication are gone and there is no image on the left side of the treatment screen e New Add a new Indication A new screen will appear In this screen you can name the new indication set the corresponding parameters and add extra remarks gymna 27 Press OK or Cancel to leave this screen The new indication will only appear in the Indications list when you have saved by pressing OK New indications are in alphabetical order visible at the end of the list of standard indications Indication 13 09 7011 15 74 BETE E E A 2000 Sinmks 50 H eeoecoocoocooodc ececoocceocdo 28 gymna At the right side of the Indication screen you can find the following buttons e Info This screen will provide you with more detailed information about the indication you have selected The info is divided into 3 elements Treatment Protocol Phase 1 Treatment Protocol Phase 2 Medical information N i u le re Achille Tila TECH The patient da a prone positron Peia the prec rive eben tn rl fo pts t nk rg ahd at the brer face bohom the he Fi cis tur raat ce end Aurel herein Apy HON socka on wich aliia aac na Poti
19. gnetic site survey should be considered If the measured field strength D Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m gymna 55 Recommended separation distances between portable and mobile RF communications equipment and the ShockMaster 500 The ShockMaster 500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ShockMaster 500 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ShockMaster 500 as recommended below according to the maximum output power of the communications equip ment Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Rated maximum output d 1 2VP d 1 2VP d 2 3VP power of transmitter W 0 01 0 12 0 12 ika For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maxi mum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency applies NOTEZ These guidelines may not apply in all situations Electromagnetic propagation is
20. he selected patient A pop up screen appears asking u u Foe yeaa cule pour anti Es hebei to delete the patient yes or No hans Gravel ve de No 34 gymna 3 2 1 6 Anatomical library screen The 4th menu ts the Anatomical Library Access the anatomical library for anatomical information on the musculoskeletal system Select the body area you want to display information of After selecting a pop up screen will appear This information is only in English available a 2 6 oe Select an item from the list and push Ok Detailed anatomical information will pop up You can go back to the Anatomical Library by selecting Close eels Back Shoulder 92011 15 37 A Infraspinatus Lateral Ligaments Latissimus Dorsi Levator Scapulae Rhomboid Major and Minor Subscapularis Supraspinatus Teres Major Teres Minor Trapezius Cancel gymna 35 If you select a muscle the following information is available Origin Insertion Action Innervation Arterial Supply If you select a ligament or joint an anatomical picture with detailed information will pop up i Lateral Ligament Az p S wal ne f r lich mr fd das eran we maia f tim mil weet J or are Cr ach al clay sole Pape falters teed Loe i as Ch eg fishers 3 2 1 7 Settings screen The 5th menu Is the Settings screen In this menu all device settings can be
21. ided on the ShockMaster 500 ATTENTION Consider the colour marks Connect the hand piece with the black mark on the cable only with the black output channel The yellow channel can be used for an extra hand piece or a V ALTOR e Make sure that the red spots on the connector match the red spots on the hand piece connector e Place the hand piece in the hand piece holder NOTE Please refer to the separate operating instructions of the hand piece gymna 17 3 Operation 3 1 General warnings and safety information 18 gymna CAUTION The ShockMaster 500 is exclusively intended for use by medical specialists and must only be used by suitably qualified and trained medical personnel see also chapter 1 2 PRECONDITIONS TO OPERATE THE ShockMaster 500 The user is responsible for correctly positioning the hand piece of the ShockMaster 500 It is the user s responsibility to determine correctly where the treatment zone is located The ShockMaster 500 must only be used for applications approved by GymnaUniphy To avoid safety hazards use of the system for applications other than those specified in chapter 1 1 1 INDICATIONS is not allowed Do not use the ShockMaster 500 in potentially explosive environments i e in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide If systems other than medical devices in accordance with EN 60602 are connected to the ShockM
22. ight up to indicate in 90 how many shocks of the total number of shocks assigned have already been given yo Fa u re a j d 4 ee F ja Fee et a NN A ze See Graphic representation of an uploaded indication when loading an indication see p 29 the corresponding image will show up at the left part of the treatment screen NOTE The pre programmed parameter settings indications are based on experiences from medical experts or physiotherapists These are indicative and can be used as an example but can be adjusted to own expertise Attention at own risk of the operator gymna 25 At the end of treatment the following question will pop up Save session Here you can choose to save the data of the session in your patient database Note only when you have selected a patient see p 33 These data will be saved e Date of treatment e Name of the indication which was loaded e Selected parameters If the parameters have been changed after the loading of the indication the changed values will be saved e VAS score See p 33 26 gymna 3 2 1 3 Indications list Indication 13 09 2011 10 01 r CD Plantar Fasciitis Shin Splints Tibial Edge Syndrom Subscapularis Tendinitis Suprapatellar Tendinopathy Supraspinatus Tendinitis Trigger Points a The first button is the Indications List An indication consists of pre programmed parameter settings and an ima
23. long Mains cable e Mains cable CEE 7 Europe 2 5 m long e Mains cable CH 3 m long e Mains cable USA 3 m long e EC coupling 1 m long between control unit and compressor NOTE For information on the R SW hand piece and Its accessories please refer to the separate operation manual of the R SW hand piece 6 2 Compressor S A 50 TDC Compressor e SA 50 TDC compressor 230 VAC e SA 50 TDC compressor 115 VAC 48 gymna 6 3 Accessories ShockMaster 6mm acupuncture applicator ShockMaster 15mm applicator Revision Kit metal 17212 ShockMaster Revision Kit MA X 17888 ShockMaster ShockMaster 15mm applicator MA X ShockMaster D ACTOR applicator ShockMaster D ACTOR applicator ShockMaster Deep Impact applicator ShockMaster RSWT focus lens set ShockMaster V ACTOR 25 mm applicator set ShockMaster V ACTOR 40 mm applicator set ShockMaster V ACTOR handpiece 25 and 40 mm applicator included R SW hand piece 1 metal projectile tube included 6 4 Documentation User manual ShockMaster 500 User manual hand piece User manual V ACTOR User manual compressor gymna 49 7 Technical specifications 7 1 ShockMaster 500 e Operating mode R SW e Energy selection R SW e Mains input voltage e Mains frequency e Mains fuse e Auxiliary outlet e Power consumption with auxiliary device e Compressed air Supply e Compressed alr output e Ambient temperature during operation e Ambi
24. n the parameters are shown You can upload a pre programmed Set of parameters from the list of indications please check chapter 3 2 1 3 Indications list For each indication there Is a graphical representation of the treatment When loading an indication the graphical representation will appear on the left hand side of the treatment screen EpiLlat M ExtCr Brev tenopenost Fede Parameters 2000 socis mi gymna 23 The following parameters can be set e Pressure 1 5 bar Adjustable by steps of O 1 bar e Number of shocks 1 20000 shocks adjustable by steps of I shock between 1 10 shocks 10 shocks between 10 100 shocks 100 shocks between 100 20000 shocks unlimited amount of shocks e Frequency 0 5 21Hz V ACTOR 0 5 35Hz adjustable by steps of 0 5Hz for a frequency lower then 10Hz 1Hz for a frequency higher then 10Hz The frequency of 35 Hz can be set at any moment but will only be active when using the V ALTOR If you use the hand piece the frequency will be automatically reset to 21 HZ the maximum frequency for the use of the hand piece With the reset button you can reset the number of actual shocks to Q A pop up screen will appear and you can confirm or cancel During the treatment you can adjust the parameters During the treatment you can NOT activate another menu 24 gymna Below the parameter Number of shocks is a bar with LEDS On this bar LEDS will l
25. number of shocks on the parameter display of the operating panel see 3 2 1 2 1 Parameters e Release shocks In continuous shock mode shock frequency 5 H2 15 Hz e Check that the triggered shocks are correctly counted on the treatment shock counter 3 5 Standard settings e Before each treatment make sure that the number of shocks and the actual energy value are set to zero See chapter 3 2 1 2 1 Parameters e Start the R SW treatment at a pressure of 1 8 bar and a frequency of 15 Hz e he number of shocks to be applied for trigger point shockwave therapy TrST differs from ESWT treatment Such therapies must only be performed by suitably qualified and trained personnel With the pre programmed myofascial indication there are an ulimited amount of shocks predefined 40 gymna 3 6 Treatment CAUTION Always read chapter 3 1 General warnings and safety information before starting a treatment Please refer to the separate operating instructions of the hand piece Each time after the ShockMaster 500 has been transported make sure that all functional checks have been performed on the unit before you start treatment To avoid safety hazards use of the system for applications other than those specified in chapter 1 1 1 INDICATIONS is not allowed All status and error messages appear during treatment must always be attended to without delay NOTE The use of maximal energy level during treatment must not result in
26. ockwaves must not be applied to target areas located above air filled tissue lungs nor to any regions near large nerves vessels the spinal column or head 1 1 3 Side effects Treatment with the ShockMaster 500 may cause the following side effects e swelling reddening haematomas e petechiae pain e skin lesions after previous cortisone therapy These side effects generally abate after 5 to 10 days 1 2 Prerequisites for operating the ShockMaster 500 1 2 1 Operator The ShockMaster 500 is intended exclusively for use by Dara medical specialists or physiotherapists and is only allowed to be used by qualified and instructed medical persons Such a specialist is expected to have practical knowledge of medical procedures and applications as well as of the technology and should be experienced in treating the indications stated in chapter 1 1 1 The specialist must have the basic physi caland cognitive prerequisites such as vision hearing and reading Furthermore the basic functions of the upper extremities must be guaranteed Ihe device is designed for a demographic target group be tween 18 and 65 years 1 2 2 Training of the operator Operators of the ShockMaster 500 must have been adequately trained in using this system safely and efficiently before they operate the device described in this handbook An introduction to the principles of operation Is provided by the GymnaUniphy dealer with reference to the operating manual
27. put output lines LkV line s to line s 2kV line s to earth lt 5 U gt 95 dip in U for 0 5 cycle 40 HU 60 dip in U for 5 cycles 70 KU 30 dip in U for 25 cycles lt 5 U gt 95 dipinU for5s 3 A m U_is the a c mains voltage prior to application of the test level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the ShockMaster 500 requires continued operation during power mains inter ruptions it is recommended that the ShockMaster 500 be powered from an uninterruptible power supply or a battery The power frequency magnetic field should be that of a typical commercial or hospital environ ment gymna 53 Guidance and manufacturer s declaration electromagnetic immunity The model ShockMaster 500 is intended to use in the electromagnetic environment specified below The customer or the user of the ShockMaster 500 should assure that it is used in Such an environment Conducted RF 3 Vrms 3 Vrms 150 kHz to 80 MHz 150 kHz to 80 MHz IEC 61000 4 6 Radiated RF 3 V m 3
28. re linked to several body areas Every body area contains several indications After selecting a body area a pop up screen will appear 30 gymna Shoulder Supraspinatus Tendinitis Infraspinatus Tendinitis Subscapularis Tendinitis Bursa Subdeltoidea Ok amp Cancel Every Indication is supported with an anatomical image related to the muscle area of the indication Select the desired indication and select ok The program immediately goes to the Treatment Menu No indication can be added or deleted There is no possibility to check more information of a selected Indication Also there is no possibility to activate the Tree mode 3 2 1 5 Patient database Patient 13 09 2011 15 30 Free Hans Gravels salem The 3rd menu is the Patient database It looks and operates quiet similar as the Indication menu gymna 3 On top of the Indications list you can find the following buttons e Free Deselect the previous loaded patient You return automatically to the treatment menu e New Add a patient A new screen appears In this screen you can add the patients name address or extra remarks Remark You can only use 25 characters for adding the name of the patient Confirm with OK to leave this screen The new patient will be added to the list when pressing OK Patient Birthday 060 OOOO Ceoeeqcocoecodcod ere reco cv oo 32 gymna
29. ree and filtered to lt 5 micron Never use CO2 gas for compressed air Supply If compressed air is Supplied through a wall outlet use a pressure reducer max bar if necessary e Connect the compressed alr tube to the compressed air connector provided on the compressor e Connect the compressed alr tube to the compressed air tube connector provided on the rear side of the ShockMaster 500 until it audibly engages gymna 15 ATTENTION when setting up the unit make sure that the air outlets on the housing of the ShockMaster 500 are not blocked 2 2 2 Connecting the power supply cables An external compressor has to be controlled by the ShockMaster 500 via the mains power link cable Compressor Installation see page 58 e Connect the compressor via the mains power link cable to the auxiliary outlet of the ShockMaster 500 1 e Connect the ShockMaster 500 via the mains cable to the mains connector 2 ern er Aa a oe T10AH 250VAC ATTENTION Use both power connectors only for connecting the compressor 1 or Shockmaster 500 2 Do not connect any other electrical equipment 16 gymna NOTE The compressor is automatically switched on and off with the ShockMaster 500 During first installation make sure that the mains switch of the compressor is in ON position 2 2 3 Hand piece connection e Connect the connector of the R SW hand piece to the hand piece connector prov
30. stood all information provided in this operating manual Familiarity with the information and instructions contained in this manual is an essential requirement to ensure efficient and optimal use of the system to avoid dangers to persons and to the equipment and to obtain good treatment results Thorough knowledge of the information included in this manual will also enable you to react promptly and effectively in case of malfunctions and failures When using optionally available accessories please also refer to the separate operating manuals for each of these accessories Knowledge of the content of this manual is an essential prerequisite for operating the entire system The ShockMaster 500 is a compressed air operated ballistic shockwave generator featuring high precision ballistic components in its applicator for shockwave generation The motion and weight of the projectile accelerated by compressed alr produce kinetic energy that is converted into sound energy when the projectile strikes an unmoved surface shock transmitter This acoustic pulse is transmitted to the target tissue directly as well as by means of an acoustic impedance adapter shockwave coupling cushion or gel These waves are physically classified as radial pressure waves Ihe applied pressure pulse propagates radial within the tissue and has a therapeutic effect on areas of the tissue near the surface in particular NOTE Medical devices operating on the basis of
31. terference with other devices which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving device Increase the separation between the equipment Connect the equipment into an outlet on a circuit different from that to hich the other device is connected Consult the manufacturer of fleld service technician for help 3 2 Operation The ShockMaster 500 is operated by using a color LCD monitor with touch screen function 3 2 1 The user interface 3 2 1 1 Introduction The user interface is divided into 1 main screen treatment screen and 5 menu screens When switching on the device you automatically enter the main screen treatment screen You can use the 5 control buttons at the bottom of the screen to display a menu The selected control button will turn blue and the requested menu is activated To leave the menu push the control button again gymna 2 1 0 2011 10 04 Control button to activate the Indications List screen Control button to activate the Body Areas screen Control button to activate Patients Database screen Control button to activate Anatomical Library screen Control button to activate Settings screen 22 gymna 3 2 1 2 Treatment screen The treatment screen consists of 2 parts At the right hand side of the treatment scree
32. the above principle are generally referred to as extracorporeal shockwave systems in modern medical literature gymna 1 1 1 Indications The ShockMaster 500 is designed for extracorporeal treatment by means of low to medium energy radial shockwaves Indications include e Biomechanical therapy e Myofascial trigger points MTrP e Disorder of tendon insertions e Activation of muscle and connective tissue e Acupuncture shockwave therapy Qualified training in acupuncture and acupuncture shockwave therapy AkuST is required for therapeutic application of the ShockMaster 500 in the fleld of acupuncture A sound knowledge of trigger point therapy and trigger point shockwave therapy TrST is required for therapeutic application of the ShockMaster 500 in the field of trigger point shockwave therapy 1 1 2 Contra indications CAUTION The contraindications listed here are examples No claims are made regarding the completeness or unlimited validity of this list of contraindications Treatment with the ShockMaster 500 Is not permitted in the following cases e coagulation disorders haemophilia e use of anticoagulants especially Marcumar e thrombosis e tumour diseases carcinoma patients e pregnancy e polyneuropathy in case of diabetes mellitus e acute inflammations pus focus in the target area e children in growth e cortisone therapy up to 6 weeks before first treatment gymna CAUTION Sh
33. with general house hold waste General warning sign ISO 7O010 WOO1 Read the manual Do not push gymna 5 Compressor Installation Preparation of the compressor Fig I Remove red cap transport protection Fig 2 Assemble air filter Fig 3 60 gymna Fig 4 Connect air hose if It is separately Fig 5 Fig 6 gymna s Trolley with compressor Fig Open the sliding door at the Trolley Fig 8 62 gymna Fig 9 Put the compressor into the Trolley like it is Shown in fig LO to 12 Fig LO gymna 63 Fig 11 Fig be earth wire I compressor chassis earth wire 2 chassis sliding door 64 gymna Fig 13 Connect earth wire 1 Fig 14 Connect earth wire 2 Fig 15 gymna 65 Fig 16 Lay the air hose and the power cord of the compressor upward Fig 17 Close the sliding door 66 gymna Fig LO Fig I9 Connect air hose and power cord to the device nockMaster 500 gymna 67 Emptying of the bottle with condensation water Fig 20 Fig el Fig 22 Open the bottle with rotary lock 68 gymna Fig 23 Empty the bottle place It into the Trolley and close It Fig 24 gymna 9 70 gymna gymna 7 gymna GymnaUniphy NV Pasweg DA 3740 Bilzen Belgium 1 320895105E0 F 32 0 89 510 511 info shockmaster eu www shockmaster eu
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