USER MANUAL kimatur - Mikro Polo Market
Contents
1. The system was developed using the latest technical and clinical knowledge REV 4 06 06 2013 page 11 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 3 System Preparation 3 1 Standard Accessories Handpiece with hose connection Power Cable User Manual Contact Gel 1 spare set of fuses 1 Applicator S metal 1 Applicator M metal 1 Applicator MTrigger metal 1 Applicator XL REV 4 06 06 2013 page 12 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 3 2 User Interface Main Menu 2 3 4 5 6 7 1 8 Favoriten Bibliothek Einstellungen Picture 1 Kimatur Main Menu 1 Home 2 Patient database 3 Favourites 4 Therapy 5 Indication Library 6 Device Information 7 Device Settings Service Menu 8 Return button visible in all submenus REV 4 06 06 2013 page 13 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur Therapy Mode 10 13 11 14 11 16 LO 17 15 11 Clear Real Shot 12 Shots Count in Real Time 13 Channel Activated 14 Start and Stop Button 15 Pressure Setting 16 Save to Patient Database 17 Save to Favourites 18 Frequency Setting 19 Mode Selection REV 4 06 06 2013 page 14 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur Modulation Selection There are three available pressure frequency modulatio2. 5 2 User Manual kimatur USER MANUAL kimatur Radial Shockwave Therapy REV 4 06 06 2013 page 1 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur Contents 1 Safety Regulations iii 4 1 1 Application Requirements Vi 4 1 2 General Information sis 4 to Ie ROTE 5 1 4 Packaging and Disposal of the Device 5 2 Applicaton and F RCUON ne nee RE SM xad RUE 5 2 1 Application and Further Information cccccceccseeceeeceeeeeeeeeeeeeeeteeeteeeteeenees 5 2 1 1 Technology DOSCHDUON 5 2 1 2 Physiological Effects Of RSWT nennen 6 2 1 3 16 11672 o rr Q 6 2 MEME Viet m RE 7 2 1 5 Not Suggested from the view of clinical results use on to 7 2 1 6 QUICK Therapy Guide RL 8 2 2 Function Information sise 11 3 SICI Ir FD all AMO RR cm 12 9 1 Standard Accessories euis dines aeiviendeis ancre memes encres corn isk Misi pta UE 12 3 2 User MIETE uec D E 13 33 SO OS NENU eran ee ee ee 16 CE eile ERU 16 SPEM e adii GAM ON DAC REDEEM 18 3 0 SYMBOL DOSCIDHOD senes ee ee 18 of Kinatur MEM GDS CO uecenscoiivopcibisunctux Tera vrati tne nest n MpFEFINI REI Tus ta RU V oUHEEIME SEE 19 4 Installation and Assembly and Operation Hazards 20 4 1 Handpiece Conrie Hol sucus nicus here tn a ERR UP Ru AR Vx Fa SR HE Coa ICE 20 4 2 Operation Hazards iii 20 REV 4 06 06 2013 p
3. Effects of RSWT The discovery that RSWT applications produced important responses at the infra cellular level changed the concept on their action from pure physical mechanical implications to profound action mechanisms in tissues Specifically it has been found that RSWT promotes e Neovasoularization RSWT increase the expression of angiogenic growth factors such as the Vascular Endothelial Growth Factor VEGF as well as the Proliferating Cell Nuclear Antigen PCNA e Improvement to the micro circulation RSWT mechanically stimulates the intrinsic movement of the smallest terminal vessels in the micro vascular system This action is an elementary characteristic of micro angiodynamics that allows the blood flow through the vascular bed to be regulated e Increase of the cells membrane permeability as a result of the delivered shots e Bone remodelling and regeneration has been clinically proven Investigation on the physiological mechanism is in progress and it appears to correlate the clinical benefit to the decrease of the expression of DKK1 gene Wang et al 2008 e Decrease of pain sensation combined with lessen of the muscle strain Prevailing theories suggest that shockwave therapy actions up reorganization of pathologically stored information related to chronic pain making possible lasting relief of it SW action expands to reflex based reactive processes to pain resulting in afferent algogenic signals to be transmitted and stored Afferent
4. age 2 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur NC M ee ee Be ee ee 21 5 1 Bru e E ee ee 21 5 2 Handpiece and Applicators seen 21 SEE INCURSU m 22 SCT A LH 22 D2 Sale CHECKS ee ee ele nee eee eee ee ee 22 09 UENIRE 23 NN TOUDE SOONG EUN mm 24 9 JEndorlfe time ScrappiRd n ans nenne 25 9 Technical Dale ee ee nee ein 26 REV 4 06 06 2013 page 3 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 1 Safety Regulations 1 1 Application Requirements Please read the following instructions carefully The application of shockwave requires clinical knowledge and it should only be used by appropriately trained users Improper handling from users may cause serious harm to the patients Training can be offered by TUR on request 1 2 General Information Attention Before starting the device the user manual should be carefully read and the instruction should be well comprehended The manufacturer is not liable for any direct or indirect material or personal damage due to improper use or maintenance Warning kimatur is a sophisticated medical device which is produced under constant quality control Proper care and maintenance is essential for safe use of medical devices The manufacturer recommends that upon receipt and before each use the user should make a careful examination of the equipment and accessories for prop
5. creased Start with lower pressure and increase up to 2Bars depending on patient s acceptance REV 4 06 06 2013 page 8 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur Plantar Fasciitis Plantar fasciitis is inflammation of the thick tissue on the bottom of the foot This tissue is called the plantar fascia It connects the heel bone to the toes and creates the arch of the foot Plantar fasciitis occurs when the thick band of tissue on the bottom of the foot is overstretched or overused This can be painful and make walking more difficult Increase the frequency to the last 300 shots and scan the whole region of the plantar fascia regardless the pain area Achillodynia The pain in the Achilles tendon or its bursa Mainly due to inflammation of the heel cord that is the extension from the triceps surae group of muscles characterised by simultaneous swelling along the tendon sheath proximal to the calcaneus mes oe Wu Sessions Week Treat Achilles tendon to its full Increased number of shots can be applied Apply moderate pressure during therapy REV 4 06 06 2013 page 9 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur Radial Ulnar Epikondylitis A painful and sometimes disabling inflammation of the muscle and surrounding tissues of the elbow caused by repeated stress and strain on the forearm near the latera
6. ed representatives To ensure both patient and user safety it is necessary to follow certain maintenance procedures They are also necessary to maintain the safety and functional features of the system 6 2 Safety checks 1 The operator of medical devices for which the manufacturer has requested regular safety checks must perform as specified by the manufacturer and the generally recognized rules of technology and in the time periods specified by the manufacturer The operator has to perform the safety checks in accordance with generally accepted engineering standards and on the basis of the experience must be carried out that possible defects can be detected well ahead The safety check should not be carried out later than every two years to The safety controls include the measurement functions 2 The operator must follow authorities that specify shorter periods than mentioned in paragraph 1 3 A record that contains the date of execution and the results of the safety inspection indicating the measured values the methods of measurement and other assessment results must be created The protocol has to keep by the operator at least until the next safety inspection 4 A safety inspection may be carried out only by persons 1 who have a record of sufficient training skills and practical work experience to be responsible for the proper implementation of safety controls 2 whois not subject to external influence or conflict of other inte
7. er operation and good condition to prevent injuries to patient or to operator During therapy and in case the patient feels uncomfortable either due to pain or to any other reason therapy should be immediately terminated Warning The function of kimatur may be distorted by electromagnetic interference higher than 3V m Special attention should be paid while using devices such as mobile phones or other systems in Kimatur environment which exceed the standard EN 60601 1 2 specified values Also seldom EMV disturbances can cause a switch of the whole system In this rare case please restart the device setting the shock number at the remaining number REV 4 06 06 2013 page 4 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur New devices and new equipment must be cleaned before first use The contents of this user manual may be subject to technical changes without prior notice This document may only be copied and its contents may be used commercially with TUR s written agreement 1 3 Accessories Kimatur may only be used with accessories provided by the manufacturer There is high safety risk when unappropriate accessories are used Please contact your local dealer or distributor for a price list of the Kimatur accessories if one needs to be replaced 1 4 Packaging and Disposal of the Device Keep the original packaging of the kimatur up to its permanent disposal You can always use
8. fibres also control muscle tone associating pain and muscular tone from the view of therapeutic results 2 1 3 Indications The list of indications for shock wave treatment keeps increasing as research all over the world explores new therapeutic possibilities of the technology Main indications are e Achilles tendonitis e Calcified tendonitis e Radial and ulnar humeral epicondylytis e Patellar tendonitis e Plantar fascilitis e Chronic tendinopathy e Anterior tibial syndrome e Acupuncture shockwave therapy e Myofascial trigger points e Delayed unions REV 4 06 06 2013 page 6 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur e Lateral epicondylitis tennis elbow e Non unions e Osteonecrosis of the femoral head e Peyronie s disease e Rotator cuff tendonitis shoulder pain e Stress fractures e Wound healing e Pseudoarthrosis e Dupuyten s disease e Cellulitis 2 1 4 Contraindications e Pregnancy e Children in growth e Tumor diseases e Acute inflammations e Thrombosis phlebitis e Coagulation Disorders e Use of anticoagulant e Prolonged Cortisone therapy e Non Cooperative patients 2 1 5 Not Suggested from the view of clinical results use on to e Patients with conditions that lead to poor tissue quality such a fibromyalgia and irritable bowel syndrome e Organs with air filled cavities such as the lungs e Vertebrae especially the cervical ones e Open scars e Big b
9. he power supply and test it again If the device does not work properly after implementing the aforementioned actions please contact the manufacturer REV 4 06 06 2013 page 24 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 8 End of life time Scrapping Unlimited as long as both the maintenance requirements and replacement of parts that are mentioned in the Chapter are fulfilled Check you national regulation for discarding electronic devices REV 4 06 06 2013 page 25 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 9 Technical Data i 10 C to 40 C Maintenance On a predefined number of shots Relvehumdiy 25 1085 Additional conditions transport only in the original packaging External exchangeable fuse 2A Design Complete unit dimensions w x h x d Main unit dimensions w x h x d 290 x 220 x 365 mm Dimensions Screen w x h x d 400 x 355 x 40 mm IP code according to EN 60 529 IP 20 Display units Graphic colour touch screen diag 12 1 30 7 cm resolution 600x800 pixels REV 4 06 06 2013 page 26 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany
10. imatur Operation via touch screen The start stop function has no time delay The treatment ends for the safety of patients at each 99 999 shot bound The number of shots may be at any time set to zero by pressing the Clear Real Shot 11 27 Power socket and on off switch with fuse holders 28 Handpiece socket 29 Data transfer cable connected to Touch Screen REV 4 06 06 2013 page 17 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 3 5 Identification plate go IE TUR Therapietechnik GmbH i TU R val Grubenstrasse 20 Nee Nee 18055 Rostock Radial extracorporeal wave therapy unit kimatur e Unit de th rapie d onde radiale extracorporelle Item no article no 488600 Serial no no de s rie xxxxxx Transport and storage conditions Les conditions de transport et de stockage ambient temperature temp rature ambiante H atmospheric pressure pression atmosph rique 10 C 40 C 10 96 95 96 500 hPa 1060 hPa C W A Made in Germany 0482 Zus 2012 Fabriqu en Allemagne 3 6 Symbol Description Alternating Current C This product conforms with the Directives for medical products 0482 93 42 EWG Accompanying documents Disposal in accordance to the disposal directives for electrical and electronic devices wo Production Date year REV 4 06 06 2013 page 18 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Man
11. l epicondyle of the humerus Palpation of the painful area should be performed to define the treatment area Trochanteric Bursitis Trochanteric bursitis is characterized by painful inflammation of the bursa that is located just superficial to the greater trochanter of the femur Patients typically complain of lateral hip pain although the hip joint itself is not involved because pain may radiate down the lateral aspect of the thigh Apply moderate to high pressure while treating the area Preferably use applicator MT REV 4 06 06 2013 page 10 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur Trigger Points Myofascial Pain Syndrome Myofascial pain syndrome is a chronic pain disorder In myofascial pain syndrome pressure on sensitive points in muscles trigger points causes pain in seemingly unrelated parts of the body This is called referred pain Myofascial pain syndrome typically occurs after a muscle has been contracted repetitively This can be caused by repetitive motions used in jobs or hobbies or by stress related muscle tension Do not apply pressure on the point Each point should be treated with 1000 shots at 4Hz and then the whole area should be treated with 15Hz 2 2 Function Information Kimatur e is a microprocessor controlled unit The number of shots the pressure and the frequency are all carefully controlled by a complex electronic structure
12. lood vessels such aortae e Un precise and non palpable pain area REV 4 06 06 2013 page 7 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 2 1 6 Quick Therapy Guide Calcified Shoulder Tendonitis Calcific tendonitis is a condition that causes the formation of a small usually about 1 2 centimetre size calcium deposit within the tendons of the rotator cuff These deposits are usually found in patients at least 30 40 years old and have a higher T in diabetics M Sessions Week Note Ultrasound localization of the calcification is strongly suggested Otherwise X ray is necessary to confirm the exact position of the calcific deposits After delivering the 2000 shots it is suggested to treat all the shoulder area with low pressure e g 0 5 bar with further 500 shots to increase the blood circulation of the area Patellar Tendinopathy Patellar tendinopathy is a common and significant syndrome encountered in sports medicine Referring to a clinical condition characterized by activity related anterior knee pain associated with focal patellar tendon tenderness patellar tendinopathy is believed to result from repeated loading of the knee extensor mechanism and is thus most prevalent in sports involving some form of jumping Shots 2000 Sessions Week 1 Note Palpation of the pain area prior to therapy is necessary The number of shots can be in
13. ns in kimatur e Continuous Pressure and Frequency are steady e Saw Maximum and Minimum Values for Pressure and Frequency need to be selected e Hi Low Maximum and Minimum Values for Pressure and Frequency need to be selected 20 Continuous 23 Selection of Pmax and P min 21 Saw 24 Selection of Fmax and Fmin 22 Hi Low 23 24 REV 4 page 15 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 3 3 Settings Menu Einstellungen gt Ger teinformation Andale nam version Lietint a hw 20 96 47 image OO New 2010 25 OS Version Windows CC 50 Sound Processor Marvel PANO Ger telnformation gt Prag anm Min 21 2011 m Kazuma axe Toriras Hoe 23 2011 TUE Coptr ol dg Import Export Database Maw 21 2611 dh DataliassfiaM Bimm H armes More 21 2011 EG Paz i bog cdi Fab Mire 24 2011 ne Madre Sert Muy 212011 106 Sere res dil Sw Ariane 3 02 25 Firmware amp Software Versions 26 Device amp Hand piece Shots 3 4 Operation Operation via the handpiece Start Keep the button of the handpiece pressed for more than 3sec The compressor starts After 5 more sec the handpiece starts working The operation stops automatically when the preset number of shots is reached Stop Keep the button 19 pressed for 3 Sec The device stops working REV 4 06 06 2013 page 16 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual k
14. rests 3 has access to appropriate measuring and testing equipment 5 The operator shall appoint only persons who fulfill condition stated in 4 1 3 REV 4 06 06 2013 page 22 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 6 3 Maintenance The maintenance should be performed by authorised personal only Maintenance Instructions can be found in the Service Menual Section 4 Please contact your local TUR distributor for the service The service should be performed according the operation interval schedule underneath Maintenance Performed from Item Interval Action Reason 250 000 Service Staff Local O Rings Wear Replacement Shots Representative 1 500 000 Service Staff Local Applicator Wear Replacement Shots Representative Tube and 750 000 Service Staff Local n Wear Replacement Projectile Shots Representative 24 Months unless local Main Unit Control Unit AGR Safety check By authorized staff recommend shorter intervals TUR provides on request to service companies which are authorized by TUR the service manual and related drawings To be sure that your device works properly always follow the manufacturer s instructions when you change the O rings or the applicators The manufacturer may be considered liable for the safety and reliability of the kimatur only if the unit is connected to a regular outlet with earthing contact note VDE 0107 the de
15. the original packaging for the transport or storage of your system This device contains no harmful components Please remember to comply with the applicable disposal regulations of your country when throwing away the whole system its accessories or its packaging 2 Application and Function 2 1 Application and Further Information 2 1 1 Technology Description Radial Shockwave Therapy is a non invasive procedure to be administrated to outpatients for a variety of neuromuscular pathologies A shockwave is an intense rapid energy wave Differing from patient to patient s sensitivity threshold to pain the targeted region might be subject to local anaesthesia How are kimatur pressure waves generated A specially designed projectile is accelerated by means of a precisely burst of compressed air The energy of the projectile is transferred into the tissue through an applicator installed at the handpiece Through the applicator the energy is administrated to the region to be treated The pressure is regulated by a pump valve system to ensure constant delivery of the preset pressure value There is no connection between the pressure and the energy generated by a SW device The actual energy transfer is dependent on the material of the applicator and the technological solutions adopted during the design REV 4 06 06 2013 page 5 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 2 1 2 Physiological
16. ual kimatur 3 kimatur handpiece 30 Start Button 31 Applicator 32 Applicator Cap REV 4 06 06 2013 page 19 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 4 Installation and Assembly and Operation Hazards 4 1 Handpiece Connection Warning For safety reasons the handpiece should never been connected to the device during maintenance Connect the power cable to the socket 20 of kimatur and then to the power supply The socket of the power supply has to fit to the power cable An earth contact has to be guaranteed on the socket of the power supply has to be guaranteed Turn on the power switch 20 After switching on the system the compressor runs a system check The touch screen lights up after you hear a beep sound and the company logo appears after 30 seconds The device is ready for use and therapy can start 4 2 Operation Hazards Warning The device should not be used in sensitive body areas or to areas where internal organs can be affected Warning Ensure that the ventilation slots on the device are not covered Warning It is important to have the system off when you change applicator REV 4 06 06 2013 page 20 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 5 Cleaning 5 1 Device The control panel of kimatur e can be easily cleaned with a soft cloth dampened with water If necessary
17. vice is used in accordance to the instructions Extensions readjustments or modifications are performed only by authorized persons REV 4 06 06 2013 page 23 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 7 Trouble Shooting System does not turn on Inspect Power Cable for apparent wear Check fuses and replace if neccesary e Tochange the fuses you do not need to open the device e Disconnect the main supply cable e The fuses can be found next to the main switch 20 e To open the fuse holder use a flat screw driver and carefully put it in the slot of the fuse holder Open it by applying minimum force e Pull the fuse holder out e Replace both fuses with identical ones Put the fuse holder back and push to lock it 1 set of fuses is icnluded in your device Contact the manufacturer The display does not turn on Turn off the device Check if the power cable is properly connected to the mains and to the device Run a system check Turn off the system and check the condition of the data transmission cable Contact the manufacturer The performance of the handpiece has deteriorated Change Applicator Cahnge the projectile acceleration tube Check the connection hose 27 for distortion narrowing or other apparent damages Contact the manufacturer The unit does not turn off Unplug the power cord from the unit and wait 30 seconds Then connect the unit to t
18. you can use a liquid non corrosive solvent or a scratch free cleaning agent eg window cleaner or plastic cleaners Ensure that there is no liquid leakage in te device Carefully dry 5 2 Handpiece and Applicators The handpiece can be cleaned as the device with a soft dampened cloth If necessary you can use a liquid non corrosive solvent or a scratch free cleaning agent eg window cleaner or plastic cleaner To clean the applicator remove it from the applicator cup Unscrew the cup and dismantle the applicator and carefully clean seperately Intended use should only be applied to intact healthy skin Disinfection has to be performed in accordance to the national regulations for cleaning components that come in contact with healthy skin In most cases cleaning with mild alcohol containing detergent is required Ensure that there is no liquid leakage in te device Carefully dry e Handle the applicator cautiously Rough Handling can affect its operation e Do not bring the applicator in contact with sharp or pointed objects REV 4 06 06 2013 page 21 TUR Therapietechnik GmbH Grubenstr 20 18055 Rostock Germany 5 2 User Manual kimatur 6 Maintenance 6 1 General Before any maintanance action the device should be disconnected from the main The unit and the handpiece should not be opened for any reason by an unauthorized person All maintenance and repair work must be performed only by TUR Therapietechnik GmbH or authoriz
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