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VAS – 07 &bdquo;BETTER FUTURE“ edition

1. 47 I 1 mPha ri Lum W gt gt C cK cri Im iu cu m Within the framework of this offer 8 indication groups are presented according to the following table International nomenclature English names Morbi vertebrogenae Vertebrogenous diseases Morbi degenerationae Degenerative diseases Morbi inflammationae Inflammatory diseases Peripheral arterial circulatory disorders and disorders Morbi vascularae et lymphae of lymphatic circulation Traumae et suae sequelae Traumas and their consequences Morbi musculae et neuralae Disorders of skeletal muscles and peripheral nerves Enthesopathiae et alium Entezopathy and other indications diagnoses You can move through the menu by arrows A 13 V 14 and selection is confirmed by pressing the button 12 If for example the Morbi vertebragenae item is selected in this manner the next menu will appear Cx eR dm 1l cto RISE COW ons 5 a ot M 21 3n 0 gt User s Manual VAS 07 BETTER FUTURE edition 43 This menu shows all diagnoses associated with spine disorders which can be therapeutically influenced by DE administered by the device VAS 07 BETTER FUTURE edition Other item can be selected and confirmed for example Lumbalgia and the next menu will appear 3 pulse and 3 interference electrotherapeutic currents appear in the tabular form Parameters o
2. Miyorelaxatio Neuropathia Qbstipatio atonica Obstipatio spastica Felipathiae Gacraluia cpasticis myaspasimtus Spandwylarthrasis spandvlapathia Sv lumbosacralis cw vertebralis VAS acuta AS chronica Triger points profundus deep Trigger points superficialis Zetema articulatio sacroiliacalis 5l 19 sacroiliacal Locality 3 lumbosacral Locality 4 rear thigh LOCALISATIO 33 LOCALISATIO 4 T m 5 1 Oo Analgia Analgesia Celulitis Analgia Analgesia Decubitus Contractura Ischialgia Hypertonia musculorum Musculus abbreviatus Hypertonia musculorum Musculus scissus Ischialgia Striae Lumbalgia Musculus abbreviatus Musculus abbreviatus Myalga 00008 Myalgia Mvagelasis Myorelaxatio Osteoporosis Spasticis myospasmus Triger points profundus deep Triger points profundus deen Trigger points superficialis Trigger points superficialis User s Manual VAS 07 BETTER FUTURE edition Locality rear thigh 20 Locality 5 rear chest LOCALISATIO 5 Acne Acupuncture contactless stimulation of the needles Distensio muscularis Hynertonia musculorum Myalgia Myorelaxatio Myorelaxatio Fost poliomyelitis syndrom Spasticis myaspasmus Triger points profundus deep Trigger points superficialis Locality 7 front knee LOCALISATIO 7 Arthrosis acuta exacerbans Arthrosis chronica Anhrasis cedematosa Cantusio Coxarthrosis coxalgia Dolor p e post
3. CSN EN ISO 13 485 idt ISO 13 485 CSN EN 60 601 1 idt IEC 601 1 CSN EN 60 601 1 2 idt IEC 601 1 2 CSN EN 60 601 1 4 idt IEC 601 1 4 Governmental Order of the CR No 480 2000 Coll on health protection from non ionising radiation in accordance with the Guidelines for exposure limitation to electromagnetic field of international commission ICNIRP Act 316 2000 Coll Edict 316 2000 Coll CSN EN ISO 14 155 1 CSN EN ISO 14 155 2 idt ISO 14 155 1 ISO 14 155 2 CSN EN ISO 14971 Act 527 1990 Coll Act 478 1992 Coll Act 207 2000 Coll Act 441 2003 Coll Act 22 1997 Coll EU Notified Body 1014 EU Notified Body 1014 EU Notified Body 1014 EU Notified Body 1015 EU Notified Body 1015 EU Notified Body 1015 National reference laboratory for non ionising electromagnetic fields and radiation Clinical and evaluation workplace determined by the Health Ministry of the CR EU EU Notified Body 1015 Industrial property administration of the CR Manufacturer User s Manual VAS 07 BETTER FUTURE edition Certification testing reviewing patent or other body Body Electrotechnical Testing Institute EZU Prague Electrotechnical Testing Institute EZU Prague Electrotechnical Testing Institute EZU Prague Engineering Test Institute SZU Brno Engineering Test Institute SZU Brno Engineering Test Institute SZU Brno The National Insti
4. User s Manual VAS 07 BETTER FUTURE edition 49 You can select the procedure entered previously Procedure Selection You can enter parameters of your individually created procedure Procedure Insertion You can delete the procedure entered previously Procedure Deletion Note This menu also accesses deletion of any of the procedures saved in the Favourite Procedures folder In the following the Procedure Insertion will be described pe SS User Procedures Procedure Loading Name Entering M Z 1 z User s Manual VAS 07 BETTER FUTURE edition 50 By means of the above described procedure the name of the inserted procedure should be entered first ser Procedures Froacedure Loading Name Emnterins U Lan m F3 p 4G n Lm nox e CH T rof Sco Then using the buttons A 13 V 14 or using the cyclic procedure you can move to the item IMP pulse currents or INT interference currents and confirm the required highlighted item by plese the button 12 In this manner you can select modify all biotropic parameters of the procedure At pulse currents this regards the pulse width the first and second frequency used and time of action of the first and second used frequency within the framework of one period At interference currents this regards the frequency of base swing and spectral program spectrum Of
5. The higher energy potential of these particles would be a pre requisite for their easier interaction with protein carries ensuring via various mechanisms and the transfer of electrically charged particles via the cell membrane This theory was elaborated mainly for calcium cations Ca but on principle nothing prevents from its utilisation to other electrically charged particles passing via the cell membrane The calculated increase in energy which is in a living organism under the threshold of its thermal noise calls against this theory On the other hand also very subtle threshold and sub threshold actions may significantly influence intracellular and extracellular concentration of electrically charged particles and at the same time minor changes of these concentrations may be a significant contribution for the transfer of cell from the pathological to physiological state of its functioning The Settings folder describes technical issues of operation of the device VAS 07 BETTER FUTURE edition In this folder you can select a language for communication keyboard sounds can be switched on off the safety code can be switched on off and the item Service Mode can be called up This mode is intended for the personnel of authorised service and its use is not expected by the operating personnel of the device Nevertheless below is the brief information The items ADO and AD1 show resonance frequencies of electric current in the
6. and applicator work optimal which is important for the creation of interference electrotherapeutic currents with a rotating vector of the electromagnetic field If the applicator needs to be replaced or service actions needs to be done leading to replacement of excitation coils their positions or change in electric properties of their leads including a particular connector it is necessary to carry out its precise tuning This action is ensured automatically by the device VAS 07 BETTER FUTURE edition In the service mode press and hold the button START STOP position 10 in Fig 3 2 2 for 5 seconds as a minimum Then the 1st adjusting coil will be automatically tuned followed by the 2nd coil This tuning is performed at interval of 4 000 6 000 Hz The resonance maximum is usually found around 5 000 Hz The device memories the resonance maximum values for all adjusting coils up to possible automatic re tuning irrespective of the device switch off Note If any of the adjusting coils or their electric circuits is damaged the value of 0 Hz is set and an error is indicated in a particular note The manufactuter reserves all rights of changes without previous notice within the meaning of innovations and constructional adjustments 4 4 Cleaning and Disinfection The device device assembly should be kept clean and effectively prevented its excessive pollution of contamination If the device is not used for a longer
7. ununited fractures cy oudeck ov Tietz User s Manual VAS 07 BETTER FUTURE edition Traumas and their consequences Traumae et suae sequelae Analgia Analgesia Combustio Contractura Contusio Distensio muscularis Distortio Dolor p e pastaperativa Dolor pastextractianem stomatologia Fractura Haemarthrasis Haematoma acuta Haematama chronica Chelaidum Laesio ligamenta cruciata Laesio menisci Luxatio Musculus scissus edema acuta edema chronica steasvynthesis Pseudoarthrasis ununited fractures Sanatio pastoperativa sanatio pasttraumatica 17 Disorders of muscles and relevant nerves diagnoses indications Traumae et suae sequelae Analgia Analgesia Combustio Contractura Contusio Distensio muscularis Distortio Dolor p e postoperativa Dolor postextractionem stomatologia Fractura Haemarthrasis Haematama acuta Haematama chronica Chelaidum Laesio ligamenta cruciata Laesio menisci Luxatio Musculus scissus edema acuta edema chronica steasynthesis Pseudoarthrasis ununited fractures Sanatio pastoperativa sanatio pasttraumatica User s Manual VAS 07 BETTER FUTURE edition Entezopathy and other Enthesopathiae et alium Calcar calcanal Enthesopathiae Epicandvlitis ALIUM Ache Acupuncture cantactless stimulation of the needles Adhaesia dolorosa Achillodynia Algadystraphic syndrom lower limb Algadystraphic syndrom upper limb Alloglastica Celul
8. PERSONS User s Manual VAS 07 BETTER FUTURE edition 40 The manufacturer recommends to extent this distance as follows 0 5 metre for the operator resp 1 m for other persons from the applicator in the course of running procedure Pregnant persons and persons with electronic prostheses in their bodies must be fully ruled out from operation of the device as well as from administration of procedures Important instructions for the operating personnel Damage of the detachable mains supply cord is the most case of electric shock in all electrical mains appliances Before connecting the device to the electrical mains power supply and or switch the device on and its operation it is necessary to check carefully the integrity of the detachable mains power supply integrity of the applicator cable 11 and its connector 12 12a as well as integrity and entireness of plastic insulation encapsulation of the applicator 3 and instrument unit 2 4 2 Operation of Mechanical Parts of the Device 1 Travel with the entire device assembly firmly placed on the instrument stand 1 This travel is secured with four wheels 14 When travelling the wheels must be unbraked brake levers 14a are to be lifted On the contrary after reaching the required position the wheels 14 must be braked brake levers 14a are to be pressed When travelling the detachable mains supply connection 13 must not be at risk Therefore before tr
9. an exclusive authorised provider of service care for this device in the Czech Republic and Slovakia User s Manual VAS 07 BETTER FUTURE edition 5 2 5 Safety Instructions The device VAS 07 BETTER FUTURE edition was designed and manufactured for the safest use However its safe as well as purposeful and effective use intends on the qualified procedure prescription proper operation and necessary care and caution Improper use of this device may result in serious consequences It is necessary to observe all safety instructions and other information provided for the device VAS 07 BETTER FUTURE edition as well as information in connection with the physical and therapeutic method of distance electrotherapy i e contactless electrodeless It is also necessary to follow further development of knowledge in this area of medicine to apply therapeutic procedures by persons having relevant medical qualification and to observe all necessary legal provisions regulations and recommendations Users of this device must have available information provided by this user s manual or other information provided within the framework of training for operating personnel or in connection with other utilisation of the device VAS 07 BETTER FUTURE edition and applying the physical and therapeutic method of distance electrotherapy contactless electrodeless In using this device within the framework of health care service provision a particular
10. applicator coils Without achieving this frequency it could not be possible to ensure electrotherapy with interference currents For this reason electronics of the device VAS 07 BETTER FUTURE edition is solved in such a way to be able always and fully automatically find the optimal resonance frequency at the narrow interval around 5000 Hz namely for example with regard to ageing or after replacement of the applicator Information at items ADO and AD1 informs about the optimal resonance frequency of both applicator coils generating electromagnetic field when the coils include the required angle that is necessary for the creation of interferences in the therapeutic area before the applicator and to achieve spontaneous vector rotations of the electromagnetic field Items AD2 AD3 and AD4 specify voltages in important nodes of electric connection of the device A serviceman can immediately and without dismounting the device even remotely find the place where a defect was shown find its cause and operatively ensure its adequate repair This self diagnosis option was incorporated into the device VAS 07 BETTER FUTURE edition even though technical reliability of this device is extraordinary Items AD5 and AD6 indicate the temperature which is continually measured in two significant thermally stressed places of the device inside the intelligent instrument unit position 2 in Fig 3 1 Operation of the instrument unit in a service mo
11. contact with this device or its parts could not cause any risks to the patient or other persons coming to contact with this device e switched on and the procedure is started the operator of this device must not be closer than 15 cm from the applicator in use of pulsed currents and 25 cm in use of interference currents other persons must not be closer than 25 cm from the applicator in use of pulse currents and 50 cm in use of interference currents according to assessment of exposure situation at the electrotherapeutic device VAS 07 BETTER FUTURE edition and according to the limits stipulated in the governmental order of the Czech Republic No 480 2000 Coll on health protection against non ionizing radiation in conformity with the Regulation for limiting exposure by time varying electric magnetic and electromagnetic fields of the ICNIRP commission International Commission on Non lonizing Radiation Protection Guidelines for Limiting Exposure to Time Varying Electric Magnetic and Electromagnetic Fields in accordance with the legislation of the European Community measured by the accredited National reference laboratory for non ionizing electromagnetic fields and radiation the State Health Institution in Prague The manufacturer recommends doubling the distance from the applicator in the course of running procedure i e 0 5 metre for the operator and 1 m for other persons Pregnant women and persons using electronic prostheses must be f
12. degenerative diseases of the locomotor system such as arthrosis however the distinctive therapeutic effect should be seen during the series of max 20 procedures which corresponds to one month time period If the therapeutic effect does not appear after this time it mostly has no sense to continue in administering the procedures User s Manual VAS 07 BETTER FUTURE edition 11 Note It is the responsibility of a qualified physician to decide about the selection of pulse or interference currents for the treatment of particular diagnosis and patient From the biophysical viewpoint it can be generally declared that at interference therapeutic currents applied in the form of DE using the device VAS 07 BETTER FUTURE edition a more significant and faster therapeutic effect can be expected however associated side effects such as increased soreness during the first and several first applications may occur During application of interference currents it is also necessary to take care of relative contraindications for example heating of endoprothesis Pulse currents however can also be effective enough in many cases that they can exceed generally more radical interference currents especially if these currents are close to TENS type currents for pain relief on the basis of return theory or on the basis of endorphin production stimulation and currents close to SP type according to Professor Basset intended for support of healing an
13. instrument unit indicates the presence of electric voltage on this connector intended for power supply of the therapeutic applicator e he operating personnel must regularly check the quality and integrity of cables connector and plastic cover encapsulation of the applicator If any damage is found the device must be immediately shut down from operation and authorised service must be contacted e Persons operating the device VAS 07 BETTER FUTURE edition are obliged to avoid influences of electromagnetic fields to the maximum possible extend e The applicator is to be applied to the treated part of the patient s body when the procedure is not running and the start of the procedure is to be done subsequently from the instrument unit located on the opposite side of the instrument stand than the applicator At the time of starting the device the operating personnel standing in front of the control panel of the instrument unit is at a sufficient distance from the applicator applied in the vicinity of the patient s body e From the viewpoint of preliminary caution pregnant persons and persons with electronic prostheses such as pacemaker are not allowed to advance towards or stay in the influence area of the developing electromagnetic field of the applicator Similarly from the viewpoint of preliminary caution these persons are not allowed to operate the device or to be treated with this device User s Manual VAS 07 BETTER FU
14. is damaged CAUTION switched on and the procedure is started the operator of this device must not be closer than 15 cm from the applicator in use of pulsed currents and 25 cm in use of interference currents other persons must not be closer than 25 cm from the applicator in use of pulse currents and 50 cm in use of interference currents according to assessment of exposure situation at the electrotherapeutic device VAS 07 BETTER FUTURE edition and according to the limits stipulated in the governmental order of the Czech Republic No 480 2000 Coll on health protection against non ionizing radiation in conformity with the Regulation for limiting exposure by time varying electric magnetic and electromagnetic fields of the ICNIRP commission International Commission on Non lonizing Radiation Protection Guidelines for Limiting Exposure to Time Varying Electric Magnetic and Electromagnetic Fields in accordance with the legislation of the European Community measured by the accredited National reference laboratory for non ionizing electromagnetic fields and radiation State Health Institution in Prague According to the viewpoint of the international commission ICNIRP and Governmental Order of the Czech Republic No 480 2000 Coll in conformity with the requirements of the European Union in applying the DET procedure it is necessary to meet the following distance from the applicator Operating mode of the device OPERATOR OTHER
15. localities will paper in the display The localities are marked with numbers from 1 to 21 which correspond to a particular illustration display of locality in the figures printed on the front panel of the instrument unit At the same time the locality is described in words in the display 8 as shown in the below table l Locality description Locality number l International nomenclature English names User s Manual VAS 07 BETTER FUTURE edition 48 IM Foot region foot distally EWS Particular localities in the display 8 can be selected by the buttons A 13 V 14 and confirmed by pressing the button 12 After selection of a required locality all diagnoses which would have any relations with a particular locality will appear in the display Of them using the normal manner you can select the required diagnosis and after its confirmation the display will show one to three electrotherapeutic pulse currents and one to three interference electrotherapeutic currents in the tabular form basically identical with Fig 4 3 5 Other procedure is analogical to the previous one If you do not want to use the pre programmed Standard Procedures but you want to set your own pulse or interference electrotherapeutic currents with your parameters then select User Procedures in the Basic Menu After confirmation of this selection by pressing the button 12 other options will appear in the display 8
16. must be slightly released This release must not be complete but only to allow the movement of the applicator 3 on the spherical head 5 by the use of adequate force so that the applicator 3 remains independently on the spherical head 5 in a resting state without its falling This state can be achieved by adequate tightening releasing the fixation lever 6 on the spherical head 7 The applicator can be tilted by 90 from horizontal to vertical position in two diagonal positions on the spherical head This position can be easily found by turning the applicator 3 around its vertical axis Other operation of the device is performed from the instrument unit 2 User s Manual VAS 07 BETTER FUTURE edition 41 4 3 Operation of the Instrument Unit of the Device VAS 07 BETTER FUTURE Edition The instrument unit and device VAS 07 BETTER FUTURE edition is to be switched on using the rocker switch button position 6 in Fig 3 2 1 located at the rear part of the instrument unit in the vicinity of the mains supply plug connector position 5 in Fig 3 2 1 The switch is switched on in position l and switched off in position O The graphical display position 8 in Fig 3 2 2 on the slant front panel of the instrument unit will light up Note If this does not occur the most frequently this means power failure omission to connect the instrument unit to power supply by means of mains cord damage of the m
17. other countries see the list of the authorised distributors and services 2 3 Purpose of the User s Manual The purpose of this manual is to provide users of this device and relevant responsible organisations with the necessary information needed for its handling and safe operation If the user or the person responsible does not understand nor has any doubts he she must immediately contact the manufacturer or the authorised distributor This manual is intended for all users of the device and responsible organisations which use this medical device in any manner they prescribe administration of therapeutic procedures by means of this device recommend this device to therapeutic preventive or reconditioning use apply therapeutic procedures operate this device or supervise the use of this device and are responsible for operation of this device This user s manual must be part of every device and available to all persons working with the specified device in any way 2 4 Guarantees In accordance with the legal provisions in force and unless otherwise stipulated in a purchase contract the guarantee period for the device VAS 07 BETTER FUTURE edition is 24 months as from the date of its sale In the event of warranty claims the properly completed guarantee certificate must be submitted The guarantee period shall be extended by the time for which the device was repaired in the guarantee time The guarantee cannot be accepted if the de
18. points to the opposite side of the stand 1 than the instrument unit 2 Tighten firmly the tightening handle 9 Subsequently release again slightly the fixation element 5 of the spherical head 6 at the rear part of the applicator 3 Then you can set the applicator in such a way that its emitting area of User s Manual VAS 07 BETTER FUTURE edition 39 black colour points in the horizontal direction opposite to the instrument unit Tighten naturally the fixation element 5 so that the applicator can be freely moved only with putting adequate but higher force This is the basic arrangement of the device before further operation Important instructions for the operating personnel The operating personnel p en 9 patient and other persons may i be only at a limited area during the normal use of the device starting the procedure Fig 4 1 The applicator 3 is an applied part type BF Patient i Do not use higher angle of the Pu swivelling arm of the applicator 4 then specified in Fig 4 1 Limitation of area for the the figure patient and operating personnel The device must not be placed in such a way that its disconnection from the electrical mains by withdrawal of the plug from the socket is difficult The device must not be located in such a ways that its detachable mains inlet could be easily withdrawn from the mains socket outlet or appliance inlet 13a or the mains supply cord
19. procedure must be prescribed by a qualified health care professional and the operating personnel of this device must also be medically qualified and appropriately trained for operation of this device The device must not be used to other purposes than the intended purposes of use inan external environment inan environment with the increased risk of electric shock for example humid or wet environments or environment with moving and unsecured mechanical substances inan explosive environment In an environment with the high risk of fire if exposed to adverse weather conditions in inadmissible technical adjustments in noncompliant conditions of electric power supply in absence of a fully responsible user proper prescription of therapeutic procedure s and or qualified and trained operating personnel ina situation when the patient client or his justified interests or operating personnel and third persons might be threatened by this device or by the administered therapeutic procedure or when any other detriment might be caused Special warnings e When prescribing and applying procedures it is necessary to respect thoroughly all contraindications risks and possible side effects and always assess individual and actual patient s conditions as well as other factors e he patient s body parts coming to contact with this device must be fully intact or must be treated or covered in such a way that
20. safer program and to prolong the interval between procedure administrations In extreme cases the treatment should be discontinued At acute painful situations for example injuries acute inflammation and the like the reactive phase usually does not occur and application of a suitable DE program is usually able to mitigate pain gradually This response however can occur after a variously long time sometimes significantly exceeding the usual time of procedure In these cases DE can be applied for a duration of 1 to 2 hours User s Manual VAS 07 BETTER FUTURE edition 32 3 Technical Description of the Device 3 1 Description of the Device Assembly The device VAS 07 BETTER FUTURE edition consists of a travelling stand 1 with a fixedly placed own intelligent device unit 2 and a movable placed applicator 3 The applicator 3 is fixed to a swivelling arm of the applicator 4 by means of a spherical head 5 Force holding the applicator on the spherical head is adjustable by a manual tightening element 6 used for firm fixation of the applicator in a required place If however this tightening element 6 is tightened only adequately the applicator can be moved on the spherical head by certain force to the extent enabled by the spherical head Then the applicator stays in a required position where it can be fully fixed by tightening the tightening element 6 and to prevent in this way its undesirable moveme
21. sudden chan ges The relative humidity max 75 User s Manual VAS 07 BETTER FUTURE edition 59 4 9 Transport Shipping cases with devices can be transported by common covered means of transportation without heavy shocks The device packaged in a shipping case must be handled with care similarly as with fragile shipment side up do not exceed the permissible storage conditions 4 10 Environmental Conditions Under Operation of the Device VAS 07 BETTER FUTURE Edition The device is intended for use in normal safe areas in which the use of electrical equipment is common and safe if this electrical equipment and their use comply with the related provisions i e internal environments inside buildings dry free of dust without the risk of fire explosion without flammable gases and vapours and the like User s Manual VAS 07 BETTER FUTURE edition 60 5 Certification Subject CE 1014 Quality control system of manufacturer Electrical and functional safety Electromagnetic compatibility EMC Programmable electronic medical systems Measurement of electromagnetic field and induction of electric current Clinical trials Risk analysis Industrial and legal protection Declaration of conformity Regulation statutory requirement directive order recommendation Council Directive EU 93 42 EEC Government Order of the CR 336 2004 Coll Council Directive EU 93 42 EEC
22. the subject authorised to do so by the manufacturer This subject must be qualified trained and equipped with properly calibrated measuring equipment e After proper education the patient client may be left under the remote supervision of a qualified medical operating personnel during the procedure only under the condition that his her health condition and physical and mental capacities enable this If these conditions are not fulfilled in a reliable way the patient client must be under the permanent supervision of a qualified health care professional during the procedure and shortly after its finishing if for example the risk of collapse condition exists due to blood pressure reduction or neurovegetativelly at psychically labile individuals e he device VAS 07 BETTER FUTURE edition is a medical device which must not be operated without the supervision of a responsible and qualified health care professional This person must be able to assess and correctly and reliably interpret anamnestic and diagnostic points leading to effective purposeful and safe application of DE procedure contactless electrodeless In doing so this responsible person must also consider all other diagnostic results regarding a particular patient client patient s client s personality and all potential risks It also must take into consideration the viewpoint of preliminary caution as well as the current knowledge of medical science and research t
23. 07 BETTER FUTURE edition Locality 18 leg distally LOCALISATIO 18 Algodystrophic syndrom lower limb Arthritis rheumatica Arthritis urtica Arthrasis acuta exacerbans Arthrasis chronica Arthrosis oedematosa Atherosclerosis ischaemia peripherica Fractura M B rger Mikroangiopathia Meuroapathia Paraesthesia Dysaesthesia Paresis neni musc Paresthesia acralis Reqeneratio nervi periferi Vasoneurosis universalis Locality leg distally 26 Locality 19 calf Locality 20 ankle LOCALISATIO 19 LocALISATIo 20 O 3 O zi Alloplastica straphic 5 naram lower limb Cicatrix chelaidea Alloplastica Cicatrix chronica Atherosclerosis ischaemia peripherica Cicatrix recens Claudicatio intermitens Contusin Contusia Decubitus Decubitus Fractura Haernatama acuta Haemiatoma acuta Haematoma chronica Haematoma chronica Lymphoedema Hypatania musculorum M B rger Cheloidum Osteonathia Mikroangiopathia Wleus cruris Myopathia Masoneurasis universalis Meurapathia Feriostitis Pseudoarthrosis ununited fractures Reneneratio cutaneus sensibilitas Regeneratio nervi periferi Sanatio postoperativa Sanatin posttraumatica Spasticis myaspasmus Tanisatia musculorum User s Manual VAS 07 BETTER FUTURE edition Locality ankle 27 Locality 21 crura LOCALISATIO 21 Locality crura Acupuncture contactless stimulation of the needles Algadystrophi
24. BETTER FUTURE edition is a medical device whose safety and functionality can be assessed only by the manufacturer or by qualified and adequately equipped person authorised by the manufacturer it is the duty of a responsible institution utilising the device to ensure its regular inspection regular functional and safety checks The manufacturer recommends performing these checks once per year A check report must be made about the check performed and the responsible institution health facility physician or User s Manual VAS 07 BETTER FUTURE edition 58 physiotherapeutist meets in this way the requirements of EU legislation regarding medical devices In the course of periodic inspection regular functional and safety checks the authorised service performs prescribed maintenance actions of electric medical devices as well as measurement of therapeutic induced electric currents 4 6 Environmental Protection and Disposal of the Device The device VAS 07 BETTER FUTURE edition does not have any direct negative impact on the living environment From the viewpoint of requirements for protection before non ionising electromagnetic radiation it is only necessary to ensure that the operating personnel and other persons meet the prescribed protective distances from the running applicator The device under operation has a small power take off max 25 VA After the elapse of its life time and putting the device out of operat
25. DE can be effectively used in treatment of trophic disorders in particular venous ulcers mainly postphlebic arterial and diabetic Nevertheless the favourable effect has been reported also in treatment of varicose ulcers and mixed ulcers In addition DE can be used to support regeneration of damaged axons of peripheral nerves innervating skeletal muscles at muscular asthenopia in treatment of cutaneous sensation disorders at anaesthesia and some types of peripheral pareses in treatment of vasoneuroses and various neuropathies and polyneuropathies especially diabetic ones Procedures of DE can also be applied in supportive treatment of osteoporoses mainly in problem parts of skeleton neck of femur area of Colles fractures on the radius and ulna threatened vertebral bodies area of the LS spine and hips in supportive treatment of aseptic bone necroses and as support in healing of fractures DE can also be used in supportive therapy of some diseases of skin tissues in particular already mentioned thropic changes regeneration of damaged skin surface inflammatory and cicatricial complications of acne some constitutional dermatitis lichen simplex and the like and in dermatic and cosmetic applications striae weak skin cellulitis DE can also be used outside the area of locomotor system therapy in cases when use of electric therapeutic currents and associated electromagnetic fields is generally known and it is beneficial fo
26. Fig 3 2 3 Connection of the applicator to the device The encapsulated applicator 3 has an ergonomic shape Its Z front area see the Figure 6 gt 2 which is to be applied to the AEP ERATOR treated body part is provided with a matrixof6x4o0or8x5 16 according to type LED diodes i emitting the red colour of wave length of 660 nm The LED diodes with protective resistors e FOR PHOTOTHERAPY are connected to the auxiliary PCB located inside the applicator case Fig 3 2 4 Front application area of the therapeutic applicator version with 24 LED diodes Important instructions for the operating personnel It is not admissible to expose the persons or animals to LED lights for a long time or from a close distance User s Manual VAS 07 BETTER FUTURE edition 37 3 3 Legend Description on the Device Device for Distance Electrotherapy VAS 07 Better Future edition C E 1014 Manulactured in Czech Republic EMBITRON s r o Certified by ISO 13 485 2003 Classification llain accordance with EU Council Directive 93 42 EEC standard IEC 60 601 1 supply voltage 230V 7 input 25 W Insulation class ll type BF Degree of protection IP 30 Year of manufacture oN lt lt APPLICATOR P gt 230 V 60 Hz Devicename _ 08 07 jJ BETTER FUTURE edion Manufacturers name EMBITRONsrO Jo o o Manufacturer s certifica
27. LJedema acuta Jedema chronica Tendinitis acuta Tendinitis chranica Tendopathia Tendovaginitis acuta Tendovaginitis chronica Locality side knee 22 Locality 11 arm LOCALISATIO 11 Locality arm Acrocyanosis Acroparaesthesia acrodysaesthesia Acupuncture contactless stimulation of the needles Algodystraphic syndram upper limb Arthritis rheumatica Arthrosis acuta exacerbans Arthrosis chronica Arthrasis oedematasa Combustio uputren s contractura Eczema Fractura M Raynaud Mikraangiapathia Paraesthesia Dysaesthesia Paresthesia acralis Regeneration nervi periferi Sy Sudeck Vasaneurasis universalis User s Manual VAS 07 BETTER FUTURE edition Locality 12 wrist LOCALISATIO 12 Algodystrophic syndrom upper limb Distartio Luxatio QGedema acuta Oedema chronica Osteoporosis Paresis nervi must Fegeneratio neri periferi Sanatio postaperativa Sy canali carpi Sy Sudeck Tendinitis acuta Tendinitis chranica Tendopathia Tendovaginitis acuta Tendovaginitis chronica Locality wrist 23 Locality 13 forearm Locality 14 elbow LOCALISATIO 13 LocAuisario 14 Locality forearm Algoaystrophic syndrom upper fimb Fractura 7 Allaplastica Lymphoedema Contusio Paresis neri musc Decubitus Fegeneratin nervi periferi Distartia Sv Sudeck Eczema Ten dinitis acuta Enthesanathia p Tendinitis chronica Epicandylitis lendopathia _ Haemiarthrosis ESCA UI
28. PA 11 RILSAN Luminous flux produced by the applicator User s Manual VAS 07 BETTER FUTURE edition 10 2 7 Indications and Contraindications of Distance Electrotherapy Electrodeless Contactless 2 7 1 Indications and Administration of Distance Electrotherapy Procedures Distance electrotherapy is intended mainly for supportive physical therapy in treatment of all algic painful acute conditions of the locomotor system in particular traumatic and or inflammatory nature as well as chronic conditions usually degenerative In degenerative diseases of the locomotor system distance therapy is used with the aim of pain relief and support of regeneration or repair of tissues in particular in the events of arthroses chondromalacies entezopathies vertebrogenous algic syndromes and the like In treatment of fresh and older posttraumatic conditions distance electrotherapy is used with the aim of pain relief and support of healing in the events of distortions contusions posttraumatic oedemas haematomas hemarthroses fractures ununited fractures to support healing of ligaments tendons and damaged articular capsules in treatment of consequences of injuries and Surgical operations in treatment of algodystrophic syndromes and the like DE can also be used as supportive treatment of peripheral capillary return disorders of various aetiology especially micro angiopathies and functional disorders of peripheral capillary return
29. TURE edition 9 2 6 Technical Characteristics of the Device VAS 07 BETTER FUTURE Edition MR Medical device of Class ll a Health classification in accordance with the Council Directive 93 42 EEC Device supplied from the external power supply source AC power supply network 230 V 50 Hz Electrotechnical classification or 115 V 60 Hz if so modified by the manufacturer From the viewpoint of protection against electric shock the device of Class Il Electrotechnical standard used CSN EN 60 601 1 IEC 601 1 Classification of application part of the BF according to Czech standard CSN EN 60 601 1 equivalent to electric medical device ICE 601 1 Classification from the viewpoint of protection against ingress of water or IP 40 according to IEC 60 529 solid parts Classification for operation permanent in areas internal normal areas without increased risk Sterilization This device is not to be sterilized 230 V 50 Hz alternating sinusoidal Power supply voltage or if so modified by the manufacturer 115 V 60 Hz alternating sinusoidal Power required 25VA Protection of electrical power supply doe mA time lag fuse T located inside the instrument Magnetic induction produced by the Interference currents peak value at one polarity 1 mT applicator Pulse currents peak peak value of pulses 2 mT Intensity of induced electric voltage and Interference currents peak value at one polari
30. USER S MANUAL VAS 07 CONSTRUCTIONAL AND DESIGN MODIFICATION BETTER FUTURE edition User s Manual VAS 07 BETTER FUTURE edition TABLE OF CONTENTS Intended Use and Basic Description of the Device 3 General 5 00 5 Authorised Distributor and Service ccccccsseccecceeeceeceeeceeceeseeceeeeceeceueeeessaeeessuaeceeseeeeesaaes 5 Purpose of the User s Manual ssssesssssssseeeeeeeenene nennen nennen nnns nnne nnns 5 0 5 TOS oie are cite a a ee eae eee clase ee erases 6 Technical Characteristics of the Device VAS 07 BETTER FUTURE Edition 10 Indications and Contraindications of Distance Electrotherapy cccecceeeeeeeeeeeeeeeeeeeeeeees Electrodeless Contactless ccccccccsssseceecceeeseceecceeeseceeeeeesseceeeseeaeeeeessuaaeeeeesseageeeeesaeaess 11 Indications and Administration of Distance Electrotherapy Procedures 11 Classification According to Indication Groups cccccceeeeeeeeeaeeeeeeeeeeaeeeeeeeeeaaeeeeeesaeeseeeees 15 Classification According to Treated Localities sese 19 Contraindications Risks and Side Effects of Distance Electrotherapy 29 COMM CIC AU OWNS pathos ems 29 RISKS 0 000 31 sect st a te eter ee eae eee een ee 31 Technical Descrip
31. able User Procedure Procedure Sel AHMED Important information Stochastic randomised currents Within the framework of the User Procedures folder it is possible to create individual pulse electrotherapeutic currents whose frequency is randomly changed at interval from the lowest frequency of 1 Hz up to the maximum frequency which is optionally selected up to 999 Hz These electrotherapeutic pulse currents are usually referred to as stochastic or randomised User s Manual VAS 07 BETTER FUTURE edition 53 These currents are selected by setting the item Frequency 1 User Procedures Procedure Insertion Procedure Name Pulse currents IMP Frequency 1 After marking the Frequency 1 position press the button 12 Then press and hold the button A 13 to achieve and exceed the data 1 200 Hz the maximum possible adjustable frequency of individual pulses After exceeding this value and after holding the button A 13 pressed the value R001 to R999 will be offered This value represents an optional upper limit of frequency interval of stochastic currents This value can be precisely searched by using the buttons A 13 V 14 The letter R before the number specifying the upper interval limit of randomised stochastic randomised frequencies represents the randomised state the fact that all frequencies from a selected interval will be given to the patient fully randomly with a same probab
32. ains cord or failure of the protective mains fuse Failure of this protective cut out fuse is very unlike This fuse is located inside the instrument unit and its replacement along with finding the cause of its failure and subsequent actions must be exclusively made by the authorised service On the graphical display the Basic Menu window will appear ar E TILZEN Procedure gt Procedures al Procedures DD ot C OT OS T e Coir mm 3s By means of buttons A 13 V 14 the required position can be searched in the up down direction or cyclically The selection is identified with a highlighted bar using the inversion colour of fonts blue in a white bar The selection is confirmed by pressing the button 12 If the item Standard Procedures is selected in this manner the following menu will appear Standard Procedures Indication Group Troubleshooting User s Manual VAS 07 BETTER FUTURE edition 42 A decision can be made between the next selection of a therapeutic program according to indication groups or according to localisation of patient s problems Select and confirm the indication Group item The following menu will appear Ht I idard Procedures idication Grout T i LET LE ITI Doe gt cel 2 E fn T Morbi IOPFDI Morbi Morbi Morbi Traumae Morbi mu EnthesoPa gt iu pt m l D Die
33. any damage or signs of wear and tear the device must be immediately disconnected from the mains and a new mains inlet must be provided from the manufacturer or authorised service The operating personnel must connect a detachable mains inlet mains cord in such a way to prevent its damage or withdrawal from the mains socket outlet or appliance inlet of the device As well as any signs of damage of the appliance inlet 5 and power switch 6 must be a reason for immediate disconnection of the device from the power supply and call of the authorised service User s Manual VAS 07 BETTER FUTURE edition 34 The front tilted panel of the device 9 10 consists of graphic display 8 and six control buttons the MENU button 9 to call the basic menu of the device the START STOP button 10 to start stop the button C 11 to return to the state of previous selection or in some cases to prepare the termination of procedure the button 12 to confirm selections shown on the graphic display the button A 13 to increase parameter values or to move in the display upwards or right the button V 14 to decrease parameter values or to move in the display downwards or 1 left 11 13 14 12 ET Functions of individual buttons are 1 8 F uir jin i nd of described in more detail in the mm LUN e instrument uni instructions for use of the i
34. apeutic procedures and control algorithms The microprocessor is also the centre of self diagnosis and self repair of the device These advanced technical functions rank the device VAS 07 BETTER FUTURE edition among the world unique electronic medical devices This results in extraordinary high reliability of the device for the user a negligible risk of defects and ability of the device to adjust its technical parameters automatically and intelligently in such a way that the medical parameters are always optimal under each situation For example the microprocessor checks and automatically sets resonance frequencies of both coils in the applicator which is the necessary condition for creation of interference currents In addition the microprocessor checks the temperature in several important places inside the instrument unit case therefore overheating of any part of the device cannot occur even extremely energetically demanding combinations of biotropic parameters are selected because the microprocessor automatically reduces the duty cycle in such cases The microprocessor also monitors and automatically adjusts several internal electric voltages important from the viewpoint of long term stability of biotropic parameters and stability of the entire device User s Manual VAS 07 BETTER FUTURE edition 35 The microprocessor accepts instructions entered by the operating personnel by means of six button located on the front panel of th
35. avelling when an undesirable movement of the detachable mains inlet can occur it is necessary to switch off the instrument unit first using the switch number and then disconnect the mains plug from the mains socket outlet Setting the applicator 3 position as an applied part of the device 2 1 Applicator vertical setting This setting is secured with a vertical travel shift using spherical bushes 7 upwards or downwards the guide bar 8 Before this shift it is necessary to grasp the applicator arm 4 or the applicator 3 and release the tightening handle 9 on the travel body 7 Upon reaching the required position retighten the tightening handle 9 firmly 2 2 Swivelling setting the applicator arm Again this positioning is secured by means of travel with spherical bushes 7 on the vertical guide bar 8 CAUTION Do not exceed the maximum allowed angle according to Fig 4 1 2 3 Applicator positioning on the spherical head This positioning allows applying the front area of the applicator very precisely to a point being treated By means of the spherical head the applicator may be tilted in such a way that its front area points downwards vertically This position is used mainly in treatment of a patient laying on bed or couchette while the horizontally directing front area of the applicator is used mainly in treatment of a sitting patient Before positioning the applicator on the spherical head 5 its fixation lever
36. c electrostimulation currents should selectively support the development of beta endorphins serotonin and the like to stimulate production of endogenous opiates to harmonise the vegetative nervous system to assist in substance transport during metabolism and tissue detoxication to stimulate selectively thin nervous tissues or on the contrary to stimulate selectively thick nervous tissues Special Procedures Information Therapy Transcutane Nerve Stimul Hdoetene oPlates ved harm Leeson and detoxification abs fibres herve fTibr sserotonine User s Manual VAS 07 BETTER FUTURE edition 55 In the selection of any procedure physical parameters of this procedure are exactly known and displayed in the display 8 The Information Therapy folder also contains special procedures providing electrostimulation currents with frequencies according to Dr Nogier Dr Bahr Dr Claus Dr Reininger and frequencies which should show affinity to hypothetic routes of the human body often with identical important vegetative knitting The maximum applied frequency is limited up to 3 123 Hz The Cyclotron Resonance folder contains the offer of electromagnetic signals of highly specific quasiharmonic frequencies which would on the principle of cyclotron resonance in the environment of acting magnetic field of the earth evoke acceleration of electrically charged particles in the human organism and increase of their energy
37. ce assembly is to be only removed out of the shipping case If you have the device assembly which is not pre assembled it is necessary to screw the stand legs 1 and wheels 14 Before the removal of the device assembly from the case it is necessary to remove a protective insert first or to place the shipping case in such a way that the device assembly could be carefully pushed out without damaging the assembly and or shipping case It is also necessary to check whether all device parts are removed from the case such as accompanying user s documentation User s Manual detachable mains supply mains cord in Fig 3 1 position 13 in Fig 3 2 1 position 2 or shipping documents and other materials according to agreement with the client Remove the protective packaging of the device Place the device assembly on the wheels 14 in a stable manner unbrake the wheels by lifting particular levers at the travel wheels and locate the device assembly to the required place of use Note If the device stand 1 was fixed by means of a transport board strengthening the shipping case remove both these boaras The applicator cable position 11 in Fig 3 1 is usually connected via a particular connector 12 to the instrument unit case 2 which is firmly screwed to the device stand 1 If this is not the case the plug connector 12 must be inserted into the appliance inlet 12a at the rear side of the instrument unit 2 and con
38. course itis also possible to program available parameters procedure time intensity of applied electric stimuli and work period duty cycle TUNG 1957 IEE 1 Impulse 2 Fre9uencu 2 Time 2 Current Fer Tine 7 DEM i bh b 0 1 ia i 53 CG Dex Ds Des Dex Dew Die Des Ln Procedure Time Intensity Current Period To finish Press JUNG 1957 ImPulse Frequency Time Impulse ime z Current Per Time m T CA e CIO SS cw Law cw Fac Lew 4 i e Men Procedure Time Intensity Current Period ie finish Pres User s Manual VAS 07 BETTER FUTURE edition 51 JUNG i957 eL 4 TIT s Period 0 finish Press 5 2 E Ux JUNG 1957 Impulse 1 Freduency 1 Time 1 ImPulse 2 Freduencyu 2 Time 2 l Current Fer Time Egi E HEG Time Intens LURERI Period To finish Ims Once the parameters have been selected complete the preparation of an individual user procedure by confirming the item End with Saving JUNG 1957 I THEE T Freud 6 Tine 1146 E Z 606068 g Tine r Current Fe User s Manual VAS 07 BETTER FUTURE edition 52 If you select Procedure Selection in the User Procedures folder User Procedures Procedure Procedure Favourite the previously created and inserted procedure will be avail
39. d neovaskularisation and the like In order to make easier prescription and administration of DE procedure all pre programmed procedures are summarised in the following list of diagnoses and or indications see Table 2 7 1 1 Note Some of the specified diagnoses and or indications may overlap somewhat Some of the diagnoses and or indications are identical even though they have various names In this manner searching of a required diagnosis and or indication is facilitated for various users utilising a different terminology User s Manual VAS 07 BETTER FUTURE edition 12 Table 2 7 1 1 cng PT Acrocyanosig 8 Aeroparaesthesia acrodysaesthesia Acupuncture contactless stimulation of the needles Adhaesiodolorosa Adhaesio dolorosa AIC nm Achillodynia Achillodynia Algodystrophic syndrom lower limb o 9 Aloplstie O Atherosclerosis ischaemia peripherica 60 y MPeths O 66 Musculus seissus User s Manual VAS 07 BETTER FUTURE edition 13 088 1 Myogeoss O pF Myopic 80 JOedemachonia o o 1 86 Ostecyntheis 89 0870888 neri facialis 90 Paresthesiaacis O 96 Pseudoarthrosis ununitedfractures Z O Z o Z o 9B Regeneratio nervi periferi 99 Sarit Triger points profundus deep All th
40. de The Service Mode is selected from item Setting In the graphical display the table with four columns and seven lines will appear The columns show this Automatically measured Quantity value in a binary Quantity value in common units and controlled quantity code inside the device of measurement Hz V C User s Manual VAS 07 BETTER FUTURE edition 56 The lines show this r3 Resonance frequency of the 1 excitation coil Hz oe Dm MM EN Excitation voltage in electrotherapy circuits its size 10 12V depends on the adjusted intensity of current l Power qund voltage for sensitive electronics of the evice micro processor display and phototherapy 5 6 5 7 V with LED diodes D6 Temperature of switching transistors of pulse max 80 electrotherapy circuits Temperature of electrotherapy source utilisation for AD6 introduction of a feedback to limit duty cycle or to Max 115 130 C ensure protective device switch off All the data specified are intended for the personnel of authorised service These data are also accessible for the operating personnel who can utilise them for orientation to specify possible defects remotely for example by phone to personnel of authorised service or to check the device condition For practice use the values of resonance frequencies ADO and AD1 are important These frequencies are tuned by the manufacturer in such a way that the instrument unit
41. dures are contraindicated generally In these highly labile patients it is not admissible to use the action of phototherapy with flashlights Fresh thrombosis Menstruation This is a local and time limited contraindication The risk of DE administration consists only in the possibility of slightly increased menorrhea User s Manual VAS 07 BETTER FUTURE edition 30 Relative contraindications some objective findings bear witness of relative contraindications but not uniquely because other objective findings bring contrary results It is difficult to come to a conclusion if this regards the objective contraindication or contraindication from the viewpoint of preliminary caution or if this regards a contraindication at all if necessary caution is to be maintained at a particular patient Therefore it is the final decision of a physician whether DE is to be applied in particular cases or not the physician who prescribes a particular procedure and in co operation with a medical operating personnel who check the patient Application of DE on the area of the head other big nerve knots gonads carotid sinus heart endocrine glands and other vital organs which would be sensitive to effects of electromagnetic fields and induced electric current Application on developing tissues in children and juvenile persons On the contrary the benefit is reported in treatment of aseptic bony necroses morbus Perthes in children Applica
42. e na IS m CT Cede ie C CCS Pe C Cn s 1598 Lacon Enos Pa Current Fer User s Manual VAS 07 BETTER FUTURE edition 45 Only three parameters in the lower part of the table can be modified If no modification of these parameters is intended and their usual automatically preset values are used you can start a therapeutic procedure right away To the contrary the procedure time can be shortened or prolonged the intensity of applied current can be reduced or increased and the work period of current can by changed i e the duty work cycle which specifies the percent proportion of pre selected interval of 30 s will be really produced and pause will be created in the remaining 30 second period of procedure administration Note For example a 5096 current period means that the therapeutic current will be produced for 15 seconds and next 15 seconds will not be produced Of course in this manner introduced pause reduces the actual time of application of electrotherapeutic current during the procedure but on the other hand it eliminates an undesirable effect of reduced efficiency of electrotherapy by creating adaptation of treated tissues to its action In this manner the effect of electrotherapy can be increased At the same time introduction of a current period duty cycle lower than 10096 reduces the current load of some tissues the risk of possible temperature rise
43. e device and communicates with a graphical display located directly on the board The foil type keyboard is connected with the PCB inside the instrument unit with a cable provided with connectors For cases of software upgrade of the device a programming connector is located in the vicinity of the microprocessor The microprocessor memory is backed up with a separate battery On the PCB there is created precise and stabilised power supply for the microprocessor as well as separate power supply for therapy coils The level of this power supply is controlled by the microprocessor by means of D A converters according to a particular program or requirements There are two electrical circuits for electrotherapy for pulse therapeutic currents and for interference therapeutic electric currents For pulse electrotherapy an exciter of parallel connected applicator coils is created complemented by patented circuits of time constant regulation circuits of inductivity discharge and circuits of energy liquidation acceleration from the coils at higher pulse frequencies By these routes we can achieve the production of optimum pulses of electrotherapeutic currents while suppressing the undesirable direct current element For interference electrotherapy there are created two separate generators which produce required frequencies of around 5000 Hz with harmonic sinus courses After amplification these currents excite separately the applicator coils bu
44. e distance from the applicator is 25 cm for pulse currents and 50 cm for interference currents This distance is by the decision of the manufacturer doubled i e 0 5 m for pulse currents and 1 m for interference currents introduced safety coefficient 2 Of course with regard to the severity of foetus development and from the viewpoint of maximum preliminary caution in the event of pregnancy the manufacturer recommends to consider pregnancy as global contraindication i e regarding the whole body of a pregnant women CAUTION In women in the fertile period it is recommended to apply DE procedures always only in the period of the 1st half of menstruation cycle up to ovulation when exclusion of pregnancy is highly probable User s Manual VAS 07 BETTER FUTURE edition 29 Absolute Contraindications from the Viewpoint of Preliminary Caution Oncological diseases and serious precancerous conditions In the majority of cases when it is possible to determine a localised place of disease this is a local contraindication In a sufficient distance from the determined place DE procedures can be administered The officially determined distance is 25 cm from the applicator for pulse currents and 50 cm from the applicator for interference currents The manufacturer recommends doubling this distance i e up to 50 cm from the applicator for pulse currents and up to 1 metre from the applicator for interference currents severe ischemic diseas
45. e specified diagnoses and indications are included in the Standard Procedures folder where they are classified either according to indication groups or selected localities of the body User s Manual VAS 07 BETTER FUTURE edition 2 7 1 1 Classification According to Indication Groups Vertebrogenous diseases Morbi vertebrogenae Analgia Analgesia Contractura Degeneratio spinalis orsalqia Hypertonia musculorum Ischialgia Lumbalgia M Bechterew Musculus abbreviatus Mvalqia Mvagelasis Mvarelaxatin steochondrosis Pelvipathiae Sacralqia Spasticis myaspasmus Spondwylarthritis ancylapoetica Spandvlarthrasis spandylapathia w cervicalis cervicabrachialis cervicacranialis accipitalis lumbasacralis Tietz vertebralis AS acuta vertebralis AS chronica Tension headache Tarticallis Triger points profundus deer Trigger points superticialis fetema articulatio sacrailiacalis Sl por cen User s Manual VAS 07 BETTER FUTURE edition Degenerative diseases Morbi degenerationae Allaplastica Analgia Analgesia Athrasis acuta exacerbans Athrasis chronica Arthrasis aedematasa Loxarthrosis coxalgia Dorsalgia Gonarthrosis gonalgia Chondropathia patelae Ml Bechterew Mletatarsalgia Myorelaxatio marthrasis amalgia steachondrasis Feriarthritis humerascapularis cpandylarthritis ancylapaetica cpandvylarthrosis soondylopathia ov ve
46. e syndrom lower limb Claudicatio intermitens Lvmphaedema M B rger M Osgood Schaltter Musculus abbreviatus Musculus scissus Myalgia Myagelosis Myopathia Myorelaxatio Neuralgia Meuropathia Paresis neni muse Post poliomyelitis syndrom Fegeneratio nervi periferi For each diagnosis or indication there are 1 to 3 therapeutic pulse electric currents available and 1 to 3 therapeutic interference electric currents 341 pulse and 319 interference electrotherapeutic currents in total User s Manual VAS 07 BETTER FUTURE edition 28 2 2 Contraindications Risks and Side Effects of Distance Electrotherapy By its pulse and interference currents DE is a demonstrably effective form of electrotherapy As every really effective therapy it also has some contraindications risks and possible side effects Knowledge about them is developing for example new contraindications may paper or on the contrary some current contraindications may be shown as unreasonable It is the natural duty of the user of this device and responsible organisation to follow the development of this knowledge throughout the service life and use of the device 2 7 2 1 Contraindications Note Contraindications are divided to absolute relative global regarding the whole body and local regarding only a certain part of the body According to another point of view contraindications can be divided to objectively documented objective and o
47. echnical progress medical legislation and medical ethics The patient client must be monitored in the course of procedure administration and after them and based on the patient s reaction to DE procedures if necessary the original therapeutic decision must be re assessed for example within the meaning of increased number of doses reduced number of doses continuation in a series of procedures repetition of a series of procedures reduction of the number of procedures immediate discontinuation of procedure administration and the like e The user of the device VAS 07 BETTER FUTURE edition is bound to ensure the device against the risk of fire in a manner that is similar to other electrical appliances supplied from the power supply network Any abnormal temperature rise of the device or any of its parts is a reason to its immediate switch off disconnection from the power supply and subsequent calling a professional repair service e Ventilation openings or encapsulated parts of the device must not be covered under operation of the device and the device must not be hermetically closed e tis necessary to prevent from ingress of foreign objects and liquids into the device undesirable vibrations and sudden temperature changes e lfarisk of moisture condensation exists condensation of air water vapours in transfer from colder to warmer areas the device can be switched on only if it is completely dry e Covers of the device ma
48. ectrotherapeutic devices of various manufacturers as well as on the basis of medical experience with the previous types of the device VAS 07 manufactured by the company Embitron In this manner 131 diagnoses and indications of 341 pulse and 319 interference electrotherapeutic currents is programmed in the device VAS 07 BETTER FUTURE edition within the framework of the Standard Procedures folder Individual diagnoses are structured according to indication groups vertebrogenous diseases degenerative diseases inflammatory diseases diseases of veins and lymph bone diseases traumas and similar diseases diseases of muscles and nerves entezopathy and other as well as according to localisation of problems 21 localities on the patient s body Note Application of electrotherapeutic current according to localisation of problems is very effective under normal practical conditions therefore all these 21 locations are schematically represented on the indication and control panel of the device In addition to pre programmed electrotherapeutic currents the user of the device VAS 07 BETTER FUTURE edition can develop other electrotherapeutic currents with fully individual parameters namely in the User Procedures folder Any of the electrotherapeutic currents from the Standard Procedures folder as well as from the User Procedures folder can be stored in another separate folder named Favourite Procedures with a view of t
49. ee Luxatio Tendovaginitis chronica Lymphoed ema Oedema acuta Oedema chronica Omarthrasis omalgia Osteosynthesis Ulnarthrosis ulnpathia User s Manual VAS 07 BETTER FUTURE edition Locality elbow Locality 15 paravertebral Locatisatio 15 P4 Analgia Analgesia Dorsalgia Haematoma acuta Haematama chronica Hypertania musculorum Hypotonia musculorum Musculus abbreviatus Musculus scissus Myalata Myagelosis Mvopathia Wyorelaxatia Neuralgia ov Tietz Tonisatio muscularum User s Manual VAS 07 BETTER FUTURE edition Locality paravertebral Locality 16 lumbar LOCALISATIO 16 Analgia Analgesia Contractura Degeneratio spinalis Dorsalgia Hypertonia musculorum M Bechterevi Musculus abbreviatus Myalgia Myoaqelosis Myvorelaxatio Osteachandrasis Osteochondrosis Osteoporosis opasticis myaspasmus Spondvylarthritis ancylapaetica Sy vertebralis VAS acuta Sv vertebralis VAS chronica Locality lumbar 25 Locality 17 tarsus LOcALISATIO 17 Locality tarsus Achilladynia Algodystrophic syndrom lower limb Analgia Analgesia Arthrosis acuta exacerbans Atthrosis chronica Arthrasis aedematosa Calcar calcanei Decubitus Luxatia Lvmphoedema Metatarsalmia Dedema acuta edema chronica Sanatia postoperativa Sanatio pasttraumatica Tendinitis acuta Tendinitis chronica Tendapathia Tendovaginitis acuta Tendovaginitis chronica User s Manual VAS
50. ented and schematically it is shown that the pulse electrotherapeutic current was used and the procedure is running running rectangles and parameters of the procedure are specified in a summary manner After pressing the START STOP 10 button you can terminate the procedure course or to continue after repeated pressing this button During the procedure termination the time count will be stopped If you want to stop the procedure prematurely before the expire of the selected procedure time press the button C 11 A query will appear in the display 8 whether you really want to terminate the procedure or repeat it from the beginning or to save it in a special Favourite Procedures folder If your decision lasts more than 10 seconds this prompt will disappear and the procedure course will appear in the display After pressing the button C 11 you will return to the previous state m n OOR gt T iD MORIN Ew c9 T If the procedure is terminated prematurely you will return to the basic menu The MENU button has a totally different function as the button C If the interference electrotherapeutic current is selected the further procedure is fundamentally identical with the pulse current The automatic termination of procedure will occur after the elapse of a pre selected procedure time This termination is indicated by the high tone sound lasting for appr 5 seconds In this case y
51. ents Metallic implants in the patient s body most frequently during osteosyntheses or application of endoprostheses The risk of temperature rise or mechanical vibration of the metallic implant exists here Vibration risks are absolutely negligible Temperature rise of the metallic implant in use of pulse currents is minimal In use of generally more effective interference currents the temperature rise may be quite evident but in the majority of situation this does not exceed physiologically acceptable values Nevertheless increased caution should be taken when prescribing and applying procedures This is exclusively a local contraindication oevere neurological and seizure diseases Theoretically during DE application the central nervous system CNS could be interfered with the created induced electric currents This is a local contraindication In a sufficient distance from the CNS localisation DE procedures can be administered The officially determined distance is 25 cm from the applicator for pulse currents and 50 cm from the applicator for interference currents The manufacturer recommends doubling this distance i e up to 50 cm from the applicator for pulse currents and up to 1 metre from the applicator for interference currents In patients with seizure conditions visually sensed action of phototherapy is not admissible as the flashlights could give rise to a seizure In seriously neurovegetatively unstable patients DE proce
52. es of vital organs Here purely theoretically during application of DE a discrepancy may occur between the requirements of tissues for oxygen and inability of atherosclerotic arteries to supply oxygen This potential risk regards in particular the heart or the brain The real manifestation of discrepancy however has never been reported In addition this is a local contraindication In a sufficient distance from the affected vital organ DE procedures can be administered The officially determined distance is 25 cm from the applicator for pulse currents and 50 cm from the applicator for interference currents The manufacturer recommends doubling this distance i e up to 50 cm from the applicator for pulse currents and up to 1 metre from the applicator for interference currents Heart rhythm disorders disorders of electrical transmission heart system and any related heart diseases Theoretically during DE application the electric heart transmission system could be interfered with the created induced electric currents This is a local contraindication Ina sufficient distance from the affected vital organ DE procedures can be administered The officially determined distance is 25 cm from the applicator for pulse currents and 50 cm from the applicator for interference currents The manufacturer recommends doubling this distance i e up to 50 cm from the applicator for pulse currents and up to 1 metre from the applicator for interference curr
53. f these currents can be easily read from the menu table At pulse currents marked IMP Imp is specified Imp duration of exciting pulse us microseconds f first used therapeutic frequency Hz T time of action of the first therapeutic frequency used during each period ms fij second used therapeutic frequency Hz time of action of the second therapeutic frequency used during each period ms At interference currents marked INT the frequency base value Hz is specified i e the lowest applied frequency of heterodynes interference Swing sometimes also designed as Stroke is a frequency by which the base lowest used therapeutic frequency is periodically increased Hz Spectrum sometimes designed as Spectral program expresses the manner in which the base lowest applied frequency Base will proceed to a higher frequency determined by the sum Base 4 Swing and back Note This change can be realised By gradual linear growth and subsequent immediate decrease schematically shown with a triangle a triangular course By gradual linear growth and subsequent dwell on the maximum applied frequency for a certain amount of time whereas the therapeutic frequency will be gradually linearly decreased to the minimum applied frequency i e base the lowest applied frequency which is again applied for a certain amount of time schematically designed with a trapezoid
54. fection means according to the Disinfection Order of a particular health facility and or decision of a responsible physician health care professional but using only means which not contain alcohol means which do not leave colour traces or discolouration or damage of surfaces of the device friendly application of disinfecting means Important notes During cleaning and disinfection of the device the device must be switched off by withdrawal of the mains plug from the mains socket must be ensured that any liquids or particles will not ingress into the inside of closed encapsulated parts of the device intelligent instrument unit 2 and applicator 3 CAUTION The applied part of the device is not intended for contact with a non intact damaged or problematic and hypersensitive skin 4 5 Maintenance Routine maintenance performed by the operating personnel consists only in a regular and on going integrity check of those parts of the device that effect its safety as described in this manual as well as maintenance of the device in cleanness or its disinfection if required In addition the operating personnel must observe the instructions specified in this manual or any apprehensible changes in appearance and function of the device or its individual parts If any discrepancies are found the authorised service should be contacted 4 5 1 Regular Functional and Safety Checks of the Device As the device VAS 07
55. he patient should be positioned in a suitable manner in laying position sitting position or in semi laying position to prevent the risk of fall to assist the patient with standing after the procedure and ask for a short time monitoring under the supervision of a health care professional 2 7 2 3 Side Effects The professional medical literature reports that carrying electromagnetic fields and induced electric currents may act synergically with antibiotic drugs and phenylbutazone act antagonistically with steroids nitrates calcium antagonists and beta blockers decelerate the effect of heart glycosides User s Manual VAS 07 BETTER FUTURE edition 31 The most important side effect for the patient however can be increased soreness after administration of the first or several initial procedures This effect called the reactive phase is usually explained on the basis of mechanism of created superoxides and it is one of the proofs of the effective action of DE Similar effects are known and theoretically explained also at other forms and types of physical therapy After the transient increase of soreness following one to three initial procedures a significant decrease in pain is followed along with other favourable effects of physical therapy If however the transient increase in soreness is too high it is necessary to reduce a dosage scheme to shorten the procedure time to decrease the current intensity to select a
56. heir further quick and operative use under a selected name or patient s symbol or procedure In addition the device VAS 07 BETTER FUTURE edition contains additional more than 100 programs intended for application of special procedures for example for transcutaneous electrical nerve stimulation TENS application of Nogier Bahr Claus and Reininger frequencies application of frequencies to achieve cyclotron resonation in order to influence electrically charged particles passing through the cell membrane The front side of the therapeutic applicator of the device VAS 07 BETTER FUTURE edition which is to be applied to a treated part of the patient s body is equipped with powerful red light emitting LED diodes This represents secondary phototherapy applied simultaneously with distance electrotherapy In order to increase its effect the therapeutic luminous flux is polarised and modulated by its own universal frequency program independent on used frequencies of distance electrotherapy User s Manual VAS 07 BETTER FUTURE edition 4 2 General Information 2 1 Device Manufacturer EMBITRON s r o Borska 55 301 00 Plzen Czech Republic www embitron cz www embitron eu embitron embitron cz plzen embitron eu 2 2 Authorised Distributor and Service For the Czech Republic EMBITRON s r o Borska 55 301 00 Plzen Czech Republic For the Slovak Republic EMBITRON s r o Borska 55 301 00 Plzen Czech Republic For
57. ic fields and radiation the State Health Institution in Prague According to the viewpoint of the international commission ICNIRP and Governmental Order of the Czech Republic No 480 2000 Coll in conformity with the requirements of the Operating mode of the device European Union in applying the DET procedure it is necessary to meet the following distance from the applicator for OPERATOR for OTHER PERSONS The manufacturer recommends doubling the distance from the applicator in the course of running proceaure i e 0 5 metre for the operator and 1 m for other persons Pregnant women and persons using electronic prostheses must be fully ruled out from operation of this device as well as from administration of procedures User s Manual VAS 07 BETTER FUTURE edition 3 The VAS 07 BETTER FUTURE edition is a medical device intended for professional use in the health sector in order to provide physical and therapeutic procedures of distance or contactless electrodeless electrotherapy utilising the physical and therapeutic effect of eddy electric currents developing on the basis of Faraday electromagnetic induction created in the tissues being treated when a device applicator is located in close proximity of these tissues The evident and well proven biological activity reaches up to the distance of approximately 25 cm from the applicator The device produces two 2 basic types of electrotherapeutic currents pulse curren
58. ility during the procedure The usual upper limits are often 50 Hz 100 Hz or 200 Hz The goal of this therapy is to enable the treated tissue to utilise any of the offered frequencies in situation when exact values of required therapeutic frequencies are not known At the same time this therapy can eliminate the undesirable habit for electrotherapy and associated reduction in therapy effects in particular pain therapy Stochastic therapy is also used in a regulatory medicine In addition to the folders Standard Procedures Favourite Procedures and User Procedures the basic menu also contains a folder named Special Procedures Basic Menu This folder includes therapeutic procedures whose parameters are based on theories expressed by physicians or scientific and research workers in the field of medicine These theories are generally known many physicians prove therapeutic effectiveness on the basis of these theories but theories are not fully acknowledged in general The Special Procedures folder is divided into two sub folders User s Manual VAS 07 BETTER FUTURE edition 54 information Therapies and Cyclotron Resonance The Information Therapy folder includes in particular electrotherapeutic currents for transcutaneous electrical nerve stimulation TENS the item Transcutaneous Nerve Stimulation Special Procedures Information Therapy Individual currents from these electrotherapeuti
59. ion it must not be disposed of as municipal waste but it must be dismounted to individual components as outlined below stand 1 2 instrument unit 2 Cs applicator 3 detachable mains supply 13 1 Dismounting is performed in a simple way in threaded joints The metallic stand 1 is to be disposed of as ferrous waste and scrap other parts as electrical equipment No dangerous waste is included The device does not produce any waste products that have the excessive environmental impact On disposal of the device contamination of device parts from bodies of treated patients should be considered Important notice With regards to its natural wear and tear material ageing and in particular moral ageing to which all electronic devices are exposed the life time of the device is 10 years For this period of time service and possible deliveries of spare parts are ensured 4 7 Packaging The device is packaged into inert protective packing foils In this manner packaged device can be transported only by the manufacturer For common transport the device is placed into a shipping case protected by foam rubber filling and fixed with fixation boards if necessary In addition the shipping case must contain the Accompanying User s Documentation User s Manual The shipping case must be properly marked 4 8 Storage The following storage conditions are to be applied The temperature of 5 to 45 without
60. itis Cicatrix cheloidea Cicatriz chronica Cicatriz recens Dolor p e postoperativa Dolor postextractionem stomatologia Dolor temporomandibularis Dupuytren s contractura Eczema Chelaidum Metatarsalgia Musculus abbreviatus Myalgia MMyvogelosis MMyvorelaxatio Meuradermatitis bstipatio atanica bstipatio spastica acuta Oedema chronica Parodontis stomatologia Pelvipathiae Regeneratio cutaneus sensibilitas otimulatia medullae asteae ow Tietz Tension headache Tonisatio musculorum Triger points profundus deep Trigger points superficialis 18 2 7 1 2 Classification According to Treated Localities Locality 1 neck LOCALISATIO 1 Analgia Analgesia Cantractura Degeneratio spinalis Hypertonia musculorum Migraena Musculus abbreviatus Myalgia Myogelosis Myorelaxatio Neuralgia n occipitalis Spasticis myospasmus Sv cervicalis Sv cericobrachialis Sv cericocranialis foccipitalis Sv vertebralis VAS acuta Sv vertebralis VAS chronica Tension headache Torticollis Triger points profundus deen Trigger paints superficialis Localitv neck User s Manual VAS 07 BETTER FUTURE edition cov vertebralis Locality 2 sacroiliacal LOCALISATIO 2 Locality Adhaesio dolorosa Analgia Analgesia Claudicatio intermitens Contractura Degeneratio spinalis Hypertania musculorum Ischialgia Musculus abbreviatus Myalgia
61. mmediately switched off detachable mains supply cord disconnected from the line power supply and subsequently the authorised service should be contacted if any or more of the below specified cases occur the detachable mains supply incoming mains cord is damaged or worn out the device is exposed to action of water or other liquid which would leak into its interior the device does not work normally changes in performance or behaviour can be seen non typical sounds can be heard or smoke fume or any odour can be felt the device was damaged by fall or impact the device shows damaged covers encapsulated parts instrument unit applicator and or parts responsible for mechanical stability special care should be taken to integrity and function of fixation ball threads at the spherical head of the applicator and on the vertical guide rod the supply cable for connection of the applicator or its connectors is damaged e The front side of the therapeutic applicator of the VAS 07 BETTER FUTURE edition which is to be applied to the treated part of the patient s body is equipped with 24 or 40 powerful red light emitting LED diodes This represents supplementary phototherapy applied simultaneously with electrotherapy Although the luminous flux does not reach dangerous values for human eyes the manufacturer does not allow to look directly at this light from a distance lower than 2 m or to look at the emitting area of
62. nector secured using an union nut The plug connector must be slightly inserted full length it is impossible to insert it in a wrong way as it is provided with a lock Special care must be taken to connection of connector 12 for connection of the applicator to the instrument unit 2 as a dangerous voltage of up to 150 V can be generated on this connector during operation of this device Further installation consists in connection of the detachable mains supply 13 incoming mains cord First insert the plug connector into the appliance inlet at the rear panel of the instrument unit then insert the plug into the electric socket outlet Important instructions for the operating personnel It is necessary to have a duly protected electrical mains distribution 230 V 50 Hz AC properly rated to electrical consumers with an input of 25 VA protection class ll Do not connect the device to the mains distribution system if it was dewy after transport in a cold environment or if you find any deficiencies or damage of any part of the device due to transport Before connecting the device VAS 07 BETTER FUTURE edition it is necessary to acquaint thoroughly with the Accompanying User s Documentation User s Manual In addition grip firmly the applicator arm 4 slightly release the tightening handle 9 of travel 7 on the vertical guide bar 8 and turn the applicator arm 4 with the applicator 3 in such a way that the applicator
63. nly potential contraindications considered only theoretically and important mainly from the view point of preliminary caution Absolute and Objective Contraindications Administration of DE procedure to a patient with the implanted electric stimulator for example most frequently cardiac pacemaker or any electronic prosthesis influencing vital functions for example electronically controlled administration of insulin or to a patient whose vital functions are monitored or controlled by electronic devices connected to the patient s body for example at the intensive care unit Electromagnetic fields and induced electric currents of the device VAS 07 BETTER FUTURE edition will not damage the patient directly but they would case a defect in function of electronic instruments or vital implants Administration of DE procedure to a patient in a serious health condition requiring totally different therapeutic procedures This regards for example cardiac patients with a serious infectious disease patients under acute attacking conditions patients with hypertonic or hypotonic crisis patients with glycemic crisis patients in the anaphylactic shock or symptoms of allergic reaction acutely intoxicated patients in a serious condition and the like Pregnancy Basically this is a local contraindication regarding the abdominal area of women in which a foetus is being developed According to international directives the saf
64. nnector on the board The electric connection applicator cable 11 is a stranded four core polyurethane cable with double insulation which is inseparately connected to the encapsulated applicator with a grommet 15 In the optional manufacturing version connection of the applicator cable 11 with the therapeutic applicator 3 is ensured using a highly resistant threaded joint connector A voltage of 150 V can be present after connection of the applicator 12 12a as well as on the applicator cable 11 and on coils inside the encapsulated applicator 3 The safety is ensured by double and multiple insulation and robust and quality manufacturing design User s Manual VAS 07 BETTER FUTURE edition 36 Important instructions for the operating personnel In the event of any damage to connectors after connecting the applicator positions 12 12a 12b in Fig 3 1 applicator cable 11 grommet 15 or whole closing encapsulation of applicator 3 the device must be immediately switched off and disconnected from the mains and authorised service must be contacted Naturally the operating personnel must be particular in avoiding the possible damage of the mentioned device parts 2 12 16 INTELLIGENT CONNECTOR MATRIX INSTRUMENT UNIT TO CONNECT OF EMISSIVE THE APPLICATOR DIODES FOR PHOTOTHERAPY 22 A 3 APPLICATOR 15 FIRM GROMMET OR CONNECTOR ON THE APPLICATOR APPLICATOR STRANDED CABLE
65. nt 12 12a 12b Iz ISIS le I 5 2 lo a es a Figure 3 1 Device overall assembly i devicestand o oS A 2 inteligentinstrumentunit 4 swiveling arm ofthe applicator 5 sphericalhead 6 tightening element ofthe spherical head 9 tigheninghande 10 safetyspring o o 11 applicator stranded cable 12a 12b 12a appliance inlet 12b connector 13 mains powercord O Z 14 brakedwheels O Z o 15 firm grommet or connector on the applicator matrix of emissive diodes for phototherap On the opposite side the applicator arm is fixed to a travel with spherical bushes 7 This travel enables vertical movement of the applicator In doing so the travel with spherical bushes 7 slightly moves along the vertical guide bar 8 namely after release of a tightening handle 9 CAUTION Before releasing the handle 9 the applicator 3 or its arm 4 must always be firmly gripped and held Otherwise after releasing the handle 9 the applicator 3 and its arm 4 would fall This fall can result in damage of the device or injury of persons Important instructions for the operating personnel Never release the handle 9 of applicator vertical travel on the guide bar 8 without firmly and permanently holding the applicator 3 and or its arm 4 The risk of possible damage
66. nt it can be declared in general that at interference therapeutic currents applied in the form of DE using the device VAS 07 BETTER FUTURE edition can be expected more significant and faster therapeutic effect however associated side effects such as increased soreness during the first and several first application may occur During application of interference currents it is also necessary to take care of relative contraindications for example heating of endoprothesis material Pulse currents however can also be effective enough in many cases that they can exceed generally more radical interference currents especially if these currents are close to TENS type currents for pain relief on the basis of return theory or on the basis of endorphin production stimulation and currents close to SP type according to Professor Basset intended to support healing and neovaskularisation and the like CAUTION Interference currents produce in the treated tissues up to 10 times higher current density than pulse currents Selection of a particular pulse or interference current is made again using the buttons A 13 V 14 Let us select for example the second from the offered currents Lumbald1a and confirm your selection by pressing the button 12 In the display 8 the detailed description of biotropic parameters of the selected therapeutic current will appear Luwbaldia lmPulse Ao D EE Time Impulse Freduengy im
67. ntelligent instrument unit Chapter 4 3 of this manual The front panel of the intelligent instrument unit schematically shows 21 localities of the locomotor system with the most used procedures of the device VAS 07 BETTER FUTURE These illustrations correspond with the offer of electrotherapeutic procedures for these localities in diagnoses in which they are typically occurred see Chapter 2 7 1 2 and Chapter 4 3 Inside the intelligent instrument panel casing position 2 in Fig 3 1 position 1 in Fig 3 2 1 and 3 2 2 there is located a highly versatile and safe mains transformer encapsulated in a separate cover On the primary winding of this transformer 230 V AC should be present by default By simple modification of the transformer block interconnection of two prepared conductors this supply can be changed to 115 V AC and the device can be used in another electrical network This modification can be performed only by the manufacturer or authorised service In the vicinity of the transformer there is a filter ensuring requirements for electromagnetic compatibility Voltage of the secondary output of this transformer is 18 V AC which is led in a separate circuit to a printed circuit board PCB This board resolves a decisive part of device electronics The work of this device is controlled and continually monitored by the microprocessor of ATMEGA 128 type In the memory of this microprocessor there are stored all pre programmed ther
68. of electrically conductive entases in the body as well as the risk of undesirable temperature rise of the applicator or instrument unit Inside the instrument unit there are special sensors monitoring temperatures at various places of electronic connection and if acceptable limits are exceeded the current period value duty cycle will automatically be reduced or application will be automatically terminated In the following we will show for example how to modify the procedure time By pressing the button 12 you will come to the right part of the parameter table and by pressing the buttons A 13 V 14 the information can be modified for example the procedure time will be shortened up to 15 minutes A similar procedure will be used if other parameters are modified LumbalYia ImPulse Frequency Tine Impulse Freguency m mum D P Ca Ps P3 16 C4 Laima Uy riu vr Ui Time Current Fe OM cw uli c ee ae II Procedure Time Intensity Current Period 0 50308 Press STAR The start of an individual therapeutic procedure will be made by pressing the START STOP 10 button and a relevant indication will appear in the graphical display Tr 2 aln a User s Manual VAS 07 BETTER FUTURE edition 46 The diagnosis is shown in the upper part of the display showing the remaining time of procedure the time is deducted decrem
69. of the equipment by fall of the applicator 3 with its arm 4 and travel 7 is decreased using a safety spring 10 located at the bottom of the guide bar 8 The applicator is electrically connected to the instrument unit by the applicator cable 11 This cable is terminated with a connector for connection of the applicator to the instrument unit 12 12a 12b This applicator cable 11 is connected to the fully enclosed applicator body 3 by means of a grommet or connector 15 The intelligent instrument unit 2 and the entire device VAS 07 BETTER FUTURE edition is to be connected to the electrical line by the mains power cord The entire device assembly is moved on a device stand 1 by means of braked wheels 14 User s Manual VAS 07 BETTER FUTURE edition 33 3 2 Description of the Intelligent Instrument Unit The intelligent instrument unit position 2 in a Figure 3 1 position 1 in Figure 3 2 1 is 3 the base unit of the device VAS 07 BETTER FUTURE edition From the electric viewpoint this is a device of Class with the line power supply The device is placed in a plastic casing box position 2 in Figure 3 1 position 1 in Figure 3 2 1 The standard AC power supply network is 230 V 50 Hz The device can be simply adjusted to 115 V AC power supply network The power supply voltage is supplied using the detachable power supply cord 2 with a power supply plug 3 and plug connect
70. operative Gonarthrosis ganalgia Haemarthrasis Chondropathia patelae Laesio ligamenta cruciata Laesio menisci Dedema acuta edema chronica Sanatio postoperativa Sanatio posttraumatica User s Manual VAS 07 BETTER FUTURE edition Locality rear chest Locality front knee Locality 6 shoulder LOCALISATIO 6 Frozen shoulder Haemarthrasis Omarthrosis omalgia Periarthritis humerascapularis Sanatio postoperativa Sanatio posttraumatica Locality 8 hip LOCALISATIO 8 Alloplastica Analgia Analgesia Anhrasis acuta exacerbans Anhrasis chronica Athrasis aedematasa Dlorsalgia Fractura M Perthes steonecrosis aseptica Osteapathia Osteoporosis Osteasvnthesis Pseudoarthrosis ununited fractures 21 Locality shoulder Locality hip Locality 9 thigh LOCALISATIO 9 Contractura Distensio muscularis Enthesopathiae Haematoma acuta Haematoma chronica Musculus abbreviatus Musculus scissus Miyalaia Mvagelasis Myopathia Miyorelaxatio Fost poliomyelitis syndrom Spasticis myospasmus Tonisatio musculorum User s Manual VAS 07 BETTER FUTURE edition Locality thigh Locality 10 side knee LocaLisatio 10 E Es th b t z f 27 i 5 i Analgia Analgesia Bursitis acuta Bursitis chronica Cantusio Distortio Enthesonpathiae Fractura Haematoma acuta Haematoma chronica Laesio ligamenta cruciata Luxatio M Osgood Schaltter
71. or 4 The plug connector 4 is to be inserted in the appliance inlet 5 at the rear panel of the instrument unit 1 plastic case rear panel O Z o Figure 3 2 1 2 detachable mains cord Rear panel of the instrument unit 8 mains plug 4 plug connector 5 appliance inlet 6 power switch connector appliance inlet to connet applicator 12a see also Fig 3 1 Important instructions for the operating personnel When putting the device into operation the detachable power supply cord 2 with the plug connector 4 must be connected to the appliance inlet 5 on the body of the instrument unit first and then the mains cord 3 is to be connected to a mains socket When disconnecting the device from the electrical distribution system the procedure is opposite At the device switched off by the power switch 6 the mains plug 3 should be withdrawn from the mains socket then the plug connector 4 and appliance inlet may be disconnected and detachable main inlet 2 disconnected The device VAS 07 BETTER FUTURE edition may use only the detachable main inlet mains power cord provided by the manufacturer as part of the device In the event of its loss or any damage it is necessary to replace it only with a mains inlet cord provided by the manufacturer or authorised service The operating personnel must carefully check the condition of the mains inlet cord and in the event of
72. ou will be prompted to make a decision whether you really want to terminate the procedure or repeat it or to save its parameters to the Favourite Procedures folder The menu in the display is identical with the menu shown in Fig 4 3 10 If you decide to save the finished procedure to the Favourite Procedures folder the following keyboard will appear in the display Favourite Procedure Savins Name Entering Save Not Save User s Manual VAS 07 BETTER FUTURE edition 47 You will access the key field by pressing the button 12 By pressing the buttons A 13 V 14 you can select a particular sign and after pressing the button 12 you will move to the filed of favourite procedure name this may be a symbol abbreviation patient s name diagnosis and the like This procedure is to be repeated for every sign of the alohanumeric chain After finishing the text use the button A 13 to move to the item Save and confirm this by pressing the button 12 You can return to the basic menu any time by pressing the button MENU 9 however if the procedure is running the procedure must be finished first If the pre programmed Standard Procedures are selected from the basic menu but you do not want to use the selection of therapeutic program according to indication groups but according to localisation of patient s problems select the item Trouble Localisation and confirm by pressing the button 12 A selection from 21
73. period of time cover it or pack into a protective foil Under normal operation dust should be regularly wiped suctioned or removed using soft and dry means If considerable impurities need to be removed use a soft gauze cloth or sponge slightly User s Manual VAS 07 BETTER FUTURE edition 57 humidified with water or a friendly cleaning agent Never use alcohol based cleaning agents or abrasive means Important note Alcohol based cleaning agents or abrasive means must never be used for cleaning of the device or its parts The applicable part of the device applicator 3 Fig 3 1 can be applied to the patient s body in such a way that it will not get in contact with the patient s body Induced electric therapeutic currents are created in treated tissues also in the presence of air gaps and obstacles between the front area of the applicator and patient s body such as clothing plaster gypsum plaster and the like This fact can be used sometimes and patient s non intact or problem skin should be covered with a sterile bandage towel and the like In this manner the action of supplementary phototherapy is prevented but the electrotherapeutic function of the device is not affected in any way If in spite of these measures the applied or other part of the device is contaminated and or the device must be disinfected before use by another patient disinfection of any part of the device can be made using common disin
74. pulse and medium frequency electro therapeutic currents without the need to apply contact electrodes on the patient s body with the aim of achieving favourable therapeutic influencing of painful conditions and to support healing regeneration or repair of the locomotor system tissues Relevant physical and therapeutic procedures are referred to as distance electrotherapy DET Fig 1 Caution If the device is switched on and the procedure is started the operator of this device must not be closer than 15 cm from the applicator in use of pulsed currents and 25 cm in use of interference currents other persons must not be closer than 25 cm from the applicator in use of pulse currents and 50 cm in use of interference currents according to assessment of exposure situation at the electrotherapeutic device VAS 07 BETTER FUTURE edition and according to the limits stipulated in the governmental order of the Czech Republic No 480 2000 Coll on health protection against non ionizing radiation in conformity with the Regulation for limiting exposure by time varying electric magnetic and electromagnetic fields of the ICNIRP commission International Commission on Non lonizing Radiation Protection Guidelines for Limiting Exposure to Time Varying Electric Magnetic and Electromagnetic Fields in accordance with the legislation of the European Community measured by the accredited National reference laboratory for non ionizing electromagnet
75. r the patient without being endangering This regards supportive therapy of some functional and vegetative and regulation processes in the organism or possibility to use specific frequencies with anticipated biological effects Nogier Bahr Claus and Reininger frequencies resonation cyclotron frequencies and other applied within the framework of acupuncture especially at contactless ee UE of introduced acupuncture needles as well as in regulatory and holistic medicine Dosage of DE is always individual whereas therapeutic benefits and possible risks must be taken into consideration The procedure time is usually 15 to 30 minutes for interference electrotherapeutic currents and 15 to 60 minutes for pulse electrotherapeutic currents In well substantiated cases the time of one application can be doubled for example in treatment of fractures aseptic bony necroses venous ulcers acute posttraumatic pain and the like As a rule procedures are administered on a daily basis less frequently every other day in a series of mostly 10 to 20 procedures with a possible repetition of this series several times a year usually 2 to 4 times In some indications in particular support healing applications fractures ununited fractures bony necroses venous ulcers and other thropic defects and the like it is possible to apply continuously also other series of procedures if a therapeutic benefit is clear and no risks exist In painful conditions at
76. rly as with other devices producing electromagnetic fields also with the device VAS 07 BETTER FUTURE edition it is necessary to avoid contact with magnetic fields with instruments devices and technical means that are sensitive to action of electromagnetic fields can change properties and function due to their influence or can be damaged by them for example computers monitors memories data carriers electronic recording equipment electronic watches chip code cards and the like similarly as all other usual electric instruments The manufacturer of the device VAS 07 BETTER FUTURE edition does not answer for damage arising from failure to meet this requirement e CAUTION Special care should be taken to the fact that no invasive and non invasive electronic means ensuring vital functions of patients must get into influence of electromagnetic field of the applicator of the device VAS 07 BETTER FUTURE edition Even though the device meets all internationally acknowledged requirements for electromagnetic compatibility the above mentioned safety precautions must be observed e he detachable mains supply incoming mains cord of the device VAS 07 BETTER FUTURE edition must not be located in areas where the cord could be interrupted or violently pulled out from a socket of electric distribution network or appliance inlet on the real panel of the instrument unit e he device VAS 07 BETTER FUTURE edition must be i
77. rtebralis AS chronica Tendapathia UInarthrasis ulnpathia fetema articulatia sacrailiacalis Sl 15 Inflammatory diseases Morbi inflammationae Acne Adhaesio dolorosa Achilladvnia Arthritis rheumatica Arthritis urtica Amnhrasis acuta exacerbans Amnhrasis aedematasa Bursitis acuta Bursitis chronica Celulitis Frozen shoulder Mi Bechterevi Omarthrosis omalgia Listeachondrasis Cistitis Pelvipathiae Fertarthritis humerascapularis Feriostitis opondyvlarthritis ancylopoetica otriae Sy Tietz Tendinitis acuta Tendinitis chronica Tendovaginitis acuta Tendovaginitis chronica User s Manual VAS 07 BETTER FUTURE edition Circulatory disorders Morbi vascularae et lymphae Acrocyanosis Acroparaesthesia acrodysaesthesia Algodystrophic syndram lower limb A lgadystraphic syndrom upper limb Atherosclerosis ischaemia peripherica Claudicatio intermitens Decubitus Dupuytren s contractura vmmphaedema M B rger hM Raynaud Migraena MWikroanqgiopathia edema acuta edema chronica Pseudaarthrasis ununited fractures Regeneratio cutaneus sensibilitas 8 oy canali carpi cw Sudeck cw varicasurrm Ulcus cruris w asaneurasis universalis 16 Osteopathies Morbi osteae Algadystraphic syndrom lower limb Algadystrophic syndrom upper limb 8 Osqood Schaltter Wl Perthes steonecrosis aseptica Osteopathia Osteoporosis Cisteasynthesis Cistitis Pseudoarthrosis
78. t at the same time each of the exciting currents is precisely measured by means of galvanically separated sensors The mentioned values are provided to the microprocessor which tunes via the feedback the optimum resonance frequency at which the required therapeutic currents are created accompanied by a rotating vector of the electromagnetic field This solution is patent protected too In addition the microprocessor creates a frequency program for supplemental phototherapy with LED diodes using the red wave length of 660 nm Pulses for phototherapy with various lengths of 3 ms to 100 ms are repeated with selected frequencies of 2 to 160 Hz 22 various frequencies with various pulse lengths are used in total These 22 frequencies were carefully selected to cover the entire frequency spectrum usually used in biostimulation phototherapy The physician does not need to care of selection of necessary frequency of supplemental biostimulation phototherapy Each frequency is applied for a duration of 5 to 30 seconds The entire offer of 22 selected frequencies is provided in 5 minutes and the whole cycle is repeated up to completion of DE procedure The therapeutic applicator itself position 3 in Fig 3 1 is electrically connected via the connector 12 whose appliance inlet 12a is located at the rear part of the instrument unit case This appliance inlet 12a is connected with the PCB inside the instrument unit with a cable provided with a co
79. the applicator even from a higher distance As this light is modulated with various frequencies it appears in the form of irregular rhythmic flashes In sensitive persons looking at these flashes should cause problems dizziness nausea and the like therefore these persons should not be allowed to look at this supplementary phototherapy In photosensitive persons it is also necessary to exclude the action of this supplementary phototherapy on skin Phototherapy must not be administered shortly after application of CO injections e The use of the device VAS 07 BETTER FUTURE edition must never became a reason for failure to perform or taking away other necessary medical care procedures User s Manual VAS 07 BETTER FUTURE edition 8 e Inthe course of operation of the device running therapeutic procedure it is not allowed to handle the applicator and or disconnect its electric supply cable e he operating personnel must not touch the running applicator If the applicator s position must be adjusted this must be performed at the time when administration of electrotherapeutic procedure is not running e The device may be operated only with a fully inserted and secured connector connecting the instrument unit with the device applicator CAUTION The electric voltage on the connector for connection of the applicator cable can reach the peak value of 150 V The warning sign at the APPLICATOR connector on the rear side of the
80. tion MSO13485 2008 Countryoforigin Czech Republik European Union Electrotechnical classification Insulation class Health classification Il a in accordance with EU Council Directive 93 A2 EEC Electrotechnical standard used Electrotechnical standard used CSNEN60601 1 equiv IEC 601 1 manufacturer 115 V 60 Hz Electric input_ Electric input EB Enclosure of encapsulated parts 6 41 60 529 Ts of applied part of device BF GEN EN 60 0 1 equiv IEC 601 1 Month and year of manufacture Serial number 000002 Warning 1 A peak voltage of up to 150 V can be present on the connector for connection of applicator as well on the applicator cable 150V and in the applicator Warning 2 Observe the safe distance from the applicator at its turn on It does not regard the patient being treated It regards the operating personnel and other persons in the vicinity of the device applicator This distance is 15 cm for the operating personnel resp 25 cm for other persons Fuse Applicator connector connector Obligatory reference to the Product Documentation User s Manual VAS 07 BETTER FUTURE edition 38 4 Operation of the Device VAS 07 BETTER FUTURE Edition 4 1 Installation of the device The device VAS 07 BETTER FUTURE edition can be installed in a very simple way because the unit is mostly pre assembled The devi
81. tion of the Device eese eese rere eene nnn 33 Description of the Device Assembly 33 Description of the Intelligent Instrument Unit cceceeeeeeeeeeeeeeeeeeseeeeeesaeeeeeseeeeeneees 34 Legend Description on the Device eeessesesesseeeenneeen nennen nnns 38 Operation of the Device VAS 07 BETTER FUTURE Edition 39 Inisiallatlonm ohe deviCe siste uinea de Ieecus ete ve tp caesa rut esi Da ttp eL UU uerba e EAE Ue euge aie 39 Operation of Mechanical Parts of the Device eeeeeeseseeeseeeseeeeeenneeeennn nnn 41 Operation of the Instrument Unit of the Device VAS 07 BETTER FUTURE Edition 42 Cleaning and DISimieC on diee iau reor beete etel iie e eu e Prat oe aste M ecce eee 57 Ms nsigcigie cim M 58 Regular Functional and Safety Checks of the Device cccceecccccseecceseeeeeeeeeeeeeesaeeeeeeees 58 Environmental Protection and Disposal of the Device eeeeesseeeeeeeeee 59 AC AC IG Pme NE EM 59 jrelrc e ee uto C MM 59 MAIS DOU ee ERE 60 Environmental Conditions Under Operation of the Device VAS 07 BETTER FUTURE UTC Te iar ER rM 60 Cer cation uu ud NUN IE ED EE EM en d EU 61 User s Manual VAS 07 BETTER FUTURE edition 2 1 Intended Use and Basic Description of the Device The purpose of the device VAS 07 BETTER FUTURE edition is to provide low frequency
82. tion on eyes On the contrary the benefit is reported in treatment of some degenerative eye diseases for example macular degeneration Application to changed manifestations of skin pigmentation Diseases accompanied with an elevated temperature Infectious diseases On the contrary better use of antibiotic drugs in target tissues is reported Severe haemorrhagic diseases and radical anticoagulation treatment Systemic neurological diseases Active TBC Vegetative lability Hypersensitivity of patient and resistance to physical therapy with electric current and or electromagnetic fields Hypothalamic and hypophyseal disorders Hyperthyroidism Adrenal dysfunction adrenal hyperfunction Juvenile diabetes Systemic and or generalised mycoses Myasthenia gravis Autoimmunity diseases 2 7 2 2 Risks According to the current available knowledge of DE effects failure to meet the above mentioned contraindications minimal other residual risks of DE exist resulting from application of carrying electromagnetic fields and induced electric eddy currents Only the following information should be noted increase in the metabolic activity of treated tissues with all possible consequences up to a theoretical hypoxic damage sudden decrease in blood pressure during the procedure and shortly after the procedure and resulting transient dizziness and injury of the patient by falling Caution During the procedure t
83. trapezoidal course By sudden jump from the base lowest frequency to the maximum frequency which is applied for a certain amount of time and again by sudden jump from the maximum frequency to the original base frequency which is again applied for a certain amount of time In the course of procedure only 2 frequencies vary base the lowest Base and the maximum Base Swing schematically designed with a rectangle T L rectangular course Generally during electrotherapy with interference currents the triangular course of spectrum is the least radical the friendliest and at the same time it offers evenly all heterodyne interference frequencies applied in a particular therapeutic program The trapezoidal course of spectrum gives usually more radical effects and even though it provides all frequencies it offers in preference two therapeutic frequencies namely the base frequency and the maximum used frequency User s Manual VAS 07 BETTER FUTURE edition 44 The rectangular course of spectrum can generally be considered most radical It however provides only two therapeutic frequencies the base one the lowest and the maximum frequency Transition between them is realised in a jump way Important note It is the responsibility of a qualified physician to decide about the selection of pulse or interference currents for the treatment of a particular diagnosis and particular patient From the biophysical viewpoi
84. ts interference currents Pulse currents utilise the therapeutic effect of narrow low frequency electrical pulses ranging from one 1 Hz to several hundreds Hz whereas in the course of one procedure more frequencies can be combined in a sequential manner and this combination can be periodically repeated Interference currents utilise the therapeutic effect of low frequency shock waves developing by interference of two harmonic sinusoidally oscillating electromagnetic fields of medium frequencies around 5000 Hz whereas the low frequency shock waves can have frequencies from 1 to 400 Hz with the possibility of fluent frequency changes according to various therapeutic spectrums fast slow triangular trapezoidal and rectangular and with a fluently rotating vector of the electromagnetic field At the present time a generally known number of applications indications exist for the group of pulse and interference currents in the treatment of painful conditions to support healing regeneration and repair of the locomotor system tissues Specific frequency and time parameters are required for individual diagnoses For this reason one or more therapeutic pulse currents or one or more therapeutic interference currents can be allocated to individual diagnoses This allocation is made on the basis of generally available knowledge from technical literature professional communication generally acknowledged parameters of worldwide accepted el
85. tute of Public Health Prague University hospital of Faculty of Medicine of the Caroline University in Plzen Hospital in Pardubice Engineering Test Institute SZU Brno Industrial property administration of the CH Prague Embitron s r o Borska 55 301 00 Plzen Protocol MED 050060 30 01 2009 30 01 2012 audit MED 050060 30 01 2009 30 01 2012 audit No 8090010 30 01 2009 30 01 2012 audit 39 8174 E1 11 04 2008 39 8174 EMC1 11 04 2008 39 8174 E1 11 04 2008 EX 080057 C j 68 08 08 02 2008 27 03 2008 Examiner Prof MUDr Karel Koudela CSc 02 06 2008 Examiner Prim MUDr lvo J chym 02 06 2008 VAS 07 ed Better Future Embitron 25 03 2008 Distance electrotherapy Device 03 06 2008 VAS 07 edice Better Future 03 06 2008 61
86. ty electrically induced current produced 7 2 mV cm 0 5 A m at a specific conductivity of tissues 0 6 S m by the applicator in tissues maximum Pulse currents peak peak value of pulses preliminary values 1 5 mV cm 0 1 A m at a specific conductivity of tissues 0 6 S m Pulse width of excitation voltage 150 us or 340 us from frequency of 450 Hz only pulse width of 150 us frequency 1 1 200 Hz at pulse therapies up to 3 123 Hz Pulse induced electric currents randomised frequency 1 999 Hz Frequency of interferences 1 400 Hz Frequency of the 1 excitation coil 4 000 6 000 Hz harmonic Interference induced electric currents course Frequency of the 2 excitation coil 4 000 6 000 Hz harmonic course Wave length 660 nm Frequency 2 160 Hz ee Pulse width 3 ms 100 ms 24 or 40 LED 5 mm in diameter Luminous intensity 1 000 mcd water clear flaring angle 12 deg Linearly polarized emission Entire device assembly including packaging 14 5 kg Entire device assembly without packaging 12 5 kg Weight Instrument unit 2 kg Applicator 2 kg Applicator arm 1 5 kg Device assembly packaged 1400 x 800 x 800 mm Entire device assembly solo 1300 750 750 mm Dimensions Instrument unit 305 x 270 x 120 mm Applicator 205 x 145 x 70 mm Material of plastic casing ABS acrylnitrile butadien styrol and Plexiglas GS Surfaces of metallic parts Stainless komaxtit or ecological plastic
87. ully ruled out from operation of this device as well as from administration of procedures User s Manual VAS 07 BETTER FUTURE edition 6 e The device may be used only in a sufficiently stable position Falling of any part of the device must be effectively prevented Any handling with the device applicator may be performed only if the operating personnel hold the applicator firmly to prevent any undesirable movement Fixation bolts stabilising the applicator in a selected position must always be firmly tightened Special care must be taken to a vertical movement of the applicator with a carrying arm The released and unsecured applicator can slide down the guide pole and result in injury of Surrounding persons or its serious damage e tis necessary to check regularly the integrity of all device parts in particular electric cables and encapsulated part of the device e Noncoriginal parts must not be used as parts of the device no adjustment can be done except for those explicitly approved by the manufacturer e he device VAS 07 BETTER FUTURE edition is a medical device For that reason functional checks and safety checks must be performed on a regular basis These checks are required by relevant statutory provisions in all EU countries It is the responsibility of the user and responsible organisation to perform these checks These functional checks and safety checks may be performed only by the manufacturer of the device or by
88. vice was not used in accordance with the accompanying documentation User s Manual and in accordance with relevant statutory provisions regulations and standards The guarantee shall not be applied to any damage caused by incorrect or improper use of the device and damage caused by the operating personnel without proper qualification and or training in use of this device In addition the guarantee shall not relate to damages caused by fire water static electricity over voltage accident mechanical damage unprofessional interference with the device unprofessional installation discharged or flat accumulators or batteries as well as consequences of natural wear and tear and consequence of a force majeure event Other conditions for acknowledgement of this guarantee are specific for medical devices A medical device must undergo regular checks of functionality and safety periodic inspections These inspections may be performed only by exclusively authorised service care provider s A All service work on the device may be performed only by the authorised service care provider s From the viewpoint of legal requirements for complete traceability vigilance of medical devices the manufacturer of the device must know a final user of this device or relevant responsible organisation he medical device must be properly installed in the user s premises and operating personnel must be demonstrably trained EMBITRON s r o is
89. y be removed only by the manufacturer or subject authorised by the manufacturer to perform technical service Similarly no other person can disassembly repair modify or otherwise intervene with the device If this rule is violated the user of the device will loose the guarantee and there is also a risk of arbitrary injury and other damages e Prior to cleaning or disinfecting the device or any of its parts the device must be switched off and the detachable mains supply incoming mains cord must be disconnected from the power supply by withdrawal of a mains plug from the socket User s Manual VAS 07 BETTER FUTURE edition 7 e For cleaning and disinfecting it is necessary to use only safe and well proven cleaning and disinfecting agents and in no case admit ingress of any liquids into the device or any of its closed encapsulated parts instrument unit applicator e CAUTION Alcohol based agents must not be used for cleaning or disinfecting of any part of the device This caution is to be applied in particular on the emitting surface of the applicator made of cast Plexiglas It is also not allowed to use any abrasive cleaning agents or tools which would scratch surfaces e The device VAS 07 BETTER FUTURE edition similarly as with other usual electric instruments must not be operated in the vicinity of water sources such as bath tubs wash basin sinks swimming pools laundries humid basements and the like e Simila

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VAS – 07 &bdquo;BETTER FUTURE“ edition