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USER`S MANUAL EXTREMITER 2010

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1. Upper extremities Sudeck s syndrome lower extremities sauaye Jamo jo s1apiosip ameBug Akrocyan za With m Buergeri generally ystemic diseases n Vasoneuroses jo sesoJma8uoscA 5 8558 SO JAMO s a m en en e 5 cn en un c en a Grade 5 after Wagner Meggit Polyartheritis Lb PAN JO SOS NISC Sj8558A SALU J8MO 0 4 i Hi i 1 dE Diabetic claudications i iabet po iit palyneuopathy 01 lower limbs Obliterating atherosclerosis squn sadn 40 18 40 jo S18p10S1p euonpun z EF n al m 8 20 EXTREMITER 2010 BETTER FUTURE edition Group 2 Local circulatory disorders of extremities advanced sniiqnooq asoubeip UJIM Ul 591 4 torpid COMMON Subchronic Subacute torpid Uns 3j QM with oedema pue uns Without oedema with oedema Grade 5 alter without oedema with oedema Without oedema buiuuiDaq With oedema Without oedema With oedema 183n 290810 Without oedema with oedema Without oedema k 18911 1 With oedema 1
2. Rehabilitace a fyzik ln l ka stv 1 2001 str 18 32 Nakl dalov M Vakuum kompresivn terapie V ukov port l L ka sk fakulty University Palack ho Olomouc 2010 http mefanet upol cz weby Nakladalova Marie Profesionalni Onemocneni Hornich Koncetin prezen tace p4 pdf Kar skov K Urban J Vakuum kompresn terapie u senior s Ulcus Cruris Venosum Ill Nemocnice Milosrdnych bratr Vizovice a Katedra fyzioterapie Fakulty t l kultury University Palack ho Olomouc Absolventsk konference Katedry fyziologie Fakulty t lesn vychovy 18 19 6 2010 Kar skov K Efekt vakuum kompresn terapie u senior s Ulcus Cruris jako sou st komplexn terapie Magistersk diplomn pr ce Universita Palack ho Olomouc 2009 Pod bradsk J Va eka Fyzik ln terapie str 37 40 Grada Publishing Praha 1998 Pod bradsk J Pod bradsk R Fyzik ln terapie manu ly a algoritmy str 175 178 Grada Publishing Praha 2009 Guth A et al Lie ebn metody v rehabilit cii pre fyzioterapeutov str 43 47 Lie reh Bratislava 2004 Pitr K Pr cha J Z bran J Z hlava J Vacuum compression therapy Haemodynamic Therapeutic Rehabilitation Method in the light of Fine Yearsof Zesearch and Experience Physiotherapy Canada Official Journal of the Canadian Physiotherapy Association Kunc Z Vakuov kompresn l ba z pohledu rehabiliota n ho l ka e Rehabilitac
3. by alcohol free means means which do not leave colour traces or discolouration or damage of surfaces of the device by friendly application of disinfecting means It is always necessary to follow the recommendations and instructions of manufacturers of disinfecting agents The removed application cylinder 1 can also be sterilized Important notes During cleaning and disinfection of the device the device must be switched off by withdrawal of the mains plug from the mains ensured that any liquids or particles will not ingress into the inside of closed encapsulated parts of the device CAUTION The applied part of the device in particular the application cylinder 1 and sealing cuff 9 is not intended for contact with a non intact damaged or problematic and hypersensitive skin Note By special customer s request the application cylinder of the device can be equipped with other means increasing cleanness and comfort for administration of VCT procedures EXTREMITER 2010 BETTER FUTURE edition 67 The inlet of pressurization section of the application cylinder 1 see the insertion piece of pressurization 21a can be provided with a small vessel containing the HEPA High Efficiency Particulate Air filter which ensures filtration of air entering the application cylinder 1 and at the same time excess water vapours from the pressurization circle can condensate in this vessel whereas the water
4. 5 811 Without oe 5 Subchronic with oedema Without oedema With oedema 5 2 5 2 e J 2 ei z 5 jeuspy without oedema sme NN Without oedema NN objective problems Only subjective plaints With oedema moyin gt woRuynujew jo VON EISA JIUCUU quM pouad without oedema z 2 L je With oedema Without oedema beginning With oedema without oedema XX torpid pouad s1uoysgns beginning compta post trombotic post tra T iii snouaf EXTREMITER 2010 BETTER FUTURE edition 22 Group 3 Peripheral diabetic complications asoubeip UJIM 59100920 fter Wagner Meggit Grade 2 after Wagner Meggit sage Grade 1 after Wagner Meggit a Jamo j Grade 0 after Wagner Meggit e a e 5 zo e en en e Suoncopneya 3naqei EXTREMITER 2010 BETTER FUTURE edition Group 4 Neurological diabetic complications With oedema Without oedema with oedema asoubeip juawWaalbe without oedema With oedema beginnin
5. BETTER FUTURE edition If however the HARMONIZATION nature of procedure course is selected it means that the first cycle of procedure will start with ideally symmetrical values of positive pressure and negative pressure of 7 kPa and 7kPa The value of negative pressure will be however increased in each subsequent procedure and precisely in the middle of procedure duration i e in the 5th and 6th cycle you will achieve the required limit values of 7 kPa 11 kPa Then the value of negative pressure will be reduced in each subsequent procedure cycle and in the last 10th cycle the positive pressure and negative pressure will achieve symmetrical values and the procedure will be completed with these values This nature of the procedure is chosen if you want to achieve the predominance of negative pressure or positive pressure over the positive pressure or over the negative pressure given by the selected type of treatment but you want to achieve this in a very fine manner gradually and then in a single procedure you want to eliminate gradually and again in a very fine manner this asymmetry between the positive pressure and negative pressure This is appropriate in patients where the asymmetry of positive pressure negative pressure is therapeutically required but you want this action to come slowly during the procedure and to slowly disappear at the end of the procedure The IMPACT nature of procedure course means that the
6. s body Therefore it is necessary to keep clean all these parts of the device and to rule out the situation when these parts would become a source of any pathogens During the procedure clothing must usually be removed from the extremity However as we mentioned previously any bandages covering for example chronic skin ulcerations varicose ulcers are not to be removed during the VCT procedure in majority of cases In this manner significant contamination of the application cylinder is prevented and administration of procedure is simplified The therapeutic effect will not be influenced in any way Bandages are to be removed only if this can have a diagnostic importance for example objective assessment of possible bleeding from a wound or a defect on the extremity during the procedure The treated extremity can also be protected with a suitable protective coating If this coating is made from a micropore bag its role is only hygienically supportive Sterile sleeves usually from silicone are used only exceptionally If despite all the protective measures there is a contamination of attached or other part of the device and or it is necessary to disinfect the device before its using at the next patient disinfection of any part of the device can be made by the use of common disinfectants according to the Disinfection rules of a particular medical facility and or decision of a responsible physician medical professional but only
7. Clothing from certain types of fabric however may not prevent from sealing the extremity for example denim of stretch type In the positive pressure stage the extremity should get pale in the negative pressure stage the extremity should get red as a result of fresh blood supply These colour changes however may have be demonstrated in a very inconspicuous manner and they may appear after running more cycles of the procedure or even after administration of a number of procedures So if during vacuum compression therapy therapeutic effects are achieved also without visible expression of colour changes of the extremity the absence of these colour changes is not the cause for termination of therapy In majority of treated patients changes in colour are apparent In the negative pressure stage these changes would be observed in the most distal part of the extremity for example on a plantar side of the great toe Permanent absence of colour changes may be caused by improperly selected parameters of procedure such as the low value of negative pressure or more frequently short duration of this negative pressure However if in spite of changes in parameters of procedure you consistently observe that redness in the extremity in the negative pressure stage reaches in the distal direction only a certain level and it does not continue behind it this may be a manifestation of a demarcation zone separating the distal part of the extremity w
8. en efekt vakuov kompresn terapie pod van p stroje EXTREMITER firmy EMBITRON CZ prost ednictv m erytrocyt zna en ch radionuklidem 99m Tc Rehab A fyz l ka stv 3 1996 str 103 108 Pitr K Pr cha J Resl V Zahlava J Zabran J Vakuov kompresn terapie Hemodynamick metoda fyzik ln l by p t let v zkum a zku enost Rehabilitace a fyzik ln l ka stv 1 2001 str 18 32 Hrazdira Biofyzika U ebnice pro l ka sk fakulty Avicenum Praha 1983 Cordes J C Spezielle Physiotherapie in der Kardiologie Angiologie Broncho Pneuologie Rheumatologie und Chirurgie Traumatologie VEB Verlag Volk und Gesundheit Berlin 1980 Konferen n sd len v esk republice i v zahrani konzultace a osobn sd len informace a p sp vky poskytnut l ka i fyzioterapeuty klinicko hodnotitelsk mi pracovi ti stavy nemocnicemi l zn mi atpod na z klad v zkum i zku enost s VCT prov d nou p stroji EXTREMITER EXTREMITER 2010 BETTER FUTURE edition 35 3 Technical Description of the Device 3 1 Description of the Device Assembly The vacuum compression cylinder 1 which comes into contact with the patient s body is mounted on a design attractive supporting arch of shark fin type 2 and moved upwards and downwards along this arch by means of a remote controlled motor driven mechanism with a reliable and absolutely
9. is improved e Due to the drop of peripheral resistance the collateral blood supply development is supported e he higher arteriovenous pressure gradient increases the blood flow circulation in capillaries also during increased blood viscosity or reduced elasticity of erythrocytes e The increased venous return decreased peripheral venous pressure and increased capillary filtration contribute to a decrease in the thrombotic activity and improvement of lymphatic drainage of tissues e A physiological stimulation of the new formation of the capillary bed occurs including its functionality and performance possible utilisation of this method in patients with diabetic micro angiopathies EXTREMITER 2010 BETTER FUTURE edition 13 Vacuum compression therapy may be utilised as monotherapy but primarily it is an appropriate part of complex therapy It doesn t embody contraindications with administration of another forms of physical therapy Vacuum compression therapy shows a principal synergism with pharmacotherapy which is primarily based on the better induction and utilisation of medicinal products to target tissues Dietary measures and active movement if possible always belong to the basic conceptual framework of treatment A basic factor of vacuum compression therapy is the action of the closed hypobaric air environment upon the treated extremity The objective of this action is to induce a local passive hyperaemia from the most
10. of the graph are displayed the appropriate axes and its gauges for each measured quantity Each axe appertains to in color to measured quantity blue graph means the size of perfusion index PI red graph means the blood saturation with oxygen green graph means the volume change of the extremity black graph means the size of the healing pressure EXTREMITER 2010 BETTER FUTURE edition 17 The additional device for Simultaneous application of carbon dioxide to another improvement of better blood circulation As the accessory to the device Extremiter 2010 Better Future edition is possible to use the additional device CO2 Therapy see the User s manual The application cylinder is is filled not only with air but medical carbon dioxide is supplied into the cylinder in order to achieve the desired therapeutic concentration Carbon dioxide has a specific effect on capillaries and receptors This effect is especially valuable because it is transcutaneous and direct resorbed through the skin and its therapeutic effect is not necessary to mediate using often precariously functioning mediators of neural transmission Absorbed carbon dioxide opens functionally narrowed or closed capillaries releases precapillary sphincters shifts the oxyhemoglobin dissociation curve to the right and reduces blood viscosity VCT TREATMENT UNIT CONCENTRATION MEASUREMENT AND CONTROL CO2 GAS CONTROLLED INPUT On the general connec
11. BETTER FUTURE Czech republik European Union EMBITRON o o 0 ISO 13 485 2003 Ila in accordance with EU Council Directive 93 42 EEC SN EN 60 601 1 IEC 601 1 230 50 60 230 60 JEN 250 CO 2 x T 1 25 BF 30 IEC 60 529 M 2008 1 01 4 40 EXTREMITER 2010 BETTER FUTURE edition Manufacturing edition BETTER FUTURE edition Manufacturer s name EMBITRON s r o Borska 55 Plzen 301 00 Manufacturer s certification 00033 ISO 13 485 2003 Czech Republic European Union Electrotechnical classification Insulation class Health classification in accordance with the EU Council Directive 93 42 EEC Country of origin Electrotechnical standard used CSN EN 60 601 1 eq IEC 601 1 Determined power supply 230 V 50 Hz 60 Hz voltage Electric input 220W Enclosure of encapsulated parts IP 20 IEC 60 529 Type of applied part of device BF CSN EN 60
12. This mixing reservoir is equipped proper two HEPA filters and one metal rustless cylinder covered by efficient germicidal lamp which cares with the HEPA filters about the effective disinfection of the gasous medium air with CO2 with regard to the pacient with regard to the environment The device can be used without the carbon dioxide also to the effective disinfection of the recycling gaseous medium most often used in application cylinder of the device for vacuum compression therapy 2 7 2 Indications of Vacuum Compression Therapy Procedures It is the exclusive responsibility of a qualified physician to decide about the administration of therapeutic VCT procedures and selected program or parameters of procedure for the treatment of a particular diagnosis and particular patient The following data were approved in the process of clinical evaluation of the device however they have only a supportive and information nature The pre programmed parameters of these procedures are preliminary only and if used with a particular patient their verification by a physician is necessary along with subsequent monitoring of patient s response to the given therapy see the information in previous chapter EXTREMITER 2010 BETTER FUTURE edition 19 2 2 1 Procedures indicated according to diagnoses Group 1 Peripheral vessel disorders Upper extremities uongjna3 saposip neus lower extremities
13. VCT It is possible because of the objective and valid exact measurement extremity volume monitoring V vascularisation and arterial blood oxygen saturation monitoring SpO2 perfusion index PI Prescription monitoring and evaluation of VCT results may be carried out only by an experienced and responsible physician VCT procedures may be carried out by trained health service personnel or by physiotherapists Utilisation of VCT for reconditioning sports and cosmetic purposes can be done only in co operation with a physician Fundamentals for the use of negative pressure positive pressure stages during VCT ensue from physiology of their effects A higher value of deep hyperemising negative pressure is to be selected for arterial circulatory disorders and their stagnant metabolism Values of positive pressure must be able to ensure corresponding venous drainage In the case of combined arterial and venous disorders it is advisable to increase the value of positive pressure on an individual basis This value however must not exceed the negative pressure With dominative oedema of venous or lymphatic origin the positive pressure can be set up up to the double value of negative pressure The negative pressure phase must be longer than the positive pressure phase In most cases it is possible to choose the prescript for VCT procedure from the software of the Extremiter device With a view to this is in the device pre progr
14. VCT contraindications e Acute conditions of venous thrombosis and embolism and suspicion of them e Aneurysm in the area of the treated extremity a risk of microembolism from the local thrombus e Severe haemorrhagic diseases and radical anticoagulation treatment e Acute open wounds with a risk of bleeding and development of subcutaneous emphysema e Local septic infections with a risk of dissemination of infectious agents and toxic products e Local malignant tumours in cases of existing risks of dissemination of tumour metastases e Advanced necrosis gangrene with a risk of toxic decomposition substance mobilisation into the circulation e Oedemas of extremities with a cardiac origin e Leyden syndrome e Gravidity relative contraindication can be taken into consideration in treatment of lower extremities primarily in more advanced stages of gravidity e Increased trend to petechias and haematomas at the place of hermetic sealing of the extremity pressure induced by the sealing cuff or neck edge of the application cylinder e Psychical disorders not allowing closure of the extremity in the applicator On principle of any therapeutic method the above mentioned contraindications list cannot be considered exhaustive The patient s overall condition must also be taken into consideration For example universal arteriosclerosis a stage of the ischemic heart disease serious disorders of the myocardium due to other reasons s
15. condensate can be released from the vessel after releasing a particular valve in the bottom of the vessel The valve must be closed again after this action The vessel can also be screwed out cleaned up and dried up A particular filter can also be replaced at the removed vessel In addition to the above described filtration and condensation vessel another vessel can be integrated filled with a suitable solution whose vapours do not damage materials from which the application cylinder is made Plexiglas as well as other HVAC elements stainless polyethylene polyurethane and the like Vapours of this solution should have auxiliary disinfection effects and they act as nice fragrance agents During pressurization of the application cylinder this solution is suctioned on the principle of airbrush and ultra fine drops of solution fill with very fine aerosol particles the area of the application cylinder and entire pneumatic circle of the device and subsequently after opening the cylinder also environment of the patient s device Another filtration and condensation vessel can be placed at the vacuum exit from the application cylinder 1 see the insertion piece of vacuum application 21b A relevant filter in this vessel ensures a certain rate of filtration of air leaving the application cylinder 1 during the procedure Air suction and air exhaust into the atmosphere is always provided with standard filters inside the device While a
16. of a disease diabetes mellitus angiopathy trophic EXTREMITER 2010 BETTER FUTURE edition 5 disorders degenerative disorder of the movement system or a trauma As well is not possible to ensure the stimulation of the rise and progress of colaterals From a technical point of view the device EXTREMITER 2010 BETTER FUTURE edition where the therapeutic application cylinder 1 is made from perfectly transparent cast Plexiglas GR with a technologically ensured elimination of internal stress of materials This solution ensures high safety of the applicator and its long term service life without changes in decisive properties and the ideal possibility to observe visual colour changes in an extremity during the procedure In particular it is possible to observe required therapeutic hyperaemia which occurs in the under pressure phase and it would reach up to acral parts of the extremity or to observe changes in a surfaces venous bed In case trofic defects or chronical consequences of traumas is possible while using the VCT procedure watch the conditionswith the intensity for example if the defect appears to bleeding In other ways the extremity with defects will be usually putted into the application cylinder the defects are properly procure with the sterile protection Vertical positioning of the application cylinder 1 and its required tilting is motor operated and remote controlled Putting the application cylinder 1 on t
17. of mains supply plug connector network the cord 26 In the cord block there is a power supply switch 2 fuses T 1 25 A as well as device label near the cord 26 Detachable mains supply mains cord 2 Sealing of the application cylinder bottom o rings 28 Application position chair with removable sides and possibility of moving of the pacient left right 29 neoprene inlay intended for putting between the pacient s extremity and the sealing cuff 30 Stand for the material of VCT All functional components of the Extremiter device 2010 Better Future edition are placed on the robust construction made from exact laser thick walled iron plate slops which are connected by welding and screwing Some of the exact parts are sharpened Complicated components are tooled by paring and turning on modern CNC machines There is used bearings with long lifetime Plastic function parts are made from highly abrasion resistance plastics for example the type Murtfeld Metalic inside parts are provided by colour adjustment komaxtit The parts which can t be adjust by this way are external zinced chromed or it is used by stainless steel Because of using of these technologies the lifetime the reliabilty and the construction maturity of the device are maximal 3 2 Legends on the Device 2010
18. opened collateral bed including fully utilised and strengthened collaterals Significant improvement of perfusion and increased presence of arterial blood in the extremity have also been demonstrated experimentally using a gamma camera by means of Tc radionuclide labelled erythrocytes It has been shown that during the VCT procedure perfusion was increased approximately 3 times in the negative pressure stage and 2 times in the positive pressure stage of vacuum compression therapy Fig 2 2 Aktivita radionuklidu Tc proporcion ln INTENZITA PROKRVEN DK 3500 3000 2500 2000 L en kon etina 1500 1000 Pretlak Podtlak lt e pen ui 4 o E r 2 N L E m un e c 5 Fig 2 2 Change in perfusion of the treated and untreated extremity during atypical application of VCT The effect of increased amount of arterial blood in the extremity also remains for a long time following the procedure namely with an approximately 40 increment Fig 2 3 Changes in perfusion of the extremity are also visible on its surface layers This fact is very important when VCT is used in the treatment of skin defects such as varicose ulcers or diabetic ulcerations but also in cosmetic anti aging etc This fact has experimentally been confirmed by using the in vivo remission spectroscopy diagnostic method Fig 2 4 Vacuum compression therapy may also be considered
19. solid elbow and head rests if possible It is very important that the armchair enables a movement to the left and right because only by this way it is possible to insert the treated extremity exactly to the centre of the application cylinder VCT 16 EXTREMITER 2010 BETTER FUTURE edition procedures can also be administered to the patient in lying position on bed or couch In doing so it is necessary to ensure carefully the patient s stable position prevent his her falling from the bed in the course of treatment Prima facie evidence of VCT efficiency using the EXTREMITER is increased by a device enabling variable pressure changes in the sealing cuff of the device The necessary pressure in the sealing cuff ensuring a hermetic seal of the treated extremity is controlled fully automatically with a feedback The optimum sealing pressure follows dynamically pressure changes in the application cylinder Therefore the treated extremity is not strangulated by the cuff As every really effective therapy vacuum compression therapy has some risks and contraindications Its prescription may be given only by a physician A typical prescription of VCT must contain a localisation of a treated part of the body negative positive pressure values duration of maximum pressure phases or identification of therapeutic program patients position during treatment sitting supine procedure duration total number of procedures in a series number of ther
20. stanf for material sealing cuffs etc 5 The additional arrangements to the device Extremiter 2010 Better Future edition 5 1 CO2 Therapy Better Future The simultaneous application of carbon dioxide along with the ongoing therapeutic procedure of vacuum compression therapy is a very useful combination of physical and therapeutical biochemical effects To achieve these therapeutic effects the Extremiter should be complemented with a special electonically controlled mixing and filtration equipment and necessary technology for the distribution of EXTREMITER 2010 BETTER FUTURE edition 71 medical gases as well as appropriate technology for effective disinfection of gaseous medicine media and CO2 recycling This solution ensures the medically desired concentration of CO2 in the applicationcylinder of the Extremiter device and extremely low gas consumption while maintaining high safety standards of patients and operators 5 2 Pacient s monitoring Patients diagnostics monitoring in real time and during the procedure enables treatment results objectivisation as well as feedback impedance controll of the procedure which is important for maximal treatment effects For extremity volume changes monitoring for vascularisation and arterial blood oxygen saturation monitoring 5 3 PC Supervision It is a Supervising PC laptop with monitoring and control SW The supervising PC is an instrument for a doctor or head physical therapist on h
21. test the travel with the entire device and brake release brake application of relevant travelling wheels If you already managed the technique of travel with the entire device and chair and positioning of the application cylinder 1 you can proceed to opening and hermetic closing the cylinder After unscrewing and removing four fixation handles 17 remove the cylinder bottom 27 Draw the bottom out carefully in the direction of cylinder axis If the insertion pieces of hoses 21a 21b remain connected place the cylinder bottom 27 in such a way to prevent from damage of these hoses The opened bottom will enable to clean and disinfect perfectly the internal area of the application cylinder 1 or to handle the distal part of the patient s extremity during insertion of the extremity into the application cylinder 1 padding the extremity or placing various diagnostic sensors of biologic magnitudes on the treated extremity During reclosing the cylinder bottom 27 first you must check for the integrity of circular sealing and its uniform and perfect insertion in a particular groove If these requirements are not met position of silicone sealing must be adjusted or this sealing must be replaced The cylinder bottom 27 is to be attached to the cylinder in the direction of cylinder axis 1 and carefully screwed using four fixation handles 17 The handles are to be uniformly and adequately tightened Circular sealing must sit down uniquely a
22. the device if such data are not deleted purposely In the case of a qualifying requirement and in compliance with the relevant legal provisions remote entry to the control computer may be performed via the internet This option can be used for remote technical service as well as for the purposes of a promising telemedical approach in physical therapy and diagnostics 4 7 Cleaning and Disinfection The entire device assembly should be kept clean and effectively prevented its excessive pollution of contamination If the device is not used for a longer 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 humidified with water or a friendly cleaning agent Never use alcohol based cleaning agents or abrasive means For 66 EXTREMITER 2010 BETTER FUTURE edition polishing or renewal of Plexiglas of the application cylinder the manufacturer of PLEXIGLAS GS recommends special means Important note Alcohol based cleaning agents or abrasive means must never be used for cleaning of the device or its parts Applied parts of this device the application cylinder 1 manufactured from annealed Plexiglas PMMA and sealing cuff 9 manufactured from medically safe rubber resp auxiliary neoprene rings can get in contact with the patient
23. you will end with required asymmetrical pressure values for example 7 kPa 11 kPa This means that the asymmetry effect of acting positive pressure negative pressure is marked at the end of procedure This is appropriate in patients where the asymmetry of positive pressure negative pressure is therapeutically required but you want this action to slowly appear during the procedure In this manner for example in patient with ischemia of extremity and at the same time very sensitive to a therapeutic under pressure action you will try to achieve the best results of treatment at the most possible sensitive approach The COMPENSATED nature of procedure applies an impact nature in the first half of procedure but in the second half of procedure this nature is completely overturned compensated in the meantime acting asymmetry In our illustrative example the procedure is started in its 1st cycle with the values of 7 kPa 11 kPa type of treatment 4 This asymmetry is reduced in each subsequent cycle and precisely in the middle of procedure duration in the 5th and 6th cycle you will achieve the symmetrical values of 7 kPa 7 kPa Then from the 7th cycle of procedure the type of treatment will be changed and in our illustrative example you will act with the predominance of positive pressure and at the end of procedure in the last cycle you will end with the following values positive pressure 11 kPa negative pressur
24. 6 4 2 4 Well Proven Procedures 7 4 2 5 Procedures According to Users 58 4 2 6 Prescription 61 4 2 Termination of Control Software Running 61 4 3 Preparing the Device and the Patient for Procedure Administration 63 4 4 Administration of Vacuum Compression Therapy Procedure 65 4 5 Completion of Vacuum Compression Therapy Procedure 65 4 6 Operation of the Device in a technical Service Calibration and Control Mode 66 4 Cleaning and Disinfection 66 4 8 Maintenance 68 4 9 Regular Functional and Safety Checks of the Device 69 4 10 Environmental Protection and Disposal of the Device 69 4 11 Packaging 70 4 12 The operation conditions and storage 70 4 13 Transport 70 4 14 Parts of the device and expendable supplies 70 5 The additional arrangements to the device Extremiter 2010 Better Future 71 5 1 CO2 Therapy Better Future 71 5 2 Pacient s monitoring 72 5 3 PC Supervision 72 2 EXTREMITER 2010 BETTER FUTURE edition 1 Intended Use and Basic Description of the Device The purpose of the device EXTREMITER 2010 BETTER FUTURE edition is to administer physiotherapeutic vacuum compression therapy hereinafter also referred to as VCT with the aim of favourable influencing organic and functional peripheral capillary return disorders stagnant metabolism and impaired trophism extremities of vascular post traumatic systemic primarily diabetic neurocirculatory degenerative and stress ae
25. 601 1 eq IEC 601 1 Serial number The device is able to produce the positive Warning pressure up to 25 kPa and negative pressure up to 25 kPa Fuses at electrical input of 2 2xT18A L20V 000000 T 1 2xT18A L20V 000000 A L250V supply Obligatory reference to the Product Documentation Temperature range 10 C 40 C 5 C 50 C operation storage Maximum humidity 75 75 operation storage 4 Operation of the Device EXTREMITER 2010 BETTER FUTURE Edition 4 1 Installation of the Device and Testing its Mechanical Parts The device EXTREMITER 2010 BETTER FUTURE edition is installed in a simply way However the device should be installed by a aualified expert trained and authorized by the manufacturer If the device was delivered in a transport case side walls and top wall of the case must be removed first The procedure for taking the device out of the transport case is illustrated with pictures located directly on the case In doing so the shipping case must not be opened using excessive force Removable walls and top wall are bolted and the bolts must be unscrewed preferably using a cordless screwdriver Then the device assembly is to be gradually taken out and individual components are to be carefully unpacked First smaller and lighter parts are taken out such as sealing cuffs 9 supporting 18 and closing 19 EXTREMITER 2010 BETTER FUTURE edition 41 circular rings
26. USER S MANUAL EXTREMITER 2010 CONSTRUCTIONAL AND DESIGN MODIFICATION BETTER FUTURE edition TABLE OF CONTENTS 1 Intended Use and Basic Description of the Device 3 2 General IntormattOn end ta sce env de usui Dea rog P deu CES 8 2 1 Device Manufacturer 8 2 2 Authorised Distributor and Service 8 2 3 Purpose of the User s Manual 8 2 4 Guarantees 8 25 Safety Instructions 9 2 6 Technical Characteristics of the Device EXTREMITER 2010 BETTER FUTURE Edition 12 2 7 Indications Contraindications of Vacuum Compression Therapy 13 2 1 Administration of Vacuum Compression Therapy Procedures 13 2 2 Indications of Vacuum Compression Therapy Procedures 19 2 2 1 Procedures indicated according to diagnoses 20 2 2 2 Procedures indicated according to formerly exclusively used well proven procedures 30 2 7 3 Contraindications of Vacuum Compression Procedures 31 2 4 Examples of References 31 3 Technical Description of the Devi ce 36 3 1 Description of the Device Assembly 36 3 2 Legends on the Device 40 4 Operation of the Device EXTREMITER 2010 BETTER FUTURE Edition 41 4 1 Installation of the Device and Testing its Mechanical Parts 41 4 2 Administration of Vacuum Compression Therapy Procedures by Means of Control Computer 45 4 2 1 Introduction 45 4 2 2 Procedures According to Diagnoses 46 4 2 3 Favourite Procedures o
27. a 7 kPa Numeric values are immediately displayed in the relevant fields and vertical stripes will appear on both sides of the display The height of the right strip in blue indicating exposure to the venous system is proportional to the selected value of positive pressure The height of the left strip in red indicating exposure to the arterial system is proportional to the selected value of negative pressure Then in the second row on the device display select the type of treatment such as 4 kPa which means that the applied negative pressure will be reduced by other 4 kPa vacuum of 11 kPa will be applied In addition you will select a so called Nature of Procedure This is a parameter which covers pressure parameters the positive negative pressure ratio developing throughout one procedure not just one cycle The CONSTANT nature of the procedure course means that in each cycle of the procedure the value of maximum positive pressure a so called positive pressure plateau and the value of the maximum negative pressure a so called negative pressure plateau is still the same If for example the procedure with the maximum positive pressure of 7 kPa and maximum negative pressure of 11 kPa is selected these values will be achieved always constantly in each cycle If for example 10 cycles periods will be administered in a procedure the value of 7 kPa 11 kPa will be achieved in each cycle 58 EXTREMITER 2010
28. a sk konference p i p le itosti veletrhu zdravotnick techniky Arab Health Dubai U A E 28 1 2 2 2008 Koudela K Pitr K Pr cha J M en zm n perfuzniho indexu pri vakuov kompresivn terapii XV sjezd Spole nosti rehabilita n a fyzik ln medic ny CLS JEP Luha ovice 16 17 5 2008 Pr cha J Biofyzik ln experimenty objektivizuj c innost vakuov kompresn terapie p i l b c vn ch onemocn n kon etin Odborn semin Spole nosti pro rehabilita n a fyzik ln medic nu CLS JEP Brno 9 10 10 2009 Pod bradsky J Va eka Fyzik ln terapie I Il Grada Publishing Praha 1998 Calta J Mach lek Z Vacek J Z klady fyzik ln terapie pro praxi Reforum Praha kv ten 1994 34 EXTREMITER 2010 BETTER FUTURE edition Krause D Dittmar K Ergebnisse bei der physikalischen Therapie peripherer arterieller Durchblutungstorungen Munchener Medizinische Wochenschrift Vol 116 No 8 p 385 Munich 1984 Pitr Zahlava J Pr cha J The Experimental Verification of Vacuum Compression Therapy Effects with Treatment by device Extremiter Konferen n pr sp vek Dusseldorf 1997 Hrd R Choroby perifern ch tepen mo nosti prevence a l by z pohledu rehabilita n ho l ka e Praktick l ka Vol 78 1998 No 1 pp 33 35 Pitr Zahlava J Pr cha J Experiment ln ov
29. able for the treatment of peripheral arterial circulatory disorders of extremities arterial disorders 2 Procedures suitable for the treatment of conjoint peripheral arterial circulatory disorders of extremities and disorders of venous blood and lymph drainage 3 Procedures for the treatment of extremities with oedemas Especially for venous troubles Each subgroup subfolder contains 10 pre programmed procedures with a gradually increased intensity The procedure of standard intensity is always sharpened The folder Procedures According to Diagnoses includes approximately 500 therapeutic procedures with very carefully pre programmed parameters These therapeutic procedures are divided into 12 basic groups which are further subsequently hierarchically divided so it is very easy and quick to search a particular procedure with necessary parameters for the patient with a particular diagnosis The basic diagnostic groups for indication of VCT are as follows Peripheral vessel disorders Local circulatory disorders of extremities Peripheral diabetic complications Neurological applications of vacuum compression therapy Musculoskeletal disorders of extremities with an expected therapeutical effect of improved profusion and trophism of tissues e Vertebrogenous algic syndromes with projections to the upper extremity or lower extremity e Oedematous conditions e Post traumatic and post surgery conditions e Bone disorders of extrem
30. ain amount of time the running procedure will spontaneously change to newly selected values of positive negative pressure In our illustrative example this regards the transition from values 8 kPa 6 kPa to values 6 kPa 5 kPa There are two other buttons on the bottom ledge THERAPY and SAVE The button THERAPY enables to verify during the procedure which of the procedure is administrated see the following figure The button SAVE could be used after the end of the procedure By the pushing of this button is possible to save the identification of the pacient subjective and objective evaluation of the procedure The datas are saved into the complete database of the pacients The identificated procedure is possible to choose anytime from the folder Favourite Procedure We confirm the requierement for the saving of the parametres And to the marked stripes we write requiered datas For the possibility of writing we open the helping keybord we press the button KEYBORD We will confirm the written datas and go back to the running of the procedure Notice For data writing is possible to use the external keybord also There are USB ports for the connection of external keybord or mouse 4 2 3 Favourite Procedures All parameters of the running procedure can be saved during the procedure in the folder Favourite Procedures To save these parameters press the SAVE button Confirm the request for saving parameters of th
31. ammed the folder Procedures according to Diagnoses This folder contains cca 500 procedures of VCT they are classified according to indicated diagnoses That means that the folder is a very exact and well arranged list encyclopedia EXTREMITER 2010 BETTER FUTURE edition 15 The reaction of the pacient on the administrated procedure can be very individual and untypically it can diverse on each sitting As it is in the folder Procedures according to Diagnoses preprogrammed and hierarchic classified 500 procedures with very proper parametres these are based on the 20 years of researching of VCT the procedure can t be the most optimal for each pacient and each situations The best solution is to use all additional devices above all the Pacient monitoring This addition enables to watch each reaction of the pacient while using the VCT In setting the appropriate time parameters periods of duration for both phases positive pressure negative pressure it is advisable to take a reverse ratio of maximum pressure values of these phases for rough orientation This means how many times the absolute value of negative pressure in kPa is higher lower than the absolute value of positive pressure so many times the duration of this phase will be shorter longer Note As duration in seconds is understood the time for which the maximum set up pressure phase value is held and it does not mean the period that is necessary for
32. and patients extremity the neoprene inlay which further increasees the sealing pressure to the extremity and helps to optimalize the procedure can be sling These inlays are made in the set of 12 sizes For the operative and effective working is necessary to have a stand for the material This stand was very properly developed like a essential but and needed part of the system for VCT administration The stand is made from easily desinfectioned and attractive stainless steel The stand occupies minimally space hereat provides the pssibility of well arranged sealing cuffs and annulus positioning at first hand reach of the physiotherapeutists EXTREMITER 2010 BETTER FUTURE edition 37 28A 38 EXTREMITER 2010 BETTER FUTURE edition Fig 3 1 General view of the EXTREMITER 2010 BETTER FUTURE edition and description of the main parts of the device assembly Legend O9 ee 17 18 19 20 21 22 23 Hyperbaric hypobaric application cylinder Vertical supporting arch of a shark fin type Device base Separate linear guide travel and horizontal beam cross member of the application cylinder Dual type handle intended for locking the separate linear guide horizontal movement of the application cylinder Mechanical turn mechanism intended for tilting of the application cylinder 1 Arms Supporting arms 7b Closing arms Neck of the application cylinder 1 Inflata
33. apeutic series in a year and the like When administering VCT procedures the clinical view is necessary Therefore it is necessary to individualise therapeutic parameters also during treatment according to the patient s actual condition For this purpose is optimal to use the additional device type Pacient monitoring its meaning was described above In case the doctor working at another working place want to use the control diagnostic system there is a possibility to use the another additional device type designation PC supervision It is a optional additional device of the device for vacuum compression therapy Extremiter 2010 Better Future edition which enables to create such as model of the device which provides the possibility of control evidence and controling of the procedures by the help of distant PC interconnect wireless or interconnect with the control PC The base of the technical solution of this additional device PC supervision is the securing of the communication between the device s control PC and the supervising PC which provides to the doctor or to another medical worker the possibility to control and file the administrated procedure of VCT By this way will be the quality the efficiency the suitability and l st but not least the safety of the administration of VCT The additional device type PC supervision provides to the medical worker to watch the process of the VCT the reaction of the pacient in real time The docto
34. as passive vascular training in contrast to active training therapeutic physical training and movement regimen Vacuum compression therapy can also be applied as a highly effective and decisive complement to such active training VCT undertakes the key role in cases of other serious disorders and polymorbidity which restrain or exclude the possibility of active movement therapy During VCT adequate changes in skin colour of the treated extremity are usually visible synchronously with the alteration of positive pressure and negative pressure phases see illustrative Fig 1 3 and 1 4 In the negative pressure phase the colour of the skin becomes hyperaemic purple This coloration spreads in the distal direction down to the tips of the fingers If during this negative pressure stage the generalisation of redness of the extremity is not achieved up to the acrum it is recommended to prolong the duration of this negative pressure stage and subsequently to increase the negative pressure After a given number of negative pressure positive pressure cycles the purple colour usually turns to clear red Demonstrations of these colour changes are usually very subtle therefore it is necessary to monitor them carefully through the transparent wall of the application cylinder during the procedure The described course of skin colour changes is so far an essential indicator of therapy efficiency during the procedure If a clearly red marking of the skin i
35. ation is a decrease in peripheral resistance along with a decrease in intra arterial pressure distally from the closure Vacuum compression therapy VCT is based on the alternation of negative pressure and positive pressure phases Fig 2 1 also Fig 1 3 and 1 4 In the negative pressure phase the extravasal pressure is reduced and filtration of gases and substances into the tissues is increased The secondary drop of intravasal pressure stimulates the collateral circulation as well as perfusion In the positive pressure phase the content of blood in the venous system is expelled and the arteriovenous pressure gradient in the capillary section is improved This again results in an increase in perfusion and absorption of fluid from tissues At the same time the volume of venous blood is reduced the thrombotic activity is decreased and lymphatic drainage is accelerated This fact indicates that the positive pressure phase should be used for a long time during treatment of chronic venous insufficiency as well as for some lymphatic oedemas Of principle for the treatment of circulatory disorders is the controlled vacuum phase but it is periodically alternated by the effective compression phase When setting up the parameters of the positive pressure stage it is necessary to take into consideration the fact that the blood volume respectively mobilised tissue liquids displaced from the peripheral tissues may adversely exert the weakened heart o
36. aution Even if the parameters of pre programmed procedure are modified the recommended technical and application parameters will remain unchanged If you accept the parameters of pre programmed procedure simply press the START button If you do so the therapeutic procedure will be started If necessary however you can modify the pre programmed parameters For this purpose first you must press and hold down the button with a lock symbol Unlocking this imaginary lock will allow you to modify the parameters of the procedure For example a 30 minute procedure involving approximately 16 vacuum compression cycles periods will be modified to a procedure with a firmly selected 10 cycles periods which will take about 18 minutes By pressing the START button you will initiate the procedure 50 EXTREMITER 2010 BETTER FUTURE edition Upozorn ni V t snic man et do lo k n hl mu sn en tlaku procedura ukon en zkontrolovat podm nky pod v n procedury In case we are using the control SW which is intended to other additional possibilities the start will be little complicated After the setting up of the procedure parametres and after the pressing START button you will be questioned to the measuring of the starting position of the treated extremity You will confirm it by the OK button By the press of the OK button the process will be started This last cca 15 seconds and the time of this process is
37. ble sealing cuff Removable bottom of the application cylinder 1 Remote control of travels and positioning of the application cylinder 1 Motor driven height adjustment of the application cylinder 1 tilt of the application cylinder 1 and brake application brake release of the supporting arch movement 2 11a Motor driven feed of the application cylinder 1 along the supporting arch 2 in the upward UP direction 11b Motor driven feed of the application cylinder 1 along the supporting arch 2 in the downward DOWN direction 11aa Movement of the supporting arch 2 brake released ON 11bb Movement of the supporting arch 2 brake released OFF 11aaa Motor driven tilting of the application cylinder neck 1 the upward direction UP 11bbb Motor driven tilting of the application cylinder neck 1 in the downward direction DOWN Control computer box with a control and display unit control computer Touch screen of the control and actuating computer Travelling wheels with freely turnable horizontal pins and brakes 14a Supporting arch travel holder 2 resp entire device travel also used as arm rest when working with the touch screen Application cylinder travel holder 1 in the direction of cylinder axis also used for lifting off the closing arms 7b after release of the fixation handles 24a 24b in removal of the cylinder 1 Fixation handles 4 pcs used for release and removal of
38. by one step you will find yourselves at field 10 7 kPa On the contrary decrease in power of action of procedure can be achieved after moving in a diagonal direction to the left upwards in moving by one step you will find yourselves at field 6 5 kPa These described movements are significant because the sense orientation of therapeutic procedure given by combination of positive pressure and negative pressure will not be changed From a particular field however you can move in other directions too in movements horizontally to the right to the left you will maintain the type of treatment but you will change the intensity of action in movements vertically upwards downwards you Will maintain the intensity of action but you will change the type of treatment In movements in the diagonally opposite direction downwards to the left upwards to the right you will maintain the size of negative pressure and you will change only the size of positive pressure On the contrary for the upper part of the table with prevailing positive pressure over negative pressure we can say that an increase in power of action of procedure can be achieved after moving in a diagonal direction right up in moving by one step you will find yourselves for example from field 8 6 kPa on field 10 7 kPa On the contrary a decrease in power of action of procedure can be achieved after moving in a diagonal direction to the left downwards i
39. ck spole nost a esk radiobiologick spole nost LS JEP Ro nov pod Radho t m 2001 Pr cha J Pitr K Z hlava J Z bran J P strojov metody fyzik ln l by poruch prokrven a zhor en trofiky kon etin Angiologick sympozium Praha 2001 Tomanov J Resl V Pr cha J Nov fyzik ln l ebn metody u pacient s lymfoven zn isuficienc Flebologick dny konferen n p sp vek esk Krumlov 2002 Pr cha J Pitr K r mek B Syst mov hemodynamika v rehabilita n a rekondi n praxi P edn ka odborn ho programu X sjezdu Spole nosti rehabilita n a fyzik ln medic ny Luha ovice 2003 Pr cha J N kter biofyzik ln pozn mky k vakuov kompresn terapii Semin Syst mov a perifern hemodynamika a jej role v l ebn rehabilitaci P erov 2003 Pr cha J Pitr K Uplatn n operativn diagnostiky hemodynamiky p i pod v n n kter ch fyzik ln l ebn ch procedur XVII zjazd OS FBLR Bojnice Slovensk republika 14 15 6 2007 tvrtinov V Prekopov E Bo ek L Matou ek P Mickov M Pitr K Tomanov J Resl V Pr cha J Uplatn n operativn diagnostiky hemodynamiky p i pod v n n kter ch fyzik ln l ebn ch procedur Semin Il intern kliniky LF UK v Bratislav Slovensk republika 31 1 2007 Pr cha J New application possibilities of vacuum compression therapy L k
40. ctly and reliably interpret anamnestic and diagnostic factors leading to an effective purposeful and safe application of vacuum compression therapy 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 technical progress medical legislation and medical ethics The patient client must be monitored in during the administration of procedure and after its finishing and based on the patient s reaction to VAC procedures an original therapeutic decision must be re assessed if necessary 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 The user of the device EXTREMITER 2010 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 network and subsequent calling a professional repair service without undue d
41. d for cleaning or disinfecting of any part of the device This caution is to be applied in particular for the cylinder applicator made of cast Plexiglas It is not allowed to use any abrasive cleaning agents or tools which would scratch surfaces e he device EXTREMITER 2010 BETTER FUTURE edition similarly as other similar 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 he detachable mains supply incoming mains cord of the device EXTREMITER 2010 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 EXTREMITER 2010 BETTER FUTURE edition must be immediately 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 e the detachable mains supply incoming mains cord is damaged or worn out e the device is exposed to action of water or other liquid which would leak inside the unit e 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 e the device was damaged by fall or impact e the dev
42. dic inspection regular functional and safety checks the authorised service performs prescribed maintenance actions of electric medical devices as well as measurement of positive pressures and other decisive physical quantities In doing so the device is to be recalibrated on a regular basis If parts of the device exposed to pressure are regarded pressure vessels according to local regulations in force it must be carried out their inspection and measurement consumables must be replaced and completed and worn operational components must be replaced In any problems are found necessary repair work must be performed The user of this device is informed about all new facts ascertained regarding the operation of this device 4 10 Environmental Protection and Disposal of the Device The device EXTREMITER 2010 BETTER FUTURE edition does not have any direct negative impact on the living environment From the viewpoint of applied pressures it is only necessary to ensure protection from their undesirable effects max 25 kPa in the volume of appr 70 litres The device under operation has a small power take off max 220 VA After the elapse of its life time and putting the device out of operation it must not be disposed of as municipal waste but it must be dismounted to individual components as outlined below metal parts structural steel stainless steel non ferrous metals plastic parts Plexiglas fibreglass polyethylene hos
43. ding on the time of the current procedure The propagation time of procedure is shown under the dynamically changing graph Depending on the pressure units selected in the previous menu pre start table the value of pressure is displayed in kPa or mmHg To the right from the graph there are two pictures representing the upper and lower treated extremities with a schematic display of vascular bed including the changing condition of venous valves During the procedure the pictures and diagrams are animated depending on the alternation of negative pressure and positive pressure phases In the positive pressure phase the extremity gets pale and reduces its volume because the venous blood is expelled On the chart this fact is reflected in reducing the volume of venous bed blue and narrowing the veins with a smaller flow of arterial blood into the extremity red In the negative pressure phase fresh arterial blood red is suctioned into the extremity the extremity changes its colour to red but its volume is increased including the volume of vein bed and dilatation of veins These actions are cyclically repeated Medically qualified operating personnel should be able in accordance with the schematic diagrams to observe these changes also directly on the patient s extremity and depending on it to modify the parameters of procedure Under the graphs and charts there is a zone intended for listing and reporting errors which may be gen
44. dministration Testing and verifying possibilities to control the process of vacuum compression therapy can be carried out with a blind neck of the application cylinder 1 using an appropriate seal cover which is usually supplied with the device Then you can proceed with the administration of vacuum compression therapy procedures to a proband or patient in accordance with the relevant indications and contraindications The device is turned off travelling wheels 14 are secured with brakes in applied positions The closing circular rings 19 at the external part of the neck 8 of the application cylinder 1 are to be gripped at the point of diagonally placed metal pegs turned with them so that three circular cut outs along its periphery are precisely above the circular heads of securing bolts fixed in the Plexiglas ring completing the neck 8 Then remove the closing circular rings 19 Remove the insertion piece of cuff pressurization 20 and unscrew the securing nut of the cuff orifice Then you can easily remove both the sealing cuff 9 and internal supporting intermediate ring 18 from the cylinder neck 8 Normally clothing from the patient s treated extremity is to be removed as a clothing layer may prevent proper sealing the extremity in the cylinder neck At the same time the presence of clothing on the extremity precludes an important diagnostic possibility of observing colour changes in the extremity during the procedure
45. dy are free the lymphatic drainage is accelerated If the procedure parameters are properly selected the possible oedema is reduced the valves are opened Fig 1 3 Vliv VCT na proud n tepenn erven te kov no a iln mod e nete kov no krve v kon etin Stav iln ch chlopn P etlakov f ze vytla uje krev iln m syst mem Zlep uje arterioven zn tlakov sp d v kapil rn oblasti To m za n sledek op t zv en prokrven ale zv se i absorpce tekutiny z tk n Dosa en okam ik cyklu VCT d Vliv VCT na proud n tepenne erven teckovano a iln mod e nete kov no krve v kon etin Stav iln ch chlopn Sou asn se zmen uje objem ven zn krve sni uje trombotick aktivita a zrychluje lymfatick dren Ve sv m irok m spektru indikac je VCT nenahraditeln jak mikoliv jin mi metodami Fig 1 3 Schematic representation of vacuum compression therapy action on the treated extremity in a hyperbaric phase In a subsequent negative pressure phase the extravasal pressure i e pressure in tissues around vessels outside the vessel volume is significantly reduced and the resultant filtration of gases in particular oxygen nutrition substances biocatalyzers and pharmaceuticals into the tissues in a pressure gradient decline are increased The gradual secondary drop of intravasal pressure pressure inside vessels is very Important as it st
46. e 7 kPa type of treatment 4 In this manner you will proceed for example in a patient where you want in a single procedure to gradually combine effective action on the arterial and venous components of the vascular system of extremity where you must effectively treat ischemia of extremity but at the expense of oedema resulting from the grounds of insufficient drain of venous blood and lymph from the extremity In the second half of this procedure you will remove this stagnating venous blood or lymph also even at the cost of reduction of long lasting therapeutic effect The UNCOMPENSATED nature of procedure is opposed to the previously described harmonization nature The required asymmetry of therapeutic action of positive pressure negative pressure is marked both at the beginning and at the end of procedure In our case in the 1st and the 10th cycle of procedure Precisely in the middle of procedure duration i e in the 5th or the 6th cycle the positive EXTREMITER 2010 BETTER FUTURE edition 59 pressure negative pressure action is ideally symmetrical This approach can be used when you are going to combine the impact and persisting natures within a single procedure In addition it is necessary to select whether pressure changes between positive pressure and negative pressure and vice versa run as fast as possible or whether you want them slow down purposely The use of faster changes see the following figure i
47. e neoprene rings and the like rubber parts sealing cuffs printed circuit boards with electronic components electromechanical parts and electric equipment such as motors and compressors personal computer cabling and the like EXTREMITER 2010 BETTER FUTURE edition 69 Waste materials are disposed according to their nature and in accordance with local regulations and statutory regulations in force and in necessary cooperation with specialized accredited companies dealing with waste disposal No dangerous waste is included in the device The device does not produce any waste products that would 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 11 Packaging For the purposed of transport at least the application cylinder 1 and any freely movable and smaller parts should be separated from the device assembly Then these parts are to be packaged into protective packing foils In this manner packaged device can be transported only by the manufacturer For common transport individual parts of the device are placed into a wooden transport ca
48. e a fyzik ln l ka stv 2004 4 str 180 183 Matou ek P Zku enosti s vakuov kompresn terapi p i l b ischemick choroby doln ch kon etin Praktick l ka 83 2003 9 str 530 531 Matou ek P Vyu it vakuov kompresn terapie u angiologick ch a flebologick ch pacient Praktick flebologie 2006 Ro 15 3 s 56 64 ISSN 1210 3411 Pitr K Pr cha J Markov N Nov metody fyzik ln terapie v rehabilitaci pohybov ho a c vn ho syst mu kon etin Rehabilit cia 34 2001 1 str 51 58 Pitr K T e ka V Pr cha J Markov N Pitrov G Einfluss der Zeit zwischen Odemmanifestation und Behandlungsbeginn auf den Therapieerfolg bei Patienten mit sekundarem Lymphodem nach chirurgisher Behandlung von Brustkrebs OZPMR Osterr Z Phys Med Rehabil 17 2 2007 32 EXTREMITER 2010 BETTER FUTURE edition Koudela K Pr cha J Praktick mo nost objektivizace zm n prokrven doln kon etiny podroben l ebn mu vlivu vakuov kompresn terapie Rehabilit cia Vol 44 No 4 2007 Tielrooy W F Vacuum compression therapy Delft Enraf Nonius 1986 Tielrooy W F Vacuum compression therapy 2nd edition Delft Enraf Nonius 1989 Tielrooy W F The value of physioterapeutical treatment by means of alternating suction and compression in cases of peripheral disturbances in the limbs of elderly people World Congress for Physical Thera
49. e display 60 EXTREMITER 2010 BETTER FUTURE edition corner and then you can call up the pre start page of required procedure without any problems and subsequently you can start the procedure 4 2 6 Prescription From the supervising PC the additional arrangement to the device Extremiter 2010 BF edition is possible to make the prescription of the procedure for the pacients and these datas send directly to the device where the staff can very easy without mistakes start the procedure More you can find in the User s Manual of the additional arrangement to the device Extremiter 2010 BF edition 4 2 7 Termination of Control Software Running During the procedure you can see the graph of actual pressurized values in application cylinder It s time axe is pre set up for 5 minutes the distance of the vertical lines of the grating always 1 minute This standard gauge can be changed after pressing on the appropriate button on the Touchscreen in right bottom corner of the graph it appears blue field where is possible by the help of button change the gauge The change will be confirmed by the button OK The field is closed by the button X 4 2 8 Displacement of the Graph By the button in the left bottom corner goes turn red is possible to move the graph at its determinate field Database In context of transfering datas about the administrated medical procedures it was urgent to create a database This database is a s
50. e running procedure and type the required data to one or to all from the marked strips For this purpose display an auxiliary keyboard by pressing the KEYBOARD button Confirm the entered data and return to an uninterrupted course of program Note Once the parameters of running procedure are saved in the folder Favourite Procedures you can call up the saved procedure at any time In the basic menu press the button Favourite Procedures 56 EXTREMITER 2010 BETTER FUTURE edition Decide whether in the database of your favourite procedures you will select according to the patient s name and surname or identification number or according to an arbitrary previously established identifier Confirm the selection by pressing the OK button The below figure shows the result of selection according to the patient s name and surname If you do not remember precise wording of needed text you can press the button in the upper right corner of the display to call up a particular list in text format In this list search a particular text and enter it to required fields Then you will get to a pre start condition of selected procedure A particular procedure can also be called up by means of other previously entered identifier In the selection according to an arbitrary identifier such as diagnosis Enter the identifier in this example a particular diagnosis Confirm this a get directly to the pre start condition of
51. ed for this device No adjustments can be done except adjustments explicitly approved by the manufacturer The device EXTREMITER 2010 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 and or ensure these checks These functional checks and safety checks may be performed only by the manufacturer of the device or by the subject authorised by the manufacturer This subject must be qualified trained and equipped with properly calibrated measuring equipment After proper education the patient client may be left under the remote supervision of a qualified medical operator 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 a collapse condition or neurovegetative lability exists The device EXTREMITER 2010 BETTER FUTURE edition is a medical device which must not be operated without the supervision of a responsible and qualified health care professional Such a person must be able to assess and corre
52. edition EXTREMITER 2010 54 The more you are right in the table the greater intensity of therapy exists The more you are on top the more emphasis is given on the effect of positive pressure influence mostly over veins venous and lymphatic drainage and the more you are on bottom the more emphasis is given on the effect of negative pressure influence mostly over arteries inflow of fresh blood with oxygen and nutrients or pharmaceuticals In the middle horizontal row of the table marked with the value of type treatment 0 fully symmetrical values of positive negative pressure are given In terms of the established type of treatment parameter the table is divided into three parts strips The upper strip consisting of five top rows of the table with row headers 1 to 5 is dedicated for pressure parameters of procedures with prevailing positive pressure especially for the treatment of extremities with the presence of oedema or risk of its occurrence This part of the table is marked in blue as it represents an area of pressure parameters which have an impact mainly on the venous system The middle strip consists of a single row with header 0 and is dedicated for pressure parameters of the procedure with an ideal symmetry of positive negative pressure action during each cycle of the procedure For illustration this is marked in green The lower strip consisting of lower five rows of the table with row heade
53. elay 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 It is necessary to prevent from ingress of foreign objects and liquids into the device undesirable vibrations and sudden temperature changes If a risk 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 Covers of the device may 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 that are not within the manufacturer s responsibility EXTREMITER 2010 BETTER FUTURE edition 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 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 e CAUTION Alcohol based agents must not be use
54. electromagnet from the Touchscreen or remote control 11 position ON 11aa brake released position OFF 11bb brake applied The application cylinder itself 1 is placed on a separate linear guide horizontal beam 4 which enables further movement of the application cylinder in the direction of its axis namely in a length of 350 mm This separate linear guide is also used as a beam 4 of the application cylinder 1 In real life situations one or the other type of feed movement can be utilized either with the entire supporting arch 2 or with the separate linear guide 4 possibly both types of feeds can be superposed This ensures comfortable insertion putting the upper and lower extremity into the application cylinder also in the case of a tall patient with an immobile extremity and limited mobility in the area of hips knees or elbows The separate linear guide of the application cylinder 4 is manually controlled and locked using the Dual type handle 5 The application cylinder 1 is fixed on its horizontal beam 4 by means of supporting 7a and closing 7b arms provided with rubber silent blocks among which is firmly pressed and fixed after pressing the holder 16 and subsequent retraction of Dual type handles 24a 24b The treated extremity can be inserted and procedure administered only in this way fixed position of the cylinder 1 The application cylinder 1 can also be tilted within the meaning of
55. elevation or depression of the cylinder neck This tilting is performed by means of a mechanical turn mechanism 6 driven by another separate motor with a straddle gearbox and lever mechanism Tilting of the application cylinder is also remote controlled using the remote control 11 position UP neck upwards 11aaa position DOWN neck downwards 11bbb Tilting of the cylinder is very important primarily from the view point of finding the optimal position of the treated extremity towards the application cylinder mainly when passing the extremity through the application cylinder neck 8 In this neck the sealing inflatable cuff 9 is placed and this must uniformly and tightly fit around the extremity In doing so the set up of height and slope of the application cylinder 1 with regard to the treated extremity significantly facilitates the work of a device operator and at the same time contributes to the optimal administration of VCT procedures In case we are working with devices which are using the remote control 11 it is necessary to be near the device The application cylinder 1 has a removable bottom 10 fixed by four Dual type handles 17 placed around its circumference Removal of the bottom 10 of the application cylinder 1 is convenient mainly when cleaning or disinfecting the internal environment or during adjustment of extremity s position in the cylinder or when sensors of biological quantities of diagnost
56. emity EXTREMITER 2010 BETTER FUTURE edition 3 The extremity to be treated is placed into a transparent plastic application cylinder 1 and hermetically sealed using a rubber inflatable cuff 9 inserted in a cylinder neck 8 The device VAS 07 BETTER FUTURE edition fully automatically inflates this sealing cuff The sealing pressure in the cuff is dynamically controlled and minimised therefore the treated extremity is not subjected to excessive pressure by the cuff Technical conditions for the administration of this procedure are fully physiological and a number of indications of the device are significantly increased such as phlebologic and lymphologic patients with oedemas of lower extremities or with algodystrophic syndromes of upper extremities and at the same time operation of this device is significantly simplified The device s safety against the undesirable overblowing of the cuff is increasing In a positive pressure phase the arteriovenous pressure gradient in a capillary bed is strengthened and blood is expelled centrally through the venous system This results in improved perfusion and increased absorption of liquids from tissues At the same time the volume of venous blood on the periphery as well as the volume of extravasal fluid are reduced By the action of VCT the fibrinolytic activity is stimulated and thrombotic activity is slightly reduced If the lymph cycle drainage passageways in the patient s bo
57. ength x 32 diameter Operational 0 40 C wtihout sweating Storage 10 50C Wmeseepeme Operational 425 809 mmHg Atmospheric pressure otorage 120 809 mmHg F Operational 15 95 without sweating Material of plastic casing Laminate and cast Plexiglas GS Surfaces of metal parts Stainless komaxtit and aluminium surface treatment for i interiors sand blast ground eloxed Electrotechnical classification Protection of electrical power supply Weight of the entire device Dimensions cm 12 EXTREMITER 2010 BETTER FUTURE edition 2 7 Indications and Contraindications of Vacuum Compression Therapy 2 7 1 Administration of Vacuum Compression Therapy Procedures The level of metabolism in peripheral tissues depends on the exchange of gases and resolvable substances between the blood and the tissues in the capillaries Respectively it depends on capillary perfusion and capillary filtration Perfusion corresponds with the amount of open capillaries and filtration correlates with the transmural pressure it means intravasal pressure minus extravasal pressure During a chronic arterial closure the pressure on periphery is decreased and filtration is reduced sometimes followed by consecutive ischemia At the same time the compensation development of collateral circulation begins by opening and functional exchange of pre existing anastomoses The main stimulus for the creation of a collateral circul
58. eptic states hyperthermia serious hypertension with complications serious orthostatic hypotension cachexy susceptibility to phlembotromosis or thrombophlebitis the genetic load for example presence of the Leyden syndrome the use of contraceptives by women and the like VCT procedures may be indicated only by the physician If in doubts concerning the presence of the thrombus in vessels of the extremity to be treated a pre application examination excluding this possibility should be done before the VCT application 2 4 Examples of References Stvrtinov V ed Choroby ciev ucebnice angiologie str 258 262 Slovac Academic Press Bratislava 2008 For Physical Therapy 1978 H na K Pr cha J Sbornik p sp vk odborn konference na tema Zp tnovazebn zen vakuov kompresn terapie Fakulta biomedic nsk ho in en rstv esk ho vysok ho u en technick ho v Praze ISBN 978 80 260 1209 2 Praha 8 12 2011 EXTREMITER 2010 BETTER FUTURE edition 31 Pitr K Z hlava J Pr cha J Experiment ln ov en efekt vakuov kompresn terapie pod van p strojem EXTREMITER firmy EMBITRON CZ prost ednictv m erytrocyt zna en ch radionuklidem Tc Rehabilitace a fyzik ln l ka stv 3 1996 str 103 108 Pitr K Prucha J Resl V Zahlava J Z bran J Vakuov kompresn terapie Hemodynamick metoda fyzik ln l by p t let v zkum a zku enost
59. er From the viewpoint of protection against electric shock the device of Class Electrotechnical standard used CSN EN 60 601 1 eq IEC 601 1 Classification of applied part of the BE according to standard CSN EN 60 601 1 eg ICE 601 1 electrical medical device Classification from the viewpoint of protection against ingress of water or IP 30 according to IEC 60 529 solid parts Classification for operation permanent in areas internal normal areas without increased risk This device is not to be sterilized but ist possible to disinfect Sterilization it 230 V 50 Hz alternating sinusoidal Power supply voltage or if so modified by the manufacturer 115 V 60 Hz alternating sinusoidal 2 fuses T 1 25 A located inside the main switch panel accessible from outside and 1 internal fuse used as protection of primary circuit of the network transformer and 2 fuses T 5A on the DC power supply source board Pressure produced in the applicator max 15 kPa compressor max 25 Pressure produced in the cuff Max 25 kPa Panel type computer of PC standard industrially resistant with touch screen display DataLab PC LCD8 1000 Entire device assembly including packaging 220 kg Entire device assembly without packaging 150 kg Device assembly packaged 133 w x 122 d x 160 h Entire device assembly for operation 120 w x 110 d x 120 h Cylindrical applicator 100 l
60. er allow positioning of the application cylinder 1 on the laying sitting and half sitting patient Usually procedures are administered in sitting or half sitting position An integral part of the device is the application position chair 28 The successfully treating VCT procedure demands to use the special application position chair Common chairs are not suitable The chair is sufficiently robust so it enables also the treatment for pacient with hight weight and with lowered moveability After the unlocking the brake is possible to move with the pacient to the left or to the right and by this way find the most optimal position for the administration of the procedure In case of need is possible to take down the arm rest this is very favourable for the immobile pacient By this the ballast on the hip joint will be reduced The back stretcher reclines the head of the pacient and it is possible to tilt it to the supination position For VCT operation is necessary with minimal strangulation perfectly hermetically seal treated extremity in the cylindric applicator of the device For this reason new sealing cuffs from fuly biocompatibile natural rubber and hygiencically unexceptionable CIBA pigment was developped This sealing cuff have higher elasticity of the sides so treated extremity is not so much compressed For all standard extremities of the patients with diverse construction 6 sizes suffice XS S M L XL XXL In between sealing cuff
61. er of this device or relevant responsible organisation o The medical device must be properly installed in the users premises and operating personnel must be demonstrably trained 8 EXTREMITER 2010 BETTER FUTURE edition EMBITRON s r o is an exclusive authorised provider of service care for this device in the Czech Republic The requierement of the producer on the stuff s qualification The prescript of the procedure is performed only by the doctor The administration of the procedure is performed only by the medical or by the properly medical trained person 2 5 Safety Instructions The device EXTREMITER 2010 BETTER FUTURE edition was designed and manufactured for as safe as possible use However its safe as well as purposeful and effective use depends on a qualified prescription of procedure 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 EXTREMITER 2010 BETTER FUTURE edition as well as information in connection with the physical and therapeutic method of vacuum compression therapy It is also necessary to follow further development of knowledge in this area of medicine to apply therapeutic procedures by persons with relevant medical qualification and to observe all necessary legal provisions regulations and recommendations in force Users of this de
62. erapy Procedure The procedure will be automatically terminated after the elapse of a pre selected procedure time or after the elapse of a pre set number of cycles periods Then the procedure can be repeated with the same biotropic parameters or other procedure can be selected or the control software can be stopped Note After finishing the procedure and removal of the extremity from the application cylinder 1 the cylinder can be ventilated it means air flow can be used and mist or odour can be removed In the event that it is necessary to terminate prematurely administration of procedure during the procedure it is necessary to choose a method of premature termination corresponding to urgency of arisen situation If possible wait until the negative pressure in the application cylinder is reduced At the time when the zero atmospheric pressure is reached in the cylinder 1 end the procedure by pressing the STOP button However if the situation is extremely urgent you can end the procedure at any time The extreme possibility how to end the procedure is to remove the insertion piece of EXTREMITER 2010 BETTER FUTURE edition 65 pressurisation 20 from the orifice of the sealing cuff 9 In most cases this operation can also be made by the instructed patient In other cases permanent surveillance must be present at the patient After ending the procedure the operator of this device will remove the insertion piece of pres
63. erated by computer during the procedure In context of this ability the autodiagnostic subssystem monitors and controls all technical parametres during the procedure In case any of these parametres want to exceed the limits the user is informed about this immediately Meantime the automatic tries to set up the tilted parameter For example the sealing cuff t not manage the appropriate pressure so the device draws the attention and tries to pressurize it So it is not an error yet In case it is not possible to presurize the sealing cuff the device report the error And than it is necessary to look for the mistake For example the user has to change the involved sealing cuff In case a weighty error the procedure will be stopped It is possible to switch between the reports It is necessary to consider that the limits of watched parametres are sett up in control PC and it is possible to change them SW SETUP of the device It is also possible to create milder or stricter standards for work of automatic autodiagnostic subsystem of the device These limits are from the producer so pre sett up to satisfy all users In case the user want to change these limits it is kindly recommended to entrust the producer It is possible to make this operation at a distance via the remote technical managment by help of internet or on the signal GSM through GPRS modem More in the User s Manual of the additional arrangements of the device In the lef
64. f patients with cardiac oedemas On the contrary cyclic replacement of a certain appropriate volume of blood between the treated periphery extremity and the centre of body s haemodynamics heart induced by VCT favourably stimulates the entire circulatory system In the circulatory system the VCT application stimulates the effect of light physical training which has a favourable impact upon the heart pump activity heart haemodynamics The left heart chamber performance and pulse heart output are slightly increased the resistance of systemic vasculature vasodilatation is induced is reduced and heart inotrophy is favourably influenced The blood pressure is slightly increased in the course of procedure especially in the positive pressure phase analogy of physical training however after finishing the procedure the desirable decrease in blood pressure occurs These effects can be utilized in supportive treatment of functional systemic circulatory abnormalities in early stages of their development within the framework of primary or secondary prevention for example reduced circulatory performance increased blood pressure Finally we can resume the effects occurring during the positive pressure and negative pressure phases alternation of VCT e The transmural pressure on the capillary wall is changed and subsequently the exchange of gases oxygen CO2 and substances including any pharmaceuticals between blood and tissues
65. first cycle of procedure will start with required asymmetrical pressure values for example 7 kPa 11 kPa and this asymmetry is very slowly reduced in each next cycle of procedure and in the last cycle of procedure here for example the 10th cycle of procedure you will end with ideally symmetrical values of positive pressure negative pressure i e 7 kPa and kPa This means that the asymmetry effect of acting positive pressure negative pressure is considerably eliminated at the end of procedure This is appropriate in patients where the asymmetry of positive pressure negative pressure is therapeutically required but you want this action to slowly disappear during the procedure In this manner for example in patient with ischemia of extremity treated with the prevalence of negative pressure of 11 kPa 7 kPa you will fight against the risk of development of oedema of the extremity resulting from the aspirated arterial blood into the extremity the patient may have be apt to The LASTING nature of procedure is opposed to the previous impact nature This means that in the first cycle of procedure you will start with ideally symmetrical values of positive pressure negative pressure in our illustrative example 7 kPa 7 kPa but asymmetry is very slowly increased in each other cycle of procedure in the direction of required type of treatment and in the last cycle of procedure here for example the 10th cycle of procedure
66. g without oedema Without oedema 5 With oedema With oedema Without oedema beginning With oedema Dojo1naN without oedema with oedema jo 59 without oedema uy sisaued jesay diag With oedema 12A Jo suoneardde 221 Wilhout oedema With oedema Without oedema Grade 5 after Wagner Meggit Grade 4 after Wagner Meqgit 10 2 Aboponoe pas Diabetic foot Grade 3 after ropatic mixed gner mege o F Grade 2 after gner Meggit Diabetic lymphoedema Grade 1 after of ron enti Wagner Meggit Grade O after Wagner Meggit Wilh a predominance Diabetic claudications ol expressive oedema 7 P dominance of arterial and as well venous affection With a predominance Diabetic sensomotorical of arterial alfection yyneuropatt EXTREMITER 2010 BETTER FUTURE edition Group 5 Disorders of movement system of extremities with expected therapeutical effect of improved profusion and trophism in tissues 24 Tendovaginitis chronica Tendovaginitis acuta Tendinitis acuta Regeneratio cutanei Omarthrosis omalgia Oedema chronica Oedema acuta Myorelaxatio Myopathia Myogelosis lii Cicatrix chronica Cicatrix cheloidea f Bursitis chronica 3 59 B Arthrosis chronica d is articulatio c
67. g the closing arms 7b and connecting holder 16 Slightly take away the released arm from the edge of horizontal beam 4 and go out of rollers with the entire linear travel Caution The beam 4 and arms are relative heavy Reassembly should be done in a reverse manner After meeting all appropriate conditions for the safe operation of electrical network devices in medical premises the Extremiter can be connected to a relevant electricity network BUT only through the UPS Uninterruptible power supply and the main switch block 25 can be switched on Leave the device switched on for a few minutes and monitor its behaviour You should hear only a quiet sound of cooling fans On the monitor touch screen of the device 13 monitor the start of computer and application control software Neither atypical sounds should be heard nor unusual odour felt If the device does not start after switching on protective blow out fuses located in the cord block 25 will probably be damaged Replace these fuses with the provided fuses of a same type and value T 1 25 A The fuse case can be opened by its turning with a tool inserted in an accessible groove of the case Caution If you need to replace fuses the device must be turned off and mandatory disconnected from the electric distribution network During the start up of the device you can prepare a remote control 11 Open the remote control case in a marked place and insert a miniature power s
68. he intensity of its action each group is divided into a group of procedures with a very mild intensity 3 procedures a group of procedure with a standard intensity one procedure a group of procedures with radical intensities 3 procedures a group of procedures with extraordinary radical intensities 3 procedures EXTREMITER 2010 BETTER FUTURE edition 57 The selected group of procedure s can be chosen by pressing the OK button for example selected standard intensity in this sense the total power of action will provide a well proven therapeutic procedure with the following pre start table Then the procedure can be started up or modified To unlock the lock press the button and hold it for a while and then for example you can reduce the value of negative pressure from 8 kPa to 7 kPa by pressing the button at a reduced value of negative pressure 4 2 5 Procedures According to Users The device EXTREMITER BETTER FUTURE edition enables also to work with procedures whose all biophysical parameters are selected fully individually by the user This regards the folder Procedures According to Users which can be opened by pressing the relevant button Then the screen of selections of all therapeutic parameters will appear and it can be gradually filled out First in the top row select the intensity of procedure symmetrical value of pressure negative pressure for example 7 kP
69. he treated extremity in the horizontal direction is performed by two systems a by feed of the cylinder along the linear guide of a horizontal beam of the application cylinder b by feed of a vertical supporting arch 2 According to patient s condition and mutual arrangement of the patient and the device it is possible to select the option a or option b or to combine these two options within the sense of their superposition and to put the application cylinder on the to treated extremity with a limited mobility in a comfortable manner By the same way the extremity is pushed out from the application cylinder Any lateral feed between the treated extremity and application cylinder 1 i e feed at the horizontal level of inserted extremity if necessary in practical application is resolved either a by slight lateral movement of the application chair with the patient on brake released travelling wheels of the chair and subsequent careful application of wheel brakes in an optimal position or b by slight lateral movement with the entire device by means of its brake released travelling wheels and once the optimal position of cylinder against the extremity is achieved the travelling wheel brakes must be properly applied The goal is to achieve such an position of extremity with regard to the cylinder 1 when the extremity is enlaced surrounded with the sealing cuff 9 along the periphery uniformly and the extremity is coax
70. herapy Subchronic hard difficulties hard difficulties 2 8 hard difficulties hard difficulties hard difficulties hard difficulties hard difficulties hard difficulties g g g g g g Ils g a a 2 2 3 2 2 0 s 9 5 3 9 3 3 z s E 5 2 a E E E E E E 8 8 2 8 2 2 8 z ee ee ze ze 5 5 2 5 2 5 5 f 1 H d H with both disorder Posttramatic swellig Cutting wounds posttraumatica Osteosynthesis i Distortio Luxatio Musculus scissus stensio muscularis HA Contusio Combustio Conditions after a fracture of lowerupper extre o co a O Ww U o eo D o c D o ca 01500 19 4 SUOI IPUOD aAneJa EXTREMITER 2010 BETTER FUTURE edition Group 9 Bone disorders of extremities with an expected therapeutical effect of improved profusion and trophism in tissues Procedures in agreemen with diagnose Conditions after a frature Osteosynthesis Pseudoarthrosis ununited fractures Affections of limb bones with supposed influence of improved circulation and trophicity Osteonecrosis With both disorder Wilh a disorder of trotic of troficity and oedema with oedema of injured tissues beginning M Osgood Schaltter 27 EXTREMITER 2010 BETTER FUTURE edition Group 10 Cosmetic a
71. here a serious organic serious blood disorder exists and this should be carefully diagnosed and resolved Any bandages covering for example chronic skin ulcerations varicose ulcers are mostly not removed during the VCT procedure In this manner significant contamination of the application cylinder is prevented Bandages are to be removed only if this can have a diagnostic importance for example objective assessment of possible bleeding from a wound or a defect on the extremity during the procedure The patient s extremity prepared for treatment is in front of the orifice to the neck 8 of the application cylinder 1 To meet this condition the brakes of travelling wheels can be released desired position of the Extremiter found and the brakes of travelling wheels applied Then using the remote control 11 you can adjust the approximate height of the application cylinder 1 and its slope Caution In doing so keep the remote control as close as possible to the plastic cover of the device base in the area under the control computer 12 This requirement must be respected especially in a strong electromagnetically interfered environment The remote control signal itself can not be too strong to avoid interference of other high frequency electromagnetic sensitive equipment in the vicinity of the device Estimate which inner diameter of the internal sealing cuff 9 corresponds to a thickness of the treated extremity Verify the acc
72. ially collinearly positioned with the longitudinal axis of the application cylinder 1 not sideways For this reason the upper extremity sometimes also the lower extremity must be padded in the application cylinder 1 using one or several pads Slightly inflated exercise balls are to be used The extremity in the cylinder 1 is padded and the extremity will sink into these balls All decisive mechanical electrical and pneumatic parts of the device are well arranged on a robust base of the device provided with an elegant plastic cover The powerful control computer placed in a plastic box 12 at the top of the vertical supporting arch 2 is used for the control of the device and monitoring of administered VCT procedure s The device is operated exclusively using a touch screen 13 Procedures from the following five groups folders can be selected on this display Well proven procedures Procedures according to diagnoses Procedures according to users Prescriptions Procedures which are prescripted by the doctor on his supervising PC Favourite procedures Special procedures The folder Well Proven Procedures includes physical parameters of the procedures that were successfully used as standard pre programmed procedures at previous models of the device EXTREMITER 2010 In addition these procedures are divided into 3 subgroups subfolders as follows 6 EXTREMITER 2010 BETTER FUTURE edition 1 Procedures suit
73. ic instruments are put on the patient s extremity 36 EXTREMITER 2010 BETTER FUTURE edition The device is intended for power supply 230 V 50 60 Hz and it is constructed in the el class Through its robustness and efficiency the supply is only 220 W it is very necessary the device is connected to the electrical power network only through UPS Uninterruptible Power Suply which is delivered as a part of the device The control and actuating unit of the device EXTREMITER 2010 Better Future edition is a highly resistant computer of industrial standard placed in the upper control box 12 The touch screen of this computer 13 is intended for displaying control and check tasks of VCT procedure and for the control in a touch mode The entire device is mobile on four freely design turning travelling wheels 14 provided with foot brakes 14a Brakes of travelling wheels are accessible as foot brakes If however the travelling wheels turnable around their vertical axis get under the plastic cover of the device base 3 then the brakes 14a must be pressed or released manually Good manoeuvrability with the device possibility of a remote controlled motor driven feed of the application cylinder 1 along the shark fin type supporting arch 2 within a wide range of roll out and roll in of the application cylinder 1 upon the treated extremity up to 650 mm as well as the remote control of motor driven tilting of the cylind
74. ice shows damaged covers encapsulated parts control computer cylinder applicator and the like and or parts responsible for mechanical stability special care should be taken to integrity and function of the Dual type fixation handles e any pneumatic distribution systems hoses or its connectors are damaged e The use of the device EXTREMITER 2010 BETTER FUTURE edition must never become a reason for failure to perform or take away other necessary medical care procedures e he device may be operated only with a fully inserted and secured electrical connectors and couplers as well as air supply pneumatic connections e f it is necessary to adjust the height of the application cylinder in relation to the treated extremity in the course of running procedure the vertical motor operated feed along the supporting arch resp motor driven tilting of application cylinder 1 is used These feeds are remote controlled e Inthe event of started procedure and inserted extremity in the cylinder 1 these feeds must be performed very gently and with care EXTREMITER 2010 BETTER FUTURE edition 11 2 6 Technical Characteristics of the Device EXTREMITER 2010 BETTER FUTURE Edition Health classification Medical device of Class ll a 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 or 115 V 60 Hz if so modified by the manufactur
75. idiosis also many air toxins and radioactive elements The producer of these filters requires their exchange after each device running but the time of the running is not specified The primary using of mentioned filters is in the medical area detach epecially for the protection of the medical stuff against consequential infections type SARS etc at using these respiratory filters in appropriate masks or half masks The intervals for the filter exchange is necessary to set directly at running of the device It depends on the dustiness of the environment potencial concentration of the infectious germs in the air of the working place and naturally above all on the state of the treated extremities on the presence of their surface microbial flora and on the exposure for the pacients and for the stuff The interval of the filter exchange is suitable to take into the disinfection rule of the appropriate medical working place The service life of the original packaged and appropriate stored filter 10 C till 50C 75 Rhmax is 10 years After the removal from the original packing is the lifetime of the filter 6 months what is the longest possible time its persistence in the device The demands for the surrounding are O C till 40 C Rhmax 95 68 EXTREMITER 2010 BETTER FUTURE edition Before the filter exchange switch off the device The exchange of the first filter see the picture no 7 the one with the white cover is made by screwing
76. imulates the collateral vascular circulation and improves perfusion on a long term basis Fig 1 4 Blood is supplied through opened arterioles and newly created collaterals also into obliterated peripheral sections where thanks to an induced pressure gradient the metabolism between intravasal and extravasal areas is improved The creation and development of collateral circulation and 4 EXTREMITER 2010 BETTER FUTURE edition neovascularization is stimulated This results in demonstrably better trophism nutrition and metabolism of tissues in the area of treated extremity and even in other near parts of the body Vliv VCT na proud n tepenn erven te kov no a iln mod e nete kov no krve v kon etin Stav iln ch chlopn V podtlakov f zi doch z ke sn en extravaz ln ho tlaku se zv enou filtrac plyn a l tek do tk n gt oS EAM m o T e m 2 A mi JE Dosa en okam ik cyklu VCT Vliv VCT na proud n tepenn erven te kov no a iln mod e nete kov no krve v kon etin Stav iln ch chlopn Druhotn pokles intravaz ln ho tlaku stimuluje kolater ln ob h a t m i prokrven Fig 1 4 Schematic representation of vacuum compression therapy action on the treated extremity in a hypobaric stage Pressure differences occurring during vacuum compression therapy al
77. installation If the local electrical distribution network uses other types of sockets that are used in the Czech Republic consult this situation with a qualified electrician who is responsible for use of adapters or installation of other types of connectors In the case of local electricity networks of another type of protection against dangerous line voltage it is necessary to ask for the opinion of local skilled and responsible authority The power supply voltage and line frequency must be strictly observed Caution Any intervention must not affect the electrical classification of insulation safety of device Class l 42 EXTREMITER 2010 BETTER FUTURE edition Caution Read the device labels and study carefully the instruction manual Accompanying User s Documentation Caution If the device is brought into a warm room from the outside cold environment it may be misted with condensed water vapours The device can be connected to the electricity network and switched on only if it is completely dry Note If the device must be transported for example to a place with a narrow door the horizontal beam 4 must be removed In removed application cylinder 1 take off one of the stops 23a 23b of linear travel Then on the same side unscrew two bolts at the edge of linear feed horizontal beam 4 fixing the supporting arm 7a In doing so the fixation handles 24a 24b of arm must be firmly tightened to avoid collapsin
78. is her workplace remotely from the device allowing procedure prescription for a particular patient sending the prescription electronically directly to the control computer of the device 72 EXTREMITER 2010 BETTER FUTURE edition
79. ith other physiotherapeutic methods such as devices which produce only underpressure or only overpressure or even devices which use compressive sleeves for pneumatic drainage The scope of indication of both these methods is not identical at all By their nature compressive methods of instrument based lymphatic drainages are based only on the action of pressure when venous blood and lymph are expelled from the extremity mainly by a gradual local pressure wave in the pressure sleeve and reduce possible oedema and pressure in peripheral tissues The circulation is promoted in this passive way but only if arteries and capillaries are fully capable of utilising such an evoked situation Instrument based compressive lymphatic drainages also significantly influence the consistency of oedema from the therapeutical point of view by changing a solid oedema to elastic one thus help in creating conditions for the recovery of painless movement of extremity Compression alone however cannot evoke the effective aspiration of a necessary volume of new fresh blood into a partially or wholly obliterated part of the extremity and cannot accelerate the circulation process in the periphery and significantly contribute to improvement of metabolism in the affected peripheral tissues also in situations when arteries and capillaries are not able to ensure spontaneously a sufficient supply of blood or exchange of metabolites no matter whether this state is a consequence
80. ities with an expected therapeutical effect of improved profusion and trophism of tissues e Cosmetic applications e Elimination of consequences of excessive or insufficient stress of extremities and increase of their physical potential e Preventive use of vacuum compression therapy Other more detailed hierarchic structure of these groups is specified in another text of this user s manual In the folder Procedures According to Users the user of the device EXTREMITER 2010 BETTER FUTURE edition may creativity develop procedures with its own parameters In the folder Favourite Procedures favourite and frequently used procedures can be stored thus facilitate operation of the device The folder Special Procedures is accessible only to researcher workers at this moment The procedures in this folder are aimed both for various forms of feedback control of vacuum compression therapy utilizing diagnostic measurements on the patient s extremity being treated in real time and simultaneous therapeutic utilization of gaseous carbon dioxide In the folder Prescription are saved the procedures which are prescripted by the doctor on his her supervising PC and they are wireless sended to control PC of the device where they will be applied by the physiotherapeutist EXTREMITER 2010 BETTER FUTURE edition 7 2 General Information 2 1 Device Manufacturer EMBITRON s r o Borska 55 301 00 Plzen Czech Republic www e
81. l transport The withdrawable holders 30 can be provided with rubber protection to facilitate manual transport Caution After installing the device the withdrawable holders 30 must be placed under the device base Further all protective transport packages must be removed Then release the arm fixation handles 24a 24b and lift off the closing arms 7b by pulling the holder 16 The application cylinder 1 is to be placed into a created area in such a way that the bottom of the application cylinder is directed towards the side of the base 3 with incoming mains cord 25 The application cylinder must sit down on silent blocks of the supporting arms 7a Then the closing arms 7b are to be put on the application cylinder 1 using the holder 16 and silent block of closing arms 7b are to be firmly pressed on the application cylinder 1 In this position the arm fixation handles 24a 24b are to be firmly tightened The fixation handles 24a 24b are placed with threads in the opposite direction therefore the direction of tightening releasing is contrary Caution All fixation Dual type handles enable usual tightening or releasing or idle rotation with the handle This idle rotation of handle can be achieved by lifting up the handle in the direction of bolt axis at concurrent pressing holding the upper part of the handle Further check tightening and if necessary tighten the fixation handle 5 intended for locking the
82. level is compensated by setting a suitable height and slope of the application cylinder 1 the crossway location of extremity in horizontal level can be compensated only by side travel or turning the application armchair on its travelling wheels Naturally it is possible to used side travel or turning the entire device wheel brakes must be released Released brakes of the device wheels and application armchair must be applied firmly again If so allowed by the situation the patient can slightly change its sitting position in the armchair however its final position must be fully comfortable and firm Caution It is important to use the special application position chairs Caution The sealing cuff 9 must fit uniformly and tightly enough around the extremity Therefore a sufficient amount of sealing cuffs with all necessary internal diameters must be available The cuffs with the following internal diameters are used XS S M L XL XXL The sealing cuff 9 must tightly enough fit with its cylindrical area around the inserted treated extremity however the extremity must not be constricted Caution Some leakages between the cuff and extremity can be compensated by a neoprene ring which is to be put over the extremity and it will fill a space between the extremity and somewhat larger 44 EXTREMITER 2010 BETTER FUTURE edition opening in the cuff The neoprene rings are available in the wall thickness of 0 5 cm They can be m
83. linder to prevent from abrupt run off the cylinder along the tilted linear travel As well as you can check superposition of cylinder feed 1 in the direction of its axis both by feed of linear horizontal travel 4 and by manual travel of the entire brake released shark fin type vertical supporting arch 2 Check also complete roll out of the application cylinder 1 from the patient and subsequently complete roll in of the application cylinder 1 towards the patient in order to slide the application cylinder over the patient s unbent extremity The patient is always located in the vicinity of the application cylinder neck 1 i e on the opposite side of the appliance inlet of electric power supply 25 The above specified handling should be checked both in the lower position of the application cylinder 1 where lower extremities will typically be treated as well as in EXTREMITER 2010 BETTER FUTURE edition 43 the upper position of the application cylinder where upper extremities will be usually treated as well as in the middle position which correspond to treatment of a patient sitting on a high bed or couch Handling should be checked at the horizontally placed cylinder as well as at variously tilted cylinder Manual and motor driven travels must go fluently and smoothly If an original chair is part of the delivery test its travel on travelling wheels as well as brake application brake release of these wheels Also
84. linear travel of the application cylinder 1 in the direction of its axis to prevent spontaneous travel of the application cylinder 1 when the cylinder is tilted in linear displacement Adequate and uniform tightening of all four handles 17 fixing and sealing the bottom 27 of the application 1 should also be checked Connect the insertion pieces of hoses 21a 21b to the cylinder bottom 27 for pressurization and vacuum application of the application cylinder 1 These insertion pieces can mutually be located arbitrarily The insertion pieces of hoses are designed as quick release connectors which means that connection can be made by mere insertion of insertion pieces into openings of the pneumatic connector on the bottom of the cylinder 27 and disconnection is made by pulling out the insertion piece in the direction of axis of the pneumatic connector at concurrent pressing the ring at the connector nose in the opposite direction towards the bottom of the cylinder 27 On the linear travel 4 check the presence of both distance stops of travel 23a 23b Check also whether the main power switch located in the cord block 25 is switched off Once you check the safety and suitability of electrical installation according to valid local standards in the area where the device is to be installed you can connect the plug connector of mains supply to appliance inlet of the device 25 and insert the mains supply to the outlet of electrical
85. long the periphery Do not use excessive tightening force If necessary the handles can also be tightened under operation During transport and demonstration operation the neck 8 of the application cylinder 1 is provided with an inflatable sealing cuff 9 with the opening of 16 cm in diameter sealed with a gland fixed in the neck 8 from both sides with supporting 18 and closing 19 circular rings with internal diameters of 14 5 15 cm or 12 cm Only for the testing and demonstration purposes the internal diameter of circular rings is lower than the internal diameter of sealing cuff 9 Caution For treatment of patients however the internal diameter of supporting 18 and closing 19 circular rings must be higher than the diameter of sealing cuff 9 The optimum difference of diameters should be 2 3 cm Caution The extremity may be in contact only with the sealing inflatable cuff 9 not with the supporting 18 and closing 19 circular rings This can be achieved by combination of cuff and circular rings of appropriate diameters as well as optimal positioning of the application cylinder 1 specifically by adjusting the optimum height of the application cylinder 1 and in particular by fine tuning of its slope In addition it is necessary to ensure that the patients extremity is not directed crossways to the cylinder axis when he she sits in the application chair While the crossway location of extremity in vertical
86. lour changes in the extremity during the procedure According to the internal diameter of sealing cuff select the appropriate supporting 18 and closing 19 circular rings The internal diameter of circular rings should be 1 3 cm larger that the internal diameter of sealing cuff 9 The extremity should never come in contact with supporting or closing circular rings Caution To quickly select sealing cuffs or supporting and closing circular rings you can advantageously use a wall mounted suspension magazine First insert the supporting circular rings 18 into the neck 8 of the application cylinder 1 Then insert the sealing cuff 9 Make sure the correct orientation of its orifice so that it precisely comes through the opening at the top part of the cylinder neck 8 Press the sealing cuff 9 upwards at the point of orifice In doing so support the orifice with hands through the opening in the neck 8 Then screw up the securing nut to external threading of the cuff orifice 9 Complete the sealing assembly of the cylinder neck 8 by adding selected closing circular rings 19 Put the cut out segments over the circular heads of securing bolts fixed to Plexiglas ring finishing the neck 8 Pin down the closing circular rings uniquely and sufficiently in the direction of cylinder neck and turn the circular rings up to a stop element In this manner you prepared the sealing assembly of the cylinder neck Finally do not forget
87. mbitron eu embitron embitron eu 2 2 Authorised Distributor and Service For the Czech Republic EMBITRON s r o Borska 55 301 00 Plzen Czech Republic For 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 In case of any problems or doubts the user or the person responsible should immediately contact the manufacturer or the authorised distributor This manual is intended for all users of this device as well as responsible organisations that 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 or are responsible for operation of this device This user s manual must be part of each device and available to all persons working handling 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 EXTREMITER 2010 BETTER FUTURE edition is 24 months as from the date of its sale In the event of warranty claims the properly completed Guarantee Ce
88. mia cum oedema intermitens and the procedure can be started If at any time you select Procedures According to Users in the basic menu a menu intended for compilation of user procedure will appear but it is not necessary to compile a particular procedure in a complicated manner but pressing the Load Procedure button you will enter the database of saved user procedures Enter the identifier under which a particular user procedure was saved if you forgot the precise name of this identifier by pressing the button you will call up all identifiers of saved user procedures After confirming the selection the pre start page of searched user procedure will appear and you can start this page After starting this procedure all parameters are saved in the procedure folder called Procedures According to Users but generally you can consider this procedure as favourite therefore it can be saved also in the Favourite Procedure folder This can be done of course during the procedure by pressing the SAVE button after confirming the selection save this favourite procedure for example under the name and surname of the patient If you select at any time the Favourite Procedures folder in the basic menu you will make a selection of identifier of particular type here the patients name and surname enter the name and surname searched if the precise syntax is forgotten use the button in the upper right of th
89. n you will get into the basic status of computer that can be switched off similarly as a regular PC sequence of the START and SHUT DOWN buttons 4 2 2 Procedures According to Diagnoses From the basic menu you can usually proceed further and select a particular group a procedure folder Procedures According to Diagnoses Well Proven Procedures Procedures According to Users Favourite Procedures In case we are using the additional equipment of the device the PC supervision you can also use the folder Prescription s very probable that the Procedures According to Diagnoses will be your most frequent option 46 EXTREMITER 2010 BETTER FUTURE edition 4 bk b Here the patient s disease is to be entered more specifically in gradual hierarchic options To confirm your selection press the OK button on the right next to specification In selection from more extensive lists individual specifications are achieved by pressing the up arrow up or down arrow buttons or you can move to the beginning of this list by entering one relevant hierarchic level or you can move to the end of this list For this purpose you can use usual buttons the highlighted up arrow down arrow buttons In selection of some diagnoses there will be a higher number of hierarchic finer and finer selection levels You can return one step back at any time or you can go back to the basic menu the MENU button To illustrate this
90. n moving by one step you will find yourselves for example from field 8 6 kPa on field 6 5 kPa These described movements are significant because the sense orientation of therapeutic procedure given by combination of positive pressure and negative pressure will not be changed From a particular field however you can move in other directions too in movements horizontally to the right to the left you will maintain the type of treatment but you will change the intensity of action in movements vertically upwards downwards you will maintain the intensity of action but you will change the type of treatment In movements in the diagonally opposite direction downwards to the right upwards to the left you will maintain the size of positive pressure and you will change only the size of negative pressure EXTREMITER 2010 BETTER FUTURE edition 55 In the middle row of the table there is the type of treatment 0 the action of positive pressure and negative pressure is in absolute symmetry and by movement along these fields of this row only the intensity of procedure can be changed The transition to a newly selected table filed with modified pressure parameters is practically made by long pressing holding the button made up of a selected field Caution During this long pressing new selected pressure parameters can be read at the top of the display in mmHg If the selected field is pressed and held for a cert
91. ng cuff in case it will be damaged than will be necessary a difficult repair Also it is very necessary to watch out that the measuring capillary which goes through the compression hoses of the sealing cuff has to be pushed out from the end of this hose Together it should be put into the tyre valve of the sealing cuff as deep as it is possible Other attention is to be paid to control from the touch screen 13 of the control computer 12 4 2 Administration of Vacuum Compression Therapy Procedures by Means of Control Computer 4 2 1 Introduction The basic menu of device will display on the monitor Check the language on this display To change the language press the LEFT ARROW BUTTON EXTREMITER 2010 BETTER FUTURE edition 45 Then the language selection menu will appear To select a required language touch a particular flag If you cannot find your language in this set of flags you can touch the globe icon to display other flags Caution The provided devices are usually equipped only with a limited number of language options whose utilization is expected at a place of installation In the above menu you can also switch on or switch off an audible alarm of the device the bottom at the left lower part of the display The basic menu is usually accessed by selection of a required language The basic menu also enables the standard exit of application software namely by pressing the EXIT button After this actio
92. ny external additional filters located at the bottom 10 of the application cylinder 1 are cleaned and maintained by the operator of the device filters hidden inside the device are replaced during regular checks of functionality and safety of device within the framework of its technical maintenance and these activities are performed by the qualified trained and by manufacturer authorised technical personnel 4 8 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 maintaining the device in cleanness and in a necessary disinfection condition The operating personnel must observe all safety instructions specified in this manual or provided during installation of the device and or training of operating personnel In addition it is also necessary to 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 The additional device type CO2 Therapy edition Better Future is except the germicidal lamp equipped by two HEPA filters their exchange is necessary during the device running These corpuscular filters with high effectivity minimally 99 99 catch the firm and the liquid elements including viruses bacteries and germs of spor
93. of the old filter in the direction to the left and by screwed the new filter in the direction to the right The exchange of the second filter see the picture no 7 the one with the black cover will be made by the same way after the uncover of the cylinder s cap Use only the prescripted filters by the producer 2 pcs the type PF10 P3 PSL code 052670 Very effective HEPA filter It responds to the class P3 Caution In case of the filter s exchange till 15 minutes from the shutoff of the device could be silvery rustless cylinder of the cover of the germicidal lamp hot and it can threaten the possibility of scorch of the stuff 4 9 Regular Functional and Safety Checks of the Device The device EXTREMITER 2010 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 According to the local legal provisions and regulations in force it is the responsibility of relevant institution who utilises the device to ensure its regular inspections i e regular checks of functionality and safety The manufacturer recommends performing these checks once per year A check report must be prepared about the check performed and the responsible institution health facility physician physiotherapeutist and the like meets in this way the requirements of EU legislation regarding medical devices In the course of perio
94. ork Places and in the left column we click on the line View network connection We click on the pictogram Local Area Connection 2 and in other window we click on the button Properties In the protocol schedule we choose the Internet Protocol TCP IP and we will press the button Properties Then we set up the network parametres G The connection to the remote control by the help of program TEAM VIEWER and Internet In case we need the SW technical support and we have to make accessible all SW of the control PC we use the special program TEAM VIEWER Withal has to be connected the cabel into the appropriate connector LAN of the control PC First we contact the technical advicer by the phone and after start of the progamme TEAM VIEWER we tell him of nine digits number ID with which was the program TEAM VIEWER started After this can the technical advicer enter to the control pc and provide some essential operations H Keybord option The external keybord can work in the international mode QWERTY or in the mode of czech keybord QWERTZ l Restart or switch off of the PC This we will do ordinarily RESTART or SHUT DOWN When we shut down the PC it is important to finish the OS WINDOWS EMBEDDED and then switch off the PC 4 2 10 The ending of control SW To this purpose we will push the button EXIT on the display of the basic menu 62 EXTREMITER 2010 BETTER FUTURE edition 4 3 Preparing the Device and the Patient for Procedure A
95. ormed along an adequately big circle or ellipse whereby the travelling wheels freely rotating along their vertical pins will be set up to the correct travel direction at subsequent travel with the entire device on the extremity In putting the extremity into the application cylinder it is practicable that the extremity slides easily along the internal cylindrical area of the applicator 1 especially if the patient cannot lift up its extremity This can be achieved in different ways For example remove a pad to pad out the extremity from the application cylinder 1 insert a hygienic medical grade paper or similar material under the distal part of the extremity most frequently under the heel or under the arm so the extremity can be slightly slid down when the application cylinder 1 moves In more complicated cases you can open and remove the cylinder bottom 27 and manually handle the extremity in the cylinder In the removed bottom of the application cylinder 27 the extremity can be optimally padded 64 EXTREMITER 2010 BETTER FUTURE edition out Padding of extremity is very important in order to prevent any callous heel arm as well as to ensure the optimum slope of extremity directly in the application cylinder The treated extremity should be positioned in the axis of the application cylinder This is an important condition This condition is usually well met for the lower extremity due to its suitable anatomy The upper e
96. pplications moderate risc siapiosip JO sew tji 015 papiuuM beginning cheloid 28 suoneaijdde jeanawsog 90199106 Group 11 Elimination of consequences of excessive stress of extremities and increase of their physical potential Simultaneously influence of multifactorial sterss UJIM ul 591809201 095009 jo uoreuiuim3 Static stress of lower extremities generally jenuajod jesis ud sy jo saiiu1 xa JO 559115 BAISSB9X9 JO saJuan Walking with standing about EXTREMITER 2010 BETTER FUTURE edition Preventive use of VCT Group 12 Procedures in agreement with diagnose stes of motive apparatus prevention high weakening Moderate weakening low weakening Cardiovascular s effecti prevention defici preventi E E ntion Disorders of skin moderate risc Vasoneurosis prevention Moderate risc Preventive application of VCT Moderate risc conditions without s s time hii PERH P Swe prev aethi and in moderate risc prevention and insufficiency revention Lower extremities ischaemic disease venous moderate risc Venous insuffici prevention Ischaemic disease prevention 29 EXTREMITER 2010 BETTER FUTURE edition 2 2 2 Procedures indicated according to formerly exclusively u
97. pressure is also suitable for the treatment of local painful conditions associated with the oedema without organic vascular affection such as algodystrophic syndrome and for the treatment of some post traumatic conditions Once the oedema is under control you can use positive pressure negative pressure symmetric values Duration of the VCT procedure ranges from 20 minutes up to 30 minutes as the minimum in order to perform at least 10 positive pressure negative pressure cycles during this procedure In individual and well founded cases this procedure may take a very long time Nevertheless care must always be taken with regular interruptions of the procedure or it is necessary to monitor appearances of imminent callus along with the patients comfort A long term procedure may also be divided into several shorter procedures performed during a single day At the beginning of treatment VCT is usually applied daily then three times a week twice a week or once a week maintenance treatment In indicated cases the VCT procedure may be performed for a longer time or repeatedly During VCT applications the patient must comfortably and safely sit on a stable armchair or chair Optimally the armchair should have a higher placed sitting area adjustable back rest preferably while treating the under extremity the patient should be in a half sitting half lying position while treating the upper extremity the pacient should sit in upright form
98. py 1978 Gajdujkov S N Primenenie abdominalnoj dekompresi v akuSerstve Teorija i praktika Gosudarstvenaja pediatri eskaja medicinskaja akademija Sankt Peterburg 2007 McCulloch J M Jr Kemper C C Vacuum compression therapy for the treatment of an ischemic ulcer Physical Therapy Vol 73 No 3 March 1993 Akbari A Moodi H Ghiasi F Sagheb H M Rashidi H Effects of vacuum compression therapy on healing of diabetic foot ulcers Randomized controlled trial Journal of Rehabilitation Research and Development Vol No 5 2007 Samy A K MacBain G Hutchison A S The use of vacuum compression therapy on ischemic lower limbs as assessed by changes in venous blood gases and serum lactate Vascular and Endovascular Surgery Vol 27 No 8 1993 Ghaderi F Bagheri J Effect of Vasotrain in Reducing Lower Limb Edema Medical Journal of Tabriz University of Medical Sciences No 60 Winter 2004 Larijani B Hasani Ranjbar S Overview of diabetic foot novel treatments in diabetic foot ulcer DARU Vol 16 Suppl 1 2008 Rithalia S V S Gonsalkorale M Edwards J Effects of vacuum compression therapy on blood flow in lower limbs International Journal of Rehabilitation Research September 1989 Volume 12 Issue 3 ppg 320 322 Brorson Hakan M Svensson Henry Liposuction Combined with Controlled Compression Therapy Reduces Arm Lymphedema More Effectively than Controlled Compression Therap
99. r 1 and put on the extremity If higher values of positive pressure are used it is suitable to connect the patient s chair and device with a fixation belt In application of usual values of positive pressure the brakes of device wheels 14 should be thoroughly applied At the end of patient s preparation for application of VCT procedure adjust slightly the position of the application cylinder by its minor lifting up UP or down DOWN or tilting These actions are performed using the remote control 11 In doing so you usually should stay at the neck of the application cylinder 1 and check whether the extremity is enlaced surrounded with the sealing cuff 9 along the sealing periphery fully uniformly i e the extremity should not press excessively the cuff at any place In this case the extremity is not sealed optimally during the procedure 4 4 Administration of Vacuum Compression Therapy Procedure Administration of vacuum compression therapy procedure is performed by means of control computer 12 with touch screen 13 in the manner described in detail in Chapter 4 2 The vacuum compression therapy procedures can be administered only according to regulations or recommendations of a physician regardless of pre programmed procedures and know patient s diagnosis The patient should be under the permanent at least remote supervision of a qualified medical operating personnel of the device 4 5 Completion of Vacuum Compression Th
100. r can also trench into the procedure during the administration of VCT it is also possible to change the parameters to ensure the most optimal conditions of VCT procedure Simultaneously the additional device ensures the duplicity of the databases of the administrated VCT procedure the possibility of improving the quality of the procedure s prescription composition of the procedures directly on the supervising PC and subsequently sending this to the control PC of the device It is also possible to analyse the results except the real time In order to use the telemedicine through the internet The prescription the special monitoring and the evalutation of the VCT therapy s results can be naturally provided only by the qualified doctor The proper VCT therapy administration could be provided only by the trained medical worker or physiotherapist or the doctor The using of VCT for recondition and sports purposes is possible only in co operation with the doctor At using the additional device type Pacient monitoring is possible to controlduring administration of procedure and control the paramtres of the procedure in two modes The first is a standard mode where it is not displayed the reaction of the pacient but only the overpressure and underpressure in the application cylinder The second mode will be invoked by pressing the click on the graph pictogram in left bottom part of the display Here are depictured the reaction of the pacient In left part
101. remote control of travels and positioning of cylinder 11 mains supply 26 accompanying documentation and the like Particular attention is be given to taking out the application cylinder 1 and its unpacking because this is a very fragile item Some parts such as the application cylinder 1 are not only closely packed but they are also within the transportation case firmly fixed using contracting bands that must be released These bands are usually released using double safety locks on their metal connecting carbine hooks The bands are not cut so that they can be reused if the device must be uninstalled and safely packed for any other transport Finally the transport case will contain a basic component of the device consisting of the base 3 with the vertical arch 2 computer box 12 and the horizontal cross member of linear travel 4 The basic device component is thoroughly fixed by contracting bands and the device base is firmly linked to the bottom of the case These connections must also be released by unscrewing the bolts The released base component will be taken out of the transport case and put on the travelling wheels 14 In handling and lifting the device use withdrawable holders 30 two holders in front and two holders in back For handling and lifting never use edges of plastic covers arch 2 control computer 12 and the like The holder near the control computer box 15 is used only to keep balance during manua
102. rs 1 to 5 is dedicated for pressure parameters of procedure with prevailing negative pressure especially for the treatment of extremities with trophic disorders perfusion disorders ischemia and the like This part of the table is marked in red as it represents an area of pressure parameters which have an impact mainly on the arterial system Caution You should not move between the specified three parts of the table during modification of pressure parameters of procedure during the procedure And now practical examples If after pressing the EDIT TABLE button you enter the table in order to modify pressure parameters of procedure we must first find the appropriate field relevant to the positive negative pressure applied so far In our case this field is 6 8 kPa This field can be easily found when you realize that the combination 6 kPa 8 kPa was created as a superposition of pressure intensity of procedure 6 6 and the type of treatment 2 prevailing action of negative pressure over the positive pressure by 2 kPa So you have to look in a column with the heading 6 6 and in row with a value of 2 We can find that we are at the bottom part of the table the bottom strip prevailing negative pressure For this bottom part of the table with prevailing negative pressure we can say that increase in power of action of procedure can be achieved after moving in a diagonal direction right down in moving
103. rtificate 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 device 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 operator operating this device without proper qualification and or training in its use 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 o A medical device must undergo regular checks of functionality and safety periodic inspections These inspections may be performed only and exclusively by the manufacturer or authorised service care provider o All service work on the device may be performed only by the manufacturer or authorised service care providers o From the viewpoint of legal requirements for complete traceability vigilance of medical devices the manufacturer of the device must know a final us
104. s a more frequent approach In some sensitive patients or patients with a very reduced venous flow when any transfer of a certain volume of blood between the body centre and periphery is very slow and specifically where low values of negative positive pressure must be selected you can advantageously use the deceleration of pressure changes After selection of all therapeutic biotropic parameters of user procedure the pre start page will appear where you can carry out any corrections or modifications of selected parameters or you can start the prepared procedure However you have another possibility namely to save into memory a relatively hard compiled custom procedure before its running Caution This is a different type of saving than saving the procedure to the Favourite Procedures folder Here the procedure is saved only within the folder User Procedures before the start of the procedure itself By pressing the Save Procedure button you will call up the following option of saving where only one arbitrary identifier is used The compiled user program with the parameters negative pressure 11 kPa positive pressure 7 kPa positive pressure duration 25 seconds negative pressure duration 15 seconds nature of procedure impact pressure changes fast 10 cycles are preferentially entered which corresponds to the procedure duration of 21 minutes will be saved with the identifier name ische
105. s following START Control Panel Sounds and Audio Device Properies Then we choose the intensity of the voice LOW HIGH or we can switch off the voice MUTE The voice intensity we can control also as following START AIl Programs Accessories Entertainment Volume Control C Entry to the internal memory of the control computer by the order COMMIT After all changes parametres calibration volume control etc is necessary to save all this into the internal memory of the control computer by the pictogram COMMIT on the PC sheet in OS WINDOWS EMBEDDED After this is necessary to restart the computer START Shut Down in the tab change to Restart then OK and then wait until the new application seizing D History of the procedures It is possible thereby D Database Data HistProc E Setting up off data and time of control PC START Control Panel Data and Time F The connection of the control PC to the Internet In case we want to connect the PC to the Internet first we have to connect the cabel LAN with the ending RJ 45 into the appropriate connector on the tablet under the box of control PC or directly on the control PC after the uncovering of the plastic shell Then we will start the Internet Explorer Application In case it is permissed the automatical set up of the protocol TCP IP it is not necessary to set up it manually Or if it is not pre set up we have to do this manually We open the offer of the wire setting Start My Netw
106. s reached 14 EXTREMITER 2010 BETTER FUTURE edition other sufficiently intensive values of therapeutic biotropic parameters of procedure are selected positive pressure negative pressure values and duration and there is no need to increase these values On the contrary these values may be decreased In the event that no colour changes are reached or these changes are not sufficient during the procedure then it is advisable to increase the values of the main therapeutic parameters if possible However it must be taken into consideration that during VCT application the optimal colour changes are most quickly and best expressed with healthy persons In patients with vascular disorders the required response may happen only after repeated procedures not immediately after administration of first procedures This colour change may be so small that it cannot be perceived by the naked eye but the procedure may bring the needed therapeutic benefit Therefore it is not appropriate to increase the values of particular parameters or even to replace a used therapeutic program for a more radical one immediately during the first procedures eventually to stop the administration of VCT procedures in case the colour changes on extremity are not visually visible If it is necessary to increase the parameters of VCT we recommend prolonging the positive pressure negative pressure phases first The pressure values of these stages are to be subsequentl
107. safe chain transmission Movement of the application cylinder 1 up or down is controlled by the touchscreen 13 of the control PC some models of this device could be remote controlled 11 position UP 11a position DOWN 11b The supporting arch of shark fin type 2 is anchored in a robust base of the device 3 Inside this base there are well arranged and positioned power and control elements of the device a special multi chamber compressor with a high performance pump power supply network section with a safety transformer of health grade and electric filters valve unit for high volume air flow with a long lifetime control electronics of power elements module with AD and DA converters with control microprocessor motor with worm planetary gear sets to ensure movement of the application cylinder toothed gearbox chain wheels and chain transmission linear guide of the supporting arch 2 electromagnet and steering rack of the brake pneumatic distribution systems air suction filter measuring and calibration points of electronics measuring and calibration points of pneumatics and the like The vertical supporting arch of shark fin type 2 can be easily relocated in the direction of the application cylinder axis in a length of approximately 300 mm The required position is perfectly fixed using a latch and steering rack whose stroke brake release and brake application functions are remote controlled by means of a powerful
108. se fixed with fixation boards and bands In addition the transport case must contain the Accompanying User s Documentation User s Manual The transport case must be properly marked 4 12 The operation conditions and storage The following storage conditions are to be applied Working till 40 C Temperature Storage 10 till 50 C Working 15 till 95 Relative humidity Storage 5 till 99 Working 425 till 809 mmHg Atmospheric pressure Storage 120 till 809 mmHg 4 13 Transport Transport cases with devices can be transported by common covered means of transportation without heavy shocks The device packaged in a transport case must be handled with care similarly as with fragile shipment side up do not exceed the permissible storage conditions 4 14 Parts of the device and expendable supplies The basic device with the removable app cylinder The control computer with the sheating 70 EXTREMITER 2010 BETTER FUTURE edition Application position chair Sealing cuffs from the natural rubber standard 6 pcs Screwed outlet of the sealing cuff valve Neoplene inlays standard 12 pcs Sealing stainless annulus standard 4 pcs Supporting plastic PMMA annulus standard 4 pcs Fixation belt for fixation of the pacient to the appl cylinder only by higher overpressure Bed rest to the application cylinder Overball into the app cylinder Remote control Line connector UPS power supply The
109. sed well proven procedures Intensity Favourite procedures Antiedemic treatment and edema prophylaxis Intensity VERY EXTENDED z E 2 Intensity Combined arlerio venous disorders recondition regeneration and rehabilitation Intensity VERY EXTENDED 5 A Intensity 9 Peripheral arterial and capilla circulatory disorders and stagnation of metabolism of the arterial or capillary origin related trophic disorders in limbs improvement of pharmacological drugs efficiency on periphery elc Intensity VERY EXTENDED g E 2 E Intensity EXTENDED BETTER FUTURE edition EXTREMITER 2010 30 2 7 3 Contraindications of Vacuum Compression Procedures Vacuum compression therapy is demonstrably a highly effective form of physical therapy applicable in many fields of medicine As every really effective therapy it also has some contraindications risks and possible side effects Knowledge about them is developing for example new unknown contraindications may appear or on the contrary some current contraindications may be shown as too strict or unnecessary It is the natural duty of the user of this device and a responsible organisation to follow the development of this knowledge throughout the use of the device According to the current professional medical knowledge the following conditions are considered to be
110. selected procedure 4 2 4 Well Proven Procedures From the basic menu by pressing the button Well Proven Procedures you can proceed to this folder Here you have exactly the same pre programmed procedures which were introduced and by a long standing practice extensively verified on the original production version of the Extremiter unit These procedures are divided into three groups For prevailing arterial circulatory disorders and mostly arterial respectively capillary conditional stagnation peripheral metabolism and for related trophic disorders of extremities improving the effectiveness of pharmaceuticals on the peripherals etc i e procedures with prevailing negative pressure over positive pressure see the red fields of pressure parameters of the modification table EDIT TABLE For combined disorders with marked arterial and venous elements also suitable for general reconditioning regeneration and rehabilitation purposes i e procedures with an ideal balance of negative pressure and positive pressure see the green fields of pressure parameters of the modification table EDIT TABLE For antioedematous use and prophylaxis of oedemas i e the procedures with values of positive pressure over negative pressure see the blue fields of pressure parameters of the modification table EDIT TABLE A particular group of procedures can be called up by pressing the OK button for example 1 from the given groups According to t
111. sity is too high or to low and there where we are not successfull for example the extremity swells to much Let us show now how to modify positive pressure and negative pressure values in the running procedure Here the main problem is that the procedure chosen from the folder Procedures According to Diagnoses or from the folder Well Proven Procedures and Special Procedures has established a certain optimal therapeutic combination of positive pressure and negative pressure So if you want to increase or decrease the intensity of procedure action during the procedure you can not just change the positive pressure or negative pressure but you must maintain a certain combination of action of both these factors a so called direction of treatment or sense of treatment or orientation of treatment Further let us consider that if you act only with symmetrical values of positive pressure and negative pressure for example 5 kPa 5 kPa you could talk about an increase in intensity of action if these values are increased For example intensity 6 kPa 6 kPa is naturally greater than intensity 5 kPa 5 kPa The following table shows these intensities in the upper header of table columns This approach will however not consider the fact that for the intended therapeutic action we need a prevailing negative pressure sometimes arterial problems problems with perfusion ischemia cold extremities etc and in
112. so eliminate the consequences of an increased blood viscosity or reduced elasticity of erythrocytes and at the same time they support nutrition oxygenation and exchange of metabolites The above mentioned features of VCT lead to effective and in other ways hardly achievable possibilities of the physically therapeutic influence of circulatory disorders in cases of macro angiopathy mini angiopathy and micro angiopathy of various aetiology disorders of capillary return of neurogenic origin other disorders of peripheral capillary return trophic disorders pressure related disorders in extremities as well as some types of lymphatic oedemas post traumatic states algodystrophic syndromes serious systemic diseases such as diabetes mellitus stress syndromes aging related changes degenerative changes in tissues of extremities primarily their movement system such as arthrosis and their skin cover for example trophic defects and the like Vacuum compression therapy may also be utilised for general rehabilitation reconditioning preventive sports and cosmetic purposes Contraindications are primarily actual and potential thrombosis suspicion of thrombosis development risks of bleeding risks of infection or metastasis dissemination and serious cases of cardiac insufficiency associated with cardial oedema or more precisely the edemas of the hepatic origin In its therapeutic indications vacuum compression cannot be fully substituted w
113. surisation 20 from the orifice of the sealing cuff 9 This will release any residual pressure from the cuff Then do not let the patient himself herself to slip out of the application cylinder 1 but using the remote control and electromagnetic brake release the travel of supporting arch 4 and application cylinder 1 from the patient s extremity If the movement of app 30 cm was not sufficient release the locking handle 5 of linear travel 4 and continue in shifting away the application cylinder 1 If so requested by situation open and take away the cylinder bottom 27 and handle the extremity from this side Finally take out the treated extremity through the neck 8 of the application cylinder and leave the patient to relax for a certain amount of time Then continue with treatment of the other patient s extremity or treatment of other patient However you must clean and disinfect internal areas of the application cylinder 1 first sealing cuff 9 or other parts of the device which may come into contact with the patient s body It is the responsibility of a physician or a qualified and responsible health professional to decide about disinfecting requirements Note The application cylinder 1 can be removed from the patient s extremity also by travelling with the patient s armchair in the back direction or movement of the entire device in the forward direction the wheel brakes must be released Note In drawing
114. t bottom part of the display monitor there is a significantly STOP button intended to stop the running procedure In addition the blue fields show the maximum applied positive pressure and negative pressure The button with the symbol of straddle truck which opens the control of positioning of the app Cylinder 1 its movement up UP down DOWN tilting on one side and on the second side and brake release It can be needed to decrease or increase the pressure during the procedure or to change the parametres of the procedure To this purpose there are two buttons on the bottom ledge PRESSURE 52 EXTREMITER 2010 BETTER FUTURE edition MODIFY and TIME MODIFY After opening of the mod menu the process is clear Attention Actual procedure will be with original pressure and time parametres In terms of the option of PRESSURE MODIFY it can be ignored the individual increasing and decreasing of the over and underpressure and the user can go straight to the systematical edit Table EDIT TABLE The sense of this table is following Each therapeutic VCT procedure has got an optimal combination of underpressure and overpressure In case we would like to change the underpressure or overpressure parametres we have to retain the effect of prevalent combination by incidence of both factors For this purpose we can use the button EDIT TABLE It is possible to use it there where the combination of these factors will be retained but the inten
115. tandard part SW equipment of the version 2 of the control computer It serves as a significant super structure it supports the remote supervision of administrated procedures and treated pacients We will press the button on the bottom edge of the monitor to start the adequate database on the control computer The database rises by writting parametres after the procedure ldentificators are the datas about the pacients the datas about the administrated procedure and its treating effects 4 2 9 The operating of standard PC functions A Calibration of Touchscreen It is necessary from time to time to carry out the calibration which ensures that the place of the touch responds exactly to the point on the flat For this purpose the computer is equipped by a special calibration program which you can start as follows Start All Programs PenMount Universal Driver PenMount Control Panel After the startup we click on the pictogram of the pencil PenMount 6000 ISB and press the button Configure Then we press the button Standart Calibration After this we have to touch by the help of Stylus in some point of Touchscreen Caution After the calibration process we have to save this into the internal memory of the PC we click on the pictogram COMMIT in OS Windows Embedded and after restart the PC and wait for the new application seizing EXTREMITER 2010 BETTER FUTURE edition 61 B Volume control The Loundspeaker volume we can set up a
116. the application cylinder bottom 1 resp its re fixing and sealing Internal supporting removable circular rings used for fixation of the sealing cuff 9 in the neck 8 of the application cylinder 1 from application area The assembly consists of 4 pieces with internal diameters of 12 cm 14 5 15 cm 18 cm and 21 cm External closing removable circular rings used for fixation of the sealing cuff 9 in the neck 8 of the application cylinder 1 placed on the edge of the cylinder 1 towards the patient and secured by turning The assembly consists of 4 pieces with internal diameters of 12 cm 14 5 15 cm 18 cm and 21 cm Insertion piece of cuff pressurization Insertion pieces of hoses and incoming pneumatic connector of pressurization 21a vacuum application 21b of the application cylinder 1 Circular pegs 3 pcs located at the periphery of the application cylinder neck 1 on which the external removable circular rings 19 are to be placed secured by turning Stops of linear travel of the application cylinder 1 in the direction of its axis To the right 23a to the left 23b EXTREMITER 2010 BETTER FUTURE edition 39 24 Fixing handles of arms 24a to the right 24b to the left after their release by means of the holder 16 the closing arms 7b can be tilted off and after releasing the hoses the a application cylinder 1 can be removed 25 Appliance inlet of electric power supply intended for insertion
117. the extremity out of the sealing cuff 9 it is necessary to take care and do not deform or damage the cuff The cuff can excessively adhere to the extremity during the procedure Therefore before the procedure it is advisable to treat the contact cylindrical surface of the cuff 9 with the extremity with a suitable agent for example cosmetic glycerine In the course of loading and removal of extremity the cuff must always be released from the extremity 4 6 Operation of the Device in a technical Service Calibration and Control Mode The device EXTREMITER 2010 BETTER FUTURE manufacturing edition includes very advanced technical service calibration and control modes realised by modern automated hardware and software technologies Any intervention with these modes can be performed only by the qualified expert who was demonstrably trained and authorised by the manufacturer of this device and equipped with necessary technical means Any unqualified interference with these modes leads to the risk of damage to the device and a potential danger to the patient For the device EXTREMITER 2010 BETTER FUTURE manufacturing edition one year regulatory time period is prescribed to perform protocolar checks of trouble free functionality recalibration and full safety of this medical device The computer memory also contains all given procedures and their parameters as well as related reports of the control unit throughout the life of
118. tiology Application of VCT may also contribute to better circulatory condition of the patient client Fig 1 1 Example of application of vacuum compression therapy administered by the device EXTREMITER 2010 BETTER FUTURE edition applied on the lower extremity Fig 1 2 Example of application of vacuum compression therapy administered by the device EXTREMITER 2010 BETTER FUTURE edition applied on the upper extremity Procedures of vacuum compression therapy administered by the device EXTREMITER 2010 BETTER FUTURE edition are applied mainly in the following branches of medicine Therapeutic rehabilitation and physiotherapy opa sector balneology Diabetology Angiology vascular medicine Phlebology Lymphology Neurology Orthopaedics Traumatology accident medicine Surgery especially vascular surgery Internal medicine Preventive and reconditioning medicine Anti aging medicine Sports and cosmetic medicine Vacuum compression therapy VCT is based on the alternation of negative pressure and positive pressure phases in an application cylinder where the treated extremity is hermetically sealed and subsequently exposed to a controlled action of hyperbaric overpressure and hypobaric underpressure environments Therefore vacuum compression therapy is based on the action of alternating hyperbaric and hypobaric environments to a treated lower extremity or alternatively to a treated upper extr
119. tion schema you can see that the ground of the technical solution of the additional device type CO2 Therapy edition Better Future is the control and mixing unit which ensures the mixing of carbon dioxide with the air on the requiered and indicated concentration see the display concentration measurement and control in the bottom part of the unit so the disinfection of the recycling mixture of the air and carbon dioxide in the requiered concentration This basic unit of the electronic controlled mixing unit regulates automatically the supply of the fresch medicinal carbon dioxide from the pressure tank CO2 bottle The pressure on the output with CO2 is appropriately reduced by the safety two stage reduction valve its output is by the staff manual adjusted on the pressure circa 0 2 till max 0 5 bar The pressure tank with carbon dioxide can be transport only with properly ensured by the safety way see 18 EXTREMITER 2010 BETTER FUTURE edition the picture the trolley with the chain and by the same way should be ensured the pressure tank on the place with the device for vacuum compression therapy Low pressure hose connections connect the tank pressure with control and mixing reservoir and the mixing reservoir with the own device for vacuum compression therapy In case the device is provided by the HEPA filters class P3 than are these filters screwed up and into their connection places are putted the hoses from the mixing reservoir
120. to insert firmly and press the insertion piece of cuff pressurisation 20 into the orifice of the fixed sealing cuff Caution The cylinder neck assembly is more practically implemented if the application cylinder 1 is in a slight elevation it means that its neck 8 is in a slightly upward position In this position of the cylinder 1 the inserted elements of the cylinder assembly do not slide out of the neck Now insert the patient s extremity to the cylinder neck 8 and put the application cylinder 1 on the patient s extremity by travel of the supporting arch 2 or superposed travel of linear guide 4 Caution Do not forget to apply the brake by the remote controlled electromagnetic brake on the travel of supporting arch 4 position BRAKE OFF as well as secure the locking handle 5 of linear guide 4 Also check that the brakes of travelling wheels of the entire device are applied Note If in some cases it is better to travel with the entire device to the patient and insert the treated extremity into the application cylinder 1 in this manner it can also be used without problems First release the brakes of all 4 travel wheels 14 lift up the patient s extremity in the direction of cylinder neck orifice 8 travel back with the entire device first in the direction from the patient s extremity then towards the extremity Movement with the entire device before putting the extremity into the cylinder neck should be perf
121. transition from one phase to other In the case of combined arterial and venous disorders the usual values of positive pressure negative pressure range from 3 up to 6 kPa In the case of mostly arterial disorders this negative pressure can be set within the range of 6 kPa up to 12 kPa The stronger negative pressure is selected only in exceptional cases such as scleroderma and more serious stages of arterial disorders with certain complications In such cases however all relevant risks and contraindications of VCT must be carefully considered Higher values of negative pressure are also often connected with worse subjective toleration by the patient The amount of negative pressure especially its duration is usually selected so that the rising passive hyperaemia would be able to extend into the tips of the extremity during this negative cycle phase In the event of bad tolerance and risks of using the higher value of negative pressure this pressure can be reduced to below its usual value and partially compensated by a longer period of its action In antioedematous therapy the positive pressure can be increased up to the values ranging from 6 kPa up to 10 kPa The positive pressure is used to be better tolerated by the patient but theoretically its risk mainly thrombosis is the same or even higher than the risk resulting from the negative pressure application The combination of higher positive pressure with lower negative
122. triment might be caused EXTREMITER 2010 BETTER FUTURE edition 9 Special warnings 10 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 The 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 contact with this device or its parts could not cause any risks to the patient or other persons coming to contact with this device 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 a cylindrical applicator of the device must be performed carefully in order to prevent from injury of the patient Fixation Dual type handles fixing the cylindrical applicator in its fixing yokes 24 in a selected horizontal position 5 must always be sufficiently tightened The electromagnetic brake of the supporting arch feed must be applied in the course of procedure administration see the remote control OFF position 11bb The travelling wheels 14 must also be braked It is necessary to check regularly the integrity of all device parts in particular electric cables pneumatic air distributions systems application cylinder and plastic laminate covers device encapsulation Non original parts must not be us
123. turn sometimes we need a prevailing positive pressure such as oedemas and sometimes only a mere equilibrium symmetry of positive pressure and negative pressure is a really optimal option Therefore a new variable called Type of Treatment is established This variable will characterize whether the predominance of positive pressure or negative pressure is required as well as how strong this dominance should be Negative values will reflect the predominance of negative pressure and the more negative this value is the more negative pressure will prevail over the positive pressure Positive values will reflect the predominance of positive pressure and the more positive this value is the more positive pressure will prevail over the negative pressure In fact the term Type of Treatment is the number which will be added to the value of positive pressure if positive or added to the value of negative pressure if negative at a selected intensity of procedure By combination intensity of procedure and type of treatment you will get a table with 121 fields where each field represents a certain combination of positive pressure and negative pressure EXTREMITER 2010 BETTER FUTURE edition 53 The following table will appear on the display of the control computer TP Fe 8 THEBHEH TT TT BEBE MN HEBREE MM INN BETTER FUTURE
124. ubiti Alloplastica Achillodynia pue Aseynasea Jo 333443 INNadesayy esouDeip UJIM 59100920 gt B o a S 3 o 5 E Ed S a gt 0 a Group 6 Vertebrogenous algic syndromes with projections to the upper extremity or lower extremity asoubeip 9099106 4 uonoaloid suenpenqoaasao 6 seuro1pu s 2162 1 10 ayy EXTREMITER 2010 BETTER FUTURE edition Group 7 proximal distal proximal 8 3 Oedematous conditions nsistence elastic consistence elastic consistence advanced beginning hard difficulties benign difficulties with a manifestation of malnutrition 1 I of malnutrition E 58 EXTREMITER 2010 BETTER FUTURE edition Secondary With advanced venous Swith varices with no organic chang Subchronic Without inflammatio With inflammation Subacute euiapaotudui ajeydu j 10 2I ejS0U2A 0 paurquio esouDeip 4 suoimipuoa 25 Group 8 Post traumatic and post surgery conditions 26 Subchronic 5 8 2 4 radical t
125. upply battery of 235 type 12 V Check whether the application cylinder 1 moves in a safety area and using the remote control check the travel MOVING along the vertical supporting arch 2 UP and DOWN as well as tilting the application cylinder TILTING to one side and other side UP DOWN as well as brake release of the entire vertical arch BRAKE ON its manual transfer to the right and left extreme positions and brake release BRAKE OFF During manual travel with the entire vertical arch you must check whether the arch is released When moving with the cylinder 1 use the holder 16 preferably Caution Neither lift the holder 16 upwards nor tilt it in the direction of closing arms 7b as this will result in forcible extraction of arm fixation handle 24a 24b If all these checked functions of application cylinder 1 positioning work fully reliably you can also check the manual feed of the application cylinder 1 using a linear horizontal travel 4 in the direction of the cylinder axis In doing so hold the cylinder holder 16 and travel very carefully to prevent from damage the air supply hoses leading to the cylinder bottom 27 and cylinder neck 8 as well as prevent from hitting the stops of linear horizontal travel 23a 23b Manual travel of the application cylinder 1 by means of the linear horizontal travel 4 should also be checked at the tilted cylinder In this case however you must firmly hold the cy
126. uracy of the cuff by preliminary putting the sealing scuff 9 on the extremity At the point of sealing the extremity the cuff should enclose the extremity closely but still slightly The internal cylindrical surface of the cuff 9 can be treated with cosmetic glycerine This will increase the life of the cuff and facilitate its putting especially on a haired extremity Please not that the glycerine EXTREMITER 2010 BETTER FUTURE edition 63 however can get dry after a certain period of time At certain leakages between the cuff and extremity at the point of its required sealing you can also make use of simple or coaxially compound neoprene rings The sealing cuff or neoprene circular rings as well as all internal space of the application cylinder 1 must be properly cleaned and disinfected If it is necessary to ensure a high level of hygienic separation of the treated extremity from the internal environment of the application cylinder 1 and from the sealing cuff 9 a long narrow protective bag can be put on the extremity first which covers the whole extremity and overlaps from the neck of the cylinder For this purpose narrow micropore bags are usually used but they can not be considered as means of sterile separation but only as hygienic aids Special silicone sterile sleeves are purchased only in the event of specific requirements Practically any cover on the extremity prevents the diagnostically significant observance of co
127. use the following example for the selection of Peripheral Diabetic Complications Other level of hierarchic selection will appear You will treat for example Diabetic Sensomotoric Neuropathy EXTREMITER 2010 BETTER FUTURE edition 47 more severe condition 48 EXTREMITER 2010 BETTER FUTURE edition A selection of biotropic parameters of appropriate therapeutic procedure will appear a so called pre start condition LL k fec py 4 TVT ZA py F T KOZY V A 5 A i Zalll ait 4 p I tha gt MENU therapeutic procedure with tne Tollowing parameters wil be initiated Proceeding of the procedure Velocity of pressure changes Overpressure Underpressure Time of underpressure s Time of overpressure s Pressure units change Number of periods where you can choose to show pressures in kPa or in mmHg see the buttons marked mmHg or kPa All proposed therapeutic biophysical parameters can also be modified see next By pressing the button in the upper right corner of the display you can display technical and application parameters of a selected procedure including the recommended number of procedures in series therapeutic series in a year and the like EXTREMITER 2010 BETTER FUTURE edition 49 Overpressure Underpressure Number of periods C
128. utually threaded stacked up and you can achieve a higher wall thickness of built up neoprene ring Use of neoprene rings is suitable also in patients with increased sensitivity to pressure of inflated sealing cuff around the extremity Neoprene rings however cannot replace inflatable sealing cuffs of necessary internal diameters Let us go back to the demonstration and testing assembly in the cylinder neck At this moment we will not disassembly it but it will be used for the pressurization vacuum application test of the application cylinder 1 Insert the insertion piece of cuff pressurization 20 into the orifice of sealing cuff coming through the opening in the cylinder neck 8 and secured by a screw nut Connection is secured by the cone therefore the hose with the insertion piece should be only put into the orifice of the sealing cuff and slightly pressed down This solution is not only very quick in real situations but also enables at any time during the therapeutic procedure if necessary to complete pressure vacuum action on the patient s extremity only by a slight withdrawal of the hose insertion piece from the cuff orifice Caution very important While any manipulation with the device especially at tilting and following covering of the holder 16 of the app cylinder it is necessary to watch out that the hose of the air supply will be not damaged This hose is important for measuring of the pressure in the seali
129. vice must have available information provided by this users manual or other information provided within the framework of training for operating personnel or in connection with other utilisation of the device EXTREMITER 2010 BETTER FUTURE edition and applying the physical and therapeutic method of vacuum compression therapy In using this device within the framework of health care service provision a particular 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 e purposes other than the intended purposes of use e inan external environment in an environment with the increased risk of electric shock for example humid or wet environments or environments with moving and unsecured mechanical substances in an 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 e 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 de
130. visualized After this is possible to press the START button again The process has to find out the starting volume of the extremity than will be possible to measure while administration of VCT procedure the changes of this volume In case we want not or we could not measure the extremity volume while administration of VCT it is possible to pass the process you will press the START button after not the OK button but again the START button and the VCT procedure is starting In case you need to realize the modification of parametres you have to press and hold long the button with the symbol lock EXTREMITER 2010 BETTER FUTURE edition 51 The unlocking enables to modificate the parametres of the procedure For example the 30 minutes procedure which contains 16 vacuum compression cycles periods we will changed the procedure to 10 cycles periods which will take cca 18 minutes By the press of the START button we will start the procedure In the upper part of the display monitor there are displayed four numerals gradually from left to right they mean pressure in the sealing cuff 9 pressure in the therapeutic application cylinder 1 number of cycles periods during the procedure this time is decremented and procedure duration during the procedure this time is incremented The large green framed area is intended to draw a graph of positive pressure and negative pressure course in the application cylinder 1 depen
131. xtremity however especially if slim directs mostly through the cylinder neck sidelong downwards out of axis of the application cylinder 1 In this manner the sealing cuff is unnecessarily pressed in the cylinder neck 8 under the extremity and there is created an opening above the extremity and automatics of the device cannot easily seal this opening Under this situation only partial success can be achieved by tilting the application cylinder 1 using the remote control 11 In these cases it is necessary to pad out a distal part of extremity usually hand and forearm after its insertion into the cylinder 1 For this purpose partially inflated exercise balls of suitable sizes are very convenient Distal part of the extremity sinks into these balls and the extremity is well positioned in the application cylinder This procedure mostly does not put increased requirements for the operating personnel because a partially inflated smaller ball can be inserted into the application cylinder 1 before insertion of the treated extremity and the patient if he she can move with the extremity will put the extremity on this small ball by himself herself If the patients ability to move the extremity is considerably limited it is necessary to open the cylinder bottom 27 and pad out the extremity Various diagnostic sensors of biological quantities and the like are also inserted through this opened bottom 27 of the application cylinde
132. y Alone Plastic and Reconstructive Surgery 1998 102 1058 1067 Pr cha J Remission spectrophotometric measurements with optical sensor and practical analysis of acquired signals Message for International Haemodynamic Society USA 1999 Stvrtinov V Prekopov E Bozek L MatouSek P Pr cha J Vakuov kompresn terapie nova nad je pro diabetiky DIAS odborny zdravotn cky Casopis pre diabeticku a diabetologicku verejnost vydavatel DIAS s r o Bratislava SR ISSN 1336 9822 Cislo 6 2007 Pr cha J Pitr K Z hlava J Zabran J Vacuum Compression Therapy Haemodynamic Therapeutic Rehabilitation Method 5 th International Conference on Haemodynamics of the International Haemodynamic Society EXTREMITER 2010 BETTER FUTURE edition 33 Cejkovice CR 18 20 5 2000 Tomanova J Resl V Pr cha J Mo nosti l by flebologick ch pacient vakuov kompresn terapi Flebologick kongres Praha 2001 Pr cha J Pitr K r mek B M e byt vakuov kompresn terapie vhodnou procedurou t pro p zniv ovliv ov n kardiovaskul rn ho apar tu Konferen n p sp vek na Sjezdu Spole nosti rehabilita n a fyzik ln medic ny Luha ovice 2002 Pr cha J ed Sborn k p edn ek semin e Nov poznatky ve fyzik ln l b perifern hemodynamiky a l ebn rehabilitaci kon etin Spole nost pro rehab a fyzik ln medic nu esk angiologi
133. y increased gradually and always with care A limit for the selection of VCT parameters should be based on the individual condition of a particular patient with respect to the condition of his her vascular bed and in relation to contraindications and possible risks of VCT Attempting to reach the optimal colour changes is not the only criterion for effective and safe VCT During the VCT procedure the importance of cyclic application of a positive pressure phase preferably longer must not be left out of consideration The purpose of this positive pressure phase is in particular to force out the blood volume or lymph or tissue liquids taken in during the previous negative pressure hypobaric hyperemising phase so that this blood may be replaced by a new volume of fresh blood bringing oxygen or other necessary nutritional substances or pharmaceuticals in a subsequent cycle of VCT So failure to meet this requirement may act against the principles of VCT For objectivisation of administration of VCT procedures is the watching of colour changes of the treated extremity very indispensable but only feeble aid There is a device which called Pacient monitoring see further which is an optional additional device for VCT therapy type Extremiter 2010 Better future edition It enables to create such as variant of the device which provides the possibility to watch the immediate reaction of the pacient on the administrated procedure of

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