USER MANUAL
Contents
1. PHYSIOTHERAPY FUNCTION M T D From main menu press button Then press button M T D Cancel Setting oet up of device is now ready V 0000 1 1 0000 Z 0000 Sutton M come back one step ka Cancel Setting G3 5 Sutton E clear partial time ROTA OUS LAO EREDI CRUS E 00 50 Button Decrease power of transducer 2 o uA t0000 0 Button Increase power of transducer Button suspend treatment Here below lists of default values used by device for various pathology to begin treatment Treatment Port Modul Duty P PATHOLOGY Duty M 9 ra Time min KHz Hz 96 VEDE P Conveving Active Ingredients lio 400 Ay AO 50 Scars 15 400 42 40 50 Treatment of Pain 20 400 33 100 Attention At the end of each treatment clean transducers before putting into compartment e DX ane s is Am Forts Note Treatment time indicated is indicative and dependent on treated surface More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual 41 NEUROKINESI HERAPY N M F SUPERFICIAL From main menu press button N K T EZ Button come back one step MAIN MENU Cancel Setting Then press button Press button P A T Button come back one step MAIN MENU Cancel Setting Sele2. USER MANUAL J a GLOBAL THERAPY Thanks for having choose Dynamix nsure to read all instructions carefully for optimal performance of device and store them in a way that anyone who uses the product will be able to consult Manufacturer reserves the right to modify technical specifications in this Manual at any time and without notice Use only original accessories Only original accessories are specifically designed and certified by manufacturer for use with DYNAMIX If you use other kind of accessories from other manufacturers the DYNAMIX could be damaged and void the warranty It is strictly forbidden to reproduce transmit transcribe insert in a retrieval system of information translate into any language in any form or by any means even partial of this manuals supplied with this device without written permission of the manufacturer Notice for European User A This symbol means that electrical and electronic products have to be disposed in the appropriate waste containers his instruction Is applied only to users in European countries This product must be disposed in the appropriate waste container Do not be disposed with Nousehold garbage A differentiaded collection and recycling help to conserve natural resources and prevent negative consequences for human health and the environment which might be caused by improper disposal or more intormation please contact your local authorities responsib
3. insert connector into the socket placed on the rear panel of device aligning the arrow with the groove in the connector panel by a slight force up to the end of connector For disconnect the appliance simply unplug connector from the panel Attention Before connecting device to accessories make sure of mechanical integrity of the connector and the accessory bw H P E 9 e wj SRO Pa FIRST START Device does not require preliminary calibration Move general switch to 1 After just switch on device will perform a test of the FIG 1 Internal functions displaying the first screen of FIG 1 Dynamix hi ibilitation After initial test if anomalies are not found on the FIG 2 screen will appear Figure 2 and device is ready for USC FOr corect USS Of device refter to ine following chapters In case test detects an error it will be show screen of FIG 3 indicating error code For a full list of errors see Appendix G Dynamix LA 2016 CODICE ERRORE 13 Device overview 5 INTRODUCTION Diathermy Mechanics is a non invasive treatment generated through emission of ultraso unds able to produce a temperature rise in tissue depth of approximately 3 cm through conversion of a source of non thermal energy into heat within tissues Diathermy Mechanics Energy created by the passage of the acoustic wave across the fields of compression and rare
4. TOXICOSIS Edema Attention At the end of each treatment clean transducers before putting into compartment Note More information on diseases treated Therapeutic cards etc 33 are available on CD attached to this Manual Note 34 PHYSIOTHERAPY FUNCTION D A C U MANUAL From main screen press button F T R Then press button MAIN MENU Cancel Setting Press button cuo lt lt MAIN MENU Cancel Setting come back one step oet up data with buttons if and gt cuo M MAIN MENU Cancel Setting Button gt forward one step fi ana hen confirm selection with CONFIRM Button MAIN MENU Cancel Setting come back one step Set up data with buttons come back one step oet up of device is now ready N MAIN MENU Cancel Setting to begin treatment come back one step 35 ALTRE COMIROLADIA DCm 6 16 18 As 16 16 IO 9 its IE Z Va 10 10 2 14 DCp 30 40 30 40 Zi 50 60 SO 60 50 40 40 40 40 40 40 40 40 40 Tmr Clear partial time Decreases power to transducer Button Button lim Button Increase power to transducer nd treatment SUSDE Here below lists of default values used by device for various pathology Stop RS 5 iW 12 20 14 14 14 14 1 8
5. When you make applications on spine of patients with an outcome of laminectomy for possible damage to spinal cord It is possible to expose with ultrasonic areas with metal implants but only If you are sure that they are only made of metal Ultrasound also must never be applied in presence of Osteoporosis to high turnover Metallic fragments Prosthesis to limbs Varicose velns Phlebitis and thrombophlebitis Pace maker Vascular occlusive disease Haemorrhage menstruation Neoplastic tissues and surrounding areas uberculosis Ultrasound also must never be used on Pregnant woman During growth phase children adolescents Patients who are clearly unable to communicate to the therapist any painful sensation SIANDARD METHODS OF TREATMENT Basic protocol for Diathermy mechanics is essentially based on four steps Applying a gel not saline on the part to be treated 16 Put handpiece on the area with slow and circular movements along muscle fibers Duration depends on the treated area and protocol in use Hemoving gel by cleansing and application of special creams Making a drainage of treated area with discharge to the nearest lymphatic gland REFERENCE 1 Roger J Allen PhD PT Physical Agents Used in the Management of Chronic Pain by Physical Therapists Department of Physical Therapy University of Puget Sound 1500 North Warner CMB 1070 Tacoma WA 98416 USA 2 F Tabatabaie and
6. 5 SIORE IN A DRY PLACE TEMPERATURE LIMITS CODE SERIAL NUMBER THIS SIDE UP POSITIVE CONTROL DO NOT USE IF PACKAGE IS DAMAGED DIVERSIFIED DISPOSAL AC POWER g BS E nt 4 5 9 Mc e 8 p L 0 PER cities id ha nidi be um dd 7 Digs P d m mo x 0 1 E n F 0 M a BU S BEG SML EM CE TIS 7 2 o 1 N IG SET JH M yi NS Ar x n 1 A af oe APPENDIX E Packing and Shipping Choose an appropriate size and type of packaging in weight shape and nature of contents of shipping During operations of transport and distribution containers not adeguate or filled in insut ficient or excessive way may deteriorate or open It is recommended use high quality packing material to protect contents of your shipments 0 shipments that travel along with them shock and vibration and also from possible exposure to ad verse weather conditions Boxes available in various materials sizes and accessories for closure are most widely used type ot packaging Attention Use original packaging is a great way to ensure an expedition protected from bumps and accidental damage m _ t 5 T1 TECHNICAL ASSISTANCE APPENDIX F Technical Assistance List of Authorized Service Centres AWB S r l Strada del
7. MANUAL From main menu press button Then press button MAIN MENU Cancel Setting Press button Button come back one step MAIN MENU Cancel Setting oet up data with buttons and Button come back one step MAIN MENU Cancel Setting Button gt R forward one step Set up data with buttons and a Then confirm selections with Button come back one step MAIN MENU Cancel Setting oet up of device is now ready Fress to begin treatment Button come back one step MAIN MENU Cancel Setting Butto 4 Decrease power of transducer 2 2 di ev a 25 Dutton y Y Increase power of transducer NEY H QUEE 1 t 0000 7 0000 Uton ouepena E v I 3 Here below lists of default values used by device for various pathology Treatment Port Modul Duty P Duty M FAMILY PATHOLOGY Time min KHz Hz Low back pain ta 0 0 42 40 50 Lumbar sciatica 16 400 42 40 56 FRAXEL Myofascial pains 6 400 42 40 50 edema 5 400 42 40 50 Muscle contractures 20 400 33 Mine ah HYPERTHERMIA Muscle fibrosis 20 400 So 100 Attention At the end of each treatment clean transducers before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual 40
8. 2 Device Visual inspection and functional MP 58 Fuse replacement should take place when one or more fuses are damaged Intervention interruption of fuse normally occurs in the early stages of activation or deactivation of system due to overcurrent Note Electrical and mechanical characteristics of the fuse can be found on rating plate on the back of machine For reolacement proceed as follows Using a screwdriver remove cover of fuse seat Remove fuses that are placed on the rear side of the cover Insert new fuse on the rear side of the cover Heplace cover on the switch Attention Before proceeding make sure to have switch off the device and disconnect power cable from network jack Attention Use of fuses with not appropriate electrical characteristics can irreparably damage the device In this case faults are to be considered out of warranty L p Se 59 60 e p gt EP O N s 2 P cc U TEES APPENDIX A Technical Specifications DESCRIPTION U M VALUE General Section Input Voltage Vac ino 250 Input Frequency Hz 50 60 Dimensions cm 450x310x140 Weight Kg 4 5 Operating Temperature from 5 to 40 otorage Temperature AG from O to 50 Functioning EN60601 1 Continuous Classification of overvoltage category EN60601 1 Warranty Years 2 Hazard Class EN60601 1 I B Directive MDD 93 42 CEE class lla D
9. 20 eZ 16 14 14 10 18 16 Start lo 12 T2 20 T 14 14 12 20 16 14 14 10 18 16 E E EDU OSES FAMILY PATHOLOGY Arthritis rthrosis Adhesive Capsulitis Morbo em ios LP A TE E Galcifications Tendon Osteophytosis Superficial E gui mr gres AE in Tendinitis lendinosis Fasciitis lendinopathies DCm 8 9 14 14 2 E 10 2 9 HE 20 10 10 9 15 36 Start Stop Tmr DCp 2 IE 40 10 ie 40 8 8 40 10 IO 40 e 12 A iS ilo 40 10 10 40 16 16 40 iz 6 16 16 30 12 2 SO 18 18 40 ke iz 40 16 16 SO ii 12 30 FAMILY PATHOLOGY MODE ouperficial 5 Deep Distraction Muscle Superficial Contractures Deep 085 ouperficial Tendon Deep Superficial Distraction Ligamentous Deep Superficial Ematomatose Deep Superficial Acidosis Deep TOXICOSIS Superticial Edema Deep Attention At the end of each treatment clean transducers before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note p ucc ct Sr ES More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual PHYSIOTHERAPY FUNCTION C A D FRAXEL From main menu press button Then press button ETE MAIN MENU Cancel Setting ress burton 115 55 come back one st
10. A Mortazavi Studying the Effects of Ultrasound Shock on Cell Wall Permeability and Survival of Some LAB in Milk studying the Effects of Ultrasound Shock on Cell Wall Permeability and Survival of Some LAB in Milk 3 Steven H Dayan MD Amil R Shah MD Tapan K Bhattacharyya PhD Kevin O Grady BS Shridhar Ventrapragada MD Effect of Low Frequency Ultrasound on Epidermal and Dermal Structures A Clinical and Histologic Study 4 P Palumbo B Cinque G Miconi C La Torre G Zoccali N Vrentzos A R Vitale P Leocata D Lombardi C Lorenzo B D Angelo G Macchiarelli A Cimini M G Cifone and M Giuliani Biological effects of low frequency high intensity ultrasound application on ex vivo human adipose tissue Department of Health s Sciences and Department of Basic and Applied Biology University of L Aquila 6 100 Coppito L Aquila Italy 5 Timothy G Leighton What is ultrasound Institute of Sound and Vibration Research Southampton University Highfield Southamp ion 6 lonel Rosenthal b Joe Z Sostaric Peter Riesz Sonodynamic therapy a review of the synergistic effects of drugs and ultrasound f Konstantinos N Malizos Michael E Hantes Vassilios Protopappas Athanasios Papachristos Low intensity pulsed ultrasound for bone healing An overview Department of Orthopaedic Surgery amp Musculoskeletal Trauma University Hospital of Larissa School of Heath Sciences University of Thessalia
11. Larissa Greece 8 Shiang Hu Ang Shu Woan Lee Kai Yet Lam Ultrasound guided reduction of distal radius fractures 9 Farzaneh Ahmadi lan V McLoughlin Sunita Chauhan Gail ter Haar Bio effects and safety of low intensity low frequency ultrasonic exposure 10 Healt Protection Agency Health Effect of Exposure to Ultrasound and Infrasound Report of the Indipendent advisory Group on Non lonising Radiation 17 Electromagnetic INTRODUCTION Electromagnetic Diatnermy is a non invasive treatment that uses an electric field able to produce an increase of temperature in the tissues through conversion of a source of electromagnetic energy into heat Heat generated is responsible for a number of biological actions that result in therapeutic effects well determined such as metabolism activation Initial vasoconstriction and vasodilation constant oweating thermal effect Muscle relaxation Modification of physical properties of fibrotic tissue Increase of cardiac activity and pulmonary hyper ventilation Increased consumption of O2 and CO2 elimination Electromagnetic diathermy is used clinically in three forms Analgesic action and sedative algo Relaxant action Stimulating action of tissue metabolism Vasomotor action MECHANISM OF ACTION Diathermy is a form of physical therapy instrumental that reactivates normal physiological processes of tissue metabolism transferring
12. below according to maximum output power of communications equipment oeparation distance according to frequency of transmitter Hated maximum output power of m transmitter W from 150 kHz to 80 MHz from 80 MHz to 800 MHz from 800 MHz to 2 5 GHz d 1 16 VP d 1 16 VP d 2 33 NP GRO Ol Cal A O 1 i505 Ose OS 1 FEL 2 10 6 06 009 Aro 100 Te yee OHCs Specified transmitters for a maximum output power not listed above recommended separation distance d in meters m can be estimated using equation applicable to frequenoy of transmitter where P is maximum rated power output transmitter in watts VV according to manufacturer of transmitter NOTE 1 At 80 MHz and 800 MHz applies separation distance for higher frequency range NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 66 APPENDIX C Warranty Certificate Under this warranty A W B s r l site in Repubblic of San Marino Strada del Lavoro 33 9 Z Gualdicciolo 4 892 Acquaviva warrants this product against compliance defects for duration of YEARS 2 two from date of delivery of product If during this period of guarantee product proves compliance defective AWB srl or authorized dealers will provide to repair or at discretion of AWB srl replace product or its defective parts upon in terms and conditions set forth below without charge for cost of labor and ma
13. energy to the biological field oy applying physi cal principle of the capacitor resulting in a technology that transfers energy biocompatible and allows to stress the tissues from the Inside therefore without unnecessary dissipation of energy Increase homogeneous in depth of the temperature generated by electrode does not cau se overheating of the skin structures and tissues are processed through a complete set of electrodes of different sizes allowing to apply therapy in depth and effectively on any struc ture osteo my articular of the human body Displacement currents produce three types of effects 18 Biochemist which balances the enzymatic disorder of fat metabolism and acce lerates ultra structural cell drawing oxygen rich blood speeding up and facilitating flow of lymphatic drainage of the peripheral areas not affected by cellulite Inermal for Joule effect produced by displacement currents induces a deep endothermic heating and homogeneously distributed Mechanical increasing velocity of fluid flow dralns hemo lymphatic stasis and tones vascular walls All three of these effects reinforce each other action of diathermy therapy then involves all the tissues even In deep way and homogeneous Deep action energy associated with diathermic field bear no dissipation in transfer to the tissue concering by treatment Homogeneous action increase temperature is generated by displacement currents whose intensi
14. press button Clear settin oelect Pathology desired through buttons lt lt PATHOLOGY gt sli Then confirm pathology through button lt PATHOLOGY gt gt oet up of device is now ready Press METTE to begin treatment Sutton M Sutton ness Button Button Button come back one step clear partial time Decrease power of transducer Increase power of transducer suspend treatment Here below lists of default values used by device for various pathology Treatment Port lymphedema time min KHz x x FAMILY PATHOLOGY Treatment Port Modul Duty P Duty M lymphedema time min KHz Hz ipomas 20 38 10 60 90 Cellulite Fibrous 30 38 60 90 Attention At the end of each treatment clean transducers before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual PHYSIOESTHETICS FUNCTION H D C From main menu press button Then press button H D C Clear setting Set up of device is now ready to begin treatment i fo 47C X 6596 000 l 0000 T 0000 Sutton M come back one step Button YF Decrease temperature of transducer Button y Y Increase temperatu
15. use Remove residual cream REFERENCE 1 Dr Neil Cherry A New Paradigm the physical biological and health effects of Radiofrequency Microwave Radiation Human Sciences Department P O Box 84 Lincoln University Canterbury New Zealand 2 Sridhar Pattanaik Biological effects of RF MW radiations on human Department of Electronics Berhampur University Berhampur India 3 Ali Zamanian and Oy Hardiman Electromagnetic Radiation and Human Health A Review of Sources and Effects Fluor Corporation Industrial and Infrastructure Group 4 Health Canada Limits of Human Exposure to Radiofrequency Electromagnetic Energy in the Frequency Range from 3 kHz to 300 GHz Safety Code 6 2009 5 Kwan Hoong Ng Non lonizing Radiations Sources Biological Effects Emissions and Exposures Department of Radiology Univer sity of Malaya Kuala Lumpur Malaysia 6 Robert F Cleveland Jr Jerry L Ulcek Questions and Answers about Biological Effects and Potential Hazards of Radiofrequency Elec tromagnetic Fields OET BULLETIN 56 Fourth Edition August 1999 f Sir William Stewart Chairman Power Density Radio frequency Non lonizing Radiation A report from the Independent Expert Group on Mobile Phones The Stewart Report 2000 8 Paolo Vecchia R diger Matthes Gunde Ziegelberger James Lin Richard Saunders Anthony Swerdlow Review of the scientific evi dence on dosimetry biological effects epidemiological observations and heal
16. 2 1 25mm Resistivo HM A2 005 1 100mm Resistivo HM A4 001 1 2x3mm Sferico SS A4 002 1 2 15 0 A4 003 1 Supporto Roller A A4 005 1 Roller Medium BASIC DIAT BASIC DIAT A2 006 1 25mm Resistivo Ring A4 004 1 Roller Light amp vo BASIC DIAT BASIC IAT A2 007 1 50mm Resistivo Ring A2 008 1 25mm Tripolare Ring OPTIONAL A2 009 1 50mm Tripolare Ring A1 001 1 50mm US Radial OPTIONAL OPTIONAL A1 002 1 50mm US Focused AA 008 1 Carrello Attrezzato A1 004 1 15mm US Sphere SETIONA Precautions for use Before to proceede to use device please read this manual and follow warnings and precau Device must be used only in rooms with electrical equipment designed and manufactured in compliance with applicable laws and regulations in particular it must be provided to ground Use of the device must be in full compliance with safety reguirements and regulations of the country you use both in respect of the operator and end user in particular in relation to the use of ultrasound and radiofrequency generators Use only the accessories listed in this manual which are designed and sized according to ins eecinealidevice Follow the instructions of this manual on way to apply the same accessories Keep the device always clean and well ordered Use device only in accordance with it
17. 81 7550 www a circle it e mail info a circle it cal IGE 1936 Rev 0 07 20140203 E nt 4 5 9 Mc e 8 p L 0 PER cities id ha nidi be um dd 7 Digs P d m mo x 0 1 E n F 0 M a BU S BEG SML EM CE TIS 7 2 o 1 N IG SET JH M yi NS Ar x n 1 A af oe
18. 96 UT gt 95 hole UT for 5 s 3 A m Level test IEC 60601 6 kV from contact 8kVon 2 KV for power supply 1 KV for input output 1 kV between phases 2 kV phase to ground 596 UT gt 95 hole in UT for 0 5 cycles 40 UT 60 hole in UT for 5 cycles 70 UT 30 hole in UT for 25 cycles 596 UT gt 95 hole UT for 5 s 3 Alm Immunity test Discharge Electrostatic ESD IEC 61000 4 2 Transient speed pulse sequences IEC 61000 4 4 Overvoltage IEC 61000 4 5 Voltage drop short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Magnetic field to line frequency 50 60Hz IEC 61000 4 8 Guide and declaration of manufacturer electromagnetic immunity Hecommended separation distance 3 V eff Conducted RF IEC 61000 4 6 from 150 kHz to 80 MHz outside ISM bands a 3 V eff d 21 16 VP d 1 16 V P from 80 MHz to 800 MHz d 2 33 V P from 800 MHz to 2 5 GHz Where P is maximum rated power output of transmitter in watts W according to the transmitter manufacturer and d is recommended separation distance in meters m Field pr cai pl ROTA MIA 2 5 GHz 3 V m strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than compliance level for each frequency interval b Interference may occur in vicinity of equipment marked with following symbol qx NOTE 1 UT is AC mains voltage prior to ap
19. Lavoro 33 9 Gualdicciolo 4 891 Acquaviva Rep San Marino Telex Ge EKT RONS 704 e mail ccare awb engineering com a circle s p a Via Ferrara 21 40018 San Pietro in Casale BO Italy Tel 89 0516817962 Fax 39 051 811349 e mail assistenza a circle it 72 73 SOLUTION Press urn off device Check Accessory urn on device If problem persists contact your authorized service rice XI Ip urn off device Check Accessory urn on device If problem persists contact your authorized service Press CONFIRM Jurn off device Check air intake device Wait 15 minutes Jurn on device If problem persists contact your authorized service Frese failed vo urn off device Check Accessory urn on device If problem persists contact your authorized service Press urn off device Check Accessory urn on device If problem persists contact your authorized service DESCRIPTION Accessories not provided Accessories not regularly matched Device Temperature too high Heading ACCessory Accessory not initialized APPENDIX G Device Error Messages CODE 2006 2007 2008 2009 2010 74 Press CONFIRM Turn off device Jurn on device If problem persists contact your authorized service Press CONFIRM Contact your authorized service SOLUTION Press CONFI
20. RM Tum off device urn on device If problem persists contact your authorized service Press CONFIRM Contact your authorized service Press CONFIRM lum off device um on device If problem persists contact your authorized service Press CONFIRM lum off device um on device If problem persists contact your autnorized service Press CONFIRM Jurn off device Check Accessory um on device If problem persists contact your authorized Service CODE 5003 Unknown error 8004 Request Scheduled Service CODE DESCRIPTION 100 Communication error between modules IO Notice 50 hours left for scheduled Maintenance of device 1005 Operation not Permitted Time Out Communications 1007 Accessories not found 2000 aa n E nt 4 5 9 Mc e 8 p L 0 PER cities id ha nidi be um dd 7 Digs P d m mo x 0 1 E n F 0 M a BU S BEG SML EM CE TIS 7 2 o 1 N IG SET JH M yi NS Ar x n 1 A af oe E nt 4 5 9 Mc e 8 p L 0 PER cities id ha nidi be um dd 7 Digs P d m mo x 0 1 E n F 0 M a BU S BEG SML EM CE TIS 7 2 o 1 N IG SET JH M yi NS Ar x n 1 A af oe Distributed by a circle s p a Via Ferrara 21 40018 San Pietro in Casale BO Tel 39 051
21. TION MANUAL This manual must be considered an integral part of the machine so it have to follow all its operational life You should give this manual also to new owner when you will sell device Keep this manual in a place protected from agents that can cause unnecessary damage and easily reached by operator It is important to read this manual very carefully before using device and whenever you have doubts regaraing the functioning Particular attention should be paid to safety precautions as may otherwise result in accidents narmtul to both people and for the device itself You can also find useful information which will facilitate use and maintenance he list of spare parts is not part of the manual because is deposited only at authorized dealers If the manual will be lost a ask directly to the manufacturer a duplicate It is recommended keep the manual near device and always accessible to the user in suitable place and do not to compromise the integrity of it 2 Device is provided with all the eguipment below so once you open the packaging check that the basic model is complete If any item is missing immediately contact your agent and or distribu tor Package content M2 010 1 DYNAMIX AA 001 1 SUPPORTO ELETTRODI X2 600 1 CAVO DI RETE C1 001 1 NEUTRAL GEL C1 002 1 NEUTRAL CREAM A2 015 1 STICK TIPO B A2 001 1 STICK TIPO A MN CN CELL NC NM n A1 020 1 15mm US Sphere A2 00
22. This method has been used for years and proposals that are in the market ranging from simple moisturizers creams medicament gels oharmaocological plaster It is a solution for many forms of blemishes diseases inflammatory painful etc To achieve desired results applications must be repeated and amount of active ingredient used is Proportional to the time of use of substance It is a way to nourish the cells of substances its needs and is a valuable and indispensable route of administration Technique of transdermal vehiculation adopted consists in micropertorations multiple of the skin with a roller equipped with needles Neealing is a technique antiaging micro inva sive Quick virtually painless with a very short recovery time and long lasting is one of the methods of revitalization or biostimulation skin and is in effect a micro perforation of the skin of the face or of various body regions performed with a particular roller whose pur pose to stimulate in a natural way the production of elastic and collagen fibers essential elements in give and maintain tone and support to the skin In the United States it is called Collagen Induction Therapy This technigue activates a number of repairing mechanisms that lead to the production of different growth factors cellular and tissue with consequent production of natural collagen MECHANISM OF ACTION Transdermal vehiculation acts on the skin causing a tra
23. ampering Damage resulting from Misuse included but not limited to a Use of product for other purposes than those provided or failure to follow instructions AWB srl on correct use and maintenance of product b Installation and use of product not comply with technical standards and safety regulations in the country which it is used c improper or incorrect installation of the software Repairs by unauthorized personnel or by customer himself Defects of plant or equipment which product has been connected Replacements and or repairs under warranty which cause immobilization of instrument do not have in any case effect of prolonging duration of warranty Will not be granted any compensation for lack of enjoyment Costs of travel and possible transport of equipment and spare parts to and from laboratories of the service are exclu ded from this guarantee Replaced parts become property of manufacturer Buyer is obliged to give A W B s r l 15 working days and means necessary to proceed with necessary repairs and deliveries of spare parts replaced Otherwise it will be exempted from guarantee Restriction and Limitation of Liability Failure to follow terms and conditions of guarantee during and at expiration of warranty it can be cause of exemption from liability of manufacturer in case of damage due to products delivered Manufacturer is not liable for any property damage or bodily accident which occurred after an installation does
24. an Marino 01 November 2013 Tiziano Pratellesi Serial Number 63 Guide and declaration of manufacturer electromagnetic emissions Dynamix is intended for use in electromagnetic environment specified below Customer or user of Model Dynamix should assure that it is used in this kind of environment Emissions Test Conformity Electromagnetic environment guide Model Dynamix emits RF electromagnetic energy to perform its RF emissions CISPR 11 GROUP 2 expected functions electronic equipment placed nearby may be affected RF emissions CISPR 11 CLASS B Model Dynamix is suitable for use in all buildings including those intended for domestic use and those directly connected to public Harmonic emissions low voltage power supply which supplies buildings used for IEC 61000 3 2 NOT APPLICABLE domestic purposes Warning This device is intended for use only by professional health Emissions of voltage fluctuations personnel This device can cause radio interference or may disrupt flicker NOT APPLICABLE operation of equipment located nearby It may be necessary to take IEC 61000 3 3 measures to mitigate these disorders such as re orientation and re positioning of Dynamix or shielding of room ESD precautionary procedures Connectors identified with ESD warning symbol should not be touched with fingers or hand held TOOLS without before take appropriate precautionary procedures Precautionary procedures include meth
25. before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual MANUAL NEUROKINESI THERAPY N M F From main menu press button Then press button Sutton M come back one step Set data with buttons em and Button come back one 0 clear setting Button go forward one step Set data with buttons a and Then confirm selection with Button come back one step Clear selection Press buttons em 0 to change time Press METTE to begin treatment Button M come back one step Clear setting Button NP Button y Y Increase power of transducer Sutton ZIA suspend treatment Decrease power of transducer Here below lists of default values used by device for various pathology 51 Attention At the end of each treatment clean transducers before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual 52 PHYSIOESTHETICS FUNCTION H I C U Duty P 76 o0 50 50 Modul Hz From main menu press button Then
26. ct desired frequency sweep Button come back one step MAIN MENU Cancel Setting EEL EG OULIONS Ew or O OE tiie c Smarr to begin treatment o EM MAIN MENU Cancel Setting come back one step Button Decrease power of transducer Button y Y Increase power of transducer suo PAUSE suspend treatment Here below lists of default values used by device for various pathology 43 PATHOLOGY Treatment Time min Frequency Sweep Acute Pain 20 5 8 360 480 Phase prostaglandin 20 5 8 360 480 Rehabilitation Post Traumatic 20 30 120 240 360 Hehabilitation Post Surgery 20 30 120 240 360 Attention At the end of each treatment clean transducers before putting into compartment S a 7 0 3 P Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual NEUROKINESI HERAPY N M F SUPERFICIAL A C T From main menu press button Then press button Button RR MAIN MENU Cancel Setting come back one step Press button A C T Sutton lt lt MAIN MENU Cancel Setting come back one step Select desired frequency sweep sion MAIN MENU cancel Setting come back one step Press buttons lt or 016 exte Pross 7 to begin treatme
27. d to objectively identity those areas as well as to identify various trigger points comparing to surrounding areas These areas are expression of diseases or dysfunctions of the underlying tissues or anatomically related to these areas of the skin and are related to alterations in neurological intormation and autonomic correspondent Hesults also show that electromedical commercial products can be helpful in locating these areas altered electro physiologically Microcurrent have aim to restore normal electroonysiological valence of these areas of the skin by introducing a corrective input to the somatic dysfunction related INDICATIONS OF USE Clinical indications of Microcurrents mainly concern the utility in treatment of neuropathic pain disorders Recognized therapeutic effects are Localized analgesia Release of endoronins and neuro peptides regulators Localized hyperemia 21 Elective indications for this technique are Post surgical rehabilitation Post traumatic renabilitation syndromes pain osteo myo articular Chronic pains Neuropathic pain Acute post operating pain Peripheral sensory polyneuropathy Trigeminal neuralgia Neurological outcome of herniated nucleus pulposus Cervical spondylosis Outcomes from painful spinal canal narrow congenital acquired Plexus disorders acquired and iatrogenic Neuritis Thoracic outlet compression syndrome Thoracic Outlet syndrome Outc
28. e Manufacturer Attention Device is not protected against penetration of liquids Attention Any manipulation substitution INTERVENTION on the device not performed by AUTHORIZED PERSONNEL voids the warranty and non liability of the manufacturer for damage to persons or property which may result D So _ SS ont aes 4 Attention Installation must be performed by a qualified technician A Ie e 8 1479 8T SEQUENCE OF INSTALLATION Before installing device check package content following the instructions described in chapter 2 package content Before installing device make sure that the electrical system is standard according to the laws of the country Place device on a horizontal shelf suitable for its weight away from danger for the operator and the patient doors heat etc Be careful not to block air vents positioned under device Use extreme caution when hanale device in order to avoid damage or Injury Device must not be put into operation in case of fault on the control panel and if you find any damaged parts CONNECTION POWER CABLE AND ACCESSORIES Before to proceed of connection power cable make sure that general switch Is set to O Insert power cable as supplied with the device Attention inse Do not connect device to multiple plug if is not standard ROG pur a a T a rd cam m E 12
29. ep Sutton MAIN MENU oet up of device is now ready Tess to begin treatment 3utton lt lt come back one step MAIN MENU Cancel Setting Butto N Decreases power to transducer Button y Y Increase power to transducer Suspend treatment Attention At the end of each treatment clean transducers before putting into compartment i ee PA he E Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual a _ 38 PHYSIOTHERAPY FUNCTION C A D HYPERTHERMIA At the end of each treatment clean transducers before putting into compartment From main menu press button EL MEM Then press button CAD MAIN MENU Cancel Setting ress button E Button MAIN MENU Cancel Setting come back one step oet up of device is now ready Press METTE to begin treatment come back one step MAIN MENU Button Np Decrease power to transducer Button y Y Increase power to transducer suspend treatment Attention cH Aw I SO AE PA EXTA Satu Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual T ks 7 RIPA T Si no RUE SE e a la 39 PHYSIOTHERAPY FUNCTION C A D
30. er of transducer suspend treatment 47 PATHOLOGY Treatment time min Frequency Sweep Acute Pain O 30 960 30 480 Chronic Pain Tis Se Su 20 Attention At the end of each treatment clean transducers before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual NEUROKINESI THERAPY N M F DEEP From main menu press button Then press button oo lt lt MAIN MENU Clear setting come back one step Select desired frequency sweep oo lt lt MAIN MENU Olear setting come back one step to change time Press buttons ien 0 o EE MAIN MENU Clear setting to begin treatment come back one step Sutton Decrease power of transducer Button 7 NX increase power of transducer Button TM suspend treatment Here below lists of default values used by device for various pathology 49 PATHOLOGY Treatment time min Frequency Sweep 20 3 8 15 60 P 15 60 20 3 8 15 60 20 Hose Zo 30 90 60 100 DO 30 90 60 100 Attention Chronic pains Algodystrophies Complex regional pain syndrome Carpal Tunnel Acute neuralgia Ernie At the end of each treatment clean transducers
31. esitherapy Physicesthetics Rehabilitation Here below are lists of programs on the device PHYSIOTHERAPY AND SPORTS MEDICINE section Mechanics Diathermy DACU Arthropathy Arthritis Arthrosis Adhesive Capsulitis Calcifications Muscular Tendon Osteophytosis Myofascial pains Iendinopathies Bursitis Fasciitis 5 lendinosis Muscle sprain Elongations Contractures Fibrosis Tendon sprain Ligament sprain Ematomatose sprain OXICOSIS Acidosa Edematomatosa Section Electromagnetic Diathermy CAD Function FRAXEL low back pain lumbar 2 Myofascial pains 02 Function HYPER I HERMIA Muscle Sprain Muscle fibrosis Preparation for other treatments Section transdermal vehiculation MTD Conveying of active ingredients Scars Acne Scars Reduction of Inflammatory states Treatment of Pain NEUROKINESITHERAPY Section Neuro Frequency Modulation Superficial Function FAT Acute Pain Phase prostaglandin Rehabilitation Post Iraumatic Rehabilitation Post Surgical Function ACT Chronic Pain Ischemic phase acidotic RUN e A Acute Pain Chronic Pain Section Neuro Frequency Modulation Deep Neurogenic pain Chronic Pain Dystrophy Pain Complex regional pain syndrome Carpal Tunnel Acute neuralgia Hernia 28 PHYSIOESTHETICS REHABILITATION Section Diathermy Mechanics HICU Function Lymphoedema Lymphat
32. faction is transformed into heat through mechanical friction between the molecu les Thermal effects of ultrasound can cause Higher extensibility of collagen Increase speed of nerve conduction Alteration of local vascular perfusion Increased enzyme activity Increase contractile activity of skeletal muscle Increase of nociceptive threshold Therapeutic Ultrasounds are used clinically in three forms Continuous for increasing temperature of deep tissues Pulsed for activation of physiological effects non thermal As factor vehicle phonophoresis for transdermal vehiculation of topical medications MECHANISM OF ACTION Ultrasounds are non ionizing radiation of mechanical nature unlike radio frequency and microwave with which they identity specific regions of the electromagnetic spectrumic 14 are a form of mechanical energy and therefore to be able to propagate needs an elastic means such as plasma or liquid Humphrey 2007 They extends from frequencies above 20 kHz upper limit of audibility for human ear up to frequencies of a few hundred MHz and around 1 GHz leave place to so called hyperso 1 Ultrasounds pass through tissues determine effects traditionally separated into thermal and non thermal Miller 1996 non thermal regard mainly cavitation Thermal effects typi cally occur for exposures in continuous wave while non thermal effects for exposures in pulsed wave Milowska 2007 T
33. hese two effects are not really separable namely can not assume presence of a single type of effects except in case of lithotripsy which effect induced is mechanical For all other situations it is wise to assume that non thermal effects are always accompanied by evolution of heat Baker 2001 INDICATION OF USE Clinical indications of mechanical diathermy mainly concern usefulness of heating deep tissue Heating of collagen increases its extensibility altering tertiary molecular bond Hecognized therapeutic effects are Analgesic due to action of heat and also to a direct action of ultrasound on sensitive nerve endings Action fibrolitic oscillations particles of tissues produced by ultrasound determine disruption of the collagen fibers of fibrous tissues Irophic effects vasodilation which follows elevation of temperature facilitates removal of catabolites and make reach substances nutrients and oxygen to the tissues thereby ultrasound improves tissue tropism facilitate repairing of damage tissue and accelerate resolution of inflammatory processes 3 Mechanics appears to be useful aid for sectors Aesthetic Medical Dermatology Phlebological Physiotherapy oports Medicine 15 CONTRAINDICATIONS Ultrasound must not be used on Cardiac area On cephalic region and specialized tissues metaphysis fertile testis ovary opecial precautions are necessary in the following conditions
34. ic stasis Stimulation of Basal Metabolism Edematous cellulitis Function Lipoedemi Lipomas Cellulite Fibrous Section Electromagnetic Diathermy HDC Stimulation of microcirculation Stimulation of fibrotic tissue Metabolism Activation Section transdermal vehiculation MTD Blostimulation Tissue 595 otretch Marks Stimulation of microcirculation Note For use refer to Chapter 6 Using the Device Therapeutic E pr can be in ine CD EE to e User AVRAI M n gt d s frese SE 29 Use of device 30 SWITCHING ON AND SWITCHING OFF Move the switch placed on the back of device in position 1 Device performs an initial test IN the event that test detects an erroron the screen will be visualized indicating error code 2016 For a full list errors see Appendix G After initial test If anomalies are not found on the screen will be visualized that device is ready for use For correct use of device refer to following chapters Always switch off device when software Is on this screen Attention Pay particular attention to error messages displayed by device AME CE GG _ DIRTI IAT COLT TE MI pei MEN 31 PHYSIOTHERAPY FUNCTION D A C U AUTOMATIC From main screen press button F T R Press button Eus Press button outton lt lt come back one step Cancel Setting Select Pathology des
35. ired through buttons ff lt PATHOLOGY gt ei Then confirm pathology through button dies lt PATHOLOGY gt oelect the Under Pathology through the buttons RB gt Then confirm the Under Pathology through button em UNDER PATHOLOGY gt gt Device setting is now ready Pross START to begin treatment Press come back one step Cancel Setting 32 Treatment time min 10 10 10 10 IO 10 10 10 10 9 10 10 10 10 10 10 10 10 10 MODE clear partial time Button Button lim Button D Increases power to transducer Decreases power to transducer suspend treatment Here below are listed possible selections provided by device FAMILY PATHOLOGY Superficial Arthritis Arthropathy ERE ouperficial 085 Adhesive Capsulitis Mo MTM E S Muscle ium MD Calcifications nou Tendon MISSE Myofascial pain IRENE QUO RUE a Tendinitis Superficial Tendinosis E A lendinopathies nuo Fasciitis WE S LT Bursitis taper aie Treatment time min 10 I TE Ke 10 10 10 10 10 10 10 9 10 10 10 MODE ouperticial Deep Superficial Deep Superficial Deep Superficial Deep Superficial Deep Superficial Deep Superficial Deep FAMILY PATHOLOGY Elongations Distraction Muscle Contractures Fibrosis Tendon Distractions Ligamentous Ematomatose Acidosis
36. ise Curtis MSc NMT Stephen Fallows PhD a Michael Morris MSc Carolyn McMakin MA DC The efficacy of frequency speci fic microcurrent therapy on delayed onset muscle soreness 4 Carolyn R McMakin M A D C Microcurrent therpy a novel treatment method for chronic low back myofascial pain D Joseph M Mercola and Daniel L Kirsch 1995 coined the term microcurrent electrical therapy MET to define a new form of electo medical intervention using biocompatible waveforms An Introduction to Microcurrent Electrical Therapy 6 CAROLYN MOMAKIN MA DC Nonpharmacologic Treatment of Neuropathic Pain Using Frequency Specific Microcurrent f Amal Anmed Sherein S A Elgayed Ibrahim M Ibrahim Polarity effect of microcurrent electrical stimulation on tendon healing Bio mechanical and histopathological studies 6 David G Young N D Frequency Specific Microcurrent Certified Microcurrent Specialist 9 Souza A R Cardoso M E O Braga G Albuquerque A C Almeida S T P Ferreira M J C Femandes G L T Camacho A C L F Lima R C Almeida A C C Mattos D M M Duarte R M Nascimento S F 8 Framil R A Borba H R Dir G F Evaluation Of The Effects Microcurrent In Saccharomyces Cerevisiae As An Experimental Biological Model 23 Transdermal vehiculation INTRODUCTION Transdermal vehiculation is a non invasive treatment which provides absorption of active ingredients through the skin
37. isplay Type Resolution X Y L CD 640x480 User Interface Resolution Touch Screen oO0DPI Low Frequency Section Diathermy Mechanics Maximum Power Transducer Watt cm2 2 Resonance Frequency KHz rom GUNO Continuous Pulsed ACP 60 OUS from 1 to 500 Pulsed okin Touch 19 61 Type of Emission Control Output Signal Maximum Treatment Time Low Frequency Section Microcurrents Maximum Output Current Electrode Work Frequency Type of Emission Control Output Signal Maximum Treatment Time Section Medium Frequency Electromagnetic diathermy s Section Medium Frequency transdermal vehiculation x NOIE See attached CD for more information of device 62 1936 APPENDIX B Declaration of Conformity MANUFACTURER AWB S r l Strada del Lavoro 9 LEGAL REPRESENTATIVE FOR EUROPE Pratellesi Tiziano 4 892 Acquaviva Rep San Marino RSM Viale Tiberio n 11 47921 Rimini RN PIVA 04026810400 Cod Fiscale 91136650404 This declaration of conformity is issued under sole responsibility of the manufacturer Product Type Multi frequency generator Code M2 010 1 CLASSIFICATION MDD Class II A in accordance with Annex IX of Directive 93 42 EC INTENDED USE Medical device for therapeutic use and outpatient Object of declaration described above is in conformity with following laws EU DIRECTIVES DECISION No 768 2008 EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008
38. le for waste disposal General Index E nt 4 5 9 Mc e 8 p L 0 PER cities id ha nidi be um dd 7 Digs P d m mo x 0 1 E n F 0 M a BU S BEG SML EM CE TIS 7 2 o 1 N IG SET JH M yi NS Ar x n 1 A af oe Introduction INTRODUCTION Dynamix exploit use of the physics of electrical signals for therapeutic purposes Designed and developed by treatments in the fields of Aesthetic Medicine and Dermatology Vascular Medicine Physiotherapy Rehabilitation oports Medicine Use of smart accessories that make up the device allows to reduce risks arising from improper use of the device The non invasive method expand greatly the target of people that can be offered Application protocols are performed through use of standard technologies and already described in the literature such as Diathermy Mechanics obtained through use of a generator regulator voltage and specific ultrasound applicators Electromagnetic diathermy obtained through use of HF generator and type of specific applicators resistive and capacitive Microcurrents obtained through use of a generator voltage costant current and specific applicators of type resistive Transdermal transmissive obtained through use of a function generator that uses the technique of eporazione transdermal and specific applicators and active principles AIM OF INSTRUC
39. not comply with legal or regulatory provisions of coun try which it occurs appliance installation following an intervention not provided by user manual of manufacturer and or carried by user or by a third party not appro ved by manufacturer Warranty is also excluded in following cases Damage occurring during transport This unit travels to risk and danger of recipient It is latter addressee before proceeding to shipment make sure it is in perfect condition Lack of maintenance prescribed in manual of the manufacturer Incorrect installation faulty electrical connections or no connection to ground a different voltage than that indicated on rating plate 67 APPENDIX D Data Plate DISPOSITIVO POOL Ornate CODI Pm O10 das Mi CE K ICE Output Diathermy Mechanics and Output Electromagnetic Diathermy and Transdermal Vehiculation Auxiliary Output and Expansion Data Reserved use only for Technical Assistance Service 68 Device Packing e 5 Ww ch Xx gt d O lt lt p gt 1 DESCRIPTION CE MARKING ACCREDITATION NUMBER OF MEDICAL DEVICE FOLLOW INSTRUCTIONS FOR USE MANUFACTURER PROTECTION DEGREE IP ESD WARNING SIGNAL RADIATION NON IONIZING EXPANSION DATA TYPE B APPLIED PART 69 REF 1936 IP20 dts 4 DATA I O REF DESCRIPTION PROTECT AGAINST SUNLIGHT
40. nsient increase in permeability of the tissue Active ingredients conveyed come directly to cellular receptors in dosage prearranged and so therapeutically more effective Therapeutic effect is direct without mediation of the bloodstream This occurs when in a cell using an electric pulse is generated a potential trans memora ne double lipid layer of the cell is subjected to a temporary readjustment with formation of agueous channels in cell membrane said electropores These electropores determine passage of molecules that otherwise would not pass ever the stratum comeum With transdermal vehiculation can convey a large quantity of substances both low and high molecular weight such as 24 Vitamin C Glycosaminoglycans Camitine Hyaluronic Acid MICI INDICATION OF USE Clinical indications of transdermal vehiculation mainly concern possibility of drugs and active ingredients also with large molecular weight that you do not convey by mere friction of the product There are no recognized therapeutic effects to method than those given by powers of the substance carried Elective indications for this technique are Acne Acne scars Stretch marks Reduction of localized inflammatory status Pain treatment CONTRAINDICATIONS Do not use transdermal vehiculation on Specialized tissues Metaphysis fertile testis ovary Special precautions are necessary under following conditions When you make
41. nt Sutton RE MAIN MENU Cancel Setting come back one step Sutton NYY Decrease power of transducer Button Ah Increase power of transducer oo suspend treatment Here below lists of default values used by device for various patnology PATHOLOGY Treatment Time min Frequency Sweep Ghronic Pain 20 5 8 15 60 30 120 Ischemic acidosis 20 5 8 15 60 60 180 Attention At the end of each treatment clean transducers before putting into compartment Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual 46 NEUROKINESI I HERAPY N M F SUPERFICIAL P C T 8 2 SS mmu 1 Here below lists of default values used by device for various pathology From main menu press button Then press button uon gt gt come back one step MAIN MENU Clear setting Press button P C T Button EN come back one 0 MAIN MENU Olear setting Select desired frequency sweep Sutton EN come back one 0 MAIN MENU Clear setting feos IMO Eu I gt to change time uon AN come back one step MAIN MENU Clear setting to begin treatment Button Np Decrease power of transducer Button y Y increase pow
42. ods that prevent formation of electrostatic charges see Guide and declaration of manufacturer electromagnetic immunity Static electricity discharge of a body through casing of device or to ground or to large metal ob ject Connect themselves by special clamp and cable to device or to ground 64 Guide and declaration of manufacturer electromagnetic immunity Dynamix is intended for use in electromagnetic environment specified below Customer or user of Model Dynamix should assure that it is used in kind of environment Electromagnetic environment guide Floors should be wood concrete or ceramic If floors are covered with synthetic material relative humidity should be at least 30 Quality of network supply voltage should be of typical commercial or hospital environment Magnetic fields at network frequency should have characteristic levels of typical commercial or hospital environment HF communications equipment portable and mobile should not be used closer to any part of Dynamix including cables except when they respect recommended separation distance calculated from equation applicable to frequency of transmitter 65 Conformity level 6 kV from contact 8 kV on air 2 kV for power supply 1 kV for input output 1 kV between phases 2 kV phase to ground 596 UT gt 95 hole in UT for 0 5 cycles 40 UT 60 hole in UT for 5 cycles 70 UT 30 hole in UT for 25 cycles 5
43. omes nerve centers of Neurofibromatosis Complex Regional Pain Syndrome CONTRAINDICATIONS Microcurrents are not intended for use on Mucous membranes Open wounds 50165 Skin and fungal infections opecial attention should be taken In presence of skin alterations In patients with altered skin sensation Microcurrents also must never be applied in presence of Pace maker Epilepsy 22 Neoplasms Microcurrents also must never be used on Pregnant women Patients who are clearly unable to communicate to the therapist any painful sensation SIANDARD METHODS OF TREATMENT Basic protocol for the treatment is substantially based on 5 steps Application of electrode on the skin after cleansing oet up appropriate amount of microcurrent Perform slow movements on the skin in search of areas with altered impedance Electrode placement on all treatment areas found Mobilisation of the segment only for dynamic treatments REFERENCE 1 Fatemeh Saniee 1 Hamid Reza Ghafarian Shirazi 2 3 Khosroo Khademi Kalantari4 Parviz Yazdanpanah5 Asghar Reza Soltani6 Na der Dabiri Nazanin Ghafarian Shirazi4 Farzad Karimpour1 Consider of Micro Current s effect to variation of Facial Wrinkle trend Rando mized Clinical Trial Study 2 Carolyn R McMakina Walter M Gregoryb Terry M Phillipsc Cytokine changes with microcurrent treatment of fibromyalgia associa ted with cervical spine trauma 9 Den
44. on a common framework for marketing of products and repealing Decision 93 465 EEC COUNCIL DIRECTIVE 93 42 EEC of 14 June 1993 concerning medical devices Edited by gt M1 Directive 98 79 EC of the European Parliament and of the Council of 27 October 1998 gt M2 Directive 2000 70 EC of the European Parliament and of the Council of 16 November 2000 P MG Directive 2001 1 04 EC of the European Parliament and of the Council of 7 December 2001 M4 Regulation EC No 1882 2008 of the European Parliament and of the Council of 29 September 2008 b M5 Directive 2007 47 EC of the European Parliament and of the Council of 5 September 2007 DIRECTIVE 201 1 65 EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of use of certain hazardous substances in electrical and electronic equipment 2012 19 UE DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 Waste Electrical and Electronic Equipment WEEE HARMONISED RULES IEC 60601 1 2007 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC 60601 1 2 2007 Medical electrical eguipment Part 1 General reguirements for safety Collateral standard Electromagnetic compatibility Reguirements and tests CERTIFICATION AUTHORITY TUV Rheinland Italy S r l Via Enrico Mattei 3 20010 Pogliano Milanese MI Milan ID 1936 ID CERTIFICATE 60090406 0001 HD PLACE AND DATE OF ISSUE SIGNATURE Rep S
45. plication of test level NOTE 2 At 80 MHz and 800 MHz applies separation distance for higher frequency range NOTE 3 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio equipment transmitters AM and FM radio broadcast and TV broadcast can not be predicted theoretically with accuracy For assess electromagnetic environment due to fixed HF transmitters you should consider an electromagnetic site survey If measured field strength in place where you use Dynamix exceeds level of compliance with applicable above should be placed under observation operation of Dynamix If abnormal performance is observed additional measures may be necessary such as reorienting or position of Dynamix b Field strength in freguenoy range from 150 kHz to 80 MHz should be less than 3 V m Recommended separation distances between portable and mobile communications equipment and Dynamix Dynamix is intended for use in an electromagnetic environment which RF radiated disturbances are under control Customer or user of Dynamix can Nelo to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile communication devices in RF communications equipment transmitters and Dynamix as recommended
46. re of transducer 2 T Sutton EM suspend treatment po EZ Secca Here below lists of default values used by device for various pathology Duty M PATHOLOGY Treatment time min Port KHz Modul Hz Duty P 96 4 0 Stimulation of microcirculation tS AQO 2 AQ 50 Stimulation of fibrotic tissue to 400 42 40 50 Activation of Metabolism ES AOQ 47 40 319 Attention At the end of each treatment clean transducers before putting into compartment TERT l ne an E 8 1 E 54 55 Note Treatment time indicated is indicative and dependent on treated surface Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual PHYSIOESTHETICS FUNCTION M T D 0000 mo 0000 J E0000 Z 0000 p _ Decrease power of transducer From main menu oress button Then press button M T D Olear setting MAIN MENU oet up of device is now ready c EM Sutton M Dutton Button lim Button ii Increase power of transducer to begin treatment come back one step clear setting clear partial time suspend treatment Here below lists of default values used by device for various pathology e Duty M 96 33 100 20 100 38 100 38 100 56 Modul Hz Treatment Port K
47. s 57 Attention At the end of each treatment clean transducers before putting into compartment Note More information on diseases treated Therapeutic cards etc are available on CD attached to this Manual Note Treatment time indicated is indicative and dependent on treated surface Cleaning 6 Casing of device and accessories can be cleaned with a damp cloth It is possible to use an anti Septic cleanser or a mild detergent Avoid using chemical cleaners rough cloth or harsh deter gents that may damage surfaces of casing and accessories Attention before cleaning or disinfecting unit disconnect equipment from power grid Keep equipment away from water TERM J 0 E Attention Device is not protected against penetration of liquids Avoid splashing or infiltration of liquids or any kind of diving Scheduled Maintenance System has been designed to operate reliably with minimal maintenance We recommend you to perform periodic maintenance by authorized personnel For this purpose here below a table of schedules maintenance to various parts of the system Note For scheduled maintenance contact service assistance Part of the system Type of Maintenance Cadence 500 hours and or 2 Ultrasound Accessories Visual inspection and functional years 1000 hours and or 2 Accessories HF Microcurrents Visual inspection and functional nd i 2000 hours and or
48. s applications on mucous membranes In presence of Varicose Veins Do not use transdermal vehiculation also in presence of Pace maker Epilepsy Neoplasms Do not use transdermal vehiculation on Pregnantwomen Patients who are clearly unable to communicate to the therapist any painful sensation 25 STANDARD METHODS OF TREATMENT Basic protocol for transdermal vehiculation is fundamentally based on 5 Steps Cleansing skin to remove makeup residue and smog Apply a lotion that can normalize pH skin Applying a gel containing all active ingredients that plastic dermatologist chooses to convey vitamins amino acids hyaluronic acid mesotherapy drugs IIDOlytic Massage gel of variable duration dependent on the area and by protocol of use Removing gel by cleansing and application of special creams REFERENCE 1 Marc B Brown Matthew J Traynor Gary P Martin and Franklin K Akomeah TRANSDERMAL DRUG DELIVERY SYSTEMS SKIN PERTURBATION DEVICES MedPharm Ltd Unit 3 Chancellor Court 50 Occam Road Surrey Research Park Guildford GU2 7YN UK 2 Heather A E Benson Transdermal Drug Delivery Penetration Enhancement Techniques Western Australian Biomedical Research Institute School of Pharmacy Curtin University of Technology GPO Box U1987 Perth Westem Australia 6845 3 K P SAMPATH KUMAR DEBJIT BHOWMIK AND CHIRANJIB B R M CHANDIRA Transdermal drug delivery system A novel drug deli very
49. s intended use Ihe manufacturer assumes no re sponsibility for damage to persons or property caused by incorrect use of device Place power cable in a way that can not be trampled Do not put any objects on the device and or power cable Avold exposure to excessive heat Do not use device in presence of mixture flammable atmospheres Do not use device in environments with high electromagnetic fields Do not use device in the same room at the same time with other devices that emit radio waves at high frequency shortwave microwave radio frequency depilator etc It may cause malfunctions in the use of device 10 Do not use on the customer other devices at the same time to this Do not use device in case casing nandpiece and cables are beginning to broke For disconnect power cable hanapieces or other accessories never pull on the cable itself Remember to turn off device at the end of each working day his device must be put into operation and used only by trained and instructed personnel on the techniques of treatment Contact your authorized service provider by the manufacturer in case of damage or deterioration of the accessories NOTE For treatment modality refers to the support attached GUIDELINES FOR TREATMENT Attention Use of device is only allowed to medical staff and or health care professional if ena bled through appropriate course carried out by personnel authorized by th
50. system and its market scope and opportunities Coimbatore medical college Karpagam University Coimbatore Tamilnadu India 4 Archana Gaikwad Transdermal drug delivery system Formulation aspects and evaluation Reviewed Article Accepted 7 February GAS D Latheeshjlal L P Phanitejaswini Y Soujanya U Swapna V Sarika G Moulika Transdermal Drug Delivery Systems An Overview De partment of Pharmacy Maheshwara Institute of Pharmacy Hyderabad India 6 Gajanan Darwhekar Dinesh Kumar Jain Vinod Kumar Patidar Formulation and Evaluation of Transdermal Drug Delivery System of Clopidogrel Bisulfate College of Pharmacy IPS academy Indore Rajendra Nagar A B Road Indore 452012 M P f 1Jain Amit K 2Sethi Mittul A SYSTEMATIC REVIEW ON TRANSDERMAL DRUG DELIVERY SYSTEM International Journal of Pharma ceutical Studies and Research 8 Ramteke K H 1 Dhole S N 1 Patil S V 2 TRANSDERMAL DRUG DELIVERY SYSTEM A REVIEW Journal of Advanced Scientific Re search 9 Leena Suntomsuk Capillary Electrophoresis in Pharmaceutical Analysis A Survey on Recent Applications Faculty of Pharmacy Mahi dol University 447 Sri Ayudhaya Rd Rajathevee Bangkok 10400 Thailand 10 Jeff Prischmann Diagnostic Lab Manager North Dakota State Seed Department Basics and Theory of Electrophoresis LIST OF TREATMENTS Programs are divided into three main sections Physiotherapy and Sports Medicine 26 27 Neurokin
51. terials Terms This warranty will be valid only if product with compliance defects will be presented together with invoice or other proof of purchase and warranty certificate to dealer who will be responsible to send product to an authorized service center AWB s r l together with a statement from reseller indicating date of delivery type of product and name A W B s r l reserve right to refuse work under warranty in absence of these documents or in case of information contained in it are incomplete or illegible This warranty does not cover any costs and or damages and or defects resulting from modifications or adjustments to product without prior written consent of AWB srl in order to conform to safety standards or national or local regulations in other countries than those for which product was originally designed and manufactured This warranty will be void if model or serial number marked on product has been altered deleted removed or made illegible Are excluded from warranty Periodic maintenance or replacement of parts subject to normal usury and wear and tear Any adjustments and or modifications made to product without prior written consent of manufacturer to change characteristics to those described in manual of use and maintenance Accessories however warranty is void in those cases where failure is caused by faulty power supply or connection use of non original accessories or damage caused by bumps drops and t
52. th consequences concerning exposure to high frequency electromagnetic fields 100 kHz to 300 GHz ICNIPR 16 2009 9 Lennart Hardell a Cindy Sage b Biological effects from electromagnetic field exposure and public exposure standards a Depart ment of Oncology University Hospital SE 701 85 O rebro Sweden b Sage Associates Santa Barbara CA USA 10 Kenneth R Foster Fellow IEEE Thermal and Nonthermal Mechanisms of Interaction of Radio Freguenoy Energy with Biological Sy Stems 20 Microcurrents INTRODUCTION Microcurrents have a wide range of applications in medical field tested by muscular rehabilitation macular degeneration and wound healing Use of microcurrent started in medical field in the United States in 1960 where they treated patients with post stroke and bells palsy System is based on the process of rehabilitation of myo filament stimulating them with small amounts of electricity reflects same natural body current and works in harmony with body s electrical system These pulses trigger a chemical reaction at cellular level by increasing effectiveness of the use of ATP adenosine triphosphate a protein which is defined as the energy of life MECHANISM OF ACTION Numerous clinical studies support the concept of changing skin impedance in certain epidermis areas corresponding to areas of active pain projected or developed in their surroundings It is shown that skin resistance Is an excellent metho
53. ty is directly related to the force of attraction and or repulsion exerted from active electrode which is constant because it is determined at the level of the power generator INDICATION FOR USE Main effects of biostimulation are Hyperemia tissue for expansion and activation of the capillary microcirculation Hyper tissue oxygenation with reduction of inflammatory processes Venous lymphatic drainage with reduction of edema and congestive stasis Femoval of catabolites tissue Pain Reduction for desensitization of peripheral terminations and increased endorphins Muscle relaxant action CONTRAINDICATIONS Electromagnetic diathermy must not be used oni Specialized tissues Metaphysis fertile testis ovary Special precautions are necessary under following conditions When making applications on mucous membranes IN presence of varicose veins Electromagnetic Diathermy also must never be applied in presence of Pace maker 19 Epilepsy Neoplasms Electromagnetic Diathermy also must never be used on Pregnant woman Patients who are clearly unable to communicate to the therapist any painful sensation STANDARD METHODS OF TREATMENT Basic protocol for Electromagnetic diathermy is essentially based on three steps Apply a scrolling cream on the part to be treated Put hanapiece on the area with slow and circular movements along muscle fibers Duration depends on the treated area and protocol in
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