RC ART DENAS MS Vertebra 2 Operation Manual

Device for dynamic electostimulation and electomassage

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LLC "RC ART" Ekaterinburg, Russia
Device for dynamic electostimulation
and electomassage
DENAS
Operation Manual
RC ART 13.0-03.72-02 РЭ
Россия/
Russia
ЕС, все
страны/
EU, all
США/
USA
Канада/
Canada
®
Vertebra 2

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Table of Contents
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Summary of Contents for RC ART DENAS MS Vertebra 2

  • Page 1 LLC "RC ART" Ekaterinburg, Russia Device for dynamic electostimulation and electomassage ® DENAS Vertebra 2 Operation Manual RC ART 13.0-03.72-02 РЭ Россия/ Russia ЕС, все страны/ EU, all США/ Канада/ Canada...
  • Page 2: Table Of Contents

    TAblE of coNTENTS 1. Safety measures................4 2. Purpose of the device..............8 3. General information on method, used in the device..9 4. Device description..............10 5. Indications and contraindications for use......12 6. Conditions and order of treatment........18 7. Technical maintenance and order of replacement of batteries............27 8.
  • Page 3 Thank you for purchasing device DENAS®-Vertebra-2. We hope that this device will help you to maintain your GOOD health in many years to come. In order to make use of the unit effective and safe, please, carefully read all sections of this manual.
  • Page 4: Safety Measures

    1. SAfETY MEASURES Pay attention to all information, marked with this sign. It is important for your safety and proper use of the device. Information, contained present operations manual, is important for your safety and proper use and maintenance of the device.
  • Page 5 Do not use the AC power source other than the one supplied by the manufacturer. Using a different power supply may seriously affect the safety of the user and device health. prohibited deform module electrostimulation. The device contains fragile components. Protect it from shocks.
  • Page 6 Attention! If the patient is running through a course of other physical therapy, use of the device is possible only under approval of attending physician. Transportation conditions: temperature from -50 °C to +50 °C, relative air humidity from 30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg Storage conditions: temperature from -50 °C...
  • Page 7 Attention! The device contains valuable materials, which can be used repeatedly after utilization with consideration of requirements of environmental protection. They shall be delivered to specially intended for this purpose places (consult with corresponding services in yoiur district) for collection and processing.
  • Page 8: Purpose Of The Device

    2. PURPoSE of THE DEVIcE The device DENAS-Vertebra-2 is intended for conduction of dynamic electrostimulation and electromassage by way of impact on different zones and areas of the back, and also for pain relief and correction of functional disturbances under diseases of different body organs. The device is intended for use in hospitals and in home conditions in accordance with the instructions of a physician.
  • Page 9: General Information On Method, Used In The Device

    3. GENERAl INfoRMATIoN oN METHoD, USED IN THE DEVIcE One of the most promising areas of modern medicine is use of physiotherapy for treatment and rehabilitation. Currently, there goes major distribution of complex technologies, such as neurostimulation (dynamic electroneurostimulation). The method consists in the therapeutic effects of short asymmetrical bipolar current pulses, shape of which varies depending on the electrical resistance of tissues ...
  • Page 10: Device Description

    4. DEVIcE DEScRIPTIoN Control panel Module of electrostimulation Connecting cable Set of contacts Fig. 1. Assembled device. Top view Cover of battery Jack for AC adaptor Warranty seal Cover of electronic module Fig. 2. Module of electrostimulation (bottom view of the part, which contains electronic unit)
  • Page 11 Button for selection of impact area Button for selection of impact mode Button for increase of impact power Button for decrease of impact power Button for switching the device on and off Fig. 3. Keyboard of control panel Presence of connection to AC Presence of adaptor...
  • Page 12: Indications And Contraindications For Use

    5. INDIcATIoNS AND coNTRAINDIcATIoNS foR USE 5.1 General purpose of the device The device can be used in following cases: — as the primary method of treatment under drug intolerance and contraindications for application of other methods; — as a component of  complex treatment in order to enhance the effect of primary drug, homeopathic, manual therapy as well as mental therapy and other methods of treatment;...
  • Page 13 5.3. Contraindications: — idiosyncrasy; — presence of an implanted pacemaker; — status epilepticus; — neoplasms of any etiology and distribution; — vein thrombosis; — acute agnogenic febrilty; — state of acute mental excitation of alcohol or drug origin. Attention!  There have been no  controlled researches on ...
  • Page 14 Programs of the device Period of Pro- Main zone of program Area of application gram impact operation (min.) 1. Treatment, rehabilita- tion, complementary pre- vention of chronic diseas- 2. Prevention and treat- ment of stress. Zone of the 3. Enhancement of adap- back at full tive capacity of organism А...
  • Page 15 Moderate and mild pain in the back, associated with spine injuries. Functional disorders, associated with Zone of the overexertion of back mus- back at the cles: fatigue, “choking” of level of cervi- muscles, etc. Chronic pain С cal spine, tho- syndromes under diseases 26 ±...
  • Page 16 disturbances of sleep at night insomnia, increased irritability, sexual dysfunction. * E program ends after the 9th phase (see. p. 9.5.5) in case if additional stimulation zone is not defined. This is not a malfunction of the system and depends on the current state of the organism of the patient.
  • Page 17 However, keep in mind that prolonged continuous use of a physical factor increases adaptation to it and may reduce the effectiveness of a treatment. In addition, the probabilistic nature of physiological processes in the body leads to lack of effectiveness for a small number (5%) of people or lack of favorable reactions from use of therapeutic factors.
  • Page 18: Conditions And Order Of Treatment

    6. coNDITIoNS AND oRDER of TREATMENT 6.1. General Provisions For applying of treatment with the help of the device, there is no need to observe any special conditions. The device should be placed in a warm room on a hard fl t surface (medical couch, floor), length and width ...
  • Page 19 Attention! Programs of the device consist of several phases,  which subsequently change  each other. Each phase has different parameters of stimulation, including  repetition rate  of impulses. Under changing of phases, subjective feeling of change of impact power level is possible. In case of appearance of sense of discomfort, adjust the power, using the appropriate buttons on control panel.
  • Page 20 The second, comfortable level - patient feels light pricking, vibration or light burning without pain. It is used under treatment of weak pain and aches of medium intensity. This is the most frequently used power level. The third, maximal level - patient feels expressed painful pricking or burning.
  • Page 21 Fig 5 — Connecting to AC adaptor Attention! It is prohibited to use the machine if it is damaged. Attention! It is prohibited to use the machine if indicators of control panel are damaged. Attention! If the device has been stored in cold environment or in high humidity conditions, keep it under normal room temperature for no less than 2 hours - before use .
  • Page 22 6.4. Order of conduction of treatment session 2. Switch on 1. Put safety sheet on the device the surface of module of with button electrostimulation and carefully secure it. 4. Select zone of impact 3. Select program of impact by by pressing button necessary number of pressing button...
  • Page 23 . Program are located in the menu in following order: program A → program B → program C → program D → program E → program A... 6.4.4. Selection of impact zone For programs, which are associated with necessity of selection of impact zone (programs B, C and D), use button .
  • Page 24 — holding of a button for more than 1 second will lead to consistent change of impact level. After selection of required level, release the button. Countdown of impact time will begin. For carrying out procedures using the device DENAS- Vertebra-2 it is recommended a few simple conditions: 1) Before the procedure, place the device on a flat surface.
  • Page 25 - slightly bend your knees. This is particularly important when lumbar lordosis strongly expressed in the spine and the electrodes do not touch the body; - maximum free from clothing the inpact area; - then restart the program; - in case of repeated interruption of any of the programs (especially when the program is interrupted after 2-3 minutes or more from the start of treatment), should change the program and carry out 1-2 sessions using...
  • Page 26 6.4.9. Completion of procedure For switched off device, remove napkin and treat electrode surface of unit of  electrostimulation with  standard disinfectant (e.g. 3% solution of hydrogen peroxide). In case of serious dirt accumulation on the module, it is allowed to treat the device with lint-free cloth, moistened with neutral and non-abrasive detergent.
  • Page 27: Technical Maintenance And Order Of Replacement Of Batteries

    7. TEcHNIcAl MAINTENANcE AND oRDER of REPlAcEMENT of bATTERIES Technical maintenance device should include following procedures: 7.1. External examination of the product. You must make sure that there are no traces of blows and falls, because it can result in incorrect operation of the device. 7.2.
  • Page 28 1. Take-off the cover of battery compartment and get used batteries. 2. Put new batteries, observing polarity. 3. Fix cover of battery compartment back into its place. Fig. 6. Order of replacement of batteries...
  • Page 29: Troubleshooting List

    8. TRoUblESHooTING lIST In this table conditions of the device are listed – which can be treated as malfunction and corrected independently. In case of other malfunctions, contact with representative of the manufacturer (see section 11 «Manufacturer’s warranty»), don’t try to correct them by yourself. Possible Method of Trouble...
  • Page 30 The device does not pass to mode Make sure that no of electrostimula- less than 60% of total tion under contact number of electrodes of built-in elec- in each zone of the trodes with skin. Insufficient area device are tightly ap- There is no symbol plied to the skin.
  • Page 31: Specifications

    9. SPEcIfIcATIoNS 9.1. Maximum current consumption of the device under supply voltage of 3,0±0,15 V: — in mode of electrostimulation – no more than 300 mA; — in switched off mode – no more than 100 uA. 9.2. Weight of the device without batteries: —...
  • Page 32 9.5.2. Program B Phase Frequency 140; 77; 60; 20 (Hz) Number of impulses per electrode Total time - 2 minutes. Phase length Every frequency works 30 seconds 9.5.3 Program C Phase Frequency 140 140 140; 77; 60; 20 (Hz) Number of impulses per electrode Total time - 2...
  • Page 33 9.5.5 Program E (continue) Frequency Number of impulses Phase length (min.) Phase (Hz) per electrode Total time - 2 minutes. Every 140, 77, frequency works 30 seconds 60, 20 9.5.6. Parameters of separate impulses of impact: Pulse form under connected load Z Parameters of load Z.
  • Page 34 Under minimum power level: — duration of positive part of impulse (T1f) - 32 ± 9 us; — amplitude of positive part of impulse (A1f) no more than 40 V; — impulse swing (Ap-p) no more than 70 V. Under maximum power level: —...
  • Page 35: Complete Set

    10. coMPlET SET Below you can see list of delivery for the device: Item Quantity, pcs. Device DENAS-Vertebra-02 Operations manual Safety sheet Battery of type LR6/AA AC adaptor Consumer’s container Manufacturer’s warranty is not applied for these accessories. Quantity can be increased.
  • Page 36: Manufacturer's Warranty

    11. MANUfAcTURER’S WARRANTY 11.1. manufacturer guarantees product requirements by TU 9444-013-44148620-2010, if the consumer observes conditions and rules of operation, storage and transportation. 11.2. Operating time of the device — 5 years. Under observance operation regulations, actual operating time can significantly exceed official. 11.3.
  • Page 37: Address Of The Manufacturer

    12. ADDRESS of THE MANUfAcTURER Address of company-manufacturer: LLC «RC ART» Academika Postovskogo st., 15 Ekaterinburg, 620146, Russia Official Distributors: www.denasms.com E‐mail: info@denasms.com...
  • Page 39: Warranty Maintenance Form

    ТАЛОН НА ГАРАНТийНый РЕмОНТ WARRANTY MAINTENANcE foRM GARANTIEREPARATURScHEIN Наименование / Name/ Bezeichnung: ДЭНАС- Вертебра-2 / DENAS-Vertebra-2 / DEDAS-Vertebra-2 Серийный номер изделия Serial number of device Seriennummer des Produktes________________________ Дата изготовления Manufacturing date Herstellungsdatum________________________________ Дата покупки Date of purchase Kaufdatum_______________________________________ Владелец Owner Eigentümer_______________________________________ Адрес...
  • Page 40 Причина отправки в ремонт Please explain the reason why device was sent for mainte- nance Grund für die Einsendung zureparatur_________________ _________________________________________________ _________________________________________________ _________________________________________________ Отметка о ремонте Note of completed maintenance Reparaturvermerk_________________________________ Подпись должностного лица предприятия, ответственного за приемку после ремонта / Signature of the authorized person in the company responsible for acceptance after maintenance / Unterschrift des fi meneigenen Prüfers nach der Reparatur _____________________________________________________...
  • Page 42: Acceptance Certificate

    СВидЕТЕЛьСТВО О ПРиЕмкЕ AccEPTANcE cERTIfIcATE AbNAHMEbEScHEINIGUNG ДЭНАС-Вертебра-2 признан годным для эксплуатации. The DENAS-Vertebra-2 has been found serviceable. Der DENAS-Vertebra-2 wird für betriebstauglich befunden. Отметка о приемке: Acceptance note: Abnahmevermerk: Дата продажи Date of sale Verkaufsdatum:___________________________________ Подпись продавца Signature of the seller Unterschrift des Verkäufers: _________________________ С...

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