RITM OKB ZAO SCENAR Home Operating Manual
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RITM OKB ZAO SCENAR Home Operating Manual

Transcutaneous electrostimulators
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RITM OKB ZAO
TRANSCUTANEOUS ELECTROSTIMULATORS
SCENAR Home,
SCENAR Sport,
SCENAR Basic
OPERATING MANUAL
MANUFACTURER
RITM OKB ZAO
99, Petrovskaya str., Taganrog, Russia, 347900
Tel/Fax: +7 (8634) 62-31-79
www.scenar.com.ru e-mail: medsc@scenar.com.ru
AUTHORIZED REPRESENTATIVE
SCENAR Center – Bulgaria ltd.
9, V. Aprilov blvd. Plovdiv, 4002, Bulgaria
phone: (+3-59-32) 641-001 e-mail: office@bgscenar.org

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  • Page 1 RITM OKB ZAO TRANSCUTANEOUS ELECTROSTIMULATORS SCENAR Home, SCENAR Sport, SCENAR Basic OPERATING MANUAL MANUFACTURER RITM OKB ZAO 99, Petrovskaya str., Taganrog, Russia, 347900 Tel/Fax: +7 (8634) 62-31-79 www.scenar.com.ru e-mail: medsc@scenar.com.ru AUTHORIZED REPRESENTATIVE SCENAR Center – Bulgaria ltd. 9, V. Aprilov blvd. Plovdiv, 4002, Bulgaria...
  • Page 2 Operating Manual Version 6.3-04 of 10.10.18 IMPORTANT INFORMATION! PLEASE READ THIS PAGE CAREFULLY WARNING! This device should NOT be used on an individual who has a heart pacemaker or other electrically powered implant fitted. WARNING! Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
  • Page 3 Operating Manual Version 6.3-04 of 10.10.18 Origin: RITM OKB ZAO, 99, Petrovskaya str., Taganrog, Rostov region, 347900, Russia. Model(s): SCENAR Home, SCENAR Sport, SCENAR Basic. Classification: Type of protection against electric shock – Internally powered equipment (9 V battery) Degree of protection against electric shock –...

  • Page 4: Marks And Symbols On The Device Label

    Operating Manual Version 6.3-04 of 10.10.18 MARKS AND SYMBOLS ON THE DEVICE LABEL THIS CE SYMBOL CERTIFIES THAT THE PRODUCT COMPLIES WITH THE ESSENTIAL REQUIREMENTS OF THE MEDICAL DEVICE DIRECTIVE Notified Body No.2265 3EC International a.s., Hraničná 18, Bratislava, 82105, Slovakia APPLIED PARTS –...

  • Page 5: Definitions

    Operating Manual Version 6.3-04 of 10.10.18 DEFINITIONS Amplitude modulation (Am) is a periodic variation of stimuli amplitude (as well as stimuli Energy). Am is defined as the ratio of the time the device is sending pulses with preset Energy to that with minimal En- ergy.

  • Page 6: Table Of Contents

    1 PURPOSE ......................7 2 SPECIFICATIONS .................... 8 3 PACKAGE CONTENTS ................. 11 4 SCENAR DEVICE OVERVIEW ..............12 4.1 SCENAR HOME ..................12 4.2 SCENAR SPORT ..................16 4.3 SCENAR BASIC ..................21 5 GETTING STARTED ..................23 5.1 SCENAR HOME ..................23 5.2 SCENAR SPORT ..................

  • Page 7: Purpose

     SCENAR Basic transcutaneous dual-mode electrostimulator with individual dosing of reflex zone stimulation. SCENAR Home, SCENAR Sport, SCENAR Basic transcutaneous electrostimulators (hereinafter called the SCENAR device or the device or SCENAR) are intended for general therapeutic non-invasive treatment of...

  • Page 8: Specifications

    Operating Manual Version 6.3-04 of 10.10.18 2 SPECIFICATIONS 2.1 Power supply: one 9 V alkaline battery. 2.2 Current consumption: max – 85 mA. 2.3 At a load (see Fig.1) SCENAR performs:  generation of two-phase stimuli without a DC-component (see Fig.2) with a waveform depending on the skin impedance under the electrode (see Fig.3 through 5);...
  • Page 9 Fig.4 Fig.5 2.4 Fixed stimuli frequencies:  SCENAR Home – 90 Hz 10 %;  SCENAR Sport – 14, 60, 90, 340 Hz 10 %;  SCENAR Basic – 60, 90 Hz 10 %. 2.5 Frequency modulation (‘Fm’) with the following parameters (only for SCENAR Home and SCENAR Sport): ...
  • Page 10 – stimuli burst duration Fig.6 2.7 Time of dosed stimulation with L1 load:  SCENAR Home – 20 to 40 sec;  SCENAR Sport – 30 to 60 sec;  SCENAR Basic – 45 to 75 sec. 2.8 SCENAR device automatic turn-off time – (60 ± 20) sec.

  • Page 11: Package Contents

    3 PACKAGE CONTENTS See Table 1 for SCENAR complete delivery set: Table 1 Quantity, Item units SCENAR Home – a biofeedback transcutaneous  electrostimulator with individual dosing of reflex zone stimulation SCENAR Sport – a transcutaneous triple-mode  electrostimulator with individual dosing of reflex zone stimulation SCENAR Basic –...

  • Page 12: Scenar Device Overview

    Operating Manual Version 6.3-04 of 10.10.18 4 SCENAR DEVICE OVERVIEW 4.1 SCENAR HOME Fig.7 shows the SCENAR Home device exterior. Fig.7 4.1.1 On the back side of the casing (1) there is a built-in electrode (2) and a battery cover (12).
  • Page 13 Operating Manual Version 6.3-04 of 10.10.18  10 – ‘ ’ button – activates the preselected mode or increases the energy level (stimulus strength);  11 – ‘ ’ button – deactivates the preselected mode or decreases the energy level (stimulus strength). 4.1.4 On the left side of the casing there is a jack (13) intended for connecting the add-on electrodes which can be supplied additionally up- on request.
  • Page 14 Operating Manual Version 6.3-04 of 10.10.18 (Optional) Also while the ‘D’ LED is blinking, the ‘D2’ mode can be selected by pressing the ‘ ’ button (sequence of single taps). The activa- tion of the ‘D2’ mode is indicated by two short beeps and short intermit- tent flashes of the ‘D’...
  • Page 15 Operating Manual Version 6.3-04 of 10.10.18 ATTENTION! In fact there is a double indication: a relative val- ue of current reaction to initial one – by LEDs and sounds, and an absolute maximum of reaction – by clicks. 4.1.7 To set the AM mode, press the ‘ ’ button (sequence of single taps) until the ‘Am’...

  • Page 16: Scenar Sport

    Operating Manual Version 6.3-04 of 10.10.18 (Optional) For user’s convenience SCENAR provides the quick access to the Preset 2. For this purpose press the ‘ ’ and ‘ ’ buttons simultane- ously. 4.1.10 Enabling/disabling sounds:  to enable sounds, press the ‘ ’ and ‘ ’ buttons simultaneously (the SCENAR device emits a beep);...
  • Page 17 Operating Manual Version 6.3-04 of 10.10.18 4.2.2 On the front side of the casing there are following indicators:  3 – ‘ ’ LED – indicates the energy level (stimulus strength);  4 – ‘F’ LED – indicates the stimulation frequency preselecting; ...
  • Page 18 Operating Manual Version 6.3-04 of 10.10.18 A long beep indicates the upper energy level limit. The energy level decrease is accompanied by clicks at the adjustment rate, the decrease of the ‘ ’ LED brightness and the ‘D’, ‘Am’ and ‘Fm’ LEDs going out one after another, as shown above.
  • Page 19 Operating Manual Version 6.3-04 of 10.10.18 When the dose is reached, all the LEDs flash on shortly and a two- tone beep sounds. (Optional) The ‘D2’ mode is intended for searching skin areas with maximal reaction in a labile mode. If the current reaction exceeds the pre- vious maximum, this is indicated by a clicking sound.
  • Page 20 Operating Manual Version 6.3-04 of 10.10.18  90 Hz – three beeps;  340 Hz – four beeps. Once a new frequency is set, the ‘ ’ LED brightness changes. When the ‘Fm’ mode is on, the frequency set in the ‘F’ mode is disre- garded and the frequency selection is blocked.

  • Page 21: Scenar Basic

    Operating Manual Version 6.3-04 of 10.10.18 4.2.13 To switch the SCENAR device on with the energy level set be- fore it was switched off press and hold the ‘ ’ and ‘ ’ buttons (for about 2 sec), until the SCENAR device emits an intermittent high-pitch beep. ATTENTION! When the SCENAR device is switched on with the energy level set before it was switched off, the sound indication is different from default.
  • Page 22 Operating Manual Version 6.3-04 of 10.10.18 4, 5, ‘F1’, ‘F2’ – from 76 to 100 %;  to display current reaction to the initial reaction ratio in the ‘F2’ (screening) mode. 4.3.3 On the front side of the casing there are following buttons: ...

  • Page 23: Getting Started

    ATTENTION! Remove the protective film from the built-in elec- trode before using the SCENAR device. 5.1 SCENAR HOME 5.1.1 Remove the battery cover and insert the battery observing polarity. If the battery is installed correctly a beep sounds and the ‘...
  • Page 24 Operating Manual Version 6.3-04 of 10.10.18 ATTENTION! DO NOT use any power adapters to power the SCENAR device from the line supply. 5.1.2 The SCENAR device can be reset in case of failure or when it is required to rapidly return to the default settings: ...

  • Page 25: Scenar Sport

    Operating Manual Version 6.3-04 of 10.10.18 5.1.8 Cleaning & Disinfecting: Wipe the outer surface of the SCENAR device with a cotton swab dampened with 3 % hydrogen perox- ide solution with the addition of 0.5 % solution of an approved cleaning liquid.

  • Page 26: Scenar Basic

    Operating Manual Version 6.3-04 of 10.10.18 ly (approximately twice a second), indicating that the battery should be replaced (refer to item 7.2). Otherwise, the manufacturer shall bear no liabil- ity for incompliance of the SCENAR device performance with the specifica- tions stated in this Operating Manual.

  • Page 27: Using Scenar Device

    0.5 % solution of an approved cleaning liquid. Allow to dry up thoroughly before use. 6 USING SCENAR DEVICE 6.1 SCENAR HOME 6.1.1 The Instruction for is the main document to be consulted with when delivering treatment with the SCENAR device.

  • Page 28: Scenar Sport

    Operating Manual Version 6.3-04 of 10.10.18 ATTENTION! The SCENAR device switches itself off after 60 seconds if no button has been pressed and there is no skin contact. 6.1.4 When the treatment is over, it is recommended to reset to de- fault settings (refer to item 5.1.2).

  • Page 29: Maintenance

    It is recommend- ed to reset the SCENAR device to the default settings in accordance with:  item 5.1.2 for SCENAR Home,  item 5.2.2 for SCENAR Sport,  item 5.3.2 for SCENAR Basic.

  • Page 30: Troubleshooting

    Reset the SCENAR device to does not operate in function. the default settings in accord- accordance with item ance with: 5.1.3 (for item 5.1.2 for SCENAR Home), SCENAR Home, 5.2.3 (for item 5.2.2 for SCENAR Sport) SCENAR Sport, 5.3.3 (for item 5.3.2 for SCENAR Basic).
  • Page 31 Operating Manual Version 6.3-04 of 10.10.18 Continue table 2 Fault Possible cause Suggested solution The SCENAR device The energy level Increase the energy level until operates but there is no is too low. comfortable sensations ap- energy on the built-in pear.

  • Page 32: Warranty

    Operating Manual Version 6.3-04 of 10.10.18 9 WARRANTY 9.1 The manufacturer guarantees that the SCENAR device complies with this Operating Manual when operated under the conditions specified. 9.2 The warranty period is 24 months from the date of purchase. 9.3 In case of malfunction during the warranty period, the SCENAR device with the Warranty card shall be returned to the manufacturer.

  • Page 33: Transportation And Storage

    Operating Manual Version 6.3-04 of 10.10.18 10 TRANSPORTATION AND STORAGE 10.1 The transportation of the SCENAR devices to a customer may be carried out by all kinds of covered vehicles, except for the plane compart- ments that have no heating, at the air temperature from –50 C to +50 C and relative humidity 100 % at a temperature of 25 C with a protection from a direct atmospheric precipitation.

  • Page 34: Annex 1

    Operating Manual Version 6.3-04 of 10.10.18 ANNEX 1 Guidance and manufacturer's declaration – electromagnetic compatibility (EMC) Intended healthcare environments – Professional and Home Emissions — Classification Standard EN 55011 (idt CISPR 11) — Class A or B — Group 1 or 2 Conducted RF Emissions NOTE 1 Radiated RF Emissions...
  • Page 35 Operating Manual Version 6.3-04 of 10.10.18 Guidance and manufacturer's declaration – electromagnetic immunity EN 60601-1-2 Compliance Immunity test test level level ± 8 kV contact Electrostatic discharge (ESD) PASS ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air EN 61000-4-2 Radiated RF EM fields EN 3 V/m (for Professional...

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