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RITM OKB ZAO
TRANSCUTANEOUS ELECTROSTIMULATORS
CHANS-SCENAR, CHANS-01-SCENAR, CHANS-02-SCENAR,
CHANS-SCENAR-M, CHANS-01-SCENAR-M, CHANS-02-SCENAR-M,
SCENAR-1-NT (version 01), SCENAR-1-NT (version 02.1), SCENAR-1-NT (version 02.2),
SCENAR-1-NT (version 02.3), SCENAR-1-NT (version 03),
SCENAR-1-NT (version 01C), SCENAR-1-NT (version 02.1C), SCENAR-1-NT (version 02.2C),
SCENAR-1-NT (version 02.3C), SCENAR-1-NT (version 03C),
RITMSCENAR Expert, RITMSCENAR Expert C
Instruction for Use
MANUFACTURER
RITM OKB ZAO,
Petrovskaya 99, Taganrog, RUSSIA, 347900, tel/fax: +7 8634 623179
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
Notified Body No.2265
3EC International a.s.,
Hraničná 18, Bratislava, 82105, Slovakia
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Summary of Contents for RITM OKB ZAO RITMSCENAR Home
- Page 1 RITM OKB ZAO TRANSCUTANEOUS ELECTROSTIMULATORS CHANS-SCENAR, CHANS-01-SCENAR, CHANS-02-SCENAR, CHANS-SCENAR-M, CHANS-01-SCENAR-M, CHANS-02-SCENAR-M, SCENAR-1-NT (version 01), SCENAR-1-NT (version 02.1), SCENAR-1-NT (version 02.2), SCENAR-1-NT (version 02.3), SCENAR-1-NT (version 03), SCENAR-1-NT (version 01C), SCENAR-1-NT (version 02.1C), SCENAR-1-NT (version 02.2C), SCENAR-1-NT (version 02.3C), SCENAR-1-NT (version 03C),...
- Page 2 Instruction for Use Version 06 of 08.10.2019...
- Page 3 Instruction for Use Version 06 of 08.10.2019 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. WARNING! Simultaneous connection of a patient to a HF surgical equipment may result in burns at the site of the stimulator electrode and possible damage to the stimulator.
- Page 4 RITMSCENAR Home Device, RITMSCENAR Gorfinkel, SCENAR Gorfinkel), CHANS-02-SCENAR (Trade names RITMSCENAR Basic, SCENAR Basic), CHANS-SCENAR-M (Trade names RITMSCENAR Home D, SCENAR Home D), CHANS-01-SCENAR-M (Trade names RITMSCENAR Sport D, SCENAR Sport D), CHANS-02-SCENAR-M (Trade names RITMSCENAR Basic D, SCENAR Basic D) SCENAR-NT Models: ...
- Page 5 Instruction for Use Version 06 of 08.10.2019 Add-on electrodes: Face electrode Comb electrode Point electrode Special Snail electrode Bent point electrode Double facial Pawns electrode Double cosmetic electrode Double ophthalmic Goggles electrode ...
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Page 6: Table Of Contents
Instruction for Use Version 06 of 08.10.2019 CONTENTS 1. GENERAL GUIDELINES ..............................8 1.1 AIMS AND DEVICE PARAMETERS ..............................8 1.2 INDICATIONS AND CONTRAINDICATIONS FOR USE ......................9 1.2.1 INDICATIONS WITH REGARD TO PAIN RELATED TO: ..................9 1.2.2 CONTRAINDICATIONS/PATIENTS NOT SUITABLE FOR SCENAR TREATMENT ..........9 1.2.3 KNOWN SIDE EFFECTS ............................ - Page 7 Instruction for Use Version 06 of 08.10.2019 ADD-ON ELECTRODES ....................................20 ANNEX 2 GENERAL TREATMENT METHODS ............................. 23 1. INTRODUCTION ................................. 23 2. ‘THREE TRACKS, SIX POINTS’ METHOD ........................24 2.1 TREATMENT AREAS ....................................24 2.2 HOW TO CARRY OUT ‘THREE TRACKS, SIX POINTS’ METHOD IN SDM ................25 2.3 ‘TREE TRACKS, SIX POINTS’...
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Page 8: General Guidelines
Instruction for Use Version 06 of 08.10.2019 Approved by Director General RITM OKB ZAO Yury Starovoytov 08.10.2019 1. GENERAL GUIDELINES 1.1 AIMS AND DEVICE PARAMETERS All the CHANS-SCENAR models (hereinafter referred to as Home devices) are intended both for Professional healthcare facility environment and Home healthcare environment. -
Page 9: Indications And Contraindications For Use
Instruction for Use Version 06 of 08.10.2019 1.2 INDICATIONS AND CONTRAINDICATIONS FOR USE 1.2.1 INDICATIONS WITH REGARD TO PAIN RELATED TO: SCENAR devices are indicated to be used in professional medicine and at home in the following cases: to analgesic therapies in pains in bones, muscles, joints and ligaments; ... -
Page 10: Guidelines For Treatment
Instruction for Use Version 06 of 08.10.2019 2. GUIDELINES FOR TREATMENT 2.1 BASIC DEFINITIONS AND GENERAL TREATMENT METHODS The treatment is carried out by stimulating skin areas (hereinafter referred to as the ‘treatment areas’) with electrical pulses. The treatment areas should be determined before a session according to primary signs and complaints, and in the course of treatment according to secondary signs and complaints. -
Page 11: Guidelines For Treatment Modes And Methods Of Area Treatment
Instruction for Use Version 06 of 08.10.2019 change of a specific sound under the electrode. The treatment area on which a sound change has been the most perceptible should be stimulated additionally; ‘stickiness’ of the device. The device electrode is as ‘gluing’ to the skin that prevents from moving it. This effect depends on direction in which a device is moving. - Page 12 Instruction for Use Version 06 of 08.10.2019 In some cases an area can be treated in SDM by a constant method i.e. not moving and taking off the electrode from the skin surface until a session ends. If applying the labile method in SDM, the electrode should be set on the skin surface with a slight compression and, without delay, smoothly and not changing its compression, move it on the treatment area.
- Page 13 Instruction for Use Version 06 of 08.10.2019 Fig. 3...
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Page 14: Guidelines For Treatment Settings
Instruction for Use Version 06 of 08.10.2019 2.3 GUIDELINES FOR TREATMENT SETTINGS Power Power perception is very subjective. The following power levels can be classified according to patient’s sensations: a comfortable level (a patient feels a light tingling and vibration); ... - Page 15 Instruction for Use Version 06 of 08.10.2019 Frequency In degenerative processes (especially with painful manifestations) – use low frequencies (15-60 or 90 Hz) at the beginning of a session and higher frequencies (higher than 90 Hz) or the oscillating frequency mode at the end of a session.
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Page 16: Treatment Of A Complaint Area In Sdm And Idm
Instruction for Use Version 06 of 08.10.2019 Intensity, Damping, Gap – Delay between pulses in a batch. Only Professional devices provide an option to regulate these settings (see Operating Manual). Intensity means setting of pulses in a burst under a particular algorithm which enable a power level to be increased not changing a power level of particular stimuli. - Page 17 Instruction for Use Version 06 of 08.10.2019 minutes or till the sign intensity disappears/decreases. The secondary signs areas of larger surface should be treated in the same mode by moving the electrode from top to bottom and from the right to the left. If using Home devices in IDM, the area of the electrode setting (position) on which a dose has been completed within the shortest period shall be considered as an analogous area of the small asymmetry.
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Page 18: Potential Patient's Reactions To A Session
Instruction for Use Version 06 of 08.10.2019 2.5 POTENTIAL PATIENT’S REACTIONS TO A SESSION Sleepiness or, vice versa, a fit of energy may be observed within and after a session. Fever sensation, sweating may appear. Such vegetative reactions are typical for the treatment given by the devices of SCENAR series. -
Page 19: Treatment Of Acute And Chronic Low-Back Pains (Including Pains Appeared In The Prehospital Setting)
Instruction for Use Version 06 of 08.10.2019 If pains in a joint are intensive, start treatment from the joint which is symmetrical to an affected joint and then treat the affected joint. No more than two pairs of large joints can be treated within a session. If pain remains in a joint after the end of the general treatment, define the most painful point on this joint and treat it additionally. -
Page 20: Annex 1
Instruction for Use Version 06 of 08.10.2019 ANNEX 1 Add-on electrodes Comb electrode Face electrode Local electrode Point electrode... - Page 21 Instruction for Use Version 06 of 08.10.2019 Bent point electrode Special Snail electrode Double cosmetic electrode Double facial Pawns electrode...
- Page 22 Instruction for Use Version 06 of 08.10.2019 Double ophthalmic Goggles electrode Double facial Stamps electrode Special double Pencils electrode Single ophthalmic Monocle electrode Large comb electrode Multipurpose zonal electrode...
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Page 23: Annex 2 General Treatment Methods
Instruction for Use Version 06 of 08.10.2019 ANNEX 2 GENERAL TREATMENT METHODS 1. INTRODUCTION The general treatment methods should be used in the following cases: if it is expressly specified in indications for a specific disease; if a complaint can not be related to a specific skin area (insomnia, anxiety, psychoemotional tension and etc.);... -
Page 24: Three Tracks, Six Points' Method
Instruction for Use Version 06 of 08.10.2019 2. ‘THREE TRACKS, SIX POINTS’ METHOD 2.1 TREATMENT AREAS The method includes two treatment areas. The first area – three tracks i.e. three lines one of which is going along the backbone and other two lines goes in parallel of it on the right and on the left. The first track passes along the backbone spines, from the 7 cervical vertebra to the coccyx, then it continues from the hairy part of the head to the 7... -
Page 25: How To Carry Out 'Three Tracks, Six Points' Method In Sdm
Instruction for Use Version 06 of 08.10.2019 The second area – ‘six points’. These points are trigeminal nerve exit points on the face. Fig. 2 2.2 HOW TO CARRY OUT ‘THREE TRACKS, SIX POINTS’ METHOD IN SDM The manner to be observed while carrying out the method in SDM is almost the same for Professional devices and Home devices. -
Page 26: Tree Tracks, Six Points' In Idm
Instruction for Use Version 06 of 08.10.2019 If secondary signs are detected, treat them as specified in section 2.4 of the Instruction. Treat the second and the third track in the similar manner. Then, select the most pronounced sign among all secondary signs detected on the second and third tracks and treat this area additionally as specified in section 2.4 of the Instruction. - Page 27 Instruction for Use Version 06 of 08.10.2019 Select the most active area among three active areas on three tracks (according to the minimum period required till a completed dose) and treat it additionally three times till a completed dose but the frequency modulation mode should be switched on (the oscillating frequency).
- Page 28 Instruction for Use Version 06 of 08.10.2019 Select the next area which requires to be treated till zero in the similar manner by moving the device from one position to another and fix the current reaction value while finishing a completed zero. Select an area with the maximum value of the current reaction among the areas which have been treated till a completed zero and treat it in ‘FMVaR’...
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Page 29: Cervical-Collar Area' Method
Instruction for Use Version 06 of 08.10.2019 Warning! Reduce power to minimum before treating the face. Then, set the electrode on the side surface of the neck and increase the power level smoothly to reach its comfortable level. Then, you can start treating six points. -
Page 30: How To Carry Out 'Cervical-Collar Area' Method In Sdm
Instruction for Use Version 06 of 08.10.2019 Fig. 4 First, treat the cervical-collar are and, then, the forehead and adrenal glands projection. The device electrode should be set vertically. 3.2 HOW TO CARRY OUT ‘CERVICAL-COLLAR AREA’ METHOD IN SDM The manner to be observed while carrying out the method in SDM is almost the same for Professional devices and Home devices. - Page 31 Instruction for Use Version 06 of 08.10.2019 The scheme to be observed while moving the electrode is given in Fig. 5. Fig. 5 Repeat treatment till secondary signs appear but not more than five times. If secondary signs are detected, treat their manifestation areas as specified in section 2.4 hereof.
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Page 32: How To Carry Out 'Cervical-Collar Area' Method In Idm
Instruction for Use Version 06 of 08.10.2019 Treat secondary signs areas on each side of the forehead additionally as specified in section 2.4 hereof. Treat the area of the adrenal glands projection by moving the electrode for short distance. First – in the left, then –... -
Page 33: Method Of 'Palms'. Treatment Areas And Procedure
Instruction for Use Version 06 of 08.10.2019 The area on which the treatment till a completed dose requires more time should be treated three times in sequence till a completed dose and the frequency modulation mode (the oscillating frequency) should be switched on. The area of the adrenal glands projection is located in the point of crossing of a line passing down from the sharp scapula edge with the last rib. - Page 34 Instruction for Use Version 06 of 08.10.2019 Fig. 6 The power level is comfortable and the frequency is standard. After treatment areas are determined, treat them in SDM or IDM as areas of complaint projection (see section 2.4 hereof).
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Page 35: Abdomen' Method
Instruction for Use Version 06 of 08.10.2019 5. ‘ABDOMEN’ METHOD 5.1 TREATMENT AREAS Determine treatment areas. To do this, divide the abdomen surface area imaginatively into equal quadrants with an omphalus located in the center (Fig. 7). Treat the center of each quadrant in IDM one time till a completed dose (for Home devices) from the left top or till an IR value appears on the display (for Professional devices). -
Page 36: Indications And Procedure For Treatment Of The Liver Projection Area
Instruction for Use Version 06 of 08.10.2019 6. INDICATIONS AND PROCEDURE FOR TREATMENT OF THE LIVER PROJECTION AREA The dynamics of a patient recovery in treating many diseases mainly depend on the functional status of the liver. So, the liver projection is recommended to be used additionally to the basic areas scheme.
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