ТРТК 04.3-03.70 РЭТУ 9444-009-44148620-2009

TRONITEK LLC, Yekaterinburg, Russia

5th generation of device

Operating ManualPart II. Usage Instruction

The company quality management systemis in compliance with ISO 9001 and ISO 13485

DENAS® PCM 2015English

Russian

French

German

EXTRACT

TABLE OF CONTENTPurpose. ..............................................................................3Safety Regulations. ..........................................................4Carrying out treatment procedure ............................9

1. General information. ..............................................92. Indications and contraindications

for use.............................................................................103. Conditions for treatment....................................134. Treatment by device. ...........................................13

Appendix A Atlas of zones for work with menu: «Programs». .....35

Appendix B Atlas of zones for work with menu: «Frequencies» 68

3

PURPOSE

Transcutaneous electrostimulator DENAS PCM is designated for general regulatory impact on the whole body as well as the treatment of different functional disorders and diseases. The method of dynamic electro neuro stimulation influences biologically active points and zones with electric impulses. There is an opportunity to choose an individual treatment program as well as ready inbuilt programs. The device has inbuilt electrodes and a jack for external applicators.

The DENAS PCM unit can be used at home for treatment and for prevention cause according to doctor’s recommendations.

21 Basic user program settings(modes, frequencies and duration of stimulation are setting up automatically)

Name ofprogram* Zones for stimulation Duration of

stimultaionModes,

frequencies, Hz

ALLERGYEpigastric zone of stomach 10 7710; 3,8

Zone of the 7th cervical vertebra 15 77; 1,7; 3,8

PAIN Painful zone 15Special

modulated mode

SEVERE PAIN Painful zone 15

BLOATING Front abdominal wall 10 7710NEURO-CIRCULATORY DYSTONIA Neck and collar zone 20 7710; 10; 2,5

Special modulated mode

Please see Russian-English translation on pages 27-28 of Operating Manual Part 1 “Technicalpassport”

22

HYPERTENSIONZone of the 2nd cervical vertebra 5 7710

Zone of the 7th cervical vertebra 5 7710

HYPOTONIA Neck and collar zone 5 77АМ

HEAD

Zone of the 2nd cervical vertebra 5 60

Neck and collar zone 5 60Hand: the zone according to Su-Jok 5 60

THROATHand: the zone according to Su-Jok 10 60

Sub-jaw zone 10 77

GYNECOLOGICPAIN* Painful zone of stomach 15 7710; 3,8; 4,0

GYNAECOLOGY*

Soles of feet 15 2,5; 4,0; 9,4

Neck and collar zone 15 7710

Lumbosacral zone 10 10; 20

* Not available when function "Baby doctor" is on.

23DIARRHEA

Front abdominal wall 10 77

Lumbosacral zone 10 60; 20

GASTROINTESTINAL PAIN Painful zone of stomach 15 7710; 3,8; 5,9

CONSTIPATIONFront abdominal wall 10 77

Lumbosacral zone 10 60; 20

COUGHSub-jaw zone 5 7710

Zone of jugular fossa 15 60; 8,0

MUSCLES Affected or painful zone 15Special

modulated mode

COLDHand: the zone according to Su-Jok 10 60

Wings of nose and zone around nose 10 77

24

POTENCY*

Lumbosacral zone 15 2,6; 4,0; 9,4

Neck and collar zone 15 7710

Soles of feet 10 10; 20

KIDNEYSLumbosacral zone 20 77; 20

Soles of feet 15 2,8; 8,1; 7710

BACK Projection of spinal column painful zone 15 140; 77; 20

JOINTSAffected joint 20 140; 77; 20; 1,6

Segmental zone 10 7710

NAUSEA Epigastric zone, left and righthypochondrium 10 7710

TRAUMA Affected zone 15 200; 140; 77

ASTHMAZone of jugular fossa 10 7710

Zone of the 7th cervical vertebra 9 1,0; 8,0; 3,6

* Not available when function "Baby doctor" is on.

4.4.2. FrequenciesUsing the menu

With the help of navigation buttons and select in main menu item «Frequencies» and confirm your choice by pressing the button .

and , In this section find required frequency of impact with button make a selection and press button .

25

35

Appendix AAtlas of zones for workwith menu : «Programs»

39

1. Stimulation area by inbuilt electrodes of the device

2. External electrode placement

4. Method of application Labile-stabileStabile, with the help of applicator

5. Device power level / Patient’s sensation Minimal / Lack of sensations Comfortable / Pleasant pricking Maximal / on the pain threshold

Notation Conventions

123

45

3. The name of stimulating area

Zone 1: Neck and collar zone

LabileStable

40

Allergy. .............................................................44

Hypertension. ... . 51

Hypotonia......... .52

Joints.....................................................................64

Asthma.............................................................67

Bloating. .........................................................48

Diarrhea. .........................................................55 Kidneys. ...........................................................62

Head.................... ............53

Alphabetical list of programs

Pain. .......................................................................45

Gynecological pain............................49 Neuro-circulatory dystonia......47

Severe Pain. ................................................46

Throat. ...............................................................54

Muscles. ...........................................................59

Potency.............................................................61

Back. ....................................................................63

Nausea. ..............................................................65

Trauma. ............................................................66

Cold......................................................................60

Constipation. ............................................57

Cough. ..............................................................58

Gynecology ................................................50

Gastrointestinal pain.......................56

41

Acute respiratory diseases.

..........................................................................60, 71Algomenorrhea.........................49, 101Allergy. ...............................................44, 109Antritis...............................................................79Anxiety. ............................................................47 Arterial hypertension. ......51,125Arterial hypotonia..............52, 127Arthritis, arthrosis......................64, 89Asthma...................................................67, 75 Astigmatism..........................................133Bloating. ...............................................48, 81Bronchial asthma ....................67, 75

Bronchitis......................................................73Burn......................................................................95Cataract. ......................................................133Cold, rhinitis..............................................60Cellulitis, obesity...............................113Constipation. ............................................57Coronary heart disease. ..........123Cosmetology..........................111, 113Cough. ..............................................................58Cystitis. .............................................................62Deafness, tinnitus. ..............................79Dermatitis..................................................109Diabetic angiopathy. .................131

Diarrhea. .........................................................55Diskogenic radiculopathy.....63Dislocations of joints. ....................93Eczema. ........................................................109Edema in legs. .....................................129Essential hypertension. ..51,125Eyestrain.....................................................133Face care. ...................................................111Fever................................................................141 Fractures. .......................................................66Frontitis. .................................................60, 71 Glaucome. .................................................133Headache...........................53, 115, 145

Alphabetical list of diseases

42

Hemorrhoids. ...........................................87Hyperopia. ...............................................133Hypogalactia. .......................................103

Insomnia. ...................................................121Lactostasis. ..............................................103Laryngitis. .....................................................77Logoneurosis, stammering.

................................................................................119Lumbodynia...................................45, 46 Mastitis.........................................................103Menstrual disorders. .......................50Migraine...........................................53, 115Myocardiodystrophy.................123

Myopia. ................................................133Nausea. .............................................................65Neuralgia-trigeminal ................117Neurodermatosis. ...........................109Neurosis, stress......................................47 Osteoarthritis. ..............................64, 89Painful urination. .................................97Pain in back................................................63Pain in ear.....................................................79Pain in face. .............................................117Pain in joints...................................64, 89Pain in legs. .............................................131

Pain in throat............................................54

Pain in the zone of heart. ... 123 Pharyngitis. .................................................71Potency disorders. .............................61Prostatitis. .................................................107Refractive disorders.....................133Sciatica................................. 46, 59Sensorineural deafness...............79Soft tissue bruise.................................66Sprain.................................................................93Stammering...........................................119Sterility....................................................50, 61Stomach-ache.........................................56Syncope. .....................................................139Tonsillitis........................................................77

Alphabetical list of diseases

43

Toothache.................................................135Tracheitis........................................................77Trauma of joints. ........................64, 66

Urethritis. .........................................97, 144Urination disorders. .........................97Urolithiasis..........................45, 46, 143

Varix. ................................................................129Vertigo. ..........................................................116Wound..............................................................95

Alphabetical list of diseases

45Program PAIN

Pain: painful zone. Zone of maximal pain is stimulated by inbuilt or external electrodes

46 Program SEVERE PAIN

– severe pain

– aching dull pain

Pain: painful zone. Zone of maximal pain is stimulated by inbuilt or rexternal electrodes

68

Appendix BAtlas of zones for work with

menu: «Frequencies»

70Notation Conventions

2. Sequence of zones’ stimulation

1. Main zones – for obligatory stimulation. Additional zones are stimulated to boost the therapy effect.

5. Device power level / Sensations of a patientMinimal / Lack of sensationsComfortable / Pleasant prickingMaximal / on the pain threshold

6. Duration of procedure4-510-15 min. Stimulate zone for 10–15 minutes, 4–5 times a day.

4. Method of applicationLabile Stabile

Labile-stabileStabile, with the help of applicator

3. Selection of mode in menu Menu

77 Hzor other modes

1. Wings of nose andzone around nose77 Hz

123

456

Mai

n zo

nes

timesa day

10-15 min. timesa day4-5

89 Pain in the jjjoints (arthritis, arthrosis)Ba

siс

zone

s

2. Neck and collar zone — in case of injured upper extremitiesLumbosacral zone— in case of lower extremities

10 Hz

1. Zone of injjjured jjjoint

77 Hz, 140 Hz

— severe pain

— aching dull pain

5-10 min. timesa day2-3

10-15 min. timesa day2-3

90Pain in the jjjoints (arthritis, arthrosis)

1. The same zone on a healthy jjjoint ofthe symmetrical extremity

2. Hand: the zone according to Su-Jok

10 Hz77 Hz

Note. Duration of course — until recovery, but not less than 7 days.

Affected side

Healthy side

Supp

lem

enta

ry z

ones

5 min. timesa day1-2 5-10 min. times

a day1-2

91Ba

siс

zone

sPain in the neck and back(spinal osteochondrosis, diskogenic radiculopathy, lumbodynia, sciatica)

1. Cervical spine— pain in the neck77 Hz, 140 Hz

— severe pain

— aching dull pain

2. lumbosacral , thoracic spine— pain in the back77 Hz, 140 Hz

— severe pain

— aching dull pain

5-30 min. timesa day1-2 5-30 min. times

a day1-2

92Pain in the neck and back

(spinal osteochondrosis, diskogenic radiculopathy, lumbodynia, sciatica)

Supp

lem

enta

ry z

ones

1. Neck and collar zone— pain in the neck

2. Painful zone— pain in the back

9,6 Hz 9,6 Hz

Note. Duration of course — until recovery.

5-15 min. timesa day1-2 5-15 min. times

a day1-2