DENAS PCM User manual

TRONITEK LLC, Ekaterinburg, Russia
Multipurpose Transcutaneous Electrical Stimulator
Operating Manual
T 04.403.71 
T 9444009441486202009
Registration Certicate for medical device of the Federal Agency for Supervision of Health Care Service
№ ФСР 2009/06316.
DENAS®PCM
Россия/
Russia
ЕС, все
страны/
EU, all
США/
USA
Канада/
Canada

CONTENTS
Part I. Technical Passport
1 Safety Rules..........................................................................................5
2 Purpose..................................................................................................10
3 Technical Parameters..............................................................11
4 Package Contents.......................................................................24
5 Elements of the device........................................................25
6 Sequences Using the Device.........................................34
7 Using Menu.......................................................................................36
8 Maintenance.....................................................................................64
9 Battery Replacement Procedure.................................66
10 Troubleshooting........................................................................67
11 Manufacturer Warranty.....................................................72
Part II. Application instructions
1 Conducting treatment procedures............................76
Annex А. Accessories....................................................................101
Annex B.
Zone Atlas for Using Programs Menu...........................107
Alphabetical Index of Programs..................................111
Alphabetical List of Diseases............................................112
Annex C.
Zone Atlas for Using Frequency Menu...........................139

PART I
Technical passport

4Thank you for buying DENAS-PCM device!
For ecient and safe use of the device, it is necessary to read all the chapters of this
Operating Manual.

5
1 SAFETY RULES
The information contained in this Operating Manual is important for your
safety and correct use and maintenance of the device.
The device is safe in service as it uses low voltage current source isolated from the
applied part (B type item with F type applied part).
It is not allowed to use the device for treatment of patients with implanted
electronic devices (such as a heart pacemaker) or patients with idiosyncrasy of
electric current.
It is prohibited to apply the device in direct projection of the heart in the front.

6It is not advisable to connect the patient to any other high frequency electrical
devices during the stimulation. Simultaneous application of the device with
another electrical equipment may lead to burns or possible damage of the
device.
If the device is used near short wave or microwave equipment, it may result in
instability of the device output parameters.
It is prohibited to connect the device to any other devices except for external
electrodes produced by the manufacturer.
It is prohibited to use external mains supply. Any partial or full dismantling of the
device, as well as any modications in the device are prohibited.

7The device contains fragile elements. Keep it from blows.
Keep the device away from continuous direct sunlight at high ambient
temperature (above 25 °C). Keep the device away from heating appliances.
The device is not waterproof. Keep it away from humidity.
Specialists qualied by the manufacturer only should perform any repair works
of the devices. Any partial or full dismantling of the device, as well as any
modication in the device are prohibited.

8Transport Conditions: temperature of 50°С below zero to 50°С above zero,
and atmospheric pressure of 70 to 106 kPa (525-to795 mm Hg).
Storage Conditions: temperature of 50°С below zero to 40°С above zero, and
atmospheric pressure of 70 to 106 kPa (525-to795 mm Hg).
Operating Conditions: temperature of 10°С above zero to 35°С above zero,
and atmospheric pressure of 70 to 106 kPa (525-to795 mm Hg).
Attention! If the device has been stored at temperature 10°С below the ambient
air temperature, leave it at a temperature of application environment for a
minimum of two hours before using.
-50 °С
+50 °С
-50 °С
+40 °С
+10 °С
+35 °С

9Relative air humidity of 30 to 93 %.
Waste Disposal: packaging materials do not have adverse impact on the
environment; they could be recycled.
The device and batteries should be disposed of according to the established
disposal rules for electronic devices.
The device contains valuable materials, which could be used after recycling subject
to environment protection requirements. They should be taken to specialized waste
collection and disposal centers (consult the relevant agencies at your region).
It is technically feasible to dispose of the device. The device does not pose
any hazard to life or health of people or to environment after the expiry of its
service (product) life and it does not require any special measures to prepare or
send its components for disposing.
30 %
93 %

10 2 PURPOSE
DENAS-PCM Multipurpose Transcutaneous Electrical Stimulator is designed to exert general
regulating impact on physiological systems of human body and to treat functional disorders
of a wide range of illnesses. Application of electric current impulses on biologically active
points and zones of human body perform dynamic electrical nerve stimulation. The device
also allows to select an individual treatment program or to choose among the existing
programs. The device has in-built electrode and a connector for external therapeutic
electrodes*.
DENAS-PCM device can be used at healthcare centers and at home according to doctor’s
instructions.
The device should only be connected to external electrodes produced by the manufacturer (see Annex А).
*

11
3 TECHNICAL PARAMETERS
3.1 Electrical impulses of the device have the following output parameters:
3.1.1 When load = 20 kOhm
Capacity (in standard units) Minimum* Maximum**
1 99
Amplitude of phase 1, B ≤ 40 ≤ 40
Duration of phase 1, ms 6,0 ± 1,5 400 ± 100
Amplitude of phase 2, B 9,0 ± 2,5 450 ± 113
The above stated parameters apply to treatment mode impulses and do not apply to test impulses.
Parameters should be measured when Therapy without Contact Control Function is enabled.
Parameters should be measured when Children’s Doctor Function is disabled.
*
**

12 3.1.2 Relation of the impulse shape to load resistance with medium and maximal
capacity level.
10 units 99 units
2 kOhm

13
20 kOhm
Z1
R1 82±5% kOhm
R2 2±5% kOhm
С1 3300±20% pF
С1
R2R1

14
3.2 The device allows setting the following impulse frequencies, Hz:
3.2.1 Range 1: 1.0 to 9.9 with pitch of 0.1±0.05.
3.2.2 Range 2:
— 10±1, including MED (preventive treatment) and Screening modes and Programs
Menu;
Z2
R1 56±5% kOhm
R2 470±5% kOhm
С1 6200±20% pF
С1
R2R1

15— 20±2;
— 60±2;
— 77±3;
— 77±3 and 10±2 modulated with frequency of 2±0.1 (frequency «7710»);
— 77±3 with amplitude modulation (frequency «77АМ»);
— 77±3 (2,0±1,0 s) и 20±2 (3,0±1,5 s) (frequency «7720»);
— 125±4;
— 140±5;
— 200±5.
3.3 Special stimulation programs.
Program name Application zone / frequency / duration Age
ALLERGY Zone 1: «7710» (5 min) + 3,8 Hz (5 min)
Zone 2: 77 Hz (5 min) + 1,7 Hz (5 min) + 3,8 Hz (5 min)
over 7
years
PAIN Zone 1: Impulses with quasirandom repetition frequency charge with
in the range of 75 to 135 Hz (15 min)
over 1
years

16
INTENSE PAIN
Zone 1: Impuls packets with repetition frequency of 77 Hz
and variable duration and carrier frequency: from 2.5 msec
and 27 кHz at minimum power level up to 1.0 msec and 2.8
кHz at maximum power level (15 min)
over 7 years
BLOATING Zone 1: «7710» (5 min) + 125 Hz (5 min) any age
DYSTONIA Zone 1: «7710» (10 min) + 10 Hz (5 min) + 2,5 Hz (5 min) over 4 years
GYNECOLOGICAL PAIN Zone 1: «7710» (5 min) + 3,8 Hz (5 min) + 4,0 Hz (5 min) over 13 years
GYNECOLOGY
Zone 1: 2,5 Hz (5 min) + 4,0 Hz (5 min) + 9,4 Hz (5 min)
Zone 2: «7710» (15 min)
Zone 3: 10 Hz (5 min) + 20 Hz (5 min)
over 13 years
HYPERTENSION Zone 1: «7710» (5 min)
Zone 2: «7710» (5 min) over 7 years
HYPOTONIA Zone 1: «77АМ» (15 min) over 7 years
HEAD
Zone 1: 60 Hz (5 min)
Zone 2: 60 Hz (5 min)
Zone 3: 60 Hz (5 min)
over 7 years

17
THROAT Zone 1: 60 Hz (10 min)
Zone 2: 77 Hz (10 min) over 4 years
DIARRHEA Zone 1: 125 Hz (10 min)
Zone 2: 20 Hz (5 min) any age
ABDOMINAL PAIN Zone 1: «7710» (5 min) + 3,8 Hz (5 min) + 5,9 Hz (5 min) over 4 years
CONSTIPATION Zone 1: 125 Hz (10 min)
Zone 2: 20 Hz (5 min) any age
COUGH Zone 1: «7710» (5 min)
Zone 2: 60 Hz (10 min) over 1 years
MUSCLES
Zone 1: Impuls packets with duration of 380±38 msec, repetition
frequency of 1 Hz, and carrier frequency of 125 Hz. The duration
of the rst phase of the impulse is variable (15 min)
over 1 years
COLD Zone 1: 10 Hz (10 min)
Zone 2: «7720» (10 min) any age

18
POTENCY
Zone 1: 2,6 Hz (5 min) + 4,0 Hz (5 min) + 9,4 Hz (5 min)
Zone 2: «7710» (15 min)
Zone 3: 10 Hz (5 min) + 20 Hz (5 min)
over 13
years
KIDNEYS Zone 1: 77 Hz (10 min) + 20 Hz (10 min)
Zone 2: 2,8 Hz (5 min) + 8,1 Hz (5 min) + «7710» (5 min) over 7 years
BACK Zone 1: 140 Hz (5 min) + 77 Hz (5 min) + 20 Hz (5 min) over 4 years
JOINTS Zone 1: 140 Hz (5 min) + 77 Hz (5 min) + 20 Hz (5 min) + 1,6 Hz (5 min)
Zone 2: «7710» (10 min) over 7 years
NAUSEA Zone 1: «7710» (10 min) over 4 years
TRAUMA Zone 1: 200 Hz (5 min) + 140 Hz (5 min) + 77 Hz (5 min) over 1 years
ASPHYXIA Zone 1: «7710» (10 min)
Zone 2: 1,0 Hz (3 min) + 8,0 Hz (3 min) + 3,6 Hz (3 min) any age

193.4 Maximum consumption current (with supply voltage of 3 V) is not more than 300 mA.
3.5 Power supply source: batteries of LR6/АА type, 2 pieces with voltage of 1.5 V. It is allowed
to use the relevant storage batteries with voltage of 1.2 V*.
3.6 The device weighs not more than 0.35 kg.
3.7 The overall dimensions of the device are not more than 165
х
65
х
65 mm.
3.8 The device automatically switches o not later than 5 minutes after one of its keys
(except for key) has last been pressed, after the electrodes have been released from skin,
or after the stimulation period has nished.
Operation procedure (recharger types, recharge methods) is described in the storage battery instruction
manual. Duration of the device service when used with storage batteries depends on characteristics of the
batteries.
*

20 3.9 Electromagnetic Radiation
Test Conformity to IEC 60601-1-2 Conditions of Use
Radio-
frequency
radiation
CISPR 11
Class B DENAS-PCM Electrical Stimulator can be used in all
types of institutions and at home as well
Group 1
DENAS-PCM emits very little radio-frequency
radiation that cannot lead to failure of electronic
equipment located nearby
3.10 Resistance to radio-frequency radiation.
Теst IEC 60601-1-2 test conditions Acceptable level
IEC 61000-4-6 3 Vrms от 150 kHz до 80 МHz 3 Vrms
IEC 61000-4-3 3 V/m от 80 МHz до 2,5 GHz 3 V/m