RC ART Osteo-DENS User manual

LLC RC ART
Ekaterinburg, Russia
Transcutaneous Electrostimulator
Operations Manual
Osteo DENS
RC ART 08.0-03.71-01 RE
Россия/
Russia
ЕС, все
страны/
EU, all
США/
USA
Канада/
Canada
LLC „RC ART“
Ekaterinburg, Russland
Elektrostimulator
GEBRAUCHSANWEISUNG
Osteo DENS
RC ART 08.0-03.71-01 RE

2
CONTENTS
Part 1. Technical Passport
1. Safety...............................................................................................6
2. Intended use................................................................................9
3. Specications.............................................................................10
4. Complete Set.............................................................................15
5. Design of the Device..............................................................16
6. Operation Mode.......................................................................20
7. Technical Maintenance.........................................................23
8. Change of power source......................................................24
9. Troubleshooting.......................................................................25
10. Warranty Conditions...........................................................27
Part 2. User’s Instructions
1. Main Performance Data.......................................................30
2. Function......................................................................................32
3. Indications and Contraindications to Application.......33
4. Conditions of Treatment......................................................34
5. Intensity of the Electrostimulating Treatment............35
6. Recommendations for Application...................................37
Coupon for Warranty Repair..............................................81
Certicate of Acceptance....................................................83

3
This Operations Manual is intended for the Osteo-
DENS electrostimulator with built-in electrodes for
stimulation of reex zones on the posterior surface
of the human neck.
The Operations Manual includes the Technical
Passport (part 1) and User’s Instructions (part 2).

4

5
PART 1
Technical passport

6
1. SAFETY
All information in this operations manual
contains important information about your
safety and recommendations on proper
use and maintenance of the device.
The device does not constitute any danger because
of internal low voltage power source isolated from
the body of the apparatus (article of type B and body
of type F).
The apparatus must not be used for treatment of pa-
tients with implanted electronic devices (for exam-
ple, pacemaker) and for treatment of patients who
have individual electric current intolerance.
Use of the device in direct front projection of the
heart is prohibited.
Don’t switch the patient to any high-frequency elec-
tric device during stimulation. Simultaneous use of
the device and other electric equipment can result in
burns and possible damage of the device.
Work near short-wave and microwave equipment
can result in instability of output parameters of the
device.

7
Avoid long-term exposure of the device to direct
sunlight at high (>25°) air temperature. This can re-
sult in malfunction of the device indicator or dam-
age of the power elements.
The device has fragile elements. Keep it safe from
blows.
The device is not waterproof. Keep it safe from wa-
ter penetration.
All repair works on the device must be provided by
qualied specialists at the manufacturer.
Transportation conditions: temperature -50°С to
+50°С, relative air humidity 30 to 93%, atmospheric
pressure 70 to 106 kPа.
Storage conditions: temperature -50°С to +40°С,
relative air humidity 30 to 93%, atmospheric pres-
sure 70 to 106 kPа.
Operation conditions: temperature +10°С to
+35°С, relative air humidity 30 to 93%, atmospheric
pressure 70 to 106 kPа.

8
Attention! In case of storing the device at temperature below 10°С,
keep it under normal conditions minimum two hours
before use.
Recycling: All packaging materials are environmen-
tal-friendly and can be recycled.
Individual assembly of electrical and electronic
equipment.
The device contains valuable materials that may be
used again after recycling considering the require-
ments for environment preservation. Deliver it to
special service centers (consult with appropriate
services of your region) for collection and recycling.

9
2. INTENDED USE
The Osteo-DENS device is intended for electrostimula-
tion of reex zones on the posterior surface of the hu-
man neck. The device has built-in electrodes.
The Osteo-DENS apparatus is intended for individual
application in patient-care institutions and in life con-
ditions in compliance with the recommendations of
the attending doctor.

10
3. SPECIFICATIONS
3.1. Electric impulse parameters under nominal power
voltage have the following output parameters:
3.1.1. Under minimum signal power with load of 2 kOhm
the duration of the positive impulse is 25 ± 10 uS.
Amplitude of the positive impulse is maximum 30 V.
Amplitude of the negative impulse is maximum 30 V.
3.1.2. Under maximal signal power with load of 20
kOhm the duration of the positive impulse 250 ± 70 uS
Amplitude of the positive impulse is 30 ± 10 V.
Amplitude of the negative impulse with load (20 ± 1
kOhm) – 150 ± 70 V.
3.1.3. Amplitude of treatment at the minimum power
level is ≈ 50 % of the amplitude at the maximum power
level (R = 20 kOhm).
3.2. Dependence of the impulse shape on the load re-
sistance at the medium and maximum power
Table 1
Load
resis-
tance
Power level 7 units Power level 15 units
Shape of the
output signal Vp-p
Shape of the
output signal Vp-p
No
load
≈ 140 V
± 20%
≈ 140 V
± 20%

11
200
Ohm
≈ 9 V
± 20%
≈ 10 V
± 20%
500
Ohm
≈ 24 V
± 20%
le ≈
16 mA
Epulse ≈
42 mcJ
≈ 28 V
± 20%
le ≈ 8
mA
Epulse ≈
78 mcJ
1
kOhm
≈ 42 V
± 20%
≈ 54 V
± 20%
2
kOhm
≈ 60 V
± 20%
≈ 84 V
± 20%
10
kOhm
≈ 140 V
± 20%
≈ 140 V
± 20%

12
20
kOhm
≈ 140 V
± 20%
≈ 140 V
± 20%
Notes: curves in phase A of mode 1 at the point of maximum power.
3.3. The apparatus provides for selection and setting of
two electrostimulation modes.
3.4. Maximum consumable current (with 3 V voltage)
in the device is maximum 140 mA.
3.5. Power source: 2 batteries type LR6/AA, total volt-
age 3.0 ± 0.6 V.
It is allowed to use accumulators of the similar type,
size and voltage*.
3.6. Weight of the main parts of the electrostimulator:
— control unit, maximum 80 gr.
— block of neck electrodes, maximum 170 gr.
3.7. Dimensions of the main parts of the electrostimu-
lator:
— control unit, maximum 130x50x22 mm;
— block of neck electrodes, maximum 120x60x40 mm.
order of operation (types of chargers, charging methods) is
provided in the manual for accumulators. Period of apparatus
operation with accumulators depends on the accumulators’
specications.
*

13
3.8. The device will automatically switch o not later
than in 2 minutes after the last pressing of the appara-
tus buttons (except for On/O button) or last applica-
tion of the electrodes to the patient’s skin surface.
3.9. Electromagnetic Radiation
Table 2
Test Compliance Application Conditions
HF
radiation
CISPR 11
Class B
Osteo-DENS is suitable for use
in all establishments including
home application.
3.10. HF Resistance
Table 3
Test IEC 60601-1-2 test
conditions Permissible level
IEC 61000-4-6 3 Vrms
150 kHz to 80 MHz 3 Vrms
IEC 61000-4-3 3 V/m
80 MHz to 2.5 GHz 3V/m
3.11. Resistance to Electromagnetic Fields
Table 4
Test Test
Level
Level of
Compliance Application Conditions
Electrostatic
Discharge
(ESD)
IEC 61000-
4-2
±6kV
contact
±8kV
in.
±4kV con-
tact ±8kV
in.
Floors to be wooden,
concrete or ceramic tile.
If oors are covered with
synthetic material, rela-
tive air humidity to be
minimum 40%.

14
Magnetic
elds
IEC 61000-
4-8
3A/m 3A/m
Magnetic elds param-
eters to be typical, for
business buildings and
medical and prophylactic
institutions.
3.12. Recommendations on determining the required
distance between the Osteo-DENS electrostimulator
and radio equipment
Table 5
Stated maxi-
mum output
power of the
transmitter
R (W)
Radiation Frequency of the Transmitter and
Equation to Determine the Distance d (m)
150 kHz to 80
MHz d = 1.2√P
150 kHz to 800
MHz d = 1.2√P
800 MHz to 2.5
GHz d = 2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

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4. COMPLETE SET
The complete set of delivery of the Osteo-DENS device
should correspond to Table 6.
Table 6
Name of the device, part, document Quantity
Control unit 1
Block of neck electrodes 1
Operations Manual 1
Case 1
Power source (AA type) 2

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5. DESIGN OF THE DEVICE
5.1. General Information
The Osteo-DENS apparatus consists of the block of neck
electrodes and the control unit connected with the ca-
ble. The power sources to be placed into the compart-
ment of the block of neck electrodes.
5.2. Block of neck electrodes
The block of neck electrodes (Fig. 1) is to be xed on
123
Fig. 1. Appearance of the Block of Neck Electrodes
1. Body
2. Built-in Electrodes
3. Cover of the battery compartment

17
Attention!
the posterior surface of the patient’s neck with the help
of a soft elastic bracing. Electrostimulation of the reex
zones on the posterior surface of the human neck is
conducted directly from the block of neck electrodes.
Before the treatment procedure with the apparatus it
is recommended to take o current-conducting deco-
rations (metallic chains and so on).
It is strictly forbidden to connect to the block of neck
electrodes any devices except for the control unit
in the complete set of the Osteo-DENS apparatus.
Connection of an inappropriate device can result in
malfunction of this device or in damage of neck elec-
trodes and be dangerous for the user. Breakdown of
neck electrodes resulting from connection of inappro-
priate devices shall not be a warranty event!
Allergic reactions are possible due to individual intol-
erance of the materials used in the apparatus. In case
of allergic reactions you should stop the procedure
and address an expert.
Attention!
Attention!

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5.3. Control Unit
The control unit (Fig. 2) provides control of modes and
power of electrostimulation in the block of neck elec-
trodes via the connection cable.
1. Body
2. Display – liquid crystal indicator
3. Keyboard
4. Connection cable
Fig. 2. Appearance
of the control unit
The control unit can be connected to the block of neck
electrodes in the complete set of the Osteo-DENS ap-
paratus. Connection of the control unit to an inappro-
priate device can result in malfunction of this device
or in damage of the control unit. Breakdown of the
control unit resulting from connection of inappropri-
ate devices shall not be a warranty event!
Attention!

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5.3.1. Control Buttons on the keyboard
Table 7
Control Buttons*
Switch on/o
of the appara-
tus
Switching
between elec-
trostimulation
modes
Reduction
of the treat-
ment power
Increase of
the treatment
power
5.3.2. Indicator of the Control Unit
When pressing any of the keyboard buttons, the indicator ashes.
*
1. Digital indicator and scale of duration of the
therapeutic signal inuence
2. Digital indicator and
scale of power of the ther-
apeutic signal inuence
3. Indicators of electrodes
contact with the skin sur-
face
4. Indicators of the opera-
tion modes
5. Battery indicator

20
6. OPERATION MODE
6.1. Preparing the apparatus for operation
Open the cover of the battery compartment on the
block of neck electrodes (BNE). Place the batteries as
per item 8 of this Technical Passport. Close the battery
compartment.
Connect the BNE and control unit (CU) with the cable.
Fix the BNE on your posterior neck surface yourself or
ask for help, electrodes should t on the skin but the
bracing shall not be too tight. For better contact the
skin in the area to be treated can be wiped with a tam-
pon wetted with water or apply some Malavtilin cream
(the procedure may be started after full absorption of
the cream).
6.2. Switching the apparatus on
Shortly press the button on the control unit, you will
hear the sound signal with introduction and the indica-
tor will show the following information:
power level“01”
scale of treatment
power
symbol of the treat-
ment mode
symbol of a battery
total time of the proce-
dure“15”
scale of treatment
time
when the electrodes
contact the skin –con-
ditional images of 2
zones of treatment on
the posterior neck sur-
face are displayed