JPA DiaDENS-T User manual

64
DiaDENS-T Pro-2010
OPERATIONS
Contact: JPA
[email protected]
www.jpastar.com
[phone]
FOR INFORMATIONMORE
MANUAL

RC ART LLC, Ekaterinburg, Russia
Operating Manual
DiaDENS T
RC ART 09.1-03.72-04 RE
Россия/
Russia
ЕС, все
страны/
EU, all
США/
USA
Канада/
Canada

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TABLE OF CONTENTS
Part 1. Technical Passport
1. Safety rules..............................................................70
2. Intetnded purpose..............................................75
3. Unit description....................................................76
4. Application instruction......................................80
5. Package contents.................................................89
6. Maintenance and battery
replacement procedure.....................................90
7. Troubleshooting...................................................93
8. Technical information.........................................97
9. Manufacturer`s guarantees...........................104
10. Manufacturer`s address................................106
Part 2. Application Instruction
1. General information..........................................108
2. Indications and contraindications...............109
3. Treatment conditions.....................................113
4. Electrostimulation intensity..........................115
5. Stimulation methods......................................117
6. Indication of modes.........................................118
7. Recomendation on selection
of treatment areas.............................................125
Annex 1. Brief reference atlas on the
application of DENS for treatment
of common diseases..............................................191
Annex 2. Accessories used....................................211
Warranty Maintenance Form..............................217
Acceptance certicate............................................220

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Thank you for using the DiaDENS-T unit.
In order to make the usage of the unit eective and safe, please read carefully all
section of this manual.

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PART 1
Technical Passport

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1. SAFETY RULES
Please read carefully all information marked with this sign. This information is
important for ensuring safety and eective use of the unit.
The information contained in this Operating Manual is important for
your safety and for correct application and maintenance of the unit.
The unit is safe in operation as it uses the low voltage power supply isolated
from the working part of the unit (type B device with a type F working part).
The unit may not be used to treat patients with implanted electronic devices
(such as the heart pacemaker) and to treat patients with idiosyncrasy to electric
current.

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The unit may not be used in the area of direct anterior projection of the heart.
During stimulation the patient should not be connected to any high frequency
electric device. Simultaneous use of the unit and other electric devices may
cause burns and possible damage of the unit.
Operation in the vicinity of short-wave or microwave equipment may cause
the output parameters of the unit to become unstable.
Only the detachable electrodes manufactured by the supplier may be
connected to the unit.

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The product contains fragile components. Please avoid shocks.
Avoid long-term exposure of the unit to direct sunrays at a high ambient
temperature (over 25 oC). This may cause failure of the indicator on the unit
or destroy its batteries.
The unit is not waterproof. Protect is from moisture.
All maintenance works on the unit must be performed by skilled technicians
at the manufacturing factory.

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Transportation conditions: temperature -50 to +50 0С, relative air humidity 30
to 93 %, atmospheric pressure 70 to 106 kPa (525 to 795 mm Hg).
Storage conditions: temperature -50 to +40 0С, relative air humidity 30 to 93
%, atmospheric pressure 70 to 106 kPa (525 to 795 mm Hg).
Operating conditions: temperature +10 to +35 0С, relative air humidity 30 to
93 %, atmospheric pressure 70 to 106 kPa (525 to 795 mm Hg).
Warning! If the unit was stored at the ambient temperature lower than 10 0С,
before operating keep it under normal climatic conditions for at least two hours.

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Recycling: the unit packaging materials are not hazardous for the environment;
they can be recycled.
Separate collection of electric and electronic equipment.
Warning! The unit contains precious materials that may be used repeatedly
after disposal with consideration of the environmental protection regulations.
They must be submitted to specially designated collection and recycling facilities
(please consult in the relevant services in your locality).

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2. INTENDED PURPOSE
The DiaDENS-T unit is used for electrostimulation in a broad range of frequencies with
selectable individual treatment programs.
The DiaDENS-T unit is designed for medical and preventive treatment facilities and
individual application in accordance with the instructions of the attending physician.
Compliance:
This medical device bears the CE marking in compliance with Directive 93/42/EEC
concerning Medical Devices.

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3. UNIT DESCRIPTION
Picture 1. Arrangement of the unit. Front
keyboard
case
display

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Picture 2. Arrangement
of the unit. Back
battery compartment cover
integrated electrodes
label* loudspeaker
*
connector** for
detachable electrode
The unit contains a duplicate label with the serial number under the batteries (inside the battery compartment) of
the unit. Make sure not to remove it and not to delete the serial number as it results in loss of warranty for the unit.
** Warning! The connectorisonly designed for connectionofelectrodesmanufacturedbythe supplier.Never connect
the unit to the computer as is may cause failure of the computer and expose the user to the risk of electrocution.

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Stimulation power
step-up
Stimulation power
step-down ON/OFF
timer control operation mode change

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Picture 4. Designation of symbols on the unit display
Stimulation power
(digital indication
Stimulation power
(graphic indication)
Time or measurement
results indication
Stimulation frequency
setting
Screening mode
Test phase indication, MED
mode
Battery charge indication
Sound level
Timer activation
Therapy mode
MED mode
Contact with the skin detected

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4. APPLICATION INSTRUCTIONS
4.1. Procedure conditions
No special conditions are required for the procedure. The room should be dry and
warm. During the procedure the patient should be positioned comfortably, seated or
lying. After the procedure it is recommended to remain relaxed for 10–15 minutes.
4.2. Switching on the unit
Press the button; the unit should turn on and switch to the standby mode.
4.3. Mode selection
To select the desired mode, use the Mode and Mode buttons.
The modes in the menu of the unit are located in the following sequence: Screening →

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MED →20 Hz →60 Hz →77 Hz →140 Hz →200 Hz. When the unit is switched on, the
default mode setting is 77 Hz.
4.4. Stimulation power setting
In order to set the desired power, use the Power and Power buttons:
— each time the button is pressed, the power is decreased or increased by one unit;
— for continuous increase or decrease of the stimulation power press and hold down
the button. When the desired power level is reached, release the button.
The stimulation power level setting is shown in the left top corner of the display as
a number symbol and on the linear horizontal scale. If the detachable electrode is
connected, the power is reset to 0.
4.5. Timer
If you need to set a xed stimulation time, use theTimer function intended for operation
in the 200 Hz, 140 Hz, 77 Hz, 60 Hz and 20 Hz modes and is activated by pressing the
button.

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By default the Timer function is switched o; in this case the maximum procedure
duration is 30 minutes.
Each time you press the button, the stimulation time is set at 5, 10, 15 and 20
minutes and the Timer Activated indication ( ) is shown on the display.
Next pressure of the button (after a 20-minute interval) switches o the Timer function;
the Timer Activated indication on the display disappears.
4.6. Volume setting
The unit can operate in a mute mode or you can select one of the two sound alarm
volume settings. The volume level is set using a combination of the , Power
and Power buttons.

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To select the sound alarm volume, press a combination of and Power buttons
simultaneously to increase the volume or press the combination of and Power
buttons simultaneously if you want to decreases the volume or switch o the sound.
The volume level is indicated on the display of the unit: no picture; ; .
4.7. Forced Therapy Function
In the Forced Therapy mode, the unit can operate in the therapy modes irrespective
of the presence and the quality of the contact of the electrodes with the skin surface.
The mode is primarily used when detachable electrodes are connected, when it is not
always possible to control the quality of the contact.
To activate the Forced Therapy function, press simultaneously the Power and
buttons; the mode is deactivated by simultaneously pressing the Power and