JPA DENS-APPLICATOR User manual

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Remote zonal electrode
DENS-APPLICATOR
OPERATION INSTRUCTIONS
TABLE OF CONTENTS
Part 1. Technical passport.
1. Function
2. Technical characteristics
3. Complete assembly
4. Safety rules
5. Technical maintenance
6. Warranties
7. Transportation and storage
8. Utilisation
Part 2. Operation Instructions
1. General considerations
2. Treatment conditions
3. Conducting DENS-session with DENS-APPLICATOR
4. Recommended action zones

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PART 1
TECHNICAL PASSPORT
1. FUNCTION
The remote zonal electrode DENS-APPLICATOR is intended for prophylactic and
therapeutic noninvasive treatment of biologically active zones.
It is intended for home and clinical use.
The remote zonal electrode will be used only together with electrostimulators of the
DENAS or DiaDENS series.
2. TECHNICAL CHARACTERISTICS
2.1. Characteristics of the zonal electrode # 1:
— mass, kg, not exceed ing .................................................0.1
— overall dimensions, mm, not exceeding ............................. 120х120
— number of metal electrodes, items 9
2.2. Characteristics of the zonal electrode # 2:
— mass, kg, not exceed ing .................................................0.1
— overall dimensions, mm, not exceeding .............................2200х60
— number of metal electrodes, items ...................................7
2.3. Diameter of the metal electrode, mm, not exceeding 15
2.4. Length of cable of the electrode, mm, not exceeding 700
2.5. Total weight of the assembly, kg, not exceeding..............0.4
3. COMPLETE ASSEMBLY
The complete assembly in accordance to Table 1.
Таble 1
Name Number,
items
The remote zonal electrode # 1 1
The remote zonal electrode # 2 1
Belt 1
Wide cuff 1
Narrow cuff 2
Operation Instructions combined with
passport and instruction for application 1
Packaging 1

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2. SAFETY RULES
Please read carefully the information contained in this Operation Instructions! It
contains important guidelines for your safety, as well as correct use and main-
tenance of the device.
The device must not be used for treatment and diagnosis of the patients with implanted
electronic devices (for instance, cardiostimulator) or patients with individual
intolerance of electric current.
During stimulation, the patient must not be connected to any high-frequency
electrical device.
Attention! You must not connect the electrode to any other devices except for the
DENAS series or DiaDENS devices.
Attention! Do not simultaneously connect two and more electrodes to the device.
Attention! Do not bend the remote zonal electrodes # 1
and # 2 at the angle lesser than 90°.
5. TECHNICAL MAINTENANCE
Daily technical maintenance must consist of the following:
—visual inspection of the device;
—disinfection (for cleaning the electrode, use standard disinfectants and soft
cleaning tissues);
—checking electrode function will be performed by connecting it to DENAS or
DiaDENS series devices.
6. MANUFACTURER WARRANTY
6.1. The manufacturer guarantees that the device complies with requirements of
Technological Conditions (TC) provided that the operation, transportation and storage
conditions are observed.
6.2. Device service life: 5 years.
When operated properly, the service life can be considerably longer than that above
mentioned standard.
6.3. The device limited warranty: 24 months from the date of sale.
6.4. Complete assembly and appearance of the item will be checked upon receipt of the
product in presence of retailer.
After sale, no claims on complete assembly or appearance will be accepted.
6.5. If there is a defect found in the device during the warranty period, the retailer
(manufacturer) warrants to satisfy consumer's demands as stipulated by the RF Law
"On protection of consumer's rights."
Retailer (manufacturer) or a company acting as a retailer (manufacturer) based on
the contract with the former is not liable for defects if they should occur after the
delivery of the device to the user as a consequence of:
1) breaking the rules of transportation, storage, maintenance and operation by the
user, as these rules are indicated in this Operation Instructions;
2) actions by third parties;
3) force major circumstances.
6.6.In the event of the device failure or defect found during the warranty period or in

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discovering incomplete assembly, the owner must send an application for repair
(substitution) to the manufacturer, indicating surname, name, patronymic, address,
telephone, brief description of the defect, date and conditions of its occurrence.
7. STORAGE AND TRANSPORTATION
Transportation conditions: at temperature from -50°Сto +50°С, relative air humidity
up to 98% at the temperature +25°С.
Storage conditions: at temperature from -50°Сto +40°С, relative air humidity up to
98% at the temperature +25°С.
2. UTILISATION
All packing materials are environmentally safe can be reused.
All materials used for the device are recyclable.

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PART 2
OPERATION INSTRUCTIONS
1. GENERAL CONSIDERATIONS
DENS-APPLICATOR will be used for treating areas of skin inaccessible for treatment by
the patient him- or herself or when there is no time with available for applying built in
electrode.
The dynamic electroneurostimulation (DENS) through the remote zonal electrode will
be used for treating pain syndromes associated with diseases of muscularskeletal (2x)
system of inflammatory, degenerative or traumatic origin, and for relieving headaches.
The DENS, through the remote electrode will be used for relieving muscle tension, for
prophylaxis of functional disorders of the muscular-skeletal system associated with pro-
longed fixed body positions during work (including working on a computer), training,
flights, car trips, or when physical exercises are not feasible.
Reliable fixation of the electrode on the body will provide convenience and comfort
during the therapy session: the patient can seat in comfortable position and apply DENS
independently.
Attention! The first and often the only sign of a serious disease might involve a
sudden sharp pain of any localization. Therefore if the pain occurred for the first time
and reoccurs, consult your physician immediately.
See contraindications in respective sections of Operation Instructions for DENS-
therapy devices (the devices of DENAS and DiaDENS series).
2. THE TREATMENT CONDITIONS
No special conditions are required for operating DENS. During the DENS-APPLICATOR
session, the patient must be seated or lying down. The metal electrodes must be in per-
manent contact with patient's skin during the procedure.
3. CONDUCTING DENS-SESSION WITH DENS-APPLICATOR
To follow hygienic requirements, it is recommended to treat the metal electrode
surfaces before each procedure, the electrodes will be treated with a standard
disinfecting solution (e.g. 70% rubbing alcohol) applied with soft cleaning tissues.
Attention! You must not connect the electrode to any other devices except for DENAS
or DiaDENS series devices.
Attention! Before using the remote electrode, in order to reinforce the DENS effect,
the skin in the action area may be treated with small amount of Malavtilin ointment
until completely absorbed.
When working with the remote zonal electrode it is necessary:
1) To fix the remote zonal electrode on the belt or cuff (see Figures 1,2):

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2) To fix the remote zonal electrode in the direct projection of a problem area: for back
pain - at the area of the maximal discomfort; for joint pain - at the respective joint. The
DENS can be applied to segmental problem zones (p. 4.2). The electrode must be firmly
fixed upon the skin; do not shift the electrode during session.
Figure 3. Fixation of the remote zonal electrode # 1 on the body with the aid of belt in
the paravertebral (spine) area in the small of the back.
The cuffs will be used for fixation of electrodes on extremities (Fig. 4, 5, 6, 7).

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3) To connect the electrode to the dynamic electroneurostimulation device:
—the electrode will be connected to the "DENAS" device through stand;
—to the DENAS+ device - through the adapter;
—to the devices of the "DiaDENS" series - directly.
4) To switch the device on, pushing the "On" key.
5) To switch on the THERAPY regime at the frequency 77 Hz (for the DENAS and
DENAS+ devices) or at the frequencies 20, 60, 77, 140 or 200 Hz (for the DiaDENS
series devices) and select the necessary range of energy action (see the principle of
selection of the frequency and intensity of the action in the Operation Instructions for
respective device).
Attention! The remote therapeutic electrode must only be used in the THERAPY
regime.
Conducting the session.
The duration of procedure in the THERAPY regime, in the zone of direct projection of
problem area and metamer-segmental zones, should not exceed 60 minutes per session
and will depend on the patient's responses as follows:
—the complaint has been completely eliminated;
—the patient feels considerable improvement.
To relieve muscle tension due to prolonged fixed body positions, the DENS will be
applied for 10-15 minutes. The action can be repeated with 1-1.5-hour intervals.
7) Having completed the session, push the "Off" key, disconnect the electrode from
the device, take off the straps, and treat electrodes with disinfecting solution (e.g. 70%
rubbing alcohol).
Attention! Keep the electrodes dry.
4. THE RECOMMENDED ZONES OF ACTION
4.1.Local problem area (the zone of direct projection of the problem area)
One of the simplest and effective ways of applying DENS involves acting directly on
the area of detailed and localised pain. The zone will be treated in the THERAPY regime
until clinical effect is achieved. For instance, for lumbalgia, on the small of the back
zone; in knee joint damage, directly upon the damaged joint area.
4.2.Metamer-segmental zones
The location and distribution of the spinal nerve roots, nerves, nervous plexuses and
of the vegetative nervous system nodes are subject to the law of metamerism. The same
spinal segments will serve, at that, as the innervation device and, respectively, the
device transferring information from an internal organ and a certain skin area
(dermatomer) and back. The existing recommendations (see Table 1 below) make it
possible to apply DENS within the spinal projection and paravertebral (near the spine)
zones as well as in areas of a certain dermatomer, e.g. in headache - back of the neck
area (see Figure 8 below).

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Таble 1. The dermatomers recommended for treatment using the DENS-APPLICATOR
Conventional designations:
С- dermatomers of the spinal cord cervical segments D - dermatomers of the spinal
cord thoracic segments L - dermatomers of the spinal cord lumbar segments S -
dermatomers of the spinal cord sacral segments
Skin der-
matomers Symptoms
C3, C4,
D2
— headache, dizziness; — tension of the occipital muscles, pain in the
back of the head, torticollis, pain in the shoulders, back, small of the
back, sensation of the spine tension, muscle spasms in the neck and back
(contraction), tension of occipital muscles, pain in the scapular area, pain
in th
e
kn
ee,
pa
in in th
e
jo
int
s
D2,D3
— pain and tension of muscles in the areas of the back, small of the back,
shoulder, occiput, torticollis, intercostals neuralgia; — reduced or absent
sensitivity of the shoulder and elbow area
D3,D4
movement disorders in the neck area, tension of the occipital muscles,
pain in the shoulder external surface, that of scapula, in the chest, in the
small of the back area, in abdomen, pain in the sacrum and in the back
D4, D5 — headache; — diseases of the neck, pain in the scapula, in the area of
shoulder and back
D5, D6
— headache, dizziness; — tension of the back and spine muscles, pain in
the back and in the chest, intercos-tals neuralgia, pain in the spine and
spasm of the back muscles (contractions)
D6, D7
pain in the back and in the neck, limited mobility of the spine,
contractionsofthecontractionsofthe of the back muscles, intercostals
neuralgia
D7, D8 pain in the small of the back and in the back, intercostals neuralgia,
paravertebral muscle contraction (muscle spasm along the spine)
D9,D10 — pain in the small of the back and in the back, sensation of "unrest" in
the spine area; — pain in the chest and in the hypochon-drium
D10.D11 pain in the abdomen, small of the in the back and in the back,
contractions and limitation of the spine mobility, intercostals neuralgia
D11.D12 pain in the back
D12.L1 pain in the back and in the spine

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L1.L2
— pain and contractionsinthelumbarcontractionsinthelumbar in the lumbar
area, muscle tension in the spine and small of the back, oedemas in the
lower extremities; — damage to the lower extremity joints; — pain and
tension in the small of the back and in the back, sensation of tension in
the spine muscles, pain in the hip, lumbalgia
S2, S3, S4
— pain in the sacrum, small of the back, spine, sensation of weakness in
the knee joint, pain in the joints; — pain in abdomen, sacrum and hip
joint, lumbago
S3,S4 pain in the small of the back, sciatica, pain in the spine
S4, S5
pain in the small of the back, in the back, sacral-coccygeal area, pain in
the area of lateral surface of the buttock, lumbalgia, sciatica, tension of
the spine muscles, weakness of the leg muscles
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