Diadens diaDENS-CARDIO User manual

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EN
CONTENTS
1. Function..................................................................40
2. Complete Set and Apparatus Arrangement................47
3. Order of Treatment...................................................50
4. Technical Maintenance.............................................53
5. Order of Replacing the Power Source......................54
6. Troubleshooting List................................................55
7. Specifications.........................................................57
8. Safety Measures....................................................65
9. Guarantees of the Manufacturer............................69
10. Special EMC-information......................................72
Certificate of Acceptance...........................................75
Coupon for Warranty Repair.......................................77

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EN
1. FUNCTION
The DiaDENS-CARDIO apparatus is intended for thera-
peutic non-invasive (without damaging the skin surface)
course treatment of biologically active zones of the wrist
by the method of dynamic electrostimulation for correction
of the arterial blood pressure (AP) and normalization of the
general state of health. The apparatus is intended for peo-
ple of over 14 years of age with a labile form of the arterial
hypertension and patients with a lasting increase of the ar-
terial blood pressure (essential hypertension) as an addi-
tional treatment on the background of drugs taken.
The DiaDENS-CARDIO apparatus combines frequency
9.2 Hz which is traditionally applied for treatment of hyper-
tension and a specially developed mode “77 10” intended
for producing a general sedative effect.
Electrostimulation with the “DiaDENS-CARDIO” appara-
tus promotes normalization of the vessel wall, dilatation of
capillaries, and improvement of hemodynamics in the sys-
tem of cutaneous microcirculation.

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EN
As a result of these:
— arterial pressure is being stabilized at the level accept-
able for a patient;
— cenesthesia improves;
— psycho-emotional state improves;
— physical efficiency increases;
— the risk of complications of the essential hypertension
is reduced;
— quality of the patient’s life improves.
The DiaDENS-CARDIO apparatus is intended for
course treatment of patients with arterial hypertension
as an additional treatment on the background of basic
drug therapy.
Even in cases of situational (single, seldom) increase of
the arterial blood pressure a course treatment of not less
than 10 procedures is necessary, 1-2 procedures daily.
Meanwhile, in the beginning of treatment a temporary
destabilization of the arterial blood pressure with its further
stable reduction may be observed.

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EN
Apparatus treatment has an effect of “accumulation” that
is AP becomes stable by the end of the treatment course.
Application:
DENS procedure is to be carried out 1-2 times daily, bet-
ter in one and the same time of the day regardless of the AP
level before the procedure.
Patients with essential hypertension need repeated reg-
ular treatment courses minimum once a month (for instance
from the first to the 15th day of each month).
Attention! There is no need to control AP after the pro-
cedure.
In compliance with international recommendations, it is
recommended for patients with essential hypertension to
keep a “journal of AP” and measure arterial blood pressure
three time a day at one time (morning, afternoon, evening),
even if the patient feels good. In case of any complaints
(headache, vertigo, pain in the heart, intermission in the

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heart work, weakness, syncopal state and others) an addi-
tional measurement of AP is needed.
It is strongly FORBIDDEN that the patient with a consider-
able increase of AP and high risk of vascular complications
(myocardial infarction, cerebral stroke, thromboembolism)
stops taking the drugs him/herself on the background of
treatment with the “DiaDENS-CARDIO” apparatus. After
having a stable hypotensive effect registered in the “jour-
nal of AP”, regimes and doses of drug treatment may be
changed by the attending doctor.
Patients with seldom periodical and slight increase of the
arterial blood pressure (not higher than 150 mmHg) – labile
arterial hypertension – can apply the “DiaDENS-CARDIO”
apparatus as monotherapy. Such an approach can retard
and prevent the disease from converting into a stable form.
Indications for Application:
— stable high arterial blood pressure of patients with essen-
tial hypertension – as an addition to complex drug treatment;

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— episodic increase of AP under stressful situations,
changes of weather conditions and so on in patients with a
labile form of arterial hypertension.
Recommendations for application of the “DiaDENS-
CARDIO” apparatus for course treatment: carry out 1-2
procedures a day during 10-15 days regardless of the AP
indices before the procedure. With a stable form of arterial
hypertension, repeat the courses monthly.
Recommendations for one-time application of the
“DiaDENS-CARDIO” apparatus for persons with sus-
ceptibility to AP increase under ill-being: take a hypo-
tensive medicine recommended by your attending doctor
and additionally carry out treatment procedures with the
“DiaDENS-CARDIO” apparatus every 1-1.5 hours until the
complaint is eliminated. In case of long-lasting high arterial
blood pressure, address the doctor.

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EN
Recommendations for application of the “DiaDENS-
CARDIO” apparatus for patients older than 70 years
of age: in the advanced age a slower rate of AP reduction.
For this a recommended order of treatment with the “Dia-
DENS-CARDIO” is once a day. Treatment course – not more
than 7-8 procedures. It is advisable to repeat the treatment
course after 10-15 days break.
During first treatment course, AP can fluctuate a little
that’s why the patient shall continue taking the hypotensive
medicines prescribed by the doctor.
Recommendations for application of the “DiaDENS-
CARDIO” apparatus for patients with malignant hy-
pertension: malignant hypertension is a stable high arte-
rial blood pressure, more than 180 mmHg that cannot be
treated with drug correction under correct adequate and
systematic taking of drugs.
Course duration and number of procedures per day shall
be determined after consulting an attending doctor.

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Contraindications to Application:
Absolute:
— individual intolerance to the electric current;
— implanted cardiostimulator;
Relative — in these cases it is recommended to use the
electrostimulator only after consulting your attending doc-
tor:
— epileptic seizure;
— neoplasms of any etiology and localization;
— acute febrility of unclear etiology;
— vein thrombosis
— condition of acute psychic excitement, alcoholic or
drug intoxication;
Attention! On the background of application of the “Dia-
DENS-CARDIO” apparatus taking the drugs prescribed by
the doctor is obligatory! Changing the regimes of medical
treatment and reduction of doses of the drug to be taken
is allowed after stable reduction of AP and after consulting
your attending doctor only.

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2. COMPLETE SET AND APPARATUS ARRANGEMENT
Apparatus body
Display
Cover of the power
source compartment
ON/OFF button
Cuff
CaseBatteries LR6/AA,
1.5 V type
Operations Manual

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EN
Symbols of the display:
Contact with skin surface (stable)
/ End of the procedure (blinking)
Replace the power source
(blinking – the batteries
are partly discharged /
stable – replace the pow-
er source urgently)
The apparatus is ON.

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Attention! To avoid breaking the case, fold the cuff of
the apparatus in a correct way:
Step 1. Pass the end of the cuff
through the loop.
Step 2. Fold the cuff around the
apparatus body that the lock ele-
ment of cuff be on the side of the-
cover of the power source compart-
ment
Step 3. Place the apparatus into
the case

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3. ORDER OF TREATMENT
Preparation. During the procedure, the patients can have
a comfortable sitting or lying position. After the treatment
procedure, the patient should relax for 20-30 minutes.
Attention! It is forbidden to carry out procedures with
the “DiaDENS-CARDIO” apparatus in a standing position!
1. From the left wrist take off
watches or bracelets, fold the
sleeve back. Skin should be dry
and clean.
2. Hold your hand with your
palm up, place the apparatus
on your wrist with the display up
1 cm from the wrist joint.
3. Tighten the cuff and fix it
as there is no free space between the cuff and your wrist,
the apparatus electrodes touching the skin surface but not
binding the wrist.

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4. Turn the apparatus on by
pressing the button – the ap-
paratus will turn on and produce
a sound signal and the display
will show the following symbols
and which indicate the
contact of electrodes with skin
surface and beginning of the
treatment procedure.
5. Carry out the treatment
procedure. The procedure con-
sists of three stages, which are
different in frequency, time and
amplitude of treatment. After the
end of stage, the apparatus pro-
duces a short sound signal. After
the end of the procedure the ap-
paratus produces a long sound signal and the symbol will
start blinking.

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The duration of the procedure is determined by the pro-
gramme and is approximately 5-6 minutes.
6. Take the apparatus off.
7. Turn the apparatus off by pressing the button hold-
ing it during 1-3 seconds, or with absence of contact with
skin surface the apparatus will turn off automatically after
3 minutes.
Attention! Treat the apparatus electrodes with a stand-
ard disinfection solution (for instance, alcoholic solution)
after each procedure. Keep the apparatus with dry elec-
trodes.

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4. TECHNICAL MAINTENANCE
4.1. Daily technical maintenance should include the fol-
lowing:
— external examination of the apparatus;
— disinfection of electrodes.
Use standard disinfection means and soft napless nap-
kins to clean the electrodes.
4.2. Check of service ability of the apparatus in accord-
ance with instructions in Part 3.
4.3. If the apparatus is supposed not to be used for a
long period, remove the power source from its compart-
ment (Part 5).
4.4. Having noticed the symbol on the indicator, re-
place the power source (part 5).

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5. ORDER OF REPLACING THE POWER SOURCE
When the symbol appears on the display (blinking
– power source is partly discharged, on – replace power
sources urgently) or if the apparatus does not turn on (the
power sources are discharged), you need to replace the
power sources. For this:
— open the power source compartment;
— remove the power
sources;
— let the apparatus stay
without power sources dur-
ing 2-3 minutes;
— install new power
sources*, taking into the po-
larity.
*install only that power sources which are intended for this de-
vice – type LR6/AA, rated voltage 1.5 V. When replacing the power
sources it is recommended to use power elements of the same
type and replace both elements at the same time.

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6. TROUBLESHOOTING LIST
Trouble Method of eradication
The apparatus turns off,
does not turn on or the
display shows the sign
Power sources are
discharged – replace power
sources (part 5)
The apparatus does no turn
on after replacement of
power sources
Remove power sources, let
the apparatus stay during 2
minutes without them and
install power sources again
(part 5)
The display does not
show the symbol (heart)
with contact with the skin
surface
The skin surface is dry – wipe
it with a wet tampon

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EN
The display shows the symbol
(heart) when there is no
contact with skin surface
The electrodes are dirty
– wipe the electrodes
(item 4.1)
Attention! Other troubles must be eradicated by the
manufacturer or at the service centers of the manufactur-
er.

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EN
7. SPECIFICATIONS
7.1. Dependence of Shape and impulse parameters on
load resistance
Load resist-
ance Shape Voltage
peak-peak
Free Output ≈210 V ±
20%

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200 Ohm ≈8 V ± 20%
500 Ohm ≈19 V ±
20%
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