INFERUM ABP-051 User manual

Operation manual
Electrostimulator «ABP-051»
HYPERTENSION
HYPOTENSION

English
In order for the device to be effective and safe, please carefully
read all the sections of this instruction.
Thank you for purchasing our Electrostimulator «АВР-051» for arterial
blood pressure correction.
Instruction for use is an integral part of this product which is
must-know before the actual use of the device.

CONTENTS
1. Purpose ........................................................................................................ 4
2. Operating principle of the electrostimulator .................................. 4
3. Indications for use of Electrostimulator «ABP-051» ..................... 6
4. Possible adverse effects when using .................................................. 6
5. Contraindications for use of the electrostimulator ....................... 6
6. The electrostimulator design description ........................................ 7
7. Precautions for use of the electrostimulator ................................. 10
8. Indication of the opportunity and peculiarities of the
electrostimulator use for people with implantable medical
devices, pregnant women, nursing mothers, children, adults with
chronic diseases ......................................................................................... 14
9.Information on the possible effect of the electrostimulator use
on the abilities to drive and use machines ........................................... 14
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10. Indication of the necessity of the electrostimulator storage
out of the reach of children ..................................................................... 14
11. Recommendations for Electrostimulator «ABP-051» use ...... 15
12. Conditions and procedure of working with Electrostimulator
«ABP-051» ..................................................................................................... 16
13. Technical characteristics ................................................................... 19
14. Medical device package contents ................................................. 25
15. Maintenance and repair requirements ........................................ 25
16. Service life .............................................................................................. 28
17. Transportation and storage ............................................................. 29
18. Disposal and removal ....................................................................... 30
19. Manufacturer's warranty .................................................................. 31
20. Manufacturer's address..................................................................... 32
Warranty sheet............................................................................................ 33
Acceptance mark ....................................................................................... 34
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1. Purpose
Electrostimulator «АВР-051» was designed for therapeutic
noninvasive (without disturbance of the skin) course treatment of wrist
zones by transcutaneous electrical stimulation with the aim of arterial
blood pressure (ABP) correction only in combination with drug therapy.
Treatment course contributes to:
• arterial blood pressure correction;
• improvement of overall well-being;
• improvement of emotional state;
• increase of efficiency;
• reduction of meteorological dependence;
• improvement of patient’s quality of life.
The electrostimulator was designed for use in treatment and
preventive institutions and at home.
Area of intended use – physiotherapy.
2. Operating principle of the electrostimulator
Stimulation with electric current is the best way to activate receptor
structures and to start the work of regulatory and adaptive mechanisms
of the organism. It is easy to select the electric current amplitude,
regulate impulse frequency, length, form, and polarity. Electric current is
an adequate activator of excitable tissues.
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Electrostimulator «АВР-051» exercises effect, first of all, on vascular
tone. It is the most effective and safe way to correct blood pressure. In
this case, the device has practically no effect on cardiac output volume
or heart rate.
The choice of zones was determined by the type of disorder and
usability of device at work, at home, during the course of treatment.
Stimulation is effected with a group of impulses. The number of
groups corresponds with the frequencies. The treatment efficiency
depends on the patient’s state before the device usage.
Adaptation to electrostimulation develops less frequently and more
slowly, in addition, treatment with Electrostimulator «АВР-051» has
small intensity and duration; thus, portability and procedures safety
increase.
Electrostimulator is a mobile, light-weight and compact device that
allows you to carry out procedures at any convenient time, anywhere, as
well as:
• acts without subcutaneous introduction, has no risk of infection;
• is painless;
• period of zones treating depends on the selected mode;
• system is designed to be used with one hand in order to facilitate the
operation;
• no hospitalization required for the course of procedures.
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3. Indications for use of Electrostimulator «АВР-051»
• Persistently high arterial blood pressure in patients with essential
hypertension – as an additional treatment to comprehensive drug
treatment.
• Episodic arterial blood pressure increase under stress situations,
weather changes, etc. in patients with labile arterial hypertension.
• Low blood pressure in patients with hypotension – as an additional
treatment to comprehensive drug treatment.
Attention! The device is indicated for use by persons over
age 14.
The electrostimulator should be used strictly for the purpose
intended.
4. Possible adverse effects when using
No possible adverse effects when using of electrostimulator were
identified.
5. Contraindications for use of the electrostimulator
• implanted pacemaker;
• atrial fibrillation;
• individual intolerance to electric current;
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• skin lesion in the left wrist zone;
• neoplasms (tumors) of any origin and localization;
• acute febrile conditions of unclear origin;
• acute psychic excitement, alcohol or drug abuse.
6. The electrostimulator design description
6.1. Physical configuration of Electrostimulator «АВР-051» is shown
in Fig. 1a and Fig. 1b.
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1 - Button On/Off for
Program No. 1 (has three
raised points on the surface)
2 - LED for Program No. 1
3 - Front panel
4 - Battery case cover
5 - LED for Program No. 2
6 - Button On/Off for
Program No. 2 (has one
raised point on the surface)
7 - Cuff
1
2
3
4
5
6
7
Fig.1а. Design and physical configuration (top).

6.2. The device includes two automatic programs for the course
treatment of wrist zones of the skin integument with various
frequencies of the electric current.
Program No. 1:
• Zone on the inner left wrist is treated to decrease arterial pressure
(Fig.2). Program No. 1 is started by pressing the button with three raised
points and is accompanied by white LED flashing at the top of the device
front panel.
Program No. 2:
• Zone on the outer left wrist is treated for arterial pressure increase
(Fig. 3). Program No. 2 is started by pressing a button with one raised
8 - Housing
9 - Electrodes
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Fig.1b. Design and physical configuration (bottom).

point and accompanied by white LED flashing at the bottom of the
device front panel.
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Fig. 2. Zone for patients with high arterial pressure.
Fig. 3. Zone for patients with low arterial pressure.

After the end of any program you will hear an audio signal, the LED
will stop blinking, and the electrostimulator will automatically turn off.
7. Precautions for use of the electrostimulator
7.1. Examine the packaging and the electrostimulator before using it.
Do not use electrostimulator if it is damaged.
7.2. The way of use of the electrostimulator should fully correspond to
its intended purpose.
7.3. The product labeling and supporting documentation contains
the symbols and information relating to the safety of the
electrostimulator:
7.3.1. Technical requirements ТУ 9444-005-12342964-2015 is a
normative document determining requirements to the product and
applicable in the territory of the Russian Federation and the CIS
countries.
7.3.2. РУ No. РЗН 2016/3776 dated March 31, 2016 is the registration
certificate for a medical device issued by the Federal Service for
Surveillance in the Russian Federation.
7.3.3. This medical device is approved by the notified body IMQ
S.p.A. for the CE marking according to the Directive 93/42/EEC as
amended the Directive 2007/47/EC concerning medical devices.
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0051

7.3.4. The electrostimulator has passed the procedure of
mandatory certification and corresponds to the national
standards of the Russian Federation.
7.3.5. Attention! Read all safety information carefully!
7.3.6. Carefully read all the information about your safety in this
Operation manual, as well as recommendations on the proper
use and care of the electrostimulator.
7.3.7. The device poses no hazard for users due to internal low
voltage source isolated from the working part of the device (BF
type product).
7.3.8. During stimulation the patient should not be connected to any
high-frequency electrical device. Simultaneous use of the
electrostimulator and other electrical equipment can lead to burns and
possible damage of device.
7.3.9. Using near short-wave or microwave equipment may cause
instability of electrostimulator output parameters.
7.3.10. The device shouldn’t be used in patients with implanted
electronic devices (for example, a pacemaker) and in patients with
individual intolerance to electric current.
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7.3.11. The device should be operated by a person who is awake and
adequately evaluates environmental factors. Use of device by persons
with borderline conditions or in inadequate mental states is not
allowed.
7.3.12. In case of any allergic reaction as a result of device contact
with skin, you should immediately stop using the electrostimulator and
consult a specialist.
7.3.13. All repair operations of the product should be carried out by
qualified specialists at the manufacturer plant.
7.3.14. No changes in design made by user are allowed.
7.3.15. The product contains brittle details. Protect from impacts.
7.3.16. The product is not waterproof. Keep away from moisture.
7.3.17. Keep the electrostimulator away from heating units;
avoid prolonged exposure to direct sunlight at high (more than
+35°C) air temperature. Do not expose the product to heat
treatment.
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7.3.18. Operating conditions: temperature from +10°С to +35°C,
relative humidity from 30 to 93%, atmospheric pressure from 70
to 106 kPa.
Attention! If the device was stored at ambient temperature
below +10°C, keep it at room temperature in closed packaging
for at least 3 hours before use in order to avoid condensation.
7.3.19. For information relating to the manufacturer, see section
20 of this Operation manual.
7.3.20. For information relating to the official representative in
the EU countries, see section 20 of this application data sheet.
7.3.21. For disposal information, see section 18 of this Operation
manual.
7.3.22. Serial number and date of manufacture are indicated
under the battery cover.
+10
+35
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8. Indication of the opportunity and peculiarities of electro-
stimulator use for people with implantable medical devices,
pregnant women, nursing mothers, children, adults with chronic
diseases
The use of device is not permissible:
• with an implanted pacemaker;
• for children under 14 years.
The use of device is possible:
• during pregnancy and lactation;
• with existing chronic diseases, if they are not included in p. 5.
9. Information on the possible effect of electrostimulator use on
the abilities to drive and use machines
There were no studies of the possible effect on the abilities to drive
and use machines because the electrostimulator and its accessories do
not belong to products that may affect the psychomotor state and are
not used during driving and using machines.
10. Indication of the necessity of electrоstimulator storage out of
the reach of children
Keep out of the reach of children.
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11. Recommendations for Electrostimulator «АВР-051» use
11.1. Course of procedures
The procedures should be carried out 1-3 times a day for 14 days,
preferably at the same time, regardless of the blood pressure level
before the procedure. Patients with hypertonic disease need refresher
regular courses of treatment at least once a month (for example, from 1st
to 14th of each month).
Action has the cumulative effect, that is, blood pressure becomes
stable at the end of the treatment course.
11.2. In cases of situational (and repeating) increase or decrease of
arterial pressure, treatment course of at least 14 days is required, 1-3
procedures per day. At the beginning of treatment temporary arterial
pressure destabilization can be observed, then followed by a steady
decrease under hypertension or a steady increase under hypo-
tension.
11.3. Under labile arterial hypertension (i.e. rare periodic and
insignificant arterial pressure increase (no more than 150 mm Hg))
Electrostimulator «АВР-051» can be used as a monotherapy. This
approach slows down and prevents the development of disease to a
stable form.
11.4. Recommendations on the use of Electrostimulator «АВР-051» in
patients over the age of 70: milder rate of blood pressure decrease is
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required. For this purpose, treatment with Electrostimulator «АВР-051» is
recommended once a day. Treatment course should be not more than 7-8
days. After 10-15 days of break, it is reasonable to repeat treatment cour-
se. During the first course of treatment, blood pressure may vary slightly.
11.5. Recommendations on the use of Electrostimulator «АВР-051»
in patients with hypertension (persistently high blood pressure (above
180 mm Hg)) who are taking medications: the duration of course and the
number of procedures per day should be determined after consultation
with the attending physician.
Attention! During treatment with Electrostimulator «АВР-051»
the self-withdrawal of medications is NOT permitted. After
receiving of persistent antihypertensive effect, the regimens
and doses of medication can be changed only by attending
physician!
12. Conditions and procedure of working with Electrostimulator
«АВР-051»
12.1. Unpack the device, remove packaging material. Check the
integrity of device and its accessories by visual inspection.
12.2. Carrying out the procedures with the electrostimulator by the
patient himself at home or by medical staff in treatment and prevention
institutions does not require special training and special skills.
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12.3. During the session the patient can sit or lie in a comfortable
position.
Attention! You shouldn’t use the device being in the upright
position!
12.4. Remove watch or bracelets from the left wrist, free it from
clothes elements.
12.5. Select zone (see p. 6.2).
12.6. Treat the electrodes of the electrostimulator and skin of action
zone with wet wipe or with cotton ball slightly moistened with water.
12.7. Put the electrostimulator on your left arm depending on the
action zone, as shown at figures below.
12.7.1. Treatment zone for patients with high arterial pressure (Fig. 4).
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Fig. 4.
HYPERTENSION
HYPOTENSION

12.7.2 . Treatment zone for patients with low arterial pressure (Fig. 5).
Fig. 5.
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12.8. Tighten the cuff of the electrostimulator and fix it with no free
space between cuff and wrist. Electrodes of the electrostimulator should
tightly touch the skin, without overtightening the wrist.
12.9. Turn on the electrostimulator by pressing the button (Pos. 1 Fig.
1a) in case of high pressure, or a button (Pos. 6 Fig. 1a) in case of low
pressure. The corresponding LED will light up (Pos. 2 or Pos. 5 Fig. 1a).
12.10. At the end of treatment session, an audio signal will sound, and
the device will turn off automatically. The LED will turn off.
For forced shutdown of the electrostimulator, press and hold the
On/Off button (Pos. 1 or Pos. 6 Fig. 1a depending on the action program)
for more than 1 s. Audio signal will sound, and the device will turn off. The
LED will turn off.
HYPERTENSION
HYPOTENSION

12.11. Remove Electrostimulator «АВР-051». It is recommended to
rest for 20-30 minutes after session.
Attention! After each procedure the electrodes of the
electrostimulator should be wiped (see p. 15.1.2.)! The lack of
proper cleaning can lead to allergic reactions or skin infection in
case of using by several patients. The electrostimulator should be
stored with dry electrodes!
13. Technical characteristics
13.1. Basic technical characteristics are shown in Table 1.
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Supply voltage, V 3±0,6
Table 1
Input current, not more than, mА 200
ValueCharacteristic name
Electrostimulator weight (with cuff and inter-
nal electrodes (without batteries), not more
than, kg
Measures (without cuff), not more than, mm 75 х 75 х 40
0,1
Power supply Galvanic batteries
of ААА type (R03), 2 pcs.