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INFERUM ABP-051 Operation Manual

Electrostimulator for arterial blood pressure correction.
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Operation manual
HYPERTENSION
Electrostimulator «ABP-051»
HYPOTENSION

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Summary of Contents for INFERUM ABP-051

  • Page 1 Operation manual HYPERTENSION Electrostimulator «ABP-051» HYPOTENSION...
  • Page 2 English Thank you for purchasing our Electrostimulator «АВР-051» for arterial blood pressure correction. In order for the device to be effective and safe, please carefully read all the sections of this instruction. Instruction for use is an integral part of this product which is must-know before the actual use of the device.
  • Page 3 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.
  • Page 4 English 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.

  • Page 5: Purpose

    English 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: •...
  • Page 6 English 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.

  • Page 7: Possible Adverse Effects When Using

    English 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. •...

  • Page 8: The Electrostimulator Design Description

    English • 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.
  • Page 9 English 8 - Housing 9 - Electrodes Fig.1b. Design and physical configuration (bottom). 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: •...
  • Page 10 English point and accompanied by white LED flashing at the bottom of the device front panel. Fig. 2. Zone for patients with high arterial pressure. Fig. 3. Zone for patients with low arterial pressure.

  • Page 11: Precautions For Use Of The Electrostimulator

    English 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.
  • Page 12 English 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.
  • Page 13 English 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.
  • Page 14 English 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.

  • Page 15: Chronic Diseases

    English 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: •...
  • Page 16 English 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).

  • Page 17: Abp-051

    English 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.
  • Page 18 English 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.
  • Page 19 English 12.7.2 . Treatment zone for patients with low arterial pressure (Fig. 5). HYPERTENSION HYPOTENSION Fig. 5. 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.

  • Page 20: Technical Characteristics

    English 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.
  • Page 21 English Table 1 (ctd.) Characteristic name Value IP 41 is a degree of protection against pene- tration of external solid objects (protection Body protection from particles > 1.0 mm) and protection against drops of water falling vertically. Class of protection against BF type electric shock of working parts 13.2.
  • Page 22 English 1st phase 2nd phase 30±10V Maximum 95±25V Fig. 6. Impulse from and parameters. Treatment zone diameter: 10 mm. Operating frequencies of the program are 9.2 Hz and 77 Hz. Total action time of the program is 5 minutes. Indication: white LED blinking (Pos. 2 Fig. 1a), audio signal after the end of program.
  • Page 23 English Treatment zone: see Fig. 3. Treatment zone diameter: 10 mm. Operating frequencies of the program are 77 Hz and 140 Hz with amplitude modulation at a frequency of 4 Hz. Total action time of the program is 6 minutes. Indication: white LED blinking (Pos.
  • Page 24 English 13.5. Resistance to electromagnetic fields Test Correspondence Test Use conditions level level The floor should be wooden, concrete or of ceramic tiles. Electrostatic ±6kV ±4kV contact If the floor is covered with discharge (ESD) contact ±8 V air synthetic materials, the rela- IEC 61000-4-2 tive humidity of air should ±8 V air...
  • Page 25 English equipment is required, the electrostimulator and other equipment should be checked for correct operation in the conditions (operation modes) in which it will be used. 13.8. Electromagnetic conditions. The electrostimulator was designed to work under certain conditions of electromagnetic environment. 13.8.1.

  • Page 26: Medical Device Package Contents

    English 14. Medical device package contents Amount, pcs. Name Electrostimulator «АВР-051» with internal electrodes and cuff Operation manual Informative guide Inner package Attention! Batteries don’t come standard with the device! For this device please use LR03 / AAA or R03 / AAA batteries. 15.
  • Page 27 English 15.1.3. Checking of the electrostimulator functionality in accordance with Section 12. 15.1.4. The product is designed for repeated use. In the case of malfunction, repair should be carried out by the manufacturer. 15.2. Power elements replacement: When the symbol is blinking on the screen or when the electrostimulator does not turn on (completely discharged batteries), you need to replace the power elements.
  • Page 28 English Fig.7. Fig.8. 15.3. Possible malfunctions and the ways of their handling. Table 2 shows the states of electrostimulator that can be fixed by yourself. In case of other faults please contact the manufacturer’s representative. Do not try to handle them by yourself!

  • Page 29: Service Life

    English Table 2 Fault Way of handling Device turns off / Batteries are discharged – you should replace doesn’t turn on the batteries. Device doesn’t turn You should remove the batteries, keep the device on after batteries for 2 minutes without them, then place them back replacement as it is shown at Fig.

  • Page 30: Transportation And Storage

    English 17. Transportation and storage 17.1. Transportation conditions: 17.1.1. Products are transported by all types of transport in roofed vehicles. Conditions for devices transportation – temperature from -50°C to +50°C, relative air humidity from 30% to 93%, atmospheric pressure from 70 kPa to 106 kPa. 17.1.2.

  • Page 31: Disposal And Removal

    English 18. Disposal and removal 18.1. To be disposed of as household waste. 18.2. All packaging materials do not have toxic effect on the environment, they can be reused. 18.3. Separate collection of electrical garbage: An old device contains valuable materials that can be reused after recycling according to the requirements of environmental protection.

  • Page 32: Manufacturer's Warranty

    English 19. Manufacturer's warranty 19.1. Warranty period is 24 months from the date of sale. 19.2. Seller (manufacturer) or organization which on the basis of the contract performs seller (manufacturer) functions is not responsible for the defects, if they appear after device transfer to the consumer and emerge due to: •...

  • Page 33: Manufacturer's Address

    English 20. Manufacturer’s address Inferum LLC 620026, Russia, Ekaterinburg, Belinskogo Str., 86-487 Postal address: 620100, Russia, Ekaterinburg, Sibirsky Tract, 12, b. 1, of. 206 Tel./fax: +7 (343) 247-84-51 E-mail: info@inferumgroup.com www.inferumgroup.com CARLAINE s.r.o. Rybářská 839/2 360 17, Karlovy Vary, Česká republika...

  • Page 34: Warranty Sheet

    English Warranty sheet «АВР-051» Name: Electrostimulator Model ____________________________________________________________ Product number ____________________________________________________ Production date _____________________________________________________ Date of purchase ____________________________________________________ Owner __________________________________________________________ Address ___________________________________________________________ Phone number ______________________________________________________ Date of asking for repair _______________________________________________ Reason for being repaired _____________________________________________ Repair mark _______________________________________________________ Signature of organization officer who is in charge for acceptance after repair The product is examined, no claims against package contents or physical configuration.

  • Page 35: Acceptance Mark

    English Acceptance mark «АВР-051» Electrostimulator is considered usable Serial number Date of production Acceptance mark Seller’s signature ___________________________________________________ Date of sale ________________________________________________________ Warranty conditions are accepted, the product is examined, no claims against package contents or physical configuration. Buyer’s signature ___________________________________________________ Date of purchase ___________________________________________________ Attention!!! Carefully examine the device upon purchase! Defects of housing (scratches, cracks, chips) do not belong to warranty events.
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  • Page 38 0051 INFE 05.01-03.72-03ИП...

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