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ProstaSmart. Manual

ProstaSmart

Urological physiotherapy system

Manual

medical physiotherapeutic device

IMPORTANT INFORMATION FOR THE PATIENT

Using the device in the presence of contraindications may have serious negative consequences for your health. Therefore, before using the device, consult with a specialist.

Please read this manual carefully. Acquaintance with the device will ensure its effective and safe operation.

To avoid damage to the control panel, rectal cartridge, and a third-party device, do not connect the control panel or a rectal cartridge with a third-party USB device.

To avoid a malfunction of the device, it is forbidden to use other network adapters.

GENERAL INFORMATION 

  1. Purpose
  2. Physiotherapeutic effects
  3. Physiological effects
  4. Clinical and laboratory effects
  5. Indications for use
  6. Contraindications for use
  7. General recommendations for use
  8. General principles of device control
  9. Contents of delivery
  10. Description of Physiotherapeutic Impact
  11. IR-therapy
  12. Hardware massage of the prostate
  13. Magnetotherapeutic effect
  14. Thermotherapy
  15. Clinical Effects
  16. The ProstaSmart Device
  17. The control panel
  18. The rectal cartridge
  19. The Order of Carryng Out The Treatment Procedure in the “PATIENT” Mode
  20. The Order of Carryng Out The Treatment Procedure in the “DOCTOR” Mode
  21. Disinfection
  22. Security Measures
  23. Operating Conditions
  24. Storage and Transportation Conditions
  25. Maintenance
  26. Manufacturers Guarantee
  27. Specifications

General Information

Purpose

The medical physiotherapeutic device “Urological physiotherapeutic system ProstaSmart (hereinafter referred to as the “device”) is created: for the prevention and treatment of exacerbations of chronic inflammatory diseases of the prostate gland (chronic prostatitis) and small organs pelvis; for the prevention and treatment of stagnant phenomena in the small pelvis; for treatment erectile dysfunction as part of complex therapy. Treatment can be carried out complexly, with application of antibacterial, anti-inflammatory drugs, alpha1-adrenoblockers, immunomodulators, adaptogens and other drugs. Carrying out physiotherapeutic procedures with the device can be used in inpatient and outpatient settings, as well as at home. The course of physiotherapy at home should be conducted according to the doctor’s prescription.

Physiotherapeutic effects

The ProstaSmart device allows simultaneous or in various combinations the following types of physiotherapy:

exposure to the prostate and pelvic organs with infrared radiation a wavelength of 940 ± 10 nm;

Hardware massage of the prostate gland;

Magnetotherapy of the prostate and pelvic organs;

Thermotherapy of the prostate and pelvic organs.

Physiological effects

improvement of microcirculation in the prostate gland and surrounding organs;

reduction of stagnant phenomena in the prostate gland;

improvement of pharmacokinetic parameters of drug means in the tissues of the prostate;

Strengthening of muscular sphincters;

anti-inflammatory effect;

stimulation of regenerative processes;

mediated improvement of erectile function;

adaptive impact.

Общий вид СП

Clinical and laboratory effects

reduction of the symptoms of the disease: a reduction in pain and dysuric manifestations;

decrease in the amount of residual urine in the bladder;

Increase in the mean and maximum rate of urination;

decrease in the number of leukocytes in the secretion of the prostate.

Indications for use

Chronic prostatitis of different etiology;

Prostateviculitis;

urethroprostatitis;

violations of the copulatory function.

Contraindications for use

Acute prostatitis;

exacerbation of chronic prostatitis during the phase of symptoms treatment;

acute inflammatory diseases of the rectum;

malignant neoplasms of the prostate;

Oncological diseases of the rectum;

active tuberculosis or suspected tuberculosis of the prostate.

General recommendations for use

It is recommended to carry out the procedure courses of 10-14 procedures each with the ProstaSmart device treatment. It is desirable to conduct procedures daily, at the same time. Minimum recommended break between courses – one month. The device can be used both in conditions of medical facility under the direct supervision of a doctor, and in the home conditions under the recommendation of a doctor. The procedure is carried out with the emptied intestines and urinary bladder.

The use of the ProstaSmart device significantly enhances the action of the medicinal products as synthetic (antibiotics), and natural (phytopreparations) of origin. Therefore, the best results can be obtained if the ProstaSmart device is applied against a background drug therapy.

 

General principles of management of the device

The device can work in two modes: “PATIENT” or “DOCTOR”. By default the device works in PATIENT mode. In this mode, it does not require any settings and performs a universal pre-established medical program that lasts 12 minutes. In the “DOCTOR” mode, it is possible to choose (depending on the nature of the pathology and treatment tactics) one of seven pre-established medical programs and set the procedure time from 7 to 15 minutes. The “DOCTOR” mode is designed for professionals and blocked by default. To unlock it you have to press a special button.

Components of the system

smartprost-shema

Control panel

AC adapter (power supply)

Rectal cartridge

 

Description of Physiotherapeutic Impatcs

Infrared therapy (IR-therapy)

Until recently, the only sources capable of generating a sufficiently powerful monochromatic electromagnetic radiation, were relatively large and expensive lasers. Recently, as alternatives to lasers they began to apply compact powerful semiconductor infrared diodes (IR diodes) in medical technology, which, like lasers, are capable of emitting electromagnetic waves in a very narrow range zone. In this case, the laser creates a narrowly directional coherent light flux which, as a rule, is necessary to disperse with the help of special attachments. IR-diodes do not have this disadvantage, because they provide scattered light through built-in microlenses.

There are three infrared diodes in the rectal cartridge of the ProstaSmart device, developed for medical use, with a wavelength of 940 ± 10 nm optical power of 350 mW each, with a scattering angle of 120 degrees. IR diodes operate in a pulsed mode with a frequency of up to 99 Hz. Pulse mode radiation provides additional stimulation of the capillaries.

Infrared radiation with a wavelength of 935-950 nm has the maximum penetrative and therapeutic effect. It has a photobiological action related to both wave and quantum effects, such as the absorption of the energy of light quanta by atoms and molecules of biological tissues (the law of Grotgus-Draper). As a result, the molecules go over into the throne-excited state (the so-called internal photoelectric effect), and electrolytic dissociation and ionization of biological molecules occur.

The energy of photons of the infrared spectrum when interacting with molecules tissues of the body enhances the vibrational processes of biological membranes and indirectly generates heat energy. Photons of infrared radiation with an energy equal to or higher than the energy of redox pairs in the chain of electron transport in the mitochondria, induce the transfer of an electron from the donor to the acceptor, i.e. activate cellular (tissue) respiration (GN Ponomarenko, II Turkovskiy, 2006). The result of photobiological Infrared light at the tissue level is an extension of the nasal vessels, increased blood flow and acceleration of reparative processes. Along with the activation of tissue metabolism, the potential for the clinical effects of infrared radiation in constant and variable low-frequency magnetic fields has been extensively studied (GN Ponomarenko, II Turkovskiy, 2006).

The energy of quanta destroys weak electrolytic bonds between ions and molecules water, thus, the magnetic field promotes dissociation and prevents the recombination of ions (photomagnetoelectric effect of Kikoin-Noskov). This significantly reduces the reflection coefficient at the tissue boundary and enhances penetrating ability of infrared light, which provides high effectiveness of the impact.

002-fon

Hardware massage of the prostate

Hardware massage with the help of the ProstaSmart device is a vibration low-frequency mechanical effect on the prostate gland. To increase the effectiveness of the massage, 32 vibratory scanners are used. Changing and alternating vibro-scribers provides the mechanical effect necessary for various phases of massage (warming up, draining, etc.) and prevents development of tolerance of competent tissues to the influencing factor. For the patient’s comfort a step-by-step adjustment of the vibration power (10 steps) is provided. Hardware massage is used as an independent physiotherapy method or as an addition to the finger massage of the prostate.

The therapeutic effect of the apparatus massage is due to the anisotropy (difference in mechanical properties) of the tissues and the associated energy absorption by the tissues of the energy of mechanical vibrations. Mechanical oscillations, like classical finger massage, cause a number of effects: improve blood circulation, reduce venous congestion, promote the restoration and maintenance of drainage function of the final sections of the prostatic acini (Ivanchenko L.P., Kozdoba A.S., Moskvin S.V. (2009), Shchetinin V.V., Zotov E.A. (2003), etc.)

Thanks to the apparatus massage of the prostate, blood circulation in the prostate becomes active, the amount of lecithin grains is secreted, local tissue resistance is increased (E.K. Arnoldi, 1999). Due to the formation of prostaglandins and other tissue mediators, and the interaction of the prostate (according to Belov scheme) with the testicles, seminal vesicles and bladder, apparatus massage of the prostate helps to increase the potency, which is explained by activation of the process of conversion of testosterone into dihydrotestosterone.

By improving the secretory activity of the gland and increasing the secretion of citrate and fructose, hardware prostate massage can lead to increased motility of spermatozoa. It is also natural to increase the orgasmic sensations, which is associated with an increase in the tone of the ejaculatory ducts and, accordingly, a more pronounced stimulation of the seminal tubercle during ejaculation.

The result of a hardware massage is also a reduction in the soreness of the prostate (both palpatory and independent) due to a decrease in the retention and volume of the gland and a smaller, in connection with this, the extension of the capsule. This also explains the relief of urination and a decrease in pollakiuria (EK Arnoldi, 1999).

DSC02914

Magnetotherapeutic effect

The rectal cartridge of the ProstaSmart device generates a constant or low-frequency variable (up to 99 Hz) magnetic field with a strength of 10 ± 3 mTs.

Magnetotherapy has analgesic, hypocoagulating, immunomodulating, adaptogenic action, as well as vasodilating action at the level of microcirculation. The positive effect of magnetic fields on biological processes in the body, including in the treatment of prostate diseases, was noted by many specialists: G.N. Ponomarenko, I.I. Turkovkiy, (2006), E.K. Arnoldi, (1999) Ivanchenko L.P., Kozdoba A.S., Moskvin S.V. (2009), etc. At present, the mechanism of the therapeutic effect of the magnetic field on the body is not fully understood. Modern research assigns a leading role in the therapeutic effect of magnetotherapy to the magnetosensitive process of recombination of free radicals in biological tissues (G.N. Ponomarenko, I.I. Turkovskiy, 2006): “The switching mechanism is due to the interaction of the intrinsic magnetic moments of electrons with nuclear spins (for example, protons) reacting molecules. It is proved that the reaction rates involving a radical pair can significantly (by tens of percent) vary in magnetic fields with induction of only 1- 50 mT. This is due to the fact that in the absence the influence of the external field, when all the spin states are isoenergetic, due to the interaction of the magnetic moments of protons and unpaired electron radicals, singlet-triplet and triplet-triplet transitions occur between the S-state and three possible T-states: T + 1; T0; T-1. The magnetic field lowers the frequency of the singlet-triplet transitions due to splitting of the degenerate triplet level into three sublevels with different energy. The main antioxidant enzymes – superoxide dismutase (SOD) and catalase are more active in the singlet state, and a decrease in the frequency of singlet-triplet transitions increases the activity of endogenous antioxidant systems of the organism, as a result of which an explanation of the mechanisms of action constant or low-frequency alternating and pulsed magnetic field through its influence on electron transitions and free radical reactions. “

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Thermotherapy

The ProstaSmart device exerts a thermal effect on the prostate through the rectal wall by heating the working surface of the rectal cartridge to 38-42 ° C in a rectum. For the comfort of the patient, a step-by-step adjustment of the heating power (10 steps) is provided.

The thermal effect causes an increase in the lumen of the resistant vessels, which leads to increased blood flow and improved microcirculation. Gain blood flow in the prostate gland leads to an increase in antimicrobial factors due to increased local production, or increased acquisition of them into the tissue from the blood, which contributes to the elimination of pathogens. Thus, the hyperthermia of the prostate can destroy a hidden, uncultivated microflora in the tissues of the gland (Schetinin V.V., Zotov S.V., 2003, Sahin et al, 1998).

Modern research notes that heating the prostate accelerates the natural resolution of inflammatory processes, explaining this by accelerating the formation of fibrous and scar structures in the focus of chronic inflammation (Kulikov A.O. (2013)). In addition, heating the prostate can disrupt the work of the afferent nerve fibers responsible for pain sensations, i.e. carry out a kind of “intraprostatic sympathectomy” (Perachino et al, 1993). The influence of temperature factors also affects the liquid crystal structure of cell membranes, the rate and direction of metabolic reactions of cells and tissues.

smartprost-main

Clinical Effects

The effectiveness of the ProstaSmart device was confirmed by a blind, placebo-controlled clinical study of the SRI UROLOGY of the Ministry of Health of the Russian Federation, in which 90 patients participated. The results of treatment of the main group of patients who received standard treatment and physiotherapy ProstaSmart, and the control group of patients receiving standard treatment and placebo (ProstaSmart device with operating displays but disabled physiotherapeutic effects) are significantly different. In the main group compared with the control group:

42% higher the maximum speed of urination;

47% less residual urine;

72% lower the number of leukocytes detected in the field of vision in the secretion of the prostate;

12% higher patient quality of life (NIH-CPPS scale);

More pronounced reduction of pain and dysuric manifestations.

The average amount of residual urine

Group

Before treatment

After treatment

Main group

35,7 ml

9,5 ml

Control group

43 ml

31,7 ml

The average value of the maximum speed of urination

Group

Before treatment

After treatment

Main group

14,7 ml/s

22,3 ml/s

Control group

14,8 ml/s

16,3 ml/s

The average value of the number of leukocytes in the secretion of the prostate (in sight)

Group

Before treatment

After treatment

Main group

7,3

1,27

Control group

7,3

6,5

The average overall score of the Life Quality and Symptom Score (NIH-CPPS)

Group

Before treatment

After treatment

Main group

25,2

9,0

Control group

25,3

12,0

According to the results of the clinical study, the ProstaSmart device is recommended for use as part of complex therapy for the treatment of patients with chronic prostatitis.

The ProstaSmart device

Общий вид СП

The device consists of a control panel, a network adapter (power supply unit) and a rectal cartridge.

The control panel

prostasmart-buttons

1. BLOCK LED indicates that the remote control is unlocked for operation in the “DOCTOR” mode *. 7. OK button. The button for starting the treatment procedure; pause during the treatment.
2. UPPER DISPLAY Countdown of the treatment procedure (timer). In the “DOCTOR” mode, it displays the number of the selected preset treatment program and the selected duration of the treatment session in minutes. 8. RIGHT SWINGING button. Adjusting the vibration power. In the “DOCTOR” mode – the choice of the duration of the treatment session.

3. MEDIUM DISPLAY During the treatment procedure – displaying the current frequency of infrared radiation and the frequency of the magnetic field.

9. INFO button. Output of information on the total number of work cycles performed by the device (medical procedures).
4. LOWER DISPLAY During the treatment procedure – displaying the installed capacity  heating and vibration power (in conventional units from 1 to 10). 10. BLOCK button. Unlocking the remote for operation in the “DOCTOR” mode *.
5. POWER button Turns the unit on and off. 11. CARTRIDGE LED Lights green if the rectal cartridge is connected to the console and is functional. Lights red if the rectal cartridge is defective.
6. LEFT SWINGING button. Adjusting the heating power. In the DOCTOR mode, a preset medical program is selected.

* The “DOCTOR” mode is intended for specialists.

prostasmart-device-draw1The POWER PLUG is designed to connect the power supply.

The USB TYPE PLUG is designed for connecting a rectal cartridge only.

Rectal cartridge scheme

prostasmart-device-draw2

The rectal cartridge consists of a casing and a connecting cable. All sources of physiotherapeutic action are located in the working area of ​​the rectal cartridge, which is covered with a transparent plastic element. An orienting rib serves to correctly insert the rectal cartridge into the rectum.

The Order of Carrying out the Treatment Procedure in the PATIENT Mode

By default the device works in PATIENT mode. In this mode, the device does not require any settings and performs a universal preset treatment program lasting 12 minutes.  To start the procedure in PATIENT mode, it is necessary to perform the following actions:

1. Plug the AC adapter into an electrical outlet, then connect the AC adapter cable to the power connector on the control panel.

2. Connect the rectal cartridge cable to the USB connector of the control panel, while the rectal cartridge will conduct a short self-test (check the operability of all its systems).

3. Put a condom on the rectal cartridge, then apply a small amount of lubricant to the condom.

dawing1

4. In the supine position on the side, the legs are bent, enter the rectal cartridge into the anus, orientating the rib towards the prostate (towards the testicles and the penis).

5. To turn on the unit, press the green “power” button on the remote control.

6. Click the “OK” button to start the universal preset  treatment program.

example1

During the procedure there is an opportunity:

1. Control the procedure countdown on the upper display.

2. Monitor the current parameters of the device on the middle and lower displays. The middle display shows the current IR frequency and the current frequency of the magnetic field (if the infrared or magnetic field is constant, the symbol “Constant” is displayed). The lower display shows the installed heating power and vibration strength in conventional units from 1 to 10. If there is no effect, the “-” symbol is displayed on the corresponding display.

example2

3. Adjust the heating power of the working surface of the rectal cartridge with the left swinging button (depending on the individual sensitivity). Heating power is displayed on the corresponding display of the console in conventional units from 1 to 10. 4. With the right swinging button, adjust the vibration power (depending on the individual sensitivity). The vibration power is displayed on the corresponding display of the console in conventional units from 1 to 10.

5. Press the “OK” button to pause, and by pressing this button again –  resume the procedure.

ATTENTION! During the procedure, if the rectal cartridge is accidentally disconnected from the control panel or the control panel from the power supply unit, the unit will return to its original state after the cable is reconnected. For the correct operation of the device, a pause of at least 3 seconds must be maintained between disconnection and connection.

After the end of the procedure

1. Turn off the device with the POWER button.

2. Remove the rectal cartridge from the anus, remove it and dispose of the condom.

3. If necessary, disconnect the rectal cartridge cable from the control panel.

4. If necessary, rinse or disinfect the rectal cartridge.

5. Disconnect the control panel from the AC adapter and remove the AC adapter from the electrical outlet.

The Order of Carrying out of the Treatment Procedure in the DOCTOR mode.

In the DOCTOR mode, it is possible to choose (depending on the nature of the pathology and tactics of treatment) one of seven preset treatment programs and set the procedure time from 7 to 15 minutes. The DOCTOR mode is for professionals and is blocked by default. To start the procedure in the DOCTOR mode, it is necessary to perform the following actions:

1. Plug the AC adapter into an electrical outlet, then connect the AC adapter cable to the power connector of the control panel (see The Order of Carryng Out The Treatment Procedure in the “PATIENT” Mode chapter.)

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2. Connect the rectal cartridge cable to the USB connector of the control panel, while the rectal cartridge will conduct a short self-test (check the operability of all its systems).

3. Put a condom on the rectal cartridge, then apply a small amount of lubricant to the condom.

4. In the supine position on the side, the legs are bent, enter the rectal cartridge into the anus, orientating the rib towards the prostate (towards the testicles and the penis, see p. 16).

5. To turn on the unit, press the green POWER button on the remote control.

6. Press the “LOCK” button to unlock the remote control for the “DOCTOR” mode. The unlocking of the remote control for operation in the “DOCTOR” mode is signaled by the “BLOCK” LED.

7. With the left swinging button, select one of the seven preset treatment programs (the number of the selected program is displayed on the left side of the upper display). Program No. 1 on the set of impacts is similar to the universal preinstalled curative program in PATIENT mode.

Preinstalled treatment programs

Programme Massage Warming IR Magnet
№ 1
№ 2
№ 3
№ 4
№ 5
№ 6
№ 7


When choosing a preset medical program, on the middle and lower displays the symbol “o” indicates the presence of appropriate physiotherapeutic effects in the selected program.

8. With the right swinging button, select the duration of the treatment session from 7 to 15 minutes (the selected duration of the treatment session is displayed on the right side of the upper display).

example3

9. Press the “OK” button to start the selected preset medical program. Next – similar to the PATIENT mode see During the procedure there is an opportunity chapter.

Disinfection

Disinfection of the external surfaces of the device is carried out as required. solution of 3% hydrogen peroxide in accordance with GOST 177 with the addition of 0.5% detergent in accordance with GOST 25644 (according to the Methodological instructions for disinfection, pre-sterilization cleaning and sterilization of medical devices MU-287-113 dated 30.12.98). The rectal cartridge is resistant to chemical sterilization according to MU-287-113 dated December 30, 1998. After disinfection, the device should be dried.

ATTENTION! Do not allow disinfectant and other liquids to enter the electrical connectors and plugs.

Security Measures

During operation, the cable of the rectal cartridge and the power supply unit must not be taut. The device should only be connected to a working electrical outlet, with the characteristics of the network specified in the technical specifications. Do not operate the device if there are cracks and chips on the adapter body, control console or rectal cartridge, and damage to electrical cables. When working with the device, anti-epidemic measures must be observed. Do not allow disinfectant and other liquids to enter the electrical connectors and plugs. Using the ProstaSmart device is allowed by medical personnel or a patient independently only after consulting a doctor.

Operating Conditions

The device is allowed to operate at an ambient temperature of +15 to + 40 ° C; relative humidity of air no more than 85%.  Shocks and other mechanical influences that can damage the body of the device or its internal components are not allowed. Antistatic safety measures must be observed.

Conditions of Storage and Transportation

The device can be stored and transported at an ambient temperature of -10 to + 40 ° C; relative humidity of air no more than 85%.  Shocks and other mechanical influences that can damage the body of the device or its internal components are not allowed. Antistatic safety measures must be observed.

Maintenance

Maintenance of the ProstaSmart device is carried out only in the service centers certified by the manufacturer. All the necessary contact information on maintenance is available on the website www.smartprost.ru.

Manufacturer’s Guarantee

Warranty period – 12 months from the date of sale. During the warranty period, the manufacturer directly repairs or replaces the device or its components if a technical malfunction occurs. The warranty is valid when the consumer observes the conditions of operation, storage and transportation of the device, as well as in the presence of a completed warranty card specifying the factory number of the product, the date of sale and printing of the trading organization. The warranty does not cover the following cases: there are signs of foreign interference in the device; there are unauthorized changes in the design; there are mechanical damages; there are damages caused by ingress of foreign objects, substances, liquids; there are damages caused by mismatch of the parameters of the power supply network; there are damages caused by static electricity.

Specifications

Hardware massage

Vibration power from 0 to 500 mW. Adjustment of vibration power occurs in 50 mW increments (10 power levels). The frequency of vibration of the rectal cartridge without additional load in the air environment from 2 to 170 Hz. 32 basic patterns of vibration.

Magnetic action

Constant or alternating low-frequency (from 1 to 99 Hz) magnetic field with magnetic induction on the surface of the rectal cartridge from 10 ± 3 mTs.

Thermal action

The maximum power of the heater is 3.3 watts. The surface temperature of the working area of ​​the rectal cartridge immersed in a liquid with a temperature of 36 to 38 ° C is from 38 to 42 ° C. There is a step-by-step adjustment of the heating power  (10 power levels). The time to reach the operating temperature regime is no more than 3 minutes.

Infrared radiation

The sources of infrared radiation are three infrared diodes with a wavelength of 940 ± 10 nm and an optical power of 350 mW each. The radiation dispersion angle is 120 degrees. The pulse repetition frequency is programmed to 99 Hz. The integrated power of radiation is regulated by the duty cycle of radiation in the range from 0 to 100%.

Power supply

The external power supply is designed for operation in AC networks with a frequency of 50 Hz and a voltage of ~ 220V (-10%, + 10%) or 230V (-10%, + 6%). Output characteristics of the power supply: voltage 12 ± 0,6 V, current up to 1,0 A. Grounding when working with the device is not required. The maximum permissible continuous operation time is 1 hour. Power consumption is not more than 20 W.

Other Features

The mass of the power supply is not more than 170 g. The weight of the control panel is no more than 500 g. The mass of the rectal cartridge with a cable no more than 270 g. The cases of the control panel and the rectal cartridge are made of ABS plastic. On the potential risk of use the device refers to medical products of class 2a in accordance with GOST R 51609.

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