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High Technology Medical Devices 1 | Sreznevského 17, 831 03 Bratislava, Slovakia Tel: +421 2 446 409 77; Mobile: +421 948 610 228, +421 903 114 944; Mail: [email protected]; Web: www.onkocet.eu


INSTRUCTIONS FOR USE (USER’S GUIDE) GENERAL GUIDELINES

This Operating manual, including specifications, is a User’s manual for the PLASON Air‐Plasma Scalpel‐Coagulator‐

Stimulator

Read this User’s manual before using the PLASON Air‐Plasma Scalpel‐Coagulator‐Stimulator

The present User’s manual contains the description of device, operating principle, technical characteristics and operating

instructions for the PLASON Air‐Plasma Scalpel‐Coagulator‐Stimulator

Safety Signs

‐ Refer to user manual/booklet

‐ General safety sign

‐ General prohibiting sign

‐ General warning sign


1. GENERAL INDICATIONS

1.1. As the basis of the action of the Air‐plasma scalpel‐coagulator‐stimulator “PLASON” (further as “device”) is assumed the action of the flow of air plasma containing the molecules of the mono‐oxide of nitrogen on the tissue of the human organism, for therapeutic effect. 1.2. The User´s Guide is intended for the medical staff that operates the device, and engineering personnel, that conducts the maintenance and repair of the device.

1.3. Device is a restorable article and in the case of malfunction can undergo routine repair. 1.4. Only medical staff that has studied this user´s guide and received training of the device use, can operate the device. 1.5. The use of the device during the application of combustible anesthetics is inadmissible. 2. DESIGNATION

2.1. Device is intended for coagulation and sterilization of wound surfaces, evaporation and destruction of nonviable cloths and pathologic formations, dissection of biological tissues by plasma flow with the temperature up to 4000 °C, and also for the stimulation of reparative processes during the treatment of wounds, trophic ulcers, bedsores, sharp and chronic inflammatory processes, scar and sclerous changes, other defeats of the external covers of soft tissues, mucous membranes and internal organs by gas flow with the temperature up to 40°C, which contains the mono‐oxide of nitrogen (NO), in the conditions of surgical departments.

3. TECHNICAL SPECIFICATIONS

3.1. The overall dimensions of device correspond to the values, indicated in the Figure 2. 3.2. The mass of device with the equipment does not exceed 7.5 kg. The electric power supply of device is achieved from the electric network with alternating current with a voltage of 220‐230 V with a frequency of 50 Hz 3.4. The power, consumed by device, does not exceed 500 V∙A. 3.5. Device works with interchangeable manipulators, which ensure the regimes of coagulation, destruction and therapeutic action (NOx‐therapy). 3.6. The overall dimensions of manipulators correspond to those indicated in Table 1. Таble 1

MANIPULATOR LENGTH Mm

DIAMETER mm

DIAMETER OF OUTLET mm

MARKING

Coagulator 130±2 14±0.1 4.0+0.05 dark‐blue

Coagulator 130±2 14±0.1 1.2+0.05 red

Destructor 130±2 14±0.1 0.7+0.05 yellow

Stimulator‐Coagulator 130±2 14±0.1 1.8+0.05 green


A B C D

Fig. 1.1: Various types of manipulators: A ‐ blue coagulator, B ‐ red coagulator, C ‐ green stimulator, D – yellow destructor

Fig. 1.2: Various types of manipulators


Fig. 2: Dimensions of PLASON device


3.7. Nominal operating current of the manipulator 2.30 A ± 0.23 A.

3.8. Time of the start of manipulator operation after pressing the “START” button is not more than 5s.

3.9. The device ensures work for 4 hours in the intermittent service. Time of operation ‐ 5 min., pause ‐ 1 min.

3.10. Upon the switching of the “on/off” switch from “0” to “I” the “on/off” switch and the “STOP” button is illuminated.

In this setting the desired flow rate of air (MIN, NORM, MAX) can be selected by pressing one of respective control

buttons, which correspond to the selected flow rate.

3.11. On the safety the device corresponds to requirements GOST R IEC 60601‐1‐2010 (IEC 60601‐1:2005‐12) class I with

the working part of the type B.

3.12. The device is resistant to the mechanical actions by operation acc. to GOST R IEC 60601‐1‐2010 (national standard)

for group 2.

3.13. The device by the operation is resistant to the action of climatic factors by GOST R 15150‐69 (national standard)

for the the climatic performance UKhL of category 4.2

3.14. The device in the packing of manufacturing concern is resistant to the climatic actions during the transportation

and the storage by GOST 15150‐69 (national standard) for the conditions for storage nr. 5.

3.15. The device in the transport packing is resistant to the mechanical actions with the transportation and possesses

vibration strength and shockproof quality by GOST R IEC 60601‐1‐2010 (national standard) for group 2.

3.16. The external surfaces of device and manipulators are resistant to disinfection in accordance with the requirements

of MU‐287‐113 (national standard)

3.17. The device on the possible consequences of failure relates to the class B by GOST R IEC 60601‐1‐2010 (national

standard).

3.18. Mean operating time of device to the failure ‐ is not less than 1000 hours.

3.19. Average working life to the writing off of device ‐ is not less than 5 years. The criterion of limiting condition is

impossibility or the economic inexpediency of the restoration of device.

3.20. The time required for changing of the manipulator is not more than 3 minutes.

3.21. The electrical installation of device corresponds to requirements RDT 25.106‐88 (national standard).

3.22. The device corresponds to requirements of electromagnetic compatibility IEC 60601‐1:2005‐12.

3.23. Metallic and nonmetallic mineral coatings correspond to GOST 9.303‐84 (national standard) for the group of

operating conditions 1 GOST 15150‐69 (national standard).

3.24. Paint and varnish coats ‐ GOST 9.032‐74 (national standard) for the operating conditions correspond to UKhL 4

GOST 9.104‐79 (national standard). Coatings of external surfaces ‐ not lower than the III class by GOST 9.032‐74 (national

standard).

3.25. The level of the acoustic power at a distance of 1.0 m of the outline of device does not exceed 65 dBA.

3.26. The temperature of the external parts of the device, which do not have contact with the patient, accessible for

touch when in normal operation, does not exceed 55ºC.

3.27. Class of device concerning the potential risk of application ‐ 2a by Annex IX of the Directive 93/42/EEC.


4. DELIVERY SET

4.1. The delivery set of device corresponds to the indications in table 2. Таble 2

№

Designation Designation of the document Quantity, pieces

1. 2. 3. 4. 5. 6. 7. 8. 9.

10.

11.

12.

Air‐plasma scalpel‐coagulator‐stimulator “PLASON”

Set of the equipment Coagulator Destructor Generator‐ stimulator Distancer Gas‐tube Cold nitric oxide tip 130 mm Key

Pedal Transporting bag

Operational documentation

Passport Description of medical technology on CD

КРЛД 38642.001.

КРЛД 38642.001.07.

КРЛД 38642.001.08.

КРЛД 38642.001.09.

КРЛД 38642.001.11.

КРЛД 38642.001.12.

КРЛД 38642.001.14.

КРЛД 38642.001.15.

КРЛД 38642.001.16 .

КРЛД 38642.001 ПС

1 2 1 2 1 1 1 1 1 1 1 1

5. DEVICE, OPERATING PRINCIPLE AND THE REGIMES OF WORK

5.1. Construction of device. The device consists of the service block (SB), electro‐hydro pneumatic (EHP) supply, interchangeable manipulators, silicone tube with a metallic tip and footswitch. SB is structurally executed in a rectangular metal housing, which consists of two parts ‐ lower and upper. The lower part of the housing consists of horizontal base, front and rear panels and serves for the installation of all systems, which ensure the work of manipulator. Front panel includes: ‐ illuminating “ON/OFF” switch; ‐ button “START” and “STOP” with illumination for starting and turning off the manipulator; ‐ button “MIN”, “NORM”, “MAX” with illumination for the control of the air flow rate; ‐ the hinged connection of the EHP supply; ‐ thread carbine for the connection of silicone tube with a metallic tip; ‐ jack opening for the connection of the footswitch (pedal). Two brackets for the coil of electric cable are located on the rear panel, where also a special key for changing of the manipulators is fixed. The upper part of the housing is the removable cover of SB, on its top two containers with threaded


caps are located at both ends, used for storage of manipulators. The central container also serves as a handle for transporting of the device. On the upper panel there is also the tube for inserting of the manipulators for the built‐in cooler of air‐plasma flow, closed with threaded cap with inscription “GAS COOLER”, and also the filler neck of reservoir of the cooling liquid, closed with threaded cap with inscription “COOLING LIQUID” 1.3 m long EHP supply is attached to the front panel of SB and is executed in the form of plastic bellows, on end of which the connection joint for manipulators is located. Inside the bellows there are flexible tubes, intended for supply and outlet of the manipulator cooling liquid, supply of working gas ‐ atmospheric air to the manipulator and electric power supply wires of the manipulator. The threaded carbine located on the front panel is used for connecting of the 1.3 m long silicone tube with the detachable metallic tip for the output of the cooled NOx‐ containing gas flow (NO ‐CGF). 5.2. Description of device and modes of its operation. Service block contains all the systems ensuring the work of the device: the supply of atmospheric air, cooling, electric power supply, automation, control and sound communication. The basic element of device is the medical manipulator, connected to the service block with the flexible electro‐hydropneumatic (EHP) supply tube. Manipulator is fixed on EHP supply by an adapter nut and can be easily changed for a new manipulator of the same type or a manipulator with other functionality. The device is supplied with the manipulators of three types ‐ coagulator, destructor and generator – stimulator. The manipulators of all three types are the generators of the air plasma flow, made according to the linear three‐electrode diagram and which differ from each other in terms of the construction of outlet. Coagulator (dark‐blue, red marking) has outlet channel with a diameter of 1.2 (blue) and 4.0 (red) mm. The work of coagulator with any selected air flow rate it is formed the vividly luminous plasma flow with the outlet temperature from the channel of 3000‐4000°C and small gas‐dynamic pressure. Destructor (yellow marking) has outlet channel with a diameter of 0.7 mm. The destructor forms more localized plasma stream (compared to the coagulator) with the temperature of 2500‐3000 °C and an increased gas‐dynamic pressure. Generator‐ stimulator (green marking) has outlet channel with a diameter of 1.8 mm. The generator‐ stimulator by any selected air flow rate forms a weakly luminous plasma flow with the outlet temperature of 700‐800°C and a small gas‐dynamic pressure. All manipulators are not only the sources of air plasma, but also sources of the nitric oxide NO, which is formed in the air plasma as a result of the plasma‐chemical reactions. Available regimes of the work of device are determined by the characteristics of gas flow, which escapes from the manipulator, basic parameters of which are its temperature and content of the nitric oxide in it. For the scalpel regime of action on the cloth the determining parameter is the gas flow temperature, values of which on its axis for different types of manipulators are represented on Fig. 3. For the therapeutic action (NOx‐therapy) the content of the nitric oxide is the determining parameter of gas flow. The nature of a change in the NO gas flow content on its axis is represented in Fig. 3. Depending on the arrangement of manipulators, fixed on the EHP supply tube, device allows to realize two groups of the operation modes (Fig. 4). The first group of regimes ‐ regimes with the free expiration from the manipulators of air‐ plasma flow, in this case device is in state A on Fig. 4, and manipulator is kept in the hand of user. The second group of regimes are the regimes of action on the biological tissue by the cooled (room temperature) NO‐ containing gas flow. To achieve this, any manipulator needs to be put into the tube of the built‐in cooler. The supply of


NO‐CGF to the biological tissues is achieved through the silicone tube with the metallic tip with a diameter of the outlet of 0.7 mm fixed at its end (state of device B in Fig. 4). For checking of the correct functioning the device is equipped with a system of sound communication. It starts the first sound signal during the establishment of the work regime and shorter sound signals after every 60 seconds of the manipulator work. For maintaining the stable thermal condition of manipulators the device is supplied with a closed liquid system, which ensures their effective cooling and rejection of the heat into the surrounding space through two radiators and fans on the rear panel of the device.

Temperature and content of the nitrogen oxide are the basic physical chemistry parameters of the NO‐containing gas flow. The temperature of expiration is ~4000 °C for the destructor and ~1000 °C for the coagulator (Fig. 3). It should be noted that the molecule of the nitrogen oxide possesses active oxidation potential and in the air medium enters into reaction with molecular oxygen, forming a chemically resistant compound ‐ the nitrogen dioxide (NO2), which will always be present as a result of this in the NO‐containing gas flow. The application of the standardized generator part of all manipulators makes it possible to reach flows with identical axial content of nitrogen oxide, what is also shown in Fig. 3. Range of the obtained concentrations of NO is very wide ‐ from 2500 ppm to 0. This makes it possible to select those parameters, which the doctor considers to be most acceptable for specific purposes. The analysis of dependence of temperature and content of the nitrogen oxide on the axis of gas flow shows that the device allows an enormous field of possibilities on the combining of the thermo‐physical and biochemical factors of action on the biological tissues and objects.

Fig.3: The temperature of flow is rapidly reduced with the distancing from the outlet of manipulator and at a distance 100 mm does not exceed 100°C. The content of nitrogen oxides on the axis of gas flow is represented in the second graph.


5.2.1 Coagulation of the wound surfaces Coagulation is achieved by bringing the high‐temperature air‐plasma flow (HPF) directly to the wound surface. The temperature of flow in the region of contact must be not less than 2000 °C, therefore, the distance from the outlet of coagulator to the region of action must be not more than 25 mm. In the first step (Fig. 5A) during application of HPF with temperature higher than 2000°C to the biological tissue, its heating to the boiling point of woven liquid occurs. Compact layer of necrosis (CLN) is formed, which consists of the degradation products of protein connections, partially damaged and nonviable, but with their structure cells preserved (55°C), and the zone of paranecrosis ‐ with partially reversible changes in the cells. Subsequently the zone of paranecrosis becomes the source of regeneration.

Fig. 5: Coagulation of the wound surfaces The further increase of the time of action (Fig. 5B) leads to strengthening of the process of boiling and evaporating the woven liquid. The spongy layer of necrosis (SLN) is formed ‐ the porous, elastic and airtight structure, which consists of the dehydrated protein and fatty connections. Clearly expressed physical boundary of the evaporation of liquid appears in the cloth, which divides the spongy (SLN) and compact (CLN) layers of necrosis (100°C). Upper temperature boundary of the spongy layer of necrosis coincides with the temperature of the beginning of the thermal decomposition of protein

Work regime A

Work regime B

Fig. 4: Two operational regimes of PLASON device work


and fatty compounds into the simplest chemical elements (550 °C, Fig. 5C). Above SLN the carbonized (carbon) layer of necrosis (CaLN) is formed, which is the burnt and charred cloth. Qualitative hem‐aero‐lymph‐cholestasis is determined by the positive dynamics of shaping of the compact and spongy layers of necrosis or by the low rate of shaping of the carbon layer of necrosis. The thermo‐physical and geometric parameters of the plasma flow of coagulator are optimized so that reliable hem‐aero‐lymph‐cholestasis is reached on any biological cloths and at any speeds of counter blood flow. The significant (about 200 m/s) discharge velocity of hot gas from the outlet of coagulator creates condition on the surface of the coagulated section of the cloth, with which coagulation layers are formed directly from cloth itself, but not of the counter‐flows of the liquid, for example, of the blood or lymph entering. A change in the time of action and distance from the outlet of coagulator to the region of coagulation is the universal method of the dosage of the energy necessary for the coagulation. For obtaining the reliable coagulation the distance from the outlet of manipulator lies within the limits from 2 to 25 mm.

ATTENTION!

In practice hem‐aero‐Iymph‐cholestasis can be achieved also without completeshaping of the entire region of thermal changes. Coagulation effect begins, for example, and without the formation of the carbon layer of necrosis.

5.2.2 Sparing coagulation of the wound surfaces In a number of cases, when the intensive entering of liquid (for example, the blood or of lymph) from the deep layers of cloth to the surface is absent, it is necessary to conduct partial drying surface in the regime of the sparing coagulation for the purpose of the final evaporation of pathologic liquids (for example, exudate) and achievement of the effect of sterilization. For achievement of the effect of partial drying and tasks formulated above there is no need for using the entire temperature potential of air‐plasma flow (HPF). Sufficient to ensure in the place of the contact of plasma jet with the cloth temperature in the range from 1000 °C to 2000 °C. The flow charts of the sparing coagulation are shown in the figure. The sparing coagulation can be carried out by the coagulator (Fig. 6A), as well as by stimulator‐coagulator (Fig. 6B). With the use of the coagulator the distance from the outlet to the region of coagulation must be not less than 25 mm. Visually this approximately corresponds to the end of the luminous part of the plasma torch of coagulator. The decrease of distance from the outlet to the region of coagulation will lead to excess temperature limit to 2000 °C. The thermo‐physical processes, proceeding during the sparing coagulation, are in many respects similar to the processes, proceeding during the traditional coagulation, but in this case low temperature potential flow does not make possible to be formed for the complete region of thermal changes. Process is limited to the formation of the small zone of spongy necrosis (SLN), zone of compact necrosis (CLN) and zone of paranecrosis. As a result of this action an elastic film of lusterless nuance with a thickness not of more than 200 mkm is formed on the surface of cloth, which also is the purpose of the sparing coagulation.

Fig. 6: Sparing coagulation When conducting the sparing coagulation by stimulator‐coagulator the distance from the manipulator outlet to the cloth is minimal (Fig. 6B), since the temperature of the escaping flow does not exceed 1000 °C. This way, if it is necessary to realize the sparing coagulations on large surface, it is possible to use a coagulator, and if it is necessary to coagulate the bound spaces ‐ stimulator‐coagulator.

ATTENTION! For obtaining an uniform coagulative membrane it is necessary to constantly change the angle of the tilting of plasma flow about the wound surface according to its relief.


5.2.3 Technology of conducting of the sessions of NOx‐therapy by coagulator and by destructor Any manipulator for the action of exogenous nitrogen oxide on the biological subjects allows using of various generator parts. Temperature factor is a fundamental physical limitation for applying of the NOx‐therapy technology as a whole. The optimal temperature of action is determined by the following conditions: 1) the absence of possible thermal damages of cellular structures; 2) by the absence of the sensations of thermal discomfort in patient. Practice has shown that the optimal temperature of the flow is 40 ± 10 °C. This is less than the temperature of the beginning of protein connections denaturing, and also creates a pleasant sensation of blowing warm air at the patient. Minimum distance from the outlet to the object, with which it is possible to carry out the sessions of the NOx‐therapy by coagulator or by destructor, is 150 mm. The flow chart of conducting the sessions of NOx‐therapy is shown in the Fig. 7. The NO‐containing gas flow (NO‐CGF) is directed to surface desirably at right angle.

Fig. 7: NOx‐therapy by coagulator and by destructor Bright luminescent spot on the surface (optical and geometric projection of the outlet of manipulator on the surface) helps the user to determine the center of flow and to direct it in the necessary direction. In this case, a stationary circular region with the increased content of the nitrogen oxide is formed in the region of the contact of flow with the surface. Maximum concentration of NO is observed on the axis of gas flow and it falls to the periphery smoothly. Concentration of NO and NO2 on the centerline of gas flow is determined by the physical chemistry flow parameters (temperature and the content of oxides of nitrogen ‐ fundamental characteristics of the air‐plasma flow). The effective scope diameter of the workable surface NO ‐ CGF can be estimated according to the simple formula:

4

mm object, ther tomanipulato ofoutlet thefrom Distance diameter Scope

If the geometric dimensions of the workable region or object are greater than the scope diameter, working is conducted by scanning, linear or circular motions with a movement speed of approximately 0.5‐1.5 cm/s.

ATTENTION! The diameter of luminescent spot is lower than the diameter of the seizure of the workable surface. Luminescent spot only allows to correctly direct the center of the air flow, which contains the nitrogen oxide.

ATTENTION! When conducting NOx‐therapy sessions by coagulator or by destructor it is necessary to maximally attentively check the distance from the outlet of manipulator to the region of working to avoid the possibility of causing thermal damages.


5.2.4 Technology of conducting the sessions of NOx‐therapy by the stimulator‐coagulator Stimulator‐coagulator as a device with a cooler part connected to the generator generates gas flow, which contains nitrogen oxide, with temperature potential smaller than coagulator or destructor. When conducting the sessions of NOx‐therapy , this makes it possible to bring the manipulator nearer to the biological subject and as a result, create higher concentration of NO in the near‐surface layers. The flow chart of conducting the sessions of NOx‐therapy by stimulator‐coagulator is shown in the Fig. 8A. According to the dependence of the content of the nitrogen oxide on the axis of flow, minimum distance from the outlet to the surface, where the temperature will not exceed 40 ± 10 °C, is about 80 mm (temperature and the content of oxides of nitrogen are the fundamental characteristics of air‐plasma flows). Directed desirably in the right angle to the workable object, flow will smoothly spread in parallel to surface, creating axisymmetrical region with an increased content of nitric oxide. The center of luminescent spot indicates the user, where the flow is directed at the given moment. The effective scope diameter of the workable surface is defined as ¼ of distance from the outlet of manipulator to the surface. For averting the possibility of causing thermal damages the manipulators are finished with a thread for installation of the detachable thermal spacer, whose application makes it possible to fix the physical chemistry parameters of flow (Fig. 8B). Thermal spacer is either manufactured as a hollow cylinder with wide lateral windows or a cylindrical base with a narrow distancing needle. Its length assures that the temperature of the NO‐containing gas flow (NO‐CGF) on the end of spacer reaches 40 ± 10 °C, in this case the concentration of the nitrogen oxide will have a value of ~750 ppm. The installation of thermal spacer does not introduce changes in geometric parameters of NO‐CGF. The effective scope diameter is ¼ from the distance of the maximal possible approximation of stimulator‐coagulator which is ~20 mm.

Fig. 8: NOx‐therapy by stimulator‐coagulator

ATTENTION! During continuous operation of manipulator with thermal spacer attached, the spacer may become hot. Avoid the contact of the spacer with biological tissues.

5.2.5 Technology of conducting NOx‐therapy sessions by narrowly‐directed cooled NO‐containing gas flow. The application of additional cooler of labyrinth type allows to completely cool the air‐plasma flow (APF) to ambient temperature. To obtain a narrowly‐directed NO‐containing gas flow (NO‐CGF) of ambient temperature it is necessary to establish any manipulator into the cooler tube and start the device work. The cooled flow will be delivered to the object through a flexible silicone tube and a metallic tip, a thin‐walled tube with a diameter of 4 mm from biologically inert materials. Localization and focusing is achieved by the calibration of the tip outlet. The optimum diameter of the outlet for NOx‐therapy is less than 1 mm. The application of narrowly‐directed cooled NO‐CGF allows acting on the region of pathology from any distance to 250 mm. The cooling of NO‐containing gas flow allows using it when working in cavities in different variants.

Fig. 9: Cooled NO usage


Variant 1. If cavity has a form of pocket and the opening, which connects it with the surrounding space, is bigger than the diameter of the metallic tip, then the tip is directly introduced into the opening. Air in the cavity (pocket) is displaced by forced NO‐CGF. The atmosphere with the increased content of the nitrogen oxide is created after a certain time in the cavity.

ATTENTION!

When using narrowly‐directed NO‐CGF, choose procedure duration with attention since at small distance of the tip to the surface of processed object, high concentration of NO is formed.

Variant 2. Connection of metallic tip to the already existing or specially created vent lines allows processing of almost any internal cavities by nitrogen oxide. Here the metallic tip is air tightly connected to the vent line (tube of supply) fixed in the cavity. NO‐CGF is then introduced into the cavity, and the gas from the cavity flows out through another tube, which connects the cavity with the surrounding space (tube of discharge).

Fig. 10: Variants of cooled NO usage

ATTENTION! When working in the cavities through the opening it is necessary that the metallic tip would enter into the opening with a clearance for drainage of gas. Otherwise appearance of excess pressure in the cavity is possible.

The version of working in cavities with the aid of the two‐clearance drainages (Fig. 10.1) or of the coaxial (tube in the tube) version of NO‐CGF introduction into the cavity (Fig. 10.2), and also the supply of the nitrogen oxide to the region of pathology through the puncture needles and the biopsy channels of endoscopic instruments are possible.

Fig. 11: Various forms of cooled NO‐CGF introduction tips

ATTENTION! During the supplying of nitrogen oxide into any cavity it is necessary to ensure its drainage for exiting of the "waste" gas into the surrounding space.


5.2.6 Destruction (dissection)

Basic difference in the manipulator‐destructor from the coagulator is the diameter of outlet (coagulator 1.2 or 4 mm, destructor 0.7 mm). This allows to aggravate and concentrate the air‐plasma flow (APF) energy and to increase the speed of its expiration. In working of living biological tissues by the concentrated and aggravated APF, the carbon layer of necrosis is heated to the temperature of ~800°C and it begins to be decomposed into small particles ‐ to sublimate, and high‐speed flow exhausts the decay products of CoLN from the zone of action. With this dynamics the carbon layer of necrosis ceases to be the natural heat shield as in the case of coagulator, and entire structure of the region of thermal changes is moved into the depths of the cloth. As a result, a zone of destructured cloths is formed, surrounded by the coagulation layer, which ensures reliable hemostasis.

Fig. 12: Destruction (dissection) Effective distance from the outlet of manipulator must be the smallest possible. This allows obtain qualitative section with causing smallest possible damages to the adjacent cloths and organs.

ATTENTION! During destruction or dissection of the hollow organ walls the danger of damage of their internal surfaces as a result of the penetration through incision of hot gas can arise.

5.2.7 Technology of obtaining antiseptic solution on the basis of hydrogen peroxide and nitrogen oxide (solution of Aleksandrov M.T.)

To produce an antiseptic solution on the basis of hydrogen peroxide and nitrogen oxide it is necessary to dissolve the specific quantity of NO in 3% solution of hydrogen peroxide. The low solubility of the nitrogen oxide in the aqueous solutions does not make it possible to prepare this solution without the application of technology of bubbling. Flow chart is shown in the Fig. 13. A transparent tank is filled with fixed quantity of 3% solution of hydrogen peroxide. The metallic tip of the supply of the NO‐containing gas flow (NO‐CGF) is introduced through the tightly closed cover in such way, that the outlet of the tip is located below the level of liquid in the tank. Additionally, the cover has a vent tube, connecting the empty space of the tank with the ambient space. With the starting of the device "PLASON", NO‐CGF enters directly into the 3% solution of hydrogen peroxide in the form of bubbles, saturating peroxide by the nitrogen oxide. The optimum time for the preparation of solution depends on the volume of the prepared solution and is determined by the formula:

t = 0,06∙ V

where the V is volume of the solution in ml, t ‐ time of bubbling in min.

Fig. 13: Technology of preparing of antiseptic solution The obtained solution can be used in the therapeutic process immediately or in the course of 20 days if stored in a cool, place protected from the light.

ATTENTION! Obtaining solution with the described technology must be conducted in the exhaust hood or in a room equipped with exhaust ventilation.


5.3 Control systems of PLASON For the control of work of manipulators and the device the device is supplied with the system of the sound communication, which forms the appropriate sound signals with the presence of disturbances or malfunctions. Table 2: Control systems of PLASON

Name of the system

Functions Effect Audible sidnal

Visual signal

Temperature control system

Coolant Temperature Control (CTC)

1. When coolant temperature reaches 32 ± 2 °C: ‐ second (intensive) cooling stage is initiated

2. When the coolant temperature reaches 50 ± 2 °C: a) the manipulator turns off; b) blocking of start until the coolant

temperature is lowered to 45 ± 2 °C.

Coolant consumption control system

Quality control of flow rate and amount of coolant

1. When the flow of coolant is reducedbelow 0.8 ± 0.1 liters / minute: a) the manipulator turns off; b) blocking of start until the coolant

flow rate is restored

Continuous beep signal

Flashing red LED on the control panel (inside the device, only for technicians).

2. Violation the continuity of coolant flow (bubbles): a) the manipulator turns off; b) blocking of start until the coolant

flow rate is restored

Continuous beep signal

Flashing red LED on the control panel (inside the device, only for technicians).

Level control system of coolant

Control the coolant level

1. The volume of coolant decreases by 0.25 liters: a) the message by beep signal.

Intermittent beep signal

Flashing green LED on the control panel (inside the device, only for technicians).

5.4 Remote Control of the Device For the remote control of the starting and stopping of work with manipulators the device is equipped with a pedal. In order to use the pedal for operating the device remotely, connect it to the pedal connection on the front panel. When the pedal is pressed down, the manipulator starts working. Once the pedal is released, the manipulator stops working immediately.

Fig. 14: Pedal for PLASON remote control

6. INDICATIONS ON SECURITY MEASURES

6.1. Use the device only after thorough study and with observance of requirements, presented in this User´s guide.

6.2. Work only with original manipulators. When a failure is detected it is necessary to send the device to the EU representative (ONKOCET Ltd.) for repair and testing.

6.3. The operation of device in a room, where combustible anesthetics have been applied, is forbidden.

6.4. Connection to the electrical network must be through the protection from short circuit (automatic switches, fuses, safety devices).

6.5. It is forbidden to use the device with the cover of service block removed.

6.6. Before conducting of surgical interventions with the aid of the device the surgeon is obliged to become acquainted with the action of plasma flow on soft tissues by trial actions on the damp meat.


6.7. Special attention is required when switching manipulators to set them up on the manipulator tube correctly.

6.8. When working with the device it is strictly forbidden to subject any objects under the plasma flow, other than the treated surface of the patient’s body. Don’t screw any objects on the tip of the manipulators.

6.9. Continuous operation of the device is possible only in the premises, supplied with exhaust ventilation.

6.10. Use only prescribed cooling fluid to fill into the cooling system of the device. Using other substances can damage the device and will result in void warranty.

6.11. Use only the supplied footswitch to operate the device remotely.

6.12. Avoid long or very close‐distance exposure of human tissues to protect from burns. Follow feedback from the patient in order to state the comfortable application distance or use the provided distance.

6.13. It is recommended to use Plason in rooms with temperature up to 25 °C and humidity up to 80 percent.

7. ORDER OF INSTALLATION AND THE PUTTING INTO OPERATION

7.1. Extract the device from the transport package.

7.2. Verify the completeness of device.

7.3. Place the device on a horizontal surface. Arrangement must ensure free access to the control elements and their convenient observation.

7.4. Unscrew and remove the red transport plug from the bottom of the device.

7.5. Connect the foot pedal to the device.

8. PREPARATION OF DEVICE FOR OPERATION

8.1. Device is delivered to the user in completely assembled form with a manipulator set up on the end of the flexible EHP supply tube. Remove the red screw plug from the bottom of the device prior to its operation. The red screw is used for locking of the overflow discharge tube for transport. The preparation of device for the work consists in checking of its fitness for work with different manipulators with different operating modes on the air flow rate.

8.2. Make sure that the network supply rosette has a grounding contact. In the case of its absence ensure the installation of network supply rosette with a grounded contact.

8.3. Set the “ON/OFF” switch into the initial state ‐ position “0”.

8.4. Plug the network cable of the device in a socket with the supply voltage 230 V of 50 Hz with the permissible current not less than 6 A.

8.5. Start the device via the “on/off” switch from the position “0” to the position “I”. When done, the “on/off” switch, the “STOP” button and one of the control buttons of airflow “MIN”, “NORM” or “MAX” are illuminated; pump and cooling‐system fans of device begin to work.

8.6. Establish the maximum air flow rate by pressing of the “MAX” button.

8.7. Start the work of the coagulator by pressing the button “START”. Normal operation of device and coagulator is shown by glowing “START” button, by a sound signal and by outlet of steady plasma torch from the coagulator.

8.8. Establish the minimum air flow rate by pressing the “MIN” button. The air flow rate through the coagulator must decrease.

8.9. Turn off the manipulator by pressing of the “STOP” button.

8.10. Turn off the device via the “on/off” switch from the position “I” to the position “0”.


8.11. Remove the coagulator from the tip of the EHP supply, after unscrewing of the adapter nut, which connects the manipulator and the EHP supply tube. If necessary, use the special tool, fixed on the rear wall of device.

8.12. Establish a destructor (yellow marking) on the EHP supply tube by screwing the adapter nut thoroughly. Before the installation of manipulator to the EHP tube check for moisture tracks presence and wipe them with a gauze napkin.

8.13. For functional test of the device and destructor repeat the actions in sequence 8.5‐8.10.

8.14. Establish a stimulator (green marking) on the EHP supply tube, after carrying out actions in sequence 8.11, 8.12.

8.15. For the functional test of the device and stimulator repeat the actions in sequence 8.5‐8.10.

8.16. For the functional test of the device in the regime of remote control start with any manipulator mounted on the EHP supply tube by pressing of the pedal; “START” button glowing, the presence of sound signal and outlet of steady plasma torch from the manipulator testify about the normal operation of the device.

8.17. Release the pedal ‐ the flow from the manipulator must be stopped and device should go into the state as in 8.5.

8.18. Disinfection of the external surfaces of device and manipulators can be done by five‐step working, each of whom consisting of two rubbings of external surfaces with a gauze napkin, moistened by 3% solution of hydrogen peroxide by GOST 177‐88 (national standard) with the addition of the cleaning agent according to the GOST 25644‐96 (national standard) or by 1% chloramine solution, according to technical specifications TU 9392‐031‐00203306‐2003.

8.19. Device is ready for operation.

8.20. During the intra‐operating application of the device a sterile sleeve should be put on the EHP supply from cotton cloth or the EHP supply should be wrapped into a sterile sheet (towel).

The sterilization of manipulators should be carried out by chemical gas methods by ethylene oxide or by formaldehyde. The sterilization of manipulators in UV or gas‐formalin chamber, and also by rubbing with different solutions with the subsequent covering up of manipulator into the sterile napkin is possible.

ATTENTION! Moistening of manipulators is not allowed!

9. OPERATIONAL PROCEDURE

9.1. Set “on/off” switch into the initial state ‐ position “0”.

9.2. Plug the network cable of the device in a socket with the supply voltage 230 V of 50 Hz with the permissible current not less than 6 A.

9.3. Select and connect the required manipulator to the EHP supply tube.

9.4. Start the device via the “on/off” switch from the position “0” to the position “I”.

9.5. Select the requested air flow rate by pressing the button “MIN”, “NORM” or “MAX”.

9.6. Start the manipulator by pressing the “START” button or by pressing of the foot pedal.

9.7. Carry out the necessary surgical or therapeutic procedures.

9.8. Turn off the manipulator by pressing the “STOP” button or by releasing of the foot pedal.

9.9. Turn off the device by setting the “on/off” switch to position “0”.

9.10. Take out the fork of the electric supply cable from the electric plug.

9.11. During the interruptions between therapeutic actions (procedures) it is recommended only to turn off the manipulator by pressing the “STOP” button and not to turn off the whole device by the “on/off” switch until the end of the outlined cycle of procedures.

9.12. To transfer the device into the working regime B (cooled NO‐CGF regime), the threaded “GAS COOLER” cap, which closes the tube of the built‐in cooler on the upper panel of device, should be removed. Blue manipulator should be inserted into the tube to the maximum possible depth (don´t use excess force). It is recommended to fix the


threaded cover to its holder, located on the rear bracket of the knob of the device, opposite the built‐in gas cooler.

9.13. Transfer from work regime A into regime B and vice versa must be done only when the manipulator is turned off.

Table of possible malfunctions

Designation of malfunction, external manifestation and additional signs

Possible reasons Method of the elimination

1. When switching on the device by the “on/off” button the cooling liquid leaks from the manipulator outlet.

Non‐hermetic state of the manipulator cooling system.

Replace the manipulator.

2. The manipulator does not start when the “START” button is pressed. The “START” button is not illuminated.

1. Manipulator reached the end of its lifetime.

2. Malfunction of electric power supply system.

1. Replace the manipulator2. Contact the producer or

official representative.

3. When switching on the device by the “on/off” button or when the manipulator is started, an intermittent sound signal is occurring.

Insufficient amount of liquid in the cooling system.

Add the cooling liquid.

4. When switching on the device by the “on/off” button a continuous sound signal is present; it is not possible to start the manipulator by the “START” button.

The malfunction of cooling system (there is an unsufficient flow rate of the cooling fluid).

Contact the producer or the official representative.

10. THE MAINTENANCE

10.1. For guaranteeing the reliable work of device to conduct timely maintenance.

10.2. To follow the cleanliness of device and manipulators. External surfaces of device and manipulators to disinfect on p. 8.18. present passport.

10.3. To conduct daily maintenance with the regular work with the device.

10.4. Monthly maintenance by regular operation of device is carried out by medical staff that exploits the device.

10.5. Annual servicing of device with the regular work with it to carry out not less than one time per year.

10.5.1. Plug the device out from the electric network, remove the cover of service block.

10.5.2. Clean the dust from internal spaces of device, using vacuum cleaner.

10.5.3. Look around thoroughly through the installation, paying attention to the presence of clearances between the components, the exterior view of the elements of installation, the integrity of wire insulation, fastening units.

10.5.4. Periodic annual maintenance is carried out by the specially prepared operating personnel.

11. WARNINGS AND SAFETY NOTICES

11.1. Modification of this equipment is not allowed. Hazards can result from unauthorized modification!

11.2. Putting fingers into openings of the device intended for holding of manipulator is prohibited. 11.3 Using of PLASON in an oxygen rich environment is forbidden. An unacceptable risk of fire is considered to exist in an

oxygen rich environment when a source of ignition (plasma) is in contact with ignitable material and there is no means that would limit the spread of fire.

11.4 It is forbidden to use PLASON with flammable anesthetics. 11.5 It is forbidden to use PLASON in conjunction with flammable agents.

11.6 It is forbidden to use PLASON when the operating staff is under the influence of alcohol, and medicines negatively affecting performance and attention.


12. LABELING

Front panel

Back panel

REMOVE THE RED PLUG ON THE BOTTOM OF THE DEVICE BEFORE FIRST USE!

The instructions for use describe the nature of the HAZARD and the precautions for avoiding it or minimizing the associated RISK.

Warning ! Keep the end of manipulator in

minimal distance 20 cm away from the body of patient or operator

before pressing the START button.

Attention! Screw in the red plug to the outlet

channel at the bottom of unit before transportation.

Attention! Please remove the red plug on the

bottom of the unit before use.

Warning ! Don’t put fingers into any of the

openings of the device.


13. DISPOSAL OF PRODUCT AND PACKAGING

DISPOSAL OF PACKAGING - packaging components (cardboard, plastics etc.) are all classified as solid waste and can be therefore easily disposed of with the use of recycling processes.

Before disposal is always advisable that you check the validity of the relevant provisions in the place of installation. PLEASE MAKE proper disposal!

PRODUCT DISPOSAL – PLASON is made of various materials. Most of them (plastic, metal, electric conductors, etc.) may be handed over in recycling sites and can be recycled. However, other components (electric plates, etc.) may contain hazardous substances. Therefore the following components should be submitted in the respective centers or the European representant of the producer, where the qualified ensure their disposal. Before disposal is always advisable that you check the validity of the relevant provisions of the disposal site. PLEASE MAKE proper disposal!

14. STORAGE AND TRANSPORTATION OF PLASON The PLASON device should be transported and stored in the following conditions: ambient temperature from +5C till + 40C; relative humidity less than 80%; avoid aggressive vapor in the air; avoid dusty spaces; avoid direct sunshine; avoid strong electric and magnetic fields; avoid moist environment. Lifetime of the PLASON device, if the conditions of usage, storage and transportation meet the requirements of present User’s manual, is 7 years. Warranty repairs are made by: Manufacturer:

CJSC “Center BMSTU” 2nd Baumanskaya, 5, bld. 1, 105005 Moscow, Russia

or the authorized service centres: Authorized representative in European Union:

Onkocet Ltd. 4 Kutuzova str., 90201 Pezinok, Slovakia, tel.: 421 244 64 09 77

e-mail: [email protected]

All valid permissions and certificates are placed on the homepage of European Representative www.onkocet.eu

Last revision: November 1st 2014

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