RC ART DENAS MS Vertebra 2

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Overview

DENAS®-Vertebra 2 Operation Manual

DENAS®-Vertebra 2 Operation Manual

Function Description

The DENAS-Vertebra-2 device is intended for the conduction of dynamic electrostimulation and electromassage. It can be used for pain relief and correction of functional disorders under various diseases of internal organs, as well as for rehabilitation after previous diseases, surgical interventions, and traumas. The device aims to enhance the adaptive capacity of the organism under physical and mental strain. It can be used as a primary method of treatment when drug intolerance or contraindications for other methods exist, as a component of complex treatment to enhance the effect of primary drug, homeopathic, manual therapy, mental therapy, and other methods, or as a symptomatic treatment for various diseases and syndromes.

The device operates by applying short asymmetrical bipolar current pulses, which vary depending on the electrical resistance of tissues in the zone under electrodes. This method is safe, simple, and has minimal contraindications. DENAS has been successfully applied in many fields of medicine, with extensive data on the benefits of neurostimulation in the treatment of various diseases of adults and children. The device allows for simulating massage effects, due to muscle contraction, and the effects and feelings during electromassage are comparable with manual massage, often surpassing it due to deeper treatment of muscles.

Important Technical Specifications

Maximum current consumption:

In electrostimulation mode: no more than 300 mA
In switched off mode: no more than 100 uA

Weight of the device without batteries:

Electrostimulation module: no more than 5,000 g
Control panel: no more than 180 g

External dimensions:

Control panel: 140x55x28 mm
Electrostimulation module: 900x365x70 mm

Automatic shut-off: The unit automatically shuts off after three minutes since the last pressing of any button, except the power button, when programs of the device are not used.

Parameters of separate impulses of impact:

Under minimum power level:
- Duration of positive part of impulse (T1f): 32 ± 9 us
- Amplitude of positive part of impulse (A1f): no more than 40 V
- Impulse swing (Ap-p): no more than 70 V
Under maximum power level:
- Duration of positive part of impulse (T1f): 300 ± 90 us
- Amplitude of positive part of impulse (A1f): 40 V
- Impulse swing (Ap-p): 200 ± 60 V

Parameters of the mains supply:

Input AC: 220 V / 50-60 Hz
Output: 5.0 V / 500 (1000) mA
Galvanic isolation: (Class II)

Battery type: LR6/AA (2 pcs)

Usage Features

Safety Measures:

Pay attention to all information marked with a "!" sign, as it is important for safety and proper use of the device.
The device is safe for use, but it utilizes an internal power source of low voltage, which is isolated from the work part of the device (article of type B with body of type F).
The device must not be used for treatment of patients with implanted electronic devices (e.g., pacemakers) and for treatment of patients who have individual electric current intolerance.
Do not use the device in direct front projection of the heart.
Do not treat patients with any high-frequency electric device during stimulation; simultaneous use of the device and other electric equipment can cause burns and lead to possible damage of the device.
Do not work near short-wave and microwave equipment, as it can bring instability of output parameters of the device.
It is prohibited to use batteries that are different from specified by the manufacturer. Use of inappropriate batteries can lead to device malfunction and also result in electric shock.
Do not use the AC power source other than the one supplied by the manufacturer. Using a different power supply may seriously affect the safety of the user and device health.
It is prohibited to deform the module of electrostimulation.
The device contains fragile components. Protect it from shocks.
Protect the device from influence of direct sunbeams under high (>25 °C) air temperatures. It can lead to malfunction of the device indicator or destroy batteries.
The device is not waterproof. Protect it from ingress of moisture.
All works on maintenance and repair of the device must be executed by qualified specialists of the manufacturer.
Attention! Before using the machine, make sure that the mains voltage complies with the power supply. It is forbidden to use the AC power with the discrepancy between the network settings.
Attention! Prevent the device or its parts (control panel, utility power source) from falling on the ground.
Attention! Avoid damage to the control panel display.
Attention! If the patient is running through a course of other physical therapy, use of the device is possible only under approval of attending physician.

Transportation, Storage, and Operational Conditions:

Transportation conditions: temperature from -50 °C to +50 °C, relative air humidity from 30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg).
Storage conditions: temperature from -50 °C to +40 °C, relative air humidity from 30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg).
Operational conditions: temperature from +10 °C to +35 °C, relative air humidity from 30 to 93%, atmospheric pressure from 70 to 106 kPa (525 to 795 mm Hg).
Attention! If the device has been stored at a temperature below 10 °C, keep it in normal climate conditions for no less than 2 hours before use.
Utilization: All packaging materials are not environmentally harmful; they may be used repeatedly. Separate collection of electrical and electronic equipment. Product disposal is technically possible. The product poses no danger to human life, health, and the environment after the end of its life (operation) and does not require special measures for preparing and shipping the compound parts of the product for recycling.
Attention! The device contains valuable materials, which can be used repeatedly after utilization with consideration of requirements of environmental protection. They shall be delivered to specially intended for this purpose places (consult with corresponding services in your district) for collection and processing.

Contraindications:

Idiosyncrasy
Presence of an implanted pacemaker
Status epilepticus
Neoplasms of any etiology and distribution
Vein thrombosis
Acute agnogenic febrility
State of acute mental excitation of alcohol or drug origin
Attention! There have been no controlled researches on impact of the device on pregnant women, so the device should be used only if it is absolutely necessary, after consultation with the attending physician.
Attention! In the case of presence of above contraindications, possibility of use of the device should be discussed with a doctor.
Attention! Use of the device in direct front projection of heart is prohibited.
Attention! It is prohibited to use the device in presence of solution of continuity of skin (wounds, skin diseases) in zone of impact.

General Provisions for Treatment:

For applying of treatment with the help of the device, there is no need to observe any special conditions. The device should be placed in a warm room on a hard flat surface (medical couch, floor), length and width of which should correspond to that of the patient. After the procedure, it is recommended to relax for 10-15 minutes.
Patient should be located on the module of electrical stimulation in such a way that majority of the electrodes along the length of patient contact with the skin surface. Otherwise (under absence of skin contact or under contact with less than 60% of electrodes) program may not start or stop at one of its stages. Most of programs of the device, regardless of selected zone, have one or more phases of stimulation along whole surface of the back. In case when during this phase part of electrode groups will not contact with the skin, the device will abort program due to impossibility of its further implementation.
When properly positioned on the module of electrical stimulation, upper paired electrodes are in the zone of neck just below the hairline, and central electrodes are in contact with your skin in projection of the spine. In case of inconvenience, associated with hyperextension of cervical spine, small pillow, folded towel, or similar object can be placed under the head.
Automation of the process of treatment provides ease and convenience of procedures conduction. During the session, the device switches electrodes and stimulation frequency in order, specified by the program. Combination of certain switching speeds and frequency of impact secure simulation of massage effect, which is most fully manifested under use of comfortable and maximum power levels.
Attention! Programs of the device consist of several phases, which subsequently change each other. Each phase has different parameters of stimulation, including repetition rate of impulses. Under changing of phases, subjective feeling of change of impact power level is possible. In case of appearance of sense of discomfort, adjust the power, using the appropriate buttons on control panel.
Attention! During the work in 9th phase of program E (see. P. 9.5.5) 11 minutes before the end of the program, automatically set up to the minimum power level, wherein is not possible to increase the power by using a keyboard. This is not a malfunction of the unit and is necessary for the correct operation of the program.
Attention! E program ends after the 9th phase (see. p. 9.5.5) in case if additional stimulation zone is not defined. This is not a malfunction of the system and depends on the current state of the organism of the patient.

Determination of Intensity (Power) of Impact:

The level of energy treatment with impulse current is determined individually based on subjective sensations of the patient. Intensity of electrostimulation is conditionally divided into three levels.
The first, minimal level - patient does not have any subjective sensations or has subtle vibrations in area of impact under electrodes. This level is used when treatment shall not be intensive – for patients with diseases of cardiovascular system (hypertension, hypotension, a syndrome of vegetative-vascular dystonia). For patients who are experiencing frequent headaches, dizziness, treatment should also be carried out with minimal power.
The second, comfortable level - patient feels light pricking, vibration, or light burning without pain. It is used under treatment of weak pain and aches of medium intensity. This is the most frequently used power level.
The third, maximal level - patient feels expressed painful pricking or burning. Such intensity can be accompanied by involuntary contraction of muscles close to electrodes. It is used under expressed pain syndrome.
Attention! Control of power level is executed subjectively, considering sensation of patient. You shall not exceed pain threshold.
Attention! For patients with hypertension, hypotension, a syndrome of vegetative-vascular dystonia, as well as patients who have frequent headaches, dizziness, treatment should be carried out with minimal power level.
Attention! Power of electrostimulation can be increased or reduced during the treatment course depending on the extent of the patient’s sensitivity and as pain is relieved.

Preparation for Treatment:

Open the consumer box and remove the device. There is no battery in the battery compartment, set the power supply or connect to the AC adapter as shown in Fig. 5.
Attention! It is prohibited to use the machine if it is damaged.
Attention! It is prohibited to use the machine if indicators of control panel are damaged.
Attention! If the device has been stored in cold environment or in high humidity conditions, keep it under normal room temperature for no less than 2 hours before use.
Attention! Treat the device electrodes with a standard disinfection means (such as 3% solution of hydrogen peroxide) after each procedure.
Install the power supply according to its polarity. Before starting to operate the device, make sure that the control panel, as well as the module of electrostimulation, have no traces of drop or stroke, device display is not broken, the connecting cable is not damaged. Also, make sure that the electrodes have no traces of foreign substances or damage.

Order of Conduction of Treatment Session:

Put safety sheet on the surface of the module of electrostimulation and carefully secure it.
Switch on the device with the power button.
Select the program of impact by pressing the program button the necessary number of times.
Select the zone of impact by pressing the zone button the necessary number of times (available for programs B, C, D).
Set the necessary power level by pressing the (+) and (-) buttons.
After the end of the session, switch off the device by pressing the power button.
After the end of the session, it is recommended to relax for 10-15 minutes.

Lay-out of Sheet: Get one sheet, specifically designed for the device, from the packaging. Place it on the electrode surface of the module of electrostimulation in such a way that the holes of the sheet fully match the location of the electrode groups. Place the sheet below the level of the electrode groups, so that it will be drawn tight and securely fastened.

Switching on the Device: Prepare the device for conduction of the procedure. Press the power button on the control panel. The device will switch on and switch to standby mode.

Selection of Impact Program: Upon switching on the device, program A is used by default. To select the required impact program, press the program button. Programs are located in the menu in the following order: program A → program B → program C → program D → program E → program A...

Selection of Impact Zone: For programs which are associated with the necessity of selection of impact zone (programs B, C and D), use the zone button. If indicated on the display, the zone does not correspond to the area of wanted stimulation, shift stimulation zone up and down, depending on your choice.

Start of Program and Setting of Power Level: Comfortably position yourself on the module. Under contact with skin of more than 60% of electrodes in the selected zone, a symbol will be shown on the display – indicating the presence of contact of the device with skin. Start of the program is executed by pressing the (+) button under presence of contact of electrodes with skin. If the device cannot detect the presence of contact, use the function "Therapy without control of contact." The "Therapy without control of contact" allows to carry out the procedure in the absence of contact or unstable contact of the electrodes with the patient’s body. To activate the "Therapy without control of contact," press the (+) button and hold it before setting a power.

Attention! Function "Therapy without control of contact" operates during one session. To apply it for the next session, it is necessary to activate it again. To select power level, use the (+) and (-) buttons. Single pressing changes power level for one point. Holding a button for more than 1 second will lead to consistent change of impact level. After selection of required level, release the button. Countdown of impact time will begin.

Recommendations for Carrying Out Procedures: For carrying out procedures using the device DENAS-Vertebra-2, it is recommended a few simple conditions:

Before the procedure, place the device on a flat surface. The surface can be rigid or have a soft lining of small thickness (medical couch, sofa). It is important that the surface where you place the unit does not bend more than 1-3 cm.
For the session to start, it is necessary to ensure good body contact with the electrodes. The device starts to work if the contact of the body with electrodes is more than 60%. For this need to be considered:
- Remove clothing before laying on the device, including the lumbosacral region and buttocks.
- Lying down on the machine must be such that the uppermost pair of electrodes be positioned in the middle of the neck and below the hairline.
Due to change positions of patient or changes of skin characteristics in the trigger zones during treatment, the skin contact area is decreased and it may be accompanied by disabling the program. Most of the programs have several phases under the influence of different zones. During a certain phase of the program in the target area, if electrodes are not in contact with the skin or are in the region of the pathologically changed area (trigger zone), the program may stop. For example, if a person is not completely freed lumbosacral zone from clothing, the implementation of programs B, C and D will be impossible if selected zone is chosen for stimulation. Stop the execution of the program due to the interruption of contact is normal and necessary for quality implementation procedures. For restart the program and restore contacts in full is recommended:
- Slightly bend your knees. This is particularly important when lumbar lordosis strongly expressed in the spine and the electrodes do not touch the body.
- Maximum free from clothing the impact area.
- Then restart the program.
- In case of repeated interruption of any of the programs (especially when the program is interrupted after 2-3 minutes or more from the start of treatment), should change the program and carry out 1-2 sessions using program C on neck and collar area and then continue course with the impact of other programs. After the end of the program, the device will emit a sound signal and stimulation will end. Also the device emits a signal when there is no contact of electrodes with skin for more than 5 seconds (less than 60% of contact group of selected zone).

Volume Setting: For convenience, you can set the volume of signaling. The device can work without sound or under two levels of volume of sound signals. Volume can be adjusted by pressing the volume buttons and (+) or (-). Under selection of volume of sound signals, use for switching on and increase of volume level simultaneous pressing of combination of buttons and (+), and for decreasing of volume or switching the sound off – simultaneous pressing of combination of buttons and (-). Volume is displayed on the device indicator, image is absent; (()))).

Switching Off the Device: Press and hold the power button until the device will be switched off.

After the End of Session: It is recommended to relax for 10-15 minutes.

Completion of Procedure: For switched off device, remove the napkin and treat the electrode surface of the unit of electrostimulation with a standard disinfectant (e.g. 3% solution of hydrogen peroxide). In case of serious dirt accumulation on the module, it is allowed to treat the device with a lint-free cloth, moistened with neutral and non-abrasive detergent.

Attention! Lack of adequate cleaning of elements can lead to the risk of allergic reactions or cross-colonization if the device is used by several people.
Attention! In case of idiosyncrasy, if during a session, there is a deterioration of health or after a session you feel skin irritation, it is necessary to stop treatment and consult a doctor immediately.
Attention! Under the appearance of any allergic reactions in the zone of contact of the device with skin, you should stop using the device and consult a doctor immediately.

Maintenance Features

Technical Maintenance and Order of Replacement of Batteries: Technical maintenance of the device should include the following procedures:

External examination of the product: You must make sure that there are no traces of blows and falls, because it can result in incorrect operation of the device.
Before using the device, and also after its use: It is necessary to clean the module of electrostimulation. Lack of adequate treatment may cause allergic reactions or infection of the skin if the device is used by several people. To clean it, use standard disinfectants (e.g. 3% solution of hydrogen peroxide) and soft, lint-free cloth.
If you intend not to use the device for a long period of time (more than 3 days), remove the batteries from the battery compartment. This will prevent their early discharge.
Under flashing of a symbol of battery status on the LCD display, you should replace batteries. To do this:
- Take off the cover of the battery compartment, as shown in fig. 6.
- Take off used batteries.
- Put new batteries, observing polarity.
- Fix the cover of the battery compartment back into its place.
Attention! Use only high-quality batteries! If you use defective batteries, there is a danger of spontaneous discharge of battery contents, as a result, the device may become unserviceable (not covered by manufacturer’s warranty), and there is a risk of chemical burn.

Troubleshooting List: This table lists conditions of the device which can be treated as malfunction and corrected independently. In case of other malfunctions, contact with a representative of the manufacturer (see section 11 «Manufacturer's warranty»), do not try to correct them by yourself.

Trouble	Possible reason	Method of elimination
The device does not switch on when you press the button	There are no batteries	Set new batteries (see section «Technical maintenance and order of replacement of batteries»)
	Voltage of batteries is less than 2.1 V	Change batteries (see section «Technical maintenance and order of replacement of batteries»)
Under switching on, the device emits sound signals and switches off automatically	Voltage of batteries is less than 2.1 V	Change batteries (see section «Technical maintenance and order of replacement of batteries»)
	Period of time between switching on of the device and its subsequent switching on is less than 3 seconds	Wait for 3 seconds after switching off the device and switch it on again
The device switches off or symbol of battery flashes and the device emits discontinuous signal	Voltage of batteries is less than 2.1 V	Set new batteries (see section «Technical maintenance and order of replacement of batteries»)
The device does not pass to mode of electrostimulation under contact of built-in electrodes with skin. There is no symbol of contact of the device with skin on LCD-indicator	Insufficient area of contact of electrode with skin	Make sure that no less than 60% of total number of electrodes in each zone of the device are tightly applied to the skin. Take off your underwear or apply the function "Therapy without contact" (see p.6.4.5)
During work, the device emits sound signal, shuts down the program and exits to menu
The device does not emit sound signals	Sound is switched off	Switch the sound on according to p.6.4.6
Quick consumption of batteries	Off grade batteries	Use high-quality batteries (alkaline batteries are recommended) or accumulators of corresponding unitsize with voltage of no more than 1.5 V

Manufacturer's Warranty:

The manufacturer guarantees the product requirements by TU 9444-013-44148620-2010, if the consumer observes conditions and rules of operation, storage, and transportation.
Operating time of the device: 5 years. Under observance of operation regulations, actual operating time can significantly exceed official.
Warranty period for the device: 12 months from the date of sale.
Warranty period for supplies (AC adaptor): 6 months from the date of sale.
The seller (manufacturer) or organization, which acts as a seller (manufacturer) on the basis of contract with it, is not responsible for the defaults should they occur after sale of the device as a result of:
1. Failure on the part of the consumer to comply with the rules of transportation, storage, care, and operation, provided by the present manual.
2. Mechanical damages.
3. Actions of the third party.
4. Force-majeure.
Guarantee obligations do not apply to products with broken manufacturer’s seal.
In case of unit breakdown or malfunction within the warranty period, as well as in case of incomplete shipping, the owner must send the following documents to the manufacturer’s address or manufacturers’ representative: claim for repair (exchange) with name, address, telephone number; defects list with brief description of the malfunction, date, and conditions of its appearance.