Opis
Neurodyn Evolution Description
NEURODYN EVOLUTION has been designed according to existing technical standards for the construction of medical devices (NBR NBR IEC 60601-1 and IEC 60601-2-10). This is a device that uses microcomputer technology, i.e. it is micro controlled. NEURODYN EVOLUTION is a complete unit of electrical stimulation and biofeedback perineal manometrical of simple operation, computerized or not computerized, with an output channel, allowing multiple treatment options, making it essential to uro-gynecologic or colorectal proctological of high quality treatment. It is a device for the low-frequency electrotherapy modes (same band of frequencies used in the stimulation TENS and FES).
When a person is submitted to electrical stimulation, she or he will feel a tingling sensation at the site of stimulation or in the areas around the electrodes. This sensation is generally comfortable for most of these people. This sensation is controlled by adjusting the parameters (control) of the equipment.
Regarding biofeedback, the patient must undergo perineal contractions, where the equipment will provide visual information about the intensity which they can be made. In this way computerized information appear on the computer screen, and the non-computerized mode, in a bargraphic tower (colored light bar) which is an accessory of the equipment. Thus, both the forces of the perineal contractions and the suggestions provided by the equipment can be viewed.
Because of the technology used is the same as microcomputers, these controls operate through touching the keyboards of the device ( no computerized mode) or computer keyboard and mouse (computer mode). All information related to parameters chosen by the professional will be displayed in the alphanumeric LCD, when in the non- computerized mode of operation, or on the computer screen, when in the computerized mode.
NEURODYN EVOLUTION permits the choice of the following stimulation parameters for the computerized and non-computerized operation modes:
Waveform – Rectangular Pulses, Biphasic, Symmetric, Balanced;
Maximum Current Intensity – 80 mA peak to a load of 1 kΩ (in output mode power supply);
Intensity Control: – UP and DOWN buttons located on the panel of the equipment;
Timer – allows you to select application time from 1 to 60 minutes (step 1 minute). At the end of selected time, an alarm will sound and the passing current to the patient will be ceased. The selected value will decrease as this time is running out;
R (repetition frequency of pulses): – Variable from 1 Hz to 150 Hz in steps of 5 Hz;
T (pulse duration): – variable from 100 us to 1000 us in steps of 50 us. After this, it generates another pulse with similar duration and effect of reverse polarity to balance the electrical charges in the tissues.
RISE (rising ramp pulse): – Pulse rising time, variable 0-10 seconds (step 1 second). It regulates the speed of contraction, i.e. the time from the beginning until the maximum muscle contraction. High time produces a slow and gradual contraction. Low time produces a more sudden, small contraction (sudden).
DECAY (ramp-down pulse) – Pulse lowering time, variable 0-10 seconds (step 1 second). It regulates the speed at which the contraction decreases, i.e. the time from maximum contraction before the muscle relaxation. High time produces a slow relaxation. Low time produces a sudden relaxation (sudden).
ON TIME (time on): – time of maximum muscle contraction, variable 0-30 seconds (step 1 second). It adjusts the time that the current flows through the electrodes during each cycle of stimulation.
OFF TIME (time off): – resting time of muscle contraction, variable 0-30 seconds (step 1 second). It adjusts the time that no current flows through the electrodes during each cycle.
Regarding the parameters of biofeedback, NEURODYN EVOLUTION latex vaginal or anal probe has a fixed system to set the level of internal pressure. So when the power is turned on, the volume of air inside the probe should be adjusted through a 60 ml syringe. In this event, a light signal will rise indicating that the internal pressure of the probe has reached the standard level. After pressing the READY button, the unit is ready to be used. This standardization of adjustment can be very useful for scientific purposes in terms of comparison of perineal contraction between different groups of patients.
Note: After pressing the READY button, the unit will continue its operation no matter the correct adjustment of the latex vaginal or the anal probe.
For the non- computerized mode the operation, the bargraph tower is able to provide the following parameters of manometric perineal biofeedback with an application time from 1-60 min (step 1 minute) (with countdown timer):
– 1-5 peaks (step 1 peak) over a period of time 10-10 sec (step 1 second) followed by a resting period less than 10 or 20% over a period of time from 1 to 20 sec (step of 1 second).
– Isometric work from 30 to 95% (step of 5%) followed by a resting period of less than 10 or 20% over a period of time from 1 to 60 sec.
In the computerized operating mode, the device enables the following settings of biofeedback:
– Tonic contraction 90% – 10s
– Tonic contraction 75% – 6s
– Tonic contraction 50% – 6s
– Relaxation 10% – 3s
– Relaxation 10% – 5s
– Relaxation 10% – 10s
– Relaxation 10% – 15s
– Relaxation 10% – 20s
– Relaxation 20% – 3s
– Relaxation 20% – 5s
– Relaxation 20% – 10s
– Relaxation 20% – 15s
– Relaxation 20% – 20s
– Relaxation 20% – 30s
– Relaxation 20% – 60s
– Relaxation 30% – 5s
– Relaxation 30% – 10s
– Relaxation 30% – 15s
– Relaxation 30% – 120s
– Free work – 3s
– Free work – 6s
– Free work – 10s
– Work up to 25% – 3s
– Work up to 100% – 10s
– Isometric work at 25% – 6s
– Isometric work at 25% – 10s
– Isometric work at 25% – 60s
– Isometric work 40% – 5s
– Isometric work 40% – 15s
– Isometric work 40% – 20s
– Isometric work 40% – 30s
– Isometric work to 50% – 6s
– Isometric work at 50% – 10s
– Isometric work at 75% – 6s
– Isometric work at 75% – 10s
– Isometric work at 85% – 10s
– Isometric work at 85% – 20s
– Isometric work at 95% – 10s
– Prolonged isometric work – 20s
– Eccentric work up / down – 95% – 10s
– Eccentric work up / down – 75% – 10s
– Eccentric work up / down – 50% – 10s
– Free work 75-10% – 5s
– Free work 75-10% – 15s
– Free work – 60s
– Concentric work – endurance – 6s
– Concentric work – Endurance – 10s
– 5 peaks in 40% 10s
– 5 peaks in 60% 10s
– 5 peaks in 90% 10s
– 3 peaks in 40% 10s
– 3 peaks in 60% 10s
– 3 peaks in 90% 10s
– 2 peaks in 40% 5s
– 2 peaks in 60% 5s
– 2 peaks in 90% 5s
– Uniform phasic contractions 60% 10s
– Uniform phasic contractions 80% 10s
– Uniform phasic contractions 60% 5s
– Uniform phasic contractions 80% 5s
– Non-uniform phasic contractions 80% 50% 5s
– non-uniform phasic contractions 80% 50% 10s
– Concentric work 60% 6s
– Concentric work 100% 6s
– Concentric work 60% 10s
– Concentric work 100% 10s
– Active contractions 90% 10s
– Active contractions 60% 10s
– Tonic alternating contractions 90% 10s
– Tonic alternating contractions 60% 10s
– 2 functional peaks 90% 10s
– 2 functional peaks 60% 10s
– 5 functional peaks 90% 20s
In the computerized mode, NEURODYN EVOLUTION software still provides the following options:
Create and Run Treatment Programs : – With a duration between 1 and 60 minutes, therapeutic sequences (modules) can be created ranging from electrical stimulation and biofeedback with distinct parameters, according to the programmer’s wish. The only parameter to be adjusted during application is the amplitude of the electrical current.
Note: Caution should be taken to adjust the amplitude of electric current, because if there is a significant increase in frequency or pulse width in a transition between two modules of electrical stimulation, the energy provided in the tissue will rise abruptly which may cause undesirable sensations to the patient.
Assessment: – The software of NEURODYN EVOLUTION has a database that stores important information related to the treatment of the patients.
Storage of the sessions: – In NEURODYN EVOLUTION, you can check in a personalized way all therapeutic parameters applied with the date of the session, both for the programs created and for the parameters used in isolation (electrical stimulation or biofeedback).
Information Menu: – In this part of the software, important information regarding the operation of NEURODYN EVOLUTION, recommendations for the safety of clinical practice as well as suggestions for their improvement can be found.
PRODUCT FEATURES
NEURODYN EVOLUTION is an equipment designed for continuous operation mode. It is not protected from harmful water penetration (IPX0). It uses microcontrolled technology to ensure the accuracy of the values shown. The accuracy of operation is in accordance with the standards for particular safety equipment for neuromuscular stimulation – NBR IEC 60601-2-10, Clause 50 / subclauses 50.1 and 50.2. The amplitude control continuously monitors the output current intensity from the minimum to the maximum and the minimum value does not exceed 2% of the maximum position. The parameters such as waveform output, pulse duration, pulse repetition frequency, amplitude range of output current do not differ by more than + / -30% mentioned in the following technical description.
The values of the durations of pulses and pulse repetition frequency described here were measured at 50% of the maximum amplitude of the output. These parameters are for a range of load impedance of 820-1200 ohms. The effect of load impedance parameters described is very important. If the appliance operates outside the specified load impedance range , there may be inaccuracy in the values of the parameters, as well as modification of the waveforms described here.
The Neurodyn Evolution is a Class II single-phase equipment with Type BF applied part of security and protection.
Power source: – Bivolt 110/240 V ~ (60 Hz);
Input Power – Consumption (Max): – 30 Va;
Fuse network protection: – 500 mA (20AG);
Output channels:– one channel for electrical stimulation (single channel) and a channel for manometric perineal biofeedback:
Timer: – Variable from 1 to 60 minutes (steps of 1 min.) with the countdown.
Dimensions (mm): – 360 x 300 x 115 (W x D x H);
Weight (approx. without accessories): – 0.5 kg;
Stacking up: – 5 boxes;
Environmental conditions for storage and transportation: – Limit of moisture for transportation – 30% to 90%;
Temperature for transportation – 5-50 ° C;
Environment operating temperature: – 5-45 ° C.
Electrical stimulation parameters (for computerized and non- computerized modes of operation ):
Amplitude Range – 80 mA peak;
Pulse format: – balanced biphasic symmetric rectangular wave;
Length (w – T) of a positive pulse current 50% of maximum amplitude: – Variable from100 us to 1000 us (steps of 50 us);
Range Pulse Repetition Frequency (R) 50% of maximum amplitude: – variable from 1 Hz to 150 Hz (5 Hz steps);
ON Time: – Variable 1-30 seconds (1 second steps);
OFF Time: – Variable 1-30 seconds (1 second steps);
RISE (Rising time of the pulse train): – Variable 1-10 seconds (1 second steps);
DECAY ( decay time of the pulse train): – Variable 1-10 seconds (1 second steps).
Biofeedback Parameters :
Non- computerized mode of operation:
– 1-5 spikes from 1 to 10 sec followed by a resting period of less than 10 or 20% over a period of time from 1 to 20 seconds;
– Isometric work from 30 to 95% followed by a resting period of less than 10 or 20% over a period of time from 1 to 20 seconds.
Computerized operating mode:
– Tonic contraction of 90% – 10s
– Tonic contraction of 75% – 6s
– Tonic contraction of 50% – 6s
– Relaxation 10% – 3s
– Relaxation 10% – 5s
– Relaxation 10% – 10s
– Relaxation 10% – 15s
– Relaxation 10% – 20s
– Relaxation 20% – 3s
– Relaxation 20% – 5s
– Relaxation 20% – 10s
– Relaxation 20% – 15s
– Relaxation 20% – 20s
– Relaxation 20% – 30s
– Relaxation 20% – 60s
– Relaxation 30% – 5s
– Relaxation 30% – 10s
– Relaxation 30% – 15s
– Relaxation 30% – 120s
– Free work – 3s
– Free work – 6s
– Free work – 10s
– Work up to 25% – 3s
– Work up to 100% – 10s
– Isometric work at 25% – 6s
– Isometric work at 25% – 10s
– Isometric work at 25% – 60s
– Isometric work 40% – 5s
– Isometric work 40% – 15s
– Isometric work 40% – 20s
– Isometric work 40% – 30s
– Isometric work at 50% – 6s
– Isometric work at 50% – 10s
– Isometric work at 75% – 6s
– Isometric work at 75% – 10s
– Isometric work at 85% – 10s
– Isometric work at 85% – 20s
– Isometric work at 95% – 10s
– Prolonged isometric work – 20s
– Eccentric work up / down – 95% – 10s
– Eccentric work up / down – 75% – 10s
– Eccentric work up / down – 50% – 10s
– Free work 75-10% – 5s
– Free work 75-10% – 15s
– Free work – 60s
– Concentric work – endurance – 6s
– Concentric work – endurance – 10s
– 5 peaks in 10s 40%
– 5 peaks in 10s 60%
– 5 peaks in 10s 90%
– 3 peaks at 40% 10s
– 3 peaks at 60% 10s
– 3 peaks at 90% 10s
– 2 peaks at 40% 5s
– 2 peaks at 60% 5s
– 2 peaks at 90% 5s
– Uniform phasic contractions 60% 10s
– Uniform phasic contractions 80% 10s
– Uniform phasic contractions 60% 5s
– Uniform phasic contractions 80% 5s
– Non-uniform phasic contractions 80% 50% 5s
– Non -uniform phasic contractions 80% 50% 10s
– ConcentricWork 60% 6s
– Concentric work 100% 6s
– Concentric work 60% 10s
– Concentric work 100% 10s
– Active contractions 90% 10s
– Active contractions 60% 10s
– Alternated tonic contractions 90% 10s
– Alternated tonic contractions 60% 10s
– 2 functional peaks 90% 10s
– 2 functional peaks 60% 10s
– 5 functional peaks 90% 20s
– 5 functional peaks 60% 20s
Abbreviations of measurement units used:
mA = milliamperes;
Hz = hertz;
Va = volt amps;
mm = mm;
usec = us = microseconds;
s = seconds;
msec = milliseconds.
V ~ = AC voltage;
cm = centimeter;
W = watts;
Ω = ohms.
Accessories accompanying the appliance:
– 01 pair of silicone rubber electrode 50 x 50 mm;
– 01 detachable power cable;
– 01 cable for stimulation (blue);
– 01 latex vaginal probe;
– 01 latex anal probe;
– 01 teflon vaginal probe;
– 01 teflon small vaginal probe,;
– 01 60 ml syringe;
– 01 opening tap / closing pressure;
– 01 bargraphic tower
– 01 cable for serial communication with the microcomputer;
– 02 crystal hoses 1.5 m;
– 01 CD-ROM with manual and software installation for operation with computer.
Ps: Using cables, electrodes and other accessories different from those specified above may result in increased emissions or decreased immunity of equipment.
Note: The device and its features may change without previous notice.
