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http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?lid=373789&lpcd=HCC
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The device for local combined therapy UNILOR-01 (var.2)
DESCRIPTION
The device can be used by medical staff and patient (by a doctor).
No special training and skills in the application of the device is required.
The device consists of:
• Power supply with built-in mains plug into it, in which the power cord switch integrated three-stage temperature control exposure and a connector for connection to a heating element and a radiator that can be implemented in a set or separately.
• Heating elements №1 to warm the nasal area.
• The heating element number 2 for warming the ear area.
• irradiator - source integrated exposure light pulse radiation and a magnetic field pulse with two nozzles
(one for the impact on the area of the nose, the other - on the area of the ear).
Indications for use:
ENT disease (stages of subacute and remission phase).
Indications "Unilor-01" of the device due to the presence of two products in the form factor
of the heating elements and radiator with nozzles.
Heat treatment - one of the oldest and most common methods of physical therapy effects
on the human body.
The main venue of the thermal effects of the application is the skin.
As a result of such exposure in the skin and adjacent tissue layers vary permeability barriers
and the activity of enzymatic processes.
The high efficiency of the procedures related to the fact that under the influence
of the thermal factor is the detection of changes in the body:
changing physical thermoregulation, respiration, tissue nutrition and metabolism
blood is redistributed
increased local temperature, and develops an active flushing of the skin
animated capillary blood flow and metabolic processes
Regional dynamics improved, resulting in a withdrawn and passive muscle stiffness
there is resorption of inflammation, scarring, adhesions
The main therapeutic effects of thermotherapy is considered to be:
- Anti-inflammatory,
- Trophico- regenerator,
- Antispastic,
- Vasodilator,
- Metabolic.
The heating elements to warm the nose and ears warm area due to its anatomical shape
provides a good fit to the heat affected zone, which ensures high efficiency of thermotherapy.
The use of pulsed light red (phototherapy) in physiotherapy is based on its main effects - as a result of energy absorption of the light pulse emission tissues red accelerated physicochemical reactions in the human body,
whereby the reduction processes are activated.
In tissues with active substances that stimulate thermoreceptors laid down in the skin,
mucous membranes and central nervous system, causing physiological responses of local and general.
The action in the light of pulsed radiation fabric red in the body and improves blood
circulation there is a change in vascular permeability, thereby reducing swelling, has a soothing effect,
while evident immunomodeliruyuschee action.
These physiological effects practically determine the list of the main indications for this
type of phototherapy:
• inflammation;
• reduction of metabolic processes;
• weak immunity,
• vascular spasm.
When phototherapy irradiator "UNILOR-01 'effectiveness
procedure is enhanced by the use of the combined effects of pulsed magnetic fields and pulsed
ight monochromatic radiation of red light range.
A magnetic induction coil mounted in the radiator.
The magnetic field improves the transparency of the medium,
thus increasing the depth of penetration of light radiation in biological tissue.
However, the impact of alternating magnetic field synchronized in time impulsive light irradiator that enhances therapeutic effect of the procedure.
It should be noted that the light pulse radiation of red range effectively
even in those cases where heat treatment is not shown:
in allergic rhinitis, and subacute stages of the inflammatory process.
The irradiator has two heads.
One of them is designed to act on the nose.
The second nozzle affects the area of the ear, it can be used even in the treatment of such diseases
in which the thermal treatment is contraindicated, such as acute suppurative otitis media
and furuncle of external auditory canal.
When changing the nozzle will automatically change the parameters of light effects:
the pulse repetition frequency and emission power.
This makes the impact of feed as effective as possible.
Main specifications:
3-step adjustment of the temperature at the working surface of the heating elements on air
(40 ± 5)? C, (47 ± 5)? C, (55 ± 5)? C
while setting the operating temperature of the heating elements
no more than 10 min
the average power of pulsed light radiation
a) for the nose - in the range from 4 W to 6;
b) for the ear - in the range of 2 to 3 mW;
the repetition frequency of the light pulses
a) for the nose - 870 Hz ± 10%;
b) Ear - 435 Hz ± 5%;
the maximum value of the pulsed magnetic field
not less than 5 mT;
the range of variation repetition frequency of the light pulses packs and bundles of magnetic field pulses
of (7 ± 2) to (13 ± 2) Hz;
duration of light emission, and magnetic effects
(5 ± 0,1) min
duration of continuous operation in intermittent mode
6 hours - (1 hour and 10 minute break.)
overall dimensions of the power source
not more than 95 x 85 x 65 mm;
Power supply weight
not more than 0.3 kg
supply voltage
220/230 V, 50 Hz
power consumption
not more than 8 · A
safety class
II BF
Product Options:
1) power supply, the heating element to warm up the nose, the heating element to warm the ear, the irradiator with nozzles set (5 pcs -for nose, 5-piece for the ear).
2) power supply, the heating element to warm up the nose, the heating element to warm the ear, the irradiator with a set of nozzles (3 pcs -for nose, 3-piece for the ear)
3) power supply, the heating element to warm up the nose, the heating element to warm the ear, the irradiator with nozzles set (5 pcs -for nose, 5-piece for the ear).
It is also possible the purchase of heating elements and nozzles separately.
Features:
- Safety applications, including children and pregnant women;
- Versatility of the device for the treatment of ENT diseases (including allergic rhinitis) due
to the presence of 2 heating elements and radiator with two nozzles;
- High therapeutic efficiency through the implementation of three types of physical therapy action
- the heat pulse light monochromatic radiation of red range and magnetic field;
- Specially selected pulse repetition frequency of the light
and magnetic radiation in the range of maximum sensitivity of human cells;
- Thanks to the implementation of the principle of frequency deviation
(variable burst repetition frequency) of the light and magnetic radiation in the range of 7-13 pacheksek provides high therapeutic effect;
- Heating elements for heating warm nose and ear region due to its anatomical shape
provide good adhesion to the heat affected zone, which increases the efficiency of thermotherapy;
- The device can be purchased in different models depending on the indication for use,
which allows the buyer to choose the heating elements, complementing the product of their choice;
as well as purchase them separately,
so as to complement the already available in his product (as standard);
- To comply with sanitary norms for the application of the device in different patients
in its configuration provides for a more replaceable nozzles for feed;
- Portability of the device provides ease of use, both in terms of ward and at home, on the road, at work.
The items will be shipped on second - third day after payment by registered priority airmail.
Delivery typically takes 10 to 14 days (about a week for Europe).
If you want to use other methods of shipment email to me.
ALL international buyers are Welcome!
The shipping is flat for all world:
FREE SHIPPING WORLDWIDE
WE WILL COMBINE MULTIPLE WINS TO SAVE ON SHIPPING
Guarantee of qualitative packing
30 days guarantee:
We guarantee you complete satisfaction with all my products.
If you receive an item you did not order or if an item you ordered is received damaged or defective.
We will refund you the price you paid for it or replace it with identical one. We accept returns in U.S.A.
Item for returning must have the original tags and packing, otherwise it won't be accepted.
Thanks and good luck!
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