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Instruction for Use of Indididual Paraffin-Containing Therapeutic Belt NEPHROMED

1. Purpose
            Nephromed belt is used for therapy and prophylaxis of chronic renal diseases (urolithiasis, chronic pyelonephritis, and dysmetabolic nephropathy), complications of distance hit-wave lithotripsy and chronic inflammatory (radiculitis, radiculosciatica, and lumbago) and degenerative (osteochondrosis) lumbar diseases.
            Mechanism of action of excludes external heat and beneficial effects and is due to its influence on pathological processes in the kidney and spinal cord exerted by paraffin-containing inserts which are the main component of Nephromed belt. These medical inserts effect the projection zones of the kidney and lumbar spine thus activating microcirculation, nutrition, and cellular metabolism in the tissues and decreasing spastic and edema components, relieving pain, suppressing inflammation and stagnation in the kidney, tissues of vertebral joints, and paravertebral muscles as well as gradually loosening and inducing complete evacuation of kidney stones as tiny fragments. This normalizes blood flow and innervation restoring function of damaged organs and improving self-evaluation and quality of life of patients.

2. Indications
- urolithiasis (regardless of chemical composition, size, and density of renal stones)
- chronic pyelonephritis
- complications of distance hit-wave lithotripsy
- dysmetabolic nephropathy
- lumbar osteochondrosis
- radiculitis
- radiculosciatica
- lumbago

3. Instructions for use
a) Open the polyethylene package
b) Take out the belt and fasten it so that the medical paraffin-containing inserts are fixed in the lumbar area to the left and to the right of the spine (see Fig.).

Fig. 1   Fig. 2

Paraffin-containing Nephromed belt can be applied directly to the skin or can be used through underwear without tightening. Size of the belt corresponds to the waist circumference in centimeters (table of sizes is shown on the package).
            Nephromed belt should be used continuously preferably for 24 hours; the regimen might influence duration and efficacy of treatment.
            Short breaks in therapy can be allowed in order to:
- clean or wash the holder of the belt;
- swimming in a pool or other reservoir, other water and hygiene procedures;
- discomfort while sleeping or during active physical load (fitness machines, biking, long walks, running, etc.).
            Nephromed belt should be applied again immediately after the break so that beneficial effect does not disappear.
Possible changes in shape or integrity of paraffin inserts have no negative influence of their therapeutic activity.
The Nephromed belt is designed for individual use and should not be shared with other people.
It cannot be returned of exchanged.

4. Duration of the treatment.
In urolithiasis:
Duration of treatment cycle depends on individual parameters of the patient, history and severity of pathology, and size and density of the kidney stones.
In case of small size and loose density kidney stones, beneficial effect is usually detected in 3-6 months on average. First signs of progress appear in 2-4 weeks and are associated with improved self-evaluation and complete or partial suppression of pain; in some patients, amount of urine can be increased and color or clearness of urine can be changed; sometimes, urination can be associated with moderate sensation of burning or pain.
Subsequent treatment with Nephromed belt significantly improves the results of clinical and laboratory tests and of ultrasound imaging. Examination of patients reveals substantial decrease in size and number of baseline concretions while their density is loosened and chronic inflammation of renal parenchyma is diminished.
            In complicated disease (chronic pyelonephritis, large and multiple stones, signs of chronic renal failure), Nephromed belt should be used for 9 or more months. Treatment normalizes renal circulation and helps to loosen renal stones which crumble and are painlessly secreted with urinary flow as tiny fragments. Kidney function is restored and self-evaluation and quality of life are improved.
Continuous treatment can be performed during the whole shelf life of the Nephromed belt as indicated on its package.
            Nephromed belt is highly effective in patients after distance hit-wave lithotripsy. Lithotripsy can be associated with posttraumatic complications (sites of hemorrhage and inflammation) in renal parenchyma and sometimes hit-wave lithotripsy results in incomplete excretion of the stone fragments and high probability of severe pain during their evacuation; use of belt prevents further lesions in renal blood flow and spreading of the inflammation and assists in complete destruction and less painful evacuation of the remains of the stones from the kidney.
For prophylaxis, Nephromed belt can be used for short periods of time during the whole shelf life of the belt or for 2-3 weeks every 3 months; this will significantly decrease the risk of complications and exacerbation of the disease and efficiently prevent secondary stone formation.
In lumbar osteochondrosis:
Duration of treatment is individual for each patient.
Recommended minimal period of continuous treatment is 3 months; in most patients, first stages (2-4 weeks) substantially improve self-evaluation, arrest or significantly decrease pain, tension, and constraint of the muscles, restore elasticity of the muscle fibers, tendons, and ligaments, improve amortization of intervertebral discs, abolish compression of the roots of the spinal nerves, restore circulation and innervation of the tissues, strengthen muscular corset, and enhance and completely normalize mobility of the patients.
Persistent therapeutic effect requires understanding that pain-relieving effect is only the first stage of the treatment and treatment should not be discontinued after acute symptoms had ceased. Long-term treatment for 6 or more months significantly inhibits progression of the disease, activates microcirculation, nutrition, and tissue metabolism of the muscles and intervertebral joints thus restoring their structure and function.
Treatment with Nephromed belt excludes side effects on other organs and tissues and can be administered for therapy and prophylaxis in case of acute symptoms for the whole duration of its shelf life up to expiration date.
Maximal period of device use:
For treatment purposes: 2 years beginning from the treatment commencement though not exceeding the date “Use before…”, pointed on the cardboard wrapper.
For prophylactic purposes: until the date “Use before…”, pointed on the cardboard wrapper.
            Nephromed belt is well tolerated, safe, and compatible with other medications and has no side effects; thus, it can be used in patients of all ages as prescribed by physician.
            Nephromed belt can be used as monotherapy or in combination with any other types of therapy. Combined therapy can potentiate the effects of other medications thus decreasing their required dose or duration of administration.
It is recommended that treatment should be prescribed after clinical examination and that the patients should regularly consult his physician.

5. Care
Hand washing is recommended; paraffin-containing inserts should be taken out and placed in the dark at room temperature. The carrier part of the belt should not be presoaked and can be washed in warm water (no more than 40 degrees centigrade). After drying, medical inserts should be reloaded into the pockets of the belt for subsequent use. 

6. Storage
Nephromed belt should be stored at room temperature in the dark. It is strictly prohibited to store and use the Nephromed belt in the vicinity of heat sources and corrosive chemicals.
Expiration date: see package.

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