Intended use:

_To improve leg mobility, leg muscle stretching, help to support leg muscle tissue, soothe leg pain while starting to move legs again after a long inactivity period.

MD-ISCHIAL is a medical device finalized to help movement by limiting a physiological degeneration of joints and tissues as well as by counterbalancing any damage caused by:

aging
bad posture
concomitant chronic diseases
blows and injuries
pollutants

MD-ISCHIAL is a medical device finalized to help movement, specifically the low back area of the vertebral spine. Its main therapeutic functions include:

a barrier effect
a lubricating activity
a mechanical support while administering other pharmacological treatments

MD-ISCHIAL is a medical device intended to be used by a qualified staff in private or public health facilities.

Direction for use

Treatment protocol:

1 treatment a week for 10 weeks.

Periarticular technique: (the site of application must be sterile; insert the needle near the sacroiliac joint at 2-4 mm depth).

For this purpose the use of the following materials and accessories is recommended;

Materials for aseptic skin preparation: sterile gloves, Iodine solution, Alcohol solution, sterile gauze pads, Ethyl chloride spray for the skin.
Needles: sterile 27 G.
Syringes: 5 or 10 cc size, according to the volume of the solution to inject.

Contraindications / Side effects

There is no history of hypersensitivity to MD-ISCHIAL. However, patients with a recognized hypersensitivity to any ingredient or excipient should be tested before use, making a spot into one arm and be monitored for 1 hour.

Performance

MD-ISCHIAL may be used as a single treatment or mixed with other medical devices of the same range, in order to make a customized treatment according to clinical evolution.

When a supportive treatment is needed for acute pain, MD-ISCHIAL can be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (together with one or more than one of these).

Moreover, when a supportive treatment is needed for the connective tissue matrix or when the physiological aging process should be slowed down, MD-ISCHIAL can be associated with MD-MATRIX and MD-TISSUE.

It may also be used as a mechanical support while treating the following diseases:

Sciatica pain
Lumbar-sciatic pain

(in association with MD-LUMBAR and MD-NEURAL)

Nerve pain in the lower lumbar spine

(in association with MD-MUSCLE)

Leg nerve pain due to post-surgery treatment of disc herniation L4-L5, L5-S1
Morton neuroma (in association with MD-NEURAL).

Instructions in case of damage to the sterile vials / ampoules

Do not use if the seal is open or if the vial/ampoule is not perfectly sealed.

Once open, the vial/ampoule must be immediately injected.

Do not use if the package is damaged.

Warnings and precautions

Sciatic pain requires differential diagnosis for secondary muscle pain, full-blown disc herniation, vertebral canal stenosis, Cauda equine syndrome.

A slight reddening at the site may be due to a mechanical effect of the needle or to a skin superficial reaction.

Skin cleansing/disinfection is required before and after application. Saprophytic bacteria may produce site abscesses. KEEP AWAY FROM THE REACH AND THE SIGHT OF CHILDREN.

Do not use after the expiration date. The expiration date refers to the product property stored in an unopened package. Use the product immediately after opening the package.