TONUS ELAST 9512 Elastic medical bandage ribbon compressive/high stretch 80mmx3.0m

APPLICATION DATASHEET

MEDICAL ELASTIC BANDAGE

RIBBON, COMPRESSIVE

Model: ELAST 9512 H, ELAST 9512 M, ELAST 9512 L

Purpose: the elastic bandage is designed to prevent and treat varicose veins, as well as dislocations, sprains, oedema and other traumatic complications.

Medical indication

In the treatment of various diseases:

• (ELAST 9512 H) high stretch bandage: for the treatment of lipedema diseases, during surgery, and in cases of trauma and incurable lymphedema (in the relevant tissues).
• (ELAST 9512 M) medium stretch bandage: for the treatment of severe varicose veins and related trophic ulcers, as well as syndrome accompanying phlebitis (inflammation of the veins) and lymphedema (in the relevant tissues).
• (ELAST 9512 L) low stretch bandage:  for bandage fixation.

Before and after surgery: for faster rehabilitation after injuries and surgeries, prevention of edema and reduction of inflammatory processes.

For prevention purposes: to avoid overload and overwork during exercise; for the prevention of sprains and other injuries during sports activities.

Composition of raw materials: 

• high stretch bandage (ELAST 9512 H):  cotton –  80%, polyester– 15%, latex– 5%.
• medium stretch bandage (ELAST 9512 M):  cotton – 58%, latex – 22%, polyester – 20%.
• low stretch bandage (ELAST 9512 L): cotton – 53%, latex – 29%, polyester – 18%.

Intended users/Patient target group: adults with complaints corresponding to the medical indications of the product, as well as healthcare professionals applying the device to patients with corresponding complaints and indications. The device can be used at home, for sport, at medical and other healthcare facilities. Intended user must choose the appropriate size, considering the necessary functions/indications, the manufacturer's information or instructions from the healthcare professional.

Method of application (1): The width of the bandage should preferably be equal to or greater than the diameter of the body part to be bandaged. Before bandaging, it is recommended to lie down with your legs up for 5-10 minutes. Leave the bandaged leg up. Bandage the foot from the ankle to the base of the toes, then bandage the lower leg and thigh, going upwards. Bandage is to be applied so that each next layer of bandage covers the previous one by 50-70%. Apply the bandage most tightly around the ankle, and then, towards the thigh, apply it looser. The heel should be bandaged, forming the so-called "eight" so that when walking the bandage does not slip off the leg. Finish bandaging by placing the last wrap 5-10 cm above the area affected by varicose veins; fix the end of the bandage with a clip.

Method of application (2): When bandaging: wrap the bandage around the arm, starting from the inside of the palm, then continue bandaging diagonally down, along the dorsal surface of the hand - between the thumb and forefinger, then across the hand and wrap back to the base of the hand. Wrap the bandage around the base of the hand, and then bandage further down, across the palm, then around the outside of the hand, between the thumb and forefinger, and again towards the palm. Then wrap around the base of the palm. After that, a second full bandaging should be done - in the form of a so-called "eight"; wrap the base of the wrist and continue bandaging up the arm, half covering the previous layer with the next one. At the base of the arm, the bandage should be secured with a clip.

Warning!

Bandaging should not be done too loosely, so that the bandage could slip off the bandaged part of the body, and at the same time, the bandaging should not be too tight. If your fingers start to tingle, if there is a pulsing sensation in your fingers or under the bandage, or pain occurs, this means that you have chosen the wrong degree of compression or bandaged incorrectly.

Best before – 5 years from the date of manufacture.

Contraindications: none known at present.

Risks / Side Effects: individual incompatibility with components of raw materials of the product.

Sanitary-and-hygienic processing: we recommend washing by hand in a soap solution at a temperature of + 40 °C without the use of bleaches. Do not use chemical agents for cleaning. It is recommended to gently squeeze out the water without wringing and dry the product in a spread manner. Do not iron.

Storage: The product is to be stored in a clean, dry and ventilated place at a temperature of +3°C to +30°C.

Packing: 1 piece

Disposal: once you have finished using the product, please dispose of it according to local specifications.

Important notes: this medical device is made for single patient use only. If it is used for treating more than one patient, the manufacturer's product liability will become invalid. If undue pain or an unpleasant sensation develops while you are wearing the product, please consult your doctor or orthotist immediately. Do not wear the product over open wounds, and use it only as instructed by your doctor or orthotist.

Warnings / Precautions: in the event of any complaints regarding the product such as damage to the fabric or a fault in the fit, please report to your specialist medical retailer directly. Only serious incidents which could lead to a significant deterioration in health or death are to be reported to the manufacturer or the relevant authorities in an EU member state. The criteria for serious incidents are defined in Section 2, No. 65 of Regulation (EU) 2017/745 (MDR).

The manufacturer: TONUS ELAST SIA, "Pilskalni", Grinvalti, Nicas pag., Dienvidkurzemes nov., LV-3473, Latvia.

The Instruction was last reviewed – 2023-03.

Do not throw away the instructions before the expiration date of the product!