INSTRUCTION FOR USE OF MEDICAL DEVICE

Hemostatic dressing material REVUL®

Description

Hemostatic dressing material REVUL^® is a highly effective hemostatic agent made of natural chitosan designed to stop various types of bleeding. REVUL^® works independently of the blood clotting processes in the body. Haemostatic effect is associated with binding of positively charged elements of the medical device with negatively charged red blood cells. When contacted with blood, REVUL^® facilitates absorption of the blood liquids and forms a single gel/jelly-like mass, which helps to stop bleeding.

Contents of packaging

Zigzag folded chitosan bandage.

Dimensions: 11.2 cm × 1.83 m.

Composition: chitosan (non-woven natural material).

Indications

It is intended to stop external bleeding of varying intensity, including when large venous and arterial vessels are damaged, mostly at the pre-hospital stage.

Contraindications

Hypersensitivity to chitosan.

Method of administration

1. Check the shelf-life and packaging integrity of the medical device.
2. Open the REVUL^®
3. Tap the wound dry with REVUL^® bandage at the source of bleeding. DO NOT THROW AWAY THE EMPTY BAG!
4. Press a bandage or gauze sponge tightly to the wound for 5 minutes. If the bleeding persists, hold for another 5 minutes.
5. Apply a pressure bandage to the wound.
6. Transport the victim to the nearest first-aid-station as soon as possible.
7. Pass the empty bag to healthcare professionals.
8. Do not use any remaining bandage.

CAUTION! Hemostatic dressing material REVUL^® can remain in the wound for a day. The formed clot does not disintegrate and does not change its properties. After 24 hours, chitosan granules break down into polysaccharides and are naturally eliminated from the body.

Adverse reactions

Hypersensitivity reactions.

Warnings and precautions for use

• Disposable sterile medical device.
• Open the packaging immediately before use; do not reuse.
• Do not use expired product.
• Do not use the product if the primary packaging is damaged.
• For external use only.

Shelf life: 2 years.

Storage conditions

Keep out of reach of children at +5 °C to +30 °C.

Name and address of manufacturer

Yuria-pharm LLC, 10, M. Amosova Str., Kyiv, Ukraine, 03038.
Tel.: +38 (044) 275-92-42, +38 (044) 275-01-08.
E-mail: uf@uf.ua
www.uf.ua
www.revul.com.ua

Manufacturing site address: 21/13, Chygyrynska Str., Cherkasy, Ukraine, 18030.

Date of last revision of instructions for use: 04.04.2022.

Version: 05.