1. NAME OF THE DEVICE
RAVIMUSVET is an advanced veterinary wound dressing.

2. PRODUCT DESCRIPTION
RAVIMUSVET advanced veterinary wound dressing (RAVIMUSVET) is a sterile, single-use wound dressing intended for the treatment of veterinary wounds. Its wound contact layer is made of natural silk fibers with copper
and silver nanoparticles. The absorbent layer is composed of cellulose airlaid covered with LDPE (low density polyethylene). RAVIMUSVET dressing is designed to prevent growth of bacteria inside the wound dressing and to promote wound healing by providing a proper moist wound environment and by absorbing excess wound exudate.

3. MECHANISM OF ACTION
RAVIMUSVET serves as a physical barrier, preventing bacterial infiltration into the wound and thereby lowering the risk of infection. With the presence of copper and silver nanoparticles within the silk nanofibers at low concentrations, the dressing creates a localized bacteria-free environment, inhibiting the growth of a wide range of bacteria within its confines. Moreover, it creates a moist wound environment while absorbing excess exudates, which promotes natural wound healing and facilitates overall wound recovery. These combined features of the dressing might provide additional benefits of reducing bacterial colonization of the wound, thus mitigating the risk of infection without the potential drawbacks associated with topical antibiotics or antiseptics. Positioned as a promising solution for both acute and chronic wounds, RAVIMUSVET holds the potential to improve the quality of life for veterinary patients undergoing wound treatment. RAVIMUSVET does not contain any drug.

4. RAVIMUSVET INTENDED PURPOSE
RAVIMUSVETcan be used for the treatment of veterinary wounds.

5. DIRECTIONS FOR USE
Precautions to be taken before handling the medical device
• RAVIMUSVET may be used as part of a treatment regimen by a qualified veterinary professional or by veterinary patient’s caregiver.
• RAVIMUSVET is available in two formats: adhesive and non-adhesive.
  ◦ Adhesive format: The dressing has a self-adhesive border.
  ◦ Non-adhesive format: This version does not adhere by itself and must be covered with a suitable secondary dressing or bandage to keep it securely in place and to protect the wound.
• Clean the wound gently. Rinse the wound with wound-cleansing solution or water.
• Keep everything clean. Wash your hands carefully with soap and water before touching the wound or the dressing. It is recommended to use disposable gloves. Make sure the surface and tools are clean.
• Place the dressing on the wound so that it covers the wound completely. The beige side must be in contact with the wound. In the case of highly exudating wounds, apply a clean layer of padding on top of RAVIMUSVET before fixing the dressing in place.

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Opening the package and placing RAVIMUSVET on the wound
• Open the package containing the RAVIMUSVET gauze pad.
• Remove the gauze pad from the package. During this operation, ensure that the beige wound-contact side of the gauze pad (the side in contact with the transparent layer of the package) faces towards the operator.
• Do not touch the beige wound-contact side, especially with wet fingers, as the active component may detach from wound-contact layer.
• The dressing can be cut to appropriate size as needed.
• Place the gauze pad on the wound, ensuring that the beige wound-contact side is in contact with the wound.
• If necessary, apply a secondary dressing (bandage) to keep the RAVIMUSVET gauze pad securely in place.

6. WARNINGS AND PRECAUTIONS
• Sterility is guaranteed only if the package is opened immediately before use and the package is undamaged. Do not use if the primary packaging is damaged.
• Do not use the product in case the expiry date is exceeded.
• The product is for external use only. Do not swallow. Keep out of the sight and reach of children.
• The product is intended for single use only. Re-use may increase the risk of infection or cross-contamination, and may reduce the product’s effectiveness.
• When opening the packaging, a slight odour may occur. This is normal and related to the sterilization process of the product.
• Do not touch the beige wound contact layer of the dressing. The wound contact layer may peel off and stick to other surfaces, reducing the dressing’s effectiveness.
• During the normal healing process, the wound may appear larger at first. This is due to self-cleaning, where non-viable tissues are removed.
• The moist environment created by the dressing may support the growth of new blood vessels, which in some cases may cause bloody staining of the wound discharge.
• Appropriate supportive measures should be taken as indicated such as debridement, systemic antibiotic therapy, frequent wound monitoring etc.
• RAVIMUSVET is not intended for use as a surgical sponge.
• A veterinary patient’s caregiver must notify the veterinary doctor if:
  ◦ The wound becomes larger, deeper, or does not improve after 2–3 weeks of use.
  ◦ There are signs of infection such as increasing redness, swelling, warmth, pain, pus, or bad odour.
  ◦ Fever or chills develop.
  ◦ The wound bleeds heavily or bleeding does not stop.
  ◦ The dressing causes unexpected skin reaction (severe itching, burning, rash, or allergy).

7. UNDESIRABLE EFFECTS
There are no risks anticipated during the previous clinical and preclinical testing. Nevertheless, the following risks may appear:
• itching;
• allergy to wound dressing´s components;
If these or other side effects occur, please contact your veterinary doctor.
Any serious incident related to the device should be reported to the manufacturer.

8. HANDLING
RAVIMUSVET is a sterile single-use and disposable medical device for use under the instructions of veterinary professionals. It is mandatory to read the instructions before use.

9. STORAGE
RAVIMUSVET must be stored in its sealed, original packaging in a cool and dry place with a temperature ranging from 10 °C and 25 °C, away from heat and direct light. The expiration date applies to the product in its
intact packaging when stored as directed.
This device is not flammable. No special precautions for transport and storage are required.

10. DISPOSAL
Disposal of the RAVIMUSVET waste should be undertaken in accordance with local and national regulatory requirements for waste management concerning medical products.

11. MANUFACTURER
For more information, please contact Nanordica Medical OÜ:
Mäealuse 2/1, Tallinn 12618, Estonia

ravimus@nanordica.com
www.ravimus.com