PHOVIA Topical photoconverter gel (Canada)

Company: Vetoquinol

To be used with PHOVIA LED Lamp for delivery of Fluorescent Light Energy

Instructions For Use

For Veterinary Use Only

1. Device Description

The PHOVIA System is composed of two products: the PHOVIA LED Lamp, and the PHOVIA Gel. The PHOVIA Gel is a topical gel containing chromophores. It is used with the PHOVIA LED Lamp that delivers non-coherent blue light. When PHOVIA Gel is illuminated by the PHOVIA LED Lamp as per instructions, it emits Fluorescent Light Energy. The PHOVIA Gel is presented in two containers, a jar and an ampule. The contents of both containers must be mixed together, in the jar, immediately before application.

Please read this document in conjunction with the PHOVIA LED Lamp instructions prior to use.

2. Use

The PHOVIA System is for topical application and is intended to create an environment supporting the skin’s own regeneration mechanisms in a physical way.

3. Warnings

Do not use if the animal:

a) is known to have photosensitivity as a result of a medical condition or is taking medicines / products known to induce photosensitivity reactions;

b) has a known skin hypersensitivity;

c) has a known porphyria condition.

4. Precautions

● This product has not been tested in pregnant or lactating animals. The veterinarian should apply a risk-benefit judgment when considering using the product.

● Before using the PHOVIA Gel, it is important to read and understand the instructions for use, warnings, precautions, potential complications/adverse reactions and the use of the PHOVIA System.

● Do not use if the product appears damaged, if the carrier gel jar is not translucent, or if ampule gel is colourless.

● The gels are light sensitive. Keep unused ampules inside the protective foil pouch and keep the pouch and the jars in the original box and protected from light.

● The PHOVIA Gel should be kept away from open flames and excessive heat. The PHOVIA Gel should be kept between 2°C and 25°C. Temperature excursions down to -20°C or up to 30°C are allowed for a maximum of 48 hours.

● Each PHOVIA Gel application (1 jar and 1 ampule) is for single use. Do not use more than once.

● Avoid looking at the PHOVIA LED Lamp without eye protection when in use. Suitable blue filtering safety goggles are supplied with the lamp and must be worn by anyone in the room that might be exposed to the light, such as the veterinarian, the assistant or the animal owner during illumination. The animal’s head should be facing away from the lamp or the animal’s eyes should be covered to avoid the animal looking directly at the lamp when in use.

● Signs of local infection should be treated as per the clinician’s standard of care protocol.

● The PHOVIA System should be used by a trained veterinarian or, in accordance with local legislation, a suitably trained clinic staff member working under the veterinarian’s supervision.

5. Potential Complications

Fluorescence Light Energy is generally safe and well tolerated but in rare instances, adverse events may occur. Adverse events that can be associated with Fluorescence Light Energy in general are agitation, burning, dry/itchy skin, erythema, hyperactivity, irritability, edema or worsening of skin diseases.

Potential complications and adverse events associated with the PHOVIA System are: hair colour change, erythema that regresses within 6-12 hours, skin hyperpigmentation, pain and burning sensation at the targeted site, and fatigue.

6. Product Specifications

Each PHOVIA Gel application is for single use only and is supplied as a jar (20 g) containing the clear carrier gel and an ampule (2.0 g) containing the orange coloured chromophore gel which should be mixed together (see section 7. Directions for use). This PHOVIA Kit box contains materials for five (5) PHOVIA Gel applications.

7. Directions for Use

Always use in conjunction with the PHOVIA LED Lamp Instructions for Use.

Mixing Instructions and PHOVIA Gel application procedure: PHOVIA Gel should be prepared and applied in a clean environment.

1. Remove the contents from the PHOVIA Kit box: 1 ampule, 1 jar and 1 mixing spatula. Place the remaining ampules back inside the foil pouch and the pouch inside the box, protected from light.

2. Put gloves on.

3. Remove the lid from the jar and the tip of the ampule.

4. Transfer the contents of the ampule into the jar.

5. Use the supplied spatula, then mix well until orange colour is uniform.

6. Close the jar until ready for application.

7. Remove any dressings that may be on the animal.

8. If applicable, gently clip any hair that prevents full contact of the PHOVIA Gel with the surface of the skin.

9. Clean the skin with sterile saline solution if needed. Should a different solution or product be used for cleaning the skin, please ensure that you rinse the skin with sterile saline solution after use.

10. Prepare the PHOVIA LED Lamp, as per its instructions for use.

11. Ensure the animal is in a comfortable position, with the skin accessible for the procedure and the animal’s head facing away from the light (or cover the animal’s eyes to protect from the light).

12. Use the spatula to apply approximately a 2 mm thick layer of the PHOVIA Gel on the surface of the skin.

13. Ensure everyone in the room (such as the veterinarian, the assistant or the animal’s owner) wears the supplied safety goggles before turning on the PHOVIA LED Lamp. Two sets of goggles are provided with the PHOVIA LED Lamp. Clean the goggles in between uses, as indicated in the manufacturer instructions.

14. Follow PHOVIA LED Lamp Instructions for Use. The distance between the light source and the skin area is achieved by positioning the lamp’s cone as close as possible to the skin without touching it. The LEDs are 5 cm from the edge of the cone. Ensure that the distance is maintained throughout the illumination.

15. Begin the 2-minute illumination period.

16. The lamp will shut down automatically once the 2-minute period is completed. The animal should not be left unsupervised.

17. Once the procedure is completed, gently remove the PHOVIA Gel from the skin with a gauze soaked in sterile saline solution. If the animal does not allow it, it is not necessary to remove the gel.

18. Dispose of all materials after use following veterinary clinic or hospital disposal procedures.

19. The 2-minute illumination should be repeated twice weekly until desired result is achieved. Alternatively, two consecutive 2-minute applications (apply the gel, illuminate, remove gel, wait 1 minute, re-apply the gel, illuminate and remove gel) should be repeated weekly until desired result is achieved.

8. Glossary of Symbols