Medifin

Instruction For Use (IFU)

1. Introduction

I. Product Description

• Product Name: Paraffin Gauze Dressing
• Brand Name: Medifin
• Raw material: Coarse Leno Cloth, White Soft Paraffin, Ceto Steryl Alcohol, PVP paper

Paraffin Gauze Dressing is sterile, non-invasive dressing material. Paraffin is present to reduce the adherence of the product to the surface of a granulating wound.

Paraffin Gauze Dressing is sterilized by Gamma Irradiation.

Paraffin Gauze Dressing is for single use and designed for use in healthcare settings. It is a soft paraffin dressing that is not medicated. It is soothing and low-adherent and allows the wound to drain freely into an absorbent secondary dressing.

II. Intended Purpose

Paraffin Gauze Dressing is intended to be used as a primary wound contact layer in the treatment of donor and recipient graft sites, skin loss wounds, minor burns, scalds, laceration, abrasions, and leg ulcers.

III. Duration of use

Paraffin Gauze Dressing is used for wound healing which may take up to few days to heal. Hence the duration of use of the device will be short term i.e. more than 24 hours to less than 30 days.

IV. Performance Characteristics of Device

• Non-adherent primary dressing, maintains the moist environment of wound
• Allows drainage of blood and exudates to secondary dressing via mesh
• Wound healing

V. Contraindications

• If dressing is placed upon heavily exudating wound, the semi-occlusive nature of gauze may cause tissue maceration by preventing free movement of exudate away from surface of wound.
• Contraindicated in patients who have known to be hypersensitive to paraffin.
• Seek medical advice immediately for all serious wounds and burns if redness or discomfort occurs.
• Do not use for cavity wound.

VI. Intended User

Healthcare Professional

VII. Patient Population

All Patient Population

VIII. Clinical Benefits

• Wound Healing

2. Indication for Use

Paraffin Gauze dressing is indicated for minor burns and scalds, donor and recipient graft sites, skin loss wounds, lacerations, abrasions and leg ulcers.

3. Sterility

Paraffin Gauze Dressing is supplied as sterile, sterilized by Gamma Irradiation.

4. Instructions for Use

Application

• Ensure packing is intact and clean before use of this product.
• To apply the paraffin dressing, ensure the wound is cleaned thoroughly to remove any debris or foreign bodies.
• Wash hands thoroughly. Open the packaging containing the gauze dressing, and peel off the protective layer, exposing the dressing.
• Once the dressing is applied to the wound, a second dressing or bandage should be applied over it to reinforce the covering, bolstering level of protection.
• Take care not to touch the wound, as this may aggravate it.
• Changing the dressing on a frequent basis is recommended.
• It is completely dependent on the expertise and experience of the healthcare practitioner to choose which size of gauze will be used in respective circumstances.

Removal

• The paraffin gauze dressing should be removed carefully to prevent destruction of new tissue.
• The removed paraffin gauze dressing shall be disposed off in accordance with accepted medical practice and applicable local, state and country laws and regulations for handling of bio- medical waste

5. Shelf Life

The device has a restricted shelf life of 04 years.

6. Warnings

• Read IFU before use.
• Do not reuse: Reuse may compromise product integrity and lead to device failure which could cause patient injury, illness, or infection.
• Do not re-sterilize – if the device is re-sterilized, it may cause harm or infection to the patient due to the re-sterilization of the device.
• Improper transport and handling may cause structural and /or functional damage to the device or packaging.
• Do not cut the gauze or open them up exposing raw edges.
• Do not use if the package is opened or damaged in any way.
• Do not use if any changes are noted in performance during usage.

7. Limitations

• Due to presence of soft paraffin coating on Paraffin Gauze Dressing, absorption of blood and exudate is not possible.
• To achieve the absorption of blood and exudate the paraffin gauze shall be used in combination with surgical gauge or other types of gauze dressings

8. Side effects

• Pain during change/removal of paraffin Gauze dressing
• Infection
• Allergic reaction

9. Precautions

• This product has an expiration date and should be used before the labeled expiry date marked on the packet and box.
• Ensure packing is intact and clean before use of these products.
• This is not an absorbent dressing. Always use secondary absorbent dressing when using for heavily exudating wound.
• The frequency of dressing changes will depend entirely upon the nature of the wound. If Paraffin Gauze Dressing is left in position for prolonged periods of time, it can become adherent and cause tissue damage upon removal.
• For Leg ulcers use only under medical supervision.

10. Storage

Storage temperature shall not be more than 30°C, keep in dry place & away from direct sunlight.

11. Disposal

Discard in proper waste container & dispose of the product in accordance with accepted medical practice and applicable local, state and country laws and regulations for handling of bio-medical waste.

12. Symbol Glossary

Symbol	Description	Symbol	Description
	Do not re-use		Manufacturer MEDICARE HYGIENE LIMITED Company Address: Survey No. 1175(Old: 240), Village Sari, Sarkhej – Bavla Highway, Ta- Sanand, District – Ahmedabad – 382220 (Gujarat), INDIA. Contact no.: +91-9374202255 Email: medica@medicarehygiene.in Website: www.medicarehygiene.in
	Consult instructions for use		Date of manufacture YYYY-MM
	Keep dry		Sterilized using gamma irradiation
	Do not re-sterilize		Do not use if the packaging is damaged
	Keep away from sunlight		Batch Code
	Latex Free		Catalogue Number
	Use-by date YYYY-MM		Authorized representative in the European community EUROPECERT UG (haftungsbeschränkt) Alsstr. 97, 41063 Mönchengladbach, Germany Contact no.: +49 (0) 2161 990 8831 Email:support@europecert.eu Website: www.europecert.eu
	Medical Device		CE Mark with Notified Body Number
	UDI Number		Upper limit of temperature
	Country of Manufacture – India		Single Sterile Barrier System
	Caution		Refer to instruction manual/ booklet
	Translation

Notice to the User: In the event of malfunction of the device or changes in its performance that may affect safety, or any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established