Mediswab

Instruction For Use (IFU)

1. Introduction

I. Product Description

• Product Name: Gauze Swab (Without X-ray Detectable Thread)
• Brand Name: Mediswab (Sterilized by ETO)
• Raw Material: Absorbent cotton gauze

Gauze Swab (Without X-ray Detectable Thread) are absorbable cotton gauze folded into rectangles or square of various ply in such a manner that no cut edges are exposed, the edges of the swab are unstitched.

They are supplied as sterile, sterilized via ETO and Gamma Irradiation.

Gauze Swab (Without X-ray Detectable Thread) is for single use and designed for use in healthcare settings. The product is designed to be soft, absorbent, and low linting.

II. Intended Purpose

Gauze swabs are used to place over a wound before taping, strapping, or bandaging up or can be soaked in antiseptic liquid and used to wipe over wound sites. Gauze swabs are also useful for padding, protection, blood spill wound dressing, applying antiseptic, and use in surgery to absorb blood & exudates.

III. Duration of use

Gauze swab (without X-ray detectable thread) is used for wound healing which may take up to few days to heal and surgical procedures which may last more than 24 hours. 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

• Wound cleaning, act as a barrier and for padding
• Hemostasis
• Absorption of blood and exudates from wound
• Reduction in wound size
• Wound healing, absorption of blood and body fluid during surgery.

V. Contraindications

Not to be used in patients with known hypersensitivity to any of the Cotton materials used.

VI. Intended User

Healthcare Professional

VII. Patient Population

All Patient Population

VIII. Clinical Benefits

• Wound healing, absorption of blood and body fluid during surgery and X-ray detection property

2. Indication for Use

• For swabbing and absorbing body fluids or blood during surgical procedures
• Wound dressing
• Promote wound healing
• Protect wound from infection
• General wound care

3. Sterility

Gauze Swab (Without X-ray Detectable Thread) are supplied as sterile, sterilized via ETO and Gamma Irradiation.

4. Instructions for Use

• Ensure packing is intact and clean before use of these products.
• Open packed pouch carefully.
• To apply the gauze swab, ensure the wound is cleaned thoroughly to remove any debris or foreign bodies.
• Ensure the shape and size of the gauze swab is applicable to the size of the wound that is being treated.
• The gauze swab can be placed directly onto the wound, as it is not adhesive and sterile. The gauze swab is simply held in place over the wound, allowing it to soak up all the discharge secreted by the wound.
• If the gauze swab is used to clean the wound, a small volume of disinfectant can be added onto the swab, and the wound can be gently dabbed.
• Once the gauze swab is saturated, or the wound has stopped discharging fluid(s), the gauze swab can be removed and disposed of.
• Take care not to touch the wound, as this may aggravate it.
• Changing the gauze swab frequently is recommended.

5. Shelf Life

The device has a restricted shelf life of 04 years.

6. Warnings

• Read IFU before use.
• May leave residue in the wound bed.
• May injure fragile skin or granulating tissue on removal.
• Do not reuse: Reuse may compromise product integrity and sterility is lost 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 patient due to re-sterilization of device.
• Improper transport and handling may cause structural and /or functional damaged of device or packaging.
• Do not cut the gauze or open them up exposing raw edges.
• Contents are sterile, 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.
• Do not use after expiry date.
• Use immediately after opening the pack.

7. Limitations

Gauze swabs are not used for wounds or injury which have breached the dermis and can heal by secondary intent.

8. Side effects

• Pain 
• Infection
• Allergic reaction
• Gossypiboma- a term used to denote a mass of cotton material, usually, gauze, sponges and towels, inadvertently left in the body cavity at the end of a surgical operation.   

9. Precautions

• This product for single use only, discard after single use.
• Please do not repeat sterilization.
• Use the product immediately after opening the individual package
• Ensure packing is intact and clean before use of these products
• This product has an expiration date and should be used before the labeled expiry date marked on the packet and box.

10. Storage

Storage temperature shall not be more than 30°C, keep in dry place and away from direct sun light.

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 Ethylene Oxide
	Do not re-sterilize		Sterilized using gamma irradiation
	Keep away from sunlight		Do not use if the packaging is damaged
	Latex Free		Batch Code
	Use-by dat e YYYY-MM		Catalogue Number
	Medical Device		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
	CE Mark with Notified Body Number		UDI Number
	Upper limit of temperature		Caution
	Country of Manufacture – India		Single Sterile Barrier System
	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