Unsterile Gauze Swab

Instruction For Use (IFU)

1. Introduction

I. Product Description

• Product Name: Gauze Swab (Without X-ray Detectable Thread)
• Raw materials: 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.

This Gauze Swab (Without X-ray Detectable Thread) is supplied as non-sterile which is supposed to be sterilized before use by steam sterilization.

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.

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

This Gauze Swab (Without X-ray Detectable Thread) is supplied as non-sterile which is supposed to be sterilized before use by steam sterilization.

4. Instructions for Use

Autoclave

• First ensure that the Autoclave & Stainless-Steel Container are clean.
• The devices are to be packed & sealed in a medical grade paper NLT 40 grammage preferably with indicator.
• The indicator will turn from pink to brown upon successful sterilization.
• The Stainless-Steel container should not be filled more than 70% of its capacity.
• Place the device in the container and close the lid prior to beginning of the sterilization cycle.
• We suggest following parameter for sterilization:

Method	Temperature	Exposure time	Pressure
Steam (Autoclave)	121± 2 °C	20 minutes	15 PSI

Precaution while loading

• Autoclaving of the device shall be carried thought trained person only.
• Ensure the lid is properly fit & safety valves are working properly.

Precaution while unloading

• When the cycle is complete, verify that chamber temperature has dropped, and the pressure is zero.
• Wear appropriate protective equipment to protect yourself from heat and steam (e.g., heat resistant gloves, lab coat, safety glasses).
• Slowly open the door to allow steam to escape gradually. Keep your face away from the door.
• Allow items to stand in the autoclave for 5 minutes before beginning the removal.

How to use

• 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.
• If the swab gets saturated or soiled, it should be replaced immediately with a fresh gauze swab.

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 lead to device failure which could cause patient injury, illness, or infection.
• Sterilize before use.
• 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

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		Non-sterile
	Do not re-sterilize		Do not use if the packaging is damaged
	Keep away from sunlight		Batch Code
	Latex Free		Catalogue Number