Unsterile

Instruction For Use (IFU)

1. Introduction

I. Product Description

• Product Name: X-Ray Detectable Abdominal Pad
• Raw Material: Absorbent cotton gauze and X-ray detectable thread

The X-Ray Detectable Abdominal Pad is an absorbable non-adherent and non-occlusive dressing material, made from cotton with a radiopaque thread sewn into the sponge to aid in X-Ray detection. All four edges are stitched to prevent loose thread.

The product is available in various sizes and is supposed to be sterilized before use.

X-Ray Detectable Abdominal Pad is for single use and intended for use in healthcare settings. The product is designed for maximum absorbency and disperse fluids quickly and evenly.

X-Ray Detectable Abdominal Pad is commonly known as Lap Pad, Lap Sponge, Abdominal Lap pad, Abdominal lap sponge.

II. Intended Purpose

X- Ray Detectable Abdominal Pads are intended for use in abdominal surgery for absorption of blood and exudates. it can also be used as padding for pressure points and where high absorbency is required. X-ray detectable Abdominal pad can be detected inside the patient by the use of X-ray equipment in the unlikely event of a swab being unaccounted for after closure.

III. Duration of use

X-ray detectable abdominal pad is used in surgical procedures which may last more than 24 hours. Hence the duration of use of the device is short term i.e. more than 24 hours and less than 30 days.

IV. Performance Characteristics of Device

• Hemostasis
• used as pressure pad
• Absorption of blood and exudate during surgery and X-ray detection property.

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

• Absorption of blood and exudate during surgery and X-ray detection property.

2. Indication for Use

X- Ray Detectable Abdominal Pad is indicated for used during surgery for absorption of blood and exudates keeping the surgical area free of excessive body fluids, blood, and other liquids, allowing the surgical team to clearly visualize the surgical region. It can also be used to apply pressure to stop bleeding.

3. Sterility

X-Ray Detectable Abdominal Pad is supplied as non-sterile, but need to sterilize before use by Steam sterilization (Autoclave).

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

• Ensure packing is intact and clean before use of these products.
• Open packed pouch carefully.
• To apply the sponge, it is important to first check that the shape and size of the sponge for its application
• The pad is simply held in place over the site, allowing it to soak up all the discharge secreted.
• Once the pad is saturated, or the discharging fluid(s) have stopped, the pad can be removed and disposed of.
• Take care not to touch the wound, as this may aggravate it.
• Changing the pad frequently is recommended.
• If the pads get saturated or soiled, it should be replaced immediately with a fresh sponge.

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 abdominal pad or open it 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.
• Use immediately after opening the pack.

7. Limitations

Correct sized laparotomy sponges should be used based on the size of the wound. If a wound is large, a large enough sponge must be used to effectively absorb its discharge or clean it

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.
• 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.
• Correct size should be used based on the size of the wound. If a wound is large, a large enough sponge must be used to effectively absorb its discharge or clean it;
• Use protective gloves on clean and dry hands to avoid direct contact with body fluids and liquids.

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
	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		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.