Instructions for Use

Product Description

AGNAVELIS Silver Nitrate Applicator Sticks consist of a rigid wooden shaft with a treated tip containing 75% silver nitrate and 25% potassium nitrate. The product is a Class I medical device, supplied non-sterile and intended for single use. It is supplied in applicator stick format as individually packed sticks.

Intended purpose

• Chemical cauterisation of small superficial bleeding sites.
• Controlled reduction of excessive granulation or hypergranulation tissue.
• Clinically appropriate localised applications in wound and stoma care.
• Other small superficial lesions where localised cauterisation is considered appropriate by a healthcare professional.

Intended user and patient population

The device is intended to be used by trained healthcare professionals, for patients in whom localised chemical cauterisation is clinically indicated. Use in paediatric patients, or during pregnancy or breastfeeding, should follow an individual professional clinical assessment.

Contraindications

• Known hypersensitivity to silver nitrate or potassium nitrate.
• Uncertain, atypically coloured or shaped lesions, or lesions suspected of malignancy, unless assessed by an appropriate physician.
• Direct application to the eye or peri-ocular tissues.
• Use over large body surface areas, on deep tissues, or outside the intended purpose.

Warnings and Precautions

• For professional use only.
• The product is non-sterile. Do not use where the procedure requires a sterile device.
• Single use only. Do not reuse, reprocess or re-sterilise.
• Do not touch the active tip with bare or wet hands. Wear appropriate gloves, and eye protection where indicated.
• Limit contact with healthy tissue; silver nitrate may cause chemical irritation and dark staining of healthy skin.
• Protect clothing, work surfaces and equipment, because silver nitrate may cause persistent brown-black stains.
• When used in or near the mouth, prevent ingestion of fragments of the active tip.
• Keep out of reach of children.
• Do not use if the packaging is damaged or wet, or if the product shows visible deterioration.

Application overview

1. 1Confirm that the product, the packaging and the expiry date on the label are intact and suitable for use.
2. 2Clean and dry the application area in line with the applicable clinical procedure.
3. 3Protect the surrounding healthy tissue so that contact is limited to the intended target area.
4. 4Moisten the active tip only if the clinical procedure requires it, following the Instructions for Use.
5. 5Apply the tip to the target area briefly and with controlled pressure, avoiding contact with healthy tissue.
6. 6Observe the treated area, and remove excess product from surrounding tissue where indicated.
7. 7Discard the applicator immediately after a single use, in accordance with local waste regulations.

The full application procedure, including contact times and clinical considerations, is described in the complete Instructions for Use.