Product Manual

Instructions for Use
Description
CuraFoam AG Silver Foam Dressing mainly includes polyurethane foam, polyvinyl alcohol, silver sulfate
and silver chloride. It is a highly absorbent foam dressing with ionic silver as the active component. The
dressing provides an optimal moist wound healing environment, combining an effective antibacterial activity
in the dressing with exudates management. The dressing has broad spectrum antibacterial effect for Gram
positive and Gram negative bacteria. It has been shown to have 4 log bacterial reductions up to 7 days
in vitro against the following bacteria: Staphylococcus aureus, Streptococcus pyogenes, Enterococcus
faecalis, Escherichia coli, Klesiella pneumoniae, and Pseudomonas aeruginosa. CuraFoam AG Silver Foam
Dressing are available in various sizes and shapes. The dressings are packaged in individual bags.
Indications
CuraFoam AG Silver Foam Dressing is indicated for exudate absorption and the management
of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic ulcers, rst
and second-degree burns, donor sites, post-operative wounds and skin abrasions.
Contraindications
1. Do not use CuraFoam AG Silver Foam Dressing on patients with known sensitivity to silver.
Product Information:
Antibacterial Agent: Silver sulfate and silver chloride
Spectrum of Activity: Broad spectrum antibacterial effect for Gram positive and Gram negative bacteria
Concentration on the device: Each dressing contains 0.35~0.40mg/cm3 silver
In Vitro Study Results:
The device is non-irritating, non-cytotoxic and biocompatible in a wound environment.
The device is tested for antibacterial activity for up to 168 hours. The device has broad
spectrum antibacterial effect for gram positive and gram negative bacteria.
Bacterial Staphylococcus aureus Streptococcus pyogenes Enterococcus faecalis
ATCC 6538 ATCC 19615 ATCC 29212
168 Hour % Reduction >99.99% >99.99% >99.99%
Bacterial Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa
ATCC 8739 ATCC 4352 ATCC 9027
168 Hour % Reduction >99.99% >99.99% >99.99%
Instructions for Use
1. Clean the wound with sterile saline water and dry the surrounding skin gently.
2. Choose the right size dressing to cover the wound area.
3. Cover and secure the CuraFoam AG Silver Foam Dressing with a secondary dressing.
4. Dressing change frequency will depend on patient condition and the level of exudates. Initially it may be
necessary to change the dressing every 24 hours. When the exudates reduce, the frequency may decrease.
5. Gently remove the secondary dressing. If the wound appears dry, saturate the dressing with sterile saline
water prior to removal.
Warnings
1. This product is for single use. Do not use if pouch is damaged or open.
2. Do not use this product on a dry wound.
3. Frequent or prolonged use of this product may result in permanent discoloration of the skin.
4. The silver is only present as a preservative within the dressing.
5. CuraFoam AG Silver Foam Dressing is intended for short-term use and should
not be used for more than 28 days over multiple dressing changes.
6. Reduction in colonization or microbial growth on the device has not been shown to correlate with a reduction
in infections in patients. Clinical studies to evaluate reduction in infection have not been performed.
Specications
Code Size Product Description
3046 5cm×5cm Non Border
3047 10cm×10cm Non Border
3048 15cm×15cm Non Border
Storage: Please store the product in sealed, cool and dry place avoiding light.
Shelf life: 3 years from date of manufacture.
Manufactured for:
Dynarex Corporation
Orangeburg, NY 10962
www.dynarex.com
Made in China Copyright © 2015 Dynarex Corporation. All rights reserved. r0
CuraFoam
™
AG
Silver Foam Dressing