DeRoyal Algidex AG Pin on Wound Dressing Instructions

DeRoyal Algidex AG Pin on Wound Dressing Instructions

Introduction

| USE BY DATE
---|---
**| DO NOT REUSE
| | STERILIZED USING IRRADIATION
| NOT MADE WITH NATURAL RUBBER LATEX
RX ONLY| FEDERAL U.S.A. LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A PHYSICIAN OR PROPERLY LICENSED PRACTITIONER.**

IMPORTANT INFORMATION

Please read all instructions, warnings and cautions before use.
Correct application is essential for proper functioning of the product.
Use only on the person it was provided to by a healthcare professional and only for the use it was intended.

DEVICE DESCRIPTION

Algidex Ag® silver alginate wound dressings are an antimicrobial barrier for up to seven (7) days.
The dressings utilize a formulation of ionic silver combined in an alginate and maltodextrin matrix.
The dressings are offered in three configurations: 1. A paste; 2. A paste applied to a non-adherent polyurethane foam layer, in various sizes and shapes; 3. A paste applied to a non-adherent wound contact layer.

INTENDED USE

Algidex Ag® silver alginate wound dressings are intended to manage exudating wounds, including abrasions and lacerations, dermal wounds, donor sites, first- and second-degree burns, surgical incisions, vascular access sites, pressure ulcers stage I-IV, stasis ulcers, and venous ulcers.

CONTRAINDICATIONS

• Algidex Ag® Wound Dressing should NOT be used:
• on patients with sensitivity to silver, silver compounds or alginates
• on third-degree burns
• ulcers resulting from infections
• lesions in patients with active vasculitis
• DO NOT surgically implant.

WARNINGS:

• Local wound care cannot overcome the deficits of unrelieved malnutrition, pressure or trauma, or compromised blood flow. Interventions must be instituted to reduce or relieve factors that contribute to impaired wound healing to achieve the optimum outcome.
  When visible signs of infection are present, use these dressings in conjunction with proper systemic medical treatment to address the cause of the infection.

• DO NOT use when contraindicated.

• Discontinue use if signs of sensitivity or irritation appear.

• Product is sterile unless packaging is opened or damaged. DO NOT use if product is expired or if packaging is open or damaged.

• DO NOT use for longer than seven (7) days.

• This product is prescription only. DO NOT provide it to the patient without providing complete use instructions.

• Remove product and cleanse wound thoroughly prior to hyperbaric oxygenation or any other therapy where the presence of metals is contraindicated.

CAUTIONS

• DO NOT store in extreme temperatures or in a damp environment. This may render the product ineffective.

DIRECTIONS FOR USE

ALGIDEX AG® FOAM

1. Thoroughly cleanse wound with normal saline.
2. Apply Algidex Ag® Wound Dressing with silver matrix touching the wound.
3. Secure dressing in place with retention dressing such as gauze, transparent film, or tape.
4. Dressing may be worn up to seven (7) days or until dressing has reached saturation, whichever occurs first.

REMOVAL OF ALGIDEX AG® FOAM

1. Remove retention dressing, if applicable.
2. Lift Algidex Ag® Wound Dressing from the wound. If dressing adheres to wound, gently irrigate with saline to help loosen dressing.
3. Discard according to institutional policy.
4. Once dressing is removed, thoroughly cleanse wound with normal saline to remove any residue from wound drainage and Algidex Ag® Wound Dressing.

ALGIDEX AG® THIN FILM

1. Thoroughly cleanse wound.
2. Remove Algidex Ag® Film from its backing.
3. Place film over shallow wounds or pack into deep wounds.
4. Cover with gauze, or absorbent dressing. Secure in place.
5. Dressing may be worn up to five days or until retention dressing reaches saturation, whichever occurs first.

ALGIDEX AG® PASTE/GEL

1. Thoroughly cleanse wound.
2. Apply 1/4” thickness of paste/gel to shallow wounds or completely fill deep wounds.
3. Cover with appropriate secondary dressing such as gauze, hydrocolloid foam or film, based on wound drainage.
4. Algidex Ag® Paste/Gel may be worn up to seven (7) days or until secondary dressing requires changing, whichever occurs first.

REMOVAL OF ALGIDEX AG® THIN AND ALGIDEX AG® PASTE/GEL

1. Remove secondary dressing.
2. Gently irrigate wound with saline to loosen Algidex Ag® paste/gel/thin.
3. Continue to thoroughly cleanse wound to remove wound drainage or residue from Algidex Ag®.

EXPIRATION INFORMATION

• Store Algidex Ag® Wound Dressing in a cool, dry place.
• Contents sterile unless package has been opened or damaged.
• See package label for expiration date.

STORAGE AND TRANSPORT CONDITIONS

| KEEP DRY
---|---
| KEEP AWAY FROM SUNLIGHT
**| DO NOT USE IF PACKAGE IS DAMAGED**

In addition to the competent authority in the country where the patient resides, serious incidents must be reported to DeRoyal Industries, Inc.

WARRANTY

DeRoyal® products are warranted for one hundred twenty (120) days from the date of shipment from De Royal as to product quality and workmanship.
DEROYAL’S WRITTEN WARRANTIES ARE GIVEN IN LIEU OF ANY IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Customer support

PART# 634062
Revised 8/2021
©2021 DeRoyal Industries, Inc.
All Rights Reserved. DeRoyal, the DeRoyal logo,
Improving Care. Improving Business., and Algidex
Ag are trademarks or registered trademarks of
De Royal Industries, Inc.
Manufactured by:
DeRoyal Industries, Inc.
200 De Busk Lane
Powell, TN 37849 USA
888.938.7828 or (001) 865.938.7828
www.deroyal.com

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