• Two large hydrophobic polyurethane foam dressings: Foam dressing with several cuts to facilitate custom sizing if needed
• One Soft Port: Designed to be very resistant against blockages caused by kinks, twists, and compressions (may help reduce the need for bridging techniques)
• One organ protection layer: Elliptical shaped organ protection layer with slits to provide protection of vital structures
• Six transparent film dressings: For fixation of dressings

RENASYS* AB Abdominal Dressing Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary.
It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.
The use of RENASYS* AB Abdominal Dressing Kit with Soft Port is intended for use in acute hospital care settings (trauma, general, and plastic surgery wards) and should ideally be applied in the operating room.

The use of RENASYS* AB Abdominal Dressing Kit with Soft Port is contraindicated in the presence of:
• Vital organs and structures not covered with the Organ Protection Layer (OPL)
• Patients with on-going or high potential for hemorrhage and/or enteric leak
• Untreated osteomyelitis
• Necrotic tissue with eschar present
• Malignancy in wound (with exception of palliative care to enhance quality of life)
• Non-enteric and unexplored fistulas
Foam should never be placed in contact with exposed bowel, arteries, veins, organs, or nerves.
Utilize the OPL at all times when using the RENASYS* AB with the RENASYS* NPWT system.

NOTE: Ensure aseptic technique is used during the application of all components of RENASYS* AB. Ensure the abdomen and its contents are adequately visualized, controlled, and protected throughout application of the dressing.
1. Surgical intervention with RENASYS* AB should only be undertaken as part of a holistic medical management strategy.
2. Frequent, standardized measurements of intra-abdominal pressure (IAP) and/or abdominal perfusion pressure (APP) are recommended before, during, and after treatment with RENASYS* AB, as a means of guiding clinical decisions concerning management of the open abdomen.
3. RENASYS* AB is not intended to provide primary treatment for infection in the open abdomen. RENASYS* AB may, however, be used on septic open abdomens, which are being managed in accordance with institutional clinical protocols for infection abatement, as an adjunct to the standard treatment regimen, and/or to provide a barrier to bacterial penetration.
4. Use of the OPL is necessary to protect exposed organs from the foam and extraperitoneal tissues to which adhesion may form. Preventing adhesions or obstructions that may otherwise form during open abdominal wound management is a critical parameter in achieving timely primary facial closure and reducing the chance of fistula development. The OPL must completely cover all exposed viscera, prior to application of wound filler and subsequent activation of the NPWT system.
5. Use caution when utilizing RENASYS* AB with patients suffering from obstruction in the small or large intestine, which may include (but is not limited to) hernias, adhesions from previous abdominal surgery, or from underlying pathologies such as Crohn’s Disease or Irritable Bowel Syndrome (IBS).
6. Patients with vascular or intestinal anastomosis (including, but not limited to arterial grafts or gastric bypass) require careful consideration while using RENASYS* AB. Patients with enteric fistula have an increased risk of abdominal contamination if output is not carefully managed during the course of treatment with RENASYS* AB.
7. During the course of treatment, the RENASYS* AB dressing and NPWT system will remove third space fluid from the abdominal compartment. Large volumes of fluid can be collected during the course of treatment. The volume and appearance of the fluid in both canister and canister tubing should be checked and recorded frequently while patient is receiving therapy. The canister should be replaced when contents reach maximum volume indication (250ml or 800ml fill line). Viscous exudates increase the risk of blockage in the system; monitor closely.
8. The fluid level in the canister may be used as an approximate guide when considering the necessity of fluid replacement. Planning for fluid replacement should be a clinical consideration in all patients undergoing therapy with RENASYS* AB.
9. Protection of the periwound skin area from moisture and adhesive irritation may be accomplished through the use of a skin-sealant. Allow the skin-sealant to dry fully prior to placement of the transparent film. Because of the risk of further damage to the periwound area, foam should never overlap onto intact skin without first protecting the skin with additional transparent film or a hydrocolloid dressing.
10. The lowest recommended therapy pressure for using RENASYS* AB with the RENASYS* TOUCH device is 80mmHg.
11. While using RENASYS* AB, apply universal precautions according to your institution’s protocols, to minimize the risk of contact with any blood-borne pathogens.

Store in a dry place (<25°C, 77°F).