RENASYS* F Foam Dressing Kits with Soft Port

Soft Port, drape, foam.

RENASYS* F Foam Dressing Kits with Soft Port are intended to be used in conjunction with Smith+Nephew negative pressure wound therapy (NPWT) Systems. The Smith+Nephew RENASYS* system is indicated for patients who would benefit from a suction pump (negative pressure wound therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates, and infectious materials. Appropriate wound types include:
• Chronic
• Acute
• Traumatic
• Sub-acute and dehisced wounds
• Ulcers (such as pressure or diabetic)
• Partial-thickness burns
• Flaps and grafts

The use of the RENASYS* pumps and the Foam Dressing Kit with Soft Port is contraindicated in the presence of:
• Untreated osteomyelitis
• Exposed arteries, veins, organs, or nerves
• Necrotic tissue with eschar present
• Malignancy in wound (with exception of palliative care to enhance quality of life)
• Non-enteric and unexplored fistulas
• Exposed anastomotic sites

1. Carefully monitor patients for signs of bleeding, which may lead to interruption in therapy and hemodynamic instability. If such symptoms are observed, immediately discontinue therapy, take appropriate measures to control bleeding, and contact treating clinician.
2. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of bleeding. During therapy, avoid using hemostatic products that, if disrupted, may increase risk of bleeding.
3. Do not use directly on exposed blood vessels or organs. Sharp edges such as bone fragments must be covered or removed prior to initiating therapy, due to risk of puncturing organs or blood vessels drawn closer under the action of negative pressure.
4. NPWT has not been studied on pediatric patients. Patient size and weight should be considered when prescribing the RENASYS* pump and accessories.
5. Foam must not be tightly packed or forced into any wound area. Over-packing may interfere with distribution of NPWT evenly across the wound. This may decrease the ability of the wound to properly contract and permit exudate to remain in wound.
6. In the event defibrillation is required, disconnect the RENASYS* pump from the wound dressing prior to defibrillation. Remove wound dressing only if its location will interfere with defibrillation.
7. RENASYS* pumps are not MRI compatible. Do not bring pump component of the system into MRI suite. Prior to entering MRI suite, disconnect pump from dressing. The dressing can remain intact on patient.
8. The RENASYS* system is unsuitable for use in areas where there is danger of explosion (eg hyperbaric oxygen unit).
9. When operating, transporting or disposing of RENASYS* pump and accessories, there is risk of infectious liquids being aspirated or contamination of pump assembly through incorrect use. Universal precautions should be observed whenever working with potentially contaminated components or equipment.
10. RENASYS* pump and canister are provided non-sterile and should not be placed within a sterile field.