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RENASYS* F Foam Dressing Kits with Soft Port

RENASYS* F Foam Dressing Kits with Soft Port are intended to be used in conjunction with Smith+Nephew negative pressure wound therapy (NPWT) systems. RENASYS* Soft Port replaces traditional plastic tubing with a soft, conformable, compression-resistant alternative.

Smith+Nephew, Inc.

For over 150 years, Smith+Nephew has taken a pioneering approach to product design and services, helping to reduce the human and economic costs of wounds. *Trademark of Smith+Nephew
Toll free:(800) 876-1261 Fax:(817) 900-4100 Website: www.smith-nephew.com
Benefits

• May help reduce the need for complex bridging1,2 
• Saves time and resources when applied to awkward body areas1,2 
• Reduces interruptions to therapy1 
• Soft Port is flexible and delivers NPWT even when a patient sits or rolls on it 
• Helps to reduce alarms and interruptions to therapy 
• Reduces the transfer of pressure 
• Designed with patient comfort in mind, by helping to reduce the risk of pressure points3 

1. Carnali M, Ronchi R, Finocchi L, Spuri Capesciotti S, Paggi B. Retrospective study on the use of negative pressure wound therapy in the treatment of pilonidal cysts (sinus pilonidalis) operated on using an open technique or complicated by dehiscence of the surgery site through sepsis. Acta Vulnologica 2016;14(1):24 - 40. 
2. Hudson D, Adams K, Cockwill J, Smith J. Evaluation of a new Negative Pressure Wound Therapy (NPWT) suction port (RENASYS◊ Soft Port). Paper presented at: EWMA; 2013. 
3. Smith+Nephew 2012. A prospective, open, non-comparative, multi-centre study to evaluate the functionality and device performance of a new Negative Pressure Wound Therapy (NPWT) suction port (RENASYS Soft Port) in the management of acute, sub-acute and chronic wounds. Internal Report. CT/US/11/01.

Indications

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

Contraindications

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

Warnings and Precautions

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.

Storage Requirements

Store in a dry place (<25°C, 77°F).

How Supplied/Sizing
Soft Port, drape, foam.
HCPCS Code
Product features
check_circle Acrylic adhesive drape
cancel Adhesive border dressing
check_circle Alternative interface dressing
cancel Antimicrobial
cancel Compatible w/ topicals
cancel Flat drain kit
check_circle Foam interface dressing
cancel Gauze interface dressing
cancel Interface intact when saturated
cancel Kit components available separately
cancel Moisture vapor permeable interface
cancel Round drain kit
cancel Silicone acrylic adhesive drape
cancel Usable on closed wounds
check_circle Usable on open wounds
Other features
check_circle Educational Material Available
check_circle Free Samples/Trials Available
check_circle Published Clinical Article Available
Recommended Use

Acute Wounds
Burns
Chronic Wounds
Flaps/Grafts
Dehisced Wounds
Pressure Ulcers
Traumatic Wounds

Mode of Use/Application

For complete application guidance, please see the RENASYS* F Foam Dressing Kit IFU.

Removal & Change Frequency

For complete removal and change frequency, please see the RENASYS* F Foam Dressing Kit IFU.

Construction

For complete construction, please see the RENASYS* F Foam Dressing Kit IFU.

Warranty

Please contact Smith+Nephew for complete warranty information.

Technical Specifications

For complete technical specifications, please see the RENASYS* F Foam Dressing Kit IFU.

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