RENASYS* TOUCH Negative Pressure Wound Therapy

• Intuitive touch screen
• Range of alarms including low battery, canister full, blockage, low vacuum, leak, and maintenance notification
• New attachments enable easy use in an inpatient environment
• Powerful pump can manage highly exuding wounds
• Up to 16 hour battery life enables prolonged use
• Patient lock-out function for safety
• Improved patient safety
• Suitable for use in hospitals, long-term care facilities, LTACs, and skilled nursing facilities
• Smith+Nephew provides a 24/7 NPWT Hotline for both clinicians and patients
• Pump therapy log to review compliance
• Variable intermittent therapy
• On-screen help icon appears when an alarm is activated, which takes the user directly to an on board IFU to review troubleshooting steps to resolve the alarm

The RENASYS* TOUCH is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates, and infectious materials.

Examples of appropriate wound types include: chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burn, flaps, and grafts.

Contraindicated for use 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, and anastomotic sites.

Patients must be closely monitored for bleeding. If sudden or increased bleeding is observed, immediately discontinue therapy, take appropriate measures to stop bleeding, and contact the treating clinician.

Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of bleeding. During therapy, avoid using hemostatic products that may increase the risk of bleeding, if disrupted.

Sharp edges or bone fragments in a wound must be covered or removed prior to using the RENASYS* TOUCH system due to risk of puncturing organs or blood vessels while under negative pressure.

Do not use RENASYS* TOUCH on exposed blood vessels or organs.

In the event defibrillation is required, disconnect the device from the wound dressing prior to defibrillation. Remove the wound dressing if it will interfere with defibrillation.

The RENASYS* TOUCH is not MRI or CT compatible. Do not bring RENASYS* TOUCH into the MRI suite or scanner range.

When operating, transporting, repairing, or disposing of the RENASYS* TOUCH and its accessories, the risk of infectious liquids being aspirated or contamination of the device through incorrect use cannot be eliminated. Universal precaution should be observed whenever working with potentially contaminated parts or equipment.

RENASYS* TOUCH has not been studied on pediatric patients. Patient size and weight should be considered when prescribing this device.

RENASYS* TOUCH is unsuitable for use in areas where there is danger of explosion (eg, hyperbaric oxygen unit).

The canister kits are provided non-sterile. Do not use in a sterile field.

Precautions should be taken for patients who are or may be receiving anticoagulant therapy or platelet aggregation inhibitors, actively bleeding or have weakened blood vessels or organs, suffering from difficult wound hemostasis, untreated for malnutrition, noncompliant or combative, suffering from wounds in close proximity to blood vessels or delicate fascia.

Infected wounds may require more frequent dressing changes. Continuous monitoring of the wound must be maintained to check for signs of infection.

Therapy should remain ON for the duration of the treatment. A dressing should not be left in place without active negative pressure wound therapy.

This device should only be used by qualified and authorized personnel. The user must have the necessary specialist knowledge of the specific medical application for which RENASYS* TOUCH is being used.

If the device has been at temperatures below freezing, the device must be brought to room temperature prior to use or the pumping unit may be damaged.

Ensure the tubing is installed completely and without any kinks to avoid leaks or blockages in the vacuum circuit.

Position the device and tubing appropriately to avoid the risk of causing a trip hazard and so the patient does not lie on the tubing.

When bathing/showering, the patient must be disconnected from the device.

If any liquids penetrate the pump, discontinue use and return to your authorized provider for service. Check the overflow protection/bacteria filter and replace as necessary.

Do not apply NO-STING SKIN-PREP* wipes directly onto open wounds.

Always use the smallest canister volume possible. Do not use the 800ml/cc canisters on patients with a high risk of bleeding.

Underlying structures, such as bone and tendon, must be covered by the non-adherent dressing layer.

Inspect the dressing site as appropriate based on therapeutic need.

The vacuum level should never be painful. If the patient reports discomfort with the vacuum level, consider reducing the pressure.

The use of negative pressure presents a risk of tissue ingrowth into the foam/gauze. Tissue ingrowth may be reduced by lowering therapy pressure, using a wound contact layer or by increasing the frequency of dressing changes.

RENASYS* TOUCH is only to be used with Smith+Nephew authorized components. RENASYS* TOUCH is only to be used in the upright position.

Device should be stored between 5°C to 40°C (41°F to 104°F) for optimal battery performance, but can be stored between -25°C to 70°C (-13°F to 158°F) for short periods of time. Relative humidity: 15% to 93%. Atmospheric pressure: 700 mbar to 1,060 mbar.