This product has been cleared by the FDA for sale in the United States. Cleared indications for use (K062544)

Selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.

This product has been cleared by the FDA for sale in the United States. Cleared indications for use (K131096)

• Selective and non-selective dissection and fragmentation of soft and/or hard tissue

• Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter.

• Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue)

• Contact and/or non-contact maintenance debridement for the removal of debris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter

• Preparing the wound bed for graft or other subsequent procedures using contact and/or non-contact techniques to achieve wound debridement

• It is prescribed for patient population of any age with one or more wounds and/or that may also exhibit Diabetes Mellitus (DM)

Ideal for

• Wound Management

• Treating specific types of wounds including:

• Diabetic foot ulcers

• Pressure ulcers

• Venous Insufficiency Ulcers

• Arterial Wounds

• Compromised Surgical Wounds

• Burns

• Osteomyelitis

• Fistulas

• Infected, Eczematous, Ulcerated or Devitalized Skin

  
  

Recommended Treatment

This process is directed for single (1) treatment, and total recommended treatment shall be no more than three (3) times per week; typically treatment regimen is approximately two (2) weeks or more, depending on the size and nature/condition of the treated area as well as other subject dependent factors, but may be prescribed longer on the order of a physician.

Cleaning Solutions

The Qoustic Wound Therapy System™ can be used with the following irrigation (lavage) fluids:

• Sterile 0.9% saline (which is widely available for purchase from medical suppliers)

• Sterile de-ionized water

• Vashe™ Wound Cleanser solution (which is produced from PuriCore’s Vashe™ Generator)

• Other solutions approved for wound therapy or debridement

Product Specifications

• Generator power source: 90-264~, 2.5A, 50-60Hz

• Converter Power Output: <140 watts

• Amplitude: 0 – 75 μm

• Frequency: 35kHz (±2kHz)

• Weight:

  Generator: 13.5 lbs (6.1kg) [AR1000B];

  Handheld Applicator: 13.5 oz (0.4kg) [AR1000] / 11.5 oz (0.3kg) [AR1000D]

• Dimensions:

  Generator: 15.50 in (W) x 14.25 in (D) x 5.25 in (H);

  Handheld Applicator: 9 in x 1.4 in (Ø)

*Contact a Sales Representative for pricing