
• Non-contact, low-frequency ultrasound (NLFU)
• Pain-free delivery through a fluid/saline mist that acts as the medium to deliver energy to the wound
• Easy to set up/use - turn system on, attach disposable single use applicator and saline, select wound size and start treatment
• Can be administered by any trained health care professional
• Supported by vast array of clinical evidence
• Promotes healing by mechanically removing barriers to healing
• Reduces and removes a wide range of bacteria in the lab
• Increases perfusion through vasodilation ultimately increasing oxygen and nutrients to the tissue
UltraMIST® produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.
Do not use near electronic implants/prosthesis (e.g., near or over the heart or over the thoracic area if the patient is using a cardiac pacemaker); on the lower back during pregnancy or over the pregnant uterus; over areas of malignancies.
Caution: Federal law restricts this device to sale by or on the order of a licensed practitioner.
Risk of electric shock - Do not remove cover or loosen cable connections. Refer servicing to qualified service personnel.
Do not use if treatment wand or cables show evidence of deterioration or damage.
Discard disposable applicator components appropriately.
Risk of burns - Do not touch the metal tip of the treatment wand during operation.
Do not depress the treatment on/off button if an applicator is not in place.
Do not aim the mist at eyes or use on wounds near the eyes without proper eye protection.
Do not allow the treatment wand or applicator to contact the patient’s skin directly.
Use of the UltraMIST® System on uncovered surgical wounds should only be performed under the order of a physician.
Treatment effectiveness may be diminished if any of the following occur:
The applicator is not fully engaged, aligned and securely attached to the treatment wand.
The distance between the leading edge of the applicator and the wound is greater than 1.5cm (0.6").
The treatment wand is not held perpendicular to the wound.
Infection or suspected infection of the wound should be evaluated by the physician for appropriate intervention.
Use of iodine-based products may cause staining of the treatment wand and generator enclosure material and is not recommended.
If a product is damaged or suspected to be damaged in any way it should not be used for a patient treatment.
Applicator/system transport and storage:
Temperature: -25°C to 70°C
Relative humidity: 30% to 75% (non-condensing)
Continuous mode | |
Splash guard attachment | |
High frequency | |
Kilohertz | ● |
Low frequency | ● |
Megahertz | |
Single-patient use | ● |
Pulsed mode | |
Selective debridement | |
Battery-operated | |
Non-contact | ● |
Non-thermal | ● |
Gel couple medium use | |
Portable | ● |
Detachable probes | |
Aqueous couple medium use |
Educational Material Available | ● |
Free Samples/Trials Available | ● |
Published Clinical Article Available | ● |
Acute Wounds
Burns
Cavity Wounds
Chronic Wounds
Deep Tissue Injuries
Deep Wounds
Dehisced Wounds
Diabetic Foot
Granulating/Epithelializing Wounds
Infected Wounds
Moderate/Highly Exudating Wounds
Non/Minimally Exudating Wounds
Palliative Wounds
Pressure Ulcers
Sloughy Wounds
Superficial Wounds
Surgical Wounds
Venous Ulcers
Frequency of patient treatment is to be determined by the treating physician after appropriate patient evaluation. Good clinical practice dictates re-evaluation of the wound at routine intervals by a qualified health care professional. If no improvement is noted, the use of this therapy should be reconsidered.
Celularity, Inc. is a biotechnology company that produces cells and tissues derived from the postpartum placenta. Its portfolio of products supports the body's ability to regenerate tissue and includes BIOVANCE® Human Amniotic Membrane Allograft, Interfyl® Human Connective Tissue Matrix and UltraMIST® System.