XSONX® Wound Hygiene System

Experience faster healing through advanced micro-vibrational wound care therapy.

XSONX® Wound Hygiene System (WHS) is a battery-operated wound care device used to cleanse and debride a variety of wound types. The system includes a reusable handpiece, along with single-use wound heads for scrubbing and debridement, and disposable protective sleeves. It assists in removing wound debris such as exudate, dead tissue, bacterial biofilm, slough, fibrin, and fragmented material—helping to manage the wound and support a faster healing process.

INTENDED USE/INDICATIONS

The XSONX® Wound Hygiene System is intended for cleansing and excisional debridement of chronic or contaminated wounds. This includes, but is not limited to:

• Diabetic Foot Ulcers
• Pressure Injuries
• Venous Leg Ulcers
• Burns
• Traumatic Wounds
• Post-Surgical Sites

INTENDED USER(S)

The XSONX® Wound Hygiene System (WHS) is intended for use by healthcare professionals on patients with a physician’s prescription. Prior training in wound care and debridement techniques is required before operating the device. Included Accessories:

• The system uses two Energizer AAA batteries (other compatible AAA batteries may be substituted).
• Irrigation is performed using pre-filled saline bullets like Teleflex Addipak 0.9% Sodium Chloride (15mL HCS20069), or any FDA-approved wound irrigation solution.
• Each wound head is sold with a single-use sleeve.

HOW TO OPERATE THE DEVICE

1. Prepare the device and your hands: Wear gloves and wash your hands thoroughly before handling the device. To test the device, press the power button on the handpiece. A green LED indicates it’s on and vibrating. To turn it off, press again. If the light turns yellow, the batteries are low—replace them with two fresh AAA batteries.
2. Apply the protective sleeve: Slide the disposable sleeve over the narrow tip of the handpiece until it fits flush, fully covering the device.
3. Attach the wound head: As shown in the product guide, insert the wound head into the device with the power button facing upward.
4. Prepare your irrigation: To moisten the wound and aid cleaning during treatment, use sterile saline (like Addipak) or an FDA-cleared irrigation fluid.
5. Begin treatment: Place the wound head gently on the wound surface and slowly move outward from the center. Use the irrigation solution to keep the area moist throughout the process.
6. Treatment timing: Refer to the prescribing clinician for usage time. Generally, the device is used for 20–30 seconds per treatment area. For wounds smaller than 1.5 inches, 20–30 seconds is usually sufficient. Avoid using the device in the same area for more than 30 seconds unless instructed otherwise.
7. Frequency of Use The XSONX® Wound Hygiene System is generally used once a week for regular wound cleansing and maintenance. In cases involving debris or bioburden, it may be used up to three times per week, depending on clinical need. Usage frequency should be determined by the prescribing physician and regularly monitored to track healing progress.
8. Duration of Therapy Treatment duration can range from a single session to up to six months of consistent use, depending on clinical judgment and how the patient responds to therapy. The prescribing provider will determine the appropriate treatment schedule based on individual needs.
9. Wound Head Options Multiple wound head configurations are offered to accommodate various wound types and treatment needs.

Scrubbing Head

This head is intended for general wound cleansing, gentle debridement, or scrubbing, and should be used by clinicians trained in wound care or under a doctor’s prescription. It features raised, wavy grooves that are 0.8mm in height. The head can be moved in small circular motions or side-to-side (or front-to-back) across the wound surface. Chronic right medial malleolar ulcer treated with #1 scrubbing head.

Chronic right medial malleolar ulcer treated with #1 scrubbing head.

Posterolateral ankle ulcer beneath the malleolus treated with #1 scrubbing head.

Bilateral posterior ankle ulcers likely from pressure or unknown trauma; treated with #1 scrubbing head.

Chronic leg ulcer treated with #1 scrubbing head.

Small Debridement Head / Debridement Head

This head has pointed 2 mm teeth at both ends, which can be used for wound debridement by trained clinicians with a physician’s prescription. These teeth can be used to reach small or hard-to-access wound areas. It also allows angled techniques (angled back-pull) for treating wound edges. Movements should be in small circles or linear paths across the wound.

Trauma wound with CVI, DM, and PAD post-revascularization; now a VLU with moderate PAD, treated using #4 debriding head.

Right plantar heel ulcer pre-treated with methylene blue before XSONX using #4S small debriding head.

42-year-old morbidly obese female post-17-day cellulitis hospitalization with lymphorrhea, now presenting with circumferential VLU; treated using #4 debriding head.

Left TMA using #4 Debriding Head

Small Debridement Head with Curette / Purple Debridement Head with Curette

CAUTION

• A qualified medical professional must conduct a full wound assessment before deciding to perform debridement, including when using XSONX®.
• Use XSONX® cautiously for wounds involving suspected autoimmune conditions, underlying disease, or conditions like Pyoderma Gangrenosum.
• Extra care should be taken when treating patients who are on blood thinners or have bleeding disorders.
• If multiple wounds are present, especially when one is infected, a separate wound head should be used for each.
• For patients with known sensitivity to pain or discomfort during wound treatment, topical anesthetics (such as lidocaine jelly 2–4% or EMLA cream) may be prescribed by the treating physician to manage pain.

CONTRAINDICATIONS

• Debridement, including with XSONX®, is not advised for malignant or potentially malignant wounds.
• Patients with advanced peripheral arterial disease (PAD) that hasn’t been revascularized should not undergo debridement with XSONX®.
• According to NPUAP guidelines, heel pressure ulcers that are not infected and have a closed eschar should not be debrided using XSONX®.
• Wounds that are considered pathological or at high risk for pathergy are generally not appropriate for debridement with this system.
• XSONX® should not be used on patients who cannot tolerate pain or for whom pain control is unmanageable.
• It is not intended for internal wounds, wounds with exposed internal structures, or deep penetrating injuries.
• Avoid using XSONX® on wounds near large blood vessels, arteries, or veins, as it could increase the risk of bleeding.
• If bleeding or wound enlargement occurs during use, treatment should be stopped immediately and the physician notified. This could indicate underlying issues such as infection, vascular disease, diabetes, or other chronic conditions.

PRECAUTIONS

• Do not submerge the handpiece in liquid.
• Always clean, disinfect, and inspect the handpiece thoroughly after each use, following proper cleaning protocols.
• Use a new single-use sleeve and wound head for each patient and treatment session.
• When using the curette head, remove the protective cover before treatment and discard the cover and head immediately afterward.

SINGLE-USE POLICY

• Wound heads are meant for single-patient, single-use only, and must not be reused on the same or different patients.
• Handpiece sleeves are also single-use and should not be reused under any circumstances.

MANUAL CLEANING PROCEDURE FOR HANDPIECE

1. Dispose of the used wound head and handpiece sleeve.
2. In a well-ventilated area, clean the handpiece using a Caviwipe:
   • Partially unscrew the back of the handpiece and wipe away visible debris.
   • Use additional wipes or a soft brush (e.g., M16) to remove remaining soil.
3. Allow the device to air dry.
4. Perform disinfection before the next use.

DISINFECTION PROCEDURE

1. Wipe the entire handpiece with a Caviwipe.
2. Keep the surface visibly wet for at least 10 minutes:
   • Focus on areas with cracks or seams.
   • Do not submerge.
   • Loosen the back of the handpiece and wipe thoroughly.
   • Reapply wipes if needed to maintain surface moisture for the full duration.
3. Let the handpiece dry before reuse.

INSPECTION FOR REUSE

• After cleaning and disinfecting, inspect the handpiece carefully for any damage, such as cracks or abrasions.
• If any defect is identified, the device must not be reused.
• Report damage or defects to info@xsonx.com for further instructions.

INSTRUCTIONS FOR USE BY MEDICAL PROFESSIONALS