SAVING LIVES & LIMBS

Instructions for Use
Acutarex PDR 60 Healing System

The Acutarex PDR 60 Healing System is designed to help heal chronic wounds efficiently and effectively. Follow these simple steps daily for optimal results and to ensure proper wound care.

Step 1: Download the Wound Care Buddy App™

The Wound Care Buddy App™ is your daily tool for monitoring wound progress and staying connected with your healthcare provider.
  1. Open the Google Play Store or Apple App Store on your smartphone.
  2. Search for Wound Care Buddy App™ and download it.
  3. Follow the prompts to set up your account.
  4. Use the app daily to:
    • Take photographs of your wound.
    • Monitor progress.
    • Receive alerts and instructions from your healthcare provider.

Step 2: Clean the Wound

Proper cleaning prevents infection and prepares the wound for treatment.
  1. Put on sterile gloves to avoid contamination.
  2. Rinse the wound gently with sterile saline solution.
  3. Make sure the wound is free of debris or exudate.

Step 3: Dry the Wound Area

A dry wound surface helps the treatment work effectively.
  1. Use sterile gauze to gently pat the wound area dry.
  2. Avoid rubbing to prevent irritation or further damage.

Step 4: Apply Wound Prep Spray

The Wound Prep spray helps create a clean environment to promote healing.
  1. After drying the wound, spray the Wound Prep Spray over the wound area.
  2. Use the spray once daily.
  3. Allow it to absorb and dry completely before moving to the next step.

Step 5: Apply the Impregnated Gauze Pad

The specially designed gauze pad delivers the active healing ingredients directly to the wound.
  1. Remove the impregnated gauze pad from its sterile packaging.
  2. Place the gauze gently over the wound, ensuring it covers the entire area.
  3. Use medical tape (provided by your healthcare provider) to secure the gauze in place.

Step 6: Daily Monitoring and Alerts

Monitoring helps track healing progress and catch potential issues early.
  1. Open the Wound Care Buddy App™ daily.
  2. Photograph your wound and log any changes.
  3. Follow any alerts or instructions sent by your healthcare provider.

Step 7: Repeat Daily

Consistency is key to achieving optimal wound healing.
  • Repeat Steps 2 through 6 every day until directed otherwise by your healthcare provider.
Additional Tips for Success
  • Maintain a clean, sterile environment for all wound care activities.
  • Adhere to any specific instructions provided by your healthcare provider.
  • Use the Wound Care Buddy App™ consistently to stay on track.
  • Avoid tobacco and steroid use, as these can hinder the healing process.
Questions or Concerns?
Contact your healthcare provider directly through the Wound Care Buddy App™ or via phone for support.
With daily care and proper use of the Acutarex PDR 60 Healing System, you’ll be on your way to better wound health in no time!
Warnings and Precautions
  • For external use only.
  • Do not use on infected wounds without consulting a physician.
  • Discontinue use if signs of allergic reaction (e.g., rash, itching) occur.
  • Do not reuse gauze pads or tape.
  • Keep out of reach of children.
Contraindications:
  • Not for use on wounds with exposed bone.
  • Avoid use if allergic to any components in the system.
Contents of the Package
  • Wound Prep Spray: [Volume or quantity, e.g., 10 mL bottle]
  • Impregnated Gauze Pads: [Number of pads, e.g., 60 sterile pads]
  • Instructions for Downloading the Wound Care Buddy App™
Not Included but Required:
  • Sterile gloves
  • Sterile saline solution
  • Medical tape
Product Identification
Product Name: Acutarex™ PDR 60 Healing System
Product Code: [Insert Code or SKU Here]
Manufacturer: Alliance Healing Technologies, LLC
Address: [Insert Manufacturer’s Address]
Contact: 1.713.535.9406 | info@alliancehealingtech.com | 400 Austin Ave. Waco, Tx 76701 Suite 102
Purpose/Indication for Use:
The Acutarex™ PDR 60 Healing System is designed to promote healing in chronic wounds such as diabetic ulcers, venous stasis ulcers, and pressure ulcers, combining advanced wound care products with real-time monitoring through the Wound Care Buddy App™.
Storage and Handling
  • Store at room temperature (15°C – 30°C / 59°F – 86°F).
  • Keep in a dry place away from direct sunlight and moisture.
  • Ensure all components remain sealed until use.
Maintenance and Monitoring
  • Regularly check the wound for signs of improvement or deterioration.
  • Attend follow-up appointments as instructed by your healthcare provider.
  • Report any concerns via the app or to your provider directly.
Troubleshooting and Problem-Solving
Issue: Spray nozzle is clogged.
Solution: Rinse nozzle under warm water and test spray again.
Issue: Gauze pad does not adhere securely.
Solution: Use additional medical tape to secure the pad.
Contact your provider if:
  • The wound shows signs of infection (redness, swelling, warmth, or pus).
  • You experience severe pain or an allergic reaction.
Disposal Instructions
  • Dispose of used gauze pads, gloves, and tape in a biohazard container or as directed by your healthcare provider.
  • Recycle packaging materials where facilities exist.
Regulatory and Compliance Information
  • FDA Cleared: K041059: EPI-MAX
  • Lot Number: [Insert Lot Number]
  • Expiration Date: [Insert Expiration Date]
Contact Information
Customer Support: [Insert Phone Number, Email]
App Support: [Insert URL or In-App Help]

Glossary

Exudate
Exudate is fluid that leaks out of blood vessels into nearby tissues as a result of inflammation or injury. It typically contains water, proteins, and cells, including white blood cells, and plays a role in the body’s healing process.
There are different types of exudate, each indicating the stage or severity of the healing or infection process:
  1. Serous Exudate: Thin, clear, and watery, often seen in mild inflammation or during the early stages of healing.
  2. Purulent Exudate (Pus): Thick, yellow, green, or brown, containing dead white blood cells and bacteria, often associated with infections.
  3. Sanguineous Exudate: Red and bloody, indicating damage to blood vessels.
  4. Serosanguineous Exudate: A mixture of serous fluid and blood, light pink in color.
  5. Fibrinous Exudate: Thick and sticky, with high amounts of fibrin protein, often seen in more severe inflammation.
  6. Hemorrhagic Exudate: Contains large amounts of red blood cells, typically seen with significant tissue injury.
Monitoring the type and amount of exudate is essential in wound care to assess healing and detect potential complications.
Impregnated Gauze Pad
A gauze pad pre-treated with active wound-healing compounds.
Medical Tape
A specialized adhesive tape used in healthcare settings to secure bandages, gauze, or other dressings to the skin. Medical tape is designed to be gentle, minimizing irritation while maintaining a strong hold, and is often hypoallergenic and breathable.
PDR (Proteinase Down Regulator )
An advanced wound care technology designed to promote faster healing and reduce complications in chronic and acute wounds. PDR utilizes proprietary formulations and techniques to enhance tissue regeneration, minimize scarring, and improve overall wound outcomes.
Sterile Gauze
A medical-grade fabric made of cotton or synthetic materials, sterilized to eliminate bacteria and other microorganisms. Sterile gauze is used to cover wounds, absorb fluids, and protect the area from infection while promoting a clean healing environment.
Sterile Gloves
Gloves that are free of bacteria, viruses, and other microorganisms. Sterile gloves are used in medical procedures to maintain a clean environment, reduce the risk of infection, and protect both the patient and the wearer from contamination.
Sterile Saline Solution
A medical-grade solution of salt (sodium chloride) dissolved in water, sterilized to remove any bacteria or impurities. Sterile saline is used to clean wounds, flush out debris, and maintain a moist environment to promote healing.
Wound Prep Spray
A solution designed to prepare the wound bed for healing.