Warnings
Follow all warnings and cautions for your selected oxygen source.
Do not operate oxygen near open flames or heat sources.
Cautions
Follow all instructions provided with this dressing.
Do not apply topical or barrier substances to wound during topical oxygen therapy.
Ensure there are no leaks at any connection point in the oxygen pathway.
✓ Indications
Wounds benefiting from continuous Topical Oxygen Therapy (cTOT):
› Chronic wounds
› Acute wounds
✗ Contraindications
› Malignant wounds
› Exposed blood vessels or organs
› Inadequate perfusion / ischemia
› Ulcers due to acute thrombophlebitis
Product Specifications
Six-Step Application Protocol
-
1
Open Package
Do not use if damaged. Handle as Sterile. Peel open pouch at the center. Remove device. No special care required.
Note: Single use only — do not reuse. -
2
Prepare Wound
Remove non-viable tissue and biofilm, cleansing the area, and controlling any signs of infection. Leave wound tissue exposed.
Caution: Do not apply topical substances to wound. It will impair oxygen absorption. -
3
Position Dressing
Place dressing over wound with foam lining placed over and around the wound. Secure with bandage or tape, as preferred.
Note: Dressing may contact intact skin or the wound directly. Tape may be placed at any point on the device. -
4
Secure Dressing
Secure dressing loosely, with a simple bandage, or with tape at no more than 4 locations around the dressing.
Note: The bandage or tape is only to secure the dressing in place, while allowing the oxygen to safely vent out the sides. -
5
Connect Oxygen & Set Flow Rate
Attach the GasPort™ fitting to a humidified oxygen source using a standard respiratory hose. Set oxygen flow rate to 1.0 L/min. Adjust up to 5 L/min for some perineal wounds.
Caution: Confirm gas flow at output of the hose prior to final connection with RashEndZ™. -
6
Verify Functional Operation
Verify that all connection points and the humidification bottle cap are properly sealed, if using a refillable bottle.
Success: Application complete. Dressing is now delivering continuous topical oxygen therapy.
Dressing Changes
When to Change
› Change dressing within 24–72 hours, or as ordered by provider.
› Replace immediately if the fitting is broken and gas flow is compromised.
› Monitor wound progress at each change.
How to Remove
› Disconnect oxygen before removing dressing.
› Gently remove dressing.
› Dispose of used dressing (single use only).
eIFU QR Code
Per EU MDR 2017/745 Article 8 and FDA 21 CFR 801 guidance.