The NATROX™ system is indicated for chronic non-healing wounds for example leg ulcers, pressure ulcers or any wound that has failed to heal within the expected time frame where underlying causes of non healing have been investigated and addressed and the wound continues to fail to make progress. The device creates an oxygen enriched atmosphere at the wound surface in order to support the patients natural wound healing processes.

The NATROX™ system consists of two items; the NATROX™ Oxygen Generator and the NATROX™ Island Oxygen Delivery Pad (dressing).

The UNIT is used for the duration of the treatment and is a small device worn in a pouch or fitted close to the wound. Moist oxygen is safely generated from the atmosphere and delivered to the dressing. The device works designed to work for the duration of the patient’s treatment and as such the battery pack is rechargeable.

The Dressing is a single-use, sterile, primary dressing with a fine flexible plastic tube for connection to the device. Moist oxygen flows through the tube into the dressing and onto the wound bed.

The design of the dressing ensures an even distribution of oxygen over the wound while maintaining moisture and absorbing exudate helping to reduce or prevent maceration of intact skin adjacent to the wound. The level of exudate can be viewed without removing the dressing by observing strikethrough on the outer surface of the pad as with other dressings. Please note that some wounds respond to Oxygen Wound Therapy by increasing exudate production in the initial stages. As such clinicians should monitor dressings for signs of the exudate exceeding the dressing’s absorption capacity or leakage, and change the dressing when accordingly.

Prior to Use

Follow your local protocol to remove all dressings and expose the wound. Cleanse as per local guidelines if appropriate ensuring that the wound bed is clean and moist. All previously used dressings, ointments and or creams must be removed from the wound bed. Prepare the skin around the wound as required, barrier cream may be considered to protect the surrounding skin from adhesives or exudate if considered appropriate. This is especially important in patients who are at risk from skin sensitivity, or where excess exudate production has been observed to follow earlier applications of Oxygen Wound Therapy.

Dressing Application & Connection

Step 1. Remove the dressing from its packaging and remove the outer skin sealing strips.

Step 2. Position the dressing to cover the wound area. The dressing should be at least 1cm larger than the wound size to ensure good adherence to the surrounding skin.. We currently only have one dressing size as such wounds larger than 10x10cm should not be treated with Oxygen Wound Therapy.

Step 3. Secure the dressing by applying light pressure to the edge of the dressing to create a seal by attaching the adhesive and smoothing out any creases. For maximum benefit, it is essential to avoid visible gaps or creases in the skin seal around the oxygen tube as these allow oxygen to escape reducing the effectiveness of oxygen therapy.

Step 4. Fix and support the tube with a short length of any medical tape close to the dressing. Make further fixings along the tubing where it is comfortable for the patient in terms of managing the tubing. Please be careful to avoid any bony prominences or areas where the patient may sit or stand or lie on for prolonged periods. A tubular bandage may be helpful to secure the tubing on leg wounds.

Step 5. Connect to the NATROX™ UNIT via the twist lock system. Ensure the tube is not kinked. Insert close up of twist lock system

Step 6. To start the NATROX™ UNIT Slide a charged battery to the unit as shown. Ensure the green indicator begins to flash shortly after the battery is attached, this indicates that the device is working and producing oxygen. Connect the tube from the Dressing to the device with a half turn. To stop the devise simply slide out the battery pack. If the green indicator does not flash when a charged battery is fitted oxygen is not being produced. Replace the battery with a fully charged one and place spare on charge for 24 hours.

PLEASE NOTE: The battery should be replaced with a freshly charged battery every 24 hours. We have supply two batteries and a battery charger with each device to facilitate this. We suggest that the patient sets a regular time for changing the battery, mornings or evenings each day.

Patients should be encouraged to wear loose fitting clothes. A pouch is supplied to allow the device to be positioned in various locations on the body preferred by the patient, however it is important to ensure that the small slits around the sides of the device are not obstructed to ensure air can circulate into the unit. Insert picture of small slits

Step 7. The dressing can be left in place for a maximum of seven days. Please ensure that local guidelines are followed or any special instructions for dressing changes are followed and any variances to these are noted in the patients records as appropriate.

A temporary increase in the volume of exudate is a normal feature of the healing process under NATROX™. The dressing should be monitored more frequently than a traditional dressing in the one to two weeks of use.

If the foam pad of the dressing becomes saturated or leakage is seen it must be changed.

Step 8. Removal and change of the Dressing.
The dressing has a mild adhesive edge that is designed to become less adherent with the passage of time. After a few days on the patient’s skin, it should be possible to gently lift the dressing off, taking care not to damage the skin around the wound edge.

Upon removal the dressing should be classed as clinical waste and disposed of as per local policy / guidelines.

The NATROX™ system is contraindicated for the following:

• Ulcers due to thrombophlebitis.
• Ulcers due to Reynauds’s disease.
• Wounds completely covered with eschar/necrosis.
• Wounds with fistulae or deep sinus tracts where the end cannot be probed.
• Wounds covered with petroleum-based dressings.
• Wounds with Inadequate perfusion to support healing.
• Patients who are allergic to any of the components of the dressing / adhesives used.
• Wounds with an area greater than 10x10cm.
• Ulcers resulting from infections, such as tuberculosis, syphilis, deep fungal infections.
• Bites or 3rd degree burns.

The NATROX™ system is to be used and fitted by appropriately qualified health care professionals only, and is for single patient use only. The IODP is a single use dressing and once removed from the wound it should be replaced with a new one.

Do not use any of the components of the system if the packaging has been previously opened or is damaged.

Do not expose NATROX™ unit or its battery to excessive heat and ensure that it is kept dry.

If the patient wishes to shower the NATROX™ unit device must be disconnected from the IODP and the IODP kept dry. NATROX™ unit may be safely reconnected afterwards.

NATROX™ unit should not be sterilised, autoclaved, or flushed with water or any other fluid. The environment inside the NATROX™ unit in which oxygen is generated does not support bacterial or fungal growth.

NATROX™ unit and IODP are only to be used ether and must not be combined with any other devices or products.

NATROX™ unit is single patient, multiple-use and battery powered (rechargeable). The Oxygen Generating cell is sealed and requires no intervention.

Two batteries are provided plus a small charger for mains electricity. The battery powers NATROX™ unit for around 30 hours. It is therefore suggested a battery charging routine is established as a priority. NOTE The battery should be replaced with a freshly charged battery every 24 hours. We suggest that the patient sets a regular time for changing the battery, mornings or evenings whichever is more convenient

When the NATROX™ system is used in conjunction with compression bandaging it is important that the oxygen tube is not compressed against the skin where it may leave a mark. If this seems likely place a small foam pad under the tubing prior to the application of the bandage. Weave the tube out of each layer of the bandaging as soon as possible and finally secure it with tape to the top layer of the bandage in the normal way. Check that the tube is not kinked and that its path out of the bandage does not restrict the flow of oxygen.

Hold NATROX™ unit and placing thumb and finger at the end of the battery, slide it out. Insert one or more picture / video clip of battery removal

Connect the charger to mains supply and connect the battery. A YELLOW light will flash during charging and remain on when fully charged. If the YELLOW light does not flash (charging) or stay onwhen fully charged (after 24 hours) there is a fault.

In both cases: Do not use and report to your Clinician or Inotec AMD, or the designated distributor.

Batteries may be left on charge without concern. A battery should always be on charge ready to use.

The NATROX™ pack contains:

NATROX™ Oxygen Generator
2 x rechargeable batteries
1 x recharging unit
1 x pouch for holding the NATROX™ oxygen generator
1x Instructions for use

If any item is missing, please contact Inotec AMD or your local distributor.

Product codes:

IODP: Part No IODP001
NATROX™ Oxygen generator unit complete: NAT034
NATROX™ Battery: NAT035
PSU Charging unit: NAT006
Extension tube: NA038
Pocket: NA032
Case: NA040
Instructions for use: NA021

If, for any reason, the device has become non functional ( e.g accidental damage) and is to be thrown away, it should be wiped down with an antimicrobial agent, and returned to the manufacturer for recycling of batteries and fuel cell. The return address is shown on the back of this leaflet.

NATROX™ IODP
NATROX™ unit
STERILE R 0088
0088